Peter Gøtzsche, MD, DrMedSci, director of the Nordic Cochrane Center at the Rigshospitalet, Copenhagen, Denmark, has been expelled from membership of the governing board of the Cochrane Collaboration, a position to which he was elected in early 2017.
After his expulsion, four other members of the governing board resigned — Gerald Gartlehner, David Hammerstein Mintz, Joerg Meerpohl, and Nancy Santesso, the Cochrane Collaboration Governing Board announced on September 15.
The shake-up comes at a rather awkward moment, as the announcement was made just as a large international meeting of the organization was unfolding — the 25th Cochrane Colloquium, which is taking place in Edinburgh, Scotland, from September 16-18. The meeting has attracted 1300 participants from 57 countries. The theme for this year is “Cochrane for all: better evidence for better health decisions.”
Accused of Causing “Disrepute”
“No clear reasoned justification has been given for my expulsion aside from accusing me of causing ‘disrepute’ for the organization,” Gøtzsche writes in a letter dated September 14.
“In just 24 hours the Cochrane Governing Board of thirteen members has lost five of its members, four of which are centre directors and key members of the organization in different countries,” he writes.
The Cochrane Collaboration has entered an unchartered territory of crisis.
“As a result, the Cochrane Collaboration has entered an unchartered territory of crisis and lack of strategic direction.”
In the three-page letter, Gøtzsche gives his version of what led to his expulsion.
The Cochrane Collaboration is “a scientific, grass-roots organization whose survival depends entirely on unpaid contributions from tens of thousands of volunteers and substantial governmental support throughout the world,” he explains.
“We make a substantial contribution to people’s understanding and interpretation of scientific evidence on the benefits and harms of medical interventions, devices and procedures that impact the population,” he writes.
“Our work informs government legislation globally, it influences medical guidelines and drug approval agencies. Therefore, the integrity of the Cochrane Collaboration is paramount. We pride ourselves on being global providers of ‘trusted evidence’ on a foundation of values such as openness, transparency and collaboration.
“However, in recent years Cochrane has significantly shifted more to a business — a profit-driven approach,” he writes. “Even though it is a not-for-profit charity, our ‘brand’ and ‘product’ strategies are taking priority over getting out independent, ethical and socially responsible scientific results.
“Despite our clear policies to the contrary, my centre, and others, have been confronted with attempts at scientific censorship, rather than the promotion of pluralistic, open scientific debate about the merits of concrete Cochrane reviews of the benefits and harms of health care interventions,” he writes.
“This is not a personal question,” Gøtzsche writes. “It is a highly political, scientific and moral issue about the future of Cochrane.
“What is at stake is the ability of producing credible and trustworthy medical evidence that our society values and needs,” he comments.
“As most people know, much of my work is not very favorable to the financial interests of the pharmaceutical industry. Because of this Cochrane has faced pressure, criticism and complaints,” he writes. “My expulsion is one of the results of these campaigns.”
Recent Cochrane Review of HPV Vaccine
In recent years, however, he has spoken out against scientific reviews of the HPV vaccine.
In 2016, his center filed a complaint against the European Medicines Agency (EMA) over its handling of safety issues concerning HPV vaccines.
The EMA had looked at the safety issue last year after a request from Denmark, where physicians had documented in the medical literature case reports of chronic symptoms in girls who had received HPV vaccines. After conducting a review of HPV vaccine safety, the EMA concluded that “evidence does not support that vaccines cause” the chronic symptoms. However, several European researchers questioned the review process, and the Nordic Cochrane group, headed by Gøtzsche, lodged an official complaint, arguing that the official EMA report is flawed.
That Cochrane review, published online on May 9, 2018, concluded: “There is high‐certainty evidence that HPV vaccines protect against cervical precancer in adolescent girls and women who are vaccinated between 15 and 26 years of age. The protection is lower when a part of the population is already infected with HPV. Longer‐term follow‐up is needed to assess the impact on cervical cancer.”
The authors also stated that HPV vaccines “do not increase the risk of serious adverse events, miscarriage or pregnancy termination. There are limited data from trials on the effect of vaccines on deaths, stillbirth and babies born with malformations.”
His coauthors, Lars Jørgensen and Tom Jefferson, are colleagues from the Nordic Cochrane Center in Copenhagen. They also both work at the Center for Evidence Based Medicine, University of Oxford, United Kingdom.
The review “missed nearly half of the eligible trials…[and] was influenced by reporting bias and biased trial designs,” they write.
The trio had harsh criticism on many issues: all of the trials that were included in the review were sponsored by industry; the trials used composite surrogate outcomes for cervical cancer; and none of the trials used a placebo as a comparator. (They used active comparators, which “probably increased the occurrence of harms in the comparator groups and thereby masked harms caused by the HPV vaccine,” they comment.) In addition, the review “incompletely assessed serious and systemic adverse events” and “did not assess HPV vaccine-related safety signals.”
In their conclusion, the three authors point out that “part of the Cochrane Collaboration’s motto is ‘Trusted evidence.’
“We do not find the Cochrane HPV vaccine review to be ‘Trusted evidence,’ as it was influenced by reporting bias and biased trial designs,” they write. “We believe that the Cochrane review does not meet the standards for Cochrane reviews or the needs of the citizens or healthcare providers that consult Cochrane reviews to make ‘Informed decisions,’ which also is part of Cochrane’s motto.”