|Selected news articles which highlight important policy issues.||
News: Weekly Archives
News for the week of 10-10-2006
Report Faults FDA on Drug Safety
There is an old journalist's adage to the effect that if something happens all the time"dog bites man" being the typical illustrationit isn't a story worth running. "Man bites dog," on the other hand, is page A1 material. The same theory holds true for public policy, particularly when it comes to the FDA.
When a prescription drug works exactly as intendedas they do every day for the vast majority of Americansno one notices. Singling out rare adverse events, on the other hand, garners great press coverage and a plethora of Congressional hearings. On the heels of a recent report from the Institute of Medicine criticizing the FDA, more experts are weighing in on the perceived shortcomings of the agency:
Five experts who have advised the Food and Drug Administration on drug safety yesterday threw their weight behind mounting criticism that the agency does not adequately protect the public from unsafe drugs.
The FDA are certainly has problems that are worth addressing: the need for increased funding, improving the agency’s ability to monitor adverse events after a drug has entered the market, and finding more effective ways to communicate emerging safety signals to physicians and patients. Some are tough technical problems that resist quick solutions, such as finding better biomarkers for liver and kidney toxicity. The FDA has already embarked on a number of promising initiatives in many of these areas.
How good of a job is the agency really doing on drug safety? Getting the right answer to this question requires weighing the relative trade-offs between safety and benefits, because slowing down drug approvals to analyze more data or request larger and longer clinical trials inevitably lengthens the time it takes for new medicines to reach patients.
Some researchers believe that the FDA is actually too cautiousa view the authors of this thoughtprovoking article from the Milken Institute Review, "How safe is too safe?" hold. When it comes to the FDA, this may be the real "man bites dog" story, but is not one that we often hear.
Lawmakers Express Distrust of CDC on Vaccine Studies
The controversy over vaccine safetyspecifically that vaccines may be related to neurodevelopmental diseases like autismis unlikely to go away because frustrated and frightened parents demand absolute answers from scientists who can only speak in terms of probabilities. Based on all of the credible evidence we have nowfrom the CDC and the Institute of Medicine, and from U.S. as well as foreign researchersthere is no link between vaccines and autism. That is simply all science can say that on this pointor on any other point, for that matter.
Asking science to prove a negative is a rhetorical feint that obscures the fact that no study could restore "absolute trust" in vaccines. Unfortunately, some members of Congress are blithely ignoring this fact and are preying on parent's fears for political advantage.
"Parents deserve answers," Maloney said when the bill was introduced. "As the most scientifically advanced country in the world, we should be able to conduct a comprehensive study of the health effects of vaccines to restore absolute trust in the nation's vaccine program."
For more information on the vaccine safety debate, please see our interview with Dr. Paul Offit on vaccine development.
States Take Lead On Health Care As Budget Pinch Forces Reform
America's federal structure encourages states to act as innovative laboratories for new social policies, as Justice Brandeis famously observed. Wisconsin's welfare reforms in the early 1990s, for example, eventually became the model for the landmark welfare reform legislation Congress passed in 1996. This Investors Business Daily article shows that Medicaid, the joint statefederal healthcare program for the poor and disabled, may be the next policy area in which the states lead Washington, D.C. to implement effective reforms.
States can't afford to let health spending get further out of control because they must, by law, have balanced operating budgets, said Kala Ladenheim, program director of the forum for state health policy leadership of the National Conference of State Legislatures.
It is too early to tell which model may turn out to be the most effective, but it is encouraging that, while Congress seems unable to pass even modest health care reforms, governors and state legislators are taking real political risks.
A Poor Report Card
The National Health Service in the United Kingdom was up for a national review recently, and the Economist reports that it appears to have done rather poorly:
WHETHER or not the National Health Service is granted greater independence from politicians, the vast sums of public money flowing into it demand close scrutiny. The Labour government set up the Healthcare Commission to provide an independent check on the quality of NHS services in England. On October 12th it delivered a damning indictment.
The NHS, along with health systems throughout the developed world, are essentially trying to bring market forces and market discipline to bear in what are essentially thirdparty payer systems. Tinkering at the margins will undoubtedly help things along, but the biggest gains seem to comein places like Switzerland and elsewherewhen consumers have the financial clout to drive quality improvements.
Two doctors sound alarm on heart stents
Information technology and new statistical tools are revolutionizing the way we perceive safety in medicine, as researchers uncover ever more subtle differences in outcomes from medical treatments. For instance, sophisticated re–analysis of clinical trial data and the "real world" outcomes data that large public and private insurers collect can uncover rare safety signals—like the link between Vioxx and heart attacks—that might otherwise have escaped notice for years.
Take, for instance the growing debate over the increased possibility of death resulting from the use of drug–coated stents, rather than uncoated stents, as reported in this article from the Miami Herald.
While federal authorities sounded huge alarms after one death was caused by tainted spinach, they have done virtually nothing to reduce the more than 2,000 unnecessary deaths a year caused by drug–coated stents, alleges an editorial on the website of a major medical society. The editorial—written by two Los Angeles physicians at a website run by the American College of Cardiology—could have a major effect on Cordis, the Miami Lakes company that produces one of the stents, small metal tubes inserted in arteries to keep them open after blockages occur.
The analogy to Vioxx is instructive, as the Agency for Health Care Quality and Research (AHQR) recently published an analysis comparing the relative risks of new and old pain treatments for osteoarthritis. The analysis found that new COX–2 inhibitors, such as Vioxx, posed risks and benefits similar to those of drugs that have been on the market for decades.
The good news, when it comes to drug–coated stents or any other medical intervention, is that we are only at the earliest stages of analyzing the relative risks involved. Over the long term, medical researchers will find ways to make the diagnosis and treatment of diseases much more personalized and cost effective.
The bad news is that we have limited ability today to predict exactly which patients are most at risk for adverse effects. This uncertainty is bound to generate pressure on regulators to set blanket rules with the goal of protecting everybody, while lawyers will continue to bring litigation second–guessing every decision. Right now, the FDA seems to be taking the right approach, convening a panel to look at the evidence and sort out what we do and don’t know.
Until we make a quantum leap in diagnostics, the bottom line is that patients and doctors are going to have to keep doing what they have always done: Make educated guesses about what treatments are most appropriate on an individual basis.
Drug Reactions Send 700,000 Yearly to ER
The media tends to exaggerate the risks of newer, patented drugs–in part because these drugs are the most heavily advertised, and thus constantly in the public eye. But a new report from government agencies suggests that older, widely used treatments generate a vast number of adverse events.
Harmful reactions to some of the most widely used medicines—from insulin to a common antibiotic— sent more than 700,000 Americans to emergency rooms each year, landmark government research shows.
In other words, all drugs come with their own risks and benefits. The ancient Greeks knew this, and used the same word–pharmakon–for medicine as they did for poison. Still, we shouldn't panic. After all, the basic premise of medicine is not that treatment is without risks, but that the diseases we are trying to cure present greater risks.
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