pierrekory | One of the pharmaceutical executives directly involved in obtaining the approval for the original SSRI antidepressant, Prozac, developed a great deal of guilt for what he was complicit in once a large number of SSRI-linked deaths occurred. John Virapen, along with Peter Rost are the only pharmaceutical executives I know of who have become whistleblowers and shared the intimate details of how these companies actually operate. Although the events Virapen alleged seem hard to believe, other whistleblowers have also made similar observations to Virapen (the accounts of the Pfizer whistleblowers can be found in this article and this article).
John Virapen chronicled the events in which he was complicit in “Side Effects: Death—Confessions of a Pharma Insider.”
These included outrageous acts of bribery to get his drugs approved,
and photographing physicians with prostitutes provided by Eli Lilly so
that they could be blackmailed into serving Eli Lilly. For those
interested, this is a brief talk that Virapen gave about his
experiences. I greatly appreciate the fact he used candid language
rather than euphemisms like almost everyone else does:
At the start of the saga, Lilly was in dire financial straits and the company’s survival hinged on the approval of Prozac. Prozac had initially been proposed as a treatment for weight loss (as this side effect of Prozac had been observed in treatment subjects), but Lilly subsequently concluded it would be easier to get approval for treating depression and then get a post-marketing approval for the treatment of weight loss.
As Prozac took off, it became clear that depression was a much better market, and the obesity aspect was forgotten. Lilly then used a common industry tactic and worked tirelessly to expand the definition of depression so that everyone could become eligible for the drug and aggressively marketed this need for happiness to the public, before long, transforming depression from a rare to a common condition. For those wishing to learn more, Peter Gøtzsche has extensively documented how this fraud transpired and both this brief documentary and this article show how depression became popularized in Japan so that treatments for it could be sold.
Unfortunately, while the marketing machine had no difficulties creating a demand for Prozac, the initial data made it abundantly clear that the first SSRI, Prozac, was dangerous and ineffective. Lilly settled on the strategy of obtaining regulatory approval in Sweden, and using this approval as a precedent to obtain approval in other countries. Virapen was assigned to this task and told by his superiors that if he failed, his career was over. Virapen, unfortunately, discovered that whenever he provided Lilly’s clinical trial data to experts, they had trouble believing he was actually seeking regulatory approval, as Prozac’s trial data was just that bad.
Sweden (following their regulatory procedures) elected to allow an outside independent expert to make the final determination on whether Prozac should be approved or not. The identity of this expert witness was concealed, but Virapen was able to determine that it was Anders Forsman, a forensic psychiatrist and member of the legal council on the Swedish National Board of Health. After meeting with Virapen, Forsman proposed an untraceable bribe. Then, upon receiving payment, wrote a glowing letter in support of Prozac, fully reversing his position on Prozac (he had ridiculed it two weeks before) and guided Virapen through re-writing the trial to conceal the 5 attempted (4 of which were successful) SSRI suicides in Lilly’s trial.
Forsman’s expert opinion resulted in Prozac being partially approved and formally priced for reinbursement in Sweden, which was used as a precedent to market it around the world at that same lucrative price. Virapen noted that during this time, German drug regulators who had clearly and unambiguously stated that Prozac was “totally unsuitable for the treatment of depression” suddenly reversed their position, leading Virapen to suspect that similar under-the-table activity must have occurred in Germany. David Healey, a doctor and director of the North Wales School of psychological medicine, likewise concluded that the German approval was due to “unorthodox lobbying methods exercised on independent members of the regulatory authorities.”
Not long after saving Eli Lilly, Virapen was fired. Virapen believes he was fired because he was a man of color in an otherwise Caucasian company (he was told this by his supervisor). Gøtzsche, a leading expert in pharmaceutical research fraud and meta-analyses, on the other hand, attributed this to typical organized crime tactics where Lilly sought to conceal their illegal activity by firing Virapen and his two assistants to bribe Forsman (because immediately afterwards, none of them were permitted to access their offices, and thus could not obtain any of the files that proved that this bribery occurred). Fortunately, as happened with Peter Rost, this unjust firing eventually motivated Virapen to become an invaluable whistleblower.
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