June 2021

first_img The research is getting underway at a time when the American Medical Association is advocating for a ban on prescription drug ads, the American public is infuriated over high drug prices, and pharmaceutical companies are increasingly advertising treatments for more serious conditions than had been seen on the airwaves before.The new study is part of an entire field of study by the FDA. In 2012, the agency published a report that found simple information in drug ads (a comparison to a placebo, for example) presented in certain ways helped people better understand how well the drug worked.advertisement APStock WASHINGTON — The Food and Drug Administration wants to figure out just how well older Americans are able to comprehend the prescription drug ads they see on TV.In an upcoming study, described in a notice posted publicly late last week, the agency will test whether Americans 60 and older understand some of the more complex information presented in the commercials they see between network news and NFL football games. They want to test whether people understand more complex ads as well as they did simpler ads — or if it is too much information for people to process.Americans 60 and older will participate in the studies, the agency said, because they are more likely to be interested in the drug being studied and therefore more motivated to pay attention. The FDA noted that older people use more prescription drugs and watch more television than younger people.advertisement Related: Lawmaker seeks to end tax breaks for consumer drug ads Related: Drug makers now spend $5 billion a year on advertising. Here’s what that buys. center_img PoliticsThe FDA wants to know how well older people understand TV drug ads Tags drug adsFDAgeriatricspolicy By Dylan Scott March 21, 2016 Reprints Julie Donohue, a University of Pittsburgh professor who has researched direct-to-consumer drug advertising, characterized the FDA’s new study as an attempt to determine “how much can we throw at people and expect them to retain?”Participants will be shown TV ads twice for a fictional medication for cataracts. They will then take a survey gauging how well they understood the information in the ad, how well they retained the information, and how they ultimately perceived the drug’s risks and benefits.The ads will vary. Some will describe side effects more simply, for example, occurring in “10 percent or less” of patients; others will be much more specific — say, 6 percent to 10 percent. Some ads will give only a single outcome for taking the drug (52 percent improved their vision); others will offer an additional outcome (52 percent improved their vision and people were able to see on average 85 out of 100 letters in an eye chart test).In a related study, the agency will also examine whether different visuals — one that accurately represents the drug’s benefits, another that overstates them, or no image at all — affect how people perceive the information in the ads. The FDA has also undertaken a separate project researching whether cartoons in drug ads distort how viewers perceive the drug’s risks and benefits. The question of what information in drug ads is useful to consumers dates back at least to a 2004 study published in Health Affairs by Drs. Steven Woloshin and Lisa Schwartz of Dartmouth University. They found that a “benefit box” helped lower people’s perception of how well a drug worked — people tend to be overly optimistic about how well advertised medications work without information being put in context, experts say.A 2011 study published in the Journal of Health Communication focused specifically on the elderly and found that their ability to understand drug ads was dependent on how well they were able to understand other kinds of medical information. If they were less literate in medical information, they were less able to understand the ads — a finding that “alerts us to the inadequate informational values of (direct-to-consumer) ads for consumers who truly need such information in order to be more educated and empowered,” the authors wrote.Meredith Rosenthal, a Harvard University professor who has studied drug advertising, said she wasn’t sure how much progress can be made in improving comprehension of TV drug ads. Some research suggests that drug ads mostly serve as a motivator to get people to go see their doctor, and so it’s not clear how much their content actually matters.“I’m not sure how critical it is that consumers understand those risks,” she said. “I think what’s critical is that physicians understand that.”She added, though, that she saw the FDA study as “a completely legitimate question to ask and potentially important pursuit.”And even if the net effect of most drug ads is driving people to the doctor’s office, Donohue thought more detailed information in those ads could still change people’s behavior.“I think this information could have an effect on whether patients actually ask for medications,” she said. “If it changes the perception of efficacy and safety … then it will change the behavior.”last_img read more

first_imgResearchers from the Harvard T.H. Chan School of Public Health conducted the poll earlier this month in cooperation with the National Public Health Information Coalition, an organization of health communications professionals. (STAT regularly partners with the Harvard school on polls but was not involved with this particular survey.)Overall, the poll captured that sizable portions of the public are not sure or are wrong about how Zika spreads and manifests in people. Forty percent did not know the virus can be sexually transmitted, and 31 percent thought — incorrectly — that the virus can migrate through coughing and sneezing.Almost 4 in 10 people believe a woman who contracts the virus may be at higher risk for having a baby with birth defects in the future. Researchers are still studying how long the virus can stay harbored in the body, but so far, the evidence indicates that Zika clears the blood in a week or so, and after that a woman will not face an elevated possibility of defects in subsequent pregnancies.The poll surveyed 1,275 adults by phone, including 105 people who live in homes where someone is pregnant or thinking about getting pregnant in the next year. The overall results are accurate to within 3.23 percentage points, 19 times out of 20. @DrewQJoseph About the Author Reprints By Andrew Joseph March 29, 2016 Reprints Related: A majority of Americans would support spraying against mosquitoes if Zika appeared in their area. Orlando Sierra/AFP/Getty Images Two-thirds of the public take regular precautions in the summer to escape mosquitoes. For specific countermeasures, 56 percent said they wear repellant, and 55 percent remove standing water around their homes, which deprives mosquitoes of breeding grounds near people.For mosquito control at a larger scale, 81 percent of responders said they would approve of ground spraying in their cities or towns if Zika cases appeared, and 66 percent said they would support spraying from the air under those circumstances.advertisement Andrew Josephcenter_img Health1 in 3 Americans think you can catch Zika from a sneeze Everything you need to know about Zika virus General Assignment Reporter Andrew covers a range of topics, from addiction to public health to genetics. The majority of Americans know the basic facts about Zika virus, but misperceptions abound about how the virus spreads and causes disease.That’s the take-home message of a national poll released Tuesday, which found that 87 percent of the US public knows that Zika is transmitted by mosquitoes, but a good-sized minority is unaware or misinformed about how else the virus is contracted.The Zika virus has been spreading rapidly in the Americas, but so far there has been no mosquito-borne transmission in the continental United States. Experts think that could change come summer when mosquitoes become more active, and the poll found some positives signs.advertisement [email protected] Tags microcephalymosquitoesZika Viruslast_img read more

first_img Please enter a valid email address. Leave this field empty if you’re human: Yet Weng and Torrens-Spence have succeeded at coaxing yeast into manufacturing the Tibetan golden root’s medicinal chemical in a beaker, providing a new, inexpensive way to collect it. Their paper should be coming out in the next few months — and they’re filing a patent to go with it.It’s hard to say whether a Food and Drug Administration-approved drug will emerge from those beakers. Or from the flower across the greenhouse that looks like the frilly hem of a flamenco dress. Or from the surfing postdoc’s seaweed.But walking among his beakers clouded with bacteria and his vials of pollen, Weng doesn’t look nervous. As Torrens-Spence puts it, “We have the luxury of being opportunistic. There is potential absolutely everywhere.” Privacy Policy Kendall Squared brings you dispatches from the world’s epicenter for biotechnology and drug discovery.The sludge under the lab bench looks like leaf litter soup. Vials of brown, ochre, and reddish pollen extracts clutter the surface above. Beside them, a foil-covered beaker contains an herbal broth. It’s cloudy, like a bit of raw egg white left out overnight.To biologist Jing-Ke Weng, that mess is a treasure — a rich source of potential medicines to treat cancer, perhaps, or insomnia, or blood disorders.Many drug discovery experts would be skeptical. They’d point out that the biggest pharma companies in the world have spent decades, and millions, trying to make new drugs from plants. They’d tell him it’s just too hard.advertisement Newsletters Sign up for Morning Rounds Your daily dose of news in health and medicine. The idea is not new. Some of our best-selling commercial drugs come from plants: aspirin from willow bark, the tumor-slowing Taxol from the Pacific yew tree, the leukemia medication vincristine from a pinkish jungle flower called the rosy periwinkle. And last year, Chinese chemist Tu Youyou shared the Nobel Prize in Physiology or Medicine for her research on artemisinin, a malaria drug extracted from a delicate bush called sweet wormwood.advertisement Michael Torrens-Spence, researcher in Weng’s lab Weng’s mother wasn’t a trained traditional Chinese herbalist, but she knew enough to treat the everyday colds, and scrapes, and stomachaches of childhood. His father was a geologist. He would take Weng out on field trips, pointing out different kinds of rocks, talking about continental drift.But it was the plants and insects that Weng really wanted to play with.He moved away from them as an undergraduate, doing neuroscience research. But he didn’t like having to kill mice for work. And so, for his PhD at Purdue, he began to work on the chemistry of wood.Weng was investigating a compound called lignin. When it appeared millions of years ago, it hardened cell walls, making plants able to grow taller, prevent rot — and, eventually, allowing trees to produce enough oxygen for insects to evolve flight.To make chemicals like lignin, the plant has to develop a kind of inner assembly line.Imagine a series of autoworkers, each one responsible for tightening screws or punching holes over and over again. In the plant, enzymes play that role, taking the basic molecular chassis and adding an oxygen here, a carbon there, until the simple molecule has been turned into a sophisticated piece of machinery.Weng was able not only to identify the steps in that molecular assembly line; he was also able to pinpoint the genes that had allowed them to evolve in that particular plant family to begin with.“He was the most creative student I have ever had and probably will ever have,” said Clint Chapple, his PhD supervisor at Purdue. “Most PhD students graduate with one, two, three scientific papers that they’ve led. Jing-Ke published 13 papers out of his PhD. Normally, you get tenure for publishing that many papers.”Vials of pollen extract could hold the secrets to future medicines. Pat Greenhouse/The Boston Globe Looking to Amazon for guidanceWeng may have been a superstar of a PhD student, but the job offer from the Whitehead Institute surprised him.The Whitehead is a center for biomedical research, full of cancer biologists. Weng had spent years unraveling the molecular pathways that allowed plants to stand up.But he was unfazed. He knew how to break apart assembly lines of enzymes — and those tiny factories produced an almost infinite catalogue of strange chemicals, many of them medicinal.He began to seek them out.From a lecturer at a natural history museum, he heard that Melanesian tribes used the calming Kava Kava root for rituals. Soon after, he was unpacking live plants from a nursery in Hawaii. At a high school science fair, Weng’s father saw an experiment suggesting that peanut skins could help patients with low platelet counts. He mentioned it to his son, and Weng bought 11 pounds of peanut skins from China. They’re soaking in ethanol under a lab bench.One of his postdocs — a surfer — pulled a wrack of red algae from a tide pool in California, having read that it harbored cancer-fighting compounds. Now they’re preparing to sequence it in Weng’s lab.Sometimes Weng uses Amazon.com, where there is a lively trade in herbal supplements, to gauge the potency of a plant, by looking at the comments from people who have ordered extracts.“People actually are [reporting] the type of response they’ve observed from their own body. It’s free information,” he explained. If enough people report a reaction, he figures the plant is worth investigating: “It’s reassuring that it’s not time wasted.”In January, one of Weng’s postdocs ordered an extract of Kava Kava on Amazon and made a home brew. It tasted, he said, like spicy mud. At the suggested dose, the drink had no effect. But at a higher concentration? “Instant happiness.” Why Nestlé — yes, that Nestlé — is acting a lot like a drug company Related: Weng, though, isn’t worried. At 34, he’s already helped map the molecular factories that produce some of the most important plant chemicals around. And now that he’s working at the Whitehead Institute for Biomedical Research, he’s determined to harness peanut skins, and twisted roots, and an herb known as horny goat weed — and the strange blooms in a seventh-floor greenhouse — to treat human disease. Related: @ericboodman Eric Boodman “We have the luxury of being opportunistic. There is potential absolutely everywhere.” About the Author Reprints But this type of botanical sleuthing is an anomaly in the biotech hotbed of Kendall Square.Most large pharmaceutical companies phased out their screening of natural products in the 1980s. It was expensive, and eureka moments often turned sour: The researchers kept rediscovering molecules that had already been identified.Academic labs and small startups have taken over some of that research — but they’ve focused mostly on bacteria and fungi, because in those micro-organisms, the genes that code for medicinal compounds tend to stick together.Not so with plants, said Gregory Verdine, a chemist at Harvard and founder of the natural products company Warp Drive Bio. “If you go into plants, you add another layer of complexity to what’s already incredibly complex,” he said.Inspiration in ‘fishy-tasting grass’Most scientists are loath to use the word “magical”— but that is Weng’s go-to adjective when describing his plants.The conviction began when he was a kid in Hangzhou, China. If he got sick, his mother would walk out of their first-floor apartment to collect a potful of what he translates as “fishy-tasting grass.” In those days, it grew everywhere, like a weed.His mother would bring it to a boil on the stove for 20 minutes, and then scoop out the soggy blades, serving him the blackish, smelly liquid that remained.“It doesn’t look good and it doesn’t taste good, but I like it, because it really helps when you feel bad,” he said. Jing-Ke Weng seeks medicinal compounds in the plants he grows at the Whitehead Institute. Pat Greenhouse/The Boston Globe When he gets a plant, the first thing Weng does is to destroy it. He separates leaf from stem from root, even plucking off the minute hairs. Then each part is mashed up. The genetic material is extracted and sequenced, while in another machine, the plant’s molecules are bombarded with electrons so that the chemical compounds can be identified.With those two sets of data, Weng tries to match the potent chemicals he’s interested in to specific genes. If he identifies the necessary genes, he can transplant them into E. coli or yeast, which will then serve as a living farm, churning out medicinal compounds.Red peanut skins soak in ethanol extract. Pat Greenhouse/The Boston GlobeA greenhouse full of potential miraclesA trip through Weng’s greenhouse shows why that microscopic mass production is so useful. Michael Torrens-Spence, a postdoc, stops beside a tiny reddish green plant called Tibetan golden root. It grows in rocky crags one mile above sea level, and it’s become so prized in traditional Chinese medicine that illegal harvesting has nearly wiped it out — making the compound “absurdly expensive,” Torrens-Spence says.A single milligram of extract powder — a quarter the weight of a grain of sand — can cost $200.To make things worse, if you grow the plant at lower altitudes, it stops producing the beneficial compound. Other specialized plant chemicals are similarly hard to get in quantities large enough even for basic research, not to mention a clinical trial. Could bugs in the gut offer clues for reducing the severity of stroke? By Eric Boodman April 7, 2016 Reprints General Assignment Reporter Eric focuses on narrative features, exploring the startling ways that science and medicine affect people’s lives. [email protected] In the LabIn high-tech hub, this scientist hunts for cures in the greenhouse Tags dietary supplementsdrug discoverypharmaceutical industrylast_img read more

first_img He indicated that still more lawsuits against state Medicaid programs are planned, but would not discuss specifics.We should note that the Obama administration last fall wrote state Medicaid programs that they may be violating federal law by restricting access to hepatitis C medicines. Placing restrictions may be “contrary to the statutory requirements” of a federal law that requires state Medicaid programs to pay for all medically necessary treatments, Center for Medicare & Medicaid Services officials wrote in their notice to the state programs.A spokeswoman for the Washington State Health Care Authority said the court opinion is being reviewed.The opinion is only the latest instance in which a public or private insurer has been forced to reconsider its coverage policies toward hepatitis C medicines, which helped trigger a wave of controversy over the cost of prescription drugs.Last month, seven commercial insurers reached an agreement with the New York attorney general to remove barriers to coverage of pricey hepatitis C medicines. The health plans had to eliminate restrictions that require their members to have an advanced stage of the disease, such as liver scarring, before treatment would be considered medically necessary. And various commercial insurers in Washington state and California recently eased coverage restrictions in response to lawsuits filed by consumers.Meanwhile, lawsuits are pending against the Indiana Family and Social Services Administration and the Massachusetts prison system. And the Massachusetts Attorney General has threatened to file a lawsuit against Gilead if it did not lower prices. That standoff has not yet been resolved. By Ed Silverman May 27, 2016 Reprints Related: PharmalotWashington state told to lift restrictions on hepatitis C medicines Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Ed Silverman Health plans reach deal with NY to cover hepatitis C drugs About the Author Reprints @Pharmalot Eric Risberg/AP Please enter a valid email address. “This is the first time a federal court has declared that widespread restrictions across a state Medicaid program is illegal for hepatitis C medicines,” said Kevin Costello, litigation director at the Center for Health Law and Policy Innovation at Harvard Law School. “It’s also important because this can be used to persuade other state officials to lift restrictions.” Newsletters Sign up for Pharmalot Your daily update on the drug industry. The Washington state Medicaid program has been ordered to lift restrictions on coverage of pricey hepatitis C treatments, according to a preliminary injunction issued Friday by a federal judge in Seattle.The ruling came in response to a lawsuit filed by state residents who claim the drugs are “medically necessary,” and that the decision by the Washington State Health Care Authority to provide coverage to only the sickest patients had caused them harm.In a strongly worded, 12-page opinion, United States District Court Judge John Coughenour agreed with their argument. He wrote that the facts “clearly favor” their contention that state policy violates federal law. In his view, the evidence “establishes that there is a consensus among medical experts and providers that the life-saving [drugs] are medically necessary” for all hepatitis C patients.advertisement Tags drug pricesGilead Scienceshepatitis Cpolicy Privacy Policy [email protected] The treatments boast very high cure rates but also are very costly, ranging in price from $54,600 to $94,500, depending upon doses and regimen, although this is before any rebates or discounts are applied. The hepatitis C treatments include Sovaldi and Harvoni, which are sold by Gilead Sciences, as well as medicines sold by Merck and AbbVie.One attorney who represents the state residents hailed the opinion.advertisement Leave this field empty if you’re human: last_img read more

first_img Safety issues at compounding pharmacy underscore oversight problems Ed Silverman [email protected] Tags compounding pharmacyFDAgeneric drugspolicy Robert Cianflone/Getty Images Related: Please enter a valid email address. Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day. About the Author Reprints In its latest to bid to set parameters around compounding, the US Food and Drug Administration last week issued a pair of draft guidelines to clarify when compounding pharmacies are permitted to make versions of commercially available medicines.Although federal law currently states that a compounder generally shouldn’t make copies of drugs that are approved for sale, the agency is getting more specific and wants to ensure that a true clinical need exists before a compounded version of an approved medicine drug is made for a patient.“The FDA is making a policy statement that you can’t just compound a copy and then market it,” said Elizabeth Jungman, director of public health at Pew Charitable Trusts, a nonprofit that studies health care issues. “There has to be a patient need. And it’s important from a safety perspective.”advertisement PharmalotFDA narrowly defines the ability of compounders to make approved medicines @Pharmalot By Ed Silverman July 11, 2016 Reprints A key issue has been the extent to which compounders can make medicines for patients in ways that may cross the line into more conventional drug manufacturing. The new law attempts to create boundaries, although the latest guidelines are designed to refine the FDA interpretation.For instance, the guidelines would permit compounders to make versions of brand-name drugs when a shortage exists or the brand-name medicine has been discontinued. Another example meeting the threshold of patient need might be a required change in formulation, such as different dosage strengths.But safety is not the only issue in play here. For instance, pointing to a lower price — in other words, a compounded version would be cheaper than a brand-name drug — is not justification for compounding an FDA-approved medicine.Brand-name drug makers would be less likely to invest in innovative medicines if a compounder — especially compounders that make large quantities of a medicine — is otherwise allowed to make and sell versions of treatments approved by the FDA, Jungman explained. Leave this field empty if you’re human: Similarly, generic drug makers may avoid seeking approval of copycat medicines if compounders can make copies of approved drugs, according to Robert Pollock, a former acting deputy director of the FDA Office of Generic Drugs, who now works at Lachman Consultants and advises drug makers.Of course, these are only draft guidelines — guidances in regulatory parlance — and are not set in stone. Manufacturers and others have an opportunity to comment. To date, the compounding industry has bristled at some restrictions contained in the new law.A spokeswoman for the International Academy of Compounding Pharmacists, an industry trade group, told us the guidelines are still being reviewed and that there is no comment at this time. The episode cast a harsh spotlight on compounders, as well as FDA and state oversight. In response, a federal law called the Drug Quality and Security Act was passed to beef up FDA authority to inspect facilities and enforce regulations.advertisement Indeed, there are ongoing safety concerns surrounding compounding pharmacies ever since a scandal erupted four years ago. That’s when injectable steroids made by a compounder in the Boston area were linked to 64 deaths and more than 750 cases of fungal meningitis around the country. Privacy Policy Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry.last_img read more

first_img General Assignment Reporter Liz focuses on cancer, biomedical engineering, and how patients feel the effects of Covid-19. APstock What is it? 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. [email protected] About the Author Reprints GET STARTED What’s included? Elizabeth Cooneycenter_img And the CRISPR science prizes go to… By Elizabeth Cooney Feb. 16, 2017 Reprints Tags geneticslegal In case you haven’t heard enough about Wednesday’s CRISPR patent ruling, we decided to tally up the winners in another court: the world of scientific prizes.Turns out, it’s not so easy to discern who’s ahead in prizes awarded for science related to CRISPR. But dollars and shares are two ways to get a sense. Some awards are announced with prize money amounts; some aren’t. Unlock this article — plus daily coverage and analysis of the biotech sector — by subscribing to STAT+. First 30 days free. GET STARTED Biotech @cooney_liz 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

first_imgCorrection: An earlier version of this story incorrectly attributed findings of fact to the Texas Medical Board. The findings of fact were issued by the State Office of Administrative Hearings, and were incorporated into the board staff’s proposed decision, along with the board staff’s proposed sanctions. In the board’s filings last summer, it accused Burzynski of unethical and unprofessional conduct regarding clinical trials of gravely ill patients. Those charges included improper care, deceptive advertising, and the use of unlicensed staff, among others.In the findings of fact issued Wednesday, the board’s staff quoted findings of fact issued by the Texas State Office of Administrative Hearings, which found insufficient evidence of deceptive advertising. However, it found, among other violations, that Burzynski in at least one case failed to follow the treatment protocol to which a patient initially consented, and that one of Burzynski’s clinicians misrepresented herself as being authorized to practice medicine.Elsewhere in the findings of fact, the Office of Administrative Hearings found that there was insufficient evidence to suggest patients suffered harm as a result of the violations.“Respondent’s continued practice in treating advanced cancer patients is a present value to the cancer community,” it read. “Respondent’s treatments have saved the lives of cancer patients, both adults and children, who were not expected to live.”In addition to the recommended fines, the board’s staff proposed ordering Burzynski to submit all patient-consent forms to the Board’s medical director for review, and complete a course in ethics. A long-running battle between the Texas Medical Board and controversial Houston doctor Stanislaw Burzynski could be coming to a head.The board’s staff said this week that it had proposed $380,000 in fines and a stiff set of sanctions for Burzynski’s failure to adhere to proper medical procedures in treating cancer patients. The decision is preliminary, and will be submitted and formally reviewed on March 3.The recommendations formally called for the revocation of Burzynski’s license, but the board’s staff then recommended suspending that sanction, pending a probationary period of at least four years, during which the physician’s work would undergo strict monitoring.advertisement By Bob Tedeschi Feb. 16, 2017 Reprints Dr. Stanislaw Burzynski, center, seen here in 1997, during a news conference and surrounded by supporters. David J. Phillip/AP To help cancer patients, lawmakers pushed access to a controversial doctor center_img Burzynski declined comment, but his lawyer, Melanie Rubinsky, said the physician would submit his own proposed ruling in advance of the March 3 board meeting. “The proposed order is not final until the full board signs off on it,” she said. “It’s not a done deal.”Under Texas law, even if the board adopts the staff recommendations, Rubinsky said Burzynski could pursue a court appeal.advertisement HealthTexas board recommends sanctions against controversial cancer doctor Related: Tags cancerphysicianslast_img read more

first_img NewslettersSign up for The Readout Your daily guide to what’s happening in biotech. David Silverman/Getty Images People grumble a lot about the shortcomings of the flu vaccine, which some years offers less protection than expected. (Warning: This year may be one of them.) What they may not know is that the source of at least some of the problems is a common item found in all grocery stores and many fridges.The egg.The overwhelming majority of flu vaccines are made from viruses grown in eggs. This production process is inexpensive and time-tested; flu vaccines have been made this way as long as flu vaccines have been made.advertisement Related: But the process is not ideal — and it leads to issues that can undermine the vaccine’s effectiveness. Increasingly, experts are questioning whether the pros of egg production are worth putting up with the cons.“We need to do a lot to improve existing vaccines. And getting away from eggs would be very valuable,” said Dr. Kanta Subbarao, director of the World Health Organization’s influenza collaborating center in Australia.advertisement Related: Privacy Policy Helen Branswell Dr. Daniel Jernigan, CDC By Helen Branswell Nov. 7, 2017 Reprints Researchers in the U.S., Canada, and parts of Europe conduct studies every year that estimate how effective flu vaccine was at preventing illness. But those studies are not enormous and most of the people in them would be getting flu vaccine produced in eggs, so teasing out an answer from that research may not be possible.Manufacturers themselves could study the question, and in a very crowded flu vaccine market may actually have motivation to do so. The CDC’s Jernigan noted that a few years back Sanofi Pasteur, the largest supplier of flu vaccine, funded a trial that compared a high-dose formulation it wanted to sell to seniors against its regular vaccine. The high-dose vaccine was found to be more effective, and the company is allowed to target individuals 65 and older, the demographic most likely to get flu shots.Studies that show convincingly that flu vaccines produced in cell culture or using other non-egg methods are better could lead the expert panel that counsels the CDC on vaccines, the Advisory Committee on Immunization Practices, to preferentially recommend those vaccines over vaccines produced in eggs.“I think that kind of pressure — if there are preferential recommendations related to that — will drive change in industry,” said Dr. Danuta Skowronski, an influenza expert at the British Columbia Center for Disease Control and lead author of a study that showed an egg-mutation problem in the 2012-2013 flu season.Others aren’t so sure the industry would be willing to make a major production shift, which would require manufacturers to conduct expensive trials, apply for new regulatory licenses, and build and certify new production facilities. How does the flu vaccine work?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/2017/11/07/flu-vaccine-egg-production/?jwsource=clCopied EmbedCopiedLive00:0000:4900:49  The vaccine triggers the immune system to create antibodies, preparing the body for viral battle. Alex Hogan/STAT “It’s a pretty big manufacturing lift. Or at least regulatory lift,” Jernigan said.The other hurdle is the fact that many in industry, government, and public health have their eyes on a bigger prize. Rather than a small change that might offer modest improvements to the performance of flu vaccines, they’re looking to a radical shift — a flu vaccine that offers long-term protection against most or all known flu viruses. It’s the Holy Grail of flu, the so-called universal vaccine.“In some ways, the whole discussion now about universal or game-changing vaccine has somewhat shifted the landscape. Because now people are going to say, ‘Wait a minute. Am I going to invest in an intermediate stage of vaccine production … and do this kind of fix on the current vaccine as an intermediate stage or interim stage?’” said Michael Osterholm, director of the Center for Infectious Diseases Research and Policy at the University of Minnesota.“This is where you’re talking about the business of vaccines as much as you are the science. The business of the vaccine has been in part why we haven’t seen the science further along. Everybody felt like they had a nice business model going with what they had.” Flu experts see potential for a nasty winter season Leave this field empty if you’re human: Producing too much of the nation’s ​flu vaccine supply in a single medium is literally as dangerous as putting all your eggs in one basket — especially given that some of the flu viruses that threaten to cause pandemics, such as H5N1 and H7N9, infect chickens, either killing them or reducing egg production.“When I look at a need to produce 600 million doses of influenza vaccine in a very short timeline of a pandemic, it’s going to be really important that we have all horses in the race. So eggs and cells and recombinant,” said BARDA Director Rick Bright.“Some [flu viruses] might grow well in eggs and some well in cells, and some better in recombinant systems,” he said. “So that’s been part of our strategy to make more capacity available domestically and also to diversify this for the various unpredictable attributes of influenza.”There are a few key hurdles for those interested in seeing more seasonal production move out of eggs. The first is that there isn’t much evidence yet that the vaccines produced in other mediums perform better than those made in eggs. Experts believe the FluBlok and Flucelvax may be more effective against H3N2 viruses this winter than the egg-based vaccines, but companies won’t be motivated to make what would be a very expensive production shift on belief alone.In fact, some companies that had been working on cell culture flu vaccines abandoned the work. “There wasn’t convincing evidence that it was better so why would anyone spend extra money to buy that?” noted Dr. John Treanor, a flu vaccine expert at the University of Rochester.“The business case was tough, and I think a lot of these enterprises did not make it partially because of that.”To be clear, it’s not that these vaccines have been shown to be less effective or no more effective than vaccines produced in eggs. It’s that in the main, proof that they are better is sparse to date. “If you were to start now with a new vaccine for flu, would it be grown in eggs? No.” Please enter a valid email address. To produce flu vaccine, most manufacturers must grow lots of flu viruses, which are later killed or weakened before they are put into the vaccine. In all but a few cases, those viruses are grown in hens’ eggs.But flu viruses must mutate — adapt — to grow inside eggs. Sometimes those mutations aren’t huge or aren’t on important spots on the virus and they don’t undermine the effectiveness of the vaccine. But when they are, the impact can be substantial. It’s as if the antibodies the vaccine generates are looking for Superman — but they encounter Clark Kent. The glasses, the suit, the tie confuse them; the antibodies don’t see Superman and the mild-mannered newsman as the same person and they don’t respond.Researchers have known for a while that this can happen. In a study released just Monday, scientists said that the disappointing performance of the vaccine last year was the result of a mutation that developed when the viruses for the vaccine were grown in eggs. The upshot: The antibodies generated by the H3N2 vaccine didn’t adequately target the viruses that were making people sick. Will this be a miserable flu season?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/2017/11/07/flu-vaccine-egg-production/?jwsource=clCopied EmbedCopiedLive00:0001:5401:54  STAT reporter Helen Branswell explains why it’s so difficult to predict the severity of the upcoming flu season. Alex Hogan/STAT The H3N2 component in this year’s flu vaccine is identical to the one in last winter’s, so the vaccine could fail to provide strong protection again if H3N2 flu viruses are in high circulation this winter.“To make a prediction about this flu season, it does appear if H3s do circulate, there will be this problem of this egg mutation,” said Scott Hensley, an associate microbiology professor at the University of Pennsylvania and senior author of the study, which was published in the Proceedings of the National Academy of Sciences.Moving out of egg-based production would improve the performance of the vaccine, many experts believe. About the Author Reprints Officially, the Centers for Disease Control and Prevention doesn’t have a preference for how flu vaccine is made — as long as the resulting product is safe and effective. But if you ask Dr. Daniel Jernigan, director of the CDC’s influenza division, if eggs are the future of flu vaccines, his answer is telling.“If you were to start now with a new vaccine for flu, would it be grown in eggs? No,” Jernigan said.The U.S. government office charged with preparing the country to deal with public health emergencies like flu pandemics has recognized the limitations of egg-based flu vaccine production for a while. For more than a decade BARDA — the Biomedical Advanced Research and Development Authority — has been working with manufacturers to encourage them to move some portion of production out of eggs.Its funding helped foster development of the two flu vaccines on the market that aren’t made in eggs — FluBlok, a recombinant vaccine developed by Protein Sciences (recently acquired by Sanofi Pasteur) and Flucelvax, produced in the U.S. by the Australian company Seqirus.The former is made of influenza hemagglutinin proteins — the main target of flu vaccines — that are generated by viruses that infect insect cells, while the latter is made of flu viruses grown in dog kidney cell lines.(Any time flu viruses have to adapt to grow in the cells of a new host — as in the case of the dog kidney cells — there can be mutations. But the egg-induced mutations seem more problematic. “I think historically just what we know about putting flu viruses in cells versus putting them in eggs is that generally the stability of the sequence is greater in mammalian cells,” said Jacqueline Katz, deputy director of CDC’s influenza division.) In the LabHow the incredible, edible egg may actually be hampering your flu vaccine Senior Writer, Infectious Disease Helen covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development. New flu findings may threaten prospects for universal vaccine @HelenBranswell Tags pharmaceuticalsVaccineslast_img read more

first_img By Ed Silverman March 16, 2018 Reprints Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Pharmalot What is it? Are consumers overpaying at the pharmacy counter? 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. Americans may be overpaying for their prescription medicines nearly one-quarter of the time, although the average amount was relatively modest — less than $8. And there were more overpayments involving generic drugs than brand-name medicines, according to a new analysis.Of about 9.5 million prescription insurance claims filed from January to June 2013, 2.2 million involved overpayments, and these totaled $135 million, or $10.51 per person, according to the analysis that was published in the Journal of the American Medical Association. And about 17 percent of the claims resulted in an overpayment exceeding $10. Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Ed Silvermancenter_img Log In | Learn More [email protected] 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. What’s included? About the Author Reprints APStock @Pharmalot Tags drug pricingpharmaceuticalsSTAT+last_img read more

first_img What is it? @eemershon What’s included? By Erin Mershon April 23, 2018 Reprints With a new slate of appointees, Trump’s FTC expected to take tough stand on drug industry About the Author 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. [email protected] Politics Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTEDcenter_img Log In | Learn More GET STARTED WASHINGTON — They are little-known lawyers and professionals — with almost no experience in health care. And yet they are poised to play an outsized role in the federal effort to bring down high prescription drug prices.The five men and women are in line to take charge of the Federal Trade Commission — a role that will let them decide whether to investigate companies over potentially anti-competitive tactics, whether to block mergers or acquisitions, and whether to demand more information about secretive business practices. Tags pharmaceuticalspolicySTAT+ Erin Mershon Senior News Editor 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. Adobelast_img read more