Month: June 2021

3 people to watch in neuroscience in 2016

first_img @sxbegle Charlotte Chua for STAT [email protected] As the year winds down, STAT reporters are taking a look at the stories they’re most eager to track in 2016. We’ll be running these daily through Dec. 31. Look for more New Year’s predictions here. President Obama’s BRAIN Initiative is the biggest thing in brain science, and as such it’s what we at STAT have got our eyes on for neuroscience advances in the year ahead.The initiative awarded its first $46 million in grants in September 2014 and the next $38 million a year later. Although the projects are funded for three years, scientists have already reported interim findings, such as how they used designer molecules to turn mouse neurons on and off. Here are three groups to watch in 2016:D. Kacy Cullen, University of Pennsylvania Cullen and his colleagues are in hot pursuit of “neurosurgical reconstruction.” The idea is to rebuild brain circuitry with what they call “living electrodes”: tiny, biodegradable tubes packed with axons, the long filaments that carry signals out of one neuron and into another. The tubes are inserted into a brain, they melt away, and the axons form functional circuits with the rest of the cortex.advertisement It’s already worked in rat brains, the scientists reported in November, so 2016 could bring more progress toward rebuilding brains damaged by trauma and degenerative diseases such as Parkinson’s.Julie Ann Brefczynski-Lewis, West Virginia UniversityCurrent neuroimaging technology works only when someone is basically immobilized. As a result, it’s been challenging to study brain activity when people do what they do during their waking hours. Brefczynski-Lewis’s lab is working toward the first mobile brain imager so scientists can peer at brain activity while, for instance, someone is walking, playing a piano, meditating, or socializing.advertisement By Sharon Begley Dec. 23, 2015 Reprints About the Author Reprintscenter_img In the Lab3 people to watch in neuroscience in 2016 That device, called the AM-PET Helmet, could not only help crack the mysteries of the human brain, it could also potentially treat neurologic conditions, such as dementia, stroke, traumatic brain injury, and depression. The researchers have already made progress on the device, such as figuring out the best way to arrange detecters around the head.Nicholas Melosh, Stanford University A chemist and materials scientist, Melosh is emblematic of the BRAIN Initiative’s efforts to bring new perspectives and strengths to neuroscience. He and his team plan to make self-propelled electrodes to better study both basic brain processes as well as neurological diseases and brain injuries.Stiff push-in electrodes currently in use are hard to deploy to fine targets. Instead, Melosh envisions thousands of ultrathin flexible electrodes in a single implanted device that “will ‘pull’ themselves from the front” using a sort of front-wheel-drive technology, the scientists wrote in their proposal. They’re also looking for ways of steering the electrodes so “they can extend throughout the brain in three dimensions and plant themselves next to individual neurons.”That could help basic research, letting scientists measure activity in more precisely targeted brain regions of lab animals, and also possibly help patients, using electrodes to stimulate certain neurons as a way to treat memory problems and possibly even comas. Sharon Begley Senior Writer, Science and Discovery (1956-2021) Sharon covered science and discovery. Tags brainneuroscienceThree to watchlast_img read more

Supreme Court asks Obama administration for views on biosimilar rules

first_img Related: Tags biologicsdrug pricespolicySupreme Court Ed Silverman In a move with implications for health care expenses, the US Supreme Court has asked the Obama administration for its views on a heated dispute over a rule that will determine when lower-cost biosimilar medicines can be launched.At issue is the ability of brand-name drug makers to delay the introduction of biosimilars, which are highly identical versions of expensive biologics. And the court wants the US solicitor general to help determine whether it should hear about a contentious battle between two big drug makers — Amgen and Sandoz — that might settle the matter.The rule in question concerns the notice that a brand-name company is entitled to receive from a drug maker that wants to sell a biosimilar. But the rule has not been previously tested because the US Food and Drug Administration so far has approved only two biosimilars.advertisement J. Scott Applewhite/AP Privacy Policy Leave this field empty if you’re human: Sandoz argued that federal law allowed it to give Amgen notice of its marketing plans 180 days before winning marketing approval from the US Food and Drug Administration. But last summer, a federal appeals court decided that biosimilar companies must wait until they actually receive FDA approval before they must provide brand-name rivals notice of a product launch. So Sandoz asked the Supreme Court to overturn the decision.Essentially, the Supreme Court is being asked to decide an important policy question because if the appeals court ruling is allowed to stand, it would serve as a broader benchmark for the entire pharmaceutical industry going forward. The rule is found in a federal law known as the Biologics Price Competition and Innovation Act, which says a company seeking to sell a biosimilar must give the manufacturer of the brand-name biologic at least a 180-day notice before selling its drug. The purpose is to provide a brand-name company time to determine what, if any, patent challenges to pursue. And the dispute centers on when the notice begins. @Pharmalot Related: How so? Brand-name drug makers already have 12 years of exclusivity for their biologic medicines, and the additional 180-day notice would give these companies still more time in which to prepare patent challenges, which can delay biosimilar launches. In effect, the difference in timing is a valuable right for biosimilar companies, as well as a valuable impediment for brand-name drug makers.A great deal is also at stake for patients and payers because biosimilars are estimated to save as much as $44 billion in US health care costs over the next decade. Many insurers and analysts forecast that biosimilars will cost 10 percent to 30 percent less than brand-name biologics, although the number is a moving target, given that companies raise biologics prices to anticipate competition.“For everyone who pays for these drugs, the additional six months of exclusivity can add up to a lot of money,” said Elaine Herrmann Blais, a partner at the Goodwin Procter law firm, which represents drug makers that sell biologics and are developing biosimilars. She is also a coauthor of the firm’s Big Molecule Watch Blog.The current dispute began last year, when Sandoz, which is the generic unit of Novartis, won the right to sell a biosimilar version of Amgen’s Neupogen, a treatment used to boost white blood cell counts in chemotherapy patients and others with compromised immune systems. But Sandoz lost a court case over the timing required to provide notice to Amgen. At first blush, 180 days may not seem like a great deal of time. But six months can be significant.advertisementcenter_img Please enter a valid email address. PharmalotSupreme Court asks Obama administration for views on biosimilar rules This explains why the Supreme Court asked the solicitor general to share its thoughts and possibly help determine the extent to which the case is important enough to review now, rather than wait for more disputes to be decided by lower courts, according to William Jay, who is also a partner at Goodwin Procter and is a former assistant to the solicitor general.“The chances that Sandoz will persuade the court to take the case have just gone up,” he said.It’s worth noting that President Obama has repeatedly called for marketing exclusivity for biologics to be held to seven years, and not 12 years, in his annual budget proposals (see page 74). But the invitation to the solicitor general marks the first opportunity for the administration to offer its interpretation of the law governing the 180-day notice, and openly decide whether to side with brand-name drug makers or biosimilar companies, Jay added.“The executive branch has to make a choice,” he said. “Does it think the best outcome for public policy is to make people wait 180 days or not” for a lower-cost medicine? Unintended twist in Obamacare may cost some Medicare patients more for biosimilars Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Sandoz urges Supreme Court to review biosimilar launch rules About the Author Reprints By Ed Silverman June 21, 2016 Reprints [email protected] Newsletters Sign up for Pharmalot Your daily update on the drug industry.last_img read more

We break down Macklemore’s new song about opioids, line by line

first_img Rapper Macklemore has released a new song, “Drug Dealer,” about prescription painkillers and other addictive drugs. Glenn Hunt/Getty Images In the latest sign of how the opioid crisis is permeating popular culture, the rapper Macklemore this week put out a remarkable new song about prescription painkillers and other addictive drugs.Titled “Drug Dealer,” the song parcels out blame for an opioid crisis that kills 78 Americans a day, up fourfold since 1999. It forcefully calls out Congress (as doing the business of billionaire chiefs of pharmaceutical companies), drug companies (including OxyContin manufacturer Purdue Pharma), and doctors who prescribe potent painkillers and enable refill after refill. (In the song, featured artist Ariana DeBoo refers to a doctor as “my drug dealer” who “had the plug from Big Pharma”).Macklemore, it’s worth noting, has spoken publicly about his own experience abusing the opioid painkillers OxyContin and Percocet. He released the song in conjunction with this week’s television premiere of an MTV documentary in which he interviews President Obama about the opioid epidemic.advertisement “Subs” is a reference to Suboxone, an opioid medication that’s used to treat opioid addiction. It’s become a key tool in combatting the opioid crisis; the Obama administration over the summer raised a prescribing cap to widen access to Suboxone and other buprenorphine medications.But the drug has also been abused in and of itself, fueled by a vibrant black market and cash-only clinics that dole out the pills without proper counseling. The Centers for Disease Control and Prevention does not tally deaths caused by these treatments for addiction, but there have been plenty of reports of deadly overdoses from Suboxone.Still, many addiction experts say the bottom line is that Suboxone saves far more lives than it takes.The whole while, these billionaires, they caked up Paying out Congress so we take their drugs Murderers who will never face the judgeHey, look, a (blistering) reference to federal lobbying made it into a rap song.The makers of prescription painkillers wield significant clout on Capitol Hill and in statehouses all over the country. Over the past decade, they spent more than $880 million on federal and state lobbying, often seeking to block measures meant to curb the opioid crisis. That’s more than eight times what the gun lobby spent over the same period, according to a recent investigation from the Associated Press and the Center for Public Integrity.Executives at two of the companies that have been blamed for fueling the opioid crisis — John Kapoor of Insys Therapeutics and members of the Sackler family of Purdue Pharma — are indeed billionaires.And we dancin’ to a song about our face goin’ numb But I seen homies turn gray, noses draining blood I could’ve been gone, out 30s, faded in that tub“30s” is a reference to what has become among the most vexing street drugs in the last few years: pale blue oxycodone pills, in a 30-milligram dose.The opioid tablets typically go for $20 to $30 a pop on the black market, and people who get hooked later often turn to heroin. Law enforcement officials have recently reported a disturbing trend: Fake “30s” that look like oxycodone but actually contain far more deadly opioids, such as heroin or fentanyl.That’s Prince, Michael and Whitney, that’s Amy, Ledger and Pimp C That’s Yams, that’s DJ AM God damn they’re making a killingMacklemore’s recitation of the litany of celebrities whose deaths have been linked to prescription drug and alcohol use is a familiar one.The most recent such example, and perhaps the most potent symbol of the opioid epidemic, is the musician Prince, whose autopsy indicated that he accidentally overdosed last spring on the powerful painkiller fentanyl. Prescription opioids were also implicated in the overdose deaths, spread out over the past decade, of the hip-hop executive known as ASAP Yams, the DJ known as DJ AM, the actor Heath Ledger, and the rapper known as Pimp C.Alcohol or other non-opioid prescription drugs were blamed in the deaths of the singers Whitney Houston, Amy Winehouse, and Michael Jackson.Now it’s getting attention ’cause Sara, Katey and Billy But this shit’s been going on from Seattle out to South Philly It just moved about the city And spread out to the ‘burbs Now it’s everybody’s problem, got a nation on the vergeMacklemore’s message here — that the opioid epidemic does not discriminate in the type of communities it ravages — is strikingly similar in vision (if not in language) to the alarm being sounded by the public health community and the Obama administration.Just last week, in fact, the White House hosted Macklemore for a panel discussion on the crisis with federal drug czar Michael Botticelli.While drug abuse has historically been clustered in urban areas, it’s clear that this epidemic doesn’t fit that pattern, though there’s little good data about the breakdown. Suburban and rural communities in many swing states, including Ohio and New Hampshire, face few more pressing issues than how to fight the epidemic.The issue hasn’t come up so far in the presidential debates, though voters in some of the most devastated communities don’t think either Hillary Clinton or Donald Trump will save them.Take Actavis off the market, jack the price up on the syrup But Purdue Pharma’s ’bout to move that workHere’s a somewhat opaque reference to a prescription opioid cough syrup, prominently abused in the hip-hop community a few years ago as a way of getting high. In 2014, the drug’s maker, then known as Actavis, pulled it from the market in response to the abuse, a move that sent the street price of the suddenly scarce drug through the roof.And then, right before the chorus begins, there’s a reference to Purdue Pharma, which has been vilified for sowing the seeds of the opioid crisis by aggressively marketing OxyContin. My drug dealer was a doctorVolume 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/2016/10/13/macklemore-opioid-addiction/?jwsource=clCopied EmbedCopiedLive00:0000:0700:07  Dom Smith/STAT My drug dealer was a doctor, doctor Had the plug from Big Pharma, Pharma He said that he would heal me, heal me But he only gave me problems, problems My drug dealer was a doctor, doctor Had the plug from Big Pharma, Pharma I think he trying to kill me, kill me He tried to kill me for a dollar, dollarThe song’s haunting chorus, with vocals from DeBoo, holds doctors accountable for their role in fueling the opioid crisis. Research has demonstrated that widespread overprescribing of opioids for routine medical conditions got many people hooked and sent them down the path towards heroin.It’s clear that pharma companies targeted doctors with aggressive sales pitches to get them to prescribe potent painkillers. Some of the marketing material deliberately downplayed the addictive nature of the drugs. A trove of pharmaceutical company documents uncovered by STAT, for instance, shows how sales representatives used dinners, gifts, and even doughnuts to sway doctors to switch patients over to OxyContin.And these devils they keep on talkin’ to me They screamin’ “open the bottle,” I wanna be at peace My hand is gripping that throttle, I’m running out of speed Tryin’ close my eyes but I keep sweatin’ through these sheets, through these sheets Four horseman, they won’t let me forget I wanna forge a prescription, cause doctor I need some more of it When morphine and heroin is more of your budget I said I’d never use a needle, but sure, fuck it I’m caught up, I’m on one, I’m nauseous No options, exhausted This is not what I started Walkin’ carcass, I lost everything I wanted My blinds drawn, too gone to leave this apartmentMacklemore’s harrowing description of what it’s like physically to be dependent on opioids speaks to just how excruciating it is to get clean. Another survivor described the experience to STAT as “like you’re living in hell.”Forged opioid prescriptions have also exacerbated the epidemic. Though there doesn’t appear to be good data on their prevalence, it’s widespread enough to have sparked interest in electronic prescription and spurred drug stores to adopt stricter policies to avoid filling such prescriptions.Macklemore also gestures at some of the ways that prescription painkiller addiction can escalate. Take his reference to heroin: 80 percent of new users report that they got started on prescription painkillers. As for injection needles, sharing them can put users at risk of HIV. Ain’t no coming back from this percocetVolume 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/2016/10/13/macklemore-opioid-addiction/?jwsource=clCopied EmbedCopiedLive00:0000:1100:11  Dom Smith/STAT Death certificate signed the prenup Ain’t no coming back from this Percocet Actavis, Ambien, Adderall, Xanax binge Best friends with the thing that’s killing me Enemies with my best friend, there’s no healing me Refilling these, refilling these They say it’s death, death Institutions and DOCs So God grant me the serenity to accept the things I cannot change Courage to change the things I can And the wisdom to know the difference And the wisdom to know the differenceWhile much of the concern is focused on opioids, addicts often use them in combination with other types of drugs — worsening the consequences. Sedative drugs like Xanax, known to scientists as benzodiazepines, are involved in nearly a third of accidental overdose deaths from prescription opioids.The prescription refills that Macklemore references are another key driver of the problem. A study last year found that more than 90 percent of patients continued to get refills even after overdosing on opioid medications.Five northeastern states have passed legislation aimed at limiting the number of pills doctors can prescribe. (Preliminary findings also suggest that increased awareness among doctors is helping stem prescriptions).Macklemore concludes with a reference to the Serenity Prayer, which became a popular fixture at Alcoholics Anonymous meetings and has since migrated to recovery groups for opioid addiction. His new documentary, in fact, includes a scene at the Seattle recovery group that Macklemore attends, where the group recites the prayer. By Rebecca Robbins Oct. 13, 2016 Reprints Read on for STAT’s annotations of Macklemore’s lyrics — which are peppered with references to the faces and drivers of the epidemic — and the backstory on the problem that’s “got a nation on the verge.”They said it wasn’t a gateway drug My homie was takin’ subs and he ain’t wake upadvertisement Tags musicopioidsPurdue Pharma HealthWe break down Macklemore’s new song about opioids, line by line last_img read more

More opioids were prescribed here per person than anywhere else in the U.S.

first_img [email protected] By Andrew Joseph July 7, 2017 Reprints With that in mind, Martinsville still stands out. Even the jurisdictions ranked No. 2 (Norton, Va.) and 3 (Campbell County, Tenn.) on the CDC’s list trailed by comfortable margins — with about 3,375 and 3,300 milligram equivalents prescribed, respectively.(The report generally examined data at the county level, but Virginia has a number of cities like Martinsville that are not part of counties and are viewed as their own entities in federal studies.)advertisement Clay, Tenn.3002.02797.7 Andrew Joseph Walker, Ala.4079.32813.3 Campbell, Tenn.2305.03304.3 General Assignment Reporter Andrew covers a range of topics, from addiction to public health to genetics. Claiborne, Tenn.2581.72807.6 Jurisdictions2010 Per Capita MME*2015 Per Capita MME About the Author Reprints Norton City, Va.2647.53373.5 Martinsville, Va.5201.14086.9center_img @DrewQJoseph Martinsville, Va., is home to fewer than 13,500 people. Steve C./Creative Commons Pickett, Tenn.5542.62742.4 Wyoming, W.Va.2699.82660.1 From Washington, D.C., head southwest into Virginia for nearly five hours and put yourself due north from Greensboro, N.C. There you will find Martinsville, Va., where more opioids were prescribed per person in 2015 than any other jurisdiction in the United States.Clinicians in Martinsville, home to fewer than 13,500 people, prescribed almost 4,090 morphine milligram equivalents per person. The national average was 640 milligram equivalents per person.That contrast underlines the dramatic differences in opioid prescribing across the country as health officials try to tackle a national epidemic. A report from the Centers for Disease Control and Prevention this week found that while prescribing fell nationwide from 2010 to 2015, places that prescribed the most opioids were still doling out drugs at rates six times higher than the lowest tier of communities.advertisement Carbon, Utah2838.02817.0 HealthMore opioids were prescribed here per person than anywhere else in the U.S. *MME = morphine milligram equivalents.And from 2010 to 2015, Martinsville, like half the jurisdictions studied by the CDC, actually saw a decrease in opioids prescriptions, from 5,200 milligram equivalents per person to 4,090. And it’s likely that prescriptions have continued to fall since then.Since 2015 — the last year the CDC had data for — the agency and hospitals around the country have launched initiatives to rein in opioid prescribing. The CDC released guidelines for prescribing opioids for pain last year, and a Virginia hospital association came out with its own plan last April. Clinicians at Memorial Hospital in Martinsville also started working to reduce prescriptions in the middle of 2016, according to WSLS, a local news station.Representatives at the hospital as well as as the local health department were not immediately available for comment. Tags addictionopioidspublic health Dr. Anne Schuchat, who was serving as acting CDC director until Friday, told reporters that the overprescription of opioids has led to addictions and left people vulnerable to overdoses and deaths.That’s a pattern seen around the country, and recent state data from Virginia show how pervasive the problem has become in Martinsville.STATIn the city and adjacent Henry County, the rate of overdoses leading to emergency department visits was the highest in the state in January, at 32 per 100,000 people. Martinsville’s monthly overdose rate has fluctuated over the months, but it has generally been among the highest rates in the state.The demographics of Martinsville also reflect some — though not all — of the factors that the CDC researchers found were associated with high levels of opioid prescriptions. Data show more opioids being prescribed in areas with more white residents, higher unemployment rates, a greater concentration of doctors and dentists, and higher rates of disability and diabetes. The researchers estimated that the factors accounted for about a third of the prescribing differences seen among counties.Like many of the top prescribing places, Martinsville is a “micropolitan” area, essentially a big town or small city. It also has a higher unemployment rate than the average in Virginia, and a relatively high rate of people on disability. But its population is about 50 percent white and 46 percent black.There are a number of caveats to consider. The CDC data were based on the location of pharmacies where opioids were picked up, so people who lived elsewhere but filled their prescriptions in Martinsville could have contributed to its high rate. Many counties in the country also did not have data for the CDC to analyze.Top 10 places where opioids prescribing was highest in 2015 Galax, Va.2557.63119.4last_img read more

Pharmalittle: Trump vows, again, to lower drug prices; Celgene chair resigns and preps for Senate run

first_img Tags Donald Trumpdrug pricingpharmaceuticalspharmalittleSTAT+ Pharmalittle: Trump vows, again, to lower drug prices; Celgene chair resigns and preps for Senate run Ed Silverman [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. What’s included? Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. @Pharmalot Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Log In | Learn More center_img Pharmalot STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Good morning, everyone, and how are you today? We are just fine, thank you, now that we are organized for a trip to the STAT world headquarters, a periodic jaunt that provides us with time to dream up new ideas and focus our thoughts. Of course, we also stop for cups of stimulation. No doubt this may prove to be a busy day for you, as well, so feel free to soak up the tidbits assembled below as you prepare to conquer the world. Hope all goes well and, as always, do keep in touch …President Trump pledged to bring prescription drug prices “way down” and blasted drug makers for “very unfair” price discrimination overcharging Americans, STAT tells us. “It’s “very unfair to our country” that companies charge Americans more for the same prescription drugs that they sell at a lower cost in other countries, he said while swearing in former Eli Lilly (LLY) executive Alex Azar to head the Department of Health and Human Services. By Ed Silverman Jan. 30, 2018 Reprints Alex Hogan/STAT What is it? GET STARTED About the Author Reprintslast_img read more

I have brain cancer. Drug companies and med schools should be compensating me for my expertise

first_imgLeave this field empty if you’re human: The services that e-patients provide to fellow members of their communities and the hours of volunteer time they donate to nonprofit and advocacy organizations are free and heartfelt gifts of time and expertise. In my community, we describe those affected by brain tumors to be the closest family of support that we never wanted to join. The reward I receive for giving my time is that my experience stands to benefit others. When I place a call to an elected official to advocate for more research funding or respond to an email from a person with glioblastoma, it isn’t difficult to distinguish that investment of time from the time I spend preparing and delivering a lecture to an auditorium of clinicians.People living with disease, especially chronic or advanced illnesses, and those who have survived it are often more adept at navigating the complicated health care landscape than medical school faculty members. Patients can also offer sophisticated critiques of care delivery that improve clinical practice. That’s why I believe medical schools and teaching hospitals be more aggressive about incorporating the experiences of those receiving care. This perspective should be an integral part of medical education, and patient educators should be compensated for providing it.By providing insights that improve the design of clinical trials and enhance patient experiences, expert patients can help drug and device companies with their bottom lines. This work should not be seen as nice-to-have volunteer work. Instead, it should be compensated, just as these companies pay physicians and researchers for their time and expertise.This won’t happen unless patients fully realize the value of the services they provide, and band together to nudge teaching institutions and companies to acknowledge the same thing. Patients currently use moderated Twitter chats, Facebook groups, podcasts, and blogs as avenues of support for asking questions and seeking advice about treatments, side effects, and clinical trials. These connectivity platforms can also be leveraged to better organize the patient community, share best practices for acting as patient educators or consulting with industry, preparing resumes, craft talking points for how to respond when asked to teach or speak, and set speaker’s fees and consulting rates. Privacy Policy About the Author Reprints Expert patients are often invited to share their expertise with patient groups, medical schools, and pharmaceutical or device companies. Adobe Dear Sen. McCain: Here’s what I’ve learned from living with glioblastoma The author recovering from surgery in May 2016. Courtesy Adam Haydenwill be in contact with every day, as well as experience communicating with people who are sick or dying. Medical school often detaches physicians-in-training from their own physicality in order to differentiate physicianhood from patienthood.Learning from e-patients can close this gap. We know what communication strategies are effective for giving bad or terrible news. We know how to be in the presence of suffering. We have wrestled with prognoses alongside loved ones. We have submitted for prior authorization, paid out of pocket, and spent hours on hold with insurance providers. We’ve also developed vast technical knowledge about the treatment and management of our diseases.The value proposition is straightforward: Medical schools offer physicians-in-training a glimpse of what disease looks like. Patients provide a full view, along with insight into how disease feels. Medical schools need to close the knowledge and experience gaps, but currently do a poor job incorporating patients into medical education.Educating drug and device companies. Drug and device companies seek out e-patients to elicit informed perspectives from people who use their therapies. Patients are the end users, and they evaluate drugs and devices by their effects on quality of life, which is difficult to measure in laboratory settings or clinical trials.Companies sometimes reimburse e-patients for allowing their profiles to be published in marketing efforts as a way to demonstrate real-world use, for speaking at industry conferences, or for taking part in focus groups. But these honoraria often fall short of industry standards because few patients receive training on either the true value of their perspectives or on how to set speaking and consulting fees. What’s more, this compensation often carries noncompete clauses and disclosure statements that preclude further opportunities for patients to be reimbursed for their time and experience.That needs to change. Related: Tom Marsilje, a relentless advocate for cancer patients, dies at 45 Please enter a valid email address. Educating patients. When I was diagnosed with glioblastoma, I knew nothing about the disease. I quickly learned from others with brain cancer. Fortunately, I’m now able to “pay this forward,” having become an active and trusted advocate in the brain tumor community. I now regularly receive and respond to requests from people newly diagnosed with glioblastoma or their care partners. They seek information about treatments, about side effects and strategies to mitigate them, and more. They look to connect with someone who has “been there” and to hear a word of encouragement. I find education and encouragement walk hand-in-hand. Newsletters Sign up for First Opinion A weekly digest of our opinion column, with insight from industry experts. [email protected] Educating physicians. Medical students spend an immense amount of time cultivating deep technical knowledge of physiology, pathology, pharmacology, molecular biology, anatomy, and more before selecting a specialized discipline and dedicating several additional years immersed in that domain. Missing from this educational experience is the perspective of the people theyadvertisement Tags advocacycancerfinancepatients Thanks to a surprising and devastating diagnosis, I know more than most physicians about what it’s like to live with the brain cancer known as glioblastoma, everything from self-titrating my anti-epileptic medications to making sure the right ICD-10 code appears on my MRI referrals. As much as I’d rather not have this expertise, I’ve learned that it is extremely valuable for medical students, physicians, people with brain cancer, pharmaceutical companies, and others. I’ve also learned that it is undervalued.Since I was diagnosed 20 months ago with glioblastoma — a disease I share with Sen. John McCain and about 18,000 other Americans — I’ve tried to learn all I can about the disease, its treatment, and how best to live with it. In doing that, I’ve become an expert patient, what some call an e-patient, following in the footsteps of pioneering e-Patient Dave.I and other e-patients have a lot to offer in at least three separate areas:advertisement By Adam Hayden Feb. 27, 2018 Reprints Related: @adamhayden First OpinionI have brain cancer. Drug companies and med schools should be compensating me for my expertise Adam Hayden Don’t get me wrong. I’m not suggesting that volunteer work be eliminated in favor of compensated work. Nonprofit organizations thrive because of the time given by their volunteers. Donor dollars go further when engaged volunteers supplement administrative costs and staff.But medical education and industry should recognize patient contributions through fair compensation, commensurate with the work performed. If a patient delivers a service that a professional might otherwise provide, the patient is entitled to similar compensation.Expert patients offer value when it comes to medical education or the development of medical devices and drugs. It’s time for them to get the compensation they deserve for improving the health care experience for everyone.Adam Hayden lives with his family in Indianapolis. He blogs about living with brain cancer on Glioblastology, frequently lectures at medical schools, is an advocate for and member of the patient advisory committee for the National Brain Tumor Society, and serves on the executive board for OurBrainBank, a patient-driven platform to help people with glioblastoma better manage their diseases.last_img read more

Surgeon general’s wife treated for melanoma recurrence as he highlights risks of tanning

first_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. By Andrew Joseph March 28, 2018 Reprints Surgeon general’s wife treated for melanoma recurrence as he highlights risks of tanning About the Author Reprints Surgeon General Jerome Adams on Wednesday said that his wife, Lacey, who was treated for melanoma years ago, had experienced a recurrence and was undergoing surgery for metastatic melanoma. He said he was choosing to highlight their story as a way to raise awareness about the risk factors for the skin cancer.In a Facebook post, Adams outlined how exposure to ultraviolet rays from the sun or tanning beds can increase the likelihood of melanoma and described the warning signs. He said Lacey Adams used to tan frequently. What is it? Log In | Learn More Unlock this article — and get additional analysis of the technologies disrupting health care — by subscribing to STAT+. First 30 days free. GET STARTED General Assignment Reporter Andrew covers a range of topics, from addiction to public health to genetics. Health center_img What’s included? Surgeon General Jerome Adams with his wife, Lacey, and daughter, Millie, at his 2017 swearing-in ceremony. Susan Walsh/AP @DrewQJoseph Andrew Joseph 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] Tags cancerpolicylast_img read more

Why does my health insurer sabotage my efforts to manage my diabetes?

first_img Please enter a valid email address. Privacy Policy Reed Saxon/AP @kylahgklinge “At least I don’t need glasses,” I joked to my then boyfriend, now husband. He was just starting to look at medical schools. I’d be his first patient.advertisement Related: Related: It was type 1, an incurable autoimmune disease. A packet I was handed in the hospital outlined how every part of me — nerves, heart, brain, skin, all — would be damaged by the excess blood sugar scraping through my vessels like microscopic shards of glass. I was told I would have to endlessly count carbohydrates, test my blood sugar, and inject insulin to prevent the disease’s serious complications and early death. I was told that this would be a lifelong effort. In the ‘diabetes belt,’ a small town grapples with growth of the world’s largest insulin maker First OpinionWhy does my health insurer sabotage my efforts to manage my diabetes? A few years ago, my pump, which provides round-the-clock insulin, failed without warning. The silent lack of the vital hormone had rapidly and unexpectedly driven me into diabetic ketoacidosis, a dangerous state in which the body burns fat for fuel, creating a wellspring of acid that rose into my chest, even while my blood sugar remained normal.From an emergency room cot, I watched a mass of hazy figures form just beyond my bay. “Non-compliant diabetic,” a doctor said to his team, glancing at me from the hall.My husband, a surgery resident by then, overheard as he was rushing in. “Not her fault,” he corrected. “She just needs help.”Especially against a backdrop of relentless effort to stay healthy, the assumption of culpability can sting. But the issue is much more important than feelings, especially now. We’re on the cusp of a true revolution in diabetes, with the emergence of artificial pancreas systems that “close the loop” between an insulin pump and a glucose monitoring system. They represent our best shot at exponentially easier and longer lives. In a raw crypt beneath Our Lady of the Conception of the Capuchins church in Rome stretches an exuberant display of skeletal remains. The piled skulls, fanned hip bones, and arched spines — remnants of centuries of Capuchin friars — bear a warning. Printed on a sign in three languages, it reads: “What you are now, we once were. What we are now, you shall be.”I was studying abroad when I faced and promptly buried that grim exhortation in a lemon gelato. I was athletic, healthy, and 21. Surely I would never be them. My body was mine to control.But two years later, just before my college graduation, odd symptoms began to surface: blurred vision, fatigue, an insatiable thirst. I hoped I might just need glasses, but the diagnosis came with the swift lance of a finger to measure the sugar in my blood: 900. “You know you have diabetes, don’t ya, dear?” the nurse said.advertisementcenter_img “It’s disheartening to have an insurance company literally sabotage my efforts. It’s horrible that they’ll cover an ambulance ride, eye injections, or kidney dialysis, but not the things that will help me avoid them.” “We’ll figure it out,” he said.And we did. We learned how to tap bubbles out of insulin, how to calculate boluses of this vital hormone, how to count carbs, and more. Nearly 15 years later, it’s been more than 30,000 finger pricks and 1,700 site changes for my inserted insulin pump. It’s been waiting — for low blood sugars to rise, for high blood sugars to fall. It has been worry and strength. It has, by providence and by work, been otherwise good health so far.I knew it would be hard. I did not know it would feel, sometimes, like sprinting in water. But what I never would have believed is how fiercely I have to work to get the chance to fight at all.Even with good insurance, I’ve spent more hours untangling the inscrutable details of my policies over the years than I’d want to tally, just like so many others with chronic illnesses. I’ve come to understand medical versus pharmacy benefits, limitation overrides, essential health benefits. When my insurer denied coverage of the number of test strips I needed to maintain good control of my blood sugar, it took endless calls and a deep dive into the policy’s write-up to uncover what I was due. When my insulin pump tubing kept detaching in the middle of the night, I had to track down the vice president of quality assurance — unearthing his email from a posted company memo — to get it replaced.Those of us with type 1 diabetes are lucky to be living now in a country where we have access to these medicines and technologies at all, of course. And it may seem trivial, this time spent on hold, asking for managers, delving into tiny text. We all do this sort of thing, after all, with various services and businesses — cellphone providers, airlines, cable companies. But there is something deeply galling about toiling for the right to stave off the loss of your limbs and eyesight. These hours are precious when you have a chronic disease that already takes too many of them.I’m the first to admit that I am fortunate. Diabetes groups and message boards are full of stories of people who are denied basic care or the technologies to help them manage their disease, of drained bank accounts, of rationing. Even with the Affordable Care Act’s essential protections, nearly 1 in 4 chronically ill insured Americans are denied prescribed treatments. Insulin prices are soaring. People with diabetes spend more than $9,000 a year on caring for their disease.I’ve met people with diabetes who are forced to string out their use of lifesaving insulin, to forgo glucose testing, to skip the treatments and screenings required to stay healthy. Some have died doing this. Newsletters Sign up for First Opinion A weekly digest of our opinion column, with insight from industry experts. “It’s disheartening to have an insurance company literally sabotage my efforts,” a friend with type 1 diabetes recently messaged me. “It’s horrible that they’ll cover an ambulance ride, eye injections, or kidney dialysis, but not the things that will help me avoid them.”These restrictions are about the growing demands on an imperfect health care system. They are about money. But it seems they’re also about the boundary between the healthy and ill, the us and them, the blameworthy and faultless.Scholars have shown that treating the chronically ill as “others” — deviant or different from the “normal population” — directly informs health care policy. During last year’s health care debate, from the frank denial of coverage for pre-existing conditions in the House’s version of the bill to the Senate’s back door into the same, the current of “othering” was there. Republican Rep. Mo Brooks of Alabama captured the zeitgeist when speaking on high-risk pools: “They will reduce the cost to those people who lead good lives,” he said.That kind of vanity can infect even those charged with our care. Tags diabetesinsurance Leave this field empty if you’re human: In some ways, however, these miracle technologies make us more vulnerable than ever to how we are seen and what we are granted. Coverage restrictions — sometimes almost nonsensical ones — already abound for less costly technologies. More fundamentally, basic coverage of those with pre-existing conditions is once again threatened. Where does that leave us?Health care is hugely complex, and addressing its shortcomings is a Herculean task. But in that effort, it seems stunningly myopic to trust that less care and more profit will mean that people with diabetes and other chronic illnesses will figure it out, somehow, on our own.If we have to scrounge even harder for every ounce of our care, we will be more ill, more expensive, less productive, less alive. People with type 1 diabetes need a real cure. In the meantime, we need access first to insulin and second to transformative technologies without a fight.I am grateful. I am hopeful. I am fearful. I remember the hubris: Those bones are them; this body is you. I know its self-protective power. Maybe you need to teeter on the edge between to know its lie.Kylah Goodfellow Klinge is a biomedical communications consultant whose clients include diabetes treatment and research organizations. Kylah Goodfellow Klinge About the Author Reprints By Kylah Goodfellow Klinge June 19, 2018 Reprints More state lawmakers are pushing transparency bills for diabetes drugs last_img read more

Seeking reform, a neuroscientist argues against ‘sexist’ beliefs that keep research focused on male animals

first_img But some are concerned that the NIH’s mandate and even experiments that pay more attention to female models might reinforce the idea sex is the only way to explain biological differences.“It’s just important for us to not repeat the idea that sex is the ultimate variable that’s going to explain everything,” said Rebecca Jordan-Young, a sociomedical scientist at Barnard College. “The way sex actually relates to multiple other variables across animals is not the same [as in humans].”With the Ambien example, for instance, some recent research has suggested that it may be body size and not necessarily sex that’s behind why some people may need a different dose of the drug.Shansky agreed that sex isn’t the only variable. Even the strain of rat that a researcher uses can influence the results. “I do not think ‘rat strain as a biological variable’ is something NIH will add soon, but those are things worth thinking about when scientists choose experimental design,” Shansky said.Because these basic biomedical studies do carry weight in the real-world, she said, it’s ultimately important to be careful about variables and pay attention to any differences that they bring.“What we hope is that the things that work their way out into the actual world and into translational-level studies are the things that are really robust effects and that shouldn’t necessarily be so sensitive to things like sex,” Shansky said. “If it’s going to work in a human, maybe it should work in more than one strain of rat.” Shraddha Chakradhar Leave this field empty if you’re human: Shansky also suggests instead that researchers, especially in neuroscience, start with an equal number of male and female animals and conduct their experiments without the assumption of sex-based differences. If differences emerge that suggest that sex could be a variable, then the scientists could follow up with larger studies examining each sex more closely.“I think the suggestion that one needs to have an equal number of females and males and do statistical analysis to find outliers is a good one,” said Catherine Dulac, a Howard Hughes Medical Institute investigator and neurobiologist at Harvard University. “People have to get used to having sex as a variable — for many studies I bet it won’t matter and for some I bet it will.”Dulac also said that the NIH’s mandate may not be going far enough, since there is no requirement to use female animals — it only asks researchers to account for sex in some way.“The problem is that [researchers] are going to think about it for 30 seconds to say why they can’t use female mice,” Dulac said. “You hope that they have that tinge of guilt [from not using female mice] because the situation is really becoming unbearable.”Another way forward may be to focus on the next generation of scientists. “There’s shaming, and there’s training,” Dulac said. “I think training is the way to go forward.”Nicole Woitowich, associate director for the Women’s Health Research Institute at Northwestern University, agreed, saying there may be resistance from current scientists.“With folks who are set in their ways, I just don’t know that they are going to change their practices,” she said. “Training is our best hope for changing our attitudes towards sex and gender-inclusive research.” @scchak Please enter a valid email address. Trending Now: Her research also found that the perception that variability only exists in female mice may not actually be rooted in fact. A 2014 meta-analysis of some 300 mouse studies found that physiological, behavioral, and other biological measures in male and female subjects did not vary much regardless of the estrous cycle. Another such analysis from 2016 looked at rat studies and found similar results.“If you think that females are more variable than males, that is not based in reality,” Shansky told STAT. “That is based on your perception of what you think ovarian hormones do to a female animal, and that’s sexist.”In a statement Thursday, Chyren Hunter of the NIH’s Office of Research on Women’s Health refuted the validity of the idea that female hormones are more variable than male hormones. “The belief that non-human female mammals are intrinsically more variable than males and therefore should be excluded from routine inclusion in research protocols is without foundation and has been refuted in peer-reviewed publications,” Hunter told STAT.In fact, at least one study found that depending on whether animals were housed alone or in groups, males — because of dominance-induced changes — could actually have high variability in testosterone, a variability that Shansky said is not taken into account on a regular basis.Even cortisol, the so-called stress hormone, fluctuates throughout the day. “No one has said you have to do two experiments twice a day, once in the daytime and once in the nighttime, for male studies of drug efficacy,” she said.And even though the NIH’s 2016 mandate was intended to correct for some of this one-sidedness in research, Shansky said that may not be enough. The mandate doesn’t explicitly say how scientists ought to go about including both male and female animals, for instance, and Shansky writes in her paper that this lack of direction means researchers often still go to male animal models first and then try to replicate the findings in the female models. Studying sex differences will improve health for women and men Starting in 2016, the National Institutes of Health mandated that researchers applying for grants factor sex as a variable into experiment design and data analyses. But one neurobiologist argues that outdated gender stereotypes, many of which are not evidence-based, are still finding their way into scientific experiments.In a perspective published Thursday in Science, Northeastern University neurobiologist Rebecca Shansky said that one of the biggest misconceptions among her colleagues and many male and female scientists is that female hormones — and the estrous cycle in mice, which corresponds to the menstrual cycle in women — are “messy” and complicate matters for research.“It seems that we are applying all of these higher standards for rigor to female animals that we haven’t had for male animals, and it’s all essentially based around this idea of ovarian hormones, and that to me just seems really wrong.”advertisement Ambien is an example frequently cited by proponents of sex parity in research. The insomnia drug was approved in 1992, a year before the Food and Drug Administration lifted a ban on women’s routine participation in clinical trials. After reports of dangerous side effects, including women being involved in car crashes due to what’s known as “sleep driving,” the FDA in 2013 required the manufacturer to halve the recommended standard dose for women. Women seem to metabolize the drug more slowly, the FDA said, and that caused the effects of Ambien to stick around until the next morning.And that’s just the most famous example. “Immunology research has discovered that there are differences in how men and women respond to vaccines, and it’s also well-known that symptoms of heart attacks are different,” said Margaret McCarthy, a neuroscientist and pharmacologist at the University of Maryland School of Medicine. “Pretty much at this point, there isn’t a common organ that men and women share that doesn’t have differences.”But beyond the regular inclusion of women in clinical trials, even the inclusion of female animals in research continues to be a problem. McCarthy, who helps review intramural grant applications for the NIH, said one of the common themes is the failure to incorporate sex as a biological variable into applications.“The message is really not getting out nearly as well as it should,” McCarthy said.And so Shansky wanted to investigate the origins of what she calls a “dogma” about female hormones being inherently problematic for clean, uncomplicated research.Her research took her to Victorian times, when the idea of women being unstable and at the whim of their emotions had a stronghold in the scientific community.“This perception that women are emotional and hormonal was sort of a deliberate narrative, constructed in the Victorian era by biologists and psychologists to essentially preserve the patriarchy,” Shansky said in the conference call. As a result, basic research — unless it sex-specific research — has largely used only male animal models. Results from these studies form the foundation of more rigorous clinical trials, and ultimately lead to drugs that are used by both men and women.“I would hope that if a researcher considers their research to be clinically relevant, then they would want it to be clinically relevant for everyone and not just men,” Shanksy said in a conference call this week with reporters.advertisement Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day. Male doctors said my ‘female’ cancer was incurable. Then a woman took command and gave me hope center_img Privacy Policy Tags research Related: In the LabSeeking reform, a neuroscientist argues against ‘sexist’ beliefs that keep research focused on male animals [email protected] Related: Adobe Reporter, Morning Rounds Writer, Intern Coordinator Shraddha writes the Morning Rounds newsletter and covers health and medicine. By Shraddha Chakradhar May 30, 2019 Reprints About the Author Reprints Comparing the Covid-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson last_img read more

Experts parse Biogen’s Alzheimer’s data: Does the treatment work, or is it a mirage?

first_img Ruby Wallau for STAT Biotech 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? Log In | Learn More What is it? By Sharon Begley and Damian Garde Oct. 23, 2019 Reprints @damiangarde About the Authors Reprints Beyond the grabby headlines, punchy tweets, and stock market bounces, Biogen’s surprise resuscitation of a once-doomed treatment for Alzheimer’s disease drew a hefty dose of caution — and even some skepticism.The basis for Biogen’s decision was a re-analysis of data from late-stage studies of its drug, aducanumab. Those data, the company said, showed the treatment reduced the rate of patients’ cognitive decline. @sxbegle GET STARTEDcenter_img National Biotech Reporter Damian covers biotech, is a co-writer of The Readout newsletter, and a co-host of “The Readout LOUD” podcast. Damian Garde Senior Writer, Science and Discovery (1956-2021) Sharon covered science and discovery. Sharon Begley 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. Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED [email protected] [email protected] Experts parse Biogen’s Alzheimer’s data: Does the treatment work, or is it a mirage? Tags agingbiotechnologyBostondementiaSTAT+last_img read more