Instead of adopting a conservative approach to new products, whether they be chemicals such as PFAS (per- and polyfluoroalkyl substances) or foodstuffs such as GMO corn, taking time to find out whether they have unexpected side effects in the long term, we press ahead as if a few short-term studies and the reassurances of industry and manufacturers were all the protection we needed.
This attitude is more or less baked into our system, and most of all, it benefits corporations, who produce these new products and then insinuate them into as many places as possible, generating enormous profits.
Of course, it’s not corporations but ordinary people who are left to deal with the dreadful effects of new products that turn out to be harmful—obesity and diabetes, auto-immune disorders and cancers, and reproductive issues, including birth defects and infertility.
These harms beget further harms, and further profits for corporations, because more new products are created to treat them. All drugs have side effects, and some are particularly unpleasant. Just recently, for example, it was revealed that anti-obesity “wonder drug” semaglutide—aka Wegovy/Ozempic—increases the user’s risk of inhaling the contents of their own stomach during surgery and of serious bowel obstructions. In both cases, the consequences could be lethal.
Now, it seems, regulators have gone one step further. Not content with “safe until proven otherwise,” the Food and Drug Administration (FDA) appears to have decided that “ineffective, probably harmful—but what are you going to do about it?” should be its new attitude, at least if what we can gather about the licensing process for new drug brexpiprazole (brand named Rexulti) is any indication. Despite that the drug was found to provide no clinically meaningful benefit in trials and to increase the risk of death significantly, the FDA has fast-tracked the drug’s approval. It’s now the first licensed antipsychotic drug for treating anxiety in dementia sufferers.
In three pre-approved trials, the death rate for users of the drug was four times higher than that for the placebo. In terms of efficacy, the drug brought only a 5.3-point improvement on a 174-point scale. Seventeen points is the minimum improvement deemed to be clinically important.
If you’re wondering why this drug has been licensed, you’re not alone.
Not only did the FDA have access to the seemingly unequivocal data from the clinical trials, but also it had to listen to opponents of licensing brexpiprazole during the approval process.
Earlier trials of antipsychotics for Alzheimer’s patients yielded exactly the same results as brexpiprazole, the only difference being that none of those drugs were licensed for use. So why was brexpiprazole?
With those trials that do take place, there’s a distinct lack of transparency. A significant proportion of trials aren’t disclosed before approval on the website ClinicalTrials.gov, which was established to ensure the public could follow the process of drug licensing better. Instead, in a majority of cases, clinical trials used to support a drug’s approval by the FDA can’t be scrutinized by outsiders until after the FDA has ruled. The general public has no idea of how many trials took place for a particular drug or why certain trials and not others were chosen in support of its approval.
In recent months, the lobbying tactics of semaglutide manufacturer Novo Nordisk have received significant coverage, including its lavish courting of academics, doctors, obesity charities, and education providers, but the truth is that, although Novo may be pursuing such tactics in an unusually aggressive manner, they’re standard practice when it comes to medicine.
If the drug approval process in the United States has now reached such an absurd state that a drug that’s known to have basically no discernible benefits can be licensed as “effective for use,” that doesn’t exhaust the potential for mayhem that the system allows. Far from it.
Just look at what happened during the pandemic. Of course, I could talk about the vaccines, but here’s an example you may not be familiar with. Molnupiravir was granted an emergency-use authorization in late 2021 as a therapeutic treatment for COVID-19. The drug, developed by corporate giant Merck, induces mutations in the virus’s genome, with the aim of causing benign changes that make the disease less harmful. The theory is that the drug will cause the virus to “mutate itself to death.”
It’s hardly news that where there are profits to be made, there’s potential corruption to be found. Nor is it news that medicine is prey to this tendency as much as any other field, perhaps even more. But we shouldn’t let these apparent truisms blind us to the possibility of a better system.
The candidacy of Robert F. Kennedy Jr. for president has made health, and the iniquities of Big Pharma, a political issue in a way that’s unprecedented in U.S. history. Although his promise of a reckoning with the vaccine manufacturers continues to attract the most attention, Mr. Kennedy has also promised a total overhaul of the way clinical research is performed and new medicines are licensed. This is to be welcomed, as I hope the information I’ve laid out above makes clear.
Mr. Kennedy’s entry into the presidential race has had a salutary effect, clearly influencing Donald Trump’s announcement of a presidential commission into chronic disease that would try to get to the bottom of why Americans are now so sick and only getting sicker. Mr. Trump sounded particularly Kennedy-esque in his declaration that more ad hoc treatments aren’t the answer and that Big Pharma is much too cozy with regulators.
The FDA is clearly part of the problem, but the causes of the United States’ unprecedented ill health run much deeper than poor regulation. The philosopher Ivan Illich used the term “iatrogenesis,” meaning “medically caused harm,” to refer to the way that modern reliance on medicine has stripped us of the ability to manage our health and our lives in ways that go beyond narrow technical interventions such as taking pills or injections or having surgery. Most chronic disease results, at base, from a mismatch between our ancient lifestyles and the way we live today, but medicine offers us no real tools to address this.
Fixing that mismatch would be a tall order indeed, and require a fundamental reordering of our society. In the meantime, the very least we can do is rally to hold medicine to its founding principle, laid down by the great Hippocrates more than 2,000 years ago: “First, do no harm.”
