The U.S. could learn a lot from Britain.
By Ezekiel J. Emanuel, Cathy Zhang and Amaya Diana
The New York Times, September 1, 2020
Americans and American biomedical researchers have often prided themselves on conducting the best clinical research in the world. Yet with over six million coronavirus cases and 183,000 deaths, the United States has produced little pathbreaking clinical research on treatments to reduce cases, hospitalizations and deaths. Even one of the most important U.S. studies to date, which showed that the antiviral drug remdesivir could reduce the time Covid-19 patients spent in the hospital to 11 days from about 15, had too few subjects to demonstrate a statistically significant reduction in mortality.
Progress on therapeutics research has been a very different story in Britain. In mid-March researchers there began a randomized evaluation of Covid-19 therapies, known as Recovery, that involves every hospital in the nation. The goal was to conduct large, rapid and simple randomized trials to define standard treatment. Some 12,000 patients were quickly randomized — that is, assigned by chance to receive different treatments — and within 100 days of the effort’s start, researchers made three major discoveries that transformed Covid-19 care worldwide.
Researchers found no benefits from the use of hydroxychloroquine in hospitalized Covid-19 patients, nor from the lopinavir-ritonavir drug combination. On the other hand, dexamethasone, an inexpensive steroid, was found to reduce mortality by up to one-third in hospitalized patients with severe respiratory complications. Each of these results was conclusive and went against the expectations of many clinicians, guideline writers and lay advocates. The results demonstrated the critical need for randomized trials to separate drugs we hope work from treatments we know work.
In the United States, by comparison, the government-sponsored Patient-Centered Outcomes Research Institute has spent millions of dollars creating a large clinical research network but has produced no research results on Covid-19 therapeutics.
As the United States designs research protocols to investigate clinical therapeutics, we should ask: What has gone right in Britain that the United States can adopt to help rapidly and definitively identify Covid-19 therapeutics that really work, and just as important, those that don’t?
Maybe the most important factor is an attitudinal difference: British clinical researchers have a longstanding commitment to large, simple and rapid randomized trials. American researchers prefer smaller, selective and complex trials with many restrictions on patients who can enroll.
First, the Recovery trials are designed to be easy to take part in, with paperwork that is short and simple.
Second, the Recovery protocol was quickly approved at the national level and adopted by all hospitals in Britain.
Third, background patient data provided by the National Health Service helped to simplify the research process.
Fourth, support from leaders in government health care ensured widespread cooperation by hospitals.
Fifth, Britain has a national system of research nurses who were rapidly redeployed to work on Covid-19 research.
And last, the British effort was incorporated as part of everyday clinical care in hospitals. The alternative, of haphazardly trying anything and everything, which seems to have been the American way, was rejected in Britain because it neither optimizes patient care nor generates useful data.
An additional feature worth noting about the Recovery effort is that it has been relatively inexpensive to conduct.
Unfortunately, unlike Britain, the United States has lacked a clear, unified message from government health care leaders, major insurance companies and hospital systems to put in place large, simple randomized trials that are considered the standard of care for Covid-19 treatment. We need to change that muddled approach now and reassert the nation’s clinical research excellence.
By Don McCanne, M.D.
The United States spends the most money on health care, yet we have failed to prevent the expansion of the Covid-19 pandemic and the deaths that have resulted. Although we should be leading the world in the urgent research needed to treat and prevent the spread of this disease, our progress, when compared to that of Britain, has been worse than disappointing.
Ezekiel Emanuel and his coauthors suggest that we could learn from Britain, and they list features that we should consider to improve our efforts. However, in their list, they may have missed the forest for the trees.
Britain has a public health system whereas ours is largely private even if heavily subsidized with public funds. Their system is designed to serve patients whereas our system is designed on a business model. That applies to research as well. Their research again is predominantly designed to serve patients whereas our research is designed to corner markets with leveraged high prices. Thus Britain’s research is coordinated whereas ours is fragmented into sectors that are competing to get the earliest control of the largest and most expensive sectors of the market. In health care, Britain shows us that cooperation is the key to success whereas, in our devotion to the false promise of competition, we continue to show that we drive prices up, not down, while leaving tens of millions without adequate care.
We may not be ready to nationalize our health care delivery system but at least we could socialize our insurance through the single payer model of an improved Medicare for All. With public funds administered through a public financing system, we could make better use of our NIH, CDC and even the WHO. If we had responsible public stewards who supported solidarity and cooperation, we would be much further along in our recovery from this pandemic.
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