Here’s my colleague Dan Klein arguing — effectively, in my opinion — for denationalizing the process of approving drugs. The clip lasts about seven-and-a-half minutes. It is well worth watching.
Denationalizing the Drug-Approval Process
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What about Health Insurance companies and Medicare which determine what drugs are covered and how much under there plan?
Reality of today’s life:
Doctor’s consider which drugs are covered under the patients Health Coverage when prescribing medication.
Isn't the FDA's overriding mandate to ensure patient safety? Any loosening of regulation will be viewed by the public as compromising safety. This perception will be aided and abetted by lawyers who will sue for damages, regardless of the truth. Sympathy will be gathered for the poor victim of loosened and 'inadequate' regulation should any drug cause a bad reaction. A replay of what happened to Merck with Vioxx comes to mind, even if no data-hiding is uncovered. Sorry, but I think this is a wonderful ideal that won't survive in the real world.
I wasn't particularly persuaded by the argument that doctors wouldn't be prescribing dangerous medicines for their patients. Of course they wouldn't *knowingly* do so, but the drug approval process ensures some discovery of the side effects of the drugs and delivery of that information to prescribers. This is important information for Doctors and it's not altogether clear that it would be as available to them under Dan's regulatory scheme.
Also, my impression is that there is already a lot of cooperation between the FDA and EMEA, to the point that the activities for approval by one are nearly exactly the activities needed for approval by the other. It's not exact, but the regulatory costs do not double when you go to another market.
Why should drug approval be a government function at all, regardless if the drug companies get to choose the governement (US versus Canada versus Japan etc.)? Why cannot the private sector labs and testing companies (like UL is for electronics) be used and if there is any truth that the freemarket is more effecient than government, it will be faster, cheaper AND safer.
Like Bill K. and Chris I am skeptical.
The sheer craziness of this nation's policies leave me dizzy. In the last 9 years I have come to believe that as I move through life, if the person in front of isn't behind a cash register or serving my food, I feel as if the odds I am dealing with a plaintiff's attorney is extremely high. There is just so damn many of them.
And, a world full of plaintiff's attorneys is no safe place for honest people.
Any adult can buy tobacco and Peanut Butter but not Vioxx even though we know for "dead certain" sure that use of tobacco kills more people in any single minute than Vioxx has in its entire existence. And, Peanut Butter has a research documented death trail that exceeds Vioxx.
The irony of that is that use of tobacco is voluntary and in full awareness of its well known and well publicized dangers. Even so, those who develop lung cancer still have access to our courts to sue for damages. Those who bought Peanut Butter and demonstrate an allergy to it which perhaps nearly causes death or perhaps even does kill, have access to our courts to sue for damages, even though the possibilities of that allergy are clearly known by the public.
Vioxx on the other hand has a risk to "some" people and it is extremely difficult to make an intelligent research documented case that Vioxx caused death.
Every single case I have sat through regarding lawsuits over Vioxx, and other drugs, have claimed the drug as the cause but the case is presented from the emotional side than the factual side. This is also true of cases involving tobacco and nut allergies. Lawyers do not try to prove direct causation by the substance, they concentrate on the hurt, sorrow, or loss "caused" by the death that they attributed to the substance. Juries reward more often on the basis of emotion than rational, because after all "big business" has deep pockets and "won't miss it".
So, there is some of the irony that prevades our system regarding the legality and availability of substances that harm or may harm a human being.
I really do support either eliminating or totally doing away with the FDA. That is iron clad. In the real world with real people there is no need for it. However, we no longer live in the real world. Our world contains a vast number of people that have been indoctrinated in irresponsibility via the socialist school system and have turned out like muirduck, RN, Trumpit, Gil, nunya, et al. People who think government can and does deliver a perfect world when it is socialist.
Those like listed in the last paragraph are dangerously and deliberately stupid as well as willfully immoral and criminal. They are out here, driving that car next to you in traffic, serving your food, teaching your children, the union member servicing that airplane you're about to board, etc. They believe that the ultimate responsibility is the governments so they can do as they choose at the moment and if bad happens the government is there to make it all whole again.
These people claim damages and sue a doctor even though the doctor has documented evidence that they were told that procedures carried risk, exactly what those risks were, and that the doctor himself refuses to proceed without directeds signed documentation that the patient is accepting the risks and give permission to proceed. No two humans are the same, the risk happens as explained, the patient is harmed or dies, and our socialist courts accept the lawsuit in spite of it all. (makes me wonder what sane individual would even go into medicine) That is the world we live in.
An example: A slack-jaw alcoholic with a history of health problems had a sore throat. After a long day of sun and boozing at Pensacola beach and on the way back to his motel he bought a bottle of a common and popular medicine to treat his sore throat. Clearly printed on the box and the bottle label are the dosage instructions. He offered testimony that he chugged half the bottle as his first dose and finished off the bottle four hours later. During the night he had bad chest pain and symptoms that caused him to be taken to the emergency room by his girlfriend. The diagnosis was a heart attack. He had a typical plaintiff's attorney just beating up on the drug manufacturer for causing his client's heart attack.
I buy a drug and I get 1/4 ounce of pills and six ounces of printed safety and use warnings which I am directed to read.
That being said, my critique of the content of the video is that the gentleman is weak on street instincts about what really is out here happening on the street.
To enact the sensible suggestions made by Dan Klien would require a complete revamping and overhaul of our legal system from top to bottom. It would require a complete re-education program introducing the notion of self responsibility and personal liability. Otherwise our courts would become instantly the largest employment sector in our nation.
Last but not least let me direct your attention to the fact that many doctors are whores as well and care more about the dollar than the patient. I see them face to face on a regular basis. They will prescribe what the patient wants. They will testify to illogical and irrational interpretations of data, all to support the $2.000 per hour fee they charge for their prostitution.
Claiming the doctor as the last and best line of defense against harmful drugs may be as risky as just shotgunning them out over the counter.
Sorry to be so cynical but if you haven't seen what I've seen or heard what I have heard then you have no idea of how careless doctors can be, nor how stupid and venal people can be.
Very good piece.I agree,somewhat,with John Smith.The propsed plan could be a further Field Day for lawyers.Don't physicians currently rely, to a great extent, on pharmaceutical salesman for their drug information? Ditto pharmacists? The liability needs to be limited.Milton Friedman did say that the AMA was the most powerful trade union in the world. The ABA must be right behind it.
Of course, if a drug doesn't work it won't be used.
Just concerned, not with the ideas of this proposed plan, but for the potential for abuse by legal groups and big Pharma of the institution that would develop from them.They might fill the void created by a reduced FDA.Don't want to throw the baby out with the bath water. Still,as stated by Mr.Klein,drug development delays have cost us dearly.An analogy might be made to our economy.As great as our standard of living is, think how much better with out restrictive regulations?