Friday, May 1, 2020

Vaccine Risk Shift to Taxpayers

Context
When drug makers ramp up drug or vaccine production before clinical trials and data analyses are complete, it is called “at risk” production. The risk lies in the FDA’s refusal to approve the drug or vaccine on safety and/or efficacy grounds. All drug and vaccine production is usually costly, so the risk tends to be high. Companies tend to hesitate to produce at risk unless they are confident about their safety and efficacy data. The upside of at risk production is that once FDA approval is received, product sales can occur almost immediately after approval. Each day of sales protected by either market exclusivity or patents is precious. Each day can be worth millions in profit to a company.


Risk shift
The Washington Post reports that under a federal government effort, called “Operation Warp Speed”, taxpayers will assume the risk of at risk production of Covid-19 vaccine. That seems like a dumb name. Maybe the president dictated it. It sounds like him. Whatever.



Operation ludicrous speed

The downside is that taxpayers will have to pay the cost of at risk production if the vaccine fails to be sufficiently safe or effective. The upside is that if a vaccine does get FDA marketing approval, it can be at least fairly widely available within a few weeks. The goal of the effort is to have a vaccine publicly available by January of 2021. If that timeline pans out, it would be an amazing research and production achievement in such a short time.

The risk shift to taxpayers illustrates a key aspect of America’s for-profit healthcare system. Namely, it is a for-profit industry. Companies will not take risks that do not pass muster with internal company reviews, even if the risk could save many lives. Taking excessive risk can open a company and its executives up to shareholder lawsuits. Shareholders hold shares to make money, not to make people safe. That is the cold, hard reality of American healthcare. Profit, not service to the public interest, is the overwhelming moral imperative of capitalism.


Incoherent, self-serving drivel from our endlessly blame-shifting Blitherer-in-Chief
Naturally, the president chimed in. WaPo writes:
“President Trump said it is not too optimistic to try to produce roughly 300 million doses of vaccine in eight months, enough for the entire country.

‘No, I’m not overpromising. I don’t know who said it, but whatever the maximum is, whatever you can humanly do, we’re going to have. And we hope we’re going to come up with a good vaccine,’ the president said at the White House.

He added that ‘we’re going to fast-track it like you’ve never seen before, if we come up with a vaccine.’

Asked who is in charge of the effort, Trump said he is. 
‘I think probably, more than anything, I’m in charge. And I’m the one that gets blamed. And I get blamed anyway,’ Trump said.”

“I don’t know who said it.” That pretty much sums up the president’s grasp of things like science, the Covid-19 pandemic and reality in general.

“I think probably, more than anything, I’m in charge.” Probably in charge? Har, har, har! He will claim to be in charge if the effort works. But it will be the fault of Obama, Hillary’s Benghazigate and/or emailgate or something like that if it fails.

Sarcasm: Russia, if you’re listening, please find the missing emails. That is where Covid-19 came from and the vaccine recipe is in there too. Ludicrous speed on that hacking, please.

The fact that the president waited this long to jump to warp speed does mean he will be blamed for the needless delay because the delay was needless and he should be blamed. Why do this now and not three or four months ago? That inexcusable incompetence-driven delay is on the president, not Barak, Hillary, Pelosi, Schumer, the New York Times hidden emails or anything or anyone else.

Even at this very late date, the president clearly does not grasp the scope or gravity of what America is facing right now. He is amazingly clueless.


A sincere wish for the future
Maybe one day, the news won’t be so endlessly bad and idiotic. Maybe one day American politics will return to some reasonable degree of coherence and some reasonable grounding in facts, sound reason and transparent accountability. I do not know when that day will be, but I hope it is very soon.

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