FDA slams another Indian drug maker for serious quality problems

first_img Ed Silverman If there is a surefire way to arouse the concerns of Food and Drug Administration inspectors, try this: take a notebook listing manufacturing problems, place it in plastic bags along with other paperwork, and toss them in a nearby scrap yard where the inspectors can find them.Here’s another approach: leave “unofficial notebooks,” which are used to track manufacturing activities, lying around an office so the inspectors can read how bacteria is present in the water system, but become puzzled when the problem is not cited in official company records.These were just two of several “serious breaches” of good manufacturing practices the FDA cited in a Dec. 23, 2015, warning letter sent to Cadila Healthcare, one of India’s largest drug makers. The letter followed agency inspections of two manufacturing plants in India between August and December 2014.advertisement [email protected] Several companies have also been hit with so-called import alerts in which the FDA bans products made at a specific facility. The crackdown, however, has alarmed Indian drug makers. They have complained the FDA has singled them out for especially tough inspections, which occur too frequently and haphazardly, depriving them of the opportunity to make substantive changes.The ongoing problems prompted several congressional lawmakers last month to ask the US Government Accountability Office to review FDA oversight of foreign manufacturing plants.Last year, the FDA began considering a new approach to inspecting manufacturing facilities in India. The plan is to “allow our inspectors to document where a firm’s quality management system exceeds what would be required to meet regulatory compliance,” FDA officials wrote in a blog post. “To put it simply: the inspections can yield also carrots, and not just sticks.”The FDA has also begun working with the Indian government to bolster domestic oversight. Right now, the agency has three inspectors who work in the country, but others regularly travel there as well, so the total number varies. India’s drug makers, however, are angry over the FDA scrutiny, which has led to a series of import alerts that ban products from being shipped to the US. Tags drug makersFDAwarning letter Meanwhile, nine consumer complaints were lodged by way of pharmacies and distributors over potential product mix-ups. But while Cadila conceded some drugs were made on adjacent production lines, the company never completed its investigation. Were mix-ups caused by inadequate cleaning, unsuitable equipment, material flow, or something else? Cadila didn’t know, which made it hard to fix the problem.There’s more. Several batches of active pharmaceutical ingredients failed an analysis, but Cadila never explored why this occurred. The drug maker also failed to prevent unauthorized access or changes to data. FDA inspectors noted a lab manager could delete data from software and, in fact, one file was deleted. But an audit trail function was never activated and Cadila did not have records of any changes.For its part, Cadila issued a statement to the Bombay Stock Exchange last week to maintain that it takes “quality and compliance matters very seriously … and is working hard to ensure that the commitments made to the FDA are fully completed.” The drug maker also insisted its products are safe and effective and that no products shipped to the United States are made with ingredients from the plant where the analyses failed.“This has a theme found in a lot of warning letters, especially warning letters issued to Indian companies,” said Vince Suneja, chief executive of TwoFour Insight Group, a consulting firm that works with Indian drug makers. “There’s a failure to properly investigate problems and a lack of adequate controls for data.”Indeed, as we have noted previously, this is only the latest instance in which the FDA has scolded an Indian drug maker or ingredients supplier for quality control problems. Over the past several years, in fact, there has been mounting concern over the safety of the pharmaceutical supply chain after the agency cited several companies for production failures.The most notable example was Ranbaxy Laboratories, which is now owned by Sun Pharmaceutical. The drug maker has been a poster child for manufacturing problems. Last year, Ranbaxy paid a $500 million fine to US authorities as part of a settlement that included pleading guilty to two charges of violating drug safety laws that, for example, involved manipulating data. What else concerned the FDA?There were problems with the potency of warfarin made at one plant and Cadila agreed to temporarily suspend production. But after running tests, the company resumed production in November 2014. Yet in June 2015, Cadila acknowledged to the FDA that problems with some lots of warfarin were subsequently found, but had been shipped anyway.advertisement Review of FDA oversight of Asian drug plants requested by lawmakers Related: French proposal for ‘Made in EU’ labels threatens to divide drug industry PharmalotFDA slams another Indian drug maker for serious quality problems About the Author Reprints India’s Cadila Healthcare has run into trouble with the FDA. FDA Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Related: @Pharmalot By Ed Silverman Jan. 6, 2016 Reprintslast_img read more

7 ways to tell if ‘cancer moonshot’ is legit, or political rhetoric

first_img Senior Writer, Science and Discovery (1956-2021) Sharon covered science and discovery. By Sharon Begley Jan. 14, 2016 Reprints Sharon Begley Early on, said Visco, “we realized that the most important thing is to identify people who are willing to put aside their own agenda [for their pet research ideas] and are capable of responding to a bold challenge. We figured out that if you keep going to the same scientists and the same thought leaders, nothing is going to change: they’re very invested in continuing to do what they’ve been doing.” A cancer moonshot will have to make some people mad.2. Is there a real deadline?John F. Kennedy set one for the original moonshot — “We choose to go to the moon in this decade,” he said in 1962. “If you’re going to call it a moonshot, at least be historically accurate,” said pharma consultant Frank Calzone, a former science director at biotech giant Amgen and an advisor to Artemis. “You need a deadline and milestones.”Those make academics “very uncomfortable,” he said, “since in academia you never reach the end — you’re always supposed to ask more questions — and if deadlines are missed, you risk causing the perception that [you] failed.” But without setting out a plan to accomplish X by one date and Y by another, there is less sense of urgency and curing cancer becomes a never-ending quest.3. Is Biden’s moonshot at least doing the easy things?Determining tumors’ genetic profile in order to find a drug that targets the cancer-driving genes has been far from a home run (or moon landing, to stick to the metaphor of the moment), though it does help some patients. One reason is that few patients get their tumors tested. The trouble is, Medicare and many private insurers generally don’t cover tumor genetic profiling.“One of the things the vice president could usefully do is talk to people at [Medicare] and make sure they’re doing their utmost” to expand such coverage, said Dr. Harold Varmus, who stepped down as director of the National Cancer Institute last year and is now at Weill Cornell Medical Center in New York. “The vast majority of cancer patients are not getting genetic testing of their tumors, but doing so would really move things forward.”It might not have an instant clinical payoff — one 2015 study questioned the whole premise of matching tumor mutations to drugs — but would accelerate discoveries in gene-to-drug matching. Private payers generally follow Medicare’s lead.4. Is it not duplicating what’s already being done?Is the moonshot doing things that aren’t already being done in academic, pharma, and biotech labs? Cancer research has undeniably led to meaningful progress, so much so that physicians and scientists are sometimes willing to use the fraught word “cure.” “What we should worry about is if [Biden’s program] just spends more money on the kind of research that’s already happening,” said Calzone. “That’s not a moonshot.”5. Does the program emulate venture capitalists?Venture capitalists figure that nine out 10 investments in startup companies will fail but one will return a zillion-to-one payout. “Back in 2010, people who thought immunotherapies would work against cancer were all in the crazy room at scientific meetings,” Calzone said. They struggled to get government funding, and the National Cancer Institute still rejects most funding requests for high-risk research, though the agency says it’s getting less risk-averse.NCI “would never fund something like Artemis,” said cancer geneticist Yaniv Erlich of Columbia University, who is part of that project. “But you need crazy ideas and radical thinking if you want to reach ambitious goals.” For instance, Artemis participant Stephen Johnston of Arizona State University is developing a vaccine to prevent breast cancer. It’s such a long shot that NCI rejected his grant proposal twice.With support from Visco, who helped get him funding from the Pentagon’s breast cancer research program, Johnston has identified 21 antigens (molecules on the surface of cancer cells that the immune system targets) “found on any breast tumor that might arise,” he said. If the vaccine works, the immune system would target these antigens and destroy the very first malignant cell long before it multiplies out of control and produces a tumor.Johnston will test the vaccine in 700 healthy dogs starting this spring. “I can’t guarantee you this will work, but I can’t see any scientific reason why we shouldn’t try it. Fran [Visco] wants to eradicate cancer and I do, too. A prophylactic vaccine is the only way to do that. This country should be able to afford support for research that has the potential for an enormous payoff even if there’s a risk it won’t work.”6. Does the program bang heads together?Biden talks a good game about collaboration and breaking down silos, so it will be telling to see if that happens. The lack of true collaboration, where researchers share data before they publish, or try to patent, discoveries, “is a real barrier to progress,” Visco said. “We made it clear to everyone that that wasn’t going to happen [in Artemis]. If they weren’t going to share, they weren’t going to participate.”Artemis parted ways with scientists at one institution who were more concerned about claiming priority, and possibly patents, than with pushing the research ahead as fast as possible. And a number of experts said leading cancer centers that do DNA profiling of their patients’ tumors hoard data on how those patients fare, slowing progress.7. Does it involve scientists outside cancer biology?Artemis has virologists, and microbiologists, and computer scientists, and more. “By getting people from different domains and putting them together, you get creative ideas,” said Columbia’s Erlich. Or as Visco put it, “you need a process, and you need people, that allows for wild-ass ideas.” About the Author Reprints Cancer experts will be looking to see whether Vice President Biden’s call for a cancer moonshot can truly transform research. NASA/Liaison @sxbegle center_img Veterans of the nation’s long, difficult slog against cancer are watching closely as Vice President Joe Biden visits the University of Pennsylvania Friday to launch a campaign that — as President Obama put it in his State of the Union address Tuesday — “cures cancer once and for all.”As Biden starts shaping the “cancer moonshot” — inspired by his son Beau’s death from brain cancer last spring — leaders of the cancer research community are wondering whether the project will be a truly bold leap forward, or just business as usual, bringing, at most, incremental progress. Here’s what the experts said, in interviews this week, they will look for:1. Is the science establishment calling for his head?Fran Visco, the founder and president of the National Breast Cancer Coalition, is more than five years ahead of Biden. In 2010, she launched an audacious effort to end — really end — breast cancer. She intends to do this by organizing and securing funding for research to discover, by 2020, both a preventive vaccine and a way to eliminate breast cancer deaths, which almost always occur after cancer metastasizes from the original site.advertisement Critics called her Artemis Project (named for the Greek goddess, twin sister of Apollo, as in NASA’s lunar missions) “harmful to public trust,” “long on aspiration and short on scientific detail,” and impossible. Some of the scientists Visco approached to be part of Artemis “thought we were nuts,” she said. If Biden’s program doesn’t upset some people, she added, that will be an indication it’s just doing more of the same rather than reaching for the heavens.“The same” has certainly made significant advances lately, as drugs that take the brakes off the immune system seem to cure some patients’ melanoma and non-small cell lung cancer, for instance. And with gene-targeted therapies, “90 percent of patients with chronic myeloid leukemia are cancer-free forever,” said Dr. Brian Bolwell of the Taussig Cancer Institute at the Cleveland Clinic. But targeted therapies, overall, are falling short of their promise, there is essentially no treatment for cancers that spread beyond the tumor’s original site, and the only preventive vaccine is for virus-caused cervical cancer.advertisement [email protected] In the Lab7 ways to tell if ‘cancer moonshot’ is legit, or political rhetoric Tags breast cancercancerJoe Bidenlast_img read more

FDA chief aims to recruit 100 million Americans for precision medicine research

first_img Precision medicine helped him beat cancer. Now he’s leading Obama’s initiative SAN FRANCISCO — Uncle Sam wants you to turn over your health records. And Dr. Robert Califf, the cardiologist who now runs the Food and Drug Administration, is determined to make that happen.The Obama administration has set a goal of recruiting 1 million volunteers to hand over their genetic and health data, as part of the $215 million Precision Medicine Initiative.Califf thinks that’s far too modest an ambition. “Let’s think in terms of 10, 20, or 100 million,” he said in an interview with STAT here at a global biotech convention.advertisement Newsletters Sign up for Morning Rounds Your daily dose of news in health and medicine. Privacy Policy By Meghana Keshavan June 7, 2016 Reprints Please enter a valid email address. Biotech Correspondent Meghana covers biotech and contributes to The Readout newsletter. @megkesh The Precision Medicine Initiative will ultimately generate a massive amount of genetic data (particularly if Califf gets his 100 million volunteers on board) — and that will be difficult to decipher. Dr. Francis Collins, director of the National Institutes of Health, often says that only 1 percent of the vast volume of DNA sequenced each year is actually understood. What is precision medicine?Volume 90%Press shift question mark to access a list of keyboard shortcutsKeyboard ShortcutsEnabledDisabledPlay/PauseSPACEIncrease Volume↑Decrease Volume↓Seek Forward→Seek Backward←Captions On/OffcFullscreen/Exit FullscreenfMute/UnmutemSeek %0-9 facebook twitter Email Linkhttps://www.statnews.com/2016/06/07/califf-precision-medicine/?jwsource=clCopied EmbedCopiedLive00:0000:3900:39  Hyacinth Empanado / STAT The precisionFDA tool is aimed at encouraging diagnostics companies, in particular, to set aside their competitiveness and work together. Currently “hundreds” are working on the precisionFDA platform, Califf said.The tool also allows for reality checks like a recent “consistency challenge,” which asked several rival diagnostic companies to try their hand at deciphering a portion of one genome. The FDA’s goal: To see how consistent they were in their interpretations, and how their results matched up against what was previously known about that particular DNA segment.(The winners, announced last week: Sentieon of Mountain View, Calif., for “best performance and highest reproducibility,” and a scientist from Sanofi-Genzyme for “highest accuracy.”) Win McNamee/Getty Imagescenter_img About the Author Reprints Leave this field empty if you’re human: Califf’s call for more collaboration is echoed in the White House. Vice President Joe Biden on Monday urged the 30,000 oncologists at this week’s American Society of Clinical Oncology annual meeting to collaborate in the search for a cancer cure.“I’ve been involved for a long time in medical informatics, and the amount of information that needs to come together in various times and places to get sequenced is profound,” Califf said. PoliticsFDA chief aims to recruit 100 million Americans for precision medicine research Meghana Keshavan Tags FDApolicyprecision medicineRobert Califf [email protected] And that’s not his only goal: Califf is also calling on life sciences companies to share information about the genetic data they collect and analyze in the quest to develop new treatments.To accomplish that, Califf is touting a new tool: precisionFDA. It’s an online, cloud-based portal that was launched this past December, offering scientists from academia, industry, and the government a common space to work together. (It was first dreamed up about six years ago, before Califf joined the FDA, but he said he’d heard it had been greeted with derision: “At the time, people were like, ‘What is this guy doing, smoking pot?’”)advertisement Related:last_img read more

Mylan CEO accepts full responsibility for EpiPen price hikes, but offers little explanation

first_imgPharmalotMylan CEO accepts full responsibility for EpiPen price hikes, but offers little explanation Anger at EpiPen prices channeled at Mylan CEO in congressional hearing Ed Silverman However, Bresch did not offer a breakdown of the billion-dollar investment she cited, such as the extent to which those dollars may have included the cost of its lobbying campaign to win wider access to school districts. It’s also unclear whether the $1 billion also covered regulatory fees or marketing expenses associated with widening the EpiPen franchise.To bolster her statement on transparency, she said, “The current system was not built on the idea of consumer engagement … but it’s where health care needs to move. There are unintended consequences when the patient goes to the pharmacy counter and doesn’t know what the price will be … transparency would improve this.”These are essentially the same arguments that Bresch has made for months after criticism of EpPen pricing transformed Mylan into the latest poster child for pharmaceutical greed. Since then, the company has made plans to sell its own authorized generic version of EpiPen at roughly half the price. And Mylan said it agreed to a $465 million settlement with the Department of Justice for shortchanging Medicaid over rebates, although several lawmakers criticized the deal. Federal authorities have never actually confirmed the deal happened.Meanwhile, the Federal Trade Commission was asked by various lawmakers to investigate whether Mylan violated antitrust laws because the contract for one option in the discounted school program, at one time, contained a clause forbidding school districts to buy rival products. The FTC has only said it is aware of these concerns. Mylan to pay $465 million to settle claims of shortchanging Medicaid About the Author Reprints Related: Mylan CEO Heather Bresch at a September congressional hearing over EpiPen price increases. Pablo Martinez Monsivais/AP [email protected] center_img Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Tags drug pricinginsurancepharmaceuticals “We invested more than $1 billion to create access and awareness and improve the product,” she said during the industry conference. “There’s a lot of misinformation out there, but we now reach 80 percent more patients than when we acquired EpiPen,” about a decade ago. “The idea that there was no advancement in the product was inaccurate.” In a rare appearance since the EpiPen controversy flared this summer, Mylan Pharmaceuticals CEO Heather Bresch accepted “full responsibility” Thursday for the price hikes that caused national outrage.“If EpiPen had to be the catalyst to show what hardworking families are facing, it will have been worth it,” she said at the Forbes Healthcare Summit in New York, referring to the upfront costs that many people encounter with high-deductible health plans. Mylan increased the price of an EpiPen two-pack nearly 550 percent to $608 over the past decade.But, Bresch reiterated remarks she made about the price of EpiPen at a congressional hearing in September, citing a lack of transparency in the pharmaceutical pricing system for the controversy surrounding the product. She justified the price increases by pointing to what she insisted were “investments” made to improve the device and patient access.advertisement @Pharmalot Bresch argued the company redesigned the emergency allergy device so that patients would not stick themselves with the needle. And as part of the effort, Mylan broadened patient access by working to make the device available to schools across the country, which included donating about 700,000 EpiPens. “Over the years, we balanced that innovation by building awareness,” she said.advertisement Related: By Ed Silverman Dec. 1, 2016 Reprintslast_img read more

‘Like a slap in the face’: Dissent roils the AMA, the nation’s largest doctor’s group

first_img Judy is a STAT correspondent based in Denver. Even before the recent election, physicians felt perched on a precipice.Changes sweeping health care have threatened their independence, income, and influence. An epidemic of burnout and depression shadows the profession. And the incoming Trump administration promises still more upheaval. Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Politics Mike Reddy for STAT Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. Log In | Learn More 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. What’s included? @judith_graham By Judith Graham Dec. 22, 2016 Reprints GET STARTED ‘Like a slap in the face’: Dissent roils the AMA, the nation’s largest doctor’s group Judith Graham About the Author Reprints Tags hospitalsinsuranceMedicaidphysicianspolicyWhite Houselast_img read more

Dana-Farber must rethink its decision to keep its fundraiser at Mar-a-Lago

first_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. JIM WATSON/AFP/Getty Images STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. About the Author Reprints Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Tags hospitalsWhite House Dana-Farber must rethink its decision to keep its fundraiser at Mar-a-Lago @colleenmfarrell I am learning to be a healer. After I earn my MD this spring and begin caring for patients as a physician, I will want all of my patients to know that no matter their nationality or their faith, I welcome them, value them, and will care for them.Two weeks ago, President Trump signed an executive order barring refugees and citizens from seven Muslim-majority countries from entering the US. The order clashes with a core value of medicine, that all patients are welcome and deserving of medical care. I am troubled that Dana Farber Cancer Institute, one of Harvard Medical School’s teaching hospitals, is not fully living up to these values. What’s included? By Colleen M. Farrell Feb. 10, 2017 Reprints Log In | Learn More Colleen M. Farrell What is it? First Opinion [email protected] GET STARTEDlast_img read more

Grassley probes EpiPen rival over its $4,500 list price

first_img Log In | Learn More Grassley probes EpiPen rival over its $4,500 list price [email protected] PRNewsFoto/Sanofi/AP What is it? Ed Silverman GET STARTED Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Pharmalot STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.center_img 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 Ed Silverman March 8, 2017 Reprints About the Author Reprints For the second time in recent weeks, a small, privately held drug maker with a piece of the action in two hot markets is being scrutinized by lawmakers over its pricing.In the latest episode, US Senator Chuck Grassley (R-Iowa) wants Kaleo to explain why it set a $4,500 list price for the Auvi-Q allergic reaction device that is competing with EpiPen. The move is actually part of a complicated pricing strategy that may appeal to some consumers, but not so much to insurers. Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED What’s included? @Pharmalot Tags drug pricingpharmaceuticalsSTAT+last_img read more

Cherokee Nation files lawsuit targeting CVS and other pharmacies in opioid crisis

first_img Tags addictionHealth Disparitieslegalopioidspharmaceuticalsstates Jeff Lautenberger/Tulsa World via AP News Editor Cherokee Nation is suing CVS Health, Walgreens, and other drug companies and retailers, alleging the companies didn’t do enough to stop prescription painkillers from flooding the tribal community and creating a crisis of opioid addiction.The lawsuit, filed in tribal court on Thursday, alleges that the companies failed to properly monitor opioid prescriptions and orders. The tribal government alleges that those patterns should have raised red flags that the companies are legally responsible for reporting to federal officials.“These drug wholesalers and retailers have profited greatly by allowing the Cherokee Nation to become flooded with prescription opioids,” the lawsuit alleges. “They have habitually turned a blind eye to known or knowable problems in their own supply chains.”advertisement Related: By Megan Thielking April 20, 2017 Reprints ‘It can tear a family apart’: The opioid crisis sweeps through Cherokee Nation Newsletters Sign up for Morning Rounds Your daily dose of news in health and medicine. “As we fight this epidemic in our hospitals, our schools, and our Cherokee homes, we will also use our legal system to make sure the companies, who put profits over people while our society is crippled by this epidemic, are held responsible for their actions,” Cherokee Nation Principal Chief Bill John Baker said in a statement.There have been a slew of lawsuits filed by local governments accusing drug makers of contributing to the opioid epidemic by downplaying the addictive properties of painkillers and improperly encouraging doctors to prescribe the drugs.In February, for instance, Erie County, N.Y., sued four companies — Purdue Pharma, Johnson & Johnson’s Janssen unit, Teva Pharmaceuticals, and Endo International — for costing the county government millions of dollars each year to fight the opioid crisis.“The goal is to get justice for the Cherokee Nation and to recover the extraordinary losses they’ve suffered as a result of the opioid epidemic,” said Fields.Correction: A previous version of this story incorrectly asserted that Cherokee Nation’s suit was the first in the US to target pharmacies. Megan Thielking [email protected] Please enter a valid email address. Related: The rate of drug-related deaths among American Indian and Alaska Native people has nearly quadrupled since 1999, according to the Indian Health Service. It’s now double the rate in the US as a whole. Oklahoma — home to most of the 120,000 citizens of Cherokee Nation — leads the country in prescription painkiller abuse.Cities and counties across the US have filed similar lawsuits against drug companies. West Virginia included several pharmacy chains as well in a case brought against opioid distributors. But this is the first case brought by a tribal nation seeking to hold those dispensing prescriptions responsible for an epidemic of opioid addiction.advertisement Leave this field empty if you’re human: Privacy Policy About the Author Reprints No opioids, please: A growing movement lets patients refuse prescriptions @meggophone In a statement to STAT, CVS Health said it has “stringent policies, procedures and tools to ensure that our pharmacists properly exercise their corresponding responsibility to determine whether a controlled substance prescription was issued for a legitimate medical purpose before filling it.”Walgreens declined to speak on pending litigation.Under the Controlled Substances Act, pharmacies and drug distributors are legally responsible to flag federal officials when they see suspicious orders or prescriptions for controlled substances such as opioids.Those suspicious orders can take several forms. They could involve patients filling multiple opioid prescriptions from different doctors — known as “doctor shopping” — or an order for opioids that’s disproportionately large for the local population.“Pharmacists have a duty only to fill scripts that are for a legitimate medical purpose,” said Richard Fields, a D.C.-based lawyer who filed the lawsuit on behalf of the tribe. “If a doctor is engaged in prescribing opioids illegally, that doesn’t relieve the pharmacy of liability.”In 2015, an estimated 845 million milligrams of opioids were distributed in the 14 counties that span Cherokee Nation, according to the Drug Enforcement Agency. That averages out to between 360 and 720 pills per year for every prescription opioid user in the Cherokee Nation, the lawsuit says.By 12th grade, nearly 13 percent of American Indian teens have used OxyContin, according to the American Drug and Alcohol Survey. And 2.6 percent of American Indian students in 12th grade have used heroin, nearly double the rate of the general population. HealthCherokee Nation files lawsuit targeting CVS and other pharmacies in opioid crisis last_img read more

The surgeon general’s dismissal should alarm all doctors

first_img @hakique Like Murthy, most public health physicians work in organizations with few, if any, degrees of separation from their political masters, and these bosses very often have other interests, such as maintaining the support of their political base or appearing to have control over crises. Public health doctors who adopt positions different from their employers do so at their peril. In other words, while pharmaceutical companies use enticements to influence a clinician’s treatment of patients, governments influence a public health doctor’s treatment of the population with an implied threat: “Comply or goodbye.”Some might characterize sacrificing an important job in the public service as naive idealism. You can’t positively influence public health “from the outside,” they might say. At least from the inside, with collaboration and a bit of compromise, you can make incremental change. The slow steps of the tortoise beat the long leaps of the hare, after all. It all sounds wise.These platitudes will be common as long as Murthy’s bold example of standing on principle is rare. But if clinicians, researchers, and public health doctors alike — consistently, unapologetically, and with meticulous reasoning — put the interests of patients above all other interests, including their own, we could see real change. Industry may redirect efforts from marketing to innovation, research agendas may reflect the most important health needs, health system reform may finally address inequities, and patients with mental illness may be treated instead of incarcerated.In the meantime, I hope that Murthy finds comfort in the possibility that his steadfastness will inspire something great in our profession. As Rosa Parks said, “Today’s mighty oak is yesterday’s nut that held its ground.”Hakique Virani, MD, is a specialist physician in public health, preventive medicine, and addiction medicine and assistant clinical professor of medicine at the University of Alberta in Edmonton, Canada. He made the sort of sacrifice that defines our profession — the kind based on the unchanging “patients first” credo. But do doctors, without fail, put patients first?advertisement Related: Democratic senators question Trump over dismissal of surgeon general When Dr. Vivek Murthy’s photo suddenly disappeared from the US surgeon general’s Twitter account, social media was abuzz with people speculating on which proverbial hill his career as surgeon general had ended. Doctors like me wondered which devoted guardian of the public’s health could next face the same fate.The day after being fired, Murthy confirmed on Facebook that he had refused to abandon his commitment to “a healthier and more compassionate America.” Faced with a conflict between personal or career interest and the interests of his patient — the American population — he chose principle over paycheck, like a doctor should.On Wednesday, seven US senators wrote to President Trump asking why Murthy was removed from his position before his term had expired “in light of (the) Administration’s pattern of politically motivated and ethically questionable personnel decisions.” Had it been his stance on gun control? Criminal drug policy? Affordable health care? Or was he dismissed for being the kind of fellow who joined forces with Elmo to debunk the anti-vaccination myths President Trump has given credence to?advertisement By Hakique Virani May 3, 2017 Reprints The public needs to know why Murthy was asked to resign. Doctors do, too. We are often at the intersection of politics, ethics, and health and, when confronted by a conflict of interest, should act like Murthy. Hakique Viranicenter_img Vivek Murthy, surgeon general, is ousted by Trump administration Conflicts are everywhere in medicine, and sometimes the patients’ interest loses out. We know that the pharmaceutical industry uses seductive methods to influence what doctors prescribe. Few would argue about what’s right and wrong in that relationship. But wrong still happens.Structural conflicts of interest in clinical medicine also introduce tension. For instance, most physicians are paid more to see patients with advanced disease than to help patients stay healthy, and invasive treatments pay better than watchful waiting. A difference between the patient’s knowledge and the doctor’s leaves room for supplier-induced-demand. On the other hand, if a physician is salaried rather than paid per service, there may be an incentive to provide less care. The point is, there are unavoidable conflicts between market variables and medical ones, so patients are left to trust their doctor’s commitment to optimizing their health, and conflicts of interest can arise.Medical research has its share of conflict, which goes beyond industry funding of clinical trials. Civil societies depend on universities to be pillars of impartiality, but corporate sponsorship and special-interest funding play a role in what gets studied. So does the pressure on academic physicians to publish. Since novel findings are generally felt to be most publishable, repeating previous studies isn’t carried out as often as it should be. But repeating studies is essential to confirming what’s best for patients.Then there are public health doctors like the surgeon general and his colleagues in the Centers for Disease Control and Prevention — the ones we trust to call the shots in pandemics or on matters of great public health importance. For them, conflicts of interest might be least recognized yet they can have extremely deleterious and far-reaching health effects. Their job is to ensure that the most vital health determinants — like social and physical environments, public policy, and health services — best promote and protect human health. No extraneous interest should supersede that one. Former US Surgeon General Vivek Murthy Charles Dharapak/AP About the Author Reprints First OpinionThe surgeon general’s dismissal should alarm all doctors Related: Tags Donald Trumppublic healthlast_img read more

Lab-made ‘mini organs’ helping doctors treat cystic fibrosis

first_img ‘Stunning’ gap: Canadians with cystic fibrosis outlive Americans by a decade About the Author Reprints Samples of mini organs are shown at the Hubrecht Institute in Utrecht, Netherlands. Aleksandar Furtula/AP “I really felt, physically, like a different person,” van der Heijden said after taking a drug — and getting back in the saddle.This experiment to help people with rare forms of cystic fibrosis in the Netherlands aims to grow mini intestines for every Dutch patient with the disease to figure out, in part, what treatment might work for them. It’s an early application of a technique now being worked on in labs all over the world, as researchers learn to grow organs outside of the body for treatment — and maybe someday for transplants.advertisement New Vertex drugs show dramatic gains for tough-to-treat cystic fibrosis patients UTRECHT, Netherlands — Els van der Heijden, who has cystic fibrosis, was finding it ever harder to breathe as her lungs filled with thick, sticky mucus. Despite taking more than a dozen pills and inhalers a day, the 53-year-old had to stop working and scale back doing the thing she loved best, horseback riding.Doctors saw no sense in trying an expensive new drug because it hasn’t been proven to work in people with the rare type of cystic fibrosis that van der Heijden had.Instead, they scraped a few cells from van der Heijden and used them to grow a mini version of her large intestine in a Petri dish. When van der Heijden’s “mini gut” responded to treatment, doctors knew it would help her too.advertisement So far, doctors have grown mini guts — just the size of a pencil point — for 450 of the Netherlands’ roughly 1,500 cystic fibrosis patients.“The mini guts are small, but they are complete,” said Dr. Hans Clevers of the Hubrecht Institute, who pioneered the technique. Except for muscles and blood vessels, the tiny organs “have everything you would expect to see in a real gut, only on a really small scale.”These so-called organoids mimic features of full-size organs, but don’t function the same way. Although many of the tiny replicas are closer to undeveloped organs found in an embryo than adult ones, they are helping scientists unravel how organs mature and providing clues on how certain diseases might be treated.In Australia, mini kidneys are being grown that could be used to test drugs. Researchers in the U.S. are experimenting with tiny bits of livers that might be used to boost failing organs. At Cambridge University in England, scientists have created hundreds of mini brains to study how neurons form and better understand disorders like autism. During the height of the Zika epidemic last year, mini brains were used to show the virus causes malformed brains in babies.In the Netherlands, the mini guts are used as a stand-in for cystic fibrosis patients to see if those with rare mutations might benefit from a number of pricey drugs, including Orkambi. Made by Vertex Pharmaceuticals, Orkambi costs about 100,000 euros per patient every year in some parts of Europe, and it’s more than double that in the U.S., which approved the drug in 2015. Despite being initially rejected by the Dutch government for being too expensive, negotiations with Vertex were reopened in July. In the LabLab-made ‘mini organs’ helping doctors treat cystic fibrosis center_img Related: Associated Press Making a single mini gut and testing whether the patient would benefit from certain drugs costs a couple of thousand euros. The program is paid for by groups including health insurance companies, patient foundations and the government. The idea is to find a possible treatment for patients, and avoid putting them on expensive drugs that wouldn’t work for them.About 50 to 60 patients across the Netherlands have been treated after drugs were tested on organoids using their cells, said Dr. Kors van der Ent, a cystic fibrosis specialist at the Wilhelmina Children’s Hospital, who leads the research.Clevers made a discovery about a decade ago that got researchers on their way. They found pockets of stem cells, which can turn into many types of other cells, in the gut. They then homed in a growing environment in the lab that spurred these cells to reproduce rapidly and develop.“To our surprise, the stem cells started building a mini version of the gut,” Clevers recalled.Cystic fibrosis is caused by mutations in a single gene that produces a protein called CFTR, responsible for balancing the salt content of cells lining the lungs and other organs.To see if certain drugs might help cystic fibrosis patients, the medicines are given to their custom-made organoids in the lab. If the mini organs puff up, it’s a sign the cells are now correctly balancing salt and water. That means the drugs are working, and could help the patient from whom the mini gut was made.Researchers are also using the mini guts to try another approach they hope will someday work in people — using a gene editing technique to repair the faulty cystic fibrosis gene in the organoid cells.Other experiments are underway in the Netherlands and the U.S. to test whether organoids might help pinpoint treatments for cancers involving lungs, ovaries, and pancreas.While the idea sounds promising, some scientists said there are obstacles to using mini organs to study cancer.Growing a mini cancer tumor, for example, would be far more challenging because scientists have found it difficult to make tumors in the lab that behave like in real life, said Mathew Garnett of the Wellcome Trust Sanger Institute, who has studied cancer in mini organs but is not connected to Clevers’s research.Also, growing the cells and testing them must happen faster for cancer patients who might not have much time to live, he said.Meanwhile, Clevers wants to one day make organs that are not so mini.“My dream would be to be able to custom-make organs,” he said, imagining a future where doctors might have a “freezer full of livers” to choose from when sick patients arrive. Others said while such a vision is theoretically possible, huge hurdles remain.“There are still enormous challenges in tissue engineering with regards to the size of the structure we’re able to grow,” said Jim Wells, a pediatrics professor at the Cincinnati Children’s Hospital Medical Center. He said the mini organs are far smaller than what would be needed to transplant into people and it’s unclear if scientists can make a working, life-sized organ in the lab.There are other limitations to growing miniature organs in a dish, said Madeline Lancaster at Cambridge University.“We can study physical changes and try to generate drugs that could prevent detrimental effects of disease, but we can’t look at the complex interplay between organs and the body,” she said.For patients like van der Heijden, who was diagnosed with cystic fibrosis as a toddler, the research has helped her regain her strength. Vertex agreed to supply her with the drug.“It was like somebody opened the curtains and said, ‘Sunshine, here I am, please come out and play.’” she said. “It’s strange to think this is all linked to some of my cells in a lab.”— Maria Cheng By Associated Press Aug. 23, 2017 Reprints Related: Tags rare diseaseresearchlast_img read more