Is There a "Moron Flu Vaccine"?

If there is, then I think it should be administered to a few people.

USA Today: Desperately seeking flu vaccine? Get in line

"It's becoming the conventional wisdom that our (vaccine) infrastructure is quite flawed," says Martin Blaser, chair of medicine at New York University and president-elect of the Infectious Diseases Society of America. "Manufacturers have left the field because of various problems. We don't have a national policy to encourage development of vaccines."

Some experts say the shortage suggests that reliance on a free-market system to ensure basic public health safety may no longer be effective, and government may need to take on a greater role, as it has with regard to smallpox and other bioterrorism threats.

"This has taught us that the consequence of leaving it to market forces leaves the country as a whole without any rational distribution plan," says former New York City health commissioner Pascal Imperato, chief of preventive medicine and community health at State University of New York-Downstate in Brooklyn.

Do you know what came before and followed after this excerpt? All subsequent bolding is mine.

Nearly two weeks ago, vaccine maker Chiron said it could not supply up to 48 million doses of vaccine as promised from its plant in Liverpool, England, because British regulators had suspended its license. The Food and Drug Administration completed its own inquiry Friday and concluded none of the vaccine made there could be used.

So, right off the bat at the beginning of this article we get two examples of government intrusion into the economy, intervention that is in direct opposition to a free market.

"It's important to know why the FDA seems to have dropped the ball," says U.S. Rep. Henry Waxman, D-Calif., a member of the House Committee on Government Reform, which expects to receive FDA documents this week in an effort to unravel the timeline of events. "The British regulators conducted a full inspection of Chiron. The FDA took Chiron's word for it that everything was OK. I think the agency has become too close to the drug industry."

Acting FDA Commissioner Lester Crawford has strongly defended his agency's actions, saying it handled the Chiron situation by the book.

You've got the federal whip-crackers up in arms about how the system is run. Implicit acknowledgement that this is no "free market."

Under the current system, HMOs, hospitals, doctors, health departments and companies that run flu vaccine clinics place orders with distributors or directly with vaccine makers, usually by February or March. Because flu vaccine takes about six months to produce, relying on decades-old technology in which vaccine is grown in millions of chicken eggs, vaccine makers need that much lead time to know how much to produce. They generally make more than ordered as a cushion but never enough to supply the 185 million for whom annual flu shots are recommended — mainly the elderly, the infirm, health care workers and, as of this year, babies 6 months to 23 months old.

There has never been a need for that much vaccine. The most ever sold is just over 83 million doses last year.

[...]

Reports from the Institute of Medicine and GAO since the late 1990s have pointed out problems concerning vaccines: They're difficult and time-consuming to make; they require expensive technology to meet rigorous quality standards; they're subject to litigation from consumers who have bad reactions or who blame vaccines for problems such as autism; and they have relatively low margins of profit.

Flu vaccine, in particular, costs doctors less than $10 a dose. Whatever is unsold at the end of the flu season has to be dumped because the vaccine changes every year, as different flu viruses circulate around the world.

Not surprisingly, drug companies have gotten out of the vaccine business, seeking the greener pastures of blockbuster drugs to treat erectile dysfunction, diabetes or high cholesterol. Ten years ago, there were four companies making flu shots; today, there are two.

There is no telling how bad the coming flu season will be. Flu can be dangerous for the old and infirm - about 90% of the 36,000 who die of flu each year are elderly. But for most healthy people, it's "little more than a nuisance," Imperato says. Because of that, Americans tend to underestimate the disease's impact, and, until this year, shrug off advice to get a flu shot. In turn, manufacturers limit production, fearing they'll be left with millions of unused doses. In 2002, companies had to toss out roughly 12 million doses.

Two points:

1. Another statist intrusion endemic to all businesses, let alone the health care and medical industry, are government-imposed quality standards for all manner of goods and services. Thus the costs of doing business are increased above what players in a true free market would likely experience.
   
2. Anyone - and I mean anyone - who asserts that the state can come in and provide the "rationality" missing in this system is either ignorant of how people trade economically or is willfully blind.

Consider this. No one is more knowledgeable about my life and how I act than I am. And yet I would never attempt to detail what the next day in my life at any given time will be like. I might know the major goals I'll have for the day, what I plan on eating, and who I plan on meeting, but I'd be foolish to assert I know the intimate details of those three items and their associated chronology. Life simply has too many variables.

Extrapolate this difficulty to a business providing a service. You have to not only figure out what may happen to you but also to your customers, employees, stakeholders, and competitors. Additionally, in unfree markets, you also have to take into consideration the laws, regulations, and public statements of governments. This is a whole different realm of the unpredictable that has a significant on business operations.

Now take all this and add a few twists:

1. The driving force behind demand for a product of yours are the predictions of other people;
   
2. the target audience for your product is constantly changing and will prefer to be prioritized since this is a health issue;
   
3. and you have to rely on estimates of how a virus will spread throughout a deeply interconnected and travel-loving population

You are quite literally talking about a system that has input and output from nearly every American in the country and each of those inputs and outputs feeds back into the system, reinforcing some tendencies and undermining others. This is a forecasting job not even a weatherman would accept. No one human and no collective of humans is up to the task of effectively predicting what to do with what and when.

Which is one very important reason to keep these choices as decentralized and private as possible.

More examples of outright statism in the flu vaccine business:

Across the country, health departments are struggling to decide how to allocate limited supplies of vaccine. Most are complying with federal recommendations to vaccinate only those at highest risk of serious illness from flu, but there is not enough for everyone in the high-risk groups, and they're having to make difficult choices. Who should get vaccine first, an 85-year-old or a teenager with asthma? How can a doctor choose between a transplant recipient or a nurse who cares for AIDS patients?

Those questions haven't been answered. The Centers for Disease Control and Prevention is scrambling to figure out who has vaccine and where it's needed most, advising people to be patient as Aventis Pasteur, the sole surviving maker of flu shots for the USA, gets vaccine made and shipped out as fast as it can, at the rate of more than 2 million doses a week.

[...]

Several state health departments have declared an emergency so they can limit distribution to those in greatest need, and take action against distributors who are reportedly charging 10 times the usual price for vaccine.

© Copyright 2004 USA TODAY

That last one is especially important to note. It is the natural and necessary free market response to a situation of low supply and high demand. Anyone placing blame at the feet of unrestricted capitalism for the flu shortage isn't thinking.

And from the FDA's own chronology of the problem:

On August 25, 2004, as a result of performing routine testing required by FDA, Chiron identified bacterial contamination in a limited number of lots (approximately 4.5 million doses) of its influenza vaccine and notified FDA of the company's initial findings. At that time, Chiron quarantined all of its flu vaccine for this flu season (approximately 46 million doses) and was conducting an investigation into the cause of the contamination.

[...]

On October 15, FDA completed its investigation and presented its list of inspectional observations to Chiron's management as part of the close -out meeting that is held at the end of every FDA inspection. During that meeting, FDA investigators explained and discussed the observations that were documented during the inspection. FDA's inspection found significant deficiencies in quality control and concerns regarding the test results. Although Chiron's retesting of the unaffected lots of vaccine has been negative for contamination, FDA has determined that it cannot adequately assure the sterility of these lots to our safety standards.

What I assume this to mean is the ugly truth faced by this decidedly unfree market: there are more than 40 million doses of Chiron's vaccine that have tested negative for contamination but the FDA won't allow them to import these doses into the country for distribution. Therefore, all those people wasting their lives in lines for the vaccine should be pissed at the Food and Drug Administration for making the decision for them, without asking to do so.

I suppose that it's too much to ask mainstream reporters to accurately compare and contrast the statements they take from those they interview with reality. Anita Manning, the article's author, certainly did not.

Posted by Drizzten at October 18, 2004 05:00 PM