APRIL 15, 2005

The secret of NIH: Money muddled research

A leaked internal memo from 1995 sullies the Institutes' reputation for unbiased research

There has always been a lot of money sloshing around the US bioresearch industry, but since the mid-1990s ever more of this lucre has been finding its way to NIH researchers. Intrepid reporters at the LA Times and the New York Times as well as inquisitive Congressmen like Democratic California Representative Henry Waxman have dredged up enough dirt on rampant money-grubbing impropriety at the NIH that the situation is a bona fide scandal. And this scandal at the NIH is serious enough to make some observers call into question all of their findings and pronouncements since 1995, when then-director Dr Harold E Varmus threw open the gates to private consulting in an internal memo which has only just surfaced.

Since then, scientific integrity appears to have taken a backseat in the race to secure lucrative consultancy fees. As well as taking cash, many of the agency's senior employees hold pharmaceutical and bioresearch investments in companies whose commercial performance is partly dependent on their scientific backing.

A series of Congressional investigations last year has revealed pervasive conflicts of interest that appear to get more serious the higher one looks up the ladder. The most damaging example, perhaps, is Dr H Bryan Brewer, Jr, who played a leading role in drawing up the nation's lipid control guidelines. Dr Brewer praised statins to the sky, never mentioning that he had received $114,000 from makers of these cholesterol-lowering drugs.

Dr Brewer may have had the biggest influence, but in monetary terms he is relatively small fry by NIH standards. Dr P Trey Sunderland, III, a senior psychiatric researcher, took $508,050 in fees and other related income from a drugmaker while studying their Alzheimer's medication for NIH. He later praised the drug on national television, as an NIH employee, without mentioning his payoff.

Dr Harvey G Klein, the NIH's top blood transfusion expert, accepted $240,200 in fees and 76,000 stock options over the last five years from companies developing blood-related products. All the while, he regularly wrote or spoke about the usefulness of such products without publicly declaring his company ties.

And the helping hand from NIH scientists could go beyond just touting drugs. Dr Lance A Liotta, a laboratory director at the National Cancer Institute, took $70,000 from the commercial rival of a company with which he was working in his official capacity to develop a new ovarian cancer test. After he got his money, the work inexplicably ground to a halt, prompting a complaint from the developer. The NIH backed Dr Liotta.

These arrangements were not viewed as conflicts of interest by the NIH. All senior employees were actively encouraged to seek industry consultancies, most were allowed to file confidential income disclosure forms, and almost any link was tolerated if it was declared. So far, Congress has identified 530 employees who took payments that could cause conflicts of interest — yet only 50, it seems, broke the rules.

Congress made it clear to the NIH that new rules are needed, and their complaints have been heeded. NIH Director Dr Elias Zerhouni and his deputy Dr Raynard Kington seem to have been genuinely shocked by the extent of corruption in the agency, and have acted to overturn the permissive rules introduced in 1995.

From April, NIH scientists will no longer be able to accept consultancy fees from the biomedical industry, and 7,000 senior scientists will no longer be able to hold biomedical stock, since their pronouncements can have such a dramatic effect on share prices. More junior staff will be limited to $15,000 of stock.

But many NIH scientists are in open revolt. A delegation of NIH scientists met with Zerhouni to protest the new rules, which, they claimed in an open letter, "will have profoundly detrimental financial impacts on individual employees and hinder recruitment and retention."

Dr Zerhouni seems inclined to let the rebels go, on the principle that bad information is worse than no information. Three of the senior scientists most heavily embroiled in the controversy, Drs Brewer, Liotta, and Emanuel F "Chip" Petricoin, III, who took money from the same company that paid Dr Liotta, announced their departure this month. (March 8)

Despite a concerted press and letter-writing campaign questioning his ability to lead the Institutes, in which former director and Nobel Laureate Dr Harold Varmus has joined, Dr Zerhouni is adamant that he won't back down. "I have taken a strong position to protect the credibility of NIH science," he told the LA Times. "You must not serve two masters."

But what of research that came from the NIH from 1995 to the present day, at a cost of over $200 billion to the US taxpayer? It now has a question mark hanging over it. Yet the original reasoning behind allowing secret payments was that closer ties to industry make public science cheaper.

The NIH scientists argue that their scientific judgment is not tainted by financial concerns. But critics point to the panel of FDA scientists who voted last month on the fate of Cox-2 inhibitors. They decided to keep the drugs on the market. Ten of those 32 panellists had financial ties to the drugs' manufacturers, according to a study by the Center for Science in the Public Interest, and these ten voted overwhelmingly in favour of the drugs' continued sale. Had the paid scientists been disqualified from the panel, the drugs would have suffered a defeat at the hands of the unpaid scientists.



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