City Journal Autumn 2014

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Douglas Holtz-Eakin and Paul Howard
Liberating Medicine’s New Frontier « Back to Story

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Well torte-reform is the reason why healthcare is expensive...cars don't run and a host of other societal ills but as long as they like their union buddies gives kickbacks to their fellow gangstas, nothing is going to change. It's a truly sad story that we've become a sclerotic lazy society because there is a waiver attached to anything and everything except what is Made in China. You just know something is seriously wrong.
I think the FDA and the rate of approval for new medical devices and drugs has very little to do with the overall health of Americans, and their effects are mostly measured in days of extra survival for the already critically ill. In short, they are mostly extending your death rather than your active life.
Studies seem to support that all the major medical advances of the 20th and 21st century have increased the average human life span a matter of weeks.
I have several friends who are in the medical professions and I read a lot of the studies.

Want to increase your active healthy life span? Don't smoke, don't drink heavily, don't take drugs you don't need, keep your weight down, and keep your sex life clean and safe. Stay active. Then remind yourself, that ultimately "death" is inevitable for all of us.
All the drugs and devices in the world won't correct what most people do to themselves.
It is also important to remember that approving more drugs only helps if they do what they're supposed to do. Otherwise it's worse than nothing. Given the sheer number of studies many are going to be falsely positive from random chance. Others don't answer the question you want. When was the last time you saw a new antibiotic compared with an old one head to head? I certainly agree that it would be better to get drugs approved quicker and easier and that the fda has room to improve. However its not as simple as just saying require less patients. Those numbers are there for a reason. If we decrease them we will almost certainly have even more drugs on the market that don't actually do what they say they do.
It is unclear what credibility Douglas Holtz-Eakin has when it comes to discussing economic benefit and medical matters in this country. He is the same shill that rubber stamped Medicare Part D from the congressional budget office which was of course a gift to Pharma.
This is a great article which opens a really hot topic. I would not blame the FDA for all evils in the pharma industry, as to me they with all their shortcomings look more like the last man standing. FDA was in fact the only agency which refused to approve thalidomide on the US market because of safety concerns and rejected the application at time when Europe was flying high on this hit. In the UK, the most commonly prescribed drug containing thalidomide was Distival, product of a firm specialized in liquors which sought to enter the market with tranquilizers. Everybody knows what happened - in Europe, there were about 10.000 children born with serious malformations to mothers who were taking thalidomide in first trimester. Thalidomide now has use as a drug for leprosy, but the risk management is at a completely different level. http://www.thalidomidesociety.co.uk/thalhistory.htm
http://www.nyu.edu/classes/jaeger/thalidomide.htm

One has to remember that most pharmaceutical corporations are multinational, and the business is global in nature, what means that law enforcement in the industry has got to be global as well. I personally do not think that letting the corporations to move strategic industry, what manufacturing of active pharmaceutical ingredients clearly is, to a different jurisdiction where it is difficult to enforce even the most basic standards, is a good idea. In fact, FDA has now subsidiaries in India because it could not rely solely on local regulators. http://www.fda-mah.com/Contactus.aspx

The fact that there are more people involved in clinical trials than ever before brings back yet another very unpleasant memory, and it is the fact that clinical trials were not always conducted in a civilized and humane manner on people who gave informed consent to it.

As most people remember from WW2 history, the whole point of the war was robbing and elimination of certain undesirable groups of people who also became involuntary participants in medical experiments. The medical cases NMT1, 2, and 4 (USA vs. Karl Brandt, Erhard Milch, and Oswald Pohl) as presented at the Nuremberg military tribunal are available at the web of Harvard Law School. It is a very interesting reading indeed. http://nuremberg.law.harvard.edu/php/docs_swi.php?DI=1&text=nur_13tr

What I want to say is that it would be very unfortunate to outsource accountability for enforcement of standards in clinical trials to countries with substandard human rights record and see some real crazy human rights abuse once again.