One of the biggest drug decisions in decades is looming as U.S. regulators consider whether to approve the first medicine that’s claimed to slow mental decline from Alzheimer’s disease, the most common form of dementia.
A panel of outside experts meets Friday to advise the Food and Drug Administration on aducanumab, a drug from Cambridge, Massachusetts-based Biogen Inc. and Japan’s Eisai Co. FDA doesn’t always follow the panel’s advice but usually does and has until March to decide.
The drug does not cure or reverse Alzheimer’s; the claim is that it modestly slows the rate of decline.
The evidence is murky: The companies stopped two studies last year when the drug didn’t seem to work, then did an about-face and said additional results suggest it was effective in one study at a high dose. Results still have not been published.
An FDA staff report released Wednesday gave a generally glowing view, saying the positive study might be “exceptionally persuasive.” But an FDA statistician noted flaws and inconsistencies in the results and potential safety issues.
The drug is expected to be very expensive and “could bankrupt our health care system” while giving patients false hope, the consumer group Public Citizen warned.
More than 5 million people in the United States and many more worldwide have Alzheimer’s. Current drugs only temporarily ease symptoms and the last one was approved nearly two decades ago.
The FDA evaluation focuses on safety and effectiveness. But advocates for approval, including the Alzheimer’s Association, are pushing to make need part of the decision.
“There is a dire and drastic need” to help people impacted “by the crushing realities” of the disease, the association wrote to the FDA. The association got $450,000 from Biogen and Eisai last year, less than 1% of its total revenue.
Others say the need for a drug has no bearing on whether it works or is safe.
“This is a difficult decision. I think it’s going to be contentious no matter how it falls out,” said Dr. Howard Fillit, chief science officer of the Alzheimer’s Drug Discovery Foundation, who consults for Biogen.
ABOUT THE DRUG
Aducanumab (pronounced “add-yoo-CAN-yoo-mab”) aims to help clear harmful clumps of a protein called beta-amyloid from the brain. Other experimental drugs have done that but it made no difference in patients’ ability to think, care for themselves or live independently.
It’s a biotech medicine made from living cells, and such drugs are very expensive. No price estimate has been announced for the drug, which is given through an IV once a month. Fillit notes that Biogen drugs for other diseases cost $3,500 a month, plus fees for each infusion.
If aducanumab is approved, it’s expected to be covered by Medicare, the government plan for seniors. The FDA and Medicare are barred from considering cost when reviewing a new drug or treatment.
Even qualifying for the drug could be expensive. It’s only been tested in people with mild dementia from Alzheimer’s or a less severe condition called mild cognitive impairment. To verify a diagnosis has required brain scans that cost $5,000 or more. Insurers including Medicare don’t cover the scans because their benefits are unclear, but that could change if a scan becomes a gateway to treatment.
Historically, the FDA often required two studies showing safety and effectiveness, but in recent years has relaxed that standard.
Each of the two aducanumab studies enrolled about 1,650 people and were stopped roughly halfway through when it seemed the drug wasn’t working. Biogen says that later results show one study was positive at the highest dose; the second study was clearly negative. The company says an analysis from both studies on people who got the highest dose for the longest time shows benefit.
But there are many questions about the validity of such analyses. Another complication: the studies were changed after they were underway to let some people get a higher dose. And the placebo group in the positive study worsened more than the one in the negative study did, which could help explain why aducanumab appeared better by comparison in that one.
The FDA review largely dismissed safety concerns, including swelling in the brain that occurred in as many as one-third of patients, often leading to discontinuation of the drug.
The FDA should require a third study to test the drug in ideal conditions and get a clear answer, said the Mayo Clinic’s Dr. David Knopman. He’s on the FDA advisory panel but won’t vote on aducanumab because he helped lead one study. He and other doctors published a journal report earlier this week arguing against approval.
WHAT IT WOULD MEAN FOR PATIENTS
Any benefit from the drug “is relatively small,” said Dr. Eliezer Masliah, neuroscience chief at the U.S. National Institute on Aging.
In the positive study, the drug modestly slowed the rate of mental decline -- a difference of only 0.39 on an 18-point score of thinking skills. How much that means in terms of being able to live independently, recognize family members or remember things is unclear.
Drugs that remove amyloid may have to be combined with medicines that do other things in the brain, and used early enough before damage occurs, to do much good, Masliah said.
If the drug is approved, the American Academy of Neurology urged the FDA to not make it a broad authorization, which could expose many patients to a medicine that might harm rather than help, and could “overwhelm the health care system.”
Higher vitamin D during the first year of life can help to beat obesity in adolescence, according to a study.
The study which was posted on the website of the University of Michigan (UM) on Thursday, said low levels of vitamin D during the first year of life are inversely associated with metabolic syndrome in adolescence, reports Xinhua.
The study used data from more than 300 children from a cohort of about 1,800 participants recruited as infants. The children from 50 low- and middle-income neighborhoods in Santiago, Chile, were followed through adolescence for a cardiovascular risk assessment.
The researchers measured blood concentration of vitamin D at age 1 and examined its association with body mass index-for-age at ages 5, 10, and 16-17. They also measured the percentage of fat and muscle mass and a metabolic syndrome score and its components, say waist circumference, blood pressure, blood lipids, insulin resistance, at age 16-17.
They found that every extra unit of vitamin D in the blood of a 1-year-old was related to a slower gain in body mass index (BMI) between ages 1 and 5, a lower metabolic risk score at age 16-17 and less body fat and more muscle mass in adolescence.
Another important aspect of the study was that it was conducted at a time when early cardiovascular risk factors in Chilean children were on the rise, driven in part by the obesity epidemic in this Andean country.
"The fact that you can have 16-year-olds with high blood pressure, a poor lipid profile and insulin resistance is very sobering. Finding potentially modifiable factors that might modulate that risk could be valuable," said senior author Eduardo Villamor, professor of epidemiology at UM School of Public Health.
Metabolic syndrome is a group of conditions such as high blood sugar, excess body fat around the waist and abnormal cholesterol or triglyceride levels that together increase risk of heart disease, stroke and type 2 diabetes.
The study has been published in the American Journal of Clinical Nutrition.
Read Also: HIIT: JUST a fat killer?
Burning fat and getting gains are two requirements that come to mind when sculpting the perfect summer body. With a plethora of fitness options at our fingertips, it can be disorienting to identify the right program for you. High Intensity Interval Training (HIIT) is one that has stood out among the many for its simple, yet effective routine over recent years — and it looks like it’s here to stay. From the get go, it may seem like cardio is the winning trait keeping this regimen alive, but there are a few other benefits up its sleeve that proves HIIT is more than just a fat killer.
Cutting an extremely high number of calories in a short period of time sounds like a good gig, and has always been a huge factor of HIIT’s immense popularity within the industry. As its name suggests, HIITS is all about giving your body a high-impact interval work out with very short periods of rest. An example would be to commit to a minute non-stop push-ups. After the minute, take 15 seconds of rest before moving on to the next set. Sets are highly dependent on the individual, ranging from three to even a dozen.
From the get go, one of its biggest appeals is its accessibility when you’re tight for time. HIIT is a system you can easily incorporate to many other anaerobic workouts. Climbing stairs, burpees, lunges and other exercises are easily done without the need for fancy gyms or expensive equipment. Its accessibility also holds true because of its non-existent barrier of entry: with nothing but a few exercises in mind, beginners can incorporate intensive intervals without the training needed for more advanced anaerobic activities like swimming and running.
Despite the consensus of being a program of weight loss, HIIT’s ability to be used in various activities also prevent muscle mass from taking a huge hit.
Having a little bit of muscles is a common goal for many, but when cardio is in play, there is always the worry of losing the results after months of hard work at the gym. Burst workouts, especially static exercises cause muscle hypotrophy due to concentrated spurts of activity, much like weightlifting. Although it doesn’t compare to the growth you see at the gym, its highly intensive properties prevent your muscle fibers from leaning out.
Whether it’s something simple like stair-climbing or the traditional burpees, giving yourself bursts of exertion will bring your body to a state called “Excess Post-Exercise Oxygen Consumption (EPOC). This post-exercise period is a process that happens when the body recovers from vigorous workouts, consuming a higher amount of oxygen that ultimately requires more energy output. Furthermore, intensive intervals require more energy for recovery, burning 15% more calories than many other cardio workouts. Not only does this boost your metabolism overtime, but spending more energy ties in well with muscle stimulation and effective circulation.
So let’s recap: you don’t need a lot of time, you aren’t restricted to a particular atmosphere for a good workout, you melt calories effectively and get to avoid drastic muscle loss while doing it. HIITS can seem like much for the unprepared, but by setting realistic targets every session and enough practice, your hard work WILL pay off.
If one arm temporarily immobilized due to injury, people still can increase the muscle strength and reduce muscle loss without touching it by doing exercise in the opposite one, Australian researchers reported on Thursday.
The study conducted by researchers from Edith Cowan University (ECU) in Australia and their international colleagues could lead to a new way of rehabilitation and improve outcomes for post-injury and stroke patients.
During the study, researchers made experiments on 30 participants who had one arm immobilized for a minimum of 8 hours a day for four weeks.
Some of them were instructed to do a mix of eccentric and concentric exercises, some with eccentric exercise only and the rest of them had no excise at all.
In eccentric exercises, the contracting muscle is lengthening, such as when lowering a dumbbell in bicep curls, sitting on a chair slowly or walking downstairs. While in concentric exercises, muscles are shortening such as when lifting a dumbbell or walking upstairs.
A researcher, Prof. Ken Nosaka from ECU's School of Medical and Health Sciences said the group that only performed the eccentric exercise on their active arm showed an increase in strength and a decrease in muscle wastage, in their immobilized arm.
"Participants who did eccentric exercise had the biggest increase in strength in both arms, so it has a very powerful cross-transfer effect," Nosaka said.
"I think this could change the way we approach rehabilitation for people who have temporarily lost the use of one arm or one leg," he added.
"By starting rehab and exercise in the uninjured limb right away, we can prevent muscle damage induced by exercise in the other limb and also build strength without moving it at all," he noted.
Nosaka said he is hopeful their findings could also help a wider range of people with immobility problems due to injury or sickness.
"In the future, we hope to look at how eccentric exercise can help improve motor function, movement and fine muscle control, which is particularly important for stroke and rehabilitation patients," he said.
READ ALSO: Health risks of prolonged sitting
The British government's science advisers have warned that reinfections with COVID-19 are "to be expected" as the virus continues to spread in the country.
The conclusion by researchers on the COVID-19 Genomics UK Consortium is based on what is known about people's immunity to other coronaviruses that cause the common cold, according to a report by The Guardian newspaper on Saturday.
It was unclear how soon people who had recovered from COVID-19 could become vulnerable to reinfection, but emerging reports showed the timeframe was "relatively short", said the report.
Currently, there are seven types of coronavirus that infect humans. Among them, Sars, Mers and Sars-Cov-2, the virus that causes COVID-19 are considered the deadliest. The four others cause common colds and can reinfect people six months after they have recovered from the same virus, according to the report.
Nearly two dozen cases of suspected or confirmed COVID-19 reinfections emerged across the globe, but the real number is thought to be far higher, since most reinfections are not recorded, said the report.
Another 16,171 people in Britain have tested positive for COVID-19, bringing the total number of coronavirus cases in the country to 705,428, according to official figures released Saturday.
The coronavirus-related deaths in Britain rose by 150 to 43,579, the data showed.
Britain's coronavirus reproduction number, also known as the R number, has edged up slightly, the latest government figures showed Friday.
The government's Scientific Advisory Group for Emergencies (SAGE) said the R number is now between 1.3 and 1.5, up from last week which was between 1.2 and 1.5. If the R number is above one, it means the number of cases will increase exponentially.
To bring life back to normal, countries, such as Britain, China, Russia and the United States are racing against time to develop coronavirus vaccines.