Drug industry dominates FDA

Drug company influence over the "regulating" FDA is so pervasive that as USA Today found in stunning disclosures published Sept. 25 - 54 percent of the time members of "expert panels" convened by the agency to ponder a drug for approval or disapproval have a direct financial interest in the drug or topic they are supposedly evaluating.

Moreover, while the FDA allegedly reveals when conflicts of interest are present it has kept such details secret since 1992 - and a member of an "expert panel" can be paid up to $50,000 a year by a drug company or have $5,000 in stock in the company whose product is being evaluated without any such conflict of interest being disclosed.

While drug company spokesmen moved awkwardly to downplay the newspaper's survey of 159 advisory committee meetings ("expert panels") between Jan. 1, 1998, and June 30, 2000, and involving 300 "pharmaceutical experts" on 18 such panels, pharmacist Larry Sasich of the Public Citizen Health Research Group said:

"It is outrageous that the pharmaceutical industry's influence is so great that even some consumer representatives are on drug companies' payrolls.

Noted USAToday:

"These experts are hired to advise the FDA 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 percent 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 a book 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."

In information dredged up on the 159 expert-panel meetings, the newspaper found that:

• At 55 percent of the meetings, at least one member had a financial conflict of interest.

• At 55 percent of the 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 and then 92 percent had conflicts of interest.

In the cross-hairs were two particular cases in point: Johnson & Johnson's antibiotic Lavaquin, an $8-per- pill treatment of antibiotic-resistant pneumonia, and Merck's heart drug Aggrastat.

USA Today noted that in October 1999 J & J had sent a team of executives to Silver Spring, MD to persuade an FDA "experts panel" that Lavaquin should be the first drug approved to treat penicillin-resistant pneumonia.

"ForJohnson & Johnson executives, the FDA's Anti-Infective Drug Advisory Committee included some familiar faces," noted the newspaper.

"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 panel unanimously approved the request and the FDA ratified it in February 2000.

In the matter of the burgeoning market in heart drugs, eight of the ten "experts" who evaluated Aggrastat had conflicts of interest concerning the same.

Things are not expected to get better immediately:

As required by an intriguing law approved in 1997, at some point in 2000 the FDA was supposed to add official industry representatives to the already industry-dominated expert panels even though the new reps will not be allowed to vote.

HEALTH FREEDOM NEWS, Vol. 19 NO.1, Jan.2001

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