tag:blogger.com,1999:blog-13283131360389015352024-03-14T11:22:51.411-07:00Cancer Clinical TrialsThe knowledge to decide if cancer clinical trials and experimental treatments are right for youAnonymoushttp://www.blogger.com/profile/12607684641176749249noreply@blogger.comBlogger117125tag:blogger.com,1999:blog-1328313136038901535.post-88684459005358345092016-10-02T15:44:00.000-07:002016-10-02T16:53:16.849-07:00Is the Reporting of Cancer Research Usually (or even mostly) Accurate?<br />
<span style="font-family: "arial";">The cancer information site, <i>Cancer.Net</i> has published information to help us everyday health care consumers to judge the sometimes spectacular sounding medical news. </span><span style="font-family: "arial";"><span style="background-color: white; color: #414141; display: inline; float: none; font-family: "arial" , "helvetica" , "nimbus sans l" , sans-serif; font-size: 16.002px; font-style: normal; font-weight: normal; letter-spacing: normal; text-indent: 0px; text-transform: none; white-space: normal; word-spacing: 0px;">Medical news changes <span style="font-family: "arial";">day by day and week by week. If you see terms like "breakthrough" or "life changing drug is discovered,"--be skeptical. The article and claims may be questioned or discredited a week or two from now.</span> <span style="font-family: "arial";">I</span>t is difficult to know what to believe and <span style="font-family: "arial";">whether or not you should do something to take advantage of the "new" information.</span></span></span><br />
<br />
<span style="font-family: "arial";"><a href="http://www.cancer.net/research-and-advocacy/introduction-cancer-research/medical-news-how-know-if-its-accurate" target="_blank">How can you tell if medical news is accurate</a>? That is the question. There are hundreds of news sources--newspapers, magazines, blogs, podcasts, and on and on. They very often provide spectacular, miraculous, and conflicting "facts and figures." Many of us are eager to believe that a "miracle" can happen. But before you fly off to a foreign country for treatment or spend thousands of dollars out of your own pocket, ask some questions and do your homework. </span><br />
<span style="font-family: "arial";"><br /></span>
<span style="font-family: "arial";">Here are a few things you can ask or consider or do...</span><br />
<br />
<span style="font-family: "arial";">1 First of all, check with your doctor and medical team.</span><br />
<span style="font-family: "arial";">2 Find a link to the actual research study site (if there is one).</span><br />
<span style="font-family: "arial";">3 Was the research conducted on animals, humans, or by computer simulation? </span><br />
<span style="font-family: "arial";">4 Was the research reported by the New England Journal of Medicine or Journal of the American Medical Association or the National Cancer Institute? If so, it is more likely to be accurate.</span><br />
<span style="font-family: "arial";">5 Were the results based on extensive human Clinical Trials?</span><br />
<span style="font-family: "arial";">6 Have you considered participating in clinical trials to help get the best research results?</span><br />
<span style="font-family: "arial";">7 Check for FDA approval or the status of the approval process.</span><br />
<span style="font-family: "arial";">8 Does the article report information about risk? There is always risk.</span><br />
<span style="font-family: "arial";">9 Is there concrete evidence of an improved survival benefit?</span><br />
<span style="font-family: "arial";">10 Who stands to get rich if the treatment becomes widely available?</span><br />
<span style="font-family: "arial";">11 Does the research and reporting promise a "cure?" </span><br />
<span style="font-family: "arial";">12 Does the reporting claim the treatment will help everybody with cancer? One size fits all is a highly unlikely outcome. </span><br />
<span style="font-family: "arial";">13 What specific cancer conditions reportedly will be affected by the treatment?</span><br />
<span style="font-family: "arial";">14 Is the reporting based mostly on somebody's "Expert Opinion?" Beware. </span><br />
<span style="font-family: "arial";">15 Even compelling research evidence can take years before treatments become available to patients.</span><br />
<span style="font-family: "arial";"><br /></span>
<span style="font-family: "arial";">Be skeptical, do your homework, and look into available clinical trials in your areas of need and interest. Every FDA approved treatment started as a clinical trial. And many clinical trials that seemed promising never proved effective enough to get FDA approval. </span><br />
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<span style="font-family: "arial";">Post Text Here
</span><br />
<span style="font-family: "arial";">To put a smile on your face see <a href="http://www.cancer-clinical-trials.com/p/clinical-trials-in-cartoons.html">Larry's latest cartoon.</a></span><br />
<span style="font-family: "arial";">To learn more about clinical trials, take a look at <a href="http://tinyurl.com/cancer-clinical-trials-book">our book.</a></span><br />
<span style="font-family: "arial";">
<img height="75" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhAWYLVuUlu5Hq_Elg9pokI-Be5GFY8oe53iScn-8JSTfiAIDtmH6i7dl2al8n7es8vR4Jrb8RyXqdlAqt7geKEY8xbO2ZNy40uOc2nmpEwmUZCXPS2FRWvU4tlD8aTLWiV4kD8dX6S0Kg/s1600/WRITERS.jpg" width="100" /><br />
</span>
(c) 2012 Tom Beer and Larry AxmakerLarry Axmakerhttp://www.blogger.com/profile/03644176927295665033noreply@blogger.com0tag:blogger.com,1999:blog-1328313136038901535.post-49958519633587973672016-08-17T17:37:00.000-07:002016-08-17T17:37:46.858-07:00Are Cancer Clinical Trials becoming more successful?<br /><!--[if gte mso 9]><xml>
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<![endif]--><b style="mso-bidi-font-weight: normal;">First you’ll need to
define ‘SUCCESS.’</b><br />
<b style="mso-bidi-font-weight: normal;"> </b>
<br />
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According to numerous studies and reports, Cancer Clinical
Trials have a very low success rate—somewhere in the <a href="http://www.forbes.com/sites/davidgrainger/2015/01/29/why-too-many-clinical-trials-fail-and-a-simple-solution-that-could-increase-returns-on-pharma-rd/#1329e7cf5f67">5%
to 7% range of all trials that are proposed</a>. This is from Phase 1 (or
pre-phase 1) to eventual FDA approval. This is not so good except that without
even that modest success rate many of us Cancer Survivors would not be surviving.</div>
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Success is often defined in terms of producing an actual
positive impact in treating and managing cancer and increasing cancer survival.
<a href="http://www.cancer.gov/about-cancer/treatment/clinical-trials/what-are-trials">Check
out the National Cancer Institute site</a> for more details. </div>
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<b style="mso-bidi-font-weight: normal;">So are Cancer Clinical
Trials Getting More SUCCESSFUL? YES or NO? </b></div>
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<br /></div>
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<u>If SUCCESS means</u> more experimental results leading to
new and effective drugs—<u>Then NO</u>. (Success rates have not improved in
recent years—they have actually decreased)</div>
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<u>If SUCCESS means</u> more people are volunteering to
participate in trials—<u>Also NO</u>. (Some potentially successful trials never
even get started due to lack of participants)</div>
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<u>If SUCCESS means</u> the trial stages and FDA approval
procedures are progressing more quickly—<u>Definitely NO</u>. (Final FDA
approval can take many years)</div>
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<u>If SUCCESS means</u> ‘affordable’ prescriptions for
cancer patients—<u>Still NO</u>, you’ve got to be kidding (Some well-insured patients
are not even able to afford the co-pays)</div>
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<u>If SUCCESS means</u> weeding out the least promising
drugs in the early stages—<u>Mostly YES</u>. (Ineffective or dangerous drugs
can be replaced with new, more promising experimental drugs)</div>
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<u>If SUCCESS means</u> there will be <i style="mso-bidi-font-style: normal;">some</i> effective new drugs approved for patients—<u>YES, but</u> at a
rather slow pace.</div>
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Over the years we have encouraged our readers to volunteer
for clinical trials when given the opportunity. Your participation could help
you, others, and add to the cancer information base. Many different types of
information can prove to be useful in the study of cancer.</div>
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For example, this author, now with Metastatic-late stage
prostate cancer and in a Chemotherapy regimen, is still participating in
several clinical trials including a study of <span style="mso-spacerun: yes;"> </span>the effect of pain in cancer patients, how cancer
affects quality of life, relationships, etc.</div>
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Cancer Clinical Trials information and data can be useful
even when a particular trial is not successful in curing, treating, or managing
cancer. For example, side-effects you experience may provide information to
help others avoid or manage the same side-effects, allowing a promising trial
to continue. </div>
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Progress in the whole Cancer Clinical Trials world depends
on multiple factors. You have the chance to influence some of these factors by
participating in trials and surveys, sharing medical records, sharing your
cancer experiences, and encouraging and supporting others. Keep on keeping on
and never lose your sense of humor.</div>
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<span style="font-family: arial;">To put a smile on your face see <a href="http://www.cancer-clinical-trials.com/p/clinical-trials-in-cartoons.html">Larry's latest cartoon.</a></span><br />
<span style="font-family: arial;">To learn more about clinical trials, take a look at <a href="http://tinyurl.com/cancer-clinical-trials-book">our book.</a></span><br />
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<img height="75" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhAWYLVuUlu5Hq_Elg9pokI-Be5GFY8oe53iScn-8JSTfiAIDtmH6i7dl2al8n7es8vR4Jrb8RyXqdlAqt7geKEY8xbO2ZNy40uOc2nmpEwmUZCXPS2FRWvU4tlD8aTLWiV4kD8dX6S0Kg/s1600/WRITERS.jpg" width="100" /><br />
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(c) 2012 Tom Beer and Larry AxmakerLarry Axmakerhttp://www.blogger.com/profile/03644176927295665033noreply@blogger.com0tag:blogger.com,1999:blog-1328313136038901535.post-39970191262669692042016-07-20T11:13:00.000-07:002016-07-20T11:13:06.355-07:00Advanced Prostate Cancer--Trials Don't Live Up to Expectations<span style="font-family: "arial";"> Dr. Tom Beer and Dr. Joshi Alumkal, of Oregon Health and Science University, published an editorial in the July 12, 2016 issue of <a href="http://jco.ascopubs.org/content/early/2016/07/07/JCO.2016.68.0439.full" target="_blank">the Journal of Clinical Oncology</a> questioning the value and accuracy of recent Clinical Trials using Docetaxel (a chemotherapy drug) to control symptoms and prolong life in <i>metastatic castration-resistant prostate cancer</i> (mCRPC) patients. Here are some of the topics they covered.</span><br />
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<span style="font-family: "arial";">Since 2004 numerous Phase III clinical trials have used Docetaxel as one part of clinical trials looking for survival advantage in men with advanced prostate cancer. More than half of the trials failed to produce positive results and others produced very weak results. The authors explore how and why this has happened.</span><br />
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<span style="font-family: "arial";">Some trials produce 'statistical' success (e.g. significance) but not much 'clinical' benefit (e.g. a survival benefit of only a month or two). With such a high rate of Phase III failures, it makes sense to change the design of these clinical trials. The authors suggest:</span><br />
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<span style="font-family: "arial";">1 Include the patient in the planning process. What do these men want and expect? What would be a positive outcome for them? What would make them want to volunteer for a clinical trial?</span><br />
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<span style="font-family: "arial";">2 Identify and focus on patients most likely to benefit from a particular drug or treatment. Then design small studies including only those patients.</span><br />
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<span style="font-family: "arial";">3 Determine what success is--improvement in survival, better quality of life, lower risk of toxicity, etc.</span><br />
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<span style="font-family: "arial";">There have been too many failures in mCRPC phase III clinical trials to justify continuing the same procedures again and again. Trials are costly, patients are exposed to potentially toxic agents with little benefit, and marginally effective drugs may be moved toward approval. Studies should focus on providing the greatest likelihood of significantly improving the lives of patients.</span><br />
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</span><br />
<span style="font-family: "arial";">To put a smile on your face see <a href="http://www.cancer-clinical-trials.com/p/clinical-trials-in-cartoons.html">Larry's latest cartoon.</a></span><br />
<span style="font-family: "arial";">To learn more about clinical trials, take a look at <a href="http://tinyurl.com/cancer-clinical-trials-book">our book.</a></span><br />
<span style="font-family: "arial";">
<img height="75" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhAWYLVuUlu5Hq_Elg9pokI-Be5GFY8oe53iScn-8JSTfiAIDtmH6i7dl2al8n7es8vR4Jrb8RyXqdlAqt7geKEY8xbO2ZNy40uOc2nmpEwmUZCXPS2FRWvU4tlD8aTLWiV4kD8dX6S0Kg/s1600/WRITERS.jpg" width="100" /><br />
</span>
(c) 2012 Tom Beer and Larry AxmakerLarry Axmakerhttp://www.blogger.com/profile/03644176927295665033noreply@blogger.com0tag:blogger.com,1999:blog-1328313136038901535.post-3974376378578397632016-06-18T10:50:00.000-07:002016-06-18T10:54:40.236-07:00Dr. Beer leads discussion about Advanced Prostate Cancer--Whats New in 2016 (video)?<b><span style="background-color: white; color: #333333; display: inline; float: none; font-family: "lato" , "trebuchet ms" , "helvetica neue" , "arial" , "liberation sans" , "freesans" , sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: 21px; text-indent: 0px; text-transform: none; white-space: normal; word-spacing: 0px;"><span class="Apple-converted-space"> </span></span></b><span style="font-family: "arial";"><b>What can prostate cancer patients expect from the latest research into advanced prostate cancer treatment? </b></span><br />
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<a class="aQy aZR e aZr" data-tooltip-align="t,c" data-tooltip-class="a1V" data-tooltip="Advanced Prostate Cancer Roundtable Discussion" href="https://www.youtube.com/watch?v=h98SG2_pfPE&authuser=0" id=":1jg" role="link" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;" tabindex="0" target="_blank"><img class="aQG aYB" id=":1jh" src="https://i.ytimg.com/vi/h98SG2_pfPE/mqdefault.jpg" style="bottom: -10%; left: -10%; margin: auto; max-width: 120%; min-width: 100%; position: absolute; right: -10%; top: -10%;" /></a><br />
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ASCO 2016: Advanced Prostate Cancer Roundtable Discussion | Prostate Cancer | Patient Power<br />
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<a href="https://www.youtube.com/watch?">https://www.youtube.com/watch?</a><wbr></wbr><a href="https://www.youtube.com/watch?v=h98SG2_pfPE" target="_blank">Round Table Discussion at ASCO with Dr. Beer</a><br />
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<span class="aZo"><a class="aQy aZR e aZr" data-tooltip-align="t,c" data-tooltip-class="a1V" data-tooltip="Advanced Prostate Cancer Roundtable Discussion" href="https://www.youtube.com/watch?v=h98SG2_pfPE&authuser=0" id=":1jg" role="link" tabindex="0" target="_blank"><span class="a3I" id=":1iq"> </span></a></span><span style="font-family: "arial";"> </span><br />
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<span style="font-family: "arial";">An
expert panel, led by Dr. Tom (Tomasz Beer M.D.), discusses current
research at the 2016 American Society of Clinical Oncology meeting in
Chicago. </span><br />
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</span><br />
<span style="font-family: "arial";">To put a smile on your face see <a href="http://www.cancer-clinical-trials.com/p/clinical-trials-in-cartoons.html">Larry's latest cartoon.</a></span><br />
<span style="font-family: "arial";">To learn more about clinical trials, take a look at <a href="http://tinyurl.com/cancer-clinical-trials-book">our book.</a></span><br />
<span style="font-family: "arial";">
<img height="75" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhAWYLVuUlu5Hq_Elg9pokI-Be5GFY8oe53iScn-8JSTfiAIDtmH6i7dl2al8n7es8vR4Jrb8RyXqdlAqt7geKEY8xbO2ZNy40uOc2nmpEwmUZCXPS2FRWvU4tlD8aTLWiV4kD8dX6S0Kg/s1600/WRITERS.jpg" width="100" /><br />
</span>
(c) 2012 Tom Beer and Larry AxmakerLarry Axmakerhttp://www.blogger.com/profile/03644176927295665033noreply@blogger.com0tag:blogger.com,1999:blog-1328313136038901535.post-9110167588057500782016-06-11T21:24:00.003-07:002016-06-11T21:24:49.671-07:00You may think progress in treating cancer is slow, but....<span style="font-family: arial;"> As someone with stage 4 prostate cancer who is currently undergoing chemotherapy, this author is about as impatient for an effective cancer treatment or even a cure as you can get. But when I look at the history of cancer treatment (or the history of cancer treatment according to the <a href="http://www.cancer.gov/research/progress/250-years-milestones" target="_blank">National Cancer Institute </a>) I can see the incredible advances made--but I'm still impatient.</span><br />
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A few Selected Milestones in Cancer Research and Discovery from the NCI</h3>
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During the past 250 years, we have witnessed many landmark discoveries in the effort to make progress against cancer, an affliction known to humanity for thousands of years. This timeline shows a few key milestones in the history of cancer research.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">1775: Chimney Soot & Squamous Cell Carcinoma</strong></div>
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Percivall Pott identifies a relationship between exposure to chimney soot and the incidence of squamous cell carcinoma of the scrotum among chimney sweeps. His report is the first to clearly link an environmental exposure to the development of cancer. </div>
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(You may wonder why Dr. Pott was examining the scrotums of chimney sweeps....)</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">1863: Inflammation & Cancer</strong></div>
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Rudolph Virchow identifies white blood cells (leukocytes) in cancerous tissue, making the first connection between inflammation and cancer. Virchow also coins the term "leukemia" and is the first person to describe the excess number of white blood cells in the blood of patients with this disease.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">1882: The First Radical Mastectomy to Treat Breast Cancer</strong></div>
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William Halsted performs the first radical mastectomy to treat breast cancer. This surgical procedure remains the standard operation for breast cancer until the latter half of the 20th century.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">1886: Inheritance of Cancer Risk</strong></div>
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Brazilian ophthalmologist Hilário de Gouvêa provides the first documented evidence that a susceptibility to cancer can be inherited from a parent to a child. He reports that two of seven children born to a father who was successfully treated for childhood retinoblastoma, a malignant tumor of the eye, also developed the disease.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">1895: The First X-Ray</strong></div>
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Wilhelm Roentgen discovers X-rays. The first X-ray picture is an image of one of his wife's hands.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">1898: Radium & Polonium</strong></div>
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Marie and Pierre Curie discover the radioactive elements radium and polonium. Within a few years, the use of radium in cancer treatment begins.</div>
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Theodor Boveri proposes that cancerous tumors arise from single cells that have experienced chromosome damage and suggests that chromosome alterations cause the cells to divide uncontrollably.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">1903: The First Use of Radiation Therapy to Cure Cancer</strong></div>
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S.W. Goldberg and Efim London describe the use of radium to treat two patients with basal cell carcinoma of the skin. The disease was eradicated in both patients.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">1909: Immune Surveillance</strong></div>
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"Paul Ehrlich proposes that the immune system usually suppresses tumor formation, a concept that becomes known as the ""immune surveillance"" hypothesis. This proposal prompts research, which continues today, to harness the power of the immune system to fight cancer.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">1911: Cancer in Chickens</strong></div>
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Peyton Rous discovers a virus that causes cancer in chickens (Rous sarcoma virus), establishing that some cancers are caused by infectious agents.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">1915: Cancer in Rabbits</strong></div>
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Katsusaburo Yamagiwa and Koichi Ichakawa induce cancer in rabbits by applying coal tar to their skin, providing experimental proof that chemicals can cause cancer.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">1928: The Pap Smear</strong></div>
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George Papanicolaou discovers that cervical cancer can be detected by examining cells from the vagina under a microscope. This breakthrough leads to the development of the Pap test, which allows abnormal cervical cells to be detected and removed before they become cancerous.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">1932: The Modified Radical Mastectomy for Breast Cancer</strong></div>
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David H. Patey develops the modified radical mastectomy for breast cancer. This surgical procedure is less disfiguring than the radical mastectomy and eventually replaces it as the standard surgical treatment for breast cancer.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">1937: The National Cancer Institute (NCI)</strong></div>
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<u>Legislation signed by President Franklin D. Roosevelt establishes the National Cancer Institute (NCI).</u></div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">1937: Breast-Sparing Surgery Followed by Radiation</strong></div>
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Sir Geoffrey Keynes describes the treatment of breast cancer with breast-sparing surgery followed by radiation therapy. After surgery to remove the tumor, long needles containing radium are inserted throughout the affected breast and near the adjacent axillary lymph nodes.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">1941: Hormonal Therapy</strong></div>
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Charles Huggins discovers that removing the testicles to lower testosterone production or administering estrogens causes prostate tumors to regress. Such hormonal manipulation—more commonly known as hormonal therapy—continues to be a mainstay of prostate cancer treatment.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">1947: Antimetabolites</strong></div>
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Sidney Farber shows that treatment with the antimetabolite drug aminopterin, a derivative of folic acid, induces temporary remissions in children with acute leukemia. Antimetabolite drugs are structurally similar to chemicals needed for important cellular processes, such as DNA synthesis, and cause cell death by blocking those processes.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">1949: Nitrogen Mustard</strong></div>
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The Food and Drug Administration (FDA) approves nitrogen mustard (mechlorethamine) for the treatment of cancer. Nitrogen mustard belongs to a class of drugs called alkylating agents, which kill cells by chemically modifying their DNA.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">1950: Cigarette Smoking & Lung Cancer</strong></div>
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Ernst Wynder, Evarts Graham, and Richard Doll identify cigarette smoking as an important factor in the development of lung cancer.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">1953: The First Complete Cure of a Human Solid Tumor</strong></div>
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Roy Hertz and Min Chiu Li achieve the first complete cure of a human solid tumor by chemotherapy when they use the drug methotrexate to treat a patient with choriocarcinoma, a rare cancer of the reproductive tissue that mainly affects women.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">1958: Combination Chemotherapy</strong></div>
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NCI researchers Emil Frei, Emil Freireich, and James Holland and their colleagues demonstrate that combination chemotherapy with the drugs 6-mercaptopurine and methotrexate can induce partial and complete remissions and prolong survival in children and adults with acute leukemia.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">1960: The Philadelphia Chromosome</strong></div>
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Peter Nowell and David Hungerford describe an unusually small chromosome in the cancer cells of patients with chronic myelogenous leukemia (CML). This chromosome, which becomes known as the Philadelphia chromosome, is found in the leukemia cells of 95% of patients with CML.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">1964: A Focus on Cigarette Smoking</strong></div>
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The U.S. Surgeon General issues a report stating that cigarette smoking is an important health hazard in the United States and that action is required to reduce its harmful effects.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">1964: The Epstein-Barr virus</strong></div>
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For the first time, a virus—the Epstein-Barr virus (EBV)—is linked to a human cancer (Burkitt lymphoma). EBV is later shown to cause several other cancers, including nasopharyngeal carcinoma, Hodgkin lymphoma, and some gastric (stomach) cancers.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">1971: The National Cancer Act</strong></div>
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On December 23, President Richard M. Nixon signs the National Cancer Act, which authorizes the NCI Director to coordinate all activities of the National Cancer Program, establish national cancer research centers, and establish national cancer control programs.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">1976: The DNA of Normal Chicken Cells</strong></div>
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Dominique Stehelin, Harold Varmus, J. Michael Bishop, and Peter Vogt discover that the DNA of normal chicken cells contains a gene related to the oncogene (cancer-causing gene) of avian sarcoma virus, which causes cancer in chickens. This finding eventually leads to the discovery of human oncogenes.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">1978: Tamoxifen</strong></div>
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The Food and Drug Administration (FDA) approves tamoxifen, an antiestrogen drug originally developed as a birth control treatment, for the treatment of breast cancer. Tamoxifen represents the first of a class of drugs known as selective estrogen receptor modulators, or SERMs, to be approved for cancer therapy.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">1979: The TP53 Gene</strong></div>
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The TP53 gene (also called p53), the most commonly mutated gene in human cancer, is discovered. It is a tumor suppressor gene, meaning its protein product (p53 protein) helps control cell proliferation and suppress tumor growth.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">1984: HER2 Oncogene Identified</strong></div>
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Researchers discover a new oncogene in rat cells that they call “neu.” The human version of this gene, called HER2 (and ErbB2), is overexpressed in about 20% to 25% of breast cancers (known as HER2-positive breast cancers) and is associated with more aggressive disease and a poor prognosis.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">1984: HPV 16 & 18</strong></div>
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DNA from human papillomavirus (HPV) types 16 and 18 is identified in a large percentage of cervical cancers, establishing a link between infection with these HPV types and cervical carcinogenesis.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">1985: Breast-Conserving Surgery</strong></div>
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Results from an NCI-supported clinical trial show that women with early-stage breast cancer who were treated with breast-conserving surgery (lumpectomy) followed by whole-breast radiation therapy had similar rates of overall survival and disease-free survival as women who were treated with mastectomy alone.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">1986: HER2 Oncogene Cloning</strong></div>
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The human oncogene HER2 (also called neu and erbB2) is cloned. Overexpression of the protein product of this gene, which occurs in about 20% to 25% of breast cancers (known as HER2-positive breast cancers), is associated with more aggressive disease and a poor prognosis.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">1993: Guaiac Fecal Occult Blood Testing (FOBT)</strong></div>
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Results from an NCI-supported clinical trial show that annual screening with guaiac fecal occult blood testing (FOBT) can reduce colorectal cancer mortality by about 33%.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">1994: BRCA1 Tumor Suppressor Gene Cloning</strong></div>
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The tumor suppressor gene BRCA1 is cloned. Specific inherited mutations in this gene greatly increase the risks of breast and ovarian cancer in women and the risks of several other cancers in both men and women.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">1995: BRCA2 Tumor Suppressor Gene Cloning</strong></div>
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The tumor suppressor gene BRCA2 is cloned. Similar to BRCA1, inheriting specific BRCA2 gene mutations greatly increases the risks of breast and ovarian cancer in women and the risks of several other cancers in both men and women.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">1996: Anastrozole</strong></div>
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The Food and Drug Administration (FDA) approves anastrozole for the treatment of estrogen receptor-positive advanced breast cancer in postmenopausal women. Anastrozole is the first aromatase inhibitor (a drug that blocks the production of estrogen in the body) to be approved for cancer therapy.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">1997: Rituximab</strong></div>
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The Food and Drug Administration (FDA) approves rituximab, a monoclonal antibody, for use in patients with treatment-resistant, low-grade or follicular B-cell non-Hodgkin lymphoma (NHL). Rituximab is later approved as an initial treatment for these types of NHL, for another type of NHL called diffuse large B-cell lymphoma, and for chronic lymphocytic leukemia.</div>
<div style="-webkit-text-stroke-width: 0px; background-color: #fffffb; border: 0px; box-sizing: border-box; color: #2e2e2e; direction: ltr; font-family: "Noto Sans", Arial, sans-serif; font-size: 16px; font-stretch: inherit; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: 1.5em; margin: 1.25em 0px; orphans: auto; padding: 0px; text-align: start; text-indent: 0px; text-rendering: optimizeLegibility; text-transform: none; vertical-align: baseline; white-space: normal; widows: 1; word-spacing: 0px;">
<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">1998: NCI-Sponsored Breast Cancer Prevention Trial</strong></div>
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Results of the NCI-sponsored Breast Cancer Prevention Trial show that the antiestrogen drug tamoxifen can reduce the incidence of breast cancer among women who are at increased risk of the disease by about 50%. The Food and Drug Administration (FDA) approves tamoxifen to reduce the incidence of breast cancer in women at increased risk.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">1998: Trastuzumab</strong></div>
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The Food and Drug Administration (FDA) approves trastuzumab, a monoclonal antibody that targets cancer cells that overproduce the protein HER2, for the treatment of women with HER2-positive metastatic breast cancer. Trastuzumab is later approved for the adjuvant (post-operative) treatment of women with HER2-positive early-stage breast cancer.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">2001: Imatinib Mesylate</strong></div>
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Results of a clinical trial show that the drug imatinib mesylate, which targets a unique protein produced by the Philadelphia chromosome, is effective against chronic myelogenous leukemia (CML). Later, it is also shown to be effective in the treatment of gastrointestinal stromal tumors (GIST).</div>
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(Does the name Dr. Brian Druker sound familiar?)</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">2003: NCI-Sponsored Prostate Cancer Prevention Trial (PCPT)</strong></div>
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Results of the NCI-sponsored Prostate Cancer Prevention Trial (PCPT) show that the drug finasteride, which reduces the production of male hormones in the body, lowers a man's risk of prostate cancer by about 25%.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">2006: NCI's Study of Tamoxifen and Raloxifene (STAR)</strong></div>
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Results of NCI's Study of Tamoxifen and Raloxifene (STAR) show that postmenopausal women at increased risk of breast cancer can reduce their risk of developing the disease if they take the antiestrogen drug raloxifene. The risk of serious side effects is lower with raloxifene than with tamoxifen.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">2006: Gardasil</strong></div>
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The Food and Drug Administration (FDA) approves the human papilloma virus (HPV) vaccine Gardasil, which protects against infection by the two types of HPV that cause approximately 70% of all cases of cervical cancer. NCI scientists developed the underlying technology used to make Gardasil.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">2009: Cervarix</strong></div>
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The Food and Drug Administration (FDA) approves Cervarix, a second vaccine that protects against infection by the two types of the human papilloma virus (HPV) that cause approximately 70% of all cases of cervical cancer worldwide. NCI scientists developed the underlying technology used to make Cervarix.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">2010: The First Human Cancer Treatment Vaccine</strong></div>
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The Food and Drug Administration (FDA) approves sipuleucel-T, a cancer treatment vaccine that is made using a patient's own immune system cells (dendritic cells), for the treatment of metastatic prostate cancer that no longer responds to hormonal therapy. It is the first (and so far only) human cancer treatment vaccine to be approved.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">2010: NCI-Sponsored Lung Cancer Screening Tiral (NLST)</strong></div>
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Initial results of the NCI-sponsored Lung Cancer Screening Trial (NLST) show that screening with low-dose helical computerized tomography (CT) reduced lung cancer deaths by about 20% in a large group of current and former heavy smokers.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">2011: Ipilimumab</strong></div>
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The Food and Drug Administration (FDA) approves the use of ipilimumab, a monoclonal antibody, for the treatment of inoperable or metastatic melanoma. Ipilimumab stimulates the immune system to attack cancer cells by removing a "brake" that normally controls the intensity of immune responses.</div>
<div style="-webkit-text-stroke-width: 0px; background-color: #fffffb; border: 0px; box-sizing: border-box; color: #2e2e2e; direction: ltr; font-family: "Noto Sans", Arial, sans-serif; font-size: 16px; font-stretch: inherit; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: 1.5em; margin: 1.25em 0px; orphans: auto; padding: 0px; text-align: start; text-indent: 0px; text-rendering: optimizeLegibility; text-transform: none; vertical-align: baseline; white-space: normal; widows: 1; word-spacing: 0px;">
<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">2012: NCI-Sponsored PLCO Cancer Screening Trial</strong></div>
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Results of the NCI-sponsored PLCO Cancer Screening Trial confirm that screening people 55 years of age and older for colorectal cancer using flexible sigmoidoscopy reduces colorectal cancer incidence and mortality. In the PLCO, screened individuals had a 21% lower risk of developing colorectal cancer and a 26% lower risk of dying from the disease than the control subjects.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">2013: Ado-Trastuzumab Emtansine (T-DM1)</strong></div>
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The FDA approves ado-trastuzumab emtansine (T-DM1) for the treatment of patients with HER2-positive breast cancer who were previously treated with trastuzumab and/or a taxane drug. T-DM1 is an immunotoxin (an antibody-drug conjugate) that is made by chemically linking the monoclonal antibody trastuzumab to the cytotoxic agent mertansine, which inhibits cell proliferation by blocking the formation of microtubules.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">2014: Analyzing DNA in Cancer</strong></div>
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Researchers from The Cancer Genome Atlas (TCGA) project, a joint effort by NCI and the National Human Genome Research Institute to analyze the DNA and other molecular changes in more than 30 types of human cancer, find that gastric (stomach) cancer is actually four different diseases, not just one, based on differing tumor characteristics. This finding from TCGA and other related projects may potentially lead to a new classification system for cancer, in which cancers are classified by their molecular abnormalities as well as their organ or tissue site of origin.</div>
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<strong style="border: 0px; box-sizing: border-box; font-family: inherit; font-size: inherit; font-stretch: inherit; font-style: inherit; font-variant: inherit; font-weight: bold; line-height: inherit; margin: 0px; padding: 0px; vertical-align: baseline;">2014: Pembrolizumab</strong></div>
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The FDA approves pembrolizumab for the treatment of advanced melanoma. This monoclonal antibody blocks the activity of a protein called PD1 on immune cells, which increases the strength of immune responses against cancer.</div>
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<span style="font-family: arial;">To put a smile on your face see <a href="http://www.cancer-clinical-trials.com/p/clinical-trials-in-cartoons.html">Larry's latest cartoon.</a></span><br />
<span style="font-family: arial;">To learn more about clinical trials, take a look at <a href="http://tinyurl.com/cancer-clinical-trials-book">our book.</a></span><br />
<span style="font-family: arial;">
<img height="75" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhAWYLVuUlu5Hq_Elg9pokI-Be5GFY8oe53iScn-8JSTfiAIDtmH6i7dl2al8n7es8vR4Jrb8RyXqdlAqt7geKEY8xbO2ZNy40uOc2nmpEwmUZCXPS2FRWvU4tlD8aTLWiV4kD8dX6S0Kg/s1600/WRITERS.jpg" width="100" /><br />
</span>
(c) 2012 Tom Beer and Larry AxmakerLarry Axmakerhttp://www.blogger.com/profile/03644176927295665033noreply@blogger.com0tag:blogger.com,1999:blog-1328313136038901535.post-11053936164385299952016-01-31T19:02:00.001-08:002016-01-31T19:02:40.396-08:00A letter from Senator Wyden to drug giant Gilead <span style="font-family: arial;"><!--[if gte mso 9]><xml>
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We’ve posted several articles/editorials about high and
seemingly eternally rising drug costs. Doctors, patients, and more recently,
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In December, the U.S. Senate Finance Committee released a
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In a rather long <a href="http://www.finance.senate.gov/imo/media/doc/Wyden-Grassley%20Document%20Request%20to%20Gilead%207-11-141.pdf">open
letter</a> to drug manufacturer Gilead, Senate Finance Committee Chairman
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<br />
<span style="font-family: arial;">Post Text Here
</span><br />
<span style="font-family: arial;">To put a smile on your face see <a href="http://www.cancer-clinical-trials.com/p/clinical-trials-in-cartoons.html">Larry's latest cartoon.</a></span><br />
<span style="font-family: arial;">To learn more about clinical trials, take a look at <a href="http://tinyurl.com/cancer-clinical-trials-book">our book.</a></span><br />
<span style="font-family: arial;">
<img height="75" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhAWYLVuUlu5Hq_Elg9pokI-Be5GFY8oe53iScn-8JSTfiAIDtmH6i7dl2al8n7es8vR4Jrb8RyXqdlAqt7geKEY8xbO2ZNy40uOc2nmpEwmUZCXPS2FRWvU4tlD8aTLWiV4kD8dX6S0Kg/s1600/WRITERS.jpg" width="100" /><br />
</span>
(c) 2012 Tom Beer and Larry AxmakerLarry Axmakerhttp://www.blogger.com/profile/03644176927295665033noreply@blogger.com0tag:blogger.com,1999:blog-1328313136038901535.post-12700036660380015502015-12-23T11:25:00.001-08:002015-12-23T12:25:48.305-08:00A Modest/Radical Proposal<br />
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<![endif]--><b style="mso-bidi-font-weight: normal;">Are you paying more
for effective drugs and less for less effective drugs? Probably not…</b><br />
<b style="mso-bidi-font-weight: normal;"> </b>
<br />
<div class="MsoNormal">
It seems the discussion surrounding cancer drug costs is
never ending and never changing. Patients and doctors complain, articles are
written, and drug prices continue to go up—rapidly.</div>
<div class="MsoNormal">
<a href="https://www.mskcc.org/profile/peter-bach">Peter B.
Bach</a>, a Director at Memorial Sloan Kettering Cancer Center, recently
published an article in the <a href="https://hbr.org/2015/10/a-new-way-to-define-value-in-drug-pricing">Harvard
Business Review</a> proposing a new way to define drug pricing. We suggest you
read the whole article.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
In a nutshell, Dr. Bach proposes that patients and insurance
companies pay for drugs based on how well they actually work (better quality of
life, modest side effects, and longer lifespan). More effective drugs would
continue to demand high costs and less effective drugs would cost less. Sounds
reasonable doesn’t it?</div>
<div class="MsoNormal">
<br /></div>
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This, of course, is easier said than done. It costs drug
companies just as much to develop a drug whether or not it is effective or even
if it duplicates what another drug does.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Many cancer drugs now retail for $100,000 a year or much
more. The prices are going up every year whether that drug is working for you
or not. So it seems logical not to pay incredibly high prices for a drug that
does little to keep you alive or symptom free. </div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Some drugs work better for some people than others. How do
you price those drugs? Who decides how ‘effective’ a drug is? Should it be the
patient, doctor, or drug company? What if you take two or three drugs? How do
you determine which is most effective or least effective? How do you measure
the impact of drug side effects? There are many questions to answer before
something like this could ever happen. And drug companies are still free to
charge whatever they decide will be accepted by the market.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
This is something to think about. It may be just fantasy. Watch
for future research and articles about “paying for value.”</div>
<div class="MsoNormal">
<br /></div>
<br />
<br />
<span style="font-family: arial;">Post Text Here
</span><br />
<span style="font-family: arial;">To put a smile on your face see <a href="http://www.cancer-clinical-trials.com/p/clinical-trials-in-cartoons.html">Larry's latest cartoon.</a></span><br />
<span style="font-family: arial;">To learn more about clinical trials, take a look at <a href="http://tinyurl.com/cancer-clinical-trials-book">our book.</a></span><br />
<span style="font-family: arial;">
<img height="75" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhAWYLVuUlu5Hq_Elg9pokI-Be5GFY8oe53iScn-8JSTfiAIDtmH6i7dl2al8n7es8vR4Jrb8RyXqdlAqt7geKEY8xbO2ZNy40uOc2nmpEwmUZCXPS2FRWvU4tlD8aTLWiV4kD8dX6S0Kg/s1600/WRITERS.jpg" width="100" /><br />
</span>
(c) 2012 Tom Beer and Larry AxmakerLarry Axmakerhttp://www.blogger.com/profile/03644176927295665033noreply@blogger.com0tag:blogger.com,1999:blog-1328313136038901535.post-2196700046414831112015-11-07T18:01:00.002-08:002015-11-07T18:01:28.882-08:00Clinical Trials, Big Pharma, the FDA, and Expen$ive Drugs<!--[if gte mso 9]><xml>
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<![endif]--><b style="mso-bidi-font-weight: normal;">...turns out this is
not always a great combination for patients</b><br />
<b style="mso-bidi-font-weight: normal;"> </b>
<br />
<div class="MsoNormal">
Many of us, including this author, are taking one or more of
the new and very expensive cancer drugs in our attempt to live longer and have
a better quality of life. New and expensive does not necessarily mean we will
live longer and better, however. We keep doing this (at least I do) because
there is not much in the way of alternatives. We seem to be at the mercy of the
most powerful companies in the U.S.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
In a new book, <a href="https://jhupbooks.press.jhu.edu/content/ending-medical-reversal">Ending Medical
Reversal: Improving Outcomes and Saving Lives</a>, Dr. Vinay Prasad looks at
ever increasing prices, secretive clinical trial results, questionable procedures,
and low drug effectiveness in dozens of the new cancer drugs on the market. <a href="http://www.ohsu.edu/xd/health/services/providers/index.cfm?personID=3273">Dr.
Prasad</a> is an Associate Professor of Medicine at <a href="http://www.ohsu.edu/xd/health/services/cancer/">OHSU</a>.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Here are some <a href="https://www.psychologytoday.com/blog/saving-normal/201510/why-are-most-cancer-drugs-so-expensive-and-so-ineffective">excerpts</a>
from Dr. Prasad’s book in his own words:</div>
<div style="line-height: 19.5pt; margin-bottom: .25in; margin-left: 0in; margin-right: 0in; margin-top: 0in;">
<i style="mso-bidi-font-style: normal;"><span style="color: black;">"Cancer drugs are outrageously expensive; but they are
worth every penny, right?</span></i></div>
<div style="-webkit-text-stroke-width: 0px; line-height: 19.5pt; margin-bottom: .25in; margin-left: 0in; margin-right: 0in; margin-top: 0in; orphans: auto; text-align: start; widows: 1; word-spacing: 0px;">
<i style="mso-bidi-font-style: normal;"><span style="color: black;">When you pay a lot for something, you want it to be great. This is true
of a new car, a new computer, a new pair of shoes—but it doesn’t seem to be
true for cancer drugs.</span></i></div>
<div style="-webkit-text-stroke-width: 0px; line-height: 19.5pt; margin-bottom: .25in; margin-left: 0in; margin-right: 0in; margin-top: 0in; orphans: auto; text-align: start; widows: 1; word-spacing: 0px;">
<i style="mso-bidi-font-style: normal;"><span style="color: black;">Recently, we heard that profiteers are raising the price of old,
established medicines. For many Americans, <a href="http://www.forbes.com/sites/luketimmerman/2015/09/23/a-timeline-of-the-turing-pharma-controversy/">Turing
pharmaceutical</a> and <a href="http://www.reuters.com/article/2015/10/07/us-shkreli-turing-idUSKCN0S12OO20151007">Martin
Shkreli</a> have become four letter words.</span></i></div>
<div style="-webkit-text-stroke-width: 0px; line-height: 19.5pt; margin-bottom: .25in; margin-left: 0in; margin-right: 0in; margin-top: 0in; orphans: auto; text-align: start; widows: 1; word-spacing: 0px;">
<i style="mso-bidi-font-style: normal;"><span style="color: black;">But the problem of inappropriate prices is not just a few exceptional
cases; it is the norm in cancer medicine.</span></i></div>
<div style="-webkit-text-stroke-width: 0px; line-height: 19.5pt; margin-bottom: .25in; margin-left: 0in; margin-right: 0in; margin-top: 0in; orphans: auto; text-align: start; widows: 1; word-spacing: 0px;">
<i style="mso-bidi-font-style: normal;"><span style="color: black;">Before we talk price tag, let’s consider what we get for our money. In
medicine, there is always nuance, and it exists here. For example, there are
some excellent cancer drugs. Two that come to mind are imatinib—a revolutionary
pill that transformed a highly fatal leukemia into a manageable condition—and
rituximab—a monoclonal antibody that has improved survival in several cancers.
These drugs are expensive, sure, but no one can say they aren’t terrific. But
we can say that Novartis, the maker of Gleevec, has raised the price of the
drug from an already high $30,000 in 2001 to $76,000 today despite the fact
that it costs less than $200 dollars to manufacture a year's supply.</span></i></div>
<div style="-webkit-text-stroke-width: 0px; line-height: 19.5pt; margin-bottom: .25in; margin-left: 0in; margin-right: 0in; margin-top: 0in; orphans: auto; text-align: start; widows: 1; word-spacing: 0px;">
<i style="mso-bidi-font-style: normal;"><span style="color: black;">But at least Gleevec is a great drug. Most cancer drugs are not close to
being great—they have only a tiny positive impact on longevity and often cause
many side effects.</span></i></div>
<div style="-webkit-text-stroke-width: 0px; line-height: 19.5pt; margin-bottom: .25in; margin-left: 0in; margin-right: 0in; margin-top: 0in; orphans: auto; text-align: start; widows: 1; word-spacing: 0px;">
<i style="mso-bidi-font-style: normal;"><span style="color: black;">The median improvement in survival for 71 drugs approved by the US Food
and Drug Administration for treating solid cancers over the last decade is only
2.1 months. And there are two good reasons to assume that this remarkably short
reported extension is in fact an overestimate. First, the average age of cancer
patients in the real world is much older than those included in the studies
submitted to the FDA —60% of cancer patients are over 65, but they account for
just 36% of patients in key trials. Older patients—who are frailer and have
other medical problems—experience more side effects from cancer drugs and less
benefit.</span></i></div>
<div style="-webkit-text-stroke-width: 0px; line-height: 19.5pt; margin-bottom: .25in; margin-left: 0in; margin-right: 0in; margin-top: 0in; orphans: auto; text-align: start; widows: 1; word-spacing: 0px;">
<i style="mso-bidi-font-style: normal;"><span style="color: black;">Second, the majority of cancer drugs approved by the FDA are not
included in the 2.1 month figure, because their effects on overall survival are
unknown. Amazingly, most new drugs (2/3s) are approved on the basis of
improvement of a surrogate endpoint—e.g. a new drug shrinks a tumor on a CT
scan. We don't know that this shrinkage actually translates into a longer or a
better life.</span></i></div>
<div style="-webkit-text-stroke-width: 0px; line-height: 19.5pt; margin-bottom: .25in; margin-left: 0in; margin-right: 0in; margin-top: 0in; orphans: auto; text-align: start; widows: 1; word-spacing: 0px;">
<i style="mso-bidi-font-style: normal;"><span style="color: black;">So, the efficacy of most cancer drugs is minimal and may be even less in
the real world. How do we then explain why they are already so ridiculously
expensive and increasing in cost at a rate of 10% a year. Cancer drugs now
routinely cost more than 100,000 dollars for one year of treatment.</span></i></div>
<div style="-webkit-text-stroke-width: 0px; line-height: 19.5pt; margin-bottom: .25in; margin-left: 0in; margin-right: 0in; margin-top: 0in; orphans: auto; text-align: start; widows: 1; word-spacing: 0px;">
<i style="mso-bidi-font-style: normal;"><span style="color: black;">One way doctors measure the value of drugs is to ask how much is the
total drug cost to get us 1 year of quality life. Since most drugs just
add a few weeks or months, you have to treat many people to get just one year
of extra life. By this measure, most cancer drugs are outrageously expensive. A
new breast cancer drug costs ~$700,000 for a quality adjusted life year, and a
new colon cancer drug costs $900,000. And these figures apply only if you give
the drug the benefit of the doubt, and assume it works as well in the real
world as it does in FDA studies.</span></i></div>
<div style="-webkit-text-stroke-width: 0px; line-height: 19.5pt; margin-bottom: .25in; margin-left: 0in; margin-right: 0in; margin-top: 0in; orphans: auto; text-align: start; widows: 1; word-spacing: 0px;">
<i style="mso-bidi-font-style: normal;"><span style="color: black;">Not surprisingly, Pharma is our most profitable industry—double digit
returns ranging from 10% to 42% are routine, despite the overall disappointing
benefits of their products.</span></i></div>
<div style="-webkit-text-stroke-width: 0px; line-height: 19.5pt; margin-bottom: .25in; margin-left: 0in; margin-right: 0in; margin-top: 0in; orphans: auto; text-align: start; widows: 1; word-spacing: 0px;">
<i style="mso-bidi-font-style: normal;"><span style="color: black;">Reasonable people would say it’s fine to make a tidy profit when you
make a great drug—a drug like Gleevec. But we might also say it doesn’t seem
fair to keep raising its price over time, as the cost to make it is trivial,
and the research and development are already done. Steep price increases feel
like profiteering.</span></i></div>
<div style="-webkit-text-stroke-width: 0px; line-height: 19.5pt; margin-bottom: .25in; margin-left: 0in; margin-right: 0in; margin-top: 0in; orphans: auto; text-align: start; widows: 1; word-spacing: 0px;">
<i style="mso-bidi-font-style: normal;"><span style="color: black;">Reasonable people might also say that it doesn’t seem right to pay so
much for drugs that add so little—and only add that little bit under just right
conditions. Especially when the costs to make drugs are so low and profits are
so high.</span></i></div>
<div style="-webkit-text-stroke-width: 0px; line-height: 19.5pt; margin-bottom: .25in; margin-left: 0in; margin-right: 0in; margin-top: 0in; orphans: auto; text-align: start; widows: 1; word-spacing: 0px;">
<i style="mso-bidi-font-style: normal;"><span style="color: black;">What prevents us from being reasonable people? That is not just a
million dollar question, but a tens of billion dollar one. It involves rules
that prevent Medicare from negotiating the price of drugs and the intricacies
of the patent system. Solutions won’t be simple or easy, but the price of
cancer drugs is way too high, and we get far too little for it. The time for
reform is now."</span></i></div>
<div class="MsoNormal">
As someone who is about to embark on yet another expensive cancer
drug experience I applaud Dr. Prasad. I wish him well and hope he can convince
enough of the right people (maybe even Congress) to take another look and maybe
even take action to decrease drug costs. My life, and many of yours, may depend
on it. </div>
<div class="MsoNormal">
<br /></div>
<span style="font-family: arial;"> </span><br />
<span style="font-family: arial;">Post Text Here
</span><br />
<span style="font-family: arial;">To put a smile on your face see <a href="http://www.cancer-clinical-trials.com/p/clinical-trials-in-cartoons.html">Larry's latest cartoon.</a></span><br />
<span style="font-family: arial;">To learn more about clinical trials, take a look at <a href="http://tinyurl.com/cancer-clinical-trials-book">our book.</a></span><br />
<span style="font-family: arial;">
<img height="75" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhAWYLVuUlu5Hq_Elg9pokI-Be5GFY8oe53iScn-8JSTfiAIDtmH6i7dl2al8n7es8vR4Jrb8RyXqdlAqt7geKEY8xbO2ZNy40uOc2nmpEwmUZCXPS2FRWvU4tlD8aTLWiV4kD8dX6S0Kg/s1600/WRITERS.jpg" width="100" /><br />
</span>
(c) 2012 Tom Beer and Larry AxmakerLarry Axmakerhttp://www.blogger.com/profile/03644176927295665033noreply@blogger.com0tag:blogger.com,1999:blog-1328313136038901535.post-82206160420983748012015-10-25T09:14:00.001-07:002015-10-25T09:14:17.657-07:00The World’s Largest Cancer Clinical Trial<br />
The creation of cancer treatment drugs often follows a
similar path. Somewhere a researcher or research team independently or as part
of a drug company invents a potentially effective drug and a drug company
sponsors clinical trials. After many trials at several levels, involving
hundreds and maybe thousands of patients, some of the drugs are FDA approved. Conducting
clinical trials is expensive and the successful drugs are eventually sold to
patients at very high prices. You already know this, of course. But this new clinical
trial from the UK has a different twist.<br />
<br />
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<b style="mso-bidi-font-weight: normal;">Clinical trials on
the cheap</b></div>
<div class="MsoNormal">
The <a href="http://www.bbc.com/news/health-34592242">BBC</a>
has reported that Cancer Research UK and NIHR (part of the National Health
Service) will be sponsoring a 12-year study of the cancer prevention benefits
of ASPIRIN. Yes, common aspirin. It is called the <a href="http://www.addaspirintrial.org/treatment_in_the_trial">Add-Aspirin Trial</a>. </div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
There has been some research to suggest that aspirin can
delay or slow the growth of some cancers. This trial will help determine if
aspirin can be an effective cancer treatment. A proven inexpensive cancer
treatment would be a major benefit to millions. </div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
11,000 people with early stage cancer—the largest number
ever in a clinical trial‑‑will be randomly assigned to one of four groups. One group
will take a daily placebo and the other three groups will each take aspirin at
a different dosage level. This part of the study will last five years. Participants
will be monitored for as long as 12 years. Patients with early stage bowel,
breast, prostate, stomach, and esophageal cancers will be included in the
study. </div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Aspirin is one of the cheapest meds on the market. It was
originally developed as a painkiller but is now widely used to help reduce the
risk of heart attack and stroke. Maybe there is one more chapter in the aspirin
story. </div>
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<br /></div>
<div class="MsoNormal">
Aspirin has several documented side effects—as do all drugs‑‑
and would not be appropriate for everyone.</div>
<div class="MsoNormal">
<br /></div>
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Keep an eye on this study. Not all clinical studies have a
good outcome but, if successful, this one <i style="mso-bidi-font-style: normal;">could</i> be a ‘game changer.’</div>
<div class="MsoNormal">
<br /></div>
<br />
<span style="font-family: arial;">Post Text Here
</span><br />
<span style="font-family: arial;">To put a smile on your face see <a href="http://www.cancer-clinical-trials.com/p/clinical-trials-in-cartoons.html">Larry's latest cartoon.</a></span><br />
<span style="font-family: arial;">To learn more about clinical trials, take a look at <a href="http://tinyurl.com/cancer-clinical-trials-book">our book.</a></span><br />
<span style="font-family: arial;">
<img height="75" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhAWYLVuUlu5Hq_Elg9pokI-Be5GFY8oe53iScn-8JSTfiAIDtmH6i7dl2al8n7es8vR4Jrb8RyXqdlAqt7geKEY8xbO2ZNy40uOc2nmpEwmUZCXPS2FRWvU4tlD8aTLWiV4kD8dX6S0Kg/s1600/WRITERS.jpg" width="100" /><br />
</span>
(c) 2012 Tom Beer and Larry AxmakerLarry Axmakerhttp://www.blogger.com/profile/03644176927295665033noreply@blogger.com0tag:blogger.com,1999:blog-1328313136038901535.post-73192383508944382252015-09-28T17:37:00.000-07:002015-09-28T17:37:06.151-07:00Cancer Treatment Drugs Approved in 2014 and 2015 by the FDA<span style="font-family: arial;">Looking for the latest and greatest medications to treat your cancer? There are a number of drugs approved by the FDA in the past two years and listed by <a href="https://www.centerwatch.com/drug-information/fda-approved-drugs/therapeutic-area/12/oncology" target="_blank">CenterWatch</a>. Never heard of of them? Check them out, talk to your oncologist...</span><br />
<br />
<b><span style="font-family: arial;"> </span>Drugs Approved in 2015</b><br />
<br />
<div style="-webkit-text-stroke-width: 0px; background-color: white; box-sizing: border-box; color: #333333; font-family: 'Open Sans', 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: 22.4px; margin: 0px 0px 11px; orphans: auto; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 1; word-spacing: 0px;">
<a href="https://www.centerwatch.com/drug-information/fda-approved-drugs/drug/100070/farydak-panobinostat" id="ctl00_BodyContent_DrugYearView_ctl00_DrugDetailLink" style="background-color: transparent; box-sizing: border-box; color: #0069ae; text-decoration: none;">Farydak (panobinostat)</a>; Novartis; For the treatment of multiple myeloma, Approved February 2015</div>
<div style="-webkit-text-stroke-width: 0px; background-color: white; box-sizing: border-box; color: #333333; font-family: 'Open Sans', 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: 22.4px; margin: 0px 0px 11px; orphans: auto; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 1; word-spacing: 0px;">
<a href="https://www.centerwatch.com/drug-information/fda-approved-drugs/drug/100068/ibrance-palbociclib" id="ctl00_BodyContent_DrugYearView_ctl01_DrugDetailLink" style="background-color: transparent; box-sizing: border-box; color: #0069ae; text-decoration: none;">Ibrance (palbociclib)</a>; Pfizer; For the treatment of ER-positive, HER2-negative breast cancer, Approved February 2015</div>
<div style="-webkit-text-stroke-width: 0px; background-color: white; box-sizing: border-box; color: #333333; font-family: 'Open Sans', 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: 22.4px; margin: 0px 0px 11px; orphans: auto; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 1; word-spacing: 0px;">
<a href="https://www.centerwatch.com/drug-information/fda-approved-drugs/drug/100069/lenvima-lenvatinib" id="ctl00_BodyContent_DrugYearView_ctl02_DrugDetailLink" style="background-color: transparent; box-sizing: border-box; color: #0069ae; text-decoration: none;">Lenvima (lenvatinib)</a>; Eisai; For the treatment of thyroid cancer, Approved February 2015</div>
<div style="-webkit-text-stroke-width: 0px; background-color: white; box-sizing: border-box; color: #333333; font-family: 'Open Sans', 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: 22.4px; margin: 0px 0px 11px; orphans: auto; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 1; word-spacing: 0px;">
<a href="https://www.centerwatch.com/drug-information/fda-approved-drugs/drug/100096/lonsurf-trifluridine-and-tipiracil" id="ctl00_BodyContent_DrugYearView_ctl03_DrugDetailLink" style="background-color: transparent; box-sizing: border-box; color: #0069ae; text-decoration: none;">Lonsurf (trifluridine and tipiracil)</a>; Taiho Oncology; For the treatment of metastatic colorectal cancer , Approved September 2015</div>
<div style="-webkit-text-stroke-width: 0px; background-color: white; box-sizing: border-box; color: #333333; font-family: 'Open Sans', 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: 22.4px; margin: 0px 0px 11px; orphans: auto; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 1; word-spacing: 0px;">
<a href="https://www.centerwatch.com/drug-information/fda-approved-drugs/drug/100088/odomzo-sonidegib" id="ctl00_BodyContent_DrugYearView_ctl04_DrugDetailLink" style="background-color: transparent; box-sizing: border-box; color: #0069ae; text-decoration: none;">Odomzo (sonidegib)</a>; Novartis; For the treatment of locally advanced basal cell carcinoma, July 2015</div>
<div style="-webkit-text-stroke-width: 0px; background-color: white; box-sizing: border-box; color: #333333; font-family: 'Open Sans', 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: 22.4px; margin: 0px 0px 11px; orphans: auto; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 1; word-spacing: 0px;">
<a href="https://www.centerwatch.com/drug-information/fda-approved-drugs/drug/100072/opdivo-nivolumab" id="ctl00_BodyContent_DrugYearView_ctl05_DrugDetailLink" style="background-color: transparent; box-sizing: border-box; color: #0069ae; text-decoration: none;">Opdivo (nivolumab)</a>; Bristol-Myers Squibb; For the treatment of metastatic squamous non-small cell lung cancer, Approved March 2015</div>
<div style="-webkit-text-stroke-width: 0px; background-color: white; box-sizing: border-box; color: #333333; font-family: 'Open Sans', 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: 22.4px; margin: 0px 0px 11px; orphans: auto; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 1; word-spacing: 0px;">
<a href="https://www.centerwatch.com/drug-information/fda-approved-drugs/drug/100074/unituxin-dinutuximab" id="ctl00_BodyContent_DrugYearView_ctl06_DrugDetailLink" style="background-color: transparent; box-sizing: border-box; color: #0069ae; text-decoration: none;">Unituxin (dinutuximab)</a>; United Therapeutics; For the treatment of pediatrics with high-risk neuroblastoma, Approved March 2015</div>
<div style="-webkit-text-stroke-width: 0px; background-color: white; box-sizing: border-box; color: #333333; font-family: 'Open Sans', 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: 22.4px; margin: 0px 0px 11px; orphans: auto; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 1; word-spacing: 0px;">
<a href="https://www.centerwatch.com/drug-information/fda-approved-drugs/drug/100093/varubi-rolapitant" id="ctl00_BodyContent_DrugYearView_ctl07_DrugDetailLink" style="background-color: transparent; box-sizing: border-box; color: #0069ae; text-decoration: none;">Varubi (rolapitant)</a>; Tesaro; For the prevention of delayed nausea and vomiting associated with chemotherapay, Approved September 2015</div>
<div style="-webkit-text-stroke-width: 0px; background-color: white; box-sizing: border-box; color: #333333; font-family: 'Open Sans', 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: 22.4px; margin: 0px 0px 11px; orphans: auto; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 1; word-spacing: 0px;">
<b>Drugs Approved in 2014</b></div>
<div style="-webkit-text-stroke-width: 0px; background-color: white; box-sizing: border-box; color: #333333; font-family: 'Open Sans', 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: 22.4px; margin: 0px 0px 11px; orphans: auto; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 1; word-spacing: 0px;">
<a href="https://www.centerwatch.com/drug-information/fda-approved-drugs/drug/100040/akynzeo-netupitant-and-palonosetron" id="ctl00_BodyContent_DrugYearView_ctl08_DrugDetailLink" style="background-color: transparent; box-sizing: border-box; color: #0069ae; text-decoration: none;">Akynzeo (netupitant and palonosetron)</a>; Helsinn; For the prevention of chemotherapy-induced nausea and vomiting, Approved October 2014</div>
<div style="-webkit-text-stroke-width: 0px; background-color: white; box-sizing: border-box; color: #333333; font-family: 'Open Sans', 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: 22.4px; margin: 0px 0px 11px; orphans: auto; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 1; word-spacing: 0px;">
<a href="https://www.centerwatch.com/drug-information/fda-approved-drugs/drug/100015/beleodaq-belinostat" id="ctl00_BodyContent_DrugYearView_ctl09_DrugDetailLink" style="background-color: transparent; box-sizing: border-box; color: #0069ae; text-decoration: none;">Beleodaq (belinostat)</a>; Spectrum Pharmaceuticals; For the treatment of relapsed or refractory peripheral T-cell lymphoma, Approved July 2014</div>
<div style="-webkit-text-stroke-width: 0px; background-color: white; box-sizing: border-box; color: #333333; font-family: 'Open Sans', 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: 22.4px; margin: 0px 0px 11px; orphans: auto; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 1; word-spacing: 0px;">
<a href="https://www.centerwatch.com/drug-information/fda-approved-drugs/drug/100046/blincyto-blinatumomab" id="ctl00_BodyContent_DrugYearView_ctl10_DrugDetailLink" style="background-color: transparent; box-sizing: border-box; color: #0069ae; text-decoration: none;">Blincyto (blinatumomab)</a>; Amgen; For the treatment of Philadelphia chromosome-negative relapsed /refractory B cell precursor acute lymphoblastic leukemia, Approved December 2014</div>
<div style="-webkit-text-stroke-width: 0px; background-color: white; box-sizing: border-box; color: #333333; font-family: 'Open Sans', 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: 22.4px; margin: 0px 0px 11px; orphans: auto; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 1; word-spacing: 0px;">
<a href="https://www.centerwatch.com/drug-information/fda-approved-drugs/drug/1320/cyramza-ramucirumab" id="ctl00_BodyContent_DrugYearView_ctl11_DrugDetailLink" style="background-color: transparent; box-sizing: border-box; color: #0069ae; text-decoration: none;">Cyramza (ramucirumab)</a>; Eli Lilly; For the treatment of gastric cancer, Approved April 2014</div>
<div style="-webkit-text-stroke-width: 0px; background-color: white; box-sizing: border-box; color: #333333; font-family: 'Open Sans', 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: 22.4px; margin: 0px 0px 11px; orphans: auto; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 1; word-spacing: 0px;">
<a href="https://www.centerwatch.com/drug-information/fda-approved-drugs/drug/1306/imbruvica-ibrutinib" id="ctl00_BodyContent_DrugYearView_ctl12_DrugDetailLink" style="background-color: transparent; box-sizing: border-box; color: #0069ae; text-decoration: none;">Imbruvica (ibrutinib)</a>; Pharmacyclics; For the treatment of chronic lymphocytic leukemia, Approved February 2014</div>
<div style="-webkit-text-stroke-width: 0px; background-color: white; box-sizing: border-box; color: #333333; font-family: 'Open Sans', 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: 22.4px; margin: 0px 0px 11px; orphans: auto; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 1; word-spacing: 0px;">
<a href="https://www.centerwatch.com/drug-information/fda-approved-drugs/drug/100034/keytruda-pembrolizumab" id="ctl00_BodyContent_DrugYearView_ctl13_DrugDetailLink" style="background-color: transparent; box-sizing: border-box; color: #0069ae; text-decoration: none;">Keytruda (pembrolizumab)</a>; Merck; For the treatment of unresectable or metastatic melanoma, Approved September 2014</div>
<div style="-webkit-text-stroke-width: 0px; background-color: white; box-sizing: border-box; color: #333333; font-family: 'Open Sans', 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: 22.4px; margin: 0px 0px 11px; orphans: auto; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 1; word-spacing: 0px;">
<a href="https://www.centerwatch.com/drug-information/fda-approved-drugs/drug/100049/lynparza-olaparib" id="ctl00_BodyContent_DrugYearView_ctl14_DrugDetailLink" style="background-color: transparent; box-sizing: border-box; color: #0069ae; text-decoration: none;">Lynparza (olaparib)</a>; AstraZeneca; For the treatment of previously treated BRCA mutated advanced ovarian cancer, Approved December 2014</div>
<div style="-webkit-text-stroke-width: 0px; background-color: white; box-sizing: border-box; color: #333333; font-family: 'Open Sans', 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: 22.4px; margin: 0px 0px 11px; orphans: auto; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 1; word-spacing: 0px;">
<a href="https://www.centerwatch.com/drug-information/fda-approved-drugs/drug/100051/opdivo-nivolumab" id="ctl00_BodyContent_DrugYearView_ctl15_DrugDetailLink" style="background-color: transparent; box-sizing: border-box; color: #0069ae; text-decoration: none;">Opdivo (nivolumab)</a>; Bristol-Myers Squibb; For the treatment of unresectable or metastatic melanoma, Approved December 2014</div>
<div style="-webkit-text-stroke-width: 0px; background-color: white; box-sizing: border-box; color: #333333; font-family: 'Open Sans', 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: 22.4px; margin: 0px 0px 11px; orphans: auto; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 1; word-spacing: 0px;">
<a href="https://www.centerwatch.com/drug-information/fda-approved-drugs/drug/100023/zydelig-idelalisib" id="ctl00_BodyContent_DrugYearView_ctl16_DrugDetailLink" style="background-color: transparent; box-sizing: border-box; color: #0069ae; text-decoration: none;">Zydelig (idelalisib)</a>; Gilead; For the treatment of relapsed CLL, follicular B-cell NHL and small lymphocytic lymphoma, Approved July 2014</div>
<div style="-webkit-text-stroke-width: 0px; background-color: white; box-sizing: border-box; color: #333333; font-family: 'Open Sans', 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: 22.4px; margin: 0px 0px 11px; orphans: auto; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 1; word-spacing: 0px;">
<a href="https://www.centerwatch.com/drug-information/fda-approved-drugs/drug/1322/zykadia-ceritinib" id="ctl00_BodyContent_DrugYearView_ctl17_DrugDetailLink" style="background-color: transparent; box-sizing: border-box; color: #0069ae; text-decoration: none;">Zykadia (ceritinib)</a>; Novartis; For the treatment of ALK+ metastatic non-small cell lung cancer, Approved April 2014</div>
<br />
<br />
<span style="font-family: arial;">Post Text Here
</span><br />
<span style="font-family: arial;">To put a smile on your face see <a href="http://www.cancer-clinical-trials.com/p/clinical-trials-in-cartoons.html">Larry's latest cartoon.</a></span><br />
<span style="font-family: arial;">To learn more about clinical trials, take a look at <a href="http://tinyurl.com/cancer-clinical-trials-book">our book.</a></span><br />
<span style="font-family: arial;">
<img height="75" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhAWYLVuUlu5Hq_Elg9pokI-Be5GFY8oe53iScn-8JSTfiAIDtmH6i7dl2al8n7es8vR4Jrb8RyXqdlAqt7geKEY8xbO2ZNy40uOc2nmpEwmUZCXPS2FRWvU4tlD8aTLWiV4kD8dX6S0Kg/s1600/WRITERS.jpg" width="100" /><br />
</span>
(c) 2012 Tom Beer and Larry AxmakerLarry Axmakerhttp://www.blogger.com/profile/03644176927295665033noreply@blogger.com0tag:blogger.com,1999:blog-1328313136038901535.post-92202779842005166352015-09-07T13:08:00.000-07:002015-09-07T13:08:34.291-07:00ASCO 2015 Prostate Cancer Updates from a Roundtable of ExpertsWhat's new and encouraging in prostate cancer treatment and research? This panel of experts, Dr. Bruce Montgomery,Moderator, Dr. Emanuel Antonarakis, Dr. Tomasz Beer, and Mr. Tom Kirk who is President and CEO of Us Too International, explain advances in research and treatment in 2015.<br />
Prostate cancer patients and cancer patients in general will find some hopeful news in this discussion.<br />
<br />
<br />
<iframe allowfullscreen="" frameborder="0" height="315" src="https://www.youtube.com/embed/t9ZqcUS2504" width="560"></iframe><br />
<br />
<br /><br />
<span style="font-family: arial;">Post Text Here
</span><br />
<span style="font-family: arial;">To put a smile on your face see <a href="http://www.cancer-clinical-trials.com/p/clinical-trials-in-cartoons.html">Larry's latest cartoon.</a></span><br />
<span style="font-family: arial;">To learn more about clinical trials, take a look at <a href="http://tinyurl.com/cancer-clinical-trials-book">our book.</a></span><br />
<span style="font-family: arial;">
<img height="75" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhAWYLVuUlu5Hq_Elg9pokI-Be5GFY8oe53iScn-8JSTfiAIDtmH6i7dl2al8n7es8vR4Jrb8RyXqdlAqt7geKEY8xbO2ZNy40uOc2nmpEwmUZCXPS2FRWvU4tlD8aTLWiV4kD8dX6S0Kg/s1600/WRITERS.jpg" width="100" /><br />
</span>
(c) 2012 Tom Beer and Larry AxmakerLarry Axmakerhttp://www.blogger.com/profile/03644176927295665033noreply@blogger.com0tag:blogger.com,1999:blog-1328313136038901535.post-89493088845876287322015-08-25T16:27:00.000-07:002015-08-25T16:30:37.954-07:00Cancer Clinical Trials and the Elderly—an Unlikely Combination<span style="font-family: arial;"><!--[if gte mso 9]><xml>
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<div class="MsoNormal">
<span style="font-family: arial;"><i style="mso-bidi-font-style: normal;">Did you know?</i></span></div>
<div class="MsoNormal">
<span style="font-family: arial;"><i style="mso-bidi-font-style: normal;"> </i>
</span></div>
<span style="font-family: arial;"></span><br />
<div class="MsoNormal">
<span style="font-family: arial;">Q<span style="mso-tab-count: 1;"> </span>What age
group is most likely to have Cancer?</span></div>
<span style="font-family: arial;">
</span>
<br />
<div class="MsoNormal">
<span style="font-family: arial;">A<span style="mso-tab-count: 1;"> </span>People older
than 65. They represent 13% of the population and more than 60% of all those
with cancer.</span></div>
<span style="font-family: arial;">
</span>
<div class="MsoNormal">
<span style="font-family: arial;"><br /></span></div>
<span style="font-family: arial;">
<div class="MsoNormal">
Q<span style="mso-tab-count: 1;"> </span>Who is most
likely to die of cancer?</div>
<div class="MsoNormal">
A<span style="mso-tab-count: 1;"> </span>Seniors.
About 80% of all cancer deaths occur in those older than 65.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Q<span style="mso-tab-count: 1;"> </span>What age
group is <i style="mso-bidi-font-style: normal;">least likely</i> to be represented
in cancer clinical trials?</div>
<div class="MsoNormal">
A<span style="mso-tab-count: 1;"> </span>Seniors. </div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Q<span style="mso-tab-count: 1;"> </span>Can seniors respond
to cancer medications in a different way than younger patients? (For example, having
more toxic side effects.)</div>
<div class="MsoNormal">
A<span style="mso-tab-count: 1;"> </span>Yes</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Q<span style="mso-tab-count: 1;"> </span>So, WHY are
seniors with cancer not included more in clinical trials?</div>
<div class="MsoNormal">
A<span style="mso-tab-count: 1;"> </span>It’s a long
story……</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Improving the <a href="http://www.ncbi.nlm.nih.gov/pubmed/26195697">research base for treating
older adults</a> with cancer was a focus of the 2015 ASCO conference. An expert
panel presented the problem and possible solutions. The <a href="http://jco.ascopubs.org/content/early/2015/07/14/JCO.2015.63.0319.long">Journal
of Clinical Oncology</a> reprinted the complete report and recommendations.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Factors such as meeting eligibility requirements can create
hurdles. Many older patients are limited in mobility, have numerous previous
treatment regimens, have a more limited predicted lifespan, and take multiple
medications (the average is more than 9 for patients over 65). Multiple
medications can interfere with trial medications. More than 80% of older
patients have a chronic condition (such as diabetes or arthritis) which can complicate
cancer treatment. </div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Doctors often do not even recommend older patients for
inclusion in clinical trials, although Doctor recommendation is the number one
predictor of older people choosing to participate in clinical trials.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Many oncologists, such as <a href="http://meetinglibrary.asco.org/content/11500127-156">Stuart Lichtman, MD</a>,
Memorial Sloan Kettering Cancer Center in NY, believes that seniors with cancer
are being short changed when it comes to cancer treatment because they are under-represented
in research. </div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
ASCO makes five recommendations to improve evidence generation
in the 65+ population:</div>
<div class="MsoNormal">
<br />
(1) Use clinical trials to improve the evidence base for
treating older adults (older than 65) with <span class="highlight">cancer</span>,</div>
<div class="MsoNormal">
<br />
(2) Leverage research designs and infrastructure for
generating evidence on older adults with <span class="highlight">cancer (change
trial requirements to fit older patients)</span>,</div>
<div class="MsoNormal">
<br />
(3) Increase US Food and Drug Administration authority to
incentivize and require research involving older adults with <span class="highlight">cancer</span>,</div>
<div class="MsoNormal">
<br />
(4) Increase clinicians' recruitment of older adults with <span class="highlight">cancer</span> to clinical trials (educate doctors to recommend
older patients for trials), and</div>
<div class="MsoNormal">
<br />
(5) Use journal policies to improve researchers' reporting
on the age distribution and health risk profiles of research participants.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Doctors currently have no choice but to use results from
clinical trials conducted with people in their 50s to treat people in their
80s.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Research results from clinical trials with older patients
could provide a better scientific basis for treating cancer in the elderly. As someone
who is elderly and has cancer, this author wholeheartedly supports these recommendations.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Click on the links in this article for a more comprehensive
discussion of this issue. </div>
</span><br />
<br />
<span style="font-family: arial;">Post Text Here
</span><br />
<span style="font-family: arial;">To put a smile on your face see <a href="http://www.cancer-clinical-trials.com/p/clinical-trials-in-cartoons.html">Larry's latest cartoon.</a></span><br />
<span style="font-family: arial;">To learn more about clinical trials, take a look at <a href="http://tinyurl.com/cancer-clinical-trials-book">our book.</a></span><br />
<span style="font-family: arial;">
<img height="75" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhAWYLVuUlu5Hq_Elg9pokI-Be5GFY8oe53iScn-8JSTfiAIDtmH6i7dl2al8n7es8vR4Jrb8RyXqdlAqt7geKEY8xbO2ZNy40uOc2nmpEwmUZCXPS2FRWvU4tlD8aTLWiV4kD8dX6S0Kg/s1600/WRITERS.jpg" width="100" /><br />
</span>
(c) 2012 Tom Beer and Larry AxmakerLarry Axmakerhttp://www.blogger.com/profile/03644176927295665033noreply@blogger.com0tag:blogger.com,1999:blog-1328313136038901535.post-67573335077805482522015-08-13T15:27:00.001-07:002015-08-17T07:12:30.218-07:00Prostate Cancer Research at OHSU--Interview<span style="font-family: arial;"> Tom's interview with Reggie Aqui at KGW Channel 8 in Portland.</span><br />
<br />
<br />
He covered prostate cancer basics, risk, types, and when to get tested.<br />
<br />
<div class="separator" style="clear: both; text-align: center;">
<iframe allowfullscreen='allowfullscreen' webkitallowfullscreen='webkitallowfullscreen' mozallowfullscreen='mozallowfullscreen' width='320' height='266' src='https://www.blogger.com/video.g?token=AD6v5dyNoRLvId4XmoVBwP_aLHu616ZxWrrygQivd_yhhpu8AorAB3fVuKIBnzOnQEJOPDT-JxJiIGDIV8z4Z9vP2A' class='b-hbp-video b-uploaded' frameborder='0'></iframe></div>
<br />
<br />
<span style="font-family: arial;">Post Text Here
</span><br />
<span style="font-family: arial;">To put a smile on your face see <a href="http://www.cancer-clinical-trials.com/p/clinical-trials-in-cartoons.html">Larry's latest cartoon.</a></span><br />
<span style="font-family: arial;">To learn more about clinical trials, take a look at <a href="http://tinyurl.com/cancer-clinical-trials-book">our book.</a></span><br />
<span style="font-family: arial;">
<img height="75" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhAWYLVuUlu5Hq_Elg9pokI-Be5GFY8oe53iScn-8JSTfiAIDtmH6i7dl2al8n7es8vR4Jrb8RyXqdlAqt7geKEY8xbO2ZNy40uOc2nmpEwmUZCXPS2FRWvU4tlD8aTLWiV4kD8dX6S0Kg/s1600/WRITERS.jpg" width="100" /><br />
</span>
(c) 2012 Tom Beer and Larry AxmakerLarry Axmakerhttp://www.blogger.com/profile/03644176927295665033noreply@blogger.com0tag:blogger.com,1999:blog-1328313136038901535.post-68675219386740191962015-08-04T09:07:00.001-07:002015-08-04T09:07:22.439-07:00Advances in Prostate Cancer Treatment this Past Year-ASCO 2015<span style="font-family: arial;"><!--[if gte mso 9]><xml>
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<span style="font-family: arial;">Dr. Tom Beer attended the 2015
ASCO (American Society of Clinical Oncology) Annual Meeting in Chicago. He
wrote a paper about some of the <span style="mso-spacerun: yes;"> </span>recent
discoveries and important advances in prostate cancer treatment. This is a
summary of that paper. You can find the original in the <a href="http://www.cancernetwork.com/oncology-journal/building-last-years-advances">Oncology
Journal.</a>
</span></div>
<span style="font-family: arial;"><div style="background: white; border-bottom: solid #DADADA 1.0pt; border: none; margin-left: .25in; margin-right: 0in; mso-border-bottom-alt: solid #DADADA .75pt; mso-element: para-border-div; padding: 0in 0in 9.0pt 0in;">
<ul>
<li><h1 style="background: white; border: none; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .25in; margin-right: 0in; margin-top: 22.5pt; mso-border-bottom-alt: solid #DADADA .75pt; mso-list: l0 level1 lfo1; mso-padding-alt: 0in 0in 9.0pt 0in; padding: 0in; text-indent: -.25in;">
<span style="font-family: Symbol; font-size: 12.0pt; font-weight: normal; mso-bidi-font-family: Symbol; mso-bidi-font-weight: bold; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;"><span style="font: 7.0pt "Times New Roman";"> </span></span></span><span style="font-size: 12.0pt; font-weight: normal; mso-bidi-font-weight: bold;">A trial called STAMPEDE (<span style="color: black;">Systemic
Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug
Efficacy) recruited men starting hormone therapy for high-risk, locally
advanced prostate cancer. </span>Multiple arms of the study are testing the
addition of various agents to standard hormonal therapy. The results of adding
docetaxel, zoledronic acid, or both were reported at ASCO. Nearly 3,000 men have
participated in the study. The use of docetaxel, with or without zoledronic
acid, significantly increased overall survival. The bottom line‑the use of
chemotherapy with hormonal therapy in patients with advanced metastatic
prostate cancer was supported.</span></h1>
</li>
<li><h1 style="background: white; border: none; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .25in; margin-right: 0in; margin-top: 22.5pt; mso-border-bottom-alt: solid #DADADA .75pt; mso-list: l0 level1 lfo1; mso-padding-alt: 0in 0in 9.0pt 0in; padding: 0in; text-indent: -.25in;">
<span style="font-family: Symbol; font-size: 12.0pt; font-weight: normal; mso-bidi-font-family: Symbol; mso-bidi-font-weight: bold; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;"><span style="font: 7.0pt "Times New Roman";"></span></span></span><span style="font-size: 12.0pt; font-weight: normal; mso-bidi-font-weight: bold;">In Radiation Therapy Oncology Group study 0521, the
early use of chemotherapy was also evaluated, along with radiation and hormonal
therapy, in high-risk localized disease.[2] Six hundred twelve patients with
localized prostate cancer and features consistent with a high risk of relapse
were treated with radiation therapy and 2 years of hormonal therapy with or
without 6 cycles of docetaxel. The addition of chemotherapy resulted in an
improvement in the 4-year overall survival rate and improvement in 5-year
disease free survival. These results support earlier trials which found that
using chemotherapy in the initial management of metastatic prostate cancer
increased survival time. Additional follow-up is necessary before this becomes
standard treatment.</span></h1>
</li>
<li><h1 style="background: white; border: none; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .25in; margin-right: 0in; margin-top: 22.5pt; mso-border-bottom-alt: solid #DADADA .75pt; mso-list: l0 level1 lfo1; mso-padding-alt: 0in 0in 9.0pt 0in; padding: 0in; text-indent: -.25in;">
<span style="color: black; font-family: Symbol; font-size: 12.0pt; font-weight: normal; mso-bidi-font-family: Symbol; mso-bidi-font-weight: bold; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;"><span style="font: 7.0pt "Times New Roman";"></span></span></span><span style="color: black; font-size: 12.0pt; font-weight: normal; mso-bidi-font-weight: bold;">A French study, the GETUG-AFU 16
trial, used radiation in men with a PSA rise after a prostatectomy. A six month
regimen of hormonal therapy was added for some of the patients.
Progression-free survival was significantly improved in those patients
receiving the combination therapy. </span></h1>
</li>
<li><h1 style="background: white; border: none; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .25in; margin-right: 0in; margin-top: 22.5pt; mso-border-bottom-alt: solid #DADADA .75pt; mso-list: l0 level1 lfo1; mso-padding-alt: 0in 0in 9.0pt 0in; padding: 0in; text-indent: -.25in;">
<span style="color: black; font-family: Symbol; font-size: 12.0pt; font-weight: normal; mso-bidi-font-family: Symbol; mso-bidi-font-weight: bold; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;"><span style="font: 7.0pt "Times New Roman";"></span></span></span><span style="color: black; font-size: 12.0pt; font-weight: normal; mso-bidi-font-weight: bold;">How soon to begin hormonal
therapy in men with rising PSA levels was the focus of another study. Men were
randomly assigned to a group that started hormonal therapy in two years or four
years. The overall survival rate was significantly higher in the men who began
therapy at two years. A concern in using hormonal therapy is toxic side
effects. Early study results suggest earlier use of hormonal therapy may save
lives in spite of side effects. Larger, more definitive studies are needed to
test these results. </span></h1>
</li>
<li><h1 style="background: white; border: none; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .25in; margin-right: 0in; margin-top: 22.5pt; mso-border-bottom-alt: solid #DADADA .75pt; mso-list: l0 level1 lfo1; mso-padding-alt: 0in 0in 9.0pt 0in; padding: 0in; text-indent: -.25in;">
<span style="font-family: Symbol; font-size: 12.0pt; font-weight: normal; mso-bidi-font-family: Symbol; mso-bidi-font-weight: bold; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;"><span style="font: 7.0pt "Times New Roman";"> </span></span></span><span style="color: black; font-size: 12.0pt; font-weight: normal; mso-bidi-font-weight: bold;">A comparison of the use of
intermittent hormonal therapy versus continual hormone therapy was the focus of
a study conducted by the Southwest Oncology Group (SWOG). One group of older
men received continual ongoing hormonal therapy and the other group i</span><span style="font-size: 12.0pt; font-weight: normal; mso-bidi-font-weight: bold;">ntermittent
treatment. Early results suggest the intermittent treatment group had more
medical events over the time of the study than those on continual hormonal
therapy. </span></h1>
</li>
<li><h1 style="background: white; border: none; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .25in; margin-right: 0in; margin-top: 22.5pt; mso-border-bottom-alt: solid #DADADA .75pt; mso-list: l0 level1 lfo1; mso-padding-alt: 0in 0in 9.0pt 0in; padding: 0in; text-indent: -.25in;">
<span style="font-family: Symbol; font-size: 12.0pt; font-weight: normal; mso-bidi-font-family: Symbol; mso-bidi-font-weight: bold; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;"><span style="font: 7.0pt "Times New Roman";"></span></span></span><span style="font-size: 12.0pt; font-weight: normal; mso-bidi-font-weight: bold;">Hormonal therapy is routinely combined with
radiation for the treatment of high-risk and most intermediate-risk patients.
But in intermediate-risk patients, the combination is not as well studied and
questions about the need for hormonal therapy have been raised. A randomized
trial that involved 600 participants showed that biochemical and disease-free
survival with 6 months of hormonal therapy plus radiation were superior even to
results with dose-escalated radiation, providing support for the widely
practiced approach of combining these two treatment modalities. </span></h1>
</li>
</ul>
</div>
</span><br />
<span style="font-family: arial;">Post Text Here
</span><br />
<span style="font-family: arial;">To put a smile on your face see <a href="http://www.cancer-clinical-trials.com/p/clinical-trials-in-cartoons.html">Larry's latest cartoon.</a></span><br />
<span style="font-family: arial;">To learn more about clinical trials, take a look at <a href="http://tinyurl.com/cancer-clinical-trials-book">our book.</a></span><br />
<span style="font-family: arial;">
<img height="75" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhAWYLVuUlu5Hq_Elg9pokI-Be5GFY8oe53iScn-8JSTfiAIDtmH6i7dl2al8n7es8vR4Jrb8RyXqdlAqt7geKEY8xbO2ZNy40uOc2nmpEwmUZCXPS2FRWvU4tlD8aTLWiV4kD8dX6S0Kg/s1600/WRITERS.jpg" width="100" /><br />
</span>
(c) 2012 Tom Beer and Larry AxmakerLarry Axmakerhttp://www.blogger.com/profile/03644176927295665033noreply@blogger.com0tag:blogger.com,1999:blog-1328313136038901535.post-53078886448849479932015-07-19T15:33:00.000-07:002015-07-19T15:33:31.857-07:00A Blog is a Blog is a Blog…<span style="font-family: arial;"><!--[if gte mso 9]><xml>
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<span style="font-family: arial;"><b>Or is it??? </b></span></div>
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<br /></div>
<span style="font-family: arial;"><div class="MsoNormal">
This blog was started in 2012 just after our book, Cancer
Clinical Trials, was published. Our goal was to provide information about
clinical trials, new meds, FDA approvals, how to participate in clinical
trials, and other information related to cancer clinical trials. We have tried
to be positive, encouraging, and occasionally make you smile. This reflects our
outlook on life. Our blog entries are primarily aimed at those with cancer,
those thinking about participating in a clinical trial, and the family and
friends of those with cancer.</div>
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<br /></div>
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Some have questioned our inclusion of humor. Is there a
place for humor in this serious subject? Cancer is not funny, of course, but a
positive attitude, sense of humor, and ability to laugh may make life a little
easier. This author, Larry, has been living with prostate cancer for 12 years.
Being able to laugh at myself, the idiosyncrasies of the medical world, high
drug prices, endless forms to fill out, strange side effects, etc. has made my
quality of life a little better. We have been pleased to receive positive
feedback from many blog followers.</div>
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<br /></div>
<div class="MsoNormal">
There are literally millions and millions of blogs out there
somewhere. There is something for everybody. They run the range of the very
scientific, factual and useful information of all sorts, entertainment, political
(not necessarily factual), personal diaries, pictures of cute kittens, and
probably more than a few X-rated and nefarious ones. The odds are good that you
or someone you know has a blog.</div>
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<br /></div>
<div class="MsoNormal">
Cancer is the topic of a lot of these blogs. Many are
dedicated to specific cancers (breast, lung, prostate, skin, and on and on).
Then there are the personal information and experience blogs which are not always factual (we hope ours is), and all are
infinitely varied. We hope you will follow our blog, but you may find others
you prefer. The advantage of having so many choices is that you’ll surely find
just what you’re looking for. </div>
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<br /></div>
<div class="MsoNormal">
We will continue to provide cutting edge cancer and clinical
trial information, a few personal anecdotes, and a bit of humor‑‑often in the
form of G-rated cartoons. </div>
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<br /></div>
Post Text Here
</span><br />
<span style="font-family: arial;">To put a smile on your face see <a href="http://www.cancer-clinical-trials.com/p/clinical-trials-in-cartoons.html">Larry's latest cartoon.</a></span><br />
<span style="font-family: arial;">To learn more about clinical trials, take a look at <a href="http://tinyurl.com/cancer-clinical-trials-book">our book.</a></span><br />
<span style="font-family: arial;">
<img height="75" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhAWYLVuUlu5Hq_Elg9pokI-Be5GFY8oe53iScn-8JSTfiAIDtmH6i7dl2al8n7es8vR4Jrb8RyXqdlAqt7geKEY8xbO2ZNy40uOc2nmpEwmUZCXPS2FRWvU4tlD8aTLWiV4kD8dX6S0Kg/s1600/WRITERS.jpg" width="100" /><br />
</span>
(c) 2012 Tom Beer and Larry AxmakerLarry Axmakerhttp://www.blogger.com/profile/03644176927295665033noreply@blogger.com0tag:blogger.com,1999:blog-1328313136038901535.post-64526751658551399822015-06-29T07:33:00.002-07:002015-06-29T07:33:31.065-07:00A BILLION dollars buys a lot of research<span style="font-family: arial;">OHSU Press release:</span><br />
<h1>
OHSU sets fundraising record by meeting $1 billion challenge from Nike co-founder and wife</h1>
<div class="dp_block">
<b>06/25/15 Portland, Ore.</b><br />
<i>$1 billion will create first large-scale program to overhaul early detection of lethal cancers<br />Fast-track recruitment of 250-300 scientists set to launch</i><br />
<br />
Oregon Health & Science University today announced it met Nike
co-founder Phil Knight and his wife Penny’s $1 billion challenge by
raising $500 million in less than two years to earn the Knights’
matching gift and set a fundraising record.<br />
<br />
The $1 billion will support the first large-scale program dedicated
to early detection of lethal cancers — one of the biggest unmet needs in
cancer care today.<br />
<br />
“While cancer treatment has evolved to become more precise and less
toxic, the tests and tools used for cancer detection have not changed in
decades. Without better, earlier detection, and a full understanding of
cancer’s origins in the body, the promise of precision cancer medicine
cannot be realized,” said <b>Brian Druker, M.D.</b>, director of the OHSU Knight Cancer Institute.<br />
<br />
Meeting the Knights’ $500 million fundraising challenge marks the
largest documented challenge pledge to succeed, according to researchers
with the Indiana University Lilly Family School of Philanthropy.<br />
<br />
“Penny and I have total confidence in Brian Druker and the entire
OHSU Knight Cancer Institute team to put a stop to a disease that
touches each of our lives,” Phil Knight said. “These last 22 months have
shown what is possible when people of vision focus on a single goal. We
are more convinced than ever that cancer will meet its match at OHSU,
and we are proud to play a role in this history in the making.”<br />
<br />
With $1 billion in new funding, the OHSU Knight Cancer Institute will
begin fast-track recruitment of about 25 of the world’s top
researchers. These recruits will, in turn, hire an additional 225 to 275
scientists and physicians, forming a team focused on the detection of
cancer, including the early biological changes in the body that signal a
lethal cancer is beginning to develop. Catching the disease in these
very early stages will unleash the full potential of precision cancer
medicine. It will make it possible to detect cancer when it first starts
and treat it when it’s most curable, with the fewest side effects and
at the lowest cost.<br />
<br />
These scientists will be given substantial financial support, so they
can focus on discovery instead of spending time securing grants. With
this expansion, OHSU will also move forward with construction of two
buildings ― a state-of-the-art cancer research facility designed from
the ground up to support a new model of combining scientific disciplines
to speed progress and new cancer care clinics for expanded clinical
trials that will translate the scientific discoveries made by the team
into next-generation detection tests, tools and treatments.<br />
<br />
“This is a historic milestone for cancer research, for Oregon and for our institution,” said OHSU President <b>Joe Robertson, M.D., M.B.A.</b>
“The support we have received to achieve our ambitious goal ― putting
an end to cancer as we know it ― has been nothing short of stunning. We
are deeply grateful to the state of Oregon for its leadership and
investment at the early stages of our campaign as well as to the
thousands of individuals, companies and foundations who joined us along
the way.”<br />
In the past few weeks, more than $20 million in donations came in to
support the campaign, including significant gifts from Cambia Health
Foundation; Pat and Stephanie Kilkenny of San Diego, California; Mark
Wolfson and Jasper Ridge Partners; Intel Corporation; Wayne D. Kuni and
Joan E. Kuni Foundation; the Blumenfeld family of New York City; the
Wendt family of Klamath Falls, Oregon; and Consumer Cellular.<br />
<ul>
<li>The largest gift received since the campaign launched in 2013 was
from the state of Oregon, which invested $200 million for the needed
research and clinical facilities.</li>
<li>The largest gift from an individual ―$100 million — came from Columbia Sportswear Chairman Gert Boyle.</li>
<li>In all, more than 10,000 donors participated and, of these, more than half were first-time donors to OHSU.</li>
<li>Donations were received from every state in the nation and five countries.</li>
</ul>
“Our work is just beginning,” added <b>L. Keith Todd</b>,
president of the OHSU Foundation. “The Knight Cancer Challenge created
an unstoppable movement against cancer. We will continue our efforts to
ensure OHSU has all the resources it needs to achieve its vision. Our
sense of urgency will not recede until we have fully delivered on the
promise of stopping this life-threatening disease.”<br />
<br />
The Knights made their challenge pledge in September 2013 after being
inspired by the OHSU Knight Cancer Institute’s goal to revolutionize
how cancer is detected. The challenge pledge follows their $100 million
gift to OHSU in 2008 to support Druker’s work, which helped pioneer the
field of precision medicine.<br />
<br />
Druker conducted the breakthrough research that led to the
development of Gleevec® for chronic myeloid leukemia. This once-a-day
cancer pill proved it was possible to kill cancer cells without harming
healthy cells. Since he first proved this new type of treatment was
possible, many other precision treatments have been developed ― making
less toxic, tailored cancer treatment a reality for many patients and
launching the field of personalized or precision medicine.<br />
<br />
“Today too many patients die or have to suffer through debilitating
treatments because their disease is caught too late. Too few physicians
and scientists are focused on this problem in a meaningful way and we
are committed to filling that gap,” Druker said. “We are thankful to
everyone who is making this goal a reality.”<br />
<h2>
About the Knight Cancer Institute</h2>
The <a href="http://www.ohsu.edu/xd/health/services/cancer/" id="http://www.ohsu.edu/xd/health/services/cancer/|" target="_blank">Knight Cancer Institute</a>
at Oregon Health & Science University is a pioneer in the field of
personalized cancer medicine. The institute's director, Brian Druker,
M.D., helped prove it was possible to shut down cells that enable cancer
to grow without harming healthy cells. This breakthrough has made
once-fatal forms of the disease manageable and ushered in a new
generation of targeted cancer therapies. The OHSU Knight Cancer
Institute is the only National Cancer Institute-designated Cancer Center
between Sacramento and Seattle – an honor earned only by the nation's
top cancer centers. It offers the latest treatments and technologies as
well as hundreds of research studies and clinical trials.<br />
<h2>
About OHSU</h2>
<a href="http://www.ohsu.edu/xd/" target="_blank">Oregon Health & Science University</a>
is a nationally prominent research university and Oregon’s only public
academic health center. It serves patients throughout the region with a
Level 1 trauma center and nationally recognized Doernbecher Children’s
Hospital. OHSU operates dental, medical, nursing and pharmacy schools
that rank high both in research funding and in meeting the university’s
social mission. OHSU’s Knight Cancer Institute helped pioneer
personalized medicine through a discovery that identified how to shut
down cells that enable cancer to grow without harming healthy ones. OHSU
Brain Institute scientists are nationally recognized for discoveries
that have led to a better understanding of Alzheimer’s disease and new
treatments for Parkinson’s disease, multiple sclerosis and stroke.
OHSU’s Casey Eye Institute is a global leader in ophthalmic imaging, and
in clinical trials related to eye disease.</div>
<br />
<br />
<span style="font-family: arial;">Post Text Here
</span><br />
<span style="font-family: arial;">To put a smile on your face see <a href="http://www.cancer-clinical-trials.com/p/clinical-trials-in-cartoons.html">Larry's latest cartoon.</a></span><br />
<span style="font-family: arial;">To learn more about clinical trials, take a look at <a href="http://tinyurl.com/cancer-clinical-trials-book">our book.</a></span><br />
<span style="font-family: arial;">
<img height="75" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhAWYLVuUlu5Hq_Elg9pokI-Be5GFY8oe53iScn-8JSTfiAIDtmH6i7dl2al8n7es8vR4Jrb8RyXqdlAqt7geKEY8xbO2ZNy40uOc2nmpEwmUZCXPS2FRWvU4tlD8aTLWiV4kD8dX6S0Kg/s1600/WRITERS.jpg" width="100" /><br />
</span>
(c) 2012 Tom Beer and Larry AxmakerLarry Axmakerhttp://www.blogger.com/profile/03644176927295665033noreply@blogger.com0tag:blogger.com,1999:blog-1328313136038901535.post-32157110622674743312015-06-20T06:58:00.003-07:002015-06-20T06:59:49.092-07:00NCI-MATCH Trials…Something NewIn a recent press release, the <a href="http://www.cancer.gov/news-events/press-releases/2015/nci-match">National
Cancer Institute</a> outlined a new cancer clinical trial program, focused on
linking targeted cancer drugs to gene abnormalities. MATCH stands for Molecular
Analysis for Therapy Choice.<br />
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<i style="mso-bidi-font-style: normal;">The trial seeks to
determine whether targeted therapies for people whose tumors have specific gene
mutations will be effective <span style="background: #FFFFFB; color: #2e2e2e;">regardless
of their cancer type. NCI-MATCH will incorporate more than 20 different study
drugs or drug combinations, each targeting a specific gene mutation, in order
to match each patient in the trial with a therapy that targets a molecular
abnormality in their tumor. </span></i></div>
<div class="MsoNormal">
<i style="mso-bidi-font-style: normal;"><span style="background: #FFFFFB; color: #2e2e2e;">NCI-MATCH is a phase II trial with
numerous small substudies (arms) for each treatment being investigated. It will
open with approximately 10 substudies, moving to 20 or more within months.<span class="apple-converted-space"> </span></span></i></div>
<div class="MsoNormal">
<br /></div>
<div style="background: #FFFFFB; line-height: 18.0pt; margin-bottom: 6.0pt; margin-left: 0in; margin-right: 0in; margin-top: 6.0pt; vertical-align: baseline;">
<i style="mso-bidi-font-style: normal;"><span style="color: #2e2e2e;">The NCI-MATCH
trial has two enrollment steps. Each patient will initially enroll for
screening in which samples of their tumor will be removed (biopsied). The
samples will undergo DNA sequencing to detect genetic abnormalities that may be
driving tumor growth and might be targeted by one of a wide range of drugs
being studied. If a molecular abnormality is detected for which there is a
specific substudy available, to be accepted in NCI-MATCH patients will be
further evaluated to determine if they meet the specific eligibility
requirements within that arm. Once enrolled, patients will be treated with the
targeted drug regimen for as long as their tumor shrinks or remains stable.
Overall, trial investigators plan to screen about 3,000 patients during the
full course of the NCI-MATCH trial to enroll about 1,000 patients in the various
treatment arms.</span></i></div>
<div style="background: #FFFFFB; line-height: 18.0pt; margin-bottom: 6.0pt; margin-left: 0in; margin-right: 0in; margin-top: 6.0pt; vertical-align: baseline;">
<br /></div>
<div style="background: #FFFFFB; line-height: 18.0pt; margin-bottom: 6.0pt; margin-left: 0in; margin-right: 0in; margin-top: 6.0pt; vertical-align: baseline;">
<i style="mso-bidi-font-style: normal;"><span style="color: #2e2e2e;">Adults 18 years
of age and older with solid tumors or lymphomas that have advanced following at
least one line of standard systemic therapy, or with tumors for which there is
no standard treatment, will be eligible. Each arm of the trial will enroll up
to 35 patients. The trial’s design calls for at least a quarter of the
1,000-patients enrolled to involve people with rare types of cancer.<span class="apple-converted-space"> </span></span></i></div>
<div style="background: #FFFFFB; line-height: 18.0pt; margin-bottom: 6.0pt; margin-left: 0in; margin-right: 0in; margin-top: 6.0pt; vertical-align: baseline;">
<br /></div>
<div class="MsoNormal">
For several years now there has been much discussion of
using targeted therapies to treat cancer—this will be the first big study to
actually do it.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<i style="mso-bidi-font-style: normal;"><span style="background: #FFFFFB; color: #2e2e2e;">“NCI-MATCH is a unique,
ground-breaking trial,” said Doug Lowy, M.D., NCI acting director. "It is
the first study in oncology that incorporates all of the tenets of precision
medicine. There are no other cancer clinical trials of this size and scope that
truly bring the promise of targeted treatment to patients whose cancers have
specific genetic abnormalities. It holds the potential to transform cancer
care.”</span></i></div>
<div class="MsoNormal">
<i style="mso-bidi-font-style: normal;"><span style="background: #FFFFFB; color: #2e2e2e;">Since many gene mutations in tumors
are infrequent or unique, screening for individual mutations is not
cost-effective or efficient in clinical trials. Instead, NCI-MATCH will use
advanced gene sequencing techniques to screen for many molecular abnormalities
at once. Large numbers of patient tumors will need to be screened because most
gene mutations occur in 10 percent or less of cancer patients. Most patients
are expected to have one, or at most two, treatable mutations in their tumors.
By having multiple treatments available for these genetic abnormalities in a
single clinical trial, several different study drugs or drug combinations can
be evaluated simultaneously.</span></i></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<i style="mso-bidi-font-style: normal;"><span style="background: #FFFFFB; color: #2e2e2e;">The cancer treatment drugs being used
in NCI-MATCH include both U.S. Food and Drug Administration approved drugs as
well as investigational agents that are being contributed by a number of
pharmaceutical companies. Most of the arms in the trial will incorporate
single-agent drugs that are either commercially available or are still being
tested in clinical trials. However, a few arms will contain combinations of
drugs for which there are enough safety data and evidence that they might be
active against a particular genetic abnormality.</span></i></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Screening has not started (starts in July 2015) and there is
no specific timeline. Participants will continue to take the trial drugs until
their cancer no longer responds to the medications. This approach may be the
template for future targeted treatments. Specific drugs for specific gene mutations is a step forward. Watch for results—sometime soon, I
hope. </div>
<br />
<br />
<span style="font-family: arial;">Post Text Here
</span><br />
<span style="font-family: arial;">To put a smile on your face see <a href="http://www.cancer-clinical-trials.com/p/clinical-trials-in-cartoons.html">Larry's latest cartoon.</a></span><br />
<span style="font-family: arial;">To learn more about clinical trials, take a look at <a href="http://tinyurl.com/cancer-clinical-trials-book">our book.</a></span><br />
<span style="font-family: arial;">
<img height="75" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhAWYLVuUlu5Hq_Elg9pokI-Be5GFY8oe53iScn-8JSTfiAIDtmH6i7dl2al8n7es8vR4Jrb8RyXqdlAqt7geKEY8xbO2ZNy40uOc2nmpEwmUZCXPS2FRWvU4tlD8aTLWiV4kD8dX6S0Kg/s1600/WRITERS.jpg" width="100" /><br />
</span>
(c) 2012 Tom Beer and Larry AxmakerLarry Axmakerhttp://www.blogger.com/profile/03644176927295665033noreply@blogger.com0tag:blogger.com,1999:blog-1328313136038901535.post-9584546497093272172015-05-26T12:05:00.001-07:002015-05-26T12:05:11.597-07:00Clinical Trials--Why Bother?<b><span style="font-family: arial;">Editorial Comment</span></b><br />
<br />
<span style="font-family: arial;">Most clinical trials DO NOT result in a successful drug or treatment being approved by the FDA. Most clinical trials DO NOT provide a benefit for most participants. So why should anybody participate in a clinical trial?</span><br />
<span style="font-family: arial;"><br /></span>
<span style="font-family: arial;">I have participated in several clinical trials. None of them cured me or slowed the progression of my cancer. None of them did any harm, either (so far). I would participate in future clinical trials if they were relevant to my cancer, if I trusted the researchers, and I didn't have to travel too far too often.</span><br />
<br />
<span style="font-family: arial;">Clinical Trials are good at finding out what DOES NOT work. That is an important step. It allows researchers to try something else, go a new direction, or get back to the laboratory and start over. </span><br />
<span style="font-family: arial;"><br /></span>
<span style="font-family: arial;">I personally hope that there are many more cancer clinical trials in the future. If only one in ten trials is successful, then we need many <i>tens</i> of trials. Every once in a while there is a major breakthrough usually for one type of one cancer. Mine might be next!</span><br />
<span style="font-family: arial;"><br /></span>
<b><span style="font-family: arial;">Bottom Line</span></b><br />
<span style="font-family: arial;">Clinical Trials thrive on numbers. Volunteering to participate helps you, me, everyone else with cancer, and all those who do not yet have cancer. Many trials never get started because not enough of us participate. One of them could have been the breakthrough that would help me--or maybe you.</span><br />
<span style="font-family: arial;"><br /></span>
<span style="font-family: arial;">Larry Axmaker--12 year cancer survivor</span><br />
<br />
<span style="font-family: arial;">Post Text Here
</span><br />
<span style="font-family: arial;">To put a smile on your face see <a href="http://www.cancer-clinical-trials.com/p/clinical-trials-in-cartoons.html">Larry's latest cartoon.</a></span><br />
<span style="font-family: arial;">To learn more about clinical trials, take a look at <a href="http://tinyurl.com/cancer-clinical-trials-book">our book.</a></span><br />
<span style="font-family: arial;">
<img height="75" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhAWYLVuUlu5Hq_Elg9pokI-Be5GFY8oe53iScn-8JSTfiAIDtmH6i7dl2al8n7es8vR4Jrb8RyXqdlAqt7geKEY8xbO2ZNy40uOc2nmpEwmUZCXPS2FRWvU4tlD8aTLWiV4kD8dX6S0Kg/s1600/WRITERS.jpg" width="100" /><br />
</span>
(c) 2012 Tom Beer and Larry AxmakerLarry Axmakerhttp://www.blogger.com/profile/03644176927295665033noreply@blogger.com1tag:blogger.com,1999:blog-1328313136038901535.post-49275960813670848902015-04-21T09:38:00.002-07:002015-04-21T09:38:27.262-07:00Clinical Trial stopped early for Breast Cancer Drug Ibrance®<span style="font-family: arial;"><!--[if gte mso 9]><xml>
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<span style="font-family: arial;"><i style="mso-bidi-font-style: normal;"><span style="border: none windowtext 1.0pt; color: #444444; font-family: "Helvetica","sans-serif"; font-size: 8.0pt; line-height: 115%; mso-border-alt: none windowtext 0in; padding: 0in;"></span></i><b style="mso-bidi-font-weight: normal;">Another clinical
trial success story</b></span></div>
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<span style="font-family: arial;"><b style="mso-bidi-font-weight: normal;"> </b>
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<span style="font-family: arial;"><div class="MsoNormal">
Ibrance<i style="mso-bidi-font-style: normal;"><span style="border: none windowtext 1.0pt; color: #444444; font-family: "Helvetica","sans-serif"; font-size: 8.0pt; line-height: 115%; mso-border-alt: none windowtext 0in; padding: 0in;">®</span></i> (palbociclib) trials were halted early by its creator
<a href="http://www.pfizer.com/news/press-release/press-release-detail/pfizer_announces_paloma_3_trial_for_ibrance_palbociclib_stopped_early_due_to_efficacy_seen_in_patients_with_hr_her2_metastatic_breast_cancer_whose_disease_has_progressed_following_endocrine_therapy">Pfizer</a>
when it met its primary endpoint—a statistically significant improvement in
progression-free survival in postmenopausal women with HR+, HER2 metastatic
breast cancer. This has been a particularly difficult cancer to treat.</div>
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<br /></div>
<div class="MsoNormal">
Pfizer announced in an April, 15, 2015 press release:</div>
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<i style="mso-bidi-font-style: normal;"><span style="background: #FEFEFE; color: #444444; font-family: "Helvetica","sans-serif"; font-size: 10.5pt; line-height: 115%;">IBRANCE was approved by the U.S. Food and
Drug Administration (FDA) in February 2015 as a first-line treatment for women
with advanced or metastatic estrogen receptor positive, human epidermal growth
factor receptor 2 negative (ER+/HER2-) breast cancer. IBRANCE</span></i><i style="mso-bidi-font-style: normal;"><span style="border: none windowtext 1.0pt; color: #444444; font-family: "Helvetica","sans-serif"; font-size: 8.0pt; line-height: 115%; mso-border-alt: none windowtext 0in; padding: 0in;">® </span></i><i style="mso-bidi-font-style: normal;"><span style="background: #FEFEFE; color: #444444; font-family: "Helvetica","sans-serif"; font-size: 10.5pt; line-height: 115%;">(palbociclib),
in combination with letrozole, is indicated for the treatment of postmenopausal
women with ER+/HER2- advanced breast cancer as initial endocrine-based therapy
for their metastatic disease</span></i><i style="mso-bidi-font-style: normal;"><span style="border: none windowtext 1.0pt; color: #444444; font-family: "Helvetica","sans-serif"; font-size: 8.0pt; line-height: 115%; mso-border-alt: none windowtext 0in; padding: 0in;">. </span></i><i style="mso-bidi-font-style: normal;"><span style="background: #FEFEFE; color: #444444; font-family: "Helvetica","sans-serif"; font-size: 10.5pt; line-height: 115%;">This indication is approved under accelerated
approval based on PFS. Continued approval for this indication may be contingent
upon verification and description of clinical benefit in a confirmatory trial.
The confirmatory Phase 3 trial, PALOMA-2, is fully enrolled. IBRANCE is not
approved for the use being investigated in PALOMA-3 or for any indication in
any market outside the U.S.</span></i></div>
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<br /></div>
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The trials were conducted in more than 150 global sites. Although
the FDA has approved Ibrance<i style="mso-bidi-font-style: normal;"><span style="border: none windowtext 1.0pt; color: #444444; font-family: "Helvetica","sans-serif"; font-size: 8.0pt; line-height: 115%; mso-border-alt: none windowtext 0in; padding: 0in;">®</span></i>, the Phase III studies are ongoing. The combination
of Ibrance<i style="mso-bidi-font-style: normal;"><span style="border: none windowtext 1.0pt; color: #444444; font-family: "Helvetica","sans-serif"; font-size: 8.0pt; line-height: 115%; mso-border-alt: none windowtext 0in; padding: 0in;">®</span></i>
plus letrozole extended progression-free survival by about 50% (from 10.2
months with letrozole alone to 20.2 months with the combination) in the Phase
II part of the study.</div>
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<br /></div>
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If you or somebody you know might benefit from this drug,
talk to your doctors.</div>
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<br /></div>
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The <a href="http://www.cancer.org/research/cancerfactsstatistics/breast-cancer-facts-figures">American
Cancer Society</a> (ACS) estimates that more than 230,000 American women will
be diagnosed the breast cancer and more than 39,000 women will die from breast
cancer this year. This new drug is expected to prolong many lives.</div>
<div class="MsoNormal">
<br /></div>
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This drug is one of the new generation of highly effective
and very expensive drugs. The projected cost of Ibrance<i style="mso-bidi-font-style: normal;"><span style="border: none windowtext 1.0pt; color: #444444; font-family: "Helvetica","sans-serif"; font-size: 8.0pt; line-height: 115%; mso-border-alt: none windowtext 0in; padding: 0in;">®</span></i> will be $9,850 a month. This is not out of line with
other recently approved cancer treatment drugs.</div>
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<br /></div>
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For more information on clinical trials, what they are,
where they are, and if you might qualify to participate, go to the <a href="https://clinicaltrials.gov/">National Institutes of Health</a> clinical
trials site.</div>
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<br /></div>
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</span><br />
<span style="font-family: arial;">Post Text Here
</span><br />
<span style="font-family: arial;">To put a smile on your face see <a href="http://www.cancer-clinical-trials.com/p/clinical-trials-in-cartoons.html">Larry's latest cartoon.</a></span><br />
<span style="font-family: arial;">To learn more about clinical trials, take a look at <a href="http://tinyurl.com/cancer-clinical-trials-book">our book.</a></span><br />
<span style="font-family: arial;">
<img src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhAWYLVuUlu5Hq_Elg9pokI-Be5GFY8oe53iScn-8JSTfiAIDtmH6i7dl2al8n7es8vR4Jrb8RyXqdlAqt7geKEY8xbO2ZNy40uOc2nmpEwmUZCXPS2FRWvU4tlD8aTLWiV4kD8dX6S0Kg/s1600/WRITERS.jpg" height="75" width="100" /><br />
</span>
(c) 2012 Tom Beer and Larry AxmakerLarry Axmakerhttp://www.blogger.com/profile/03644176927295665033noreply@blogger.com0tag:blogger.com,1999:blog-1328313136038901535.post-9406541427008994812015-03-26T11:15:00.000-07:002015-03-26T11:15:09.420-07:00One Size Fits All—Right Now, But, What If…<span style="font-family: arial;"><!--[if gte mso 9]><xml>
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The typical clinical trial today involves
hundreds or even thousands of volunteers who are fairly similar (have the same
cancer with similar stage and similar prior therapy and maybe even similarities
in general health). Then two treatments are compared to each other in this
large group of patients. If one treatment fares better than the other, that <i style="mso-bidi-font-style: normal;">better</i> treatment becomes the new gold
standard treatment. That’s good. That’s progress! But it’s certainly not
perfect.</div>
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<br /></div>
<div class="MsoNormal" style="line-height: 200%;">
<b style="mso-bidi-font-weight: normal;">So what about the individual patient?</b></div>
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What is lost in this process is
knowledge about how these treatments affect individual patients; for example, <i style="mso-bidi-font-style: normal;">you</i>. The average benefit seen in a
clinical trial is not shared equally by all participants. Some patients are
fortunate to have cancers that are particularly responsive to available
treatments and these patients may benefit a great deal. Others may benefit a
little less and some may not benefit at all. A few may even be harmed by the
treatment as they experience unpleasant side effects along with little or no
effectiveness. </div>
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A clinical trial treatment is
judged by how it performed in the entire group of participants and not as much
by how each individual patient responded. <i style="mso-bidi-font-style: normal;">Over
the years, this approach has saved countless lives</i>. In most cases it’s the
best we have at the present time. What about the future? What’s on the horizon?</div>
<div class="MsoNormal" style="line-height: 200%;">
<br /></div>
<div class="MsoNormal" style="line-height: 200%;">
<b style="mso-bidi-font-weight: normal;">The Big Three New Directions</b></div>
<div class="MsoNormal" style="line-height: 200%;">
1 <b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;">Targeted Therapy</i></b><i style="mso-bidi-font-style: normal;">.</i> More and more cancer drugs are
designed to target specific defects that occur only in cancer cells and not in
the normal human body. This is the same process used in creating antibiotics
that attack the bacteria and not the human. As a result, antibiotics have been
enormously successful. It has been far more difficult to figure out what makes
a human cancer cell uniquely different from the regular human cells that it
came from. But drugs are now being designed to exploit these newly discovered
Achilles’ heels of cancer. For example, Imatinib Mesylate (aka <i style="mso-bidi-font-style: normal;">Gleevec</i>) (developed at OHSU) was one of
the first such drugs to become mainstream, revolutionizing the treatment of
Chronic Myelogenous Leukemia as well as several other cancers. </div>
<div class="MsoNormal" style="line-height: 200%;">
Targeted drugs have a good chance
of being both more effective and less toxic than most drugs currently in use.
Targeted drugs are also more amenable to individualized therapy. Since these
drugs have a specific target, it is possible to develop tests that examine the
cancer and determine if that particular target is present in a specific,
individual patient. </div>
<div class="MsoNormal" style="line-height: 200%;">
<br /></div>
<div class="MsoNormal" style="line-height: 200%;">
2 <b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;">Personalized Therapy</i></b><i style="mso-bidi-font-style: normal;">.</i> More clinical trials than ever before
are asking patients to consider a biopsy of their cancer as part of the
research. For cancers that circulate in the blood this may be possible with
just a simple blood sample. In other cases a needle biopsy might be needed to
get a sample. Don’t be surprised if you get such a request when you’re
contemplating a clinical trial. These tumor samples are being used to better
understand which cancers respond to which treatments. Fear of needles aside,
this is a good and progressive step in conducting clinical trials and providing
benefits for all those with cancer!</div>
<div class="MsoNormal" style="line-height: 200%;">
It is likely that in the future the
multi-thousand patient clinical trials that seek to measure benefit in the
entire group may be replaced by smaller studies that focus on subgroups of
cancers that have specific treatable defects. </div>
<div class="MsoNormal" style="line-height: 200%;">
<br /></div>
<div class="MsoNormal" style="line-height: 200%;">
3<b style="mso-bidi-font-weight: normal;"> <i style="mso-bidi-font-style: normal;">Pharmacogenomics</i></b>. Not
only can we not now tell in advance who will benefit from which treatment, we
are equally unable to predict who will develop serious side effects. Matching
drugs to cancers will require careful biologic analysis of the tumors. Predicting,
and therefore avoiding, side effects will require a careful biologic analysis
of the whole human being. </div>
<div class="MsoNormal" style="line-height: 200%;">
While our individual differences
are not due only to genetics, many of our differences and those things that
make us unique <i style="mso-bidi-font-style: normal;">are coded into our DNA</i>.
We expect that hidden within that code is the ability to predict how the body
will react to various medications and treatments. In the future, we hope to be
able to perform very sophisticated laboratory tests that will enable us to
predict which treatments will result in the greatest benefit and do the least
harm to each individual patient‑‑and for minimal cost. Let’s hope this all
happens sooner rather than later!</div>
<br />
<span style="font-family: arial;">
</span><br />
<div class="MsoNormal">
<br /></div>
<span style="font-family: arial;">
</span><br />
<span style="font-family: arial;">Post Text Here
</span><br />
<span style="font-family: arial;">To put a smile on your face see <a href="http://www.cancer-clinical-trials.com/p/clinical-trials-in-cartoons.html">Larry's latest cartoon.</a></span><br />
<span style="font-family: arial;">To learn more about clinical trials, take a look at <a href="http://tinyurl.com/cancer-clinical-trials-book">our book.</a></span><br />
<span style="font-family: arial;">
<img src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhAWYLVuUlu5Hq_Elg9pokI-Be5GFY8oe53iScn-8JSTfiAIDtmH6i7dl2al8n7es8vR4Jrb8RyXqdlAqt7geKEY8xbO2ZNy40uOc2nmpEwmUZCXPS2FRWvU4tlD8aTLWiV4kD8dX6S0Kg/s1600/WRITERS.jpg" height="75" width="100" /><br />
</span>
(c) 2012 Tom Beer and Larry AxmakerLarry Axmakerhttp://www.blogger.com/profile/03644176927295665033noreply@blogger.com0tag:blogger.com,1999:blog-1328313136038901535.post-25320866163574406922015-03-09T16:45:00.000-07:002015-03-09T16:45:11.114-07:00Cancer and Clinical Trials—by the numbers<span style="font-family: arial;"><!--[if gte mso 9]><xml>
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</span><br />
<div class="MsoNormal">
<span style="font-family: arial;">Every once in a while we find it helpful to take a step back
from clinical trial results, experimental drugs, and finding a clinical trial
to look at some other cancer information. Today it’s taking a look at the big
picture—the numbers, or as close to the facts as we can get. </span></div>
<div class="MsoNormal">
<br /></div>
<span style="font-family: arial;"><div class="MsoNormal">
<b style="mso-bidi-font-weight: normal;">In the Wide, Wide
World</b></div>
<div class="MsoNormal">
This year 9,000,000 people worldwide will die from cancer
and the number is rising. That is 13% of all deaths. The U.S. ranks 58<sup>th</sup>
in the rate of world cancer deaths. That means 57 countries have lower rates of
cancer deaths than we do. The rates are much higher in Poland and Hungary and much
lower in Mexico, Iran and many other countries. </div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
There are growing numbers of people in the world with
cancer. How can this be with all the improvements we have made in diagnosis and
treatment? Well, there are more and more older people throughout the world. The
number one risk factor in getting cancer is to get older. And, more people are
living longer with cancer. Then there are factors like pollution and smoking, which is still
very popular around the world.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<b style="mso-bidi-font-weight: normal;">Close to Home</b></div>
<div class="MsoNormal">
14.5 million living Americans have or have had cancer. 1.6
million more will be diagnosed this year and 589,000 will die from cancer. And,
of all those individuals, only about 3% (42,000) will ever volunteer to participate
in a clinical trial. You can help improve that statistic!</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
In the U.S. the 5-year cancer survival rate for all cancers
was 49% in 1977. It is 68% today—and much higher for some cancers such as
prostate (99%). Earlier diagnosis, better treatment, and lower smoking rates
have helped. The most common cancers in the U.S. are breast, prostate, and
lung. Breast and prostate cancer have high survival rates, lung cancer has a
very low survival rate‑‑still.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Over a lifetime your chance of getting cancer of any kind is
37% if you are a woman and 43% if you are a man. You can avoid some cancers (stay
out of the sun, don’t smoke) but others seem to just happen. </div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<b style="mso-bidi-font-weight: normal;">How About some $ and
Sense? </b></div>
<div class="MsoNormal">
Cancer is expensive. In the U.S., cancer treatment costs
exceed $88 billion each year. Half of that is for Doctor and out-patient
Hospital costs. 35% is for in-Hospital treatment and 11% is for prescription
drugs. That’s a lot of money to help us stay alive. And costs are going to increase.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<b style="mso-bidi-font-weight: normal;">Summary</b></div>
<div class="MsoNormal">
Cancer is very common, horrible, expensive, and
unpredictable. The numbers in this article won’t cure you, probably didn’t surprise
you, and will not likely change any of your behaviors and choices. But you never
know…</div>
<div class="MsoNormal">
<br /></div>
</span><br />
<br />
<span style="font-family: arial;">Post Text Here
</span><br />
<span style="font-family: arial;">To put a smile on your face see <a href="http://www.cancer-clinical-trials.com/p/clinical-trials-in-cartoons.html">Larry's latest cartoon.</a></span><br />
<span style="font-family: arial;">To learn more about clinical trials, take a look at <a href="http://tinyurl.com/cancer-clinical-trials-book">our book.</a></span><br />
<span style="font-family: arial;">
<img src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhAWYLVuUlu5Hq_Elg9pokI-Be5GFY8oe53iScn-8JSTfiAIDtmH6i7dl2al8n7es8vR4Jrb8RyXqdlAqt7geKEY8xbO2ZNy40uOc2nmpEwmUZCXPS2FRWvU4tlD8aTLWiV4kD8dX6S0Kg/s1600/WRITERS.jpg" height="75" width="100" /><br />
</span>
(c) 2012 Tom Beer and Larry AxmakerLarry Axmakerhttp://www.blogger.com/profile/03644176927295665033noreply@blogger.com0tag:blogger.com,1999:blog-1328313136038901535.post-62455494519115762462015-02-14T12:46:00.000-08:002015-02-14T12:51:11.146-08:00Nobody in a clinical trial wants to be given a placebo, whatever that is…<!--[if gte mso 9]><xml>
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</xml><![endif]--><span style="mso-bidi-font-weight: bold; mso-fareast-font-family: "Times New Roman"; mso-font-kerning: 16.0pt;">“Placebo” is often used in a
negative way. But that’s not necessarily true. Placebos are sometimes used in
clinical trials. A placebo is a biologically neutral substance packaged to look
like the real drug. Although often referred to as a <i style="mso-bidi-font-style: normal;">sugar pill</i>, many placebos are not even pills. They are simply
inactive compounds packaged to look, feel, and appear like an active drug. They
may be an injection, IV infusion, capsule, a cream, an inhaler, a skin patch,
or take any other form that is used by an active drug. </span><br />
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<span style="mso-bidi-font-weight: bold; mso-fareast-font-family: "Times New Roman"; mso-font-kerning: 16.0pt;">Placebos are used when the
purpose of the research is to compare different approaches to treatment. The
placebo helps ensure that the study is <i style="mso-bidi-font-style: normal;">double
blinded</i> which means neither the doctor nor the patient knows which
treatment is being administered. Many cancer patients are understandably
concerned that they might get a <i style="mso-bidi-font-style: normal;">sugar
pill</i> instead of a real treatment. This is often the first question the
physician researcher hears when a clinical trial is brought up as an option,
“Will I get the real thing or just a sugar pill?”</span><br />
</div>
<div class="MsoNormal">
<b><span style="mso-fareast-font-family: "Times New Roman"; mso-font-kerning: 16.0pt;">When placebos are used</span></b></div>
<div class="MsoNormal">
<span style="mso-bidi-font-weight: bold; mso-fareast-font-family: "Times New Roman"; mso-font-kerning: 16.0pt;">The fundamental principle
that defines when placebos are appropriate is rather simple: <i style="mso-bidi-font-style: normal;">if you have cancer, and a treatment that works
is available, a placebo cannot be used instead</i>. Period‑‑end of story.
Research <i style="mso-bidi-font-style: normal;">is not</i> and <i style="mso-bidi-font-style: normal;">cannot</i> be about withholding effective
treatments from patients with cancer. A placebo can be used in two research situations:</span></div>
<div class="MsoNormal">
<span style="mso-bidi-font-weight: bold; mso-fareast-font-family: "Times New Roman"; mso-font-kerning: 16.0pt;">1<span style="mso-tab-count: 1;"> </span><i style="mso-bidi-font-style: normal;">There is no effective
treatment</i> and the standard <i style="mso-bidi-font-style: normal;">treatment</i>
would be observation or perhaps supportive treatment (treatments designed to lessen
symptoms but not treat the disease).</span></div>
<div class="MsoNormal">
<span style="mso-bidi-font-weight: bold; mso-fareast-font-family: "Times New Roman"; mso-font-kerning: 16.0pt;">2<span style="mso-tab-count: 1;"> </span><i style="mso-bidi-font-style: normal;">There is an effective
treatment</i> and this treatment is being given to all patients in the study.
The placebo is being <i style="mso-bidi-font-style: normal;">added</i> to the
known effective treatment to allow a comparison between the standard treatment <i style="mso-bidi-font-style: normal;">and</i> a combination of the standard
treatment plus a new drug of unknown effectiveness.</span></div>
<div class="MsoNormal">
<br />
<b><span style="mso-fareast-font-family: "Times New Roman"; mso-font-kerning: 16.0pt;">The Placebo Effect (this is kind of weird) </span></b></div>
<div class="MsoNormal">
<span style="mso-bidi-font-weight: bold; mso-fareast-font-family: "Times New Roman"; mso-font-kerning: 16.0pt;">The most mysterious benefit
of having a placebo in a study is that <i style="mso-bidi-font-style: normal;">placebos
actually do work</i>! Now you may think we are completely losing our minds
(always a possibility), but it is true! The degree to which placebos work
varies considerably depending on what disease is being studied, but it stands
to reason that if we are going to devise a fancy, expensive, patented new drug
with an unpronounceable name, it should produce results better than a mere
sugar pill. According to the <i style="mso-bidi-font-style: normal;">American
Cancer Society</i>, placebos have an effect on about <i style="mso-bidi-font-style: normal;">one in three</i> patients. Often the result is a reported improvement in
a symptom or in quality of life. Sometimes it could actually be a new side
effect. The mechanisms through which placebos work may represent, to some
extent, the importance of the mind-body connection. </span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<span style="mso-bidi-font-weight: bold; mso-fareast-font-family: "Times New Roman"; mso-font-kerning: 16.0pt;">A placebo can reinforce
patients’ belief that they will get better and so they actually do. In general,
placebo effects are seen as symptoms or things people feel. The actual
shrinkage of cancer tumors would be extraordinary. Nevertheless, many studies
of new cancer drugs look beyond tumor shrinkage and length of life following a
cancer diagnosis. They examine quality of life, symptoms of cancer, and side
effects of the drug. Placebos allow us to see the true picture of what a new
drug can offer beyond what you could get from a <i style="mso-bidi-font-style: normal;">sugar pill</i>.</span></div>
<div class="MsoNormal">
<span style="mso-bidi-font-weight: bold; mso-fareast-font-family: "Times New Roman"; mso-font-kerning: 16.0pt;">There’s more to learn about
the placebo. Watch for the next chapter!</span></div>
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Post Text Here
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<span style="font-family: arial;">To put a smile on your face see <a href="http://www.cancer-clinical-trials.com/p/clinical-trials-in-cartoons.html">Larry's latest cartoon.</a></span><br />
<span style="font-family: arial;">To learn more about clinical trials, take a look at <a href="http://tinyurl.com/cancer-clinical-trials-book">our book.</a></span><br />
<span style="font-family: arial;">
<img src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhAWYLVuUlu5Hq_Elg9pokI-Be5GFY8oe53iScn-8JSTfiAIDtmH6i7dl2al8n7es8vR4Jrb8RyXqdlAqt7geKEY8xbO2ZNy40uOc2nmpEwmUZCXPS2FRWvU4tlD8aTLWiV4kD8dX6S0Kg/s1600/WRITERS.jpg" height="75" width="100" /><br />
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(c) 2012 Tom Beer and Larry AxmakerLarry Axmakerhttp://www.blogger.com/profile/03644176927295665033noreply@blogger.com0tag:blogger.com,1999:blog-1328313136038901535.post-46322214838934707282015-01-29T11:31:00.000-08:002015-01-29T11:31:56.371-08:00The Right Clinical Trial for You—Part 4<span style="font-family: arial;"><!--[if gte mso 9]><xml>
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<span style="font-family: arial;"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%;"></span><b style="mso-bidi-font-weight: normal;"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;">Attitudes,
Emotions, and Reality in Choosing a Clinical Trial</span></b>
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<span style="font-family: arial;"><div class="MsoNormal" style="line-height: 200%;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;">Having cancer is a medical
reality. Thinking about cancer can have a significant emotional impact on you,
your family, and your friends. The process of coming to terms with your
diagnosis, maintaining your life as normally as possible, and then looking at
clinical trials can be emotionally difficult.</span></div>
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<br /></div>
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<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;">First of all, not many people
actually believe they will ever be diagnosed with cancer. We all know <i style="mso-bidi-font-style: normal;">other people</i> who have cancer, but in our
mind it just couldn’t happen to us. That’s just human nature. <i style="mso-bidi-font-style: normal;">But, unfortunately, it can happen to us</i>.
The facts say about half of us will get diagnosed with cancer in our lifetime—some
of us more than once. </span></div>
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<br /></div>
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<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;">Most of us probably fit into
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have gone through a lot of emotional ups and downs already. Being diagnosed with
cancer can be a traumatic experience. You already know all about that. Calling
yourself a <i style="mso-bidi-font-style: normal;">survivor</i> has a certain
determined, optimistic sound to it. That’s a good place to start.</span></div>
<div class="MsoNormal" style="line-height: 200%;">
<br /></div>
<div class="MsoNormal" style="line-height: 200%;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;">Some people feel so
discouraged after a cancer diagnosis they can’t really focus on anything else‑‑at
least for a while. It’s normal to initially feel depressed and anxious, “I’ve
got incurable cancer and I’m going to die!” That’s a horrible feeling
regardless of whether it’s true or not. </span></div>
<div class="MsoNormal" style="line-height: 200%;">
<br /></div>
<div class="MsoNormal" style="line-height: 200%;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;">Whatever you feel is very
real to you. Your feelings may not be logical, rational, or reflect reality
(that’s why they’re called <i style="mso-bidi-font-style: normal;">feelings</i>
and not facts) but they have a major impact on what you think, how you act, and
what you decide to do or not to do. That includes choosing to join (or not to
join) a clinical trial. </span></div>
<div class="MsoNormal" style="line-height: 200%;">
<br /></div>
<div class="MsoNormal" style="line-height: 200%;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;">According to the National
Cancer Institute, about half of those with incurable cancer experience some
serious emotional distress and anxiety. People with cancer can experience PTSD
(post-traumatic stress disorder), just the same as accident victims or soldiers
in combat. Cancer survivors commonly experience fatigue which can make it more
difficult to make decisions and take actions that might benefit you. As if the
cancer itself wasn’t bad enough!</span></div>
<div class="MsoNormal" style="line-height: 200%;">
<br /></div>
<div class="MsoNormal" style="line-height: 200%;">
<b style="mso-bidi-font-weight: normal;"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;">“Just
leave me alone!”</span></b></div>
<div class="MsoNormal" style="line-height: 200%;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;">Whatever you’re feeling is
probably shared by many others with cancer. It’s common to want to be alone and
avoid the sympathy and concern of others, even your family and closest friends.
Isolation might seem to help, but more likely being alone will increase your
stress. You can feel sad, happy, angry, and discouraged‑‑all at the same time.
This emotional roller coaster can keep you from getting the help and support
you need and from making important decisions. Try not to let that happen; tell
yourself that you’re in control and then <i style="mso-bidi-font-style: normal;">take
charge</i>!</span></div>
<div class="MsoNormal" style="line-height: 200%;">
<br /></div>
<div class="MsoNormal" style="line-height: 200%;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;">The American Cancer Society
(ACS) suggests some things you can do to help manage worry and stress:</span></div>
</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;"><span style="font-family: arial;">1 </span>Just talking about your
feelings can help relieve worry and stress.</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;"><span style="font-family: arial;"> </span></span><br />
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;"><span style="font-family: arial;">2 </span>Trying to relax with
deep breathing and other techniques can be helpful. Doing it regularly
works best.</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;"></span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;"> </span><br />
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;">3 Allowing yourself to
feel sad and frustrated without feeling guilty about it is perfectly OK
and you have every right to do so.</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;"> </span><br />
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;">4 Choosing the right
person to talk with can be important. That person could be a good friend,
family member, or a spiritual counselor.</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;"></span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;"> </span><br />
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;">5 Spiritual help is useful
for many people.</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;"> </span><br />
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;">6 If the worry persists or
gets worse, get help from a mental health professional.</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;"></span><span style="font-family: arial;">
</span><br />
<div class="MsoNormal" style="line-height: 200%;">
<br /></div>
<span style="font-family: arial;">
<div class="MsoNormal" style="line-height: 200%;">
<b style="mso-bidi-font-weight: normal;"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;">And you
want me to join a clinical trial on top of all that?</span></b></div>
<div class="MsoNormal" style="line-height: 200%;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;">In the middle of the
emotional roller-coaster and facing a relapse or progression of your cancer,
you’re now considering experimental medicine‑‑a clinical trial. It can be hard
to make calm, logical decisions when you are in the midst of a personal crisis.
To top it all off, the information you’ve been hearing from others may not be
completely accurate or very helpful.</span></div>
<div class="MsoNormal" style="line-height: 200%;">
<br /></div>
<div class="MsoNormal" style="line-height: 200%;">
<b style="mso-bidi-font-weight: normal;"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;">Human
Nature</span></b></div>
<div class="MsoNormal" style="line-height: 200%;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;">Good old human nature can
trip you up on the way to considering a clinical trial. There is a strong
tendency for some (probably many) people, when under stress or in crisis (being
diagnosed with cancer, for example), to resist any change or new treatment that
takes them out of their own comfort zone. Just a few thoughts that might come
up:</span></div>
</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;">“I don’t have the time”</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;"> </span><br />
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;">“It’s just a waste of my
time.”</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;"></span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;"> </span><br />
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;">“What’s the use?”</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;"> </span><br />
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;">“I know it won’t work.”</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;"></span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;"> </span><br />
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;">“What do those doctors
and drug companies know?”</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;"> </span><br />
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;">“They just want to use
me to make lots of money for them!”</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;"></span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;"> </span><br />
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;">“There’s no way I’m
going to be somebody’s guinea pig!” </span><span style="font-family: arial;">
</span><br />
<div class="MsoListParagraph" style="line-height: 200%; mso-list: l1 level1 lfo2; tab-stops: list .5in; text-indent: -.25in;">
<span style="font-family: arial;"><span style="font-family: Symbol; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7.0pt "Times New Roman";">
</span></span></span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;">“And what about those stories of clinical
trials gone wrong?” </span></span></div>
<span style="font-family: arial;">
<div class="MsoNormal" style="line-height: 200%; margin-bottom: .0001pt; margin-bottom: 0in;">
<b style="mso-bidi-font-weight: normal;"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;">Your Choice</span></b></div>
<div class="MsoNormal" style="line-height: 200%; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi;">Most
clinical trial participants report a good experience—but not necessarily a
cure. Spending time with the medical professionals and sometimes with other
participants can be good for your mind and body. And you can always choose to
opt out.</span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%;"> </span></div>
<div class="MsoNormal">
<br /></div>
Post Text Here
</span><br />
<span style="font-family: arial;">To put a smile on your face see <a href="http://www.cancer-clinical-trials.com/p/clinical-trials-in-cartoons.html">Larry's latest cartoon.</a></span><br />
<span style="font-family: arial;">To learn more about clinical trials, take a look at <a href="http://tinyurl.com/cancer-clinical-trials-book">our book.</a></span><br />
<span style="font-family: arial;">
<img src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhAWYLVuUlu5Hq_Elg9pokI-Be5GFY8oe53iScn-8JSTfiAIDtmH6i7dl2al8n7es8vR4Jrb8RyXqdlAqt7geKEY8xbO2ZNy40uOc2nmpEwmUZCXPS2FRWvU4tlD8aTLWiV4kD8dX6S0Kg/s1600/WRITERS.jpg" height="75" width="100" /><br />
</span>
(c) 2012 Tom Beer and Larry AxmakerLarry Axmakerhttp://www.blogger.com/profile/03644176927295665033noreply@blogger.com1tag:blogger.com,1999:blog-1328313136038901535.post-75369301774129684452015-01-03T13:26:00.000-08:002015-01-03T13:26:29.469-08:00The Right Clinical Trial for You—Part 3<span style="font-family: arial;"><!--[if gte mso 9]><xml>
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<div class="MsoNormal">
<b style="mso-bidi-font-weight: normal;"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%;">What
Should You Expect from the Clinical Trial?</span></b>
</div>
</span><span style="font-family: arial;"><div class="ColorfulList-Accent12CxSpMiddle" style="line-height: 200%; margin-left: 0in; mso-add-space: auto; text-indent: 0in;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%;">You should be comfortable
and know you will be treated well when you participate in a trial. You
certainly <i style="mso-bidi-font-style: normal;">hope</i> the trial will be a
success and your cancer will be managed (or even cured, but that is unlikely),
but you <i style="mso-bidi-font-style: normal;">know</i> that there are no
guarantees. What you <i style="mso-bidi-font-style: normal;">can</i> expect is
that your health and cancer status will be monitored closely, that side effects
will be managed expertly, and that study doctors and staff will be responsive
to your questions and needs. If a drug is not currently approved for use, the
drug will be provided free of charge. Some of the tests you will undergo, those
done specifically for the research process (e.g., extra biopsies of your cancer
or blood samples to measure drug levels), are also provided to you free of
charge in most cases. In most clinical trials the routine parts of your care
(that would be done if you were getting standard treatment) are not provided
free of charge, but are billed to your insurance provider. </span></div>
<div class="ColorfulList-Accent12CxSpMiddle" style="line-height: 200%; margin-left: 0in; mso-add-space: auto; text-indent: 0in;">
<br /></div>
<div class="ColorfulList-Accent12CxSpMiddle" style="line-height: 200%; margin-left: 0in; mso-add-space: auto; text-indent: 0in;">
<b style="mso-bidi-font-weight: normal;"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%;">What
can I expect from my doctor and investigative team?</span></b></div>
<div class="ColorfulList-Accent12CxSpMiddle" style="line-height: 200%; margin-left: 0in; mso-add-space: auto; text-indent: 0in;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%;">You can, and should,
expect close attention by a team that is often larger than what you would
encounter during routine care. </span></div>
<div class="ColorfulList-Accent12CxSpMiddle" style="line-height: 200%; margin-left: 0in; mso-add-space: auto; text-indent: 0in;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%;">You can certainly
expect exceptional care from the whole team. You will almost certainly get more
medical attention than if you were on standard care. You should get regular
reports about your progress. If you don’t‑‑<i style="mso-bidi-font-style: normal;">ask</i>!
You’re getting treatment for your cancer <i style="mso-bidi-font-style: normal;">and</i>
you’re also helping the investigators. You’re a partner in the trial. Be sure
to ask, early on, who is the right person for you to contact for specific
concerns. Who should you call if you have a question about a scheduling matter,
and who do you call if you are not feeling well, have a new side effect, or if
you have a medical question? Having that information clarified from the start
and having all the right contact information for <i style="mso-bidi-font-style: normal;">your</i> research team can go a long way in making the process run
smoothly and comfortably for you. You will almost certainly get more medical
attention than if you were in standard care. You should get regular reports
about your progress. If you don’t—ASK! You’re getting treatment AND you are
helping the investigators. </span></div>
<div class="ColorfulList-Accent12CxSpMiddle" style="line-height: 200%; margin-left: 0in; mso-add-space: auto; text-indent: 0in;">
<br /></div>
<div class="ColorfulList-Accent12CxSpMiddle" style="line-height: 200%; margin-left: 0in; mso-add-space: auto; text-indent: 0in;">
<b style="mso-bidi-font-weight: normal;"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%;">Am
I free to quit if I want to?</span></b></div>
<div class="ColorfulList-Accent12CxSpMiddle" style="line-height: 200%; margin-left: 0in; mso-add-space: auto; text-indent: 0in;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%;">YES! You agreed to
participate, but you <i style="mso-bidi-font-style: normal;">always</i> have the
right to quit, whether due to side effects or if you’re not comfortable with
the trial or for any reason you choose. Talk to your doctor and your trial team
before you decide. They may be able to resolve your concerns and answer your
questions so you will be able to stay in the program. </span></div>
<div class="ColorfulList-Accent12CxSpMiddle" style="line-height: 200%; margin-left: 0in; mso-add-space: auto; text-indent: 0in;">
<br /></div>
<div class="ColorfulList-Accent12CxSpMiddle" style="line-height: 200%; margin-left: 0in; mso-add-space: auto; text-indent: 0in;">
<b style="mso-bidi-font-weight: normal;"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%;">What
if I have side effects? How will I know if I should be concerned?</span></b></div>
<div class="ColorfulList-Accent12CxSpMiddle" style="line-height: 200%; margin-left: 0in; mso-add-space: auto; text-indent: 0in;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%;">A new physical or
emotional sensation that is out of the ordinary for you could be an adverse
effect. Tell the nurse and doctor about it right away. It is better if you tell
them sooner rather than later. There may be ways to manage your side effects.
It may also turn out to be unrelated to the trial and could be treated
separately while you continue in the trial. </span></div>
<div class="ColorfulList-Accent12CxSpLast" style="line-height: 200%; margin-left: 0in; mso-add-space: auto; text-indent: 0in;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%;">All of this is
important because an adverse effect from an experimental drug is different from
ordinary side effects, mostly in that less is known about it. It could start
out mild and get worse over time if not attended to; sometimes this can happen
very quickly. It should be brought to the attention of the research team
promptly so they can be evaluated.</span></div>
<div class="MsoNormal">
<br /></div>
<div class="ColorfulList-Accent12CxSpFirst" style="line-height: 200%; margin-left: 0in; mso-add-space: auto; text-indent: 0in;">
<b style="mso-bidi-font-weight: normal;"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%;">Bottom
Line</span></b></div>
<div class="ColorfulList-Accent12CxSpMiddle" style="line-height: 200%; margin-left: .25in; mso-add-space: auto; text-indent: 0in;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%;">1<span style="mso-spacerun: yes;"> </span>Clinical trials are tightly regulated and
closely supervised by the study team, institutional committees, independent
boards, pharmaceutical companies, and the government. The scrutiny is far more
extensive than that of routine cancer care.</span></div>
<div class="ColorfulList-Accent12CxSpMiddle" style="line-height: 200%; margin-left: .25in; mso-add-space: auto; text-indent: 0in;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%;">2<span style="mso-spacerun: yes;"> </span>Most of your cancer care while you’re
participating in a study will be billed to and covered by your health
insurance. Items that are purely for research, and not done to take care of you,
are generally provided free of charge.</span></div>
<div class="ColorfulList-Accent12CxSpMiddle" style="line-height: 200%; margin-left: .25in; mso-add-space: auto; text-indent: 0in;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%;">3<span style="mso-spacerun: yes;"> </span>It is important to establish and maintain
clear communication with your entire study team:</span></div>
<div class="ColorfulList-Accent12CxSpMiddle" style="line-height: 200%; margin-left: .75in; mso-add-space: auto; text-indent: 0in;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%;">A <span style="mso-spacerun: yes;"> </span>Find out which members of the team are the
right contacts for different types of questions and concerns.</span></div>
<div class="ColorfulList-Accent12CxSpMiddle" style="line-height: 200%; margin-left: .75in; mso-add-space: auto; text-indent: 0in;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%;">B <span style="mso-spacerun: yes;"> </span>Let your study team know about adverse
effects (side effects) or concerns promptly.</span></div>
<div class="ColorfulList-Accent12CxSpMiddle" style="line-height: 200%; margin-left: .75in; mso-add-space: auto; text-indent: 0in;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%;">C <span style="mso-spacerun: yes;"> </span>Don’t try to solve problems that arise on
your own or wait until your next appointment‑‑contact your team whenever you
need to.</span></div>
<div class="ColorfulList-Accent12CxSpMiddle" style="line-height: 200%; margin-left: .25in; mso-add-space: auto; text-indent: 0in;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%;">4<span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span>You are always free to stop being a part of
the study. If you are thinking about stopping, be up front with your doctor and
research team. You may learn that they can solve the problems or address your
concerns without stopping the study treatment.</span></div>
<div class="ColorfulList-Accent12CxSpLast" style="line-height: 200%; margin-left: .25in; mso-add-space: auto; text-indent: 0in;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%;">5<span style="mso-spacerun: yes;"> </span>Seek the support of your oncologist, your
primary care doctor, your spouse, and those around you while you are making
decisions about whether to sign up for a study and while you are participating
in the trial.</span></div>
<div class="MsoNormal">
<br /></div>
</span><br />
<span style="font-family: arial;">Post Text Here
</span><br />
<span style="font-family: arial;">To put a smile on your face see <a href="http://www.cancer-clinical-trials.com/p/clinical-trials-in-cartoons.html">Larry's latest cartoon.</a></span><br />
<span style="font-family: arial;">To learn more about clinical trials, take a look at <a href="http://tinyurl.com/cancer-clinical-trials-book">our book.</a></span><br />
<span style="font-family: arial;">
<img src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhAWYLVuUlu5Hq_Elg9pokI-Be5GFY8oe53iScn-8JSTfiAIDtmH6i7dl2al8n7es8vR4Jrb8RyXqdlAqt7geKEY8xbO2ZNy40uOc2nmpEwmUZCXPS2FRWvU4tlD8aTLWiV4kD8dX6S0Kg/s1600/WRITERS.jpg" height="75" width="100" /><br />
</span>
(c) 2012 Tom Beer and Larry AxmakerLarry Axmakerhttp://www.blogger.com/profile/03644176927295665033noreply@blogger.com0tag:blogger.com,1999:blog-1328313136038901535.post-85879896373087375192014-12-18T16:27:00.001-08:002014-12-18T16:27:39.561-08:00The Right Clinical Trial for You--Part 2<br />
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<![endif]--><b><span lang="X-NONE" style="font-family: "Times New Roman","serif"; font-size: 12.0pt; font-style: normal; line-height: 200%; mso-bidi-font-style: italic;">What are the Costs of Clinical
Trials?</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%;"> </span></b><span style="font-weight: normal;"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%;"> </span></span><br />
<h2 style="line-height: 200%; margin-left: 0in; text-align: left; text-indent: 0in;">
<span style="font-weight: normal;"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%;">When you think about
the costs of a clinical trial, you may be thinking about the costs of your care
in a clinical trial. These costs are called <i style="mso-bidi-font-style: normal;">clinical
care costs</i>, things like lab tests, scans, etc. As expensive as those may
be, these actually are only a fraction of the total costs of the study. The
people who work to make clinical trials a reality are the largest expense.
Study coordinators, study nurses, and investigators are the folks you are
likely to meet. Pharmacists, laboratory technicians who handle your blood
specimens, regulatory specialists (who make sure the trial has all the necessary
approvals), and all the people who oversee the clinical
trial process and make sure it is being done correctly are working in the
background; you will probably never meet them. That seems like a lot of people,
but that is only the tip of the iceberg. These are just the people working at
the one hospital or research center you are visiting.</span></span></h2>
<h2 style="line-height: 200%; margin-left: 0in; text-indent: 0in;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%;"></span><span style="font-weight: normal;"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%;">There is another large
group of people at the pharmaceutical company (or subcontracted by the
pharmaceutical company) who develop the study procedures, receive, review, and
analyze the results, monitor all side effects, disseminate information to all
the researchers (for example, new serious side effect information has to be
circulated quickly to everyone who is involved), and interact with the FDA.
As you can see, behind every clinical trial, there is an army of people and it
all costs a small (or even a large) fortune.</span></span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%;"></span> </h2>
<b><span lang="X-NONE" style="font-family: "Times New Roman","serif"; font-size: 12.0pt; font-style: normal; line-height: 200%; mso-bidi-font-style: italic;">So Who Pays for all This?</span></b>
<div class="ColorfulList-Accent12CxSpFirst" style="line-height: 200%; margin-left: 0in; mso-add-space: auto; text-indent: 0in;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%;">That might be
interesting, but it’s probably a safe bet that you care most about the clinical
care costs that will affect you. In general, items that are solely for research
(i.e. the study drug and highly specialized tests that would not otherwise be
done to take care of you and your cancer) are covered by the study budget and
are free to you. All other costs of medical care; the sorts of things that you
would generally expect to need even if you were not in a clinical trial, are
billed to you and your health insurance. </span></div>
<div class="ColorfulList-Accent12CxSpFirst" style="line-height: 200%; margin-left: 0in; mso-add-space: auto; text-indent: 0in;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%;"> </span></div>
<div class="ColorfulList-Accent12CxSpLast" style="line-height: 200%; margin-left: 0in; mso-add-space: auto; text-indent: 0in;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%;">The costs of running
the study are borne by the pharmaceutical company for trials that are sponsored
by a company. Not all studies have an industry sponsor. Some research ideas,
although important, are unlikely to be tested by a pharmaceutical company. For
example, if we find that a commonly used drug that is generic (and cheap) could
have a beneficial use in cancer therapy, there is almost never a pharmaceutical
company that is willing to get involved. The lack of patent protection and
inexpensive cost of generic drugs makes this type research a lousy business
proposition.</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%;"> </span></div>
<div class="ColorfulList-Accent12CxSpLast" style="line-height: 200%; margin-left: 0in; mso-add-space: auto; text-indent: 0in;">
<br /></div>
<div class="ColorfulList-Accent12CxSpLast" style="line-height: 200%; margin-left: 0in; mso-add-space: auto; text-indent: 0in;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%;"> </span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%;">Such studies are
typically designed and led by an individual researcher. The investigator must
also find the funding to support it. Sometimes that involves a grant from the
pharmaceutical industry, a grant from a federal source (most commonly the
National Cancer Institute or Department of Defense), or a grant from a private
organization such as the American Cancer Society. Some studies are funded by
philanthropic donors or even the hospital itself. And some studies have no
funding at all. Normally such studies would just not get done, but what often
happens is that the investigator’s team donates their time.
University administrators frown on unfunded studies because the people involved
still get their salaries‑‑from the university. Academic professors can be quite
innovative about these sorts of things when they are truly excited about a new
idea.</span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal" style="line-height: 200%;">
<b style="mso-bidi-font-weight: normal;"><span style="font-family: "Times New Roman","serif";">Costs of Your Care
and Insurance Coverage of Cancer Clinical Trials</span></b><span style="font-family: "Times New Roman","serif";"></span></div>
<div class="MsoNormal" style="line-height: 200%;">
<span style="font-family: "Times New Roman","serif";"> </span><i style="mso-bidi-font-style: normal;"><span style="font-family: "Times New Roman","serif";">Everyone worries about costs</span></i><span style="font-family: "Times New Roman","serif";"> </span></div>
<span style="font-family: "Times New Roman","serif";">Misconceptions
and concerns about healthcare costs during cancer clinical trials are very
common. Some patients (and some doctors) think that experimental treatment is
always free. <i style="mso-bidi-font-style: normal;">This is almost never true.</i>
There are some studies that do provide all of the care for free, but in the
world of cancer research they are more often the exception than the rule. </span>
<div class="MsoNormal" style="line-height: 200%;">
<br /></div>
<span style="font-family: "Times New Roman","serif";">For
the studies that you would be interested in, those that seek to <i style="mso-bidi-font-style: normal;">treat</i> your cancer, your health insurance
will be billed for many elements of your care. It is always
spelled out in the consent form; but it may be difficult to sort out. Check out
the fine print and ask a health professional for help if it seems confusing.</span>
<div class="MsoNormal" style="line-height: 200%;">
<br /></div>
<span style="font-family: "Times New Roman","serif";">Is
your health insurance willing to pay? If so, how much? Is there a chance that
you will get stuck with the bill? It could happen, but much can be done to
prevent this if you are proactive. Until all patients with
cancer can expect a reliable cure, well-designed clinical trials should be part
of <i style="mso-bidi-font-style: normal;">standard care</i>. Unfortunately there
is no single answer that fits everyone. Read on to learn how you can make sure
that there are no financial surprises in your clinical trial.</span>
<div class="MsoNormal" style="line-height: 200%;">
<br /></div>
<div class="MsoNormal" style="line-height: 200%;">
<b style="mso-bidi-font-weight: normal;"><span style="font-family: "Times New Roman","serif";">Medicare Comes
Through</span></b></div>
<span style="font-family: "Times New Roman","serif";">If
you are over the age of sixty-five, chances are Medicare is a part (or even
all) of your health care coverage. Many insurance companies follow, to one
extent or another, the approach that Medicare takes in deciding what it will
cover and what it won’t. </span>
<div class="MsoNormal" style="line-height: 200%;">
<br /></div>
<span style="font-family: "Times New Roman","serif";">Since
the year 2000, Medicare <span style="color: black;">covers the <i style="mso-bidi-font-style: normal;">routine costs </i>of<i style="mso-bidi-font-style: normal;"> qualifying clinical trials</i>. In addition, Medicare covers costs of
diagnosing and caring for complications arising from participation in all
qualifying clinical trials. As with all legal matters, it is worth
understanding the key definitions. </span></span>
<div class="MsoNormal" style="line-height: 200%;">
<br /></div>
<i style="mso-bidi-font-style: normal;"><span style="color: black; font-family: "Times New Roman","serif";">Routine costs </span></i><span style="color: black; font-family: "Times New Roman","serif";">are those items and
services that are generally available to all Medicare beneficiaries. That would
include doctor visits, routine labs, scans, and tests necessary to monitor your
condition. Medicare also covers the costs associated with the giving of the
experimental agent (not a big deal if it’s a pill but if it’s an IV infusion
this can become expensive and it’s good to know it’s covered). If Medicare
doesn’t cover something normally (i.e. cosmetic surgery), it would not cover it
while you are a part of a clinical trial. Medicare does not cover the
experimental drug or device itself (the actual pills, for example) and items or
services that are used solely to gather and analyze research data and are not
being done to take care of the patient (like blood drug levels or exploratory
tests). </span>
<div class="MsoNormal" style="line-height: 200%;">
<br /></div>
<span style="color: black; font-family: "Times New Roman","serif";">Most of the time these definitions are pretty clear. One <i style="mso-bidi-font-style: normal;">gray zone</i> is a situation where something
that is routinely done is required more frequently during the study than would
be done ordinarily. Let’s say a study wants a CT scan twice a year, but if you
weren’t in a trial, you’d most likely only get one a year. This is a gray area
because, in most cases, there is not an absolute standard for how often
patients need blood tests or scans when they are receiving care for cancer.
Some situations require more frequent monitoring than others. Some doctors (and
some patients) prefer more frequent monitoring than others. <i style="mso-bidi-font-style: normal;">The Standard</i> is really a range of how
doctors actually practice. There are situations where something that would
ordinarily be considered quite routine is done so frequently in a study that it
won’t be covered by Medicare. Your research team and the institutional
oversight committee (IRB‑‑see chapter 9) are expected to pay attention to these
matters and identify situations where Medicare or your insurance won’t pay. In
these situations, the trial sponsor would usually be expected to pay; you’ll
obviously want to know in advance if it’s going to come out of your pocket.</span>
<div class="MsoNormal" style="line-height: 200%;">
<br /></div>
<span style="color: black; font-family: "Times New Roman","serif";">If you notice that the study you are considering requires very
frequent tests, ask about it. Check in with your study team about the costs of
those tests and who pays for them. Many institutions develop tables called <i style="mso-bidi-font-style: normal;">Costs of Care</i> or <i style="mso-bidi-font-style: normal;">Clinical Billing Schedule</i> tables for each study. These tables spell
out every planned item and service that is a part of the study and make it
clear if that particular item will be provide free of charge or billed to your
insurance.</span><div class="MsoNormal">
<span style="font-family: "Times New Roman","serif"; mso-no-proof: yes;"><br /></span></div>
<div class="MsoNormal" style="line-height: 200%;">
<b style="mso-bidi-font-weight: normal;"><span style="font-family: "Times New Roman","serif";">The Bottom Line</span></b></div>
<div class="ColorfulList-Accent12CxSpFirst" style="line-height: 200%; mso-list: l0 level1 lfo1; tab-stops: list .5in; text-indent: -.25in;">
<span style="font-family: Symbol; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7.0pt "Times New Roman";"> </span></span></span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%;">1 Until standard cancer therapy is much
more effective and reliable cancer cures are common, participation in clinical
trials should be an option for all cancer patients.</span></div>
<div class="ColorfulList-Accent12CxSpMiddle" style="line-height: 200%; mso-list: l0 level1 lfo1; tab-stops: list .5in; text-indent: -.25in;">
<span style="font-family: Symbol; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7.0pt "Times New Roman";">
</span></span></span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%;">2 Medicare covers routine costs of care
for patients who participate in qualified clinical trials. The investigational
drugs or devices themselves and procedures that are purely for research
purposes (not designed to care for you) are not covered. Services that would
not normally be covered under Medicare are not covered.</span></div>
<div class="ColorfulList-Accent12CxSpMiddle" style="line-height: 200%; mso-list: l0 level1 lfo1; tab-stops: list .5in; text-indent: -.25in;">
<span style="font-family: Symbol; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7.0pt "Times New Roman";">
</span></span></span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%;">3 Many insurers have policies that provide
for similar coverage, but this varies from plan to plan and state to state.</span></div>
<div class="ColorfulList-Accent12CxSpMiddle" style="line-height: 200%; mso-list: l0 level1 lfo1; tab-stops: list .5in; text-indent: -.25in;">
<span style="font-family: Symbol; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7.0pt "Times New Roman";">
</span></span></span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%;">4 The majority of states have now passed
laws that require coverage for clinical trial participants.</span></div>
<div class="ColorfulList-Accent12CxSpMiddle" style="line-height: 200%; mso-list: l0 level1 lfo1; tab-stops: list .5in; text-indent: -.25in;">
<span style="font-family: Symbol; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7.0pt "Times New Roman";">
</span></span></span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%;">5 The Health Care Reform Act of 2010
requires all health plans to cover clinical trials by January 1, 2014.</span></div>
<div class="ColorfulList-Accent12CxSpMiddle" style="line-height: 200%; mso-list: l0 level1 lfo1; tab-stops: list .5in; text-indent: -.25in;">
<span style="font-family: Symbol; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7.0pt "Times New Roman";">
</span></span></span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%;">6 Large companies that are self-insured
are regulated by the federal ERISA law and may not be impacted by state laws.
ERISA does not address clinical trials.</span></div>
<div class="ColorfulList-Accent12CxSpMiddle" style="line-height: 200%; mso-list: l0 level1 lfo1; tab-stops: list .5in; text-indent: -.25in;">
<span style="font-family: Symbol; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7.0pt "Times New Roman";">
</span></span></span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%;">7 Your research team should communicate
with your insurer to gain approval for your coverage before you begin
participation.</span></div>
<div class="ColorfulList-Accent12CxSpLast" style="line-height: 200%; mso-list: l0 level1 lfo1; tab-stops: list .5in; text-indent: -.25in;">
<span style="font-family: Symbol; font-size: 12.0pt; line-height: 200%; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7.0pt "Times New Roman";"> </span></span></span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 200%;">8 If you are denied coverage, work with
your doctor and research team to appeal. Appealing with knowledge of your
insurer’s policies, your state’s laws, and the particulars of the trial in
which you are interested has the best chance of success. A call from your
doctor to your insurance company’s Medical Director can also be very helpful.</span></div>
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</span><br />
<span style="font-family: arial;">To put a smile on your face see <a href="http://www.cancer-clinical-trials.com/p/clinical-trials-in-cartoons.html">Larry's latest cartoon.</a></span><br />
<span style="font-family: arial;">To learn more about clinical trials, take a look at <a href="http://tinyurl.com/cancer-clinical-trials-book">our book.</a></span><br />
<span style="font-family: arial;">
<img src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhAWYLVuUlu5Hq_Elg9pokI-Be5GFY8oe53iScn-8JSTfiAIDtmH6i7dl2al8n7es8vR4Jrb8RyXqdlAqt7geKEY8xbO2ZNy40uOc2nmpEwmUZCXPS2FRWvU4tlD8aTLWiV4kD8dX6S0Kg/s1600/WRITERS.jpg" height="75" width="100" /><br />
</span>
(c) 2012 Tom Beer and Larry AxmakerLarry Axmakerhttp://www.blogger.com/profile/03644176927295665033noreply@blogger.com0