Novartis has settled a proposed sex discrimination lawsuit. Georgios Kefalas/Keystone/AP [email protected] PharmalotNovartis agrees to settle sex discrimination suit for $8m After less than a year of litigation, Novartis has agreed to pay $8.2 million to settle a proposed collective class action lawsuit filed by more than a dozen female employees who claimed they were denied equal pay and promotional opportunities because of their gender.The settlement, which must still be approved by a federal court in New York, would involve much less than the $110 million that was initially sought by former and present employees at the company’s Alcon Laboratories eye product unit. However, one of the women has not agreed to the settlement. Related: Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. By Ed Silverman Jan. 4, 2016 Reprints About the Author Reprints The original lawsuit was filed last March by just two employees but was later expanded as a proposed collective class action lawsuit and included other past and present employees. The lawsuit charged that women comprised less than 15 percent of senior Alcon management positions, and that this contributed to the alleged discrimination.The women also claimed companywide metrics were used to assess job performance that were “subjective and used to downgrade the performance ratings of female employees,” because final decision-making authority is given to Alcon managers who are primarily male, according to the lawsuit.The one former employee who did not settle, Elyse Dickerson, charges she encountered discrimination after requesting promotions, according to the lawsuit. A former global director of pharmaceuticals, she later filed a complaint with the Equal Employment Opportunity Commission and was fired while on a medical leave, the lawsuit states. She also claims her termination occurred shortly before $750,000 in stock grants would have vested.As we have noted in the past, this was just one of several sex discrimination lawsuits to be filed against big drug makers in recent years. The lawsuits emerged as the pharmaceutical industry shed thousands of jobs, including in ways that may have left the companies vulnerable to charges of discrimination.The same law firm representing the Novartis employees — Sanford Heisler Kimpel — had also filed the earlier case against the drug maker, as well as lawsuits against Merck, Daiichi Sankyo, and Forest Laboratories, which is now part of Allergan. All of the companies denied the charges. The lawsuit also came nearly six years after the drug maker agreed to pay $152.5 million to settle a gender-discrimination class action lawsuit brought by several female sales representatives. In that case, the company reached a deal after a jury awarded $250 million to the sales reps.A Novartis spokeswoman confirmed that a settlement had been reached but declined further comment. A spokeswoman for the lawyers representing the employees and former employees of Novartis’ Alcon also declined to comment.advertisement Ed Silverman Marcia McNutt blazed a trail for women in science — but hit a roadblock with a sexism scandal The lawsuit had gained notice, in part, because the women claimed the company fostered “a boys’ club atmosphere and mentality” that is hostile to women and restricts access to leadership positions, according to court documents.advertisement @Pharmalot Tags lawsuitsNovartis
Tags animalsanxietydrug marketing The drug, a low-dose version of a dog sedative, hit the market last month. It was approved late last year by the Food and Drug Administration to treat dogs with a condition called “noise aversion” that causes symptoms ranging from skittishness to extreme panic and can result in dogs running away or injuring themselves.Zoetis estimates that about a third of dogs are afflicted by noise aversion, which can be triggered by everything from the bangs of celebratory gunfire to the swishing of a running dishwasher.Sileo is the latest offering in a crowded market of remedies. A dog vest branded as Thundershirt has amassed a huge following with the promise to relieve anxiety by simply applying gentle pressure. And a Texas company last week launched a wearable device that promises to deliver “calming frequencies that the dog can hear and feel.”Sileo, which must be prescribed by a vet, is sold as a gel that is absorbed by mouth and costs $30 for several doses. Zoetis pitches it as an option that works faster than existing sedatives and antidepressants, without putting dogs into a stupor. The Finnish drug maker Orion, which developed the drug, tested it on 144 canines on New Year’s Eve and said 75 percent of dogs who took Sileo had lower anxiety than expected during fireworks, compared to 33 percent of dogs who got a placebo. (That’s according to their owners, who were asked to report on their pets’ reactions.)The drug launched so close to July 4th that vets worried their clients wouldn’t learn about it before the skies lit up with fireworks. So they took to social media to spread the word — giving Zoetis a free marketing campaign that speaks to the powerful role social media can play in boosting or sinking the fortunes of a drug.Linda Randall, a veterinarian who owns a pet hospital in Ohio, paid a small fee to Facebook to widely advertise two photos she took to promote the drug. One post urges pet owners to “Call us to see if Sileo is right for your dog.”In another, her border collie, Trace, and her receptionist’s corgi, Chuck, wear bright pink earmuffs. (Trace and Chuck, for the record, are just unpaid actors; neither of them actually suffers from noise aversion.)“If I put a cute picture with it, that might catch people’s eyes,” Randall told STAT in a phone interview over a chorus of barking. “People obviously can’t help their dogs if they don’t know the drug exists.”Some animal clinics and hospitals had dogs don the Sileo-brand bandanas, emblazoned with stars and stripes, for social media photos. There’s new hope for dogs spooked by fireworks. Frank Rumpenhorst/AFP/Getty Images By Rebecca Robbins July 1, 2016 Reprints Zoetis, the big animal drug maker that’s marketing Sileo in the United States, didn’t organize or ask for the PR campaign. But it did supply its sales reps with red-white-and-blue bandanas printed with the drug name to distribute to pet clinics. And it did launch the drug just in time for the Fourth of July. Vets couldn’t resist.advertisement BusinessMeet the furry pitchmen promoting a new drug for dogs scared of fireworks Zoetis wouldn’t say how many prescriptions have been filled since Sileo became available last month.But STAT counted about 40 social media posts from vets and pet clinics promoting the drug. In a Facebook video posted by an Oklahoma pet hospital, a small dog named Olivia cowers under a desk during a thunderstorm, shaking and panting audibly, her tongue stuck way out of her mouth.“I’m going to try a new product called Sileo,” her veterinarian owner says before cutting the feed.Twenty-five minutes later, the camera comes back on: Olivia is still under the desk but only trembling slightly. And her tongue is securely back in her mouth. They’ve sold out to Big Pharma to hawk a new drug — and they didn’t even get paid for it, not in biscuits or in bones.The furry faces of pitchdogs are flooding Facebook and Twitter as dozens of veterinarians and pet hospitals seek to raise awareness of Sileo, the first drug approved to calm canines who are afraid of fireworks and thunderstorms.“Do not fear, Sileo is here!” Aston, a gray-and-white dog with a remarkable grasp of English, is quoted as saying (or perhaps, barking) in one post.advertisement
APStock Why is it so damn hard to get a paper retracted? By Ivan Oransky and Adam Marcus Nov. 4, 2016 Reprints Why our peer review system is a toothless watchdog But what Fiske is talking about is actually much more sweeping. She writes that “constructive critics have a role” in policing the integrity of science. (Ironically, Fiske felt compelled to reshape her essay after a draft leaked, in which she wrote that some scientific critics engaged in “methodological terrorism,” led to an “online firestorm” of complaints from readers. That’s rich.) But then she adds an astonishing caveat: that such critiques be subject to “editorial oversight and peer review for tone, substance, and legitimacy.”advertisement Related: A “culture of shaming” is now permeating psychology, and science in general, according to a former president of the Association for Psychological Science.In an essay in the society’s house organ, the Observer, Princeton psychologist Susan Fiske claims that the “new media” “can encourage a certain amount of uncurated, unfiltered denigration. In the most extreme examples, individuals are finding their research programs, their careers, and their personal integrity under attack.”And in an echo of the misguided term “research parasites,” which appeared in an editorial by the New England Journal of Medicine, Fiske also goes after “self-appointed data police” who lob “critiques of such personal ferocity and relentless frequency that they resemble a denial-of-service attack that crashes a website by sheer volume of traffic.”advertisement In other words, it’s OK to criticize scientists, but only if the scientific establishment has a chance to approve the criticism first. That’s a bit like asking students to grade their own papers or letting restaurant owners edit reviews of their food before they run in the newspaper.Do critics occasionally go overboard? Of course they do. We’re not unsympathetic to the idea that bullying and nasty personal attacks can derail conversations, create unneeded distractions, and even lead to collateral damage. Some of the people we’ve written about on Retraction Watch have tried to discredit us using the same tactics Fiske describes, including blast emails to funders and employers full of fact-free innuendo and wild speculation. (That sort of thing only reinforces the idea that we’re onto something, so feel free to continue, if you’re reading this.)But let’s remember why we’re seeing this recent surge in concern about the integrity of research: The scientific establishment writ large has demonstrated little interest in making fixes to the literature. Don’t believe us? Ask David Allison, a professor at the University of Alabama, Birmingham, whose effort, along with colleagues, to get journals to correct blatant errors they discovered in published studies was met with almost uniform refusal — or worse, silent treatment. Or ask us to see the countless emails we’re forwarded to journal editors — some by very prominent researchers — who’ve hit a brick wall when they’ve tried to have flawed studies corrected. Related: In short, Fiske’s argument for more polite and moderated critiques, while reasonable on the surface, misses the bigger picture. Unethical behavior and irreproducible results, while not necessarily rampant, are undeniable problems for science in general and psychology in particular. For an example of unethical behavior, see Diederik Stapel. For an example of an attempt to bolster reproducibility, see the work of Brian Nosek and his colleagues.What’s more, Fiske also conveniently ignores the fact that many critics choose anonymity not because they want to throw Molotov cocktails but because they are afraid of retribution from their colleagues and superiors.But sites like PubPeer, which provide a platform for anonymous concerns, are immeasurably useful, with surprisingly little collateral harm, despite evidence-free claims by some to the contrary. Thanks to moderation, PubPeer commenters sling little, if any, mud, yet their posts have led to many retractions of problematic papers.“Fiske’s suggestion of reviewing all discussion has been tried and it failed utterly,” Brandon Stell, one of PubPeer’s founders, told STAT. “PubPeer was created specifically to bypass the suffocating and restricted channels of ‘correspondence to the editors’ and journal commenting. The tens of thousands of useful comments that users have posted on PubPeer were previously suppressed by that system, yet facilitated by an open framework encouraging factual discussion. We’re not going back.”The bottom line here is that correcting the scientific literature is critically important — but well-nigh impossible using conventional methods. We’d be far more sympathetic to the arguments of the tone police if Fiske and others offered real solutions to these issues instead of verbal equivalent of aloe vera. Having all criticism go through peer review might make the hurt feelings go away — but it could well kill the patient in the process.“The lesson for the future is therefore simple,” Stell said. “If you don’t wish your work to be discussed, don’t publish it.” Tags academic publishingpeer review The WatchdogsToo much public shaming is bad, but that’s not the real problem in science When it comes to Twitter, it’s a subject that has gotten wide play in recent months. The platform lends itself to anonymous trolling and lacks a solid system for reporting abuse — something many users, not just scientists, would like to see remedied.
When Rachel Lefebvre agreed in September to speak with me for a story about her quest to find a clinical trial to treat her stage 4 colon cancer, she had one stipulation: There could be no mention of her prognosis, lest her sons, Pierro, 12, and Sebastien, 10, discover how precarious her situation was. Her cancer had “come back with a vengeance,” she said. She was losing energy and her liver was starting to function poorly as a result of her tumors and treatments.When STAT published her story in early October, Lefebvre had two final options. Plan A was in Denver, where researchers were about to test a combination of immunotherapy drugs — the new and promising class of cancer therapies that turn the body’s immune system against tumors. If she could not clear the waiting list for the Denver trial, she hoped to secure the drugs on her own and follow Denver’s protocol at home.advertisement Tags cancerend of liferesearch She’d done everything by the book. She had begun exploring trials soon after being diagnosed in 2013. She’d switched oncologists to find one who was willing to consider experimental treatments. She was still healthy enough to qualify for a spot in a trial, and she’d found a promising option.Yet she knew she still faced long odds.After her story was published along with a video of her and her family, Lefebvre wrote in an email: “I know my kids don’t get how hard things have been for me and how hard I have been ‘fighting’ with all I have. I want them to know in the end that I have fought tooth and nail for them, that my fight has been a testament of my love for them. … They will have this video to remind them and that means a lot to me.” Searching for the right clinical trialVolume 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/2016/12/28/immunotherapy-fight-cancer/?jwsource=clCopied EmbedCopiedLive00:0004:2104:21 Rachel Lefebvre had stage 4 colon cancer and was searching for an immunotherapy treatment that would combat her tumors. Matthew Orr/STAT Her wider legacy would be for strangers — those with cancer who, upon reading her story, might better understand what they face if they exhaust conventional medical options. One cancer researcher thanked her personally: “It is a gift you have given many others to know that this problem is pervasive,” he wrote.Lefebvre’s story also circulated among leaders of the research and funding community. Work was underway to improve ClinicalTrials.gov, and according to one person involved in that effort, Lefebvre’s story helped accelerate it.Should ClinicalTrials.gov be made more helpful to patients, it will, alas, serve a generation of people who will never know the woman who helped spur at least some of that change.In the weeks following the publication of Lefebvre’s story, both her body and the cancer trial system conspired against her. Researchers unexpectedly shut down the trial she had hoped to join in Denver, her doctors grew uncomfortable with helping her try an untested drug combination at home, and no other good experimental options emerged.In her final blog post last month, she wrote that she was seeking palliative care. She died early this month. She was 43. She leaves behind her husband, Fred, their sons, and a legion of cancer survivors who may face better odds as a result of the battle she waged. HealthA fight against cancer became a testament of love Rachel Lefebvre with her husband, Fred, and their sons outside their Florida home in September 2016. Matthew Orr/STAT By Bob Tedeschi Dec. 28, 2016 Reprints Unlike many other patients, Lefebvre had a Ph.D. and an ability to navigate the Byzantine world of medical journals. She also had an oncologist with deep expertise in experimental treatments. But even then, Lefebvre struggled to find good options among the roughly 52,000 trials listed on the government’s website ClinicalTrials.gov, because the system is often designed with research, not patients, in mind.Further complicating matters, many immunotherapy researchers want only those patients who’ve not yet tried the new drugs, leaving people like Lefebvre to face the decision of a lifetime — namely, which single potentially life-saving therapy to bet on.advertisement
Pharmalittle: Shire rejects latest Takeda offer; Greek parliament ends Novartis bribery probe What is it? About the Author Reprints Alex Hogan/STAT Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. @Pharmalot Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. 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. GET STARTED Hello, everyone, and how are you today? A warm and shiny sun is enveloping the Pharmalot campus this morning, which is a welcome relief given the recent temperatures. We were already warming up, however, with a few cups of delicious stimulation. Our choice today is blueberry, for those interested in such things. Please do join us. After all, firing up the neurons can be a worthwhile exercise. Meanwhile, here is the latest menu of tidbits. We hope you have a grand day or, at least, survive. And if you do, by all means, keep in touch …Shire (SHPG) has rejected a third offer from Takeda Pharmaceutical (TKPYY), arguing the latest bid from the Japanese drug maker, which was $60 billion, continues to significantly undervalue the company and its growth prospects and pipeline. Takeda has an April 25 deadline to strike a deal. Takeda has been ramping up its takeover ambitions as the company seeks growth overseas amid patent expirations and a shrinking domestic population. Takeda would gain new assets in gastrointestinal diseases and nervous-system ailments, and key treatments that are in the late stages of testing, Bloomberg News points out. By Ed Silverman April 19, 2018 Reprints Log In | Learn More What’s included? Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED Pharmalot [email protected] Ed Silverman Tags Congressdrug pricingFDAopioidspharmaceuticalspharmalittleSTAT+Trump
What is it? By Ed Silverman Oct. 11, 2018 Reprints Pfizer pays $700,000 to settle charges over misleading copay coupons In recent years, copay cards and coupons have become wildly popular with consumers who believe they can save significant sums at the pharmacy counter. But in a twist, Pfizer (PFE) has agreed to pay $700,000 to settle charges of misleading people who actually had to spend much more than expected.As part of its program, consumers were told they would “pay no more than” a small amount of money — from $15 to $25 — for certain medicines, but were actually required to pay more because of limits on total savings that were not prominently disclosed. In one instance, a woman had to pay $144.62, according to New York Attorney General Barbara Underwood. Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Log In | Learn More Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Ruby Wallau for STAT What’s included? 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 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. Ed Silverman [email protected] Tags drug pricespharmaceuticalsSTAT+ About the Author Reprints Pharmalot
[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. By Ed Silverman Sept. 4, 2019 Reprints Alex Hogan/STAT Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. 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. Ed Silverman About the Author Reprints Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Rise and shine, everyone, another busy day is on the way. And the Pharmalot campus is no exception. Our shortest person has left for the local schoolhouse, the other short one is gearing up for a new round of gainful employment, and our official mascot is breathing heavily nearby. All of which means we are, more or less, left to our own devices. Scary thought, yes? Well, take heart. We have faithfully assembled the latest menu of tidbits for you to peruse. Hope your day is smashing and, as always, do keep in touch. …A U.S. judge rejected efforts by major drug makers, pharmacies, and distributors to dismiss claims that they caused the nation’s opioid crisis, clearing the way for a scheduled landmark trial even as he pushes for a nationwide settlement, Reuters reports. U.S. District Judge Dan Polster, who oversees roughly 2,000 opioid lawsuits by states, counties, and cities, ruled the plaintiffs can try to prove that deceptive marketing of the painkillers caused a harmful, massive increase in supply that pharmacies and distributors did not do enough to stop. Pharmalot GET STARTED What’s included? Pharmalittle: U.S. judge rules drug makers must face opioid trial; Purdue threatens bankruptcy @Pharmalot Log In | Learn More What is it? Tags drug pricinglegalopioidspharmaceuticalspharmalittleSTAT+
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 Nicholas Florko Oct. 29, 2019 Reprints WASHINGTON — Is seeking a cure for Alzheimer’s disease hopeless? Is Biogen’s recent decision to repurpose a failed Alzheimer’s trial an elaborate parlor trick? And what about Pfizer’s decision to walk away entirely from neuroscience entirely?The unanswered questions in the field of Alzheimer’s research can make the average observer’s head spin. Health Nicholas Florko Unlock this article — and get additional analysis of the technologies disrupting health care — by subscribing to STAT+. First 30 days free. GET STARTED The experts on stage at the Milken Institute’s Future of Health Summit. Milken Institute 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. Washington Correspondent Nicholas Florko reports on the the intersection of politics and health policy. He is the author the newsletter “D.C. Diagnosis.” @NicholasFlorko Taking stock of Alzheimer’s research: Experts offer takes on Biogen, the NIH, and the amyloid hypothesis GET STARTED Log In | Learn More [email protected] About the Author Reprints What’s included? Tags dementiadrug developmentgovernment agenciesneuroscienceresearchSTAT+