Restoring Study 329: Letter to BMJ

When we set out to restore GSK’s misreported Study 329 of paroxetine for adolescent depression under the RIAT initiative, we had no idea of the magnitude of the task we were undertaking. After almost a year, we were relieved to finally complete a draft and submit it to the BMJ, who had earlier indicated an interest in publishing our restoration. But that was the beginning of another year of peer review that we believed went beyond enhancing our paper and became rather an interrogation of our honesty and integrity. Frankly, we were offended that our work was subject to such checks when papers submitted by pharmaceutical companies with fraud convictions are not.
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Lancet Editorial Points to “Trouble with Psychiatry Trials”

While clinical trials make up the “bedrock of evidence-based medicine” in other specialties, psychiatry faces a number of both ethical and scientific problems related to its use of randomized control trials. According to a new editorial in The Lancet Psychiatry, the field of psychiatry research has particular challenges with ethical issues in recruitment, inaccurate classification systems, and problematic placebo comparisons, and then, once the studies are finished, it often remains unclear what the “outcomes actually mean for people’s lives.”

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“BMJ Editor Fiona Godlee Takes on Corruption in Science”

In this video from CBC News, BMJ editor Fiona Godlee takes on “corruption of the scientific process.” "There will be commercial pressures, academic pressures, and to pretend otherwise is absurd. So we have to have many more mechanisms, much more skepticism, and much more willingness to challenge."

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“The Outcome of My Clinical Trial Is a Mystery”

Writing for the Atlantic, Emma Yasinski confesses that she was enrolled in a clinical trial for an invasive experimental surgery at seven years old but, as the results were never published, she may never know how well it actually worked.

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“6 Hospitalized, One of Them Brain-Dead, After Drug Trial in France”

Six men were hospitalized and one was pronounced brain dead after participating in a phase 1 clinical drug for a mood, anxiety, and motor dysfunction drug manufactured by Bial and administered by Biotrial. Carl Elliott, a bioethicist at the University of Minnesota, said investigators should look into questions like how much the men were paid and whether they properly consented to the trial. “Many Phase 1 trial volunteers are poor and unemployed, and they volunteer for trials like this because they are desperate for money,” he said. “This means they are easily exploited.”

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“Martyrs to Science? When Research Participants Die”

Neuroskeptic covers a short article by Susan Lederer that appeared in the American Medical Association Journal of Ethics discussing what happens when research participants die.

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$8 Million Awarded to Family Of Man Who Died in Risperdal Trial

A California jury ruled that Johnson & Johnson’s Janssen Pharmaceutical and a psychiatrist are responsible for the death of 25-year-old Leo Liu. During a clinical trial for Risperdal, Liu died of a heart injury that was “further complicated” by the drug and ignored by the study doctors. Janssen was found 70% responsible for Liu’s death and ordered to pay $5.6 million to the family.

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Bernie Sanders Opposes Califf for FDA Post Cites Industry Ties

Current presidential hopeful and longtime Vermont independent senator, Bernie Sanders, said that he will vote against Robert Califf’s nomination to lead the Food and Drug Administration (FDA). Sanders explained his opposition by citing Califf’s extensive ties to the pharmaceutical companies that he would be in charge of regulating.

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Nominee to Lead FDA Removed Name From Recent Publications

Sheila Kaplan for the Boston Globe reports that Dr. Robert Califf, the Obama administration's nominee to lead the Food and Drug Administration (FDA), has removed his name from a series of scientific papers that he recently coauthored.  The decision to remove his name, against publication ethics standards, has brought Califf under renewed criticism.

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“The Life of a Professional Guinea Pig”

In the Atlantic, Cari Romm describes “what it is like to earn a living as a research subject in clinical trials.”  “Phase 1 trials are almost always where the money is,” she writes, but they are “also the least regulated” and “companies aren’t legally required to register a trial with Clinicaltrials.gov.” “It seems to me like if you were considering signing up for one of these things, you would at least want to know the data that’s out there about [safety],” said Carl Elliott, an author for MIA and expert on the ethics of human subject research.

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“New Depression Meds Not Effective Generally, But Drug Companies Insist Otherwise: Study”

The International Business Times covers a new study showing “trials for new antidepressant medications may not be applicable to the population at large.” “The finding, published in the Mayo Clinic Proceedings, shows recent trials are less generalizable than the prior studies, as researchers excluded most depressed patients from drug company-sponsored treatment studies.”

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Are You Ready for Multiple Lawsuits By Victims of Psychiatric Misconduct?

Professor Leigh Turner of the University of Minnesota Center for Bioethics blasts the Board of Regents for ignoring psychiatric research abuse.
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As Lawyers and Bureaucrats Delay,
The Body Count Rises

It took over twenty years for the state medical board to sanction a Minnesota psychiatrist who was responsible for the deaths and injuries of 46 patients. Today, in the Markingson case, it looks as if history is repeating itself. How many patients die while bureaucrats delay?
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And That’s the News from the Department of Psychiatry

In the business of clinical trials, the most valuable commodities are the research subjects. Filling clinical trials is hard, and filling them quickly is even harder. That’s why in 2000 a clinical investigator told the HHS Office of the Inspector General that research sponsors were looking for three things from research sites: “No. 1—rapid enrollment. No. 2 — rapid enrollment. No. 3 — rapid enrollment.”
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The Road to Perdition

The recent research scandals out of the University of Minnesota’s Department of Psychiatry may be alarming, but they are not new. Back in the 1990s, when the university was working its way towards a crippling probation by the National Institutes of Health (for yet another episode of misconduct (this time in the Department of Surgery), the Department of Psychiatry hosted two spectacular cases of research wrongdoing, both of which resulted in faculty members being disqualified from conducting research by the FDA.
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Fact-Checking the General Counsel in the Markingson Case

Ever since critics began asking questions about the death of Dan Markinson in a clinical trial at the University of Minnesota, the General Counsel for the university, Mark Rotenberg, has responded with a uniform message: the case has already been investigated many times, and no wrongdoing has ever been found. That’s how Rotenberg responded to my article about the case in Mother Jones, and that’s how he responded last week to the news that the Board of Social Work had issued a “corrective action” to the study coordinator for the clinical trial in which Markingson died.
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The University of Minnesota was not Involved? Some Further Thoughts on the “Corrective Action” Against Jean Kenney in the Markingson Case

The suicide of Dan Markingson at the University of Minnesota has brought notoriety to the CAFÉ study and its site investigators, Stephen Olson and Charles Schulz. But the “corrective action” recently issued by the Minnesota Board of Social Work against the CAFÉ study coordinator, Jean Kenney, has raised another disturbing question.
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“Do We Have to Wait Until He Kills Himself or Someone Else Before Anyone Else Does Anything?”

In the “agreement for corrective action” against CAFE study coordinator Jean Kenney last week, the Board of Social Work cited Kenney’s failure to respond to “alarming voicemail messages” from family members of Dan Markingson. Presumably, the Board is referring to a message left by his mother, Mary Weiss, which warned, “Do we have to wait until he kills himself or someone else before anyone else does anything?” The failure of Kenney and Stephen Olson to take the warnings of Mary Weiss seriously has been one of the most disturbing aspects of this case. In a deposition for the lawsuit filed by Weiss, Kenney was questioned about her response. Here is an excerpt. (The initial questions come from Gale Pearson, an attorney for Mary Weiss.)

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“I Was Just Following Orders”: a Seroquel Suicide, a Study Coordinator, and a “Corrective Action”

Out here in Minnesota, where the snow is gently falling, many of us are hunched over our computers, puzzling over a document just posted by the state Board of Social Work. It concerns the death of Dan Markingson (or as the document calls him, “Client #1”). Markingson, of course, was a young man under a commitment order who was coerced into a profitable Seroquel marketing study at the University of Minnesota over the objections of his mother, and whose condition spiraled downward until he committed suicide.
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Study 329’s Authors: Should Those Who Live in Glass Houses Throw Stones?

For the past several years whenever a critical essay has come along examining the work of Irving Kirsch and his colleagues I have made an effort to examine the validity of the proposed arguments. Kirsch and his colleagues used the Freedom of Information Act to gain access to the unpublished trials of antidepressants and then pooled the clinical trial data – both published and unpublished ─ and analyzed it as a single data set. It is common for pharmaceutical companies to only publish those studies that find their products effective, and to withhold the negative studies, making it difficult to reach accurate conclusions by examining only the published data. Kirsch and his colleagues have reported that in the company sponsored clinical trials, the SSRIs only marginally outperform placebo, with the difference being statistically different but not clinically significant.
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When Medical Muckraking Fails

Everyone knows how muckraking is supposed to work.  An investigative reporter uncovers hidden wrongdoing; the public is outraged; and the authorities move quickly on behalf of justice and righteousness.  There can be failure at any of these points, of course.  …
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“Unfortunate experiments” in New Zealand and Minnesota

Carl Elliott writes on the discrepancy between New Zealand’s response to a research scandal – which lead to a national debate and dramatic reforms – and the silence following clinical trial scandals in the U.S.
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US Senator Raises Concerns About Possible Stock Manipulation by Vertex Executives

Senator Charles Grassley is upping the ante on the controversy surrounding the Vertex pharmaceutical executives who cashed in on overstated clinical trial data — see my blog from last week. According to The Boston Globe, which broke the Vertex story, …
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