Does new Alzheimer’s drug work?

When a controversial Alzheimer’s drug won U.S. approval, surprise over the decision quickly turned to shock at how long it might take to find out if it really works — nine years.

Drugmaker Biogen has until 2030 to complete a study confirming whether its new drug Aduhelm truly slows the brain-destroying disease. That’s under the terms of the Food and Drug Administration’s conditional approval of the drug, a decision that has been praised by patients as overdue and condemned by the agency’s own outside experts.

But both camps agree: 2030 is far too long to wait for answers on the $56,000-a-year drug.

“We think nine years is unacceptable and our expectation is that it will happen in a much shorter time frame,” said Maria Carrillo of the Alzheimer’s Association, an advocacy group that pushed for approval but now wants the FDA to set a quicker deadline.

Other experts warn that the 2030 timeline could slip if patients balk at enrolling in a new study for a drug that’s already available. And the focus on Aduhelm — the first new Alzheimer’s drug in 18 years — could steer volunteers away from testing of other promising treatments.

“If someone can go to their physician and get the FDA-approved drug, why would they go into a trial where they risk getting a placebo?” said Donna Wilcock, an Alzheimer’s researcher at the University of Kentucky.

To establish a new drug’s safety and effectiveness, researchers compare results in people who get the treatment to a similar group of people who don’t. That generally means half of the volunteers are randomly assigned to get a fake treatment instead of the real thing.

Biogen already conducted two such large studies of its drug, which requires monthly IVs. The studies took about four years to run and followed participants for about 1 1/2 years. Both were stopped early when it seemed the drug wasn’t working, and the results were so mired by flaws and inconsistencies that the FDA deemed them too weak to support approval on the basis of slowing the disease.

Instead, the agency took another approach and gave the drug conditional approval based on a promising sign: its success in getting rid of a buildup of sticky plaque in the brain that is thought to play a role in Alzheimer’s disease.

Under its so-called accelerated approval program, the FDA is requiring Biogen to conduct a new study definitively answering whether Aduhelm’s effect on plaque truly slows mental decline in patients. Other Alzheimer’s drugs on the market only temporarily ease symptoms.

The FDA has not detailed how the 2030 target came about, or why such a distant deadline was granted for a drug that could be given to millions of patients in the coming years, adding billions to the nation’s health care bill.

“Alzheimer’s trials take time to complete,” the FDA said in a statement responding to questions about the study. The agency added that it might be possible to answer key questions about Aduhelm before the study’s completion and that Biogen is expected to submit results “as soon as feasible.”

But the agency’s critics point out that nine years is among the longest follow-up periods the agency grants drugmakers. Drugs approved under similar circumstances typically get six years. And, if anything, those studies tend to run behind schedule, not finish early. If follow-up studies don’t have positive results, the FDA can withdraw approval, though it rarely does so.

“Just because it says nine years doesn’t mean the evidence will be available in nine years,” said Joshua Wallach, a medical researcher at Yale’s School of Public Health. “There’s all of this back and forth discussion that can happen with FDA that can delay completion.”

Biogen isn’t scheduled to submit its initial proposal for the study to FDA until October. The Massachusetts-based company said in a statement that large Alzheimer’s trials often take six or seven years and that FDA-mandated studies can take even longer.

“We are working with urgency and putting resources and plans in place,” to complete the trial ahead of schedule, the company stated.

Meanwhile, Alzheimer’s specialists like Dr. Samuel Gandy are seeing patients in other drug studies ask about dropping out so they can get Aduhelm.

“They’ve all said, ‘You know, I can’t stand the idea of being on placebo,’” said Gandy, who has heard from more than 20 families interested in the drug at New York’s Mount Sinai hospital.

After he explained the drug’s unknown benefits and potential side effects — including brain swelling and bleeding — several decided against it. But other patients remain interested.

Post-approval studies have become an increasingly common FDA requirement since the 1990s, as regulators have accelerated their reviews of drugs for HIV, cancer and other deadly diseases. But the agency’s mixed record of tracking those requirements and penalizing companies that don’t meet them has been chronicled in government and academic studies.

The case of a widely debated drug for muscular dystrophy illustrates how the system can go awry.

In 2016, the FDA approved the first-of-a-kind drug from Sarepta Therapeutics based on preliminary results that it might help treat the degenerative disease by boosting a muscle-building protein.

As with Aduhelm, the approval was opposed by FDA’s outside advisers who said there was scant evidence the drug actually improved patient health or quality of life. But the FDA granted approval on the condition that Sarepta complete a confirmatory study by May 2021.

The trial, though, is still getting underway after “multiple challenges in the overall planning and startup,” according to the FDA’s website. The new target date is 2026, a decade after the drug was allowed on the market.

A Sarepta spokeswoman said the company spent years negotiating study details with the FDA, which required testing a higher dose.

In the meantime, Sarepta has won approval for two other dystrophy drugs based on similar results that also require follow-up trials, which the company says are already well underway.

“The FDA took a risk with Sarepta and I think they’re being burned by it now,” said Dr. Joseph Ross of Yale.

Ross and his colleagues have shown that at least a quarter of follow-up results never get published, leaving questions for physicians and patients.

The results from Biogen’s two Aduhelm studies have yet to appear in a medical journal. The company says it is “working diligently to publish our data.”

CDC says U.S. young adults less likely to take COVID-19 vaccine

June 21 (Reuters) – Younger adults are seeking out COVID-19 vaccines at a slower rate than older adults, and if that pace of vaccination continues through August, vaccine coverage among younger adults will not reach levels achieved with older adults, U.S. Centers for Disease Control and Prevention (CDC) reported on Monday.

The agency said more work is needed to increase vaccination rates among younger adults to reduce COVID-19 hospitalizations and deaths.

Of the 57% American adults who received at least one vaccine dose by May 22, coverage was highest among people 65 or older and lowest among people aged 18 to 29, according to an analysis of vaccine rates published on Monday in the CDC’s Morbidity and Mortality Weekly Report.

The observations are based on vaccination data reported to the agency from Dec. 14, 2020 to May 22, 2021.

Younger Americans also are more likely to be reluctant to get vaccinated because of concerns over vaccine safety and effectiveness, the agency reported separately on Monday, citing data from household surveys conducted from March to May, 2021.

Benefits From consuming Garlic

Before we go deep into the benefits of garlic, let’s educate ourselves on the knowledge available about the nature of garlic.

Garlic is genus, Allium; a specie of onion. Its close relatives include the onion, shallot, leek, chive, and Chinese onion.

It is common with Central Asia and northeastern Iran, and has been a seasoning agent on our diets.

Now, let’s look at few benefits of garlic in our everyday food consumption.

Allicin compound exists in freshly cut or crushed garlic.

Other food compounds that play role in the health benefits of garlic includes diallyl disulfide and s-allyl cysteine.

Trully, if you want the full benefits of garlic. You should eat it raw.

Garlic boosts the immune system. Garlic boots the immune system of the body. Cold and common flu is one the fewer diseases that helps us to check our immune system. If we include garlic in our diets, common flu and cold will not be our problem.

Garlic reduces blood pressure. Garlic in certain amount of dose can drastically reduce high blood pressure .

Garlic reduces bad cholesterol levels. Garlic helps in reducing Low-density lipoprotein (LDL) cholesterol and balancing High-density lipoprotein (HDL).

Garlic improves the function of the brain. Garlic contains antioxidants which counters free radicals causing oxidation and serving as aging factor. And we all know some of the health problems associated with aging includes Dementia and Alzheimer’s.

An avocado a day could lower ‘bad’ cholesterol levels,

We’ve all heard the old saying, “An apple a day keeps the doctor away.” According to a new study, however, the same may be true for avocados — at least when it comes to lowering “bad” cholesterol levels.

The study, conducted by researchers at Penn State University and published in the Journal of Nutrition, suggests that eating one avocado a day can lower levels of low-density lipoprotein (LDL), the type of cholesterol considered to be “bad.” High levels of LDL can build up within blood vessel walls, sometimes causing a stroke or heart attack, per the Mayo Clinic.

On the other hand, high-density lipoprotein, or HDL, is often regarded as “good” cholesterol.

For the study, researchers recruited 45 adults who were either overweight or obese. For the first two weeks, participants ate a diet that “mimicked an average American diet,” which allowed all those involved to “begin the study on similar nutritional ‘footing,’” according to a news release regarding the study. 

Later, the participants were separated at random into three groups. Each group either followed a low-fat diet, a moderate-fat diet, or a moderate-fat diet that also involved eating an avocado each day.

Five weeks later, those who ate an avocado each day “had significantly lower levels of oxidized LDL cholesterol than before the study began or after completing the low- and moderate-fat diets,” per the news release. “Participants also had higher levels of lutein, an antioxidant, after the avocado diet.”

In other words, the researchers determined that avocados may be able to lower oxidized LDL particles. Oxidation can negatively affect the human body.

“When you think about bad cholesterol, it comes packaged in LDL particles, which vary in size. All LDL is bad, but small, dense LDL is particularly bad. A key finding was that people on the avocado diet had fewer oxidized LDL particles. They also had more lutein, which may be the bioactive that’s protecting the LDL from being oxidized,” said Penny Kris-Etherton, distinguished professor of nutrition, in a statement.

“A lot of research points to oxidation being the basis for conditions like cancer and heart disease,” Kris-Etherton added. “We know that when LDL particles become oxidized, that starts a chain reaction that can promote atherosclerosis, which is the build-up of plaque in the artery wall. Oxidation is not good, so if you can help protect the body through the foods that you eat, that could be very beneficial.”

That said, Kris-Etherton did note that more research is needed to understand the more nuanced health benefits of avocados, which are already known to be full of important nutrients – such as vitamin K and potassium – as well as fiber, heart-healthy fatty acids and antioxidants.

Spring, the most inspiring of the seasons (this year especially)

(CNN)As the end of the pandemic tunnel gets brighter and brighter, has a season ever better aligned with where most people are in the world right now?Spring is the season of hope — that things will get better after they were worse. The river will “flow again after it was frozen,” Ernest Hemingway wrote of spring in “A Moveable Feast.” Change is a-comin’, and everything is going to be better for it.”If we had no winter, the spring would not be so pleasant,” wrote English poet Anne Bradstreet. “If we did not sometimes taste of adversity, prosperity would not be so welcome.”Spring is arguably the most profound of the seasons in terms of its meaning, promise, inspiration and experiences. It is the season of new starts and ideas bursting from the ground like the return of grass, daffodils and cherry blossoms.

Snake venom is a boon in search for life-saving drugs

(CNN)Over the summer, Chicago-based cardiologist Dr. Sandeep Nathan received a phone call that a patient was in trouble.Every minute that went by put the patient more atrisk. In his mid-30s, he was suffering from a massive heart attack with excessive blood clotting in the vessels around his heart. He had also tested positive for Covid-19.Several studies have shown that coronavirus impacts more than just the lungs and respiratory system — including the heart. “There is an acute inflammatory response, increased blood clotting and cardiac involvement,” cardiologist Dr. Nieca Goldberg, medical director of New York University’s Women’s Heart Program, previously told CNN Health. Goldberg is also a senior adviser for women’s health strategy at NYU Langone Health.

Before beginning a procedure to clear the vessels and put in stents, Nathan and his team administered blood thinners, including Integrilin, to help break up the clots.

The US Food and Drug Administration first approved Integrilin in 1998, and medical professionals commonly prescribe it to heart attack patients. But what manypeople don’t realize is the drug was originally derived from a protein found in the venom of the pygmy rattlesnake.

“Several hundred thousand heart attacks occur in the United States every year, and a significant proportion of these heart attacks are treated with agents, which unbeknownst to both the physician and patient, are actually derived from animal venom,” said Nathan, director ofthe University of Chicago Medicine’s Coronary Care Unit and co-director of its Cardiac Catheterization Lab.”There’s a bit of a misconception that drug development, particularly with antiplatelets or anticoagulants, is now passé — that we’ve discovered everything that we need to know,” he added. “In my opinion, nothing could be further from the truth.”http://Snake venom is a boon in search for life-saving drugs

COVID-19 vaccines are safe and effective in pregnancy, new study shows

The Moderna and Pfizer COVID-19 vaccines trigger strong immune responses in pregnant and breastfeeding women, equivalent to that of other women of reproductive age, preliminary research shows. 

The data also suggests that the vaccines are equally safe in all women of reproductive age, and that they likely offer at least some protection to fetuses through the placenta, and to newborns through breast milk.

That said, the study, posted March 8 to the preprint database medRxiv, has not been peer-reviewed and included a relatively small group of participants; a total of 131 vaccinated women participated in the study, including 84 pregnant, 31 breastfeeding and 16 non-pregnant women. For comparison, the study authors also analyzed banked blood samples from 37 women infected with COVID-19 during pregnancy.

“This is preliminary evidence … but from the results that are presented, vaccines work well in pregnant and lactating women, and similar to non-pregnant persons, and better than natural immunity [immunity gained from catching the virus itself]”, said Dr. Denise Jamieson, the chair of the Department of Gynecology and Obstetrics at Emory University School of Medicine, who was not involved in the study. 

These results align with data presented in other preliminary studies, as well as a recent report by the Centers for Disease Control and Prevention (CDC), which is monitoring for vaccine-related side effects through its v-safe smartphone app and has a specific registry for pregnant people, Jamieson added.

Scientists suspected that COVID-19 vaccines would be safe and effective in pregnant and breastfeeding people, but they lacked hard data because these demographics were excluded from vaccine trials, Live Science previously reported. The new study is an important “first step” to confirming the positive results that scientists anticipated, said Dr. Stephanie Gaw, an assistant professor of obstetrics, gynecology and reproductive sciences at the University of California, San Francisco, who was not involved in the study.

Good news so far

The new research only considered the Moderna and Pfizer vaccines because those were the only COVID-19 shots authorized for emergency use at the time of the study. Both vaccines contain mRNA, a type of genetic material that encodes instructions for cells to build proteins. 

Once inside the body, the mRNA instructs cells to build spike proteins, a structure that sticks out of the coronavirus. The immune system learns to recognize the spike and destroy the attached virus. The mRNA then quickly degrades, remaining in the body for a few days, at most, according to Horizon, the European Commission’s research magazine.

Not all the COVID-19 vaccines use mRNA; for instance, the Johnson & Johnson shot contains a modified common cold virus. Future studies will need to assess non-mRNA vaccines in pregnant people, but for now, the new study offers tentative “good news” for the Moderna and Pfizer shots, Jamieson said.

The study participants provided blood samples at the time of their first and second vaccine doses, and then again two to six weeks after their second dose. Those who gave birth during the study also provided a sample at the time of delivery. The researchers screened these blood samples for SARS-CoV-2 antibodies, molecules that bind to the coronavirus and mark it for destruction. 

“Strikingly higher levels of SARS-CoV-2 antibodies were observed in all vaccinated women compared to pregnant women with natural infection,” the study authors wrote.

Of the pregnant participants, 13 gave birth during the study period, and the study authors were able to analyze umbilical cord blood from 10 of them. All 10 umbilical cord samples contained vaccine-generated antibodies, suggesting that immune protection against SARS-CoV-2 had passed from the mothers to their infants. 

All the breast milk samples collected after vaccination also tested positive for antibodies. After the second shot, a type of antibody called immunoglobulin G, or IgG, significantly increased within the milk. At this point, it’s unknown how much protection these antibodies offer newborns or how long that protection will last, but this study sets a starting point for investigation, Gaw said. 

All women in the study experienced similar types of side effects, such as headache, soreness and rashes at the injection site. They also experienced these side effects at similar rates, regardless of whether they were pregnant, breastfeeding or neither. 

A subset of women in each group experienced fever and chills, most commonly after their second vaccine dose. This included about one-third of the pregnant group, highlighting that those who receive the vaccines in pregnancy should monitor for this side effect, the study authors noted.

Fevers — particularly long-lived, high-grade fevers — have been associated with a heightened risk of miscarriage and certain birth defects, Gaw said. High-grade fevers in the first trimester pose the most significant risk, but “a low-grade fever is probably of little consequence, especially a short-lived one,” she said.

If vaccinated pregnant women do develop a fever, “it’s important to get the temperature down with acetaminophen,” Jamieson said. She said she recommends that patients only take the drug once they feel a fever coming on, rather than taking acetaminophen before getting vaccinated. And “it’s important to remember that COVID can cause prolonged fever,” so not getting vaccinated carries its own risk, she said.

Remaining questions 

While the new study suggests that the vaccines work well in pregnant women and breastfeeding moms, the researchers did not explore potential risks to the fetus, the study authors wrote. 

Theoretically, it would be concerning if mRNA from the vaccine reached the placenta and caused inflammation of the tissue, Gaw said. Alternatively, the mRNA could also spark an immune reaction in the fetus if it crossed the placenta, she said. Because the mRNA degrades so quickly, though, it’s unlikely that any meaningful amount reaches the placenta, Live Science previously reported. In any case, Gaw and her colleagues plan to study inflammation in vaccinated mothers and babies after birth to address this potential risk.

There’s also a question of whether mRNA could pass through the breast milk. Gaw and her colleagues conducted a small study of six vaccinated individuals and found no mRNA in their breast milk; the study, posted March 8 to medRxiv, has not been peer-reviewed, but hints that this shouldn’t be a problem. 

Looking ahead, scientists also need to determine whether pregnancy outcomes are similar between vaccinated and unvaccinated women,  Jamieson said.

“The CDC is rapidly gathering that information through v-safe,” she noted. As of mid-March, more than 30,000 pregnant women had received either the Moderna or Pfizer vaccine and had registered with v-safe, according to Medscape Medical News. Of those, 275 have since completed their pregnancies, and within that group, the rate of complications, such as miscarraige, still birth and preeclampsia, was no higher than what’s seen in the general population.

“It was all very reassuring, but we need more information,” Jamieson said.

In general, research suggests that pregnancy may increase the risk of severe COVID-19, ICU admission, need for ventilation and death from the virus, according to the American College of Obstetricians and Gynecologists (ACOG). Given what we know so far, pregnant women at high risk of exposure to the virus should seriously consider the vaccine, Gaw said. 

This would include health care workers, in particular, as well as other essential workers and teachers, she said. But if a pregnant person is able to minimize their risk of COVID-19 exposure through physical distancing, they could opt to wait to get the vaccine after more data comes out, she said. Future studies could also hint at which stage of pregnancy would be best for vaccination, especially in terms of maximizing protection for the newborn, she added.  

AstraZeneca COVID-19 vaccine ‘safe and effective’ amid blood clotting reports, EU regulator says

A safety committee with Europe’s regulator concluded AstraZeneca’s COVID-19 vaccine is safe and effective, with no ties to an overall increased risk of blood clots in vaccinated individuals. However, a definitive link to serious blood disorders could not be ruled out.

Top officials with the European Medicines Agency said the benefits of the vaccine against COVID-19 and its associated hospitalizations and deaths continue to exceed the risks of side effects.

“PRAC [the safety committee] noted the number of thromboembolic events reported after vaccination [469 reports] is lower than the expected in the general population and PRAC has concluded that there is no increase in the overall risk of blood clots with this vaccine,” said Dr. Sabine Straus, chair of the safety committee.

Straus noted the vaccine is effective against COVID-19 disease, and likely reduces the risks of blood clotting events overall. However, insufficient evidence prevented the committee from concluding that serious adverse events were not vaccine-related.

As of Wednesday evening, the committee noted “very rare” case reports of serious blood disorders, including seven causes of clotting in multiple blood vessels within seven to 14 days post-vaccination, and 18 reports of clots in vessels draining blood from the brain. The serious case reports come amid a backdrop of nearly 20 million vaccinations across Europe.

The EMA said the safety committee will continue to run investigations to assess reports. The agency stressed awareness of the risks for both patients and providers, and advised including the risks in the vaccine’s product information.

Emer Cooke, executive director of the EMA, stopped short of weighing in on some member states’ paused AstraZeneca vaccine campaigns. Rather, the regulator’s “responsibility,” Cooke noted, “is to come to a conclusion as to whether or not the benefits outweigh the risks of the vaccines so that countries can make an informed decision and increase trust in the vaccine.”

Germany, France, Italy and Spain joined the growing list of mostly European countries — starting with Denmark last week — that temporarily halted the use of the AstraZeneca vaccine in recent days to investigate cases of blood clots that occurred after vaccination. Others include Thailand and Congo.

Biden: All U.S. adults to be eligible for vaccines by May, some normalcy coming by summer

WASHINGTON (Reuters) – President Joe Biden told U.S. states on Thursday to make all adults eligible for a coronavirus vaccine by May 1 and urged Americans to stay vigilant or face more restrictions, hours after he signed a $1.9 trillion stimulus bill into law.

In a forceful but somber speech from the White House on the first anniversary of the pandemic lockdown, Biden said if Americans pulled together there could be a greater sense of normalcy – and some backyard barbecue parties with small groups – on the U.S. Independence Day holiday on July 4.

That date is a new goal for the president and a projection of hope amid a pandemic that has killed more than 530,000 people in the United States, the most of any country.

To achieve his summer target, Biden said he needed Americans’ help.

“If we don’t stay vigilant and the conditions change, then we may have to reinstate restrictions to get back on track,” he said in an evening address from the White House, his first in television prime time since becoming president.

“We’ve made so much progress. This is not the time to let up. Just as we are emerging from a dark winter into a hopeful spring and summer is not the time to not stick with the rules,” he said.

South African coronavirus variant detected in New York resident

New York has confirmed a case of the South African coronavirus variant in a Nassau County resident.

The case was discovered through sequencing at a city-based commercial lab, and no other details were given in an announcement posted Sunday, such as the patient’s condition, travel history or when the case was confirmed.

Gov. Andrew Cuomo noted a drop in statewide positivity and hospitalizations, allowing a further push on reopenings, but amid news of the variant, urged residents to double down on mitigation measures like face masks, hand hygiene and social distancing.

“…With the discovery of a case of the South African variant in the state, it’s more important than ever for New Yorkers to stay vigilant, wear masks, wash hands and stay socially distanced.” Cuomo said, in part, in a statement posted Sunday. “We are in a race right now — between our ability to vaccinate and these variants which are actively trying to proliferate — and we will only win that race if we stay smart and disciplined.”

The news follows a separate announcement from last Monday, when the state confirmed the variant in a patient who was transferred to a city hospital from Connecticut. At the time, Cuomo said that there was no evidence of further spread pertaining to the case.

Several mutated versions of the virus have caused significant concern among experts because they have shown to diminish vaccine efficacy, including variants first identified in South Africa, B.1.351, and the United Kingdom, B.1.1.7. These strains involve changes along the surface spike proteins that allow the pathogen to bind more tightly to healthy cells. 

Data from the Centers for Disease Control and Prevention notes the B.1.351 variant has been reported in 22 cases across ten states, with 44 states reporting over 1,660 cases of the B.1.1.7 strain, which has been projected to become the dominant strain in the U.S. by March.

Several companies are exploring variant booster shots in a bid for more protection against the strains. Both Pfizer and Moderna have said protection against the B.1.351 variant in particular remains unclear. Studies have suggested the variant dropped the Pfizer vaccine’s neutralization power by about two-thirds, while Moderna saw a six-fold reduction in neutralizing antibodies.