Dec. 1, 2008 Max Freidlander, as told to Jacklyn C. Wadler: India Inkings Mark Steyn: Whodunit!? Nov. 28, 2008 Rabbi Ahron Rapps: An evil seed that didn't have to be Melanie Phillips: Carpe diem --- or can we all relax now? Nov. 26, 2008 Michael Feldberg: Meet the Orthodox Jew who laid groundwork for scientific development of ordnance that undergirds America's current world leadership Andrea Simantov: Shades of life Nov. 25, 2008 The Jewish Ethicist by Rabbi Dr. Asher Meir : Getting Emotional For Influence The Kosher Gourmet by Ethel G. Hofman : Thanksiving feast! Nov. 24, 2008 Rabbi S. Binyomin Ginsberg: 'I just Became a grandchild!' Barry Rubin: Don't flatter your enemies, protect your friends Nov. 21, 2008 Rabbi A. Henach Leibowitz: Money matters? Caroline B. Glick: Civilization walks the plank Nov. 20, 2008 Rabbi Avi Shafran: Bronfman's blindness The Kosher Gourmet By Linda Gassenheimer: Portobellos add a hearty flavor to pasta with pesto Nov, 19, 2008 The Jewish Ethicist by Rabbi Dr. Asher Meir : Spread the wealth? Jewish tradition and income equality Elliot B. Gertel: 'Mad Men': Tackling prejudices or reinforcing them? Nov, 18, 2008 Dr. Debby Schwarz Hirschhorn: The End of the Age of Reason Jonathan Tobin: Does Barack + Bibi = Disaster? Nov, 17, 2008 Rabbi Yonason Goldson: The End of the Age of Reason Diana West: Gulling Americans into making terror legit? Nov, 14, 2008 Rabbi A. Henach Leibowitz: The Power of Spiritual Inertia Caroline B. Glick: The perils ahead Nov, 13, 2008 Stratfor Intelligence Briefing: How Bush and Obama together could change the Middle East dynamic The Kosher Gourmet by JeanMarie Brownson: Sweet and savory, crispy and meltingly tender bestilla Nov, 12, 2008 The Jewish Ethicist by Rabbi Dr. Asher Meir : Tyrannical Co-Workers Michael Doyle: High Court to consider today donated monuments that may have religious messages in public parks Nov, 11, 2008 Frank J. Gaffney, Jr.: Will Obama stop government officials considering institutionalizing financial jihad? Jonathan Tobin: They Will Decide Their Own Fate Nov, 10, 2008 Rabbi Avi Shafran: $8 billion, modern-day Tower of Babel being built? Barry Rubin: A letter to the president-elect from a Middle East realist Nov, 7, 2008 Rabbi Francis Nataf: Of Children and Immortality Caroline B. Glick: Livni's Obama strategy Nov, 6, 2008 Rabbi Yonason Goldson: How I tricked a classroom of apathetic students into grasping the fallacy of moral relativism The Kosher Gourmet By Gina Kim: Tips for making the perfect soup --- includes recipes Nov, 5, 2008 The Jewish Ethicist By Rabbi Dr. Asher Meir: Destitute Debtors Bruce Weinstein: 'Religulos': Bad title,even worse movie Nov, 4, 2008 Frank J. Gaffney, Jr.: Treasury Dept. submits to Shariah law Frida Ghitis: A surprise for Obama in the Middle East Nov, 3, 2008 Jonathan Rosenblum: Who says Jews are Smart? Jonathan Tobin: Was He Wrong About Everything? March 22, 2007 J-Rhythms with Avraham Rosenblum: JWR's cutting-edge music program showcasing performers -- singers, song writers, musicians, and bands -- who learn and live the Torah lifestyle (OUR NEWEST IGODCAST !) Oct. 29, 2003 Mortimer B. Zuckerman: Graffiti On History's Walls (MUST-READ!)

Jewish World Review June 16, 2005 / 9 Sivan, 5765 The FDA: Safety, Efficacy, Both or Neither? By Drs. Michael A. Glueck & Robert J. Cihak http://www.JewishWorldReview.com | A century or so ago, America noticed that, although life was getting better, it was also getting more complicated. Science and technology were churning out ideas and products as beneficial as they were incomprehensible. When advance came to seem inseparable from bigness — corporate bigness — a quaint, earnest breed of Americans known as Progressives decided that the way to simplify things was to get the government involved. And thus arose the regulatory apparatus that today controls, or tries to control, nearly every aspect of our lives. In the beginning, this was not necessarily bad. It was not bad because government and law also operated on the "reasonable man" principle: the average American, although perhaps ignorant of the finer points of science, technology and business, was nonetheless capable of making his own decisions, looking out for his own interests and generally behaving in a rational manner. Today, the guiding principle is that people are either idiots or raptors, either victims or (especially when organized into businesses) victimizers. Either way, America requires ever more micro-management, for its own good. Today, this philosophy is failing in the classic manner of any belief that, when applied to reality, doesn't work. It is also failing because the evils of regulation now outweigh the benefits. Current example: the Food and Drug Administration's power to ban drugs until, after long and expensive trials, they are proven safe and effective. Two aspects, please note. Safe and effective. Safety is not an absolute. Nothing is ever totally safe; as your Medicine Men love to point out, it all depends on the dosage and the usage. Safety must be balanced against gain. What does safety mean to a person with AIDS or terminal cancer or chronic, debilitating pain? And what might constitute acceptable risk for one person may prove horrific for another. Yet the FDA acts as though safety were some sort of absolute, and withholds its imprimatur for years and decades from drugs whose benefits, although risky, are proven in other countries, or yanks its approval from established drugs at the slightest whiff of long-term effects. Nor is effectiveness an absolute. Everything depends on the complex interactions of patient, condition, circumstance and environment. Why set absurdly high standards, which often take years and decades to prove, at the cost of human lives and human suffering? And while we're on the subject of money — how many worthwhile drugs never make it to market because the manufacturers can't or won't pay for the studies. Yes, it's almost always the manufacturers who pay. But if the FDA has reached the point where it's likely doing more harm than good, how to alter or abolish it? There are several possibilities. One is privatization, in effect letting an organization or organizations akin to Consumer Reports or Underwriters Laboratories do the studies, while depending on the good old-fashioned rationality of doctors and patients to use the information. Another is to let the FDA certify safety and effectiveness, but permit uncertified drugs to be sold, subject to the standard criminal penalties for fraud and related offenses. Yet another is to have the FDA study safety only. Your Medicine Men prefer another approach. The FDA should be tuned into a private corporation (actually, a consortium), funded by a combination of federal appropriations, corporate and other membership dues, and fees for service. Drugs should be evaluated on the basis of safety and effectiveness trade-offs and ranked in tiers, with only the clearly worthless and dangerous prohibited. All else should be available, subject to warning such as: "Benefits not proven in all cases, but zillions of people swear by it. Side effects are generally mild and may include death, impotence, baldness, loss of teeth, delusions of grandeur and a sense of levitation, in some cases accompanied by the reality. Before taking this or any medication, consult your nearest trial lawyer, bureaucrat or politician." Editor's Note: Michael Arnold Glueck, M.D., penned this week's commentary. Every weekday JewishWorldReview.com publishes what many in in the media and Washington consider "must-reading". Sign up for the daily JWR update. It's free. Just click here. Michael Arnold Glueck, M.D., is a multiple award winning writer who comments on medical-legal issues. Robert J. Cihak, M.D., is a Discovery Institute Senior Fellow and a past president of the Association of American Physicians and Surgeons. Both JWR contributors are Harvard trained diagnostic radiologists. Comment by clicking here. Archives © 2005,

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