MS Helping Hands - MSHH
Health & Safety Education
The 10 Steps of Having MS
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
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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Crohn's disease--Remicade (infliximab) is the first approved treatment for this chronic, incurable inflammatory bowel disease.
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Hansen's disease (leprosy)--FDA cleared thalidomide to treat a serious inflammatory symptom seen in Hansen's patients. Because of its well-known potential for causing birth defects, the drug was approved with tight restrictions on its use. "How encouraging it is that a medical tragedy [thalidomide birth defects in the 1960s] led to a medical breakthrough that will likely help people with many diseases," says Meyers. "Nobody would have done research on this aspect of thalidomide without the Orphan Drug Act." Thalidomide also has received orphan designation, though not approval yet, for treating primary brain tumors and Kaposi's sarcoma, an AIDS-related cancer.
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Sickle cell anemia--Under the orphan program, a decades-old cancer drug, hydroxyurea (Droxia) was approved to treat adults who suffer from this inherited blood disorder that causes chronic anemia and periodic episodes of pain.
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Cutaneous t-cell lymphoma--Ontak (denileukin diftitox) treats this slow-growing form of non-Hodgkin's lymphoma when other therapies have not worked.
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Pneumocystis carinii pneumonia (PCP)--Mepron (atovaquone) treats this infection that strikes high-risk, HIV-infected patients.
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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:
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Research grants--Managed by FDA, the Orphan Products Grant Program currently funds $11.5 million worth of clinical studies yearly. Sponsors engaged in clinical trials on the safety and effectiveness of orphan products can receive up to $200,000 a year for a maximum of three years. Since 1983, the program has awarded a total of $115 million and has funded 384 grant studies. In 1998, 28 researchers received grant money. Twenty-four grant-supported products have gone on to win FDA approval, including the most recent, Busulfex (busulfan), a treatment for a rare form of leukemia. A few devices have been approved as a result of FDA's Orphan Products Grant Program, including "neurostimulator implantable electrodes," which can restore some hand movements in quadriplegic patients.
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Protocol assistance--FDA helps orphan sponsors design research that conforms to regulatory requirements and shows them how to use the agency's review system. Small firms especially can save time and money using this service. "These companies just may not be as adept at jumping through the hoops as someone more experienced," says Meyers.
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Tax credits--Sponsors may claim 50 percent of clinical trial costs as a credit against taxes owed.
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.