The Merck/FDA problem.

[Guest]

If an FDA regulator accepts a job at a corporation, what could he possibly do at that job to 'grease corporate cogs'? What do you mean by that?

I mean that an FDA regulator may be more likely to be in favor of approving a drug made by a company that's offered him a job.

Would you rather have our food drugs regulated by people who came out of the construction industry?

Look: the ideal--and most sane--situation would be to have scientists set up a comission with no ties to either the FDA or the pharmaceutical companies regulated by them. I.e., an independent, scientifically comprised comission with no conflicts of interest--not construction workers. However, the fact that I've had to spell this out for you indicates that it would be both insulting to me and a waste of my time to continue this discussion. I really don't mean to be condescending, but I also don't want to spend half of each of my posts explaining to you what I presumed (not arrogantly, I believe) to be very obvious.

 

[The Gardener]

I agree, Alopecia-Nate. There is some incestuous sh*t going on with the regulators.

But, when it comes to our government on MOST issues (NOT foreign policy nor Iraq!), I tend to think that they generally have their sh*t together. Think of how many medicines the FDA has had to review in the last year. Now, think of the number of medicines that they have fucked up on. Divide B by A. Methinks the percentage of successful regulation is probably ninety-nine point something.

There are more dramatic examples of this incestuousness than the FDA. The Pentagon/Boeing thang with the airborne refuelling tankers got me incensed. Thank God for John McCain, he was the one who nipped that in the bud. I, too, happen to be a big fan of his.

 

[Bryan]

And I'm SAYING you haven't built a case for the assumption that accepting a job at Merck, fresh out of the FDA (or vice-versa) is a sure sign of corporate/government hankey-pankey!

Yeah, good call--let's make it OK for people who regulate the products drug companies produce to later accept jobs from said companies; not much chance of anyone wanting to grease the wheels of the corporate cogs there.

Yeah, now that I think about it, I'm sure you're right about that. I bet something similar to the following hypothetical conversation happens almost every day at the FDA (it's early Monday morning in an FDA office in Washington DC. Ring-ring goes the telephone...):

FDA: "Hello. FDA. Dr. Smith speaking."

"Hey, Bob! It's me, Jack."

FDA: "Jack! How ya doing, guy? How are things over at ABC Pharmaceuticals? We missed you here at the Christmas party last week! Things here just aren't the same without you."

"Thanks for that, Bob. Yeah, things are going well here. Be sure and tell Nancy and the kids that I said hi."

FDA: "Will do. So what can I do for you?"

"Well, we've got a little problem here at ABC: we're developing a new drug for hairloss that we've named 'Ultrasteride'. It's a combination dual 5a-reductase inhibitor and androgen receptor blocker, and it specifically targets hair follicles only. We're about to submit it to you guys for approval."

FDA: "Great! So what's the problem?"

"Well, we've run into a small snag with some teratogenic effects: in animal tests with the drug, about 1 out of 50 offspring are born with two heads."

[lowers voice to almost a whisper]
FDA: "Uh-oh. I suppose you want to go with our usual arrangement?"

[whispering]
"Yes. A case of Jack Daniels to all the Examiners, and I'll even throw in a case of that fancy French wine just for the Commissioner. Agreed?"

FDA: "Ok, Jack, you drive a hard bargain! [Laughter from both sides] Something tells me that 'Ultrasteride' is going to slip through and get approved without too much trouble!"

"Ok Bob, I better get back to work. Thanks again!"

FDA: "Sure, Jack. Let me know if you need any more help. Bye!"

 

[Guest]

Bryan, you are what I would call an NTAC. I've had to spell everything else out for you; not going to spell this out.