May 25, 2012

Cancer Drug Side effects: Are you getting the whole story?

In a word (or two), maybe yes and maybe no.  Lists of side effects are easy to find.  Every drug has them.  These lists may be so long that they become almost meaningless.  As you leaf through these listing, several questions arise: 
1)    Is the list complete? Are there any side effects missing that I need to know about?
2)    Are all these side effects really caused by the drug?
3)    How do I know which of these side effects may happen to me?

How are side effect reported
We will tackle the first two questions, the third deserves its own blog post.  Researchers who study new cancer drugs are the first to report side effects.  Side effects can also be reported to the FDA after a drug is approved and regularly prescribed. Researchers report every adverse event that happens to their patients who are participating in a clinical trial.  Adverse events are reported together with their grade and “relationship to treatment.”  The grade is a measure of severity and for every imaginable adverse event, there is a table that describes what is mild (grade 1), moderate (grade 2), severe (grade 3), and life threatening (grade 4).  Clinic notes in research centers are filled with these mysterious grades whenever anything untoward happens. 

The relationship to treatment is determined by the research physician’s best judgment about whether the adverse event was caused by the drug or not.  There are shades of grey here:  related, probably, possibly, unlikely, and not related.  The decision is basically a judgment call, an educated guess.  Sometimes it’s obvious: you are feeling great and get the flu along with your entire family.  Pretty unlikely the drug had anything to do with it.  Often it is not so obvious.  People with cancer may also have other medical conditions and take many different drugs.  The illness itself takes a toll. When something untoward happens, there are many possible causes. 

With all this reporting, how could side effects go unnoticed?
Rare side effects can, of course, go unnoticed if they didn’t happen during the study.  Sometimes, the source you are relying on (i.e. research paper) listed only a subset of the

May 20, 2012

Answers to questions you always wanted ask - an interview with Dr. Barken

Dr. Israel Barken runs a wonderful site called Ask Dr. Barken.  He was kind enough to interview Dr. Beer about clinical trials.  This was an interview that asked the questions you would want to ask.  Unlike some of our other videos...this one is not packed with technical terms and "medicalese" language.  We hope you enjoy this interview.  The original is available on Dr. Barken's site.

To put a smile on your face see Larry's latest cartoon.

To learn more about clinical trials, take a look at our book.
(c) 2012 Tom Beer and Larry Axmaker

May 16, 2012

What do you think? Your turn to tell us!

We've been sharing all kinds of posts about clinical trials:  tips and focused information, perspectives and experiences, updates on recent advances and research directions, and videos of lectures with too many technical terms.

Now it's your turn.  We want to hear from you.  Using the comment fields below, please tell us what you think about the blog or about the topics we have discussed.  Ask us a question about clinical trials.  It's your turn to tell us what you think and what you want to hear about.

Let's start a conversation.

To put a smile on your face see Larry's latest cartoon.

To learn more about clinical trials, take a look at our book.
(c) 2012 Tom Beer and Larry Axmaker

May 14, 2012

Cancer Clinical Trials: How to get the new treatment

The most promising new treatments are tested in randomized trials, also known as phase III trials.  Usually a coin flip‑‑more likely a computerized equivalent‑‑decides whether each participant gets the new treatment or the current standard.  Since the new treatment wouldn’t get this far in research if it were not promising, it is not surprising that many people want to get the new treatment and not the old one.  Is there a way to do that?
No there isn’t at the beginning, and it is good to remember that when a randomized trial starts, we don’t know if the new treatment will really be better than the old. We all hope that it will, but history teaches us that some will and some will not.
There are four ways, however, that clinical trial participants may be able to get access to the new treatment even after a coin flip assigns them to the standard treatment:

  • Some randomized studies allow a crossover. This is a situation in which participants receiving a randomized treatment can later receive the treatment that was given to the other group of patients in the study.
  • If the new treatment turns out to be better while the study is under way, the trial is often stopped and the new treatment may be made available to all the study participants who did not receive it in the first place.
  • Once a study is completed and the new treatment is proven better, some companies offer a Compassionate Use Protocol, Early Access Program that makes the drug available on a limited basis until the drug gains FDA approval.  These are often available at the research centers that carried out the phase III study.
  • When a new drug is clearly a winner, FDA approval can come quickly (despite the commonly held belief that it takes a long time).  The FDA has approved drugs within several months of study results showing a compelling benefit to cancer patients.
While there are no “tricks” one can use to assure being assigned to one treatment group or another, there are a number of ways to eventually get access to a new cancer drug regardless of what the coin flip decides for us in the first place.  This is particularly true if the new treatment is confirmed to be a real improvement for cancer patients.

To learn more about clinical trials, take a look at our book.
To put a smile on your face see Larry's latest cartoon

(c) 2012 Tom Beer and Larry Axmaker

May 9, 2012

Video: Latest Developments in Advanced Prostate Cancer Treatment with Dr. Beer

A comprehensive discussion on all the principal current treatments and the most promising emerging drugs for advanced prostate cancer.  In this talk, we discuss hormonal agents including abiraterone and MDV-3100, chemotherapy drugs including docetaxel and cabazitaxel, immunologic therapy with sipuleucel-T, biologic therapy with XL-184, and bone targeted therapy with alpharadin.  We then put it altogether to offer a vision for the treatment paradigm of the near future.

For those of you that watched the previously posted talk, this one is a bit more inclusive and comprehensive.  It is a different program that was put together with the team at Medscape.

To see the entire program and slides, you will need to go the Medscape website.  You will likely need to sign up to be a member of Medscape to get full access to these materials.  There is no cost to doing this.

To learn more about clinical trials, take a look at our book.
To put a smile on your face see Larry's latest cartoon.

(c) 2012 Tom Beer and Larry Axmaker

May 5, 2012

Our book is on sale now...finally!

After a year of writing and re-writing and months of editing, refining, correcting, and reviews, and more, starts shipping our book May 7.

We are thrilled to see it come out.  We will of course continue to blog about clinical trials.  For those interested in a more in-in depth discussion of the topic and a more comprehensive resource, we hope the book will fit the bill.  If you are so inclined, order the book below:

(c) 2012 Tom Beer and Larry Axmaker

May 2, 2012

Thank you Women of Teal

Ovarian Cancer survivors, like survivors of many cancers, are resilient, tough, helpful, and strong in community with one another.  We are honored to have an ovarian cancer survivor's blog feature us, our blog, and our upcoming book on their pages.  

Check out a great post at the Women of Teal Blog

To put a smile on your face see Larry's latest cartoon

(c) 2012 Tom Beer and Larry Axmaker