The HAI Europe office would like to thank all the speakers, moderators and participants at the "Clinical Trials on Trial" Open Seminar, held in Berlin on Friday 21 November 2008. We were very happy to attract such a high turnout, with over 80 participants on the day.

The three panels, discussing clinical trials (CT) design, ethics, and the use of clinical trials as marketing tools successfully highlighted the urgent questions that need addressing in order for CT to be a reliable and valuable method for assessing the effectiveness and safety of new pharmaceutical products.

Clinical trials are considered the 'gold standard' for scientific research and the most reliable tool to obtain evidence on a medicine's effectiveness. But, just how much do we know about the way they are designed, conducted and presented?

Seminar pack featuring the programme, speaker bios, abstracts, and other background materials

Participants list

Keynote address

Peter Lurie:

Joel Lexchin: Moderator
Anita Hardon: Diversity in CT, design, Institutional changes
Joan-Ramon Laporte: Disclosure, Access, Selective data, Impact on safety

Christian Wagner-Ahlfs: Moderator
Wim Vandevelde: The Patient Perspective
Annelies den Boer: CT in Developing Countries

Elina Hemminki: Moderator
Trudy Dehue*: Clinical Trials as Marketing Tools
Petra Jonvallen: Case study on CT

* The author of this presentation is awaiting the publication of an accompanying article. Both the article and the presentation will be available in due course. Please see the abstract in the Seminar pack for more information.

European consumers are overwhelmed with health information. But, how much of it is actually useful and developed with their needs in mind? Much of the information currently circulating is incomplete, biased or simply wrong.

As societies become more interconnected and technologically advanced, sharing information across borders has become a common phenomenon. Yet, serious efforts to check the quality of this information or restrict its distribution are limited by many factors.

In October 2007, expert speakers and participants at the HAI Europe Open seminar tackled the issues of Patient Information and Direct-to-Consumer-Advertising (DTCA) of prescription-only medicines. Click here for the full seminar report

The infiltration of pharmaceutical marketing into the world of healthcare practitioners and medical science has been put front and centre by publications such as the British Medical Journal (BMJ) (http://www.bmj.com/cgi/content/full/336/7658/1402). A number of recent articles in the BMJ have given well-deserved attention to the issue of medicine promotion and the controversial strategies employed by drug companies, and in particular, the use of key opinion leaders (KOLs).

The most damaging aspect of the KOL trend is the intrinsic conflict between the interests of pharmaceutical companies’ marketing departments and the interests of patients. As the middle men in this relationship, doctors and medical researchers hold a position of inviolable trust. Treading the fine line between duties to patient health and duties as a KOL in the pay of a pharmaceutical company will inevitably place a strain on a physician’s independence. It would be naïve to assume that success as a KOL for the pharmaceutical industry does not divide loyalties between profession and pay cheque. Pharmaceutical companies would not, and could not afford to continue employing experts who failed to achieve their marketing objectives.

As a minimum, more stringent transparency regulations for KOLs would provide a clearer picture of the conflicts of interest and allow other doctors and medical scientists to make informed judgments about the credibility of their message. However, transparency is no substitute for independence. Highly paid KOLs in a long-term relationship with a pharmaceutical company are more likely deliver information that has passed through the dubious filter of the company’s marketing department than they are to present reliable comparative data. Clearly, this represents a real obstacle to informed decision-making by patients and doctors alike.

The influence wielded by KOLs creates a distorted picture of therapeutic value and worse still, helps to extend the reach of that distortion to those responsible for public health and well-being. To counter the influence of KOLs and measure the real value of a medicine, we need independent voices to discuss new medicines in context, side-by-side with other available treatments and with the fullest possible appreciation of its benefits and potential risks.

A return to independence and integrity must be championed and underpinned by unambiguous regulations to govern interaction between business and medicine. Drawing a line between the market and the research will ensure that the interests of public health trump the interests of the pharmaceutical industry.

This article is also available at http://www.bmj.com/cgi/eletters/336/7658/1402#197879.

With the European Commission’s consultation on ‘patient information’ – or advertising by any other name – nearing its conclusion, and the possibility of a legislative proposal to introduce DTCA looming, what is happening elsewhere?

In Canada, a major media company, CanWest MediaWorks is suing the federal government, claiming that the law prohibiting DTCA infringes on its freedom of expression. This case has serious ramifications beyond Canada’s borders. The case is not about editorial content for this media company. CanWest is seeking access to part of the massive flow of money spent by drug companies for DTCA—money that ultimately adds to what consumers and patients pay for medicines. The litigation pits a national law intended to prohibit DTCA against corporate "freedom of expression" to allow drug companies to advertise. 

This case reflects just how lucrative pharmaceutical advertising has become. In the US last year, spending on prescription drug ads was US $5.4 billion (3.4 billion euros) second only to automotives among consumer product advertising.

The expert testimony for this case has all been posted on the web:
http://www.whp-apsf.ca/en/index.html

Witnesses for the government and for a public interest coalition of unions and non-profit groups that have obtained standing in court have amassed a wealth of evidence on the serious potential for harm from DTCA. The Canadian government is arguing that the law is necessary for protection of public health. This is based primarily on the US research evidence on content and effects of DTCA (Joel Lexchin, Michael Wilkes), and on the problematic advertising experience to date (Gurprit Kindra, Garry McCarron).

DTCA has a potent role as a cost driver without health benefits, threatening sustainability of public health care financing (Steve Morgan). Prohibition of DTCA is a regulatory norm internationally, albeit one which is under threat in many jurisdictions (Graham Dukes). The Canadian government is already under siege, with advertisers repeatedly ignoring the federal government’s attempt to stop illegal campaigns (Ann Sztuke-Fournier); opening up the country to DTCA would just compound the problem.

John Abramson, representing the public interest coalition, raises concerns about specific harm to women from DTCA. Additionally, his testimony points to the strong links between negative effects of pharmaceutical promotion on medicine and DTCA. Jean Belleville points out that by leading to rapid increases in drug costs, DTCA poses a massive risk to workers’ health benefit plans.

Additionally, you will find ‘reply’ testimony that challenges CanWest’s arguments that DTCA has health benefits. David Butler-Jones is Canada’s chief public health officer. He argues that we should not rely on drug companies for public health campaigns; governments can do a better job.

Should pharmaceutical companies enjoy greater legal freedoms to provide prescription drug information directly to the public in line with new EU proposals?

What is your opinion? We invite you to answer the BMJ poll online and to vote for NO at http://www.bmj.com/#poll
An article by Tessa Richards in the British Medical Journal calls upon readers to “grasp the opportunity to respond to a controversial EU proposal to allow drug companies to provide information on prescription only drugs directly to the public”.
Read all about it here

Amsterdam, January 18 - HAI Europe welcomes the investigation launched into the pharmaceuticals sector by the DG Competition of the European Commission. On the 16th of January antitrust regulators raided several of the largest pharmaceutical companies in Europe.

This investigation is a response of the Commission to indications that competition in the European pharmaceuticals market is not working well: lack of innovative medicines being brought into the market, and delays in the registration and commercialization of generics. The inquiry will investigate the factors contributing to the current situation.

The commission suspects that the companies in question, either by misusing patent rights or recurring to vexatious litigation and other means, have made it extremely difficult for other generic manufacturers to enter the European market.

HAI Europe welcomes the move taken by the Commission in defending consumer and patient rights and hopes that the results of the enquiry will lead towards ensuring equitable access to essential medicines within the European Region.

At a recent HAI Europe Open Seminar , ‘Ensuring Independent Medicines Information in Europe’, a representative of the European Federation of Pharmaceutical Industries’ Associations (EFPIA) Dr. Scott Ratzan said that his organization would be interested in revisiting Article 88 of Directive 2001/83/EC, which regulates the advertising of prescription drugs in Europe. At the same event, Christian Siebert, Head of the Pharmaceuticals Unit of the European Commission remained silent when asked by an audience member whether a proposal for legislative change was pending or being planned.

In spite of being overwhelmingly rejected by the European Parliament in 2002, it is now confirmed that the pharmaceutical industry wants legislative change to allow them to advertise medicines directly to consumers. Moreover, it is willing to use the current debate on patient ‘information’ to initiate change.

The Seminar, of HAI members and stakeholders, included representatives from patient organisations, medicines regulators, health care professionals, the European Commission and the European Pharmaceutical Industry. The program focused on the need for information on medicines that is independent of any influence of the pharmaceutical industry and the inherent conflicts of interest that implies. With notable exceptions, speakers and participants condemned moves to reopen the direct-to-consumer advertising debate in Europe and were critical of public private partnerships which allowed commercial interests to influence the provision of information.

Make no mistake - under the guise of ‘patient information’, the direct delivery of promotional information by the pharmaceutical industry is being discussed in Europe, and the pharmaceutical industry want discussions to extend to legislative change. EU citizens need reliable, unbiased, comparative and tailored information on medicines, and will not benefit from drug advertising masqueraded as information provision. 

For all the Open Seminar presentations, click here

Pharma TV - Diagnosis: advertising

Find out more here.