Prozac: How Lilly Gilded Prozac's Profile: the Street.com

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Tue, 10 May 2005 21:49:49 -0400

[sSRI-Research] Prozac: " How Lilly Gilded Prozac's Profile " :

the Street.com

 

 

 

This article states: " Worried health care experts have long attempted

to make this evidence known, but they have found themselves drowned

out, and even attacked, by powerful scientists with close ties to the

drug industry. "

 

" Among those being tainted, it included organizations that portray

themselves as consumer groups but are financed by the drug industry. "

 

http://www.thestreet.com/_googlen/stocks/melissadavid/10222483.html?cm_ven=GOOGL\

EN & cm_cat=FREE & cm_ite=NA

 

How Lilly Gilded Prozac's Profile

 

By Melissa Davis

Senior Writer

5/10/2005 7:16 AM EDT

 

This spring, Jeff Weise shot himself dead after taking the popular

antidepressant Prozac.

 

He scored national headlines because he took nine innocent people down

with him in the worst school shooting rampage since Columbine. Some

now wonder whether Weise's antidepressant -- rather than depression

itself -- may have finally pushed the troubled teenager over the edge.

After all, unstable Prozac users have been pulling the trigger for years.

 

Joseph Wesbecker killed himself and eight others while taking Prozac

back in the late 1980s, when the still-new drug was viewed as a

miracle cure for depression. Relatives of the survivors blamed Prozac

and sued its maker, Eli Lilly ( LLY:NYSE - commentary - research), for

damages. That case, which ended in a settlement, began to expose

serious problems with drug research that have grown even more obvious

over time.

 

By now, internal documents have surfaced highlighting concerns about

drugs like Prozac -- known as selective serotonin reuptake inhibitors,

or SSRIs -- that date back to their early clinical trials. Worried

health care experts have long attempted to make this evidence known,

but they have found themselves drowned out, and even attacked, by

powerful scientists with close ties to the drug industry.

 

In this second installment of a five-part series examining conflicts

in the drug industry, TheStreet.com examines how big pharmaceutical

companies -- heavy on marketing know-how but increasingly strapped for

big-selling new drugs -- pressed the popular antidepressants into

service in spite of lingering questions over their safety.

 

The drug companies continue to stand behind their blockbuster

antidepressants and market them to the masses. And they keep raking in

billions of dollars in profits -- more than any other industry -- as a

result of their success.

 

But prestigious medical journals, including those that regularly

publish research by the well-connected scientists, have called for

ethical reforms. So have consumer watchdog groups. Industry critics

insist that drugmakers exert too much influence over researchers,

consumer groups and even the government agency charged with regulating

them.

 

As a result, the big pharmaceutical houses' reputations -- and their

share prices -- have begun to take a hit. Shares of Eli Lilly, which

now has two major antidepressants on the market, have lost a quarter

of their value over the past year. Shares of Pfizer ( PFE:NYSE -

commentary - research), which makes bestseller Zoloft, have fallen by

a similar amount.

 

 

David Healy, a noted British psychiatrist and author of Let Them Eat

Prozac , has taken aim at Prozac and its competitors alike.

 

" I happen to believe that Prozac and other SSRIs can lead to suicide, "

Healy said at a 2000 university conference that would go on to spark a

huge controversy. " These drugs may have been responsible for one death

for every day that Prozac has been on the market in North America. In

all likelihood, many of you will not agree with me on this -- [but]

you haven't seen the information that I have seen. "

 

Eli Lilly was quick to defend its own drug.

 

" While reasonable physicians may differ in their opinions of the

safety and effectiveness of a given medication -- or even a class of

medications -- the fact is that Prozac has been approved for use by

medical regulatory agencies in 120 countries worldwide, " the company

told TheStreet.com. " Additionally, Prozac has been credited by

millions of patients and their families with improving their lives.

These facts speak to the overall safety of the product. "

 

But clinical trial data, normally unavailable to the general public,

has come to light, exposing serious problems with the drugs. In one

drug trial, documents obtained by CNN show, some 3.7% of Prozac users

attempted to commit suicide. The same study shows that less than 1% of

participants on non-SSRI depressants engaged in the same behavior.

 

Trials of Zoloft have raised questions about the effectiveness of

SSRIs as well. In a 1991 letter prior to the drug's approval, the Food

and Drug Administration noted that two separate studies had shown

Zoloft to be no more effective than placebo. The agency admitted that

the evidence supporting Zoloft was " not as consistent or robust as one

might prefer it to be. " But it went on to say that such facts were

" insufficient to undermine " approval of the drug.

 

Still, Pfizer itself was apparently worried.

 

" Pfizer's depression program has in fact demonstrated a roughly 50%

failure to demonstrate efficacy in clinical trials, a great number of

which remain unpublished, " Healy wrote in a letter last summer to the

FDA. " So poor were the results from the early trials that they raised

concerns that this drug might not get through the regulatory authorities. "

 

Not only did Zoloft often prove ineffective, Healy said, but the drug

-- like other SSRIs -- seemed to heighten suicide risks as well. On

multiple occasions, he said, clinical investigators linked Zoloft to

suicidal tendencies.

 

" The evidence that Zoloft works is, in many respects, less strong than

the evidence it causes suicidal behaviors, " Healy concluded.

 

Pfizer didn't answer questions about the drug for this story.

 

To be sure, Healy has taken plenty of heat for his views. Most

notably, he lost out on a prestigious job at the University of Toronto

shortly after his controversial presentation in 2000. The university,

which operates a big mental health center funded in part by the maker

of Prozac, abruptly withdrew its offer to Healy because it no longer

felt his approach was " compatible with the goals for development of

the academic and clinical resource " at the school. Even now, Healy

told the FDA, at least one public relations firm working for an SSRI

maker specifically lists him as a " problem to be managed. "

 

 

Healy points to Charles Nemeroff, a psychiatrist with numerous

industry ties, as an especially fierce foe. Others have found reason

to single out Nemeroff as well. Nemeroff himself failed to return a

phone call from TheStreet.com.

 

" Dr. Charles B. Nemeroff may hold some sort of record among academic

clinicians for the most conflicts of interest, " the Washington Monthly

wrote last year. " A psychiatrist, a prominent researcher and chairman

of the department of psychiatry and behavioral science at Emory

University in Atlanta, Nemeroff receives funding for his academic

research from Eli Lilly, AstraZeneca ( AZN:NYSE - commentary -

research), Pfizer, Wyeth ( WYE:NYSE - commentary - research) -- indeed

from virtually every pharmaceutical house that manufacturers a drug to

treat mental illness. He also serves as a consultant to drug and

biotech companies, owns their stocks and is a member of several

speakers' bureaus delivering talks -- for a fee -- to other physicians

on behalf of the companies' products. "

A recent U.K. investigation, reported by TheStreet.com Monday, raised

serious concerns about so-called key opinion leaders with financial

ties to the drug industry. The study suggested that drugmakers

exercise far too much influence over those who go on to promote their

products.

 

Among those being tainted, it included organizations that portray

themselves as consumer groups but are financed by the drug industry.

Healy personally warned about the groups in his conference

presentation years ago.

 

" Part of the market development plans for many drugs these days

includes the creation of patient groups to lobby on behalf of a new

treatment, " he said back then. " The most vigorous and hostile patient

groups of the anti-psychiatry period have been penetrated by the

pharmaceutical industry. (And) other patient groups have been set up

de novo by companies. "

 

Others have highlighted major industry problems as well. In 1999, for

example, the prestigious Journal of the American Medical Association

called for " fair conduct and fair reporting of clinical trials. " By

then, the New England Journal of Medicine -- yet another influential

publication -- had already laid out the need for protecting those who

do come forth with negative study results. More recently, American

Psychologist has specifically suggested " building a firewall between

marketing and science " in the mental health field where SSRIs are so used.

 

David Antonuccio, a medical researcher who penned the third article,

is hoping that psychologists -- faced with prescribing powers in the

future -- will do a decent job of policing themselves. After studying

past actions by federal regulators, he seems to have little faith in

the FDA at all.

 

" At 55% of the meetings, half or more of the FDA advisers had

financial conflicts of interest, " he wrote. " Although federal law

generally prohibits the use of experts with financial conflicts of

interest, the FDA waived this restriction more than 800 times " in less

than three years.

 

 

Sen. Charles Grassley, a powerful Republican from Iowa, has challenged

the FDA's handling of SSRI issues in particular. Just after a major

FDA hearing last year, Grassley launched an investigation of the

agency for allegedly concealing risks associated with the drugs.

 

Healy, on his own, volunteered some details about the matter when

submitting testimony for the recent U.K. investigation. Ten days

before the FDA hearing, he said, three noted psychiatrists -- who

authored most of the trial literature on SSRIs -- came forth and

declared that the drugs were " safe and effective and well-tolerated by

children, " even though they had never seen the raw data on which their

findings were supposedly based. But despite this " pre-emptive strike, "

Healy noted, the FDA did go on to demand stronger warning labels for

childhood use of the drugs.

 

By then, however, the drugs had already soared in popularity. A

government study published last year showed that children who visited

the doctor for depression symptoms were nearly three times as likely

to wind up on prescription drugs (usually the newer SSRIs) than they

were a decade ago. Moreover, it indicated that adults -- including 13%

of women aged 45 to 64 -- were turning to the drugs as well.

 

Healy has pointed to drugmakers, which spend far more promoting their

products than they do developing them, as the drivers behind that trend.

 

" Corporations work out what they have to sell and then prepare the

market so that we will want those products, " he warned years ago. " It

works for cars, oil and everything else. Why would it not work for

psychiatry? "