Re: Single Source For Most U.S. Vaccines
My Brother:
There seems to be some interest on this "conservative" thread for medical issues, especially as it relates to "trial lawyers."
Unless you are provoked, you seemingly post only on Iraq and foreign affairs.
The WSJ has an article that is found below dealing with the fact that of the many vaccines needed in the U.S., most are produced by a single manufacturer. Sometimes, as the chart below shows, there are two manufacturers, but this is down from 5 manufacturers for most of these vaccines 10 years ago.
Chiron, an American manufacturer based in San Francisco, had its flu vaccine plant in Great Britain.
The article suggests that one of the reasons for this reliance on a SINGLE manufacturer is that government IS now the single buyer of these vaccines. There also appears to be the concern that these manufacturers have about tort lawyers. In combination, the result SEEMS to be a dearth of companies who think it is worthwhile to make these vaccines.
I wonder if you could use your very fine intellect to address the issue?
Bruce
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Infectious Politics
October 14, 2004; Page A18
Americans are angry about the sudden shortage of flu vaccine, and well they should be. But we hope they don't fall for the current story line that this is all the fault of a single company and its British factory. The real problem lies with a political class that has driven all but a handful of companies out of the vaccine business.
Today there are only two significant makers of flu vaccine for the U.S. market, Aventis-Pasteur and Chiron Corp., which now finds itself besieged by federal subpoenas. The closing of Chiron's plant removes some 48 million vaccine doses (or about half the U.S. market) and puts that many more seniors and children at risk from a disease that kills 36,000 Americans a year.
Whether or not Chiron disclosed enough about its manufacturing woes is an issue of financial regulation. The main question for public health ought to be how did we arrive at a place where closing a single plant can endanger so many people?
SHOT IN THE DARK
Number of Vaccine Makers for U.S. Market, 2003
Hib1 3
Influenza 2
Hepatitis A 2
Hepatitis B 2
DTaP2 2
Measles, mumps, rubella 1
Tetanus 1
Tetanus-diphtheria 1
Polio 1
Chickenpox 1
Pneumococcal conjugate (children) 1
Pneumococcal polysaccharide (adults) 1
Meningococcal 1
Source: Centers for Disease Control
1 Haemophilus influenza type b
2 Diphtheria, tetanus, pertussis (whooping cough)
The answer is that any company brave, or foolish, enough to make vaccines has had to run an obstacle course of price controls, regulation and tort lawyers. Until Congress and federal officials come to grips with these fundamental problems, life-threatening vaccine shortages will continue to occur. (See the nearby table.)
Start with regulation. Health authorities understandably want vaccines to pass high safety hurdles, yet they've often gone overboard. A decade ago there were as many as five flu vaccine makers. But a wave of far tighter manufacturing regulations in the 1990s forced several makers out of business, even though it was never clear how these costly requirements would improve an industry with an already solid safety record.
Regulatory hurdles have also stifled innovation. It currently takes up to eight months to produce flu vaccine, which is grown with the help of special chicken eggs and is only good for one year. There are new techniques -- such as reverse genetics or mammalian tissue culture -- that promise to accelerate the process and make it less costly and ease shortages. "But regulators inside the FDA view these techniques nervously, and prefer the known," says Scott Gottlieb, a physician and a fellow at the American Enterprise Institute. In short, regulators instinctively believe risks outweigh benefits, and the approval process for new techniques remains difficult -- and costly.
Companies that decide to run these regulatory traps also know they will be doing so for very little reward. Before her big health-care reform crashed and burned in 1994, Hillary Rodham Clinton managed to get Congress to pass a government vaccine-buying program for children; her sales pitch was free vaccines for all kids and higher immunization rates. Thus the government now purchases about 60% of all pediatric vaccines, forcing huge discounts and imposing price caps. In 2001, the private-sector cost of immunizing children with the 20 recommended doses of vaccines was $600 per child. The government price was just $400 per child, with vaccine makers swallowing the difference.
What has this achieved? Vaccination rates for two-year-olds have stagnated at about 74% for the past several years, while adult rates are significantly lower. And with margins squeezed, some manufacturers have stopped making childhood vaccines. Flu-shot prices are also influenced by a federal and state buying presence (though not as big as in pediatric vaccines), and are set to worsen now that health authorities have added influenza to the Vaccines for Children program.
And who can write about health care without bringing up liability? Congress set up a program to protect vaccine makers from the tort lawyers who nearly bankrupted them in the 1980s, but the legal profession has already found loopholes. This is another reason for companies to invest their scarce human and capital resources in something other than vaccines.
We wrote about all of this back in 2002 when eight of 11 major childhood vaccines were in short supply, and Congress even passed a liability provision to help. But a trio of Republican Senators -- Olympia Snowe, Lincoln Chafee and Susan Collins -- held their leadership hostage and forced its repeal. Meanwhile, a program to stockpile childhood vaccines has stalled because the Securities and Exchange Commission and the Centers for Disease Control are fighting over how vaccine makers can account for the revenue of producing a stockpile. Maybe the SEC should settle this turf fight before flooding Chiron with legal demands.
There's no shortage of ideas for how to promote greater vaccine production, with many of the best ideas coming from the few manufacturers that remain. Now would be a good time to hear them out. As deadly as the flu is, consider the dangers of such infectious diseases as measles or whooping cough. Those are the next outbreaks to worry about if Washington keeps blaming everyone but itself for the vaccine crisis. |
