I am pleased to say that Dr Berkson agreed to answer a few questions for Anticancer.org.uk, the first part of which appears below.
PP: Background - how did the LDN/ALA protocol arise?
BB: Alpha Lipoic Acid (ALA)
While working as an internal medical resident at one of the Case Western Reserve teaching hospitals in 1977, I was told by the chief to follow two patients with severe and acute liver damage that resulted from eating hepatotoxic mushrooms. This condition is often fatal and I was told that these patients would surely die.
As a medical doctor it was necessary to follow the orders of the chief; however, as a PhD, I sought new ways of doing things. I called Dr. Fred Bartter (former chief of endocrinology) at the National Institutes of Health and asked him if he knew of anything that would help regenerate damaged organs. He answered that he was working with thioctic acid (alpha lipoic acid, ALA) as a possible treatment for diabetic complications and when given to people with diabetes, it seemed to help heal damaged livers and other organs.
Dr. Bartter sent me a case of ALA for intravenous administration. I picked it up at the Cleveland airport about seven hours after I initially called him. I rushed back to the hospital and injected the ALA into the two patients. I administered this treatment every six hours for 14 days. The patients started to recover and felt much better by the second day and were able to leave the hospital within two weeks with normal liver function. They are still alive and free of liver disease today, 34 years later.
It is interesting to note that some of the chiefs at the hospitals where I practiced medicine seemed to discourage my use of ALA. I was told that with an M.D., and a Ph.D. in cell biology/microbiology, and internal medicine training, I should concern myself with doing infectious disease research and stay out of liver disease.
Dr. Bartter, however, thought our work was very important and told me that some day we might win a Nobel Prize for our human work with ALA. He suggested that I leave Cleveland and come to work with him at NIH. But I was very discouraged by the response that I experienced from the medical community in Ohio. I left the region and moved my family to a rural community not too far from Lubbock, TX.
I became a country doctor, driving from one hospital to another each day, and even delivered babies in people’s houses on isolated ranches. When my children were high school age we moved back to a relatively large city. About fifteen years ago, I opened an integrative medical practice in Las Cruces where I use antioxidants and certain innovative prescription drugs to treat diabetes, chronic hepatitis, rheumatoid disease, lupus and other disorders with exceptionally good results. I also try to support and improve the immune system of people with cancer.
Low Dose Naltrexone (LDN)
One day, a man came into my office with a walker. He was in terrible pain and could hardly even move. He was about 70 years old. I asked him what was wrong, and he told me that he had just been to MD Anderson Cancer Hospital, and they told him he had metastatic prostate cancer -- metastatic to his bones. He also had lupus and rheumatoid arthritis. They told him he only had several weeks to live. Nothing could be done. So I asked him, “Why are you in MY office?” He said he had a wife with dementia and a son with a mental disability, and he had to have them placed in a nursing home before he died. I asked what I could do for him. He said he really needed some narcotics to handle the pain. I said I’d be glad to write that prescription for him. Then he asked me if I had ever heard of Dr. Bihari in New York. This was 15 years ago. I said no, I never heard of him. He told me that he had heard that Dr. Bernard Bihari was curing cancer. I said, “I don’t know why you're in my office, or MD Anderson or the Mayo Clinic. I don’t see any great results for curing cancer from any of these places. In addition, I told him that I don’t know how to cure cancer. They treat cancer at MD Anderson and at the Mayo Clinic, but I haven't seen any great results with complicated cancers. So why don’t you go up and see him?”
So he said, “Well, he’s just in a little office in New York. What does he know?” And I told him the story of when I was at a university hospital with alpha lipoic acid, which was really effective at regenerating livers and many other organs, too, and they just didn’t want to hear about it. They were in the liver transplant business. So I said, “Maybe if he was at a big medical center like Sloan Kettering or MD Anderson, and he discovered a simple cure for cancer, they'd probably throw him out, because it would put them out of business.” So he went up and saw Dr. Bihari. And I didn’t see him for 3 years.
Three years later, he walked in, without his walker, a normal guy. I said, “John, how are you doing?” And he said, “You know, I have a sinus infection. I really need something for these allergies.” I said, “No, John, what about the cancer?” “Oh, Dr. Bihari cured that” – in a very relaxed way. I said, “What about the lupus and rheumatoid arthritis?” “Oh, he cured that, too.” I asked, “What did he use?” He said, “Did you ever hear of naltrexone?” I said, “Sure, it’s something that doctors administer to heroin addicts, because it occupies their opiate receptors. When they shoot up, they don’t feel the heroin.” He said, “Well, Dr. Bihari found that if you take a tiny amount of naltrexone, a very low dose, and you take it at bedtime, it sort of tweaks the opiate receptors in the brain and on the immune cells and by morning, it modulates the immune system to reverse autoimmune disease and it seems to stop many cases of terminal cancer from growing.”
I was very skeptical. But my wife had two aunts who had lupus and rheumatoid arthritis. They were actually on chemotherapy drugs, like methotrexate, and steroids like prednisone, that swelled them up. And the methotrexate was killing their bone marrow, affecting their heart. And they weren’t getting any better. So, I asked them if they wanted to try this low dose naltrexone. They said, “Sure.” In one month, they were completely normal, off all drugs, and just taking this $15 a month prescription.
Then I had about 100 patients who were rheumatology patients with lupus, rheumatoid arthritis and dermatomyositis. I would say that within one month, 95% of them are off all medications and feeling normal.
Now, I've also had some wonderful successes treating cancers, including pancreatic cancers, with a combination of these two drugs. One of my patients came to me after being told by MD Anderson that he would die within a few months. He had nothing to lose and was eager to try alpha lipoic acid and low dose naltrexone in combination. Within 3 months, he was able to go back to work; he has been alive for eight years. It is quite incredible, because pancreatic cancer is one of the cancers that are considered a death sentence by all oncologists. They're pretty much in agreement on that. I’ve published my results – a case study -- in 2006 in Integrative Cancer Therapies. I recently published two more papers describing successes with four more patients using the ALA/N protocol; one B-cell lymphoma and three more pancreatic cancer patients.
After the successes with both ALA and LDN, I decided to combine the therapies. I've had some amazing results and some failures.
PP: Have you had additional positive results since publication of your two papers on the protocol? Are more papers/case reports in the pipeline?
BB: We have had many more positive results with the ALA/LDN protocol.
At present, my son Arthur Berkson MD and I are preparing a paper for publication on about 70 systematic lupus erythematosus (SLE) patients who were on very expensive and potentially dangerous drugs. After about a month, most were off their regular drugs and just on the ALA/LDN protocol and a healthy life style program. As long as they stayed on my program, they felt normal without any symptoms of SLE. We are getting the same great results with rheumatoid arthritis and dermatomyositis.
In addition, we are preparing papers on successes with carcinoma of the lung, hepatocellular carcinoma, and some breast cancers.
PP: What has been the response from mainstream oncologists, including the NIH?
BB: There is absolutely no interest from mainstream oncologists or rheumatologists in the United States. The few oncologists that I know personally refuse to even listen to any discussion on the protocols and they seem to get angry if I bring up the subject. There has been, however, some interest in Europe and Asia.
It is interesting that Dr. Bernard Bihari, a few years ago, told me that when he studied drugs that were money makers for major pharmaceutical companies, he had no trouble publishing the results in mainstream journals. However, when he tried to publish his results on LDN, no journal was interested.
In addition, one of my colleagues adds my published peer-reviewed papers on ALA, LDN, cancer, etc. on Wikipedia several times a month. The next day all references are erased. The information is almost completely ignored or banned in the United States.
There has been some interest, however, from the National Cancer Institute. I was invited to present a discussion there in 2007. They summarized my presentation as;
NCI Conference: Low Dose Opioid Blockers, Endorphins and Metenkephalins
“Promising Compounds for Unmet Medical Needs”
Personal experience with LDN for various cancers – Burton Berkson, M.D., Ph.D. Dr. Berkson shared his experiences of LDN by demonstrating four interesting cases. The cases showed that LDN is well tolerated and to date, some of the patients suffering from pancreatic cancer, B-Cell Non-Hodgkins Lymphoma are alive and well. All of the mentioned patients received low dose naltrexone at 4.5mg Qhs [every bed time – Pan], in addition to incorporating a healthy lifestyle, diet, supplemented with alpha-lipoic acid and vitamins. The patients reported an improved quality of life and stable disease ranging up to 55 months on naltrexone therapy. PET Scans showed notable improvements for several patients. In some cases where CT showed no major change in tumor size, the PET scan did show a change in uptake after naltrexone was administered which did correlate with clinical improvement. There was not a significant change in the sizes of the tumors, but LDN played a major role in stopping the activity of the disease.
I have been invited back to the NCI to present more information in March 2012. So, maybe eventually there will be some interest in these protocols in the U.S.
PP: And the response from clinicians outside of the mainstream?
BB: Outside of the mainstream, there has been great interest from integrative doctors in my protocols. Next month I'll be presenting a workshop on IV lipoic acid at the American College for the Advancement of Medicine conference in Portland, Oregon. And in December, I am honored to be invited to receive the lifetime achievement award from the Arizona Homeopathic and Integrative Medical Doctors in Scottsdale Arizona.
PP: What are the prospects of a formal clinical trial?
BB: A formal trial costs a lot of money. So, when a corporation invests in such a trial they expect, rightfully, to earn a return on their investment. Lipoic acid is a naturally occurring substance and cannot be exclusively patented. So, if a company spends hundreds of thousands or millions of dollars on the trial and develops a product, they will not have exclusivity, and another company will undersell them. So, they will lose a lot of money.
Maybe a foundation or NIH will support such a trial in the future.
PP: Do you have a feel for the proportion of patients that show a response to the treatment?
BB: For rheumatoid arthritis, systemic lupus, dermatomyositis, etc. the response rate is more than 80%. Most patients are off all of their drugs within 3 months.
For cancer, the response rates are variable. It depends on many factors. What type of cancer does the patient have? How far along are the cancer metastases? How much standard chemotherapy and radiation has the patient received? What is the patient's mindset? Does he believe his oncologist that there is no hope?
We have many patients on our therapies and many of the cancer patients continue to live for a fairly long period of time. Some are free of the cancer and its metastases on their PET scans within 6 months. One man with a "terminal" stage 4 pancreatic was alive and well 8 years after he was told to go to hospice. Another is alive and well 6 years following this same diagnosis. Another man with small carcinoma of the lung is alive and well 6 years following a hopeless diagnosis. And there are several more. And there are failures too.