Ethics Newsline®

NEW YORK
British drug maker GlaxoSmithKline, under fire for allegedly concealing negative research about its popular drug Paxil, last week agreed to make the data public and pay $2.5 million to New York State.

The settlement comes after New York Attorney General Eliot Spitzer sued the company in June for fraud, accusing it of burying test results that indicated an increase in suicidal tendencies in children taking Paxil.

Of at least five research studies on Paxil and children, Glaxo released the findings of only one, which showed mixed results, reported the Associated Press.

Spitzer and others say the company deliberately suppressed the other tests’ negative results, skewing both public perception and doctors’ prescriptions, and endangering the lives of depressed teens.

While Glaxo insists it made all of the data public, an internal 1999 document said the company planned to “manage the dissemination of data in order to minimize any potential negative commercial impact,” according to the AP.

Glaxo said its settlement last week was simply the most expedient way to end the lawsuit, denying wrongdoing and claiming that it had been planning all along to release the negative data.

The settlement calls on Glaxo to post all of its Paxil data to the web by December 2005. Test results from now on will be posted within 10 months of a drug’s approval, Glaxo spokeswoman Nancy Pekarek told the AP.

Spitzer’s office last week said the settlement sets a “new standard with regard to disclosure of clinical studies” — one the state hopes other drug makers will follow, increasing transparency and trust.

If they fail to follow suit, more lawsuits are likely, Spitzer’s health care bureau chief, Joe Baker, told the AP. “We will continue to do that until we feel this industry as a whole has stopped this practice,” he warned.

Spitzer last week saved some of the blame for the U.S. Food and Drug Administration (FDA), slamming the agency for failing to require such steps, reported the New York Times.

“We’re asking where has the FDA been all these years when clinical data has been hidden from public scrutiny?” complained Spitzer. “They have simply failed to confront the problem.”