Who in FDA Approved Prozac?

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Thu, 13 Jan 2005 20:15:18 -0800 (PST)

[sSRI-Research] Who in FDA Approved Prozac?

 

 

 

Memos Display Drug Firms' Optimism

Officials Were Confident FDA Would Back Them On Suicide, Violence

Issues Involving Paxil, Prozac

 

http://www.drugawareness.org/Archives/3rdQtr_2003/record0007.html

 

 

By JACK DOLAN And DAVE ALTIMARI

Courant Staff Writers

 

 

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! "

 

 

 

 

 

 

 

 

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. "