By Paula Hartman-Stein, Ph.D.
In January, the Center for Medicare and Medicaid Services (CMS) announced its draft decision to reimburse consumers for an Alzheimer’s disease drug, marketed as Aduhelm (aducanumab), but only to patients enrolled in research studies, setting off a firestorm of complaints, allegations and applause.
Alzheimer’s Association Chief Executive Officer Harry Johns said in a press release following the decision that “Today’s draft decision is shocking discrimination against everyone with Alzheimer’s disease, especially those who are already disproportionately impacted by this fatal disease, including women, Blacks and Hispanics.”
In clinical trials, the drug did not significantly reduce Alzheimer’s symptoms and 40 percent of participants experienced brain swelling and bleeding. Other side effects included disorientation and falls.
After weak sales and widespread criticism of its pricing, the drug’s manufacturer, Biogen, lowered its cost from $56,000 annually to $28,200.
Daniel George, Ph.D., associate professor of humanities and public health sciences at Penn State College of Medicine, wrote in a recent Psychology Today blog that the Alzheimer’s Association (AA) used emotionally manipulative tactics by alleging the CMS is creating health inequities in order to put pressure on CMS to overturn its decision.
According to George, “…the AA snapped into ‘psychopolitical’ mode, attacking the decision using the social justice tropes of contemporary identity politics (i.e., oppression, privilege, inequity). A sensible decision by CMS not to fully pay for an expensive drug with no proven benefits but clear risks was instead spun as damning evidence that the institution has been compromised by the most reviled moral specters of our time like racism, misogyny and white supremacy.”
Patients receiving the drug over 78 weeks had about a 30 percent reduction in beta-amyloid, the protein that forms plaques in the brain. Amyloid plaque is a surrogate marker of Alzheimer’s and not an accepted clinically meaningful outcome measure.
George wrote that many in the Alzheimer’s field bristled at the strong-arm tactics the Alzheimer’s Association is using on behalf of Biogen. The company has given the organization $1.4 million since 2018. The AA and other advocacy groups have flooded CMS and various social media with testimonials as to the effectiveness
of the drug.
Judith Garber, a health policy and communications fellow at the Lown Institute in Needham,
Mass. wrote in her blog, "…we don’t know if Aduhelm actually works to reduce Alzheimer’s symptoms
or progression…Restricting access to an unproven and potentially harmful drug is not discrimination,
it’s good policy."The U.S. Veteran’s Administration, as well as major insurers and health systems such
as the Cleveland Clinic, Mass General Brigham and Blue Cross Blue Shield, have also declined to pay, for the treatment.
In June, the Federal Drug Administration (FDA) approved the drug despite objections from its advisors. Following the approval, three advisors resigned. Referring to the decision, Michael Carome, M.D., director of health research for the watchdog group, Public Citizen, called the approval reckless and said the agency’s credibility has been damaged. In December, the Right Care Alliance, a group of international experts in dementia research and treatment, petitioned for accelerated withdrawal of Aduhelm by the FDA.
The petition reads in part, “We are deeply concerned about the broader issues raised by the approval of this drug. The FDA’s acceptance of amyloid plaque PET scans instead of actual patient improvement for approving drugs for Alzheimer’s disease is not scientifically well-founded. In the absence of clear evidence of meaningful clinical benefit, the continued availability of Aduhelm is likely to lead to widespread overtreatment that will not improve the quality of life of patients. It will expose them to unnecessary harms, and will consume extensive resources better spent on supportive services and public health measures to help people with this potentially devastating disease.”
CMS closed public comment on access to aducanumab on February 11 and will make its final decision on reimbursement in April.
In a recent interview, Peter Whitehouse, M.D., geriatric neurologist and chair of the aducanumab advisory committee of the Right Care Alliance, said, “Let’s not be deceived by outlandish rhetoric that those who advocate for aducanumab are representing the poor and the downtrodden; they are defending their own false promises and bottom lines. True hope lies in community and public health, not in outmoded reductionistic models of conditions like Alzheimer’s that clearly are not caused by a single factor.”
Paula Hartman-Stein, Ph.D., had served on MEDCAC, the advisory committee to CMS regarding Medicare reimbursement of clinical services. Currently, she has a psychology consulting practice and offers webinars on dementia prevention and the psychological benefits of nature and narrative. She has recently co-authored a chapter, “Preventing What’s Preventable in Dementia,” in the Handbook of Evidence-Based Prevention of Behavioral Disorders in Integrated Care. She may be reached by email at:
By Mary Eno, Ph.D.
Five-year-old Nia refuses to join her classmates for circle time. “There are too many germs there”, she says. Terence, a sophomore in high school, is sent to the dean of students’ office for cursing at his teacher, who insisted he wears his mask properly. Joel has simply refused to attend in-person middle school classes, suffering from social anxiety that intensified during the Covid-19 pandemic.
These examples are some of the school-related problems that send children and families to therapy. They are problems created, or exacerbated, by the pandemic and add complexity and challenges to the work we do every day.
Nia’s kindergarten teacher, Terence’s dean of students and Joel’s advisor are carrying an unprecedented share of responsibility for students’ wellbeing. The bottom line is that school personnel are working harder and with less support than ever before. They are trying to catch up while also trying to move forward, even as many students are falling behind.
Where do psychologists fit in?
It is well known that strong, invaluable supports are established when therapists collaborate directly with schools to help kids who are struggling. Though this is understood intuitively, working with schools can be daunting – especially when time is limited and stress levels are high.
Clinical knowledge of children and families does not always translate into knowledge about when, and how, to contact schools or collaborate with them.
One inopportune phone call could result in time-consuming meetings for school psychologists and teachers.
First, look for a teammate
When problems arise for a child at school, first ask the child or parent whom to contact at the school and how best to do it. Often, it will be the child’s teacher or advisor and sometimes it will be someone from the school’s student support team. At that time, it is important to secure proper permission and documentation to facilitate the connection. Mindset matters, so this person should be approached as someone with whom you have the privilege and opportunity to solve these problems.
Listen, learn and take every opportunity to strengthen the family’s relationship with the school. In preparing for the call or meeting, ask yourself:
· Why am I calling?
· What specific questions do I have about the child?
· What do I need to know about your school to help this child?
· What does the school need to know about my professional background and the work I am doing with the child?
Reach out in a spirit of collaboration
Approach the school with the intention of goodwill. Assume educators are trying to
do the best thing for their students. If it’s not happening, it may be because they lack the
skills or knowledge or are overwhelmed by the circumstances.
When reaching out, start with, “How can I help and how can I be most supportive?” Educators are most likely to hear this as a constructive gesture, rather than something judgmental or confrontational.
With school communities facing uncommon antagonism and conflict – whether driven by fear, the pandemic, politics or fatigue – psychologists can step in with a spirit of collaboration and intention to solve problems.
Fill in the gaps
Remote learning and the complexities of returning to in-person schooling made it harder to figure out what’s going on with kids who struggle. Yet both sides can work together to fill in crucial gaps that might have widened during the pandemic. School personnel can give psychologists important information that helps them serve young clients better. Psychologists can share their impressions and concerns, joining with those who work with the child every day. School is a vital component of children’s lives, and the most effective treatment of their problems calls for schools and psychologists to work together.
Attend family-school meetings
Attending family-school meetings, whether online or in person, is more important than ever. Yet, in the context of the Covid-19 pandemic, psychologists need to be even more deliberate and persistent.
For example, if you plan to participate in a family-school meeting online and were hoping to informally touch base with the teacher beforehand, this will need to be scheduled. If you anticipate tension or hostility in a meeting, it may be important to prepare with the parents beforehand and/or schedule a meeting or phone call with a trusted school representative in advance, rather than try to come up with solutions on the fly.
When the meeting begins, clarify the issues and ensure that the goals are explicit. For example, you might confirm who is facilitating the meeting and share your views on what you’re hoping to accomplish to set the tone for others to do the same.
When meetings come to an end, be sure key takeaways are summarized and review the shared understanding and plans that were developed.
Build communities of support
When psychologists reach out to schools, they start thinking more expansively and creatively.
More than ever now is the time to bring clinical skills to a child’s school-related problems and collaborate with school representatives to help build communities of support for vulnerable children and families, fostering hope and harnessing goodwill.
Mary Eno, Ph.D., has been a member of the teaching faculty at the University of Pennsylvania and Bryn Mawr College for several decades. She is a psychologist in private practice in Philadelphia and has served as a consulting psychologist throughout her career. She is the author of The School-Savvy Therapist: Working with Kids, Families and Schools, published by Norton & Company. She may be reached by email at firstname.lastname@example.org.
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