Side Effects - Pharmaceutical Executive

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Side Effects
From research to regulation, drug safety is setting the agenda.


Pharmaceutical Executive



Jill Wechsler
Drug safety has become the issue for pharma, its regulators, and its critics. The past few weeks have seen the issue receiving a new level of attention in almost every area of drug development, regulation, and marketing. The latest round of events—from dropped research projects to new regulatory proposals—show just how pervasive safety worries are likely to become in the months to come.

Raising the Bar One response to today's safety concerns is particularly alarming: The research community has become skittish about clinical studies that involve pain medications and other high-risk treatments. In December, researchers halted an important NIH-sponsored study to test whether COX-2 inhibitors might help prevent colon cancer. The study was killed when data from more than 2,000 patients indicated that those taking Pfizer's Celebrex (celecoxib) were experiencing more cardiovascular events.


No surprises
A few days later, NIH halted a study testing whether naproxen (Bayer's Aleve) or Celebrex might help delay the onset of Alzheimer's disease in high-risk individuals. This time the researchers found cardiac risks in patients taking naproxen—but not Celebrex. Despite the mixed safety signals, investigators also put a hold on additional NIH cancer trials seeking evidence of additional uses for commonly prescribed painkillers. Some 40 studies testing Celebrex for various purposes are currently under review. Pfizer believes the data are inconclusive about safety and may yet reveal anti-cancer benefits. Pfizer is keeping Celebrex on the market pending review—but will comply with an FDA request to halt direct to consumer advertising for Celebrex and to provide more risk information to doctors pending further safety evaluation.

The panel that conducted the review acknowledge that the bad news about COX-2 safety problems led them to examine the adverse event data from these trials earlier than planned. Some cancer trials use doses much higher than those recommended for arthritis patients, which may have led to higher rates of side effects. But more than 20 million people have used these therapies, and the reviewers felt they had to be exceptionally cautious. FDA plans to address COX-2 issues at a meeting of its drug safety advisory committee late this month and is working with the Institute of Medicine (IOM) on a broader assessment of the agency's safety review activities. (see "Making Medical Errors Rare," )

More Comparisons Another response to drug safety problems has been to urge more head-to-head comparison of similar medicines. The Medicare bill authorized the HHS Agency for Healthcare Research & Quality (AHRQ) to support more research on comparative effectiveness of medical interventions—explicitly including prescription drugs—for the top 10 conditions affecting the elderly. AHRQ's 2005 budget contains $15 million for this initiative—much less than the $50 million initially proposed, but enough to get the program started.

In December AHRQ issued a long-awaited list of priority conditions warranting comparative study: ischemic heart disease, cancer, asthma, stroke, arthritis, diabetes, dementia, pneumonia, stomach ulcers, and depression. AHRQ will start by funding projects to review the scientific literature on outcomes of various treatments for these conditions. The aim is to help physicians and patients make informed treatment choices by communicating the results to Medicare, Medicaid, health plans, prescription drug plans, and the public. AHRQ is not supposed to set national standards of care, but its analysis is likely to lead to increased agreement on the relative effectiveness of certain interventions.


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