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Wouldn't it be nice if there were more government warnings and less restrictions / regulations? Imagine if the FDA, instead of blocking new drugs for 10 years
by clarkmoody 10y ago
Wouldn't it be nice if there were more government warnings and less restrictions / regulations?
Imagine if the FDA, instead of blocking new drugs for 10 years and $1B, it simply withheld its endorsement until satisfied by the clinical trials. Consumers could then take the government's recommendations into consideration when making a decision and drugs could get to market much faster.
The history of medical reversals -- and in this case, nutrition reversal -- shows that the government isn't magic.
A whole raft of restrictions could be converted to warnings and recommendations, freeing up industry to innovate and consumers to take a little more responsibility for themselves.
Imagine the history of the past few decades if the state had outlawed any foods with more than X% cholesterol. Or trans-fats. Or any of the other food fads over that time. It would have been terrible, especially now that the recommendation is reversed. The whole time, consumers were allowed to factor government warnings into their decisions, but food producers weren't breaking the law by selling foods with (X+1)% cholesterol.
- greglindahl 10y agoDrug approvals are currently much better than nutrition studies. Your suggestion of allowing not-known-to-work "medicine" to be sold would return us to the era of patent medicines, which killed a lot of people. You can look at the supplements market to see people dying from a similar policy right now.
- BurningFrog 10y agoLike anything else, you have to look at both costs and benefits of the alternatives. The current extremely tough FDA approval process has the benefit you mention: Fewer people are injured by unsafe drugs. But it also has a big (but harder to observe) cost: If disease X kills 1000 people/year, then each year a cure is delayed kills 1000 people. The main argument against the current system is that it weighs the deaths of people in the first category vastly more than those in the second. How many people the FDA process kills this way is hard to calculate, and you can find wildly different estimates. But most discussion assumes it doesn't even exist...
- greglindahl 10y agoThe FDA has stricter rules now about drugs because of previous problems where some approved drugs killed people, and others were ineffective, and some were both. So we already have experience with some alternatives to the current scheme.
- generj 10y agoThe problem is that we also don't know how many people might be killed by an unsafe drug. It's impossible to know in advance what could fail with a drug - hence the testing. We have no concept of the upper bound of possible deaths. If a major drug is released without enough drug trials and widely prescribed we could lose thousands. See Voixx for an example. Almost 40,000 people died [0]. This was with a comprehensive drug trial under the FDA process. We would have many more incidents like this if not for drug trials required by regulatory agencies. On the other hand national statistics on deaths caused by various diseases have been compiled for decades. We can know with certainty the upper bound of people killed per year (which in your example isn't 1000 but some fraction of that - no drug is 100% effective). Also, many drugs don't prevent deaths but merely comfort the patient or remove some symptoms. Many drugs have alternates which could be taken. Many drugs have an upper bound of deaths prevented of 0. Why should we risk any lives for a drug which cannot save any additional lives? In general humans prefer taking a known risk with known odds rather than an unknown risk with unknown odds. If an informed consumer wants to make a different choice than the FDA, nobody is stopping them from traveling to a country where the drug is already available. [0] http://www.npr.org/templates/story/story.php?storyId=5470430 http://www.npr.org/templates/story/story.php?storyId=5470430
- Alex3917 10y ago> Imagine if the FDA, instead of blocking new drugs for 10 years and $1B, it simply withheld its endorsement until satisfied by the clinical trials. The way you'd like the FDA to work is literally the way it already works. You're allowed to buy basically any drug you want unless it's scheduled by the DEA. Companies just aren't allowed to market them as being effective for a specific disease without passing clinical trials.
- Laforet 10y agoCan doctors legally prescribe them without FDA approval? There are many niche drugs currently unavailable for therapeutic use in the USA because no current manufacturers hold an FDA certification.
- greglindahl 10y agoDrugs have to be approved by the FDA for some condition to be sold at all in the US. Once available, they can be prescribed on and off label, as long as the manufacturer doesn't encourage any kind of off-label use.
- mkautzm 10y agoThe science behind nutrition health is extremely complicated and expecting it to remain constant represent a total misunderstanding of how nutrition research is done and how results are determined. > The history of medical reversals -- and in this case, nutrition reversal -- shows that the government isn't magic. What it shows is that nutrition science is hardly 'solved' and you'd be hard pressed to find a researcher in the field suggest otherwise. > A whole raft of restrictions could be converted to warnings and recommendations, freeing up industry to innovate and consumers to take a little more responsibility for themselves. The problem with this is that the average consumer is both A) dumb, and B) doesn't know what they need. Alternative medicine skirts very cleanly around FDA regulation by not making any medical claims on it's product. They still market their product as a solution for various diseases and conditions, but they never make a formal claim. It's a $30,000,000,000 industry of people buying stuff that does nothing, or worse yet, can cause potential harm. To suggest their is no value in regulation of the drug markets is to suggest that people's health has no value. The defense of, 'well, people are responsible for their own decisions' doesn't hold any water when we know that the direct consequences of that mentality can be measured in literally tens of billions of dollars.
- WillPostForFood 10y agoThat is why people have been so slow to mobilize around climate change predictions.
- mustacheemperor 10y agoOnly through people's incorrect interpretation of reality. >nutrition science is hardly 'solved' and you'd be hard pressed to find a researcher in the field suggest otherwise. You'd be hard pressed to find a climate scientist not in agreement with the consensus on climate change, at least one that isn't already promoting book deals on Fox.
- WillPostForFood 10y agoyup, the science is "agreed on." Disagree and lose your job/funding. That's how to build climate consensus.
- throwaway2016a 10y ago> Imagine if the FDA, instead of blocking new drugs for 10 years and $1B, it simply withheld its endorsement until satisfied by the clinical trials. Consumers could then take the government's recommendations into consideration when making a decision and drugs could get to market much faster. I'd go one step further. Give the FDA competition. Have private companies (similar to UL for electronics) that can endorse and test drugs.
- Scirra_Tom 10y agoPrivate companies have profit incentives. If a horrible substance comes to market they can be paid off to endorse it. You can argue that no rational company that cares about its reputation would do such a thing, but history has shown time and time again - yes corporations do waive all consideration for public safety in lieu for money. The government is the perfect institution to endorse safety of substances/drugs/whatever for use by it's citizens. That doesn't mean they are perfect though, but I would trust them a thousand times more than a corporation. It's extremely wreckless to apply free market economic theories to things like this. In the real world, consumers and businesses are irrational.
- ams6110 10y agoBecause government officials are never paid off?
- smallnamespace 10y agoNo, because government officials are paid off much less often because it's harder. Outright bribery in the US is rare, difficult, and if caught, will land you in federal prison for a long time. Remember Blagojevich? Government officials are under much more scrutiny than a private sector executive. There are independent investigators general that have broad latitude to look for malfeasance. The FOIA exists to bring government records to light; there is no equivalent in the private sector. Heck, we spent ~$80mm investigating Clinton over the Lewinsky affair. The government isn't perfect, but it's a damn sight more transparent and directly accountable to the public than private companies are.
- Scirra_Tom 10y ago> Wouldn't it be nice if there were more government warnings and less restrictions / regulations? ... A whole raft of restrictions could be converted to warnings and recommendations, freeing up industry to innovate No, not without specific examples of how government regulations are a burden on innovation. Whenever people argue this point in industry X it always seems difficult to come up with concrete examples. > and consumers to take a little more responsibility for themselves. Secondly, again no. Consumers are not rational machines who make rational decisions based on time spent researching what they are consuming.
- WillPostForFood 10y agoI was just reading the new laws enacted for 2017 in California, which included a ban on powdered alcohol, even though it has never been for sale in the state. That's one concrete recent concrete example where a warning would have been a nice alternative.
- mstodd 10y agoI think it would be nice to not have the government involved in my food decisions in any way. I'm going to let people I've never met tell me what I should eat instead of looking at people I share genetics with? I'm also not going to listen to people who subsidize food producers as if they're impartial
- badsock 10y agoJust as an example: 9% of the cases of Idiosyncratic Drug-induced Liver Injury is self-harm caused by people taking non-regulated dietary supplements: https://www.ncbi.nlm.nih.gov/pubmed/18955056 https://www.ncbi.nlm.nih.gov/pubmed/18955056 You have a theory that the average person will wisely assume the responsibility to vet the health effects of what they consume, but empirical reality disagrees with your theory. Right now people are injuring themselves with products at the margin of regulation. There's a societal cost for lots of people injuring themselves, and offloading the responsibility of researching safety to the average consumer will cause fear and superstition, limiting people's willingness to try new products, and I would argue that that reduces innovation. Regulation in this area has been a net societal benefit.
- azinman2 10y agoDon't forget that marketing budgets for pharmaceuticals are also huge. The average person has no chance. The constant bombardment already means people go to their doctor asking for Rx by name even without understanding the medical need or if they're right for it. Now remove regulation... the warnings basically just blur into the background. Already we get so many warnings on prescriptions that they just turn into nothing because people become so habituated to them. It's identical to the paradox that is windows/browser security -- the more you warn, the more people just click through and ignore.
- RangerScience 10y agoHmm. Could you then disallow any advertising of drug while you're still without FDA endorsement? Like how you're not allowed to advertise cigarettes. I suspect this line of thinking just leads to too many problems, however.
- frisco 10y agoNot too many problems, that's in general exactly how it works today. FDA approvals are generally marketing approvals: what you're allowed to advertise your drug for and to who. Physicians can do more or less whatever they want in terms of prescribing things. (Drugs which aren't approved for marketing for anything yet are a little different, but can still be made available as an "investigational" drug, which is a much lower, primarily safety, bar.)
- anexprogrammer 10y ago<s> Yes! We could replace those flawed and lobbied against restrictions with advice. The market would be free once again to innovate. Bayer could once again offer Heroin as an addiction free drug. We could get long missed radium cures and snake oil. They could be free to advertise to their heart's content. They can tell us cigarettes are good for us. The companies can be trusted to have our health at heart. They can spend adequately on SEO to ensure their messages are dominant. Silly government warnings and or indivduals having problems with side effects or Heroin forum posts can sensibly be lost in the far reaches of search. </s> Seriously? I can't think of anything more stupid, even though the system is horribly flawed. Want to go back to food adulteration, and poisons sold as cures? Endless advertorials pushing pointless product? We have an entire vitamins and supplements industry that's pointless (and problematic) for most people. Go read the history of those regulations and restrictions. I don't want the pre-drug and food adulteration acts world back, thank you very much. How is this the highest voted post?
- asdfasdfa11112 10y agoIt was under basically the same regulatory regime that Purdue Pharma marketed Oxycontin 12-hour extended release as a drug unlikely to cause abuse. It wasn't that long ago that Phen-Phen (sp?) was legally marketed and sold. We currently allow prescription of extraordinarily strong methamphetamine to children, who often spend their formative years under the influence. --- We still have a long ways to go.
- anexprogrammer 10y agoI did say it was flawed. > currently allow prescription of extraordinarily strong methamphetamine to children As someone adult diagnosed ADHD and taking "extrordinarily strong amphetamine" from my 40s I'd like to point out they do not affect ADHD sufferers in the same way as neuro typicals. They're used at tiny dosages compared to using recreationally. I would not wish children with the condition to have my hugely damaged teen years because of horribly misinformed popular rhetoric about amphetamines. Using meth is the last resort option when other forms haven't worked. That popular rhetoric meant I spent an additional 10 years before gaining effective treatment. I had to read and interpret actual papers to get past the media bullshit and gain an informed opinion. I doubt you can even imagine how much I wish I had been taking "extraordinarily strong", ie correctly dosed, amphetamines from my earliest years. I will add that I'm not in favour of use for weight - many other tactics can work there. Do you use the term "extrordinarily strong" when you mean "correct dosage" or speaking of paracetamol? Paracetamol is the cause of many deaths unlike amphetamines. Now add the liver damage.
- nommm-nommm 10y agoUmmm... Artifical transfats have already been outlawed. http://www.cnn.com/2015/06/16/health/fda-trans-fat/ http://www.cnn.com/2015/06/16/health/fda-trans-fat/
- tmuir 10y agoYou are describing a world in which all decisions made by all humans are informed by perfect logic. The beautiful paradox of such a world is that wouldn't require any government, or any other external system of control. Any external system of control in a perfectly logical and rational world would be unable to demonstrate any value whatsoever, as there would be no conflicts to resolve whatsoever. Thus, in lieu of 100% of humans being 100% rational, 100% of the time, a nonzero amount of government, creating nonzero amounts of regulation it is an absolute necessity.
- jwatte 10y agoThe strip mining of the public good that drug companies would do if all sales were allowed boggles the mind. Such an open policy would only work if all information (including internal information proprietary to the maker) was available to inform buyers, and while I think a fully informed market w would be great, I don't see any real chance of that happening.
- SixSigma 10y agoGovt everywhere : "Don't be obese" Result: highest rate of obesity in history
- BeetleB 10y ago>A whole raft of restrictions could be converted to warnings and recommendations, freeing up industry to innovate and consumers to take a little more responsibility for themselves. When I look at how little regard people have for this when taking supplements, I find it hard to believe they'll take more responsibility for themselves. Not against all supplements myself, but once I learned how poorly controlled they are - how there is virtually no manufacturer I can trust who is actually giving me what the label claims (so many mg of nutrition per capsule, harmful ingredients not on the labeling, etc) - I pretty much stopped taking all of them. The risks outweigh the benefits.