| Compiled by GayToday
According to an investigative story in
USA Today (September 25) conflicts of interest are
corrupting the Food and Drug Administration's drug approval process.
ACT UP San Francisco's AIDS dissident, David Pasquarelli,
demands:: “Let's take this one step further, into the arena of
AIDS.” |
 ACT UP San Francisco member David Pasquarelli at a
recent demonstration |
Drug companies, Pasquarelli points out, “pay for clinical trials of
experimental products like protease inhibitors. They pay the doctors to
execute these trials. They pay the experts at the FDA who evaluate the
data and grant approval. They pay virtually all AIDS organizations to
lobby for easing the FDA regulatory process and to market their drugs to
various communities.”
According to USA Today reporter Dennis Cauchon, the
FDA's advisers are tied to industry and an analysis has found that “the
drug-approval process is riddled with conflicts of interest.”
These conflicts center around stock ownership, consulting fees,
research grants, a spouse's employment and payments for speeches and
travel.
| "The
conflict could be a tie to the company whose drug is under
consideration or to a company that sells a competing drug," writes
Cauchon.
More than half of the researchers who provide safety
information about newly produced medicines are said to have monetary
ties to the pharmaceutical companies who depend for their profits on
what the researchers decide to announce.
USA Today reports that although experts are
expected to be independent of the profit motive, 54% of the time
"they have a direct financial interest in the drug or topic they are
asked to evaluate. These conflicts include helping a pharmaceutical
company develop a medicine, then serving on an FDA advisory
committee that judges the drug." |
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Although U.S. laws are thought to prohibit the FDA from engaging in
such conflicts, the agency has waived the prohibition more than 800 times
during the past two years.
No one knows how much money has changed hands between FDA “experts”
and the pharmaceutical companies. While admitting to financial conflicts,
the FDA has remained secretive about details, reportedly, since 1992.
USA TODAY's analysis of financial conflicts at 159
FDA advisory committee meetings between January 1, 1998, through last June
30 discovered:
At 92% of the meetings, at least one member had a financial conflict
of interest.
At 55% of meetings, half or more of the FDA advisers had conflicts of
interest.
Conflicts were most frequent at the 57 meetings when broader issues
were discussed: 92% of members had conflicts.
At the 102 meetings dealing with the fate of a specific drug, 33% of
the experts had a financial conflict.
Clearly, as Larry Sasich of Public Citizen pointed out:
"The (pharmaceutical) industry has more influence on the process
than people realize." |
