Susan Wood, a professor at George Washington University's school of public health and former FDA whistleblower, wrote an op-ed in today's Boston Globe examining how President Bush has undermined the federal government's role in assuring public health by staffing agencies with inappropriate people — or simply not staffing them at all.

Wood accuses Bush of refusing to "staff important health-related positions with qualified individuals willing to provide science-based advice." She provides a list of important government posts currently filled by interim appointees. (The "acting" status of important government positions is a government-wide problem.)

As Wood points out, filling top government posts with unqualified leaders — or refusing to fill them at all — leads to scientifically questionable decision making. Ultimately, that can undermine the important public health protections our government has a responsibility to provide. Wood concludes by stating:

To ensure the health of our families we need strong, consistent leaders who value the integrity of science, make decisions on the best available information, and support prevention. Without that leadership, we will not succeed in promoting the health of all Americans.

Reg•Watch often complains about the flaws of cost-benefit analysis and the overemphasis policy makers place on it as a tool in decision making. However, when discussing cost-benefit analysis in the abstract, it is difficult to show the practical problems associated with its use.

For a case example showing just how problematic cost-benefit analysis can be, read OMB Watch's new analysis, Polluted Logic: How EPA's ozone standard illustrates the flaws of cost-benefit analysis in regulatory decision making.

Polluted Logic tracks EPA's current revision of the national standard for ozone and shows how the use of cost-benefit analysis in the rulemaking has been useless to policy makers and has only complicated the debate over whether to tighten the standard.

As the paper discusses, EPA's ozone standard serves as a case example of some of the big problems with cost-benefit analysis in regulatory decision making:

• Cost-benefit analysis is problematic for health, environment, civil rights, and safety rulemakings because of the magnitude of intangible and invaluable benefits;
• Cost-benefit analysis often runs counter to congressional intent expressed in federal law; and
• Cost-benefit analysis allows the White House Office of Information and Regulatory Affairs to manipulate regulations to serve an intended ideological agenda.

Download the paper here: Polluted Logic: How EPA's ozone standard illustrates the flaws of cost-benefit analysis in regulatory decision making.

The New York Times has a recap of the oral arguments heard yesterday by the Supreme Court in Riegel v. Medtronic. As Reg•Watch blogged yesterday, the issue is whether federal regulation preempts state common law claims against medical device manufacturers.

In March, FDA issued draft guidelines that would revise its criteria for determining whether scientific advisory committee members have financial conflicts of interest. FDA advisory committees are standing panels comprised of individuals considered experts in a particular field. They provide advice to FDA on matters such as drug and medical device safety.

While the guidelines would be a good step toward ensuring scientific integrity on FDA panels, they would also make it too easy for FDA to grant waivers to conflicted scientists. For example, if FDA determines an individual has a financial conflict, the guidance instructs agency personnel to ask: "Does the need for the individual's services outweigh the potential for a conflict of interest?" If the answer is "yes," the member could serve on the panel but could not vote.

FDA argues that certain individuals have unique experience and qualification and, regardless of financial conflicts, are necessary for the panel. In fact, FDA recently issued a report which concluded it would be too difficult to create conflict-free advisory panels.

But a new investigation by the Center for Science in the Public Interest (CSPI) debunks that myth. CSPI analyzed the same data FDA used for its study, but came to a different conclusion:

For each of the four advisory committees analyzed in the study, it would have taken a single FDA official just one week to replace all the advisers who had conflicts of interest with experts who do not have conflicts of interest, according to CSPI's analysis of the ERG data. Moreover, the FDA would be able to choose from nearly two potential unconflicted experts for every open slot. And, based on the same criteria for the expertise of potential committee members used in the study, these easily identifiable unconflicted experts would be more qualified than the ones eventually chosen, whether they had conflicts of interest or not.

A case being argued before the Supreme Court today could affect the way consumers seek redress from companies when harmed by faulty drugs or medical devices. The case, Riegel v. Medtronic, "was brought by the family of a New York man who suffered severe medical complications when a balloon catheter burst during a procedure to clear his arteries," according to The Los Angeles Times.

Medtronic is arguing federal regulations serve as a shield which protects it from tort claims. Since FDA approved the medical device, Medtronic believes it bears no responsibility for injuries caused by its use.

As the LA Times reports, the case has broad ramifications: "The question in the catheter case is whether Congress intended to bar state common law claims when it gave the FDA authority to regulate medical devices in 1976."

In fact, Congress did legislate a regulatory system in which state regulations cannot supersede federal ones. Congress recognized 50 different sets of rules would be a nightmare for pharmaceutical and device companies seeking approval and would put consumers at greater risk.

But Medtronic is trying to compare apples and oranges. The positive law enacted by the U.S. Congress and state legislatures is different than the common law created by the courts in tort claims like this one.

The Bush administration has also been conflating these two types of law in its war on torts. A series of federal regulations have included language that preempts tort claims against companies in compliance with federal regulations. More on that here.

Update: The New York Times recaps oral arguments (12/05/2007)

Posted by Matt Madia, 10:28:54 AM