PoliticsBiden staff to cancer researchers: Tell us what we can do quickly A Biden aide declined to talk about the specifics of the meeting, but said the vice president was “using his ability to convene to bring together components of the cancer community, and sees great promise in genomics, immunotherapy, and combined therapies.”One idea that both sides floated during the meeting, which ran 20 minutes longer than planned, was the national open-access data-sharing initiative for scientists and institutions. Biden’s staff was “incredibly interested” in the idea, according to Baselga.“I think we all concluded that perhaps what would benefit the field the most is to build [the] open-access data-sharing initiative,” he said. “We could learn collectively how these tumors behave, what kind of therapies they respond to.”The researchers also told Biden’s aides that they believed the federal government should pay for the next generation of gene sequencing, which could help develop personalized treatments for cancer patients.“These are the things that are feasible,” Baselga said. “They can be done. They would be very impactful.” Related: Biden’s staff was “asking concrete questions,” he said, on how a data platform would be structured and funded.But beyond the minutiae, Biden’s aides were also clearly interested in having the vice president play an aspirational role in the fight against cancer.In May, Biden’s son Beau Biden died of brain cancer at the age of 46.They wanted to know how they could “use the power of both [the vice president’s] personality, as well as the power of what he and his family have been through, as well as the office to move things forward,” according to Dr. George Demetri of the Dana-Farber Cancer Institute, who also attended the meeting.They were interested in “how we can break down silos,” Demetri said, with the data initiative idea being one tangible way to pursue that goal.“I think most of us came away feeling really energized,” he added.Biden’s “moonshot” initiative started with his statement in October, in announcing that he would not run for president, that he wanted the country to pursue a “moonshot” to cure cancer. According to a Biden aide, the vice president and his staff have held dozens of meetings like Friday’s to gather input about how to improve cancer care and research.This story was updated with comments from Biden’s office. Joe Biden’s aides tell researchers they want to find cancer initiatives that could have a quick impact during his last year in office. Mark Humphrey/AP WASHINGTON — Vice President Joe Biden is looking for ideas for his cancer “moonshot” initiative that would have the quickest possible payoff, according to leading researchers who met with his staff on Friday.The questions the cancer researchers got from Biden’s aides suggest that they realize big, breakthrough cancer treatment discoveries could take years — so they’re putting their immediate focus on smaller initiatives that they can actually get done during his final year in office.The researchers suggested two possible quick-payoff initiatives: a data-sharing program that would allow researchers to compare notes on how tumors respond to different therapies, and a federal investment to make new progress in gene sequencing.advertisement “They are on a time crunch,” Baselga said. “They know that there is one year left of his administration. They had a sense of urgency.” Joe Biden pushed Congress for big boost in cancer research funding Joe Biden calls for ‘moonshot’ to cure cancer Tags cancerJoe Bidenmedical researchpolicy Top Biden policy staffers met for 80 minutes in the vice president’s office with scientists from the American Association for Cancer Research. One clear takeaway was that the vice president’s staff is looking for something concrete they can do in Biden’s final year, Dr. José Baselga, the president of the organization and chief medical officer at the Memorial Sloan Kettering Cancer Center’s Memorial Hospital in New York, told STAT.A big part of their message, according to Baselga, was: “Let’s leave aside discovery for a second … This vice president has a year left. What could be done that could be impactful?”advertisement By Dylan Scott Jan. 8, 2016 Reprints Related:
Tags AstraZenecaCrestorgeneric drugs Ed Silverman AstraZeneca sues FDA to prevent generic versions of Crestor A federal judge late Tuesday refused to issue an order that would have blocked several companies from selling generic versions of the Crestor cholesterol pill in the US.The decision is a blow to AstraZeneca, which last month filed a lawsuit against the US Food and Drug Administration in hopes of thwarting generic competition to its blockbuster drug, a $5 billion seller last year. The drug maker claimed the agency was about to illegally broaden the indication for the drug and, as a result, unfairly permit low-cost copycat versions of Crestor.Now, several companies — including Sandoz, Mylan Laboratories, Apotex, Aurobindo, and Sun Pharma — are poised to sell generics. In reaching his decision, US District Court Judge Randolph Moss, who is based in Washington, D.C., rejected an argument from AstraZeneca that it was entitled to seven years of additional exclusivity to sell Crestor in the US market. The FDA, meanwhile, rejected a citizen’s petition filed by AstraZeneca seeking to halt generics.advertisement By Ed Silverman July 20, 2016 Reprints In its lawsuit, AstraZeneca insisted that the FDA’s interpretation of the law would pose a safety risk if applied to Crestor. The drug maker contended that any generic label could render generics potentially dangerous. The drug maker argued that a doctor may still prescribe a generic for HoFH, but choose an incorrect dosage since generic labeling would not contain the same information as Crestor.The US Department of Justice, however, belittled that argument. “This case is not about the medical needs of a small population of pediatric patients with a rare disease,” the Justice Department wrote in court documents. “It is about AstraZeneca’s profit-driven desire to substantially extend its virtual monopoly on one of the world’s most popular medicines.”A delay in generic versions of Crestor may have placed patients at a disadvantage. A recent study in JAMA Internal Medicine found that a six-month delay in the availability of generic versions of the Lipitor cholesterol pill prevented consumers from benefiting from lower out-of-pocket payments. Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. [email protected] As we reported previously, AstraZeneca last May won FDA approval to sell Crestor to treat children with a genetic disorder called homozygous familial hypercholesterolemia or HoFH, which causes very high cholesterol. And thanks to the Orphan Drug Act, the company was awarded an extra seven years of marketing exclusivity, but only for treating this particular rare, or orphan, disease.However, the drug maker maintained that any generic version must include all pediatric labeling information that was approved for Crestsor. And so, facing an expiring patent, AstraZeneca filed its lawsuit over concerns the FDA would, instead, rely on a decision made last year in which generics were allowed to exclude certain information in such situations, so long as a safety risk is not created.That case involved Otsuka Pharmaceuticals, which tried to prevent generic versions of the Abilify antipsychotic. Essentially, AstraZeneca mimicked the Otsuka playbook, which involved filing a lawsuit claiming the FDA was illegally widening the market for the drug and unfairly opening the door to generic competition. Ultimately, Otsuka did not succeed and the FDA approved generic versions. Sanders, other lawmakers urge FDA approval of generic Crestor At issue was a controversial maneuver AstraZeneca used to try to maintain a monopoly on Crestor through 2023. The drug maker accused the FDA of illegally interpreting federal law governing product labeling and sought to prevent the agency from broadening the indication for Crestor. Patent protection for the drug expired earlier this month, which is why the company sought a temporary restraining order.advertisement @Pharmalot About the Author Reprints Related: An AstraZeneca spokeswoman wrote us that the company is disappointed with the ruling, but is “currently assessing” its options. PharmalotAstraZeneca loses court battle to prevent generic versions of Crestor Kirsty Wigglesworth/AP Related:
The WatchdogsFake news invades science and science journalism as well as politics Related: By Ivan Oransky and Adam Marcus Dec. 30, 2016 Reprints Related: From President-elect Donald Trump’s tweets to Facebook fabrications, 2016 has been the year of “post-truth.” Fortunately, we have science to rescue us from fake news, right?Maybe not. Just as some political reporters were taken in by fake news during the election cycle, science journalists also fell for their share of it this year. Examples abound on HealthNewsReview, which rates coverage of medical reporting. These include the breathless and most likely incorrect revelation that actor Ben Stiller skirted death by getting a screening test for prostate cancer. Or Sheryl Crow’s nuance-free and deeply misleading promotion of 3-D mammography for the imaging company Hologic. Or the Cage Match of Credulity, in which Dr. Oz “interviewed” then-candidate Trump about his health, a journalistic farce that redefined the word softball.Science itself never falls victim to this sort of distortion though, does it? We wish that was so. Take, for example, a conspiracy theory about cloud trails from jet planes that was published in a peer-reviewed journal. How about a study linking vaccines to autism long after such a connection had been thoroughly debunked? That one was published in a public health journal. Or this fake news whopper: HIV doesn’t cause AIDS. A peer-reviewed paper made that claim until it was retracted.advertisement There’s a way to spot data fakery. All journals should be using it APStock The antidote is simple — in theory, at least. Scientists need to focus less on pumping out articles and more on producing replicable and robust results. The journalists who cover them, meanwhile, should spend less energy trying to follow the bouncing ball of what the latest data show and devote more time to finding context for those findings. (Just in case you need evidence journalists aren’t always doing that, we have an, um, study about it.)In a thought experiment designed to generate more informative science news, John Rennie, former editor in chief of Scientific American, once proposed a self-imposed “moratorium that forbade writing about new scientific findings until six months after their journal publication.” Rennie’s proposal, which he floated six years ago, was really just a trial balloon. He (and we) think journalists should write about what they want, when they want. But they should also take time to figure out whether the findings are likely to hold up. Journalists who don’t fact-check deserve criticism, whether the topic is politics, entertainment, or science. But the real trouble with fake news is when there’s a kernel of truth in the pile of garbage. That’s especially problematic in science: scientists continue to dress up weak findings in flashy clothes, all the better to publish with. Then their universities often bolster this flimsy work with frothy press releases that journalists fall for.advertisement Come to think of it, that might work for political coverage, too. Instead of posting a story 20 minutes after Trump’s latest tweet, maybe journalists who cover the administration should hold off on their stories until they’ve verified what the new president and his mouthpieces are really saying. (Before our colleagues shout “Not all reporters!” — we know that good reporters already do this.) True, the pace of news would slow down dramatically, but so would the flow of fake stories.That’s an experiment worth testing. Should science fraudsters have to serve jail time? We could go on. But as you’ve gathered by now, science in its current state isn’t exactly keeping us safe from bogus research. Predatory publishers continue to churn out papers for a price, with minimal peer review — or very often no peer review — to vet the results. Unscrupulous researchers use those and other soft spots in the scientific publishing system to get away with presenting wild theories or cooking their data.
Ed Silverman What’s included? @Pharmalot Pharmalot, Pharmalittle: Galena CEO abruptly resigns shortly after probe is disclosed Log In | Learn More By Ed Silverman Feb. 2, 2017 Reprints Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED About the Author Reprints What is it? Alex Hogan/STAT Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. [email protected] GET STARTED 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. Rise and shine, everyone, and how are you today? Puffy gray clouds are hovering over the Pharmalot campus, where the official mascots are happily snoozing and the shortest of short people has left for the local schoolhouse. As for us, we are considering our to-do list and brewing a needed cup of stimulation, since we anticipate another busy day. No doubt, you can relate. So time to get cracking. Here are some items of interest to get you started. Have a wonderful day and drop us a line when something interesting arises …Galena Biopharma chief executive Mark Schwartz abruptly stepped down as chief executive and president — and resigned his seat on the board — on Tuesday, although no reason was given. The move, however, comes shortly after the biotech disclosed a criminal investigation by the US attorney’s office in New Jersey and the US Department of Justice into marketing of its Abstral painkiller. Schwartz had headed the company since 2014. Tags opioidspharmaceuticalsSTAT+
Correction: an earlier version of this article incorrectly referred to Dr. Alvin L. Reaves’ affiliation with Emory University. It is his past employer, not his current one. By Bob Tedeschi April 5, 2017 Reprints Young women with breast cancer learn to celebrate life — and say goodbye Patrick Dillon, a Kent State University communications professor who has researched this topic, said some who opted for hospice care faced accusations of rejecting the “we-take-care-of-our-own” ethos that is common in many African-American families.“It’s caused fractured relationships with friends, family, people in the church,” he said. “There’s a social risk associated with this decision.”Dillon said that physicians who would approach African-Americans about the benefits of hospice care would do well to understand that there are often many more people affecting the decision than are visibly present.Focusing on the idea that hospice is a valuable tool for taking care of a family member — and not an abandonment — may help. It would be even better if the message were echoed by a local clergy member or another trusted member of the community who is not a physician.There’s a growing appetite for ideas like these among black doctors who serve those at life’s end. At a national meeting of palliative care and hospice clinicians in February, Dr. Alvin L. Reaves, of Regional Medical Center in Orangeburg, S.C., organized the first meeting of a group of black professionals, patients, and families in the palliative care community. “So afterwards I asked her, ‘What the hell did I do?’ And she said, ‘Ivan, you were not talking to them. You were talking to your academic staff. You have to come down to the people.’”Turns out, it was much more than just that.Medical researchers who are working to unpack the issue view minority access to hospice care as a matter of social justice. It’s typically paid for by the government, can reduce patient suffering, and relieve family members of the burdens of caring for a dying loved one.Why should African-Americans continue to suffer more at life’s end than others?There’s a lot to sift through, starting with the medical industry’s long and at times ugly history of neglect and abuse of blacks.Doctors can also fail to account for the pervasive belief among many African-American faithful that God has an ability to heal the sick through miracles.Finally, there’s the reality that some in tighter-knit African-American communities can direct harsh judgments toward those who choose hospice. Some see hospice as an abdication of caretaking responsibilities, at best, or, at worst, a hastening of a loved one’s death. (Research actually shows hospice patients live longer than those who opt for more aggressive end-of-life treatments.) At a hospice facility for children, a long goodbye is made a little less lonely EndnotesAgainst a history of medical mistreatment, African-Americans are distrustful of hospice care Related: Armella Leung for STAT Related: Reimagining hospice care — for the living “All of them looked at me with a cold face,” he said. “And then this volunteer takes over for me, stands up, and says, ‘God is good!’ And everybody’s like ‘A-MEN!’” The medical community has long known that African-Americans resist hospice care at far higher rates than other groups. But Dr. Ivan Zama, a hospice and palliative care physician, felt like he could still change some minds when, in 2010, he was asked to address a group of African-Americans at an assisted-living facility in Maryland.Zama, who is black and was born in Cameroon, prepared his most persuasive slides. He enjoyed a warm introduction from a facility volunteer. Then he made his case.Crickets.advertisement Related: Roughly 40 others attended, trading tips about what worked, and what didn’t, in their respective practices.Many things don’t work, Zama said after the meeting.Zama took away some ideas, he said, and offered some of his own.He has, at times, relied on his Catholic background to convince patients and family members that hospice does not run counter to Christian tenets, pointing out that Pope John Paul II chose to die at home without life-extending measures. (Greg Schleppenbach, a spokesman for the United States Conference of Catholic Bishops, called hospice “laudable and beautiful.”)That approach is in keeping with a method that Zama said he developed not long after his hospice presentation debacle. In his second presentation — this time to a different group — he ditched the PowerPoint.“I walked in there and I said, ‘You know, God says that we all have a mission.”He paused, and hoped.“A-MEN!” Zama, who is amiable and fit, with a thick accent, laughs now at the memory.advertisement Tags end of life
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. Despite a never-ending spate of hacking incidents, a majority of drug makers report they feel “more secure” about their computer security, according to a newly released survey.Specifically, 62 percent of pharmaceutical and biotech companies expressed confidence in their security arrangements, and just 14 percent acknowledged they felt less secure, according to the poll conducted last February and March by KPMG, the financial advisory firm. What is it? DAMIEN MEYER/AFP/Getty Images What hackers? Most pharma execs feel secure about their data 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. About the Author Reprints Log In | Learn More Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Ed Silverman @Pharmalot GET STARTED [email protected] Pharmalot By Ed Silverman July 24, 2017 Reprints Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED What’s included? Tags pharmaceuticalsSTAT+
About the Authors Reprints By Brian D. Sites and Matthew A. Davis Aug. 1, 2017 Reprints Brian D. Sites Tags addictionopioidspain Second, we need to develop and put in place health policies and practice guidelines — totally free of influence by the drug industry — that aim to reduce physicians’ dependency on opioids for treating pain. This may involve building infrastructure to routinely offer alternative therapies such as cognitive behavioral therapy, acupuncture, physical therapy, and access to mental health experts.Third, we need to carefully vet policies regarding financial reimbursement for outcomes such as patient satisfaction to anticipate any indirect effects on opioid prescribing.Finally, we need to quickly put in place regulatory policies to identify fraudulent prescribing practices and improve access to drug addiction treatment.Pain rarely kills, though we know of people in chronic pain who feel like it is killing them. But pain pills are actually killing astonishing numbers of vulnerable Americans. If we don’t resolve this opioid problem, thousands more will needlessly die.Brian D. Sites, M.D., is an anesthesiologist at Dartmouth-Hitchcock Medical Center in Lebanon, N.H. Matthew A. Davis, Ph.D., is an assistant professor at the University of Michigan School of Nursing and the Institute for Healthcare Policy and Innovation. First Opinion4 steps to reversing the epidemic of opioid use disorders Paraphernalia for injecting drugs in Huntington, W.Va. Brendan Smialowski/AFP/Getty Images Several historic events led us to this juncture. In the 1990s, multiple professional societies argued that physicians weren’t doing enough to treat people in pain and needed to improve pain management. This advocacy was based on the notion that the current levels of disability related to pain was unacceptable. Based on the educational efforts of major US health systems and leading professional societies, pain came to be thought of, and treated like, a vital sign. In 2001, hospitals were prompted to create pain management standards, including the process of recording patients’ perceptions of their pain in a way that made it easier to assess and treat pain. The results of this social advocacy and regulatory behavior led to a skyrocketing number of prescriptions for opioids. But troubling data emerged from the Centers for Disease Control and Prevention: Despite this increase, there was little to no improvement in Americans’ pain.advertisement Related: STAT forecast: Opioids could kill nearly 500,000 Americans in the next decade Related: Matthew A. Davis This poor correlation between increasing opioid prescribing and health benefits is sadly and starkly contrasted with the tight correlation between increasing opioid prescribing and rising health care expenditures, opioid abuse, overdose, addiction, diversion, and death.While the early advocates for the liberal prescription of opioids are no longer vocal, there continue to be insidious incentives to prescribe opioids. For instance, physician reimbursement is now closely linked to patient satisfaction surveys. There is deep concern in the medical community that overprescribing may be occurring as a function of the desire to optimize patient satisfaction.How do we start to make things better?First, we need to identify individuals who are at high risk for opioid use. Our new research on opioid prescribing found that Americans with mental health disorders such as depression and anxiety, a group that represent 16 percent of U.S. adults, receive more than half of all opioid medications distributed in the U.S. The high use of opioids among this population is particularly concerning because mental illness is also a prominent risk factor for overdose, abuse, and long-term use. [email protected] Health care professionals share a common and lofty goal: to minimize their patients’ pain. But what if we’re hurting more people than we’re helping? That may be the sad reality of the opioid epidemic, one driven in part by doctors’ desire to do good.The use and abuse of prescription opioids like hydrocodone and oxycodone is currently among the most significant health crises today. While Americans account for only 5 percent of the world’s population, we consume approximately 80 percent of the world’s prescription opioids. Overdoses from prescription opioids are the major driver of the 15-year increase in opioid overdose deaths. Overall, prescription opioids are now killing more people each year — 22,000 by last count in 2015 — than die from homicide.Why is the problem of prescription opioids unique to the United States?advertisement A ‘civil war’ over painkillers rips apart the medical community — and leaves patients in fear