Thursday, July 14, 2005

A "Tune-Up" from Nesiritide?

Here is another story about a pharmaceutical company appearing to go well beyond the evidence in its promotion of a new, expensive drug.
This week's New England Journal of Medicine features a Perspectives article on the marketing of nesiritide, sold as Natrecor by the Scios division of Johnson & Johnson. (Topol EJ. Nesritide - not verified. N Engl J Med 2005; 352: 113). Also, an article about the marketing of the drug appeared in the Boston Globe.
The main points made by Topol were:
  • Two randomized controlled trials of nesiritide showed that it lead to short-term improvement in the pulmonary capillary wedge pressure (PCWP) of patients with acute decompensation of congestive heart failure (CHF). PCWP assesses the degree of lung congestion. One trial also showed some short-term symptom improvement.
  • Both trials showed increases in 30-day mortality of patients treated with nesiritide, although these increases did not achieve statistical significance, i.e., could have been due to chance alone. However, the trials were to small to prove that nesritide did not lead to a higher risk of death.
  • Patients who received nesiritide also had a higher rate of kidney problems, but again, this could have been due to chance.
  • No trial demonstrated any long-term improvement in any clinically important outcome due to nesiritide.
  • There have been no controlled trials of nesiritide used for prolonged periods of time, or in out-patient settings.
  • Nonetheless, previous news reports, and the new Boston Globe article showed that Scios has been encouraging physicians to open "infusion centers" to administer nesiritide to outpatients over weeks or months, as a "tune-up." Each dose of nesiritide in this setting costs about $500. The company set up a telephone hotline to help physicians get reimbursement for this service, and published a "Natrecor Reimbursement and Billing Guide," that shows how physicians can collect professional fees for outpatient nesiritide administration. The Globe quoted Dr. Steve Nissen from the Cleveland Clinic, "my moral compass went off when I saw this. It felt like the company was promoting the use of a drug to profit physicians, rather than to benefit patients." However, Mark Wolfe, a Johnson & Johnson spokesman, said "Scios does not promote Natrecor for regular, scheduled outpatient infusions."
Topol concluded, "in my view, nesiritide has not yet met the minimal criteria for safety and efficacy." So, "we need a tune-up of our procedures to eliminate indiscriminate use of drugs, such as nesiritide, when there is not proper evidence of their safety."


Anonymous said...

I find it very interesting for Topol to say that re: Nesiritide. WHY??? Because Topol had large $$ invested in the drug development company that WAS SUPPOSED to design and conduct the clinical trials. At the time, he said he was excited about Nesiritide, etc, blah blah. THEN, Scios switched to ANOTHER company. As a result, Topol lost A GREAT DEAL OF $$. He HAS a history of involving himself in things like this... Too bad he makes the conflict of interest so obvious. There is ALWAYS a story behind a story. I am A.B. (Harvard Physician) who is tired of what is going on. A true disgrace

Jose @ Chromatic Tuner said...

I wonder how much longer they need to meet the minimal criteria for safety and efficacy.