September 6th, 2011 by BobDoherty in Health Policy, Opinion
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Follow the money.
Earlier this week, I blogged about the growing economic relationships and even mutual dependency between medical device manufactures and physicians, citing a pre-emptive strike against an Institute of Medicine report that recommended closer regulation of medical devices before and after they enter the market. Such ties, though, are only one part of a broader medical-industrial complex that has enormous impact on public policy in the United States.
A 2009 White Paper by the Seton Hall’s Center for Health & Pharmaceutical Law & Policy reported that “ drug and medical device companies fund up to 80% to 90% of all clinical trials; in 2005, and that by 2004, three-quarters of all of the clinical trials paid for by industry were in private physician practices or for-profit research centers.” The paper’s authors argue that such trials “create potential conflicts of interest that possibly jeopardize the rights and well-being of research participants as well as the integrity of research results” and that “the goal for public policy should be to structure physician-investigator payment to achieve financial neutrality between treatment and research.”
A recent web posting by a medical billing company unabashedly crows about the extra income doctors can make from clinical trials. Read more »
*This blog post was originally published at The ACP Advocate Blog by Bob Doherty*
September 2nd, 2011 by RyanDuBosar in Research
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Severe shortages for life-saving medications have driven a “gray market” in the wholesale drug supply industry, a watchdog group reports.
And the mark-up on gray market drugs is a budget-buster, reports the Institute for Safe Medication Practices, a Philadelphia-based nonprofit organization devoted entirely to medication error prevention and safe medication use. Purchasing agents and pharmacists at 549 hospitals responded to a survey on gray market activities associated with drug shortages.
The report includes chilling anecdotes from the respondents about pressure from physicians and administrators to ensure drugs are available, and drastic price gouging from the gray market suppliers. Price mark-ups of 10 times or more than the contract price were reported by about a third of respondents from critical access hospitals and community hospitals, and more than half of university hospitals. Examples include a box of calcium gluconate that cost $750 instead of the contract price of $50 (1,400% mark-up), and a supply of propofol that cost $25,000 instead of $1,500 (1,567% mark-up). Oh, and there’s exorbitant shipping and handling fees, too. Read more »
*This blog post was originally published at ACP Hospitalist*
July 21st, 2011 by Glenn Laffel, M.D., Ph.D. in News, Opinion
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I thought I read the final chapter in the tale of Pfizer’s shady marketing practices for Neurontin years ago. Sadly, there’s at least one more chapter to go.
Recall that in 2008, leaked documents from a US District Court revealed that Pfizer had covered-up the results of a clinical trial which showed the drug didn’t work for chronic nerve pain, even as it promoted off-label use of the anti-seizure drug for that purpose. The next year, it was revealed that Parke-Davis (now a subsidiary of Pfizer) took advantage of lax disclosure policies by certain medical journals to publish 13 articles promoting off-label use of Neurontin that were ghostwritten and funded by the company without disclosing such arrangements.
Now, it has come to light that Parke Davis’ marketing department sponsored a Seeding Trial of Neurontin back in the day—that is, a trial portrayed deceptively as a patient study but whose real aim was to encourage prescribers to use the drug.
The trial was STEPS, the ‘Study of Neurontin: Titrate to Effect, Profile of Safety’ trial. More than 772 physician ‘investigators’ and 2800 patients participated in STEPS.
The stated objective of STEPS was to study the safety, efficacy and tolerability of Neurontin. However, after reviewing documents compiled for a pair of lawsuits against Pfizer and its subsidiaries, Joseph Ross and colleagues concluded that the actual objective was to increase prescribing rates by ‘investigators’ in the study. Neither the ‘investigators’ nor their patients were informed about the real purpose of STEPS.
The trial worked, from Parke-Davis’ point of view. Read more »
*This blog post was originally published at Pizaazz*
July 9th, 2011 by admin in Opinion
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The medical app industry is a big business, but the apps are no longer the product – the physicians, nurses, and other healthcare providers who use them are. In the first part of this series, we examined some of the financial forces driving the medical app industry. Our focus then was Epocrates, the veritable founder of the industry. As is clearly stated in their recent SEC statement, Epocrates primary revenue stream has become the pharmaceutical industry and as such a key goal has become to further grow their user base by enhancing their free offerings.
Now, one might be tempted to say that this is just one company or even that it is just limited to free apps. An expected counter-example would be Skyscape, which probably has the largest cache of apps of any developer and nearly all for fee. As a private company, there isn’t much financial data available nor is the website particularly forthcoming, but it does appear that the company has been enjoying some success. A deeper look however suggests they in fact have more in common with Epocrates than you may think. Read more »
*This blog post was originally published at iMedicalApps*
July 8th, 2011 by AnneHansonMD in Opinion
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In Dinah’s post “The Chapter I Wish We Had Written” an anonymous commenter wrote about his problems finding an expert witness for his or her employment discrimination case (since I don’t know if Anonymous is male or female I’m going to use a standard male pronoun in this post—apologies if I got this wrong). Anonymous asked his doctor to help with the case, but he refused. He explained to Anonymous that he would be a biased witness and Anonymous also understood that the doctor’s involvement might affect the therapeutic relationship. Anonymous’s doctor gave her a number of referrals to forensic psychiatrists, but since he was not working with an attorney no expert would take the case. Anonymous was understandably frustrated by this situation.
I wanted to write about this because this situation comes up fairly often and I get calls from friends, colleagues and former students asking how to handle it. I’ve already written about what to do when you get served with a subpoena in my post “When Lawyers Call.”
First of all, I think Anonymous’s doctor was particularly astute to recognize the dilemma that arises when trying to help patients in situations like this. Read more »
*This blog post was originally published at Shrink Rap*
