Prozac Backlash_Fortune Magazine

[Guest guest]

SSRI-Research@

Mon, 5 Dec 2005 08:06:25 -0500

[sSRI-Research] Prozac Backlash_Fortune Magazine

 

 

 

 

Prozac Backlash_Fortune Magazine

 

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

www.ahrp.org

 

FYI

Fortune Magazine reviews the controversy surrounding Prozac and the

SSRI class of antidepressants, acknowledging that " the drugs have been

among the most controversial in the history of medicine. Bitter

disputes about side effects have seethed for more than a decade,

usually out of sight of the mainstream media--in supermarket tabloids,

on websites, and in professional gatherings of scientists, regulators,

and shrinks. " That battle has finally spilled into the major media--

providing the public an opportunity to judge for themselves.

 

The genie is out of the bottle and there is nothing that SSRI drug

manufacturers, or psychiatry's key opinion leaders who serve as

industry's paid consultants, nor government regulators, can do to stem

back the tide of eye opening revelations about suppressed evidence of

adverse effects-in particular, akathisia-so severe that some

people-including children-have been propelled to commit suicide and

even homicide.

 

The financial success of SSRIs--$11 billion in sales-bears no

relationship to positive clinical effects or improved recovery rates,

but rather their success is the result of false claims and fraudulent

marketing. First, the drugs do not " work " by fixing a " chemical

imbalance " in the brain. Indeed, there is no proven chemical or other

physical " imbalance " in the brain of people diagnosed with a mental or

emotional disorder.

 

" A number of scientists have theorized that while boosting serotonin,

SSRIs indirectly inhibit another key neurochemical messenger called

dopamine. That means the drugs may actually create a perilous brain

imbalance in some people. What's more, there's some evidence that

dopamine inhibition underlies several of the rare, serious side

effects linked to SSRIs. One is akathisia, a kind of extreme

restlessness that has been implicated in suicidal impulses--Witczak

believes Zoloft induced akathisia in her husband. " Thus, SSRIs are

may be more hazardous than the older, far cheaper antidepressants

which do not cause akathisia.

 

At the center of the Fortune article, is Kimberly Witczac, whose

husband, Tim " Woody " Witczac, committed suicide after being prescribed

Zoloft for insomnia due to work related stress. Ms. Witczac is putting

up a formidable battle against Pfizer and the other SSRI

antidepressant manufacturers for concealing the evidence of hazardous,

potentially lethal effects. She has testified at congressional and FDA

hearings (most recently this month) to tell of her tragedy and the

dangers of SSRIs. Her lawsuit against Pfizer, Fortune reports, " is

likely to spotlight disturbing information that drug companies and

U.S. regulators have been aware of for years--but that most doctors

prescribing the drugs have known little or nothing about. "

 

A profile of Dr. David Healy in today's New York Times Science

section, " A Self-Effacing Scholar Is Psychiatry's Gadfly, " compliments

the Fortune overview, inasmuch as more than anyone he is responsible

for bringing the long concealed, unpublished evidence about the

hazardous effects of SSRIs to public view. [infomail to follow]

 

See: http://www.nytimes.com/2005/11/15/science/15prof.html

 

 

Contact: Vera Hassner Sharav

212-595-8974

veracare

 

 

http://www.fortune.com/fortune

Fortune Magazine

November 28, 2005

PROZAC BACKLASH

Trouble in Prozac

by: DAVID STIPP

 

Can Prozac make you want to die? The idea seems strange, given that

the drug and similar antidepressants are supposed to do just the

opposite. Yet that is what Kimberly Witczak believes happened to her

husband. Two years ago Tim " Woody " Witczak killed himself at age 37,

soon after going on Pfizer's Zoloft--the top-selling member of

Prozac's class of drugs, known as selective serotonin reuptake

inhibitors, or SSRIs. Her husband was an upbeat, happy man, says Kim

Witczak. Shortly before his death he had been named vice president of

sales at a startup that sold energy-efficient lighting. When anxiety

about the new job caused insomnia, he was prescribed Zoloft. He began

suffering from nightmares, profound agitation, and eerie sensory

experiences after a couple of weeks on the medicine--at one point, she

says, he said he felt as if his head were detached from his body. Then

he seemed to calm down. But about five weeks after his first dose, he

hanged himself from the rafters in their garage when Kim was out of

town. He left no suicide note.

 

" Woody's death was the most out-of-the-blue, out-of-character death, "

she told FORTUNE recently. " He had no history of mental illness. " Kim

Witczak, who lives in Minneapolis, has sued Pfizer, alleging that

Zoloft induced the suicide and that the company failed to warn about

the drug's potential to cause perilous side effects. Pfizer declined

to comment while the case is in litigation, but a spokesman asserted

that there is " no scientifically based " evidence to suggest Zoloft can

induce violent acts. It's not the first time SSRI makers have faced

complaints related to suicide or other forms of violence. They have

fended off or quietly settled scores of such suits over the years

without significant injury to their drugs' reputations.

 

But the Witczak case, which may play out in court next spring, is

likely to put SSRIs on trial as never before. For one thing, Kim

Witczak has emerged as a formidable crusader. Poised and articulate,

she has appeared at congressional and Food and Drug Administration

hearings (most recently this month) to tell of her tragedy and the

dangers of SSRIs. What's more, her suit is likely to spotlight

disturbing information that drug companies and U.S. regulators have

been aware of for years--but that most doctors prescribing the drugs

have known little or nothing about.

 

Controversy about SSRIs' side effects flared into national prominence

last year when they and older antidepressants were shown to double the

risk of suicidal thoughts and behavior in children and adolescents.

That discovery prompted the FDA to slap a stern " black box " warning on

the drugs' package inserts. (Among other things, it cautions doctors

to monitor young patients closely in their first months on SSRIs.)

 

A black-box warning about suicidal thoughts and behavior in adults may

very well be next, say a number of experts interviewed by FORTUNE.

" I'm fully expecting that the same [risk found in young patients] will

be found in adults, " says Dr. Richard Kapit, an ex-FDA official who

handled the agency's first safety review of Prozac before its approval

in 1987. (He now works as a medical writer and consultant in Bethesda,

Md.) In fact, last summer the FDA warned that several recent studies

suggest that SSRIs and other antidepressants raise the risk of

suicidal behavior in adults as well as kids. The agency added that it

is reviewing " all available data " on the issue in an investigation

expected to take a year or more.

 

Risk of suicide isn't the only problem dogging SSRIs. For example,

GlaxoSmithKline faces thousands of lawsuits on another side effect,

severe withdrawal reactions to its drug Paxil, one of the

fastest-acting SSRIs. Last year British policymakers moved to

discourage the use of SSRIs to treat mild depression. And a recent

scientific analysis has challenged long-held assumptions about how the

drugs work. That could undercut drugmakers' assertions that SSRIs are

well understood, potentially increasing doubts about their safety.

 

A black-box warning for adults could have huge repercussions,

vaporizing billions of dollars of future sales, increasing pressure on

policymakers to curtail direct-to-consumer drug ads, and prompting a

slew of lawsuits. It could also complicate drugmakers' efforts to roll

out new antidepressants to replace current ones as the drugs go off

patent. The ultimate fallout could well equal or exceed that from

Vioxx, the Merck painkiller whose saga of potentially lethal risks,

dodgy marketing, and damaging courtroom disclosures has given Big

Pharma the look of an ethical disaster zone. If so, it would add a sad

twist to a tale in which so many people have been helped.

 

Birth of a Blockbuster

 

Prozac and its kin have been one of 20th-century medicine's great

success stories. Since the debut of Eli Lilly's Prozac in 1988, the

drugs have grown into an $ 11-billion-a-year market in the U.S. alone.

Nearly 150 million U.S. prescriptions were dispensed in 2004 for SSRIs

and similar antidepressants called SNRIs, according to IMS Health, a

Fairfield, Conn., drug data and consulting company--more than for any

other drug except codeine. Perhaps one out of 20 adult Americans are

on them now, making brands like Zoloft, GlaxoSmithKline's Paxil,

Forest Laboratories' Celexa, and Solvay Pharmaceuticals' Luvox

household names. Though they don't work for everybody--many people

have gone off the medicines because of side effects such as dampening

of sexual response--they've done more than any other class of drugs to

spur psychiatry's substitution of pills for couches.

 

In fact, we're popping so many SSRIs that their breakdown products in

urine, gushing into waterways, have accumulated in fish tissues,

raising concerns that aquatic animals may be getting toxic doses,

according to recent research at Baylor University.

 

The SSRI phenomenon began almost the minute Prozac appeared. Doctors

embraced the drugs because of a virtue that seems increasingly ironic:

It's hard to commit suicide by overdosing on SSRIs, so they are deemed

safer to give to severely depressed patients than are older, more

acutely toxic antidepressants such as the so-called tricyclics.

Indeed, the drugs once seemed so benign that some psychiatrists

marveled about how they appear to violate the law of " conservation of

mood " --a seemingly universal pattern in which drug-induced emotional

lifts are always followed by crashes, resulting in no net gain. Such

talk made Prozac seem safer than coffee. That paved the way for

massive prescribing by general practitioners with no special training

in complex mental disorders--in recent years some 70% of SSRI

prescriptions have been written by primary-care doctors.

 

Within three years of Prozac's launch, annual sales neared $ 800

million. Newsweek put the pill on its cover--a green-and-white capsule

floating against a blue sky under a headline that hailed it as a

breakthrough drug. Even healthy people were asking for Prozac, the

magazine noted. By 1993 the idea caught on that SSRIs could transform

lives--curing not only depression but also shyness, low self-esteem,

and compulsiveness. Major boosts for the fad came from Listening to

Prozac, psychiatrist Peter Kramer's eloquent bestseller, and from

celebrity endorsements. Recounting his fight with depression, Mike

Wallace of CBS's 60 Minutes told Newsweek he expected to take Zoloft

for the rest of his life.

 

But for all the glow about SSRIs, the drugs have been among the most

controversial in the history of medicine. Bitter disputes about side

effects have seethed for more than a decade, usually out of sight of

the mainstream media--in supermarket tabloids, on websites, and in

professional gatherings of scientists, regulators, and shrinks.

 

Rare, dangerous side effects of potent medicines like antidepressants

often emerge only after the drugs have been prescribed to millions of

people for years. But in the case of SSRIs, that is not the whole

story. There are signs that manufacturers have downplayed known risks

of the lucrative drugs and that regulators and doctors haven't been

skeptical enough about them.

 

Even the theoretical basis for prescribing SSRIs is now in doubt. The

drugs have long been said to work by boosting a brain chemical called

serotonin, correcting a neural imbalance underlying depression and

other ills. That makes them seem the epitome of modern medicine--what

could be safer than restoring a natural balance? A growing body of

studies casts doubt on the theory, however, according to a provocative

report this month in PLoS Medicine, an influential peer-reviewed

journal published by the nonprofit Public Library of Science. The

report points out that scientists have never really understood the

drugs' effects in the brain. Yet pharmaceutical ads still cite the

serotonin theory as a major reason for prescribing SSRIs--a case of

mythmaking " comparable to the masturbatory theory of insanity, " says

British psychiatrist David Healy, a longtime SSRI critic. Drug company

spokesmen counter that considerable scientific literature supports the

serotonin-imbalance idea.

 

A number of scientists have theorized that while boosting serotonin,

SSRIs indirectly inhibit another key neurochemical messenger called

dopamine. That means the drugs may actually create a perilous brain

imbalance in some people. What's more, there's some evidence that

dopamine inhibition underlies several of the rare, serious side

effects linked to SSRIs. One is akathisia, a kind of extreme

restlessness that has been implicated in suicidal impulses--Witczak

believes Zoloft induced akathisia in her husband.

 

The possibility that SSRIs may occasionally induce deranged mental

states conducive to homicide has cropped up again and again in the

news. While evidence supporting that idea is scanty compared with data

on the risk of suicidal ideas and behavior, it isn't easily dismissed

out of hand. Consider some of the testimony at the trial this year of

teenager Christopher Pittman, charged with murdering his grandparents.

Richard Kapit, the ex--FDA official, testified for the defense--he

says he felt compelled to come forward after reading about the case in

the news. Kapit told the jury that the teen was " involuntarily

intoxicated " by SSRIs when he shot his grandparents. Kapit added that

he believes that Pittman, who was being tried as an adult and who was

ultimately found guilty, " didn't have the ability to form criminal

intent " when he committed the murders at age 12.

 

Many psychiatrists feel that stories about SSRIs' side effects should

themselves carry bold cautions against media hype. The risk noted in

the FDA black-box warning last year is limited: Suicidal thoughts and

behaviors occurred in about 4% of youngsters on antidepressants

(mostly SSRIs) in clinical trials, vs. 2% of those taking dummy pills.

That doesn't necessarily mean actual suicides occur more often among

SSRI takers--there's too little data to answer that question. And the

risk must be balanced against the fact that SSRIs help many people--no

one disputes that depression is a huge problem, and even some of

SSRIs' harshest critics concede the drugs can play a valuable role in

treating it when prescribed judiciously.

 

The uproar, in fact, may be hurting some patients without access to

psychotherapy, the main alternative to drugs. Since family doctors are

now often afraid to prescribe SSRIs to kids, more depressed young

people than ever are probably going untreated, says Gregory Simon, a

psychiatrist and health-care policy researcher at Group Health

Cooperative, a Seattle HMO. Prescriptions of antidepressants for

patients 18 and under have plunged by 20% since the suicide issue hit

headlines in early 2004, according to NDCHealth, an Atlanta

health-care information provider. (Less than 5% of antidepressant

prescriptions are written for youngsters.) Says Jerrold Rosenbaum,

psychiatrist-in-chief at Boston's Massachusetts General Hospital:

" Most of us [in psychiatry] think the number of patients harmed by

failure to treat [due to fear of SSRIs] is much higher than the number

who are harmed by treatment. "

 

Of course, many top U.S. psychiatrists, including Dr. Rosenbaum, have

worked with drug companies to establish SSRIs as medicines of choice

for treating depression. Their views aren't universal in

medicine--European authorities have long been more skeptical about the

drugs. Soon after the FDA approved Prozac for marketing in December

1987, German regulators rejected it, partly because of concerns that

the drug increased the risk of suicide; they later approved it but

required Lilly to include a warning in the drug's package insert about

the possible need to prescribe sedatives to counter the risk. Last

December, Britain's National Institute for Clinical Excellence, which

guides that country's health-care policy, recommended that SSRIs and

other antidepressants not be prescribed " for the initial treatment of

mild depression, because the risk-benefit ratio is poor. "

 

And in April the British House of Commons Health Committee issued a

caustic report that may give a preview of things to come in Congress.

SSRIs have been " indiscriminately prescribed on a grand scale, " the

committee concluded, partly due to " data secrecy and uncritical

acceptance of drug company views. " Further, industry promotions have

" worked to persuade too many professionals that they can prescribe

[the drugs] with impunity " to treat " unhappiness [that] is part of the

spectrum of human experience, not a medical condition. " Though

Congress isn't likely to buy into the stiff-upper-lip rationale, it

may put some very awkward questions about SSRIs to their makers and

the FDA in coming months. (Texas Republican Joe Barton and other

Congressmen grilled FDA officials for hours just before the agency put

the black-box warning on SSRIs for kids.)

 

" Ownable syndromes "

 

Drug marketers have been extraordinarily adept at selling SSRIs--even

to people who may not need them. Consider that the drugs, once limited

to treating major depression, are now prescribed for everything from

shyness about peeing in public restrooms to shopoholism. (Such uses

aren't approved by the FDA, but there's no law against doctors

prescribing SSRIs and other drugs for " off label " indications.)

 

The explosive growth of the drugs' market is largely a story of clever

branding as makers of " me too " SSRIs sought to replicate Prozac's

success. Pfizer, for example, positioned Zoloft, launched in 1992, as

a versatile antidepressant that could also treat ills such as

post-traumatic stress disorder. Glaxo targeted Paxil, launched in

1993, at anxiety disorders such as SAD (social anxiety disorder, or

excessive shyness) and GAD (generalized anxiety disorder, or

unremitting angst)--ills that had received little attention before

Glaxo began promoting Paxil to treat them. Lilly countered by

expanding Prozac's indications to include PMDD (premenstrual dysphoric

disorder, or very bad moods some women suffer before their periods)

and depression in children.

 

Indeed, to marketers, SSRIs have been the pharmaceutical equivalent of

Play-Doh. In a remarkably forthright 2003 article, Vince Parry, now a

branding expert at Ventiv Health, a Somerset, N.J., health-care

marketing firm, waxed euphoric about psychiatry's " ownable syndromes. "

Published in a trade journal, the article laid out strategies " for

fostering the creation of a [medical] condition and aligning it with a

product " like an SSRI. Wrote Parry: " No therapeutic category is more

accepting of condition branding than the field of anxiety and

depression, where illness is rarely based on measurable physical

symptoms. " He cites Lilly's positioning of Prozac to treat

premenstrual woe as an excellent example of condition branding--the

company reinvigorated its aging antidepressant by repackaging it in a

lavender pill, dubbed Sarafem, for women with PMDD.

 

But blaming marketers alone for the SSRI fad isn't fair. Doctors,

insurers, regulators--and we eager pill-poppers--are co-conspirators.

Cupertino, Calif., resident Ada Spade, for instance, takes an SSRI for

a condition that even few psychiatrists know about: compulsive

shopping. The problem started about 15 years ago when she was in her

30s, she says. " I'd go to the grocery store and find myself stopping

at eight stores on the way to buy something in every one of them. I

just could not stop. " She tried therapy, budgeting, cash-only

purchasing--nothing had lasting effect. Her life changed a few years

ago when she took part in a study at Stanford University Medical

Center. Funded by Forest Laboratories, it showed that 17 of 24

" compulsive shoppers " given Celexa, an SSRI made by Forest, were

greatly improved--they could even visit malls without buying anything.

" I learned from the study, " she says, " that, yeah, something is a

little wrong with me, but with medication I can be okay. "

 

 

 

FAIR USE NOTICE: This may contain copyrighted (© ) material the use of

which has not always been specifically authorized by the copyright

owner. Such material is made available for educational purposes, to

advance understanding of human rights, democracy, scientific, moral,

ethical, and social justice issues, etc. It is believed that this

constitutes a 'fair use' of any such copyrighted material as provided

for in Title 17 U.S.C. section 107 of the US Copyright Law. This

material is distributed without profit.