Showing posts with label NIH. Show all posts
Showing posts with label NIH. Show all posts

Friday, November 16, 2012

NIH Director Calls Off NIDA-NIAAA Merger


Nation’s addiction research institutes to remain separate but unequal.

Two years ago, the National Institutes of Health’s Scientific Management Review Board (SMRB) issued a report recommending that NIH move to establish a new institute focused on substance use, abuse, and addiction-related research to optimize NIH research in these areas. The idea was to combine the two existing addiction research agencies: the National Institute on Drug Abuse (NIDA) and the National Institute on Alcohol Abuse and Alcoholism (NIAAA). Skeptics like myself wondered if it would ever happen.And now we have our answer—no, it’s not going to happen. (NIH'S Collins)-->

Score one for the alcohol researchers, who mostly opposed the merger from the start, viewing it as more of a hostile takeover. NIAAA has always been the weaker sister in the addiction research family. With only half of NIDA’s billion-dollar budget, NIAAA deals strictly with alcohol research, even if the NIAAA has at times seemed unsure of what constitutes its main area of study—alcohol the addictive drug, or alcohol the healthy beverage. The merger would have represented a recognition that alcohol is just another drug, albeit a legal one.

It was an obvious thing to do. Former NIH director Harold Varmus had complained that the sprawl was hobbling NIH’s ability to “respond to new science.”

However, in a Science (sub req) interview that year,  Francis Collins, the current director of the NIH, said: “I guess most people would have said, ‘Well yeah, of course.’ But when you look at the details…. and you consider that alcohol is after all a legal substance and 90% of us at some point in our lives are comfortable with taking it in while the drug abuse institute is largely focused on drugs that are not legal. So there's a personality of the institute issue here that people thought might be important to preserve, others thought would be good not to preserve.”

It did not take long for the fraternity of alcohol researchers to view the potential move with alarm. Acting NIAAA director Dr. Kenneth Warren offered up what has come to be seen as the basic counter-argument: “The best way forward is a structure that increases collaboration all across NIH… nothing is gained by structural merger.” Warren said he favored “a separate, but equal” pair of agencies. “Alcoholism is a much broader issue than simply addiction.” 

Here is where it starts to get tricky. The assertion that alcoholism is not simply an addiction distills the disagreement down to its essence, which can be found not so much within the arena of science as within the arenas of morality, ethics, and the law.

On Friday, the traditional time for troubling news announcements in the media world, the NIH released its statement  from Director Collins: “After rigorous review and extensive consultation with stakeholders, I have concluded that it is more appropriate for NIH to pursue functional integration, rather than major structural reorganization, to advance substance use, abuse, and addiction-related research.”

Collins added: “The time, energy, and resources required for a major structural reorganization are not warranted, especially given that functional integration promises to achieve equivalent scientific and public health objectives.”

 But the smooth and cost-effective advance of addiction science may have met a stumbling block in the director’s refusal to do the obvious, and streamline the crucial research on drugs and addiction performed by the nation’s premier medical research agency, the NIH. As one observer commented,  there are rumors that “the alcohol beverage industry is lobbying Kentucky politicians, including U.S. Rep. Hal Rogers, chairman of the House Appropriations Committee, to keep the institutes separate because it doesn’t want alcohol to be associated with cocaine.”


Tuesday, September 18, 2012

Alcohol Researchers Still Wary of Combined Addiction Institute

 
Why can’t we all just get along?

A long time ago, an intrepid institutional director named Francis Collins promised his minions (as former NIH director Harold Varmus had promised his) that he would unite the nation’s two mighty addiction research bodies, The National Institute on Drug Abuse (NIDA) and the National Institute on Alcohol Abuse and Alcoholism (NIAAA), for the greater good of the entire kingdom—researchers and taxpayers alike.

Hasn't happened yet. 

Existing within the large institutional framework of the National Institutes of Health (NIH), the two agencies overlap sufficiently to make them prime candidates for a consolidation. Advocates of the merger, most of them advocates for NIDA, also suggest that the research itself will improve as a result of a decrease in “overlapping missions.”

However, as I wrote in 2010, the NIAAA has a long list of reasons why the merger—which looks, from the NIAAA point of view, more like an acquisition—is a bad idea. Alcohol use disorders are different than other drug addictions, researchers at NIAAA commonly propose. The genetics of alcoholism differs from the genetics of drug addiction, they say, and most people with “alcohol use disorders” don’t abuse other drugs. Furthermore, alcohol damages the brain and other organs in a consistent pattern “best suited to a single alcohol institute,” according to the NIAAA’s acting director.

At this stage, NIAAA’s heel dragging is patently obvious. The agency has always been the weaker sister in the addiction research family. With only half of NIDA’s billion-dollar budget, NIAAA deals strictly with alcohol research, even if the NIAAA has at times seemed unsure of what constitutes its main area of study—alcohol the addictive drug, or alcohol the healthy beverage. The merger would represent a recognition that alcohol is just another drug, albeit a legal one.

In a recent issue of Addiction Professional, Alison Knopf writes that “the alcoholism research field, which believes it would lose out under such a definition, is still fighting the reorganization. And some openly question whether the ‘merger’ ever will come to pass at all.”

Among the many unanswered questions are these, says Knopf: "The current portfolios for AIDS, fetal alcohol syndrome (FAS), liver disease and smoking—where the most money is at the two institutes—may or may not stay within the new institute. Also unknown to many is whether the new institute will cover all addictions (including those such as food and gambling) or will be devoted to the health effects of alcohol and drugs only."

The dark mutterings among alcohol researchers get even more specific in Knopf’s article. In one scenario, Fetal Alcohol Syndrome (FAS) “would go to the National Institute of Child Health and Development, liver disease and the entire organ damage portfolio would go to the National Institute of Diabetes & Digestive & Kidney Diseases, and cancer-related research would go to the National Cancer Institute (NCI). What would happen to drunk driving research is still unknown.”

Furthermore, “NIDA is worried about losing its AIDS funding, because it represents one-third of the institute’s budget.”

The NIH Substance Use, Abuse, and Addiction (SUAA) task force continues to wrestle with the question, which was originally to be decided by the end of the year. In the end, Knopf writes, one persistent rumor has stayed alive: The notion that “the alcohol beverage industry is lobbying Kentucky politicians, including U.S. Rep. Hal Rogers, chairman of the House Appropriations Committee, to keep the institutes separate because it doesn’t want alcohol to be associated with cocaine.”

Graphics Credit: http://www.puzzlemachine.com

Sunday, June 17, 2012

NIDA’s Volkow Defends New Medications for Addiction


On Big Data, Big Vaccines, and a Big New Agency.

In her Director’s Report to the 2011 meeting of the College on Problems of Drug Dependence in San Diego last week, Dr. Nora Volkow, director of the National Institute on Drug Abuse, sought to refute allegations that NIDA lately has been too focused on pharmacological approaches to treating addiction—“magic bullets” in the form of pills or vaccines. Dr. Volkow presented figures showing, as the CPDD Community Website reported, that “NIDA funding allocation for new medication development has remained stable at about 12% for some time, despite concerns expressed by some researchers that funding in other areas is being sacrificed to support the medication development portfolio.” Basic and clinical neuroscience research accounts for 45% of expenditures, she said.

In other news, Volkow expressed her avid interest in the possibilities presented by so-called “big dataset science”—the act of pooling together huge amounts of data in order to generate greater statistical power. She traced a set of disciplines—genetics, epigenetics, proteomics, brain imaging, clinical data, and systems biology—and said that the NIH’s Working Group on Data and Informatics  was seeking systematic ways of integrating and analyzing large biomedical datasets in these crucial areas.

As for treatment, the current emphasis is on stimulants. Volkow said that work continues on finding reliable antagonist drugs to combat the dopamine disruptions promoted by active drug abuse. She suggested that work on buspirone, the D3 receptor antagonist and partial serotonin 5HT agonist used to treat generalized anxiety disorder, has shown that it may reduce cocaine self-administration in rhesus monkeys. This would be of considerable clinical interest, since addiction medicine presently has no effective drug treatments to offer for stimulants like cocaine and methamphetamine. A large clinical study now underway is showing that buspirone blocked D3 receptors in monkey brains in a way that reduced their interest in cocaine.

And she referred to the failed promise of NicVax, the short-lived vaccine for cigarette addiction. The treatment “failed to meet the primary endpoint in Phase II trials.” In other words, it flunked out. Only 30% of addicted smokers developed sufficient antibodies from NicVax to do them any good. But she cited new research on an alternative approach to vaccines, including a new cocaine vaccine (dAd5GNE) shown to be effective in reducing cocaine addiction-related behaviors in rats through the long-term blockade of dopamine transporters.

In a related approach to producing a reliable anti-cocaine antibody, researchers in the Department of Genetic Medicine at Weill Cornell Medical College went to work on “an adeno-associated virus (AAV) gene transfer vector as the delivery vehicle to persistently express an anti-cocaine monoclonal antibody in vivo, which would sequester cocaine in the blood, preventing access to cognate receptors in the brain.” An AAV is a small virus that is infectious but not pathogenic in humans. You might have it right now, but wouldn’t know it, since AAV doesn’t cause disease. So, the researchers used an AAV to build a transporter mechanism for their monoclonal antibody, GNC92H2. In mice, the result was “persistent serum levels of high-affinity, cocaine-specific antibodies that sequestered intravenously administered cocaine in the blood.”

And finally, while the name is still up in the air, a new national institute combining the study of alcohol and the study of all other addictive drugs will follow after final recommendations submitted to NIH Director by year’s end. Volkow briefly laid out the timeline of the merger for the assembled scientists. Call it the Institute for Substance Use Disorders, or the Institute for Addiction Disorders, or the National Institute of Substance Abuse, but whatever the eventual name, it will be fully operational by late 2013, or at least that’s the plan—and Nora Volkow, the current director of the NIDA, which will merge with, or rather absorb, the National Institute on Alcohol Abuse and Alcoholism (NIAAA), won’t be its director (See "NIH Turf Wars"). Whether that’s good or bad is the subject of much debate, but the project marches on, and seems sensible in the end.

Thursday, October 14, 2010

Who Controls Addiction Research?


The ongoing merger wars at the NIH.

As researchers await the National Institute of Health director’s decision on the matter of merging the nation’s two major addiction research agencies, interested parties to the dispute continued to wonder whether the alcoholic beverage industry will weigh in on the matter—with cash.

The National Institute on Drug Abuse (NIDA) and the National Institute on Alcohol Abuse and Alcoholism (NIAAA) exist within the large institutional framework of the National Institutes of Health (NIH), and operate under mandates that overlap enough to make them prime candidates for a cost-saving consolidation. Advocates of the merger, most of them advocates for NIDA, also suggest that the research itself will improve as a result of a decrease in “overlapping missions.” (See my earlier post.)

Recently, Nature News suggested the possibility of efforts against the merger from another interested party: “Although the alcohol industry is unlikely to relish its legal product being lumped in for study with street drugs such as cocaine and heroin, it has so far remained silent. US Trade groups including the Beer Institute, the Wine Institute, the American Beverage Institute and the Distilled Spirits Council of the United States all declined to comment for this article.”

DrugMonkey, an anonymous NIH-funded researcher, has noted on his blog: “I’m still betting [the beverage industry’s] entire strategy (if they actually care about this, which I suspect they do) is going to be by trying to get a pet Congress Critter or two to oppose the plan. Spirited opposition can probably block the whole plan.”

 DrugMonkey even notes that by one common yardstick—recent success rates for grant applicants—NIAAA has actually put up better numbers than its larger cousin, NIDA, “something that NIAAA people have been quietly bragging about for the past several years.”

There have been other rumblings. Behind the scenes, some NIAAA proponents have criticized NIDA’s Nora Volkow for what they see as a heavy-handed attempt on her part to steamroll any opposition to the merger.  The battle lines were clearly drawn earlier this year when Volkow testified before the Scientific Management Review Board. Quoted in the NIH Record, a National Institutes of Health publication, Volkow said that “all psychiatric disorders have similar roots involving combinations of genes and environment…. it is a serious problem, a devastating problem, whether you are talking about alcohol or drugs.”  The NIDA director also said she was “impatient” with progress on the matter, arguing that the separation of resources had already resulted in missed research opportunities. “Why put roadblocks in the way of treatment and prevention?”

At the same meeting, acting NIAAA director Dr. Kenneth Warren offered up what has come to be seen as the basic counter-argument: “The best way forward is a structure that increases collaboration all across NIH… nothing is gained by structural merger.” Warren said he favored “a separate, but equal” pair of agencies. “Alcoholism is a much broader issue than simply addiction.”

Here is where it starts to get tricky. The assertion that alcoholism is not simply an addiction distills the disagreement down to its essence, which can be found not so much within the arena of science as within the arenas of morality, ethics, and the law. NIH Director Francis Collins told Science (sub. required): “Alcohol is after all a legal substance and 90% of us at some point in our lives are comfortable with taking it in while the drug abuse institute is largely focused on drugs that are not legal.”

As Maia Szalavitz wrote at TIME Healthland:

There's another, somewhat moralistic argument for keeping the institutes separate. As Dr. Deborah Hasin argued at a February national advisory meeting on the question, “[There is] a need for a public health message more nuanced for alcohol than for drugs, including nicotine. In contrast with drugs, light drinking is not “bad.'’ It was a curious statement from a scientist who is supposedly charged with studying the effects of psychoactive substances objectively.

Does the NIAAA really have any solid, science-based arguments against the creation of a combined research agency?

Just ask them. Officially, the NIAAA has a very long list of reasons why they are just saying no to the merger—which looks, from the NIAAA point of view, more like an acquisition, anyway. Here are some of acting director Warren’s arguments, taken from an appendix to the minutes of the February 3-4 meeting of the National Advisory Council to the NIAAA, over which Warren presided:

--Alcohol use disorders are different than drug addiction. "The genetics of alcoholism differs from the genetics of drug addiction. Prospective studies have shown that the sons of alcoholics are at greater risk for alcoholism than for drug dependence.”

--The existence of certain commonalities in the brain pathways that mediate the rewarding effects of alcohol and other drugs of abuse does not justify the merger of NIAAA and NIDA. "The fact that dopamine is an important neurotransmitter in signaling reward associated with motivational stimuli does not provide a strong rationale for merging institutes.”

 --Most people with AUDs (alcohol use disorders) do not abuse other drugs.  “The large size of the population with AUDs who don’t abuse other drugs and the enormous public health burden of their illness justify NIAAA’s focused approach to research on AUDs, separate from drug dependence.”

--Alcohol differs from other drugs of abuse in the degree to which heavy use damages the brain and other organs. "Alcohol damages multiple organ systems through common mechanisms of toxicity, including oxidative stress, the disruption of critical cell signaling systems, and the generation of toxic metabolites, cytokines, and chemokines. The coordinated study of these multiple organ toxicities is best suited to a single alcohol Institute.”

--The systems approach is essential to the study of alcohol beneficial and adverse effects. "The merger of NIAAA with NIDA to form a new Institute focused on addiction would orphan and dissociate critical programs focused on alcohol and cardiovascular health, liver disease, pancreatitis, fetal alcohol spectrum disorders, immune disorders, myopathy, neuropathy, and brain disorders.”

Almost all of these contentions are open to debate. I believe some of them are just plain wrong. Nonetheless, the notion that a merger of two or more sprawling federal agencies will automatically streamline and strengthen government operations is equally open to question (See Department of Homeland Security). 

But the greater weight of logic, it seems, continues to tip the argument in the direction of a merger. Legal or illegal should have very little to do with it. David Rosenbloom, director of Join Together, said in an excellent article by Bob Curley that a single NIH addiction institute could “yield important science and public health benefits.”

Rosenbloom added that “many individuals with addiction use alcohol and tobacco and drugs at the same time. A broad addiction institute may be better able to design and sponsor clinical, basic, and health services research that matches this real-world reality instead of focusing on just one substance at a time.”

Wednesday, September 22, 2010

NIH Turf Wars


Combining Addiction Agencies.

For nearly a decade, the idea of combining the federal government’s two primary addiction research institutes has made good sense. Recently, an independent panel officially recommended a merger—but alcohol researchers opposed the notion, as they have in the past.

The National Institutes of Health, the nation’s premier biological research institution, is composed of 27 separate medical institutes, each fighting for its share of funding and recognition under the larger umbrella of the parent organization. If this seems like an unwieldy arrangement, that’s because it is. Duplication and overlap is inevitable in as vast an enterprise as the NIH. Yet the arrangement has produced some of the best medical and biological research in the world.

Former NIH director Harold Varmus complained, according to ScienceInsider (Sub req) “that the sprawl hobbles NIH’s ability to respond to new science.” The most obvious case for streamlining and cost-savings has always been the National Institute on Drug Abuse (NIDA) on the one hand, and the clumsily named National Institute on Alcohol Abuse and Alcoholism (NIAAA) on the other.

In 2006, Congress told the NIH to create the Scientific Management Review Board to recommend ways of overhauling the NIH structure. The obvious place to start was with the two overlapping addiction institutes.

It was not a new idea. In 2003, the National Academy of Sciences (NAS) recommended merging the agencies due to “overlapping missions.” Enoch Gordis, then director of the NIAAA, was adamantly opposed to the idea, and the undertaking fell away.

Recently, the Scientific Management Review Board of the NIH voted 12-3 in favor of the merger, and sent the proposal to the desk of NIH director Francis Collins. However, the board also recommended an outside search for a director, thereby eliminating current NIDA director Norah Volkow from consideration. Dr. Volkow has been an active and public advocate for addiction awareness. An obvious choice to head the combined institute, provisionally known as the National Institute on Addiction, she would be a significant loss to the NIH. A spokesperson for Dr. Volkow would only offer NIDA’s official stance on the matter: “NIDA’s position has always been that we should create an organizational structure that best serves the science of addiction. We appreciate the thoughtful process that preceded the Board’s recommendation, and we look forward to hearing about a final decision soon.”

For years, NIAAA supporters had a ready answer when asked what made their agency different from NIDA: the liver. NIAAA did research on the liver and other organs and metabolic processes involved in metabolizing alcohol. But over the past two decades, the meaningful research coming out of NIDA has been the primary focus for most addiction researchers. NIDA’s forceful and forward-thinking director, Norah Volkow, followed an equally outspoken director, Alan Leshner. At NIAAA, the most recent director, Dr. T.K. Li, came to the institute after a distinguished career as an alcohol researcher at the University of Indiana. Dr. Li recently retired and the position is being filled on an interim basis by acting director Kenneth Warren.

NIAAA has always been the weaker sister in the addiction research family. With only half of NIDA’s billion-dollar budget, NIAAA deals strictly with alcohol research, even if the NIAAA has at times seemed unsure of what constitutes its main area of study—alcohol the addictive drug, or alcohol the healthy beverage. The merger would represent a recognition that alcohol is just another drug, albeit a legal one.

However, in a Science (sub req) interview, Francis Collins, the current director of the NIH, noted that the advisory board was “not able to come to a consensus” on the NIDA-NIAAA merger. “I guess most people would have said, ‘Well yeah, of course.’ But when you look at the details…. and you consider that alcohol is after all a legal substance and 90% of us at some point in our lives are comfortable with taking it in while the drug abuse institute is largely focused on drugs that are not legal. So there's a personality of the institute issue here that people thought might be important to preserve, others thought would be good not to preserve.”

The director’s remarks reflect the turf protection responses that this seemingly straightforward move invokes. An article by Bob Curley at Join Together notes that last year, the advisory board “voted unanimously in favor of studying the merger despite the fact that every group and individual testifying live at the hearing opposed combining the two agencies.”

Every group and individual? Curley quotes Lawrence Tabak, former acting deputy director of NIH, who minimized the likelihood of significant cost savings, and said, “there are also some issues that NIAAA deals with that are not ‘addictive’ in nature, such as binge drinking.” Representatives from the Research Society on Alcoholism and the American Association for the Study of Liver Diseases said that NIAAA’s harm reduction approach to alcohol use was “fundamentally at odds with NIDA’s focus on illegal drugs.” The National Association of Addiction Treatment Providers also opposed the merger, citing fears of a “loss of focus” on the problems unique to alcohol.

Beyond the official testimony, many prominent drug addiction experts feel differently. “The basic biology of drug abuse and addiction are highly overlapping for all drugs of abuse,” according to Eric Nestler of the department of neuroscience at the Mount Sinai School of Medicine. “There’s a huge confusion—not only among the lay public but among some treatment providers too—that alcohol is ‘not a drug,’” he said in the Join Together article. “This is absurd, yet the current separation of alcohol into a separate institute provides credence to that notion.”

According to noted addiction researcher Charles O’Brien of the University of Pennsylvania’s department of psychiatry, “There’s no scientific rationale to have a separate institute for a single drug. Ethanol activates the reward system similar to opioids and other abused drugs using different mechanisms to act on the same structures.” In addition, O’Brien notes that most addicts use more than one drug, but that NIAAA funding limit researchers to projects for “pure alcoholics, despite the reality of the clinical populations.”

The dual agencies, by their very existence, imply that addiction to alcohol and addiction to other drugs are wholly separate spheres of inquiry and investigation—a notion damaging to scientific research and public health. The primary hurdle to the merger is political, not scientific.

On the face of it, the merger makes sense, and in fact is long overdue. To keep these agencies separate means continuing to perpetuate the myth that there is something crucial that separates alcoholism from drug addiction. And there isn’t. Treating alcoholism and alcohol abuse as a syndrome somehow apart from drug abuse and addiction is outdated and unwarranted. We know too much now about both conditions to maintain the pretense.

As DrugMonkey, a pseudonymous science blogger funded by the NIH, summed it up: “If Institutes are to be merged than NIDA/NIAAA is at the very top of the list. If these cannot be merged then I do not see how any other mergers can be accomplished.”

Graphics Credit: http://www.hbcprotocols.com/nihfunds.html
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