When trial outcomes are wholly or partly hidden, and when clinical trial data is not subject to full transparency, the best evidence will not be available to treat patients. In these cases there is a clear danger that patients will receive treatments that would not have been provided if the full picture were known. In the worse cases, a company may have information that would discredit a particular treatment but not wish to publish it for commercial reasons. I hope these cases are rare but they do happen, as readers of this blog will know.

I was surprised, then, to find that patient groups are not very vocal or active in demanding full access to clinical trial data. I scanned the websites of the European patients federations affiliated to the European Patients Forum (EPF). Many deal with important issues around informed consent to participation in clinical trials but not with the wider issue of how the results might be used later. (In fairness, some patient groups focus on direct patient support rather than on wider political or policy issues.)

The EPF did cover the issue in its submission on the revision of the Clinical Trials Directive,calling for the publication of all clinical trial results, positive or negative, in the EU Clinical Trials Data Base, and in an understandable and user-friendly way.

Publication of all clinical trial results would be an important step forward, but not enough. Companies would still have enormous power to choose which results to present and how to present them. Access to clinical trial data is essential to bring the full power of science and sound evidence to the treatment of patients.

There are varous partnership platforms and projects between industry and patient organisations, including (at EU level) EPPOSI and EUPATI but they seem to give little attention to the need for publication of all clinical trial results, or better access to clinical trial data.

I hope patient groups will become more assertive on the need for transparency and good science here. END

One is a paper by Peter Gotsche, essentially a written version of his address to a seminar in the European Parliament which I covered in a previous post. This is a short but in my view conclusive argument for access to clinical trial data.

In a second more technical article by Ross and others the authors deal with some of the complications of gaining access to data , while pointing out that in current circumstances “..patients, physicians and other health care professionals, and the research community are .. making clinical or research decisions with access to only a fraction of the relevant clinical evidence that might otherwise be available.”

(This is surely a cause for patients’ organisations to promote.)

An editorial by Krumholz also makes a powerful case for access to trial data and does so in clear and non-technical language. A second editorial, by Spertus is more technical and also more cautious about the practicalities of achieving full access to trial data, while acknowledging the merits of the case for doing so.

All four articles are well worth reading with the two by Peter Gotsche and Harald Krumholz making easier reading for the layperson.

My thanks to Marilyn Mann who told me about these articles and who runs a blog that I like a lot. Have a look here.

Take the Glaxo diabetes medicine, Avandia (rosiglitazone), withdrawn from the European market in 2010 and subject to severe restrictions in the US. Did the company have information from research that might have led to an earlier withdrawal if it had been made publicly available sooner?

Well, yes, according to the US Senate Finance Committee which accused the company in July 2010 of failing to publish in good time a number of studies that showed problems with Avandia, and of using “ghost-writers”, professional writers paid by the company, to present the results of their clinical trials.

One Glaxo study in particular, of a competing drug Actos, indicated that Avandia had a worse profile, and the Committee cited internal company emails arguing that “…these data
should not see the light of day to anyone outside of GSK…” and that there should be no study comparing Avandia with Actos.

In their response, the company sharply rejected the claims, accusing the Committee of releasing a small subset of the millions of documents in the case, including “..drafts and other documents taken out of context, which therefore are incomplete and misleading”.

The company also said that the Actos study was of a competing product (true) and that the results were consistent with what was already known about the competing product, and “did not contribute any significant new information”.

As for two other studies cited by the Senate Committee the company said that they had submitted the data from these studies to the US FDA.

On the allegation of ghost-writing the company said that they follow, and did follow in this instance, “…established authorship practices modelled after the International Committee of Medical Journal Editors (ICMJE) guidelines…”

I have taken the Senate Committee’s intervention here because it is relatively easy to describe in a blog, but there had been many complicated controversies about Avandia for some years previously. You can read more about Avandia, and the case for more transparency, in an article by Peter C Gotzsche entitled Why we need easy access to all data from all clinical trials and how to accomplish it.

In future posts I will look at other cases that seem to me to illustrate the need for more transparency in relation to clinical trials. I have also intended for some time to look at medical writing, sometimes pejoratively described as “ghost-writing”. This is the widespread practice of pharmaceutical companies employing professional writers to prepare drafts of reports of clinical trials, for submission to peer-reviewed journals. END

European health ministers have poured cold water on a long-standing EU proposal to allow pharmaceutical companies to provide information on medicines directly to patients.

Ministers say the Information to Patients Directive could increase red tape for government agencies and companies if they are required to vet information which is designed for public consumption.

EU law currently prohibits companies from advertising to consumers but, as part of the 2008 “pharmaceutical package” of new medicines legislation, the European Commission proposed allowing some factual information about medicinal products to be published in newspapers and magazines.

Consumer groups were sceptical of the original plan, fearing it would open the door to the kind of hard-sell drug advertising commonly seen on television in the United States.

MEPs were equally uneasy about some aspects of the Commission’s proposal and insisted that safeguards be put in place to ensure any information shared with the public is objective rather than repackaged marketing material.

The saga has been a case study in how the slow-moving machinery of EU legislation works: the Commission proposes a new law, MEPs amend it in several parliamentary committees before voting on it, and then it falls to the European Council where health ministers decide whether and how to implement it.

Inter-institutional power play

The law now under consideration bears little resemblance to the draft published in 2008. The directive has been in the works for so long that it has seen the election of a new European Parliament in 2009 and the appointment of a new European Commission in 2010.

Perhaps even more significantly, the directive was originally drafted by the Commission’s ‘Enterprise & Industry’ directorate which was then responsible for pharmaceuticals and was widely seen as having a pro-business agenda.

However, in 2010, responsibility for medicines was handed to John Dalli, the new EU Commissioner for Health and Consumers – himself a former Maltese health minister. This shifted the debate towards consumer protection and patient empowerment.

Companies say they want to share fact-based information about products in print and on the internet given the enormous amounts of data and opinion about medicines and diseases already accessible online, some of which is of dubious quality.

Consumer and patient groups argued that any information provided by industry would have to be vetted by independent experts before being put in the public domain and this was one of the aspects of the directive presented to health ministers.

It seems the directive is going nowhere fast as national governments say the need to cut red tape and contain costs for businesses trumps demands for high-quality information on medicines. Paola Testori Coggi, director general of the Commission’s health and consumers arm, said the delay is regrettable but she sees little prospect of an immediate break in the deadlock.

All pain, no gain

Without attempting to judge whether health ministers, MEPs or various arms of the Commission are ‘right’ in their approach to getting this law through, it’s safe to conclude that a huge amount of time and money has been wasted on this mangled legislation – and citizens are none the wiser and no better off.

And people wonder why the EU can’t tackle the ongoing debt crisis…

L’étude, commanditée en 2003 par l’Assemblée générale et présentée  à sa Troisième Commission conclut que « la violence à l’égard des femmes est universelle et se produit dans toutes les sociétés et cultures, mais qu’elle revêt différentes formes et n’est pas vécue de la même manière ». « Les formes de violence auxquelles les femmes sont exposées, ainsi que la manière dont elles en sont victimes, sont souvent façonnées par la convergence de leur statut de femme et d’autres facteurs comme la race, l’origine ethnique, la classe sociale, l’âge, l’orientation sexuelle, le handicap, la nationalité, le statut juridique, la religion et la culture », indique le rapport, qui estime qu’il faut en conséquence « adopter différentes stratégies, tenant compte de ces facteurs ».

Au long de ses 156 pages, le rapport expose que l’élaboration et l’adoption de normes et règles internationales relatives à la lutte contre cette violence ont enregistré des avancées majeures lors des deux décennies écoulées. « Cette réglementation sert de base à l’engagement des États et d’autres parties prenantes, le système des Nations Unies notamment, de s’employer à y mettre un terme. Les États sont ainsi tenus de prévenir de telles actes de violence; d’entamer des poursuites lorsqu’elles se produisent et de punir leurs auteurs; et d’ouvrir des voies de recours et de réparation aux victimes ».

Mais, souligne le document, un décalage inacceptable demeure entre les normes internationales relatives à la violence à l’égard des femmes, d’une part, et la mobilisation concrète de l’audience politique et des moyens pour les appliquer, d’autre part. Parmi les nombreuses recommandations apportées en conclusion du rapport, le Secrétaire général souligne la nécessité de préciser les obligations des États dans les divers contextes où surgit la violence à l’égard des femmes.

Saluant le rapport, la directrice du Fonds des Nations Unies pour la Population (UNFPA), Thoraya Ahmed Obaid, a déploré le fait que « trop de femmes étaient soumises à la violence puis à la honte ».

      -. Etude approfondie  des Nations Unie sur toutes les formes de violences à l’égard des femmes (FR) http://daccess-dds-ny.un.org/doc/UNDOC/GEN/N06/419/75/PDF/N0641975.pdf?OpenElement

(EN) http://daccess-dds-ny.un.org/doc/UNDOC/GEN/N06/419/74/PDF/N0641974.pdf?OpenElement

      -. Conférence de presse de Michelle Bachelet directrice exécutive de ONU-FEMMES à l’occasion du lancement du rapport http://www.un.org/News/fr-press/docs/2011/Conf110706-ONU-Femmes.doc.htm