8 science questions that could shake up the GOP debate

first_img Tags drug pricesNIHpolicyPresidential campaign By David Nather Nov. 10, 2015 Reprints Senator Marco Rubio has called out some drug companies for “pure profiteering,” and New Jersey Governor Chris Christie has suggested cracking down on price-gouging.Carson, in remarks that have been largely overlooked, told an Iowa audience last month that “there’s a lot of manipulation that is going on” when it comes to drug prices, according to a video released by the Campaign for Sustainable Rx Pricing. Carson added that “these are things that I would be very interested in studying and coming up with real solutions.”Other GOP candidates haven’t dealt much with the issue — or said what they would do about it.Tuesday’s debate could be a chance for the other candidates to say whether they have anything else to offer.VaccinesTo all candidates: Do you believe vaccines are dangerous in any way?Trump was the one who suggested in the September debate that vaccines cause autism, and Carson gently corrected him. But then he, Trump, and Senator Rand Paul all expressed concern that the frequency of vaccinations poses a threat to children — an argument that has also been rejected by medical professionals.If the question comes up again, and the candidates can’t say unequivocally that vaccines aren’t dangerous, they’ll have to endure a new round of criticism from physicians and researchers about their inability to stick to medical science.Medical research fundingTo all candidates: Do you believe the National Institutes of Health should get more money?After years of congressional budgets that have effectively eroded NIH funding by more than 20 percent, researchers are hopeful they might see a boost. It could happen. Jeb Bush has already called for an unspecified increase in funding in his health care plan. But there are also competing pressures for Republicans to prove they won’t allow wasteful spending. Bush nodded to those pressures when he said the agency should come up with a “more robust strategic plan,” eliminate “unnecessary, duplicative research,” and stop funding research on topics like “rabbit massages.”If the question comes up, the other candidates would have to go on the record about whether they support more research funding — and all would have to say whether there are any important strings they would attach.Trump and NIHTo Trump: Do you really think Michael Savage would be a good NIH director?During an October interview, conservative radio talk show host Michael Savage offered himself up to Trump as a candidate to run the NIH — and Trump didn’t knock down the idea. “Well, you know you’d get common sense if that were the case, that I can tell you, because I hear so much about the NIH, and it’s terrible,” Trump told Savage, a nutritionist whose remarks on autism, AIDS, and other medical subjects have previously sparked controversy. A question at the debate would give Trump a chance to clarify whether he was serious — and what, exactly, he thinks is terrible about the NIH.Bush and biotechTo Bush: Why didn’t your investment in biotech pay off?As Florida governor, Bush made a big bet on biomedical research and spent as much as $1.3 billion in state, city, and county funding to turn the state into a research hub. Yet the investment didn’t lead to the job boom he had hoped for, as documented by Reuters and the Los Angeles Times. This is one of the bigger vulnerabilities of Bush’s economic record, so he’d have to come to Tuesday’s debate prepared to answer questions about it.Rubio and drug companiesTo Rubio: How would you separate the “bad actors” from the drug companies that are doing good work?When Rubio made his comments in New Hampshire in October about “pure profiteering,” spokesman Alex Conant later insisted that he was only talking about certain drug companies and that “it is no secret that there are some bad actors who put profits ahead of patients.” But Rubio still hasn’t said exactly what he would do about the problem, and a well-targeted question might force him to explain whether he has a policy solution that would crack down on the “bad actors” without discouraging research and innovation among the rest.Paul and budget cutsTo Paul: A lot of Republicans say it’s time to increase NIH funding. Why did you want to cut it?There’s growing support in Congress to boost NIH’s budget for the first time in years — with key Republicans backing the move — but Paul has been one of the agency’s most consistent critics. In a 2012 budget proposal, he called for reducing NIH funding to 2008 levels, arguing that the private sector also funds research and development. He also rails frequently about NIH-funded studies he considers wasteful, including one about how social relationships among college freshmen can contribute to weight problems. The debate could give him a chance to clarify whether he’s concerned about the overall erosion of NIH funding and what research he considers important.Carson and end-of-life careTo Carson: You have said the government spends excessively on medical care at the end of a person’s life. What should the government be doing differently?Before he was a presidential candidate, a STAT review found, Carson raised provocative questions about whether society should keep spending so much on medical care for the terminally ill, and whether doctors should always prolong people’s lives just because they can. His campaign insists he was raising rhetorical questions, not proposing reforms, but social conservatives are likely to want to hear more about whether such remarks reflect the kind of policies he would advocate if elected to office.Ike Swetlitz contributed to this report. The Republican presidential candidates have already proven that medical science can be a dangerous subject in a debate. Remember the exchange between Donald Trump and Ben Carson about whether vaccines cause autism? Good times.Life sciences issues aren’t likely to be the centerpiece of Tuesday night’s Fox Business Network/Wall Street Journal debate, which is supposed to focus on business and economic issues. But the moderators could very well slip in some questions about medical science and policy — and in doing so, they could help us learn a lot about how the GOP candidates think, and whether they’ve thought about these issues at all. Most of them still haven’t spelled out specific ideas about how they would curb rising drug prices, nor have they said much about their positions on medical research funding.Here are some medical science and policy questions to watch for:advertisement Marco Rubio and the other GOP candidates may have to field questions about medical science and policy during Tuesday night’s debate, which is supposed to focus on business and economic issues. Mark J. Terrill/AP Drug pricesTo all candidates: What would you do about rising prescription drug costs?This is an especially tough one for the Republican candidates because of what they don’t want to do: embrace anything that could be construed as “price controls.” Sure, Hillary Clinton and Bernie Sanders can propose letting Medicare negotiate drug prices. Easy for them to say. The Republican candidates have to be able to criticize the notion of “price controls” — and then think of something else that they would do instead.advertisement Politics8 science questions that could shake up the GOP debate last_img read more

Could financing health care like a home hold down drug costs?

first_img Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Pharma wants more freedom to pitch drugs. A separate review panel could be a problem [email protected] The notion is appealing. After all, making it possible for patients to obtain expensive life-saving medicines could go a long way toward tackling the mushrooming problem of rising drug costs — an issue that’s likely to become even more vexing as pricey personalized medicines become available.But before anyone signs on the bottom line, consider the fine print.For one, some diseases may be riskier than others. Lo’s paper points to hepatitis C treatments as good examples of why such loans are needed. The medicines don’t come cheap — running anywhere from $54,600 to $94,500 for a course of treatment, depending upon the drug and regimen — and some private and public payers are facing lawsuits and investigations for restricting access to only the sickest patients.Yet hep C drugs have been in high demand because they offer cure rates exceeding 90 percent. This is the kind of result that should entice the financial community, since the patient would be more likely to return to health and pay off the loan on schedule. But not every illness is so easily vanquished. This underscores the challenges lenders may face as they evaluate the credit risk of sick consumers.Here’s another concern: If health care loans are guaranteed by the federal government the way that student loans are, the pharmaceutical industry may not feel constrained about pricing. And with more people borrowing money to obtain and pay for more treatments, health care costs could soar when the loan system is intended to do the opposite.As Dean Baker, co-director of the Center for Economic and Policy Research, a left-leaning Washington think tank, pointed out, the loans “may give drug makers incentive to do exactly what we don’t want them to do. And there’s nothing to stop them from trying” to raise prices.Others worry that securitization is problematic, because this is the same mortgage-bundling technique that led to the Great Recession.“I’m not sure these loans would prevent us from more bankruptcies any more than easy mortgages prevented us from disaster in the housing market,” said Arthur Caplan, a bioethicist at the New York University School of Medicine.Lo acknowledged the proposal is only a starting point, and he said he hopes the idea can gain enough traction to eventually convince insurers and government agencies to take on the loans. This weekly column offers opinions on the latest pharmaceutical industry news.Consumers take out loans every day to purchase houses, cars, and college tuition. What if they could do the same for expensive medicines?It’s an idea that a group of Boston-area health economists floated last month in response to the rising cost of prescription drugs. And as envisioned, everyone involved in health care and finance could benefit from the availability of a health care loan.Patients would gain access to needed medicines. Drug makers would gain more confidence their treatments would find a market and generate more revenue that could be invested in research. And by bundling the loans and then reselling them — a financial maneuver known as securitization — banks could create a market to attract and reward investors.advertisement By Ed Silverman March 8, 2016 Reprints “There’s a win-win, but the most important thing is that we would be saving lives,” said Andrew Lo, a health economist at the MIT Sloan School of Management, who proposed the idea of health care loans in the journal Science Translational Medicine.Lo and his colleagues suggest lenders could earn 9 percent on nine-year loans and investors could earn a hypothetical 12 percent annual return from a loan fund. And as a further enticement to consumers, they propose a pay-for-performance mechanism in which a loan could be cancelled if a treatment fails to work and an illness returns before final payments are due.advertisement About the Author Reprints Miguel Medina/AFP/GettyImages With drug costs rising, it’s time for pharma companies to open their books Related: Related: Ed Silverman @Pharmalot Already, some on Wall Street seem open to the notion.“I think it is worth exploring,” said Tom Rutledge, who heads the fixed income group at the Magnetar Capital hedge fund. “The question is how do we make it transparent for everybody involved, and make it a fair market for both borrowers and lenders?”Indeed, more work is needed in order to create a dedicated loan market and overcome legitimate skepticism about mortgaging patient lives. This is a distasteful notion, but perhaps it will spur policymakers into addressing drug costs.If for no other reason than that, Lo and his colleagues deserve credit for putting the issue on the table. The Pharmalot ViewCould financing health care like a home hold down drug costs? Tags drug priceshepatitis Cpharmaceutical industrylast_img read more

Two drug makers complain India is thwarting licenses for selling generics

first_img [email protected] Last month, however, the government issued a brief, but pointed statement saying its policy has not, in fact, changed. Nonetheless, this latest development is worrying advocacy groups, which argue that any moves to discourage Indian drug makers and restrict licenses would hurt patients who are unable to, otherwise, afford medicines. Many of these generics are sold not only in India, but in other countries, as well.“We don’t have full details from the companies, but we think this may be a case of external pressure placed on India through bilateral discussions with the United States,” Yuan Qiong Hu, a legal and policy adviser with the Access to Medicines campaign at Doctors Without Borders, told us. “So we are concerned about the broader implications of this case.”One industry analyst, however, suggested the frustration expressed by Lee and BDR is misplaced and may not reflect a move by the Indian government to take a harder line on compulsory licenses. Instead, the situation can be traced to the varying circumstances under which the government can issue these licenses to meet public health needs.“I would not characterize” this skirmish as the result of global brand-name industry influence, said Vince Suneja, chief executive of TwoFour Insight Group, a consulting firm that works with Indian drug makers.He noted that there are two different types of compulsory licenses that India can issue. One stems from a World Trade Organization agreement that allows countries to override patents in the event of a national emergency. But the license sought by Lee was based on commercial reasons that required permission from the Indian Patent Office. Rafiq Maqbool/AP Newsletters Sign up for Morning Rounds Your daily dose of news in health and medicine. Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. The controversy over access to medicines took a twist this week when two Indian drug makers disclosed they would no longer seek government licenses to make generic versions of two brand-name medicines. And they cited pressure from the global pharmaceutical industry on the Indian government as their reason for ending their efforts.BDR Pharmaceuticals and Lee Pharma are not pursuing so-called compulsory licenses that would allow them to make and sell lower-cost versions of drugs made by Bristol-Myers Squibb and AstraZeneca, according to Reuters. These licenses allow generic drug makers to make low-cost versions of brand-name medicines without the consent of the brand-name company holding a patent.Both drug makers had been appealing government rejections of license applications. Lee sought to sell a version of the Onglyza diabetes medicine made by AstraZeneca, but was rebuffed earlier this year, while BDR hoped to market a version of the Sprycel cancer medicine from Bristol-Myers Squibb, although that bid was rejected three years ago.advertisement Ed Silverman India agrees to restrict generic drug licenses, business groups say About the Author Reprints Please enter a valid email address. Brand-name drug makers remain angry over a 2013 court ruling that denied a patent for the Gleevec cancer medicine sold by Novartis. And the US Trade Representative regularly places India on its priority watch list for countries that fail to sufficiently protect and enforce patent rights. In response, Modi formed a “high level” working group on intellectual property after taking office two years ago.Indian officials declined to respond to requests for comment from Reuters, but the decision by these drug makers comes shortly after confusion over the government policy toward compulsory licenses. Earlier this year, two prominent business groups filed documents with the US Trade Representative’s Office suggesting the Indian government had agreed to restrict compulsory licenses. Privacy Policy By Ed Silverman April 13, 2016 Reprints Tags Bristol-Myers Squibbgeneric drugspatents Leave this field empty if you’re human: Suneja explained that the patent officials rejected the application because the company failed to convince them that the needs of India’s diabetics were not being met by the AstraZeneca drug or others like it. Three similar medicines are sold in the country. Moreover, another generic version was already available at a lower price when Lee sought a license.“This is being termed as a public health (need),” said Suneja, “but the provision used by the company to seek a compulsory license requires (those factors and others) to be met, and the Indian patent office determined that these factors were not met.”As for BDR, the drug maker also needed approval from the patent office, but the agency determined the company did not negotiate in good faith with Bristol-Myers for a voluntary license — a required step before filing an application in such instances when a national emergency is not involved. And last June, an Indian court upheld the Bristol-Myers patent.We asked Lee Pharma for comment and will update you accordingly. BDR could not be reached for comment. Related: @Pharmalot But “there is no point in pursuing it anymore,” Dharmesh Shah, BDR’s managing director, told the news service.The companies claim they were thwarted by Prime Minister Narendra Modi and his administration’s desire to boost foreign investment by acquiescing to multinational drug makers. The global pharmaceutical industry has long argued the Indian government has been lax about enforcing intellectual property rights in order to favor its domestic drug makers, many of which sell generics.advertisement PharmalotTwo drug makers complain India is thwarting licenses for selling generics last_img read more

Urine test could simplify Zika virus detection

first_img A medical researcher looks at the results of blood tests for various diseases, including Zika, at the Gorgas Memorial Laboratory in Panama City. Arnulfo Franco/AP HealthUrine test could simplify Zika virus detection About the Author Reprints NEW YORK — A urine-based test for Zika virus infection has shown to be more effective than the common blood-based one for many patients, a development that could make testing for the infection easier.The test could potentially aid efforts to control Zika, which is mainly carried by mosquitoes, as it is expected to spread further into North America in the coming months.“The timing is excellent,” said Dr. William Schaffner, an infectious disease expert at Vanderbilt University.advertisement Related: Map: Zika-affected areas the CDC says pregnant women should avoid Tags bloodCDCZika Viruscenter_img The Centers for Disease Control and Prevention issued new testing guidance Tuesday, saying the virus particles can be detected at higher levels and for a longer period of time in urine than in blood. By Associated Press May 10, 2016 Reprints Associated Press The new guidance will make it easier to test more people for the virus. Until this week, CDC officials have said the best way to detect Zika virus is to test their blood. The blood is analyzed using a sophisticated lab technique that detects a germ’s genetic material.advertisement But health officials on Tuesday reported on an analysis of 66 people in Florida who were tested for Zika using the same detection method but with both blood and urine samples. About twice as many urine samples correctly tested positive as compared to blood samples.What’s more, the test in urine did a good job detecting the virus for two weeks after the onset of symptoms. The test in blood does a good job only for about one week.That’s an important development, Schaffner said.“There’s a much longer window for detecting the virus,” he said.Still, the CDC recommends testing both blood and urine in the first week. And it recommends a different type of blood test, one that detects a person’s immune response to the virus as opposed to the virus itself, if more than two weeks have passed since the patient’s first symptoms.“We are not recommending to replace blood testing. We’re saying to do both,” said Dr. Marc Fischer, a CDC epidemiologist who helped write the guidelines.Zika virus causes only a mild and brief illness, at worst, in most people. Symptoms include fever, rash, joint pain, and red eyes, and they usually last no more than a week. But in some situations, the virus has been linked to far more serious complications.A Zika epidemic has been sweeping through Latin America and the Caribbean. Last year, when Zika outbreaks were being reported in Brazil for the first time, doctors saw a dramatic increase in severe brain-related birth defects in babies born to women infected during pregnancy. After looking at different kinds of evidence, health officials this year concluded Zika causes such birth defects.Doctors also believe — and are trying to establish — that Zika can cause a rare paralyzing condition called Guillain-Barre syndrome.Zika can be spread through sex, bit is mainly transmitted by a certain species of tropical mosquito called Aedes aegypti. That kind of transmission has not yet been seen in the US mainland, but that may change as temperatures rise and mosquito populations boom.The 472 reported infections reported in the 50 states so far all have been people who had traveled to Zika outbreak countries, or their sex partners.Though it’s common for disease investigators to begin looking for an infection in blood, germs can be more diffused in the bloodstream and harder to spot in lab analysis. It makes sense that a germ’s remnants would be concentrated in urine, along with other things the body is trying to excrete, Schaffner said.— Mike Stobbelast_img read more

After a deadly clinical trial, will immune therapies for cancer be a bust?

first_img “We’ve treated hundreds of patients, which is amazing, but hundreds of patients isn’t thousands of patients, so there’s still a lot to learn,” said Dr. Stephan Grupp, an oncologist at the Children’s Hospital of Philadelphia who has investigated Novartis’s CAR-T therapy.But what about the deadly brain swelling? Grupp said that hasn’t been a prominent side effect in any CAR-T data he’s seen, and certainly not a fatal one. Patients getting modified T cells often report neurological side effects like confusion and seizure, Grupp said, but in the vast majority of cases, those are reversible.It’s impossible to say just what happened with Juno’s therapy until all the trial results are available, Grupp said, but so far, he sees no reason to fret about the future of CAR-T.And that tends to be the refrain among scientists, who, being scientists, often take a “We’ll see” approach to evolving science.But over on Wall Street, patience is harder to come by. Both Juno and Kite saw their share prices drop on Thursday as the market grapples with what to make of the latest safety scare.“Investors right now, I think, are kind of — and deservedly — on pins and needles for the next few weeks as the FDA looks at this,” said Brad Loncar, a Juno investor who founded a Nasdaq-traded fund focused on immunotherapy.The fear is that the FDA will take a dim view of the whole CAR-T class, slowing down the progress of each program and forcing companies to delay their expected filings, as Juno already has. Leave this field empty if you’re human: But in the best-case scenario, Thursday’s news presents a Juno-only problem.Before injecting patients with CAR-Ts, oncologists first administer rounds of chemotherapy to clear out underperforming T cells and make way for the genetically modified new ones. Juno’s problem, according to management, is that it added a second chemo agent to its pre-CAR-T cocktail in an effort to amplify results. The three fatalities all came from the double-chemo group, Juno said.That added chemo agent, fludarabine, has been used in other CAR-T trials — including with other Juno products — and has never been tied to fatal brain swelling. Scientists proposing what could be the first human study using CRISPR to treat a disease also plan to use fludarabine to pretreat patients before administering a CAR-T therapy of their own.So, the theory goes, Thursday’s shocking announcement is but a bump in the road for one program at one company, not a fraying fiber that will undo the whole CAR-T hypothesis.And, as scientists say, we’ll see. Juno halts its immunotherapy trial for cancer after three patient deaths A group of killer T cells surround a cancer cell. NIH CAR-T therapies had run into safety issues before, but nothing like this. Now Juno and its rivals — Kite Pharma and Novartis — are facing heightened scrutiny, as no one seems to be able to explain just why this happened and why it won’t happen again.What does this mean for immunotherapy?First, it’s important to understand that immuno-oncology is not a monolith. The first generation of drugs that harness the immune system to fight cancer is already approved by the FDA and is gaining wider use each year.“It’s the biggest discovery in oncology in the last decade or two,” said Michael Schmidt, a biotech analyst at Leerink Partners. No matter what happens with CAR-T therapies, “the promise of immunotherapy is definitely intact.”There are dozens of approaches to immuno-oncology, designed to attack various cancer-related targets and work in concert with existing drugs. CAR-T is just one arrow in a rapidly expanding quiver for oncologists, and even if the field ends up being less revolutionary than scientists once thought, no one is questioning the broader idea of using the immune system to battle tumors.So is CAR-T a bust?Hardly. The field has already generated lots of data in which engineered T cells have led very sick patients into lasting remissions. But the technology is only a few years old, and scientists are still piecing together its safety and efficacy. Related: Privacy Policy Tags cancerclinical trialsimmunotherapy About the Author Reprints Are patient deaths in the Juno cancer trial just a ‘bump in the road’? By Damian Garde July 8, 2016 Reprints Related: BiotechAfter a deadly clinical trial, will immune therapies for cancer be a bust? NewslettersSign up for The Readout Your daily guide to what’s happening in biotech. Damian Garde National Biotech Reporter Damian covers biotech, is a co-writer of The Readout newsletter, and a co-host of “The Readout LOUD” podcast. @damiangarde Immune therapies have been hailed as the future of cancer treatments, with new drugs racking up excellent clinical results by turning the body’s natural defenses on tumors.But Thursday’s news that three patients died in a trial of one such treatment has surprised oncologists and biotech investors, casting doubts on what looked like a blockbuster new approach to fighting cancer.Here’s a rundown on the fatal trial and what it means for the rest of the field.advertisement Please enter a valid email address. What happened?Juno Therapeutics, one of three companies racing to be first to market a new type of immunotherapy, revealed that the Food and Drug Administration put a temporary hold on its lead clinical trial after three deaths related to swelling in the brain.The treatment in question is called a CAR-T, and it’s made by extracting patient’s immune cells, genetically engineering them to seek out cancer’s telltale footprints, and then reinjecting them into the blood.advertisement [email protected] last_img read more

Prescription drug prices rose almost 9 percent in 2016, continuing an ongoing trend

first_img What’s included? STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED 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? Pharmalot Log In | Learn More Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Tags drug pricingpharmaceuticalsSTAT+ Miguel Medina/AFP/GettyImagescenter_img For those debating the cost of prescription drugs, here is still more evidence illustrating how costs are thinning the American wallet — prices rose 8.8 percent last year, which is the fourth consecutive year of overall price hikes that exceeded 8 percent, according to a new analysis. Moreover, this amounts to an annual average price increase of almost 10 percent over the past three years.By comparison, the consumer price index rose 2.1 percent in 2016. GET STARTED Prescription drug prices rose almost 9 percent in 2016, continuing an ongoing trend Ed Silverman [email protected] About the Author Reprints By Ed Silverman May 10, 2017 Reprints @Pharmalot last_img read more

Can a hurricane induce labor? Women in the path of Irma are worried

first_imgBut some clinicians are frustrated that a demand for shelter exists based on a scientific theory that’s only backed with scant evidence.“Hurricanes don’t cause premature labor,” said registered nurse Mary Roberts, director of the Family Birthplace at Memorial Hospital West in Pembroke Pines, Fla., just outside Miami. “It’s like saying, ‘Oh, my God, a full moon! We’re going to have a lot of babies.’ Theorists out there feel there’s a correlation. Do we change our practice because a storm comes by? No.”advertisement HospitalsCan a hurricane induce labor? Women in the path of Irma are worried Dr. Jonathan Schaffir, associate professor of obstetrics and gynecology at Ohio State University, believes there’s a lot of “folklore” surrounding patterns in nature that may induce labor. In this case, he said the idea of a woman’s water breaking is often compared to a balloon that pops when the air pressure is too low. But he doesn’t buy the theory, because it fails to make sense from a physiological perspective.“I’m not sure I’d actually believe that,” he told STAT. “Unlike a balloon that’s exposed to the air, the amniotic sac is protected inside a uterus that is not as prone to changes from environmental pressure.”Even still, some hospitals standing in Irma’s path — including ones in Fort Myers, Miami, and Pembroke Pines — will open their doors to women facing high-risk pregnancies. Each hospital system has slightly different rules for sheltering expectant mothers. But since most require women to be pre-registered to eventually give birth there, clinicians say it’s an easy decision to extend such services to make their patients feel safe, even if medical care is unlikely to be required.A service, but not a hurricane shelterSix hours before Hurricane Irma makes landfall — an event projected to occur sometime Sunday morning — officials at Jackson Health plan to let expectant mothers seek shelter at three of its hospitals so long as they meet one of the following criteria: they are carrying more than one baby and are at least 34 weeks into their pregnancy, enduring placental implantation abnormalities at least 28 weeks into pregnancy, or experiencing preterm labor. The offer of shelter comes even though one longtime obstetrician affiliated with Jackson has claimed in past interviews that he’s never seen a connection between atmospheric pressure and women going into labor in his more than two decades of practice. (A Jackson spokesperson declined to make him available for comment.)Memorial Healthcare System spokesperson Lourdes Rodriguez-Barrera said three of its hospitals will also let pregnant women shelter in the lobby starting Saturday afternoon if they are within two weeks of their due date or are deemed “high risk.” Roberts notes that “almost everyone thinks their pregnancy is high risk” but the hospital has a specific definition that includes expectant mothers who are older than 35 years, are morbidly obese, or who expect twins or triplets. By Max Blau Sept. 8, 2017 Reprints A surgeon’s secret: As she operated on babies’ birth defects, a doctor hid her own diagnosis Frank Rumpenhorst/AFP/Getty Images Trending Now: Related: Comparing the Covid-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson The phone has been ringing off the hook at Memorial Hospital West. Scores of pregnant women are calling — some crying; others panicking — all asking the same question: Can we stay there during Irma?Many of Florida’s hospitals are built to withstand hurricane winds in order to protect patients. While most don’t act as emergency shelters, some make exceptions for expectant mothers facing high-risk pregnancies. They allow them to inflate mattress inside their walls, provided they bring their own sheets and snacks, in case they enter labor.The reason is rooted in the idea that low barometric pressure induces labor. The debate has fascinated local reporters for years: Back in 1992 the Sun Sentinel reported that at least 1,500 women were hospitalized during Hurricane Andrew. A handful of studies — including a 2007 retrospective study published in the Archives of Gynecology and Obstetrics — further suggests there’s a connection between low barometric pressure and the likelihood that fetal membranes will rupture.advertisement These offers of shelter are inevitably draining hospital resources. Roberts, for her part, is now tracking 200 pregnant women who want to come to her hospital. She has 20 beds in her neonatal unit.“Unfortunately the media makes it utterly chaotic — newscasters this morning said, ‘If you are pregnant, get to the hospital,” Roberts said. “Because of the fear produced, patients [have the wrong] expectations. They come in wanting a bed, wanting a private room. We offer them space in the lobby.”Roberts said the “community service” that Memorial Hospital West is offering should not be mistaken as a form of medical treatment, but seen as a way to offer future patients peace of mind. But as a letter posted in the hospital reminds everyone else: “We are not a hurricane shelter.”last_img read more

Criminal prosecution for violating HIPAA: an emerging threat to health care professionals

first_imgHere, “knowingly” is defined as using a unique health identifier or obtaining or disclosing protected information without authorization. Unless the disclosure meets one of the privacy rule’s exceptions, a violator can be subject to robust penalties. HIPAA turns 20: It opened the door to better doctor-patient communication Related: HIPAA turns 20: Five things you should know about your medical records First OpinionCriminal prosecution for violating HIPAA: an emerging threat to health care professionals BRENDAN SMIALOWSKI/AFP/Getty Images @HinckleyAllen Newsletters Sign up for First Opinion A weekly digest of our opinion column, with insight from industry experts. About the Authors Reprints [email protected] Practice managers and other compliance staff need to make sure that all clinical and nonclinical employees get HIPAA training each year about what constitutes personal health information, best practices for the use of secure communication systems in discussing personal health information, and how to respond appropriately to requests for this information from patients’ family members, news media, or other third parties.Practitioners should also exercise extreme caution before sharing personal health information with commercial third parties. A wide array of them — payers, accountable care organizations, researchers, and billing companies — seek access to provider-held personal health information. To be safe, it’s best to first talk with a compliance professional or legal counsel before to responding to their requests for personal health information.Criminal prosecutions under HIPAA, together with the relatively broad range of conduct for which health care organizations and their staff members may be liable under its privacy rule, require practitioners to constantly be aware of their HIPAA compliance. And remember: Ignorance of the law does not limit an individual’s liability.Anne M. Murphy, Esq., is a partner in the health care group of Hinckley Allen. Laura B. Angelini, Esq., is a partner in the company’s government enforcement and white collar defense group. Jared Shwartz, Esq., is an associate in the company’s health care group. In September 2017, Aegerion Pharmaceuticals agreed to pay more than $35 million to resolve criminal liability arising from HIPAA violations stemming from activities of its sales force. In a related prosecution in February 2018, a Georgia pediatric cardiologist pleaded guilty to disclosing protected health information about his patients to a representative of Aegerion Pharmaceuticals. This April, a Massachusetts gynecologist was convicted of violating HIPAA in connection with the Warner Chilcott action for giving a company representative access to patient information. Both the cardiologist and the gynecologist face maximum penalties that include one year in prison and a $50,000 fine as a result of their respective HIPAA violations.These actions reflect the growing trend of federal agencies leveraging HIPAA’s criminal penalties to obtain guilty pleas and successful prosecutions of providers who are supposed to abide by the law. These incidents also reflect the federal government’s willingness to prosecute HIPAA violations at every corporate level — nonsupervisory employees, management, and corporations themselves — a trend we expect to continue.Proving criminal liabilityAn individual violates HIPAA if he or she engages in prohibited conduct — meaning knowingly obtaining or using HIPAA-protected information without authorization. Here’s a key point: Ignorance of the law does not limit an individual’s liability. In guidance issued to the Department of Health and Human Services, the Department of Justice’s Office of Legal Counsel said that an individual needs to have only “knowledge of the facts that constitute the offense.” In other words, individuals risk criminal prosecution for activity that violates HIPAA even if they aren’t immediately aware that their actions are prohibited under the law. Leave this field empty if you’re human: The penalties for criminal violations of HIPAA are substantial — generally a fine of up to $50,000 and up to one year in prison. A violation of HIPAA committed under false pretenses, such as disclosing a patient’s information for a reason the provider knows to be untrue (such disclosing a patient’s protected health information on the premise that the patient is an imminent threat to the public when the provider knows this to be false), can carry a fine of up to $100,000 and imprisonment for up to five years.The penalties are even greater for violations committed with the intent to sell, transfer, or use identifiable health information for commercial purposes, personal gain, or commercial harm. They can carry a fine of up to $250,000 and imprisonment for up to 10 years.Precautions for health care professionalsThe uptick in federal enforcement actions, along with the stiff penalties, underscore the need for health care providers to establish protocols for preventing and responding to the unauthorized disclosure of protected health information.At the very least, providers should maintain all patient privacy and confidentiality-related policies (such as notices of privacy practices and authorizations to disclose patient information) in writing and review them regularly to make sure they are addressing trends in federal agency interpretation and enforcement of the law.We recommend maintaining these policies in writing for several reasons. Doing so ensures that patients are advised of their rights, allows patients to provide written authorization to release information for purposes other than treatment (such as releasing medical information to an insurer or employer), and is a way for providers to demonstrate to regulatory authorities that they are taking appropriate measures to keep patients informed of their rights under the privacy rule. @HinckleyAllen Privacy Policy [email protected] In 2014, a Texas hospital employee pleaded guilty to accessing personal health information with the intention of using it for personal gain. He was sentenced to 18 months in prison. In 2015, a former district manager of Warner Chilcott, a pharmaceutical company, pleaded guilty to wrongfully disclosing identifiable health information. He was sentenced to one year of probation and fined $10,000; Warner Chilcott paid $125 million in 2016 to resolve its criminal and civil liability.advertisement Anne M. Murphy Laura B. Angelini The term “HIPAA violation” can conjure up images of large-scale data breaches. But health care providers need to be aware that, in the midst of the federal government’s increased focus on fraud in the health care sector, the privacy rule of the Health Insurance Portability and Accountability Act (HIPAA) is an emerging source of criminal liability. Prosecutions for HIPAA privacy violations are on the rise, possibly because they can be far easier for federal prosecutors to prove — and less conceptually complex for a jury to understand — than schemes involving kickbacks, misbranding, or false claims.In essence, the privacy rule establishes uniform national standards to protect individuals’ medical records and other personal health information. It requires safeguards to protect privacy and sets limits on what — if anything — can be disclosed without a patient’s OK.The elements for demonstrating criminal liability under the privacy rule are straightforward, making violations easier for prosecutors to prove. Any provider who violates the privacy rule by knowingly using or obtaining individually identifiable health information or discloses it to someone else may be punished by a fine, prison time, or both.advertisement Please enter a valid email address. [email protected] @HinckleyAllen Jared Shwartz Related: By Anne M. Murphy, Laura B. Angelini, and Jared Shwartz July 2, 2018 Reprints Tags legalphysicianslast_img read more

Russian bots are taking aim at U.S. public health

first_img Second, we need to pay closer attention to public health measures that generate fear among those they are intended to protect, like vaccinations for children or fluoridated water.Third, we must pay special attention to areas in which the West is widely seen as “winning” compared to Russia — in this case public health — making them targets for disinformation campaigns.Looking ahead, what can we do to thwart future dezinformatsiya attacks? The federal government must take the lead on alerting the media and the public to the risks of purposefully misleading disinformation attacks. Public officials, including President Trump, must show a greater dedication to truth and facts. Whenever a prominent public official espouses support for baseless science, it helps those trying to subvert democracy. By relying on a swamp of bogus science, Russia has exploited loving parents with false, misleading, and dangerous information.The federal government needs to work with the tech community to develop programs and algorithms to detect threats to our vital health information infrastructure from harmful lies about public health. Once such attacks are detected, Americans must work together to erect cyberwalls to thwart them. Just as the Trump administration this week belatedly authorized sanctions against any government engaged in electoral interference, similar authority must be deployed to protect public health. It’s time to call out and punish Russia for these attacks in terms it will understand, including trade sanctions and freezing it out of our business and financial markets.Our Constitution makes clear that providing for our common defense is a solemn obligation for government. But our military alone is no longer enough to do this. We now need cyberdefenses to protect our national safety — and our public health.David Beier is managing director of Bay City Capital. Andrew Sullivan is a founding partner of Hudson Pacific. Matt Rourke/AP Measles sweeps an immigrant community targeted by anti-vaccine activists First OpinionRussian bots are taking aim at U.S. public health Comparing the Covid-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson Even though there is a strong, well established, peer-reviewed, and tested body of evidence that vaccines are safe, undermining Americans’ belief in the safety of vaccines has huge implications for public health.Vaccines save lives. According to the CDC, over the last 20 years, vaccines have prevented more than 300 million illnesses, more than 20 million hospitalizations, and more than 700,000 deaths. Reducing vaccination rates would endanger lives. It almost makes sense, in a most devious way, that the Russian government used a disinformation campaign to try to sway the 2016 elections. That campaign has been front and center in many news cycles. But a disinformation campaign that has garnered little attention was aimed at the public health of the United States.This week we learned that nearly 600 Russia-linked Twitter accounts broadcast disinformation aimed at seeding dissent and confusion about insurance coverage under the Affordable Care Act. This campaign not only sought to exacerbate political tensions, but it was also implicitly aimed at depressing enrollment in viable health insurance coverage.Even more frightening is a health-related Russian disinformation effort as insidious as anything we saw in the 2016 presidential campaign. This effort, to create doubt among Americans about the effectiveness of vaccines, was described in an article in last month’s American Journal of Public Health.advertisement About the Authors Reprints Trending Now: That report revealed that Russian agents, using online software applications known as bots, have worked since at least 2015 to create a false impression of surging skepticism about the safety of vaccines. Twitter was the principal channel of attack. The coordinated campaign used tweets to suggest that American public opinion on vaccine safety was equally divided, when it really wasn’t. There’s evidence that these efforts may be working. A recent Research America survey shows a 10 percent drop between 2008 and 2018 in the number of Americans who believe vaccinations are crucial to public health, although the Centers for Disease Control and Prevention hasn’t detected an equivalent decline in actual vaccination rates. By David Beier and Andrew Sullivan Sept. 14, 2018 Reprints Andrew Sullivancenter_img The attack should come as no surprise, since Russia has practiced the dark art of disinformation — дезинформация or dezinformatsiya in English — since at least the 1920s. In a foreshadowing of today’s attacks, in the 1980s Russia launched a campaign to sow confusion in the U.S. about AIDS, falsely claiming that the U.S. military had created the virus that causes this disease. This effort, known as Operation INFEKTION, was cooked up in East Germany and would have been well-known to Russian President Vladimir Putin, who was once a KGB agent.advertisement Vaccines rely on something called herd immunity, which means that at least two-thirds of the target population must be immunized for the vaccine to succeed in reducing or preventing the spread of a disease. With most of the population vaccinated against a particular disease, it has a difficult time getting a foothold. The fewer people who are vaccinated against a particular disease, the lower the likelihood a vaccine program will work.We believe there are three things the U.S. can learn from the disinformation campaign on the safety and effectiveness of vaccines.First, we’ve learned that the Russians operate from a playbook that links seemingly disparate events. In the case of both AIDS and vaccine safety, they exploited pre-existing cynicism among groups or individuals outside the mainstream, planting doubts without apparent Russian links. For vaccines, Russians exploited a controversial report in the Lancet (that was later retracted by the journal) to exacerbate skepticism of vaccine safety so more parents would decline to vaccinate their children. (To be sure, the article had already generated home-grown anti-vaccine sentiment in the U.S.) Related: Related: [email protected] Russian bots were used to sow divisions on vaccines, researchers say @baycitycapital [email protected] David Beier Tags public healthVaccineslast_img read more

A growing number of states are eyeing laws to prohibit a controversial cost-sharing tool

first_img What is it? What’s included? By Ed Silverman April 4, 2019 Reprints Adobe [email protected] A growing number of states are eyeing laws to prohibit a controversial cost-sharing tool STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. About the Author Reprints Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Over the past 10 days, Virginia and West Virginia became the first states in the U.S. to adopt laws that preclude certain health plans from using copay accumulators, a new weapon against widely used but controversial copay assistance cards that drug makers distribute to consumers.The laws, which cover individual and small market plans, come as a growing number of health plans and employers embrace accumulators to blunt rising drug costs. About 30% of employers have adopted them and another 21% are considering doing so over the next couple of years, according to the National Business Group on Health, a nonprofit. Wal-Mart and Home Depot are recent examples.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. Log In | Learn More GET STARTED Ed Silverman @Pharmalot Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Pharmalot Tags drug pricinglegislationpharmaceuticalsSTAT+stateslast_img read more