I have a right to choose what I put in my body.^ Companies that make drugs have a right to sell what they make, as long as they don't lie or defraud me. Simply by doing what it was created to do, the FDA is violating my rights as a patient, as well as the rights of all of those whose rights give rise to the drug companies (i.e., employees and shareholders).
Suppose that a new regulation passed that eliminated off-label prescriptions. Many will agree that the suffering and death that would result would be immense. (Just ask anyone who has a friend or relative that's benefited from an off-label drug.) Yet off-label prescriptions fly in the face of what the FDA does. What's going on here?
What we choose to do when we're sick ultimately rests on each of us, individually. We all need to be free to do the research ourselves or to delegate this responsibility to whomever each of us has trust in (a particular doctor, for example). The inevitable consequence of losing this freedom is that far more of us suffer and die today than would otherwise.
The valid function of the FDA (valid insofar as it is a source of scientific information) should be performed by a private organization like Consumer Reports, which has a great deal of authority, but is completely independent of both companies and the government. Consumer Reports doesn't use violence or the threat of violence to back itself up: the one thing that keeps it in business is trust.
Certainly, Consumer Reports doesn't offer its products or services for gratis. But many people find the service valuable enough to pay, and with our bodies, the stakes are much higher. Most people will pay for such a drug-vetting service, either directly or through the professional they delegate health decisions to.
We all want safe drugs, and the market is capable of producing and selling safe drugs to us. All we need is to be left free (meaning that the government does one thing only: prevent force and fraud), and verification organizations that pride themselves on true independence will arise.
^This right over your own body really is absolute (so long as you're not hurting someone else). I don't use or advocate for the use of illegal drugs, but it really is no one's business but your own. Yaron Brook recently summed it up best when he said, "You know you're in trouble when you declare war on inanimate objects."
Indeed. The genomics community is currently very angry at the FDA, as a senior official (CDRH director Jeffrey Shuren) appears to have been caught red handed lying under oath:
www.youtube.com/watch?v=YI-m2Cucdoo
His stated rationale is that increased FDA regulation against startups will help the"traditional manufacturers". No, really. Watch the whole thing.
That's all wonderful etc., but unfortunately it's Utopian pie in the sky which can never come to pass in a democracy. When people die owing to other people making mistakes, the people demand the government takes action, and it does, and there goes your libertarian wonderland.
To the downvoters out there: if you're serious about this problem, you need to live in the real world. That would be more productive.
I dont understand. If the FDA wants to incentivize private companies to update the research on old drugs, why dont they just pay them to do it (AND not make the payment contingent on finding the drug marketable as this appears to do)? Obviously nobody knows the true value of new research on old drugs, but giving private companies blank checks to insurer's bank accounts doesnt seem like the best method to go about it.
Actually, some kind of prize system - setting a reward for a drug which has a certain degree of efficacy on some problem - has been proposed as an alternative to the government monopolies we currently have, which alleged free marketers are so in favour of. Dean Baker has written some stuff on it; http://prospect.org/cs/articles?article=patent_medicine has an overview of and argument for the approach.
One of the things that Indian law got right was its older patent law on drugs. The way it used to work was this: you could patent the process of making a particular drug, not the chemical composition of the drug itself. If you could build the same or a better product for cheap using a different process, good for you, and good for everybody else. In most other fields that would be called innovation and good entrepreneurship. I think the main if not the principal point of IP laws is to encourage innovation, technological advance and entrepreneurship.
Unfortunately the older market leveling laws rub a significantly large class of free-market proponents the wrong way, at least the most vocal and politically relevant ones.
But back to the laws, a popular counterargument has been that the existing laws encourage research whereas the older ones did not. I used to be sold on that line of reasoning till my exposure to the conduct of drug development and research. In US they are almost always always government funded.
The counterargument is that if a company is the first to discover that a given molecule is useful medically, and is safe in humans, then they should get exclusive rights to sell that molecule for some time. This makes sense because it is atrociously expensive to get to that point, and the idea that another company should be allowed to manufacture and sell that same molecule after all the hard work has been done by subbing in different chemical reactions to get there is sort of silly.
EDIT: Didn't see the last line there. Are you sure that the vast majority are govt. funded all the way to the end of clinical trials? This doesn't jive with what I've heard.
[+] [-] maxharris|15 years ago|reply
Suppose that a new regulation passed that eliminated off-label prescriptions. Many will agree that the suffering and death that would result would be immense. (Just ask anyone who has a friend or relative that's benefited from an off-label drug.) Yet off-label prescriptions fly in the face of what the FDA does. What's going on here?
What we choose to do when we're sick ultimately rests on each of us, individually. We all need to be free to do the research ourselves or to delegate this responsibility to whomever each of us has trust in (a particular doctor, for example). The inevitable consequence of losing this freedom is that far more of us suffer and die today than would otherwise.
The valid function of the FDA (valid insofar as it is a source of scientific information) should be performed by a private organization like Consumer Reports, which has a great deal of authority, but is completely independent of both companies and the government. Consumer Reports doesn't use violence or the threat of violence to back itself up: the one thing that keeps it in business is trust.
Certainly, Consumer Reports doesn't offer its products or services for gratis. But many people find the service valuable enough to pay, and with our bodies, the stakes are much higher. Most people will pay for such a drug-vetting service, either directly or through the professional they delegate health decisions to.
We all want safe drugs, and the market is capable of producing and selling safe drugs to us. All we need is to be left free (meaning that the government does one thing only: prevent force and fraud), and verification organizations that pride themselves on true independence will arise.
^This right over your own body really is absolute (so long as you're not hurting someone else). I don't use or advocate for the use of illegal drugs, but it really is no one's business but your own. Yaron Brook recently summed it up best when he said, "You know you're in trouble when you declare war on inanimate objects."
[+] [-] ramanujan|15 years ago|reply
www.youtube.com/watch?v=YI-m2Cucdoo
His stated rationale is that increased FDA regulation against startups will help the"traditional manufacturers". No, really. Watch the whole thing.
[+] [-] barrkel|15 years ago|reply
To the downvoters out there: if you're serious about this problem, you need to live in the real world. That would be more productive.
[+] [-] jpulgarin|15 years ago|reply
[+] [-] alnayyir|15 years ago|reply
A few points:
1. Consumer Reports messes up, your dishwasher might break down before the end of the warranty.
2. A drug company messes up, hundreds, potentially thousands die or have their lifespans severely curtailed in terms of quality of life or length.
That's the last I'll say on it, the magnitude of what's at stake should be otherwise self-evident.
[+] [-] reader5000|15 years ago|reply
[+] [-] barrkel|15 years ago|reply
[+] [-] bigwally|15 years ago|reply
[+] [-] srean|15 years ago|reply
Unfortunately the older market leveling laws rub a significantly large class of free-market proponents the wrong way, at least the most vocal and politically relevant ones.
But back to the laws, a popular counterargument has been that the existing laws encourage research whereas the older ones did not. I used to be sold on that line of reasoning till my exposure to the conduct of drug development and research. In US they are almost always always government funded.
[+] [-] ericd|15 years ago|reply
EDIT: Didn't see the last line there. Are you sure that the vast majority are govt. funded all the way to the end of clinical trials? This doesn't jive with what I've heard.
[+] [-] eekfuh|15 years ago|reply
I now have to purchase Ventolin, which is no different medication wise, just the inhaler is different.
[+] [-] kujawa|15 years ago|reply
Not that I'm bitter or anything.
Not that I would ever suggest that the EPA and environmentalists prefer their CFC purity to be 100% at the expense of asthmatics.
[+] [-] chime|15 years ago|reply
[+] [-] Symmetry|15 years ago|reply
[+] [-] ck2|15 years ago|reply