First, Do No Harm

59 years ago a wonder drug swept Europe and the UK promising a restful sleep to anxious expectant mothers. 

FTA-By 1960, Thalidomide was marketed in 46 countries, with sales nearly matching those of aspirin.

Around this time, Australian obstetrician Dr. William McBride discovered that the drug also alleviated morning sickness. He started recommending this off-label use of the drug to his pregnant patients, setting a worldwide trend. Prescribing drugs for off-label purposes, or purposes other than those for which the drug was approved, is still a common practice in many countries today, including the U.S. In many cases, these off-label prescriptions are very effective, such as prescribing depression medication to treat chronic pain.

However, this practice can also lead to a more prevalent occurrence of unanticipated, and often serious, adverse drug reactions. In 1961, McBride began to associate this so-called harmless compound with severe birth defects in the babies he delivered. The drug interfered with the babies’ normal development, causing many of them to be born with phocomelia, resulting in shortened, absent, or flipper-like limbs. A German newspaper soon reported 161 babies were adversely affected by Thalidomide, leading the makers of the drug—who had ignored reports of the birth defects associated with the it—to finally stop distribution within Germany. Other countries followed suit and, by March of 1962, the drug was banned in most countries where it was previously sold.”

While the FDA at the time declined to approve the drug Thalidomide state-side, it came very close, and was hardly the bastion of objective science. This close call led to an overhaul that tightened restrictions surrounding the surveillance and approval process for drugs sold in the US.

Over the past 20 years those processes have been slowly undermined and increasingly the FDA authorizes thread-bare clinical studies conducted by pharma with obvious conflicts of interest. Drugs rubber stamped by the FDA one day are pulled from the market the next. Late night TV is full of law firm ads asking if the audience has been harmed by a growing list of drugs that were once touted as “safe and effective”.

Libertarians call for the abolition of the Food and Drug Administration, not to eliminate food and safety processes already in place nationwide and directly managed by food processors and reputable drug companies, but to end the false sense of security the agency provides Americans, corrupt revolving door of agency staff into captured industries and the consistent failure it presents to the market.

We demand an open market that allows multiple competing voluntary private inspectors, much like Consumer Reports and other watchdog groups, who alert the public to dangers long before the FDA or its corrupt bureaucracy. 

Allowing any government or corporation to have a monopoly on the definition of human health is dangerous and unwise.

We are living through a moment in history that may change the American experience forever, and the FDA has been at the heart of each misstep and tragedy, without correction, without accountability and without direction.



An addendum on abolishing the FDA

This agency is directly responsible for the disastrous handling of Covid response, allowing home testing early in 2020 when it could have made all the difference, then pulling authorization and demanding all testing go through the CDC and HHS. With a testing bottle neck at the federal level state health departments were unable to ramp up testing to assure panicked state Governors that a health crisis in March 2020 was non-existent in most states. While New York, New Jersey and to a much lesser extent Washington State saw alarming numbers of positive tests and a handful of over run hospitals, Ohio in particular saw hospitals statewide at 96% empty and massively under used, waiting for a surge that never came.
The absurd delay in testing led to an over reliance on long discredited apocalyptic projections that led governors to over-react with lock downs and restrictions through the summer, forcing hospitals to stay empty much longer than was obviously needed. This has led to an increased fragility in our health care networks, as doctors and nurses were let go and hospitals closed.
Bizarre contradictory advice has been issued from the FDA ,and its sibling agency the CDC, over the course of the year, ranging from scientifically dubious “social distancing”, flip-flopping mask guidance, excessive quarantine and avoiding the much needed discussion on informed consent.

No government or corporation should have this much influence over public health. We demand good outcomes, not just good intentions. 




Michael Sweeney, At-Large member, FCLP