The US Food and Drug Administration (FDA) and similar agencies in other industrialized countries get politically punished more for approving drugs that turn out to have unexpected side effects. At the same time they few rewards for taking risks to approve drugs that might turn out to deliver large benefits. The willingness of politicians to criticize the FDA when drugs turn out to cause unexpected harm probably plays a role in a very large reduction in the rate at which the FDA approves drugs.
Why do terminally ill patients have to wait so long to get access to the only treatments that hold any promise of saving their lives? And why is it not their right to decide?
The problem has been magnified in recent years as the number of new drug approvals has fallen dramatically. The FDA approved just 16 new drugs last year, and is on pace to approve only 18 this year. That's down from a high of 53 in 1996 and 39 in 1997.
After a few high-profile drug scares, such as the 2004 withdrawal of Vioxx from the market, FDA officials have become gun-shy about approving new products. After all, the agency receives scathing criticism from Congress and the press when an approved drug turns out to be more risky than expected -- but rarely for keeping beneficial ones off the market.
This trend does not bode well for the development of rejuvenation therapies. The FDA will hold off approval of an anti-cancer drug for people who have a fatal disease. Never mind that people who have a fatal disease are going to die anyway. The FDA won't let people take a risk when they have little to lose. That makes no sense to me.
Rejuvenation therapies are going to treat that fatal disease called aging. Absent those therapies we are all going to die from complications of aging. Weakened immune systems will allow cancer cells to grow and spread. Weakened hearts and clogged arteries will lead to heart attacks and strokes. Aged brains and probably aged immune systems will allow junk to accumulate in our brains leading to neural cell death and eventual death from Alzheimer's or other brain diseases.
Faced with rising risks of death combined with increasing pain and disablement people should be given wider latitude to try new and unproven therapies. Once diagnosed with terminal illnesses people should be freed from government mandated restrictions on available therapies.
By Randall Parker at 2008 August 23 04:04 PM Policy Medical | TrackBackFDA must be disbanded as an entity that can forbid marketing drugs. An entity that can only certify drugs as safe, efficient, etc... must be established in its place. Anyone willing to treat themselves with a non-proven drug should be free to do so. Anyone who wants to rather be safe than sorry will look for that "NewFDA" label on the packaging.
Right now, I have an acquaintance who is suffering from MS. He cannot try Tysabri because of FDA, and his disease is rapidly progressing in spite of him being treated with other MS drugs.
I have invested in biotech and am frustrated by the delays. Drugs that could help are being tested to the point of absurdity...as if anything in life is risk-free. Agree that there should be a "second-sight" agency.An intermediate level of approval should be instituted for patients willing to take the risks.
We'll probably have to travel to foreign countries to get the treatments. Many do that now.
Allan,
Sure, people will travel. But the need to travel will hugely cut demand. Smaller demand means less product development. Less product development means you'll need some treatment and it won't be available.
No, the powerful competition provided with medical tourism will collapse the FDA by forcing massive pressure on the agency to reform or get out of the way.
The homosexual groups showed how you can successfully put pressure on the FDA. Many homosexuals were dying from AIDS and banded together going to the public meetings held by the FDA. Petitioning and writing the FDA and media through their organizations. Basically constant pressure on the FDA. It introduced a political cost to holding up potentially life saving drugs. But again it took lots of energy and organization.
> Once diagnosed with terminal illnesses people should be freed from government mandated restrictions on available therapies.
As always, Randall... saying the right thing and then getting scared of following it through.
Why only terminally ill people should be freed? How about freeing *everybody*? Not waiting until they'll become half-dead?
FDA must be abolished, plain and simple.
I strongly disagree. While there are some circumstances in which people should be able to obtain drugs (a documented case of a terminal illness where the medication may save a life is one instance), it is impossible for the layperson to be informed enough to make an educated decision on taking most drugs. Even the smartest person can perform multitudes of research, but simply might overlook something for lack of medical experience.
On August 5, 2006, I took two pills of SAM-e, an antidepressant compound that is marketed as "safe" by various nutrition companies. Never having had any history of bipolar disorder, it induced mania, and I was not properly diagnosed for four months, after becoming suicidal and losing my memory of that four-month period. Two years later, I am still not able to concentrate like I was in 2006. Later, I read that such reactions seem to be common with SAM-e, even in people without a history of manic episodes, but all that GNC did was add small print mentioning that those with bipolar disorder should not take the drug. I never had any other episodes of mania other than the one caused by SAM-e. Were SAM-e not classified as a "nutritional supplement," its dubious safety profile would surely result in denial of approval.
I will never again take supplements other than a multivitamin. It's easy to say that people should be able to decide for themselves whether to take the risk, but I visited over a thousand websites before deciding to take the drug, and nearly killed myself.
The FDA's power should be scaled back slightly in cases of terminal and more serious illnesses. Eliminating the agency entirely, however, will cost the taxpayer billions in unnecessary medical expenses treating side effects, addiction, and drug interactions, and will result in far more suffering than would be cured.
I would love to think of a way to properly incentivize health care providers. But as brian says the information asymmetery is SO severe in medicine and unlike say your mechanic you have no way of telling whether your doc even did a good job. Docter can tell you you have cancer prescribe a drug and tell you your "improving" and then "cured" most would have no way of ever telling the difference. Perhaps a government agency to independently evaluate someones health w/regard to their expected health. Another gov agency to pay out a percentage for say $earned in a working lifetime (they take a % if patient has to go on disability) or above average expected health outcomes. Companys could bid against each other (cause various people have different life outcomes irregardless of intervention) to purchase the %income stream for various workers or retirees(adjust a % for Qoflife) (put a ten year average on it for the workers... prevents short term cheating(Keep working on the alaskan fishing boat with your bad foot hey great idea the income streams still great and we need to make earnings target this Q). Course this fails for the very old or ill (subjective well being is probably more important to a cancer patient than the # of years they can keep him patched together and they would keep him patched if only for the income stream). Sounds good....one prob is.....this is a lobbyists fucking DREAM. Opps for corruption are astonishing. VV hard prob to solve. We need better nootropics.....but im just gonna swallow a pot of coffee and see what else I can come up with. :)
> I strongly disagree. While there are some circumstances in which people should be
> able to obtain drugs (a documented case of a terminal illness where the medication
> may save a life is one instance), it is impossible for the layperson to be informed
> enough to make an educated decision on taking most drugs. Even the smartest person
> can perform multitudes of research, but simply might overlook something for lack
> of medical experience.
Collectivist (n):
a person who thinks he's smarter than others so he feels entitled to force other people
to live like he thinks they should while at the same time thinks that he needs an adult
supervisors who would prohibit things for him and punish him if he tries to misbehave.
Who are you, Mr Brian to tell *me* what I can and cannot do with my own body? If you have
the masochist desire of wanting others to tell you what you can and what you cannot do,
please keep it to your bedroom, and leave me out of it.
This is not a question of information asymmetry; this is a question of cops coming and
beating up people who didn't do anything wrong to anybody else (save for themselves, maybe).
Persecution of peddlers of snake oil does not require any regulation; what they do is called
"fraud", and fraud is not a "victimless crime" like obtaining medicine from officially
unapproved sources.
>This is not a question of information asymmetry; this is a question of cops coming and
>beating up people who didn't do anything wrong to anybody else (save for themselves, maybe).
It is not this simple. If people do things "wrong" to themselves, then the taxpayer has to deal with the hospitalization that follows. If anyone were allowed to use any drug, then more people would take drugs, including ones inappropriate for their conditions. They might get addicted to those drugs, waste all their money, and then force us to pay for their treatment because they become destitute. To put it arrogantly, not everyone is as smart as you (or I) are.
Not only is money a problem, but people taking unknown drugs would get out on the road, and then it would be nearly impossible to determine at which point someone is "intoxicated," perhaps leading to more traffic fatalities, which are already a leading cause of death among young people. Someone who was drunk once slammed into my car at 45 mph from behind while I was stopped at a red light. Are you saying that this person's use of a drug (alcohol) harmed nobody but himself? He injured me, destroyed my family's car, made hassle for the insurance company, placed a burden on the prison system for the year he was in jail, and so on.
You can't say that "progress" will occur more rapidly by removing these restrictions, because the multitude of issues that would be created would divert attention, time, and money away from research into solving problems created by the lack of drug control.
But it is a Q of information assymetry. That is the whole problem. Free trade works via differences in subjective value among participants if I value my camel at X=1 and your horse at X= 1.2 and U vicea versa. We will add .4 in net value by makeing a trade. If I value my 10K at x=1 a extra 2 months with my cancer in remission at= 3 and you value my 10k=1 but you know your medicine is ground advocato leaves worth nothing to me or you but you know that desparate people..... Nothing of value has been added but a immoral man got a bunch of $.
averros define "snake oil" is it medicine whose safety isnt proven or whose efficacy isnt proven if so then that is what the fda regulates. Look man I used to be a libertarian still am really. I just recognize human limitations(that desparation will make people believe things they shouldn't. That private companies will blantently lie in order to sell product. That people will focus on research that tells them what they want to hear to the exclusion of negative research) . So if not the fda then what? Not a rhetorical Q. Really, if you have a better idea im listening.
Courts cases claiming this drug didnt work(fraud?)? well "guilt beyond a reasonable doubt" requires that the plantiff must prove the medicine doesnt work (and you cant prove a negative). So unfortunately there has to be proof that the medicine does work prior to sale. So really unless your a gonna have a judge decide efficacy and safety after the fact(imo a horrible idea...think there is corruption now? hahhahha.)....something like the fda is gonna be around. And it will punish providers of snake oil (unproven medicine).
Doesnt mean it should not be reformed. Or that CYA pols/beauros dont lean WAY too far in favor of safety.
Cops don't beat people up for using unapproved medicines (cept for narcotics O course) (by beat people up I'm assuming you mean figuratively.... initiation of force?). They beat up providers of the unapproved (unproven?) medicine. I think a tendancy to hyperbole sometimes makes people roll their eyes at libertarians/Acists. And you/we have some good ideas for expansion of human freedom and happiness. Should we not at least try to sound less ummmmm.....nuts. IK IK....it is initiation of force technically but to the average person......
Well, I don't think that the main issue here is of whether a medication works or not. If something doesn't work, then snake-oil salesmen will benefit, and the buyers will lose money, but the buyer can always learn from his mistake and make more money.
But if a medication is unsafe, as SAM-e is, then this is a more serious issue. No amount of money can reverse some of the side effects of dangerous medicines. Many people only consider whether they will be paying a lot for what they get in terms of effects. I still see ads outside GNC advertising SAM-e for joint aches and all sorts of other problems, for only $16.99, without any mention of the abundance of negative information against it. Yet, if it were a prescription drug, GNC would be required to list all the side effects, as you hear on TV with those Viagra ads. Nutritional supplements are often more dangerous, yet the regulations on them are less strict. We police prescription drugs where trials have involved thousands of people, and allow people to take supplements where studies are nonexistent or limited.
I don't have a problem with people trying safe and expensive, but ineffective, medicines. But someone still needs to be there to prove safety through controlled trials first.
> If people do things "wrong" to themselves, then the taxpayer has to deal with the hospitalization that follows.
Abolish socialist medicine, too. Then the taxpayers won't have to pay.
You may be surprised to learn that US had a pretty good (by the standards of the time) medical care for the poor in the 19th century - all without any government subsidies and interference. It was the medical lobby of "posh" doctors who were afraid of competing against low-priced colleagues who pushed the "humanitarian" socialization of medical care for the poor - destroying these low-cost clinics in process by regulating them into oblivion. Nowadays no one who didn't spend ten years and hundreds of thousands of dollars on getting a degree from a guild-approved school is allowed to treat common cold.
Soviets (who were somewhat further along the path of "free" medical care) had a nice saying: "You can get yourself treated for free - if you don't care about results".
> averros define "snake oil" is it medicine whose safety isnt proven or whose efficacy isnt proven if so then that is what the fda regulates.
Dictionary is your friend. FDA is in business of protecting interests of big pharma and by eliminating any nascent competition with outrageously expensive requirements. Only total naifs believe that it protects consumers (hint: check the story of Vioxx and other "approved" drugs which turned out to be rather dangerous).
Selling a substance which doesn't cure or is poisonous while claiming it to be a cure is fraud (or even manslaugter - was any pharma executive prosecuted for that? The "official" approval has a function of shielding them from the responsibility.)
Selling the same substance without any claims, or labelled as poison, must be legal. Otherwise pretty much everything can be prohibited on the same grounds as selling of antibiotis without recipe is prohibited. (Mmmm... try staplers, for example. There were a case of someone using an industrial-strength stapler to treat his own headache. We must prohibit sale of staplers without Rx from a quailifed doctor because using them to treat headaches is dangerous.)
Now, any sane person ("sane" as in not braiwashed into believing that Big Government Daddys Won't Let Anything Bad Happen) won't take an unknown substance in just because some clown on the Internet claimed that it works. On the other hand, those who have the skill to use Google and Wikipedia can track down all the relevant information. Which is, in most cases, will be more than a random doctor (who didn't do research on the topic), would know. In the previous example (SAMe being dangerous) the very first place to look - Wikipedia page on SAMe - contains warnings and links to the research papers. Funnily, the same research paper indicates that most "approved" antidepressants have similar side effects.
> plantiff must prove the medicine doesnt work (and you cant prove a negative)
Nonsense. Just a few days ago I was helping my g/f with homework on medical biostatistics - which is all about proving (with given confidence margins) that drugs and treatments do or don't have effect. Look up t-test, Z-test, chi-squared test, and such. All these tests are about establishing likelihood of null hypothesis (i.e. that treatment has no effect).
> Cops don't beat people up for using unapproved medicines
Really? Every law is about cops beating people up. Or threatening to - which in most cases is sufficient to goad people into compliance. If laws didn't have cops with batons and guns to back them up, everybody could've simply ignored them.
> I think a tendancy to hyperbole sometimes makes people roll their eyes at libertarians.
It's telling unpleasant truth to the believers in the Collective is what causes the believers to shut their brains down and roll eyes at the arguments they cannot refute.
You may be surprised to learn that US had a pretty good (by the standards of the time) medical care for the poor in the 19th century - all without any government subsidies and interference. It was the medical lobby of "posh" doctors who were afraid of competing against low-priced colleagues who pushed the "humanitarian" socialization of medical care for the poor - destroying these low-cost clinics in process by regulating them into oblivion. Nowadays no one who didn't spend ten years and hundreds of thousands of dollars on getting a degree from a guild-approved school is allowed to treat common cold.
(((((((((((I agree totally with the abolition of medical licensing.))))))))
Soviets (who were somewhat further along the path of "free" medical care) had a nice saying: "You can get yourself treated for free - if you don't care about results".
(((((((((preaching to choir.)))))))))))))
> averros define "snake oil" is it medicine whose safety isnt proven or whose efficacy isnt proven if so then that is what the fda regulates.
Dictionary is your friend. FDA is in business of protecting interests of big pharma and by eliminating any nascent competition with outrageously expensive requirements. Only total naifs believe that it protects consumers (hint: check the story of Vioxx and other "approved" drugs which turned out to be rather dangerous).
(((((((((((((((((((((The FDA among other things requires evidence of safety and efficacy before a drug can be sold. Studies to provide this are expensive. I dont see a way of getting around that. So the way I see it you either have a agency decide this a priori or a judge/jury post facto. Wiki: "Snake oil is a traditional Chinese medicine used to treat joint pain. However, the most common usage of the phrase is as a derogatory term for compounds offered as medicines which implies that they are fake, fraudulent, quackish, or ineffective questionable or unverifiable or is poisonous."))))))))))))))))
Selling the same substance without any claims, or labelled as poison, must be legal. Otherwise pretty much everything can be prohibited on the same grounds as selling of antibiotis without recipe is prohibited. (Mmmm... try staplers, for example. There were a case of someone using an industrial-strength stapler to treat his own headache. We must prohibit sale of staplers without Rx from a quailifed doctor because using them to treat headaches is dangerous.)
(((((((((in complete agreement. But few people are just going to randomly decide..... hey lets drink chemical X it might cure my arthritis. Someone has to biuld a semi plausible argument for them that it cures their illness. FWIW you can sell random chemicals on the internet NOW AFAIK. You just can't make claims that they treat or prevent disease.))))))))))
Now, any sane person ("sane" as in not braiwashed into believing that Big Government Daddys Won't Let Anything Bad Happen) won't take an unknown substance in just because some clown on the Internet claimed that it works.> On the other hand, those who have the skill to use Google and Wikipedia can track down all the relevant information. Which is, in most cases, will be more than a random doctor (who didn't do research on the topic), would know. In the previous example (SAMe being dangerous) the very first place to look - Wikipedia page on SAMe - contains warnings and links to the research papers. Funnily, the same research paper indicates that most "approved" antidepressants have similar side effects.>>>
((((((((((((Human limitations my friend. You are aware that the average person taking medicine is probably in their 50-60s. They are unfamiliar with new tech. And are in cognitive decline often in the advanced stages. Many people are stupid and I don't mean that judgementally. It's just a fact. If you want dumb people to suffer side efects/lose money as a consequence of their dumbness. Well...that is a whole new issue. That doesnt even account for people who have chronic/terminal illnesses and just are hoping something will work. Hey do a google search for arthritis cures/tinnitus(ear ringing) cures/cancer cures. All those sites...they have a market...thats why they are there. This is not to imply that brian is dumb. He may have made a rational decision and just had bad luck and now regrets his decision. This also is a human limitation. I have a friend who I play poker with who honestly thinks he made a mistake when he doubled on 11 in blackjack and lost. "I knew it. I shoulda just played it safe." He thinks about poker in the same way.))))))))))))))))
> plantiff must prove the medicine doesnt work (and you cant prove a negative)
Nonsense. Just a few days ago I was helping my g/f with homework on medical biostatistics - which is all about proving (with given confidence margins) that drugs and treatments do or don't have effect. Look up t-test, Z-test, chi-squared test, and such. All these tests are about establishing likelihood of null hypothesis (i.e. that treatment has no effect).
(((((((((((You can't prove a negative this is a logical fact. You can prove that a positive is unlikely even very unlikely but that is all. But hey lets go with that......the plantiff can do the multimillion dollar studies to prove he was defrauded. Sound good? )))))))))))))))
> Cops don't beat people up for using unapproved medicines
Really? Every law is about cops beating people up. Or threatening to - which in most cases is sufficient to goad people into compliance. If laws didn't have cops with batons and guns to back them up, everybody could've simply ignored them.
(((((((((((((read my post like I said i used to be a libertarian and still am really in that I believe the highest goal of government should be the expansion of freedom. I get the abstraction here...however...it IS an abstraction. When you write like it is not you sound nuts/disingenuous to people not familiar with the literature. If you want to expand freedom you aren't making a good decision in your choice of words. It sounds like your goal is just to view yourself as above the great unwashed.))))))))))))))))))
> I think a tendancy to hyperbole sometimes makes people roll their eyes at libertarians.
It's telling unpleasant truth to the believers in the Collective is what causes the believers to shut their brains down and roll eyes at the arguments they cannot refute.
(((((((((((((You said cops beat up people taking unapproved medicine. I got your figurative point because I am familiar with libertarian thought. To an average person
that sounds nuts because its just not true with the exception of narcotics as I stated.))))))))))))
((((((BTW
"averros define "snake oil" is it medicine whose safety isnt proven or whose efficacy isnt proven if so then that is what the fda regulates. Look man I used to be a libertarian still am really. I just recognize human limitations(that desparation will make people believe things they shouldn't. That private companies will blantently lie in order to sell product. That people will focus on research that tells them what they want to hear to the exclusion of negative research) . So if not the fda then what? Not a rhetorical Q. Really, if you have a better idea im listening."
Still listening.))))))
averros,
I make the argument about terminal patients because that is the argument that has a chance of persuading people. If you try to argue your broader argument you are going to get the reactions that you see above. The vast majority of people do not think like you do about individual rights and freedom.
The biggest reason for this difference in views about individual rights is probably genetic in origin. People have personality types that cause them to gravitate toward different moral beliefs and different beliefs about personal autonomy.
I used to be a libertarian Republican, but look where that sort of radical conservatism has gotten us today. The country is no longer the great place it was ten years ago. CEOs make hundreds or thousands of times what their workers do (while doing twice as much work), corporate scandals have destroyed retirement accounts, and the Republicans are always looking for the next war. While I believe in my heart that people should be able to do what they want, the reality is that liberalism has brought prosperity and conservatism has not. I don't say that the FDA should restrict drugs because I somehow arrogantly want to dictate to people how they should live; I say it because history clearly shows that the country has been better off in most ways with more government control.
I also think it's ridiculous for anyone here to say that we should stop helping people who experience side effects of drugs they took, whether prescription, supplement, or illegal. If someone walks into a hospital after overdosing on heroin, but can be saved by administering another drug to reverse its effects, you're going to let that person die in the ER because it was his fault that he took the heroin, and so that a few bucks can be saved? We are not savages. Anyone with any sort of ethics who saw that person in front of them would not be able to take the step of refusing treatment.
As a side note, with regards to SAM-e, the drug has been shown to cause manic episodes in a greater percentage of patients than both placebo and other antidepressants. But being ignorant of that fact was not the mistake I made - it was not realizing the seriousness of mania, and believing that it could be cured by simply discontinuing the drug. In reality, mania is perhaps the worst mental state a person can experience, and is far worse than depression.
Averros:
Wiki makes a better friend IMO....."Snake oil is a traditional Chinese medicine used to treat joint pain. However, the most common usage of the phrase is as a derogatory term for compounds offered as medicines which implies that they are fake, fraudulent, quackish, or ineffective. The expression is also applied metaphorically to any product with exaggerated marketing but questionable or unverifiable quality." Now your cute response notwithstanding...how exactly did I misuse the term?
Cops do not beat up people for using using unapproved medicines excepting narcotics. Figuratively maybe literaly NO. When you say junk like this it makes you sound nuts to a average person unfamiliar with libertarian thought. If you want to spread LIB thought you should pick your words more carefully.
Randell: Did you veto my last post? I got a message that the post had been forwarded to the blog owner for approval. This is a very interesting blog and I would post here more except there seems to be some sort of error everytime I try to post.
Well
1. The fda says only drugs and surgery can help sickness
My opionion to that is NOOOOOOOOOOOOOOOOO
2. fda dosent test the medicines enough
People die from certain medacines
3. They destory natural buisness.
Why, That takes away peoples jobs, and if it's a life saving cancer helper
more people will die anyway. Excuse of fda:We dont want snake oil salesmen.
If it was snake oil we have the right to buy it why regulate snake oil when millions of people get scammed online what about focusing on that.
4.America should have a say in what we get in the government. Nothing the fda could do to change my mind. America has a free voice and it needs to be heard.
Also without these natural drugs americas economy is weakend. Think about it we travel to other countrys americas doctors lose money!