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?

598 total views, no views today

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@…

428 total views, 1 views today

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

615 total views, 2 views today

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.”

431 total views, 3 views today

02/15/2001 – RISKING KIDS' HEALTH FOR SAKE OF SCIENCE – AT WHAT COST?

http://www.nypost.com/commentary/23654.htm

RISKING KIDS’ HEALTH FOR SAKE OF SCIENCE

Monday,February 12,2001

By DOUGLAS MONTERO

————————————————————————
AT WHAT COST?
Columbia’s Dr. Laurence Greenhill heads the Ritalin study.
– NYP: Rick Dembow

TWO city research institutions will extend their tentacles into our
communities today, looking for hundreds of kids, some as young as 3, to use
as guinea pigs.

The experiments, to determine the safety and efficacy of Ritalin in
preschoolers, have advocates up in arms – they think researchers are playing
fast and loose with the brains of children.

“Where’s the limit?” asked Dr. Ellen Isaacs, a member of the Coalition
Against the Violence Initiative, a grass-roots group in the Washington
Heights section of Manhattan. “Are they going to give it to kids in the
womb?”

The rationale of the nationwide experiment on the preschoolers seems noble –
Ritalin is already prescribed by doctors like lollipops without any sound
medical evidence to show that it’s safe for a child’s developing brain.

About 2 million kids nationwide, nearly a quarter-million of them between
ages 2 and 4, take Ritalin and other psychiatric drugs, according to a March
2000 report by the Journal of the American Medical Association.

The report inspired then-First Lady Hillary Clinton, who was a candidate for
the U.S. Senate at the time, to prod the White House to look at ways to stop
the alarming trend, and that translates into experiments. Some thought
Clinton’s motives were political, others applauded her.

The National Institute of Mental Health subsequently gave $6 million to a
consortium of six institutions, led by Dr. Laurence Greenhill of Columbia
University, to conduct the Ritalin study. New York University also is part
of the group.

Two-thirds of the more than 300 kids in the nationwide study called
Preschool ADHD Treatment Study (PATS) will be under 6 years old.

They are looking for kids with symptoms of Attention Deficit Hyperactivity
Disorder who have never been medicated.

Members of the coalition two weeks ago protested outside Columbia
Presbyterian Medical Center, which is affiliated with Columbia University,
handing out leaflets alerting parents, schools and community groups.

The coalition is worried researchers will offer money for subjects or give
parents false hopes that their children will be cured. They also worry that
the unknown, long-term side effects of the drugs might harm kids.

Advocates are also wondering how researchers are going to properly diagnose
the preschoolers – some of who can’t express themselves thoroughly.

“Obviously, if it’s the researchers doing the diagnosis, it is in their
interest to diagnose kids with ADHD because they need them for the study,”
said Leonard H. Glantz, a law professor at Boston University and author of a
book on the ethics of researching on children.

“Unlike doctors, researchers don’t have the best interest of the patient in
mind.”

Greenhill said the five-stage, 40-week study has been reviewed and
re-reviewed by five ethics panels “to make sure the rights of the children
and their families’ rights are protected.”

Researchers will seek kids by advertising, by referrals from local doctors
and by sending flyers to private schools – since they are prohibited from
recruiting at public schools, Greenhill said.

The children will be diagnosed by a special group of researchers composed of
up of six institutions, including Johns Hopkins, University of California at
Los Angeles, University of California at Irvine, and Duke, said Greenhill,
who insisted the parents will only be given money to get and from the
hospital.

Greenhill is seeking more than 60 kids whose parents will first receive
training to see if their child’s behavior improves. The second stage
involves low-dose medication that’s later upgraded, Greenhill said.

The fourth stage includes a placebo experiment, where some kids get a sugar
pill. Advocates say children will suffer from withdrawal symptoms because
Ritalin is addictive.

Parents have to sign consent forms for each stage, including the last, which
includes a gradual tapering off or continuation of the drug.

Informed of the study she inspired, Clinton spokeswoman Karen Dunn said,
“Hillary Clinton is very concerned about the increased use of Ritalin in
young children and has strongly supported efforts to determine whether it is
being used appropriately and effectively.”

That sounds politically and morally correct, but the folks in Washington,
D.C., aren’t going to be around to see what becomes of these kids who donate
their brains to science.

374 total views, 1 views today

02/15/2001 – Doctors Say Drug Trial's Approval was Backdated

Pfizer, makers of Zoloft and Viagra cannot seem to stay out of trouble
lately. This is one of several messes they have found themselves caught in
around the world lately. I thought all of you who barely survived your bouts
with Zoloft would be interested.

Not that Pfizer is the only drug company out there doing this type of thing.
They just got caught. I have learned over the last decade of doing research
on these issues that most drug companies would not blink an eye in deciding
to do the same. They are so often caught in such underhanded dealings that I
wonder why they are allowed to continue business.

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

http://www.washingtonpost.com/wp-dyn/articles/A63515-2001Jan15.html

Doctors Say Drug Trial’s Approval was Backdated

THW WASHINGTON POST

By Joe Stephens
Washington Post Staff Writer
Tuesday, January 16, 2001; Page A01

The Nigerian doctor who supervised a 1996 Pfizer Inc. drug experiment on
desperately ill children said in an interview that his office created a
backdated ethics approval document that the American pharmaceutical company
later used to satisfy U.S. regulators and to justify its conduct of the
human testing.

Abdulhamid Isa Dutse, the physician who oversaw the test of the antibiotic
Trovan on children with meningitis, said the letter may have been written as
long as a year after the test was completed when Pfizer officials asked him
for proof the test was reviewed by a Nigerian ethics board. Nigerian
officials are now examining the roles played by Dutse and others in
conducting the American company’s drug trial, which was the subject of an
investigation by The Washington Post.

Pfizer spokesman Andy McCormick said last week that he was unaware of
possible irregularities in the Nigerian ethics approval document. “We are
currently investigating it. We are cooperating with the authorities in
Nigeria,” he said.

The New York-based company gave the letter to the U.S. Food and Drug
Administration in 1997 during an audit of records supporting its application
to use Trovan for treatment of children during a meningitis epidemic. U.S.
regulations require that if a company intends to use foreign medical
research to support a drug application, the experiments must be reviewed and
formally approved in advance by an ethics committee.

FDA officials last week declined to comment on the Pfizer case, but one
official said it is a violation of federal law to knowingly submit false
documents to a government regulatory agency.

Typed on the letterhead of the Aminu Kano Teaching Hospital and dated March
28, 1996 — six days before Pfizer’s experiment began — the letter said the
hospital ethics committee had reviewed the plan to test Trovan on 100
children with meningitis and found the protocol to be “adequate.” The letter
gave permission for the test to proceed.

But Sadiq S. Wali, the hospital’s medical director, recently told The
Washington Post the document was “a lie.” He said the hospital had no ethics
committee at the time Pfizer’s test was underway and did not organize it —
or create the letterhead stationery bearing his name that was used in the
approval letter — until months later.

“The hospital is quite clear: We had no ethical committee,” he said in a
telephone interview.

Reached by telephone in Kano last week, Dutse said it was “possible” that
the approval letter was drafted up to a year after the trial.

Dutse, who was listed as Pfizer’s “principal investigator,” said he felt
that the letter reflected the informal approval he had obtained from three
doctors, who reviewed Pfizer’s test plans and told him they saw no ethical
problems. No records were prepared at the time, he said.

But one of the doctors Dutse cited, Idris Mohammed, last week disputed
Dutse’s account. Reached in London, Mohammed said: “There was no ethical
committee at the time of the trial, none met, and no approval was properly
given for the trial.”

In fact, Mohammed said that he challenged the legality of Pfizer’s
experiment while it was underway and that he demanded unsuccessfully to see
documents proving it had been properly authorized.

“You shouldn’t try an experiment in an epidemic,” said Mohammed, a medical
professor who now heads the Nigerian federal immunization program. “You
needed to give these patients something that was proven.”

Mohammed said that in 1996 he took his concerns to a senior official in the
Nigerian government — then controlled by a military dictator, Gen. Sani
Abacha — but was overruled.

Since the experiment, Pfizer repeatedly has cited the Nigerian committee’s
approval as proof its experiment was ethical. The testing was carried out on
children and infants during a record-breaking meningitis epidemic that
killed more than 15,000 Africans.

The Post’s Dec. 17 article recounted how Pfizer physicians tested the
company’s then-unapproved antibiotic in the impoverished northern Nigerian
state of Kano. The drug was later associated with liver damage and deaths in
the United States and its use was restricted.

Pfizer described the Nigerian test as a humanitarian venture, but medical
specialists and international aid workers attacked it as unethical and
challenged the company’s claim that the children knew they were part of an
experiment.

Pfizer officials have said that the Nigerian ethics committee approved
giving some Nigerian children an oral formulation of the antibiotic instead
of a fast-acting intravenous version used in U.S. meningitis tests.

A Pfizer spokeswoman also said the ethics committee decided there was no
need to warn Nigerian parents that young lab animals given Trovan-class
antibiotics had suffered joint damage. American parents were told of the lab
animal results in a subsequent Trovan trial.

After receiving a copy of the ethics approval letter from The Post, Wali
said he confronted Dutse and the doctor “did admit to me he was wrong,”
although he provided few specifics.

Tim Menakaya, Nigeria’s health minister, said he had appointed a federal
investigative panel charged with determining whether the trial was conducted
legally and, if so, whether the experiment was “morally right.”

“I am investigating all of it,” Menakaya said.

The probe is headed by Abdulsalami Nasidi, a senior health official who said
that he, like Mohammed, considered the experiment to have been unethical in
1996 but failed in attempts to block it.

“It is a very serious problem; procedures were not followed,” Nasidi said.
“We are going to get to the root of the problem.”

Nasidi said that his investigation, whose findings will be forwarded to
Nigerian President Olusegun Obasanjo, failed in initial attempts to locate
“detailed evidence” that Pfizer’s investigators had secured the needed
authorization before launching the experiment. Dutse said he spent two days
last week addressing a closed session of the panel.

The Post’s investigation has generated a flurry of stories in the Nigerian
press, which have reported that “widespread condemnation rages.” Editorials
have called for international investigations, federal lawsuits and criminal
prosecutions.

Nigerian newspapers — always fiery and at times less than entirely
factual — have quoted parents who contend their children had serious
disabilities or died after treatment.

“The government has a duty to tell us whether our children were used as
guinea pigs and, if so, who committed such criminality and who is liable,”
said the Vanguard newspaper.

© 2001 The Washington Post Company

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

Pfizer accused of irregularities during clinical trial in Nigeria

THE GUARDIAN
Sarah Boseley, health editor
Wednesday January 17, 2001

http://www.guardianunlimited.co.uk/international/story/0,3604,423222,00.html

An inquiry is under way in Nigeria into allegations that the multinational
pharmaceuticals company Pfizer used an experimental drug on sick children
during a major outbreak of meningitis, without official approval.
Yesterday the Nigerian doctor employed by Pfizer to run the clinical trial
in Kano said that the letter certifying approval by the ethics committee at
the hospital where the children were treated was probably written a year
after the experiment took place.
Pfizer admitted last night that there did “appear to be possible documentary
irregularities” and said they were co-operating fully with the inquiry.
Pfizer sent a team in to Kano at very short notice in 1996, when it heard of
the outbreak of spinal meningitis. The company wanted to test the efficacy
of its new drug Trovan on children, and such outbreaks in the west are now
relatively rare……

528 total views, 1 views today

1/17/2001 – Upcoming Radio Show & New Site for ICFDA

Mark Miller has spent some long hours developing a whole new look for our
website. He has really done a wonderful job and I want you all to see it. So if
you have not had an opportunity lately to take a look I invite you to check out
the site at www.drugawareness.org The best “Thank you” you can give Mark, or any
of us who are dedicated to bringing you this information, is to pass the web
address out to all you know so that they too can gather the information they
need to save a loved one’s life.

And this coming Sunday (or Monday, depending on what part of the country you are
in) I will the be guest on Art Bell’s Coast to Coast radio program. Ian Punnett
will be the host of the show so it should be good. He and I did a show together
a couple of weeks ago and he is an incredible interviewer. The interview will go
for three hours beginning at 11:00 PM Pacific Time. This is a national program
and is literally heard from coast to coast. To find a station in your area to
listen in or to listen online just go to www.artbell.com. (BTW if you have read
my book, you know that I do not encourage anyone to be awake during those hours
so get a tape ready to record the show and go to bed! 🙂 )

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

427 total views, 1 views today

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

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

More Self Harm Seen with SSRI Therapy Than With Tricyclics

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

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

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

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

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

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

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

458 total views, 1 views today

12/30/2000 – McDermott on Prozac, Paxil AND Deseryl?

If the Boston Herald’s source got it right, McDermott was on one heck of a
combo!!! All three are contraindicated in mixing any of the three with even
one of the others, much less two!! His serotonin levels must have been out of
sight using three serotonergic meds! No one should be surprised that he went
psychotic on this combination, even if the drugs were given in succession,
rather than together.

Let me also point out that the so called “Prozac defense” HAS been used
successfully several times. And as far as I know Kip Kinkle’s attorney never
used the information on the drugs in his murder case.

Prozac would also have been found guilty in a case that is almost identical
this one – that of Joseph Wesbecker in Louisville, KY, who also after being
treated with Prozac went on a shooting spree with an AK47 where he worked.
That is it would have been used successfully if Eli Lilly had not bought off
the plaintiffs in the middle of the trial and then neglected to disclose that
payoff to both the judge and the jurors. Judge John Potter deserves a metal
for taking Lilly and the plaintiffs to court and forcing them to admit the
truth of what happened. Although it took him a couple of years he said that
he did it because he did not want his courtroom turned into an advertising
agency for Prozac and pointed out that this is a public safety issue.
Amazingly Lilly has used that case to defend their drug ever since! (Although
my book discusses the Wesbecker case briefly, the book Power to Harm covers
the Wesbecker case in detail.)

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

“According to the source, who is familiar with the still mounting case,
McDermott had been taking Paxil, Prozac and Desyrel – all of which are SSRIs
designed to treat depression, social phobias or anxiety.”

Source: Suspect was taking drugs for depression

by Dave Wedge, Tom Farmer and Jose Martinez
Friday, December 29, 2000

The hulking computer technician accused of gunning down seven of his
co-workers at a Wakefield high-tech firm this week suffered from a host of
mental illnesses – including schizophrenia – for which he was taking a trio
of antidepressants, a source told the Herald yesterday.

Accused killer Michael M. McDermott at his arraignment Wednesday. (Staff
photo by Matthew West) “He’s got some serious psychological issues and a
long (psychiatric) history,” the source said of 42-year-old Michael
“Mucko” McDermott.

McDermott, a divorced Navy veteran from Marshfield who lived most recently in
Haverhill, suffered from severe depression, paranoia and schizophrenia, and
had been in psychiatric treatment for some time, according to the source who
spoke on condition of anonymity.

To cope with his mental disorders, McDermott was prescribed several Selective
Serotonin Reuptake Inhibitors, or SSRIs, designed to increase brain
serotonin. Low levels of brain serotonin can lead to depression and anxiety
disorders.

A source familiar with the investigation said McDermott’s supervisors at
Edgewater Technology Inc. did not appear to know he was using the medication.

McDermott is being held without bail on seven counts of first-degree murder
in Tuesday’s massacre at Edgewater. Prosecutors have said McDermott wielded a
shotgun and semiautomatic rifle with premeditated precision and extreme
atrocity, hunting down workers in the company’s accounting and human
resources offices but letting others flee unharmed.

He was arrested by police who found him sitting in the lobby near the bodies
of two of his victims. At least two Edgewater employees witnessed the
rampage, including one woman who hid behind a chair and her coat beneath a
desk in the accounting office, where two of her co-workers were killed.

Middlesex County District Attorney Martha Coakley has said McDermott may have
been seeking vengeance over the impending docking of his paychecks by
Edgewater to satisfy an IRS demand for back taxes. Sources say the IRS orders
would have left McDermott with just $275 every two weeks.

But investigators also are looking for clues about what drove the man to kill
by delving into the contents of computers seized from McDermott’s office and
home, where police also found bomb-making literature and materials. One
source said McDermott had attempted to wipe out the hard drive of his office
computer the day of the shootings.

Yesterday, neither Coakley nor McDermott’s defense attorney, Kevin
Reddington, would discuss the case or McDermott’s mental state and
psychological history. However, at Wednesday’s arraignment, Reddington raised
the specter of an insanity defense by saying his client had been seeing
psychiatrists and asking the judge to OK his continued medication.

Insanity defenses rarely succeed. The so-called Prozac defense has been
unsuccessfully attempted in dozens of murder cases nationwide, including in
the case of Kip Kinkel, the teenager who killed his family and two
schoolmates in Springfield, Ore.

According to the source, who is familiar with the still mounting case,
McDermott had been taking Paxil, Prozac and Desyrel – all of which are SSRIs
designed to treat depression, social phobias or anxiety.

The source also said orders have been sent by doctors to the Middlesex County
Sheriff’s office so McDermott can receive his medications in the Cambridge
jail. He will be examined by psychiatrists some time in the next week, the
source said.

The revelations about McDermott’s psychiatric history emerged as his
co-workers returned to St. Joseph’s Church – where so many of them had sought
refuge and solace in the hours after the shootings – for a memorial service
in honor of their seven slain colleagues.

“We’re all hurting and grieving, but I can’t tell you how much we’re pulling
together as a team,” Edgewater Technology Chief Executive Officer Shirley
Singleton said after meeting with her employees for the first time since the
shootings.

The company has started a memorial fund for the families of the slain workers
with a $70,000 donation. Singleton also said grief counseling, which began
yesterday at the firm, would continue as long as employees need help.

She declined to discuss the shootings that claimed the lives of Jennifer
Bragg Capobianco, 29; Janice Hagerty, 46; Louis Javelle, 58; Rose Manfredi,
48; Paul Marceau, 36; Cheryl Troy, 50, and Craig Wood, 29.

State and federal authorities are seeking the origin of McDermott’s weapons,
including the AK-47-style rifle and 12-gauge shotgun that he is alleged to
have used to kill the four women and three men, a .32-caliber pistol found in
his pants pocket and a large-caliber hunting rifle found in a locker by his
desk.

Haverhill police began looking for McDermott late Christmas Eve after someone
reported hearing gunfire in the woods near Crystal Lake, where a man fitting
his description was spotted by a car with the license plate “MUCKO.”
Officers traced the car back to McDermott’s apartment but could not locate
him despite several more visits Christmas Day.

One day later, investigators believe McDermott lugged the weapons unnoticed
into the Harvard Mills complex, one law enforcement source said. Two
soft-sided gun cases were found under his desk.

“He walked them right in and placed them under his desk,” the source said.
“They had a skeleton crew working that day and no one apparently saw him or
recognized what the cases were for.”

The source said McDermott loaded the shotgun with buckshot at his work
station before embarking on his killing spree. The source, a longtime
investigator, said the carnage he witnessed in the shooting’s aftermath left
him shaken.

“I was sick to my stomach over it,” he said. “It was unlike any other
murder scene because it was in a work setting. It was almost surreal. One of
the (dead) women had her head resting on her arm like she knew she was going
to get it.”

Meanwhile, gun control advocates held a rally outside the State House to urge
lawmakers to ban the sale of assault weapons like McDermott’s. Although
Massachusetts already has the country’s toughest gun law, it does not ban the
sale of assault weapons manufactured before September 1994.

“They have no legitimate use in a civilized society other than for law
enforcement,” said Stop Handgun Violence co-founder John E. Rosenthal.

Kevin Sowyrda, spokesman for the Gun Owners Action League, declined to
comment specifically on an assault weapon ban but said, “The last thing we
need in this period of mourning are political rallies.”

Donations may be made to the Edgewater Wakefield Memorial Foundation, Box
2133, Wakefield, Mass. 01880-6133. Donations may also be made at Fleet bank
branches.

Karen E. Crummy contributed to this report.

429 total views, 1 views today