“Doctors couldn’t help. They turned to a shadow system of DIY medical tests,” reports the Washington Post. These tests correctly revealed problems ranging from stomach ailments to cancer — saving lives — but the FDA views consumers’ access to these tests as “loophole” that needs closing:
Angelika Sharma was desperate. An array of basic first foods — from bananas to sweet potatoes — caused her 6-month-old Annika to vomit uncontrollably, so many times in one night that she landed in the hospital for dehydration.
Half a dozen pediatric specialists largely dismissed her daughter’s ailments, Sharma said, forcing her to leave her job as a hospitality executive, because “you can’t just have any babysitter looking after a child” with such serious reactions to food.
After a year and a half, an answer came finally in the form of a Facebook ad for Tiny Health, a Silicon Valley start-up that could test her baby’s gut microbiome. Using a bead of stool swabbed from a diaper, the company diagnosed the problem: Annika’s gut was overcrowded with P. vulgatus, a common bacteria. A company nutritionist recommended a probiotic, sauerkraut and exposure to animal microbes through daily visits to the petting zoo.
Within months, Annika’s food reactions were normal. More tests showed a gut transformed…..
A public eager for answers is swarming this parallel medical ecosystem. The home diagnostics market generates $5 billion annually and is expected to nearly double by 2032, according to the market research firm Precedence Research.
Venture capitalists and entrepreneurs told The Washington Post that they envision a world where frequent at-home testing is a routine part of life, enabling everyone to become “the CEO of their own health,” said Luca Springer, who co-founded a Silicon Valley start-up that aims to make cancer testing as simple as a home-pregnancy test.
Patients in remission from cancer, for example, could use urine strips to check if the disease has returned, he said, confirming the results with their doctor. He noted that at one time home pregnancy tests were considered scandalous and that most cancers are still detected way too late.
But the boom angers some doctors….
These doctors have an anti-competitive motive for opposing home medical tests, which reduce the need to visit the doctor’s office, resulting in less income for doctors. These home medical
tests often fall into a regulatory gap. While the U.S. Food and Drug Administration generally reviews all but the lowest-risk medical tests, it doesn’t supervise “wellness” tests marketed directly to consumers. Other start-ups avoid stringent FDA review by having physicians oversee some part of the testing process — creating what experts call a two-track system of standards….
Some professional [medical] societies have cautioned against taking certain home tests….
They offer options to those feeling let down by conventional doctors. Sharma credits Tiny Health’s gut-biome test, which was developed by a Mayo Clinic microbiologist but not approved by the FDA, with providing “a mind-blowing tool you can’t get from the traditional medical establishment.”
The FDA is starting to pay attention: Regulators finalized a contentious rule in April to begin holding lab-made tests to the same standards as conventional ones, phasing out a historically hands-off position in response to the ballooning industry….
Still, businesses are charging ahead. Y Combinator, the prominent start-up incubator, funded Springer’s Cleancard last year. Function Health, a start-up founded by a Cleveland Clinic doctor in 2022, sells a $499 out-of-pocket membership offering more than 100 different lab-drawn tests, including for heart health, immunity and toxins. CVS and Walgreens enlisted San Francisco start-up ixlayer in 2022 to offer home tests for sexually-transmitted diseases, kidney function, diabetes and cardiovascular disease. Testing giant LabCorp recently launched a line of basic home-test kits called LabCorp OnDemand….
A new FDA rule will phase in a process that would require certain lab-developed tests to undergo a rigorous review before hitting the market, meet manufacturing standards and report bad patient outcomes. Opponents say the rule would stifle innovation, and Everlywell has argued it could significantly limit access to critical tests to people in medically underserved areas…
Requiring FDA approval for these useful home medical tests will prevent them from being sold for years or decades. The FDA didn’t approve a home test for HIV until 24 years after it first received an application. According to an FDA advisory committee, the test “holds the potential to prevent the transmission of more than 4,000 new HIV infections in its first year of use alone.” That means thousands of people likely got infected with AIDS as a result of the delay in approving it. As Roger Parloff of Fortune noted, the FDA’s delay in approving the home HIV test is a “scandal.” It likely caused the deaths of thousands of people, given the mortality rate from AIDS. It may also have caused billions of dollars in additional costs for taxpayers, given that AIDS is a costly and debilitating disease to treat, resulting in treatment costs of perhaps $600,000 per AIDS sufferer.
The FDA is a huge impediment to accessing life-saving medical devices and drugs. FDA employees commonly take years to approve life-saving drugs. That results in the deaths of hundreds of thousands of people who could have been saved by earlier approval of those drugs. For example, at least a hundred thousand people died waiting for the FDA to approve beta blockers. One of the FDA officials involved in delaying their approval was John Nestor. Nestor was notorious for following rules in ways designed to frustrate and inconvenience other people. As the Journal of American Physicians and Surgeons notes:
Nestor had the unique habit of getting into the leftmost lane [on the highway] with his cruise control set at 55 mph, the posted speed limit. He would drive at this speed regardless of what came up behind him. Cars would zoom up close to his rear bumper; drivers would flash their lights and blast their horns,some swerving around him on the right while giving him the finger—none of this fazed Nestor in the least. As he explained it, 55 mph was the law, and he had a right to drive in whichever lane he chose: “Why should I inconvenience myself for someone who wants to speed?”
Nestor followed this rigid mindset in his work at the FDA. He was very good at using agency red tape, and minor risks or side effects of drugs, as an excuse to avoid approving life-saving drugs.
