NFL’s ‘unrestricted’ grant to fund brain research has strings attached

first_img By Ike Swetlitz Jan. 8, 2016 Reprints The agreement also commits the foundation to set up a “stakeholder board” to let the NFL and other donors talk with the NIH’s scientific leadership to “express viewpoints, address challenges, share expertise, and develop common perspectives on issues relating” to the research. The NFL’s $30 million donation to the NIH’s foundation to study concussion and brain trauma has strings attached. Michael Dwyer/AP Tags concussionshigh impactNIHpolicy NFL NIH Agreement 2680012-MOU-NIH-FNIH-NFL (PDF)
2680012-MOU-NIH-FNIH-NFL (Text)center_img Neither the foundation or the NFL responded to multiple requests for comment.ESPN reported late last month that the NFL refused to allow its donation to be used to pay for an ambitious national research project on the degenerative brain disease known as CTE, or chronic traumatic encephalopathy. The project is being led by Boston University’s Robert Stern, a prominent CTE researcher. Stern’s colleague at the university runs a “brain bank” whose researchers have diagnosed CTE in scores of former NFL players.The NFL strenuously denied the ESPN report, saying it had no “veto power” over how the foundation spends its $30 million gift, which was announced back in February of 2013.The foundation also denied the report, saying “the NFL has no control over the use of these grant funds.”But the document obtained by STAT through a public records request seems to contradict those assertions.It’s a memorandum of understanding between the NIH and the foundation, a nonprofit set up to work with the private sector to supplement federal funding for scientific research.The agreement specifically concerns the Sports and Health Research Program, which was launched in 2013 with the $30 million NFL grant. The NFL said at the time it expected the money would be spent on cutting-edge research into brain trauma, as well as studies of other health issues that afflict athletes.[stat_brightcove id=”4664703562001 ” credit=”Alex Hogan, Hyacinth Empinado/STAT”]The agreement makes clear that the NIH will take charge of managing and implementing any scientific research funded by outside donations, including the NFL grant. But before that research can even get off the ground, the NIH and the foundation must seek “mutual agreement” with its donors on the scope and goals of the project.So far, the NFL money has been used to support several small research projects on spinal cord injury and a larger project on CTE with Boston University and Mount Sinai Hospital in New York. That project is focusing on understanding the prevalence of CTE and how it can be diagnosed during autopsy.The new national CTE research —  the one not funded by the NFL —  aims to figure out how to diagnose CTE in living patients.Four congressional Democrats this week demanded more information about the NFL’s role in funding brain trauma research. “We are concerned about the potential implications of outside entities expecting to exercise ‘veto power’ or other influence over the selection of NIH research applicants,” Reps. Frank Pallone Jr., Gene Green, Jan Schakowsky, and Diana DeGette wrote in a letter sent to the NIH and the foundation. All four signatories are Democratic members of the House Energy and Commerce Committee. The letter was first reported by the Washington Post.The NIH said its director, Dr. Francis Collins, had received the letter and that the agency will respond. High ImpactAn occasional series on the science of concussions and how new findings are reverberating through sports and society.Concussion, Inc.: The big business of treating brain injuriesNFL union urges players to see ‘Concussion,’ but warns ‘it is scary’How the NFL’s concussion-spotting system is — and isn’t — workingNew study will examine NFL players’ brains in bid to spot CTEMy muddled brain: A fall, a concussion, and weeks of confusionA pill for concussions remains a brain-busting challengeAfter concussions, young football player’s plea: Donate my brain to scienceDisqualified after concussions, college football players recruited back onto the fieldCan chocolate milk speed concussion recovery? Experts cringeExperts debate: How many concussions are too many for an athlete? PoliticsNFL’s ‘unrestricted’ grant to fund brain research has strings attached advertisement When the National Football League announced a $30 million donation to the Foundation for the National Institutes of Health to fund research on concussion and brain trauma, the league called the grant an “unrestricted gift.”But it turns out there were strings attached.Before spending the money, the foundation must reach “mutual agreement” with the NIH and its donors — including the NFL — on the “research concepts” that will be addressed, as well as on “timeline, budget, and specific milestones to accomplish the research,” according to a signed agreement obtained by STAT.advertisementlast_img read more

Increased breastfeeding could save lives — if governments step up their game

first_img One of the most powerful lifesavers for babies doesn’t come from a pharmaceutical company. Instead, it comes from a mother’s breasts.That’s the takeaway from two papers published Thursday in the Lancet, in which researchers from around the world teamed up to analyze the scientific literature about breastfeeding.They found that increased breastfeeding worldwide could save over 800,000 children’s lives each year. And it could prevent 20,000 mothers from dying of breast and ovarian cancers, too.advertisement General Assignment Reporter Eric focuses on narrative features, exploring the startling ways that science and medicine affect people’s lives. Increased breastfeeding could save more than 800,000 children’s lives each year, according to a new analysis. Andrew Burton/Getty Images Related: “Breastfeeding is an exquisite personalized medicine,” said Dr. Cesar Victora, an epidemiologist at the Federal University of Pelotas, in Brazil, and a lead author of the papers. “There is a biological dialogue between mother and child. The breast milk may change according to the child’s need.”Victora’s comprehensive reviews come just days after the American Congress of Obstetricians and Gynecologists (ACOG) released a new set of guidelines urging physicians to support new mothers whether or not they choose to breastfeed.advertisement [email protected] Here’s what causes deaths among children worldwide These are just the most recent contributions to a long-standing debate as to whether breastfeeding is promoted too aggressively. HealthIncreased breastfeeding could save lives — if governments step up their game Eric Boodman The World Health Organization recommends that babies be fed nothing but breast milk for the first six months of life, and those guidelines have been taken up by many other organizations, including ACOG.But the US advisory group now wants to make sure that doctors are also taking patients’ choices into account.To Courtney Jung, a political scientist at the University of Toronto, that change is huge. She had been researching questions of race and indigenous identity, but she took a detour into the politics of breastfeeding when she became pregnant herself and realized what a hot-button issue it was. Last month, she published a book called “Lactivism.”“Right now, most of the initiatives that are advanced to promote breastfeeding are about putting more pressure on mothers to breastfeed,” she told STAT. “They’re not about supporting women’s own choices, and making it easier for them to choose to breastfeed.”Victora and his team are explicit: They don’t want to lay the blame on mothers for not respecting guidelines to the T. “We want to change the perspective from pointing the finger at women who don’t breast feed to pointing the finger at governments,” said Victora. And he singled out the American government as one of the worst.The United States is the only highly developed country that doesn’t give paid maternity leave, making it hard for American mothers to breastfeed their kids, Victora noted. He called on the US government and others to introduce more family-friendly leave policies, and to put limits on the advertising of formula.Those measures could go a long way to promoting breastfeeding, which is thought to save lives for a wide range of reasons. Breastfeeding can release hormones that decrease the mother’s risk of breast cancer, and at the same time allows her to pass on her defenses against microbes to her offspring. She also doesn’t have to worry about whether the water she is using to dilute formula is clean, which is of particular concern in the developing world.The papers also chronicle other benefits to breastfeeding, which include everything from slightly higher IQ levels to a richer gut microbiome.“The cognitive side of it is tremendously important,” said Susan Horton, an economist at the University of Waterloo, in Canada, and one of the authors of the papers.But the mechanisms that explain why breastfeeding can be so protective are still poorly understood. As Victora put it, “We’re still scratching the surface regarding the components that are present in breast milk.” @ericboodman About the Author Reprints By Eric Boodman Jan. 28, 2016 Reprints Tags breast cancerbreastfeedinginfant mortalitylast_img read more

Petition to FDA: Get the lead out of consumer hair dyes

first_img By Sheila Kaplan April 12, 2017 Reprints STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Unlock this article — and get additional analysis of the technologies disrupting health care — by subscribing to STAT+. First 30 days free. GET STARTED WASHINGTON — Back in 1980, when the Food and Drug Administration approved the use of lead acetate in hair dyes, little was known about the way skin absorbs toxic chemicals.The skin — and the scalp in particular — were considered tough barriers to break, and many public health officials believed that even if small amounts of lead got through, or were inhaled, it couldn’t really hurt anyone. What is it? Health Petition to FDA: Get the lead out of consumer hair dyes What’s included? Alissa Ambrose/STAT GET STARTED Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. Tags policySTAT+ Log In | Learn More last_img read more

Trump to sign bill extending veterans’ health care program

first_img By Associated Press April 18, 2017 Reprints Charles Dharapak/AP WASHINGTON — President Donald Trump plans to sign legislation to extend temporarily a program that gives veterans access to private-sector health care.White House spokesman Sean Spicer says Trump will sign the bill Wednesday at the White House. Politics GET STARTED Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED About the Author Reprints Trump to sign bill extending veterans’ health care program What is it? Associated Press Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. What’s included? Log In | Learn More Tags policyveteransWhite House STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.last_img read more

Reviving an old book to tell a new story about OxyContin, Purdue, and the Sackler family

first_img [email protected] Privacy Policy By Brian Meier June 6, 2018 Reprints Secret trove reveals bold ‘crusade’ to make OxyContin a blockbuster Book buyers didn’t agree and I was given an opportunity every author dreads — the chance to buy remaindered copies of the book for $1 apiece. There wasn’t even interest in a paperback, and the book’s original publisher returned all rights back to me. (In time, that proved to be a blessing, but it sure didn’t feel like it then.) According to the release, at a planned press conference Brownlee would personally thank me for writing about OxyContin, both as a New York Times reporter and as the author of “Pain Killer.” I was flattered, but asked him to delete the reference because I was reporting on the story and didn’t want to be part of it.The draft of attorney John Brownlee’s press release thanking reporter Barry Meier. Courtesy Barry MeierStill, I was happy that my work had had an impact, and after leaving the restaurant, I made a long drive to Abingdon, Va., a quaint town in the far western part of the state. It is home to the federal courthouse where the three Purdue Pharma executives would enter their pleas the following morning. Defense lawyers had asked Brownlee not to alert the news media to the plea deal until the three executives were back on a corporate jet returning to Stamford, Conn., where Purdue Pharma is based. But he had made one exception. As the three executives approached the courthouse, a New York Times photographer and I popped out from behind parked cars. The trio and their lawyers did not look happy to see us. Authors try to avoid writing the same book twice. I couldn’t.My book “Pain Killer” first came out in 2003. It was the first one to tell the story of OxyContin; its maker, Purdue Pharma; and the company’s wealthy and secretive owners, the Sackler family. The book appeared at the dawn of the opioid epidemic and the sun quickly set on it. A year after publication, it went out of print.To say I was disappointed is an understatement. I thought “Pain Killer” told an important story about the chaos unleashed when the best intentions of doctors to solve a problem — in this case, pain — get hijacked by the drug industry. The book’s account alone of Raymond Sackler, a little-known but pivotal figure who transformed drug marketing and compromised medical practice in the process, struck me as worth the price of admission.advertisement Trending Now: A decade later, lawmakers are now proposing that drug company executives found guilty of illegally marketing painkillers should be imprisoned. States and cities have filed lawsuits against Purdue Pharma and other opioid makers. Museums and institutions that received donations from members of the Sackler family involved with Purdue Pharma are facing scrutiny over those gifts.It struck me that the information unearthed by the Justice Department prosecutors can help inform those efforts. The mountain of evidence contained in the report also brings the story of OxyContin and Purdue Pharma full circle by providing an extraordinary inside look at the secretive drug maker’s early knowledge about OxyContin abuse and addiction. What prosecutors believed they had unearthed was a corporate cover-up with massive public health consequences.Given all this new information, it was clear to me that I had to write “Pain Killer” again. Like I said, authors would rather avoid writing the same book twice. But sometimes you have to.Barry Meier is a Pulitzer Prize-winning journalist and the author of “Pain Killer: An Empire of Deceit and the Origins of America’s Opioid Epidemic” (Random House, May 2018). Tags addictionopioids Newsletters Sign up for First Opinion A weekly digest of our opinion column, with insight from industry experts. A visitor photographs the “Prescribed to Death” memorial in Washington. The memorial consists of 22,000 engraved white pills. Each one represents the face of someone who died of a prescription opioid overdose in 2015. Mark Wilson/Getty Images Leave this field empty if you’re human: The cover of “Pain Killer,” 2003 (left). The cover of “Pain Killer: An Empire of Deceit and the Origins of America’s Opioid Epidemic,” 2018 (right). Courtesy Barry MeierIn the years that followed, the pace of the opioid epidemic accelerated and morphed. No longer was it limited to prescription painkillers like OxyContin but increasingly included heroin and deadly counterfeit versions of fentanyl. A wave of new books about the crisis appeared, most notably “Dreamland,” by Sam Quinones. “Pain Killer” became a touchstone often cited in these accounts. Some people even began describing the book as “prescient,” which I can assure you I am not.During those years, I turned my attention to a range of other subjects, including the case of a CIA consultant who had mysteriously disappeared in Iran. But not long ago, I came into possession of a document about Purdue Pharma and OxyContin that changed everything, including what I thought I knew about the story.It was a confidential 120-page report written by the U.S. Department of Justice team of prosecutors working for John Brownlee. Their investigation of OxyContin had culminated in the 2007 plea deal.Under that agreement, the three Purdue Pharma executives had pled guilty to a misdemeanor that held them liable only as the drug maker’s “responsible” officers and did not accuse them of any wrongdoing. But the report showed that prosecutors had recommended charging the men with serious felonies. It was also filled with a treasure trove of internal Purdue Pharma emails and records that offered a detailed look at what Purdue knew about OxyContin’s abuse and when the company knew it.Sadly, all that evidence was buried when top Justice Department officials in the George W. Bush administration refused to back prosecutors’ calls to indict the Purdue officials. Comparing the Covid-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson Brian Meier About the Author Reprints First OpinionReviving an old book to tell a new story about OxyContin, Purdue, and the Sackler family Fast forward several years to a May night in 2007. The scene is a Mexican restaurant in Roanoke, Va. Over dinner, the local United States attorney, John Brownlee, shows me the draft of a press release he plans to issue the next day, announcing a development that will make the front page of newspapers like the New York Times. Purdue Pharma and three of its top executives had agreed to plead guilty to charges in connection with the company’s deceptive promotion that OxyContin was less prone to abuse and addiction than traditional opioids.advertisement Please enter a valid email address. @pbmeier Related:last_img read more

Sepsis is the third leading cause of death. Can a new blood test change that?

first_imgHealth In his spare time, when he feels up to it, Ronnie Roberts walks through hospital parking lots slipping informational flyers onto every windshield.Roberts wants people to know the signs of sepsis, the body’s overwhelming response to a blood infection, which can lead to organ failure and even death. If he had known the signs and insisted that his fiancee was treated appropriately, he believes she’d still be alive. Ronnie Roberts spends his spare time handing out leaflets on the dangers of sepsis. He lost his fiancee, Dorice Broughton, to sepsis in 2015. Aram Boghosian for STAT @kweintraub What is it? Log In | Learn More Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Sepsis is the third leading cause of death. Can a new blood test change that? Karen Weintraub is an independenthealth/sciencejournalist, journalism teacher, and bookauthor. About the Author Reprints Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. By Karen Weintraub July 3, 2018 Reprints What’s included? STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Karen Weintraub GET STARTED Tags biotechnologydiagnosticsinfectious diseaselast_img read more

Lilly lowers most insulin costs to $35 a month in response to Covid-19

first_img Lilly lowers most insulin costs to $35 a month in response to Covid-19 An Eli Lilly factory in France produces insulin pens. Frederick Florin/AFP/Getty Images Tags drug pricing [email protected] Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED GET STARTED Pharmalot Log In | Learn More What is it?center_img Ed Silverman @Pharmalot STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. What’s included? In response to the financial hit many people are taking due to the coronavirus pandemic, Eli Lilly (LLY) is lowering the cost for most of its insulin products to $35 a month for anyone with commercial insurance or those who lack health coverage altogether.The move, which will also reset copay cards to the same monthly $35 level, comes amid ongoing angst over the cost of the diabetes treatment. Insulin, in fact, has been something of a poster child for the national debate over prescription drugs costs. By Ed Silverman April 7, 2020 Reprints Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. About the Author Reprintslast_img read more

Two Black university leaders urged their campuses to join a Covid-19 vaccine trial. The backlash was swift

first_img Comparing the Covid-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson By Nicholas St. Fleur Oct. 12, 2020 Reprints Walter Kimbrough, president of Dillard University, on its campus in New Orleans. Emily Kask for STAT “And then from a student’s perspective, there’s a lot of panic and trepidation about anything related to Covid right now,” Bartholomew said. He said he would not enroll in a clinical trial for a Covid-19 vaccine and he understands why other Black people wouldn’t either due to distrust of medical research.“Those horror stories are something that is part of our history as African Americans, so we’d be completely naive to ignore the precedents that have been set,” he said.The presidents responded to the social media criticism.“There was some misinformation that was being exaggerated,” said Verret. “The suggestion that there was money being paid to me or Dr. Kimbrough? No. That there was money paid to Xavier. No. That Xavier was requiring that all students be in the trial. No.” He added that any of the standard clinical trial compensation he received — participants are paid a nominal sum for their time — he would donate to his parish.The presidents’ letter may have helped make some headway in aiding recruitment, said Julia Garcia-Diaz, the principal investigator of the clinical trial at Ochsner. After it went out, she received an email from a woman in her late 60s who said she read the presidents’ note and wanted to sign up.“Not only was she elderly and African American, but she was a female also,” said Garcia-Diaz. “She ticked all sorts of boxes because women are also underrepresented in clinical trials.”Kimbrough said if he were to rewrite the letter, he would have addressed it to the general public rather than just his and Xavier’s campus communities.“That’s a good lesson in terms of messaging,” he said.The HBCU medical schools have been working to make sure they get the messaging right as they address people’s skepticism. Their outreach includes interacting with faith-based organizations and participating in virtual town halls, like one hosted in September by Howard University’s radio station and The Black Coalition Against Covid-19.“The major concern that people are expressing is the question, ‘Am I being experimented upon?’” David Carlisle, the president of Drew and an internist, said during the town hall. “I can assure individuals that this vaccine when you are taking it to fight Covid-19 is not an experiment that is being directed against the African American community.”He added that anyone considering enrolling should first ask their doctor if they should take this vaccine, why, and is this vaccine safe for them?At Morehouse, Valerie Montgomery Rice, the president and an OB-GYN, is no stranger to recruiting diverse populations into clinical trials. When she helped run a clinical trial for a birth control pill at the University of Kansas in the 1990s, her site was commended for recruiting the highest percentage of minority women in the country. She said she is confident 60% to 70% of the people enrolled in the vaccine trial on her campus will be people of color, because Morehouse has long cared for the community.“The benefit that is with an HBCU medical college is that we deal with these issues everyday with our community. We are more culturally sensitive and more culturally aware,” said Montgomery Rice. “We have the trust of the community and we’ve earned that trust.”Nicholas St. Fleur is a University of Michigan Knight-Wallace reporting fellow. @SciFleur “Our children are not lab rats for drug companies,” said one post. “I can’t believe a HBCU would do this to our people,” said another reply. “Tuskegee, Tuskegee. … Me and mine aren’t first in line,” said another response.Dillard University in New Orleans. Emily Kask for STATThe episode illustrates the challenges historically Black colleges and universities face as they seek to leverage their legacies of trust within African American communities to bolster lagging Black enrollment in Covid-19 vaccine clinical trials. Their recruitment efforts will need to overcome the deep-seated suspicions many Black Americans hold toward medical researchers, pharmaceutical companies, and the government that stem from long-standing racial injustices perpetrated by those institutions.advertisement Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day. [email protected] The presidents of two historically Black universities in New Orleans thought they were doing a public service by enrolling in a Covid-19 vaccine clinical trial back in August, so much so they urged their campus communities to consider doing the same.“I said we should inform our communities because I think there’s something about teaching by example,” said Reynold Verret, a biochemist who leads Xavier University of Louisiana. “We’re two Black men who rolled up their sleeves.”So Verret and Walter Kimbrough of Dillard University were stunned by the fierce backlash that followed their joint letter to faculty, staff, students, and alumni. Hundreds of outraged commenters flooded their schools’ Instagram, Twitter, and Facebook accounts.advertisement Now, as the four HBCU medical colleges prepare to host Covid-19 vaccine trials on their campuses, there’s hope their efforts will have more success.“We’ve engendered a level of trust with communities of color that other organizations, quite frankly, just don’t have,” said James Hildreth, an immunologist and president of Meharry College of Medicine in Nashville. “It’s imperative for us as HBCUs to rise to this occasion because people need us.”Meharry College plans to begin a trial of a vaccine made by Novavax within the next two weeks, with Hildreth as its first participant. The goal is to enroll 300 at the site, but Hildreth thinks they can enroll 600 people, mostly African Americans. The other HBCU medical schools, Howard University College of Medicine in Washington D.C., Morehouse School of Medicine in Atlanta, and Charles R. Drew University of Medicine and Science in Los Angeles, are planning to start their trials in the coming weeks. Nicholas St. Fleur Privacy Policy About the Author Reprints Leave this field empty if you’re human: “By engaging with the four Black medical schools,” Hildreth said, “they will have individuals who look like them, sitting across the table, having these conversations, and we think that’s going to make a huge difference.”As the death toll passes 210,000, the Covid-19 pandemic has laid bare inequalities within the U.S. health care system and labor force, with a large portion of Black workers employed in essential jobs that put them at risk of infection. Black Americans are three times as likely as white Americans to contract the disease, five times as likely to end up in the hospital, and twice as likely to die from it, according to the CDC. Had Black Americans died at the same rate as white Americans, some 20,800 Black people would still be alive.Yet, clinical trials for vaccines are struggling to recruit from their communities. Moderna, one of the drug companies testing a shot, slowed down its trial after failing to enroll enough people of color among its 30,000 participants — though as of last week it said one-third of volunteers were from “diverse communities.” Pfizer and BioNTech reported that 9% of their U.S. clinical trial enrollees are Black and 13% are Latino, while some 72% are white.“Watching all throughout the summer, you kept seeing stories that say there aren’t enough African Americans in these trials,” said Kimbrough. “You had people like Tony Fauci saying that’s going to be a problem if we create this vaccine and it doesn’t work for Black folks.”Though people are all nearly identical genetically,  people of color might respond differently than white people to a vaccine, especially for a respiratory disease, due to social differences such as exposure to air pollution that disproportionately affects Black and brown communities, or higher rates of chronic diseases such as diabetes or sickle cell.“How we live and where we live impacts how medicine affects us,” said Kimbrough. “I think that’s a powerful conversation that we need to be having.”He enrolled in a Phase 3 trial of the Pfizer and BioNTech vaccine after Verret mentioned in a phone call that he’d done the same, through New Orleans’ Ochsner Health system. The study is double-blinded, so neither the participants nor the researchers know whether they received the vaccination or a placebo until the trial is over. (Because the vaccine doesn’t contain any live virus, the participant has no risk of developing Covid-19 from the injection.)In their letter, Kimbrough and Verret addressed the pain caused by the Tuskegee syphilis study — in which Black patients were told they would be treated for the disease but weren’t — and how it eroded trust between the Black community and health care providers.“We understand they’re scared, we understand the history,” Kimbrough said, “but we’re not just telling them this, we’re saying, ‘Look, we’re doing this.’”Xavier University in New Orleans. Emily Kask for STATOutrage poured in nonetheless, fueled in part by a ProPublica story published a day before the presidents’ letter that found Ochsner had sent Black patients infected with coronavirus home to die despite the threat they could spread the disease to other people.To Tevon Blair, a 2018 Dillard graduate, part of what made the letter unpalatable was the absence of predominantly white local universities such as Loyola and Tulane.“The red flag in this vaccine trial … is that it is not a city-wide partnership with other colleges,” Blair tweeted.Myles Bartholomew, 22, a 2020 Xavier graduate who is pursuing his doctoral degree at Brown University in molecular biology, cellular biology and biochemistry, said that from a researcher’s point of view, he understood the importance of encouraging Black people to take part in clinical trials and said the presidents were acting unselfishly. Tags CoronavirusracismresearchVaccines General Assignment Reporter, Associate Editorial Director of Events Nicholas covers the intersection of race, medicine, and the life sciences. HealthTwo Black university leaders urged their campuses to join a Covid-19 vaccine trial. The backlash was swift Please enter a valid email address. Trending Now:last_img read more

Canada says drug spending keeps rising due to increasingly expensive specialty meds

first_img What’s included? Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. Log In | Learn More Adobe Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED GET STARTED Tags drug pricingSTAT+ What is it? Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Pharmalot center_img Canada says drug spending keeps rising due to increasingly expensive specialty meds By Ed Silverman March 26, 2021 Reprints STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Ed Silverman About the Author Reprints [email protected] As Canadians brace for new rules to address prescription drug spending, a government report found sales of patented medicines rose a “modest” 3.5% in 2019 and that prices were stable, but a growing number of increasingly expensive, specialized treatments are driving overall costs higher.Such medicines — such as biologics and cancer therapies — now account for approximately half of all sales of patented medicines in the country, a “dramatic” increase from 10% less than a decade ago, the report found. In 2009, only one of the top 10 selling patented medicines cost more than $1,000 a year. By 2019, seven of the top 10 had annual treatment costs exceeding $10,000 annually. @Pharmalot last_img read more

Huntington’s community grieves not just one therapeutic setback, but two

first_img A company called Triplet Therapeutics, which is focused on these so-called repeat expansion disorders, is pursuing an HD treatment based on this strategy.For now, though, patients and their families are trying to adjust to the trial news. Nathan Wilmoth, 43, of Brandon, Miss., was receiving injections in the Roche trial through last February, when a separate medical issue forced him to pause. He and his family were hoping that they could find a way to restart the therapy when Roche’s announcement came last month.They’re not sure if Nathan was receiving the placebo or tominersen, but they felt there were some improvements in his walking and cognition. But there’s also been disease progression in the past year. Nathan has more anxiety issues, and Heather holds his hand when he walks to keep him steady. His speech is slurring. For the community of people affected by Huntington’s disease — a group that is no stranger to disappointment — the back-to-back announcements last month still hit like a double whammy.First, Roche announced it was cutting off the dosing of its experimental therapy tominersen, in a closely watched, much-hyped Phase 3 clinical trial. Then, a week later, Wave Life Sciences said it was abandoning two Huntington’s therapies in earlier stage trials.“It was like a sucker punch twice within one week,” said Heather Thurgood Wilmoth, whose husband Nathan has Huntington’s and had been a participant in the Roche trial.advertisement APStock Research using brains-in-a-dish forces a radical rethinking of Huntington’s disease By Andrew Joseph April 13, 2021 Reprints HealthHuntington’s community grieves not just one therapeutic setback, but two About the Author Reprints As they wait for more details from the Roche trial, researchers still believe that reducing the mutant protein is a smart strategy. They just need to figure out how — perhaps a different dosage or starting treatment earlier in the course of the illness — to make a clinical impact.“I feel so committed to this huntingtin lowering therapy,” Vicki Wheelock, a neurologist at UC Davis Health, said about tominersen during the webinar. “This is engaging the target. This is the best thing that we’ve had so far.” The HD Society’s Yohrling told STAT there were other experimental therapies in trials or in preclinical studies that the community was keeping a close eye on. Many of them also are geared to lower mutant huntingtin levels, though in different ways. Among the companies developing HD treatments is uniQure, which is testing a gene therapy that’s designed to block production of the mutant protein. The company announced this month it had enrolled the first group of patients in its early-stage clinical trial.  Privacy Policy Trending Now: Related: The Roche news came as a particular shock — and as a devastation. No other treatment that’s designed to target the roots of the neurodegenerative illness had ever made it that far in the development gantlet, so there was a ton of hope and excitement imbued in the study. Adding insult: Families don’t know why the trial was upended. Roche said only that it was halting treatments based on the recommendation of independent data experts monitoring the trial. It’s still not clear what in the data led to that recommendation. People in the Huntington’s community described their reactions as if they were grieving a loss. There are no treatments that slow the course of the universally fatal disease itself, only that work to alleviate symptoms. advertisement Leave this field empty if you’re human: “This in no way alters our resolve to defeat HD,” he said. “If anything it makes it stronger. We know what causes HD, we know that we can lower the protein that we think causes HD. We just now need to figure out a safe and efficacious way, the best way to lower it. That’s where we are. We will do that, we will meet that goal.”Huntington’s is a genetic disease, but not one caused by a misspelling in the “letters” that make up DNA, like many inherited conditions. Rather, it occurs when someone has too many repeats of the letters CAG in a gene that encodes a protein called huntingtin. People who have 40 or more CAG repeats will develop the disease, often showing symptoms first in their 30s or 40s, while 35 CAG repeats or fewer is considered healthy. (People with a number of CAG repeats in the middle may show symptoms, but not until later in life.) Related: Comparing the Covid-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson “It felt like someone punched me in the stomach, and I started hysterical crying,” MaryAnn Emerick, who has HD in her family, said on the webinar about learning the Roche news. She added: “It felt like something was torn from me.”The data monitoring committee had not identified any new safety issues, Roche said, which led to speculation that perhaps the data were so clear that the therapy wasn’t having a benefit that there was no reason for the trial to continue. But at the time of the announcement, Roche hadn’t even seen the data from the study, and it’s still unknown what led the committee to make the recommendation to cut off dosing. Roche said it will share some preliminary data from the trial at a conference later this month, and is also asking participants to continue seeing their doctors so more data can be collected.Then, on March 29, Wave announced that it was shelving two experimental therapies that had failed to sufficiently lower mutant huntingtin levels in early-stage trials. “This is not the update we were hoping to provide, and we recognize this has already been an extremely challenging month for the HD community,” Wave wrote in a letter.  With more repeats, the longer the huntingtin protein stretches, and it becomes toxic to neurons. The result is a cruel mix of symptoms reminiscent of ALS, Alzheimer’s, and Parkinson’s all together: mood changes and impulsive behavior; trouble walking and talking and eventually swallowing; cognitive declines.One of the reasons the Roche trial had generated so much excitement was because in an earlier study, researchers had found that the therapy — delivered via an injection into the fluid that bathes the spine — succeeded in lowering levels of the mutant huntingtin protein. The hope was that that reduction could lead to clinical improvements, which was what the placebo-controlled Phase 3 trial was designed to test. But then, on March 22, Roche said it was stopping the dosing of both tominersen and placebo. A group called an independent data monitoring committee, which regularly reviewed the trial’s data as it was being generated, had recommended the company halt dosing “based on the investigational therapy’s potential benefit/risk profile for study participants.”  If you value our coronavirus coverage, please consider making a one-time contribution to support our journalism. center_img Right now, they’re trying to come up with plans to build a house that can accommodate Nathan as his disease advances, one with a shower that can fit a wheelchair so Heather can eventually wash him and one with a bedroom big enough for a regular bed and hospital bed. They’re having to anticipate when Nathan’s condition gets to that point.People participate in clinical trials in hopes not just that the drug in question might help them, but that the study might lead to better treatments for others. With Huntington’s, that desire can be personal. There’s a 50-50 chance that people who have the disease pass it on to their children, and Nathan has a 15-year-old and 6-year-old. (When people turn 18, they can choose to get a genetic test to find out whether they have the mutant gene or not.)“From a selfish standpoint, I’d like to have my husband for longer than just a few years,” Heather said. But she added: “There was a lot of hope that even if it didn’t help Nathan, it would help our kids.” Andrew Joseph [email protected] @DrewQJoseph Novartis, meanwhile, plans to start a trial this year for its oral drug branaplam, which was originally developed for the condition spinal muscular atrophy but in preclinical studies reduced mutant huntingtin. And while Wave abandoned two of its therapies, it is still moving forward with another, refined version of the same kind of compound, an antisense oligonucleotide. It plans to start a clinical trial this year. Beyond trying to decrease the mutant protein, another approach Yohrling outlined is halting CAG expansion. Blood tests may show that someone who carries the disease-causing mutation has, say, 42 CAG repeats in their gene. But as people get older, those repeats multiply in neurons and other cells, like a record skipping for longer and longer. The hypothesis, Yohrling said, is that “if we could stop the expansion, we could stop the disease.”  Brazilian judge temporarily suspends pharmaceutical patent extensions amid push to lower drug costs Related: Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day. Support STAT: Please enter a valid email address. Zhang and colleagues file patent to use CRISPR against rare genetic diseases General Assignment Reporter Andrew covers a range of topics, from addiction to public health to genetics. A clinical trial for Huntington’s opens the door to hope for some patients. Only so many can get in Related: But researchers, patients, and families also vowed to use the information gleaned from the studies to make progress moving forward. During a webinar put together after the Roche news, George Yohrling, the chief scientific officer of the Huntington’s Disease Society of America, described the pipeline for other potential treatments as “deep and diverse.”  Tags clinical trialsdrug developmentgeneticsrare diseaselast_img read more