A HOLE IN THE FENCE
By
Dr. Steven A. Smith & Mrs. Lorraine Smith
As
I left the University of Texas Health Science Center building in the
fall of 1982, I couldn’t help but think of all the patients I had seen
that day in the clinic. Many of them suffered from this terrible itchy,
scaly, red skin disease called psoriasis. It was a sorrowful sight
after each patient visit to see the nurse sweeping the floor to dispose
of this trail of ugly, flaky dead skin.
“There
must be a way,” I kept telling myself as I drove home to my family that
night, “to relieve this suffering and pain without prescribing strong
medications, many with severe side effects. We need a treatment that’s
safe, effective and inexpensive.”
Everyday
Lorraine, my wife, would listen intently to my desire to help these
people. Daily we prayed for God to reveal to us the “healing cure”, as
we called it, to psoriasis. Our faith in an Almighty God and prayer to
Him is an important part of our lives.
Then one day in April of 1987, while my wife was in prayer, she felt the words “bromide and nickel”
impressed upon her mind. She was so elated when I came home that
evening. She couldn’t wait to tell me the good news. I just scratched
my head. I had no idea how these two minerals could possibly be
connected to psoriasis. But, we received it with joy as our first
“piece to the puzzle” of finding a remedy for psoriasis.
In
December of 1988, I went to our yearly American Academy of Dermatology
meeting in Washington D.C. The Israelis had a booth in the convention
hall that told about their research going on at the Dead Sea. Psoriasis
patients would come to the Dead Sea from all over the world to soak in
the bromide rich waters and bask under the sun with positive effects.
So
I began extensive library research to formulate a new medicine for
psoriasis. We even visited Israel to see what the doctors there were
doing with bromide. I began to formulate an oral medication of “bromide
and nickel” in very low, very safe oral doses.
In
the several years of patient studies that followed, in the U.S. and
abroad, amazing results occurred. To our surprise, many patients who
had arthritic psoriasis found the formula was helping the arthritis as
well as the skin! Others with psoriatic nail disease began to see
improvement in their nails that had never been clear before. Through
tears people would thank us and praise the wonderful results. We knew
we were truly onto something that could help millions of suffering
people! The patients would beg to stay on the minerals so the problem
would not come back after the test period was over. However, before we
could continue to use the formula, we had to get U.S. Food and Drug
Administration (FDA) approval. So convinced were we that we were onto
something, we filed for a US patent in May 1990. Long hours of
formulation, case studies, charting, examining and comparing before and
after photographs, gave way to a U.S. patent being granted for this
treatment of psoriasis in December of 1992.
Next
we set about to gain FDA approval for our medicine. We had no idea of
the roadblocks ahead, dead ends and astronomical amounts of time and
money involved to meet their standards. Industry averages said it would
take 12 years and approximately $250,000,000 to complete the FDA
process. We wondered “how in the world can two people, married with
three children, come up with this kind of money?” And besides, we
didn’t know any influential people to help speed up the process!
As
with every other move we had taken thus far, we kept proceeding one
step at a time with lots of prayer and never letting the overwhelming
circumstances stop us. If one door was closed, we looked for another
one to open. We spent our entire life savings and sometimes didn’t know
which way to go next. It was our conviction that if we did not give up,
we would find a healing cure for psoriasis.
In
order to proceed with more testing we filed the “IND”, Investigational
New Drug Application, with the FDA in June 1992, and it was amended and
accepted August 20th, 1993. Every time we climbed a major hurdle like
this we rejoiced. Little did we know these preliminary steps were just
the beginning to larger mountains to climb where greater expertise and
larger finances only lurked around the corner.
Now
with the government involved, we needed to proceed through a series of
very expensive tests with labs involved around the country. We had
already satisfied ourselves on the issues of safety and efficacy in
humans, but of course, that was not sufficient for them. The FDA was
requiring at least four larger studies to be done.
The
first FDA study was to be done on animals costing more than $500,000
before we could proceed to several additional human studies. Each of
the next four studies on humans would all take much more time and a
higher price tag to complete. With possibly eight major human studies
going on around the nation costing over $5,000,000, how in the world
could I have time to see patients in my practice, care for my family
and generally “have a life!” We had borrowed money, sold stock in our
new company, LOMA LUX®, and worked every angle
financially available. I guess the system had the best of us now. It
looked like it was over after getting this far. We saw no way out this
time and we were tired of fighting for every inch we had taken thus
far. Words cannot begin to truly express our frustration and feeling of
despair.
We had lifted ourselves up from despair many times before, but this
time not even prayer seemed to help. For months we stumbled around not
knowing how to continue. We just sensed that we were not to give up.
Then the strangest thing happened!
My wife had a dream about being “closed in” on an estate property that culminated in finding “a hole in the fence.” Upon waking she wrote it down and shared it with me.
Well, it took us several months to understand the interpretation. We felt it meant that we were going to find “a hole in the fence”
of the FDA! We took this to be an encouraging dream, even though we
were not sure what the hole would be or where to look to find it.
I
went back to searching out how these low dose minerals, bromide and
nickel in various combinations, could now be safe for humans. Through a
friend, we discovered we had been looking for approval in the wrong
arena! We had not discovered a toxic chemical drug
that would be found someday in the Physician Desk Reference. Drugs
listed there had all been FDA tested and approved – many having severe
side effects. The friend encouraged me to check into homeopathic medicines as a source for approval.
The light came on — we had found our “hole in the fence!”
We discovered in August 1994 that these same minerals, bromide and
nickel, that we had been studying to treat psoriasis, were already
accepted by the FDA in the Homeopathic Pharmacopeia of the United
States! Our wildest dream had come true!!
This
was in keeping with our original idea of a safe, oral, easy to use,
inexpensive, over-the-counter and virtually side-effect free type of
natural medication. With homeopathy as our open door, we began to
design packaging, labeling, and venture into production. We began to
market our product in March of 1996.
Not only did we have our unique psoriasis product to offer, but out of
my research I had identified several unique properties of these
minerals working in the human body. From these observations, subsequent
research and examination of all the homeopathic world medical
literature, we produced five unique oral medications for chronic
diseases that would sell over-the-counter and two prescription products.
We have oral products for skin related conditions Loma Lux® AcnePill, Loma Lux® Psoriasis, Loma Lux® Eczema, and two other products that have since been discontinued. These products are unique in that they all work from the inside-out.
Little
did we know that we now faced the tallest mountain yet to climb –
marketing! Naturally we thought we should go exclusively with health
food stores. We found out that Homeopathy is very big in Europe and
around the world, but the United States hasn’t quite made the full
circle back to natural medicine.
Having
met with failure and roadblocks in the health food stores, we turned to
the mainstream approach of drugstores and pharmacies. Our advertising
began in newspaper, radio and even local television. Our distribution
increased and Loma Lux® products have now been sold nationwide through amazon.com and drugstore.com.
Since the year 2000 we have advertised Loma Lux® products
on top national radio networks. (ABC Radio Network, Premiere Radio
Network, Dial-Global, & USA Radio Network) Loma Lux® radio
commercials have aired on these programs: Dr. Laura Schlessinger, Rush
Limbaugh, Sean Hannity, Satellite Sisters, Casey Kasem American Top 40,
Dr. Dean Edell, Carson Daley, Tony Snow Show, Live with Alan Colmes,
Michael Savage Show, Laura Ingraham Show, John Tesh Daily Show, Gospel
Traxx – Walt “Baby” Love, Dr. Joy Browne, Dr. Ronald Hoffman, FOX Radio
News & Information, and Point of View. National Print ads in these publications: USA Today, CosmoGirl, Teen Vogue, ElleGirl, Cosmopolitan, J-14, M, Twist and several local newspapers in major cities.
Our export and international business is expanding. Loma Lux®products
are sold in Russia, Belarus, Ukraine and South Africa. We are in
contact with several other foreign countries, and working with
individuals interested in marketing Loma Lux® in their country. Getting
registration in these countries requires patience.
With all the sales excitement for our over-the-counter Loma Lux®homeopathic
products, further research and development was focused on the disease
that captured my heart, psoriasis. My desire was to develop a stronger
formulation, and in 1998 I developedPSORIZIDE ULTRA® marketed by prescription only and indicated for eczema and seborrhea. It was also originally indicated for psoriasis.
Three years after PSORIZIDE ULTRA® was introduced, I formulated an additional psoriasis prescription product called PSORIZIDE FORTE®. It combines our original unique minerals with a new natural ingredient “Fumaric Acid”
for patients with more difficult psoriasis. In 2005, we released these
new medications: Acunol for adolescent and adult acne and Eczemol for
eczema, particularly in the pediatric population. Visit www.PlymouthPharmaceuticals.com for more information.
Since
the year 2000, we have promoted our prescription products at several of
the largest medical tradeshows in America: American Academy of
Dermatology (AAD), Academy - mid year (AAD) American Osteopathic
Association (AOA), The American College for Advancement in Medicine
(ACAM), Anti-Aging tradeshows, several state Osteopathic tradeshows and
natural product tradeshows. Print advertising in: Journal of American Academy of Dermatology (JAAD), and the National Psoriasis Foundation’s publications.
Now
in the twenty-first century, we are still breaking new ground, updating
our company websites, and going into uncharted territory daily with
targeted online advertising campaigns, email blasts, building direct
databases for direct mail, print ads in magazines and newspapers, and a
growing staff to manage. LOMA LUX® continues on a path
of success, determined to succeed. We have always had a lot on our
plate with a bursting dermatology practice, a growing family with three
wonderful children, a son-in-law and daughter-in-law, and now
grandchildren, plus many thriving church activities. However, as we
have been faithful to this quest and followed through on details, never
giving up and never taking no for an answer, LOMA LUX® OTC
products, and our prescription products under the name Plymouth
Pharmaceuticals Inc., we have helped restore health to hundreds of
thousands of people bringing them a better quality of health at
affordable prices. God has always honored our efforts and helped us
deliver wholeness to the body through our... “hole in the fence!”