In a story titled somewhat cryptically Medicare chief stands by anemia move (do they mean he’s trying to become anemic?) Reuters reports that CMS is not backing down from its decision to radically cut payments for anti-anemia drugs for chemotherapy patients. In English this means that Amgen’s Arenesp (& Epogen, though that’s not officially for cancer patients) and J&J’s Procit (which is Epogen re-marketed by J&J) are not going to recover their lost sales from last year. Those sales began to be lost when studies revealed that the fairly rampant use of those drugs was overuse, and also that they were causing some severe side-effects.
Of course for reasons that we all know (e.g. they have little to do with clinical endpoints and more to do with financial ones), community oncologists have flipped out. I do like the response from Dr. Barry Straube, the chief medical officer at CMS. He said:
Our staff looked at over 800 evidenced-based articles published in the literature," he said. "I doubt seriously whether most clinicians read all 800."
Of course the real impact of this was not on patients per se, but on Amgen’s stock price, which has not had the best of years. The little rally late last year was on hopes that CMS would change its mind. I’m afraid that that gravy train looks like it’s over.
I’m sure (well I’m not sure but I’ll cheerfully and casually postulate) to keep you all amused on a Friday) that there are many possible overlooked problems with Lipitor and the statins. I’ve heard of severe muscle pain, even amnesia. But then again most cardiologists and the medical establishment recommend statins very widely and the general medical opinion is that they’re under-used.
I’m reading an interesting book The Last Well Person by Nortin Hadler whom I had the pleasure of meeting at the FIDMD meeting a few weeks back. Nortin is not exactly modest(!) but he’s very amusing and has firm firm opinions. In the book he systematically goes through the randomized clinical trial evidence of the value of much heart treatment including angioplasty, heart bypass, and statins. And his analysis from the West of Scotland trial (which admittedly was using Pravachol not Lipitor) is that statin use made only marginal absolute improvements in heart attacks and essentially no difference in overall mortality.
But is Congress investigating whether the medical establishment has been lead astray or is leading us astray? No.
Just in case you needed to be reminded that the DEA is a refuge of evil scumbags and needs to be abolished, here’s another exhibit (from the good people at DRCNet):
Federal agents arrested Dr. Stephen Schneider, operator of the Schneider Medical Clinic, and his wife and business manager, Linda, on a 34-count indictment charging them with operating a "pill mill" at their clinic. The indictment charges that Schneider and his assistants "unlawfully" wrote prescriptions for narcotic pain relievers, that at least 56 of Schneiders’ patients died of drug overdoses between 2002 and 2007, and that Schneider and his assistants prescribed pain relievers "outside the course of usual medical practice and not for legitimate medical purpose."
Schering Plough is coming under multo criticism the last two days for sitting on data for up to a year that shows that the anti-cholesterol drug Zetia, when combined with Merk’s Zocor in the combo drug Vytorin, not only didn’t work but may have caused harm. Here’s the story in the NY Times and here’s the op-ed in the same paper saying:
It was still very disturbing to learn this week that a heavily promoted cholesterol-lowering drug had flunked a clinical trial of its effectiveness in reducing fatty deposits in arteries. The two companies that reap billions from the drug had been cynically sitting on the results for more than a year.
Our friend and colleague Amy Tenderich has a just excellent Diabetes Year in Review up at DiabetesMine. It covers Health 2.0 (of course) but also drugs devices, design, and the growth of people with diabetes as a social force.
Amy knows that she’ll always be the #1 blogger in my heart!
In 1796 Dr. Edward Jenner performed an experiment that today would have
got him expelled from his Medical Society, and maybe even landed them
in jail. He vaccinated a boy against smallpox by pricking his arms with
pus taken from the sores of a milkmaid with cowpox, a closely related
but milder disease. He based this audacious experiment on his astute
observation that milkmaids, who had been exposed to cowpox, never
contracted smallpox. Let’s not forget what smallpox meant in those
days—it meant an almost 100% chance of death. Could anybody have
guessed that this observation would become the first harbinger of the
field of Immunology?
It took over 200 years before another vaccine was created; in 1914 a
vaccine against whooping cough was introduced. But then, the pace
picked up: in 1928 a vaccine against diphtheria, in 1933 against
tetanus, and so on. Five years ago a vaccine against varicella, causing
chickenpox and shingles was approved. Last year a vaccine against human
papilloma virus (HPV) was introduced. This virus causes endometrial
(lining of the uterus) cancer, and immunization of prepubertal girls
should protect them for life. This is the first successful vaccine
Says here (“here” being a long mea culpa article by a psychiatrist and former agent of Wyeth in the NY Times) that some doctors get paid by drug companies to give talks to other doctors about drugs, and that not only do they use studies that make those drugs look better than others, but that if they start pointing out the flaws of their sponsors drugs in their talks, then the money dries up.
I guess repeating a point is OK. But it’s not as if John Abramson, Marcia Angellet al haven’t beaten this to death. Yup, we can’t trust doctors not to be both naive and greedy (as the NY Times correspondent points out).
But there are two counterpoints. First is the informal one from other doctors, such as the newsletter that the physician in question now puts out, debunking dodgy research. I think we’re going to see much more of this in the future.
The second unfortunately we’re going to have to wait for—that is purchasers getting serious about physicians’ use of certain drugs when it’s clearly not medically appropriate. And despite lots of clear evidence about that, we’re still waiting. Blaming the drug company for taking advantage is still pointing the finger in, mostly, the wrong direction.
This is a pretty good example of a smart consultant using his blog to explain something complex. David Williams at the Health Business Blog got an on the record interview from Genentech about Avastin and Lucentis. If you know the background story skip this and go to the Interview with Genentech about Avastin distribution changes.
If you haven’t been following at home here’s a quick synopsis (and I’m in a rush and doing this from memory so I hope I get it right—please comment if you know more!).
THCB frequently spotlights Health 2.0 startups that are using Web 2.0 technology in new and innovative ways to solve healthcare challenges. Today we feature Erick and Linda Von Schweber, the developers of a new web-based system that allows consumers to better manage their drug regimens, allowing users to understand the trade offs involved with different drugs and reduce the odds of a potentially serious interaction. Look for more profiles of up and coming Health 2.0 startups and posts by Health 2.0 developers and entrepreneurs in the weeks to come.
Americans are worried; millions visit web sites multiple times each month looking for information on drug side effects, interactions and efficacy, but they say their needs are not being met by the simplistic data they find. This community-in-the-making is not paranoid; adverse drug effects (ADEs) are the 3rd leading cause of death in the US, killing 218,000 people a year, yet 150,000 of those deaths are deemed avoidable if only available knowledge could be identified and effectively applied.The barrier is complexity: the typical senior, on a regimen of eight drugs, can have as many as 40 trillion alternate regimens to choose from that vary widely on ADEs, efficacy and cost. Even the typical baby boomer, on a regimen of four to six drugs, faces a trade space of millions of choices. The only recourse is reading drug information sheets and using a drug interaction checker. But these only flag problems; they don’t offer solutions.