Medical Progress Today
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Volume 2, Number 35
September 30, 2005


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In the Spotlight

Making the perfect the enemy of the good
Why banning industry consultants from FDA Advisory Committees hurts patients

Derek Lowe, Medical Progress Today, 9-29-05

FDA advisory-committee members are supposed to provide expert opinion and guidance to the agency, and their meetings are designed to address the potential benefits and shortcomings of new drugs up for approval. The agency has traditionally granted conflict-of-interest waivers, because many of the experts that the FDA would want on these panels have worked with and often have financial ties to the companies involved.
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News

Report reignites debate over Medicare drug plan
The Boston Globe, 9-28-05

Editor’s Notes:

The Veteran’s Health Administration imposes price controls on prescription drugs, both branded and generics, that are listed on the VA formulary. These prices are some of the lowest in the developed world. Any manufacturer that refuses to comply with VA pricing will find its product excluded from the formulary. In short, the VA gets lower prices than any HMO or pharmacy benefits manager (PBM) could bargain from industry. This aspect of the VA program has largely gone unremarked. Until now, that is: Families USA, a consumer health-care group, has released a report touting the price difference between the VA formulary and the Medicare drug discount card (which will be phased out in a few months).
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Test Predicts Response to Cancer Drugs
Wall Street Journal, 9-27-05

Editor’s Notes:

Iressa was originally touted as a wonder drug designed to attack tumors with epidermal growth factor receptors (EGFR). After analysis of clinical data, however, it turned out that Iressa works for only about 10% of lung-cancer patients who take it. This doesn’t mean that the drug is a failure, however, because cancers in that 10% are particularly responsive to the drug. The problem, then, is discovering which patients happen to fall into that fraction, so doctors can maximize their chances of responding and avoid unnecessary treatments. Fortunately, a new genetic test that focuses on mutations in the EGFR genes in high-responding patients should help doctors prescribe Iressa and other targeted cancer drugs more effectively:
Continue reading . . .

Remicade May Prevent Surgery for Ulcerative Colitis Patients
Wall Street Journal, 9-26-05

Editor’s Notes:

Among patients with ulcerative colitis “only about 50%…respond to ‘first line’ treatments” to control the dangerous inflammation that accompanies the disease and that can “[require] surgical removal of the colon.” The FDA recently approved Remicade, a drug that is already widely used for rheumatoid arthritis, to help patients with ulcerative colitis who aren’t responding to other treatments.
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New FDA chief wants to prepare agency to foster transformation in medicine
Associated Press Newswires, 9-26-05

Editor’s Notes:

FDA Commissioner Lester Crawford’s resignation last week caught everyone by surprise. His interim successor, Dr. Andrew Von Eschenbach, is nonetheless in an excellent position to leverage FDA initiatives that can help advance the nascent development of personalized medicine and improve patient safety as part of the FDA’s “Critical Path” reforms.
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Many Insurers Set to Offer New Medicare Drug Plans
The New York Times, 9-24-05

Editor’s Notes:

Pundits of virtually every ideological stripe have been casting stones at the Medicare drug benefit since it was signed into law in 2003. One dire scenario that has failed to materialize, however, was the prediction that insurers would shun the plan and leave the government as the sole provider.
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Experts: Counterfeit drugs becoming major health threat in Europe
Associated Press Newswires, 9-22-05

Editor’s Notes:

While legislators in Congress muster for yet another effort to legalize prescription drug importation, government officials and law enforcement authorities in Europe, where importation is not only legal but actually required in certain quarters, find themselves besieged by a growing number of potentially dangerous counterfeit drugs.
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Commentary

The New Pill Isn't Always the Best Pill
Sally Satel, MD, National Review Online, 9-28-05

Satel, a practicing psychologist and senior fellow at the American Enterprise Institute, weighs in on the findings of a schizophrenia study published last week in The New England Journal of Medicine. The study compared an older, cheap generic drug, perphenazine, to four new, branded drugs, called “atypical antipsychotics.” The study found that the generic performed as well as the newer drugs on some measures, though Satel cautions that “the study, unprecedented in its scope, has much more data to yield.” She does, however, draw “two important conclusions” based on the current findings:
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Regime Change at the FDA
Wall Street Journal, 9-27-05

The Journal lauds the appointment of Dr. Andrew Von Eschenbach to replace outgoing FDA Commissioner Lester Crawford—not least because his appointment may indicate that the White House is finally making FDA reform a priority.
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Compulsory social responsibility
Martin Krause, Washington Times, 9-27-05

Price controls are always justified by reference to an apparent crisis—but once the price-control genie is let out of its bottle, government bureaucrats are likely to find an emergency everywhere they look. There is no better example of this mentality than in efforts by middle-class nations like Brazil to piggy-back on low-cost or free AIDS drugs offered by pharmaceutical companies to poverty-stricken African nations. This development, however, threatens industry incentives to create the next generations of AIDS medicines.
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Katrina's Victims Deserve Better than Medicaid
Nina Owcharenko, Heritage Foundation, 9-26-05

Owcharenko believes that the President and Congress should resist the temptation to expand the Medicaid entitlement to cover victims of Hurricane Katrina. Instead, she believes that the federal government should give states more flexibility in administering Medicaid benefits, offer generous health grants to reimburse providers, and direct premium subsidies to help hurricane survivors maintain their existing private health insurance coverage.
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The White House Is Right To Threaten a Veto on Drug Importation
Andrew Grossman, Heritage Foundation, 9-21-05

“Another year,” Grossman says, “another bill, and another attempt to legalize prescription drug importation.” Drug importation is seen by many Congressional proponents as a way to finesse drug prices: just import cheaper drugs from abroad without getting into the messy, and probably unwinnable, fight to impose price controls in the U.S. Grossman reminds us, however, that importation is just as much of a mirage as price controls.
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Research

Statins Reduce Fracture Risk in Men
Medscape, 9-26-05

Research on statins continues to reveal new uses for these relatively safe and powerful drugs. While their effect on reducing heart disease has been well documented, scientists continue to discover unexpected benefits from these medicines—so much so that some observers have been led to wonder, “should we put statins in the drinking water?”
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Medical Progress Today is published by the Center for Medical Progress at the Manhattan Institute for Policy Research.

For more information about Medical Progress Today, please contact the managing editor, Paul Howard, at phoward@manhattan-institute.org, or via telephone at 212.599.7000.

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In this week's issue:

SPOTLIGHT

Making the perfect the enemy of the good

NEWS

Report reignites debate over Medicare drug plan
Test Predicts Response to Cancer Drugs
Remicade May Prevent Surgery for Ulcerative Colitis Patients
New FDA chief wants to prepare agency to foster transformation in medicine
Many Insurers Set to Offer New Medicare Drug Plans
Experts: Counterfeit drugs becoming major health threat in Europe

COMMENTARY

The New Pill Isn't Always the Best Pill
Regime Change at the FDA
Compulsory social responsibility
Katrina's Victims Deserve Better than Medicaid
The White House Is Right To Threaten a Veto on Drug Importation

RESEARCH

Statins Reduce Fracture Risk in Men
Center for Medical Progress 
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