> Alas with the extremely slow state of regulatory changes, many people that could be already saved nowadays using these techniques are just ending up dead.
I think the article touches upon this, but it's a little more nuanced than 'regulatory changes', because with this technique there is no time for informed consent, and doctors understandably want to avoid a situation carrying out this procedure on a patient who then subsequently died but could have survived were another treatment approach taken.
On the one hand many people do end up dying prematurely because they were not able to benefit from the latest medical technology: on the other, but on the other these new technologies may have substantial short and long term side effects that we're not fully aware of yet.
To give you some examples: many medical professionals are now arguing for stronger regulation of antibiotics because a lack of prior regulation has resulted in widespread drug resistance. Ritonavir is a antiretroviral drug used to treat HIV which during clinical trials was very promising, but after being released was found to be polymorphic and convert in-situ to a different structure which was useless (the drug had to be taken off the market and re-formulated). Thalidomide is a classic case of a wonder-drug which subsequently was found to be wholly inappropriate.
I don't think anyone in the medical profession would argue we should deprive people of the most effective treatment - indeed, it is standard practice in a double-blind trial to halt the placebo participants if the drug being tested proves to be overwhelmingly effective, because it would be unethical to continue. However, it takes time, effort, money, and regulation to establish how that treatment works and what side effects it might have.
Unless we change the way drug companies are paid to develop antibiotics introducing any new regulation on the use of antibiotics won't be a good idea. Most have already canned their antibiotic r&d divisions because they can't make any money from new antibiotics since doctors refuse to use new antibiotics as they want to have a 'back-up' in case of resistance. This has created a negative feedback loop where drug companies stop developing new antibiotics since they aren't being used enough and doctors tighten the use of the few new antibiotics that make it through.
That may have been true a decade ago. Sadly there's plenty of money already to be made in treating MRSA, c. difficile, mdr/xdr TB, and (terrifyingly) VRE and VRSA.
New regulations on antibiotics is essential. The thought that it's not a good idea is outside of mainstream and defies basic common sense.
edit: sadly, I disagree with you. Drug resistance can and is driving new r&d because it's killing people. New drugs will probably be more narrow spectrum and lucrative, more due to the difficulty of finding effective compounds rather than any specific intent.
I don't know if there is plenty of money to be made on the development of antibiotics, but I do know that the heads of all the big pharmaceutical companies don't think there is.
More regulation preventing the use of antibiotics won't encourage pharmaceutical companies to invest in this area, only making developing antibiotics more profitable will. This can be done in three way:
1. Encourage use of the new antibiotics so they sell more.
2. Increase the price.
3. Pay the companies directly for developing a new antibiotic (X-Prize-like approach).
My personal opinion is that option 3 is the best way, but right now there is no mechanism for doing this on anything other than a toy-scale. What won't encourage pharmaceutical companies to invest in the development of new antibiotics is to restrict their sales and increase their costs via regulation.
> I think the article touches upon this, but it's a little more nuanced than 'regulatory changes', because with this technique there is no time for informed consent, and doctors understandably want to avoid a situation carrying out this procedure on a patient who then subsequently died but could have survived were another treatment approach taken.
Sure, i don't argue on that. What I mean is that even if their first trial is widely successful (they save 50% of patients instead of the standard 7%), how long will it take and how many trials will be needed for the FDA to recognize this as a new clinical practice? It will be years - and in this period how many persons who could have been saved by this kind of procedure will die? That's what I was referring to.
If we could tell, just from a single trial, whether a particular drug was safe and effective, then it's true that the subsequent FDA trials would be a huge waste of time. Sadly, history has told us time and again that we can't.
>how long will it take and how many trials will be needed for the FDA to recognize this as a new clinical practice? It will be years - and in this period how many persons who could have been saved by this kind of procedure will die?
what prevents doctors from doing it today? Nothing. Like in that case with brain cooled by groceries, doctors seems to be doing it when they can. Other thing is mass-training of doctors for some procedure - that requires that procedure should be developed to some "packaged" level. This is what FDA approval is part of and seems to be a reasonable part.
Are you advocating that medical regulations NOT be based on scientific evidence? Or are you simply saying that the FDA's standards for new procedures are too conservative?
The examples you give sort of prove the point. People remember bad drugs that killed people for decades afterwards. It sells papers, it makes regulations, companies get sued and people lose their jobs. No one notices when people die but could have been saved.
There is strong incentive to be overly conservative, but we should focus on the net deaths - having as few people die as possible.
I think the article touches upon this, but it's a little more nuanced than 'regulatory changes', because with this technique there is no time for informed consent, and doctors understandably want to avoid a situation carrying out this procedure on a patient who then subsequently died but could have survived were another treatment approach taken.
On the one hand many people do end up dying prematurely because they were not able to benefit from the latest medical technology: on the other, but on the other these new technologies may have substantial short and long term side effects that we're not fully aware of yet.
To give you some examples: many medical professionals are now arguing for stronger regulation of antibiotics because a lack of prior regulation has resulted in widespread drug resistance. Ritonavir is a antiretroviral drug used to treat HIV which during clinical trials was very promising, but after being released was found to be polymorphic and convert in-situ to a different structure which was useless (the drug had to be taken off the market and re-formulated). Thalidomide is a classic case of a wonder-drug which subsequently was found to be wholly inappropriate.
I don't think anyone in the medical profession would argue we should deprive people of the most effective treatment - indeed, it is standard practice in a double-blind trial to halt the placebo participants if the drug being tested proves to be overwhelmingly effective, because it would be unethical to continue. However, it takes time, effort, money, and regulation to establish how that treatment works and what side effects it might have.