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. 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. We have oral products for skin related conditions Loma Lux® AcnePill, Loma Lux® Psoriasis, Loma Lux® Eczema, and two other products Loma Lux® Asthma, and Loma Lux® Sinus & Allergy. 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 in the the largest drugstore chains and mass merchandise stores in America. Walgreen’s, Eckerd, CVS, Rite Aid, May’s, Med-X, Drug Warehouse, Drug Mart, Target and several Wal-Mart’s. 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 developed PSORIZIDE 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. Visit www.PlymouthPharmaceuticals.com. 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!” |