The recent departure of Dr. Scott Gottlieb from the helm of the Food and Drug Administration (FDA) provides a fresh opportunity to review where we go next on one of our most immediate issues: our national response to the opioid crisis.

There are times when an epidemic sweeps through our American society and takes out an entire generation of its population in short order. The opioid epidemic ravaging U.S. communities is reminiscent of the HIV/AIDS epidemic that struck the United States in the 1980s.

Until 1987 we had not one drug to treat those affected with HIV, but today we have over 30 drugs to treat HIV infection. With the use of combination HIV “cocktails,” treatment is now “one pill once a day” and these medications have shown to be safe, effective and well-tolerated. Persons living with HIV today can expect to have a normal life span.

I was fortunate to have started my clinical research career working on virtually all the early HIV medications and on some of the later HIV combinations that transformed HIV from a devastating disease to a manageable chronic condition, much like hypertension.

How did we approach the HIV crisis?

Solutions came via a three-pronged approach attacking the virus directly with medications, developing surrogate markers to measure the efficacy of these medications, and establishing more sophisticated clinical trial designs— all to get life-saving medications to patients more rapidly. Defining targets and designing sophisticated, non-addicting drugs for pain is not out of the question in our future.

What we learned from the HIV/AIDS experience is when there is no magic bullet on the horizon, no one government agency or company could solve a crisis of such magnitude. The same applies to the opioid epidemic.

In the absence of any viable treatments for what came to be known as HIV/AIDS in the early 1980s, stakeholders from all parts of our country, including the Food and Drug Administration (FDA), National Institutes of Health (NIH), Centers for Disease Control (CDC), the Surgeon General, the Centers for Medicare and Medicaid Services (CMS), along with patient advocates, pharmaceutical and biotechnology companies, came together to fight that epidemic.

We must develop this multi-faceted approach for addressing the opioid crisis. 

Now is the time for a call to action: the combined efforts of all stakeholders must come together to find safe and effective alternative pain medications that obviate the need for opioid products.

It is inconceivable to me that a person can get addicted to an opioid after a dental procedure, yet, apparently, this is not uncommon. There is nothing so unique about pain that we cannot find treatments to alleviate suffering without addiction.

The newly established NIH HEAL Pain Management Effectiveness Research Network is being formed and will replicate in pain what was established for HIV/AIDS, namely the AIDS Clinical Trials Group (ACTG), a network of academic and community-based research sites working collaboratively with government, industry and patient advocates. FDA must work closely with the NIH HEAL Initiative in developing and approving alternative pain medications for Americans.

 

The FDA’s Fast Track Designation that allows expedited review of alternative pain products is a good start, but it is not enough. Exciting new products are in the development pipeline. However, proving efficacy is challenging because no validated measurable biologic test like measuring the HIV RNA in blood exists for pain. Measuring pain objectively in clinical trials remains a challenge.

To paraphrase Lord Kelvin, the Scottish mathematician and physicist who developed the Kelvin scale of temperature measurement: “science begins when you have something to measure.” Developing better ways to measure pain control is possible.

Moreover, like HIV, combination medications that target different points in the neurological pathways causing pain may be required. Novel regulatory pathways must be developed to encourage this approach.

The other lesson we learned through the HIV/AIDS crisis is that the research and development in one area spill over, creating a halo effect for other medical indications. Many of the HIV/AIDS discoveries provided advances and treatments for many other rare parasitic, viral and fungal infections.

In the same way, gathering our forces to find non-addicting alternative pain medications would have tremendous impact on treating the pain associated with cancer and end-of- life illnesses, as well as other devastating neurologic diseases.

Despite the gloominess over our current opioid crisis, I remain optimistic about our future. With review and application of past learnings along with the right commitments, tools and funding, together we can end this American opioid epidemic.

Dr. Anthony Japour worked in the HIV/AIDS indication for over 20 years at the height of the HIV/AIDS epidemic and is presently a medical director at ICON, plc., working in the pain indication as well as cardiovascular, vaccine and other infectious disease indications. The views expressed are those of the author and not those of ICON.