2021 was a groundbreaking year for health and medical breakthroughs. While a lot of effort and time went into understanding more about the evolution of COVID-19 and developing vaccines and medications to fight it, our researchers and scientists also took significant steps in several other medical areas even as the most deadly pandemic of our time raged on.
From developing milestone medicines for Alzheimer’s disease to getting the first-ever knee replacement with a smart implant, here are some of the most significant medical breakthroughs — both large and small — from the past year.
1. A Blood Test to Detect Early Cancer
A recently developed blood test can help detect cancer early. As you might be aware, early detection is the key to surviving cancer. However, only a few tests such as Pap smears, mammograms, lung screenings, and colonoscopies exist currently that can help detect the disease at its most curable stages. The Galleri test can change the game. The new blood test uses genetic sequencing technology and artificial intelligence to alert a doctor if you have a signal for the disease and points out which organ it comes from. The test has the potential to detect more than 50 types of cancer.
In a study published in Annals of Oncology, researchers analyzed 4,077 participants (2,823 of whom had cancer) to test the Galleri test’s efficacy. They found that the overall sensitivity for cancer detection was 51.5%, which increased with the tumor stage. More importantly, the test managed to successfully predict the location of the tumor about 89% of the time. A much larger trial involving 140,000 people aged 50 to 77 years will follow soon where all the participants will have their blood analyzed over a period of 2 years.
2. First Injectable HIV Prevention Drug
The Food and Drug Administration (FDA) has recently approved the first long-acting injectable medication for use as pre-exposure prevention against HIV. The new drug, named Apretude, is an injectable that will be given every two months as an alternative to HIV prevention pills. Two FDA trials to analyze the safety and efficacy of the novel drug have been undertaken so far. The results showed that the participants who took Apretude had significantly reduced chances of contracting HIV when compared to people taking daily oral medications - by 90 percent for cisgender women and by nearly 70 percent for cisgender men and transgender women who have sex with men.
This could be a milestone in HIV prevention and can prove to be critical to addressing the HIV epidemic in the U.S., says the FDA. While the use of PrEP (pre-exposure prophylaxis) – a medicine taken to prevent getting HIV – has helped, the Centers for Disease Control and Prevention data shows that about only 25% of the 1.2 million people for whom PrEP is recommended were prescribed the treatment last year. This new long-acting injectable can make adherence easier because it’s a medication that one can take only once every 2 months at a doctor’s office. Experts say that since people tend to attend a doctor’s appointment while often forgetting to take medications at home, Apretude can help increase PrEP usage and bring down the HIV rate worldwide.
3. Low-Cost Over-The-Counter Hearing Aids
When you can’t understand what your grandkid is saying over the phone, a hearing aid can help make things easier. However, these devices are quite costly. Once you include the fee of a hearing-health professional to them, who you have to see, hearing aids can easily touch thousands of dollars for a pair. Thankfully, the FDA has recently proposed the creation of a new category of over-the-counter (OTC) hearing aids that will be sold directly to the millions of people in need of them. The proposed rule aims to promote the wide availability of low-cost hearing aids to the average person. An estimated 38 million American adults suffer from mild to moderate hearing loss. Having more affordable hearing aid options will certainly make life easier for them.
4. First-Ever Knee Replacement with "Smart" Implant
The first-ever knee replacement using a smart implant was successfully completed in October last year. The implant, called the Persona IQ, provides remote, automatic internal medical data through a small “smart” stem extension attached to the bottom portion of the implant. This stem contains sensors that measure data points such as the number of steps taken, walking speed, range of motion, stride length, etc., and sends the information back to the orthopedic surgeon to track recovery.
Persona IQ received FDA approval in August 2021 and industry experts believe that this could trigger the beginning of a smart implant revolution. They could improve health outcomes and provide patients with detailed information about their bodies. These devices could also help result in the personalization of physical therapy plans.
5. The Most Affordable Insulin Ever
Approximately 537 million adults are living with diabetes currently, according to the International Diabetes Federation. For a lot of them, insulin – an essential hormone produced by the pancreas that helps process glucose – is important for survival. But the cost of the manmade version of human insulin unfortunately is absurdly high today. There's some good news on that end.
The FDA has recently approved Biocon Biologic's Semglee insulin glargine (a long-acting human insulin analog to enhance glycemic control) as a new and affordable basal insulin for adults and children with type 1 diabetes and adults with type 2 diabetes. It has been designated as “interchangeable biosimilar” insulin. A biosimilar is a biological therapy having highly similar safety and efficacy to the brands that are already FDA-approved and on the market but has "no clinically meaningful differences." It’s basically a generic medication that pharmacists are allowed to substitute for a name-brand drug, but it doesn’t need prior approval from a doctor to make the swap.
Semglee costs $148 for five pre-filled insulin pens (3 mL each) and is administered subcutaneously (under the skin) once daily. For people who are uninsured or underinsured, or don’t qualify for patient assistance programs, Semglee can become an affordable option.
6. A Milestone for New Medicines for Alzheimer’s Disease
In what is a significant landmark for new medicines for Alzheimer’s disease, Biogen's Aduhelm has become the first new Alzheimer's drug approved by the FDA in nearly 20 years. It’s also the first drug cleared in the U.S. to slow cognitive decline in people with Alzheimer's.
“It is a new day,” Harry Johns, CEO of the Alzheimer’s Association, said in a statement. “This approval allows people living with Alzheimer’s more time to live better. For families, it means being able to hold on to their loved ones longer. It is about reinvigorating scientists and companies in the fight against this scourge of a disease. It is about hope.”
Aduhelm’s efficacy was evaluated in three separate studies that included a total of 3,482 patients with Alzheimer’s disease. Researchers found that the treatment significantly reduced dose-and time-dependent amyloid-beta plaque in the brain—a hallmark of Alzheimer’s disease. Meanwhile, patients in the control arm of the studies showed no reduction of amyloid-beta plaque.
Previously, there were no drugs cleared by the FDA that can slow the mental decline from Alzheimer’s. Almost 44 million worldwide are estimated to be living with Alzheimer’s disease, the most common cause of dementia. Aduhelm could be a game-changing moment for them.
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