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Alexa to add voices of your deceased loved ones

SAN FRANCISCO (KRON) — Amazon announced a new feature Wednesday that will allow Alexa to speak in the voices of deceased relatives, friends and other loved ones.

Speaking at the day two keynote during the company’s annual MARS conference in Las Vegas, Alexa head scientist Rohit Prasad showed a video of Alexa, ostensibly sounding like a boy’s deceased grandmother reading him a book.

“Alexa, can grandma finish reading me ‘The Wizard of Oz’?” the child asks before Alexa goes into the book.

Prasad said one thing that surprises him about Alexa is “the companionship relationship we have with it.”

“In this companionship rule, human attributes like empathy and affect are key to building trust,” Prasad said.

“These attributes have become even more important in these times of the ongoing pandemic, when so many of us have lost someone we love. While AI can’t eliminate that pain of loss, it can definitely make those memories last.”

Prasad said the voice will enable “lasting personal relationships.”

Prasad said his team “had to learn how to produce a high-quality voice with less than a minute of recording versus an hour of recording in the studio.”

Source: TEST FEED1

Expediency v efficacy: Reexamining the FDA’s accelerated drug approval process

It was precisely 30 years ago, in 1992, that the Food and Drug Administration (FDA) established the Accelerated Approval Program (AAP) in response to the HIV epidemic.

The AAP is a mechanism that permits conditional approval of a new drug that treats a serious medical condition and fills an unmet need based on its impact on a surrogate end point.  

A surrogate end point, i.e., a biomarker, may be a laboratory measure, a radiographic image, a physical sign or any measure that is presumed to predict clinical benefit but is not independently a measure of clinical improvement. To qualify, the end point must be considered likely to correlate with clinical improvement. If approved under this mechanism, the drug will need to be tested in larger, more definitive clinical trials, so-called phase 4 trials, using end points that demonstrate benefit within a few years. If these trials are inconclusive, the approval may be withdrawn. 

Today, the FDA approves more drugs through this and other related fast-track mechanisms than the traditional route. Approximately 75 percent of the drugs currently greenlighted by the FDA participated in at least one special program designed to speed up the review process. 

The AAP has had a positive impact on HIV and cancer chemotherapy, and it is estimated that more than 300 drugs have been approved through this pathway. The point of concern is that the surrogate end point, the scientific basis of the approval, does not always predict clinical utility. In the case of HIV, CD 4 counts – white blood cells that fight infection – and HIV viral load serve as reliable predictors of clinical response. In the cancer space, the ability of end points to predict clinical utility has been mixed with reports indicating that only one-fifth of drugs approved based on surrogate end points improve survival rates in confirmatory trials.  

Post approval confirmatory monitoring has been inconsistent. These drugs, at times, stay on the market despite failure to convincingly demonstrate efficacy in phase 4 trials as “dangling approvals,” drugs for which prior authorization continues in spite of lack of clinical efficacy. In the interim, they cost the public billions of dollars and raise unrealistic expectations for treatment.  

Further, all biomarkers are not the same. As we move from infectious diseases and cancer to the realm of degenerative brain disorders, the relationship of biomarkers to clinical response becomes increasingly murky. The recent debacle surrounding the approval of Aduhelm for the treatment of Alzheimer’s disease under this mechanism is a good example of the slippery slope in biomarker science resulting in premature approval. In this case, the “original sin” was the approval based exclusively on the drug’s ability to lower levels of amyloid, a putative biomarker of the disease, in the brain despite the fact that substantially lowering amyloid levels did not correlate with clinical improvement.  

Fortunately, the Centers for Medicare & Medicaid Services (CMS), after looking at the data more objectively, approved coverage only for patients enrolled in federally approved clinical trials. In this instance, society dodged a bullet and the checks and balances in our system worked. 

After spending decades developing compounds that lower amyloid levels in the brain to treat Alzheimer’s, the pharmaceutical industry is moving on to molecules and pathways other than amyloid. Biomarkers have a potentially important role to play in this regard. In the early phases of clinical trials, they can serve to identify promising drugs that are safe and target specific. Perhaps more importantly, early trials should unequivocally establish a link between biomarkers and meaningful clinical end points that can then be used in more definitive phase 3 trials that compare the drug with a placebo — the international gold standard in clinical trials. 

The AAP was established 30 years ago and was designed to accelerate drug approval in select, life threatening cases where the standard approval process was too long and cumbersome. But it was predicated on the assumption that the surrogate end point would be demonstrably linked to relevant clinical outcome measures. As the link between the surrogate marker and clinical outcomes becomes more tenuous, the process falls apart and becomes a mechanism for an end run around the regulatory pathway. Enthusiasm and expediency should not replace scientific objectivity. 

Congress is poised to give the FDA more resources to monitor late phase 4 trials after drugs receive preliminary approval under the accelerated program. That is necessary but not sufficient to correct the situation. Once a drug receives preliminary approval, close monitoring and a subsequent recall are more difficult to implement. One of the FDA’s primary responsibilities is to ensure that human and veterinary drugs, vaccines and other biological products and medical devices intended for human use are safe and effective. 

The FDA should scrutinize the accelerated program rigorously to ensure that surrogate end points are clinically meaningful before approving drugs under this mechanism. The goal of drug therapy is to treat the disease — and not surrogate markers without impacting the disease. The FDA should live up to expectations and its original mandate. 

Anand Kumar, MD, MHA is a professor and head of the department of psychiatry at the University of Illinois at Chicago and past president of the American Association for Geriatric Psychiatry. 

Source: TEST FEED1

Biden administration proposes extending Title IX protections to transgender students

The Biden administration on Thursday announced a slate of proposed changes to Title IX, including extending the protections of the law to transgender students.

The Education Department unveiled its proposals on the 50th anniversary of the landmark law, which prevents schools that get federal funding from discriminating on the basis of sex.

Under the Biden administration’s proposals, those protections would also apply to LGBTQI+ students, requiring schools to protect them from discrimination based on sexual orientation, gender identity and sex characteristics.

“As we celebrate the 50th Anniversary of this landmark law, our proposed changes will allow us to continue that progress and ensure all our nation’s students — no matter where they live, who they are, or whom they love — can learn, grow, and thrive in school,” Education Secretary Miguel Cardona said in a statement.

The Biden administration’s proposal would also alter the rules around how schools handle sexual assault and sexual harassment allegations after the Trump administration sought to make them more accommodating to the individuals being accused. Critics argued the Trump-era rules would discourage survivors from coming forward to report an assault.

The proposal would no longer require live hearings in sexual misconduct cases on college campuses, and schools would be allowed to investigate and discipline students over sexual assaults that take place off campus.

The proposal did not address protections for transgender students competing in college athletics, a point of controversy and fodder for culture wars for Republican lawmakers.

The rule-making process allows 60 days for public comment on the Biden administration’s changes. The Education Department will then finalize the changes, which could take months.

“Over the last fifty years, our nation has made monumental progress in advancing equity and equality for all students, including by narrowing gender gaps in sports, expanding opportunities in science and technology fields, and protecting students from sex discrimination, including sex-based harassment and sexual violence,” President Biden said in a statement marking the 50th anniversary of Title IX.

“Yet there is more work to do,” he added. “As we look to the next 50 years, I am committed to protecting this progress and working to achieve full equality, inclusion, and dignity for women and girls, LGBTQI+ Americans, all students, and all Americans.”

Source: TEST FEED1

Almost 6 in 10 say they are following Jan. 6 panel's work closely: poll

More than half of Americans said they are following the House select committee investigating the Jan 6, 2021, Capitol attack slew of hearings closely, according to a new Quinnipiac University poll. 

The poll, published on Thursday, found that 58 percent of respondents said they are following the committee’s hearings closely, with 26 percent following the hearings “very” closely and 32 percent following the hearings “somewhat” closely. 

Seventeen percent of respondents said in the poll that they are not following the committee’s hearings that closely and 24 percent of those surveyed said they are not following the hearings at all, according to the poll. 

Forty-six percent of those surveyed said that they believe former President Trump committed a crime on Jan 6, while 47 percent of respondents said he did not. 

Forty-one percent of respondents said that Trump bears “a lot” of responsibility for the Capitol insurrection and 18 percent of those surveyed said that Trump has “some” responsibility of the eventual outcome of the insurrection. 

Among party lines, 69 percent of Republican respondents said that Trump holds responsibility for the Capitol insurrection, while 92 percent of Democrat respondents agree with the same sentiment, according to the poll.

This comes amid a slew of public hearings being held by the Jan 6 committee investigating the Capitol insurrection in which pro-Trump supporters stormed the building in an effort to stop Congress from certifying the results of the 2020 election. The Capitol attack resulted in the deaths of five people.

Seventy-seven percent of respondents believe that extremism in the country is a bigger threat to the U.S. than extremism from other countries, while 17 percent of those surveyed said extremism from other countries is a more serious threat. 

The Quinnipiac University poll was conducted from June 17 to June 20 with a total of 1,357 respondents surveyed in the questionnaire. The poll’s margin of error was 2.7 percentage points.

Source: TEST FEED1

64 percent in new poll say they think Jan. 6 attack was planned

Nearly two-thirds of U.S. adults believe the Jan. 6, 2021 riot at the Capitol was planned, according to a new Quinnipiac poll.

The poll found that 64 percent of respondents believed the attack was planned and 30 percent believed it was spontaneous.

Democrats were more likely to believe the attack was planned — only 13 percent said it was spontaneous — while Republicans were more divided. Forty-nine percent of Republicans said the attack was planned, compared to 46 percent who said it was spontaneous.

Nearly 6 in 10 respondents believe former President Trump bears at least some responsibility for the storming of the Capitol, with 41 percent saying he bears a lot of responsibility.

But when asked if they thought Trump committed a crime in his efforts to change the 2020 presidential election results, Americans were split. Forty-six percent said he committed a crime but 47 percent said he did not.

 “Yes, the January 6 attack was planned, say more than 60 percent of Americans, and a majority say yes, former President Trump bears a measure of responsibility for the calamity that ensued,” Quinnipiac University polling analyst Tim Malloy said in a release. “But criminal charges for Trump? It’s a toss-up. There is no consensus.”

The pollsters noted that the proportion of people believing Trump committed a crime was “essentially unchanged” from when the question was asked in early April. 

But this poll came in the wake of three public hearings held by the House select committee investigating the Jan. 6 riot. The committee has aimed to cut through to the public and make a case that Trump’s claims were connected to the Capitol attack.

A majority of respondents — 58 percent — said they were following news about the committee’s work at least somewhat closely, but 24 percent said they were not watching closely at all. Seventeen percent said they were watching its work not so closely.

The poll surveyed 1,524 adults nationwide between June 17 and June 20, with a margin of error of plus or minus 2.5 percentage points.

Source: TEST FEED1

House committee advances $840B defense bill to boost troop pay, offset inflation

The House Armed Services Committee in the early morning hours of Thursday voted to advance its $840 billion version of the annual defense policy bill, adding in more for extra ships, aircraft, Ukraine aid and to offset inflation.  

After a 16-hour markup session that stretched past 2 a.m., the committee approved its version of the National Defense Authorization Act (NDAA) for Fiscal Year 2023 by a vote of 57-1. 

During the marathon debate, the committee negotiated hundreds of amendments before sending the policy bill to the House floor. 

After the full House takes up the legislation in July, it will join the Senate’s version of the bill, passed by the Senate Armed Services Committee last week and head to the full Senate next month. After that, lawmakers from both chambers will work to negotiate a final, combined compromise. 

Committee Chairman Rep. Adam Smith (D-Wash.), praised the bill’s passage as “a powerful, bipartisan message to our allies and partners, global competitors, and the American people: democracy still works – and it can deliver real results.” 

In a statement after the vote, Smith said the legislation “supports the largest service member pay raise in decades, expands the talent pipeline, and partners with research institutions to accelerate the development of cutting-edge technologies that will support those in uniform.”  

Among the biggest amendments added was one proposed by Reps. Jared Golden (D-Maine) and Elaine Luria (D-Va.), to increase the defense budget by $37 billion. 

Though Smith opposed the amendment, it passed the committee by a vote of 42-17. 

The Senate Armed Services Committee, meanwhile, has proposed a $45 billion increase, a difference that will be ironed out in conference later this year.  

The House bill also offers a 4.6 percent pay raise for troops in 2023 — the largest in two decades if enacted.   

The pay bump, which mirrors the Pentagon’s requested pay raise, would go into effect Jan. 1.

In addition, the bill would pay for eight new battle ships, including two Virginia-class submarines and three guided-missile destroyers. 

Several other highly watched programs received full funding, such as the Columbia-class ballistic missile submarine and the B-21A bomber. 

As for vehicles and tanks, the bill pays for 44 Abrams tank upgrades, 102 Stryker Vehicle upgrades, and another 61 F-35 Joint Strike Fighter aircraft. 

The legislation also includes funding for ships, vehicles and missile launchers the Pentagon didn’t initially ask for in its version of the bill, including $3.6 billion for another destroyer, a frigate and two medical ships, among other vessels.  

An extra $2 billion would be spent on eight additional F/A-18 fighter jets and other Navy aircraft, and $1.2 billion for four additional Patriot surface-to-air missile systems and 20 additional Terminal High Altitude Area Defense interceptors. 

The legislation also funds $550 million for additional Ukraine lethal aid and for “advance planning to support U.S. presence on the Eastern front.” 

And to offset the rising inflation in the past several months, the bill includes $3.5 billion for extra costs associated with military construction, $2.5 billion for fuel and $1.4 billion for an additional inflation. 

Source: TEST FEED1

Prince William and Kate get their first official portrait together

Prince William and Kate, the Duchess of Cambridge, are posing for their first official portrait together.

The royal couple said they were “delighted” to see the first joint portrait of themselves unveiled at the University of Cambridge’s Fitzwilliam Museum in the United Kingdom on Thursday, where it will be on display for three years before heading to other spaces.

The portrait is by British artist Jamie Coreth.

The artwork was commissioned last year by the Cambridgeshire Royal Portrait Fund as “a gift to Cambridgeshire,” Kensington Palace said in a statement.

Coreth “worked to incorporate the City of Cambridge into the portrait by painting the background with the tones and colours of many of the historical stone buildings that are synonymous with the city,” according to a statement.

Kate, embracing William while wearing an emerald green dress, is seen gazing off to the side along with her husband, who has his hand in a pocket. Both are sporting slight grins in the painting.

Coreth said he aimed to show the pair “in a manner where they appeared both relaxed and approachable, as well as elegant and dignified.”

“As it is the first portrait to depict them together, and specifically during their time as The Duke and Duchess of Cambridge, I wanted the image to evoke a feeling of balance between their public and private lives,” Coreth said.

Source: TEST FEED1

Most women unaware of increased risk for Alzheimer's

An overwhelming majority of women are unaware they face an increased risk for Alzheimer’s disease compared to men and have not had conversations with their doctors about the aspects of their health that make them more likely to develop the disease, according to a new survey. 

The survey from the Women’s Alzheimer’s Movement at the Cleveland Clinic found 82 percent of women do not know they are at increased risk for Alzheimer’s, despite the fact that women make up nearly two-thirds of Alzheimer’s cases in the U.S. At least 4 million of the 6 million people age 65 and older with Alzheimer’s in the U.S. are women, and a woman’s estimated lifetime risk of developing Alzheimer’s at age 65 is 1 in 5. 

According to the survey, 73 percent of women have not talked about their brain health with a physician and 62 percent have not discussed menopause or permenopause, an area of health that research suggests should be monitored closely in relation to the disease. 

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Recent research has suggested hormonal shifts that occur with menopause can increase the risk of brain changes associated with Alzheimer’s. Seventy-one percent of respondents, however, said they had seen a physician in the past year and nearly 60 percent rated their health as good. Just 12 percent of women said they were aware of a potential link between estrogen loss and higher risk for Alzheimer’s. 

It’s not entirely clear why more women develop the disease, although women tend to live longer than men and the greatest risk factor for Alzheimer’s is age. One contributing factor may be the fact that women have stronger immune systems than men, which may result in women having more amyloid plaques than men. Amyloid plaques that cause Alzheimer’s may be part of the brain’s immune system response to fight infections, according to Harvard researchers. 

“We know that women’s unique biology and experiences over the course of their lifetime do play a role in Alzheimer’s disease, and this survey illustrates the need to inform women of this link and empower them to start having conversations with their providers now so they can prioritize their brain health and improve overall health outcomes,” Beri Ridgeway, Cleveland Clinic’s chief of staff, said in a statement. 

As research has shown Alzheimer’s could be prevented through healthy lifestyle changes, the survey found most women are highly motivated to exercise regularly, eat a healthy diet, get better sleep and maintain a healthy weight to reduce their risk of developing the disease. 

Source: TEST FEED1