Gerald
06-09-18, 09:08 AM
Dr. Scott Gottlieb, the commissioner of the Food and Drug Administration, recently vowed to bring “new science” to market faster, in hopes that patients benefit from treatment advances sooner.
Medications are already clearing regulatory hurdles faster than ever, but it’s not clear that people, as opposed to drug companies, are feeling much benefit. For several years the F.D.A. has been lowering the standards by which it decides whether new medications are safe and useful. The agency now requires fewer and smaller clinical trials, approving some drugs after just one successful trial. It also accepts short-term effects (like whether a drug shrinks a tumor) instead of clear clinical outcomes (like whether the drug prolongs life), and ever-smaller improvements in health as sufficient proof that a medication works and is worth selling.
https://www.nytimes.com/2018/06/08/opinion/drug-approval-cutting-prices.html
Not easy to create a market that, to a large extent, just wants more money at the expense of its customers.
Medications are already clearing regulatory hurdles faster than ever, but it’s not clear that people, as opposed to drug companies, are feeling much benefit. For several years the F.D.A. has been lowering the standards by which it decides whether new medications are safe and useful. The agency now requires fewer and smaller clinical trials, approving some drugs after just one successful trial. It also accepts short-term effects (like whether a drug shrinks a tumor) instead of clear clinical outcomes (like whether the drug prolongs life), and ever-smaller improvements in health as sufficient proof that a medication works and is worth selling.
https://www.nytimes.com/2018/06/08/opinion/drug-approval-cutting-prices.html
Not easy to create a market that, to a large extent, just wants more money at the expense of its customers.