Brainstorm Health: NIH Virus Funding, Obamacare Mandate Repeal…

Hello, readers! This is Sy.

Would you take a deadly pathogen like the influenza, SARS, or MERS virus and make it even deadlier? Well, the National Institutes of Health (NIH) may, after a three-year hiatus, decide to fund your research. Which raises the question: Why?

The goal here is to “develop strategies and effective countermeasures against rapidly evolving pathogens that pose a threat to public health,” the NIH explains. That is, so-called “gain of function” research in pathogens may help scientists anticipate how viruses may spread and evolve, and therefore how to stop them from leading to unmanageable pandemics. The NIH’s funding pause on such studies went into effect in October 2014 but has now been lifted.

Still, the very idea likely sounds like a horror movie—which is why the NIH has listed out detailed criteria for what kind of lethal virus research would make the cut for government funding. “We have a responsibility to ensure that research with infectious agents is conducted responsibly, and that we consider the potential biosafety and biosecurity risks associated with such research,” said NIH director Dr. Francis Collins in a statement. “I am confident that the thoughtful review process laid out by the HHS P3CO Framework will help to facilitate the safe, secure, and responsible conduct of this type of research in a manner that maximizes the benefits to public health.”

For instance, the research would have to be both ethically and scientifically justified. You can’t just go around enhancing any old virus; it would have to be one that feasibly poses a threat to humans. And institutions involved in conducting such studies would have to prove they have the technology and protocols to carry it out safely.

Pandemics like the 2014 Ebola outbreak, or the wildfire spread of MERS, SARS, and flu are difficult to contain once they’ve already infiltrated human population centers—which is why global health experts have urged new research and incentive models to prevent pandemics from occurring in the first place. Making lethal viruses deadlier in a controlled setting could be one part of that effort, in the NIH’s eyes.

Read on for the day’s news.

Sy Mukherjee

@the_sy_guy

[email protected]

DIGITAL HEALTH

Gene editing fixes deafness in mice. In the latest advance for CRISPR gene-editing, scientists have for the first time been able to prevent hearing loss in mice by fixing a defective gene. Howard Hughes Medical Institute's (HHMI) David Liu and his team used CRISPR-Cas9 to snip out the "bad" Tmc1 gene copy in mice and successfully prevented them from going deaf. The long-term implications? "We hope that the work will one day inform the development of a cure for certain forms of genetic deafness in people," said Liu.

INDICATIONS

Huge new GAO report highlights pharma's profits and expenses. The Government Accountability Office (GAO) is out with an extensive new report examining pharmaceutical companies' profits, R&D costs, and M&A trends. Some standout numbers: "Sales revenue increased from $534 billion to $775 billion between 2006 and 2015. Additionally, 67% of drug companies increased their annual profit margins during the same period—with margins up to 20 percent for some companies in certain years. Drug industry spending for research and development increased from $82 billion in 2008 to $89 billion in 2014." Another tidbit: "Among the largest 25 [drug] companies, annual average profit margin fluctuated between 15 and 20 percent. For comparison, the annual average profit margin across nondrug companies among the largest 500 globally fluctuated between 4 and 9 percent." The entire report is worth perusing. (GAO)

Gene therapy upstart Orchard raises $110 million. Gene therapy has been the name of the biotech game in 2017, and another firm is raising mounds of cash to develop treatments in the field. Orchard Therapeutics on Wednesday announced a $110 million second funding round to help it launch and manufacture a gene therapy treatment for a rare inherited disorder. Just yesterday, the FDA approved the first directly-administered gene therapy in the U.S., Spark Therapeutics' Luxturna to treat a form of blindness. (Reuters)

THE BIG PICTURE

The GOP tax plan passes along with Obamacare mandate repeal. The GOP's tax bill has officially passed Congress and will momentarily be signed by President Donald Trump. It includes a repeal of Obamacare's individual insurance mandate. If you're confused about how that might affect you, I have an explainer up here. Health care bills that are still up in the air at this point include: a pair of Obamacare fixes Maine GOP Sen. Susan Collins says she has been promised; and renewal of the Children's Health Insurance Program (CHIP), which covers 9 million children in low- and middle-income families. Congress may not renew CHIP until next year, after the holidays, while 25 states would likely run out of CHIP funding and begin denying coverage to children if the program isn't reauthorized by the end of January. (Coins2Day)