Re: Digest Number 745

March 12, 2000

To the newer members,

I have been on alpha interferon for almost 14 months. My dosage is 250

units 4 times daily. From the 3rd day on interferon, 70 to 80% of my

symptoms were gone. I still cannot overdo it; however, for a 57 year old

female - I do quite well.

The doctor that originally agreed to prescribe this treatment left the

country. For about 6 months I was only taking half the dose (trying to make

it last) and many of the original symptoms crept back in (not as severe

though). Through the help of Clement (previous list owner who is

also on this) who shared her interferon with me and McFadden (member

also) referring me to a doctor - I am back on my original dosage.

It is taking several weeks for me to get back to my highest level of

improvement. I am close but not quite at my best.

Fondly,

Shari Dodd

Re: (unknown)

>

>Any advice on how to find a doc. My doc is okay, but i haven't needed any

help with my cfids until just recently, and I'm afraid she may not believe

me. we haven't talked about cfids, except that i did at one point tell her

i had been diagnosed with it, but i was doing well.

>

>melanie

> FM oral IFN alpha study a confusing report & mixed results

>

>Low Doses Of Oral IFN-Alpha Offers Some Relief In Fibromyalgia

>

>(From Doctor's Guide to the Internet)

>

>AMARILLO, TX -- March 10, 2000 -- A just-completed Phase II clinical

>study conducted by Amarillo Biosciences, Inc., has

>shown promising results for sufferers of fibromyalgia syndrome.

>Fibromyalgia is a syndrome characterized by achy pain and

>stiffness in the soft tissues, including the muscles, tendons and

>ligaments. The three-month study, involving 89 patients at four

>clinical sites around the United States, was designed to measure the

>effectiveness of low doses of orally administered

>interferon-alpha (IFN alpha) in relieving morning stiffness of joints, a

>significant problem for fibromyalgia sufferers.

>

>The double-blinded, placebo-controlled test was the second in a series

>of trials that, if successful, would lead to U.S. Food &

>Drug Administration (FDA) approval of the new treatment regimen.

>Patients participating in the study were divided into three

>groups, and each individual was given three lozenges per day. The three

>lozenges given to members of the first group contained

>50 international units (IU) of IFN alpha each, while the second group

>was given one 50 IU IFN alpha lozenge and two

>placebos. Members of the final group received three placebos. All three

>groups reported a reduction in morning stiffness, but

>across the entire study, the improvement was most pronounced in those

>taking one 50 IU lozenge of IFN alpha per day.

>However, the result did not reach statistical significance relative to

>the controls, nor did increasing the dosage to three IFN

>alpha lozenges per day improve the results.

>

>All 89 participants were also given a low dose of the anti-depressant

>drug, amitriptyline, which they began taking one month

>prior to the start of the IFN alpha trial and continued throughout the

>three-month study. Dr. Philip C. Fox, Director of Research

>and Development for Amarillo Biosciences, said addition of the

>amitriptyline was deemed necessary so the patients would not

>have to tolerate a four-month period without therapy. However, he also

>noted that use of the amitriptyline complicated the

>analysis and interpretation of the study results.

>

> " In an effort to isolate the effects of the amitriptyline on the

>stiffness results, we looked at the responses of patients during the

>first month of the study, when they were receiving only amitriptyline, "

>said Dr. Fox. " Patients who did not worsen during the first

>month's treatment with amitriptyline went on to demonstrate a

>significant reduction in morning stiffness (p=0.0035) when they

>took the 50-IU IFN alpha lozenges once a day for three months compared

>with a placebo. However, those patients who

>reported worsening of their morning stiffness during the first month

>showed no benefit during the subsequent three months of

>IFN alpha treatment. "

>

>The reduction in morning stiffness found in this study was consistent

>with results from an earlier six-week blinded trial except

>this test showed a more positive response in the placebo-treated group.

>(Note: It is well documented in such studies that

>patients taking placebos tend to report at least some improvement even

>though they are receiving no active drug.) Interestingly,

>though, this " placebo effect " varied significantly from site to site. At

>one of the four locations, for example, 20 patients were

>treated and those receiving one 150 IU lozenge per day reported results

>consistent with one-a-day groups throughout the

>study. However, placebo patients at this same site noted only minimal

>improvement relative to those at the other sites.

>

>Fox also said that the search for relief for fibromyalgia sufferers,

>estimated to number between 4 million and 7 million in the

>U.S. alone, is important because current therapeutic options are

>inadequate and no medication has been specifically approved

>by the FDA for treatment. Rheumatologists typically prescribe pain

>relievers, sleeping aids, anti-depressants and exercise for

>patients with the syndrome.

>

> " Fibromyalgia syndrome has a significant impact on the quality of life

>and the productivity of patients, and thus represents a

>large market with unmet needs, " said Dr. ph Cummins, President and

>CEO of Amarillo Biosciences. " However, this is the

>second study in which we have seen benefit from a 50-IU IFN alpha

>lozenge given once daily in relief of morning stiffness. "

>

>Like Dr. Fox, Dr. Cummins noted that the robust placebo response in the

>most recent clinical trial was a concern, but said

>future studies will be designed to allow for this effect and the effects

>of concomitant medications (such as amitriptyline).

>Amarillo Biosciences' COO Kathleen Kelleher agreed, saying, " Prior to

>commencing further clinical trials, we will consult with a

>group of expert clinicians and opinion leaders in fibromyalgia syndrome

>research to review the results of our studies to date and

>to assist us in designing our future trials. "

>

>Amarillo Biosciences, founded in 1984, is a pioneer in the development

>of low dose orally-administered interferon-alpha as a

>treatment for a variety of conditions including Sjogren's syndrome,

>fibromyalgia syndrome, Behcet's disease, hepatitis B and

>opportunistic infections in patients who are HIV positive. ABI is

>conducting a Phase III clinical program in Sjogren's syndrome

>in the United States and has already enrolled over 450 of the targeted

>500 subjects in pivotal trials. The company is targeting an

>initial filing for regulatory approval in Sjogren's syndrome by the end

>of this year.

>

>___________________________________________________________________________

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>___________________________________________________________________________

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>

November 8, 2000

Barbara- Thank you- yes, it is Kathleen Norris- I know she's busy, but hopefully

she'll have room for one more.

Tamar

November 8, 2000

Tamar,

She has literally saved my son's life. She is the best!!!! She is busy, I

book my appointments for him 3 months in advance....but you can get in...I

did. Kathleen just had surgery and my son hasn't seen her for three weeks.

I hope that I can hold on for one more week. Keaton, my son, also has

trich, along with ADHD, anxiety and OCD. He has hair now, hasn't pulled

since he's seen Kathleen. I think she's a miracle worker! As is stated in

my post, she is in Bedford, so that won't be that big of a drive from

Dallas. Bedford is kind of on the outskirts of Tarrant County. I drive

from southwest Fort Worth, about 45 minutes. Kathleen is well worth the

drive.

Have a great day.

Barbara

-

November 8, 2000