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Thursday, October 28, 2010

red yeast rice and cholesterol

I've been meaning to post about red yeast rice for some time. Red yeast rice, is produced by cultivating the yeast strain Monascus purpureus, either spores or a prior fermented rice, on rice. Each rice grain turns bright red in its core and reddish purple on the outside.

The fully cultured rice is then either sold as the dried grain, or cooked and pasteurized to be sold as a wet paste, or dried and pulverized to be sold as a fine powder. China is the world's largest producer of red yeast rice.

Many red yeast rice products contain monacolin K, a compound identical to the drug marketed in the U.S. as lovastatin. Red yeast rice products that contain monacolin K, are banned in the by the Food and Drug Administration in the United States, which has stated that such products are identical to a drug and thus subject to regulation as a drug. In 1998, the FDA initiated action to ban a product (Cholestin) containing red yeast rice extract. The U.S. district court in Utah allowed the product to be sold without restriction. This decision was reversed on appeal to the U.S. District Court. Shortly thereafter the FDA sent warning letters to companies selling red yeast rice,and the product disappeared from the market for a few years.

In 2003 red yeast rice products began to reappear in the U.S. market (see the Wikipedia discussion referenced above) and avoid FDA requirements by making no claims about cholesterol lowering. Some contain no monacolin K. Two reviews referenced on the Wikipedia site indicate that monacolin content of red yeast rice varies widely. The FDA also issued a warning press indicating that consumers should “…not buy or eat red yeast rice products…[which] may contain an unauthorized drug that could be harmful to health.” The rationale for “…harmful to health…” was that consumers might not understand that red yeast rice might have the same side effects as prescription statin drugs.

In my view, this is absurd and is like saying that because tomatoes have potassium we are now banning tomatoes since potassium is marketed by itself as a drug and can be harmful to people with kidney failure who might not realize that they contain potassium. All Americans should be up in arms at these FDA rules. There seems to be no other reason for this than the financial well-being of the pharmaceutical companies selling statins. No pre-existing foodstuff, extract, or supplement, should be banned simply because a drug company decides to isolate and sell a compound in it for profit. If it requires regulation, then regulate it, and if it is identical to a drug, then it should be lawful just like that drug. If it does not require regulation (which I believe), then perhaps its drug cousins should be made over the counter too. Many of our OTC drugs have dangers which consumers need to know about, but regulating them through prescription is ineffective and just makes them expensive.

I welcome my reader's views on this topic!

Stick with the best thing, not the next best thing

I keep seeing advertising touting the efficacy of fruit and vegetable extracts such as Juice Plus, promoted by some local practices which call themselves "Integrative Medicine" practices. Juice Plus and similar products purport to lower your cardiovascular and cancer risk and to have research to back them up. The Juice Plus website contains links saying "feel free to look at the research" I decided to do so for my readers to see if there is research supporting its efficacy.

The research I found was all based on what I would call "surrogate markers". That is, no studies demonstrate that anyone actually lives longer through using Juice Plus. All the studies focus on clinical endpoints like flow through certain vessels, or inflammatory medidators in the blood. Most of the trials, also, were not randomized controlled trials, that is, there was no control group in the study, which compared subjects to themselves at "baseline". The problem with this approach is that other changes occur when people are enrolled in studies which may have nothing to do with what is being studied.

So, while these results do not suggest that Juice Plus does any harm, they are certainly not conclusive about its benefits.

The studies do not compare Juice Plus to a diet containing lots of whole fruits and vegetables. This would be the most relevant comparison, and I remain an advocate of eating the whole fruits and vegetables instead in absence of evidence otherwise. Cheaper and more flavorful, too.

I would like to be cautious as I may have missed some literature, so if anyone including the makers of Juice Plus knows of evidence of which I am unaware, please comment on this post!

new brain death guidelines

The new guidelines for brain death in the journal Neurology this year state that they are attempting to make a very variable process for determining brain death more uniform. I am concerned about two things in the guidelines.

The first problem is accepting only one examination to determine brain death. All human evaluation is subject to error and a brain death exam is no exception. The reliability and consistency of all physical examination and diagnostic tests is not 100% and in some cases is extremely low. When declaring brain death, a judgment based on many, many tests and findings, the possibility of error increases, and requiring two examinations would make the probability of error a little lower, although not zero. Allowing brain death to be declared with only one exam greatly increases the false positive rate. I cannot agree with this strategy, inconvenient and costly as it may be for our medical system to keep someone alive who has only a slim chance of recovery.

Many of my readers may not agree, but I personally abhor the recent trend in Medicine towards allowing people to die, even when they and their families wish such efforts to be made. While I will defend to the death (now increasingly easily labelled!), that we should follow patients' wishes, those who wish to "rage, rage against the dying of the light", as Dylan Thomas urged, should be supported to do so. It is a very important moral and ethical use of our health care funds, as this care for life is an important piece of our humanity.

I have always valued the lesson taught me by one of my patients when I was a medical resident in training. She was a radiologist in her 30s who developed very severe systemic lupus erythematosis. She had hemolytic anemia (a process where her immune system destroyed her own blood cells), gangrene, and many infections of a catheter inserted for temporary dialysis. She needed constant transfusions, and her blood was infected. She had pneumonia and kidney failure. Her blood pressure was low. She kept us day and night for weeks treating her illness. We became tired and fatigued. I felt we were fighting a hopeless battle and that we should let her die. Her husband wanted us to do everything to try to save her. Her attending physician insisted that we keep at it. We did. She recovered completely. 25 years later, she is still alive. Recently on an East Coast trip, I took a detour and visited her at her home a few years ago and thanked her for what she taught me: A patient's life should not be threatened by doctors' fatigue and their feeling that dedicated family members are over the top. These family members may need to be over the top to save the lives of their dear ones. Young doctors do not appreciate the potential for recovery and the meaning of death. How can they when they so often have had so little experience of life?

Our protocols for brain death should err on the conservative side, because the doctors in charge, de facto, of these decisions in our acute care hospitals are so young and so often err the other way. What's your opinion?

Why hire a health care advocate

Here's a good article by Dr. Carolyn Clancy of Agency for Healthcare Research and Quality (AHRQ) about why you may want to have a health care advocate with you in the hospital or doctor's office.

I am proud to provide health advocacy services, among others, to my patients. If you are over 18 and live in California, and may be interested becoming part of my practice, please see www.myadvicedr.com for information about how to obtain a free consultation to see if I may be able to help you.

So how homey is a medical home?

The new health care legislation is looking to primary care doctors to create "medical homes", defined as primary care practices that provide 24/7 access to their doctors, electronic medical records with exchange of information with other providers, a patient-centered holistic approach, and coordination of care by other specialists.

A study published today funded by the Commonwealth Fund, carried out by the American Academy of Family Practice, shows that to achieve this, doctors need a lot of help, and that even with this help, they may actually not improve things, as evidenced by patients being less satisfied than before. The national demonstration project published today showed that 36 family practices made small improvements in clinical quality measures, summarized as "better preventive care and access". Access meant ability to get in for an appointment or reach someone to talk to...not related to patient's views of their access or whether they were able to go to the best specialist, surgeon, and the best hospital they could have for specific medical conditions requiring intervention). Patients with high blood pressure and diabetes had slightly better control of their blood pressure and hemoglobin A1C (a measure of blood sugar control for patients with diabetes) levels. However, patients actually rated their care worse after the practices made changes. Patients' ratings of access to care, care coordination, comprehensive care, and service relationship were worse after implementing more of the features of the "medical home". I guess the medical home can be not too homey.

In contrast, Group Health Cooperative of Puget Sound, a large health care system, mounted a successful demonstration project of the "medical home", showing it boosted quality and patient satisfaction and saved money by helping its practices become "medical homes".

The message is that big organizations will be much better able to achieve the "medical home" features in a way that does not impair service to patients. Large organizations may also already have had lower levels of patient satisfaction, so they did not fall by becoming "medical homes", which generally rely on ancillary practitioners for more things and may reduce access to doctors. For smaller practice, electronic medical records, registries and greater use of ancillary support do not necessarily mean that things will get any homier for the patient. On the contrary.

Unfortunately, big organizations may also provide perverse incentives to helping patients choose the best specialty and surgical care. We've seen this with the Medicare Advantage plans. When primary care doctors have incentives to choose doctors and specialists and hospitals in the same health care delivery system, or coverage requires them to, patients lose out, because it will limit the specialty and surgical providers and hospitals to whom primary care doctors refer their patients. Often there are financial incentives within the same system to choose providers there, and this will be even worse when payment moves to an "episode of care" approach, meaning that patients will have to go to the same system of care for an entire "episode", even if there were better providers around for specific pieces of that episode. So, for example, you will no longer be able to receive your follow up care from surgery in a different system than the surgery itself, since the payment is likely to be bundled.

Many patients would prefer to go to smaller practices for their primary care, with a more personal feel where they still feel like human beings, and prefer to be able to choose the best specialty surgical provider and hospital for their particular problem. Unfortunately, the direction in which our health care system is moving will make this model more difficult. If episode-of-care bundled payment happens, small primary care practices unaffiliated with surgeons, specialists and hospitals will be forced out of business.

The authors of the summary article reached that same conclusion and recommended that third-party payers turn to arrangements such as monthly capitation payments to make medical homes worthwhile for physicians. "Expecting practices to front the cost of transformation with the hope of more appropriate reimbursement in the future is unlikely to succeed," they write.

Friday, October 15, 2010

Get Tested for the KRAS Gene

Yale Researchers, in August 2010 Cancer Research, reported discovering a new genetic marker for ovarian cancer which is present in 61% of women with a family history of breast or ovarian cancer who were not positive for BRCA-1 or 2, the only known genetic markers until now. It was also present in these women's family members with cancer. The marker was present in 25% of all women with ovarian cancer, and was linked to an increased risk of developing ovarian cancer after menopause, as confirmed by two independent case-control analyses. The research findings strongly support the hypothesis that the KRAS-variant is a genetic marker for increased risk of developing ovarian cancer and suggest that the KRAS-variant may be a new genetic marker of cancer risk for HBOC families without other known genetic abnormalities. Why is this important? Because ovarian cancer usually doesn't get detected until it's too late. If you have a family history of breast or ovarian cancer, and you are negative for BRCA-1 or BRCA-2, testing positive for this marker means you should probably get screened more carefully for ovarian cancer. So, look for genetic testing soon for this marker.

Thursday, October 14, 2010

Walk a few miles a week to maintain your brain volume

Published online prior to publication by Pittsburgh investigator Erikson in the journal Neurology yesterday is a study reporting the link between physical activity and brain volume and function in the elderly. The 299 participants examined, averaging age 78 at the time the study began, were part of a study of cardiovascular health. The investigators looked at the relationship between physical activity, brain volume, and cognitive function. They split participants into 4 groups according to how much they walked during an average week (the range was 0-300 blocks per week). Brain scans were done 9 years later and cognitive function tests were done 13 years later. Yes, folks, you read that right, 9 and 13 years. These authors certainly cannot be accused of short follow up periods. Those who had been doing more walking maintained greater brain volume, associated with better cognitive function than those who did not walk a lot. Increasing amounts of walking up until 72 blocks per week were associated with improvements in brain volume and cognitive function. Greater amounts of walking than 72 blocks did not result in further increases in brain volume. So, keep trotting, trekkers!

Smoking marijuana helps neuropathic pain

A study from Canada by lead investigator Mark Ware and colleagues from McGill University Health Center in Montreal, published last month, reported that patients who have "neuropathy", or pain from injury to nerves, were helped by smoking marijuana. One can empathize with, and congratulate, this study team because due to our prejudices about marijuana, this was not an easy study to get approved.

Because neuropathic pain (for example that caused by chemotherapy for cancer) is so challenging to treat, it is great to have anything more to offer patients in the repertoire of effective treatments. The patients in the study were given marijuana to inhale in a single puff of 25 mg at one of 4 concentrations (0, 2.5%, 6% 9.4%) of tetrahydrocannabinol herbal cannabis 3 times a day for 5 days. The trial was done as a randomized controlled crossover trial of four 14 day periods of time(meaning that each of the 4 groups got a different dose of marijuana during each of the time periods) Only the 9.4% dose achieved pain relief compared to placebo. Those taking this dose also slept better and reported better quality of life.

Because of the dangers of smoking anything (and cough was one of the side effects seen), it may be better for one's health to have marijuana applied using an alternate delivery system such as a patch, and I hope this will be investigated. Pills or other oral vehicles have generally been considered too psychoactive and hallucinogenic to be usable medicinally.

The study examined a very wide range of adverse effects. Interestingly, apparently due to the fairy low dose of even the highest dose group, only one participant in the entire trial reported feeling euphoric or high.

Also reported last month were the positive effects of marijuana in early schizophrenia, which I will write about in a separate blog, so it was a big month for those who support and promote medical marijuana.

Sunday, October 10, 2010

Sleep enough if you want to lose fat when you lose weight

An article in this week's Annals of Internal Medicine studied physiologic responses in 10 dieting adults, 5 of whom slept 5 1/2 hours per night and 5 who slept 8 hours a night. The article showed that the 5 who slept less lost 55% less fat than the ones assigned to sleep more despite taking in the same number of calories and losing similar total amounts of weight. Instead they lost more non-fat body mass pounds to make up the difference.

This study included only 10 people, and excluded people who drank a lot of caffeine. Therefore, it is unclear how generalizable the study is.

This study has been extensively misreported as showing that lack of sleep leads to less weight loss while dieting rather than the percent body fat lost. Nonetheless, it suggests that if you are dieting, you may wish to make sure you get enough sleep so that you lose fat instead of non-fat mass. The study should be repeated in a larger sample.