The US Food and Drug Administration (FDA) was “the single greatest obstacle to doing anything effective” about Vioxx, said FDA drug safety officer David Graham at an unprecedented roundtable of medical whistleblowers sponsored by the Public Library of Science (PLoS) and the Government Accountability Project.
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.”
Graham was one of five high profile medical whistleblowers invited by the medical investigative journalist Jeanne Lenzer to meet together in Washington DC on May 15th 2005 to share their accounts of practices in medicine and medical research that they believe are risking the public’s health or safety. Lenzer’s account of the roundtable, in which she outlines the lessons we can learn from these whistleblowers, is published in the open access international medical journal PLoS Medicine. One of the lessons, says Lenzer, is that “ties between drug regulators and industry may influence new drug approval.” Graham said at the roundtable that the FDA was in “a collaborative relationship” with industry, and that the FDA gets 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 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.”
Another lesson, says Lenzer, is that “the race to approve new drugs without proper safety testing may be compromising the public’s health.” A research scientist from a major pharmaceutical company, who participated in the roundtable by speakerphone to protect anonymity, 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 industry researcher explained that the studies that are the basis for regulatory approval are too small and are 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.”
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.”
Jones explained that he had investigated an account into which pharmaceutical companies were paying money that was being accessed by state officials. 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.
The marketing tactics used by drug companies came under scrutiny at the roundtable. Kathleen Slattery-Moschkau, a former drug representative who wrote and directed the movie Side Effects, a fictionalized account of her experiences, explained how 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 concludes in her account that each of these whistleblowers, in very different ways – from making a satiric film to speaking out in Congress – has 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.”
In a related editorial, the PLoS Medicine editors explain why PLoS sponsored the roundtable and why they published Lenzer’s account: “Lenzer’s report will, we hope, spark discussion and debate about how American medicine – clinicians, researchers, regulatory agencies, and medical journals – can disentangle itself from the influence of the pharmaceutical industry.”