March 2, 2006 at 05:40:02

View Ratings | Rate It

Natrecor Heart Drug - Deadly and Expensive

By Evelyn Pringle (about the author)     Page 2 of 3 page(s)

opednews.com     Permalink

A study that appeared in the April 20, 2005 issue of the Journal of the American Medical Association, found patients treated with Natrecor were 80% more likely to die in the 30 days following the treatment than patients given a placebo. And one trial found kidney problems were occurring at a rate three times that found in patients taking a placebo, according to a June 13, 2005 report by Health Day News.

The study was conducted by researchers Dr. Jonathan Sackner-Bernstein, of the North Shore University Hospital in Manhasset, N.Y; Drs. Marcin Kowalski and Marshal Fox, of St. Luke's-Roosevelt Hospital Center in New York; and Dr. Keith Aaronson, of the University of Michigan.

In their study, the team collected data on 1,269 heart failure patients who participated in five clinical trials comparing Natrecor with other drugs. "We found that there is a 40 to 50 percent higher risk of worsening kidney function when people are treated with nesiritide than when people are treated with other medications," Sackner-Bernstein said, according to a March 21, 2005 article by Health Day News

In attempt to discount this damaging analyses, in April 2005, Johnson & Johnson appointed renowned heart specialist, Dr Eugene Braunwald, to form a committee to review the drug studies. Dr Braunwald's committee reached the same conclusion, that it was inappropriate to use Natrecor, except in acutely ill hospitalized patients.

Specifically, the panel recommended that Natreor should be used only in patients who show up at the hospital with an acute heart failure; that it should not replace diuretics, the front-line heart failure treatment; and that it should not be used for outpatients, where patients scheduled appointments to receive the drug ahead of time. The committee made the following verbatim recommendations:

1) The use of Natrecor should be strictly limited to patients presenting to the hospital with acutely decompensated congestive heart failure who have dyspnea at rest, as were the patients in the largest trial that led to approval of the drug (VMAC). Physicians considering the use of nesiritide should consider its efficacy in reducing dyspnea, the possible risks of the drug summarized above, and the availability of alternate therapies to relieve the symptoms of congestive heart failure.

2) Nesiritide should not be used to replace diuretics. Furthermore, because sufficient evidence is not currently available to demonstrate benefit for the applications listed below, nesiritide should not be used:

For intermittent outpatient infusion
For scheduled repetitive use
To improve renal function
To enhance diuresis.

3) Scios should immediately undertake a pro-active educational program to inform physicians regarding the conditions and circumstances in which nesiritide should and should not be used, as described above. Sponsor supported communications, including review articles of nesiritide, should reflect the above recommendations. Scios should ensure that current and future marketing and sales activities related to nesiritide are consistent with this educational program.

Although Scios spokespersons have argued that they can not control how doctors prescribe Natrecor, Scios itself created the problem by encouraging and praising off-label use right from the start.

Back on April 2, 2002, Scios issued a Press Release to announce that "net sales for its flagship product Natrecor(R) (nesiritide) were $15.4 million in the first quarter of 2002, a 60 percent increase over the prior quarter ended December 31, 2001."

The company could not have been more enthusiastic about the drug's off-label use. The press release bragged about the profits from off-label use. "We achieved better than expected sales due to greater than expected physician prescribing of Natrecor for their patients suffering from acute heart failure," said Richard Brewer, President and CEO of Scios at the time. "Our market research shows physicians are increasingly interested in using Natrecor in a variety of clinical settings," said Thomas Feldman, Vice President of Sales and Marketing at Scios at the time.

The company also noted that Natrecor had received a pass-through code from the Centers for Medicare & Medicaid Services that allowed reimbursement for patients treated in an outpatient setting, and said that the issuance of a code was a further indication of the growing therapeutic importance of Natrecor and would help increase use of it in outpatient settings.

"We believe this is a significant step toward making Natrecor more widely available to the physicians and patients who need it, and creates a bigger market for the product," the Press Release said.

The code makes the economics of prescribing the product more attractive for physicians interested in using it for their patients in the outpatient setting, "an area in which Natrecor is particularly well-suited because it is easy to use, has a good safety profile and makes patients feel better," the release said.

Doctors seeking reimbursements for off-label outpatient treatment were directed to call a toll-free hotline to obtain billing codes and forms.

 1  |  2  |  3

 

 

View All Book Recommendations

Share this page: (what's this?)                   Tell a Friend:

                                                      (More...)

 

Most Popular Articles in the Last 2 Days (by Recommend Emails) Kucinich: Why I Voted NO by Dennis Kucinich House Passes Weak Public Option Health Care Bill, Selling Out Women's Rights. Includes Democrats Who Voted Against Bill by Rob Kall Why is it we have finite resources for health care but unlimited money for war? by Dennis Kucinich The Evil Empire by Paul Craig Roberts Another Neocon Makes Turkish Ties & Connections Official by Sibel Edmonds A Special Report -- The Crazy October Surprise Debunking by Robert Parry Rendition Prosecuted Abroad While U.S. Courts Do Nothing by Mary Shaw Fort Hood's Killer Shrink: Was He One of the Army Docs Pressured to Misdiagnose PTSD in Soldiers? by Harkavy Hillary, Congress Bury Goldstone Report, Shirking Accountability for US Role in Gaza Raids by Eileen Fleming How to End Wars by David Swanson Go To Top 50 Most Popular