Re: USA Today Exposes Conflicts of Interest in FDA Drug Approvals

From: hickwithverylitlelyme (hickwithverylitlelyme_at_somewhere.net)
Date: 06/14/04 

Date: Mon, 14 Jun 2004 11:01:48 -0400

READ THIS WEISMAN......

THAT LOOKS LIKE PROOF,THE FDA IS A FRAUD
"hickwithverylitlelyme" <hickwithverylitlelyme@somewhere.net> wrote in
message news:0kgzc.749$Hp2.544@fe39.usenetserver.com...
> TELL US ITS NOT ALL ABOUT MONEY......
>
>
> 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:
>
> 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.
>
> "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.
>
> Powerful panels
>
> 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.
>
> Types of conflicts
>
> 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.
>
> 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.
>
>
>
>

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