Tuesday, December 18, 2007

Addendum to Provenge Label: Warning! Might expose FDA inefficiences..

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Okay, so the first two Congressmen started expressing their "Provenge" displeasure and I thought, oh well, what is two Congressmen. After all, under President Bush, most federal agencies have weathered an entire Congress!

And then one more added himself to the list and Three's Company of course, so I thought, might as well roll out my cynical red carpet...

The gist of the story is that the panel that reviewed Provenge had atleast one guy working for a competing company, Novacea. How did he get to sit on the panel anyway? Apart from violating fundamental ethics, was he also able to access sensitive data on Provenge? Is the FDA performing the dual function of being unethical and destroying competitiveness?

So, in the future everytime the FDA rejects a drug, are we to spend immense time and energy investigating and/or lamenting over whether or not the rejection was appropriate?

Heck, it atleast gets a few Congressmen to do something..anything!

However, now let's take a step back into this month's favorite cliche: Riegel (with all respect to the deceased).

So, the FDA, the attorney general and anyone who considers themselves an expert (including the lawyer who doesn't believe in juries) went in front of the Supreme Court or blogorama as they saw fit, to argue in favor of federal pre-emption.

But we go back to the age old question that Will Smith asked in that spy movie, "Who watches those who watch us?"

And if we claim that the FDA knows better than the jury because it employs a "panel of experts" who are somehow better than 12 high school educated folks, how would you explain all the hullaboo surrounding Provenge?

Even 12 year olds know thats not the right thing to do!

IMO, by taking up the Riegel case, the Supreme Court has snatched itself a nice little commonsense vacuum. With low funding, low morale and definitely lower ethics, the FDA is now an aging dinosaur - just refer back to my post on the "new" DES rules..

All our friendly, neighborhood Supreme Court Justices run the risk of stepping on some 'caca' for suggesting that the FDA is above "torts" and has its own "experts" who will keep us all safe....a very dubious and unbelievable statement indeed.

Meanwhile, do you have any hope for some good to come out of the potential Provenge investigation? Do Congressional investigations actually result in any good?

I have a suggestion: Try to make the panel immaculate (not religiously, and this is the season when Discovery Channel tries to show through reruns that nothing can happen immaculately! - sorry for the spoiler!!!). That is, there should not be folks with conflicts in the panel. If you had a prostate cancer panel of 14 guys, none of them should be working on ANY prostate cancer drugs, maybe even cancer drugs.

Am I suggesting that 14 such folks can be found among a population of 300 million (and counting)?


Whenever that's not possible: Pick rotating panels of experts from the FDA. Let them keep serving their commercial masters. But come time for applications (which the FDA can set starting from 3 - 6 months prior to the actual review date), the FDA should set a period where it decrees that the panelists should stop any conflicting work which might include accruing current benefits (like salary, bonuses etc). They can pick up conflicting businesses once the decision is made. Given the potential "upping" to the resume that serving on FDA panels brings, I doubt if many will protest this with vigor.

Then again, don't blame it entirely on the panel. This is where the irony of the FDA's argument in Riegel sets in. The Provenge panel did recommend an approval. The panel is support to be the expert..and a 13-4 vote is not contentious. So, who then got to decide to screw Provenge over?

What would be the point of arguing that panels know better than juries and then not listening to panels? We might as well do a TV program where out-of-work parttime bartenders could review drug applications...

So, is an investigation necessary? Yes.

Is there a better way for the FDA to function? Yes

Transparency somehow appears to be a potential keyword in this business...so does commonsense!

But hey, why listen to me..after all the FDA has its own experts!!!

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