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Off-label drug marketing: Missing the mark


Oct 22, 2006 | Mercury News The heart-failure drug Natrecor seemed sure to become a blockbuster after Scios of Fremont put it on the market in 2001.

Besides its use in hospitalized patients, many clinics began giving it to walk-in patients in weekly sessions dubbed ``tuneups.'' Some people including prominent heart specialist Dr. Eric Topol say Scios encouraged this with a hotline and brochure explaining how to bill Medicare for the sessions.

There was only one problem: Some medical experts contend Natrecor was never approved for such tuneups. Some also say it may not be as safe as initially thought.

Scios says studies show the drug is safe. And it has launched a campaign to clarify to doctors that the drug is not recommended for repeated use in patients in a clinic setting.

Nevertheless, the drug's sales have sagged and the company is under investigation by the U.S. attorney in San Francisco for allegedly engaging in ``off-label'' marketing, promoting drugs for uses not approved by the government.

Since this case came to light, critics in two major medical journals have cited Natrecor as an example of how easy it is for drug companies to peddle their medicines for unapproved purposes. Although doctors are allowed to prescribe drugs for off-label treatments, companies are forbidden from promoting their drugs for such uses.

``The system is faulty, and there are numerous leaks in the pipe,'' said Aaron Kesselhelm, one of three Harvard medical specialists who published an article this summer in the journal Health Affairs that criticized the use of Natrecor for tuneups.

But executives at Scios which Johnson & Johnson bought for $2.4 billion in 2003 maintain they and Natrecor have been unfairly tarnished.

Scios spokeswoman Chris Ernst wouldn't comment about the off-label claims, except to say the company is cooperating with the federal probe. But she stressed that ``patients are our first priority'' and noted that 15 studies of Natrecor in people turned up no cause to believe the drug is risky.

Nonetheless, Scios said in June it will do another massive study over the next couple of years to definitively assess Natrecor's safety.

The U.S. Food and Drug Administration approved Natrecor for treating patients with congestive heart failure who have trouble breathing even while doing minimal activity or resting. It has been given to hundreds of thousands of people and its sales hit $395 million in 2004. But since then, the drug has run into trouble.

After reanalyzing past studies of Natrecor, New York heart specialist Dr. Jonathan Sackner-Bernstein published two reports in 2005, warning the drug seemed linked to worrisome rates of kidney problems and death.

In disputing Sackner-Bernstein's conclusions, Scios has reported finding only a slightly increased death rate among those taking Natrecor after 30 days. Moreover, after tracking some Natrecor patients over six months, the company said it found virtually no difference in their death rate compared with patients on other medicine.

Although many patients are given drugs for off-label uses, the practice worries some critics. Doctors often prescribe medicines for purposes not approved by the government based on preliminary studies suggesting they might be effective for such uses. But one expert has said the evidence supporting off-label use is questionable.

A study published in May by Dr. Randall Stafford, an associate professor of medicine at Stanford University, found about 20 percent of the drugs in a national prescription database were given for off-label purposes. And in most of those cases, he determined, there was little or no evidence the drug was effective for those uses.

Companies, on the other hand, can face heavy fines for promoting drugs for off-label purposes. But the FDA's ability to halt abuses is limited, said Dr. Sidney Wolfe, who directs Public Citizen's Health Research Group.

``They do not have anywhere near the budget they should,'' Wolfe said. ``That is a major reason the drug industry is able to get away with what they do.''

FDA and Justice Department officials said they don't track how many companies have been prosecuted for off-label marketing. But Ioana Petrou, chief of major crimes for the U.S. attorney in San Francisco, said federal authorities have been paying increasing attention to such practice, given the grave danger it can pose to the public.

``In the vast majority of the cases prosecuted, there are misleading statements being made to the medical community by the pharmaceutical companies,'' she said. ``So the patients can't rely on their doctors to tell them what is safe and effective.''

Petrou said the first off-label case the Justice Department ever prosecuted involved Protropin, made by Genentech of South San Francisco. Although Protropin was approved for treating children with a growth hormone deficiency, the company was accused of promoting it for healthy short children. Genentech denied the charges, but paid $50 million to settle the case in 1999.

Now Genentech is under investigation for off-label marketing again, this time over Rituxan. In 1997, the FDA approved the drug for treating non-Hodgkin's lymphoma and in February this year also approved its use for rheumatoid arthritis.

It's unclear what the current investigation by the U.S. Attorney in Philadelphia involves. But a lawsuit by a former Genentech employee has accused the firm and its partner, Biogen Idec, of promoting Rituxan for rheumatoid arthritis before it was approved for that purpose.

Genentech spokeswoman Caroline Pecquet said the company is cooperating with prosecutors, who she said are expected to call current and former Genentech employees before a grand jury.

``We are committed to ethical and legal promotional practices,'' Pecquet added.

Yet another Bay Area company accused of off-label marketing is InterMune of Brisbane. In July, its executives announced they had created a $30 million reserve in hopes of settling a federal investigation into claims the firm improperly promoted Actimmune. The drug is approved for treating a bone disorder and a condition that makes people prone to infections. But InterMune also was accused of marketing it as a treatment for lung disease.

InterMune spokeswoman Pam Lord said the probe focuses on former employees.

The marketing of Natrecor has aroused particular concern because of questions about its safety, especially given the claims that people were receiving repeated injections of the drug in tuneups.

Using Natrecor occasionally to treat people in out-patient clinics wouldn't necessarily be considered an off-label use of the drug, said Dr. Norman Stockbridge, who directs an FDA division overseeing heart and kidney drugs. But he said giving such patients frequent doses of Natrecor would be an unapproved use.

Responding to the criticism, Scios convened a panel of medical experts last year to review Natrecor's safety. The group concluded more studies of the drug were warranted. But until then, it recommended that Natrecor should be given only to the seriously ill in hospitals and not in frequent doses to people in outpatient clinics.

Since the Natrecor controversy erupted last year, doctors familiar with the drug say its use has dropped dramatically. That troubles some doctors who swear by Natrecor, also known as nesiritide.

``I am absolutely enthusiastic,'' said Dr. John Luber Jr., a Tacoma, Wa. heart specialist involved in a Scios-sponsored study this year that found Natrecor lessened the likelihood of death among heart surgery patients.

But in the New England Journal of Medicine last year, Topol, former chair of the Cardiovascular Medicine Department at the Cleveland Clinic in Ohio, cited Natrecor as an example of a serious and widespread public health issue.

``We need a tuneup of our procedures to eliminate indiscriminate use of drugs, such as nesiritide, when there is not proper evidence of their safety,'' he warned.

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