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May 25, 2012
Mark Clayton: Is Hillary's State Dept. hacking Al Qaeda? Not quite
Erika Bolstad: Temple cancels Wasserman Schultz speech
The Kosher Gourmet by Ethel G. Hofman: The former president of the International Association of Culinary Professionals, whose members included the likes of Julia Child, is back with contemporary Shavous cuisine: Ruby Fruit Soup, Sweet Noodle Kugel with Cheese, Key Lime Curd, Calsone Casserole Frittata with Wild Mushrooms, Sun-dried tomatoes and Olives, Baked Tilapia with Pepper Cheese Cream and Brown Sugar Shortbread
May 24, 2012
Jeff Jacoby: The peace process battered Israel's reputation
Michael Muskal: 'Pro-choice' position hits record low, according to poll
Chris Farrell: Are We in a Tech Bubble?
The Kosher Gourmet by Penelope Wall: PHILLY CHEESE STEAKS --- hold the steak!
May 23, 2012
Tony Pugh: More private colleges offering tuition discounts
Mary Beth Franklin: How to Choose the Right Annuity for You
Tina Susman: The wig wasn't enough: Man gets 13 years for posing as his dead mom
The Kosher Gourmet by Emma Christensen:A simple way to do fish right
May 22, 2012
Warren Richey: Can US group challenge overseas surveillance act? Supreme Court to decide
Thomas M. Anderson: Walking Away From a Mortgage
The Kosher Gourmet by Megan Gordon: Enjoy a celebration of the most rich and layered flavors: Black bean, sweet potato and quinoa chili
May 21, 2012
Mark Clayton: Cybersecurity: How US utilities passed up chance to protect their networks
Howard LaFranchi: NATO summit: Who will foot the bill for long-term Afghanistan security?
Chris Farrell : Earn Dividends in Emerging Markets with This WisdomTree ETF
Stephen Whiteside, Ph.D. : Mayo Clinic Medical Edge: Social anxiety disorder --- or just shy?
Guy Jackson : Victim's father regrets death of Lockerbie bomber
The Kosher Gourmet by Mario Batali: Famed chef's veal shoulder farsumagru: A festive meat course for late spring
May 18, 2012
Rabbi Berel Wein: Striving: The People of the Book's Book for (All of) the People
Steven Goldberg: 5 Great Stock Picks and the Exchange-Traded Fund that Owns Them
Mary Pickett, M.D.: Ask the Harvard Experts: Don't be forced into gluten-free lifestyle based merely on a doctor's false-positive test
The Kosher Gourmet by Carolyn Malcoun: DIY healthy lunchbox treats: HOMEMADE FRUIT BARS for kids and brown-bagging adults alike
May 17, 2012
Warren Richey: Teacher fired for being unwed and pregnant can sue religious school, court rules
Josh Mitnick: Netanyahu's 'centrist' coalition is already proving it's anything but
Steven Goldberg: Earn Dividends in Emerging Markets with This WisdomTree ETF
Amina Khan: Research links coffee to lower death rates
The Kosher Gourmet by Faith Duran : Cheesy Potato Breakfast Casserole with Cheddar and Sun-Dried Tomatoes
May 16, 2012
Carmen Terzic, M.D., Ph.D. : Mayo Clinic Medical Edge: A variety of exercises can help improve balance
Melissa Healy: National strategy on Alzheimer's disease aims to halt it by 2025
The Kosher Gourmet by Joyce White : GOODNESS GRACIOUS: GREENS! 4 winning recipes that are no longer just for down-home folks (Includes expert tips & techniques)
May 15, 2012
Kristen Chick: Obama administration resumes arms sales to Bahrain despite serious unresolved human rights issues. Activists feel abandoned
Pat Mertz Esswein: Homes are now affordable again and mortgage rates are low. What you need to know before you buy
Kathy Kristof: Our Practical Investor Fights Inflation with These 6 Investments
Sue Hubbard, M.D.: The Kid's Doctor: Lactose intolerant young child? Check again
The Kosher Gourmet by Kathy Hunt: Spread a Little Excitement with EXOTIC CONDIMENTS (4 RECIPES)
May 14, 2012
Lisa Gerstner: How to Protect Your Identity, Finances If You Lose Your Phone
Harvard Health Letters: Heart disease and dementia
The Kosher Gourmet by Megan Gordon: MANGO COCONUT OAT MORNING MUFFINS are a bright but hearty delight
May 11, 2012
Jessica L. Anderson: Get the Best Deal on a Used Car
Jett Stone: Forget face-lifts and fake knees. Scientists have seen the fountain of youth --- and it's broccoli
The Kosher Gourmet by Chef Mario Batali: The famed chef's vegetable dish that tastes true to the season: FAVAS AND SUGAR SNAP PEAS WITH POTATOES AND TARRAGON
May 10, 2012
Sergei L. Loiko: Putin sends warning to U.S., NATO in Victory Day speech at Red Square
Mary Rourke: How being a 'mentch' got Vidal Sasoon his start and fighting in Israel's War of Independence provided him with confidence and a strong sense of his own identity
Jeff Bertolucci: Get Home Phone Service for Less Than $10 a Month
The Kosher Gourmet by Betty Rosbottom: Gleaming with its golden, crimson, and snowy white hues, this silken smooth and creamy STRAWBERRY ORANGE TRIFLE looks impressive, but is easy to prepare
May 9, 2012
Sharon Palmer, R.D. How you can reduce your risk -- or delay -- chronic diseases associated with aging
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Jewish World Review
May 30, 2007
/ 13 Sivan, 5767
FDA: Friend or Foe?
By
Walter Williams
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http://www.JewishWorldReview.com |
The U.S. Food and Drug Administration (FDA) is charged with ensuring that only safe and effective drugs are marketed. Such a task is highly complex and fraught with difficulties. Consumers, the ostensible beneficiaries, should examine and question the incentive structure that FDA officials face.
Some drugs are highly beneficial to certain patients but pose an unacceptable risk to others. Vioxx along with Celebrex are in a class of non-steroidal anti-inflammatory drugs (NSAID) known as COX-2 inhibitors. Salicylates, such as aspirin, are a subset of such drugs. COX-2 inhibitors are sometimes prescribed to adult patients for management of acute pain associated with osteoarthritis. Vioxx, since removed from the market, was very beneficial to patients who suffered from stomach bleeding and ulcers when they took other NSAIDs. For other adults, Vioxx presented an increased risk of a stroke or a life-threatening cardiovascular event.
So if you're an FDA official, what are your incentives in terms of whether to approve or disapprove the marketing of a drug that has a tremendous benefit to some patients and poses a health threat to others? Former FDA Commissioner Alexander Schmidt hinted at the answer when he said, "In all our FDA history, we are unable to find a single instance where a Congressional committee investigated the failure of FDA to approve a new drug. But the times when hearings have been held to criticize our approval of a new drug have been so frequent that we have not been able to count them. The message to FDA staff could not be clearer."
There's little or no cost to the FDA for not approving a drug that might be safe, effective and clinically superior to other drugs for some patients but pose a risk for others. My question to FDA officials is: Should a drug be disapproved whenever it poses a health risk to some people but a benefit to others? To do so would eliminate most drugs, including aspirin, because all drugs pose a health risk to some people.
According to the May 17th edition of The Wall Street Journal, in an editorial, "Our Lawless FDA," by Hoover Institution scholars Drs. David Henderson and Charles Hooper, the FDA recently rejected Arcoxia, a new COX-2 inhibitor from Merck. In explaining the FDA's disapproval, Robert Meyer, director of the agency's Office of Drug Evaluation, told reporters that "simply having another drug on the market" wasn't "sufficient reason to approve the product unless there was a unique role defined."
Henderson and Hooper argue that this position greatly exceeds the FDA's mandate to determine a drug's safety and effectiveness. Arcoxia has been tested on over 34,000 U.S. patients. Moreover, it has been approved for use in England, Germany and 61 other countries in Asia, Latin America and Europe. Meyer's explanation is nothing less than fascist arrogance.
According to the FDA's literature, its mandate is: "Once a new drug application is filed, an FDA review team medical doctors, chemists, statisticians, microbiologists, pharmacologists, and other experts evaluates whether the studies the sponsor submitted show that the drug is safe and effective for its proposed use." Nothing in the FDA mandate requires that a drug has to be better than what's currently available in order to win approval.
Henderson and Hooper argue that in the worst-case scenario where Arcoxia is no better than existing drugs, it would compete with those drugs. Two centuries of economic theory and evidence show that competition is good. A new drug that competes with existing drugs would moderate drug prices and cause competitors to stay on their toes.
While Henderson and Hooper don't say it, I smell a rat. Arcoxia is produced by Merck, which has several major competitors in the COX-2 inhibitor market. Some scientists on the FDA's advisory panel have paid affiliations with companies who'd benefit from less competition.
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