From The White House To The Madhouse

[Guest guest]

http://www.prozacspotlight.org/updates/index.html

 

 

 

What do you get when you put American psychiatry, drug companies, the FDA, and

the Bush administration all together in the same room? You get a whole lot of

madness that’s what. At the center of all this madness are Prozac, Zoloft and

Paxil.

 

Living up to the title The Lilly Suicides, Eli Lilly, maker of Prozac, remains

the target of product liability actions asserting that selective serotonin

reuptake inhibitors (SSRIs) can produce agitation, violence, and suicide. In

November of last year Lilly settled another such case, this one involving

plaintiff Diane Cassidy of Monroeville, Pennsylvania. She and her husband Melvin

first attracted attention by picketing Lilly headquarters in 2000, handing out

fliers asking… “Lilly, how many people are maimed or dead on your drug today?”

Such animosity came, the Indianapolis Star (November 30, 2002) reports, after

Diane Cassidy was prescribed Prozac, not for depression, but for the “off-label”

application of weight loss. According to the filed complaint, the drug induced

suicidal thoughts in Ms. Cassidy, which led abruptly to her slashing her wrists

and taking an overdose of painkillers. Today she is paralyzed on one side of her

body and suffers from psychological impairment.

 

As though to take its place, another civil action was filed against Lilly the

same week as the Cassidy settlement, this time in U.S. District Court in

Georgia. The case involved a wrongful death suit filed by plaintiff William

Shell – not to be confused with the case of 60 year-old Donald Schell, who after

being prescribed Paxil two days earlier, shot to death his wife, his daughter,

his infant granddaughter, and then himself. Rather, William Shell is the husband

of the late LaVerne Shell, who, 11 days after starting on Prozac, shot herself

to death at the age of 63. Like Diane Cassidy, Ms. Shell was not taking the drug

for any kind of psychological disturbance, but for an “off-label” use – to treat

migraine headaches. The Shell case also put a new spin on the Prozac-suicide

link, arguing that the longstanding violence associated with the drug occurs

because some small percentage of users are poor metabolizers of the drug -– a

problem Lilly has known about for years and for which

doctors could, but do not, test.

 

As civil actions continue to beat on the door of Eli Lilly – no plaintiff has

yet to win an actual case against them in a court of law – other attacks are

being launched against the SSRI makers by researchers and mental-health

professionals. In good part due to the work of British public health advocate

Charles Medawar, head of the consumer group Social Audit, the British Committee

on Safety of Medicines has put together an expert working group to re-assess the

safety of SSRIs. The conclusions of the group are likely to be influenced by

several new studies, including recent findings from psychiatrist and historian

David Healy.

 

David Healy is perhaps the most knowledgeable person on the subject of SSRIs and

suicide, and his latest report on SSRIs appeared this year in the journal

Psychotherapy and Psychosomatics. The UK psychiatrist has once again found that

SSRIs present an unusual risk of inducing both agitation and suicide when

compared to either placebos or other anti-depressants. This is an effect, the

report states, that is dose related, which means that these risks increase with

dose; it’s also related to the quality of the study in that the more careful the

study, the stronger the link to suicide. This finding is also encountered when

the individual on the drug is a “healthy volunteer.” Similar findings were also

published in the US a few months earlier.

 

As reported in Insight on the News (October 15, 2002), Arif Khan, an adjunct

professor of psychiatry at Duke University School of Medicine, carefully

examined clinical-trail data for the SSRIs gathered from 1985 through 2000,

including the results of over 71,000 participants. Like Healy, Khan found

unusually high rates of suicide and attempted suicides with the SSRIs. He noted

as well that such findings are remarkable because clinical trials actually

exclude those who have a history of suicidal ideation or suicide attempts. While

the general population has a suicide rate of about 11 per 100,000, Khan found a

rate for individuals on SSRIs to be 718 per 100,000. Robert Whitaker, author of

Mad in America, has said about the Khan study that, “You shouldn’t be seeing

four to five times the suicide rate in drug-treatment groups, especially when

these drugs are supposed to prevent this.”

 

Suicide and violence are of course not the only dangerous “side effects”

associated with SSRIs. Just as Eli Lilly and Prozac lie at the center of the

controversy over SSRIs and violence, GlaxoSmithKline (GSK) and Paxil (branded

Seroxat in the UK) lie at the center of a growing storm over SSRIs and physical

dependence. A number of civil actions, including some class-action suits, have

made the case that terminating one’s use of SSRIs can have severe and dangerous

physical and psychological consequences, including nausea, dizziness, sleep

disturbances, and agitation. These consequences can make it very difficult for

an individual to discontinue the drug, thereby creating a physical dependence on

it. Moreover, a 1997 report by the World Health Organization shows how GSK’s

Paxil appears to be especially problematic in this regard.

 

Because of these withdrawal experiences, GSK has also found itself in a bit of

hot water over its promotion of the drug. In October of last year, Britain’s

Guardian (October 12, 2002) reported that GSK had been found by the Prescription

Medicines Code of Practice Authority to be in violation of the industry code of

conduct in their marketing of Paxil. By playing down the dangers of taking the

drug, GSK was found by the UK authority to have failed in three ways: not

limiting themselves to evidence-based claims, misleading the public about the

safety and effectiveness of a drug, and failing to present claims in a balanced

manner. Charles Medawar of Social Audit responded to the decision by stating in

The Guardian that “this is an important ruling which casts doubt on GSK’s claims

that [Paxil/Seroxat] is not addictive.” This ruling follows on the heels of a US

District Court in California, which found Paxil television spots to be

misleading. The ruling was overturned, however, with the

help of the FDA and the US Justice Department, which brings us to the dubious

role of the Bush Administration in all this madness.

 

Here’s where another drug joins our story of SSRI associated suicide: Pfizer’s

Zoloft. The name of the victim: Victor Motus. His story is an especially

interesting one. Late in 1998, Victor Motus was scheduled to fly to Washington,

DC to accept an award from President Clinton. A Filipino-American, Motus was

being recognized for work he had done while serving on a local school board in

Cerritos, California. On the day he was to arrive in Washington – November 12,

1998 – Motus was found in a pool of blood by his wife Flora. Like a number of

users before him, he was dead from a self-inflicted gunshot wound. Motus had

been taking Zoloft for six days. Prior to his death, he had complained to his

wife Flora that the drug made him feel “crazy.”

 

Although Lilly has never lost such a lawsuit, Pfizer was especially concerned

with the Motus suit because it was filed just after GSK lost the Schell SSRI

suicide-murder case in Wyoming. As detailed in an excellent report from the

Boston Globe (December 22, 2002), Pfizer responded to this concern by soliciting

the legal assistance of lawyer Daniel E. Troy. Not merely a lawyer familiar with

the pharmaceutical industry, Troy is also a lawyer who had recently been

appointed chief legal counsel to the FDA by President Bush. Immediately prior to

the appointment, Troy was working as a Pfizer lawyer against the FDA. It can

hardly be viewed as a surprise that, following Pfizer’s solicitation of Troy’s

help on the Motus case, he filed a brief stating that the FDA did not support

the view the SSRIs put some users at greater risk for suicide. When asked about

the Schell case, in which a court determined that indeed there was such a risk,

Troy responded, “I’m not familiar with the case.” Thus,

while Victor Motus was to be honored by President Clinton, his memory was in

the process of being trashed by the reckless pro-corporate administration of

President Bush.

 

The Schell case had involved Paxil and GSK, and while Troy may not have been

interested or informed about it, he was certainly interested in helping GSK with

their current legal problems concerning drug withdrawal. In fact, Troy filed an

FDA brief on their behalf, stating that the FDA sided with GSK in concluding

that Paxil does not produce physical dependence, which makes it habit forming,

but rather produces, like many psychiatric drugs, a “discontinuation syndrome.”

From this position, the FDA also went on to argue that GSK’s ads for Paxil were

not misleading. In fact, Troy was the one who filed a brief against the US

District Judge of California, which led her to lift the temporary order that had

taken GSK’s ad off the air.

 

As the Globe report makes clear, the appointment of someone like Troy can

greatly determine policy even though his appointment does not have to be

approved by Congress. In the case of Troy, one such appointment is having a huge

impact. Another example: after arriving at the FDA, Troy changed the policy

regarding the FDA warning letters that are sent out to drug companies when their

advertising is questionable or false. Now all warnings were to pass through

Troy’s office, with the subsequent effect that, in 2002, the number of warnings

decreased by two-thirds.

 

The Globe report also suggests that Troy’s office is hoping now to ease

regulations restricting a drug company’s promotion of “off-label” use. Before

joining the FDA, Troy and associates sued the FDA over its “off-label” policy,

arguing that drug companies should at least be able to do workshops and send out

articles that supported new (unapproved) uses. Drug makers often favor

“off-label” use because it allows the expanded use of a drug without the company

having to test whether that use is safe or effective; since all this is

happening without the company’s official recommendation, they are generally

viewed as not responsible for a drug’s effectiveness. The deregulation of this

off-label use by Troy would mean the almost immediate return to the days of 19th

century patent medicines when “drug companies” could advertise anything,

regardless of the validity of its merits, and with little or no liability. As

the Cassidy and Shell civil actions make all too clear, where each case the

use was “off-label,” such an idea is – like the drug companies themselves –

reckless and dangerous.

 

-Richard DeGrandpre

 

 

 

Recent Developments from a Mad World

August 26, 2002

 

 

 

 

 

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