NY State Sues Drug Giant on prescribing its antidepressant Paxil to children

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NY State Sues Drug Giant

 

WASHINGTON, June 3, 2004

http://www.cbsnews.com/stories/2004/06/03/health/main620815.shtml

 

 

Anti-Depressants & Suicide

 

 

New York State Attorney General Eliot Spitzer, who has fought closed-door

Wall Street deals that left ordinary investors in the dark, says drug

companies need to make their research more public. (Photo: AP)

 

 

 

In March, the FDA said doctors should monitor closely all patients taking

antidepressants for signs of suicidal behavior. It also asked the makers of

10 such drugs to add or strengthen suicide-related warnings to their labels.

 

 

 

(AP) GlaxoSmithKline PLC committed fraud by withholding negative information

and misrepresenting data on prescribing its antidepressant Paxil to

children, according to a lawsuit filed Wednesday by New York Attorney

General Eliot Spitzer.

 

The lawsuit highlights two pharmaceutical and medical controversies: whether

antidepressants increase suicidal tendencies in children, and if drug

companies skew information on their products either by not publicizing all

the studies conducted on medicines or editing information on published

trials.

 

" Having doctors prescribe drugs without full knowledge of safety and

efficacy is wrong, " Spitzer said.

 

Filed in New York State Supreme Court, the suit said Glaxo suppressed four

studies that failed to demonstrate the drug was effective in treating

children and adolescents and that suggested a possible increase in suicidal

thinking and acts.

 

It also said an internal 1999 Glaxo document showed that the company

intended to " manage the dissemination of data in order to minimize any

potential negative commercial impact. "

 

Glaxo spokeswoman Mary Anne Rhyne said the company " acted responsibly in

conducting the studies in pediatric patients and disseminating results. All

of our studies have been made available to the (U.S. Food and Drug

Administration) and regulators worldwide. "

 

Rhyne also said the studies have been made public in medical meetings,

journals and letters to doctors. She said the internal document is

" inaccurate " and " doesn't express the overall company position. "

 

Only Prozac, made by Eli Lilly & Co., has been approved to treat depression

in children. But doctors can prescribe drugs as they see fit and routinely

recommend such medicines for children suffering from depression and other

psychological disorders.

 

However, evidence showing that antidepressants other than Prozac may not be

suitable for use in children has spurred a movement to force drug companies

to publish all the information they collect on their medicines.

 

Last year, after reviewing Glaxo's pediatric studies on Paxil, British

medical authorities said it should not be used to treat depression in people

under 18 because of concerns about potential suicidal behavior. British

authorities also said most commonly prescribed antidepressants are not

suitable for children because the risks outweigh the benefits.

 

At an FDA meeting in February to discuss suicidal tendencies in children

taking antidepressants, psychiatrist Dr. David Fassler said he was given

data and studies he'd never seen before.

 

" That raised a lot of questions, " said Fassler, who is on the board of the

American Psychiatric Association. " As a physician, the easier the access to

data, the more helpful I can be to my patients. "

 

Fassler said the data he saw didn't show a clear association with suicidal

behavior. " More dramatic was how few drugs demonstrated any efficacy, " he

said, and added that poor study design may have played a role in that.

 

In March, the FDA said doctors should monitor closely all patients taking

antidepressants for signs of suicidal behavior. It also asked the makers of

10 such drugs to add or strengthen suicide-related warnings to their labels.

The FDA has commissioned a study to review previous pediatric clinical

trials of antidepressants to search for signs of suicidal behavior, and the

results are expected this summer.

 

Meanwhile, doctors are seeking ways to improve the veracity of studies

published in journals and improve access to clinical trials conducted by

drug companies.

 

A report prepared for the policy-making body of the American Medical

Association recommended that the Department of Health and Human Services

create a registry of all clinical trials.

 

The AMA policy body is set to vote in two weeks on that proposal, which is

intended to improve doctors' access to potentially valuable data on drugs

they are considering prescribing for their patients.

 

Currently, drug companies seeking approval for new drugs must give the Food

and Drug Administration the data on all clinical trials. But the data -

considered to be private property - is not made public by the government,

which upon approval, issues only summaries of the information.

 

The AMA report also recommends journal editors take steps to ensure that

articles outline any role the study sponsor had in designing, collecting and

analyzing the data. They should also make sure researchers conducting the

studies can analyze and publish the data independently of the trial sponsor.

 

Some data suggests information from drug studies may not be reliable. Last

month, a Journal of the American Medical Association article that reviewed

102 clinical trials found that 50 percent of efficacy outcomes and 65

percent of harm outcomes were incompletely reported. The article concluded

that trial outcomes are frequently incomplete, biased and inconsistent with

protocols.

 

Currently, when a drug is approved, all the studies reviewed by the FDA to

make its decision are made public. That doesn't happen if a drug or an

application for a new use is rejected.

 

Drug companies receive a six-month patent extension if they study their

treatment in children, whether or not the medicine is approved for pediatric

use. A review of those studies is made public.

 

The companies don't need FDA approval to conduct head-to-head studies

against a competitor's product for approved uses and are under no obligation

to publish them. But doctors say that kind of information would be helpful.

 

" Negative information is a benefit to us, " said Dr. John Sneider, an

internist in Illinois who worked on the report for the AMA.

 

Spitzer said Glaxo's revenues for Paxil prescriptions in children and

adolescents totaled $55 million in 2002. The lawsuit alleges the fraud began

in 1998 and seeks the return of all profits obtained by Glaxo as a result of

conduct alleged in the suit. Paxil was launched in 1993 and has sales of $3

billion last year.

 

Glaxo's U.S. shares fell $1.38, or 3 percent, to close at $41.39 on the New

York Stock Exchange.

 

 

 

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