The TAVI Registry, journey to the UK and other news


London Bridge, at night.

Just returned from a quick trip to London, UK to interview a couple of fantastic thoracic surgeons. (You can read the interview here.)

In the meantime, a midst multiple conflicting reports regarding the use and safety of TAVI (percutaneous aortic valve replacement) the ACC and STS have finally come together to create a TAVI registry, similar to the PCI and cardiac surgery registries.  The new registry will be used to track TAVI procedures and outcomes.  Hopefully, by gathering information in a standardized fashion and collecting data on patient outcomes, we can finally answer the essential question surrounding TAVI: Is It Safe?

As someone who is intimately involved in the STS database – I can assure readers that if STS is involved, data collection will be extensive, cumbersome and overly complicated.  (The adult cardiac surgery data collection form is fourteen pages long.)  However, the database will allow doctors to identify whether complications are device related/ procedure related or operator related.  (For example, are post-procedural strokes caused by the valve (device related) itself, or by the person (operator related) inserting it?  It will also track 30 day mortality – and the causes of mortality.  (ie. Was the death coincidental versus bleeding/ stroke/ kidney failure, etc?)  The registry will also track one year outcomes – but unfortunately – the essential question  – Is it Safe long-term?  will remain unanswered.

In Big Pharma news – I had the good fortune to meet (and talk to at length) one of the inside investigators* for GlaxoSmithKline.  He was a delightful and charming interview – and it was a fascinating inside look at the future of pharmacology, pharmacy, drug development and marketing.

As readers know – I have vilified and railed against pharmaceutical companies in the past (and most likely – will continue to do so) but it was an excellent opportunity to see the other side of a blighted industry.  [Here at Cartagena Surgery – I may have unabashedly strong opinions, but I do try to be fair.]

As an investigator for a pharmaceutical company, his position is somewhat akin to George Clooney’s character in the recent film ‘Up in the Air’.  He investigates company employees as well as independent contractors who represent the company for moral, ethical and criminal violations.   In the wake of several serious recent ethical and criminal investigations into the pharmaceutical industry in recent years – companies such as GSK take this duty extremely seriously.  As part of this effort – they hired people like the man I am interviewing today.  Mr. X is surprisingly charming, amiable, and witty.  Somehow as a ‘trigger man’ for a big company, and former NYC police officer, the gentleness, and the compassion emanating from him is unexpected.   He tells me that he has received thank you letters from people who were ‘separated from the company’ on his say-so – and I am not surprised.

We talk about public and health care providers perceptions of the pharmaceutical industry, and trends of the past.  We discuss the previous ‘bribe and gift’ atmosphere of the past – and he gently calls me out for my Pfizer bag from a long-ago conference.  [Ironically, I’ve railed against this bag in the past – it’s from a conference I attended as a student, but hypocrite that I am – have neglected to throw it out.  In my own weak defense – I will say that I never again have accepted or received ‘sponsored’ gifts or items.]  But he’s right – and I accept my scolding, hopefully with the grace it was given.

He talks about one of the new projects that GSK is implementing – and I immediately sit up and take notice.  Phasing out the ‘hootie girls’ as we call the often scantily clad, inappropriately dressed, invariable young, attractive (and always! well-endowed) pharmaceutical representatives that cold call doctors offices with girlish laughs, lots of legs and sample supplies of costly drugs.   No, I will not be sad to see the end of the ‘hootie girls’.

Replacing the hootie girls will be nurse educators.  Instead of pushing costly brand name drugs – they will be restricted from mentioning brand specific medications.. But educate they will.  Hopefully these educators will serve as a resource for healthcare providers – to assist us and inform us without trying influence us.  In many ways – it sounds like GSK may be moving in the direction that we need to go.. Afterall – with millions of millions of people needing treatment (and the vast amount of disease out there)  just obtaining and supplying these patients with the medications they need is a phenomenal effort – and companies can still make a HUGE profit on volume alone.    (And I am not against making a profit – it supports drug research etc..)

But the idea of being able to use the vast amount of information collected from these companies and their volumes of research without rancor, or hardcore skepticism – is encouraging.  If we can build bridges and trust – we can ultimately better serve our patients.. Of course, nothing this big ever goes off without a hitch, and Rome wasn’t build in a day – but it’s a start.. 

It’s a hopeful view from an unlikely source at the end of a very long day that started in one country and ends in another..

* I didn’t get a chance to ask his permission to  write about our meeting – so in fairness, I have omitted his name.

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