Marijuana.com

Lyte it up 420

I know this doesn't have anything to do with weed but I've noticed alot of people on here that take anti-depressants, so figured it was worth a post.

Prozac Nation? Is the Party Over?

Fri Aug 20,11:53 AM ET



By Richard C. Morais

Nancy Hugo, a 57-year-old housewife in Corvallis, Ore., had recently been
prescribed the antidepressant Zoloft by her internist when she found herself in
the bathroom, looking at a Bic shaver and wondering if she could get the blade
out of its plastic. In the living room she zeroed in on a pair of long
scissors she had inherited from her grandmother. "I kept on wanting to pick them
up and gouge my eye out," she recalls. Trying to occupy her mind at the computer,
she fought the "urge to slam the phone into the side of my head."

About to Crash?

America's top-selling antidepressants could soon experience a downturn. Now
off-patent, Prozac is no longer a bestseller.

Top five antidepressants

Drug Manufacturer 2003 sales*($bil)

Zoloft Pfizer $2.9

XR Effexor Wyeth 2.1

Wellbutrin SR GlaxoSmithkline 1.8

Paxil GlaxoSmithkline 1.5

Celexa Forest Laboratories 1.4

*Wholesale prices of drugs, not including mail service. Source: IMS Health.

Hugo survived the weekend; her drug doses were reduced and she was switched
to antidepressant Paxil. This time, however, she experienced akathisia'a
medicine-induced agitation and restlessness that some patients on
antidepressants describe as the feeling of bugs crawling through the skin'and an extreme bout of mania. "What spooks me now is that I thought I'd recognize when I was having trouble with the medications," she says. "But it was a week later before I realized, 'Oh, my God, what have I done?'"

Both Zoloft and Paxil are Prozac-type drugs known as SSRIs, or selective
serotonin reuptake inhibitors. Do such drugs cause mania and violent obsessions?

That question is now being debated in many a doctor's office, court of law and
legislature. Whatever the correct scientific answer, the mere fact that the
question is being asked represents a new phase in the evolution of SSRI
medications and a threat to the well-being of the companies that make the drugs.

Since SSRIs arrived 16 years ago with the introduction of Eli Lilly & Co.'s
Prozac, the category has expanded into a collection of blockbusters for Lilly,
Pfizer, GlaxoSmithkline and other manufacturers. All told, the antidepressants
category accounts for $14 billion a year of wholesale revenues just in the
U.S., according to IMS Health. In the first five months of this year American
doctors wrote 46 million prescriptions for antidepressants, up 5% over the same
period last year, according to NDCHealth. Yes, this is a Prozac nation. Dr.
Mark Vanden Bosch, an anesthesiologist at the Berkshire Medical Center in
Pittsfield, Mass., who must be alert to drugs that might interact with
anesthesia, estimates that a third of the patients checking into his hospital, for a wide range of operations, are on antidepressants.

When Prozac was new, it was heralded (in, for example, the 1993 hit Listening
to Prozac) as a wonder drug with little in the way of side effects. The few
naysayers were for the most part fringe sorts like Scientologists. Now a giant
pall of misgiving is descending on SSRIs: Tearful family members are telling
their congressmen how the drugs caused their children to commit suicide;
Britain has limited their use in children; a suit by New York Attorney General
Eliot Spitzer claims GlaxoSmithkline suppressed evidence that the drugs don't work
in children and can endanger them; and the Food & Drug Administration is
studying whether it should mandate ominous warning labels.

It's a pattern we have seen before in psychiatric drugs, says Harvard Medical
School (news - web sites) psychiatrist Joseph Glenmullen. A new class of
chemicals creates a wave of euphoria in the medical community, while a handful
of celebrities (such as, in the case of SSRIs, Mike Wallace of 60 Minutes) swear
by the new pills. A decade later reports of side effects accumulate and
doctors begin to have second thoughts. Another decade later the world discovers
a new miracle drug and the old one is relegated to niche uses. It happened to the
major tranquilizers (like Thorazine) introduced in the 1950s, and it happened
to supposedly less addictive and relatively side-effect-free substitutes for
morphine. Dr. Glenmullen made this point about the SSRIs five years ago in his
book Prozac Backlash. He looks prescient now.

The touchiest issue is whether SSRIs provoke suicides in children. Eric
Harris was on Solvay Pharmaceuticals' SSRI, Luvox, when he and Dylan Klebold
went on their murder-suicide rampage through Columbine High School in Littleton,
Colo. in 1999. Did the powerful drug push him into a dangerous mental zone, like the one Hugo experienced, or was it unable to stop what was already there?
It's hard to know. (A Columbine survivor's lawsuit against Solvay was settled
out of court, without any admission of liability, and resulted in a token
contribution from Solvay to a charity.) The British health authorities have
ruled that the side effects of SSRI antidepressants other than Prozac put children at
an unacceptable risk of suicide. The National Institute of Mental Health in the
U.S., in contrast, says that "some research" points to a drop in suicides
among children since the drugs were introduced, "but it is not known if SSRIs
are directly responsible."

"The suicides under SSRIs are violent," says Vera Sharav, president of the
Alliance for Human Research Protection, a group headquartered in New York City
that is crusading for full disclosure of the drugs' side effects. "It's not
like someone going into the bathroom and taking pills. It's jumping, knives,
hanging. They're in pain. They're jumping out of their skins."

Glenmullen says he himself prescribes SSRIs when appropriate but is dismayed
to see patients who have been prescribed antidepressants for every triviality,
from nail-biting to boyfriend breakups. It is easy to see where
overprescribing could become a habit. General practitioners, internists and
family doctors are, at times, penalized by health insurers for making referrals to
psychiatrists. These first-line doctors write 73% of all antidepressant scrips
in America. Fact: We now spend more on mood-altering drugs for our children,
including antidepressants, than we spend on antibiotics.

Harried GPs do not always discuss with their patients such possible problems
as withdrawal symptoms on discontinuance or the need for ever-increasing doses
as the drug's efficacy wears off. In 1997 C.W. Tillman, a county official in
Missouri, had an anxiety attack and was prescribed Paxil by his doctor; a few
days later his adverse reactions included severe agitation, extreme
sensitivity to light and noise, claustrophobia, diarrhea and vomiting. His
doctor told him to stop taking the drug, let the symptoms clear up and start again. A month later Tillman had descended into a deep depression and took an overdose.

The brain runs on a cocktail of feel-good chemical transmitters, among them
adrenaline, serotonin and dopamine. Basically, serotonin flows across a synapse
briefly, from one nerve cell to another, after which the cell that sent it
out mops up the excess. SSRIs work by blocking the sending cell's ability to
reabsorb the excess serotonin. Result: The receptors in the second cell get a
prolonged bath of the feel-good juice. The miracle in this class of drug is that SSRIs are better tolerated than earlier antidepressants and less likely to be
fatal in an overdose.

Now the downside: The brain adjusts to the artificial increase in serotonin
with a compensatory drop in dopamine. No one knows the long-term effect of this
drop in dopamine in the brain. "The gaping loophole in our drug safety
system," says Glenmullen, "is long-term safety. It takes decades for enough
consumers to have had ill effects for problems to come to the authorities'
attention." Pfizer, the manufacturer of Zoloft, says it carefully monitors safety after
drugs are approved and shares that information with the FDA (news - web sites).

Doctors and patients have for some time been reporting mild tics and jerks in
SSRI users. The tics are usually overlooked, but can develop into tardive
dyskinesia (manifested by a freakish "involuntary tongue" that darts out of the
mouth, twitching or "running" legs, jerking or wildly swinging arms and
gagging). Do patients know they may be in for this? Knowing, they might, of
course, still opt for medication. "A little discomfort is a small (price) to pay for a
normal level of happiness!" writes Archibald Hart in Unmasking Male Depression.

Thorazine, it turns out, creates similar side effects, but it was a while
before doctors were aware of how frequently. Prescribed for everything from
insomnia to anxiety, this type of tranquilizer was taken by an estimated 250
million worldwide. In 1973, at the 20-year mark, 2,000 cases of tics had been
reported. Critics surfaced and were dismissed as alarmists. But by 1980
systematic studies using neurological screening tests discovered that 40% of all patients treated with the Thorazine class of tranquilizers had tics. Reclassified as
antipsychotics, the Thorazine-style drugs were given a long list of FDA warnings and are used today only for severe mental illness.

SSRI patients are also reporting memory loss. It's mostly anecdotal evidence
at this point. But Harvard's Glenmullen says the reports of memory loss, tics
and jerking side effects found in SSRI patients suggests to him the possibility of long-term brain damage. Is there a risk that, a decade hence, we
will see an epidemic of Alzheimer's- or Parkinson's-like diseases? The regulators
haven't given enough thought to the possibility, he says.

Whatever the true hazards in SSRIs, there is no doubt that tort lawyers can
make hay out of the situation. No overall litigation and settlement data are
available on antidepressants (opponents claim pharma is settling cases quietly
and sealing the records), and there are just the early signs of clustering
activity'trial lawyers advertising for SSRI "victims," seminars and other legal
teamwork'familiar to mass torts, but watch events gather pace.

"We went through a whole period of overprescribing SSRIs," says Jeffrey
Kodroff, a Philadelphia lawyer suing Pfizer over Neurontin, an epilepsy drug.
"When the market started getting to the point of saturation, the market started
emphasizing juvenile use, also for the purpose of getting patent extensions. If
the studies show they are not only not efficacious, but cause problems, you're
going to see a big backlash in usage of SSRIs."

The New York Attorney General's suit against GlaxoSmithkline, filed in June,
alleges that Glaxo committed fraud by suppressing or selectively quoting from
clinical studies that showed Paxil to be no better, or even worse, than a
dummy pill in treating children with depression. Spitzer has also requested
documents from Forest Laboratories, maker of SSRIs Celexa and Lexapro. Glaxo
says Spitzer's allegations are bunk; it never targeted kids.

To see what a successful Spitzer prosecution could provoke, look at what
recently happened to Pfizer. Warner-Lambert's Neurontin was FDA approved for
epilepsy, but the company, it was alleged, was encouraging doctors to prescribe
it for "off-label" uses like bipolar disorders. A whistle-blower triggered
federal and state criminal investigations into the marketing, and this May
Pfizer (which had subsequently acquired Warner-Lambert) settled with the government, taking a $427 million pretax hit in criminal and civil fines.

Four days after the settlement the Teamsters Health & Welfare Fund of
Philadelphia & Vicinity, joined by Aetna and the Alaska State Employees
Association health benefits trust, filed class actions against Pfizer alleging, among other things, that Warner-Lambert suppressed a Harvard Bipolar Research Program
study finding that "patients did worse on Neurontin than those who were on a
sugar pill." Two years after the study was suppressed, the Teamsters suit
alleges, "Neurontin accounted for $1.3 billion in sales, with over 80% of its use
coming from nonapproved uses, such as treatment of bipolar disorder." Pfizer
says it will "vigorously defend" itself against any suits following its Neurontin
settlement, and says "it is worth noting that those investigations did not r
esult in a charge of fraud by Warner-Lambert."

A user of SSRIs for almost a decade, who says she can't wean herself off the
drugs and spoke to us on the condition of anonymity, recently wrote her former
Park Avenue psychiatrist: "I simply pray Glaxo follows the path of (Dow)
Corning, who endangered women's lives with silicone implants they knew were
dangerous. Bankruptcy."

Even if Pfizer, Glaxo and Lilly are right about the science, they could be on
the wrong end of a tort suit. Look at the breast implant cases. Scientific
studies showed that there was no connection between silicone and the autoimmune
diseases supposedly caused by it. But still the implant manufacturers had to
spend billions of dollars to settle lawsuits.

__________________
Every living creature on earth dies alone.