Who Regulates the Regulators?

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Commentary

I’ve written here before about our attitude of “safe until proven otherwise” and how, under the guise of allowing innovation, it also produces a huge burden of avoidable harms.

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.

“The small benefits do not outweigh serious safety concerns,” researcher Nina Zeldes told the FDA’s advisory committee, according to the British Medical Journal. “Like other antipsychotics, this is a drug that can kill patients without providing a meaningful benefit.”

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?

The FDA has so far resisted the opportunity to make any public comments on the licensing process for the drug.

A sign for the Food and Drug Administration outside of its headquarters in White Oak, Md., on July 20, 2020. Sarah Silbiger/Getty Images

Critics of the FDA, including professor Lon Schneider at the University of Southern California, believe that the FDA now has a “lower standard of approval” today than it did 20 years ago. This is substantiated in two recent studies. Since the passage of the 21st Century Cures Act in 2016, which was intended to accelerate the approval of medicines that would otherwise take many years to be approved, a greater proportion of drugs have been approved based on just a single study. Out of 37 drugs approved by the FDA in 2022, 24, or 65 percent, were approved with just a single study, compared with just four out of 20, or 20 percent, in 2016, before the Cures Act was passed.

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.

One obvious reason drug companies and the FDA might resist transparency is the massive influence of money over the approval process. Robert Whitaker, writing in the British Medical Journal, notes that, in the case of brexpiprazole, the FDA was lobbied by a number of patient advocacy groups, including the Alliance for Aging Research and Leaders Engage on Alzheimer’s Research, the former of which is funded by Otsuka, one of the two manufacturers of the drug. Otsuka and Lundbeck have forecast additional annual sales of $1 billion in the United States from brexpiprazole, which costs $1,400 for a monthly dose.

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.

Molnupiravir, an experimental COVID-19 treatment pill, in a handout photo released by Merck & Co. Inc. on May 17, 2021. Merck & Co. Inc./Handout via Reuters

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.”

Inducing mutations in a virus at any time, least of all in the middle of a global pandemic, might sound like a bad idea even to a layman. Experts, including a member of President Joe Biden’s Health Equity Task Force, agreed and warned of the danger that the drug could cause newly mutated versions of the disease to escape users’ bodies and infect others, driving the creation of potentially harmful new variants that could worsen the pandemic. These concerns were reportedly blithely dismissed by Merck representatives as a “hypothetical concern” during the drug’s development and during the FDA approval process, but in January of this year, a study showed that mutations characteristic of the drug were visible in a number of new variants that were discovered after its introduction. Other studies have shown that the drug could “supercharge” the virus in the bodies of immunocompromised patients, again with the potential to create new variants, and, just as damningly, that the drug had no effect in reducing COVID-19 hospitalizations or deaths in high-risk vaccinated patients.

Again, we might ask, why on earth did this drug ever receive approval? In this case, we also have to factor in the involvement of the U.S. government itself, which heavily subsidized the development of the drug and signed a $1.2 billion contract with Merck for nearly 2 million doses months before the clinical trials had even finished. It’s hard to resist the conclusion that the drug’s approval for use was a foregone conclusion, whatever the trials said. The U.S. government wanted a new drug to treat COVID-19, and that’s what it got. Merck got a lot of money. The company would supply a total of 3 million doses of its drug to the U.S. government by February 2022, at a cost of $712 per patient, an estimated 4,000 percent markup on the actual cost of producing the drug. Global sales of the drug reached $5.7 billion by the end of that year.

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.

Democratic Presidential candidate Robert F. Kennedy Jr. speaks at the Iowa State Fair in Des Moines on Aug. 12, 2023. Madalina Vasiliu/The Epoch Times

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.”

Views expressed in this article are opinions of the author and do not necessarily reflect the views of The Epoch Times.