Wyeth maker of Effexor pitted against the FDA. ..Rep. Greg Walden, R-Oregon.

[Guest guest]

........... " Wyeth Pharmaceuticals found itself pitted against the FDA.

As early as 2002, Wyeth attempted to add warning labels to its

antidepressant Effexor, but ran into FDA opposition. The ultimate

label changes mandated by the FDA dropped references to increased

hostility seen with Effexor, Wyeth acknowledged under questioning

from the panel's vice chairman, Rep. Greg Walden, R-Oregon.

Adopting FDA's wording was a " reasonable compromise, " Dr. ph

Camardo, senior vice president of medical affairs for Wyeth,

testified.

Earlier in the hearing, Walden asked Dr. Janet Woodcock, FDA deputy

commissioner for operations, whether the agency pressured drug

companies to not issue such warnings.

Woodcock began to say the agency cannot compel companies to reveal

information about clinical trials for drugs pending review.

Walden interrupted. " But some of them have asked you for the ability

to release that information, and you said no. "

" I don't have information on that, " Woodcock said. ........... "

http://www.cnn.com/2004/HEALTH/conditions/09/10/antidepressants.child

ren.ap/index.html

Members of Congress blast FDA, drug makers

Friday, September 10, 2004 Posted: 10:49 AM EDT (1449 GMT)

WASHINGTON (AP) -- Drug manufacturers acknowledge they face a crisis

of credibility that they hope to remedy by releasing information

about their clinical trials in multiple locations.

But at a contentious congressional hearing Thursday, representatives

of the companies said they also are concerned that releasing all of

the information will be so unwieldy that it could confuse doctors

and patients.

Dr. R. , product team leader at Eli Lilly and Co., said a

single report about a drug can number more than 400,000 pages.

Flooding a Web site with 120,000 clinical trials may dilute the

usefulness of the information, said Dr. Wheadon, senior vice

president of regulatory affairs for Philadelphia-based

GlaxoKline. " We always want to make sure we're serving the

good, the right purpose, " he said.

The pair testified at a House subcommittee hearing designed to give

seven drug companies an opportunity to explain how they did -- or

did not -- disclose studies that suggested links between

antidepressant use and suicidal thoughts in children.

Controversy first flared last summer with the disclosure that

unpublished studies made that link.

" I think these hearings are evidence of the fact there is a great

deal of mistrust, " told reporters during a break.

Federal health officials are preparing stronger warnings for some

antidepressants used in children. But exactly what those warnings

will say, and which drugs will be affected, hasn't been settled. An

FDA advisory committee will consider the issue next week.

" While there remains a signal of risk ... for some drugs in some

trials, it is important to note that the data are not black-and-

white in providing a clear and definitive answer, " Food and Drug

Administration psychiatric drugs chief Dr. Laughren wrote the

advisory panel last month.

At the House subcommittee on oversight and investigations hearing

Thursday, tempers flared, tears flowed and a major drug company

Wyeth Pharmaceuticals found itself pitted against the FDA.

As early as 2002, Wyeth attempted to add warning labels to its

antidepressant Effexor, but ran into FDA opposition. The ultimate

label changes mandated by the FDA dropped references to increased

hostility seen with Effexor, Wyeth acknowledged under questioning

from the panel's vice chairman, Rep. Greg Walden, R-Oregon.

Adopting FDA's wording was a " reasonable compromise, " Dr. ph

Camardo, senior vice president of medical affairs for Wyeth,

testified.

Earlier in the hearing, Walden asked Dr. Janet Woodcock, FDA deputy

commissioner for operations, whether the agency pressured drug

companies to not issue such warnings.

Woodcock began to say the agency cannot compel companies to reveal

information about clinical trials for drugs pending review.

Walden interrupted. " But some of them have asked you for the ability

to release that information, and you said no. "

" I don't have information on that, " Woodcock said.

The panel's acting chair, Rep. Joe Barton, R-Texas, had already

sharply criticized the FDA for what he described as the agency's

reluctance to release records, which he said hampered the

subcommittee's ability to investigate.

Because of the volume of records, the FDA had offered to have

records reviewed at the agency, an offer that still stands, Woodcock

said.

Subcommittee members said the FDA and drug companies have provided

scant details of pediatric clinical trials for antidepressants. And,

when the agency last month did publish five summaries, it did not

include crucial details, such as links between antidepressants and

heightened suicidal thoughts among children, said Rep. Bart Stupak,

D-Michigan.

Stupak has been a harsh critic of the acne drug Accutane since his

son committed suicide while using the drug, which has been linked to

depression in some people.

Reps. Markey and Henry Waxman will propose legislation that

would create a mandatory registry for drug trials. The drug industry

this week also announced a new Web site where companies could

voluntarily summarize clinical trial results for drugs approved by

the FDA.

Among the potential legislative solutions being considered by the

panel: Resuscitating an amendment from Stupak requiring clinical

trial publication and label changes before drug manufacturers

receive six-month patent extensions for drugs they test in children.

Such exclusive marketing to children yielded an extra $4 billion for

drug makers of such leading antidepressants as Prozac, Zoloft,

Paxil, Luvox, Celexa and Effexor, data released by the committee

indicates.

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