HOBBIES ARE GOOD FOR YOUR HEALTH

Do you have a hobby? Hobbies can give meaning and purpose to your life in retirement. As Robert Putnam points out in his book, Bowling Alone, it’s easy to discount the importance of hobbies and social engagements. Putnam details the widespread decline in civic engagement, from PTA memberships to neighborhood potlucks and bowling leagues. Over a couple of generations, Americans have misplaced the concept of free time.

SPECIAL PLANS FOR YOUR SPECIAL PEOPLE

Lily is a beautiful, active and full of personality toddler who happens to have Down syndrome. Lily’s parents and I have been friends for years and I have the continuing pleasure of watching Lily and her siblings grow up. While Lily is becoming a physical therapy rock star and hitting all her milestones in a timely fashion, her parents have started planning for the future.

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WHY WE ENJOY OUR HOBBIES

The Merriam-Webster dictionary defines a hobby as “a pursuit outside one’s regular occupation, engaged in especially for relaxation.” Hobbies include anything from playing a musical instrument to gardening, bird watching or sewing. A hobby is a way of focusing on something you enjoy just for the sake of that enjoyment. It may also be a way to clear your mental palette. You could be stressed out by a situation at work or the challenges of raising children and need an escape.

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The prescribing information for Aduhelm includes a warning for amyloid-related imaging abnormalities (ARIA), which most commonly present as temporary swelling in areas of the brain. This swelling usually resolves over time and does not cause symptoms, though some people may experience headache, confusion, dizziness, vision changes or nausea. Another warning for Aduhelm is for a risk of hypersensitivity reactions, including angioedema and urticaria. The most common side effects of Aduhelm were ARIA, headache, fall, diarrhea and confusion, delirium, altered mental status and disorientation.


Under the accelerated approval provisions, the FDA is requiring the company, Biogen, to conduct a new randomized, controlled clinical trial to verify the drug’s clinical benefit. If the trial fails to verify clinical benefit, the FDA may initiate proceedings to withdraw approval of the drug. Aduhelm was granted Fast Track designation, which seeks to expedite the development and review of drugs that are intended to treat serious conditions where initial evidence showed the potential to address an unmet medical need.


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NEW DISEASE-MODIFYING DRUG PROVIDES PROMISE FOR ALZHEIMER’S PATIENTS

for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments. Accelerated approval can be based on the drug’s effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients, with a required post-approval trial to verify that the drug provides the expected clinical benefit.


Researchers evaluated Aduhelm’s efficacy in three separate studies representing a total of 3,482 patients. The studies consisted of double-blind, randomized, placebo-controlled dose-ranging studies in patients with Alzheimer’s disease. Patients receiving the treatment had significant dose- and time-dependent reduction of amyloid beta plaque, while patients in the control arm of the studies had no reduction of amyloid beta plaque. These results support the accelerated approval of Aduhelm. The new drug is based on the surrogate endpoint of reduction of amyloid beta plaque in the brain – a hallmark of Alzheimer’s. Amyloid beta plaque was quantified using positron emission tomography (PET) imaging to estimate the brain levels of amyloid beta plaque in a composite of brain regions expected to be widely affected by Alzheimer’s disease pathology compared to a brain region expected to be spared of such pathology.

DR. THOMAS W. MILLER, PH.D, ABPP



Thomas W. Miller, Ph.D., ABPP, is a professor emeritus and senior research scientist, Center for Health, Intervention and Prevention, University of Connecticut; retired service chief from the VA Medical Center; and tenured professor in the Department of Psychiatry, College of Medicine, University of Kentucky.

Alzheimer’s disease is an irreversible, progressive brain disorder that slowly destroys memory and thinking skills, and eventually, the ability to carry out simple tasks. While the specific causes of Alzheimer’s disease are not fully known, it is characterized by changes in the brain  –  including amyloid plaques and neurofibrillary, or tau, tangles – that result in loss of neurons and their connections. These changes affect a person’s ability to remember and think.


Biogen Pharmaceuticals has gained conditional approval for Aduhelm, a drug that is a first-of-its-kind treatment approved for Alzheimer’s disease. It is the first new treatment approved for Alzheimer’s since 2003. It is also the first therapy that targets the fundamental pathophysiology of the disease.


The Food and Drug Administration (FDA), an agency within the U.S. Department of Health and Human Services, protects public health by assuring the safety, effectiveness and security of human and veterinary drugs, vaccines and other biological products for human use, including medical devices. The agency also is responsible for the safety and security of the nation’s food supply, cosmetics, dietary supplements and products that give off electronic radiation. It regulates tobacco products as well. The FDA approved Aduhelm (aducanumab) for the treatment of Alzheimer’s, which affects 6.2 million Americans. Aduhelm was approved through the accelerated approval pathway, which can be