Left Field by Patricia Nell Warren

When nuclear power launched in the 1940s, industry and government insisted it was safe. Even after meltdowns at several plants, notably Three Mile Island in 1979, the nuclear establishment tried to sooth a jittery public. Finally in 1986 the U.S.S.R.’s Chernobyl reactor exploded and turned a large area into a radioactive wasteland. Deaths eventually ran into the thousands. Today many plants are closed and a stalled nuclear-power industry is still trying to regain public confidence.

Medical-science meltdowns can be just as devastating. For twenty-five years now, the slow meltdown in American research ethics has been visible to anybody who wanted to see it. In a recent poll of 3,000 government-funded scientists, one third admitted—under cover of anonymity—that they had violated research ethics. One third! This means that Americans have to wonder whether a significant part of our recent medical and pharmaceutical development has been cooked. We’ve been jarred by recent scandals about the safety of Vioxx, Viagra, antidepressants. That Chernobyl moment is ahead—when the American public will lose a massive degree of confidence in many drugs, treatments, vaccines and medical devices.

With scandals in AIDS research also on record, AIDS science will surely get some fallout.
How did things get so out of control? In 1960, the FDA was a hero to many when it delayed admitting thalidomide to the U.S. market, saving thousands of babies from birth deformities.

The meltdown started in 1980 when Congress amended patent law so that university research—once free of commercialism—could profit from products it developed but still get federal funding. In 1986, reacting to demand for the first AIDS drug, the FDA rushed AZT to market, creating a fast track and an incentive to cut corners. In 1999 the agency allowed pharmaceutical companies to start advertising directly to consumers. Today most major media are dependent on their enormous income from drug advertising—especially TV news media, whose “reports” on new drugs often look like company infomercials. Only the indie media and the wire services like the AP, who take little advertising, had the courage to do investigative reporting on scandals.

Today the pharmaceutical industry also leverages government—it’s the most powerful lobby, pouring more than $1 billion a year into legislators’ pockets. In the process, our once-heroic FDA got cozy with the process it’s supposed to police.

According to the science magazine La Leva di Archimede, “Today, private industry has unprecedented leverage to dictate what doctors and patients know—and don’t know—about the $160 billion worth of pharmaceuticals Americans consume each year....More than 60 percent of clinical studies…are now funded not by the federal government, but by the pharmaceutical and biotech industries. That means that the studies published in scientific journals like Nature and the New England Journal of Medicine...are increasingly likely to be designed, controlled, and sometimes even ghost-written by marketing departments, rather than academic scientists.”

By 1992 there were enough scandals—notably Robert Gallo’s HIV research—that the feds knew they’d lost face. So they knocked together the Office of Research Integrity within the U.S. Dept. of Health and Human Services. ORI would prosecute crimes called “scientific misconduct” and “conflict of interest.” Charges could range from plagiarism to falsifying clinical-trial data to having a financial interest that affected your research results. Over fourteen years, ORI has found more than 100 individuals guilty. Among them was CDC vaccine chief William Heyward, who used his position to provide NIH grants for VaxGen’s HIV vaccine research when he had already accepted a VaxGen job offer. Heyward got off with a fine.

Unfortunately these laws are seldom enforced. Penalties are light—like being grounded from federal funding for a few years. These criminals don’t go to prison, even when people may die during clinical trials or suffer injury as a result of corrupted research. And ORI operates behind closed doors—convictions seldom make the six o’clock news.

Next month in Part II: AIDS research misconduct.

Further reading:
La Leva di Archimede article: www.laleva.org/eng/2004/05/why_you_cant_
trust_medical_journals_anymore.html.

Author of fiction bestsellers and provocative commentary, Patricia Nell Warren has her writings archived at www.patricianellwarren.com. Reach her by e-mail at patriciawarren@aol.com.

February 2005

Copyright (c) Patricia Nell Warren. All rights reserved.