s****e
发帖数: 5429 | 1 【 以下文字转载自 USANews 讨论区 】
发信人: wonderment (wonder), 信区: USANews
标 题: Re: 这是疯了吧？！川普称「没必要证明新药有效」（转载）
发信站: BBS 未名空间站 (Tue Feb 7 15:09:56 2017, 美东)
NY Times 的报道，左逼媒体，你可以不信。
不过貌似这样说的是川普选的 FDA 新领导人，他本人说的是危重病人的药不需要（过
多）审查。而这位新科 FDA 一把手确实说过制药公司把药推向市场前不需要证明药物
有效
“Mr. O’Neill has argued that companies should not have to prove that their
drugs work in clinical trials before selling them to consumers.”
Trump’s F.D.A. Pick Could Undo Decades of Drug Safeguards
By KATIE THOMASFEB. 5, 2017
President Trump during a meeting with top drug executives at the White House
last week. Credit Stephen Crowley/The New York Times
President Trump’s vow to overhaul the Food and Drug Administration could
bring major changes in policy, including steps to accelerate the process of
approving new prescription drugs, setting up a clash with critics who say
his push for deregulation might put consumers at risk.
Mr. Trump has been vetting candidates to run the agency, which regulates the
safety of everything from drugs and medical devices to food and cosmetics.
Among them is Jim O’Neill, a former official at the Health and Human
Services Department who is an associate of the Silicon Valley billionaire
and Trump supporter Peter Thiel. Mr. O’Neill has argued that companies
should not have to prove that their drugs work in clinical trials before
selling them to consumers.
Other candidates also have called for reducing regulatory hurdles.
If the most significant proposals are adopted — and many would require an
act of Congress — they will reverse decades of policy and consumer
protections dating to the 1960s. Congress toughened the drug approval
process in the wake of the worldwide crisis over thalidomide, which caused
severe birth defects in babies whose mothers had taken the drug in pregnancy
. Since then, the F.D.A. has come to be viewed as the world’s leading
watchdog for protecting the safety of food and drugs, a gold standard whose
lead other countries often follow.
Mr. Trump’s most recent statements, made at a White House round-table
discussion last week with leaders of the nation’s top drug companies, have
reverberated throughout the medical and pharmaceutical industries.
Supporters of deregulation have long wanted to reduce bureaucracy and lessen
oversight of drugs and devices, while critics say the market for drugs
could be destabilized and the door opened to unproven products based on junk
science.
Continue reading the main story
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Continue reading the main story
“Everyone depends on the agency, from the drugs in our medicine cabinet to
the food on our dinner table, to our blood supplies,” said Dr. David
Kessler, who was commissioner of the F.D.A. during the presidencies of the
elder George Bush and Bill Clinton. “We are the envy of the world because
our honey is our honey. Our foods are not laced with pesticides. Our drugs
work.”
Mr. Trump said at the meeting that he was close to naming a “fantastic”
person to lead the agency. In addition to Mr. O’Neill, candidates whose
names have recently surfaced include Dr. Scott Gottlieb, a former F.D.A.
official with longstanding ties to pharmaceutical and biotech companies, and
Dr. Joseph Gulfo, a former biotech and medical device executive.
All three have called for streamlining the drug approval process, but Mr. O
’Neill’s stance has drawn the most attention. He is a managing director of
Mithril Capital Management, an investment firm Mr. Thiel co-founded, and
previously led the Thiel Foundation, Mr. Thiel’s philanthropic organization
. During the George W. Bush administration, Mr. O’Neill held a series of
roles in the Health and Human Services Department, including as principal
associate deputy secretary, where he worked on policy, including for the F.D
.A., according to his LinkedIn profile.
Mr. O’Neill is a libertarian who is on the board of the SENS Research
Foundation, a charity that funds anti-aging research, and until recently
served on the board of the Seasteading Institute, an effort to create new
societies at sea.
At an anti-aging conference in 2014, Mr. O’Neill advocated something he
called “progressive” approval, in which drugs that were proved safe, but
not yet proven effective, could be allowed on the market. “Let people start
using them, at their own risk,” Mr. O’Neill said. “Let’s prove efficacy
after they’ve been legalized.”
Companies have been required to prove that their drugs work since 1962, when
Congress passed legislation requiring that licensing for sale be based not
just on safety but also on “substantial evidence” of a drug’s efficacy.
That law, and others passed since, forced companies to rigorously test their
products, running them through a gantlet of clinical trials whose results
are then vetted by the F.D.A. before any sales to consumers. Ninety percent
of drugs that enter clinical development fail these trials. (The F.D.A. also
regulates medical devices, but they undergo a separate approval process.)
As a result, newly discovered drugs can take years to reach the market, a
period that Mr. Trump said last week was too lengthy.
“When you have a drug, you can actually get it approved if it works,
instead of waiting for many, many years,” he told the pharmaceutical
executives. “We’re going to be cutting regulations at a level that nobody
’s ever seen before, and we’re going to have tremendous protection for the
people.”
Photo
Jim O’Neill, one of the candidates to run the Food and Drug Administration,
at Trump Tower last month. His stance on streamlining the drug approval
process has drawn the most attention. Credit Drew Angerer/Getty Images
Some have suggested that a commissioner determined to weaken the efficacy
standard need not seek congressional action, but could interpret existing
regulations loosely so that requirements for certain clinical trials —
particularly the costly, large-scale ones that can take years and involve
thousands of patients — can be rolled back.
That could have serious implications for patients. Last month, the F.D.A.
released a study of 22 drugs that appeared promising in early studies but
failed in final, large-scale trials. Drug safety watchdogs point to examples
like the painkiller Vioxx, which was withdrawn from the market in 2004 over
safety concerns, as proof of the high stakes involved in drug approval.
While Mr. Trump’s call to cut regulations has been warmly received by other
industries, some biotech executives have reacted to his remarks with alarm.
Those affiliated with some smaller companies have privately described the
choice of Mr. O’Neill as a worst-case scenario that could send the drug
industry into chaos. The F.D.A., they say, is not perfect, but its standards
provide a level playing field on which both big and small companies can
compete.
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“We’re not selling Coca-Cola and Pepsi, where patients can taste the Coca-
Cola and decide if they like it,” said John M. Maraganore, the chief
executive of Alnylam Pharmaceuticals, a Massachusetts biotech firm. “Our
products are lifesaving medicines.”
Industry executives said big changes to the agency would also be bad for
business, making it difficult for companies with breakthrough treatments to
distinguish their products from those that are shams. If standards at the F.
D.A. are rolled back, “then we might as well be advertising in the middle
of the night on how terrifically we can cure all your illnesses,” said Dr.
Leonard S. Schleifer, the chief executive of Regeneron, a pharmaceutical
company in Tarrytown, N.Y. “That’s not the business that I think most of
us want to be in.”
Daniel Carpenter, a professor at Harvard University who studies the F.D.A.,
said its role is not just to ensure the safety of a drug. “The
underpinnings of belief among patients, payers, even investors, is that
somebody out there has tested these things and has shown, with some evidence
, that they work,” he said.
Mr. O’Neill did not respond to emails and a phone call requesting comment,
and Dr. Gottlieb declined to comment.
Dr. Gulfo, the former biotech executive, said he had spoken with several
people on the president’s transition team about the F.D.A. job. He said he
was in favor of keeping the efficacy requirement. But he said he believed
the agency’s standards were too rigid and burdensome to companies with
innovative ideas. He called on the agency to approve more drugs based on
what are known as “surrogate endpoints” — showing that a diabetes drug
lowers blood sugar, for example — rather than forcing companies to prove
that the product improves long-term outcomes like survival rates or lowering
the chance for heart attacks.
“Let’s bring the F.D.A. back to what its mission is, and its mission is to
make sure that drugs can be labeled for safe use, and that they’re not
snake oil,” said Dr. Gulfo, the former chief executive of MELA Sciences,
who wrote a book about his company’s failed efforts to get its skin cancer
detection device approved. (The agency eventually approved it for use in
2011.)
Several drug company executives said the F.D.A., while not perfect, had sped
up the approval process in recent years and had been responsive to requests
to approve drugs based on interim measurements, particularly for life-
threatening diseases that have no other treatments. The agency sets a 10-
month goal for approving standard drugs, and a six-month period for those
that have qualified for expedited approval; one recent study showed it
decides on drugs more quickly than its counterparts in Europe and Canada.
A majority of recent new drugs were approved through expedited approvals,
another recent study found. In December, Congress passed a law that further
speeds approvals for certain drugs and medical devices.
Drug industry leaders say that they want the F.D.A. to be more open to
allowing new kinds of clinical trials, and that it needs to become more
nimble in keeping up with the breathtaking pace of medical advances. They
have also been prodding the agency to fill an estimated 1,000 staff
vacancies so that decisions can be made more quickly. But that is apparently
delayed because the president ordered an across-the-board hiring freeze.
“The only way you would make it shorter is you staff up,” said Michael
Gilman, an entrepreneur who has founded several biotech companies. “You
certainly don’t do it by slashing staff. So the logic of the whole thing
doesn’t compute for me.” | s****e
发帖数: 5429 | | b*****2
发帖数: 11103 | | x********e
发帖数: 35261 | 4 我本科时上过制药和FDA审批的课。记不太清了，不过大意是，上真人实验要跟踪好几
年，然后还可能因为各种副作用被毙。你想想万分之一的副作用要坐多久的实验才能看
出来。
【在 s****e 的大作中提到】
: 术版讨论一下，这对药厂和生物千老是利好吧
| i****a
发帖数: 36252 | 5 会不会吃了新药不死了，但变成科学怪人。医生和药广赔大钱，打工仔买单。
【在 b*****2 的大作中提到】
: 这是对的，都快死球了，还讲究吃啥药
| m***y
发帖数: 14763 | 6 是啊，标明未经临床测试，必须有医生处方，也就够了。
医生解释清了还要吃的，责任自负。
【在 b*****2 的大作中提到】
: 这是对的，都快死球了，还讲究吃啥药
| M****u
发帖数: 17708 | 7 吃这个，肯定有一堆paperwork要签，吃死算球。
【在 m***y 的大作中提到】
: 是啊，标明未经临床测试，必须有医生处方，也就够了。
: 医生解释清了还要吃的，责任自负。
| d********f
发帖数: 43471 | 8 重大利空，药厂nih一年大概投入10b以上作脱裤子放屁的统计，现在不需要了的话，那
基本上几万千老下岗
【在 s****e 的大作中提到】
: 术版讨论一下，这对药厂和生物千老是利好吧
| b*****n
发帖数: 17570 | | a***e
发帖数: 27968 | 10 根本不可能
门槛高是药厂赚钱的保证
换个总统再变一次谁都受不了
★ 发自iPhone App: ChineseWeb 13
【在 d********f 的大作中提到】
: 重大利空，药厂nih一年大概投入10b以上作脱裤子放屁的统计，现在不需要了的话，那
: 基本上几万千老下岗
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