If not the FDA, then what?

[Sarrisan]

I've been arguing with a friend about the benefits of free markets. He's an Ayn Rand fan, though not an Objectivist, and so is receptive to the general ideas of free markets. He accepts the moral basis - i.e., that people have a right to their property, etc - but has the common idea that it's simply too inefficient or slow.

Specifically, our argument has been about the FDA and the role it plays. He thinks that it, if nothing else, it is crucial, that there is simply no other way to keep bad drugs off the market - that, essentially, if we get rid of the FDA, then the market would be inundated with shoddy products made by corporations who cut corners to save money. I pointed out that no good corporation does such things - that true profit comes from skilled long-range planning, which he eventually agreed to. But he is still convinced that the FDA is a necessary evil, and the only bad things that it has resulted in recently are a product of having insufficient federal funds. I also mentioned that, in general, bad products never stay on the market for long, and that in a market free of regulation such things as an FDA really would not be needed. He rebutted by saying that, even if that were true, it would still be too slow a process to keep thousands of people from potential sickness and death, and he also pointed out that there are a great many BS products out there that people believe in daily (For instance, Homeopathy).

It is here that my arguments floundered.

So my question is, what would you say are the problems with both mine and my friend's arguments, and what would be a good way to convince him that having the FDA is a bad thing?

(It also occurs to me that I probably should not be arguing such things with such limited knowledge... but now that I have started, I feel bad about simply giving up - essentially agreeing that perhaps some regulation is a good thing.)

Edited September 4, 2008 by Sarrisan

[volco]

Well the market is not a guinea piggery, that's why pharmaceutical corporations use many mice and millions of dollars before launching a product - in addition to complying with FDA regulations.

For the argument that people could get intoxicated by "trying" new drugs from the counter before they are proven fowl, you can reply that just as many or more people die each year for not being legally permitted to purchase not yet approved drugs.

But the key issue, is that it's not the FDA or the SENASA in my case, that ought to decide what medicines you can pick, it is yourself with the assistance of your doctor.

It's the same case for over the counter vs regulated drugs or even illegal drugs: a bureaucrat or 1000 government medical doctors, simply can't decide what's better for you better than yourself (with a much professional assistance as needed/wanted).

Back to the utilitarian argument: Probably if pharm companies didn't have to put up with governments regulations, they'd have more time and money to test and sellect their products by themselves. No company wants to be known for deliberately launching a toxic "medicine".

Now that I think about it, a government has as much right to control what you read, than what you ingest. The FDA would thus be the materialistic version of a Censorship agency or Inquisition.

Edited September 4, 2008 by volco

[D'kian]

He rebutted by saying that, even if that were true, it would still be too slow a process to keep thousands of people from potential sickness and death, and he also pointed out that there are a great many BS products out there that people believe in daily (For instance, Homeopathy).

That's your argument right there. It's true there are millions of people who believe worthless products will improve their health, and none of these products are regulated by the FDA. IN other words, where are the hungry, greedy corporations who make a profit out of killing people with shoddy drugs? Why aren't they selling herbal extracts, electroacupuncture kits, etc etc, out on late night TV infomercials?

So my question is, what would you say are the problems with both mine and my friend's arguments, and what would be a good way to convince him that having the FDA is a bad thing?

How many people die or fail to get relief while a drug worms its way through the FDA's maze? Specifically terminal patients who will die regardless of what their doctors can do, but who have even a slim chance with a new drug --which won't be available for two to five years.

This isn't hypothetical. When AZT was still in clinical trials, AIDS was a death sentence. Naturally thousands fo AIDS patients wanted it, even if it wasn't safe or had nasty side effects (how much nastier than death can a side effect get?)

[gags]

He rebutted by saying that, even if that were true, it would still be too slow a process to keep thousands of people from potential sickness and death, and he also pointed out that there are a great many BS products out there that people believe in daily (For instance, Homeopathy).

Selling a drug that doesn't work is fraud. Selling a drug that kills someone is a tort/act of force against an individual. Both of these are illegal in a rational society and our legal system allows for the offending companies and the executives that run them to be punished. This can be accomplished without the massive bureaucracy that is the current FDA.

D'kian also makes a good point about the thousands upon thousands of people who die waiting for drugs to be approved by the snail-like FDA. That is an attrocity in my opinion.

[exaltron]

In addition to all the arguments made above, I would add that the FDA butchering a valuable service which in a free market would be:

1. voluntary in its enforcement

2. voluntary in its funding (most likely a private safety agency would be funded by doctors and/or consumers)

3. massively more efficient in providing unbiased (and uninfluenced by political considerations) information about drugs and their safety.

There is much more to this, a lot of which is covered in OO member Stellavision on her blog ReasonPharm.

[Chops]

Here's another thread about this debate.

[Sarrisan]

Thanks everyone for the replies. I think I'll try linking him back here next time I get in touch with him.

@ Chops

Dang, I did some searching before I posted but I couldn't find any other threads on the subject. Thanks for the link.

[Chops]

Dang, I did some searching before I posted but I couldn't find any other threads on the subject. Thanks for the link.

Hey, no sweat. Searching for "FDA" isn't going to work, as I think the search doesn't index 3-letter words (If MySQL fulltext indexes, then the admins could modify the index to support 3-letter or 2-letter queries)

[Qwertz]

Selling a drug that doesn't work is fraud.

This is a minor thing, but selling a drug that doesn't work isn't fraud. Fraud is a knowing misrepresentation of material fact, reasonably relied upon by another to his detriment. Both civil and criminal fraud require a knowing misrepresentation of fact, and it is that wrongful misrepresentation that constitutes fraud, not the sale itself (though the sale is often offered as evidence of detriment). If selling a drug that doesn't work were fraud, no one would sell drugs, because no drug works for all patients.

~Q

[Maarten]

This is a minor thing, but selling a drug that doesn't work isn't fraud. Fraud is a knowing misrepresentation of material fact, reasonably relied upon by another to his detriment. Both civil and criminal fraud require a knowing misrepresentation of fact, and it is that wrongful misrepresentation that constitutes fraud, not the sale itself (though the sale is often offered as evidence of detriment). If selling a drug that doesn't work were fraud, no one would sell drugs, because no drug works for all patients.

~Q

I am taking a course in biopharma law right now, and my professor mentioned that there is a concept that's something like "insufficient testing". It applies pretty much to any product you might buy, where a manufacturer is liable if the plaintiff can prove that the safety testing done for the product wasn't sufficient.

Now, I am not sure if this concept is at all valid. It certainly seems to set a (potentially) unreasonable, omniscient standard. But either way, as it currently stands, it would be a potential liability if something happened that could have been discovered with further testing (I guess you try and prove that they were (criminally) negligent in their QA procedures?).

On a brighter note, apparently there's a bill currently in the works that would immunize pharmaceutical companies for liability of any approved uses of their drugs. I think that by itself would be a step forward, because it makes it somewhat less insane to produce drugs in today's market with all the liability suits going on. Sure, ideally the FDA shouldn't exist, but it is a good step for some temporary relief for these companies, in my opinion.

[Myself]

Here's a thread I started a few years ago.

[gags]

This is a minor thing, but selling a drug that doesn't work isn't fraud. Fraud is a knowing misrepresentation of material fact, reasonably relied upon by another to his detriment. Both civil and criminal fraud require a knowing misrepresentation of fact, and it is that wrongful misrepresentation that constitutes fraud, not the sale itself (though the sale is often offered as evidence of detriment). If selling a drug that doesn't work were fraud, no one would sell drugs, because no drug works for all patients.

~Q

Assume someone represents that the sugar pills they are selling cure cancer. What is the legal term for that?

If a drug manufacturer provided information to the consumer that testing indicates the product is effective in 30% of the cases, wouldn't that help to reduce their potential for being sued? Of course, as you say, no drug works for everyone.

[brian0918]

On a brighter note, apparently there's a bill currently in the works that would immunize pharmaceutical companies for liability of any approved uses of their drugs.

That sounds pretty ridiculous. So, any company that's big and corrupt enough to buy FDA approval (NutraSweet/Aspartame comes to mind), now gets the benefit of being safe from prosecution? It's a perfect system for corruption to thrive!

How can you believe this is a good step without ignoring the high likelihood of corruption? Companies aren't by definition good and moral. The FDA provides a means for corruption, and many companies take advantage of that, just as companies buy politicians who pass selective taxes, tax breaks, etc. Now the government is trying to close the loop of corruption (I wonder who bought this legislation) and protect it from destruction.

Edited September 5, 2008 by brian0918

[Maarten]

That sounds pretty ridiculous. So, any company that's big and corrupt enough to buy FDA approval (NutraSweet/Aspartame comes to mind), now gets the benefit of being safe from prosecution? It's a perfect system for corruption to thrive!

How can you believe this is a good step without ignoring the high likelihood of corruption? Companies aren't by definition good and moral. The FDA provides a means for corruption, and many companies take advantage of that, just as companies buy politicians who pass selective taxes, tax breaks, etc. Now the government is trying to close the loop of corruption (I wonder who bought this legislation) and protect it from destruction.

I don't think that will be the case. Currently, there is a very large deterrent for pharmaceutical companies to develop new drugs, at least in part because of the risks they're taking with them (possibly) being withdrawn before they become possible, and with the company then being sued for a lot of money. Overall, I think it would help a lot more than it would hurt the current state of affairs.

In my book, pretty much anything that makes it easier for companies to develop new drugs is a good thing. Sure, it may be abused sometimes, but the VAST majority of companies aren't out there to scam you and kill your children.

[brian0918]

In my book, pretty much anything that makes it easier for companies to develop new drugs is a good thing.

As I said, this is founded on the false premise that companies are by definition good. What you ignore is that our economy is nowhere near a free market. You're saying that we should fix a government restriction by adding another government restriction - ie, if the government says something is alright, and people believe the government, those people have no hope of recourse if the claims made by those propped up by the government turn out to be false or unsupported.

Sure, it may be abused sometimes, but the VAST majority of companies aren't out there to scam you and kill your children.

Any time they influence the government to get legislation passed in their favor, corruption occurs, no matter how dangerous or safe the drug is.

I can see a bad scenario that plays out much like the subprime mortgage crisis. A pharmaceutical company headed by a politician (e.g. Donald Rumsfeld who headed Searle when Reagan helped them breeze NutraSweet through the FDA), buys an FDA approval for a cheap drug with a purpose that would be popular (e.g. zero-calorie sweetener). It's approved for all uses, and companies rush to add it to their products (e.g. every "diet" beverage). People invest in those company, and stocks are traded globally. World markets come to depend, in one way or another, knowingly or not, on this drug.

Then the drug is found to increase the likelihood of cancer by a large fraction. People stop buying the products. Those companies belly-flop overnight. The people who invested in those companies lose big, and the markets crumble in response. Governments rush to nationalize failing banks, etc.

Edited September 5, 2008 by brian0918

[Maarten]

But the thing is, right now it's the FDA that approves drugs, and therefore makes the final decision on whether or not a drug is safe. So why should the company in question be fully responsible for things they couldn't have foreseen? The restrictions placed upon them by the FDA are already such a huge burden, and I think that this ruling basically places the responsibility solely with the FDA. I think that on the balance that is a good thing, because maybe then people will realize that if something bad happens, it is the FDA's failing, and not the "free" market's or the company's.

I didn't say companies were by definition good, just that the vast majority of them are. It most certainly isn't a perfect solution, or even a good one. I agree that these restrictions shouldn't exist. But I think it is still an improvement over the status quo, and as such, might lead to a beneficial effect, overall, on our well-being. Anything that reduces the rather insane risks associated with developing drugs will lead to more of them entering the market. That is a simple application of economics, because investors will be more likely to invest in these drugs. And I believe that that is a good thing. Can it be abused? Sure it can, and it probably will be. But I am quite certain that in cases of gross negligence that cause harm, this ruling won't hold water, that there would be some kind of recourse available (even if it's just suing the FDA for failing to do its job).

It just annoys me that everyone is expecting omniscience from companies when they develop drugs. Many extremely rare side effects are almost impossible to test for, and it's unreasonable to hold them to an impossible standard. You should have known is not a valid argument, unless you can prove that they went out of their way to hide the evidence or something.

p.s. Aspartame isn't a drug, as far as I know. It is a food additive, which is also regulated by the FDA. I'm just saying that because I think the regulatory process for both of those things is vastly different, and not really comparable. I am not familiar with anyone using aspartame to treat disease, for example. So I am unsure as to how much this example really holds in this discussion about (medicinal) drugs.

Edited September 5, 2008 by Maarten

[brian0918]

I think that on the balance that is a good thing, because maybe then people will realize that if something bad happens, it is the FDA's failing, and not the "free" market's or the company's.

That's the only benefit I can see of this, that it will bring down the FDA all the sooner. But the FDA is part of the government and of course gets a huge leeway in any court cases. It's like the land development family who were sent to prison for doing construction in a pine forest that the EPA labeled a "wetland". In the trial, they were not even permitted by the court to argue whether or not the EPA labeling was correct, which was the entire crux of the thing. So sure, people will more quickly see that the FDA is a joke, but what will become of that?

I'm always leery of adding more government restriction on top of government restriction. It's like saying that a tax break for oil companies is a good thing. It's still market manipulation. Selective taxation and tax breaks are always bad. Only if the government universally reduces or removes taxes can we argue that a good thing might have occurred.

But I am quite certain that in cases of gross negligence that cause harm, this ruling won't hold water, that there would be some kind of recourse available (even if it's just suing the FDA for failing to do its job).

And the corrupt people at the FDA will be fired and replaced with more corrupt people, and the cycle will continue.

You should have known is not a valid argument, unless you can prove that they went out of their way to hide the evidence or something.

I'm not saying they need to know everything. But they have to do some testing in order to even know if there are true benefits for the product (in order to even market the product to the public as having some beneficial effect) - otherwise it's fraud to claim that the product has some benefit. Those tests may reveal bad side effects, and if those side effects aren't revealed to the public - more fraud.

p.s. Aspartame isn't a drug, as far as I know. It is a food additive...

I'm not entirely familiar with the mechanisms, but aspartame (like any sweetener) tells your brain that you've ingested a sugar and your brain responds by releasing insulin. But there's no sugar to process. If your liver is likewise low on glycogen, you increase your risk of insulin shock, which can lead to seizures. For comparison, diabetics can have seizures if they inject insulin but forget to also eat something in order to raise their blood sugar level.

Whether or not you want to call this a "drug" is not important - the impact on the body is pretty clear.

Edited September 5, 2008 by brian0918

[D'kian]

It just annoys me that everyone is expecting omniscience from companies when they develop drugs. Many extremely rare side effects are almost impossible to test for, and it's unreasonable to hold them to an impossible standard. You should have known is not a valid argument, unless you can prove that they went out of their way to hide the evidence or something.

It's worse than that. Some drugs are perfectly safe when taken alone, but will cause side effects when combined with others. Of course drug companies will test combinations as far as possible, but you can't test every drug against every other drug, much less agasinst every possible combination of any number of drugs (that number is so large it might as well be infinite).

p.s. Aspartame isn't a drug, as far as I know. It is a food additive, which is also regulated by the FDA. I'm just saying that because I think the regulatory process for both of those things is vastly different, and not really comparable. I am not familiar with anyone using aspartame to treat disease, for example. So I am unsure as to how much this example really holds in this discussion about (medicinal) drugs.

There is no medicinal use for it. It may be helpful for diabetics, for example, but it's not crucial.

On the other hand some dietary suplements are used to treat disease. Usually in a secondary capacity (for example people with anemia take iron suplements), but a very important one. Some people can't process vitamins from food, for example, and need to take suplements. Albinos can't make enough vitamin D by exposure to sunlight and likewise need suplements. Yet suplements are laxly regulated or unregulated entirely.

BTW some suplements come with processed foods and we're usually not even aware of them. For example, milk is fortified with vitamin D and calcium, and most people get their fill of iodine from iodized table salt.

[Maarten]

I'm not saying they need to know everything. But they have to do some testing in order to even know if there are true benefits for the product (in order to even market the product to the public as having some beneficial effect) - otherwise it's fraud to claim that the product has some benefit. Those tests may reveal bad side effects, and if those side effects aren't revealed to the public - more fraud.

I'm not sure about that. Granted, if they claim something to be true when it isn't and they have evidence contradicting it, that's fraud. But simply knowing something and not saying anything about it is not necessarily fraud. Otherwise you end up on a slippery slope where companies have to disclose any kind of information that may pertain to the health of others, and I do not think it is right to force them to do that.

Again, if they claim that X doesn't happen, when it really does, that would be fraud.

Oh, something that is reason for good cheer: Apparently the FDA is extremely overextended as it is, which is a very good sign, because it makes it impossible for them to be as strict as they'd like to be. I think that might keep the market a lot free-er than it otherwise would be...

Edited September 6, 2008 by Maarten