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USA Today Exposes
Conflicts of Interest in FDA Drug Approvals
USA TODAY
analyzed financial conflicts of interest on the 18 expert advisory
committees established by the Food and Drug Administration's Center
for Drug Evaluation and Research. These committees vote on whether
new drugs should be approved and what regulations should govern the
drug approval process. The newspaper created a database of financial
conflicts disclosed at all 159 advisory committee meetings from Jan.
1, 1998, through June 30, 2000. About 250 members appeared 1,620
times during those meetings.
As required by law, FDA advisory committees
disclose when members have a financial interest in the subject of
the meeting. Financial interest is defined in FDA regulations "as
the potential for gain or loss as a result of government action on a
particular matter."
| FDA Advisers Tied to Industry |
By
Dennis Cauchon,
USA TODAY
| More than half of
the experts hired to advise the government on the safety and
effectiveness of medicine have financial relationships with
the pharmaceutical companies that will be helped or hurt by
their decisions, a USA TODAY study found. |
These experts are hired to advise the Food and
Drug Administration on which medicines should be approved for sale,
what the warning labels should say and how studies of drugs should
be designed.
The experts are supposed to be independent, but
USA TODAY found that 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.
The conflicts typically include stock ownership,
consulting fees or research grants.
Federal law generally prohibits the FDA from using
experts with financial conflicts of interest, but the FDA has
waived the restriction more than 800 times since 1998.
These pharmaceutical experts, about 300 on 18
advisory committees, make decisions that affect the health of
millions of Americans and billions of dollars in drugs sales. With
few exceptions, the FDA follows the committees' advice.
The FDA reveals when financial conflicts exist,
but it has kept details secret since 1992, so it is not possible to
determine the amount of money or the drug company involved.
A USA TODAY analysis of financial conflicts at 159
FDA advisory committee meetings from Jan. 1, 1998, through last June
30 found:
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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.
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"The best experts for the FDA are often the best
experts to consult with industry," says FDA senior associate
commissioner Linda Suydam, who is in charge of waiving
conflict-of-interest restrictions.
But Larry Sasich of Public Citizen , an advocacy
group, says, "The industry has more influence on the process than
people realize."
| Number of Drug Experts Available is
Limited |
By
Dennis Cauchon,
USA TODAY
In October, pharmaceutical giant Johnson & Johnson
sent a team of executives to a Holiday Inn ballroom in Silver
Spring, Md.
Their job: persuade the Food and Drug
Administration's panel of independent experts that an expensive
antibiotic, Levaquin, should be the first drug approved to treat
penicillin-resistant pneumonia.
For Johnson & Johnson executives, the FDA's
Anti-Infective Drug Advisory Committee included some familiar faces.
At least two of the experts were paid consultants to the drug
company and had worked on the very same medicine that they were
being asked to evaluate for approval in an important new market.
The expert panel's "consumer representative," whose assignment is
to defend consumers' interests, had the most extensive financial
relationship with Johnson & Johnson.
Keith Rodvold, a pharmacy professor at the University of
Illinois-Chicago, serves on a company anti-infective drug advisory
board, according to Johnson & Johnson spokesman Marc Monseau.
Rodvold advised the company on how to design and analyze the
clinical trials that got the drug approved. In 1999, he designed a
study to measure how Levaquin is absorbed in the lungs. The company
also uses him regularly as an consultant on a variety of issues,
Monseau says.
Rodvold declined to discuss his relationship with
Johnson & Johnson and his work on Levaquin. The company declined to
say how much Rodvold had been paid during the five years he has
consulted for it.
The case of Levaquin reveals how deeply
pharmaceutical industry money and influence penetrates the drug
approval process. FDA advisory committees consist almost entirely of
pharmaceutical industry consultants and researchers. Even consumers'
and patients' representatives on the committees often receive drug
company money.
At least one committee member had a financial
stake in the topic under review at 146 of 159 FDA advisory committee
meetings, according to a USA TODAY study of advisory committee
meetings held from Jan. 1, 1998, through June 30, 2000. At 88 of
those meetings, at least
half
the advisory committee members had financial interests in the topic
being evaluated.
Eighteen FDA advisory committees play a crucial
role in nearly every major decision on drug regulation. They help
decide what drugs should be approved and how the pharmaceutical
industry should be regulated. In
recent years, the FDA has followed every advisory committee
recommendation to approve or reject a medicine - except once,
FDA spokeswoman Susan Cruzan says. (The FDA approved the flu drug
Relenza in July 1999 despite an advisory committee voting 13-4
against approval.)
Investors follow advisory committees closely. A
committee vote can add or subtract hundreds of millions of dollars
from a drug company's stock market value.
The FDA is required by law to screen all committee
members for financial conflicts. The law says members have conflicts
when committee action could have the "direct and predictable effect"
of causing the member a financial gain or loss. The federal agency
is forbidden from using experts with financial conflicts unless a
waiver is granted, usually on the grounds that the experts' value
outweighs the seriousness of the conflict. The FDA grants these
waivers routinely.
In the period analyzed by
USA TODAY, the FDA granted 803 conflict-of-interest waivers.
Seventy-one other times, members had financial conflicts that were
voluntarily disclosed but did not require a waiver.
In the 746 other member appearances on the committees,
there was no conflict of interest.
The FDA says granting waivers lets it tap the
nation's leading researchers, most of whom do work for the
pharmaceutical industry.
"The system is designed to bring together the best
scientific experts we can find," says FDA associate commissioner
Linda Suydam, who approves waivers.
She says conflict-of-interest waivers go through
as many as eight levels of review before they are granted. But Larry
Sasich, a pharmacist who works for the Ralph Nader-founded Public
Citizen's Health Research Group, says, "It is outrageous that the
pharmaceutical industry's influence is so great that even some
consumer representatives are on drug companies' payrolls."
Sasich says it might sometimes make sense to let
experts with financial conflicts participate, but "it should be rare
and that person should not be allowed to vote."
Financial conflicts were most common when
committees considered broader issues, such as warnings labels for
pregnant women or how cancer studies should be designed. At the 57
meetings on regulatory policy, committee members had conflicts 91%
of the time.
At the 102 meetings involving specific drugs,
33% of committee members had a direct financial stake in the
outcome.
It is impossible to determine how advisory
committee decisions might have been influenced by the financial
relationships its members have. The FDA stopped making details of
financial conflicts public in 1992, after controversies about
whether the financial interests of committee members had biased
decisions on breast implants, Prozac and a drug to treat Alzheimer's
disease. The FDA says it stopped releasing details on conflicts
because of concerns about violating the privacy rights of committee
members, not because of the controversies.
Financial conflicts include 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.
Many financial conflicts are considered too
small to require disclosure or a waiver and were not counted in USA
TODAY's study. For example, a committee member can be paid up to
$50,000 a year by a drug company without any financial conflict
being disclosed if the work was on a topic other than what the
committee is evaluating, according to FDA guidelines. Committee
members also can own up to $5,000 in stock in the company appearing
before the committee.
Advisory committees include many of the nation's
leading researchers. The pay is not high considering the stature of
many members: about $400 a day for meetings, plus travel expenses,
and nothing for work done outside a meeting. However, the
assignments are prestigious, and committee members, whose terms last
four years, are in heavy demand as industry consultants.
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Conflicts are most common on the committees that consider
heart drugs. Forty-eight percent of experts had financial
conflicts when considering the worthiness of specific heart
medicines. |
"The greater degree of expertise, the greater the
potential for conflicts," says Milton Packer, chairman of the
Cardiovascular and Renal Drugs Advisory Committee.
Packer is a good example. He is a leading figure
in cardiovascular research and has helped pioneer the development of
drugs to treat congestive heart failure. Last year, he led an effort
by 150 leading cardiac researchers to establish consensus guidelines
on how to treat congestive heart failure, which is suffered by 5
million Americans.
But his work with pharmaceutical companies creates
many financial conflicts. The FDA granted him a waiver that allowed
him to participate in a meeting May 2 on the drug Refludan, which
treats clotting. (Packer says he doesn't recall what the conflict
was.) And Packer did not participate in a meeting May 1 on the heart
drug Altace because of a financial conflict. (He declines to say
what the conflict was.)
Packer says consolidation in the pharmaceutical
industry has increased the potential for conflicts because there are
fewer companies and nearly all have heart drugs.
Financial conflicts are so common that eight of
10 members who evaluated the drug Aggrastat, made by Merck, had
conflicts of interest.
Packer says he doesn't believe that financial
conflicts distort the recommendations of advisory committees: "
There are so many checks and balances, it would be almost impossible
for a single individual to steer the committee."
At the meeting on October 20, 1999, on Levaquin,
the chairman of the committee and one other member stepped aside
because of financial conflicts.
Of the 10 members remaining, four had
received conflict-of-interest waivers from the FDA.
In addition to Rodvold, New Jersey physician Carl
Norden had consulted for Johnson & Johnson in 1997 on the design of
Levaquin studies for illnesses other than the treatment of
penicillin-resistant pneumonia, the company said.
Johnson & Johnson says having its consultants on
the advisory committee didn't create bias.
"We don't believe (advisory panel members) would
let a consulting arrangement compromise their reputation and stature
in the medical community," says Monseau, the Johnson & Johnson
spokesman.
The advisory committee voted unanimously to
recommend that Levaquin, an $8-per-pill antibiotic, be approved for
treatment of penicillin-resistant pneumonia. The FDA ratified the
decision in February. Levaquin has been on the market since 1997,
but the FDA's action allows Johnson & Johnson to market the medicine
as the first antibiotic approved for the more than 25% of pneumonia
cases that are resistant to penicillin.
Industry influence on advisory committees will
increase later this year. As required by a law approved in 1997, the
FDA will add official industry representatives to the committees.
The industry officials will participate in deliberations, but they
will not be allowed to vote.
These articles originally appeared in the
USA TODAY
September 25, 2000 -
Click
here for original article.
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