While medical data is becoming more readily available for research, the results of clinical trials conducted by pharmaceutical companies often remain unpublished. Researchers have launched an international campaign to demand transparency.
Jul 16, 2014
report from the Cochrane Collaboration, a not-for-profit organisation, has recently pointed to the ineffectiveness of the drug Tamiflu in fighting certain flu complications.
This conclusion was based on the analysis of data provided by its manufacturer Roche, obtained after a long struggle. This small step perfectly illustrates the increased need
for transparency in clinical trials for researchers and doctors as well as for patients.
What could be nobler than helping research advance? Every year, thousands of Swiss people participate in the some 200 clinical trials organised to objectively judge the effectiveness of a medicine. Participants can hope to benefit from it one day (if they suffer from the disease) or at least contribute to medical progress.
Alas, these efforts are often in vain. Many results from clinical trials are never published, a serious issue. Half of these studies are never made public, according to Carl Heneghan, professor of Evidence-Based Medicine at Oxford University. He identifies the underlying problem: “It is impossible to determine the effectiveness of a therapy unless all of the results of clinical trials, without exception, are published.” Bernard Burnand, director of the Clinical Epidemiology Centre at the Lausanne University Hospital (CHUV), says, “It’s a real ethical issue for the participants, who believe they are contributing to research. In actual fact, these people are being deceived.”
The negative results mainly remain hidden, which overstates the value of the therapy tested. It is like flipping a coin and letting all the “tails” be ignored so that we can assert that we have an extraordinary coin that most often falls on the “heads” side. It is cheating, of course, but it is common practice in the medical field.
The consequences can be fatal. Published in the “New England Journal of Medicine” in 2000 and sponsored by the pharmaceutical company Merck, the main study on the toxicity of the anti-inflammatory drug Vioxx did not mention all the cardiovascular problems observed during the clinical trials. It took four years for Vioxx to be withdrawn from the market, after being taken by tens of millions of patients. According to a study by “The Lancet” published in late 2004, Vioxx was already responsible for some 38,000 fatal heart attacks by the time it was taken off the market.
The opaqueness surrounding clinical trials may come across as an outrage, but the pharmaceutical industry continues to defend it tooth and nail, generally justifying it to protect their industrial secrets. Despite our repeated requests, Interpharma (the organisation that represents pharmaceutical companies involved in research in Switzerland) was unavailable for a statement.
In July 2012, a group of Swiss academics and doctors founded the Health and Data Association to encourage dialogue on scientific, ethical, social, legal and political issues involved in the use of personal data. The organisation plans to create an online platform where patients can store all sorts of health data. “They can compile information on themselves, like their medical record or information they have collected on their own, like the hours of sleep they get or their eating habits,” says Ernst Hafen, the association’s co-founder. “Only patients will have an overview of their file. They will be free to choose what information they want to make available to researchers.” These data will be sold to pharmaceutical companies and other research institutions. The platform is still under construction and is managed like a cooperative. “Our goal is to help members benefit from the knowledge and profits that will come from the platform.”
Doctors strike back
The situation could change. In January 2012, Carl Heneghan and dozens of doctors (including British psychiatrist Ben Goldacre, author of “Bad Pharma”) launched AllTrials. This international campaign aims to convince public opinion, politicians and patient organisations of the need for a “paradigm shift”. The charter was signed by 420 organisations, only two of which were pharmaceutical companies. One of these was UK giant GlaxoSmithKline, which put its words into action by delivering researchers with the full summary of studies on the influenza inhibitor Relenza.
Another small victory was with Roche (which did not join the AllTrials campaign). After years of avoiding requests for access to data, Roche formed an expert panel to analyse all the clinical trials on Tamiflu, a drug whose effectiveness has been seriously challenged. The data has also been released to researchers from the Cochrane Collaboration, albeit in an impractical format. “We did not receive an electronic database, but PDF files,” says Peter Doshi of Johns Hopkins University in Baltimore.
Specialists are happy to see this shift but remain cautious. “The fight is definitely not over,” says Bernard Burnand, who has been involved since 2005 in the Ottawa Group, an organisation that supports the registration of clinical trials and the release of results. “We are waiting for tangible facts, not promises.”
In two decades, people will look back on this period in amazement, when data were not published.
One highlight is from the European Medicines Agency (EMA), which decided to publish full summaries of clinical trials data as of January 2014. But this openness can be met with legal action from pharmaceutical companies. In November 2013, InterMune and AbbVie managed to block the EMA’s publication of data. And the movement has not begun in Switzerland, where the regulator Swissmedic stated that it has no intention of publishing the results of studies.
Now we have to deal with the thousands of clinical trials that have already been conducted. They are tucked away in archives, far from those who have the most to gain or lose, i.e. doctors and patients. “In two decades, people will look back on this period in amazement, when data were not published,” says Carl Heneghan. “They’ll see it as incredible and preposterous.”
One highlight is from the European Medicines Agency (EMA), which decided to publish full summaries of clinical trials data as of January 2014.