Debate on open access to clinical trial data at TACD-HAI event

Calls echo round European Parliament for wider access to clinical trial data

by Peter O’Donnell

BRUSSELS, June 6 (APM) – Excessive secrecy about medicines in development is putting the health of European citizens at risk, members of the European Parliament and academics alleged Wednesday.

At a seminar in the parliament today, Peter Liese, a physician and a leading health spokesman for the majority European People’s Party in the parliament, said: “We don’t have enough transparency about the results of clinical trials and about possible side effects.”

“We want better access to data for those who work for the good of patients,” he stated.

The seminar was organised by the Transatlantic Consumer Dialogue and one of its European members, Health Action International Europe, and supported by a cross-party group of MEPs.

A succession of speakers presented a long catalogue of what they alleged were examples of industry bias and duplicity, from Vioxx to Tamiflu.

They also denounced what they saw as major loopholes in the regulation of trials and deficiencies in the overall approach to drug development.

According to the director of the Nordic Cochrane Centre, professor Peter Gotzsche, the situation had led to thousands of unnecessary deaths, millions of patients suffering unnecessary misery, and incalculable wastes of research energy and taxpayers’ money.

In addition, said Gotzsche, most published trials are biased, and the lack of impartial information makes informed consent “a delusion”.

“If commercial or academic success depends on withholding data that is important for rational decision-making by physicians, patients and governments then there is something fundamentally wrong with our priorities in healthcare,” said Gotzsche.

“We need access to raw data.Tables are not enough,” he insists.


Professor Wolf-Dieter Ludwig, chairman of the Drug Commission of the German Medical Association, said that the duty to provide access to clinical trial data has not been met in Europe in recent years.

He blamed a conflict between the goals of protecting commercial interests and promoting rational prescribing.

“The evidence base on which prescribers are obliged to make their choice of therapy was largely determined by industry-sponsored clinical trials and misleading and inaccurate publicity at launch,” he said.

“We do not get the information we need for prescribers and patients,” said Ludig, citing the case of reboxetine, which, he said, had been shown to be ineffective, but only in assessments that had remained unpublished.

He also attacked what he described as weaknesses in clinical trial registries – notably because they depend on clinicians’ readiness to submit data.

Clinical investigators and trial sponsors do not routinely comply, said Ludwig, and even when results are reported, they are often very late. “Europe lags behind the USA on transparency on clinical trials,” he claimed.

“It is neither desirable or realistic to maintain the status quo,” he said – but expressed fears that the situation was unlikely to change much in the foreseeable future.

Other speakers attacked the design of trials, which could, it was argued, permit manipulation that would lead to biased results. The European Medicines Agency came in for repeated criticism too, particularly for obscurantism in responding to requests for access to information.


During the course of the debate, Dr Hans-Georg Eichler, senior medical officer at the European Medicines Agency, underlined that the agency was now committed to a new approach, and had opposed the industry view that CT data is commercial confidential.

“It is unacceptable that any clinical trial should disappear under the rug,” he said. “We strive to improve our performance with all the trials that come our way.”

But he warned that while raw data has great potential as a resource, it was vital to protect patient confidentiality.

In addition, raw data is “a tool that can also be put to bad use”, with the risks of false analysis conducted to further careers, to stoke controversy, or to raise personal profile. The results could, he cautioned, be “phantom risks or miracle cures”.

It is not possible to distinguish between different public groups, on who should have access to data, he said, “but there should also be full transparency on any analysis – notably distinguishing exploratory from confirmatory conclusions.

Eichler frankly apologised for EMA’s “stupidity” on occasions, in responding to data requests with material that was almost entirely obliterated.

He told APM that he did not believe that in these days of clinical trial regulation it was possible for trials to disappear, since authorisation was required.

His concerns, he said, focused on metastudies, which anyone can do without authorisation, and can lead to false conclusions that can be damaging to health – as in the case of Wakefield and MMR.