Dr. Wiseman speaks with Dr. Moore

From: Dr. David Wiseman (david.wiseman@medispecialty.com)
Thu Jan 16 18:47:03 2003


I have just spent the best part of an hour on the phone with the now (in)famous!! Dr. Moore, who kindly accepted my invitation to give me a call. In my conversation Dr. Moore came across as a caring physican, concerned for his patients. He is anxious to learn as much about adhesions as possible in order to help his patients. He had some excellent questions about the whole field which I was able to answer. He made a number of good observations which I share with him, and I fully believe that he will be keeping in touch with me to discuss the field so he can do more for his patients.

Dr. Moore expressed to me how sorry he was to have created such a stir and that he would be bowing out gracefully (or not as the case may be) from the message board.

Anyway for the record let's keep this board doing what it is good at - providing support for the many isolate and confused victims of ARD. If technical type issues come up, please refer them to me (as was done in this case, but Dr. Moore and I were not able to speak until today).

This is probably a good time to address some important issues about medical products in general and how they get approved in different countries.

In Europe and many other parts of the world, a product can be approved for sale on the strength of animal experiments alone. In the USA however, in most cases, the FDA requires that scientifically conducted clinical trials are performed in humans. There is good reason for this since the FDA has a duty to protect the public health, and until a scientific clinical study demonstrates that a product is safe and also works, the product cannot be sold. Even then, problems may arise once it is used in thousands of patients, as opposed to just the few hundred that participate in the clinical trial.

FDA aside, the GOLD standard by which we judge a product is the "double blind, randomised, controlled clinical study". Until we have such data, it is difficult to make any real conclusions about the product.

Very often we receive reports of clinical studies in their early stages, say with 20-30 patients or so. These may certainly provide encouragement, (as is the case for example with Spraygel) but it would be premature to conclude definitively that a product works until the study is complete. These reports may provide enough encouragement for some people to try that product, if their condition is bad enough that it is worth the risk. For example we have had a number of patients visit doctors in Europe in order to have INTERGEL, or Spraygel, products that are, or were not approved in the USA, at the time.

For patients suffering with severe ARD (Adhesion Related Disease) there is an understandable desire to try the latest product under investigation. Many people have volunyteerd for clincial trials. It is your right to do so. But PLEASE remember that until we have had the results of properly conducted clinical studies, we cannot draw any conclusion about the product. INTERGEL, INTERCEED and Seprafilm all have good points, but none of them is perfect. Spraygel and ADEPT show good promise but we do not have large enough clinical studies to make good judgements yet. Furthemore, many of these products are tested in patients that do not have the severe form of ARD (there are good reasons for this, which I am not going to explain now), but we hope that sooner or later such tests will be performed.

NO MATTER HOW PROMISING A NEW PRODUCT SOUNDS, NO MATTER WHAT YOU HEAR ABOUT IT FROM OTHER PATIENTS, PLEASE REMEMBER THAT NOTHING IS FOOLPROOF. THE PRODUCT MAY NOT WORK IN EVERYONE, INCLUDING YOU.

At the same time we must encourage and applaud all the companies (eg J&J, Genzyme, Confluent, ML etc.) who do this type of difficult and expensive work, becuase it adds to the body of knowledge about adhesions and it increases awareness.

The same should be said about doctors. Even the best doctor, with the best techniques will produce adhesions. They do not have magic wands, and the most we can hope for is a doctor who will take the time to learn as much about the problem as possible and to apply that knowledge help his patients. Please let's encourage the medical community to ask these questions and let's try to educate them. I thank all of you for your efforts in this regard. Let's keep fighting!!

Sincerely David Wiseman Founder, International Adhesions Society (IAS) http://www.adhesions.org david.wiseman@adhesions.org


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