NEWS - FDA to boost conflict disclosure

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Analysis: FDA to boost conflict disclosure

By Todd Zwillich Jul 25, 2006, 3:26 GMT

WASHINGTON, DC, United States (UPI) -- The Food and Drug Administration

announced Monday it would streamline its process for identifying and

disclosing the conflicts of interest of experts responsible for advising the

agency on new drugs and medical devices.

FDA officials said they would move to reduce what some critics have charged

are arbitrary methods for evaluating and revealing advisors` financial

relationships with industry. Criteria for evaluating and adjudicating

conflicts of interest would now be put in writing and closely followed, the

agency said.

FDA announced it was also launching an internal review of how expert

advisors are chosen and used at FDA.

The changes come amid months of criticism of widespread conflicts of

interests by scientists who consult with the FDA and who publish articles in

medical journals. Several publications, most notably JAMA, have recently

clashed with researchers who they accused of failing to comply with

disclosure standards prior to authoring published articles.

FDA frequently uses panels of outside experts to advise it on the safety and

effectiveness of new drugs or medical equipment up for approval. The experts

are often scientists who have used industry money to conduct research on the

products under review, or have served as paid consultants or speakers for

companies or their competitors.

Still, while pledging to increase the transparency of its disclosures, the

agency did not back away from its contention that experts with ties to

industry can continue to be allowed to participate on advisory panels.

Gottlieb, FDA`s deputy commissioner, said that experts are asked to

advise the agency on what safety restrictions to place on drugs and how to

track them once they are on the market.

'That`s the kind of advice you can only get form people who are heavily

engaged in clinical trials,' he told reporters. 'Clinical trialists are

going to have relationships' with industry, he said.

Now the agency grants waivers to experts with conflicts if the conflicts are

thought to be unlikely to impact their scientific advice.

Gottlieb said that the agency intends to be 'much more transparent' about

how it evaluates and discloses experts` financial ties.

But Nissen, interim chair of the department of cardiovascular

medicine at the Cleveland Clinic Foundation and a long-time FDA advisor,

suggested that the new rules don`t go far enough in guaranteeing confidence

that public product reviews are free of bias.

Nissen warned that FDA is already thought by consumers to be riven with

industry and political influence. 'The American people no longer trusts the

FDA to protect their health,' said Nissen, who is also president of the

American College of Cardiology.

'The appearance of a conflict of interest is as serious as the conflict

itself, because it undermines the public trust,' he said.

Merrill Goozner, director of the Integrity in Science Project at the Center

for Science in the Public Interest, argues that there are plenty of

scientists at government agencies and universities who could advise the

agency on scientific matters.

'These people are out there, if the FDA would just make an effort to go out

and find them,' he said.

'We believe we need to have top thought leaders,' Gottlieb said. 'This band

of heavy clinical trialists is really a narrow band in our country.'

http://news.monstersandcritics.com/health/article_1183703.php/Analysis_FDA_to_bo\

ost_conflict_disclosure

Not an MD

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org