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Medical Forum / General / Nutrition / June 2005FDA official: Safety system broken down
http://news.webindia123.com/news/showdetails.asp?id=87128&cat=Science FDA official: Safety system broken down:- WASHINGTON | June 09, 2005 7:11:28 PM IST A top U.S. Food and Drug Administration official says much still remains to be done by the government to uncover the dangers in drugs already on the market. The warning was issued to a medical advisory board in Washington by Dr. Janet Woodcock, FDA's deputy commissioner of operations, the New York Times reported Thursday. Woodcock, who has been asked to suggest safety improvements because of recent well-publicized drug industry troubles, said the government's safety system needs to be fixed, the report said. The keystone of the current system is the prescriber and that person is the one who decides if the benefits of a drug outweigh the risks for that patient, Woodcock said. This system has obviously broken down to some extent, as far as the fully informed provider and the fully informed patient. She said one way for the FDA to resolve problems with drugs on the market is to take advantage of electronic health records from managed-care organizations. She also said physician and hospital errors are major contributors to the current problem. ------- TC >>The keystone of the current system is the prescriber and that person is the one who decides if the benefits of a drug outweigh the risks for that patient, Woodcock said.<< COMMENT: Woodcock is wrong. The FDA makes such a decission long before the drug even becomes available to provider and patient, and does it without knowing the patient, and without suffering the patient's problems. And that IS the problem. SBH > >>The keystone of the current system is the prescriber and that person is > the one who decides if the benefits of a drug outweigh the risks for [quoted text clipped - 8 lines] > > SBH You are obviously correct Steve on the first part. Efficacy must be proven and safety must be proven for FDA approval before any doctor or patient sees it unless involved in a clinical trial. Insurance companies will not pay for the drug otherwise as far as I am aware of. If such approval did not exist then the patient would have to pay for it out of pocket and if that were to happen the price for the drug would actually go down I believe. The FDA and drug companies work together for obvious reasons. If the FDA weren't there the drug companies would invent their own so called independent body giving the blue seal of approval that they can market as "safe" and "effective". It provides relative safety for the patient and a marketing device for the drug manufacturers. > > >>The keystone of the current system is the prescriber and that person is > > the one who decides if the benefits of a drug outweigh the risks for [quoted text clipped - 22 lines] > It provides relative safety for the patient and a marketing device for the > drug manufacturers. There's the rub: "relative safety". Your idea of relative safety is not the same as my idea of relative safety which is not the same as Pharma's idea of relative safety which is not the same as the FDA's idea of relative safety which is not the same as patients' idea of relative safety which is not the same as..... TC >> >>The keystone of the current system is the prescriber and that person is >> the one who decides if the benefits of a drug outweigh the risks for [quoted text clipped - 16 lines] > aware > of. Many insurance companies pay for chiropractic, naturopathy and other conjecture-based mediciations. The also pay for medications that are technically not medically necessary, like Viagra and Levetra. Also, the insurance companies don't always pay for drugs that are FDA approved, especially if there is a similar one already on their formulary. > If such approval did not exist then the patient would have to pay for it > out of pocket and if that were to happen the price for the drug would > actually go down I believe. Actually, unless a drug is approved by the FDA, it cannot be sold as a drug for humans or other animals. > The FDA and drug companies work together for obvious reasons. If the FDA > weren't there the drug companies would invent their own so called > independent body giving the blue seal of approval that they can market as > "safe" and "effective". Actually, food supplements (think conjecture-based medicine, aka alternative medicine) can be marketed as safe and effective if they have been proven to be safe and effective. > It provides relative safety for the patient and a marketing device for the > drug manufacturers. Jeff > >> >>The keystone of the current system is the prescriber and that person is > >> the one who decides if the benefits of a drug outweigh the risks for [quoted text clipped - 19 lines] > Many insurance companies pay for chiropractic, naturopathy and other > conjecture-based mediciations. That's correct Jeff. The reason behind that is most back pain gets better on it's own and rather than seeing a medical specialist which costs much more they have found it cheaper to tell them to go to alternate care. The also pay for medications that are > technically not medically necessary, like Viagra and Levetra. That's correct but those are FDA approved and are very expensive. Naturopathy is much more cheaper including tiger penis soup or rhino testicles. > Also, the insurance companies don't always pay for drugs that are FDA > approved, especially if there is a similar one already on their formulary. They certainly wouldn't pay for a non FDA aprroved drug including research drugs. There are many statins, blood pressure meds etc on the market that most of the time they will pay. Some insurance don't want to pay for newer drugs sometimes like Medicare. > > If such approval did not exist then the patient would have to pay for it > > out of pocket and if that were to happen the price for the drug would > > actually go down I believe. > > Actually, unless a drug is approved by the FDA, it cannot be sold as a drug > for humans or other animals. Drugs sold in Canada are cheaper. People are buying viagra from Pakistan. Just give them a credit card number. I was giving a scenario in which the FDA were to be abolished then the drug companies would set up their own organization because drugs would flood the market and prices would go down. > > The FDA and drug companies work together for obvious reasons. If the FDA > > weren't there the drug companies would invent their own so called [quoted text clipped - 4 lines] > medicine) can be marketed as safe and effective if they have been proven to > be safe and effective. That's why they do it is to advertise that it is FDA approved. It is solely a marketing ploy as they don't need to do that. > > It provides relative safety for the patient and a marketing device for the > > drug manufacturers. > > Jeff |
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