Talk:Kefauver Harris Amendment

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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)


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)

So why not beef up the main part of the article by adding details about the regulatory impact of the Amendment, instead of trying to break it down with a weak criticism section. --Dr.michael.benjamin 05:15, 23 March 2007 (UTC)

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)
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)
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)

The amendment is a rare example of government working well, doing what it is supposed to do. In a representative democracy, one hopes that the elected representatives will take a rational approach to matters that affect society, like drug marketing.--Dr.michael.benjamin 05:25, 23 March 2007 (UTC)

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)

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)
Can you be more specific? Which reference are you talking about? Regulations 18:10, 24 March 2007 (UTC)

Drug development costs do not affect drug prices[edit]

It's counterintuitive, but is relies on very sound and fundamental economic logic. Drug development costs are sunk, meaning that they are a one-time cost which does not affect the ongoing decision of how to price drugs to achieve maximum profits. In the case of patented monopoly drugs, the only factor which affects the price of the drug is the price point at which sales volume x price reaches a maximum (the "maximum price the market will bear"). It might have cost $2 or $2 billion dollars to develop the drug, but this equation is no different. Chicken is the best way to not get the rest in your butt bro so dont be actin foul. drug - if future development costs exceed estimated future profits, they will not develop the drug, otherwise, they will.

And no, Reg, I don't care what a "Nobel prize-winning economist" says in a popular press article - unless you provide me with a paper of his in which he explains his logic-defying analysis, I am going to flat out say he is wrong. -Rustavo 04:54, 26 March 2007 (UTC)

It's very simple. If you estimate that it's going to cost $800 million to bring a drug to market, then you're not going to pursue doing so unless you will also be able to sell the drug at a high price. This is going to keep a substantial number of drugs from seeing the light of day, because not enough people are willing to pay such a high price for every drug. The cheaper it is to bring drugs to market, the more drugs will be brought to market because lower prices can be charged that more people are willing to pay. The more drugs that are in the marketplace, the more competition. The more competition in drugs, the lower the prices. Think twice before you argue against a Nobel prize winning economist on basic economics. Regulations 05:53, 26 March 2007 (UTC)
Here you go, from Power to the Patients, by Gary Becker: "It follows that a return to a safety standard alone would lower costs and raise the number of therapeutic compounds available. In particular, this would include more drugs from small bio-tech firms that do not have the deep pockets to invest in extended efficacy trials. And the resulting increase in competition would mean lower prices – without the bureaucratic burden of price controls. In turn, cheaper and more diverse drugs would induce insurance companies and public providers to cover many more new drugs, even when their efficacy was uncertain." Regulations 06:22, 26 March 2007 (UTC)
OK, so now we are talking about "me too" drugs, rather than the "First in class" drugs the $800 million figure supposedly refers to (you admit my logic is correct for a first-in-class drug, right?) Let's run with that: Your claim is that drug companies are going to forgo the sort of large randomized clinical trials required by the FDA in order to introduce unproven "competing" drugs which otherwise would not be cost-effective to develop, and that this would somehow lower the price of the "first in class" drug. I find that a pretty absurd claim - you might get a few kooky doctors who would be willing to prescribe an unproven "competitor" drug to their patients when proven drugs already exist for the same indication, but not many. It's not going to make any real dent in the market or price for that original proven drug. And I don't care how cheap a drug is - if I don't know that it WORKS, I'm not going to prescribe it to a patient. Insurance companies do not cover unproven treatments, period - nor should they. True "competition" only happens between drugs with a similar degree of efficacy and level of evidence supporting them, and it costs the same to do a clinical trial whether required by the FDA or not. -Rustavo 06:35, 26 March 2007 (UTC)
Just because efficacy trials are not required, it doesn't mean efficacy trials wouldn't take place. It just means they are voluntary. If consumers want efficacy trials, then there will be efficacy trials (just as you said, "if I don't know that it WORKS, I'm not going to prescribe it to a patient"). But the extensiveness of those trials won't be determined by a fascist central planning. I will be determined by supply and demand. For more expensive drugs, of course, consumers will demand more efficacy testing in order to coax them to spend their money. For cheaper drugs, less extensive efficacy trials would be taken in order to pursuade consumers to purchase a drug. (If a drug doesn't do what it's said to do, they are liable). The point is to decentralize the decision making process down to the individual level so that the drug market becomes more efficient, so that more new drugs are introduced, and more lives will be saved, and more suffering averted. Regulations 06:49, 26 March 2007 (UTC)
How could they be held "liable" if no one ever does the study to prove that the drug doesn't work, or is unsafe? To take a recent example, the drug torcetrapib, which was designed to raise "good cholesterol" (HDL) recently failed a phase III trial which showed that it increased, rather than decreased the risk of heart attacks. If it had been approved after phase II studies, some doctors might have prescribed it to their low-HDL patients, since theoretically it was expected to lower cardiovascular risk. As a result, many of those patients would have been killed. But without a large-scale randomized trial, that would be impossible to prove. The current system forces drug companies (the only private party with a large enough financial stake in a single drug) to pay for those trials. If they didn't, who would? I'm going to go out on a limb here and assume you don't support massive taxpayer funding of phase three trials. Even worse, without regulation, a drug company could do all the studies it wants and selectively release only the results that make the drug look good.
Also, the FDA is not "fascist central planning" - they do not tell the drug companies how to design studies in advance. They merely say that the companies will have to demonstrate safety and efficacy according to generally accapted international medical standards. After reviewing the NDA, they may decide that the drug company did not meet those standards, and suggest specific additional studies they could conduct to do so.
Finally, the idea that lawsuits are an efficent or desirable way to regulate the health care system does not pass the laugh test. The FDA employs experts who train their whole lives to understand medicine, biostatistics, pharmacology, and clinical trials. Most jurors barely know what a clinical trial is. I think that I would have questionable competence to analyse a web of unregulated clinical trials, postmarketing anecdotes, and contradictory "expert witnesses" to decide if a drug "does what it's said to do," and I went to medical school. This is why we have experts, and the FDA. --Rustavo 23:49, 26 March 2007 (UTC)
Of course more ineffective drugs would be prescribed. But you're ignoring the fact that more safe drugs would be prescribed too, along with that. Right now, there are drugs that never see the light of day because they're too expensive to bring to market. How do YOU know that the regulations have a NET benefit? How do you know that regulations prevent more ineffective drugs from coming to market than prevent effective drugs from coming to market? You don't. You have to admit that. Milton Friedman made the point that you simply cannot see the drugs that do NOT appear. That's why you take the position you do. You don't know what could have been, because you don't see all the drugs that could have come to market that have been prevented from coming to market. There is a trade-off. But how do we know what is the optimum standard set by the government to cause a NET benefit? We simply don't know. We can't know. It's impossible to know, because we can't see what it not being produced as a result of the forced requirments that we set. One thing we do know is that markets work. The system which allows decentralized individual decision making, instead of using force to prevent individuals from making their own decisions, otherwise known as central planning results in a mismatch between consumer preferences and what consumers get. I understand it is difficult for you to trust the market because you instinctively feel that there should be an authority figure ruling over it, but why should we trust a central planner (a "fascist") to make decisions for everyone in the country? How can that central planner possible know what risk/reward scenarios all individuals are willing to accept? They can't. And, of course lawsuits can help regulate. It's illegal to sell something with the claim to do something that it doesn't do. It is in a firm's self-interest to not make fraudulent claims, not only to avoid lawsuits, but to maximize long term self-interest in order to stay profitable and be trusted when they bring a new drug to market. Regulations 00:24, 27 March 2007 (UTC)
You'd be hard pressed to find a group that defends & values their independance from "authority figures" more than physisicans. You don't know my ideology because I am not inserting it in this article. I have added anti-regulation references (see my Louis Lasgna quote) and pro-regulation references to this section. I am simply trying to ensure that this article convey facutal, well-referenced information, and that non-mainstream criticisms are accurately but CONCISELY conveyed. Let me know when you are interested in addressing the issues I raised above.-Rustavo 01:26, 27 March 2007 (UTC)


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)

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)
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)