Good Guys & Bad Guys
Left Field by Patricia Nell Warren
When Commercial Interests Cloud AIDS Research, Who Wins & Who Loses?
The AIDS establishment see themselves as the good guys. And they see “denialists” as the bad guys. According to establishment defender Nicoli Nattrass in a recent issue of The Scientist, “denialism” even includes “the conspiratorial argument that…HIV science has been corrupted by commercial interests.”
So corruption is just a conspiracy fantasy? Hardly. In the decade-plus that I’ve been writing this column, “corruption by commercial interests” has surged as science’s number-one real-life problem. Many observers point to the 1980 Bayh-Dole Act as one factor—it allowed university researchers to start patenting and profiting from their work. The AIDS epidemic came along just in time for its scientists to ride that new wave of money. Today there are still some people with scientific integrity and humanitarian passion who labor in the vineyards out there. In my opinion, these are the real good guys. Those who skew the science for gain are the bad guys.
The science world insisted that it could police its own through rigorous peer review. But big business, big academia, and big government found ways of getting around the self-policing. It wasn’t long before major publishers started releasing investigative books that exposed the growing politics, greed, and chilling disregard for public safety behind research and marketing in some areas. Example: Thomas J. Moore’s Deadly Medicine (Simon & Schuster, 1995) chronicles the boondoggling around 3M’s Tambocor. This blockbuster heart drug was approved by the FDA though its potentially lethal effect was already noted during clinical trials. Today the author, a senior research fellow at George Washington University, calls it “America’s worst drug disaster,” and estimates Tambocor’s victims in the tens of thousands. Yet Tambocor is still sold today.
A more recent exposé is David Healy’s Pharmageddon, published in 2012 by University of California Press. Formerly secretary for the British Association of Pharmapsychology, Healy was one of the first to call attention to how the public was kept ignorant of the suicide-inducing side effect of many antidepressant drugs like Prozac.
The AIDS establishment tries to give the impression that HIV research has kept itself pure as the driven snow. In fact, HIV science got off to a rocky start with the 1990s Gallo scandal. John Crewdson’s Science Fictions (Little, Brown, 2002) is a chronicle of Robert Gallo’s being investigated by the Office of Research Integrity for the crime of “scientific misconduct.” Gallo had allegedly falsified research and stolen credit as HIV’s discoverer. In 1995 the ORI dropped charges, admitting that its definition of “scientific misconduct” wasn’t tight enough for successful prosecution. But Gallo’s actions cost him his NIH job and the Nobel Prize.
As development of AIDS drugs got under way, Bruce Nussbaum broke into print with his Good Intentions: How big business and the medical establishment are corrupting the fight against AIDS (Atlantic Monthly Press, 1990). A senior writer at Business Week, Nussbaum told the not-very-inspiring story of how AZT was steamrolled into place as the first drug of choice, despite early concerns about its toxicity.
About this time, some of the heavyweight peer-reviewed science publications started feeling queasy about “conflict of interest,” which can also be prosecuted as a federal crime. Growing numbers of scientists were taking money from pharmaceutical companies, for consultancies or ghostwriting articles—to the point where their views or research might be tweaked in Big Pharma’s favor.
First to speak out was the prestigious New England Journal of Medicine. In 1990, NEJM adopted a policy that (in their words) “prohibited editorialists and authors of review articles from having any financial connection with a company that benefits from a drug or device discussed in the editorial or review article.” “In our view,” NEJM said, “the increasing involvement of researchers in commercial activities makes this policy all the more important.”
But by 2000, it was getting hard to find authors who were free of interest. The magazine’s editor-in-chief, Marcia Angell, felt compelled to publish a now-historic editorial titled “Is Academic Medicine for Sale?” Eventually she left the magazine and became a voice on medical research ethics, writing her own book exposés. Today Angell has this damning comment: “It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion.”
Today, more and more, science publications retract a peer-reviewed article, once they learn of a problem with it. According to a study done by Journal of Medical Ethics, the years 2001–06 saw a 500 percent increase in retractions, while 2006–11 saw another increase of 159 percent. World of Psychology said, “Of the 742 papers that were withdrawn from 2000 to 2010, the analysis found that 73.5 percent were retracted simply for error, but 26.6 percent were retracted for fraud.”
ORI did tighten their ability to prosecute. “Scientific misconduct” is actually punishable by federal prison if the offense is glaring enough. Other offenses by science, like conflict of interest, can be prosecuted directly by federal prosecutors outside of ORI. But do any of these real-life bad guys ever wind up behind bars? In 1999, when VaxGen was trying to get its AIDSVAX vaccine research financed, the company got a little help from a friend inside the CDC. VaxGen founder Don Francis, who once worked at the CDC, connected with Dr. William Heyward, head of the agency’s HIV-vaccine unit. Heyward hyped AIDSVAX to his colleagues so well that the agency coughed up an $8-million grant. Heyward also touted AIDSVAX to the media, giving VaxGen’s stock a boost on the market. Shortly after the grant, Dr. Heyward left CDC to be VaxGen vice president. Eventually House investigators learned that Heyward’s job deal had been struck before he started lobbying for VaxGen. Federal prosecutors charged Heyward with violation of criminal anti-graft laws applying to public service. But the doctor got off with no prison time and a $32,500 fine. And the AIDS vaccine turned out to be a flop.
ORI’s Web page reveals that most researchers charged under their regulations are found not guilty. Or they are let off with administrative actions like a fine. So far, only one researcher—yes, just one—has actually gone to prison for scientific misconduct involving research fraud. The U.S. now has over two million people behind bars—and that total even includes a few Wall Streeters who committed banking and mortgage fraud. My conclusion: It’s easier to jail a crooked banker than a crooked scientist.
Government inaction has also helped scientists avoid full transparency. In 2005, the Associated Press learned that, five years earlier, the Department of Health and Human Services had quietly started requiring NIH scientists to disclose their financial interests to people whom they were soliciting for clinical trials. In other words, those who were risking their bodies for research had a right to know if the researchers stood to make money off that risk. However, NIH had quietly failed to put the HHS policy into effect—which meant that ninety-one of their scientists, including Anthony Fauci himself, were still receiving their royalties in official secrecy. Fauci was getting large checks from his patent on interleukin-2, subject of one of the largest AIDS research projects at that time. The AP’s hot ray of sunshine forced NIH to scramble around and put the policy into effect.
The AP had harsh words. It said: “Self-regulation and peer review have proven about as reliable at ensuring ethical and scientific integrity as expecting the Mafia to vouch for the honesty of one of its own.”
What does this real-life “corruption of commercial interests” do to the morale of those men and women living with AIDS who commit to treatment with whatever ARVs and treatment modes have made it to market? The ones who stake their lives on assumptions that they’ve been told the truth about HIV science? They’ll have to pin their hopes on whatever good guys are left in the multi-bazillion-dollar biomedical business.
NEJM: “Is Academic Medicine for Sale?”
ORI case summaries: 1994–present
Author of fiction bestsellers and provocative commentary, Patricia Nell Warren has her writings archived at www.patricianellwarren.com. Reach her by e-mail at email@example.com.
Copyright © 2012 by Patricia Nell Warren. All rights reserved.