Jan 31, 2016

A letter from Senator Wyden to drug giant Gilead



We’ve posted several articles/editorials about high and seemingly eternally rising drug costs. Doctors, patients, and more recently, the U.S. Senate has weighed in. Will any of this make a difference?

In December, the U.S. Senate Finance Committee released a study showing the drug company Gilead didn’t consider affordability to patients when setting the price of a new Hepatitis C medication at $1,000 a pill. This kind of cost is not uncommon.

In a rather long open letter to drug manufacturer Gilead, Senate Finance Committee Chairman Senator Ron Wyden and Member Senator Charles Grassle ask a long series of questions about the drug, drug development, drug pricing, marketing costs, conflicts of interest, and much more.

Although this study focused on a single drug, the concern covers the spectrum of new drugs across the drug industry. The letter doesn’t offer solutions but asked for openness in price setting and ways to manage patient access to the new super-expensive drugs. It is a plea for transparency in the entire drug creation process. Who does what, who knows what, who gets paid for what, etc.

We ask you to click on the open letter link to see all the questions, comments, and requests.

 


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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

Dec 23, 2015

A Modest/Radical Proposal


Are you paying more for effective drugs and less for less effective drugs? Probably not…
 
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.
Peter B. Bach, a Director at Memorial Sloan Kettering Cancer Center, recently published an article in the Harvard Business Review proposing a new way to define drug pricing. We suggest you read the whole article.

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?

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.

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. 

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.

This is something to think about. It may be just fantasy. Watch for future research and articles about “paying for value.”



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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

Nov 7, 2015

Clinical Trials, Big Pharma, the FDA, and Expen$ive Drugs


...turns out this is not always a great combination for patients
 
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.

In a new book, Ending Medical Reversal: Improving Outcomes and Saving Lives, 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. Dr. Prasad is an Associate Professor of Medicine at OHSU.

Here are some excerpts from Dr. Prasad’s book in his own words:
"Cancer drugs are outrageously expensive; but they are worth every penny, right?
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.
Recently, we heard that profiteers are raising the price of old, established medicines. For many Americans, Turing pharmaceutical and Martin Shkreli have become four letter words.
But the problem of inappropriate prices is not just a few exceptional cases; it is the norm in cancer medicine.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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."
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.


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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

Oct 25, 2015

The World’s Largest Cancer Clinical Trial


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.


Clinical trials on the cheap
The BBC 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 Add-Aspirin Trial

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. 

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. 

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. 

Aspirin has several documented side effects—as do all drugs‑‑ and would not be appropriate for everyone.

Keep an eye on this study. Not all clinical studies have a good outcome but, if successful, this one could be a ‘game changer.’


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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

Sep 28, 2015

Cancer Treatment Drugs Approved in 2014 and 2015 by the FDA

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 CenterWatch. Never heard of of them? Check them out, talk to your oncologist...

 Drugs Approved in 2015

Farydak (panobinostat); Novartis; For the treatment of multiple myeloma, Approved February 2015
Ibrance (palbociclib); Pfizer; For the treatment of ER-positive, HER2-negative breast cancer, Approved February 2015
Lenvima (lenvatinib); Eisai; For the treatment of thyroid cancer, Approved February 2015
Lonsurf (trifluridine and tipiracil); Taiho Oncology; For the treatment of metastatic colorectal cancer , Approved September 2015
Odomzo (sonidegib); Novartis; For the treatment of locally advanced basal cell carcinoma, July 2015
Opdivo (nivolumab); Bristol-Myers Squibb; For the treatment of metastatic squamous non-small cell lung cancer, Approved March 2015
Unituxin (dinutuximab); United Therapeutics; For the treatment of pediatrics with high-risk neuroblastoma, Approved March 2015
Varubi (rolapitant); Tesaro; For the prevention of delayed nausea and vomiting associated with chemotherapay, Approved September 2015
Drugs Approved in 2014
Akynzeo (netupitant and palonosetron); Helsinn; For the prevention of chemotherapy-induced nausea and vomiting, Approved October 2014
Beleodaq (belinostat); Spectrum Pharmaceuticals; For the treatment of relapsed or refractory peripheral T-cell lymphoma, Approved July 2014
Blincyto (blinatumomab); Amgen; For the treatment of Philadelphia chromosome-negative relapsed /refractory B cell precursor acute lymphoblastic leukemia, Approved December 2014
Cyramza (ramucirumab); Eli Lilly; For the treatment of gastric cancer, Approved April 2014
Imbruvica (ibrutinib); Pharmacyclics; For the treatment of chronic lymphocytic leukemia, Approved February 2014
Keytruda (pembrolizumab); Merck; For the treatment of unresectable or metastatic melanoma, Approved September 2014
Lynparza (olaparib); AstraZeneca; For the treatment of previously treated BRCA mutated advanced ovarian cancer, Approved December 2014
Opdivo (nivolumab); Bristol-Myers Squibb; For the treatment of unresectable or metastatic melanoma, Approved December 2014
Zydelig (idelalisib); Gilead; For the treatment of relapsed CLL, follicular B-cell NHL and small lymphocytic lymphoma, Approved July 2014
Zykadia (ceritinib); Novartis; For the treatment of ALK+ metastatic non-small cell lung cancer, Approved April 2014


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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

Sep 7, 2015

ASCO 2015 Prostate Cancer Updates from a Roundtable of Experts

What'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.
Prostate cancer patients and cancer patients in general will find some hopeful news in this discussion.






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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

Aug 25, 2015

Cancer Clinical Trials and the Elderly—an Unlikely Combination


Did you know?
 

Q         What age group is most likely to have Cancer?

A         People older than 65. They represent 13% of the population and more than 60% of all those with cancer.

Q         Who is most likely to die of cancer?
A         Seniors. About 80% of all cancer deaths occur in those older than 65.

Q         What age group is least likely to be represented in cancer clinical trials?
A         Seniors. 

Q         Can seniors respond to cancer medications in a different way than younger patients? (For example, having more toxic side effects.)
A         Yes

Q         So, WHY are seniors with cancer not included more in clinical trials?
A         It’s a long story……

Improving the research base for treating older adults with cancer was a focus of the 2015 ASCO conference. An expert panel presented the problem and possible solutions. The Journal of Clinical Oncology reprinted the complete report and recommendations.

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. 

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.

Many oncologists, such as Stuart Lichtman, MD, 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.

ASCO makes five recommendations to improve evidence generation in the 65+ population:

(1) Use clinical trials to improve the evidence base for treating older adults (older than 65) with cancer,

(2) Leverage research designs and infrastructure for generating evidence on older adults with cancer (change trial requirements to fit older patients),

(3) Increase US Food and Drug Administration authority to incentivize and require research involving older adults with cancer,

(4) Increase clinicians' recruitment of older adults with cancer to clinical trials (educate doctors to recommend older patients for trials), and

(5) Use journal policies to improve researchers' reporting on the age distribution and health risk profiles of research participants.

Doctors currently have no choice but to use results from clinical trials conducted with people in their 50s to treat people in their 80s.

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.

Click on the links in this article for a more comprehensive discussion of this issue.
 


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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