| Home | Drugs Get Smart This was the title of an article in the September 5, 2005 issue of Business Week magazine. A year ago last June my wife had an adverse reaction to a prescription drug. She joined the 2.2 million Americans who suffer adverse reactions each year. Over 100,000 of them die. While my wife did not die, over a year later she has still not recovered and remains severely impaired. Recently the giant drug-company Roche has marketed a device called the AMPLICHIP, which gauges the genetic response to medications. Had this been available and used my wife would not have had the reaction. All 4 of my wife's sisters are adversely affect by the same class of drugs which is probably caused by too little of drug metabolizing enzymes in her liver. Unfortunately for the drug companies that would mean 2.2 million fewer prescriptions being prescribed. When four years ago top FDA official Dr. Janet Woodcock met with drug industry officials to discuss the promise of this kind ‘personalized medicine’ people stood up and said: "we are terrified." Targeted drugs can mean smaller markets for drugs and drug companies would have to prove the drug is proper in order to win FDA approval. On the plus side for the drug companies it would prevent fiascoes such as the VIOXX disaster. If Merck goes bankrupt from all the suits, the other companies might think it is a good idea after all. Pairing drugs and diagnostics together would also speed up and simplify FDA approval. Of course you will have to get doctors to use the tests which are expensive. The FDA has no authority over doctors and their track record of paying attention to the FDA instead of the drug salesmen bearing gifts is poor. The FDA told doctors to monitor liver function of diabetics taking the drug Rezulin; few did, so the FDA took it off the market after patients continued to die. One bright spot is that oncologists are now pairing diagnostics with drugs and companies such as Novartis and Genentech are cooperating. Most doctors are conscientious and they and the patients will demand their HMO do the personalized diagnostics. I AM HOPEFUL! |