It is my opinion, to a reasonable degree of medical certainty, based on all of the materials I have thus far reviewed, on my training and on my 43 years experience as a medical examiner, that Mr. Bechler died of a heat stroke precipitated by his morbid obesity, high blood pressure and heart disease, adverse weather conditions, physical exertion, and inadequate screening, monitoring and medical supervision; that Xenadrine did not cause or contribute to Mr. Bechler's death; and that proper and prompter treatment with intravenous fluids and cold wraps immediately after he collapsed but was still conscious may have prevented Mr. Bechler's death.

It should be highlighted that the death of Steve Bechler is the first time ephedra has been blamed as the cause of a fatal heat stroke. There is no report of heat stroke associated with ephedra in the Cantox Report or the RAND Corporation report or found in the online medical libraries. In literally dozens of studies, ephedra-based products have been shown to be safe when used properly.

To prevent future or similar type tragedies should be the real focus of all of us here. This focus will be lost by improperly seeking to lay the blame on a supplement or an industry while ignoring the real factors that caused or contributed to the tragedy, such as improper medical screening, training, and treatment by the Baltimore Orioles. It is our hope that when the true factors come to light proving ephedrine was not the cause of Mr. Bechler's death, that appropriate and reasonable measures will be taken to prevent tragedies like this in the future.

I take the subject of dietary supplements very seriously. I became involved in the supplement industry because I have used the products myself and have experienced their benefits firsthand. After seeing the benefits, it became my passion. I have personally taken ephedra and caffeine products, including our Xenadrine RFA-1®, and it was effective for me. My wife, our family, and many of our friends have also taken and enjoyed the benefits of Xenadrine RFA-1®. Over time, our product became one of the most successful in the dietary supplement industry. Our company has received inspiring feedback from tens of thousands of people who have lost weight and have improved their quality of life using Xenadrine RFA-1®.

In the early 1990's, I worked for a company that sold an ephedra-caffeine product. I was encouraged as I listened to our customers, who were struggling to lose weight and found the ephedra-caffeine combination products very helpful. Weight loss is difficult. America's weight problems are steadily getting worse.

The Centers for Disease Control has posted on its website some very powerful statistics that show Americans are increasingly overweight. As of the year 2000, the prevalence of obesity among U.S. adults was 19.8 percent, which is a 61 percent increase since 1991. In 2000, 38.8 million American adults could be classified as obese, defined as having a Body Mass Index, or BMI, of 30 or more. Between 2000 and 2001, obesity climbed from 19.8 percent of American adults to 20.9 percent of American adults. Currently, more than 44 million Americans are considered obese according to the BMI index; that is, they have a BMI greater than or equal to 30. This reflects an increase of 74 percent since 1991.

Fighting this struggle is emotionally difficult for many people. When something works, it makes a meaningful difference in their lives. That is why, after the first supplement company I worked for was sold, I researched many different dietary supplements and reviewed scientific literature preparing to market a new weight loss product that provided meaningful benefits. Based on the volumes of existing research supporting its safety and efficacy, it seemed clear that a product centered around the ephedrine-caffeine combination offered the best potential.

Those numerous clinical studies showed what we still know today, that the ephedrine-caffeine combination is one of the few combinations that help people lose weight.

Cytodyne Technologies started out as and remains a small business. We had until recently ten employees. The good men and women of Cytodyne Technologies involved in marketing Cytodyne Technologies' products did so responsibly, in the firm belief that Xenadrine RFA-1® was safe and effective when used as directed. We took seriously the scientific and other information we learned as we marketed Xenadrine RFA-1®, and relied as appropriate on experts and scientific studies. To develop and make Xenadrine RFA-1®, we hired a very reputable manufacturer, run by an experienced pharmacist, that has manufactured hundreds of other nutritional supplements. I was personally familiar with this manufacturer and their expertise from my experience working in the dietary supplement industry. Their products were well-regarded. We felt that this company stood out because they were licensed to make over-the-counter drugs, followed good manufacturing practices, and had a higher level of attention to quality control and a higher quality of product overall.

Although we relied initially on the clinical studies of the ingredients ephedrine and caffeine, we took a more conservative approach than utilized in those studies by implementing a substantially lower dosage of ephedrine and caffeine than what was used and shown to be safe in those studies. Our label included the most comprehensive warning language and went even beyond industry standards. It warned customers to consult a physician before using if they were at risk for certain specific conditions.

We commissioned product-specific studies in marketing our product. Product-specific studies are not required of our industry and many of our competitors -- most have not done them. We took that step, though, a total of seven times. We think we helped start a trend in the right direction and our tests demonstrate our efforts to be responsible. These were independent, product-specific, double-blind, randomized, and placebo-controlled (or, in one case, compared to a prescription product). The results were accepted for publication and published in abstract form or full-length reports in well respected, peer-reviewed scientific journals such as the International Journal of Obesity. In each study, Xenadrine was shown by statistically significant data to be effective for weight or fat loss within the confines of the study. These studies were also designed to measure certain specific safety criteria, such as vital signs, blood chemistry, blood pressure and EKGs. submissions be made a part of this record.

We retained and relied on various experts, such as a medical doctor, Ph. D.-level nutritional researchers and exercise physiologists, as well as other professionals, such as regulatory counsel who reviewed our labels. We engaged Dr. Carlon Colker, a respected physician, as a consultant after his firm, Peak Wellness, completed the first scientific study on Xenadrine RFA-1®. We wanted someone with his high level of knowledge and background as a consultant. He provided guidance on a number of technical issues, and kept us advised of developments in research and in the dietary supplement industry.

When we received our first complaint alleging a serious adverse health effect, in June of 2000, I asked Dr. Colker to work with our company and the customers to learn about such complaints and act as a referral source so that we could better understand the information. We believe we are the only company that used a medical doctor in this way.

Many stories in the press have focused on customer complaints, as opposed to scientific studies, to allege that ephedra causes serious adverse effects. Although Congress has not required companies like ours to document or report complaints, we did adopt a policy and practice to record and preserve that information. We had a policy and practice in place that any customer complaint of an adverse health effect was directed to Mr. Conklin, who reported directly to me. Our policy was to tell any customer concerned about adverse effects to stop taking our product and seek medical advice, and we offered the services of Dr. Colker as a referral source. We distinguished ourselves from many other companies by having this system.

When asked by the Food and Drug Administration to respond to Adverse Event Reports, we asked Dr. Colker to help us prepare the responses. Dr. Colker gave us his assessment of information he received about customers who called him with medical complaints, and he did not conclude that Xenadrine caused any serious adverse health effects.

Cytodyne Technologies was advised and believes that the complaints are anecdotal and do not indicate that Xenadrine RFA-1® was unsafe, or caused any serious adverse effects for several reasons. Customer reports are well-known to be unreliable for scientific reasons. The General Accounting Office has issued two reports, one in July 1999 and one earlier this year, concluding that adverse event reports and customer call records do not prove cause and effect. Over almost five years, we received a very small number of complaints compared to the volume of our sales. We sold over twenty million bottles -- over a billion servings -- but we received only about 450 complaints, including many during the recent months of great media attention. The great majority of those complaints were for transient, mild side effects.

We always took customer complaints seriously. Since I started this company, I have listened closely to customer feedback, both negative and positive. We never had any reason to believe that Xenadrine RFA-1® caused anything but mild, transitory effects. We believed this because we relied upon professionals and studies.

During the time we were selling Xenadrine RFA-1®, we did not become aware of any reliable scientific studies finding that there were safety problems with ephedra products. Rumors, news stories, and unscientific information began to circulate with greater frequency, but we did not find that kind of information reliable, nor did our medical consultants.

Instead, the available science confirms that ephedra is effective and safe when properly used. A major report by Cantox Health Sciences International on the safety of ephedra-based products contained a comprehensive risk assessment. The Cantox report conducted a thorough review of the available study literature and established that ephedra is safe when used properly according to industry recommendations. The recent RAND Corporation report also confirms that ephedra works for mild to moderate weight loss. The RAND Corporation concluded (like the General Accounting Office did) that adverse event reports are not reliable to support any conclusions about effects caused by dietary supplements. The RAND Corporation report concluded that there is insufficient evidence to conclude that ephedra poses an imminent health hazard and that further studies need to be conducted.

In comparison to the complaints relating to adverse effects, we received thousands and thousands more responses from satisfied customers praising the benefits of Xenadrine RFA-1®. We sent out and received back tens of thousands of customer satisfaction survey forms, and only a tiny number of them mentioned any dissatisfaction or adverse effects.

We also welcome a chance to respond publicly to news about a recent ruling in a class action lawsuit against us in California. We were surprised and dismayed by the California state court's decision because the judge in that case disregarded the rulings of a federal judge in Utah in 2000, who found the same advertising claims challenged in California were true and not misleading. That federal judge conducted days of hearings and heard the evidence. He approved the reliability and competence of Dr. Colker's clinical study on Xenadrine RFA-1®. Naturally, we relied upon that decision in believing that our advertising was legal, true and not misleading.

Another major error, we believe, in the California case was the total lack of any evidence that the public was misled. There was no evidence concerning what consumers took away from our ads, nor that consumers were misled. It is our position that the judge substituted his personal opinion for hard evidence. We believed, and a federal judge ruled in our favor, that our advertising claims were true and not misleading. We will appeal this decision and we are confident that it will be reversed.

We are just as hopeful that this Subcommittee will fairly consider the information we have presented and be guided by the reliable scientific information and not be caught up in the media hype.

The truth is that ephedra supplements have been used by tens of millions of people in recent years. Unfortunately, with a population this large, there is an expected number of medical problems that will always occur whether those people used ephedra or not. It is not appropriate simply to blame ephedra every time someone in that population experiences a problem. It is unfair, unscientific, unreliable and is an injustice to the right of the American people to make their own choices. The debate over ephedra has become a circus, and to decide the future of dietary supplements in a media frenzy would be irresponsible. We are relieved that Congress is stepping in and we are confident that the appropriate responsible steps will now be taken to resolve the issue of the safety of ephedra.

As this Subcommittee continues its investigation, I hope that the massive amount of information we have already provided to you and your staff will be helpful, and I look forward to answering your questions.