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Volume 7, Number 24
June 17, 2010


In the Spotlight

FDA Is Slowing Down Necessary Drugs and Treatments

Paul Howard, Washington Examiner, 6-17-10

For those looking for fresh evidence that companies and physicians are pushing cancer treatment into new frontiers, look no further than last week's annual American Society of Clinical Oncology meeting in Chicago. A new treatment designed to attack genetic abnormalities in a subset of lung cancer patients shrank or stabilized tumors in about 90 percent of patients in one study. Another clinical trial for a drug designed to boost the immune system extended survival for patients with melanoma, a deadly form of skin cancer that—unless it's caught early—is quickly fatal. Without a doubt, enormous public and private investments into the genetic causes of chronic disease are producing effective new treatments.
Continue reading . . .


· Medical Device Recalls and the FDA Approval Process, Zuckerman, D. M., Brown, P., Nissen, S. E., Archives of Internal Medicine, 6-14-11
· Patent Reform Gets Key Support in House, Julian Pecquet, The Hill, 6-14-11
· $4.3 Billion Pledged at Vaccine Fund-Raiser, Donald G. McNeil Jr., New York Times, 6-13-2011
· Physicians Leaving Practices for health System Employment, Karen Cheung, FierceHealthcare, 6-13-11

More Headlines >>


· Marco Rubio takes on 'Medi-scare' Marc A. Thiessen, Washington Post, 6-13-11
· 'Vouchercare' Is the Right Name for Medicare Laurence Kotlikoff, Bloomberg, 6-15-11
· Built To Fail: Health Insurance Exchanges Under The Affordable Care Act
· Can Exchanges Help Consumers Get Good Value Insurance? Depends On Where You Live Sabrina Corlette, Kaiser Health News, 6-15-11
· The ObamaCare Bad News Continues Karl Rove, Wall Street Journal, 6-16-11
· ObamaCare's Economic Flaws Doug Holtz-Eakin, Investor's Business Daily, 6-8-11

More Commentary >>


· Why States Are So Miffed about Medicaid — Economics, Politics, and the "Woodwork Effect", Benjamin D. Sommers et al., New England Journal of Medicine, 6-15-11
· Auditing Access to Specialty Care for Children with Public Insurance, Joanna bisgaier et al., New England Journal of Medicine, 6-16-11
· Moving Beyond Fee-For-Service: The Case for Managed Care in Medicaid, Michael Ramlet and Carey Lafferty, American Action Forum, 6-14-11
· The New Gold Rush: Prospectors are Hoping to Mine Opportunities in the Healthcare Industry, Health Research Institute, PricewatershouseCoopers, 6-14-11
· Active Purchasing for Health Insurance Exchanges: An Analysis of Options, Sabrina Corlette and JoAnn Volk, RWJF, 6-14-11

More Research>>

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FDA Is Slowing Down Necessary Drugs and Treatments

Cost of Caution: The Impact on Patients of Delayed Drug Approvals
By Tomas J. Philipson and Eric Sun

The FDA's lengthy pre-application process for new drugs slows access to new treatments. For the first time ever, authors Tomas Philipson and Eric Sun calculate the costs of patients' lives lost to drug-development delays.

Podcast Series

Raymond L. Woosley is founder, president, and CEO of the Critical Path Institute (C-Path), an independent, non-profit organization uniquely dedicated to implementing the FDA's Critical Path Initiative. He has served as President of the American Society for Clinical Pharmacology and Therapeutics and the Association for Medical School Pharmacology Chairs. In this episode, Dr. Woosley discusses how advances in new sciences, like genomics, require new drug development tools and public-private collaborations to bring safer and more effective medicines to market. He also discusses C-Path’s groundbreaking work in support of the FDA's Critical Path Initiative.

Click here to listen to the podcast.

"Some place where the industry and the regulators and the patients can come together, . . . where these pre-competitive, applied science challenges can be met, is missing right now. We're all doing very good work, but it needs to be increased and it needs to be coordinated."
—Raymond L. Woosley


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