Despite the extraordinary gains in public health brought about by vaccinations, there has never been a shortage of people who balk at the scientifically proven method for preventing infectious disease.
Thankfully, the current measles outbreak has a new generation of naysayers in full retreat. The left-leaning families who prefer an all-natural lifestyle are being socially ostracized by their suburban soccer-mom peers. Sen. Rand Paul (R-Ky.), the physician leader of the “don't tread on me” right, was last seen rolling up his sleeve to get a booster shot at the Capitol. It's amazing how quickly presidential ambitions concentrate the mind when it comes to the core requirements of public health.
But as the Rev. Cotton Mather learned during Boston's smallpox outbreak in 1721, cutting-edge science often finds itself in conflict with popular prejudice or political ideology. Mather also received a hostile reception from the local medical establishment, which in those days relied on blood-letting to treat most ailments.
As the dreaded disease spread through what was then a town of 10,000, Mather was told by his slave Onesimus that some African tribes injected pus from a smallpox sufferer into the skin of healthy people to ward off the disease.
The Puritan preacher asked the 14-member local physician group, which was headed by Dr. William Douglass, to try it on the terror-struck population.
All but one—Dr. Zabdiel Boylston—rejected his entreaties. The controversy swirled for months in the weekly press (all posts anonymously written, of course), with the Douglass-led anti-vaccine faction cheered on by the New-England Courant, whose publisher was James Franklin, Benjamin Franklin's older half-brother.
The anti-vaccine crowd carried the day. Few people even learned about the approach (newspapers in those days reached only the upper crust of society). By the time the epidemic burned itself out, 5,889 of the city's estimated population of 10,000 had contracted smallpox; 844, or about 1 in 12, died.
There are good and bad reasons for the medical establishment to warm slowly to new approaches. In Mather's day, the idea of controlled clinical trials was unknown. Dr. Boylston, the one dissenter from conventional wisdom, inoculated his 6-year-old son and two of his slaves. All survived.
When Dr. Laurence Farmer of Lenox Hill Hospital in New York wrote his account of the 18th century controversy in 1958 (three years after the polio vaccine all but ended that childhood scourge), he noted “many regard (Boylston) as a farsighted innovator. To Douglass, with whom I am in full accord, Boylston's behavior appeared foolhardy, unscientific and rash.”
That's the same attitude that divided the Food and Drug Administration from its European peers when it came to testing experimental Ebola drugs during that recent outbreak, which is finally being brought under control. The World Health Organization sanctioned a trial of favipiravir that did not include a control arm.
The Japanese-approved influenza drug didn't have much effect on people in the later stages of the disease. But the first 69 people with low to moderate levels of Ebola virus had a 15% mortality rate, about half the expected 30% death rate. Local health officials called the results “encouraging.”
The FDA is under pressure on several fronts to loosen its clinical trial requirements for evaluating new drugs and medical devices. Last week, responding to more states moving to pass “right to try” laws, it sharply reduced the paperwork required for dying patients to gain “compassionate use” access to experimental drugs. The Republican-led Congress is gearing up for a revamp of FDA rules through a proposed 21st Century Cures Act.
It's important to make distinctions before changing the rules for collecting scientific evidence. As Cotton Mather and the WHO have shown, there is room to rethink how experimental therapies can be tried in emergency situations.
But not every new drug and device is innovative. Most are not aimed at the dying. The pleas of the desperate are no excuse for jettisoning the scientific method on most proposed new products.
