Healthy Skepticism Library item: 476

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Meier B.
Forest Asked to Supply Information on Marketing of Some Drugs
The New York Times 2004 Jun 30

Full text:

Forest Laboratories said yesterday that it had received a wide-ranging request from the New York attorney general, Eliot Spitzer, asking for information about how the company tested and promoted drugs like its antidepressant Celexa for so-called off-label, or as yet-unapproved, uses.
A representative of Mr. Spitzer’s office, who asked not to be identified, said that the request covered 10 products sold by Forest. But that person said that Mr. Spitzer is particularly interested in how Forest tested and promoted two of its antidepressants, Celexa and Lexapro, which are widely used off-label by doctors for the treatment of pediatric depression.

The type of informational request received by Forest is the first step in what could turn into a formal investigation by Mr. Spitzer’s office of the company’s test disclosure and promotional practices or result in a lawsuit against it.

GlaxoSmithKline, the manufacturer of Paxil, another antidepressant widely used to treat children, received a similar request from Mr. Spitzer before his office filed a lawsuit earlier this month accusing it of defrauding doctors by highlighting positive results from some clinical trials of that drug in youngsters while playing down negative ones. The company has denied any wrongdoing.

An executive of Forest, which is based in New York, said no one was available yesterday to comment.

Forest stated that the request from Mr. Spitzer indicated that he believed that the company might have violated New York State law. The company said in its statement that it believed that it had not done anything wrong, adding that it was cooperating with the request.

Because the federal Food and Drug Administration has not approved the use of Celexa or Lexapro for pediatric depression, Forest is legally barred from promoting them for such uses. But doctors are allowed to prescribe drugs off-label where they see fit, and Celexa is the fourth most prescribed medication for pediatric depression.

Mr. Spitzer’s action follows by a week an article in The New York Times which disclosed that Forest did not tell a medical journal about a failed, unpublicized trial of Celexa in children and adolescents when it published an article this month about a positive trial of the same drug in the same types of patients. Some of the article’s authors were Forest employees.

Last Thursday, Forest put out a statement seeking to defuse controversy over how it had handled the disclosure of the failed Celexa trial, which was conducted in Europe from 1996 to 2002. The European study was sponsored by H. Lundbeck, the Danish company that developed citalopram, which Forest markets in this country as Celexa.

At the time, Forest reiterated its position that it had not included any reference to the failed Celexa study in the recent article because there were no published references to it that the article’s authors could cite.
The basic finding of that study – which reported that Celexa showed no effects greater than a placebo – was noted in a chart published in October
2003 in a medical textbook written in Danish.

Forest had publicized the successful trial of Celexa through company news releases as far back as 2001, starting months after the trial was completed and before its data was submitted to a medical journal for consideration.

It was also on Thursday that Forest announced that preliminary results from a clinical trial of Lexapro which showed that it worked no better than a placebo in treating pediatric depression.

That result also may raise questions about the positive Celexa test because Lexapro contains the drug escitalopram, which is the active ingredient found in citalopram, or Celexa.

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.

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.

Also, Mr. Spitzer said in a speech on Monday to health care lawyers that he would continue to investigate how drug companies disclose trial data.