Russet, good post -
First, I want to say that I, too have wondered about the adoption rate, the renewal rate, the market penetration, especially as it relates to revenue ramp-up, and DMX's ability to fund further P2/P3 trials, particularly for WF10.
I'm not at all sure that the sensible questions you raise have a sensible answer: or at least, one that is accessible to us. That should change as more data become available.
Without disagreeing with you, I'd like to suggest that some of the difficulties with possible answers lie in the assumptions with which one starts, and the "semantics" of the statistics one derives.
That is, of the suggested $8 billion market, what percentage of those fall into categories you have defined: ie., cannot find the time or the place to apply a topical, prefer to take a pill, etc.
Unless we know the statistics on those whose usage patterns and predelictions preclude the use of Pennsaid, we have no meaningful starting point. I have been unable to find a statistic for those who answer "Yes" to the question, "Would you use, and continue to use, a topical that brought you relief from the pain of OA?"
The people I have known with OA have "better" and "worse" days. What percentage of these would be motivated to use Pennsaid on a "worse" day, but otherwise, not?
What happens to a drug that gains a place in the psychology of the people, even the less literate? Like cocaine, for example? Or marijuana? Or aspirin? Difficulty in usage, even the possibility of jail, certainly didn't preclude their acceptance, in the first two cases. The pervasive use of aspirin (even when contraindicated or ineffective) has become universal.
"Aha! You say - Pennsaid does not offer the "high" that cocaine and marijuana do! It does not "reinforce" usage." Perhaps, but what are the statistics on reinforcing usage by relieving pain?
Approaching the subject from the other end, the question of creating demand for a product, I'm sure you have seen the statistics that substantiate the ability of effective marketing to do so, whether you're talking Volkswagens, topicals, or Super Mario.
In the middle, of course, is the question of retaining customers, and subsequently growing market share. In this area, you and I share concerns: I have no answer, except that the question of what we are really measuring allows me (if not you) to question the validity of any assumptions made about the statistics.
But there's a counterbalance to this potential loss of market share (if it exists), and that is off-label use of the drug: in sports, in sports medicine, and perhaps in everyday household usage.
In balance, my estimate is no better than yours: I will simply wait and see. Whether, for you, that constitutes sufficient reason to continue your investment is another question.
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On the matter of long-term use, and toxicity, I'm sure you have seen the use of DMSO by Dr. Jacobs in treating scleroderma. I will re-post some of it here, because these patients were not only ingesting DMSO, but simultaneously taking intravenous injections of DMSO, with topical applications of DMSO.
"DMSO Testimony, Janet's Story
by Janet Field
I was diagnosed with scleroderma in May of 1995. In June 1995, I had a seizure and was hospitalized. While I was in the hospital I went into kidney failure and was put on dialysis, which I continued until January 1996. Then my kidney function returned to 26%, so I didn't need to be dialyzed any longer.
In March 1996, I heard about Dr. Jacob and DMSO through a friend and also an article in the Willamette weekly. I decided to go and see Dr. Jacob and he prescribed 1 ‡ tsp. DMSO a day and an injection once a week. After I began this regimen I slowly began to feel more mobile. My face which was tight and drawn began to soften and each week I started to look like myself again. The left side of my jaw had pain (which no longer does) and I had a hard time opening my mouth. The dental hygienist noticed I had more flexibility (while cleaning my teeth) than I had had before using DMSO. My neck was also tight and stiff and it feels a lot better and the shiny skin has gone away. My knuckles and joints in my hands were swollen. Some of this swelling has subsided and my kidney function has also improved to 40%.
Another doctor said that there was nothing anyone could do for me and that I would continue to get worse. Without DMSO I believe I would not have improved. I hope with continued use of DMSO, I will get better and better.
Janet Field
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A Right to Live
Joyce Mueller
Eugene, OR
My name is Joyce Mueller. I am a wife, a mother of two children ages, 16 and 9. I am 40 years old and have a terminal illness called Scleroderma.
The reason I write today is in hopes that no one with this disease will ever have to go through what I did, mentally, physically, or financially. I've had this disease for 13 years now, a very cruel disease. There were times I didn't ever think the pain could get any worse, but it always surprised me, when I least expected it, showing me how powerful it is!! I asked God, Why me, often, but why anyone?
I have seen supposedly the best doctors in the U.S. I've been to the Mayo Clinic in Minneapolis, Sister Kennedy's, Seattle University, and also to Spokane's Deaconess Hospital. Not to mention, that I had exhausted all of the doctors and clinics in the state of Montana, where we lived at the time.
My heart and lungs were calcified, my esophagus had to be reopened three times, and I was having trouble with my stomach, bowels, and intestines. My hands and legs were so tight they didn't bend anymore. Hands so crippled up I couldn't bend my fingers well enough to button my clothes or fix a dinner; just holding a cup of coffee became a challenge. I slept maybe an hour or two out of twenty-four, and I soon learned all I had taken for granted was quickly being taken away. My kidneys and bowels were shutting down, and the doctors had given me three months to live, if I was lucky. They could give me more medication for the pain, but, I quote, "this is a terminal illness and you will die from it, there is nothing we can do for Scleroderma, so accept it."
Many sleepless nights and tears that never seemed to end. I knew I was dying, not able to see my children graduate from even elementary school, knowing I would never see who they married, or my grandchildren. The doctors had finally convinced me; they had raped me of any pride or hope that I had kept locked inside. Depressed and too tired to keep fighting this never ending battle, I kept thinking, why isn't there some drug that can make me well again; why don't I have a right to live?
That was three years ago. I'm trying to make a long story short here, so please bear with me. My husband went over to the neighbors to prune her trees for her. She had asked him what disease I had, (she had seen him have to help me walk even to the car). He said, "Scleroderma." She told him of a woman who had the same disease who lived a couple of blocks away, and she was seeing a doctor in Portland, Oregon, who had her in remission. This was something you never heard of, remission and Scleroderma all in one sentence.
I went to Portland Oregon, to see Dr. Stanley Jacob! He wasn't sure at first if he'd be able to help me or not, but I thought even if it could help the pain a little bit, it would be worth it. I knew I was dying, and this was my last hope.
He started with giving me IVs of DMSO every day for two weeks, plus gave me an oral to take and a topical solution to put all over my whole body. It was incredible!! Daily I noticed very small changes, but progress. The pain wasn't so severe, and gradually my hands and back and legs seemed to be a little more limber. When I got off the plane two weeks later, my husband and kids didn't recognize me. I could walk like a normal person again!! And excited beyond words, he had given me hope, something that I had not had for a very long time. Dr. Jacob gave me back my life.!! After that I couldn't find a doctor in Montana to give me IVs of DMSO.
Yes, you're right, we sold everything we had and moved to Oregon, leaving my husband's job of 13 years and all of our family and friends. It took about a year, a very slow progression, but an uphill climb. Three IVs a week, plus the oral and topical. But, for the last two years, I am happy to say I've been put into remission!!! Not only has it helped the pain, (I still have about 20% left, reminding me that I still have this disease), but my hands now look normal and my face and skin looks healthy once again.
The calcification in my hands, heart, esophagus, and lungs are gone. All of the CAT scans, and heart and lung tests are totally normal. The heart specialist told me if he hadn't read my chart, he wouldn't have believed I even had Scleroderma.
It took time to come off all the medications, about 9 months to a year. And that first year it took time to heal the intestines (the inside lining was tearing each time I had a bowel movement). But I am now only using DMSO, and doing great. I had years of damage done to my body; it took a long time to get this bad. And it is taking time to change the damage done; it hasn't happened over night, but it has happened!
I feel like I've been given another chance in life. I can now lead a normal life once again. I can now look forward to each day instead of dreading the pain that I would normally go through. My kids don't worry anymore while they're in school if they'll come home to me dead or alive. My husband doesn't worry anymore if I'll be around for the next anniversary. I watched him for years, feeling helpless, wanting so much to be able to change what this disease had done to me, to us. He had truly been a saint through it all.
I thank God, the DMSO, and Dr. Jacob for giving me back my life again, a fully productive life that I look forward to. I just hope by writing this, that it will help someone else to fight this disease. There is hope. This may not be a cure, but I believe at the present time it's the closest thing we'll find. I've learned a lot through the years. The things I took for granted once were taken away. I have learned to enjoy life to its fullest, and be thankful for all things. But, most of all, I have learned to never give up, no matter what the odds. All of us, have a right to live.....
Stay well and God bless,
Joyce Mueller
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A DMSO Testimony
by Rob Rabinowitz
Holland, PA 18966
In 1988 I began to feel changes in my skin and joints. After going to three different Doctors, I was finally diagnosed with Scleroderma. In the year and a half to follow, I was on at least four different medications. Nothing seemed to work and the disease was pro-gressing rapidly. My skin was very tight and I had trouble walking and eating. I went from 170 pounds down to 139 pounds. At this rate I knew I was in trouble.
In January 1990, I heard about Dr. Stanley Jacob, MD who had a clinic in Portland Oregon. I lived in Pennsylvania and decided to fly out to Portland. Over the next two years I flew out to Portland and received treatments of DMSO intravenously. At first nothing happened so they began to give me double doses of DMSO. Finally, after about nine months (three treatments a week) I began to feel a change. My skin softened and my weight and stamina increased. My weight increased to 170 pounds again and I began to feel human again. I still have Scleroderma and still have relapses. However, since taking DMSO, I believe it allows me to function as close to normal as I can feel. DMSO is not a cure but DMSO helped to turn my condition around.
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