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Fool me twice…

If you thought you were having a Déjà vu experience this weekend, it might be because you’ve been reading about Remdesivir; the proprietary drug that its sponsors are desperate to convince you is a cure for the Covid-19 pandemic.  The reason why media coverage of this drug should be ringing alarm bells is that it has all of the hallmarks of the 2009 Tamiflu scandal.

In 2009, you will remember, the world faced another – potentially life-threatening – pandemic; the “Mexican Swine Flu.”  As early reports of the new strain of influenza came in, so the various modellers who are paid to predict these things, began to talk about millions of deaths worldwide if the virus wasn’t contained.  Understandably, governments around the world began to consider the likely impact of a large number of random deaths on critical infrastructure.  Healthcare workers, for example, have long been known to be at far greater risk than the population at large during a pandemic.  Meanwhile the death of, say, a handful of the engineers whose jobs include keeping the local nuclear power plant from exploding could be a seriously detrimental outcome.  If only there was an antiviral drug that could be easily administered to prevent these deaths and to shorten the duration of the illness.

Enter “Big Pharma” in the shape of multinational corporation Roche.  The company assured the world that its proprietary drug – Tamiflu – could save lives and shorten the duration of the illness.  And so governments around the world set aside the austerity programmes intended to recover the money used to bail out the banks, and began spending with abandon.  In December 2009, Shannon Brownlee and Jeanne Lenzer at the Atlantic drew attention to the scandal:

“Two months ago, we pointed out in our story on flu in The Atlantic that the antiviral drug Tamiflu might not be as effective or safe as many patients, doctors, and governments think. The drug has been widely prescribed since the first cases of H1N1 flu surfaced last spring, and the U.S. government has spent more than $1.5 billion stockpiling it since 2005 as part of the nation’s pandemic preparedness plan.

“Now it looks as if our concerns were correct, and the nation may have put more than a billion dollars into the medical equivalent of a mirage. This week, the British medical journal BMJ published a multi-part investigation that confirms that the scientific evidence just isn’t there to show that Tamiflu prevents serious complications, hospitalization, or death in people that have the flu. The BMJ goes further to suggest that Roche, the Swiss company that manufactures and markets Tamiflu, may have misled governments and physicians…”

The UK government also spent millions of pounds stockpiling a drug which was no more effective than paracetamol in treating Swine Flu.  As General Practitioner, science writer and clinical trials campaigner Ben Goldacre wrote in the Guardian:

“Today we found out that Tamiflu doesn’t work so well after all. Roche, the drug company behind it, withheld vital information on its clinical trials for half a decade, but the Cochrane Collaboration, a global not-for-profit organisation of 14,000 academics, finally obtained all the information. Putting the evidence together, it has found that Tamiflu has little or no impact on complications of flu infection, such as pneumonia.

“That is a scandal because the UK government spent £0.5bn stockpiling this drug in the hope that it would help prevent serious side-effects from flu infection. But the bigger scandal is that Roche broke no law by withholding vital information on how well its drug works. In fact, the methods and results of clinical trials on the drugs we use today are still routinely and legally being withheld from doctors, researchers and patients…”

Alarm bells began ringing when the media launch of Remdesivir as a possible treatment for Covid-19 included several similarities to the way Tamiflu was over-sold at a time when governments and populations were understandably desperate to find a means of halting or mitigating a pandemic.  First, and unlike a Chinese study reported in The Lancet, the data from the trial conducted by Remdesivir’s owner Gilead has not been made public.  Instead, considerable weight has been given to the four-day difference in recovery time in a trial which, unlike the Chinese study, was neither controlled nor randomised.  Importantly, there was no difference in outcome if the drug was administered at a late stage and there was no statistically significant difference between the death rate with Remdesivir compared to treatment as usual.  Indeed, the Chinese study shows a slightly higher death rate in the Remdesivir group compared to placebo.

Given the high cost – more than $1,000 per dose – of Remdesivir, even the company’s offer to donate the first million doses is less generous than it might first appear.  It won’t cost the company anything near what it charges to produce the drug.  And if – like Roche in 2009 – it can persuade western governments to stump up billions of dollars to stockpile the drug, it stands to make enormous profits.

An additional worry which ought to have the establishment media asking serious questions (they won’t) is the high number of conflicted science advisers on the COVID-19 Treatment Guidelines Panel which is recommending Remdesivir for public use.  Sixteen of the panellists have declared financial support from the pharmaceutical industry.  Of these, nine receive funding from Remdesivir‘s proprietor, Gilead Sciences.

Ben Goldacre’s conclusions about Tamiflu should be front and centre in any article about Remdesivir today:

“Should we have spent half a billion on this drug? That’s a tricky question. If you picture yourself in a bunker, watching a catastrophic pandemic unfold, confronting the end of human civilisation, you could probably persuade yourself that Tamiflu might be worth buying anyway, even knowing the risks and benefits. But that final clause is the key. We often choose to use treatments in medicine, knowing that they have limited benefit, and significant side-effects: but we make an informed decision, balancing the risks and benefits for ourselves… But the results of clinical trials are still being routinely and legally withheld…”

Before anyone thinks of offering Gilead Sciences what would be a licence to print money, they should demand that every scrap of trial data is openly available in the public domain.  Only then can we assess whether this drug is worth a price tag which, once the cost of shutting down the economy falls due, we will struggle to afford.  As the old saying has it; “fool me once, shame on you.  Fool me twice, shame on me!”

As you made it to the end…

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