Таймс опубликовала статью и редакционную, посвященную проблеме сокрытия информации о клинических испытаниях. В Евросоюзе готовится директива,

требующая раскрытия данных клинических испытаний для исследователей. Ряд компаний требуют поправок, кастрирующих этот документ

Clinical Cloud: Data from trials of new drugs must be fully available to independent scrutiny

Medical science depends on evidence. Were it left merely to hunch and intuition, even of the mostskilled practitioners, then patients’ safety and welfare would be put at risk. Hence it is vital, both for patients and for public confidence, that clinical trials of medicines are open and transparent.

Yet pharmaceutical companies are lobbying to prevent the public release of the full data from these trials. It is a short-sighted and misguided intervention on specious grounds.

Campaigners for transparency cite cases in which drugs have been released where full data would have revealed possible side-effects or caveats about effectiveness. They include Tamiflu, a medicine for flu treatment and prevention, and Seroxat, an antidepressant. In the case of Seroxat, manufactured by GlaxoSmithKline, independent researchers found that the full clinical data suggested a link to suicide and self-harm among teenagers taking the drug. The summary results had not revealed it.

The pharmaceutical companies’ concerns are not groundless. They are justifiably wary of compromising the anonymity of patients who are involved in the trials. And research conclusions are intellectual property. Yet the evidence is that the balance is falling too heavily against disclosure. Especially, but not only, in the field of mental health, successful treatment varies widely.

Antidepressants may have side-effects or indeed may have no effects. The science is not speculative but it is a field where research can take unpredictable paths. It is the ethos of science is that no one has the last word and that everyone’s research is subject to review. Yet scientists maintain that pharmaceutical companies are summarising data at such a high and aggregated level that they are rendering it incapable of being independently checked. An article in the technical journals will typically be some 10 to 15 pages long, whereas the data set on which it is based will be huge.

The temptation to present the results in a favourable light, without qualifications, is a natural human impulse. That is why the data needs to be available in full. The pharmaceutical companies are becoming more open and are in principle committed to transparency. A voluntary standard is being developed by the European Medicines Agency, a collective of national regulators, that would make full data from clinical trials available for all drugs that come to the market. This will be implemented next year, and is likely to become morewidely invoked as an international standard.

Yet the regulators have no transnational powers. The standard will be voluntary. Some pharmaceutical companies are seeking to accomplish transparency through a standard championed by their own consortium, called Transcelerate. Its methods seem unimpeachable: a wish to publish data while protecting the anonymity of patients.

Yet the actual techniques proposed seem to result in data so limited or heavily redacted as to be incapable of full peer review. Pharmaceutical companies need to have incentives to pursue research. Market mechanisms, subject to rigorous regulation, are a proven method of expanding the boundaries of knowledge. Yet without the full data, and with purely summary results, pharmacological research will be more of a marketing than a medical exercise.

That is in no one’s interests.

The Times 2015 10 27

Drug makers accused of trying to hide test results

Pharmaceutical companies are lobbying to block the public release of clinical trial data in a move that campaigners say puts patient safety at risk.

A European transparency initiative is proposed to ensure that when regulators approve new drugs the full data from the trials would be publicly released, rather than just a summary published in a medical journal. The proposal comes after high profile cases in which independent researchers found that drugs such as Tamiflu or the antidepressant Seroxat were more dangerous or less effective than pharmaceutical companies had claimed.

In the case of Seroxat, a GlaxoSmithKline drug, the full study reports had been restricted. When researchers accessed the papers, they found that the drug was linked to self-harm and suicide in teenagers—even though the drug company’s summary of the research had said that it was safe and effective.

Campaigners have said that while all companies are ostensibly onboard with the reforms, some are now asking to be allowed to redact so much data before the release that it would effectively lead to the removal of all useful information. The pharmaceutical companies say that they are doing this to ensure that details of patients involved in the trial remain confidential.

Other scientists argue that the approach effectively renders the whole exercise pointless. “Healthcare professionals cannot reliably inform patients of the potential benefits and potential harms of medicines when the underlying clinical trial data is kept secret,” said Peter Doshi, from the University of Maryland school of pharmacy, who has campaigned for the release of all data. “Without raw data, we are left vulnerable to trusting at face value journal articles that may, in truth, be little more than marketing dressed up as peer-reviewed science.”

Tom Jefferson, a British researcher based in Rome who works for the respected Cochrane Collaboration, a volunteer health organisation, said that there was amoral, as well as a practical, necessity to change the regulations. He said that the transparency initiative would be undermined if much of the data were redacted. “If you carry out an experiment on a human you have certain responsibilities,”Mr Jefferson said. “One of those is that you shouldn’t suppress data.”

Both scientists said that it should be possible to make the patients anonymous without rendering the research useless. “Journals have articles ten to fifteen pages long,” Mr Jefferson said. “The underlying data set is tens of thousands of pages long. This means they can present the product in the best possible light — which is what they’ve been doing. We’ve got abundant, overwhelming evidence this is the case.”

Research released this year showed that when industry sponsors medical trials of its own drugs they are backed 97 per cent of the time. This is why the European Medicines Agency, a London-based umbrella organisation for national regulators, is working to introduce a voluntary code for the release of all data as drugs come to market, so that other researchers can reassess it as necessary.

Researchers involved in the discussions have told The Times that several companies want a strict approach to make this data so anonymous that, when applied to real-world examples, such as the Tamiflu research, it removes virtually all the information. A spokesman for the European Federation of Pharmaceutical Industries and Associations said it was working to “balance responsible reporting for public health benefit and safeguarding patient confidentiality”. Professor Doshi said that it was imperative that the data remained usable. “After years, we finally have a system that’s soon to go live and make trial data public,” he said. “But at the last minute, there’s a move that could render the system useless.”

Tom Whipple Science Editor