President Donald Trump last month officially declared the opioid epidemic a national public health emergency under federal law. The U.S. Department of Health and Human Services defines a public health emergency as “an emergency need for health care [medical] services to respond to a disaster, significant outbreak of an infectious disease, bioterrorist attack or other significant or catastrophic event.”
As a scientist heading an addiction institute I have seen the quiet storm that has grown into a tidal wave that has engulfed America. The president took an important step in addressing this and should be commended for it. But if he hopes to actually resolve the opioid crisis, he’ll need to use the power of his office to help the scientific and medical communities find viable, non-addictive alternatives to opioids.
Scientists across America, including myself, are dedicated to finding non-addictive medications for managing chronic pain and as alternatives to the current opioid medications such as methadone, which are narcotic substitution strategies used to manage opioid addiction. Such non-addictive alternatives include natural plant products, vaccines, chemical and molecular modification of pharmaceutical compounds, repurposing medications currently used for treating other diseases, and state-of-the-art techniques that alter brain activity. We are increasingly hopeful about these non-addictive alternatives. We now need to move them to clinical trials to make sure they work and to promote discovery of other novel treatments.
Most non-traditional approaches lack a path for rapid testing outside the normal pipeline for therapeutic development. The bottleneck in the research-to-treatment pipeline is unknown to most people outside of science, no doubt including to the president. It currently takes over two years for a normal research grant to be funded and initiated. Applications with non-traditional approaches often never even make it to the funding stage. If the research strategy is truly novel, the project will require Food and Drug Administration (FDA) approval for clinical research, which can take an additional year. Then completing the clinical trial itself could last up to five years.
We can’t spend so much time getting these research projects off the ground. According to the Centers for Disease Control and Prevention, 45,788 people died from opioids over a 12-month period ending in January 2017.
In issuing his declaration, Trump initiated several federal initiatives to help people with opioid addiction, such as methadone treatment programs and more flexibility for hospitals in hiring substance abuse specialists. However, these are the same treatments that have been used forever. They are not preventative measures nor do they provide new therapeutic options to the large number of people still not served by the current programs.
If Trump hopes to actually make a significant impact in the opioid epidemic, he’ll need to invest significant funds in supporting fast and high-level research that moves quickly into the clinic. Declaring the opioid epidemic as a national emergency under the Stafford Act instead would have provided direct access to the Disaster Relief Fund, but the administration chose not to—perhaps because the crisis doesn’t necessarily fit under the definition of a “rapid disaster.”
Nevertheless, it would have been a bold step to provide the National Institutes of Health (NIH) with a separate opioid fund (similar to the HIV/AIDS budget mandated by Congress) and a new system for implementing opioid-specific research that can be fast-tracked in scientific development, translated to clinical trials, and implemented in clinical populations. The public health emergency declaration does not eliminate the bureaucracy that stifles fast-track clinical trials and that holds up compassionate care use of novel treatments supported by the NIH and FDA.
Trump can help solve the opioid crisis by allowing the rapid development of alternatives to opioids based on existing scientific research. He can help us win the war we created so we can stop counting the epidemic’s tragic casualties.
Yasmin Hurd is the director of the Addiction Institute at Mount Sinai Behavioral Health System and a professor of psychiatry and neuroscience at the Icahn School of Medicine at Mount Sinai.