I stumbled across an interesting wikipedia article about the Food and Drug Administration that outlined some good criticisms of the FDA. Also, I recently read Milton Friedman’s book, Free to Choose, which made similar points. I have no doubt that the folks who work for the FDA have nothing but concern for the safety of consumers in mind as they conduct their work. However, is the extra layer of security via the FDA a net positive?
When the FDA makes a mistake, one of two things will happen. Either a drug that is harmful will be approved, or a drug that is beneficial will be delayed or unapproved for use. Both of these mistakes will cost lives, but which would the FDA be more fearful of? Surely litigation and sullied reputation would be strong incentives for the FDA not to approve a drug that hurts people, but these same fears of litigation and embarrassment impact the behaviors of the drug companies as well. For this type of mistake, I doubt that the FDA adds much to the protections already in place by the legal system and the market. However, when the FDA delays or rejects a drug that is beneficial or the regulations of the FDA makes drug research so expensive that rare diseases are not worked on by drug companies, who bears the cost of this mistake, and who even knows about it? The sick who could have been helped have no knowledge of the harm caused to them by the FDA.
Is the FDA good for us?
8 comments:
Thalidomide.
Yes, thalidomide.
Of course bad things will happen with or without the FDA, but I think you missed the point of my arguments. Lives are lost when drugs are delayed as well.
I believe that tort reform may go a long way to diffuse this type of dilemma.
What angers me the most about the FDA is how often medication that helps thousands is pulled off the market because it injures one. Nevermind that the person was immunocompromised or that the person did not heed the warnings. If a few people are injured, the masses that may benefit from the drug will not be given the choice of risk.
I didn't miss your point. But where would you move the approval line in the sand to get drugs to market faster to help people without getting them to market so fast that they would hurt people at times, too? It's a gruesome question which I doubt the FDA takes lightly.
And then there's the conflict of interest issues relative to some FDA review staff allowed to also have paid consulting positions with pharmaceutical companies. I would be very concerned about accelerating drug approvals when the regulatory agency has staff that are also compensated by those that stand to make huge sums by accelerated approval schedules.
How would tort reform solve this dilemma? It's the FDA approval timeline freemarket is saying delays getting livesaving drugs to market. Taking it to an absurd extreme, if the FDA timeline were so shortened that pharmas were presented a new business environment where they needed to decide how to best balance profits from accelerated revenues vs. risked losses due to litigation caused by accelerated deliveries, I would be really concerned. In that situation, would artificially limiting pharmas liability via tort reform really be in the public's best interest?
Ford made decisions like that relative to the Pinto, didn't they?
Corporations responsibilities are to their bottom lines, the FDA's responsibility is to be a watchdog, protecting the public welfare.
You can't say that the FDA yanks drugs from the market every time just one person is injured. There's plenty of approved drugs that do have risks, sometimes deadly ones, but some recent cases have been where risks weren't disclosed or labeled on the packages. Would you want known risks not being presented to the pulic or would you rather have the drugs pulled from the market until the risks were verified and then clearly labeled on the packages so people really would have informed choice?
Accelerated approvals? Tort reform? What could go wrong with that? A whole lot.
Great point, Anon11:58. After all, the article states that "Five children died after being treated with the experimental antibiotic and others showed signs of arthritis, although there is no evidence the drug played a part. Six children died while taking a comparison drug."
5 children died on the experimental antibiotic, and 6 on the comparison drug.
Sounds like Freemarket is on to something!
numbersgirl, the article states 100 children were given the experimental drug, but doesn't say how many were given the comparison drug (or other drugs).
It's possible the outcomes for those on the experimental drug were statistically better. It's also possible that neither the experimental drug nor the comparison drug caused the deaths in either group. The article also does not say if other more effective or less risky drugs are available for treating that illness.
However, your 3:17 post, like the article, did emphasize the importance of disclosing risks to the public and letting the public make informed decisions. That disclosure appears to not have happened in the article's situation. Thankfully, regulatory agencies have not approved that drug for use in children in the U.S. or Europe.
The subsequent difficulty in obtaining public disclosure of the experiments and outcomes is all the more problematic relative to the public having informed choice when choosing medical care.
When billions in profit are in play, the public needs protections from those isolated cases where greed-driven abuses can occur.
I'm wholeheartedly in favor of advancing medicine to save lives. But uninformed experimentation is wrong.
Back to the topic, accelerating approval schedules can save lives and can also take lives. The hippocratic oath prohibits doing deliberate harm to anyone for anyone else's interest.
That said, the depth of this discussion thus far doesn't really do the topic justice. Terminally ill people and their families are under considerable duress when making healthcare decisions and need protection from snake oil. People can get access to some drugs prior to FDA approval via more carefully controlled clinical trials. Many other factors also exist.
Experimentation on children is wrong in any circumstance and is a red herring in this discussion.
“Terminally ill people and their families are under considerable duress when making healthcare decisions and need protection from snake oil.”
The only thing terminally ill patients need protection from, in my opinion, is the arrogance of people who insist that a regulatory agency should be able to place limits on their treatment options. This is where we have fundamental disagreement. You seem to want the state to take responsibility for the safety of the public whereas I am of the opinion that the people should be able to have control over their own destiny.
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