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.
LEADING
BY EXAMPLE
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.
A
WRENCH IN THE WORKS
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.
DEFENDING
THE GRAVY TRAIN
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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