Former hedge fund manager acquires life-saving drug, raises price 5,555% to $750/pill

Answer: The FDA. Those kids were able to synthesize the drug. They aren't unique. Lots of entities can synthesize that drug easily and relatively cheaply. Unfortunately, we don't have a free market that allows any of them to market it (and compete with each other *as insane is that concept is*). Martin Shrkeli is a prime example of us reaping what we sowed.

 

Unfortunately for every thalidomide the FDA has kept from coming to market, it has done way more harm than it could possibly have prevented, by greatly increasing costs of R&D, and as a result reducing the supply of new and innovative drugs. People don't consider this well enough. It costs more than a billion dollars to get a drug through their web of corruption and buerocracy. The societal cost of that? It is in addition to the billions of dollars the FDA costs us each year directly. All of that money prevents a ton of GOOD medical therapies. There is a graveyard of never approved, but potentially life changing / saving drugs that the FDA has left in its wake.

How many people have died because of the years of delays the FDA has caused with its tortuous process? "Thalidomide" as a stock answer doesn't consider that trade off and really try to discern whether the harm it causes is way outweighs the good. It's compounded by the fact that the FDA doesn't just function with regard to approval. It's web has become so big and so expansive, that, for example, the FDA and it's dumb regulation is the reason why Mylan and Turing and Valeant (and others) have old drugs that they have jacked the costs of. You can add that to the societal costs the FDA has imposed on us -- meaning that our health care in the aggregate suffers. The FDA throws roadblocks in your way if you want to market something, and it forces you to spend an insane amount of money to market a drug or device. Of course it has kept some harmful drugs off the market. That has come with a great cost, though, keeping beneficial drugs off the market, too. Take away the FDA and you lose that cost. ... but it doesn't have to mean the Chinese flooding us with products full of formaldehyde. It means we're all more responsible for taking a stake in our lives -- rather than thinking there is a Big Brother / nanny out there that can fix everything. I am a stranger. If I stuck some strange looking thing in front of you and said "eat it, trust me!" would you do it without the FDA telling you what to do?

 

You aren't an expert on lots of things. How have you gotten through life without every decision being made for you by a nanny? I mean, have you ever gotten on an airplane, even though you aren't an expert on all of their engineering systems and you weren't allowed to give it a thorough inspection yourself before you took off? How did you choose a car that best suited you without being an expert on how to make one?

Drug / device trials, publication, etc. don't require the FDA and all the problems that come with it. The fact is, the FDA goes well beyond the kinds of trials necessary to produce safe, effective drugs and devices. They have become a monstrosity concerned with 1) expanding their own powers, and 2) creating costly bureaucratic roadblocks that meet all kinds of politicized objectives but have zero to do with safety.

Trials, publication, sharing knowledge, etc. themselves? Those things all existed before the FDA. When you go to a doctor or some other medical professional you are putting your well being in their hands -- their judgment, their knowledge, their ability to synthesize a lot of information regarding medicine that you can't or don't want to. You don't go to medical school before having your blood pressure measured. At some level, you always have to find good people whose expertise you trust, and rely on those people to get the things you want. It goes beyond medicine, although I get that medicine is particularly important to people because it can be life or death.

Take away the FDA and all that comes with it. Good doctors are not going to prescribe you potentially harmful things that have not been tested via trials and shown to be effective. If there are doctors like that, they aren't going to have their careers very long -- either because of the liability they subjected themselves to, or the fact that they are not going to attract patients (who are looking for good, trustworthy, reliable doctors). It may be more important to most people. But it's no different than when you buy any product or service. You don't go in blind. You ask your friends and look for vendors that have satisfied a lot of people. You go to consumer reports. And once you find someone who is reliable, you keep giving them your business.

 

In bureaucratic acronyms you trust!

For what it is worth. ... Despite some certificate that a wholly unnecessary agency slapped on an aircraft (as if airlines don't have it in their own interests to tend to their planes and make sure that they are safe). . ... Unless they were there to supervise the guy who was servicing the plane before you took off. ... you had better get off and start taking the thing apart yourself before trusting that it's going to stay in the sky. In between learning chemistry, that is.

This is a simplistic statement, of course, but I don't think it is entirely a coincidence that the golden age in this country largely ended with the advent of the FDA, EPA, SEC, FCC, etc. It's a sad indictment of what we have become to me that your kind of thinking is prevalent. How did we manage to prosper economically and grow in a way we don't anymore. ... WITHOUT "ammoral" entities callously killing off the masses. ... before everything was put under the purview of an inefficient three-letter bureaucracy?