On the 100x Price Rise of a Formerly Generic Drug
pipeline.corante.com
pipeline.corante.com
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."
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.
Thanks for posting this!
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.
America was founded as a republic limited by a constitution, and it existed that way for a long time. It wasn't an unachieved pie-in-the-sky wonderland (nor was it perfect: I think the civil war was a just and necessary war).
You can make this world better. It's just a matter of understanding things well enough to argue rationally for the right thing. After all, how did the Rennaisance happen, or the American revolution? The people that lived then were just like you and I in this respect, and they didn't even have the benefit of the Internet to communicate.
Or could it be that there really is something to these ideas? There is a strong intellectual foundation here, and while the novel you mentioned describes much of it, a much fuller explanation can be found in her nonfiction work.
As an intellectual movement, we're gaining steam. Here's a recording of a debate held in NY between Yaron Brook (aynrand.org) and Miles Rapoport (demos.org) just five days ago: http://www.archive.org/details/FirstPrinciples-Government_Wh...
Here's a link to the debate site (WNYC is New York public radio): http://www.wnyc.org/articles/its-free-country/2011/mar/02/de...
Right now, most people don't agree, but when they hear these ideas out out, they do realize that they constitute a respectable argument (and one that they haven't heard before).
Twenty years from now, our ideas will be mainstream in the sense that most people will have heard them and have some idea of what they are (and how they're different from conservativism and libertarianism). Obviously, people will never agree with everything that anyone has to say, but that isn't the point. The point is to get people to think about this stuff in a productive way. The more people that do that, the better.
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.
Human life is so important, and the needs of each individual body are frequently so diverse from one another, that we can't trust decisions like these to a one-size-fits-all regulatory body.
This is yet another case where ethics and politics is a life-and-death matter (and for more people than you'd ever care to think about).
But I think that we can make a difference against ignorance, just by speaking up. In years past, I used to make the mistake of just being quiet when political or moral topics came up, just because I didn't think it would be of any use.
I don't think that's true any longer because I realized that if you can state your case clearly enough, and it's a rational position, at least some people will listen. You don't have to immediately convince everyone, or even the majority of people. Just making the correct argument shifts the debate toward a better direction, and that's a powerful thing.
That dramatizes opportunity cost.
http://www.cbsnews.com/stories/2010/12/29/60minutes/main7195...
Immoral businesses love regulations because they provide huge barriers to entry for new competitors. Observe how GSK uses the FDA and other regulatory agencies to shield themselves. From the article you linked:
"GSK's manufacturing division has a strong track record of quality and compliance with current Good Manufacturing Practice (cGMP) requirements. Various regulatory agencies - including the FDA - conduct an average of more than 100 inspections each year at over 80 GSK manufacturing sites located in over 30 countries. The FDA has raised no material issues as a result of its very thorough inspections. ... GSK worked to bring the Cidra facility to a high level of operating performance that satisfied both GSK and the FDA."
We need to separate the state from economics, just like we separate it from church. Unscrupulous companies (not all of them are this way) use and promote regulations to keep their competitors down, and to escape legal reprecussions that they should properly face (just as your article demonstrates). Remember that Enron lobbied for strict price controls on rates charged for access to power grids. (http://www.theatlantic.com/past/docs/issues/2002/04/orourke....)
That does not exist in the USA for ANY kind of industry, it's the nutshell of the problem for our entire country.
Your proposal would kill the last ounce of innovation that hasn't been already crushed by the vast number of regulations already in place.
When someone is injured or their property is damaged, that's what civil courts are for. When someone is killed intentionally, or by many instances of negligence, we have criminal courts to see that justice is done. All we need is to eliminate the regulations that people (and groups of people) hide behind and let the appropriate court do its job. And in some instances, bad precedent has to be overturned. At any rate, this is a much better idea than legislating and regulating more (which is like trying to dig your way out of a hole.)
[1] http://www.cbsnews.com/stories/2003/06/03/health/main556653....
In this case, it's up to a court to decide if people knew enough about HIV in 1984 and 1985 to make the right call. HIV had only been discovered in 1983, and that very little was known about it at the time. It's easy to look at this in hindsight and think badly of them, with everything we've since learned about it, but that's not the standard by which they must be judged because omniscience cannot be the standard of knowledge by which we judge anyone.
Putting people in jail outside of this context (e.g., when there isn't any evidence that they've done anything wrong) kills innovation because it severely punishes any risk-taking (which is another word for innovation).
A corporation is only a group of individuals. The individuals that constitute a coroporation have rights, and the corporation is simply a legally optimized recognition of those rights.
Remember, rights are negative, in that proper rights can only prohibit one from initiating political force (violence and fraud) against another. Proper rights do not impose obligations on anyone to create anything for anyone else, because that would be a form of slavery.
No sensible person has ever claimed that a corporation is the same thing as a person.
The wikipedia article on corporate personhood might make some illuminating reading: http://en.wikipedia.org/wiki/Corporate_personhood_debate
Unless you already know about it, and are minimizing it for rhetorical reasons. When natural persons break criminal law and go to jail, they are deprived of the product of their labor for a period of time. When a corporation breaks the law, whether you want to attribute that to "evil employees" or to an internal incentive structure which encourages profits above legality, some analogue of jailtime makes sense.
http://www.cbsnews.com/stories/2010/12/29/60minutes/main7195...
Immoral businesses love regulations because they provide huge barriers to entry for new competitors. Observe how GSK uses the FDA and other regulatory agencies to shield themselves. From the article you linked:
"GSK's manufacturing division has a strong track record of quality and compliance with current Good Manufacturing Practice (cGMP) requirements. Various regulatory agencies - including the FDA - conduct an average of more than 100 inspections each year at over 80 GSK manufacturing sites located in over 30 countries. The FDA has raised no material issues as a result of its very thorough inspections. ... GSK worked to bring the Cidra facility to a high level of operating performance that satisfied both GSK and the FDA."
We need to separate the state from economics, just like we separate it from church. Unscrupulous companies (not all of them are this way) use and promote regulations to keep their competitors down, and to escape legal reprecussions that they should properly face (just as your article demonstrates). Remember that Enron lobbied for strict price controls on rates charged for access to power grids. (http://www.theatlantic.com/past/docs/issues/2002/04/orourke....)
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.
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.
Edit: Re govt funding, I have quite a few friends who are in drug research, well, in the capacity of current and ex grad students and spread across 3 universities and a research institute. All of them are fed funded, and they claim that this is generally the rule rather than the exception. In my opinion the privilege of exclusivity should be doled out in proportion to the aggregated (monetary)risks entertained.
Edit2: Don't like threads that nest too deep, so adding here. I would readily concede that I wouldn't have names of drugs at the drop of the hat. My opinions are largely assimilated from my friends working in the area and what I get to read. So hardly the person who would be able to quote stats. Recently an application for extending the period of protection for a anti-retroviral drug was denied in India on the grounds that the molecular change adds nothing to the efficacy of the drug and that the molecular changes in itself do not constitute a non-obvious modification to the chemical to a person of the trade. However, denials of extension like these are very very rare. It is common to keep extending a patent on an old molecule in quantums of decades at a time (Now I wish I had it bookmarked)
However I think your test is stricter than need be. As I said, I am looking for proportionality between risk taken and period of exclusivity. That can be broken even if the govt did not carry the full weight from end to end (the example that you are seeking). Generally it is the research phase that incurs the most uncertainty and the kind of research that targets greater efficiency or cheaper production, not what will get the drug or derivative an extended protection.
In the context of the older Indian scene, it was the govt funded labs that carried out the research, so it made perfect sense that patents be granted on the process and not on the compound. It also makes sense for the govt to be in the business of funding drug research as for many of the diseases the affected demographics are not most lucrative. (Well unless one is of the opinion that such a population is better of dead, not an unheard of opinion on the net) The research scene is still the same but the laws have been changed subject to international pressure.
There is substantial benefit to be had by driving costs down. In the current scheme of things there are very little incentives to do so.
I know that the US government funds a lot of research via the NIH, and I'm familiar with the fuzzy lines between government and private research in some cases (I have relatives who do research for universities but get DARPA funding), but could you cite some examples of the govt. handing exclusivity to the drug companies after NIH did all the research and clinical trials for a drug?
What I was saying is that the initial formulation and vetting of the chemical is the hard part, so that's the part that should be protected, not the relatively trivial manufacturing component.
I now have to purchase Ventolin, which is no different medication wise, just the inhaler is different.
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.