I would disagree that the pharma drug development model hasn't evolved. There are many recent advances that have helped improve drug development (human cells used in pre-clinical screening, more advanced clinical trial design, etc).
What I think has really changed is the cost of failure. The best example I can think of is the discovery of benzodiazepines (the drug class that includes Valium). The first benzodiazepine (chlordiazepoxide, Librium) was discovered in 1957 (we're talking, the FIRST set of pre-clinical tests) and it was on the market in 1960. 3 years from the first tests to market.
Nowadays, you'd be lucky to get to market in 15 years. A great example is Qutenza. The product is nothing more than a patch that contains a very high level of capsaicin (the stuff that makes peppers hot). When you apply it to the skin, it can reduce the pain that sticks around after an attack of shingles. I can't think of a product with fewer safety issues, yet it took 10 YEARS for the company to get FDA approval.
This is due to a combination of increased FDA scrutiny around safety along with a high standard for efficacy (i.e. we don't care if your drug reduces cholesterol, we want you to prove it reduces heart attacks). So in the past, when a smaller, shorter trial was sufficient for FDA approval, you could take a promising drug all the way to the FDA without a lot of expense. Not so anymore.
Comments
I would disagree that the pharma drug development model hasn't evolved. There are many recent advances that have helped improve drug development (human cells used in pre-clinical screening, more advanced clinical trial design, etc).
What I think has really changed is the cost of failure. The best example I can think of is the discovery of benzodiazepines (the drug class that includes Valium). The first benzodiazepine (chlordiazepoxide, Librium) was discovered in 1957 (we're talking, the FIRST set of pre-clinical tests) and it was on the market in 1960. 3 years from the first tests to market.
Nowadays, you'd be lucky to get to market in 15 years. A great example is Qutenza. The product is nothing more than a patch that contains a very high level of capsaicin (the stuff that makes peppers hot). When you apply it to the skin, it can reduce the pain that sticks around after an attack of shingles. I can't think of a product with fewer safety issues, yet it took 10 YEARS for the company to get FDA approval.
This is due to a combination of increased FDA scrutiny around safety along with a high standard for efficacy (i.e. we don't care if your drug reduces cholesterol, we want you to prove it reduces heart attacks). So in the past, when a smaller, shorter trial was sufficient for FDA approval, you could take a promising drug all the way to the FDA without a lot of expense. Not so anymore.