After President Trump declared that he uses hydroxychloroquine, the Food and Drug Administration (FDA) walked back its advice against the drug and seemingly all others as well. “The decision to take any drug,” the head of the agency said, is “between a patient and their doctor.”
The FDA has had two shining moments during the spread of the coronavirus. At neither time did the agency do something so much as it undid something.
The first moment was March 13, when the FDA dropped its onerous approval process for coronavirus test kits. It was still late to the game, but the move helped save face.
On Tuesday, there wasn’t much left to preserve after the FDA commissioner issued a statement essentially nullifying much of his own bureaucracy’s purpose for existing.
“The decision to take any drug is ultimately a decision between a patient and their doctor,” FDA commissioner Dr. Stephen Hahn said in an emailed statement to various news outlets, including the Hill and CNBC.
This came in response to President Trump’s remarks that same day that he had been taking hydroxychloroquine (HCQ) as a preventative measure against COVID-19 for “a couple weeks.”
“I think people should be allowed to,” Trump said.
The FDA would say that, technically, people are allowed to use HCQ. It’s just not government approved for anything other than malaria, lupus, and rheumatoid arthritis. And although doctors may, and do, prescribe it for “off-label” treatments, a prescription—a government-mandated document that controls public access—is still required.
What does it matter, beyond the legal consequences, whether a prescription is written for HCQ or not? In Trump’s case, the president merely requested HCQ from his doctor. It wasn’t even recommended to him. Suppose no prescription were required and HCQ were over the counter. Might Trump or anyone else consult their physician or a pharmacist anyway?
All the prescription law can do is potentially weaken the doctor-patient relationship.
As the late Dr. Thomas Szasz observed in his book Our Right to Drugs, a “colossal charade” between patients, doctors, insurance companies, and the government arises from this regulatory framework of prescription drug laws. He wrote:
The fact that our drug laws require people to secure a prescription for many of the drugs they want (but cannot get on the free market) fosters a mutually degrading dishonesty between physicians and patients.
The FDA’s latest statement that taking “any drug” is a decision between doctors and patients contrasts sharply with the one it made a little over three weeks prior regarding HCQ. On April 24, the agency cautioned against using HCQ “for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems.”
Although not a direct contradiction, the May 19 statement makes a substantial difference in the April 24 statement’s effect. That’s because it’s reasonable to expect that the FDA will typically enforce its opinions through a perceived threat of coercion.
As investigative reporter James Bovard wrote in this space last month, the FDA has a history of using intimidation tactics to secure compliance with unfinalized prohibitions, including against “off-label” drug treatments.
In 1991, then FDA commissioner Dr. David Kessler told the Drug Information Association that the FDA would use seizures, injunctions, and prosecutions to enforce its ban on drug companies sharing “off-label” use information with doctors. The ban was never formalized, but Kessler 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.”
Kessler would not be proud of the current FDA head, who concedes that “ultimately” doctors and patients have the decision-making power over drug use.
In 1992, Kessler said quite the opposite:
If members of our society were empowered to make their own decisions…then the whole rationale for the [FDA] would cease to exist.
At least Kessler was more consistent than Hahn is. There’s no sign that Hahn will follow through his words that doctors and patients may decide how “any drug” should or shouldn’t be taken.
That’s too bad, because when the doctor-patient relationship isn’t interrupted by bureaucratic third parties or red tape, it is the strongest bulwark against drug and prescription abuses.
What benefit is a layer of FDA regulations that simply restrict everyone’s freedom for the sake of those who will circumnavigate the rules, anyway? The principle is more commonly accepted in the gun control debate, but it is the same in the prescription drug control debate.
Trump got it right when he said people should be allowed to decide for themselves. His words clearly influenced the FDA’s messaging. We can allow ourselves a little hope, but realistically, substantial reform towards more freedom in medicine may have to wait until a worse crisis demands it.
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As an aside, the controversy over HCQ’s use – and apparent worldwide damnation of the drug (since President Trump suggested it) has raised a few eyebrows recently.
Consider these two recent examples:
The Indian government is courting controversy by continuing to give the antimalarial drug hydroxychloroquine to health care workers on the front lines of the fight against the coronavirus, despite safety concerns that have prompted the World Health Organisation to pause a large-scale trial of the drug.
Scientists at the Indian Council of Medical Research (ICMR), the body leading the coronavirus battle in India, say their studies have shown definitively that the drug – also known as HCQ – helps to prevent infections among health care workers exposed to Covid-19.
The ICMR has conducted three studies, involving control groups of between 330 and 1,300 people, in which frontline health care staff have taken the drug as a preventive measure.
And the Australian study that has been ‘touted’ around the world as “proving” HCQ is unsafe against COVID-19 is now being questioned openly…
Questions have been raised by Australian infectious disease researchers about a study published in the Lancet which prompted the World Health Organization to halt global trials of the drug hydroxychloroquine to treat Covid-19.
Specifically, the study, led by the Brigham and Women’s Hospital Center for Advanced Heart Disease in Boston, examined patients in hospitals around the world, including in Australia. It said researchers gained access to data from five hospitals recording 600 Australian Covid-19 patients and 73 Australian deaths as of 21 April.
But data from Johns Hopkins University shows only 67 deaths from Covid-19 had been recorded in Australia by 21 April. The number did not rise to 73 until 23 April. The data relied upon by researchers to draw their conclusions in the Lancet is not readily available in Australian clinical databases, leading many to ask where it came from.
“If they got this wrong, what else could be wrong?” Dr Allen Cheng, an epidemiologist and infectious disease doctor with Alfred Health in Melbourne, said. It was also a “red flag” to him that the paper listed only four authors.
The now questionable findings prompted researchers from around the world to reassess their own clinical trials of the drug for preventing and treating Covid-19. The World Health Organization halted all its trials involving hydroxychloroquine due to the concerns raised in the study about its efficacy and safety.
Bear in mind that – before Trump’s recommendation – it was once viewed as among the most promising medicines to treat the virus, and the Australian Department of Health had been stockpiling millions of doses of the drug in case clinical trials found it proved useful.
Last month Australia’s chief scientist, Dr Alan Finkel,urged the public to be cautious about findings and interpretations from studies in the race to find cures and treatments for Covid-19.
Serious concerns have being raised by bioethicists, clinicians and scientists that scientific rigour and peer review is falling by the wayside in the race to understand how the virus spreads and why it has such a devastating impact on some people.
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It is difficult to avoid the conclusion that HCQ/zinc is being sidelined in order to clear the way for a profitable vaccine and a vaccination mandate.