Whistleblowers reveal FDA exacerbated Vioxx scandal
that the regulatory agency was "the single greatest obstacle to
doing anything effective" regarding Vioxx, adding that the FDA
could have prevented the deaths resulting from the drug's use.
FDA drug safety officer David Graham's comments were made during a roundtable meeting with whistleblowers, who were invited by the medical investigative journalist Jeanne Lenzer to share their accounts of practices in research that they believed were risking the public's health or safety.
The meeting included prominent members of the pharmaceutical and drug regulators, which over recent months has expressed deep concern over certain aspects and practices the industry uses to maximise its advantage.
In comments that echoed his now infamous testimony to the US Senate Finance Committee, Graham said that, "Nearly 60,000 people probably died from that drug. That's as many of our soldiers that were killed in the Vietnam war [who] died as a result of Vioxx use. And FDA had the opportunity, the responsibility, to stop that and didn't."
Vioxx (rofecoxib), used by millions worldwide to treat arthritis was withdrawn from the market last September after comprehensive clinical data confirmed long-established concerns that the treatment increased the risk of heart attacks and strokes.
Its withdrawal sent a powerful message regarding safety over similar drugs in the same class. Vioxx is a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID) primarily used to relieve signs and symptoms of arthritis, acute pain in adults, and painful menstrual cycles. Conventional NSAIDs include ibuprofen and naproxen.
Lenzer, whose account of the roundtable is published in the open access international medical journal PLoS Medicine, said "ties between drug regulators and industry may influence new drug approval."
"The race to approve new drugs without proper safety testing may be compromising the public's health," she stated.
Revelations made during this meeting is set to further dent the image of the pharmaceutical industry that has recently had to deal with devastating disclosures and is only now beginning to emerge after the aftermath.
Perhaps the most damaging issue that arose was the alleged "ties between drug regulators and industry that may influence new drug approval." Graham said at the roundtable that the FDA was in "a collaborative relationship" with industry, in which the FDA received money from drug companies through the Prescription Drug User Fee Act "to approve new drugs and approve them more quickly." A senior official at the FDA, said Graham, had allegedly told him "industry is our client."
"The pharma-FDA complex has to be dismantled," he said, "and the American people have to insist on that, otherwise we're going to have disasters like Vioxx that happen in the future."
The roundtable bought together some of the most high profile figures within the industry from a variety of different professional backgrounds. Four whistleblowers attended in person, and the anonymous industry scientist participated via speakerphone.
Many of the whistleblowers at the roundtable said they had experienced retaliation from their employers for raising concerns, but all had felt obligated to speak out about practices in research that they believe are risking the public's health or safety.
Lenzar spoke about the: "race to approve new drugs without proper safety testing that may be compromising the public's health." The research scientist, who was from a major pharmaceutical company, said that "drug companies will not conduct safety studies unless they have to - meaning basically that they're required by a regulator - and that rarely happens."
The scientist deemed the studies that form the basis for regulatory approval as "too small," conducted over too brief a period to properly assess safety. "There are 'blockbuster drugs' out there," said the scientist that "might be associated with tens of thousands of deaths a year," but this risk "would never be detected in studies of the kind that we routinely submit and are the basis for approval. These drugs are essentially out there now, unlabeled, unnoticed, all beneath the radar."
These claims make a mockery of the recent call by editors of eleven international medical journals, who amplified their call for the registration of drug trials in a medium that was publicly accessible before the first patient is enrolled.
These calls echo a statement made in September 2004, where members of the International Committee of Medical Journal Editors (ICMJE) published a joint editorial aimed at promoting registration of all clinical trials.
Lenzer's account captures some of the ways in which industry may influence not only which drugs get approved, but also which drugs get prescribed.
One of the roundtable whistleblowers was Allen Jones, a former investigator at the Pennsylvania Office of the Inspector General, who filed a civil rights lawsuit on November 22 2002 "to preserve my job and my right to speak out."
Previous investigations by Jones revealed state officials were allegedly accessing cash from an account in which pharmaceutical companies were paying money into. These officials "were given unrestricted educational grants that were deposited into an off-the-books account - unregistered, unmonitored, literally operated out of a drawer." The officials, he said, were responsible for writing guidelines for the treatment of patients in the state system and were receiving money from companies with a stake in these guidelines.
Kathleen Slattery-Moschkau, a former drug representative who wrote and directed the movie Side Effects, a fictionalised account of her experiences, focused her argument on the marketing tactics used by drug companies.
In particular, she described one particular method in which companies bought doctors' prescribing records so drug representatives knew "to the dime" what drugs doctors were prescribing and could tailor their marketing to them.
Lenzer concluded in her account that each of these whistleblowers, in very different ways had shone light on how the "synchrony" between the pharmaceutical industry and the medical enterprise may be compromising the integrity of American medicine.
"We should not have to rely on medical whistleblowers to alert us to these fault lines," she says. "If we are to restore objectivity to drug development, prescribing, and safety monitoring, we must be willing to examine and change all of the institutions that allow this synchrony to occur."
