Alzheimer’s drug approval by FDA prioritizes profit over public health

  • The agency’s approval of a new drug for Alzheimer’s disease has rightly sparked an uproar.
  • But the problems extend far beyond the drug, and far beyond the FDA: Pharmaceutical science has been corrupted by the pharmaceutical industry.
  • We need to make money from science to have safe and effective drugs.
  • PE Moskowitz is author and director of Mental Hellth, a newsletter on capitalism and psychology.
  • This is an opinion piece. The thoughts expressed are those of the author.

Earlier this month, three scientists from an independent panel from the Food and Drug Administration (FDA) resigned after the agency gave the green light to a drug that scientists had recommended not to approve. The drug, Aduhelm brand aducanumab, is designed to help patients with Alzheimer’s disease, but there is little evidence that it actually works, and monthly infusions of it cost $ 56,000. per year.

“This could be the worst FDA approval decision made,” Aaron Kesselheim, one of the resigning panelists, told The New York Times.

No one on the 11-member panel agreed with drugmaker Biogen’s claim that the drug could help cognitive decline in early Alzheimer’s patients, but the FDA still approved medication. It will now be shipped to more than 900 clinics, according to the New York Times, and within weeks it will be used on patients, prompting government watchdog group Public Citizen to issue a rare call for senior FDA officials to resign. .

“The main beneficiaries of the agency’s action are Biogen and its shareholders, who are undoubtedly delighted with their unexpected profits soon to be reaped from the sale of the drug at the exorbitant but inefficient price of the company”, Michael Carome, director from the Public Citizen’s health research group wrote in a scathing 8-page letter to the FDA.

One of the drug’s biggest problems is its cost: If just one in six Alzheimer’s patients receives the drug, it could cost the US Medicare program $ 56 billion, more than the entire budget. 2019 from the agency. About 5.6 million Americans suffered from Alzheimer’s disease in 2020, but that number is expected to rise to 14 million by 2060. Taxpayers would pay a huge bill for an ineffective drug.

Aduhelm’s approval is a particularly egregious example of how the FDA is flaunting real science in favor of favorable approvals for the pharmaceutical industry. But to focus on this approval as an isolated event is wrong. Instead, it’s part of a troubling scheme of 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 the Sign of a much larger problem: the way medical science is funded and approved in this country has less to do with public health than with profit.

Until there is a vast overhaul of our scientific funding and approval pipeline, there will certainly be countless cases like Aduhelm, in which drugs are imposed on the public with little benefit – except for shareholders. pharmaceutical companies.

One foot in the FDA, one foot in the pharmaceutical industry

Current FDA commissioner Janet Woodcock has been accused of having had inappropriate relationships with drug companies in the past. Likewise, the former director of the FDA, Dr. Scott Gottlieb, has strong ties to pharmaceutical companies.

But further down the FDA food chain, conflicts of interest become even more serious. FDA scientists who guide a drug through the approval process are usually given jobs later in the companies whose drugs they helped approve. More than 50% of drug reviewers at the FDA end up in positions in the pharmaceutical industry, according to the limited research available.

Thomas Laughren, for example, once the agency’s director of psychiatric products, rejected evidence that antipsychotics could cause sudden cardiac death and supported the use of the drugs for a wider range of mental disorders than they did. were initially planned. After leaving the FDA, he started a consulting firm to help drug companies get their drugs approved. He is now the regulatory advisor for a company that is trying to get psychedelics approved by the FDA for the treatment of mental illness.

While there are anti-revolving door rules on the books to theoretically prevent this trade between industry and the FDA, they don’t have enough teeth to actually stop it – and a recently proposed law that would attempt to address it. partially this problem stuck in Congress.

Questionable approval history

Based on the agency’s history, it’s clear that the FDA has a model for approving drugs that show little or no effectiveness, especially for mental health drugs.

Some of the most popular drugs in the world today are SSRIs – antidepressants that theoretically work by preventing the brain from reabsorbing serotonin, thereby 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 fragile science. Its maker Eli Lilly was found to have hidden data suggesting that the drug could cause extreme restlessness in patients, and data showing that it could increase the risk of suicide. The FDA approved it anyway.

Another SSRI blockbuster, Zoloft (sertraline), has also been approved with limited scientific evidence for its effectiveness. Of the six studies Pfizer conducted on the drug, four of them showed that Zoloft did not beat the placebo in helping depressed patients. Only one of the studies tested positive for sertraline. The FDA approved the drug anyway. Study after study, it has been suggested that antidepressants may not be more effective than placebo.

Today, nearly 13% of Americans take SSRIs, and that number has likely increased further since the pandemic. Antidepressants are expected to net drug companies $ 16 billion a year by 2023. While the flawed data on SSRIs doesn’t mean they’re ineffective for all patients, SSRIs that don’t beat placebo could still mean that they are ineffective. ‘they work for some in the non-placebo group. – this probably means that they are over-prescribed and that patients have not been adequately warned about their myriad of often very serious side effects and the serious effects of stopping them.

The FDA relying on the flawed science of prescription drug companies, instead of doing their own tests, means that countless Americans are experimenting with drugs that may not work for them or that could cause them harm.

Misplaced incentives

The problem extends far beyond SSRIs. According to a 2013 analysis, as many as 90% of new drugs approved by the FDA in the past 30 years are little or no more effective than existing drugs.

How can the FDA be so bad at its job that 90% of the drugs it approves are unnecessary? These are not a few corrupt apples at the agency; it’s a systemic issue about how science is approved, funded, and brought to market in the United States.

Over the past decades, the amount of money spent by the US government on drug research has stagnated. Meanwhile, the amount spent by pharmaceutical companies on research has skyrocketed. The industry now spends around $ 83 billion on research and development, a ten-fold increase since the 1980s. In an analysis from the New England Journal of Medicine, 60 of the 73 published drug studies were found to be funded. by the pharmaceutical industry, 50 studies included authors who were also employees of the industry and 37 had accepted money from pharmaceutical companies.

This means that the motivation for most scientific research these days is not whether a new drug or product will be good for the public, but whether it will make money. A 2010 analysis, written by Ben Goldacre in the book “Bad Pharma,” found that 85% of industry-produced drug trials yielded positive results, while only 50% of government-funded studies did.

Drug trials themselves are biased towards profit. Pharmaceutical companies routinely cancel studies that show their newer drugs are less effective than old ones, and design trials to bias the results toward positive results. As detailed in “Bad Pharma”, the analyzes show that most of the research showing that SSRIs are ineffective is simply never published – of 74 studies of antidepressants published between 1987 and 2004, 38 showed that the drugs were effective and 36 have shown that they are not. All but one of the 38 positive studies were published in a scientific journal, but only three of the negative were.

The problem with Aduhelm, as portrayed in mainstream media, is a particularly egregious endorsement by the FDA, but the reporting and analysis of this scandal misses a much larger and more dangerous reality. : Science corruption in the United States is endemic to the way science is funded.

The solution to this bad science will be difficult to find because the problem runs so deep. Schools that conduct scientific research have seen their federal aid cut, and drug companies now fund more 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 can be filled with well-meaning scientists who care about public health, but that doesn’t matter as long as the structural issues remain. It doesn’t matter who runs the agency – as long as it gets part of its budget from prescription drug companies, and as long as it relies primarily on the science of the drug companies rather than science untainted by profit. (whether done by government, non-profit, or universities) – it will remain a fundamentally flawed agency.

The end of corrupt science can only come when we take money out of politics, which is unlikely to happen without a massive systemic overhaul. Until then, we should begin to view the science industry with more skepticism – not as an impartial vehicle of truth, but as an industry as susceptible to malfeasance as any other.

When the oil companies produce “science” that shows global warming is not real, we have all rightly learned to laugh. Maybe we need to bring the same reading comprehension to drug science and ask ourselves what ulterior motives are behind our doctors’ prescription books.


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