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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3/17/2001 – 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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2/25/2001 – How drug firms reach the heart of government – stalking US corridor

Our thanks to the British newspaper, The Guardian, for exposing this
corruption in our government. The political ties of the drug companies is key
to understanding why we have drugs remaining on the market that the developer
came out against three years ago calling them “monsters” she has created.

Over the last several years I have watched, breathlessly asking “WHY?”, as
the mergers have continued with these companies making their power and
influence greater and greater in our world. Why this has not been stopped is
clear – our leaders have sold us out to the highest bidder through
“politically correct” bribes paid to those in office in the form of donations
to campaigns by these companies, not to mention the perks coming from their
lobbyists.

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

“However, the real debate has arguably not been put before the American
public with any clarity, because the extent to which the pharmaceutical
industry in the US has been able to set the policy-making agenda remains
invisible to the average voter.”

“There was a time not long ago when the corporate giants that PhRMA
represents were merely the size of nations. Now, after a frenzied two-year
period of pharmaceutical mega-mergers, they are behemoths which outweigh
entire continents.

The combined worth of the world’s top five drug companies is twice
the combined GDP of all sub-Saharan Africa and their influence on the rules
of world trade is many times stronger because they can bring their wealth to
bear directly on the levers of western power. ”

http://www.guardianunlimited.co.uk/international/story/0,3604,437212,00.html

or see article at: http://www.mercola.com/2001/feb/24/drug_industry.htm

Industry that stalks the US corridors of power

In the second part of a series – how drug firms reach the heart of government

Special report: George Bush’s America

Julian Borger in Washington
Tuesday February 13, 2001
The Guardian

Washington teems with a thousand industrial lobbyists. They cluster around
the band of luxury offices and expensive restaurants which stretches from the
White House to the Capitol building – a two-mile axis along which money and
power are constantly traded.

In this pantheon of corporate muscle, no industry wields as much power as the
Pharmaceutical Research and Manufacturers Association (PhRMA), a pressure
group breathtaking for its deep pockets and aggression, even by the standards
of US politics.

There was a time not long ago when the corporate giants that PhRMA represents
were merely the size of nations. Now, after a frenzied two-year period of
pharmaceutical mega-mergers, they are behemoths which outweigh entire
continents.

The combined worth of the world’s top five drug companies is twice the
combined GDP of all sub-Saharan Africa and their influence on the rules of
world trade is many times stronger because they can bring their wealth to
bear directly on the levers of western power.

In the struggle between western patent rights and the rest of the world’s
need for affordable medicine, the few concessions handed to the developing
nations in the last year of the Clinton administration are likely to be
reversed under Bush. The US government is expected to return to its customary
role as a battering ram for the interests of the pharmaceutical industry and
the principle of intellectual property.

Until recently, the industry hedged its political bets, backing the Democrats
and Republicans more or less evenly at election time. But at the last
election, it gambled. With billions at stake in a heated debate over
prescription drug prices at home and a growing number of patent disputes
abroad, the drugmakers stacked their chips disproportionately behind George
Bush. The industry spent nearly 70% of its unprecedented $24.4m campaign war
chest on the Republicans.

The wager paid off – just – and PhRMA has emerged at the apotheosis of its
political clout, with grateful Republicans running the White House, Senate
and House of Representatives. Politicians it has supported are now in key
positions and it deploys 297 lobbyists – one for every two members of
Congress.

‘Super profits’

The pharmaceutical industry is therefore well-placed to defend profits which
have soared in recent years to 36% (measured as a return on equity). That
rate of return on investment is more than twice the US average. It is far and
away the most profitable major industry in the country.

These “super-profits” have been generated by the proliferation of new
pharmaceutical discoveries and the parallel spread of worldwide patents. They
are also a measure of PhRMA’s success in using its influence in government to
fight off the threat of domestic price caps and competition from generic
manufacturers producing cheap copies of its drugs.

The industry played a significant role in the drafting of Trips (trade
related intellectual property rights) – that section of the World Trade
Organisation’s trade rules which relate to respect for patents. PhRMA has
also made it a priority to ensure that the US government has enforced the
Trips rules in a manner beneficial to its neighbours.

In 1998, for example, it was revealed that Al Gore had bullied the South
African government with threats of sanctions if it bought cheaper generic
alternatives to brand-name Aids drugs, even though South Africa had the right
to do so under Trips.

The outcry over the vice-president’s role, particularly among black
Americans, led to one of the few setbacks the lobby has faced. In December
1999, Bill Clinton announced that the US trade representative (USTR), the
country’s chief negotiator and enforcer in trade disputes, would consult with
the health department on the impact of intellectual property laws on access
to essential medicines in the developing world.

This may have been little more than lip service. The USTR continued to put
pressure on Latin American countries to agree to patent laws. Its criticisms
of Argentina and Brazil, on its “watch list” of patent miscreants, closely
echo briefing documents supplied by PhRMA.

The industry defends its hard-nosed approach by pointing to the cost of
research and development (R&D) and by the high risks involved in such a
pioneering field. Jeff Trewitt, PhRMA’s spokesman, said: “Patents are the
lifeblood to innovation. It costs about $500m to develop each pill and the
arbitrary abrogation of patents is going to kill that off.”

While the past decade has undeniably been a period of extraordinary and
vigorous innovation, the link between the development of new drugs and the
industry’s breathtaking profit margins is not necessarily as straightforward
as PhRMA maintains.

Creative accounting

Drug prices in Europe are about 60% of US prices, yet European firms spend a
larger share of their revenues on R&D than their American counterparts. The
US companies spent more on marketing than on R&D in 1999 (the last full year
figures are available) and set aside more for profits.

Moreover, with a little creative accounting, all manner of expenditures have
been lodged under the R&D title, partly in the pursuit of tax rebates.

In fact, much of the R&D work on new drugs is government-funded. A study by
the Boston Globe newspaper in 1998 found the National Institutes of Health
(NIH) laboratories spent $1bn on drug and vaccine development in the 1996 tax
year, but only took in $27m in royalties.

In September 1999, it was pointed out to the director of the NIH, Harold
Varmus, that six HIV/Aids drugs, as well as anti-malarial treatments and
other medicines of vital interest to developing countries, had been invented
with public funds. The government therefore had the right under US law to use
the drugs in public health initiatives.

Dr Varmus dismissed the suggestion, echoing the industry line that:
“Undermining licensed intellectual property rights would, I believe,
unnecessarily jeopardise the development of important therapeutic drugs.”

James Love, who runs a Washington-based group called the Consumer Project on
Technology, sees the response as nonsensical because it was the NIH which did
the hard work of discovering and synthesising the drugs in question. “The
rest of the world will have to go however many years more of paying an
astronomical sum for something invented by the United States government,” he
said. “How can we expect Glaxo to share its intellectual property if the
United States government won’t share its intellectual property to save
millions of people. What does that say about the moral character of the
American public. We are responsible.”

However, the real debate has arguably not been put before the American public
with any clarity, because the extent to which the pharmaceutical industry in
the US has been able to set the policy-making agenda remains invisible to the
average voter. Ten years ago, its modest campaign contributions of $2.9m were
evenly shared between the two parties and all in the form of “hard money” –
federally regulated donations for use in a specific election campaign.

In the 2000 election cycle, 60% of the drugmakers’ $24.4m contributions were
in the form of “soft money” – legal unregulated cash paid to the parties’
national committees for supposedly general use.

One of the biggest players in the soft money game is a group with the
public-spirited title of Citizens for Better Medicare. For an organisation
which commissioned an estimated $35m in advertising in the last election,
Citizens for Better Medicare, maintains a remarkably small office in downtown
Washington.

“We are a broad-based coalition of patients, doctors and the industry, which
stands for a system based on competition, consumer empowerment and senior’s
choice,” Tim Ryan, its executive director said. In terms of funding, however,
he concedes the base is considerably narrower.

“We may have some contributions from individuals, but yes, we are largely
funded by the industry. We haven’t talked about figures, so I can’t tell you
the percentage,” he said.

The percentage is close to 100. Citizens for Better Medicare (CBM) was
founded and is funded by PhRMA and the drug industry. When it registered
itself for non-profit status, CBM declared itself as a PhRMA affiliate.
Before taking up his executive director position, Mr Ryan was PhRMA’s
marketing director.

CBM does not need a big staff or extensive premises because 98% of the money
coming in from the industry is funnelled straight out to a single advertising
producer, Alex Castellanos. Mr Castellanos’s other main clients last year
were the George Bush election campaign and the Republican National Committee.
He was responsible for the most notorious advertisement of the 2000 election,
in which the word Rats flashed subliminally on the screen during a discussion
of Al Gore’s healthcare proposals.

Key positions

There are other examples of how the distinction between the interests of the
pharmaceutical industry and the Bush presidency have blurred. There is a
fast-spinning revolving door between government and the pharmaceutical
industry. Mitch Daniels, the new director of the office of management and
budget in the White House, was formerly the vice-president for strategy and
policy at the pharmaceutical giant, Eli Lilly. Two members of the Bush
transition team, Anne Marie Lynch and Bill Walters, are PhRMA members. Three
others were seconded from big pharmaceutical firms.

“The PhRMA doesn’t need to lobby,” Democratic congressman Sherrod Brown said
in a memo to staff last month. “The industry is in the White House already.”

The industry has sympathetic politicians in key positions in Congress. Behind
George Bush, the biggest recipient of pharmaceutical funding in the last
election was Orrin Hatch, a conservative Republican from Utah, who chairs the
Senate judiciary committee and is therefore well-placed to influence patent
disputes.

The industry backed Senator Hatch to the tune of $340,000 and provided a
plane for him to travel about the country in his quixotic bid for the
Republican presidential nomination last year.

Tomorrow: Are western drug companies using the third world poor as guinea
pigs for their drug trials?

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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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02/20/2001 – Drug Trials – Give us your children!

This situation is only getting worse and fast! This incredible article by the
Boston Globe shows us the dangerous potential in using our babies as guinea
pigs. As I said in my article “Our Next Generation of Medical Guinea Pigs –
Our Prozac, Zoloft, and Paxil Babies,” warning of this and written two years
ago, “If witnessing our children suffer like this is not enough to wake us up
to this nightmare, I DO NOT WANT TO SEE WHAT IT WILL TAKE TO WAKE US UP!!!!”

This time I made sure to include a link so that if the article is cut off,
you can go to the original Boston Globe site and finish reading it. Please
share this with your family and friends.

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

http://www.boston.com/dailyglobe2/049/nation/Dangerous_dosageP.shtml

Dangerous dosage

To make pediatric medicine safer, thousands of children are being used to
test drugs originally designed for adults. Tragically, the side effects can
sometimes prove deadly

By Alice Dembner, Globe Staff, 2/18/2001

First in a series of occasional articles on medical trials involving children.

Gage Stevens might have taken his first steps that bleak morning in November
1999. And by his first birthday, he would probably have outgrown his one
persistent ailment – acid reflux. Instead, he lay in the Allegheny County,
Pa., morgue.

His mother, Gretchen Stewart, had taken him to a specialist at Children’s
Hospital of Pittsburgh the spring before he died, seeking to ease the baby’s
crying as the acid irritated his esophagus. Dr. Susan Orenstein recommended
Gage enter a study she was running to find ”the safest, most effective
treatment for esophagitis in infants” using the ”best available”
medications, according to the consent form Stewart signed.

But the experimental treatment triggered a heart rhythm disturbance that
killed the 9-month-old, the coroner found. By that time, the key drug,
Propulsid, had also been linked to many adult deaths.

”They told me they were just trying to see how effective it was. Had I known
it was a dangerous drug, I would never have let him take it. Who in their
right mind would?” said Stewart of Homestead, Pa., who has filed a wrongful
death suit against the doctor, the hospital, and the drug’s maker, Janssen
Pharmaceutica.

Medical experiments across the country appear to have killed at least eight
children and subjected hundreds more to harmful side effects in the last
seven years, according to an investigation by The Boston Globe. These
tragedies, ethicists suggest, are a harbinger of troubles ahead as a federal
push to test more medicines in children kicks into high gear this year.

An estimated 45,000 children are participating in industry-sponsored testing
of new drugs, up from about 16,000 in 1997, according to Christopher-Paul
Milne, senior research fellow at the Tufts University Center for the Study of
Drug Development. ”Although researchers are looking pretty hard at the
ethical issues, there’s greater risk if you increase the number of children
being studied,” he said.

The rush to experiment on children has been triggered by federal initiatives
intended to improve the safety of drugs for children. Three-quarters of the
medicines used in children have never been fully tested for safety and
effectiveness in them, including heavily prescribed drugs such as the asthma
medication Albuterol. And children have been hurt when doctors lacking that
information prescribed inappropriate doses of drugs marketed for adults.

In response to appeals from pediatricians, since late 1997, Congress has
offered drug companies a lucrative six-month extension of patents on drugs
already on the market if they test them on children. Also, as of last
December, Food and Drug Administration policy requires that any new drugs be
tested on children as well as adults.

Drug companies are already pouring an estimated $1 billion a year into
pediatric testing, according to CenterWatch of Boston, which tracks the
industry. The additional sales of a single blockbuster drug during an extra
six months without competition from cheaper generics could offset that entire
investment.

The increase in pediatric research, which builds on a longer tradition of
testing children in cancer and AIDS research, has brought some benefits.
Since 1997, 14 drugs have been newly labeled with instructions for use in
children as a result of the push, while studies on dozens more have been
completed and are awaiting review by the FDA. Many of the tests are safe and
ethical.

But an examination of research in children since 1994 shows that the potent
combination of vulnerable children, ambitious researchers, potential profits,
and weak oversight can hold great peril for those children. From deadly
infections in Memphis to a troubling misdiagnosis in Arkansas, children have
suffered in the name of science.

In the case of Propulsid, the manufacturer, the doctor, and Children’s
Hospital deny that the drug caused Gage’s death.

”We believe it’s not possible to establish a direct causal relationship with
the administration of the drug. We learned that the infant had been brought
to the ER several days prior [to his death] with serious respiratory
illness,” said Janssen spokesman Greg Panico.

However, county coroner Cyril Wecht is convinced that a reaction to the drug
– not a respiratory problem – killed the child. Although autopsy can never
prove arrhythmia, he said he ruled out all other possible causes.

”We’re satisfied that … we are not acting prematurely, unwisely, unfairly,
or unscientifically,” said Wecht, who is also a nationally known commentator
on high-profile cases.

Moreover, Propulsid was linked to potentially dangerous heart rhythm problems
even before it was approved for adult use in 1993. By 1997, as doctors
increasingly used their discretion to prescribe Propulsid to children despite
the lack of federal approval, the FDA stepped in. Armed with reports of
cardiac deaths of three young children taking Propulsid, regulators suggested
that Janssen test the drug in children or provide a stronger warning label.

Janssen provided the warning label but held off on its own large trials,
instead providing the drug free to researchers, including Dr. Orenstein in
Pittsburgh. Orenstein enrolled about 100 children in her study, which
compared Propulsid given with and without another drug, Tagamet, against a
placebo.

Neither Orenstein nor her lawyer responded to requests for interviews and
hospital officials declined to explain why the study was conducted in a way
that seemed contrary to the FDA warning that Tagamet might increase
Propulsid’s heart risk.

In the months after Gage’s death, the FDA received reports of more than 100
cardiac deaths in people taking Propulsid, including 19 children whose
doctors had prescribed it. Janssen pulled it from the market last July.

”The country is still learning how to study children ethically,” said
Robert Ward, chairman of the American Academy of Pediatrics Committee on
Drugs, stressing that he could not comment directly on the Propulsid case.

Cancer centers have been at the forefront of clinical testing in children,
with long-standing research programs for all forms of the disease. But even
they may not set the best example, despite good intentions.

Three children died of complications in an experiment at the internationally
known St. Jude Children’s Research Hospital in Memphis in 1998 and 1999, as
researchers tried to improve the five-year ”cure rate” for acute
lymphoblastic leukemia, normally one of the most treatable forms of the blood
cancer.

The children, whom the hospital declined to identify, died of infections or
seizures apparently caused by the first phase of the multifaceted drug and
radiation experiment, according to Dr. William Evans, the hospital’s
executive vice president. The death rate in the first phase of the trial,
three of 53 children, was double the usual rate.

Inspectors with the federal research protection office, acting on a
complaint, faulted the hospital for failing to report the deaths promptly
both to the government and to the hospital’s ethical review board, so they
could decide if other children’s lives were at risk.

An independent review, required by the government, later concluded that the
hospital did not unjustifiably delay reporting the deaths and tried to adjust
the experiment to make it safer. Nonetheless, with the deaths still
unexplained, the hospital abandoned the study and agreed to hire an ombudsman
for patients in future studies.

”We have since modified the treatment and had no problems,” said the lead
researcher, Dr. Ching-Hon Pui, who declined to talk in detail about what
happened, saying, ”I still feel bad and I don’t want to refresh my memory.”

Even when cancer researchers know that an experiment may increase the child’s
risk of death, it’s not clear that they always fully inform the children or
their parents.

Two children died suddenly and two more suffered life-threatening infections
in the first phase of a leukemia experiment conducted in 2000 – nine years
after researchers at Dana-Farber Cancer Institute in Boston warned of an
unusually high rate of death and infection in similar chemotherapy.

Among the first 32 children enrolled in the Pediatric Oncology Group study at
sites across the United States, Canada, and Europe, a 10-year-old girl died
from a fungal infection and a 5-year-old girl succumbed to a septic
infection. In addition, a 12-year-old went into shock and a 19-month-old
suffered a brain inflammation, according to a study report.

Researchers at Dana-Farber had warned about just such a tragedy from using
the same drug, dexamethasone, in a four-drug combination during the first
stage of treatment for acute lymphoblastic leukemia. ”The toxicity
associated with dexamethasone used during induction therapy outweighed its
potential benefits,” the Dana-Farber researchers wrote in the journal Cancer
last April, spelling out their earlier warning.

But doctors at the Pediatric Oncology Group, with the approval of the
National Cancer Institute, believed that a change in an antibiotic prescribed
along with dexamethasone would prevent a recurrence of the toxic reactions in
Boston.

Looking back, Dr. William Bowman, the study chairman, said he wasn’t sure
whether the children and their parents were told of the specific risk
suggested by the Boston study. They were warned, he said, about the usual
risk of death during the induction phase for this type of leukemia – about 2
percent. In this case, the death rate was three times higher.

Ultimately, the Pediatric Oncology Group substituted another drug for the
dexamethasone in the first phase. ”We didn’t want to take the risk any
longer,” Bowman said.

Today, other researchers are reluctant to criticize Bowman’s team, since
dexamethasone shows such promise against cancer. ”Part of our task is to
fine-tune how we use these drugs in an attempt to improve outcomes. Sometimes
very small changes have adverse outcomes and sometimes they have positive
outcomes,” said Dr. Stephen E. Sallan, chief of staff at Dana-Farber.

But Boston University medical ethicist Leonard Glantz said the doctors should
have spelled out the risks and alternatives for the parents. ”Certainly
parents should be told when you have a responsible medical authority who
thinks the risks of a particular regime are especially high. It appears there
were some alternatives that reasonable scientists would argue were less risky
for the children.”

There is strong reason to believe that deaths and injuries in research
involving children are more widespread than what is reported to government
offices that handle complaints. For one thing, parents of children with
serious diseases often see drug trials as their best option and are less
likely to complain later if something goes wrong. In addition, many parents
erroneously believe signing a consent form detailing the risks of the
experiment means giving up their right to a remedy.

”They think if something negative happened, `Well, I accepted it and I have
nothing to complain about,”’ said Abbey Meyers, president of the National
Organization for Rare Disorders, a patient advocacy group.

Adding to the difficulty of assessing the scope of research injuries, neither
drug companies nor the FDA typically release information about problems in
drug trials, unless the drug is approved. And even after approval, the FDA
drags its feet in releasing details of the trials. Moreover, there is no
national effort to track the testing of children or any central review of the
reports of side effects.

”It’s likely we wouldn’t be aware of it unless a patient or their parents
brought it to public attention or there was an investigation by [the US
Department of] Health and Human Services. Things could happen very easily and
no one would know about it,” said Dr. Ralph E. Kauffman, director of
research at Children’s Mercy Hospital in Kansas City, Mo., and a leader of
the movement to test drugs in children.

Kauffman, like many researchers, believes that the new testing program is
much safer than the current system in which doctors prescribe drugs without
knowing their effects. ”The risk to a child in a well-run clinical study is
much less than the risk of a child receiving that drug in a doctor’s office
without specific information on dosing,” he said.

For instance, the antibiotic chloramphenicol was widely used for infections
in premature infants until a study in 1959 discovered that babies were unable
to metabolize the drug and it was killing them. The drug had only been
approved for use in adults for infections resistant to penicillin.

Such problems led the American Academy of Pediatrics to campaign for testing
of drugs in children in the late 1970s. But drug companies resisted, citing
the difficulties of finding qualified researchers and parents willing to
volunteer their children as well as the legal liabilities. While a few
companies pursued the pediatric drug market, many saw no financial reason to
do so since drugs approved for adults could be legally prescribed to children.

But an act of Congress in 1997, giving companies financial incentives to test
drugs in children, has led to a flood of testing. Milne, of Tufts, estimates
600 industry-funded studies are underway, double the number in 1997.

The initiative has spurred the creation of a testing infrastructure,
including government-supported centers around the country. In New England,
Yale University houses one center, where 10 studies are ongoing. New England
is also home to two other big players in the private sector – Parexel
International of Waltham, a contract research organization that recently
established a pediatric division, and Kelson Pediatric Partners of Hartford,
which says it has developed a network of pediatric researchers with access to
a pool of 120,000 children. Boston’s academic medical centers have seen a
small increase in testing.

So far, there are no indications of abuses of the magnitude of those at the
Fernald State School in Waltham during the 1940s and 1950s when retarded
children were given radiation-spiked cereal in a test sponsored by MIT and
Quaker Oats.

But there are plenty of troubling examples of research that demonstrate weak
oversight of the burgeoning wave of studies.

In the case of Propulsid, the FDA finally took Dr. Orenstein to task for
numerous failings in her study. But its review came five months after Gage
Stevens died.

FDA investigators found she failed to report to her hospital review board a
number of earlier problems resulting from the drugs, including the case of a
baby who had to be hospitalized when he briefly stopped breathing.

In addition, the FDA noted egregious errors in the consent form that the
Stevens family signed, including the incorrect claim that Propulsid had been
approved for use in children and a failure to spell out known risks.

Stewart and her husband, Scott Stevens, filed a wrongful death suit last
September that also accuses

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02/15/2001 – Writing May Be on Wall for Ritalin

Once again I must apologize for sending so much info at once over the next
couple of days. I have been traveling again as I work to educate more and
more areas of the country about these drugs and the articles that I have
needed to get out to you have backed up yet again.

The following is an incredible article once again written by Kelly O’Meara of
Insight Magazine. Kelly has published several very informative articles over
the last year or so educating the public about the drugging of our children.

We will work to keep you updated on all the latest on this class action suit
filed against Ritalin by the attorneys that took on the tobacco giants and
won.

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

http://www.insightmag.com/archive/200010163.shtml
—————————————————————————–

10/16/2000

Writing May Be on Wall for Ritalin
——————————————————————–
By Kelly Patricia O’Meara
omeara@…
——————————————————————–

A lawsuit challenging the validity of the science behind mental
illness and psychotropic drugs will have repercussions for drug makers as
well as for the mental-health establishment.

Hardly a mention was made in the national media concerning the
class-action lawsuit filed in May by the Dallas law firm of Waters and Kraus.
It named the Novartis Pharmaceutical Co. (the maker of the drug Ritalin), the
American Psychiatric Association (APA) and Children and Adults with Attention
Deficit/Hyperactivity Disorder as defendants for conspiring, colluding and
cooperating in promoting the diagnosis of attention-deficit disorder (ADD)
and attention-deficit/hyperactivity disorder (ADHD).

Last week, however, a second lawsuit made a bang when even
bigger guns were rolled out in California and New Jersey to take aim at an
industry that has enjoyed a special relationship with the Clinton/Gore
administration. Indeed it is a relationship which, based on numerous speeches
by the vice president and his wife – who has been the president’s White House
mental-health guru – would continue if Al and Tipper Gore are allowed to make
the White House their new residence on Inauguration Day.

And if the beating the tobacco industry took at the hands
of these attorneys is any indication of what the defendants should
anticipate, the psychiatric community, pharmaceutical industry and
mental-health advocacy groups finally may be called upon to put their science
where their mouths are. Putting aside the legal jargon, what appears to be in
question is the ever-increasing influence of pharmaceutical companies over
public and private mental-health organizations and, ultimately, whether that
influence is responsible for the growing number of “mental illnesses” and the
subsequent increased use of psychotropic drugs.

The class-action lawsuit that was filed last week in
California and New Jersey names Novartis and the APA as defendants for
conspiring to create a market for Ritalin by targeting millions of children
and misdiagnosing them with ADD/ADHD for the strategic purpose of expanding
use of the drug.

Both the APA and Novartis have a great deal at stake
professionally and financially. To fight the claim that children have been
and still are being misdiagnosed with ADD/ADHD, the APA – the nation’s
leading psychiatric professional group – will be required to cough up its
medical and scientific data to support the ADD/ADHD diagnosis. This may be
difficult given the growing number of physicians, scientists and even
psychiatrists who long have argued that the diagnosis of ADD/ADHD is not
based in science – that the diagnosis is a fraud based on subjective
assessments.

Furthermore, should the APA fail to provide the necessary
scientific data, Novartis could be forced by the courts to return to
consumers hundreds of millions, if not billions, of dollars made from the
sale of Ritalin. Even more devastating to Novartis, should it be exposed that
the diagnosis of ADD/ ADHD is scientifically baseless, would be an end to the
prescribing of the drug. This type of judgment could open the industry to
additional lawsuits requiring proof of thousands of alleged mental illnesses.
The reverberations through the pharmaceutical industry could be devastating.

Considering that Ritalin has been in use since the
mid-1950s, one has to wonder how tens of millions of children and adults
could be prescribed a highly addictive drug for more than 40 years without
concrete scientific data to support the diagnosis. According to psychiatrist
Loren Mosher, it isn’t that tough. Mosher is the former chief of the Center
for Studies for Schizophrenia at the National Institute of Mental Health
(NIMH) and author of the definitive book Community Mental Health, A Practical
Guide. Mosher explains that the Ritalin phenomenon comes down to a very
simple theory: “If you tell a lie long enough, it becomes the truth.” Long
aware of infiltration by the pharmaceutical companies into professional
psychiatric organizations, Mosher resigned his membership in the APA with a
stinging 1998 letter in which he wrote:

“The major reason for this action is my belief that I am
actually resigning from the American Psychopharmacological Association.
Luckily, the organization’s true identity requires no change in the acronym.
. At this point in history, in my view, psychiatry has been almost completely
bought out by the drug companies.”

According to Mosher, “The APA receives a huge amount of
money from the pharmaceutical companies through grants, but the most obvious
and obnoxious examples are the two meetings the APA has each year. At both,
the drug houses basically lease 90 percent of the exhibition space and spend
huge sums in giveaway items. They have nearly completely squeezed out the
little guys, and the symposiums that once were dedicated to scientific
reports now have been replaced by the pharmaceutical-industry-sponsored
speakers.”

The National Alliance for the Mentally Ill (NAMI),
explains Mosher, “gets the pharmaceutical money and then says they spend it
on their ‘anti-stigma’ campaign. They say that mental illness is a brain
disease. And it works well for the people who suffer from this to use their
drugs. This is why NAMI is pushing for forced medication. It is an amazing
selling job on the part of NAMI.”

A nonprofit, grass-roots, self-help support and advocacy
organization for people with severe mental illness, NAMI was featured in a
November/ December 1999 Mother Jones article, “An Influential Mental Health
Nonprofit Finds Its ‘Grassroots’ Watered by Pharmaceutical Millions,” by Ken
Silverstein. The article focused on the enormous amount of funding which NAMI
receives from pharmaceutical companies, with Eli Lilly and Co. taking the
lead by donating nearly $3 million to NAMI between 1996 and 1999. In fact,
according to Silverstein, NAMI took in a little more than $11 million from 18
drug companies for that period. Nonetheless, NAMI, Eli Lilly and the others
deny any conflict of interest.

While Eli Lilly, manufacturer of Prozac, admits making
substantial contributions to NAMI and the National Mental Health Association
(NMHA), it claims that for “proprietary reasons” it is unable to provide a
list of specific contributions. According to Jeff Newton and Blair Austin,
spokesmen for the company, “The key issue here is that these are unrestricted
grants. The groups can use the money any way they want. Lilly’s support of
these initiatives presents no conflict of interest since they represent
efforts to raise public awareness around issues that Lilly publicly
supports.”

According to Bob Carolla, director of Media Relations for
NAMI, “We represent a constituency that uses their [pharmaceutical] products.
Why shouldn’t they give us money? They’re making money off of our members and
some of it has to go back into the community to help us get better
mental-health programs to help people. Much of what we do has nothing to do
with the pharmaceutical industry. We do not advocate or endorse any specific
medications or products, but we also are not going to back off from saying
that millions of Americans lead productive lives because of the medications
they are prescribed.”

Meanwhile, NAMI has no problem stating that “mental
illnesses are disorders of the brain.” In fact, according to Carolla, NAMI
“has been trying to educate people that mental illnesses are a result of
brain disorders and they are treatable. Stigmas still exist and stigmas need
to be overcome.” Asked to provide scientific data that mental illness is a
disease of the brain, Carolla deferred to a higher authority explaining that
“this [question] reminds me that one small interest group denies that mental
illness even exists.”

Carolla added, “Mental illnesses are biological brain
disorders. Go read the dominant body of medical information out there. It is
a function of biochemistry. I encourage you and recommend you talk to the
surgeon-general’s office.”
Carolla was referring to the Report on Mental Health
released by the U.S. surgeon general in December 1999, which he says “stands
as the national baseline.” This enormous document goes into great detail
about mental health in the United States. But it does not provide a single
piece of scientific data supporting the claim that even one mental illness is
caused by a brain disease. In fact, what it says is “the body of this report
is a summary of an extensive review of the scientific literature, and of
consultations with mental-health-care providers and consumers. Contributors
guided by the Office of the Surgeon General examined more than 3,000 research
articles and other materials. .”

According to the report, “The review of research supports
two main findings: 1) the efficacy of mental-health treatments is well
documented, and 2) a range of treatments exists for most mental disorders.”

Voilà! The review of research came up with findings about
treatments, not with scientific causes of mental disorders. And there even
appears to be some question about the validity of the treatments.

The surgeon general nonetheless places Ritalin in a
category where the “efficacy of mental-health treatments is well-documented,”
when in Chapter 3 of his report he writes that “because the symptoms of ADHD
respond well to treatment with stimulants,” and because stimulants increase
the availability of the neurotransmitter dopa-mine, the “dopamine hypothesis”
has “gained a wide following.”

The surgeon general may want to review the Drug
Enforcement Administration’s (DEA) 1995 report on methylphenidate, which
makes clear that Ritalin has the same effect on children and adults with ADHD
as it does upon those not diagnosed with ADHD. According to the report:

“There is a considerable body of literature on the
short-term efficacy of stimulant pharmacotherapy on the symptoms of ADHD.
From 60 to 90 percent of children have been judged as positive drug
responders to methyl-phenidate medication. However, contrary to popular
belief, stimulants like methylphenidate will affect normal children and
adults in the same manner they affect ADHD children. Behavioral or
attentional improvements with methylphenidate treatment therefore are not
diagnostic criteria of ADHD.”

NAMI, however, is not the only group apparently being
misled by the surgeon general’s report. Take, for instance, the Mental Health
Early Intervention, Treatment, and Prevention Act (S2639), a broad piece of
federal mental-health legislation sponsored by Sens. Pete Domenici, R-N.M.,
Ted Kennedy, D-Mass., and Paul Wellstone, D-Minn. According to one staffer
familiar with the legislation, Domenici’s staff took the lead in writing it.
The first of Congress’ “findings” states that “almost 3 percent of the adult
population, or 5 million individuals in the United States, suffer from a
severe and persistent mental illness.” When asked where Domenici got these
figures, the same source explained that “the numbers come from various
federal agencies, various studies that have been conducted and the surgeon
general’s report. The senator takes into consideration that there are those
who argue there is no such thing as a medically diagnosable mental illness
but, when someone like Dr. Steven Hyman [director of NIMH] shows a brain with
schizophrenia and one without, then the senator takes it seriously. Hyman is
well-respected.”

While it appears that Hyman’s “brain” slide show has wowed
a great many people, the fact is that even Hyman has contradicted his own
presentation. For instance, as Hyman explained in a Feb. 28, 1999, New York
Times Magazine article, “indiscriminate use of MRI and PET scans . as a
high-tech form of phrenology . are pretty but inconsequential pictures of the
brain.” While Domenici may place a great deal of trust in the “science”
presented by doctors such as Hyman, he also has a more personal interest much
closer to home: His wife served on NAMI’s board for nearly three years.
Domenici’s office did not respond to inquiries about whether the senator had
received campaign contributions from pharmaceutical companies.

NAMI’s Carolla openly admits that NAMI worked with the
sponsors of the legislation, and one doesn’t have to look too hard to see the
similarities between the Senate bill and NAMI’s proposed Omnibus Mental
Illness Recovery Act, which Eli Lilly paid to print.

NAMI fully supports the Senate bill, which features such
programs and expenditures as Section 581 in which $75 million would be
appropriated to fund an anti-stigma advertising campaign – which many argue
is a promotion for the pharmaceutical industry and should not be funded with
taxpayer dollars. In question also is why taxpayers should be burdened with
funding an anti-stigma campaign which many believe was created by the
mental-health community when it first began labeling individuals as
defective.

Section 582 would provide $50 million in training grants
for teachers and emergency-services personnel to recognize (read: diagnose)
symptoms of childhood and adolescent mental disorders. This would allow
service personnel such as firefighters, police officers and teachers to make
referrals for mental-health treatment – a difficult task given that each of
these categories of personnel appears to have its hands full with jobs for
which they already are trained.

Section 583 would provide another $50 million for
emergency mental-health centers within which mobile crisis-intervention teams
would be established. This would allow for the designation of a central
receiving point in the community for individuals who may be cited by, say, a
firefighter, to be in need of emergency mental-health services. And this is
just the beginning of the programs proposed under the Mental Health Early
Intervention, Treatment, and Prevention Act, now pending in Congress.

Larry Sasich, a pharmacologist who handles Food and Drug
Administration drug-safety issues for the Washington-based Public Citizen’s
Health Research Group, tells Insight that “conflicts of interest are kind of
a fact of life in the scientific community. At some point groups like NAMI
are going to have to pay the piper – they’re going to have to answer for what
they are promoting. But it’s hard to tell how much influence the
pharmaceutical companies have. It could be subtle or overt influence
depending on what they want.”

One thing that is certain, concludes Sasich: “The group that is
paying the money wields the big stick.”

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