Medical Device Daily Washington Editor

A little flag-waving takes place in a lot of political debates, but it sometimes shows up in the oddest-seeming places, such as in discussions of the budget for the National Institutes of Health. And of all the healthcare debates in the U.S., the debate over NIH funding is perhaps the closest to a non-debate, with virtually no voices arguing that the agency is over-funded.

So it comes as no surprise when another report comes out urging further increases to the NIH budget. But the competitive position argument, which makes the case that the U.S. absolutely must maintain its lead in biomedical research, still has no supporting data.

According to a statement released last week by Research!America (RA; Alexandria, Virginia), “total U.S. investment in health-related research grew by a modest 4.2% from 2005 to 2006, significantly slower than the 6.8% increase in U.S. health costs.” RA published the statement to coincide with the publication of its article on the topic in the Aug. 31 edition of Science.

According to the numbers compiled by RA, the total investment into medical research and development (R&D) in the U.S. was about $116 billion in 2006, which the authors describe as “a decrease relative to total health costs.” Their numbers indicated that for every dollar spent on health overall, slightly more than 5 cents “went to research in 2006, the smallest portion since 2001.” This, the authors assert, “continues a trend that started in 2005, following a flattening in federal research spending that began in 2004.”

The RA numbers indicate that R&D investment by industry, “which has for several years exceeded federal sources, increased only slightly from $61 billion in 2005 to $64.5 billion in 2006.” The report also states “this growth is overshadowed by the fact that a leveling out of public funding has in the past led to a leveling out of private funding.”

Other sources of funds for such research – including universities, independent research institutes, voluntary health associations, foundations and state and local governments – boosted their spending from just under $13 billion in 2005 to $13.7 billion in 2006.

The report also says: “In light of the looming challenges to our nation’s pre-eminence in research, now is the time to accelerate investments.”

John Edward Porter, the former Congressman from Illinois who championed NIH in the House throughout most of the 1990s and is now the chairman of RA, said in the statement that “[‘t]he importance of federal research investment in priming the pipeline for other sources of research funding cannot be underestimated.” (It is assumed that Porter intended to say “overestimated.”)

Porter said that the nation’s competitive position in medical research is at risk “if federal funding does not keep pace at least with biomedical inflation.” Porter is also a partner at the DC law firm of Hogan & Hartson.

However, the report offers no comparative figures with the healthcare R&D budgets of other nations, let alone a justification as to why the U.S. should shoulder the vast majority of the financial burden for advancing healthcare into the future.

Stacie Propst, PhD, senior director of science policy and the lead author of the study, told Medical Device Daily that she was not aware of any comparative numbers and did not seek to include such data.

“Other countries don’t necessarily track” such data, she said, although she added that the Organization for Economic Cooperation and Development (Paris) may have that information.

However, Propst acknowledged: “We are pretty far ahead of everybody in terms of R&D,” adding that the amount of private-sector R&D in Australia and Canada, for example, amounts to “very little.”

On the other hand, “there’s really no doubt that investing in innovation has helped to turned us into the largest economic power in the world,” Propst said.

Asked whether everyone in the world would be better off if the R&D load was more evenly distributed across technologically capable nations, Propst said: “Absolutely. The better off other countries are, the better off we are.”

Propst was in no hurry to take on the idea of comparing the return on investment (ROI) for medical research to that of other pursuits, such as energy, but argued that medical research “has an amazing payoff and certainly a better way of life for American citizens.” But the national budget “is way too complicated for us to take on” the comparative ROI question, she added, echoing a sentiment others inside the Beltway have shared recently.

Despite her reluctance to grapple with the ROI debate, Propst was supportive of better funding for FDA. She said that FDA’s “mandate is larger than their funding,” but noted that “there are now in place some real advocates for FDA.

“It doesn’t do you much good to have a great idea and not be able to then use it. Sometimes the lag time is too long” for drugs and devices, she said.

Where overall healthcare costs are concerned, Propst said the current configuration of healthcare in the U.S. incurs “an incredible amount of inefficiency, which has created a lot of profits for a lot of people.” As an example, she cited healthcare information technology (HIT) as a pivot point for transforming healthcare into a leaner, more effective sector of the economy, but acknowledged that those in the private sector have little reason to junk their current HIT systems just yet, and that the web sites for FDA and CMS are hardly reasons for optimism about the idea of putting HIT into the hands of the federal government.

Propst said that some of the NIH budget could be steered toward behavioral change to great benefit, saying that “the savings are going to be astronomical” if preventive care ever lives up to its promise. However, she made the case that the balance between genetics influences and the impact of diet and exercise is not particularly well understood, despite the case of the Pima Indians.

The Pima tribe is split between Mexico and the U.S. Southwest, primarily Arizona. A well-known analysis conducted in the late 1990s confirmed that the genetics are not meaningfully different between these two “branches” of the tribe, but obesity and diabetes among the tribe’s members in the U.S. far outstrip that of their cousins in Mexico.

Propst said “the obesity problem is not just a behavioral problem, it’s environmental as well,” adding that fresh fruits and vegetables are much more expensive than junk food in urban areas. Still, she acknowledged that she would “never say there shouldn’t be more behavioral research,” noting that the Framingham Heart Study is how scientists “figured out that cigarette smoking is bad and cholesterol is a marker or heart disease.”