Pregnant on SSRIs

“My son, Taylor, was born weighing much less than any of my previous seven children and displaying an irritability I had never experienced.”

To the FDA Advisory Panel on Antidepressant Safety in Children,

My name is Sylvia Olsen and I am the mother of eight children from Salt Lake City, Utah. I suffered for many years with clinical depression and in 1988 my psychiatrist put me on an SSRI medication. I was told that, because it was clinical depression, I would need to take it for the rest of my life. Subsequently, when I got pregnant with my eighth child in 1991, I asked if I could keep taking the medication. My doctor said there was no evidence of negative side effects, and since I was already on it, I just kept taking it. Looking back, I believe the medication produced an overriding feeling of “everything is fine” which clouded my judgment. Normally, I would think twice before even taking an aspirin when I was pregnant. After all, we are talking about the development of a human being.

My son, Taylor, was born weighing much less than any of my previous seven children and displaying an irritability I had never experienced. I soon noticed his body was tense all the time and his movements stiff. The slightest sound would startle him to the point of screaming and, often, even as he slept, his arms would be held stiff and straight up from his body. Although I’ve had no experience personally taking care of “crack babies”, as they used to call them, I kept thinking how he reminded me of things I had heard about them. He would cry continually and seemed to find great comfort in being wrapped very snugly in a blanket and held very tightly.

As Taylor grew, we also had to deal with episodes of unreasonable displays of anger. When he got upset about something as simple as his shoe tied wrong, it was as though he had no ability to reason. He would scream, kick, and flail completely out of control. We would have to put our arms around him to restrain him from hurting himself or trashing his room and sit there for as long as half an hour before he would start to gain control of himself and stop screaming and gnashing. Then, everything would be fine as if nothing had happened. Other than this, and some allergies and skin problems, things appeared normal until he started school.

Although, he seemed to be bright and aware at home, in school he struggled with reading, writing, spelling and math, unlike his older brothers and sisters. Even though his tantrums are almost non existent now,(we believe through the help of nutritional supplements) and his academics have improved a lot, he has always required remedial help. One thing that always comes up when talking to school aids who have worked with Taylor, particularly, one-on-one, is that they are puzzled by one thing in his learning process. He will appear to understand something perfectly, a math process for instance, and even be doing it on his own for a while, when suddenly, in the middle of the same work, it’s as though a light bulb goes off and he has no knowledge of even being taught the process. Then, later, he knows how to do the problem again as if he never lost it! They say it appears to be some odd kind of glitch in his brain, and I believe it is just another symptom of the developmental problems due to the SSRIs I was taking when pregnant with Taylor.

I believe there are safe and affective ways of dealing with clinical depression in children other than the use of SSRIs and that the benefits do not outweigh the risks and unknown side effects.

Antidepressants do not actually heal the human mind. If they did, then we would see a decline in depression across our nation, but we do not. Please look at the possibility that there is another way to treat this growing problem that, I believe, SSRIs only mask. Even John March, chief of child psychiatry at Duke University, who receives grants from Lilly and research funds from Pfizer, said, “These medicines are not a panacea, and will not, on average, carry kids to remission.”

After eight years on these medications, I once spent a several months trying to cut back by just a few milligrams and suffered terrible bouts of depression from the withdrawal. Yet, later, through the help of a nutritionist, I was able to wean off of them completely in just a three month period. That was seven years ago and I have not suffered from depression since.

Sincerely,

Sylvia Olsen
574 Latonia Circle
St. George, UT 84790
(435)688-7915

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5/01/2001 – World Health Organization – SSRI Addiction

“A league table of withdrawal and dependency side-effects, published by the
WHO, shows that drugs including Prozac and Seroxat [Paxil] have produced far
more complaints from patients than old-fashioned tranquillisers . . . SSRIs
(selective serotonin reuptake inhibitors), including Prozac, are more
addictive than tranquillisers such as Valium.”

Yesterday, in several major newspapers Lilly placed full page ads offering a
coupon for a month of free Prozac. Do you think they warned the consumer in
those ads that these free pills were addictive? Because so few doctors are
aware of this withdrawal and do not know how to withdraw patients from SSRIs,
after the month on the “free” pills the patient would have to continue to
purchase the drug until they could find my tape on how to get off Prozac
safely.

If you had told me ten years ago, shortly after I began researching the SSRIs
and dealing with patients going through horrific withdrawal from Prozac, that
it would take TEN years for the World Health Organization to finally see what
I was seeing, I would not have believed it. It was so obvious! But I have
waited and waited and waited as I have warned and warned and warned of this
addiction and withdrawal and finally today we see the WHO admit it.

At least the WHO have warned the public now, but where is the FDA? Will they
finally at least admit this much about SSRIs? All of these organizations that
society thinks are there to protect them – where were they as millions
suffered needlessly? How many times do we need to see this repeated with one
drug after another before we realize that there is no protection to the
consumer via these agencies? Obviously “buyer beware” most definitely applies
in this arena of prescription drug use. This is why I feel it is so important
to educate the public about these drugs.

You can mark my words when I say that this is only one of MANY more
admissions that will continue to come confirming all the warnings that I gave
in my book about the SSRI antidepressants, Prozac: Panacea or Pandora?

Ann Blake-Tracy, Executive Director,
International Coalition For Drug Awareness
www.drugawareness.org and author of
Prozac: Panacea or Pandora? ()

http://news.independent.co.uk/uk/health/story.jsp?story=69366

01 May 2001
Home > News > UK > Health

World health watchdog warns of addiction risk for Prozac users

By Robert Mendick

29 April 2001

Prozac, billed for years as a harmless wonder drug, often creates more
problems than the depression it is supposed to be treating, warns the head of
the World Health Organisation’s unit monitoring drug side-effects.

Professor Ralph Edwards says Prozac and drugs similar to it are
overprescribed. A league table of withdrawal and dependency side-effects,
published by the WHO, shows that drugs including Prozac and Seroxat [Paxil]
have produced far more complaints from patients than old-fashioned
tranquillisers prescribed by doctors in the 1970s. Campaigners say this
proves that the drugs called SSRIs (selective serotonin reuptake inhibitors),
including Prozac, are more addictive than tranquillisers such as Valium.

“SSRIs are probably over-used,” says Professor Edwards. “They are used for
relatively minor psychiatric problems, and the issue of dependence and
withdrawal has become much more serious. You risk creating a greater problem.
For serious psychiatric problems, it is worth the risk. But if you are just
tired or going through a bad patch, well, people get over that without
medication.”

A spokeswoman for Eli Lilly, makers of Prozac, accepted there are potential
side-effects including head-aches, dizziness, sleeplessness and nausea but
added: “The benefits of Prozac far outweigh the downsides. Extensive
scientific and medical experience has demonstrated that Prozac is a safe,
effective antidepressant that is well-tolerated by most patients.”

Prozac has been taken by an estimated 35 million people worldwide since its
launch a decade ago. But the reputation of SSRIs as wonder drugs is being
questioned. Research by Dr David Healy, at the University of Wales, appeared
to show that two people in a trial group of 20 became violent after taking an
SSRI.

Dr Healy’s research may be presented as evidence in a High Court case being
brought by the family of Reginald Payne, a retired teacher who was taking
Prozac when he killed his wife then jumped off a cliff. The family is suing
Eli Lilly, claiming negligence and saying the pharmaceutical firm failed to
warn Mr Payne of side-effects, which they say include suicidal and violent
behaviour.

The experiences of Ramo Kabbani on Prozac prompted her to set up the Prozac
Survivors Support Group. In two years, it has taken 2,000 calls. Ms Kabbani
claims SSRI withdrawal causes side-effects ranging from flu-like symptoms
such as dizziness and aching muscles to suicidal tendencies. She began taking
Prozac to combat depression after the death of her 27-year-old fiance from a
heart attack.

“The medication stopped me working through the feelings of grief which had
caused the depression.” she says. “When I came off Prozac I became
super-sensitive and very emotional. I found it worse going through withdrawal
than going through the depression.”

Council for Involuntary Tranquilliser Addiction 0151 949 0102; Prozac
Survivors Support Group 0161 682 3296.

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4/18/2001 – Paxil Is Approved for Anxiety Disorder?!

Incredible! The FDA continues to undermine the health and safety of America
with this latest approval – as if doctors had ever noticed that Paxil was NOT
approved for anxiety before this. They have been handing it out like candy
for any and everything they can think of for years.

What is so disconcerting about this is that anxiety can be caused by two
disorders in particular – low blood sugar (hypoglycemia) or seizure activity.
Paxil can trigger both hypoglycemia and seizures. So, if a doctor does not
check to see if the patient is suffering from either of those disorders (and
that is hard to do in the three minutes it has been reported that it usually
takes for a doctor to recommend one of these SSRIs), the Paxil could throw
the patient into serious blood sugar problems or seizures.

Did the FDA consider any of that information before this approval?
Considering the number of drugs pulled from the market in the last few years,
chances are slim that they did.

So now many more ethical doctors who were not handing out Paxil for anxiety
before will feel that with the FDA’s approval they can do so without worry.
No one has warned them that the patient will be lucky to live through the
horrific withdrawal though. As Dr. Nancy Snyderman pointed out in the 20/20
special last August, it may take patients up to a year to get off this drug
safely. (Something I have been saying for years.)

Once again we have the FDA to thank. Isn’t it long past time for them to be
sued for the lives being lost to their incompetence? I guess I just see too
many families wiped out in murder/suicides and too many mothers killing their
children and too many school shootings and workplace violence incidences
induced by Paxil to be patient any longer about this.

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

http://www.nytimes.com/2001/04/17/business/17GLAX.html?searchpv=nytToday

April 17, 2001

Paxil Is Approved for Anxiety Disorder

By BLOOMBERG NEWS

WASHINGTON, April 16 (Bloomberg News) — Glaxo- SmithKline P.L.C. has won the
Food and Drug Administration’s approval to market its antidepressant Paxil
for treating general anxiety disorder, a new use for the drug.

That makes Paxil the first drug in its class to be approved for the
condition, which affects about 10 million Americans and involves excessive,
often debilitating worrying, the company said today.

“Generalized anxiety disorder can paralyze sufferers with uncontrollable
worry, devastating people’s lives,” said Jack Gorman, a professor in the
department of psychiatry at Columbia University. “Paxil provides a new
alternative to help sufferers regain control over their lives.”

Paxil is already approved for treating depression, obsessive- compulsive
disorder, social phobia and panic disorder. With sales of $2.4 billion, Paxil
was the world’s seventh top-selling drug in 2000, according to figures
compiled by the prescription drug tracker IMS Health Inc.

New indications are important to the company’s efforts to defend Paxil, which
belongs to same class as Eli Lilly’s Prozac, against generic competitors.

In a different class of medicines, two antidepressants, Effexor from American
Home Products and Buspar from Bristol-Myers Squibb, are also approved to
treat general anxiety disorder.

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4/15/2001 – Prozac critic sees U of T job revoked

This article makes it very clear what unethical tactics Lilly and other
pharmaceutical companies use regularly. With Lilly being the major
contributor to this university it should be obvious who pulls the strings in
this situation.

Who is pulling the strings at your alma mater? Drug companies have tied up
about every university in this country and around the world to gain control
over the disinformation coming out of those universities in the form of
“medical studies.” Yes, those same studies we just learned are being
“ghostwritten” by pharmaceutical companies and then pawned off to the public
as the “gospel truth” or “credible scientific evidence.”

You see they need that control over the studies so that they can make
statements like this: “There is no credible scientific evidence that
establishes a causal link between Prozac [fluoxetine hydrochloride] and
violent or suicidal behavior.”

Dr. David Healy is perhaps their greatest threat when it comes to the SSRIs.
I am sure that part of their motive was a hope that this move might become a
“black mark” on his resume that they could use against him in court to
discredit him. I know all too well that they will twist everything they can
to discredit those who have the courage to stand up for the truth against
them. And, Dr. Healy does that well.

I don’t know why they would not want anyone to hear what Dr. Healy is saying
about Prozac, such as: “the data show that Prozac and other popular
antidepressants in the same chemical family may have been responsible for one
suicide for every day they have been on the market.”

If I were the CEO of Lilly I would be thinking, “Wow! That would be a VERY
LARGE number of lawsuits to have to settle.” Now I can’t imagine what has
made them so upset as to ruin Dr. Healy’s new position, can you?

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

http://www.globeandmail.com/

Saturday, April 14

Prozac critic sees U of T job revoked

By ANNE McILROY
From Saturday’s Globe and Mail

A world-renowned scientist saw a job offer at the University of Toronto
evaporate after warning that the popular antidepressant Prozac may trigger
suicide in some patients.

The drug’s manufacturer, Eli Lilly, is an important private donor to a
mental-health research institute affiliated with the university.

Critics say it appears that David Healy’s job offer was rescinded to avoid
offending the corporate giant or for fear of compromising future fundraising
efforts.

Eli Lilly said it had no role in the matter. The university said the decision
not to hire Dr. Healy was made by the Centre for Addiction and Mental Health,
an affiliated teaching hospital, and that it would not be proper for the
university to question it. The Centre for Addiction and Mental Health, for
its part, steadfastly denies that it has allowed fundraising concerns to
interfere with academic freedom.

“If you are asking me if his comments influenced our decision, let me be
clear that there were a number of factors involved. We regret that our
actions have been misinterpreted as an attack against academic freedom and as
a conflict of interest,” said Paul Garfinkel, chief executive officer of the
CAMH.

Dr. Garfinkel said the reasons for the decision to revoke Dr. Healy’s job
offer are confidential. “Let me be clear, we’ve never made an offer or
withdrawn an offer on the basis of an impact on an outside donor.”

When initially approached by The Globe and Mail several months ago, Dr.
Healy, who works at the University of Wales, was reluctant to speak publicly
about what happened.

He said he decided to do so to publicize his concerns about Prozac and to
raise questions about the appearance of a conflict of interest at U of T.

“I’ve had people call from a number of countries asking whether it is safe to
say something [critical] about pharmaceutical companies. The public needs to
know what happened here,” he said in an interview.

Dr. Healy said that he made his views clear in private interviews with
university officials before the speech.

University of Toronto colleagues are providing a public platform for him to
express his views on Prozac next week. He will give a lecture at the Joint
Centre for Bioethics on Thursday evening.

U of T and CAMH had been courting Dr. Healy since July of 1999. They made him
a formal written offer of a combined faculty and clinical position in May of
2000, followed by a more detailed letter in August.
They hired a lawyer to help him immigrate.

Then, on Nov. 30, 2000, Dr. Healy gave a wide-ranging lecture at CAMH, part
of a colloquium titled Looking Back, Looking Ahead — Psychiatry in the 21st
Century: Mental Health and Addiction.

He criticized pharmaceutical companies for avoiding experiments that could
demonstrate problems with their drugs, and for not publishing unfavourable
results. He said the data show that Prozac and other popular antidepressants
in the same chemical family may have been responsible for one suicide for
every day they have been on the market.

A week later, Dr. David Goldbloom, physician-in-chief at CAMH and a professor
at U of T, rescinded the offer to Dr. Healy in an e-mail, a copy of which was
sent to The Globe and Mail in an unmarked brown envelope.

Dr. Goldbloom told Dr. Healy his lecture was evidence that his approach was
not “compatible” with development goals. Development, in the university
context, is widely understood to mean fundraising, although CAMH denies that
fundraising was what was meant.

Eli Lilly, the drug company that manufactures Prozac, is its “lead” donor
according to the CAMH Web site, contributing more than $1-million to the
centre’s $10-million capital-fundraising campaign.

Last year, Eli Lilly cancelled its $25,000 (U.S.) annual donation to the
Hastings Center in New York, a think tank that looks at ethical issues, after
it published a series of articles about Prozac, including a critical one by
Dr. Healy titled Good Science or Good Business.

“The centre had published articles that Lilly felt contained information that
was biased and scientifically unfounded and that may have led to significant
misinformation to readers, patients and the community,” said Laurel Swartz,
manager of corporate communications for Eli Lilly.

Two U of T professors, who have asked that their names not be published, said
that what happened to Dr. Healy in Canada raises disturbing questions about
whether professors are free to be critical of drug companies in an era where
medical schools are heavily dependent on them for financing.

James Turk, executive director of the Canadian Association of University
Teachers, said the paper trail appears to make it clear why Dr. Healy was no
longer welcome at U of T.

“The language they use indicates they feel they can’t hire this guy because
it will give them trouble raising money,” Mr. Turk said.

Experts such as Bob Michels, the former head of medicine at Cornell
University in New York, say Dr. Healy is internationally renowned, both as a
clinical psychopharmacologist and a historian of the role of drugs in modern
psychiatry.

He is also well-known for his outspoken criticism of Prozac and other similar
drugs and has appeared as an expert witness on behalf of families suing Eli
Lilly and other drug companies.

Dr. Healy says the data show Prozac and related medications, which are widely
prescribed for people who in the past would not be deemed sick enough to
require medication, can cause patients with no history of mental illness to
fall into a state of extreme agitation anxiety. In some cases it can lead to
suicide, or thoughts of suicide.

Last year, Dr. Healy published a study that found that two healthy volunteers
out of 20 who were given Prozac reported feeling extremely anxious and that
they entertained thoughts of suicide.

Eli Lilly says Prozac is safe. “There is no credible scientific evidence that
establishes a causal link between Prozac [fluoxetine hydrochloride] and
violent or suicidal behaviour,” Ms. Swartz said.

Dr. Healy insists warning labels are needed on Prozac so doctors will know to
watch for suicidal tendencies when they prescribe the antidepressant.

His speech did not go over well at U of T. Dr. Healy said Dr. Goldbloom
appeared unhappy when they discussed the lecture at a dinner that evening.

Dr. Healy said he understood Dr. Goldbloom to be critical of his speech
because people would take away from it the understanding that Prozac makes
people suicidal and the Eli Lilly knew about the problem but wouldn’t
acknowledge it.

Dr. Healy left that weekend for New York, where he was scheduled to give the
same speech at Cornell University.

On the Monday after the Thursday speech, Dr. Goldbloom began sending Dr.
Healy e-mails saying it was urgent they find a time to talk by telephone. Dr.
Healy kept copies of them, and has provided them to The Globe and Mail.

When the two men couldn’t arrange the phone call, Dr. Goldbloom sent the
e-mail rescinding the job offer on behalf of both CAMH and U of T.

“Essentially, we believe that it is not a good fit between you and the role
of leader of an academic program in mood and anxiety disorders at the Centre
and in relation to the University. This view was solidified by your recent
appearance at the Centre in the context of an academic lecture,” the message
said.

“While you are held in high regard as a scholar of the history of modern
psychiatry, we do not feel your approach is compatible with the goals for
development of the academic and clinical resource that we have.”

Dr. Goldbloom would not be interviewed for this story. Dr. Garfinkel said he
didn’t know what Dr. Goldbloom had said to Dr. Healy in person after the
speech. But he categorically denied that when Dr. Goldbloom referred to the
development of the centre he was referring in any way to the ability to raise
funds, either from Eli Lilly or other drug companies.

“Development is a technical term that many places use to talk about
fundraising. This is development of a program, totally different meaning,”
Dr. Garfinkel said.

He said the meeting where senior managers from U of T and CAMH made the
decision to rescind the job offer was on Dec. 8. Yet Dr. Goldbloom sent the
e-mail on Dec. 7, and began requesting an interview by phone several days
before that.

Dr. Healy didn’t quit his job in Wales and said he is not planning legal
action. He said he has asked for a more detailed explanation about why the
job offer was rescinded, but none was given. He said he would like to hear
from Dr. Garfinkel about the confidential reasons the job offer was revoked.

“Nobody has offered me any other reasons at all. I don’t believe there are
any other reasons. We have the paper trail, and what I am asking them to
explain is the paper trail. Maybe there is an explanation that will let them
off the hook, but if there is, maybe they could try explaining it to me.”

He certainly never imagined that his speech, which contained nothing he
hasn’t said before, would cost him the job.

In fact, Dr. Michels said the same speech did not cause problems at Cornell.

“He certainly has many people who sharply differ with him. That’s not unusual
in science. He has points of view that other people don’t agree with. He has
certainly been very open and expressive about his points of view. The
material is an area where there is great controversy, and he takes positions
in that controversy, but they are well within the dialogue in his field.”

This is the second controversy of its kind at the university. Researcher
Nancy Olivieri faced an ugly internal battle and a lawsuit in when she
published data unfavourable to the drug company that funded her work.

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4/09/2001 – Ghostwriting Articles for Medical Journals

Dennis Silver, who serves as webmaster for the Prozac: Panacea or Pandora?
website (members.aol.com/atracyphd), has just brought to our attention an
amazing article from CBS Health Watch. In the ten years I have been fighting
this battle to get the truth out to the public about what goes on behind the
scenes in medcine this strikes at the heart of the issue like no other!

As I did the research for my book I was appalled at the difference in the
studies on serotonin BEFORE the development of the SSRIs and the studies
being published on serotonin AFTER and during the development of the SSRI
antidepressants. It was clear to me that the drug companies were manipulating
the science to build a market for their drugs. It was as if the new studies
were contradicting the old studies. Truth is consistent not variable. It was
clear something had changed. I say BRAVO!!! to CBS and to Dr. Marcia Angell,
former editor of the New England Journal of Medicine, who has worked hard to
expose this situation over the last year or so! Thank you for demonstrating
that integrity still exists in our country by exposing those with no
knowledge of what integrity is.

Note how the spokesperson for Wythe Ayers justifies their criminal behavior
with the same old line: “well everyone else does it too.”

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

http://cbshealthwatch.medscape.com/medscape/p/G_Library/article.asp?RecId=2381

64&FA=1&SP=undefined

Ghostwriting Articles for Medical Journals

April 5 (CBS) Amidst the billion-dollar competition to create the newest
blockbuster drug, there’s one thing worth more than all the ads money can
buy: a single positive mention in a respected medical journal. Doctors rely
so heavily on what’s printed in journals that a drug’s success or failure may
be directly affected.

Now, many drug companies are actually writing those articles and then paying
doctors to sign their names to them. It’s called ghostwriting, reports CBS
News Correspondent Sharyl Attkisson.

“The articles are written by drug company researchers, given to an outside
doctor to review and sign his or her name to, and then submitted to a
journal. In effect, it’s like washing dirty money,” explains Douglas Peters,
a medical malpractice attorney.

It’s not illegal, but it can be misleading.

Critics say that’s just what happened when Wyeth-Ayerst wanted to create a
market demand for its “fen-phen” diet drug, Redux.

Wyeth hired a middleman, a company called Excerpta Medica, to write and get
published nine medical journal articles on Redux. Excerpta paid doctors to
review and sign the articles, then submitted them to journals with no mention
of Wyeth. Excerpta claims it told the doctors that Wyeth was behind all of
it.

But Dr. Richard Atkinson, a professor of medicine and nutritional sciences
and the director of the Beers-Murphy Clinical Nutrition Center at the
University of Wisconsin Madison Medical School, says he wasn’t told. He
reviewed and signed one of those Redux papers thinking Excerpta was an
independent researcher, he says.

“If I knew that a drug company had some role, whatever role, in sponsoring a
talk, an article, a symposium, whatever, I think I would be more on my guard
to make sure that there was not any bias introduced,” says Atkinson.

Biased literature can make a drug sound better or safer than it really is.
And unbeknownst to most doctors, it’s even finding its way into the most
respected medical journals.

Dr. Marcia Angell, former editor of the New England Journal of Medicine, says
that as time passed she was getting more and more ghostwritten papers.

“A drug company that controls the data and has a ghostwriter writing the
paper may neglect to write about the side effects of a drug,” says Angell.

In a deposition on January 15, 1999, former Wyeth executive Jo Alene Dolan
said all drug companies ghostwrite, but it doesn’t mean the articles aren’t
accurate.

When questioned about Atkinson’s article, she said, “Apparently we wrote this
article for him.” She was then asked if it was bought and paid for by
Wyeth-Ayerst and replied, “I’m not sure that’s the way I would characterize
it. It was funded by Wyeth-Ayerst.”

Yet Wyeth’s middleman, Excerpta Medica, claims it doesn’t ghostwrite. It says
it “facilitates,” that doctors always know about drug industry involvement,
and that “the author has final editing authority.”

Atkinson did tell Excerpta that article may make Redux “sound better than it
really is” and suggested some changes. But before the article could be
published, Redux was linked to heart and lung problems and pulled from the
market.

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4/9/2001 – FDA Doc Claims Fen-Phen Cover Up

Once again the CBS Health Watch has given us another great article – this
time on the subject of corruption in the FDA.

With this revelation about the cover up with Fen-Phen let us hope that the
truth will begin to come out about the rest of these dangerous serotonergic
drugs. The real shame about Fen-Phen and Redux is that the drug company is
still getting away with all the psychiatric side effects their drugs
produced. The serotonergic effect with these drugs produced as many psychotic
breaks as the SSRIs have and in the end we will see that the SSRIs are
producing similar heart and lung problems as Fen-Phen and Redux did.

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

http://cbshealthwatch.medscape.com/SRS/c/ShowDoc.asp?ContentID=214123&ContentType=5

FDA Doc Claims Fen-Phen Cover Up

April 7 (CBS) The drug company that manufactured “fen-phen,” a diet
medication linked to heart ailments, covered up problems with the drug that
emerged during Food and Drug Administration testing, a former FDA scientist
tells CBS News.

Fen-phen was removed from the market in 1997. Thousands of people who took
the drug have sued American Home Products of Madison, N.J., for health
problems they claim the drug caused.

In an Eye on America investigation, CBS News Correspondent Sharyl Attkisson
reports the FDA’s key reviewer of fen-phen, Dr. Leo Lutwak, claims the
company knew about the problems long before the drug was pulled.

“I felt from the very beginning the drug companies were covering up. I felt
from the very beginning that these drugs were dangerous,” said Lutwak.

He claims American Home Products twisted the meaning of his research to make
it seem as if there was no way to predict fen-phen’s hazards.

“What I had actually written was, that in view of the covering up of
information by the drug company, the FDA had no way of predicting some of
these side effects,” he said.

One of those who sued American Home Products was Patricia Buol, who developed
severe heart problems after taking fen-phen. She’s now in line for a life
saving heart-lung transplant.

The company settled with Buol this week.

“Being part of my kids’ lives and doing their everyday activities is a
struggle,” said Buol. “But I just take one day at a time and do the best I
can.”

Dr. Lutwak’s testimony is crucial to fen-phen cases like Buol’s. But the FDA
won’t let him testify. Now Lutwak says he’s planning to retire, making him
free to testify at will.

“I followed the rules and regulations, I didn’t go public. I tried to work
within the system, it didn’t work. People died as a result of a dangerous
deadly drug being released,”he said.

Defendant American Home Products would not be interviewed, but has said in
the past it “acted responsibly and lawfully.”

FDA Commissioner Jane Henney refused a CBS News request to answer the
allegations.

The agency’s last commissioner, Dr. David Kessler, criticized the agency’s
current approach to drug regulation.

“I have some concerns that we may be losing sight of what the FDA is all
about,” said Kessler. “The question is, who’s the agency’s customers? Who’s
the agency partner?”

Consumer advocates say the FDA is constantly keeping damaging information
from the public.

“They view the drug industry in many ways as their customers, at least the
bosses do, as opposed to viewing the public as the customers they need to
protect from some of the excesses of the drug industry,” said Sidney Wolfe of
Public Citizen.

Concerns about the FDA also emerged during the controversy over the diabetes
drug Rezulin.

Kessler said the agency needs to realize the American consumer is its
customer.

American Home Products also makes such drugs as Caordarone, Sectral,
Protonix, Synvisc and Pnu-Imune.

Fen-phen is actually a combination of two drugs, fenfluramine and
phentermine, which work by suppressing the appetite of a person who is trying
to lose weight.

It was estimated that in 1996, 18 million Americans took the drugs.

But a report in the August 1997 New England Journal of Medicine found that
fenfluramine can in some cases lead to pulmonary hypertension, a rare, almost
always fatal, disease. It was also linked to heart valve malfunction.

In September, 1997, the FDA, saying it was “acting on new evidence about
significant side-effects,” asked the manufacturers to voluntarily withdraw
both medications, marketed under the names Pondimin (fen-phen), and Redux, a
similar medication.

Wyeth-Ayerst Laboratories, a subsidiary of American Home Products, complied.

However, the company continued to deny the drugs caused the alleged problems.
In November, 1998, Wyeth-Ayerst published a study that compared heart
function in people who had taken fen-phen and a group who hadn’t, and
concluded there was “no significant differences in cardiovascular clinical
outcomes.”

But that didn’t stop the fen-phen fallout.

A February, 1999 60 Minutes II investigation with U.S. News & World Report
revealed that Wyeth-Ayerst knew more than it told about the pulmonary
hypertension risks, a charge the company denied.

In September 1999, the Wall Street Journal reported that the FBI was
investigating the FDA’s approval of Redux.

A month later, American Home Products agreed to pay up to $4.83 billion to
settle the more than 11,000 fen-phen lawsuits, one of the biggest product
liability settlements ever.

As part of the settlement agreement, the company admitted no wrongdoing.

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3/30/2001 – LSD to Prozac and back to LSD?!

In the last half century we have witnessed Eli Lilly bring America LSD and
then Prozac. Now that the public has been brainwashed about the “benefits” of
Prozac and its clones, it is time to once again attempt to sell us on LSD.
After admitting in this article the truth of the argument I have made for ten
years against the SSRI antidepressants – they work like LSD in the brain (”
Nichols says there is some indication these drugs work on the serotonin
pathway in the brain, the same target of the selective serotonin reuptake
inhibitor drugs Prozac, Paxil and Zoloft, used to treat depression, anxiety
and obsessive compulsive disorder.”) they now work to sell us on the
“benefits” of LSD. After all, if we can as a society have given similar drugs
– the SSRIs – such a warm welcome, we must now be ready to accept LSD, the
CIA’s drug of choice for a mind control experimentation, with welcome arms as
well.

Has the world gone completely mad?! Obviously! We now have the National
Institute on Drug Abuse encouraging us to use a drug, already declared
dangerous and of no medical use, when they are suppose to educate us on the
dangers of it. Perhaps the name of the institute should be changed to the
National Institute for Production of Drug Abuse. At this point it would
certainly be more appropriate. Clearly they are counting on their lack of
educating the public about drugs to have produced enough public ignorance of
drugs and their effects so as to allow them to get away with this one. As I
have said repeatedly, the drug companies count on our memory loss. They
expect us to forget within a generation our experience with a drug and then
pull the same drug on us again. They generally give it a new name, or a new
twist, but the more you learn about drugs, the more you realize that the
drugs remain the same.

Obviously on this one they are counting on mass stupidity among the general
population for its acceptance. I would hope that everyone of you is working
as hard as you can to educate all around you to the dangers of these drugs.
Time is of the essence! If you have not yet figured out that we are in a
battle for our lives, you have missed something. Our society as we have known
it and our future is at stake. The Brave New World is here. And with them
feeling so confident as to take such a bold and blatant step as this all that
can be said at this point is, “God help us all!”

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

http://abcnews.go.com/sections/living/DailyNews/hallucinogen010322.html

A computer-generated model of the LSD molecule. (Heffter Institute)

MedicalHallucinogens?

Researchers Studying Possible Medical Use of LSD, Peyote, Psilocybin

By Robin Eisner

N E W Y O R K, March 22 Could shrooms or LSD help the mentally ill?

STORY HIGHLIGHTS
Hallucinogens Among Oldest Drugs
Trials Must Be Rigorously Designed
Critics: Risks Outweigh Benefits

At Harvard, a psychiatrist is studying whether the hallucinogenic cactus
peyote creates any long-term memory or attention problems in the American
Indians who take the drug as part of religious rituals.

A University of Arizona psychiatrist is poised to begin researching whether
taking the hallucinogen psilocybin under controlled circumstances may help
people suffering with obsessive compulsive disorder.

And another Harvard psychiatrist is in the beginning phases of designing a
protocol that may employ LSD or another hallucinogen to see if it helps
terminally ill people suffering from depression and pain.

With some support from the private New Mexico-based Heffter Institute, these
researchers, along with others in the United States and abroad, represent a
small movement of scientists looking at the possible medical benefits of
hallucinogens for some psychiatric conditions.

Hallucinogens Among Oldest Drugs

Hallucinogens are among the oldest known group of drugs that have been used
for their ability to alter human perception and mood, according to the Drug
Enforcement Agency. They have been used for medical, social and religious
practices.

More recently, synthetic hallucinogens have been used recreationally, with
hippies from the ’60s, such as the now deceased ex-Harvard psychology
professor Timothy Leary, first promoting their use with the famous slogan,
Turn on, Tune in, Drop Out.

Today, hallucinogens are deemed drugs of abuse by the DEA, with no known
medical benefit. Approximately 8 percent to 10 percent of high school
seniors tried a hallucinogen in the past year according to a University of
Michigan study of drug use.

It remains unclear how these drugs exert their action in the brain, but
anecdotal evidence and some earlier studies indicate they may help a variety
of psychiatric conditions, says David E. Nichols, founder of the Heffter
Institute, in Santa Fe, and professor of medical chemistry and molecular
pharmacology at Purdue School of Pharmacy in West Lafayette, Ind.

Nichols says there is some indication these drugs work on the serotonin
pathway in the brain, the same target of the selective serotonin reuptake
inhibitor drugs Prozac, Paxil and Zoloft, used to treat depression, anxiety
and obsessive compulsive disorder.

He founded the institute in 1993 to help give scientific credibility to
medical research on hallucinogens. After years of fund-raising, the
institute now has enough money to help scientists do serious research.

Trials Must Be Rigorously Designed

Since opinions are so strongly held about hallucinogens, it is essential
that any studies in this area be performed with the most rigorous modern
methods and great care to have an impartial approach, says Dr. Harrison
Pope, professor of psychiatry at Harvard Medical School, who is leading the
four-year peyote study in American Indians.

Funded largely by the National Institute of Drug Abuse and Heffter, Popes
group will be comparing three populations of American Indians peyote users
in religious ceremonies, alcoholics, and local tribespeople to see if
peyote use is associated with cognitive problems.

Pope is also developing a trial to follow up on studies from the ’60s and
’70s suggesting that hallucinogens helped ease anxiety and depression in the
terminally ill and also reduced their need for pain medication.

The challenge is to design the study in such a way that if the drug shows
benefits, skeptics are convinced, and if it doesnt help, proponents of
hallucinogenic use dont challenge the research as inadequate, Pope says.

Psilocybin mushroom

These studies take time to develop to get that scientific imprimatur. They
also need to get review, by local medical institutions and governmental
regulatory authorities. The DEA and the FDA is still reviewing a protocol by
Dr. Francisco Moreno, an assistant professor of psychiatry at the University
of Arizona in Tucson, hoping to study a chemically synthesized psilocybin
for obsessive-compulsives. His hospital gave him permission to start the
study.

A protocol of psilocybin and depression in Switzerland also is undergoing
revision before it is submitted to the government authorities there, Nichols
says.

Critics: Risks Outweigh Benefits

Some scientists, however, question the potential risks of these studies.

The problem with this kind of research is that when average people hear or
read about them in this preliminary stage they might think these drugs could
be good for them now, says Una McCann, associate professor of psychiatry at
Johns Hopkins School of Medicine. But it remains unknown until the studies
are finished, McCann says.

Dr. Gregory Collins the director of the Alcohol and Drug Recovery program at
the Cleveland Clinic, in Cleveland, Ohio, believes the risks outweigh any
benefits.

Some of these drugs have been shown to have long-term consequences in
healthy people, Collins says. I would be reluctant to try them in the
mentally ill.

Nichols, however, defends the research. I think we will find some medical
benefit of these drugs, Nichols says. There is no other drug class that
doesnt have some medical utility.

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3/29/2001 – Celexa recommended for elderly

This is beyond sickening! Celexa has the strongest effect upon serotonin
reuptake as any of the other SSRIs and is therefore, the most dangerous in
this group of serotonergic drugs. To encourage it for use in the elderly,
some of the most vulnerable in our society, for minor depression is
unconscionable!

Now that the ad has run in Medscape encouraging doctors to prescribe it (as
if they needed any encouragement in their mass drugging of America!) you may
want to begin checking the obituaries for large numbers of the elderly dying.
Of course it will save the government lots of $$$ in Social Security payments!

Ann Blake-Tracy, Executive Director,
International Coalition For Drug Awareness
www.drugawareness.org
_
Subject: Psychiatry MedPulse 02-Mar-01 — MEDSCAPE
______________________________________________________________________
MEDSCAPE’s Psychiatry MedPulse(R) <<<
http://psychiatry.medscape.com
_______________________________________________________________________

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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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1/11/2001 – More Self Harm Seen with SSRI Therapy Than With Tricyclics

Now, a report out of the UK debunks a popular marketing
strategem of SSRI manufacturers–that SSRI’s are inherently
safer because they are less toxic in overdose. This study
recently published in the British Journal of Psychiatry clearly
points to a great risk of self-harm with drugs like Prozac, Zoloft
and Paxil over the older tricyclic antidepressants. Mark
———

More Self Harm Seen with SSRI Therapy Than With Tricyclics

http://psychiatry.medscape.com/reuters/prof/2000/12/12.29/20001228clin013.html

WESTPORT, CT (Reuters Health) Dec 28 – Significantly more
instances of deliberate self-harm occur in patients prescribed a
selective serotonin reuptake inhibitor (SSRI) than in those
prescribed a tricyclic antidepressant (TCA). In their report in the
December issue of the British Journal of Psychiatry, UK
investigators caution that the choice of antidepressant for
patients at risk should not be based solely on overdose toxicity.

In this prospective study, 2776 deliberate self-harm events
occurred in 1954 individuals attending the Derbyshire Royal
Infirmary in 1995 and 1996. Dr. Stuart Donovan, of University
Hospital, in Nottingham, and associates observed that the most
frequent method of self-harm was medication overdose, and
paracetamol (acetaminophen) was the medication most
frequently involved

In the cases of antidepressant overdoses, SSRIs were used
more often than TCAs, in 16.0 and 11.8 cases per 10,000
prescriptions, respectively. The relative incidence of self-harm
events was significantly higher in those prescribed SSRIs than
in those prescribed TCAs. Exposure times were similar for the
two types of drugs.

Dr. Donovan’s group adds that SSRIs may have been prescribed
more often following unsuccessful use of a TCA, making it
possible that “a greater proportion of more ‘difficult to treat’
patients may have been prescribed SSRIs and this may
manifest as a greater risk of deliberate self-harm.” However, they
emphasize that the reduced overdose toxicity of SSRIs
compared with TCAs “does not extrapolate to a reduced risk of
deliberate self-harm.”

In fact, the reduced risk of morbidity following overdose is offset
by the higher risk of self-harm by other methods in patients
taking SSRIs.

Br J Psychiatry 2000;177:551-556.
Copyright © 2000 Reuters Ltd. All rights reserved.

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