With not enough funding to go around, young (and some old) innovators are being swept aside for supposedly "tried and true" researchers and scientists. Who decides this and at what cost to society?
By Kathleen Phalen Tomaselli
In Virginia, a small company has developed a serotonin blocker that deters alcoholics from wanting to drink. It sits on the shelf awaiting funding for its next level of required testing.
In California, as The Fix reported earlier this week, a vaccine for heroin addiction that in animal tests completely blocks the drug from reaching the brain, languishes in the laboratory without support.
Meanwhile, research funding for hugely promising alternative addiction treatments such as neurofeedback technology and NAD (massive doses of a Niacin derivative) is barely in the game. And forget about promising studies of socialized animal and human behavior modes that tend to prevent addictive behavior in the first place. Or deeper research into tobacco addiction, or validation that drug harm-reduction programs seem to be working so well in a NYC non-profit rehab center.
Most of us understand that substance addiction and alcoholism is a major social, health, and economic issue. The costs to the economy alone in health care, productivity loss, crime, drug enforcement and incarceration are estimated to be more than $500 billion a year - and that number is from a study ten years ago. In response, only a tiny percentage of this is spent every year by all players - government, private Pharma companies and foundations - on developing and testing a variety of would-be miracle cures (or even just helpful medications or processes).
In the substance abuse funding game there are gamemakers - those who decide which projects are worthy of the awarded dollars - and competitors: researchers vying for limited funds. The gamemakers come from the public and private sector and ultimately determine whether a competitor moves forward or gets denied.
This article is an inside peek at how that game is played and who gets to be the winners and who the losers.
THE BIG PICTURE
First, it’s folly to think that every brilliant idea gets funded. What’s more, it may take decades for a scientist’s theory to take flight. Some projects, inventions or new discoveries will forever remain scribbled tomes given the realities of how the human species wants to spend its money.
According to the report "Ending the Drug Wars," released May 7 by the London School of Economics Expert Group on the Economics of Drug Policy, “In spite of a significant body of evidence that drug-related health services are a very good investment for society, they remain woefully underfunded and unavailable.”
In today’s cash-strapped research arena, it is the novel ideas that most often are relegated to the slush pile of the never-funded.
“Funding is in a bad situation," says Keith Humphreys PhD, professor of psychiatry at Stanford University. “The NIH (National Institute of Health) generally funds about 90% of all the world’s addiction research. And the NIH is straining under the fiscal environment. It’s particularly tough for younger investigators when there is a decrease in available funds.”
Statistically, with epidemics of addiction to heroin, meth, prescription drugs and designer drugs playing havoc in various areas of the country, much less the world, there has never been a greater need to fund innovative research and novel concepts related to substance abuse. And there’s the rub. With much at stake in the research funding game - careers, political policies and amounts of funding dollars - players from every quarter are struggling with each other for position and voice, including organization leaders, scientists, activists and politicians. As a result, conflicting ideologies, intense competition and narrowly held perspectives are holding research dollars hostage… and innovation at bay.
Let’s look at the federal programs. The largest, the National Institute on Drug Abuse (NIDA), part of the NIH, is working with a drastically reduced budget - 25% less than a decade ago. In 2013 researchers vied for their part of a $141.3 million actual 2013 budget. Until 2003 the NIH research budget was rapidly doubling but flattened out until 2008 when the Great Recession forced a dramatic tightening just as substance abuse was spreading. Demands for research dollars soon far outpaced what was available.
In this tight climate, NIDA has opted for caution and familiarity over innovation. Seasoned scientists have been given the advantage in competition, with a greater percentage of the purse now going to those with a solid research history, placing more dollars in fewer hands. “There is concern across the board in the research arena with a decreasing budget,” says Jack Stein, PhD, director of NIDA's Office of Science Policy and Communications. “There is no doubt: those with experience have a better edge…unfortunately wonderful grant requests have come in that could not get funded because of budgets.”
The National Institute on Alcohol Abuse and Alcoholism (NIAAA) has an even smaller budget: Out of 530 applications last year, 166 were funded for $55,291,978.
Some history: Federal money for research was plentiful after World War II. And until the 1980s, scientists found support and funding for novel ideas. Take Jim Topolski, PhD, research associate professor at the Missouri Institute of Mental Health, a unit of the University of Missouri, St. Louis.
Back in the mid-1980s Topolski worked for the Missouri Department of Mental Health. There was little competition for grants. While his first grant request - to study substance abuse services for the homeless - was not funded, his second, which was aimed at reducing waiting times for people with AIDS who needed substance abuse treatment, was awarded funding. Over the years he has been successful with many of his grant requests, especially with funds from The U.S. Dept. of Health's Substance Abuse and Mental Health Services Administration (SAMHSA).
These days Topolski, like others, finds himself competing for less money from both SAMSHA and NIH.
Another segment of funding derives from private research dollars. These come from private foundations, investors, pharmaceutical manufacturers and the alcohol industry. Biopharmaceutical research companies - working in collaboration with academia, government researchers, and patient organizations - have 20 new substance abuse drugs or vaccines being considered for financing, according to a report released in May by the Pharmaceuticals Research and Manufacturers of America Assn (PhRMA), an industry advocacy group.
One drug hungry for financing is AD04, licensed by ADIAL in Charlottesville, VA. A serotonin blocker, it has shown in Phase II trials of 283 patients to dramatically reduce the craving for alcohol. AD04 was initially studied at the University of Virginia and University of Texas and funded through the NIAAA. Then ADIAL licensed the technology. “We’re a small biotech pharmaceutical manufacturer,” says William Stilley, CEO. “We raised under $10 million initially. We are ready to go into Phase III trials, and we are seeking funding.” Stilley says the company will most likely be a financial or strategic partner. “It is getting harder and harder to get funding.”
Those frustrated with research funding ask: what about funding more grants with less money? Would there be room for new ideas? Without it, what happens to innovation given that there is hardly a way for creative approaches to demonstrate effectiveness without funds to produce peer-reviewed studies?
The gorilla in the room around this question turns out to be the ideology of the decision makers. “There are ideological constraints tied to what gets funded," says Ethan Nadelmann, founder and executive director of the Drug Policy Alliance in New York City. An example? The tendency to fund "abstinence only" programs and the war on drugs at the expense of drug prevention research. "There is not a lot of evidence of what works because it does not get studied. Today, kids lose their drug virginity before their sexual virginity. What’s the needle exchange of today?"