The Flu Shot Crisis and how to fix it...

The flu shot crisis is old news by now(Vaccine shortage a global crisis), but to my knowledge no one has come up with a solution other than "let's wait and see what happens next year". Hmmmm. That being said the WHO (not Roger Daltry and company the World Health Organization) is warning of a pandemic that can be expected to take at least seven million lives (CNN.com - WHO warns of dire flu pandemic - Nov 29, 2004). Double hmmmm. Am I the only in this country that thinks sitting around waiting for the entire species to take it on the chin is not the most prudent course of action?

I've sent a letter to Senators Lieberman, Dodd and CT Governor Jodi Rell (I'll post it at the end of this blog) outlining some of the crucial first steps to mitigate this pending epidemic and how to eliminate flu shot fiascos in the future.

First off a little perspective...

Unless you live in a cave (and even then) you're probably aware that this country has declared war on terrorism. Toward that end we've spent or are going to spend 300 billion dollars over a four-year period. We lost around 3,000 lives on 9/11.

We lose on average of 30,000 lives a year to the flu. That's 120,000 lives over a four year period.

In the last pandemic (The 1918 Influenza Pandemic) estimates range as high as 20 million dead by the Spanish flu (don't blame the Spanards they got whacked too). More people died from the flu than by the human folly of WWI.

Got perspective? Still want to wait around until next year and see what happens? Want to leave human destiny in the hands of a foreign corporation (Chiron, Chiron Corporation) whose primary motivation is profits?

So... how do we prevent this Flu Shot Crisis from happening again? To quote Lead Zeppelin... "Bring it on home".

If we can spend 300 billion to prosecute a war on terrorism, 100 of that in Iraq, then it seems to me we can spend say %10 of that figure combating the flu. For a four-year period that means we'd be spending one-tenth the amount of money saving 40 times as many lives. Of course I'm over simplifying because you're not going save every life with a flu shot, but I think you get the point.

First off we need to understand why we're not producing the flu shot here in the U.S. in the first place. That's easy... profits. What else? It seems that American Pharmaceutical companies can only produce drugs that are expensive.

That being said I'd like to express what I believe is a fundamental truth: if there is a critical need (Is Asian Bird Flu the Next Pandemic?) required by the American people that can not be supplied by private industry than it is the ultimate duty of the American Government to fulfill that need (ie., Social Security, Defense, environment protection, etc.).

OK, enough exposition. Here are the firs two steps on how we fix it.

1) The U.S. government should create a not for profit, semiprivate corporation whose charter will be to manufacture flu vaccine for distribution to the American people. The rational for making it a semiprivate corporation is an attempt to build a self-funding organization that is run outside of the purview of politicians. The American people don't need another boondoggle.

This new corporation will contract to build at least four flu shot vaccination manufacturing plants throughout the country (Northeast, Southeast, Midwest and Western).

It should be noted these plants need to be built yesterday so the government should come up with some kind of competition among the various pharmaceutical companies to build that highest quality, least expensive plants in the shortest amount of time. Maybe the winner gets a tax holiday for five years or a patent extension on the drug of their choice for ten years.

Each plant will have the capacity to provide every American with a flu shot. That way you could still shutdown three plants and provide the entire country with vaccine.

Each plants location will be chosen for proximity to railways, airports and highways for the most efficient transport throughout the country.

Excess capacity can be sold to the rest of the world to offset costs.

(Flu pandemic could kill one billion people around the world, say ...)

It should also be noted that besides savings thousand of American lives every year you'd also be providing hundreds, if not thousands of good paying jobs to American citizens.

2) The government needs to sponsor something comparable to the X-Prize (10 million dollars to the first private, reusable spacecraft developer, ANSARI X PRIZE) to shrink the time to manufacture of flu vaccine. Right now it takes around 11 days to produce vaccine and a 6-month total time from creation to distribution! This is far to long in the event of a full-scale outbreak never mind a pandemic. Remember this is just manufacture time. You still need to come up with a vaccine and in the case of a new strain this could take months.


These are my ideas on how to fix the flu shot crisis. They will not in and of themselves prevent a worldwide pandemic, but if a vaccine is discovered early during the next outbreak these steps will keep the body count down. I have some ideas on how we should be preparing for the next pandemic (WHO Meeting Warns of Flu Pandemic (washingtonpost.com)) and I will expound upon them at a later date.

If you agree with my observations please write/email your senator and or congressman and reference this blog. Unfortunately congress is too preoccupied with terrorism to address issues of equal if not deadlier import.

If you don't agree with my observations then please come up with some ideas of your own and raise the issue up. Even if we don't agree on the methods I'm sure we agree there's an accident waiting to happen.

Respectfully Submitted,

A. A. Roberts


P.S.

Here is the original note I sent to Senators Lieberman, Dodd and Governer Rell and the reponse I got back from Senator Lieberman:

The Letter

Dear Senator,

How’s it going? Too bad about the election, but we shall overcome. At the depths of adversity we shall find the strength to lead us to the heights of prosperity… or something like that.

Anyway I thought I’d share and idea with you whose time has come. I know you’re well aware of the flu shot situation. Once again we have outsourced the manufacture of yet another product in the name of profits. Evidently only the English can make flu shots profitable, well, that is when they make a good batch. We all know what happened there.

This country hires a few hundred thousand military personal and hundreds of billions of dollars to protect American lives from the forces of evil. We lost around 3,000 at the start of the war on terrorism as you well know.

Over 30,000 people a year(!) die of the flu. Why are we not investing a few measly billion dollars in building a federally owned, run, managed, flu-shot manufacturing facility IN THE US!? The undeniable and catastrophic loss by a flu pandemic far and away exceeds any threat by terrorists. More lives were lost to the flu pandemic of 1918 then WWWI.

I know people like smaller government. So do I, but there are some things that the government needs to do and I believe this is one of them.

I’d like to leave you with this thought. How happy do you think your constituents would be if you proposed this idea and had the Northeast manufacturing plant built in Connecticut? How happy do you think the American people would be to know that your helping to safe THOUSANDS of lives EVERY YEAR.

You do this and you da Man!

Respectfully submitted,

A.A.Roberts


The Response:


Mr. Roberts:

Thank you for contacting me regarding your concerns about this year's fluseason and the 2004-2005 influenza vaccine shortage. I share yourconcerns.

As you may know, almost half of the nation's flu vaccine will not bedelivered this year. On October 5, 2004, the Centers for Disease Controland Prevention (CDC) was notified by Chiron Corporation, a majormanufacturer of flu vaccine, that none of its influenza vaccine (Fluvirin)would be available for distribution in the United States this flu season.Chiron was to make 46-48 million doses of vaccine available for the U.S.However, the company indicated that the Medicines and Healthcare ProductsRegulatory Agency (MHRA) in the United Kingdom, where Chiron's Fluvirinvaccine is produced, has suspended its license to manufacture Fluvirinvaccine in its Liverpool facility for three months, thus preventing anyrelease of this vaccine for this influenza season.

Chiron's announcement of its manufacturing failure took us all bysurprise and has presented a potential public health crisis, exacerbatedby unequal distribution of remaining vaccine and natural human tendenciesof fear. Some 36,000 Americans die each year from influenza-relatedcomplications; and the vast majority of them are seniors.

The remaining supply for influenza vaccine expected to be available inthe U.S. this season is nearly 54 million doses of Fluzone (inactivatedflu shot) manufactured by Aventis Pasteur, Inc. As of October 5,approximately 33 million of these doses had already been distributed bythe manufacturer. The remaining 21 million doses will be releasedgradually - approximately three million per week for seven weeks. This isin order to assure that the distribution is compatible with the prioritydistribution plan created by CDC and in cooperation with state and localhealth departments. Aventis Pasteur now promises to manufacture anadditional 2.6 million doses that will be available in January 2005. OnOctober 21, MedImmune announced it would be increasing its production tothree million doses of FluMist (a vaccine made with live, weakened fluviruses that do not cause the flu).

Because of this urgent shortage of vaccine, CDC, in coordination with itsAdvisory Committee for Immunization Practices (ACIP), is changing itsguidance about who should get vaccinated this season. These newrecommendations take precedence over earlier recommendations and call onstates to limit vaccines to vulnerable populations only.

According to CDC guidelines, the existing flu vaccine supplies should begiven to protect people who are at greatest risk from seriouscomplications from influenza disease. Therefore, everyone in thefollowing group should seek vaccination:

. People 65 years of age and older;.
. Children ages 6 months to 23 months;
. Adults and children 2 years of age and older with chronic lung or heartdisorders, including heart disease and asthma;
. Pregnant women;. Adults and children 2 years of age and older with chronic metabolicdiseases (including diabetes), kidney diseases, blood disorders (such assickle cell anemia), or weakened immune systems, including persons withHIV/AIDS;
. Children and teenagers, 6 months to 18 years of age, who take aspirindaily;. Residents of nursing homes and other chronic care facilities;
. Household members and out-of-home caregivers of infants under the age of6 months (children under the age of 6 months cannot be vaccinated);
and. Health care workers who provide direct, hands-on care to patients.

Healthy people 2 to 64 years of age are asked to forego vaccination thisyear or wait to get their vaccine until after persons in priority groupsin their area have had a chance to be vaccinated. Available vaccine can,therefore, go to protect those at greater risk for flu complications.

According to CDC, FluMist (the nasal-spray flu vaccine) is a safe optionfor healthy individuals, ages 5 to 49 years of age, who are in contactwith infants under 6 months of age or who are health care workers whoprovide direct patient care. FluMist is not recommended for health careworkers taking care of severely immuno-compromised people when they are ina protective environment, and it cannot be given to pregnant women.

CDC further indicates that certain good health habits can help preventthe spread of flu. These include:

. Avoid close contact with people who are sick. When you are sick, keepyour distance from others to protect them from getting sick, too.
. Cover your nose and mouth with a tissue when you cough or sneeze - anddispose of the tissue afterward.. If you do not have a tissue, cough or sneeze into your sleeve.
. Wash your hands after you cough or sneeze - with soap and warm water orwith an alcohol-based hand cleaner.
. If you get the flu, stay home from work or school. You will helpprevent others from catching your illness.

Finally, CDC suggests that for individuals in high-risk groups whoselocal clinic has no vaccine, they should contact their local healthdepartment and ask their regular vaccine provider about other options forinfluenza vaccination.

I understand that health departments throughout the U.S. are trying tomake certain that as many high-risk people as possible are able to getvaccine from their regular vaccine provider or a flu shot clinic. Somepublic vaccination clinics may also be posted at http://www.lungusa.org/.

During the previous flu vaccine shortage in December 2003, as RankingMember of the Governmental Affairs Committee, I asked the nation's tophealth official, U.S. Health and Human Services (HHS) Secretary TommyThompson, to assess our vulnerabilities and to find remedies for a severeflu outbreak spreading across the country. In a letter to SecretaryThompson, I sought clarification on how HHS was coordinating thegovernment's efforts to address that crisis; and I warned that theresponse to the flu outbreak reminds us of our vulnerabilities in theevent of a bioterror or unintentional infectious disease outbreak. Lastyear's flu outbreak was more virulent than expected, and the limitedamount of vaccine that was administered provided only partial protectionagainst the main strain of influenza infecting people at that time.

This year, I remain deeply concerned about the current national influenzashortage and have again written to HHS Secretary Thompson to encourage hisagency's efforts to procure more vaccine from international sources, aswell as to work with CDC in enforcing its priority list for high-riskpeople.

Finally, given the announcement regarding the flu vaccine shortage forthis season, I testified on October 6 before the Senate Judiciary andHealth, Education, Labor, and Pensions Committees about the need to expandProject BioShield, which I helped draft and which President Bush signedinto law on July 21, 2004, to help ensure an adequate medical defenseagainst bioterror attacks. Senator Orrin Hatch (R-UT) and I plan tointroduce a BioShield II bill in the early weeks of the 109th Congress,which aims to resurrect a U.S. vaccine industry as part of a newbiodefense industry. Our plan would include major incentives to enhanceU.S. biologics manufacturing capacity so we can produce more vaccines.

My staff and I are conscientiously monitoring the flu vaccine shortage inConnecticut. Please be assured that I will continue to work with mycolleagues in Congress and with CDC and the U.S. Food and DrugAdministration on greatly needed efforts to establish a protocol toattempt to prevent, prepare for, and respond to an influenza epidemic orpandemic. We need to ensure that those who are most vulnerable areprotected first, while, at the same time, taking critical steps to ensurethat far-reaching reforms are enacted to prevent future vaccine shortages.For the latest update about what is being done to address these shortages,please visit my web site at http://lieberman.senate.gov/ where you canaccess the latest information about this year's flu season, which isspotlighted at the bottom of my home page.

My official Senate web site is designed to be an on-line office thatprovides access to constituent services, Connecticut-specific information,and an abundance of information about what I am working on in the Senateon behalf of Connecticut and the nation. I am also pleased to let youknow that I have launched an email news update service through my website. You can sign up for that service by visitinghttp://lieberman.senate.gov/ and clicking on the "Subscribe Email NewsUpdates" button at the bottom of the home page. I hope these areinformative and useful.

Thank you again for letting me know your views and concerns. Pleasecontact me if you have any additional questions or comments about our workin Congress.

Sincerely,Joe Lieberman

JIL:vdh