The FDA Chooses Big Pharma Over Dying Seniors

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Over the past few months, pharmaceutical companies have been seen as legit heroes. The incredible speed at which researchers developed vaccines for COVID-19, and then politician’s speed of approving them for the public, and then the corporation’s speed at pumping out vaccines has all kind of collected into “Yay Pfizer! Yay Moderna!” Like, we’re all talking about what team we are — I’m Team Johnson & Johnson! Like it’s a Harry Potter house. Which I guess is why I had no problem getting Johnson & Johnson. I’m already a Slytherin, apparently. All I know about Harry Potter is that means I’m fucking evil. Why does that house even exist? Just get rid of it, Dumbledore, Jesus. Please don’t answer that in the comments. I don’t actually care.

And look, I’m not immune (haha) to the joy of being vaccinated and being thankful for that and wanting to goof around. But I’ve bit my tongue for months now because…I hate the pharmaceutical industry. I am SO happy to have the Johnson & Johnson vaccine, and also I fucking hate Johnson & Johson. I hate Pfizer. I hate Moderna. They’re evil, awful companies run by evil, awful people who would stab your grandmother to death before giving her her inhaler at only 100% markup. They take publicly funded research and then patent it and sell it back to Americans at insane prices, like a 30-cent malaria drug they sell to Americans for $93. Then they lie to Americans that they’re spending the extra money on research when they’re actually spending that money on getting richer, plus marketing and lobbying efforts to stop the government from trying to limit their price gouging, and the average American believes their lies because we’re all in a weird Stockholm syndrome with our healthcare market.

You know what, fuck it, don’t take my word for it. Watch Representative Katie Porter make the CEO of pharmaceutical company say it.

Queen. Are we still saying “queen”? Is that cringe now? Whatever. Good job, Representative Porter, you’re cool as shit.

Anyway, I’m talking about how bad Big Pharma is today not because of that absolute murder Rep Porter committed, but because of another bad thing that happened: the FDA has just approved a new Alzheimer’s drug. When I first saw that headline, I was overjoyed — Alzheimer’s and other forms of dementia are some of the absolute worst diseases on the planet. I’ve lost family members to it and there’s just no way to describe the feeling of seeing a bright, sharp person descend into a lifeless husk of a body who looks straight through you with no recognition. We need good research, and we need big breakthroughs, and we need new therapies. Until recently there were only five drugs approved to treat Alzheimer’s, with the most recent being approved 18 years ago.

Unfortunately, this is not the savior drug people are desperate for. Biogen’s Aduhelm, actual drug name aducanumab, is a monthly injection that reduces the amyloid proteins that build up in the brains of Alzheimer’s patients. Sounds good, right? Well…you may be surprised to learn that after twenty years of research, scientists have found little to no evidence suggesting that reducing those deposits actually slows, stops, or reverses cognitive decline. As far as scientists can tell, those deposits may just be like the blue skin people get when they consume too much colloidal silver — the skin color may help doctors diagnose a person with argyria but giving the patient a spray tan isn’t going to improve their health.

So in trials for Aduhelm, the drug was an abject failure and research was discontinued in early 2019. But later that year, Biogen and their partner Eisai massaged the data until they thought they had something of statistical significance for a specific subset of the patients in the earlier trials who received a larger dose of the drug and showed a possible 23% reduction in cognitive decline compared to a placebo group.

If you’ve been watching my videos, you should have a p-hacking alarm bell going off in your head right about now. The short explanation for p-hacking is when you gather a bunch of data, don’t get the result you want, so you go through it until you find something weird and pretend THAT was the thing you were looking for, even though something weird always pops up when you gather a whole bunch of data. For more information, feel free to check out these previous posts on how walking your dog doesn’t give you COVID, drinking milkshakes for breakfast doesn’t make your memory bad, having a sexy wife doesn’t make men happier, cookbooks aren’t making us fatter, R-rated movies don’t make humans emit more isoprene, fish oil doesn’t make parents stop arguing, cell phones (still) don’t cause cancer, and of course, women do not guard their men from sexy ovulating werewolf hussies.

Anyway, the good news is that a pharmaceutical company can hack their p’s all they want but that’s not how you get FDA approval. To get FDA approval, they had to do a new trial that started in January of 2020. That trial not only showed little to no benefit, but a new possible safety concern in the form of abnormalities that showed up in the brains of patients dosed with Aduhelm compared to the placebo group, resulting in some patients experiencing “severe symptoms, including confusion, disorientation, gait disturbance, ataxia, visual disturbance, headache, nausea, falls, and blurred vision. The FDA’s statistical review also suggested evidence of potentially greater falls in the high-dose cohorts.”

So, when the FDA considers new drugs they form an advisory group of people with relevant expertise but no conflicts of interest. Of the 11 members of the committee, ten voted against approval of the drug and one was unsure. The FDA approved Aduhelm anyway, leading three of the advisors to resign in protest after years of service.

Biogen immediately announced they’d be shipping the drug in a few weeks, and oh yeah also while everyone expected a year of the drug to cost $10-25,000 it was actually going to cost $56,000. Wholesale.

In 2020, Biogen spent $4 million lobbying government agencies like the FDA’s Department of Health and Human Services. The drug is predicted to generate tens of billions of dollars in revenue, much of it coming from taxpayers who are covering Medicare costs for seniors. Quite the good trade.

And at the end of the day we come to the absolute saddest part of all of this: families who desperately want to fix their loved ones who, every day, recognize them less and less. Families who will do anything to try to slow or stop the cognitive decline, including scrounging up every penny they can find — Medicare will cover some of the cost but patients will still be out of pocket for thousands, maybe tens of thousands of dollars — to pay for a new drug that experts say probably won’t help. It’s all a big scam, just like when I talk about alternative medicine scammers who get desperate, dying people to pay for homeopathy or reiki for incurable cancer. Only in this case, the US government is a crucial part of the scam.

Anyway, if you have a loved one with Alzheimer’s, please know the truth about Aduhelm. Protect yourself and protect the patients who can’t protect themselves, since the FDA isn’t doing it for us.

Rebecca Watson

Rebecca is a writer, speaker, YouTube personality, and unrepentant science nerd. In addition to founding and continuing to run Skepchick, she hosts Quiz-o-Tron, a monthly science-themed quiz show and podcast that pits comedians against nerds. There is an asteroid named in her honor. Twitter @rebeccawatson Mastodon Instagram @actuallyrebeccawatson TikTok @actuallyrebeccawatson YouTube @rebeccawatson BlueSky

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One Comment

  1. I am a family practitioner. I am already having daylight nightmares about having to explain to my patients why I do not want to prescribe this drug.

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