SprayShield - Approval Status, Clinical Trials, Reasons for Delay & Patient Post - from Dr. David Wiseman

From: IAS Admin (tracy.joslin@adhesions.org)
Thu May 31 08:00:39 2012

Finally an answer- Annie's message about SprayShield (see editorial note afterwards about SprayShield status)

(Annie has asked us to post the following message:)

Had adhesiolysis done with Dr. Jens Pagels in 2010. There was an initial adhesiolysis done with Sprayshield, and Covidien the pharmaceutical maker was present. Four weeks later a second look was done and there was no indication of any adhesions, Covidien was also present. Prior to this adhesiolysis, I had an operation done in the U.S. with no barriers, and an unnecessary resection also done, because the sigmoid was kinked with adhesions, and I had difficulty defecating.

Had I gone to Germany originally, none of this would have happened. The adhesions would have been removed and Sprayshield applied. It would appear that two years later I still have no internal adhesions, because after a colonoscopy, the GI MD. stated that the colon behaved as a normal colon, not one that was adhered in any way.

Surgery is cheaper in Germany, but your insurance may not pay. I can substantiate that Dr. Jens Pagels is the ONLY surgeon I would use. Sprayshield is not available here. Covidien has chosen to market it only in Europe. It is very easy to have surgery done by Dr. Pagels. St. Joseph Moers, where he is chief of gynecology is not far from Dusseldorf, and I am quite sure he would even arrange for transportation to and from the airport. I had a ruptured teratoma (dermoid cyst) in 1965, but was unable to get the colon freed up totally If you want more information these are the ways you can reach Dr. Pagels, of course, email is the most easiest way:

Dr. Jens Pagels, Chefarzt Frauenklinik St. Josef Krankenhaus Moers, Asbergerstr. 4, Moers 47441, Germany

<mailto:gyn.pagels@st-josef-moers.de> gyn.pagels@st-josef-moers.de

Tel: 0049 2841 107 2430

My email address is: <mailto:Mhaya0902@gmail.com> Mhaya0902@gmail.com if you need more information I believe he also has a website on the internet.

Anne Hayashi

Editor's note:

SprayShield: Approval status, clinical trials, reasons for delay, patient posts

Maker not seeking FDA approval. European clinical study planned. Patient Action

It is nice to hear this good news from Annie Hayashi who has certainly suffered many years. Annie was one of the first members of the IAS. If memory serves me correctly she organized our first IAS meeting in San Francisco around 1998.

We have been asked about Sprayshield many times and because of the voluminous and confusing chatter it is appropriate for us to clarify the situation. Patients have told us they have heard from "reliable sources" the "reasons" why Sprayshield is not approved in the US. These "reasons" include:

a. The FDA is making hurdles impossible for Covidien, the makers of SprayShield, to pay for the clinical data needed to get it approved here and holding up the approval of Sprayshield.

b. The makers of Sprayshield tried to get the product approved right after some barrier that caused infections and had been approved by FDA had been removed from the market and FDA were making things harder for that to happen again.

c. There is a conspiracy to destroy Covidien and the doctors who use its products (according to this version it seems that in various ways FDA, the Big Pharmaceutical Companies and even the IAS are involved !!)

So let's try to straighten this out and summarize what we know to the best of our knowledge. Following this summary is a more comprehensive discussion that includes SprayShield's history, available information on SprayShield, how to be treated with SprayShield, FDA approval of adhesions products and the how the Intergel and Adcon stories have affected SprayShield and other adhesions products.

1. Covidien has made a business decision not to seek FDA approval. Covidien has told us that it are neither seeking FDA approval nor conducting further clinical studies with SprayShield. This is a business decision as it views SprayShield, even in Europe, as a low business priority. Covidien has indicated that it would not be able to assist in obtaining "Compassionate Use" exemptions for severe cases in the USA. I personally wish this situation were otherwise, but it is Covidien's decision to make. And so for the moment do not "wait" for any FDA approval. The company, as it has told us, has decided not to pursue it.

2. SprayShield's safety and effectiveness The little information available would likely not be sufficient for FDA to draw any conclusions (one way or the other) about SprayShield's safety and effectiveness. In response to our request, Covidien has undertaken to provide additional information that we can post, which we will do when we receive it. Countries in Europe and elsewhere do not require testing as extensive as that required in the USA, but according to the standards of the countries in which SprayShield is marketed, the product is regarded as safe and effective.

3. A number of factors contributed to the delay until now of SprayShield in the USA likely related to business decisions made by Confluent to focus its efforts in other areas, the need to reformulate SprayGel, the acquisition of original company by Tyco, poor clinical trail recruitment and reluctance of investors to invest in adhesions research because of misperceptions about the adhesions market (estimated currently at about $250 million) stemming from the market withdrawals of Intergel and Adcon.

4. FDA's treatment of SprayShield appears to be no different from that of other products. There is no evidence of any diabolical conspiracy on the part of FDA, Big Drug Companies or the IAS to harm SprayShield or anyone associated with it.

5. Rumors Harm Patients. Perpetuating unsubstantiated rumors about the "reasons" for SprayShield's delay is harmful to patients as it fuels the flames of a fire that says "don't invest in adhesions". We have seen companies (with products with excellent prospects) fail to obtain investment in adhesions research because of similar kinds of rumors that reach the ears of would-be investors. No investment in adhesions (in any company) means no new products. No new products means very little hope to an end in patient suffering. If you see others doing this, ask them to stop and get the facts for everyone's sake.

6. Medical Treatment Abroad is one of many options patients are encouraged to explore for treatment, but only after thoroughly weighing all the available data (or lack thereof), benefits and risks with their doctor and checking the training and experience of the foreign providers. We are happy to post information about doctors and treatments around the work to the extent that they provide patients more options to explore, but in a way that tries to allow patients to make informed and objective decisions about those treatments.

7. Doctors are encouraged to collect and publish their data in the peer-reviewed medical literature so that patients and other doctors can evaluate it objectively. With good data a new treatment will be adopted by doctors so that hundreds of thousands of patients can receive the help that they need.

8. You may be able to join a clinical trial that will study the effect of SprayShield and adhesiolysis on pain. Depending on the data, all patients will eventually be offered treatment with SprayShield. To proceed, more study centers and patients will be needed. The IAS is assisting the planners by publicizing information about the study to other possible study centers in Europe as well as potential patients. If you are interested in traveling to Finland or another European country to participate in the study, please let me know by email: david.wiseman@adhesions.org.

This summary as well as a more detailed version, can be found at:

http:// <http://www.adhesions.org/WisemanSprayshieldUpdate052412.pdf> http://www.adhesions.org/WisemanSprayshieldUpdate052412.pdf,

Enter keywords:
Returns per screen: Require all keywords: