Bioethics News.
04/24/2018
U.S. agencies clash over who should regulate genetically engineered livestock
Science
A disease that kills millions of pigs a year may soon meet its match — if two federal agencies can agree on the idea.
Porcine reproductive and respiratory syndrome virus is one of the latest examples of a condition that scientists believe they can beat with genetic engineering, and one that’s caught up in a disagreement between the U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA) over how quickly such methods should be approved, and by whom.
04/23/2018
Can a genetic weapon combat one of the world’s major crop destroyers?
Science
The spotted wing fruit fly is one of the world’s major crop destroyers. Scientifically known as Drosophila suzukii, this peppercorn-size insect uses a serrated organ to lay its eggs inside—rather than on top of—unripe fruit, damaging raspberry, strawberry, and cherry crops across the globe. Now, scientists may have found a way to fight this pest using a strategy called gene drive, which can spread genes rapidly through a population.
04/20/2018
Why doctors don’t use alternatives to opioids
The New York Times
As Congress deliberates how to respond to the surging opioid epidemic, a number of bills have been introduced to support the development and Food and Drug Administration approval of a non-opioid pain medication. But the problem in American medicine is not a lack of alternatives to opioids, but the minimal utilization of the many non-opioid treatments for pain that already exist.
04/20/2018
We’re Bad at Evaluating Risk. How Doctors Can Help.
The New York Times
My patient and I were locked in a game of decision-making hot potato. “What would you do, Doc?” he said. We’d been discussing whether he should get screened for prostate cancer. Such questions trouble most doctors. We often lob the choice back to patients, or “on the one hand, on the other hand” so much that they start sympathizing with Harry Truman, who reportedly joked he wished for one-handed advisers.
04/19/2018
Artificial intelligence must be ‘for common good’
BBC News
The Lords’ report said the UK has the potential to be a leader in developing AI and called on the government to support businesses in the field. It also recommended that people be educated to work alongside AI in the jobs of the future. It said that such education would “mitigate the negative effects” on jobs which are possible as AI develops.
04/18/2018
Drug companies get tax windfall, but they’re not reducing prescription prices
USA Today
Drug prices are a top pocketbook issue for Americans. President Trump understood that and campaigned on promises to bring down the cost of prescriptions. You’d think the massive tax cut he signed into law in December would be the perfect opportunity for drug companies to take some of their windfall and bring down those prices. But a new analysis shows that so far, you’d be wrong.
04/17/2018
The Drug Overdose Epidemic and Deceased-Donor Transplantation in the United States: A National Registry Study
Annals of Internal Medicine
The epidemic of drug overdose deaths in the United States has led to an increase in organ donors.
04/17/2018
Drug Company ‘Shenanigans’ to Block Generics Come Under Federal Scrutiny
The New York Times
Trump administration officials, seeking ways to lower drug costs, are targeting pharmaceutical companies that refuse to provide samples of their products to generic drug companies, making it impossible to create inexpensive generic copies of a brand-name medicine.
04/16/2018
Employees Jump at Genetic Testing. Is That a Good Thing?
The New York Times
Genetic disease risk screening is becoming a popular employee benefit. But the tests may not be all that beneficial for the general population, experts say.
04/13/2018
Vaping now an epidemic among US high schoolers
CNN
A sharp spike in vaping and the use of e-cigarettes by students has grabbed the attention of the US Food and Drug Administration. The rapid spread of the fad was flagged in a 2016 report from the US surgeon general. It cited a 900% increase in e-cigarette use by high school students from 2011 to 2015, and the 2016 National Youth Tobacco Survey noted that 1.7 million high school students said they had used e-cigarettes in the previous 30 days.
04/12/2018
Artificial intelligence reveals how U.S. stereotypes about women and minorities have changed in the past 100 years
Science
How do you measure the stereotypes of the past after the past is gone? You could read what people wrote and tally up the slurs, but bias is often subtler than a single word. Researchers are now developing artificial intelligence (AI) to help out. A new study has analyzed which stereotypes are still holding fast—and which are going the way of the floppy disk.
04/11/2018
Squeaky clean mice could be ruining research
Nature
On an unseasonably warm February morning, Mark Pierson takes a 20-minute drive to one of Minneapolis’s larger pet shops. Pierson, a researcher in an immunology laboratory at the University of Minnesota, often comes here to buy mice, so most of the staff know him. Today he asks for ten, and an employee fishes them out of a glass box. Pierson requests the smaller mice because they’re typically younger, but he isn’t too picky. They probably all have what he wants: germs.
04/11/2018
U.S. Food and Drug Administration Precertification Pilot Program for Digital Health Software: Weighing the Benefits and Risks
Annals of Internal Medicine
In 2017, the U.S. Food and Drug Administration (FDA) announced a new program for software classified as a medical device. The Digital Health Software Precertification (Pre-Cert) Program is designed to expedite regulatory review for companies that demonstrate quality and organizational excellence in software development. Although Pre-Cert is intended to promote the worthy goals of access and innovation in digital health, many questions have been raised. In particular, Pre-Cert may reduce incentives for developers to study the safety and effectiveness of their software products before patients start to rely on them. Although postmarket surveillance can mitigate risks of these products, the FDA does not have as much authority after a product’s widespread use to enforce data collection deadlines. Pre-Cert may also create confusion for patients and physicians, who may believe that marketed products were subject to rigorous study.
04/10/2018
Facebook’s facial recognition violates user privacy, watchdog groups plan to tell FTC
USA Today
Already under siege over loose privacy controls and Russian manipulation, Facebook is about to be challenged on another issue: facial recognition. The Electronic Privacy Information Center and several other consumer groups plan Friday to file a complaint with the Federal Trade Commission asking for an investigation into the network’s use of facial recognition technology.
04/09/2018
Facebook Decides Now’s Not a Great Time to Harvest Patients’ Medical Data
Fortune
According to CNBC, the company was as recently as last month talking to the likes of Stanford Medical School about setting up a data-sharing agreement for a research project with a focus on heart disease. “This work has not progressed past the planning phase, and we have not received, shared, or analyzed anyone’s data,” Facebook told CNBC, which reported that the plan was put on hold following the Cambridge Analytica data privacy scandal, and the subsequent revelations about Facebook’s data-sharing practices.
04/07/2018
Facebook: ‘Malicious actors’ used its tools to discover identities and collect data on a massive global scale
The Washington Post
Facebook said Wednesday that “malicious actors” took advantage of search tools on its platform, making it possible for them to discover the identities and collect information on most of its 2 billion users worldwide.
04/06/2018
To treat some diseases, researchers are putting immune cells on a diet
Science
Once triggered into action, an immune cell overhauls its metabolism, making changes that could be exploited for treatment.
04/05/2018
NIH moves to punish researchers who violate confidentiality in proposal reviews
Science
When a scientist sends a grant application to the U.S. National Institutes of Health (NIH) in Bethesda, Maryland, and it goes through peer review, the entire process is supposed to be shrouded in secrecy. But late last year, NIH officials disclosed that they had discovered that someone involved in the proposal review process had violated confidentiality rules designed to protect its integrity. As a result, the agency announced in December 2017 that it would rereview dozens of applications that might have been compromised.
04/04/2018
Pioneering Alzheimer’s study in Colombia zeroes in on enigmatic protein
Nature
Researchers tracking a genetic mutation that causes an early-onset form of the disease hope to uncover new drug targets.
04/04/2018
DEA’s opioid crackdown brings arrests of prescribers, pharmacists
Washington Post
The Drug Enforcement Administration arrested 28 drug prescribers and pharmacists, and revoked the licenses of 147 people who handle controlled substances, as part of a nationwide crackdown on the illegal use and distribution of opioids and other prescription medications, the Justice Department announced Monday.
04/03/2018
California Supreme Court lets stand controversial law allowing DNA collection upon arrest
The Los Angeles Times
For years civil libertarians hoped to end California’s practice of taking DNA from people arrested on suspicion of a felony and storing that genetic information in an offender database — regardless of whether the suspects were later acquitted or had their charges dropped. That fight for more protective rules in the government’s DNA collection suffered a major setback Monday when the California Supreme Court let stand a provision of a 2004 voter initiative that said any adult arrested or charged with a felony must give up his or her DNA.
04/03/2018
Sudden infant death syndrome may have genetic basis, study suggests
CNN
Sudden infant death syndrome — long regarded as an unexplained phenomenon affecting apparently healthy children under 1 — may have a genetic basis in some cases, a new study suggests. The study, published Wednesday in the journal The Lancet, found that a genetic mutation affecting respiratory muscle function was associated with SIDS in a subset of cases.
04/02/2018
False-positive results released by direct-to-consumer genetic tests highlight the importance of clinical confirmation testing for appropriate patient care
Nature
There is increasing demand from the public for direct-to-consumer (DTC) genetic tests, and the US Food and Drug Administration limits the type of health-related claims DTC tests can market. Some DTC companies provide raw genotyping data to customers if requested, and these raw data may include variants occurring in genes recommended by the American College of Medical Genetics and Genomics to be reported as incidental/secondary findings. The purpose of this study was to review the outcome of requests for clinical confirmation of DTC results that were received by our laboratory and to analyze variant classification concordance.
04/02/2018
Planned Parenthood tweet calls for abortion Disney princess
BBC News
Chief executive Melissa Reed said: “Today, we joined an ongoing Twitter conversation about the kinds of princesses people want to see in an attempt to make a point about the importance of telling stories that challenge stigma and championing stories that too often don’t get told. “Upon reflection, we decided that the seriousness of the point we were trying to make was not appropriate for the subject matter or context, and we removed the tweet.”
03/30/2018
Duke’s mishandling of misconduct prompts new U.S. government grant oversight
Science
Last week, the U.S. National Institutes of Health (NIH) imposed unusual new requirements on researchers based at Duke University in Durham, North Carolina, who receive federal funds. The changes are a response to concerns over how the institution handled recent cases involving research misconduct and grant management.
03/29/2018
Facebook says you ‘own’ all the data you post. Not even close, say privacy experts
LA Times
“Facebook’s terms of service are quite obviously of no value to consumers,” said Sam Lester, consumer privacy fellow at the Electronic Privacy Information Center in Washington, D.C. “Consumers had no knowledge that a controversial data mining firm was accessing their personal data.”
03/29/2018
The Struggle to Build a Massive ‘Biobank’ of Patient Data
The New York Times
The goal is to find one million people in the United States, from all walks of life and all racial and ethnic groups, who are willing to have their genomes sequenced, and to provide their medical records and regular blood samples.
They may choose to wear devices that continuously monitor physical activity, perhaps even devices not yet developed that will track heart rate and blood pressure. They will fill out surveys about what they eat and how much.
If all goes well, experts say, the result will be a trove of health information like nothing the world has seen. The project, called the All of Us Research Program, should provide new insights into who gets sick and why, and how to prevent and treat chronic diseases.
03/28/2018
How Genetics Is Changing Our Understanding of ‘Race’
The New York Times
In 1942, the anthropologist Ashley Montagu published “Man’s Most Dangerous Myth: The Fallacy of Race,” an influential book that argued that race is a social concept with no genetic basis. A classic example often cited is the inconsistent definition of “black.” In the United States, historically, a person is “black” if he has any sub-Saharan African ancestry; in Brazil, a person is not “black” if he is known to have any European ancestry. If “black” refers to different people in different contexts, how can there be any genetic basis to it?
03/27/2018
Former FDA commissioners say right-to-try bills could endanger ‘vulnerable patients’
Washington Post
Four former heads of the Food and Drug Administration have issued a joint statement opposing “right to try” legislation that is designed to permit desperately sick patients to get experimental treatments without the approval of the agency.
03/26/2018
Female doctors have problems men can’t fathom. Are we even welcome at work?
USA Today
For decades, most analyses of female physicians were limited to small populations, and so what was known was not widely actionable. But in 2010, the Patient Protection and Affordable Care Act required the government to disclose physician demographics and Medicare reimbursements, and this has allowed researchers to paint a more complete picture of what it is like to be a working woman. It came as no surprise that after adjusting for experience, effort, and productivity, female physicians generally are paid significantly and substantially less by Medicare ($18,677 on average annually) than males. But it was surprising to see that women were not merely non-inferior to men as providers. Having a female physician can actually confer an advantage in patient care.