News from Bioethics.com

Controversial US Ketamine Trial Sparks Ethics Debate

2 months 3 weeks

(Nature) – A consumer-advocacy group is filing a complaint with the US government about two clinical trials in Minnesota that allegedly gave agitated patients ketamine and other sedatives without their consent, despite evidence that doing so could harm their health. The trials were conducted by researchers at Hennepin County Medical Center (HCMC) in Minneapolis, Minnesota, between 2014 and June 2018. In its complaint, the advocacy group Public Citizen in Washington DC alleges that the studies’ organizers and the HCMC’s ethics-review board allowed the trials to proceed without obtaining consent from patients.

Sarepta Halts Early-Stage Gene Therapy Trial for DMD

2 months 3 weeks

(STAT News) – Sarepta Therapeutics’ clinical trial for a gene therapy to treat Duchenne muscular dystrophy has been paused by the Food and Drug Administration because some of the materials used in the treatment weren’t as they should be, the company announced Wednesday. A stray DNA fragment was found “in connection with routine quality assurance testing” of the plasmids used in the company’s gene therapy, said Douglas Ingram, Sarepta’s president and CEO. Plasmids carry the genetic material used in gene therapy into a cell. The FDA notified Nationwide Children’s Research Institute, where the trial is being conducted, of the clinical hold on Tuesday.

Doctor in Netherlands ‘Asked Family to Hold Down Euthanasia Patient’

2 months 3 weeks

(The Guardian) – A doctor is under criminal investigation over a potential breach of Dutch euthanasia laws after slipping a sleeping drug into a woman’s coffee before asking family members to hold her down to allow the insertion of a drip through which a fatal dose could be administered. The Dutch medical complaints board has reprimanded the doctor, who retired in after her treatment of the 74-year-old patient, who had been suffering from severe dementia. The chief public prosecutor in The Hague is examining if there are grounds for criminal charges.

Revealed: Three Children Are Among Thousands to Die from Euthanasia Under Belgium’s Radical Laws

2 months 3 weeks

(Daily Mail) – Three children are among thousands of people to have died under Belgium’s radical euthanasia regime, figures reveal. They were euthanised under the world’s only law that allows children of any age to choose to be put to death – a move opponents warn trivialises the value of life. An official report has revealed the annual number of euthanasia cases across all age groups has multiplied almost fivefold in ten years. The practice was legalised in Belgium in 2003 – a year after the Netherlands. In 2007, 495 Belgians chose to die this way.

One Woman’s Race to Defuse the Genetic Time Bomb in Her Genes

2 months 3 weeks

(MIT Technology Review) – Vallabh’s race to prevent her own prion disease raises a question for the genetic age. Given a perfect DNA blueprint of your inherited disease, what’s your chance of stopping it in your lifetime, or that of someone you love? There are reasons to think these types of medical long shots have become more likely to hit the mark. That is because gene sequencing can cheaply reveal molecular flaws, but also because a set of promising technologies—antisense, gene therapy, and CRISPR gene editing—are able to replace genes or silence them, in effect fixing genetic problems at their source.

An Enormous Study of the Genes Related to Staying in School

2 months 3 weeks

(The Atlantic) – Over the past five years, Benjamin has been part of an international team of researchers identifying variations in the human genome that are associated with how many years of education people get. In 2013, after analyzing the DNA of 101,000 people, the team found just three of these genetic variants. In 2016, they identified 71 more after tripling the size of their study. Now, after scanning the genomes of 1,100,000 people of European descent—one of the largest studies of this kind—they have a much bigger list of 1,271 education-associated genetic variants.

Profiles for Sale: How Bits of Captured Data Paint a Valuable Picture of Your Health

2 months 3 weeks

(Kaiser Health News) – It would be illegal under patient privacy laws for your doctor to reveal information about your diseases, unhealthy habits or weight. But much can be inferred from your purchases and other interactions, such as online surveys, store loyalty programs, social media and public records. And the resulting “profiles” have wide-ranging applications for groups that buy them, including drug companies, advertisers and insurers.

Hospitals Gear Up for New Diagnosis: Human Trafficking

2 months 3 weeks

(Kaiser Health News) – There are no hard figures for how many people are involved in human trafficking, the term used when individuals are forced to work or have sex for someone else’s commercial benefit. Polaris, a Washington, D.C.-based nonprofit that advocates for these people and runs help lines for them, said calls and texts to its national hotlines have steadily ticked up in recent years, increasing the number of cases 13 percent between 2016 and 2017, to 8,759. But health care providers frequently fail to recognize these patients’ situation.

HPV Vaccine to Be Offered to All Children in England, Not Just Girls

2 months 3 weeks

(New Scientist) – Boys in England are to be offered the human papillomavirus (HPV) vaccine, 10 years after it was introduced for girls. The decision follows a recommendation from the Joint Committee on Vaccination and Immunisation (JCVI) last week, which stated that a gender-neutral programme to protect against the sexually transmitted virus would be cost-effective. The recommendation has already prompted the Scottish and Welsh governments to decide to extend vaccinations to boys.

Netanyahu’s U-Turn on Right to Surrogacy Sparks Mass LGBT Protests

2 months 3 weeks

(The Washington Post) – Waving rainbow flags and demanding equal rights, members of Israel’s LGBT community and their supporters rallied across the country Sunday, protesting the government’s refusal to amend a law that would have allowed gay couples to have children via surrogacy. Their anger was sparked by an apparent U-turn from Prime Minister Benjamin Netanyahu, who had committed to supporting a key change to existing surrogacy legislation but voted against an amendment when it was presented last week in the Knesset.

How Soon Is Soon Enough to Learn You Have Alzheimer’s?

2 months 3 weeks

(NPR) – The prospect of having Alzheimer’s can be so scary, and the current treatment options so few, that many people dismiss memory problems or other symptoms rather than investigate them, say Alzheimer’s specialists; it’s estimated that as many as half of all cases aren’t diagnosed. But that may soon change. Researchers are making progress in measuring beta-amyloid and other Alzheimer’s biomarkers in blood that might eventually be able to reliably, inexpensively and noninvasively identify the disease years before cognitive symptoms develop.

Chinese Leaders Order Probe Over Vaccine Scandal

2 months 3 weeks

(STAT News) – Chinese leaders are scrambling to shore up public confidence and oversight of the pharmaceutical industry after a rabies vaccine maker was found faking records, the latest in a slew of public health and safety scandals that have outraged Chinese parents. Premier Li Keqiang said in a statement Sunday that Changchun Changsheng Life Sciences Ltd., which is accused of fabricating production and inspection records, “violated a moral bottom line.” He pledged an immediate investigation of the company and to “resolutely crack down” on violations that endanger public safety.

In Lawsuit, Human Longevity Alleges That Craig Venter Stole Trade Secrets

2 months 3 weeks

(STAT News) – Human Longevity’s complaint accuses Venter of taking with him trade secrets on his company-issued laptop when he left the company in late May and using them to try to set up a competing business. It also accuses him of trying to poach Human Longevity’s employees, customers, and investors, despite having signed an agreement that he would not do so.

‘Alien’ Atacama Mummy Genetic Study Findings Raise Serious Concerns

2 months 3 weeks

(Newsweek) – In addition, the authors of the latest paper said the previous research also raised a number ethical concerns, especially given that the mummy is thought to be just a few decades old and the context in which they were discovered remained unclear. They argued, that the Stanford scientists did not follow the correct protocols for studying human remains, which are protected by law in Chile, like in many countries. Furthermore, the DNA extraction techniques that were used caused damage to Ata’s body.

10-Year-Old Somali Girl Dies Female Genital Mutilation

2 months 4 weeks

(ABC News) – A 10-year-old girl has bled to death after undergoing female genital mutilation in Somalia, an activist said, a rare confirmed death in the country with the world’s highest rate of the practice. The girl died in a hospital on Monday, two days after her mother took her to a traditional circumciser in a remote village outside Dhusamareb town in central Galmudug state, Hawa Aden Mohamed with the Galkayo Education Center for Peace and Development said in a statement.

Immigrant Shelters Drug Traumatized Teenagers Without Consent

2 months 4 weeks

(ProPublica) – Initially, staff described her as receptive and resilient. But as she was shuttled from one Texas shelter to another, she became increasingly depressed. Without consulting her grandfather, or her mother in El Salvador, shelter staff have prescribed numerous medications for her, including two psychotropic drugs whose labels warn of increased suicidal behavior in adolescents, according to court documents. Still languishing in a shelter after 18 months, the 17-year-old doesn’t want to take the medications, but she does anyway, because staff at one facility told her she wouldn’t be released until she is considered psychologically sound.

Long Waits to See Doctors in Puerto Rico Where Medical Needs Are Great Post-Maria

2 months 4 weeks

(Kaiser Health News) – Physicians are in short supply in Puerto Rico. From 2006 to 2016, the number of doctors on the island declined from 14,000 to 9,000, according the College of Physicians and Surgeons of Puerto Rico. And Hurricane Maria has helped fuel the exodus. Dr. José Cruz, a pediatrician with a practice in Ponce, said the island’s ongoing financial crisis and low payments from health insurers drove many physicians to seek work in the States.

Indigenous People ‘Attuned’ to Chronic Disease Risk

2 months 4 weeks

(SciDevNet) – Indigenous communities in northern Ecuador are concerned about rising rates of cancer in their ethnic group and “attuned” to the global phenomena behind the disease, researchers have found. A study carried out in two Kichwa communities located in the province of Imbabura, in the north of the country, found that villagers believe cancer rates are rising due to the use of chemical products, pollution, urbanization, lifestyle changes, as well as the increase of westernized diets and erosion of their culture.

Study Claiming Abortions Are ‘Reversible’ Retracted, Not Based on Science

2 months 4 weeks

(Newsweek) – A scientific journal withdrew a study that claimed women could halt the effects of an abortion pill after it failed to receive ethical approval. The study, initially published in April in the journal Issues in Law and Medicine, found that almost half of women who received a high dose of the hormone progesterone were able to successfully “reverse” the effects of mifepristone, one of two pills used to medically induce abortion. The study’s author, George Delgado, first presented his findings in a series of anecdotal journal entries in 2012 that prompted several conservative-leaning states to adopt legislation requiring doctors to inform women seeking abortions that the procedure can be halted.

Experts Say Recent ‘Alien’ Mummy Study Was Deeply Flawed and Unethical

2 months 4 weeks

(Gizmodo) – Earlier this year, scientists from Stanford University concluded that a strange skeleton known as the Atacama Mummy belonged to a human girl whose physical malformations were the result of several severe genetic mutations. A team of international experts is now questioning these findings, and accusing the scientists of breaching standard research ethics.

A Spike in Liver Disease Deaths Among Young Adults Fueled by Alcohol

2 months 4 weeks

(NPR) – The analysis revealed that deaths from liver-related illnesses have increased dramatically, and mortality in young people rose the fastest. Although these illnesses can be caused by several things including obesity and hepatitis C infection, the rise among young Americans was caused by alcohol consumption. The number of 25- to 34-year-olds who died annually from alcohol-related liver disease nearly tripled between 1999 and 2016, from 259 in 1999 to 767 in 2016, an average annual increase of around 10 percent.

Having 5 or More Babies May Increase Alzheimer’s Risk by 70%, Study Finds

2 months 4 weeks

(CNN) – Women who have given birth five or more times may be 70% more likely to develop Alzheimer’s later in life than those who have fewer births, according to a new study of more than 3,500 women in South Korea and Greece. Even women without dementia who had given birth five or more times scored lower on a commonly used cognitive test than those with fewer children. The study looked only at women older than 60; the average age of the women tested in both countries was 71.

Are ‘Breakthrough’ Drugs as Safe as Other FDA-Approved Medicines?

2 months 4 weeks

(CNN) – New research questions the quality of drugs given the “breakthrough therapy” designation by the US Food and Drug Administration. In late 2012, the FDA created this designation to speed the process for reviewing not-yet-approved experimental medicines intended to treat serious or life-threatening conditions. Commonly, the clinical trials supporting breakthrough drugs lack some of the scientifically rigorous features found in the research backing drugs that have not been granted that designation, a new study published in Tuesday in JAMA found.

A New Study Links Teens’ Screentime with Symptoms of ADHD

2 months 4 weeks

(Quartz) – American teenagers love their screens. Teens between 13 and 18 years old spend over six hours every day on smartphones, computers, tablets, and the like, well over the two-hour limit recommended by the American Academy of Pediatrics. Health experts have been sounding the alarm about the pitfalls of too much screen time—including increased risk of obesity, depression, anxiety, and sleep disorders. Now a study published Tuesday (July 17) in the Journal of the American Medical Association suggests that frequent use of digital media by adolescents may also increase their odds of developing symptoms of attention deficit/hyperactivity disorder, or ADHD.

Record Three in Five HIV-Carriers Now Have Access to Drugs: UN

2 months 4 weeks

(Medical Xpress) – Almost three in five people infected with HIV, or 21.7 million globally, took antiretroviral therapy in 2017—a new record for anti-AIDS drug access, the UN’s HIV/AIDS agency said Wednesday. There were 36.9 million people living with the immune system-attacking virus in 2017, of whom 15.2 million were not getting the drugs they need—the lowest number since the epidemic exploded, UNAIDS reported.

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