Latest FDA Scandal Further Proves Why We Can’t Trust Them

I take many pharmaceutical medications. Heart problems, cholesterol, and other maladies. Both my doctors and FDA are reliable in ensuring that these medications 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 have read most of the disclosures and even looked at studies. “proved” The effectiveness of newer drugs.

In other words, I don’t blindly trust the process, but my cynicism is not unbounded. There are miracle drugs that can save lives or improve them, and I don’t hate pharmaceutical companies. They truly do save lives. Although they may be profitable, they provide great social benefits and make peanuts.  Apple alone was able to make 3x more profits than 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 takes away a person’s personality and ultimately their humanity. It can cause people to become shells of their former selves, even the most intelligent and vibrant. So it is an important priority to discover how to treat it. While scientists have many theories as to why the disease is declining, they are still unable to diagnose or explain the cause. The disease burden is rising with increasing aging in Western societies.

Biogen claims they have a drug to slow down 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 Committee on Energy and Commerce both found that collaboration between Biogen and FDA was essential in the drug approval process. “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. However, in June 2019, Biogen and FDA began to work together. “working group” To see if it 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. The committees believe there were more meetings than that, but the FDA did not follow its own documentation protocol.

Biogen collaborated with the agency to create a document that would be used to brief an independent advisory panel, which met in November 2020. Results from the trials were mixed. Only one showed a slight benefit to patients.

None of the participants were able to attend that meeting. committee’s members voted to say that the studies presented strong evidence that the drug was effective at treating Alzheimer’s.

According to a former FDA adviser, the meeting was not common. He had served on the committee for many years. Dr. Aaron Kesselheim told CNN in 2021 It was unusual for the FDA to have a relationship with the company.

“There was a strange dynamic compared to the other advisory committee meetings I’ve attended,” Harvard Medical School’s professor stated this. “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. They were able to obtain FDA approval only after statistical analysis revealed some modest benefits. Despite the sketchy results, the FDA worked tirelessly to get approval.

There was huge money 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.

Aduhelm is a key driver of Medicare premiums. It costs $56,000 per annum.

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 the major factors behind a big increase The report shows that Medicare premiums will rise to $202 in 2022 according to the Centers for Medicare and Medicaid Services.

In anticipation “pushback” The report states that both payers as well as providers provided feedback. Biogen also wrote a narrative to help them sell the drug’s worth.

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 drug’s safety and effectiveness were questionable. The independent panel also knew this. It was the FDA bureaucracy–a creature of government–that made the final decision.

The FDA also approved this drug “people with Alzheimer’s disease,” a far broader population than was studied in Biogen’s clinical trials.

According to company documents, Biogen had accepted the 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,” According to the report. Leaders were worried that the company would lose credibility. The company devised a communications strategy for dealing with this. “anticipated fallout,” According to the report.

This isn’t just a story about the approval of one drug. Even in the best systems, processes can fail. However, a failure of this magnitude and obvious merited a congressional investigation. Other cases show government officials pushing drugs with questionable merit.

Vinay Prasad has been warning about the CDC and White House pushing Paxlovid to treat COVID. There is little evidence of its effectiveness and it doesn’t work for those who have been vaccinated. Paxlovid is the reason for all those instances of government officials who have been vaccinated and then get COVID again. The drug is not effective in shortening the time it takes for the disease to progress in some cases. The government insists on it.

Maybe because they bought tons of it before clinical trials were complete?

Do you want Paxlovid and a Biden white house?
The product was purchased BEFORE the trial results were available
Trial results are not yet available for vaccine-eligible people. However, Biden administration continues to push relentlessly for the drug’s distribution
Who would ever do that with public money? https://t.co/sLxtbdF2T9

— Vinay Prasad MD MPH (@VPrasadMDMPH) December 29, 2022

https://twitter.com/VPrasadMDMPH/status/1608529774162464772?ref_src=twsrc%5Etfw

Prasad also raised the question as to why the FDA, CDC and the public health establishment have refused to conduct randomized controlled trials on COVID. The government is still uninterested in whether masks really work three years into the pandemic. “trials” have been extremely weak observational studies rather than RCTs. This pattern is based on the absurd assertion that RCTs would be unethical since, should masks fail, those unmasked would have been exposed unnecessarily to greater risk.

It is absurd on the surface. It would be difficult to find volunteers to perform these studies unmasked. They have also done RCTs for much more dangerous tests. Every RCT that involves a medical device poses greater risks for patients.

This is huge news!
Cluster RCT required for masks
Public debate required on lockdowns
Boosters require RCT
The presence of vax in patients with COVID is not supported
Dialog was needed, but it was cut off.
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

https://twitter.com/VPrasadMDMPH/status/1608654334191104001?ref_src=twsrc%5Etfw

These examples highlight a serious problem: the need to be committed to achieving pre-determined results regardless if there is evidence. It doesn’t matter if there is weak or insufficient evidence to get the desired result.

Why? Although we can only speculate, it is likely that money is involved. It’s hard to imagine another motive. There is an alternative. revolving door Linking FDA bureaucrats and the companies they regulate can lead to lucrative jobs in the future.

This is not surprising. People are motivated by money for obvious reasons. Be careful, though. Trust is the cornerstone of Western societies. The success of Western societies rests on trust. A reasonably good judicial and business system and an ethical government are just a few examples. 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.

Nearly every outcome in many countries is determined by bribes and personal loyalty. 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.

People in positions of power or responsibility are expected to be accountable.

The trust system is on the verge of collapse, which will cause social breakdown. All bets are off if our government becomes a protection racket.

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