4/26/2001 – Part 2 – Luvox study on anxiety

http://www.washingtonpost.com/ac2/wp-dyn/A2512-2001Apr25?language=printer

Drug Found to Curb Kids’ Debilitating Social Anxiety

By Shankar Vedantam
Washington Post Staff Writer
Thursday, April 26, 2001; Page A01

Children who are so shy or so attached to their parents that they are afraid
to go to school or sleep alone do much better when given a psychiatric drug,
according to a major study with profound — and controversial —
ramifications for millions of children.

The study of 128 children ages 6 to 17 found that the drug Luvox, widely
prescribed for adults with depression, alleviated the debilitating symptoms
of social phobia, separation anxiety and generalized anxiety — psychiatric
illnesses that afflict as many as 1 in 10 U.S. children.

The effects of the medicine were dramatic, but experts were divided about its
appropriateness: The medicine can help children with severe emotional
problems, but it might also be abused as a chemical quick fix for normal
anxiousness, with lasting effects on growing brains.

“Although the results seem impressive, they nevertheless raise some very
important questions about the use of psychotropic medications in children,”
said Joseph Coyle, chairman of psychiatry at Harvard Medical School, in an
article accompanying the findings in today’s New England Journal of Medicine.

“Any drug that is effective is not going to be innocuous,” he said in an
interview. Children and adolescents diagnosed with these disorders should
first try a form of therapy known as cognitive behavioral therapy, and turn
to medication only if that fails, he said.

An estimated 575,000 children nationwide were diagnosed with anxiety
disorders in the 12 months ending in March, including 136,000 under age 10.
Doctors recommended 390,000 children be put on medicines such as Zoloft,
Paxil and Prozac. Of these, 89,000 were under age 10, according to IMS
Health, a private company that tracks the pharmaceutical industry.

Such vast numbers leave critics aghast. Too many children are being put on
powerful brain-altering drugs for behaviors that may be merely troublesome,
critics say. But other experts point out that many children suffer from
distress that, left untreated, can cause impairment well into adulthood.

“Researchers found that anxiety was among the most common problems that kids
have,” said Daniel Pine of the National Institute of Mental Health. He led
the study. “When researchers follow children with anxiety over time,
sometimes anxiety developed into more chronic problems. It could be the
harbinger of problems with depression, panic attacks and all different kinds
of problems.”

The study, the first large, well-designed survey to examine the effectiveness
of a psychiatric drug for a wide range of anxiety disorders in children, was
partly funded by the National Institute of Mental Health and by Solvay
Pharmaceuticals, which sells Luvox. The drug, which like Prozac increases
levels of the brain chemical serotonin, has been approved for the treatment
of obsessive compulsive disorder in children. Luvox sales were more than $2
billion in the United States last year, according to IMS Health.

Scientists at Johns Hopkins University, Columbia University, New York
University, Duke University and the University of California at Los Angeles
studied the drug over eight weeks in children with anxiety disorders.

An example of a child with severe social phobia would be one who refused to
go to school for two weeks, said Mark Riddle of the Johns Hopkins University
School of Medicine, one of the study’s authors. A milder example, he said,
would be a child who went to school and participated in clubs and group
events, but with intense discomfort.

Extreme separation anxiety disorder, he said, would be displayed in a child
who avoided birthday parties and sleepovers. A medium-grade example would be
children who refused to sleep in their own rooms and wanted to get into bed
with their parents.

Generalized anxiety disorder, Riddle said, were “the worrywarts.”

“A lot of it would be about performance — getting very preoccupied with a
test at school, a lot of fussing about day-to-day things,” he said.

“We don’t want a Prozac nation,” he said about the medication of children.
“We want to make sure we are not doing anything to harm youngsters. On the
other hand, it can be a huge disservice to children to minimize the true
significance of psychiatric impairments that do require treatments. It’s the
latter that can get lost in the very easy and popular position to take, which
is ‘Don’t drug our kids.’ ”

Richard Harding, president-elect of the American Psychiatric Association,
said clinicians should carefully evaluate anxious children to find out
whether their fears are caused by an underlying personality problem — which
would merit psychotherapy or medication — or by a social problem, such as a
bully in school or child abuse at home, in which case medication would be
inappropriate.

“A good clinician will not commit a child to a life sentence on medicine,”
said Riddle. “A good clinician will look to stop medication after the
youngster has had a chance to regroup. You want to work with a clinician who
says we are going to get John off this medication.”

It is unclear what impact this study will have in clinical practice, where
doctors are prescribing children such medicines “off-label” — meaning they
have not been approved for such uses by the Food and Drug Administration.

“Given our current medical-economic system in practice, I suspect both
doctors and parents will be strongly attracted to the quick-fix nature of
this intervention,” said Lawrence Diller, a behavioral pediatrician in Walnut
Creek, Calif., and the author of “Running on Ritalin.”

“We have highly effective psychosocial interventions for these problems,” he
said. But “they are more expensive and take longer.”

He said that helping families come up with parenting strategies could ease
children’s anxieties. “Children are highly responsive to their environments,
and the home is the practice arena to deal with life,” he said. “This is not
parent-blaming — children are difficult to raise. But when the parent makes
changes, you see very rapid changes in the child.”

“It doesn’t negate the value of the medications,” he added. But “with
uncertainty on both sides, effective psychosocial treatments — first do no
harm — take preference.”

More extreme critics, such as Bethesda psychiatrist Peter Breggin, said the
study was produced by scientists who are part of an “old boys’ network of
drug pushers.” He said the psychiatric drugs cause harm — some data have
shown that the drugs cause lasting alterations in the brains of young animals.

Researchers involved in the new study said the drug was well tolerated and
safe.

© 2001 The Washington Post Company

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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……

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