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Who Owns H.I.V.-Prevention Drugs? The Taxpayers, U.S. Says

November 8, 2019

(New York Times) – After years of prodding by patient advocates, federal officials on Wednesday sued the drug maker Gilead Sciences, charging that it had infringed government patents on the idea of preventing H.I.V. with a daily pill. The suit, by the Department of Health and Human Services, came as a pleasant shock to many critics of the company, including Democratic members of Congress who had pressed the administration to act. It is very rare for the government to take on a drug maker over patents. 

CRISPR Approach to Fighting Cancer Called ‘Promising’ in 1st Safety Test

November 8, 2019

(NPR) – The powerful gene-editing technique known as CRISPR has raised a lot of hope in recent years for its potential to offer new ways to treat many diseases, including cancer. But until now, scientists have released very little information about results of tests in patients. On Wednesday, researchers revealed data from the first study involving U.S. cancer patients who received cells genetically modified with CRISPR. The highly anticipated results, while quite preliminary, seem to be encouraging, scientists say.

How Unproven Stem Cell Therapies Are Costing Desperate Patients

November 8, 2019

(Texas Monthly) – On a Wednesday afternoon in September 2018, Dilley and her mother arrived at the Houston clinic and, while in the waiting room, chatted with the other patients. They learned that a few others were also from Brazoria County and had read about stem cells in “Conversations With Gin.” They’d come seeking relief from neck pain, back pain, and arthritis. One by one, they were called back to an area where they sat in recliners and were handed frozen vials, about the size of a paper clip, which they were instructed to warm in their fists. The contents were then transferred to a syringe and injected.

‘Crimes Against Humanity’: Is China Killing Political Prisoners for Their Organs?

November 8, 2019

(Sydney Morning Herald) – In the years following, he often thought back on the X-rays and blood tests. He thought about when the prisoners were instructed by the guards not to injure his organs. Though he had heard whispers of prisoners being killed for their organs, he had always found it hard to believe. Then he remembered one particular day, in 2007. He had been in his cell when a senior guard, named Li Wei, came to see him privately. “He bent down so we were almost face to face, and said, ‘Nothing is impossible!’?” In December 2018, Tony gave evidence via phone to the China Tribunal, an independent inquiry held in London into the murder in China of prisoners of conscience for their organs.

A New Type of Genetic Profiling Promises Cleverer, Better-Looking Children.

November 7, 2019

(The Economist) – There is, however, a third way that the genetic dice which are thrown at the beginning of human life might be loaded—and it does not involve any risky tinkering. It is a twist on the well-established procedure of in vitro fertilisation (IVF). The twist would be to decide, on the basis of their DNA, which of a group of available embryos should be implanted and brought to term. The result would be a child optimised with the best-available genetic profile for a long and healthy life. And this is not science fiction.

Sequencing the Genome of Every UK Baby Would Be an Ethical Minefield

November 7, 2019

(New Scientist) – Plans for the National Health Service to sequence the DNA of every baby born in the UK, starting with a pilot scheme of 20,000 children, were announced by health minister Matt Hancock this week. It sounds like the UK is leading the way in high-tech healthcare – but doctors are saying the idea is ethically questionable. Babies are already tested for certain health conditions soon after birth, so it may seem as though sequencing their genome, their entire set of genes, is a simple upgrade of this routine screening, but that isn’t the case.

‘Crisis Pregnancy Centers’ Endanger Adolescent Health, Doctors Say

November 7, 2019

(Reuters) – “Crisis pregnancy centers” look and act like healthcare clinics but fail to meet medical and ethical standards, often using biased and inaccurate information to persuade women not to pursue an abortion, say two national doctors’ groups. The “misinformation” these centers offer typically includes limited options for the next steps of pregnancy and unscientific sexual and reproductive health explanations, according to a joint statement by the Society for Adolescent Health and the North American Society for Pediatric and Adolescent Gynecology that was published in the Journal of Adolescent Health. 

A Takeda Vaccine for Dengue Appears Effective, But the Story Is Nuanced

November 7, 2019

(STAT News) – A key hurdle Takeda must clear is to demonstrate that its own vaccine is not hindered by an issue that has clouded Sanofi’s Dengvaxia vaccine, which can actually make future cases of the mosquito-borne virus more severe in people who were not previously infected. After this finding was disclosed two years ago, a widespread vaccination campaign run by the Philippine government was abruptly halted amid scandal. Sanofi has struggled ever since to make a success of the product. For the moment, Takeda reported preliminary results that are decidedly mixed.

CDC: Childhood Trauma Is a Public Health Issue And We Can Do More to Prevent It

November 7, 2019

(NPR) – Childhood trauma causes serious health repercussions throughout life and is a public health issue that calls for concerted prevention efforts. That’s the takeaway of a report published Tuesday from the Centers for Disease Control and Prevention. Experiencing traumatic things as a child puts you at risk for lifelong health effects, according to a body of research. The CDC’s new report confirms this, finding that Americans who had experienced adverse childhood experiences, or ACEs, were at higher risk of dying from five of the top 10 leading causes of death. 

Juul Disregarded Early Evidence It Was Hooking Teens

November 6, 2019

(Reuters) – The San Francisco startup that invented the groundbreaking Juul e-cigarette had a central goal during its development: captivating users with the first hit. The company had concluded that consumers had largely rejected earlier e-cigarettes, former employees told Reuters, because the devices either failed to deliver enough nicotine or delivered it with a harsh taste. Developers of the Juul tackled both problems with a strategy they found scouring old tobacco-company research and patents: adding organic acids to nicotine, which allowed for a unique combination of smooth taste and a potent dose.

The Air Ambulance Billed More Than His Surgeon Did for a Lung Transplant

November 6, 2019

(Kaiser Health News) – “Balance billing,” better known as surprise billing, occurs when a patient receives care from a medical provider outside of his insurance plan’s network, and then the provider bills the patient for the amount insurance didn’t cover. These bills can soar into the tens of thousands of dollars. Surprise bills hit an estimated 1 in 6 insured Americans after a stay in the hospital. And the air ambulance industry, with its private equity backing, high upfront costs and tendency to remain out-of-network, is among the worst offenders.

Doctors Use CRISPR Gene Editing in Cancer Patients, a First in the U.S.

November 6, 2019

(Los Angeles Times) – The first attempt in the United States to use the CRISPR gene-editing tool against cancer seems safe in the three patients who have had it so far, but it’s too soon to know whether the treatment will improve survival, doctors reported Wednesday. The doctors were able to take immune system cells from the patients’ blood and alter them genetically to help them recognize and fight cancer, with minimal and manageable side effects.

From Assisted Hatching to Embryo Glue, Most IVF ‘Add-ons’ Rest on Shaky Science, Studies Find

November 6, 2019

(STAT News) – In the 40 years since the world’s first “test tube baby,” fertility clinics have cooked up nearly three dozen such “add-ons,” or supplementary procedures. Like immune therapy for supposed genetic incompatibility, they’re not essential to IVF. Instead, clinics offer procedures such as “assisted hatching” and “embryo glue” and “uterine artery vasodilation” as purportedly science-based options that increase the chance of having a baby. Except there is little to no evidence that the vast majority of IVF add-ons do any such thing, conclude four papers published on Tuesday in Fertility and Sterility, the journal of the American Society for Reproductive Medicine.

Oversight of ‘Right to Try’ Stem Cell Market Raises Concerns, Bioethicists Say

November 5, 2019

(S & P Global) – Already troubled by the murky oversight of the rapidly expanding U.S. direct-to-consumer marketplace of unapproved stem cell therapies, bioethicists are now raising concerns about a new pathway that at least one company is taking to sell those products — the Right to Try Act. The law, adopted in May 2018, allows critically ill patients to sidestep the U.S. Food and Drug Administration in seeking access to experimental therapies. The growing unapproved stem cell market combined with the congressionally mandated laissez-faire approach for Right to Try, or RTT, could expose vulnerable patients to harm, bioethicists told S&P Global Market Intelligence.

U.S. Blames Drug Shortages on Low Prices and a ‘Broken Marketplace’

November 5, 2019

(New York Times) – Chronic drug shortages that threaten patient care are caused by rock-bottom prices for older generic medicines and a health care marketplace that doesn’t run on the rules of supply and demand, among other factors, according to a federal report published on Tuesday. The report, the work of a task force led by the Food and Drug Administration and comprising representatives from various federal agencies, recommended that buyers like hospitals consider paying higher prices for older generic drugs.

Controversy Kicks Up Over a Drug Meant to Prevent Premature Birth

November 5, 2019

(NPR) – An independent panel of advisers to the Food and Drug Administration recommended last week that a medication to prevent preterm birth be taken off the market because, the advisers decided, the preponderance of evidence suggests it doesn’t work. But some other leading OB-GYNs say they hope the FDA won’t take the panel’s advice this time. The medication, brand-named Makena, is a progestin, a synthetic form of the hormone progesterone.

The Health Care Industry Needs to Be More Honest About Medical Errors

November 5, 2019

(TIME) – Yet, in 2019, medical errors are about as prevalent as in 1999. “To Err Is Human” was an uneasy read; so is a September 2019 report on patient safety from the World Health Organization. Among WHO’s findings: Globally, hospital-acquired infections afflict about 10% of hospitalized patients. Medical errors harm some 40% of patients in primary and outpatient care. Diagnostic and medication errors hurt millions, and cost billions of dollars every year. So, two decades on, why this chronic state of risk in health care?

Measles and Mistrust in Ukraine Weaken World’s Defenses

November 4, 2019

(Reuters) – Many of the people coming to Anna Kukharuk’s private medical clinic don’t have a disease. What plagues them is doubt. But its effects are a health emergency that the doctor and hundreds of others are struggling to remedy. Deep mistrust of vaccines in Ukraine has allowed measles, a virus which according to United Nations data kills 367 children a day worldwide, to grow into an epidemic infecting more than 58,000 people in the country of 42 million this year alone.

A New Alzheimer’s Therapy Is Approved in China, Delivering a Surprise for the Field But Also Questions

November 4, 2019

(STAT News) – Chinese regulators have granted conditional approval to an Alzheimer’s drug that is derived from seaweed, potentially shaking up the field after years of clinical failures involving experimental therapies from major drug companies. The announcement over the weekend has been met with caution as well as an eagerness from clinicians and others to see full data from the drug maker, Shanghai Green Valley Pharmaceuticals. The company said its drug, Oligomannate, improved cognitive function in patients with mild to moderate Alzheimer’s compared to placebo in a Phase 3 trial, with benefits seen in patients as early as week four and persisting throughout the 36 weeks of the trial. 

Google to Acquire Fitbit for $2.1 Billion in Major Health Tech Deal

November 1, 2019

(STAT News) – Google parent company Alphabet announced on Friday it will buy Fitbit for $2.1 billion — a massive deal that will pit Google squarely against Apple (AAPL) in the market for health and fitness tracking. The deal immediately transforms the market for fitness trackers and smartwatches, which are increasingly being seen as clinical tools for monitoring health and gathering reams of health data.

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