This week’s Bulletin discusses the controversy regarding a new drug approved in early June to treat Alzheimer’s disease called Aduhelm (aducanumab). There is serious division in the FDA around the drug’s effectiveness, yet it was still approved via the FDA’s ‘fast track” – what’s this controversy about?
Treating Alzheimer’s Disease
Alzheimer’s disease causes nerve cell death and tissue loss throughout the brain. Over time, the brain shrinks dramatically, affecting nearly all its functions. Scientists can also see the damaging effects of Alzheimer’s disease in brain tissue when they see “plaques and tangles“.  The brain cell transport system is made of protein strands including a protein called tau needed to keep the transport system strands straight. Dead and dying nerve cells contain tangles which then stop the nutrient transport system so brain cells eventually die. The plaques are abnormal clusters of beta-amyloid protein fragments that build up between nerve cells.

These plaques and tangles are the hallmark characteristics we see in the brain tissue of Alzheimer’s disease patients, but the precise causes of Alzheimer’s disease are not fully understood. There is still some debate in the scientific community around whether these amyloid beta plaques and the tau tangles are the cause of the cognitive impairment in Alzheimer’s patients or are these just the end result of the damaged brain tissue that we physically see, but not what is actually causing the cognitive decline.

Aducanumab is an antibody infusion from cloned immune cells (called “monoclonal antibodies”) that  binds to amyloid beta tangles and reduces them. The “amyloid hypothesis” says that reducing the plaques will improve cognition, but this had not been shown to work in any other drugs that went for FDA approval – aducanumab became the first.

While aducanumab doesn’t reverse or cure dementia, it may slow the loss of memory and general cognition (thinking ability) that are hallmark symptoms of Alzheimer’s disease. Critics of aducanumab say that a closer look at the data from trials shows cognitive improvements might be overblown or unrelated to the drug itself plus there’s still the debate over whether targeting amyloid-beta plaques in the brain is what actually improves dementia symptoms.

The bottom line is that some people question whether or not aducanumab works. In 2020, an advisory board of experts unanimously agreed (10-to-0) that aducanumab should not be approved as effective against Alzheimer’s disease. In the EMERGE trial, patients who got the highest dose of aducanumab experienced a 22% improvement on a clinical dementia scale over placebo after 78 weeks, the company reported. Yet the same patient group in another study did worse than placebo on that same measure.  Even with the slight improvement shown in one study, critics say that the evidence is “insufficient to be able to demonstrate that patients get benefits that would outweigh the risks”.

In June 2021, it was approved anyway by the FDA under their “accelerated approval” designation. Accelerated approval is for drugs that can help with serious illnesses but also need more study – if there is not more evidence in this latest phase that aducanumab is effective for treating symptoms of dementia, the drug might be pulled off the market.

The U.S. Food and Drug Administration’s controversial approval of a new Alzheimer’s drug, along with its high price, is now being investigated by two House committees. “We have serious concerns about the steep price of Biogen’s new Alzheimer’s drug Aduhelm and the process that led to its approval despite questions about the drug’s clinical benefit,” House Democrats Carolyn Maloney and Frank Pallone Jr. said in statement from the Committee on Oversight and Reform and the Committee on Energy and Commerce, CNN reported.

The price tag is unfortunately expensive, at around $56,000 per year, but the drugmaker Biogen has said it is working with insurance companies to make out-of-pocket costs much less for those who need it. The drug is an infusion which means it’s given by IV in a doctor’s office or infusion center over many months.

Patients taking aducanumab have experienced swelling and bleeding in the brain, a side effect called “amyloid-related imaging abnormalities” (ARIA). During trials, ARIA was detected in 41% of people taking aducanumab, compared to 10% of those in the control group who did not take the drug. The drugmaker recommends MRI scans that detect ARIA before the 7th and 12th infusions, as the problems typically develop in the first 12 to 16 weeks of treatment and are asymptomatic.

Three of the advisory committee members resigned after the FDA approved the drug. Dr. Aaron Kesselheim, a Harvard Medical School professor and Brigham and Women’s Hospital physician, was one of them. In his resignation letter, he called it “the worst drug approval in US history.”

Covid remains a serious threat to unvaccinated adults. Cases have begun to rise more rapidly in communities with lower vaccination rates. This chart looks at the number of new cases in counties across the U.S. and the share of residents who have been fully vaccinated. 

COVID UPDATES

  • The Pennsylvania Department of Revenue announced that effective July 1, if an employee is working remotely from his or her home, such home location must be treated as the employee’s work location for purposes of sourcing his or her compensation and for corporate net income tax and sales tax nexus purposes.

 

  • Lawmakers made a final vote Thursday to approve a bill to let parents decide whether to have their children repeat a year of school, a measure designed to help children catch up after a year of schooling disrupted by the pandemic. The Senate voted 50-0 for the proposal, which also would permit students in special education to return for another year, even if they have reached the maximum age of 21. Under the bill, parents would have to decide by July 15 whether their child should repeat a grade. Students would be able to participate in extracurricular activities but they would not get another year of eligibility to play sports if they have already maxed out.
  • The Biden administration is planning a 1,000-person Fourth of July celebration on the White House lawn with essential workers and military personnel, partly to celebrate the United States’ success in driving down COVID-19 cases. “Right now it’s an appropriate time to step back and celebrate the progress we’ve made; at the same time, we’ve got a lot more work to do,” Zients said.
  • Unvaccinated people now account for nearly all COVID-19 hospitalizations and deaths in the United States, federal government figures show. On Tuesday, CDC Director Dr. Rochelle Walensky said COVID-19 vaccination is so effective that “nearly every death, especially among adults, due to COVID-19, is, at this point, entirely preventable,” and called such deaths “particularly tragic,” the AP reported. U.S. COVID-19 deaths have dropped dramatically from a mid-January peak of 3,400 per day.
  • The speedy U.S. vaccination campaign has dramatically reduced COVID-19 cases among residents. The peak seven-day-average of more than 250,000 cases per day in January fell to around 11,000 in mid-June. But daily cases are rising driven by case increases in the Midwest and Southeast where vaccination rates are low and where the highly contagious Delta variant is spreading amongst the unvaccinated.
  • Recent studies suggest that existing vaccines are highly effective against the Delta variant. The protection is strongest in those who received both doses of two-dose shot regimens, such as those made by Pfizer and Moderna. Both shots, which have been the mainstays of the United States vaccination campaign, have been shown to be highly effective against the original variant COVID-19 and several newer variants. Ongoing studies look promising for the J&J vaccine to provide the same protection against the variants.
  • There are likely to be outbreaks this fall and winter in unvaccinated pockets of the United States, resulting in more preventable deaths, experts predict. Some states will be more vulnerable than others. For example, only about 33% of Arkansas’ population is fully vaccinated — one of the lowest rates in the country — and cases, hospitalizations and deaths are already on the rise in that state.
 
  • The Pfizer and Moderna vaccines trigger an immune system response that could fend off the coronavirus for years to come, new research reveals. The latest study bolsters growing evidence that most people immunized with the mRNA vaccines may not need booster shots, with one key caveat: That the virus and its variants don’t evolve too much beyond the virus’ original form.

 

  • Studies have shown that only receiving one dose of the two-dose vaccines is much less effective against the Delta variant than getting both doses. More than 1 in 10 Americans have missed their second dose of a coronavirus vaccine, a troubling trend as the more infectious Delta variant gains a foothold in this country. Experts warn that the Delta variant may soon become the dominant strain in the United States.

 

  • Predators worldwide took advantage of pandemic restrictions last year to draw more people into forced labor and sex trafficking according to a new State Department report. In the United States, tenants who could not afford to pay rent were pressured into having sex with their landlords. In particular, the number of cases of online sex exploitation appeared to skyrocket as people turned to their computers during lockdowns. The report found that predators increasingly recruited and groomed children — who were spending more time online, often without supervision — for sex trafficking and sexually explicit material. In the United States, the National Center for Missing and Exploited Children reported a 99 percent increase in children being enticed by online predators between January and September last year.

 

  • In 2018, average life expectancy in the U.S. was about 79 years (78.7). It declined to about 77 years (76.9) by the end of 2020, according to a new study published in the British Medical Journal. Beyond the more than 600,000 deaths in the U.S. directly from the coronavirus, other factors play into the decreased longevity, including disruptions in health care, disruptions in chronic disease management and behavioral health crisis, where people struggling with addiction disorders or depression might not have gotten the help that they needed.

 

  • While Americans are gradually getting back to some semblance of normal, traffic data suggests that the morning drive has changed drastically – and it may never go back to pre-COVID-19 patterns. In short, rush-hour traffic is more spread out and, generally, has shifted later in the morning as Americans are more able to avoid heavy traffic periods due to remote work, according to traffic data analyzed for USA TODAY by Wejo, which tracks data from connected vehicles.

 

  • After a year of virtual living during the COVID-19 pandemic, younger generations feel online presence is more important than real-life interactions, a study released Thursday shows. The survey finds that 60% of Generation Z and 62% of millennials say that how you present yourself online is more crucial than how you appear in person.  The survey found that among Gen Z and millennials, virtual life is more memorable. Nearly half, 49%, of Americans say they could better remember the color of a website than the color of someone’s eyes; 71% of millennial and 58% of Gen Z respondents agree. Members of Gen Z are more likely to remember off the top of their head the last website they visited (43%) than their partner’s birthday (38%) or their own Social Security number (31%).

 

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Dr Bralow

Dr. Vicki Bralow
834 South Street
Philadelphia, Pa 19147

215-832-0135
DrBralow@mdvip.com