News from Bioethics.com

Unsafe Ocular Stem Cell Treatments Prevalent

2 weeks 1 day

(Medscape) – Experimental stem cell therapies for eye conditions are being offered at dozens of unregulated clinics in the United States, and some of these procedures are harmful, researchers report. Clinicians should warn their patients against clinics that provide stem cell treatments but offer no other ophthalmologic services, said Ajay Kuriyan, MD, from the University of Rochester Medical Center in New York.

Big Pharma Would Like Your DNA

2 weeks 1 day

(The Atlantic) – 23andMe has always planned to sell access to its customers’ DNA—a fact it has not exactly kept secret. When the company’s DNA-testing service launched in 2007, Wired touted its quest to amass a “treasure trove of data … to drive research forward” as a “key part of the 23andMe business plan.” Co-founders Anne Wojcicki and Linda Avey outright told the San Francisco Chronicle that selling kits was only the first step. “The long game here is not to make money selling kits, although the kits are essential to get the base level data,” a 23andMe board member said to Fast Company in 2013. “Once you have the data, [the company] does actually become the Google of personalized health care.”

11 Years After Child’s Death, SC Supreme Court Decides Genetic Lab Is a ‘Health Care Provider’

2 weeks 1 day

(The Post and Courier) – Ultimately, his health care providers turned to genetic testing to reveal the cause of Christian’s illness. A lawsuit filed by his mother, Amy Williams, alleges Athena Diagnostics, which processed her son’s blood sample, misdiagnosed his DNA mutation, thus prompting his doctors to recommend the wrong course of treatment. The medication that Christian continued to take likely made him worse, the lawsuit contends. Christian died in 2008 before his third birthday following a traumatic seizure.

Artificial Hip Maker Demands Retraction of a Paper Calling Its Research ‘Grave Fraudulence’

2 weeks 4 days

(STAT News) – J&J/DePuy violated the study protocol and manipulated data; consented participants in violation of standards protecting human subjects; and did not secure Institutional Review Board approval for all study sites,” they wrote about a clinical trial of the companies’ Pinnacle metal-on-metal hip replacement system, which was taken off the market in 2013 after many patients had to have the artificial hips removed. The study, they argued based on an analysis of internal company documents, was nothing more than a “seeding study,” designed to market the device to doctors rather than present a test of its safety or efficacy.

Hospitals Know How to Protect Mothers. They Just Aren’t Doing It.

2 weeks 4 days

(USA Today) – Every year, thousands of women suffer life-altering injuries or die during childbirth because hospitals and medical workers skip safety practices known to head off disaster, a USA TODAY investigation has found. Doctors and nurses should be weighing bloody pads to track blood loss so they recognize the danger sooner. They should be giving medication within an hour of spotting dangerously high blood pressure to fend off strokes. These are not complicated procedures requiring expensive technology. They are among basic tasks that experts have recommended for years because they can save mothers’ lives.

Why Did 11 Babies Die in a Generic Viagra Trial?

2 weeks 4 days

(The Atlantic) – The story goes that Viagra began as a drug for chest pains. It didn’t work very well. But men in those clinical trials noticed a curious side effect of erections—and lo, a blockbuster drug was born. Since then, the uses of Viagra, or its non-brand counterpart sildenafil, have continued to morph. Clinicaltrials[dot]gov currently lists 60 planned and ongoing sildenafil trials, and it’s already a common treatment for high blood pressure in the lungs. Until this week, one of the many trials in progress was for pregnant women in the Netherlands whose babies grew too slowly in the womb. But after 11 of those babies died from lung problems after birth, the trial was swiftly terminated, as was a similar one in Canada.

Dying Man Openly Opposed Assisted Suicide in His Last Days

2 weeks 4 days

(San Francisco Gate) – In December, J.J., 36, died of the disease, but his family said he spent his last days opposing assisted death and, instead, advocating for better end-of-life care. His wife said he told her that if he had had the lethal dose of medication on his bedside during his darkest of days, he might have used it and then missed out on three more years with his family. He said he didn’t want that to happen to others.

Scientists Fine Possible Method for Repair of Cell Damage from MS

2 weeks 4 days

(UPI) – Scientists have determined how drugs can repair damaged brain cells that cause disability in people with multiple sclerosis, and possibly other degenerative neurological diseases. In separate labs at Case Western Reserve University School of Medicine, the researchers gained new insights into how the body makes myelin, which is a fatty substance serving as a protective sheath that surrounds nerve cells and helps transmit electrical impulses in the brain and spinal cord.

Did a Study of Indonesian People Who Spend Most of Their Days Under Water Violate Ethical Rules?

2 weeks 4 days

(Science) – In April, a paper showing why Indonesia’s Bajau people are such great divers drew worldwide attention as a striking example of recent human evolution. But the study, published in Cell, has created a different kind of stir in Indonesia, where some say it is an example of “helicopter research” carried out by scientists from rich countries with little consideration for local regulations and needs. “Too many mistakes were made here,” says geneticist Herawati Sudoyo, who heads the Eijkman Institute for Molecular Biology in Jakarta. Indonesian officials say the research team failed to obtain ethical approval from a local review board and took DNA samples out of the country without the proper paperwork.

Can Gene Therapy Halt Diseases in Babies Before They’re Even Born?

2 weeks 4 days

(STAT News) – Gene therapies — in which a corrective gene hitches a ride on a virus into a patient’s cells — are being tested as potential cures or treatments for sickle cell, Duchenne muscular dystrophy, and a range of other diseases. Some patients have already been treated with a gene therapy for an inherited form of blindness, the first to be approved in the U.S. Now, imagine the virus-gene rig slipping into a pregnant woman’s womb, where it would reach the fetus and start remedying a disease before the baby is even born. That kind of procedure remains an untested goal for now — one whose feasibility has been debated by scientists for years. But advances in fetal gene therapies in animal models have raised the real possibility that clinical trials may be soon at hand.

Eleven Babies Die after Dutch Women Given Viagra-Like Drug in Trial

2 weeks 5 days

(The Guardian) – The death of 11 babies born to women who were given sildenafil during a drug trial has led to the termination of the experiment – and an anxious wait for other mothers involved. Sildenafil is sold by Pfizer as Viagra, but the pills used in the study were not ones produced by the pharmaceutical giant. The trial was designed to test whether the medication could help boost babies’ growth in the womb. The research was carried out at 10 hospitals across the Netherlands and involved women whose placentas had been underperforming.

Controversial US Ketamine Trial Sparks Ethics Debate

2 weeks 5 days

(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 weeks 5 days

(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 weeks 6 days

(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 weeks 6 days

(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 weeks 6 days

(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 weeks 6 days

(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

3 weeks 7 hours

(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

3 weeks 7 hours

(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

3 weeks 8 hours

(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

3 weeks 8 hours

(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?

3 weeks 8 hours

(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

3 weeks 1 day

(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

3 weeks 1 day

(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

3 weeks 1 day

(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.

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