Peter C. Gøtzsche is a Danish physician, medical researcher, and leader of the Nordic Cochrane Center at Rigs hospitalet in Copenhagen, Denmark. He co-founded, and has written numerous reviews within the Cochrane collaboration.

Among his research findings are that placebo has surprisingly little effect^[1][2][3] and that many meta-analyses may have data extraction errors.^[4] Gøtzsche and his coauthors have been keen to criticize the research methods and interpretations of other scientists, e.g. in meta-analysis of placebo.^[5][6]  Gøtzsche has commented on meta-analysis,^[7] and the editorial independence of medical journals.^[8] He has written about issues surrounding medical ghostwriting with the position that it is scientific misconduct.^[9] He has also criticized the widespread use of SSRI antidepressants.^[10] 

Books:

• Peter C Gøtzsche; Henrik R Wulff (2007). Rational diagnosis and treatment : evidence-based clinical decision-making (4th ed.). John Wiley & Sons. ISBN 9780470723685.

• Peter C Gøtzsche (2012). Mammography screening : truth, lies and controversy. Radcliffe Publishing.ISBN 9781846195853.

• Peter C Gøtzsche; Richard Smith, Drummond Rennie (2013). Deadly medicines and organised crime : how big pharma has corrupted healthcare. Radcliffe Publishing. ISBN 9781846198847.

  • Peter C. Gøtzsche (14 Dec 2012). Corporate crime in the pharmaceutical industry is common, serious and repetitive (pdf) (Report). Nordic Cochrane Centre. Retrieved 2014-06-04., and, in short version: Gotzsche, P. C. (2012). "Big pharma often commits corporate crime, and this must be stopped". BMJ 345 (dec14 3): e8462–e8462. doi:10.1136/bmj.e8462. PMID 23241451.

• Peter C. Gøtzsche (2015). Deadly Psychiatry and Organised Denial. People's Press. ISBN 978-87-7159-623-

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bmj-mailer@alerts.stanford.edu   Press releases: Monday 11 May to Friday 15 May 2015

Debate: Is the long term use of psychiatric drugs harmful?

The controversial topic will be discussed by leading experts at the Maudsey Debate, King’s College London

The benefits of psychiatric drugs have been exaggerated and the harms underplayed due to poor trial designs, argues one expert in The BMJ. But another expert and a patient contend that the evidence supports the use of these drugs.  More than half a million people aged above 65 years die from the use of psychiatric drugs every year in the Western world and the benefits would need to be colossal� to justify these immensely harmful� treatments, argues Peter Gotzsche, professor and director of the Nordic Cochrane Centre, Denmark.  But benefits are "minimal", he explains, adding that these treatments should almost exclusively be used in acute situations". New guidelines should support this change as well as widespread withdrawal clinics to help many patients gradually come off these medications.  Benefits have been over emphasised and harms understated, he says, because randomised controlled trials have been biased, not blinded appropriately, have not fully evaluated the effects of these drugs and deaths have gone under reported.  For example, the majority of studies have included patients already using a psychiatric drug and such patients may undergo abstinence and suffer from withdrawal symptoms. As a result, this study design exaggerates benefits and increases harms, and has even driven some patients to suicide, he explains.

Industry funded trials have under reported deaths, he adds, estimating that there have probably been 15 times more suicides among people taking antidepressants than reported by the US Food and Drug Administration (FDA).  He calculates that deaths from three classes of drugs:  antipsychotics, benzodiazepines and similar drugs, and antidepressants.  They were responsible for 3693 deaths every year in Denmark. This number corresponds to 539,000 deaths in the United States and European Union combined.  [Since the average age of suicide is about 40 years, this entails as measured by years lost a greater figure than cigarettes which kill mostly those over the age of 60 through heart attacks and secondly by cancer.]

The effects of psychiatric drugs are so small, he says, and that it would be possible to lower current use by 98%. He recommends stopping the use of all antidepressant, ADHD and dementia drugs, and prescribing only 6% of antipsychotics and benzodiazepines.  But Allan H Young, a professor of mood disorders at King’s College London, and John Crace, a psychiatric patient, argue that research supports the use of psychiatric drugs which are just as beneficial and efficacious as treatments for other common, complex conditions.  These drugs are needed, they insist, to reduce the long term harms of psychiatric conditions, which are the fifth leading cause of disability worldwide. Most patients suffer from co-existing health conditions, they add, a primary cause of death among this group.

They explain that psychiatric drugs are rigorously examined for efficacy and safety and while the evidence base is imperfect�, research shows that psychiatric drugs are more beneficial than harmful.  Careful evaluation of these drugs is undertaken before and after regulatory approval, they explain, and that post surveillance after a drug is licensed can include safety of a medication in the general population, which unlike study populations, includes people with varied medical conditions.

Yet concerns persist and many are overinflated, they add, and list recent studies supporting the use of lithium, once labelled a "toxic placebo", and antipsychotics, and treatments for mood disorders. But as with any drug treatment, the harms and benefits need to be evaluated from group data in trials, and be applied to individual patients whose subjective experiences are important to consider, they argue. 

For more information please contact:

Emma Dickinson
Tel: +44 (0)20 7383 6529
Email:edickinson@bmjgroup.com

Press Office telephone: 020 7383 6254 (Weekdays: 0900hrs to 1800hrs) 
British Medical Association 
BMA House, Tavistock Square, London WC1H 9J

New York Times article on Peter Gotzsche

CONFRONTING CANCER: SCIENTIST AT WORK--PETER GOTZSCHE; A Career That Bristles With Against-the-Grain Conclusions

CONFRONTING CANCER: SCIENTIST AT WORK -- PETER GOTZSCHE

By DONALD G. McNEIL Jr.  Published: April 9, 2002, New York Times

COPENHAGEN— Seated at an eerily neat desk in a modern office on the grounds of Denmark's state hospital, Dr. Peter C. Gotzsche does not seem a man whose bite is much worse than his very gentle bark.  But this tall, gray-haired statistician is sending some eminent doctors into fits of apoplexy as he quietly implies that they've wasted their lives defending old wives' tales, maltreated their patients or assisted in frauds that perhaps ought to land them in jail.

Most recently, he has made headlines for a study published in The Lancet in October concluding that the major studies of mammography do not show that mammograms can reduce death from breast cancer. 

Earlier last year, in The New England Journal of Medicine, he purported to pop the old shibboleth known as the placebo effect. Many doctors who have for years repeated what they had learned in medical school -- that about 35 percent of patients improve if you give them only a sugar pill -- learned that Dr. Gotzsche felt they had fallen for a theory as grounded in hard evidence as the one that swamp gas causes malaria.

In 1999, in The Journal of the American Medical Association, he argued that the research behind the Food and Drug Administration approval of fluconazole, an expensive and highly touted anti-fungal drug, was based on cooked books.

Before he was director of the Nordic Cochrane Center here and paid to make trouble like this, he was in private research. There, he asserted that a multinational drug company was deliberately overdosing AIDS patients with AZT because it was profitable to do so.

His critics say he is too harsh, rejecting important studies with small but acceptable data-collection flaws.  Dr. Gotzsche replies that he does not go around looking for trouble, but it seems to come looking for him.  ''We had no preconceptions about mammograms when we were asked by a government agency to look into this,'' he said in an interview in his blue and white office, where a thick stack of mammogram data fills drawer space. ''It just wasn't one of my interests.''  ''Now I've received more than 2,000'' -- he stops, and checks his computer -- ''I've received 2,276 e-mails about this. It's incredible what we've unleashed.''

Cancer researchers who still endorse mammograms have loudly attacked the work he did with his colleague Dr. Ole Olsen.  The seven landmark studies that back the use of mammograms for early cancer detection were begun between 1962 and 1982 in New York, Canada and Sweden. Dr. Gotzsche's specialty, meta-analysis, blends multiple study results. But he and Dr. Olsen found five too flawed to use; the remaining two showed no benefit.

Dr. Anthony B. Miller at the German Cancer Research Center said some of the five were precipitously thrown out because the authors couldn't or wouldn't answer all of Dr. Gotzsche's questions about their data.

Attacks on him have come from three groups, Dr. Gotzsche said: disinterested experts, oncologists who spent careers recommending mammograms, and those who earn money in the $1 billion screening industry.  The first group, he said, are ''academic and reasonable,'' the rest have vested interests ''and want to shoot the messenger.''

Dr. Gotzsche was born 53 years ago in Naestved, near Copenhagen, where his mother taught mathematics and home economics.   Her father, a doctor, was his role model. ''He was very bright,'' Dr. Gotzsche said. ''I never succeeded in beating him in chess.''  His own grandfather never once let him win?  ''No,'' he answered, looking perplexed. ''Fairness and honesty were important values in the family. I would have found it unfair if he lost to me on purpose.''  His first job was a paper route, and he planned to be a doctor, too, ''until I realized when I was 17 that many of my grandfather's patients really weren't ill.''  They were affluent women,'' he said. ''Seeing the doctor was a social event, so I decided it was a waste of time. I wanted to be a biologist and walk in rain forests.''

Instead, as a biologist, he went to work doing clinical trials for Astra Pharmaceuticals. But, disillusioned by its glowing pitches for the arthritis drug he tested, he started medical school in 1978. By 1990, he had a medical degree and a doctorate. His thesis: ''Bias in Double-Blind Trials.''  ''It was provocative,'' he said quietly. ''In 1990, the pharmaceutical industry had a good image.'' 

The thesis was read by Dr. Iain Chalmers, an Oxford professor who founded the Cochrane Collaboration, and invited Dr. Gotzsche to direct its Nordic branch.  The self-supporting collective, which has worldwide chapters in 50 medical specialties, was named for Archie Cochrane, author of a history of fatal flaws in medical practice, like the refusal by 19th century doctors to wash their hands between dissecting corpses and examining patients.  Its mission is to question medical tenets by analyzing all the trials of any treatment. It has, for example, compared 1,000 acupuncture studies and concluded there is no evidence it works, even for pain or smoking.  His placebo study, with Dr. Asbjorn Hrobjartsson, was done by hunting down trials that experts thought hardly existed: those with three patient groups, the treatment, a placebo and no treatment. They hoped to find a dozen, but by getting the United States National Library of Medicine to rewrite its software so ''Treatment: none'' could be searched, they found 130, in everything from herpes to nausea to schizophrenia. Over all, the untreated patients -- those still on the waiting list, for example -- got better at the same rate as those receiving placebos. ''We started the project believing there were important placebo effects,'' Dr. Gotzsche said. ''But when we finished, there wasn't much left.''

A small effect may exist in subjective symptoms, like pain, he conceded, but not in doctor-observable ones like swelling.

Dr. James M. Robins, a Harvard epidemiologist who follows Dr. Gotzsche's work, said he would probably have reached different conclusions. Dr. Gotzsche excluded acceptable mammogram studies and averaged pain studies in a way that made the placebo effect seem not to exist, rather than to exist in some studies for unknown reasons.  He called Dr. Gotzsche's harshness toward other people's randomized trial data ''unscientific and even bizarre.''  ''He seems to have a very black-and-white mind,'' Dr. Robins said. ''When he writes, he seems to be saying: 'You've done such terrible things against the pristine world of randomization that you're not going to be allowed in the covenant.' ''

Aware of his critics, Dr. Gotzsche said he was ''not cooking up difficulties or being nihilistic.''  ''There are many things in health care that, if you look at them closely, you are disappointed,'' he said.  His 1999 fluconazole study, done with Dr. Helle Krogh Johansen, his wife, attacked the research backing a drug that sells in the United States for $25 a pill for yeast infections and toenail fungus but also kills funguses that can be fatal to AIDS patients.  He found that studies by Pfizer, fluconazole's patent holder, compared oral doses to mixed results for amphotericin B and nystatin. But amphotericin B should be given intravenously and nystatin doesn't work at all, Dr. Gotzsche said, so the studies were, in effect, rigged.

In a later letter to the medical journal, Pfizer conceded that the comparison drugs did not work and that it would change how it reported results of trials. A Pfizer spokesman, Andrew McCormick, says the company stands by that response.

In 1987, Dr. Gotzsche said, he was the coordinator for all Nordic AIDS drug trials, and found that AZT was just as effective, with fewer side effects, at 400 milligrams as at 1,200 milligrams, the dose recommended by its maker, Burroughs Wellcome. The company, which sold it in 100-milligram pills, did not lower its recommendation, he said.

Patricia R. Seif, a spokeswoman for GlaxoSmithKline, which now owns the Burroughs Wellcome company, said 1987 was ''ancient history'' but recalled that the company's recommended AZT dosage was reduced from 1,200 to 600 milligrams in mid-1990, based on studies sponsored by the National Institute of Allergic and Infectious Diseases between 1986 and 1989. About the price-gouging accusation, she said the company cut its price for AZT by 20 percent in 1987 and another 20 percent in 1989.  No one she could find recalled Dr. Gotzsche's Nordic study, she said.

Asked if he had ever confronted Burroughs Wellcome by holding a news conference or getting a forceful group like Act Up into the fray, Dr. Gotzsche said he had not, then added: ''Perhaps we should have -- but that was not our style here in the Nordic countries.''