Why drug makers share their prized compound libraries with competitors

first_img Pharmaceutical companies amass huge libraries of chemical compounds they can test to see if one just might be capable of being developed into a new drug. But what if, even with millions of compounds, you’re missing some that could lead to your next blockbuster treatment?That was the idea behind Friday’s announcement that AstraZeneca and Sanofi will swap 210,000 compounds from their libraries, giving each company new compounds to screen. (It’s worth noting, as STAT Pharmalot Ed Silverman columnist points out, “the move comes as both companies struggle to replenish their product portfolios and appease restive shareholders.”)Companies measure the potential of the compounds through a process called high-throughput screening, in which the compounds are tested on different cells or molecules to see if they are a “hit” for a certain disease target. If there is a hit, scientists work to refine the compound and then start testing it in animal models to explore if it could eventually provide the foundation for a new drug. It takes years even if all goes well, but it’s one key way that drugs are discovered. (Companies also try to design compounds specifically for certain disease targets instead of doing the mass testing that this type of screening requires.)advertisement About the Author Reprints Pharmaceutical companies amass huge libraries of chemical compounds they can test to see if one just might be capable of being developed into a new drug. By Andrew Joseph Nov. 20, 2015 Reprints @DrewQJoseph Tags AstraZenecadrug developmentSanofi AstraZeneca has shared before with industryAbout four years ago, AstraZeneca and Bayer opened up their libraries to each other, but they only screened the compounds on targets that were not relevant to the other company. (In the AstraZeneca-Sanofi deal, no restrictions were placed on the screening.) One interesting discovery: Scientists from AstraZeneca and Bayer reported in Drug Discovery Today in 2012 that there was little overlap between the two collections, concluding that “one can effectively access a large collection of additional, diverse, high-quality and well-kept screening compounds … [in] the screening collection of a competing pharmaceutical company.”…and with academiaLast year, AstraZeneca launched a partnership with the Academic Drug Discovery Consortium, a network of more than 130 academic drug discovery centers formed in 2012. The consortium does not have its own compound library, and academic institutions may only have a few thousand compounds in their libraries. With the partnership, selected researchers get access to 250,000 of AstraZeneca’s compounds. The compounds are sent to the scientists, who perform the screening on targets they develop. For researchers, the program opens the door to a wealth of compounds, and for AstraZeneca, the company typically gets the first chance to license any promising technology. “A lot of the biology expertise and knowledge about the genes and the disease, that comes largely from academia,” said Matthew Hartman, secretary and treasurer of the consortium.Biotech and pharma will partner with the government as wellRobots at the National Center for Advancing Translational Sciences, an arm of the National Institutes of Health, perform 3 million tests a week of roughly 500,000 compounds on different disease targets. The scientists there regularly work with biotechnology companies who want to study how certain disease targets respond to certain compounds. “They may not have the chemical libraries, they may not have the screening technology,” said Ajit Jadhav of NCATS. The center’s researchers can also help the companies polish the compounds to get them ready for further testing.Europe’s in the gameScientists recently formed the Joint European Compound Library with 321,000 compounds that originated in pharmaceutical companies’ libraries and plan to make 200,000 more compounds in the next four years. The library will be open to academics and biotech companies who otherwise would not have access to such a collection. “The emerging picture of a low chemical similarity between the independent screening libraries suggests that an efficient and cost-effective way to generate a highly diverse library would be to combine the libraries from multiple companies,” scientists wrote in February in Drug Discovery Today. “The combined chemical space explored by all the collections would be available and this would maximize the chances of hits against a novel biological target.”Some pharmaceutical companies are sharing selections, but don’t expect open accessThe compounds remain incredibly valuable to companies. “The library, the chemical compounds, are usually the cherished jewel of the company,” said Barbara Slusher, president of the Academic Drug Discovery Consortium and neuroscientist at Johns Hopkins University. “So they’re still quite reluctant to give that out in an unencumbered fashion.”center_img [email protected] General Assignment Reporter Andrew covers a range of topics, from addiction to public health to genetics. Andrew Joseph BusinessWhy drug makers share their prized compound libraries with competitors Here are six things you should know about compound libraries, and how different groups are trying to leverage them to improve drug discovery.The companies don’t worry about honing in on the same compoundCompanies want to protect their compounds: They spend a lot of money building and acquiring new ones, and they are intellectual property. So what if a compound turns out to be a hit for both Sanofi and AstraZeneca? First off, most hits don’t actually lead to new drugs. And even if both companies pursued the same chemicals, their scientists do so much work creating “lead compounds” and improving them that any resulting drugs would almost certainly not match. “Each of those is just a potential starting point for a drug discovery project,” said Stephen Frye, a former GlaxoSmithKline scientist who now directs the Center for Integrative Chemical Biology and Drug Discovery at the University of North Carolina at Chapel Hill. That’s why the trade between the two companies involves what is known as “precompetitive” research.advertisementlast_img read more

Can you exercise too much?

first_img Related: With iPhone apps, your doctor can read your bathroom scale Modern life has factored exercise out of our lives. I recently took a historical tour of my hometown of Simsbury, Conn. According to the guide, in the 1700s, the average Simsbury resident burned between 4,000 and 6,000 calories a day, chopping wood, hauling water, farming, and the like. Today, most of us burn under 2,000 calories a day. In other words, we need more exercise, not less.advertisement Runners train for the TCS World 10K run in Bangalore, India. Is there an upper limit beyond which too much exercise is harmful? For almost everyone, the answer is no. Manjunath Kiran/AFP/Getty Images Paul D. Thompson Investors bet big on apps that promise to improve health — and cut costs It’s important to keep in mind that the number of people at the upper end of the exercise spectrum in these studies was very small. So the results should be used to generate new hypotheses, not to make recommendations about exercise. Unfortunately, the media attention these studies generated has sown some confusion among the public about the benefits — and hazards — of exercise for preventing heart disease. At the other end of the spectrumI’ve been interested for years in whether too much exercise could somehow offset its cardiovascular benefits. Having run the Boston Marathon 29 times (finishing 16th in 1976), I know how much training is needed to run a marathon or a triathlon, to row or cycle competitively, and the like.In the JACC article, we explored four recent studies that suggest exercising a lot may not be as good for the heart or long-term health as exercising more moderately. In these studies, people who exercised strenuously appeared to lose most of the cardiovascular benefits that exercise provided to more moderate exercisers.advertisement That said, the results are intriguing, and there may be biological explanations for them. For example, endurance activities such as running a marathon stretch the right ventricle — the chamber of the heart that pumps blood to the lungs. This could be hazardous among individuals with a genetic predisposition for a relatively rare condition called right ventricular cardiomyopathy.Overall, though, as a group, endurance and elite athletes who exercise at the upper end of the physical activity spectrum aren’t at increased risk for cardiovascular disease, and tend to live longer than individuals who are sedentary and those who exercise moderately.No upper limit for exerciseOver the years, hundreds of studies have shown that exercise and physical activity are associated with lower rates of heart disease and longer life. We think this is due to exercise itself. But none of these studies has ever been able to exclude the possibility that people who choose to exercise are genetically and physiologically hardier. That might be especially true for endurance and elite athletes.Here’s the bottom line on exercise “dose” and cardiovascular health: Any amount of exercise is better than none. Even something as simple as standing instead of sitting is beneficial. For moderate exercise, like walking, there is no upper limit, although doing it for more than 100 minutes a day doesn’t seem to convey any extra cardiovascular benefit. Vigorous activity, like jogging, can offer large cardiovascular benefits, though doses up to 10 times the recommended amount (about 12 hours a week) don’t have an extra payoff.Paul D. Thompson, MD, is a cardiologist at the Hartford Hospital, where he is chief of cardiology, cardiovascular research, and the Athlete’s Heart Program. He is also professor of medicine at the University of Connecticut. He has received research support or consulted for various pharmaceutical and device companies and has provided expert legal testimony on exercise-related cardiac events and statin myopathy.center_img [email protected] Related: Exercise and good health go hand in hand. Exercise and physical activity have been linked to protection against heart attack, stroke, diabetes, some types of cancer, dementia, and more. A little bit of exercise is better than none, and more than a little is even better. But is there an upper limit beyond which too much exercise is harmful?For almost everyone, the answer is no. As several colleagues and I write in the latest issue of the Journal of the American College of Cardiology (JACC), the main problem in the United States and around the world is too little exercise. One-quarter of Americans don’t exercise at all; only about half hit the weekly recommendation of 150 minutes of moderate exercise (like walking) or 75 minutes of vigorous exercise (like running). About the Author Reprints By Paul D. Thompson Jan. 21, 2016 Reprints First OpinionCan you exercise too much? Tags athletesexerciseheart diseaselast_img read more

A protein that helps keep the heart pumping

first_img @meggophone By Megan Thielking Feb. 9, 2016 Reprints [email protected] Our hearts are constantly pumping blood, and the human body naturally regulates that activity to make sure the same amount of blood flows in and out. Now, scientists have figured out the role a protein called titin plays in that regulatory process. Here’s what lead researcher Pieter de Tombe of Loyola said about the findings, published in PNAS.How is the amount of blood going in and out of the heart regulated?The amount it pumps varies a lot, between me talking to you and me going on a treadmill, and that amount is determined by a regulatory mechanism. But when that regulatory mechanism is broken, the pressure in your heart builds up. Then the pressure in your lungs builds up, your lungs fill with fluid, and that becomes congestive heart failure. What’s the application of that finding?We don’t know exactly what the protein is, but we know that there’s a protein that’s being pulled on as titin is stretched. That’s the smoking gun to figure out what protein is the last step of this regulation — so we could target that protein to improve the length of it and bring the heart back to normal.For more Lab Chats, subscribe to the free Morning Rounds newsletter. News Editor Tags heart diseaseheart failuremedical research Megan Thielkingcenter_img About the Author Reprints And what did you figure out about that regulatory mechanism? If the muscle is a rubber band and you stretch it, it requires a force to do the stretching. … The elasticity of the [heart] muscle is really determined by a protein, titin. In heart failure, the titin is less stiff and becomes a bigger protein. In normal rat hearts with stiff titin, when we pull on the titin, we see some proteins in the heart muscle move to regulate the strength of the heart’s pump. In rats with short titin, we didn’t see it move.advertisement Nearly 80 percent of heart attacks in US are never diagnosed Related: A protein called titin plays a key role in keeping the heart pumping. Hulton Archive/Getty Images Lab ChatA protein that helps keep the heart pumping last_img read more

Genetically modified mosquito plan headed for vote in Florida Keys

first_img Related: The newspaper reported Monday that board members weren’t comfortable with either a district survey that found Key Haven residents supportive of the test or anecdotal complaints from angry residents.advertisement Associated Press About the Author Reprints KEY WEST, Fla. — Residents in the Florida Keys will get to vote on whether genetically modified mosquitoes should be released in their neighborhood.The mosquito control district in the island chain wants the British biotech firm Oxitec to test its modified mosquitoes in a neighborhood of 444 homes clustered on a relatively isolated peninsula north of Key West.At a board meeting Tuesday in Marathon, the district’s board of commissioners decided to allow residents of the Key Haven neighborhood to have a say in the project.advertisement Related: US moves to allow release of genetically modified mosquitoes The vote will be nonbinding, but the Key West Citizen reports that a majority of the five commissioners said they would abide by the will of the voters. By Associated Press April 20, 2016 Reprints Two commissioners are up for re-election, and a third has decided not to run again.Commissioner Jill Cranney-Gage, who is running for re-election and lives in Key Haven, said she wanted an independent survey on the proposed test.“I do not want to shove this down people’s throats,” she said. “I have heard from residents, friends and neighbors, but what I have heard is not significant when it comes to an overall response.”Oxitec, which was bought last year by the biotechnology company Intrexon, modifies Aedes aegypti mosquitoes with synthetic DNA to produce offspring that won’t survive outside a lab. The mosquito species can transmit the Zika virus, along with dengue and chikungunya, to humans.Small field tests in Panama, Brazil, and the Cayman Islands significantly reduced wild Aedes larvae populations in the targeted neighborhoods with no adverse impacts to humans or the environment, Oxitec officials have said.The company is expanding its operations in Brazil to conduct larger tests with its mosquitoes. A similar technique using radiation to sterilize insects has been used for decades to control mosquitoes and other insects.Derric Nimmo, who would oversee the Florida test for Oxitec, said he supports the vote. The test proposed in the Keys would release roughly 3 million modified male mosquitoes into the neighborhood to mate with wild female mosquitoes.“I think a referendum is great, as long as it is done in an independent way,” Nimmo said. “An informed choice is what we want.”Thousands of mosquitoes would be released three times a week for up to 22 months during the test. PoliticsGenetically modified mosquito plan headed for vote in Florida Keys Biologists: Let’s sic ‘gene drive’ on Zika-carrying mosquitoes An Aedes aegypti mosquito is seen through a microscope. Mario Tama/Getty Images The Monroe County Supervisor of Elections Office agreed to oversee the election, and the ballot question will go before voters in the Aug. 30 primary, the district’s attorney, Dirk Smits, said.The district has until June 24 to submit the ballot question, Smits said.Some Key Haven residents who have opposed Oxitec’s plan welcomed the vote. Ed Swift said Tuesday that neither he nor his neighbors want to be “guinea pigs.” The Citizen has reported over 60 signs visible in the neighborhood state that residents do not consent to the test.The US Food and Drug Administration still has to decide whether to allow the test to proceed. The agency’s Center for Veterinary Medicine has released a preliminary finding of no significant impact for the trial, and the public has until May 13 to review and comment on those findings. Tags genetically modified organismsmosquitoespolicyZika Viruslast_img read more

As yellow fever crisis spreads, health officials prepare a major vaccination campaign

first_imgHealthAs yellow fever crisis spreads, health officials prepare a major vaccination campaign @HelenBranswell Senior Writer, Infectious Disease Helen covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development. Health officials in Congo are preparing for a major yellow fever vaccination campaign later this month in hopes of halting the spread of the disease before it creeps into the capital, a possibility that has sparked fears of a much wider epidemic.To stretch limited global supplies of the vaccine, officials in the capital, Kinshasa, plan to use a smaller dose than normal, a proposal that has been endorsed by both the World Health Organization and Congo’s health ministry.But a WHO official told STAT that authorities have considerable work to do before they can set a formal date for the vaccination campaign: securing enough special syringes to deliver a far smaller dose of vaccine, training health workers, and finalizing a public education program.advertisement Yellow fever outbreak ‘serious’ but not a global emergency, WHO says By Helen Branswell July 5, 2016 Reprints Residents of Kinshasa read newspapers with reports of yellow fever. Jean Robert N’kengo/Reuters The Congolese health minister, Felix Kabange, said last week the campaign will include everyone in Kinshasa as well as some people in the provinces of Kwango, Lualaba, and Kasai.Currently, the nearly 2 million residents of the capital of the Republic of Congo, Brazzaville — just across the Congo River from Kinshasa — are not scheduled to be vaccinated.“We are trying to do Kinshasa to avoid Brazzaville,” said Perea. Yellow fever hits Angola hardVolume 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/2016/07/05/yellow-fever-vaccination-campaign-congo/?jwsource=clCopied EmbedCopiedLive00:0000:3600:36  Here’s what you should know about the yellow fever outbreak happening in Angola right now. Hyacinth Empinado/STAT The goal is to get the job done as quickly as possible once the work actually starts, so as to not paralyze other heath activities in the country. Perea said officials hoped to complete the vaccination campaign within two to three weeks.“That will be challenging, but possible,” he said.The yellow fever virus is normally found in forested parts of Africa and South America, where it is transmitted between monkeys and mosquitoes. But it occasionally breaks out of the transmission cycle and starts to infect humans.It is spread by Aedes mosquitoes — the same mosquitoes that transmit the Zika virus.People who contract the virus experience fever, headache, backache, muscle pain, loss of appetite, and nausea, or vomiting. The symptoms typically last three or four days.But after an apparent recovery, about 15 percent of people experience a relapse that spirals them into a second, more severe phase of the illness during which they can develop jaundice. Roughly half of people who develop a toxic phase die, the WHO estimates.Yellow fever has spread into Congo from neighboring Angola, where an outbreak in the capital, Luanda, has expanded to all 18 provinces of the country. The need to mount mass vaccination efforts in Angola has put enormous pressure on the world’s supplies of yellow fever vaccine.An emergency stockpile of 6 million doses of yellow fever vaccine has previously been more than sufficient to quell outbreaks that would flare up.The stockpile is maintained and managed by the WHO, UNICEF, the International Federation of the Red Cross, and Doctors Without Borders. It is paid for by Gavi, the Vaccine Alliance, an international organization that uses private and public money to subsidize vaccination programs for the world’s poorest countries.But so far this year, 19.6 million doses have been delivered or promised through the stockpile. And the outbreaks are still underway.Congo has reported 1,307 suspect and 68 confirmed cases, with 75 reported deaths so far. Many of the cases are imported from Angola; there is substantial movement between the countries. Helen Branswell Vaccination efforts have been concentrated along the countries’ shared border. But a few locally acquired cases in Kinshasa and the fear that the virus could take off in that teeming city — population at least 11.6 million — led to the conclusion Kinshasa should be vaccinated.Global supplies aren’t adequate to give everyone there a full dose. So the WHO’s expert panel on vaccinations has agreed that fractional doses can be given to anyone above 2 years of age.Several studies have suggested smaller doses of the highly effective yellow fever vaccine can still protect against infection. But it’s not known how long that protection will last or whether it will be as protective for infants as it is for adults.So the expert panel recommended everyone who is given a fractional dose should later get another, regular-sized shot as a booster dose. With a regular dose of yellow fever vaccine, one injection is thought to protect for a lifetime.The expert panel also advised that a full dose be used for children under the age of 2. About the Author Reprints Related: To control spread of yellow fever, panel approves WHO plan to ration vaccine “I think we need to think about everything,” said Dr. William Perea, the WHO’s coordinator for control of epidemic diseases unit. “You can never be careful enough.”advertisement Related: If people do not believe the lower dose — one-fifth the normal dose — will be effective, they are likely to try to get vaccinated more than once, putting further strain on supplies. Tags VaccinesWorld Health Organizationyellow feverlast_img read more

“Smart” thread could pluck diagnostic data from your stitches

first_imgQuick Take“Smart” thread could pluck diagnostic data from your stitches By Megan Thielking July 19, 2016 Reprints Can you diagnose disease from the sound of a voice? [email protected] Scientists have woven microscopic sensors into thread to gather diagnostic data from the tiniest of sutures.The smart threads can sense pH, glucose levels, and temperature. They can even ferry tiny amounts of bodily fluids from one point to another for analysis by microsensor. And they can transmit data wirelessly — so they can alert doctors when a patient’s blood sugar is off or an infection is starting to form in a wound.More traditional diagnostic materials — such as monitors and sensors stuck on the skin — can sense changes on the body’s surface, but often can’t penetrate tissue to gather information about internal problems. So a team of engineers from several institutions tossed around ideas for new materials.advertisement Related: Megan Thielking @meggophone Newsletters Sign up for Morning Rounds Your daily dose of news in health and medicine. One proposal stood out: Thread. It can bend, stretch, and be made as thick or as thin as scientists want.“We generated an entire toolkit of these threads,” said Sameer Sonkusale, a professor of electrical engineering at Tufts University and a coauthor of a paper on the new material, published this week in the journal Microsystems and Nanoengineering.advertisementcenter_img The research is still in the early stages — scientists have tested the threads in Petri dishes and a mouse model but have not yet tried them in humans.But they have high hopes that the threads can be a useful tool. They might, for instance, help diabetic patients who have chronic wounds that don’t heal well, Sonkusale noted.“We monitored actual biomarkers of wound healing,” he said.  Leave this field empty if you’re human: Please enter a valid email address. Privacy Policy Smart thread captured under a scanning electron microscope. (Center for Nanoscale Systems — Harvard University) About the Author Reprints News Editor Tags diagnosticsinfectionmedical technologylast_img read more

Also made in Mexico: Lifesaving devices

first_img By Sarah Varney — Kaiser Health News April 3, 2017 Reprints 5 makeshift — and ingenious — ways to improve medical devices When President Donald Trump threatens to redo trade deals and slap steep taxes on imports, he focuses largely on car companies and makers of air conditioners. But the medical devices business makes a particularly revelatory case study of the difficulties of untangling global trade.America imports about 30 percent of its medical devices and supplies. The trouble is, there are barriers to importing the jobs tied to making them. To ensure the safety of products that often end up inside the human body, medical devices are strictly regulated and require lengthy approvals from the Food and Drug Administration and other inspectors.advertisement If the US does approve a border tax, Felix Diaz added, “the final customer is going to pay.”The final tally of just how much American customers — hospitals, clinics, nursing homes and doctors’ offices — would pay is unclear. Trump and Republican lawmakers have yet to release a detailed plan on trade tariffs or corporate tax reform.In addition, the final price on many medical devices is negotiated by group purchasing organizations, which harness the purchasing power of hospitals and others and would try to mitigate any price increases.Mike Alkire, chief operating officer at Premier, which negotiates for some 3,750 American hospitals, said that while prices would initially spike if the Trump administration hit countries like Mexico or China with tariffs, “we’ve got enough diversity in the way we source products, we think we can manage the costs.”“Over the long term,” Alkire added, “we do think the market will stabilize and the most efficient place to produce products will occur.”Chief executives at some of the United States’ largest hospitals have nervously watched the gathering legislative, economic and geopolitical storm. The executives say this concern on trade is based on simple math.In Chicago, Cook County’s public clinics and hospitals spend $62 million a year on medical supplies, including 120,432 boxes of gloves, 44,434 boxes of syringes and 403,460 bags of fluids. Safety-net hospitals that care for poor patients would be unable to pass along price increases because the programs that insure those patients, Medicaid and Medicare, pay fixed rates for care.“It’s a bunch of dominoes,” said Doug Elwell, deputy chief executive for finance and strategy at the county hospital system. Private or for-profit hospitals, because they serve largely privately insured patients, “can pass along 10 percent in the bill,” he said. “But we can’t.” If the US does approve a border tax, “the final customer is going to pay.” BusinessAlso made in Mexico: Lifesaving devices About the Author Reprints American hospitals rely on heaps of bandages and surgical gloves from China, suturing needles and artificial joints from Ireland, and defibrillators and catheters from Mexico. In all, the annual imports of medical devices more than tripled from 2001 to 2016, reaching $43.9 billion, according to BMI Research, a unit of the Fitch Group.Mexico is the leading supplier, ahead of Ireland, Germany and China. And few places illustrate this changing landscape, or help explain the complexity of the industry, as well as Tijuana, 20 miles south of San Diego.The city houses the highest concentration of Mexico’s medical device firms, 70 percent of which are American-owned, according to the local development group. Companies including Medtronic, CareFusion, DJO Global and Hill-Rom-Welch Allyn — some that have their headquarters just up the road in San Diego — have invested heavily in Tijuana, constructing long, low-slung factories tucked into the hilly terrain. Giant banners hanging from manufacturing plants plead for workers to join them.The high-tech operations emerged after NAFTA helped transform Mexican border factories, known as maquiladoras, into industrial powerhouses. Now, instead of being garment sweatshops, many maquiladoras in Tijuana employ a new generation of Mexican engineers and skilled technicians to make orthopedic devices, surgical equipment and catheters. The factories have helped remake the city’s reputation from a ribald party town to a locus of sophisticated industrial manufacturing. Roadside shanties made of corrugated metal and plastic abut new apartment complexes painted fuchsia and lime green; late-model SUVs bounce along potholed roads. Workers pass through imposing security gates to begin shifts operating advanced machinery or delicately sewing pig tissue onto stents for heart valves, and trucks zip in a steady line across the border in preclearance, fast-track lanes into California.But the possibility of new protectionist trade policies is already looming over this buzz of activity. The question for many people here is whether it will upend the economic incentives that led American companies to invest in the city in the first place.Trump has argued that a border tax is needed to keep well-paying jobs in the United States and dissuade companies from relying on Mexican workers who earn a small fraction of American wages. Technicians at medical device factories in Tijuana earn about $14 an hour, compared with about $25 an hour for technicians at factories in the US.Critics of Mexico’s maquiladoras system contend that wages are kept unfairly low and that workers have been kept from organizing. For companies, though, the savings are clear — as much as 45 percent for labor-intensive products — and have helped fuel the wave of development here.Now, even the city’s unflappable longtime entrepreneurs are unsettled by the shift in trade talk.American companies draft plans to build plants — or expand existing ones — years in advance, said Miguel Felix Diaz, vice president of the Baja California Medical Device Cluster, an organization that represents 63 medical device manufacturing plants that employ 60,000 Mexican workers.“For that reason now,” he said, “you don’t know if you start some operation tomorrow how it’s going to be affected.” A border tax, experts say, would ricochet back and forth across the US-Mexican border — and around the world — in unintended ways.Mexico’s medical device industry buys much of its raw materials and capital machinery from American suppliers. The American-owned Integer plant in Tijuana, for example, buys 90 percent of its raw materials, essentially duty-free, from the US: stainless steel to be stamped into cups used for hip replacements and plastic to be molded into catheters. Then half of the factory’s output is shipped back to the USA and much of the rest to Puerto Rico and American-owned companies in Switzerland and Singapore.If Mexico imposes tariffs on raw materials from American suppliers, a likely response to any border tax imposed by the US, production costs would spike for companies in Mexico or those companies would shift to suppliers in other countries eager to cut low-tariff deals, like China. Imports from China contain around 4 percent of content from the US, while imports from Mexico contain about 40 percent, and even more in products like medical devices.“The damage wouldn’t just be to the Mexico operation, it would be to US suppliers,” said Christopher Wilson, deputy director of the Mexico Institute at the Woodrow Wilson International Center for Scholars.Companies would also face a regulatory thicket should they move or change suppliers.The FDA inspects and certifies hundreds of medical device manufacturers in China, Europe, Mexico and elsewhere, and even minor manufacturing changes must be certified, a process that can take many months.“Medical devices is a very stringent process,” said Jorge Hernandez, director of operations at Integer in Tijuana, an American-owned company that makes components for pacemakers and defibrillators, among other devices.The Integer plant in Tijuana that Hernandez oversees looks like a vast scientific laboratory. Behind glass windows, in so-called clean rooms, employees in blue hair caps and bootees tend to machines that process gold and platinum into tiny components for pacemakers. In one room, workers sit shoulder to shoulder, peering into microscopes as they expertly remove tiny debris from freshly made parts. Even the smallest change in these manufacturing protocols would require a new inspection. Related: TIJUANA, Mexico — The North American Free Trade Agreement has transformed this sprawling and gumptious border town from a gritty party spot to something entirely different: a world capital of medical devices.Trucks choke boulevards lined with factories, many bearing the names of American-born companies: Medtronic, Hill-Rom, DJO Global and Greatbatch Medical. Inside, Mexican workers churn out millions of medical devices each day, from intravenous bags to artificial respirators, for the global market.Nearly all Americans with pacemakers — and people worldwide — walk around with parts from here.advertisementcenter_img Related: Trump proposes shuttering NIH program that promotes medical research overseas Integer’s legacy company, Greatbatch Medical, opened the plant in 2005. Over the years, the company consolidated some of its manufacturing from Carson City, Nev., and Columbia, Md., to Tijuana, drawn by the lower wages and the pool of skilled technicians graduating from Mexican universities.The company, like many others here, is seamlessly integrated: Employees in Tijuana connect via videoconferences with research and development teams in the US to fine-tune product designs. The border seems like a quaint historical footnote.“People need to understand this relationship we have goes both ways,” said David Mayagoitia, president of the board of the Tijuana Economic Development Corp.Sitting inside an office in a modern glass-and-concrete building in downtown Tijuana, Felix Diaz said Mexicans and Americans had built strong relationships.“We are dealing daily, we are eating together, we drink a couple of tequilas,” he said. “We don’t want to start any commercial war.”This story was originally published on Kaiser Health News.  Sarah Varney — Kaiser Health News My daughter is fighting a rare disease. A ‘streamlined’ FDA won’t help her As a result, any tariff tinkering by the Trump administration could jolt not only the devices industry in coming years but health care nationwide.Here in Tijuana, the factories are bound to stay put for years, at least. During that time, health executives say, a border tax could fracture the industry’s sophisticated global supply chain and force American hospitals to pay more for vital necessities — or worse.“The real danger is the supplies won’t be available at all,” said Dr. John Jay Shannon, chief executive of the Cook County Health and Hospitals System in Chicago. Some of Medtronic’s replacement heart valves are manufactured in Mexico. Susan Walsh/AP Miguel Felix Diaz, vice president of the Baja California Medical Device Cluster Related:last_img read more

Scientists are getting proactive about self-corrections

first_img Why is it so damn hard to get a paper retracted? Journals pin corrections on scientific articles for all sorts of reasons — from the mundane, like minor typos and wording changes, to the significant, such as errors that warrant a detailed explanation.But the process for correcting a published article can be needlessly burdensome and time-consuming, and stories abound of scientists trying to do the right thing, noting a minor error or update to their own work, but facing hurdles — from delays to flat out denials from journals.Now, some researchers have decided to take matters into their own hands, using a comment feature on the widely used PubMed site. Why, after all, should readers wait to learn of updates, and, in the case of potentially serious flaws that might affect scientific conclusions, continue chasing what are likely to be dead ends that could be easily turned around with new information?advertisement Inti Ocon/AFP/Getty Images Related: Another group of researchers who noticed several errors in their 2012 article in the Journal of Clinical Endocrinology and Metabolism did double diligence — getting the journal to correct the article, and then commenting on PubMed Commons to share a link to that correction.Those actions are important because PubMed has, over the decades, become the leading gateway for biomedical research. It’s very likely that a scientist will find an abstract on PubMed, rather than finding it somewhere else first.As we and others have argued for some time now, scientific papers are not monuments cut from stone that, once published, cannot and should not alter. In our view, readers’ and researchers’ use of social media and online forums to point out flaws in articles is a good thing. It means the system relies less on editors and journals as gatekeepers to concerns being made public. And many editors and journals don’t seem all that interested in addressing such issues, a large part of the reason that PubPeer was created.A close cousin, philosophically, is an idea dreamed up by some journal editors and other scholars to allow authors to amend their own papers. Under the proposed system, laid out earlier this month, researchers would have the opportunity to tag their articles with “amendments” about mistakes or other issues ranging from “insubstantial” to “complete” — the functional equivalent of a retraction. Indeed, the system is designed to replace the “correction” and “retraction” regime. One researcher they cite is Garret Stuber, a neurobiologist at the University of North Carolina. In February, just days after publishing a paper in Nature Neuroscience, Stuber realized that some images had been duplicated during the back-and-forth with the journal. In addition to writing to the journal, he turned to PubMed Commons to let others know about the issues, in “an effort for immediate notice and transparency to what occurred,” he told Retraction Watch. “I thought that this would be the best course of action in order to avoid any further confusion.”advertisement Why science would benefit from being self-refereed Although calling the phenomenon a trend might be a bit premature, a new article by the team behind PubMed Commons — a government-hosted forum that lets users comment on papers in the Medline database — notes with enthusiasm the recent increase in the number of researchers who have used the site to alert readers to potential problems with their work. Related: The WatchdogsScientists are getting proactive about self-corrections By Ivan Oransky and Adam Marcus April 13, 2017 Reprints The advantage of the approach, according to proponents, is that letting authors take charge of post-publication quality control will speed the whole thing up. Journals are bogged down by procedural issues, production demands, and other constraints — including lawyers, when editors are alleging fraud — that make them about as nimble as a cruise ship on an America’s Cup course.Of course, opponents might argue that these approaches leave too much in the hands of authors while undermining the expertise of journals and editors in handling such matters. We’re sympathetic — to a point. We can certainly envision a scenario in which unscrupulous authors dupe their peers by suggesting that their errors are benign. Daniele Fanelli, who called for “self-retractions” as a way to clean up the literature, anticipated that potential problem, too.So, some open questions linger. What’s not an open question, though, is that science needs to be self-correcting — and the current way that works just isn’t working anymore. Tags researchlast_img read more

World Health Organization tries moving closer to creating a ‘fair pricing’ model

first_imgPharmalot What’s included? Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. World Health Organization tries moving closer to creating a ‘fair pricing’ model Fabrice Coffrini/AFP/Getty Images [email protected] Fresh from a meeting with drug makers, advocacy groups, and government agencies, World Health Organization officials say they are gradually moving closer to a framework for so-called fair pricing for prescription medicines.Although recommendations are not yet forthcoming, the latest meeting builds on efforts that began a year ago and, at the time, identified several key issues to be addressed. A report by an informal advisory group last fall named transparency in pricing and research and development costs; the right of governments to issue compulsory licenses; manipulation of orphan drug designations; medicine shortages; and the merits of value-based pricing. What is it? Ed Silverman About the Author Reprintscenter_img Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED Tags drug pricingpharmaceuticalsSTAT+ 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. GET STARTED By Ed Silverman May 11, 2017 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. @Pharmalot Log In | Learn More last_img read more

Novartis buying AveXis for $8.7 billion to strengthen gene therapy capabilities

first_imgPharma About the Author Reprints [email protected] Adam Feuerstein GET STARTED By Adam Feuerstein April 9, 2018 Reprints @adamfeuerstein Log In | Learn More Tags biotechpharmaceuticals Novartis buying AveXis for $8.7 billion to strengthen gene therapy capabilities Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Senior Writer, Biotech Adam is STAT’s national biotech columnist, reporting on the intersection of biotech and Wall Street. He’s also a co-host of “The Readout LOUD” podcast. Novartis is acquiring AveXis for $8.7 billion to strengthen its gene therapy unit, adding a promising but still experimental treatment targeting a fatal childhood disease.AveXis, a small biotech based in a north Chicago suburb, is being purchased for $218 per share, or an 88 percent premium to Friday’s closing stock price, Novartis said. 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? What is it? 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.last_img read more