The fight over whether chloroquine should be used before the Food and Drug Administration approves its use for coronavirus has become political and ugly. In particular, the media is angry because it believes the Trump administration supports increasing “access to promising drugs to patients who cannot participate in clinical trials.”
There are dozens of articles claiming that “allowing widespread use for infected people is simply a matter of acquiescing to political pressure.” An op-ed in the Los Angeles Times called for limiting access to clinical trials. And a recent New York Times article noted that allowing people to get access to medicines such as hydroxychloroquine is “an invitation to disaster. It will prevent us from finding drugs that will help people.“
Except these are not contemporary allegations about hydroxychloroquine. They are statements and sentiments lodged about HIV medications and the AIDS patient 30 years ago as they fought to get access to experimental medicines.
The government official urging broader access at the time? Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases who is currently a very visible part of the President’s Coronavirus Task Force.
HIV was identified as a potentially deadly virus in 1981. By 1982 it was clear that the disease was spreading around the globe, killing almost everyone it infected. Like today, HIV patients quickly developed pneumonia and respiratory infections.
After aggressive and militant confrontations with the FDA and the National Institutes of Health, AIDS activists forced the accelerated approval of AZT in 1987. This first drug showed some ability to slow HIV progression. (Under accelerated approval, drugs that showed effectiveness in a first round of clinical trials could be approved.)
But AIDS activists wanted to expand the evaluation of other potential HIV drugs beyond people who were enrolled in clinical trials. In 1990, they “collaborated with Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases (NIAID) to come up with a plan called ‘parallel track.’” Under the parallel-track system, patients could receive drugs if they were unwilling or unable to participate in the typical clinical trial.
Parallel track studies began in 1992. Patients were treated by their doctors, who reported back to the FDA and drug developers, telling how they had fared. The data, as it turned out, generated more insights on how to treat patients than those obtained in a “gold standard” clinical trial.
Researchers and activists used these robust findings to develop new medicines quickly, customizing combinations of anti-virals to specific patients. By 1993, the number of AIDS cases peaked and began a dramatic decline — as did the number of people dying. It would have taken a decade to achieve such results relying on the kind of traditional clinical trials the media want to impose on people infected with the coronavirus.
Clinical trials for hydroxychloroquine can be conducted while community studies are taking place. There is no reason not to re-institute community-based parallel track programs for hydroxychloroquine and every reason to do so. Billions of people around the world have used hydroxychloroquine for 65 years, so there’s no problem there.
Parallel track drugs must show preliminary evidence of efficacy in small groups of patients. Hydroxychloroquine fits that criteria. There are several small studies and hundreds of individual cases with data demonstrating it slows the course and reduces the symptoms of the disease. Some claim that the drug only reduces the spread of the virus. Even if true, isn’t slowing the spread of infection important as well?
In 1991, people were collecting information using handwritten index cards, composition notebooks and medical records. Today, important data can be collected and analyzed electronically.
In the next couple of weeks, the number of people tested for coronavirus, especially in high impact areas such as New York City, will be in the millions. Rather than wait for randomized trials to be established in academic centers where only a few can participate, test results should trigger enrollment in a parallel track study. Novartis, Teva and Mylan are already ramping up production to ensure there are hundreds of millions of doses available.
In 1990, Dr. Fauci told critics that “[We are trying] ultimately to get drugs proven to be safe and effective or unsafe and ineffective … On the way to that, we have to take into consideration the needs of people who don’t have any other options. We can be humanitarian and do good science.” That approach helped to turn the tide against HIV. We must pursue the same strategy against coronavirus today.
• Peter J. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest.