Prevention: The Issue of Heart Disease
By: Dr. Fred D. Sancilio, MS, PH.D.
We go through life preventing problems that can harm us. We buckle our seat belts to prevent unnecessary injury should we have an accident while driving, we wear hard hats when working in construction sites and we carry life jackets on boats to prevent drowning but what do we do for our health?
Many of us realize that our diets are the first defense against some common diseases. We’re told to eat vegetables, avoid fatty meats and limit carbohydrates to stay healthy. But our western life style continues to provide just the opposite. Most of us eat few healthy vegetables regularly, we consume far more meat then we should and eat tremendous amounts of carbohydrates in the form of breads, rice and confectionaries. The fact is that most of us cannot modify our diet and we are consuming the wrong foods. As a result we tend to be overweight, deficient in certain nutrients and have a growing number of people tending toward diabetes and heart disease.
Most pharmaceutical companies focus on the end result, the disease itself and not the prevention of the disease. The federal drug regulations have all been written to help develop medicine to treat disease. There are clearly defined clinical methods to prove that a drug will impact an existing disease. These clinical trials are extremely costly but will nearly eliminate doubt that a drug will cure (or impact) a disease. Such a clinical trial to show a medicine will impact cardiovascular disease may take more than 5 years and cost over $100,000,000! While this amount of money may seem tremendous, it is within reach of established drug companies and is routinely spent for research of new medicines. A new drug will cost a pharmaceutical company nearly ONE BILLION DOLLARS to develop and provide clinical data to the FDA.
However, to prove that a substance will prevent a disease or health issue is very difficult and not as well defined. There isn’t a feasible set of regulations that allow claims to be made for a medicine that may prevent a disease. A clinical trial seeking US FDA approval using current regulations would require tens of thousands of people, dozens of years and nearly a billion dollars of investment per trial. Thus, most medicines that may prevent disease are not approved drugs and probably will never be.
There have been thousands of scientific investigations published that report health benefits of two essential fatty acids found in nature. EPA and DHA (both Omega-3 essential fatty acids) are well documented in the scientific literature to reduce unhealthy levels of triglycerides and are strongly recommended by the AHA to improve cardiovascular health. Both of these nutrients are found in fish and algae and have been sold as supplements for over a century without FDA approval. In the past decade, two US drug companies have been given marketing authorization by the US FDA and are now allowed to make a label claim that these old essential fatty acids can reduce very high (disease state levels) of triglycerides. These companies spent hundreds of millions of dollars to meet federal regulations and perform controlled clinical trials to be able to claim what is an already established health benefit known for decades. While unapproved supplements of omega-3 can sell for $0.30/capsule, the approved “new” drug must sell for $2.00/capsule to enable the pharmaceutical company to repay their investments. Hence, the consumer will pay the additional $1.70/capsule (keep in mind that 4 capsules/day are normally taken) for clinical studies that were more of a formality than a necessity.
Legislation is needed to provide an alternative and cost effective method to gain marketing authorization of preventative medications like the Omega-3 noted above. There are dozens of other similar substances falling into this category. In most other western countries, regulations address this by having a “special” supplement category; lying between drug and supplement. These special supplements are registered with the government and approved using published information and do not require additional clinical testing. There is no equivalent category in the US. In fact, supplement producers are not required to register their products at all!
What I believe is needed is a new set of regulations that assures the quality of supplements and in those cases where there is well documented preventative treatment use, requires the company to provide an application for “special supplement” status containing chemical, manufacturing and controls information and well written documentation for its use as a preventative. In this way, a lay person can read an approved label for these preventative medicines, be assured that the material has been inspected by the US FDA, and can afford to provide themselves ways of preventing future medical problems. As it is today, the consumer can only scan the literature on the internet and hope that the manufacturer provides supplements with consistent, high quality ingredients, keeping in mind that nearly all supplements available in the US originate outside of the country. The latest estimate is that over 85% of supplements sold in the United States are made in China and India with a growing percentage from Viet Nam. These manufacturers are not inspected by the US FDA and may produce these products with questionable quality and ethics.
In conclusion, preventative medicine is a necessary way that people can use to treat a disease before it takes its toll. However, a new set of regulations is required to assure the public that these medicaments are made with quality and are indeed appropriate to prevent a future illness. Legislation is also needed that allows sponsors of these medicaments to explain to consumers how the products work and how to administer them. Today, it is illegal for companies to explain the use of preventative medicines and nearly impossible to gain FDA approval for known beneficial substances. As a result, people who could have prevented illness will not and will suffer needlessly.
SCI Creates Jobs and Expands into Global Distribution
January 1, 2013 Riviera Beach, Florida – Sancilio & Company, Inc. continues to expand its research, development and production operations to support several new global initiatives. Domestic sales of its Ocean Blue® Professional Omega-3 products continue to expand into major pharmacy chains throughout the United States. Dental and women’s health products are now available throughout the country and can be found in both chain and independent pharmacies supported by all of the major wholesalers.
Demand for SCI’s products has recently expanded into the global marketplace. The Ocean Blue® brand is now the 3rd largest omega-3 product in Italy and Germany. The product line also launched in Korea in the third quarter of 2012. Additional product launches will include Canada, Poland, Spain and the Philippines following regulatory approval by the local governments. Dental fluoride products are targeted for launch in Brazil, the Philippines and the UAR.
The company also expanded their soft gelatin production facilities at the end of 2012 in Riviera Beach, Florida to support the global initiative. As a result, the company has added dozens of new positions and continues to seek high quality talent in pharmaceutical science, analytical chemistry, production and sales.
The Genesis Clinical Investigational Program Is Complete
November 14, 2012, Riviera Beach, Florida – Sancilio & Company, Inc. has completed its clinical trial of its dietary supplement to lower triglyceride. The results of this study are published online at Scientific Research (http://www.scirp.org/journal/fns/). The study clearly confirms the efficacy of the Ocean Blue® Professional Omega-3 2100™product in lowering triglycerides. The company has used this data to design three additional clinical programs that will be conducted following IND submission to the US FDA later this year. SCI expects to complete the Phase I and Phase II programs by year end. An additional IND has been filed with the US FDA to investigate the use of Ocean Blue® Professional Omega-3 2100™ in diabetic patients.
