The food and drug bureaucracy, like every bureaucracy, is far from a gold standard operation.
Institutional trust is at an all-time low, but that doesn’t seem to include the FDA, if headlines are to be believed. After a summer of free donuts, the agency’s approval of the Covid-19 vaccine was supposed to be the gold star to make any remaining hesitants into true believers.
Having just approved the Pfizer vaccine at the end of August, and a Pfizer-only booster shot less than a month later, the FDA is staying under the public eye as a new experimental drug from Merck, and the same vaccines being dosed for 5 to 11 year olds, await the agency’s approval. Following the Red Sea parting that has been the latest vaccine mandates, the public’s willingness to swallow this new pill may be a good indicator of whether the agency has remained unstained by the general muck. Either way, it is worth considering whether the FDA’s behavior actually merits such trust, whatever the public opinion in your chosen echo chamber. After all, its approval is the golden ticket that allows doctors to prescribe a new drug, thus enabling the steady stream of cash from insurance companies to pharmaceuticals, and enabling you to feel the physical realities of that drug, for better or worse.
What does it mean for a drug to be safe? The FDA does not claim its approval of a given drug guarantees safety, nor could it. To conservatives who reject a philosophy of total risk aversion, this should not be troubling; the warning against safetyism cuts both ways, after all, meaning if we’re in favor of personal responsibility rather than government overreach in controlling the effects of certain viruses, we’re also for personal responsibility in accepting the potential risks of a drug when we take it. While the purpose of the FDA is to prevent some truly horrendous concoctions from reaching public use, we also are responsible to choose wisely—which, as an aside, assumes we have a choice.
But personal responsibility works in tandem with public trust, which must be earned. What we can and should expect of the FDA is basic competency, honesty, as well as independence from special interests, to merit this trust. As it turns out, the nature of the process by which the agency determines a drug is safe for prescription, and the nature and number of their past failures, suggests theirs is not a stamp worth its standard in health and safety, much less science.
FDA approval, that thin line that stands between you and whatever a lab has lately produced, can be determined by as few as one successful study. This evidence can be, and often is, provided to the agency by the company that makes the medical product, meaning that a drug manufacturer that wishes to have its product approved performs its own clinical trials. The FDA then examines the trial before deciding whether the benefits of the drug outweigh the risks to those who would take it. What that actually means is whether it’s better than nothing, and only in the short term. As of 2014, 37 percent of approved drugs were only backed by a single study and 68 percent compared new drugs only to placebos, rather than to previously existing drugs. (A 2013 study in the Journal of Law, Medicine and Ethics (JLME) showed about 90 percent of all new drugs approved by the FDA since the 1980s are little or no more effective for patients than previously existing drugs.)
The name Eli Lilly Pharmaceuticals probably wasn’t familiar to you until recently. The pharmaceutical company provided monoclonal antibody treatments for Covid earlier this year, before the U.S. government paused distribution in March. The government just purchased another round of Lilly’s antibody treatments in September. In the late 1980s, Lilly conducted a series of 20 studies in order to prove the effectiveness of their antidepressant drug, Prozac. Only three studies were ever submitted to the FDA for approval; the other 17 failed. Dr. Alexander Bingham, clinical psychologist and professor of Psychological Research at John F. Kennedy University, once described this approval process to Drugwatch: “By its own report, the FDA challenged the validity of all three studies, citing both procedural and statistic errors, and denied Lilly approval for Prozac twice,” Bingham said. Yet, after Lilly submitted its third data set, the FDA approved the drug. According to Bingham, there were no new trials between the failed attempts and the successful one, “only statistical manipulation and repackaging of existing data to create more favorable results.”
Follow the money. As the JLME paper points out, part of this racket was started in 1992 when user fees were authorized, after AIDS activists protested the agency’s slow review process in the 1980s. The Prescription Drug User Fee Act allowed drugmakers to pay the FDA to hire more reviewers. As NPR reported in 2020, “the FDA collected $29 million in fees in 1993, the year after Congress passed the Prescription Drug User Fee Act for the first time. The fees rose to $908 million in 2018. That year, industry fees amounted to about 80% of the money spent on FDA employee salaries for drug reviews.”
The introduction of user fees flipped the agency’s priorities entirely. Pharmaceutical companies became the client, rather than the U.S. taxpayer and potential patient. Infected with the industry’s demand for speedy authorization, and pharmaceutical dollars, the FDA’s average review time has shortened significantly in recent years, down to 10.1 months in 2018, compared with 2.8 years between 1986 and 1992. Meanwhile, former FDA commissioners become Pfizer board members after they retire from the agency with no one batting an eye. The military industrial complex is getting a run for its dark money from the other MIC on the block—the medical industrial complex.
This rapid approval has come at the cost of serious health considerations, and, in some cases, several lives.
One 2016 study, in the International Journal of Health Services, found that for every 100 new FDA approved drugs, 27 were withdrawn for serious safety reasons in the first 16 years after a drug’s approval.
The study authors wrote:
FDA approves new drugs significantly faster than the regulatory bodies of Europe, Canada, and Japan. Unlike the United States, most European Union countries require that new drugs undergo a secondary review process comparing their efficacy to the existing standard of care before health insurance plans will pay for them. Furthermore, the European Union, Canada, and Japan prohibit direct-to-consumer advertising, which is known to increase prescribing of the advertised drug.
Which means that instead of further clinicals, the general population plays the role of that secondary trial. Serious problems with drugs are not discovered until five or so years after they are approved, often after the drug has been prescribed to thousands of patients. And again, nearly one third of all FDA approved drugs were involved in some kind of safety event after they hit the market. Prescriptions for such drugs have passed 100 million since the agency’s conception.
Among the most famous FDA drug recalls is Chantix, a Pfizer anti-smoking drug which was later discovered to contain high levels of cancer-causing nitrosamines. Another recall, Accutane, was a strong anti-acne drug often prescribed to young women with a side of birth control to control the drug’s side effects, which included cycle irregularities. Accutane was on the market for 27 years before it was recalled for increasing the risk of birth defects, miscarriages, and premature births when used by pregnant women, among other side effects, including increased suicidal tendencies. One listing of FDA recalls reports: “Over 7,000 lawsuits were filed against the manufacturer [of Accutane] over the side effects including a $10.5 million verdict and two $9 million verdicts.”
Another Pfizer drug, Rezulin, an anti-diabetic and anti-inflammatory medication, was recalled after at least 90 patients experienced liver failures and at least 63 died.
It’s by this standard that the Covid-19 vaccine has been made mandatory for every single active duty member of the military, every government contractor, and soon, every employee of a business above a certain threshold. By this standard, state travel has been restricted, as Americans can no longer visit every state in the union without showing proof that they’ve gotten the newest drug. And it is this agency’s analysis of your risk versus the pharmaceutical’s benefit that is on its way to preventing you from entering businesses freely.
In the words of Shakespeare’s greatest and worst hero, “In the fatness of these pursy times / Virtue itself of vice must pardon beg.”