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Biotech / Medical : Ligand (LGND) Breakout! -- Ignore unavailable to you. Want to Upgrade?

To: Henry Niman who wrote (23742)	7/31/1998 10:47:00 AM
From: Machaon	Read Replies (1) \| Respond to of 32384

Henry, thanks for the link to the FDA article on "off label". I have copied a couple of items that I felt were kinda interesting: ================================================================== <<< U.S. District Judge Royce Lamberth struck down both (FDA) regulations ... Lamberth noted that, once a drug is approved by the FDA to treat a specific ailment, physicians are free to prescribe the medication for other uses. Citing a General Accounting Office report, Lamberth noted that 25 percent of cancer drugs were prescribed for off-label uses and 56 percent of cancer patients received at least one off-label medication. >>> =================================================================== This shows a significant use of "off label" medications, before the restrictive regulations were thrown out. ==================================================================== <<< Lamberth also rejected government arguments that the scientific information distributed at medical conferences would be misused by doctors. "A physician's livelihood depends on the ability to make accurate life and death decisions upon the scientific evidence before them," Lamberth ruled in a 54-page opinion. "They are certainly capable of critically evaluating journal articles or textbook reprints." The agency "exaggerates its overall place in the universe," Lamberth said, by "asserting that any and all scientific claims about the safety, effectiveness, contraindications, side effects, and the like regarding prescription drugs are preemptively untruthful or misleading until the FDA has had the opportunity to evaluate them." >>> =================================================================== So, a federal bureaucracy, the FDA, which is not trusted too much by the public, in turn has a distrust for American doctors. The FDA was saying "We, Big Brother, who may or may not have the expertise, time, or staffing, to judge the effective use of medication, want to take the decision out of the hands of the medical profession! Hats off to Judge Royce Lamberth! At any rate. This adds significantly to the credibility of Ligand's business plan, to develop drugs for small "fast track" markets, and then market them for large "off label" markets. Kudos to Ligand's management! Good luck, Bob