[SSRI-Research] Glaxo to release data on antidepressant trials

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Sat, 12 Jun 2004 21:02:17 -0000

[sSRI-Research] Glaxo to release data on antidepressant trials

 

Glaxo to release data on antidepressant trials

 

Friday, June 11, 2004

 

BY ED SILVERMAN

 

Newark (New Jersey) Star-Ledger Staff

 

Stung by criticism of its handling of clinical-trial studies,

GlaxoSmithKline yesterday said it will soon release summaries of

safety and effectiveness data of its antidepressant pill in children

under the age of 18.

 

The move comes one week after New York Attorney General Eliot Spitzer

filed a civil lawsuit accusing the British drug maker of fraud for

allegedly withholding negative information about its Paxil drug.

Glaxo was accused of failing to tell doctors that some studies showed

Paxil did not work in teenagers and may lead to suicidal thoughts.

 

In a novel attempt to regulate the pharmaceutical industry, the

lawsuit highlighted a growing controversy over the availability of

clinical-trial data. Currently, there is no requirement that a drug

maker publish or disseminate all of its data. But industry critics

say the lack of disclosure allows negative information to be

suppressed.

 

The issue is an outgrowth of the ongoing debate over antidepressants

and whether the drugs are linked to suicide. The Food and Drug

Administration commissioned researchers to review studies and side

effect reports, and asked drug makers to issue stronger warnings on

product labels. Last year, U.K. regulators urged doctors to write

fewer prescriptions.

 

Other companies that make these pills include Wyeth, Pfizer and

Lilly. But Glaxo, in particular, has generated criticism over an

internal 1998 memo, which indicates the drug maker intended to manage

the release of

clinical-trial data in order to " minimize any potential negative

commercial impact. "

 

In a statement yesterday, Glaxo maintained that clinical-trial data

on Paxil has already been provided to U.S. and U.K. regulators. The

company also reiterated earlier comments that data has been made

available previously to doctors through publication in medical

journals or poster presentations at scientific meetings. Glaxo called

this approach " standard practice. "

 

But in order to " clarify the nature of these data, " Glaxo will make

summaries of Paxil safety and effectiveness data available " shortly "

on its Web site, which is www.gsk.com.

 

In an interview earlier this week with the Daily Telegraph, the

British newspaper, Jean-Pierre Garnier, Glaxo's chief executive,

denied acting on the instructions in the memo.

 

" Of course we didn't follow this advice, " he said. " We didn't

selectively publicize the data. This is not a smoking gun.

 

" It's a stupid memo, and there are lots of stupid memos in every

company's file and it is really unfair to look at the company's

actions through the small hole of one memo written among thousands

and thousands in 1998. I do regret that those memos exist, but I'm

not going to lose sleep over the fact. "

 

http://www.nj.com/business/ledger/index.ssf?/base/business-

0/1086929559244490.xml

 

 

 

 

 

 

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