ANTIDEPRESSANTS ARE FAR FROM ALONE IN DANGERS! & BEWARE OF DRUG ADVERTIZING!

NOTE FROM Ann Blake-Tracy (www.drugawareness.org):
The following article on drug advertising, “Side Effects Include Denial” is an
EXCELLENT article on how the public is brainwashed into using drugs without a
thought. This is how we have ended up on all of these new “Designer Drugs” that
seem to be more the norm in our society now than the abnormal. When I was
growing up someone who was ill was out of the ordinary. Most we well. Now it
seems the exact opposite with even the very young discussing their serious
disorders – things we never saw in children before.

Although our site has focused on antidepressants for many
years, that focus has nothing to do with lack of concern over a myriad
of other deadly medications. The focus on antidepressants has been due to
the extremely widespread use of these drugs along with their potential to lead
the user to extreme out of character violence toward themselves or others
coupled with their potential to lead to many other drugs being prescribed for
the antidepressant side effects they suffer (new symptoms such as a
diagnosis for Psychosis or Bipolar Disorder, Panic or Anxiety attacks,
extreme insomnia, sleep apnea and other sleep disorders, Restless Leg Syndrome,
alcohol or nicotine use/abuse, diabetes, Fibromyalgia, thyroid problems,
headaches, IBS, MS, Chronic Fatigue Syndrome, ADHD, etc., etc., etc.)
Many of the newer medications out there were designed specifically for the
increase in patients with these “symptoms” that are nothing more than
antidepressant side effects which would subside upon the safe withdrawal of the
individual from the offending medication – the antidepressant. And far too many

of these new drugs are just remakes of antidepressantsfar too similar in
action to these drugs. One example would be Chantix’ similarity to Zoloft.
Sarafem, prescribed for PMS, is nothing more than Prozac with a new name and
different color capsule (pink to give it a feminine touch). Duloxetine
is the chemical name for Lilly’s Cymbalta and the name generally given to a
patient prescribed the drug for urinary incontinence so that they
remain unaware that it is really an antidepressant (antidepressants have LONG
been given to children for bed wetting). Yet another antidepressant is
prescribed for tuberculosis. Then there are all of the headache medications and
too many pain killers which all have serotonergic effects and can cause many of

the same serious adverse reactions that antidepressants cause.

WE URGE YOU TO USE EXTEME CAUTION, NO MATTER THE DRUG PRESCRIBED!!!
PRESCRIPTION DRUGS ARE KILLING FAR MORE NATIONWIDE THAN ILLEGAL DRUGS!! READ
ANYTHING AND EVERYTHING BEFORE EVER PUTTING A DRUG IN YOUR MOUTH!!! INSIST ON A
PACKAGE INSERT RATHER THAN THE SHORT HANDOUT ON THE DRUG PROVIDED BY THE
PHARMACACY WHCIH DOES NOT EVEN SCRATCH THE SURFACE IN GIVING YOU THE TRUE
WARNINGS REFLECTED IN THE PACKAGE INSERTS.
__________________________________________
But last July the Food and Drug Administration, which approved Chantix in
2006, said it had received 4,762 reports of “serious psychiatric events” —
including paranoia, homicidal thoughts, hallucinations, 188 attempted suicides
and 98 suicides — and it ordered Pfizer to put a “black box” warning on the
drug.
Pfizer’s not worried for the same reason that Bristol-Myers Squibb isn’t
worried about its Abilify ad, with piano music under, showing a happy family’s
outing to a pier, accompanied by a voiceover about seizures, thoughts of
suicide, risk of death or stroke. It’s why Sanofi-aventis, the manufacturer of
Ambien, doesn’t mind spending half an ad (sleeping lady, rooster, harp) warning
of side-effects like sleep-driving and sleep-eating. And it’s why
GlaxoSmithKline is unconcerned about undercutting the effectiveness of its Requip ad

for Restless Leg Syndrome (relaxing lady, crossword puzzle, strings) with
warnings about (this is my favorite) compulsive gambling.

http://www.huffingtonpost.com/marty-kaplan/side-effects-include-deni_b_463996.html

Marty Kaplan

Director, Norman Lear Center and Professor at the USC
Annenberg School
Posted: February 16, 2010 12:31 PM

Side
Effects Include Denial

Why would Pfizer spend $100 million on two-minute TV ads that use a minute of
that time admitting that their drug Chantix can cause “changes in behavior,
hostility, agitation, depressed mood,” “weird, unusual or strange dreams,” and
“suicidal thoughts or actions”?

Because they have to, and because it doesn’t matter.

With the patent on Pfizer’s cash cow Lipitor expiring next year, Chantix, a
smoking cessation pill, had been one of their big hopes for the future. Chantix
sales in 2007 approached $900 million; by 2009, it accounted for 90 percent of
smoking cessation prescriptions. But last July the Food and Drug Administration,
which approved Chantix in 2006, said it had received 4,762 reports of “serious
psychiatric events” — including paranoia, homicidal thoughts, hallucinations,
188 attempted suicides and 98 suicides — and it ordered Pfizer to put a “black
box” warning on the drug.

What to do? One tack Pfizer took was to launch a “help-seeking ad” that’s now running all over cable TV. You might easily mistake it
for a public service ad. As a voiceover reads sentences appearing on a black
screen, a match-flame turns the words to smoke: “You wanted to quit before you
got married… You wanted to quit before you turned thirty-five. You wanted to
quit when you had your first child.”

At the end, you’re invited to go to MyTimeToQuit.com, which takes you not to
the Surgeon-General or to the American Cancer Society, but to a Pfizer site that
in turn leads you to Chantix. There’s no legal requirement to include the
suicide warning on the faux-PSA, because it never mentions Chantix by name.

Pfizer’s other marketing tactic was to air a testimonial. We spend two
minutes getting to know Robin, a real-life success story. In her kitchen, over a
lovely soundtrack, Robin tells us how Ben, one of her boys, asked her to stop
smoking. Her doctor prescribed Chantix. As she and her family walk around a
neighborhood of gracious lawns and fall foliage, we hear what good support and a
good drug can do. Back at home, her husband makes coffee while she slices apples
and cheese for a snack at the kitchen table. Radiant, laughing, she says that
Ben finally tired of counting the days since she quit. At the end, an
announcer’s voiceover invites us to “talk to your doctor to find out if
prescription Chantix is right for you.”

But wait a minute — literally. During half the ad, that same announcer is
also telling us about the mental health problems that can be worsened by
Chantix. Not once, but twice, he says what should be alarming words: agitation,
hostility, depressed mood, suicidal thoughts or actions. The words appear yet a
third time in the same ad, in a boxed text at the bottom of the screen.

Why isn’t Pfizer nuts to spend so much money scaring us to death about their
product? While Robin is slicing that apple, why isn’t Pfizer worried that the
voice warning about suicidal thoughts or actions will make us fret whether it’s
safe to let Robin be around sharp objects?

Pfizer’s not worried for the same reason that Bristol-Myers Squibb isn’t
worried about its Abilify ad, with piano music under, showing a happy family’s
outing to a pier, accompanied by a voiceover about seizures, thoughts of
suicide, risk of death or stroke. It’s why Sanofi-aventis, the manufacturer of

Ambien, doesn’t mind spending half an ad (sleeping lady, rooster, harp) warning
of side-effects like sleep-driving and sleep-eating. And it’s why
GlaxoSmithKline is unconcerned about undercutting the effectiveness of its Requip ad
for Restless Leg Syndrome (relaxing lady, crossword puzzle, strings) with
warnings about (this is my favorite) compulsive gambling.

Pictures are more powerful than words. Language and logic don’t have the kind
of immediate access to our brains that images and instruments do. Feeling comes
before thinking. We can be as skeptical about marketing as we like, but media
literacy isn’t much of a match for music. No wonder Plato banished the poet in

The Republic: he couldn’t think of a curriculum that could protect people from
being enthralled by fiction, spellbound by illusion. The bards who sang the
Homeric epics were the ancestors of today’s Mad Men.

Robin’s harmless kitchen knife brilliantly neuters the suicide warnings, as
does the rest of her happy-ending story. In 2005, Duke University researcher Ruth Day presented a study to the FDA demonstrating how ads
can use distracting images and music to minimize attention to risk warnings. Her
infamous example: the fast-fluttering wings of the Nasonex bee (voiced by
Antonio Banderas) prevented viewers from remembering the side effects
information. Partly as a result, last May the FDA issued draft regulations declaring that ads will be judged by their
net impression as a whole, not just whether they’re technically accurate.

Pfizer denies that increased regulatory oversight led them to
raise the time devoted to safety warnings in its Chantix ads from 14 seconds to
a minute. I suspect they could run a two-minute crawl about suicide risks, and
it still wouldn’t distract from Robin’s heartwarming testimonial. We’re suckers
for mini-movies. No wonder the corporations just unleashed by the Supreme Court
to spend unlimited funds on campaign ads are salivating at the opportunity to
enthrall us.

This is my column from The Jewish Journal of Greater Los Angeles.
You can read more of my columns here, and e-mail me there if you’d
like.

Follow Marty Kaplan on Twitter: www.twitter.com/martykaplan

626 total views, 1 views today

SARAFEM (PROZAC) & ROBITUSSIN: Brittany Murphy Dies Suddenly: CA

NOTE FROM Ann Blake-Tracy
(
www.drugawareness.org): Brittany
Murphy died from the use of multiple serotonergic medications – meds that
increase serotonin. She may have had pneumonia, but pneumonia does not kill that
quickly. There were clearly other contributing factors when death is so sudden
and without much warning.

When Heidi Connelly published her information on Fen-Phen and Redux causing
heart valve problems (something Brittany already suffered from) she found that
it was the elevated levels of serotonin produced by the Fen-Phen and Redux that
caused a gummy gooey glossy substance to build up on the heart valves and keep
them from shutting properly. So if Brittany‘s heart valve already did not shut
properly and you raise her serotonin levels with two serotonergic drugs – Prozac(Sarafem) and Robitussin you build the level of gummy gooey glossy substance on
that heart valve and you are in trouble.

But beyond that the increase in serotonin constricts muscle tissue
restricting air into the lungs, blood flow throughout the body, etc. – all the
major organs are constricted by elevated serotonin. When the serotonin level
gets too high (as it does when you mix two meds that increase it) you produce
death via multiple organ failure. This is what killed Daniel, Anna Nicole
Smith’s young son. It is called Serotonin Syndrome.
So, in Brittany‘s case I firmly believe that the elevated serotonin
produced by these drugs put the nail in her coffin.
Paragraph four reads:  “Investigators found prescription
medication for depression, seizures, anxiety and pain. Monjack told Lauer his
late wife used Vicoprofen and Sarafem during her menstrual
cycle. ‘”Most of the medications are mine. I suffer from seizures,’
Monjack declared. The screenwriter began to stutter and added,  ‘I suffer
from, you know, heart… my heart stopped on December 3rd when we landed from
Puerto Rico’.”
SSRI Stories note:  Sarafem is, molecule for
molecule, the same exact drug as Prozac.  It goes by a different name
because it is registered with the FDA for use in PMS.

http://extratv.warnerbros.com/2010/01/brittany_murphys_family_continues_to_deny_drug_rumors.php

Brittany
Murphy‘s Family Continues to Deny Drug Rumors

Posted on January 21, 2010Brittany Murphy‘s
husband and mother sat down with Matt Lauer on the “Today” show to
discuss the actress’ sudden death.

Murphy

died Dec. 20, and the cause of death is still unknown; toxicology
results
are expected in a few weeks.

“Let’s set the record straight
once and for all — Brittany was not taking any medication for her mood, for
anorexia,” Murphy‘s husband Simon Monjack said. “It’s utterly ridiculous
that these rumors have perpetuated.”

Investigators found prescription
medication for depression, seizures, anxiety and pain. Monjack told Lauer his
late wife used Vicoprofen and Sarafem during her menstrual cycle. “Most of the
medications are mine. I suffer from seizures,” Monjack declared. The
screenwriter began to stutter and added, “I suffer from, you know, heart… my
heart stopped on December 3rd when we landed from Puerto Rico.”

See

Brittany‘s life in photos

Murphy‘s mother Sharon began to
shake her head when Lauer asked about Brittany‘s rumored cocaine use. “It’s just
so horrific. She was diagnosed with a heart murmur when she was a young teenager
and she was terrified of anything happening to her. She never did any drugs,
ever.” Sharon replied.

The two also denied Brittany had any type of
eating disorder. “You just need to go to her favorite restaurant, Chateau
Marmont, and speak to any waiter, who would tell you that she would happily
order four plates of food and eat them all,” Monjack stated.

Monjack
also claims Murphy‘s role in “Happy Feet 2” was pulled and it broke her heart.
He explained, “Hollywood is a village and once you upset the villagers they talk
and they gossip and they rumor. They have blood on their hands, and I hope they
wash them with very hot water because of the way they treated Brittany Murphy

while she was alive.”

The grieving husband and mother have established The Brittany Murphy
Foundation
in her memory.

826 total views, no views today

Brittany Murphy Cause of Death? Serotonin Syndrome?

NOTE FROM Ann Blake-Tracy:

Brittany Murphy‘s husband and mother are saying they do not think Brittany
died as a result of the drugs she was taking. Let me explain why they are wrong.
What a shame they do not have this information.

#1 Brittany had mitral valve prolapse where a heart valve does not close
properly like the drugs Fen-Phen and Redux produced that killed so
many people. And what did Dr. Heidi Connelly from the Mayo Clinic find that
these drugs did to produce the heart valve problem?

She found that it was the increased levels of serotonin produced by
the drugs that caused a gummy gooey glossy substance to build up on the heart
valves so that they could not close properly.

What do Prozac (Sarafem) and Robitussin both increase? Serotonin levels
and taken together they can produce serious reactions or even kill you due to
the elevated levels of serotonin the mix of these two drugs can
produce.

#2 The day after Brittany died a new study was released demonstrating an
increase in heart failure for women taking antidepressants and anti-anxiety
medications. Brittany was on both Sarafem (Prozac marketed for PMS) and Klonopin
(an anti-anxiety medication – not sure who told Brittany‘s husband that this
drug is an anti-seizure med).

#3 Flu-like symptoms are often symptoms of a toxic reaction to medications.
This is never stressed enough to patients! In treating the flu-like symptoms,
that could easily have been a toxic reaction to meds, with Robitussin which
contains the serotonergic agent dextromethorphan, it could have pushed Brittany
over the edge leading to multiple organ failure that comes from elevated levels

of serotonin – the same thing that killed Anna Nicole Smith’s young son,
Daniel.

________________________________________

Murphy had mitral valve prolapse, a common condition where a heart valve does
not properly close, but doctors said the actress “would live a long and healthy
life,” Monjack said.

He said his wife took the anti-seizure medication klonopin ever since an
episode she had while filming “8 Mile.” She also occasionally took Sarafem, a
drug aimed at pain and mood swings during menstrual periods, Monjack said.

He said he did not think a harmful interaction of drugs played a role in his
wife’s death. She had been sick with flu-like symptoms in the days before her

death and had been taking Robitussin, but nothing more, he said.

Brittany‘s mom, husband say drugs didn’t kill her

By ANTHONY McCARTNEY | Posted: Wednesday, January 20,
2010 9:35 am | No Comments Posted

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Simon Monjack, left, husband of deceased actress Brittany
Murphy and Murphy‘s mother Sharon pose with a portrait of the actress in Los
Angeles, Tuesday, Jan. 19, 2010. Monjack said the portrait by photographer Bruce
Weber was Murphy‘s favorite photo of herself. (AP Photo/Chris
Pizzello)

A month after Brittany Murphy‘s mysterious death, her mother and husband say
they are convinced the actress died of natural causes, not drugs or an eating
disorder.

In an interview with The Associated Press on Tuesday, Sharon Murphy and Simon
Monjack said that Murphy did not use drugs or alcohol and that they are awaiting
a determination from coroner’s officials that will end speculation prescription
medicine caused Murphy‘s death on Dec. 20 at age 32.

Monjack said some of the prescription medications found in the couple’s
Hollywood Hills home belonged to him.

Murphy had mitral valve prolapse, a common condition where a heart valve does
not properly close, but doctors said the actress “would live a long and healthy
life,” Monjack said.

“She had a fear of dying,” Sharon Murphy said. “She would not take too much
caffeine. She wouldn’t even have a glass of champagne on New Year’s. She was
just high on life, and people see that as something else I guess.”

Murphy, the star of varied films such as “Clueless,” “8 Mile,” “Sin City” and
the television series “King of the Hill,” was buried in a private funeral on
Christmas Eve. At the service, Monjack told mourners that the actress was his
best friend and soul mate, sentiments he repeated during the Tuesday
interview.

Monjack, who married Murphy in 2007, said police and coroner’s officials have
not contacted the family to say his wife’s death was from anything other than
natural causes.

Authorities continue to investigate her death but do not suspect foul play.
An autopsy was inconclusive and coroner’s officials are awaiting the results of
toxicology and tissue tests before determining what killed the actress.

Assistant Chief Coroner Ed Winter said Tuesday that he had not seen Murphy‘s
autopsy report, but the condition of her heart would be looked at before her
cause of death is determined.

Sharon Murphy described the wait for answers as torture. “We wish we knew,”
she said.

“She was alive one minute and she was dead the next,” Monjack said.

The pair worked frantically to save Murphy‘s life the morning she died, as
revealed in a heart-wrenching 911 call where Sharon Murphy implores, “Brittany,
please come back!” as Monjack performs CPR.

Sharon Murphy said she has largely ignored tabloid reports that have
suggested her daughter abused drugs or had an eating disorder. She said her
daughter had always been petite and ate often, but burned it off with an active
lifestyle.

Monjack, who has read some of the reports, called them lies based on
anonymous sources who weren’t close to Brittany Murphy or him. He said he is
considering suing some British outlets for “outright fabrications.”

He said the rumors of her drug use were unfounded and had cost his wife roles
in some major films.

He said he is also considering whether to sue the Los Angeles County
Coroner’s Department over an initial report that was obtained by celebrity Web
site TMZ.com, which
listed several prescription medications found in Murphy‘s home. Monjack said
most of the medicines listed in the report were his.

He said his wife took the anti-seizure medication klonopin ever since an
episode she had while filming “8 Mile.” She also occasionally took Sarafem, a
drug aimed at pain and mood swings during menstrual periods, Monjack said.

Klonopin has been cited in several celebrity overdose deaths, but with many
other medications mixed in.

He said he did not think a harmful interaction of drugs played a role in his
wife’s death. She had been sick with flu-like symptoms in the days before her
death and had been taking Robitussin, but nothing more, he said.

Monjack and Sharon Murphy remain in the Hollywood Hills home where Brittany

Murphy collapsed a month ago. They share grief and memories of Murphy, speaking
highly of each other. Monjack calls Murphy his soul mate; Sharon Murphy calls
her daughter “my other half.”

DVDs of some of Brittany Murphy‘s films lay near the entertainment center,
and several framed photographic portraits of the actress that Monjack shot adorn
the walls and other areas of the living room.

“I’m comforted by these photographs,” Monjack said. “I’m comforted by the
transformation from girl to woman that I witnessed.”

The couple planned to display for exhibition some of the
photographs, which can be seen at http://www.simonmonjackphotography.com.

It was just one of the couple’s plans, which included starting a family and
moving to New York. Sharon Murphy said her daughter was talking about having a
child the night before she died. Monjack said they already had baby names picked
out.

Now the pair are planning a public memorial to celebrate Brittany Murphy‘s
life, which will be held in the Los Angeles area at the end of February. Monjack
and Sharon Murphy said they have asked many of the actress’ friends to refrain
from making public comments, but that they expect the memorial will remind
people of her talents and beauty.

Monjack said the memorial will coincide with the launch of the Brittany
Murphy Foundation, a charitable group that he said will support arts education
for children and other causes his wife believed in.

Both Monjack and Sharon Murphy said they expect respect to grow for Brittany
Murphy‘s work and life, once questions about her death are settled. The actress
had completed two unreleased films before her death but their prospects are
uncertain.

Sharon Murphy expressed reluctance about their release because of the
filmmakers’ inexperience, but Monjack said he would approve if the releases were
respectfully done and the profits donated to the Brittany Murphy Foundation.

“I think the dust will settle, the truth will come out,” Monjack said. “I
think people will come to realize the genius of Brittany Murphy and come to
regret the way they treated her while she was alive.”

Posted in Movies on Wednesday, January 20, 2010 9:35 am
Updated: 10:06 am.
| Tags:

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4/07/2001 – Insight Mag – Misleading Medicine

Once again Kelly O’Meara has written an incredible article. This time the
subject is the absurdity of the PMDD diagnosis and the prescribing of Prozac
repacked and renamed as “Sarafem” for that “disorder.” We have included the
first several paragraphs for you and encourage you to go to the Insight
Magazine sight to read the rest.

The article gives much insight into the lengths to which Lilly will go to
cover up the fact that Prozac and Sarafem are one in the same drug.
Apparently as long as they do not admit it publicly it is not reality?

Ann Blake-Tracy, Executive Director,
International Coalition for Drug Awareness
http://insightmag.com/archive/200104301.shtml

InsightMag.com
——————————————————————————
Misleading Medicine
——————————————————————————
By Kelly Patricia OMeara
komeara@…
——————————————————————————

Pharmaceutical giant Eli Lilly is promoting Sarafem as a miracle pill for
women suffering from PMDD, a mental disorder not yet proved to exist.
Whats more, Eli Lilly admits that Sarafem has the same active ingredient as
Prozac, complete with the same dangerous side effects.

Australian-born singer Helen Reddys 1972 hit song I Am Woman has been
called a feminist battle hymn. Many a male disc jockey at the time refused to
air it until the song became part of the soundtrack to a movie and catapulted
to the top of the Billboard charts. Taking a look at the song today, its
hard to imagine the furor generated by the lyrics from the lady down under:
Oh, yes, I am wise, but its wisdom born of pain.
Yes, Ive paid the price, but look how much I gained.
If I have to I can do anything.
I am strong. I am invincible. I am woman.
Nearly three decades since the release of this feminist anthem the
lyrics neither threaten nor offend if they ever did but seem to
acknowledge pride in feminine strength. As if it needed to be said,
historians agree on the significance of women in the building of this nation.
The Jamestown settlement, for instance, was a disaster and on the brink of
failure until women were added to the new colony. The West was won by men and
women working side by side, and the United States triumphed over its enemies
in World War II with the help of nearly 500,000 women in the ranks and
millions more in the factories.
Not surprisingly, women achieved these feats completely unaware that a
few days out of each month they were suffering from a mental disorder. Thats
right. The Food and Drug Administration (FDA) recently approved the use of
Sarafem (fluoxetine) for women suffering from a mental disorder just three or
four days a month in the luteal phase or just before the onset of
menses.
This mental disorder which the American Psychiatric Association
(APA) has not yet accepted, but which is listed in the appendix of the APAs
Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) is called
premenstrual dysphoric disorder, or PMDD. Its a new-and-improved version of
premenstrual syndrome (PMS), which also has not made it to the hit parade of
the official APA list of mental illnesses. The fact that PMDD is listed only
in the diagnostic manuals appendix reflects the APAs desire for further
research before accepting it as a full-fledged mental disorder.
According to the DSM-IV and the FDA, a woman must experience five or
more symptoms before the diagnosis can be made. The unofficial mental
disorder is said to be characterized by the following symptoms:

Markedly depressed mood

Marked anxiety

Marked affectivity

Decreased interest in activities

Feeling sad, hopeless or self-deprecating

Feeling tense, anxious or on edge

Persistent irritability, anger and increased interpersonal conflicts

Feeling fatigued, lethargic or lacking in energy

Marked changes in appetite

A subjective feeling of being overwhelmed or out of control

Physical symptoms such as breast tenderness, swelling or bloating.

Eli Lilly and Co., the Indianapolis-based pharmaceutical company that
makes Sarafem, has been marketing the new treatment with such gusto that
there are jokes about the company exhibiting obsessive-compulsive disorder.
It seems there isnt a magazine to be picked up or a channel to be surfed
that isnt running a Sarafem advertisement.
These ads show women expressing many things. One TV spot depicts a
woman trying to button her slacks and looking angry and agitated. Another
scene shows a woman snapping at her husband, Just leave me alone, while
still another involves a woman slumped on the couch sobbing. Then there is
the slogan: Sarafem More like the woman you are.
Lilly reports in its ads that now, Doctors can treat PMDD with
Sarafem the first and only prescription medication for PMDD. The ad
further states that, Sarafem contains fluoxetine hydrochloride, the same
active ingredient found in Prozac. But both Sarafem and Prozac are
fluoxetine hydrochloride. According to Laura Miller, marketing associate for
Eli Lilly, Fluoxetine hydrochloride is the same active ingredient in Sarafem
as in Prozac. Again and again Insight asked, Then is it the same thing?
Again and again Miller only repeated that the two identical doses of
fluoxetine hydrochloride have the same active ingredient.
Miller refused to acknowledge that Sarafem is just Prozac repackaged,
or that the pill color was changed from green to feminine pink and lavender
to market it for a not-yet-approved mental disorder that never before
existed. The Lilly representative did say the difference in the treatments is
in how women react to the drug.
Never mind that all this dramatic hype, supported by millions of
dollars in marketing, has occurred just before Lilly loses its exclusivity on
Prozac in August. . . . to finish article go to:

http://insightmag.com/archive/200104301.shtml

302 total views, 1 views today

3/13/2001 – March Edition of drugawareness.org now online.

The March edition of the ICFDA www.drugawareness.org site is
now on line. So much has been happening lately, that’s it’s been
difficult to keep up with all the news. But, please take a look
when you can. There are just a sampling of some very important
stories that are posted there.
——-
1/22/01 Doctors and Patients Don’t Talk About Antidepressant
Side Effects
By Carla Cantor, CBS HEALTH WATCH

A new public health survey reveals that nearly half of the people
being treated with antidepressants experience side effects and
55% of those patients stop taking their medication, rather than
talk to their doctors about the issue.

2/19/01 Prescriptions: How your doctor makes the choice
By Joseph P. Shapiro and Stacey Schultz [US NEWS]

Three years ago, doctors at the Everett Clinic in Washington
State took a hard look at the stream of pharmaceutical sales
reps filing into their offices. “Enough!” they said. Then they
closed their doors on the cheery “detailers” who vied for their
attention each day, lugging suitcases of free drug samples.
Medical director Al Fisk, who masterminded the move,
suspected that the samples were skewing his doctors’ drug
choices toward the most heavily promoted drugs–even when
less expensive ones were just as effective. “There’s a reason
why the pharmaceutical business spends [billions] on physician
detailing,” he says. “It’s easy to influence prescribing habits.”

2/24/01 Drug Firms Treat PMS As a Mental Disorder
By TARA PARKER-POPE, THE WALL STREET JOURNAL, As
appeared in The Wall Street Journal, Section B, Front Page

IS SEVERE PMS, or premenstrual syndrome, a mental illness?
Some pharmaceutical companies and psychiatrists are treating
it as one. In new television ads, drug maker Eli Lilly is promoting
the drug Sarafem to treat the problem, now dubbed
Premenstrual Dysphoric Disorder (PMDD). But the pink and
purple pills aren’t a new drug — they are simply repackaged
Prozac, the popular antidepressant.

3/11/01 Paper: Co. Knew of Drug-Liver Link

Warner-Lambert Co. downplayed liver damage concerns as it
sought federal approval for its diabetes drug Rezulin, the Los
Angeles Times reported Sunday.

2/24/01 Paxil Lawsuit

This is our 2nd update (“sitrep” or “situation report”) in our Paxil
withdrawal lawsuit (“Nguyen & Farber v SmithKline Beecham
Corporation”). We filed the case August 18, 2000 against
SmithKline (now “GlaxoSmithKline) in Superior Court, Santa
Clara County, San Jose, California.

2/19/01 Urgent Phenylpropanolamine Recall

Read more about the FDA warning about drugs containing the
ingredient Phenylpropanolamine found in many common over
the counter medications.

3/3/01 US Congressman Dan Burton Requests Immediate
Vaccine Recall

3/5/01 Use of Painkiller Grows Quickly, Along With Widespread
Abuse, By BARRY MEIER and MELODY PETERSEN THE NEW
YORK TIMES

…when the salesman suggested that OxyContin (which is as
potent as morphine) was safe enough to treat short-term pain,
Dr. Leong exploded. “We threw him out of my office,” said Dr.
Leong.

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2/24/2001 – Wall Street Journal Questions PMDD & Sarafem (Prozac)

Here comes the crowd!! Now that Lilly has their approval by the FDA to use
Prozac for PMS (PMDD), all the other makers of SSRIs are racing to get their
drugs approved to get their share of the profits. If this was not such a
horrifying situation with so many dying such terrible deaths everyday, many
more becoming so disabled from these drugs, and so many families being torn
apart from the behavioral reactions, it would almost be funny.

What is most ironic is that the psychologist mentioned at the end of the
article is right. I see women with severe PMS who mix some purified water
with lemon juice and drink a gallon a day for the week before their period
and any sign of PMS leaves. There are so many simple alternative choices for
this that it is amazing that Lilly has convinced so many that they have the
answer in a drug! Even more amazing is that they convinced the FDA – but then
the FDA is always amazing me with what they allow the public to be exposed to
as “safe”!

Ann Blake-Tracy, Executive Director,
International Coalition for Drug Awareness
www.drugawareness.org
_________________________

Wall Street Journal, Section B, Front Page

February 23, 2001, Health Journal

Drug Firms Treat PMS As a Mental Disorder

By TARA PARKER-POPE
Staff Reporter of THE WALL STREET JOURNAL

IS SEVERE PMS, or premenstrual syndrome, a mental illness? Some
pharmaceutical companies and psychiatrists are treating it as one. In new
television ads, drug maker Eli Lilly is promoting the drug Sarafem to treat
the
problem, now dubbed Premenstrual Dysphoric Disorder (PMDD). But the
pink and purple pills aren’t a new drug — they are simply repackaged
Prozac,
the popular antidepressant.

Makers of similar antidepressants, known as serotonin reuptake inhibitors,
or
SSRIs, also may follow suit. In January, Pfizer asked the FDA to approve
Zoloft to treat PMDD. Forest Laboratories’ Celexa and GlaxoSmithKline’s
Paxil also have been studied.

The medical community, however, remains divided about whether PMDD is a
real disorder or simply a way for drug companies to cast a wider net in
search
of new customers. Critics are particularly concerned about labeling women
as
mentally ill because of problems associated with menstrual cycles.

“When you start calling what PMS is a psychiatric disorder, what are you
saying about the women of this world?” says Nada Stotland, director of
psychiatric education at the Advocate Illinois Masonic Medical Center in
Chicago. “This lends itself to prejudices people already have about women
being moody and unreliable.”

ALTHOUGH THE FDA has approved Sarafem to treat PMDD, the
psychiatric community is still debating the legitimacy of the disorder. The
American Psychiatric Association includes PMDD in the appendix of its
current
Diagnostic and Statistical Manual of Mental Disorders, the part of the
manual
reserved for issues needing further research before being officially
accepted as a mental illness.

Fueling skepticism about PMDD and Sarafem is the
fact that in August, Lilly, based in Indianapolis, loses
patent protection on Prozac, a drug with $2.6 billion
in sales last year, according to IMS Health. With
Sarafem, the firm now has a separate patent to use
the drug for PMDD through 2007, allowing it to
partially offset losses in sales as rivals produce
generic Prozac.

Repacking prescription drugs for other uses is
becoming more common. Glaxo, for example, has
repackaged its antidepressant Wellbutrin as the
stop-smoking aid Zyban.

Many physicians argue that PMDD is a legitimate mental illness triggered by
normal hormonal fluctuations in a woman’s menstrual cycle. About 3% to 5%
of
menstruating women are affected. “This is a subset of women who have
really,
really severe mood changes and changes in their behavior,” says Jean
Endicott,
professor of clinical psychology at Columbia University’s College of
Physicians
and Surgeons. “It can be very debilitating.”

Unlike other mental illnesses that affect a patient on a daily basis, PMDD
is said
to affect women during the week to two weeks before their period. The
symptoms include depression, anxiety, tension, anger, irritability and the
feeling
of being overwhelmed or out of control. Other symptoms also are typical of
traditional PMS, such as breast tenderness, headache, bloating and weight
gain.

In order to be diagnosed with PMDD, a patient must have at least five
symptoms, including one involving mood change, and be markedly impaired as
a result. Patients should track symptoms for two months before a diagnosis
is
made.

About 60% of women who take Sarafem for PMDD will be helped, according
to Dr. Endicott. Currently, the drug is taken every day, but researchers
are
studying dosing that would reduce the pills to several days a month,
limiting side
effects, which can include tiredness, upset stomach, nervousness, dizziness
and
difficulty concentrating.

A 38-YEAR-OLD Chicago flight attendant named Betsy, who didn’t want her
full name used, says the week before her period she felt like an
“over-wound
spring, getting wound tighter and tighter,” and would often scream and lose
control. “That’s not my normal disposition,” she says. “I knew something
wasn’t
right.”

She noticed the correlation with her menstrual cycle and discussed her
problems with her gynecologist, who prescribed Sarafem. “It has completely
taken away the symptoms,” she says.

Dr. Stotland and other critics, however, worry that eager patients may push
to
be prescribed Sarafem as a quick fix, preventing doctors from diagnosing
other
serious health problems. Dr. Stotland says research has shown that more
than
half of the women who believe they have severe PMS actually suffer from
other
problems, such as depression, panic disorder or even domestic violence.

Lilly’s marketing of Sarafem also has sparked controversy. The first ads
showed a frustrated woman wrestling with a shopping cart. “Think it’s PMS?
It
could be PMDD,” the ads said. But the FDA said the ads trivialized the
seriousness of PMDD, and the campaign was pulled. New ads show one
woman arguing with her husband and another frustrated because she can’t
button her pants.

Lilly spokeswoman Laura Miller says the ads attempt to show the full gamut
of
PMDD symptoms. “It’s up to the doctor and the woman to determine whether
she has PMDD and whether treatment is appropriate,” she says.

But Paula Caplan, a psychologist and affiliated scholar at Brown
University’s
Pembroke Center for Research and Teaching on Women, says instead of
labeling women as mentally ill, physicians should urge diet changes,
exercise,
less caffeine and even calcium supplements. “But nobody makes much money
off calcium tablets,” she adds.

E-mail comments to Tara Parker-Pope at healthjournal@…

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12/29/2000 – Sarafem Nation – Renamed Prozac Targets Huge Market: Premenstrual W

http://www.villagevoice.com/issues/0049/spartos.shtml

Published December 6 – 12, 2000

Renamed Prozac Targets Huge Market: Premenstrual Women

Sarafem Nation

by Carla Spartos

A visibly irritated woman yanks on a supermarket shopping cart that’s stuck
in its stack while a soothing female voice-over recites a litany of PMS
symptoms. She asks, “Think it’s PMS? Think again. . . . It could be PMDD.”

Premenstrual Dysphoric Disorder, or PMDD, is a fresh-minted mental illness
that purportedly affects 3 to 10 percent of all menstruating women. Mood
symptoms like depression, anxiety, anger, irritability, or sensitivity to
rejection are said to be so severe the week before a woman’s period that it
impairs her functioning. According to Dr. Jean Endicott, professor of
clinical psychology at Columbia University’s College of Physicians and
Surgeons, “What’s ordinarily irritating becomes enraging.”

To be diagnosed with PMDD, women must keep a daily diary of their symptoms
for the duration of two menstrual cycles. The symptoms must kick in after
ovulation and disappear once menstruation begins. “The timing is exquisite,”
remarks Endicott.

The timing is also exquisite for Eli Lilly and Company to make a financial
killing off of PMDD. Next year, the drug company will lose its patents on the
antidepressant Prozac, and with them its monopoly on the market. To ward off
declining profits, Lilly has found another use for its wonder drug—treating
PMDD.

In July, Lilly got Food and Drug Administration approval to market Prozac
under the new name Sarafem. The company is packaging the drug in pretty pink
and lavender capsules, exclusively for women, most in their late twenties or
early thirties. Says Laura Miller, a spokesperson for Lilly, “Women told us
they wanted treatment that would differentiate PMDD from depression.”

According to Endicott, the symptoms of PMDD primarily interrupt
“interpersonal relationships”—basically, those involving spouses, children,
and coworkers. In one group of women with self-described premenstrual
symptoms, researchers found no increase in absenteeism or decline in work
performance, although the women themselves perceived that to be the case.

“PMDD is unique because there is virtually no other disease that people
insist upon having,” says Dr. Nada Stotland, chair of psychiatry at Illinois
Masonic Medical Center. According to Stotland, the majority of women who go
to PMS clinics have symptoms that aren’t in fact related to their periods.
“Most are depressed everyday. Others have anxiety and personality disorders.
Some are in psychological pain because they are being abused.”

That women might seek help on the pretense their problems are hormonally
based makes PMDD more slippery to recognize and study. Stotland says she’s
particularly concerned that Lilly is targeting almost exclusively OB-GYNs as
Sarafem prescribers, which puts gynecologists in the position of treating
mental illness. She says Lilly’s advertising campaign may convince enough
women they need Sarafem, leading them to pressure their doctors to skip the
two months needed for diagnosis and instead send them straight to the
pharmacy. And since Sarafem will also work for those with chronic depression,
a misdiagnosis can go undetected.

Proponents of Sarafem downplay the potential for misuse. “I doubt that a lot
of people who don’t need the treatment would get it,” argues Endicott.
“First, it’s a prescription drug. Second, women are not big pill poppers.”
Sherry Marts, scientific director of the Society for Women’s Health
Research—a nonprofit organization that promotes research in women’s health
issues—concurs. “This is a real medical condition that requires treatment for
a small percentage of women,” she says.”Not, ‘I’m a little bloated, I’m gonna
pop some Prozac.’ ”

But critics claim that 3 to 10 percent of all menstruating women is no small
number. “That’s a minimum of half a million North American women suffering
from PMDD,” says Paula Caplan, a psychologist and affiliated scholar at Brown
University’s Pembroke Center for Research and Teaching on Women.

Whether PMDD is a real condition is still subject to debate. Although both
sides agree that a certain subset of women may be sensitive to normal
hormonal changes, that’s about all they agree on. The question remains, if
women sometimes snap at their husbands if they don’t pick up after
themselves, or at their kids if they do poorly in school, should they be
branded with a mental disorder? “Women are commonly in situations defined by
stress—responsibility without authority,” says Stotland. ‘That’s almost the
definition of a typical woman’s job.”

Some doctors fear that women who have legitimate reasons to be unhappy will
be silenced by the PMDD diagnosis, and that Sarafem could prove to be the
Valium of the naughts. “Ordinary, healthy changes in mood and emotion are
being pathologized when they happen to women, and since women believe they
shouldn’t feel irritable, angry, or depressed, they are quick to blame
themselves,” says Caplan. For men, “There’s no testosterone-based aggressive
disorder.”

Endicott disagrees. “If men had PMDD, it would have been studied a long time
ago.”

But would it? “To say that a huge proportion of the female population is
disabled represents a potentially horrendous setback for women in the
workplace,” says Stotland. She points to the woman who finally speaks up to
her boss and in return is asked, “Oh, is it that time of the month?” Agreeing
to that kind of put-down might save the woman her job. PMDD could reinforce
the stereotype of the hysterical woman not only to employers, but to women
themselves.

Caplan says that a diagnosis of PMDD will have far-reaching legal
implications as well. Might women who’ve been labeled as mentally ill be
deprived of the right to make their own decisions? Might they lose custody of
their children in divorce cases? In other words, will PMDD sufferers be seen
as the biological equivalent of Dr. Jekyll and Mr. Hyde?

That’s already the most common complaint of PMDD sufferers, says Endicott,
who reports women saying over and over, “This isn’t me.” Lilly promotional
literature echoes this sentiment. “The good news is there is treatment
available that can help you feel more like the woman you are every day of the
month,” the brochures say. But who is this woman? And why are we so concerned
with her hormones?

——————————————————————————

One thing is for sure: Eli Lilly and Company has a financial stake in PMDD.
Lilly’s Prozac patents are expiring in 2001 and 2003. This means the market
will open up to cheaper generic competitors. Analysts have estimated that
Prozac sales will decline drastically—from about $2.51 billion in 2000 to
$625 million in 2003. Sarafem will provide a significant new market—women—to
boost profits. That’s a smart move, since women are the primary users of
drugs that alter mood. And, according to documents posted on the FDA’s Web
site, Lilly has proposed a “pilot study of PMDD in adolescents to estimate
its response to treatment with fluoxetine.” Fluoxetine, by the way, is the
generic name for Sarafem (and Prozac).

Another plus for Lilly is that creating a new and separate trademark for
Prozac lessens the stigma associated with antidepressants, and lets the
company dodge some recent bad press, from the publication of Harvard’s Joseph
Glenmullen’s Prozac Backlash to a new study in Brain Research that suggests
the antidepressant may cut off axons of the nerves they target—in effect
causing brain damage.

By 2004, Sarafem sales are expected to climb to $250 million a year,
according to Bear Stearn’s Bottle Report. Lilly would not divulge projected
sales nor the amount of money spent marketing, researching, and developing
Sarafem, but their financial report shows a lot of zeroes. For the first
three quarters of this year, the corporation spent close to $2.3 billion in
marketing and administrative costs, much more than its research and
development, which totalled about $1.5 billion.

But most extraordinary is that the federal government is convinced of the
existence of PMDD, while the psychiatric community isn’t so sure at all. PMDD
is currently listed in the appendix of the DSM-IV—the psychiatrist’s bible of
mental illnesses—as “needing further study.”

The controversy began in 1987, when the compendium first included specific
criteria for Late Luteal Phase Dysphoric Disorder—the former name for
PMDD—in its appendix as a “proposed diagnostic category” needing more
research. In 1993, as the American Psychiatric Association’s task force was
compiling the fourth edition of the manual, the category was revisited.
Should it remain in the appendix, get moved to the body as a recognized
diagnostic category, or be removed altogether?

The committee decided to keep PMDD in the appendix. According to Psychiatric
News, the APA’s professional newsletter, “Members of the task force agreed
there were a number of problems with methodology within the PMDD literature.
The problems included unclear definitions, small sample sizes, lack of
control groups, lack of prospective daily ratings of symptoms, no
documentation of the timing and duration of symptoms, and failure to collect
appropriate hormonal samples.” However, the committee suggested specific
criteria for diagnosing PMDD, including specs for symptoms and timing.

Five years later, the fate of PMDD was still unclear. In October 1998, the
Society for Women’s Health Research organized a discussion, headed by
Endicott, to answer this question: “Is premenstrual dysphoric disorder a
distinct clinical entity?” Once again, experts reviewed the PMDD literature,
this time in the company of FDA and Lilly representatives.

Dr. Sally Severino, a now retired professor of psychiatry at the University
of New Mexico, reiterated flaws in the research. First, just because women
can be identified by PMDD criteria “is not proof that PMDD exists as a valid
diagnosis.” Second, although cross-cultural studies identified physical
complaints related to menstruation, mood symptoms like anger and irritability
were not found worldwide to the same degree as in America. Severino argued
that if PMDD can’t be identified in other populations, then “consideration
must be given to the criticism that PMDD is a culturally bound syndrome or an
unnecessary pathologizing of cyclical changes in women.”

Ignoring these objections, the round table concluded that PMDD was a
“distinct entity with clinical and biologic profiles dissimilar to those seen
in other disorders.” In other words, a mental illness.

What changed between 1993 and 1998? For one thing, Lilly funded a 1995 study
that showed Prozac was effective in treating PMDD. Published in The New
England Journal of Medicine, the study had a large sample size, and was
placebo-controlled and double-blind (meaning neither the doctor nor the
participant knows who’s getting drugs or a sugar pill)—all the makings of a
pristine scientific inquiry. A slate of studies followed suit, all with the
same results: About 60 percent of women diagnosed with PMDD respond to
Prozac.

Yet one 1998 study discussed by Endicott’s roundtable found that 55 percent
of women diagnosed with premenstrual symptoms got significant relief from
increased calcium intake. The group went on to comment that “the area of
calcium is not well explored.” That leads critics to wonder why other
treatment options are getting the cold shoulder. “Why not spend pages and
pages pushing calcium?” asks Caplan, who served on the 1993 DSM committee.
And although there is evidence that people with PMDD can feel better with
only intermittent doses of Prozac—and suffer fewer side effects like sexual
dysfunction—the studies Lilly presented to the FDA looked solely at the
effectiveness of daily doses, or roughly double the amount some researchers
say is needed.

According to Caplan, almost all of the data the roundtable evaluated fell
into two categories: the old problematic studies available to the DSM-IV
group or the new research into using Prozac to treat PMDD. “There was nothing
that looked at the validity of the PMDD construct,” says Caplan.

Did Lilly railroad Sarafem through? Two members of the 16-person roundtable
conducted PMDD research funded by Lilly, and another member has received
honoraria as a speaker for Lilly. Endicott, who hasn’t received research
funds or speaking fees from Lilly, opened the company’s November 1999
presentation to an FDA advisory committee, which voted unanimously in favor
of the new PMDD indication for Prozac. In addition, the Society for Women’s
Health Research trumpets on its Web site an “unrestricted educational grant
from Eli Lilly and Company,” which they’ve used to promote PMDD awareness,
including a national survey conducted in November to gauge women’s awareness
of PMDD and available treatment (i.e., Sarafem). “Lilly had done an
extraordinary job of getting this to the public,” says Stotland.

Researchers taking a ride on the drug-company gravy train is not unique to
those who studied PMDD, but it can have effects on scientific research. “I
don’t think people falsify results. But what kinds of questions do you ask?
Which results do you publish?” asks Stotland. “When I was a resident it was
the departments who had money to bring in speakers. Now, it’s the drug
companies who are flying people around.”

Incidently, at the time of the interview, Stotland was attending a PMDD
conference held at a Palm Springs resort, courtesy of Eli Lilly.

Tell us what you think. editor@…

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7/24/2000 – Prozac [Sarafem] and PMS – What’s in a name?

Once again we thank Vera Hassner Sharav, President, CIRCARE: Citizens for
Responsible Care & Research, a Human Rights organization, for passing on this
interesting commentary on Prozac’s name being changed to Sarafem for PMS. The
dangers of interaction leading to serotonin syndrome – a life threatening
complication of serotonergic medications – is most obvious in all of these
name changes.

Ann Blake-Tracy

~~~~~~~~~~~~~~

http://mentalhealth.about.com/health/mentalhealth/library/weekly/aa071700a.htm

Prozac and PMS – What’s in a name?
Leonard Holmes, Ph.D.

Drug companies are doing some interesting things to the names of their
products. The FDA recently approved the chemical fluoxetine for the treatment
of symptoms related to PMS – Premenstrual Syndrome (officially known as PMDD
– pre-menstrual dysphoric disorder). Fluoxetine is sold by Eli Lilly and
Company under the name Prozac. Will women with PMS be taking prescriptions
for Prozac to their pharmacist? Not likely. Lilly has decided to rename the
drug Sarafem when it is prescribed for this problem. Why the new name?
Lilly’s official position follows:

The additional trademark will help with educational efforts for this largely
underrecognized disorder while reducing confusion about the differences
between depression and PMDD. (Lilly Newsroom 7/00)

What about the confusion that is added by two different names for the same
chemical? What happens when a patient gets Prozac from one doctor and
Sarafem from another?

Prozac has a mixed reputation. While some have hailed it as the first in a
class of wonder drugs others have implicated it it in some cases of suicidal
behavior. There have never been any substantiated cases of suicidal behavior
traced to Prozac or any other antidepressant. Lilly has a response to these
rumors too:

Concerning media allegations of Prozac and suicide there is no credible
evidence that establishes a causal link between Prozac and violent or
suicidal behavior. In fact, in September 1991, a panel of experts appointed
by the FDA found no credible evidence of a causal link between the use of
antidepressant drugs, including Prozac, and suicidal or violent behavior.
(Lilly Newsroom quoted 7/00)

This is not the first time that a drug company has given a new name to the
same medication. In 1997 bupropion was approved for smoking cessation. This
medication, better known by the trade name Wellbutrin was re-christened Zyban
when used for smoking cessation. That’s why the Zyban ads warn you not to
take it if you are taking Wellbutrin. Not much fuss was made about this at
the time, but it seems to have started a trend.

Steve Cartun, M.D. did write to protest the renaming back in 1997. His logic
still rings true, and there is a great deal of irony in the example that he
used at the time. An excerpt:

New indications for old medications have become a staple of
psychopharmocology. Prozac, for example, originally introduced as an
antidepressant, has since garnered FDA approval for the treatment of
obsessive-compulsive disorder. Eli-Lilly, the company that manufactures and
holds the patent for Prozac, did not rename it’s product simply because it
had earned a new indication. Even though Prozac had been subjected to false
and damaging statements, Eli-Lilly chose not to fashion it in newer clothes.
The renaming of Wellbutrin by the same company that manufactures it, simply
because research studies show that it has a new and valuable use, gravely
concerns me….

The renaming of medications is a dangerous semantic. While a pharmaceutical
company can argue that a new name that gains wider use will ultimately help
the patient, I believe that such a measure treats physicians like naive
consumers who care more about a logo than the gritty science that logo
represents. Perhaps this is an alarming symptom of how trivialized the
importance of reality, at the expense of marketing, is becoming. Physicians
have already been renamed health care providers. Wellbutrin is now being
named Zyban for a new use. An industry insider once told me that the letter
“Z” is particularly useful for gaining audience attention. I hope that Zyban
gains all the attention it can to prevent this naming process from becoming a
trend. Enough misrepresentation. Convolution must be resisted. If it
continues, the meaning of health care will become even more lost than it is
now. (Cartun, 1997)

I’m afraid that Dr. Cartun’s hopes have not been realized. Lilly has renamed
Prozac to appeal to women with PMS who might otherwise shy away from the
medication. It’s hard enough to keep track of all of the different
medications out there. We shouldn’t have to keep track of multiple trade
names for the same medication from the same company.

Excerpt from a 1997 letter by Dr. Steve Cartun:

New indications for old medications have become a staple of
psychopharmocology. Prozac, for example, originally introduced as an
antidepressant, has since garnered FDA approval for the treatment of
obsessive-compulsive disorder. Eli-Lilly, the company that manufactures and
holds the patent for Prozac, did not rename it’s product simply because it
had earned a new indication. Even though Prozac had been subjected to false
and damaging statements, Eli-Lilly chose not to fashion it in newer clothes.
The renaming of Wellbutrin by the same company that manufactures it, simply
because research studies show that it has a new and valuable use, gravely
concerns me….

The renaming of medications is a dangerous semantic. While a pharmaceutical
company can argue that a new name that gains wider use will ultimately help
the patient, I believe that such a measure treats physicians like naive
consumers who care more about a logo than the gritty science that logo
represents. Perhaps this is an alarming symptom of how trivialized the
importance of reality, at the expense of marketing, is becoming. Physicians
have already been renamed health care providers. Wellbutrin is now being
named Zyban for a new use. An industry insider once told me that the letter
“Z” is particularly useful for gaining audience attention. I hope that Zyban
gains all the attention it can to prevent this naming process from becoming a
trend. Enough misrepresentation. Convolution must be resisted. If it
continues, the meaning of health care will become even more lost than it is
now. (Cartun, 1997)

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7/7/2000 – FDA Boosts PMS Insanity

Sarafem, what a nice sounding name for such a deadly drug. How many patients
will know that they are really getting Prozac with a different name? Why is a
name change necessary? If it said Prozac on the label, would the patient take
it? We will not know with the FDA allowing Lilly to change Prozac’s name when
being prescribed for this disorder. Giving these SSRIs different brand names
does nothing to change the dangers of these drugs, but much to confuse the
patient about the dangers and just what drug they are really getting. Talk
about “failure to warn”!

For some time now doctors have given SSRI antidepressants for PMS. They have
encouraged patients to take the drugs in the most dangerous manner I am aware
of – taking them for a week or so and dropping “cold turkey,” then doing the
same the following month! Well, if we thought we saw rage before with PMS,
just wait! Now we can see SSRI withdrawal rage every month rather than the
PMS. At least we will see a change in the time it occurs and the intensity,
right? And now we can, with the FDA’s approval, cure PMDD with drug-induced
psychosis, suicide or murder/suicide. What a novel idea!

Sorry about the sarcasm. I guess I have seen too many people die or have
their lives destroyed as a result of using serotonergic drugs. Just how much
longer can these terrible heart rending tragedies be the “acceptable” risk in
anothers’ feeling better due to a drug-induced hase for things like PMS or
shyness? Please someone tell me where the “acceptable” risk is in using these
powerful and very dangerous drugs for such minor health problems when there
are so many simple and harmless natural solutions like Omega 3 oils? It
couldn’t be because those harmless solutions don’t make anywhere near the $30
– $40 million per day that these drugs bring in, could it? It is clear whose
interest the FDA has in mind with this approval.

Ann Blake-Tracy
_________________

FDA APPROVES FLUOXETINE TO TREAT PREMENSTRUAL DYSPHORIC DISORDER

FDA has approved fluoxetine (Sarafem) as the first drug treatment for
Premenstrual Dysphoric Disorder(PMDD), a disorder that causes mood changes
and physical symptoms such as bloating and breast tenderness in women.
Fluoxetine was approved as Prozac in December l987 for treating depression,
and has also been approved for treating obsessive compulsive disorder and
bulimia. The following may be used to respond to questions.

On November 3, 1999, FDA’s Psychopharmacologic Advisory Committee unanimously
recommended approval for fluoxetine to treat women with PMDD. The committee
concluded that fluoxetine was effective for the condition and that PMDD has
well defined, accepted diagnostic criteria. The committee also advised that
the drug should be used only to treat women whose symptoms are severe enough
to interfere with functioning at work or school, or with social activities
and relationships.

According to the American Psychiatric Association Diagnostic and Statistical
Manual (DSM-IV), a diagnosis of PMDD requires that patients experience at
least five of the symptoms that characterize PMDD. PMDD has both affective
(mood) and physical symptoms, and is characterized by depressed mood,
anxiety, tension, affective lability (a tendency to alternate between
cheerful and somber moods), and persistent anger or irritability. Other
features include decreased interest in activities, difficulty concentrating,
lack of energy, change in appetite, headache, joint and muscle pain. The mood
symptoms often cause disturbances in social relationships. Physical symptoms
include weight gain, bloating, and breast tenderness. To support a diagnosis
of PMDD, the symptoms must occur regularly in the luteal phase of a woman’s
cycle, and disappear after onset of menstruation. (The luteal phase
corresponds to the period between ovulation and onset of menstruation.)

Fluoxetine’s effectiveness for the treatment of PMDD was established in two
double-blind placebo-controlled trials. In the first study, 320 patients were
given fluoxetine continuously throughout the menstrual cycle. This study
showed that the drug was significantly more effective than placebo by
measurements of changes in mood and physical symptoms of PMDD. In a second
study, 19 patients were treated with fluoxetine and placebo continuously
throughout the menstrual cycle for a period of three months each. In this
study, fluoxetine was significantly more effective than placebo on a scale
measuring changes in mood, physical and social impairment symptoms.

Sarafem will be marketed by Eli Lilly, of Indianapolis, Ind., with a patient
information brochure and physician labeling specific for the drug’s use. The
drug was not studied in women who were taking oral contraceptives. Common
side effects were similar to those experienced by other fluoxetine users and
included nausea, tiredness, nervousness, dizziness and difficulty
concentrating.

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