under some of the rocks…

Posted on Thursday 14 August 2014

I started writing about these topics a few years ago because I was stunned by the deceptive presentation methods in clinical trial reporting. And then I discovered that if a trial didn’t come out like they wanted and couldn’t be doctored, they just didn’t publish it. The more I looked, the worse things got. I kept running across the term CRO, one that I’d never heard before, and asked a more knowledgeable colleague what it meant. Looking into that arena lead me to a whole new level of deception. It has been a disillusioning journey, I must admit. Back in the day, there weren’t so many resources for chasing things down: Carlat, Soulful Sepulcher, Healthcare Renewal. Now there are many more, thankfully. But Dr. Roy Poses blog at Healthcare Renewal remains the gold standard when it comes to the big picture. This take on the recent article by Carl Elliot in Matter is up to his usual level and worth a full read for its editorial perspective:
Healthcare Renewal
by Roy Poses
August 13, 2014

Dr Carl Elliott seems to be one of the few people willing to investigate how modern medical research may threaten vulnerable research subjects.  His book, White Coat, Black Hat, opened with a chapter on vulnerable "guinea pigs," people willing to be clinical research subjects for money.  Such people may be desperate for money, and further may be homeless, and have psychiatric problems, including psychosis or drug or alcohol problems.  Dr Elliott just wrote another important article on the plight of vulnerable research subjects…
In Carl Elliot’s article [The Best-Selling, Billion-Dollar Pills Tested on Homeless People], he talks about making a personal hegira into the Clinical Research Center world, and he actually visited South Coast Clinical Trials, home to The Clinical Trials Guru. I first ran across South Coast back in 2011 [the clinical research industry: the CRCs…] directed by a post on Soulful Sepulcher [still active on Twitter]. In my recent take on Carl’s articles [some system…, the illusion of evidence…], I posted one of South Coast‘s many videos of their research subjects. Here‘s another oldie from South Coast, their discussion about the case of Dan Markingson, Carl Elliot’s major focus. And speaking of University of Minnesota’s bioethicist Carl Elliot, here’s his recent blog about another old friend I was also introduced to by Soulful Sepulcher some time back [selling seroquel II: into the fray…]:
Fear and Loathing in Bioethics
by Carl Elliot
August 11, 2014

Illinois has suspended the medical license of Dr. Michael Reinstein, aka The Clozaril King.  Reinstein "received ‘illegal direct and indirect remuneration’ from the maker of generic clozapine; did not consider alternative treatments for his patients; and disregarded patients’ well-being because of potentially life-threatening side effects of the drug."  

In 2009, ProPublica and the Chicago Tribune detailed how he had prescribed more of the antipsychotic clozapine to patients in Medicaid’s Illinois program in 2007 than all doctors in the Medicaid programs of Texas, Florida and North Carolina combined. Autopsy and court records showed that, by 2009, at least three patients under Reinstein’s care had died of clozapine intoxication.
Dr. Michael Reinstein was even more than the Clozaril King, he was also the psychiatrist for a Clinical Research Center next door in Chicago. I ran across this bit of information trying to run down where the Lurasidone [Latuda®] trials were conducted by looking at Google™ Maps, Street View [see hiding uptown]. Uptown Research is a CRC like South Coast, only in Chicago rather than California. They were also involved in some of the Seroquel® clinical trials:


Charles Ornstein at ProPublica has long been on the trail of Dr. Michael Reinstein:
ProPublica
by Charles Ornstein
Aug 11, 2014

Illinois medical regulators have indefinitely suspended the medical license of psychiatrist Michael Reinstein, who prescribed more of the most powerful and riskiest antipsychotic drug clozapine than any other doctor in the country. The decision by Illinois’ Department of Financial and Professional Regulation, signed Friday, suspends Reinstein’s license for a minimum of three years, at which time he can apply to have it reinstated.

The state’s medical disciplinary board recommended the sanction in May after determining that Reinstein, 71, received "illegal direct and indirect remuneration" from the maker of generic clozapine; did not consider alternative treatments for his patients; and disregarded patients’ well-being because of potentially life-threatening side effects of the drug. Reinstein’s motion for a rehearing was denied Friday, making the matter public.

Clozapine is approved to treat patients who don’t respond to other medications. But it can have dangerous side effects, including seizures, inflammation of the heart muscle, and a drop in white blood cells. The drug is considered particularly dangerous for elderly patients…

In 2009, ProPublica and the Chicago Tribune detailed how he had prescribed more of the antipsychotic clozapine to patients in Medicaid’s Illinois program in 2007 than all doctors in the Medicaid programs of Texas, Florida and North Carolina combined. Autopsy and court records showed that, by 2009, at least three patients under Reinstein’s care had died of clozapine intoxication. At that time, Reinstein defended his prescription record, arguing that clozapine is effective and underprescribed.

Last year, as part of an investigation into Medicare’s failure to monitor problem prescribers, ProPublica reported that Reinstein prescribed even more clozapine in Medicare’s prescription drug program for seniors and the disabled. We found that the program continued to let him prescribe even after the U.S. Department of Justice accused him of fraud and Illinois’ Medicaid program suspended payments to him…

I came back Monday from a vacation trip with friends where I spent little time thinking about contemporary matters medical. When I got back Monday night, I was out of the rhythm of keeping up with the things I usually follow. What I always find when I’ve taken a break is that I feel anew the same kind of outrage I felt five or six years ago when I first began to understand how the pharmaceutical-academic psychiatry alliance had become so widely corrupting. Obviously it’s a much bigger problem than simply psychiatry, but it appears my specialty was especially vulnerable [and had some people in high places who dove in head first]. It always takes me a few days to recover my composure and get back into the state of play, rather than this just rant on and on about the myriad of absurdities like those mentioned above.

I remain awed by the tenacity of the people who have dogged this problem for years – people like Drs. Bernard Carroll and Bob Rubin, Jon Juriedini and Healthy Skepticism, David Healy and Rxisk, Stephany of Soulful Sepulcher, Danny Carlat, Dr. Poses of Healthcare Renewal, Ed Silverman of Pharmalot, Joe Friday at Pharmagossip, Carl Elliot of Fear and Loathing in Bioethics, Ben Goldacre of AllTrials, the volunteers of the Cochrane Collaboration – and the growing number of others who’ve taken up the task of shining spotlights into the dark corners of the medical industries. What’s missing, by my read, are strong stands by the various medical professional organizations and particularly their sponsored academic journals. Dr. Fiona Godlee of the British Medical Journal stands tall as an exception to the laissez-faire attitude of journal editorial staffs elsewhere.

On my trip, I returned to the Museum of Civil War Medicine in Frederick Maryland that I mentioned last Fall [in the museum…], this time with four other doctors and our wives – people we were stationed with in the early 1970s that we spend a week with every summer. In the Fall, I was impressed with the advances in medicine in the Civil War – triage, ambulances, hospitals, nursing care, anesthesia and early amputation to prevent gangrene. This time through, I found myself thinking about what was missing. About the only medication in the displayed pharmacy kits that would pass muster was opium. Everything else was either in the toxic poison or inert patent medicine category. Those were the days before Pasteur and Lister so antiseptic techniques were unknown, much less antibiotics. The real killers in the Civil War were the infectious diseases that swept through the camps in waves, killing many more than the enemy’s bullets. On the nearby battlefield at Antietam where 23,000 soldiers became military casualties in a single day, there was an unfinished stone with a small embedded brick cross among the cannons and heroic granite sculptures of soldiers. It marked the spot where Clara Barton [later founder of the American Red Cross] narrowly escaped a miniball that killed the fallen soldier she was tending to. The chief of nursing there was Dorthea Dix, the crusader for moral treatment of the mentally ill.

As we walked around the museum, I realized that among the ten of us seventy-somethings, there were any number of artificial joints, stents, lumbar fusions, early detected cancers with successful treatment, and I expect that the dopp kits back at our B&B held a number of pill bottles with medication that actually helped with something or another. I think I need periodic reminders of the advances and successes of modern medicine to counter the cloud that sometimes forms looking at the dark places under some of the rocks that dot the medical landscape…
  1.  
    Same Old Same Old
    August 17, 2014 | 10:15 AM
     
  2.  
    August 17, 2014 | 11:50 AM
     

    thank you, for keeping the light in the shadows …. :)

  3.  
    Amelie Perron
    August 18, 2014 | 2:24 PM
     

    Great post. A quick note though: her name was Dorothea Dix, not Dorthea. A remarkable woman indeed.

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