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Science and shams

THE NATIONAL preoccupation with university researchers who collaborate with drug companies has now blossomed into a full-fledged witch hunt. Before we burn these heathen scientists at the stake, however, we might want to step back and examine our underlying assumptions.

The worry about academics working with industry stems from the fear that drug company money will bias the conclusions of otherwise trustworthy university scientists. Yet this argument is ultimately a dangerous sham -- a sham, because it derives from a naive preconception about the purity of academic scientists, and dangerous, because by discouraging collaborations between researchers from university and industry, we will slow the pace of medical progress.

The quaint notion that university researchers operate on a higher moral plane than business people might be charming if the implications weren't so profound; attention-getting results can lead directly to employment, promotion, and prizes, all leading to personal gain. Not surprisingly, some of the most notorious perpetrators of research misconduct have been academic investigators with no company relationships.

While fraud itself is fortunately quite rare in science, you still shouldn't believe everything you read. It turns out that the scientific literature is characterized by a shockingly high rate of irreproducibility, often estimated to exceed 50 percent. A review of this subject last year in the journal PLOS-Medicine by Dr. John Ioannidis became an instant cult classic.

Among the factors associated with irreproducibility includes a category Ioannidis terms ``financial and other interests and prejudices," since ``prejudice may not necessarily have financial roots." Such nonfinancial prejudice may include a bias toward a particular scientific theory, a bias against competing researchers or perspectives, and a desire to generate publications for career advancement. Unfortunately, the newfound obsession with financial conflicts of interest obscures these other, often more compelling pressures on university researchers.

Ultimately, the myopic focus on financial conflicts is likely to discourage relationships between university researchers and drug companies -- a bad idea, since these associations offer enormous potential for medical advancement.

While almost all of the basic research in the nation occurs at universities, translating these discoveries into clinical application generally requires the contribution of industry. In fact, the initial scientific insight, though essential, is typically only the first step of an exceptionally long, difficult, and characteristically unsuccessful process, since only a vanishingly small number of leads ultimately evolve into clinically significant products.

The commercial development of a new drug or device is frequently catalyzed by the contributions of academic experts at many steps along the way.

Basic scientists contribute detailed knowledge of the biological pathway the new agent will target, for example, while clinical researchers provide important information about the medical condition the new product will treat. Not surprisingly, the same university researchers sought out by industry can also provide valuable insight to scientific colleagues, in the form of review articles, and to government regulators, through participation on FDA advisory committees. But both of these activities have alarmed critics, who maintain that researchers with industry involvement are indelibly tainted and no longer worthy of our trust.

To be sure, drug companies have brought some of this skepticism upon themselves. Consider Nexium, a product created not to address an unmet medical need, but purely to offset the fact that the company's previous (and fundamentally identical) heartburn drug, Prilosec, was about to go off-patent.

At the same time, I've also seen patients on death's door recover because they were given a powerful new antibiotic, or because their condition was accurately diagnosed by a technologically advanced machine. I've also had the remarkable experience of restoring the vision of a patient who had nearly gone blind because a fast-growing pituitary tumor had compressed his optic nerves; treated with the appropriate drug, the tumor receded within days. In each of these cases, patients benefited from the extensive efforts of a drug or a medical device company, and from the pivotal role played by the academic physicians who worked with the company to accelerate the development of these important products.

Coming up with novel treatments for dreadful diseases is a difficult enough task under the best of circumstances; let's not complicate this mission further by misjudging either the intrinsic virtue of academic scientists or the alleged venality of drug companies; instead, let us learn how to foster productive, transparent collaborations so that the promise of modern science can be realized in the treatment of our patients.

David A. Shaywitz is an endocrinologist at Massachusetts General Hospital.

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