Why the FBI and Pentagon are afraid of this new genetic technology

first_img About the Author Reprints By Sharon Begley Nov. 12, 2015 Reprints In advance of the panel meeting, one scientist said he was asked about a recent story in a London tabloid. This summer, the Daily Star — known for headlines like a “reality babe who flashes everything” — warned that the terrorist group ISIS is using gene drives to make “supercharged killer mosquitoes.”Experts regard that as unlikely. But the idea that gene drives pose a biosecurity threat is anything but. Because the technology to create a gene drive is widely accessible and inexpensive, biologist Kevin Esvelt of the Wyss Institute for Biologically Inspired Engineering at Harvard University warned the scientific panel at an earlier meeting, “We have never dealt with anything like this before.”advertisement A powerful new genetic technology could eliminate scourges such as malaria and rid entire countries of destructive invasive species. But officials from the FBI to the Pentagon to the United Nations bioweapons office, STAT has learned, are concerned about the potential of “gene drives” to alter evolution in ways scientists can’t imagine, and even offer a devastating new tool to bioterrorists. Now they are scrambling to get ahead of it.The Pentagon’s shoot-for-the-moon research-funding arm, DARPA, though enthusiastic about the potential benefits of gene drives, is studying approaches that could halt them if they went out of control and threatened ecological havoc.A special agent from the FBI’s Weapons of Mass Destruction Directorate, which works to prevent nuclear, chemical, and biological attacks, is scheduled to brief a scientific panel in Washington next week that is advising the government on how to regulate gene drives. The bureau declined to comment on its interest in the technology.advertisement [email protected] Gene drive is a molecular technique that slips a new gene into an organism and guarantees that it will be inherited by offspring and by subsequent generations. That’s possible because gene drive not only introduces a new gene but destroys competitors of that gene. Result: even if the genetically engineered organism mates with a partner carrying a different version of the gene, all of their descendants will carry the engineered gene and express the associated trait.Once a few organisms are genetically altered, therefore, the new trait is “driven” through a population.That could be a godsend. Using gene drives to make locusts unable to swarm, to make invasive species unable to survive in their new home, or to make mosquito immune systems destroy the malaria parasite so they don’t transmit it to humans, are just some of the benefits scientists think the technique could bring.But accidents are possible. A lethal gene engineered into a pest species, say, might jump (or, as biologists put it, “horizontally transfer”) into another species that’s a crucial part of an ecosystem.“People are going to have a hard time deciding if it’s safe to introduce gene drive into a wild population,” biologist Allison Snow of the Ohio State University told an earlier meeting of the scientific advisory panel convened by the National Academy of Sciences, which provides scientific advice to the government. “You can’t always predict from a laboratory experiment what will happen in nature.”Next week’s meeting of the panel will focus not on accidents but on the potential for intentional misuse of gene drives. Dr. Amesh Adalja, a biosecurity and infectious diseases expert at the University of Pittsburgh Medical Center, told STAT he was sent the “ISIS is making superkiller mosquitoes” story by the panel to spur his thinking. He will speak about gene drives and “entomological warfare.”With gene drives, he said in a telephone interview, it might be possible to introduce a toxin-making gene into the salivary glands of malarial mosquitoes so that when they bite they transmit not only that disease but also something quickly lethal. The trait would quickly spread to countless mosquitoes. Or perhaps gene drives could make insects “more hospitable” to dengue or other disease-causing viruses, Adalja speculated, or enable them to expand their range, bringing malaria and other scourges to regions far from the tropics.Such genetic engineering has been possible, in theory, for decades. What’s different is this: with earlier technologies evil scientists would have had to slip the dangerous genes into each and every egg or embryo in order to make an individual organism carry it and, probably, do that over and over as the original carriers died out or failed to pass the trait to their descendants. With gene drive, you have to do it only a few times, depending on how quickly a species reproduces. By one calculation, said the Wyss’s Esvelt, using gene drive to engineer a single mosquito out of 10,000 would cause 100 percent of them to carry the new trait within just 16 generations — mere months.Lighting a fireIn a 2014 paper in eLife, scientists led by Esvelt and Harvard biologist George Church called for “thoughtful, inclusive, and well-informed public discussions” about gene drives. They focused on the possibility of well-intentioned uses of gene drives going bad, bringing “unwanted ecological effects” by, for instance, driving invasive species into extinction. That July, 10 scientists, in a paper in the journal Science, called for regulating gene drives, citing similar concerns.Those warnings came before any lab had created a gene drive. When one at the University of California, San Diego, did so, reporting its breakthrough last March, suddenly a theoretical threat was one step closer to reality.That lit a fire under not only the Academy but other expert groups, too.The National Science Advisory Board for Biosecurity, part of NIH, provides advice to the federal government on “dual-use research of concern,” or legitimate studies that could be hijacked for bioweapons. The main focus of the biosecurity board has been on research to make pathogens such as the influenza virus more lethal or contagious. But “we’re all aware of [gene drive] and I expect it will be next up,” a member of the biosecurity board told STAT.The UN office that oversees the Biological Weapons Convention has been briefed on gene drive, said Piers Millett, who worked there for over a decade and is now a bioweapons policy specialist at the Woodrow Wilson International Center for Scholars in Washington.“One of my duties [at the UN bioweapons office] was horizon scanning,” Millett said. He urged the office to get up to speed on the potential bioweapons implications of gene drives.The possibilities for “weaponizing” gene drives range from suppressing pollinators, which could destroy an entire country’s agriculture system, to giving innocuous insects the ability to carry diseases such as dengue, said MIT political scientist Kenneth Oye, who briefed the bioweapons office.Gene drive is particularly worrisome because “it’s not just one or two labs that are capable of doing the work,” Oye said — and the “capable” could include do-it-yourself “garage biologists.”Oye told the Academy panel, “You need to have people probing the security implications [of gene drives] much more effectively” than is now being done. PoliticsWhy the FBI and Pentagon are afraid of this new genetic technology What is a gene drive?Volume 0%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/2015/11/12/gene-drive-bioterror-risk/?jwsource=clCopied EmbedCopiedLive00:0001:4101:41  Sharon Begley Senior Writer, Science and Discovery (1956-2021) Sharon covered science and discovery. @sxbegle Gene drives have the potential to change the genetic makeup of entire populations, like mosquitos that carry malaria. Hyacinth Empinado/STAT Tags bioweaponsgene editinggeneticspolicylast_img read more

Baby born in Hawaii has birth defect linked to Zika virus

first_img Helen Branswell About the Author Reprints Pregnant women urged to consider avoiding countries with Zika HealthBaby born in Hawaii has birth defect linked to Zika virus There have been 26 Zika infections diagnosed in the United States, dating back to 2007, CDC officials said Friday. But all were people who were infected during travel outside the country. However, in late December, it was reported that Puerto Rico had seen a case of locally acquired Zika infection. The infected person had not travelled.The CDC has said the virus is likely to come to the United States. The mosquitoes that transmit it — from the Aedes family — are found in a number of states, especially in the south. Florida and southeast Texas have been identified as areas that are especially vulnerable.“I think the bottom line is, yes, local transmission can occur, particularly in the areas of the southern United States where vector mosquitoes are present. But we don’t expect very large outbreaks,” Dr. Lyle Petersen, director of the CDC’s division of vector-borne diseases, told STAT this week.Petersen said US experience to date with similar mosquito-borne diseases like dengue and chikungunya suggests that facets of the North American lifestyle — living in air-conditioned homes and dwellings with screens on windows and doors — should limit how much the virus would spread here.The little-known virus transmits in a cycle involving mosquitoes and people. A mosquito becomes infected by taking a blood meal from an infected person, then passes the virus on when it bites additional people.It can spread geographically when an infected person travels to a place where Aedes mosquitoes exist or when infected mosquitoes are relocated, for instance, in shipped goods.Zika virus is related to the viruses that cause yellow fever and dengue fever, but triggers much milder illness. As a consequence, it has not been well studied; up until recently, it has not been a scientific priority.But when Brazilian health officials started to realize they were seeing a surge in microcephaly cases, investigations began to point to Zika infection in pregnancy as a possible cause. A few other viral infections during pregnancy, including rubella and cytomegalovirus, are known to sometimes lead to infants born with microcephaly. Related: Senior Writer, Infectious Disease Helen covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development. There is mounting evidence of a link between Zika infection in pregnancy and babies born with microcephaly. James Gathany/CDC via AP It’s impossible at this point to say how long the travel advice will remain in effect, Dr. Lyle Petersen, director of the CDC’s division of vector-borne diseases, said at a news conference announcing the guidance. The situation is too new and too little is known, he said.It is a question, though, that will be asked with increasing frequency as the 2016 Summer Olympics in Rio de Janeiro approach. The Rio Games are slated to run from Aug. 5 to Aug. 21. What is Zika virus?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/2016/01/16/hawaii-baby-zika-virus/?jwsource=clCopied EmbedCopiedLive00:0001:0801:08  Zika virus, which can be transmitted by mosquitos, has exploded onto the world stage in recent weeks. Alex Hogan/STAT While the link between Zika infection in pregnancy and babies born with microcephaly has not yet been proven, mounting evidence supports the theory that there is a connection.Traces of Zika virus have been found in the amniotic fluid from two women in Brazil who were seen to be carrying fetuses with microcephaly during ultrasounds.And this past week, the CDC confirmed it had found evidence of the virus in the brains of two Brazilian infants with the condition who died shortly after birth. CDC scientists also found traces of the virus in placenta samples from two Brazilian women who miscarried fetuses with microcephaly.The CDC’s travel advice suggests that women who might become pregnant and are planning travel to Zika-affected areas should discuss the issue with their doctors. If a pregnant woman cannot postpone travel to an affected area, she should do the same, the CDC said. And in both cases, women should take stringent precautions to try to avoid being bitten by mosquitoes. Late Friday, the agency urged pregnant women to avoid, if possible, travel to 14 countries and territories in the Americas which are currently experiencing Zika virus infections. The locations named are: Brazil, Colombia, El Salvador, French Guiana, Guatemala, Haiti, Honduras, Martinique, Mexico, Panama, Paraguay, Suriname, Venezuela, and the Commonwealth of Puerto Rico. Tags CDCglobal healthZika Virus Everything you need to know about Zika virus @HelenBranswell The baby’s gender and name have not been released. Its mother was living in Brazil last May which — given that the baby was said to have been born recently — would have been early in her pregnancy. Brazil has been experiencing a huge Zika virus infection that began last May, and has seen a startling increase in infants born with microcephaly.“We are saddened by the events that have affected this mother and her newborn,” Dr. Sarah Park, Hawaii’s state epidemiologist, said in a statement. Park said the case underscores the importance of the travel recommendations the CDC issued Friday for pregnant women and women who might become pregnant.advertisement The United States has its first case of an infant born with a serious birth defect possibly as a result of a Zika virus infection during its mother’s pregnancy.Health officials in Hawaii have announced that a baby born recently on Oahu has microcephaly, a condition where the head is smaller than normal. Babies with microcephaly can also have underdeveloped brains, which may lead to lifelong developmental problems.State officials said testing at the Centers for Disease Control and Prevention confirmed that the baby had previously been infected with Zika virus.advertisement Related: By Helen Branswell Jan. 16, 2016 Reprintslast_img read more

FDA chief pushes back against criticism of stem cell treatment regulations

first_imgPoliticsFDA chief pushes back against criticism of stem cell treatment regulations The FDA officials also offered a strong argument for preserving the gold-standard clinical trials that new treatments typically need to pass before being approved. Only those trials, and not anecdotes or patient belief, can show that treatments are safe and effective, they said.Even scientists who have urged caution on stem cell treatments have said the FDA could make it easier for therapeutic candidates to enter clinical trials. But the agency officials stalwartly defended their approach.The notion that their standards for approving stem cell therapies are too rigorous stems from the fact that researchers developing new therapies don’t understand all the pathways available to them, Califf and his colleagues wrote. They said they are committed to getting safe and effective treatments to patients and are willing to work with researchers under the FDA’s programs that can expedite the regulatory process.Interestingly, the programs the authors mentioned include the accelerated approval process that can get drugs to the market before a clinical benefit is demonstrated. Tucked into the 21st Century Cures Act, a 1,000-page bill Congress is considering this week, is a provision that would allow the FDA to grant regenerative medicine products, including stem cell therapies, accelerated approval.In the New England Journal paper, the FDA officials also alluded to the largely unregulated use of stem cells by hundreds of clinics. Those treatments are often offered without evidence that they are safe or work, “sometimes with the claim that they constitute revolutionary treatments for various conditions,” the authors said. Andrew Joseph Leave this field empty if you’re human: In September, the FDA held a meeting about its proposal to regulate those cells as drugs, and in the paper, the officials reiterated their concerns about what some experts have dubbed a Wild West of unmonitored stem cell treatments.Many of the clinics use stem cells from the patients themselves — what are called autologous stem cells. The FDA officials said that while using those cells is typically safer than using donor stem cells, some patients have grown tumors or gone blind after treatments.Such “adverse effects” are probably more common than known because officials can’t track them if they are happening outside of regulated trials — yet another reason they argued for well-conducted studies of potential treatments.“Without such studies,” the officials wrote, “we will not be able to ascertain whether the clinical benefits of such therapies outweigh any potential harms.” So far, studies “have not reliably demonstrated the effectiveness of stem-cell treatments even in some of the most systematically studied conditions, such as heart failure and graft-versus-host disease,” the authors wrote. Plus, it’s not as though the cells are so ingenious that they can be placed anywhere in the body — “whether injured knee cartilage or a neurologic deficit” — and function as needed.advertisement Please enter a valid email address. Excitement for stem cell treatments has been growing as scientists have learned more about how the cells could be coaxed into replacing damaged or dead cells throughout the body, with possible treatment applications for a wide range of injuries and diseases. But for now, the FDA officials said, the excitement is just that, echoing what many stem cell scientists have said about the field. General Assignment Reporter Andrew covers a range of topics, from addiction to public health to genetics. The country’s top drug regulators on Wednesday pushed back on claims they move too slowly in approving new stem cell treatments and sought to temper expectations for the field’s potential to benefit patients, emphasizing the hazards and the unknowns that persist with developing such therapies.“To ensure that this emerging field fulfills its promise to patients, we must first understand its risks and benefits and develop therapeutic approaches based on sound science,” Food and Drug Administration officials wrote in the New England Journal of Medicine. The paper was written by FDA Commissioner Dr. Robert Califf along with Drs. Peter Marks and Celia Witten, the top two officials in the FDA’s Center for Biologics Evaluation and Research.The authors make their argument in the staid language befitting both government regulators and academic journals. But their message is clear: Let’s all take a deep breath on the stem cell hype.advertisement About the Author Reprints [email protected] Related: After criticism from scientists, Congress eases its pursuit of faster stem cell therapies Dr. Robert Califf, the FDA commissioner. Win McNamee/Getty Images @DrewQJoseph By Andrew Joseph Nov. 30, 2016 Reprints Privacy Policy NewslettersSign up for The Readout Your daily guide to what’s happening in biotech. Tags drug developmentpolicyresearchlast_img read more

Pharmalittle: AstraZeneca thinks it found a key to success; more young women fill ADHD scripts

first_img Tags drug pricingfinancepharmaceuticalspharmalittleSTAT+ Pharmalittle: AstraZeneca thinks it found a key to success; more young women fill ADHD scripts What’s included? About the Author Reprints GET STARTED Ed Silverman 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. Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Log In | Learn More Alex Hogan/STATcenter_img By Ed Silverman Jan. 19, 2018 Reprints Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED What is it? @Pharmalot Pharmalot [email protected] Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, as you know, our treasured signal to daydream about weekend plans. Our agenda, for the moment, is rather modest. We hope to catch up on some sundry chores, spend time with our short person, and possibly visit the Pharmalot ancestors. And what about you? This may be a good time to take in a moving picture. For those with a keen sense of discipline, you can self-flagellate by readying your taxes. Or you could catch up on the steady stream of presidential tweets, such as they are. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon …A focus on fewer diseases, along with cuts in labs and staff, has yielded a more than fourfold increase in research productivity at AstraZeneca (AZN), Reuters writes. Why? There was a marked drop in the number of projects started at the discovery stage, with the total falling to just 76 in 2012 to 2016 from 287 in 2005 to 2010. “We’re working on far fewer programs and the probability of success on those programs is going up,” says one AstraZeneca exec.last_img read more

States look to lower drug costs, consider Canadian imports

first_img Associated Press About the Author Reprints MONTPELIER, Vt. — Lawmakers in more than two-thirds of the states are considering ways to reduce prescription drug costs, including importing them from Canada, as they strive to balance budgets without knowing for sure what their government’s share of the tab will be.A total of 87 bills in 34 states of all political stripes seek to save money on prescription drugs, according to the nonpartisan National Academy for State Health Policy. Six of those states are considering bills that would allow drugs to be imported from Canada, where they cost an average 30 percent less than in the United States. Log In | Learn More Tags policy GET STARTED States look to lower drug costs, consider Canadian imports What is it? By Associated Press Feb. 11, 2018 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. Unlock this article by subscribing to STAT+ and enjoy your 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’s included? Politics Spencer Platt/Getty Imageslast_img read more

7 questions to watch after criminal charges filed in the Theranos saga

first_img Jeff Chiu/AP @damiangarde The two chose different paths three months ago, when the Securities and Exchange Commission charged them with massive fraud in a civil case. Holmes immediately settled with authorities, agreeing to pay $500,000 without admitting or denying guilt. But Balwani opted to fight the charges, and he’s due in court later this summer.2. Will Holmes and/or Balwani try the my-ex-duped-me defense?Adding intrigue to the case is the fact that Holmes, 34, and Balwani, 53, were romantically involved for years while they ran the company as a duopoly. According to Wall Street Journal reporter John Carreyrou’s new book about the scandal, they got together not long after Holmes dropped out of Stanford at age 19 to start Theranos in 2003 — and broke up in the spring of 2016, when Holmes pushed Balwani out of the company as Theranos’s troubles mounted.advertisement Tags diagnosticslegal All of which points to the possibility of a tried-and-true defense: I was tricked by my lover.Don’t be surprised if Holmes’s defense tries to point the finger at Balwani, and Balwani’s at Holmes. Meanwhile, a statement put out on Friday from Jeffrey Coopersmith, the attorney representing Balwani, offers an early hint of what Balwani’s defense might look like, painting Balwani as an honest, well-meaning hard worker whose business simply failed. It’s worth noting that the statement doesn’t once mention Holmes, but you can expect that to change.3. What will happen to Theranos?Last we heard, the blood-testing company was working on a technology called “MiniLab” that would test blood drawn the old-fashioned way — with a needle in the arm — rather than the promised finger prick that made Theranos famous. Now, in a move timed with the unsealing of the indictment, Holmes is out as CEO. Her replacement is David Taylor, the company’s general counsel.Taylor is walking into a difficult situation. The company is running out of money, and it debts are piling up. According to the Wall Street Journal, if Theranos can’t turn things around, creditor Fortress Investment Group could seize the company’s assets and force it to liquidate as early as this summer.4. Will there be a reckoning for Theranos’s high-profile supporters?Among Holmes’s most voluble fans were Sens. John McCain and Joe Biden, CNBC star Jim Cramer, and former Secretary of State George Shultz. To date, not one has spoken out against Theranos or recanted his prior cheerleading. But each could face questions about what he knew and when. STAT+: Business7 questions to watch after criminal charges filed in the Theranos saga About the Authors Reprints By Rebecca Robbins and Damian Garde June 18, 2018 Reprints Please enter a valid email address.center_img NewslettersSign up for The Readout Your daily guide to what’s happening in biotech. Leave this field empty if you’re human: McCain spoke highly of the company throughout 2015, promoting Theranos’s work in Arizona and tweeting a photo of himself with Holmes on the very day the Wall Street Journal’s first exposé went to print. The same year, Biden called Theranos’ California facility “the laboratory of the future.” Neither has mentioned the company since.As for Cramer, he hosted Holmes on “Mad Money” the day after the first Journal story, giving her a friendly and uncritical platform to deny the allegations against Theranos. Shultz, now 97, may have the most to answer for, as the Journal’s reporting revealed that after his grandson, Tyler, blew the whistle on Theranos, the former secretary of state repeatedly pressured him to keep quiet.5. If there is a trial, who will testify?Expect the government to try to bring forward as star witnesses some of the former Theranos employees who blew the whistle on the company, including the younger Shultz. Theranos’ investors and partners, some of whom have already sued the company, could also be called to the stand to detail how Holmes and Balwani duped them into parting with their money.The defense, meanwhile, may have a harder time. As the world came crashing down around Theranos, only one voice has persistently defended it: Tim Draper, a storied Silicon Valley investor and a partner at DFJ, has repeatedly spoken up for Holmes and accused the media of unfairly persecuting her. He could serve as a character witness for a defendant who appears to have few remaining friends.6. What new details could be brought to light in a trial?Each new Theranos revelation seems to layer in power, corruption, and celebrity. And a public trial could tease out yet more.Carreyrou’s new book shows that the deception at Theranos began as early as 2006, but a trial could unveil more detail about how far back the deception went. A trial could also shine more light on the lies that Holmes and Balwani told investors about the state of their business and their capabilities of their technology. And it could reveal more examples of the harm that the company’s blood tests sold in Walgreens stores in California and Arizona may have inflicted on patients.7. How much public attention could a trial command?The 1990s brought the O.J. Simpson trial. In the 2000s, it was Ponzi schemer Bernie Madoff. Will this decade’s big court trial be about blood testing?It seems possible. Those other historic trials brought celebrity, wealth, and can’t-look-away coverage — all ingredients that a criminal trial over fraud at Theranos seems poised to deliver. National Biotech Reporter Damian covers biotech, is a co-writer of The Readout newsletter, and a co-host of “The Readout LOUD” podcast. Damian Garde SAN FRANCISCO — Federal prosecutors on Friday filed criminal charges against Theranos CEO Elizabeth Holmes and the company’s former president Sunny Balwani — marking a pivotal turning point in a scandal that has rocked the business world and captivated the public imagination.So, what’s next for the Silicon Valley villains of the moment? Here are seven questions to watch as the case moves forward.1. Will the case go to trial?Holmes and Balwani are facing serious allegations: nine counts related to defrauding investors, patients, and doctors, carrying a penalty of up to 20 years in prison and up to $2.7 million in fines. Holmes and Balwani seem likely to go to trial, though it’s possible one or both of them could avoid the hoopla with a guilty plea.advertisement [email protected] Exclusive analysis of biopharma, health policy, and the life sciences. Privacy Policylast_img read more

The medical community is changing its mind on chronic fatigue syndrome. Why aren’t insurers?

first_img By Steven Lubet and David Tuller July 19, 2018 Reprints By then, Vastag’s condition was grave. In an article he wrote for the Post, he described how his brain had become so sluggish it felt like “someone has poured molasses into my ear, gumming up all trillion synapses.” His vision was blurred, he suffered constant headaches, he could not walk more than a block — and those were the good days. On the bad days, he couldn’t get out of bed. Even moderate physical activity would leave him incapacitated for days. Tags advocacyinfectious diseaselegalrare disease Related: First OpinionThe medical community is changing its mind on chronic fatigue syndrome. Why aren’t insurers? NIH Director Francis Collins and Brian Vastag in 2017. The NIH launched a study seeking answers on chronic fatigue syndrome after Vastag wrote an open letter to Collins in 2015. NIH About the Authors Reprints Privacy Policy The cause of ME/CFS remains unknown. For decades, the medical establishment largely dismissed it as a psychological disorder and attributed the symptoms to deconditioning. But attitudes have shifted in recent years. According to a 2015 report from the Institute of Medicine (now the National Academy of Medicine), it is an organic illness, often triggered by a viral infection, that involves immunological and neurological dysfunctions. People with it experience paralyzing exhaustion, muscle pain, unrefreshing sleep, cognitive problems, and other symptoms. Many are homebound, even bedbound. The cardinal sign is suffering severe relapses after even minimal amounts of activity — a symptom called post-exertional malaise. In the last few years, the National Institutes of Health has increased funding for biomedical research into the illness.The medical establishment may be turning the corner in its recognition of ME/CFS as a serious illness, but the insurance industry remains largely mired in the past. Vastag’s win against Prudential is a hopeful sign that individuals with ME/CFS, many of whom have been turned down for disability benefits under similar arguments, might finally be gaining the respect, sympathy, and support they have always deservedSteven Lubet, J.D., is professor of law and director of the Fred Bartlit Center for Trial Advocacy at Northwestern University’s Pritzker School of Law. He has been living with chronic fatigue syndrome since 2006. David Tuller, Dr. P.H., is a senior fellow in public health and journalism at the Center for Global Public Health at the University of California, Berkeley. Members of the ME/CFS patient community generously donated to a crowdfunding campaign in support of Tuller’s position at Berkeley. Brian Vastag was enjoying a life that many people would envy. At age 41, he had achieved professional success as an award-winning health and science reporter for the Washington Post, covering important stories from around the world. That came to an end in July 2012, when he found himself afflicted by a mysterious and poorly understood illness that ended up sweeping away almost every vestige of his vigorous and productive life. To add insult to injury, he also had to endure a four-year battle with his insurance company to cover his disability claim for the condition he eventually learned was chronic fatigue syndrome.Like many Americans who experience serious health setbacks, Vastag thought he could rely for help on the disability policy he got through his employer. But because there is no widely accepted diagnostic test for chronic fatigue syndrome (also called myalgic encephalomyelitis, often abbreviated as ME/CFS), many of the 1 million or more Americans who have it are ridiculed and dismissed as delusional, hysterical, or suffering from some psychiatric disorder.Vastag’s symptoms initially resembled those of a nasty virus: fever, muscle aches, overwhelming weakness, fatigue, and dizziness that made it difficult to walk or stand. He visited specialists, who ran test after test. They found numerous abnormalities, but none could offer him a satisfactory diagnosis, much less an effective cure. He was finally referred to two experts who confirmed he had ME/CFS.advertisement Please enter a valid email address. With no alternative, Vastag retained two attorneys who specialize in disability issues — Barbara Comerford and Sara Kaplan-Khodorovsky — and sued Prudential. The lawsuit challenged the denial of benefits under the Employee Retirement Income Security Act of 1974, a federal law that sets minimum standards for most voluntarily established pension and health plans in private industry.In assessing Vastag’s claim, Prudential relied on many of the classic stereotypes about ME/CFS. According to court documents, the company required an appraisal of his “psychosocial history and factors potentially related to stressors, academic history [and] patterns of reinforcement” as well as to “potential psychiatric difficulties, such as somatoform tendencies, depression, or anxiety.” The company ultimately rejected his disability claim, maintaining that “the medical data does not indicate any impairment” that would limit Vastag’s ability to perform his job — a point starkly contradicted by his extensive medical records.center_img Related: Why did it take the CDC so long to reverse course on debunked treatments for chronic fatigue syndrome? Steven Lubet In January 2014, 18 months after the onset of ME/CFS, Vastag stopped working and applied for disability. Prudential Insurance Company, which handled the Washington Post’s disability program, denied his claims for both short-term and long-term benefits. Despite the raft of test results that had been included in his claim and the clear evidence of his incapacity to walk around the block, let alone hold a full-time job, Prudential refused to believe that Vastag could be so severely disabled, no matter what his doctors and other national experts on ME/CFS stated.advertisement Leave this field empty if you’re human: Prudential essentially accused Vastag of malingering, declaring that he “stopped working, allegedly due to chronic fatigue syndrome,” and maintained that medical evidence did not support his claim. Most troubling, Prudential revealed that it had attempted surveillance of Vastag but had not managed to observe him in person. Instead, the company conducted “an internet investigation” aimed at disproving his claim.We asked Prudential several times to talk with us about Vastag’s case, but got no response to our questions.Surveillance can be a valid way of exposing false claims in disability or personal injury cases. But the use of surveillance in Vastag’s case — especially given the extensive evidence submitted by national ME/CFS experts — suggests an alarming level of denial about the severity of the illness. There was no evident reason to suspect Vastag of deception other than the diagnosis of ME/CFS.Prudential’s investigation turned up only that Vastag had moved from Washington to Hawaii, which the company falsely characterized as a vacation, and that he had published two short articles in 2014.Dr. Avindra Nath examines Brian Vastag during his participation in an in-house study on ME/CFS at the NIH. Courtesy Beth Mazur U.S. District Judge Katharine Hayden saw through Prudential’s smokescreen. Explaining in her decision that “the exact cause of CFS is unknown, and no laboratory test can directly diagnose it,” she noted that “the objective medical evidence … indicates that even low-level physical activity” required more energy than Vastag could generate. She rejected the opinions of Prudential’s medical reviewers, finding that none of them “demonstrated any expertise in CFS.” Hayden concluded that Prudential had wrongly denied Vastag’s benefits due to its “significant failure to understand the current state of medical knowledge about CFS and its devastating impact.”In forceful terms, the judge rejected Prudential’s arguments and ordered the company to pay up.A few other courts have ruled for ME/CFS claimants, but none with the definitive clarity of Hayden’s opinion. Even so, Vastag’s victory is not yet cause for unbridled celebration. Because disability cases are decided on their unique facts, this decision does not set a legal precedent, and there is no assurance that other judges will reach similar conclusions in future cases. Moreover, Vastag had access to resources — including information, knowledgeable medical care, and outstanding legal representation — that are available to few people with ME/CFS. @davidtuller1 [email protected] David Tuller Newsletters Sign up for First Opinion A weekly digest of our opinion column, with insight from industry experts. NIH launches study seeking answers on chronic fatigue syndrome last_img read more

As the 2020 campaign kicks off, Democrats scramble to prove their leadership on lowering drug costs

first_img WASHINGTON — As they jostle to position themselves for 2020, many Democratic presidential hopefuls have suddenly zeroed in on a narrow policy target: prescription drug prices.Sen. Bernie Sanders called his first press conference since the midterms not to discuss President Trump’s quest for a wall or tout universalized health coverage, but to unveil a proposal to lower drug prices that mirrors one of Trump’s own. Sen. Cory Booker dialed up his own rhetoric to campaign-trail levels, decrying high drug prices as “a stain on the very idea of America.” The House Oversight Committee, too, set drug prices atop its own agenda, scheduling a hearing on that issue that will occur more than a week before it calls former Trump lawyer Michael Cohen to testify. Unlock this article — plus daily intelligence on Capitol Hill and the life sciences industry — by subscribing to STAT+. First 30 days free. GET STARTED Tags Congressdrug pricingpolicy What’s included? 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. Sen. Elizabeth Warren (D-Mass.) Scott Olson/Getty Images Log In | Learn More What is it? Lev Facher 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 @levfacher As the 2020 campaign kicks off, Democrats scramble to prove their leadership on lowering drug costs Politics About the Author Reprints Washington Correspondent Lev Facher covers the politics of health and life sciences. [email protected] GET STARTED By Lev Facher Jan. 11, 2019 Reprintslast_img read more

Why every child should see a black male doctor

first_imgFirst OpinionWhy every child should see a black male doctor These doctors are trying to get more people of color to join their ranks. What some have overcome is startling Related: An unpleasant experience I had many years ago on an airplane initially left me angry. But it has since come to shape my thoughts on race and how increased diversity in the medical profession could influence the way white Americans view black men like me.When I was 20, I boarded a flight from St. Louis to Houston for a trip home from college. The temperature was cool, so like a typical student I was wearing sweatpants and a hoodie. Shortly after finding my seat, a middle-aged white woman sat next to me.We exchanged pleasantries, as strangers on a plane often do. But then, over the course of the two-hour flight, this woman began to belittle me. She criticized the way I was dressed and told me that I didn’t speak well. What stuck with me the most was when she said, “Nobody will ever take you seriously. You’ll never be successful.”advertisement I suspect that she had had limited interactions with black men over the course of her life. Since then, I have come to believe that if more people got to know successful black professionals, outlooks would change.Bias and racism begin to develop in children as early as age 5. As they become aware of race, they make associations based on how people look. Negative parental attitudes can make children wary and judgmental of people who look different from them; the lack of positive minority imagery in the media only adds to the problem.Misperceptions of black men persist among individuals who have little real-world contact with them. I’m willing to bet that when many Americans close their eyes and imagine a black man, what comes to mind may not be the most positive picture. But it should be. The truth of the matter is that most black men are people with normal jobs and lives like everyone else. Yet that’s difficult for people to appreciate if they don’t see them regularly.Being cared for by a black male doctor can help change this narrative. I see this almost every day at work. When children watch their mom or dad speak with me, they see that their parent respects me. The doctor-patient relationship also builds a special trust. I still vividly remember encounters with my own childhood physician, Dr. Nina Miller, a white woman I revere to this day.Unfortunately, the chances of seeing a black male doctor in the U.S. are slim. Black men have historically been underrepresented in the medical profession, comprising only about 2 percent of U.S. physicians. And the number of black male applicants to medical school has not been growing. According to a report from the Association of American Medical Colleges, the number of black male applicants to medical schools was actually lower in 2014 than it was in 1978. About the Author Reprints Dale Okorodudu [email protected] This discouraging trend may have consequences for the health of the black community. A study published last year by the National Bureau of Economic Research found that black men, who have the lowest life expectancy of any ethnic group, are more likely to follow preventive health recommendations when they are seen by black doctors.To reverse the trend of declining black men in medicine, we need to convince more black boys to pursue careers in the field. Several years ago, I launched “Black Men in White Coats” to inspire more of these individuals to consider medicine as an occupation. It is a series of videos featuring black physicians from my medical school, UT Southwestern, and others who shared stories and perspectives on how race has influenced their careers. We hope these testimonials will show young people that with hard work and dedication they can overcome obstacles and become the positive role models our society needs.I wish every child had the opportunity to be cared for by a black male doctor. They would come to trust and respect this person and, early in life, develop a personal and positive relationship with a black man. Maybe then more people would understand that individuals who look like me, no matter what they’re wearing, are likely to be sincere, intelligent, and loving.Dale Okorodudu, M.D., is a pulmonary and critical care physician and an assistant professor of medicine at UT Southwestern Medical Center in Dallas. He is the founder of DiverseMedicine Inc. and the author of “How to Raise a Doctor: Wisdom from Parents Who Did It” (Clovercroft Publishing, 2018). Related: I’m a young black woman. Why do so many people assume I’m not a doctor? I remember asking myself: Is this what people think when they see someone who looks like me?I’ve often reflected on that unusual encounter, wondering what would prompt someone to act that way. Clearly my seatmate saw a young black man in a hoodie as a hopeless failure, not as a person who would become a doctor in a few years.advertisement Adobe By Dale Okorodudu Feb. 25, 2019 Reprints Tags educationphysiciansracelast_img read more

Most people pay less than $5 per month for the drug. But some pay $11,002

first_img Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. A version of this story first appeared in D.C. Diagnosis, STAT’s weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox.WASHINGTON — “Most* patients pay between $0 and $5 per month” for Janssen’s drug Stelara, the chart proclaims. By Nicholas Florko April 17, 2019 Reprints STAT Nicholas Florko GET STARTED Washington Correspondent Nicholas Florko reports on the the intersection of politics and health policy. He is the author the newsletter “D.C. Diagnosis.” [email protected] @NicholasFlorko 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’s included? About the Author Reprints What is it? Most people pay less than $5 per month for the drug. But some pay $11,002 Politics Log In | Learn More Tags drug pricingpharmaceuticalspolicySTAT+websitelast_img read more