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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4/13/2001 – Drugs not genes cause birth defects in babies of epileptic women

Thanks to our director in Norway we have this new information out of the
Guardian in the UK on anti-seizure meds. Anti-seizure meds are often given
along with antidepressants due to the seizure activity induced by the
antidepressants. This seizure activity manifests itself in various forms
including mania – a condition in which the brain is in a continuous mild
seizure activity that alters ones consciousness and behavior.

Note this statement in particular: “They found that the babies of women who
had taken drugs for epilepsy had a much higher rate of birth defects – 20.6%
of infants exposed to one drug, and 28% of infants exposed to two or more
drugs in the womb. This figure compared with 8.5% of those having birth
defects and mothers who had taken nothing.”

With that information in mind recall that Jeffrey Dahmer’s mother was taking
23 pills daily, the large majority of those being anti-seizure meds. What
were his chances of birth defects or various forms of retarded development?
Why can we not understand that when a mother is on a mind-altering medication
that the baby’s brain is certainly going to be affected as well?

What a shame that these mothers are not made aware of simple alternatives
such as Omega 3 oils for seizures or Noni, the fruit juice out of Tahiti.
These are a couple of simple non-toxic solutions to the seizures for which
they are taking these damaging drugs.

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

http://www.guardian.co.uk/Archive/Article/0,4273,4169237,00.html

Drugs not genes cause birth defects in babies of epileptic women

Sarah Boseley, health editor

Guardian

Thursday April 12, 2001

Birth defects in the babies of women who take medicine for epilepsy while
they are pregnant are caused by the drugs and not by the epilepsy, according
to new research reported in the US.

The study, published in the New England Journal of Medicine today, claims
that the idea that the genetic abnormalities which cause the epilepsy are
then passed on to the foetus, is wrong.

Lewis B Holmes and his colleagues from the paediatric service of
Massachusetts general hospital, in Boston, say it is the medication which is
to blame for the children’s defects.

Since the 1970s it has been recognised that women taking the drugs most
frequently given to prevent epileptic fits, have a higher risk than usual of
giving birth to babies with certain malformations, such as abnormalities of
the face and fingers, and retarded growth.

The Massachusetts team examined 316 babies born to women who had taken
anticonvulsant drugs during pregnancy and 98 babies of women with a history
of epilepsy who had not had the medication.

They compared the babies with 508 other babies whose mothers did not have
epilepsy and had not taken medication while pregnant.

They found that the babies of women who had taken drugs for epilepsy had a
much higher rate of birth defects – 20.6% of infants exposed to one drug, and
28% of infants exposed to two or more drugs in the womb. This figure compared
with 8.5% of those having birth defects and mothers who had taken nothing.

Women with epilepsy who had not taken drugs in pregnancy were no more likely
to have a baby with birth defects than women who had no history of the
disease.

The research poses a big dilemma for women with epilepsy, as stopping the
medication would put some women and their unborn babies at risk of damage
from seizures.

A spokeswoman for the British Epilepsy Association said it might not always
occur to GPs to raise the issue with their female patients. “But it is really
important for all women with epilepsy who are planning a family to go and
seek specialist advice beforehand so that the medication can be looked at and
then possibly changed,” she said.

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4/13/2001 – Another school shooting & antidepressants

Well, now that it is public information we can let you know that once again
antidepressants were involved in another of the recent school shootings. Beth
Bush had been on antidepressants before shooting a classmate. This article is
from the Washington Post. Of course we are led to believe that the
“antidepressants failed to help”, rather than being educated to the fact that
they were the CAUSE of the shooting.

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

http://www.washingtonpost.com/wp-dyn/nation/latestap/A13049-2001Apr12.html

H.S. Shooter Talks of Taunting

The Associated Press
Thursday, April 12, 2001; 9:19 PM

WILLIAMSPORT, Pa. A 14-year-old girl said she shot a classmate last month
to make the victim “know my pain” from repeated teasing and taunting.

Elizabeth Bush told the ABC News program “20/20” that the shooting has played
over repeatedly in her mind since March 7, the day she shot Kim Marchese at
the cafeteria of Bishop Neumann Junior-Senior High School.

Elizabeth, who had transferred into the school a year earlier, told
interviewer Connie Chung that she was deeply depressed and counseling and
anti-depressants failed to help.

“They’d just call me an idiot, stupid, fat, ugly, faggot, whatever,”
Elizabeth said in the interview, which is scheduled to air Friday.

Elizabeth said her depression caused her to cut her arms with a razor. She
said Kim had befriended her but told others about the self-mutilation,
leaving her feeling betrayed.

“People express their anger different ways,” Elizabeth said. “Crying helps.
That didn’t help me. So I thought maybe I’d try this and maybe it will help.
And it’s just like the actually the pain is it just takes away all your
depression and for a minute you’re not depressed anymore.”

She was sentenced April 4 to an open-ended term at a psychiatric facility.

Kim Marchese, who was wounded in the right shoulder, told Chung that she now
knows she should have acted differently.

“I knew the teasing was wrong and that’s why I asked her if it was bothering
her so I would stop,” Kim said, “I mean, I should have stopped right away.”

© 2001 The Associated Press

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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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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

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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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For complete prescribing information about Celexa
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3/18/2001 – New MMR link to autism

Additional immunization woes surface linking autism once again to the MMR
vaccine. Parents with infants facing immunizations should be warned of this
as it always takes years for authorities like the FDA or CDC to get around to
doing it.

What is interesting to note is the leaky gut connection to brain damage
mentioned in the article. Reports of leaky gut are quite common with the
SSRIs as well as is the report of autistic tendencies.

We know that high serotonin levels are linked to autism.

And we know that over 90% of the serotonin in the body is produced in the
colon. (This is why so many intestinal side effects are related to these
serotonergic medications.)

The next piece of the puzzle would be to learn that high serotonin is linked
to the leaky gut. I believe that Dr. Michael Gershon at Columbia Presbyterian
has given us that information in his research on intestinal problems and
SSRIs, indicating that these side effects come from the high serotonin. The
answers to this connection should be found in his new book “The Gut Brain”.

For additional information on vaccines producing problems in brain function
and brain toxicity go to the www.drugawareness.org site and read “US
Congressman Dan Burton Requests Immediate Vaccine Recall.” Congressman Burton
is concerned about the mercury content in vaccines. Mark has posted this
article on our front page this month.

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

Sunday 18 March 2001

New MMR link to autism

The most compelling evidence to date of a link between MMR injections and
autism has been announced by scientists. Researchers working on two separate
studies have linked brain dysfunction to physical abnormalities which could
have been triggered by the multiple vaccine. The new evidence is based on
clinical tests rather than analysis of statistical information. Scientists
investigated the physical symptoms and were able to put samples rather than
numbers under the microscope.

The head of Britain’s Autism Research Unit said the studies represented the
most important research into the condition ever carried out. Until now autism
has been seen as a purely mental disorder. One report from the Royal Free
Hospital in London has now found that many autistic children suffer from a
condition know as ‘leaky gut syndrome,’ a disease which damages the walls of
the intestine and is often found in children with autism, but is rare among
other children. Research suggests that these symptoms could be triggered by a
reaction to the MMR jab. Simon Murch, child specialist and the report’s
author, believes the studies represent an important advance: ‘We have shown
for the first time in a properly controlled study a clear link between gut
inflammation and brain damage.’ A second study conducted in the US suggests
that vaccines can cause children’s immune systems to go out of control. The
study investigated 35 autistic children and found 27 had abnormal immune
systems, with the abnormalities apparently triggered by vaccines or other
external factors.

Government officials treated the results with caution yesterday. David
Salisbury, head of vaccines at the Department of Health, said his advisors
had examined evidence from the Royal Free hospital and could not support
their findings: ‘We have looked at this work and the conclusions are not
convincing,’ he said.

Sunday Express

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3/17/2001 – Doctor Links Viagra to Five Cases of Blindness

I have made the statement before that Viagra is a very dangerous drug and the
only good thing about it is that it will give Pfizer the funds they need to
pay off all of their Zoloft wrongful death suits while it remains to be seen
which new Pfizer drug will bring in the funds to pay off all of the Viagra
damage suits.

It appears the serious physical effects have begun to surface in spite of
most major drug company’s ability to suppress this type of information.

A Washington State man claimed Viagra drove him to attack a woman with a
hammer soon after the drug was released. And I just investigated the case of
a police officer who committed a murder/suicide while on Viagra. It will be
interesting to see how many more reports begin to come in as the public
becomes more aware of the serious effects of this new wonder drug.

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

http://dailynews.yahoo.com/htx/nm/20010312/hl/viagra_blind_1.html

Monday March 12 12:07 PM ET

Doctor Links Viagra to Five Cases of Blindness

By Edward Tobin

NEW YORK (Reuters) – A US ophthalmologist says there
appears to be a very small risk that men taking the
impotence drug Viagra could suffer permanent vision
loss, but the firm that makes the drug on Friday
played down the reported threat.

Howard Pomeranz, director of neuro-ophthalmology at
the University of Maryland Medical Center, said he
knows of five men across the United States who were
diagnosed with permanent vision loss by doctors after
taking the impotence drug. More than 10 million people
have taken the drug since it was approved in 1998.

The condition, called ischemic optic neuropathy, is
caused after blood flow is cut off to the optic nerve
in the eyeball. It usually occurs in people with
diabetes, hypertension and other vascular disorders.

A spokesman for Pfizer Inc., which makes Viagra,
dismissed Pomeranz’s observations, which were first
presented at the American Academy of Ophthalmology
Conference in Dallas in November. The company
spokesman told Reuters that the three-year old product
is not a threat to its users.

“From all clinical experience with Viagra, there have
been no cases of treatment-related blindness reported,
and reports of serious visual problems have been
extremely rare,” said Geoff Cook, the Pfizer
spokesman.

Viagra, which is available in 100 countries, is known
to cause some temporary vision problems such as
blue/green color distortions in some patients.

Blood Flow To Optic Nerve Constricted

Pomeranz said the five men diagnosed with the
condition after taking Viagra had a low cup-to-disk
ratio, which is a way doctors measure the small
circular indentation where the optic nerve connects to
the eyeball.

The low cup-to-disk ratio means that the blood vessels
and nerves are tightly bundled together into the small
space in the back of the eye, according to a
University of Maryland release about the issue.

“We know that Viagra regulates a chemical in the body
to constrict the arteries. The constriction may cut
off the blood flow to the optic nerve, especially in
people with a low cup-to-disk ratio, where the blood
vessels and nerves are tightly bundled,” Pomeranz
said in the release.

Pfizer’s Cook associated potential permanent visual
damage with the known risk factors for men taking the
drug, such as diabetes, and not the drug itself.

“In the population of men who take Viagra, many men
with diabetes and other conditions have significant
associations with long term visual problems,” he
said.

The US Food and Drug Administration (FDA), which
reviews reports of drug side effects, said it had not
received any complaints of sudden blindness in
patients taking Viagra.

“We do not have any reports of people losing their
sight like that,” FDA spokeswoman Susan Cruzan said.

“We would take any such reports seriously, and we
encourage health professionals to submit any such
information to us,” she added.

Leonard Yaffe, analyst with Banc of America
Securities, said more information was needed before
evaluating what effect the report would have on
Pfizer. “I’d want to know how often the men were
taking the drug, for how long a period of time?” he
said. “You need to know a lot more than these five
guys had this problem.”

Pomeranz, who is also assistant professor of
ophthalmology and neurology at the University of
Maryland School of Medicine, called for more research
into the matter.

“People who take Viagra who have this particular
configuration of their optic nerve at least need to be
aware that this is a potential problem that may occur
if they use this medication,” he said. “Whether this
is a significant increased risk, I don’t have the
statistics to back that up.”

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