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Volume 3, Number 33
October 13, 2006


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In the Spotlight

FDA Advisory Committees and Conflicts of Interest: Understanding the Coinage of the Realm

John Calfee, Medical Progress Today, 10-11-06

The Institute of Medicine (IOM), part of the prestigious National Academy of Sciences, recently published a report on FDA oversight of drug safety. The IOM report was sufficiently critical of the FDA to generate newspaper headlines like "FDA Told U.S. Drug System Is Broken” (Washington Post, September 23, 2006, p. A1) and "Study Condemns FDA's Handling of Drug Safety" (New York Times, September 23, 2006).
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News

States Take Lead On Health Care As Budget Pinch Forces Reform
Investor's Business Daily, 10-11-06

Editor's Notes:

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 state–federal 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.
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Report Faults FDA on Drug Safety
Washington Post, 10-10-06

Editor's Notes:

There is an old journalist's adage to the effect that if something happens all the time—"dog bites man" being the typical illustration—it 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.
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Lawmakers Express Distrust of CDC on Vaccine Studies
FoxNews.com, 10-10-06

Editor's Notes:

The controversy over vaccine safety—specifically that vaccines may be related to neurodevelopmental diseases like autism—is 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 now—from the CDC and the Institute of Medicine, and from U.S. as well as foreign researchers—there is no link between vaccines and autism. That is simply all science can say that on this point—or on any other point, for that matter.
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$1 billion would go toward developing bioterror remedies
The San Diego Union-Tribune, 10-6-06

Editor's Notes:

According to many experts, Project Bioshield—the program Congress created in 2004 to spur private sector research and development into countermeasures against potential bioterror attacks—has floundered in a sea of bureaucratic red tape.
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Pay Organ Donors, Experts Suggest
, 10-6-06

Editor's Notes:

Patients in need of organ donations routinely die on waiting lists for the relatively few organs other people have voluntarily donated—leading to a large and growing black market in organ sales. Thankfully, there is a solution: creating a regulated market with appropriate safeguards and compensation for prospective donors. In this article, a prominent American academic defends the concept in the British Medical Journal.
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New Sense of Caution at F.D.A.
The New York Times, 9-28-06

Editor's Notes:

A former FDA official once observed that the agency is a "slow moving target that bleeds profusely when hit," largely because Congressional oversight of the agency focuses relentlessly on why supposedly "bad" drugs like Vioxx get approved in the first place. Consequently, the agency's political incentives largely tilt towards slowing down new drug approvals. Disease categories such as AIDS and cancer are the notable exception because there are particularly well–organized and vocal patients' groups that can provide political cover for its regulatory decisions.
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Commentary

Protecting the Health of the Public—Institute of Medicine Recommendations of Drug Safety
Sheila Burke, Bruce M. Psaty, Ph.D., New England Journal of Medicine, 10-26-06

Psaty and Burke, two members of the Institute of Medicine committee tasked with reviewing the FDA's drug safety procedures, explain and defend their panel's findings.
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Anthrax and Lawyers
Peter Huber, Forbes, 10-16-06

Huber, a senior fellow at the Manhattan Institute for Policy Research, explains why pharmaceutical companies remain reluctant to invest in products to treat or prevent potential bioterror attacks.
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Drug Dilemma
John Calfee, AEI-Brookings Joint Center for Regulatory Studies, 10-10-06

Calfee reviews Overdose: How Excessive Government Regulation Stifles Pharmaceutical Innovation, a new book by Richard Epstein, who teaches at the University of Chicago Law School.
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The Revival of a Notorious Solution to a Notorious Scourge
Tina Rosenberg, The New York Times, 10-5-06

Rosenberg takes wealthy nations to task for not supporting the effective and responsible use of DDT to control malaria in developing nations—but also notes that the U.S. is now leading the fight for better malaria control programs.
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Poor U.S. Scores in Health Care Don't Measure Nobels and Innovation
The New York Times, 10-5-06

While America's health care system may seem worse off than state–funded systems in Europe and Canada based on the U.S.'s higher costs and some public health measurements, Cowen warns that the reality is far more complicated because the U.S. leads the world in medical innovation, in effect underwriting global health gains.
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Are Bad Drugs Coming to a Pharmacy Near You?
Henry I. Miller, Tech Central Station, 10-4-06

Dr. Miller reviews what we know about the global trade in counterfeit drugs, and what can be done to protect the U.S. drug supply in an increasingly global market.
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Markets and Medicare
Wall Street Journal, 10-4-06

Although the Journal continues to have reservations about the fiscal wisdom of the Medicare drug benefit, this editorial recognizes that the program—thanks to market–based competition—has helped to contain costs and offer more choice to seniors. After reviewing the program's victories, it goes on to suggest additional market–based Medicare reforms.
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Research

Research and Development in the Pharmaceutical Industry
Congressional Budget Office, 10-13-06

This CBO paper is an interesting addition to the existing literature on pharmaceutical industry investment and productivity. However, it also points out that the U.S.'s heavy reliance on third–party health insurance may encourage consumers to overspend on some kinds of health care, including pharmaceuticals.
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Aetna Releases Broadest Study to Date of Consumer Directed Plans
Aetna News, 10-2-06

Aetna has released a study of the effects of consumer–directed plans on its 1.6 million members. The study found that, "five years after the launch of Aetna HealthFund, consumer–directed plans consistently result in lower medical costs, maintained or improved levels of chronic and preventive care, and increased usage of generic medications and consumer tools and information." Among the study's other findings:
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In this week's issue:

SPOTLIGHT

FDA Advisory Committees and Conflicts of Interest: Understanding the Coinage of the Realm

NEWS

States Take Lead On Health Care As Budget Pinch Forces Reform
Report Faults FDA on Drug Safety
Lawmakers Express Distrust of CDC on Vaccine Studies
$1 billion would go toward developing bioterror remedies
Pay Organ Donors, Experts Suggest
New Sense of Caution at F.D.A.

COMMENTARY

Protecting the Health of the Public—Institute of Medicine Recommendations of Drug Safety
Anthrax and Lawyers
Drug Dilemma
The Revival of a Notorious Solution to a Notorious Scourge
Poor U.S. Scores in Health Care Don't Measure Nobels and Innovation
Are Bad Drugs Coming to a Pharmacy Near You?
Markets and Medicare

RESEARCH

Research and Development in the Pharmaceutical Industry
Aetna Releases Broadest Study to Date of Consumer Directed Plans
Center for Medical Progress 
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