Tag Archives: Regulation

Solar radiation and its implications

The Sunshine Act is sending ripples across the MedComms profession, both in the US, where it applies, and elsewhere. While the medical profession and pharmaceutical clients assess their responsibilities and develop their own responses to the legislation, here’s a very brief summary of the new requirements:

  • Enacted to enforce public disclosure of financial relationships between the pharmaceutical industry and medical professionals
  • Requires annual reporting of payments, or ‘transfers of value’ provided to physicians or teaching hospitals (first reporting date March 2014; ‘Transfer of value’ includes medical communications services)
  • Applicable to any company that operates or markets a compound within the US, and to any interactions with US medical professionals regardless of location

(adapted from ISMPP Sunshine Act Task Force)

Undoubtedly, addressing perceived or actual conflicts of interest within medicine is timely and appropriate. In complex environments, however, it’s not until such policies have been road-tested that all of their consequences start to become apparent.

At the 6th Publication Plan meeting in London, supported by Adis Journals and organised through MedComms Networking, these consequences were explored by a roomful of medical publications professionals. Liz Wager (Publications Consultant, Sideview) gave an excellent and comprehensive presentation of the guidance and legislation concerned, both old and new.

One main point of discussion was exactly how MedComms services are interpreted as ‘transfer of value’ (TOV) under the Sunshine Act. In general, if medical professionals are required to declare medical writing, editing or analytical assistance personally as TOV, it could have a real impact on their willingness to accept such assistance. This could in turn reduce the number and quality of publications they are prepared to author, as the perception of such payments will be less positive than, for example, research funding.  ISMPP state that ‘payments for medical research writing and/or publication would be included in the research payment, if the activity was included in the written agreement or research protocol’, but this is not always done, and it can be challenging to estimate the amount required accurately. The worst-case outcome could be fewer papers and less thorough reporting of studies, contradicting the drive for greater transparency.

An recent update from ISMPP suggests two interpretations of TOV in relation to assistance with medical publications.  One proposal is to divide the TOV equally between authors (such that having more authors would minimise the impact on each author’s balance sheet!). However, dividing TOV equally between authors could be contentious given differences in contribution, and international authors would be exempt.  There’s a further grey area concerning the TOV represented by specific services, for instance, a primary publication. Industry averages exist, but there’s no list of ‘fair market values’ as proposed by ISMPP as an alternative option. Whether this will turn out to be workable is not yet clear.

As other nations begin to draft and adopt similar legislation, as has already occurred in France,  it will pose a challenge to the pharmaceutical industry to ensure that all regulatory requirements are met. Get in touch with Peter Llewellyn and the MedComms Network to get involved in the discussion and communicate with others involved in medical publications.

Just for fun – a guidelines map!

There’s a confusing plethora of reporting guidelines out there, so here’s an explorer’s map to help navigate them! Tell me please if there are any I’ve missed or misplaced…


As a brief note of explanation, the ‘states’ are the main areas to which guidelines apply, and ‘cities’ are those guidelines which fit neatly into a particular area. Some guidelines or bodies are more broadly encompassing and these are written across the map. Finally, the ‘invaders’, AllTrials and RIAT (links), represent the push towards transparency in reporting clinical trials. Most of these are listed and explained on the EQUATOR network (links)

(If you would like to use this, or better still make a proper version with graphics software, do get in touch!)

Digital media’s impact on trial recruitment and expanded access

I was pleased to be able to take part in a recent Twitter Q&A on patients and digital media. John Pugh, Digital Innovation Team Leader at BI, and Dave Pinnington , Digital Lead at Pfizer, which was coordinated by Eye for Pharma. I asked how the advent of digital media would affect trial recruitment and design, now that patients, and indeed health care providers, can access detailed information on trials and new treatments. I was particularly interested in the implications for expanded access programmes, for patients for whom Phase III results will be too late.

Digital media’s impact on trial recruitment within the specified indication can certainly be seen in the popularity of Patients Like Me and other initiatives. As for trial design, the impact of increased numbers of informed patients is ‘inevitable’, according to Pugh. However, Pfizer’s REMOTE trial, designed to evaluate an overactive bladder drug and conducted entirely online, was recently halted due to a lack of participants. While disappointed, Pfizer for one aren’t abandoning the concept of virtual trials just yet. REMOTE also generated useful experience in terms of regulatory approval and data capture.

Expanded access is now the preferred term for the use of investigational drugs in patients who have exhausted all other treatment options, and who do not necessarily meet all of the inclusion criteria for ongoing trials. It’s less equivocal and certainly less emotive than ‘compassionate use’, but both will be found in use. However, the implementation of such programmes is less streamlined. A survey conducted in 2010 by ECRIN found discrepancies in the regulation and interpretation of expanded access between different countries. More recently (May 2013), the FDA released draft guidelines for industry on expanded access, which are currently under review. It would seem sensible for companies to adopt an expanded access policy as part of the design and protocol of clinical trials, particularly at the Phase III level.

Despite these advances, an unfortunate example of how not to handle expanded access featured in the Twitter feed. Biomarin’s treatment of Andrea Sloan, who requested access to an experimental drug for ovarian cancer, is beyond any parody of bad Pharma. The absence of any concrete policy, coupled with the painful leaked emails from the CEO dismissing Ms Sloan and her supporters, were indicative of an ingrained failure to address expanded access.

Widening participation in expanded access programmes seems likely as companies come under increased pressure from informed patients. To quote Pugh and Pinnington – ‘any business ignoring the expectations of customers is doomed’, and ‘democratisation of information is changing the patient dynamic and how we should engage’.

There are some caveats to this, both procedurally in that expanding access can hamper recruitment to earlier phase studies, and in terms of unknown risks to patients. There may also be risks inherent in switching to a new drug as monotherapy, such as resistance development in HIV. How best to handle the data arising from expanded access, and how to avoid compromising current and future drug development, could be the next topic for discussion.