How biomedical research fails the nation why no one cares

nih scientistYesterday I detailed how the claim by NIH director, Dr. Francis Collins, that with more money an Ebola vaccine would have been developed was patently nonsense. In an annual budget of nearly $30 billion, a paltry $12 million a year, which is roughly equivalent to what Lindsay Lohan spends on blow, was earmarked for Ebola vaccine development. While the comment by Collins was ass-covering hyperbole and a fairly transparent attempt to turn an institutional failure into a financial windfall, it is important to understand how a situation like this comes to pass.

On January 17, 1961, as his second term was coming to an end and only three days before the inauguration of John F. Kennedy, President Dwight D. Eisenhower gave a speech that he probably thought of as his version of Washington’s Farewell Address. Like most presidential speeches, it is pretty forgettable stuff. But it did leave us with a turn of phrase that we still hear with regularity:

In the councils of government, we must guard against the acquisition of unwarranted influence, whether sought or unsought, by the military-industrial complex.

This refers to the collaboration between the military and industry to ensure a constant flow of money into defense procurement, whether or not it is needed. This is not what Eisenhower wanted to say.

The actual drafter of the speech, Ralph E. Williams, relied on guidance from [Johns Hopkins professor of political science, Malcolm] Moos. Milton Eisenhower explained that one of the drafts of the speech referred to the “military-industrial-Congressional complex” and said that the president himself inserted the reference to the role of the Congress, an element that did not appear in the delivery of the farewell address.

When the president’s brother asked about the dropped reference to Congress, the president replied: “It was more than enough to take on the military and private industry. I couldn’t take on the Congress as well.”

Properly understood, science research funding looks very much like Defense procurement, except it operates in a self-dealing way that would not survive public scrutiny in any other procurement operation. Where Eisenhower indicted the military-industrial-Congressional complex, the nation would be well served in examining the public health bureaucracy-research-Congressional complex that controls funding of biomedical research.

Though the CDC and NIH have in-house, known as intramural, research capabilities the lion’s share of research is carried out by educational institutions. If you consult the NIH funding database you find that some 491 colleges and universities have received NIH research grants. In fiscal year 2014, these grants, shared between 490 colleges and universities, total $16,561,972,196 (that is billion with a b) and fund 39,433 projects. There are other research grant and contract recipients but for this essay I am only going to focus on the educational part of the grant recipient pie.

Congress

The role Congress plays is to provide the play money to NIH. Congress loves it some science. Congressmen love the colleges and universities in their districts. No one wants to vote against an NIH budget because that makes you anti-science and kids die. This is not a thing. Neil DeGrasse Tyson will manufacture bogus quotes to belittle you and Democrat activists will make ads showing the very faces of the kids you killed. In fact, where the Iron Triangle of Congress-Bureacracy-Research is stronger than the military-industrial complex is that is has no natural enemies. No one will ever produce a bumper sticker that says “It will be a great day when our schools get all the money they need and the NIH has to hold a bake sale to find out why lesbians are fat.”

Where Congress takes an active interest in the number and types of widgets being designed and bought by the Pentagon, the research priorities of NIH are not directed by much of anyone at all.

Public Health Bureaucracy

In this respect, the public health bureaucracy ensconced under the HHS umbrella, but primarily represented by NIH, acts very much like the military services in procurement. The various institutes and centers that make up the NIH and CDC tend to be parochial. There is precious little in- or out-migration which produces senior managers thoroughly embalmed by institutional prerogatives and “the way we’ve always done it.” When senior managers are hired from the outside, they are usually researchers who have a long history of winning NIH grants. You aren’t going to find a General Billy Mitchell in the NIH for the same reason you don’t find them in the armed forces.

The idea of having institutes and centers devoted to diseases makes sense. It also causes stovepipes. Within institutes there are other stovepipes so related diseases have different funding streams. A lot of talk is paid to collaboration but, in reality, research is approached through a lens of disease. Everyone knows this and it affects the research that is funded. A research proposal totally within one organization has a better chance of funding than a proposal that cuts across organizations.

Money is also power. The more money you have to dispense the more important you are. The more boards and committees you sit on. The more business opportunities that are put in your way. Plus you are being sciency and not killing kids. In short, you ARE Neil DeGrasse Tyson.

Research

This is clumsy wording because there are two key components and I’m not literate enough to find one word to pull them together. The two parts are research universities, who manage research funds, and researchers, who compete for and execute NIH research grants. As I noted above, this is big business. This is not Dr. Brainard inventing Flubber. As George Orwell wrote, “All animals are equal, but some animals are more equal than others.” This perfectly describes the research grant ecosystem. It applies equally to institutions and to researchers.

While there are 490 colleges and universities receiving NIH research grants, the top 26 win over 50% of all money. In contrast, the bottom 26 get 0.012%. Ten percent of the grant budget is spread between 379 institutions.

nih univ

Rather than being a broadbased program for funding research, a small number of universities and individual researchers receive enormous amounts of money.

The money, keep in mind, doesn’t totally pay for research. A majority, I say again, a majority of the research money goes to the institution in the form of “indirect expenses.” For instance, 69% of the research money awarded to Harvard never gets within spitting distance of a lab or a scientist. It is raked off the top for expenses associated with running the research operation. For fiscal year 2011, the data looks like this:

nih overhead

So universities have a financial stake in keeping the research dollars flowing. Yes, there is a cachet attached to making discoveries but more importantly it provides a funding stream to subsidize the university.

There are two general categories of research within NIH. Research directed by the NIH or its institutes and centers for a specific research need and research proposed by individual researchers (the term used for these people is “investigator”). Very little money is spent on directed research. The lion’s share goes to the life’s blood of academia, the RO 1, investigator initiated research. Why, you may ask, would not the scientific bureaucracy that oversees biomedical research not have a better idea of what needs to be done? Well, it might. Often it does. But members of Congress respond to large universities complaining about this and the path of less resistance is taken. Why, again, you may ask would anyone object to this? Well, submitting a proposal on a directed research project tends to make all the animals equal. The unequal animals don’t like that.

The final thing to understand about how the structure of the award process produces the research results is the process by which grants are awarded. Less than 20% of grant applications will be funded. The average age at which an investigator wins his or her first NIH grant is about 40 (it varies slightly across NIH). For those who think getting a Ph.D. in biomedical science is a good idea, consider finishing your Ph.D. and working for the next decade and a half as a gypsy bouncing from post-doctoral fellowship to post-doctoral fellowship and making south of $40,000 per year. And never finding a tenured position.

Grants are awarded based on a process of peer review. In short, researchers who have NIH grants in a particular area are selected to review grant proposals and assign a numerical rating. Magic happens.  The numbers are converted to what in the military is called an order of merit list, from highest score to lowest, and the projects are funded until money runs out.

The potential for abuse is enormous. Do you know the proposal author and loathe him? Are you sleeping with the author? Which institution does the proposal come from? Gee, this looks cool, I think I’ll sandbag this guy, take his proposal and submit it myself. Keep in mind that funding is a zero sum game. Every dollar that you vote to award to someone else is not available for you.

Columbia University ($306 million in grants, overhead rate of 60$) has an interesting discussion on peer review. One of the headers tells the story:

A peer reviewer must preserve scholarly integrity by rising above the three deadly sins of intellectual life: envy, favoritism, and the temptation to plagiarize

Here are some of the questions touched upon:

  • Are there tendencies not to publish papers or award grants to colleagues you don’t particularly like?
  • Are there prejudices against younger investigators or older, established ones?
  • How do you hold at bay any desire not to award grants to competing institutions?
  • Are there inclinations to overcompensate and look excessively favorably on one’s rivals?
  • How do you resist temptation to take results from colleagues or competitors?

So, in a nutshell, if you want to know how we spend about $30 billion per year on biomedical research and we don’t have an Ebola vaccine, the answer is easy. No one has a vested interest in doing the research. Our research budget is essentially on auto-pilot and, to the extent that it operates with any direction whatsoever, it responds to the wants, needs, and desires of large universities and prominent researchers. little resemblance to

I don’t have the answer. Large research universities are the logical focus for biomedical research. And at some point, someone has to decide what to fund. Should that be scientists? Or Congressmen?  One defender of peer review uses Churchill’s description of democracy:  the worst form of government except all the others that have been tried. That may be true. There must be, however, some middle ground where research reflects the biomedical research needs of the nation not the interests of powerful institutions. Where research for a vaccine for a fatal disease is given priority over producing a supply of svelte lesbians.