first_img Patrick Skerrett By Patrick Skerrett Dec. 22, 2015 Reprints [email protected] The draft guidelines from the USPSTF look a lot like the guidelines published in 2013 from the American Heart Association and American College of Cardiology. Are they better?Patients and providers, including me, were confused by the 2013 guidelines. Why the task force has come out with its own similar — but different — guidelines adds to the confusion. For example, the American Heart Association and American College of Cardiology guidelines recommend starting a statin when the 10-year risk is 7.5 percent. The task force says 10 percent. I don’t think it makes public health sense to have multiple guidelines that don’t completely agree with each other floating around.These guidelines use cardiovascular risk to determine who should take a statin. Does that make sense?Using cardiovascular risk to determine whether to take a statin is definitely reasonable. But if you are going to make a risk-based guideline, the way you calculate risk must be very, very good. I and others have criticized the risk calculator used by the American Heart Association and American College of Cardiology guidelines. It understates the risk in some populations, meaning some people who could truly benefit from a statin wouldn’t be advised to take one, and overstates the risk in others. I don’t understand why the US Preventive Services Task Force would recycle this flawed calculator.advertisement First OpinionExpert view: New guidelines on cholesterol drugs are flawed Paul J. Richards/Getty Images @PJSkerrett center_img Editor, First Opinion Patrick Skerrett is the editor of First Opinion, STAT’s platform for perspective and opinion on the life sciences writ large, and the host of the First Opinion Podcast. About the Author Reprints What would make the calculator better?One thing I must emphasize: Before this calculator was made public in the 2013 guidelines, it had never been published in a peer-reviewed paper. The first time many of us saw it was the day it appeared as part of the guidelines. This calculator needs to be verified in various populations, and adjusted to improve its accuracy. It also excludes family history, one of the most powerful risk factors for cardiovascular disease. Risk calculators that include this information, like the Reynolds Risk Score, do a better job of estimating an individual’s cardiovascular risk.The USPSTF draft guidelines cover only individuals between the ages of 40 and 75. Does that mean older people shouldn’t take a statin?Truncating treatment recommendations at age 75 is not sensible. In an important trial called IMPROVE-IT, published earlier this year in the New England Journal of Medicine, the researchers found something remarkable. People under age 75 who took a statin plus another cholesterol-lowering drug called ezetimibe [a Merck drug marketed as Zetia] got very little benefit from the medications, while those over 75 benefited, meaning they had lower rates of heart attack or stroke or needing artery-opening angioplasty or bypass surgery.Statins aren’t risk-free. How do individuals and their doctors balance benefits and risks?Side effects are always a concern. People at low risk for a heart attack or stroke shouldn’t be taking a statin because they get little or no benefit while shouldering the possibility of harm. These include muscle pain and a possible small rise in blood sugar. But keep in mind that these risks are small, especially for the low and moderate doses of statins the task force is recommending. In addition, if these problems appear, stopping the drug eliminates the problem. These factors make it easier to recommend statins to a wider group of individuals, especially since cardiovascular disease is the leading cause of death in the United States and many other countries.If the guidelines are unclear, what’s the best way for individuals to answer the question, ‘Should I be taking a statin?’Find a thoughtful doctor who is independent and who won’t just parrot back the guidelines. He or she should be willing to talk openly about statin use and the prevention of cardiovascular disease. Nothing beats a conversation like that. Patients have different value systems, preferences, concerns, and issues such as family history that aren’t in the guidelines. Including these in the process known as shared decision-making is very powerful.If your doctor doesn’t really want to talk with you or share the decision making, find another doctor. Some seemingly healthy men and women could benefit from taking a cholesterol-lowering statin, according to draft guidelines published Monday by the US Preventive Services Task Force, an independent panel of clinicians established by Congress to develop federal guidelines for tests and treatments aimed at preventing disease.There’s little question that statins save lives when taken by individuals who have had a heart attack or stroke. Things are a bit murkier for adults without heart disease. The task force is now recommending a low- to moderate-intensity statin for 40- to 75-year-olds who might seem healthy but have a higher chance developing heart disease because of high blood pressure, high cholesterol, diabetes, or smoking.For perspective on the draft guidelines, I talked with Dr. Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic.advertisement Tags guidelinesheart diseasestatinslast_img read more

first_img Related: By David Nather Jan. 6, 2016 Reprints It also would almost certainly not involve Medicare officials sitting around a table, haggling with drug company executives over the price of every medication.“There’s a huge gulf between the political talking points and the practical execution,” said Dan Mendelson, president of the Avalere Health consulting firm and a former health care official in President Bill Clinton’s budget office. “It’s extremely difficult to structure the program so the negotiations desired by Congress would be productive.”advertisement That’s one reason the Congressional Budget Office, the official budget scorekeeper of Capitol Hill, has been reluctant to predict any actual savings through negotiations alone. Without a stronger ability to say “no,” the office wrote in its most recent analysis, the savings would be “negligible.”But if Congress takes the handcuffs off of the private plans and lets them use formularies that are more like large companies’ health plans, Outterson said, “that would save billions.”There’s just one problem: The Obama administration tried to do that on its own in 2014, proposing a change in the rules to get rid of some of the protected classes. A massive protest erupted, with drug makers teaming up with patient advocates and others to complain that Medicare drug coverage was being undermined. Congressional Republicans and Democrats complained, too. The administration quickly withdrew the changes.Another, simpler option is to have Medicare press for rebates similar to the kind Medicaid gets for drug coverage for low-income people.“That is a way to implement a negotiation. Of course, it’s not a true negotiation. It’s more the government using its executive authority to say, ‘We will get this discount’” or walk away, said Jack Hoadley, a Medicare Part D expert at Georgetown University and a former HHS official.Negotiating drug prices “almost certainly means some kind of automatic pricing (or rebating) formula, as Medicaid has,” health care economist Austin Frakt, the creator of the Incidental Economist blog, wrote in an email.A narrower version of that option would be to give the drug rebates to just one group of people: the 9 million low-income seniors and younger people with disabilities who are eligible for both Medicare and Medicaid. That’s the option both Clinton and Sanders chose for their plans.This group — called “dual eligibles” — used to get the Medicaid rebates before the Medicare prescription drug program was created, but those discounts ended when Medicare Part D was launched. It’s also an option that can be manipulated, critics say: If a drug company knows it has to provide a certain discount off of its base price, it can just raise the price.Even so, it is the rebates — not the negotiations — that are most guaranteed to produce actual savings. According to the Congressional Budget Office, the rebates could save the federal government as much as $103 billion over 10 years — a fact that both Clinton and Sanders noted in their drug plans. APStock PoliticsWashington has big hopes, but little power, to negotiate drug prices WASHINGTON — It sounds simple enough: Let Medicare negotiate drug prices and help bring down prices for consumers.With growing public frustration over the price of prescription drugs, Hillary Clinton and Bernie Sanders have made that idea a centerpiece of their campaigns, and congressional Democrats have been kicking the notion around in broad terms for years.But policy experts say the candidates and lawmakers are exaggerating how much power the government actually has to drive down drug prices on a large scale. The reality is that any attempt to negotiate with drug makers would be challenging, without any guarantees of an outcome that would make a significant difference to most consumers’ bottom line.advertisement The Clinton campaign declined to provide more details on its plan. A Sanders aide said details would be left to the Centers for Medicare and Medicaid Services, which is part of HHS, and any legislation would just broadly define the federal government’s authority.That could be a problem.“I don’t know of anyone who has thought this through as a realistic policy innovation because it has never been even close to happening,” said John McDonough, a professor at the Harvard School of Public Health and a former aide to Senator Edward M. Kennedy.Still, some Democrats are quietly working through the mechanics of drug price negotiations — aided by the work of researchers who have written about the subject for health care journals.It’s not practical to expect the Centers for Medicare and Medicaid Services to negotiate every drug in the program, a process that would be unwieldy and time-consuming, Democratic health care experts say. It’s better, they say, to focus the effort on the most expensive treatments — and to allow the government to insist that they prove an added value over the drugs the program already covers.The Clinton drug prices plan hints that this is where she would put her focus, saying she would allow Medicare to negotiate prices “notably for high-cost drugs with limited competition.” That’s more in line with the Obama budget, which limited its proposal to biologics and high-cost drugs. The Sanders bill doesn’t suggest any such limits.For drugs where there is more competition, the most likely approach would be to give individual, private drug plans more power to negotiate on their own — because their ability to say “no” is significantly restricted right now.The current Medicare rules require drug plans to cover “all or substantially all” medications under six protected classes. They include drugs that combat depression, tumor growth, schizophrenia, epilepsy, and viruses, as well as those medicines that make it less likely to reject an organ after a transplant.The rule is there because the Medicare agency wanted to make sure the drug plans wouldn’t end up subtly screening out seniors who need those medications. But it also weakened the drug plans’ leverage with pharmaceutical companies — because there are large categories of treatments where they have no real ability to tell price-hiking drug executives to get lost.“To negotiate, you have to have a credible threat of saying no,” said Kevin Outterson, co-director of the health law program at Boston University, who has written about Medicare drug pricing options for the journal Health Affairs. STAT-Harvard poll: Dismayed by drug prices, public supports Democrats’ ideas Tags Bernie Sandersdrug pricesHillary ClintonpolicyPresidential campaign The idea of negotiating with drug makers dates back to the creation of the Medicare prescription drug benefit in 2003, when Republicans — who controlled Congress at the time — wrote a section into the law that banned the Department of Health and Human Services from getting involved in talks over prices. Individual, private drug plans that provide the coverage for Medicare can negotiate — with some significant restrictions.Ever since then, Democrats in Congress have floated proposals that would lift the ban. President Obama called for letting Medicare negotiate the prices of biologics (which are often made from living cells) and high-cost drugs in his budget proposal to Congress last year. And Sanders has introduced a bill that would get rid of the restriction, and says HHS “shall negotiate” drug prices for people with Medicare drug coverage.These proposals have made good political sense. About three-quarters of the public believe the prices of brand-name prescription drugs are unreasonable, according to a poll last year by STAT and the Harvard T.H. Chan School of Public Health. About 7 out of 10 Americans, including two-thirds of Republicans, said Medicare should be able to negotiate lower prices for all prescription drugs. But none of the proposals to empower Medicare to begin negotiations has spelled out how that would work. Related: Related: Nobody knows if candidates’ drug-price plans will actually work One reason for high drug prices: a huge backlog of unapproved generic drugs last_img read more

first_img Newsletters Sign up for Morning Rounds Your daily dose of news in health and medicine. Leave this field empty if you’re human: Siblings and autismBuxbaum, the Mount Sinai researcher, is seeking to enroll hundreds of families with autistic sons but unaffected daughters in a study looking for genetic clues and protective factors. Funded by the Autism Science Foundation, the Autism Sisters Project began last year with the goal of building a big database that other scientists can use. Girls and their families visit the New York lab to give saliva samples for DNA analysis and efforts are underway to expand DNA collection to other sites.Evee Bak, 15, hopes her saliva samples will eventually benefit her older brother Tommy. The suburban Philadelphia siblings are just a year apart. They play in a garage band — Evee on drums, Tommy on guitar and vocals. He’s a masterful musician, but has trouble reading social cues and doing things that come easy to other teens, like shopping alone or using public transportation.“The thing at the forefront of my mind is mostly just taking care of Tommy and making sure he’s happy and healthy,” Evee said.Tommy was diagnosed at age 3, after he stopped using words he’d learned months earlier and showed unusual behavior including repetitively lining up toys instead of playing with them.“He’s a wonderful person and I don’t think that we’d ever want to change him,” said his mother, Erin Lopes. But they’d welcome anything that could help him function as independently as possible “because I think that’s what he really wants, is to be independent.”— Lindsey Tanner A driving game can help young people with autism learn the real thing Is the dramatic rise in autism tapering off? Related: CHICAGO — Think autism and an image of an awkward boy typically emerges. The developmental disorder is at least four times more common in boys, but scientists taking a closer look are finding some gender-based surprises: Many girls with autism have social skills that can mask the condition. And some girls are born without autism despite the same genetic mutations seen in boys with the condition.The gender effect is a hot topic in autism research and one that could lead to new ways of diagnosing and treating a condition that affects at least 1 in 68 US children.Better understanding of gender’s role is key to helping the most people, said Kevin Pelphrey, an autism researcher at George Washington University. “Autism may not be the same thing in boys and girls.”advertisement Related: What science showsThe causes of autism aren’t known but various genetic mutations are thought to play a role and outside factors including older parents and premature birth also have been implicated.Brain imaging suggests there may be an additional explanation for why many girls with autism have more subtle symptoms, Pelphrey said.advertisement HealthGirls and autism: It can be subtle, or absent for some at risk Privacy Policy Making a diagnosisThere’s no autism blood test. It’s diagnosed by observing behavior and some experts say gender-based differences highlight a need to develop different ways to evaluate boys and girls.Autism screening is recommended for all kids at age 18 months and 2 years. But screening tools typically are based on research in autistic boys, said Rachel Loftin, clinical director of an autism center at Rush University Medical Center in Chicago.One widely used screening questionnaire for parents focuses on social deficits seen more often in autistic boys than affected girls. Questions include, “Does your child play make-believe, make eye contact, seek praise, show interest in other children?” Girls with autism, especially mild cases, often don’t show obvious problems in those categories — they’re more likely than affected boys to play pretend with toys rather than lining them up by size or shape. Loftin said they’re also more likely to show concern for another person’s feelings.Government data show that all forms of autism — mild to severe — are more common in boys and that the average age at diagnosis is 4 years in boys and girls. But Loftin said anecdotal evidence suggests a two-year lag time in diagnosis for girls, especially those with mild cases. And she suspects many cases are missed or misdiagnosed. That means a delay in early intensive behavior therapy that is the main treatment for autism.Some girls manage to camouflage symptoms until school pressures to fit in become overwhelming, delaying diagnosis until around age 8 or 9, said Alycia Halladay, chief science officer at the Autism Science Foundation, a nonprofit educational and research-funding group.Prominent autism advocate, professor and author Temple Grandin didn’t fit that mold. She wasn’t fully verbal until age 4. “It was obvious something was drastically wrong with me,” Grandin said. With “1950s parenting” including intense encouragement to develop social skills and other talents, she said she learned to adapt. By Associated Press Oct. 25, 2016 Reprints Autism may affect not just brain but sensory nerves, mouse study suggests A mom’s concernAllison Klein worried about possible autism in her daughter, Jillian, for three years before the little girl was finally diagnosed. Jillian couldn’t tolerate loud noises, grew withdrawn around her preschool classmates and lagged behind their academic progress. She was labeled anxious, not autistic.“She didn’t meet the stereotypical behaviors of no eye contact, no communication, hand flapping,” Klein said. “It was always the hands-off approach” from teachers and doctors.”“They’d say, ‘Let’s wait and see. Give her some time, she’ll grow out of it. She’s just shy,’” Klein recalled. “People dismiss it in girls.”A few months ago, just before Jillian turned 6, Rush University’s Loftin confirmed Klein’s concerns. Jillian has mild autism. Now the family is playing catch-up in getting her needed services. “The surprising thing we are finding is that even in girls who clearly have autism,” brain regions involved in social behavior that are normally affected are less severely impaired, he said.Recent studies on autism-linked genes have found another gender difference.Girls can have the same kinds of genetic mutations seen in boys with autism, “and even need to have twice as many mutations on average to actually manifest with autism,” said Joseph Buxbaum, director of an autism center at Mount Sinai medical school in New York City.Buxbaum is among researchers trying to identify a “protective factor” that may explain how some girls at genetic risk remain unaffected, perhaps a protein or other biological marker that could be turned into a drug or other therapy to treat or even prevent autism. That possibility is likely a long way off, but Pelphrey said this line of research has prompted excitement among autism scientists. Please enter a valid email address. About the Author Reprints Evee Bak (left) talks with her brother Tom Bak at the Seaver Autism Center at Mount Sinai Hospital in New York. Tom has autism but Evee doesn’t. The gender effect is a hot topic in autism research. AP Photo/Seth Wenig Related: Associated Press Tags autismgeneticswomen’s healthlast_img read more

By Jeremy Snyder Feb. 1, 2017 Reprints About the Author Reprints Newsletters Sign up for First Opinion A weekly digest of our opinion column, with insight from industry experts. APStock Tags ethicsfinancepatients Jeremy Snyder The rise of medical crowdfunding raises several ethical issues. As I explore in an article in the Hastings Center Report, these include issues of fraud and misinformation, fairness, perpetuating systemic injustice, efficient use of the funds raised, privacy, and shifting the valuation of health care. I focus here on privacy and equitable access to health care. Other factors, such as the recipient’s physical appearance, social connections, ability to get media attention for the story, and online communication skills are also likely to affect a campaign’s success. If those characteristics are correlated with the recipient’s position in society, then medical crowdfunding will have a tendency to benefit mostly those who are already in a relatively advantaged position.One might say that this inequality shouldn’t matter as long as no one is being hurt by medical crowdfunding. But here, too, there is reason for concern. If the need for medical crowdfunding is created by shortcomings or injustices in the recipient’s health care system — primarily insufficient insurance coverage — then this way of raising money addresses only the symptoms of these problems. That in itself isn’t a concern. But if the popularity of medical crowdfunding shifts attention away from these problems and diverts energy from addressing them, then crowdfunding could delay or prevent reforms that would benefit the vast majority of people who do not use crowdfunding or are less successful with it.There is good reason for this concern. My colleagues and I have shown that medical crowdfunding campaigners largely don’t address the underlying, systemic causes of their need. Instead, crowdfunding sites urge campaigners to present positive, uplifting stories rather than critique their health systems. [email protected] Crowdfunding of medical devices raises money — and questions Customers flocked to this futuristic medical tricorder. Now they’re crying foul PrivacyMedical crowdfunding campaigns typically include many personal details, including the recipient’s name, medical condition, financial situation, and regular updates on his or her health. These details are usually accompanied by photos and videos depicting the recipient with friends and family, or in a hospital room surrounded by medical equipment. Yet we typically assume that that this kind of deeply personal information and imagery is private.advertisement Leave this field empty if you’re human: The takeawayRaising the ethical issues posed by medical crowdfunding doesn’t mean it is a bad endeavor or should be avoided. Instead, it highlights the need to set norms that protect patient privacy, make crowdfunding more accessible regardless of social position, and harness its power as a vehicle for positive social change. One means of doing that may be to encourage more transparent, nonprofit platforms such as Watsi as alternatives to the dominant, for-profit players.Greater awareness of these concerns should help potential campaigners and donors make more informed decisions when considering whether to participate in medical crowdfunding.Jeremy Snyder, PhD, is an associate professor in the Faculty of Health Sciences at Simon Fraser University in British Columbia, Canada. A longer version of this article appeared in the Hastings Center Report. Medical crowdfunding — using social networks and media to raise funds for medical treatment — is growing in popularity and visibility. Recent examples include an American university student seeking $30,000 on YouCaring to help pay for medical expenses related to his cancer treatment and a Canadian family asking for money on GoFundMe to move close to the hospital where their child was being treated after being savagely attacked by several dogs.Given the high cost of medical care and gaps in — or lack of — insurance coverage, it is easy to imagine why an individual or family might resort to crowdfunding, and even easier to understand why it is often viewed as a lifesaver.Crowdfunding websites like CrowdRise, Fundly, Indiegogo, and those mentioned above make it simple for users to promote their requests and update them via social media. The crowdfunding site GivingForward claims that it helped raise $65 million for 50,000 campaigns between its launch in 2008 and 2013. Keep in mind that most of the sites don’t offer the service for free. They typically collect fees ranging from 3 percent of each donation to almost 8 percent (credit card companies collect an additional 2.9 percent); such fees usually aren’t mentioned on a recipient’s donation page.advertisement Related: Please enter a valid email address. @jeremycsnyder Individuals who turn to crowdfunding seem to voluntarily forgo this privacy in order to raise money. Yet many recipients feel that they don’t have an alternative to crowdfunding. Choosing to withhold private information is not an option for crowdfunding campaigners, since they are typically required to use their real names in their campaigns. They are also told that providing and widely sharing photos and detailed information is necessary to reach their crowdfunding goals.Some crowdfunding campaigns are run by a recipient’s parent or by other family members. Sharing another person’s personal information clouds the issue of consent about the public disclosure of private information. If the recipient of the crowdfunding drive is an adult, his or her medical condition may make it impossible to give consent to these disclosures — or may not even be consulted about what information is shared. For children below the age of consent, even well-meaning parents and other family members running fundraising campaigns may not consider the ramifications of these disclosures on the child’s future.Equitable accessMedical crowdfunding could have negative effects on equitable access to health care. The likelihood of a crowdfunding campaign reaching its funding goal may depend in part on factors such as the kind of treatment needed and the reason for the campaign. Differentiation by the popularity of the medical cause or sympathy for the recipient goes against principles of treating patients according to the severity of their medical needs or aiming for the greatest good in treatment. In other words, funding according to popularity runs against evidence-based attempts to use our health care funding as fairly and efficiently as possible. First OpinionEthical issues complicate the benefits of medical crowdfunding Privacy Policy Related: read more

first_imgPharma 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. Damian Garde The 5 most overpaid pharma CEOs in the world Log In | Learn More Tags financepharmaceuticalsSTAT ListsSTAT+ Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED By Damian Garde May 16, 2017 Reprints What’s included? GET STARTED What is it? About the Author Reprints @damiangarde 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. National Biotech Reporter Damian covers biotech, is a co-writer of The Readout newsletter, and a co-host of “The Readout LOUD” podcast. There’s no shortage of ways to rank pharma CEOs: Drug sales. Corporate profits. Even haircuts. Here at STAT, we chose to look at it from a shareholder’s perspective.We calculated shareholder returns over the past three years at the 25 biggest drug companies in the world. Then we compared that with CEO compensation. Five outliers popped out: chief executives who got raises well out of step with what they delivered to investors. [email protected] last_img read more

first_img Judge invalidates Allergan patents and criticizes deal with the Mohawks This sham would hurt thousands of American patients who tell us they are forgoing other medications and even food to pay for Restasis because there is no cheaper generic. They are the real victims.It’s people like Joseph Landi of Boca Raton, Fla. “I’m a retired police officer,” he wrote to Patients For Affordable Drugs, an organization I founded. “My doctor prescribed Restasis for chronic dry eye. I expect to spend at least $1,000 this year for Restasis and there is no cheaper generic. I have had to stop taking other drugs I need to pay for Restasis.”I understand his concerns. As a patient living with an incurable blood cancer who relies on very expensive drugs to stay alive, I want and need the timely introduction of less expensive generics. And I am appalled by the things that pharmaceutical companies will do to prevent generics from entering the market.Although Allergan says it will appeal Judge Bryson’s ruling, in the meantime the inter partes review will go forward. I hope the judge in that forum will deny the Saint Regis Mohawk tribe’s motion for dismissal under sovereign immunity. What would be better is for Congress to shut the door to this tactic once and for all.If we allow big pharmaceutical companies to distract the media and policymakers from the real victims here, thousands of people like Joseph Landi who are struggling to pay for this drug will suffer and that will bring shame on all of us.David Mitchell is the founder and president of Patients For Affordable Drugs, a nonprofit organization that does not accept money from any company or organization that profits from the development and distribution of prescription drugs. Allergan, a multibillion-dollar drug corporation, is attempting to perpetrate a fraud on the American people that would make Bernie Madoff blush — even as it casts itself as a victim.Allergan makes several products, including Restasis, a very expensive brand-name drug that people with dry eye and related conditions take to increase tear production. Failure to treat this condition can impair vision and even lead to blindness.Allergan is using an unprecedented legal ploy to keep a cheaper generic of Restasis from coming to market: transferring its patent rights for Restasis to the Saint Regis Mohawk tribe in upstate New York. By doing so, it aims to sidestep what’s called inter partes review, a type of patent challenge that is easier and faster to file than a lawsuit. As a sovereign tribal government, the Saint Regis Mohawk tribe claims immunity in inter partes review proceedings.advertisement In a ruling last week, federal judge William Bryson saw through the ruse. He not only invalidated several Restasis patents, but he also rebuked Allergan. “The Court has serious concerns about the legitimacy of the tactic that Allergan and the Tribe have employed,” he wrote in his decision. “The essence of the matter is this: Allergan purports to have sold the patents to the Tribe, but in reality it has paid the Tribe to allow Allergan to purchase — or perhaps more precisely, to rent — the Tribe’s sovereign immunity in order to defeat the pending IPR proceedings. … What Allergan seeks is the right to continue to enjoy the considerable benefits of the U.S. patent system without accepting the limits that Congress has placed on those benefits through the administrative mechanism for canceling invalid patents.”As Judge Bryson pointed out, Congress wrote the America Invents Act specifically to create two processes to challenge patents. And unless a challenge to the Supreme Court reverses the act, it is the law of the land. Yet, deeming the law unfair to them, Allergan and its allies claim the right as victims to circumvent it.Let’s remember who these self-proclaimed “victims” are: Allergan is a highly profitable Irish drug corporation that garners more than $1.5 billion in revenue from Restasis. Its CEO was paid $62 million from 2014 to 2016. It is the same company that participated in an evasive legal maneuver last year in an attempt to avoid paying U.S. taxes. Joining in support of Allergan are the Pharmaceutical Research and Manufacturers of America and the Biotechnology Innovation Organization, trade associations that spent almost $20 million lobbying Congress last year. [email protected] Related: Congress created the inter partes review as part of the bipartisan Leahy-Smith America Invents Act of 2011 to more efficiently address patent challenges using expert panels at the U.S. Patent and Trademark Office. It is an alternative to costly litigation in federal court. Allergan has stated unabashedly that it transferred the patent to defeat an inter partes review. The company said that it took this approach because the law is unfair. The company has whined about double jeopardy because patents can be challenged two ways — in federal court and under inter partes review.advertisement By David Mitchell Oct. 25, 2017 Reprints Related: @DavidP4AD Tags courtsdrug pricingfinancepharmaceuticlas About the Author Reprints David Mitchell Allergan’s deal with the Mohawks raises troubling questions about the future of generics First OpinionAllergan invokes the victim defense to protect a brand-name drug from a generic challenge Chris Carlson/APlast_img read more

first_img Related: The FDA’s announcement last week that it approved artificial intelligence software that can identify diabetic retinopathy, a common eye disease, without the need for an eye specialist likely shook some doctors already concerned about this new technology. I don’t think they have anything to worry about.Artificial intelligence, sometimes called AI, is not a dramatic and revolutionary development in the history of medicine. It’s but the latest in a long line of breakthroughs that have made it possible for caregivers to better diagnose and treat illness. We should be wary of the hype surrounding this advance, which is leading to broad misconceptions that AI will replace doctors. What it will actually do is put a premium on physicians’ knowledge and decision-making skills.The history of medicine during the last two centuries should be seen as the development of ever more precise tools that help doctors narrow the range of possible causes for their patients’ symptoms. One of the great breakthroughs occurred in 1816 when René Laennec used a tightly rolled a sheet of paper to listen to a woman’s heart. This stethoscope helped launch a new era in medicine that placed less emphasis on patients’ descriptions of their symptoms and more on the search for clues within their bodies.advertisement Since then, the development of a dazzling array of increasingly precise diagnostic tools — from blood tests and X-rays to EKGs, CT scans, and gene sequencing — has given doctors a much more accurate sense of the biological and chemical roots of disease. Tags educationmedical technologyphysicians Two women try out René Laennec’s third-model stethoscope, made in the early 1800s, at the Smithsonian Institute circa 1955. Orlando /Three Lions/Getty Images Related: FDA approves first AI software that can identify disease, no specialists needed Artificial intelligence is coming to medicine — don’t be afraid First OpinionArtificial intelligence will put a premium on physicians’ knowledge and decision-making skills center_img In fact, during the last few decades technology has flipped the information problem upside down. Instead of having too little information, caregivers today have far more than they can process on their own.This is the great promise of artificial intelligence: to train machines to comb through petabytes of data on their own to find patterns that would elude human caregivers. It is already paying dividends. Stanford researchers used a deep-learning algorithm to identify cancerous spots in medical images. An Israeli-based medical analytics company recently announced it had developed an algorithm capable of detecting intracranial hemorrhages, which are often missed and contribute to nearly 1 million deaths worldwide each year. And researchers at my school, the University of Michigan, have produced an algorithm that analyzes more than 4,000 distinct variables to predict who might be susceptible to contracting a dangerous intestinal infection called Clostridium difficile, or C. diff.These and other promising breakthroughs have led some to suggest that machines may supplant doctors, just as autonomous vehicles might someday replace drivers. Such thinking puts the cart before the horse. Like the medical technologies that have come before it, artificial intelligence is another tool that will make the knowledge, skill, and judgment of physicians even more central to quality care. By Marschall S. Runge April 19, 2018 Reprints The development of medical charts in the early 20th century gathered a patient’s information into a single file. These charts allowed doctors to better track the effectiveness of their treatments. They also helped transform medicine from an art based on personal knowledge and intuition into a science based on objective evidence. The development of electronic health records during the last few decades has vastly increased our ability to gather and analyze patient data.advertisement The human body is such a complex and dynamic entity — each one unique in its own way — that medicine will never become a mathematical problem in which data can be crunched to produce the single right answer. It will always involve a process of elimination that allows the caregiver to focus on the most likely cause of illness and determine the most effective treatments from a range of options.Artificial intelligence will undoubtedly inform and improve this decision making process — guided by physicians. The great challenge going forward is in recognizing and nurturing this irreplaceable human element, to train doctors to work with machines without becoming too reliant on them, and to never forget the centrality of the doctor-patient relationship and the importance of the human touch. Just as the stethoscope was only as useful as Laennec’s ability to assess what he was hearing in his patient’s chest, the success of artificial intelligence will depend largely on the ability of physicians to interpret and apply its findings.Dr. Abraham Verghese, a graceful writer and professor at the Stanford University School of Medicine, put it best when he observed, “The way here is not to think technology versus human, but to ask how they come together where the sum can be greater than the parts for an equitable, inclusive, human and humane care and practice in medicine.”Marschall S. Runge, M.D., is the executive vice president for medical affairs at the University of Michigan and dean of the University of Michigan Medical School. He receives funds from Eli Lilly for his work as a member of its board of directors. Marschall S. Runge @umichmedicine About the Author Reprintslast_img read more

first_img Alex Hogan/STAT By Ed Silverman May 18, 2018 Reprints [email protected] Tags drug pricesLitigationpatentspharmaceuticalspharmalittleSTAT+ Ed Silverman GET STARTED Pharmalot @Pharmalot 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 center_img 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. And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. And our agenda is ambitious. We hope to noodle around the Pharmalot grounds, visit the Pharmalot ancestors and take in another installment of our ‘Let’s-see-them-before-they-die‘ concert series. And what about you? This is, as we regularly remind you, a fine time to enjoy the great outdoors. Perhaps, you could catch up on your reading or make time for someone special. Or you could tune out the real world and watch the Royal Wedding. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon…Amgen (AMGN) will charge $6,900 a year for a new drug that can spare migraine sufferers a few headaches each month, a price well below Wall Street expectations as the company hopes to avoid payer backlash that has hamstrung recent drug launches, STAT reports. The drug, called Aimovig, is meant for patients who experience at least four migraines per month. There are roughly 24 million patients in the U.S. who would be candidates for treatment. The Institute for Clinical and Economic R, a nonprofit that assesses the value of medicines, pegged cost effectiveness at $8,500. What is it? About the Author Reprints Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. What’s included? Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Pharmalittle: Amgen migraine drug costs less than expected; J&J halts development on Alzheimer’s drug last_img read more

first_img Robin Gelburd [email protected] I’ve put my family on a health insurance experiment. It’s been a challenge To make wise decisions about their health, consumers need to know how much their health care costs. That’s the growing consensus from all sides of the political spectrum. But because publishing information about health care costs and quality in the same way it is published for books or appliances is a relatively new paradigm, we haven’t really known how — or even if — this kind of transparent information affects consumer behavior.My organization, FAIR Health, recently launched a health care price and quality website, YouCanPlanForThis.org. It is powered by our repository of private health care claims data, the nation’s largest. Other price and quality transparency websites exist, but ours is unique both because the data underlying it are more extensive and because our nonprofit organization is known for neutrality. Aimed at increasing the level of transparency available to consumers, the site provides us with an opportunity to observe the impact of price transparency on consumer behavior patterns.Using website analytics and an embedded website survey, we have determined what types of consumers are using YouCanPlanForThis, how they are using it, and whether their use affects their ability to plan for and manage health care costs. The site has become a living laboratory for researchers and policy makers to better understand how consumers use price transparency tools.advertisement Newsletters Sign up for First Opinion A weekly digest of our opinion column, with insight from industry experts. Related: I’m the perfect person to price shop for an operation. But the process went terribly Does price transparency influence consumers’ actions?As consumers shoulder ever-larger portions of their health care costs, whether due to high-deductible health plans or changing reimbursement and cost-sharing models, they increasingly need price information to guide their health care decisions. Nearly 60 percent of our survey respondents indicated that the website improved their ability to make health care decisions and navigate the health care system. A sampling of consumer feedback highlights the value of access to price information before and after receiving care:“It gave me a better idea about what a fair price was”“My finances are limited and making a good choice means having all data/information that I can to do what is best for me and my family”“Figured out if the claim payment was correct”“Decided to stay in network”“Informative on costs to be able to have conversation with health care provider”“Gave me insight into how to budget for upcoming health and dental costs” Please enter a valid email address. By Robin Gelburd June 12, 2018 Reprints First OpinionWebsite offers a living laboratory for examining health care prices and quality About the Author Reprints YouCanPlanForThis.org is a health care price and quality website launched by FAIR Health. Screen Capture via FAIRHealth Related: Privacy Policy @FAIRHealth Nearly two-thirds of YouCanPlanForThis users are female, confirming the general understanding that women are traditionally the gatekeepers of family health. And about half of the site’s visitors are age 55 and older. This could be because older individuals are more frequent users of the health care system, or that baby boomers are caregivers to both their parents and children, and thus need to be more mindful of health care planning.The average time consumers spend on the site is four or more minutes, which is higher than the industry standard and suggests substantial engagement. And nearly 75 percent of users are accessing the information on their mobile devices, highlighting the fact that all age groups are using mobile devices, at a higher rate than desktops, to access information online.How are consumers using the site?Our survey showed that 75 percent of users said they visited the site to learn about a medical or dental cost where they lived. Some said they intended to use the estimate to plan for a family member or relative; others to negotiate prices with a doctor or hospital; and some to decide whether to obtain a service or procedure. Seventy-eight percent of respondents said they used the cost estimate in the way they had planned, such as planning for the cost of services from a provider who didn’t take their insurance. This suggests that the site is not only providing information to consumers but is providing real help in their efforts to plan for and manage health care costs.Among the most common medical search terms were MRI, CT scan, colonoscopy, physical therapy, emergency room, and ultrasound. The top dental terms searched were root canal, crown, implant, orthodontic, and bridge. What types of consumers are using the site?Most of the more than 50,000 visitors who have used the site since it was launched in September 2017 have health insurance. Of these, 29 percent were looking up costs for providers who don’t take their insurance, while 26 percent were looking up costs for providers who do take their insurance. Only 15 percent were uninsured, while 30 percent weren’t sure whether they were insured or what kind of costs they wanted to look up. Tags insurancepatientsphysicians Leave this field empty if you’re human: Skeptics say that few people use price transparency tools to manage health care costs. Our analytics and survey counter that claim. At least on YouCanPlanForThis, consumers use price information to plan for and manage their health care costs, and moreover are using it for the reason they intended.Trends we did not anticipate, such as that the majority of users are over 55 and are accessing the site from mobile devices, point to the importance of ongoing empirical research into the effect of price transparency tools on consumer behavior.Because YouCanPlanForThis is a living laboratory, it will take some more time to sift through the results of this social experiment and understand more particulars about how consumers use price transparency tools. We expect that it will continue to show that consumers derive value from such tools and use them to bring greater clarity and precision to their health care decisions.Robin Gelburd, J.D., is the president of FAIR Health, a national, independent nonprofit organization dedicated to bringing transparency to health care costs and health insurance information. Those numbers show that the site can be useful for a broad array of consumers. Say your provider doesn’t take your insurance. You can discover the usual cost in your area of the procedure you need. That can help you budget for the cost, or decide if you want to choose a provider who does take your insurance. The site can also be used to compare a provider’s price to the other prices listed on the site. That can help with negotiating the cost of a procedure. For uninsured individuals who have to pay the full price of medical services, knowing the usual cost can help them plan and also evaluate the value of insurance.advertisementlast_img read more

first_img @adamfeuerstein About the Author Reprints Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Senior Writer, Biotech Adam is STAT’s national biotech columnist, reporting on the intersection of biotech and Wall Street. He’s also a co-host of “The Readout LOUD” podcast. [email protected] Biotech Tags biotechnologydrug developmentSTAT+ 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. What’s included?center_img Surprise! Bluebird Bio’s beta thalassemia gene therapy is already under review in Europe Bluebird Bio (BLUE) is surprising investors Friday with some unexpectedly good news out of Europe.A marketing application covering the Cambridge, Mass., biotech’s gene therapy for beta thalassemia was accepted for review by European regulators, Bluebird announced. GET STARTED By Adam Feuerstein Oct. 5, 2018 Reprints Log In | Learn More Bluebird CEO Nick Leschly Wendy Maeda/The Boston Globe 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. Adam Feuersteinlast_img read more