I recently blogged about Biogen Inc. and the drug in development that is said to be the first treatment that could show decline in people with Alzheimer’s disease.
Since I wrote about this in November, 2020, Biogen has continued working towards the coveted regulatory approval from the U.S. Food and Drug Administration (FDA).
Despite a panel of experts at the FDA voting against the drug in November, 2020, the FDA has extended the review period of the drug by three months. For reference, the panel voted “no” to three questions related to whether a single successful large trial of the drug was sufficient evidence of the drug’s effectiveness, given the clear failure of a second large study.
Although the FDA is not obligated to follow the recommendations of the panel, it usually does.
Notwithstanding the FDA’s history of following the panel’s recommendations, this extension raised some hopes that the drug may still be approved which reflected in an increase of Biogen’s shares by 8% premarket.
Obtaining regulatory approval would certainly be of benefit to the shareholders of Biogen. However, if the drug is actually effective, it would certainly change the lives of many people afflicted with Alzheimer’s today.
Stay tuned for more updates!
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In estate litigation, we often hear about Alzheimer’s and how it can affect the daily lives of so many Canadians. Unfortunately, there is no treatment for Alzheimer’s at this time, other than medication that can be taken to (hopefully) slow its effects and prolong one’s quality of life.
Interestingly, Biogen Inc. has been working on what has been labelled a “controversial” new drug called “Aducanumab”. The controversy is, first of all, the rather bumpy ride this new drug has had with the U.S. Food and Drug Administration (FDA) and the regulatory approval that this treatment needs in order to be made available to consumers.
According to Biogen, if this drug receives regulatory approval, it will become the first treatment to slow decline in people with Alzheimer’s disease.
The problem is that to date, it is not clear as to whether there is “substantial” evidence of effectiveness which is what is required in order to gain the coveted regulatory approval that allows the drug on the market.
A recent update is not positive for Biogen as an independent advisory committee to the FDA found that the clinical data does not show the drug to be effective for the treatment of Alzheimer’s disease.
I am sure this is not the outcome desired by Biogen strictly from a financial perspective but it is certainly not a positive outcome for the many people affected by Alzheimer’s today.
Here is to hoping that if this treatment does not prove to be successful, that another one becomes available soon.
To learn more about recent updates on Biogen Inc. here is an article from November 10, 2020.
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America’s Top Forty show was hosted for decades by Casey Kasem and was one of the top radio shows in the world. Casey was born Kemal Amin Kasem in Detroit on April 27, 1932 to Lebanese immigrant parents who worked as grocers. He succeeded on radio and also did other work like voice roles in cartoons like “Shaggy” on Scooby-Doo. When he died on June 15, 2014 at age 82 his estate was reported to be valued at over $ 80 million USD.
After his death, three children from his first marriage were involved in what can only be described as a very sad dispute with his second wife that went on for over 5 years. The dispute was recently reported to have been settled in December 2019. This, in my view, is another example of what goes wrong when proper estate planning is not considered by parents/spouses/children. The ensuing consequences are often unfortunate and can be played out, in large part, in the courts. There is too much to the Casey Kasem story for this blog but, the story involves his dementia from Lewy Body Disease, one of the most common progressive dementia’s after Alzheimer’s. It involves his disappearance and a Los Angeles court declaring him a missing person on May 12, 2014. It involves his not being buried for six months after he died and then being buried in Oslo Norway for some reason on December 16, 2014. For more on this story I suggest the article by Amy Wallace entitled “The Long, Strange Purgatory of Casey Kasem”.
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These days, life expectancy is longer than ever. We have previously blogged (for instance, here and here) about some considerations and consequences of having a longer life expectancy. A recent article in The New Yorker considers aging, and in particular, anti-aging now that people are generally living longer. The online version can be found here: Can We Live Longer but Stay Younger?
One of the problems with living longer, as highlighted in the New Yorker article, is that we still must deal with the challenges and realities of aging. What we really want is not eternal life but rather, eternal youth.
The article discusses several efforts to address or counteract the types of issues that we face as we age. For instance, a geneticist at Harvard has successfully extended the life of yeast, and is moving on to human trials. A Harvard molecular biologist, George Church, has had success reprogramming embryonic stem cells to essentially turn an old cell into a young cell. Church’s work has been done so far on mice and dogs, but there are plans to commence human clinical trials within the next five years.
The goal of the work being done by Church is to live better, not necessarily longer: “The goal is youthful wellness rather than an extended long period of age-related decline.” The article discusses the nature of this age-related decline, through the illustration of a “sudden aging” suit that allows the wearer to experience the physical challenges of aging, including boots with foam padding to produce a loss of tactile feedback, and bands around the elbows, wrists, and knees to simulate stiffness. The point of the aging suit is to help create empathy and understanding about how difficult each and every task (an example was reaching up to a top shelf and picking up a mug) can be for older adults, both physically and mentally. So the question becomes, if we are living so much longer, but with age, every day and every task becomes much more difficult, what can we do to counteract that?
The work being done related to anti-aging and the creation of products to make older people’s lives easier is interesting and seems to be moving in new directions. For instance, the article mentions the difficulty of marketing certain products aimed at older people, because we do not like the idea of buying something that reminds us that we are old. So instead of selling a personal-emergency-response system to send an alert and seek assistance in the event of a fall, or some other physical emergency, in the form of a pendant worn around the neck, it is suggested that the most effective such device would be an iPhone or Apple Watch app.
Unfortunately, the issue of dementia is still a concern. There still does not appear to be a cure in sight for Alzheimer’s or other forms of dementia. The causes remain unclear. The effects, however, are evident. One of the individuals mentioned in the article was Professor Patrick Hof, who studies brains. On the physical effects of dementia on our actual brains, Professor Hof notes that “[y]ou can’t tell any difference, even under extreme magnification, between an aging non-demented brain and a younger human one…But, holding an Alzheimer’s brain in your hand, you can see the atrophy.” It appears that there is still a lot of work to be done in this area, in particular.
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An Attorney for Personal Care and a Guardian of the Person is statutorily mandated under section 66(3) the Substitute Decisions Act, 1992 (the “SDA“) to make certain decisions in the incapable person’s best interests if the incapable person’s wishes and instructions are unknown or if it is impossible to act in accordance with those wishes and instructions.
A component of the best interests analysis, as set out in section 66(4), includes considering whether the guardian’s decision is likely to,
“i. improve the quality of the person’s life,
ii. prevent the quality of the person’s life from deteriorating, or
iii. reduce the extent to which, or the rate at which, the quality of the person’s life is likely to deteriorate.”
Given that improving the quality of a person’s life and preventing their quality of life from deteriorating are two sides of the same coin, there is exciting and heart-warming new technology which uses Google Street View to treat Alzheimer’s patients.
This new technology is a prototype called BikeAround. BikeAround is essentially a stationary bike that stimulates the experience of, literally, biking down memory lane for an Alzheimer’s patient. The patient is placed on a stationary bike which faces a projection of his/her familiar hometown streets from Google Street View. The experience is intended to prevent memory loss by bringing to mind locations that are associated with the patient’s memories. The simultaneous physical stimulation from the act of biking is also considered to be a crucial component of the benefits from this new technology.
Anne-Christine Hertz is the biomechanical engineer who developed BikeAround.
This video on Hertz’s research is not to be missed.
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Tomorrow marks the end of World Alzheimer’s Month, a campaign to raise awareness and challenge the stigma surrounding dementia.
MP Lisa Raitt marked the occasion this month by making a member’s statement in the House of Commons. In her statement, she noted the 564,000 cases of Alzheimer’s disease in Canada, and the 25,000 newly diagnosed cases each year: one of which was her husband Bruce Wood in 2016 at the age of 56. Raitt stated that the diagnoses presents significant challenges, but that “living with dementia can be okay”.
Alzheimer’s Disease International states that the stigmatization and misinformation that surrounds dementia remains a global problem, and that 2 out of 3 people globally believe that there is little or no understanding of dementia in their country.
Canada appears to be making progress in addressing some of the issues surrounding Alzheimer’s disease. In June, 2017, Bill C-233, the National Strategy for Alzheimer’s Disease and Other Dementias Act, received Royal Assent. The Act requires the federal Minister of Health to develop a comprehensive national strategy to address all aspects of Alzheimer’s disease and other forms of dementia. Within 6 months, the Minister of Health must convene a conference with her provincial counterparts and other stakeholders for the purpose of developing the national strategy. The Minister is to report to Parliament within two years of the proclamation of the Act.
As another resource, the Alzheimer Society Canada website is an excellent tool for raising awareness and a better understanding of the disease, with detailed information about dementia and Alzheimer’s disease, and living with the disease.
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