[SSRI-Research] Forest Labs Admits Concealment of data-Congressional Probe Expands

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PantsOnFire

Sun, 27 Jun 2004 03:44:21 -0000

[sSRI-Research] Forest Labs Admits Concealment of data-Congressional

Probe Expands

 

[-- gee... now THIS is a surprise...Forest Labs hiding something?! --]

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting openness and full disclosure

http://www.ahrp.org

 

FYI

 

New York Times business reporter, Barry Meier, reports, " Forest

officials had not told a medical journal about a failed unpublished

study in 2002 of Celexa use in children and adolescents, before the

journal published an article this month about a separate test

indicating the drug could help young people. Some of the recent

article's authors were Forest employees. "

 

With NY State Attorney General, Eliot Spitzer, hot on the trail for

fraudulent concealment of clinical trial evidence, and Congressional

probes in both houses demanding original documents from drug

companies, from the FDA, and the NIH, pharmaceutical companies--e.g.,

GlaxoSmithKline and Forest--are belatedly bringing forth previously

concealed data from unpublished drug trials. That concealed data

from antidepressant drug trials in children and adolescents confirm

that these drugs offer children no benefit to justify the risks of

severe adverse drug effects. These findings validate the testimony of

parents whose children suffered, some committed suicide as a result

of these drugs' effects.

 

Faced with public censure, congressional calls for legislation, the

American Medical Association, the American Psychiatric Association,

and the American Academy of Child and Adolescent Psychiatry have

suddenly " seen the light. " The AMA, APA, the AACAP and the NIH, along

with Merck Pharmaceuticals, have come forth in support of a public

registry of clinical trials.

 

Congressional probes into conflicts of interest at the National

Institutes of Health, and the conduct of high ranking FDA officials,

indicate that government officials played a role in helping

pharmaceutical companies to conceal evidence from physicians and the

public. Hopefully, all those involved in concealing data from drug

trials--including pharmaceutical company CEOs, university-based

psychiatrists who reported only the positive test results, as well as

officials of the FDA and NIMH--will have an opportunity to explain

their conduct publicly, under oath.

 

Recent revelations about concealed information from clinical trials

underscore that information reported to the FDA about adverse drug

reactions belongs to the public-it does not belong to government

agencies or private companies.

 

Beyond clinical trial data, the Alliance for Human Research

Protection urges Congress to require the FDA to use MedWatch, FDA's

database for collecting adverse drug reaction (ADR) information from

health care professionals and the public, for the public interest.

ADR reports submitted to the FDA are shared with the World Health

Organization which maintains a worldwide database of ADRs, but this

is not easily available, even to researchers. FDA data on ADRs should

be accessible to the public -as is census data-- without them having

to use cumbersome access methods such requests under the Freedom of

Information Act. ADR reports should be analyzed each semester by the

FDA and the results made public.

 

Just as importantly, the FDA should inform the public about patterns

of reporting adverse drug reactions. It is common knowledge that only

about 5-10% of all serious adverse reactions - including those

resulting in hospitalization or death - are ever reported. Thus, the

FDA should seek advice and suggestions from public health researchers

on devising methods to encourage physicians to report suspected

adverse drug reactions, in the public interest.

 

Finally, the FDA should undertake a public education campaign to

encourage consumers to report adverse drug reactions directly to

MedWatch via the Internet (http://www.fda.gov/medwatch/).

 

 

See: NIH backs disclosure of all drug research By Raja Mishra, Boston

Globe June 25, 2004

http://www.boston.com/business/articles/2004/06/25/nih_backs_disclosur

e_of_a

ll_drug_research/

 

See: " Conflict probe expands to FDA, " T. Agres, The Scientist, May

19, 2004. http://www.biomedcentral.com/news/20040519/03/

 

June 21, 2004 Previous

FDA expands disclosure Review of 1800 outside activity

requests 'cursory,' key lawmaker says | By Ted Agres

 

 

Contact: Vera Hassner Sharav

Tel: 212-595-8974

e-mail: veracare

~~~~~~~~

 

http://www.nytimes.com/2004/06/26/business/26drug.html?

pagewanted=print & posi

tion=

June 26, 2004

Drug Maker Acknowledges Some Negative Test Results

By BARRY MEIER

 

 

Forest Laboratories has said a recently concluded test found that its

antidepressant Lexapro did not help depressed children and

adolescents, an announcement that comes amid the growing controversy

over clinical drug tests. The company's announcement is significant

because Lexapro contains essentially the same active ingredient as

another Forest antidepressant, Celexa, which is widely prescribed for

pediatric use. The company made its announcement late Thursday, when

it also released a second statement addressing how it had handled its

disclosure of results from two trials of Celexa in depressed

children.

 

The New York Times reported Monday that Forest officials had not told

a medical journal about a failed unpublished study in 2002 of Celexa

use in children and adolescents, before the journal published an

article this month about a separate test indicating the drug could

help young people. Some of the recent article's authors were Forest

employees.

In recent weeks, pharmaceutical companies have faced growing pressure

on the issue of selective disclosure of drug test results. The

American Medical Association has called on the federal government to

create a database in which trials can be tracked from start to

finish. And several medical journals are considering a proposal that

would require trials to be registered at the outset as a prerequisite

to the results' eventual publication.

 

Forest's disclosure on Thursday about the negative Lexapro test came

before the initial results were presented at a medical meeting or

published in a journal. Forest had said earlier that it did not point

to the negative Celexa test because there was no published reference

to cite.

 

Forest said that the pediatric test of the drug had been recently

completed and that the company had issued a safety report to the Food

and Drug Administration indicating that Lexapro did not cause an

increase in the test patients' suicidal thinking. Regulators are

concerned that several widely used antidepressants like Celexa might

cause children and adolescents to harm themselves or consider

suicide.

 

In the separate announcement addressing Forest's handling of the two

Celexa tests in depressed young people, the company said, " Given the

current increased interest in industry publication practices as well

as outstanding questions about the role of antidepressants in the

pediatric populations, questions about the availability of these

reports have been raised. "

 

The study with positive findings, which was conducted in this

country, was published in this month's issue of The American Journal

of Psychiatry. The findings of the negative study, which was

conducted in Europe from 1996 to 2002, have never been published nor

were they referred to in the recent journal article.

 

In Thursday's release, Forest said that the company had discussed

both the " topline efficacy results " as well as safety findings from

the failed European study at a meeting of the American Academy of

Child and Adolescent Psychiatry in October 2003. The company did not

elaborate about that presentation, and a Forest official said in an e-

mail message that the company could not respond to questions about

its statement until early next week.

In previous responses to inquiries from The Times, however, Forest

stated that it presented safety data at that meeting, rather than

both safety and efficacy findings. Two outside researchers involved

in the positive Celexa study, also said in recent interviews that

Forest did not tell them about the efficacy findings of the European

study and that they were not independently aware of them.

 

In October 2003, the finding of the European study that Celexa showed

no effects greater than a placebo was noted in a chart published in a

medical textbook written in Danish. The European study was sponsored

by H. Lundbeck, the Danish company that developed citalopram, which

Forest markets in this country as Celexa.

 

Forest officials, who said that they did nothing wrong, also stated

in Thursday's announcement that the European study involved some

hospitalized patients, while the tests in this country involved only

patients treated in clinics or doctor's offices. Both Celexa studies

were reported to regulators, the company said.

 

The company is not currently permitted to promote either Lexapro or

Celaxa as a treatment for depression in young people, although

doctors are free to prescribe the drugs for any purpose. Celexa is

the fourth-leading drug prescribed for pediatric depression. Because

Celexa's patent is about to expire, Forest has been aggressively

marketing Lexapro as a treatment for adult depression. The company

said in its statement that it intended to discuss with federal

regulators its plan to start additional pediatric tests of Lexapro in

the hope of eventually winning approval for such uses.

 

Although Forest's stock fell in after-hours trading Thursday

following the company's announcements, and briefly plunged when the

market opened yesterday, the shares recovered by the end of

yesterday's trading session. They closed at 58.46, up 91 cents. That

is still below their 52-week high of nearly $79 in early March.

 

http://www.nytimes.com/2004/06/23/business/23drug.html?

pagewanted=print & posi

tion=

 

June 23, 2004

Democrats Take a Look at Drug Tests

By BARRY MEIER

 

Two medical groups involved in the issue of the disclosure of

clinical drug trials are expected to meet tomorrow with staff members

of several Democratic senators who may soon introduce legislation

that would require drug makers to divulge the results of tests in a

government-run database.

 

The groups involved in the meeting include the American Psychiatric

Association and the American Academy of Child and Adolescent

Psychiatry, representatives of those organizations said in interviews

yesterday.

 

Both groups belong to the American Medical Association, the nation's

largest doctors' group, which adopted a resolution last week calling

on federal officials to create such a database, which is sometimes

called a trial registry.

Under the proposal, companies would be required to register a test

when it starts and report its results or the reasons it was ended.

 

The three Democratic lawmakers involved are Tim Johnson of South

Dakota, Edward M. Kennedy of Massachusetts and Christopher J. Dodd of

Connecticut, representatives for two of those officials said. One of

those lawmakers, Senator Kennedy, has said he plans to introduce

legislation calling for a federally run trial database.

Representatives for both of the groups and the lawmakers who are

expected to take part in tomorrow's meeting described it as

preliminary. But the move by the three senators, which comes just a

week after the A.M.A.'s adoption of its proposal, suggests that a

Congressional debate over how the drug industry discloses and

presents information about drug trials could soon unfold.

 

Dr. David Fassler, a trustee of the American Psychiatric Association,

said in a phone interview yesterday that the group was interested in

discussing with elected officials how a government-run trial registry

might best work to make sure the information was both complete and

accurate. " We certainly view this as a bipartisan issue, " said Dr.

Fassler, a child psychiatrist in Burlington, Vt., and a co-author of

the A.M.A. resolution. " Physicians and patients need as much

information as possible to make medical decisions. "

 

The debate over clinical trial results has emerged in recent months

after the disclosure that some manufacturers of antidepressants

highlighted positive findings in tests on youngsters for those drugs

while playing down negative or inconclusive ones. Senator Charles E.

Grassley, Republican of Iowa, is playing the lead role in a

Congressional investigation into whether the Food and Drug

Administration suppressed a study by an agency official who thought

that several widely used antidepressants might pose safety risks to

children and adolescents.

 

Yesterday, a spokeswoman for Senator Grassley, who has recently

stated that he also plans to investigate the F.D.A.'s handling of

some other drug tests, said that to date he has not decided whether

to introduce legislation supporting a drug trial registry. A few drug

companies have supported calls for more-comprehensive drug test

disclosure but a unified industry position has yet to emerge.

 

A spokeswoman for the A.M.A. said yesterday that the offices of

several lawmakers have contacted the group in recent days expressing

interest in the registry issue. She added that the A.M.A., which

represents about a third of the country's doctors, thought that a

federal law requiring trial registration was necessary to make such a

database effective.

 

Policy makers said last week that they took the action because of

concerns that drug industry sponsorship of such tests was affecting

quality and because companies, as well as medical journals, tend to

spotlight tests with positive findings compared with those having

negative or inconclusive results.

 

Senator Kennedy has already said that he plans to reintroduce a bill

that would expand, among other things, protections for people taking

part in clinical trials. The Boston Globe reported Saturday that he

now intended to also address the issue of a trial registry in that

bill, though he has yet to formulate any specific proposal.

 

Jim Manley, a spokesman, said he thought that Senator Kennedy had

decided to take the added step after several recent news reports

about trial registries. " The public should have access to the results

of all clinical trials - not just the ones that show favorable

results, " Senator Kennedy said in a statement issued yesterday.

 

Copyright 2004 The New York Times Company

 

 

 

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