By Rachel Burger
Ebola is continuing to terrorize West Africa. Over a thousand people have died from the outbreak, and with over 1,800 reported cases, it looks like the outbreak will continue to spread.
The World Health Organization released a statement on Tuesday that claims it’s ethical to provide Ebola patients with untested drugs provided patients give their consent.
ZMAPP, from Mapp Biopharmaceutical, has been touted as a miracle drug that could hamper the Ebola outbreak. According to NPR’s Ofeibea Quist-Arcton, “ZMAPP was the drug given to an American doctor and a health worker infected with Ebola in Liberia and flown back for care back home. Nigeria, which has reported two Ebola deaths, says it has requested the drugs from the Centers for Disease Control.” After the WHO’s statement, Mapp Biopharmaceutical and the US government agreed to ship ZMAPP to Liberia.
In a brief online statement released Tuesday, Mapp Biopharmaceutical now claims that “The available supply of ZMapp™ has been exhausted.” They add that the drug has been supplied “at no cost in all cases.”
The sad reality is: without red tape, this drug would be far more widely available.
Dr. Thomas W. Geisbert, professor of microbiology and immunology at the University of Texas, recently told the Huffington Post, “It’s a very long regulatory process. From the time to develop a vaccine for animals in a lab to protecting humans… it’s really just a lot of regulatory hurdles and red tape.”
And those hurdles are substantial. Drugs take 12 years to go from discovery to FDA approval, and, on average, five to seven of those years are testing rounds just to meet FDA standards. Successful drugs cost about $1.8 billion to the company before consumers have access to it.
It’s no wonder Ebola drugs aren’t available to the public yet. Even though the drug has performed well on monkey trials, the cost to shift to human trials may be insurmountable for many companies. It’s amazing that Mapp Biopharmaceutical would be willing to supply its drugs to Liberia at all–let alone for free. But given the fact that the WHO and US government waived the need for human trials given provided adults gave their consent, shouldn’t this practice extend to other deadly diseases? Shouldn’t the FDA allow consumers, especially those with deadly diseases, to choose what to put into their own bodies?
A few years ago, The New York Times ran a front page story about a young man who died because he was in the control group of a skin cancer trial. His cousin, who was in the same study and received the tested drug PLX4032, survived because he was able to continue taking the drug after the trial was over. The young man who died had requested access to the drug as well, but was denied because his results could have limited the company’s access to FDA approval because his recovery could have warped the trial statistics.
In cases such as these, is it really ethical to prevent people from taking a drug of their own volition?
The FDA’s approval process costs too much money and wastes too much time. People’s lives are on the line. It slows down the process for companies to make life saving drugs like PLX4032 and ZMAPP, and prevents a quick response to outbreaks like Ebola.
If the World Health Organization is willing to make a special case for the outbreak in West Africa, the FDA should reconsider extending the same courtesy to patients here. Consider allowing special access to leukemia and lymphoma, brain cancer, and heart disease drugs for patients who are not able to participate in trials. It’s within the bounds of reason to ask them to sign a waiver not to sue the company that might save their lives.
This option could be lifesaving for millions of people. It would incentivize drug companies to make more drugs and offer them a revenue source while trying to obtain FDA approval. Exceptions shouldn’t be made for African Ebola patients or doctors; the exception should be made for everyone.
While I understand that the balance between approving drugs quickly and avoiding approving drugs that don’t is an age-old medical and philosophical debate, this isn’t: allow people to put what they want into their own bodies. Yes, it might kill them. Yes, it might have horrible side effects. But when the alternative may very well be death, what would you choose?
Rachel Burger is a Young Voices Advocate and is the associate editor of a popular news and politics blog. She writes frequently about social issues and foreign policy, and has been published in Forbes, TownHall.com, and The Libertarian Republic. Rachel graduated with an MA from University of Chicago’s Committee on International Relations and with a BA from Agnes Scott College.