Viewpoints: Isn’t It Time To Get Important Input From Other Sources On Gene Editing?; Prevent Another Theranos Debacle By Seeking Peer-Reviewed Work
Opinion writers weigh in on these health topics and others.
The New York Times:
Should Scientists Toy With The Secret To Life?
Scientists quickly condemned the Chinese researcher who altered the DNA of at least two embryos to create the world’s first genetically edited babies, defying a broad consensus against hereditary tinkering. But as The Times reported last week, the global scientific community is divided over what to do next. Should researchers agree to a moratorium on any human genome editing that can be passed down to future generations? Or should they simply tighten existing criteria? It’s good that the National Academies of Sciences, Engineering and Medicine are planning a global forum to address these questions. But it will be crucial for biologists to seek substantial input from policymakers, ethicists, social scientists and others. (1/28)
Peer Review Could Help Smoke Out The Next Theranos
Today, there are 309 unicorns with an aggregate valuation above $1 trillion. The median venture capital fundraise is $165 million, the highest on record. The dataset in our analysis, published Monday in the European Journal of Clinical Investigation, backdates to November 2017, when there were 18 current and 29 former (leaving the herd by acquisition or public offering) health care unicorns. We found that most unicorns published very little in the peer-reviewed literature. One-quarter published nothing. Of papers that were published, 1 in 10 were considered high-impact (garnering more than 50 citations by subsequent papers). The majority of current unicorns and 40 percent of exited unicorns had zero high-impact papers. In addition, of eight high-impact current unicorn papers, two were unrelated to the company’s product. Only one of the 34 high-impact papers involved any human subjects, and that was a retrospective observational study. (Eli Cahan, Ioana A. Cristea and John P.A. Ioannidis, 1/29)
The Wall Street Journal:
The Government Opioid Raid
Opiate addiction has ruined tens of thousands of lives, and no surprise politicians in cahoots with their trial-lawyer friends are trying to cash in on the scourge. Credit to a Connecticut judge for calling out a local raid. More than 600 government lawsuits have been filed against companies that make, distribute and sell opioids. Trial attorneys are abetting governments in return for a share of the potential payoff. While most suits are being heard by federal judge Dan Polster in Ohio, some cities have sued in home courts in hopes of receiving a more sympathetic audience and bigger reward. (1/28)
Real-World Evidence Is Changing The Way We Study Drug Safety And Effectiveness
Randomized controlled clinical trials are a great way to test the safety and effectiveness of a new drug. But when the trial is over and the drug approved, it’s used by patients and health care practitioners in settings that are quite different from the rarified clinical trial setting. Interesting, important, and sometimes surprising findings can emerge when the narrow constraints of clinical trial eligibility and intent-to-treat analyses are set aside. That’s why it’s time for biotech and pharmaceutical companies to pay more attention to understanding, and undertaking, real-world studies, an approach backed by Food and Drug Administration Commissioner Scott Gottlieb in a talk Monday on using new data sources as evidence for both regulatory evaluation and value-based payment programs. (Nancy A. Dreyer, 1/29)
Safe Injection Sites Aren’t Safe Or Legal
Promoters of supervised injection sites need to understand that, short of legislative reform, any effort to open an injection site in Massachusetts will be met with federal enforcement. Following marijuana legalization, some in the Commonwealth have come to view federal drug laws as a mere inconvenience, stubbornly antiquated rules that surely must yield to those with superior insight and the best of intentions. (Andrew Lelling, 1/28)
Reversing Oregon’s Backward Slide On Immunizations
The Clark County outbreak, like past outbreaks of vaccine-preventable diseases in Oregon and elsewhere, drives home the point that forgoing immunizations isn’t just a matter of personal choice. The long list of places where people may have been exposed to the virus – churches, schools, stores, high school basketball games, Portland International Airport – speaks to the broad reach of a family’s choice not to immunize a child. Refusing to vaccinate children puts not only them at risk but also the health of medically fragile individuals or those too young to be immunized. Oregonians and legislators must start treating our declining immunization rate as the serious threat to public health that it is and stem this backward slide. (1/25)
Cleveland Plain Dealer:
Cleveland Anti-Lead-Poisoning Coalition Is A Laudable Step Forward But It Needs A Clear Plan Of Action
Bottom line: The lead poisoning of Cleveland children has become a citywide emergency that requires tough, focused and urgent measures aimed at making the city's housing safer for families. The bad news is that the new coalition hasn't yet finalized what those measures will be. Despite their laudably strong statements of an intention to act with urgency, the 19-member coalition and its community partners still lack a timeline, overall plan of action with clear metrics and cost estimates, and identified sources of funding. (1/27)
Arizona Should Take Guns From Domestic Abusers. Anyone Disagree?
Getting a law passed that actually has a chance to protect segments of the public from gun violence has never been easy. The gun lobby in many states (including ours) has been strong enough to either have such proposals killed or watered down to the extent that they’re little more than fancy titles on do-nothing laws. (EJ Montini, 1/28)
Costly, Ineffective, Cruel: How Oregon Ensnares Mentally Ill People Charged With Low-Level Crimes
The process, known as “aid and assist,” stems from the constitutional right of people charged with crimes to be able to help in their own defense. Through it, however, the state metes out extremely high cost care that takes defendants’ liberties away for prolonged periods. And it fails in almost every case to deliver lasting benefits to defendants or to society. In Oregon, taxpayers spend as much as $35 million a year to provide institutionalized care to mentally ill people charged with misdemeanors, many of whom are homeless, a first-of-its-kind analysis by The Oregonian/OregonLive found. Nearly all those patients eventually find themselves dumped back out on the street with little to no support. Almost one in five are readmitted to the mental hospital within a year under new charges. (Gordon R. Friedman, 1/27)