Posted on 10/16/2004 11:43:53 PM PDT by Cincinatus' Wife
Scene by disheartening scene, the spectacle of a severe shortage of flu vaccine is unfolding across the country.
Last week, elderly and chronically ill people waited in line for hours to get flu shots; some were turned away. One died after hitting her head when she passed out or fell while waiting. Price gougers demanded $800 for $60 vials of vaccine. States threatened to fine or jail doctors and nurses who gave shots to anyone not in the high-risk groups. Congress, the Justice Department and the Securities and Exchange Commission began investigations into how the nation has been left, on the brink of flu season, with half the flu vaccine it needs.
Experts gave warnings
The shortage caught many Americans by surprise, but it followed decades of warnings from health experts who said the nation's system for vaccine supply and distribution was growing increasingly fragile.
``We're in the middle of a crisis that could have been averted,'' said Dr. Irwin Redlener, associate dean of the Mailman School of Public Health at Columbia University and director of its national center for disaster preparedness.
Bill Pierce, a spokesman for Health and Human Services Secretary Tommy Thompson, acknowledged that vaccine supplies in the United States are vulnerable to supply disruptions. But he blamed years of neglect by previous administrations. Thompson has made fixing the system a priority, Pierce said.
The administration has increased financing for handling the flu, including considerably more money for research into more reliable manufacturing techniques for vaccines, he said.
In particular, public health experts have long cautioned against the country's dependence on a few vaccine makers, and yet this has become standard practice. There are now only two major manufacturers for the nation's supply of flu vaccine, and at least a half-dozen other vaccines are made by single suppliers. Britain, by contrast, has spread its order for flu vaccines among five suppliers, precisely to avoid the kind of predicament America now faces.
Many disruptions
In recent years, there have been many significant disruptions of vaccine supplies. Between November 2000 and May 2003, there were shortages of eight of the 11 vaccines for childhood diseases in the United States. There have been flu vaccine shortages or miscues for four consecutive years.
In recent decades, many drug companies in the United States abandoned the manufacture of vaccines, saying that they were expensive to make, underpriced and not sufficiently profitable. Flu vaccine can be a particular gamble, because the demand for it varies from year to year and companies must throw away what they do not sell because a new vaccine must be made each year to deal with changing strains of the virus.
Some companies dropped out because of lawsuits, and others because they determined that it would not pay to retool aging vaccine plants to meet regulatory standards.
The government did little to stop companies from quitting the business, and in some cases may have created policies that made matters worse. A report last year by the Institute of Medicine, a unit of the National Academy of Sciences, noted that 30 years ago, 25 companies made vaccines for the United States, whereas today there are five.
Having few suppliers a risk
Dr. Jesse Goodman, director of the branch of the Food and Drug Administration that oversees vaccines, acknowledged that it was risky to have only one or two suppliers for products so essential for public health.
The heart of the problem, experts say, may be that no one person or agency is truly in charge of making sure that the United States has an adequate vaccine supply.
FY2004 Budget and Vaccines - President Bush released his FY2004 Budget Proposal in early February 2003. The President’s proposal would expand the Vaccines for Children (VFC) program in three ways:
1. The first goal is to improve vaccine access for underinsured children at state and public health clinics. Currently, underinsured children are only eligible to receive VFC vaccine at federally qualified health centers. Under the new plan underinsured children would be eligible to receive vaccine through the VFC program at state and local public health clinics. ("Underinsured" is defined as no coverage for immunization. Children with health insurance with high deductibles or co-pays are not considered underinsured under this proposal.)
Further comments from CDC/NIP officials on the expansion proposal:
No anticipated change in public and/or private market share. Underinsured children are currently being served by public funds through Section 317 vaccine purchasing program. They will still be covered by public funds under the President’s proposal but now via the VFC program. Designed to take pressure off Section 317 vaccine purchases and state funds to cover immunizations for underinsured children. Many states do not have funding from Section 317 to provide PCV-7 in public clinics. As more new vaccines enter the market, lack of sufficient 317 funding will become a growing problem to provide vaccines in public health clinics. The shift to the VFC program for purchase of these vaccines, however, will alleviate this cost burden from the Section 317 vaccine purchasing program and ensure that funding is provided.
2. The second goal of the President is to reinstate Td and DT to the VFC program by removing price caps. Currently, price caps exist on vaccines that were in the program at its formation: MMR, Hib, IPV, Td and DT. Rather than submit to the VFC price cap for Td and DT, the manufacturer of these vaccines refused to enter into a VFC contract and these vaccines have not been part of VFC for several years. This proposal would lift all the price caps in the program with the intent of bringing Td and DT back onto the federal contract and into the VFC program.
The proposal would:
Lift price caps on all vaccines including MMR, Hib, IPV and Td/DT
Provide incentives to manufacturer to bid on contracts
Cost an estimated $10M (to be shifted from 317 to VFC)
Possibly increase cost of other vaccines, but MMR is currently the only vaccine selling at capped price, others sell below cap
Take pressure off the states to negotiate and purchase Td/DT in the open market
3. The third goal is to build a six-month national stockpile of childhood vaccines should an emergency or vaccine shortage problem occur. A strategic plan for building the stockpile would be developed by CDC in conjunction with its immunization partners.
The President's stockpile plan acknowledges the authority under the VFC program to stockpile vaccine for all children (not just VFC eligible children). The estimated time for the stockpile to be ready is 2006.
Estimated costs for stockpiling for FY2003-FY2006 totals $707M ($172M for FY2003).
*It is important to note that expanding VFC to cover underinsured children in additional settings and lifting the price caps will require legislation contingent upon Congress's approval. According to CDC, if Congress does not pass such legislation, the President's budget proposal for Section 317 vaccine purchase will remain at the current level.
In conjunction with the proposal to expand VFC to cover underinsured children, the President’s budget includes a shift in vaccine purchase funding from Section 317 to VFC. This shift of $110M to the VFC program from Section 317 in FY2004 will go into effect only if Congress passes the VFC expansion, according to Dr. Walter Orenstein, Director of NIP. Also, according to Dr. Orenstein there will be a $7M decrease in the overall Section 317 budget, which will be taken from IT (information technology) at the National Immunization Program.
The budget for Section 317 operations/infrastructure remains level in the President’s budget proposal at $201M, of which $189.5M reported by CDC will be granted to States. The $189.5M figure is below the Institute of Medicine’s recommendation of $200M in grants to states.
**An additional note: VFC contains an additional $40M for the catch-up pneumococcal vaccine but no funding has been allotted for the new combination vaccine thus far.
Seems to me that it's time to examine this situation as a potential bio-attack, and not just an opportunity for political posturing.
Is not the influenza vaccine a matter of homeland security?
Whether sabotage or not, the effect is the same, right?
We are at war. We are not getting the 'rest of the story.' And this kind of reported 'contamination' did not seem to occur years ago.
I don't think that we can accept this vaccine shortage again next year, when each dose is inexpensive and we are willing to pay out of pocket.
Thanks for this. Bump.
I hadn't thought of that.
Nothing is out of the question.
Kerry/Edwards have the gall to try and pin this on the Bush Administration.
What next?
All Kerry/Edwards have is a campaign of lies and hate.
Yes, though with Medicaid and local programs (e.g., for illegals), we have a form of general health care which improves the more you can pay. Like any profession, Medicine has its rewards and baseline costs. Could you imagine universal legal services, or a universal government haircut plan?
Or government insurance on our home and car.
Lawsuit abuse and price caps are slowly strangling health care and driving up costs.
You can't sue a foreign vacine maker I think. I know that was the reason years ago when my daughter needed DPT shot they were short. Many companies refused to make it because the main one was sued to death. I could be wrong but I believe you can't sue in Canada because the docs are gubmint workers.
Government health care is not American.
Amen, and ahmein... I think I have finally accumulated enough links on the flu vaccine "crisis" to do a post of links.
Do you recall that old joke that was popular in Russia when she was the Soviet Union?
Q. What happens when the USSR takes over the Sahara Desert?
A. For fifty years... nothing.
Then there's a shortage of sand...
That's right!!
ping
Am I out of the loop here, or what? How come nobody's mentioned Hitlery's part in this mess? She and Bubba pushed to get a bill that said the government would buy flu vaccine "for the children." They capped the price to the point where labs in this country closed down because they weren't making enough to fight off law suits.
Hillary and Edwards. Bad for America. Bad for the children. Bad for everyone.
***Then there's a shortage of sand...***
Bears repeating.
I just got this up, and Hillarrhea! is included:
The boards of US drug companies do not go into meetings one day and randomly decide to stop production of a particular drug or vaccine. They carefully weigh the the risks and potential profit, like any other business, of what to produce and not to produce.
So, imagine, prior to the current shortage if President Bush, or any other Rep. leader suggested that drug companies have no incentive to produce the flu vaccine; that this was a risk to US health and security and as a result he was proposing massive tax incentives and/or subsidies to support the domestic production of flu vaccine.
The Dems would have gone ape. They would have called it welfare for greedy drug companies and/or payoff for support of Bush's feed the rich tax program. The Dems would have said the US can get all the vaccine she needs overseas at market prices so their is no need to pay US producers to make it.
Or, imagine if Bush, or some other GOP leader, proposed reducing liability to manufacturers for flu vaccine, as in incentive to restart production. The Dems would have had a fit, and line up to protect their trial lawyer constituents. They'd roll out the biggest tragedies they could think up. They'd claim Bush is just trying to protect his fat cat greedy drug company friends.
And most of the media would play right along with the Dems. There is no way Bush could win. But now, now that there is a shortage they want to say Bush should have done something; that its all Bush's fault. But few ever consider that it's hard to pass meaningful legislation when demagogues are guarding the Senate floor.
How about "The government did little to encourage companies to stay in the vaccine business".
Maybe I'm reading too much into it, but the statement from the article seems the height of ignorance, in a free society. You can't make someone do, what they don't want to do, and cannot make money at.
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