EUGENE – Doctor and former Oregon Governor John Kitzhaber joined Oregon seniors Thursday to call attention to George W. Bush’s inattention to America’s pressing health care issues over the last four years – the results of which are now seen with the flu crisis across the nation and in Oregon.
Three years ago, medical experts warned George Bush that a dangerous flu shot shortage loomed. Instead of fixing the problem, production of the vaccine was sent to a factory overseas – and the vaccines were contaminated. Now Bush wants Canada to help, even though his own policies make it illegal for us to import medicine from Canada.
On October 20, the Associated Press described Oregon as having the “worst vaccine shortage in 10 years.” A former emergency room doctor and architect of the Oregon Health Plan, Kitzhaber is an especially knowledgeable source on the pressing issue of health care.
“The flu happens every year. It’s not a surprise,” said Kitzhaber. “There’s just no excuse to have a shortage of vaccine. The GAO said in 2001 that we were vulnerable for this situation. This is just the latest symptom of an administration that has continually ignored domestic policy’s number one issue-health care. With emergency rooms already overwhelmed, a flu epidemic will send hospitals over the edge.”
The flu causes approximately 36,000 deaths and more than 100,000 hospitalizations ever year.
Less than 25% of those Oregonians most at risk will get the vaccinations they need, due to Bush’s ignoring of this problem. The AP reported that “Oregonians who fall into the high-risk category, will not get the flu vaccinations that they need. Officials estimate that 1 million Oregonians fall into the high-risk category, which includes the elderly, the sick and the very young…A statewide assessment shows that Oregon will have at most 250,000 vaccines this season.”
Kathy Hahn, a Eugene pharmacist said, “Nobody knows what to do. We’re not sure what to tell people. It’s stressful to wait in a long line and the majority of my patients won’t be able to do that.”
Vice President Dick Cheney, Secretary of the Treasury John Snow and Republican Senator Bill Frist have all gotten flu shots as Oregon seniors and children get left behind.
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About 36,000 Americans Die from Flu Each Year. “Every year in the United States, on average: 5% to 20% of the population gets the flu; more than 200,000 people are hospitalized from flu complications; and approximately 36,000 people die from flu.” [Centers for Disease Control and Prevention, “Fact Sheet: What Everyone Should Know About Flu and the Flu Vaccine,” 10/6/04, www.cdc.gov]
Up to 180 Million Americans Could Benefit from a Flu Shot . “Last year, [CDC Director Julie] Gerberding said, about 83 million doses of the vaccine were used out of a stockpile of 87 million doses. Under normal conditions, as many as 180 million Americans could benefit from a flu shot, she said.” [Washington Post, 10/13/04]
Vaccination Cuts Flu-Related Deaths by 70-80% Among Seniors. “Vaccination is the principal measure for preventing influenza and reducing the impact of epidemics. … Among the elderly, vaccination is thought to reduce influenza-related morbidity by 60% and influenza-related mortality by 70-80%. Among healthy adults the vaccine is very effective (70-90%) in terms of reducing influenza morbidity, and vaccination has been shown to have substantial health-related and economic benefits in this age group.” [World Health Organization, “Influenza: Overview,” Fact Sheet No. 211, Revised March 2003, www.who.int]
Three years ago, medical experts warned George Bush that a dangerous shortage loomed.
· GAO: “No System to Ensure that High Risk People Have Priority When the Supply of Vaccine is Short.” “Currently, there is no system to ensure that high-risk people have priority when the supply of vaccine is short. In a typical year, enough vaccine is available in the fall to meet total demand, both from high-risk individuals and from others who simply want to avoid the flu. When the supply became short in the fall of 2000, however, there was no mechanism to target vaccine to those who needed it most.” [General Accounting Office, “Flu Vaccine: Supply Problems Heighten Need to Ensure Access for High-Risk People,” GAO-01-624, 5/15/01, p. 3, www.gao.gov]
· GAO: Shortfall by Even One Manufacturer “Can Significantly Impact Overall Vaccine Availability”. “The circumstances that led to the delay and early shortage of flu vaccine during the 2000-01 flu season could repeat themselves in the future. Ensuring an adequate and timely supply of vaccine, already a difficult task given the current manufacturing process, has become even more difficult as the number of manufacturers has decreased. Now, a production delay or shortfall experienced by even one of the three remaining manufacturers can significantly impact overall vaccine availability. … In the event of a future delay or shortage, determining the most effective means of changing this traditional behavior will be beneficial.” [General Accounting Office, “Flu Vaccine: Supply Problems Heighten Need to Ensure Access for High-Risk People,” GAO-01-624, 5/15/01, p. 22, www.gao.gov]
Instead of fixing the problem, production of the vaccine was sent to a factory overseas – the vaccines were contaminated.
· Contaminated Vaccines Discovered at U.S. Vaccine-Maker’s British Plant. “The supply of influenza vaccine for the coming winter was abruptly cut in half yesterday when one of only two companies making flu shots for use in the United States said it would not be able to sell 48 million doses here because some of it may be contaminated. … Chiron Corp., which makes flu vaccine at a plant in Liverpool, England, said in August it would deliver most of its product about a month late because some lots had been found to be contaminated with bacteria. Yesterday, however, virtually the entire order was canceled after the British agency that regulates drug manufacturing decided over the weekend to halt all vaccine shipments from the plant for three months while it investigates.” [Washington Post, 10/6/04]
Now Bush wants Canada to help, even though his own policies make it illegal for us to import medicine from Canada.
· Bush: “We’re Working with Canada”. “We’re working with Canada to hopefully — that they’ll produce a — help us realize the vaccine necessary to make sure our citizens have got flu vaccinations during this upcoming season.” [Bush remarks, Third Presidential Debate (Tempe, Arizona), 10/13/04]
· Bush’s Own Health Secretary Said “Doubtful” Vaccines from Canada Would Be Approved in Time. “America’s top health official and other experts said Thursday that getting more supplies of vaccine from Canada is unlikely. There isn’t enough time for U.S. regulators to approve a Canadian vaccine, and Canada doesn’t have enough to spare, they said. … Health and Human Services Secretary Tommy Thompson told reporters that it was “doubtful” that a Canadian flu vaccine — or a German one — could get Food and Drug Administration approval in time for this influenza season.” [Orlando Sentinel, 10/15/04]
Bush Administration Own Policy Prohibits Americans from Importing Low-Cost Drugs from Canada.
· In a Statement of Administration Principals issued by the White House Office of Management and Budget on July 23, 2003, Bush stated his strong opposition to drug re-importation. The SAP states, “H.R. 2427 [to allow the re-importation of prescription drugs] is dangerous legislation. It would expose Americans to greater potential risk of harm from unsafe or ineffective drugs, would be extremely costly to implement, and would overwhelm FDA’s already heavily burdened regulatory system.” [Office of Management and Budget, SAP on HR 2472, 7/23/03, www.whitehouse.gov/omb]
John Kerry’s Plan to Address the FLU VACCINE Crisis
As president, John Kerry will ensure that there are sufficient vaccine supplies to protect the American people from a major flu outbreak. To protect America’s health, John Kerry will develop a private and public strategy to prevent a crisis like the one we are experiencing today. He will strengthen the nation’s ability to develop, produce, and distribute safe flu vaccines by putting America’s ingenuity to work. As president, Kerry will:
ADDRESS THE CURRENT SHORTAGE
Crack down on price gouging. During this shortage, a small minority of unscrupulous vendors are exploiting the current crisis by raising the price of vaccines by 50, 100 or even 200 percent, meaning that only the wealthy can afford protection. The Bush administration approach – simply collecting information on the practice and sending it to state law enforcement officers – is completely inadequate. John Kerry believes the administration must take forceful steps to end the deplorable price gouging of this essential national resource. Vaccine vendors doing business with the federal government should be required to disclose changes in pricing, and the Department of Justice and the Federal Trade Commission must coordinate with Department of Health and Human Services (HHS) in scrutinizing and prosecuting predatory pricing, price gouging, and other unfair trade practices.
Require reporting of vaccine supplies. In the event of a shortage, public health officials at the federal, state, and local levels should immediately have access to information about exactly who has the flu vaccine and how much. The Bush administration has relied on voluntary disclosure from the remaining manufacturer of the flu vaccine, forcing health departments to contact thousands of health providers in a desperate search for supplies. This disclosure should be mandatory for all vaccine distributors and vendors, and the administration should collect and coordinate data on vaccine availability in an emergency operations center so that local public health officials can make decisions on reallocation quickly.
Encourage voluntary donation of vaccines. Many companies purchased vaccines for their employees, some of whom are not at high risk of infection. With the current vaccine shortage, many of these companies now wish to donate their excess vaccine doses, provided they go to individuals in need. The administration should make the strongest public appeal for cooperation by health care and retail entities to work with HHS, states, and local communities to set up and divert supplies to emergency clearinghouses to allow donation of vaccines to those in greatest medical need.
Establish a vaccine buy-back program. HHS should immediately be given resources from the Public Health Emergency Fund to buy back – at a fair price – vaccine doses from those who do not wish to donate them to clearinghouses in case of a flu emergency.
Increase the national stockpile of anti-viral medications. For those sick with flu, anti-viral medications can mean the difference between life or death. The government should immediately increase the federal stockpile of these medications so they can be deployed in a flu emergency.
PREVENT VACCINE SHORTFALLS FOR THE FUTURE
Establish a strategic reserve of flu vaccine. Currently, the amount of vaccines produced to protect Americans from flu are based on a guess by vaccine manufacturers about how severe the upcoming flu season will be. If their guess is wrong, the American public pays the price. Kerry will work with manufacturers to eliminate the guesswork of estimating future vaccine demand and will ensure an adequate supply of flu vaccine every year. The government will guarantee purchases of unused vaccines at the end of the flu season to help prepare for the possibility of sudden shortages. Establishing a strategic vaccine reserve will protect the public health even if demand for vaccine is higher than expected or there are unanticipated shortages.
Strengthen no-fault Vaccine Injury Compensation Program. John Kerry supports the National Vaccine Injury Compensation Program, a no-fault liability system established to ensure an adequate supply of vaccines, stabilize vaccine costs, and maintain an accessible, equitable, and efficient forum for individuals thought to be injured by childhood vaccines. He will act immediately to include in the VIC program all claims against manufacturers and providers of flu vaccines for adults as well as children. Also, Kerry will strengthen this program by increasing the number of judges who hear the cases and by ensuring that HHS has adequate funding to administer the program more efficiently.
Encourage multiple manufacturers to produce flu vaccine. Today, virtually all flu vaccine is produced by just two manufacturers. The Kerry administration will work with the biotechnology industry, including generic companies, to increase the number of manufacturers who provide our country flu vaccines. He will make sure that there is sufficient production capacity among a range of companies by providing responsible incentives to enter the marketplace, such as guaranteed contracts to purchase vaccine. And he will work with states to explore economic development incentives to attract more flu vaccine manufacturers into the market.
Work with manufacturers to ensure safe, adequate vaccine supplies. The flu vaccine is a critical national resource. Assuring its safety should have been one of HHS’ top priorities, but the Bush administration fell asleep at the switch when warning signs of contamination problems arose in June 2003. Beyond simply playing a regulatory role, the FDA must be empowered to ensure that public health concerns are addressed. As president, John Kerry will establish an Office of Public Health Preparedness within FDA that will have the authority to contract with manufacturers, accelerate approval for vaccines and other drugs, and waive requirements without compromising safety and efficacy in the event of a public health crisis. This office will work with manufacturers and public health experts to ensure that red flags are addressed before a crisis ensues.
Research on faster vaccine production. Current flu vaccines are produced using antiquated methods. It takes almost a year to produce a new batch of vaccine, making it impossible to produce new supplies in times of crisis. As president, John Kerry will prioritize the search for faster and easier ways to produce a flu vaccine. He will direct the National Institutes of Health to expand research and promote adoption of more flexible and modern means of production by vaccine manufacturers.