Medical Progress Today
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Volume 2, Number 44
December 9, 2005


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In the Spotlight

A Victim of Their Own Devices
Guidant’s problems should lead the FDA to rethink how it collects postmarket safety data.

Peter J. Pitts, Medical Progress Today, 12-8-05

Once again into the abyss of FDA reform. The issue at hand is the FDA’s continuing struggle with 21st century post-market surveillance—this time in the realm of medical technology. How can we make certain that crucial information on adverse events and mechanical problems is swiftly transmitted to the FDA and then acted on with equal alacrity? Or to be blunt, how can reform from within the FDA create a mindset that places post-approval information on par with pre-approval submissions among the medical technology community?
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News

Lawsuit shield pits unions against vaccine makers
The Hill, 12-6-05

Editor’s Notes:

The debate over liability protections for vaccine manufacturers is escalating. Healthcare unions are now objecting that such protections would make their members less likely to accept vaccinations in the event of a public-health emergency.
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DNA helping Lilly bank on future cures
Indianapolis Star, 1-5-05

Editor’s Notes:

Human beings share 99.9% of their DNA. The remaining .1% (in conjunction with various environmental influences) may hold the key to unlocking the origin of illnesses like Alzheimer’s and cancer, and explain why some cancer drugs only work in a handful of patients. Unlocking those mysteries is one reason companies like Eli Lilly are storing biological samples from thousands of patients in hopes that, over time, new tests that study and compare genes, proteins, and other molecular signatures of disease will allow the company to develop personalized medicines that are safer and more effective than traditional treatments.
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Commentary

Making Sense of Drug Safety
Henry Miller, M.S., M.D., Washington Times, 12-7-05

The next time your doctor prescribes a drug for you, try reading the “label” (package insert) that comes with it. You’ll find it a confusing, unhelpful mass of technical jargon that seems designed to prevent the transmission of helpful information.
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Growing and Collapsing
Grace-Marie Turner, National Review Online, 12-6-05

Turner argues that the people who are doing the most harm to Medicaid are those who are resisting needed reforms. As long as Medicaid pretends that it is a gold-plated program that can be all things to all people, it will short-change low-income Americans who rely on it for a safety net.
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WHO’s in Charge?
Philip Stevens, National Review Online, 12-2-05

Stevens registers his dismay that the agenda of the World Health Organization has been co-opted by non-governmental organizations (NGOs) whose social and political objectives do little to advance public health, and evince an outright hostility to market forces.
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Congress Got Something Right
David Gratzer, Wall Street Journal, 7-5-05

While is Congress is fretting over the complexity of the Medicare drug benefit, there is at least one program, Dr. Gratzer says, that they should take unabashed credit for: Health Savings Accounts.
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The Secret Truth: Parents Used to Accept Routine Vaccinations For Their Children Without a Second Thought.
Darshak Sanghavi, The Boston Globe, 4-5-05

Sanghavi has written a moving account of why parents of autistic children, frustrated and overwhelmed by this mysterious disease, have blamed childhood vaccines containing thimerosal, a preservative, for their children’s’ illness.
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Research

Risk of Death in Elderly Users of Conventional vs. Atypical Antipsychotic Medications
Philip S. Wang, M.D., et al., New England Journal of Medicine, 12-1-05

New drug candidates must meet daunting safety standards from both industry and the FDA, standards that weren’t applied to drugs approved 20 or 30 years ago. New drugs are also much more scrutinized by the media and consumer groups, who rush to publicize every new potential side effect. As a result, the public and policymakers may assume that older drugs are safer because experience has already revealed everything we need to know about their safety profiles.
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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

A Victim of Their Own Devices

NEWS

Lawsuit shield pits unions against vaccine makers
DNA helping Lilly bank on future cures

COMMENTARY

Making Sense of Drug Safety
Growing and Collapsing
WHO’s in Charge?
Congress Got Something Right
The Secret Truth: Parents Used to Accept Routine Vaccinations For Their Children Without a Second Thought.

RESEARCH

Risk of Death in Elderly Users of Conventional vs. Atypical Antipsychotic Medications
Center for Medical Progress 
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