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| Prozac Hangover |
Current rating: 0 |
by Rick Giombetti
Email: rickjgio
(nospam) speakeasy.org
(unverified!)
Address: PO Box 2464, Seattle, WA.
98111 |
26 Aug 2001 |
| The author provides the reader
with a Seattle mother's story of her son's 1990 suicide while
on Prozac, a corrective of the media myth that Prozac produces
few side effects at the passing the Eli Lilly & Co.'s
patent for the drug, a brief history of Prozac and, finally,
the author analyzes a recently published article by Dr. David
Dunner of the Department of Psychiatry at the University of
Washington. |
Prozac: A Mother's Story
"There's no such thing as a safe and effective
drug," said Coralie Reid of Seattle while reflecting on the
1990 suicide of her son Chris, who had been on Prozac for five
weeks when he took his own life. "Alcoholics can't function
without alcohol. Nobody thinks this is a good thing. Now why
do so many people think it's a good thing that millions of
people in this country can't live without their Prozac?"
Reid isn't counting herself among the media led
applause for Prozac at the passing of Eli Lilly & Co.'s
patent on its top selling antidepressant drug, which happened
at the beginning of August (Lilly has been granted exclusive
marketing rights over a repackaged version of Prozac called
Sarafem for the next several years. Sarafem is prescribed for
a variant of PMS known as "Premenstrual Dysphoric Disorder,"
or PMDD). Reid can be counted among the growing number of
people who boo at Eli Lilly's contention that Prozac and its
clones, like GlaxoSmithKline's Paxil or Pfizer's Zoloft, are
essentially safe and effective drugs that produce few side
effects.
Reid's 18-year-old son started taking Prozac
after it was prescribed to him by a psychiatrist in February
1990. Chris made his appointment with a psychiatrist while
seeking psychotherapy. He wasn't severely depressed, much less
suicidal, and the last thing he thought he would need was a
prescription for a psychiatric drug. What he got instead was a
20 minute consultation, a psychiatric diagnosis and a
prescription for Prozac, the latest wonder drug for depression
at the time. Chris's experience with the mental health system
has become the rule over the past three decades, as the modern
mental health system has steadily changed its focus on
psychotherapy to a focus on psychiatric diagnosis and the
prescribing of drugs like Prozac. The only other contact Chris
would have with his psychiatrist would be for the purpose of
refilling his Prozac prescription. It was after Chris began
using Prozac that his family and friends began noticing his
strange, out-of-character behavior.
"Before he died,
he fell asleep with his feet on a radiator," said Reid. "He
melted the soles of his shoes and he never woke up while it
was happening. Chris had no consciousness about what he was
doing when he was on Prozac. Anything he did seemed like it
was all right to him." Everything about Chris changed after he
began taking Prozac, says Reid. He became severely agitated
when he took his daily 20 mg. dose of the drug in the morning.
On a few occasions he would come down from his P ozac-induced
agitation and fall asleep in the early afternoon. He became a
heavy coffee drinker while on Prozac. He cried more than he
ever had before while on Prozac. He backed a car into a window
on the family home. He suffered a tremendous weight loss while
taking Prozac. His mother noticed that Chris's arms were
nothing but skin and bone as she walked down the aisle
arm-in-arm with him at his sister's wedding. The most
disturbing change happened when Chris became verbally and
physically abusive towards his girlfriend, something that had
never occurred before he began taking Prozac.
The next
occasion for a family gathering after her daughter's wedding
would not be a happy one for Coralie Reid. It would be for her
son's funeral. Chris Reid died after he started an automobile
in an enclosed garage on March 11, 1990. He never told anybody
he was suicidal. He left no suicide note. He had never been
suicidal or violent before taking Prozac. Chris's shocking
behavior and his suicide left a mother wondering why it all
happened. Coralie Reid could not get any answers from anybody
about Prozac and its side effects during her son's short time
on the drug. It would take years before she would begin to
understand what had happened to her son while he was on
Prozac.
Lilly's Prozac Patent Passes: Let The
History Rewriting Begin
Barr Laboratories had just
begun shipping it's generic version of Prozac, Fluoxetine
Hydrochloride, to market in August of this year and the
rewriting of the actual history of Lilly's side effect prone
drug was already on. Barr won the right to ship its generic
version of Prozac to market three years early and the event
was met with a flurry of media attention reflecting on
Prozac's effect on the history of psychiatry and mental health
treatment. "It (Prozac) became a blockbuster (selling drug)
because it lacks the harsh side effects of earlier depression
medicines," wrote Theresa Agovino in an August 3 Associated
Press article about Barr's first shipment of its generic
Prozac. "Prozac's success was partly due to the drug's reduced
side effects compared to earlier antidepressants," Shankar
Vedantam wrote in an August 5 Washington Post article
reflecting on Prozac's legacy. Examples of this kind of
rewriting of the history of Prozac can be found at the local
level across the nation as well. Writer Mary Feingold repeats
the same line about the safety and effectiveness of Prozac and
its clones while pondering why anti-depressant drug use is so
high in such a great place to live like Madison, Wisconsin in
the August issue of Madison Magazine.
The actual
record of Prozac speaks to a much different reality than the
assertions of efficacy and safety being made in most of the
media. In fact, Prozac has logged more reports of Adverse Drug
Reports (ADR's) with the Food and Drug Administration (FDA)
than every other prescription drug combined. As of June 18,
1992, Prozac had been associated with 23,067 ADR's, including
1313 deaths. The total number of ADR's for all other drugs
combined at the time was 15,274, including 861 deaths. As of
October 1993, Prozac had logged 28,623 ADR's only into its
sixth year on the market. At the same time Elavil, an older
anti-depressant that had been on the market for 20 years, had
received only 2,000 complaints of adverse reactions. Valium,
the most popular psychiatric drug before Prozac, had only
received 7,000 complaints at the time after 22 years on the
market. After only several years on the market Prozac had
creamed the field in producing ADR reports. This year the
total number of ADR's for Prozac is now at about 44,000,
including about 2,500 deaths (Prozac: Panacea or Pandora?,
2001 edition).
It's worth noting that ADR's are only
made to the FDA on a voluntary basis. This makes these figures
even more amazing given that Lilly has never stopped asserting
that its top selling drug is basically safe since its approval
for commercial use in December 1987. It also means that the
public has anything but a complete picture of how many adverse
side effects this drug has really produced in the tens of
millions of people who have taken it, as all too often adverse
reactions to the Prozac class of drugs are wrongly attributed
to the worsening of a patient's psychiatric symptoms.
Contrary to all the assurances of expert defenders of
Prozac and its clones that there is nothing to worry about
these drugs is the September 1997 FDA recall of the popular
diet drug Redux, or Phen-fen. Redux was pulled from the market
because of its link to valvular heart disease in individuals
using the drug. Perhaps the above quoted writers don't know
this but Redux is designed to do the same thing Prozac does to
the brains of its user. Namely, Redux revs up the presence of
the neurotransmitter serotonin in the brain. Most disturbing
of all is a study investigating the brain damage done to
monkeys given Redux published in the August 27, 1997 Journal
of the American Medical Association. The group of researchers
lead by Dr. Una McCann at the National Institute of Mental
Health argued that brain damage in Redux may only become
"manifest with advancing age."
Redux is an extremely
toxic combination of two drugs known as phentermine and
fenfluramine, hence its shortened nickname "Phen-fen." Redux
had been used for years as a treatment for obesity in Europe
and its potential dangers had been identified by researchers
long before it had won FDA approval as a diet drug in 1996.
Peter Breggin of the Center for the Study of Psychiatry and
Psychology in Bethesda, Maryland wrote in his his new book The
Anti-Depressant Fact Book that "for several decades evidence
had been accumulating that fenfluramines, including
dexfenfluramine (Redux), destroy brain cells and chronically
impair mental function. They are amongst the most neurotoxic
drugs ever approved for use in the United States, but the
medical and psychiatric profession showed shockingly little
concern about permanently damaging the brains of their
patients."
There are also plenty of breaking
developments on this issue that are there for the taking but
it's hard to find much interest in them in the Seattle Times
or the Seattle P-I. The most important development on this
front has to be the recent jury verdict in a civil trial
against British pharmaceutical giant GlaxoSmithKline (GSK),
manufacturer of the potent Prozac clone known commercially as
Paxil (Its known as Seroxat in the United Kingdom) and the
world's largest drug company. A jury in a federal district
court in Cheyenne, Wyoming ordered GSK to pay the family of
Donald Shell $6.4 million for his murderous rampage while on
Paxil on February 13, 1998 in Gillette, Wyoming. Schell took
two Paxil tablets before shooting his wife, his daughter and
his 9-month-old grand-daughter to death. Schell then took his
.22 calibre pistol to himself and committed suicide. Company
documents revealed that GSK was aware that Paxil could cause
healthy volunteers to become suicidal during clinical testing
for the drug. The jury found Paxil to be 80 percent
responsible for Schell's murderous actions towards his family
and himself (abcnews.go.com, June 6, 2001). GSK argued that
Schell would have committed suicide without taking Paxil and
that its drug would have prevented the suicide if it had time
to take effect. The company is appealing the verdict in
federal court in Denver.
Furthermore, and most
importantly, GSK admitted to the the Medicines Control Agency,
the British version of the FDA, that patients who begin drugs
like Prozac or Paxil may be at an increased risk of suicide in
July of this year. GSK agreed with the MCA's request to issue
a warning to doctors and patients about potential suicidality
linked to Paxil. In fact, the MCA has been requesting the same
suicide warning for all of the Prozac class of drugs,
including Prozac, Zoloft, Luvox, et al., for over a year
now("Suicide Fear Over Anti-Depressant," by Sarah Boseley,
Guardian Unlimited, July 10, 2001). What is most interesting
about the GSK cave-in to the demands of the MCA is that it was
brought about by the verdict of a jury in a U.S. courtcase,
yet the media in this country has shown little interest in
covering this story.
None of these amazing
developments have been reported in the Times or P-I. The Times
did run an article about the marketing of Paxil by Shanker
Vendatam of the Washington Post on July 17. Yet no article
about the verdict in the Paxil trial or GSK's new warning
about Paxil's potential link to suicide was ever published.
Neither the Denver Post nor the Rocky Mountain News, the two
closest large circulation dailies from where the Paxil trial
took place, ever published any articles about the trial
either. Searches of the websites of the New York Times, the
Washington Post and the L.A. Times turns up only a couple of
articles about these developments in the NY Times. The NY
Times reported the jury verdict in the Paxil trial on June 8
and the judge's refusal of GSK's request for a retrial on
August 11. Neither of these three major newspapers reported
GSK's compliance with th MCA's request to include a suicide
warning with its drug Paxil.
The plaintiff's expert
witness in the Paxil trial in Wyoming was Dr. David Healy, one
of the United Kingdom's foremost researchers in
anti-depressant drugs and author of The Anti-depressant Era.
Guardian health editor Sarah Boseley reported on May 7 that
Healy calculates that at least 250,000 people worldwide have
attempted suicide because of Prozac, and 25,000 of them have
succeeded. Healy conducted the first study ever to demonstrate
that Prozac can induce suicidal thoughts in healthy
volunteers. Healy argues that between 1 in 20 and 1 in 10
people who take Prozac can develop akathisia, or extreme,
restless agitation, and become suicidal (Primary Care
Psychiatry 2000; 6:23-28). Prozac manufacturer Eli Lilly
adamantly denies any link between Prozac and suicide.
Healy's high reputation within academia
internationally has been a cause of worry for Lilly and the
last thing the Indianapolis-based pharmaceutical giant would
want is for the British psychiatrist to make his home on this
side of the Atlantic. Even though Prozac's patent has run out,
the drug still stand's to be a steady revenue stream even at
the reduced generic price. Prozac sales were $2.6 billion for
Lilly in 2000 so even at the 25-40 percent reduced price the
drug could still generate over $1 billion per year in sales
for the foreseeable future. The only thing that could put an
end to Prozac's money making potential for Lilly would be a
suicide warning label easily accessible to doctors and
patients here in the U.S., like the suicide warning British
regulators have forced GSK to put on Paxil.
Boseley
continues with her story about Healy in the May 7 Guardian by
describing a prestigious Canadian university's abrupt rebuff
of a job offering they had made to Healy. The University of
Toronto began courting the respected Dr. Healy for a job at
its Centre for Addiction and Mental Health (CAMH) in 1999. By
January of 2000 Healy had accepted the job offer and the only
obstacle to his moving to Toronto was the red tape involved
with emigrating to Canada. Then Healy gave a talk at a two day
conference at the CAMH later in the year on November 30. In
his talk Healy didn't shy away from claiming that Prozac can
cause suicide. Eight days after Healy gave the talk he was
told by David Goldbloom, physician-in-chief at the CAMH, that
they weren't going to be hiring him for his new job after all.
Healy and his defenders believe that the reason why he wasn't
hired was because of the behind-the-scenes pressure being
applied by Lilly. Lilly is a major funder of the CAMH and
Healy believes that was the decisive factor in what prevented
him from getting the job he was offered. Lilly denies having
anything to do with the decision.
Whether or not Lilly
cost Healy his job in Toronto, there can be little doubt that
the company will fight long and hard to prevent the term
"suicide" from being exported from Britain to North American
shores. Perhaps no drug company has gone to greater le gths
than Lilly has to market and defend a drug, as in the case of
Prozac. Lilly has weathered every media inspired controversy
surrounding the drug and every lawsuit against the drug quite
well. The drug's reputation as a therapeutic agent for
depression has remained intact despite being the record holder
for adverse side effects reported to the FDA and the mounting
evidence linking it to violence and suicide in its users.
Perhaps no greater disservice has been done to public
health during Prozac's 13 year reign as the top selling
antidepressant drug than the lack of information for doctors,
patients and family members about what this drug does and the
side effects it produces. Observing the marketing of Prozac
and public discourse about the drug, one is left with the
impression that what is being talked about is not a drug, but
rather a feel-good-in-the-morning bon-bon. Prozac is almost
seen as candy, but it's not. This is a powerful drug that
disrupts the body's entire biochemistry and it produces
multiple side-effects. Yet it's not marketed as such by Lilly.
Perhaps no prescription drug in history has been
marketed with so many claims of safety and therapeutical
benefits and so little evidence to back it up. As we will
observe in the next section, not even 300 people finished the
clinical trials that won FDA approval for Prozac and the
average trial lasted about 4-8 weeks. Although these drugs
were originally tested and marketed as anti-depressants, in
over a decade on the market the additional conditions Prozac
and its clones are prescribed for include anxiety, obsessions,
compulsions, eating disorders, headaches, back pain,
impulsivity, drug and alcohol abuse, hair pulling, nail
biting, upset stomach, irritability, sexual addictions,
premature ejaculation, attention deficit disorder and
premenstrual syndrome. A majority of these drugs are now
prescribed by primary care physicians with little or no
knowledge of their potential long term side effects or their
potential for causing addiction. This is why Coralie Reid
could find almost no information about what Prozac was doing
to her son before he committed suicide. To understand how this
happened it is necessary to know the story behind Prozac, its
manufacturer Eli Lilly and the nonexistence of an effective
regulatory apparatus that could have warned Reid and countless
millions of others about the dangers of Prozac.
The Prozac Story: A Drug Company With A Dark Past
Pulls Off A Marketing Bonanza With Prozac
As far
as example of previous prescription drugs are concerned,
Prozac and its clones are most similar to LSD. Most of the
public associates this drug with the '60s drug
counter-culture. There was acid guru and former-Harvard
professor Timothy Leary, who longed for nothing more than a
day when everybody would take this drug. There was also Ken
Kesey's Merry Prankster's and their famous "acid tests"
immortalized in Tom Wolfe's The Electric Kool-Aid Acid Test.
What most people don't know is that LSD was p tented by Prozac
manufacturer Eli Lilly in 1956 and, of course, the company
marketed is as a wonder drug, much like it would do with
Prozac over 30 years later. The drug was created by Swiss
pharmaceutical Sandoz in 1943. Lilly was awarded the U.S.
patent for the drug mainly for supplying the CIA with it for
its own "research" purposes. LSD didn't sell well and would go
on to be most remembered for its illegal use within the
counter-culture.
The other famous hallucinogenic drug
of the '60s and '70s drug culture that is similar to Prozac
was PCP, or "angel dust." The drug was developed and patented
by Parke, Davis and Co. in 1957 as a pain killer and
anesthetic. Although the actual experience with PCP proved to
the contrary, the drug was marketed by Parke, Davis as having
a large margin of safety. By 1967, Parke, Davis pulled the
drug from the market. It wasn't until 1978 that the drug was
classed as a schedule three drug (having no therapeutic use).
The drug became notorious for producing violent manic
reactions in users during its heyday as a street drug of abuse
in the '70s. Police officers feared seizing it because
intoxication could be induced by way of mere skin contact.
"There's nothing new about these drugs (Prozac and its
clones)," says Dr. Ann Blake Tracy of the Coalition For Drug
Awareness in West Jordan, Utah. "These kinds of drugs have
been around for decades. The only difference with Prozac and
its clones is that each new drug being marketed is stronger
than the preceding drug." Utah is the depression capital of
the United States. The state has the highest per capita usage
of Prozac and other antidepressant drugs in the nation so
Tracy considers herself well placed to document the side
effects of Prozac and its clones ("Washington State No. 4 In
Anti-depressant Use," Seattle Times, June 21, 2001). Tracy
argues in her seminal book on research into Prozac, Prozac:
Panacea or Pandora?, that every drug termed an
"anti-depressant" by the pharmaceutical industry and
psychiatry basically boosts levels of the important
neurotransmitter serotonin, much like LSD and PCP.
The
theory behind Prozac and other anti-depressant drugs is that
low levels of serotonin is what causes depression in people.
Serotonin is an important neurotransmitter found in the brain
and throughout the body. This chemical fires synapses in the
brain and regulates the movement of muscles in the intestinal
tract and throughout the body. Lilly and other drug companies
argue that revving up the amount of Serotonin in the brain has
therapeutic benefits for people experiencing depression and
other mental disorders. The pharmaceutical industry's main
selling point with anti-depressant drugs is that they
"selectively" rev up the amount of serotonin in the brain and
nowhere else in the body. By selectively disrupting the
metabolism, or "reuptake," of serotonin in the brain, Prozac
and its clones are claimed by the pharmaceutical industry and
psychiatry to only affect a particular neurotransmitter in a
particu ar part of the body, and nowhere else in the body.
Hence, the term "Selective Serotonin Reuptake Inhibitors," or
SSRI's, is the name Prozac and its clones have been given by
the pharmaceutical industry.
There are limitations to
Prozac in theory and practice that the health care profession
and the media don't seem to want to deal with. Serotonin is an
important neurotransmitter but it's only one of more than 100
that have been discovered so far (Glenmullen, Prozac
Backlash). Little is known about how serotonin and the rest of
the body's neurotransmitters work. So isn't trying to rev up
the amount of serotonin in a particular part of the body like
putting your eggs in one basket? How would doing this affect
the more than 100 other neurotransmitters throughout the body?
Would the body compensate for the increase in serotonin by
decreasing the amount of the other neurotransmitters, like
dopamine, which regulates the movement of involuntary muscles?
Can this claim of "selective" action on serotonin in the brain
by the SSRI drugs really be taken seriously? About 90 percent
of serotonin is found in the intestinal tract so wouldn't
SSRI's increase the amount of the chemical in that part of the
body as well?
"I can't believe the drug companies have
gotten away with telling the public that low levels of
serotonin are what causes depression," says Tracy. "We've
known for decades that high levels of serotonin can cause
depression and lead to violence in people and animals." Tracy
cites the research of Felix Sulman in Israel in the '50s.
Sulman found that increased serotonin levels could cause
violence in rabbits, which rank among most docile of all
creatures. If serotonin levels become high enough, they can
lead to what is known as Serotonin Syndrome, which can cause
organ failure and possible death. Further research has linked
increased serotonin levels with an agitated sleeplessness that
can lead to mania and suicide. This is why the CIA was
interested in researching the affects of LSD on people. The
agency wanted to see if individuals on the drug be put into a
drug-induced insanity, and this turned out to be the case in
many of the subjects tested on the drug. This is why Tracy
argues that the claim that low levels of serotonin leads to
depression is turning the research into serotonin upside down.
The period of the clinical trials leading up the FDA
approval for Prozac was a dark time for Lilly. The company was
reeling from the marketing debacle of its Oraflex drug, which
was recalled by the FDA in August 1982 after only three months
on the market. Oraflex was prescribed as an anti-imflammatory
agent to treat aches and pains due to conditions like
arthritis. The marketing campaign for Oraflex got off to a
fast start, reminiscent of the company's campaign for Prozac
several years later. Prescriptions for Oraflex quickly reached
55,000 per week. However, Oraflex would eventually be linked
to the deaths of over one hundred patients in the U.S. and
Britain. Lilly, including its chief medical officer, Dr.
W lliam Shedden, were cited by the federal government with 25
counts related to mislabeling side effects. Lilly pleaded
guilty to the charges in 1985 and the
multi-billion-dollar-per-year company was handed a $25,000
fine. Dr. Shedden pleaded "no contest" to the charges, was not
sentenced to any jail time and found a job at another
pharmaceutical company after leaving Lilly.
Although
the federal government only handed Lilly a wrist slap for a
fine, the admission of guilt in federal court led to
approximately 1,500 lawsuits being filed against Lilly,
possibly costing the company billions of dollars. In one
Oraflex case Lilly paid out $6 million to the son of an
81-year-old woman who died while taking the drug. Lilly had to
market a new wonder drug or possibly face the music in
bankruptcy court. It was in this atmosphere that Dr. Leigh
Thompson would succeed Dr. Shedden as the company's chief
medical officer. It was Thompson who would go to the mat to
defend Prozac and prevent the drug from suffering the same
fate as Oraflex did. There was almost nothing Lilly wouldn't
do to prevent Prozac from being associated with adverse
reactions and death. It was in this atmosphere that the
clinical trials were being conducted by Lilly paid scientists.
An interesting fact about the FDA, the regulatory
agency that oversees the pharmaceutical industry, many people
are probably not aware of is that the agency does not test
drugs it approves for medicinal use. All of the clinical
trials that lead to the approval of drugs for commercial use
in the U.S. are funded and directed by the companies who
market and manufacture the drugs. This should be kept in mind
when drug company officials and their paid scientists calmly
assure the public that rigorous, long term testing into the
safety and efficacy of prescription medications are done
before they are brought to market. This is absolutely untrue.
Given that private drug companies rely on marketing drugs they
have exclusive patents for, it shouldn't be surprising that
these companies do anything but long term drug testing in the
trials they fund or that they do everything they can to
conduct trials which favor the new drug. The trials that lead
to the FDA approval for Prozac were no different in this
regard.
One of the methods Lilly used in the clinical
trials for Prozac was what is known as the "placebo washout."
The placebo washout is when researchers deliberately exclude
subjects who respond well to a placebo, or sugar pill, from a
clinical trial. All drugs being tested for FDA approval must
be tested in studies that use the new drug, an older variant
of the new drug and a placebo. These are what are known as
double-blind studies, whereby the subjects and the doctors
administering the drugs and placebo don't know what is being
taking. Critics argue that the purpose of the placebo washout
is to rig the trial in favor of the new drug by showing it can
work better than a placebo. The point of the placebo washout
out is to show a statistically significant difference in
subject response in favor of the new drug over a placebo. This
can only be achieved by lowering the number of subjects a
researcher believes might respond well to a placebo before the
trial happens. Yet more than one of the trials found Prozac to
work only a little or no better than a placebo. Prozac did not
do any better when compared to older anti-depressants as well.
Breggin notes in The Anti-Depressant Fact Book that every
anti-depressant approved by the FDA used the placebo washout
in clinical trials (The author got into an argument with a
pre-med student about the pros and cons of the placebo washout
while writing this story. The pre-med student argued that the
placebo washout actually creates a higher standard for the new
drug because people who respond well to placebo would respond
well to anything, including the new drug. One of the lead
investigators for Lilly during the Prozac trials was Dr. David
Dunner of the University of Washington. Perhaps Dunner would
make a similar argument in defense of the placebo washout but
he refused to be interviewed for this article.).
Lilly
knew from the beginning that Prozac could cause adverse side
effects in people taking the drug. Company documents revealed
in the hundreds of lawsuits that have been filed against
Prozac show that the company was aware of the possibility of
the drug causing Parkinson's-like shaking and severe agitation
in the first human subjects who took the drug in the late
'70s. One case of severe agitation was so bad the subject had
to be taken off the drug. The company began permitting the use
of benzodiapine tranquilizers on patients to calm them down
while taking the drug. One of the ways Lilly masked these
adverse reactions of Prozac in the clinical trials during the
'80s was by explicitly excluding any investigation into links
between the drug and suicide. The company masked any suicidal
reactions to the drug by labeling them with the term
"depression."
Critics argue that the most egregious
example of rigging during the Prozac trials was the use of
tranquilizers by researchers in order to mask the new drug's
stimulant profile. The use of other drugs in clinical trials
is strictly forbidden for the obvious reason that it makes it
impossible to conclude which drug is responsible for which
adverse side effect. Yet Lilly did this throughout the Prozac
trials and the FDA allowed the company to get away with it,
demonstrating once again its inability to act as an impartial
regulatory agency of the federal government. In Talking Back
To Prozac, Peter Breggin demonstrated how Lilly hid Prozac's
stimulant profile by using tranquilizers in combination with
the drug on Prozac trial subjects and by creating an
unreadable label for the drug.
The FDA would approve
Prozac for commercial use as an "anti-depressant" medication
in December 1987 despite its obvious stimulant profile,
overriding the concerns of its chief medical officer in charge
of evaluating Prozac, Richard Kapit. Kapit was concerned the
drug could cause "a set of adverse effe ts which resemble
those caused by amphetamine," and that "fluoxetine (Prozac)
may negatively affect patients with depression." Lilly would
begin marketing Prozac as a drug that was found to be safe and
effective after rigorous, long-term testing on thousands of
subjects. Breggin discovered when he became an expert witness
in some of the hundreds of lawsuits filed against the company
for its marketing of Prozac that only a total of 286 subjects
ever finished the trials used for the drug's approval. The
average length of the trials was only about 4-8 weeks. Lilly
has never challenged Breggin in court on these numbers. Like
with every other drug approved by the FDA, Prozac was brought
to market with basically no long term testing on enough
subjects to determine its long term side effects. This left an
uninformed public as de facto guinea pigs for determining the
long term side effects of Prozac. The drug would quickly
become the all-time leader in logging reports of adverse
reactions to the FDA.
The early marketing of Prozac
went much like the marketing of Oraflex. Lilly touted its
latest wonder drug as a break through in the science of
treating depression. Prozac was the first drug to ever
selectively increase the amount of serotonin in the brain,
Lilly's early advertisements for Prozac stated. The actual
experience of patients on Prozac has proven to be quite
different from the claims made by Lilly in its marketing of
the drug, as patients have consistently reported the drug
having affects throughout the body. Prozac quickly became the
top selling anti-depressant drug in the world.
The
first five bell alarm Lilly had to contend with happened early
in the Prozac era. On September 14, 1989 Joseph Wesbecker, an
employee who had been on leave from his job at the Standard
Gravure printing plant in Louisville, Kentucky for
stress-related reasons, walked into his former place of
employment armed with an AK-47. Wesbecker took an elevator to
the third floor of the plant and in robot-like fashion began
opening fire on his former colleagues. Eight people would be
killed and twelve injured before Wesbecker took his own life.
Wesbecker was on Prozac when he went on his murderous rampage.
It was a murderous attack remarkably similar to the Littleton,
Colorado high school shooting ten years later for its
remorseless savagery (One of the killers in Littleton, Eric
Harris, was taking the Prozac clone known as Luvox at the
time. Breggin confirms this fact in The Anti-Depressant Fact
Book. What psychiatric drug Harris's partner-in-crime Dylan
Klebold was on at the time of the shooting has not been
discovered.).
Although the sales of Prozac were sky
rocketing early in its marketing, the number of adverse
reactions to the drug being reported were sky rocketing as
well. The drug's dangerous side effects began getting national
media attention by the beginning of the '90s. Most distressing
of all for Lilly was a seminal study about Prozac's potential
links to suicidality by a team of researchers lead by
Harvard's Martin Teicher. The results of the study were
published in the February 1990 issue of the American Journal
of Psychiatry. Teicher and his fellow researchers Jonathan
Cole and Carol Glod found that Prozac could induce "intense,
violent suicidal preoccupation." With the reports of adverse
reactions to Prozac coming in from across the nation, the FDA
decided to convene a "blue ribbon panel of experts" to
investigate the safety of Prozac in 1991.
The day-long
FDA hearing on Prozac's safety on September 20, 1991 was
rigged from the start to favor Lilly and Prozac. These "blue
ribbon" panels of experts are supposed to be comprised of
individual experts with no conflicts of interest. However, the
FDA allowed five of the nine panel members, including Dr.
David Dunner of Department of Psychiatry at the University of
Washington, to sit on the panel despite their links to the
drug industry. Dunner had been a lead investigator into one of
the four trials Lilly submitted to the FDA for approval of
Prozac (for more on Dr. Dunner see the section below). Also,
four of the panel's six consultants had links to the drug
industry. The FDA waived its own standards regarding conflict
of interest by granting these nine individuals "waivers" in
order to participate in the hearing. The FDA used the specious
reasoning that the panel being convened that day would not
specifically discuss Prozac. This was ridiculous given that
concerns about Prozac's safety were the reason for the hearing
in the first place.
Fifty members of the public
addressed the panel for up to five minutes each. Many of these
people told dramatic stories of becoming suicidal while on
Prozac. Others told the panel of stories of family members who
had committed suicide while on Prozac. Among those attending
the hearing was Coralie Reid of Seattle. She never did testify
before the panel about her son's suicide or even present the
panel with any written testimony. She met Ann Tracy for the
first time at the hearing and would go on to assist her
research for Prozac: Panacea or Pandora? Reid would help Tracy
obtain the official records of Dr. Dunner's fundraising from
drug companies for his department at the University of
Washington. Tracy points out in her book that at the time of
the Prozac hearing Dunner had received over $1.3 million in
research grants from Lilly since 1982.
Meanwhile, the
hearing continued after the public testimony phase. Four Lilly
scientists were given a generous amount of time to present the
company's case before the panel. Teicher was also asked to
speak before the panel about his seminal study into Prozac and
suicidality but was completely stifled when he attempted to
present his findings. In a decision nobody could have
predicted, the panel unanimously gave Prozac a clean bill of
health in the area of safety. However, the panel was divided
on the issue of whether or not to give Prozac a stricter label
warning of its potentially violent side effects. The panel
voted 6-3 against requiring a stricter label for Prozac. Dr.
Dunner voted against including a stricter warning label for
the drug.
Lilly would use the rigged outcome of the
Prozac hearing to trumpet Prozac's safety to doctors and in
the media. Lilly had weathered the first Prozac scare quite
well. The drug was at least immune from being recalled the
same way Oraflex had been nine years earlier. The only other
public relations threat to Prozac the company now needed to
fight off was the bad press and high costs that come with
hundreds, potentially thousands, of lawsuits, like the 1,500
lawsuits over Oraflex that put the company on the verge of
bankruptcy. In order to fight off the trial lawyers Lilly
would engage in what might be the most egregious example of
the rigging of a court trial in U.S. history. Twenty-seven
survivors and family members of the deceased in Joseph
Wesbecker's murderous rampage while on Prozac filed suit
against Lilly. The case came to trial in the fall of 1994.
While the nation's attention was riveted to the ongoing
developments in the O.J. Simpson trial, Lilly would quietly
score a courtroom victory that basically put an end to most of
the more than 150 pending lawsuits against the company over
Prozac at the time.
When the case came to trial Lilly
had to desperately fight off attempts by the plaintiff's
attorneys to introduce the Oraflex debacle as evidence before
the jury. Lilly's lawyers furiously fought against the
introduction of any mention of Oraflex in the trial in the
private chambers of the judge in the case, John Potter. Judge
Potter initially ruled in Lilly's favor on this matter but
when Lilly officials testified about how wonderful the company
was and how the company would never market a dangerous product
to the public, he changed his mind.
The details of
what exactly happened after Potter gave the plaintiff's
attorneys the go ahead to introducing the Oraflex debacle as
evidence in the trial are not completely known even to this
day. What is known is that Lilly secretly entered into
negotiations for settlement with the plaintiff's attorney's in
the case while the trial continued. What Lilly did was promise
to pay a higher amount of money in the settlement to the
plaintiff's, if they went through with the trial and Lilly won
in the trial verdict. The only way the plaintiff's lawyers
could throw the case in Lilly's favor would be to not include
any mention of the Oraflex debacle to the jury. After the
plaintiff's attorney's told Judge Potter that they weren't
going to introduce any of the Oraflex evidence they had fought
so hard to include only a day after his ruling on the matter,
he asked all parties in the case on more than one occasion if
settlement had been reached. On each occasion the parties lied
by denying having reached a settlement. The nerves of Lilly's
officials would have to hold out for the verdict in the trial
and they would eventually get their wish. The jury voted 9-3
in favor of Lilly, deciding that Prozac was not the primary
cause of Joseph Wesbecker's murderous rampage. It was the
narrowest mar in allowable in a civil trial. One more vote
against Lilly would have ended the trial in a hung jury.
Lilly quickly played up the verdict as a vindication
for Prozac and the story of the Wesbecker verdict instantly
became headline news. What didn't receive the same amount of
media attention was Judge Potter's later ruling overturning
the court room verdict and changing it to a settlement. Potter
was upset with the appearance of his courtroom being used for
Lilly's own PR purposes. He would have to take his case all
the way the Kentucky Supreme Court in order to conduct a
hearing into whether or not a settlement had been reached
behind his back during the trial. Potter eventually overturned
the trial verdict and the Kentucky Attorney General would
later rule in his favor after conducting an investigation into
the case. Nicholas Varchaver wrote about Lilly's rigging of
the Wesbecker trial in a 1995 American Lawyer article titled,
"Lilly's Phantom Verdict." British Journalist John Cromwell's
reporting of the Wesbecker trial is summarized in his 1996
book Power to Harm: Mind, Medicine, and Murder on Trial.
The headline media coverage of the verdict in the
Wesbecker trial and the almost complete lack of coverage of
the overturning of the verdict helped Lilly decisively
vindicate Prozac in the public eye. Most of the 150-plus
pending lawsuits against Lilly over Prozac at the time were
quickly dismissed or quietly settled out of court. There would
be no tidal wave of thousands of Prozac lawsuits. Lilly would
hold onto to its Prozac patent with the drug's reputation
intact for another seven years.
The final major PR
exercise Lilly conducted in defense of Prozac was when the
company sponsored a closed symposium on what the company
termed "SSRI Discontinuation Events," held December 17, 1996
in Phoenix, AZ. The results of the symposium were published as
Supplement 7 in the 1997 Journal of Clinical Psychiatry.
Instead of dealing head on with one of Prozac's adverse side
effects, one of the reports put together by the group of Lilly
sponsored scientists advocated using the euphemism
"antidepressant discontinuation syndrome" rather than
"withdrawal" because: "Unfortunately, the public often
perceives wrongly that antidepressants - like alcohol and
barbiturates - are addicting." The term "discontinuation"
instead of withdrawal is used throughout the 40-page
supplement making it a case study in industry double-speak.
However, the supplement does contain a frank discussion by
Jerrold Rosenbaum and John Zajecka starting on page 37 about
how doctors should go about "discontinuation," or withdrawal,
with patients experiencing adverse withdrawal reactions,
including how to go about a gradual tapering off of SSRI's.
The closed symposium and the published findings of the
symposium basically amounted to an admission by Lilly that
SSRI's can and do cause addiction in it users.
On the
topic of withdrawal Dr. Tracy has always been an advocate of a
slow, tapered withdrawal from all SSRI's. She would disagree
with Rosenbaum and Zajecka's assertion that there is no need
to go through with a tapered withdrawal from Prozac because it
has the shortest half-life of all the SSRI's. She wouldn't
agree with the rates of taper they suggest either, usually
ranging from 25 to 50 percent reductions over a 5-7 day
period. Every SSRI introduced since Prozac, first with Zoloft,
then followed by Paxil, Luvox, Celexa and others, is stronger
and more fast acting. Hence, the shorter half-lives of the
stay of the newer SSRI's in the bodies of patients. However,
this doesn't mean Prozac can't cause withdrawal reactions.
SSRI withdrawal should always be done in small, incremental
amounts, like five to ten percent reductions per week. Never
start SSRI withdrawal by cutting daily dosages in half or
begin taking a daily dosage every other day, says Tracy.
Now over a decade into the Prozac era it has become
safe even for mainstream critics of SSRI's to speak out about
the dangers of these drugs. In his 2000 book Prozac Backlash:
Overcoming The Dangers Of Prozac, Zoloft, Paxil, and Other
Antidepressants With Safe, Effective Alternatives, Harvard
psychiatrist Joseph Glenmullen reaches basically the same
conclusions about the dangers of SSRI's Breggin and Tracy had
a decade before he published his book. The main value of
Glenmullen's book is his extension review of recent
peer-reviewed scholarly investigations into the adverse side
effects caused by SSRI's that have been conducted throughout
the '90s and his accounts of the adverse reactions patients
have experienced while on SSRI's in his private practice.
Glenmullen is an advocate for psychotherapy but he is not a
complete opponent of psychiatric drugging like Breggin and
Tracy are. Also, his position as a faculty member at Harvard
makes it more difficult for Lilly to charge that criticism of
SSRI's is part of a campaign against psychiatry inspired by
the usual suspects.
Not only should patients taking
SSRI's be made aware of the potential for increasing their
risk for suicide while taking these drugs, writes Glenmullen,
they should also be made aware of the permanent neurological
damage these drugs can cause. The title for Glenmullen's book,
Prozac Backlash, is the term he uses to describe how the body
compensates for the increased level of serotonin when patients
begin taking SSRI's. The body responds by decreasing its
production of the neurotransmitter dopamine, which has been
linked with loss of control of involuntary muscles, including
up to full blown Parkinson's in some cases. This indirect
effect on dopamine ends up creating side effects in SSRI's
similar to those produced by a previous generation of
psychiatric drugs.
Thorazine was the most popular of a
previous generation of drugs known as "neuroleptics," or
"anti-psychotics." Thorazine and the other tranquilizers
suppress dopamine directly, whereas the SSRI's are believed to
affect it indirectly. Approved for commercial use in treating
schizophrenia in the mid-50's, Thorazine would go on to become
th Prozac of its era, with 50 million U.S. patients having
been prescribed the tranquilizer by 1965. Eventually, an
estimated 250 million people worldwide would be exposed to the
major tranquilizers. The appearance of Parkinson's like tics,
or loss of control of involuntary muscles in the face and
extremities, by patients on SSRI's is why these drugs are
suspected of indirectly suppressing dopamine. Thorazine was
never pulled from the market and only received a stricter
warning label in 1985, after thirty years on the market and
long after most of the patents on the major tranquilizers had
expired. It was too late for the patients who had suffered
permanent neurological damage from long term use of the these
drugs.
Glenmullen also documents the links between
SSRI's and sexual dysfunction. Not only have patients on
SSRI's reported loss of sexual function, writes Glenmullen,
some have reported penile and vaginal anesthesia, or complete
loss of sensation in genital areas.
Dr. Dunner:
The Pharmaceutical Industry's Man At UW
Carol
Ostrom's front page article in the June 21 Seattle Times
reported the findings of a study by Express Scripts, a large
pharmacy-benefits manager for major corporations,
investigating anti-depressant drug use nationwide. The study
found Washington state ranks fourth nationally in per capita
anti-depressant drug sales. The only expert source for the
story was psychiatrist Dr. David Dunner, director of the
University of Washington's Center for Anxiety and Depression.
In the article Dunner says that doctors in Washington state
are not recognizing depression nearly enough and, therefore,
are allowing it to go undiagnosed and untreated. Dunner
concludes that "the fact we're No. 4 in the nation is a good
sign," but this high ranking is occurring "in a climate of
terrible undertreatment and underrecognition." Meanwhile, the
June 13 Wall Street Journal reported an 800% increase in
anti-depressant drug sales since 1990, having reached $10.2
billion in 2000.
Just who is Washington state's high
ranking in anti-depressant drug sales good for? The patients
who keep getting prescribed these drugs with little or no
warning of the dangerous side effects these drugs produce? Dr.
Dunner's ability to keep winning drug industry financed grants
for his department? Ostrom could have easily asked Dunner
these questions and more because of his position as a
professor at a publicly funded university. Virtually
everything he does is available through public records
requests at UW. Dr. Dunner refused to be interviewed for this
article about the safety and efficacy of SSRI's and his links
to the drug companies who help fund his department.
Dunner conducts clinical trials with psychiatric drugs
for drug companies. He was one of the lead investigators into
one of the trials that lead to Prozac's approval by the FDA in
the 80's. Dunner found in the trial he lead that "there was
essentially no difference in efficacy between fluoxetine
(Prozac) and placebo."
A year before Dunne took part
in the FDA hearing into Prozac safety in 1991 described above,
he had given a presentation for doctors on depression at a
workshop sponsored by Lilly. A report on his presentation in
Psychiatric Times describes Dunner as citing Teicher's study
on intense suicidal preoccupation in response to Prozac. The
report, summarizing Dunner's remarks, states, "While there is
no evidence from controlled studies to support these findings,
close clinical monitoring is advisable." Breggin argues in
Talking Back To Prozac that it would have been helpful if the
FDA and/or Dunner had made any of his past remarks or his
finding of failure for Prozac in the clinical trials known
during the hearing.
"He (Dunner) is the main reason
Washington state is number four on that list (of
anti-depressant drug sales)," says Dr. Tracy. "He is the
biggest drug pusher in Washington state." Tracy sees Dunner as
little more than a shill for drug companies, who pushes their
drugs on patients without informing them of their potentially
dangerous side effects. Dunner's fundraising from Eli Lilly
from 1982 up to 1991 mentioned above is documented by Tracy in
her book. Not much has changed in this regard since then.
Records obtained from the University of Washington show that
Dunner has received 253 grants and contracts awards since 1992
totaling $6,119,371. The majority of these grants and
contracts awards have come from drug companies, including 16
awards from Bristol-Myers Squibb since 1995 totaling $285,640,
22 awards from Eli Lilly since 1992 totaling $583,278 and 20
awards from Forest Laboratories since 1998 totaling $212,624.
Dunner's links to the drug industry is hardly a revelation
about a medical academic. What is more revealing though is
investigating how these relationships might affect what he is
willing to say in public as opposed to what he says among his
fellow academics.
Dunner would not be interviewed for
this article and Carol Ostrom's Times article does not mention
the side effects SSRI's produce. However, at about the same
time Dunner was being interviewed by Ostrom he had just
published an article with six other researchers in the June
issue of the Journal of Clinical Psychiatry. Much of the
record of the adverse side effects SSRI's can cause in
patients has been recorded in boring, sleep-inducing academic
journals like the JCP. Journalists, much less the public,
never look at the contents of these kinds of publications when
they interview big name researchers like Dunner. The title of
Dunner's latest published article in the JCP is eye opening to
say the least: "Efficacy and Safety of Mirtazapine in Major
Depressive Disorder Patients After SSRI Treatment Failure: An
Open-Label Trial." The real kicker here though is what Dunner
and his fellow researchers write in the opening two sentences
of the article: "Approximately 29% to 46% of depressed
patients show only partial or no response to an initial course
of treatment with antidepressants. Lack of efficacy and
intolerance are frequent causes of treatment failure or
discontinuation."
At the same time Dunner was telling
Ostrom at the Times how good it is that Washington state ranks
fourth nationally in anti-depressant sales and of the need to
prescribe these drugs more often, he had published an article
with six other researchers basically saying that Prozac and
its clones don't work. Perhaps Dunner could argue that a
majority of patients taking SSRI's still benefit from them
based on the statistic cited in his article. However, when
approximately one in four to one in two patients on these
drugs can't stay on them due to lack of efficacy and
intolerability, no reporter should be stating that these drugs
produce few side effects. Given this statistic, nobody could
argue that such drugs are the miracle cure-all drug
manufacturers claim they are.
It should be noted here
that this statement was not necessarily being made in the
interest of science or in informing patients of the dangers of
SSRI's. The study was funded by Organon and its purpose was to
investigate the efficacy and safety of switching patients from
an SSRI that isn't working for them to mirtazapine, or what is
known commercially as the non-SSRI Remeron. Organon is the
manufacturer of Remeron. Organon is a unit of the
multinational concern Akzo Nobel. Dunner has been awarded four
grants from Akzo Nobel-Organon since 1996 totaling $95,442.
"It is not uncommon these days for drug companies to
have control over the distribution of the information in the
research they fund," said Keith Hoeller of the Northwest
Center for the Study of Psychiatry and Psychology in Seattle,
which is affiliated with Breggin's organization in Maryland.
Hoeller edits the peer reviewed publication Review of
Existential Psychology and Psychiatry. "Many contracts for
research now come with clauses stipulating company control
over research results. This gives the company the power to
withhold information found in studies they don't want the
public to see. This gives researchers an incentive to find
results their funders are looking for."
Not
surprisingly, Dr. Dunner and his six co-authors in the JCP
article concluded that, yes, "Our results also indicate that
switching to mirtazapine is a safe and effective approach for
depressed patients who do not respond to or do not tolerate
SSRI's." This is the kind of industry-backed boosterism
journalists love to swallow in stories about these drugs
because the companies know that journalists almost never read
the studies they derive such claims from. The truth is that
Remeron didn't prove to be a better treatment option than
SSRI's in the study.
Of the 101 subjects who
participated in the study, 43 dropped out prematurely, with 26
subjects reporting adverse reactions and 17 for other reasons
(e.g. lost to follow up). Only 44 of the study subjects
responded positively to Remeron treatment. Given the stated
standard Remeron is being compared against, a 29 to 46 percent
failure rate for SSRI's, a 43 percent drop out rate, with 26
percent reporting ad erse reactions, is hardly a ringing
endorsement for the drug.
The most alarming adverse
reactions to Remeron by subjects in the study were from 16 who
reported psychiatric symptoms. Three reported aggravated
depression and two reported mania. These kinds of reactions
might include violence and suicide but we can't know this
because the study excludes those categories as possible
adverse reactions. Also, one subject reported a coronary
artery disorder, or a heart problem, as a reason for quitting
the study. These kinds of adverse reactions should not be
taken lightly in a study with only 101 subjects. If Remeron is
eventually prescribed to 10 million patients and only 1
percent of them experience violent and/or manic reactions
while on the drug, then up to 100,000 violent acts and/or
suicide attempts could happen as a result. A similar scenario
could unfold in the area of emergency room visits if the drug
consistently causes heart problems in a minority of patients.
Remeron was approved for commercial use by the FDA in
1996 and it was touted by Organon as a new breakthrough in
drug treatment for mental illness. Remeron is known as an
"NaSSA," or "Noradrenergic and Specific Serotonin
Antidepressant." In other words, the drug affects both
noradrenergic and serotonergic neurotransmitter systems. The
main selling point for Remeron is that it does not cause the
same side effects experienced by patients using SSRI's, like
insomnia, nervousness and sexual dysfunction. Given the
experience of patients on SSRI's for the past 13 years and the
fact that these claims are coming from the drug's
manufacturer, the public should take these claims with a high
degree of skepticism. The same theory of "selectively"
inhibiting and/or increasing the presence of certain
neurotransmitters is being used here. Even Dunner's study
found 20 of 101 patients experienced nervousness and 11 of 101
patients experienced insomnia while on Remeron. These are very
high numbers for a trial involving only 101 patients, which
lasted only a maximum of eight weeks. Even if Remeron proves
in clinical practice to be less likely to produce insomnia and
nervousness in patients than SSRI's, such a high incidence of
these adverse reactions in such a small body of patients over
such a short period of time suggests that Remeron is hardly a
long term solution to the adverse reactions experienced by
many patients taking SSRI's.
And what about the
potential for Remeron causing violence and suicide since the
study entirely avoids this issue? Remeron is relatively new
and it must compete with an alphabet soup of other psychiatric
drugs so not nearly as much is known about its adverse
reactions when compared with SSRI's. Breggin describes a man
who assaulted and a murdered his wife while on Remeron in The
Anti-Depressant Fact Book. Outside of this case, there isn't
much information in the public domain about the adverse side
effects experienced by patients on Remeron. One can only
speculate what patients might experience if they are switched
en masse from SSRI's to Remeron.
There wouldn't be any
reason to be concerned about Dr. Dunner's JCP article but
companies like Organon use these studies they fund to tout the
efficacy and safety of their drugs. There is too little
skepticism in the media and the public about claims made about
the wonders of prescription drugs precisely because very
little, if any, attention is paid to the fact that the vast
majority of clinical research into prescription drugs is
designed and funded by the drug companies themselves.
So why wouldn't Dr. Dunner be interviewed for this
article about the adverse side effects to SSRI's in patients,
while he was more than willing to co-author an article stating
the fact that SSRI's produce plenty of side effects? Given the
funding source of the study, a manufacturer of a drug being
marketed as an alternative to SSRI's, doesn't this give Dr.
Dunner the appearance of a scientist for hire? Breggin notes
in Talking Back To Prozac that Dr. Dunner receives honoraria
from Lilly for speaking engagements in addition to supervising
pharmaceutical industry grants for his department. That was
1994 but there is no reason to believe Dr. Dunner isn't
receiving honoraria from drug companies for making speeches at
industry sponsored events in 2001.
What does Dr.
Dunner tell his patients and subjects about the potential
dangers of SSRI's, including extreme agitation, insomnia,
sexual dysfunction and possible violence and suicide? If Dr.
Dunner won't discuss these issues publicly, then the funding
sources of his department must be considered a factor in this.
Also, Dr. Dunner can't be unaware of Dr. Healy being turned
down for a job at the University of Toronto and the belief it
happened because Healy hasn't shied away from linking Prozac
to suicide.
Conclusion And Prospects
Perhaps the most culturally detrimental aspect of
Prozac's reputation as a therapeutic agent is its ability to
raise the profile of dangerous street drugs and discredited
prescription drugs. At the beginning of chapter 2 in The
Anti-Depressant Fact Book, Breggin describes an article in the
New York Times Magazine noting the similarities between the
street stimulant Ecstasy and Prozac. The writer dismisses
government research into the potential dangers of the Ecstasy
because its effects on users are similar to that of Prozac. He
reminds the reader that "Prozac style anti-depressants produce
some morphological (structural) abnormalities in the serotonin
nerve network of rats that resemble changes seen with Ecstasy
taken in high levels. Yet few people advocate the banning of
Prozac." Instead of reaching the conclusion that perhaps the
public should be made more aware of the dangers of Prozac, the
writer extolls the virtues of the Ecstasy.
In an ABC
News article published on the Internet on March 22, 2001
reporter Robin Eisner writes about current research into
medical hallucinogens, including LSD, that could eventually be
prescribed to the mentally ill. Despite the long-term damage
LSD did to users in the '60s counter-culture, like in the
Haight-Ashbury scene in San Francisco, medical research into
hallucinogens is now being taken seriously because of Prozac's
high profile as a prescription drug.
It is now
becoming increasingly difficult for Prozac's defenders to
claim that it is essentially a safe, effective drug. There is
nothing knew about this, writes Glenmullen in Prozac Backlash.
Glenmullen discusses what he terms the 10-20-30 year life span
pattern of prescription drugs. This is a process whereby drug
companies and drug proponents unequivocally defend the safety
and efficacy of prescription drugs in the first decade of
their marketing. As time goes by and more research into a
drug's dangers becomes available, regulators and professional
organizations eventually have to take steps to curb over
prescribing of popular prescription drugs. This cycle is
usually completed after a certain class of drugs has been on
the market for about 30 years.
This was the case with
Thorazine. The FDA only required a stricter warning label for
the drug in 1985, years after the damage the drug could do had
been confirmed in research and after 30 years on the market.
The manufacturer of the drug, Smith, Kline & French, never
stopped extolling the medical value of the drug. In 1990,
after more than three decades of harming patients with
irreversible neurological damage, the company shamelessly
advertised Thorazine's 35th year on the market with the slogan
"Trust 35 Years Of Proven Experience."
The kind of
scientifically dubious testing and marketing of these drugs
will continue as long as the public allows the FDA to function
as little more than a subsidiary of the drug industry. The
agency, like so many others in Washington D.C., is filled with
officials with past financial links to the drug industry. Many
FDA officials use their jobs as a springboard for more
lucrative jobs in the private sector after leaving the agency.
Glenmullen describes the case of Paul Leber, the FDA's
director of Neuropharmacological Drug Products, which was
responsible for approving Prozac and led the investigation
into Prozac safety in 1991. Leber was an adamant defender of
Prozac and in the late '90s joined a consulting firm that
specializes in advising drug companies looking to gain FDA
approval for new psychiatric drugs.
The FDA will
continue to be the lax regulatory agency it is for the
foreseeable future. As long as this remains the case, drug
companies will continue to market new drugs as scientific
break throughs with few side effects. The fact that these
kinds of advertising claims will be made in light of a
complete lack of long term testing of new drugs will continue
as well. As long as the drug companies hold the keys to the
FDA, we can expect the public to be unknowing guinea pigs for
much of the research that discovers the long term adverse
effects of prescription drugs. None of this will change unless
the public demands and financially supports a tough FDA that
does long term te ting on new drugs before they are approved.
If that had been done in the case of SSRI's, most if not all
them might never have been approved by the FDA. Even if they
had been approved after long term testing, they would have
come to market with such a strict warning label that most
patients who have taken the drugs might not have risked the
damaging side effects.
What of Dr. Dunner at UW? Well,
he is what he is because the people of Washington state allow
him to be that way. With the state's budget having been
whittled to the bone over the past several years, Olympia can
barely fund our public universities and community colleges
anymore. This means that public institutions of higher
learning in Washington state will have to rely on even more
private funding to stay afloat financially in the near future.
As long as Washington state residents refuse to pay the taxes
necessary to fully support public universities, Dr. Dunner
will continue to raise money from drug companies and conduct
research funded by them. As long as journalists continue to
ignore where Dr. Dunner receives his funding and the industry
funded science he authors in scholarly journals, they will
continue to quote him as an unbiased authority on psychiatric
drugs. This will have to change in order for more accurate
information about SSRI drugs to reach the public.
Finally, what of the documenting of the stories of
patients who have experienced adverse reactions to SSRI's Dr.
Tracy is conducting in Utah? Whose perspectives on the dangers
of SSRI's would we find more reliable? Many of the stories Dr.
Tracy has documented in Prozac: Panacea or Pandora? and will
be documenting in three upcoming books will be based on
anecdotes. This approach to documenting adverse side effects
to SSRI's comes with some limitations no doubt. But what of
the testing into the FDA approval for Prozac? Most of the 286
subjects who even finished the trials only took the drug for
four to eight weeks. Even thou |
See also:
http://www.ucimc.org/newswire/display_any/1761/www.drugawareness.org
|
Comments
| no suck thing |
by chris mankey
whovian222
(nospam) aol.com (unverified)
|
Current rating: 0
15 Jan 2004
|
| No such thing as a safe and effective
drug, what kind of moron is this woman! I guess my grandmother
is addicted to her high blood presure medication! I Feel sorry
for people who are this stupid. |
|
