FDA advisor resigns after agency approves new treatment for Alzheimer's - Godz
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FDA advisor resigns after agency approves new treatment for Alzheimer’s



Two members of a U.S. Food and Drug Administration (FDA) advisory committee have resigned in the wake of the agency’s approval of aducanumab, the first new Alzheimer’s treatment since 2003.

Neurologists David Knopman, who works for the Mayo Clinic, and Joel Perlmutter, of Washington University St Louis, both stepped down from the board this week in protest. 

Knopman and Perlmutter largely objected to the approval of the drug citing its rocky trial results with little evidence the drug was even effective.

The drug, which will be marketed under the name Aduhelm is being sent out to patients in the next two weeks and will cost $56,000 per year of use. 

Dr David Knopman (pictured) resigned from an FDA advisory committee after the agency gave a controversial approval to aducanumab after clinical trials showed limited effectiveness of the drug

The FDA’s approval of aducanumab adds a new drug to the arsenal of fighting Alzheimer’s for the first time since 2003. Many in the Alzheimer’s community support the drugs approval

‘The whole saga of the approval of aducanumab…made a mockery of the [advisory] committee’s consultative process,’ Knopman told the committee in an email obtained by the Washington Post.

‘While I realize that the committee is advisory, the approval of aducanumab appears [to] have been foreordained.’

Meanwhile, Perlmutter told STAT News that he quit ‘due to this ruling by the FDA without further discussion with our advisory committee.’

Biogen, the Cambridge, Massachusetts-based company that developed the drug, underwent two clinical trials in 2016. 

Both were stopped early as they showed the drug would fail to reach its goal.

They later took the results of one of the two trials, and found updated data that the drug had slowed the cognitive decline of Alzheimer’s patients by up to 22 percent.

Many in the scientific community criticized Biogen’s claims, saying it was a post-hoc cherry-picking of data to force a conclusion.

Knopman authored a study last year, analyzing the results of Biogen’s second clinical trial, disagreeing with the claims that they showed the drug was effective.

‘We identified alternative accounts for the apparent drug benefits in post hoc subgroups that are unrelated to dose effects,’ he wrote.

‘Biomarker data were consistent with target engagement, but no evidence was presented to correlate biomarker changes to cognitive benefits.

‘Aducanumab’s efficacy as a treatment for the cognitive dysfunction in Alzheimer’s disease cannot be proven by clinical trials with divergent outcomes.

‘Based on our review of data presented publicly in December 2019, we do not agree with Biogen’s claim for efficacy of [aducanumab].’  

Dr Knopman has been one of aducanumab, saying that Biogen’s trials of the drug do not show that the drug is effective in combatting Alzheimer’s

Knopman served as a site investigator for the drug, and had to recuse himself from the November advisory meeting. 

While the FDA is not required the follow advice from the advisory boards, since they are made up of third parties, it is rare that members of an advisory board are more conservative on a drug than the regulatory agency.

‘I recognize that the role is advisory and yet I felt that the advisory committee in this situation was not well-treated,’ Knopman told The Post.

 ‘And I think that I just don’t choose to put myself into that position in the future for the FDA.’ 

The drug’s approval was based on its ability to reduce amyloid beta, a plaque many believes contributes to the cognitive decline in Alzheimer’s, in the brain. 

Dr Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said the agency was aware of the controversy in approving the drug in a statement Monday.

‘We are well-aware of the attention surrounding this approval,’ she wrote.

‘We understand that Aduhelm has garnered the attention of the press, the Alzheimer’s patient community, our elected officials, and other interested stakeholders.’

‘With a treatment for a serious, life-threatening disease in the balance, it makes sense that so many people were following the outcome of this review.’

While some scientists and researchers oppose the drug, many in the Alzheimer’s community support its approval, as the first new treatment for the disease in 20 years could create a foothold for future research. 

Aduhelm will start shipping out in two weeks to over 900 infusion centers across the country that are currently equipped to implement it. 

This post first appeared on Daily mail

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US government purchases 200 million additional COVID-19 vaccines from Moderna 




The U.S. government has purchased 200 million additional doses of Moderna‘s COVID-19 vaccine.

With the 300 million doses already purchased from the biotechnology company, that brings America’s total order up to 500 million.

Under the terms of agreement, Moderna will deliver 110 million doses by the end of 2021 and 90 million in the first quarter of 2022.

What’s more, the Biden administration will also have the option to purchase any future coronavirus immunizations that Moderna is working on.

‘We appreciate the collaboration with the U.S government for these additional doses of the Moderna COVID-19 vaccine, which could be used for primary vaccination, including of children, or possibly as a booster if that becomes necessary to continue to defeat the pandemic,’ said Moderna CEO Stéphane Bancel in a statement.

‘We remain focused on being proactive as the virus evolves by leveraging the flexibility of our mRNA platform to stay ahead of emerging variants.’   

It comes as the rate of vaccinations in the U.S. has slowed significantly to an average of 1.1 million shots per day, down from an average of 3.3 million in early April – making it highly unlikely the U.S. will meet President Joe Biden’s goal of vaccinating 70 percent of all U.S. adults by July 4.

The U.S. government has purchased an 200 more million doses of Moderna’s COVID-19 vaccine, bringing the total order to 500 million. Pictured: A healthcare worker holds a vial of the Moderna COVID-19 Vaccine at a pop-up vaccination site in New York City, January 29

It is not exactly clear what the future doses will be used for but there are a few theories.

One is that the shots sitting in the U.S. stockpile may have expiration dates that are approaching and the new doses will replace those.

Another is that, because scientists believe COVID-19 is going to become an endemic disease – meaning it is always circulating at low rates – all future generations will have to be vaccinated against it, and the doses are in preparation for when the vaccine is authorized in kids.

A third option could be that the doses are used as part of Biden’s plan to deliver at least 80 million shots for about 100 countries.

The new doses will not be used as boosters, which Moderna is currently testing in clinical trials with the National Institutes of Health.

The company has developed two different types of boosters,  one with a new formula called mRNA-1273.351, and another called mRNA-1273.211, which combines Moderna’s original vaccine and the booster shot in one dose.

Two-thirds of participants different doses of mRNA-1273.351 and the remaining third will get the combination booster. 

Less than one week ago, Moderna asked the U.S. Food and Drug Administration (FDA) to expand emergency use of its COVID-19 vaccine to Americans between ages 12 and 17.

When the vaccine was originally authorized for use by the FDA in December 2020, it was only for those aged 18 and older. 

However, recent Phase III clinical trial data showed no children who were given the immunization fell ill with the virus within 14 days of their second dose, while four children given the placebo later tested positive.

According to Moderna, this is ‘consistent with a vaccine efficacy of 100 percent.’ 

This post first appeared on Daily mail

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Truck drivers with poor nutrition are more likely to have fatigue and be dangerous drivers




Having a poor diet may increase the risk of dangerous driving for truck drivers, a new study suggests. 

A Beijing-based team of researchers looked at the diets of nearly 400 male truck drivers in Suzhou, China – a city west of Shanghai in the Jiangsu province.

They determined that drivers who ate more more junk food, snacks and animal proteins were more likely to be fatigued and drive dangerously, which could lead to car crashes.

Conversely, truck operators who ate vegetable-rich diets were more likely to be safer and more alert on the road.

Truckers with poor diets are more likely to be fatigued, make errors and be aggressive drivers. A study in Germany found that many truckers eat poor diets as they eat a large portion of their food at truck stops, where there are not as many healthy options

Most of the drivers were between the ages of 31 and 60, with between six to 10 years experience as a driver, and between 31,000 to 62,000 miles (50,000 and 100,000 kilometers) on the road in an average year.

Each of the drivers in the study, which is available Tuesday in the Occupational & Environmental Medicine journal, was given a survey, asking how often they ate each of 25 different types of food over the past 12 months.

Drivers were placed into categories according to their reported diets: vegetable rich, staple foods (like eggs, milk and other common items), animal proteins and snack foods. 

They also completed Multidimensional Fatigue Inventory surveys, which judge physical and mental fatigue, and they were surveyed on their behaviors and attitudes while on the road.

Those who ate vegetable rich or staple food diets were found to have less fatigue and be safer drivers.

They were more attentive, made fewer errors while driving and were less aggressive with their driving. 

Meanwhile, drivers with animal protein-based diets and those who were on snack food diets were more likely to be unsafe drivers.

All truckers in these two groups were likely to make more errors and be more aggressive than their peers, with drivers on snack food diets being especially unlikely to exhibit positive driving behaviors. 

‘The results of this study support a relationship between dietary patterns and driving behavior in a sample of professional truck drivers,’ the researchers wrote.

‘Moreover, through the pathway analysis reported, it is possible to conclude that positive driving behavior can be predicted by prudent dietary patterns such as vegetable-rich diets, while some dangerous driving behaviors (errors, lapses and violations), can be predicted by unhealthy dietary patterns characterized by high intake of fats and [sugars].’

Drivers dietary pattern effects both their level of fatigue and driving behaviors, while fatigue can likely effect drivers behaviors as well

Both of the latter two categories were also associated with higher levels of fatigue. 

There have long been links between eating a healthier diet and having more energy throughout the day, and being more attentive. 

Truckers often eat at truck stops, and do not have time to cook for themselves, instead eating the food available to them at these stops. 

About 37 percent of the truckers in the study either ate all of their meals or a lot of their meals at truck stops.

Truckers who brought food from home were often eating healthier foods like fruits, vegetables and nuts rather than the meats, snack foods and sugary foods those who ate on the roads did. 

The researchers also note that there are demonstrable links between making unhealthy life choices and also living a more dangerous lifestyle, as people who eat more unhealthy food are more likely to take unneeded risks. 

Because fatigued drivers were more likely to be dangerous, and fatigued drivers were more likely to make the poorer diet choices, researchers believe the fatigue played a role in less attentive and error prone driving as well.

They can not be 100 percent certain, though, according to their report.  

This post first appeared on Daily mail

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NHS to give artificial pancreas to 1,000 diabetics to test if it prevents life-threatening attacks




A thousand diabetes patients will be given an artificial pancreas as part of a pilot scheme, the head of the NHS said yesterday.

Patients with type 1 diabetes will be able to use the devices, which continuously measure a person’s glucose levels and deliver insulin directly to the bloodstream – automatically balancing blood sugar levels.

Chief executive Sir Simon Stevens told the NHS Confederation’s conference up to 1,000 patients will benefit from a test of the innovative technology.

A thousand diabetes patients will be given an artificial pancreas as part of a pilot scheme, the head of the NHS Sir Simon Stevens (pictured) said

The devices could help eliminate finger prick diabetes tests and help prevent life-threatening hypoglycaemic attacks.

Sir Simon said the technology was just ‘one example of a whole fizz of innovation which continues across the Health Service’. 

He added: ‘Living with diabetes is a daily challenge for millions of people across England and this technology has the potential to make a remarkable difference to their lives. This innovation is a prime example of the NHS’s continued progress in modern medicine and technology.’

The devices could help eliminate finger prick diabetes tests and help prevent life-threatening hypoglycaemic attacks

Professor Partha Kar, NHS national speciality adviser for diabetes, added: ‘One hundred years after the discovery of insulin, the ‘artificial pancreas’ is a potentially revolutionary development in the treatment of diabetes.

‘The NHS has long been at the forefront of clinical advances in care for major diseases, including diabetes, which have allowed patients to live longer and healthier lives.’

Sir Simon also hailed other medical advances in the health service, from new cancer treatments to drugs for spinal muscular atrophy and cystic fibrosis.

Meanwhile, other innovations mean there is a “realistic prospect” that HIV would be eliminated in this country by 2030, he said.

And ‘ground-breaking’ deals with drug companies could mean that the nation is ‘well on track to eliminating hepatitis C, ahead of the 2030 goal set by the World Health Organisation’.

Sir Simon also praised the clinical trails which have taken place in the NHS during the pandemic.

‘The latest estimate is that as a result of those, over a million lives have been saved worldwide thanks to research done in the NHS, over the course of months not years,’ he added.

This post first appeared on Daily mail

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