June 2021

Why every clinical trial should have an app for participants

first_img Tags clinical trialsdrug makerspatients Glen de Vries We are well into the era of the engaged consumer. By now, many companies have recognized that traditional selling tactics like advertising and discounting only take them so far. Consumers want deeper connections, and companies ranging from Amazon and Apple to Spotify and Zappos have been happy to oblige. Using predictive algorithms that prioritize consumer preferences, these companies are finding inventive new ways to engage customers with games, stories, and sharing tools sent to their mobile devices.Pharmaceutical companies should be doing the same thing. But many of them aren’t, or aren’t doing it well. For 16 years, I’ve witnessed their halting efforts to engage consumers from my vantage point as the cofounder and president of a cloud technology company that helps life science organizations better design, manage, and execute clinical trials.A clinical trial is often the first chance that a pharmaceutical company has to engage with individuals who may one day be their customers. Many companies ignore this opportunity. By doing so, they fail to gather invaluable information about the effectiveness and safety of their products and the responsiveness and progress of the people taking them.advertisement By Glen de Vries April 5, 2016 Reprints In a clinical trial, what does an engaged consumer look like? He or she feels confident of having an open, consistent dialogue with doctors and clinicians; intimately understands the purpose of the trial and his or her role in it; and is committed to following study protocols, making follow-up visits, and ultimately completing the trial.Few pharmaceutical companies do enough to help study participants meet this level of engagement. Consider these facts about clinical trials: The average dropout rate is around 30 percent, and about 80 percent of clinical trials don’t finish on time. A key contributor to both of these problems is poor patient engagement. Some participants drop out of trials for reasons a sponsor can’t control, like negative reactions to a treatment. Far more often, the sponsors aren’t doing enough to educate participants, make it easy for them to follow the study protocols, or motivate them to stay engaged.advertisement About the Author Reprintscenter_img Some drug companies have taken baby steps toward engagement by launching patient-focused apps after getting approval for their drugs. By then, it’s too late.Fortunately, technologies available today have enormous potential to improve the quality of clinical research and the level of patient engagement. Devices like Fitbit or Jawbone can do a lot more than tell you how many steps you’ve taken or how well you are sleeping. They can also provide a more precise understanding of how an individual responds to treatment during a clinical trial. Meanwhile, emerging software platforms like Apple’s CareKit will help developers and health care professionals create new interactive health care-related apps.These tools can make it easier for clinical trial sponsors to improve engagement, whether it’s making participation easier by reducing the need for trips to a clinic or providing reminders for taking medicines in the right dose at the right time.Clinical trials are the perfect environment in which to identify and focus on successful patient engagement strategies. For any pharmaceutical company or clinical trial sponsor looking to improve patient engagement, three priorities are key:Act now. The FDA requires that all new therapeutics be tested in a rigorous, three-phase process. Engagement should be baked into this process from the start. The best time to study patients’ habits, preferences, and behaviors is during a trial as participants use the new drug, not after it has been approved.Be objective. Clinical trial research often ignores objective measures about participants’ quality of life and instead relies on subjective data collected in surveys. Today’s mobile technologies let researchers continuously collect consistent, reliable, objective information about things that are meaningful to participants, such as the quality of their sleep or their ability to walk through the grocery store without fatigue.Go with what works and what patients know. Pharmaceutical companies needn’t completely reinvent the customer engagement experience. People are increasingly and habitually using tools such as smartphone apps and activity trackers. The challenge for pharmaceutical companies is to keep up with the pace of digital innovation and understand the way new technologies can be used to reduce the burden that a clinical trial can place on participants.To combine emerging digital technologies with traditional clinical measurements and techniques, existing hardware and software must be adapted for clinical use. There is clearly a lot of work to be done, but we already have the tools to increase patient engagement for new drugs. The key is to start early in the process.Glen de Vries is president and cofounder of Medidata, which provides a cloud platform and data analytics for life science organizations conducting clinical research. First OpinionWhy every clinical trial should have an app for participants @CaptainClinical APStocklast_img read more

With brain training and an exoskeleton, paraplegics seem to regain some feeling in their legs

first_img Andrew Joseph About the Author Reprints [email protected] Related: Paraplegics who learned to control an Iron Man-like exoskeleton with their thoughts appeared to regain some feeling and function in their legs as a result of the training regimen, according to a new study.The study, published Thursday in the journal Scientific Reports, describes how a year of training enabled participants with spinal cord injuries to recover some sensation, voluntary muscle contraction, and control over bowel function — evidence of neurological recovery that the authors were not expecting.Four of the eight participants had their paralysis reclassified to a less severe level, although they still do not have control over most of their leg muscles.advertisement Tags brainneurologyparalysis Related: The training relied on what is known as a “brain-machine interface,” which decodes the brain’s signals into outputs aimed at enabling movement.advertisement A dogged quest to fix broken spinal cords pays off with new hope for the paralyzed @DrewQJoseph General Assignment Reporter Andrew covers a range of topics, from addiction to public health to genetics. Paralyzed, yet walking againVolume 90%Press shift question mark to access a list of keyboard shortcutsKeyboard ShortcutsEnabledDisabledPlay/PauseSPACEIncrease Volume↑Decrease Volume↓Seek Forward→Seek Backward←Captions On/OffcFullscreen/Exit FullscreenfMute/UnmutemSeek %0-9 facebook twitter Email Linkhttps://www.statnews.com/2016/08/11/paraplegics-exoskeleton-brain-training/?jwsource=clCopied EmbedCopiedLive00:0000:4300:43 center_img The participants in the study were injured three to 13 years ago. The goal of the project is to develop and refine the thought-controlled exoskeletons.The training started with participants practicing moving an on-screen avatar with their thoughts. Electrodes captured their brains’ signals and translated them through a computer so that when participants imagined walking, the avatars walked. The participants also trained with a harness-like system that helped them stand and walk on a treadmill, and eventually, worked their way up to controlling the exoskeletons.But as the participants trained, they regained some sensation in their lower limbs (although they could not sense changes in temperature) and some ability to voluntarily control muscles below the site of their injuries. Some of the participants saw improved bowel function and advances in their independence at home, such as being able to move themselves from their wheelchairs to the toilet. (The improvements in bowel and bladder control could also have come as a result of the participants being upright and out of their wheelchairs more often during the training program, not solely as a result of the interface training itself.)The advances made by the participants are likely possible because some of the nerves at the site of their injury survive, as other research has shown. And with the intensive training, the brain’s cortex restarted firing the signals it once did to command the muscles in the legs to contract, reigniting the nerves at the site of the injury. Those nerves then relayed the messages onward to nerves in the legs.“Something may have survived the original trauma, even if it were years ago,” Nicolelis said. By Andrew Joseph Aug. 11, 2016 Reprints The training described in the paper took place mostly in 2014, but Nicolelis said the participants who have kept up with some level of training have continued to show progress. The recovery seen in one participant who left the study waned after several months.Nicolelis’s approach is one of several that scientists are pursuing to restore mobility in patients with spinal cord injuries. Scientists are trying to reroute the brain’s signals around the site of injury, while others are trying to electronically stimulate a spinal cord. Still others think injecting new cells into the injury site could restore the cord’s function.For now, Nicolelis said the new research amounts to a demonstration of a technology that deserves further study. But he said he and his colleagues are wondering how they could make the technology accessible if the results hold up.“We’re already thinking about ways of disseminating this protocol,” he said. A shattering crash, an online chronicle, and an unexpected twist The study, which took place in Brazil, is not going to immediately change the course of therapy for the thousands of people with paraplegia around the world. The eight participants together took part in more than 2,000 training sessions to achieve small and what might not be sustainable gains.But the results suggest that by using their thoughts to control an external device, participants were also jumpstarting some long-dormant nerve networks and connections in the brain and spinal cord.“All this machinery is reactivated and you start bombarding the spinal cord — what’s left of it — with information,” Nicolelis said.Brain-machine interfaces have been used to allow people who are paralyzed to move robots, trigger hand movements via electrodes on the arm, and, in the case of Nicolelis’s study, control an exoskeleton. At the opening of the 2014 World Cup in Brazil, a paraplegic participant kicked a ball while wearing the exoskeleton — a movement caused by the participant’s own thoughts routed through electrodes on his head to a computer to the exoskeleton.In those cases, the interface acted as an assistive technology, helping patients control external devices. But the new study indicates that the interfaces might also serve as a therapeutic technology, restoring some level of function that the body had lost, said Dr. Elliot Roth, the medical director of the patient recovery unit at the Rehabilitation Institute of Chicago. Roth, who also chairs the physical medicine and rehabilitation department at Northwestern University Feinberg School of Medicine, was not involved in the study.The results of the study need to be reproduced and researchers need to think how the technology could be applied to patients broadly, Roth said. But he called the study “an exciting first step.” Brain implant helps quadriplegic move his hand — and play Guitar Hero In the LabWith brain training and an exoskeleton, paraplegics seem to regain some feeling in their legs In 2014, researchers in Brazil unveiled a brain-controlled exoskeleton that allows paraplegics to walk again. Today, something unexpected is happening to longtime users of the technology. Alex Hogan/STAT Related: “It turned out that six months into the training of these patients … we started realizing that the patients were experiencing an improvement in their neurological function,” said Dr. Miguel Nicolelis, a Duke University neurobiologist and senior author of the paper.last_img read more

Concussion researchers spark hope with a new tool to diagnose brain damage

first_img @ericboodman But with each head trauma, scientists think, some neurons release that tau into the rest of the brain, and as it moves around, bits of this protein get tangled and stuck together.“Once it gets a foothold, then its progression accelerates and even after you stop taking hits, it keeps accumulating and keeps getting worse,” said Eric Nauman, a biomedical engineer at Purdue University, who studies brain trauma.Those accumulations of tau are what pathologists are looking for during autopsies. And earlier this year, a group of the top brain scientists agreed that what distinguishes CTE from other tau-related disorders like Alzheimer’s is a peculiar pattern of protein buildup deep in the folds of the brain.Gandy looked for a way to pick up the same pattern while the patient was alive. To do that, he used a molecule — what scientists call a ligand — that is safe to inject but would also stick onto the tangles of tau.“The shape of the tau in the normal neurons is basically like a piece of spaghetti,” he said. “With the tangles, it’s twisted and kinked, and it’s those kinks where the ligand binds.” The diagnosis begins with the brain being pulled out of the skull.Then, to determine whether someone had a condition associated with repeated concussions, the pathologist preserves the tissue in formalin, slices it thin enough for light to shine through, washes it with chemicals, and peers at it through a microscope. If some areas remain blotched with reddish brown, then the pathologist can definitively diagnose the person with chronic traumatic encephalopathy, or CTE.The procedure has helped scientists advance their understanding of the condition but it has done little to help thousands of football players, former service members, and others who have CTE.advertisement Eric Boodman Tags concussionsCTEfootball After a public fall, the face of NFL concussion denial resurfaces Blood test shows evidence of concussion up to a week after injury The stakes for this science are high. CTE is an incurable neurodegenerative disease that has been associated with everything from depression, anxiety, and aggression to progressive, Alzheimer’s-like dementia. So a diagnosis is not something to take lightly — and could be disastrous if gotten wrong.advertisement “There are cases out there, unfortunately, of people who were convinced they had CTE and committed suicide, and then were found in autopsy not to have CTE,” said Dr. Christopher Giza, director of the UCLA Steve Tisch BrainSPORT program, who was not involved in the study.It’s hard to say exactly how good the new diagnostic test might be because this study was conducted on just one retired NFL player, and he is still alive.“These findings in this patient strongly suggest a diagnosis — they probably have CTE — but we can’t definitely say that without an autopsy,” said Dr. Cyrus Raji, a CTE researcher at the University of California, San Francisco, who was also not involved in the study. Inside the battered brainVolume 90%Press shift question mark to access a list of keyboard shortcutsKeyboard ShortcutsEnabledDisabledPlay/PauseSPACEIncrease Volume↑Decrease Volume↓Seek Forward→Seek Backward←Captions On/OffcFullscreen/Exit FullscreenfMute/UnmutemSeek %0-9 facebook twitter Email Linkhttps://www.statnews.com/2016/09/27/cte-diagnosis-concussion/?jwsource=clCopied EmbedCopiedLive00:0001:5201:52  Concussions, or even more mild, repetitive head trauma, may lead to a degenerative brain disorder called chronic traumatic encephalopathy. Alex Hogan, Hyacinth Empinado/STAT CTE was first described in 1928, when a pathologist coined the term “punch-drunk” to talk about how repeated head-bashings affected boxers. The more official diagnosis of dementia pugilistica — literally, “fighters’ dementia” — was subsequently found in cases of physical abuse, epilepsy, rugby, and even “dwarf-throwing.” But it was only described in football players in 2005.For years, the National Football League resisted science showing that repeatedly hitting your head may cause lasting brain damage.Neurologists think that the brain damage associated with CTE is linked to a protein called tau, which is an essential part of normal, healthy neurons. “The structure is maintained by an internal skeleton of the nerve cell, and that skeleton is composed of tau,” explained Dr. Samuel Gandy, the Mount Sinai neurologist who led the new study. Related: Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day. By Eric Boodman Sept. 27, 2016 Reprintscenter_img Related: Privacy Policy Leave this field empty if you’re human: By linking up this molecule to a radioactive atom and then injecting it into the patient, Gandy could use a PET scanner to track its progress through the brain. Wherever these radioactive chains got stuck was a tangle of tau. And in this patient, the tangles of tau were strikingly similar to the pattern seen during autopsies that allows for an official diagnosis.The patient is a 39-year-old retired NFL player who has complained mostly of poor moods and episodes of rage. “He certainly is not demented. He runs his own business. He’s independent and functional and has a family,” said Gandy.While the new study may represent a step forward, it will not be accepted as diagnostic tool until a large study is done of both affected and non-affected brains, while the patients are alive and then after death. “On the basis of that test, you’re going to make a pretty important determination: ‘You’re depressed because you need to see a therapist or need medication,’ or ‘You’re depressed because you have an incurable degenerative disease.’ I would want to be very, very convinced before I declare judgment on patients one way or another,” said Giza, of UCLA.In spite of the uncertainty, Gandy said, 100 service members have already come forward, wanting to be scanned. The first ones will visit his clinic in October.Correction: A previous version of this article mischaracterized the relationship between CTE and symptoms such as depression, anxiety, aggression, and dementia.  [email protected] On Tuesday, researchers at the Icahn School of Medicine at Mount Sinai in New York reported they had developed a potential method to diagnose CTE while patients are still alive. Instead of taking out the brain to douse it and slice it, doctors inject chemicals that will flow up into the brain, and then send the patient into a brain scanner. In the LabConcussion researchers spark hope with a new tool to diagnose brain damage A retired NFL player’s PET scan. The yellow and red blotches indicate tau deposition. Translational Psychiatry General Assignment Reporter Eric focuses on narrative features, exploring the startling ways that science and medicine affect people’s lives. Please enter a valid email address. About the Author Reprintslast_img read more

Pfizer sues Texas agency over releasing Medicaid data to lawmakers

first_img Tags MedicaidPfizertexas Richard Drew/AP About the Author Reprints By Ed Silverman Nov. 18, 2016 Reprints Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. The lawsuit arises as a national debate ensues over prices for prescription drugs. Rising costs — for new and old drugs alike — have inflamed the public and put the pharmaceutical industry on the defensive. Meanwhile, state lawmakers and agencies are looking for ways to lower costs in hopes that needed medicines do not become budget busters.advertisement Ed Silverman Newsletters Sign up for Pharmalot Your daily update on the drug industry. In Texas, lawmakers have sought to determine these costs. And Charles Schwertner, who chairs the state Senate Committee on Health and Human Services, earlier this year asked the state agency for information on rebates that drug makers provide the state Medicaid program. Initially, the state agency declined to release the data.But last July, Texas Attorney General Ken Paxton determined the data could be released. This prompted Pfizer to file a lawsuit against the attorney general, claiming the disclosure violated state law and was never notified its data may be released. Meanwhile, the state agency also released the data to the chair of the state Senate Finance Committee who, in August, also requested the information.“Right now, it’s somewhat nebulous and opaque with not having sure certainty regarding what actually is costing the taxpayers of Texas,” Schwertner told the Texas Standard last month after Pfizer filed its first lawsuit. “So I’m trying to find out the balance between what type of prescription drug benefit plan and the cost of it, and how to manage it more effectively and efficiently.” In the latest struggle over pharmaceutical costs, Pfizer has filed a lawsuit against a Texas state agency for releasing Medicaid rebate data to a pair of state lawmakers, claiming the move violated federal and state laws that protect its confidential information.By releasing the data, Pfizer argued the Texas Health and Human Services Commission compromised “valuable and commercially sensitive trade secrets” that could hurt its ability to compete with rivals, according to the lawsuit, which was filed in federal court in Austin, Texas, on Thursday. “Small differences in pricing and rebates can make the difference between success and failure,” the lawsuit stated.The drug maker also contended that disclosure can lead to “uniform pricing” that could harm Medicaid. How so? Pfizer maintained that, if other large purchasers were to know about — and then demand — the same prices offered to the Texas Medicaid program, the company “would not be able to provide such pricing and rebates to every entity due to their unique differences in size, market and particular needs.”advertisement PharmalotPfizer sues Texas agency over releasing Medicaid data to lawmakers Related: Leave this field empty if you’re human: Although the cat is out of the bag, Pfizer asked the court for a temporary restraining order and a preliminary injunction to prevent the Texas Health and Human Services Commission from releasing data in response to any additional requests. The drug maker also wants to be notified in the event that other requests are made.“The more legislators and staffers gain access to such information, the more difficult it is to secure the information, identify the source of leaks, and sue the correct source,” the suit stated.A spokeswoman for the Texas Health and Human Services Commission wrote us that the agency is “aware of the suit and will respond at the appropriate time.”This is likely to be a closely watched case, given the tremendous interest in pharmaceutical costs and the mystery surrounding rebates. If Pfizer prevails, the intrigue is likely to continue. @Pharmalot [email protected] Privacy Policy Drug makers are required to pay rebates to Medicaid. But without confidentiality for specific pricing data, “Medicaid would be unable to obtain such preferential discounts and rebates, which would dramatically increase the costs of the Medicaid program to both the states and the federal government,” Pfizer argued. And the drug maker added that “the low rates that Texas Medicaid enjoys would disappear.” Please enter a valid email address. Pfizer to pay $784M to settle claims it overcharged Medicaid last_img read more

Facing significant yellow fever outbreak, Brazil appeals for more vaccine

first_img Researchers say yellow fever in Brazil means a chance of the disease coming to the US @HelenBranswell Newsletters Sign up for Morning Rounds Your daily dose of news in health and medicine. Senior Writer, Infectious Disease Helen covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development. About the Author Reprints There have been 255 deaths. The confirmed cases have been recorded in three states: Minas Gerais, Espírito Santo, and São Paulo.The health ministry recently announced it would vaccinate everyone in Rio de Janeiro state, and would also vaccinate people in parts of São Paulo state that have been deemed at risk.The yellow fever virus, like the related dengue and Zika viruses, is spread by mosquitoes. It is deadlier, though, than its cousins, with a significant fatality rate.The virus normally spreads in what is known as a jungle or sylvatic cycle, with transmission between Haemagogus mosquitoes and monkeys. Occasionally a person becomes infected, but human cases are generally rare in the jungle cycleBut if the virus finds its way into cities, it can infect Aedes mosquitoes, which live in close proximity to people, and that can trigger a cycle of hard-to-contain urban yellow fever. Given the severity of the disease, the specter of urban yellow fever alarms public health officials. Still, the World Health Organization said last week that to date there is no evidence that Aedes mosquitoes are spreading the virus. By Helen Branswell March 21, 2017 Reprints Privacy Policy Leave this field empty if you’re human: People who contract yellow fever can experience fever, headache, backache, muscle pains, loss of appetite, and nausea or vomiting. Those symptoms typically last three or four days. But about 15 percent of people then suffer a relapse, entering what is called a toxic phase in which they develop jaundice and more severe illness. Roughly half of the people who reach the toxic phase die.In the Rio de Janeiro state, there have been two confirmed cases in a city located about 62 miles from the city of Rio de Janeiro, and four cases have been confirmed in cities located in São Paulo state between 160 miles and 220 miles from the city of São Paulo. The urban centers of Rio and São Paulo have populations of more than 6 million and 12 million people, respectively.Given the situation, the WHO announced last week that international travelers who are traveling to Rio de Janeiro and São Paulo states should be vaccinated against yellow fever, though it exempted those whose travels are restricted to the cities of Rio de Janeiro and São Paulo as well as the cities of Niterói and Campinas.The international emergency yellow fever stockpile, which normally contains 6 million doses, is managed by the International Coordinating Group on Vaccine Provision, which is a coalition of four agencies: the International Federation of Red Cross and Red Crescent Societies, Doctors Without Borders, the United Nations Children’s Fund (UNICEF), and the WHO.Last year that stockpile distributed nearly 30 million doses of yellow fever vaccine to help extinguish a dangerous outbreak in Angola that spilled into the Democratic Republic of Congo, as well as an unrelated outbreak in Uganda. Helen Branswellcenter_img But since last December, Brazil has recorded a larger-than-normal number of cases of yellow fever. And as cases have crept ever closer to two of the country’s largest cities — Rio de Janeiro and São Paulo — there have been fears that the disease could start to spread in these cities and, from them, to other parts of the Americas. As of March 13, there had been 1,538 cases of yellow fever reported, according to Brazil’s health ministry. Of those, 396 have been confirmed and 184 discarded. More than 950 suspected cases remain under investigation.advertisement ExclusiveFacing significant yellow fever outbreak, Brazil appeals for more vaccine Please enter a valid email address. Related: Brazil, in the grips of an unusually large yellow fever outbreak, has asked for millions of doses of vaccine from an international emergency stockpile.The body that maintains and manages the stockpile, the International Coordinating Group on Vaccine Provision, has approved the release of more than 3.5 million doses of the vaccine, according to the Brazilian office of the Pan American Health Organization. The office said the vaccine should arrive in Brazil over the next few days.The request signals public health officials’ increasing concern over the scale of Brazil’s outbreak. The country is already home to one of four yellow fever vaccine manufacturers in the world, and it normally produces enough to meet its own needs.advertisement A mother comforts her 5-year-old daughter as a health worker prepares to inject her with a yellow fever vaccine in Casimiro de Abreu, Brazil. Leo Correa/AP Tags public healthVaccineslast_img read more

Arizona is first state to pass a law allowing drug makers to promote off-label uses

first_imgPharmalot Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED In what some observers are calling a misguided effort, Arizona has become the first state in the nation to pass a law allowing drug makers to promote their medicines for so-called off-label uses — so long as the information given doctors is truthful.Interestingly, the law was hatched by the Goldwater Institute, the same think tank that spearheaded the controversial Right to Try laws designed to give patients early access to experimental medicines. And the think tank is vowing to duplicate that campaign by introducing off-label bills around the country. [email protected] By Ed Silverman March 29, 2017 Reprints APStock Ed Silverman Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. 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.center_img Log In | Learn More GET STARTED About the Author Reprints What is it? Arizona is first state to pass a law allowing drug makers to promote off-label uses @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. Tags pharmaceuticalspolicySTAT+last_img read more

Lawmakers push bill to reverse a Trump rule over Medicare drug discounts

first_imgPharmalot Tags hospitalsMedicarepharmaceuticalsSTAT+ [email protected] @Pharmalot Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. By Ed Silverman Nov. 16, 2017 Reprints STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Paul Beaty/AP What’s included?center_img Ed Silverman What is it? About the Author Reprints GET STARTED A group of lawmakers introduced a bipartisan bill to reverse a Trump administration rule that would cut Medicare reimbursement for medicines purchased under the federal 340B Drug Discount Program, which was designed to boost revenues for hospitals that primarily serve low-income patients. The cut is estimated to save Medicare and its beneficiaries about $1.6 billion next year.The sponsors were among dozens of lawmakers who two months ago wrote the Centers for Medicare and Medicaid Services to argue that cutting reimbursement is a “misguided policy” that would limit the ability of hospitals to serve vulnerable patients. They further maintained the move would not reduce drug costs, as the pharmaceutical industry has suggested. Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED Lawmakers push bill to reverse a Trump rule over Medicare drug discounts Log In | Learn More last_img read more

Testing the tests: If two liquid biopsies deliver different results, can they both be right?

first_imgHealth What is it? Testing the tests: If two liquid biopsies deliver different results, can they both be right? Adobe [email protected] Unlock this article — and get additional analysis of the technologies disrupting health care — by subscribing to STAT+. First 30 days free. GET STARTED 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. 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 Log In | Learn More center_img The question had come from his boss. It was around the beginning of 2017, and the director of research for the Brady Urological Institute at Johns Hopkins asked Dr. Gonzalo Torga, a postdoctoral fellow, which of two genomic tests they should offer to their prostate cancer patients as a way of determining eligibility for certain drugs. Torga wasn’t sure, so his boss suggested they test the tests: Order a liquid biopsy from both companies for a number of patients, and then compare the results.Their findings, the Hopkins scientists say, were disconcerting: In many cases, the two tests gave conflicting results for the same patient. They published their comparison in JAMA Oncology in December, arguing that they needed to warn other clinicians that these tests don’t give standard results. But the companies in question retort that this warning is based on sloppy study design and could mean that patients don’t get offered potentially helpful tests. By Eric Boodman Jan. 19, 2018 Reprints What’s included? Eric Boodman General Assignment Reporter Eric focuses on narrative features, exploring the startling ways that science and medicine affect people’s lives. Tags cancerdiagnosticsSTAT+ About the Author Reprints @ericboodman last_img read more

Administrative delays threaten the promise of the 21st Century Cures Act

first_img Joel C. White Related: Please enter a valid email address. When President Barack Obama signed the landmark 21st Century Cures Act into law in December 2016, he was surrounded by elated Republican and Democratic lawmakers. At the time, Obama said the measure would bring “to reality the possibility of new breakthroughs to some of the greatest health challenges of our time.”Republican Sen. Lamar Alexander, who chairs the Senate’s Committee on Health, Education Labor, and Pensions, hailed the act as “a Christmas miracle … that will help virtually every American family.”Their statements weren’t hyperbole. The bipartisan $6.3 billion medical innovation package was chock-full of policies to modernize the National Institutes of Health and the Food and Drug Administration, combat the nationwide opioid epidemic, advance Obama’s Precision Medicine Initiative, and speed approval of new, lifesaving therapies for the most devastating of diseases.advertisement By Joel C. White Sept. 8, 2018 Reprints To that end, Section 4004 of the Cures Act gave the secretary of health and human services the tasks of issuing regulations to prevent information blocking and identifying “reasonable and necessary activities that do not constitute information blocking.”How’s that going?More than 600 days after the enactment of the Cures Act, not a single regulation has been issued on information blocking. In a Health Affairs column in June of this year, Dr. Don Rucker, who leads the Office of the National Coordinator for Health Information Technology (ONC), suggested that implementation of the law’s information blocking provisions would occur “over the next few years” — a vague timeline that shows little urgency for combating this pressing threat to consumer safety and stumbling block to interoperability.To be clear, Health IT Now has met with countless officials in the Trump administration who share our commitment to combat information blocking. But those sentiments must be met with meaningful action.My organization recently led more than a dozen leading health care organizations and companies — the American Academy of Family Physicians, McKesson, the National MS Society, Oracle, and others — in sending a letter to administration officials urging them to start implementing provisions against information blocking in the Cures Act.“Every day that the administration delays implementation of these critical provisions places patients at risk of harm,” we wrote. “We understand the nuance required but feel that it is past time for a proposal to be made.” One of the longtime goals of Health IT Now is the realization of true, nationwide interoperability. That means ensuring that an individual’s health information can flow seamlessly from one health care provider to another as well as to patients, offering an accurate picture of an individual’s health history at all times and keeping patients in control of their own health data.To that end, we secured the inclusion of tough language in the Cures Act to crack down on the harmful practice of information blocking. This occurs when vendors or providers willfully take actions that impede the flow of health information. It happens in many ways, most commonly when electronic health record software companies purposefully deploy nonstandard technology that cuts off communication with other health systems or charge exorbitant fees for exchanging information.Information blocking impedes health care providers from accessing the most current, accurate, or complete information on their patients. Just imagine your doctor not knowing of a serious allergy or prescribing a new medication without knowledge of all the others you are taking and possible drug interactions. When providers can’t make informed clinical decisions based on clear pictures of their patients’ health histories, patients’ lives are put in jeopardy. @HealthITNow Leave this field empty if you’re human: I should know. As executive director of Health IT Now — a broad-based coalition of patient groups, provider organizations, employers, and payers supporting the use of data and health information technology to lower costs and improve patient outcomes — my colleagues and I worked doggedly behind the scenes with lawmakers to add needed provisions to the law that would optimize the use of technology in our health care system.advertisement Patients would like their data, please. Will the medical device industry listen? In August, a bipartisan group of lawmakers led by Sens. Bill Cassidy (R-La.) and Sheldon Whitehouse (D-R.I.) crafted an important amendment to the “minibus” government funding bill that would require the administration to give Congress a progress report on their work establishing regulations against information blocking by Sept. 30.The Trump administration seems to understand the seriousness of the matter. It has reiterated that the proposed rule will be released in September while Rucker has said the regulation is “deep in the federal clearance process.”For the sake of patients everywhere, it’s time to bring it to the surface.Congress has done its part by getting the Cures Act signed into law — no small feat in the polarizing political climate during which it was forged. The administration must now uphold its end of the bargain.Joel C. White is the executive director of Health IT Now. But laws passed by Congress must be implemented through regulations. The Cures Act gave broad authority to the executive branch to execute and enforce both the spirit and the letter of the law. Nineteen months after the act became law, that task mainly remains undone. Newsletters Sign up for First Opinion A weekly digest of our opinion column, with insight from industry experts. First OpinionAdministrative delays threaten the promise of the 21st Century Cures Act Senate passes landmark 21st Century Cures Act — but it will take years to implement President Barack Obama applauds after signing the 21st Century Cures Act into law in December 2016. Chip Somodevilla/Getty Images Related: About the Author Reprints [email protected] Privacy Policy Tags Congressprecision medicineWhite Houselast_img read more

Health apps collecting sensitive data need more transparent terms of service, law experts argue

first_imgHealth Tech Health apps collecting sensitive data need more transparent terms of service, law experts argue [email protected] Tags Health ITmedical technologySTAT+ Reporter, Morning Rounds Writer, Intern Coordinator Shraddha writes the Morning Rounds newsletter and covers health and medicine. What’s included? By Shraddha Chakradhar Feb. 13, 2020 Reprints We’ve all been there. We’ve downloaded a new app or visited a website that requires us to enter personal data and immediately been presented with a long agreement that we have to agree to before using the service.And every so often, we may have been asked to reaffirm our consent to these terms of service, which outline what the company does with our data, including sharing it with third-party users for research or with their own internal teams to improve the quality of their product. @scchak 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.center_img Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. GET STARTED What is it? Shraddha Chakradhar About the Author Reprints Adobe Unlock this article — and get additional analysis of the technologies disrupting health care — by subscribing to STAT+. First 30 days free. GET STARTED Log In | Learn More last_img read more