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A New Front in the War over Reproductive Rights: ‘Abortion-Pill Reversal’

July 19, 2017

(New York Times) – As public discussion about abortions has focused on surgical abortions, the anti-abortion movement has notched victory after victory, chipping away at abortion access through a constellation of state laws that heavily regulate clinics, starve providers of funds and require women to undergo ‘‘counseling’’ or waiting periods before procuring the procedure. As a result, at least 162 abortion providers closed or stopped offering the service between 2011 and 2016, according to a Bloomberg analysis, while just 21 new providers opened. In the Midwest and the South, more than half of all women live in counties with no abortion provider at all. But today, 17 years after RU-486 was approved, medication abortion is approaching its initial promise — or threat, depending on your point of view. American women now end their pregnancies with medication almost as often as they do with surgery, according to data analyzed last fall by Reuters.

The Myth of Drug Expiration Dates

July 18, 2017

(ProPublica) – Once a drug is launched, the makers run tests to ensure it continues to be effective up to its labeled expiration date. Since they are not required to check beyond it, most don’t, largely because regulations make it expensive and time-consuming for manufacturers to extend expiration dates, says Yan Wu, an analytical chemist who is part of a focus group at the American Association of Pharmaceutical Scientists that looks at the long-term stability of drugs. Most companies, she says, would rather sell new drugs and develop additional products.

U.S. Expert Visits London Hospital to Examine Baby Charlie Gard

July 18, 2017

(Reuters) – A U.S doctor offering experimental treatment to a critically ill British baby visited the London hospital where he is being treated on Monday as part of a last-ditch attempt to persuade a judge to keep the boy’s life support switched on.  The parents of Charlie Gard, who has a rare genetic condition causing progressive muscle weakness and brain damage, have been fighting a legal battle to send him to the United States for the neurologist’s experimental therapy.

‘We Are All Mutants Now’: the Trouble with Genetic Testing

July 18, 2017

(The Guardian) – When scientists test for mutations in large numbers of genes with a single test, known as a gene panel, they are virtually guaranteed to find at least one [variant of unknown significance], says Colleen Caleshu, a genetic counsellor at Stanford University’s Center for Inherited Cardiovascular Disease. “The more genes you look at, the more variation you’ll find,” she adds. “We all have tons of variations in our genes, most of which are extremely rare and, by the very nature of rarity, uninterpretable.” In short, there isn’t enough data to know what you are seeing.

Prenatal Testing Spots Genetic Anomalies Linked to Miscarriage

July 18, 2017

(New Scientist) – A blood test can scan a fetus’s entire genome for chromosomal abnormalities at 10 weeks of pregnancy. An extension of the non-invasive prenatal test (NIPT) for Down’s syndrome, the test could identify pregnancies that should be monitored more closely as they are at a higher risk of miscarriage or complications. Chromosomal abnormalities occur in around 1 in 1000 births. The most common are Down’s syndrome, Edwards’ syndrome and Patau syndrome, which are caused by carrying an extra copy of a chromosome – chromosome 21 in the case of Down’s. These can all be detected by the form of NIPT currently offered by private clinics in the UK, US and Australia. This test is also set to be offered by the UK National Health Service from next year.

Charlie Gard Case Threatens All Parents

July 17, 2017

(USA Today) – By virtue of the deep bonds between parents and their children, Charlie’s parents are the ones most directly responsible for him, most invested in his well-being and most profoundly affected by his fate. The primary authority of parents to make decisions on their children’s behalf is widely recognized as a matter of principle and explicitly articulated in law. The United State Supreme Court has recognized the rights of parents in cases like Meyer v. Nebraska, Pierce v. Society of Sisters, and Wisconsin v. Yoder. Likewise, the European Convention of Human Rights (Article 8) and the Universal Declaration of Human Rights (Article 12) recognize the right to be free from arbitrary interference in private and family life. By contrast, one of the hallmarks of totalitarian regimes is the elimination of genuine parental decision-making authority and family privacy.

New Study Bolsters View That Mosaic Embryos from IVF Can Develop into Healthy Babies

July 17, 2017

(Genome Web) – However, for a small fraction of embryos, testing reveals they are a mosaic, meaning they have a mix of chromosomally normal and abnormal cells, with varying percentages. The field has debated for some time, and there is no consensus yet, whether such embryos should be considered for transfer if a woman has no euploid embryos available, as it might be her only chance to have a child, however, at a risk. New research by a team in Italy now shows that mosaic embryos can develop into healthy babies, and that the chance of this happening is correlated with the percentage of abnormal cells in the mosaics.

Panel Calls on FDA to Review Safety of Opoiod Painkillers

July 17, 2017

(ABC News) – The U.S. Food and Drug Administration should review the safety and effectiveness of all opioids, and consider the real-world impacts the powerful painkillers have, not only on patients, but also on families, crime and the demand for heroin. That’s the conclusion of a sweeping report Thursday from the National Academies of Sciences, Engineering and Medicine. It urges the FDA to bolster a public health approach that already has resulted in one painkiller being pulled from the market. Last week, the maker of opioid painkiller Opana ER withdrew its drug at the FDA’s request following a 2015 outbreak of HIV and hepatitis C in southern Indiana linked to sharing needles to inject the pills.

‘Are you saying I’m dying?’ Training Doctors to Speak Frankly about Death

July 17, 2017

(STAT News) – In response, advocates for improving end-of-life care have launched training sessions for doctors around the country. In California, Stanford’s palliative medicine department has trained dozens of hospice nurses using exercises similar to those carried out here by Alive. In New York, oncologists at the University of Rochester Medical Center observe their peers having conversations with real patients facing terminal illness. In Arizona, the administrators of Phoenix-based Hospice of the West hold regular training sessions, complete with small group discussions, at staff meetings.

Fewer U.S. Hospitals Can Care for Children

July 14, 2017

(Reuters) – In Massachusetts, a child who winds up in an emergency room – whether for a routine or a serious problem – is likely to be transferred to a second hospital for care, a “potentially concerning” trend that’s being reported by physicians throughout the United States, researchers say. At the root, they maintain, is the disappearance of pediatric community hospital care.

Some Doctors Were Handing Out Opioids Like Candy. The Justice Department Just Shut Them Down.

July 14, 2017

(Vox) – The US Department of Justice just took what it calls its biggest action against opioid-related fraud ever. The department announced Thursday that it’s charged 120 people with opioid-related crimes. That includes doctors who were allegedly running pill mills in which they unscrupulously prescribed opioids to patients. It also includes fraudulent treatment centers, which attract customers with promises of treatment for their addiction and then offer shoddy, ineffective services — if any at all.

Denmark’s Contraception Aid to Africa ‘to Limit Migration’

July 14, 2017

(BBC) – Denmark has pledged more funds for family planning in developing nations, saying this could also help “limit the migration pressure on Europe”. The Minister for Development Co-operation, Ulla Tornaes, said Copenhagen would contribute 91m kroner (£11m; $14m) for the programme. She said unwanted pregnancies had “enormous” human and social costs in the world’s poorest nations. But she added that limiting Africa’s population growth was also important.

China’s Sperm Count Problem Has Created a Billion-Dollar Market

July 14, 2017

(Bloomberg) – A paradox has emerged in China: As the country finally relaxes its one-child policy, factors like lower sperm counts, later pregnancies and other health barriers are making it harder for many to get pregnant. As a result, businesses from China to Australia, and even California are lining up to help — and profit from — the growing market of hopeful prospective parents.

A New Edition of Information, Communication & Society Is Now Available

July 14, 2017

Information, Communication, and Society (vol. 20, no. 7, 2017) is available online by subscription only.

Articles include:

  • “Keeping Data Alive: Talking DTC Genetic Testing” by Minna Ruckenstein

 

A New Edition of JAMA Internal Medicine Is Now Available

July 14, 2017

JAMA Internal Medicine (online first) has new articles available online by subscription only.

Articles include:

  • “Effect of a Price Transparency Intervention in the Electronic Health Record on Clinician Ordering of Inpatient Laboratory Tests: The PRICE Randomized Clinical Trial” by Mina S. Sedrak et al.

 

A New Edition of Medical Law Review Is Now Available

July 14, 2017

Medical Law Review (vol. 25, no. 1, 2017) is available online by subscription only.

Articles include:

  • “Learning from Cross-Border Reproduction” by Emily Jackson et al.
  • ” Liminality and the Limits of Law in Health Research Regulation: What are we Missing in the Spaces in-Between?” by Graeme Laurie
  • “The Social Life of Abortion Law: on Personal and Political Pedagogy” by Nicky Priaulx
  • “No-Fault Compensation for Adverse Events Following Immunization: A Review of Chinese Law And Practice” by Lanfang Fei and Zhou Peng

 

Zika Vaccines Protect Mouse Fetuses

July 13, 2017

(The Scientist) – Pregnant women and their children bear the destructive brunt of Zika, and since appreciating the connection between prenatal viral infection and the irreparable fetal harm associated with Congenital Zika Syndrome, independent groups of scientists are taking initial steps toward protecting those most vulnerable. In a first-of-its-kind study published today (July 13) in Cell, researchers demonstrated that in mice, either of two vaccines—a live attenuated virus and a non-replicating, modified mRNA vaccine—can impede Zika transmission from mother to baby in utero. These data come two weeks after a multi-disciplinary collaborative of bioethicists, physicians, and immunologists published a set of guidelines outlining how to conscientiously incorporate pregnant women into Zika vaccine trials.

The Truth about China’s Cash-for-Publication Policy

July 13, 2017

(MIT Technology Review) – These guys have surveyed the financial incentives offered by the top 100 universities in China and mined that data for interesting trends. They say that cash-per-publication incentives are common and that scientists who publish in the top Western journals can earn in excess of $100,000 per paper. What’s more, there are already worrying signs that these financial rewards are skewing the process of science in China.

Why Charlie Gard’s Case Is so Disturbing to Americans

July 13, 2017

(STAT News) – In America, however, numerous state laws explicitly state that quality-of-life determinations and decisions about withdrawing life-sustaining care must come from the patient, his or her family, or another available surrogate, as in New York’s Family Health Care Decisions Act. In clinical practice in the U.S., ethicists often encounter cases in which the care team thinks that life support should be turned off for the same reasons cited by the British and European courts in Charlie’s case. But as long as there is an available surrogate decision maker, no one other than that individual can decide to withdraw life support.

South Korea OKs First-in-Class Gene Therapy for Osteoarthritis

July 13, 2017

(Genetic Engineering & Biotechnology News) – South Korea’s Ministry of Food and Drug Safety said today that it has approved the country’s first gene therapy for osteoarthritis, the lead product candidate of a Maryland-based regenerative medicine company. Invossa-K Inj. was developed by Maryland-based TissueGene, whose Korean licensee, Kolon Life Sciences, won approval for the injectable treatment. According to the company, Invossa is a first-in-class cell-mediated gene therapy designed to treat moderate (Kellgren and Lawrence grade 3) knee osteoarthritis through regeneration of cartilage.

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