Month: June 2021

J&J loses another lawsuit tying Risperdal to male breasts

by admin
first_img [email protected] “This is the worst of all worlds for J&J,” said Thomas Kline, an attorney who represented the Wisconsin man in the latest trial. “The company has now lost four failure-to-warn cases in a row. But the first three losses involved very significant disfigurement, and this latest case involved less disfigurement. These findings don’t bode well for the company.”The health care giant faces approximately 8,000 such lawsuits filed in state and federal courts around the country, but whether this string of losses will prompt settlement negotiations is unclear.On the one hand, the negative publicity surrounding the side effect attributed to Risperdal is clearly a liability. But J&J also follows a typical pharmaceutical playbook of fighting product-liability lawsuits, at least until a clear pattern is established. One expert says that it is probably too soon for the company to pursue a far-reaching settlement.“J&J has not compiled a good track record … so far in the Risperdal trials, but relatively few cases have been tried to date,” said Carl Tobias, a professor at the University of Richmond law school, who tracks pharmaceutical industry litigation. “My sense is that J&J may be willing to have several more trials to see whether it can win some before it seriously considers the prospect of settling a number of cases.” Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. About the Author Reprints Once again, Johnson & Johnson has lost litigation trial in which a young man successfully claimed the company failed to warn that its Risperdal antipsychotic could cause him to grow breasts. A Pennsylvania state court jury late last week ordered the company to pay $500,000 to a Wisconsin man who developed breasts when he was 12 years old while taking the drug.The health care giant has now lost all four trials in which its drug caused gynecomastia, which is typically caused by an imbalance of estrogen and testosterone. In three of the four verdicts, compensatory damages were awarded. In one trial, a jury found J&J failed to warn of the risks, but did not award punitive damages because a direct link between breast growth and Risperdal was not established. Tags Johnson & JohnsonRisperdalside effects PharmalotJ&J loses another lawsuit tying Risperdal to male breasts Ed Silverman @Pharmalot Johnson & Johnson has lost a lawsuit in which a male plaintiff sued the firm after developing breasts while on the drug Risperdal. Mel Evans/AP Drug maker challenges tribal court’s right to hear lawsuit By Ed Silverman Dec. 14, 2015 Reprints The cases have drawn attention for a few reasons. For one, the trials have served as a reminder that J&J paid $2.2 billion nearly three years ago to resolve criminal and civil allegations of illegally marketing Risperdal to children and the elderly. Along with a manufacturing scandal involving recalls of countless over-the-counter medicines, the Risperdal episode sullied the company’s well-honed reputation.advertisement In addition, former Food and Drug Administration commissioner David Kessler served as a paid expert witness in the first trial. He testified that J&J knew about the risks associated with Risperdal, but failed to disclose the data showing the extent to which youngsters may develop gynecomastia. In a report prepared for a 2012 case that was settled, Kessler wrote J&J had violated the law (you can read the report here, here, here and here).When asked whether J&J plans to appeal the latest verdict, a spokeswoman wrote us that the company is considering its options.advertisement Related:last_img

New screening tool for IVF embryos leads to birth of healthy children

by admin
first_img IVF embryos in a dish. Sang Tan/AP New research may potentially improve the chances of success for some women and couples looking to get pregnant through in vitro fertilization.IVF has been around for nearly four decades, but the procedure still has a relatively low success rate due, in large part, to genetic and chromosomal mutations in embryos that can be difficult to detect. While various methods have been developed to identify such mutations for selecting those with the highest chances of resulting in a successful pregnancy, their accuracy remains challenging.In a study published Monday in the Proceedings of the National Academy of Sciences, researchers from the United States and China describe a method that they said for the first time combines the latest in gene sequencing technologies with other genomic-based strategies to identify those mutations, leading to better detection and allowing for the improved selection of human embryos for IVF.advertisement Gene studies shed light on women’s reproductive health One reason for the relatively low IVF success rate — from as high as about 40 percent for women under the age of 35 to as low as about 12 percent for women over the age of 40 — is what is known as a chromosomal aneuploidy, when a cell does not have the normal count of 46 chromosomes. Another factor are alterations in a single gene, or when a gene is missing.Separate genetic technologies can detect aneuploidies or single-point mutations, but they had not been able to detect both abnormalities at the same time. The new method — dubbed MARSALA, short for mutated allele revealed by sequencing with aneuploidy and linkage analyses — combines both into one simple approach. The researchers tested MARSALA on two couples undergoing IVF. Both cases involved parents in their early 30s — one in which the father harbored a genetic mutation that caused multiple bony spurs and lumps to grow in his body; another in which the mother carried a recessive mutation on one of her X chromosomes that she had already passed on to one son, who now suffers from hair, sweat, and skin abnormalities. By using MARSALA, the researchers selected mutation-free embryos for the two couples, each resulting in the birth of a healthy girl free of the parents’ genetic problems.The scientists noted that the method is limited to parents who already have known genetic disorders, and cannot be used for the general population. But in those cases, they write, “MARSALA has improved the precision” of diagnostic and screening techniques for IVF embryos.Not all reproductive medicine doctors agree. Dr. Michael Alper, medical director of Boston IVF, said MARSALA could have a place in the clinic for some couples. But Dr. Francesco Fiorentino, president and CEO of Genoma Molecular Genetics Laboratory in Rome, said the method mostly serves to “simplify the laboratory workflow” without offering much improvement at the patient level.Fiorentino noted that MARSALA still can’t pick up on a phenomenon called mosaicism, in which a person’s cells have a different genetic makeup — a common problem in IVF-derived embryos. This, he said, undermines “the reliability of the results.” Teen birth rates plunge to record low Related:center_img In the LabNew screening tool for IVF embryos leads to birth of healthy children Related: Two healthy babies were born after the method was used to select embryos.Dr. Jason Franasiak, an infertility specialist at the Rutgers Robert Wood Johnson Medical School, described the technique as a “safe, accurate, and cost-efficient means for performing comprehensive chromosome screening, and single-gene defect diagnosis.” Franasiak was not involved in the study.advertisement By Tony Fong Dec. 28, 2015 Reprints Tags geneticsIVFreproductive medicinelast_img

The science behind Janet Jackson’s pregnancy at 49

by admin
first_img The average new mom is older than ever Leave this field empty if you're human: Once the egg’s DNA has accumulated damage it can’t repair, then its division as an embryo goes haywire, with chromosomes sticking together when they should come apart. “The resulting embryo may end up with too many or too few chromosomes,” said Dr. Kutluk Oktay, a fertility doctor and researcher at the New York Medical College. “The majority of those end up in miscarriages.”So older would-be mothers often use eggs donated by younger, more fertile women. For younger women seeking pregnancy, donor eggs might only be discussed after they’ve tried other kinds of fertility treatments, but for those over 45, “that’s kind of where they start,” said Alicia Abdella, an infertility social worker at Massachusetts General Hospital.3. It’s the age of the egg rather than the age of the wombAccording to the Society for Assisted Reproductive Technology, “the single most important factor in predicting the success of [in vitro fertilization embryo transfer] is the age of the female partner.” Eric Boodman By Eric Boodman May 6, 2016 Reprints 1. Pregnancies after 50 are rare, but they do happenThe number of births to women of this age has jumped significantly: 743 women aged 50-54 gave birth in 2014, up from 255 in that age group a dozen years earlier, according to data from the Centers for Disease Control and Prevention. But it’s still exceptionally rare: only 1 in 10,000 births in the US are to women Jackson’s age. There’s an overall trend toward older motherhood in the US. A growing share of these are first-time births, reflecting the fact that women, like Jackson, are waiting longer to start families.advertisement HealthThe science behind Janet Jackson’s pregnancy at 49 Where have all the triplets (and quadruplets, and quintuplets) gone? The organization has said that the likelihood of pregnancy using young donor eggs in an older mother are comparable to those of young women using their own eggs.Still, advancing age may make gestational surrogates an attractive alternative, since older women do face increased health risks with pregnancy, including gestational diabetes, high blood pressure, and premature birth. Cost can be one of the biggest barriers to gestational surrogacy, but for people for whom money is no object, it is an option. Newsletters Sign up for Morning Rounds Your daily dose of news in health and medicine. Tags celebritiesfertilityJanet Jackson Among celebs, Jackson is probably the most noteworthy post-50 mom, though many stars — including Geena Davis, Sophie B. Hawkins, and Halle Berry — have had children in their late 40s. But Indian villager Rajo Devi wins the prize: She was 70 when she had her first child. As Jackson herself has put it, “Dammmn, baby.”2. It’s probably a donated egg“It’s exceptionally rare for patients to get pregnant naturally at 50 or over 45. They make history,” said Dr. David Keefe, an obstetrician-gynecologist and fertility researcher at New York University.In part that’s because around age 50, many women are entering menopause, after which egg harvesting isn’t possible.And as eggs age they also accumulate more genetic glitches. The mechanism is not completely understood, but it may be because eggs have shorter telomeres, the protective caps on the ends of our chromosomes.center_img Please enter a valid email address. @ericboodman Her tour might be called Unstoppable, but Janet Jackson has decided to put it on hold. That’s because the pop star is pregnant just weeks before her 50th birthday, according to the celebrity news site Entertainment Tonight.That will make hers a rare quinquagenarian pregnancy. But she’s one of a growing number of older new mothers in the United States — a trend that’s bolstered by changing societal norms and new advances in fertility treatments.Here are three things to know about pregnancy post-50.advertisement Related: Privacy Policy Janet Jackson recently announced she is pregnant at age 49. Francois Nel/Getty Images Related: [email protected] General Assignment Reporter Eric focuses on narrative features, exploring the startling ways that science and medicine affect people's lives. About the Author Reprintslast_img

When DNA and medical tests disagree about breast cancer risk, which to believe?

by admin
first_img Self-exams aren’t helpful, and other surprising facts about breast cancer In cancer, it’s back to the future as old treatments make cutting-edge ones more effective A human breast tumor that was transplanted into a mouse for study. National Cancer Institute/Univ. of Chicago Comprehensive Cancer Center But some oncologists not involved in the study were more cautious.“I don’t think they accomplished what they meant to,” said Dr. Harold Burstein, a breast cancer physician at Dana-Farber Cancer Institute. He noted that there was, indeed, “a small advantage from chemotherapy” even when the genetic test suggested low risk and therefore no need for chemo.Women who had chemo despite genetic results saying they were at low risk had a 1.9 percentage point greater chance of surviving to five years without the cancer showing up in their bones, brain, liver, or other metastatic site. They also had a 1.5 percentage point greater chance of being alive, compared to women who put their faith in the genetic test.“A difference of 1.5 percentage points, if real, might mean more to one patient than to another,” oncologists Dr. Clifford Hudis and Dr. Maura Dickler of Memorial Sloan Kettering Cancer Center wrote in an editorial accompanying the study in the New England Journal of Medicine. A benefit of “only” 1.5 percentage points is something “that clinicians and patients might find meaningful.” Sharon Begley Related: Breast cancer study shows benefit to extended treatment with aromatase inhibitors By Sharon Begley Aug. 24, 2016 Reprints Senior Writer, Science and Discovery (1956-2021) Sharon covered science and discovery. About the Author Reprints If widely adopted, the results could spare 35,000 women with early-stage breast cancer in the US each year the ordeal, toxicity, and expense of chemotherapy, hormone-based therapy such as tamoxifen, or other drugs after they undergo the first-line treatments of surgery and, usually, radiation.advertisement The test’s manufacturer, Amsterdam-based Agendia, and sponsors of the study described it as “landmark” research that “could change clinical practice.” It’s a dilemma more and more cancer patients will face as genetic testing becomes part of everyday health care: When a DNA test indicates low risk of a tumor spreading, but traditional tests show a high risk, which do you believe?According to a large European study of 6,693 patients published on Wednesday, many women with early breast cancer can safely believe the genetic test.Patients who skipped chemotherapy when a genetic test showed low risk of the cancer advancing but a traditional test suggested high risk were almost as likely to survive five years without the cancer recurring as those who had chemo. (The traditional tests look for cancer cells in lymph nodes and fast-dividing cells, for instance, and include demographic facts of life, such as being over 50.)advertisement Another concern is how long the patients in the study, who had stage 1 or 2 breast cancer, were followed: five years. The study therefore can’t say whether skipping chemo based on a genetic test makes it more likely that early breast cancer will spread six, 10, 15, or more years later. (The researchers are continuing to study the women in order to answer that.)The main results of the study, called MINDACT, were presented in April at the annual meeting of the American Association for Cancer Research. The NEJM paper goes into more detail.In actual numbers, 94.8 percent of women with genetic results indicating a low risk of advanced disease but “clinical” results indicating a high risk made it to five years without their cancer advancing if they skipped chemo. Among patients with similar test results who opted for drug treatments, 96.7 percent did. Looked at another way, 5.2 percent of the no-chemo group saw their cancer advance within five years, while 3.3 percent of women who had chemo did.The study, led by Dr. Martine Piccart of the Jules Bordet Institute in Brussels and conducted in nine European countries, is the latest to assess how well genetics can guide cancer treatment, not only to identify a treatment but also to say when treatment (especially chemo) can safely be skipped.A 2015 study, also in breast cancer, reported that a test of 21 genes, called Oncotype DX, could identify which patients have a 99 percent chance of surviving without metastatic tumors appearing in the next five years even though they did not have chemotherapy. The genetic test used in MINDACT, called MammaPrint, analyzes 70 genes associated with a breast tumor’s chance of metastasizing. It was approved for early breast cancer by the Food and Drug Administration in 2007 and has a list price of $4,200, which Medicare and some private insurance plans cover.The study was funded by the nonprofit European Organisation for Research and Treatment of Cancer; six of the 34 authors have financial or other ties to Agendia. Study coauthor Laura van’t Veer of the University of California, San Francisco, is the company’s cofounder, its chief research officer, and inventor of MammaPrint.She defended the study’s focus on five-year results because if breast cancer is going to metastasize it is most likely to do so in the first two to five years after a woman’s initial treatment. As to whether the 1.5-percentage-point lower chance of avoiding metastasis is enough to make women ignore the encouraging genetic results and choose drug therapy, “the small benefit [of that therapy] is something to discuss between a woman and her physician,” said van’t Veer. “Everyone has to reach their own judgment.” HealthWhen DNA and medical tests disagree about breast cancer risk, which to believe? @sxbegle Related: Related: [email protected] Tags breast cancercancergeneticslast_img

More doctors need to vote and get politically involved

by admin
first_img Doctors don’t vote — at least not enough.We’re less likely to vote than lawyers, other professionals, farmers, and the general population. In some recent elections, less than one-third of doctors voted.It’s not clear why. Some doctors may simply be too busy and, without protected time from work, can’t get to the voting booth. Some may feel that caring for patients fulfills their sense of social purpose, making other forms of civic participation, like voting, seem less important. Indeed, physicians seem to volunteer and donate to candidates at lower rates than other professionals, too.advertisement Related: Why don’t medical schools teach us to confront racism and police brutality? One positive sign is that more physicians are now running for office. Between 1960 and 2004, only 25 members of Congress were physicians, accounting for just 1 percent of elected representatives. Since 2005, however, 27 physicians have been elected to Congress, with 18 serving in the 114th Congress alone. In some ways, this represents a return to our roots: More than 10 percent of the signers of the Declaration of Independence were physicians, and during the first 100 years of Congress, almost 5 percent of its members were.But an important disconnect should be highlighted: Physicians as a group are growing more liberal while those representing the profession in Congress are almost exclusively conservative.advertisement Finally, physicians provide an increasingly rare link in an increasingly unequal society. We not only bear witness to the struggles of the most disadvantaged members of the communities we serve, but we’re also in a position to do something about them. For doctors — unlike for many policymakers — it’s more than just theoretical when a homeless shelter is closed or an insurance benefit cancelled. It’s not an abstract concept when a young mother can’t take a day off work to see me for her diabetes, or an elderly man can’t afford the medications I prescribe. Our work forces us to confront these issues in a visceral, not a cerebral, way.Doctors are leaders of an evolving health system now equal parts medicine, economics, and politics. But we’re not as involved as we need to be. Our responsibilities to patients, policy, and the public extend beyond clinics and hospitals. We can’t all volunteer, donate, advocate, or run for office. But at the very least, let’s vote.Dhruv Khullar, MD, is a resident physician at Massachusetts General Hospital and Harvard Medical School. About the Author Reprints If my health as an anesthesiologist has to be painstakingly vetted, so should a president’s First OpinionMore doctors need to vote and get politically involved Political donations made by doctors to Republicans have declined substantially over the past 20 years. In 1996, nearly 75 percent of physician campaign contributions went to Republicans; in 2012, less than half did. A key driver in this shift is the increase in women and minority physicians, who tend to support Democrats. Medical students, too, are now far more likely to identify as liberal than are other young adults.Contrast this with the physicians currently serving in Congress: All are men, most are white, and all but three are Republican. This is not problematic in itself, but it does suggest that physician representatives have very different views than the physician electorate — and that those purporting to speak for the profession actually may not be.Adding an important voiceRegardless of party affiliation, more politically active physicians could add an important voice to our political and social discussions. Health care accounts for the largest share of the economy, at more than 17 percent of the gross domestic product. In the 2012 presidential election, health care was the second most important issue to voters. This year, prescription drug pricing emerged as a major public concern, and both Republican and Democratic voters favor government intervention to help reduce prices.Americans, increasingly skeptical of and disenchanted with politics, still seem to trust doctors. A recent poll found that 90 percent of Americans had a “great deal” or “fair amount” of respect for doctors, as compared to 48 percent for business executives, 45 percent for lawyers, and 20 percent for politicians. They also identify doctors as the professionals most likely to make the right decisions for the health system.Political participation could also help doctors preserve autonomy in a profession increasingly encroached upon by external factors like guidelines, regulations, metrics, and payment changes. As medicine continues to evolve, we must do a better job helping to navigate and drive these changes. If we abdicate our role in the political process, we do so at our own peril. Joe Raedle/Getty Images @DhruvKhullar By Dhruv Khullar Oct. 3, 2016 Reprints Dhruv Khullar Related: Tags doctorspoliticsvotinglast_img

One state takes a novel approach to opioid addiction: access to treatment for all inmates

by admin
first_img Andrew Joseph By Andrew Joseph Aug. 3, 2017 Reprints Please enter a valid email address. CRANSTON, R.I. — As the country reckons with an unfolding opioid crisis, and officials from both parties talk about improving access to care, jails and prisons remain treatment deserts. Few facilities provide any addiction treatment, and when prisoners are released, they return to the same environments — and the same triggers — that fostered their addiction in the first place.Here, at its campus of squat brick buildings, the Rhode Island Department of Corrections is trying something different. Over the past year, it has expanded its so-called medication-assisted treatment program, becoming the first state system to offer such a broad range of therapies — including all three drugs approved to treat addiction — to its entire prison population.For supporters, there’s a simple argument behind the initiative: Medication-assisted treatment, or MAT, is considered the most effective therapy for opioid addiction, and so providing it is the right thing to do from a public health perspective. And if it can help reduce recidivism, it’s the right thing to do from a criminal justice perspective.advertisement “It is standard of care in the community, so I think eventually it will become standard of care in correctional facilities,” said Dr. Jennifer Clarke, the medical programs director for the corrections department. But researchers studying Rhode Island inmates have found that prisoners who take methadone before their release are more likely to continue their treatment. If they do that, the hope goes, they will be less likely to overdose or to commit crimes.“We cannot afford to keep getting all these people with opioid use disorders coming into these publicly funded institutions and not get treated, because it only fans the flames of this crisis as they are released,” said Dr. Josiah Rich, a Brown University researcher who is assessing Rhode Island’s MAT program.Other states have started to look to Rhode Island to learn from its MAT program, and the Obama administration highlighted it as a national model.This week, the White House’s commission on combating the national opioid epidemic released an interim report recommending that the Justice Department increase MAT in prisons. The panel noted that multiple studies have shown that inmates who received treatment had lower recidivism rates than those who did not.Dr. Jennifer Clarke, the medical programs director for the corrections department in Rhode Island, says she believes medication-assisted treatment will eventually become the standard of care in correctional facilities. Aram Boghosian for STATBut there are challenges to replicating Rhode Island’s system, and the corrections system here enjoys some advantages.It had political support for the effort, with the state government approving $2 million annually for MAT in prisons. And the corrections system is compact: Rhode Island does not have county jails. All inmates are brought to one center here, and the state’s prisons are all on the same campus.“If we start someone on MAT in jail, we’re not worried about them getting sent upstate to prison,” Clarke said. “They’ll go across the street, and they continue or we can take them off slowly.” “We cannot afford to keep getting all these people with opioid use disorders coming into these publicly funded institutions and not get treated, because it only fans the flames of this crisis as they are released.” Related: Newsletters Sign up for Daily Recap A roundup of STAT's top stories of the day. Clarke has worked in the corrections department for 20 years, and she’s been advocating to expand MAT for just as long. But until last year, only people already on methadone when they were incarcerated could get a week’s worth of treatment (except for pregnant women, who have always remained on treatment).Now, inmates are screened when they arrive, and those with opioid use disorders are given the option of treatment. Inmates can take methadone or buprenorphine for up to a year, and restart treatment before they are released. Vivitrol is given a month or two before release. The program also includes counseling.The treatment is provided by CODAC Behavioral Healthcare, a nonprofit with clinics around the state, and the idea is that inmates will transition to one of those clinics when they are released to continue their care.Some law enforcement authorities have embraced Vivitrol because it is not an opioid, a message touted by its manufacturer, Alkermes, as it has lobbied lawmakers and drug courts. Other experts have questioned the data supporting Vivitrol and noted that there is more rigorous evidence supporting the use of methadone and buprenorphine. (Data from the first study to compare Vivitrol and Suboxone are expected this year.)But for Clarke, what matters most is that inmates find a treatment they will stick with. Giving prisoners Vivitrol, for example, is useless if they don’t show up for another dose when released.“Vivitrol is a great medication, for the right patient,” she said. “Really, the best treatment is the treatment that the patient will engage in.”Experts said they see hints that MAT is becoming more accepted.“There are all these ways to bash the treatment, but none of that is based on an argument about the effectiveness of the data,” said Dr. Joshua D. Lee, an associate professor at New York University School of Medicine. “In general, attitudes are certainly shifting in favor of finding solutions.” Dr. Josiah Rich, Brown University @DrewQJoseph About the Author Reprints Leave this field empty if you're human: Still, there is always concern that buprenorphine and methadone will be diverted and used illicitly. While the medications typically cannot give users a heroin-like high, they can generate a buzz. Some illicit use may also stem from inmates seeking out the medications to assuage their withdrawal symptoms, experts say, meaning the treatments are, in a way, being used for their approved purpose.“So it’s hard, right?” said Dr. Warren Ferguson, an expert in criminal justice and health at the University of Massachusetts Medical School, who is studying MAT in New England jails and prisons. “If the primary mission of a correctional facility is safety and security, and health care is secondary to that, if you look at it through that lens, you can understand why correctional facilities are enthusiastic about antagonists” like Vivitrol.But, Ferguson said, evidence shows that treatment with methadone and buprenorphine improves outcomes in communities. Now, researchers are trying to replicate that in jails and prisons.“What are some of the facilitators and barriers to establishing those programs?” Ferguson said. “What are some of the adaptations that need to be made for that to be successful?” MAT consists of three therapies. Two, methadone and buprenorphine (often referred to as Suboxone), are opioids that help stave off withdrawal symptoms and reduce cravings, while the third, Vivitrol, is an “antagonist,” meaning it blocks people from getting high if they use drugs.John Young, a 27-year-old inmate here, said his daily dose of methadone has saved him from the worst of withdrawal’s effects. He began treatment four months ago at the start of a six-month sentence for a probation violation tied to a drug-related charge, and it’s provided him with a level of stability.advertisement Young said he plans to maintain his methadone regimen after he’s released.“It’ll keep me safe — you don’t have to take the risk of getting out there and trying to find heroin or using needles,” he said. Without methadone, “as soon as I got out, I’d probably want to get high.”“I want a good job, I want to succeed, I want to be better for my family,” he added. “I want actual things to be proud of.”An estimated half to two-thirds of all prisoners have some form of substance abuse disorder. Doctors say there’s a public misconception that incarceration, particularly years-long incarceration, can help prisoners break an addiction.But abstinence does not in and of itself treat substance use disorder. And upon release, prisoners generally have a reduced tolerance for opioids; one study found that within two weeks of being released, former inmates overdose at rates nearly 130 times as high as the general population. HealthOne state takes a novel approach to opioid addiction: access to treatment for all inmates Comparing the Covid-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson Privacy Policy John Young, a prisoner at the Rhode Island Department of Corrections, says medication-assisted treatment will "keep me safe." Aram Boghosian for STAT How effective is medication-assisted treatment for addiction? Here’s the science [email protected] Tags addictionlegalopioidsstates Trending Now: General Assignment Reporter Andrew covers a range of topics, from addiction to public health to genetics.last_img

FDA pushes to bring order to the chaotic world of DNA sequencing

by admin
first_img [email protected] GET STARTED FDA pushes to bring order to the chaotic world of DNA sequencing @megkesh By Meghana Keshavan Aug. 1, 2017 Reprints Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED What is it? Meghana Keshavan For precision medicine to take root, diagnostics also have to be precise. But so far, there isn’t a ton of confidence about the reliability of next-generation sequencing tests. So the Food and Drug Administration is pressing ahead with an ambitious effort to bring order to the chaotic world of DNA sequencing.“The only way we’re really going to move quickly on these new technologies is to collaborate with experts globally,” said Elaine Johanson, acting director of FDA’s Office of Health Informatics. Politics 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. What's included? APStock About the Author Reprints STAT+ is STAT's premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Biotech Correspondent Meghana covers biotech and contributes to The Readout newsletter. Log In | Learn More Tags diagnosticsgeneticspolicySTAT+last_img

Long-awaited study finds monthly Vivitrol as effective as daily pill for opioid addiction

by admin
first_img A former drug czar weighs in: What Trump should have done about the opioid crisis The finding, however, comes with a major caveat. A large number of people were unable to even start treatment with Vivitrol. That’s because participants had to thoroughly wean themselves off opioids for a period of three days before they could start taking Vivitrol, to avoid sudden symptoms of opioid withdrawal. Because of that hurdle, patients failed to start on Vivitrol at four times the rate that they did Suboxone. Spencer Platt/Getty Images Indivior, the company that makes Suboxone, donated drugs to this trial and “had access to periodic safety data only, with no input or review of this manuscript,” according to the study.Volkow, for her part, believes physicians should be prescribing medication out of a series of choices. For instance, Vivitrol might be a better treatment for someone in a rural area because he or she wouldn’t have to drive as frequently to a faraway clinic; chronic pain patients might respond better to Suboxone, as it blocks pain receptors.Ultimately, Volkow feels more long-term research and development of opioid addiction treatments — including extended-release buprenorphine — is needed now to truly know what works best for patients.“They’re not perfect — in this trial 50 percent of the patients relapsed after six months,” Volkow said. “So it behooves us to research more and develop more medications.”David Armstrong contributed reporting. Addiction experts say this study, which confirms the results of a smaller head-to-head trial recently published, offer more clarity at a time where misconceptions have clouded the public’s judgment about treatments for opioid addiction.Costs and benefitsThe research was conducted between 2014 and 2017 at eight community-based inpatient treatment facilities across the U.S. A group of 570 opioid-dependent adults — the majority of whom were white men between the ages of 25 and 45 — received one of the two medication-assisted treatments.Over the subsequent six months, researchers both solicited self-reports of opioid use as well as weekly urine samples. Participants also reported side effects and their level of opioid craving. At the end of six months, 52 percent of those who had received Vivitrol had relapsed, compared with 56 percent of those receiving Suboxone. However, 28 percent of participants assigned to Vivitrol couldn’t make it through the detox period, as compared to 6 percent of people who quit the study before initiating Suboxone dosage. Taking into account all the participants, Suboxone had a lower rate of relapse than Vivitrol. Newsletters Sign up for Morning Rounds Your daily dose of news in health and medicine. The largest head-to-head study to date between two leading drugs to treat opioid addiction has found them roughly equivalent — an outcome that could dramatically change prescribing habits and boost the fortunes of the newer drug, Vivitrol.The study, sponsored by the National Institute on Drug Abuse, found that a monthly shot of naltrexone (sold as Vivitrol) is as effective as its main competitor, the daily pill of buprenorphine and naloxone (sold as Suboxone). Researchers found that about half of people with opioid addiction who took either drug remained free from relapse six months later.Previously, there’s been a “widespread belief” that patients “don’t do as well on naltrexone as they do on buprenorphine,” said Dr. Nora Volkow, director of NIDA. “We’re hopeful this changes the prejudice.”advertisement Leave this field empty if you're human: Vivitrol, which received Food and Drug Administration approval in 2010 for opioid treatment, is seen as attractive option because patients only have to take it once a month, and it doesn’t contain opioids. Suboxone, by contrast, has been treated with skepticism by some physicians and officials — including former Health and Human Services Secretary Tom Price — because it’s “substituting” one opioid for another. But Vivitrol, which costs about $1,000 a shot, is also much more expensive than Suboxone, and up until now has had limited evidence showing how well it works.advertisement HealthLong-awaited study finds monthly Vivitrol as effective as daily pill for opioid addiction center_img Dr. Joshua Lee, an associate professor with New York University’s School of Medicine and a leading author of the study, which published in the Lancet on Tuesday, said the findings indicate that each drug can help certain patients, rather than one simply being better than the other.“Both medications worked quite similarly and, therefore, both should be discussed as treatment options,” Lee told STAT. “The problem is not enough people are getting into treatment anyway, and when they do go into treatment, they don’t get any of these treatment options. Enough of the circular firing squad among the addiction treatment providers, and the war amongst all these different medications.”But other addiction doctors said that the gap in rates of people who successfully started each treatment was an alarming sign.“The take-home from this study is that buprenorphine [Suboxone] is more effective” than Vivitrol, said Dr. Sarah Wakeman, the medical director of the Substance Use Disorders Initiative at Massachusetts General Hospital. She said the study confirmed what she sees at her clinical practice — that it is easier to initiate Suboxone treatment with patients, and patients stay with the treatment longer.She also pointed out that many of the overdoses in the study occurred after detox — a phase that isn’t required if patients are given Suboxone.Dr. Andrew Kolodny, co-director of the Opioid Policy Research Collaborative at Brandeis University, agreed. “Buprenorphine outperformed naltrexone, period,” he said.The need for evidenceOne charge the study does settle is that there is a lack of evidence supporting Vivitrol’s touted effects. Alkermes, which manufactures the drug, was dinged by a number of investigative reports earlier this year highlighting the company’s expansive claims about the drug’s potential to investors and its aggressive lobbying of federal lawmakers.Alkermes did not donate drugs to this trial. But two of study’s senior authors — Lee and Dr. John Rotrosen, a psychiatry professor at NYU’s School of Medicine — had received free drugs from Alkermes for an unrelated trial. Two other researchers involved in the study disclosed receiving either research support or consulting fees from Alkermes in the past. In a statement, Alkermes CEO Richard Pops said the “data from the study reinforce the value of [medication-assisted treatment] and the distinct differences between two important options” for opioid-use disorder. Related: The White House punted to Congress on opioids funding. Congress doesn’t have a plan Please enter a valid email address. By Max Blau Nov. 14, 2017 Reprints Related: Privacy Policylast_img

A big study finds antidepressants are effective in adults, but will it end debate?

by admin
first_img By Ed Silverman Feb. 22, 2018 Reprints Tags mental healthpharmaceuticalspolicySTAT+ STAT+ is STAT's premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. [email protected] Seeking to end a long-running debate over whether antidepressants are truly effective, a group of researchers conducted a sweeping new analysis of hundreds of studies and determined the pills were useful in relieving depression among adults.Although effectiveness and side effects varied, the findings indicated antidepressants were, across the board, more effective than a placebo. Consequently, the results provide “the best currently available evidence base to guide the choice about pharmacological treatment” for adults suffering from depression, the researchers wrote in The Lancet, where the new study was published. GET STARTED A big study finds antidepressants are effective in adults, but will it end debate? Joe Raedle/Getty Images What is it? About the Author Reprintscenter_img Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. @Pharmalot What's included? Log In | Learn More Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Pharmalot Ed Silvermanlast_img

Advocates protest Novartis ‘bullying tactics’ over access to medicines in poor countries

by admin
first_img Nearly a dozen advocacy groups began a series of protests against Novartis this week for using “lies, threats and bribes” to pressure developing countries not to pursue measures to widen access to medicines.The groups are targeting Novartis because the drug maker figures prominently in an intensifying effort by the U.S. Trade Representative and pharmaceutical industry trade groups to lean on the Colombian government to revamp its policies toward pricing and patents. What is it? Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED Pharmalot Joerg Reinhardt, the chairman of Novartis, seen here during the company's general assembly in Basel. Anthony Anex/Keystone via AP Advocates protest Novartis ‘bullying tactics’ over access to medicines in poor countries Log In | Learn More @Pharmalot Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry.center_img [email protected] Ed Silverman About the Author Reprints GET STARTED What's included? By Ed Silverman March 2, 2018 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. Tags drug pricespatentspharmaceuticalsSTAT+last_img