Seeing through the smoke with the help of research: a conversation with Helen Meissner

{credit}NIH{/credit}

Most people stopped doubting the dangers of tobacco long ago. And yet, tobacco products continue to adorn the checkout kiosks of convenience stores and appear in the pages of magazines. The question is: which of these products should be allowed and which should not? It’s no longer a theoretical question: the US Food and Drug Administration (FDA) was granted the power to regulate these products four years ago.

More research will help the FDA make tough decisions in this area, says Helen Meissner, the director of the Tobacco Regulatory Science Program at the US National Institutes of Health (NIH). Meissner is leading a joint effort with the FDA to study how to bring science-based regulation to the manufacturing, marketing and distribution of products such as cigarettes. On 19 September, the two agencies announced that they would grant a total of $53 million to 14 research teams working on tobacco-related projects across the US. Nature Medicine asked Meissner about the newly formed Tobacco Centers of Regulatory Science (TCORS) and the challenges of government-funded research in this space.

What are the biggest research goals of this new funding effort, broadly speaking?

The FDA [needs] to understand tobacco products in order to review tobacco products. They need product standards. They need to know how best to monitor compliance and enforcement, say with advertising or youth access. And they also need information on the best ways to communicate about tobacco products through media and education campaigns.

And how will the 14 centers come together and communicate?

They will be coming together through grantee meetings, so there will be collaborative activities across the centers. Although each is independent and they have different seams—as I mentioned they cover different areas—there is synergy as well across the centers. So that is the role of NIH: to convene the groups.

Continue reading →

US budget cuts imperil domestic and global biomedical research

{credit}Shutterstock{/credit}

In the medical world, the term ‘sequestration’ is usually preceded by the word ‘pulmonary’ or ‘splenic’ and is used to describe rare diseases that are the focus of research grants funded by the US National Institutes of Health (NIH). But sequestration has now taken on a new meaning.

On Friday (1 March), a series of sweeping federal budget cuts totaling more than a trillion dollars over the next ten years are scheduled to automatically go into effect unless a legislative bargain is reached—and their impact on biomedical research could be dire, with consequences felt both in the US and abroad.

“We are going to maim our innovation capabilities if you do these abrupt deep cuts at NIH,” former agency director Elias Zerhouni, now head of global R&D at the French drug company Sanofi, told the Washington Post. “It will impact science for generations to come.”

The NIH, already suffering through half-a-decade of stagnant funding, will receive a 5.1% cut across the board—a reduction of $1.5 billion from a total budget of $31 billion. Should this happen, the agency’s operation plan is straightforward: fewer projects will get new funding and existing ones will be supported at lower levels. “Cuts will result in slower progress against our most common diseases, such as Alzheimer’s, cancer, AIDS, diabetes and heart disease,” Francis Collins, the NIH’s current director, said at a press conference addressing sequestration last week.

United for Medical Research, a coalition of universities, biotech companies and research associations, estimates that cuts to the NIH budget could lead to 20,000 fewer jobs and a $3 billion economic impact this fiscal year. Potentially more troubling is the effect of sequestration on new researchers. Lower success rates for NIH grants, which have steadily declined since their peak in the early 2000’s, could stall the careers of young investigators. Even training grants, which fund graduate students at universities, are at risk of being cut, said Collins. “This is not a spigot you turn off and turn back on later. If we lose the talents of this up and coming generation, they’re not coming back,” he said.

Although the NIH is the single largest funding source for biomedical research, other agencies—including the Food and Drug Administration, the Agency for Healthcare Research and Quality, the Department of Defense, the Centers for Disease Control and Prevention, the National Science Foundation, and the Agency for International Development—would all receive sequestration cuts.

Combined, the US agencies are the largest funder of research in the world. Their significant contributions to global health and the potential harm sequestration could cause are highlighted in a report released today by the Global Health Technologies Coalition, a group of nonprofit organizations.

With the development of potential HIV preventatives, improved malaria drugs and other global health products, US government research funding has already saved millions of lives and provided economic benefits around the world. If the research pipeline were to be interrupted now, scientific regression, increased long-term costs and needless deaths would result, the report argues. “There is much to lose by pulling back now,” the authors write.