Once upon a maybe less-enlightened time, in the 1920s and 1930s, men flocked to goats — specifically, their gonads, famed for spurring virility. The purveyor, a Kansan, Dr. John Kimball, graduate of the Eclectic Medical University, sewed the golden nut under the skin of the scrotum. Soon he advertised this cure throughout the United States, via radio stations which he owned. (When he lost his Kansas station’s license, he bought a station in Mexico, to broadcast over the border. Other stations were doing the same — a precursor to the web’s limitless reach). The market was vast, with no governmental nannies to shriek “no, you can’t,” either to him, or to his customers. He almost became governor of Kansas. But elixirs fade. In that laissez faire time, so did the popularity of goat testicles. The American Medical Association rose up to protest (as it protested other competing treatments, including homeopathy). A 1939 libel case ended the boondoggle. (Watch the 2016 documentary, “Nuts,” by Penny Lane).
Today we have the government-as-watchdog; and for this, all of us, even those who would shrink Uncle Sam to a micro-presence, should cheer. Today’s treatments are not so preposterous as goat testicles; the professionals standing behind them are not graduates of Eclectic Medical. Many treatments sound plausible. And the demand is ever strong, fueled by patients desperate for relief and investors desperate for profit.
Uncle Sam (along with another conservative bogey, the World Health Organization) stands as a safeguard. Consider the COVID cures,: ivermectin (intended to kill parasites in horses), hydroxychloroquine (can cause liver inflammation), cocaine (touted in viral tweets), drinking bleach, saltwater mouth-rinses (the virus lives in the respiratory tract, not the mouth). Recently Uncle Sam, via the FDA, declared that it would limit access to two treatments, made by Eli Lilly and Col, and Regeneraon Pharmaceuticals, because those treatments, though effective against the Delta variant of COVID, were unlikely to work against the Omicron variant. Let those treatments rest in peace.
Some politicians, though, won’t let them rest in peace. Plugging into a populist anger against “the experts,” conservatives have seized “laissez faire” as a strategy. After the FDA blocked use of of the two treatments for Omicron, Florida’s Gov. Ron DeSantis objected. Flouting the FDA’s stance on hydroxychloroquine. Republican legislators in 11 states have introduced bills to prohibit medical boards from sanctioning physicians who prescribe it. In Tennessee and North Dakota, the bills passed.
The government tries to ground its recommendations in as much evidence as it can muster.
Sometimes those clinical trials take years, while investors, as well as patients, wait. And the grapevine, fueled by those investors and patients, can be strong enough to overrule “the evidence.” Consider the bipartisan 1st Century Cures Act that lowers the “evidentiary standards” for a government green light. More than a thousand lobbyists spoke in favor. Former President Trump vowed to open the floodgates to scores of drugs, blocked by the FDA. The Trump-era candidate to head the FDA, an investor, opined “Let people start using (the drugs) at their own risk.”
The FDA even oversees drugs’ advertising. All those gloriously happy media testimonials to the wonders of any drug carry a disclaimer about the gruesome possible side effects, from mild to lethal. This year the FDA rebuked Eli Lilly for its overly rosy predictions in Instagram ads that Trulicity, a Type 2 diabetes drug, would lower A!C in all patients.
Admittedly, the trials do not always show a clear crystal ball as to efficacy or cost-effectiveness. Aduhelm, the breakthrough Alzheimer’s treatment spurred excitement among the millions of Americans who live with the disease, who live with somebody who has the disease, or who fear the disease in their future. Aduhelm might slow Alzheimer’s. No other treatment had looked so promising. But the scientific community was not unanimous. And Medicare estimated the cost, initially pegged at $56,000 per patient annually, would come to $29 billion; in 2019 Medicare spent $37 billion on all drugs.
In the end, the Centers for Medicare and Medicaid Service was cautious, as were the Blue Cross/Blue Shield Plans, Kaiser Permanente, and the Department of Veterans Affairs. The FDA approved the drug for clinical trials, at a cost of $28,000 annually per patient. Canada has not yet approved Aduhelm, nor has the United Kingdom. Perhaps not surprisingly, the Wall Street Journal (Jan. 23) editorial, with its eye on investors, argued that the FDA represented “The Alzheimer’s Death Panel.”
For politicians, dependent on campaign contributions from hedge funds and their ilk, the laissez-faire rhetoric wins votes. And many internet-touted treatments, while not meeting the standards of clinical trials, do no harm. The treatments may have a placebo effect. But without Uncle Sam saying “Wait. No. Only in specific instances”, some patients will not end up with treatments that might work. We need this government-watchdog.
Joan Retsinas is a sociologist who writes about health care in Providence, R.I. Email retsinas@verizon.net.
From The Progressive Populist, March 1, 2022
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