One of the very very very important (I cannot emphasize enough) and brilliant essays of this year - here:
I thus believe that any predictions about the future of medicine have to include what I call the “space program factor” (SPF). By this I mean simply that progress in the space program would have proceeded far, far faster (and thus approximated more closely what was theoretically possible) if it were not a high-visibility project with lots of political and social overtones which make it fault-intolerant — if you could burn up as many astronauts as you do test pilots every month, it would cost a lot less to get where you’re going. First-shot fail-safe engineering is costly. Medicine suffers from the same kinds of problems — witness the FDA as both the solution and the problem.
Similarly, psychiatric drugs (which are typically chronically used) are no longer economical to develop and market because of the litigation costs associated with them. Widespread chronic use of any drug means that the likelihood of adverse conditions that were impossible to detect in the testing phase of the drug development process are almost certain to emerge. Statistics rule in drug development, and a Phase III study that lasts a year and enrolls 5,000 patients is simply not adequately powered to predict what will happen when 5 million patients take a drug for 20 years! The only way to get that data is to do that study. And therein lies a powerful caution about antiaging drugs. These drugs will likely need to be taken starting in young adulthood, or in middle age, at latest, and they will need to be taken for a lifetime. Indeed, if they are effective, for a longer lifetime than any but a few super-centenarians has previously lived.
Finally, while Geoff cites this putative advance in antiviral drug therapy, the fact is that my prediction about a plethora of new and highly effective targeted molecular antimicrobials by 2008 was WRONG. In fact, antibiotic research is all but dead, and there are virtually no fundamentally new antibiotics in the drug pipeline. This should scare the crap out of all us, because we are rapidly approaching complete antibiotic resistance with a number of common and highly lethal bugs, including staph (MRSA), streptococcus, E. coli, pseudomonas and candida. It is only a matter of months to a few years, at most, before completely antibiotic resistance staph and streptococcus emerge. Pharmaceutical companies have a large negative incentive for developing new antimicrobials. At the cost of over a billion dollars a new drug (regulatory) and the high risk of withdrawal of the drug within 5 years (2 out of 3), as well as the near certainty of punishing litigation for adverse effects, antibiotics are not merely uneconomical to develop, they are fiscal suicide. Only drugs that will be chronically used by very large numbers of patients are now worth developing.
Keep believing in the "power" of invisible hand and have a good day.
I thus believe that any predictions about the future of medicine have to include what I call the “space program factor” (SPF). By this I mean simply that progress in the space program would have proceeded far, far faster (and thus approximated more closely what was theoretically possible) if it were not a high-visibility project with lots of political and social overtones which make it fault-intolerant — if you could burn up as many astronauts as you do test pilots every month, it would cost a lot less to get where you’re going. First-shot fail-safe engineering is costly. Medicine suffers from the same kinds of problems — witness the FDA as both the solution and the problem.
Similarly, psychiatric drugs (which are typically chronically used) are no longer economical to develop and market because of the litigation costs associated with them. Widespread chronic use of any drug means that the likelihood of adverse conditions that were impossible to detect in the testing phase of the drug development process are almost certain to emerge. Statistics rule in drug development, and a Phase III study that lasts a year and enrolls 5,000 patients is simply not adequately powered to predict what will happen when 5 million patients take a drug for 20 years! The only way to get that data is to do that study. And therein lies a powerful caution about antiaging drugs. These drugs will likely need to be taken starting in young adulthood, or in middle age, at latest, and they will need to be taken for a lifetime. Indeed, if they are effective, for a longer lifetime than any but a few super-centenarians has previously lived.
Finally, while Geoff cites this putative advance in antiviral drug therapy, the fact is that my prediction about a plethora of new and highly effective targeted molecular antimicrobials by 2008 was WRONG. In fact, antibiotic research is all but dead, and there are virtually no fundamentally new antibiotics in the drug pipeline. This should scare the crap out of all us, because we are rapidly approaching complete antibiotic resistance with a number of common and highly lethal bugs, including staph (MRSA), streptococcus, E. coli, pseudomonas and candida. It is only a matter of months to a few years, at most, before completely antibiotic resistance staph and streptococcus emerge. Pharmaceutical companies have a large negative incentive for developing new antimicrobials. At the cost of over a billion dollars a new drug (regulatory) and the high risk of withdrawal of the drug within 5 years (2 out of 3), as well as the near certainty of punishing litigation for adverse effects, antibiotics are not merely uneconomical to develop, they are fiscal suicide. Only drugs that will be chronically used by very large numbers of patients are now worth developing.
Keep believing in the "power" of invisible hand and have a good day.
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