The Rising Health Costs of Capitalism’s Invasion of the Science Lab
News stories, published this month by The Times, that Richard C. Eastman, the top diabetes researcher at the National Institutes of Health, had received thousands of dollars in consulting fees from Warner-Lambert Co., whose diabetes drug has been implicated in 33 deaths, illuminate the extent to which the once-pristine laboratory has been tainted by corporate dollars. Compounding this apparent conflict of interest was the revelation that Eastman had been on the payroll of New Jersey-based Warner-Lambert during the time the NIH was studying Rezulin, the diabetes drug. These unholy alliances between scientists and industry have become hazardous to our health.
To the pharmaceutical industry, however, this is just business as usual. About the only thing that is different about the Eastman-Rezulin affair is that the public is getting a rare glimpse into how drug makers market their products. Eastman’s involvement with Warner-Lambert is merely a replay of a familiar scenario: A pharmaceutical company hires a “marquee scientist,” a big name in the field at a top-tier university or elite research center like the NIH, to test a new drug and extol its virtues to colleagues at quasi-educational seminars. Busy physicians, who don’t have time to carefully review all the latest scientific research, are persuaded to prescribe the drug. Soon, new treatment norms are established, which physicians are reluctant to deviate from for fear they’ll be hit by a lawsuit if something goes awry. It becomes a self-perpetuating cycle: Drug companies make millions off a medication that may be of limited benefit, or even harmful.
The academic-science community, to be sure, has always had some links to business. But that trend accelerated exponentially under the Ronald Reagan and George Bush administrations, when federal budgets for basic research were slashed and scientists were strongly encouraged to forge ties with industry to make up the shortfall. In the years since, much of the taxpayer-supported research establishment has become privatized. The upshot is that doctors are now basing medical-practice decisions on the outcomes of studies that are often conducted by researchers who have a vested interest in those outcomes.
A 1996 Harvard survey of 210 U.S. companies that fund academic scientists revealed that the growing corporate presence on campus created profound conflicts of interest. “Universities would be unwise to depend heavily on industry to sustain their capabilities in the life sciences,” the Harvard researchers concluded, “because such support may not generally be conducive to maintaining the level of excellence of fundamental academic research.”
Scientists bristle at the suggestion that their corporate ties may influence their findings or that they are just glorified industry shills. But when a company pays 10% to 20% of researchers’ incomes, along with sizable honorariums to their universities for the use of their facilities, the temptation to put a positive spin on ambiguous data or downplay negative findings can be overwhelming.
One of the more celebrated examples of this is the case of Charles Bluestone, a high-profile ear, nose and throat researcher at the University of Pittsburgh. In 1987, Bluestone published a study that indicated children with middle-ear infections (a condition known as otitis media with effusion) would benefit from antibiotics. But Bluestone failed to reveal that in addition to $10 million in federal grants, he had collected $3.5 million in drug-industry money to fund these studies, as well as $260,000 in honorariums to deliver lectures around the country. He was later censured by the NIH for these conflicts of interest, and a 1990 congressional investigation found his results to be biased.
By then, however, prescribing patterns had hardened, with pediatricians dispensing antibiotics to kids like lollipops. It wasn’t until last year that the American Academy of Pediatrics called for a moratorium on the use of antibiotics for these middle-ear infections, because of the frightening rise of antibiotic-resistant bacteria. The kicker here is that public-health officials now believe these deadly microbes gained a toehold in the U.S. population, at least in part, through overmedicated preschoolers sharing their germs in day-care centers. Meanwhile, billions of dollars worth of antibiotics were prescribed to treat ear infections.
To cite another example: When Activase, Northern California-based Genentech’s flagship clot-busting heart medication, was first tested, many of the academic researchers conducting the clinical trials owned stock in Genentech. So, it wasn’t surprising that in early tests, Activase proved superior over its chief rival, streptokinase, made by two Swedish drug companies. Later, Genentech paid tens of thousands of dollars to big guns at leading universities to conduct “educational” seminars across the country about Activase. Little wonder the clot-buster has since become the drug of choice for American cardiologists, even though it costs 10 times as much as its equally effective competitor, which, perhaps not coincidentally, is more widely used by physicians in Europe.
In a similar vein, last year, the Journal of the American Medical Assn. published the results of a university study that had been suppressed for nearly seven years. The study found that the nation’s leading thyroid medication, and second-most-dispensed drug, Synthroid, isn’t any more effective than less-costly generic versions. The reason why these findings took so long to come to light is because the drug’s maker, New Jersey-based Knoll Pharmaceutical Co., sponsored the study. Consequently, the company was able to conceal its conclusions, which could have slashed U.S. medication costs by an estimated $356 million annually, or a staggering $2.5 billion if the results had been divulged as soon as they were known. Knoll agreed last year to pay up to $135 million to settle a suit by Betty Dong, the UC San Francisco researcher who had done the study, but admitted no wrongdoing.
In the wake of incidents like these, safeguards were instituted, and everyone thought the problem had been solved. But it really hadn’t been. The elite medical publications, like the Journal of the American Medical Assn. and the New England Journal of Medicine, now detail researchers’ financial ties in order to alert readers to any possible bias. But the vast majority of journals, roughly 70%, do not, which means there’s really no way of gauging the pedigree of most research.
The NIH, as well as many universities, also has adopted financial-disclosure guidelines. But the reality is that when problems do crop up, universities are loathe to punish these rainmakers, who bring in millions in federal grants and drug-company dollars, because they don’t want to derail the gravy train. In the Bluestone case, for example, University of Pittsburgh officials exonerated him of wrongdoing. It was only when an outraged collaborator of Bluestone’s brought the incident to the attention of the NIH’s Office of Scientific Integrity, which has since been renamed and moved to the U.S. Public Health Service, that action was taken.
Even the NIH has been lax in cracking down on errant scientists because it’s hobbled by a lack of resources. One three-year congressional inquiry charged that the public health was “endangered” because the NIH did too little to keep conflicts of interest, and even outright fraud, from infecting the research it funds. And who polices the police, such as the top brass at the NIH like Eastman?
So what can be done to rectify this systemic problem? First, the NIH must take its watchdog role of monitoring these arrangements more seriously and make disclosure compulsory. The agency should be given the political mandate and staff to ensure compliance, especially at universities and research centers that don’t voluntarily do a good job.
A little sunshine can also be a great disinfectant. Disclosure regulations, which are not uniformly enforced, should become standardized and be applied to every facet of medical research, from obtaining funding and serving on federal advisory committees, to publishing papers in professional journals and lecturing at scientific forums. This financial information should be made readily available to the public and the media, whether it’s through a special-access office or on a Web site.
But perhaps the best hope lies with the dwindling number of scientists who have chosen to remain independent. There should be a way of rewarding them for their independence so this indispensable brain trust can be preserved. None of this will occur, however, until the average American realizes the vital importance to the nation’s health of having a group of unaffiliated scientists who can be relied upon for objective advice and information. Until public pressure is brought to bear, questionable arrangements like Eastman’s ties to Warner-Lambert will continue to be far too common.*
