Is Academic Medicine for Sale?

A life-and-death question is in the air, about medicine and money.

Recently the New England Journal of Medicine voiced growing unease with conflict of interest, in a landmark editorial titled "Is Academic Medicine for Sale?" Conflict of interest means financial ties that confer inappropriate or even illegal income to a scientist. In the same issue, NEJM's national correspondent, Dr. Thomas Bodenheimer, described two major studies in which most of the researchers have money ties to manufacturers of the very drugs they're studying.

Any Internet search shows that issues of "ivory tower crime" have been hotly debated since the late 1980s -- mostly behind the scenes, in scientific publications and the so-called alternative media. Some scientists view the debate as an attack on science, while others welcome it. In 1996, Scientific American complained that some scientists' secrecy around important discoveries is motivated by their intent to file lucrative patents. The magazine quoted Steven A. Rosenberg, chief of surgery at the National Cancer Institute, as saying that, "it is a very clear moral issue.... humans beings suffer and die who need not have done so."

In a word, some people are getting too cozy at that nexus where health science, government, business, nonprofits and media all intersect. In the current permissive atmosphere, some scientists can reap huge profits and power from unchallenged conflict of interest. Along the way, not only can "scientific truth" be skewed, but people's lives and health can be destroyed.

The New England Journal of Medicine, feeling that the public should know who is paying who, now requires financial disclosure by authors of original research articles. Some disclosures are so lengthy that the magazine can't print them all, so posts them on its website! The NEJM confessed that it had a hard time finding editorialists whose financial profile is clean enough for credibility. It said:

"Ties between clinical researchers and industry include not only grant support, but also a host of other financial arrangements. Researchers serve as consultants to companies whose products they are studying, join advisory boards and speakers' bureaus, enter into patent and royalty arrangements, agree to be the listed authors of articles ghostwritten by interested companies, promote drugs and devices at company-sponsored symposiums, and allow themselves to be plied with expensive gifts and trips to luxurious settings. Many also have equity interest in the companies."

Added NEJM: "Many researchers profess that they are outraged by the very notion that their financial ties to industry could affect their work. They insist that, as scientists, they can remain objective, no matter what the blandishments. Can we really believe that clinical researchers are more immune to self-interest than other people?"

Prodded by this controversy, the U.S. government may be on the verge of tightening federal standards on how scientists operate. Indeed, the Public Health Service started its Office of Research Integrity in 1989, in the wake of scandals around HIV research done by Robert Gallo's "dream team". The problem is, ORI doesn't look closely at conflict of interest. It focuses on what's called "scientific misconduct" -- namely fabrication, falsification or plagiarism in research data. Last year the Public Health Service proposed stricter standards -- but these do not address financial misconduct.

For politicians, conflict of interest is a deadly issue -- especially in election years. As I write this, Al Gore fights off those stinging wasps of allegations about the Buddhist temple fundraiser, while George Bush and running-mate Dick Cheney fight off stinging allegations about their financial ties to the Texas energy industry. Newt Gingrich stopped being a contender when the public realized he'd been lobbied by Big Tobacco. Financial misconduct can heat up special-prosecutor investigations (as in the Monica Lewinsky affair), even result in indictments (as it did recently with alleged pay-offs around the Salt Lake City Olympic Games).

Big Tobacco investigations have spotlighted scientific conflict of interest with searing political clarity. In a recent Reuters report, a European executive of Philip Morris admitted that his company had paid scientists to attend WHO meetings and try to influence WHO's anti-tobacco campaign.

But the average citizen who is shocked at Big Tobacco's maneuvers should be shocked that the same threat of "paid scientists" looms over Big Medicine as well.

Would you believe children's vaccines? The national mandatory-vaccination program for children is growing, and enormously lucrative. In 1991 the National Vaccine Information Center asked for the resignations of two scientists, citing their conflict of interest for receiving over $800,000 in fees and grants from vaccine manufacturers. The NIH refused to take action.

In a related case, reporter Barry Forbes wrote in The Tribune, Mesa, Arizona:

"Seems that a couple of key federal advisory committess involved in vaccine approval got their fingers caught in the cookie jar. These committees advise the U.S. FDA and CDC on which vaccines to approve and foist on an unsuspecting public, and which ones to add to the incredibly lucrative Childhood Immunization Schedule. The Committee on Government Reform discovered that 3 out of the 5 FDA advisory committee members who voted to approve the deadly rotavirus vaccine in December 1997 had financial ties to pharmaceutical companies. Remarkably, those same companies were developing different versions of the vaccine. Ditto for 4 out of the 8 CDC committee members in June 1998. The vaccine was pulled from the market after it was found to cause severe bowel obstructions."

These cases are not isolated aberrations, and show how the medical and life-sciences industry has become one of the world's biggest -- rivaling food, energy and armaments, with dizzying profits from global marketing of vaccines, tests, drugs and food supplements to billions of people worldwide. Without a doubt many of the products they make are beneficial, when marketed in a legitimate way according to genuine need. When I had Lyme disease, I was glad for a new antibiotic that provided effective treatment!

But this volatile mix of medicine and politics brings mixed blessings. According to the Public Citizen's Congress Watch, pharmaceutical companies are not only the biggest lobby spenders in Washington, but also major contributors to Presidential campaigns. Big transnational companies have a vested interest in which party controls the White House and Congress. They aim to maximize global profits by getting tariffs lifted on drug exports, extending current patents and preventing developing countries from manufacturing their own inexpensive generic drugs. They spend liberally on R & D, ever searching for that new drug to amp profits.

With all this money around, the temptation to skew a study in an alluring direction might be hard for a scientist to resist.

Indeed, things are so relaxed that some scientists don't bother to hide business connections that would be a PR problem for the average politician: industry grants, industry-paid trips to conferences, industry consulting fees, patent ownerships, etc. They insist that this is simply how science has to be done these days. Internationally, "partnership" is the buzzword as the UN, World Health Organization, IMF and World Bank all work openly with scientists, transnational corporations, governments and NGOs in "partnerships" that sell health care and medical products to the world. Recently a group of UN observers expressed concern at how the UN, once widely viewed as a bastion of international integrity, is becoming a clearinghouse of commercial interests.

Indeed, few global health players hide their coziness with the World Bank. Among corporations, for example, Glaxo Wellcome is poised to market AZT to millions of HIV+ mothers and children around the world -- thanks to U.S. and WHO policy making AZT a recommended drug. As I learned from Glaxo Wellcome's website, two people on its board of directors, Ronald H. Schmitz and Michele Barzach, also hold current positions within the World Bank system. (As I wrote this, Glaxo Wellcome merged with SmithKline Beecham Plc, forming the world's 2nd largest pharmaceutical company). Among NGOs, there is the powerful International Association of Physicians for AIDS Care, with 10,000 members who are doctors and health-care professionals in 52 countries. According to their own website, IAPAC is partly funded by drug companies, and has its partnership with the World Bank. IAPAC's own conferences are drug-sponsored.

Even the recent XIII International AIDS Conference in Durban, South Africa, which got so much publicity positioning as a humanitarian event, was funded by corporations and branches of the U.S. government. Most of Durban's presentations and workshops focused on drugs. Why should anyone be surprised at the strong pro-industry noises that came out of this conference?

But industry is not the sole axis of financial leverage. U.S. government money continues to flow freely into medical research (though in other areas, the end of the Cold War and Congressional budget-cutting has slackened government R & D). NIH and the National Institute of Allegies and Infectious Diseases are still funding many scientific studies. The federal government has a track record of withholding funding, or threatening to withhold it, if you don't toe the party line. It frequently jawbones cultural institutions and public schools with this threat. Recently Uncle Sam even threatened to withhold disaster-relief funds from the states! One can't help but wonder to what degree the threat of government funding loss is a factor in what some scientists may "discover."

Each year, ORI investigates several dozen cases of "ivory tower crime." The investigations are closed, low-key. Last year, according to ORI's website, 12 scientists were found "guilty" of scientific misconduct. Sentences are light, considering that this "misconduct" might risk human lives. Typically the person must formally retract the faulty research, can't be eligible for federal funding for 5 years, etc. Often perpetrators are small fry -- like the Colorado nurse who altered research data to allow ineligible patients to qualify for AIDS research.

The military, who also fund medical research, is equally eager to keep science crime out of the news. Among other things, they have an interest in vaccine research because of their mandatory-vaccination policy for personnel.

Investigation of Lt. Col. Robert Redfield (also a member of Gallo's team) and his alleged manipulations of HIV viral-load figures was done "internally" by the Army. Dr. Redfield was cleared of the charges. But, according to Public Citizen's Health Research Group, "the version of the Army internal investigation that can be obtained through the Freedom of Information Act has approximately 50% of its contents whited out, lending new meaning to the term whitewash. Public Citizen has sued the Army under the Freedom of Information Act seeking the full report, and that suit is currently before the D.C. District Court."

But it's in the AIDS world where the conflict-of-interest questions have been most doggedly avoided. It doesn't take a rocket scientist to figure out why. Global AIDS policy takes an absolutist position, based on assertions that HIV science is absolutely accurate. It is said that HIV is absolutely the cause of AIDS, that HIV tests and approved drugs are absolutely beyond factual challenge. Indeed, in a recent speech, one absolutist -- Dr. Mark Wainberg, president of the International AIDS Society -- openly called for AIDs dissenters to be jailed. Even most major media have bought the absolutist HIV position. 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. Today HIV absolutism would be threatened if a single "AIDS science for sale" investigation were to be breaking news for a few months. Public confidence in AIDS policy would go up in smoke. Perhaps this explains why, after l'affaire Gallo, science scandal has been kept behind the scenes as much as possible.

In my opinion, we should hold biomedical scientists as ethically and legally accountable as we do our politicians and our judges. After all, it's our lives we're talking about here. How amazing that a scientist can call for criminal penalties for anyone who publically questions HIV research, yet scientists who do commit research "misconduct" get a slap on the wrist.

Yes, we need answers to this urgent question: how much of today's AIDS research is truly "scientifically accurate" -- and how much of it is a house of cards held in place by somebody's ability to pay? With all the talk of AIDS being a national security threat, and UN troops enforcing global AIDS policy, the United States has no right to proceed as long as this life-and-death question is hanging in the air. Science for sale, and the potential for fraud and health danger it may cause, will have a bomb-blast effect on billions of people's lives -- and on health care -- for a long time to come.



For further reading:

New England Journal of Medicine at www.nejm.com

Reuters story about NEJM stand at www.harmsen.net/heal/abcnewsunder.html

Nicholas Regush, ABCNews, on conflict of interest at www.abcnews.go.com/sections/living/SecondOpinion/secondopinion.html

Patricia Nell Warren, author of The Front Runner, writes commentary for many gay and mainstream publications. Her editorials are archived at wildcatpress.com. Email: patriciawarren@aol.com.

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