Researchers transforming animals with the latest genome-engineering tools may be disappointed by draft rules released by the US Food and Drug Administration (FDA) on 18 January — two days before US President Barack Obama leaves office. It is not clear how the administration of incoming president Donald Trump will carry the proposals forward, however.
The most controversial of three proposed regulations declares that all animals whose genomes have been intentionally altered will be examined for safety and efficacy in a process similar to that for new drugs.
Many researchers had hoped that the FDA would be less stringent about evaluating organisms whose genomes have been edited with precise tools — such as CRISPR and a separate technique called TALENs — than it is for animals that have been given DNA from different species or created using less-sophisticated means. Alison van Eenennaam, an animal geneticist at the University of California, Davis, calls the draft FDA proposals “insane”.
“The trigger for their regulation is whether the animal was intended to be made, and what does intention have to do with risk?” she says. “The risk has to do with the attributes of the product.”
BETHESDA, Md. — At what was supposed to be the end of his tenure atop the National Institutes of Health, Dr. Francis Collins is still a very busy man.
In his seven and a half years leading the agency, Collins has been involved in the response to Ebola and Zika. He has helped secure the first funding increases for the NIH in decades. Congress just this month funneled billions of dollars into several major projects — the Precision Medicine Initiative, the cancer moonshot — that Collins helped craft.
This was supposed to be the finale for Collins. But, as he told STAT in a recent interview in his offices here, he loves the NIH and believes in public service, so if asked he would consider it a “privilege” to remain director under President-elect Donald Trump. Many researchers and members of Congress would like to see him stay. Nobody knows yet if he will.
Below is his full conversation with STAT, in which he reflects on NIH's past and future. The transcript has been lightly edited for clarity and length.
Tell us about a few programs that you are most excited about.
As far as areas of exceptional opportunity, I’d start with the Precision Medicine Initiative. This unprecedented national study of health has recently been renamed and now it is called "All Of Us."
African-Americans often say no to clinical trials. Our reporter asked her mom 'Why?'
All the big-name medicines you know about are tested for safety and effectiveness before they reach the pharmacy shelf. And before that hundreds or thousands of people had to agree to participate in the clinical trial. It's how researchers find cures.
However, women, people who live in rural communities, older adults, and members of ethnic and racial minorities are often missing from those studies. That means some of those blockbuster medicines could have an asterisk on the label that says: "Tested on middle-age white guys, but we're hoping it helps you too."
In particular, there's a big, indisputable, "so-called" truth that it's especially hard to get African-Americans to sign up for clinical trials. It's complicated, of course, because it's not clear that black people are being asked to volunteer in ways that are effective. Add to that: Hesitation among African-Americans is a subset of a national ambivalence about volunteering for medical research. Just 35 percent of all Americans are likely to enroll in a clinical trial, according to a survey from the Sloan Kettering Cancer Center in New York.
It wasn't too long ago that including "LGBT" in a health research funding proposal could get it thrown out, said LGBT health researcher Kellan Baker.
"LGBT health has traditionally been treated as disposable," said Baker, a senior fellow at the Center for American Progress.
But a recent announcement from an institute within the National Institutes of Health shows a shift in that attitude, and lends federal recognition to the health challenges faced by those who identify as lesbian, bisexual, gay, transgender, or otherwise outside of traditional gender norms.
The National Institute of Minority Health Disparities (NIMHD) this month classified sexual and gender minorities as a health disparity population that is, a group whose health is significantly worse than the general population in terms of disease and mortality. Baker, who regularly meets with the NIH on issues of LGBT health policy, said that the Center for American Progress has been pushing for this classification for almost a decade.