Trump storms into medical-ethics minefield by flogging drugs’ untested use

drugpromotrump-300x178President Trump has stormed past accepted professional practices and triggered alarms about ethical decision making by caregivers, as he persists in his noisy advocacy for treating seriously ill patients with Covid-19 infections with an unproven pair of prescription drugs.

Promoting this drug regimen — on social media and in White House news conferences — has pitted the onetime real estate developer and reality show host with an undergraduate economics degree squarely against Dr. Anthony Fauci, one of the nation’s foremost infectious disease experts at the National Institutes of Health.

They have squared off publicly, with the leader of the free world talking about how he “feels good” about giving patients two, long-used antimalarial drugs — chloroquine and hydroxychloroquine (aka plaquenil) — while Fauci has insisted such prescribing has no basis now, and, at best, should be subjected to rigorous clinical trial to determine their effectiveness.

This is no simple, easy disagreement, especially as the planet grapples with a coronavirus pandemic. It underscores how fast evidence-light arguments can persuade partisans of public health policy to adopt approaches that can unnerve highly trained experts.

Doctors and medical researchers, unlike lay people, know that there can be serious consequences for spit-balling and hip-shooting with the treatment of gravely ill patients. They do not want to be accused of shady experimentation, nor do they want to foster or dash the hopes of the sick and their loved ones. They know they can be held legally responsible, as well as putting their precious and hard-won reputations at risk with untested treatments. Indeed, a major challenge of doctors experimenting with drugs or treatments involves their protecting patients’ fundamental right to informed consent. This means they are told clearly and fully all the important facts they need to make an intelligent decision about what treatments to have, where to get them, and from whom.

Michael Lockshin, a doctor at the Hospital for Special Surgery in Manhattan, told the New York Times that medical experts are angry at the president’s slap-dash pushing for antimalarial drug use to treat Covid-19 patients: “Rheumatologists are furious about the hype going on over this drug [chloroquine, prescribed to treat lupus and arthritis]. There is a run on it and we’re getting calls every few minutes, literally, from patients who are trying to stay on the drug and finding it in short supply.”

Trump has argued that chloroquine or its analog hydroxychloroquine might be paired with azithromycin, a common anti-bacterial agent, to battle the coronavirus. Both already have been approved and are widely used, but not in coronavirus treatment. The president suggests this is a minor off-label application. Chinese researchers, who have not yet published formal results of their tests of this combo, reportedly have spoken to Western doctors about the pairing in their care of coronavirus patients. The theory gained traction in the Silicon Valley. French researchers have published a small and limited paper on the drugs’ use.

That French research, however, has gotten marched across social media, too often by non-experts who proclaim it shows without question why the drugs should be used.

Here are some of the caveats that make medical specialists queasy. The French test involved not more than a dozen patients and a similar number of control subjects. The drug combination appeared to reduce by a few days the severity of the infection, but the study did not determine that the medications were the sole reason the small number of patients recovered. Further, even among this slice of seriously ill individuals, the researchers recorded one death they could not explain. That is not a good thing in so small a test group.

That still has not deterred enthusiasts, including a group of researchers who put out maps showing where malaria is a prevalent illness and where, at least for now, Covid-19 has not spread or done so slowly. These researchers have asked if this is a sign that wide use of antimalarial drugs in these nations — most in Africa and South Asia — may have coronavirus resistance.

There’s a problem with this theory from the outset, however: The map simply may be showing that the virus has not spread into the developing world, or that the many impoverished nations have not tested for it and detected it — yet. Further, while it may be true that quinine-related medications are cheap and often recommended for poor people sick with malaria in the developing, studies also show that their actual uptake may be far less than believed. That’s because the drugs have powerful side-effects and poor people may accept an initial dose but then fail to follow-through with full treatment regimens.

Doctors and presidential critics have hastened to point out that the antimalarials can cause liver and heart damage and blindness. They can make patients taking them foggy minded, nauseous, and give them the runs.

That has not stopped advocates from promoting the meds online, including with boasts that individuals have stockpiled supplies and started taking the drugs, in preventive fashion and without a doctor’s advice.

Question this conduct and the responses can be furious, as a West Coast colleague has discovered in exchanges on social media. The rebuttals (by individuals who shall be unnamed and not shamed) can dive fast into conspiracy theories, including one that accuses the federal Centers for Disease Control and Prevention of secreting from the public information about this coronavirus care. That claim is based on the agency’s routine publication, without fanfare, of a scientific paper showing that quinine-related drugs in petri dish experiments showed effectiveness in killing coronaviruses in primate cells.

The claims about this paper fall apart fast, because, to start, it is publicly accessible, with ease. Further, the paper’s findings, part of the extensive research that CDC experts conduct as part of their taxpayer supported work, are limited and unsurprising — drain cleaner or ordinary soap would kill viruses if poured on cells in test tubes and with the parasitic particles attacking them.

More seriously, the tussle over Covid-19 care also may be seen as part of the larger, longer-running battle over a health care controversy dubbed “the right to try.” Trump signed a bill backed by Libertarians and Republicans that proponents asserted would advance terminally ill patients’ chances of accessing and getting doctors to give them experimental treatments. At its core this bill and its point of view may have been summarized by Trump as he talked in one news conference about the untested antimalarial regimen: “What do we have to lose? Why not?” he asked, trailing off into saying, “We have lots and lots of very sick people.”

Doctors and medical ethicists have pointed out the “right to try” bill was unnecessary because specialists already work with the federal Food and Drug Administration for exemptions to allow promising but unapproved medications to be prescribed to patients with dire illness. Further, they have said that “right to try” approaches raise false hopes, may lead to unacceptable experimentation on desperate patients, and it can create inequitable care. Experimental therapies can come with extraordinary price tags, meaning only wealthier or well-connected patients might access them. Continuing costly treatments in futile cases also can be painful, invasive, wasteful, and cruel, doctors say.

In my practice, I see not only the harms that patients suffer while seeking medical services, but also their struggles to access and afford safe, effective, and excellent medical care. This has become an ordeal due to the skyrocketing cost, uncertainty, and complexity of medical treatments and prescription medications, too many of which turn out to be dangerous drugs.

Although the president has insisted, for almost four years now, that he and his administration would help patients by cutting the cost of prescription drugs and medical services, this has not occurred. Costs have kept spiking, especially as Trump and the GOP have slashed at the Affordable Care Act, Medicaid, Medicare, and other programs that seek to assist Americans with their health care. The administration also has pushed the federal Food and Drug Administration to hurry up what has been rigorous testing of prospective prescription medications, so potentially beneficial — and yes, harmful, too — meds can get to consumer markets. The FDA’s expedited approvals have concerned patient safety advocates, who warn the agency isn’t doing enough to safeguard the public.

The antimalarial drugs will undergo careful tests to determine their usefulness against Covid-19. Until then, it is sad that Trump has put the public in the position in already tough times of choosing his credibility on an issue of medical care versus respected practitioners like Fauci. The answer should be clear, though partisanship, sadly, may cloud some minds.

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