News from Bioethics.com

The Startup That Manipulated Data to Get a Miracle Drug to Market

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(Wall Street Journal) – The startup had something incredible: a cure for babies with a deadly neurological disease. Last year, the company was snapped up by pharmaceutical giant Novartis AG NVS -0.98% , and by this past May, its drug was the most expensive on the market. In just a few years, the company, AveXis Inc., morphed from a handful of hospital-based researchers into one of the pharmaceutical industry’s most stunning success stories.  But in the hurry to fulfill the drug’s promise, AveXis manipulated data that went into the drug’s approval, Novartis and the Food and Drug Administration now say. 

Thousands of Fetal Remains Found on Illinois Property of Deceased Doctor

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(Independent Journal Review) – More than 2,200 preserved fetal remains have been found on the Illinois property of a recently deceased doctor who performed abortions, the Will County sheriff’s office said in a statement. The family and attorney of Ulrich Klopfer, who died on Sept. 3, discovered 2,246 medically preserved fetal remains on Thursday while going through the deceased doctor’s personal property and alerted the local coroner’s office, the sheriff’s office said.

The Apple Watch’s Next Trick Could Be Battling Pseudoscience–But Questions Remain

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(Gizmodo) – Before launching into its battery of Apple Watch announcements on Tuesday, Apple set the tone, as it often does, with a moving promotional video. Among the many characters featured was a mother who described how the Apple Watch helped catch a pregnancy-endangering heart condition. She rushed to the hospital, and her baby was saved. Later, Apple announced it would expand its health initiatives by embarking on three new health research studies that will use data gathered by its smartwatch. The Apple Watch, like most wearables, is billed as a product that can help you live a healthier life. These studies are Apple’s latest effort to prove that’s more than marketing bluster. 

Column: A Stem Cell Clinic Under Fire by the FDA and Ex-Patients Files for Bankruptcy

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(Los Angeles Times) – StemGenex, the operator of a La Jolla clinic that drew a warning from the Food and Drug Administration that its purported stem cell treatments were illegal, has filed for bankruptcy. The clinic also is facing a class-action lawsuit in San Diego federal court brought by several former customers who say they were misled by its advertising and marketing.

Purdue Pharma, Maker of OxyContin, Files for Bankruptcy

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(New York Times) – Purdue Pharma, maker of OxyContin, the drug widely seen as igniting the opioid crisis, filed for Chapter 11 bankruptcy on Sunday night, a move at the center of the company’s efforts to shield itself and its owners from more than 2,600 federal and state lawsuits. The terms of the filing, which include a proposed resolution of most of those cases, are expected to be fiercely contested by a group of states — led by Massachusetts and New York — that have refused to settle with Purdue and are intent on pursuing the company’s owners, the Sacklers, considered one of the wealthiest families in the United States. A showdown in bankruptcy court in White Plains could come as early as this week.

‘The Switch’ Was Supposed to Be a Major Step Toward Eradicating Polio. Now It’s a Quandary

2 months 2 days

(STAT News) – Three years ago, the leaders of the international campaign to eradicate polio pulled off a landmark feat, phasing out a problematic component of the vaccine used in developing countries, and introducing a newer version that they hoped would put the world on a better footing to finally eliminate a global scourge. Now, some organizers are weighing whether “the switch,” as the process was known, needs to be reversed. If it’s not, some fear, the world could face a heightened risk of spread of the disease, currently confined to its last redoubt, Pakistan and Afghanistan.

Kenya Becomes Third African Nation to Introduce Malaria Vaccine

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(Reuters) – Kenya on Friday began adding a malaria vaccine to its routine immunization schedule for babies and toddlers, becoming the third African country to roll out the vaccine for a disease that threatens children across the continent. Malaria, which kills one child globally every two minutes, is the top killer of children under five in the east African country. The vaccine – the world’s first against malaria – will be administered to children under two and could be crucial to efforts to combat the disease, health officials said.

A Woman’s AncestryDNA Test Revealed a Medical Secret

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(The Atlantic) – In 2017, Holly Becker took an AncestryDNA test, and the results, she would only later learn, exactly matched those of a young man in New York. This was strange, but the test was not wrong. She really did have his DNA inside her. Two decades ago, she had undergone an umbilical-cord-blood transplant to treat her non-Hodgkin’s lymphoma. The anonymous donor’s cells became her cells, and they still course through her body today. That is what the AncestryDNA test had picked up.

The Redemption of James Wilson, Gene Therapy Pioneer

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(Chemical & Engineering News) – For anyone familiar with the slow crawl of drug development, gene therapy is moving at lightning speed. The approval of the first two gene therapies in the US and promising clinical data on many more have supercharged the field. Money, hard to raise not long ago, is flooding into academic labs and companies developing gene therapies. The FDA can barely keep up with the growing pipeline, and it anticipates receiving more than 200 applications from groups that want to test new cell and gene therapies next year. The pace is a source of both excitement and anxiety for anyone who’s weathered gene therapy’s peaks and troughs over the past 3 decades. And of all the field’s pioneers, 64-year-old Wilson may feel that tension more strongly than anyone.

Dutch Euthanasia Case: Doctor Acted in Interest of Patient, Court Rules

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(BBC) – A doctor accused of failing to verify consent before performing euthanasia on a dementia patient has been cleared of any wrongdoing by a Dutch court. The 74-year-old patient, who died in 2016, had expressed a wish to be euthanised but also indicated that she wanted to determine the right time. Judges said the doctor acted lawfully as not carrying out the process would have undermined the patient’s wish. It is the first such case since the country legalised euthanasia in 2002.

Apple Launching Studies Testing Whether Apple Watch Can Monitor Hearing, Mobility, and Women’s Health

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(STAT News) – Apple (AAPL) on Tuesday announced that it’s launching three research studies that will assess the Apple Watch’s capabilities in monitoring women’s medical conditions, hearing health, and mobility signals like heart rate and walking pace. It’s the latest sign of Apple’s rising profile and ambition as a player in medical research — centered around a consumer gadget that has yet to demonstrate that it offers widespread health benefits for individuals or the population at large.

US to Ban Flavored Vaping Products as Lung Disease Cases Surge

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(Medical Xpress) – Donald Trump’s administration on Wednesday announced it would soon ban flavored vaping products, amid a growing outbreak of severe lung disease linked to e-cigarette use that has claimed six lives. Addressing reporters at the White House, the US president said he and First Lady Melania Trump were worried as parents about the wave of illnesses that has sickened hundreds and left several teens in induced comas.

‘There’s No Such Thing as Anonymity’: With Consumer DNA Tests, Sperm Banks Reconsider Long-Held Promises to Donors

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(STAT News) – For generations, it was a basic tenet of donating sperm: Clinics could forever protect their clients’ identities. But, increasingly, donor anonymity is dead. The rise of consumer genetic tests — which allow people to connect with relatives they never knew they had, including some who never intended to be found in the first place — is forcing sperm donation clinics to confront the fact that it is now virtually impossible to guarantee anonymity to their clients. Instead, sites like 23andMe and Ancestry.com are giving customers the genetic clues they need to identify biological parents on their own.

OxyContin Maker Purdue Pharma Agrees to Tentative Settlement in Opioid Lawsuit

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(STAT News) – OxyContin maker Purdue Pharma reached a tentative deal Wednesday with about half the states and thousands of local governments over its role in the nation’s deadly opioid epidemic, but criticism by several state attorneys general clouded prospects for an end to litigation against the company and the family that owns it.

Chinese Scientists Try to Cure One Man’s HIV with CRISPR

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(Wired) – In July of 2017, doctors in Beijing blasted the patient with chemicals and radiation to wipe out his bone marrow, making space for millions of stem cells they then pumped into his body through an IV. These new stem cells, donated by a healthy fellow countryman, would replace the patient’s unhealthy ones, hopefully resolving his cancer. But unlike any other routine bone marrow transplant, this time researchers edited those stem cells with Crispr to cripple a gene called CCR5, without which HIV can’t infiltrate immune cells.

The Family That Build an Empire of Pain

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(New Yorker) – Purdue launched OxyContin with a marketing campaign that attempted to counter this attitude and change the prescribing habits of doctors. The company funded research and paid doctors to make the case that concerns about opioid addiction were overblown, and that OxyContin could safely treat an ever-wider range of maladies. Sales representatives marketed OxyContin as a product “to start with and to stay with.” Millions of patients found the drug to be a vital salve for excruciating pain. But many others grew so hooked on it that, between doses, they experienced debilitating withdrawal.

Scientists Create a Device That Can Mass-Produce Human Embryoids

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(NPR) – Scientists have invented a device that can quickly produce large numbers of living entities that resemble very primitive human embryos. Researchers welcomed the development, described Wednesday in the journal Nature, as an important advance for studying the earliest days of human embryonic development. But it also raises questions about where to draw the line in manufacturing “synthetic” human life.

Contaminant Found in Marijuana Vaping Products Linked to Deadly Lung Illness, Tests Show

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(The Washington Post) – State and federal health officials investigating mysterious lung illnesses linked to vaping have found the same chemical in samples of marijuana products used by people sickened in different parts of the country and who used different brands of products in recent weeks. The chemical is an oil derived from vitamin E. Investigators at the U.S. Food and Drug Administration found the oil in cannabis products in samples collected from patients who fell ill across the United States. 

Period Tracker Apps Used by Millions of Women Are Sharing Incredibly Sensitive Data with Facebook

2 months 5 days

(Buzz Feed) – Period tracker apps are sending deeply personal information about women’s health and sexual practices to Facebook, new research has found. UK-based advocacy group Privacy International, sharing its findings exclusively with BuzzFeed News, discovered period-tracking apps including MIA Fem and Maya sent women’s use of contraception, the timings of their monthly periods, symptoms like swelling and cramps, and more, directly to Facebook. Women use such apps for a range of purposes, from tracking their period cycles to maximizing their chances of conceiving a child.

European Doctor Who Prescribes Abortion Pills to U.S. Women Online Sues FDA

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(NPR) – A European doctor who prescribes abortion pills to American women over the Internet is suing the Food and Drug Administration in an effort to continue providing the medications to patients in the United States. The lawsuit being filed Monday in federal court in Idaho names several federal officials, including U.S. Health and Human Services Secretary Alex Azar.

A Human Liver Can Be Cooled to -4 Degrees Celsius and Still Survive

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(The Atlantic) – On ice, a liver destined for transplant can last nine, maybe 12 hours. A lot must happen in this time: The liver must be flown to another hospital, a surgical team assembled, an operating room prepped, a recipient rushed into surgery, and the diseased liver carefully removed. Each hour on ice, the liver deteriorates; too many hours, and it will never function in a human body again. Ice can only do so much to slow biological time. For this reason—along with the sobering statistic that 20 people die every day waiting for a transplant—doctors and scientists have long sought ways to preserve organs. Biologists now report a new strategy tested on five human livers: supercooling the organ to 4 degrees Celsius below zero, or just under 25 degrees Fahrenheit.

US Couple Lose Child Custody Over Chemo Refusal

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(BBC) – A cancer-stricken four-year-old boy in Florida has been ordered to live with his grandmother after his parents prevented him from having chemotherapy. The custody ruling on Monday against parents Taylor Bland and Joshua McAdams came after their bid for alternative treatment garnered national attention. The boy was taken from his parents in April after they skipped chemotherapy and left the state.

Google, Mayo Clinic Strike Sweeping Partnership on Patient Data

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(STAT News) – Mayo Clinic, one of medicine’s most prestigious brands, announced Tuesday that it has struck a sweeping partnership with Google to store patient data in the cloud and build products using artificial intelligence and other technologies to improve care. The 10-year partnership is a testament to Google’s expanding role in the U.S. health care system and gives Mayo greater access to the engineering talent and computing resources it needs to embed its expertise in algorithms and commercial devices.

How an AI Startup Designed a Drug Candidate in Just 46 Days

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(Singularity Hub) – Discovering a new drug can take decades, billions of dollars, and untold man hours from some of the smartest people on the planet. Now a startup says it’s taken a significant step towards speeding the process up using AI. The typical drug discovery process involves carrying out physical tests on enormous libraries of molecules, and even with the help of robotics it’s an arduous process. The idea of sidestepping this by using computers to virtually screen for promising candidates has been around for decades. But progress has been underwhelming, and it’s still not a major part of commercial pipelines.

New Google Policy Bars Ads for Unproven Stem Cell Therapies

2 months 6 days

(The Washington Post) – Responding to ubiquitous online marketing by stem cell clinics selling unapproved treatments for everything from achy joints to Alzheimer’s, Google announced Friday it will no longer accept ads for “unproven or experimental medical techniques,” including most stem cell therapy, cellular therapy and gene therapy. The Internet giant said it was taking the step after seeing “a rise in bad actors” trying to take advantage of patients by offering “untested, deceptive treatments.”

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