Reflecting unanimous agreement from a panel of experts, the World Health Organization said in a statement today that it is ethical to offer unproven drugs to treat or prevent the spread of the Ebola virus.
The panel, including ethicists, researchers, regulators and patient advocacy experts, met to consider the dilemma brought to the forefront after two American health care workers and one Spanish clergyman, who later died, were treated with experimental drugs in scarce supply. The virus, spreading out of control through West Africa, has already infected more than 1,800 people, killing more than 1,000.
“The WHO did the easy part,” says Alta Charo, professor of law and bioethics at the University of Wisconsin, Madison. The moral quandary posed by a rapidly spreading deadly disease that might be helped by as-yet unproven drugs runs much deeper.
What are the bigger ethical concerns?
The biggest is who gets a drug that is in scarce supply. It’s a classic rationing problem. In a public health crisis, there are certain approaches. One is if we have only very small amounts of a drug, we might give it to people who can save other people, like health care workers and other first responders. You need to keep them alive.
After that, there are a number of choices. You can give it first to the people most likely to benefit. Those people may not be evenly distributed in the population. They may be clustered in cities, and they may not be the sickest people. To give it to the sickest people might seem the most compassionate choice — but they may be the people most unlikely to benefit, and die anyway.
Or you can focus on one geographic area so you have a better opportunity to closely monitor how they’re reacting. It’s much easier to learn if there are lots of patients in one place. But it can seem arbitrary, and people might see it as unfair if one hospital gets all of the drug available, while others get none.
How hard can it be to make more of these drugs and get them to patients who might benefit?
Right now [Mapp Biopharmaceutical Inc., maker of the experimental drug ZMapp] is only making enough for research. Scaling up manufacture of a drug poses some challenges. You can’t just double the recipe. Larger amounts may need to be mixed differently. And it’s expensive.
What kinds of things are important to monitor in the use of a drug not yet tested in people?
How much do you give? At what stage of the illness is the drug most effective? How are patients responding? The WHO made an interesting comment, that there’s a moral obligation on the part of the people who get these drugs to allow themselves to be studied, so that people can learn from this. That’s important.
Are there precedents for giving unapproved drugs to people?
Under American law, the Food and Drug Administration can permit a drug manufacturer to provide an unapproved drug to patients if they don’t have any alternatives and the consequences are severe. It’s called “compassionate use” and most of these exceptions are granted when the drug is in a clinical trial testing its safety, proper dose and efficacy.
The most profound example of this comes from the 1980s, in the early days of the AIDS epidemic. There was no approved drug that had any effect, and people were dying. Dr. Anthony Fauci [director of the National Institute of Allergy and Infectious Diseases] was key to changing this approach, and expanding access to AZT outside of clinical trials. But this is different in that the drugs for the Ebola virus have not yet entered clinical trials in humans.
Are new drugs the ultimate answer to controlling the spread of Ebola?
The real help will come from efforts to prevent the spread of disease. There’s no question that this is a disease that needs a public health prevention approach more than a medical drug treatment approach. In families where people are caring for one another, the more compassionate and caring they are, the more they risk getting sick themselves. The challenge is to isolate the sick; quarantine them; and take very careful precautions when treating the sick and burying people.
If you take precautions about being in close contact with the sick, you can stop the spread. You can stop the spread.