Talk:U.S. Food and Drug Administration/Archive 1

Archive 1

Criticism: Delays in drug approval section

Somebody is putting this POV back in: "In more recent times, the FDA's attention to more timely approval has been evident. For example, the recently approved HIV drug Fuzeon had a rapid turn-around time between the onset of clinical testing and final approval. The New Drug Application ("NDA"), the manufacturer's license to ship the drug across state lines for clincal testing (see above), was approved on September 16, 2002. The drug was made available for compassionate use in October of 2002, and final approval was granted on March 13, 2003" They're neglecting to mention that the IND was filed in 1996. 1996-2003 is still a 7 year approval. How is that "more timely approval" when IND to approval in 1998 was 7 years as well? Maybe they mean more timely approval relative to the high of 10 years in 1970's? Regulations 15:21, 22 March 2007 (UTC)

As I said before, I agree that Fuzeon is a poor example of rapid drug approval. I have added referenced information about accelerated approval of early HIV drugs & the comparison of their approval in the US vs. other countries. I left a shortened version of the Fuzeon blurb in because I think it illustrates why some drugs take longer to approve than others. -- Rustavo 18:32, 22 March 2007 (UTC)

Regulations, you should actually read the FDA article you are so adamant about editing. If you read it, you would understand that there is a difference between an IND and an NDA. The IND is the manufacturer's initial submission to the FDA that they are interested in starting clinical trials for the drug. Then the manufacturer does the clinical trials. The FDA and manufacturer have discussions during this time, sure, since the manufacturer wants to conduct a clinical trial that has a good chance of getting the drug approved, so the FDA advises the manufacturer on what the FDA considers to be an acceptable clinical trial. The key point here, Regulations, is that from the IND submission to the NDA submission, the onus is completely on the manufacturer to collect clinical data on the drug. The FDA isn't really involved at this point. The speed of the progress after the IND has more to do with manufacturer funding of clinical trials and how rapidly they can accrue patients. It also has to do with the quality of the data. If the clinical trials are poorly designed, the FDA can tell the manufacturer to go back and get more data, or get better data. Martha Stewart allegedly found out about this very kind of advice in advance of its official announcement, and her ImClone stock was sold early, leading to an accusation of insider trading. So you see, the length of the "approval process" is indirectly dependent on the FDA, but also on a lot of other factors. I think a more accurate indicator of the speed of the FDA is to look at the time between the NDA and the final licensing for marketing, since this is a marker of how long the application data was stalled by the FDA bureaucracy. In many cases, the FDA comes out looking good. For a more recent example than Fuzeon, on the new cancer drug, Tykerb, the NDA was submitted on September 18, 2006, and marketing approval was granted on March 13, 2007, about six months. I think that's a reasonable amount of time for due diligence in a deadly disease, though some disagree.--Dr.michael.benjamin 05:59, 23 March 2007 (UTC)

I know that there is a difference betwen IND and NDA. Don't you see that the reason that the time between the IND and the NDA has increased is because the standards for approval have become more strict? Don't you realize that the increased regulations by the Kefauver Harris Amendment causes the need for extra time and extra precautions before submitting the NDA? The time to look at is most definitely from IND to final approval. It didn't take 6 years from IND to NDA before Kefauver. Regulations 15:33, 23 March 2007 (UTC)

So if your problem is that drug company clinical trials take a long time, all I can tell you is, beats the alternative. If you can think of a way to assess the safety and efficacy of a drug and not have it take six years, by all means, please let the world know. Really. We need new ideas on how to determine whether a drug is safe and effective in the fastest possible time. My cancer patients would be very happy to not have it take six years for a drug company to finish its clinical trials. They are also happy that I can recommend drugs that have a reasonable chance of success, and won't kill them, based on the FDA approval process. You seem to have a problem with the concept that clinical trials have a value to society. That idea of yours is just wrong, for many reasons. Your good health and that of your family is very likely the consequence of the tough regulations enacted by the Kefauver Amendments--I, for one, would not want to go back to the dangerous times before that regulation came around. In any case, the place to argue that the clinical trial is not a good way to determine the value of a drug is probably a blog somewhere, but not the Wikipedia entry on the FDA. You are entitled to your opinion, just not to express it in this particular venue. See below.--Dr.michael.benjamin 07:16, 24 March 2007 (UTC)

First of all, stop being hypocritical. Don't tell me not to express my opinion here, when you're expressing your opinion as well. I do not oppose clinical trials, even 200 year clinical trials if necessary. I advocate and fully support clinical trials. What I oppose is the government forcibly setting the standards. The amount of testing a person required before he takes a medicine should be a decision between doctor and patient. You call yourself a doctor, but you don't even respect the natural rights of the patient to live his life as he sees fit. If an individual wants to wait for 20 years before he takes a drug, that should be his right. If he wants to take a drug without any testing at all, that should be his right as well. Regulations 17:21, 24 March 2007 (UTC)

Who should set standards for drug approval then, Reg? You? You sound like an intelligent person, but you have no idea how many medically ignorant people there are out there. You may not like government regulation of the speed limit either, but it keeps the freeway fatalities at a manageable number. Anarchy doesn't work with speed limits, and it isn't a meaningful standard for drug regulation either. We had drug deregulation in the 1930s, and what we got was a lot of snakeoil and elixirs. What we have now are lifesaving drugs. Again, your opinion about drug deregulation is a valid one, just not reflective of the state of the FDA now, so it doesn't belong in the article.--Dr.michael.benjamin 05:09, 25 March 2007 (UTC)

I think the main purpose of Wikipedia is to erase ignorance, not to provide a platform for people to air a particular point of view.--Dr.michael.benjamin 05:59, 23 March 2007 (UTC)

A criticism section is definitely the place to air a particular point of view, that point of view being the point of view of the sources. Regulations 15:34, 23 March 2007 (UTC)

The criticism section is a place to concisely summarize noteworthy criticism of a subject. Right now it's bloated and mostly a soapbox to expound on a bunch of anti-FDA rhetoric. For instance, the whole "Criticism of over-regulation" section could be summed up as, "Some economists, such as Gary Becker and Milton Friedman, as well as libertarian organizations have criticized FDA regulation, claiming that it increases the cost of drugs and delays availability of potentially life-saving treatments." Add a few footnotes, and it's done. We really need to figure out how to make the criticism section more encyclopedic, concise, and readable. MastCell ^Talk 22:13, 23 March 2007 (UTC)

I disagree. It needs to be enyclopedic, lengthy and detailed. If it gets too large, just give it its own article. No worries. Regulations 00:38, 25 March 2007 (UTC)

Additionally, there has to be a way to cut back on the length of some of those sections. WP:CONCISE ftw. The article is ugly when you're trying to use the TOC. Given the ... heat ... surrounding the Criticism sections, I felt being bold was not in the best interests of the article. But someone who is involved in the discussion might want to consider tossing around idea for cutting back on the length of those subsec headings. // 3R1C 15:17, 31 March 2007 (UTC)

Please, feel free to be bold. -Rustavo 15:54, 31 March 2007 (UTC)

Done. // 3R1C 21:43, 31 March 2007 (UTC)

How long should the criticism section be?

Obviously we have an ongoing disagreement about the proper length and content of the criticism section. I'd like to avoid this becoming an all-out revert war. Here's my opinion: The primary purpose of this article is to give factual information about the FDA i.e. its history, its regulatory authority, the mechanisms by which it exerts that authority etc. A SECONDARY objective is to make people aware of the existance of specific, well-substantiated criticisms of the FDA, and to direct them to reputable sources by which they can further explore those issues if they care to do so. Because doing this presents serious potential for POV abuse and detraction from the primary purpose of the article, the criticisms and their rejoinders should be presented as concisely as possible. If it is felt that certain very important criticisms, which are well-substantiated by current evidence, cannot be conveyed concisely on this page, perhaps a separate page should be created to discuss those criticisms in a more in-depth manner.

To summarize: criticisms should be WELL-SUBSTANTIATED by CURRENT REFERENCES and should above all be CONCISE and BALANCED by equally well-substantiated and current REJOINDERS. --Rustavo 03:47, 24 March 2007 (UTC)

I think some of the shorter sections I put together read a little better (as of this minute...see how long it lasts...) I like the AZT example, BTW.--Dr.michael.benjamin 07:17, 24 March 2007 (UTC)

Also, Rustavo, I like the idea of a specific FDA criticism page--let the "crackpots" have a special arena to air their gripes.

Should be whatever length it takes to represent all the criticisms out there, such as the the view of 73% of neurologists and neurosurgeons that unapproved drugs should be made available with a warning label that they are unapproved. These are included in the "crackpots" that "Dr.michael.benjamin" speaks of. Regulations 19:58, 24 March 2007 (UTC)

You do realize that the survey you mentioned was conducted by the Competitive Enterprise Institute, an explicitly partisan anti-regulation think tank with a clear axe to grind, and is in no way impartial, objective, or representative of the opinions of the majority of physicians, right? MastCell ^Talk 00:29, 25 March 2007 (UTC)

You do realize that the Competitive Enterprise Institute didn't conduct the survey, right? The Polling Company [1] did. The survey was a scientific survey that does indeed reflect the opnions on the majority of neurosurgeons and neurologists. Regulations 00:36, 25 March 2007 (UTC)

Sorry, but the objectivity of that survey is, at the very best, extremely suspect. A brief glance at "the polling company's" other clients indicates their political leanings. And the bottom line is that it was performed under the aegis of the CEI. MastCell ^Talk 00:40, 25 March 2007 (UTC)

Oh well. Everybody is going to have a criticism for a survey they don't like. The Polling Company's reputations rests on the accurateness of their surveys, so I don't see any reason to think they did anything fraudulent. I thought it was pretty well known that doctors typically don't like the FDA, anyway. Regulations 00:49, 25 March 2007 (UTC)

I'm a doctor, and I really like the FDA. I think the Kefauver Amendment has saved thousands of lives by keeping dangerous drugs off the market. I can't speak for "most doctors," just myself :)--Dr.michael.benjamin 05:04, 25 March 2007 (UTC)

There are some questions on these surveys which flatly violate the principles of valid polling. For example, question 4 reads "In your opinion, to what extent does the public understand the human cost of the FDA approval process, that is, that some people may suffer or die waiting for the FDA to act?" That is a classic fallacious question in that it states a highly controversial premise as fact - it might as well read "To what extent does the public understand the way in which the FDA commissioner beats his wife?" The surveys use standard devices of political push-polling. It is revealing that the CEI never published these findings in a peer-reviewed journal, especially considering that surveys of doctors are frequently published in medical journals, and these surveys themselves reveal the premium placed by doctors on published research. I think the reason they were not published is obvious - the methodology is so biased and the questions so leading that the responses really can't be interperated. They were intended as a PR tool, not a scientific survey.

-Rustavo 05:10, 25 March 2007 (UTC)

Whether the poll "violates the principles of valid polling" is your opinion. One can pick apart any poll. But your opinion on that really doesn't matter as far s this article is concerned. You would have to find a source disputing the poll and note that in the article. And yes the poll was not publised ina "peer-reviewed journal." Poll aren't usually published in peer-reviewed journals. There is no requirement that they be published in one in order to appear in a Wikipedia article. Regulations 17:22, 25 March 2007 (UTC)

By the way, in regard to the question in the poll you're referring to, it's a given that some people may suffer or die waiting for the FDA act. There is nothing controversial about that. That's a self-evident truth. If there is medicine that someone needs to feel better or survive longer, and it's not approved, then that person may suffer or die. Regulations 17:26, 25 March 2007 (UTC)

Yes, and it is uncontroversial that thousands of people "suffer and die" from drug side effects every year (even from good drugs that deserve to be on the market). By your logic, it would thus be perfectly fair to ask "To what extent is the public aware of the fact that people suffer and die from the FDA approving drugs too quickly." The real question is whether the FDA process overall is either too lax (so a net excess of people die from side effects) or too strict (so a net excess of people die witing for drugs) or in fact is about as good as a system run by humans could be. This is extremely controversial and you can find may medical professionals and other experts who will take any of those three positions. Also, opinion polling is not 'Nam - there are rules, and some particularly bad polls, like the CEI one you quoted - can be picked apart more easily than others.-Rustavo 03:49, 26 March 2007 (UTC)

Your personal criticism of the poll do not justify its removal from this article. But, if you want, leave out that question. I don't care. That one's not that important. More important are the questions like "The FDA is too slow in approving new drugs and medical devices." 67% and "What would your position be on a proposal to change FDA law so that unapproved drugs or devices could be made available to physicians as long as they carried a warning about their unapproved status?" 73%. Do you see a problem with those questions? Regulations 06:16, 26 March 2007 (UTC)

Look, if you want to keep the poll, that's fine, but it needs to be made explicit that the poll was commissioned by the CEI. The CEI is (in)famous for (mis)using the trappings of science in the service of its paymasters. They used to be a tobacco-industry attack dog, going after the FDA and EPA on second-hand smoke (see here, under "Non-tobacco attacks on FDA", or just search the declassified tobacco documents for "Competitive Enterprise Institute"). Then they moved on to misquoting the scientific literature on global warming (see here) for ExxonMobil. So you'll excuse my skepticism about the objectivity of this poll. The major question, in my mind, is how the sample group was selected. This is probaby the major question for any opinion poll, but it's glossed over here - the poll says the respondents were "selected and screened" from a random sample. Selected and screened how? On what basis? This is a HUGE red flag. MastCell ^Talk 15:30, 26 March 2007 (UTC)

Wow, I didn't notice that - good point! The survey is even more ridiculous than I thought. -Rustavo 05:23, 27 March 2007 (UTC)

References in criticism section

Because of the obvious threat of POV in the criticisms section, the references there need to be solid and reputable. Whenever possible, references should be to PEER-REVIEWED, PUBLISHED WORK when referencing an original argument in the area of economics or medicine. At the very least, such references should be made to a PRIMARY WORK which describes its METHODOLOGY. I have removed one reference to the "dug cost" section which pointed to a "popular press" type account put out by a libertarian organization which cited an oral presentation in which a "research scientist" argued that "80% of modern drug prices" are due to certain FDA regulations. I find this to be an extraordinary claim requiring extraordinary evidence & detailed methodology on how that number was calculated. Instead, we have a secondhand account of an oral presentation by a person with no economics training who (as far as I can tell and I did an extensive search) never published her medical "economics" work in a peer-reviewed setting. She appears to have done some lab-based research on liver disease up until the early 1990's, and became a politially active Libertarian when her pet theory that adding hormones to alcoholic beverages would prevent liver disease was deemed to be unfeasible. Dude, your references need to be better than this.

Also, if one is going to quote "nobel prize winning economists" a formal economics paper (I assume they published a few) would be a better reference than a magazine editorial with no methodology or references. -Rustavo 05:48, 24 March 2007 (UTC)

If you're talking about Becker, that's not something that can be measured by an economics study. What he's saying is that prior to 1962, only safety was required to be proved to the FDA. After the 1962 regulations, they started requiring proof of efficicacy as well. His recommends that those regulations be eliminated in order to lower prices. His opinion is that it's not worth the extra cost just to make sure the drugs do what they say the do. If drugs are falsely advertised, drug companies can already be sued. There is no one that would dispute that eliminating those regulations would lower drug prices. That's obvious. Regulations 18:27, 24 March 2007 (UTC)

Reg, there is a reason this doesn't make sense to those of us who are actually in medicine. All drugs have side effects. Some are worse than others and many widely used drugs have very common mild side effects or rare severe or even fatal side effects. The FDA approves drugs based on whether the benefit to a patient for at least one indication outweighs the potential harm caused by the drug. You can't consider safety and efficacy in isolation - if we only considered safety, no chemotherapy drug would ever be approved because they are incredibly unsafe. They are approved because their efficacy at fighting a deadly disease outweighs the huge risks they pose to patients. Only a person who knows NOTHING about medicine could claim that the FDA should simply set a "minimum safety standard for all drugs". Saying we could use pre-1962 regulations for the modern drug era is like saying we should eliminate air traffic controllers because back in the 1800's they didn't exist and hot air balloons hardly ever ran into one another. Most of your arguments are either wildly out of date or use highly dubious sources.

Also I will continue to delete comments like "so-and-so thinks the FDA should be eliminated." It is pure POV and irrelevant. An acceptable comment might be "so-and-so demonstrated through the following referenced analysis (from sometime this century) that elimination of the FDA's drug approval powers would be likely to lower drug prices by 80%." The reader could then READ that analysis for themselves and decide whether that figure is supported or just pulled out of someone's hiney.

--Rustavo 04:20, 25 March 2007 (UTC)

I'm deleting "Public Citizen suggests that the actual cost is under $200 million, about 29% of which is spent on FDA-required clinical trials.[21]" Who is Public Citizen? There is no name of the person making these claims on that webs site. That can't be a credible source by any standard. Regulations 18:12, 24 March 2007 (UTC)

Come on now. Public Citizen is a well-known consumer advocacy group founded by Ralph Nader. If you're not sure who they are, before deleting the sourced information Google them or read the Wikipedia article. What they have to say is at least as notable, if not far more so, than 99% of the critics quoted. I'm going to assume that you deleted that information in good faith, not realizing this; Public Citizen is a reliable source for this sort of thing, so I'll restore it now. MastCell ^Talk 00:27, 25 March 2007 (UTC)

I think Reg is responding to my insistance that we reference only sources which fully describe their methodology. The previous ref was to a page on the Public Citizen website which responded to Dimasi's 2003 research. It does explain its methodology, but not in a detailed or formal manner. The reason is that PC had issued a full-length report on this issue (yes, with authors listed, Reg) in 2001, and they merely reapplied that same methodology to criticise Dimasi's new paper. I've added a ref linking to the full 2001 report.

-Rustavo 07:08, 25 March 2007 (UTC)

I agree, MastCell. I redacted the crit section again. I agree that the stuff from the think tanks and magazines are garbage. That stuff is just not criticism that matters. The OTC regulation is a non-issue. If people have specific problems with the FDA, they need to write their congressman.--Dr.michael.benjamin 05:16, 25 March 2007 (UTC)

Maybe the cost of drug development deserves its own article--why would someone look in the FDA article to read a discussion of the different estimates of drug costs. As we are finding with our research, there are at least three numbers--that probably can be the basis of a new article...--Dr.michael.benjamin 05:16, 25 March 2007 (UTC)

Safety and Efficacy

First, I did not "delete Becker's main argument" because you had already made it in the previous paragraph - you simply repeated it at the end of the entry so that you would have the last word.

As I have written before, and you have not responded to, the idea of eliminating the "efficacy" testing without eliminating the "safety" testing revels ignorance of the purpose of the three phases of clinical testing. ALL THREE phases (and often post-market survalliance) are required to ensure drug safety. The small phase one trials do not establish that a drug is "safe" because they only have the power to detect very common and/or unusual side effects. All they establish is that the drug is safe enough to proceed to the next phase of testing - ditto for safety testing in phase II. I've rephrased your entry a bit to address this reality.

Second, there is no such thing as evaluating "safety" in isolation in the current system. Drugs are evaluated based on their safety relative to the benefit they bring to patients (i.e. their efficacy). We tolerate much worse side effects in chemotherapy drugs (which may be effective in saving someone's life) than we do in anti-impotence drugs, for example. Unless you can provide a reference which explains what Becker is actually suggesting in a way that makes sense to the medical professional contributors to this page, we will likely continue to trim your material. --Rustavo 23:22, 26 March 2007 (UTC)

We will likely trim your material in return, until you get a grasp on what Becker is saying. Regulations 00:28, 27 March 2007 (UTC)

What part of the above comments demonstrate a "failure to grasp?" I am still waiting for an explanation and a reference containing some semblance of methodology.-Rustavo 01:07, 27 March 2007 (UTC)

What don't you understand? He simply recommends eliminating the regulations that require proof of efficacy to the FDA. This makes drugs cheaper to bring to market, resulting in more drugs being brought to market. The more drugs, the more competition. The more competition, the lower the prices. Prior to 1962, efficacy needed not be proved. He advocates rolling back all the regulations introduced by the Kefauver-Harris Amendment. Regulations 01:13, 27 March 2007 (UTC)

How many times do I have to repeat this? A "safe" drug as evaluated by the FDA is one for which the "risks do not outweigh the benefits." Efficacy testing is inseparable from safety testing. There are not separate "efficacy trials" that could be eliminated - pivotal phase III trials are the most important part of safety testing. So either you are suggesting much lower (and arbitrary) safety standards, or the "repeal of the Kefauver-Harris Amendment" would have no effect. Choose one, and PROVIDE A BETTER REFERENCE. -Rustavo 01:43, 27 March 2007 (UTC)

Prior to 1962, there was no proof of efficacy requirement. Becker advocates eliminating all of the regulations introduced by Kefauver-Harris, along with any safety regulations that were included in that. What's so hard to understand? Do you deny that there was no requirement for proof of efficacy prior to 1962. What are you trying to say? Regulations 01:48, 27 March 2007 (UTC)

Your (and Becker's) obsession with 1962 is the problem. "Safety" and "efficacy" are not defined by the medical community (the standard used by the act) in the same way they were in 1962. To modern medical professionals, the concept of a "safe drug" has no meaning in isolation from efficacy. The concept of safety is inseparably tied to efficacy, because "safety" is a balance of the risks and benefits of a drug. See [2]. I am sorry if I have not made this clear in my previous five posts on this topic(although you might want to read back if you just skipped them). -Rustavo 02:20, 27 March 2007 (UTC)

Regardless of how you define safety, prior to 1962 efficacy was not taken into account in the equation. Regulations 02:33, 27 March 2007 (UTC)

Thank you for the irrelevant historical fact. You know, the History section in this article could use some work. -Rustavo 02:37, 27 March 2007 (UTC)

It's very relevant. It's the point. By requiring that efficacy be taken into account when determining whether the FDA thinks something is safe, it increased the costs of bringing drugs to market. Regulations 02:39, 27 March 2007 (UTC)

If the word "efficacy" was struck from every FDA authorizing statute tomorrow, they would still require proof of efficacy in order to evaluate safety, because that is part of the accepted definiation of safety by modern medical experts. -Rustavo 02:48, 27 March 2007 (UTC)

Not prior to 1962. Regulations 18:54, 27 March 2007 (UTC)

For what it's worth, safety and efficacy are completely different things. Safety and efficacy have strictly defined meanings, and one great thing the Kefauver-Harris Amendment did was to legislate the definition of efficacy, with input from the nascent science of pharmacology. --Dr.michael.benjamin 01:21, 29 March 2007 (UTC)

DiMasi

What kind of idiocy is this, from DiMasi? "At the time that drug prices are determined, the associated R&D spending for a drug is a sunk cost. Basic economic logic tells us that R&D costs do not determine prices." Doesn't he realize that that the cost won't be "sunk" in the first place unless it is projected that the investment can be recouped ...unless it is projected that there a market for a high priced drug? If it's cheaper to bring that same drug to market then a lower price can be charged, and, quite possibly, therefore higher profits. It's as if he thinks higher prices = higher profits. That is not the case unless demand is inelastic, which it is not. It is often more profitable to charge a lower prices than a higher price. And, of course, he ignores competitive pressures. If you can bring a drug to market for a lower cost, then you are able to better compete against other drugs, which can institute a price war. It's hard to belief that DiMasi is an economist. Regulations 02:26, 27 March 2007 (UTC)

"If it's cheaper to bring that same drug to market then a lower price can be charged, and, quite possibly, therefore higher profits." No, this is flat wrong. The price which maximises profits (sales X price - production costs) is independant of the cost of development. You point about competition would make sense if pharmaceuticals operated anything like a perfect market, but it doesn't - the reasons for this are complex & controversial - you can exchange angry letters with DiMasi if you want details. By the way, I'm still waiting for a real published reference from any of the economists you are fond of quoting. -Rustavo 02:44, 27 March 2007 (UTC)

Yes the price which maximizes profit is independent of the cost of development, but the cost of development won't be taken unless it is projected that the cost can be recouped ..unless it is projected that there is a market for a high priced drug. If there is not such a projection, then the costs won't be expended. Let's say for example, that the profit maximizing price is $1/pill. If they cannot charge that low of price but charge a higher price and still be profitable, then they will expend the investment and charge higher than $1/pill. If the same drug can be produced for a lower cost, because of the elimination of coercive regulation, such that they can actually charge $1/pill and be profitable then that's what they'll do because that is the profit maximizing price. There is a direct relation between prices charged and costs of investment. Regulations 02:54, 27 March 2007 (UTC)

This doesn't make any sense. How could the drug be unprofitable at the profit maximizing price, but be profitable at a higher price? The definition of a "profit maximizing price" is that any price - higher or lower - is less profitable. Seems pretty clear to me. Either they can make an net positive profit at the profit maximizing price or they can't - as you say, if they know in advance that the latter will be the case, then they will not develop the drug, but the price of the drug if they do develop it will be no different (the "profit maximimizing price" could still result in a negative profit - it would just be the smallest possible loss.)-Rustavo 03:13, 27 March 2007 (UTC)

You can make a profit selling at a higher price, even though selling at a lower price will reap more profit. Understand? Beginning at some point, the higher price you charge the more customers you start losing. There is some price X which maximizes profit, above which starts eroding profit and below which starts eroding profit. Let's say X +10 is the price where you will have zero customers. You will make any investment that will allow you to sell your drugs at any price from X all the way up to X+9. If the costs to you are so great that you can only charge greater than X, but less than X+10, then you will invest and sell at a price greater than X. If the costs to you are low enough that you can charge X, then you will invest and charge X. Regulations 03:24, 27 March 2007 (UTC)

You are digging yourself deeper into a hole of noncomprehension. Let's spell out a simplified example. A drug company calculates that the profit maximizing price of the drug is $20 per dose, and at that price, they will sell 10 million doses over the lifetime of the drug for net proceeds of $200 million - since it costs $5 per dose to make the drug, their profit (not counting development costs) at the profit maximizing price is $150 million. If they raise the price to 21 dollars, they will only sell 9 million doses (people are priced out) so their profit would be only $144. If they lower the price to $19 dollars, they will only sell a few more doses, and will also end up with a lower profit. That's why $20 is the "profit maximizing price." And that is what they will charge, however much we as consumers might want them to set a lower price. So far so good?

First let's say the development costs for the drug are $100 million. They'll change the PMP and make an overall net profit of $50 million. Now let's say an evil regulatory agency makes them do more tests and development costs $200 million. In this case, at the PMP, they will lose $50 million. If they know this and have not yet "sunk" the development costs, they will simply not make the drug. If they HAVE already "sunk" $100 million in development costs, they WILL develop the drug because their future development costs ($100 million) are less than their future profits ($150 million) - so they will be out a total of $50 million instead of $100 million if they chose to abandon the drug. If they have already sunk $200 million, again they will still sell the drug at the profit maximizing price for a net loss overall of the same $50 million. In NO CASE would it help them to change the price of the drug because our earlier calculation is unaffected by the development costs - raising the price to $21 would give them an even greater loss ($56 million) than at the PMP.

Repeat after me: "Development costs do not affect the profit maximizing price, and companies will ALWAYS charge the profit maximizing price if they decide to make the product at all." -Rustavo 03:59, 27 March 2007 (UTC)

On reading your re-write of your latest post, you seem to be under the mistaken impression that companies charge the lowest price that makes them profitable. This is not what companies do. They charge the price which yields MAXIMUM profits. No company ever charged a lower price just because they "could". -Rustavo 04:07, 27 March 2007 (UTC)

And, the price that yields maximum profit is lower than other prices it can charge and still profit but profit less. That's what you're missing. The lower the investment, the more profitable they can be, because they can charge that lower price. The investment is not "sunk" until it is made. A company has to make a profit. It won't make that investment unless it can profit. And, it will make that investment even if it can't reap maximum profit (which would come from charging a lower price than a higher price). Regulations 17:47, 27 March 2007 (UTC)

While these are interesting issues, Wikipedia talk pages are not a forum for general discussion. Let's bring it back to concrete examples of what we'd like the article to say. MastCell ^Talk 17:11, 27 March 2007 (UTC)

Example of an authoritative reference

Here Ref, why don't you try replacing some of your shaky references with info from this GAO report: [3]. Note how it is a formal report and not a popular press opinion column. Also note how it explains its methodology and cites its sources. Go to town. -Rustavo 07:49, 27 March 2007 (UTC)

And we could always consider citing the peer-reviewed medical literature (e.g. PMID 11268222), which suggests most people would prefer increasing FDA regulation of things like dietary supplements, rather than decreasing regulation of prescription drugs. Or an AARP survey also finding broad support for increasing the FDA's regulatory mandate (note the methodology of the poll sampling is spelled out). Or a nationwide Harris poll (no disrespect to The Polling Company) finding that most people took for granted that the FDA was looking out for them, even when it's not (see "Drugs vs. Supplements"). In the interest of balance and avoiding undue weight and all. MastCell ^Talk 16:46, 27 March 2007 (UTC)

Let's move criticism section to separate article

It is getting way too big on this article and dwarfs just the basic information that this article should provide about the agency. Any thoughts? Remember 19:13, 27 March 2007 (UTC)

Sure. Let's just make one small section about criticisms and then point out that the main article is "Criticisms of the FDA". I'm getting tired of people deleting information under the pretense that we're running out space. Regulations 19:14, 27 March 2007 (UTC)

The problem is not "space". The problem is the undue weight (see WP:NPOV) which is being given to criticism (particularly certain criticisms) of the FDA. Realistically, the FDA is not criticized heavily enough to warrant its own content fork (unless one includes every Ph.D thesis and libertarian newsletter out there), and such a move would greenlight and exacerbate the problems we're having with undue weight. Criticisms could easily be summarized without dwarfing the article if we applied WP:NPOV and WP:WEIGHT. See my suggested summary of the "Criticism of overregulation" section above. MastCell ^Talk 19:32, 27 March 2007 (UTC)

Looks like we will just have to agree to disagree here. I think there is a vast amount of fair criticism of FDA from both those that want more regulations and those that want less. I'm not saying I agree with it all, but I can understand their criticisms of the agency. How does everyone else feel about creating a fork? Remember 19:52, 27 March 2007 (UTC)

I've disagreed with that suggestion in the past. I agree with you that there are very important controversies about the FDA, and I think they are too important to be sidetracked on a separate page, which I suspect will be plagued by poor quality references and undue weight. I think nearly all of the sections in the current criticism section represent real and important issues which should be addressed, but I think that some of them are focused on very extreme or poorly referenced viewpoints, rather than on the mainstream debate which is ongoing among policymakers and in the academic literature. I'm going to hold off on editing the main page criticism section for a while, and I suggest we make one more concerted effort on the talk page to decide what does and does not belong in the criticism section - perhaps each contributor could write a summary of the topic headings and refereces which they believe should be used. Hopefully we can find a way to construct it so that the major controversies affecting the future of the FDA are all represented. I also think this page would be greatly enhanced by a proper history section. -Rustavo 21:14, 27 March 2007 (UTC)

"Realistically, the FDA is not criticized heavily enough to warrant its own.." You can't be serious. The FDA is constantly under attack from all directions. Regulations 02:05, 28 March 2007 (UTC)

Could you at least hold off on adding MORE silliness until we've had a chance to agree on a plan on the talk page? I mean, "The Freeman"? Seriously? I guess next we'll need quotes from the Comintern to 'balance' it.-Rustavo 02:20, 28 March 2007 (UTC)

I recall you insisting on keeping input from "The Public Citizen" website by an unamed writer even. The Freeman is a peer reviewed publication, and the author, Daniel B. Klein, is a professor of economics. Regulations 02:25, 28 March 2007 (UTC)

You recall wrong. I didn't add the Public citizen webpage you're referring to, and I agreed with you that it was not an adequate reference on its own. That's why I found the full Public Citizen report to which it referred, with methodology, references and authors, and I linked to it. If I had not found that report, I would have removed the public citizen piece entirely. The Freeman is an idological publication, not a peer-reviewed academic journal. -Rustavo 19:56, 28 March 2007 (UTC)

From the publishers of The Freeman: "Our flagship publication, The Freeman: Ideas on Liberty, is one of the oldest and most respected journals of liberty in America. For almost 50 years it has uncompromisingly defended the ideals of the free society. Through its articles, commentaries and book reviews, several generations of Americans have also learned the consequences and contradictions that inevitably result from collectivism, interventionism, and the welfare state."[4] Sounds like an idological/advocacy publication to me. -Rustavo 20:37, 28 March 2007 (UTC)

False equivalence. "Many believe..." are weasel words that, rather than being removed, are multiplying. As far as the volume of criticism, the Department of Homeland Security receives far more mainstream, notable criticism than the FDA, yet somehow the article manages to do without a separate "criticism of DHS" sub-article (Katrina aside). Basically, the good sources need to be separated from the non-noteworthy, and then the length issues will fall into place. Milton Friedman and Gary Becker are notable. The Ayn Rand Weekly Newsletter isn't. MastCell ^Talk 03:34, 28 March 2007 (UTC)

Laissez-faire economics is mainstream in academia. The de-regulation mindset is the status quo. Regulations 03:36, 28 March 2007 (UTC)

This is interesting. Economist Daniel B. Klein [5] says: "Although one can occasionally find remarks by economists vaguely favoring government restrictions on health products, those are not the economists who have written on the FDA or provided serious argumentation.3 I have tried to survey all economists’ writings on the FDA and have not been able to find a single instance of an economist defending the contemporary FDA or advocating tighter restrictions. Contrary to the joke about laying all the economists end to end, those who study the issue do reach a conclusion: Relax restrictions on drugs and devices." [6] Regulations 03:47, 28 March 2007 (UTC)

I'm sorry, but the idea that the FDA should be abolished, or its powers dramatically curtailed, is not mainstream anywhere. If it were, you'd be able to provide better references. But instead, we get the Independent Institute (source of the above quote claiming all economists agree) and the Competitive Enterprise Institute. Again, the lack of good quality sources is a clear indication that these views are not mainstream. MastCell ^Talk 03:53, 28 March 2007 (UTC)

What do you mean they're not good quality sources? Just because someone has a POV it doesn't mean they're not a quality source. You have to have a POV in order to be critical of the FDA. Regulations 04:10, 28 March 2007 (UTC) If you'll notice, also, I've been supplying studies as well. Believe me, there is a lot more to come. Regulations 04:11, 28 March 2007 (UTC)

Let's try to keep this particular area focused on one question: Do we want to create a fork for the criticism section or not. For all other disagreements please create a new section. I would argue we should have a fork for the following reasons: (1) the criticism section tends to be one of the longest parts of the article and dwarfs the other relevant information about the agency which would typically be found for an encyclopedic description of the agency and (2) it is the part of the article that is by far the most contentious and the most like to be tagged with clean-up notices, NPOV notices, and other such notices that make readers discount the value of the whole article. If we could break this part off from the main article, we would be able to focus this page on being as high quality as possible for a general description of the FDA while still being able to fully debate the other issues that constantly assail the FDA on a separate page. Other thoughts? Remember 12:24, 28 March 2007 (UTC)

Yes let's create a new article. There is way too much information out there that has to do with FDA criticism to fit in a small space. Regulations 16:29, 28 March 2007 (UTC)

Voting area

This vote is not intended to be definative, but just illuminate what everyone's opinions are in a concise fashion. Remember 17:24, 28 March 2007 (UTC)

• Support- I support creating a fork from the main FDA page to create a separate page exclusively to discuss FDA criticism. Remember 20:39, 28 March 2007 (UTC)
• Oppose as above. Criticism can fit here if we apply WP:WEIGHT. MastCell ^Talk 17:56, 28 March 2007 (UTC)
• Support But I don't think we need majority rule to create the new article. We can just do it. It doesn't harm this article in any way. And I think that those oppose it are simply pro-government people who just don't want all the criticism out there to be revealed. So they make the excuse that there's not enough space and delete information. Regulations 18:10, 28 March 2007 (UTC)

Uh, it would be best if you at least made an effort to reach WP:CONSENSUS before creating the content fork. Assuming the worst of other editors and speculating negatively about their motivation doesn't advance that goal. MastCell ^Talk 20:21, 28 March 2007 (UTC)

• Support - OK, I give up in the interest of reaching some stability. However, I think we should retain a section in the main page, titled "FDA reform", to discuss recent and ongoing events in FDA policymaking, such as court cases (e.g. the Abigail Burroughs case), active & pending legislation, ongoing and recent FDA policy reviews, congressional or presidential commissions & reports, official changes in FDA policy, etc. This would include some of the items currently in the criticism section, but they would be presented as "current events" rather than ideological arguments. This should follow a full and strictly objective "FDA history" section. Also, some items in the criticism section, such as scholarly estimates of the current cost of drug development could be placed (without editorial comment) in appropriate sections of the main article.-Rustavo 20:28, 28 March 2007 (UTC)

I like this suggestion. Remember 20:40, 28 March 2007 (UTC)

Version 1.0 is up and running - See History/Drugs past 1938/changes and reforms 1992-present. Let the edits begin! -Rustavo 21:06, 7 April 2007 (UTC)

• Comment - I just ran into Criticism of the FDA by accident (its single-editor history turned up it inappropriately on the WP:COI bot results). It does look to me like a POV fork based on far too small a consensus, and I agree with MastCell that "I think that those oppose it are simply pro-government people who just don't want all the criticism out there to be revealed" is a distinctly non-neutral argument for forking it. How about a topic RFC to get a wider range of opinions? Tearlach 20:20, 4 April 2007 (UTC)

I suggested it here (and I tihnk someone else brought it up on a private talk page) but none of us are really familiar with the process. It could certainly use some looking into from someone involved in Wikipedia who is familiar with neutrality issues. I was also thinking about bringing it up with the Neutrality Project, but again I don't think any of us are familiar with that process. // 3R1C

After reflection, I posted a topic RFC [7]. There's not much process to that; you just ask for input, and anyone interested in the subject can comment. Sometimes it helps. Tearlach 00:30, 5 April 2007 (UTC)

• Oppose vote from RFC-responder. I saw this interesting RFC posted, so here is my comment People are going to complain that the sub-article doesn't properly relate to the main article. See Wikipedia:Summary_style. At a minimum, you should include in the main FDA article a summary of what's in the criticism article. But there is a new problem, that there's no obvious place where you would attach this summary. The main article has no section that might be called 'performance of the FDA', to which 'criticism' might be relevant. So the rules of summary style aren't being followed. It isn't a logical split-off of excess content from the main article; it seems to be an attempt to solve a political problem on the Talk page.

There should never be a problem of too much material. It is always legitimate to create *proper* sub-articles, but this one doesn't seem to be one. I suggest you guys should reorganize the main article and then do a split if necessary. And what's with hiding the Table of Contents and including the *complete* list of commissioners? Not a good use of space. EdJohnston 02:40, 5 April 2007 (UTC)

I've been arguing for a while that the relevant place for some of the material on the criticism section is the history section, while other elements of it are philosophical issues that I'm not sure are appropriate for the page at all. I've just made a large addition to the main page along those lines & would be interested in your feedback. Thanks -Rustavo 21:09, 7 April 2007 (UTC)

Deletion of studies by MastCell

So, it was complained by MastCell and Rustavo that I'm not supplying studies from peer-review journals. However, when I add them to the article MastCell deletes them. He says he's doing this because I'm not allowed to interpret them and that I'm doing "original research." Sorry but there is no rule on Wikipedia that say sources have to be secondary sources. Regulations 03:45, 29 March 2007 (UTC)

Actually, there is. It's WP:RS#Types of source material. It's all worth reading, but I'll quote the following: "Wikipedia articles should rely on reliable, published secondary sources wherever possible. This means that we only publish the opinions of reliable authors, and not the opinions of Wikipedians who have read and interpreted primary source material for themselves." I don't make this stuff up. MastCell ^Talk 03:47, 29 March 2007 (UTC)

You may not make it up, but you choose to refer to a "guideline" rather than official policy. WP:OR, which is official policy, says "All articles on Wikipedia should be based on information collected from published primary and secondary sources. This is not "original research"; it is "source-based research", and it is fundamental to writing an encyclopedia. Although most articles should rely predominantly on secondary sources, there are rare occasions when they may rely entirely on primary sources (for example, current events or legal cases). An article or section of an article that relies on a primary source should (1) only make descriptive claims, the accuracy of which is easily verifiable by any reasonable, educated person without specialist knowledge, and (2) make no analytic, synthetic, interpretive, explanatory, or evaluative claims. Contributors drawing on entirely primary sources should be careful to comply with both conditions." This is definitely an article which may rely on many primary sources, that is, studies. Regulations 03:51, 29 March 2007 (UTC)

This is just another version of the ongoing debate about what constitutes a quality source. Primary sources are great, but they need to be appropriate ones - if we're making a point in medicine and economics, we should be looking for widely cited articles in the mainstream scholarly medical or economics literature. Your sources continue to be either informal, unreferenced "op-ed" columns or articles from obscure ideological journals which are not widely cited by mainstream academics or policymakers. And you often feel the need to write out the entire arguement of said articles, often with your own ideological elaboration, rather than composing a concise statement and referring the reader to your source for more details. You have tried to use informal quotes from two "Nobel Prize-winning Economists" - but when these kinds of guys want to make a serious argument in an area of their expertise, they do it in a well-referenced article in a mainstream economics journal, which allows their peers (and us!) to formally evaluate and build on their work. What I find most frustrating is that I am sure there are referenced, academic papers which contain some of the same points you are proposing, albeit in more formal and nuanced form. I wish you would take the time to find them rather than continually drawing from libertarian think-tank position papers and the like. -Rustavo 06:17, 29 March 2007 (UTC)

That's not what we're talking about. We're talking about actual studies that I'm inserting and MastCell is deleting such as Wang H, Nair MG, Strasburg GM, et al. Antioxidant and antiinflammatory activities of anthocyanins and their aglycon, cyanidin, from tart cherries. J Nat Prod. 1999 Feb;62(2):294-6., Seeram NP, Momin RA, Nair MG, Bourquin LD. Cyclooxygenase inhibitory and antioxidant cyanidin glycosides in cherries and berries. Phytomedicine. 2001 Sep;8(5):362-9, and Seeram NP, Zhang Y, Nair MG. Inhibition of proliferation of human cancer cells and cyclooxygenase enzymes by anthocyanidins and catechins. Nutr Cancer. 2003;46(1):101 which show that the health claims for cherries in the examples in the article are true. These are studies in peer-reviewed journals. You guys say you want studies, but then when I put them in the article MastCell deletes them with the reason that they're primary sources. Regulations 14:55, 29 March 2007 (UTC)

No. Those studies show that some chemicals in cherries are effective in laboratory models of inflammation or cancer. They don't show that cherries "ease the pain of arthritis without side effects" or "flush cancer cells out of the body". What you're doing is like saying, "Some bread molds contain penicillins.(reference) Therefore, science shows that eating moldy bread can cure bacterial infections - only the FDA is too obtuse to let bread manufacturers claim that." Do you see the interpretive leap you're making from the primary sources? Those primary sources say nothing about the FDA or regulation, yet you're employing them to make the case that the FDA overregulates in a way that ignores science - a textbook violation of WP:SYN and WP:RS. By the way, "guideline" doesn't mean follow when convenient. It means it should be followed unless you can make a convincing argument that this is one of the very few cases where we should disregard it. MastCell ^Talk 15:05, 29 March 2007 (UTC)

So now you acknowledge that primary sources can be used. If the article points out examples of claims that cherry sellers are making then it makes sense to provide evidence of whether the claims are true or not, to show their not just making this up. I'm going to go through these one at a time, to avoid confusion: One of the claims the article gives an example of is "If you're plagued with chronic pain of arthritis, headaches, or even gout, pros say a daily bowl of cherries COULD ease your ache without side effects." Ok, here's a study: Tall JM, Seeram NP, Zhao C, et al. Tart cherry anthocyanins suppress inflammation-induced pain behavior in rats. Behav Brain Res. 2004 Aug 12;153(1):181-8. [8] The pain from arthritis, headaches, and gout comes from inflammation. Here is another study about the anti-inflamatory effect of cherries: Wang H, Nair MG, Strasburg GM, et al. Antioxidant and antinflammatory activities of anthocyanins and their aglycon, cyanidin, from tart cherries. J Nat Prod. 1999 Feb;62(2):294-6. [9] Here is another study: Kelley, D.S., et al. 2006. Consumption of Bing sweet cherries lowers circulating concentrations of inflammation markers in healthy men and women. Journal of Nutrition 136(April):981-986. [10] "Are you going to delete these studies if I insert them to show that there is evidence of the claim? If so, why? (If there is evidence that it may work, then what's the harm of notifying customers of this so people in pain can give it a try? If it doesn't help relieve the pain and inflammation for everybody, then at least they ate something healthy. This is the kind of destructive censorship that the FDA engages in. And, Allah willing, this prior retraint on speech will eventually be found unconstitutional and we can add the ruling to the history section.). Regulations 15:23, 29 March 2007 (UTC)

Primary sources are fine, but your citations do not provide evidence for the things you and the cherry manufacturers attribute to them. None of the studies you cite were designed to demonstrate efficacy of cherries at treating human disease. The authors of these studies do not make these sorts of claims. Did you actually read the full studies, or did you just see them referenced at a libertarian site, so you linked to the abstracts? -Rustavo 20:21, 29 March 2007 (UTC)

Exactly. Primary sources are acceptable so long as you stick to what is in the source and don't draw your own interpretations or conclusions. Which is what you did. This is actually all spelled out in WP:SYN and WP:RS and might be worth looking at again. MastCell ^Talk 20:28, 29 March 2007 (UTC)

Did you even bother to read the abstracts? I quote from the first study I listed: "The use of complementary and alternative medicine (CAM) has increased in the United States and more patients are seeking CAM therapies for control of pain...These data suggest that tart cherry anthocyanins may have a beneficial role in the treatment of inflammatory pain." Or how about the third one: "Healthy men and women (n = 18) supplemented their diets with Bing sweet cherries (280 g/d) for 28 d. Cherry consumption...study suggest a selective modulatory effect of sweet cherries on CRP, NO, and RANTES. Such anti-inflammatory effects may be beneficial for the management and prevention of inflammatory diseases." That is consistent with the claim that "a daily bowl of cherries COULD ease your ache without side effects." Regulations 20:32, 29 March 2007 (UTC)

I read the abstracts and full conclusions of the studies, and skimmed the rest. Here's the pithy summary of the findings from the first: "The present studies demonstrate that anthocyanins extracted from tart cherries reduced inflammation-induced thermal and mechanical hyperalgesia in rats." So a concentrated chemical extracted from cherries appeared to reduce rat pain in an experimental model of inflammation. No data using whole cherries or cherry juice. No data from humans. No data concerning headaches, arthritis, or gout. They authors engage in speculation (clearly identified as such) at the end of the article about what future research might show. The other study you quote was done with cherries, in humans, but did not look at pain, gout, headaches, or arthritis. A few decreases were seen in the levels of immune system hormones, which "might" mean that cherries fight inflammation, it "might" mean that the patients' immune systems were supressed, it "might" have been an artifact of several limitations of the study which the authors discuss at length, and it "might" mean nothing significant at all for their health. Both studies conclude by saying that further research is warranted and neither reccomends the use of cherries for the treatment of human disease on the basis of their results. It is generally preferable to quote from the text of a study rather than from the abstract, which is condensed and simplified - this has the added benefit of demonstrating that you actually read the study.-Rustavo 21:19, 29 March 2007 (UTC)

"Might, yes." And, the claim from the cherry provider is "could." That generally means the same thing. Regulations 23:06, 29 March 2007 (UTC)

Those sources say nothing about the regulation of cherries or the FDA. You need a source making the connection between those studies and the FDA's regulation of cherries. You're reading those studies and saying, "based on these data, the FDA is out of line." That's original research and your opinion. Just provide a published, reliable source indicating that they think the FDA is overregulating or out of step with the science of cherries, and it can go back in. MastCell ^Talk 20:49, 29 March 2007 (UTC)

I never stated in the article that the FDA was out of line. I merely noted that there was evidence that cherries may be beneficial in those ways. I don't need a source that says the FDA is overregulating the cherries, since that claim is not being made. Regulations 23:06, 29 March 2007 (UTC)

Come on. You wrote that the FDA stance "flies in the face" of the scientific evidence; the implication is clear. If your primary sources make no mention of the FDA or its regulatory capacity, and don't criticize the FDA, and you don't have any secondary sources making such a link, then they're inappropriate for this article. They might be more apropos at cherry. MastCell ^Talk 23:14, 29 March 2007 (UTC)

Don't misquote me. I did not say "flies in the face." I said "This is in the face of.." All the sources quoted in this criticism section of this article don't need to be criticisms of the FDA. Some can simply be informational. Regulations 23:31, 29 March 2007 (UTC)

You're correct about the exact phrasing, although it does not alter my point in any way. All of the information in the "Criticism of the FDA" section should be criticism of the FDA. "Informational" resources about cherries should go in the cherry article. MastCell ^Talk 23:44, 29 March 2007 (UTC)

Absolutely not. If the information is related to the criticism of the FDA then it should be in this article. Regulations 02:48, 30 March 2007 (UTC)

Sigh. The problem is that you decided that the cherry articles are related to the FDA, because it fits in with your personal viewpoint and a point you'd like to make. The authors don't mention the FDA. That's original synthesis and a textbook violation of Wikipedia's policies. If you don't get why it's a problem, maybe we should get some outside opinions. MastCell ^Talk 04:27, 30 March 2007 (UTC)

History section

OK, part one of the new history section is up - I'll add content up to the present over the next week or so. My sources at this point are mostly from documents on the FDA website, although I'll also be looking for corroborating sources as time goes on - I look forward to seeing others' contributions. Let's try to keep this section as objective and NPOV as possible. Also, I'll leave blind hyperlinks in for now - we can either add the new pages or delink them as appropriate as things come together.-Rustavo 06:27, 29 March 2007 (UTC)

Just posted history section, volume II. I have a few more references to sprinkle in here and there, so feel free to mark anything that you think needs a ref. The Food post 1938 section is missing and it might be a while before I get to it since it's not really my area of interest - other contributors to that section are strongly encouraged. -Rustavo 21:02, 7 April 2007 (UTC)

Off-label use

I don't quite understand this paragraph:

For example, the drug propranolol was approved for limited use in 1968 but not allowed to be used for angina or hypertion, until it was approved for angina in 1973 and approved for hypertension in 1976. A study by Arthur D. Little estimated that approximately 10,000 American died every year that the FDA prohibited doctors from treating their patients with it.

If the FDA approved propranolol, then it could be used off-label for angina or hypertension at the discretion of any practicing physician. The FDA can't "prohibit" doctors from using an approved drug off-label - they can only prevent drug makers from advertising and promoting an off-label use (which may be why the source here, PhRMA, was so upset). Propranolol was actually in active trials for angina from the moment it gained "limited" approval (see PMID 787954, PMID 816188). As soon as the results of those trials became available, it gained expanded approval - although again, any doctor could have used it for angina earlier if he/she felt it was appropriate, and they were not "prohibited" by the FDA from doing so. Sure, if we had psychic powers in 1968 and could have predicted that the angina trials would show benefit, propranolol could have been approved on the spot. MastCell ^Talk 15:31, 30 March 2007 (UTC)

Point taken. The wording was not accurate. I'll change simply "prohibit" to "prohibit advertising and promoting." That prevented people from knowing about and therefore requesting the drug that could save their lives. If the drug was already said to be safe by the FDA then what is the point of preventing people from having information that may save their lives? Shouldn't the individual himself be allowed to make the decision whether the potential rewards of the drug saving his life is worth the risk of it being non-effective though safe? You're right that the FDA does not have psychic powers. It doesn't have the power to know what level of risk that any given individual is willing to take. It overrides individual decisions-making and people die unnecessarily as a result. This is a whole new criticism that can be added to this article. Regulations 15:50, 30 March 2007 (UTC)

But people weren't prevented from knowing about it, the company was just prohibited from advertising its drugs as being effective for this indication. Doctors could freely discuss this information among themselves and others can freely disseminate this information, which is protected under free speech of the first amendment (which I believe is specifically talked about in the Washington Legal Foundation cases). Remember 16:07, 30 March 2007 (UTC)

Manufacturers were prevented from telling doctors about it. They were prevented even from sending peer-reviewed studies to the doctors. These leaves not only patients but doctors in the dark as well. Yes the Washington Legal Foundation case loosened a lot of restrictions. This was on appeal by the FDA fighting the loosening of the restrictions on speech. The FDA fights at every turn to retain and/or increase it's powers. Regulations 16:23, 30 March 2007 (UTC)

Doctors are responsible for, and generally capable of, keeping up with the peer-reviewed literature on their own - without the help of kindly, totally altrustic and unbiased drug companies sending them literature. Yes, manufacturers are prohibited from claiming efficacy which has not been proven - this is a "restriction" of free speech which has wide acceptance in the form of false-advertising and consumer-fraud legislation. MastCell ^Talk 17:09, 30 March 2007 (UTC)

Doctors cannot keep up with all the information that's out there. Studies need to be sent to them so they can make an informed decision. There are loads of drugs that doctors don't know about that can help their patients. False advertising is already illegal and always will be. This is not a matter of false advertising. I suppose you want to reverse the 2000 court case that allowed greater dissemination of information because the FDA's censorship was found unconstitutional, which the FDA fought. Do you work for the FDA? Regulations 17:16, 30 March 2007 (UTC)

Pharmaceutical companies are not a good source of unbiased medical information. You're saying that drug companies should have been able to claim benefits from propranolol before those benefits were proven to exist. What is that if not false advertising? If physicians were convinced benefits existed even before the studies were completed, then they had the latitude to prescribe propranolol based on their invididual judgement. I don't see a horribly broken system here. No, I don't work for the FDA (and such questions are a bit uncivil) - I'm ambivalent about it and think there are many valid criticisms of it, especially in terms of its political susceptibility (e.g. Plan B emergency contraception). I just don't like seeing this Wikipedia article used as a soapbox to uncritically rehash a bunch of fringe criticisms in a way that violates WP:WEIGHT. MastCell ^Talk 17:32, 30 March 2007 (UTC)

You think doctors are too stupid to consider the source? You're insulting doctors. I don't know of any doctor that believes that the government should prevent information and studies about drugs, that could help their patients, from being sent to them, regardless of who's sending them. You've got this pro Big Brother mentality that is offputting. I am not "saying that drug companies should have been able to claim benefits from propranolol before those benefits were proven to exist." I am saying they should be allowed to send peer-reviewed studies to doctors that find evidence of usefulness for drugs in off-label uses. Also, they should be able to say that things like "there are studies that indicate propranolol may be effective in treating angina" if such studies exist. If they don't exist, then that is a fraudulent claim. False advertising is already against the law and always will be. Do you oppose the U.S. Constitution too? Do you disagree with the court decision that determined that illegal censorship was occuring? Regulations 17:43, 30 March 2007 (UTC)

And please don't talk to me about WP:WEIGHT until you find one economist that's supportive of keeping FDA's level of restrictiveness or tightening it. Such support simply does not exist. Regulations 17:49, 30 March 2007 (UTC)

You seem to be focusing on my personal beliefs, which is again taking this discussion into an area which the talk page guidelines suggest we avoid. I'd suggest avoiding further comment on what you perceive to be my "pro-Big-Brother" mentality or dislike for the Constitution. Regarding the only actual article issue you raise: you are claiming that a broad consensus exists among economists that FDA regulation is harmful. According to WP:RS, if you're claiming a consensus exists, then you need to provide some sourcing that such a consensus exists. An article in a libertarian journal from a libertarian economist saying he personally doesn't know of anyone who disagrees with him does not prove consensus. MastCell ^Talk 18:42, 30 March 2007 (UTC)

If someone opposes the FDA, then that makes them a libertarian in your book by definition doesn't it? Which came first, the chicken or the egg, libertarianism or opposition to the FDA? Your criticism is circular. Secondly, the source saying that a consensus exists is indeed published in a "libertarian" journal. But, as I'm sure will be much to your dimay to hear, it was also published in Knowledge, Technology, & Policy journal Volume 13, Number 1/May 1, 2000. pp. 92-101. ISSN 0897-1986 [11]. Thirdly, the economist did not say that "he personally doesn't know of anyone who disagrees with him." He said he researched to find studies that supported the FDA, and there is no indication that he only consulted the writings of people he knows personally. Regulations 18:51, 30 March 2007 (UTC)

The source you're citing there seems to be a collection of writings from selected economists specifically opposed to the FDA, so I don't see how it's representative of a broad consensus in the field. Perhaps you're right about labeling as "libertarian" being fruitless; nonetheless, I don't think the sources you've cited demonstrate a clear consensus in the economics community. MastCell ^Talk 19:01, 30 March 2007 (UTC)

If there no economists can be found, by you, me, or Klein, supporting the present restrictiveness or increased restrictiveness, and if the only economists that can found writing about the FDA favor liberalization, then how can you conclude otherwise than that is the consensus of economists that write about the FDA that they favor liberalization? Regulations 19:10, 30 March 2007 (UTC)

Reading Material for Regulations

OK, you asked for it. Last year a special report on U.S. drug regulation was issued by the Institute of Medicine, one of the four National Academies, which are independant organizations federally chartered to advise the nation on matters of medicine, science and engineering with respect to public policy. The acadamies' members include the leading academic experts in every major field of the social, physical, and biological sciences. Your pal Gary Becker is a member of the National Acadamy of Sciences (one of 21 members who specialize in economics), as are most American Nobel prize winners in the sciences who remain academically active. You can read more about the national acadamies here,[12], about the IOM here,[13], and about the NAS here.[14]

The IOM report was authored by a committee of 16 experts, all of whose primary academic/professional interest is in health care but were trained and/or hold primary faculty positions in fields including clinical medicine, medical research, economics, biostatistics, law, public policy, public health, and the allied health professions. The committee also included former executives from the pharmaceutical, hospital, and health insurance industries. A draft of the report was also sent to a wide variety of organizations from across the political and professional spectrum (including the Competitive Enterprise Institute) so that they could make critical suggestions to the authors prior to publication of the final report. You can read the 29-page executive summary of the committee's findings and reccomendations here.[15] You can purchase and read the full 348 page report here [16] (Full disclosure - I have not read the full report!)

Overall, the authors call for an increase in the regulatory powers, funding, and independance of the FDA in order to address ongoing deficiencies in the safety of drugs on the American market. I hope you will take the time to read the full executive summary yourself, but here are some quotes from their reccomendations which I found relevent to our recent discussions. Enjoy.

"First, there is a perception of crisis that has compromised the credibility of FDA and of the pharmaceutical industry (Harris Interactive, 2005; PricewaterhouseCoopers’ Health Research Institute, 2005). Second, the committee learned that most stakeholders—the agency, the industry, consumer organizations, Congress, professional societies, health care entities—appear to agree on the need for certain improvements in the system. Third, the committee found that the drug safety system is impaired by the following factors: serious resource constraints that weaken the quality and quantity of the science that is brought to bear on drug safety; an organizational culture in CDER that is not optimally functional; and unclear and insufficient regulatory authorities particularly with respect to enforcement. Fourth, the committee found that FDA, contrary to its public health mission, and the pharmaceutical industry, contrary to its responsibility to the users of its products (and its shareholders), do not consistently demonstrate accountability and transparency to the public by communicating safety concerns in a timely and effective fashion."

"The committee recommends that the Secretary of HHS, working with the Secretaries of Veterans Affairs and Defense, develop a public-private partnership with drug sponsors, public and private insurers, for-profit and not-for-profit health care provider organizations, consumer groups, and large pharmaceutical companies to prioritize, plan, and organize funding for confirmatory drug safety and efficacy studies of public health importance. Congress should capitalize the public share of this partnership."

"The committee recommends that CDER develop and continually improve a systematic approach to risk-benefit analysis for use throughout the FDA in the preapproval and postapproval settings."

"The assessment of risks and benefits is an activity that does not end at approval, and risk and benefit cannot be considered in isolation of one another."

"Expanded research opportunities should be linked explicitly to FDA’s regulatory mission."

"FDA lacks the clear, unambiguous authority needed to enforce sponsor compliance with regulatory requirements and instead relies on the prospect of productive negotiations with industry. Although the agency historically has made effective use of its “bully pulpit” to compel sponsor compliance, this process leaves potentially critical regulatory action vulnerable to a subjective and highly variable process of exercising individual or agency influence, and to the vicissitudes of changing politics and attitudes toward regulation. That is why FDA’s authorities must be clarified and strengthened to empower the agency to take rapid and decisive actions when necessary and appropriate."

"The committee recommends that Congress ensure that the Food and Drug Administration has the ability to require such postmarketing risk assessment and risk management programs as are needed to monitor and ensure safe use of drug products. These conditions may be imposed both before and after approval of a new drug, new indication, or new dosage, as well as after identification of new contraindications or patterns of adverse events. The limitations imposed should match the specific safety concerns and benefits presented by the drug product. The risk assessment and risk management program may include: a. Distribution conditioned on compliance with agency-initiated changes in drug labels. b. Distribution conditioned on specific warnings to be incorporated into all promotional materials (including broadcast direct-to-consumer [DTC] advertising). c. Distribution conditioned on a moratorium on DTC advertising. d. Distribution restricted to certain facilities, pharmacists, or physicians with special training or experience. e. Distribution conditioned on the performance of specified medical procedures. f. Distribution conditioned on the performance of specified additional clinical trials or other studies. g. Distribution conditioned on the maintenance of an active adverse event surveillance system."

"The committee recommends that Congress provide oversight and enact any needed legislation to ensure compliance by both the Food and Drug Administration and drug sponsors with the provisions listed above. FDA needs increased enforcement authority and better enforcement tools directed at drug sponsors, which should include fines, injunctions, and withdrawal of drug approval."

"The committee recommends that Congress amend the Food, Drug and Cosmetic Act to require that product labels carry a special symbol such as the black triangle used in the UK or an equivalent symbol for new drugs, new combinations of active substances, and new systems of delivery of existing drugs. The Food and Drug Administration should restrict direct-to-consumer advertising during the period of time the special symbol is in effect."

"The committee recommends that FDA evaluate all new data on new molecular entities no later than 5 years after approval. Sponsors will submit a report of accumulated data relevant to drug safety and efficacy, including any additional data published in a peer-reviewed journal, and will report on the status of any applicable conditions imposed on the distribution of the drug called for at or after the time of approval."

"To support improvements in drug safety and efficacy activities over a product’s lifecycle, the committee recommends that the Administration should request and Congress should approve substantially increased resources in both funds and personnel for the Food and Drug Administration."

Like I said, you asked for it :-) -Rustavo 23:35, 30 March 2007 (UTC)

Asked for what? What is the above all about? Regulations 01:13, 31 March 2007 (UTC)

You asked for an economist that thinks FDA regulatory powers need to be expanded. I provided a definitive 2006 reference from a panel created by the leading independant scientific organization in the country, of which the top American economists are members. The report's authors include economists. Have you read it yet? -Rustavo 01:34, 31 March 2007 (UTC)

I have no interest in reading any of the above. If you have economists that say the FDA should be more restrictive then simply add them to the article. I don't know what your point is of all the above. You don't need my permission to add sources to this article. Regulations 02:06, 31 March 2007 (UTC)

I did add it to the article. And I will be removing your obviously innaccurate claim that most economists think FDA regulations should be reduced. -Rustavo 02:17, 31 March 2007 (UTC)

It's not my claim. It's economist Klein's claim, and the claim can stay. Unless you have some way of proving that it's not true. Regulations 02:25, 31 March 2007 (UTC)

I'm not sure you will convince others that you are intersted in contributing to an WP:NPOV article about the FDA if you are not even willing to read recent, authoritative reports on the subject you have been continuously trying to write about. Kline's claim simply does not hold up to the reality of mainstream expert opinion such as the GAO report and the IOM report I previously cited. Believe it or not, I do read your references. -Rustavo 02:36, 31 March 2007 (UTC)

What do you mean by "mainstream experts." If someone opposes the FDA, then by your definition that are not mainstreadm. It's circular. Regulations 02:47, 31 March 2007 (UTC)

Not really. I posted the GAO reference because it provides support for many of your arguments - but does so in context with the current debate, and in a well-referenced manner. Read it - you might be pleasantly surprised. But please also read the IOM report. Most people seriously engaged in the process of FDA reform do not think in terms of "more" or "less" regulations per se, just "better" and "more effective" ones. They're not out to score ideological points and would not consider themselves "supporters" or "opponants" of the FDA. Neither do I.-Rustavo 03:55, 31 March 2007 (UTC)

Yes, really, if you expect us to slog through article after article from the Independent Institute, the Competitive Enterprise Institute, Reason magazine, and other such reliable sources, you could at least look through the report from the National Academy of Sciences and the Institute of Medicine. MastCell ^Talk 02:42, 31 March 2007 (UTC)

I don't need to read it. I trust you. I trust that you will represent their arguments accurately. I'm more concerned that the anti-FDA arguments are represented accurately because it appears plain to me that you two are trying to obscure them. Regulations 02:45, 31 March 2007 (UTC)

My hope was that if you took some time to familiarize yourself with the mainstream discussion on FDA reform, you might better understand that inserting such an enormous volume of non-mainstream, tangential, and dated criticism is a violation of WP:NPOV#Undue weight. This really isn't the appropriate place for an original dissertation on philosophical opposition to the very concept of drug regulation. -Rustavo 03:48, 31 March 2007 (UTC)

Milton Friedman's ideas are mainstream. So, are Beckers. The Chicago school, of which both of them are a part, is mainstream in economics today. The Austrian school is borderline mainstream. Regulations 04:08, 31 March 2007 (UTC)

Note that that doesn't mean the mainstream agrees that the FDA should be abolished. It simply means that Friedman's ideas on this are well known in the mainstream. His ideas on the FDA are probably more famous than any other economists ideas, not only among economists but among the general publica as well. His ideas and arguments this are extremely notable, whether anyone agrees with them or not. Regulations 04:42, 31 March 2007 (UTC)

If their ideas are so notable, why haven't they published them in academic journals? Why have the major expert panels commissioned to examine this issue in the past decade taken a completely different view? - Rustavo 16:04, 31 March 2007 (UTC)

Did Adam Smith publish in academic journals? That's for small fish. The economists come up with the great ideas and reasoning. The little guys go out and do most of the empirical analysis that these ideas inspire. Regulations 16:12, 31 March 2007 (UTC)

So you don't think it's significant that there seems to be a complete lack of "little fish" inspired to produce empirical analysis for these particular so-called "great ideas"? Or that their authors never chose to write them down formally (correct me if I'm wrong, but I don't think "Wealth of Nations" was an op-ed column in Business Week magazine). —The preceding unsigned comment was added by Rustavo (talk • contribs) 20:01, 31 March 2007 (UTC).

Note also that I would like to see not only the Over-regulated section full of criticism. But, I would also like to see the Under-regulations section stuffed full of criticims of the FDA as well. The only makes clear the fact that the FDA creates an unresolvable dilemma. Regulations 05:31, 31 March 2007 (UTC)

Or that lots of people have strong opinions on this issue and policy makers have taken a position somewhere in the middle. You can't seriously think that groups which want the FDA to regulate drugs more tightly somehow support your contention that it should be abolished.

Of course they don't. But the person that looks at the bigger picture can see that the dilemma is unresolvable. What's causing it is lack of the ability of doctors and patients to decide for themselves what risks they are willing to take. When that choice is there, what is there to complain about? Everybody is being allowed to live their own lives as they see fit. Regulations 16:12, 31 March 2007 (UTC)

Having the underregulation section also makes clear the point that Friedman and others have made, which is that it's a big scandal if the FDA approves a drug that was found later to be unsafe, but when people are harmed because the FDA doesn't approve a drug you don't hear about it. Regulations 16:36, 31 March 2007 (UTC)

Just want to put it out there that it appears Regulations has made very few edits outside of this article and there might be some WP:COI issues behind the scenes. // 3R1C 15:14, 31 March 2007 (UTC)

Sure there is a conflict of interest. I'm a healthy human being interested having access to the best that technology has to offer to preseve my health. Regulations 16:15, 31 March 2007 (UTC)

The statement was made under the assertion you have made very little edits outside this article, and even fewer outside the generalized topic. You dispute this? // 3R1C 18:13, 31 March 2007 (UTC)

No, I don't dispute it. This is my main interest right now. What's your point? Regulations 18:18, 31 March 2007 (UTC)

The point is that you are using Wikipedia as a soapbox to engage in advocacy for a social/political cause you believe in. Wikipedia is not a vehicle for advocacy, nor a place to Right Great Wrongs. There are plenty of other venues for activism which might be more fruitful and appropriate. MastCell ^Talk 18:29, 31 March 2007 (UTC)

No I'm not. I'm just providing information that is lacking from this article. Much of it just happens to correspond to my POV. However, the reason you and your pro-government allies are opposing the information is because it oppose your POV. You're in the wrong here, not me. You're trying to get rid of and obscure sourced information. Do you see me deleting sourced information that opposes my POV? No, you don't. I noticed that Rustavo seems to be maybe coming to his senses, by simply adding counter-arguments and differing sourced interpretations instead of deleting/obscuring sourced information he doesn't like, as he had been doing. Let's hope he doesn't revert to his old ways. Regulations 18:35, 31 March 2007 (UTC)

Revisionist history will get you nowhere. I've been adding authoritatively sourced material, both pro and con, to all of the criticism sections since I first started editing this page. I've also been continuously trying to make the sections more concise and legible, and I've been deleting weak sources for which I couldn't find better references, as well as dated and tangential arguments. I'm holding off on the latter for now because trying to keep up with you was taking up too much of my time, not because your writing has gotten any better. -Rustavo 19:46, 31 March 2007 (UTC)

Rustovo's edits

What is with changing the name of one of the criticism sections to this: "Criticism: FDA rejects lifesaving medicines."? That's not the criticism. Of course the FDA rejects livesaving medicines. I don't think anyone would dispute that. That's an expected side effect of regulations. The criticism is that the amount of regulation rejects too many good medicines in order to prevent bad medicines out of the market. It the FDA caused more good than harm, it wouldn't be a problem if some people died as a result of the regulations. The criticism is that more harm is done than good. Regulations 01:13, 31 March 2007 (UTC)

Your title was way too vague. The FDA has far more regulatory responsibilities than just approving drugs. The title of the section needs to establish that it is talking about drug regulation, and to differentiate it from the other sections that discuss other aspects of FDA drug regulations. -Rustavo 01:30, 31 March 2007 (UTC)

And what is the point of this: "Economist Robert Higgs argues that FDA regulations and policies do not allow individuals to obtain drugs fitting their own risk/reward judgements."?? That's not his argument. That's a given. Everybody knows that individuals are not allowed to obtain drugs if they're not approved by the FDA. That's not in dipute. His argument is that when the FDA prohibits the purchase and sale of drugs that that not not approved, that the well-being of consumers ,with well-being is properly understood as consumers' prospective and subjective marginal utility, is reduced. Regulations 01:22, 31 March 2007 (UTC)

I view much of your writing as unnecessarily long - I actually think it hurts your argument. Make your point concisely and link to the full source for those who are interested. Your previous statement was innacurate - the FDA will approve a drug even if it is only safe and effective for a small but identifiable group. See today's statement about the recall of Zelnorm. -Rustavo 01:30, 31 March 2007 (UTC)

The argument, that is the argumentation, was not even there. What I meant to say is that you deleted the conclusion. The argumentation is too esoteric for this article. The whole conclusion of the analysis is that prohibiting individuals from obtaining drugs because the FDA has not approved those drugs, reduces consumers' welfare. Regulations 01:34, 31 March 2007 (UTC)

Is it too much to ask that you refrain from continually inserting FDA criticisms from over 25 years ago as if they applied to today's FDA? It's hardly relevant what Friedman though of FDA regulation procedures in 1980, so much has changed since then in every aspect of medicine. Leave in a broad thematic quote if you want ('the following flaw is inherent in the idea of drug regulation' etc.), but don't devote entire paragraphs to outdated criticism. -Rustavo 01:44, 31 March 2007 (UTC)

What Friedman said 25 years ago is totally relevant. It's not a study. It's economic REASONING. It applies today and always. His argument is that by the FDA's nature, it can never do more good than harm. It can't be reformed. His writings from back then are still cited today very often, and will continue to be for hundreds of years. There is no reason why they shouldn't be cited here either. Regulations 01:48, 31 March 2007 (UTC)

That's not an economic arguement, its a philosophical belief. A economic argument has methodology and data to back it up, and generally applies to a concrete situation. This is not a page on "drug regulation" in general - it is about the specific FDA organization.

I don't think Friedman ever set out to formally show that drug regulation "could never do more good than harm" in an academic paper. Peer reviewers would have laughed him out of the room. If I am mistaken, please provide the reference. What exactly do you have against academic papers from this century? - you haven't provided many to back up your statements. -Rustavo 01:55, 31 March 2007 (UTC)

There is no requirement that the criticism in this article have to be from studies, surveys, and statistics. Reasoned arguments from professional economists are allowed, especially when its from the most influential economist of the second half of the 20th century, if not the whole 20th century. You're absolutely wrong that "A economic argument has methodology and data to back it up." Never read Adam Smith's Wealth of Nations? Talk about an influential economist. His methodology was mainly logical argumentation. The greats don't even need to decend to the level of dealing with statistics, etc. Regulations 02:03, 31 March 2007 (UTC)

Criticism subsec titles

Changed the blatantly weasel worded and bias statement Criticism: FDA allows too many to suffer and die in order to prevent unsafe medicines from coming to market to Allegations FDA regulation harms patients through lack of options. Not only is it shorter, it's less pointed. More to come. Will outline here // 3R1C 21:22, 31 March 2007 (UTC)

It's a bad change. It's less clear and misses the point. Of course the FDA harms people. It's ok if the FDA harms people, if it makes up for it by helping more people than it harms. The criticism is that it causes more harm than good. Regulations 23:11, 31 March 2007 (UTC)

Your statement that the FDA is inherently harmful is completely pov. // 3R1C 23:34, 31 March 2007 (UTC)

A criticism by its very nature is POV. So I'm not sure what you mean. Unless you mean it should be something like "Critics claim that..." Regulations 00:01, 1 April 2007 (UTC)

No, because those are weasel words. While you might think I need to read this article more, there are several policies you might want to read up on, including WP:NOR, WP:V, and the aforementioned WP:WEASEL. This are policies of Wikipedia used to avoid things like POV issues and keeping Wikipedia neutral. // 3R1C 00:24, 1 April 2007 (UTC)

If it's sourced that there are such critics then it's not "weasel words." Weasel words are when you say "Critics say" or "some say" without showing that such people actually exist. Regulations 03:24, 1 April 2007 (UTC)

Yes, that's correct. If it's attributedm that's a-ok. // 3R1C 13:10, 1 April 2007 (UTC)

Changed Criticism: FDA regulation delays in drug approval to FDA regulation allegedly slows drug development // 3R1C 21:23, 31 March 2007 (UTC)

That's a bad change as well. But, the original was bad as well. Of course regulation delays drug approval. The more strict the standards the slower a drug comes to market. The criticism is that the delay is too long, such that it harms more people than it helps. Regulations 23:11, 31 March 2007 (UTC)

Okay, I can agree with that one, I appended "excessively" to indicate it takes longer than it should. // 3R1C 23:34, 31 March 2007 (UTC)

Changed Criticism: FDA regulations requiring "proof of efficacy" causes unnecessarily high drug prices to FDA "Proof of Efficacy" requirements increase costs" // 3R1C 21:24, 31 March 2007 (UTC)

That's a bad change. Of course proof of efficacy requirements increase costs. That's not in dispute. The criticism is that costs are too high to justify the benefits. Regulations 23:11, 31 March 2007 (UTC)

Again, I can accept that. I can append another modifier to the end to cover the extent of the cost effect. // 3R1C 23:34, 31 March 2007 (UTC)

Changed Criticism: FDA regulations reduced the number of new drugs introduced and reduce research spending to FDA approval procedures affect research and development cycle." // 3R1C 21:26, 31 March 2007 (UTC)

Bad change. How is "FDA approval procedures affect research and development cycle" a criticism? It's not. Of course it affects research and development cycle. You're simply obscuring the point. Regulations 23:11, 31 March 2007 (UTC)

Negatively effect the development cycle sounds fine to me. I'll change that, too. Thanks! // 3R1C 23:34, 31 March 2007 (UTC)

Changed Criticism: FDA regulations disallow drug reimportation to FDA importation regulations increase costs // 3R1C 21:26, 31 March 2007 (UTC)

Removed Criticism: from Criticism: FDA is slow in granting over-the-counter status Perfectly acceptable statement, minus the colonized reference. // 3R1C 21:28, 31 March 2007 (UTC)

Changed Criticism: FDA restrictions on free speech are harmful and/or unconstitutional to FDA advertising restrictions violate First Amendment // 3R1C 21:29, 31 March 2007 (UTC)

Bad change. If you read the section you would see that the complaint is not simply that restricting speech is unconstitutional, but that restricting it causes too many deaths. Regulations 23:11, 31 March 2007 (UTC)

Added ...and patient safety to emphasize the effect this causes to people. // 3R1C 23:37, 31 March 2007 (UTC)

I give up posting all of these. I shouldn't have to. Everyone's statements were blatently biased and in non-neutral points of view. I feel I fixed it (being a neutral party not involved in this incident). If you have issues with these changes, please visit my talk page. // 3R1C 21:35, 31 March 2007 (UTC)

Thanks for trying but I don't think you read the material, otherwise I don't know how you could justify those changes. Regulations 23:11, 31 March 2007 (UTC)

All of your edits were in the same tone, you're just stating their "wrongness" because they don't meet your biased views. // 3R1C 23:29, 31 March 2007 (UTC)

Additionally, the issue with the subsec titles is that they can be much more concise. There is no need to state your entire case in a subsec title. A general touch upon the topic for the subsec title will suffice. If you need to go into further detail, you can do it in the body of the subsection with sourced materials and statements. // 3R1C 23:37, 31 March 2007 (UTC)

I think 3R1C is right on target--thanks, buddy. --Dr.michael.benjamin 02:33, 3 April 2007 (UTC)

Not to discourage you, 3R1C, but we've all retitled those sections many times to make them more general and NPOV. One particular editor continually reverts them to fit the details of his specific argument. As you have now discovered, -Rustavo 20:57, 7 April 2007 (UTC)

Criticism SectOR tag removed

I removed the SectOR tag because it seems like everyone involved here has gone through and properly cited pretty much eveyr argument thats needed. I think when a main section has over twenty pieces of work attributed to it, we're probably well-off on WP:ATT. The only thing that remains now is properly attributing weasel words in the over-regulation section, but even then, we're almost done. If everyone involved in the development section would go through and search for all sections that use potential weasel words and phrases and attribute them to sources, we'll be good to go (and then maybe we can contemplate forking this 70kb article). // 3R1C 17:59, 2 April 2007 (UTC)

Moved Criticism to its own article

I went ahead and moved the Criticism section to its own article since it was getting too large for this one, and only one person disagreed with the move when we had a vote on it above. It's now at Criticism of the FDA. Regulations 03:21, 4 April 2007 (UTC)

If you have this article on your watchlist, let us know if and when it comes up for deletion. A lot of editors are deletion happy and love clipping out content forks. We need to be prepared to defend this fork (since it really is important to the function of the organization). I'd hate to see all that work wasted on a stupid deletionist // 3R1C 06:04, 4 April 2007 (UTC)

This is an OK compromise for now, but I should point out that it is only "getting too large" because Regulations seems unable to write concisely and unwilling to accept others' attempts to improve his bloated contributions. I would encourage those who are working on the criticism page to keep it concise, balanced, and well-referenced. I personally am not going to waste any more time trying to bring it up to Wikipedia's quality standards, nor will I "defend" unencyclopedic writing. In the future, the criticism page will likely be judged as a whole by other editors, and will be deleted if it has turned into a soapbox or extensively violates WP:NPOV#Undue Weight or WP:Attribution. -Rustavo 16:19, 6 April 2007 (UTC)

removing the article "the" from before "FDA" in the article

FDA, like FBI, does not take the definite article "the." I propose removing these before the word FDA. It might read oddly, but it would be correct form/grammar.

Afterlaws 16:49, 23 April 2007 (UTC)

According to the Chicago Manual of Style, the form "FDA" is INCORRECT from a grammar standpoint, regardless of what the agency wants to call itself. The term "FDA" is an initialism, not an acronym, and initialisms are normally proceeded by an article whereas acronyms aren't. The general rule is that if "the" is part of the name, but not absorbed by the abbreviation, one should use "the" as if the abbreviation were spelled out. You don't say "NFL consists of 32 franchises," for example, or "I was listening to BBC on the radio this morning." If you're using the abbreviation as an adjective, of course, it's different ("NFL games are normally played regardless of the weather"; "BBC commentators reported on the Prime Minister's journey."). The abbreviation "FDA" doesn't absorb the article "the" and the correct form is "the FDA." The Supreme Court uses this form as well in their opinions. Regarding the FBI, I don't think I've ever heard anybody argue that there should be no article there. (Now, if you work for the FDA, I suppose you should do whatever your boss requires, but that's a separate question from which style Wikipedia ought to use.) 1995hoo (talk) 13:46, 17 June 2008 (UTC)

I think since the FDA is the only FDA, and therefore unique, "the" is still acceptable. Sure, the term FDA does not include the article "the," but the article "the" is not being considered part of the term "FDA," but to the fact there is but a single FDA. // 3R1C 18:27, 23 April 2007 (UTC)

Additionally, you cite the term FBI as a similarity, but the FBI article begins in the same fashion. Considering that article is rating A, I'm sure using the article "the" is aceptable // 3R1C 18:30, 23 April 2007 (UTC)

I actually tried to change that a few months ago, but I realized that plenty of media outlets and other 'reliable' sources, as well as the vast majority of editors, prefer to use "the FDA". I think it would require constant maintenance to keep it consistant in the article if we switched to the "official", but unorthodox, no-definite-article style. -Rustavo^{Talk/Contribs} 23:00, 30 April 2007 (UTC)

Quarantining Criticism - here we go again

First, I just wanted to ask whether the discussion from the Criticism of the FDA page was copied anywhere before that page was deleted? It seems to me that it would have been most appropriate to have copied it to this talk page, as now we need to start the conversation again somewhat from square one. Second, I noticed that Dr.michael.benjamin has moved the PDUFA content, including a significant portion that could fairly be called "criticism" back into the sections defining the core regulatory authority of the FDA. I don't think we entirely reached consensus about how to go forward, but I continue to think that we should have defined sections for "reform" or "current debates" or whatever we want to call it, and that sort of content should probably not be placed in the first few sections which describe, in a straightforward manner, what the FDA does, and what its authority is. -Rustavo^{Talk/Contribs} 23:20, 30 April 2007 (UTC)

Sorry, Rustavo--didn't mean to cheese you off. You are one of the "good guys" around here, and your work is good. I think a discussion of programs like PDUFA should include a "neutral" presentation of context. These issues aren't just relegated to some anarchist's screed--PDUFA is up for reapproval this year, and maybe people would like to understand the context of why it's somewhat controversial. I envision a college undergrad taking some pharmacy policy course looking to understand the strengths and weaknesses of the program reading the section and saying, "Hmm, that's why there is so much fighting going on about this obscure piece of legislation." Also, there are a bunch of newspaper and magazine articles about "tail wagging the dog" when it comes to the relationship between industry user fees and the Federal Government. Michael Pollan has a bestselling book out that discusses the erosive effect these user fees are having on the agricultural industry. It's the same problem in the USDA. Look, I don't really know which side of PDUFA is right: it saves taxpayers hundreds of millions of dollars, but it also leads to the erosion of integrity in the approval process. It's not going anywhere. I honestly don't have an axe to grind--I just think that the reader has a right to consider the topic in context with relevant, coherent debate. I tried to minimize the weasel words and go with an historical narrative of facts. I continue to believe that we should redact the criticism page into the main article, to give more depth and context to each concept. How did we get to this point? To what extent did the critics enhance the function of the FDA, or did they just go away?

I agree that criticisms can provide a soapbox for someone with a POV problem. You probably also agree that responding to criticism makes an individual or organization stronger. There must be a happy medium in there somewhere.--Dr.michael.benjamin 04:09, 1 May 2007 (UTC)

Sorry if I sounded annoyed - my main irritation was at the deletion of the criticisms page before we had really reached a consensus on what to do with the content. As problematic as it was, I don't think anyone had suggested simply erasing it entirely without merging anything, and without preserving the discussion. -Rustavo^{Talk/Contribs} 04:49, 1 May 2007 (UTC)

Who deleted the Criticisms that used to be here? That's real bright. Looks like someone waged a successful POV pushing campaign. Anyway I just wanted to point out that the latest effort to expand FDA powers is bill S0182. http://www.lef.org/featured-articles/consumer_alert_042707.htm —The preceding unsigned comment was added by Hardrack (talk • contribs).

Hello. Have we met before? MastCell ^Talk 02:01, 1 May 2007 (UTC)

Hello. I doubt that.

Here is a history of FDA power if anyone is interested. http://www.emord.com/events/speeches/fda_violation.htm —The preceding unsigned comment was added by Hardrack (talk • contribs).

Mr. Hello, we will plan to delete your comments as vandalism if you don't sign them...You will find that the criticism section is in a different page, until we can agree on where it belongs. --Dr.michael.benjamin 04:10, 1 May 2007 (UTC)

An interesting perspective on the PDUFA here in this week's NEJM... MastCell ^Talk 04:12, 1 May 2007 (UTC)

Actually, there are three perspectives on FDA reform in NEJM, including one by the current Commissioner. This issue is very timely, and there are plenty of sides to it. -Rustavo^{Talk/Contribs} 04:56, 1 May 2007 (UTC)

True enough... I guess I just found Avorn's the most interesting. By the way, Hardrack (talk · contribs), I thought you sounded familiar. Using sockpuppets to evade your ban is a waste of everyone's time. MastCell ^Talk 15:46, 1 May 2007 (UTC)

To the contrary. I editing under many sockpuppets as we speak in many articles that are going on undetected, as I'm sure are many of the other people that were wrongly blocked. The ISP this building subscribes to has a dynamic IP that changes from minute to minute. They would have to block an entire region of the U.S. to get rid of me. They don't know where to look for me because I edit new articles every day. Besides, you know good and well that I wasn't a sockpuppet of Billy Ego. That was clearly administrative mistake ..a sloppy decision and sloppy research. Billy Ego was a self-proclaimed facist. I'm a libertarian which is the complete opposite. We are not the same person, but apparently people in the same geographic region which is apparently all the evidence they need. I see that you're taking full advantage of that administrative error to prevent this article from being NPOV, by reporting my Hardrack username because you know I was making this article NPOV, more informative, and more educational. I choose not to edit this article for the time being, for obvious reasons. But, "rest" assured, I will be back. As soon as you and your two other anti-medical freedom POV buddies leave Wikipedia I'm coming right back. I may even come back before then through a proxy that looks like I'm coming from an entirely different region. I'll even use entirely different sources and information, which there is no shortage of, and even different writing styles, which will leave you dumbfounded. "Is it him or not?" Because I will be coming through a dedicated proxy, if a Checkuser is done it will look like I'm in an entirely different region of the U.S. or even in another country. I will probably have moved to another part of the country by then anyway. I live here only temporarily. So, I will be back. It may be next week. It may be next year. It may be five years from now. As soon are you decide to leave Wikipedia, I'll be here. So you and your two other anti-NPOV friends better be prepared to waste the rest of your lives guarding this article. Because, I'll be back. Have fun. Regulation237 20:45, 1 May 2007 (UTC)

You forgot to add mwahaha. Remember 21:08, 1 May 2007 (UTC)

>:-) Regulation237 21:11, 1 May 2007 (UTC)

Reimportation

Now that reimportation is back in the news, I think the article should provide some context. Feel free to edit the reimportation section--it's more of a stub at this point, and the issue cuts to the very core of how government protects intellectual property. --Dr.michael.benjamin 03:57, 9 May 2007 (UTC)

BTF

The article says the the Bureau of Tobacco, Alcohol, and Firearms is part of the Dept. of the Treasury. It is really part of the Department of Justice (Homeland Security Act of 2002). Its name is actually Bureau of Tobacco, Alcohol, Firearms, and Explosives.

76.21.2.198 22:03, 22 June 2007 (UTC)Contepeitro

Thanks for pointing this out - I've made the relevant changes. Don't be shy about making edits yourself! -Rustavo^{Talk/Contribs} 00:44, 23 June 2007 (UTC)

Quality of Factual Sections

The sections on drug and dietary supplement regulation are very brief and vague. I could expand them. However, even the basic elements of drug regulation as provided by the Food Drug and Cosmetic Act could be several hundred words long. But it is an important topic (about which I have written books). Moorepublic 13:40, 3 October 2007 (UTC)

Go ahead. When in doubt we can split it off to other pages or pair it back if people think it is too detailed for an encyclopedia entry. Remember 13:52, 3 October 2007 (UTC)

Also, the User Fee Act was renewed last week with some far reaching changes in post market surveillance and drug safety. Will add a graph there. TJMoore 23:50, 5 October 2007 (UTC)

Did a very simple edit of the top of the page, added a few references and fixed up a few others. At some point we might want a consistent reference style. Got my feet wet using the style and formatting commands. But the big job is a rewrite and restructuring of the "Regulations" section. (even the title is not very helpful. Will try to get a draft done this week. Also some very useful material on other pages (clinical trials, placebo effect) and I need to check what is already available. Anyone got any problems with that?? TJMoore 14:15, 7 October 2007 (UTC)

Sounds fine to me. Others are watching this page so if you do anything crazy they will speak up. Remember 00:51, 8 October 2007 (UTC)

Rewrite of drug regulation section

Ok folks, I have completed and rewritten the section explaining how the FDA regulates drug products and done a little editing and cleanup of the larger section.

Comments and reactions welcome. If this approach is well received I would go on to rewrite the other regulatory sections (they generally can be much shorter) to explain how foods, dietary supplements are (and are not) regulated. I hope the material I have added is neutral and carefully documented. TJMoore 15:51, 10 October 2007 (UTC)

Proposal: Split off drug approval section

This page is way too long as is, and one section that could easily be split out is the section on the IND/NDA process. In all fairness, the article would have to cover the IDE/PMA, 510k, BLA, NADA, food additives and the GRAS list, and all of the other equivalent approvals. Drug approval is a complicated process within the FDA that gets a lot of media attention and there is a lot to say about it. There is already an NDA page that exists, maybe just move all of this information to that page?150.148.0.27 (talk) 22:39, 13 December 2007 (UTC)