organization:u.s. food and drug administration

  • Liquid used in e-cigarettes damages cells crucial for a healthy heart - EHN
    https://www.ehn.org/vaping-hurts-your-heart-2638041485.html

    The flavors used in e-cigarettes—especially menthol and cinnamon—damage blood vessel cells and such impacts increase heart disease risk, according to a new study.

    The study, published today in the Journal of the American College of Cardiology, is the latest to link e-cigarettes, or vaping — which has been touted as a safer alternative to smoking cigarettes—to heart problems. It is the first study to test how e-liquids affect the endothelial cells that line the interior of blood vessels. These cells are crucial in delivering the blood supply to the bodies’ tissues and sending cells to promote healthy blood vessels, tissue growth and repair.

    E-cigarettes are small devices that heat up liquids (usually propylene glycol or glycerol) to deliver as aerosol (vape) mixture of nicotine and flavors.

    The study comes as e-cigarette use continues to rise. Roughly 1 in 20 U.S. adults now use e-cigarettes but the real growth is happening among youth: use among U.S. high school students went from 11.7 percent in 2017 to 20.8 percent in 2018, according to the U.S. Food and Drug Administration. In addition, about 4.9 percent of middle school students use e-cigarettes, the FDA found.

    The study was limited in that the e-liquids weren’t heated, which could alter how the exposed cells react. The research, however, is just the latest linking e-cigarettes to heart impacts.

    In March, researchers presented a study of nearly 100,000 Americans that found e-cigarette users are more likely to suffer heart attacks and strokes compared to non-users.

    Another large national study in January of 400,000 Americans reported e-cigarette users have a 70 percent higher risk of stroke and a 60 percent higher risk of heart attack, when compared to non-users.

    With use rising, health groups continue to push for more strict regulation. A judge this month ordered the FDA to review all U.S. e-cigarette products.

    The ruling was a response to a federal lawsuit filed by health groups, including the American Academy of Pediatrics and the Campaign for Tobacco-Free Kids, that alleged the FDA hasn’t adequately regulated e-cigarettes and is leaving a generation of U.S kids on the path to nicotine addiction.

    #Tabac #E_cigarettes #Vaping #Santé_publique

  • Exclusive: OxyContin Maker Purdue Pharma Exploring Bankruptcy - Sources | Investing News | US News
    https://money.usnews.com/investing/news/articles/2019-03-04/exclusive-oxycontin-maker-purdue-pharma-exploring-bankruptcy-sources

    By Mike Spector, Jessica DiNapoli and Nate Raymond

    (Reuters) - OxyContin maker Purdue Pharma LP is exploring filing for bankruptcy to address potentially significant liabilities from roughly 2,000 lawsuits alleging the drugmaker contributed to the deadly opioid crisis sweeping the United States, people familiar with the matter said on Monday.

    The potential move shows how Purdue and its wealthy owners, the Sackler family, are under pressure to respond to mounting litigation accusing the company of misleading doctors and patients about risks associated with prolonged use of its prescription opioids.

    Purdue denies the allegations, arguing that the U.S. Food and Drug Administration-approved labels for its opioids carried warnings about the risk of abuse and misuse associated with the pain treatments.

    Filing for Chapter 11 protection would halt the lawsuits and allow Purdue to negotiate legal claims with plaintiffs under the supervision of a U.S. bankruptcy judge, the sources said.

    Shares of Endo International Plc and Insys Therapeutics Inc, two companies that like Purdue have been named in lawsuits related to the U.S. opioid epidemic, closed down 17 percent and more than 2 percent, respectively, on Monday.

    More than 1,600 lawsuits accusing Purdue and other opioid manufacturers of using deceptive practices to push addictive drugs that led to fatal overdoses are consolidated in an Ohio federal court. Purdue has held discussions to resolve the litigation with plaintiffs’ lawyers, who have often compared the cases to widespread lawsuits against the tobacco industry that resulted in a $246 billion settlement in 1998.

    “We will oppose any attempt to avoid our claims, and will continue to vigorously and aggressively pursue our claims against Purdue and the Sackler family,” Connecticut Attorney General William Tong said. Connecticut has a case against Purdue and the Sacklers.

    BANKRUPTCY FILING NOT CERTAIN

    A Purdue bankruptcy filing is not certain, the sources said. The Stamford, Connecticut-based company has not made any final decisions and could instead continue fighting the lawsuits, they said.

    “As a privately-held company, it has been Purdue Pharma’s longstanding policy not to comment on our financial or legal strategy,” Purdue said in a statement.

    “We are, however, committed to ensuring that our business remains strong and sustainable. We have ample liquidity and remain committed to meeting our obligations to the patients who benefit from our medicines, our suppliers and other business partners.”

    Purdue faces a May trial in a case brought by Oklahoma’s attorney general that, like others, accuses the company of contributing to a wave of fatal overdoses by flooding the market with highly addictive opioids while falsely claiming the drugs were safe.

    Last year, U.S. President Donald Trump also said he would like to sue drug companies over the nation’s opioid crisis.

    Opioids, including prescription painkillers, heroin and fentanyl, were involved in 47,600 overdose deaths in 2017, a sixfold increase from 1999, according to the latest data from the U.S. Centers for Disease Control and Prevention.

    Purdue hired law firm Davis Polk & Wardwell LLP for restructuring advice, Reuters reported in August, fueling concerns among litigants, including Oklahoma Attorney General Mike Hunter, that the company might seek bankruptcy protection before the trial.

    Companies facing widespread lawsuits sometimes seek bankruptcy protection to address liabilities in one court even when their financial condition is not dire. California utility PG&E Corp filed for bankruptcy earlier this year after deadly wildfires raised the prospect of large legal bills even though its stock remained worth billions of dollars.

    DECEPTIVE MARKETING

    Massachusetts Attorney General Maura Healey in June became the first attorney general to sue not just Purdue but Sackler family members. Records in her case, which Purdue has asked a judge to dismiss, accused Sackler family members of directing deceptive marketing of opioids for years while enriching themselves to the tune of $4.2 billion.

    Some other states have since also sued the Sacklers. The Sacklers are currently discussing creating a nonprofit backed by family financial contributions to combat addiction and drug abuse, a person familiar with their deliberations said.

    The drugmaker downplayed the possibility of a bankruptcy filing in a Feb. 22 court filing in the Oklahoma case. “Purdue is still here - ready, willing and eager to prove in this Court that the State’s claims are baseless,” the company said in court papers.

    Sales of OxyContin and other opioids have fallen amid public concern about their addictive nature, and as restrictions on opioid prescribing have been enacted. OxyContin generated $1.74 billion in sales in 2017, down from $2.6 billion five years earlier, according to the most recent data compiled by Symphony Health Solutions.

    Purdue Chief Executive Officer Craig Landau has cut hundreds of jobs, stopped marketing opioids to physicians and moved the company toward developing medications for sleep disorders and cancer since taking the helm in 2017.

    In July, Purdue appointed a new board chairman, Steve Miller, a restructuring veteran who previously held leadership positions at troubled companies including auto-parts giant Delphi and the once-teetering insurer American International Group Inc.

    Mortimer D.A. Sackler no longer sits on Purdue’s board, according to a filing the company made with the Connecticut secretary of state late Monday.

    The Oklahoma case and other lawsuits seek damages from Purdue and other pharmaceutical companies accused of fueling the opioid crisis. In addition to lawsuits consolidated in an Ohio federal court, more than 300 cases are pending in state courts, and dozens of state attorneys general have sued manufacturers, including Purdue.

    Settlement discussions have not yet resulted in a deal.

    Purdue and three executives in 2007 pleaded guilty to federal charges related to the misbranding of OxyContin and agreed to pay a total of $634.5 million in penalties, according to court records.

    (Reporting by Mike Spector and Jessica DiNapoli in New York and Nate Raymond in Boston; Editing by Bill Berkrot)

    Copyright 2019 Thomson Reuters.

    #Opioides #Sackler #Bankruptcy

  • Opioid crisis engulfs blockaded Gaza Strip
    https://www.apnews.com/ff3cf542ded542d5b2e51ceb3fbe051c

    GAZA CITY, Gaza Strip (AP) — An opioid crisis has quietly spread in the Gaza Strip, trapping thousands in the hell of addiction and adding another layer of misery to the blockaded and impoverished coastal territory.

    The scourge can be traced to the mass import of cheap opioid-based Tramadol pain pills through smuggling tunnels under Gaza’s border more than a decade ago. A more addictive black-market form of the drug called Tramal has since taken hold.

    “I have seen the top elites taking it — university students, girls and respectful people,” said Dr. Fadel Ashour, who treats addicts in his dimly lit clinic.

    Tramadol, a synthetic opioid analgesic, is considered a controlled substance by the U.S. Food and Drug Administration, in the same category as well-known medications like Valium and Xanax.

    The WHO study cited the blockade, high unemployment among university graduates and never-ending conflict with Israel as factors associated with “widespread” Tramadol abuse.

    It said users turned to the drug to “escape problems,” obtain a “feeling of relaxation,” to “not think” and to fall asleep.

    Tramal, believed to be a more addictive black market form of Tramadol, arrived later, gaining popularity after the first war between Hamas and Israel in 2009.

    Tramal was cheap, less than 50 cents a tablet, and people discovered its sedative effects at a time when they were “trying to overcome their anxiety because Gaza was a very traumatic environment,” said Dr. Ashour.

    But in recent months, prices have shot up. A single pill can cost about $20, well beyond most people’s means.

    Being a health worker himself, Abu Karim was able to get prescriptions to buy the milder Tramadol legally and more affordably.

    “It was not as powerful as the smuggled Tramal, but with more pills, it does part of the job,” he said.

    Today, he’s among the few patients at the Hope Center, the first and only rehab facility in Gaza. Since opening at Gaza’s only psychiatric hospital in 2017, it has treated 230 people, 90 percent of them tramadex users.

    Nearly a year of border protests against the Israeli blockade have added a new element to the crisis. Hundreds of young men have been shot by the Israeli army, which says it is defending its border.

    Mahmoud, a 29-year-old, said he became addicted to Lyrica after he was shot during a protest. Unemployed and unmarried, he is now being treated by Dr. Ashour.

    “I don’t want to reach a level in which I lose my personality and dignity because of the drugs,” said Mahmoud, who would not give his family name because of the social stigma associated with addiction. “I want to stop.”

    #Opioides #Gaza #Addiction

  • Are women more likely to be harmed by medical device failures? - ICIJ
    https://www.icij.org/blog/2018/12/are-women-more-likely-to-be-harmed-by-medical-device-failures

    The best source for gender-specific data on injuries and deaths linked to medical devices should be the U.S. Food and Drug Administration. The FDA collects that information in “adverse event” reports filed by manufacturers, doctors and others when a device has harmed a patient – or has experienced a malfunction that would lead to harm if it were to recur. An ICIJ analysis of this data identified more than 83,000 deaths and 1.7 million injuries linked to medical devices.

    Yet the FDA won’t make gender information public. An agency spokeswoman told ICIJ that revealing gender or age would violate patient confidentiality rules and that more broadly, “conclusions can not be drawn” about sex-specific differences in adverse event rates, because the reports themselves often contain unverified and incomplete information.

    #sexisme_médical #santé #implants #santé_publique #femmes

    • … More than 10 million people have received breast implants over the last decade, and more than 1 million have gotten Essure, which as of the end of this year will have been pulled from the market in every country. Hundreds of thousands have had a mesh implant. There is no comparable group of male-focused products with these kinds of widespread problems.

  • Implant Files - ICIJ
    https://www.icij.org/investigations/implant-files

    Health authorities across the globe have failed to protect millions of patients from poorly tested implants, the first-ever global examination of the medical device industry reveals.

    83 000 morts, 1,7 millions de victimes du manque de régulation des prothèses et implants. Méga enquête de l’ICIJ.

  • How to Spend $1,900 on Gene Tests Without Learning a Thing - MIT Technology Review
    https://www.technologyreview.com/s/609103/how-to-spend-1900-on-gene-tests-without-learning-a-thing

    But instead of air purifiers, bacon toasters, and other electronic gadgets that no one really needs, people with money to burn can spend $149 on a scarf whose pattern is personalized using their genes, DNA diet apps, or even genetically influenced wine recommendations.

    Eric Topol, an influential heart doctor and geneticist at the Scripps Research Institute in La Jolla, California, says he’s had enough. To Topol, too many of these apps amount to genetic astrology. “The data has no basis. It’s pseudoscience—complete, utter nothing,” he says. He calculated that a consumer could spend $1,900 on 17 apps and learn almost nothing of value.

    Earlier this year, the U.S. Food and Drug Administration signaled that it would unwind what had been a de facto ban on a range of direct-to-consumer gene reports. What’s followed has been a quick expansion of gene tests that range from reasonable to downright silly.

    Aside from Helix, many others are selling DNA tests, too. One, being advertised on TV, is “Soccer Genomics,” which promises a “personalized report that will help guide player development.” And for $99, a company called Orig3n will sell you a test that claims to predict your kid’s ability to learn languages. Last month, that company had to cancel a planned giveaway of DNA tests at a Baltimore Ravens game, after objections from state regulators.

    Mais ils ne sont responsables de rien... un peu comme les plateformes et les fake-news... ce sont ceux qui y croient qui ont tort. Ben voyons.

    In response to critics, Helix cofounder Justin Kao cautions against a “paternalistic” attitude toward what kind of information consumers should be able to spend their money on. “People should be able to choose how they want to interact and experience DNA-powered insights and decide for themselves what is of value to them,” he says.

    #Génomique #Tests_génétiques #DTCtests #Arnaques

  • Why Did That Drug Price Increase 6,000%? It’s The Law
    http://www.forbes.com/sites/matthewherper/2017/02/10/a-6000-price-hike-should-give-drug-companies-a-disgusting-sense-of-deja-vu

    a pharmaceutical company in Deerfield, Ill., has gotten approval from the U.S. Food and Drug Administration to sell deflazacort (snazzy brand name: Emflaza). The company, Marathon Pharmaceuticals, is charging a list price of $89,000 – a 6,000% price increase.

    If this doesn’t feel like déjà vu all over again, you haven’t been paying attention.

    #pharma #prix #brevets #États-Unis

  • FDA Asks How Safe Is That Hand Sanitizer?
    https://consumer.healthday.com/general-health-information-16/hygiene-health-news-396/fda-asks-how-safe-is-that-hand-sanitizer-712441.html

    Millions of Americans use hand sanitizers every day, believing they safely kill bacteria. Now, the U.S. Food and Drug Administration wants to find out if that’s really true.

    The agency Wednesday requested makers of antibacterial hand sanitizers and related products to provide data showing the products’ active ingredients actually reduce bacteria and are harmless over time.

    Of particular concern are the long-term effects of these sanitizers on pregnant women and children, the agency said.
    […]
    Officials said the request stems from new research and recommendations from an independent advisory committee of scientific and medical experts.

    Recent research has found that levels of antiseptic ingredients in users’ urine and blood are higher than previously thought. This raises questions regarding absorption, since these antiseptics aren’t washed off, the agency explained.

  • Israel to probe birth control for Ethiopian immigrants | Maan News Agency
    http://www.maannews.net/eng/ViewDetails.aspx?ID=570216

    JERUSALEM (Reuters) — Israel’s Health Ministry has ordered an investigation into whether government employees or health workers prescribed a birth control drug to Ethiopian immigrant women as a way to control the population.

    Haaretz reported on Thursday that a senior official had decided to name a team to look into charges that Ethiopian women were given Depo-Provera shots in an effort to limit the growth of their community in Israel.

    Confirming the report, a ministry spokeswoman replied in a written statement that the ministry would “re-investigate the issue which was examined in the past, to ensure that there was no such directive from any governmental or other Israeli public organization.”

    Suspicions that Ethiopian women had been coerced into receiving Depo-Provera arose in Israeli media a few years ago and again in a recent TV documentary linking the group’s falling birthrate to over-prescription of the injectable contraceptive.

    Israel’s government already said in January it would review the case after a civil rights group accused the health ministry of racism.

    The ministry has already ordered doctors not to renew Depo-Provera prescriptions unless they were convinced patients understood the ramifications, according to a letter from the ministry posted on the group’s website in January.

    Ministry Director-General Roni Gamzu said at the time that the decision did not imply he accepted the allegations by the Association of Civil Rights in Israel.

    In a letter to Gamzu in January, ACRI said "the sweeping use of Depo-Provera among Ethiopian women raises heavy suspicions that we are talking about a deliberate policy to control and monitor fertility among this community.

    “The data ... point to a paternalistic, haughty and racist attitude that limits considerably the freedom of Ethiopian immigrants to choose the birth control that is medically suitable for them.”

    ACRI said statistics from a major Israeli health provider showed it had administered Depo-Provera injections to 5,000 women in 2008, 57 percent of whom were Ethiopian.

    Complaints of discrimination

    Israel has denied any policy to curb the birthrate among the 100,000 Ethiopian Jews who have moved to Israel since chief rabbis determined in 1973 that the community had biblical roots.

    Some Ethiopian Jews have made it into Israel’s parliament and officer ranks in the military, but complaints of discrimination in schooling and housing are common.

    According to the U.S. Food and Drug Administration, which approved Depo-Provera in 1992, its prolonged use may reduce bone density and it should only be used for longer than two years if other birth control methods prove inadequate.

    The documentary, broadcast on Israeli Educational Television, shows a nurse filmed by a hidden camera saying Ethiopian women were given Depo-Provera because they “don’t understand anything” and would forget to take birth control pills.

    Rick Hodes, medical director in Ethiopia for the American Jewish Joint Distribution Committee, a non-governmental group that aids immigration to Israel, denied the accusation that women are coerced into receiving the injections before leaving their country for the Jewish state.

    “Injectable drugs have always been the most popular form of birth control in Ethiopia, as well as among women in our program,” Hodes wrote on Twitter.

  • Oceana Study Reveals Seafood Fraud Nationwide
    http://oceana.org/en/news-media/publications/reports/oceana-study-reveals-seafood-fraud-nationwide

    Étiquetage incorrect des poissons aux États-Unis
    Oceana publie les résultats d’une vaste enquête. Le communiqué de presse. 1215 échantillons de poisson étudié par analyse de l’ADN.

    From 2010 to 2012, Oceana conducted one of the largest seafood fraud investigations in the world to date, collecting more than 1,200 seafood samples from 674 retail outlets in 21 states to determine if they were honestly labeled.

    DNA testing found that one-third (33 percent) of the 1,215 samples analyzed nationwide were mislabeled, according to U.S. Food and Drug Administration (FDA) guidelines.

    Of the most commonly collected fish types, samples sold as snapper and tuna had the highest mislabeling rates (87 and 59 percent, respectively), with the majority of the samples identified by DNA analysis as something other than what was found on the label. In fact, only seven of the 120 samples of red snapper purchased nationwide were actually red snapper. The other 113 samples were another fish.

    Our findings demonstrate that a comprehensive and transparent traceability system – one that tracks fish from boat to plate – must be established at the national level. At the same time, increased inspection and testing of our seafood, specifically for mislabeling, and stronger federal and state enforcement of existing laws combatting fraud are needed to reverse these disturbing trends.

    Le résumé du rapport (6 pages) : http://oceana.org/sites/default/files/National_Seafood_Fraud_Testing_Results_Highlights_FINAL.pdf

    Le rapport détaillé (69 pages) : http://oceana.org/sites/default/files/reports/National_Seafood_Fraud_Testing_Results_FINAL.pdf

    Une petite sélection.

    Analyse par type de points de vente (magasins d’alimentation y compris quelques marchés, restaurants, vendeurs de sushi)

    Analyse par poisson

    pb : snapper est un nom très générique, je ne suis pas ichtyologue et la traduction est d’autant plus problématique que les dénominations françaises sont parfois très floue (cf. WP, l’article Rouget… http://fr.wikipedia.org/wiki/Rouget )

    Parmi les traductions de Lutjanidae sur ITIS http://www.itis.gov/servlet/SingleRpt/SingleRpt?search_topic=TSN&search_value=168845
    Perche de mer, vivaneau
    mais aussi
    red snapper : rouget (?)
    grey snapper : dorade grise

    Les substituts du snapper par PV

    Les substituts du thon

    L’escolar, escolier en français poisson des abysses de la famille des Gempylidae, massivement substitué au thon contient une forte proportion d’esters cireux, non digestibles. Il n’est pas toxique mais son ingestion peut provoquer des réactions indésirables chez certains consommateurs (forte diarrhée, nausées,…) cf. sur le site de Santé Canada http://www.hc-sc.gc.ca/fn-an/securit/facts-faits/escolar-escolier-fra.php

  • FDA Grants Priority Review to J&J’s Bedaquiline Tuberculosis Treatment - WSJ.com
    http://online.wsj.com/article/BT-CO-20121231-703447.html

    The U.S. Food and Drug Administration approved Johnson & Johnson’s (JNJ) drug to treat a form of resistant tuberculosis that is uncommon in the U.S. but growing globally.

    The drug, Sirturo, will treat patients with multidrug resistant tuberculosis, or MDR-TB, a possibly fatal disease that affects as many as 630,000 people world-wide who can’t be cured with existing therapies alone. Tuberculosis is a bacterial infection that mostly involves the lungs.

    Sirturo, also known as bedaquiline, is not expected to be a large moneymaker for Johnson & Johnson, one of the world’s largest health-care conglomerate, because the disease is prevalent in poorer countries unable to afford high prices for the treatment. Providing the drug, though, could help the company create goodwill among regulators, governments and patients around the world.

    “The commercial opportunity is very limited,” said Pamela Van Houten, a J&J spokesperson. “This is part of our commitment to advance innovative medicines that help address serious public health issues.”

    #tuberculose #mdrtb #brevets #pharma #santé

    et dans Nature :
    http://blogs.nature.com/news/2013/01/at-long-last-a-new-weapon-against-tuberculosis.html

  • Searching for Side Effects - WSJ
    http://online.wsj.com/article/SB10001424052970203920204577193052426275904.html

    The U.S. Food and Drug Administration has millions of such “adverse event” reports, ranging from fatigue to fatal heart attacks, for thousands of prescription drugs dating back to 1969. But the information hasn’t been readily accessible—until now.

    A start-up company, AdverseEvents Inc., has streamlined the FDA’s often impenetrable database and made it easy to search the adverse-event reports for more than 4,500 drugs, free and online.

    http://adverseevents.com

    #pharma #santé #recherche