News from Bioethics.com

After the Storms, Restoring Puerto Rico’s already Weak Electrical Grid Is FDA’s Top Priority

3 months 1 day

(STAT News) – The Food and Drug Administration’s biggest concern in Puerto Rico is access to electricity, Commissioner Scott Gottlieb said at a congressional hearing Tuesday morning. “If [drug and device manufacturing plants] don’t return to the grid by the end of this year, we’re concerned we could face multiple potential shortages,” Gottlieb said. He added that the concern could be mitigated if companies shift more of their manufacturing operations off the island. The FDA has not announced any shortages directly related to Hurricane Maria, but Gottlieb said that the agency is keeping close watch on 30 different drugs and 50 types of devices.

Womb with a View: Surgeons Remove Uterus from Mother in Groundbreaking Operation on Spina Bifida Foetus

3 months 1 day

(The Telegraph) – It might look like a glowing egg from an alien world, but this red ovoid is actually human womb containing a baby, removed from its mother before birth, in a groundbreaking operation. Doctors in the US have been pioneering an astonishing new treatment for spina bifida in which the baby is operated on before birth.

Breast Cancer Genetics Revealed: 72 New Mutations Discovered in Global Study

3 months 1 day

(CNN) – The genetic causes of breast cancer just got clearer.  Researchers from 300 institutions around the world combined forces to discover 72 previously unknown gene mutations that lead to the development of breast cancer. Two studies describing their work published Monday in the journals Nature and Nature Genetics. The teams found that 65 of the newly identified genetic variants are common among women with breast cancer.

Britain Backs GSK’s Gene Therapy for ‘Bubble Boy’ Syndrome

3 months 1 day

(Reuters) – GlaxoSmithKline’s gene therapy for the so-called “bubble boy” disease was approved by Britain’s healthcare cost watchdog NICE, despite a price tag of almost 600,000 euros ($700,000). Gene therapy is designed to deliver a one-off cure for the patient and drugmakers are typically asking a hefty price that is comparable to the combined costs of alternative life-long treatment.

A Baby with a Disease Gene or No Baby at All: Genetic Testing of Embryos Creates an Ethical Morass

3 months 1 day

(STAT News) – Jessie and Samantha’s story speaks to an emerging ethical morass in the field of reproductive medicine: what to do when patients seeking to get pregnant select embryos with DNA that could lead to a disease or disability. Should clinicians’ desire to help their patients have children override concerns about possibly doing harm to those children? And what about cases in which patients — like Samantha and Jessie — end up with only one viable embryo through in vitro fertilization?

DNA Scan for Infants Raise Questions of Privacy and Discrimination

3 months 1 day

(CBS) – Genetic counselors in Boston are offering new parents a controversial peek at their baby’s future health. It’s part of a landmark study that could lead to gene scans for all infants at birth. By law, every newborn in America gets a blood test for about 30 conditions including cystic fibrosis and sickle cell anemia. A trial underway at Brigham and Women’s Hospital uses genomic sequencing to screen for about 1,800 conditions, including some cancers.

WHO Cancels Robert Mugabe Goodwill Ambassador Role

3 months 2 days

(BBC) – The World Health Organization has revoked the appointment of Zimbabwe’s Robert Mugabe as a goodwill ambassador following a widespread outcry. “I have listened carefully to all who have expressed their concerns,” WHO head Tedros Adhanom Ghebreyesus said in a statement. He had previously praised Zimbabwe for its commitment to public health. But critics pointed out that Zimbabwe’s healthcare system had collapsed in recent years.

Robert Mugabe Is Appointed a WHO Goodwill Ambassador, Stunning Critics

3 months 2 days

(STAT News) – The new head of the World Health Organization has named Zimbabwean President Robert Mugabe a goodwill ambassador for the agency, a move that has startled and dismayed public health experts. The WHO director-general, Tedros Adhanom Ghebreyesus, announced the controversial appointment on Wednesday in a speech at a global conference on noncommunicable diseases in Montevideo, Uruguay. Tedros, as he is known, described himself as “honored” that Mugabe — whose government has repressed protesters and the political opposition, has been accused of rigging elections, and has been implicated in widespread human rights violations — had agreed to serve as a goodwill ambassador on noncommunicable diseases for Africa.

FDA Teams with Medical Companies in Puerto Rico to Tackle Shortages

3 months 5 days

(Reuters) – The head of the U.S. Food and Drug Administration said the agency was working with several pharmaceutical and medical device companies in Puerto Rico to prevent shortages of medical products in the United States as it joins a massive effort to help rebuild the island that was ravaged by Hurricane Maria. Drugmakers are working to get facilities fully online after the storm slammed into the Caribbean island on Sept. 20, knocking out electricity and causing widespread damage to homes and infrastructure.

Link between Adolescent Pot Smoking and Psychosis Strengthens

3 months 5 days

(Scientific American) – Society’s embrace of cannabis to treat nausea, pain and other conditions proceeds apace with the drive to legalize the plant for recreational use. Pot’s seemingly innocuous side effects have helped clear a path toward making it a legal cash crop, with all of the marketing glitz brought to other consumer products. But that clean bill of health only goes so far. Marijuana’s potentially detrimental impact on the developing brains of adolescents remains a key focus of research—particularly because of the possibility teenage users could go on to face a higher risk of psychosis.

U.S. Must Allow Undocumented 17-Year-Old to Have Abortion, Judge Says

3 months 5 days

(New York Times) – A federal judge on Wednesday ordered top United States government officials to allow a pregnant 17-year-old immigrant to get an abortion — the first ruling in a case that could eventually grow to include hundreds of other undocumented minors who seek access to an abortion while in federal custody.

Ethical Concerns Arise for Head of Controversial Stem Cell Clinic

3 months 5 days

(Retraction Watch) – Journals are raising ethical concerns about the research of a doctor who offers controversial embryonic stem cell treatments. Two journals have issued expressions of concern for three papers by Geeta Shroff, who was the subject of a 2012 CNN investigative documentary. All cite ethical concerns; one mentions the potential link between the procedure the authors describe and a risk of forming teratomas, a type of tumor. Shroff has objected to all three notices.

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

3 months 6 days

(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

3 months 6 days

(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

3 months 6 days

(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

3 months 6 days

(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

3 months 6 days

(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

3 months 1 week

(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

3 months 1 week

(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

3 months 1 week

(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

3 months 1 week

(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

3 months 1 week

(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

3 months 1 week

(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

3 months 1 week

(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

3 months 1 week

(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.

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