Yesterday, Bloomberg reported
that Donald Trump is considering nominating venture capitalist and
libertarian Jim O’Neill to head the Food and Drug Administration, and
some in the pharmaceutical industry experienced an increasingly strong
sense of nausea.
O’Neill, works at Mithril Capital, the firm founded by Paypal and
Facebook backer Peter Thiel. That alone could normally serve to generate
concerns about conflicts of interest with medical firms he helped to
found. But O'Neill has also argued in the past that the lack of a
functioning free market is the central fact that makes the current U.S.
medical system overly expensive and wasteful. At a conference about
creating new societies on ocean-rigged platforms, he argued that a
better system would not involve government protections, that people
should be able to pay others for organs used in transplants, and that
the current system encourages bad health. “In a free market, you
wouldn’t be forced to subsidize obesity,” he said in 2009.
But the quote that is causing the most unease is one about one of the
FDA’s core missions: regulating drugs. In an August 2014 keynote at the
Rejuvenation Biotechnology conference, O’Neill suggested:
“We should reform FDA so there is approving drugs after their sponsors have demonstrated safety--and let people start using them, at their own
risk, but not much risk of safety. Let’s prove efficacy after they’ve
Former FDA Commissioner Charged In RICO Lawsuit
That quote betrays a lack of understanding of how drug approvals
actually work, or a commitment to rolling back the clock 50 years.
Most drugs are not safe. Instead, their benefits outweigh their
risks. For instance, Iclusig, a drug used to treat a type of blood
cancer, causes blockages in veins and arteries that can be deadly. But
it is approved because the benefit, for cancer patients who have been
failed by other drugs, is big enough that risk is worth taking.
Thank You Mr Herper and Forbes.
Most Drugs Are Not Safe?
Most Psychiatric Drugs Are Not Even Legal.
(there, fixed it for you)
US 18C95 Sec 1958: Murder For Hire
Many biotech entrepreneurs are actually fans of a tough FDA. At the
Forbes Healthcare Summit, pharmaceutical billionaire Leonard Schleifer,
the founder and chief executive of Regeneron Pharmaceuticals, said that
he was against “making it really easy to get your drug approved” at the
Forbes Healthcare Summit last week, before news of that O’Neill was
under consideration leaked.
Schleifer said that he couldn’t compete with companies like Pfizer or
Eli Lilly, which have 10 to 100 times as many salespeople as Regeneron.
But he can compete to get approved first, or to have a better drug that
has more uses that the FDA allows it to advertise based on science.
“Having a high bar is a good thing, in my opinion, because it allows innovators to compete,” (???) Schleifer said.
PDUFA User Fee Archive
Hell of a ticket price to get into the Compete.
And one hell of an incentive to FDA to ALLOW unsafe, clinical trial rigged drugs to get and stay on the market.
Congressional Research Service: The Food And Drug Administration (FDA) Budget: Fact Sheet July 28, 2016
FDA Wants More Money, Claims They Are A 'Bargain'.
PDUFA must go.