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May 25, 2012

Rabbi Yonason Goldson: Thinking About Faith
Mark Clayton: Is Hillary's State Dept. hacking Al Qaeda? Not quite
David G. Savage: Supreme Court limits protection against double jeopardy
Ashley Powers: A nightmare, then conviction is tossed
Erika Bolstad: Temple cancels Wasserman Schultz speech
Deroy Murdock: WWII hero Karski to receive U.S. Medal of Freedom
Kimberly Lankford: Health Coverage for College Grads
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
Clifford D. May: What Iran's Rulers Want
Michael Muskal: 'Pro-choice' position hits record low, according to poll
Chris Farrell: Are We in a Tech Bubble?
Kimberly Lankford: Switching Medicare Advantage Plans Mid-Year
Bryan McIver, M.B., Ch.B., Ph.D.: Mayo Clinic Medical Edge: Understanding hyperthyroidism and its variety of treatment options
The Kosher Gourmet by Penelope Wall: PHILLY CHEESE STEAKS --- hold the steak!
May 23, 2012
Ex-CIA spy in Iran's Revolutionary Guard: Baghdad talks highlight Western naivete
Tony Pugh: More private colleges offering tuition discounts
Lisa Gerstner: 4 Money-Etiquette Questions Answered
Mary Beth Franklin: How to Choose the Right Annuity for You
Art Markman, Ph.D.: Get smart: How to bulk up your creativity muscles
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
David S. Cloud and Kathleen Hennessey: Obama changes mind on Pakistan invite to NATO summit --- and then gets dissed by country's president
Warren Richey: Can US group challenge overseas surveillance act? Supreme Court to decide
Thomas M. Anderson: Walking Away From a Mortgage
Environmental Nutrition editors: The lowdown on a low-acid diet
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
James K. Glassman: 5 Stock Picks Among Online Retailers
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
Caroline B. Glick: Embracing dangerous delusions and not our friends
Steven Goldberg: 5 Great Stock Picks and the Exchange-Traded Fund that Owns Them
Janet Bodnar: How to Teach Kids to Handle Credit Cards
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
Mary Beth Franklin: Retirement Savings Tips for New Grads
Amina Khan: Research links coffee to lower death rates
Chelsea Sheasley: Social media: Is it too feminine?
The Kosher Gourmet by Faith Duran : Cheesy Potato Breakfast Casserole with Cheddar and Sun-Dried Tomatoes
May 16, 2012
Jackson Holahan: The Aleppo Codex
Jonathan Tobin : Iran Declares Victory in Nuclear Talks
Anne Kates Smith: 7 Stocks That Let You Sleep Tight
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
Dennis Prager: God and Man at (and for) Liberty
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
Environmental Nutrition Editors: Get the facts on palm sugar sweetening
The Kosher Gourmet by Kathy Hunt: Spread a Little Excitement with EXOTIC CONDIMENTS (4 RECIPES)
May 14, 2012
Richard Simon: Purple Hearts for domestic terror victims?
Nando Pelusi, Ph.D.: The privacy paradox: Surrounded by strangers, we risk isolation, anxiety
Chris Farrell: Investing Lessons from the Great Recession
Lisa Gerstner: How to Protect Your Identity, Finances If You Lose Your Phone
Harvard Health Letters: Heart disease and dementia
Tiffany O'Callaghan: New hormone mimics effects of exercise without the sweat
The Kosher Gourmet by Megan Gordon: MANGO COCONUT OAT MORNING MUFFINS are a bright but hearty delight
May 11, 2012
Rabbi B. Shafier: Why happiness will always be elusive
Charles Krauthammer: Echoes of '67: Israel unites
Howard LaFranchi: With G8 snub, US-Putin 'reset' off to stumbling start
Jeremy J. Siegel: Investors, Relax About Rising Interest Rates
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
Clifford D. May: The Real Palestinian Refugee Problem
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
Harvard Health Letters: Palliative care: Underused therapy yields surprising benefits
Jeff Bertolucci: Get Home Phone Service for Less Than $10 a Month
Rachel L. Sheedy and Susan B. Garland : Make the Right Moves to Boost Benefits
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
John Rosemond: Parents, stop destroying the American male
Valerie J. Nelson: Maurice Sendak, author of 'Where the Wild Things Are,' dies at 83
Bob Frick: Angst Over Annuities
Sharon Palmer, R.D. How you can reduce your risk -- or delay -- chronic diseases associated with aging
Howard LeWine, M.D.: Ask the Harvard Experts: Why did my blood pressure suddenly shoot up?
Lisa Gerstner: Lower the Rate on All Your Loans
The Kosher Gourmet by Emily Ho : Springtime soba with miso sauce offers a coloful mix of fresh textures and flavors
May 8, 2012
Edmund Sanders: Netanyahu suddenly cancels new elections, forms unity government
Frank J. Gaffney Jr.: Farewell to European superstate
Anne Kates Smith: 4 Stocks That Mimic Buffett and Berkshire Hathaway
Gaia Vince and Clare Wilson The Rise of Miniature Medical Robots: Fantasy Fast Becoming Reality
Paul Takahashi, M.D.: Mayo Clinic Medical Edge: Never suffer night leg cramps
Jessica L. Anderson: Extended-Warranty Warning
The Kosher Gourmet by Diane Rossen Worthington: Celebrate National Chocolate Chip Day with the Best Cookie Ever (Includes techniques)
May 7, 2012
Mark Clayton: Homeland Security warns major cyber attack aimed at gas pipeline industry underway
Angus Roxburgh: Putin Decoded: World view of a Russian feeling dissed
Kimberly Lankford: Navigate a Course for Long-Term Care
Kevin McCormally How to Adjust Your Tax Withholding
Celeste Robb-Nicholson, M.D.: Harvard Health Letters: How do you treat a Baker's cyst?
Joanne Capano: Healthy Snacks for Children: The Choices May Surprise You
The Kosher Gourmet by Penelope Wall: Classic Creamy Spinach Dip with a Fraction of the Calories and Fat
May 4, 2012
Rabbi Nathan Lopes Cardozo: Holy 'trivialities'
Jonathan Tobin: Bibi v. Barak will be no contest this time around
Steven Goldberg: Blue Chip Stocks On Sale Worldwide
Art Pine Slow Productivity Growth a Blessing --- For Now
Sue Hubbard, M.D. : The Kid's Doctor: Are Kids Too Wired?
Kerri-Ann Jennings, M.S., R.D: Foods that are good for your smile
Amy Paturel, M.S., M.P.H.: Eating Well: Foods that are good for your smile
The Kosher Gourmet by Betty Rosbottom: Strawberry rhubarb parfaits are elegant yet simple to assemble
May 3, 2012
Michael Freund: Who's Afraid of the Messiah?
Clifford D. May: The Foggiest War
Susan B. Garland: Insurance to Cover Old Old Age
Steven Goldberg 6 Reasons to Bet on a Big Bull Market
Harvard Health Letters: Treating prostate cancer --- no rush to judgment
Larry Gordon: Harvard, MIT partner to offer free online courses
Naomi Nix : Man gets free trip to Chicago after postcard sent by mother in 1957 finally reaches him
The Kosher Gourmet by Diane Rossen Worthington: Intensely Italian vegetable frittata is a seriously simple standby


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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