Any of us that have been following the Cellestis story for any length of time are fully aware (and probably at times frustrated) that the evidence is clearly available that QuantiFERON-TB Gold provides a superior diagnostic method for TB infection with enormous benefits for TB control, patients and society, yet the uptake to date has been only modest. I guess it is easy to come up with all sorts of pejorative reasons why this is so, but if we really want to find the reasons we need to more closely examine the controlling factors and dynamics of the market.
TB disease has been with the human race for thousands of years and has been seriously managed by the medical profession for over one hundred years. Much has been achieved in those 100 years - we now have a reasonable understanding of TB, we have diagnostics for TB and we have treatments for TB. None of this is perfect but it is at least something. It's a positive that we have made this progress. However, with that positive comes some negatives.
Cellestis have a stated aim of "Changing the way the world looks at TB". That's a huge undertaking.
Let's look at a different situation. What are the dynamics when a previously unknown disease strikes? We don't even need to guess at how this is dealt with. In recent decades there have been a number of such events that have been managed with greater or lesser success, HIV, bird flu, H1N1. When these diseases strike, we (the human race) start with a blank slate and apply our not insubstantial resources to understanding the disease and developing diagnostic and treatment protocols. In the first instance our answers may be imperfect but each answer is usually better than the last and over a relatively short period of time we become better at dealing with the disease. Everybody understands and accepts this process. Everybody from the most elite research scientists through to the "coal face" practitioners accepts the dynamism of that situation and adopts improved practices very rapidly.
TB is different purely because it has such a long medical history. In that time a huge amount of research has been performed and practices have become entrenched. These practices have worked, to the extent that the human race has not been wiped out by TB. These practices have become enshrined in legislation, guidelines and in the knowledge of TB practitioners. Very few practitioners are going to step outside that structure. That is both understandable and wise.
To change that situation is a long and arduous task. Many common perceptions need to be challenged. Our medical system, that is rightly designed to protect us, requires huge amounts of real evidence before it changes. In the specific field (in this case TB diagnostics) the new findings must be justified against all previous findings - often this is a case of actually integrating the new knowledge into the old in a logical and correct manner. The new knowledge may not only extend upon previous knowledge but also explain previously unexplained data. It may even refute previous understandings or assumptions. Every step of this course must be negotiated in the correct academic and medical way. At first glance, to laymen like myself it seems incredibly tedious and long winded. It may even be that in some instances it is. However the challenges in changing that whole system to one which can progress more quickly but still provides the required protections would make the challenge of implementing a new TB diagnostic seem minuscule in comparison.
In short, it seems to me that Cellestis had no choice but to embark upon this road some ten years ago (back in the days when I was sprightly youngster with no grey hairs). That is why, no doubt, they embarked upon the much discussed "top down" approach to this. That is, allowing and assisting the researchers to investigate the diagnostic to their own satisfaction, then gaining legislative approval (FDA) and finally the medical authority stamp of approval (CDC). Of course it is not quite as clear cut and sequential as the above might imply but you get the idea. It is only when all of that is in place can you really commence the actual aggressive selling of QuantiFERON-TB Gold into the market with the level of success that is inevitable.
We are almost there!
Cellestis have done an amazing job of negotiating this path while, at the same time, husbanding their quite modest financial resources and, even more amazingly, making enough sales to turn a respectable profit.
In my opinion the new CDC guidelines that will be released "very shortly" are the last major piece of the puzzle. If what Dr. Masae Kawamura has presented is indeed correct (and there is no reason to believe it is not - it is backed up by other sources) then all the significant shackles to sales success (in the USA - the rest of the world to follow) have been removed.
In simple terms, it seems that the new CDC guidelines allow the use of QuantiFERON as the TB diagnostic in every single situation that you might want to diagnose TB. The one and only caution is that they retain a preference that children under 5 year old be tested with TST. No doubt as more trial results become available, even this will be changed.
More importantly (according to Dr Kawamura), the QFT diagnostic is preferred in what amounts to the majority of testing scenarios. (I will personally be interested to see if the guidelines make any specific reference to HCW testing)
We are not at the end of the road. We are now just approaching "the end of the beginning". With the release of this guideline, Cellestis will be able to implement a powerful sales push directly to the absolute market coal face. It is going to be an exciting time.
Addendum: Make sure that you read this over here on Rogs Blog.
No comments:
Post a Comment