MS Helping Hands - MSHH
Health & Safety Education
Articles Posted On This Page:
NEW
Elaine DeLack - The Prokarin Story
http://www.insidesuccessradio.com/Guests/Elaine-DeLack
May 25, '07
The Cheap, Safe and Effective Treatment for Multiple
Sclerosis That the
Drug Companies are Trying to Keep Secret
LDN
DEADLY IMMUNITY
Aspartame - What you don't know can hurt you!
Why isn't the FDA protecting your health?
DISASTER PROTECTION - SURVIVAL
"ARE YOU PREPARED?
The Triangle of Life - How to survive
WHAT'S IN YOUR WALLET?
CANCER MEDICAL HISTORY
PROKARIN CONFUSION
THEY SAID IT DIDN'T MAKE "CENTS"
- MS -
THE PROKARIN STORY
TAMIFLU
IS THE AVIAN FLU SCARE JUST HYPE ORCHESTRATED
TO INCREASE SALES OF TAMIFLU?
Finally the Facts are Told!
Finally a neuro journal is acknowledging this.
EAE labeled "misleading model of MS"
http://www.bostoncure.org:8080/article.pl?sid=05/12/12/136253
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
________________________________________________________________________________________________
LOW DOSE NALTREXONE (LDN)
FOR MULTIPLE SCLEROSIS
SammyJo Wilkinson has collected survey data from other MS patients using LDN, to help raise interest in clinical trials. Her success with LDN is being followed with interest by her neurologist at University of Texas Southwestern MS Center.
SammyJo has had MS for 10 years. In February '04 she was at the end of her rope after years of injectable drugs, IV steroids, plus a year of chemo to quell her immune system. She was barely walking with a cane and was just approved for a motorized wheelchair when she found LDN through her own research. She started at 2.0 mg the first month, then 4.5 mg. The first night she knew something was happening because she slept without leg spasms for the first time in years. Six weeks later she put down the cane, and by three months she could stay outside on hot summer days. She is now lifting weights to 100 lbs. She says she is in the best shape of her life and is looking forward to travel & adventure with her wonderful husband, Doug, of 20 years.
This inexpensive medication (around $15/mo) has been amazing for her and thousands of other people with MS. If you are a patient seeking an LDN prescription, take a copy of her survey results to your doctor. If you are a researcher, please help by starting clinical trials so others can learn why and how this medication works.
Once she started to feel better on LDN, she was able to make progress on the big job of rebuilding atrophied muscles, and learning to walk again. Remember, even if you start to feel better from LDN, you still need exercise, healthy foods and anti-oxidants. Refer to her MS Recovery website for further information.
February 2005 Update: It's been one year on LDN. Steady recovery with no set- backs continues. She still does physical therapy twice a week and can now walk a rapid 1/3 mile. October '04 she had an MRI, and when compared to the last one from May '03, there was no new activity.
SammyJo will be on the USERS PANEL at the First Annual LDN Conference June 11, 2005 in NYC.
SammyJo is a recent member of the Sno-King MS Support Group, and is already an active volunteer for MS Helping Hands – MSHH.
FOLLOW-UP ARTICLE AFTER THE FIRST ANNUAL LDN CONFERENCE
I previously reported on the success I’ve had recovering form Multiple Sclerosis using an FDA approved drug called Low Dose Naltrexone, such as escaping the wheelchair I was being measured for, and now able to walk 1 mile.
On June 11th 2005 I attended the First Annual Low Dose Naltrexone Conference at the New York Academy of Sciences in NYC. The conference room was filled with over 80 enthusiastic participants, including five panels of researchers, doctors, pharmacists, and LDN advocates. I was on the panel of LDN advocates, and presented my survey results of over 400 people using LDN for Multiple Sclerosis. These results found a very low relapse rate of 0.2, or 1 in 5 years; 70% reported symptom improvement; 45% said they felt progression had stopped. Detailed slides with these survey results are at http://www.LDNers.org
My survey results were corroborated by a similar survey by Dr. Skip Lenz of Skip’s Pharmacy, in which virtually all of the clients of his compounding pharmacy who have received prescriptions of LDN were surveyed. Of 238 patients, over 90% reported definite improvement or no worsening while using LDN. As Dr. Lenz put it: "These numbers are...beyond just maybe."
The other big news for those using LDN for MS is that Dr. Myra Gironi, MD, PhD, a neurological researcher from the University of Milan, Italy, spoke about her published findings of low endorphins in people with MS. She revealed that she is planning a clinical trial of LDN in the treatment of MS. When I spoke with her, she said my compilation of anecdotal information into statistically useful data had directed her attention to the effect LDN may have on low endorphins, and hence MS, since as an opiate blocker it tends to make these levels rise. I hope she will have success in unraveling this medical mystery. Meanwhile, I’m just glad it works for me, and so many others.
LDN is turning out to be effective for much more than MS, and is receiving research attention for conditions as varied as autism and Crohn’s Disease. Dr. Jill Smith, Professor of Gastroenterology at Penn State's Hershey Medical Center, recently completed an open-label, pilot feasibility study using low-dose naltrexone in Crohn's disease, beginning in November 2003. With her permission, it was reported at the conference that she was very pleased with the results of the study, and has submitted an application to the NIH to conduct a larger placebo-controlled trial. This would be the first scientific clinical trial using LDN to be accomplished at a US medical center.
This news from Penn State, and all the overwhelming information from MS patients, has inspired myself and a small group of organizers to launch a funding effort for a similar pilot study to be conducted at a major academic center in the US, investigating LDN for MS, which could lead to an NIH study should significance be established. Even though a trial is planned in Italy, it is always important for research to be conducted in multiple centers, so the results can be compared as further corroboration. Details on this can be found on http://LDNinfo.org
Articles submitted by SammyJo Wilkinson
Click on the following site to see a list of doctors who prescribe LDN
Shortcut to: http://ldn.proboards3.com/index.cgi?board=doctors&action=display&thread=1079158856
Join the Resistance
We've long known that resistance training (weight lifting) increases muscle strength and bone density and improves balance and coordination in people with unimpaired movement and no disabilities. Now, a study from the University of Florida tells us that resistance training also can help those whose muscles have been weakened by multiple sclerosis walk better and reduce fatigue.
About the Study
In the study, eight patients with multiple sclerosis (MS) ages 25 to 55 participated in a program that focused on exercising the legs, the lower back and the abdomen. Sessions lasted for 30 minutes, two times a week, and there was at least a 48-hour rest between exercise sessions. Conventional weight machines, typical of those found in any gym, were used. Subjects were supervised by trained exercise physiologists during all sessions.
There were no negative outcomes to weight training and no MS flair-ups were reported during the study. At the end of the eight weeks, patients had significantly stronger leg muscles, as evaluated by a machine called the isokinetic dynamometer. All patients were able to walk better, walk longer and reported less fatigue. More than half of the participants continued weight training after the study, Lesley White, PhD, lead researcher, reported.
The good news is that it appears from this study that MS patients are capable of making positive improvements in muscle strength through exercise, just as non-impaired persons are. To substantiate these findings, a four-month strength-training study is under way.
I asked Dr. White how our readers with MS could get themselves on a weight-training protocol. She suggested that patients first consult with both their neurologist and primary health care physician to talk about weight training and get physician clearance to participate in a weight-training program. Dr. White says that not every MS patient is able to participate in weight training because he/she may have additional medical conditions that prevent it or worsen with weight-bearing exercise -- but, it is certainly worth a conversation about the pros and cons with your doctor. Patients can refer their physicians to the original research, "Resistance training improves strength and functional capacity in persons with multiple sclerosis," published in volume 10 of the journal Multiple Sclerosis (2004).
If the MS patient is a good candidate, the neurologist can refer him to a physical therapist or exercise physiologist who is specifically trained to work with MS subjects and who can custom design a program and supervise sessions.
Be well,
Carole Jackson Bottom Line's
Daily Health
News
DEADLY IMMUNITY
The author provides a quote that states this
particular situation is bigger than the
asbestos or the tobacco cover-up. He could be
correct—unknown until 1943; now 500,000 children diagnosed in the
United States
with 40,000 more added each year.
Quote from below:
"The damage caused by vaccine exposure is
massive. It's bigger than asbestos, bigger
than tobacco
bigger than anything you've ever seen." It's
hard to calculate the damage to our
country-and to the international efforts to
eradicate epidemic diseases-if Third World
nations come to believe that America's most
heralded foreign-aid initiative is poisoning
their children.
When a study revealed that
mercury in childhood vaccines may have caused
autism in thousands of kids, the government
rushed to conceal the data - and to prevent
parents from suing drug companies for their
role in the epidemic.
By Robert F. Kennedy Jr.
June 16, 2005
In June 2000, a group of top government
scientists and health officials gathered for a
meeting at the isolated Simpsonwood conference
center in Norcross, Ga. Convened by the
Centers for Disease Control and Prevention,
the meeting was held at this Methodist retreat
center, nestled in wooded farmland next to the
Chattahoochee River, to ensure complete
secrecy. The agency had issued no public
announcement of the session-only private
invitations to 52 attendees.
There were high-level officials from the CDC
and the Food and Drug Administration, the top
vaccine specialist from the World Health
Organization in Geneva, and representatives of
every major vaccine manufacturer, including
GlaxoSmithKline, Merck, Wyeth and Aventis
Pasteur. All of the scientific data under
discussion, CDC officials repeatedly reminded
the participants, was strictly "embargoed."
There would be no making photocopies of
documents, no taking papers with them when
they left.
The federal officials and industry
representatives had assembled to discuss a
disturbing new study that raised alarming
questions about the safety of a host of common
childhood vaccines administered to infants and
young children. According to a CDC
epidemiologist named Tom Verstraeten, who had
analyzed the agency's massive database
containing the medical records of 100,000
children, a mercury-based preservative in the
vaccines-thimerosal-appeared to be responsible
for a dramatic increase in autism and a host
of other neurological disorders among
children. "I was actually stunned by what I
saw," Verstraeten told those assembled at
Simpsonwood, citing the staggering number of
earlier studies that indicate a link between
thimerosal and speech delays,
attention-deficit disorder, hyperactivity and
autism.
Since 1991, when the CDC and the FDA had
recommended that three additional vaccines
laced with the preservative be given to
extremely young infants-in one case, within
hours of birth-the estimated number of cases
of autism had increased fifteenfold, from one
in every 2,500 children to one in 166
children.
Even for scientists and doctors accustomed to
confronting issues of life and death, the
findings were frightening. "You can play with
this all you want," Dr. Bill Weil, a
consultant for the American Academy of
Pediatrics, told the group.
The results "are statistically significant."
Dr. Richard Johnston, an immunologist and
pediatrician from the University of Colorado
whose grandson had been born early on the
morning of the meeting's first day, was even
more alarmed. "My gut feeling?" he said.
"Forgive this personal comment-I do not want
my grandson to get a thimerosal-containing
vaccine until we know better what is going
on." But instead of taking immediate steps to
alert the public and rid the vaccine supply of
thimerosal, the officials and executives at
Simpsonwood spent most of the next two days
discussing how to cover up the damaging data.
According to transcripts obtained under the
Freedom of Information Act, many at the
meeting were concerned about how the damaging
revelations about thimerosal would affect the
vaccine industry's bottom line.
"We are in a bad position from the standpoint
of defending any lawsuits," said Dr. Robert
Brent, a pediatrician at the Alfred I. duPont
Hospital for Children in Delaware. "This will
be a resource to our very busy plaintiff
attorneys in this country." Dr. Bob Chen, head
of vaccine safety for the CDC, expressed
relief that "given the sensitivity of the
information, we have been able to keep it out
of the hands of, let's say, less responsible
hands." Dr. John Clements, vaccines advisor at
the World Health Organization, declared flatly
that the study "should not have been done at
all" and warned that the results "will be
taken by others and will be used in ways
beyond the control of this group. The research
results have to be handled."
In fact, the government has proved to be far
more adept at handling the damage than at
protecting children's health. The CDC paid the
Institute of Medicine to conduct a new study
to whitewash the risks of thimerosal, ordering
researchers to "rule out" the chemical's link
to autism. It withheld Verstraeten's findings,
even though they had been slated for immediate
publication, and told other scientists that
his original data had been "lost" and could
not be replicated. And to thwart the Freedom
of Information Act, it handed its giant
database of vaccine records over to a private
company, declaring it off-limits to
researchers. By the time Verstraeten finally
published his study in 2003, he had gone to
work for GlaxoSmithKline and reworked his data
to bury the link between thimerosal and
autism.
Vaccine manufacturers had already begun to
phase thimerosal out of injections given to
American infants-but they continued to sell
off their mercury-based supplies of vaccines
until last year. The CDC and FDA gave them a
hand, buying up the tainted vaccines for
export to developing countries and allowing
drug companies to continue using the
preservative in some American
vaccines-including several pediatric flu shots
as well as tetanus boosters routinely given to
11-year-olds.
The drug companies are also getting help from
powerful lawmakers in Washington. Senate
Majority Leader Bill Frist, who has received
$873,000 in contributions from the
pharmaceutical industry, has been working to
immunize vaccine makers from liability in
4,200 lawsuits that have been filed by the
parents of injured children. On five separate
occasions, Frist has tried to seal all of the
government's vaccine-related documents
including the Simpsonwood transcripts-and
shield Eli Lilly, the developer of thimerosal,
from subpoenas. In 2002, the day after Frist
quietly slipped a rider known as the "Eli
Lilly Protection Act" into a homeland security
bill, the company contributed $10,000 to his
campaign and bought 5,000 copies of his book
on bioterrorism. Congress repealed the measure
in 2003 -- but earlier this year, Frist
slipped another provision into an
anti-terrorism bill that would deny
compensation to children suffering from
vaccine-related brain disorders. "The lawsuits
are of such magnitude that they could put
vaccine producers out of business and limit
our capacity to deal with a biological attack
by terrorists," says Andy Olsen, a legislative
assistant to Frist.
Even many conservatives are shocked by the
government's effort to cover up the dangers of
thimerosal. Rep. Dan Burton, a Republican from
Indiana, oversaw a three-year investigation of
thimerosal after his grandson was diagnosed
with autism. "Thimerosal used as a
preservative in vaccines is directly related
to the autism epidemic," his House Government
Reform Committee concluded in its final
report. "This epidemic in all probability may
have been prevented or curtailed had the FDA
not been asleep at the switch regarding a lack
of safety data regarding injected thimerosal,
a known neurotoxin." The FDA and other
public-health agencies failed to act, the
committee added, out of "institutional
malfeasance for self protection" and
"misplaced protectionism of the pharmaceutical
industry."
The story of how government health agencies
colluded with Big Pharma to hide the risks of
thimerosal from the public is a chilling case
study of institutional arrogance, power and
greed. I was drawn into the controversy only
reluctantly. As an attorney and
environmentalist who has spent years working
on issues of mercury toxicity, I frequently
met mothers of autistic children who were
absolutely convinced that their kids had been
injured by vaccines. Privately, I was
skeptical.
I doubted that autism could be blamed on a
single source, and I certainly understood the
government's need to reassure parents that
vaccinations are safe; the eradication of
deadly childhood diseases depends on it. I
tended to agree with skeptics like Rep. Henry
Waxman, a Democrat from California, who
criticized his colleagues on the House
Government Reform Committee for leaping to
conclusions about autism and vaccinations.
"Why should we scare people about
immunization," Waxman pointed out at one
hearing, "until we know the facts?"
It was only after reading the Simpsonwood
transcripts, studying the leading scientific
research and talking with many of the nation's
preeminent authorities on mercury that I
became convinced that the link between
Thimerosal and the epidemic of childhood
neurological disorders is real. Five of my own
children are members of the Thimerosal
Generation-those born between 1989 and 2003 --
who received heavy doses of mercury from
vaccines.
"The elementary grades are overwhelmed with
children who have symptoms of neurological or
immune-system damage," Patti White, a school
nurse, told the House Government Reform
Committee in 1999. "Vaccines are supposed to
be making us healthier; however, in 25 years
of nursing I have never seen so many damaged,
sick kids. Something very, very wrong is
happening to our children." More than 500,000
kids currently suffer from autism, and
pediatricians diagnose more than 40,000 new
cases every year. The disease was unknown
until 1943, when it was identified and
diagnosed among 11 children born in the months
after thimerosal was first added to baby
vaccines in 1931.
Some skeptics dispute that the rise in autism
is caused by thimerosal-tainted vaccinations.
They argue that the increase is a result of
better diagnosis-a theory that seems
questionable at best, given that most of the
new cases of autism are clustered within a
single generation of children. "If the
epidemic is truly an artifact of poor
diagnosis," scoffs Dr. Boyd Haley, one of the
world's authorities on mercury toxicity, "then
where are all the 20-year-old autistics?"
Other researchers point out that Americans are
exposed to a greater cumulative "load" of
mercury than ever before, from contaminated
fish to dental fillings, and suggest that
thimerosal in vaccines may be only part of a
much larger problem. It's a concern that
certainly deserves far more attention than it
has received-but it overlooks the fact that
the mercury concentrations in
vaccines dwarf other sources of exposure to
our children.
What is most striking is the lengths to which
many of the leading detectives have gone to
ignore-and cover up-the evidence against
thimerosal. From the very beginning, the
scientific case against the mercury additive
has been overwhelming. The preservative, which
is used to stem fungi and bacterial growth in
vaccines, contains ethylmercury, a potent
neurotoxin. Truckloads of studies have shown
that mercury tends to accumulate in the brains
of primates and other animals after they are
injected with vaccines-and that the developing
brains of infants are particularly
susceptible. In 1977, a Russian study found
that adults exposed to much lower
concentrations of ethylmercury than those
given to American children still suffered
brain damage years later. Russia banned
thimerosal from children's vaccines 20 years
ago, and Denmark, Austria, Japan, Great
Britain and all the Scandinavian countries
have since followed suit.
You couldn't even construct a study that shows
thimerosal is safe," says Haley, who heads the
chemistry department at the University of
Kentucky. "It's just too darn toxic. If you
inject thimerosal into an animal, its brain
will sicken. If you apply it to living tissue,
the cells die. If you put it in a Petri dish,
the culture dies. Knowing these things, it
would be shocking if one could inject it into
an infant without causing damage."
Internal documents reveal that Eli Lilly,
which first developed thimerosal, knew from
the start that its product could cause
damage-and even death-in both animals and
humans. In 1930, the company tested thimerosal
by administering it to 22 patients with
terminal meningitis, all of who died within
weeks of being injected-a fact Lilly didn't
bother to report in its study declaring
thimerosal safe. In 1935, researchers at
another vaccine manufacturer, Pittman-Moore,
warned Lilly that its claims about
thimerosal's safety "did not check with ours."
Half the dogs Pittman injected with thimerosal-based
vaccines became sick, leading researchers
there to declare the preservative
"unsatisfactory as a serum intended for use on
dogs." In the decades that followed, the
evidence against thimerosal continued to
mount. During the Second World War, when the
Department of Defense used the preservative in
vaccines on soldiers, it required Lilly to
label it "poison." In 1967, a study in Applied
Microbiology found that thimerosal killed mice
when added to injected vaccines. Four years
later, Lilly's own studies discerned that
thimerosal was "toxic to tissue cells" in
concentrations as low as one part per million
-- 100 times weaker than the concentration in
a typical vaccine. Even so, the company
continued to promote thimerosal as "nontoxic"
and also incorporated it into topical
disinfectants. In 1977, 10 babies at a Toronto
hospital died when an antiseptic preserved
with thimerosal was dabbed onto their
umbilical cords.
In 1982, the FDA proposed a ban on
over-the-counter products that contained
thimerosal, and in 1991 the agency considered
banning it from animal vaccines. But
tragically, that same year, the CDC
recommended that infants be injected with a
series of mercury-laced vaccines. Newborns
would be vaccinated for hepatitis B within 24
hours of birth, and 2-month-old infants would
be immunized for homophiles influenzae B and
diphtheria-tetanus-pertussis. The drug
industry knew the additional vaccines posed a
danger. The same year that the CDC approved
the new vaccines, Dr. Maurice Hilleman, one of
the fathers of Merck's vaccine programs,
warned the company that 6-month-olds who were
administered the shots would suffer dangerous
exposure to mercury. He recommended that
thimerosal be discontinued, "especially when
used on infants and children," noting that the
industry knew of nontoxic alternatives. "The
best way to go," he added, "is to switch to
dispensing the actual vaccines without adding
preservatives."
For Merck and other drug companies, however,
the obstacle was money. Thimerosal enables the
pharmaceutical industry to package vaccines in
vials that contain multiple doses, which
require additional protection because they are
more easily contaminated by multiple needle
entries.
The larger vials cost half as much to produce
as smaller, single-dose vials, making it
cheaper for international agencies to
distribute them to impoverished regions at
risk of epidemics. Faced with this "cost
consideration," Merck ignored Hilleman's
warnings, and government officials continued
to push more and more thimerosal-based
vaccines for children. Before 1989, American
preschoolers received 11 vaccinations-for
polio, diphtheria-tetanus-pertussis and
measles-mumps-rubella. A decade later, thanks
to federal recommendations, children were
receiving a total of 22 immunizations by the
time they reached first grade. As the number
of vaccines increased, the rate of autism
among children exploded. During the 1990s, 40
million children were injected with thimerosal-based
vaccines, receiving unprecedented levels of
mercury during a period critical for brain
development. Despite the well-documented
dangers of thimerosal, it appears that no one
bothered to add up the cumulative dose of
mercury that children would receive from the
mandated vaccines. "What took the FDA so long
to do the calculations?" Peter Patriarca,
director of viral products for the agency,
asked in an e-mail to the CDC in 1999. "Why
didn't CDC and the advisory bodies do these
calculations when they rapidly expanded the
childhood immunizationschedule?"
But by that time, the damage
was done. Infants who received all their
vaccines, plus boosters, by the age of six
months were being injected with a total of 187
micrograms of ethylmercury-a level 40 percent
greater than the EPA's limit for daily
exposure to methylmercury, a related
neurotoxin. Although the vaccine industry
insists that ethylmercury poses little danger
because it breaks down rapidly and is removed
by the body, several studies-including one
published in April by the National Institutes
of Health-suggest that ethylmercury is
actually more toxic to developing brains and
stays in the brain longer than methylmercury.
Under the expanded schedule of vaccinations,
multiple shots were often administered on a
single day: At two months, when the infant
brain is still at a critical stage of
development, children routinely received three
innoculations that delivered 99 times the
approved limit of mercury. Officials
responsible for childhood immunizations insist
that the additional vaccines were necessary to
protect infants from disease and that
thimerosal is still essential in developing
nations, which, they often claim, cannot
afford the single-dose vials that don't
require a preservative. Dr. Paul Offit, one of
CDC's top vaccine advisors, told me, "I think
if we really have an influenza pandemic-and
certainly we will in the next 20 years,
because we always do-there's no way on God's
earth that we immunize 280 million people with
single-dose vials. There has to be multidose
vials."
But while public-health officials may have
been well intentioned, many of those on the
CDC advisory committee who backed the
additional vaccines ha close ties to the
industry. Dr. Sam Katz, the committee's chair,
was a paid consultant for most of the major
vaccine makers and shares a patent on a
measles vaccine with Merck, which also
manufactures the hepatitis B vaccine. Dr. Neal
Halsey, another committee member, worked as a
researcher for the vaccine companies and
received honoraria from Abbott Labs for his
research on the hepatitis B vaccine.
Indeed, in the tight circle of scientists who
work on vaccines, such conflicts of interest
are common. Rep. Burton says that the CDC
"routinely allows scientists with blatant
conflicts of interest to serve on intellectual
advisory committees that make recommendations
on new vaccines," even though they have
"interests in the products and companies for
which they are supposed to be providing
unbiased oversight." The House Government
Reform Committee discovered that four of the
eight CDC advisors who approved guidelines for
a rotavirus vaccine "had financial ties to the
pharmaceutical companies that were developing
different versions of the vaccine."
Offit, who shares a patent on one of the
vaccines, acknowledged to me that he "would
make money" if his vote eventually leads to a
marketable product. But he dismissed my
suggestion that a scientist's direct financial
stake in CDC approval might bias his judgment.
"It provides no conflict for me," he insists.
"I have simply been informed by the process,
not corrupted by it. When I sat around that
table, my sole intent was trying to make
recommendations that best benefited the
children in this country. It's offensive to
say that physicians and public-health people
are in the pocket of industry and thus are
making decisions that they know are unsafe for
children. It's just not the way it works."
Other vaccine scientists and regulators gave
me similar assurances. Like Offit, they view
themselves as enlightened guardians of
children's health, proud of their
"partnerships" with pharmaceutical companies,
immune to the seductions of personal profit,
besieged by irrational activists whose
anti-vaccine campaigns are endangering
children's health. They are often resentful of
questioning. "Science," says Offit, "is best
left to scientists."
Still, some government officials were alarmed
by the apparent conflicts of interest. In his
e-mail to CDC administrators in 1999, Paul
Patriarca of the FDA blasted federal
regulators for failing to adequately
scrutinize the danger posed by the added baby
vaccines. "I'm not sure there will be an easy
way out of the potential perception that the
FDA, CDC and immunization-policy bodies may
have been asleep at the switch re: thimerosal
until now," Patriarca wrote. The close ties
between regulatory officials and the
pharmaceutical industry, he added, "will also
raisequestions about various advisory bodies
regarding aggressive recommendations for use"
of thimerosal in child vaccines.
If federal regulators and government
scientists failed to grasp the potential risks
of thimerosal over the years, no one could
claim ignorance after the secret meeting at
Simpsonwood.
But rather than conduct more studies to test
the link to autism and other forms of brain
damage, the CDC placed politics over science.
The agency turned its database on childhood
vaccines-which had been developed largely at
taxpayer expense-over to a private agency,
America's Health Insurance Plans, ensuring
that it could not be used for additional
research. It also instructed the Institute of
Medicine, an advisory organization that is
part of the National Academy of Sciences, to
produce a study debunking the link between
thimerosal and brain disorders. The CDC "wants
us to declare, well, that these things are
pretty safe," Dr. Marie McCormick, who chaired
the IOM's Immunization Safety Review
Committee, told her fellow researchers when
they first met in January 2001. "We are not
ever going to come down that [autism] is a
true side effect" of thimerosal exposure.
According to transcripts of the meeting the
committee's chief staffer, Kathleen Stratton,
predicted that the IO would conclude that the
evidence was "inadequate to accept or reject a
causal relation" between thimerosal and
autism.
That, she added, was the result "Walt wants"-a
reference to Dr. Walter Orenstein, director of
the National Immunization Program for the CDC.
For those who had devoted their lives to
promoting vaccination, the revelations about
thimerosal threatened to undermine everything
they had
worked for. "We've got a dragon by the tail
here," said Dr. Michael Kaback, another
committee member. "The more negative that
[our] presentation is, the less likely people
are to use vaccination, immunization-and we
know what the results of that will be. We are
kind of caught in a trap. How we work our way
out of the trap, I think is the charge." Even
in public, federal officials made it clear
that their primary goal in studying thimerosal
was to dispel doubts about vaccines. "Four
current studies are taking place to rule out
the proposed link between autism and
thimerosal," Dr. Gordon Douglas, then-director
of strategic planning for vaccine research at
the National Institutes of Health, assured a
Princeton University gathering in May 2001.
"In order to undo the harmful effects of
research claiming to link the [measles]
vaccine to an elevated risk of autism, we need
to conduct and publicize additional studies to
assure parents of safety."
Douglas formerly served as president of
vaccinations for Merck, where he ignored
warnings about thimerosal's risks In May of
last year; the Institute of Medicine issued
its final report. Its conclusion: There is no
proven link between autism and thimerosal in
vaccines. Rather than reviewing the large body
of literature describing the toxicity of
thimerosal, the report relied on four
disastrously flawed epidemiological studies
examining European countries, where children
received much smaller doses of thimerosal than
American kids. It also cited a new version of
the Verstraeten study, published in the
journal Pediatrics that had been reworked to
reduce the link between thimerosal and autism.
The new study included children too young to
have been diagnosed with autism and overlooked
others who showed signs of the disease. The
IOM declared the case closed and-in a
startling position for a scientific
body-recommended that no further research be
conducted. The report may have satisfied the
CDC, but it convinced no one. Rep. David
Weldon, a Republican physician from Florida
who serves on the House Government Reform
Committee, attacked the Institute of Medicine,
saying it relied on a handful of studies that
were "fatally flawed" by "poor design” and
failed to represent "all the available
scientific and medical research." CDC
officials are not interested in an honest
search for the
truth, Weldon told me, because "an association
between vaccines and autism would force them
to admit that their policies irreparably
damaged thousands of children. Who would want
to make that conclusion about themselves?"
Under pressure from Congress, parents and a
few of its own panel members, the Institute of
Medicine reluctantly convened a second panel
to review the findings of the first. In
February, the new panel, composed of different
scientists, criticized the earlier panel for
its lack of transparency and urged the CDC to
make its vaccine database available to the
public.
So far, though, only two scientists have
managed to gain access. Dr. Mark Geier,
president of the Genetics Center of America,
and his son, David, spent a year battling to
obtain the medical records from the CDC. Since
August 2002, when members of Congress
pressured the agency to turn over the data,
the Geiers have completed six studies that
demonstrate a powerful correlation between
thimerosal and neurological damage in
children. One study, which compares the
cumulative dose of mercury received by
children born between 1981 and 1985 with those
born between 1990 and 1996, found a "very
significant relationship" between autism and
vaccines. Another study of educational
performance found that kids who received
higher doses of thimerosal in vaccines were
nearly three times as likely to be diagnosed
with autism and more than three times as
likely to suffer from speech disorders and
mental retardation. Another
soon-to-be-published study shows that autism
rates are in decline following the recent
elimination of thimerosal from most vaccines.
As the federal government worked to prevent
scientists from studying vaccines, others have
stepped in to study the link to autism. In
April, reporter Dan Olmsted of UPI undertook
one of the more interesting studies himself.
Searching for children who had not been
exposed to mercury in vaccines-the kind of
population that scientists typically use as a
"control" in experiments--Olmsted scoured the
Amish of Lancaster County, Penn., who refuse
to immunize their infants. Given the national
rate of autism, Olmsted calculated that there
should be 130 autistics among the Amish. He
found only four. One had been exposed to high
levels of mercury from a power plant. The
other three-including one child adopted from
outside the Amish community-had received their
vaccines.
At the state level, many officials have also
conducted in-depth reviews of thimerosal.
While the Institute of Medicine was busy
whitewashing the risks, the Iowa Legislature
was carefully combing through all of the
available scientific and biological data.
"After three years of review, I became
convinced there was sufficient credible
research to show a link between mercury and
the increased incidences in autism," says
state Sen. Ken Veenstra, a Republican who
oversaw the investigation. "The fact that
Iowa's 700 percent increase in autism began in
the 1990s, right after more and more vaccines
were added to the children's vaccine
schedules, is solid evidence alone." Last
year, Iowa became the first state to ban
mercury in vaccines, followed by California.
Similar bans are now under consideration in 32
other states. But instead of following suit,
the FDA continues to allow manufacturers to
include thimerosal in scores of
over-the-counter medications as well as
steroids and injected collagen. Even more
alarming, the government continues to ship
vaccines preserved with thimerosal to
developing countries-some of which are now
experiencing a sudden explosion in autism
rates. In China, where the disease was
virtually unknown prior to the introduction of
thimerosal by U.S. drug manufacturers in 1999,
news reports indicate that there are now more
than 1.8 million autistics. Although reliable
numbers are hard to come by, autistic
disorders also appear to be soaring in India,
Argentina, Nicaragua and other developing
countries that are now using thimerosal-laced
vaccines. The World Health Organization
continues to insist thimerosal is safe, but it
promises to keep the possibility that it is
linked to neurological disorders "under
review." I devoted time to study this issue
because I believe that this is a moral crisis
that must be addressed. If, as the evidence
suggests, our public-health authorities
knowingly allowed the pharmaceutical industry
to poison an entire generation of American
children, their actions arguably constitute
one of the biggest scandals in the annals of
American medicine. "The CDC is guilty of
incompetence and gross negligence," says Mark
Blaxill, vice president of Safe Minds, a
nonprofit organization concerned about the
role of mercury in medicines. "The damage
caused by vaccine exposure is massive. It's
bigger than asbestos, bigger than tobacco,
bigger than anything you've ever seen." It's
hard to calculate the damage to our
country-and to the international efforts to
eradicate epidemic diseases-if Third World
nations come to believe that America's most
heralded foreign-aid initiative is poisoning
their children. It's not difficult to predict
how this scenario will be interpreted by
America's enemies abroad. The scientists and
researchers-many of them sincere, even
idealistic-who are participating in efforts to
hide the science on thimerosal claim that they
are trying to advance the lofty goal of
protecting children in developing nations from
disease pandemics. They are badly misguided.
Their failure to come clean on thimerosal will
come back horribly to haunt our country and
the world's poorest populations.
About the writer
Robert F. Kennedy Jr. is senior attorney for
the Natural Resources Defense
Council, chief prosecuting attorney for
Riverkeeper and president of
Waterkeeper Alliance. He is the co-author of
"The Riverkeepers."
Helen
"Flexible people don't get bent out of shape."
http://www.thisholyinstant.com
Outgoing mail is certified Virus Free.
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.)
ARE YOU PREPARED?
The tragic after affects of the Hurricane that hit the Gulf States has caused many of us to ask the question: “AM I PREPARED FOR AN EMERGENCY, ANY EMERGENCY?” The answer for most of us is NO! As we all know, we live in earthquake country. Even a house fire can catch us off guard. Now is the time to act, NOT just think about it. What can you do to prepare for such an emergency? You can start with an emergency survival kit and an evacuation plan. In many cases you won’t have time to try and put together the basic items you will need to survive for even a short length of time once the disaster has occurred.
Go to Home Depot, Lowe’s, Fred Meyers, or such and get a large plastic storage container with a snap on lid. “Why not use a paper box?” you ask: Because a paper box will shred and fall apart if it gets wet.
Now put in the basic items you will need to help you survive for 3 to 4 days, or longer if need be. These items consist of: Bottled water, first aid kit, flashlight with extra batteries, scissors, a sharp pocket knife, small sewing kit, matches, flares, small tool kit, rope, heavy weight socks, underwear, sturdy walking shoes, sweater or jacket, stocking cap, gloves, packaged meals, blanket: if you have small children, diapers, baby powder, extra warm clothing, baby blanket: keep your medication handy at all times and have a plastic bag or container handy so you can grab it in a hurry.
Don’t let your car’s gas tank get below ½ full (and besides it is cheaper to fill half a tank instead of an empty tank), keep wallet handy and try to have at least $50 to $100 available in it.
When you go to bed at night, lay out your clothes, shoes and socks so you can dress in a hurry and don’t have to look for something to wear: Keep the emergency survival kit handy to put into your car when needed. Some people leave the “BASIC” emergency survival kit in the car or van and just add to it in a hurry.
The 6 must-do's,
If you do nothing else, do these six things to prepare for a disaster:
• Talk about preparedness with everyone in your home.
• Have an out-of-area contact.
• Secure appliances and address hazards in your home.
• Create a three-day disaster kit in a duffel bag or backpack.
• Keep your gas tank at least a quarter full.
• Keep a modest amount of cash handy.
Then after you get your own act together, put together a family plan with the rest of the entire family. Be sure to include the children as much as possible.
Have a plan as to who covers who with the children or grandchildren in school if the parents are unable to pick them up.
Cell phones are great, so be sure you have all the correct phone numbers, (home & Cell) of the other members of the family.
Don’t forget to program “911” and “ICE” into your cell phones.
The Triangle of Life - How to survive
Edited by Larry Linn for MAA Safety Committee brief on 4/13/04.
My name is Doug Copp. I am the Rescue Chief and Disaster Manager of the American Rescue Team International (ARTI), the world's most experienced rescue team. The information in this article will save lives in an earthquake.
I have crawled inside 875 collapsed buildings, worked with rescue teams from 60 countries, founded rescue teams in several countries, and I am a member of many rescue teams from many countries. I was the United Nations expert in Disaster Mitigation for two years. I have worked at every major disaster in the world since 1985, except for simultaneous disasters.
In 1996 we made a film which proved my survival methodology to be correct. The Turkish Federal Government, City of Istanbul, University of Istanbul Case Productions and ARTI cooperated to film this practical, scientific test. We collapsed a school and a home with 20 mannequins inside. Ten mannequins did "duck and cover," and ten mannequins I used in my "triangle of life" survival method. After the simulated earthquake collapse we crawled through the rubble and entered the building to film and document the results. The film, in which I practiced my survival techniques under directly observable, scientific conditions, relevant to building collapse, showed there would have been zero percent survival for those doing duck and cover. There would likely have been 100 percent survivability for people using my method of the "triangle of life" This film has been seen by millions of viewers on television in Turkey and the rest of Europe, and it was seen in the USA, Canada and Latin America on the TV program Real TV.
The first building I ever crawled inside of was a school in Mexico City during the 1985 earthquake. Every child was under their desk. Every child was crushed to the thickness of their bones. They could have survived by lying down next to their desks in the aisles. It was obscene, unnecessary and wondered why the children were not in the aisles. I didn't at the time know that the children were told to hide under something.
Simply stated, when buildings collapse, the weight of the ceilings falling upon the objects or furniture inside crushes these objects, leaving a space or void next to them. This space is what I call the "triangle of life". The larger the object, the stronger, and the less it will compact. The less the object compacts, the larger the void, the greater the probability that the person who is using this void for safety will not be injured. The next time you watch collapsed buildings on television, count the "triangles" you see formed. They are everywhere. It is the most common shape, you will see, in a collapsed building. They are everywhere.
TEN TIPS FOR EARTHQUAKE SAFETY
1) Most everyone who simply "ducks and covers" when buildings collapse are crushed to death. People who get under objects, like desks or cars, are crushed.
2) Cats, dogs and babies often naturally curl up in the fetal position. You should too in an earthquake. It is a natural safety/survival instinct. You can survive in a smaller void. Get next to an object, next to a sofa, next to a large bulky object that will compress slightly but leave a void next to it.
3) Wooden buildings are the safest type of construction to be in during an earthquake. Wood is flexible and moves with the force of the earthquake. If the wooden building does collapse, large survival voids are created. Also, the wooden building has less concentrated, crushing weight. Brick buildings will break into individual bricks. Bricks will cause many injuries but less squashed bodies than concrete slabs.
4) If you are in bed during the night and an earthquake occurs, simply roll off the bed. A safe void will exist around the bed. Hotels can achieve a much greater survival rate in earthquakes, simply by posting a sign on the back of the door of every room telling occupants to lie down on the floor, next to the bottom of the bed during an earthquake.
5) If an earthquake happens and you cannot easily escape by getting out the door or window, then lie down and curl up in the fetal position next to a sofa, or large chair.
6) Most everyone who gets under a doorway when buildings collapse is killed. How? If you stand under a doorway and the doorjamb falls forward or backward you will be crushed by the ceiling above. If the door jam falls sideways you will be cut in half by the doorway. In either case, you will be killed!
7) Never go to the stairs. The stairs have a different "moment of frequency" (they swing separately from the main part of the building). The stairs and remainder of the building continuously bump into each other until structural failure of the stairs takes place. The people who get on stairs before they fail are chopped up by the stair treads – horribly mutilated. Even if the building doesn't collapse, stay away from the stairs. The stairs are a likely part of the building to be damaged. Even if the stairs are not collapsed by the earthquake, they may collapse later when overloaded by fleeing people. They should always be checked for safety, even when the rest of the building is not damaged.
8) Get Near the Outer Walls Of Buildings Or Outside Of Them If Possible. It is much better to be near the outside of the building rather than the interior. The farther inside you are from the outside perimeter of the building the greater the probability that your escape route will be blocked.
9) People inside of their vehicles are crushed when the road above falls in an earthquake and crushes their vehicles; which is exactly what happened with the slabs between the decks of the Nimitz Freeway The victims of the San Francisco earthquake all stayed inside of their vehicles. They were all killed. They could have easily survived by getting out and sitting or lying next to their vehicles. Everyone killed would have survived if they had been able to get out of their cars and sit or lie next to them. All the crushed cars had voids 3 feet high next to them, except for the cars that had columns fall directly across them.
10) I discovered, while crawling inside of collapsed newspaper offices and other offices with a lot of paper, that paper does not compact. Large voids are found surrounding stacks of paper. =20 =20
Spread the word to everyone YOU care about and save someone's life!
WHAT’S IN YOUR WALLET?
NO, this isn’t a Capital One Commercial. If you were to lose your wallet, your whole life could be shattered if the contents fell into the wrong hands. What you should do is to: Place the contents of your wallet on a photocopy machine, copy both sides of your driver’s license, credit cards, medical cards, social security card, Medicare & Medicaid cards, and any other important documents you carry in your wallet. You will know what you had in your wallet and all of the account numbers and phone numbers to call and cancel. Keep the photocopy in a safe place. If you would like to come down to the MSHH office, you can use the photo-copier there at NO cost to make your photo copies to protect yourself. Call (425) 712-1804 and let us know when you would like to come in. You can make duplicate copies if you want to!
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INVITATION
TO PARTICIPATE IN MEDICAL HISTORY We alert you to the astounding findings of Certified Board Oncologist, James Wm. Forsythe, MD, HMD, of the Century Wellness Clinic in Reno, Nevada (775) 827-0707 - www.DrForsythe.com - who is conducting a study of Stage 4 Cancer with 170 patients using Poly-MVA. In this study, Dr. Forsythe has documented an unprecedented remission rate in these patients over 70% to date!!! This study presently is being expanded to up to 500 patients. We invite those who doubt these Stunning Results to contact us and The Foundation for Advancement in Cancer Research pledges to help you fund your own studies in order to corroborate Dr. Forsythes results in his current studies. Poly-MVA has also proved beneficial not only for Cancer but Stroke, Endometriosis and Psoriasis as well. Studies and Science will be electronically mailed upon request. This invitation is open to all private Institutions or government Agencies. We especially invite the American Cancer Society and the FDA to verify the efficacy of Poly-MVA with their own studies. Our mission is to do all in our power to help prevent so many tragic deaths Participate in history by helping us to allay all doubts on the efficacy of this product by effecting your own study at our cost. Respond to: The Foundation for Advancement in Cancer Research - 619-575-9474 / DrAlbertSanchez@msn.com For Financial help: The Sanchez Foundation Project of The National Heritage Foundation - (631) 439-1515 / Rick@SanchezFoundation.org 539 TELEGRAPH CANYON #281 CHULA VISTA, CA 91910, PH: (619) 575-2074 |
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.
IS THE AVIAN FLU SCARE JUST HYPE ORCHESTRATED
TO INCREASE SALES OF TAMIFLU?
As you know this is the time of year that they usually try to scare the public into getting flu vaccines, but after last year when they ran out of vaccine, they told people not to panic that they would be fine without receiving the vaccine and guess what--the people were fine.
Oops--so now how do they create the increased revenue that they have seen from previous years during the flu season? Answer--through hype of a possible pandemic that flu vaccines won't protect you from--let's use the Avian flu H5N1 that infects mainly poultry.
Well I bet you didn't know that this is not a new flu unknown to us. In 1997 there was an outbreak in Hong Kong of the H5N1 Avian flu. Now this is an area that is heavily populated and only 18 people contracted the disease of which 6 of them all under the age of 12 died. The transmission was very rare from person to person and the affected people had direct contact with the chickens in their pens.
Here is the link where you can read about the Hong Kong outbreak or you can read the copied text version below. Then after reading the facts of an actual outbreak of the Avian Flu H5N1 in Hong Kong in 1997, read what ABC News broadcasted: Avian Flu: Is the Government Ready for an Epidemic?
http://abcnews.go.com/Primetime/Investigation/story?id=1130392&page=1
http://www.info.gov.hk/dh/diseases/ph&eb/9902.htm
Members
Dr. Y H Chong
Dr. Cindy Lai
Dr. Miranda Lee
Dr. Gloria Tam
Dr Monica Wong
Mr. Simon Yeung
The publication is produced by
Department of Health,
21/F, Wu Chung House,
213 Queen's Road East,
Hong Kong.
All rights reserved
--------------------------------------------------------------------------------
THE AVIAN FLU (H5N1): ONE YEAR ON Dr S Y Lee1, Dr K H Mak2, Dr T A Saw3
INTRODUCTION
In 1997, the world's attention was focused on Hong Kong Special Administrative Region (HKSAR) as human cases of influenza A (H5N1) were diagnosed one after another. The potential of this Avian flu virus to become a pandemic strain in human immediately became a matter of global concern. Joint efforts of local and international health authorities, academics and administrators to contain the outbreak reached a climax during the chicken slaughtering operation in late December 1997. Subsequently, stringent control measures were observed at various levels to prevent recurrent H5N1 infection in chickens, and to prevent transmission of the virus to man should infection occur in chickens. One year after the incident, this paper summarizes past and present efforts to contain the outbreak and prevent further cases, and puts forward recommendations for future prevention strategies.
The Influenza A (H5N1) Outbreak
The first human case of H5N1 infection occurred in a 3-year old boy who presented with fever, sore throat and abdominal pain in May 1997. He subsequently died from respiratory failure and various complications including multi-organ failure and Reye's syndrome. A tracheal aspirate specimen yielded atypical influenza A virus. The isolates were confirmed in August 1997 by reference laboratories in the Netherlands and the Centre’s for Disease Control and Prevention (CDC) in the United States to be an Avian flu A virus: H5N1, which until then has been known to infect birds only.
In view of the potential risk of a new influenza strain in humans, prompt actions were taken by the Department of Health (DH) in collaboration with local experts, World Health Organization (WHO) and CDC upon identification of the first human case of H5N1 in August 1997. Investigations revealed that an outbreak of avian flu had occurred in chicken farms in the northwestern part of Hong Kong (Lau Fau Shan, Yuen Long) in March and April 1997. The virus that had killed more than 4,000 chickens was also found to be H5N1. Other actions consisting of field visits, interviews and laboratory investigations were conducted and joined by experts from local universities, Hospital Authority, CDC, and other government departments. Surveillance of H5N1 in human and poultry was stepped up and the laboratory capacity was enhanced.
The second case of H5N1 infection was confirmed on 26 November 1997 and more cases appeared in December 1997 (Figure 1). There were a total of 18 confirmed cases affecting 8 males and 10 females. Their ages ranged from 1 to 60 with half of them aged 12 and below. Six of them passed away due to viral pneumonia or other medical complications. The remaining twelve cases made a full recovery from the illness. The cases were scattered in different residential districts (Figure 2).
Meticulous investigations were conducted to elucidate the mode of transmission, the extent of infection and possible spread of this virus. Field visits, laboratory tests, and epidemiological studies were done in collaboration with local and overseas experts.
When the HKSAR Government obtained the evidence that the H5N1 virus was circulating among the poultry population, a decision was made on 28 December 1997 to slaughter all the poultry in farms and markets. The operation started on 29 December 1997 and no new infections appeared afterwards (Table 1). Text version
Text version Table 1 Chronology of Influenza A (H5N1) Outbreak in HKSAR 1997
Text version March/April 1997 Avian flu outbreak among chicken farms in northwestern part of Hong Kong. 9.5.1997.
Onset of illness for the first case of influenza A (H5N1.18.8.1997 Laboratory confirmation of H5N1 infection for the first case. 26.11.1997
Confirmation of the second case of human infection. December 1997 Isolation of H5N1 virus for chicken markets.
More human cases. 23.12.1997 Poultry export from Mainland suspended at midnight. 28.12.1997
Evidence of widespread H5N1 infection in a chicken farm and wholesale market. 29.12.1997 Slaughtering of chickens and poultry commenced.
No new human infections occurred since then.
Measures Taken to Contain the Influenza A (H5N1) Outbreak
To contain the outbreak and to minimize the risk of recurrence, a whole host of measures were implemented and coordinated by an inter-departmental coordinating committee:
I. PRE-SLAUGHTER MEASURES
(1) Influenza surveillance was further enhanced. The sentinel surveillance network was extended on 11 December 1997 to cover all public hospitals, all the 63 public out-patient clinics and 18 (now 28) private doctors. Virology tests for confirmation were provided to private laboratories which performed Directigen tests. In addition, hospital cases of respiratory infections, pneumonia and influenza-like illness were monitored.
(2) Guidelines on influenza prevention and proper hygiene were prepared for doctors, health care workers, and staff of schools, child care centre’s and elderly centre’s as well as poultry workers. The Hospital Authority prepared special guidelines for hospital infection control and developed quick tests for rapid diagnosis for Influenza A.
(3) Collaboration with CDC was expanded to include case investigations, epidemiological studies, development of diagnostic serological and confirmatory tests for the new virus and technology transfer. Close liaison was also maintained with WHO on related issues including vaccine development and pandemic planning.
`(4) The Mainland voluntarily suspended export of chickens to HKSAR from midnight of 23 December 1997 to allow new control measures be developed and implemented.
II. POST-SLAUGHTER MEASURES
(1) Enhanced influenza surveillance was maintained. During the year 1998, over 20 000 flu specimens were submitted by the sentinel surveillance network and hospitals for testing by the Government Virus Unit. No new H5N1 infections were discovered.
(2) Hospital admissions due to respiratory tract infections were also monitored. Apart from the usual seasonal upsurge in spring months, there was no significant change in the incidence of influenza-like illnesses, respiratory infections and pneumonia during the year 1998.
(3) Safe supply of chickens was ensured through the following measures:
New poultry import control measures include segregation of chickens in designated farms in the Mainland for five days, examination and testing for H5 infection in poultry before export, introduction of health certificate and use of rapid diagnostic tests on chickens for H5 infection upon arrival. By 1998, over 200,000 blood samples have been examined and no evidence of infection with avian influenza (H5) has been detected in any consignments.
A policy to segregate chickens from waterfowls has been recommended for implementation at all levels from import to retail. Poultry surveillance in farms was introduced along with new licensing conditions covering hygiene and management practices. All flocks are to be serologically tested during the growing period. All farms have remained free from infection with H5 influenza virus so far. Testing programs were instituted on other farms raising quails, ducks and pigeons etc. No evidence of infection has been detected in any of these farms.
(4) A high standard of cleanliness and hygiene is maintained in the markets and enforcement actions against contravention of licensing conditions have been stepped up.
Additional requirements and conditions have been imposed on licensees to achieve a high standard of hygiene including the use of plastic or metal poultry cages only, keeping the premises clean and keeping the processing of chickens hygienic and safe to staff.
(5) A contingency plan for influenza pandemic was drawn up with emphasis on influenza surveillance, provision of medical service, stocking of medicine for chemoprophylaxis and presumptive treatment of influenza A cases where necessary.
RESULTS OF INVESTIGATIONS AND STUDIES
Much energy and attention have been devoted by all concerned to ensure that the epidemiological investigations and studies are robust and properly carried out. Work is still ongoing at this stage. The main findings available are summarized as below:
(1) INVESTIGATION OF THE FIRST CASE
Five (1.1%) out of 476 persons investigated were found to have H5 antibody. Among the five seropositives, one had exposure to the patient only, three had exposure to poultry only, and the remaining one had exposure to both. The results suggest that the main mode of transmission is from bird to man.
(2) GENE SEQUENCING
Gene sequencing results show that all the viral genes of the H5N1 viruses are avian in nature and that these Avian viruses were able to infect humans without re-assortment with human virus. The viruses isolated from patients are nearly identical to those from chickens. Hence, the source of infection was most likely from poultry. The virus isolates fall into two closely related but distinguishable groups. This implies that multiple introduction from poultry to man have occurred.
(3) CASE-CONTROL STUDY
The results of a case-control study jointly carried out by DH and CDC on influenza A (H5N1) in HKSAR found that visiting poultry stalls in the one week before becoming ill was the strongest risk factor for infection by those viruses.
(4) COHORT STUDIES
Cohort studies were done on health care workers, classmates and colleagues of patients. The results suggest that health care workers who took care of more sick and dependent influenza A (H5N1) patients, especially before the diagnosis of H5N1 infection was made, had a higher chance of contracting the virus. However, such man-to-man transmission was inefficient as reflected by the low prevalence (3%) of antibody among the exposed health care workers.
(5) ANIMAL STUDIES
Meticulous animal and poultry studies were conducted to examine the extent of H5N1 infection in the animal population. Intensive sampling was done for poultry in the markets before the chicken slaughtering commenced. It was found that nearly 20% of the chickens in the markets were infected by the H5N1 virus while only about 2% of the ducks and geese in the markets carried this virus. This provides the evidence that the H5N1 virus was widespread among the chicken population. On the other hand, samples taken after the slaughtering exercise from chickens, ducks, waterfowls, rats, feral birds, stray and pet animals, etc, did not reveal any evidence of H5N1 infection. Only a few unidentified influenza viruses were detected from farm ducks and waterfowl. These findings illustrate that the market chickens were probably the major source of H5N1 virus for the community.
Hence, the slaughter of all chickens and market aquatic birds had effectively abolished the virus load and helped to bring the outbreak to an end.
Up to now, all investigation results have indicated that the main mode of transmission for H5N1 viruses is from bird to man. The man-to-man transmission did occur but was inefficient and rare.
RECOMMENDATIONS
The actions and measures taken to contain the influenza A (H5N1) outbreak and to prevent its further spread were effective. In order to protect the community against the threat of H5N1 and other viruses, the following control and preventive measures, already in place, should be maintained with vigor.
INFLUENZA SURVEILLANCE
The surveillance of influenza in the human population should be continued and further expanded, resources permitting. The influenza surveillance in animals and poultry should be maintained and further enhanced whenever possible. Global networking and collaboration, particularly exchange of epidemiological information, technology transfer and capacity building, should be enhanced and improved.
INFLUENZA PANDEMIC PLAN
A contingency plan has been drawn up and should be regularly updated.
VACCINE DEVELOPMENT
The development of H5 vaccine should be kept under close review. Although the existing evidence illustrates that the man-to-man transmission is inefficient, and hence the need for developing a vaccine for use on a large scale is no longer compelling, experimental studies with pilot lots of H5 vaccine should continue.
DISCONTINUE MIXED FARMING
Mixed farming involving chickens and pigs or water birds should be discouraged and phased out.
CONCLUSIONS AND LESSONS LEARNED
Influenza is a continuing threat to every health authority of the world. Southern China, including HKSAR, is known to be an epicenter of this disease entity because of its unique ecological environment in which man and animals, especially poultry, live in close proximity. The H5N1 outbreak, which occurred in Hong Kong from May to December 1997 and affected 18 residents with 6 deaths, illustrates how influenza viruses can spread easily, and even cross the species barrier from poultry to man. It also reaffirms the importance of a sound and robust public health system for early identification and prompt containment of new and re-emerging human pathogens before they can develop the potential to cause a worldwide pandemic. The available investigation results all support the view that the main mode of transmission was from bird to man and that man-to-man transmission, although it did occur, was inefficient and rare.
The HKSAR Government's decisive action to depopulate 1.5 million chickens and poultry from the territory effectively brought the outbreak to an end. It is crucial that this timely intervention was taken before the virus could acquire the ability to spread with ease among the human population. Complemented with a whole host of measures to ensure a safe supply of H5-free chickens and strict segregation of chickens from waterfowls, HKSAR has been free from human H5 infection. This incident reminds health authorities that the threat of influenza is ever real and imminent. It therefore calls for maintenance of surveillance for influenza in both human, animal and poultry populations.
The influenza A (H5N1) outbreak drives home again the message that the control of influenza is never a local issue; it is a mission beyond any geographical or political boundaries and frontiers. Global support, international collaboration and concerted efforts across different specialties and disciplines have contributed to the success in nipping the problem in the bud. It also reminds us that the constant battle between mankind and infectious agents will continue to be fought all the time and that it is how we act together in unity that gives us the winning edge.
ACKNOWLEDGEMENT
The Government of the HKSAR wishes to thank the many experts in the various organizations and agencies who have contributed their expert advice and time in the management of this incident, particularly to those in the World Health Organization; the Ministry of Health, China; the Animal and Plant Quarantine Bureau, China; the Centre’s for Disease Control and Prevention, USA; St Jude Children's Research Hospital, USA; the Department of Agriculture, USA; the National Influenza Center of the Netherlands; the University of Hong Kong; the Chinese University of Hong Kong; and the Hospital Authority.
1Principal Medical & Health Officer
2Consultant (Community Medicine) 3Deputy
Director of Health
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.
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.