Harvard Researchers Subpoenaed

This is one to watch. We might all get to learn more about the Harvard-Industrial Complex.

The Times reports:

Federal prosecutors have issued a subpoena seeking information about the work and statements of three prominent Harvard researchers who have been the focus of a Congressional investigation into conflicts of interest in medicine.

The researchers -- Drs. Joseph Biederman, Thomas Spencer and Timothy E. Wilens -- are named in the subpoena, which was sent on Wednesday to Fletch Trammel, a lawyer who represents state attorneys general in lawsuits that claim makers of antipsychotic drugs defrauded state Medicaid programs by improperly marketing their medicines.

The three researchers have advocated increased use of antipsychotic medicines in children and have accepted lucrative consulting agreements from the drugs' makers. Senator Charles E. Grassley, an Iowa Republican investigating conflicts of interest in medicine, found that each of the researchers had failed to report much of his consulting income to Harvard. Mr. Grassley has also said that Dr. Biederman and Dr. Wilens might have violated federal and university research rules. The controversy led Dr. Biederman to suspend his work with the drug industry.

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I'm having difficulty even reading, much less posting about, the river of stories about pharma and device industries, FDA regs, conflicts of interest, and so on. But I'll take a stab here at spotlighting the main events and making some sense of where this is headed. For I don't think it's just…

After reading Orac's recent piece on COI @ JAMA, I'm wondering how they are handling this, and how much of these guys' research they published.

Is there language in the Medicare or Medicaid regulations prohibiting off-label use of medications? I've not been aware of this.

Research in children is very difficult. Parent's don't volunteer their kids for studies, and that's understandable.

When I started my training, there were two on-label meds: imipramine for bedwetting and Ritalin for ADHD. There are a few more now, but not many.

The recent indications granted by the FDA have been precise and rather wordy. For example, Risperdal is now indicated for children 10 and older with mania but not in combination with other meds, 13 and older for schizophrenia, and 5-16 for irritability associated with autism. So, strictly speaking, Medicaid kids with autism must go off Risperdal on their 17th birthday, unless they happen to be manic.

I see a lot of well poisoning - e.g., several papers have mentioned Biederman's quip that the job above full professor at Harvard is "God." Then there are those steamy emails from the Seroquel researcher alluding to bondage. I don't like it when my government plays this game.

I've no problem with fines and penalties if these guys didn't report their incomes appropriately. But I find it weird that Medicaid and Medicare get to take all their money back for all the prescriptions that were "off label." WTF?

And I find it weird that Lilly, AstraZeneca, Janssen, and the heart of American psychopharmacology are all in the gun sites at the same moment in time.

Ah, poor child psychiatry. It's a dying field. There are like, six in my state. You can count the academic research centers on one hand.

Grassley and Harkin will write the universal health care bill this year. They have a specific agenda involving the expansion of primary care to include naturopaths and chiropractors, and with supplements reimbursed by Medicare-Medicaid just like prescription drugs.

Hats off to 'em for the preemptive strike against the opposition voices. Pretty brilliant strategy politically.

Wow! David "I give new meaning to insane" Mabus has graced us with his presence! Now we can all learn how a 6 legged goat and Depeche Mode predicted 9/11!

Everyone listen closely now!
</snark>

By LanceR, JSG (not verified) on 03 Apr 2009 #permalink

Hopefully that will shed light on these types of cases because the state brings nothing good, because there are many people who have diabetes and are marginalized by the same doctor who benefit instead of helping ...

Chronic pain is very severe and this affects people's life, long known to people who suffered from a strange disease, were strong back pains, which were intense and not let them work, as was what they said were the doctor and he prescribed oxycodone for pain, but knew it was a very powerful medicine, and moreover, anxiolytics, and worry that they were doing things that previously did not like eating too much, smoking, etc.. and read in findrxonline that this drug is well and that we must be very careful with their use, and everything must be under medical prescription.

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Everyone is an atheist about all gods but their own. I just reject one more than you.

By LanceR, JSG (not verified) on 12 Apr 2009 #permalink

Science today has changed, I hope you used the right way, because there are medications such as vicodin, oxycodone, Lortab, etc, are anxiolytic and although much help to soothe the pain, can be double-edged weapon to control pain, so indicate in findrxonline to be confident that this discovery is beneficial to all.

I wonder what will happen to the drug companies that precipitated this. My prediction is nothing, since they're probably too big to fail.

Has this blog shut down or something? It's been three weeks since the last post.

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