The Pain and the Spin Stops Here

By: Gerald A. Bruno Ph.D.

February 3, 2010

The following is an account of the commercial development of a totally different approach to dealing with the pain and stiffness associated with osteoarthritis (OA). When this story began, the only available options were trying the glucosamine/chondroitin supplements or opting for a surgical joint replacement. Ten years later, these are still the options promoted by mainstream medicine, along with periodic intra-articular injections of hyaluronic acid. As a result of my having to deal with the debilitating effects of OA, and the unattractiveness of the available options, a natural product has been developed and commercialized that offers a real alternative for people dealing with debilitating joint pain.

An Unwelcome Introduction and Intrusion

I was introduced to osteoarthritis about 10 years ago, when I was in my early 60′s. The introduction was subtle and forgettable, a slight stiffness in my right knee after playing a few games of racquetball. Within a few years, the slight stiffness progressed to extreme pain and stiffness after a single game. Not really understanding the nature of the problem and being optimistic that it was a temporary problem that I could “play through”, I succeeded in precipitating a major flare-up that had me on crutches and physical therapy 3 times per week. After an X-ray of my knee, I was told that there was essentially no cartilage between the bones in my knee, and I would have to live with debilitating pain and stiffness until I cried “uncle” and had my knee replaced.

Because of my stubborn nature, and a basic mistrust of medical advice, I continued to walk, run, and play racquetball with the aid of knee braces, routine icing, and occasional NSAID use. I was severely limited in my activities, including entering and exiting a car, and driving for more than 30 minutes without severe knee pain.

At about this time, I became involved with a startup nutraceutical company and had my first conscious exposure to dietary supplements and alternative medicine. The Dietary Supplement Health and Education Act (DSHEA) had been passed in 1994, and many enterprises were being established to capitalize on the rapid growth of this new industry. With a degree in pharmaceutical science and a 15-year stint in pharmaceutical industry research, I saw an opportunity to apply more rigorous scientific scrutiny to the natural substances that could be sold under DSHEA. Despite being well into retirement age, I decided to start a dietary supplement company (Ethical Alternative Products) that focused on natural substances with a strong scientific basis for their use in restoring a healthy balance.

Fish Oil and Rosehips: The Beginning of the Answer

As I immersed myself in the world of natural healing, the constant pain in my right knee served to heighten my attention to articles dealing with osteoarthritis. When I came across a reference that suggested a synergistic benefit to taking a combination of fish oil and rosehips, I immediately started taking these products, and after a few weeks I started to feel a reduction in pain and stiffness. Being sensitive to the possibility of a placebo effect, I shared the remedy with a few friends with knee pain, and they experienced the same improvement in symptoms.

The improvement in pain and stiffness are believed to result from the anti-inflammatory properties of the omega-3′s in fish oil, and the anti-inflammatory and anti-oxidative processes attributable to the vitamins, carotenoids and galactolipids in the rosehips. The apparent synergistic effects of fish oil and rosehips were not explained.

Improving on a Good Thing

Over the next few years, I continued taking fish oil and rosehips, and continued to see the beneficial effect on pain and stiffness in my knee. I also continued my search for other natural joint supplements, and found convincing scientific and clinical evidence that krill oil, collagen type II, and pine bark extract are beneficial in reducing joint pain and stiffness. I tested these substances individually and in various combinations, until a final combination containing the five ingredients was found that profoundly reduced the pain and stiffness symptoms. The biological properties of the krill oil, collagen type II, and pine bark extract were both overlapping and complementary to the actions of the fish oil and rosehips. These ingredients added substantial anti-inflammatory and anti-oxidative activity, and also introduced the lubricating properties of hyaluronic acid (BioCell Collagen Type II contains 10% HA) and the chondrocyte stimulating properties of type II collagen.

It was fully recognized that the sample size was small, but the elimination of pain and stiffness was so dramatic, that it was decided to evaluate formulation of these five substances in a single dose capsule.

Sharing the Answer

The decision to develop a commercial joint health product was based on a large amount of scientific data on the individual ingredients and a small amount of clinical data on the efficacy of these ingredients in combination. A commercial formulation was ultimately developed that allowed the five ingredients to be filled into a single softgel capsule. The commercial product, called OmniFlex, was introduced to the market in mid-2009. Since that time it has been used by a larger number of people, and a broader database of clinical results is being tabulated. To facilitate this process, a special feedback questionnaire (based on the WOMAC osteoarthritis index), was developed and provided to users in hard-copy and website based format. Early returns have confirmed the pre-marketing clinical experience, and include some reports of dramatic reductions in pain and stiffness after taking the product for 2 – 3 weeks.

Lost in the Hype

I recently came across an article in which the CEO of a successful company was quoted as being driven by the motto “after finding the answer, you need to sell the benefits.” I think this is sound advice, but is a particularly difficult task in the natural products marketplace. The natural products consumer is continually bombarded with advertising messages that promise every imaginable health benefit. Both educated and naive consumers are at a loss to decide whether the latest product offering will help restore their health.

In this type of environment, there are two primary ways to gain attention for a product with real health benefits. Both approaches are exceedingly expensive, and generally beyond the financial capability of the typical entrepreneurial enterprise. The first approach involves spending large sums of money on advertising and promotion, so that the product becomes familiar to the consumer after repeated exposure. Since the consumer is generally incapable of separating clinical relevance from pseudo-scientific extrapolation (hype), this approach is commonly employed by enterprises that cannot demonstrate clinical product utility.

The second approach involves spending even larger sums of money to conduct controlled clinical studies, that will hopefully demonstrate the safety and efficacy of the product for the intended purpose. Depending on the intended use, controlled clinical studies can be relatively straight-forward or impossibly complex. Testing products for their effect on joint pain fits into the straight forward category, but can still cost millions of dollars. For example, a 2009 NIH-sponsored multi-center study on glucosamine/chondroitin that involved 1,583 patients at 16 rheumatology research centers cost $12.5 Million. Even though the study concluded that there was no difference between using glucosamine/chondroitin or a placebo, these products are still used by a vast number of people, confirming the effectiveness of expensive advertising.

A Small Step

Lacking the resources or inclination to pursue either of the above methods of “selling the benefits” of our new product, Ethical Alternative Products has chosen to perform a clinical study of the OmniFlex product through participation of the product users in an open-label clinical feedback program. Physicians and consumers who are using the product are being asked to complete a modified WOMAC scoring assessment that will be continuously tabulated and reported to the general public. Progress on this approach has been slow, as users tend to be reluctant to take the time to record their experience over an 8-week period, but will hopefully prove successful as use of the product spreads.

It’s Personal

I decided to take the somewhat unorthodox approach of sharing my personal experience in developing a joint health product, because the product has had a profound impact on the quality of my life. Contrary to conventional wisdom, I have been able to maintain a very active lifestyle, without resorting to surgical replacement of my knee joint. I fully recognize that this story will be perceived by some as another form of over-selling the benefit of a new supplement product, but I challenge the doubters to try the product for 2 to 3 weeks and add your experience to our clinical database. I spent a number of years optimizing the formulation and I am happy to share the answer with fellow sufferers for the expenditure of much less effort.

 

Author Resource:- Gerald A. Bruno, Ph.D. is the Founder and President of Ethical Alternative Products, Wyckoff NJ. Jerry graduated from the Purdue University School of Pharmacy. He has spent considerable time in pharmaceutical industry reserach and also in entreprenurial activities in the healthcare field.
www.gotoeap.com

 

On March 19, 2011, posted in: Articles, Featured Stories by admin