Member of FDA’s expert panel resigns over controversial Alzheimer’s therapy approval

first_img Andrew Joseph [email protected] Related: “We recognize that there has been tremendous public interest in aducanumab and differing viewpoints on the extensive and complicated data supporting the application for aducanumab,” Dunn wrote. “Our discussions leading up to the decision to grant an accelerated approval for aducanumab considered a wide range of views, both external and internal to FDA. We appreciate the comments from the advisory committee members and can assure you that we listened carefully and viewed the meeting proceedings as an important source of input as we discussed the appropriate action.”To Aaron Kesselheim, an advisory committee member and the director of Brigham and Women’s Hospital’s Program on Regulation, Therapeutics, and Law, Aduhelm’s approval didn’t just set “a dangerous precedent” for what kind of evidence an Alzheimer’s therapy would need to show to get the green light, “but even more broadly for the idea that a company can turn around and at the last minute seek [accelerated approval] when their primary clinical endpoints in their trials don’t reach the level needed for FDA approval,” he told STAT in an email. BusinessMember of FDA’s expert panel resigns over controversial Alzheimer’s therapy approval 2Comments Related: 2Comments About the Author Reprints Biogen isn’t worried about backlash to ‘bewildering’ price of Alzheimer’s drug Leave this field empty if you’re human: With Aduhelm, the story is also more complicated than the FDA just rebuking the expert panel. The FDA granted the Biogen therapy what’s called an accelerated approval, based not on firm evidence the drug slowed cognitive decline — which even the FDA acknowledged was not clear — but on a “surrogate endpoint” that the therapy cleared toxic protein plaques in patients’ brains. In the FDA’s view, that finding “is reasonably likely to predict a clinical benefit to patients.” It also said Biogen would have to run another trial to confirm a clinical benefit, though the results of that aren’t due for nearly another decade.But during the advisory committee meeting last November, FDA officials explicitly said they were not considering approving aducanumab based on a surrogate endpoint. Billy Dunn, the director of the FDA’s Office of Neuroscience, made it clear: “We’re not using the amyloid as a surrogate for efficacy.”  That meant the panelists were not asked to consider that possibility. @DrewQJoseph General Assignment Reporter Andrew covers a range of topics, from addiction to public health to genetics. ‘The price is bewildering’: The cost of Biogen’s Alzheimer’s drug may lead payers to erect roadblocks Please enter a valid email address. Following the Food and Drug Administration’s polarizing authorization of the Alzheimer’s therapy Aduhelm on Monday, a member of an agency advisory committee that recommended against the drug’s approval has resigned.Neurologist Joel Perlmutter of Washington University in St. Louis, a member of the FDA’s expert panel for nervous system therapies, told STAT in an email that he had quit the committee on Monday “due to this ruling by the FDA without further discussion with our advisory committee.”The advisory committee, which convened in November, couldn’t have been more openly skeptical of the drug, also known as aducanumab. Ten of the 11 panelists found that there was not enough evidence to show it could slow cognitive decline. The 11th voted “uncertain.”advertisement Privacy Policy Jacquelyn Martin/APcenter_img By Andrew Joseph June 8, 2021 Reprints It is important, Emerson said, for outside experts to have a voice in the decision-making process.Matthew Herper contributed reporting.  Tags dementiadrug developmentFDApolicy Trending Now: Related: It’s no surprise that some members of the panel denounced the FDA’s approval, and not simply because of their votes. During the November hearing, some of them criticized how the data was being discussed and the evidence Biogen had submitted. Earlier this year, Emerson, Kesselheim, and a third panelist published a paper in JAMA outlining what they saw as the flaws of the therapy.Still, Emerson, the biostatistician, said he would serve on another advisory committee if asked. (The panels have some permanent members, but for individual hearings, they invite “temporary members,” which included Emerson in the case of aducanumab.) The FDA does not have to follow its advisory committees’ recommendations — one study found the agency went against the experts 21% of the time from 2008 to 2015 — but those overrulings generally came when the votes were closer. The FDA often convenes the panels when there is uncertainty around whether or how to approve new products, and there are different “ad comms” for different types of medications. Create a display name to comment This name will appear with your comment There was an error saving your display name. Please check and try again. 2Comments Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day. So on Monday when the agency announced it had indeed given Aduhelm the OK based on amyloid levels as a surrogate endpoint, it left experts on the panel scratching their heads. Trials of other amyloid-busting therapies have found that they didn’t result in clinical benefits.What had happened, Dunn explained in a letter to the chair of the panel Monday, was that after the panel hearing, there were “further discussions” within the agency that “raised further consideration of the accelerated approval pathway.” Elation, pride, and a slew of questions: Clinical trial participants reflect on their own complicated reactions to Aduhelm approval 2Comments Comparing the Covid-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson But the FDA still approved the treatment on Monday. On top of the potentially massive implications for patients, clinicians, and health care spending, the decision also raised questions about the role of the advisory committees — and what it meant that the agency, in its final adjudication, bucked the very panel it had convened.“This isn’t the first time when I was on a committee where the committee voted one way and the FDA decided another,” said biostatistician Scott Emerson, a professor emeritus at the University of Washington, who has served on many advisory committees in different disease areas. “This was the first time that nobody voted for approval of this drug — nobody — and they went against that.”advertisementlast_img read more

Good News is Good For You, Reports WTOP Radio

first_imgAddThis Sharing ButtonsShare to FacebookFacebookFacebookShare to TwitterTwitterTwitterShare to EmailEmailEmailShare to RedditRedditRedditShare to MoreAddThisMoreJournalist Bob Madigan came along on our “Good News Goes to Washington” cruise on the Potomac River. His report features sound from our chartered 85-ft yacht and, although it is just a minute long, really captures the spirit and message of the Good News Network.“Good News is Good For You,” the headline screams, and he talked to one of our Good News Ambassadors on board, positive psychologist Caroline Miller, saying there is science to prove it.The yacht party on September 9 celebrated the 15th anniversary of the Good News Network’s launch in 1997. The public as well as friends and reporters were invited on the free cruise aboard the second oldest yacht in the United States still being chartered.We were told that the vessel, Finished Business, was once used by President Richard Nixon during the Watergate hearings to escape to the Bahamas for some relaxation.On a sunny Sunday, a large banner, reading “Good News Goes to Washington”, was tied to the starboard side as she motored up the Potomac just offshore of the Jefferson Memorial and Washington monument.(LISTEN to the story from WTOP News)AddThis Sharing ButtonsShare to FacebookFacebookFacebookShare to TwitterTwitterTwitterShare to EmailEmailEmailShare to RedditRedditRedditShare to MoreAddThisMorelast_img read more

Advance International puts some wind into renewable energy sales

first_imgAdvance International Transport (AIT) is becoming increasingly involved in the shipment of modern wind turbines at a time when the world is waking up to advantages of environmentally sustainable power generation. Advance International Transport (AIT) is becoming increasingly involved in the shipment of modern wind turbines at a time when the world is waking up to advantages of environmentally sustainable power generation.Advance International Transport (AIT) is becoming increasingly involved in the shipment of modern wind turbines at a time when the world is waking up to advantages of environmentally sustainable power generation.last_img read more

Five questions for Ravens defense entering organized team activities

first_imgContrary to what you might conclude from this offseason, the Ravens do have another side of the ball.While spending most attention and resources on revamping the NFL’s 29th-ranked passing game, general manager Ozzie Newsome parted ways with only one player — defensive back Lardarius Webb — who played defensive snaps in 2017. That’s a remarkable level of continuity in this era, but will it pay off?The Ravens defense was exceptional at times in 2017, leading the league in takeaways and pitching three shutouts. The group ranked in the top 10 in most significant statistical categories until late in the season and still finished fifth overall in Football Outsiders’ weighted defense rankings.But the defense struggled down the stretch, blowing a late lead in Pittsburgh for the second year in a row and suffering one of the bigger collapses in team history when Cincinnati scored on a fourth-and-12 play from the Baltimore 49 with under a minute left in Week 17 to knock the Ravens out of the playoffs. No matter what the numbers said, the defense came up small in some of the biggest moments of the season.Below are five pressing questions for the Ravens defense as organized team activities are now underway:1. How much will change under new defensive coordinator Wink Martindale?Players have provided glowing endorsements of Martindale and anticipate more flexible and aggressive schemes than those employed by Dean Pees. Criticisms of the former defensive coordinator are fair — leaving Brandon Carr on an island with Antonio Brown late in the Week 14 loss to the Steelers was just one example — but these types of sentiments about new coaches are commonplace whenever teams fall short the previous season. It’s easy to subtly point fingers at individuals no longer in the picture, but Martindale’s roots with the Ryan family are definitely intriguing from a schematic standpoint. On the flip side, the former linebackers coach must prove his failed stint in Denver eight years ago was mostly due to the Broncos’ lack of talent since this defense has the talent to be a good-to-great unit.2. Who will man the inside linebacker position next to C.J. Mosley?This is likely a multi-pronged answer since former rookie free agent Patrick Onwuasor started 13 games at the weak-side spot and the dime package was frequently used in passing situations with an extra safety playing in the box last season. The Ravens should continue to be creative with sub packages, but they need more consistency at this position in the base defense, whether it’s Onwuasor taking the next step in his development or fourth-round rookie Kenny Young seizing the opportunity to get on the field. You’d expect Martindale to continue to use the likes of Anthony Levine and Chuck Clark in the dime package when appropriate, but Baltimore identifying another inside linebacker who can hold up in pass coverage will be vital to the overall success and flexibility of the defense.3. Will the Ravens get more out of safety Tony Jefferson?The prize free-agent acquisition of 2017 was ordinary in his first year with the Ravens, providing ammunition for critics who wondered why Newsome invested a four-year $34 million contract in a box safety when there were clear needs on the other side of the ball a year ago. Many point to Pees too frequently using Jefferson away from the line of scrimmage — a valid claim, especially in the first half of the 2017 season — but there were also examples of him being beaten in coverage by tight ends and not being as strong against the run as advertised. Martindale should continue using Jefferson in the box as much as possible, but Eric Weddle will need to be able to hold up in back-end coverage. Even after a restructure, Jefferson has the team’s ninth-highest cap number and must bring more to the table.4. What will the 5-technique defensive end spot look like?The season-ending loss of Brent Urban in Week 3 last season was unfortunate after the 6-foot-7, 300-pound lineman appeared on his way to becoming an impact player, and the Ravens struggled to fill this position for much of the season, another factor that hurt their run defense in addition to the four-game absence of Brandon Williams. Re-signing Urban to a cheap one-year deal was a prudent move, but counting on a player who’s missed 39 games in a four-year career is problematic at best. Carl Davis shifted outside to do a respectable job in the second half of last season, but he’s also entering the final year of his contract, making it critical for either 2017 third-round pick Chris Wormley or 2016 third-round pick Bronson Kaufusi to step up to become a real contributor at this spot.5. How will a deep group of cornerbacks be handled?On paper, this is one of the deepest cornerback groups the Ravens have ever had with young talents still pursuing their ceiling. Jimmy Smith’s health is the major question as he recovers from last December’s torn Achilles tendon, but Marlon Humphrey looked the part of a future shutdown corner as a rookie and the solid veteran Carr was retained as a pricey insurance policy. Beyond that, Tavon Young is back in the fold after serving as a strong slot defender as a rookie two years ago, and Maurice Canady will try to build on his late success at the nickel last season. Those numbers don’t even take into account fourth-round rookie Anthony Averett or Jaylen Hill, who showed potential last summer before being stricken with injuries. If all are healthy — a major if — Martindale will have a good problem on his hands.last_img read more

Kenya collects 10 points at opening Dubai 7s

first_img0Shares0000Nelson Oyoo in action against Uganda at the Dubai Sevens on Friday 1 December 2017NAIROBI, Kenya, Dec 2 – The national Sevens team collected 10 points in the opening leg of the 2017-18 HSBC Sevens World Series season after finishing eighth in Dubai 7s on Saturday.This is after they fell 12-19 to Australia in the 5th place semis to end their campaign of the weekend. Frank Wanyama and Nelson Oyoo scored Kenya’s tries in the defeat to Australia with Sammy Oliech completing one conversion.The team however, suffered injury blows after speedy winger Collins Injera and Dennis Ombachi missing Day 2 matches with knocks.Head coach innocent Simiyu will now turn attention to the second leg of the Series at Cape Town 7s next weekend in South Africa.Shujaa had narrowly lost 14-12 to New Zealand in the Main Cup quarters.Against the All Blacks, Kenya conceded a last minute try that saw them miss out a chance to play in the Main Cup semis for the first time since April 2016 when they lifted the Singapore 7s Cup.A fine first half display from Shujaa saw them lead 12-7 at the interval after turning tables that saw New Zealand sprint straight from kick-off for Dylan Collier to ground the converted try.Eden Agero restored parity to bring Shujaa back into the game after he snatched the fifty-fifty ball to scores under the posts for Sammy Oliech to convert.Oliech handed Shujaa the lead after receiving the ball from kick-off to ground under the post but they missed the conversion that came back to haunt them as that was those two points were the difference in the final whistle.A brave second half defensive effort for Shujaa was eventually cut short just before full time, Andrew Knewstubb kicking over the Shujaa defense to touch down, the ensuing conversion giving New Zealand the lead, their victory confirmed after a Shujaa handling error at the death.In the group stages, Kenya had lost 48-5 to South Africa after beating Canada 29-15 and Uganda 29-14.0Shares0000(Visited 1 times, 1 visits today)last_img read more

Store Clerk Accused of Killing Customer over Suspected Theft of Bag of Candy

first_imgIn Missouri, the St. Louis Circuit Attorney’s Office charged a 39-year-old gas station clerk with shooting and killing a person he thought had taken a bag of candy from his store. According to court documents, the shooting took place September 26 at a gas station in St. Louis. The victim, Christopher Simmons, was a customer at the gas station when he got into an argument with the store clerk, identified as Taleb Rebhi Ali Jawher. Jawher accused Simmons of stealing a bag of candy worth approximately $1.10 and pointed a handgun at him. Simmons then left the store. Jawher followed him outside and shot Simmons in the back of the head. Simmons did not steal or leave the store with the candy, police said. Jawher was charged with first-degree murder and armed criminal action.  [Source: Fox2 News] Stay UpdatedGet critical information for loss prevention professionals, security and retail management delivered right to your inbox.  Sign up nowlast_img read more

10 months agoWest Ham boss Pellegrini confident club and fans now behind him

first_imgWest Ham boss Pellegrini confident club and fans now behind himby Paul Vegas10 months agoSend to a friendShare the loveWest Ham boss Manuel Pellegrini is confident the club and fans are now united behind him.Hammers supporters sung their manager’s name for the first time since he took over in the summer as they made it four wins on the spin at Fulham last weekend.”Maybe we are starting some good days at West Ham, and we have to try and keep it that way until the end of the season,” said Pellegrini.”For me, having this good moment in the middle of the season is important for everyone.”The fans are loud in the stadium and the players are playing with more trust, but what is important is that we finish the season in the spot that this club deserves with the amount of people behind this club.”The London Stadium is now always full with fans and we need to feel that in every game. That is what we are trying to do now.” About the authorPaul VegasShare the loveHave your saylast_img read more

12 days agoPaul Elliott happy many ex-teammates now working at Chelsea

first_imgAbout the authorPaul VegasShare the loveHave your say Paul Elliott happy many ex-teammates now working at Chelseaby Paul Vegas12 days agoSend to a friendShare the lovePaul Elliott is delighted seeing many of his Chelsea teammates now working with the club.Elliott played for three years with the Blues.He told the club’s website: “I saw Dennis Wise not so long ago at the FA, he looks great, he is lighter now than when he was playing! I see Tony Cascarino periodically, he is a good lad Cas. I have not seen Andy Townsend for a while but I have seen Frank Sinclair. Eddie Newton is still doing some really good work at the club, and Andy Myers, and I am pleased the club has kept those players involved. That is very important and they are good role models for younger players.”Jason Cundy was another young player when I was at Chelsea. “I tried to help them along and they had a thirst for knowledge and a good attitude.” last_img read more

Florida Softball Mother Does Ridiculous Chicken Dance After Michigan Intentionally Walks Batter

first_imgFlorida Softball Mother does the chicken dance.Florida Softball Mother DanceAnyone who’s ever been to a college softball game knows that there is a lot of cheering and a lot of taunting. But one Florida softball fan (presumably the mother of a player on the team) took it to the next level Wednesday night.In the sixth inning, with Florida leading Michigan 4-1 in the championship game of the Women’s College World Series, the Wolverines intentionally walked Gators star Lauren Haeger both to avoid her and set up a potential double play. It did not sit well with everyone in attendance.Nice chicken dance, Florida Mom.— Drew Hallett (@DrewCHallett) June 4, 2015The move did eventually pay off, as Michigan got out of the inning without any damage. But Florida still won the title. We’ll assume this woman was happy with the overall result.last_img read more

Ontario will scrap cap and trade challenge Ottawas carbon tax Doug Ford

first_imgTORONTO – Doug Ford said Friday he will scrap Ontario’s cap-and-trade system and fight a federal carbon tax as soon as his Progressive Conservative cabinet is sworn in later this month because the measures hurt families and do nothing for the environment.To that end, the incoming premier said he will give notice of Ontario’s withdrawal from the carbon pricing market it shares with Quebec and California when he takes office on June 29.Ford, whose party won a majority of seats in last week’s election, said the government will provide clear rules for an “orderly wind down” of cap and trade, but did not specify when the legislature will be recalled to implement the bill needed to dismantle the system put in place by Kathleen Wynne’s Liberal government.“Today, I want to confirm that in Ontario the carbon tax’s days are numbered,” he said. “In fact, upon the swearing in of my new cabinet, at the top of our agenda the very first item will be to pass an order to cancel the Liberal cap-and-trade carbon tax.”Ford also said he would challenge the federal government’s rules requiring provinces to have carbon pricing in place.“I will (be) directing my attorney general to use all available resources, to use every power at the government’s disposal, we will officially challenge the federal government carbon tax on Ontario families,” he said. “Because the cap and trade and carbon tax does nothing for the environment.”During the spring election campaign, Ford’s team estimated challenging the federal carbon tax in court would cost taxpayers $30 million over four years.Environment Minister Catherine McKenna fired back, saying Ottawa is considering all options, including giving revenues from the carbon tax directly back to Ontario residents instead of the provincial government.“Climate change is real and its impacts do not stop with a change in government. Canadians expect us to take serious action to protect our environment and grow our economy,” McKenna said in a statement Friday evening.“Ontario’s premier-elect gave notice today that he is not interested in fighting climate change and is effectively withdrawing from Canada’s national climate change plan.”Eliminating cap and trade will help deliver on a campaign promise to cut gasoline prices by 10 cents per litre, Ford said, while adding that he was putting gas distributors “on notice” about price fluctuations ahead of holiday weekends.The cap-and-trade system aims to lower greenhouse gas emissions by putting caps on the amount of pollution companies in certain industries can emit. If they exceed those limits they must buy allowances at quarterly auctions or from other companies that come in under their limits.Ontario has made close to $3 billion in a series of cap-and-trade auctions since the system was introduced by the Liberals last year. Ford has consistently opposed carbon pricing and has come under fire for failing to explain how he would make up for the lost revenue.Trevor Tombe, an economist with the University of Calgary, said if Ford’s goal is to drive down gas prices he didn’t have to scrap the entire cap-and-trade system to achieve it. The Tories could have kept the program in place but exempted gas distributors who could have then lowered their prices by four or five cents.That combined with a cut to the provincial excise tax on fuel would lead to a 10-cent-per-litre cut at the pumps, he said.“Exempting fuel distributors would effectively turn cap-and-trade into a large emitter carbon pricing system,” he said.Tombe said there are no “insurmountable hurdles” that would keep Ontario from scrapping the system, but the government will need to address the billions in permits sold in previous auctions.“The money raised is earmarked for a number of spending initiatives,” he said. “The government could simply not proceed with those initiatives and instead return the money.”Quebec Premier Philippe Couillard said Friday that his position has not changed and that “the whole world is moving in this direction” to promote a carbon market or a tax to fight against climate change.“This is the fundamental measure. All the evidence is there,” he said, adding that Quebec would continue in the same direction as California.“It is believed that every Canadian province must make a visible and practical commitment to the fight against climate change.”The opposition parties expressed concern about the loss of revenue from cap and trade and the programs the money would have supported.“How will Mr. Ford replace the $1.9 billion per year that the cap-and-trade auction brings in for the province?” said NDP legislator Peter Tabuns. “Will he be making another $2 billion in cuts to programs Ontarians count on?”Ontario Green party Leader Mike Schreiner, who was elected to the legislature last week, said cancelling pollution pricing without a backup plan would send a signal to clean companies that the province is not open for business.“It is unfortunate to see Mr Ford’s sloganeering and back-of-the-napkin ideas continuing post-election,” he said.Environmental groups panned the move, calling it a bad idea for the environment and Ontario’s economy.“By abandoning action on climate change, Doug Ford is simply raising the extreme weather tax which is already wrecking homes, crops and public infrastructure,” said Keith Stewart, a senior energy strategist with Greenpeace Canada.last_img read more