The flu business



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The flu business by Angela Spelsberg

The long-planned vaccinations against A / H1N1 started at the end of October. At this point it was already clear that the expected pandemic with high morbidity and mortality had not materialized. From August to October 2009, the death rate worldwide rose from 1462 to 4735 cases, of which 3406 (1274) cases occurred in the Americas, while the death toll in Europe was 207 (after 53 in August). So far, less than 0.2 percent of those affected worldwide have died. In Germany, as of October 16, only two deaths were reported that occurred in people with serious underlying illnesses - instead of the expected number of 23 to 138 fatalities after the approximately 23,000 cases of infection (with assumed mortality rates between 0.1 percent and 0, 6 percent).

Despite these low values, the "swine flu" has triggered astonishing fears since the first cases became known to Mexicans and Americans in April 2009. Other countries were also affected by travel in the following weeks. “Now we have a swine flu pandemic,” said on May 1 in a radio interview Sir Professor Roy Anderson, British government advisor, Rector of Imperial College London, member of the Scientific Advisory Council for Emergencies (SAGE) and at the same time a high-paying executive board member of the vaccine Manufacturer GlaxoSmith-Kline (GSK) - especially active in the fight against swine flu.

But what is the “New Influenza A / H1N1 Virus” all about? The virus, initially known as “swine flu”, is a new virus variant (antigen shift) with parts from influenza A / H1N1 viruses that circulate in pigs, birds and humans. A fast person-to-person transmission is characteristic of this influenza. However, the course of the disease is shorter with only three to four days and the symptoms are milder than with seasonal flu. In addition, variants of A / H1N1 viruses have been circulating around the world for decades, which differ only slightly from the new "Influenza A / H1N1" type. That is why the "seasonal" flu vaccines have always contained variants of A / H1N1 for years.

In fact, it is not a “new virus”. This is also supported by the very low infection rate worldwide for people over 59 years of age. This group of people, who are usually particularly at risk from influenza, is likely to be immune from pre-vaccinations.

Nevertheless, at the beginning of June the "New Influenza" was upgraded to the highest alarm level 6 by the WHO. And despite the low mortality, the pandemic plan developed in 2005 came into force in Germany - with regulations for protective measures, stockpiling and production of drugs and new vaccines. On October 12, the Standing Vaccination Commission (STIKO) published its reasons and recommendations for vaccination in the "Epidemiological Bulletin". 2 The STIKO names vaccination targets for reducing morbidity and mortality from influenza. However, she leaves it completely open as to how she intends to achieve this - given the unprecedented increase in morbidity and mortality.

At the end of September, four non-adjuvanted vaccines against swine flu were approved in the United States, the production of which corresponds to the usual seasonal vaccines. The STIKO, on the other hand, recommends the use of adjuvanted vaccines, which are not approved in the USA. This new vaccination strategy was criticized by many experts in advance of the introduction due to the lack of safety and testing of these preparations. 3 The Bundeswehr obviously also has considerable doubts about the new vaccines: it became known, for example, that the responsible Bundeswehr agencies have ordered a non-adjuvanted vaccine for their soldiers - which is why the Halle microbiologist Alexander Kekulé is already talking about a “vaccine meltdown”. 4th

This raises the question of when "pandemic" influenza vaccines have to be used at all. At pandemic level 6, the national pandemic plans provide for mass vaccinations with “pandemic vaccines” which, after the first effectiveness tests, are given a very shortened, so-called “mock-up” approval. According to the Expert Council for Europe, this approval instrument was only created with a view to the dangers of the spread of the Asian bird flu (influenza A / H5N1), which is fatal to over 60 percent of the sick. When human cases first appeared in 2003, a wave of panic began around the world. Although direct contact with birds (“zoonosis”) and no human-to-human transmission could always be detected in all of the 130 cases known by the end of 2005, the WHO and national health authorities warned of a possible mutated pandemic H5N1 viruses with high danger to humans. Since leading vaccine manufacturers (e.g. Novartis, GSK) had developed technical developments and patents for faster mass production of vaccine viruses (in cell cultures and genetic engineering processes), the regulatory authorities have now also been instructed to shorten the necessary approval procedures - for new vaccines to about 240 days. These monovalent flu mock-up vaccines contain only a reduced amount of antigen of a virus type (3.75 or 7.5 µg instead of 15 µg as in seasonal vaccines), but various new adjuvants and the mercury-containing thimerosal as a preservative. Although none of the vaccines on pregnant women have been tested for their effectiveness and safety, the RKI recommends vaccination for pregnant women from the second trimester.

According to “arzneitelegramm”, the vaccination campaign that has started in Germany will devour at least 700 million euros, and up to two billion euros for the reorders under consideration. 5 Expectations that the lower antigen content leads to significantly lower prices compared to conventional production were disappointed. The now fixed price of 18 euros per double vaccination (plus two five euros for the vaccination) is even higher than the price of the seasonal vaccination: This costs around 14 euros per immunization based on the manufacturer's selling price. The large order is extremely cost-saving for the provider: the usual costs for sales promotion are eliminated. Large corporations typically spend around a quarter of their sales on marketing and advertising. Despite the size of the order, the associated conditions are not publicly available. This hides the conflicts of interest of those who negotiated the terms.

Lack of transparency and conflicts of interest
The federal government has ordered 50 million doses worth 700 million euros from the vaccine manufacturer Glaxo-Smith-Kline (GSK) in Dresden. Since the “swine flu pandemic” was proclaimed, the value of GSK shares has risen by ten percent and GSK quarterly profit in the third quarter to 2.4 billion. Another 2.3 billion profit is expected in this quarter in which it is to Delivery of the "swine flu vaccine" is coming.

The new "pandemics" are definitely safe business for the manufacturers. And that every year, if "stopping rules" are not introduced as soon as possible to give the all-clear for suspected but harmless pandemics - as well as public control of decision-making processes, including the disclosure of contractual agreements between vaccine manufacturers and the government. Health resources of this magnitude, which are urgently needed at other locations, may no longer simply be distributed behind closed doors. Lack of transparency and potential conflicts of interest undermine the credibility of the responsible recommendation and approval authorities. Even more: In the current case, they fuel the suspicion that the H1N1 flu wave was used as a swine flu pandemic by the pharmaceutical industry for marketing purposes. An exact screening of the processes by a parliamentary commission of inquiry is therefore urgently indicated.

Obviously, the existing mechanisms to ensure the independence of the STIKO are not sufficient, especially with regard to conflicts of interest. In order to change this, the minutes of the meetings and the decisions made, but above all the reasons for them, would have to be published.

After all, the members of the STIKO have been disclosing their potential conflicts of interest on the STIKO website since August 2008 after years of urging, for example by Transparency Germany. The current information from March of the year show that the majority of the current 16 members have more or less intensive contacts with the most important manufacturers of vaccines. Individual members also conduct vaccination studies or work in close cooperation with vaccine manufacturers. It can also be read there that some of the STIKO members are committed to the “Forum Vaccination”, which in turn receives financial support from the Sanofi-Pasteur-MSD company, among others. Unfortunately, the forum website does not give any indication of the financial amount of this support.

In the case of swine flu, the vaccine was approved by the European approval authority EMEA, whose work Transparency Germany has been extremely critical for years. It is extremely problematic that the EMEA is subordinate to the Directorate General for Economic Affairs of the European Commission and not to the Directorate General for Health and Consumer Protection. Equally worrying is the fact that almost two thirds of their work is financed by the pharmaceutical industry - and a review of the approval documents by external scientists is only possible after approval has been given. As long as no effective remedy is found here, the current swine flu vaccination scandal may not have been the last of its kind. of his kind. of his kind.

Swell

1 See www.who.int/csr/swineflu/en.
2 See "Epidemiological Bulletin", 41/2009, pp. 403-426
3 See swine flu: Everything under control? In: “arznei- telegram” (a-t) 9/2009.
4 See “Der Tagesspiegel”, October 15, 2009.
5 Cf. "a-t", 40/2009, pp. 77-80.

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