Medical Progress Today
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Volume 4, Number 10
March 9, 2007


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News

New Generation of Stents Awaits FDA Approval
Wall Street Journal, 3-8-07

Editor's Notes:

As the FDA and physicians debate the relative risks of drug coated stents vs. bare metal stents, companies are already developing a new generation of coated stents that try to overcome safety concerns associated with previous models. But the FDA may slow the approval of new models until more data is available on the older models.
Continue reading . . .

Kennedy urges tough tests for generic biologic drugs
The Boston Globe, 3-7-07

Editor's Notes:

In the midst of a heated Congressional debate over rules that should govern a new process for approving so-called "biogenerics" (copycat versions of biotech drugs whose patents have expired), U.S. Senator Ted Kennedy (D-MA) has called for an approval process with strong safeguards, including new clinical testing.
Continue reading . . .

AARP: Prescription Drug Prices Up; Trade Group Calls AARP Report Inaccurate and Misleading
WebMD, 3-6-07

Editor's Notes:

Every quarter the AARP releases a study of prescription drug inflation—and every quarter it's misleading. The problem is that the AARP quotes list prices for drugs, which is not the true average price of the medicine. Pharmacy benefit managers, HMOs, hospitals, employers, seniors with Medicare drug coverage, etc. all receive their drugs at heavily discounted rates.
Continue reading . . .

Off label use common in kids
UPI, 3-5-07

Editor's Notes:

This article underscores how little we know about how drugs approved to treat adults are being used for children. Some experts estimate that about 15% of all prescription drugs are used off-label (i.e., for uses not officially approved by the FDA). For some uses, like oncology and pediatrics, the rate is much, much higher.
Continue reading . . .

Embattled FDA chief fights back
Houston Chronicle, 3-4-07

Editor's Notes:

The Chronicle interviews FDA Commissioner Andrew Von Eschenbach, who asks "How many cheerleaders have you seen on the streets for the FDA?" The Commissioner's point is well taken. Hindsight is 20/20, and it is always possible to second guess its regulatory decisions. As a result, the agency is always open to criticism, particularly on Capitol Hill.
Continue reading . . .

Report Blasts FDA's System to Track Drugs
Wall Street Journal, 3-3-07

Editor's Notes:

A consulting group has weighed in with a new report criticizing the FDA's current adverse even reporting system—a report that the FDA heavily disputes. What no one seems to argue, however, is that the FDA needs more funding to improve its current system.
Continue reading . . .

Commentary

Bangkok's Drug War Goes Global
Wall Street Journal, 3-7-07

The Journal warns that Thailand's recent move to seize drug patents is part of a larger assault on intellectual property that will chill the development of new medicines and hurt global health.
Continue reading . . .

40 Years Later, Still No Cure
Phyllis Richman, Washington Post, 3-7-07

Richman chronicles her struggles with Parkinson's disease, while also noting that new drug innovation is also affected by how vocal—and determined—patient disease groups are in putting pressure on industry and the FDA to approve new medicines.
Continue reading . . .

Prescription for Trouble
Dr. Scott Gottlieb, Wall Street Journal, 3-6-07

Gottlieb, a former Deputy Commissioner at the FDA, argues that the government is steadily encroaching on physician autonomy—with potentially dangerous consequences for patient care.
Continue reading . . .

Why I'm Fighting – The Health Care New York Needs
Eliot Spitzer, New York Post, 3-5-07

New York Governor Eliot Spitzer lays out his plan for health care reform, and criticizes the special interest groups that have driven up health care spending at the expense of patients.
Continue reading . . .

Medical Nihilism and the HPV Vaccine
Ivan Oransky, The Boston Globe, 3-4-07

Oransky voices his concern that, while the pharmaceutical industry is open to some well-deserved criticism, therapeutic "nihilists" have come to treat drugs as worse than the diseases they are meant to treat.
Continue reading . . .


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In this week's issue:

NEWS

New Generation of Stents Awaits FDA Approval
Kennedy urges tough tests for generic biologic drugs
AARP: Prescription Drug Prices Up; Trade Group Calls AARP Report Inaccurate and Misleading
Off label use common in kids
Embattled FDA chief fights back
Report Blasts FDA's System to Track Drugs

COMMENTARY

Bangkok's Drug War Goes Global
40 Years Later, Still No Cure
Prescription for Trouble
Why I'm Fighting – The Health Care New York Needs
Medical Nihilism and the HPV Vaccine

COMING SOON!!

New book by Regina Herzlinger: Who Killed Health Care: America's $1.5 Trillion Problem - and the Consumer-Driven Cure (McGraw-Hill, June 2007)

Advanced copies available now at Amazon

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