The FDA is broken. It's controversial approval of an ineffective new Alzheimer's drug proves the agency puts profit over public health.
Skye Gould/Insider
- The agency's approval of a new Alzheimer's drug rightly caused an uproar.
- But the problems extend far beyond the drug, and far beyond the FDA: Drug science has been corrupted by the pharmaceutical industry.
- We must get money out of science to have safe and effective drugs.
- P.E. Moskowitz is an author and runs Mental Hellth, a newsletter about capitalism and psychology.
- This is an opinion article. The thoughts expressed are those of the author.
- See more stories on Insider's business page.
Earlier this month, three scientists on an independent panel at the Food and Drug Administration (FDA) resigned after the agency green-lit a drug that the scientists had recommended against approving. The drug, aducanumab, brand name Aduhelm, is designed to help Alzheimer's patients, but there's little evidence that it actually works, and monthly infusions of it cost $56,000 a year.
"This might be the worst approval decision that the FDA has made," Aaron Kesselheim, one of the resigned panelists, told The New York Times.
No one on the 11-member panel agreed with drug maker Biogen's claim that the drug could help with cognitive decline in early Alzheimer's patients, but the FDA approved the drug anyway. It will now be shipped to over 900 clinics, according to the New York Times, and within a few weeks, will be used on patients, prompting government watchdog group Public Citizen to issue a rare call that top FDA officials resign.
"The primary beneficiaries of the agency's action are Biogen and its shareholders, who undoubtedly are ecstatic about their soon-to-be-reaped windfall profits from sales of the company's exorbitantly priced but ineffective drug," Michael Carome, the director of the Public Citizen's health research group wrote in a scathing 8-page letter to the FDA.
One of the biggest problems with the drug is its cost: If just one in six Alzheimer's patients receive the drug, it could cost the US Medicare program $56 billion, more than the entire 2019 budget of the agency. About 5.6 million Americans had Alzheimer's in 2020, but that number is expected to balloon to 14 million by 2060. Tax payers would be footing a massive bill for an ineffective drug.
The approval of Aduhelm is a particularly egregious example of how the FDA flaunts actual science in favor of pharmaceutical industry-friendly approvals. But focusing on this one approval as an isolated event is a mistake. Instead, it's part of a troubling pattern at a fundamentally flawed agency - the FDA is structured and funded in a way that helps prescription drug companies more than it helps or protects the public - and a sign of a much larger problem: The way medicinal science is funded and rubber-stamped in this country has less to do with public health than it does with profit.
Until there is a vast overhaul of our scientific funding and approval pipeline, there are sure to be countless instances like Aduhelm, in which drugs are foisted on the public without much benefit - except to the shareholders of drug companies.
One foot in the FDA, one foot in the pharma industry
The current FDA commissioner Janet Woodcock has been accused of having improper relationships with drug companies in the past. Likewise, the former director of the FDA, Dr. Scott Gottlieb, has deep ties to pharmaceutical companies.
But lower down the FDA food chain, the conflicts of interest get even more severe. FDA scientists who shepherd a drug through the approvals process are commonly later given jobs at the companies whose drugs they helped approve. Over 50% of drug reviewers at the FDA eventually take positions in the pharmaceutical industry, according to the limited research available.
Thomas Laughren, for example, once the agency's director of psychiatric products, dismissed evidence that antipsychotics could cause sudden cardiac death, and supported the use of the drugs for a wider range of mental disorders than they were originally intended. After leaving the FDA, he began a consultancy to help drug companies get their drugs approved. He's now the regulatory advisor for a company trying to get psychedelics approved by the FDA for mental illness treatment.
Though there are anti-revolving-door rules on the books to theoretically prevent this exchange between industry and the FDA, they don't have enough teeth to actually stop it - and a recently-proposed law that would attempt to partially fix this problem has stalled in Congress.
Questionable approval history
Based on the agency's history, it is clear that the FDA has a pattern of approving drugs that show little to no efficacy, especially for mental health medications.
Some of the most popular medications in the world right now are SSRIs - antidepressants that theoretically work by preventing the brain from reabsorbing serotonin, and thus increasing serotonin levels in the brain. But clinical trials of these drugs have shown limited results. The first popular SSRI, Prozac (fluoxetine), for example, was built on shaky science. Its manufacturer Eli Lilly was found to have hidden data that suggested the drug could cause extreme agitation in patients, and data that showed that it could increase the risk of suicide. The FDA approved it anyway.
Another blockbuster SSRI, Zoloft (sertraline), was also approved with limited scientific proof that it worked. Of the six studies Pfizer conducted on the drug, four of them showed that Zoloft did not beat placebo in helping depressed patients. Only one of the studies gave sertraline a positive result. The FDA approved the drug anyway. Study after study has suggested that antidepressants may be no more effective than placebo.
Now, nearly 13% of Americans take SSRIs, and that number has likely spiked even higher since the pandemic. Antidepressants are predicted to make drug companies $16 billion a year by 2023. Though the faulty data on SSRIs doesn't mean they're ineffective for every patient - SSRIs not beating placebo could still mean they are working for some in the non-placebo group - it likely means they're overprescribed and that patients haven't been warned adequately of their myriad, often very serious side effects and the severe effects of discontinuing them.
The FDA relying on the faulty science of prescription drug companies, instead of doing their own tests, means that countless Americans are experimenting with medications that may not work for them, or could cause harm.
Misplaced incentives
The problem extends far beyond SSRIs. According to one 2013 analysis, a whopping 90% of new drugs approved by the FDA in the previous 30 years are little or no more effective than existing drugs.
How can the FDA be so bad at its job that 90% of drugs it approves are unnecessary? It's not a matter of a few, corrupt apples at the agency; it's a systemic issue about how science is approved, funded, and ushered through to the market in the United States.
Over the last several decades, the amount of money spent by the US government on drug research has stalled. Meanwhile, the amount spent by pharmaceutical companies on research has skyrocketed. The industry now spends about $83 billion on research and development, a tenfold increase since the 1980s. In one analysis of the New England Journal of Medicine, it was found that 60 of the 73 published drug studies were funded by the pharmaceutical industry, 50 studies included authors who were also employees of the industry, and 37 had accepted money from drug companies.
This means that the impetus for much scientific research these days is not whether a new drug or product will be good for the public, but whether it will make money. One 2010 analysis, written about by Ben Goldacre in the book "Bad Pharma", found that 85% of drug trials produced by the industry gave positive results, whereas only 50% of government-funded studies did.
Drug trials themselves are biased toward profit-making. Drug companies routinely quash studies that show their new drugs to be less effective than old ones, and design the trials to skew results toward positive outcomes. As detailed in "Bad Pharma", analyses show that most research demonstrating SSRIs to be ineffective is simply never published - of 74 studies on antidepressants published between 1987 and 2004, 38 showed the drugs were effective, and 36 showed they were not. All but one of the 38 positive studies was published in a scientific journal, but only three of the negative ones were.
The problem with Aduhelm, as it's been presented in the mainstream media, is of one particularly egregious FDA approval, but reporting and analysis of this scandal misses a much larger and more dangerous reality: The corruption of science in the US is endemic to the way science is funded.
The solution to this bad science will be hard to come by because the problem runs so deep. Schools that conduct scientific research have had their federal aid decreased, and drug companies now fund a larger share of their budgets. Government austerity for science is the norm, whether under Democratic or Republican administrations. And nothing is likely to change when the biggest lobbying group year over year is not Big Oil or Big Tech, but Big Pharma.
The FDA may be filled with well-intentioned scientists who care about public health, but that does not matter as long as the structural issues remain. No matter who leads the agency - as long as it derives some of its budget from prescription drug companies, and as long as it relies mostly on the science of drug companies rather than science untainted by the profit motive (whether performed by the government, non-profits, or universities) - it will remain a fundamentally flawed agency.
The end of corrupt science can only come when we get money out of politics, something that's not likely to happen without massive systemic overhaul. Until then, we should start to look at the science industry more skeptically - not as an unbiased vehicle for truth, but as an industry as susceptible to malfeasance as any other.
When oil companies produce "science" that shows global warming isn't real, we've all learned, rightly, to scoff. Perhaps we need to bring the same reading comprehension to drug science, and ask what ulterior motives lie behind our doctors' prescription pads.
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