Friday, June 11, 2021

Personal Blog #23 ... Letter to Acting FDA Commissioner re Aduhelm ... 6/11/21

 

On 6/7/21, the FDA approved the drug Aduhelm, Biogen’s aducanumab medication, an intravenous infusion to be administered monthly for people with Alzheimer’s disease.  Despite not one member of the FDA’s Advisory panel voting to approve this med, FDA approved its use anyway.  FDA determined that since Aduhelm helped clear some amyloid protein from the brain, it may be “expected to help slow dementia.”  However, Biogen’s own data do not support such a claim, and readers can read my Personal Blogs #11 and #12 to learn more about results of clinical trials with this drug. 

Aduhelm will also be a very costly drug.  It is priced at $56,000 a year.   As noted in Newsday on 6/10/21 (Lane Filler, page A25), “If 10% of American Alzheimer’s sufferers began using aducanumab, the tab would be $33.6 billion annually billed to Medicare for the still-solvent sufferers and Medicaid for those bankrupted by the disease.”  That is money that could be better spent elsewhere. 

Earlier today I sent the following letter via email to Janet Woodcock, acting FDA Commissioner, at Janet.Woodcock@fda.hhs.gov  re FDA approval of AD med, Aduhelm:

As a former Alzheimer's disease (AD) caregiver ... my wife died after her AD struggle in 2016 ... I want to register my strong objections to the FDA's decision to approve yet another "bottle of hope" for people with AD.  Having been a member of an AD spouse support group for many years, having briefly facilitated spouse support groups for the Alzheimer's Association, and having had more than 100  articles published about AD (www.allansvann.blogspot.com), I can attest to the serious negative consequences approval of Aduhelm will have for many surviving spouses.  

In 2013 I wrote about FDA-approved AD meds in one of my articles.  Quoting from that article, "Despite there being no research to support the effectiveness of these AD medications beyond a few months, at best, many doctors continue prescribing these medications for years and years. Not only can these AD medications no longer be helping their patients, but they may actually be causing some harm. Maintaining patients on these medications long term may provide false hope to patients and their caregivers. I refer to these medications as “bottles of hope” because as I watch my wife decline, I know that the medications cannot possibly be helping anymore, if they ever did at all.  For many patients and caregivers, the high costs of AD medications present an economic hardship. Money spent on AD medications is money that might otherwise be spent on day care programs, companions, home health aides, or other services that would actually improve the quality of their lives."

I witnessed AD spouse caregivers having to spend life savings on AD meds.  Some had to sell their homes when placing spouses in assisted living or to cover costs of home health care aides.  Now even more will have to do so because of money needlessly spent on this latest bottle of hope you have approved.  Based upon data I have seen ... a difference of 0.39 on an 18 point scale of cognitive and functional ability ... I can understand why not one member of your 11 member Advisory panel of experts that evaluated the data for FDA voted for approval.

I am SO sorry that FDA has approved yet another costly "bottle of hope" that will now financially ruin the lives of more AD spouse survivors with virtually zero benefit to their loved ones.  This is just not fair to people with AD, and not fair to their eventually surviving spouses.

After writing this email to Dr. Woodcock at FDA this morning, we entered into a series of email exchanges during the day.  Here is what we wrote to each other, beginning with her response to my email:

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I’m very sorry to hear of your loss.  Thank you for writing. This new drug, unlike the previous ones, is intended to slow the course of the disease rather than simply help with symptoms.  Janet Woodcock

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Thank you for your prompt reply, but good intentions do not help loved ones nor do they help pay for aides and other needs of loved ones. If you were a member of a spouse support group ... and I hope you NEVER have that experience ... you would understand the severe negative consequences these meds have on loved ones with AD and their spouses. With all due respect, I think this is not just the wrong decision, but worse another decision that will make life an even greater hardship for those who survive. In fact, I just posted a column opposing this decision on my site.

I hope you reconsider your decision asap.

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I am sorry you feel this way.  I have had a close family member die of Alzheimer’s disease and am well aware of the trauma to all involved.  Slowing the rate of cognitive decline is an important goal.  Janet Woodcock

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I agree 100% that slowing the rate of cognitive decline is a very important goal. My gripe is that there is no clear evidence that this med will actually slow cognitive decline in a meaningful way. Unless and until Biogen can produce clear evidence that their medication does slow cognitive decline to a significant extent, it remains only an expensive bottle of hope. The costs to Medicare and the thousands of dollars patients will be facing with deductibles will cause much more harm than good.

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I won’t continue writing to you on this topic because it seems we will just have to agree to disagree.  However, I just read that a 3rd member of your 11 member Advisory Panel has now resigned as a result of this FDA approval.  To quote from CNBC …Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, said the agency’s decision on Biogen “was probably the worst drug approval decision in recent U.S. history,” according to his resignation letter obtained by CNBC.“  

At the last minute, the agency switched its review to the Accelerated Approval pathway based on the debatable premise that the drug’s effect on brain amyloid was likely to help patients with Alzheimer’s disease,” he wrote in resigning from the FDA’s Peripheral and Central Nervous System Advisory Committee.

He wrote it was “clear” to him that the agency is not “presently capable of adequately integrating the Committee’s scientific recommendations into its approval decisions.”  “This will undermine the care of these patients, public trust in the FDA, the pursuit of useful therapeutic innovation, and the affordability of the health care system,” he said.  

Dr. Woodcock … I thank you for allowing me, a former AD spouse caregiver, to have access to you in sharing my feelings and concerns.  We both want the same thing, Dr. Woodcock. Now 74, I will remain an AD patient and caregiver advocate for life.  I continue writing for publication and posting personal blogs to help further AD awareness, to try to bring about change in the medical profession, and to help other caregivers.  I want so much to see a new medication that will truly slow down the progression of the disease to allow a longer period of quality of life.  I want so much to see development of a new medication that will successfully treat if not cure AD.  But this new medication is just not the one that FDA should be lowering their standards for, not the one to create false hope among those suffering with AD and not the one to create such financial stress for caregivers.  When an Advisory FDA panel has 11 experts and not even one of those experts votes to approve this medication, one has to wonder how something like this could happen.  But, again, thank you for allowing me to express my concerns.


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