Last month, our trust in the objectivity of medical research was violated. The New York Times reported that a study showing that annual CT scans of smokers for lung cancer could remarkably reduce deaths from the disease was surreptitiously paid for by the tobacco industry. The 2006 study, published in the New England Journal of Medicine, was in part funded by an obscure charity, the Foundation for Lung Cancer, which, it turns out, got its money from the parent company of Liggett Group Inc., a cigarette manufacturer. A critic's designation of this funding as "blood money" quickly crisscrossed the country.
The potentially tainted lung cancer study raises a question that should give us a painful knot in our collective abdomen. What don't we know about clinical research in the U.S. that could be bad for our health?
With federal funding for research declining, private industry has stepped forward to fill the money vacuum, and many clinical investigators have eagerly accepted the largesse.
We usually think of "industry" in terms of pharmaceutical companies. But research is also paid for by food companies, disease-oriented organizations such as the American Diabetes Assn. and foundations with impressive but ambiguous names whose motives are as obscure as their titles.
For The Record
Los Angeles Times Sunday, April 13, 2008 Home Edition Opinion Part M Page 3 Editorial pages Desk 1 inches; 33 words Type of Material: Correction
Medicine: An article in the April 6 Opinion section about financial conflicts tainting medical research stated that the American Society of Nephrology issues clinical-practice guidelines. It should have said the National Kidney Foundation.
The episode that first highlighted how financial conflicts of interest might be harmful to patients' health involved Jesse Gelsinger, an 18-year-old with a mild form of a genetic disorder that made him deficient in a protein essential for metabolism. Still, he was healthy because he could manage his condition through diet and medication.
In 1999, he volunteered for a research study at the University of Pennsylvania. The scientists conducting the study replaced the gene responsible for Jesse's protein deficiency by attaching it to a common cold virus and then infecting him with the "harmless" virus. In four days, Jesse was dead.
It was subsequently disclosed that the virus-carrier technique used to treat the teenager had been patented, and that both the study's lead scientist and the medical center where it was conducted held stock in the company that owned the patent.
The scientist denied that his use of the gene therapy technique was premature. But critics wondered whether his financial interests and those of the medical center had influenced the decision to push the experiment forward before there was sufficient evidence of the technique's lack of toxicity.
Unfortunately, there are many other clinical research studies in which the participants' financial interests may have played a role. In 2003, the British Medical Journal published a summary of dozens of clinical studies on the effect of various drugs on patients. The summary showed that drug studies funded by pharmaceutical companies were about four times more likely to have outcomes favorable to the companies than similar ones paid for by such noncommercial entities as the National Institutes of Health. An analysis of more than 200 research articles on the effects of milk, soft drinks and juices on health, published in the Public Library of Science/Medicine in 2007, produced a similar conclusion. Studies paid for by milk and beverage companies were four to eight times more likely to be favorable to them than those funded by noncommercial entities.
It's not only clinical research that is corruptible. Clinical-practice guidelines for the recommended treatment of various diseases -- such as those produced by the American Heart Assn. or the American Society of Nephrology -- may also in part reflect the financial interests of contributors.
Guidelines on the use of statin drugs to lower cholesterol, nicotine patches to stop smoking, Epogen to treat anemia and testosterone to boost the energy of tired, elderly men were tainted by the participation of physicians who had accepted speaking or consulting fees from companies that stood to benefit from their recommendations, according to numerous newspaper stories, some published by The Times.
Evidence unearthed in lawsuits and by investigative reporters shows that some Food and Drug Administration panels stacked with members deemed friendly to drug companies made questionable judgments about drug approvals. One such drug was Rezulin, which is used to treat diabetes. The drug was kept on the market despite accumulating evidence that it was causing liver failure in some patients and killing others.