I think my ear is purple from being on hold and I am quite dizzy from the "run-around".
That being said, I am still awaiting calls from the CEO of Carrington Labs and from the FDA. I contacted the USDA and talked to the main office, USDA-Veterinary Services, USDA-APHIS (Animal and Plant Health Investigative Services), USDA-Animal Care, and finally a member of the senior staff at USDA-APHIS, Dr. Davis. Dr. Davis was very helpful and he has worked in this office for many years. He tells me that injectible Acemannan falls outside the jurisdiction of the USDA. They handle vaccines - but no other veterinary medicines. He checked his resources and said that this drug was approved by the FDA and that it would fall under their jurisdiction.
I asked Dr. Davis if the USDA removed products from commerce while conducting audits. He told me that he has never heard of that happening in all his years working for the USDA.
After my conversation with Dr. Davis, I called Dr. Nicholson at Veterinary Products Laboratories and told her what I had learned from the USDA. I asked her if they had documentation that informed them of the audit and if she could check that for me and verify the initiator of the audit. She told me that this information was passed down to them from Carrington Labs. I asked Dr. Nicholson if she thought it would be helpful for me to write my congressman. She told me that a lot of people were doing that and it could only help.
Meanwhile, we wait to talk to the FDA and Carrington Labs (or rather, the appropriate office for redirection of blame).
Stay tuned for another episode in the continuing saga...
Elizabeth
*Save the earth. It's the only planet with chocolate.*
-----Original Message-----
From: [EMAIL PROTECTED]
To: felvtalk@felineleukemia.org
Sent: Thu, 26 Oct 2006 1:09 PM
Subject: Re: Acemannan availability
Dr. Nicholson at Veterinary Laboratories returned my call a moment ago. The organization responsible for this audit is the USDA. She gave me some contact numbers there and I am going to do my very best to be professional when I express to the USDA my displeasure with knowing that there are cats whose lives may have depended on this product while they took their time doing their audit. Dr. Nicholson told me this one man who is in charge of the veterinary division may not even know about this but I assured her that he would after I spoke to him.
The mixture used in the injectible Acemannan (pronounced like it sounds - "Ace manan") is proprietary and so there is no generic and they have people from over seas calling everyday trying to get the product. Right now, it simply isn't available. Dr. Nicholson did not know why Acemannan Hydrogel is not subjected to the audit when it contains the same raw ingredients. There is another lab right now that has an audit going on but the product being audited is not currently withheld from commerce. The USDA has some questions to answer.
Meanwhile, I asked Dr. Nicholson if there was a human equivalent to Acemannan. She told me that Manapol Plus (by Carrington Labs) is used for people. It is taken orally rather than as an injection. She was not sure if this product had been studied for use in cats but she thought it may have been.
I asked her if the USDA had given any indication of how long this audit would last - and she told me that the last she heard, they hoped to be through in November.
What I want to know is what gives the USDA the right to remove a proprietary product from the market that has been proven to save cat's lives? Even if lives weren't at stake - what gives them the right to shut down this company's bottom line? What if this were the only product they made? This goes against everything our system stands for and I refuse to sit passively while this happens. I'm wondering if I need to write my congressman.
Kiss the kitties for me,
elizabeth
*Save the earth. It's the only planet with chocolate.*
-----Original Message-----
From: [EMAIL PROTECTED]
To: felvtalk@felineleukemia.org
Sent: Thu, 26 Oct 2006 11:47 AM
Subject: Re: Acemannan availability
Elizabeth, Thanks for doing this!!! That is awesome of you to take time to find out what's going on. You are helping out so many others by doing this-that's why I like you! :) Wendy --- [EMAIL PROTECTED] wrote: > I've been on the phone this morning with Veterinary > Products Laboratories. They were unable to answer > my questions but say they will have someone call me. > I also left a message for the CEO of Carrington > Labs (without a great deal of hope that they will > return my call). I did my best to be friendly and > professional...here is a list of my questions (and > general talking points): > > I understand that the injectable form of veterinary > Acemannan is being withheld from the market due to > an audit of this product. As a member of the > felineleukemia.org mailing list, I would like to ask > you some questions. We have no commercial interests > and only want to give our pets the best possible > life. Many of us have very sick cats with feline > leukemia and would very much like to purchase your > product. > > 1) What organization is responsible for the > unavailability of this product? Do you have the > name of a contact person for this organization? > > 2) When was this audit instigated? > > 3) It was my understanding that this is a > routine audit – yet this audit has been going on > for well over a month. This is the first I have > heard of a routine audit that prohibits people who > need the drug from purchasing it for such a long > period of time. How often does this happen and are > there any other products which might suddenly become > unavailable for long periods of time? > > 4) I notice that wound dressings containing > Acemannan Hydrogel are still available on the market > – how is it that the non-injectable form of the > product is not affected by the audit? > > 5) Is this product available outside the US? > > 6) Is it possible to purchase the raw materials > and formulate Acemannan for injection for personal > use only? > > 7) Where can I go for more information? > > Thank you for your time. > > I don't know where to go from here. I'm thinking of > contacting the FDA and asking them which > organization instigated this audit and ask where I > can go for more information. If I find out anything > further, I will let you all know. > > elizabeth > > > > -----Original Message----- > From: [EMAIL PROTECTED] > To: felvtalk@felineleukemia.org > Sent: Thu, 26 Oct 2006 6:26 AM > Subject: Re: Acemannan availability > > > Soon after they first began to withhold this product > from the market, I called Veterinary Products Lab. > (Hideyo found out about this initially when she was > trying to buy the product). It was still available > on their site then too. That's when they told me > about the audit. At that time I searched for > restrictions and found nothing as well. They said > this kind of audit was routine but I find that hard > to believe since it has been withheld for so long. > > elizabeth > > > In a message dated 10/26/2006 6:12:37 A.M. Central > Daylight Time, [EMAIL PROTECTED] writes: > http://www.vpl.com/product.php?catmain=&mainkey=&pid=80&key=8&cat=Wound%20Management > > so the injectible is still on their current webpage, > for what that's worth! > > On 10/26/06, Paolo <genr[EMAIL PROTECTED]> wrote: > > I dug in my old Emails about ACEMANNAN (please > note the double N in the > > spelling, if you use a search engine ACEMANAN > won't work), and in effects > > once I contacted Carrington Labs, and they > redirected me to Veterinary > > Products Laboratories (VPL, http://www.vpl.com), > that unfortunately I > > could not contact at that time because their mail > server kept bouncing > > back my emails. > > From the info in my possession, injected Acemannan > works great with a > > number of *localized* (i.e. not spread) tumors. > Carrington Labs, at that > > time, did not mention any FDA restriction. > > > > Good luck > > Paolo > > > > > > > -- > Spay & Neuter Your Neighbors! > Maybe That'll Make The Difference.... > > MaryChristine > > AIM / YAHOO: TenHouseCats > MSN: [EMAIL PROTECTED] > ICQ: 289856892 > > > > ________________________________________________________________________ > Check out the new AOL. Most comprehensive set of > free safety and security tools, free access to > millions of high-quality videos from across the web, > free AOL Mail and more. > __________________________________________________ Do You Yahoo!? Tired of spam? Yahoo! Mail has the best spam protection around http://mail.yahoo.com
