Friday, June 28, 2013

CPDD Annual Meeting Public Policy Forum: Part II: Considerations for Regulating Marijuana to Achieve Public Objectives

The second part of the Public Policy Forum focused on marijuana regulation, now that it has been legalized in Colorado and Washington State and now that there are moves toward legalizing it in other jurisdictions, including at the federal level.

Drs. Beau Kilmer and Rosalie Pacula, Co-Directors of the Rand Drug Policy Research Center (Rand Corporation, Santa Monica, CA), outlined a number of considerations relevant to regulating marijuana sales that could help achieve public health objectives.  They also described the current regulatory climate in Colorado and Washington State.

Dr. Kilmer began his presentation by describing design considerations for regulating marijuana sales, including Production, Profit motive, Promotion, Prevention, Potency, Price, and Permanency, or as he referred to these issues, the "7 P's".  He indicated that Colorado and Washington State have focused primarily on taxation policy but have yet to study other relevant issues and how regulations could be instituted to promote public health objectives.

He noted that with legalization, marijuana Production (including delivery and sales) risks will be substantially reduced, and thus it is anticipated that the free market price of marijuana will decline.  This could both increase the numbers of users and increase heavy marijuana use.  If price controls are not instituted and Profits are allowed to be maximized, this also could stimulate marijuana sales and use.  In terms of Promotion, if for-profit companies are allowed to enter the market, countering their marketing activities could be difficult based on free speech issues, and increased marketing likely would result in increased use.  And, currently, there are no plans articulated for Prevention efforts, which again could contribute to increased initiation and chronic use.

Since the tetrahydrocannabinol (THC) content in street Mexican marijuana currently is on the order of 4-8%, much lower than THC levels in marijuana available in dispenseries (10-25%), if THC Potency is not regulated, users may be exposed to THC levels much higher than to which they are accustomed, which could result in unanticipated side effects or other health consequences.  Pricing considerations can have important effects on initiation, as studies suggest that each 10% decline in price results in a 3% increase in initiation.  The degree of Permanency of regulations also may be critical, as if initial policies are flawed and result in suboptimal public health outcomes, a failure to include escape or sunset clauses might make it very difficult to revise regulations down the road.  Dr. Kilmer asserted that all of the 7 P's should be included in any serious discussion of marijuana regulatory policy.

Dr. Pacula followed by again stating that many of these issues are not being discussed or considered by policymakers.  She indicated that if there is a desire to protect those who could be harmed by having increased access to marijuana, that it is important to have a good policy discussion.

She pointed out that we already have good models for alcohol and tobacco regulation that enable their legal use by adults while reducing harm, and these standard practices could be modified and applied to regulate marijuana.  The Rand Corporation convened a meeting in February 2013 both to identify helpful alcohol and tobacco control regulations and to develop consensus public health and other goals for marijuana regulation.

The consensus public health goals for marijuana that emerged from the meeting were to:
- prevent youth access and use
- prevent intoxicated driving
- regulate potency
- minimize use along with alcohol

Regulatory methods that could help attain those goals include setting prices high (to discourage consumption) but not so high as to foster a black market, as well as having either a governmental monopoly option that oversees sales and marketing activities or a strong licensing system that could regulate the types and densities of sales outlets to limit availability (reducing access) and limit competition (to preserve higher prices).

She also noted that as more jurisdictions legalize marijuana, that other public health issues may emerge including clean air concerns (tobacco smoking laws may not apply) and drugged driving concerns (as there is no rapid field test capable of measuring breath or blood THC levels and even if there were, there is no consensus on the threshold level for THC intoxication).

Dr. Pacula finished her presentation by reiterating that marijuana policy aims need to focus on a broader array of questions than taxation and must include public health objectives, and that now is the time to begin discussing these issues.

CPDDBLOG welcomes CPDD member's thoughts on these issues.

Coverage of Part I of the Public Policy Forum can be found here.

Thursday, June 27, 2013

CPDD Annual Meeting Public Policy Forum: Part I: Congress, the NIH Budget, and Friends of NIDA

The CPDD Annual Meeting Public Policy Forum was held on Wednesday June 19th and Co-Chaired by Drs. Martin Iguchi and William Dewey.  Dr. Iguchi opened the session by noting that this was the 10th anniversary of the Forum being held at the CPDD Annual Meeting.  He introduced Dr. Edward Long from van Scoyoc Associates, CPDD's lobbying firm in Washington, DC, who reported on Congress and the NIH Budget.

Ed began his presentation by discussing our current NIH budget crunch, including failed negotiations on budget cuts by the bipartisan Supercommittee, which triggered the Sequester that began in March 2013.  He noted that discretionary spending, which covers funding for NIH, is at its lowest levels since the Carter Administration, resulting in an effective "undoubling" of the NIH budget after accounting for inflation.  Ed said that it is not clear whether the Sequester will continue in future years.

The Sequester resulted in an operating plan that had to accommodate a 5.7% cut versus the prior year budget, which most severely affected NIDA competing grants, the numbers of which were reduced this past year by 7.7% versus the prior year.

The NIDA budget could be cut further in FY 2014 if the House budget, which calls for discretionary spending budgets to absorb the entire Sequester budget reduction (leaving non-discretionary budgets intact), is approved.  This could result in another 26% reduction in the NIH and NIDA budgets.  While this worst-case scenario seems unlikely to occur, Ed suggested that the FY 2014 budget likely will be close to the current post-Sequester budget, which he characterized as a "limp-along" budget.

Ed noted that now is the time to contact your representatives and tell them about the impact of budget issues.  He observed that Congress can act very quickly (even within a single day) and in a bipartisan manner when motivated.  The most recent example of this is the passage of a House bill that prevented Air Traffic Controller furloughs resulting from Sequester cuts, which, had they occurred, threatened to cause serious slowdowns at some major airports and shutdowns of other airports.

The next presentation was made by Forum Co-Chair Dr. William Dewey, who spoke about Friends of NIDA (FON).  He said that FON, which represents over 2 million scientists including CPDD members, supports concentrated lobbying efforts on behalf of addiction researchers, and has been doing so for the last 20 years.

Bill noted that FON has presented 18 Congressional briefings over the last 10 years, the most recent of which was in early March, focusing on addiction concerns for veterans and their families.  FON worked to get the Department of Defense (DoD) involved in supporting addiction research, and there now is a DoD appropriation to fund addiction-related medical research projects within the US Army Peer Review Medical Research Program.

FON also supports the Intel Science Fair by providing funds for awards involving addiction-related research projects, in hopes of stimulating the development of young science enthusiasts who one day may become addiction researchers.

Bill indicated that the role of FON is key because it can lobby Congress directly in support of addiction research, something that NIDA can't do because it is a federal agency.

Bill urged everyone to become involved in lobbying efforts on behalf of NIDA and addiction research.  For those interested in meeting with their Representatives, Friends of NIDA working together with Ed Long and van Scoyoc Associates can help to arrange Capitol Hill meetings in Washington DC and, if you aren't traveling to Washington, also can help set up meetings in your home district, which are equally important.

CPDD via its Education, Outreach and Public Policy and Media Relations Committees intends to provide training to members interested in speaking with Representatives, the Media, and the Public, so we can get the message out regarding the importance and effectiveness of addiction research and treatment, as well as on the economic savings improved treatments confer.

Coverage of Part II of the Public Policy Forum (Marijuana Legalization) can be found here.

CPDDBLOG welcomes CPDD member's thoughts on this issue.

Wednesday, June 19, 2013

NIDA Director Nora Volkow Presents Plenary Session Report from NIDA and the CPDD President's Lecture at the CPDD 75th Annual Meeting

San Diego, CA — National Institute on Drug Abuse (NIDA) Director Dr. Nora Volkow spoke at the Plenary Session at the CPDD 75th Annual Meeting on Sunday morning, June 16, 2013 on “Progress, Priorities, and Opportunities at NIDA.”

NIDA Staff Changes

She began by noting staff changes at NIDA, including the passing of Dr. Toni Shippenberg-Stein, Chief, Integrative Neuroscience Branch. Dr. Volkow remarked that Toni was a friend and colleague, that her passing is a terrible loss for NIDA and the whole field, and that we all will miss her very much.

She also reported that Dr. David Shurtleff, former Acting Deputy Director, has left NIDA to become the Deputy Director for the National Center for Complementary and Alternative Medicine (NCCAM). This too is a loss for NIDA as Dr. Shurtleff did incredible work for NIDA, according to Dr. Volkow, and she wishes him well in his new position. A search is on for a permanent NIDA Deputy Director.

Other changes include the development of a new translational research office within NIDA, which will be led by Dr. Elena Koustova, the retirement of Dr. Terry Levitin, Director of the Office of Extramural Affairs (a search is underway for her replacement), and the appointment of Dr. Jack Stein to become Director of the Office of Science Policy and Communications.

NIDA Budget Concerns

Dr. Volkow next turned to budget issues, noting that the Sequester has resulted in a 5.5% cut of the overall NIH budget, that the budget is in continuing resolution mode, and that the Sequester duration is unknown. She characterized the cut as being “extremely unfortunate”, forcing reductions in noncompeting renewal grant budgets and in numbers of new grant awards.

She next described the NIDA research budget allocation, with 44% going to basic science research, 24% to epidemiology, 13% to pharmacotherapies/medical consequences, 8% to intramural, 6% to Research Management and Support, and 5% to the Clinical Trials Network (CTN). She noted that some concerns have been expressed within the research community that the NIDA investment in clinical trials is draining resources from other research areas, but the distribution, which has been stable for some time now, shows that the CTN allocation as a percent of the total budget is not substantial.

Recent Substance Abuse Trends and Research

Next, Dr. Volkow focused on trends in substance abuse, noting that the 2012 Monitoring the Future (MTF) survey of high school students reported that synthetic marijuana abuse is on the increase, climbing to the 4th most widely abused substance, with over 11% of high school students reporting use of these substances. 

She also noted that hospital treatment admissions as a consequence of prescription opioid use have increased 5-fold in last decade, that overdose deaths have tripled over last 2 decades (amounting to about 100/day in the United States), and that in some states, there are more deaths resulting from opioid overdoses than from automobile accidents. These increased rates of hospitalizations and deaths likely result from increased availability of opioid pain medications, as over 200 million prescriptions were filled last year alone.

In response to this epidemic, NIDA will begin soliciting medications development grant applications aiming to lower abuse potential, reduce the likelihood of diversion, and decrease diversion and tolerance development, via the SBIR and STTR programs.

Dr. Volkow next discussed recent trends in tobacco and marijuana use, which are in part encouraging (the MTF study reported that tobacco use is down in high school students) and discouraging (marijuana use is up: 22.5% report past month use, 45% of 12th graders report lifetime use, and 6% report regular use). She pointed out that the marijuana statistic is alarming given recent findings on the effects of long-term marijuana abuse on cognition. The prospective study followed over 1,000 people from birth to age 38, during which cognition and marijuana dependence were repeatedly assessed.

Subjects initiating marijuana abuse in adolescence exhibited significantly reduced performance on cognitive tasks and reduced Intelligence Quotient (IQ). Further, the study reported what appear to be significant real-world consequences of chronic marijuana dependence: subjects with more frequent diagnoses of marijuana dependence between the ages 18-38 were more likely to have worse attention and memory problems, as reported by third-party informants selected by each subject (Figure). Another alarming finding of the study was that among chronic marijuana users beginning their use in adolescence, cognition did not improve even after subjects reduced their marijuana use, suggesting that some cognitive effects may be irreversible.

To begin to address these potential problems, in March, NIDA issued an Administrative Supplement to inform social, behavioral, and public health impacts of recent US marijuana legalization laws/policies.

Other initiatives mentioned by Dr. Volkow include NIDA’s support of clinical trials to develop new addiction treatments, an important effort since big Pharma tends to avoid this therapeutic area because of perceived small market sizes, complexities of conducting clinical trials in substance abusing populations, high regulatory hurdles, and the stigma associated with these disorders and their treatments. NIDA-supported trials currently under way to develop new treatments for cocaine dependence include a double-blind placebo-controlled Phase II investigation of a bioengineered cocaine esterase (TV-1380) co-sponsored by NIDA and Teva Pharmaceutical Industries, Ltd., as well as trial of a dopamine beta-hydroxylase inhibitor (nepicastat, Syn117), co-sponsored by NIDA and Biotie Therapies. NIDA also sponsors a program announcement intended to support Strategic Alliances for Medications Development to Treat Substance Use Disorders (PAS-12-122), which offers large annual budgets up to $2 million and rapid timelines (3 years).

Next, Dr. Volkow turned her focus to HIV, reporting that we are in a new phase of this epidemic with new infections occurring primarily in minorities and women. Incidence rates now are stable at about 50,000 new cases per year and have not been reduced over time, despite the knowledge that antiretroviral therapy (ART) not only stabilizes those with HIV but reduces HIV transmission rates. She attributed the failure to reduce incidence rates in part to the fact that substance abusers are less likely to be prescribed ART because of stigma and because of the fear that a lack of ART compliance might lead to HIV resistance. She asserted that we must train physicians to get beyond these concerns and make it a priority to seek out and test people who might be affected, treat them with ART, and retain them in treatment to prevent further transmission. Among substance abusers, effective substance abuse treatment improves retention, so physicians must be educated to treat both HIV and any comorbid substance abuse problems. She indicated a need for new treatments to increase compliance among intravenous drug users including longer-lasting medications as well as treatments not based on opioid substitution therapies (which are not permitted in certain countries).

Dr. Volkow ended her presentation as she has in prior years by discussing her selection for “Brain of the Year”, a study using neuroimaging biomarkers to identify brain structures and circuits that predict physical pain. She said the study is highly significant because biomarkers are needed to objectively assist in the development of novel pain medications.

CPDD President’s Lecture

On Sunday afternoon, Dr. Volkow returned to the podium as part of the CPDD President’s Lecture and discussed plans for Functional Integration of addiction research programs within NIH as well as the new Brain Initiative announced by President Obama and NIH Director Dr. Francis Collins.

Functional Merger

Dr. Volkow noted that although the Scientific Management Review Board (SMRB) recommended a structural integration of NIDA, the National Institute of Alcohol Abuse and Alcoholism (NIAAA), and parts of other Institutes sponsoring addiction-related research, the Department of Health and Human Services (HHS) recommended against making a structural change. This recommendation was made because HHS ruled that in this time of budgetary constraints, efforts should be invested in managing budgets and developing functional solutions rather than in developing a new administrative structure needed to support a structural merger.

She reported that the functional integration will be established with input from stakeholders within NIH, that NIDA, NIAAA, and National Cancer Institute (NCI) Directors will lead the effort, and that Councils for respective Institutes will be involved as well. The funding for functional integration will be supported primarily by NIDA (70%), with NIAAA and NCI contributing roughly 20 and 5%, respectively.

Dr. Volkow noted that the next steps in the process include holding a regular series of planning and monitoring meetings, identifying areas of intramural research program integration, and developing a schedule for joint Institute Council meetings, the first of which may take place in February 2014. She reported that part of the initiative includes finding and appointing a permanent NIAAA Director, which will help accelerate functional integration; she expects that an appointment will happen fairly soon. There also are plans to develop a website and to issue Funding Opportunity Announcements for FY 2014.

The Brain Initiative

Dr. Volkow next discussed the new Brain Initiative announced earlier this year by President Obama. The initiative seeks to develop a dynamic picture of the brain in action, with the hope that it will catalyze integrative research and be transformative. The President characterized the Brain Initiative as the “Next great American project”.

The initiative is being sponsored by the Defense Advanced Research Projects Agency, NIH, the National Science Foundation, the Allen Institute for Brain Science, the Howard Hughes Medical Institute, the Kavli Foundation, and the Salk Institute for Biological Studies.

While NIH will contribute $40 million to the initiative, Dr. Volkow noted that this is less than 1% of the overall NIH budget for neuroscience research, and the investment likely will result in wide-ranging research benefits.

Dr. Volkow outlined why this project is necessary:

- 100 million Americans are affected by brain disorders, which are the #1 source of disability

- Rates of brain diseases are increasing in part because we are living longer and because of situational factors (e.g., increased incidences of head traumas and stress disorders)

- Costs to treat brain disorders are escalating (dementia treatment alone costs $200 billion/year, which equals the annual treatment costs for cancer plus heart disease)

- Science is ready, as progress in new technologies (optics, genetics, nanotechnology, informatics, etc.) can catalyze rapid progress

She presented several examples of scientific innovations that will help advance this initiative by improving our ability to understand complex brain processes, including the Brainbow, the Connectome, CLARITY, research in Zebra Fish Larvae, optical imaging technologies, and brain functional connectivity imaging at high magnetic fields.

She also noted that the public will be given the opportunity to review and comment on progress and future directors for the Brain Initiative here.

CPDDBLOG welcomes CPDD member’s thoughts on this issue.

Thursday, June 13, 2013

An interview with 2013 CPDD/NIDA Media Award Winner Mr. David Sheff

Mr. David Sheff is a best-selling author and winner of the 2013 CPDD/NIDA Media Award. He is receiving this award for his contributions that enhance the public understanding of scientific issues concerning drug use disorders, including his books entitled "Beautiful Boy" and "Clean: Overcoming Addiction and Ending America's Greatest Tragedy".

CPDDBLOG interviewed Mr. Sheff to find out more about his background and his work.

CPDDBLOG:  Tell us a little about your background before you wrote your first book on addictions, the bestseller "Beautiful Boy".

David Sheff:  After college I became a journalist, first as editor of magazines (New West, California, Men's Life, Yahoo), and then as freelance writer. I wrote for the Times, Wired, Playboy, Rolling Stone, and many other magazines and newspapers. My articles were about politics, art, movies, the environment, architects, and business. I interviewed a long list of people that included John Lennon -- it was the last major interview before he was murdered, Steve Jobs, Frank Zappa, Congressman Barney Frank, Jeff Bezos, Jack Nicholson, David Hockney, Frank Gehry, Scott Peck, Snoop Dogg, Keith Haring, and many others. I wrote a few books-- Game Over, about Nintendo and the video-game revolution; China Dawn, about the building and impact of the Internet in China, and All We Are Saying, the full text of my interview with John and Yoko.

My first child was born in 1982, my beautiful boy Nic. When he was 12, he tried drugs for the first time. We were reassured-- "kids experiment," "it's a rite of passage," "everyone is doing it-- don't worry, Nic's a great kid and he'll be fine." But he wasn't. He became addicted to meth, heroin, and other drugs. My life changed: I became consumed with trying to save his life.

CPDDBLOG:  What compelled you to write your new book, "Clean"?

David Sheff:  When Beautiful Boy came out, a door opened to the suffering caused by addiction. From our family's experience, I knew how traumatic it is to have a loved one suffering the disease. But I didn't know how pervasive and destructive -- to individuals, families, and society -- until after the book came out. I received hundreds of letters and thousands of emails and comments on message boards. I met countless people as I traveled around the country. The message was the same: Your family's story is our story. The suffering was immeasurable. And too often the stories had different endings: "My beautiful boy died." "My lovely daughter didn't make it."

These families had done what they could to save their children. In most cases, they did much of what I did, try rehabs, residential and outpatient programs, sober living houses, and therapists of every stripe. Nothing worked. I wanted to know why. Why are we so inept when it comes from preventing addiction and, when it hits, treating it. Moreover, I wanted to learn what we could do better.

CPDDBLOG:  What role do you see researchers playing in improving how our society deals with addiction disorders?

David Sheff:   Frankly I see researchers are our hope. I spend a good portion of Clean proving that addiction is a disease. Given that it's an illness-- a serious, progressive, probably chronic, and possibly fatal illness -- it needs to be treated by science-based approaches, just as we treat other diseases. Unfortunately, our treatment system is based on pseudoscience, best guesses, wishful thinking, blame and castigation, and in some cases what borders on voodoo. Researchers have made breakthroughs in treatment. Our current goal is to get those treatments to those people who need them. But we need new and better treatments. These will come from researchers devoted to ending this disease.

CPDDBLOG:  What are your future plans for writing, and do they include additional works on the topic of addictions?

David Sheff:   I plan to continue writing about addiction and related mental illnesses. This is a subject that's not only endlessly fascinating, but of paramount importance. I have a list of articles in mind -- about Narcan; the international drug problem and treatment paradigms throughout the world; the potential of corporations to effect their bottom lines by offering assessment, screening, and treatment for employees who need it; new treatments (vaccines and experimental treatments, for example), and other articles about drug use, addiction, prevention, and treatment in America and beyond.

CPDDBLOG:  What does winning the CPDD/NIDA Media Award mean to you?

David Sheff:  It's fraught whenever a journalist, at least one who isn't a scientist or doctor, ventures into the realm of science and medicine. I'm a layman--a father who had no intention of learning about addiction until I had no choice. As a father and journalist, I sought to understand as much as I could about this disease-- what it is, how it manifests, how it can be treated, and how it can be prevented. As I went forward, I relied on the expertise of many of the nation's preeminent addiction researchers and clinicians. They were patient with me as they explained the complex field of addiction medicine. From the outset I've been aware that my knowledge about this disease pales compared to those who have devoted their lives to understanding and conquering it. For those reasons, an award from CPDD/NIDA -- that is, from the very people on the front lines of addiction research and treatment -- means more than I can say, because they're my heroes. It's not a word I use lightly. Not only did they instruct me, and not only are they treating addicts and improving our ability to prevent and treat addiction, but they saved my son's life.

CPDDBLOG:  Many thanks for taking the time to answer these questions, and congratulations on winning our Award.

David Sheff:   Thanks so much for asking. Its a great honor to receive this award.

CPDDBLOG welcomes CPDD member’s thoughts on this issue.

Wednesday, June 12, 2013

College on Problems of Drug Dependence 75th Annual Meeting

College on Problems of Drug Dependence
75th Annual Meeting
The Hilton Bayfront Hotel, San Diego, CA
June 15-20, 2013

More than 1100 scientists will participate in the 75th Annual Meeting of the College on Problems of Drug Dependence (CPDD) to discuss their latest findings on drug abuse and dependence. CPDD is the largest and oldest organization supporting research on the scientific explanation of drug use and dependence. A broad range of research will be presented addressing mechanisms for development of drug dependence, its prevention, and its treatment, at the Hilton Bayfront Hotel, San Diego, CA.

Among the many research topic presentations are symposia and workshops on the impact of medical marijuana on public health (Symposium II, Sunday PM, Indigo E), the consequences of childhood maltreatment on the development of substance abuse disorders (Symposium VII, Monday PM, Indigo A), health and social effects of substance use in older drug users (Symposium X, Tuesday AM, Indigo E), and the effects of reformulation of opioid pain medications on patterns of abuse and diversion (Workshop XI, Tuesday PM, Indigo 204).

On Sunday morning at the June 16th Plenary Session (Indigo BCFG), achievement awards will be presented to outstanding individuals for their contributions to the field of addiction science. Those honored include Dr. Linda Dykstra, who will receive the Nathan B. Eddy Award for lifetime contributions to the field, Dr. William Stoops, who will be presented with the Joseph Cochin Young Investigator Award, Dr. James Sorensen, who will be recognized for her efforts in mentoring junior drug abuse researchers, Dr. Redonna Chandler, who will be presented with the J. Michael Morrison Award for her outstanding contributions in the area of scientific administration related to drugs of abuse, and Mr. David Sheff, bestselling author, who will receive the CPDD/National Institute on Drug Abuse (NIDA) Media Award for outstanding contributions to the public understanding of scientific issues concerning drug use disorders. In addition, NIDA Director Dr. Nora Volkow will present a Report From NIDA. Later that day, Dr. Volkow also will present a lecture as part of the CPDD President’s Symposium entitled “Functional Integration: Questions and Answers” (Sunday PM, Indigo BCFG).

Other CPDD award ceremonies occur on Monday afternoon (Indigo H) when Dr. Kathryn Cunningham will be presented with the Marian W. Fischman Memorial Lectureship Award and present an address entitled “Serotonin at the nexus of impulsivity and cue reactivity in cocaine addiction.”

Sunday through Thursday, CPDD members will present new and exciting research findings in poster and oral presentations.  Highlighted presentations include reports on how youth participation in team sports is associated with reduced marijuana initiation (Lisha et al., Monday AM, Sapphire), how higher high school math and science education graduation requirements reduce cigarette smoking initiation (Plunk et al., Tuesday AM, Sapphire), on the missed alcohol abuse intervention opportunity post-deployment in former active duty and reserve soldiers (Larson et al., Wednesday PM, Indigo D), and on the use of “Bath Salts”, “Spice”, and other synthetic drugs by injection drug users in San Diego (Wagner et al., Thursday PM, Indigo A). This is only a small sampling of the hundreds of reports and information sessions to be presented.

To learn more about these events and to find topics of interest, search the freely downloadable meeting program and abstract listings by clicking the “2013 Program Book (pdf)” and “2013 Abstract Book (pdf)” links, or by clicking on

Media personnel are invited to attend Plenary and Scientific sessions.