June 25

Forest Labs Admits Concealment of data – Congressional Probe Expands

Forest Labs Admits Concealment of data – Congressional Probe Expands

Sat, 26 Jun 2004

New York Times business reporter, Barry Meier, reports, “Forest officials had not told a medical journal about a failed unpublished study in 2002 of Celexa use in children and adolescents, before the journal published an article this month about a separate test indicating the drug could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pharmaceutical companies–e.g., GlaxoSmithKline and Forest–are belatedly bringing forth previously concealed data from unpublished drug trials.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

See: “Conflict probe expands to FDA,” T. Agres, The Scientist, May 19, 2004.
"FDA expands disclosure Review of 1800 outside activity requests ‘cursory,’ key lawmaker says," T. Agres, The Scientist, June 21, 2004.

Contact: Vera Hassner Sharav
Tel: 212-595-8974


June 26, 2004
Drug Maker Acknowledges Some Negative Test Results

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.

June 23, 2004
Democrats Take a Look at Drug Tests

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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