During its quarterly earnings conference call, St.Jude’s CEO Dan Sparks was drawn to speak on the subject of the company’s RESPECT PFO study, which it is hoped will provide definitive evidence for or against the use of PFO closure devices (in this study St.Jude’s Amplatzer) in prevention of cryptogenic stroke. Following Mr Sparks’ disclosure that the results were looking “favourable” there has been significant coverage, not least in Forbes (here), suggesting a whiff of impropriety in the company offering such hints ahead of publication.
We last covered the RESPECT study in January when St.Jude announced that it had completed enrollment and would expect publication later in 2012, the thought being this would be at October’s TCT 2012 meeting in Miami, which remains the case.
Clearly there’s lots at stake, the “opportunity” being a potential market estimated by some at $500M per annum in US alone (the device is already is commercial use in Europe).
So why the furore about Mr Sparks letting slip his interpretation of the state of play? Well, it’s more than adequately covered in the Forbes article, but the fundamental point being made is that the clinical data should really be reported by the investigators at the appropriate time, and that by releasing positive hints now the markets may respond positively, so driving up the share price, when the history of other similar situations suggests that company interpretations are often more positive than subsequent clinical conclusions justify.
St.Jude issued a retort to the Forbes piece almost immediately, which seemed to be saying that Mr Sparks’ use of the word “favourable” was directed more at the study than at the conclusions, although it did hint that the outcome would be better than prior studies because of factors including the device.
On the subject of the company’s access to the data, now being so-called “unblinded”, the retort said this was inevitably the case as the data was being used to prepare its PMA submission, which was always part of the plan.
So what should we think about all this shenanigans? Much as it may look like a storm in a teacup, it’s all pretty important from a patient and financial viewpoint. Healthcare expenditure on PFO closure is far from being insignificant and if it turns out the trial suggests lukewarm supportive evidence, European clinicians and healthcare providers alike will have a new factor to consider if one of the main motivators for performing the procedure is watered down. If this study suggests PFO occlusion remains an “unproven device therapy” as was hinted at by the author of a previous study, how could we poor Europeans justify performing it?
On the other hand, surely Mr Sparks would not have used the “f” word if St.Jude’s first scan of the data had been less than positive.