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Lab Space |
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Edward Siguel, MD PhD |
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PO Box 10187 Dept E, Gaithersburg, MD 20898 TO: Laboratory or Medical Director
Dear Laboratory Director: I specialize in the diagnosis of conditions resulting from abnormal levels of Essential Fatty Acids (EFAs). I developed a patented method to diagnose lipid and fatty acid abnormalities, as well as new nutritional treatments for hyperlipidemia and other health conditions. I am interested in collaboration to implement a center for the diagnosis and treatment of fatty acid and lipid abnormalities, including one or more of the following components:
Hyperlipidemia and low HDL I have identified one of the most significant nutritional factors associated with TC/HDLC and cardiovascular disease. I have also developed a nutritional therapy that lowers TC/HDLC far more than existing dietary therapies or many drugs (perhaps by as much as 50%, based on ongoing tests). I have identified a biochemical "defect" which could account for low HDL in a significant percent of the population. I have a treatment that would probably correct the problem (research under development, drug and treatment under development; patent being written); it increases HDL and/or decreases triglycerides. The commercial value of my diagnosis and treatment method could be substantial. It is difficult to put a dollar value on treating a problem affecting more than 50 million Americans and which is probably the most significant cause of morbidity and mortality. I estimate that the market for diagnosis and treatment of low HDL in the USA alone should exceed $1B/year, but it is probably closer to $10+B/year. Patients with abnormal lipids account for many cases of premature heart disease. Premature heart disease is one of the most expensive medical conditions to treat, accounting for tens of billions of health care dollars. Diagnosis and treatment of EFA abnormalities My data indicates that EFA abnormalities affect more than 30% of the US population. At least 5% of the total population have severe abnormalities that require immediate treatment. EFA abnormalities may lead to impaired neurological growth, increased platelet aggregation (i.e., clot formation), cardiovascular disease, and a variety of other complications. In patients with fat malabsorption (i.e., Crohn's disease, short bowel syndrome, Cystic Fibrosis), I can identify treatable fatty acid abnormalities in more than 90% of samples evaluated. My research has shown that physicians have vastly underestimated the extent of EFA abnormalities in these patients. Even those who receive lipid IVs have significant EFA abnormalities (supporting data was found by Dr. Wilmore et al. and presented at ASPEN, 1995). See publications. I would like to use my patented blood test for the diagnosis and treatment of fatty acid abnormalities. My test is discussed in my book and publications. The financial arrangements are flexible. I can provide initial funding and obtain additional capital to purchase equipment and hire personnel, hire individuals to contact and speak with physicians, present the test at professional meetings, etc. I can also provide your organization with a license for my patented test and instruct your laboratory on how to perform the test in accordance with my procedures. I can license my software programs for preparing test reports and diagnostic graphics. My test is highly complex. I have unique procedures for extracting fats from blood, analyzing them with gas chromatography, and quantifying each specific type of substance found. I currently separate more than 300 chemicals. About 35 are fatty acids that I routinely report to physicians. The rest are various substances that I am investigating as markers for different disease states. It takes more than 10 hours of labor to do one analysis. My experience indicates that the clinical cost (charges depend on the profile ordered), is reimbursed by insurance carriers and it is cost/effective for the patient and the insurer when compared with merely diagnostic tests that cost more than $2,000. For example, patients often pay more than $2,000 to diagnose a partial coronary artery obstruction, when the diagnosis does not reveal the biochemical basis for the obstruction. My test provides a diagnosis and indicates the optimal treatment. As a result of my research, the demand for fatty acid analyses may increase dramatically, including testing for deficiencies and imbalances of EFAs and measuring amounts of trans Fatty Acids (TFAs). Measuring TFAs will become more important over time as more research is published linking high levels of TFAs to a variety of abnormal health conditions (research has shown that TFAs contribute to more than 30,000 premature deaths per year). Based on my research, at least 40 million Americans have biochemical abnormalities of EFA metabolism that ought to be diagnosed and treated. Another 50 million should be evaluated for elevated TFAs and omega-3 deficiencies. At least 5 million people (for example, patients with Crohn's disease, Cystic Fibrosis, Short Bowel Syndrome, etc) have severe abnormalities of EFA metabolism and should be evaluated at least twice per year and treated with high doses of EFAs to prevent deterioration leading to expensive medical care. The potential for diagnosing and treating EFA abnormalities exceeds $1B per year. Food companies I am interested in designing EFA-rich foods. For example, I am now working on the design of eggs to lower Total/HDL cholesterol and triglycerides, chickens that would prevent or treat heart disease, and food supplements to correct EFA abnormalities. I developed a chocolate pudding and a dessert that can lower abnormal cholesterol levels. I would like to assist companies in incorporating my nutrition recommendations in brochures to be distributed across the country. I will also be training physicians and nutritionists on my treatment approaches, either through my own publications or through materials distributed by other organizations. Publication of my findings My research has generated significant excitement in my field and has led to frequent publicity, such as coverage by CNN, National Public Radio, national professional and lay newspapers, and magazines. In 1994, the American College of Cardiology selected my presentation to call a press conference to announce my results on the role of EFAs in TC/HDLC. In 1994, I published a paper in the journal Metabolism which shows that EFAs are the "missing link" between nutrition and heart disease. I have developed a new classification of abnormalities of EFA metabolism. In the future, I expect to publish similar studies linking an imbalance of EFAs to chronic gastrointestinal disease, hypertension and diabetes, based on research currently near completion. An exchange of letters between the USDA and myself is published in the Am. J. Clin. Nutrition (Sept 1995), as a follow-up to my previous letter in the Am. J. Clin. Nutrition (Dec 1994). These letters recommend a change in USDA nutrition policy and the USDA food pyramid and talk about the role of vegetable oils (rich in EFAs) to supplement low-fat foods. My research indicates that incorrect application of nutrition recommendations is causing millions of people to eat high-calorie foods deprived of EFAs. Current policies emphasizing low-fat foods are widely misinterpreted and will require changes in nutrition education policies. My recommendations for biochemical diagnosis and treatment have been distributed to more than 10,000 physicians, both in the USA and abroad, as part of an audiocassette series of educational materials for physicians. They have also been distributed via scientific conferences and published scientific articles. My message on the need for EFAs has reached more than 10,000,000 people since 1994 (based on the estimated audience of Time magazine, The New York Times, The Chicago Tribune, The Boston Herald, Self magazine, Longevity magazine, Family Circle, Your Health, Modern Medicine, Vegetarian Times, numerous other publications, CNN, TV, and many syndicated radio shows across the country). Between trade shows, radio and TV interviews, magazine articles, and scientific conferences, I expect to reach > 1M people this year. I believe that my activities could lead to better utilization of your facilities. Fat is the #1 food concern of American consumers. Government and public health agencies agree that fat is probably the most significant nutrition issue in health and disease. Using foods rich in EFAs to prevent and treat cardiovascular disease, high blood pressure, abnormal cholesterol levels, and other health problems would save billions of health care dollars and improve the well being of most Americans. EFAs are a hot topic. At recent food trade shows, I was voted one of the best speakers and had one of the largest audiences. During my lectures, many health practitioners tell me that they want to incorporate the new knowledge into their practices and want to test for EFA abnormalities. The public is becoming enlightened about the role of EFAs via articles that are being published in the popular and scientific press, as well as via my lectures. The result has been a large increase in food supplements rich in EFAs and the design of many new food products. My objective I am looking for an organization that is interested in becoming a referral laboratory. The institution may also be interested in treating patients for diseases associated with fatty acid abnormalities. As an incidental benefit, the institution may expand its number of patient visits in the areas of inflammatory bowel disease, fat malabsorption, neurological disorders, hyperlipidemia, hypertension, and diabetes. The organization will provide the laboratory space. I (alone or in collaboration with the organization) will provide the equipment, methodology, marketing and professional relations. Institutional reimbursement will depend on the nature of services provided. I spent several years developing and testing the laboratory methods, reports, software, reimbursement rates, and various other aspects of the test. Now I need help to make my test available to physicians in the US. I would appreciate very much your help in these matters. Please let me know if your organization is interested or you can refer me to an institution that is interested. Thank you very much for your consideration. Sincerely yours,
Enclosures: See Efalab for brochures, etc. See Siguel's curriculum. Contact us. Serious inquiries only, please. You may reproduce this letter, which is written in my personal capacity. Personal or research references will be provided upon request. Users (physicians) available upon request or in published results. This letter contains only my opinions or projections on the issues herein described. This letter is not an offer which can be accepted into a contract (too many issues need to be resolved) and does not imply any promises or guarantees regarding the outcome of any particular diagnosis or treatment method. This letter is not intended to provide diagnosis or treatment advice. No representations, either express or implied, are made or given regarding the medical or business consequences of opinions herein presented or the estimated future income. This is not a solicitation for funds or investors. |
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All information on this website is copyrighted; see use and permission to reproduce. The information in this website is not medical advice, merely a general scientific discussion. See warnings & disclaimers. |
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© 1998 Edward N. Siguel. All rights reserved |
modified 9/16/98 |