* A reflection on STAT article: Joseph, A. (June 16, 2021). Q&A: The CEO of the Alzheimer’s Association on the approval of Aduhelm – and why critics should stop dwelling on the decision. Link: https://www.statnews.com/2021/06/16/qa-ceo-alzheimers-association-on-aduhelm/
A lot has been said and written in recent weeks about the FDA controversial approval of the drug Aduhelm and the role Biogen and certain FDA officials played in it. Relatively little attention has been dedicated to the key role of the National Alzheimer’s Association (AA) in the decision and its aftermath.
On May 6, 2021, the AA launched a campaign called “More Time” to support the FDA approval of the drug. The full-page advertisements in the Wall Street Journal (WSJ) and USA Today were an open letter from Harry Johns, CEO of AA. In addition, AA purchased full digital takeovers of the WSJ and USA Today online properties. It also launched campaigns on Twitter, Facebook, Instagram, and Linkedin. In his letter, Johns suggested that if the drug would not be approved by the FDA, it would “deny those who face Alzheimer’s and their loved ones” the opportunity “to have more precious time together.” He said that it would be considered “inhumane” if the FDA will not approve the drug. As we know, AA’s campaign realized its goal when the FDA approved the drug on June 7, 2021 (Belluck, P. & Robbins, 2021).
In effect, Johns’ statement constituted a promise that the drug Aduhelm will modify the course of Alzheimer’s disease. Promise is defined as, “a legally binding declaration that gives the person to whom it is made a right to expect or to claim the performance or forbearance of a specified act” (Merriam-Webster Dictionary).
The AA prominently declares on its website, “It’s a New Day in the Fight Against Alzheimer’s – Aducanumab Approved.” The announcement states, “This approval is a milestone in the treatment of the disease and a beginning of a completely new future for Alzheimer’s treatments.” It adds that AA, “welcomes and celebrates the historic FDA approval of aducanumab” and that “this approval is a victory for people living with Alzheimer’s and their families.” In this article, I will take a closer look at some of the statements made by Johns and AA in hopes to shed more light on their validity with the goal of better informing the public.
Johns’s promise should not come as a surprise. The National AA has a long history of knowingly making unfounded promises for cure and effective treatments of Alzheimer’s disease. A couple of years ago, I published an extensive journal article reviewing this history (Caspi, 2019). Beyond making these promises on a regular basis (without being held accountable when these promises don’t realize themselves), AA often uses images reflecting a “tragedy discourse” (Reed and colleagues, 2019) as an integral part of these well-funded and large-scale campaigns. This is a problem for various reasons among them is that it perpetuates, rather than reduces, the stigma associated in our society with Alzheimer’s disease (Joyce, 2018; Lomangino, 2018). One should expect influential organizations such as AA to be mindful of this stigmatizing effect and do everything within its power to avoid such stigmatization. The late Richard Taylor, author of the book Alzheimer’s From the Inside Out, who lived with Alzheimer’s disease educated us though his lived experience and inspiring advocacy that it is possible to have a cognitive disability but still live outside the stigma (Taylor, 2011; Power, 2015).
The AA, also referred to by some professionals in our field as the “800-pound Gorilla” (Joseph, 2020), has a tendency ” to wield its power when individuals, professionals, researchers, and even leading dementia-specific advocacy organizations don’t meet its expectations or when people and organizations release or intend to publically release accurate information in an effort to balance AA’s unbalanced, misleading, and unethical claims such as those that could be characterized as “false hope narrative” (Caspi, 2018).
As reported by STAT, AA has also used bullying tactics when in recent years a significant number of local AA chapters decided to break away from it. Some of these chapters described AA’s behavior towards them as “vindictive” and “very aggressive.” They reported that they left the National AA due to its misplaced priorities, among others, those surrounding the decades-long “care vs. cure” tension (Graham, 2016). In the STAT article, Bill Keane, who served on the board of AA during the 1990’s, shared, “there was always a lot of friction” over whether to focus on caring for current people with dementia or pouring resources into a future cure. He added that services for families “typically got the short end of the stick” compared to research.
Going back to Johns’s promise to millions of people living with cognitive impairment in the U.S. and other countries. Notably, Biogen’s spokesperson stated, “It would be inaccurate to speak to an effect on disease progression or related cost savings with Aduhelm. It’s important to clarify that the clinical benefit of treatment with Aduhelm will need to be verified in our Phase 4 clinical trial” (Rosenbaum, 2021). Johns and AA, however, have no problem saying that things like Aduhelm “delays decline” or “slow progression.” One is left to wonder whether AA knows and understands currently existing data pertaining to Aduhelm better than it’s maker Biogen. Or are we missing something here?
Ten days after the FDA approval of the drug, Johns said, “We believe the FDA did the right thing…” He added, “Dwelling on the approval at this point is not productive for those who can benefit from the treatment.” Later in the interview, he said, “We want people to understand that it can make a difference for them, but we don’t want them to think it is going to absolutely change their course.”
There are at least two problems with this statement. The first is that the need to continue and laser focus on the FDA approval of the drug is obviously of critical importance, as multiple reports by the NY Times, STAT, among other major media organizations have shown in this rapidly evolving story in recent weeks (Belluck, Kaplan, & Robbins, 2021; Molchan, 2021; Thambisetty, 2021). Dwelling on the decision is exactly what is needed if our society still cares about truth, ethics, biomedical science, and evidence-based public health (these four constructs are highly interdependent or at least they should be). Heavy daily focus on the FDA decision is warranted because it touches at the core value of trust, which is defined as “assured reliance on the character, ability, strength, or truth of someone or something” (Merriam-Webster dictionary). Without public’s trust in AA’s character and its moral campus, the association with all its might will remain limited in its ability to effectively serve a greater proportion of the population of people living with dementia. For example, some people may not know that “as many as half of [the] people satisfying diagnostic criteria for dementia have never received a diagnosis” (Lock, 2013) and that for years the AA has been struggling to identify these people and provide them and their family care partners with timely educational and support services.
In addition, the New York Times reported recently that AA struggles to recruit people with dementia to clinical trials designed to evaluate the effectiveness and safety of drugs aimed at treating the disease and finding a cure (Kolata, 2018). I wish that AA would finally recognize that one of the reasons for this major challenge has to do with the steadily eroding trust the public places in it.
It is time to say it plane and simple: If you establish your organization’s reputation as one that regularly makes disingenuous and untruthful public statements about treatments for Alzheimer’s disease, eventually a critical mass of people will stop trusting you and believe in what you have to say. I tried to encourage AA to consider it in my aforementioned journal article Trust at Stake but AA’s “vigorous support” of the FDA’s approval of the drug Aduhelm suggests that my effort fell on deaf ears.
The second problem with Johns’s statement is that the available empirical evidence in support of clinical benefit of the drug Aduhelm is weak (not to mention the common and adverse side effects identified in the drug’s clinical trials such as brain swelling and bleeding); thus, to suggest that there’s a real world “benefit form the treatment” of Aduhelm is questionable.
Johns added that the “negative voices” focused on criticizing the FDA decision are “not pro-patient.” There are three problems with this statement. First, beyond overwhelming experts’ opinion (American Geriatrics Society, 2021; AMDA, 2021; Silverman, 2021) and FDA own advisory committee that overwhelmingly voted against the approval of the drug (Joseph, 2021), the extent to which we know the opinions of people living in early stages of dementia about the FDA approval of the drug is unclear. To address this gap, Lori La Bey, founder, Alzheimer’s Speaks, and I co-facilitated a Dementia Chats video session with several individuals who are living with cognitive impairment (Alzheimer’s Speaks, 2021). During the conversation, Dr. Jennifer Bute, who used to diagnose dementia in England before she herself was diagnosed with Alzheimer’s disease, said:
“One of my great concerns is this business of trust. I feel that there has been false reporting as well as incomplete reporting and people who desperately want hope will have had this unfair false hope brought to them and when eventually it must be realized it isn’t there, will that dent their trust in other medication, other treatment, the medical profession, and research? So that really does concern me.”
Bute is the author of the 2018 book Dementia from the inside: A doctor’s personal journey of hope.
Paulan Gordon, who is an educator and advocate living with vascular dementia, said,
“I am skeptical about the drug…I hate to see people manipulated…people who are suffering and really want help and that upsets me probably more than anything about the whole thing. I don’t have a lot of confidence in the drug…” She added, “I just hate to see it play on people’s heart strings…people who are desperate for a cure following something that could be very risky.”
Paulan is the author of the 2017 book Vascular dementia: An inside perspective by Paulan Gordon.
Second, the AA does not have full ownership of what initiatives, programs, services, and drug treatments constitutes “pro-person living with dementia.” Other organizations and advocates care about this underserved population at least as much as AA does. And by the way, it is time that AA will recognize that many people living with dementia (unless being in or living in a medical setting) prefer to be called people living with dementia, not “patients” (Dementia Action Alliance, 2015).
The STAT article by Andrew Joseph reported that Johns is “jubilant” about the new drug option for people living with Alzheimer’s disease. His comment was made in the early days after the FDA approval of the drug so maybe by now, with the extensive media coverage and evidence showing how unprofessional and unethical the FDA decision was, he may have second thoughts. Sadly, judging by his and AA’s long track record of being untruthful with the public with regards to unfounded promised for cure of Alzheimer’s disease, I am inclined to think that he will not change his mind.
Reporter Andrew Joseph asked Johns: “How and why did you decide to endorse the therapy?”
Johns: “We came to the conclusion that the science was sound for what is a very large population of people who have not had treatment.” On a separate occasion, Dr. Maria Carrillo, chief scientific officer of AA, stated about the drug’s clinical trials, “The science is sound.” Johns added, “Now, clearly, this is not a cure, and it is a marginal difference for people, but a marginal difference can make a real difference for people who have only the devastation of Alzheimer’s to look to. So looking at all the science, looking at all the impact, we chose to strongly endorse approval.”
Later on, Johns went on to describe the “crushing realities” of people who face the disease as a reason why the FDA should have approved the drug. His statement reflects the predominant “tragedy discourse” (Reed, 2017) of Alzheimer’s disease our society came to see as the norm, one that we need to see in a more balanced way. The real devastation caused by Alzheimer’s disease on people living with it and their family members can be reduced when these individuals are enabled to live outside the stigma (Taylor, 2011) and when they are adequately supported throughout the disease. To say, “…people who have only the devastation of Alzheimer’s to look to” perpetuates the stigma of living with the disease, which limits, rather than opens, important opportunities to support these individuals, assist them in having purpose and meaning in their lives, engage them in personally meaningful activities, enhance their emotional well-being, and enable them to live their lives to the fullest despite having a serious cognitive disability. In addition, experts believe that it may be possible to delay Alzheimer’s disease onset and progression when a society commits to a nationwide public health prevention approach that is based on known lifelong risk factors and healthy lifestyle (Lock, 2013).
A couple of years ago, Dr. Paul Raia, developer of Habilitation Therapy, who worked as Vice President of Clinical Services at AA’s Massachusetts chapter (he worked at AA for nearly 30 years), wrote,
“Too much attention is given to the quest for the ‘magic pill,’ too little attention is being given to prevention through healthy lifestyle, too little money and research is put into treating symptoms of those living with dementia with behavioral interventions, too little money is put into supporting families as caregivers, and too little effort is put into regulating services like adult day heath [centers], assisted living and dementia care in nursing homes. In all of this, the Alzheimer’s Association has focused on the wrong targets and exploited the general public lack of information.”
Directly related to it, it is time that our society will engage in deep reflection about what makes it so that “older Black and Hispanic Americans are disproportionally more likely than older White Americans to have Alzheimer’s or other dementias” (Alzheimer’s Association, 2021). If not during these horrific COVID-19 pandemic times when gross racial injustices and health inequalities were made abundantly clear in our society, then when?
In the STAT interview, Johns went on to say, “It is the first treatment that targets the underlying disease, rather than just symptoms.” This statement was also displayed on the homepage of the AA on July 22, 2021. It is problematic and potentially misleading because there is overwhelming evidence suggesting that amyloids are questionable when it comes to the cause of Alzheimer’s disease (Lock, 2013). One scientist quoted in Lock’s book Alzheimer’s Conundrum said, “amyloid deposition is clearly like the outcome of a car crash, but the investigator ends up looking at the debris instead of what happened to bring about the crash.” Lock stated that this scientist “then likened this to clearing up a car crash and assuming that will prevent future injuries.”
A series of facts need to be taken into consideration when interpreting Johns’s statement. First, “a very large number of people with plaques in their brain never become demented” (Lock, 2013). Second, a substantial portion of people with mild cognitive impairment (MCI) and a significant subgroup of people with presumptive diagnosis of Alzheimer’s disease don’t have elevated beta amyloid levels in their brains (Thompson, 2021). Third, only a subgroup of people with mild cognitive impairment ends up developing Alzheimer’s disease. Specifically, the Mayo Clinic states, “Mild cognitive impairment may increase your risk of later developing dementia caused by Alzheimer’s disease or other neurological conditions. But some people with mild cognitive impairment never get worse, and a few eventually get better” (Mayo Clinic, 2021). Fourth, many very old people have amyloids in their brains but don’t have Alzheimer’s disease (Brody, 2021). Fifth, there’s mixed dementia. This condition occurs “when the individual shows the brain changes of more than one cause of dementia” (Alzheimer’s Association, 2021). In Alzheimer’s Facts & Figures 2021 report, AA stated, “studies suggest that mixed dementia is more common than previously recognized, with more than 50% of people with dementia who were studied…having pathologic evidence of more than one cause of dementia.” Sixth, in discussions regarding treatment for Alzheimer’s disease we need to take into account the fact that some experts believe that Alzheimer’s disease may actually be a syndrome (Devi, 2017). Specifically, in her book The Spectrum of Hope, Dr. Gayatri Devi who is a neurologist specializing in dementia and memory loss for over 20 years, stated, “Alzheimer’s is not a single disease entity, but rather a spectrum disorder that presents with different symptoms, progresses differently, and responds differently to treatment with different prognoses, for each person.” Seventh, there are many other forms of dementia such as cerebrovascular disease, lewy body disease, fronto-temporal lobar degeneration (Alzheimer’s Association, 2021) and misdiagnosis of Alzheimer’s disease is common in general but especially among older African Americans and Hispanics (Gianattasio and colleagues, 2019). Eight, many experts believe that solely addressing amyloids may not bring about the desired clinical effects on people living with Alzheimer’s disease. For example, Dr. Aaron Kesselheim from Harvard Medical School wrote in his resignation letter from the FDA Advisory Committee that one of the reasons he voted against the FDA approval of the drug Aduhelm was the “debatable premise that the drug’s effect on brain amyloid was likely to help patients with Alzheimer’s disease.”
Even Johns himself stated shortly before the COVID-19 pandemic, “I don’t think that there’s anyone out there today who thinks [amyloid] is exclusively the answer” The STAT article went on to say, “which is partially why the Alzheimer’s Association has diversified the types of research it funds in recent years” (Joseph, 2020).
Despite these well-known facts, thought leaders such as Dr. Rudy Tanzi seem to have had no problem hyping the amyloid hypothesis shortly after the FDA approval of the drug Aduhelm (Tanzi & Shriver, 2021).
Taken together, one has to wonder what makes it so that these and other well-known weaknesses inherent in the amyloid hypothesis do not receive sufficient attention when examining the process leading up to the FDA approval of the drug Aduhelm and the key role AA played in the decision and its post-decision public relations and promotion efforts.
One important but often overlooked reason for the staying power of the amyloid hypothesis despite its glaring weaknesses was reported on extensively in a STAT article by Sharon Beglev a couple of years ago (Beglev, 2019). In it, Belgev identified evidence for an Alzheimer’s “cabal” – a small group of powerful researchers who for decades have dominated the field and in various ways made sure that the amyloid hypothesis will take center stage. This was done through setting priorities for research funding that favored proposals that were based on the amyloid hypothesis, influence on acceptance and rejection of research manuscripts by prestigious journal publications, and rejection of non amyloid-based papers submitted for presentation in impactful conference. By doing so, these efforts limited other as promising if not more promising areas of research aimed at identifying the causes of Alzheimer’s disease and different strategies for treating their underlying mechanisms.
Later in the interview, Andrew Joseph asked: “Should other therapies that have shown a reduction in amyloid be approved then even if they haven’t demonstrated a clinical benefit?
Johns: “Well, we believe this treatment has demonstrated benefit.”
At this stage of science, the suggestion that the reduction of brain amyloids necessarily means that it results in clinical benefit in people’s lives is questionable.
Andrew Joseph: “So if Aduhelm fails its confirmatory trial, should it be taken off the market?”
Johns: “If the drug does not demonstrate effectiveness, then we certainly don’t want our constituency to be trying to pursue treatment that isn’t successful.”
Once again, the vast majority of experts agree that the clinical trials conducted thus far on the drug Aduhelm didn’t show sufficient clinical effectiveness. But there’s another potential problem here. Certain medications receiving conditional FDA approval end up staying on the market even after subsequent clinical trials do not demonstrate the desired clinical effects. So in reality, it is not impossible that this will also end up being the case with the drug Aduhelm. Making things worse is the fact that the FDA has given Biogen no less than nine years to complete these additional trials; a very long period during which the public (tax-payers) will shoulder the lion share of the massive bill (Katz and colleagues, 2021).
Johns went on to say, “…we haven’t had a drug in 18 years and certainly we’ve never had one that improves the potential path of the underlying disease.”
Wait a second…did Johns actually say “…that improves the potential path of the underlying disease”? Okay, let’s unpack this one a bit. First, the drug did not show improvement in the underlying disease in general and because it is not clear whether amyloids are the definitive cause of Alzheimer’s disease. Second, with regards to the words “…the potential path…”, does this mean that Johns is not sure that it is the actual path of the underlying disease but rather merely a potential path.
I thought that the FDA job is to approve drugs that improve the actual path of Alzheimer’s disease, not potential paths? There are many unproven drugs that could target the potential path of countless diseases. It is my understanding that the FDA’s main job is to determine which ones have solid empirical evidence – in terms of real positive impact in people’s lives – and which ones don’t. If the FDA will frequently approve every drug that “improves the potential path” of hundreds of diseases, the harm caused to people (not to mention the cost) would be such that there may not be enough people left in America to take the medications that actually work and are safe. If not reversed by Congress, this FDA approval of the drug Aduhelm could set a dangerous norm that may result in a large-scale violation of the Hippocratic Oath, “First, do no harm.” With similar amyloid-targeting drugs in the pipeline, the cement on this FDA decision – that is, the new norm – may settle quite fast.
Later on Johns said about AA, “We’re here to drive science and set what is the path to facilitating approval…” Johns also describes AA “as a science-driven organization.”
Well, most people with eyes in their heads (no need to have a PhD in neuroscience or biomedical science) can see that in this case AA has done nearly everything except “drive science.” Maybe Johns meant to say that AA is determined to drive science into the ground and along with it the public’s already fragile trust in biomedical science, pharmaceutical companies (Angell, 2004), and the AA.
Johns added, “We have no specific interest in this company or treatment.” Well, last year, Biogen gave AA no less than $275,000 beyond additional $2,839,302 from 25 other pharmaceutical companies (Alzheimer’s Association, 2021). No specific interest? Biogen, being the fourth biggest pharma donor to AA, strikes me as fairly specific. At the very least, it warrants taking a closer look at Biogen-AA relationship and whether it influenced AA’s role and support in the FDA approval of the drug.
Johns’s message and unfounded narrative regarding the promise that Aduhelm will make a real difference in the lives of millions of people living with cognitive impairment has been communicated across the country through AA’s local chapters. For example, Christy Kovel, director of public policy, Alzheimer’s Association Connecticut Chapter, spoke about the FDA approval of the drug. The following is an excerpt from the interview she gave on CT Public Radio on June 29, 2021 (Baskauf & Nalpathanchil, 2021).
Reporter Lucy Nalpathanchil: There’s an advocacy group, one of the lead ones in our country, that supports this choice for families. So tell us why the Alzheimer’s Association welcomes the FDA’s approval of Aducanumab?
Christy: “I think recognizing the controversy, there is a dire and drastic need to offer relief and support to the millions of Americans impacted each day you know by the crashing realities of Alzheimer’s disease. We recognize this is the first you know in many many years of a drug showing some hope but we know that this will open up and invigorate the field of research, increase investment in new treatments, and generate greater innovation.”
Lucy: How do you respond to the concerns though where doctors and others say look, the science is just not there to show that this medicine is effective and actually modifies the course of the disease?
Christy: “The Alzheimer’s Association works with many scientists in the field and we respect, welcome and encourage different perspectives. Differences in opinion and interpretation among scientists are normal and important…you know, with varying perspectives, they are essential to drive the field forward.”
There are a few problems with these responses. First, false hope is different from “some hope.” Second, I already addressed the problem inherent in deterministic terms such as “crushing realities” that reflect a fear-driven, stigmatizing, and unbalanced “tragedy discourse.” Two of my grandmothers lived with dementia and I’ve worked with and consulted hundreds of family members of people living with dementia over the years. I know very well that the disease can be crushing but I also know that this is not and should not be the only story we can tell about this disease and the people who live with it. The AA knows this but for some reason it insists for many years that without a miracle drug and magic bullet, people “have only the devastation of Alzheimer’s to look to,” in Johns’s words. The time to change this narrative is long overdue.
Dr. Paul Raia shared his thoughts about the role of AA in the FDA approval of the drug, his interpretation of it, and his call to AA. On July 19, 2021, he wrote me,
“Biogen and the National Alzheimer’s Association entered into a morally questionable symbiotic relationship recently. This stemmed from the FDA’s controversial approval of Biogen’s drug, Aduhelm, with only scant supportive data showing the drug’s efficacy in the treatment of Alzheimer’s disease. Biogen desperately needed public support and a potential customer base to counter the negative publicity surrounding the drug’s approval. They found it in the Alzheimer’s Association’s multimedia heralding of this new drug, with no mention of its limited potential benefits for only early-stage patients and its high cost.
Like any symbiotic relationship in nature, both organizations must derive mutual benefit in order to survive. In this case, Biogen gets credibility from a trusted patient advocacy organization and access to its national network of early-stage patients, i.e., customers. The national Alzheimer’s Association is seen by its constituency as actively advocating for a cure, and it is the recipient of Biogen’s cash donations with lots of zeros.
In this relationship the National Alzheimer’s Association is bound to damage its credibility with the public and the professional community. As a former employee of this important organization that has helped millions of patients and their families over the years, I urge the Association to pull out before it is too late.”
Three days later, with the eye into the future, Raia raised key questions that I believe we should all give some good thought to. They include:
Will the Association promote the drug within each chapter’s early stage groups?
Will Biogen be at their conferences recruiting customers?
Will Biogen be making contributions greater than their previous contributions?
Will the Association walk back their initial over the top endorsement of the drug?
Will Alzheimer’s Association staff publicly/privately endorse the drug within their contacts with physicians?
And most obviously, will the association attempt to solicit donations from the public for their role in supporting the drug’s approval?
Looking back from the vantage point of the year 2030 (the FDA gave Biogen nine years to complete its conditional clinical trials of the drug Aduhelm), will the story of Aduhelm end up being one that strengthened or weakened the public’s trust in the National Alzheimer’s Association, biomedical science, the FDA, the pharmaceutical industry, and our lawmakers?
Will other large healthcare systems join Cleveland Clinic and Mount Sinai in their decision to avoid administering the drug Aduhelm (Belluck, 2021) until solid empirical evidence in support of its clinical benefit and safety will be demonstrated and accepted by the scientific community?
Congress is planning to investigate the process that led to the FDA approval of the drug (Florko, 2021; U.S. House Committee on Oversight and Reform, 2021) while the FDA requested the Office of Inspector General to investigate its own process resulting in the approval (Garde and colleagues, 2021).
My hope is that these investigations and those conducted by leading media organizations such as STAT and the New York Times will continue to play a key role in uncovering the truth about what had transpired in the triangle Biogen-FDA-Alzheimer’s Association in the years, months, weeks, and days prior to the approval of the drug and its aftermath.
Uncovering the truth is also crucial to strengthening our society’s precious but thus far largely untapped asset of “authentic partnership” (Dupius and colleagues, 2011) with people living with Alzheimer’s disease and their family members. It is only when truth is seen as the foundation of science and it is only when real hope (not false hope) is the guiding principle that partnering authentically with this population and their family members will be possible. In the words of Albert Einstein, “The effort to strive for truth has to precede all other efforts.”
A laser focus on the detection and preservation of truth may ultimately bring us closer to a tipping point and ultimately a long-awaited paradigm shift that embraces a stigma-free, balanced, responsible, and ethics-driven quest for an effective and safe treatment of Alzheimer’s disease and other forms of dementia. Whatever this treatment may end up being.
In the word of Gandhi,
“Truth is like a vast tree, which yields more and more fruit, the more you nurture it. The deeper the search in the mine of truth, the richer the discovery of the gems buried there, in the shape of openings for an ever greater variety of service.”
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