It could be the end of the eternal caveats: almost exactly one year Ago, the research network Cochrane published to Use report, and risks of the vaccination against human papilloma virus (HPV). The pathogen can cause cervical cancer and the protection vaccination provides, nevertheless, for years for Controversy. Because of his incorruptibility and meticulousness, admired and also feared network of researchers Cochrane wanted to ensure the report actually, for clarification. Instead, he plunged the organization into a deep crisis, which continues to this day. And Impfzweifler feel in your Reserved.
to understand the meaning of the operations, it helps to know the role of Cochrane. The international group of academics and Physicians, influenced with its comprehensive overview, guidelines, work decisions, Therapy and, increasingly, the remuneration of medical services. Properly known as the network due to its reports on the strong sales of the Flu drug Tamiflu, which it is attested only modest efficacy.
The reputation of Cochrane is now threatened. "We have to be careful not to damage the good reputation that we have over decades built up," says Erik von Elm, Director of Cochrane Switzerland. At the annual strategy at the beginning of April meeting in Krakow poring the Cochrane guide staff about how to go on. And among the members it was bubbling. The demand for reforms is in the room.
Lit., the crisis in the 242-page report of the Cochrane team, Marc Arbyn Belgian cancer centre Sciensano, on 9 May 2018 appeared. The authors analyzed 26 studies on the effectiveness and vaccine safety, with over 70'000 girls and women over a period of up to 8 years. The conclusion: "evidence of high quality showed that the HPV-to protect vaccines against precursors of cervical cancer in young girls and women."
vaccination rates break
The real stumbling block, however, was the conclusion: "We found no increased risk for serious side effects." In the studies reported deaths were classified as not having the vaccine contiguous. The authors called for long-term care follow-up, among other things, because of the potential for less damage. The outrage that changed nothing.
The HPV vaccination is for well over 15 years in use, and has so far shown a good effectiveness. In Switzerland, it recommends that the Federal office of public health since 2007 for girls and young women, since in 2015 for boys. In many countries reservations against cancer protection are circulating, however. Today, the fear of side effects is especially in the foreground. Among other things, in Denmark and Japan, are therefore, according to the media, the initially high vaccination coverage reports dropped dramatically. The suspicion: The HPV vaccination could cause autoimmune reactions in the rare circulatory disorder POTS or the pain syndrome, CRPS.
"The objections are not weighty enough to have the vaccination to withdraw."Erik von Elm,
the chronic fatigue syndrome CFS as a result will be discussed. Authorities after analysis, no Association between the disease and the vaccination. However, there is considerable doubt that the manufacturer of a HPV vaccine has been collected in the pivotal trials with unexpected side effects always correct. This could show the US online magazine "Slate" with an extensive Research.
The critics with probably the biggest reputation comes from its own ranks: Peter Gøtzsche. He was until recently head of the Nordic Cochrane centre in Copenhagen, a member of the Cochrane Board and founding member. Prior to that, the physician and natural scientist has worked many years in the pharmaceutical industry and distrusts since then, the industry.
In an article in the journal "BMJ Evidence-Based Medicine" published, he and two colleagues, two and a half months after the HPV report, Cochrane a harsh criticism: The authors have disclosed conflicts of interest; in addition, severe side effects, as well as almost half of the existing studies had not been adequately taken into account.
scandal of the year
Cochrane was allowed to perform with external experts, an investigation, and dismissed in consequence of the criticisms of Gøtzsche as "much exaggerated": It has only been a small number of studies missed, the changed also the result of the original HPV report. Also in terms of the potential for serious side effects in a transparent and responsible had been reported to be "aware". And there have been no violations of the rules for conflicts of interest.
On Tuesday, 16.September 2018, escalated the dispute. During the annual meeting of the Cochrane network in Edinburgh, the governing body Peter Gøtzsche from the organization of the castle. Reason of his many years of "destructive and inappropriate behavior," the "of the work, the reputation, and the members of the organization was detrimental." The decision fell short and led to four of the protest resignations from the governing body. Many feared censorship, threatening the academic freedom. Gøtzsche himself complained of "the growing authoritarian Top-Down culture and an increasingly commercial business model," the "scientific, moral, and social objectives" of Cochrane threatened.
"I don't understand," says Erik von Elm, who was not involved in the decisions. He put into perspective the allegations of Gøtzsche: The squabbling of the HPV report, I brought the barrel only to Overflow. "Peter Gøtzsche has always been strong on confrontation," he says. "So he has achieved for the organization, the governing body of the cooperation, however, was apparently very difficult." Elm assumes that everything is received with the right things: "It is the usual process: After the publication of the report, all the criticism may attach, which is then analyzed and leads to a Update, if necessary, a correction."
What relates to the Use of the HPV vaccination, the Swiss Cochrane-Director of Elm in no doubt: "The expressed objections against the Review, are weighty enough, for the vaccination to withdraw."
"death of a Whistleblower"
An Update of the HPV report, however, have to wait. It was the sensibilities very well aware, on request, at the London press office of Cochrane. However, there is "no sufficient cause for concern", the Update is preferable.
Gøtzsche has processed his experiences meanwhile in the E-Book "The death of a Whistleblower and Cochrane moral collapse". Even otherwise, the 69-Year-old continues to be as a critic is active and expresses itself in journals, at conferences and his Blog. The drastic Name: "Deadly Medicines and Organised Crimes".
treatment decisions should be based on scientific facts and not on a diffuse gut feeling based. That this is the case today, in fact, more often than in the past, is in good part thanks to pioneers such as Archie Cochrane. The 1988 deceased British doctors has repeatedly criticized the Lack of scientific Evidence for therapies and published in 1972, this ground-breaking book "Effectiveness and Efficiency". It is considered as the start of "evidence based medicine".
The Briton is the name of the, founded in 1993, the Cochrane Collaboration. The global network of scientists and Doctors and analyses in systematic reviews of the research to medical therapies and evaluated. Every year, several Hundred such Reviews appear, a total of around 8000 in the Cochrane Library are currently available.
reports is often abused
it is understood that The global network is made up of a core team in London, local specialist groups and the national Cochrane centres. Financial support by the pharmaceutical industry is taboo.
Switzerland has, since 2010, a private Cochrane centre at the University of Lausanne. It consists of four persons, which ensure that the collected Knowledge of Cochrane is available, including General-to-understand summaries in German and French. But the Cochrane Team, external authors, supports work when Writing a Overview. "In the end, all of which have the necessary Know-how to write a Cochrane Review," says Director Erik von Elm. In General, these are researchers at universities or hospitals.
For the review must be worked with a specified methodology to wrong conclusions. The finished work will be reviewed, then published and can be finally commented. Subsequent Updates take into account new data and criticism.
In the centre of Cochrane Reviews patient-related issues. So, if a treatment prolongs Survival or improves quality of life. "Indirect parameters such as laboratory values are only partly meaningful, and are taken into account in the rule, only on the edge," says von Elm. This focus leads to use on the Patient again and again to misunderstandings. About medicines, which are not yet long enough on the market to show an effect on Survival. Often, a Review comes to the conclusion that there is not enough data for the evaluation are available. Elm: "This does not mean that Intervention is ineffective."
Created: 14.05.2019, 17:47 PM