Fwd: [drugawareness] Another Excellent Article Exposing SSRIs

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atracyphd2

Tue, 23 Sep 2003 23:36:01 EDT

[drugawareness] Another Excellent Article Exposing SSRIs

 

 

The Hartford Courant has published an outstanding article on the politics

behind these drugs! It feels so good to see this in the popular press where it

has belonged for so long so that it can be a warning to the public.

 

I am so sick of hearing about their " rigorous trials " that these drugs have

gone through for approval. What that means is that they have to test these

drugs so many times in order to find a group that are healthy enough to handle

the

adverse effects of the drugs long enough to come out with a trial lasting

several weeks where half of the subjects survive! We know LITTLE about any drug

until it is pulled from the market and the government begins to study it. There

is little to no scrutiny at all with any drug until that time and it has

always been that way.

 

What amazes me most in this article is that Dr. Thompson continues to imagine

the Scientologists as the " boogie man " when it was medical studies which

caused the grave concern over SSRIs leading to the 1991 FDA hearing on Prozac.

In

fact it was Eli Lilly that used the Scientologists as a " scapegoat " to draw

attention away from the real issues coming out in medical studies showing

serious dangers with Prozac and other SSRIs. If they still think they can get

mileage out of that story . . . they are delusional themselves!

 

I thank God that these internal documents are coming out to stand as a

witness against their secret acts designed to increase profits at the cost of so

many lives - lives that were clearly expendable to them - all for the love of

money?

 

Why?

 

Can they not even begin to understand the loss to us all. The loss of these

lives were not only a loss to their families, but to all of us as a society. So

much has been lost! - the laughs we will never experience because Phil

Hartman was taken so soon; the music we will never hear because Del Shannon,

Michael

Hutchence, Kurt Cobain, etc. were taken before they were finished singing;

Princess Di was cut short in the good she had left to give to the world; the

school shootings like Columbine took so many young lives; the workplace violence

shootings that have taken so many lives; so many parents who were taken before

finishing the job of raising their children; so many children who we will

never know what great talents they could have shared with us in their lifetimes,

etc., etc., etc.

 

All for the love of money?

 

Clearly, the loss has been much too great! And at times like this, with the

truth coming out after 14 long years of witnessing this carnage firsthand and

doing all in my power to stop it before it happened, it really gets to me!

 

Dr. Ann Blake Tracy,

Executive Director, International Coalition For Drug Awareness

& author of Prozac: Panacea or Pandora? - Our Serotonin Nightmare

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

 

Order Number: 800-280-0730

Website: www.drugawareness.org

 

_

 

 

http://www.ctnow.com/hc-paxil0921.artsep21.story

 

Memos Display Drug Firms' Optimism

 

Officials Were Confident FDA Would Back Them On Suicide, Violence Issues

Involving Paxil, Prozac

 

September 21, 2003

By JACK DOLAN And DAVE ALTIMARI, Courant Staff Writers

 

When federal regulators recently warned that the antidepressant Paxil may

increase the risk of suicide in children, they stunned the medical community and

left thousands of parents wondering whether their children had been exposed to

an unsafe drug.

 

The U.S. Food and Drug Administration's decision also brought legitimacy to

the courtroom arguments of some patients and their families, who have said for

a decade that Paxil, and other antidepressants such as Prozac, can lead to

unexplained violent behavior, including suicide.

 

Those court filings, some of which have been sealed through the efforts of

pharmaceutical industry lawyers, contain internal memos that reveal

manufacturers were sure they had the support of FDA scientists investigating the

drugs'

safety in the early 1990s - long before all the studies on suicide and violence

were complete.

 

While those early studies on Paxil and Prozac did not provide the FDA with

reason to stop the approval process, the memos offer a rare glimpse into the

discussions between federal regulators and the companies whose drugs they were

charged with investigating.

 

In October 1990, for instance, Thomas Donnelly, an executive from Paxil's

maker, SmithKline Beecham, circulated a memo recounting a telephone conversation

with the FDA official performing the government's study of the drug's safety.

That official, Dr. Martin Brecher, asked Donnelly to produce data on a

potential link between Paxil and suicidal thoughts or actions among patients.

 

Donnelly wrote in the memo to his fellow SmithKline executives that Brecher

and the FDA did not " see it as a real issue " and instead considered the

concerns a " public relations problem " for the antidepressant drug makers. The

memo

was written before the data had been reviewed.

 

Brecher has said since that he did, indeed, view the concerns about suicide

as a " real issue " and doesn't think the Donnelly memo fairly characterized the

conversation.

 

" I'm not saying it's untrue. I just don't - it seems to me to be a stronger

statement of what I recall thinking at the time, " Brecher said in a recent

deposition.

 

Donnelly could not be reached for comment.

 

A few months earlier, the name of Brecher's boss, Paul Leber, showed up in a

similar string of memos at Eli Lilly, the makers of Prozac.

 

In July 1990, a Lilly executive circulated an internal memo describing Leber

as the company's " defender " at the FDA, who had helped the company deflect

similar concerns about a link between Prozac and suicide. Leber, then chief of

the FDA's psychiatric drug division, is quoted dismissing press coverage of

suicide concerns as " trivial " - but at the same time asking Lilly to study the

issue because " it will not go away. "

 

The Lilly memo also urges that evidence showing no link between suicide and

Prozac be rushed to Leber because higher-ranking FDA officials were considering

forcing the company to mention the suicide concern on the drug's label.

 

In another internal company memo, Lilly executive Leigh Thompson warned that

a certain FDA fax number might no longer be safe for sending reports to Leber

after it was discovered that other FDA officials also had access to the

machine.

 

Thompson also mentioned a concern about Leber's computer being compromised

and strongly recommended that Lilly rent space in a building next to Leber's

Washington office so secure communication could be ensured.

 

Both Prozac and Paxil weathered the early 1990s uproar about a possible link

to suicide, which was fueled in large part by patients and their relatives who

were deeply mistrustful of psychiatric drugs. Prozac was particularly

unpopular among followers of the Church of Scientology.

 

It was not until this year that data from unpublished clinical trials on

children by Paxil's maker, now called GlaxoSmithKline, convinced British and

American regulators that there was a scientific basis for the concern about

suicide

in teens.

 

" It's a huge breakthrough, " said Jessica R. Dart, an attorney with a Los

Angeles firm that has represented dozens of patients against Paxil's British

maker, GlaxoSmithKline UK. " It almost didn't feel real. They have been denying

this

for years and years. "

 

Those studies were submitted as part of an FDA initiative to review the

effects on teens of all drugs such as Paxil and Prozac, known as selective

serotonin re-uptake inhibitors, or SSRIs.

 

No similar problem was noted with Prozac, which has since been approved for

use in children, FDA spokesman Brad Stone said.

 

Critics charge that pro-industry attitudes among regulators prevented a more

thorough examination in the early 1990s.

 

Months after the Donnelly memo was written, Brecher filed a key safety report

with the FDA that concluded there was no link between Paxil and an increased

risk of suicide. In October 1992, a panel of doctors convened by the FDA voted

unanimously to approve Paxil after a presentation of Brecher's findings and a

similar presentation by a doctor employed by Glaxo.

 

Brecher wasn't around to make the presentation personally. Shortly after

submitting his report, he quit his government job and went to work for a

European

drug company, advising it on how to get its products approved in the United

States.

 

" Brecher was in a hurry to get the report done before he left the FDA, and he

didn't look at things as closely as he should have, " said Dr. David Healy, a

British psychiatrist and well-known SSRI critic. Healy has served as an expert

witness in several U.S. court cases against the drugs' manufacturers.

 

" That's nonsense, " Brecher said in a recent interview. " I wasn't rushed. And

the review was finished before I even interviewed for the other job. "

 

Brecher said he can't recall the specifics of his conversation with Donnelly,

but he dismissed any interpretation of the memo that suggests too much

camaraderie between the regulators and the pharmaceutical industry.

 

" There certainly was a public relations aspect to it. That's a given, "

Brecher said of the atmosphere surrounding SSRI approval in the early 1990s.

 

Brecher said he did not believe that there was any scientific evidence of a

link to suicide in the clinical trials being done on adults at the time.

 

In 2001, the Donnelly/Brecher memo became evidence in a Wyoming case in which

Glaxo was ordered to pay $6.4 million to the surviving family members of a

man who shot and killed his wife, his daughter, his granddaughter and himself

after beginning treatment with Paxil.

 

Last March, Brecher sat through a seven-hour deposition in a separate case

filed in California involving patients who claim they became addicted to Paxil.

Of all the topics covered, Brecher's discussion of the Donnelly memo is the

only section of the transcript Glaxo lawyers insisted be kept confidential.

 

Glaxo's attorneys supplied The Courant with a copy of the deleted part of the

deposition when questioned about why they fought to keep the memo secret. In

it, Brecher testifies that in his conversation with Donnelly he might have

been referring to concerns over a possible link between anti-depressants and

violence, not suicide, as the issue the FDA did not take seriously.

 

He said he couldn't be sure, because his memory of the conversation was hazy.

 

Like Brecher, Leber has left the FDA. He now owns a private consulting firm

that helps pharmaceutical companies get their drugs approved. Reached by

telephone recently, he refused to discuss his work with the FDA.

 

None of the recent unpublished Glaxo studies linked a suicide to Paxil,

according to Andrew Bayman, an Atlanta lawyer hired by Glaxo to defend it

against

lawsuits.

 

The nine studies were conducted between late 1998 and fall 2002, said Glaxo

spokeswoman Mary Ann Rhyne. The studies looked at more than 1,000 patients

under the age of 18. In total, they showed that 3.4 percent of children who were

taking Paxil, or recently stopped, had attempted suicide or thought more about

it. That compared with 1.2 percent of the children taking a placebo, Rhyne

said.

 

All the data used in the early 1990s to assess the drug's safety looked at

adults, Bayman said, explaining why the teen issue might have passed unnoticed.

 

Paxil became the drug of choice for treating depression in teens because many

of its side effects are relatively mild compared with those of other

medications, said Dr. Patricia Leebens, director of psychiatry for the

Connecticut

Department of Children and Families. Common side effects are nausea, dizziness

and abnormal vision.

 

The DCF recently became the first public child-protection agency in the

country to stop giving Paxil to children after the FDA's recommendation.

 

" This is not a decision that was made lightly. There are many members of the

committee who have had cases where Paxil had done wonders for a patient, "

Leebens said.

 

The DCF also took the anti-depressant Effexor off its list of approved drugs

after the drug's maker, New Jersey-based Wyeth Pharmaceuticals, sent a letter

to doctors warning about a similar link to suicidal thinking among teens.

 

Leebens would not say how many of the nearly 8,000 children in DCF care were

on Paxil, Effexor or other anti-depressants.

 

A spokesperson for Lilly said Prozac went through rigorous trials when it was

approved for adults in the late 1980s, and again more recently when it was

approved to treat obsessive-compulsive disorder and depression, specifically in

children. Prozac is the only SSRI approved by the FDA for treating children,

Lilly spokesperson Jennifer Yoder said.

 

The now-retired Lilly executive, Leigh Thompson, acknowledged calling Leber

the company's " defender, " particularly against attacks by the Church of

Scientology, which was lobbying to get Prozac off the market.

 

Thompson said he talked with Leber as often as three times a week during the

controversy and always ordered his scientists to produce whatever studies the

FDA wanted.

 

" Paul Leber was our defender against all of the attacks in the media, " he

said. " The Scientologists were really after us, and the simplest thing for [the

FDA] to do would have been to pull it off the market - and they didn't. "

 

 

 

 

 

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