Sales Reps Told Not To Divulge Paxil Hostility & Suicide

[Guest guest]

atracyphd2

Wed, 29 Sep 2004 21:08:12 EDT

 

 

Sales Reps Told Not To Divulge Paxil Hostility & Suicide

Risks To Youth

 

 

A breaking news story today out of the Star Ledger reported that Glaxo

has been busy keeping more dirty secrets (as if anyone did not know

that already) from everyone - especially from the physicians who

needed it most in order to protect their patients.

 

This is an amazing revelation in light of the fact that what these

companies are being sued for more than most anything else is " failure

to warn. " Does it sound to you as though they are intimidated at all

when it comes to lawsuits?

 

I also wonder how these drug reps sleep at night when they know about

this increased risk of hostility and suicide in children and are being

asked not to reveal it to doctors. How does someone ethically do that?

Surely they could find a respectable job somewhere. . . .

 

Dr. Tracy

______________

 

Ann Blake Tracy, Ph.D.,

Executive Director, International Coalition For Drug Awareness

Author: Prozac: Panacea or Pandora? - Our Serotonin Nightmare & audio

tape on safe withdrawal: " Help! I Can't Get Off My Antidepressant! "

Order Number: 800-280-0730

Website: www.drugawareness.org

______________

 

 

In a memo last September, GlaxoSmithKline provided an update on

concerns over its Paxil medicine, including study results showing a

high incidence of suicide and hostility, but instructed its sales

representatives in bold letters not to " discuss the contents " with

doctors.

 

http://www.nj.com/news/ledger/index.ssf?/base/news-17/1096436354137050.xml

 

 

Sales reps told not to divulge Paxil data

 

Drug maker memo cited risks to youth

 

Wednesday, September 29, 2004

BY ED SILVERMAN

 

Just as the safety of antidepressants became a controversy last year,

one drug maker told its sales force not to talk to doctors about data

linking its pill to serious side effects in children and adolescents.

 

In a memo last September, GlaxoSmithKline provided an update on

concerns over its Paxil medicine, including study results showing a

high incidence of suicide and hostility, but instructed its sales

representatives in bold letters not to " discuss the contents " with

doctors.

 

The memo, a copy of which was obtained by The Star-Ledger, comes to

light after months of criticism of the pharmaceutical industry for

allegedly withholding important clinical-trial data that cast

antidepressants in a negative light.

 

 

Last month, Glaxo agreed to disclose trial data about its drugs to

settle a lawsuit filed by the New York attorney general, who accused

the company of fraud for concealing negative results about Paxil.

Congress, meanwhile, is also investigating the allegations.

 

A Glaxo spokeswoman denied any attempt to conceal information from

doctors.

But ethics experts questioned the drug maker's intentions.

 

" I'm confused about the motive and my first instinct is to be

suspicious, " said Norman Fost, a pediatrics and medical ethics

professor at the University of Wisconsin, and a member of a federal

advisory panel that recently recommended severe warnings for

antidepressants.

 

" It's not transparent, " he said. " If the company sincerely wanted

doctors to know about the risks of prescribing Paxil for children and

adolescents, distributing the (clinical-trial) articles would have

been the way to do that. "

 

Glaxo spokeswoman Mary Anne Rhyne said the sales reps were instructed

not to speak with doctors about the clinical-trial results because

drug companies are forbidden from engaging in any activity that may be

considered off- label promotion.

 

" Our sales reps are prohibited from discussing, sharing or leaving

behind off-label information with health care providers, " she said.

 

Off-label refers to promoting or prescribing a drug for a use not

approved by the Food and Drug Administration. Among antidepressants,

only Prozac has been approved for use in children and adolescents,

although doctors are free to prescribe as they choose.

 

Another medical ethics expert said drug company sales reps should not

promote off-label usage, but argued Glaxo had an obligation to inform

doctors of negative trial data to protect patients.

 

" You don't want to hide under the off-label excuse, " said Arthur

Caplan of the Center for Bioethics at the University of Pennsylvania.

" They do have a moral duty. "

 

Off-label prescriptions for those younger than 18 accounted for 8

percent of all antidepressant prescriptions during the first six

months of this year, said Michael Evans of the FDA Office of Drug

Safety, at an agency advisory meeting two weeks ago.

 

At that two-day session, the FDA advisory panel sat through

presentations showing the drugs, as a group, are twice as likely as a

placebo -- or dummy pill -- to cause suicidal thoughts or behavior in

children. The drugs were also shown to be ineffective in children.

 

As a result, the panel recommended the FDA issue " Black Box " warnings,

prominently placed on package inserts in hopes of quickly capturing

the attention of doctors and patients. The FDA, which is also

reviewing data on adults, may take action as early as this week.

 

In its September 2003 memo, U.K.-based Glaxo said pediatric trials

involving Paxil did not find any patients who committed suicide.

However, there has since been controversy over the way the company

described such behavior, which prompted regulatory review of the data.

 

The memo included results from a study, known as 329, which concluded

Paxil was safe and effective in youngsters. However, the study has

since been questioned by critics, who note that 7.5 percent of

patients suffered emotional liability, which refers to suicidal

activity, versus 0 percent on placebo. Also, 6.5 percent experienced

hostility versus 1 percent on placebo.

 

" This letter is for your informational purposes only, " the memo said.

" Although you should read the letter carefully, please do not discuss

the contents with your customers. "

 

The Glaxo spokeswoman said the study was published in the Journal of

the American Academy of Child and Adolescent Psychiatry in July 2001

and was widely circulated.

 

David Fassler, a University of Vermont psychiatry professor and

trustee of the American Psychiatric Association, said many child

psychiatrists should have seen the article. But he also said the

journal is " not necessarily read by many pediatricians and

primary-care physicians. "

 

 

Ed Silverman can be reached at (973) 392-1542 or esilverman