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.
But trust Peter Rost to find the wrinkle—Schering-Plough’s President dumped $28 million in stock before Vytorin controversy erupted.
So where is the SEC investigation (and for that matter, what about their investigation into similar activity at Wellcare)?
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 Angell et 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.
Of course we’ve had this little argument on THCB many times before.
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.
You can’t trust those Brits. I get a super exclusive on the Sermo-Pfizer deal and those damn Brits at the FT break the press embargo. So much for “honour” amongst journalists!
This is the latest version of Big Pharma’s experiment to figure out how to replace the incredibly inefficient way it researches, sells to and communicates with doctors. The very baby steps of starting to cut those detail forces are just starting to be taken, but while those empires slowly get dismantled over the coming decade(s), something needs to be put into its place. eDetailing via video has been a bust so far, and putting those hot cheerleaders into the doctor’s office is getting more and more expensive.
So the deal is that Pfizer (and of course soon other pharmas) will be able to put information into the social networking site. This has great opportunity and great peril for big Pharma. Of course there’s lots of information that they can contribute, and lots of contacts that they can make. But on the other hand, they are definitely losing control over the message.
Increased risk of death. No benefit. Higher costs for taxpayers. The ongoing Epo saga, whose latest chapter is being written on Capitol Hill, is a perfect example of why our health care outcomes are second-rate, while our health care costs are second to none.
This is a great bit of digging from Merrill, and it shows why FFS or in this case, Fee for drugs is just a bad way of paying for medical care. Do read it.
An innovative Ft. Worth consulting firm comprised of experienced oncology professionals, Oncology Metrics, has linked private oncology practices throughout the country in a collaborative, knowledge-sharing enterprise, called the Oncology Circle. The first round of information brought together 22 practices containing 167 medical oncologists. Combined, the practices treated almost 63,000 patients annually, had $600 million in revenues and spent $375 million on drugs.
In a separate but related effort, Oncology Metrics has established a new national data aggregation effort, The Oncology Metrics National Index (OMNI), which brings together data from practices using electronic medical records (EMRs), mapping the data in each EMR to a standard template. Then those data are aggregated and mined to produce different cancer care-related clinical measures associated with procedures and processes: e.g., the administration of erythropoietin (anemia drugs), hemoglobin (Hgb) testing, and patient staging. A primary goal is to create a data mine that can allow each practice to see how it compares to others, and how they might improve. But a secondary and also very important objective is the development of transparency information that can help rationalize the practices and costs that have dominated oncology.
This is a leading edge project that leverages the data that is newly available through EMRs, and that is indicative of the kind of progress that we can anticipate throughout health care in the next few years. Clearly a company to watch.