ملتقى الشفاء الإسلامي - اخير ا اكتشفوا علاج نهائى للصدفية

السلام عليكم ورحمة الله وبركاته ،،،،

بحثت قبل عدة أيام عن سبب عدم اعتماد Kalawalla من FDA والحمد لله أن هداني إلى أحد المواقع الحوارية حول مرض الصدفية حيث يقوم مدير الموقع بالتراسل مع مدير الشركة المصنعة للـ Kalawalla مستفسرا عن سبب عدم اعتماده من قبل FDA وهنا النص الكامل للحوار مع مدير الشركة المصنعة السيد ميندوزا :

President of Organic Hope Writes About Kalawalla
from Jorge Mendoza
Background from Ed:
In early October, FlakeHQ correspondent ZK (from Slovenia) sent me a link to an FDA site she had discovered while searching for “Kalawalla.” The link contained an FDA report of a refused import shipment of Kalawalla by Organic Hope — the manufacturer — intended for its New Jersey shipping facility. This year especially, Kalawalla has been much discussed here at FlakeHQ and this news was disturbing, to say the least. Using the on-line feedback form at www.organichope.com, I sent this message:
I'm the producer of FlakeHQ.com, a web based community for psoriatics founded in 1996. For the past year, your product "Kalawalla" had been much discussed on this site. (Search on "Kalawalla" from the home page to peruse correspondence.) The important point to note is that, so far, all reports from correspondents using Kalawalla have been GOOD.
Today I received a disturbing email from a correspondent in Slovenia with this link http://www.fda.gov/ora/oasis/8/ora_oasis_c_hn.html, which appears to report problems with the FDA.
Can you provide us any reassurances that your product will continue to be available? My next update at FlakeHQ.com is scheduled for November 1st and I would love to post some good news from you. -Ed Dewke
Towit, I received this response....
*****
Dear Ed: Thank you very much for your encouraging e-mail. Our company has been selling Kalawalla in Europe for well over 10 years now and we are only glad to come into the US market through the 1994 DSHEA. Our company is small, none the less, we have been able to sustain a 100% year-to-year growth for the past 6 years due to the quality of our Kalawalla products.
In Europe and in other countries such as Australia and New Zealand (sold as Difur and Leucostat), our product is a well recognized immuno-modulator (not immune suppressor), and through its Th1/Th2 modulating abilities, it is able to help about 80% of all psoriasis patients within 12 weeks of use, and when the period of use is extended to 6-12 months, the success rate is dramatically increased (this data is based on Organic Hope patient/customer feedback). Fortunately, very few side effects are reported through the use of Kalawalla world wide.
Kindly find a few research papers on the following links that support our product. All are published materials in well known journals and by reputable organizations such as the Harvard School of Medicine.

http://www.organichope.com/english/harvardtrial.htm
http://www.organichope.com/english/kalawalla_trials.htm

I can gladly provide more research for you upon request.
With regards to the FDA rejection of product, kindly note that this rejection was performed upon my request. Two shipments of Kalawalla were detained in August en route from our manufacturing facility abroad to our shipping facility in New Jersey. The detention was based on three issues:
1. The label had a different order for the listing of carbs, proteins, fat, etc. from that required by the FDA.
2. The label had www.organichope.com written in large print (which may read ¨Organic Hope¨ and, according to the FDA, may mislead customers to think the product is hope for a cure).
3. The label did not contain the common name for Polypodium leucotomos extract, which is Calaguala (not the phonetical brand Kalawalla).
The FDA had no issue with regards to the *******s of the product or claims made under the 1994 DSHEA. The FDA gave us two options, ship the product to New Jersey to change the label and have an FDA inspector (paid by Organic Hope) inspect the new labels or, reject the product from import and have it shipped back to our manufacturing facility for re-labeling. I myself decided to have our product rejected from import and re-labeled at our manufacturing facility, as this was more economical than having to subcontract someone in New Jersey for re-labeling and pay for an FDA inspector to re-inspect the shipments.
Our company then rapidly corrected these issues taking the following action:
1. A summarized Supplement Fact panel detailing carbs, etc. was placed on the label.
2. The reading www.organichope.com was removed from the new label.
3. The term Calaguala is now in place in large bold type.
Once these issues were corrected, subsequent shipments have been made to the USA starting in mid-September without any new FDA detentions. We are still about 10 days backed up on our orders but we expect to be up-to-date on our deliveries within the next week. Most wholesale distributors have received their orders on-time.
Kalawalla can be found through wholesale distributors in the USA as Kalawalla, Bielavin and Immunotrax and can also be purchased directly from our web site. Kalawalla is shipped from our New Jersey dispatch centre.
We do not expect to have any further issues with the FDA and we sincerely apologize to any patient if they feel our label was misleading (as stated by the FDA). We do not claim to have a cure for psoriasis, but only a safe, natural treatment that can help patients manage their psoriasis for prolonged periods of time without any side effects (and at affordable prices).
Kindly let me know if there is anything else I can do for you. Or if there is any further information you would be requesting, I would more than gladly provide it for you. I have searched and used your web site many times in the past and I believe you are one of those web sites that provide not only an excellent service to the community but a necessary one to keep the community well informed based on fact. Please keep up the good work and consider us as a friend. Yours truly, -Jorge Mendoza, President, Organic Hope
*****
Ed’s Response: I encourage readers to go to the first link Mr. Mendoza supplied, which contains extracts from a Harvard study of PLE (Polypodium leucotomos, the fern from which “Kalawalla” is extracted). My eyes widened when I read about the inhibiting effects on “cytokines showing a Th1 pattern (IL-2, IFN-gamma and TNF-alpha).” I’m always nervous trying to interpret science, but it begs mention that the inhibition of some TNF is what some of our current biologics claim to do. Can the two be compared? Not by me! But I will also note (because I noted it) that a year on any of the current biologics costs $12-$15,000 and Kalawalla supplements can be purchased for about $500 per year in the U.S., direct from Organic Hope (click here for their online terms).
Some readers will remember a remarkable email exchange with Ron K., who lives in Honduras, earlier this year — Kalawalla Straight From the Source. The PLE fern grows wild in Honduras and Ron learned how to harvest it for a topical application on his lesions:
“Does it work! In six days the spots were almost gone and in a full 2 weeks they were only a figment of my memory. When the spots begin to return, I get the plant and do the treatment for a day or so and all is well again for another few months.” -Ron K.
I couldn’t help but smile when I read this in the excerpts from the Harvard study:

“. . . we show that, the topical application of PLE to the skin of hairless albino mice (Skh-1) significantly diminished the mast cell infiltrate as well as the number of blood vessels triggered by chronic ultraviolet B (UVB) irradiation.”

Whether or not the Harvard results suggest a reason for Ron’s success, it suggests there is something going on when the plant matter is applied topically to the skin.
This Kalawalla phenomenon just continues to get more interesting! I’m not trying it, yet, because I’m scheduled to try the biologic Humira starting in January — and while my insurance continues to be willing to pay for this stuff, I want to try it. But several FlakeHQ correspondents are using Kalawalla and I implore all of them to keep us informed. -Ed

المصدر :

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ملاحظة : سأقوم بالترجمة في وقت لاحق إن لم يسبقني إليها أحد الأخوة

لكن خلاصة الحديث أن المشكلة مع FDA لم تكن بسبب مكونات الدواء ، وأطمئن الجميع بأن الدواء آمن ولله الحمد.