A better article on this story includes this quotation: "Zhang says it could take 25 years between clinical trials and other steps before her research is helping patients." To prevent a jillion people from dying while awaiting treatment, maybe someone could bankroll a $100K "Bring a Product to Market in Less Than 25 Years" science competition.
And in 15 years we would have a similar post on the internet about how someone should bankroll a competition that increases the safety of these drugs that are flooding the market with heinous side effects.
Clinical trials take so long because there are so many regulations about safety. You can argue that cancer patients are going to die anyway, so let them decide to take whatever drugs they want. On the other hand, this opens the most vulnerable people up to those that have the most to gain from exploiting them.
There is a lot of red tape involved in getting a medical drug to market, but a lot of it is there for good reason.
>Clinical trials take so long because there are so many regulations about safety.
Clinical trials take so long because it takes so long to perform the study. Clinical trials cost so much because of regulations, and because of sparing no expense to make them happen more quickly.
Eh, I'm not sure that is a distinction you can really separate. The regulations require five phases of progressively more difficult requirements, full double-blind trials, etc. Do you really think companies are going to take the time to do proper, five phase trials if it wasn't required?
Yeah there are a lot of phases, but each phase takes a while. (Though the first couple phases, which are mostly about ensuring that the drug isn't poisonous, don't take too long.) Clinical work has to move at the speed of biology, which is very slow compared to computers. Skin cells, which have a really short life cycle, divide every 15 days. For a disease like cancer, if even a handful of cancerous cells hasn't been destroyed, you could experience a relapse--but it would take a while, perhaps even years, for the cancer to build back up to detectable levels. If your disease takes years to confirm that it's gone, the clinical trial is going to take years to confirm that it works. It really sucks, but that's just how biology works.
Exactly, which was my point to the original parent. =)
Biology is slow, so effective and scientifically accurate trials are slow. These slow trials are required because of regulations for health and safety reasons, which means time to market is slow for drugs.
Which means complaining about the 25 year time to market (the original parent's comment) is really the same as complaining about regulations. Drop the regulations and companies are no longer required to do scientifically accurate/responsible studies, which means faster to-market times (and less safe drugs).
25 years is a worst-case situation, where it turns out that this particular method doesn't actually help much.
But when you're dealing with biology, and particularly human biology, you are subject to iterating at the speed of the biology. Depending on the type of cancer, accruing enough people so that you can actually determine efficacy and then waiting to see how the people do on the treatment can take easily 5 years, perhaps 15.
And while a huge number of treatments look promising at this stage of development, the vast majority end up not being effective. The chances of success, amount of effort, and potential monetary payoff to the basic researchers, are all less favorable than a startup.
http://www.signonsandiego.com/news/2011/dec/05/calif-teen-ta...