Saturday, April 18, 2020

Cure, maybe, but not proof that capitalism will solve all your problems

Image via Freedom From Religion Foundation.

This week's news of a remarkably successful early trial at the University of Chicago for a possible Covid-19 drug, Gilead's Remdesivir, is really good, let me say that, but I'm not so sure about Mr. Bret Stephens and his panegyric to pharmaceutical profit (The Story of Remdesivir")—
Just as there are no atheists in foxholes, there should be no big-pharma haters in pandemics. Last year, Elizabeth Warren wrote that “giant drug companies only care about one thing: raking in profits on the backs of patients.” I wonder if the Massachusetts senator would have the nerve to say that to [Gilead clinical research head Diana] Brainard and every other private-sector scientist laboring to find cures under the intense strain of this global emergency.
—and their beneficent employers,
profit-seeking companies operating in fiercely competitive and well-regulated marketplaces. Whatever the fate of remdesivir or any other drug, one lesson from this pandemic is how dependent we are for our survival on an innovative and robust pharmaceutical industry. Maybe we should do more as a country to cultivate it than tear it down.
As a matter of fact, Gilead has had plenty of cultivation from our federal government, in particular with respect to Remdesivir, starting with the CDC in 2014 pulling it out of a "library" of some 1000 possible antiviral compounds the company had been patenting over some decades, as a possible treatment for Ebola, refined with the full collaboration and financial support of the the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) whose scientists did the actual testing of the drug's effectiveness in cell cultures and 100 rhesus monkeys who all survived the disease.


Further study at the nation's first public university, UNC Chapel Hill, plus the private Vanderbilt and an agency, AD3C, based at the public University of Alabama at Birmingham, found that the compound was also promising for two coronavirus diseases, SARS and MERS:
The results of the Rhesus monkey study led scientists with the University of North Carolina - Chapel Hill, Vanderbilt, and Gilead (coordinated by the Antiviral Drug Discovery and Development Center, or AD3C) to investigate GS-5734 as a candidate for treating Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS), which are caused by coronaviruses. More specifically, COVID-19 belongs to the Betacoronavirus genre of 9 the Coronaviridae family, which includes SARS-CoV and Middle East respiratory syndrome CoV (MERS-CoV).The scientists found that the compound prevents replication in a wide range of coronaviruses in human lung cells and that it is effective against SARS-CoV in mice... 
funded by upwards of $34 million in National Institutes of Health grants. The first human tests of Remdesivir were run by the Royal Free London NHS Foundation Trust and the US National Institute of Allergy and Infectious Diseases (NIAID); Gilead generously provided the Remdesivir itself free of charge in at least some of the cases, as part of the company's "compassionate use program". The total US government funding for its development, according to calculations by The Intercept that I see no reason to doubt, was upwards of $79 mlllion by early this year.

After the outbreak of Covid-19 in Wuhan, Chinese scientists began looking at Remdesivir as a possible treatment for that, and began an extensive series of studies starting 6 February; one of Gilead's responses to this, in late March was to ask the US government for another special favor, the classification of Remdesivir as a so-called "orphan drug"—one that is appropriate for too few Americans to be profitable, in theory (under 200,000 patients—and awarding the company certain compensatory rights, like stopping other countries from producing generic versions. Once it became clear that the new coronavirus was about to blow up in the US to affect many more than 200,000, they dropped that, though they still have 20-year patent rights on it in more than 70 countries.

Gilead doesn't, by the way, have a very good record for not profiteering:
Several class-action lawsuits have been filed against Gilead over allegations that the company deliberately delayed development of antiretroviral drugs based on tenofovir alafenamide fumarate (TAF) in order to maximize profits from previous-generation medications containing tenofovir disoproxil fumarate (TDF).[65] Plaintiffs allege that Gilead suspended TAF in 2004 despite clear evidence indicating that TAF-based medications were safer than TDF, a compound whose long-term use was associated with adverse side effects such as nephrotoxicity and bone density loss.[66][67] Gilead intentionally withheld results of clinical trials demonstrating TAF's relative safety and efficacy and shelved TAF-based therapies until 2010, when the Food and Drug Administration approved Gilead's application to patent TAF.[68] Gilead's first TAF medication, marketed under the trade name Genvoya, came out in 2015. In the interim period, many HIV patients who continuously took Gilead's older TDF-based drugs suffered permanent, debilitating kidney and bone damage, often developing conditions such as Fanconi syndrome and osteomalacia.[69]
Gilead has come under intense criticism for its high pricing of its patented drug sofosbuvir [used for hepatitis C,. for which it has a cure rate of between 30% and 97%]. In the US, for instance, it was launched at $1,000 per pill or $84,000 for the standard 84-day course.[20][70]
While The Intercept notes that
Gilead also sells Truvada, a drug to help prevent the transmission of HIV, for almost $2,000 a month despite the fact that it costs only $6 to manufacture.
In the case of Covid-19, the "compassionate use" program seems to have been dropped too as large-scale human testing begins, and the company is charging something like $20,000 per patient, for a total of $157 million, all of which (except for their own 1,000 out of 7,855 subjects or 13% of the total) is fronted by Chinese, US (NIH), and French governments.

I'm going through all this because Mr. Bret rushes past it, wouldn't you know, in the impersonal construction:
Lab tests, however, suggested it might have potent effects against coronaviruses such as those that cause SARS and MERS. As it became clear that Covid-19 was also caused by a coronavirus, remdesivir was one of the only potentially helpful drugs ready to be in clinical trials. Gilead began distributing it on a compassionate-use basis on Jan. 25.
(And suspended it on 23 March, except for critically ill children and pregnant women, on the grounds that they might not have enough supply, which Gilead can't easily control, since they're famous among pharma giants for refusing to manufacture their own products.) He makes no reference whatsoever to the public agencies that discovered this stuff in the Gilead "library" and thought of things they could try to do with it, and are right now doing nearly all the work of finding out what it will actually do.

Long and short is, we should by all means be hopeful about the potential of this medicine (not before the November election, though, Trump can stop expecting it to save his ass, and so can Mr. Bret if that's what he's thinking), but there's no need to fall down and worship Gilead over their role. (Like Microsoft, Gilead is far better known for acquiring companies for their innovations than for coming up with its own, anyway.) It's public money (aka socialism) and public employees that have done the overwhelmingly largest share of the work.

Research suggests that there are some atheists in foxholes, and also that mistrust in the beneficent humanity of drug companies may not be misplaced.

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