Taxpayer money helped create this cancer drug. Should we be able to force the price down?

first_img State measures to slash drug prices face big hurdles A pair of consumer groups has asked the NIH to override the patent on a prostate cancer drug, arguing the medicine is much more expensive in the US than elsewhere. Pablo Martinez Monsivais/AP Related: Related: PharmalotTaxpayer money helped create this cancer drug. Should we be able to force the price down? NIH asked to fight price gouging by overriding drug patents The plea was issued just three days after 50 congressional lawmakers wrote the Obama administration to demand the NIH develop guidelines that would require drug makers to license patents to others in a bid to end “price gouging.” That letter was written by the Affordable Drug Pricing Task Force, which was formed by members of Congress in response to controversy over the price of prescription medicines.They argued the NIH has the ability to issue so-called march-in rights, which refer to overriding a patent. Under federal law, the lawmakers wrote, this allows an agency that funds private research to require a drug maker to license its patent to another party in order to “alleviate health and safety needs which are not being reasonably satisfied” or when the benefits of a drug are not available on “reasonable terms.”As we noted previously, the lawmakers wrote that march-in rights should only be used when “wrongdoing occurs” and that “innovation should not be threatened.” But by issuing guidelines, the lawmakers also contend that the NIH would help drug makers make “better-informed pricing decisions.” Tags drug pricesNIHpatents Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. “In our opinion, it is unreasonable, and indeed outrageous, that prices are higher in the US than in foreign countries for a drug invented at UCLA using federal government grants,” they write in their letter. “As a direct result of the high price charged by Astellas, US insurance companies and other third-party payers have predictably restricted access to Xtandi.” The key patent, by the way, expires in 2027, according to the advocacy groups.Compared with the wholesale price in the US, where a 40-milligram capsule costs $88.48, Xtandi costs $23.46 in Australia, $20.12 in Canada, and $32.43 in Norway. Medicare, by the way, pays $69.41, according to the advocacy groups. Astellas reported that Xtandi net sales were $313 million through the first nine months of 2015, up 73 percent year over year, according to a filing made by Medivation with the Securities and Exchange Commission.advertisement The advocacy groups also cite federal law to maintain that the NIH could authorize generic production of Xtandi, and that such a move would ensure the price drops sufficiently to widen access for patients. But the failure of the NIH to do so has meant that “Astellas is exploiting the weak response of the US to excessive pricing of drugs,” according to their letter.“In this case, all the federal government has to say is that the monopoly will end, if the prices are excessive, and specifically in this case, if the US is paying more than everyone else,” said Jamie Love of Knowledge Ecology International, which focuses on access to medicines, in a statement. “If US residents continue to pay more than everyone else, it is because the federal government wants that outcome, and will do nothing to change it.”But whether the NIH will take this step is uncertain, at best. In 2013, the agency denied a similar petition from advocacy groups, including Knowledge Ecology International, which complained that the price of an AIDS medicine developed with federal funding was out of reach for most patients. At the time, the agency argued that overriding a patent is an “extraordinary remedy.”We asked the NIH for comment and will update you accordingly.As for Astellas, a spokesman wrote us that the company “believes that the price of medicines should reflect the innovation and patient benefit provided, while we also acknowledge that medicines should be accessible to the patients who need them.” He continued that a “significant investment” and “significant risk” was taken to bring the drug to market. The drug maker, he added, remains “committed to working collaboratively” to find ways to encourage innovation and ensure access. @Pharmalot In the latest twist in the battle over prescription drug pricing, a pair of consumer groups has asked the Obama administration to override the patent on a prostate cancer drug, arguing the medicine is much more expensive in the United States than elsewhere. And they maintain that the National Institutes of Health should take this step to help US patients because federally funded research was used to create the drug.At issue is the cost of Xtandi, which is sold by Astellas Pharma and has an average wholesale price in the US of more than $129,000, about two to four times more than what other high-income countries are paying, according to the Union for Affordable Cancer Treatment and Knowledge Ecology International. They sent their letter to the NIH, as well as to the US Department of Health and Human Services and the US Department of Defense.In their view, the Xtandi patent should be overridden because Xtandi was developed at the University of California, Los Angeles, with help from taxpayer dollars — specifically, NIH and Department of Defense grants. They note that one of the chief inventors of the drug was a UCLA professor and the university later licensed the drug to Medivation, a biotech that eventually struck a marketing deal with Astellas.advertisement Ed Silverman [email protected] About the Author Reprints By Ed Silverman Jan. 14, 2016 Reprintslast_img read more

In Puerto Rico, no one fears mosquitoes. With Zika, that’s a problem

first_img WATCH: In a clinic coping with Zika, pregnant women await the moment of truth About the Author Reprints Zika infection during pregnancy is believed to interfere with fetal brain development in some instances; in those cases, babies can be born with microcephaly — smaller than normal heads — and malformed brains.Although scientists have been cautious about confirming a causal relationship between infection and birth defects, the director of the CDC’s division of vector-borne diseases, Dr. Lyle Petersen, told reporters this week: “I don’t think there’s any question about that any longer.”In Puerto Rico, there are already five pregnant women among the 117 people who have tested positive for Zika. The CDC is working on the assumption that nearly 700,000 residents of the island may become infected with the virus before the year is out — vastly more than in the continental United States, where the mosquitoes that transmit Zika are primarily concentrated in the south.The agency’s director, Dr. Tom Frieden, will travel to Puerto Rico next week to assess the CDC’s efforts to help respond to Zika.“There’s going to be infected women. And there might be babies born with developmental problems. So we’re not saying we’re going to eliminate all risk,” Brenda Rivera, Puerto Rico’s territorial epidemiologist, told STAT. “But we have to decrease it as much as possible. We have to do everything in our power to keep those populations safe.”Style over safetyJulimar Rivera, four months pregnant, is among the people public health officials would most like to protect. She’s only 19 and she’s already contracted dengue and chikungunya in her lifetime.“I’m worried that I’ll get bitten and something will happen to my kid,” she said on a recent day as she waited for a government-run Zika information session to begin. “I’m always carrying two bottles of Off.”Rivera might be more attuned to the threat of Zika than most ordinary Puerto Ricans. But she wasn’t wearing light-colored clothes, or long sleeves, or long pants — the standard uniform suggested for avoiding mosquito bites. Her short-sleeved dark olive green dress and bare legs were typical in San Juan, where looking chic can take priority over covering up.Alexandra Santiago, 22, said she knows she ought to wear tops with long sleeves, but until recently she didn’t own any. Pregnant with her second child, she bought some. But that doesn’t mean she always wears them.“Sometimes I do, sometimes I don’t,” Santiago said, noting the heat by way of explanation. “It’s Puerto Rico.”Alexandra Santiago, 22, with her 3-year-old son Sebastian Martinez, speaks with Alejandra Seda, nutritionist and registered dietitian, at the WIC Clinic in San Juan. Santiago is four months pregnant. Erika P. Rodriguez for STATModest weapons to fight the virusHealth officials here have modest weapons at their disposal.Public awareness campaigns are being planned. So too is targeted mosquito control spraying around the houses of women who are pregnant — if that proves to be acceptable to the homeowners.Pregnant women will be given Zika kits — tote bags containing mosquito repellant, a few condoms as a reminder of the risk of sexual transmission of the virus, a bed net, some larvacide pellets to put into septic tanks or standing water, and some pamphlets.Another option under consideration is providing screens for the windows and doors of the homes of pregnant women who agree to let a health department team visit to look for and eliminate mosquito breeding sites, said Dana Miró, executive director of a prenatal health program for women called Woman, Infant, Children.WIC, as everyone calls it, is the vehicle through which many Zika response efforts are being delivered. The agency already provides nutritional counseling, food vouchers, and other assistance to 93 percent of pregnant women in Puerto Rico, so it knows how to reach this population.There are roughly 15,000 pregnant women right now on the island, according to Miró, who added that in an average year, about 29,000 Puerto Rican women are pregnant.WIC has been calling women on its registry and asking them to attend a Zika information session. As of late last week, nearly 5,000 had — but only about one-quarter agreed to let health department staff check their homes for ways to reduce mosquito populations.It remains to be seen if an offer of free screens would improve that rate. Among many Puerto Ricans, there is a belief that screens make homes hotter by impeding air flow, said Dr. Jose Rigau, a retired physician and epidemiologist who lives in San Juan.And the reality is that people don’t have to have swarms of mosquitoes in their homes to catch Zika or its viral cousins. Rigau said a 1990s study showed the risk of dengue infection on the island rose in houses that had as few as two female mosquitoes — the ones that bite — per person. “It’s just two, per person, spread throughout the house. So it’s not like you’re seeing mosquitoes constantly,” Rigau noted.A mosquito that loves the indoorsStill, Aedes aegypti mosquitoes — the species that is known to transmit Zika — love to live inside. In Puerto Rico, they are always around.“We live side by side with them everyday,’’ said Tyler Sharp, the acting head epidemiologist at the CDC’s dengue branch. “Everybody that I know, myself included, has mosquitoes in their home, in their apartment. You do what you can to avoid them. But they are omnipresent.”The challenges in Puerto Rico are significant, acknowledged Stephen Waterman, director of the branch. “There’s been a lot of complacency about dengue here. Obviously, Zika raises a whole other level of fears, but I think there’s a lot of community outreach that needs to be done.”“The chikungunya outbreak in 2014-15 infected thousands of people. And we expect to see the same thing happen with Zika,” he said flatly. “We’re not going to be able to prevent every infection, or every infection in pregnant women. But I think we can probably reduce some of them. And every one of them is worth preventing.”Educational material about the Zika virus at a temporary WIC information location in San Juan. Erika P. Rodriguez for STATA significant challengeIt will take more than informing pregnant women to lower their risk of Zika infection. Neighbors and communities will need to work hard at getting rid of the standing water in which Aedes mosquitoes lay their eggs.Brenda Rivera, Puerto Rico’s territorial epidemiologist, thinks that because the virus threatens babies, people will be galvanized to act. Waterman agrees, noting Puerto Rican culture is very family-oriented.“If we can sort of tap into that sensitivity and concern about making sure that families are safe, that pregnant women are safe, then that may contribute to community participation,” he said.The local media have been featuring stories about Zika prominently. But to date the public awareness campaign — to inform people here of what they can do to reduce the population of Aedes mosquitoes — has not started.Brenda Rivera said the department of health wants to see what that work yields before it commits to public service announcements.“Some of the critical steps, before we put a lot of money into this effort, it’s understanding what in the messages needs to be included,” she said.That’s not an academic exercise. Rigau recalled a public service campaign in the 1980s warning about the risks of dengue hemorrhagic fever — a rare but life-threatening manifestation of dengue infection.In the commercial, a popular male soap opera star told parents returning for the funeral of their child that her death was caused by mosquitoes that bred on their property.A study done a decade later showed that people remembered the campaign more than any other — but they hated it. Rigau said they also reported changing the channel whenever it aired. Helen Branswell @HelenBranswell Senior Writer, Infectious Disease Helen covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development. “It’s part of our daily life,” explained Carmen Perez, a behavioral scientist at the Centers for Disease Control and Prevention’s dengue branch, headquartered in San Juan. “Getting dengue is like ‘Oh, dengue again.’”Because trying to prevent Puerto Ricans from getting infected would be as futile as trying to keep sand out of sandals at the beach, public health efforts are focusing on protecting a population facing a particular danger: pregnant women.advertisement Related: SAN JUAN — On this lush Caribbean island where window screens are scarce and mosquitoes rule, public health officials are preparing for a major battle against the Zika virus. But they are also gearing up to wage war on another foe: complacency.Based on the way related mosquito-spread viruses have swept through Puerto Rico in the past, health authorities predict Zika will hit this island hard, with as many as one in five residents expected to be infected at some point this year.But Puerto Ricans aren’t concerned about being bitten by mosquitoes. They view bouts of diseases like dengue fever and chikungunya — painful and unpleasant though they may be — as no more avoidable than the occasional flu. That, officials said, means helping to protect them from Zika, and persuading them of the importance of the effort, isn’t going to be easy.advertisement By Helen Branswell March 4, 2016 Reprints HealthIn Puerto Rico, no one fears mosquitoes. With Zika, that’s a problem An old information board on how to avoid the spread of the Aedes aegypti mosquitoes at the CDC Dengue Branch building in San Juan. Erika P. Rodriguez for STAT Tags global healthmosquitoesZika Viruslast_img read more

Phone use before bedtime is tied to poorer quality sleep

first_imgThinking back to the recent World Series, for instance, “it’s possible that if you are a Cubs fan or an Indians fan, and you’re looking at your phone, it really has nothing to do with the light [impacting your circadian systems],” Rea said.Likewise it’s also possible that poor sleep could lead to more screen time. The study just correlated the two and didn’t show causation. Finally, since the study used data from two different time periods, it wasn’t able to determine whether phone use on a particular day impacted the quality of sleep that night. Please enter a valid email address. Related: Privacy Policy What you need to know about the new study on cellphones and cancer By Ike Swetlitz Nov. 9, 2016 Reprints People who spend more time staring at their phones before bedtime get a worse night’s sleep, researchers found, in the first study that directly measures screen time using a mobile application.Why it matters:Previous studies have found an association between using devices with screens and poor sleep quality. However, scientists aren’t sure exactly why that is. Exposure to blue-colored light, such as that produced by electronic screens, is known to stimulate wakefulness. Electronic device use before bedtime might also simply stress us out. And some research has shown that there are associations between simply having electronic devices in the bedroom and worse sleep — possibly pointing toward some other confounding factor.The nitty-gritty:Dr. Gregory Marcus, cardiologist at the University of California, San Francisco, used data from the Health eHeart Study, which was set up to do research on cardiovascular disease. Participants in the study recorded many different things about themselves, including when they went to bed, how long they slept, and how well they slept, but didn’t know when reporting the data that it might be examined for a relationship with cellphone use.advertisement Leave this field empty if you’re human: What they’re saying:As the first sleep-related study to measure smartphone use with a mobile app, the study should be an example for other screen-time studies, said Lauren Hale, a board member of the National Sleep Foundation.“There’s more to be done,” Hale said. “This is only focusing on one tiny aspect of our intimate relationship with digital media.”The bottom line:Smartphones are but one aspect of a modern society filled with constant stimulation, and researchers aren’t surprised that they’re associated with lower quality sleep. Quick TakePhone use before bedtime is tied to poorer quality sleep APStock Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day. Then, Marcus and his team invited those same people to download a smartphone app to track when their phones’ screens were on. One hundred and thirty-six people used the app for at least a month and also had sleep quality data on file — and, among them, Marcus found that more screen time was associated with poorer quality sleep. Specifically, using a smartphone closer to bed was more strongly associated with poorer sleep quality than using a smartphone earlier in the day. The study was published Wednesday in PLOS ONE.But keep in mind:Mark Rea, director of the Lighting Research Center at Rensselaer Polytechnic Institute, who was not involved in this study, said that there isn’t enough data there to say why people who spent more time with smartphones had worse sleep.advertisement Tags cellphonescircadian rhythmsleeplast_img read more

Should you get screened for prostate cancer? We break down the latest advice

first_img Tags cancermen’s healthpatientsphysicians By Sharon Begley April 11, 2017 Reprints If 1,000 men get PSA screening (cost: roughly $40), 240 will be told their PSA level suggests cancer might be present. Next step: a biopsy, in which a needle, usually inserted through the rectum, samples several spots in the prostate gland.Of those 240 biopsies, 140 men will be told, oops, the PSA was misleading: You have no signs of cancer. These are called false positives.Of the other 100 men, in whom biopsy shows definite cancer, up to 50 have malignant cells that will turn out to be so slow-growing — “indolent” — that the cancer would never spread or harm them. These are called overdiagnoses.Unfortunately, it’s impossible to tell from looking at cancer cells if they’re wimps or killers, so 80 of the 100 men with prostate cancer choose surgery or radiation treatment, either right away or after first trying “active surveillance” (frequent PSA tests, exams, biopsies). At least 60 men suffer urinary incontinence and sexual impotence from the treatment.Of the 80 treated men, only three benefit. In the other 77, the cancer either wouldn’t have caused harm if left untreated or is so aggressive that treatment doesn’t help.Of the three men who benefited at all, 1.3 who would have been killed by prostate cancer without PSA screening will not be, over a period of 10 to 15 years.Bottom line: 1,000 men screened, one prostate-cancer death averted in that time. @sxbegle Translation: learn as much as you can, talk to your physician, then decide for yourself. Ben Stiller reveals prostate cancer diagnosis, says PSA test saved his life Hormone therapy for prostate cancer associated with greater risk of dementia What do other groups think?The American Cancer Society is also in the “talk to your doctor” camp.Because “research has not yet proven that the potential benefits of testing outweigh the harms of testing and treatment,” it says, men should discuss the pros and cons of PSA screening starting at age 50 (but 45 if you’re African-American or have a father or brother who had prostate cancer before age 65).Even the American Urological Association, which practically accused the task force of killing men with its “not recommended” conclusion of 2012, says routine PSA screening is not advised for men younger than 54 or older than 70. For those 55 to 69, it recommends “shared decision making” — talk to your doctor, understand the risks and benefits and the odds that you’ll be better off — and biannual rather than yearly screening for men who opt in. Penis shrinkage, a side effect of prostate cancer surgery, is temporary, study finds Newsletters Sign up for Morning Rounds Your daily dose of news in health and medicine. About the Author Reprints Related: Leave this field empty if you’re human: So if I opt for PSA screening I’m gambling that I’ll be the 1 in 1,000?Yes.Why did the task force back off its 2012 thumbs-down on PSA screening?By 2012, studies comparing men who undergo PSA testing to men who do not had found that the harms of testing (false positives, overdiagnosis, impotence, incontinence) outweigh the benefits. Specifically, the data available then indicated that just 0.8 of 1,000 men who undergo PSA screening would be spared a prostate-cancer death over the following 10 to 15 years, said Dr. Alex Krist, a task force member and associate professor of family medicine at Virginia Commonwealth University.By continuing to follow men in the studies, researchers now find that 1.3 prostate cancer deaths are prevented per 1,000 men screened. Just as important, more men are opting for active surveillance instead of treatment. That means the potential harms — impotence, incontinence — of screening are less than the last time the task force calculated all this, “making the balance of potential benefits and harms a little more positive,” Krist said.Dr. James Eastham, a prostate cancer surgeon at Memorial Sloan Kettering Cancer Center, welcomed that. “This is a reasonable step back from the previous ‘we don’t recommend routine PSA screening,’” he said. “But it’s true that everyone shouldn’t be tested, and that many men with an elevated PSA don’t have cancer at all or, if they do, that cancer doesn’t pose a risk to his life.” [email protected] Great. How do I do that?The task force created a useful graphic to help you. We hope you like numbers:advertisement Privacy Policy Senior Writer, Science and Discovery (1956-2021) Sharon covered science and discovery. Related: A panel of experts in preventive medicine released a draft proposal Tuesday on screening for prostate cancer. “Another one?” you may ask, remembering an earlier recommendation. Don’t worry; we’re here to help you avoid whiplash:What’s new?What was emphatic before is wishy-washy now. The last time the US Preventive Services Task Force weighed in on prostate cancer screening via blood tests, in 2012, it issued unambiguous advice to physicians: discourage men of all ages from getting tested for levels of prostate-specific antigen (PSA). That’s still the advice for men older than 70 or younger than 55.But for those aged 55 to 69, the task force, a panel of independent experts who advise the federal government, is punting: It recommends “informed, individualized decision making based on a man’s values and preferences.”advertisement Please enter a valid email address. Sharon Begley Every time there’s a medical controversy, experts seem to duck, telling me to ask my doctor — who has about 13 minutes for me.“Incorporating shared decision making [into a doctor’s visit] is difficult,” Krist acknowledged. “Physicians are busy, and this is a complicated topic.” He suggests that men learn what they can before a visit — and even print out a cost-benefit analysis. Then they ought to make an appointment to discuss PSA and nothing else, and take their time deciding.How can I tell the task force what I think?Until May 8, you can submit comments online. Eventually, the task force will finalize the recommendation. HealthShould you get screened for prostate cancer? We break down the latest advice Related: BRENDAN SMIALOWSKI/AFP/Getty Imageslast_img read more

Pharmalot, Pharmalittle: Amgen suffers big setback with osteoporosis drug

first_img STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Pharmalot, Pharmalittle: Amgen suffers big setback with osteoporosis drug Ed Silverman Alex Hogan/STAT Good morning, everyone, and welcome to another working week. We hope the weekend respite was refreshing and invigorating, because the usual routine of deadline, meetings, and whatnot has forcefully returned. You knew this would happen, yes? To cope, as you can guess, we are quaffing cups of stimulation. As always, you are invited to join us. Remember, no prescription is required. Meanwhile, here are some tidbits for you to enjoy. Hope you have a smashing day and do keep in touch …Amgen and UCB disclosed their experimental osteoporosis drug, which is awaiting US regulatory approval, yielded a higher rate of serious heart problems that were not seen in earlier studies. Although the drug met the primary and key secondary goals of a late-stage study, Amgen does not expect approval this year. Evercore ISI analyst Umer Raffat wrote this is “very surprising,” noting Wall Street expected $800 million in peak annual sales. Pharmalot Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED What’s included? By Ed Silverman May 22, 2017 Reprints [email protected] center_img Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Tags pharmaceuticalsSTAT+ About the Author Reprints GET STARTED Log In | Learn More What is it? @Pharmalot 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.last_img read more

Our bodies are full of bugs. This MIT engineer wants to manipulate them to treat disease

first_img [email protected] Tags antibioticsdrug developmentresearchSTAT+ In the Lab General Assignment Reporter Eric focuses on narrative features, exploring the startling ways that science and medicine affect people’s lives. About the Author Reprints Log In | Learn More @ericboodman What is it? 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. Dr. Timothy Lu, an associate professor of biological engineering and electrical engineering at MIT, is a cofounder of Synlogic and Eligo Bioscience. Courtesy Timothy Lucenter_img STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Our bodies are full of bugs. This MIT engineer wants to manipulate them to treat disease Our bodies are full of bugs. They’re everywhere, hanging out on our skin, reproducing in our gut, growing on the glistening surface of our eyes. These bacteria, it turns out, don’t just beget other bacteria. They also beget scientific paper after scientific paper, which, in turn, beget headline after headline.But for all our talk of microbiomes, we aren’t all that great at shaping them, says Dr. Timothy Lu, an associate professor of biological engineering and electrical engineering at the Massachusetts Institute of Technology. Eric Boodman By Eric Boodman Nov. 21, 2017 Reprints What’s included? Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED GET STARTEDlast_img read more

Pharmalittle: Sanofi wins bidding for Ablynx; Roche hemophilia drug can reduce costs

first_img GET STARTED Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED About the Author Reprints Log In | Learn More STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and fruitful, because the predictable routine of meetings, deadlines, and the like is now upon us. There is only one thing to do when confronted with such a situation — reach for a cup of stimulation. Our flavor today is macadamia nut, for those keeping track. Feel free to join us. Remember, no prescription is required. Meanwhile, here are some tidbits to get you started. Hope you have a smashing day and do keep in touch …Sanofi (SNY) agreed to pay $4.8 billion to buy Ablynx (ABLYF), outbidding Novo Nordisk (NVO) for a drug to treat a rare blood clotting disorder, The Wall Street Journal notes. This is the second deal this month for Sanofi, which is paying $11.6 billion for Bioverativ (BIVV) and its hemophilia treatments. Sanofi has been under pressure from investors after losing out on two attempted takeovers — Medivation and Actelion Pharmaceuticals — in 2016. Alex Hogan/STAT Pharmalittle: Sanofi wins bidding for Ablynx; Roche hemophilia drug can reduce costs [email protected] Pharmalot 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. Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. By Ed Silverman Jan. 29, 2018 Reprints Tags drug developmentfinancepharmaceuticalspharmalittlepolicySTAT+ What’s included? @Pharmalot What is it? Ed Silvermanlast_img read more

Do we keep waiting for the next pandemic or try to prevent it?

first_imgOne example of this is cholera: a highly neglected disease that is entirely preventable through access to clean water and good sanitation and hygiene. It has almost come to be expected in areas of extreme poverty, such as in Cox’s Bazar in Bangladesh, where nearly more than 900,000 Rohingya refugees have settled, or in war-torn countries like Yemen. In the Democratic Republic of the Congo, a woman washes her hands with water from a tank bearing a WHO sticker as prevention against Ebola. JUNIOR D. KANNAH/AFP/Getty Images ‘You’re holding your breath’: Scientists who toiled for years on an Ebola vaccine see the first one put to the test @GaviSeth EXPLORE: How Yemen’s cholera outbreak spread to a half-million people Related: By Seth Berkley June 14, 2018 Reprints With diseases like Ebola, where there is no cure and predicting outbreaks is difficult, vaccination is essential. And since the West African epidemic, which killed more than 11,000 people and infected nearly 29,000, we now have an investigational vaccine from Merck that a trial at the tail end of that outbreak showed to be safe and effective.With $1 million of initial operational support from Gavi, the Vaccine Alliance, which I lead, up to 300,000 available doses from Merck can be used by the World Health Organization and its partners to try to swiftly contain and end the DRC outbreak. For the people of Bikoro, in the DRC’s Equateur province, where there are already 55 suspected cases of Ebola and 28 deaths, this vaccine could be a lifesaver. Without such tools, we risk further spread, which could be devastating, particularly as we have now seen cases in the urban center of Mbandaka, the provincial capital of Equateur.While stockpiles are essential, they remain only part of the solution. As cities continue to grow, our best defense will be anticipating outbreaks before they occur. For some diseases, that means making childhood immunization and pre-emptive vaccination campaigns a priority. In other cases, it may mean greater investment in sanitation infrastructure, which can help prevent not just cholera but other water-borne diseases, like the diarrhea-causing rotavirus. And many poor countries are in desperate need of basic diagnostics and surveillance capabilities, enabling them to detect an outbreak as early as possible gives them an opportunity to quickly respond.All too often with infectious diseases, it is only when people start to die that necessary action is taken. To avoid this, the answer is simple: All countries must step up their long-term efforts to prevent and, wherever possible, eliminate infectious disease. If we keep waiting until outbreaks occur, we may soon find that our ability to respond, contain, and end them is gravely inadequate.Seth Berkley, M.D., is CEO of Gavi, the Vaccine Alliance. This is part of a growing global trend of urbanization that is expected to lead to two-thirds of the world’s population living in urban areas by 2050. Whether people are drawn from rural areas to cities by better economic prospects, or driven by conflict or climate-related events, such as flooding, desertification, or land degradation, the result is often the same — slums.Large numbers of often unvaccinated people living close to each other in squalid conditions, with limited access to primary health care facilities or clean water and sanitation, create a fertile breeding ground for infectious disease and the insects that spread them. One example is the recent outbreak of antibiotic-resistant typhoid spreading in the slums of Karachi, Pakistan. One case has already been exported to the United Kingdom.Disease tends to spread more easily and more rapidly among denser populations. And as populations grow, they can put a greater strain on already stretched resources, from sanitation to medical resources such as vaccines. Over the last few years, we have seen demand for emergency stockpiles of vaccines for diseases like cholera and yellow fever increase dramatically. While we can currently meet this demand, the growing number of mega-cities with populations of 10 million or more, and the increasing risk of urban epidemics that come with them, could deplete these stockpiles very quickly.center_img News of the latest Ebola outbreak in the Democratic Republic of the Congo is an urgent reminder that we need to change the way we fight disease, and we need to do so now.Over the last few decades, the number of disease outbreaks has more than tripled, culminating in three major epidemics in recent years — Ebola, yellow fever, and Zika. Despite this, governments often respond to outbreaks only once they occur, rather than investing in ways to stop them in the first place. If this continues, there will be a growing risk that we will not only undermine the great progress that has been made in fighting infectious disease, but we could even see a resurgence of highly preventable diseases that were previously in decline.Global trends are steadily altering the global health landscape, making it easier for disease to spread. Despite the scientific and medical advances of the last century, climate change, population growth, human migration, urbanization, vaccine hesitancy, and antimicrobial resistance could start to make future outbreaks increasingly difficult to contain.advertisement First OpinionDo we keep waiting for the next pandemic or try to prevent it? Related: About the Author Reprints While fragile states are particularly vulnerable to diseases like cholera, it can sometimes be a consequence of economic growth. Zambia, one of the fastest-growing economies in the world, has experienced a cholera outbreak every year for the last 35 years, mainly due to large areas of unplanned urbanization in parts of its capital, Lusaka.advertisement Seth Berkley Tags global healthinfectious diseasepublic healthVaccineslast_img read more

In a surprise, Hans Bishop takes over as CEO of Grail, the liquid biopsy startup

first_imgBiotech @matthewherper What is it? Hans Bishop is the new CEO of Grail. Juno Therapeutics What’s included? Grail, the San Francisco company that has raised $1.6 billion to develop a blood test to detect cancer, announced Thursday that it had appointed Hans Bishop, previously the CEO of Juno Therapeutics, as its new chief executive.Bishop, who led Juno until it was sold to Celgene for $9 billion in March 2018, will be the third chief executive Grail has had since it was founded in 2015. He will replace Jennifer Cook, a former Roche executive; Grail said Cook was leaving the CEO job for family health reasons. In a surprise, Hans Bishop takes over as CEO of Grail, the liquid biopsy startup Tags biotechnologycancer About the Author Reprints Log In | Learn More center_img 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. Unlock this article — plus daily coverage and analysis of the biotech sector — by subscribing to STAT+. First 30 days free. GET STARTED Matthew Herper Senior Writer, Medicine, Editorial Director of Events Matthew covers medical innovation — both its promise and its perils. [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. By Matthew Herper June 6, 2019 Reprintslast_img read more

Once I was warned not to be a ‘mommy doctor.’ Was I becoming a ‘mommy writer’?

first_img About the Author Reprints This toxic seed took root in my mind during medical school. After ranting about how he worked more than some of his female colleagues, the emergency medicine physician I was working with asked: “You’re not going to become one of those fake mommy doctors, are you?”I recognized how callous and disdainful he sounded, but I didn’t want to contradict my supervisor, nor did I want to fulfill this stereotype of a woman in medicine. I promised him, and myself, that I wouldn’t become a “mommy doctor.”advertisement My mother described her weekends on call — leaving home on a Friday morning and not returning home until Monday night. “It was the worst. … I would cry until I got to work.”Like me, she feared failure, what she labeled as “that sense of letting myself down.” But eventually she recognized that motherhood was an experience and opportunity that opened new doors. The moment she decided to transition to family medicine, a specialty that ultimately allowed her to thrive both personally and professionally, she felt relieved that she had time for both her patients and her family. Things happen in life for a reason, she counseled, it may be unclear in the moment, but eventually it all balances out. I don’t know what I’ll say when people ask me how I’m able to be a mother, a doctor, and a writer. As the writer Sarah Manguso explains, through motherhood I am able to “perceive the world more carefully and more lovingly than before because I am more aware of the effects of love and of time on an individual person. And I am more aware of the limits of love and of time.”I hope my newest, and perhaps most important role, will make me a better doctor and a better writer. Of this I am certain: In facing my struggle with failure, I’ve learned to lean into the wisdom and grace of the “mommies” around me.  Exclusive analysis of biopharma, health policy, and the life sciences. @JenniferAdaeze I did not know what I was promising. STAT+: Related: By Jennifer Adaeze Okwerekwu July 10, 2019 Reprints Determined to carry my own weight and keep my doctor-self intact, I took 24-hour call shifts the week my baby was due. It was hard, but passing this test of perseverance gave me a perverse sense of pride. But my writer-self lagged behind and I wobbled on one pillar without the strength of the other. The longer my column lay dormant, the more fragile my identity felt. My writing made me feel special and that I had something useful to contribute to the world. Who was I if not a physician-writer? I loved my child even before she was born and I imagined that motherhood would make my life more full. But, as my drive to create dwindled, I struggled to recognize myself. Was this — becoming a “mommy writer” — the sacrifice of motherhood? The exchange of one love for another? I wondered, what would happen to my ambition?After my baby was born, I sat down and talked to my mother, Dr. Adetutu Adetona, my first female role-model in medicine and the hardest-working woman I know. Her story was both surprising and familiar.When it came to balancing her training as an ear, nose, and throat surgeon with motherhood, she said “there was no doubt in my mind that it was easily doable.” But no sooner did she start the training did she begin to understand that her dreams of being a surgeon came at a cost. center_img “You make time for the things you love.” That’s what I have always said when asked how I am able to be a writer and a doctor-in-training. Over the past decade, I have stood firmly balanced on these twin pillars of my identity. That is, until motherhood changed everything.I thought having a baby would also be easy to balance, but as my body and mind made room for my daughter, I found less space to write. For me, pregnancy and its exhaustion made putting pen to paper impossible. I didn’t feel like myself and even worse, I felt like a failure. As a psychiatrist I tried to practice the same self-compassion I preach to my patients, but I couldn’t shake the nagging feeling of inadequacy. I really believed that pregnancy was not an acceptable excuse for any concessions in my professional life. advertisement Off the ChartsOnce I was warned not to be a ‘mommy doctor.’ Was I becoming a ‘mommy writer’? [email protected] Mike Reddy for STAT Jennifer Adaeze Okwerekwu We were inspired to become primary care physicians. Now we’re reconsidering a field in crisis Columnist, Off the Charts Jennifer Adaeze Okwerekwu is a psychiatrist and a columnist for STAT. Tags physicianslast_img read more