Protecting the View from Mt. NIH

A little over a decade ago, a senior scientist at the National Institutes of Health came up with an accurate 3-D model for an enzyme inside the HIV/AIDS virus. It was a time when nearly 40,000 Americans were dying a year from AIDS and the three existing drugs were ineffective. This scientist believed his model held the key to developing a new class of drugs that would finally control the disease.

So what did he do? Did he patent his insight? No.

Did NIH sign an exclusive research agreement with a firm that wanted to use his model? No.

Did the scientist sign lucrative consulting contracts with every company that wanted access to his knowledge? No, not that either.

This was in the days before former NIH director Harold Varmus relaxed the rules prohibiting such consulting gigs. So this scientist did what NIH scientists had always done: he made unpaid visits to any drug company or academic lab that would have him. He made unpaid presentations about his discovery. He showed slides of the enzyme’s chemical structure and encouraged everyone to work on the project. And a few years later, the first drugs that inhibited the enzyme – the HIV protease – came on the market and became the third and final leg of the triple cocktail that finally reduced the deadly toll from AIDS.

I thought about that story last week after reading some of the inane commentary about NIH director Elias Zerhouni’s decision to ban agency scientists from having outside financial ties with drug, biotechnology and medical device companies. In announcing the new directive, which was actually rammed down the agency’s throat by the Office of Government Ethics and the determined reporting of David Willman in the Los Angeles Times, Zerhouni sounded the right notes. NIH must “preserv(e) the public trust,” eliminate “conflict of interest or the appearance of conflict of interest” and maintain “at least one source of public health information in the country that can be completely trusted.”

But many press accounts, including on National Public Radio and in the Washington Post (where this was a very big hometown story – the majority of NIH’s 17,500 employees work just outside the nation’s capital), predicted nothing but negative effects. This will set back the commercialization of NIH knowledge, they said, drive the best and brightest into the private sector and hamper industry by cutting off access to NIH’s cutting-edge science. “What great public purpose is served by preventing (NIH scientists) from making a buck by sharing that informal knowledge with profit-making companies,” Post business columnist Steven Pearlstein asked in a typical comment.

Here’s the answer: The total ban will prevent NIH scientists from engaging in what has become a misguided biomedical industrial policy. Financial entanglements with private firms are, in effect, an effort (biased by personal financial gain) to pick winners and losers among different approaches to curing disease, which is, after all, the agency’s mission.

Congressional hearings and Willman’s articles focused attention on the sheer greed of some of the NIH scientists who’d parlayed their taxpayer-funded knowledge into lucrative consulting careers. It’s not a pretty picture when a senior heart disease researcher pens an article for a drug-industry funded journal supplement whose sole purpose is to sell more statin drugs, or a mental health researcher takes in more than a half million dollars in fees from Pfizer, a maker of antidepressants.

But these flagrant abuses don’t get at the heart of the problems caused by senior NIH scientists taking money from private firms. Real medical innovation, the kind of breakthrough science that NIH is supposed to develop, takes a long time. It inevitably involves many twists and turns, blind alleys and serendipitous events. The bottom line is that breakthroughs or even a major advance in the war against a disease are rare.

If scientists sign on with a particular firm with a promising approach, they tie their personal financial fortunes to the success of that approach. Will they give the same service to other firms that have alternative approaches but may not have won financial backing (and hence the ability to pay the fee) from Wall Street? Will academic labs with promising approaches (many of the best new treatments begin in academia and then get transferred to industry) get short shrift? Will the desire to keep the money rolling in blind NIH scientists to new information that suggests their client’s approach may no longer be valid?

A total ban on outside consulting, honoraria and the like is the right solution. This isn’t about purity or appearances. One of the great privileges of working for the nation’s premier biomedical research institution is that it gives its scientists a panoramic view of developments in their fields. It enables them to focus on the most promising developments. That’s why over the years so many critical breakthroughs in the directed research programs aimed at combating AIDS, cancer or rare diseases have come from the 27 institutes and centers that make up the agency. Taking money from a player in a field is like being allowed to climb to the top of Mt. Everest and then looking in just one direction.

Will prohibiting financial ties with industry stop NIH scientists from talking to industry scientists? The summary of the new guidelines posted on the NIH website refers to any “compensated or uncompensated employment.” But the detailed Federal Register notice suggests that while uncompensated “employment” is prohibited (serving on a company’s scientific advisory board is a typical uncompensated arrangement), there is nothing to stop scientists from engaging in normal scientific exchanges with their peers in either the private or public sectors. That AIDS researcher would not have been stopped by the new rules.

Will the ban drive the best and brightest away from careers in the public health service? NIH has always been seen as a way station by many medical researchers. They come for a few years to get that panoramic view and engage in pioneering research without teaching responsibilities. Many then leave for either academia or industry. But some devote their lives to public service.

I hope our culture hasn’t become so crassly commercial that there are no longer young scientists who want to climb to the top of the mountain, or veteran scientists who won’t stick around to enjoy the view.

Posted by gooznews at February 6, 2005 02:23 PM