The FDA has announced that Scott Gottlieb, their guy in charge of science, is leaving, headed back to his spiritual home, The American Enterprise Institute, denizen of right wing ideologues and other apologists for do-nothing government. As the American Enterprise Institue describe themselves:
The American Enterprise Institute for Public Policy Research is dedicated to preserving and strengthening the foundations of freedom--limited government, private enterprise, vital cultural and political institutions, and a strong foreign policy and national defense--through scholarly research, open debate, and publications.
It seems like only yesterday we were warmly welcoming Dr. Gottlieb as he was brought on by former Commissioner Lester Crawford, now under investigation for failing to disclose interests in matters related to his own agency's regulatory responsibilities. Gottlieb's departure was announced just as the new Commissioner, Andrew von Eschenbach, was confirmed. Coincidence? Maybe. Anyway, he'll be gone by January 16, just before the new Congress, armed with sbupoena power, takes over. Coincidence? Maybe.
Announcing Gottlieb's impending departure, von Eschenbach praised him thusly:
"Throughout Scott's tenure at both FDA and the Centers for Medicare and Medicaid Services (CMS), he has served the public health with tireless dedication,? said Commissioner of Food and Drugs Dr. Andrew von Eschenbach. (FDA Press Release)
Tireless? It seems he got tired of being Deputy Commissioner for Medical and Scientific Affairs after only 18 months. Maybe it was those full days working on the people's business that did him in:
An internist, Dr. Gottlieb continued to practice medicine during his tenure as a public health official. (FDA Press Release)
Guess not. Well, the FDA will now have to find someone else to carry on Gottlieb's sterling record of improving the FDA advisory committee process. Big job, that. I'm sure he will remain a trusted advisor from high atop his subterranean perch under the rock where the American Enterprise Institute is no doubt planning how to get us into the next war by fighting for freedom abroad while protecting American women from reproductive freedom at home.
So it's back to AEI for Dr. Gottlieb. If he ever left.
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Revere,
This is not a comment, but a question.
This morning's (Australian) papers carried a story about a drug that stopped a cancer, (by stopping growth of blood vessels in the tumor), but indicated that it could be 2 more years before it was approved.
I suspect that holdup is the FDA. Apparently the FDA requires v.expensive testing before certifying a drug as safe, effective etc.
My question is, why have this "pass" or "fail" system? Why not use a grading system.
e.g. Doctor to patient: "Gee George, good news, there is a drug that might cure your cancer. Bad news is, you will 95% probability die within 1 year, but the drug is not released for two years".
I suggest that the FDA have levels of certification, from "High Distinction" meaning it will probably be effective, & might not be lethal in most cases, to "Pass" which might mean that it seems to work about 50% of the time, and that we think there is a 9% chance that it wont give you a heart attack within 12 months".
The point is, the only people who benefit at the moment seem to be Big Pharma. Why can't the FDA maintain a list of drugs and their alleged curative properties, and indicate test results to date, and reliability of those results?
It is no good protecting a person from a side effect ( possible heart attack?) in three years if in the meantime the cancer will kill them in one year.
And might I point out, all of those willing to use less than fully tested drugs will help by increasing knowledge about efficacy.
The world is so upside-down. I didn't read the quote quite right and spent quite a long time trying to figure out what "freedom-limited government" might mean and why a group would openly promote such a concept.
Of course I'm fresh from reading the AP article about Bush requiring federal scientists to report only facts that conform to policies, instead of crafting policies to fit the facts. The world is so upside-down....
Susan-Did you not read the article? There was apparently criminal activity involving Yucca Mountain during the Clinton years that started this investigation.
Another good example of this is the whipsaw effect of having every scientist out there that works for the government making "policy" statements. If you were working for a company and you made statements you couldnt back up to the press and even if you could the official regulations regarding this were that you were not to do it, you should be fired.
Some will interpret this as muzzling of the scientists. Suppression of free thought. Uh huh. They always say that. Thats what the paper submission proceedings are for and the press office for every government agency. If you worked for that major corporation and you did it, you would be gone regardless if you made a statement to the press. Its not their job. If the administration says the world is flat, then sure everyone can argue about it but not when you have a official job to do. Its not to produce a desired result... I sent something to Revere and MIH that totally contradicts Gore, but no one lost their jobs over it. It shows a huge disparity in what the "official" Clinton/Gore line was and is. An Inconvenient Truth was pure crap and unsubstantiated by anything provable.
Its just part of the litigious nature of our society. Global warming? Lets sue! Please, if you can prove that its because of mans influence only. Good luck. Not going to be able to do it. Its just another methodology to ensure that the "company line" is a company line. I wouldnt want government employees making statements they cant back up and they simply cant with provable science.
They can always publish their interpretation of data outside of the government channels. They get paid to do a job. Unless they are off the clock and their job classification says, "make unfounded public statements" they should be terminated. We DO have a system for whistleblowers too now and if someone cares to involve themselves in the legal system they can follow that procedure too..
Look I am not discounting what you or Revere say about this. The guy was a jerk and ultra-rightist. Not a member of my Party. But its just not the process. Bitch about it, change it but when its within the constraints of the law dont sit there and say so and so was such an asshole when he was put in by people who were elected by the people. Indict them if you thnk that the law was broken. The will of the people have changed the Congress, get the Dems to make a new law... No assholes in office. The country will self destruct the next day.
Randy: Yes, we are a litigious socieity, but it's not ordinary people who are suing. It's businesses. 90% of all cases in civil court are business contract cases. Much of this is due to the fact that businesses have created such a legal tangle by messing around in the laws themselves that everything is subject to dispute if you want to. Plus lawyers make money by doing this. Not trial lawyers. Business and corporate lawyers from big firms who argue with each other over contracts. So if you want to clear up the court system, start with the 90% that's there, not the tiny minority of lawsuits that make the newspapers.
I have a post queued up for this evening on Susan's story which I wrote last night so she and you will get my take on it. The Clintonistas did mess around, too, although not to the extent that the Bushies have done. They are true outliers in a tradition that is old but they have taken to new heights. There are simple remedies for having scientific papers not represented as gov't policy that have been used for decades, like disclaimers. Not good enough for the Bushies. Oh, well. You'll see what I think this evening.
bar: New drugs are tested on people in clinical trials, so the information is being generated. The approval process is arduous and there are provisions for extraordinary use (I'm not a drug expert so I can't remember what they are called in the US system). Australia can do what it wants on drug approval and doesn't have to follow the US. Anti vascularization drugs for cancer area already in use (Avastin, for example), so this isn't a breakthrough, just another drug they want to market that maybe is better and maybe not.