MS Helping Hands - MSHH

Health & Safety Education

 

Click here: Index to Drug-Specific Information

The 10 Steps of Having MS

People with MS are always interested in knowing what the most common

symptoms of MS are, so here is a list of them:


COMMON SYMPTOMS OF MS:
* Extreme weakness or fatigue,

*Being sensitive to heat,
* Loss of coordination,
* Staggering or loss of balance,
* Stumbling – falling,
* Dragging of one or both feet, (sometimes referred to as drop-foot)
* Tremors in hands, arms, legs,
and/or head,
* Twitching in various parts of body
or head,
* Prickling sensations in body parts,
* Numbness in hands, feet
& possibly other body parts,
* Headaches,
* Loss of eyesight, double or blurred vision,
* Involuntary movement of eyes,
* Twitching of eyes,
* Sharp stabbing pains behind the
Eyes,
* Speech difficulties, slurring,
stuttering and repetitive speech,
* Memory loss,
* Bladder and/or bowel incontinence,
* Pain in various parts of the body,
* Tightness in abdominal area,
feels like tight bands around waist,
* Impotent, (ED), Sexual Dysfunction,
* Mood swings, (Bi-polar functions)
* Appearance of being under the
influence of alcohol,

Because there are so many symptoms attributed to Multiple Sclerosis, it is often

very difficult to diagnose. Many other diseases have the same symptoms.

 

MS, a 10-Step Learning Program ……………….

•       Shock, (Out of the blue, all of a sudden you have MS. In most cases you either have never heard of MS nor have any idea what it is. It is not MD, Muscular Dystrophy; you are not one of Jerry’s kids)

•      

                      Anger, (Why me Lord, Why ME? You did nothing that caused you to get MS, nor did your parents even though it can be hereditary)

 

•       Fear, (All the things you won’t be able to do anymore and what will others think of how you are acting? You could easily give the appearance of being under the influence of alcohol)

 

•       Shame/Loss of self-esteem, (Having to depend on others & developing sexual problems – ED – sexual dysfunction. Things you have always taken for granted of being able to do now become next to impossible. Try doing things with your left hand if you are right handed)

 

•       Denial, (Not sharing with others that you have MS, trying to hide the symptoms and how you really feel – If they don’t know what you are dealing – coping with, how can they help you? You are only kidding yourself for not letting others know)

 

•       Sharing, who do you tell? (Other than your spouse, who already knows, your children, parents, siblings, extended family members, friends, boss and if you are the boss, your employees, if not married, your fiancé or girl/boyfriend, people you are dating. As my wife often reminds me, I don’t have MS, We have MS. It is a family disease.

 

•       Bargaining, (For God to make it all go away and you will do whatever he wants you to do)

 

•       Depression, (Withdrawing from society, hiding away, drinking more, taking pills, suicide is not an option – don’t even think about it!)

 

•       Acceptance, (Ok, you have MS, now make the best of it and continue to do what you can still do and don’t dwell on what you can’t)

 

•       Moving On, (Reach out to others and get involved…MS support groups can serve as a resource to learn about and socialize with others who have MS and share how they deal – cope with it)


 

Elaine DeLack - The Prokarin Story

 http://www.insidesuccessradio.com/Guests/Elaine-DeLack


The Cheap, Safe and Effective Treatment for Multiple Sclerosis That the

Drug Companies are Trying to Keep Secret

 

DONOR CLOSET HELPS PEOPLE IN NEED

Click here to see news item

 DC-KOMO-512.wmv

 

Aspartame - What you don't know can hurt you!

Why isn't the FDA protecting your health?

 

PROKARIN CONFUSION

 

THEY SAID IT DIDN'T MAKE "CENTS"

- MS -

THE PROKARIN STORY

IS MS A CASH COW FOR THE MEDICAL FIELD

"THE ORPHAN DRUG LAW"

 

'Cholesterol'

Is the Cholesterol Craze Just Hype?

www.9spot.com/mshhvideo/Chlosterol020306.wmv


________________________________________________________________________________________________

 

                                                          

                                                    
http://www.thisholyinstant.com

 

Aspartame - What you don't know can hurt you -

Why isn't the FDA protecting your health?

  "Aspartame was the most studied additive ever approved by the Food and Drug Administration," argues Martha Stone, Nutrition Advisor and professor at Colorado State University. Stone, an advocate for aspartame, claims that "aspartame wouldn't have gotten to the market if it caused problems in humans" (qtd. In Castrone 12D). Does "most studied" imply safe for human consumption? More importantly, what were the results of these studies and how was aspartame approved? An in depth look at the history of aspartame approval reveals a trail of suspicious methods and possible collusion between the FDA and the G. D. Searle company, manufacturer of aspartame.

 

    Aspartame was discovered in 1965 by a chemist from the Searle company (Farber 53). After researching their product to determine its safety, Searle submitted tests to the FDA for the approval of aspartame. According to The Deadly Deception, compiled by the Aspartame Consumer Safety Network, the FDA approved aspartame in 1974 for limited use based on the tests selected by Searle. After the approval, the FDA learned that some of Searle's other products had serious side effects. Also, a study done by Dr. John Olney, research psychiatrist from the Washington School of Medicine, revealed that holes in the brains of mice appeared after the consumption of aspartic acid, a major ingredient in aspartame. This study was submitted to the FDA after they had already approved aspartame for limited use. This new evidence prompted the FDA to organize an internal Task Force to investigate Searle's original research (7-8).

 

    In their investigation, the FDA 1975 Task Force reviewed a study done for Searle in 1969 by Dr. Harry Waisman, Professor of Pediatrics at the University of Wisconsin. The study involved feeding aspartame mixed with milk to seven infant monkeys. After 300 days, five monkeys had gran mal seizures and one died. Dr. Waisman died before all of his studies were completed. The Task Force uncovered that when Searle had submitted the Waisman study to the FDA, all the negative data had been omitted (The Deadly Deception 6-7).

 

    The Task Force also discovered that questionable lab practices had been performed by researchers from Searle. In a summary of their investigation, the Task Force concluded: We have uncovered serious deficiencies in Searle's integrity in conducting high quality animal research to accurately determine or characterize the toxic potential of its products. . . . The cumulative findings of problems within and across the studies we investigated reveal a pattern of conduct which compromises the scientific integrity of the studies. (Qtd. in The Deadly Deception 8-9).

 

    This investigation revealed that Searle researchers had cut out tumors in animals that had been fed aspartame and neglected to report all of them or check for cancer. Also, animals that were "reported as dead, were later reported alive again" (The Deadly Deception 9).

 

    Other findings of the Task Force included "falsified data" from another Searle product, the Copper 7-IUD, a birth control device. This product had to be pulled off the shelves due to a $9,000,000 lawsuit. Searle lost even though they claimed the IUD was safe (The Deadly Deception 8).

 

    As a result of the findings of the 1975 Task Force, a smaller Task Force was assigned in 1977 to investigate Searle's original research even further. This investigation uncovered that Searle had again falsified data by submitting inaccurate blood tests. Apparently, they had substituted unrelated animal tests because of instrument problems. In another study, a closer look revealed that uterine tumors had developed in some test animals. Searle "admitted" that these tumors were related to the ingestion of a breakdown product of aspartame, Diketopiperazine (The Deadly Deception 10).

 

    Due to the 1977 Task Force findings, FDA ordered a grand jury investigation of Searle's aspartame studies. Assistant U.S. Attorney, William Conlon, and U.S. Attorney, Thomas Sullivan, failed to start any legal action against Searle concerning aspartame testing. Consequently, time ran out and the grand jury investigation terminated. Conlon was then hired by the law firm that represented Searle. It is interesting to note that this was not the first time Searle had been involved in a grand jury investigation. They had been accused of unreported tumors in the testing of their two drugs, Flagyl and Aldactone (The Deadly Deception 10-11).

 

    According to an article in Technology Review, aspartame came up for approval again in 1980. This time the FDA recommended that a Public Board of Inquiry be created to determine aspartame's safety. The Board was composed of three scientists. They "recommended keeping aspartame off the market until further animal tests could show that it did not cause tumors" (Farber 53).

 

    The disapproval of aspartame by the Public Board of Inquiry wasn't enough. The Deadly Deception states that a five member Commissioner's Team of Scientists was then formed to look at the results of the Public Board of Inquiry conclusions. Three scientists voted against approval and two scientists voted for approval. Inexplicably, a sixth member joined the team with a vote of "yes" to the approval of aspartame creating a deadlock. Dr. Goyan, the FDA Commissioner, decided not to approve aspartame at this time (13, 16).

 

    In April of 1981, Dr. Arthur Hayes became the new Commissioner. Searle applied again for approval of aspartame. A few months later, Dr. Hayes approved aspartame for use in dry foods. In 1983, he approved aspartame for use in diet soft drinks (The Deadly Deception 14-15). One month later, Dr. Hayes left the FDA and within three months he was working for Searle's advertising agency, Burson-Marsteller (Farber 53).

 

    Aspartame's history of approval speaks for itself. The Searle company, whose sales were 700 million in 1992 (Therrien 42), had much to gain from the approval of aspartame. After researching their own product, Searle selectively chose the tests and then submitted them to the FDA. How can Searle, the company who stands to profit, determine which reports are to be given to the FDA? An instant bias is created when this is allowed to happen. Even when independent researchers, such as Olney and Waisman, were approached by Searle to conduct safety tests, Searle withheld important information that these researchers had discovered. The Searle company's effort to produce a clear picture on the safety of aspartame is at best a weak attempt. Falsified data, unscientific lab practices, and a history of problems with some of their other products makes it hard to believe that Searle's concern for the public's health takes precedence over financial gains.

 

    The FDA should be the objective source to verify if Searle's research is valid. The FDA has the final approval and the public depends on them to determine the safety of a product. In this particular case, the repeated reviewing of aspartame studies by forming two task forces, a Public Board of Inquiry, and two teams of scientists seems redundant if not suspicious. The research indicating tumors and falsifying of data resurfaced every time. It appears that all of these attempts were to ultimately get aspartame approved, not to determine it's safety. If the FDA had been really concerned, they should have insisted on reviewing all of the original research before it was approved for limited use in 1974. Even if the FDA's repeated attempts to investigate aspartame's safety were legitimate, ultimately, it was Commissioner Hayes' responsibility to determine if this product should enter the market. When he approved aspartame, it was more than questionable if his intentions were sincere. His employment with FDA was just long enough to get aspartame approved and then he conveniently quit and was hired by a Searle related company! How can we rely on the FDA to make the right decisions concerning aspartame approval if we are suspicious of their motives?

 

    How does all this relate to the safety of aspartame? First we must explore what safe means. The FDA defines safe as a "reasonable certainty of no harm" (Farber 48). Searle's evaluation of aspartame's safety was compromised when they withheld negative data and supplied inaccurate test results. Without valid research, "reasonable certainty of no harm" is difficult to determine. How can aspartame be on the market if the FDA and Searle failed to determine whether it was safe or not?

 

    Brain tumors and seizures in aspartame-fed animals indicate a possible risk to humans. The dictionary definition of safe means "not presenting or involving any danger or risk" (Webster's 877). Does this mean aspartame is not safe? The answer lies in the hands of the public. Although aspartame was not tested on humans before its approval, it now has been tested on the public by default. Over 200 million Americans consume aspartame products (Weininger 1/ZZ1). We have been the guinea pigs in the testing of aspartame without even knowing it. A look at aspartame's ingredients and its devastating effects on human beings provide the evidence for avoiding all aspartame products.

 

 ©Copyright 2005 Dr. Joseph Mercola. All Rights Reserved.

    This content may be copied in full, with copyright, contact, creation and information intact, without specific permission, when used only in a not-for-profit format. If any other use is desired, permission in writing from Dr. Mercola is required.

 

Disclaimer: The entire contents of this website are based upon the opinions of Dr. Mercola, unless otherwise noted. Individual articles are based upon the opinions of the respective author, who retains copyright as marked. The information on this website is not intended to replace a one-on-one relationship with a qualified health care professional and is not intended as medical advice. It is intended as a sharing of knowledge and information from the research and experience of Dr. Mercola and his community. Dr. Mercola encourages you to make your own health care decisions based upon your research and in partnership with a qualified health care professional.

 (MSHH comments: You can now buy many of the popular soft drinks using Splenda instead of Aspartame.)

 

PROKARIN CONFUSION

Tuesday, September 27, 2005

Elaine DeLack, RN

     I empathize with each and everyone’s frustrations as I have experienced similar ones myself. Change is always difficult and that added to the changes that accompany MS can create even more frustration. But sometimes changes are necessary despite the challenges the changes pose. I have been using Prokarin for 8 years and like many of you who use Prokarin, I can tell when it is providing me the usual effect and when it is not. And it is when I am not experiencing the usual effects that force me to investigate further. Let me recap what I have found and what prompted so many of the changes you have all endured these past years using Prokarin including these latest changes.

 

    First of all, you must understand that what is seen in a petri dish (in vitro) is not always the same effect seen in the body (in vivo). Hence, most of the drugs that are listed in a Drug Reference state, “Action: Unknown”. This is further complicated in that every medication is a chemical of some sort that gets acted upon by the body and vice-versa and each of us have somewhat different chemical make-ups—genetically as well as from what we have acquired from our environment. These factors coupled with the uncertainty of MS can really create a challenge. Given all of these variables, there is no way I could have developed Prokarin without the grace of God.

 

     Everything I have learned about Prokarin, histamine, caffeine etc has come from my experience of personally using it. It is from these effects of Prokarin that I have witnessed that prompt me to try and find a scientific explanation. In the very beginning, only one pharmacy made Prokarin (Judi Richardson RPh developed the formula for me) and this is the pharmacy I always got my Prokarin from and the same pharmacy that provided the Prokarin for the first feasibility study and the double-blind study. In 1999, we licensed numerous pharmacies to make Prokarin (about 750 total). Dr. Gillson published two clinical studies, one in December 1999 and another in June 2000 of which he stated about a 67% effect was seen from the Prokarin. Whereas the feasibility study done in the first part of 1999 showed an 80% effect. I later learned that the difference might have been in part due to the variation in consistency of the Prokarin from pharmacy to pharmacy. Remember the Prokarin supplied for the feasibility study was provided by only one pharmacy, the pharmacist who developed the formula and who made the Prokarin I used.

    In 2000 I started calling Prokarin users to compile information for a Question and Answer booklet to assist people when starting Prokarin. What I noticed from talking to about 1,500 patients, is that there were one of 3 variables present in those people who stated that they saw no improvement when using the Prokarin or some improvement in the first month but then lost these improvements in the following month. The three variables were: (1) the Prokarin was thick like toothpaste or spaghetti when it came out of the syringe despite holding the tip of the syringe down on the patch at a 45 degree angle (like a pencil on a piece of paper), (2) people were using an essential fatty acid supplement such as flaxseed oil, primrose oil, borage, fish oil or Omega 3 supplements, (3) the person was not heat sensitive. So I researched each of these variables and this is what I found regarding each:
(1) I had my pharmacist mix up my Prokarin a little thicker to a spaghetti consistency and a toothpaste consistency and sure enough, it had no effect. So then I had the pharmacist make it runny and it was a very transient effect—like a yo-yo. I would get a rush, heart pounding and headache and the beneficial effect would only last about 2 hours. So I researched why this was and found that histamine is metabolized very quickly in the body with a therapeutic effect (half-life) in the body of only about 50 minutes. Because Prokarin is a cream that is applied to a patch that sits on top of the skin and is slowly absorbed across the skin, the consistency of the cream plays a huge part in how fast the histamine is absorbed—the thicker the cream the slower the histamine is absorbed and the looser the cream the faster the Prokarin is absorbed. The mg/hour of any drug delivery is what is so important to get a therapeutic effect. Because histamine has less than an hour half-life in the body, the mg/hour delivery of the histamine has to be right on or you will never achieve that therapeutic value. Thus, the consistency of Prokarin had to be just right. Hence, we started offering compounding seminars on Prokarin. We offered the seminars on the East Coast, Southern, Middle, and West Coast (Georgia, Tennessee, New York, Illinois, Texas, Colorado, California, and Washington) to try and accommodate pharmacists attending. All attending pharmacies were asked to complete an evaluation of the seminar as we also had received accreditation for the seminars as qualifying for CEU credits which the pharmacists are required to have each year. This was done to further accommodate pharmacists attending. Unanimously, all of the pharmacies attending the compounding seminar stated that EDMS needed to make the seminar mandatory for a pharmacy that was making Prokarin. All pharmacists who attended said that they had been making the Prokarin too thick prior to the seminar and that after attending the seminar, patients were reporting better effects from the Prokarin. Unfortunately this was 20/20 hindsight in that we had already licensed 750 pharmacies and we had no way to force them to attend a seminar. So in an attempt to improve standards, we made it mandatory that a pharmacy attend a seminar in order for them to be listed on our website as a recommended pharmacy. Skip contacted me requesting that EDMS give him an exemption from attending a seminar, as he was very competent in making Prokarin. I explained to him that I could not make an exception for him and nor for the other 700+ pharmacies as I am sure each of them would claim the same. Once you make exceptions, you lose the quality standard you are trying to establish. Skip acknowledges the need for measures to establish quality standards such as the compounding seminars in compounding Prokarin in his posted message stating, “If others are incapable of compounding Prokarin, what does that say to you. It says to me that its not the histamine but the compounder.” In fact, Judi Richardson who developed the formula for me, attended a seminar and said that she found it very helpful as well in that we also discuss the biochemistry that I have learned through all of my research and how it can be applied to benefit numerous illnesses.

    (2) Despite the fact that the EFA’s have been strongly promoted as being very healthy due to their antioxidant effect and their anti-inflammatory effect, those people who were using the Prokarin as well as EFA’s reported a loss of the improvements seen in the very beginning using Prokarin. These patients reported a return of these improvements after stopping the EFA’s after 2-4 weeks. Again this prompted me to review research literature to see why the EFA’s appeared to interfere with the Prokarin. What I discovered was that the enzyme MAO-A that metabolizes histamine in the CNS into its active form (H2) is inhibited by lipid peroxidation. EFA supplements, which are a high concentration of polyunsaturated fats (meaning they have lots of double bonds), create toxins called lipid peroxides when they are metabolized in the body. These lipid peroxides will inhibit the production of H2. The burning (metabolism) of polyunsaturated fats creates lipid peroxide toxins whereas saturated fats (having only single bonds) do not. Our body is always trying to maintain a balance in such ratios as polyunsaturated fats to saturated fats, but it has no control over what we feed it. So if we feed it too many polyunsaturated fats then the only way the body can bring this back into balance with the saturated fats is to burn the excess polyunsaturated fats, which creates the lipid peroxide toxins and calories in the body. Yet if we feed the body too many saturated fats, then the body will burn the excess saturated fats and this just creates calories that can be stored as adipose tissue but it won’t create lipid peroxide toxins.

    (3) As many of you have probably heard me say, I don’t believe that MS is a disease but rather a condition in which numerous things can bring you to develop the condition. Much like heart disease is not truly a disease but rather a condition and numerous things can create the condition such as infection, genetics, lifestyle, stress, diet etc. Depending on what created the condition, one or many things, the treatment may need to be varied and the effects of one treatment will depend on the contributing factors to the development of the condition. Because H2 is impacted so much by stress, the H2 system can be impacted by any chronic stressor or condition resulting in many symptoms similar to MS, which makes MS difficult to diagnose and unfortunately we don’t have a definite diagnostic tool for MS. H2 is the heat stress regulator for the body and because of this it is probably the truest indicator of a true condition of MS. In fact, that is how they used to diagnose a person with MS, by putting them in a hot tub of water and if their symptoms worsened then they were given a diagnosis of MS. Thus the more sensitive a person is to stress or heat the more likely their H2 system was directly impacted. This has held true in that the more heat sensitive a person is the better they respond to Prokarin.

    From 1997 to 2002, the Prokarin was a two-patch a day system made originally at 1.1mg strength in the feasibility study and then later the majority of respondents reported seeing the best effect with 1.65mg strength. Thus, from July 1999 to December 2003 the average concentration strength was 1.65mg. But in April 2002 I noticed that I started to get some tingling back in my left foot. Increasing the dose helped but as the summer of 2002 came on I also noticed that a refill of Prokarin was only holding at the best a 30-day shelf life instead of the 60-day shelf life from the day it is compounded that I had seen from 1997-2002. I started receiving calls from patients reporting the same decrease of effect and shortened shelf life. After looking at the various components of the Prokarin formula it was determined that it had to be the histamine. I contacted the various chemical suppliers of histamine phosphate and none of them would tell me who the manufacturer was of the histamine phosphate. So in the fall of 2002, after searching for manufacturers of histamine phosphate USP in numerous countries, (Australia, Switzerland, England, Canada, Germany, France) I found only one manufacturer and it was just by the grace of God. I had contacted a chemical supplier and I asked them if they made their own histamine phosphate product and they reported no. I asked them the standard question I had asked all of the other suppliers if they would please tell me the name of the manufacturer. The lady said no that they won’t divulge that information and just as she said that, she sneezed. I said “God Bless You” and she promptly asked me to hold the line. I thought she had gone to get a tissue, but instead she returned to the phone with the name of the manufacturer. I have to believe God influenced her change of heart.

    Anyway, I contacted the manufacturer and told them my story of how their product had given me back my life but it seemed to be losing potency as of April 2002. They explained that they purchase histamine dihydrochloride from a Japanese company and then remove the hydrochloride and bind phosphate to it. They said that the Japanese company was no longer making the histamine dihydrochloride as of 1997 so they had purchased all of the product the company had at that time (1997) and it was from this product that the histamine phosphate was being made from. The last batch they had made was March 2002 and it was this batch that we had seen a decrease in shelf life and potency. They hypothesized that it may need to be dehydrated further so they did and this resulted in the Enhanced Prokarin that some of you might remember in the early part of 2003. The Enhanced Prokarin was extremely potent but seemed to accumulate after a few days of using it, requiring a drug holiday, so I notified all of the pharmacies to quit making it and we were forced to go back to what we had previous.

    By the fall of 2003, I needed to refill my Prokarin every 2 weeks to maintain beneficial effects. So I flew to meet with the histamine manufacturer to plead for their help in resolving this. Documentation states that the ringed molecule histamine has a 5-year shelf life from the date it is made from the amino acid histidine. Thus it was determined that the shelf life of the histamine dihydrochloride made in 1997 was the issue. The problem was the Japanese company no longer manufactured the histamine dihydrochloride. So the histamine phosphate manufacturer had to buy histamine dihydrochloride made by a Chinese company. I tried the Prokarin made from the Chinese product at 1.65mg, 0.8mg, and all the way down to 0.2mg strength. The only strength that I could tolerate was the 0.2mg strength and at that I found I could only tolerate one patch a day and I only used 0.06ml on the patch. Because this was such a small amount to dose and hard to see to dispense it on to the patch, I tried 0.1mg strength but found that it wouldn’t hold the 60-day shelf life at that weak of concentration. So we settled with the 0.2mg strength and one of the great benefits was that it only required one patch a day—a real plus. I, like many of you, noticed that it was a struggle with this one-patch a day Prokarin made from the Chinese product to find the right dose, but when you did it had a good effect. I believed the trials and tribulations were over, so I notified all of the pharmacies of my findings and hypothesized why we needed to use only one-patch a day and make it only 0.2mg strength was because it was so fresh as compared to the product we had been using from 1997.

    I suspected that as the Chinese product aged we would need to go back to the two-patch a day system and the concentration strength of 1.65mg in the future so I decided not to amend the patient application video and the Question and Answer booklet that showed a two-patch application. But instead by September 2004, it seemed that the Chinese product was getting stronger in that I now could only use 0.05ml or I would get aching in my legs and arms. Then again in December 2004 it seemed to change again in that I could only use 0.03ml or I would get aching in my legs and arms. So I flew to meet with a chemist, who referred me to an amino acid expert to try and explain these changes. I also contacted the Japanese company who originally made the histamine dihydrochloride to try and identify the differences I was seeing between the Japanese and Chinese product. I will attempt to explain it in layman terms what I found out.

    When they make the amino acid histidine they get a mixture of D and L isomers. This means that an amino group comes out of the top of the molecule in the D-isomer and out of the bottom of the molecule in the L-isomer. These amino groups pull the bond angles in different directions in the corresponding histamine molecule that is made from the histidine. The resulting bond angles in the histamine molecule determine what enzymes can dock up to the histamine molecule and how the histamine molecules can be stacked up. The D-isomer is not natural in mammals whereas the L-isomer is. Thus, it is harder for people to metabolize the histamine made from the D-isomer because our enzymes don’t fit these bond angles as well. Research shows that histamine made from the D-isomer results in hydrogen peroxide production when metabolized in mammals and histamine made from the L-isomer results in ammonia and urea when metabolized in us. We want the ammonia and urea end-products because ammonia increases the activity of the MAO-A enzyme so it can make more H2 and the urea protects our brain from dehydration and decreases muscle spasms and stiffness and other toxic effects from glutamate. (By the way, research shows that MS patients have dehydration of the brain and low uric acid levels).

    The Japanese company used the L-isomer to make the histamine whereas the Chinese company used the D and L isomer mixture. Because the D-isomer isn’t easily broken down by oxidation it is not broken down easily in our body or on our skin. This may explain why we only needed one patch with the Chinese product because it didn’t metabolize quickly in the body or breakdown easily under the patch against the skin, and why it didn’t create the skin irritation under the patch like the Japanese product did when air got under the patch. This may also explain why the Chinese product seems to require smaller doses as the product ages in that the histamine made from the D-isomer doesn’t breakdown with oxidation like the histamine made from the L-isomer which invariably happens over time. Thus, as the Chinese product ages it may result in more histamine from the D-isomer than histamine from the L-isomer making it so that smaller doses must be used.

    This also may explain why the Chinese product seems to cause aching in my arms and legs if the dose isn’t just right and gets worse if I increase it, because of the hydrogen peroxide that is the end-product of the metabolism of the histamine made from the D-isomer.

    So in light of this new information, I think it is necessary to go back to the histamine made from the L-isomer. I have found a US company that will make it and I have tried it and its effect is just like the Prokarin we used up until 2002. Other Prokarin users have reported the same. I am just in the process of getting the histamine phosphate switched with the chemical supplier but until that gets completed the new/new histamine is not available to all of the pharmacies as there is only a limited supply of it. I contacted some of the pharmacies such as Skip who have a lot of Prokarin patients to inform them of these coming changes and that there is a limited supply available right now. By the end of October it should be available to all the pharmacies.

    Now for the big question, can we keep the one-patch a day application with the new/new histamine. (Hey, maybe we should refer to it as Proklassic to avoid confusion.) As a long time Prokarin user, I can tell you I loved the convenience of one-patch a day. You could go out for the day and not have to calculate the logistics of should I carry a dose with me or will I be back to change the patch when I feel it wearing off. Sometimes I made the wrong decision and decided not to take a dose with me only to find me in a meltdown when my patch wore out and I had no Prokarin with me. As Prokarin users, you know that when the patch runs out, within an hour so do you. Anyway I tried to do various concentration ratios of the Proklassic and the Chinese product from a 90/10 to 98/2 mixture but everything above the 98/2 mixture gave me that aching in my legs and arms even mixed at the 0.2mg strength. The 98/2 didn’t give me the aching even at the 1.65 mg strength but my morning patch always ran out around 8 hours. So unfortunately we are going to have to use two-patches a day with the Proklassic.

    I know that some of you are doing fine with the one-patch a day Prokarin made from the Chinese product and you don’t want to change to the two-patch a day Proklassic. If the chemical supplier has both the histamine for the Proklassic as well as the histamine made from the Chinese product, it may result in confusion and because the two products require such different concentration strengths and application instructions this possible confusion must be avoided. The chemical supplier is requiring that I reimburse them for their current stock of the histamine made from the Chinese product—Ouch. Thus, I will see to it that a couple of pharmacies will have a supply of the Chinese product for those who want to continue on the one-patch a day, but I urge you to switch if you get aching as I think we need to listen to our body. I haven’t discussed this with Skip yet but it would be great if he would be one of the pharmacies that would be willing to supply both applications. My pharmacy has agreed to supply both as well and that way there will be one on the west coast and if Skip agrees one on the east coast.

    I apologize for the length of this explanation, but hopefully it will clear up any confusion you may have.

    I wish you all the best in your quest for health.

                                                                                                    Elaine DeLack, RN

Elaine DeLack's new book called "They Said It Didn't Make "Cents"-MS-The Prokarin Story",

if you are interested in purchasing, you can click here and visit this website www.msprokarinstory.com.

 

--------------------------------------------------------------------------------accine for use on a large scale is no longer compelling, experimental studies with

   

IS MULTIPLE SCLEROSIS A CASH

COW FOR THE MEDICAL FIELD?

"THE ORPHAN DRUG LAW"

 

             When I was officially diagnosed 18 years ago after having had the basic symptoms of MS for 36 years and was misdiagnosed five times, I was told three basic facts: 1) that there were between 250,000 and 300,000 people with MS, 2) between the ages of 20 to 40, and 3),  most of them were women.  I was also told that MS was NOT life threatening and was NOT considered a genetic disease. This same information has been passed on year after year. I think it is time we look at this information and evaluate its validity.

 

            Let’s do a little math here: There are surveys that report that there are 250 new cases of MS being diagnosed every day. Taking out for weekends and holidays, there are about 236 work days a year. (236 x 250 = 59,000 new cases of MS being diagnosed every year) Using the last 20 years as a bench mark, 20 years  x 59,000 new cases = 1,180,000 people with MS, NOT 250,000 to 300,000 as reported. Now if MS basically occurs between the ages of 20 to 40 and is NOT life threatening where are all these people with MS? One independent survey taken not too long ago reported 2,750,000 people with MS. MS is now being diagnosed in children and older people every day.  Regarding MS as not being genetic, there are numerous cases on file of several members of the same family as having MS. Who do we believe?

 

            Most of this information being reported today is to allow the medical field to hide behind the “Orphan Drug Law” written inn1983 and is still in effect.

            The following is the definition of the “Orphan Drug Law” for you to see how it is being used for the benefit of the drug manufactures and the many organizations raising money that support their research and development studies.

Table of Contents
FDA Consumer magazine
May-June 1999

US FOOD & DRUG ADMINISTRATION

by John Henkel

Orphan Drug Law Matures into Medical Mainstay

What Is an Orphan?

The Orphan Drug Act defines an orphan disease as a condition that affects fewer than 200,000 persons in the United States. More than 5,000 of these rare conditions exist in about 20 million Americans, according to the National Organization for Rare Disorders (NORD). Because no one would "adopt" the products to treat these diseases in the days before the law, they became known as "orphans."

An orphan disease may affect only a few thousand people--some, such as infant botulism, have patient populations of less than a hundred--so the potential for a company to profit from developing an orphan treatment is small.

 

This means that few firms, including large pharmaceutical companies, have been interested in investing the time and money in orphan products, says NORD president Abbey Meyers.

 

So for years, patients suffering from orphan diseases such as Gaucher's disease, rare cancers, hemophilia, multiple sclerosis, and Parkinson's disease simply were out of luck. With no financial incentives available, companies couldn't risk the investment. Other possible development outlets, such as universities or research hospitals, often lacked the capital or business savvy to develop treatments for small patient groups.

 

Orphans on a Roll

Pharmaceutical companies did, however, develop a few drugs of limited commercial potential in the 1960s and 1970s and even provided some at little or no charge. For example, the industry marketed Mithracin (plicamycin) to treat testicular cancer before the Orphan Drug Act was passed.

 

But by the early 1980s, only a handful of orphan treatments existed. A series of events, however, thrust the orphan issue into the public eye (see "How TV Launched the Orphan Drug Act."), and in 1982 Congress passed legislation giving generous incentives to companies willing to adopt orphans and bring treatments to market.

 

Since the act was signed, FDA has approved 182 orphan products--including drugs and biologics (see chart). Sponsors have submitted 1,252 applications for orphan designation, of which FDA has granted designation to 917. Orphan designation allows a company to proceed with development and take advantage of the law's financial incentives.

In 1998, FDA approved 18 new orphan products to treat conditions that include:

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While only drugs and biological products are eligible for orphan designations, regulations finalized in 1996 as part of the Humanitarian Use Devices (HUD) provisions of the Safe Medical Devices Act of 1990 created an exemption that makes it easier and less costly for manufacturers to bring orphan-related medical devices to market.

Under the exemption, FDA allows these devices to be sold if sponsors can show they are safe and have a probable benefit for patients. Sponsors do not need to prove effectiveness to get a HUD designation. Since July 1996, FDA has allowed 17 devices to be marketed as HUDs. None of these has yet received full FDA approval as a medical device, which would require clinical trials to prove effectiveness.

Powerful Incentives

While orphan interest from the large pharmaceutical firms remains limited in the wake of orphan law--only about 15 percent of applications come from the giant drug makers--some small companies have sprung up just to develop and market orphan products. In fact, orphan law can be credited with helping establish the American biotechnology industry, says John McCormick, M.D., deputy director of FDA's Office of Orphan Products Development.

 

"In the early '80s, patent laws for biotechnology were vague, so biotech companies had little protection for their products," says McCormick. He says a provision of the law that grants seven years of exclusive marketing rights is tantamount to a patent and allows a small company to proceed without fear that a competitor might market a similar product for the same condition. "Because many orphan diseases lend themselves to treatment with biotech products," says McCormick, "the exclusivity incentives have worked beautifully to foster innovative treatments by sheltering them from competition."

 

Though marketing exclusivity is likely the law's most powerful industry incentive, McCormick says, other provisions for orphan-designated products also are important motivators, including:

Meyers says NORD, which is a grassroots coalition of 140 voluntary rare-disease groups, is pleased with the approval rate of orphan products. "The thing that is so encouraging," she says, "is that the rest of the world has seen how the American [orphan] law has been so effective, and now they feel they have to have similar programs." Indeed, the European Union, Japan and Australia all have begun orphan programs of their own based on the U.S. model.

But are the goals of the original act on track 16 years later? "Definitely," says FDA's McCormick. "I think the framers of the act are all pleased as punch."

John Henkel is a staff writer for FDA Consumer.