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Biotech / Medical : VD's Model Portfolio & Discussion Thread -- Ignore unavailable to you. Want to Upgrade?

To: nigel bates who wrote (8611)	2/2/2001 6:31:08 PM
From: jayhawk969	Read Replies (1) \| Respond to of 9719

A decent editorial rom todays WSJ A 21st Century FDA Sometime soon President Bush, or perhaps new HHS Secretary Tommy Thompson, is going to have to pick someone new to run the Food and Drug Administration. Here's a real chance for compassionate conservatism to show its face. No greater opportunity exists to do good for all Americans than to rationalize the current, costly and archaic system of drug regulation in the U.S. It is ironic to think that one of the biggest battles inside the Beltway is over access to prescription drugs. The subject sends pulses racing in opinion polls, which explains why Democrats this week cranked up a bit of outrage over creating a prescription drug benefit. Meanwhile, out on the edge of the Beltway and beyond the melodrama sits the Food and Drug Administration. When a pharmaceutical company shows up at the FDA with an idea to make one of those wonder drugs that we all have a right to receive, the FDA says to the company: No problem; spend $500 million, test it for 10 years and we'll think about it. That prescription drug benefit isn't going to be worth much if the last century's regulations stifles the 21st century's scientific innovators. Three problems exist. Two are attributable to the FDA and one to the hallowed American tradition of stagecoach robbing, known now as class-action plaintiffs suits. Lawyers first. A few days ago, the New York Times science section carried an interesting article about a drug to treat irritable bowel syndrome, called Lotronex, which sufferers call a miracle drug and which the FDA has just removed from the market because 70 people had bad experiences with it. Sidney Wolfe of the Naderite Public Citizen wants it banned. Adjacent to the Times article was an ad by the law firm of Ronemus & Vilensky, soliciting Lotronex users to "file a claim against the manufacturer and collect significant compensation." The lawyers' specialty is artificially jacking up costs and depriving patients of access to medicine. Recall the silicone-implant litigation fiasco. Or the fate of the invaluable pregnancy morning-sickness drug, Bendectin, which has been off the market since 1983 because of lawsuits. This won't stop until President Bush introduces tort reform. As to the FDA itself, no one yet has found a solution to its institutional compulsion to restrict and suppress. It has three times ordered Pfizer and Pharmacia to cease TV ads for allegedly misstating the benefits of its arthritis drug Celebrex in which old people are seen scooter-riding. Obviously the oldster grapevine would declare Celebrex a dud, were that true, without the FDA's ludicrous overreaching. The agency recently has tried to regulate Internet drug sales, banned a cold ingredient that had been in use for 50 years, forced hospitals to now file paperwork for secondary use of medical devices, and tried to extend its sway over supplements, with similar absurdities over which claims are OK and which aren't. All the while they wail on Capitol Hill about health costs as if they dropped from the sky. But no greater service could be done by our political leaders than to address the excessive costs generated by the FDA's approval model. As Dr. Robert K. Oldham explains in the columns nearby, we have arrived at a point of significant imbalance between the genius of American medical science and the current regulatory system. Molecular biology is unraveling the mysteries of the human genome, raising the possibility that therapies can be tailored to individuals. But scientists and entrepreneurs working on this frontier are acutely aware that the FDA's staggering economics, atop those of the drug industry, are an insurmountable hurdle. Most people think the FDA exists to protect them from pharmaceutical dangers. But safety is resolved in the first of three required phases for drug approval, and it is relatively inexpensive to prove. Most of that $0.5 billion is spent proving "efficacy," that a drug will perform as claimed, using massive, placebo-controlled clinical trials. This crude massiveness, with its indefensibly high cost, is increasingly inappropriate to the scientific and economic realities of modern drug discovery and needs to be rethought. Back in the 1980s, Dr. Oldham tried to circumvent many of these impediments with a firm called Biotherapeutics, which let patients pay privately for cancer therapies based on this new science. Dr. Oldham may have been ahead of his time, but successor companies today are trying to bring these benefits to patients. This newspaper described some of these innovators in late 1999 ("Tailor-Made Vaccines Against Cancer Show Promise in Early Trials," 11/18/99). But as the article noted, the vaccines' inherent science, designed for the particularities of an individual's tumor, means "their developers might never standardize manufacturing practices enough to satisfy Food and Drug Administration regulators." The Bush folks would do well to talk to someone who understands these realities. Then put someone like that in charge of reforming the FDA.