Natrecor Advisory Panel Report is Probably Not What Drug Maker Expected, or Wanted

In the August 9, 2005 edition of The New York Times, reporter Stephanie Saul succinctly characterized the current Natrecor situation:  "Call it the advisory committee that keeps on giving advice."

As discussed in in a May 2005 Natrecor "Dear Doctor" letter, in early 2005 two medical studies raised concerns about the safety of the heart-failure drug Natrecor, particularly when it was used in an outpatient-clinic setting.  Scios, the unit of Johnson & Johnson (J&J) responsible for Natrecor, responded to this disturbing news by convening a panel of independent medical experts to serve as an outside advisory panel in April 2005.

In June 2005, Dr. Eugene Braunwald, of Harvard Medical School, and his committee came back to Scios and J&J with their report of findings and recommendations.  Essentially, Dr. Braunwald’s committee found that the use of Natrecor should be strictly limited to acutely ill patients in hospitals, the indication for which Natrecor was approved by the FDA in 2001. Further, this so-called advisory panel recommended that Scios and J&J begin to pro-actively warn potential prescribing doctors against the use of Natrecor in outpatients, a treatment not approved by the FDA, thus an "off-label" use. 

This may not have been the type of report that Scios and J&J had hoped for from Dr. Braunwald and his fellow medical experts. Simply put, it was the increasing level of off-label prescribing that been had moving Natrecor in the direction of being one of those "blockbuster" drugs which drug companies relish.

As indicated by Ms. Saul’s characterization of the Natrecor advisory panel situation, Dr. Braunwald and his committee did not call it quits after tendering their report to Scios and J&J in June 2005. According to Ms. Sauls’ August 9, 2005 article in The New York Times:

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.

For example, late last month, Scios and J&J announced that a Natrecor toll-free telephone line would warn prescribing doctors against outpatient Natrecor infusions — whereas, previously, that same Natrecor toll-free telephone line that had informed doctors and their staffs on how to file insurance claims for that type of off-label use.

As an aside, it is important to understand that although doctors can prescribe FDA-approved drugs to patients as they see fit — including as therapy for indications not considered by the FDA during their approval process — a drug company’s promotion of any FDA-regulated drug for unapproved, or off-label, use is illegal. In fact, Scios’s Natrecor marketing program is now the target of a Justice Department investigation in Boston which seems directed at the issue of whether Scios and J&J actively promoted an off-label use of Natrecor.

Returning to Ms. Sauls’ August 9, 2005 article in The New York Times:

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.

Lastly, Ms. Sauls reported that some Natrecor advisory panel members were "troubled" by the lengthy July 13, 2005 Dear Doctor letter sent by Scios and J&J to explain their findings and recommendations.  Those members reportedly saw this Natrecor Dear Doctor letter as "overly dense" and, at 11-pages long, too long to expect any relatively busy doctor to review carefully — which is the intended purpose of any Dear Doctor letter.

(Posted by: Tom Lamb)