Cutting corners on a coronavirus vaccine could cost lives

In the desperation to save lives in the coronavirus pandemic, we have already begun to relax scientific standards in the hope of finding a treatment without waiting to prove that it works.

Bioethicists have proposed risky human-challenge trials — which expose volunteers to the virus — to speed coronavirus vaccine development, and the Trump administration has already let one vaccine maker skip the usual requirement for animal safety trials before injecting an unproven vaccine into the arms of human volunteers.

The World Health Organization has funded a trial of new drug therapies that shockingly has no placebo-control arm.

And, of course, the experimental and potentially dangerous use of hydroxychloroquine in Covid-19 patients already boasts the presidential seal of approval and has become commonplace in American hospitals.

The next scientific corner to cut is clear.

Influential authors from the Coalition for Epidemic Preparedness Innovations recently wrote in The New England Journal of Medicine that “in a high-mortality situation, populations may not accept randomized, controlled trials with placebo groups.” While placebo-controlled multivaccine trials may be one solution, they wrote, another would be to skip the placebo.

This wouldn’t be the first time doctors took a chance on an unproven vaccine on a mammoth scale.

Read more in my new article at The New York Times.

Vaccines just aren't as easy to discover as they used to be

Edward Jenner had it easy. Swab some cowpox in 1796, scratch the nastiness into the arm of a little kid (see below), and, PRESTO, instant immortality. 

Vaccine success after vaccine success followed. Measles, mumps, rubella, polio... one after another global scourge quaked before the mighty pipettes of vaccine researchers.

I admit, the stalwarts who discovered those vaccines did more than transfer cow-pus to an un-consented minor research subject prior to doing a victory lap around the farm. Rather, they earned their laurels by working hard, and by being brilliant.

But ease wrought hubris, and as deadly viral menaces fell in succession, you could forgive one noted twentieth century sage, US Surgeon General William Stewart (pictured below), for saying, "It’s time to close the books on infectious diseases, declare the war against pestilence won, and shift national resources to such chronic problems as cancer and heart disease."

Whoops!

These early triumphs gave way to a long, hard slog. Vaccines against HIV, tuberculosis, herpes, staphylococci, and hepatitis C, among others, have proven far more elusive. Amid small successes, and spectacular failures, we have discovered an uncomfortable fact: we don't really know what makes a good vaccine tick. 

This week I was glad to contribute both heat and noise to the mix. In an op-ed in the Health Affairs blog, I write about the dangers of dogmatism and the lessons learned on the road to a new HIV vaccine. And, we also published preclinical data this week on a new scalable version of our tuberculosis vaccine. Data from our Phase 1 trial of the same vaccine should come out soon!

Who knows if all this will lead to glory. Probably not! Either way, it's been a pleasure to try. 

Is a clinical trial of therapy for mothers with HIV unethical?

A global health controversy erupted this summer when the prominent scientific journal Nature ran an article entitled “HIV trial attacked.” Within, commentators squared off over whether a huge ongoing study provides suboptimal and thus unethical treatment options to mothers with HIV in the developing world.

To read more, see my new post at Health Affairs.

The ethics of research in low and middle income countries

Many developed world academic institutions are forming international partnerships to improve clinical care, education and research in developing countries. This is a great development, and one I hope will last even when it is no longer trendy. But, particularly the conduct of research in developing world countries brings with it ethical complexities: it's cross-cultural, there are power gradients, and sometimes researchers are motivated more by pecuniary gain than true altruism. To help manage these risks, so our outreach can be most effective and least undermined by such factors, I wrote a review of the history and approach to the ethics of research in low and middle income countries.