DESPITE THE HYPE, GILEAD'S REMDESIVIR WILL DO NOTHING TO END THE CORONAVIRUS
PANDEMIC
Sharon Lerner
May 26 2020, 1:05 p.m.
Remdesivir, an experimental antiviral drug made by Gilead Sciences, on the
table during a press conference at the University Hospital Eppendorf on
April 8, 2020, in Hamburg, Germany. Photo: Ulrich
Perrey/picture-alliance/dpa/AP
GILEAD SCIENCES' REMDESIVIR has been heralded as our best hope in fighting
the coronavirus pandemic. Unfortunately, the antiviral drug doesn't seem of
much help to patients with Covid-19, the disease caused by the coronavirus.
And while the company's clever rollout has generated excitement among
investors, politicians, and the public, a combination of generic drugs that
appears to be more effective in fighting the coronavirus has flown under the
radar.
Desperation for the limited supply of remdesivir is so great that Virginia
will hold a lottery to determine which of the almost 1,500 severely ill
patients in the state will be able to get its several hundred donated doses
of the drug. In Minnesota, state officials have come up with an action plan
to allocate their supply of the Covid-19 treatment, which calls for
designating "triage officers" who will randomly choose among equally
eligible patients. And in Alabama, physicians on a coronavirus task force
set up by the governor will determine which patients get remdesivir.
Some hospitals there will receive just a single course of treatment. Still,
Alabama's state health officer, Dr. Scott Harris, recently offered his
thanks to Gilead, the drug's manufacturer, which donated some 940,000 vials
of the drug to the federal government that are being distributed by state
health departments. "Although the total supply of remdesivir is limited, we
are grateful that hospitalized COVID-19 patients with severe disease in
Alabama can receive this potentially lifesaving medication," said Harris.
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It is amid these feelings of scarcity and indebtedness that Gilead is
setting the price for its antiviral medicine. The company, which has already
arranged for distribution of remdesivir in 127 countries, is expected to
begin selling it commercially as soon as June. And while a 10-day course of
the drug, which was developed as a potential Ebola treatment with at least
$79 million in U.S. government funding, costs only about $10 to produce,
according to an estimate by the Institute for Clinical and Economic Review,
its market price is expected to be several hundred times that amount.
Still, price gouging isn't what has many scientists upset about remdesivir.
It's the fact that the coronavirus drug that has boosted hopes and sent
Gilead's stock price (and according to some analysts, the entire stock
market) soaring doesn't seem to do much for coronavirus patients.
"Remdesivir doesn't work at all, as far as I can tell, or has only a minor
effect," said William Haseltine, a scientist who has spent decades studying
viruses and helped lead the U.S. government response to the HIV/AIDS
epidemic. "It is comparable to Tamiflu and maybe not even as good,"
Haseltine added, referring to another antiviral drug that has been available
by prescription for 20 years and is expected to be sold over the counter in
the coming months.
Haseltine, who founded the divisions of biochemical pharmacology and human
retrovirology at Harvard University's School of Public Health, pointed out
that Gilead hasn't released data showing remdesivir's effect on viral load
in people with Covid-19. Meanwhile, the only available information on how
the drug affects the amount of the coronavirus in patients, a Chinese study
of the drug published in The Lancet, showed that the drug did not lower the
viral load.
"That's why I call it the fuzzy-wuzzy drug," said Haseltine. "When the
Chinese tried to find the antiviral effect, it wasn't there."
Instead, the excitement about remdesivir is based largely on a study
sponsored by the National Institute of Allergy and Infectious Diseases that
showed people taking the drug had a faster recovery than those who didn't
take it: 11 days on average compared to 15 for those taking a placebo. An
article published on May 22 in the New England Journal of Medicine showed
mild improvement in hospitalized patients that took remdesivir, though the
drug didn't appear to be of any help to the sickest patients, who needed to
receive high-flow oxygen through ventilators or other means. Nor did the
drug significantly improve a patient's chance of surviving Covid-19.
Nevertheless, at an April 29 Oval Office press conference with President
Donald Trump, NIAID Director Dr. Anthony Fauci declared that preliminary
results from that trial proved that "a drug can block this virus." Since
then, remdesivir has been positioned as our savior and Gilead as its
benevolent dispenser.
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While some patients and their families have spent the past few weeks
frantically trying to procure remdesivir, another Covid-19 treatment has
been quietly been shown to be more effective. Although neither option
appears to be the much-needed cure for Covid-19, a three-drug regimen
offered a greater reduction in the time it took patients to recover than
remdesivir did. People who took the combination of interferon beta-1b,
lopinavir-ritonavir, and ribavirin got better in seven days as opposed to 12
days for those who didn't take it. Critically, the treatment has another leg
up on Gilead's: It clearly reduced the amount of the coronavirus in patients
who took it, according to a study published in The Lancet on May 8.
Yet so far there has been no stampede of patients demanding the new regimen
or lotteries to mete out the doses, which may be due at least in part to the
fact that the treatment hasn't been the subject of a major marketing
campaign. It's worth noting that each of the three drugs in the new
combination is generic, or no longer under patent, which means that no
company stands to profit significantly from its use.
In contrast, Gilead, a company that had more than $22 billion of revenue in
2019 and stands to make money from remdesivir for many years, has been
carefully orchestrating the rollout of its new treatment, doling out small,
tailored bits of encouraging information to the press and highlighting its
compassionate use program.
It's not unusual for pharmaceutical companies to paint their products in a
rosy light or go to questionable lengths to maximize profit. And Gilead,
which secured a lucrative orphan drug status for remdesivir in March before
reversing course two days later, has faced widespread criticism before -
particularly for the exorbitant pricing of its HIV medicine Truvada and
hepatitis C drug sofosbuvir, which sells for $1,000 a pill.
But during the pandemic, buzz, politics, and greed are playing an even
greater role than usual in determining which drugs are widely used while the
usual scientific process for evaluating their safety and effectiveness is
being sped up and curtailed. Trump, who whipped up excitement about the
malaria drug hydroxychloroquine, a drug he has taken himself despite not
having Covid-19, has led the way.
"You have a president putting intense pressure on companies, regulators, and
others in an effort to salvage his reelection," said Dr. Michael Carome,
director of health research at Public Citizen. The consequences, Carome
warmed, could be deadly. "My great worry is that with all this hype and the
press from the White House, that we'll bring something to market much too
quickly and harm a lot of people. That's the danger."
Already, the risk of death has been shown to be elevated in Covid-19
patients who take hydroxychloroquine. According to a study published in The
Lancet last week, the approximately 15,000 people who received
hydroxychloroquine or the closely related drug chloroquine were roughly
twice as likely to die as those who didn't take them.
The benefits of all drugs have to be balanced against their harms. In the
case of remdesivir, those dangers appear to include possible damage to the
kidney and liver. While the risks and benefits are typically clarified with
further study, the NIAID called off the remdesivir trial that might have
offered more information about both so that the patients who were getting
the placebo could take the drug.
In addition to possibly hurting patients, basing decisions about coronavirus
therapies and vaccines on hype rather than science also carries the risk of
prematurely investing in one product at the expense of another. "It's
possible that we're now investing a lot of effort in pursuing a drug that
could lead to less research being done on something that could have been
safer or more effective," Carome said about what he described as
questionable enthusiasm for remdesivir. After the drug received Emergency
Use Authorization from the Food and Drug Administration on May 1, Public
Citizen submitted a FOIA request for the complete data underlying the
decision. The FDA has not provided the group with any documents and usually
treats such data as proprietary.
Meanwhile, the excitement around another coronavirus development seems to be
moving faster than the science. Last week, the biotech company Moderna also
moved markets with a vague announcement about the preliminary results of a
study. In this case, the company described initial findings of a trial of
its potential coronavirus vaccine as "triumphant," though they were based on
eight people from a relatively early stage of research.
"Most products that pass this phase ultimately fail," said Public Citizen's
Carome. While the company summarized its data, it didn't release it. "We
need to see the details, but we probably won't."
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The vaccine development process promises to get faster and more vulnerable
to conflicts of interest. On May 14, Trump announced Operation Warp Speed,
the administration's effort to produce and distribute a coronavirus vaccine
by the end of the year, despite experts' insistence that the process will
likely take years. The operation is being led by former pharmaceutical
executive Moncef Slaoui, who has received more than $13.5 million from
pharmaceutical and biotech firms since 2016. Slaoui was also holding 155,000
shares of Moderna, whose value increased by more than $2 million after the
good news about its vaccine hit the airwaves. In an unusual arrangement, the
compensation for his government work is only $1 and is exempt from the usual
federal disclosure and conflict-of-interest laws. After Sen. Elizabeth
Warren called attention to his conflict of interest, Slaoui divested his
shares in Moderna and announced that he would donate to cancer research the
money he made off their increase after he joined Operation Warp Speed.
While vaccination may be the best hope to bring an end to the pandemic as
quickly as possible, mistakes made because of haste or conflicts of interest
could be devastating. Because the plan is to vaccinate some 1 billion people
worldwide, even infrequent side effects could manifest on a huge scale. The
wrong vaccines could even spread disease. "They could give you a nasty cold
that you could give to unvaccinated people," said Haseltine.
The current power of politics and greed over science make such outcomes more
likely. "I fear that the warp speed group will distort our regulatory
process and that the administration will put its thumb on the scale to favor
an outcome regardless of the cost to human life," said Haseltine. "People
think warp means very fast, but warp also means distorting."