George Bernard Shaw once said, "Beware of false knowledge; it is more dangerous than ignorance."
Last year, the Ethical Standards in Health and Life Sciences Group (ESHLSG), published its best-practices guide surrounding the issue of clinical trials data. The ESHLSG is a consortium of healthcare professionals and representatives from the pharmaceutical industry whose charter is to focus on practices that will increase the quality of patient care.
The need for best-practices is clear. There have been cries of "foul" from all sectors of the world marketplace amid the controversy surrounding Avandia and Avastin safety and efficacy issues. At the core of the debate is the reality that only a small percentage of the clinical trials performed on approved drugs are ever published for access by the healthcare community.
Failed trials or abandoned indications are never released. The rationale behind the ESHLSG position is that these trials can provide valuable insight into the effectiveness of new, approved drug therapies to healthcare professionals.
But now, the battle for formalizing clinical trial transparency is heating up in the European Union. 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. Specifically, the lead legislator wants full clinical studies, not simply their summaries, to be submitted and therefore be available for disclosure.
In her view, company data can be protected in line with existing measures. This initiative raises some interesting issues for the industry, not just in Europe but for any company contemplating filing in the European market.
The truth about drug development, whether it is a New Molecular Entity (NME) or a generic drug therapy, is that there are many clinical wrong turns during the drug development lifecycle. Often, it is these missteps that help define the final indications and product requirement specifications.
The British Pharmaceutical Industry issued a statement supporting the initiative, which raises a number of implementation concerns. First, most drug development programs contain hundreds if not thousands of pages of information. The practical reality of reviewing and redacting all information that could have patient privacy implications is overwhelming.
Second, most clinical reports are written for clinical and regulatory audiences, not for commercial and healthcare providers, and contain confidential information. It is not unusual to include the development strategy for future studies. In some cases, companies may consider that a particular study design is a trade secret that competitors could learn from. Furthermore, study reports often include appendices with detailed information on analytical methods (chemical and physical) and on the manufacturing of the clinical trials material.
And what about generic drug companies? The frequency with which they successfully demonstrate bioequivalence right of out of the gate is very low. What will happen to the generic drug development rate when the consideration is that all missteps must be published fully?
Lastly, including the entire clinical file will make it much easier for competitors to develop competitive products. I spend a lot of time in Asia working with companies who have a central business strategy of launching into the EU. What will this do to their ability to innovate and develop products for these markets?
While there are few who would disagree that transparency is a good thing, the risks of a poorly implemented plan can have repercussions across the entire global pharmaceutical marketplace. Perhaps a better quote would be "Be careful of what you wish for; you may just get it."