[Spiegel] The Swine Flu Business - Should Germany Gamble Millions on More Vaccine?

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>>Gruhl has criticized the Robert Koch Institute (RKI), Germany's federal institution for disease control and prevention, as well as the Paul Ehrlich Institute (PEI), which is responsible for approving vaccines, for putting too much pressure on politicians to buy "more and more vaccines and drugs."And Gruhl isn't alone in his criticisms. Dietrich Wersich, for example, Hamburg's top health official, has also called for a halt in vaccine purchasing. "We believe that the already-ordered doses are enough for 30 percent of the population," he says. "But, when the PEI and the RKI recommend buying vaccine for 80 percent of Germans, they make the recommendation without knowing how much of the population is really willing to let itself be vaccinated." Such misgivings ultimately led to a secret meeting last Friday, at which the finance ministers of Germany's 16 federal states decided not to allocate any more money to the vaccine. They reasoned that, since Federal Health Minister Ulla Schmidt had not asked them to do so, then the federal government could foot the bill itself.<<=========http://www.spiegel.de/international/world/0,1518,647666,00.html#ref=nlint09/09/2009 03:02 PMThe Swine Flu BusinessShould Germany Gamble Millions on More Vaccine?By SPIEGEL StaffSwine flu hasn't caused nearly as many problems as some had predicted. Still, some worry that the next wave of the epidemic is going to be much, much worse. A debate is raging in Germany over whether to steer millions more to pharmaceutical companies for additional vaccine for the entire population.Matthias Orth is fighting on the frontlines against the epidemic. He works as a medical manager at the Marienhospital in the southwestern German city of Stuttgart. This is where the city's emergency health facilities are, and this is where the ill gather at night and on the weekends.Last month, there was a remarkable number of German tourists who came back from Spain coughing. They made a bee line from the airport to the hospital. "Suddenly, we had half of the busloads of tourists from Lloret de Mar standing here," Orth says, referring to a popular tourist destination on the Spanish coast just north of Barcelona.Still, the battle being fought at Marienhospital isn't really a matter of life or death. "The course of the disease is milder than that of a normal flu," Orth says, "so we've sent people home and told them to go to bed." He adds: "There's been such a fuss about this virus, but the fact is that it's really pretty run-of-the-mill. I'm going to get vaccinated against the normal flu, but not against swine flu!"Given his daily experience as a practicing physician, Orth is rather annoyed at the commotion over swine flu stirred up by state health officials. Germany has already ordered €500 million ($725 million) in swine flu vaccine, but now these officials are calling for another million doses -- for another €500 million."Nobody expected this pandemic to progress so mildly," says Stefan Becker, head of the University of Marburg's respected Institute of Virology.Global preparations for the next influenza pandemic had actually been modeled on those for the aggressive bird flu virus H5N1, which began causing numerous deaths in 2004. If it had been more easily communicable, that virus would have undoubtedly caused many more deaths. But, in the case of swine flu, a highly contagious pathogen has emerged, but one that is far less life-threatening."We probably just didn't notice before that there was an ongoing pandemic," Becker admits. "That's certainly happened on several occasions in the past."It's only been in the last few years that the Geneva-based World Health Organization (WHO) has supervised the establishment of a sophisticated monitoring system. From Afghanistan to Papua New Guinea, 128 reference labs are trying to make sure that any new flu strain will be rapidly detected.Worth the Expense?Still, the massive amount of funds devoted to this defensive network has made some wonder whether it has taken on a life of its own rather than remaining part of an overall health-care strategy."If something happens, nobody wants to be accused of having done nothing," says Matthias Gruhl, who oversees health policy in Bremen. "But this concern for safety is expensive," Gruhl adds. "It costs more than €1 billion, which could be spent elsewhere in the health-care system."Gruhl has criticized the Robert Koch Institute (RKI), Germany's federal institution for disease control and prevention, as well as the Paul Ehrlich Institute (PEI), which is responsible for approving vaccines, for putting too much pressure on politicians to buy "more and more vaccines and drugs."And Gruhl isn't alone in his criticisms. Dietrich Wersich, for example, Hamburg's top health official, has also called for a halt in vaccine purchasing. "We believe that the already-ordered doses are enough for 30 percent of the population," he says. "But, when the PEI and the RKI recommend buying vaccine for 80 percent of Germans, they make the recommendation without knowing how much of the population is really willing to let itself be vaccinated."Such misgivings ultimately led to a secret meeting last Friday, at which the finance ministers of Germany's 16 federal states decided not to allocate any more money to the vaccine. They reasoned that, since Federal Health Minister Ulla Schmidt had not asked them to do so, then the federal government could foot the bill itself.Who Should Be Vaccinated? And for How Much?In this game, the winner is always the pharmaceuticals industry. Indeed, drug companies are very adept at pushing policy -- and no company has been more brazen than Switzerland-based Novartis. Already on May 12, the group sent Germany's Health Ministry contracts that included a side-agreement that had not been previously agreed upon. According to the side agreement, the main contract would become void if vaccines were not ordered within 14 days.The federal states have still only signed the main contract and, therefore, agreed to prices that are up to 40 percent higher than those offered by the competition, GlaxoSmithKline (GSK). While GSK charges €8.33 per dose of vaccine, Novartis wants up to €11.90, depending on the order volume. Still, Novartis will only enter the picture with the second consignment of doses, as GSK will provide Germany's initial set of vaccines. In late July, the federal states ordered vaccine doses from GSK for 30 percent of the population for a net cost of €410 million. At that time, since nobody knew how the epidemic would progress, the order was only meant to be a security measure.But now, instead of just the chronically ill and members of at-risk groups and hospital staffs, PEI President Johannes Löwer wants to vaccinate the entire population. He's hoping to get some backing from the RKI's Permanent Vaccination Commission (STIKO), which met in Frankfurt for a special session on swine flu earlier this week and will issue a statement in favor of or opposed to mass vaccination. The commission seems very inclined to substantially expand the vaccination program. Its deputy chief, Ulrich Heininger, has said that the vaccine should be "offered to every person who wants to reduce his or her personal risk of infection."Still, questions have been raised about how unbiased and independent the commission is in making its recommendation. Critics note that Heininger -- and the majority of individual's on the STIKO panel -- get their information from reports, studies and presentations that are financed by vaccine manufacturers. And, in fact, some of the most generous sponsors of such information are GSK and Novartis -- precisely the two companies that will be providing the swine flu vaccine. And there are other ties as well, such as the fact that the commission's former head, Heinz-Josef Schmitt, went straight from working with STIKO to being part of Novartis' vaccine division.Panic and ProfitsCorporate lobbying activities are also having an effect. For example, last Friday, there was a great hubbub at the Federal Health Ministry, when rumors surfaced that Uzbekistan was planning to buy up the vaccine consignment intended for Germany. The rumor led ministry officials to call for a prompt decision to be made on whether to purchase more of the vaccine.For the pharmaceutical giants, the epidemic is developing into a business worth billions. Swiss banking giant UBS estimates that the sale of an extra set of vaccines will bump Novartis' revenues by €1.1 billion and GSK's by €1.5 billion -- and medical insurance will foot the bill. And whereas the cost of the vaccine in Switzerland will be €16, in Germany, it'll be a much steeper €28.Preliminary studies with the Novartis vaccine show that a single injection might provide adequate protection. But, for the moment, health officials are assuming that each individual needs to be vaccinated twice. So, with the 50 million vaccine shots of the existing order, 25 million people can be immunized.Even so, the fact still remains that no vaccine has been given final approval. "We sent blood samples to Novartis for analysis just a few days ago," says James Cramer, director of testing at the University Medical Center Hamburg-Eppendorf.In addition, vaccine production is extremely difficult. For example, manufacturers have been apprehensive about resorting to a new seed virus -- that is, the virus culture used to inoculate a new stock culture for vaccine development -- to boost production. "The amount of time needed for the vaccine to become widely available has been grossly underestimated," says Frank von Sonnenburg, the head vaccine researcher at the University of Munich.Will Things Get Worse?Meanwhile, officials in charge of dealing with epidemics are issuing repeated warnings about the possible emergence of a second -- and more intense -- wave of swine flu in the winter.But if you take a look at how the disease has affected Germany so far, there seems to be much less cause for alarm. According to a recent RKI publication, a review of the first 10,000 swine flu cases in Germany has revealed that, of those who have been infected (mostly 15- to 25-year-olds), not even one in 200 ultimately has come down with pneumonia, and some infections have run their course with few or even no symptoms.WHO experts, on the other hand, have issued more reassuring findings. According to their reports, most swine-flu-related fatalities have occurred with individuals with pre-existing conditions and weakened immune systems. Likewise, they also report that, to date, there is no evidence that the pathogen will become more aggressive through mutation.These findings seem to be backed by people working in German health-care facilities. Susan Huggett, for example, who is responsible for examining flu patients at Hamburg's Asklepios Clinic, says that all patients who have been diagnosed with swine flu have been immediately discharged. "Not even five patients were diagnosed with normal type B influenza," Huggett says, referring to patients who would need to remain in hospital for treatment."We have to be careful not to forget about the simple seasonal flu," she adds.MARKUS GRILL, VERONIKA HACKENBROCH, ALEXANDER NEUBACHER, GERALD TRAUFETTERRELATED SPIEGEL ONLINE LINKS: Profits From a Pandemic: A Swine Flu Windfall for GlaxoSmithKline? (07/23/2009) http://www.spiegel.de/international/business/0,1518,637748,00.html The World from Berlin: Who Should Bear the Costs of Swine Flu Vaccinations? (08/14/2009) http://www.spiegel.de/international/germany/0,1518,642468,00.html The Injection Business: How Safe Is the Swine Flu Vaccine? (08/03/2009) http://www.spiegel.de/international/germany/0,1518,640853,00.html Interview with Epidemiologist Tom Jefferson: 'A Whole Industry Is Waiting For A Pandemic' (07/21/2009) http://www.spiegel.de/international/world/0,1518,637119,00.html =====In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes.