Fwd: [SSRI-Research] Child psychiatrist says never again to industry contracts that suppress negative findings

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JustSayNo

Tue, 17 Feb 2004 22:33:24 -0500

[sSRI-Research] Child psychiatrist says " never again " to industry

contracts that suppress negative findings

 

Martin Keller MD; Xavier Castellanos; Harold Koplewicz; Benedetto Vitiello

MD; James Scully MD; Joseph Biederman; Judith Rapoport MD; Nancy Andreasen;

Marcia Kraft Goin MD. PhD; Graham Emslie MD

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

 

Promoting openness and full disclosure

 

http://www.ahrp.org

 

FYI

 

The Canadian Medical Association Journal (CMAJ)has stepped up to the plate and

put the controversy surrounding the risk / benefit of prescribing

antidepressants in children. CMAJ is examining the facts about the value and

safety of antidepressants, as opposed to the contrived positive spin that has

infiltrated most peer-reviewed reports in journals.

 

An article in CMAJ followed by an editorial, and commentary by Dr. Jane Garland,

a child psychiatrist who heads the mood and anxiety disorders clinic at the

British Columbia Children's Hospital--focus on the suppression of information

about clinical trial failures and the deceptive practices by pharmaceutical

industry giants who control all the information and selectively determine what

gets published, what does not. Selective reporting of data undermines the

scientific integrity of those reports.

 

Drug manufacturers are denying treating physicians access to vital information

about the drugs they prescribe for children and adolescents. Dr. Garland

revealed that in her role as a researcher she saw negative results from trials

on paroxetine [Paxil] but was barred from discussing them for 10 years by

non-disclosure contracts.

 

Dr. Garland said much of the data that is just coming to light showing that

SSRIs are ineffective - and potentially harmful - in a large portion of children

have been suppressed for years.

 

" Some of it is more than five years old. So it's been sitting there not

informing the scientists who are making the recommendations to the general

physicians out there, " she said from Vancouver. " It's a real concern. Because

when you've got selective release of information, it distorts the science,

really, doesn't it? "

 

The Alliance for Human Research Protection applauds Dr. Garland for coming forth

with the truth and for her decision " never again [to] do an industry-funded

trial " under a non-disclosure contract. If other psychiatrists would step forth

and do the right thing, much of the current problems might be resolved--and

children would no longer be at risk of becoming casualties of harmful drug

effects.

 

Industry's suppression of failed studies and industry's manipulation of what

gets published is best demonstrated in an internal, previously " confidential "

SmithBeecham (now GlaxoSmithKline). The 1998 memo, " Seroxat / Paxil Adolescent

Depression Position piece on phase III clinical studies, " was prepared by the

company's Central Medical Affairs team (CMAt) in an effort to contain the

damaging evidence (from the company's own clinical

 

trials) that Seroxat /Paxil failed to work and that adolescents prescribed Paxil

were at increased risk of becoming suicidal.

 

This document was first obtained by the British Broadcasting Company--PANORAMA.

It has also been cited by the (UK) Guardian, the Canadian Medical Association

Journal, and is available on the AHRP website. See: What GSK really thinks about

Paxil for Children at: http://www.ahrp.org/risks/SSRI0204/GSKpaxil/pg1.html

 

 

 

Contact: Vera Hassner Sharav

 

Tel: 212-595-8974

 

e-mail: veracare

 

 

 

http://www.canada.com/health/story.html?id==095D50-C188-4459-BC50-A571C361D

 

130

 

Tuesday » February 17 » 2004

 

Canadian Press

 

Suppressed data from negative drug trials distorts

 

science: Journal

 

HELEN BRANSWELL

 

TORONTO (CP) - Pharmaceutical companies " deceive " doctors and their patients -

and perhaps their shareholders - when they withhold unfavourable data on

prescription medicines, the Canadian Medical Association Journal argues in an

editorial Tuesday. The editorial was part of a package of articles looking at

the suppression of trial data, with a particular focus on testing of

antidepressant drugs in children and teenagers.

 

Concern has been rising for some time about how safe antidepressants called

selective serotonin re-uptake inhibitors are when used by children. There is

evidence that SSRIs, as the drugs are called, can induce suicidal thoughts or

actions in a small proportion of people who take them. Several countries,

including Canada, have recently urged renewed caution over the use of SSRIs in

children. Health Canada is striking an expert panel to study worldwide safety

data on the question.

 

In addition to safety concerns, there are questions about whether the drugs

actually work in children. Last week the journal revealed that GlaxoSmithKline

deliberately withheld trial results that showed paroxetine (sold as Paxil) was

no more effective than sugar pills in children. The journal called it the " file

drawer phenomenon " - when clinical trials which don't reflect favourably on a

drug get buried by the company that paid for them. The editorial called these

types of trials a " commercial liability. "

 

" In the regulation of clinical testing of drugs and devices, safety and efficacy

must trump proprietary rights every time, " the editorial board of the journal

says in urging Health Canada to become more demanding of drug companies.

 

In their defence the drug companies insist they have a responsibility to their

shareholders not to reveal information that might give a competitor a leg up.

" Premature disclosure of proprietary information by Merck (or other

 

companies) can result in significant competitive disadvantage and loss of

incentive or reward for new product development, " Dr. Laurence Hirsch,

vice-president of medical communications at Merck Research Laboratories in

Rahway, N.J., argued in one of the commentaries.

 

Hirsch, who was not available for an interview Monday, revealed Merck has

adopted guidelines committing the company to publishing the results of

" hypothesis-testing clinical trials, regardless of outcome, " saying Merck

recognizes the ethical obligation to publish negative data from statistically

sound trials.

 

The journal's view was supported in a commentary by Dr. Jane Garland, a child

psychiatrist who has first-hand experience in the problem. Garland, head of the

mood and anxiety disorders clinic at the British Columbia Children's Hospital,

revealed that in her role as a researcher she saw negative results from trials

on paroxetine but was barred from discussing them for 10 years by non-disclosure

contracts. She told the journal she would never again do a industry-funded trial

under those circumstances.

 

Garland said much of the data that is just coming to light showing that SSRIs

are ineffective - and potentially harmful - in a large portion of children have

been suppressed for years. " Some of it is more than five years old. So it's been

sitting there not informing the scientists who are making the recommendations to

the general physicians out there, " she said from Vancouver. " It's a real

concern. Because when you've got selective release of information, it distorts

the science, really, doesn't it? "

 

Only one of these drugs - fluoxetine or Prozac - has been licensed for use in

children. But doctors frequently prescribe drugs for uses beyond that for which

a drug is licensed. Use of SSRIs among teenagers is increasingly common. Even

preschoolers are occasionally put on the drugs.

 

In fact, there's been a 400 per cent increase in the use of anti-depressants in

children, noted Dr. Michael Rieder, a clinical pharmacologist at the University

of Western Ontario. Rieder believes SSRIs can be safely and effectively used in

some children, under close supervision. But he acknowledged that in some cases,

children on the drugs may not be monitored as closely as they ought to be. " We

need to be careful about what we take, " he said. " And parents need to understand

the drugs their kids take, what they're for, how long you're going to take them

and what you expect out of them. "

 

© Copyright 2004 The Canadian Press

 

http://www.globeandmail.com/servlet/story/RTGAM.20040217.wxdrug0217/BNStory/

 

Front/

 

Globe and Mail

 

Antidepressants found ineffective on teenagers

 

By ROD MICKLEBURGH

 

POSTED AT 5:16 AM EST Tuesday, Feb. 17, 2004

 

VANCOUVER - Widely used antidepressant drugs prescribed to tens of thousands of

Canadian teens and children are barely more effective than placebos in treating

adolescent depression, according to a leading Canadian expert in the field.

 

The assertion by psychiatrist Jane Garland follows a recent cascade of critical

information questioning the risk and effectiveness of prescribing antidepressant

medication for troubled young patients.

 

" The disappointing reality is that antidepressant medications have minimal to no

effectiveness in childhood depression beyond a placebo effect, " Dr. Garland said

in a commentary in Tuesday's Canadian Medical Association Journal.

 

Dr. Garland, head of the Mood and Anxiety Disorders Clinic at Children's

Hospital here, said the lack of evidence showing significant benefits from

adolescent use of the drugs is stunning, given the huge increase in such

prescriptions over the past few years.

 

Seven drugs known as SSRIs (selective serotonin reuptake inhibitors) are under

fire, one of them is well-known Prozac. Although no national figures for

adolescent use are available, in British Columbia, an estimated 6,200 children

and teens were prescribed SSRIs in 2002, more than double the number four years

earlier. All told, nearly 14 million SSRI prescriptions were written for

Canadians of all ages in 2002 and cost $869-million.

 

Drug manufacturers have come under increasing attack for withholding trial

results indicating slight increases in suicidal behaviour, adverse side effects

and only minimal effectiveness of SSRIs in children and teenagers.

 

Several drug tests that came to light last year prompted British authorities in

effect to ban prescription of all SSRIs except Prozac to patients under 18.

 

Two weeks ago, Health Canada issued an advisory to anyone under 18 taking one of

seven antidepressants to consult with their doctors " to confirm that the

benefits still outweigh the potential risk. "

 

In her commentary, Dr. Garland called the situation a crisis in the treatment of

childhood depression, which she said affects one in five Canadians at least

once. She criticized " opinion leaders in child psychiatry " for remaining silent

in the face of escalating data on the relative ineffectiveness of SSRIs. " It is

disturbing. "

 

Dr. Garland cited one study showing that 69 per cent of clinically depressed

young patients improved taking the SSRI drug Zoloft, compared with 59 per cent

who improved taking a placebo. " Essentially, only one in 10 patients receiving

[Zoloft] improved, a result described in the report as 'statistically and

clinically significant' when it is almost certainly clinically meaningless. "

 

She said some trial results indicate SSRIs may help adolescents with anxiety

disorders or particularly severe depression that has resisted other forms of

treatment. " But those with milder, garden-variety depression may be no better

off than with a placebo, " Dr. Garland said yesterday in an interview.

 

She said physicians should inform young patients and their parents that

medication will not cure depression, although it might improve some symptoms.

And they should also be told that psychiatric or behavioural adverse effects are

at least as likely as antidepressant effects, Dr. Garland said.

 

No SSRI has been approved by Health Canada for patients under 18, although the

so-called " off-label " use of medications is common in many areas of treatment.

 

At Children's Hospital, in light of new doubts about antidepressants,

psychiatrists are recommending only two for new patient prescriptions: Prozac

for depression, and Zoloft for obsessive-compulsive disorder.

 

Dr. Marshall Korenblum, chief psychiatrist at the Hincks-Dellcrest Centre for

Children in Toronto, is concerned but unconvinced by recent disclosures

questioning the adolescent use of SSRIs.

 

" We've had 10 years of experience with some of these drugs, and we didn't hear

about them in such negative terms before. "

 

Dr. Korenblum said he has had good results prescribing SSRIs to his young

patients. " A reduction in anxiety. A lifting of depression. Normalization of

sleep and eating habits. "

 

But he agreed more patient monitoring is needed because of the new data. " Some

of the negative tests are alarming and disturbing. . . . I am in favour of

closer monitoring and stiffer warnings. But the evidence is not strong enough

for an outright ban. "

 

 

 

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