The business with the flu

The business with the flu
by Angela Spelsberg

In late October, the long-planned vaccinations against A / H1N1 started. It was already clear at this time: The expected pandemic with high morbidity and mortality has failed to materialize. From August to October 2009, the death rate worldwide increased from 1462 to 4735 cases, of which 3406 (1274) occurred in the Americas, while the death toll in Europe was 207 (after 53 in August). So far, less than 0.2 percent of sufferers worldwide have died. In Germany, only two deaths were reported by 16 October, which occurred in persons with severe underlying diseases - instead of the 23 to 138 death tolls expected after the approximately 23,000 cases of infection (assuming mortality rates between 0.1 percent and 0, 6 percent).

Despite these low values, the „swine flu“ amazing fears since April 2009, the first cases were known to Mexicans and US-Americans. Through travel, other countries were affected in the following weeks. „Now we have a pandemic of swine flu“ In a radio interview on May 1, Sir Professor Roy Anderson, UK Government Advisor, Rector of Imperial College London, was a member of the Scientific Advisory Council for Emergencies (SAGE) and a high-paid board member of vaccine maker GlaxoSmith-Kline (GSK) - specifically active in the fight against the swine flu.

But what is it about „New influenza A / H1N1 virus“ at all? That initially „swine flu“ said virus is a newly emerged virus variant (antigen shift) with proportions of influenza A / H1N1 viruses circulating in pigs, birds and humans. Characteristic of this influenza is a fast human-to-human transmission. However, the disease is shorter with only three to four days and the symptoms milder than with the seasonal flu. In addition, for decades, variants of A / H1N1 viruses have been circulating around the world that are only slightly different from the new ones „Influenza A / H1N1“ -Different type. That is why the „seasonal“ Flu vaccines have always been variants of A / H1N1 for years.

In fact, that is not exactly what it is „new virus“. This is also supported by the worldwide very low infection rate in people over 59 years. It is likely that this group of people, who are usually at risk from influenza, will have immunity from pre-vaccination.

Nevertheless, the beginning of June was the „New influenza“ upgraded to the highest alert level 6 by WHO. And despite the low mortality, the pandemic plan developed in 2005 also came into force in Germany - with provisions for protective measures, stockpiling and production of medicines and new vaccines. On October 12, the Standing Vaccination Commission (STIKO) published in the „Epidemiological bulletin“ their reasons and recommendations for vaccination. 2 As vaccination targets, the STIKO names the reduction of morbidity and mortality due to influenza. However, she leaves completely open how she wants to achieve this, given the unprecedented increase in morbidity and mortality.

In the US, four non-adjuvanted (ie not potentiated) vaccines against swine flu were approved at the end of September, the production of which corresponds to the usual seasonal vaccines. The STIKO, however, recommends the use of adjuvanted vaccines that are not approved in the US. This new vaccination strategy has been criticized by many experts in advance of the introduction because of the lack of safety and testing of these preparations. 3 Evidently, the Bundeswehr also has significant doubts about the new vaccines. For example, it became known that the responsible Federal Armed Forces had ordered a non-adjuvanted vaccine for their soldiers - which is why the Halle microbiologist Alexander Kekulé has already received one „Vaccination GAU“ speaks. 4

This raises the question of when „pandemic“ Influenza vaccines must be used at all. The national pandemic plans include 6 mass vaccinations at pandemic level „Pandemic vaccines“ before, after the first effectiveness tests a very shortened, so-called „Mock-up“-Admission received. According to the European Council of Experts, this approval tool was created only in view of the dangers of the spread of Asian avian influenza (influenza A / H5N1), which is fatal in more than 60 percent of the patients. When the first human cases occurred in 2003, a global wave of panic set in. Although in all of the 130 cases that became known by the end of 2005, there was always direct contact with birds („zoonosis“) and no human-to-human transmission could be demonstrated, the WHO and national health authorities warned of a possible pandemic by mutant H5N1 viruses with high human hazard. With leading vaccine manufacturers (such as Novartis, GSK) developing technical developments and patents for faster mass production of vaccine viruses (in cell culture and genetic engineering), regulatory authorities have now been forced to cut down on necessary approval procedures - for example, in new vaccines 240 days. These monovalent mock-up vaccines against influenza contain only a reduced amount of antigen of a virus type (3.75 or 7.5 µg instead of 15 µas in the seasonal vaccines), but various new adjuvants and the mercury-containing thiomersal as a preservative. Although none of the vaccines have been tested for efficacy and safety on pregnant women, the RKI recommends vaccination for pregnant women from the second trimester onwards.

Loud „drug telegram“ the initiated vaccination campaign in Germany will devour at least € 700 million, and even up to € 2 billion for the reordered applications 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 vaccine (plus twice five euros for vaccination) is even higher than the price of the seasonal vaccine: this costs about 14 euros per immunization on the basis of manufacturer's selling prices. The large order for the provider is extremely cost-saving: The usual costs for sales promotion omitted. Typically, large corporations spend about a quarter of their sales on marketing and advertising. Despite the size of the order, the associated conditions are not publicly available. This obscures the conflicts of interest of those who negotiated the terms.

Intransparency and conflicts of interest
The German government ordered 50 million cans worth 700 million euros from the vaccine manufacturer Glaxo-Smith-Kline (GSK) in Dresden. Already since the proclamation of „Swine flu pandemic“ The value of the GSK shares rose by ten percent and the GSK quarterly profit in the third quarter to 2.4 billion euros. A further 2.3 billion profit is expected in the quarter, which will see the delivery of the „Swine flu vaccine“ coming.

The new „pandemics“ are definitely a safe deal for manufacturers. And every year again, if not as fast as possible „stopping-rules“ to set the all-clear on suspected but harmless pandemics - as well as public scrutiny of decision-making, including disclosure of contractual agreements between vaccine manufacturers and government. Health resources of this size, which are urgently needed elsewhere, can no longer simply be distributed behind closed doors in the future. Intransparency and potential conflicts of interest undermine the credibility of the relevant recommendation and regulatory authorities. Even more: in the current case, they nourish the suspicion that the H1N1 influenza wave was used as a swine flu pandemic targeted by the pharmaceutical industry for marketing. A detailed examination of the events by a parliamentary commission of inquiry is therefore urgently required.

Obviously, the existing mechanisms to ensure the independence of STIKO are not sufficient, in particular as regards conflicts of interest. In order to change this, the minutes of the meetings and the decisions taken, and above all their justifications, should be published in principle.

After all, the members of the STIKO since August 2008 after many years of pressure, such as Transparency Germany, their potential conflicts of interest on the STIKO website revealed. The current data from March d.J. show that the majority of the current 16 members have more or less intensive contacts with the major vaccine manufacturers. Individual members also conduct vaccine studies or work in close co-operation with vaccine manufacturers. Furthermore, it can be read that some of the STIKO members are in favor of the „Forum vaccinate“ which in turn enjoys financial support, among others, from Sanofi-Pasteur-MSD. The website of the forum 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 regulatory authority EMEA, whose work Transparency Germany has been observing critically for years. Most problematic is that the EMEA is under the responsibility of the Directorate-General for Economic Affairs of the European Commission and not the Directorate-General for Health and Consumer Protection. Equally worrying is the fact that nearly two-thirds of the work is funded by the pharmaceutical industry - and a review of the registration documents by external scientists is generally only possible after successful approval. As long as this is not effectively remedied, the current scandal of swine flu vaccination may not have been the last of its kind. be of his kind. be of his kind.

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1 See www.who.int/csr/swineflu/en.
2 Cf.. „Epidemiological bulletin“, 41/2009, p. 403-426
3 Cf. Swine flu: everything under control? In: „medical telegram“ (a-t) 9/2009.
4 Cf.. „The daily level“, 15.10.2009.
5 Cf.. „at“, 40/2009, p. 77-80.