Wednesday, February 8, 2023

Tag: Restoring Study 329

The Whistleblower and Penn: A Final Accounting of Study 352

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After 18 years, the full story of the scientific corruption in a study of paroxetine for bipolar disorder, and the psychiatrist who blew the whistle.

Researchers Expose Pharmaceutical Industry Misconduct and Corruption

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Corruption of pharmaceutical industry sponsored clinical trials identified as a “major obstacle” facing evidence-based medicine.

Mickey Nardo: Tangled up in Life

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Mickey Nardo died yesterday. Here is a brief account of his career, chiseled out of him for the Restoring Study 329 site. What strikes me most is his interest in the tangles people end up in. This certainly is a theme that ran through his blog.

Study 329 Taper Phase

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Most doctors still affect surprise at the idea SSRIs might come with withdrawal problems. Regulators knew very clearly since 2002 about the problems, but have decided to leave any communication of these issues in company hands.

Study 329 Continuation Phase

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All the fuss about Study 329 centers on its 8-week acute phase. But this study had a 24-week Continuation Phase that has never been published. Until Now.

Restoring Study 329: Letter to BMJ

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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.

Is Motivation Worth More Than Expertise?

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The strongest evidence we have as to whether a drug causes a problem does not come from RCTs or any other controlled study but rather from good clinical accounts. Even if RCTs were done by angels, so there was no hiding, no miscoding, nothing untoward, RCTs can still hide adverse events. The onus is on large and powerful corporations who have a lot of resources to pinpoint the populations where the benefit is likely to exceed the risk, if they want to continue to make money out of vulnerable people.

The Ghost of Research Future

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Two facts about Robert Califf are beyond question. He is an expert on clinical trials, who is already seen as a leading architect of the future of medical research. And as the New York Times put it, he has “deeper ties to the pharmaceutical industry than any FDA commissioner in recent memory”. A lot of senior figures in medicine support Califf in spite of his ties to Pharma. The guy is just so bright, and understands the nuts and bolts of drug research so well! Surely a person like this is more useful than some outsider who offers only a squeaky-clean resume, they argue.

Study 329: Big Risk

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Study 329 seems to fit the classic picture: It has Big Pharma ghostwriting articles, hiding data, corrupting the scientific process and leaving a trail of death, disability and grieving relatives in its wake. But is it at fault alone? Both Big Pharma and Big Risk (the insurance industry) were once our allies in keeping our hopes alive – in keeping our children alive and well. They are now a threat. And of the two – Big Risk is the bigger threat.

Study 329: Psychiatry’s Thalidomide Moment, Part 2

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Nobody has retracted or apologized for a study that was an academic disgrace—but a marketing coup for GSK—which may well have caused untold numbers of deaths, suicide attempts and irreversible anguish to myriad families. Can we stand idly by when we’re told that it “accurately reflects the honestly-held views of the clinical investigator authors who do not agree that the article is false, fraudulent or misleading.”? What is the current market value of the honestly-held views of people who tell lies?

Study 329: 50 Shades of Gray

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Access to data is more important than access to information about conflicts of interest. It is only when there is access to the data that we can see if interests are conflicting and take that into account. Problems don’t get solved unless someone is motivated for some reason. We need the bias that pharmaceutical companies bring to bear in their defense of a product, along with the bias of those who might have been injured by a treatment. Both of these biases can distort the picture but it’s when people with differing points of view agree on what is right in front of their noses that we can begin to have some confidence about what we have.

Study 329: Conflicts of Interest

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The BMJ states that it takes on average eight weeks from submission of an article to publication. The review process for Restoring Study 329 took a year, with a three-month review process involving six reviewers to begin with, and then a further four reviews in a four-month process, leading to a provisional acceptance in March that was withdrawn.