Dear Friends and Patients:
In the March 2012 Newsletter I completed the “Top 5 Foods to Avoid” series and also began a series on oxidation and reduction reactions, and aging. I discussed the importance of methylation and glutathione for health, detoxification, and slowing down the aging process. In this issue of our Newsletter I will be sharing how the active forms of vitamin B12 and folate fit in with methylation reactions and glutathione, and why active forms of these vitamins are necessary. But first let’s turn our attention to the new FDA (Food and Drug Administration) warnings on statin drugs that came out in February 2012.
I first read about Dr. Duane Graveline, a former NASA astronaut and flight surgeon, in a 2008 Discover magazine. I’d like to share that story with you. In 1999 he was found to have an elevated cholesterol on a lab test. He had no heart disease, and like many Americans, his physician prescribed Lipitor to lower his cholesterol level. In just 6 weeks after he began taking this drug, his active and healthy life came crashing down. He lost his memory. His wife rushed him to the hospital, where doctors could find no medical or psychiatric problem, and his brain scan showed no sign of stroke or brain disorder. Just as quickly as his memory disappeared, it came back. Doctors termed the strange episode transient global amnesia or TGA. The cause – unknown.
Dr. Graveline wondered if the memory loss was related to the new statin drug he was taking and for the next year he decided to leave it in the bottle. When his annual astronaut’s physical came around, he was told that his cholesterol had crept up again and his doctor urged him to go back on Lipitor. He did, and within 10 weeks he suffered an even more severe episode of amnesia. His wife found him wandering around, outside their home, unaware he was a physician and unaware of who she was. That episode also resolved without treatment other than stopping the Lipitor he was on. Dr.Graveline decided never to take statins again. Although Graveline’s case was certainly unusual, what if he had an episode while he was driving his car? Or if a pilot developed TGA during a flight?
The FDA said that statins may increase users’ risk of brain-related effects like memory loss and confusion. The reports have generally not been serious, however, and the symptoms go away once the drug is stopped, the agency said. Statins’ labels will now also warn patients and doctors that the drugs may cause a small increase in blood sugar levels and risk of Type 2 diabetes — an effect that has been shown previously in studies. Type 2 diabetes can further increase the risk of heart disease.
In addition, the FDA made a label change specific to Mevacor (lovastatin). Mevacor can interact with other drugs, increasing the risk for muscle pain and weakness, another side effect that has previously been associated with high-dose statin use. Other drugs may raise such risks by increasing the amount of statins in the blood, and the FDA warned that Mevacor should not be taken with protease inhibitors, which are used to treat HIV, certain antibiotics and some anti-fungal medications.
In the 1970s, when I was a medical student and resident physician, a normal cholesterol was 240mg/mL or below. This changed in 1993 where the new guidelines were revised downward to 200mg/mL by a committee of nine doctors, eight of whom were receiving money from statin drug companies. Even a 2006 article in the Annals of Internal Medicine argued that there was no evidence to support this target or the mainstream medical belief that lower cholesterol levels are always better.
John Abramson, M.D. is a Harvard trained physician and author of the book Overdosed America. He has spent many years in clinical practice as well as years in researching the whole cholesterol story. His research has shown that there is not a single randomized control trial that shows cholesterol-lowering statin drugs are beneficial for women of any age or men over 65 who do not already have heart disease or diabetes. Diet and exercise are far more important risk factors in the development of heart disease. Statin drugs are not a substitute.
What if the potential benefits of statins may not outweight their risks. The only way to weigh risks vs. benefits is to evaluate all-cause morbidity (sickness) and all-cause mortality (death). However, statin drug studies were not designed to look at all-cause mortality. They were designed to look at cholesterol levels, heart attacks or death from coronary causes.
Getting back to Dr. Abramson’s research, he found the statin data showed only in a small fraction of the people taking the drugs could statins reduce heart attacks and strokes. Doctors give statins in one of two ways. The first way is to give the drugs to people with elevated cholesterol as primary prevention – to prevent a heart attack, stroke or other serious cardiovascular event. These are people who have never suffered an event. Over 75% of statin prescriptions are written for this reason. As I stated earlier, Dr. Abramson found that there were no studies that showed statins were beneficial for primary prevention for women of any age or men over age 65. The other way to give statins is as secondary prevention, after people have had a heart attack or stroke, or develop diabetes. Dr. Abramson found that even when statins are used for men at the highest risk, “you have to treat about 238 men for one year to prevent one heart attack. . .” These findings were published by Dr. Abramson in the prestigious British medical journal The Lancet. Another way of stating this conclusion is if you are a man and are at very high risk for developing heart disease, there are 237 out of 238 chances taking a statin won’t benefit you.
One of the reasons doctors overlook risks and believe statins to be safe is that most controlled studies of statins wind up excluding people who originally began to participate in a study but stopped taking the drug due to side effects. These test participants are then dropped from the study as “non-complaint.” By excluding these group test participants, the evidence is then wrongly interpreted as absence of harm.
Abramson and others have reviewed the medical research data on statin drugs and have determined they should not be used in women of any age and are of limited benefit in men under the age of 65 who are at high risk for heart disease but do not yet have it.
And How Vitamin B12 and Folate Fit In
Methyl B12 is constantly recycled by the body. It donates its methyl group to homocysteine, which then turns into another amino acid, methionine. Once B12 is missing its methyl group, it needs to get a fresh one, and that’s where methylfolate comes in. When your level of methyl B12 is low, homocysteine builds up and this can cause heart disease and hardening of the arteries. Elevated homocysteine levels are also found in Alzheimer’s disease. Homocysteine levels are measured by a simple lab test.
Inflammation of the nerves is a complication of diabetes called diabetic neuropathy. It is a very painful condition. In a 2011 study reported in the Review of Neurological Diseases, patients with diabetic neuropathy were given a mixture of methyl B12, methylfolate, and the active form of vitamin B6 (pyridoxal-5’-phosphate). Tissue biopsies were taken before and after treatment with these vitamins. 73% of diabetic patients showed improvement on their biopsies and 82% reported reduced frequency and intensity of pain and numbness using this vitamin therapy.
Another study reported that patients with major depression responded to methylfolate in combination with antidepressants. In this 2011 study only 16.3% of patients responded to antidepressants alone while 40% with the combined therapy experienced major improvements. In a 2009 study at Harvard Medical School, methylfolate by itself helped in reducing depression both in patients with low and normal folate levels. It also helped in elderly patients with dementia. This may be because folate is a necessary co-factor in the production of three neurotransmitters — serotonin, dopamine and epinephrine. Methyl B12 and methylfolate may help some children with autism. In a 2009 research study of 40 autistic children treated with methylcobalamine and folinic acid, there were significant increases in cysteine and glutathione after three months. Low levels of folate are also associated with anemia, heart disease, fetal abnormalities such as spina bifida, neuropathies and ADHD.
[Again, I would like to give credit to articles published in the October 2011 Focus Newsletter of Allergy Research Group for some of the data presented in this section.]
At times we see patients come in taking multiple supplements. If a person is healthy, the excess supplements are removed by the liver and kidneys. Sometimes too much of a good thing can cause symptoms. I suggested Mr. H. continue on the bone health supplements that I had prescribed, but to reduce his many other supplements to a multivitamin/multimineral and omega-3 oil supplement only.
Another patient recently treated with IV Glutathione and B vitamins was Ms. M. She is a 60 year old lady who has multiple medical problems, including hypertension and D.M. Type II. Ms. M had been under a great deal of stress for about a year, having gone through a divorce, but the preceding 3 months were especially bad for her. She recently had a bout of food poisoning and just felt “off.” She found herself awakening at 1:30 – 2:00AM most nights. In the Chinese acupuncture system this early morning time corresponds to the liver meridian. I suspected she was having a detoxification reaction. Ms. M received an IV with Glutathione and B vitamins, and in the middle of the IV felt dramatically better with no further malaise and improved mood. She was scheduled to see me the following week but elected to receive one more treatment prior to her office visit.