Month: June 2021

In largely symbolic move, Express Scripts ends coverage of Valeant drug

In largely symbolic move, Express Scripts ends coverage of Valeant drug

first_img Express Scripts, the nation’s largest pharmacy benefits manager, is excluding an expensive Valeant Pharmaceuticals diabetes drug from its list of medicines that are reimbursed. Jeff Roberson/AP “There’s more significance for public relations than formulary coverage,” said Adam Fein of Pembroke Consulting, which tracks pharmaceutical distribution. “Express Scripts needs to demonstrate to their clients that they’re getting tough with manufacturers, because a lot of health plans are questioning Valeant’s actions. But this is just one drug (that is being excluded). So the news has almost very limited impact on actual drug spending, but it’s a great way for Express Scripts to send a signal.”Indeed, in the face of rising drug prices, Express Scripts is trying to adopt a tougher public stance and over the past two years has grown increasingly assertive in restricting medicines that are listed on its national formulary. Last year, the company made headlines by playing off drug makers against one another to obtain lower costs for hepatitis C treatments.Express Scripts, however, cited another reason for its move — a deal that Valeant recently struck with Walgreens Boots Alliance, the big pharmacy chain, to sell many of its medicines at a discount. The benefits manager fears this might encourage the chain to bypass a lower-cost generic and, instead, “dispense Glumetza at a higher cost to consumers,” according to the note.Fein explained that benefits managers cannot easily substitute lower-cost generics for some Valeant drugs, because the product formulations are not always the same. This can make it difficult for benefits managers to place restrictions on the use of some higher-priced Valeant drugs, he said. And there are early indications that the deal with Walgreens is increasing prescriptions for Valeant medicines.“So the timing (of the move by Express Scripts) is tied to the deal, as well,” said Fein. PharmalotIn largely symbolic move, Express Scripts ends coverage of Valeant drug By Ed Silverman Feb. 1, 2016 Reprints Related: In the latest tussle over rising drug prices, Express Scripts, the nation’s largest pharmacy benefits manager, is excluding an expensive Valeant Pharmaceuticals diabetes drug from its list of medicines that are reimbursed.In explaining its decision, the benefits manager cited a need to “protect our clients and patients from wasteful, unnecessary” drug spending, according to a note posted on its website. Some industry experts, however, said the move appears to be public posturing to appease the company’s many clients.Express Scripts pointed out that Valeant increased the price of its Glumetza drug by more than 800 percent last year, but a “more affordable” generic version becomes available this week. The benefits manager also noted Valeant has a history of jacking up prices. Howard Schiller, the Valent interim chief executive, in fact, will testify before Congress this week about the company’s pricing.advertisement As a benefits manager, Express Scripts negotiates contracts for drug coverage on behalf of corporations, government agencies, and unions, among others. This means the company helps determine health plan pricing and access through formularies, or lists of preferred medicines.But until Valeant was criticized last fall for its dealings with Philidor Rx Services, a specialty pharmacy, which involved allegations of manipulating insurance reimbursements, one expert said most benefits managers were not scrutinizing the drug maker and its pricing. For instance, after that episode, Express Scripts moved to cut ties over similar concerns involving a different specialty pharmacy and another drug maker, Horizon Pharma.advertisement About the Author Reprints Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Express Scripts sued by compounding pharmacies for alleged antitrust practices Related: Tags Express ScriptsValeant PharmaceuticalsWalgreens An Express Scripts spokesman noted that most formulary changes are covered during an annual update provided each summer, but that changes are made “as needed during the year.”It is worth noting that, recently, Express Scripts also tried to put on a tougher face for its clients by warning about prices for new injectable, cholesterol-lowering meds even before they became available. And last year, Express Scripts ended coverage for about 1,000 ingredients used to make compounded medicines, mostly ointments, creams, and powders that are found in topical treatments. Express Scripts to cover low-cost alternative to $750 Turing drug [email protected] @Pharmalot Ed Silvermanlast_img read more

Is being transgender a mental illness? WHO classification system suggests it is

Is being transgender a mental illness? WHO classification system suggests it is

first_img It is, perhaps, a peculiar fact involving an obscure medical text, but it is one that is now taking on outsized importance: The World Health Organization, in a compendium of conditions and diseases, lists being transgender under the umbrella of mental illness.The WHO publishes a standardized coding system used around the globe to classify medical conditions, for research purposes and health-care billing. In the document, being transgender is currently included in a section with kleptomania (the overwhelming impulse to steal), trichotillomania (the compulsion to pull out one’s own hair), and pedophilia (a preference for having sex with children). Tags policytransgenderWHO Helen Branswell By Helen Branswell June 3, 2016 Reprints What is it? 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. Ted S. Warren/AP 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? About the Author Reprints Unlock this article — plus daily intelligence on Capitol Hill and the life sciences industry — by subscribing to STAT+. First 30 days free. GET STARTED Politics Is being transgender a mental illness? WHO classification system suggests it is @HelenBranswell Senior Writer, Infectious Disease Helen covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development. GET STARTED Log In | Learn More last_img read more

Cancer drug reports: no link between benefit and price, but that can change

Cancer drug reports: no link between benefit and price, but that can change

first_img By Meghana Keshavan Feb. 9, 2017 Reprints Pharma Tags cancerdrug developmentdrug pricing 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. [email protected] Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED About the Author Reprints What is it? Cancer drugs have been under a critical lens for many years now — and for good reason, according to a duo of new papers.Two thirds of recently approved cancer drugs just don’t work all that well, particularly when compared to their cost, according to a report in the Annals of Oncology. Another notable conclusion: The paper found no improved benefit from personalized medicine drugs, and first-in-class drugs. Biotech Correspondent Meghana covers biotech and contributes to The Readout newsletter.center_img 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. Cancer drug reports: no link between benefit and price, but that can change @megkesh Meghana Keshavan What’s included? Log In | Learn More Gerry Broome/AP GET STARTEDlast_img read more

Trump derides ‘slow and burdensome’ approval process at FDA

Trump derides ‘slow and burdensome’ approval process at FDA

first_imgPolitics Pablo Martinez Monsivais/AP WASHINGTON — President Trump on Tuesday called on the Food and Drug Administration to speed the approval of drugs to treat life-threatening diseases, deriding the agency’s current process as “slow and burdensome.”In an address to a joint session of Congress, Trump said that the FDA approval process “keeps too many advances … from reaching those in need.” 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. Trump derides ‘slow and burdensome’ approval process at FDA What is it? Log In | Learn More Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED By Sheila Kaplan Feb. 28, 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. What’s included? GET STARTED Tags drug developmentpolicyWhite Houselast_img read more

FDA panel says risk of opioid use in kids’ cough medicines outweighs benefits

FDA panel says risk of opioid use in kids’ cough medicines outweighs benefits

first_img By Ike Swetlitz Sept. 11, 2017 Reprints Why is whooping cough on the rise? Scientists disagree Related: HealthFDA panel says risk of opioid use in kids’ cough medicines outweighs benefits Leave this field empty if you’re human: But the agency decided not to follow the committee’s advice, limiting its warning to cover only children under the age of 12. A couple of attendees at Monday’s meeting asked why.“It was a difficult decision,” said Dr. Sally Seymour, the deputy director for safety in the division of pulmonary, allergy, and rheumatology products at the Center for Drug Evaluation and Research at the FDA, who participated in the 2015 meeting. “In the end, we came to the decision primarily on the data and where the cases were for respiratory depression and death, and they were primarily in children less than 12 years of age.”Those data come from the FDA Adverse Event Reporting System. Between January 1969 and May 2015, there were 64 reported cases of respiratory depression, which is incredibly slow breathing that leads to a buildup of carbon dioxide in the lungs. Twenty-four of those cases resulted in death in individuals younger than 18, according to the agency.  Twenty-one of those children who died were younger than 12.Seymour also noted that the FDA wanted to make sure that cough medicines containing codeine were available for older children who needed them, while keeping them away from children who might be more at risk of being harmed.Some committee members also brought up over-the-counter medications that contain codeine, and wondered whether they would be dealt with in a similar way to prescription medications.“We do think that, ultimately, whatever decision you make today with respect to what you would recommend for the prescription products will be — we will try to apply those consistent determinations to what is done with the OTC products,” said John Alexander, the FDA’s deputy director for the division of pediatric and maternal health in the Office of Drug Evaluation in the Center for Drug Evaluation and Research. Please enter a valid email address. APStock “It’s not clear to me that changing the age will have the largest impact on this, because most of the misuse that we’re seeing in adolescents is actually due to diversion, and not necessarily that kids are misusing the medications that are prescribed to them,” said Dr. Sharon Levy, assistant professor of pediatrics at Harvard Medical School and the director of the adolescent substance abuse program at Boston Children’s Hospital.Doctors on the committee mainly expressed concern not that kids will get addicted to codeine or hydrocodone in cough medicine prescribed to them — rather, that there’s little evidence the drugs work to treat cough in children, and there’s lots of evidence that they can have serious side effects. The body turns codeine into morphine, but at unpredictable rates, so the safe dose for one child could be deadly for another.“I haven’t … ever been taught that morphine is an appropriate anti-cough medicine,” said Dr. Kelly Wade, a neonatologist at the Children’s Hospital of Philadelphia. She added, “This is really historic and antiquated cough medicine.”Indeed, one committee member compared the question of the day to “Mrs. Winslow’s Soothing Syrup,” a 19th-century cough medicine, ridiculed as a “baby killer” in a 1911 American Medical Association publication, “Nostrums and Quackery.” The active ingredient in the syrup was morphine.The FDA already warned in August that cough syrup containing codeine should not be given to children younger than 12. If the agency acts in line with this advisory committee, it might consider expanding the warning for children up to age 18.The August warning came after a different FDA advisory committee meeting in December 2015. After the committee discussed the safety of codeine in children, a majority voted to recommend that codeine not be used to treat cough in children under 18. Newsletters Sign up for Morning Rounds Your daily dose of news in health and medicine. Tags infectious diseasepediatrics Privacy Policy ROCKVILLE, Md. — A federal advisory committee sent a strong message to the Food and Drug Administration on Monday, declaring nearly unanimously that the risks of using certain opioids in children’s cough medications outweighs the benefits.“We have a disease with a very low risk profile, yet we’re looking at a drug that has a risk of death,” said Dr. Christy Turer, an assistant professor of pediatrics, clinical sciences, and medicine at the University of Texas Southwestern. “That, to me, seems very disproportionate.”The recommendation by the FDA advisory committee was part of the agency’s ongoing effort to consider whether and how opiates and opioids should be used in medicine for children, an issue that has been the subject of hearings and warnings for a decade. The panel on Monday was convened to consider whether the benefits of children using cough medications containing codeine or hydrocodone outweigh the risks, focusing specifically on children in two age groups: those 6 to 12, for whom the FDA already recommends against using codeine for cough, and those 12 to 18.advertisement With increased public attention on prescription opioid abuse, the meeting was also cast as an attempt to think about the question of cough medicine in a new way, taking into account the broad public health implications of a world with more opioids.But a Harvard professor who gave a presentation at the meeting questioned whether focusing on age limits was the most effective way to stop abuse.advertisementlast_img read more

She said she had cancer, and neighbors opened their wallets. Then a stranger’s email raised questions

She said she had cancer, and neighbors opened their wallets. Then a stranger’s email raised questions

first_imgHealthShe said she had cancer, and neighbors opened their wallets. Then a stranger’s email raised questions Deokaran was well-placed to pull it off. She came to Westchester County three years ago to be with Parekh. In Parekh’s telling, the two met through Match.com, and their first date was on Independence Day, in 2012. First, they ate at a haunted-house-themed restaurant in New York City. Then, he took her to get her first tattoo: the symbol of an Om on her wrist. Two years later, they moved into a house together with her kids in the town where he had been living: Dobbs Ferry, one village over from Ardsley.She had mentioned to Parekh, during that first leisurely day together, that she’d had cancer in the past, but she was fine now. Then, one day, not long after they moved in together, she came home and told him her cancer was back. He remembers her saying he shouldn’t be frightened if her hair started to fall out.To Wootten, those circumstances were perfect. She was new enough to town that most people did not know her all that well, but was present enough to be trusted. Her kids provided an opening to the Panthers community, and they were young enough to help garner sympathy.“To me it was just lucky timing for her,” Wootten said. “We were easy prey, because that’s the type of community we are. People live here and have their kids go to school here, they shop here. Ain’t that America?”The thought reminded him of the ’80s rock song with that refrain, and he began to sing a raspy, mocking version of it: “Oh, but ain’t that America, for you and me.” He trailed off into laughter.The Ardsley High School football field. Enid Alvarez for STATThe most common moral, for this kind of story, is about as ancient as Aesop himself. The idea was touted in news stories and Department of Justice press releases: Fibbing doesn’t just take its toll on the fibber, but on everyone. Fraud erodes our trust, making us all less likely to give.That wasn’t the picture that emerged on a hot day in late September, as Deokaran’s son’s former football team took to the field. People weren’t thinking about the money they had lost from the spaghetti dinner, or about the refunds promised by GoFundMe for any online donations, or about how the case would play out in court as fall progressed. Instead they were thinking about ice-cold Gatorade from the concession stand. They were thinking of the mother who’d fainted from the heat as she watched the game. They were chanting “Oooh, ah, you wish you were a Panther! Oooh, ah, you wish you were a Panther!”A 10th-grade girl stood at a table near the stands, selling homemade bracelets to raise money for a local education and care center for those with Down syndrome. The cheerleaders posed with her before the game began, clutching blue and gold pompoms.“The community around here is very helpful,” said one dad, who was selling Panthers T-shirts. “I think they would do it again.”Wootten, though he was still angry, said the same thing as he took frozen pretzels from a package, dipped them in water, rubbed them in salt, and threw them on the grill: Ardsley would do it again, if another crisis occurred.That crisis was already happening, right then, in that last burst of summer. You could see it in the thousands of appeals for help on GoFundMe and YouCaring and other sites. Most of those patients lived in other places, though — communities where neighbors might be strangers, or where there wasn’t much cash lying around for fundraisers. They weren’t there in Ardsley to hold their caps over their hearts for the national anthem, or to see the Panthers score their first touchdown. They weren’t there to feel the breeze that started just before the second quarter. They weren’t there to hear the EMT sidle up to the concession stand after he’d cared for the fainted mom and say, “She’s all right now. You got a burger?” About the Author Reprints How a doctor stirred national demand for the Bridge detox device — without solid evidence it works Rob Wootten stands inside the Department of Public Works building in Ardsley, N.Y. Enid B. Alvarez for STAT Eric Boodman Related: @ericboodman Leave this field empty if you’re human: Three high school football teams acted as waiters, directed by a small army of moms. Wootten’s daughter painted faces. The Ardsley High School chorus sang. Deokaran was there with her sons, hugging donors, sitting with her boyfriend, laughing and applauding as raffle tickets were drawn. Around $16,000 was raised — so much money, Wootten said, that “we decided to break it into a few checks so she wasn’t impacted tax-wise.”advertisement By Eric Boodman Nov. 1, 2017 Reprints Related: The email had arrived a bit before sundown on Dec. 8, 2015. It claimed that Deokaran did not currently have cancer — though she might have in the past — and that she was now shaving her head to wheedle money out of her community. Wootten’s response was terse: “Who are you?”The answer came 32 minutes later. Deokaran’s boyfriend, Nikhlesh Parekh, had two children from a previous relationship. The tipster said that he was the person caring for them.“Thank you,” Wootten wrote. “I don’t know your intentions yet, but if you have any please keep me posted. I’ll get to the bottom of this.”The task wasn’t completely new to him. In the early 2000s, a well-placed friend helped Wootten land a gig as an investigator with the state Racing and Wagering Board, keeping tabs on charitable gaming events. He’d inspect bingo nights at churches and VFWs, Elks clubs, and Legion halls.“There’s also poker nights, there’s night at-the-casinos, there’s bell jar tickets, the scratch-off tickets and the rip-off tickets,” he said. “The proceeds from that stuff is regulated by the state, so that’s what I did: I followed where that money went.”Often, it was stolen. Sometimes it was simple stuff: People writing out checks to themselves. Other times they were complex schemes involving hundreds of thousands of dollars. He’d go undercover in Oswego and Utica and Syracuse. He and his collaborators would grow out their beards to blend in with scruffier crowds, looking for illegal gambling and drugs and guns.Once, he helped bust a plot in which one family enriched themselves by predetermining the lucky tickets. Another time, he investigated an employee of a Catholic church who put her kids through college with funds embezzled from charitable gaming. She eventually told the priest about it in the privacy of the confessional. “He didn’t want it to go to the press,” Wootten recalled, “and I said, ‘Father, with all due respect, if it does go to the press, then people will feel that much worse for you, and they’ll put a few more dollars in the basket.’”Cool as it was, the work kept him away from his family. Wootten felt guilty, eating in restaurants upstate while his wife was cooking for five kids. He quit around 2006 to repair roads and remove snow for Ardsley’s DPW, and, as if to make up for lost time, became Ardsley’s volunteer-in-chief: the cable committee, the Little League, the booster club, his Catholic church. A cancer diagnosis, for instance, often engenders such eye-popping bills that the threat of bankruptcy looms almost as large as the risk of death. So the reaction in Ardsley was only natural: To heal a patient’s body and soul, you need to minister to his or her bank account. It’s automatic, as reflexive as saying please.It’s also a scam artist’s dream. As Wootten put it, “Who’s going to question the fact that someone has terminal cancer?” Same goes for someone who claims that they’re a victim of the Boston Marathon bombing, or the Pulse nightclub shooting — which some fraudsters did.No one knows how much fundraising fraud is out there, but there’s enough — and few enough safeguards against it — that a woman named Adrienne Gonzalez founded a DIY watchdog in 2016. Her website is called GoFraudMe; Gonzalez has proclaimed herself its Benevolent Overlord. During the day, she takes calls to a tip line from her desk at a beverage company near Richmond, Va. She writes up her findings while watching Netflix at night.One of the GoFundMe pages set up to raise money for Deokaran after she said she’d been diagnosed with cancer. Screen captureGonzalez tracks all kinds of crowdfunding fraud, from fake funeral fundraisers to campaigns for nonexistent pets. She said accusations of cancer fraud are becoming more common, and are among the hardest to investigate.Partially that’s because of patient privacy laws. But there is also the dilemma that Wootten was facing: When dealing with allegations of health-related fraud, it’s hard to know who is telling the truth.“I get a lot of petty tips,” said Gonzalez. Some come from vengeful ex-spouses, others from nosy neighbors or Facebook friends who have decided the patient doesn’t need help with medical bills. “They think it’s fraud if somebody they don’t like is running a campaign,” she said. Some people even take their grudges all the way to the FBI.Then again, some tips merit a concerted investigation. Earlier this year, a Nevada woman was arrested on allegations that she’d pretended her son had leukemia, and held a memorial service for him in a casino, though he was very much alive. “She brought a substantial amount of food home, and the boy was curious about where all the food came from,” Carson City Sheriff Ken Furlong told STAT. An acquaintance of the family called the police, and Furlong is glad he did. “We were afraid that somebody was going to kill the child,” he explained.Many fundraising scams, like legitimate campaigns, yield fairly small amounts: The Nevada case involved an estimated $2,000. Jeremy Snyder, an ethicist at Simon Fraser University, near Vancouver, has compared personal fundraising campaigns to popularity contests. The better you are able to marshal social media, and the more plugged in you are to a wealthy community, the more you make. Deokaran was in affluent Westchester County; all told, she raked in over $50,000.Wootten didn’t know how seriously to take the complaint that arrived in his inbox. He couldn’t brush the email off, but he didn’t quite trust it either. He needed to figure out who was lying — and why. Please enter a valid email address. In early December, Wootten got an email from someone whose name he didn’t recognize. It began: “Hi Rob, It is with great regret that I must tell you that you … have been scammed.” Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day. Newsletters Sign up for Morning Rounds Your daily dose of news in health and medicine. Privacy Policy Even after Deokaran received the funds at a ceremony in the school auditorium, checks kept arriving at Wootten’s house. He had a pile of them waiting in his cabinet when, in early December, he got an email from someone whose name he didn’t recognize. It began: “Hi Rob, It is with great regret that I must tell you that you … have been scammed.”Wootten didn’t lose his cool — “I’m not a fricking snowflake, I didn’t melt,” he said — but he was mad. His spaghetti dinner had been publicized well enough to attract over 500 people. Why had this stranger waited until now to raise the alarm?The email also put him in a bind. If Deokaran was lying when she said she had cancer, Wootten’s whole community had essentially been robbed. If she did have cancer, though, and Wootten mistakenly accused her of fraud, he could ruin what little time she had left to live.Shivonie Deokaran and Nikhlesh Parekh at the spaghetti dinner fundraiser in Ardsley. Anne WhitmanWootten’s spaghetti dinner sounds like a scene out of Norman Rockwell, a quaint relic of an America long gone. Community fundraisers now unfold on the servers of GoFundMe and YouCaring instead of in the local firehouse, with selfies instead of speeches, clicks instead of cash in a jar. But you’re still often relying on your neighbor or your high school pal; you just don’t need to look them in the eye.The uneasiness Wootten felt that December night has, if anything, become more common. A webpage can be set up and beamed out to an entire social circle in minutes — Norman Rockwell, in Imax 3-D. And that makes it easier for the beneficiary to be an acquaintance and a fraudster at the same time.Behind that kind of fraud lies a staggering amount of medical need. GoFundMe was founded in 2010, and its number of medical campaigns jumped from around 8,000 in 2011 to some 600,000 in 2014. By 2015, the site had hosted over 1.8 million such pages. Some of those asking for help have no insurance. Others have insurance but can’t afford the medical costs that remain uncovered. Wootten and Thompson were buddies at the local Department of Public Works. Wootten was younger, and more of a ham, a teller of dad jokes both dirty and clean. He knew everyone, and was constantly guffawing, slapping backs, shaking hands. Everyone knew Thomspon, too: He had the kind of smile that puts you at ease. He’d owned eateries from the tri-state area down to Florida, and even now, after leaving the business, he was still known among the firehouse volunteers for his chicken oreganata.Together, they made a good fundraising team: One could wrangle a crowd and the other could keep it fed. The Greenburgh town supervisor had already helped promote a GoFundMe page for Deokaran, which had quickly generated over $10,000, but this spaghetti dinner would outclass that. On Sunday, Nov. 15, 2015, in the company hall above the fire engines, the department’s volunteers served up some 75 pounds of pasta, with 50 gallons of sauce that Thompson had concocted from six cases of canned tomatoes, 18 large Spanish onions, and over three pounds of garlic. The mince for the meatballs weighed as much as a small child. “I don’t know why anyone would think they would be able to get away with something like that.” Leave this field empty if you’re human: Still, he knew that good Samaritans weren’t always what they seemed, and he wondered about this man named Eric Barret who was suddenly telling him Deokaran’s cancer was a lie.His emails contained all kinds of accusations. He said that Parekh had missed child support payments, and listed the ways in which Deokaran did not seem believable. He said he’d seen a YouTube video in which she’d claimed that her cancer was better — “funny how she suddenly developed it again when money was involved,” he wrote. He wondered how she was able to run a marathon if she were so sick. He made comments about Deokaran and Parekh’s vacations, implying they had plenty of money. He encouraged Wootten to call the couple’s previous landlords for information on Deokaran’s alleged wrongdoings, and even provided their telephone numbers.Wootten’s replies bounced from gratitude to suspicion. “God forbid people think I’m in on something this vicious,” he wrote. When asking why no one else had said anything, Wootten added, “Not blaming you of course.” But later that evening, Wootten pointed out that Deokaran had not, in fact, done a marathon, but a walk, and questioned the relevance of what Barret was saying. “Where is the proof you are telling us the truth?” he asked.If Barret wasn’t going to provide any, Wootten was just going to have to find some himself. Crowdfunding of medical devices raises money — and questions Wootten remembers being greeted at the door by Parekh, who was holding back their dog, and he went in to kiss Deokaran hello while Parekh tried to put the mutt behind a gate on the steps. He began with niceties, settling on the couch across from where she sat with a quilted blanket on her lap.But the dog just kept barking and barking, the sound filling the house, making it hard to talk. Finally Wootten asked Parekh to let it out. “Maybe I’ll just become friends with him and I’ll shut him up,” he remembers saying.Wootten hoped the dog would put them all at ease, and now that it was sitting next to him on the couch, he started in. “Listen, the reason I’m here is nothing, I just wanted to let you know that I got an email from this guy …”The reaction to Eric Barret’s name was immediate. The scene that Wootten describes is one of despair: Deokaran, with her head in her hands, moaning “Oh, my God, oh my, God, he’s trying to ruin us,” the dog nosing off the couch and padding over to her, and Parekh coming to console her as well. Wootten couldn’t see any tears at first, and he thought that her crying might have been forced — but he also reminded himself that he knew little about cancer and its treatments. “I’m thinking maybe since she’s going through chemo, she can’t so easily cry,” he recalled.The tears, he said, came not long after. They said that Barret was Parekh’s ex’s boyfriend, and was just intent on making trouble. She described the costs of chemo, and all they were doing to stay afloat: her work in photography, his new businesses. She said her physician had died in the earthquake in Nepal. She said she could provide proof of her illness. General Assignment Reporter Eric focuses on narrative features, exploring the startling ways that science and medicine affect people’s lives. [email protected] Rob Wootten Wootten was exploding with questions. The earthquake in Nepal? What did that have to do with anything? How did she know what Barret’s emails had said before he was even able to tell her? But he didn’t ask any aloud. He wanted them to keep talking.“Before I left, I made it as if I was buddy-buddy with them, and I apologized for going there and getting her upset, and she understood,” he said. Then he drove back across the Saw Mill River to the Ardsley police department, and filed a formal complaint.Not long after, the couple abruptly moved to Orlando.Wootten (left) and Rick Thompson in the hall at the Ardsley firehouse where the spaghetti dinner was held for Deokaran. Enid Alvarez for STATIt was only later, after the FBI got involved, that more of the story began to emerge. The FBI had access to much that Wootten didn’t. Deokaran’s legal name, it turned out, was Vedoutie Hoobraj. Agents pulled her medical and banking records, interviewed her friends and acquaintances, consulted a forensic accountant. They found that the money she was collecting went into an account she used to pay rent and business expenses, but nothing that seemed cancer-related.They sought out the doctor at Memorial Sloan Kettering Cancer Center in New York who had supposedly died in the Nepal earthquake. The specialist was not only still alive, but also had no memory of ever encountering Deokaran, or of using an email account with which Parekh had said he’d corresponded to ask about how best to care for his dying girlfriend. That account, the agents found, had been created in 2014, two months before Deokaran’s first GoFundMe was set up, and deleted in January 2016, just after Wootten had first been tipped off.All that was laid out in the criminal complaint of wire fraud that the FBI agents filed in court. The very last piece of evidence was perhaps the most damning, and the most baffling. On Aug. 10, 2017, Deokaran “acknowledged … that she did not have leukemia during the period when the fundraising solicitations were made, and that she had ‘made a mistake’ she wishes she could take back.”She was arrested in Orlando the next day. Her lawyer is now trying to get the case resolved without a trial, and neither of them responded to repeated requests for comment.As the facts begin to fall into place, the motives remain obscure, even for someone like Wootten, who chased fraudsters for years.“I really don’t have a crystal ball, I don’t know why anyone would think they would be able to get away with something like that,” he said. “There are some people who’ve lost their jobs, who are desperate, but Shivonie and Nik, they were working, they had businesses.” ‘Silicon Valley arrogance’? Google misfires as it strives to turn Star Trek fiction into reality Related: Slowly, the idea took shape: Wootten would confront Deokaran. Her reaction would be the most convincing evidence. He asked the advice of one of his buddies who was the Greenburgh police chief as their kids dribbled up and down the basketball court, and passed by to chat with another friend who was an Ardsley detective. They both seemed to like the idea. His wife, though, didn’t agree. Nor did some of his other friends. “‘No, don’t go do that. It’s dangerous. They could hurt you,” he remembered them saying.Wootten told them they were right. Then, he made plans to go anyway, telling his wife he had a doctor’s appointment. “I went there behind my wife’s back, like I was cheating on her or something,” he said.He called the night before and asked Deokaran if he could stop by and chat the next day. He assured her nothing was wrong. The visit wouldn’t have been all that strange even if he hadn’t received Barret’s emails. After all, he had a pile of checks for her in his TV cabinet.At mid-morning, he drove over, emails in hand. He kept reminding himself that what he was about to do was heartless. It was entirely possible that she was really dying of cancer. He doesn’t like to admit that he was anxious, but he was. “The women got me nervous thinking they’re going to harm me or something,” he said. Please enter a valid email address. ARDSLEY, N.Y. — It was a small town, so small that it wasn’t officially a town, but a village tucked inside the municipality of Greenburgh. Occupying 1 square mile, and counting only 4,600 souls, it was a commuter’s dream: a tight-knit hamlet just north of Manhattan, seemingly immune from 21st-century isolation. As the deputy fire chief put it, “You know, it’s like living in a fishbowl. Everybody knows what’s going on.”So it didn’t take long for news of the diagnosis to spread. A mother of two boys at Ardsley High School told the football coach she had cancer, and the football coach told the president of the booster club, and the president of the booster club told the deputy fire chief. They hardly knew the woman in question — Shivonie Deokaran and her boys were relatively new to town — but these men knew they needed to help. The story was all too familiar: She had only 18 months to live. Her cancer treatments were exorbitant — and you could imagine all those debts falling on Deokaran’s teenaged sons once she was gone.First, they held a raffle. But then Rob Wootten, the president of the Ardsley Panthers booster club, and Rick Thompson, the deputy fire chief, came up with a more ambitious plan. The amount raised on the sidelines of football games — that would be seed money for a fundraiser big enough to tackle serious medical bills. It would be a spaghetti dinner to end all spaghetti dinners.advertisement Privacy Policy Tags cancerpatientslast_img read more

Coal miners frustrated as Trump administration suspends health study

Coal miners frustrated as Trump administration suspends health study

first_img Steve Helber/AP Log In | Learn More By Associated Press Nov. 11, 2017 Reprints Coal miners frustrated as Trump administration suspends health study GLEN DANIEL, W.Va.  — Chuck Nelson spent his life in this corner of Appalachia, working for years in the coal mines — a good job in the economically depressed area. But he says the industry that helped him earn a living cost him his health, and his wife’s, too.The 61-year-old Nelson blames his kidney and liver disease on the well water he drank for years, and his wife’s more severe asthma on dust and particles from surface mines near their home. Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED 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. Politics What’s included? About the Author Reprints Associated Press What is it? 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. Tags policypulmonaryresearchstatesWhite Houselast_img read more

Doctors hunt for hidden cancers with glowing dyes

Doctors hunt for hidden cancers with glowing dyes

first_img Trending Now: By Associated Press March 14, 2018 Reprints Leave this field empty if you’re human: The dyes are experimental but advancing quickly. Two are in late-stage studies aimed at winning Food and Drug Administration approval. Johnson & Johnson just invested $40 million in one, and federal grants support some of the work.“We think this is so important. Patients’ lives will be improved by this,” said Paula Jacobs, an imaging expert at the National Cancer Institute. In five or so years, “there will be a palette of these,” she predicts.Ryan Ciccozzi is taken to surgery at the Hospital of the University of Pennsylvania in Philadelphia. Matt Rourke/APMaking cells glowSinghal was inspired a decade ago, while pondering a student who died when her lung cancer recurred soon after he thought he had removed it all. He was lying next to his baby, gazing at fluorescent decals.“I looked up and saw all these stars on the ceiling and I thought, how cool if we could make cells light up” so people wouldn’t die from unseen tumors, he said.A dye called ICG had long been used for various medical purposes. Singhal found that when big doses were given by IV a day before surgery, it collected in cancer cells and glowed when exposed to near infrared light. He dubbed it TumorGlow and has been testing it for lung, brain and other tumor types.He used it on Ryan Ciccozzi, a 45-year-old highway worker and father of four from Deptford, N.J., and found hidden cancer near Ciccozzi’s heart and in a lung.“The tumor was kind of growing into everything in there,” Ciccozzi said. “Without the dye, I don’t think they would have seen anything” besides the baseball-sized mass visible on CT scans ahead of time. Now, dyes are being tested to make cancer cells light up so doctors can cut them out and give patients a better shot at survival.With dyes, “it’s almost like we have bionic vision,” said Dr. Sunil Singhal at the University of Pennsylvania. “We can be sure we’re not taking too much or too little.”advertisement Please enter a valid email address. Dr. Sunil Singhal (center right) views a monitor to look at a tumor in his patient, made visible with the use of a special camera and fluorescent dye. Matt Rourke/AP Related: Singhal also is testing a dye for On Target Laboratories, based in the Purdue research park in Indiana, that binds to a protein more common in cancer cells. A late-stage study is underway for ovarian cancer and a mid-stage one for lung cancer.In one study, the dye highlighted 56 of 59 lung cancers seen on scans before surgery, plus nine more that weren’t visible ahead of time.Each year, about 80,000 Americans have surgery for suspicious lung spots. If a dye can show that cancer is confined to a small node, surgeons can remove a wedge instead of a whole lobe and preserve more breathing capacity, said On Target chief Marty Low. No price has been set, but dyes are cheap to make and the cost should fit within rates hospitals negotiate with insurers for these operations, he said.Big promise for breast cancerDyes may hold the most promise for breast cancer, said the American Cancer Society’s Dr. Len Lichtenfeld. Up to one-third of women who have a lump removed need a second operation because margins weren’t clear — an edge of the removed tissue later was found to harbor cancer.“If we drop that down into single digits, the impact is huge,” said Kelly Londy, who heads Lumicell, a suburban Boston company testing a dye paired with a device to scan the lump cavity for stray cancer cells. Newsletters Sign up for Cancer Briefing A weekly look at the latest in cancer research, treatment, and patient care. About the Author Reprintscenter_img Comparing the Covid-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson PHILADELPHIA — It was an ordinary surgery to remove a tumor — until doctors turned off the lights and the patient’s chest started to glow. A spot over his heart shined purplish pink. Another shimmered in a lung.They were hidden cancers revealed by fluorescent dye, an advance that soon may transform how hundreds of thousands of operations are done each year.Surgery has long been the best way to cure cancer. If the disease recurs, it’s usually because stray tumor cells were left behind or others lurked undetected. Yet there’s no good way for surgeons to tell what is cancer and what is not. They look and feel for defects, but good and bad tissue often seem the same.advertisement Tags cancerpatients A device called MarginProbe is sold now, but it uses different technology to examine the surface of tissue that’s been taken out, so it can’t pinpoint in the breast where residual disease lurks, said Dr. Barbara Smith, a breast surgeon at Massachusetts General Hospital.She leads a late-stage study of Lumicell’s system in 400 breast cancer patients. In an earlier study of 60 women, it revealed all of the cancers, verified by tissue tests later.But it also gave false alarms in more than a quarter of cases — “there were some areas where normal tissue lit up a little bit,” Smith said.Still, she said, “you would rather take a little extra tissue with the first surgery rather than missing something and have to go back.”A monitor displays a tumor in a patient, made visible with the use of a special camera and fluorescent dye. Matt Rourke/APOther cancersBlaze Bioscience is testing Tumor Paint, patented by company co-founder Dr. Jim Olson of Fred Hutchinson Cancer Research Center and Seattle Children’s Hospital. It’s a combo product — a molecule that binds to cancer and a dye to make it glow.“You can see it down to a few dozen cells or a few hundred cells,” Olson said. “I’ve seen neurosurgeons come out of the operating room with a big smile on their face because they can see the cancer very clearly.”Early-stage studies have been done for skin, brain and breast cancers in adults, and brain tumors in children.Avelas Biosciences of San Diego has a similar approach — a dye attached to a molecule to carry it into tumor cells. The company is finishing early studies in breast cancer and plans more for colon, head and neck, ovarian and other types.Cancer drugs have had a lot of attention while ways to improve surgery have had far less, said company president Carmine Stengone.“This was just an overlooked area, despite the high medical need.”— Marilynn Marchione Associated Press HealthDoctors hunt for hidden cancers with glowing dyes Blood test may help predict which breast cancers will recur Privacy Policylast_img read more

Novartis paid Trump’s lawyer’s firm far more than any of its actual lobbyists

Novartis paid Trump’s lawyer’s firm far more than any of its actual lobbyists

first_img 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. Novartis paid Trump’s lawyer’s firm far more than any of its actual lobbyists Log In | Learn More 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. About the Author Reprints Senior News Editor GET STARTED What is it? What’s included? WASHINGTON — The $100,000 monthly fee Novartis paid a company set up by President Trump’s personal attorney to help it better understand “U.S. healthcare policy matters” in the Trump era is almost four times more than it paid any actual outside lobbyist in the same time period.None of the contracts for the nearly four dozen external lobbyists Novartis employs to help explain and advocate on health care policy issues came close to the amounts paid Essential Consultants LLC, according to a STAT review of the Swiss drug maker’s 2017 and 2018 filings.center_img By Erin Mershon May 10, 2018 Reprints Photo illustration: Dom Smith/STAT; Photo: Mandel Ngan/Getty Images Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Erin Mershon Politics Tags pharmaceuticalspolicyTrumpWhite House @eemershon [email protected] last_img read more

Male doctors said my ‘female’ cancer was incurable. Then a woman took command and gave me hope

Male doctors said my ‘female’ cancer was incurable. Then a woman took command and gave me hope

first_imgFirst OpinionMale doctors said my ‘female’ cancer was incurable. Then a woman took command and gave me hope Newsletters Sign up for Cancer Briefing A weekly look at the latest in cancer research, treatment, and patient care. But I wasn’t. Soon I could barely sip plain broth, yet my belly was bulging almost into the curve of pregnancy. The day I vomited blood, my husband rushed me to the nearest community hospital, not far from where we live in a village by the river Oise, northwest of Paris.This was strange territory. I had not entered a hospital since my daughter was born 21 years earlier. I was stunned to be hospitalized immediately, and then endured three weeks of a relentless series of blood tests, CT scans, and exploratory surgeries — tended by a parade of male doctors. My surgeon finally informed me that the tests indicated a rare form of peritoneal cancer.advertisement Newsletters Sign up for First Opinion A weekly digest of our opinion column, with insight from industry experts. Leave this field empty if you’re human: I learned, though, that others shared my concerns about the treatment of female illnesses. A 2013 survey of 13,000 women with ovarian cancer in my native state of California showed that nearly two-thirds did not receive standard care because they were patients at hospitals that didn’t treat many women with ovarian cancer. African-American women were even more likely to receive inferior care. The lesson was clear: Low-volume hospitals may not have access to gynecologic oncologists who are aware of the latest treatments with better success rates.I fled the hospital with advice from the nurses in my circle of family and friends, shepherded by my brother-in-law, a doctor in Sweden. He identified and arranged for my transfer to Gustave Roussy outside of Paris, one of the top cancer research centers in Europe. It was an hour and a half commute from my home to this vast cancer land, a campus where about 50,000 French and international patients are treated annually.The reception area had the brisk efficiency of an airport check-in desk, dispatching visitors to numbered sections for blood tests, chemotherapy, the surgical wards, and a style center selling chic turbans and makeovers for cancer patients. Like most patients in the French system, my care was 100 percent covered by the state, including the wig I eventually needed.And here, at last, a woman took command of my care as the leader of an ovarian cancer research project. This oncologist listened to my questions. She explained medical approaches. She promised me that her goal was a cure instead of surrender. And she was the very first to propose immunotherapy, which harnesses the patient’s own immune system to attack cancer. It is an approach that has revolutionized the treatment of many forms of the disease and, earlier this month, reaped a Nobel Prize for two scientists, one in the United States and the other in Japan, whose work led to the development of this groundbreaking approach.I enrolled in a new trial of just six women with ovarian-related cancer, knowing all too well that immunotherapy is not always successful and there is a randomness about who survives and who succumbs. Privacy Policy By Doreen Carvajal Oct. 4, 2018 Reprints Please enter a valid email address. @dorcarvajal Leave this field empty if you’re human: I took my daughter to one of my follow-up exams so she could meet the woman who helped save my life. While we waited in a corridor for the appointment to start, my daughter asked me a surprising question: “Would you ever again let a male doctor treat you for a woman’s illness?”I paused. “Maybe not,” I told her, and then backtracked. “I’m not sure.” But her question prompted me to send an email along with my medical charts to my first surgeon, who had assured me on that distant winter day that my cancer was incurable.I told him that I wanted to share my positive results to help the next anxious woman who needs the newest alternatives for an ovarian-related illness. “Tell her to seek the research,” I wrote. “Give her the latest information. Give her hope.”Weeks later, I am still awaiting a reply. With impatience.Doreen Carvajal is a Paris-based journalist, author, and former reporter for The New York Times. Doreen Carvajal This merciless killer attacks the peritoneum, the thin layer of tissue that lines the abdomen, and seeds it with tiny tumors. Peritoneal cancer is furtive because the early, vague symptoms are often overlooked or mistreated and there is no screening test for it. Diagnosis usually comes late, after the cancer has spread. It is cared for in the same way as ovarian cancer, because the surface of the ovaries is made up of the same kind of cells that compose the peritoneum.Through the long days in the hospital, an odd question nagged me in my dreams and waking hours: How were these paternalistic doctors so confident about their edicts for women? It gave me solace to challenge them with questions. After an eternity in the journalism business, it was all I knew how to do. What about alternative treatments at other hospitals? New medical techniques? Fresh hope? But clearly it annoyed my doctors.Every hospital, the surgeon assured me, follows the same standard treatment. Another physician grew exasperated with my questions about test interpretations. He snapped at me for interrupting him; for not behaving like a patient. “Madame, you are too impatient.”I had no choice. Time was the very thing I was losing. In that instant, as the doctor turned his back on me and rushed away to see other patients, I made a decision to be my own advocate. Panicked, I started researching online from my hospital bed and reading studies. Prognosis: bleak. When my silent assassin emerged last autumn, I pressed my surgeon about the prognosis for a form of peritoneal cancer that strikes women in stealthy fashion.“Do you really want to know?” he replied. “Your cancer is incurable.” As I gazed at him in disbelief, he coolly recommended palliative care at a nearby regional hospital with an easy commute. My memory of this moment has a Caravaggio-like quality, a camera obscura scene of shadows and shock. I did not weep. I rebelled. I raged at the notion of being ushered toward a comfortable death by male doctors from a community hospital who confidently assured me that this was the sole treatment for a female malady.I had ignored the symptoms for long enough that it appeared to my physicians to be too late for aggressive action. Last November, on a Thanksgiving journey to New York, I noticed I wasn’t hungry, and blamed my lack of appetite on enormous New York restaurant portions. But when I returned home to France, waiters were prodding me to eat my comfort cuisine: a warm goat cheese appetizer or puréed potatoes. “Is there something wrong with the food?” they asked. Embarrassed, I assured them the food was fine.advertisement Please enter a valid email address. Biopharma has a new big idea for making cancer immunotherapy work better Related: By the time my treatment started with a more classic chemotherapy in mid-February, the assassins inside me had multiplied into an angry horde. Blood tests measured their presence through CA125, a protein used as a marker for ovarian and peritoneal cancers. A normal range is zero to 38. My count had soared toward 22,000.When immunotherapy was added, I settled every three weeks into a chair beside an IV pole with tubes of liquid drugs running to a port implanted in my shoulder. I wore earbuds blasting a playlist of soundtrack music from spy movies. To the beat of “Kill Them First” from “Skyfall,” I imagined my white blood cells hunting down my enemies.Under ordinary circumstances, immune cells try to attack tumors, but are fended off by a molecular shield. The immunotherapy drugs transformed my white blood cells into a deadly resistance force that crushed the shield and destroyed the lurking tumors. I experienced no major side effects, although I was fatigued for days after the infusions.To my amazement, I emerged as the poster girl for my tiny trial. With the addition of immunotherapy, over the weeks my CA125 count started plunging dramatically to a normal count of four. After a hysterectomy as part of my treatment in May, my new surgeon examined the dead cancer tissues and rushed to tell my oncologist that “something is really working.” A month later, my oncologist used my chart to illustrate the power of immunotherapy to researchers in France and others in England, where she delivered a lecture, “Immunotherapy: Hope or Hype?”The author’s oncologist used the remarkable decline in her CA125 biomarker in a presentation about immunotherapy. Courtesy Doreen CarvajalSome days I gasp involuntarily for air, savoring this new hope. Today, 10 months after my symptoms first appeared, I am cancer free. Researchers are analyzing my tissues to see if there might be a genetic reason to explain why I thwarted cancer while the other women in my tiny group made progress, but not to the same extent. Six more women have begun another trial. Related: Privacy Policy About the Author Reprints Molly Ferguson for STAT Nobel Prize in medicine awarded to two cancer researchers for immune system breakthrough Tags cancerimmunotherapyphysicianslast_img read more