Personal Blog #12 … More Data on Aducanumab … 12/10/19

According to an article published by The Associated Press on December 5, 2019 Biogen’s scientists issued a preliminary report on their new data analysis of their Alzheimer’s disease (AD) medication, aducanumab.  This is the medication that was in a Phase III clinical trial that was ended in March due to poor results but, after new data came in after the trial ended, was then promoted by Biogen as being effective.

Biogen’s presentation received very mixed reactions from scientists at an Alzheimer’s conference in San Diego, California on 12/5/19.  According to the A.P. article, scientists were “sharply divided over whether there’s enough evidence of effectiveness for the medicine to warrant federal approval.”  The new data released that day indicated that “the drug made only a very small difference in thinking skills in one study and none in the other.”  A.P. reports that independent experts said that “the new analyses were done on partial results, and with methods not agreed upon at the outset, making any conclusion unreliable.”

Some scientists cheered the new results and some judged them insignificant.  “Questions arose about the size of any benefit.  The drug did not reverse decline and it only slowed the rate of it compared to the placebo group by 22% in one study.  Yet that meant a difference in only 0.39 on an 18-point score of thinking skills.”

As I’ve written many times before, the currently FDA-approved AD medications have been shown to be effective for only about 50% of the people who take them, and then only for up to a year or two at most.  But, sadly, once doctors place their AD patients on these expensive medications, doctors are reluctant to ever remove their patients from these meds …  even though there is absolutely zero research to indicate that these meds have been or still may still be effective.  The result is that too many caregivers and AD patients continue to pay a lot of money year after year for AD meds that I refer to as “expensive bottles of hope” when that money could be much better used for day care, respite opportunities, or to help pay for home or institutional care.

I sincerely hope that, if this is the best new data Biogen can present to the FDA in support of their application to market aducanumab, the FDA resoundingly says no to marketing at this point.  If Biogen scientists think their data suggests promise, then let them conduct new year-long Phase III clinical trials with proper supervision.  That is the only way to demonstrate effectiveness.  Scoring one point more on a test of thinking skills is no reason to add yet another expensive bottle of hope to the market.

Personal Blog #11 ... Is Aducanumab an Effective Treatment for Early Stage Alzheimer's? ... 11/2/19

Of the top 10 causes of death in this country, Alzheimer’s disease (AD) is the only one with no effective means of prevention, treatment or cure. Any pharmaceutical or biotech company that discovers medication to effectively treat, let alone prevent or cure AD, will help millions of people … and make millions of dollars.  We often see reports of successful Phase I or Phase II clinical trials demonstrating positive effects of new experimental AD medications, but we have yet to see reports of effectiveness in a Phase III clinical trial.  The National Institutes of Health (NIH) describes the different phases of clinical trials as follows:  (Note: the NIH website may be accessed at … https://www.nia.nih.gov/health/what-are-clinical-trials-and-studies.)

"Clinical trials advance through four phases to test a treatment, find the appropriate dosage, and look for side effects. If, after the first three phases, researchers find a drug or other intervention to be safe and effective, the FDA approves it for clinical use and continues to monitor its effects.

Clinical trials of drugs are usually described based on their phase. The FDA typically requires Phase I, II, and III trials to be conducted to determine if the drug can be approved for use.

• A Phase I trial tests an experimental treatment on a small group of often healthy people (20 to 80) to judge its safety and side effects and to find the correct drug dosage.
• A Phase II trial uses more people (100 to 300). While the emphasis in Phase I is on safety, the emphasis in Phase II is on effectiveness. This phase aims to obtain preliminary data on whether the drug works in people who have a certain disease or condition. These trials also continue to study safety, including short-term side effects. This phase can last several years.
• A Phase III trial gathers more information about safety and effectiveness, studying different populations and different dosages, using the drug in combination with other drugs. The number of subjects usually ranges from several hundred to about 3,000 people. If the FDA agrees that the trial results are positive, it will approve the experimental drug or device.

A Phase IV trial for drugs or devices takes place after the FDA approves their use. A device or drug's effectiveness and safety are monitored in large, diverse populations. Sometimes, the side effects of a drug may not become clear until more people have taken it over a longer period of time.)"

Biogen, a major biotech company, ended its Phase III clinical trial with a new experimental medication, aducanumab, on March 21, 2019 because testing results indicated that it was ineffective.  So how is one to interpret Biogen’s announcement on October 22, 2019, that it will ask the FDA to approve aducanumab as a new treatment for early stages of AD? 

On their website, www.biogenalzheimers.com, Biogen states that after their study ended in March, “a new analysis of a larger dataset” showed that … “Patients who received aducanumab experienced significant benefits (my underlining) on measures of cognition and function such as memory, orientation, and language.  Patients also experienced benefits on activities of daily living including conducting personal finances, performing household chores such as cleaning, shopping, and doing laundry, and independently traveling out of the home.”  Biogen plans to submit their new data to the FDA in early 2020 to seek approval to market aducanumab.  

If the FDA determines that Biogen’s data support aducanumab as an effective treatment to slow the effects of AD, that would be a major step forward and offer tremendous hope to people with AD and their caregivers.  But before I get too excited, I want to see that results reported as “significant benefits” are what I refer to as “real world” benefits.  Reports of “statistically significant” results on paper/pencil tests measuring cognition, or of brain scans or biomarkers measuring a decrease in amyloid beta protein in the brain, are always welcome. 

However, such measures do not necessarily translate into more effective patient functioning at home or in a facility.  Answering 1 or 2 more questions correctly on a cognitive test or remembering 1 or 2 more words on a memory test may yield “statistically significant” results but may not always mean more effective functioning in the real world.  However, medication resulting in significant improvement for people with AD for 6-12 months or longer as they deal with activities of daily living or who can continue to go shopping or travel independently outside the home … to me, that would be a major game changer.  Such benefits would allow the person with AD to enjoy a much better quality of life for a much longer period of time. 

If Biogen follows through on its current plans, this will the first time that a company has ever ended a “failed” Phase III clinical trial of an experimental AD medication … then re-analyzed additional data … then claimed that this additional data support effectiveness of its medication … and then requested submission to FDA for approval to market.  After reviewing the research findings submitted by Biogen, the FDA can approve the medication, reject the medication, or find some evidence of effectiveness … but not conclusive enough evidence to warrant approval … and require additional clinical trials.

As a former AD spouse caregiver, I hope that the FDA will concur that aducanumab can be that major AD game changer after reviewing data submitted by Biogen.  But, until the FDA makes a decision, I will remain skeptical.  Biogen announced that it plans to report their new data and seek approval from the FDA in “early” 2020.  Stay tuned!

Personal Blog #10 … Life After Moving On … 9/2/19

I didn’t expect to write anything else for this site after posting Personal Blog #9 last December.  I wrote in that posting, “Now that I have moved out of my comfort zone and moved on with the rest of my life, I don’t think I will have anything new to write about that could be helpful to others.”

I have moved on quite a bit … but not as completely as I had hoped.  I still miss Clare a lot, and every week I experience some degree of sadness, loneliness, and painful feelings of loss.  This site has received more than 100,000 visits since my first postings in 2013, so I’m hoping that site visitors who may also be struggling to fully move on and find happiness will read this and know that they are not alone.  I, too, am continuing to struggle.

In March, 2015, a year before Clare died, I wrote an article titled, “An Alzheimer’s Spouse … Married, Yet Widowed.”  As I watched Clare fading away from me faster and faster, I wrote: “I miss not having conversations with Clare.  We can no longer play games, travel … I miss all of the social, emotional, and physical parts of our once close relationship.”

Sadly, I could write those same words today.  During this past year I was lucky enough to have someone in my life who, while not fulfilling all my wants and needs, provided me the hugging and cuddling I have missed so much.  That alone gave me great happiness … but, unfortunately, that relationship was very short-lived.

I don’t expect to ever find “another Clare,” but I do hope to find a special woman to share the social, emotional, and physical aspects of a close relationship.  Such a special woman would add much happiness to my life and reduce my sadness and loneliness.

Contributing to my continuing sadness is my inability to focus only on positive memories of Clare.  Our last years were so emotionally painful that whenever I try to remember only the “good times,” my mind is quickly flooded with images of Clare after AD had already ravished her brain and body.  These are images I so much want to forget … but I seem unable to do so.  I just cannot block them out.

To keep feelings of sadness partially suppressed, there are TV shows and movies I will not watch, and music I will not listen to.  Watching loving couples on a TV show or in movies, whether enjoying life to the fullest or dealing with death, too often makes me cry.  Similarly, listening to some favorite old songs will often make me miss Clare so much that I just start crying.

Hoping to meet a special woman, I have been sampling more new clubs and activities for seniors at community centers and libraries.  Last year I joined an internet dating site, but I didn’t participate because I just wasn’t ready yet.  In recent months, however, I have been actively participating on multiple online dating sites.

These efforts have enabled me to meet several nice women … but not yet the right woman for me.  Many friends have suggested that I’ve set the bar too high, but I don’t think so.  Only a special woman will provide me with the relationship I really want. 

I know what I’m not looking for … I’m not looking for a friend “with benefits.”  I will never have sexual intercourse again. It may not make sense to others, but sex with another woman would feel like a betrayal of the incredibly special love Clare and I once shared.  However, whereas I am not looking for a friend with “full benefits,” a friend with “modified benefits” would be wonderful.

AD widows and widowers of all ages need to find new happiness in their lives.  Making new friends, pursuing old passions, and exploring new hobbies and activities are some ways to do this.  But for some what is needed most is a new close relationship to once again enjoy some aspects of the marriage they once had … a “second act” that will provide more happiness, less sadness, and less loneliness.

 

I have moved on quite a bit since Clare passed away, and since writing Personal Blog #9 last year.  The quality of my life is better now.  But … I am still hoping to have that second act.