Both sides have interesting, if not good, aspects to them. The truth always lies somewhere in the middle. Yes, the FDA is flawed. It’s been proven in the past, when markets were more “free” that some sort of regulation was necessary. The FDA is regulation. Within the constraints of the controls, the markets is free to do whatever it wishes to do.
What if we had things like the parcel delivery industry? We have a government carrier, the basic carrier that offers some gourmet services, and a few private options. They all essentially do the same thing.
Maybe you should look at the reasons why regulations were introduced in the first place - in the UK we had problems with food adulteration.
I don’t share your view of institutional shareholders, it does not tie up with my experience. If they scent a problem they get out, and the biggest problem is reduced returns - which gives professional management a major incentive to cut corners. They are all in it for the short term.
I believe that the market is a big blob of morons, and that there are individuals who are looking for a quick buck, and they would do anything to get it.
I also believe that the government has a natural tendency to interfere, it is simple personal empire building.
The problem is deciding how far to interfere, for example the EC tried to regulate the size and shape of a banana - absurd. Yet Austrian wine manufacturers put glycerol (antifreeze !) in their white wine. Look at the current Vodka problem in Russia.
FDA a bias corrupt mob. Anatabloc actually works and reduces internal inflammation. The FDA forces this product off the market when it is saving millions of people, like me. Without this product I’ll be in a wheelchair again.
The AMA must be running this federal unregulated agency.
To solve a crime follow the money.
You can take those drugs in countries that have approved them or are you talking about drugs that haven’t been approved anywhere? Can you just imagine how much money someone can make off a rich guy dying of cancer?
Who is keeping track of the heart attacks in the general population?
Those lawsuits represent lives and health. So its really profits::lives (with a price tag only if the death is detected and attributable to your drug and the price you pay is limited by how much you have in assets, its not like we can take dividends back from shareholders).
A lot of bureaucracies work this way. They are overly conservative and primarily concerned with avoiding criticism. This argument against the FDA is applicable to just about every regulatory body in the government.
DA, Opus1 hasn’t posted in over a year. Abolishing the FDA because the approval process is too slow seems insane, even for libertarians (well, they generally seem insane to me), and I notice one of the idea’s supporters is Sam Stone, a known Canadian who benefits from the studies of of both the FDA and Health Canada, while getting treated at socialized medicine prices.
20 years in pharmaceutical development, clinical trial management, and pharmaceutical manufacturing have taught me one thing:
The FDA is absolutely, positively necessary.
The complexity of these things are staggering, and multi factor analyses require lots of data. Not only would we not do it if we didn’t have to, we KNOW what studies to avoid lest we risk discovering something we don’t want to know. And if we didn’t do it, no Consumer Reports or UL would be able to, because all that data costs shitloads to generate. FURTHERMORE, they couldn’t do it even if they had the money. Why? We wouldn’t give them the product, which if not OTC would only be available from us. But remember, we aren’t stupid. So all we have to do to prevent the controlled study that would actually elucidate safety and efficacy is come up with some BS reason why we won’t make the product available.
And if you don’t have a serious background in the right subjects, and statistics, you are not going to be qualified to assess the data on your own.
That’s to say nothing of the enforcement role the FDA plays with respect to manufacturing. Remember, this is a space where tiny errors can turn medicine into poison. Without the FDA performing inspections, even good drugs will become unsafe. And, with the complexities involved, lawsuits will never serve as adequate enforcement mechanisms, because the lack of data (see above) will make it impossible to convince a jury that the harm was caused by the product.
I realize that we love cites in this forum, but please trust me- 20 years across several pharma R&D/Clinical organizations, from startup to massive- I have seen how important the phrase “The agency will never go for that” is to keeping things honest.
The FDA doesn’t stop the supplement market because of legislation that specifically bars them from doing so. If they were legally allowed to, supplements would largely be out of business for having exactly zero science behind their purposely generic claims.
If people wanted effective medicines, they wouldn’t be using herbal supplements (which in many cases are primarily rice and/or include ingredients that are not listed), holistic medicines (water), or other things along those lines, yet it’s a multi-billion dollar industry.
“Steve Jobs Regretted Wasting Time on Alternative Medicine”. Oh, look, one of the richest Americans of his time wasted time by putting off cancer treatment in favor of alternative medicines that had absolutely no science behind them. Quackery over medicine! This just underscores how much people want to believe in magic rather than science, so selling them magic (supplements) is very effective at making people money but not very effective at improving health outcomes.
I consult my mechanic when buying a used car (by having him give it a top-to-bottom check for issues) and look up repair records when buying new or used. I’m not sure why that matters for this argument.
Yes, it happens all the time. People self-diagnose and go to the supplement aisle rather than seeing a doctor, or they treat symptoms without bothering to get the cause diagnosed and treated. CDC statistics estimate that 27.8% of diabetics are undiagnosed. It is a disease that makes it very clear through symptoms that something is wrong yet we have millions of people that don’t care enough to get diagnosed, don’t have the access to doctors, self-diagnose and treat, or for whatever other reasons might be shopping in the supplement aisle.
It’s hard to find numbers, but one big market for supplement users also appears to be those with depression. St. John’s wort and other herbal supplements are commonly marketed for mood. Large numbers of people certainly self-treat with unproven supplements at the least and probably even self-diagnose in many cases.
I’d kinda like to see tiers of drug approval, i.e.:
Level One: promising but unverified - take this if known alternative are unsuitable but it’s at your own risk.
Level Two: Used to be a Level One, but it’s been a few years of broad usage and it doesn’t seem to be killing too many people.
Level Three: Used to be a Level Two, but it’s been a few years of broad usage and it seems to actually be beneficial. The equivalent of what is now “FDA approved”.
If I had cancer and established chemo drugs were ineffective, I’d roll the dice on a Level Two, maybe a One. Just spitballing, of course.
In this case, the money was followed - all the way to former Virginia governor Bob McDonnell (who is reported to have gotten some very nice [del]payoffs[/del] gifts from the CEO of STSI, the supplement company that was selling Anatabloc.
*"Before the prosecution rested in the public corruption trial of former Virginia Governor Bob McDonnell and his former NFL Cheerleader wife Maureen last week, the focus shifted to the patent nostrum sold by Jonnie Williams, who is said to have given the couple high-priced gifts in return for promoting his product, a snake oil named Anatabloc. The active ingredient in Anatabloc is Anatabine, an alkaloid derived from tobacco.
Anatabloc was said to “reduce inflammation and support a healthy metabolism” but was marketed as a “dietary supplement” to avoid those pesky clinical trials required of drugs. That didn’t keep the firm from claiming that the stuff can mitigate Alzheimer’s disease, multiple sclerosis, thyroiditis and traumatic brain injuries. You know, like a drug. Finally, the FDA caught them at it and issued a stern letter.
But the McDonnell trial has increased scrutiny on and skepticism of Anatabloc, so the manufacturer has finally stopped selling it."*
For those convinced Anatabloc is a panacea, don’t worry - someone will be selling and promoting it or similar snake oil before too long. If potential profits are attractive and all you have to worry about is a “stern letter” from the FDA, what’s to stop you?
The FDA is (at least when it comes to supplement quackery) a largely toothless dragon.
I realize this is a zombie and Opus doesn’t post here any more, but…
…Areyou[serious](THE ENTIRE SUPPLEMENTS MARKET)? When it comes to biology and health - extremely complex, multifaceted decisions which are hard to understand - people behave like blithering idiots! I still can’t get my father to understand that homeopathy doesn’t work, and homeopathy is the most transparently bullshit non-medicine in the history of medical science. Put your quackery in a less transparent package, like Burzynski does, and you stand a good chance of fooling a lot of otherwise very smart people. See also: the entire freakin’ supplements market. Or how about vaccines? The process of “let it hit the market, then let people sue if they’re harmed” almost drove vaccines against Diptheria, Pertussis, and Tetanus off the market, despite the fact that there wasn’t even remotely good evidence supporting it. If we hadn’t implemented the VICP, we would have had the same thing happen in 1992 with MMR. Medicine is really, really hard.
I think it’s also important to point out that despite Vioxx coming out as dangerous, and the company getting their britches sued off, they still made out like kings! They lost money on the lawsuit, but nowhere near as much as the profit margin was for their drug.
I also love people comparing drugs to computer monitors. Yeah, sure, you can’t tell if a monitor will blow up in your face when it’s on the shelf in Best Buy, but when it does blow up in your face, you can immediately tell “Ah, well, I know what did that and exactly who to sue!”. But when your son is given the MMR vaccine and shortly thereafter develops autism, how easy is it to draw the wrong conclusion? When you take Vioxx and then shortly thereafter get a heart attack, how easy is it to determine that it was the Vioxx that caused it?
Look, the FDA didn’t just come into being as part of a government plot to control more of the nation. It was a response to a very real, very serious problem - drugs were being pushed and we had no way of telling if they worked or not. The consequences are often quite nasty. We can look back at all the times the FDA held back drugs that were still in testing which turned out to be life-savers and prognosticate over how that was harmful. What we cannot do is look over all the drugs the FDA banned and say “what would happen if those hit the market?” Rather, we have to look at what happens in medical industries not regulated by the FDA and see what happens. For example, alternative healing - 99.999% of it is total bullshit. Or supplements - again, vast swathes of it are completely unhelpful, often even harmful. Indeed, is it not a clear failure of the free market that homeopathy continues to be a popular medication? It doesn’t work! It CANNOT work! And yet it is still valuable, despite selling it as medicine being tantamount to fraud!
Is there any country which doesn’t have an organization like the FDA? If so, how are things there? If not, what does that say about the essential nature of an organization like this? Despite the best fantasies of libertarians, the average consumer is not scientifically literate when it comes to medicine. The average consumer is at best trusting in what the FDA and CDC has to say with little understanding of how the scientific review process works, and at worst likely to believe anecdotes and extremely bad research papers. As such, organizations like the FDA are entirely necessary.
Do they sometimes restrict access to drugs that go on to save lives? Yes. But here’s something that we *need *to keep in mind when talking about that - for all intents and purposes, until something has passed clinical trials, we don’t know if it works! You know, that’s sort of the whole point. To scientifically evaluate the procedure to see if it works in the first place. To see if it is safe and better than the current alternatives (yes, “no care” is considered an alternative). Opus1 pointed out that the first beta blockers were delayed from the market for 3 years. Yeah, in hindsight, that’s pretty damning. But at the time, were the effects well-known and well-understood? Did we know they worked before the clinical trials? I didn’t follow it precisely, so I dunno. Maybe we did for some reason. But that’s part of the reason the FDA has its “fast-track” program, isn’t it?
The FDA is necessary, valuable, and tenable. The idea that we could get rid of it in this day and age, when we have seen the harm done by sham medical industries which the FDA explicitly cannot regulate, is asinine. Necro or not, I am perfectly happy to continue this conversation.
Interesting timing on this thread revival–I’ve just been thinking about this very issue.
Two thoughts–
Even though I’m a hard-core conservative with libertarian tendencies, I freely admit that the FDA has done some good. HOWEVER–if we’re going to keep it, I really, really wish that the rules on untested treatments would be changed to allow for compassionate/last-ditch efforts. If someone has a terminal prognosis, the possibility of major negative side effects from a promising but untested treatment can hardly be any worse of an outcome.
I think that we could get the same consumer protection that the FDA provides by abolishing it and putting the responsibility on the people who run the drug companies. If a company knows that a new drug has bad side effects, but markets it anyway, then the CEO, all the board members, the person in charge of research, etc., not only go to prison for a very long time, but they also forfeit all of their personal property. In addition, the company itself gets fined 10 times the gross sales of the drug.
It may be a zombie, but it seems like the opinion that we can do away with the FDA is more politically tenable today than it was almost a decade ago, so…
They already do this. Compassionate use exceptions are not uncommon; they don’t often do much, but they exist. I don’t know why you’d think they don’t. The people at the FDA aren’t stupid, you know.
Oh, sure, this would be a neat incentive, but like the tort issue that Opus1 brought up, it has one significant flaw: it does nothing to prevent the fraud and injury. It strongly incentivizes not doing it, but without the FDA review process, how would we even know if it was the case? I dunno, I just don’t like solutions that see a problem after the fact and say, “HEY! STOP THAT!” when we could have solutions that see a problem before it happens and nip it in the bud.
