News from Bioethics.com

A Woman Went Blind after Stem Cells Were Injected in Her Eyes

1 month 8 hours

(The Atlantic) – In March, eye doctors based primarily at the Bascom Palmer Eye Institute in Miami had published a widely covered report describing three eerily similar cases: Three elderly women with macular degeneration got stem cells derived from their own fat injected into their eyes at a different stem-cell clinic in Florida. The same thing happened: Their retinas became detached, and they went blind. The doctors ended up examining the 77-year-old woman too, which led to the recent case report describing her condition. And there are likely even more cases.

Desperate Quest for Herpes Cure Launched ‘Rogue’ Trial

1 month 8 hours

(Kaiser Health News) – A year later, their optimism has turned to uncertainty. Memories of kicking back in a Caribbean hotel during the trial have been overshadowed by the dread of side effects and renewed outbreaks. But they can’t turn to Halford, a Southern Illinois University professor. He died of cancer in June. They also can’t rely on his university, which shares in the vaccine’s patent but says it was unaware of the trial until after it was over. Because the FDA didn’t monitor the research, it can’t provide guidance. Indeed, there is little independent information about what was in the vaccine or even where it was manufactured, since Halford created it himself.

California Combats Deadly Hepatitis A Outbreak

1 month 9 hours

(CNN) – As firefighters continue to battle blazes across the state of California, public health officials are dealing with another ongoing crisis: one of the largest person-to-person hepatitis A outbreaks in the country since the development of a vaccine, more than two decades ago. An update provided Thursday by the California Department of Public Health (CDPH) raises the case count to 600. 395 people have been hospitalized and 19 have died since November 2016.

FDA Approves a Game-Changer Treatment for Blood Cancer

1 month 10 hours

(STAT News) – The Food and Drug Administration on Wednesday approved a promising new treatment for a particularly deadly form of cancer, bringing hope to desperate patients while rekindling a global conversation about the escalating cost of new therapies. The treatment, made by Gilead Sciences, is made by extracting patients’ white blood cells and re-engineering them to home in on tumors. Called a CAR-T, the one-time treatment has shown unprecedented results for patients with dire diagnoses.

Where the Opioids Go

1 month 10 hours

(The Atlantic) – The rate of death from opioid overdoses in the United States has more than doubled over the past decade. Amid a deluge of reports on the national crisis, it’s easy to lose sight of the fact that in much of the world many people die in preventable pain, without access to morphine for end-of-life care. This is the finding of a global commission published in The Lancet, which includes analysis of the global distribution of narcotics. The above map shows a relative distribution of how much of the need for opioids is met in various places.

6 in 10 Doctors Report Abusive Remarks from Patients, and Many Get Little Help Coping with Wounds

1 month 1 day

(STAT News) – Most doctors have absorbed racist, sexist, and other bigoted verbal remarks from patients under their care, according to a new national survey. And in interviews, physicians say these ugly incidents, while not frequent, can leave lasting scars. African-American doctors told STAT they had been called racial epithets and been asked to relinquish care for white patients by family members — and even colleagues. Asian-American physicians reported being demeaned with longstanding cultural and racist stereotypes, and female doctors being sexually harassed by patients during physical exams.

Ultra-Personal Therapy: Gene Tumor Boards Guide Cancer Care

1 month 1 day

(STAT News) – Doctors were just guessing a decade ago when they gave Alison Cairnes’s husband a new drug they hoped would shrink his lung tumors. Now she takes it too, but the choice was no guesswork. Sophisticated gene tests suggested it would fight her gastric cancer, and they were right. Cancer patients increasingly are having their care guided by gene tumor boards, a new version of the hospital panels that traditionally decided whether surgery, radiation, or chemotherapy would be best. These experts study the patient’s cancer genes and match treatments to mutations that seem to drive the disease.

Cancer Drug Prices Rising Far Faster Than Inflation

1 month 1 day

(Reuters) – The prices of injectable cancer drugs – even older medicines around since the 1990s – are increasing at a rate far higher than inflation, researchers report in the Journal of Clinical Oncology. The study, led by Dr. Daniel Goldstein of Emory University in Atlanta, looked at 24 injectable cancer drugs approved since 1996 and found the average increase was 25 percent over eight years. After inflation, the average increase was 18 percent.

A Spate of Deadly Disasters for the Elderly

1 month 2 days

(CNN) – Recent wildfires in California and hurricanes in Florida, Texas and Puerto Rico have put a spotlight on vulnerable seniors — including a number of deaths that authorities have said were preventable. “The bulk of them are in their 70s and 80s, so there is that commonality,” Sonoma County Sheriff Rob Giordano said of the first wildfire victims to be identified during a press conference Thursday. The majority were found in their homes, reduced to “ashes and bones,” Giordano said. Several were identified using medical implants, such as a hip replacement, with unique serial numbers.

‘Kidney for Sale’: Iran Has a Legal Market for the Organs, but the System Doesn’t Always Work

1 month 3 days

(Los Angeles Times) – In fact, Iran offers people a legal way to sell their kidneys — and is the only country in the world to do so. A government foundation registers buyers and sellers, matches them up and sets a fixed price of $4,600 per organ. Since 1993, doctors in Iran have performed more than 30,000 kidney transplants this way. But the system hasn’t always worked as it’s been billed. Sellers have learned that they can cut side deals to earn up to thousands more from well-off Iranians eager to bypass the roughly yearlong wait for a transplant under the government system, or foreigners barred from the national program. In recent years, doctors have been caught attempting to perform transplants for Saudis who obtained forged Iranian IDs.

Fertility: Why We Need a Registry for the Long-Term Risks of Egg Donors

1 month 3 days

(Newsweek) – The risks women face from becoming egg donors are unknown. And we can’t know the risks because long-term studies with a large population of women who have donated eggs have not been done. Now, one woman is calling for a national registry to track these unrecognized risks.

Genes for Skin Color Rebut Dated Notions of Race, Researchers Say

1 month 3 days

(New York Times) – “If you ask somebody on the street, ‘What are the main differences between races?,’ they’re going to say skin color,” said Sarah A. Tishkoff, a geneticist at the University of Pennsylvania. On Thursday, Dr. Tishkoff and her colleagues showed this to be a profound error. In the journal Science, the researchers published the first large-scale study of the genetics of skin color in Africans. The researchers pinpointed eight genetic variants in four narrow regions of the human genome that strongly influence pigmentation — some making skin darker, and others making it lighter.

An Anarchist Takes on the Drug Industry–by Teaching Patients to Make Their Own Meds

1 month 6 days

(STAT News) – The de facto leader behind the leaderless collective Four Thieves Vinegar, Laufer is now on to his next project: He’s developing a desktop lab and a recipe book meant to equip patients to cook up a range of medicines, including a homemade version of the expensive hepatitis C drug Sovaldi, on their kitchen counters. Health professionals have strenuously warned against DIY pharmaceuticals, but Laufer sees his work as a moral crusade against the patent laws and market forces that let drug companies price vital remedies out of reach for many patients.

Dementia Patient at Center of Spoon-Feeding Controversy Dies

1 month 6 days

(Kaiser Health News) -An Oregon woman with Alzheimer’s disease, whose husband claimed she was kept alive with spoon-feeding against her written wishes, has died. Nora Harris, 64, died early Wednesday at the Fern Gardens senior care center in Medford, Ore. Her husband, Bill Harris, said the death marks the end of an eight-year battle with the progressive, debilitating disease, which included an unsuccessful court fight to withdraw all food and liquid.

Sweden Won’t Prosecute Italian Stem Cell Scientist

1 month 6 days

(San Francisco Chronicle) – Swedish prosecutors have abandoned an investigation against a disgraced Italian stem cell scientist suspected of involuntary manslaughter in connection with three patients who died after windpipe transplants. Prosecutor Jennie Nordin said it can’t be proven that Dr. Paolo Macchiarini would be guilty of either causing another’s death or causing bodily harm, so he is no longer a suspect.

FDA Advisers Back Gene Therapy for Rare form of Blindness

1 month 6 days

(Nature) – Advisers to the US Food and Drug Administration (FDA) have paved the way for the agency’s first approval of a gene therapy to treat a disease caused by a genetic mutation. On 12 October, a panel of external experts unanimously voted that the benefits of the therapy, which treats a form of hereditary blindness, outweigh its risks. The FDA is not required to follow the guidance of its advisers, but it often does. A final decision on the treatment, called voretigene neparvovec (Luxturna), is expected by 12 January.

To Accelerate New Cancer Treatments, NIH Will Team Up with Pharma on Immunotherapy Research

1 month 1 week

(STAT News) – The National Institutes of Health on Thursday announced a $215 million public-private partnership with 11 pharmaceutical companies in what the agency bills as a significant next step in its cancer moonshot. The Partnership for Accelerating Cancer Therapies, or PACT, is a five-year agreement to push ahead with research that seeks to “identify, develop and validate robust biomarkers — standardized biological markers of disease and treatment response — to advance new immunotherapy treatments that harness the immune system to attack cancer,” the agency said.

Puerto Rico Investigates Post-Hurricane Disease Outbreak

1 month 1 week

(STAT News) – Four deaths in Hurricane Maria’s aftermath are being investigated as possible cases of a disease spread by animals’ urine, Puerto Rico’s governor said Wednesday amid concerns about islanders’ exposure to contaminated water. A total of 10 people have come down with suspected cases of leptospirosis, Gov. Ricardo Rossello said at a news conference. On a U.S. territory where a third of customers remain without running water three weeks after the hurricane, some became ill after turning to local streams to relieve their thirst.

The Rise and Fall and Rise again of 23andMe

1 month 1 week

(Nature) – 23andme has always been the most visible face of direct-to-consumer genetic testing, and it is more formidable now than ever before. In September, the company announced that it had raised US$250 million: more than the total amount of capital raised by the company since its inception. Investors estimate that it is worth more than $1 billion, making it a ‘unicorn’ in Silicon Valley parlance — a rare and valuable thing to behold. But for scientists, 23andme’s real worth is in its data. With more than 2 million customers, the company hosts by far the largest collection of gene-linked health data anywhere. It has racked up 80 publications, signed more than 20 partnerships with pharmaceutical firms and started a therapeutics division of its own.

Gene Expression Study Raises Thorny Ethical Issues

1 month 1 week

(Nature) – Ronald’s myriad tissues, and those of almost 1,000 other anonymous deceased donors, are now the basis of a first-of-its-kind database. Supported by the US National Institutes of Health, the US$150-million Genotype-Tissue Expression (GTEx) project is amassing data about gene sequences and activity, and other information, across 44 types of tissue, from blood vessels to 10 different brain regions.  “It’s creating a ‘Google Maps’ of the body,” says Kristin Ardlie, a geneticist at the Broad Institute of MIT and Harvard in Cambridge, Massachusetts, who is part of the project’s data-analysis team. It routinely releases new data, which are freely available to qualified researchers.

Should You Be Allowed to Sell Your Kidney?

1 month 1 week

(Gizmodo) – But there are rare, new alternatives of doctors incentivizing altruistic donations. One such promising idea is UCLA’s new “take-a-kidney-leave-a-kidney” voucher program. It solves the problem of what doctors are calling “chronological incompatibility”—friends and family who would be willing to provide kidneys to relatives who might not need one until after the donor is dead or available to donate. Now they can pay their kidney forward and get a voucher for their recipient, who will be able to move up the transplant list. So far, the program has spurred at least 25 donations. Yet, 25 donations pales when you consider that 13 Americans died today, and every day, waiting for a kidney, according to the National Kidney Foundation.

Doctors Get Their Own Second Opinions

1 month 1 week

(The Atlantic) – Human Dx might help doctors confirm their suspected diagnoses or think of things to rule out. At Mary’s Center, one man came in complaining of headaches and nausea, and the Human Dx physicians suggested a blood test called an ESR. Another time, Nundy used it to confirm a suspected case of rheumatoid arthritis before putting a low-income patient on a heavy-duty course of medications. Experienced doctors use Human Dx for their most difficult cases, and newer providers use it to hone their skills. Johns Hopkins Hospital and other teaching hospitals are now using it to train medical residents.

Fertility MOT Tests ‘A Waste of Money’

1 month 1 week

(BBC) – Fertility tests marketed at women worried they have left it too late to have a baby, can be a “waste of money”.  Ovarian reserve tests, which can cost £100 or more, measure hormones in blood to give an idea of how many eggs a woman has. Latest research in the Journal of the American Medical Association found the tests did not predict a woman’s chance of conceiving, however. Women must be told this, experts say. The tests were originally developed by IVF clinics to predict how a woman having fertility treatment might respond to the drugs used to stimulate the ovaries to produce eggs.  But some companies have been marketing them to women as a fertility MOT.

Seeing Hope: FDA Panel Considers Gene Therapy for Blindness

1 month 1 week

(ABC News) – On Thursday, U.S. Food and Drug Administration advisers will consider whether to recommend approval of a gene therapy that improved vision for these three youths and some others with hereditary blindness. It would be the first gene therapy in the U.S. for an inherited disease, and the first in which a corrective gene is given directly to a patient. Only one gene therapy is sold in the U.S. now, a cancer treatment approved in August that engineers patients’ blood cells in the lab.

More than 2,000 Canadians Have Died with Medical Assistance Since Legalization

1 month 1 week

(CBC News) – More than 2,000 Canadians have ended their lives legally with the help of a doctor, and most of them were suffering from terminal cancer. According to the latest report from Health Canada, there were 1,982 medically assisted deaths in the one-year period after it became legal in June 2016. There have been another 167 in Quebec since it was legalized in that province in December 2015, the report said. The total has been rising faster, with 803 assisted deaths in the first six months after it became legal nationally and 1,179 in the following six months from January to June 2017.

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