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OPINION | The other way to hit back at covid-19

2020-08-05T21:34:19.184Z


Although distracting, the attention that hydroxychloroquine attracts poses a different but very important problem: what happened to the unrelenting search for a covid-19 cure in the United States?


Editor's Note: Kent Sepkowitz is a CNN medical analyst and infection control expert and physician at Memorial Sloan Kettering Cancer Center in New York. The opinions expressed in this comment are yours. See more opinion at CNNe.com/opinion

(CNN) - Hydroxychloroquine is back! And this time it has brought not only an outdoor discussion, but also aliens and demon sperm!

Yes, it's true, the so-called miracle cure for covid-19 that really isn't a cure at all is back in the news, thanks to President Donald Trump and a group of true believers, who are reaffirming their support for this wonderful whole.

Although distracting, the attention that hydroxychloroquine attracts poses a different but very important problem: what happened to the unrelenting search for a covid-19 cure in the United States?

Right now, we have 3 types of therapies for people with active infection, each with substantial limitations. Remdesivir is a new and expensive antiviral drug with modest benefit that needs to be given intravenously and is rare.

Dexamethasone is a powerful corticosteroid that has been around for decades. It is cheap and effective if you are sick enough, but it has not been shown to be useful for mild or moderate illness.

The third entry, convalescent plasma, has been around the longest. A version was given during the 1918 flu pandemic. It is inexpensive and available, but it requires a human source and must be administered intravenously. The optimal use of these three therapies, including administration of 2 or even all 3 together, has not been determined.

Only one of these drugs, Remdesivir, has an emergency use authorization from the US Food and Drug Administration, allowing use in people with "serious illness." Current evidence has not established that it provides patients with a survival advantage, although those who do survive recover faster.

It turns out that while we've all been talking about hydroxychloroquine and the tantalizing race for a vaccine one day, too often we've been derogatory about the real, not hypothetical, the good before us, direct treatment of the infection, like a Old high school friend you wish you never called.

Sure, the race for the vaccine is a great story, full of high-tech science, international intrigue, and a lot of money. Bare DNA and viral vectors and proteins are very good, but this does not mean that vaccines will solve the covid-19 pandemic any time soon.

Perhaps hopefully in a few months we will have a likely unsafe vaccine that shows some evidence of benefit for an uncertain duration in some patients. Maybe it's done in China or Russia or some other country with which we have relationship problems.

The FDA has hesitantly attempted to generate enthusiasm for its therapeutic program by renaming it under a new acronym. The Corona Treatment Acceleration Program, or CTAP, has a dashboard (last updated June 30) listing more than 510 therapies in the planning stages, more than 230 trials reviewed and considered by the FDA to be "safe to continue," 2 treatments that have received authorization for emergency use (including the now-terminated authorization for hydroxychloroquine) and zero approved agents.

For me, the explanation for the shortage of treatments currently under study is demonstrated in the second figure on the FDA website titled "type of treatment with covid-19 under study."

Of the trials considered safe enough to proceed, more than 70 are immunomodulatory and approximately 20 are high-tech gene and cell therapies. Neutralizing antibodies, scientifically similar to convalescent plasma, represent about 30 other tests.

The smallest developing group are antivirals, which turn out to be the only proven effective way to treat viral infections. We have effective antivirals for many diseases, including herpes (simplex and zoster), HIV, hepatitis B, and hepatitis C.

These medications have saved lives and reduced transmission of infections. However, a look at the 298 active US interventionist trials listed at clinictrials.gov shows a pronounced lack of antivirals under study.

The antivirals tested so far are retreaded, developed for other diseases. This makes sense: looking for ready-made medications is the first order of business in an emergency. These include lopinavir-ritonavir (Kaletra ™), an approved drug for HIV infection that was not effective for covid-19; oseltamivir, a flu medication that also fell short against covid-19; and remdesivir, which was developed to treat Ebola.

Still under study are favipiravir, approved in Japan for influenza years ago, although little used, which is currently in phase 2 trials in the US for covid-19 and LAM-002A infection, previously tested in the treatment lymphoma, which can interfere with the attachment virus and be useful early in covid-19. Some others are also taking a look.

Certainly, the time required to develop medications is long. So, the development of a vaccine.

So why is it slow? Granted, few of the deaths in covid-19 infection are directly from viral invasion. Covid-19 kills causing overwhelming inflammation that damages the heart, lungs, brain, and blood vessels. Inflamed blood vessels promote clotting.

One could argue that treatment to mitigate the downstream effect of the virus, rather than the virus itself, may be appropriate.

In fact, a government-industry partnership called ACTIV (Accelerating Covid-19 Therapeutic Interventions and Vaccines) has prioritized reducing inflammation and clotting, as well as synthetic products that mimic the effect of convalescent plasma.

I imagine this approach is due less to scientists' views on the cause of death and more to the notion that a drug for a disease really doesn't work anymore, at least from a commercial perspective.

The main interest is to develop "platforms" for a broader discovery, such as playing with the immune system, where the knowledge of covid-19 can be applied to additional diseases, such as cancer or arthritis.

This is a great long-term trading strategy, but wrong in the midst of a crisis. When the house is on fire, he wants the best fire hose, not a disruptive technology that promises a new way to separate water into component molecules that can be sent to a tank 1,000 kilometers away at the speed of light, reconstituted and scatter over the flames.

The latter approach, if successful, can change society as we know it; but in principle it will prevent people from dying.

With over 4.5 million cases of covid-19 in the U.S., and more than 150,000 deaths in just 7 months, it's time for the brilliant dreamers who run our science labs to do what seems impossible: change the heading and start thinking small.

remdesivir

Source: cnnespanol

All news articles on 2020-08-05

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