Healthy Skepticism Library item: 973
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Barrett A, Carey J.
"Off-Label" Drugs: J&J Is Pushing The Envelope.
Business Week 2005 Apr 25
http://www.businessweek.com/magazine/content/05_17/b3930071_mz011.htm
Full text:
Regina Massaro, a nurse practitioner with South Bay Cardiovascular Associates in West Islip, N.Y., is something of an evangelist for Johnson & Johnson’s drug Natrecor. Developed by J&J’s Scios unit, the drug was approved in 2001 by the Food & Drug Administration for the short-term treatment of heart-failure patients who are having serious problems breathing.
Massaro believes the drug may be helpful to a broader range of patients.
Indeed, her boss, Dr. Larry M. Altschul, was one of the first to use Natrecor longer-term to treat patients with heart failure — an experimental therapy known as an “off-label” use of the drug because the FDA did not specifically approve it for such treatment. And Massaro says that Scios has paid to send her to meetings with doctors and nurses around the country six times in the past two years to talk about heart-failure management. Because FDA regulations ban the promotion of such off-label uses, she can’t bring up the subject of chronic Natrecor therapy herself. But Massaro says she frequently gets questions on that topic — and under the rules she is then free to discuss her experiences. “I do get asked about it a lot because we are the ones who pioneered it,” Massaro says.
By many accounts, longer-term use of Natrecor is growing. Despite questions about whether the drug could harm kidney function, and whether it could be linked to a higher mortality rate, Natrecor is expected to rack up nearly $700 million in sales this year. While no evidence has surfaced that Scios has broken the rules when it comes to marketing, the company has made moves, including the meetings by South Bays’ Massaro, that prompt discussion of the drug’s off-label uses.
In a statement, Scios says it is marketing Natrecor according to its approved label. The company is conducting trials looking at whether the drug might help people when given on a regular, weekly basis. Yet Scios says its people are not promoting that use — and the FDA has “communicated with them that they shouldn’t,” says a top agency official.
Certainly, using drugs in ways not spelled out on their label is widespread
— and often proper. Frequently drugs are studied for one condition, then physicians discover other benefits. South Bay’s Altschul says he has treated
148 patients with chronic infusions of Natrecor over the past three years and has seen it cut down on hospitalizations and improve quality of life.
But in the absence of full data from a large trial studying longer term infusions, the evidence so far is largely anecdotal.
In fact, others in the industry have gotten into hot water in recent years for overly aggressive marketing of off-label uses. In 2004, Pfizer (PFE ) agreed to pay more than $400 million to settle a case involving off-label promotion by a company it acquired. Yet despite such penalties, companies know that there is a lot of wiggle room in the current rules. For example, drugmakers are barred from pitching doctors directly on unapproved uses of their drugs. But if a doctor or nurse hears about an off-label use and asks a sales representative or someone like South Bay’s Massaro about it, those questions are permitted to be addressed.
There are other ways that companies can stimulate buzz about a drug.
Drugmakers often sponsor continuing medical education (CME) sessions where off-label uses can be debated. A few CMEs funded by Scios in the past few years have included information on weekly infusions of the drug.
A J&J spokesman says the company knows the general topics of the CMEs it funds, and it may have some input on speakers for those sessions. But he says the company does not control the content. However, Dr. Steven Nissen, a cardiologist at the Cleveland Clinic who was also part of the FDA panel that recommended approval of Natrecor, contends the discussion of off-label uses in CMEs clearly encourages physicians to consider those treatments. In short, those messages may be fueling the growth of an increasingly controversial drug.
