The FDA Death Toll And Use Of Off-Label Medications

BY Herschel Smith
1 month, 3 weeks ago

Mises Institute.

The Food and Drug Administration helped turn the coronavirus from a deadly peril into a national catastrophe. Long after foreign nations had been ravaged and many cases had been detected in America, the FDA continued blocking private testing. The FDA continued forcing the nation’s most innovative firms to submit to its command-and-control approach notwithstanding the pandemic. South Korean is in a far better situation dealing with coronavirus, because its government did not preemptively cripple private testing.

One of the clearest lessons from the current pandemic is that nothing has changed at one of the nation’s most powerful regulatory agencies. The FDA is repeating the same mistakes and showing the same arrogance that I chronicled decades ago in articles for the Wall Street Journal, the American Spectator, and other publications.

Dr. David Kessler, who became FDA commissioner in 1990, quickly sought to intimidate the companies that his agency regulates. A laudatory Washington Post article concluded, “What he cannot accomplish with ordinary regulation, Kessler hopes to accomplish with fear.” Kenneth Feather of the FDA’s drug advertising surveillance branch boasted: “We want to say to these companies that you don’t know when or how we’ll strike. We want to eliminate predictability.”

Dr. Kessler’s heavy-handed tactics battered the American medical device industry—one of the nation’s export superstars. An American Electronics Association survey found that “40% [of medical device companies] reduced the number of U.S. employees because of FDA delays, 29% increased their investment in foreign operations, and 22% moved U.S. jobs overseas.” The survey also found that “57% of the firms said the FDA had applied guidance instructions retroactively to some of their submissions,” as Biomedical Market Newsletter reported.

The FDA’s stonewalling of new medical devices was sometimes politically motivated. A 1994 report by the Medical Device Manufacturers Association noted, “It is not unusual for [FDA] reviewers to express the position that excessive requests [for additional information] are made because of a concern or fear about how a particular member or members of Congress will react” to the approval of a new device. Sacrificing lives was a small price to pay for bureaucrats to avoid bothersome interrogatories from Capitol Hill.

[ … ]

Dr. Kessler did not spare the First Amendment in his grab for power, and cancer patients and other seriously ill people suffered as a result. Doctors, hospitals, and researchers often discover after FDA approval that a drug to treat one disease is also effective at treating other diseases. Drug companies have routinely publicized this news, alerting physicians to other possible ways to save lives. American Medical Association vice president Roy Schwarz estimated that “off-label” uses of drugs account for up to 60 percent of all drugs prescribed.

But in 1991 Dr. Kessler prohibited pharmaceutical companies from informing doctors of new uses for approved drugs. He announced that the FDA would enforce the ban with seizures, injunctions, and prosecutions. Though the agency never finalized its proposed regulations, it warned companies that they would face its wrath if they violated the draft proposals. Dr. Kessler, in a speech before the Drug Information Association, said: “I would urge all members of the pharmaceutical industry to take a long and hard look at their promotional practices. I do not expect companies to wait until this guidance becomes final to put their advertising and promotional houses in order.” The question of off-label treatments is becoming a key issue again as doctors search for effective treatments for the COVID-19 coronavirus.

And thus because of a bureaucrat-laden impediment to medical science, the response to Covid-19 has been slow, cumbersome, lumbering, and deadly.

An example of this might be found in a recent article on another treatment for the virus.  Before we get to that, I recalled a few days ago before seeing this next article that a doctor friend of mine who volunteered in Haiti, found that he had nothing to treat the children who had scabies.  He had to let them suffer because he was sent without medications for that.  If he had been sent with it, he could have used Ivermectin to treat Scabies in humans.

I also recalled that I had treated my dog, Heidi, with Ivermectin once for a parasite, and was warned by the Vet that it was “off-label.”  In this case, off-label meant that it was for livestock, not dogs, but that it has worked for dogs for such a long time that Vets had no problem prescribing it.

As I live and breath, I actually had a fleeting thought and wondered a few days ago whether Ivermectin might be effective at treating Coronavirus.  I figured, “You’re not a medical doctor, never even bring this up because people will think you’ve fallen off your rocker.”

Then this.

An anti-parasitic drug available throughout the world has been found to kill COVID-19 in the lab within 48 hours.

A Monash University-led study has shown a single dose of the drug Ivermectin could stop the SARS-CoV-2 virus growing in cell culture.

“We found that even a single dose could essentially remove all viral RNA (effectively removed all genetic material of the virus) by 48 hours and that even at 24 hours there was a really significant reduction in it,” Monash Biomedicine Discovery Institute’s Dr Kylie Wagstaff said on Friday.

While it’s not known how Ivermectin works on the virus, the drug likely stops the virus dampening the host cells’ ability to clear it.

The next step is for scientists to determine the correct human dosage, to make sure the level used in vitro is safe for humans.

“In times when we’re having a global pandemic and there isn’t an approved treatment, if we had a compound that was already available around the world then that might help people sooner,” Dr Wagstaff said.

“Realistically it’s going to be a while before a vaccine is broadly available.”

Before Ivermectin can be used to combat coronavirus, funding is needed to get it to pre-clinical testing and clinical trials.

Ivermectin is an FDA-approved anti-parasitic drug also shown to be effective in vitro against viruses including HIV, dengue and influenza.

But if we’re waiting for FDA approval, we could be waiting for a very long time.  The bureaucrats get their say.


Comments

  1. On April 5, 2020 at 9:36 pm, Fred said:

    I’ve taken Ivermectin. Interesting that it (may) kills this virus. Not surprised if one single pill would do it either. I experienced Zero side effects, OBTW. Hmm? It kills everything. 30 days after completing the prescribed round make sure to repopulate your gut with (not vinegar based) fermented foods and a variety of quality live probiotics.

  2. On April 6, 2020 at 7:57 am, Drake said:

    Yes! I commented something along these lines last week. The CDC is worthless and the FDA is actively killing people at this point. I want to reach through my TV and punch any doctor repeating that only “anecdotal evidence” crap about cloriguine and other drugs.

    Since they weren’t doing drug trials in January and February, they should forfeit all ability to hold up anyone’s treatment to protect their bureaucratic turf.

  3. On April 6, 2020 at 10:41 am, Wes said:

    Stacking the recounting of this information with many others makes me ponder that, while the hemp industry seems to be growing or at least percolating along, do we have enough lamp posts?

    Bride of many decades benefitted from an “off-label” use of a cancer drug that shrinks cancer cells to oblivion and, in much smaller dosage, shrunk & closed off the little bleeders inside that were causing her hemoglobin loss due to a completely non-related illness. We were fortunate that it was covered because the Doc knew how to write “creatively” and worked because the Doc (American of Indian descent) viewed US bureaukrats as someone to be told to pound sand, he being the Doc, they not.

    I doubt the mainstream High Church of Medicine will ever display the collective middle-finger to the FDA.

  4. On April 6, 2020 at 12:19 pm, Fred said:

    @Wes, good points. I took Ivermectin “off label” as well, OBTW.

  5. On April 6, 2020 at 3:07 pm, Frank Clarke said:

    FDA delenda est.

  6. On April 7, 2020 at 8:38 am, Ned said:

    FDA joins the list of another bloated agency that exists “for your protection” just like the police do.

    I’d like to see an agency that doesn’t screw up everything it touches. I guess that’s a unicorn.

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