10/26/2000 – Prozac: Unsafe at Any Price

Once again Arianna Huffington has said it like it is! Bravo!! I have
stated repeatedly that lack of insurance or poverty has saved
many a life because they cannot afford these drugs. What a
tragedy it will be if these drugs are made more affordable!

The only thing she neglected to include in the following article is
that it is George Bush’s father, the ex-president, we can thank for
giving us the SSRI antidepressants. It was during his
administration that laws were passed drastically reducing the
length of time needed in clinical trials for a drug to be approved
as “safe.” Prozac was approved on only 5 and 6 week studies.

Ralph Nader is the only candidate I am aware of that is
concerned about dangerous prescription drugs and has worked
to do something about them.

Ann Blake-Tracy, Executive Director,
International Coalition For Drug Awareness


Prozac: Unsafe at Any Price
Filed October 23, 2000

Al Gore, as he will tell you, and tell you, and tell you, is a “fighter.”
And among the many enemies he “fights” for us, he lists the big
drug companies. On the campaign trail, Gore repeatedly rails
against them, hoping to distinguish himself from George W.
Bush and prove his commitment to the “little people.” But at no
point does the vice president name any names or level any
specific accusations against the industry beyond the high prices
they charge seniors. Last week, though, we were reminded that
pricey prescriptions for gramps and granny are not the gravest
offense some drug companies are guilty of.
On Thursday, Eli Lilly announced it was halting development of a
new and improved version of Prozac, its top-selling drug. The
patent for the new formulation — which cost Lilly $90 million —
claimed it would reduce “the usual adverse effects” of the
original Prozac, including “nervousness, anxiety, insomnia, inner
restlessness (akathisia), suicidal thoughts, self mutilation,
manic behavior.” Just the usual.
But if you’re over 65, Al is fighting for you to at least enjoy these
side effects at a reduced price. Yet almost from the time it was
introduced in 1988, Lilly has been maniacally denying claims
that Prozac produces violent or suicidal reactions.
Could the recent startling reversal have anything to do with the
fact that Prozac’s extremely profitable patent — which brought Lilly
$2.6 billion last year — was set to expire in 2004? What’s more,
just this August, a federal appeals court shortened Lilly’s
exclusive patent by three years, allowing generic versions of the
mega-drug to hit the shelves next summer.
The damning admissions in the enhanced Prozac’s patent will
be the center of a federal lawsuit scheduled to go to trial in
Hawaii next summer. This will be the latest round in a legal
battle initiated by the children of a man who, while on Prozac,
fatally stabbed his wife and then himself (in other words,
“suicidal thoughts, self mutilation, and manic behavior”).
During the first trial, Lilly’s lawyers and witnesses repeatedly
claimed that violent or suicidal acts are not a side effect of
Prozac. In fact, the president of Lilly’s neuroscience product
group, Dr. Gary Tollefson, testified under oath: “There is
absolutely no medically sound evidence of an association
between … Prozac and the induction of suicidal ideation or
violence.” Clearly impressed with such expert testimony, the jury
found the drug company not liable for the murder-suicide.
The latest suit charges that “a fraud was committed on the court”
when Lilly failed to disclose the potentially explosive data
contained in the patent, which it had purchased three months
before the first trial began. “It is incredible,” said Karen Barth,
one of the attorneys suing Lilly, “that on the one hand, Lilly
vehemently argues to a federal judge and jury that Prozac does
not cause suicide and/or violence … while on the other, pays $90
million for a patent … which clearly acknowledges Prozac’s
propensity to increase the risk of suicide and violent behavior.”
If there was no problem with Prozac, then why spend all that
money to fix it? Lilly has faced over 200 Prozac lawsuits and has
yet to lose a case –opting to secretly settle the majority of them.
The patent disclosures could be the smoking gun that changes
all that. “The new patent can be compared to the tobacco
papers,” argues Dr. Joseph Glenmullen, a Harvard Medical
School professor and author of “Prozac Backlash.” “It’s a
pharmaceutical company document that acknowledges this
dangerous side effect, which has been downplayed by Eli Lilly
and other pharmaceutical companies for a decade.”
And the damning evidence against Lilly continues to mount. Last
spring, an investigation by the Boston Globe found that,
according to the drug company’s own figures, “One in 100
previously nonsuicidal patients who took the drug in early clinical
trials developed a severe form of anxiety …. causing them to
attempt or commit suicide during the studies.” And a recent
study by brain chemistry expert Dr. David Healy of the University
of Wales estimated that roughly “50,000 people have committed
suicide on Prozac,” people who wouldn’t have had they not been
on the drug. In the final debate, Gore criticized the
pharmaceutical companies for “spending more on advertising
and promotion” than on “research and development.” He’s right
about that: In 1999, each of the five biggest drug companies
spent more than double on sales and marketing than on R&D.
But once again Gore missed the point: The most egregious
aspect of the ads is the creation of an artificial demand for drugs
with side effects far more severe than the ailments they claim to
treat. The latest targets of Eli Lilly’s admeisters are women
suffering from “mood swings, irritability and bloating” brought on
by their monthly periods. The company’s solution: a new drug
called Sarafem, which comes in pretty little pink-and-lavender
pills. The company’s come-on: a marketing campaign urging
consumers to be “More like the Woman you are.” The company’s
secret: Sarafem isn’t really a new drug at all, only Prozac with a
makeover. But even more disturbing than the thought of millions
of already cranky PMS sufferers being pushed over the edge by
this re-packaged Prozac is the trend it exemplifies: the turning of
all of life’s little unpleasantnesses into clinical conditions that
require drugs purporting to get us back to our original perfect
selves. As Dr. Peter Kramer, author of “Listening to Prozac,” puts
it: “The implication is that the premenstrual self is inauthentic,
that irritability is incompatible with the female gender. And that
the truest state is the medicated one.”
Maybe Al Gore’s got it all wrong on health care. Instead of fighting
to make prescription drugs cheaper for people, maybe he
should fight to price certain drugs out of their reach — in an effort
to save their lives.

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