By: Danielle Friend, Ph.D.
Federal Biomedical Research
The White House plans to make conducting marijuana research easier
Obama is making moves that will make it easier for scientists to access marijuana for research purposes. Currently, the National Institute on Drug Abuse partners with University of Mississippi as the sole source authorized to grow marijuana for scientific research. However, many scientists who would like to study the drug state that because only one institution is authorized to produce the marijuana, researchers often must wait years to obtain it. In order to increase the amount of research grade marijuana available, the Drug Enforcement Administration (DEA) will grant more universities the ability to apply for permission to grow marijuana.
Marijuana is currently approved for medical use in 25 states treat conditions such as Parkinson’s, Crohn’s and Alzheimer’s disease, Tourette’s syndrome, lupus, rheumatoid arthritis, and more. However, although it is approved for medicinal use, it remains unclear how effective marijuana is for treating these diseases, an answer that requires clinical research. Furthermore, whether marijuana impacts the developing brain or causes long-term change in brain function are questions that are simply not known. Increased production of research grade marijuana may allow scientists to answer these questions faster.
One additional barrier that stands in the way of scientists conducting marijuana research is the fact that marijuana is considered a schedule I drug, meaning it has no recognized medical benefit. Schedule I drugs have the most restrictions and this category also include drugs such as heroin, LSD, ecstasy, methaqualone, and peyote. In order to conduct marijuana research, researchers must first obtain a Schedule I drug license which is often very difficult and time consuming. However, the DEA suggested earlier this year that they may move marijuana to a less restricted category, thus allowing researchers to more easily to the drug. (Catherine Saint Louis and Matt Apuzzo, New York Times)
Stem Cell Research
The National Institutes of Health reconsiders moratorium on human-animal stem cell research
The National Institutes of Health (NIH) announced this month that it is reconsidering the ban on some human-animal stem cell research. For quite some time now, researchers have been transplanting human cells into animals to study things like cancer and tumor formation. However, the specific transplantation of stem cells, cells that have the ability to become many cell types in the body including skin cells, blood cells, into cells that make up the kidneys, brain, has been banned.
Lifting the ban on human stem cell chimera research would allow scientists to conduct experiments like growing human kidneys in pigs, kidneys that could later be given patients waiting a transplant. This advance could significantly decrease the wait time on organ donor lists.
While advances such as growing organs for patients in need of transplants sounds intriguing, several concern regarding the use of human-animal stem cell research still remain. Dr. Paul Knoepfler, a scientist at the University of California, Davis is concerned about ethical issues that may arise when, for instance, human stem cells are injected into an animal’s brain. “There’s no clear dividing line because we lack an understanding of at what point humanization of an animal brain could lead to more human-like thought or consciousness,” he stated. Despite the changes mentioned above, the NIH will still ban funding for research that would result in an animal with human sperm or eggs that would then be bred.
The change to the human-animal stem cell ban is currently in a 30-day public comment period where members of the public can voice concerns and questions regarding the proposed changes prior to change taking place. More information can be found in a blog post written Dr. Carrie Wolinetz, the Associate Director for Science Policy at the NIH. (Gina Kolata, New York Times)
Phase 1 begins for Zika vaccine
The National Institute of Allergy and Infectious Diseases (NIAID) announced this month that it will begin a safety and efficacy clinical trial for a vaccine against the Zika virus. The director of NIAID, Dr. Anthony S. Fauci, M.D. stated “A safe and effective vaccine to prevent Zika virus infection and the devastating birth defects it causes is a public health imperative….NIAID worked expeditiously to ready a vaccine candidate, and results in animal testing have been very encouraging. We are pleased that we are now able to proceed with this initial study in people.”
The first stage of the clinical trial will include approximately 80 volunteers ages 18-35. During this safety and efficacy portion of the trial, healthy volunteers will be randomly divided into one of four study groups. Each participant will receive a vaccination at their first visit, and half of the participants will receive one additional vaccination eight weeks or 12 weeks later. The remaining participants will receive two additional vaccinations. Each participant will receive the same dose at each vaccination. Participants will then return for follow-up visits after the first vaccination so investigators can monitor their health to determine if the vaccine is safe. Investigators will also take blood samples to test the immune response to the vaccine. Findings from these trials are expected to be completed by January of 2017. Should the findings indicate that the vaccine is both safe and effective, NIAID plans to begin more to phase two clinical trials, a phase where the vaccine is given to a larger group of volunteers to further evaluate the vaccines safety and efficacy. This they believe, will begin in early 2017.
The clinical trial for the new vaccine is part of the U.S government’s response to the outbreak of Zika in the Americas. Increased concern about the virus has spread across the United States as the first cases of locally transmitted Zika in Florida and an infant death in Texas associated with the virus have been documented. Although the first phase of the trial began this month. Dr. Fauci said he is concerned about running out of money to launch the larger phase two next year. President Obama asked Congress to approve $1.9 billion in emergency funding for Zika in February, but lawmakers were not able to agree on a funding package, and have since left for their August recess. Without more money, the future trial phases may be delayed. (NIH news release)
New steps for reducing the Opioid Epidemic
President Obama signed new legislation into law in late July aimed at mitigating the growing opioid epidemic in the United States. The growing concerns regarding opioid abuse have risen from data indicating that deaths associated with prescription opioids have increased by 16% while death associated with heroin have increased by 28% since 2013. Even more strikingly, deaths associated with synthetic opioids like fentanyl and tramadol have increased by 79% between 2013 and 2014 alone. In fact, deaths associated with heroin, prescription drugs, and opioid pain relievers surpassed death associated with car accidents as the leading cause of injury-related deaths. Given these statistics, opioid abuse has been a hot topic across party lines. Early on in the primaries for both democrat and republican nominations, Hillary Clinton discussed the priority of developing legislation to end the epidemic while other candidates including Jeb Bush, John Kasich, Chris Christie, and Carly Fiorina all expressed interest supporting such legislation.
The new billed also known as the Comprehensive Addiction Recovery Act of 2016 or S.524 and H.R 953 had received strong support across party lines. The Senate version of the bill passed 92 to 2 and the House version received co-support from 53 Democrats and 21 Republicans.
The new bill uses several approaches to help reduce opioid use and addiction by:
- Increasing the availability of naloxone, a drug used to prevent deaths associated with opioid overdose. Plans including providing naloxone to law enforcement and other first responders.
- Improving methods for monitoring opioid prescriptions. In fact, the CDC released new guidelines earlier this year for the prescription of opioids. This part of the bill will help states better track where prescriptions are going and who is prescribing them. Better monitoring will also help prevent current opioid users from receiving more drug than is need for pain relief.
- Providing increased resources to treat individuals with addiction rather then implementing punishment or incarceration.
Although President Obama supports the new bill, he suggested it will hopefully be the first step among many to combat the epidemic. “This legislation includes some modest steps to address the opioid epidemic,” the president said in a statement. “Given the scope of this crisis, some action is better than none.” (CJ Arlotta, Forbes)
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