Seeking Leqembi's approval at all costs

Part III: Silencing dissenting viewpoints

When it comes to last Friday’s advisory meeting over Leqembi I’ve covered some of the more clinical/scientific aspects with this immunotherapy, and why the warm reception that it is receiving does not appear to be warranted.

Leqembi is likely to see full, traditional FDA approval. But can anyone explain what it actually does?

What exactly is "clinically meaningful" when it comes to Leqembi?

But as mentioned in the last part of Part II, there was something interesting, and something rather concerning I noticed with some of the remarks made by some of the advisers, as well as some of the advocates of Leqembi.

It’s remarks that were all-too familiar when it came to the COVID vaccines, such that any viewpoint, any critique, or any concern raised that was counter to the narrative of Leqembi’s safety and efficacy profile was considered a bad-faith attempt of downplaying the actual usefulness of Leqembi.

I saw several phrases used, including the phrase “sowing seeds of doubt” or “misinformation”. Here, anyone who dared to even question what a CDR-SB difference of 0.451 actually means in practice was discrediting Leqembi and doing harm to those living with Alzheimer’s who are seeking any sort of treatment.

I pointed out yesterday that Joanne Pike (Speaker #5), who is CEO and president of the Alzheimer’s Association, is a clear example of this approach of suppressing any real concerns over Leqembi’s safety and efficacy (timestamped below).

Keep in mind that Pike comments that the Alzheimer’s Association received 1.06% of their 2022 revenue from biotech companies. Pike argues that most of the funding comes from individuals, although it’s hard to overlook the fact that she mentions the Alzheimer’s Association received $465,000 from Eisai in 2022.

This issue isn’t just related to Pike and the Alzheimer’s Association, as several of the non-profits who have spoken in support of Leqembi in the Open Public Forum also received funding from biotech companies including Eisai.

However, it does raise a serious conflict of issue with some of these speakers. I won’t argue that every single person who receives funding from pharmaceutical companies will inherently vote in favor of a drug’s approval. However, I also can’t deny that the burden of proof is astronomical to argue that this isn’t the case.

In this case, the real concern comes over Pike’s remarks about those who raise questions over how to interpret the primary endpoint results for Leqembi:

“The most disturbing aspect of some discussions about clinical meaningfulness are those speculating about, and often misinterpreting the meaning of changes on a scale like the CDR- Sum of Boxes, to diminish the importance of these treatments to those who have early Alzheimer’s.”

Pike alleges those who question what the CDR-SB scores may actually translate to in the real world are using qualitative terms, and are overlooking the fact that Leqembi may buy people 6 more months of “rich” time with their loved ones.

And yet Pike herself are using these terms qualitatively. What exactly is the “rich” life that Pike is referring to, as not all patients will present with the same symptoms of Alzheimer’s. I think Dr. Murphy wouldn’t see her grandmother’s episodic delusions of persecution, which have greatly exhausted her mother, as being a “rich” life, with Leqembi only serving to prolong the manifestations of delusions and the burden it puts on Dr. Murphy’s family.

And does a “rich” life entail the risk of brain bleeds, brain swelling, and death, or the need for either weekly or biweekly injections for the rest of one’s life at the cost of around $27,000 annually to either the patient or taxpayers by way of Medicare, which also includes routine visits for brain imaging to examine for serious adverse reactions that may go undetected or undiagnosed?

To put this into perspective, some estimates suggest that if Leqembi was to be covered by Medicare this would lead to a cost of over $5 billion dollars a year. Again, that’s your money being used to fund a drug to which no one can provide clear, transparent evidence of safety and efficacy.

Pike also seems to speak qualitatively over the questionable results of Adulhelm whereas the results are apparently clear over Leqembi’s effectiveness.

But as Pike and many others in the meeting have remarked (Speaker #7 may be good example as well), the real issue has been the fact that many people have raised serious doubts about this drug’s actual safety and efficacy profile. In doing so, these people are downplaying these drugs, and raising unnecessary doubts when all these people want are hope and optimism.

Thus, to question a drug is to cause unneeded harm.

It’s interesting to see this sort of language manifest in the advisory meeting, but I’m also unsurprised.

It is now the approach through emergency use and accelerated approval that both pharmaceutical agencies, as well as regulatory agencies such as the FDA, can weaponize the public’s eagerness for a treatment.

Speak of a treatment for a disease to which no treatment appears to exist, weigh the want and need of a treatment heavily over the public, and then let the public discourse suppress any real criticisms over safety and efficacy.

It’s here, through these non-profits and advocacy groups, as well as through several clinicians, where a disingenuous game is being played.

In the same ways that those who were critical of lockdowns were called “grandma killers”, anyone who dares question the safety and efficacy of Leqembi are those who clearly don’t want to see an end to Alzheimer’s. Otherwise why criticize the only hope for a treatment? Isn’t it better to have something rather than nothing?

Again, these arguments are completely disingenuous and seem to take an all-or-nothing approach to these treatments rather than weighing real concerns. If one questions what is exactly clinically meaningful with Leqembi, the response is to not remark that these people just don’t understand what these words mean, or that they don’t understand the science.

Why is it that neither the ones making the drugs and conducting the clinical trials, nor those who are responsible for regulating and approving of the drug, able to provide clear, transparent responses? Why is it that personal testimonials seem to speak of effects that are counter to what the drug is actually supposed to do? Isn’t any remarks of “improvement” misinformation by way of speaking of something that has not actually been measured, and is actually counter to the results provided?

But no, it is those who ask questions, those who seek transparency and answers, who are the ones sowing seeds of doubt and must not be taken seriously.

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We’re entering into a new era of drug approval, where it is no longer about the science, but more about the narrative that obfuscates the actual data. All one has to do when asking pertinent questions is to obfuscate those concerns as being against the cause, or bringing forth unnecessary skepticism. Leverage narratives and deceptive language at opponents rather than hard data.

But what also seem to be emerging is the concept of validation by way of authorization. That is, any drug who receives approval becomes by default safe and effective. Otherwise, why would the drug become approved? It’s a reliance by these pharmaceutical manufacturers that the public rely on heuristics rather than nuanced, critical thought in discerning that an approved drug isn’t inherently safe or effective.

It is approved, therefore it must work…until it doesn’t and many cause serious undue harm.

Consider that early remarks of Leqembi’s accelerated approval were lukewarm. It’s not hard to find several articles out there who have argued that Leqembi’s results are not that different than Adulhelm’s.

From verywellhealth. Interestingly, this article comes with a “fact checked” stamp of approval. I’m curious if this would lead to some form of cognitive dissonance among those who rely on “fact checked” information who also are critical of Leqembi dissenters.

And in a manner of consistency, the unanimous remarks by the FDA’s committee advisors seem to run counter to the perspective of other regulatory agencies abroad.

Keep in mind that Adulhelm’s accelerated approval was met with rejection by the EU over lack of safety and efficacy data:

From Reuters and republished in yahoo!news

As reported in the 2021 Reuters article:

The European Medicines Agency noted that although Aduhelm reduced amyloid beta in studies, the link between this effect and clinical improvement in the disease had not been established.

The Cambridge, Massachusetts-based company's shares fell 4.2% in premarket trading on the news. Biogen said in a statement it would seek a re-examination of the agency's opinion.

The results from the main studies of the drug were conflicting and did not show that Aduhelm was effective in treating adults with early stage Alzheimer's, the EMA said.

But as news of the pathway towards full, traditional approval spread, European regulators still seemed un-phased, issuing similar remarks over lack of efficacy and safety data, as well as concerns over the high cost of this drug, as reported in Reuters.

From Reuters

In Europe, where cost-conscious countries rigorously weigh new drugs before adopting their use, nine neurologists and researchers across six countries told Reuters lecanemab is unlikely to be widely used if approved. Their views underpin analyst estimates suggesting Europe will be a small market for the drug.

Some doctors said its effect on the disease may not be clinically meaningful enough when weighed against the risk of brain swelling, its likely high price, and limited personnel and resources to administer twice monthly infusions and monitor for brain swelling with MRI scans.

In contrast to this strange dichotomy shown between Aduhelm and Leqembi, European agencies seem to be viewing these drugs in a similar manner.

So how is it that there are two schools of thought forming over these therapeutics, where here in the US the controversies over Adulhelm have been completely overlooked while Leqembi is viewed with optimism, while European scientists and agencies don’t see any difference between these two drugs?

This apparent lack of consistency is rather telling, and the fact that many people such as Pike and other Leqembi proponents can remark that one drug is controversial and the other shows clear benefit should exemplify they sort of malfeasance likely taking place.

Again, I remind readers that there’s a cost of wanting a treatment at all costs. There’s no doubt many people would like to see diseases be eradicated, but understand that there are those who will prey upon your want of a treatment to cause you to overlook questionable data. Don’t fall into the trap of having your wants be weaponized against you.

As of now, the FDA still not has put out any information about full, traditional approval being reached for Leqembi, although I wouldn’t be surprised if that is the end result, because this is how we enter a new era of drug approval- not with data, but with narratives.

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