News from Bioethics.com

Drugmakers Master Rolling Out Their Own Generics to Stifle Competition

3 months 1 week

(Kaiser Health News) – When PDL BioPharma’s $40 million blood-pressure medicine faced the threat of a generic rival this year, the company pulled out a little-known strategy that critics say helps keep drugs expensive and competition weak. It launched its own generic version of Tekturna, a pill taken daily by thousands. PDL’s “authorized” copycat hit the market in March, stealing momentum from the new rival and protecting sales even though Tekturna’s patent ran out last year.

China Approves Ethics Advisory Group After CRISPR-Babies Scandal

3 months 1 week

(Nature) – China will establish a national committee to advise the government on research-ethics regulations. The decision comes less than a year after a Chinese scientist sparked an international outcry over claims that he had created the world’s first genome-edited babies. The country’s most powerful policymaking body, the Central Comprehensively Deepening Reforms Commission of the ruling Chinese Communist Party, headed by President Xi Jinping, approved at the end of last month a plan to form the committee. According to Chinese media, it will strengthen the coordination and implementation of a comprehensive and consistent system of ethics governance for science and technology.

Just One Season of Playing Football–Even Without a Concussion–Can Cause Brain Damage

3 months 1 week

(Science) – The familiar thudding soundtrack of football means nothing more to many fans than a well-executed game. But for neuroscience researchers, those sounds can signal something much darker: brain damage. Now, a new study shows playing just one season of college football can harm a player’s brain, even if they don’t receive a concussion.

Surrogacy Bill: The End of India’s $2.8 Billion ‘Rent-a-Womb’ Industry?

3 months 1 week

(Asia One) – The strict new bill being considered by lawmakers permits only Indian couples, married for at least five years and childless, to opt for surrogacy. It states that surrogate mothers must be “close relatives” of the recipients and carries strict criteria for surrogate mothers, genetic parents, fertility clinics, medical professionals, and the egg and sperm donors. But most importantly, it bans all commercial surrogacy and states that all women who agree to carry babies to delivery as surrogates must agree to do so for “altruistic” reasons. It also demands all couples applying for surrogate mothers to prove their infertility.

France Drafts Law to Extend IVF to Lesbians, Single Women

3 months 1 week

(Associated Press) – Single women and lesbians in France no longer would have to go abroad to get pregnant with a doctor’s help under a proposed law that would give them access to medically assisted reproduction at home for the first time. A bioethics law drafted by French President Emmanuel Macron’s government includes language to expand who is eligible for procedures such as artificial insemination and in vitro fertilization, or IVF. French law currently limits assisted reproduction to infertile heterosexual couples only.

When Lifesaving Drugs Are in Short Supply

3 months 1 week

(U.S. News & World Report) – Of all of the many late night “what ifs” I have wrestled with since my son’s diagnosis, a nationwide shortage of a generic drug to shrink and control brain tumors in children is not something I ever could have fathomed. Not in this country.  Yet in recent weeks, in oncology clinics and hospitals across the United States, patients, families and medical providers are having difficult conversations about whether there is enough Vinblastine to go around. On July 23, the Food and Drug Administration placed Vinblastine on its drug shortage list.

Superstar Athletes Popularize Unproven Stem Cell Procedures

3 months 1 week

(Kaiser Health News) – Baseball superstar Max Scherzer — whose back injury has prevented him from pitching for the Washington Nationals since he last played  on July 25 — is the latest in a long list of professional athletes to embrace unproven stem cell injections in an attempt to accelerate their recovery. But many doctors and ethicists worry that pro athletes — who have played a key role in popularizing stem cells — are misleading the public into thinking that the costly, controversial shots are an accepted, approved treatment.

Amid Rising Concern, Pay-to-Play Clinical Trials Are Drawing Federal Scrutiny

3 months 1 week

(STAT News) – In each case, there were “serious concerns about how ethical it was to charge people to participate in the research — and whether it was absolutely necessary,” said Russell-Einhorn, chief compliance officer for Advarra, the second-largest commercial IRB. These studies have caught the attention of federal regulators. The Food and Drug Administration recently asked a federal advisory committee to consider how the research community should think about such trials, an agency spokesperson confirmed. Members of that panel are now drafting recommendations on the issue. And the National Institutes of Health asked the committee to consider whether its existing resources to guide patients considering a clinical trial are adequate for scenarios in which they are being asked to pay, a spokesperson for that agency confirmed.

I Gave My DNA Away. Can I Get It Back?

3 months 1 week

(BBC) – But Tim Caulfield, research director at the health law institute at the University of Alberta, is not sure that people realise what they are signing up for when they answer the lengthy questionnaires about their health and heritage. “People need to look carefully at privacy statements because often these firms are partnering with the pharmaceutical industry and people should be aware that is happening,” he told the BBC. And while most of the firms – including 23andMe – operate on the basis that users can withdraw consent to use their genetic information at any time, it can be more complicated than that.

Scientists Went to China to Create Controversial Human-Monkey Embryos

3 months 1 week

(Gizmodo) – An international collaboration is claiming to have created hybridized human-monkey embryos in China. Disturbingly, the research could result in monkeys capable of producing human organs for transplants, leading to a host of ethical concerns. A researcher involved in the experiment, biologist Estrella Núñez from the Catholic University of Murcia (UCAM), confirmed the achievement to Spanish news site El País. The project is being led by Juan Carlos Izpisúa Belmonte, who runs a lab at the Salk Institute in the United States. 

The Vaccine Whisperers: Counselors Gently Engage New Parents Before Their Doubts Harden Into Certainty

3 months 1 week

(STAT News) – Vaccination counselors, the new employees were called. In 2017 and 2018, over 50 of them were stationed in more than a dozen of the province’s largest maternity wards, with plans to hire one or more at every last Québec hospital where mothers give birth by 2021. The counselors are themselves a kind of prophylaxis. Their job is to ask about parents’ worries long before anyone’s trying to vaccinate their kids at 2 months of age, to answer whatever questions come up — in other words, to inoculate against the misconceptions that might infect them online. Yet, unlike most medical interventions, this one unfolds entirely on the family’s terms.

Alzheimer’s Blood Test Could Predict Onset Up to 20 Years in Advance

3 months 2 weeks

(The Guardian) – A blood test that can detect signs of Alzheimer’s as much as 20 years before the disease begins to have a debilitating effect has been developed by researchers in the US. Scientists at the Washington University School of Medicine in St Louis in Missouri believe the test can identify changes in the brain suggestive of Alzheimer’s with 94% accuracy, while being much cheaper and simpler than a PET brain scan. The results of the study, which was published in the journal Neurology on Thursday, represent a potential breakthrough in the fight against the disease.

Scientists Are Making Human-Monkey Hybrids in China

3 months 2 weeks

(MIT Technology Review) – In a controversial first, a team of researchers have been creating embryos that are part human and part monkey, reports the Spanish daily El País. Daring biologist: According to the newspaper, the Spanish-born biologist Juan Carlos Izpisúa Belmonte, who operates a lab at the Salk Institute in California, has been working working with monkey researchers in China to perform the disturbing research. Their objective is to create “human-animal chimeras,” in this case monkey embryos to which human cells are added.

The Untold Story of the ‘Circle of Trust’ Behind the World’s First Gene-Edited Babies

3 months 2 weeks

(Science) – Because the Chinese government has revealed little and He is not talking, key questions about his actions are hard to answer. Many of his colleagues and confidants also ignored Science‘s requests for interviews. But Ryan Ferrell, a public relations specialist He hired, has cataloged five dozen people who were not part of the study but knew or suspected what He was doing before it became public. Ferrell calls it He’s circle of trust. That circle included leading scientists—among them a Nobel laureate—in China and the United States, business executives, an entrepreneur connected to venture capitalists, authors of the NASEM report, a controversial U.S. IVF specialist who discussed opening a gene-editing clinic with He, and at least one Chinese politician.

New Jersey Will Allow Terminally Ill Patients to End Their Lives Starting Today

3 months 2 weeks

(CNN) – Terminally ill adults in New Jersey will now be able to ask for medical help to end their lives. In April, Gov. Phil Murphy signed the Medical Aid in Dying for the Terminally Ill Act. It goes into effect Thursday.  It allows adults with a prognosis of six months or less to live to get a prescription for life-ending medication. Other jurisdictions that allow physician-assisted suicide are: California, Colorado, Oregon, Vermont, Washington, Hawaii, Montana and the District of Columbia. 

Bangladesh Struggles with Worst Outbreak of Dengue Fever

3 months 2 weeks

(Reuters) – Bangladesh is grappling with its worst outbreak of dengue fever, with hospitals packed with patients as the disease spreads rapidly in the densely-populated country. At least 14 people have died and more than 17,000 have come down with the virus so far this year, according to official figures, making it the deadliest year since the first recorded epidemic in 2000. More than 1,400 people have been diagnosed with dengue in the past 24 hours alone, the Health Ministry said on Thursday.

Kenyan Survivors: Cancer Is ‘National Disaster’

3 months 2 weeks

(BBC) – Cancer patients and carers are calling on Kenya’s government to declare the illness a “national disaster” and provide extra funds. Protesters took to the streets of the capital, Nairobi, in matching T-shirts that read Act on Cancer Today. They say long delays caused by a lack of accessible and affordable treatment mean many patients’ conditions worsen. Three recent high-profile deaths drew attention to cancer in Kenya which has 35 oncologists for 40 million people.This means there are more than 3,000 cancer cases for each oncologist in Kenya, compared to less than 150 in the US and China, according to the Journal of Global Oncology.

The Long Shadow of a CRISPR Scandal

3 months 2 weeks

(Science) – In the months after He Jiankui’s widely condemned embryo editing went public, Chinese researchers using the genome editor CRISPR reeled with embarrassment, outrage, and fear of unwarranted scrutiny and criticism of their own work. Some see He as a nobody in the country’s CRISPR community who sullied their whole field. “Many Chinese scientists got angry about [He],” says Deng Hongkui, a stem cell researcher at Peking University in Beijing. “Many of us got training in Western countries, and we know the international standards.”

China’s CRISPR Push in Animals Promises Better Meat, Novel Therapies, and Pig Organs for People

3 months 2 weeks

(Science) – Ji, Niu, and colleagues were the first to harness CRISPR in monkeys, as they reported in 2014, and they remain leaders in the field. They’ve built on that success, exploiting CRISPR’s speed and precision to create monkey models of muscular dystrophy, autism, and cancer. In a tie with developmental biologist Yang Hui and co-workers at Shanghai’s Institute of Neuroscience (a branch of the Chinese Academy of Sciences, CAS), they were first to use CRISPR in monkeys to introduce, or knock in, a gene—a particularly difficult feat that the two teams reported in back-to-back papers in 2018 in Cell Research. The team also collaborated with He Jiankui, well before the Chinese biophysicist created the first CRISPR-edited human babies.

‘Mosaic’ HIV Vaccine to Be Tested in Thousands of People Across the World

3 months 2 weeks

(Nature) – An experimental HIV vaccine that targets more strains of the virus than any other developed so far will start a late-stage clinical trial later this year. The ‘mosaic’ vaccine, which incorporates genetic material from HIV strains from around the world, also seems to have the longest-lasting effects of any others tested in people. Small trials of the mosaic vaccine in people showed that it prompted an immune response, such as the production of antibodies, against HIV. But starting in September, scientists will test it in thousands of people to assess whether the vaccine provides any protection against HIV infection. The phase III trial will test the vaccine in transgender individuals and in men who have sex with men across the Americas and Europe.

DeepMind AI Predicts Acute Loss of Kidney Function Two Days in Advance Study Shows

3 months 2 weeks

(STAT News) – One of the biggest challenges hospitals face is predicting when frail patients will decline into a life-threatening spiral. Subtle changes in health status get lost in a sea of data that is too vast for humans to effectively monitor. In a paper published Wednesday in the journal Nature, researchers at DeepMind describe a possible solution: A machine learning system capable of crunching hundreds of thousands of data points in electronic health records to alert physicians to an impending crisis long before it happens.

With Mini-Placentas and Mini-Brains, Scientists Try to Unravel the Roots of Psychiatric Disorders

3 months 2 weeks

(STAT News) – Biologist Jennifer Erwin of the Lieber Institute for Brain Development, however, has no intention of babying her organoids: the world’s first human placentas in a dish that were made from stem cells. Challenging as the half-millimeter-across organoids were to create, she intends to starve them of oxygen and douse them with stress hormones, among other assaults. It’s all for a good cause: to mimic pregnancy complications that raise the risk of brain development going off the rails, resulting in conditions including schizophrenia, autism, attention deficit hyperactivity disorder, and intellectual disability.

The World Health Organization Says No More Gene-Edited Babies

3 months 2 weeks

(Wired) – The world’s largest public health authority has weighed in with the most authoritative statement yet on the use of Crispr to alter the DNA of human babies. Eight months after a rogue Chinese scientist revealed he had secretly created the world’s first gene-edited children, the World Health Organization is asking countries to put a stop to any experiments that would lead to the births of more gene-edited humans. On Friday, the WHO’s Director-General put out a statement urging “that regulatory authorities in all countries should not allow any further work in this area until its implications have been properly considered.”  While stopping short of the all-out moratorium that many scientists called for in the hours and days after Chinese scientist He Jiankui revealed his controversial work in November, the WHO’s position is a strong rebuke of He’s work. But whether it will prove a powerful deterrent to any who would hope to follow in his footsteps remains to be seen.

Congo Officials Say Second Ebola Case Confirmed in City of Goma

3 months 2 weeks

(STAT News) – Officials in Congo on Tuesday said a second Ebola case had been confirmed in Goma, the city of more than 2 million people whose first confirmed case in this yearlong outbreak was reported earlier this month. There appeared to be no link between his case and the previous one in Goma, Jean-Jacques Muyembe, a local Ebola response coordinator, told reporters. He arrived on July 13 from a mining area in northeastern Congo’s Ituri province and started showing symptoms on July 22. He is now isolated at an Ebola treatment center. Goma is on Congo’s heavily traveled border with Rwanda and has an international airport. 

Artificial Intelligence Could Improve Health Care for All–Unless It Doesn’t

3 months 2 weeks

(Undark) – There is no shortage of optimism about AI in the medical community. But many also caution the hype surrounding AI has yet to be realized in real clinical settings. There are also different visions for how AI services could make the biggest impact. And it’s still unclear whether AI will improve the lives of patients or just the bottom line for Silicon Valley companies, health care organizations, and insurers.

Pages