Fwd: Child psychiatrist says never again to industry contracts that suppress negative findings

February 17, 2004

VERACARE <veracare@...> wrote:From: " VERACARE "

" Keller MD " ,

" Xavier Castellanos " ,

" Harold Koplewicz " ,

" Benedetto Vitiello MD " ,

" Scully MD " ,

" ph Biederman " ,

" Judith Rapoport MD " ,

" sen " ,

" Marcia Kraft Goin MD. PhD " ,

" Graham Emslie MD "

Subject: Child psychiatrist says " never again " to industry contracts that

suppress negative findings

Date: Tue, 17 Feb 2004 14:06:52 -0500

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 " Beecham (now GlaxoKline). 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=3D095D50-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

GlaxoKline 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. ce 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. 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. "

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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February 17, 2004