Pharmalot, Pharmalittle: J&J to pay $72m in damages, Valeant may restate financial results

first_img Alex Hogan/STAT Seven big drug makers — including Pfizer, Eli Lilly, AbbVie, and AstraZeneca — joined a consortium to streamline and accelerate the development of new treatments for Parkinson’s disease, Pharma Times says.An experimental drug-infused ring that is inserted in the vagina once a month cut the risk of HIV infection by more than half among women who used the device consistently, Reuters reports, citing a new study.The vaccine to combat human papillomavirus, or HPV, has reduced the prevalence in teenage girls by almost two-thirds, The New York Times writes, citing new research.An ibuprofen patch capable of delivering the medicine through the skin to the site of pain, and at a consistent dose for up to 24 hours, has been developed by UK researchers, Reuters says.The UK’s National Institute for Health and Care Excellence issued final guidelines recommending Bristol-Myers Squibb’s Opdivo as a monotherapy for adult patients with advanced melanoma, Pharma Times reports. PharmalotPharmalot, Pharmalittle: J&J to pay $72m in damages, Valeant may restate financial results @Pharmalot Ed Silverman [email protected] Good morning, everyone, and how are you today? We are just fine, thank you. Although gray skies are enveloping the Pharmalot campus, our spirits remain sunny. After all, as the Morning Mayor taught us: “Every brand new day should be unwrapped like a precious gift.” So go ahead and tug on the ribbon. While you do, we will indulge with another cup of needed stimulation. Meanwhile, here are some items of interest. Hope your day goes well …Valeant Pharmaceuticals will probably need to restate some of its earlier financial results based on an internal investigation, The Wall Street Journal reports. The potential revisions concern revenue recorded when medicines were shipped to Philidor Rx Services, a mail-order pharmacy during late 2014 and early 2015. The drug maker believes about $58 million of revenue recognized in late 2014 should have instead been booked in 2015. ​Johnson & Johnson must pay $72 million in damages to the family of a woman who blamed her fatal ovarian cancer on talcum powder sold by the health care giant, Bloomberg News reports. This was the first state-court case to go to trial over claims that the company knew decades ago that its talc-based products could cause cancer, but, nonetheless, failed to warn consumers.advertisementcenter_img About the Author Reprints By Ed Silverman Feb. 23, 2016 Reprints More than two dozen state and city health directors filed a petition with the Food and Drug Administration to label prescription painkillers and sedatives with a black box warning because the combination of the drugs can cause fatal overdoses, STAT tells us. The move comes amid mounting concerns over growing painkiller abuse, which the Centers for Disease Control has called an epidemic.The US Senate voted overwhelmingly to end debate on whether to confirm Dr. Robert Califf as the next FDA commissioner, setting up a final confirmation vote most likely later this week, BioCentury tells us.advertisement Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Tags cancerFDAJohnson & JohnsonlegalpharmaceuticalspolicyValeant Pharmaceuticalslast_img read more

Colombia plans to proceed with price cut on Novartis cancer drug

first_img Related: @Pharmalot Ed Silverman About the Author Reprints For its part, the pharmaceutical industry has argued that compulsory licenses should be reserved for public health emergencies and as a measure of last resort. Fearing that the moves by the Colombian government might embolden other countries to quickly take similar steps, the industry turned to Washington for backing.Last spring, staffers from both the US Senate Finance Committee and the US Trade Representative’s office met with Colombian embassy officials in Washington D.C., and suggested that Washington might withdraw support for a free trade agreement and $450 million in backing for a peace initiative between the Colombian government and Marxist rebels.The move, however, created a mini-backlash among some Democratic lawmakers and appeared to have hardened the resolve of Gaviria and his health ministry. In June, he signaled he would move ahead with a unilateral price reduction, although he has not ruled out the possibility of issuing a compulsory license, either.“We condemn the behavior of Big Pharma, their gremial representatives, and their supporters’ governments (effort) to press the government of Colombia in order to stop a sovereign power from …  protect(ing) the fundamental right of (its) people and the financial sustainability of the health system,” three patient groups — Mision Salud, Fundacion Ifarma, and Cimun — said in a statement.A Novartis spokesman sent us a note saying the company believes the declaration “was issued improperly and creates an unwarranted and damaging precedent that could apply to any patent-covered innovations, not just pharmaceuticals. Declarations can be important and legitimate tools in exceptional circumstances, such as when public health is at immediate risk and cannot be addressed by any other means. This is not the case with Gleevec. Novartis, Colombia face off over cancer drug cost The episode drew particular notice, though, after Gaviria initially earlier this year considered pursuing a compulsory license. This would allow the Colombian government to sidestep the Novartis patent on Gleevec so that a lower-cost version could be produced. Countries can issue such licenses under the terms of a World Trade Organization agreement. Leave this field empty if you’re human: “Currently all patients in Colombia who need Glivec have access to it. There is no public health crisis, no shortages, and no evidence of other access issues. The government exerts price controls … and has reduced the price twice in the last three years,” he continued. He added generic versions that do not infringe the patent are available. However, government officials previously noted that Novartis has indicated any trace of its own drug appearing in a generic would be considered a patent violation, suggesting litigation might ensue.In a statement, Brian Toohey, a senior vice president for international issues at the Pharmaceutical Research and Manufacturers of America trade group said “the Colombian Government’s actions are without merit … Ad hoc price cuts are not effective or sustainable ways to improve access or achieve other critical public health goals. Pricing systems should be based on transparent rules and fair processes that provide business certainty for pharmaceutical innovators.” By Ed Silverman Sept. 16, 2016 Reprints After weeks of deliberations, the Colombia health minister is proceeding with plans to unilaterally lower the price of a Novartis cancer drug that has become the latest symbol of the battle between access to medicines and intellectual property rights.The amount of the reduction has not been announced, but Colombia media reported Health Minister Alejandro Gaviria may drop the price for Gleevec by up to 45 percent. Patient advocacy groups note that the annual cost of the drug is roughly $15,000, compared with per capita gross national income of about $8,000. This would amount to “significant savings for the whole health system,” the patient groups said.[UPDATE: Gaviria tells us that the health ministry planned to set the new price this month, but has just received a formal petition from the US Trade Representative seeking 30 days to submit. “We are studying the petition. In any case, we don’t want to put this off much more,” he tells us.]advertisement Please enter a valid email address. Tags cancerColombiaNovartispolicy Privacy Policy PharmalotColombia plans to proceed with price cut on Novartis cancer drug [email protected] Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Colombia Health Minister Alejandro Gaviria, center. Matilde Campodonico/AP In explaining his actions, Gaviria has argued that issuing a so-called Declaration of Public Interest, which allows the government to take various steps to reduce the price of a medicine, would be justified since the cost for Gleevec is out of reach for some citizens. The government began exploring this step after talks with Novartis failed to yield a lower price.His decision, which came after the government rejected appeals by the drug maker, is the latest development in a closely watched struggle. Patient groups see it as a test case for using legal rights to ensure needed medicines are accessible, while the pharmaceutical industry views it as a potentially precedent-setting case in which a middle-income country uses trade rules to lower its drug costs.advertisement Newsletters Sign up for Pharmalot Your daily update on the drug industry.last_img read more

Watchdog says EPA delayed Flint emergency order

first_img The Flint Water Plant water tower is seen in Flint, Mich. The inspector general for the EPA says the agency delayed issuing an emergency order to protect Flint residents from lead-contaminated water. Carlos Osorio/AP WASHINGTON — The Environmental Protection Agency had sufficient authority and information to issue an emergency order to protect residents of Flint, Mich., from lead-contaminated water as early as June 2015 — seven months before it declared an emergency, the EPA’s inspector general said Thursday.The Flint crisis should have generated “a greater sense of urgency” at the agency to “intervene when the safety of drinking water is compromised,” Inspector General Arthur Elkins said in an interim report.Flint’s drinking water became tainted when the city began drawing from the Flint River in April 2014 to save money. The impoverished city of 100,000 north of Detroit was under state control at the time. Regulators failed to ensure water was treated properly and lead from aging pipes leached into the water supply.advertisement Watchdog says EPA delayed Flint emergency order A panel appointed by Michigan Governor Rick Snyder concluded that the state is “fundamentally accountable” for the lead crisis because of decisions made by state environmental regulators and state-appointed emergency managers who controlled the city.advertisement About the Author Reprints Federal, state, and local officials have argued over who’s to blame as the crisis continues to force residents to drink bottled or filtered water. Doctors have detected elevated levels of lead in hundreds of children. Uncertainty haunts parents of Flint, as every rash, every tantrum raises alarms Related:center_img New CDC data reveal scope of the Flint water crisis The director of the EPA’s Midwest regional office stepped down Feb. 1 amid withering criticism that the agency failed to act sooner to address lead contamination in the predominantly African-American city.The official, Susan Hedman, denied wrongdoing, but said she was leaving to avoid becoming a distraction.In a memo from June 2015, Miguel Del Toral, a scientist in the EPA’s Midwest office, had warned of dangerously high levels of lead. He later criticized the agency for not taking swift action.Representative Jason Chaffetz, R-Utah, chairman of the House Oversight and Government Reform Committee, said Hedman “dismissed” Del Toral’s warnings without good cause.“You screwed up and you ruined people’s lives,” Chaffetz told Hedman at a March 15 hearing.— Matthew Daly By Associated Press Oct. 20, 2016 Reprints Associated Press Even so, Snyder and other Republicans have faulted the EPA for a slow response.At a congressional hearing this past spring, Snyder blamed career bureaucrats in Washington and Michigan for the crisis, while apologizing for not acting sooner to resolve it.The report by the inspector general says officials at the EPA’s Midwest region did not issue an emergency order because they concluded that actions taken by the state prevented the EPA from doing so. The report calls that interpretation incorrect and says that under federal law, when state actions are deemed insufficient, “the EPA can and should proceed with an (emergency) order” aimed at “protecting the public in a timely manner.”Without EPA intervention, “the conditions in Flint persisted, and the state continued to delay taking action to require corrosion control or provide alternative drinking water supplies,” the report said.Michigan officials declared a public health emergency in October 2015; the EPA declared an emergency three months later.EPA Administrator Gina McCarthy has acknowledged that her agency should have been more aggressive in testing the water and requiring changes, but said officials “couldn’t get a straight answer” from the state about what was being done in Flint. McCarthy has refused requests by GOP lawmakers to apologize.“It was not the EPA at the helm when this happened,” she said. Related:last_img read more

How mice are helping personalize cancer treatment

first_img Humanized mice will increase the success rate of drugs in human trials, decrease the cost of bringing new medicines to market, and expand the arsenal of weapons that doctors can deploy against cancer. They will also give doctors better information about which weapons to choose when faced with a particular foe, increasing patients’ chances of beating their cancer.The national cancer moonshot has recognized the promise of immunotherapy and the challenges it faces, making it one of 10 priorities for advancement over the next five years. “Current immunotherapy treatments represent only the tip of the iceberg of what is possible,” the moonshot’s blue ribbon panel wrote in September, “and human studies using newly developed, cutting-edge technologies are key to further advances.”There is no doubt that human studies will be essential to immunotherapy’s progress. But mice also deserve a place in the immunotherapy research agenda.Aidan Synnott is the executive director of discovery oncology at Charles River Laboratories, where he oversees the company’s oncology discovery services sites. Related: By Aidan Synnott Dec. 6, 2016 Reprints Tags cancerprecision medicine Beware the hype: Top scientists cautious about fighting cancer with immunotherapy First OpinionHow mice are helping personalize cancer treatment @criverlabs Immunotherapy represents one of the next frontiers of treating cancer. First used against lymphoma and breast cancer, immunotherapy is now being used and tested against a wide range of other cancer types.Yet plenty of obstacles must still be overcome before immunotherapy stands with chemotherapy, radiotherapy, and surgery as a major pillar of cancer treatment. We need to figure out why immunotherapy is effective in only 20 percent to 30 percent of patients. We need to understand why procedures like CAR-T therapy, which reprograms an individual’s own immune cells to track down and kill cancer, can cause serious and occasionally fatal side effects. And we need ways to determine which combinations of immunotherapy and chemotherapy or radiotherapy are best for each individual with cancer.Complicating these issues is the fact the immune system and cancer are both highly specific to each individual. In fact, two people with seemingly similar tumors growing in the same part of the body can experience vastly different outcomes from treatment.advertisement Related:center_img Xenograft mice are mice into which a human tumor has been implanted. These mice have been a valuable tool in cancer research for more than a decade. But their usefulness in immunotherapy is limited. For a human tumor to take root and grow in a mouse, the animal’s immune system must be disabled so it won’t recognize the implanted tumor as foreign and reject it. While that works well for testing chemotherapies, an immunotherapy can’t be tested in a mouse with no immune system.Fortunately, researchers have developed ways to introduce components of the human immune system into mice genetically modified to have no immune system of their own. These so-called humanized mice don’t reject a human tumor and, with an immune system in place, will respond to immunotherapy.When implanted with a tumor removed from a patient, humanized mice are in many ways stand-ins for that person. Called patient-derived xenografts, these animals may prove more realistic models than mice implanted with the standardized, dish-grown cancer cells that have traditionally been used for clinical research.In theory, humanized mice could be used to deliver truly personalized cancer care. Every patient could one day have his or her tumor implanted in several humanized mice, which would then be treated with various combinations of chemotherapy and immunotherapy to determine the most effective one.In practice, though, most patients won’t have the time or money to follow such a strategy. Instead, researchers are creating hundreds of tumor lines in humanized mice that capture as much of the genetic diversity of human cancers as possible. Because a cancer’s genes are the key to determining whether it will respond to a particular drug, testing a single treatment or combination of treatments on these mice should provide valuable data about what drugs will work for which patients. It heralds an era of truly precision-driven tools.My company, Charles River Laboratories, is already testing cancer immunotherapies against tumors from more than 550 patients that have been transplanted into lines of humanized mice. These studies will let us see subtle differences in effectiveness, side effects, and dose responses that are caused by the different mutations underlying these tumors and how they interact with the human immune system. They will help us refine CAR-T therapy and other approaches that rely on the immune system and identify genetic markers that indicate a cancer’s susceptibility to a particular treatment. A mouse carrying a cancer patient’s tumor graft under its skin is displayed in a Champions Oncology lab in Baltimore. Patrick Semansky/AP For cancer patients, newest treatments force the ultimate decision, with no room for error Aidan Synnott [email protected] One of the best ways to explore these differences is to study them in mice.Mice sometimes get blamed for disappointments in cancer research, such as when treatments that were promising in mouse studies do poorly in clinical trials. However, as we learn more about the complex interactions between cancer and the immune system, the need has grown for simple models that allow research into a limited set of factors in a controlled environment. Studies in mice can be a valuable predictor of clinical success as long as mouse models evolve with the science.advertisement About the Author Reprintslast_img read more

Pharmalot, Pharmalittle: Johnson & Johnson to publish drug price hikes

first_img Alex Hogan/STAT 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. Pharmalot, Pharmalittle: Johnson & Johnson to publish drug price hikes About the Author Reprints Ed Silverman Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED GET STARTED [email protected] @Pharmalot Pharmalot center_img Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Tags drug pricingfinancepharmaceuticalsSTAT+ What is it? By Ed Silverman Jan. 10, 2017 Reprints Hello, everyone, and how are you today? We are just fine, thank you, despite daunting weather that altered travel plans. Nonetheless, we managed to arrive at the JP Morgan health care fest, albeit not as soon as we hoped, and plan to scurry about meeting interesting people. As we indicated previously, this will call for sporadic posting. Nonetheless, we have assembled the usual menu of tidbits. We will now search for a cup of stimulation. Have a grand day and do keep in touch …Johnson & Johnson is set to issue a report next month outlining how much it has raised US prices for its prescription drugs, the Wall Street Journal writes. The report will provide the average increase in list prices, as well as average prices after the discounts given by the health care giant. But J&J is not pledging to hold price hikes to single-digit increases, because the company maintains it already does so. 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. Log In | Learn More What’s included?last_img read more

Tinkering with Medicaid is a tricky task

first_img Medicaid is a highly complex program that provides vital care for a broad array of individuals. There are no easy solutions when it comes to reducing its costs. Changing Medicaid, just like reforming health care, is at best an incremental process, particularly when one considers the new populations now covered by the program as a result of the ACA, such as families in which an adult is employed but in a lower-income job.advertisement By Gerard Vitti Feb. 10, 2017 Reprints Want a glimpse into the possible future of Medicaid? Head to Indiana In Iowa, financial pain follows Trump-style Medicaid reforms Gerard Vitti [email protected] Related: APStock President Donald Trump’s administration has made clear its intention to remake Medicaid, the federal-state program that provides health care to lower-income families and individuals, seniors, and those with disabilities. It won’t be easy.Medicaid was dramatically expanded under the Affordable Care Act, which the new administration has begun to phase out. The growth in the number of Americans covered by Medicaid (and the related Children’s Health Insurance Plan) — a 30 percent increase from before the ACA to today — and concerns over long-term funding have drawn the ire of some elected officials. In fact, 19 states to date have declined the opportunity to expand their Medicaid programs under the ACA, fearing a runaway budget train.A solution to the Medicaid cost quandary favored by Trump, Vice President Mike Pence, and Seema Verma, the incoming administrator of the Centers for Medicare and Medicaid Services, is a block grant approach designed to limit funding while providing states with more flexibility.advertisementcenter_img Related: About the Author Reprints When the federal government provides a Medicaid block grant, it gives a state a fixed sum and the state must figure out how to cover all of its Medicaid members with that allotment. Currently, states share the cost of Medicaid with the federal government. Poorer states pay less than richer states. In Mississippi, for instance, the federal government pays about 75 percent of the cost of Medicaid, compared to 50 percent in Massachusetts. Tags MedicaidWhite House A majority of those covered by Medicaid are already in managed care. Many people on Medicaid are on managed care plans, in which case Medicaid pays a fixed fee to a health plan and the plan provides all of the care the member needs, even if the cost of care exceeds the Medicaid payment. That limits how much additional savings states can capture because they are already controlling risk by delegating it, in essence, to health plans.In most states, the federal match is the largest source of revenue. The federal government covers between half and 90 percent of the cost of Medicaid. In many states it is the largest single source of revenue from the federal government. Capping those dollars means limiting a critical revenue source for states.It is indispensable to families with severely disabled children. Medicaid provides health coverage for children with significant disabilities regardless of their parents’ income. This can often mean the difference between financial survival and insolvency for many families that have a child with a disability. If Medicaid doesn’t cover these families, the costs bubble up elsewhere in our health care system. The result will be more bad debt and bankruptcies.There are ways to do things better in any government program, including Medicaid. Every opportunity make the program more efficient should be explored.At the same time, it’s important to keep in mind the remarkable complexity and vital nature of this government program. There is no new material here: Medicaid has been scrutinized for decades by academics, think tanks, government agencies, and private health care entities. In fact, entire organizations, like the Massachusetts Medicaid Policy Institute, exist just to study Medicaid.Since Medicaid touches so many American lives, all of us should wish the administration well as it tries to reimagine Medicaid. Trump, Price, Verma, and their colleagues must be fully cognizant that there are no easy answers and that changes made to the program will have downstream effects on both our health care system and our economy.Gerard A. Vitti is the founder and CEO of Healthcare Financial Inc., a company that helps individuals obtain health care benefits. It has often been said that there are two ways to lower Medicaid costs: reduce eligibility to the program or cut the services provided. Neither are attractive options. Turning the program into block grants firmly delegates decisions on that dilemma to the states.Here are five things the Trump administration must know about Medicaid before it proceeds with any change:It’s about more than poor people. Medicaid has become an essential program for many working families. Eligibility guidelines are set by each state, with the income eligibility ranging quite dramatically. Some states, like Alabama, cover children up to 141 percent of the poverty line while others cover them up to more than 300 percent of the poverty line. In Massachusetts, where I live and work, a family of four earning approximately $48,000 can qualify for Medicaid, and more than 1 in 4 Massachusetts residents is on Medicaid. That means almost everyone living in the state has a family member, close friend, neighbor, or coworker covered by the program. Those Medicaid-covered individuals represent a powerful constituency.A minority of members comprise a majority of the cost. According to the Kaiser Family Foundation, in 2011 more than half of the program’s expenses went to pay for just 5 percent of Medicaid enrollees. Nationally, the elderly and people with disabilities account for just 21 percent of those covered by Medicaid but 48 percent of Medicaid spending. For this population, nursing home care is a major driver of Medicaid costs. Those numbers are significant because any reduction in the covered population that is not elderly or disabled will yield a smaller share of savings. First OpinionTinkering with Medicaid is a tricky task last_img read more

It’s time to get serious about the safety of medical devices

first_imgPolitics It’s time to get serious about the safety of medical devices 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. GET STARTED [email protected] Unlock this article — plus daily intelligence on Capitol Hill and the life sciences industry — by subscribing to STAT+. First 30 days free. GET STARTED Diana Alame What’s included? Duodenoscopes, flexible tubes inserted in the mouth in order to reach the small intestine, were the subject of long-running safety concerns. FDA via APcenter_img Tags medical devicespolicy By Diana Alame June 7, 2017 Reprints 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. Log In | Learn More The now-infamous superbug outbreak related to a medical device that seriously sickened 350 people and killed at least 20 illustrates a huge problem in our medical system: poor monitoring of the safety of medical devices.The episode in question lasted several years and involved a widely used duodenoscope, a flexible tube inserted in the mouth in order to reach the small intestine, made by Olympus. It began in January 2012 when Erasmus Medical Center in the Netherlands experienced an outbreak of a multidrug-resistant infection among 30 of its patients. An investigation linked the outbreak to the use of a specific Olympus duodenoscope, whose design flaws made it impossible to completely disinfect the device. About the Author Reprintslast_img read more

In defense of Medicare’s annual wellness exam

first_imgFirst OpinionIn defense of Medicare’s annual wellness exam The more relaxed nature of these visits helps some patients tell me things they might not have mentioned in a visit for an illness like an upper respiratory infection. During wellness visits, patients have told me about bothersome urinary incontinence and troublesome hearing loss. I have been surprised to learn that some patients do not have carbon monoxide detectors at home or have started smoking again. I have learned of patients who are experiencing problems with balance or mobility, leading me to refer them to physical therapy for exercises to prevent falls or possibly for evaluation for a device to help them walk more safely. I have recommended to some patients that they get medical alert devices, and encouraged others to think about with whom and where they would want to live if their health declined.Many of these issues may not have come up without the time allotted by the annual wellness exam and the prescriptive nudges embedded in it that help me think about my patients’ physical function, social support, and quality of life.My experience with Medicare’s annual wellness exam has been extremely favorable. I think my patients feel the same way. They often tell me at the end of the exam that they feel well cared for and that they are “very pleased” with the visit. In a recent First Opinion article, Dr. Ishani Ganguli notes that Medicare annual wellness exams are driven more by doctors offering these visits than by patients asking for them. It’s true that none of my patients scheduled an appointment with me specifically for a “Medicare annual wellness exam,” though some of them came in saying that they were there for a physical. None complained about receiving an annual wellness exam, although a few felt burdened about completing the health risk assessment form that is required as part of these exams.Unlike Dr. Ganguli, I’m not conflicted about the value of Medicare’s annual wellness visits. Instead, I believe they are a move in the right direction. They let me think about the care of my older patients in a comprehensive manner, rather than struggling to manage each of their health issues compartmentally.To be sure, Medicare’s free annual wellness visits should be evaluated in order to learn which parts of them work and which don’t. That way we can improve these visits and design systems to support them. Equally important, we should find ways to increase awareness about them among patients and physicians so more older adults have a chance to experience these visits and receive the best care possible.Mara A. Schonberg, M.D., is a primary care physician at Beth Israel Deaconess Medical Center and associate professor of medicine at Harvard Medical School. Once breast cancer is detected, nearly all older women undergo treatment for it. Yet there are risks associated with treatment. For these reasons, the American Cancer Society and other organizations recommend that older women who expect to live fewer than 10 more years not have screening mammograms. The rationale is that these women are unlikely to live longer as a result of being screened and that screening puts them at risk for experiencing harms related to the diagnosis and treatment of their cancer. Mara Schonberg Does Medicare’s free annual wellness visit do any good? By Mara Schonberg June 23, 2017 Reprints In my work as a primary care physician, time is a precious commodity. I rarely have enough of it in office visits with my patients. That’s one reason I’m all in favor of Medicare’s free annual wellness visits, though I know that other physicians feel differently about them.I began performing these exams with my older patients when Medicare began covering them in 2011. They afford me much-needed time to counsel my older patients about the potential benefits and risks of the ever-increasing number of preventive health measures available to them. I don’t simply check off whether a patient is up to date with his or her colonoscopy or other screening tests. (Screening means checking a seemingly healthy person for signs of hidden disease.) Instead, I use this time to talk with my patients about their overall health and goals so I can offer recommendations about their care that are in line with their values and preferences.There is a delay — sometimes a long one — between having a screening test and possibly benefiting from it. Patients must decide if they want to undergo a test today that may have some immediate risks to detect a disease that could cause them harm in the future but may never do that. For example, an older woman who has a mammogram today may be diagnosed with a small breast cancer. For many of them, this cancer is unlikely to have caused any harm for a number of years and may, in fact, never harm them.advertisement Tags agingcancerMedicarewellness @Mara_Schonberg Related: About the Author Reprints APStock Explaining the nuances of screening and the sometimes difficult-to-understand balance of benefits and risks isn’t easy to do in a minute or so. The Medicare annual wellness exam gives me time to discuss and individualize the benefits and risks of screening for breast, colon, prostate, and lung cancer based on the patient’s risk, life expectancy, and preferences. The visit also gives me time to provide individualized recommendations about the use of aspirin and statin medications for primary prevention of heart disease. Without the annual wellness visit, I would have limited opportunity to engage my older patients in these preference-based decisions.advertisementlast_img read more

New risk calculator could change the aspirin, statins, and blood pressure medications some people take

first_img What’s included? GET STARTED New risk calculator could change the aspirin, statins, and blood pressure medications some people take By Elizabeth Cooney June 4, 2018 Reprints General Assignment Reporter Liz focuses on cancer, biomedical engineering, and how patients feel the effects of Covid-19. Elizabeth Cooney What is it? Health @cooney_liz About the Author Reprintscenter_img APStock More than 11 million people may need to reconsider taking medications to avoid heart attack and stroke, according to new research that says current guidelines overestimate risk for some people, but underestimate risk for others, especially African-Americans.Right now, doctors can consult a calculator found online or in electronic health records to decide whether patients might benefit from aspirin, statins, or blood pressure medications. Those estimates of 10-year risk for cardiovascular disease were derived in 2013 and endorsed by the American College of Cardiology and the American Heart Association. They were based on statistical analyses that combined data from large studies such as the original Framingham Heart Study, whose participants were 30 to 62 years old in 1948. Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Log In | Learn More [email protected] 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. 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 cardiologypatientslast_img read more

Research into new macular degeneration treatments takes off as cases steadily rise

first_imgBiotech By Robert Weisman — Boston Globe Sept. 10, 2018 Reprints [email protected] @GlobeRobW 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. Althea Lank is treated for age-related macular degeneration at Massachusetts Eye and Ear Infirmary in Boston. Craig F. Walker/The Boston Globe Log In | Learn More Robert Weisman — Boston Globe GET STARTED Unlock this article — plus daily coverage and analysis of the biotech sector — by subscribing to STAT+. First 30 days free. GET STARTED What’s included? STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. About the Author Reprints Sometimes it starts with wavy vision. Objects appear distorted. Familiar faces go blurry.Sean Teare, a 48-year-old health care consultant from Duxbury, Mass., struggled to read menus in dimly lit restaurants. After a battery of tests, his optometrist told him he had age-related macular degeneration, or AMD, an eye disease that afflicts more than 9 million Americans and can cause serious vision loss. “It came as a complete shock,” said Teare. What is it? Research into new macular degeneration treatments takes off as cases steadily rise Tags biotechnologypharmaceuticalsSTAT+visionlast_img read more