NIH: "No one seems to have studied long-term safety of NSAIDS"

In "Naproxen study halted by NIH" (Rick Weiss, Washington Post, Tue, Dec. 21, 2004) it is reported regarding the new findings about naproxen that:


That's a significant indictment of the way postmarketing surveillance is now conducted by the government and pharmaceutical industry, including the makers of OTC and generic drugs. There's likely little interest in making the significant investments to study OTC and generic drugs such as the NSAIDS, indicating some other mechanisms to accomplish surveillance of present and future "consumer medicines" for uncommon adverse effects (which can cause signficant actual harm through sheer volume of users) would be very helpful.

It would also help to study the drugs thoroughly before they become OTC/generic.

National-scale EMR, anyone?

-- SS

Addendum: the Dec. 1, 2004 JAMA article "Postmarketing Surveillance - Lack of Vigilance, Lack of Trust" by Fontanarosa, Rennie and DeAngelis discusses the defects in today's postmarketing surveillance processes in some detail. The following passage is particularly interesting:

... in some cases, serious adverse drug events are quite uncommon, and detecting them accurately and using them to determine incidence rates can be difficult with the existing passive system for voluntary reporting of adverse drug events. As illustrated in another article in this issue, Graham and colleagues used data from more than 250,000 patients treated with lipid-lowering agents from January 1998 through June 2001 in 11 managed care health plans, and identified 24 patients who were hospitalized with rhabdomyolysis during treatment. By virtue of having data from drug-specific, population-based inception cohorts, the authors estimated an incidence of rhabdomyolysis of 5.34 per 10,000 person-years for cerivastatin monotherapy, and 1035 per 10,000 person-years for combined cerivastatin-fibrate use (ie, risk of rhabdomyolysis of approximately 1 in 10 patients treated with the combined therapy per year).

The widepread use of EMR would make such analyses much easier to accomplish, and provide data of significantly greater scope and quality. Are FDA and Big Pharma paying adequate attention?

"This is a very confusing situation," said Sandra L. Kweder, deputy director of the Food and Drug Administration's Office of New Drugs, speaking to reporters at a hastily convened telephone news conference last evening. Naproxen has been on the market since 1976, Kweder noted, and "this is the first evidence we've seen that suggests there is a risk." She and other officials acknowledged, however, that no one seems to have studied the long-term safety of naproxen or, for that matter, any of the other popular painkillers known as nonsteroidal anti-inflammatory drugs.