Left Field by Patricia Nell Warren

Six years ago, I first reported on the current meltdown in medical research ethics, comparing it to the danger of a badly run nuclear power plant. The kickoff column was titled “Science for Sale.” The New England Journal of Medicine had just published an editorial that shook everybody up—the editors admitted it was getting hard to find medical writers who don’t have smelly ties to pharmaceutical corporations. Many of the AIDS media, gay media, and mainstream major media were avoiding these corruption issues, because they’re under the thumb of their pharma advertisers.

Since then, it has taken the independent media, plus wire services like the Associated Press and Bloomberg News, who are freer to report the facts because they don’t take a lot of advertising, to get the truth out.

The ethics meltdown looms especially vast in the AIDS world. Why? Because the AIDS establishment takes an absolutist position that AIDS research is all accurate and all trustworthy, all the time—that it must be politically supported by all Americans, whether patients or taxpayers. What I said in 2000 still holds true: “We are expected to believe that AIDS research, alone of all areas of science, is magically free of undue influence or those ‘sales of academic medicine’ that has the NEJM so worried.”

Yet behind the absolutist stonewall, the ethics problems can be found in AIDS research. Examples:

• One third of the federally-funded scientists questioned in a recent poll admitted anonymously to engaging in unethical practices, according to a Nature magazine report. As when three researchers at the University of Maryland pediatrics department admitted to faking the data in a “safe sex” study of African-American teenagers. As when Serono, a Swiss company with a U.S. division, pled guilty to cooking its AIDS research and agreed to pay $704 million in penalties to settle the criminal charges.

• Scientists and government officials often publish or speak at conferences without disclosing their income from patents, pharma consultancies, etc. As when, in a widely reported instance, NIAID director Anthony Fauci and a colleague failed to disclose their secret royalties from interleukin-2, an experimental AIDS treatment they developed together. Fauci also enhanced his own financial interests by launching some of the spendiest NIH clinical trials in history for interleukin-2, according to the AP.

• Some clinical-trial results are manipulated to fit the global political agenda for drug marketing, according to growing evidence. As when a top NIH official tampered with results of a nevirapine clinical trial in Uganda and made it look good on paper so President Bush’s plan to export nevirapine to developing countries could go forward. The government’s Institute of Medicine appointed a panel of supposed independent experts to investigate this scandal and two thirds of the “investigators” turned out to be recipients of NIH grants.

• Government agencies sometimes cover up the evidence that drugs are either ineffective or dangerous or sloppily researched. As when FDA documents revealed serious problems with a 1986 Phase II study of AZT, yet the FDA decided to accept the results anyway, and AZT went on the market. Though the study was unblinded early, it was reported in NEJM as a “double-blind” trial. NBC News did an exposé on this, but it was ignored in the rush to launch the “war on AIDS.”

• Growing evidence of illegal use of foster children in AIDS clinical trials, in apparent response to political pressures about global drug-marketing plans. As when the NIH permitted the use of hundreds of system kids in at least four dozen AIDS-drug trials in seven states. AP investigative reporter John Solomon found that these child wards of the state, mostly black or Latino, were subjected to experimental treatments with AZT, nevirapine, and other drugs without the protections and oversight guaranteed to them by federal law.

• A trend to lessen the legal protection for whistle-blowers, especially those who work for the government. As when Dr. Jonathan Fishbein, who blew the whistle on NIH about the Uganda AIDS trial, was punished by being stripped of his protection under federal law. (Fortunately, after a Congressional investigation, the NIH was compelled to reinstate him.)

Some elected officials add to the science meltdown with their own flagrant conflicts of interest. As when forty-two U.S. Senators who own stocks in pharmaceutical companies recently voted to hold vaccine manufacturers harmless for deaths or injuries resulting from unsafe vaccines.
How is America reacting to the growing rumble of meltdown deep in our science “power plant”? Medical journals, fearful for their credibility, are finally getting tougher on disclosure and prepublication scrutiny of the papers they publish. Some outraged Congressmembers are launching investigations. Even some of the mainstream media are no longer able to avoid reporting on these scandals. And the public—as they were with nuclear power—are jittery. According to a recent New York Times article, a recent poll showed that only nine percent of Americans believed drug companies were generally honest, down from fourteen percent in 2004.

RedFlagsDaily.com nailed it recently when they said in a special report, “Criminal prosecution of medical researchers with financial conflicts, who fabricate safety data, has become an essential component of regaining the integrity of device and drug research in the United States.”

Yes, a well-run nuclear power plant can be safe and provide electricity for millions of homes. And no doubt there are drugs, treatments, vaccines, and medical devices that are safe and effective, as well as scientists, pharma executives, and government officials who do give a hell about human welfare. Sick people, including those with AIDS, still hope to find effective treatments. But right now it’s getting a little hard to tell the good guys from the bad guys. As long as the U.S. fails to clean up its ethics mess, we’ll be heading straight for our Chernobyl in science research.

Further reading:
Anthony Fauci patents:
www.freshpatents.com/Efficient-inhibition-of-hiv-1-viral-entry-through-a-novel-fusion-protein-including-of-cd4-dt20041230ptan20040265306.php

http://tmh.floonet.net/articles/varmus.shtml

www.sciencemag.org/cgi/content/
summary/285/5436/2039c

Alliance for Human Research Protection page on AIDS problems: www.ahrp.org and search for “AIDS” in the site archives.

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.

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

March 2006