American Elephants


Desperate Democrats Embarrass Themselves In Another Confirmation Hearing by The Elephant's Child

With the exposure of the Susan Rice story, and the dreadful sarin gas attack in Syria by the Assad administration on his own people other things escape our attention. The confirmation hearings for Dr. Scott Gottlieb who the president has nominated to run the Food and Drug Administration (FDA) didn’t get a lot of notice.

Our very own Seattle Senator Patty Murray and other Democrats devoted the morning to attacking Dr. Gottlieb for his “unprecedented financial entanglements” because he has consulted for various companies and invested in health-care start-ups. (Possibly because that is his area of expertise?) Sheldon Whitehouse suggested “dark money operations,” which is a strange description of financial disclosures available to all on the internet. Bernie Sanders tweeted that it was a “disgrace” to have an FDA commissioner who has taken money from drug companies.

These are the same committee Democrats who attacked Betsy DeVos for not having enough experience in public education, nor experience in government.  Consistency and hypocrisy are ongoing problems for the Democrats.

Dr. Gottlieb not only disclosed all his work in accordance with government rules and will liquidate his investments, he agreed to recuse himself for a year on decisions involving his past interests. He also promised to follow directions from the HHS ethics office and to be an “impartial and independent advocate for the public health.”

Another remarkable ugly charge was that Dr. Gottlieb would not address the opioid crisis because he has worked with companies that produce painkillers. Desperate Democrats, out of power, are having trouble finding believable or even sane talking points.

Dr. Gottlieb has called the opioid crisis “a public emergency on the order of Ebola and Zika” and suggested an “all-of-the-above” strategy that would include creating new painkillers that were less addictive and better patient care. He hopes to increase generic drug competition. He offered a tutorial in how companies exploit the regulatory barriers to competition for their commercial advantage,

He has written about how the FDA can unleash innovation without compromising public safety. Democrats, always confused about the evils of “profit” have forgotten about the immense value of expertise. This is another of President Trump’s outstanding nominees, so of course he should be attacked. It will be good to have someone who understands the needs of patients and their doctors and the pharmaceutical industry in that office.



Schooling the FDA On The Meaning of the First Amendment by The Elephant's Child

_78425952_517716225I’m afraid I’m becoming something of a crank, grumbling constantly about the depredations of bureaucracy. The Food and Drug Administration has believed its powers so encompassing that it can even prohibit drug companies from making true statements about their products unless they are approved by the FDA.

A federal judge has just called this political control a violation of the First Amendment. Once the FDA has approved a new drug for FDA specified uses, physicians often repurpose them in other doses, or for other diseases, or for entirely different patient populations. A drug designed for breast cancer might prove effective against tumors in other parts of the body, or a medicine for adults may prove effective for pediatric care. About one of every five U.S. Prescriptions is for non-FDA approved uses.

In a small miracle, these off-label experiments are legal, and they drive innovation. The artificial conditions that the FDA demands for clinical trials are increasingly divorced from how medicine is practiced, and modern care advances far faster than the FDA’s regulatory molasses. Off-label use is vital for complex conditions like cancer and psychiatric disorders that require trial and error for individual patients, who can’t wait years for the FDA’s blessing.

But the FDA and Justice Department are targeting off-label prescriptions as a threat to their hegemony. Their goal is to force drug makers and physicians to seek FDA approval for every new real-world use, as if it were an entirely new drug. Until recently, drug makers were banned from making off-label claims backed by solid evidence or even from distributing peer-reviewed journal articles.

Prosecutors have also become increasingly aggressive. In 2012 GlaxoSmithKline paid $1 billion for encouraging doctors to use Paxil to treat depression in patients under 18, which research shows helps although the FDA has not endorsed this conclusion. The FDA construes some forms of off-label promotion as crimes, and people are serving jail time.

The nature of a bureaucracy is to grow, prosper, be better rewarded monetarily and extend its reach. Was there ever a bureaucracy that thought that much that they did was unnecessary, and they should probably downsize for the benefit of the taxpayers? I rest my case.

Judge Paul Engelmayer explained to the FDA that if they believed that a different use of a drug gravely undermined the drug approval process, it should have sought review of that decision, not tried to liken distributing information to an assault on their drug-approval authority, and tried to compare it to illegal speech such as blackmail or insider trading. Free speech wins one!

 



This Is Just Not Right! by The Elephant's Child

The Food and Drug Administration (FDA) has decided that 15 year-old girls can purchase the “morning-after” pill over-the-counter without a prescription or without the knowledge of their parents. They remain not old enough to drive, not old enough to decide what they want for lunch, not old enough to get an aspirin for a headache, not old enough to go on a school field trip without an official signed permission slip from their parents, but the “morning after” pill — no problem.  Go figure.

The so-called Sexual Revolution has a lot to answer for.

 



U.S District Court Has Ruled that Stem Cells Are Drugs. by The Elephant's Child

The U.S. District Court in Washington DC has ruled, last Wednesday,  that a person’s own cultured stem cells are drugs subject to regulation by the Food and Drug Administration.

Peter Aldhous from New Scientist, reported:

It’s official: stem cells are drugs. At least, that’s the opinion of the [court]… which has ruled that the Food and Drug Administration (FDA) has the authority to regulate clinics offering controversial stem cell therapies.

Treatments in which stem cells are harvested from bone marrow and injected straight back into the same patient are deemed part of routine medical practice – not regulated by the US government. But if the cells are subjected to more than “minimal manipulation”, the FDA maintains that the therapy becomes a “drug”, which must be specifically approved for use.

The argument, of course, is that the FDA should have no jurisdiction over one’s own cells, versus the argument that the FDA is needed to make sure that everything is pure, sterile,  and to the standards of the FDA. The companies argue that the FDA is trying to tell them how to practice medicine, the FDA claims that stem cells fall within FDA’s jurisdiction as they affect interstate commerce, and the cultured stem cells are drugs.

This interpretation of the interstate commerce clause shows how stretched that one clause has become. The results from regenerative medicine and adult stem cells have been enormously encouraging, and one would like to see it move much faster.

The FDA has a reputation for extreme slowness in approvals for new drugs, unnecessary regulation and too many costly barriers. I am only a bystander and my opinions of no matter, but I distrust government regulation and government bureaucracy, and the current administration.




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