Aducanumab Approval, Part 2: Dirty Drug Dealings

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Yves here. We’re doing a bit of catchup by featuring some significant stories that were still crowded out a bit due to the competing news plus the Fourth of July tuneout. One is on the super dodgy approval of the big ticket, very dubious effectiveness Alzheimer’s drug Aducanumab. And “big ticket” is no understatement; the annual cost is anticipated to be $56,000. This post gives a fine, if disheartening, account of how this rancid regulatory sausage was cooked up. The central element is the successful suborning of the Alzheimer’s Association, which feasts on Big Pharma donations, to throw its weight in a major way behind this effectively unproven yet costly medication.

Readers of a certain age will recognize the parallel to the AARP, which once was feared and respected advocate of senior citizens’ interests. The AARP now regularly stands behind all sorts of grifting, as long as it’s been prettied up with sufficiently skilled PR.

By APeticola. Originally published at Health Care Renewal

  1. of a huge campaign by a company (Biogen) that would not accept the failure of its drug
  2. and

  3. of pressure from patient organizations like the Alzheimer’s Association (which receives major money from pharma, including Biogen and its Japanese partner, Eisai).

The company campaign began in spring 2019, after its Phase 3 trials were stopped for futility after an interim review. A long, detailed, and excellent STATnews article published this week, drawing on insider sources, tells a fascinating but troubling story. The last-ditch effort to get approval was originally called “Operation Phoenix,” but was re-titled “Operation Onyx.” Biogen managed to get Billy Dunn, Director of the Office of Neuroscience at the FDA, on their side, to the point that he worked closely with them to provide a roadmap for approval, very inappropriately.

After the groundwork was laid for an approval of aducanumab despite the negative advisory committee recommendation, and prior to the announcing of a final decision, the patient organization campaign was carefully timed. In early May, the Alzheimer’s Association launched a big campaign seeking to build grassroots support for drug approval. The “More TIme” campaign worked to pull at heartstrings with celebrity endorsements and poignant personal stories. Full-page ads were taken out in the Wall Street Journal and USA Today, and focused on what “more time” would mean to Alzheimer’s patients and their families. There were google search ads, Facebook and Twitter and Instagram and LinkedIn posts. The campaign succeeded in getting over a million people to express support in petitions.

After the approval, the Alzheimer’s Association spoke of victory:

As the first FDA-approved drug that delays decline due to Alzheimer’s disease, the approval of aducanumab (Aduhelm™) is a victory for people living with Alzheimer’s and their families.

Comments on articles including this one give the flavor of the passion with which some people want to try this unproven therapy.

Denying a medicine which might work is far more worse than approving one that might not work! Do you agree in the case of Alzheimer’s?

The negativity of these old fashion mentality is what has driven new discoveries to a halt. I don’t suffer from Alzheimer’s nor know anyone close to have been dx w it but we need to start somewhere. Prescribing the pharma will only help w research. Get in line MD.

Alzheimer’s is a horrible disease. If the medicine has a chance of success then prescribe it.

And public officials seem to be buffaloed. A Politico article said that not only are public officials mute about the approval, they are hesitant even about making a fuss about the pricing (about which more in another post):

[Politicians are] worried they’ll be seen as dashing desperate patients’ hope for an Alzheimer’s treatment — even one that may provide little or no benefit. The FDA’s controversial approval of Biogen’s drug, known as aducanumab or Aduhelm, has caught both political parties flat-footed …Everyone is a bit terrified by Alzheimer’s, so the average person hears about the FDA approval of a treatment, and they don’t know about the controversy over whether it works or not,” said Craig Garthwaite, a health economist at Northwestern University’s Kellogg School of Management who lambasted FDA’s Aduhelm approval. “They hear there’s a new treatment and, that’s great, it’s a sign of hope. Do you want to be the politician who says, ‘I want to take that away from you?’”

Evidently, the public opinion campaign with its drumming up of support for this bogus drug has had its desired effect, creating cowardice to speak about the realities. Subsequent to the publication of the Politico article, two senators did speak out about pricing, but were careful to praise the drug:

Even as they criticize the price, however, Cassidy and Warren still stopped short of directly criticizing Biogen. They offered praise for the drug’s approval, too, calling it a “historic, watershed moment” in the history of the disease.

Public Citizen – who does not have to get elected – did not share this hesitancy. Their long public letter to HHS Secretary Xavier Becerra – which I recommend reading in full – begins as follows:

Public Citizen is writing to express its outrage over the Food and Drug Administration’s (FDA’s) indefensible decision to approve Biogen’s aducanumab (Aduhelm) for treatment of Alzheimer’s disease despite the lack of evidence that the drug provides any meaningful clinical benefit plus the fact that the drug has a well-documented risk of potentially serious brain injury. The FDA’s decision to approve aducanumab for anyone with Alzheimer’s disease, regardless of severity, showed a stunning disregard for science, eviscerated the agency’s standards for approving new drugs, and ranks as one of the most irresponsible and egregious decisions in the history of the agency.

They go on to ask for resignation of key officials in approving aducanumab, including FDA acting head Janet Woodcock and Billy Dunn. They also ask that the Office of the Inspector General for HHS investigate the relationship and “close collaboration” between the FDA and Biogen prior to Aduhelm approval. In addition, they want rescission of the bogus approval:

You should direct the next Acting FDA Commissioner to consider whether the agency’s approval of Biogen’s BLA for aducanumab should be withdrawn.

Those who pushed for approval seem eager to foreclose any discussions of rescission. In an interview, there was this question and answer with Acting FDA Head Janet Woodcock:

Question: “There’s been some reaction that every time this criticism comes up, the FDA just dismisses it outright and doesn’t really meaningfully engage on it —doesn’t do soul-searching. … Should the FDA do some soul searching? Should you and the FDA be trying to respond more directly to these critics?” Woodcock’s reply: “I think we will have some more public soul-searching type of discussions on accelerated approval itself, but the soul-searching when a decision is made goes on before the decision, and once we’ve made the decision, we’ve made the decision.”

Similarly, the head of the Alzheimer’s Association wants to enddiscussion of the approval:

Harry Johns is ready to stop talking about whether or not the Food and Drug Administration should have approved Aduhelm, the divisive new Alzheimer’s treatment that got the green light last week. “Dwelling on the approval at this point is not productive for those who can benefit from the treatment,” said Johns, the CEO of the Alzheimer’s Association. The “negative voices” focused on criticizing the decision, he said, are “not pro-patient.”

But, if the aducanamab approval is not rescinded, what will happen and what are the consequences? More on that in another post.

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  1. Maritimer

    Aducanumab. That sure is a mouthful of letters and vowels. Seems to violate numerous marketing naming rules. “Doctor, I was wondering about adyconomuble.” Gonna cost a bundle to drill that into the human consciousness.

    So, there’s hope. In this case, it would seem the Aaduxyzmnopbeebopalula committee was taking some of their own mind altering pharma products or maybe ayahuasca which oddly enough has the same number of vowels as aducanumab. Ommmmmmmmm….

    1. PlutoniumKun

      It reminds me of the old joke about whoever invented the spelling of the word ‘dyslexia’ being a sadist.

      1. Brooklin Bridge

        [s] Google translate comes up with, “Grab the money and run like hell!” [/s]

    2. Mark

      The names, brand and generic, actually do follow the standard convention for such things. The generic name (in this case aducanumab), is purposefully difficult and unpronounceable. This is the name that competitors would have to use after a patent expires (not actually applicable in this case since it’s a monoclonal antibody but that’s a different, much longer story). Biogen will now attempt to make the brand name, Aduhelm, the name that Docs, patients, etc will use and remember. It is purposefully intended to be simpler and easier pronounce than the generic name.

    3. Keith Howard

      Sometimes simply capitalizing one letter will clarify at least a possible pronunciation, as: AducaNumab, which would chime with Be-bop-a-Re-bop.

    4. Mel

      It’s a sign that there are more patented drugs now than there are reasonable names. That’s a lot of patented drugs.

  2. cocomaan

    For years, libertarian types have said that the FDA needs to deregulate, that they are getting in the way of advancement in Pharma research, etc.

    What’s funny is that the Congress has created a set of emergency regs that let the FDA push through mRNA vaccines via terrorism laws, while they are seeming to approve Abacadabra or whatever the hell this drug is called (as Maritimer points out) in the more libertarian mindset of “who cares.”

    FDA, bipartisanship at its finest!

  3. Katniss Everdeen

    If it wasn’t clear before, it should be crystal clear after this–you simply cannot trust the fda on anything.

    I’d go so far as to say you also shouldn’t trust doctors who hide behind fda “approval” to prescribe medications knowing full well that “approvals” can be blatantly bought.

    Since “healthcare” in this country relies so heavily on fda “approved” pharmaceuticals and devices to determine standard of care, this mindless, nakedly mercenary decision is an indictment of the entire sorry system, and as clear an explanation as there ever was of the abysmal results that system consistently “achieves. ”

    I will be curious to find out what the European medical establishment decides with regard to this medication. They are, or at least have been in the past, willing to demand that drugs exhibit at least some level of efficacy before they are willing to pay for them, particularly when the prices are exorbitant.

  4. jackman

    A Tale of Two Molecules of Disputed Efficacy, Aducanumab and Ivermectin.

    On the one hand is Aducanumab, costing $56,000 a year to Medicare, and requiring an additional regimen of MRI’s to monitor against brain injury side effects. On the other is Ivermectin, essentially costing nothing, with 40 years of remarkably safe usage. In both cases, they’re stepping in for dreaded diseases, Alzheimers v. Covid, although the latter is contagious and killed millions, with unknown potential to decimate the species if left running wild. One will make many people very rich, while the other will make no money for anyone–although it might make people healthy. One is openly promoted and approved by the government and private interests, while the other is forbidden to mention on the internet.
    Sorry, sorry world.

    1. IM Doc

      I agree.

      This is exactly why the reputation of public health and medicine are in tatters. The longer this is allowed to happen, the less likely the current system will ever be able to recover. I am not sure when the Rubicon is crossed – but it has to be very close.

      1. KLG

        A comment from this morning lost in the ether:

        Yes, the names are strange. Imatinib is a protein kinase inhibitor known as Gleevec. It works well but did not turn out to be the universal game changer of the original celebration of the Masters of Molecular Biology at Ciba-Geigy (now Novartis after a merger with Sandoz). Yes, this was a magnificent accomplishment by Nicholas Lydon and his team, but what they mostly did was add a room to the penthouse of a high rise building built by NIH, MRC, CNRS, and other equivalents around the world. Which is how it should be. Aducanumab is a monoclonal antibody that does something, but whether that something deals with an Alzheimer’s cause, correlation, or effect is unknown. Except for the bottom line of Biogen, this will not end well. But what the hell ever does these days? Why does this remind me of the transnational institutional response to COVID-19?

  5. PHLDenizen

    Anyone who deploys the term “soul-searching”, particularly in life sciences, immediately relinquishes any credibility, ability to be taken seriously, and suffers from stupidity, disingenuousness, or both. “Soul-searching” is one of the dumbest, most unimaginative, most grating moribund metaphors I’ve ever encountered. It signals “I have no capacity or interest to figure things out in any useful way, but people will sympathize with just ‘how hard and complex’ the struggle is for me in my role. I emerge unscathed by criticism.”

    Souls don’t exist, except in the mind of people like St. Augustine, who considers souls the essential, “true” core of what constitutes humanity. It’s a line of demarcation between the material and immaterial. For argument’s sake, even if the soul DOES exist, in no way should anyone be searching it for scientific data and let it whisper answers to you. You can’t even prove souls exist!

    Woodcock sounds more like a Christian Science practitioner through deliberate ignorance of what the data says. Worse still, she behaves like a deity: I’ve made my judgment and, as a lesser god, it is final and eternal. My guess is thalidomide and Baycol would never been pulled on her watch.

    Medicine is more art than science in many cases, but no med school students take classes in “Biblical remedies”. If the FDA approved prayer as the first line treatment for cancer, would people give up chemo, etc.? No. And the approval of this drug has its genesis in almost religious belief.

    “Pro-patient” would be giving families a yearly stipend equal to the cost of this ineffectual pile of sh!t, incentivizing and enabling families to take care of their ailing Alzheimer’s relatives at home. Quality of life is, in large part, measured by how much time you’re allowed to spend with those who love you. This drug is garbage, it gives families an excuse to minimize the effort and assuage guilt expended on humane end-of-life care, and does nothing to arrest the trajectory of being locked away in some “memory ward”. My hunch is Alzheimer’s units actually make the decline worse. And it reinforces the notion of disposability with regards to the elderly. I’ve always found that appalling.

    I think both Woodcock and Biden meant “sole”. As in we’ve got fancy new football cleats and we’re busy using these soles to step on everyone less fortunate. Die faster and more miserably, right?

  6. Carolinian

    There was a time–lost in the mists of history–when the media and programs like Sixty Minutes might be expected to go after corporate scams such as this. Perhaps it’s just a coincidence that every other ad on our current news shows are for some drug. Everyone, it seems, has been bought.

    Step one for limiting pharma corruption: ban advertising. Most countries do I think.

  7. Margret Brady

    After noticing how my husband’s Alzheimers was increasing and the across the board treatment he was receiving, I saw how intently he seemed to watch the ads for alzheimers medications and that they all claimed that he would get progressively worse, I tried an experiment. Every time an ad was on TV, I commented that there was no proof that they were accurate. I began to speak to him and treat him as though he could understand everything I told him and began expecting him to do more and more for himself as he improved. He began to write me notes again after thinking he was unable to write. He began to take an interest in what was going on and we began going out to our favorite pubs and coffee shops again. When he died of other causes several years later, he had returned to his mentally alert ways and his sense of humor had returned. I was so grateful to have my partner back and he was so grateful for my efforts and our love was stronger than it had ever been. We both realized that being disoriented after surgery had led to his confusion and having medical “professionals” jump to the wrong conclusions which we both believed. How many other false messages are we all receiving?

  8. allan

    Unless reversed, the FDA decision might lead to similar outcomes for drugs for other diseases:

    Controversial Alzheimer’s drug approval could affect other diseases [Nature]

    … Some advocacy groups are also encouraged, on behalf of desperate patients with few or no therapeutic options. “If the FDA can find a way to be flexible for Alzheimer’s, maybe they can find a way to be flexible for ALS,” says Neil Thakur, chief mission officer at the ALS Association.

    But many researchers fear that this regulatory precedent puts false hope above solid clinical science, and harms patients in the process. “Folks who are considering this approach should take a deep breath and a cold shower,” says Fyodor Urnov, scientific director of the Innovative Genomics Institute at the University of California, Berkeley, and a former drug hunter at Sangamo Therapeutics in Brisbane, California.

    “I don’t want a future where we have multiple prescribable medicines. I want a future where we have multiple prescribable medicines that work.” …

    Patrizia Cavazzoni, a high-ranking FDA official, has given a nod to aducanumab’s broader impact. “The accelerated approval pathway has been an incredibly useful tool in oncology,” she said in a press meeting. “We believe it serves as a model that we hope can be replicated with neurodegenerative diseases.” …

    … some of which will make $56,000 / year look like chump change.

  9. Another Scott

    One note about Warren, Biogen is headquartered in Massachusetts and is seen as one of the marquee names in the state’s biotech sector. I haven’t looked it up, but I would imagine that the company and it’s employees are large donors to her campaigns.

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