News from Bioethics.com

US Hospitals Grapple with Prolonged Injected Opioid Shortage

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(ABC News) – There is another opioid crisis happening in the U.S., and it has nothing to do with the overdose epidemic: Hospitals are frequently running out of widely used injected painkillers. Manufacturing shortages are forcing many doctors and pharmacists to sometimes ration injected opioids, reserving them for the patients suffering most. Other patients get slower-acting or less effective pain pills, alternatives with more side effects or even sedation.

A Law Professor Explains Why Walgreens Can Deny Birth Control Prescriptions–And How Policies Might Change

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(The Verge) – Walgreens has apologized for how Arteaga’s case was handled, but it said that the employee had not violated company policy. There have long been rules in place that don’t require doctors to assist with medical abortion because of religious or moral obligations. This particular Walgreens is in Arizona, one of six states that lets pharmacies refuse to provide contraception as well, again on religious or moral grounds. Such behavior is protected by the so-called “conscience clause.” (In this particular case, the drug was not for emergency contraception. The baby had stopped developing and Arteaga had written that she would eventually have had a miscarriage.)

Macchiarini Guilty of Misconduct, But Whistleblowers Share Blame, New Karolinska Institute Verdict Finds

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(Science Magazine) – The Karolinska Institute (KI) in Stockholm has finally, officially, found disgraced surgeon Paolo Macchiarini guilty of scientific misconduct. Macchiarini was widely hailed as a pioneer in regenerative medicine for his technique of implanting artificial tracheae seeded with a patient’s own stem cells into patients, but KI fired him in 2016 amid allegations of fraud and other types of misconduct. However, the verdict is a bitter pill for the four people who raised the alarm about Macchiarini’s fraud.

ALS Drug Maker Walks Back Plan to Profit from Right-to-Try Law Following Heavy Criticism

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(STAT News) – In the end, BrainStorm Cell Therapeutics’ dalliance with the newly enacted right-to-try law was little more than a publicity stunt. On Tuesday, the small biotech company said it would not offer its experimental stem cell therapy to patients with amyotrophic lateral sclerosis, or ALS, outside of an ongoing Phase 3 clinical trial. Just last week, BrainStorm CEO Chaim Lebovits had told Bloomberg that the company planned by take advantage of the new right-to-try law by selling its unapproved treatment, known as NurOwn, to ALS patients who could afford the high cost — as much as $300,000. Lebovits described the initiative as a “semi-commercial enterprise” that would generate “modest profits.”

Abortion Complications as Common in Clinics as ‘Surgery Centers’

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(Medical Xpress) – More than a dozen US states have laws that require abortion clinics to meet hospital surgical standards, but a study published Tuesday found these standards unnecessary, expensive, and no safer than office settings. That’s because of more than 50,000 abortions analyzed from 2011 to 2014, just three percent had some kind of complication, including hemorrhage, missed ectopic pregnancy, and infection. There was no statistically significant difference whether the procedure took place in an ambulatory surgical center or an office-based setting, said the report in the Journal of the American Medical Association (JAMA).

The Supreme Court Hands a Win to the Pro-Life Movement

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(The Atlantic) – The Supreme Court handed a big win to the pro-life movement on Tuesday. In a five-to-four decision in NIFLA v. Becerra, the justices ruled that California can’t force crisis-pregnancy centers to post signs about state-sponsored abortion services, regardless of whether those facilities are licensed medical providers or not. The decision vindicated pro-life advocates who have long argued that states and cities unfairly target these centers, which exist to provide alternative pregnancy services to women who don’t want abortions. Even more importantly, the decision vindicated pro-life voters, who look to the Supreme Court to limit abortion rights in America.

Hundreds of New Genes May Underlie Intelligence–But Also Autism and Depression

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(Science) – Being smart is a double-edged sword. Intelligent people appear to live longer, but many of the genes behind brilliance can also lead to autism, anxiety, and depression, according to two new massive genetic studies. The work also is one of the first to identify the specific cell types and genetic pathways tied to intelligence and mental health, potentially paving the way for new ways to improve education, or therapies to treat neurotic behavior.

Raid on Surrogacy Agency Nets Five

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(The Phnom Penh Post) – Anti-human trafficking police in Phnom Penh’s Russey Keo district arrested five people on Thursday, including a Chinese national, and discovered 33 women who were paid to have children for Chinese clients, the unit’s chief said on Sunday. Keo Thea, the Phnom Penh anti-trafficking police chief, said Chinese national Liu Qiang, 49, was the alleged mastermind of the surrogacy ring. Four Cambodian women – Svay Sinuch, 34; Noeun Sreylang, 27; Lim Sopheap, 19; and Thai Pheap, 43 – were also arrested for abetting him.

‘Conscientious Objection’: When Doctors’ Beliefs Are a Barrier to Abortion

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(The Guardian) – A rise in the number of healthcare providers who refuse to provide abortion services based on their personal beliefs is having a devastating impact on women and girls around the world, a new study has claimed. Over the past two decades, at least 30 countries – including, most recently, Ireland, Chile and Argentina – have taken steps to improve access to abortion through legislative changes. Many medics have sought to exempt themselves from these new laws, however.

Massive Genetic Study Finds Links Between Various Psychiatric Illnesses

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(Gizmodo) – An excavation of a million people’s genes has provided some interesting clues to how several common psychiatric disorders might arise, including major depression and schizophrenia. And it’s also highlighted connections between some mental illnesses and other health problems, including heart disease. An international group of researchers from the US, UK, China, Singapore, Japan, and Australia collaborated for the project, dubbed the Brainstorm Study.

Number of Canadians Choosing Medically Assisted Death Jumps 30%

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(CBC) – There were 1,523 medically assisted deaths in Canada in the last six-month reporting period — a nearly 30 per cent increase over the previous six months. Cancer was the most common underlying medical condition in reported assisted death cases, cited in about 65 per cent of all medically assisted deaths, according to the report from Health Canada. Using data from Statistics Canada, the report shows medically assisted deaths accounted for 1.07 per cent of all deaths in the country over those six months.

Here Come the Right-to-Try Profiteers. The FDA Is Powerless to Stop Them

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(STAT News) – The newly enacted right-to-try law allows drug makers to earn a profit by selling unproven therapies to desperate and dying patients. The FDA is powerless to stop it. You’d think no drug maker would be dumb enough to actually try to make money this way, given prevailing public opinion that already views the drug industry as greedy, price-gouging profiteers.

Doling Out Pain Pills Post-Surgery: An Ingrown Toenail Not the Same as a Bypass

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(Kaiser Health News) – What’s the right painkiller prescription to send home with a patient after gallbladder surgery or a cesarean section? That question is front and center as conventional approaches to pain control in the United States have led to what some see as a culture of overprescribing, helping spur the nation’s epidemic of opioid overuse and abuse. The answer isn’t clear-cut. Surgeon Marty Makary wondered why and what could be done.

Pain Is Weird. Making Bionic Arms Feel Pain Is Even Weirder

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(Wired) – Pain is an indispensable tool for survival. The prick of a nail underfoot is a warning that protects you from a deep, dirty wound—and maybe tetanus. The sizzle of a steel skillet is a deterrent against a third-degree burn. As much as it sucks, pain, oddly enough, keeps us from hurting ourselves. It’s a luxury that prosthetic users don’t have. But researchers report in Science Robotics that they’ve developed a prosthesis that can feel sharp pain and automatically drop a pointy object—in addition to telegraphing that pain to the wearer.

The ‘Right to Try’ Could Cost Dying Patients a Fortune

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(Bloomberg) – A small biotechnology company may be the first to offer dying patients unproven drugs under a new U.S. law called Right to Try that deregulated access to such experimental treatments. But it won’t be for free: Brainstorm Cell Therapeutics Inc. would charge for a therapy it is developing for the deadly condition known as Lou Gehrig’s disease. While details are still being worked out, the company’s chief executive officer pointed to the price of bespoke cell therapies used to treat cancer that cost more than $300,000.

First Phage Therapy Center in the U.S. Signals Growing Acceptance

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(STAT News) – That was 2016. Phage therapy is still very much experimental — but it’s come a long way since then. New companies have popped up, hoping to get approval to sell these viruses as drugs. A phage directory has come together, lab by lab, helping doctors figure out who has which virus. Now, the U.S. is getting its first phage therapy center, at the University of California, San Diego. Its mission is to run clinical trials, but also to streamline the mad dash to secure the right phage before a patient dies.

With FDA Input, Compassionate Use Programs Appear to Work Well: Study

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(Reuters) – When terminally ill Americans receive experimental medicines through so-called “compassionate use” programs, they typically only get these drugs after extensive tests for safety and effectiveness, a U.S. study suggests.

The Scientific Controversy Over Whether Gaming Addiction Is a Disease–Or a Symptom

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(Quartz) – Scholars from around the world are already debating WHO’s move. In a letter of concern published on November 9, 2016, a dozen academics write that “the premature inclusion of Gaming Disorder as a diagnosis in ICD-11 will cause significant stigma to the millions of children who play video games as a part of a normal, healthy life.” They warn that a “moral panic” over gaming might lead kids with normal gaming habits to be diagnosed as having a disorder, which could stigmatize them and set them on a course of treatment they don’t need.

Facebook to Redirect Users Searching for Opioids to Federal Crisis Help Line

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(STAT News) – Facebook users attempting to purchase opioids or seeking out addiction treatment will be instead be redirected to information about a federal crisis help line, the company announced Tuesday, a major step for an industry leader facing pressure to more aggressively police illicit drug sales on its platform. The announcement comes a week before an “opioids summit” convened by the Food and Drug Administration to get Facebook and other tech companies, including Twitter and Google, to take additional measures to help curb the nation’s opioid crisis.

California’s Assisted-Dying Law Reinstated Three Weeks after It was Blocked

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(San Francisco Chronicle) – California’s assisted-dying law, which allows terminally ill adults to receive life-ending drugs from a doctor, was reinstated by a state appeals court Friday, three weeks after a judge halted its enforcement. The Fourth District Court of Appeal in Riverside issued a brief order granting an “immediate stay” of the judge’s May 25 ruling that said the law was enacted illegally during a special legislative session on health care. It had been in effect since June 2016. The appeals court gave opponents of the law, a group of doctors represented by the Life Legal Defense Foundation, until July 2 to file arguments explaining why the decision should be reversed. The law will remain in effect while the court considers the arguments.

Controversial NIH Study of ‘Moderate Drinking’ Will Be Terminated after Scathing Report

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(STAT News) – The National Institutes of Health will shut down a controversial industry-funded study of moderate drinking and heart disease after a task force found severe ethical and scientific lapses in the study’s planning and execution, the agency’s director said Friday. The way NIH officials secured funding for the research “casts doubt” on whether “the scientific knowledge gained from the study would be actionable or believable,” according to the task force’s scathing presentation to NIH officials.

With Tantalizing Early Results, Sarepta’s Gene Therapy for Duchenne Raises Hopes for ‘Real Change’

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(STAT News) – An experimental gene therapy for Duchenne muscular dystrophy, licensed to Sarepta Therapeutics, produced jaw-dropping increases in a crucial muscle protein normally missing in patients with the disease, according to preliminary clinical trial data released Tuesday. The data were collected from just three boys, but the effect of the gene therapy — producing 38 percent of a truncated form of the normal dystrophin muscle protein — is profound enough to suggest it may halt or even reverse the effects of Duchenne in certain patients.

Results of At-Home Genetic Tests for Health Can Be Hard to Interpret

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(NPR) – Now, more people are getting their DNA analyzed for health reasons, in the comfort of their own homes. As genetic testing has gotten easier, faster and more affordable, it has become a multimillion-dollar industry, with many companies aggressively marketing convenient, inexpensive tests directly to consumers. About one-third of Americans say they or a family member have considered getting a genetic test, according to a recent NPR-IBM Watson Health Poll. And millions of people have gotten them, for a variety of reasons.

Scientists Edit Heart Muscle Gene in Stem Cells, May Be Able to Predict Risk

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(CNN) – In our human genome, there are many elusive genetic variants related to medical conditions, but the impact of these variants to actually cause a disease has not been conclusively determined — or ruled out.  In other words, the impact certain variants could have on your health remains a guessing game. But a new study involving the gene-editing tool CRISPR could change that.

New Bluebird Data Show Promising Benefits for Gene Therapy, If They Last

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(STAT News) – New versions of Bluebird Bio’s gene therapy for inherited blood disorders yielded significant benefits for patients, according to updated results from ongoing clinical trials released Friday. But whether those benefits will endure for the patients with those conditions, beta-thalassemia and sickle cell disease, remains an open question, even as the Cambridge-based biotech prepares to submit for its first marketing approval in Europe by the end of the year.

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