Conflicts on FDA Panels Detailed

[Guest guest]

At last - the truth is coming out!

We have the best government money can buy . . .

corporate money, of course!

------------------------------

http://www.latimes.com/news/printedition/asection/la-na-fda26apr26,1,7448376.sto\

ry

Conflicts on FDA Panels Detailed

A study finds that more than 25% of experts on

advisory committees have financial links to the drug

industry.

By Alonso-Zaldivar, Times Staff Writer

April 26, 2006

WASHINGTON — More than a quarter of the scientific

committee members who advise the Food and Drug

Administration on crucial decisions affecting such

products as cancer drugs and breast implants have

financial ties to industry, a study published Tuesday

found.

But the analysis in the Journal of the American

Medical Assn. also found that even if the scientists

and physicians with financial ties to industry had

recused themselves from voting, none of the final

results in 221 reviewed meetings would have changed.

Conducted by leading FDA critics, the study was

praised by supporters of the agency as proof that

conflict-of-interest policies, strengthened in 2002 to

require broader disclosure of industry interests, were

working.

Still, Dr. Lurie, the study's lead author and

the deputy director of Public Citizen's Health

Research Group, a consumer advocacy group, said the

findings showed that the FDA should further tighten

its rules. For example, although 28% of committee

members disclosed financial conflicts, only 1% recused

themselves from voting on related issues, a trend

Lurie called unacceptable.

" I don't think it's acceptable to say we're willing to

take any amount of conflict up to the point at which

the overall outcome changes, " he said. " Certainly we

would never accept anything like that in a jury. "

An advisory committee vote can seal the fate of

billions of dollars in potential revenue for drug

companies because the FDA generally follows a panel's

recommendation. Committee members are often physicians

from top universities and teaching hospitals —

institutions that are among the leading recipients of

industry research funds.

FDA rules automatically exclude advisors from a

meeting if they have investments exceeding $100,000 in

a company that is likely to be affected by the result,

or if their investments in such a company exceed 15%

of their net worth. Those with lesser degrees of

conflict may participate but must file a disclosure

form, and any such conflicts are usually noted in an

FDA statement at the start of each meeting.

Most of the financial ties cited in the study were not

particularly large: 80% of the committee members'

consulting agreements were for $10,000 or less; 77% of

research grants were for $100,000 or less; 70% of

investments were $25,000 and under; and 56% of speaker

fees totaled $10,000 or less.

Economist E. Calfee of the American Enterprise

Institute, a business-oriented think tank in

Washington, said the study — although perhaps not the

intent of its authors — showed that most leading

doctors tended to put their professional reputations

ahead of financial interests.

" It is very useful to find out that conflicts of

interest in advisory committee meetings are apparently

not very important, " said Calfee, who sometimes works

as a consultant to industry. " It's always hard to find

unconflicted, top-rate scholars. Academics become

prominent by doing research. And manufacturers need

consultants. So they tend to go after the best

researchers. "

The FDA had no comment on the findings, but issued a

statement saying that its conflict-of-interest policy

was working.

The study focused on consulting agreements, research

contracts, investments and speaker fees. Consulting

agreements were the most common kind of conflict of

interest.

In a majority of meetings, excluding the advisors with

conflicts would have reduced the margin of approval

for the drug that was being considered, the study

found. But it would not have changed the final

outcome, partly because committees were unanimous in

recommending approval.

Lurie, the study's author, said vote totals might be

an imperfect yardstick for conflicts of interest.

" Unfortunately, there is not a simple bottom line, " he

said. " You may not have a conflict, while the person

sitting next to you might. And you may be influenced

by him. "