The genome is static, but our ability to analyze it and interpret it is undergoing dramatic change,” said James Evans, a geneticist at the University of North Carolina in Chapel Hill
The genome is static, but our ability to analyze it and interpret it is undergoing dramatic change,” said James Evans, a geneticist at the University of North Carolina in Chapel Hill
As DNA testing gallops ahead, doctors face wrenching questions about legal risks, protecting patients’ privacy, and the quality of the genetic information they’re providing—and they need help. That was one message from a symposium yesterday at the University of Minnesota (UMN) in Minneapolis. Leaders of a $2 million project called LawSeq are wrestling with how to push the legal world to catch up to science.
“The genome is static, but our ability to analyze it and interpret it is undergoing dramatic change,” said James Evans, a geneticist at the University of North Carolina in Chapel Hill. “We don’t understand most of these variants, nor their potential impact on health and diseases … and we change our minds a lot, which is kind of frightening for patients.”
One of the biggest concerns is legal liability. Health care providers face a disconnect: Technology has outpaced their ability to interpret genetic results, such as a patient’s risk of breast cancer or heart attack from a particular mutation. Because of that, typical fallbacks including providing a rigorous standard of care—which can also act as a legal shield against malpractice claims—are becoming fuzzy. What is a doctor to do when a patient has results from a direct-to-consumer testing company like 23andMe and asks what implications they have for their health? Or when a lab notifies a doctor that a genetic variant their patient carries, thought meaningless 3 years ago, is now known to be harmful, but they can’t locate the patient? Can a testing lab be held liable for not regularly reviewing the scientific literature, to track science’s understanding of the gene variants it tests for?
A prominent pediatrician and medical researcher in the Philippines has been indicted over the failed—and many say premature—introduction of Dengvaxia, a vaccine against dengue that was yanked from the Philippine market in 2017 because of safety issues
A prominent pediatrician and medical researcher in the Philippines has been indicted over the failed—and many say premature—introduction of Dengvaxia, a vaccine against dengue that was yanked from the Philippine market in 2017 because of safety issues
A prominent pediatrician and medical researcher in the Philippines has been indicted over the failed—and many say premature—introduction of Dengvaxia, a vaccine against dengue that was yanked from the Philippine market in 2017 because of safety issues. If convicted of accusations leveled at her by the national Department of Justice (DOJ), Rose Capeding, 63, former head of the dengue department of the Research Institute for Tropical Medicine (RITM) here, could face up to 48 years in prison.
In February, prosecutors concluded there is probable cause to indict Capeding and 19 others for “reckless imprudence resulting [in] homicide,” because they “facilitated, with undue haste,” Dengvaxia’s approval and its rollout among Philippine schoolchildren.
Capeding, through her family, declined to comment, but her son Juhani Capeding says his mother “couldn’t have imagined” that submitting research to top medical journals could have led to “this point.” Some of Capeding’s colleagues agree. “As a scientist, I really feel so disgusted, dismayed, [and] heartbroken about the whole situation,” says Lulu Bravo, executive director of the Philippine Foundation for Vaccination here.
Watch now: The NAM & CSIS Commission on Strengthening America’s Health Security hosted a conversation on whether human germline genome editing should be permitted, the types of applications which might be appropriate, the standards and criteria that should be followed, and what regulatory or governance framework is needed. Panel includes our Jeffrey Kahn
Watch now: The NAM & CSIS Commission on Strengthening America’s Health Security hosted a conversation on whether human germline genome editing should be permitted, the types of applications which might be appropriate, the standards and criteria that should be followed, and what regulatory or governance framework is needed. Panel includes our Jeffrey Kahn
On Wednesday, March 27, 2:00-3:30 pm, the National Academy of Medicine and the CSIS Commission on Strengthening America’s Health Security hosted a conversation on the unfolding debate as to whether human germline genome editing should be permitted, the types of applications which might be appropriate, the standards and criteria that should be followed, and what regulatory or governance framework is needed.
Featuring:
Dr. Victor Dzau
President, National Academy of Medicine
Tim Hunt
Senior Vice President, Corporate Affairs, Editas Medicine
Jeffrey Kahn
Andreas C. Dracopoulos Director, Johns Hopkins Berman Institute of Bioethics
Anne-Marie Mazza
Senior Director, Committee on Science, Technology, and Law, The National Academies of Sciences, Engineering, and Medicine
Moderated by
J. Stephen Morrison
Senior Vice President and Director, CSIS Global Health Policy Center
Stanford is investigating Stephen Quake, a professor of biotechnology, because of his interaction with He Jiankui, the scientist behind the first gene-edited babies. “I hold myself to high ethical standards,” said Dr. Quake, who was once Dr. He’s academic adviser
Stanford is investigating Stephen Quake, a professor of biotechnology, because of his interaction with He Jiankui, the scientist behind the first gene-edited babies. “I hold myself to high ethical standards,” said Dr. Quake, who was once Dr. He’s academic adviser
PALO ALTO, Calif. — “Success!” read the subject line of the email. The text, in imperfect English, began: “Good News! The women is pregnant, the genome editing success!”
The sender was He Jiankui, an ambitious, young Chinese scientist. The recipient was his former academic adviser, Stephen Quake, a star Stanford bioengineer and inventor.
“Wow, that’s quite an achievement!” Dr. Quake wrote back. “Hopefully she will carry to term…”
High cost isn’t America’s only drug problem. The pharmaceutical industry has followed a brilliant two-pronged strategy to maximize its profits: raise prices and increase consumption of medications
High cost isn’t America’s only drug problem. The pharmaceutical industry has followed a brilliant two-pronged strategy to maximize its profits: raise prices and increase consumption of medications
Most of the attention has focused on just one side of the equation — prices. With politicians and advocates on both sides of the aisle vowing to lower drug prices, few people are talking about Americans being overprescribed medications, which not only adds to the cost of drugs but also harms millions of Americans each year.
The number of Americans taking multiple medications has grown rapidly over the last two decades. Between 2000 and 2012, the proportion of adults in the U.S. who were taking five or more medications nearly doubled, from 8.2 percent to 15 percent.
Some scientists have recently proposed a temporary moratorium on editing that would result in babies that carry heritable changes. Such a ban would last for perhaps five years to buy enough time to improve the technology and to allow for public debate (SN Online: 3/13/19) .
An advisory committee to the World Health Organization has alternatively proposed a global registry of work on human gene editing. Such a database would provide transparency and a better understanding of the state of gene-editing science, committee representatives said in a news conference March 19.
Science News talked with Nobel laureate David Baltimore, who is president emeritus of Caltech, about the ongoing debate. Baltimore, a virologist and immunologist, chaired two international summits on human gene editing. The interview has been edited for brevity and clarity.
The U.S. Food and Drug Administration plans to release a new definition for the term “healthy” this summer, Commissioner Scott Gottlieb said Friday at an event held by the Pew Charitable Trusts in Washington, DC
The U.S. Food and Drug Administration plans to release a new definition for the term “healthy” this summer, Commissioner Scott Gottlieb said Friday at an event held by the Pew Charitable Trusts in Washington, DC
The new guidelines will be closely watched by food companies that are eager to market their products as healthy. Consumers have largely gravitated toward the category in recent years — and away from items that are high in sugars and processed ingredients.
The agency announced in September 2016 that it would start collecting public comments on the definition, and it later extended the comment period. It ultimately received over a thousand submissions. The FDA also issued guidance clarifying which so-called healthy products could be subject to federal enforcement.
The current definition says the term can only be used if the product meets conditions for content of fat, saturated fat, cholesterol and other nutrients. Different levels are allowed depending on the item.
The international committee of 18 researchers and bioethicists, which met in Geneva, Switzerland, over the past 2 days, also agreed with the widespread consensus that it would be “irresponsible at this time for anyone to proceed with clinical applications of human germline genome editing.”
The international committee of 18 researchers and bioethicists, which met in Geneva, Switzerland, over the past 2 days, also agreed with the widespread consensus that it would be “irresponsible at this time for anyone to proceed with clinical applications of human germline genome editing.”
There’s an “urgent need” to create a transparent global registry that would list all experiments related to human genome editing, an expert committee convened to advise the World Health Organization (WHO) said today. The international committee of 18 researchers and bioethicists, which met in Geneva, Switzerland, over the past 2 days, also agreed with the widespread consensus that it would be “irresponsible at this time for anyone to proceed with clinical applications of human germline genome editing.”
The committee stopped short, however, of endorsing the call for a “moratorium” on human germline editing issued last week by prominent group of researchers in a Nature commentary. “I don’t think a vague moratorium is the answer to what needs to be done,” said Margaret Hamburg, a co-chair of the WHO committee who formerly headed the U.S. Food and Drug Administration and now works with the U.S. National Academy of Medicine in Washington, D.C., during a teleconference for the media today. Several other high-profile statements and reports on genome editing have also avoided using the word “moratorium,” although they have similarly emphasized that too many risks and unknowns still surround this technology to use it for germline modifications—which could alter sperm, eggs, or embryos in a way that could pass changes on to future generations—even if the modifications are aimed at preventing life-threatening diseases.