Several recent stories have caught the industry’s attention and set media imaginations alight, but none moreso than last week’s record-breaking US$3B marketing settlement between pharma giant GlaxoSmithKline and the US government. In short, GSK plead guilty to withholding safety data and illegal marketing practices related to three drugs and agreed to pay US$1B in criminal fines and US$2B to resolve civil complaints with the federal and several state governments.
The Financial Times responded to the GSK news by branding the industry as ‘unethical’ and called for greater transparency and scrutiny; particularly of industry-doctor relationships (you can read the piece with a subscription here). For some time we’ve been publicly discussing the role of illegal marketing, highlighting around 12 months ago the then record US$2.3B settlement Pfizer paid for activities similar to GSK’s. The practice has continued to grab the media spotlight as companies scramble to respond to the drying up of product pipelines and the ongoing demands of shareholders for increasing returns in difficult markets.
It has been clear that dramatic reforms were needed in our sector, and that the marketing and distribution of drugs required novel eyes, a different approach. Within Clinuvel this topic has been one of much debate in recent years, and a review of the pharmaceutical axis – company, insurers, prescribing physicians, and patients – has taken place in the context of the specific therapeutic area in which our teams operate. In summary, the driving factors for successful development of SCENESSE® have been the patients first, and physicians second. Due to our specific fields of focus, namely dermatology and gastro-enterology (with regards erythropoietic protoporphyria, or EPP), and due to the nature of the disorder the demand for treatment has been very much driven by patients’ experiences following drug administration.
Since 2006 Clinuvel has been working with the EPP community, a unique group of individuals (Recently I discussed the development of this program and I encourage you to read this piece, if you haven’t already). Having met EPP patients around the world it has become obvious to me that this disorder poses a severe burden on the existence of these patients and their families.
In the world of unlimited communication and social media, it became apparent in 2007 that patients’ perceived benefits of SCENESSE® as a newly introduced treatment, as well as possible side effects, would be best reported by patients themselves. Therefore, the company openly took the position that patients’ demand would largely determine the company’s decision to continue clinical trials and distribution, or to discontinue the development. In our case a remarkable shift in the pharmaceutical axis took place from physicians to patients, whereby positive clinical experiences became widely known through media channels, social media and Twitter and became key to our clinical program. Responding to patients’ experiences, we altered clinical trial protocols, discussed the patients’ needs and tailored the therapy regimen to the future use of the product: year round photoprotection.
By working closely with insurers, patients and absorbing the physicians views on ‘medical need’ and best clinical utility, Clinuvel secured early on a dialogue whereby the patient ultimately – in the case of porphyria – strongly made their experiences known to us, sponsor of the clinical trials.
In this particular program, we needed to return to the core value of delivering drugs and new solutions for patients. It’s complex, time consuming, costly and – at times – an incredibly frustrating endeavor. Yet, if successful, it can also be a journey of great satisfaction for all involved.