News from Bioethics.com

FDA to End Program That Hid Millions of Reports on Faulty Medical Devices

2 weeks 5 days

(Kaiser Health News) – The Food and Drug Administration announced it is shutting down its controversial “alternative summary reporting” program and ending its decades-long practice of allowing medical device makers to conceal millions of reports of harm and malfunctions from the general public. The agency said it will open past records to the public within weeks.
A Kaiser Health News investigation in March revealed that the obscure program was vast, collecting 1.1 million reports since 2016.

Lost Fertility Clinic Embryos Weren’t Living Persons, Ohio Appellate Court Rules

2 weeks 6 days

(CNN) – Frozen embryos are not living persons, an appellate court in Ohio affirmed Thursday. The ruling is the latest development in a case brought by a couple who lost three embryos in a fertility clinic storage tank malfunction last year. Wendy and Rick Penniman of suburban Cleveland were among the more than 950 families affected by the tank failure in March 2018 at Cleveland’s University Hospitals Fertility Clinic. The malfunction caused the temperature to rise, destroying more than 4,000 eggs and embryos.

A Rising Trend in Cancer Care Targets Physical, Existential Threats Patients Confront

2 weeks 6 days

(The Washington Post) – Often called palliative care or integrative medicine, the comprehensive approach focuses on patients’ emotional needs and physical symptoms in addition to treating the disease. In 2016, 1,831 U.S. hospitals — about three-quarters — had a palliative care program, compared to less than one-quarter in 2000, according to the Center to Advance Palliative Care. While palliative care is often associated with terminal cases — and often confused with end-of-life hospice care — it’s actually designed for patients suffering from many types of serious illnesses, regardless of how long they’re expected to live.

Belgium Passes Law to Penalize Medical Tourism for Organ Transplants

2 weeks 6 days

(The Epoch Times) – Belgium’s primary legislative body passed a new bill on April 25 that would punish all parties involved in the buying and selling of human organs for commercial purposes. Violators face up to 20 years imprisonment with a 1.2 million euros ($1.35 million) fine. This law is not only effective within Belgium; it prohibits all Belgian citizens from procuring organs, regardless of where the transaction took place—effectively banning medical tourism for organ transplants.

End to AIDS in Sight as Huge Study Finds Drugs Stop HIV Transmission

3 weeks 2 days

(The Guardian) – An end to the Aids epidemic could be in sight after a landmark study found men whose HIV infection was fully suppressed by antiretroviral drugs had no chance of infecting their partner. The success of the medicine means that if everyone with HIV were fully treated, there would be no further infections.

Congo Ebola Death Toll Nears 1,000, New Vaccine Planned: WHO

3 weeks 2 days

(Reuters) – The World Health Organization said on Friday it feared continued “intense transmission” of Ebola virus in the Democratic Republic of Congo, where deaths from a nine-month-old epidemic stood at 994 and were expected to exceed 1,000 within hours. The WHO plans to expand vaccination with an unlicensed new Ebola vaccine made by Johnson & Johnson, in addition to a Merck vaccine already being used, said Dr. Michael Ryan, executive director of WHO’s Health Emergencies Programme.

First U.S. Use of CRISPR to Directly Target Cancer Will Seek Go-Ahead from Regulators

3 weeks 3 days

(STAT News) – The Gene Editing Institute at Christiana Care Health System, a nonprofit, private community (as opposed to academic) medical system headquartered in Delaware, is preparing to seek regulatory approval for a much bolder CRISPR cancer study. If it receives the OK from the Food and Drug Administration, which it plans to request in the next few months, it would recruit six to 10 patients with late stage non-small-cell lung cancer and test whether using CRISPR to disable a particular gene would allow standard chemotherapy to work better and longer, ideally buying patients a little more time.

Amid America’s Opioid Crisis, Deaths from Stimulants Are Steadily Rising

3 weeks 3 days

(CNN) – Headlines about America’s drug crisis have long centered on opioids such as heroin and fentanyl. But a new report from the US Centers for Disease Control and Prevention paints a more complicated picture of the drug crisis. Overdose deaths involving cocaine and psychostimulants such as methamphetamines, MDMA, methylphenidate (commonly sold as Ritalin) and caffeine have also been steadily rising. In 2017, there were 23,139 overdose deaths involving these drugs, making up nearly a third of the 70,237 fatal overdoses that year, according to Thursday’s report.

Cannabis Used in US Research Differs Genetically to the Varieties People Smoke

3 weeks 3 days

(Nature) – The cannabis that’s used for research in the United States is genetically different to the stuff people are smoking, says a recent study. The finding suggests that research investigating the plant’s biological effects might not completely replicate the experience of people using commercially available strains ? something researchers have long suspected.

On Cyclone-Shattered Island in Mozambique, Shock and Debris

3 weeks 3 days

(ABC News) – Cyclone Kenneth in northern Mozambique ripped the island of Ibo apart. Nearly a week after the storm roared in, Associated Press journalists found widespread devastation. The aerial approach to the island showed communities flattened. The overwhelming majority of homes had their roofs peeled away. Contaminated wells have made safe drinking water an immediate health concern. Mozambique’s government on Thursday night reported more than a dozen cases of cholera, a disease caused by contaminated food or water, elsewhere in Cabo Delgado province.

‘The World Has Never Seen Anything Like This’: WHO Chief on Battling Ebola in a War Zone

3 weeks 3 days

(Nature) – The head of the World Health Organization, Tedros Adhanom Ghebreyesus, is distraught. The Ebola outbreak in the Democratic Republic of the Congo (DRC) continues to worsen, and his front-line responders are under attack. On 4 May, Ghebreyesus will attend the funeral of a 41-year old epidemiologist, Richard Mouzoko, who was shot dead in the city of Butembo on 19 April by men who reportedly shouted, “Ebola doesn’t exist!” Dozens of other Ebola responders have been assaulted in recent months in the northeastern DRC — a region that has been wracked by conflict for decades.

Fentanyl Executive John Kapoor’s Conviction Is Good News for Holding Corporations Accountable

3 weeks 3 days

(STAT News) – The feds brought down their fentanyl billionaire — make that former billionaire. John Kapoor, the founder, former chairman, and former chief executive of Insys Therapeutics, has been convicted of a racketeering conspiracy that involved bribing doctors and lying to insurance companies to boost sales of Subsys, Insys’ powerful opioid drug. Four other Insys executives were also convicted. The conviction is important because all too often when powerful executives orchestrate marketing maneuvers that put patients at risk, they go unpunished even as their companies pay fines or their lieutenants are prosecuted.

Alabama Lawmakers Move to Outlaw Abortion in Challenge to Roe v. Wade

3 weeks 3 days

(NPR) – In what would likely become the most restrictive abortion ban in the country, the Alabama House Tuesday passed a bill that would make it a crime for doctors to perform abortions at any stage of a pregnancy, unless a woman’s life is threatened. The legislation is part of a broader anti-abortion strategy to prompt the U.S. Supreme Court to reconsider the right to abortion.

Ebola Outbreak in Congo Hits Record for Confirmed Cases in Single Day

3 weeks 4 days

(CNN) – The Ebola outbreak in the Democratic Republic of Congo has reached a grim milestone, with 27 new cases confirmed in a single day — a record for the current outbreak. The outbreak, which is the second deadliest in history, has proved difficult to bring under control because of community mistrust and violent attacks on health care workers. The World Health Organization said 27 new confirmed cases had been reported Sunday, the most in a single day since the outbreak started in August.

Experimental Treatment Could Be ‘Game-Changing’ for Genetic ALS, Experts Say

3 weeks 4 days

(CNN) – An experimental treatment for the rapidly progressive disease ALS, or amyotrophic lateral sclerosis, has been called potentially “game-changing.” The treatment, called tofersen, was found to slow the decline of muscular function associated with a genetic form of ALS in a study to be presented next weekat the annual meeting of the American Academy of Neurology.

New Type of Dementia Identified

3 weeks 5 days

(BBC) – Millions of elderly people have a form of dementia that has been misdiagnosed as Alzheimer’s disease, according to researchers. One expert called it the most important dementia finding in years. The condition, limbic-predominant age-related TDP-43 encephalopathy, or Late, shares similar symptoms to Alzheimer’s, but it is a distinct disease, the journal Brain reports. It may partly explain why finding a dementia cure has failed so far.

An Experimental Test May Help Confirm Cases of Chronic Fatigue Syndrome

3 weeks 5 days

(STAT News) – A new device could offer an effective way of diagnosing myalgic encephalomyelitis, also known as chronic fatigue syndrome. People with the disease experience symptoms such as fatigue, sleep abnormalities, and pain, but it’s been notoriously hard to diagnose. Stanford’s Ron Davis first got the idea for the device back in 2015 while attending an event at the Institute of Medicine where panelists debated whether the disease was a real condition, he recalled.

In a World First, Drone Delivers Kidney for Transplant

3 weeks 5 days

(U.S. News & World Report) – In what researchers are calling a groundbreaking achievement, an unmanned drone delivered a new kidney for a 44-year-old Baltimore woman. On April 19, the aircraft delivered the donor kidney that was successfully transplanted by a surgical team at the University of Maryland Medical Center in Baltimore. The patient was discharged April 23. Before the operation, she had undergone eight years of dialysis because of kidney failure.

Measles Cases Count in the U.S. Tops 700 This Year, as Health Officials Urge Vaccinations

3 weeks 6 days

(STAT News) – T he number of U.S. measles cases has topped 700 already this year, the Centers for Disease Control and Prevention reported Monday, adding that nearly 70 children have been hospitalized. This year’s surge in measles cases — the worst year for the disease since 1994 — has sent 66 children to the hospital, newly released data show. Twenty-four have developed pneumonia.

Researcher Raises Ethical Concerns Over Chinese Experiment to Make Monkeys More Human

3 weeks 6 days

(News Corp Australian Network) – A computer scientist who is credited as a researcher on a Chinese medical experiment that saw monkey brains implanted with human genes to make them more human, has slammed the project as ethically unacceptable. Dr Martyn Styner, an associate professor at the University of North Carolina, has distanced himself from the experiment after the group of Chinese scientists who led it became the target of a medical ethics debate. Dr Styner argues the knowledge gained from messing with monkey brains in this way was not enough to go through with it.

Surrogacy: Why the World Needs Rules for ‘Selling’ Babies

1 month 22 hours

(BBC) – Surrogacy comes in two forms – gestational, where the surrogate mother is implanted with an egg and sperm; and traditional surrogacy, where the surrogate’s own egg is used. The procedure can bring with it great advantages, especially for those who can’t have children naturally, by allowing individuals and couples to have their “own” child, without going through a long and restrictive adoption process. In the majority of cases, these procedures go smoothly. But surrogacy’s soaring popularity has come at a human cost and stories of potential mistreatment have hit the headlines several times in recent years.

‘I Helped Test a Wonder Drug–Then I Was Denied It’

1 month 22 hours

(BBC) – Because of rare illness, Louise Moorhouse is on a special diet of pills or foul-tasting shakes. There’s a drug that would allow her to eat like anyone else – she took it for three years during a clinical trial. But the NHS won’t pay for it, reports the BBC’s Deborah Cohen – and the drug company stopped giving it to her once the trial was over.

Pakistan’s Anti-Vaccination Movement Leads to String of Deadly Attacks

1 month 22 hours

(CNN) – A string of deadly attacks in Pakistan targeting healthcare workers has sparked fears that the spread of misinformation is fueling a resurgence of violence against those attempting to rid the country of polio. Attacks were reported on Monday in Bannu, Wednesday in Buner and Thursday in Quetta. One polio vaccination worker and two policemen have been killed. Public health experts say there is concern that these attacks are exacerbating what is already one of the world’s most intractable public health threats.

Cannabis Addiction Linked to Genetic Variants

1 month 22 hours

(GEN) – A study in human volunteers has found that some individuals may be genetically more predisposed to cannabis addiction than others. The research, headed by a team at University College London (UCL), linked specific variants in the cannabinoid receptor 1 (CNR1) gene and in the fatty acid amide hydrolase (FAAH) gene with behavioral measures of addiction predisposition, or endophenotypes, which are typical of cannabis use disorders (CUD).

First Proven Malaria Vaccine Rolled Out in Africa–But Doubts Linger

1 month 1 day

(Nature) – When health workers in Malawi began rolling out the first vaccine proven to protect against malaria, it was a moment 32 years — and more than US$700 million — in the making. The country began giving the vaccine, called RTS,S, to children under age 2 on 23 April. Soon Ghana and Kenya will join in, as part of a large-scale pilot programme backed by the World Health Organization (WHO). The effort could immunize more than one million children by 2023 — a welcome boost in the fight against malaria, which kills an average of 1,200 people worldwide per day. The vast majority are children in Africa.

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