on the right track…

Posted on Tuesday 5 February 2013

A Tough Push For Clinical Trial Disclosure In Europe
By Ed Silverman
February 4th, 2013

As the debate over clinical trial transparency heats up, the lead legislator for the Environment, Public Health and Food Safety Committee in the European Parliament wants to toughen proposed legislation that is designed to bolster clinical trial practices and activities on the continent. And one of her suggestions is already meeting with some resistance from the pharmaceutical industry. Specifically, lead legislator Glenis Willmott wants full clinical studies – not summaries – to be submitted and, therefore, available for disclosure. “Your rappoteur is the opinion that a sample summary of the results from the sponsor does not go far enough, as it could be biased or misleading,” she writes in a statement released late last week. Rappoteur is the lead legislator on a bill; Willmott is from the UK, by the way.

In her view, company data can be protected in line with existing measures, although drugmakers continue to raise concerns that trade secrets could be compromised. In fact, the Association of British Pharmaceutical Industry issued a statement saying that, “if the entire file with all studies is released other companies can get approvals around the world. Anyone can get an approval as long as they submit the necessary data.” Nonetheless, Willmott is adamant and proposes to fine drugmakers that do not submit all pertinent clinical trial information to a database within one year. And she also believes that all data should be archived indefinitely, instead of the five-year period proposed by the European Commission. “Should a sponsor come under investigation for misconduct, the clinical trial master file would be vital,” she writes [here is her report]…

Transparency, though, has arguably been the most contentious of the various issues addressed in the legislation. Last month, the Health Committee at the UK’s National Institute for Health and Clinical Excellence has issued a report calling for drugmakers to place all information in “the public domain” and create a voluntary code for publicly releasing trial data for drugs once they have been reviewed and made available for clinical use [back story]…

“The demands by Dr. Goldacre and the British Medical Journal to release patient-level clinical trial data are irresponsible with potentially harmful consequences for future medicine development. The recommendations would jeopardize patient privacy and could serve as a deterrent to individuals considering participation in trials. It would also encourage second-guessing of the regulatory approval process, which would be disastrous for patients. The FDA has the most advanced and rigorous review process for potential new medicines and it is continuously improving its regulatory and scientific capabilities,” PhRMA says in its statement.
Glenis Willmott has clearly done her homework. Having spent more hours than I’d like to admit poring over the various kinds of summaries posted and turned in by the pharmaceutical industry, they are essentially of no use in vetting a clinical trial. They are as vulnerable to distortion and deceit as the published articles. She knows what she’s talking about [and even better, she seems to know that she knows what she’s talking about]. The comments of PhRMA are the usual kinds of things they say. But whether there’s truth in what they say or not, the behavior of the pharmaceutical industry in the recent past strips them of any wiggle room. Raw data from clinical trials is a non-negotiable target. It’s hard to even find an industry funded study that makes it into print factually unblemished. From her report:

    One of the major problems at the moment is the lack of transparency of clinical trial results. This has reduced public trust in trials and their findings. Independent academics often find it difficult to get the data they need to verify the results of trials and carry out systematic reviews, and a lot of data is withheld. It is also known that when trials are unsuccessful the results are often never published or made available at all. Trials can be carried out repeatedly before it becomes public knowledge that they are ineffective or even dangerous. The Commission is proposing some big steps forward in terms of transparency, by proposing that a publicly accessible, EU database on clinical trials is set up, holding information on all trials, successful or not. However, your Rapporteur is of the opinion that a simple summary of the results from the sponsor does not go far enough, as it could be biased and misleading.

    Your Rapporteur is therefore recommending requiring sponsors to publish a full clinical study report on the EU database. The clinical study report is already a generally accepted international guideline and a comprehensive account of how the trial was carried out, and what the findings were. Many sponsors already prepare these reports, which are submitted to the regulatory bodies when applying for marketing authorisation. It includes a simplified summary, but also the much fuller results which can be analysed and checked by independent researchers. Clearly patients decide to take part in a trial to help advance medicine for themselves and other patients in their situation, not to help a particular company. Sharing more knowledge about trial results will not only increase trust in medicines, but accelerate the development of live-saving treatments. It will not compromise data protection, as all personal patient data will be anonymised.

The only thing the pharmaceutical industry will lose is the right to make false claims. So it will change the industry and will likely change the practice of medicine. And that’s the whole point. We can add Glenis Willmott to the list of people who are on the right track – leading the effort to put integrity back into the domain of pharmaceutical clinical trials in medicine.
    berit bj
    February 5, 2013 | 4:50 AM

    Enough is enough! I’m reminded of citizen Rosa Parks, who refused to give up her seat to some white person, igniting awaiting tinders, lighting a bigger flame than a the tired woman on a bus in the US South imagined at her moment of resistance.
    Politicians like Glenis Willmott need the resistance of many, to go into the fry and (try to) enforce new, just rules on the way big business is done, to protect us, the commoners everywhere.
    I take note of the committee of which she is a British Labour member, chaired by a German Social Democrat, heading The Progressive Alliance of Socialists and Democrats in the EU Parliament, for the Environment, Public Health and Food Safety. Interconnected. Strongly linked to human rights globally. I see that 1BOM archives (most? all?)posts under politics. Right you are, doctor. It’s politics more than anything else, for human rights, for social justice.

    February 5, 2013 | 2:40 PM

    Interesting news that Glaxo have now agreed to publish the results of all its drug trials:


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