Whole Foods Magazine
February 2002

The Coenzyme Q-I0 Breakthrough:
Part 2: Repression of CoQ Heart Failure Research

An Interview with Dr. William V. Judy

By Richard A. Passwater, Ph.D.


In this issue, we continue our discussion with Dr. Bill Judy to see why mainstream researchers are getting very excited about coenzyme Q10 (also known as CoQ or CoQ-10). What has changed their viewpoint from that of CoQ being merely an obscure nutrient having both bioenergetic and antioxidant activity to that of having major health benefits as a legitimate dietary supplement? We considered these questions in our last installment and hinted that some of the new excitement is generated by a combination of the latest findings in heart disease, low-energy syndromes, cancer prevention and treatment, new discoveries in neuro-degenerative diseases, stabilization of the nucleotides in protein synthesis, and low energy syndromes and poor physical and mental development in genetic syndromes.

Nevertheless, that first installment also indicated that the CoQ story is replete with research efforts denied, doors shut, studies sabotaged, publications refused and jobs lost. Joyously, we said then and repeat now, the lid of repression is about to be blown off.


Passwater: Dr. Judy, allow me to me to do a quick recap of the ground we covered last month. Your research was not embraced by the medical community. This is another flagrant example of what Wayne Martin described as the "blood-caked frock coat effect" in three recent columns. Wayne wrote a marvelous book, Medical Heroes & Heretics, in which he discussed several classic instances wherein the medical profession's reluctance or refusal to accept new facts has caused countless deaths. This is another classic example. You had preliminary results that were very exciting with CoQ and cardiac congestive heart disease, yet you were asked to stop this research.

Judy: That's right.

Passwater: From the sound of it-location, funding sources, competing research, etc.-I would guess it was likely that a drug company was behind having your first research efforts squelched.

Judy: I believe this was very likely. Both Drs. Folkers and Langsjoen had warned at a meeting in Germany that my position relative to continuing CoQ research at Methodist Hospital was in jeopardy. We had created considerable controversy in the clinical and industrial communities.

Passwater: When you asked to do CoQ research at another institution, the administration said, "no."

Judy: Yes, I was told that I couldn't do the CoQ research.

Passwater: And, the reason there?

Judy: I was never given a good scientific reason. I was told that it was not mainstream research, not funded by U.S. drug companies and thus not acceptable.

Passwater: Then you reported several other confirming studies that expanded upon your original research showing that CoQ helped save the lives of many people, and still the medical community suppressed the results.

Judy:
Correct.

Passwater: First, you found your funding cut off, then you found that American medical journals refused to publish your research findings.

Judy:
Yes. Fortunately, European medical journals were not so much influenced by drug companies and I was able to publish my research in European medical journals and in a series of books on the biomedical and clinical aspects of CoQ.

Passwater: But few U.S. cardiologists actually read the European medical journals. It's the "NIH Syndrome," where NIH stands for "Not Invented Here." So, cardiologists did not contact you to learn about your successful protocol with CoQ against heart disease?

Judy: Not from the U.S., at least not from outside the community in which the work was done. Getting my CoQ research published in the U.S. was impossible. I was allowed to present early Methodist Hospital research at American Heart Association meetings and American College of Cardiology meetings, but when we submitted the research for publication, it was rejected.

Cardiologists mostly learn of new drugs from the drug company salespeople who call on them, from U.S. journals and from conferences. Since drug companies did not want cardiologists to know of the heart health benefits of CoQ then, there was little chance that American cardiologists would even hear of CoQ. The molecule was not even discussed in textbooks of biochemistry or pharmacology until the 1990s. Thus, a physician out of medical school before 1996 had little to no chance to learn about CoQ.

Passwater: Did Dr. Folkers or any of his students participate with you in this pioneering heart research?

Judy: Yes, many were supportive and others started clinical studies throughout the world. Dr. Per Langsjoen was the most active in the U.S. We basically ran parallel studies. Dr. Langsjoen, chief of cardiology at Scott-White Clinic (Temple, TX) was very successful in treating people with CoQ and bringing them out of congestive heart failure. This was in the middle to late 1980s, Dr. Langsjoen was so successful that many Texas physicians started pushing the Texas Food and Drug Administration (FDA) to remove CoQ from the health food stores.

Passwater: They were successful by February, 1992 when the Texas FDA physically removed CoQ from health food stores. The natural products industry formed The CoQ Coalition, and Dr. Folkers volunteered to help that group achieve a U.S. FDA safety status called Generally Recognized As Safe (GRAS). I believe that this GRAS petition was never filed, because the 1994 Dietary Supplement Health, Education and Safety Act (DSHEA) was passed. This legislation "grandfathered" nutrients such as CoQ, thereby dispensing with the need for a formal GRAS application.

Judy: In the 1980s, Dr. Folkers provided the FDA with all the toxicity and human safety data that had been collected in Japan and around the world. He and the rest of us worked under an Investigational New Drug license that he was granted by the FDA. Each year all the clinical data from Dr. Folkers' group in the U.S. (Drs. Richardson, Langsjoen, Hall, Elliott, Toth and myself) was collected and sent to the FDA under his license agreement. In fact, in the late 1980s, Dr. Folkers and the University of Texas made an application to the FDA for the approval of CoQ as a new drug for the treatment of congestive heart failure.

Passwater: So the FDA knew what you all were doing and what was going on
because of yearly reports from Dr. Folkers and his application requesting approval for CoQ as a drug to treat heart failure.

Judy: Yes

Passwater: Does that mean that the word about CoQ was getting to a few cardiologists and the public, even if most cardiologists were in the dark?

Judy: Yes, Dr. Langsjoen had treated so many prominent people that the word was getting out. That was both good and bad. It was good that this news could help save the lives of many people, but, unfortunately, this was not happening to any great extent. The word getting out mostly led to further attempts at suppressing the use of CoQ as we just discussed.

It is particularly interesting to recognize that the cardiologists didn't learn of CoQ from medical symposia. They learned of this nutrient's success mostly from their patients who were asking about it. Incidentally, I believe that a major factor in why the Texas FDA let up on its prohibition of CoQ was largely due to public pressure. The editor of the Temple Texas Sun Times, a Pulitzer Prize winner, wrote an article about his own experience as a heart failure patient saved by CoQ. He noted that he had been treated with classical medicines with poor results, but when Dr. Langsjoen added CoQ to the protocol, it brought him out of heart failure The editor reported that he had learned that CoQ saved not only his life but the lives of one patient after another. That stirred up the Texan people, and the Texas FDA soon succumbed to their "harassment." But this action caused Dr. Langsjoen to lose his position at the Scott-\v11ite clinic. He left the clinic and went into practice with his son Peter, who also is a cardiologist. Dr. Langsjoen was a warrior, as was Dr. Folkers. Both also were good teachers, and I learned a lot from them. Dr. Folkers had extensive knowledge of CoQ, and Dr. Langsjoen's special insight revolved around the benefits of CoQ in the failing heart muscle.

Passwater: Today, most people take their dietary supplements for granted. They don't realize that we had to fight the harassment from government agencies, academia and the medical profession. Most people don't realize that vitamin E was banned by the U .S. Postal Service in 1945 and that for years, non-prescription dietary supplements had to be smuggled into this country from Canada. Nor do they recall that CoQ was banned in Texas, and efforts were under way to ban it everywhere in the U .S. This was so ironical because Dr. Folkers, the father of CoQ clinical research, was at that time a noted professor at the University of Texas.

Judy: Yes, although Dr. Folkers was in the state, he couldn't fight them because the University of Texas didn't want to fight the Texas FDA As you mentioned earlier, he did offer to help the industry file for GRAS status for CoQ.

Passwater: It still bothers me that so many of the discoveries about this important nutrient were done here in the U.S., and yet there has been so little official and institutional support for these efforts. Whatever has been learned here about CoQ, it seems, has had to be done by fighting against forces that would have preferred to squelch this work.

Judy: To further complicate matters, Dr. Folkers did not train a single U .S. researcher in his 64 years of research.

Instead, he trained hundreds of postdoctoral students from around the world. So the story that began in the U .S. shifted to Japan in the 1960s and early '7Os because they had a large CoQ supply. The clinical research emphasis came back to the U .S. in the late '70s to the middle '80s when the supply of CoQ was made available to us. Dr. Folkers, through his many students, moved the clinical research emphasis to Europe in the 1980s and '90s. Today, there is ongoing CoQ research in almost all parts of the world. Personally, I do not feel the U .S. is the leader in this research area. Nevertheless, a new generation of investigators has evolved with exciting new approaches to CoQ research. As new as these approaches are, however, they still revolve around age-related, drug-induced, and genetic CoQ deficiencies. Dr. Folkers and the rest of the forefathers of this relatively new molecule in science should be even more encouraged about the promising future .

Passwater: Tell us about what happened. For example, did pressure mount to treat heart patients with CoQ in the U.S?

Judy: For a while. A short time after that the Scott White Clinic yielded to pressure and removed Dr. Langsjoen as chief of cardiology. His success was bringing him too many patients. His colleagues were very unhappy. He stepped down, still ran his practice and then, because of health problems, left the Scott White Clinic and went into practice with his son Peter, a well-known cardiologist and CoQ researcher. Alena Langsjoen. M.S., Peter's wife, is a scientist who also contributes immensely in their research.

Passwater: So, you weren't the only one who had a CoQ research project closed down. In effect, Dr. Per Langsjoen was told he couldn't do any more work with this nutrient.

Judy: Yes, at least not at Scott White Clinic. He and I were not the only ones to face this rejection. There have been multiple instances of scientists and clinicians doing CoQ research both in the United States and around the world and suddenly being told they couldn't continue this work at their respective universities. The pressures are still there, but at least now the clinical attitudes are changing.

Passwater: Was Dr. Langsjoen able to publish his research on CoQ in the United States?

Judy: Yes, finally after several rejections. But it took the help of a couple of reviewers, one of whom actually conducted a multi-center clinical trial on CoQ in patients with ischemic heart disease. This reviewer really went to bat for Dr. Langsjoen's work. Fortunately, he had his champions, and they evidently understood the essential role CoQ plays in mitochondria energy synthesis. His paper was published in the American journal Cardiology in 1992. This was a rare victory, however. Over the years, Dr. Langsjoen submitted many papers on CoQ to U. S. clinical journals, and most were rejected. More recently, there have been four or five papers published in the United States, and one of these, which came out in Annals of Internal Medicine, was a negative paper.

Because we could not get our human clinical findings published in the United States, most of us published our work in Europe or as part of special symposia. I published this part of my work in the European Heart Journal, The Clinical Investigator Journal, and the Journal of Molecular Biology. Almost everyone published outside the United States because CoQ was not a major mainstream pharmaceutical supported by the drug companies. Not being a drug and not being sponsored by a drug firm, it was obviously "no good" in the eyes of the practicing American physician. Meanwhile, many CoQ publications could be found in the United States' biology and chemical journals in the 1960s and '70s. These almost exclusively were animal studies or reports on mechanistic research dealing with how CoQ produces energy in the mitochondria. None of it dealt with improvements in human health. Today there are over 7.000 known publications on CoQ around the world

Passwater: What caused you to leave St. Vincent's Hospital?

Judy:
I left in 1989 to become the director of medical research at a big hospital in Florida. I was to help start a new research center in cardiology. Again, I was told that I could not do CoQ research. Unfortunately-or so it seemed at that time-three days before I was supposed to start, the program was cut because of a proposed state tax on service organizations, including hospitals and research institutes. Thus, the funding was no longer available.

I already had moved my family to Florida, settled in. and I was 5.) years old and without a job. My wife, a nurse, and I decided to make our way on savings. I had a chronic upper respiratory problem every year for 21 years in Indiana and I didn't have it in Florida. We decided we would make our way down here and raise our young family-the children were 10 and 12 years old at the time. So I started teaching at one of the local universities at night as an adjunct professor, and I opened my doors as a consultant. I did some small projects with some medical device companies. I went to work part-time at the Sarasota Memorial Hospital in clinical research conducting studies and writing grant proposals for more research Again I was told that I could not do CoQ research even if I could gain funding in that hospital because CoQ was not recognized by the cardiology establishments nor funded by major drug companies.

In 1995, Dr. Folkers called me. He told me I had been out of the CoQ research loop for too long. He wanted to know what he could do to help me get back in it. I told him I was teaching at a local community college and working part-time in a large hospital, neither of whom would allow me do continue my CoQ research even if I had a grant.

He suggested that I establish an independent research institute. I told him to find the funding required and I would find the facility. He literally put me back to work in clinical CoQ research. He found funding to support the lab and programs. Dr. Folkers. through the Folkers Foundation, helped me get the facility, the equipment, and funded me to continue to work with him in CoQ clinical research. He made contacts for me with Japanese and European companies who were interested in extending the clinical CoQ knowledge base. Dr. Folkers was like a father to me. He got me into the field, supported me for almost 20 years, and told me to fight back when others told me to stop. That was his way. He had hundreds of postdoctoral students from all over the world who have the same attitudes.

This is why we have a significant CoQ knowledge base today. It is growing exponentially. Governments are funding clinical CoQ studies. This now includes the U. S. National Institutes of Health (NIH) . CoQ research will continue around the world, thanks to the efforts of younger investigators who are much better trained than we were, having the same scientific attitude as Dr. Folkers and many others of his generation. Those who are closed-minded and try to suppress and control the direction of scientific progress normally have more to lose than gain.
Unfortunately, economic gains often mean ineffective and costly health care through chemical drugs to millions of taxpaying citizens.

Passwater: Would it be fair to say that Dr. Folkers, the father of CoQ, also is the father of Dr. Bill Judy's research?

Judy: Yes, along with the excellent teachers I had when I still was a student. But Dr. Folkers was the force behind my CoQ work. He semi-retired in 1995 to Lake Sunapee, NH, but continued to work until his death in 1997. Without his efforts and those of all the early CoQ scientist in the United States and around the world, CoQ would not be here today.

His wife had died in 1992, and at age 89, he couldn't adequately take care of himself. He had a vitamin B-12 deficiency, and he was losing the use of his legs and had to use a cane to walk. So he moved closer to his daughter, who was at that time the wife of the president of Princeton University. She could look in on him more often. He was depressed at being retired, so they set him up with a phone and a fax and had people to look in on him to help with his continued CoQ research efforts. I was in contact almost daily as was the group working in Austin, TX.

Passwater: Now that's ironical. A B-12 deficiency! He was responsible for the isolation and synthesis of vitamin B-12. His work led to the cure of pernicious anemia that was killing about 10,000 people a year in the U .S. as we just discussed with Wayne Martin in September. And you're saying that Dr. Folkers had a B-12 deficiency?

Judy: For the man who discovered the B vitamins, this was again another challenge. Throughout his course of treatment. he would push his physicians to use him as a study patient to find out why at his age he was evidently becoming refractory to his B-12 therapy.

Passwater: Did Dr. Folkers want you to continue the heart failure studies?

Judy: No, he said that era had passed. Even before he moved to New Hampshire, he wanted us to start working on CoQ in cancer, as we did with lung cancer at Methodist Hospital in 1983. In that study we prevented the cardiotoxicity of adriamycin in lung cancer patients with CoQ in a randomized, double-blind, placebo-controlled protocol. These patients were kept on CoQ for many years and had minimal cancer reoccurrence compared to the placebo group. We basically had a very positive study in that those getting CoQ could take twice as much chemotherapy without cardiotoxicity and had much less adverse side effects and better tumor suppression than those getting the chemotherapy alone.

Passwater: Did you publish this work in the United States?

Judy: No, when the paper was turned down for presentation at an oncology meeting, we didn't even try. If they wouldn't consider a presentation on the heart failure studies. they weren't going to lift an eyelid to the possibility of CoQ in cancer. We presented the research at an international scientific meeting and got it published in Europe.

This was the initial study that indicated to me that CoQ may be beneficial in preventing the adverse side effects of cancer therapy in man. But Dr. Folkers saw more than this. He was involved in research with others in the 1970s about a role for CoQ in the immune system. Dr. Emile Bliznakov and others in 1973 had shown a potential role of CoQ in cancer therapy in the mouse with the Friends Leukemia Virus. Dr. Bliznakov proposed that CoQ should be considered as an integral part of the host defense system through its stimulation of the immune system years before its potential role as an antioxidant was recognized.

Passwater: Why did Dr. Folkers want you to continue the CoQ-cancer research?

Judy: He obviously knew more than I did. He was aware of the work in this area in animal models and with CoQ in the immune system. I thought the benefits were in preventing the adverse side effects of chemo- and radiation-therapies, and possibly via the enhancement of the immune system. Dr. Folkers evidently had been active for years in this area. He was aware of the cancer regression in the congestive heart failure patients who had been given CoQ for a long time in the studies conducted by Dr. Langsjoen and myself, the breast cancer studies in Denmark by Dr. K Lockwood and colleagues, his own personal experience with cancers in friends to whom he provided CoQ, the fact that my group had prevented the adverse side effects of chemotherapy and radiation therapy with CoQ, and he was conducting studies in the United States and Europe that showed blood CoQ deficiencies in hundreds of patients with various types of cancer with and without therapies.

Passwater: Has any of this work been published in the States?

Judy: Yes, in the biochemistry and biochemical journals, but not in the clinical oncology journals where it needs to go if it is to be read by cancer researchers and clinical oncologists.

Passwater: Dr. Judy, let's break at this point and pick it up again next month. Our readers will especially want to learn about your exciting results with CoQ against prostate cancer. WF

2002 Whole Foods Magazine and Richard A. Passwater, Ph.D.
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