Fwd: [SSRI-Research] Drug report barred by FDA Scientistantidepressants to suicide in kids

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[sSRI-Research] Drug report barred by FDA Scientist links

antidepressants to suicide in kids

 

 

www.sfgate.com

 

Drug report barred by FDA

Scientist links antidepressants to suicide in kids

 

Rob Waters, Special to The Chronicle

Sunday, February 1, 2004

©2004 San Francisco Chronicle | Feedback | FAQ

 

 

URL: sfgate.com/article.cgi?

file==/chronicle/archive/2004/02/01/MNGB64MJSP1.DTL

 

 

A scientist at the Food and Drug Administration has been barred from

publicly presenting his finding that several leading antidepressants

may increase the risk of suicidal behaviors among children, according

to sources inside the FDA.

 

FDA medical officer Andrew Mosholder was to present his report Monday

at an FDA advisory hearing in Washington that promises to be a

contentious affair involving competing medical experts and parents

whose children took their own lives while on the medications.

 

A senior FDA official said the study wouldn't be presented because it

wasn't " finalized. " But critics fear that the agency's action

indicates it is not prepared to take stronger action against the

drugs, despite warnings about their possible effects on children.

 

Mosholder had been asked by the agency to perform a safety analysis

of antidepressants after reports emerged this summer of high rates of

suicidal behavior among children enrolled in clinical trials for

Paxil, Effexor and other antidepressants.

 

Mosholder, a child psychiatrist, reviewed data from 20 clinical

trials involving more than 4,100 children and eight different

antidepressants. His preliminary analysis, according to two FDA

sources familiar with the report's contents, concluded that there was

an increased risk of suicidal behavior among children being treated

for depression with Paxil and several other antidepressants.

 

An initial agenda for Monday's hearing listed Mosholder and his

findings, but his presentation was removed from a revised agenda, and

Mosholder was told that he could not present his findings at the

hearing, one FDA official, who wished to remain anonymous, told The

Chronicle.

 

According to the official, in early January, Russell Katz, director

of the division of neuropharmacological drug products, called

Mosholder in for a meeting. " He told him that he was sorry, but he

wasn't going to be able to present (his report) because he had

reached a conclusion and therefore was biased, " the official said.

 

Mosholder declined several requests to be interviewed and was not

made available despite repeated requests to FDA's press office. Katz

was unavailable to comment on the charges.

 

In a telephone interview Friday with The Chronicle, Anne Trontell,

deputy director of the agency's Office of Drug Safety, who is

Mosholder's direct supervisor, said the analysis would not be

presented because it had not yet been approved within her office.

 

" The consult on that is not finalized. It's not a final document

within the Office of Drug Safety, " Trontell said.

 

However, Trontell said that at Monday's hearing, Mosholder would

provide a rundown of reports of suicidal behavior received by the

agency from doctors and other professionals.

 

While Mosholder's safety analysis report may eventually be completed

and made public, some FDA insiders fear that withholding it from

Monday's hearing indicates that the agency may be siding with the

pharmaceutical industry in its long-running battle with critics of

antidepressants.

 

" Why is the agency sitting on its hands and acting as if there isn't

a risk when their own scientists have looked at the data and

concluded that there is? " one FDA official remarked.

 

The use of antidepressants and other psychiatric medication among

children has more than tripled in recent years and now approaches

adult usage rates, according to a January 2003 study in the Archives

of Pediatric and Adolescent Medicine. Study author Julie Zito, an

associate professor of pharmacy and medicine at the University of

Maryland, estimates that more than 1 million American children used

antidepressants in 2000.

 

Advocates of the drugs argue that they are imperfect but necessary

weapons against a rising tide of mental illness among children.

 

Last month, a task force of the American College of

Neuropsychopharmacology released its own preliminary review of

published studies on antidepressants and suicide and stated it found

no statistically significant increase in suicide attempts among

children taking the drugs.

 

" The most likely explanation for the episodes of attempted suicide

while taking SSRIs (selective serotonin reuptake inhibitors) is the

underlying depression, not the SSRIs, " said Graham Emslie, a child

psychiatrist and researcher at the University of Texas Southwestern

Medical Center in Dallas.

 

But critics, including consumer advocates and mental health

professionals contend, based on other studies, that the drugs are

often ineffective and sometimes dangerous and that the FDA has failed

to vigorously investigate the risks and protect children's safety.

 

" The FDA is shielding the industry, " said Vera Sharav, president of

the Alliance for Human Research Protection, a consumer advocacy

group.

 

Mosholder's analysis appears to be similar to the conclusions reached

by British regulators, who told doctors in December to stop

prescribing Paxil, Zoloft, Effexor and three other antidepressants to

children because of an apparent " increased rate of self-harm and

suicidal thoughts. "

 

British regulators took action against Paxil in early June after new

data presented to U.S. and British authorities showed that children

taking the drug were nearly three times as likely to consider or

attempt suicide as children taking placebos.

 

Later that month, the FDA issued a similar warning, urging doctors

not to prescribe Paxil to children and announced that it would

conduct a detailed review of pediatric trials of Paxil. The review

was subsequently broadened to include seven other antidepressants,

including top sellers Prozac, Zoloft and Effexor.

 

In October, the agency wrote to physicians to " call to (their)

attention " reports of suicide among children in antidepressant

trials. The agency did not, however, urge doctors to stop prescribing

the drugs.

 

Several current and former FDA staff members interviewed by The

Chronicle said the dispute over Mosholder's report highlights a lack

of assertiveness within the agency over safety issues. They spoke of

a split between the Office of Drug Safety -- Mosholder's office --

and the FDA's drug-reviewing divisions.

 

As an example, they cite a hearing last March on a rheumatoid

arthritis drug, Arava, which had generated numerous reports of

adverse effects, including nine deaths, after being approved by the

FDA.

 

Members of the Office of Drug Safety, who had prepared a 37-page

safety report, were present at the hearing but were not allowed to

speak. A representative of the FDA division that originally approved

the drug, along with the pharmaceutical company that makes the drug,

did most of the talking.

 

A documentary crew from the PBS series Frontline filmed the meeting

and afterward, in the hallway, caught up with David Graham, a senior

epidemiologist with the Office of Drug Safety. The producers had been

denied previous requests to interview Graham, but the government

scientist gave a brief interview without permission.

 

" We had a different perspective, and we really weren't given an

opportunity to present our side of the story, " Graham, on camera,

told the producers. " And the people who did present, the reviewing

division and the company, you know, they didn't see a problem. This

was a very hostile process. And let's just leave it at that. "

 

Paul Stolley, a professor and former chairman of the department of

epidemiology at the University of Maryland, spent a sabbatical year

as a senior consultant in the Office of Drug Safety in 2000 and 2001.

While there, he recalls, he tussled with agency managers over the

safety of Lotronex, a drug used to treat irritable bowel syndrome, a

chronic but usually not serious disease.

 

Stolley said his investigation uncovered high rates of negative side

effects, including a number of deaths, among patients using the drug

and led the company to withdraw the drug from the market.

 

A few months later, over Stolley's objections, the agency allowed the

drug back on the market with a " risk management " program aimed at

educating patients and doctors about the drug's risks. Stolley said

he was excluded from internal FDA meetings on the issue.

 

" I'm worried about the agency, " he says. " I didn't expect people to

think I was right just because I was very senior. What I did expect

was a vigorous debate and instead of having a vigorous debate, they

made a policy decision and then excluded me. "

 

Rob Waters' article, " A Suicide Side Effect? What parents aren't

being told about their kids' antidepressants, " appeared in the Jan. 4

edition of The Chronicle Magazine. E-mail him at robw001.

 

©2004 San Francisco Chronicle

 

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