3 ms·

Yes. There was the other article sitting around recently asking why the rate of blockbuster drugs have slowed down. Getting even the level of confidence require

Yes. There was the other article sitting around recently asking why the rate of blockbuster drugs have slowed down. Getting even the level of confidence required now is hugely expensive. Requiring higher confidence is an expensive choice that must be weighed closely. I think it's becoming clearer each day that many drug side effects, and general drug efficacy is effected by the genetics of the drug taker. Without being able to tease out these genetic effects, blindly aiming for broad population safety or efficacy levels is always going to be troublesome. This is separate from the data publication issue that the article focuses on.

tommorris 12y ago
> There was the other article sitting around recently asking why the rate of blockbuster drugs have slowed down. Getting even the level of confidence required now is hugely expensive. Requiring higher confidence is an expensive choice that must be weighed closely. Not just expensive but also potentially unethical. Consider this: post-exposure prophylaxis for HIV. It's used both for sexual and non-sexual exposure to the HIV virus. It's a month-long series of antiretrovirals (the exact protocols used differ). It's effective if you start taking it within 72 hours of exposure. The drugs themselves have been tested for use by people who are HIV+, but nobody has done clinical trials on using them as post-exposure prophylaxis. We know it works, but we don't know how well because testing would be unethical. You'd have to take half the people who are exposed and give them placebo and put them at risk of getting HIV. At a certain point, you have to throw the dice and say "given the evidence we have, this is what we are going to do". (The fact that such judgement calls are being distorted by evidence being intentionally withheld by drug companies is disgraceful though.)
bainsfather 12y ago
"Requiring higher confidence is an expensive choice that must be weighed closely." Confidence of effectiveness is very easy to get - you just need to find an effective drug. e.g. when antibiotics were first tried - they are massively effective compared to previous treatments - you get high confidence of effectiveness from just a small sample size. A reason it is hard for new drugs to get high confidence is because they are only marginally better than existing drugs.
fluidcruft 12y ago
What is a "blockbuster" drug? One that makes a lot of money for the various stakeholders or one that has a large impact on human health? I'm not sure I care too much about the former and it's not at all obvious how "level of confidence" would affect the latter. Yes, as a result of past medical progress it is more difficult to improve upon the current state of the art. But new therapies have to compete with existing therapies in the market anyway. If a new therapy can't outperform existing ones, what actual value does it have? Perhaps drug companies should think about solving problems that aren't already solved rather than bemoaning their inability to reap massive profits while reinventing the wheel or pushing minor formulation tweaks to renew their patents.

tommorris 12y ago

> There was the other article sitting around recently asking why the rate of blockbuster drugs have slowed down. Getting even the level of confidence required now is hugely expensive. Requiring higher confidence is an expensive choice that must be weighed closely. Not just expensive but also potentially unethical. Consider this: post-exposure prophylaxis for HIV. It's used both for sexual and non-sexual exposure to the HIV virus. It's a month-long series of antiretrovirals (the exact protocols used differ). It's effective if you start taking it within 72 hours of exposure. The drugs themselves have been tested for use by people who are HIV+, but nobody has done clinical trials on using them as post-exposure prophylaxis. We know it works, but we don't know how well because testing would be unethical. You'd have to take half the people who are exposed and give them placebo and put them at risk of getting HIV. At a certain point, you have to throw the dice and say "given the evidence we have, this is what we are going to do". (The fact that such judgement calls are being distorted by evidence being intentionally withheld by drug companies is disgraceful though.)

bainsfather 12y ago

"Requiring higher confidence is an expensive choice that must be weighed closely." Confidence of effectiveness is very easy to get - you just need to find an effective drug. e.g. when antibiotics were first tried - they are massively effective compared to previous treatments - you get high confidence of effectiveness from just a small sample size. A reason it is hard for new drugs to get high confidence is because they are only marginally better than existing drugs.

fluidcruft 12y ago

What is a "blockbuster" drug? One that makes a lot of money for the various stakeholders or one that has a large impact on human health? I'm not sure I care too much about the former and it's not at all obvious how "level of confidence" would affect the latter. Yes, as a result of past medical progress it is more difficult to improve upon the current state of the art. But new therapies have to compete with existing therapies in the market anyway. If a new therapy can't outperform existing ones, what actual value does it have? Perhaps drug companies should think about solving problems that aren't already solved rather than bemoaning their inability to reap massive profits while reinventing the wheel or pushing minor formulation tweaks to renew their patents.