Spitzer Asks Drug Maker for Off-Label Use Material

By BARRY MEIER

Published: August 4, 2004   

Drugs (Pharmaceuticals)

 Suits and Litigation

 Medicine and Health

 Johnson & Johnson Incorporated

Johnson & Johnson said yesterday that the New York attorney general, Eliot Spitzer, had asked for information about six of its drugs, including marketing materials, the results of clinical trials and data on prescriptions for so-called off-label use.

Johnson & Johnson is the third drug company to come under scrutiny from Mr. Spitzer in recent months over its handling of clinical trial data and drug marketing practices. Mr. Spitzer has previously said that he planned to use legal action or the threat of legal action to force greater industry disclosure of clinical trial findings, an issue that has drawn intense public interest.

In June, Mr. Spitzer sued GlaxoSmithKline, saying it had misled doctors by highlighting positive test data for Paxil, its popular antidepressant, while playing down negative results. The company has denied any wrongdoing.

Several weeks later, he asked Forest Laboratories to provide his office with test data and marketing materials about its products, including the antidepressants Celexa and Lexapro.

Johnson & Johnson made the disclosure about the request from Mr. Spitzer in a regular quarterly report filed with the Securities and Exchange Commission.

It identified the drugs at issue as Topamax, an antiseizure medication; Risperdal, an antipsychotic drug; Procit, an anemia medication; Reminyl, an Alzheimer's medication; Remicade, a treatment for rheumatoid arthritis; and Aciphex, a drug to relieve acid reflux.

The prescriptions on which Mr. Spitzer is seeking information are those for off-label uses - or treatments other than the federally approved uses of the medication. While doctors are free to prescribe an approved drug for any use, drug companies are allowed to actively market drugs only for the approved treatment.

The type of informational request received by Johnson & Johnson is not a subpoena. But depending on the findings, such a request can be the first step in a process that could eventually lead to a civil suit. Federal investigations are also under way into several of the drugs at issue in Mr. Spitzer's inquiry, including Topamax, Remicade and Risperdal.

Jeffrey J. Leebaw, a spokesman for Johnson & Johnson, based in New Brunswick, N.J., said that the company "is responding to the request."

Mr. Spitzer is not alone in calling for the greater disclosure of clinical test data. The American Medical Association recently urged Congress to pass legislation requiring drug makers to list all drug trials and their results in a publicly available database. Several leading medical journals are also considering a proposal that would require a trial to be registered in such a database as a prerequisite to subsequent publication of the trial's results - making it less likely that an unsuccessful trial could escape notice.

The drug industry, long criticized for not moving toward fuller disclosure, has scrambled to respond. In June, GlaxoSmithKline said it planned to create a Web site on which it would list most of its trials and their results. Several other companies, including Johnson & Johnson and Merck, have said they supported the concept of a public trial registry.

Yesterday, Eli Lilly disclosed its position on the issue, saying it would soon create a Web site on which it would list the results of clinical tests of approved drugs, including trials of those drugs for new uses. The plan appears to be the most sweeping so far by a drug company.

Lilly's intention to create such a registry was reported yesterday by The Wall Street Journal.

Another Spitzer Suit

ALBANY, Aug. 3 (AP) - The New York attorney general, Eliot Spitzer, and the state's civil service commissioner, Daniel Wall, will announce a lawsuit against a large pharmacy benefit managers on Wednesday, Mr. Spitzer's office said.

The name of the company named in the lawsuit was not disclosed. However, Express Scripts is the only company providing pharmacy benefits to New York's civil service employees, and the company was informed recently of Mr. Spitzer's intent to sue.