Biden to lead cancer task force in bid for ‘phenomenal’ progress

first_img Biden unveils road map for his ‘moonshot’ against cancer But the researchers acknowledged that they had a ways to go. Even the most promising therapies, they said, might work in only one-third of patients. The challenge now is to figure out how to make it work for everyone else. They’re still deciphering whom the therapy will help, how to combine it with standard treatments and how much of a dose to give.Biden came to Penn three months after he first called for a moonshot to end the disease, a statement he made when he announced he would not run for president in 2016.In the last few months, Biden has met with 200 researchers, advocates, and other figures involved in the cancer fight, according to his aides. He hasn’t gotten to the nitty-gritty of explaining exactly what he’ll do during his last year in office, but he has emphasized the need for greater investment in cancer research, and a cultural shift that encourages collaboration among scientists.Researchers who met with the vice president’s staff last week said they lobbied for a national open-data initiative and for the federal government to spend more money on gene sequencing, saying those are obvious steps that could be taken in the short term.Biden picked Penn for his first major public event after the State of the Union because of the school’s work on immunotherapy, according to his staff. Beau also earned his undergraduate degree here, as Biden pointed out during Friday’s event.Dr. Carl June and other top researchers here have produced breakthroughs in treating advanced blood cancers with the therapy, and several faculty members have since started a pharmaceutical company to develop more.In the days leading up to Biden’s visit, Penn researchers were clearly enthused by the tacit endorsement of the vice president, but also cognizant of the expectations it brings. Some in the field have criticized Biden and Obama for saying they want to “cure” or “end” cancer, and previous high-minded efforts haven’t produced the panacea that such rhetoric would suggest.Biden acknowledged those concerns Friday, saying at one point that he almost wished he “hadn’t called it a moonshot.” But he argued that the potential is there for transformative progress — and he said he would dedicate the rest of his life to it. Biden, shown with NIH Director Francis Collins, wants the government to be “partners, not impediments.” Joseph Kaczmarek/AP By Dylan Scott Jan. 15, 2016 Reprints A presidential cancer moonshot (again)Volume 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/2016/01/15/biden-cancer-task-force/?jwsource=clCopied EmbedCopiedLive00:0001:1001:10  Presidents have been promising to cure cancer for 45 years, but cancer is still very much with us. Alex Hogan/STAT “My commitment is not for just the next 12 months,” he said. “I plan on doing this for the rest of my life.”Friday’s event was the kickoff for Biden’s public work on the cancer effort. He’s also heading to Davos, Switzerland on Sunday to discuss the latest cancer research developments with international experts. Related: PoliticsBiden to lead cancer task force in bid for ‘phenomenal’ progress Tags cancerJoe Bidenmoonshotpolicy Related: PHILADELPHIA – Joe Biden’s cancer moonshot is starting to take shape.President Obama will soon order an executive action creating a task force, led by Biden and putting every agency in the federal government at his disposal, the vice president said Friday at the University of Pennsylvania. It was the first public event Biden has held since Obama announced a national commitment to end cancer in his State of the Union address and placed Biden in charge.“We can change the life circumstances of millions of people around the world,” Biden said, pounding the table. He was joined by some of Penn Medicine’s leading cancer researchers in a small room at the school’s huge medical complex. “This is the place the United States can make a contribution that exceeds anything we’ve done so far for humanity.”advertisement 7 ways to tell if ‘cancer moonshot’ is legit, or political rhetoric Biden emphasized that this was not some massive new federal program. Instead, he saw the task force’s role as figuring out how the government “can be partners, not impediments.”But Biden also made it clear how much the effort means to him after the death of his son, Beau, from brain cancer last year. And he said his work on cancer isn’t going to end when he leaves office next January.advertisement A major theme of the roundtable discussion that Biden led with a dozen researchers, which lasted more than an hour, was his desire to bridge gaps between different research institutions, as well as the pharmaceutical industry.Researchers urged the vice president to press the drug companies to make their clinical trial data more readily available to others. They also want him to encourage them to allow their drugs to be used in combination with products from other companies in trials.“That could be a huge contribution of this venture, to get that data out there,” said Dr. Francis Collins, director of the National Institutes of Health, who sat beside Biden during the event.The NIH, the Food and Drug Administration, and the Department of Defense are some of the agencies that Biden said would be crucial to the effort. On the data front, the National Cancer Institute expects to launch its Genomic Data Commons — a project to gather and distribute cancer genomics data — in the next six months, Dr. Douglas Lowy, NCI’s acting director, said during the meeting.Biden spoke more than once about the need to sell the public on investments like fiberoptic cables that can carry the huge datasets that researchers say will help them make discoveries faster. One common refrain he said he heard when talking with people about big data was: “What the hell does that have to do with fighting cancer?”As for treatment, the researchers spoke of the promise of immunotherapy, which uses the human immune system to fight cancer cells — including for glioblastoma, the cancer that took Beau’s life. In the audience was Emily Whitehead, a young girl who was cured of her leukemia by the therapy.In the longer term, 10 years from now, the researchers said they hope to be able to create a cancer vaccine that would help prevent and stop the mutations that become cancer in the first place.“You’re on the cusp of some phenomenal breakthroughs,” Biden said, calling it “an inflection point” for treatment, a favored phrase among researchers.last_img read more

Former pharma exec headed to trial on kickback allegations

first_img Related: Between 2009 and 2012, W. Carl Reichel allegedly orchestrated a campaign to give doctors money, free meals, and phony speaking fees in exchange for prescribing medicines sold by Warner-Chilcott, where he had been the president of the pharmaceutical division, according to federal prosecutors.Next week, he goes on trial in what is expected to be a closely watched case in the pharmaceutical industry. That’s because the case marks one of the relatively few instances in which federal prosecutors have sought to hold a high-ranking executive from a drug maker accountable for such activities.“To the extent the executive is convicted, it will impact the industry,” said Anne Walsh, a former associate chief counsel at the US Food and Drug Administration who is now a director at Hyman, Phelps & McNamara, a law firm that specializes in regulatory matters.advertisement There is now a “more uniform, systematic, and sustained focus on individuals,” said Sally Yates, a US Deputy Attorney General at a New York City Bar Association meeting last week. She originally issued the DOJ memo.“There is one system of justice — one in which wrongdoers can and must be held accountable based on facts and evidence, not on position or title, power or wealth,” she said.The emphasis on individuals also emerges after a drop-off in the number of settlements that the Justice Department has reached with drug makers for illegal activities, such as paying kickbacks to physicians or illegally marketing medicines. From a high of 18 deals in 2013, which capped a rising trend, the number of settlements fell to 11 last year, according to data compiled by Public Citizen.In the Reichel case, the feds allege that he developed and oversaw an illegal strategy to boost prescriptions for several drugs, including the Actonel osteoporosis treatment and the Doryx acne medicine. Among the charges: Reichel provided sales reps with unlimited expense accounts in order to wine and dine doctors, and he suggested targeting doctors who were already frequent prescribers, according to the indictment.He faces no more than five years in prison, three years of supervised release, and a fine of $250,000. We asked his attorney for comment and will update you accordingly.“I think the Justice Department needs and wants to send a signal,” said Patrick Burns of Taxpayers Against Fraud, a nonprofit that that advocates for tough penalties and is partially funded by attorneys. ”I hope this will become a larger effort to bring personal accountability to corporate suites, because if they bring pain to the executive, it will bring change to the corporation.” To be sure, other drug company executives have faced penalties for illegal activities. Notably, three former executives at Purdue Pharma pleaded guilty in 2007 to misleading the public about the risk of addiction posed by the OxyContin painkiller. They were also banned from any dealings with federal health care programs, notably, Medicare and Medicaid.But such instances are relatively rare in the pharmaceutical industry, even as a parade of drug makers has paid large fines for civil and criminal violations. Moreover, the Reichel trial gets under way just eight months after the US Department of Justice issued a memo that serves as a blueprint for pursuing individuals who engage in corporate malfeasance.advertisement Leave this field empty if you’re human: At the time that Reichel was indicated last fall, Allergan, which now owns Warner-Chilcott, agreed to plead guilty to health care fraud and pay $125 million to resolve criminal and civil charges in connection with illegally promoting several drugs, according to the settlement.Three former sales managers — Timothy Garcia, Landon Eckles, and Jeff Podolsky — also pleaded guilty for directing sales reps to access confidential patient data after insurers denied coverage for the drugs. The company sought the patient data in order to submit what are called prior authorization forms, which refer to specific requests made by doctors to insurers to provide coverage for a medicine.They each face no more than 10 years in prison, three years of supervised release, and a fine of $250,000. Their respective sentencings will not occur until between July and September. By Ed Silverman May 17, 2016 Reprints PharmalotFormer pharma exec headed to trial on kickback allegations APStock Newsletters Sign up for Pharmalot Your daily update on the drug industry. @Pharmalot center_img Privacy Policy Please enter a valid email address. [email protected] Ed Silverman Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. About the Author Reprints Former sales rep for opioid drug maker pleads guilty to kickbacks Tags Allerganbribeskickbackslast_img read more

Health experts offer their support for — and skepticism of — the cancer moonshot

first_imgLet’s be honest. There’s not that much money in the moonshot. I just don’t think it is going to have that big an impact. We’ve already got a lot going on in cancer. More than 800 drugs are in cancer clinical trials. That’s really where we should be focused.Risa Lavizzo-Mourey, president and CEO of the Robert Wood Johnson Foundation:The cancer moonshot evokes a very positive time in American history, a time when we were able to harness our collective will and brainpower and resources.We have so much information that is not being harnessed. A lot of the progress will be accelerated by better sharing of information.One thing I hope the moonshot will address is the racial disparities that exist in cancer care: lack of access to insurance, which then leads to later diagnoses; the absence of screening; insurance that may prohibit some people from getting the most sophisticated diagnostic tests or treatments. In situations where you can remove some of those disparities, the outcomes are nearly identical, at least between blacks and whites.Eric Lander, president and founding director of the Broad Institute of MIT and Harvard:We aren’t going to be curing cancer in 10 years. But there’s nothing wrong with putting down ambitious markers and organizing our thinking together. The more we ramp up attention on something like cancer, the more creative we’re all going to get.Dawn Laguens, executive vice president and chief experience officer at Planned Parenthood:We need to go after cancer, which has devastated so many lives, so many families. What I would like more resources for — and what we have seen a push for — is the HPV vaccine, which can help prevent a variety of cancers in women and men.Robert Califf, commissioner of the US Food and Drug Administration:The FDA will play a huge role in the moonshot.Many of us believe that cancer is at an inflection point right now with the ability to target therapy using genomics and immunotherapy at the same time. The investment of not just money but also breaking down barriers to sharing of information could really make a difference.Joe Biden has the resilience and perseverance to talk to people, and has friends on both sides of the aisle. If a cancer moonshot is ever going to work, this would be the time to do it.When asked about the name cancer moonshot, Califf said “No comment” and walked away.Mark McClellan, professor and director of the Duke-Margolis Center for Health Policy at Duke University, and former FDA commissioner and administrator for the Centers for Medicare and Medicaid Services:Making progress on diseases like cancer is partly about discovery. More funding for basic research is important, but progress is also about development. Translating from basic science in the lab to reliable, safe, effective treatments is really hard. One thing I’ve noticed over the years with these big initiatives is that they tend to put the money into basic research, which is important, but there should be a complementary component in what I’d call development science, like setting up big data programs using existing systems of care. The FDA sees every day what goes wrong in development programs. It has programs like breakthrough therapy designation, which provide more resources for helping public and private organizations collaborate. So bring in the FDA and think about development, not just basic research. First OpinionHealth experts offer their support for — and skepticism of — the cancer moonshot Vice President Joe Biden speaks during a meeting of the Cancer Moonshot Task Force. Susan Walsh/AP STAT Ezekiel Emanuel, Vice Provost for Global Initiatives and chair of the Department of Medical Ethics and Health Policy at the University of Pennsylvania:There are four obvious things to do to improve the health of Americans. One, increase the tax on cigarettes. That’ll do more to bring down cancer than any moonshot because it will prevent cancer rather than spending a lot to treat it. Two, we need to get people to exercise more. Three, we need better diets and a tax on sugary beverages, such the one my adopted hometown of Philadelphia recently passed. We will see what the impact is, but it certainly isn’t going to hurt. Four, take some of the money you’d get from a cigarette or soda tax and invest it in home visits for poor women who are having babies. Every child who has a healthy start is a very huge return on investment; it improves their health and school performance.advertisement [email protected] center_img The National Cancer Moonshot Summit, to be held on Wednesday, is an effort by the White House to promote efforts championed by Vice President Joe Biden to find a cure for cancer. At the same time, dozens of associated regional conferences will take place around the country, bringing together scientists, patients, and health care experts.In advance of the summit, STAT reporters and editors interviewed various individuals in the worlds of science, medicine, and health for a sampling of opinion on Biden’s initiative. They range from skepticism to support.The interviews — some of them lengthy, others conducted on the run — were done at Spotlight Health, part of the Aspen Ideas Festival in Aspen, Colo. The comments have been edited for clarity.advertisement By STAT June 28, 2016 Reprints About the Author Reprints Tags cancerJoe Bidenmoonshotlast_img read more

Science’s arbiter of disputes, the meta-analysis, is falling prey to bias

first_imgThe WatchdogsScience’s arbiter of disputes, the meta-analysis, is falling prey to bias Many clinical trials’ findings never get published. Here’s why that’s bad Related: NewslettersSign up for The Readout Your daily guide to what’s happening in biotech. By Ivan Oransky and Adam Marcus Sept. 19, 2016 Reprints (We note, hanging our heads in a moment of self-reflection, that journalists are responsible for some of this. In an attempt to avoid potentially misleading readers, we often value meta-analyses and reviews above individual study results.) Leave this field empty if you’re human: Such “living documents” — suggested in an editorial that accompanies Ioannidis’s paper — would be one solution. Another could be rethinking incentives, so that a high-quality meta-analysis or systematic review would be worth more at promotion time than a bunch of weak ones. “A scientific culture that values methodological rigor, research transparency, and data sharing over rampant productivity will hopefully yield systematic reviews and meta-analyses that are necessary and nonduplicative and that do not compromise on quality,” write Matthew Page and David Moher in the editorial.Other scientists are raising similar concerns about meta-analyses. The scientist-blogger Hilda Bastian, for example, has pointed out that, among other flaws, meta-analyses are prone to positive publication bias because negative findings rarely find their way into print. They’re also a “snapshot in time” that can be — and often are — obsolete by the time they’re published.The solution to this problem is not to dismiss meta-analyses. Rather, as Bastian says, it’s to make more data available by publishing all studies, positive or negative. In a new paper, John Ioannidis, of Stanford University, argues that scientists are being deluged with a “massive production of unnecessary, misleading, and conflicted systematic reviews and meta-analyses.” Rather than present objective evidence, these articles are afflicted with the very illness — assumptions, biases, and wishful thinking — that they ostensibly try to filter out, he says.The surge in reviews — a 2,500 percent increase since 1991, according to Ioannidis’s PubMed analysis — is precisely because of their strength. People pay attention to their conclusions. As a result, “Many scientists now want to do them, leading journals want to publish them, and sponsors and other conflicted stakeholders want to exploit them to promote their products, beliefs, and agendas,” Ioannidis writes in a Q&A about the paper.advertisementcenter_img Please enter a valid email address. To be sure, scrupulous reviews are valuable, Ioannidis says. And his vision is indeed of a field of science where meta-analyses and reviews are the “main type of primary research.”“The problem is that most of them are not carefully done and/or are done with predetermined agendas on what to find and report,” he writes, a major blown chance for scientists to create bedrock in the literature of truly solid results.To fix that, says Ioannidis, we should flip our thinking. “Any new study should start from a systematic review of what we already know (to even justify the need for its conduct and its design) and should end with an updating of what we know after this new study, again in the systematic review framework,” he writes. That could give rise to living documents that change as new findings augment or reverse old conclusions. Privacy Policy APStock Science headlines can be notoriously flip-floppy: One week something causes cancer, another week it protects against it. A cholesterol drug works. Oops, no it doesn’t. Well, maybe it does, a bit.To help prevent whiplash, researchers developed the meta-analysis — a means of combining the data of previous studies into a larger pool to get a better sense of what’s happening. Meta-analyses — and their close cousins, systematic reviews, which take the same approach but stop short of statistical analysis — are considered the pinnacle of scientific evidence, the dispassionate and orderly adults in a roomful of clamoring children.But now one of the leading critics of the quality of biomedical research — who himself has published a number of meta-analyses — says he believes such studies have a problem of “epidemic proportions.”advertisement Tags biomedical researchpeer reviewscientific researchlast_img read more

Trump’s proposed budget would cripple the NIH and FDA

first_imgPolitics Tags cancerpolicyWhite House Ellen V. Sigal Carolyn Kaster/AP Since taking office, President Trump has done right by the scientific and patient communities by placing strong leaders at the Food and Drug Administration and the National Institutes of Health. After a four-month vacancy in the FDA’s top job, Dr. Scott Gottlieb now runs this essential agency, and Dr. Francis Collins is continuing his leadership of the NIH. With these experienced and thoughtful leaders in place, there is reason to be optimistic that the progress promised by the passage of the 21st Century Cures Act in December 2016 will be fully realized.But the president’s newly released budget seems to move in the opposite direction. It would hamstring Collins and Gottlieb in their efforts to protect and improve the lives of Americans and represents a major impediment to bipartisan opportunities to build on the momentum and execute the programs created through Cures Act and the current reauthorization of the Prescription Drug User Fee Act. Unlock this article — plus daily intelligence on Capitol Hill and the life sciences industry — by subscribing to STAT+. First 30 days free. GET STARTED What’s included? By Ellen V. Sigal May 24, 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.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. What is it? GET STARTED About the Author Reprints @CancerResrch Log In | Learn More Trump’s proposed budget would cripple the NIH and FDA last_img read more

While no one says ‘cure,’ the pipeline for ALS treatments looks more promising

first_img Unlock this article — plus daily coverage and analysis of the biotech sector — by subscribing to STAT+. First 30 days free. GET STARTED By Andrew Joseph May 25, 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. APStock Key insight: Several biotech firms, including BrainStorm, AB Science, and Neuraltus, are forging ahead with drugs to treat aspects of ALS. Scientists are hopeful — but cautious.Considering it took more than two decades for a second ALS drug to make it to the US market, you might think that few companies are willing to take the risk of developing such treatments. Biotech 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. While no one says ‘cure,’ the pipeline for ALS treatments looks more promising [email protected] GET STARTEDcenter_img About the Author Reprints General Assignment Reporter Andrew covers a range of topics, from addiction to public health to genetics. Log In | Learn More @DrewQJoseph What’s included? What is it? Andrew Joseph Tags drug developmentneurologySTAT+last_img read more

Can marijuana wean the nation off opioids? This doctor wants to know

first_imgIn the Know 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 Max Blau Sept. 29, 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. GET STARTED What is it? Dr. Chinazo Cunningham has treated thousands of chronic pain patients over the past two decades. Many of them have asked for opioids; they sometimes even request a specific kind of prescription painkiller. But the ones who don’t seek out opioids have intrigued the primary care physician.There’s a common refrain among those patients: Marijuana helped. Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED What’s included? Hyacinth Empinado/STAT Log In | Learn More Can marijuana wean the nation off opioids? This doctor wants to know Tags addictionresearchSTAT+last_img read more

Mr. Quixote goes to Washington? A bill would allow Medicare to negotiate drug prices

first_img Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. Mr. Quixote goes to Washington? A bill would allow Medicare to negotiate drug prices By Ed Silverman Oct. 24, 2017 Reprints Pharmalot Tags drug priceslegislationMedicarepharmaceuticalsSTAT+ What is it? About the Author Reprints Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED APStock In what some may call a quixotic move, a group of Democratic lawmakers on Wednesday will introduce a bill that gives the federal government the authority to negotiate drug prices for Medicare.The bill would allow formulary changes to generate more competition among companies that want preferred coverage for their medicines and also establish so-called fallback prices. These would allow the Department of Health and Human Services to pay what other countries or government agencies, such as the Department of Veterans Affairs, pay for a medicine if negotiations fail.center_img STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. GET STARTED Log In | Learn More Ed Silverman [email protected] @Pharmalot What’s included? Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry.last_img read more

With cures in hand, a major city tries to eliminate hepatitis C — and build a model for others

first_img Related: General Assignment Reporter Andrew covers a range of topics, from addiction to public health to genetics. Her office is Skid Row: A doctor tends to the staggering needs of the homeless SAN FRANCISCO — Just a few years after the introduction of a reliable cure for hepatitis C, this city has launched a campaign built on shoe leather and shrewd epidemiology to eliminate the virus.Health workers are expanding testing and searching the streets for homeless patients who don’t pick up their medication. Clinicians are training more doctors to treat infections. Patients can store their medications at a syringe exchange.It’s all to combat a pressing and growing problem: In the U.S., more deaths are tied to hepatitis C, which can eventually cause liver cancer and failure, than the 60 other top communicable diseases combined, HIV and tuberculosis among them.advertisement [email protected] Dr. Annie Luetkemeyer, UCSF San Francisco’s campaign — called End Hep C SF — is the result of an alliance among health officials, hospitals, advocates, and clinicians to cobble together funding, coordinate care, and combat the stigma of a disease associated with prison, drug use, and unsafe sex.Organizers acknowledge that even if they somehow eradicated hepatitis C in the city, the virus would reappear. But the campaign still aims to dramatically reduce the city’s disease burden — and to become a model for what elimination would require elsewhere.The effort starts with patients like Bill, whose case reflects both the potential of End Hep C SF and the challenges.A homeless man who said he sometimes injects drugs, Bill was sick with hepatitis C for years but never got treated. That changed earlier this year, when his methadone clinic, which previously didn’t treat hepatitis C, found a way to get him the therapy.And yet Bill, who did not give his last name, said his backpack was stolen with a week’s worth of pills during the 12-week course of treatment. Twice.“People are always stealing my stuff,” said Bill, 50, who was using a golf iron as a cane and wore a dark green ball cap with a bedazzled skull.Paulette Walton, a nurse who helps run a hepatitis C program at a San Francisco methadone clinic, shows a pack of pills used to treat the virus. Laura Morton for STATThe bulk of hepatitis C patients are baby boomers, many of whom were infected before the blood supply was screened for the virus. But infection rates, driven by the country’s opioid epidemic, are rising fastest among young people, contributing to more than 19,000 annual hepatitis C-related deaths in the US in recent years. (The virus can remain asymptomatic for years, so health officials believe documented cases and deaths are just a portion of the toll of the virus.)From 2007 to 2015 in California, infection rates increased by 55 percent among men in their 20s and by 37 percent among women in their 20s. In San Francisco, it’s estimated that about two-thirds of the more than 12,000 patients inject drugs. Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day. Matisi had tried to get the new treatments before, but said his insurer rejected the request because he didn’t have severe enough liver scarring yet — an example of the denials that still occur even as the cost of the drugs has come down. He eventually switched his insurance and came to a clinic called Tenderloin Health Services upstairs from Glide. He said it was the rare time when he felt treated as a normal patient, and he was able to get the medication.Informational flyers about hepatitis C resources at Glide. Andrew Joseph/STATAt other places, he said, “You’re kind of afraid to tell them, ‘I use heroin.’ You think they’re not going to look at you like a human and they’re going to blame your for your health problems.”That is a sentiment shared by people who use drugs, advocates say, which is why it’s so important for outreach efforts to meet them where they are.Those places include the 6th Street Harm Reduction Center, where clients come to get clean syringes. In recent months, they have also been able to meet with a nurse practitioner who can prescribe hepatitis C medications. The center has also installed lockers so clients can store their medication.“The only thing they do with regularity is go to the needle exchange,” said Pauli Gray of the San Francisco AIDS Foundation, which runs the center. “People come to us because they’re treated like dirt everywhere else.”The local campaign is possible only because of changes at the federal and state level. The Affordable Care Act, including the expansion of Medicaid, extended health coverage to many more Californians. State lawmakers have approved funding for hepatitis C efforts. And the state’s Medicaid program, known as Medi-Cal, changed its treatment guidelines.Some state Medicaid programs require people to be sober for several months, to get a prescription from a specialist, and to have a certain level of liver damage before being approved for treatment — rules designed to reduce the likelihood that the treatment fails and the chances that a patient gets cured and then reinfected, as well as to avoid draining budgets.Starting in July 2015, however, California shifted its Medicaid policies, aiming to reach “active injection drug users,” as well as men who have sex with men, another group with disproportionate infection rates. The goal is to treat people most likely to spread the virus and thus prevent new cases. Privacy Policy Where hepatitis C rates are seven times the US average — and a cure is kept out of reach “We have the tools to fix it, but hep C numbers are going up. That is really unacceptable.” Newsletters Sign up for Morning Rounds Your daily dose of news in health and medicine. An outbreak waiting to happen: Hepatitis A marches through San Diego’s homeless community Tags addictioninfectious diseaseMedicaidpublic health FDA OKs new drug to treat all forms of hepatitis C Related: Related:center_img The program has helped treat more than 100 patients at the clinic in just over a year. Of the people who completed treatment, there have been two failures and three reinfections, said Dr. Soraya Azari, a primary care physician who sees patients at the methadone clinic.Bill, the patient who had his backpack stolen, was treated as part of a trial looking at ways to improve medication adherence among people who inject drugs. He was able to get his lost medicine replaced and finish his regimen, but still has to wait a few weeks before a final test will determine if he was cured.Patients who are cured at the methadone clinic receive a medal. It’s a small token, but it’s to show them they have accomplished something, and that they should not let the stigma that comes with the disease color their view of themselves, Azari said.“Some people have internalized that shame and guilt, which is so sad,” Azari said. “To erase this disease that came with injecting, it gives people this new self-confidence, this new self-worth, that they are not just their drug use.” Before the development of the latest hepatitis C drugs, which are remarkably effective at curing the disease, the notion of eradication would have been implausible. That is no longer the case. But the virus is now being fueled by drug use, hitting patients who are the hardest to reach and have the least access to care and the pricey medications. Many are homeless, mentally ill, or incarcerated.“Taking the medication is one thing, and it’s not hard on their bodies,” said Katie Burk, the viral hepatitis coordinator at the city’s public health department. “But getting them there, and through the hoops they need to get through, that takes a lot of work.”“People are still getting infected with hepatitis C,” she added. “But what we need to do is outpace infection rates with treatments. If we start every year curing more people than are getting infected, then you can turn that curve around.”advertisement HealthWith cures in hand, a major city tries to eliminate hepatitis C — and build a model for others Andrew Joseph Please enter a valid email address. Related: Leave this field empty if you’re human: “We have the tools to fix it, but hep C numbers are going up,” Dr. Annie Luetkemeyer, an infectious disease doctor at University of California, San Francisco, who is involved with the campaign here. “That is really unacceptable.”One reason, experts say, is because the disease is not a priority. A National Academies panel that recently looked at the feasibility of eliminating hepatitis C held congressional briefings when it released its reports, and almost no one showed up, said Dr. Brian Strom, who chaired the panel.“Congress cares little enough about this disease that they didn’t even send their staffs,” said Strom, the chancellor of biomedical and health sciences at Rutgers.Some places are making treatment and prevention a priority. States including New York and Rhode Island have developed strategic plans, and the Department of Veterans Affairs, with a funding boost from Congress, has moved to treat all veterans, curing tens of thousands already.In San Francisco, the funding for the campaign has been patched together from state grants and local sources; Burk estimated the budget is about $700,000 a year. People in high-risk groups who are cured face about a 10 percent chance of being reinfected within five years, according to some studies. Officials with End Hep C SF are hoping to limit such cases by educating patients about safe sex and by teaching them how long hepatitis C — a particularly hearty virus — can live on a crack pipe or needle.Spending public money to cure people who use drugs and who get reinfected can generate political backlash. But public health experts say that elimination initiatives have to tolerate some reinfections. That’s how you know you’re targeting the people most likely to spread the disease, they say.“A lot of us believe that if you don’t see reinfection, you’re treating the wrong people,” said Shruti Mehta, an epidemiologist at Johns Hopkins, who was on the National Academies panel. “Like, it’s going to happen.”Dr. Soraya Azari and Walton at the methadone clinic. Laura Morton for STATA key part of End Hep C SF has been expanding the number of clinicians who treat the disease. Many primary care physicians still balk at prescribing the new medications, in part because of the specter of the old therapies, which were not very effective and came with atrocious side effects.But now, family medicine and internal medicine residents at UCSF and Zuckerberg San Francisco General Hospital are being trained to treat hepatitis C. Last year, the city’s public health department opened an e-referral platform so primary care physicians in its network can send their patients’ information to a team that then selects which drug to prescribe, based on insurance coverage, the strain of hepatitis C infection, and what other health conditions are present.Since February 2016, more than 400 patients have been treated in the health department’s primary care network, said Dr. Kelly Eagen, a primary care physician.“Not that we’re busting through everybody quickly, but we’re making steady progress,” Eagen said. By Andrew Joseph Nov. 14, 2017 Reprints Privacy Policy About the Author Reprints Leave this field empty if you’re human: Because much of the funding for the initiative has come from grants, it’s possible San Francisco won’t be able to keep up its full efforts.At San Francisco General, the funding has enabled the methadone clinic to hire nurses who manage a hepatitis C program in which patients are evaluated at the clinic and receive their daily pill when they get their methadone dose. But the funding only lasts through June.Paulette Walton, a nurse who helps run the program, said once patients are diagnosed, she sorts out what kind of insurance they have and if they qualify for a clinical trial. She spends much of her time teaching them about reinfection and ensuring patients keep up with the medication.“When they go to jail, we coordinate with the jail,” said Walton, who has a small chalkboard propped up in her office that reads “Happy Day.” “When they go to the hospital, we coordinate with the hospital.”(Patients who have started the regimen can keep taking their medication if they go to jail, but few patients in San Francisco or around the country start treatment while incarcerated.) Bill, a patient whose treatment for hepatitis C was coordinated by the methadone clinic at San Francisco General Hospital. Laura Morton for STAT The money has funded work by community organizations like Glide, which runs a harm reduction center — including a syringe exchange — in the city’s Tenderloin neighborhood. New patient navigators facilitate testing in homeless encampments and single-room-occupancy hotels and help link people who test positive to doctors. So far, they have tripled the number of hepatitis C tests Glide is able to conduct each month.“The hardest thing is when people are not housed,” said Janelle Silvis, one of the navigators. Many homeless people have no problems taking medication, but for others, she said, “that lack of stability makes it really hard to remember to take a pill every day. And like, ‘Where’s my stuff? Can I even hold onto my stuff?’”Health workers also have to convince young, otherwise healthy people with the virus to pursue treatment to begin with. They don’t always recognize the damage the virus is slowly doing to their livers — what Paul Harkin, who helps run harm reduction at Glide, called “the ticking time bomb of hep C.”Walton helps Bill, a patient who completed treatment for hepatitis C, sign paperwork. Laura Morton for STATDoctors who treat hepatitis C said some patients report feeling less fatigued after being cured of the virus, though they acknowledge that might be placebo effect. By getting cured, many people also seem more willing to address other issues, whether it’s starting treatment for a substance use disorder or finding housing.David Matisi, 62, was cured earlier this year after contracting the virus decades ago while in prison, either from injecting drugs or getting a tattoo with a dirty needle, he said. He hasn’t used drugs for almost a year, and he said that being rid of the virus will help him stay clean. He’s now turned into an advocate to support others getting treated.“I want to help others having a hard time or who need help — I can do that,” Matisi said. @DrewQJoseph Please enter a valid email address.last_img read more

LISTEN: Biotech buyouts, CEO breakups, and The Rock does CRISPR

first_img About the Authors Reprints We’ll be back next Thursday evening — and every Thursday evening — so be sure to sign up on iTunes, Stitcher, Google Play, or wherever you get your podcasts.And if you have any feedback for us — topics to cover, guests to invite, vocal tics to cease — you can email [email protected] Why are biotech investors suddenly so exuberant? What does it mean when a CEO scrubs his LinkedIn profile? And can CRISPR turn your dog into a winged hellhound bent on destroying Chicago?We discuss all that and more on the latest episode of “The Readout LOUD,” STAT’s biotech podcast. Stick around for a parsing of merger mania, a history lesson on biotech breakups, and the story of how a sleepy little cancer conference became a multimillion-dollar business. Also STAT reporter Megan Thielking joins us to talk about how Dwayne “The Rock” Johnson has brought gene editing to the big screen, and Adam mentions Four Loko.For more on the topics we cover, here’s the EP Vantage story on M&A; here’s something on a CEO manicuring his LinkedIn; and, most importantly, here’s STAT’s review of “Rampage.”advertisement Damian Garde Senior Writer, Biotech Adam is STAT’s national biotech columnist, reporting on the intersection of biotech and Wall Street. He’s also a co-host of “The Readout LOUD” podcast. By Damian Garde , Rebecca Robbins, and Adam Feuerstein April 12, 2018 Reprints Tags biotechnologypodcast [email protected] center_img The Readout LOUDLISTEN: Biotech buyouts, CEO breakups, and The Rock does CRISPR Adam Feuerstein @damiangarde National Biotech Reporter Damian covers biotech, is a co-writer of The Readout newsletter, and a co-host of “The Readout LOUD” podcast. [email protected] @adamfeuerstein last_img read more