[Ip-health] Stat News: WHO director issues thinly veiled rebuke of FDA critics

Thiru Balasubramaniam thiru at keionline.org
Sun Feb 12 22:53:28 PST 2017



WHO director issues thinly veiled rebuke of FDA critics

By HELEN BRANSWELL @HelenBranswell

FEBRUARY 9, 2017

The director of the World Health Organization issued a thinly veiled rebuke
of critics suggesting that the Food and Drug Administration should be
overhauled, including several candidates reported to be in consideration to
head the agency.

Speaking at a conference in Seattle on Wednesday, Dr. Margaret Chan warned
against loosening the rules governing the safety and effectiveness data
that drug companies must supply to win marketing approval from the FDA.

“We must not let anything, including economic arguments or industry
pressure, lower our scientific standards or compromise our integrity. This
is an absolute duty,” Chan said in a speech at the University of
Washington. Her remarks were circulated by the WHO on Thursday.

The highest standards of scientific integrity must be applied, Chan
insisted, warning that politicians, the pharmaceutical industry, and the
public must not “forget the lessons of the thalidomide disaster.”

Trump wants to blow up the FDA. The drug industry? Not so much

The drug, used to combat the morning sickness that sometimes accompanies
pregnancy, caused catastrophic birth defects in children born to women who
used it in the late 1950s and early 1960s.

At the time, far less safety and efficacy data were required to bring a
drug to market in the US. Despite that, the FDA did not approve the drug.
However, more than 10,000 children from 46 countries were affected.

In the wake of the thalidomide episode, Congress approved the Kefauver
Harris Amendment, a 1962 amendment to the Federal Food, Drug, and Cosmetic
Act. It required drug companies to provide proof of the effectiveness and
safety of their drugs in order to gain approval.

“Regulatory agencies everywhere must resist the push to replace randomized
clinical trials, long the gold standard for approving new drugs, with
research summaries provided by pharmaceutical companies,” Chan said in her

“As some argue, making this change would speed up regulatory approval,
lower the costs to industry, and get more products on the market sooner.
This kind of thinking is extremely dangerous.”

At least two of the rumored candidates for FDA commissioner have advanced
nontraditional views on how the regulatory agency should approve drugs.

Jim O’Neill, a staunch libertarian who is not a physician, has called for
discarding the requirement that new medicines be shown to be effective
before they are given FDA approval. O’Neill has suggested undue regulation
by the FDA “kills people” and hurts the economy.

He has also suggested the FDA should only require pharmaceutical companies
to prove that a drug is safe before clearing its way to the market.

Another reported candidate, Dr. Joseph Gulfo, has dismissed that idea as a
way to sell “safe snake oil.”

But Gulfo has argued the FDA should adopt a tiered approval system that
would allow some drugs to make it to market even if they haven’t shown that
they change the long-term health outcomes of people taking them.

Gulfo, who is currently executive director of the Lewis Center for
Healthcare Innovation and Technology at Fairleigh Dickinson University,
suggests the regulatory agency should consider whether drugs lead to
positive trends in biomarkers linked to diseases.

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