Medical Progress Today
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Volume 3, Number 3
January 20, 2006


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In the Spotlight

FDA Shows Interest in 18th Century Presbyterian Minister
Bayesian statistics may help improve drug development

Derek Lowe, Medical Progress Today, 1-19-06

Not many ideas of 18th-century Presbyterian ministers attract the interest of the pharmaceutical industry. But the works of Rev. Thomas Bayes have improved greatly with age. The paper that made his name was published in 1763 (two years after his death), where he proposed a method to decide the likelihood of an event while taking into account one's prior knowledge of what might occur. This idea bounced around through the mathematical literature for the next century or two, but it fell out of favor in the 1930s with the advent of the statistical methods that have been used ever since. For decades, no one heard very much about Bayesian statistics at all. One reason for this was they're much more computationally demanding, which was a real handicap until fairly recently.
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News

FDA Issues New Rules For Drug Labels --- Move Is Designed to Clarify Safety Data For Patients and Physicians
Wall Street Journal, 1-19-06

Editor’s Notes:

The FDA has effected what may turn out to be one of its most important safety innovations in decades: labeling changes that make it easier for doctors and patients to read and understand the clinical benefits (and risks) of FDA-approved medicines. The new labeling format replaces an arcane system that was burdened with complicated jargon and buried critical information in pages of minutiae.
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Lawyers May Change Their Tactics in Drug Liability Cases
Wall Street Journal, 1-19-06

Editor’s Notes:

The FDA, as expected, has issued a new labeling rule that tries to preempt state tort claims, at least in certain cases. If effective—and there is some question about whether state courts will recognize the agency’s authority—it could cancel out much of the frivolous litigation that now handicaps the pharmaceutical industry.
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Earlier Drug Testing on Humans Okd
Los Angeles Times, 1-13-06

Editor’s Notes:

Only 1 in every 5,000 compounds investigated by pharmaceutical companies will ever become a marketed drug. This is a horrible attrition rate, not least of all because some compounds fail—very expensively—in human clinical trials, and the costs of those failed projects must be recouped in the price of the miniscule number of drugs that actually reach market.
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Commentary

New England Journal of Politics
Wall Street Journal, 1-16-06

The Journal takes issue with the New England Journal of Medicine for its Merck-bashing editorial last month.
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HilaryCare Returns
Wall Street Journal, 1-16-06

Maryland’s answer to rising health-care costs has been to pass union-backed legislation requiring that some large employers (read: Wal-Mart) put aside a set percentage of funds to buy health insurance for its employees. The Journal argues that this is not only wrong-headed, but penalizes companies that find innovative solutions to rising insurance costs. In short the legislation is part of a national, union-funded attempt to impose HilaryCare via state legislation.
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Keep Government Out
Daniel P. Kessler, R. Glenn Hubbard, John F. Cogan, AEI Online, 1-13-06

Hubbard, dean of the Columbia University Business School, and his co-authors argue that our health care debate is handicapped by the conventional wisdom that it’s a zero sum game.
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Research

Cutting Drug Copayments For Sicker Patients Can Cut Hospitalizations and Save Money
RAND Corporation, 1-11-06

RAND’s study found that, at least for cholesterol lowering drugs, lowering co-pays for medicine – thus making them more affordable for patients – could actually increase overall health-care savings.
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In this week's issue:

SPOTLIGHT

FDA Shows Interest in 18th Century Presbyterian Minister

NEWS

FDA Issues New Rules For Drug Labels --- Move Is Designed to Clarify Safety Data For Patients and Physicians
Lawyers May Change Their Tactics in Drug Liability Cases
Earlier Drug Testing on Humans Okd

COMMENTARY

New England Journal of Politics
HilaryCare Returns
Keep Government Out

RESEARCH

Cutting Drug Copayments For Sicker Patients Can Cut Hospitalizations and Save Money
Center for Medical Progress 
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