I take a lot of pharmaceutical medications. For heart problems, cholesterol, and other assorted maladies. I rely on both my doctors and the FDA to ensure they are safe and effective.
Of course I know that the process is imperfect, the evidence for safety and effectiveness is sometimes sketchy, and I have even dropped using some of the drugs because I don’t believe the benefits are worth the cost. I read the disclosures (mostly) and have even looked at studies that “proved” the effectiveness of newer drugs.
In other words, I don’t blindly trust the process, but my cynicism is not unbounded. There really are wonder drugs out there that save or improve lives, and I am not a hater of pharmaceutical companies. They genuinely do save lives. As profitable as they are, compared to Apple or Google they make peanuts and provide great social good. Apple alone made 3x as much in profits as the entire pharmaceutical industry.
But the FDA’s process is sketchy and getting more politicized, or at the very least more obviously so. And the example of how Biogen’s Alzheimer’s drug Aduhelm has gone through the approval process proves it.
Alzheimer’s is a terrible disease. It robs people of their personality and eventually their humanity. It can turn the most intelligent and vital people into shells of their former selves, and cracking the code for how to treat it is rightfully a top priority. Scientists have theories for what causes the decline, but both diagnosing and explaining the course of the disease are still mostly mysterious. But with the aging of Western populations the burden of the disease is increasing every year.
Biogen claims to have a drug that will slow the process. The problem is that if it does anything at all, and that is in question, it doesn’t do much. Yet the FDA not only approved it despite Biogen’s own studies indicating that it didn’t work, it did so over the objections of its independent advisory committee.
The committee’s objections were so strong that 3 of the members resigned in disgust. An 18 month Congressional investigation found startling irregularities in the process of approving the drug.
The Committee on Oversight and Reform and the Committee on Energy and Commerce found that the collaboration between the FDA and Biogen in the approval process of the drug “exceeded the norm in some respects.”
Biogen had initially discontinued Aduhelm’s clinical trials in March 2019 after an independent committee found that it probably would not slow the cognitive and functional impairment – the decline in memory, language and judgment – that comes with Alzheimer’s. But in June 2019, the FDA and Biogen started a “working group” to see whether the effort could be saved.
The investigation found that the FDA and Biogen engaged in at least 115 meetings, calls and substantive email discussions from July 2019 to July 2020, including 40 meetings to guide Aduhelm’s potential approval. There may have been even more meetings, but the committees say the FDA failed to follow its own documentation protocol.
The agency then collaborated with Biogen to draft a document used to brief an independent advisory committee that met in November 2020. The trial results were mixed, with only one showing a small benefit to patients.
At that meeting, none of the committee’s members voted to say that the studies presented strong evidence that the drug was effective at treating Alzheimer’s.
The meeting was unusual, according to one former FDA adviser who had sat on the committee for several years. Dr. Aaron Kesselheim told CNN in 2021 that the relationship between the FDA and the company was out of the ordinary.
“There was a strange dynamic compared to the other advisory committee meetings I’ve attended,” the professor at Harvard Medical School said. “Usually, there’s some distance between the FDA and the company, but on this one, the company and the FDA were fully in line with each other in support of the drug.”
All this effort was put into ensuring the approval of a drug that the company almost abandoned due to the initial failure of the clinical trials–trials that had been halted due to the failure of the drug to show any benefit. It was only after a later statistical analysis showed some modest benefit that they pushed ahead with trying to get approval from the FDA. The FDA obviously worked hard to ensure approval despite the sketchiness of the results.
Big money was involved.
The investigation found that Biogen planned an aggressive marketing campaign to launch the drug, intending to spend more than $3.3 billion on sales and marketing between 2020 and 2024 – more than 2½ times what it spent to develop Aduhelm.
Dementia, including Alzheimer’s, is one of the “costliest conditions to society,” according to the Alzheimer’s Association. In 2022 alone, Alzheimer’s and other dementias cost the US $321 billion, including $206 billion in Medicaid and Medicare payments, the association says.
Aduhelm’s cost to patients and to Medicare would be significant, the new report says. It was one of the key factors behind a big increase in Medicare premiums in 2022, according to the Centers for Medicare and Medicaid Services.
In anticipation of “pushback” from providers and payers, the report says, Biogen also prepared a narrative to sell the value of the drug.
The fact that Biogen wanted to make big bucks isn’t a surprise. That is the company’s job. And it is hardly surprising that they would hype the product–that is what businesses do. It is the FDA’s job to ensure that the pecuniary motives of the company aren’t in conflict with the benefits to patients and society, and they clearly failed in this case. The company knew that the safety and effectiveness of the drug was questionable. So did the independent panel of experts. It was the FDA bureaucracy–a creature of government–that made the final decision.
The FDA also approved the drug for “people with Alzheimer’s disease,” a far broader population than was studied in Biogen’s clinical trials.
Internal documents from the company said that Biogen accepted this broader indication “despite internal reservations about the lack of evidence of clinical benefit for patients at disease stages outside of the clinical trials and an unknown safety profile,” the report says. Leaders expressed concern that the company could lose credibility, and it developed a communications strategy to deal with the “anticipated fallout,” the report says.
This isn’t just a story about the approval of one drug. Processes can fail even in good systems, although a failure this obvious and of such magnitude rightly deserved a Congressional investigation. There are other examples of cases where government officials have gone off the reservation to push drugs of questionable merit.
Vinay Prasad has been sounding the alarm about how both the White House and the CDC have been relentlessly pushing Paxlovid as a treatment for COVID, despite relatively little evidence it works at all, and no evidence that it works for people who have been vaccinated. All those cases of prominent vaccinated figures in government getting repeat cases of COVID and reemergence of the disease after it being supposedly cleared from their systems involve Paxlovid. It appears that in many cases the course of the disease is extended, not shortened when the drug is used in vaccinated people. Yet the government pushes it hard.
Perhaps because they bought a ton of it, even before clinical trials were completed?
Now do Biden white house and Paxlovid
They purchased the product BEFORE trial results were available
Trial results still DO NOT EXIST for vaccinated people, yet Biden admin pushes relentlessly to dispense the drug
Who would do that with public funds? https://t.co/sLxtbdF2T9— Vinay Prasad MD MPH (@VPrasadMDMPH) December 29, 2022
Prasad has also been raising the question of why the FDA, the CDC, and the public health establishment has refused to do randomized controlled trials for anything related to COVID. 3 years into the pandemic the government remains uninterested in the question of whether masks actually work; their “trials” have been extremely weak observational studies rather than RCTs. This is a pattern, based upon the ridiculous assertion that doing RCTs would be unethical because, should masks work, the unmasked would have been exposed to greater risk unnecessarily.
Ridiculous on its face. Finding volunteers to do these studies unmasked would hardly be a problem, and they have done RCTs on much more dangerous tests. Pretty much every RCT involving a medical device presents a greater risks to patients.
This is a massive news story
Masks needed cluster RCT
Lockdowns needed public debate
Boosters need RCT
Vax in people who had COVID is unproven
We needed dialog, but it was shut down.
MSM thinks this doesn't matter– that is sad, and reflects their blind spot https://t.co/rqGEWMPA2l— Vinay Prasad MD MPH (@VPrasadMDMPH) December 30, 2022
All of these examples point to a significant problem: a commitment to obtaining pre-determined results regardless of the evidence. Weak or non-existent evidence is no barrier to getting the desired result.
Why? We can only speculate, but money is almost certainly involved. It’s hard to imagine another motive. There is a revolving door linking FDA bureaucrats to the companies they regulate, and being on the right side of an approval process can mean a lucrative job in the future.
Again, this is hardly shocking. Money motivates people for obvious reasons. But before you shrug, consider this: Western societies run largely on trust, and the success of our system has rested on a reasonably good judicial system, reasonably ethical business practices, and reasonably ethical government. It has never been perfect because…human beings…but compared to most places in the world where a bribe gets results, we have been blessed with relatively less corruption.
In many countries bribes and personal loyalties determine nearly every outcome. Here we can generally expect that people will do their jobs, and actually punish people who don’t. We don’t generally bribe police officers to get out of tickets, and we aren’t generally pulled over in order to pay for a nice dinner for the cop. That’s not true most places.
We actually expect people in positions of power and responsibility to be responsible.
That system of trust is breaking down, and with it will come societal breakdown. If our government becomes a protection racket all bets are off.
Join the conversation as a VIP Member