In Part 1 and Part 2 this series of articles I have commented on the serious health problems, which leads to the introduction of the chickenpox vaccine with it: For the vaccinated children, the babies vaccinated mothers and - the raised shingles - risk. and for the total population
time I go into the question of how it is possible that we knowingly Sun to pursue a direction and go one way, the future generations, largely without alternating possibility hostage increases. The answer is as commonplace as unworthy of a society that to its high democratic maturity boasts: In the immunization seem crucial principles of scientific work suspended. The authorities fail in their control function and a lobby of Impfexperten may want to exercise and how it pleases
argument 5. The recommendation for universal varicella vaccination was not due to health reasons, but for the good the vaccine industry and decided on the initiative of its close links with experts lobby
After German official vaccination schedule babies get in the first two years of life, now eleven vaccinations before twelve to protect diseases, including four doses of a six-fold and two doses of a quadruple vaccine. Compared to the eighties, the number of vaccinations has more than doubled.
What is the vaccination schedule, determine the experts of the Standing Committee on Vaccination (STIKO) at Berlin's Robert Koch Institute. Especially in recent years has done much here. With recommendations for the varicella, pneumococcal, meningococcal and HPV vaccination four new products were included in the official vaccination schedule. Until recently, the health insurance companies could decide whether to play for the costs. Since a change in the law, which came into force in July 2007, however, they are obliged to: What recommends the STIKO and the "Federal Joint Committee (JCC)" approved, it must be paid for by health insurance.
For manufacturers vaccinations are largely risk-free business. In contrast to other drugs used here is the patent protection will not. Therefore, there is no cheap copycat drugs (generics), the prices can be set at any height. And being able to play even the Impfexperten and recommend vaccination in general, even breaking out the land of plenty for the vendor companies: Due to the mass vaccination of an entire birth cohort provided by paragraph, without the marketing departments of corporations themselves are still active . Would And demanded for a more modern for the vaccination also significantly higher prices and paid for, is the former "Groscherlgeschäft", which join in the pharmaceutical industry alongside with good will to become a real financial market hopes. Vaccine manufacturers are currently considered the most lucrative segment of the total pharmaceutical market. Even the most bizarre concepts such as a vaccine against tooth decay, high blood pressure or Alzheimer's disease will find the confidence of investors and stock exchanges are start-ups with such vaccines in the portfolio as a pilot. But they promise huge profit margins if it is possible to bring them to market - at most comparable with novel Drugs in cancer therapy.
sparked the current boom gave the U.S. company Wyeth. He presented in 2001 with "Prevenar" from his new vaccine against pneumococcus, calling for a time as a completely crazy prestigious award of more than 100 €. As a result, has led in many countries to fierce debate as to whether this extremely expensive vaccine should be paid for by health insurance or not. "This vaccine costs for children's vaccinations would have doubled at a stroke," explained the Mainz pediatrician Heinz-Josef Schmitt, the former long-time chairman of the Standing Committee on Vaccination (STIKO).
STIKO is a Ministry of Health established an independent expert commission, whose recommendations to the German vaccination schedule will be implemented. Because of the close financial ties to vaccine manufacturers to Impfexperten fell in recent years in the crossfire criticism. Above all, her boss. "HJ" Schmitt (photo), he describes himself as happy in its opinions and contributions, had accepted for years highly paid research contracts from the vaccine manufacturers. Also in the studies on pneumococcal vaccination, he was involved. Yet he was allowed to discuss the status of the technical questions STIKO vaccination with. Only for the voting itself, he had to wait outside the door. Schmitt made to me no bones about the fact that he campaigned vigorously for the recommendation for pneumococcal vaccination: "This has properly requires brains, to which was recommended," he said to me in an interview on tape. "We have used six years." a pharmaceutical lobbyist as chairman of the independent commission of experts giving're already one of the features that have been tolerated in Impfbereich many years in Germany. Almost every year new vaccinations were in Schmitt's auspices on the scene: in addition to pneumococcal or meningococcal and varicella. The closure was eventually the vaccine against human papillomavirus (HPV). Meanwhile, had the cash to the enormous Amounts for new vaccines apparently already used. The HPV vaccine Gardasil, presented with a prize of 450 € for the basic immunization on again a spectacular new record. As early as 2007 Gardasil sales jumped from 267 million euros on top of the top-selling drugs. And although it is only during the first half at all come on the market. Schmitt had forced the flash-approval in the STIKO vehemently.
How secure these men felt and how of course they are in full public view with the industry put to bed, shows a small episode, which probably would be possible in any other branch of science - and in the economy would probably be prosecuted. Sun HJ Schmitt did not have any doubts, just before the the recommendation of the HPV vaccine through the STIKO officially again soon a price "for the promotion of Impfgedankens" to accept, which was endowed with a sum of 10,000 €. Was donated the sum of Gardasil maker Sanofi-Pasteur MSD.
Wolfgang Becker Brüser, editor of industry-independent "drug-Telegram" rebelled:
"How can you accept as a publicly witness a price from a pharmaceutical company whose products I have are too? - Those are like public corruption "
for HJ Schmitt have been 10,000 euros in comparison to his other income a relatively paltry sum, the look was still devastating. This episode characterizes the self-perception of Impfbranche but excellent: A clique of experts in the gray zone of opaque financial braids not the least by the process of each other gifts to the public with industry funding: because they Impfgedanken - promote this good - at the expense of contributors. Such a lack of awareness is wrong that has been practiced here for years little public criticism and virtually no control by the competent authorities.
In the fall of the same Schmitt took the year as its price and the vaccine manufacturers with a blank subscription to the HPV vaccines nor for years to billions of euros of revenue secured, suddenly as he thanked Professor Mainz and down as chairman and STIKO moved completely to the side of vaccine manufacturers. Schmitt is now Vice President Global Medical Affairs at Novartis Behring.
But even after leaving the majority of Schmitt STIKO members has many ties to industry. Only five of 16 members of the Infection Protection Act enshrined "independent body" to advise the Ministry in vaccination issues today are completely or largely free of financial ties to manufacturers the vaccines. It decide STIKO recommendations as to which vaccinations are reimbursed by the statutory health insurance.
How can such conflicts of interest may affect the health practice described to me, "Off the Record" a senior official of the Austrian Health Ministry, discussed with the representatives of a U.S. drug company over the possible treatment by the tax payer. supposedly independent - - Impfexperten present for the negotiations, some were. "The atmosphere was heated up and became more aggressive," the official told me, "because the Americans were determined to enforce the reimbursement by health insurance." There was even threatened with a public campaign, which should stand up, the then Minister of Health was to blame for the death of hundreds of children. "And the worst thing that our Impfexperten are worse behaved than the American." We have noticed absolutely no difference, said the official, who is now employed by the pharmaceutical company and who was a supposedly independent expert.
In the self-reported STIKO members on the website has been the Robert Koch published Institute , there's often an indication that held "talks on Impfthemen without product terms," whose "professional fees partly funded by vaccine manufacturers (re) " were. This may sound rather suspicious. In practice, hidden behind such formulations, however, often appeared on pharmaceutical advertising and promotion. A typical example is the appearance of the Cathedral Stiko member Klaus Wahle at a meeting of Sanofi Pasteur MSD, the manufacturers of the vaccine "Zostavax" against herpes zoster (shingles). According to a report of the doctors' newspaper this event was Professor Wahle stuck up for vaccinations, such as this "record capped services provided by statutory health insurance" in the. For "the zoster vaccine complements the annual influenza vaccination and every six years recommended pneumococcal vaccination in an ideal manner and should therefore be recommended as the standard vaccine quickly. "
The Robert Koch Institute no details about the amount of additional income so obtained. Fees are well into four figures for such appearances but certainly with the market. As a small supplement to the meager salary professor.
The deputy chairman of the STIKO, Ulrich Heininger, received by all major vaccine manufacturers, lecture fees, acts as a consultant for the company and accepted invitations to attend scientific meetings.
How should such persons be able to bring in their own independent financial links with expertise in the STIKO? When I spoke to Fred Zepp to these conflicts of interest, said he told me crossly:
"If you do not like, so you must STIKO just filled with housewives."An argument that what you want well that the science of vaccination is so very complicated that the only people with close relationships industry in general are able to understand. The largely uncritical
proximity to industry is not only a feature of the German Impfexperten scene. The chairman of the Austrian Impfausschusses the Supreme Medical Council, Ingomar Mutz is, for example, not too stupid for this, both as active volunteer president of the Austrian Green Cross to act, a lobbying association for vaccine-PR. Claire Anne Siegrist, in turn, the President of the Federal Commission for Vaccination is on the fee schedule of nearly all major vaccine manufacturers.
behaves similar in almost all other countries. Nowhere has managed to build a reasonably clean, the people, not the interests of the pharmaceutical industry shall advise beings. And also applies to international organizations the same. The World Health Organization is also saturated with lobbyists like the health authorities of the United States or the European Medicines Agency EMEA. Here, the access of the industry itself is the fact that the "independent" Authority under the Industrial Commissioner and whose budget is financed to a substantial part of the contributions of the pharmaceutical industry.
The recommendation for varicella vaccination in Germany was close to approval of GSK's product Priorix-Tetra a quadruple vaccine, in addition to measles, mumps, rubella and chicken pox now containing the component. Previously, created as with the introduction of the chickenpox vaccine in the U.S., some cost-benefit analysis, which all showed that the public saves money when the chickenpox vaccine is generally used as a children's vaccination. Almost all of these studies were paid for by the manufacturers. Controversial, partly manipulated data were used as the base, negative circumstances - such as the expected cost explosion in the treatment of shingles - however, simply ignored. And such studies were then - called by STIKO in its justification for the introduction of vaccination - without any sense of shame.
both in the medical profession as well as health insurance, there was initially little understanding of this step. Were the insurance so far always followed the expert advice of STIKO, was issued a week later an official announcement of the leading associations of health insurance, which the scientific basis of the decision was challenged. Not meet the minimum STIKO study data nor the findings complication would be understandable. The available funds should be invested rather heavily in the eradication of measles, as kick off a new vaccination strategy with questionable outcome. In 95 percent of cases the disease was completely free of complications, so the argument runs. Only by the vaccine increased the risk that the chicken pox be made a serious illness.
Other critics, such as the editor of the independent drug- telegram Wolfgang Becker Brüser threw STIKO before too great a proximity to the pharmaceutical industry. We have often the impression, Becker-Brüser that she thinks of the rights of producers than those of subjects would be safeguarded. "With this ever-escalating recommendations do the authorities ensure the Impfgedanken any favors. "
the Munich-based pediatrician Martin Shepherd also urgently warned against this" uncontrolled human experiment. " It would be a mistake to believe that each disease prevented automatically gain. "For infections such as chickenpox may have a positive effect on cancer or other diseases later in life," said Shepherd. "One was to investigate any case thoroughly before this creates a constraint that is not reversible."
Ex-Chairman STIKO HJ Schmitt understood the fuss over the decision is not in the least. "The most important was the reason for the general chickenpox recommendation that every year 750 000 cases of illness can be avoided, "he said. "Every child will benefit individually from the chicken pox vaccine because it does not become ill."
Like Schmitt tried the Viennese Impfexperte Wolfgang Maurer, the familiar argument that avoided any disease is in itself a gain. "The complication rate for chicken pox is 1 to 4,000," said Maurer. "It's unfair if you do not save the children unnecessary suffering." the Munich-based epidemiologist and expert Rüdiger von Kries STIKO (photo), was equal to my questions frankly admits that the combination preparation of GSK one of the reasons for the STIKO recommendation was.?
"I was long skeptical of the chickenpox vaccine vaccination must be really against varicella, the varicella vaccine makes it easier in the first place the lives - serious .... morbidity and mortality are rare One must be careful to achieve high immunization rates to provide sufficient herd immunity to achieve this is only possible if there is a combination vaccine that is now on the market and now can say: why not ? - chickenpox do not make fun and sometimes even life-threatening complications that point to be vaccinated twice, so maybe that's life... one will sometimes have to be vaccinated three times. Nothing is for nothing. "
It is worth closer to see where the experts cited by the high risks of chickenpox suddenly come forth. Earlier, the STIKO yes more than ten years, saw no reason to follow the U.S. example. The decisive was therefore a new study who came to the conclusion that occur each year in Germany around 5,700 serious complications, including about 22 deaths as a result of chickenpox. These figures are far above what was previously known about the dangers of chickenpox .
But how did the study? For this was a telephone survey conducted among physicians. 3,500 called doctors said, 300 ready to talk. They were asked to register any of its filter out patients who suffered from chicken pox. "Well, hardly has a doctor on a computer system where it can filter out by simple random any patient who was suffering from chickenpox," said medical journalist Michael Houben in a WDR report the fundamental flaw of this approach. "The doctors are in such a normally the case in front of a large file and try to remember which patient was being treated for chicken pox. Logically, that remain especially severe cases especially in the memory. "Their complication rate was by statisticians then extrapolated to the population. A methodology that is based on the criteria of evidence-based medicine on a totally frivolous.
is telling to look at the study's authors. Among them are employees of the Basel company Outcomes International, indicates on his website following as the "mission" of the Company:
"We support our customers in the pharmaceutical, biotech and medical device industry in the commercialization and marketing of their products."Thus should the client and the financier of the study have been so pleased. It was the company GlaxoSmithKline (GSK), shortly after the publication of the study with Priorix-Tetra Germany as the world exclusive premiere of a combined vaccine against measles, mumps, rubella and chicken pox brought to market.
But the mission of the chickenpox vaccine is not yet over. For there is still resistance nests that hold the old tried and tested over decades vaccination scheme: namely, only those children and young people aged from nine years to be vaccinated who have not previously been through the disease naturally. Such a pocket of resistance in Europe such as Switzerland.
But here are the professionals of "Outcomes International on behalf of GSK active again: For instance with a current calculation that the introduction bring the general varicella vaccination course for the Swiss health system would spare them, "... even if they turn out not seen since the recommendations for a schedule of two doses for primary immunization as impressive.
How little has changed in the behavior code of "independent" Impfexperten concerning their financial relationships with industry shows a view of the authors of this study: Of course, once again the STIKO is in the boat. Namely in the person of vice-chairman Ulrich Heininger, who had no qualms with the employees of the pharmaceutical services company to act as study author.
Conclusion: It is high time that the immunization be applied to basic principles of scientific work. It can no longer be left to a conspiratorial lobby of Impfexperten to adopt vaccination campaigns for almost an entire population of the wrist. Without systematic review of available evidence, without HTA, without well-organized and financially independent monitoring of the results.
As it currently looks, the general varicella vaccination and must be a gross mistake as soon as possible be taken back!
Otherwise we run the risk that changes the current appearance of the chickenpox as a largely harmless childhood disease drastically, and results in a severe - is life-threatening illness - - for some age groups, and benefit only those of them who sell vaccines or helping with their expertise here.
Photo Credits: Süddeutsche Zeitung (HJ Schmitt), bright- koepfchen.de (F. Zepp), Impfbrief.de (Rv Kries)
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