Ebola, The “Right To Try,” And Why We Should Care
Lindsay Boyd was recently published on Forbes discussing Ebola and the “Right-To-Try”. The full article can be found here.
As concerns over the devastating Ebola outbreak in Western Africa have spread across the world this week, one story continues to be underplayed amidst the outpouring of alarming reports. There was a non-FDA-approved anecdote flown into Liberia that is being credited with the recoveries of the two infected U.S. missionaries—but that, under current standards, may not be an option for citizens living in most states, should the outbreak happen here.
Dr. Kent Brantley and Nancy Writebol were serving with Samaritan’s Purse in Liberia when they contracted the Ebola virus from a fellow hospital aid worker. The National Institutes for Health reached out to Samaritan’s Purse with the offer to treat Brantley and Whitebol with ZMAPP, a drug developed by MAPP Biopharmaceutical that has yet to be tested by the Food and Drug Administration (FDA). Before Brantley and Whitebol’s treatment, MAPP’s serum had only been tested in small experiments on monkeys with promising results.
The FDA maintains an arduous approval process for new drugs before they are made available to the masses. In fact, according to the California Biomedical Research Association (CBRA), it takes an average of 12 years “for a drug to travel from the research lab to the patient.” Just 10 percent of developed drugs ever make it to the human testing stage and only one in five of these are ultimately made available to the public. CBRA also estimates the average cost for bringing a new drug from the lab to a patient is $359 million. Understandably, many beneficial treatments fail to make it to market simply because of the associated price tag. While a FDA “compassionate use” provision does exist for the administration of experimental treatment in more extreme circumstances, approval for such access is long and bureaucratic. Thus, it is difficult to nearly impossible for legitimate claims to circulate through the necessary channels in time to actually benefit a critical patient.
Fortunately for Brantley and Whitebol, the high-profile focus on the spread of Ebola created opportunities for them to circumvent the mandated process quickly. However, thousands of Americans enduring terminal illnesses do not have the same opportunities. Imagine if your parent, child, or sibling was diagnosed with a terminal disease—yet there was a drug in Phase II or III of the FDA approval process with demonstrated, positive results in experimental trials for treating your loved one’s condition. With no options left for a cure within the current medical environment, would you not want the right to try this drug with the hope that it may prove effective?
This is the logic behind the “Right-to-Try” bill—a new piece of legislation signed into law in Colorado in May, and making its way through state legislatures in Arizona, Missouri, and Louisiana—giving terminally ill patients in these states the right to try experimental medication. As Brantley and Whitebol’s cases illustrate, there are circumstances in which the FDA mandates can legally prevent the most vulnerable and afflicted from receiving potentially life-saving treatments. Arthur Caplan, of New York University Langone Medical Center, asserts that the FDA process can take years—and many terminally ill patients do not have years to wait. Right-to-Try laws could allow such patients to circumvent the FDA mandates.
The Goldwater Institute in Arizona was instrumental in crafting this legislation and has documented several cases in which terminally ill patients have received life-changing treatments through experimental drugs. Lorraine Heidke-McCartin was diagnosed with Stage IV breast cancer in 2006, and after tireless efforts over a three-year period, had exhausted all of her medical options. In 2009, she was able to make regular visits to a trial center in Virginia from her home in Boston to participate in clinical testing for a potentially life-saving drug. Lorraine has been cancer-free since 2011.
“Right-to-Try” legislation gives those like Lorraine with no remaining options the ability to hope again. These laws remove the bureaucratic obstacles to treatments like ZMAPP for thousands more. So as the heightened concerns and alarm over the potential spread of Ebola make headlines, let us extend the same life-saving opportunities afforded Brantley and Whitebol to terminally ill Americans all across our nation.
Lindsay M. Boyd is Director of Policy at the Beacon Center of Tennessee. Her articles have been published in Forbes, Daily Caller, Washington Times, and Townhall.com, amongst others.