August 9

Johnson & Johnson stung by its own Advisory Committee–Natrecor should be strictly limited

Johnson & Johnson stung by its own Advisory Committee–Natrecor should be strictly limited

Fri, 12 Aug 2005

Kudos go to Dr. Eugene Braunwald and the 10 members of the advisory committee that he heads.

Contrary to Johnson & Johnson expectations, the committee recommended extensive warnings to physicians against prescribing Natrecor to outpatients.

When physicians begin to exercise honest professional judgement– without regard for financial considerations–only then can trust be restored to medicine!

Contact: Vera Hassner Sharav

August 9, 2005
Expert Panel Gives Advice That Surprises a Drug Maker

Call it the advisory committee that keeps on giving advice.

After two medical studies questioned the safety of its popular heart failure therapy Natrecor, the Scios unit of Johnson & Johnson turned in April to a technique government and business often use to make problems go away: it formed an outside advisory committee.

The company appeared to be taken aback in June, though, when it learned just how fiercely independent its committee, led by Dr. Eugene Braunwald of Harvard Medical School, turned out to be.

Rather than the milquetoast findings often returned by such advisory panels, Dr. Braunwald’s committee of 10 medical experts determined that use of Natrecor, an expensive intravenous therapy, should be strictly limited to acutely ill patients in hospitals. The committee asked Scios to begin warning doctors against the drug’s use in outpatients, a treatment that had not been approved by the Food and Drug Administration but that had helped turn Natrecor into a big money maker.

The committee did not stop there. Over the last two months, some members have expressed concern about the ways Scios has responded to its recommendations. To register the committee’s dissatisfaction, Dr. Braunwald has sent Scios several letters and has gone so far as to ask for changes in company-sponsored medical education presentations about Natrecor, several members said.

“I think that, not surprisingly, the panel was concerned that the recommendations be taken seriously,” said one member, Dr. John C. Burnett of the Mayo Clinic College of Medicine, who added that Dr. Braunwald had recently told the committee that Scios was heeding its concerns.

Dr. Braunwald, a renowned heart-failure specialist, did not respond to several requests for an interview. Scios defended its response to the Braunwald committee’s recommendations and said it was preparing to expand its physician outreach campaign warning doctors against using Natrecor in outpatients.

The company also said that, as of July 29, it had revised a toll-free telephone line that had coached doctors and their staffs on how to file insurance claims for outpatient Natrecor infusions. Now, the line warns against such use.

The original phone line helped spur accusations from several leading cardiologists that Scios was promoting Natrecor for an unapproved use. They sounded alarms after concluding that Natrecor might raise the likelihood of potentially fatal kidney problems and questioning whether the drug was worth its high cost – about $500 per infusion.

Although doctors can administer drugs to patients as they see fit, a company’s promotion of drugs for unapproved, or off-label, use is illegal. Scios’s Natrecor marketing program, and whether it actively promoted an off-label use of the drug, is now the target of a Justice Department investigation in Boston.

Financial analysts viewed Natrecor as a potential blockbuster when it arrived on the market in 2001. But after the drug reached $400 million in sales last year, its sales are off 20 percent this year, the company has said. The primary benefit of Natrecor, a manufactured version of a naturally occurring cardiac hormone, is that it temporarily makes breathing easier for a heart-failure patient.

Some committee members said that their concerns about Scios’s handling of their recommendations began soon after the panel reported its findings to the company on June 13. The report’s crucial finding was unambiguous: Natrecor should not be used in outpatients.

But rather than simply disseminate the report, Scios created its own prefacing news release. The committee’s conclusion that Natrecor should not be used in outpatient settings was not clearly stated until the final page of the five-page company document. Instead, the news release played up the panel’s recommendation that Scios gather further data by continuing with a clinical trial, called Fusion II, to determine the drug’s usefulness in outpatients.

“The press release emphasized a small aspect of our recommendations – that clinical trials should continue; it de-emphasized or made little mention of the more important take-home points of our recommendations,” said Dr. Milton Packer, a cardiologist at the University of Texas Southwestern Medical Center in Dallas who served on the committee.

Dr. Packer also said that the committee members were shocked several weeks later when they received invitations as part of a mass mailing to enroll in a continuing medical education program, financed by Scios, that seemed to promote the outpatient use of Natrecor, whose chemical name is nesiritide.

“We were flabbergasted.” Dr. Packer said. “Scios was sponsoring meetings to discuss nesiritide and its potential use in outpatients.”

The mailing, and a later one, provoked a request from the committee that it be permitted to review the medical education presentations, which are intended to provide doctors with educational credits to keep their qualifications up to date.

A spokesman for Scios, Mark Wolfe, said that although a grant from Scios financed the Natrecor presentations, they were run by an independent company, which was responsible for their content. Mr. Wolfe also said that the program had been authorized months before the Braunwald committee recommendations.

Dr. Burnett of the Mayo Clinic said that Scios had sent Dr. Braunwald review copies of the presentations, which he had distributed to other committee members.

One cardiologist whose continuing medical education work was vetted by Dr. Braunwald’s committee, Dr. Mandeep Mehra, took exception to the review.

“It is not appropriate for a panel of individuals to change a C.M.E.-based presentation and exercise influence,” said Dr. Mehra, the chairman of cardiology at the University of Maryland Medical Center in Baltimore.

Dr. Mehra, whose presentation in July was part of a videotaped webcast, said the Braunwald committee had succeeded in having one slide added to his presentation, emphasizing the panel’s opposition to outpatient Natrecor use.

Some Braunwald committee members were also troubled by what they saw as an overly dense “Dear Doctor” letter sent to physicians on July 13, the first step in a company physician education program to tell doctors that Natrecor should not be used in outpatients.

While the letter highlighted the panel’s findings more prominently than the news release had, Dr. Packer said the 11-page packet was too long and “impossible for any doctor to get through.”

Dr. Burnett said that he had found the letter satisfactory but that some members of the panel were dissatisfied with it. “Busy doctors aren’t going to sit there and page through this thing,” he said.

For Scios, the good news in the panel’s report was the recommendation that the Fusion II clinical trial of outpatient use of the drug should continue. But Mr. Wolfe, the Scios spokesman, confirmed yesterday that bad publicity about the drug had made enrolling patients in Fusion II more difficult.

And regulators in India recently shot down an effort by a contract research organization to enroll patients in Fusion II. They ruled in July that the trials could not be conducted on Indian volunteers because “there were several adverse reports about the product and it was also not meant for use in India.”

In a statement yesterday, Scios said it still hoped that Indian officials would eventually approve Fusion II study sites there.

Copyright 2005 The New York Times Company

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