[Click on the following for Link to External Article]
http://www.medpagetoday.com/Gastroenterology/GERD/14401
What is Barret's Esophagus?
Here is a simple and easy-to-follow web page on the disease:
http://digestive.niddk.nih.gov/ddiseases/pubs/barretts/
The esophagus has a sphincter which should technically allow passage of food (bolus) from the mouth to the stomach and prevent the motion backwards. Gastro-esophageal reflux (GER) is a condition where the sphincter stays open longer. This allows the acid from the stomach to rise, and causes heart burns, the ability to taste food near the back of the mouth etc.
When this condition happens more frequently, like more than 2 times a week, it is called GERD, a more serious condition, now qualified as Gastro-esophageal Reflux Disease.
In about 20% of people who have GERD, the lining of the esophagus, typically muscular, is now replaced with lining from the stomach. This is when the disease becomes Barret's Esophagus.
Barret's Esophagus and Dyslpasia
In a very small percentage of patients with Barret's Esophagus, (less than 1% according to the reference above), develop a rare form of cancer called esophageal adenocarcinoma. Carcinomas are cancers of tissue linings and walls.
Before this happens though, the tissue develops pre-cancerous cells leading to a tissue condition called dysplasia. As a result, regular biopsies are recommended. Usually though, the disease is noticed in later stages, and treatments are not very effective at that point. There is no indication that the current radiofrequency ablation technique would help those patients either.
Barrx Medical and their treatment
Barrx was started sometime in the year 2000 and has made this product commercially available since 2005. However, it looks like this particular study shows a lot of promise for the device.
Analyzing the study
Please read the Medpage article at the beginning of the blog for specific details. I want to discuss the key points of interest here:
1. The study was not the world's best - still, producing great results. The high-grade and low-grade nature of dysplasia in the patients randomized to be treated as opposed to the sham treatment was somewhat unnecessary. This is the first large trial with the device/treatment modality. Nothing significant can be gained from splitting patients up. It could have waited for a second study, and yes I know, they are expensive. They could have still noted down the grades and sought some sort of meaning. Right now, we don't really know of a big difference the treatment has on the grades. Plus, it only makes it harder for the device's reimbursement strategy, which I guess is not short of an uphill task.
2. The second point is somewhat moot, but worth a throw - we still need to wait for long term follow up.
3. The treatment was not a large scale energy wash - in patients that were randomized to be treated, dsyplasic and metaplasic (irregular, but not fully differentiated) lesions alone were treated. That is this was not a "paint" type of ablation procedure delivered over a large region.
I like the idea of a localized treatment. However, there is the confounding factor - do we know we got everything? In a preventive treatment setting, wouldn't being more conservative indicate higher value? This of course, needs to be balanced with factors such as anticipated side-effects.
3. As reported by the researchers themselves, the results are on somewhat of a fragile trend, at least right now. Of the patients that were treated, if one more patient had developed cancer or if one less person in the sham procedure group had not developed cancer, things would have been very different.
Of course the striking thing is, unlike our friendly, neighborhood stent trials, researchers and companies, this word came from the researchers themselves.
4. This treatment could definitely become first-in-line for patients with dysplasic or metaplasic Barret's.
5. What of course, would be the state with patients who have early stages of the disease?
This of course, is where the commercial challenges lie.
Will the physician community accept this as a reasonable preventive measure and recommend it?
Will the same significance persist in a larger patient population with longer follow up?
Will insurance reimbursement come through, especially for patients with the early stages of the disease?
What about the competition from medical management and others trying to play in this device/therapy space?
6. The most important thing helping anyone playing in the Colon cancer space for example, tends to be the large scale motivation for biopsies. How about Barret's and GERD? Will routine biopsy be recommended given the small percentage of folks developing cancer? If they do become routine, then Barrx will be in a great position. If not, no harm done, except there will be some missed opportunities in the white space.
Conclusion
Of course, challenges always lie ahead, but right now, things are looking good for Barrx and the treatment. Time will have to tell if everything that exists will hold and other things that are necessary will fall into place.
If the company continues to play it right, they could win over surgeons, reimbursement and find themselves on line for a good chunk of change.
The Post Script (P.S.) - Radiofrequency Ablation
Radiofrequency Ablation is a tired old horse that has been beaten to death quite a bit. Dozens of companies out there have done to radiofrequency what has been done to stents. Given a chance people would try stenting for everything from migraines to mania. In a similar fashion, for every conceivable disease radiofrequency/energy based destruction, albeit in many cases, without much attention being paid to rhyme, reason or scientific thought. It is one thing when when Google throws sphagetti on the wall, it is another when people try that with disease conditions.
Of course, the point there is that if some company X tried an energy delivery modality and failed, it doesn't mean much. At least, it does not always mean they failed for the right reasons, as has been demonstrated by several third-in-class, fourth-in-class devices and so on.
Based on the study's results, it is not too presumptuous to note that Barrx may at least be on the right path...
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