The Cochrane Collaboration, a highly respected international medical research organisation that conducts systematic reviews and guides clinical practice, has been rocked by a scandal. Professor Peter Gotzsche, a founding member, was recently expelled from its board, following a narrow vote. Gotzsche was accused of bringing the organisation into disrepute, but four other experts on the board walked out in protest at the decision.

Gotzsche, a Danish clinician, is a big name in medical research. Among other things, he is the coauthor of several guidelines on the conduct and reporting of research, including CONSORT, PRISMA, STROBE and SPIRIT. And, until last week, Gotzsche led the Nordic Cochrane Centre in Copenhagen.

Some people regard him as a maverick – he isn’t shy of speaking out. Others see him as a principled man whose commitment to the doctrine of evidence-based practice is displayed in his criticisms of flawed research, particularly when this is due to vested interests. Integrity is the bottom line for Gotzsche.

Commenting on the BMJ website, Trisha Greenhalgh, while not privy to the full details of the case, implied that Gotzsche could be seen by some as a technical purist whose rigidity could rile more pragmatic members.

Greenhalgh, a leading research methodologist, has criticised the Cochrane “hierarchy of evidence”, which places experimental trials above any other study design, and affords limited value to qualitative research. She urges a more inclusive approach to evidence-based practice: “Facts are not self-interpreting; they are theory and value-laden.”

Indeed. But if evidence is presented from a randomised controlled trial, it should be the result of a scientifically robust investigation. This is the best method for assessing effectiveness because it minimises bias through random sampling and blinded assignment to treatment or placebo. A clear logical process should be followed by the investigators. Yet sometimes, as Gotzsche has documented, research is not done well. And if done properly, research is not always reported – arguably, because the result was undesirable.

High profile

In recent years, Gotzsche has had a high public profile. His enquiring and sceptical mind led to his discovery that the placebo effect in research is negligible and that meta-analyses, a method of review that reanalyses original study data, was rife with data extraction errors.

He has taken a strong ethical stance against ghostwriting in medical research. Perhaps most controversially, he has argued that screening for breast cancer does more harm than good and that psychiatric drugs are damaging.

One in six adults in the UK takes antidepressant tablets daily, yet the effectiveness is doubtful for most patients. Indeed, instead of relieving depression, these drugs are taken for years, causing chemical dependence. An unholy alliance of biomedically orientated psychiatry and the pharmaceutical industry has created a vast and lucrative market. The evidence has been distorted by selective reporting.

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Gotzsche’s article in The Daily Mail on the harms of psychiatric drugs (handed out “like Smarties”) attributed the shortened lives of people with severe mental illness to their prescribed treatments. This drew angry responses from psychiatrists, who are mostly in favour of pharmacological treatments (which they control) and less than enthusiastic towards the value of psychotherapies (which they don’t control).

David Nutt, best known for demanding that the government decriminalises illicit drugs, despite the obvious harm that they cause, accused critics such as Gotzsche of inciting headlines on antidepressants that “plumb a new nadir in irrational polemic”. In response, Gotzsche repeated his list of charges against pharmaceutical companies and their supporters, arguing that the explosion in antidepressant dependence is a waste of money, while remarking on the sweeteners given to some of his critics by drug companies: “There has been heavy marketing and widespread crime committed by drug companies, including fraud, illegal promotion, and corruption of psychiatrists.”

Booted out

Gotzsche was upsetting the apple cart. After negative publicity and complaints, the Cochrane Collaboration issued a statement. As a research organisation, “Cochrane’s ability to take part in debate is damaged if we are falsely perceived to have taken a partisan position that we do not hold”.

But Gotzsche caused further consternation with his allegations of bias in a Cochrane review of the human papillomavirus vaccine, which apparently understated the side effects of this jab. Gotzsche and fellow authors were accused of risking the lives of millions of women by affecting vaccine uptake rates.

This was the last straw. The dissident was booted out.

In a letter giving his side of the story, Gotzsche argued that the Cochrane Collaboration is pursuing a business model to the detriment of scientific independence. Evidence-based medicine is at enormous risk of manipulation by commercial parties, unwittingly aided by practitioners, professional bodies and patient groups, although I suspect that some beneficiaries know what they’re doing.

Gotzsche ended his letter thus: “This is not a personal question. It is a highly political, scientific and moral issue about the future of Cochrane.”

His persistent criticisms of the drug industry have resulted in a campaign to silence him, but patients might suffer if this hegemony is immune to challenge. Scientific integrity or commercial compromise – that is the choice faced by a hallowed institution.