Conflicts of Interest
Dean
Hmm. It appears that members of FDA panels that approve drugs also routinely receive money from drug companies.
You know, drug companies do a tremendous amount of good in the world. I also often think the FDA does as much harm as good, by holding up the release of drugs instead of just informing patients of risks and letting them make their own choices.
Still: am I the only one who thinks there's a fundamental conflict of interest issue when people who are supposed to monitor safety also have profitable arrangements with those whose work they are overseeing?
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I work for the gov't and I can't give my boss a gift worth more than $10. I can't accept a gift worth more than some equally low number, I don't remember as I don't get any offers of gifts.
I am pretty disgusted by this.
While I am pretty supportive of drug companies as they have made life better and longer this just ain't right.
They only stopped them from that THIS YEAR.
I think that it's another example of good intentions which may well have gone quite awry. IIRC Derek Lowe over at In the Pipeline (at Corante) discussed this a few weeks ago. I'll dry to find a link.
Anecdotal data from all the patients taking a drug is much less helpful than a clinically-controlled study. Of course, those studies delay release of a drug that might help people. But it also might prevent the release of a drug which kills people with long-term use. You can't test for long-term side-effects without a long-term study. It's as simple as that.
Also, on letting people decide on their own level of risk, I agree with that in principle, but the problem is that the average lay-person doesn't have the scientific background needed to make an accurate assessment of those risks. Need an example? How about smokers? People will almost always choose immediate gratification over long-term health. Does it mean they shouldn't be allowed to choose? No. Just that we need to be careful to handle it right, instead of just telling people "You're on your own. Figure it out."
On the other thing though, the panel's taking money, we're agreed that that's a problem.
Barney Fife => Protecting public from death row inmates at San Quentin.
Hank "The analogy man" Barnes
After all the US avoided the thalidomide tragedy which afflicted Europe and Canada in the late fifties and early sixties by erring on the side of caution.
Some drugs are beneficial, most probably are snake oil and some are positively harmful snake oil.
As an unrepentant free marketeer I have a natural aversion to regulatory bodies, however in this case a 'neutral' arbitor of the risks and benefits of a particular treatment serves a useful purpose
Clearly those involved in the approval of drugs should NOT have financial links with the Drug companies.
Rather than holding the drugs up, make drug companies compete for better ratings classifications on their drugs. That's win/win.
Andrei: Yes, I'm very familiar with the thalidomide case--and it strikes me that it's been 50 years and that's still the only example anyone can ever think of of the FDA really protecting people.
If you allow companies to release a class D drug, you also have to have some legal protection against lawsuit for the companies. After all, they are making people aware of the risks, etc. (if you don't offer such protection, then allowing them to release it as a class D and preventing their release are not remarkably different as few major companies are going to risk widespread class action suits, which is something that holds up a lot of drug and vaccine research even with the FDA restrictions in place now).
That would then create a situation where compaines have a good financial incentive to simply release products with limited testing on the public as class D and use the results of that release as their test. Sure, they would have to do clinical testing to get a higher class status for the drug, but the effectiveness and safety observed from the class D release would be used to determine if that was profitable.
It's a messy system either way and what we have now is certainly not perfect, but it appears to me to be better than any of the alternatives that I have seen. And I say this while working for a company that is waiting to have products approved by the FDA. ;)
Barney Fife => Protecting public from death row inmates at San Quentin.
Hank "The analogy man" Barnes"
Hilarious! Thank you!
Please stop confusing the approval committee with the employees of FDA. I work for FDA (as a chemist). Not only am I not allowed to accept gifts of more than nominal value, I can't have any outside source of income without prior official approval (except for spouse's income, and there are restrictions on who the spouse can work for), neither I nor my spouse can own stock in any FDA regulated company (FDA regulates a larger portion of the GDP than any other agency), and on a yearly basis I must sign a form declaring all of my assets (second homes, vacation property, stocks, bonds, mutual funds, trust funds, jointly owned assets, etc), all debts (as well as to whom they are owed) and all other outside interests. Everyone in FDA from the commissioner on down is subject to these rules. The approval committee is separate from the agency.
jan
Surely after generations of experience with the FDA we can do better than a binary yes/no choice, yes?
The question of medical insurance strikes me as a quibble, frankly. Rudimentary insurance would only pay for class A drugs. Slightly better insurance would pay for class A or B. Really good insurance, maybe further than that. And so on and so forth. I mean, that's what we pay insurance actuaries to do.
What if you're poor and can't afford the Class D drug? Well shit, you do what poor people always do what they do when they can't afford an expensive surgery or other treatment. You go to charity, you raise funds from friends, whatever. I mean, how is that different from now, except we now have this authoritarian agency which has the power to say, "NO, YOU MAY NOT HAVE THIS DRUG NO MATTER WHAT BECAUSE WE KNOW WHAT'S GOOD FOR YOU WHETHER YOU AGREE OR NOT."
We have this absurd, binary, FDA yes/FDA no system which makes no fucking sense. From one direction it holds up potentially useful medications that could save lives or improve quality of life. From another direction, it tells us that drugs are "safe" when they may not be safe at all.
We can do better I'd think.
Correct me if I'm wrong, but from what you say, it sounds like the approval committee is a bunch of experts working for various places, which the FDA trusts.
That would mean that the only problem is that the FDA thinks that some people who work for drug companies are objective and trustworthy. That would be easy to fix, if you considered it a problem.
What happens when several people take a class D drug and it is discovered that it leads to multiple deaths? Do you hold the company accountable? If so, how can you justify allowing them to sell the product and punishing them for selling the product? If not, how do you protect the population from becoming the primary drug trail method, leading to harm? For that matter, how do you prevent companies from selling false hope to people and defrauding them from money? How do you continue to stimulate research into safer and more effective drugs, when there is little profit in it?
I agree with you that there are likely ways to make your system workable. I just don't believe that the end result would be any better that what we have, and I suspect that it would be worse. I think that it would simply shift the problem. It may allow for the quicker release of good drugs, but it brings with it the release of many ineffective and/or dangerous drugs.
The system we have now is not about the FDA telling people what is and isn't good for them (although that does happen to an extent, it is a side effect). The main purpose of the FDA is to force companies to prove that their products are safe and effective. That is not an easy thing to do for many drug companies and it does delay the release of many drugs. Sometimes that is of no real benefit. Other times it makes the final product better as things are discovered in the clinical trials.
The drug companies would still be sued by people taking 'D' and 'C' class drugs. They could sign the most detailed waiver, in triplicate, in blood and they would still sue. It's for the children.
15 Years ago I thought tobacco suits were ridiculous. Some people whose every pack of cigarettes had the Surgeon General's warning still got millions of dollars.