Can increased transparency lead to trust in the industry?

Rebecca Aris

pharmaphorum

Trust in the pharmaceutical industry is clearly lacking.1 Given that trust in pharma contributes hugely to public health, this is a highly important area that needs to be addressed. One way to help build trust is by increasing transparency in the industry. A straw poll at the recent Strategic MedComms Forum 2011: Trust and Transparency – Myth and Reality event indicated that the majority of the audience believed that transparency would indeed lead to trust.

This article highlights some of the hot topics discussed at the MedComms event and areas where increased transparency would be welcomed. So, what steps can we take in order to increase transparency in the industry?

“It was claimed that pharma companies had targeted journals to publish positive things about their drug…”

Transparency in pharma involvement in publications

The issue of publication planning has been highlighted recently in the news.2 It was claimed that pharma companies had targeted journals to publish positive things about their drug, which was labelled in one American news bulletin, ‘beyond criminal’. It was also claimed that ghost writers were paid £1000s of pounds for their involvement.

Figure 1 article from Guardian on publication planning2

Whether you believe these claims or not, the end result is a large degree of mistrust towards pharma. However, research shows that ghostwriting is in decline and moved toward disclosure of medical writing assistance between 2005-2008 – a follow up study is due later this year to see if the trend continues.3

There appears to therefore be a discrepancy between how much ghostwriting actually occurs versus how much people believe it to occur. In addition, it is unclear whether there is a disconnect between the number of papers published that actually involve a ghostwriter versus those that are picked up on as definitively being ghostwritten.

But if we agree ghostwriting is causing problems, then who should be responsible for helping to eliminate it?

From the viewpoint of those involved in writing articles, difficulties currently arise in stipulations between guidelines. For example, the ICMJE and the FDAAA have different guidelines for data disclosure, which could highlight a need for a systematic review of good practice guidelines.4

“There appears to therefore be a discrepancy between how much ghostwriting actually occurs versus how much people believe it to occur…”

A suggested practical guide for authors was published in 2009 and provides a step in the right direction towards tackling the problem from the author’s involvement.5 In addition, the release of the best practice guidelines does offer a solution to acting ethically when publishing.6

Figure 2: Table of checklist for authors using medical writers: a practical tool to discourage ghostwriting5

But aside from the journal author, what role should the journal editor play? Should journal staff hold more accountability in spotting articles that have involved ghostwriters?

Editors do have a responsibility to retract seriously flawed articles from their journals, but there appears to be little consistency in journals’ policies or procedures for this. Of articles that are retracted, one paper found that ‘Publications retracted because of misconduct rarely involved declared medical writers or declared pharmaceutical industry support. Increased attention should focus on factors that are associated with misconduct retractions.’7

The greater concerns of the journal editor is geared towards plagiarism, falsification, the results of the peer review process and also whether patient privacy has been adhered to, indicating that perhaps more training is required in this area. Whilst journal staff are currently asking authors to disclose any financial involvement, perhaps a more direct question around medical writer / financial involvement may afford a more honest response.

So the answer here appears to be a combination of a more concerted effort on the behalf of journal staff to identify articles with ghost writer involvement, a stricter adherence to guidelines for authors on the part of the author and a stricter review of guidelines. Finally, the public needs to see more visible evidence of ghostwriting decline in order to garner more trust in the industry.

“…there is no code of conduct that states that publication bias equates to research fraud.”

Transparency in sharing data

Another focus of the event was the topic of withheld data. A negative view of pharma usually follows the unearthing of unpublished data and yet it seems no-one is responsible for monitoring and unearthing such data.

Ben Goldacre, a well-known journalist advocating more open clinical data and regular columnist for the Guardian with his Bad Science blog, raised the example of reboxetine, an SSRI that was recently found to be an ‘ineffective and potentially harmful antidepressant’, according to an article in the BMJ.8 The published evidence in this area was found to be ‘affected by publication bias, underlining the urgent need for mandatory publication of trial data.’8

Approximately 74% of clinical trial data in this instance was not published and yet there is no code of conduct that states that publication bias equates to research fraud. Perhaps there is a lesson to be learnt here around developing such a code?

The problem, as Ben sees it, is that pharma is not proactively getting all clinical data published, good and bad,as quickly as possible. He postulates that as long as data is withheld the public won’t place their trust in pharma, which begs the question – why is the data not being published?9 Is it the submission or the publication which causes the bottleneck and how can this bottleneck be relieved?

In the US, the FDA Amendments Act (FDAAA) 2007 makes it compulsory for the main results of regulated clinical trials to be made publicly available.10 Furthermore, the FDAAA 2008 Act requires that applicable clinical trials be registered in ClinicalTrials.gov no later than 21 days after the first subject in a clinical trial is enrolled.11 However it was argued at the meeting that some clinical trials are omitted from clinicalTrials.gov or appear later than the designated 21 days.

GlaxoSmithKline have certainly taken a step in the right direction by making available in the public domain its ‘Public disclosure of clinical records’.12 This is useful to not only offer a glimpse into their operating procedures but also to monitor them. With such a publically available guide it’s easy to hold the company accountable when it hasn’t adhered to its own policy.

“…as long as data is withheld the public won’t place their trust pharma…”

The lesson from this discussion was that the key to achieving transparency appears to be hosing out data. But how will this work logistically. And is it more effective that we adopt this policy moving forwards as opposed to publishing retrospective data?

Moving towards transparency

The topics discussed at this meeting highlighted a real need for increased transparency to gain the public trust, particularly in the area around disclosure of pharma involvement on published papers, and increased efforts towards making all clinical data publically available so that the no-one can feel that something is being hidden from them.

Whether data can be published retrospectively and whether this would impact on practicing habits or significantly change guidelines from cost-containment bodies such as NICE remains to be seen. However, what was clearly apparent was the need for more companies to post their publication policies on their website – there’s been quite a debate recently about why they don’t already?

Overall, what emerged very strongly from the meeting was the willingness of individuals to drive campaigns to get all data published. With a collective drive in this area we can hope for a future with a more transparent pharma industry, supported by some well-earned public trust.

References:

1. Oil, Pharmaceutical, Health Insurance, and Tobacco Top The List Of Industries That People Think Should Be More Regulated http://www.harrisinteractive.com/NewsRoom/HarrisPolls/tabid/447/mid/1508/articleId/648/ctl/ReadCustom%20Default/Default.aspx.

2. http://www.guardian.co.uk/science/2011/may/20/drug-companies-ghost-writing-journalism

3. Jacobs A, Hamilton A. Decreased evidence of ghostwriting in a 2008 vs 2005 survey of medical writers. The Write Stuff 2009,18(2):118-123. Available online at http://www.emwa.org/JournalArticles/JA_V18_I2_Jacobs1.pdf.

4. Laurence Hirsch Trial registration and results disclosure: impact of US legislation on sponsors, investigators, and medical journal editors 2008, Vol. 24, No. 6 , Pages 1683-1689 http://informahealthcare.com/doi/full/10.1185/03007990802114849.

5. Gøtzsche PC, Kassirer JP, Woolley KL, Wager E, Jacobs A, Gertel A, Hamilton C. What should be done to tackle ghostwriting in the medical literature? PLoS Med. 2009 Feb 3,6(2):e23.

6. Elizabeth Wager, Elizabeth Field, Leni Grossman Good publication practice for pharmaceutical companies Current Medical Research and Opinion 19(3) 194-54 2003 http://www.controlled-trials.com/news/Good_Publication_Practice_for_pharmaceutical_companies_2355-Article.pdf.

7. Woolley KL, Lew RA, Stretton S. Lack of involvement of medical writers and the pharmaceutical industry in publications retracted for misconduct: a systematic, controlled, retrospective study. Curr Med Res Opin. 2011 Jun,27(6):1175-82. Epub 2011 Apr 7. http://www.ncbi.nlm.nih.gov/pubmed/21473670.

8. Eyding D, Lelgemann M, Grouven U, Härter M, Kromp M, Kaiser T, Kerekes MF, Gerken M, Wieseler B. Reboxetine for acute treatment of major depression: systematic review and meta-analysis of published and unpublished placebo and selective serotonin reuptake inhibitor controlled trials. BMJ. 2010 Oct 12,341:c4737. doi: 10.1136/bmj.c4737.

9. Parekh-Bhurke S, Kwok CS, Pang C, Hooper L, Loke YK, Ryder JJ, Sutton AJ, Hing CB, Harvey I, Song F. Uptake of methods to deal with publication bias in systematic reviews has increased over time, but there is still much scope for improvement. J Clin Epidemiol. 2011 Apr,64(4):349-57.

10. FDA amendment act 2007:- http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/ucm095442.htm.

11. FDAAA for NIH Grantees: The Basics http://grants.nih.gov/clinicaltrials_fdaaa/the-basics.htm.

12. GSK’s public policy http://www.gsk.com/policies/GSK-on-disclosure-of-clinical-trial-information.pdf.

About the authors:

Rebecca Aris is Managing Editor of pharmaphorum, the dynamic online information and discussion portal for the pharmaceutical industry. For queries she can be reached through the site contact form or via Twitter @Rebecca_Aris.

What steps can we take in order to improve pharma transparency?