Talk:Kefauver–Harris Amendment

message: This article is part of a series of articles trying to provide additional information on several aspects of clinical development (trying to fill some gaps). Pvosta 12:55, 15 October 2006 (UTC)
thread_title: Untitled

message: I removed the criticism section.  This is hard to put succinctly, so I'll try for excess verbiage and hope my point gets across.  The Kefauver Harris Amendment was really what put the FDA on the map as a regulatory agency.  My experience with patient care is that people will tend to want to take a medication without regard to whether it actually does what it claims to do, and without regard to possible side effects.  This is just human nature.  Before the K-H Amendment, there really wasn't any part of society preventing manipulative, greedy people from taking advantage of that human tendency to seek medicine, and what happened was that probably thousands of people suffered needlessly from medicines that were harmful, and thousands more wasted good money on medicines that were completely useless.
I think overall there is a benefit to society by a set of laws that protect patients from false marketing.  In America, consumers implicitly assume that advertisements about medications are true, but this was not always the case.  The K-H Amendment really marked the first time that America made a commitment to trying to learn the truth about drugs through organized scientific research, and a commitment to trying to only speak the truth about drugs in advertising to doctors and patients.  America led the world in providing these safeguards to patients, and one can understand how the world is now a better place because we agree that scientific research is a good way to assess efficacy.
So to criticise the K-H Amendment on a page meant to give information is to really not understand the purpose of the Amendment or its place in history.  Sure, there are criticisms, but that's not really relevant to the subject.  One can say that the K-H Amendment provides such and such a budget to the FDA for NDA submission, or one can say that drug companies spend x number of dollars on clinical research mandated by the K-H Amendment, but saying that the K-H Amendment made drugs more expensive is like saying that airbags made cars needlessly expensive.  Drug development is a fundamentally different enterprise than it was in 1961, and that's a very good thing.--Dr.michael.benjamin 05:14, 23 March 2007 (UTC)
replies: text: False advertising is against the law with or without the Kefauver Harris Amendment. It's called fraud. Your airbag analogy works quite well, and I'll employ it myself. Sure an airbag saves lives, but it should be up to the individual whether he wants to pay more for an airbag. He should be allowed the freedom of choice to choose a lower price car with no airbag. Let people run their own lives. They don't need you to be their dictator. Regulations 16:00, 23 March 2007 (UTC)
replies: text: Bad analogy.  Better analogy: Some drugs are like a car that blows up when you turn the ignition key.  Consumers need some way to tell that the car won't blow up on them, just like they need some way to know that the drug they want to take is safe.  Left to their own devices, the drug companies won't do it themselves.  Without the required studies, consumers would have no way to tell whether a drug is safe or not.  If you don't like FDA regulations, call your congressman.  Wikipedia is not the place to tell the world about it.--Dr.michael.benjamin 05:27, 25 March 2007 (UTC)
replies: text: You don't even know what the Kefauver Harris Amendment is about. It's not to test for safety but for efficacy. Prior to the amendment, drugs only had to be certified by the FDA for safety. The Amendment required that drugs be certified for efficacy as well ("efficacy" means effectivness, which I'm guessing you probably didn't know). And yes, a consumer would still know if a drug was safe or not if the FDA permitted sale of drugs they didn't certify. The medicine would come with a label on it that said it had not been tested for safety by the FDA, or they would sign a form at the pharmacists consenting that they are aware of that. Regulations 17:11, 25 March 2007 (UTC)

text: It doesn't matter if you like the amendment or not. The criticism is real and it even comes from a Nobel prize winning economist, therefore it must be documented. Don't delete something just because you don't like it. Regulations 15:55, 23 March 2007 (UTC)
replies: text: I deleted it because it is not relevant, and is supported by references that have dates before the data in the text (how can you have data from 1998 if the reference is from 1985?) You'll have to come up with a better reference--the one in the text is garbage, leading me to suspect that the statement is just plain false.--Dr.michael.benjamin 07:22, 24 March 2007 (UTC)
replies: text: Can you be more specific? Which reference are you talking about? Regulations 18:10, 24 March 2007 (UTC)
thread_title: Criticism

message: The criticism section is essentially a duplication of edits that are being made at FDA#Criticism. They need to be in one place, not both. You can add a header saying "see also - FDA criticism", but rehashing the same articles and the same arguments is redundant and soapboxy. MastCell Talk 22:32, 29 March 2007 (UTC)
replies: text: Should not be moved to FDA. THis article needs a criticism specific to the Amendment. If a couple things are duplicated that's ok. People looking for information about this amendment online may never go to the FDA article. Wikipedia is full of duplicated information. We're not short on disk space. Regulations 02:59, 30 March 2007 (UTC)
replies: text: Again, it's not a matter of "space" in a literal sense. The problem is that your favorite criticisms are really criticisms of the FDA, not Kefauver-Harris per se. Repeating the same criticisms here and at FDA is redundant, smacks of an attempt to use Wikipedia as a soapbox, and gives them even more undue weight. People can be directed to the FDA article. MastCell Talk 04:24, 30 March 2007 (UTC)
thread_title:  Duplication