Vaccines: Learning as we go

Vaccine news has me thinking about a book I read a couple of months back, The Flaw of Averages: Why we Underestimate the Risk in the Face of Uncertainty, Sam L. Savage.

As the recent collapse on Wall Street shows, we are often ill-equipped to deal with uncertainty and risk. Yet every day we base our personal and business plans on uncertainties, whether they be next month’s sales, next year’s costs, or tomorrow’s stock price. In The Flaw of Averages, Sam Savage­known for his creative exposition of difficult subjects­ describes common avoidable mistakes in assessing risk in the face of uncertainty. Along the way, he shows why plans based on average assumptions are wrong, on average, in areas as diverse as healthcare, accounting, the War on Terror, and climate change.

The first article is from the New York Times:

A Nation Battling Flu, and Short Vaccine Supplies

[excerpts]

By ANDREW POLLACK and DONALD G. McNEIL Jr.

Dr. Anthony S. Fauci was talking with fellow federal officials in September, a month before swine flu vaccinations were to begin, when it became clear they had a bigger problem than they feared with supplies.

“As we got closer and closer, they said, ‘Oh, my God, we’re not going to make it,’ ”

Many of the projections originated from the Biomedical Advanced Research and Development Authority, or Barda, a part of Health and Human Services, which is responsible for vaccine contracting for emergencies. In April, an official with the agency predicted that as many as 600 million doses could be available by January, if all went well. From May through September, Barda signed contracts worth $1.5 billion for about 250 million doses of vaccine with five companies. The contract volumes were based basically on what each company said it could provide.
Dr. Fauci, the director of the National Institute of Allergy and Infectious Diseases, said in an interview.

Earlier this month, the government was forced to announce that only about 28 million doses would be available by the end of this month, about 30 percent below the 40 million it had previously predicted. That is not enough to satisfy panicky people who are lining up for vaccine around the country or desperately phoning their doctors and public health departments.

But the October shortfall was not the first. Indeed, since the outbreak of the H1N1 swine flu occurred in April, federal projections have been consistently and wildly overoptimistic and have had to be ratcheted down several times. As recently as late July, the government was predicting having 160 million doses by this month.
[snip]
But, these experts say, the government’s accomplishments, and its credibility, are being undermined by overly rosy projections that did not take account of the vagaries of vaccine production, making it look as if the vaccine effort is failing.

“To my mind, it was over-promising what there would be based on our historic experience with flu vaccines,” said Michael T. Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

“When you plant corn in May in Iowa, you have no idea what your harvest is going to be in October,” Dr. Osterholm said. “You have to factor in hailstorms, floods and whatever. They put out a very high yield estimate early on. Every time they had to back off, they lost credibility.”

An introductory scenario from Sam Savage’s book gives us an easily grasped glimpse into the likely flawed thinking that fed those estimates..

Imagine that you and your spouse have an invitation to a ritzy reception with a bunch of VIPs.  You must leave home by 6 p.m. or risk being late.  Although you work in different parts of town, each of your average commute times is 30 minutes.  So if you both depart work at 5:30, then you should have at least a 50/50 chance of leaving home together for the reception by 6 o’clock.

This thinking sounds right.  But your instinct warns that you will probably be late.  Which is correct: your brain or your gut?

Your gut is correct, but not being particularly good with words, it may have difficulty winning the argument intellectually.  So here, in terms that even a brain can understand, is why you’ll probably be late.

Suppose there really is a 50/50 chance that each of you will make it home by 6:00.  Then the trip is like a coin toss in which heads is equivalent to arriving by 6:00 and tails to arriving after 6:00.  Four things can happen:

  • Heads/tails: You are home by 6:00 but your spouse isn’t.
  • Tales/heads: Your spouse is home by 6:00 by you aren’t.
  • Tails/tails: Neither of you is home by 6:00.
  • Heads/heads: Both of you are home by 6:00.

The only way you can leave by 6:00 is if you flip two heads, for which there is only one chance in four.

Now imagine that your brother, who also works 30 minutes away, is going to join you. The chance of your all leaving on time now drops to one in eight.

Back to the New York Times article..

Federal officials say they factored such difficulties into their projections. They say they were pressed to make the projections by state and local health officials and by the news media.

I have it a lot lately, we botched our response to this pandemic — thankfully providence was kind and handed us one that was mild.  Though I sort of chuckled when I read that last line from the NYT.  “Don’t blame us — it’s YOUR fault!”  Ah, the Blame Game, it’s only human nature I suppose.

Still, they said, they relied on assurances from the vaccine manufacturers, some of whom might have been overconfident of their ability to resolve production problems.

“I think it’s fair to say that some were overly optimistic, thinking the fix was just around the corner,” said Dr. Nicole Lurie, the assistant secretary for preparedness and response at the Department of Health and Human Services.

Given how badly we botched the vaccine issue, and I must say – due to long known potential issues, though not specific to H1N1-2009,rather novel influenza strains in general, it is only natural to question other official assumptions.  When I started down that road I suddenly found myself asking exactly how much trust do we invest in our government and public officials anyway?  Not much was the answer I came up with, which explains why I also laughed when I read this bit…

But, these experts say, the government’s accomplishments, and its credibility, are being undermined by overly rosy projections that did not take account of the vagaries of vaccine production, making it look as if the vaccine effort is failing.

Two things: A) The vaccine effort IS failing, and B) We are learning as we go.  Mistakes will be made.  That too is only human nature.  As much as we would wish our public officials to be perfect – they are not – they are fallible human beings dealing with other fallible human beings, sometimes in the course of their duties a lot of fallible human beings in the course of the performance of their duties.

Let’s not get twisted up in the “Blame Game”, instead, let’s deal with the realities, and yes, the vagaries, of the situation we find ourselves in.

But more importantly, let’s learn from our mistakes so that next time — and there will be a next time at some point in the future — we will do better.  Doing better means less human misery [even if only temporary misery] and fewer very preventable deaths.  Preventable, that is, if one has access to a vaccine.

The stakes may be high but the learning curve is not all that steep.

Posted in H1N1 General, Vaccines | Tagged , , | 2 Comments

US vaccine supply

I am rather outspoken in my support of the pandemic H1N1-2009 vaccination campaign.  In the space of two weeks my son and then my husband have come down with [presumed] “Swine Flu”, and we had our first infection at my “day job”.

This week we also had a vaccination campaign at work.  Our seasonal vaccine was paid for by the corporation that employs me and the pandemic vaccine [FluMist] was paid for by the government.  I am pleased to say that our vaccine uptake at work was impressive.  Those that were eligible [no contraindications] to receive the FluMist vaccine opted to get it as well if they were getting their seasonal vaccine.

The vaccines can be difficult to come by, depending on which version one wants or needs:

Swine flu vaccines delayed, CDC says

Fri Oct 16, 2009 9:54pm EDT

By Maggie Fox, Health and Science Editor

WASHINGTON (Reuters) – Delivery of some swine flu vaccines has been delayed because companies cannot make it as fast as they had hoped, just as the virus has really started to spread, the U.S. Centers for Disease Control and Prevention said on Friday.

The CDC’s Dr. Anne Schuchat said that while 40 million doses had been anticipated for the end of October, only about 28 to 30 million doses would be available.

“Yields for vaccine are lower than would be hoped,” Schuchat said in a telephone briefing. “We unfortunately won’t have as much at the end of this month as we had hoped to.”

We have over 300 million people in the US. That’s a considerable shortage of vaccines.

She also said deaths from H1N1 swine flu were above the epidemic threshold in some U.S. cities and states. H1N1 flu activity was widespread in 41 states, she said.

It is unprecedented for this time of year to have the whole country having such high levels of activity,” Schuchat said.

An interesting “lesson” from this thankfully mild pandemic is that official assumptions have generally been that infections would “roll” across the country.

US Influenza 2009 Week 40

CDC : US Influenza 2009 Week 40

We now know that the “official assumption” is not supported by the reality of a highly infectious, even if mild, disease.

“There are now a total of 86 children under 18 who have died from the 2009 H1N1 influenza virus,” she added. Many had died in recent weeks and the number was now higher than the usual number of child deaths in an entire flu season.

These are very sobering statistics … 43 deaths in one month is a lot,” Schuchat said. “Some of these children have been totally healthy.”

Older children were hardest hit, she said, with 16 deaths among 5- to 11-year-olds and 19 deaths in 12- to 17-year-olds.

That would leave 8 deaths for children under 5.

I cannot help but remember the furor – and efforts expended – and costs incurred – when salmonella showed up in peanut butter.  Every peanut butter product was cleared from store shelves irrespective of whether they used the contaminated institutional product in their manufacture.  People cleared their pantries and cupboards of everything “peanut butter” in order to protect themselves [and their children] from the salmonella threat.

Not for the first time I find myself wondering why we can be outraged and driven to action [sometimes over reaction] when the perceived threat is caused by “the hand of man” yet many of us blithely ignore the potential assaults on our health from infectious disease – influenza specifically in this case.  Perception being “it’s only the flu” for many.  For most salmonella is no worse than a genuine case of influenza – yet look what we did in the face of that threat.  Mother nature just doesn’t inspire the same factor of outrage as human malfeasance.  Odd but true.

BUMPY DELIVERY

Schuchat said 15 percent to 20 percent of patients with H1N1 who needed to be hospitalized were requiring intensive care. “Influenza is widespread in the country and illnesses, hospitalizations and deaths continue to increase,” she said.

The U.S. government has opted to roll out seasonal flu vaccine and H1N1 vaccines as they become available, which the CDC has said could make for a bumpy vaccination plan.

People need both vaccines to be protected from all the circulating viruses, although Schuchat says virtually all cases of influenza are due to the new H1N1 virus.

I received my seasonal influenza vaccine on Thursday, paid for by my employer. The doctor’s office that was administering the seasonal vaccine was also administering the FluMist version of the pandemic strain vaccine, free of charge thanks to the government.

I turned 50 years old in April of this year and so I am a few months outside the official “2-49″ age range for FluMist.  I attempted to ask the nurse to administer the FluMist vaccine anyway, given I was only a few months outside the official guidance.  She very angrily responded that “It wasn’t safe!” to do so.  My counter was that if it would have been “safe” for me in March it was “safe” for me in October.

Needless to say, I was roundly denied the vaccine irrespective of “me as an individual”.  Not only was I flatly denied, the nurse reacted as if I had asked her to administer poison.  I very much wanted to tell the nurse that I was quite confident that I probably knew a great deal more about the vaccine than she but decided there really are times in life when fact and reality have no meaning outside an arbitrarily drawn line of demarcation.

Yes, the height of irony: I have spent two years expounding on the superiority of FluMist to the traditional injected vaccine, I have spent months exhorting the prudence of vaccination in the face of a pandemic, I… me… denied a vaccine because I am a few months too old.

Although I was angered by the arbitrariness of the “line of demarcation” and angered by someone obviously informed by nothing more than “orders”, I have no anger about being unvaccinated.  With only so many to go around some of us will just have to do without.  At least for the time being.

“This is how influenza vaccine production often goes,” Schuchat said. She said there should be widespread availability by November and advised people who wanted a vaccine but were having trouble finding one to keep trying.

Good advice. Advice I will surely follow. But as sound as the advice is, there will be an awful lot of us who will either become infected before we find a vaccine or this active phase of infection will pass and then we will lose the sense of urgency.  Influenza ain’t peanut butter.

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A temporary injuction

Nurses and doctors have won a victory in their battle for their “right” to infect patients with easily prevented pandemic influenza.

Judge Halts Flu Vaccine Mandate For Health Workers

[ Excerpt]
New York Health Care Employees Won’t Be Forced To Get H1N1 Vaccine…For Now
Health care workers in New York will no longer be forced to get the H1N1 swine flu vaccine, CBS 2 has learned.

A state Supreme Court judge issued a restraining order Friday against the state from enforcing the controversial mandatory vaccination.

The order came as the Public Employees Federation sued to reverse a policy requiring vaccination against the seasonal and swine flu viruses, arguing that state Health Commissioner Richard Daines overstepped his authority.

Three parties – the Public Employees Federaion, New York State United Teachers, and an attorney representing four Albany nurses – challenged the order and for now the vaccination for nurses, doctors, aides, and non-medical staff members who might be in a patient’s room will remain voluntary.

I can only hope that this is not only a temporary victory, but also very short lived.  I can hardly imagine being so selfish and self-centered, to say nothing of short-sighted.

Posted in H1N1 General, Healthcare During a Pandemic, Vaccines | 3 Comments