GAP President John Dwyer spoke to THE CALL about the health disparities in Alzheimer’s research and treatment between Black and African Americans compared to whites.
If you have a family member or loved one going through Dementia you probably wish that you could turn back the clock about 15 years or to a time when they could remember who you are and in some cases who they are. But, hopefully that is about to change.
The Food and Drug Administration announced this week that it has granted approval to a drug from Biogen based on clinical research results that seemed “reasonably likely” to benefit Alzheimer’s patients.
However, according to John Dwyer, president of the GlobalAlzheimer’s Platform, it is difficult to see if clinical tests will help Black patients, because Blacks won’t participate in the clinical trial studies. “We have to make sure that these trials are inclusive trials, Dwyer said.
“Right now, it’s a matter of public record, that these trials are grossly under populated by people of color. Latinos, African Americans and Asian Americans are not in these trials to the degree that they should be,” Dwyer said.
“If I had a perfect trial i would be composed of 13 percent Latinos, 13 percent African Americans, 10 percent Asian Americans and the rest White European Americans. Now the trials are 90 percent to 92 percent White European Americans,” he said.
“I always say to our African American friends and our Latino friends, ‘You have every right to the drug, but you have to know it works for you. If we are doing a drug study and we don’t have African Americans or Latinos in the trial we don’t know if it works for you.’” Dwyer said.
Dwyer is correct. According to research data obtained by THE CALL from Us Against Alzheimer’s, blacks represent fewer than 5 percent of participants whereas they represent about 13 percent of the U.S. population.
That makes it hard to know if and how these potential therapies may work for blacks and other underrepresented groups. This makes it important to understand the biology of the disparities because it could impact the development and effectiveness of potential therapies.
“We started a trial that is de signed to get information that allows us to draw the blood from patients to determine if they have the indication for the disease. It’s just a blood test. With that test a person will be able to go to their doctor and say I had this cognitive test and this blood test and then get a determination from their doctor of what to do next,” Dwyer said.
It’s the only drug that U.S. regulators have said can likely treat the underlying disease, rather than just manage symptoms. The new drug, which Biogen developed with Japan’s Eisai Co., did not reverse mental decline. It slowed it in one study.
The FDA’s decision came despite the conclusion of its advisory committee that there wasn’t enough evidence that the drug slowed the brain-destroying disease.
However, it is unknown what the effects would be for African Americans because so few participated in the study.
The drug aims to help clear harmful clumps of a protein called beta-amyloid from the brain. The medication will be marketed as Aduhelm and is to be given as an infusion every four weeks.
According to Dwyer, the early stage drug will be available to Health Care providers such as Swope Health services, Truman Medical center, St. Luke’s and Truman in three to six months, but you have to know if the drug is appropriate for you. “It is not going to work for everyone and the drug will be expensive,” he said.
Dwyer is correct. Biogen said the drug would cost approximately $56,000 for a typical year’s worth of treatment, and it said the price would not be raised for four years. Co pays could go as high as $5,000 to $10,000 per year.
Insurers will likely request some documentation first that the patient needs the drug. Many plans will require doctors to submit records and other paperwork justifying the treatment before they agree to cover it.
Insurers also will likely re quire pre-approval for brain scans needed to determine that the patient is a candidate for treatment, said Lance Grady of Avalere Health consultants.
He stated that some plans also may want to see the results of a scan before they decide to cover the next infusion, which could delay treatment.
Understanding The Disease Dementia is the umbrella disease in which Alzheimer’s survives. They are not two different diseases. Genetics may be one contributing factor to racial disparities in Alzheimer’s disease. In the general population, inherited forms of Alzheimer’s disease account for less than 5 percent of all cases.
Among African Americans a few genes have been identified that are associated with higher risk of Alzheimer’s disease specific to this population. One is ABCA7. This gene has been demonstrated by several in dependent studies to lead to higher risk of disease in African Americans for developing Alzheimer’s disease.
The ABCA7 gene is involved in lipid transport, meaning that is important for moving lipids, or fatty acids, in the blood and the brain. However, researchers do not, yet, exactly under stand how this gene or others increases risk in African Americans.
It almost seems obvious that the higher incidences of disease, including in Alzheimer’s disease, experienced by African Americans must be related. For example, hypertension increases risk for Alzheimer’s disease, and 40 percent of African American adults have hypertension. Could it be possible that there are similar biological factors driving these high incidences in both diseases?
In one preliminary study, researchers have compared several thousands of proteins – an analysis called proteomics – in three different autopsied brain regions from African Americans and non-Hispanic whites. “We found many proteins that are related to having Alzheimer’s disease that are the same in both African Americans and non-Hispanic whites, but we were surprised to find that there were changes related to having Alzheimer’s disease that were unique to the African Americans. We have ongoing studies to replicate these findings.”
“This kind of result, though, raises a few major points. First, researchers can learn more about the biology of Alzheimer’s disease by ensuring that diverse and especially disparate groups of subjects are included in their studies. Second, the disease may behave somewhat differently underneath the surface in different populations. This is critical to know in order to develop diagnostics or therapies that can be tailored accordingly. Finally, more of these kinds of studies are necessary in order to get us closer to finding a cure for the disease.”
THE CALL will share more information on where citizens can get tested next week.
Originally posted in the Kansas City THE CALL June 11, 2021.