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Politics : PRESIDENT GEORGE W. BUSH -- Ignore unavailable to you. Want to Upgrade?

To: Hope Praytochange who wrote (681626)	5/5/2005 8:50:26 PM
From: TideGlider	Read Replies (1) \| Respond to of 769667

Internet Drugs Bad Medicine Matthew Herper, 05.23.05 Related Quotes PFE 27.85 + 0.02 TYPE= 0.00 + 0.00 5/5/05 4:01:00 PM ET Most Popular Stories Most Expensive Zip Codes Cash Rich And Dirt Cheap CEO Compensation Other Drugs To Watch Juniper Likely To Keep Making Niche Acquisitions Most Popular Videos Better Sex Diet How Billionaires Die Travel Like A Billionaire Million-Dollar Homes Most Expensive ZIP Codes More From Forbes.com Video Network The Internet is a marvelous mechanism for selling things--including things that are either illegal or just plain dangerous. The Drug Enforcement Administration called it Operation Cyber Chase. Between Apr. 18 and Apr. 20 federal agents made 20 arrests in five states, Costa Rica and three cities in India. Investigators allege that two Indian nationals, Brij Bhusan Bansal and Akhil Bansal, were running an international operation that sold repackaged anabolic steroids, narcotics and amphetamines made in India and other countries to Americans over the Web. Since 2003, investigators say, the Bansals' organization had been selling 2.5 million doses per month of drugs like Vicodin. The officials who busted this ring, which used e-mail spam to sell drugs, say the Bansals are only the beginning. There are tens of thousands of Web sites that sell prescription drugs of unknown origin to Americans illegally. "All you get is a plain brown envelope," says Jeffrey Kindler, Pfizer's vice chairman. Regulators and drug industry executives are pulling their hair out trying to stem a rising tide of fake or low-quality medicines being sold online. A Web site based in Canada may get its products from India or China, or may traffic in counterfeits. Earlier this year Pfizer executives were alerted to a batch of fake Lipitor when five patients saw their cholesterol skyrocket and to a counterfeit of the glaucoma drug Xalatan that contained mainly the antiseptic boric acid. But counterfeit operations are often small fly-by-night firms that operate out of shacks. An even bigger threat may come from Asia, Africa and Latin America, where relatively large drug firms make copycat pills that are legal in their own countries but fail to meet the standards of safety and efficacy that the U.S. applies to generic and branded drugs. Last year drug giant Eli Lilly enlisted the National Association of Boards of Pharmacy to take a look at Web sites that purported to sell "generic" versions of Lilly drugs. When the NABP investigators ordered Zyprexa, Lilly's top-selling antipsychotic, they got something called Telorzan, packaged in a cheap-looking blue box. When they ordered Evista, for osteoporosis, they received something called Fenilox. Orders for Cialis came back as Regalis or simply "generic" Cialis. These putative knockoffs, most produced in South and Central America, were sent to the Food & Drug Administration for analysis. None of them passed muster. Some Telorzan contained 17 times the level of impurities that would be expected in U.S. Zyprexa pills. The Fenilox didn't contain any active ingredient, meaning the drug wouldn't prevent bones from weakening and breaking. Like the Telorzan, the knockoff Cialis pills were rife with impurities, and the amount of active ingredient varied wildly. To David McAvoy, Lilly's U.S. director of regulatory policy, the drugs represented a familiar problem. For five years he served as Lilly's lead lawyer in Latin America, trying to defend the company's drug patents in countries that by and large do not respect intellectual property. He made the argument that the knock-offs weren't merely harming Lilly but could harm patients, too: Copycat pills coming from Mexico, Brazil and Argentina were substandard, made without any of the rigorous tests that ensure the safety of medicines in the U.S. In the past McAvoy convinced Mexican regulators to keep a copy of Evista, the osteoporosis drug, off the market by showing that it didn't dissolve properly. A similar line of attack kept a copycat of Gemzar, for cancer, off the Brazilian market. In that case the drug's molecular structure didn't match up with the branded version, changing its effectiveness. "Doesn't somebody in Mexico or Brazil deserve the same assurance of quality as someone in the U.S. or Europe?" asks Grey F. Warner, the senior vice president for Merck's human health division in Latin America. A similar investigation conducted by the FDA of drugs being sold on the Internet echoed Lilly's results. Copies of Viagra and Lipitor, both supposedly protected by worldwide patents, had 65% and 81%, respectively, of the normal amount of active ingredient. Not a single pill met U.S. manufacturing standards. The Ambien generics were as much as two times too strong. "If an elderly person took that they might not ever wake up again!" says William Hubbard, the FDA's recently retired head of policy and planning. A research paper by Merck and outside researchers showed that copies of Fosamax being sold in Latin American countries--in violation of Merck's patents--didn't dissolve properly. Depending on the pill, it might not work or it would worsen the drug's side effects, causing severe heartburn. Large pharmaceutical companies have a vested interest in portraying international generics as unsafe. It's a way for them to increase their market share in developing nations and, more importantly, it works to prevent cheaper drugs from being imported into lucrative North American and European markets. Sidebar forbes.com