The Risks of Outsourcing Immunity to the Private Sector

On the phone, during a short break from comforting her daughter who was suffering from swine flu, my sister tells me: “I am so angry at our government!” Now, this is not a woman who routinely turns to the government for help. She votes Republican, largely on fiscal grounds. But my sis has been trying for weeks to track down some vaccine, to no avail. She’s pissed. And like me, she sees that the government promised far more vaccine than it’s been able to deliver.

We here in Athens, Ohio, may yet get ours. My husband “got shotted,” as the Tiger says, last weekend, but only after passing through a strict triage protocol. Both the Tiger and the Bear are slated to get the intranasal spray on Monday at school. Originally I’d promised to accompany them – they’re both scared of needles – but they know how to “sniffle it up,” for which I’m grateful, since their immunization clinic overlaps with teaching times for both my husband and me.

And yes, since both kids are still slated for immunization, this means that we “have swine,” in the terms of my worried post two days ago, and we do not actually have swine flu. (Did I just bury the lede?) The Tiger spiked a vigorous fever at the start of a very mild cold. He stayed home yesterday out of an excess of caution. Today he went back to school his usual energetic, ornery self.

Judging from the hurried exchanges I had with other parents at tonight’s school carnival, many of us have been worried, and most of us are grateful that our kids are in line for the vaccine.

But my sister is right. These delays are unconscionable. Worse, they’re not even necessary. In Alternet, Barbara Ehrenreich writes:

In July, the federal government promised to have 160 million doses of H1N1 vaccine ready for distribution by the end of October. Instead, only 28 million doses are now ready to go, and optimism is the obvious culprit.

“Road to Flu Vaccine Shortfall, Paved With Undue Optimism,” was the headline of a front page article in the October 26th New York Times. In the conventional spin, the vaccine shortage is now “threatening to undermine public confidence in government.” If the federal government couldn’t get this right, the pundits are already asking, how can we trust it with health reform?

But let’s stop a minute and also ask: Who really screwed up here — the government or private pharmaceutical companies, including GlaxoSmithKline, Novartis, and three others that had agreed to manufacture and deliver the vaccine by late fall? Last spring and summer, those companies gleefully gobbled up $2 billion worth of government contracts for vaccine production, promising to have every American, or at least every American child and pregnant woman, supplied with vaccine before trick-or-treating season began.

According to Health and Human Services Secretary Kathleen Sebelius, the government was misled by these companies, which failed to report manufacturing delays as they arose. Her department, she says, was “relying on the manufacturers to give us their numbers, and as soon as we got numbers we put them out to the public. It does appear now that those numbers were overly rosy.”

If, in fact, there’s a political parable here, it’s about Big Government’s sweetly trusting reliance on Big Business to safeguard the public health: Let the private insurance companies manage health financing; let profit-making hospital chains deliver health care; let Big Pharma provide safe and affordable medications. As it happens, though, all these entities have a priority that regularly overrides the public’s health, and that is, of course, profit — which has led insurance companies to function as “death panels,” excluding those who might ever need care, and for-profit hospitals to turn away the indigent, the pregnant, and the uninsured.

(Read the rest here. She takes a couple of cheap swipes at drugs for ED and restless legs, but the rest is worthwhile.)

Exactly! We cannot expect a for-profit system to maintain massive facilities for producing vaccines that are needed only irregularly. So much of our economy relies on just-in-time deliveries. The pharmaceutical industry is no different – except that its “just-in-time” model for vaccines assumes several months’ lead time while moving from one seasonal flu virus into the next most likely mutation. The current system has no capacity for faster responses when a pandemic strikes.

You don’t have to adopt Ehrenreich’s basically socialist convictions to see that when vaccines mix with free enterprise, the results are bound to be deadly. On the one hand, delays are inevitable because profit-making enterprises cannot justify to their shareholder the massive “excess” capacity required to produce vaccines in a fast-moving and potentially highly virulent pandemic. This is capacity that must otherwise lie idle. On the other hand, as long as vaccine production is privatized, the pharma companies will beg for immunity from lawsuits in cases where rare side effects may have caused lasting harm. Even if these companies are fully indemnified, they’ll still have a strong disincentive to publicize such adverse effects, which can only bring bad PR.

Imagine, now, that instead of this swinish H1N1 we were instead facing a highly communicable mutation of the already horribly virulent H5N1 (bird flu). Even assuming the virus lost some virulence in exchange for better transmissibility, millions and tens of millions would be dead before any vaccine were available. And suddenly, the same pharma companies who’ve found vaccines to be unprofitable would be able to demand, essentially, menace money. They could charge whatever the market would bear. And the market could bear a hell of a lot. Seriously, how much would you be willing to spend on a vaccine that gave you any hope of escaping the near-lethal consequences of bird flu? How do you value the preservation of an individual loved ones’ life? What price would you put on your own life?

In short, a free market is bound to fail every whichway when it comes to vaccine production. The government needs to get involved, either by establishing strict regulatory standards, or – more likely, since regulation will push manufacturers to withdraw from an already risky market with low profits – by taking over production itself.

Infuriatingly, the technology for producing more vaccine faster already exists – just not in this country on the grand scale we’d need. Ehrenreich links to ex-Senator Bob Graham on this point, who notes that speedier technologies already exist; the U.S.  just hasn’t pursued them aggressively enough:

Part of the slowness is due to the fact that all six US manufacturers of flu vaccine use chicken eggs. A modern and faster method to make a safe flu vaccine uses a process called “cell culture.” Cell culture does not require eggs. Vaccines for polio and the modern smallpox vaccine have been produced for decades using this technology.

Abandoning chicken eggs for cell culture has several advantages:

• Rapid scale-up in production would be possible.
• Egg-specific steps in the production process would be removed, saving time.
• Vaccine can be given to people who are allergic to eggs.
• Chickens are susceptible to avian influenza infections, which could disrupt the supply chain of eggs and cripple vaccine production.

The U.S. has invested in cell culture technologies, but none are yet available.

(More here.)

We could also be taking advantage of adjuvants, which are essentially biochemical accelerators for vaccines. Revere at Effect Measure has been advocating for exactly this. He writes:

Europe’s adjuvanted flu vaccines don’t appear to be any less safe than non-adjuvanted ones and are far more effective and efficient in the use of the scarce active ingredient, the viral antigen. It is availability of viral antigen that is limiting vaccine production. Unadjuvanted vaccines require much more viral antigen than those with adjuvants.

(Do read the rest! I promise it’s highly accessible to non-specialists.)

Adjuvants aren’t new or untested. They’ve been used for years in Europe. Their safety profile is good. They could help us stretch our supply of vaccine not only in the U.S. but also in poor countries that will otherwise likely be last in line.

All of this wisdom comes too late for the current pandemic – though it’s worth noting that voices in the wilderness, like Revere’s, have been calling for adjuvants and more efficient vaccine production for years.

If we’re smart, we’ll learn from this pandemic and be sufficiently prepared for the next one, which could be a helluva lot worse. (But are we that smart?) We need more than just vaccines, anyway; we need more critical care beds, more capacity to ramp up ERs, and additional public education on the usefulness of social distancing. We further need research on drugs that disrupt viral replication more efficiently than Tamiflu and its cousins, and on statin drugs (such as Lipitor) that might damp down the out-of-control immune reactions (aka cytokine storm) implicated in the deaths of vigorous young people when the pandemic virus is especially virulent. Revere suggested back in 2005 that the threat of highly virulent bird flu ought to spur research on statins. We’re still waiting for that research.

Just as we’re waiting for the proverbial other shoe to drop. My niece’s father out in California is now down with a fever and probable swine flu. (We worried about him once before, but this time he’s the daddy of a known “vector,” also known as my sweet niece.)

And as for me? Well, I’m the only person in my little family who’s not clearly in a risk group. I’m uneasy, because I don’t know if my Mystery Disease would put me at risk. I know I’ve got some wacky autoimmune stuff going on, along with some obvious neurological and metabolic misfiring – not to mention a long rap sheet for broichitis. But you can’t really march into a high-risk immunization clinic and announce, “Hey! I’ve got Mystery Disease! And my students all cough and sneeze on me! My young children wipe snot on me!” Um, no. That won’t get me very far. But it also won’t quell my qualms.

Wish me luck. I’ll be wishing the same for you, dear readers.

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