Offit's lead editorial in the May issue of JAMA - profound

Paul Offit’s editorial in The Journal of the American Medical Association (JAMA. 2012;307(17):1803-1804.)  goes through the history of the National Center for Complementary and Alternative Medicine(NCCAM) and nicely points out that studies funded by NCCAM have failed to prove that complementary or alternative therapies have any more benefit than placebos.

Offit points out how NCCAM spent $374,000 proving lemon and lavender scents do not promote wound healing, $750,000 to prove that prayer does not cure AIDS, or improve recovery from breast reconstruction; $390,000 to find that ancient Indian remedies do not control type 2 diabetes, $700,000 to find that magnets to not treat arthritis or even carpal tunnel syndrome; and $406,000 to show that coffee enemas do not cure pancreatic cancer.

As much as we would love to find the new treatment that is available in your grocery store, or Ace Hardware, or Starbucks – it just has not been found.

Still, proponents of acupuncture, homeopathy, naturopathy, and even HCG diets, insist they have proof it is always in their own journals, with less than rigorous studies, and never reproduced in major medical journals. But clearly, science is less important to those who take these “treatments” than the potential of placebo effect.

This Month's art is called "Circus Side show" Appropriate for NCCAM

Offit points out that while many drugs today were originally derived from plants (aspirin, quinine, digitalis, and artemisinin ) – the funding from NCCAM is not about finding the next great herb, isolating the ingredient, and then working out the chemistry. Instead NCCAM seems to be spending money on studies that reasonable people would laugh at, and know that they will lead to no improvement in the health and well being of our citizens.

Projects that funded programs are recruiting for include:
So I went to NCCAM website to see what sorts of programs they are funding and would they be, on the simple sniff test, something that would make sense in an era when we have a limited number of research dollars. Here is what I found:

A Pilot Study of Acupuncture Treatment for Dysphagia:
No study to date has found a use for acupuncture, why they keep looking is beyond me.

Antioxidant Therapy to Reduce Inflammation in Sickle Cell Disease:
Science is clear that most antioxidants are inactive when they leave the stomach, basic chemistry 101, and antioxidants have never been proven beneficial in any disease yet so why we continue to put money into this is proof that Snake Oil Salesmen abound.

Hypnosis for Hot Flashes Among Postmenopausal Women in a Randomized Clinical Trial:
How you randomize for this, do you have non-hypnotized women?
Patient Response to Spinal Manipulation – Pilot Study:
Spinal manipulation again, while massage has proven worth, spinal manipulation never has and it is an embarrassment that we allow chiropractors to be anything more than a historical footnote.
Probiotic Lactobacillus GG (LGG) in Patients with Minimal Hepatic Encephalopathy:
So you get a bunch of bad liver patients together, give them a dose of bacteria that won’t reach the colon and think you have a study. Amazing how probiotics have caught the attention of the public and marketers when we know  they are essentially useless unless done through a fecal transplant via colonoscopy.

Quantification of Outcome Measures for Mind-body Interventions:
How do you quantify the mind? What is mind over matter – and how come it doesn’t work when you have a real issue like an automobile accident or traumatic stab wound to the heart

Sauna Detoxification Study: Pilot Feasibility:
Ok, my ancestors from Norway love Saunas, but they detoxify nothing. Sweat glands in saunas cool people by simple sweat that is sodium chloride- there have never proven to be toxins in any sweat, in spite of what “ancient Chinese medicine” might think

We need regulation for supplements and Alternative Medicines

Better yet, if NCCAM would develop a registry where various herbal supplements that are sold would be noted, and tested to see if there is actually the ingredients that they state are. Then serve as a registry for adverse events, something the FDA is prohibited from doing. Because of the Dietary Supplement Health and Education Act of 1994 the FDA has no role in regulation of these items. But having a registry where reports of adverse events could be noted would be helpful. Manufacturers are not required to submit safety information before marketing “dietary supplements,” so only after multiple adverse events can the FDA act. Since the FDA is prohibited from monitoring and regulating Alternative medicine products, the public is virtually unprotected against supplements and herbs that are unsafe.

The article goes on to show that clear evidence that there is no efficacy or therapeutic value to these supplements does not stop people from buying them. This is further need that those individuals will consume anything with a label of “natural” or “organic” or perhaps endorsed by their guru, be it Mercola, or Dr. Oz, or Dr. Weil.  Regulation to allow these supplements to be tested, standards of manufacturing to avoid contamination, and a registry where health problems from the supplements occur may help protect these individuals from their worst enemy – themselves.

We as physicians, however, have a duty to our patients- a strong ethical duty of beneficence. Some mistake our ethic as “do no harm,” but it is not that. Treatments (medications, surgery) have known side effects and a risk-benefit ratio. Having a side effect does not violate beneficence as they are expected. However, if we prescribe a treatment that we know has no beneficial effect, we violate one of the basic tenants of a physician’s ethics. While government agencies do not have  ethics- physicians do, and I hope the physicians who sit on NCCAM take their ethics seriously.

A doctor of Chinese medicine, diagnosing me

Today if you get a degree in Traditional Chinese Medicine (TCM) in Beijing you will read from the original text of Li Shi Chen who first categorized the pharmacy of TCM 500 years ago. He put together various herbs and portions that are used by the Traditional Chinese Medicine (TCM) physicians even today. Using the “argument to antiquity” TCM will state that these have been used for 5000 years, and are still  of value for treating a variety of ailments.
Many of the medications prescribed in the United States today were not available when I graduated medical school in 1986. Cleaning out my desk I found samples of Viox, now off the market, a once highly touted pain medication. Vioxx came to the market in 1999, and was one of the most widely prescribed pain medicines until a few cases of cardiac deaths convinced the FDA to pull it from the market in 2004. Medications change in the modern world of medicine, we get more effective, better and less toxic alternatives. If a physician today only used medicine from 500 years ago  they would lose their medical license:

Mercury:
In China and Tibet it was thought to prolong life, help heal fractures. Mercury was so revered that the tomb of the first Emperor of China, Qin, has “rivers of mercury” so he would have a good after life. In the west it was used as a treatment for infections including syphilis.

Arsenic
Hippocrates (460-377 BCE) used arsenic as medicine. Galen (130-200 ACE) recommended arsenic to treat ulcers. In the 19th century arsenicals were used to treat acne. In the early 1900’s physicians were using arsenicals to treat pellagra and malaria, and was the mainstay treatment for syphilis until penicillin.

Morphine
A potent pain reliever was once bottled as Mrs. Winslow’s Soothing Syrup, used to keep babies quiet, and for teething. While it kept the children quiet during the Victorian Era, when children were to be seen and not heard, it may have led to  addiction at the least and some children died from overdosing.

Snake Oil
A liniment used for arthritis – and sold widely by “snake oil salesmen.” Once it was discovered that it didn’t work very well (has a bad odor also).

Old in medicine does not translate to effective, or tested, or non-toxic. Still people get the impression that TCM is not harmful, and can be used since it has been used for over 5000 years. But TCM is harmful in several ways:
Two British women who took a Chinese herbal remedy called Mu Tong have renal failure and need kidney transplants. They remedies were found to contain aristolochic acid, toxic to kidneys. Dr. Graham Lord, a consultant kidney specialist from the Hammersmith and Charing Cross Hospitals NHS Trust last year stated, “We have no idea how many people consumed this herb, but there are hundreds of Chinese herbal medicine clinics in Britain, so the number is probably substantial.”
A DNA analysis of some traditional Chinese medicines found that they contained DNA of endangered animal species. Researchers at Murdoch University in Australia found samples contained DNA from animals listed as “trade-restricted” according to the Convention on International Trade in Endangered Species Legislation. Animals clearly died for their use in TCM.

Many things are used in Chinese medicine, some endangered

The rhinoceros is nearly extinct because its horn, used in Traditional Chinese medicine, is highly prized. When the rhino horn is ground into a powder, the 16th century Chinese pharmacist Li Shi Chen said it could cure snakebites, typhoid, headaches, vomiting, and food poisoning.  Contrary to popular belief it is not prescribed as an aphrodisiac. Tested, high doses can lower fevers in rats, however, Tylenol is cheaper, works better, and does not endanger a species. The last rhinoceros of one species in South Africa was slaughtered – bled to death by removing the horn with a chain saw. There is still, in South Africa an abundance of white rhinoceros, although they are still killed for their horn.
The dose of the medication is unknown. Different plants, herbs, and species have different levels of active ingredients in them. Some ingredients, even if they have an effective dose, that dose cannot be determined without chemical analysis. You could get a dose that is ineffective, a dose that is effective, or a dose that is toxic.

TCM represents a group of medicines that have been classified in the 16th century, and have not been updated since that time. The argument to antiquity would not work with modern medicine here, as the Food and Drug Administration is keeping America safe.

A contrast TCM with modern medicine is seen in the Yew Tree. The Yew Tree is highly poisonous and was found to have an anti-cancer agent, now called Taxol, which is used to treat ovarian Cancer. Taxol was purified from the Yew tree initially and now is chemically synthesized without using the now endangered species of Yew Trees. However, TCM still uses extracts of Yew Trees for their medicines. From the synthesized taxol, and number of chemical modifications have been done to provide more effective anti-cancer agents, with lower toxicity to humans. Practitioners of TCM might point to this as a win, however, ground bark from the Yew tree to treat ovarian cancer would have only two results: either ineffective or toxic.

To diagnose a patient needing medications western medicine uses comprehensive physical examinations in combination with laboratory tests, perhaps x-ray tests such as the CAT scan. TCM physicians will look at the palms of your hands, as they prescribe herbs from Tibet, without having the foggiest notion of what the herbs/dried rhino horns/ bear gallbladders, or whatever potions, come from.

They diagnose based on the palm

Finally, the older something is does not mean that it is better. When it comes to medicine it often means it is worse. TCM fails with a part of their argument to antiquity when they cannot even substantiate how long the medicines have been used, nor can they point to any good trials of the medicines. If your doctor used a western medical text that is over 10 years old it would be considered out of date, as would the doctor. It is time that the world realize that TCM is out-of-date, ineffective, possibly toxic, and a threat to endangered plants and animals.

I look forward to the People’s Republic of China taking control of this group and forcing them to comply with standards of safety for their people and the people of the world.

The Huffington Post is at it again- by promoting a nutrition quiz from the Physicians Committee for Responsible Medicine (PCRM).  One would think that a group like PCRM would be a responsible group, with a website that would have credible information. However, PCRM is a vegan organization that promotes an anti-dairy, anti-meat, anti-seafood, anti-egg diet, and the purpose of their quiz was to help evoke those ideas.  They have also sent out news releases that are bias to  a vegetarian diet and argues for it with half-truths that do little to advance their position, and a lot to reduce their credibility.

Recent breaking news quoted a paper in that indicated that fish oil did not prevent recurrence of heart problems and “evidence fails to support their use.”  PCRM did not include the conclusion:

“However, a diet high in fatty fish (≥2 servings of marine fish per week) should continue to be recommended for the general population and for patients with existing CVD because fish not only provides omega-3 fatty acids but also may replace less healthy protein sources, such as red meat.”

PCRM is anti-fish, as well as anti-dairy, and they fail to note that the American Heart Association recommendations for two meals a day being replaced by fish.

Recently PCRM released another study showing E. Coli was in 48% of chicken bought in 10 cities by their group. What they failed to state was that the E.Coli was not the type that causes humans illness.  Further, the major outbreaks of food-borne illness have recently come from produce and peanuts – as they are grown in soil that contains E. Coli. and can be contaminated with salmonella.  There are many types of bacteria in the soil, and E. coli is a common soil bacteria, but it is not the same type as that which comes from feces.

If you were a Vegan this might be your view of food

Here is their quiz with Science and Evidence based medicine rebuttal:

(1) Skim milk has the same amount of calories as cola

Yes, they are anti-dairy, and this is suppose to scare people into thinking that dairy is bad. For those who can tolerate milk, those who are not lactose intolerant, milk is a great source of nutrients.  Cola, not so much. They say all you need is water, nothing else – and we agree, however,  milk can have plenty of nutrients in them and should not be over looked.

(2) Cheese and steak have the same amount of cholesterol.

The first question you should ask is- so what? Dietary cholesterol has a minimal effect on the blood level of  the body’s cholesterol, we have known this since I was in medical school ( 1980’s). You can see my last post about fats to see more. That different amounts of cheese as well as a porterhouse steak have the same amount of cholesterol means nothing.  Very few physicians look simply at the cholesterol level, unless it is either very high >250 – and then we look at the underlying lipid profiles.

(3) Cheese is 70% fat.

Some cheese is, but again, cheese in moderation is not a bad thing. Some cheese is not  70% fat. By the way, most nuts, which this group advocates, are also 70% fat. They go on to say that Americans are eating three times the cheese we did in the 1970′s – probably not the case for some. Cheese is something that should be used in moderation – as it is dense with calories

(4) Frequent consumption of hot dogs and bacon makes it more likely you will get colon cancer.

In the one study, that has many flaws, if you eat a diet rich in processed meats your risk of cancer is higher- by a small amount. But that is a correlation, and not necessarily a causation, and when you work out the statistics, your chance of eating that much (a lot ) is not much, and your chance of getting cancer from it is – well, we don’t know. We don’t advocate eating a lot of processed any food. They state that the recommended amount of processed meats would be “none” – we would disagree, as do bacon lovers everywhere.  The correlation is so small with this as to be stretched.

(5) Women who regularly eat soy have a lower cancer risk.

This is not necessarily so.   Comparison studies have been mixed- so the answer is, we don’t know.  PCRM based their information about population studies from Asia- but other factors these women have include (a) less obesity (b) more physically active (c) drink less alcohol (d) eat more fruits and vegetables. Until the issue becomes clearer, many doctors recommend that women who take hormonal therapy or who have estrogen-receptor-positive breast cancer avoid soy supplements because they contain high concentrations of isoflavones. But in general, it’s fine to eat moderate amounts of soy foods as part of a balanced diet. One to 3 servings of soy a day (a serving is about a half cup) is similar to an average Japanese woman’s daily soy intake. If you are taking hormonal therapy to fight off a hormone-receptor-positive breast cancer, and you are concerned about any phytoestrogen effects, ask your doctor or registered dietitian about how much soy you can eat.

(6) Salmon has cholesterol and fat

Ah yes it does, and to repeat- consuming cholesterol is not the issue. Salmon fat is high in omega-3 fatty acids and quite healthy. Eskimos and maritime Native Americans had a diet rich in salmon and the lowest rate of heart disease on earth.  There is not convincing evidence to advocate taking fish-oil capsules, there is still evidence that replacing two meals a week with fish is protective for the heart.

(7) An egg has more cholesterol than a Big Mac

Cholesterol is not an issue in diet but the 540 calories in a Big Mac compared to the 90 calories in a large egg is. The calories in a Big Mac come from 29 grams of fat, while only 5 grams of fat from an egg. While PCRM has an issue with dairy, as do some from the Paleo diet, eggs are a healthy source of protein.  If you get rid of the yolk you can get rid of a lot of the calories also. The amount of cholesterol is less important than the lower calories- and you could always use egg whites which have less fat, much less cholesterol, but a great source of protein.

(8) Milk, Beans, and broccoli are all high in calcium

This is true, and for those who need a good source of calcium but do not drink milk, there are some good alternatives. They point out that the calcium in the beans and broccoli is absorbed at a rate of  50-60%, while milk is just  32%. What they fail to point out is that 1/2 cup of broccoli contains 21 mg of calcium while 8 oz of nonfat milk contains 300 mg. That means from broccoli you get 11 mg of Calcium which is about 1 percent of the daily requirement. If you get non-calcium enriched milk you are still getting 100 mg of calcium or ten times the amount you would with broccoli.

Vegetarians may absorb less calcium than omnivores because they consume more plant products containing oxalic and phytic acids . Lacto-ovo vegetarians (who consume eggs and dairy) and non-vegetarians have similar calcium intakes. However, vegans, who eat no animal products and ovo-vegetarians (who eat eggs but no dairy products), might not obtain sufficient calcium because of their avoidance of dairy foods.

In the Oxford cohort of the European Prospective Investigation into Cancer and Nutrition, bone fracture risk was similar in meat eaters, fish eaters and vegetarians, but higher in vegans, likely due to their lower mean calcium intake.  It is difficult to assess the impact of vegetarian diets on calcium status because of the wide variety of eating practices and thus should be considered on a case by case basis.

(9) Fish and Beef have no fiber

Quite true- there is no fiber in meats. This is why a balanced diet contains fruits and vegetables. However, fish and beef contain better sources of fat absorbable vitamins, calcium, B12, protein, and other nutrients than vegetables do.

(10)  A skinless roasted chicken breast has more calories per ounce than soda or white rice

This is quite true- and mainly because of the fat content of the chicken. But chicken has more nutrients than white rice and more than soda.

PCRM also was responsible for the comments that E. Coli was found in many of the chicken products.  What they didn’t say was that the E. Coli they found were not the same as responsible for food borne illness.  In fact, the E. Coli they found was the kind commonly found in the soil, where the very plants grow that they advocate consuming. The pro-Vegan group also neglected to mention that the majority of Salmonella infections that have caused major outbreaks have come from agricultural products, including peanuts, that they advocate for a healthy diet.

It appears that PCRM is more propaganda than science. If you are going to advocate for a position, your position is diminished when you don’t tell the full story. If cornered in press conferences they avoid the answers to the questions. This is not a place to get information at all.

In the case of diet and lifestyle, there is a lot we do not know- but PCRM as a source of nutritional information is less than adequate, in that often it does not tell the whole story.  As a website for health and information it is more like a political party than a resource for those looking for evidence based medicine or science based medicine.

One of the misleading advertisements from PCRM

A doctor of Chinese medicine, diagnosing me

Underneath the white coat, however, was nothing more than a practice of “Chinese medicine.” A hoax, a fraud, and designed to extract about $300 from me to fix me using Kung Fu to rid my liver of toxins, then purchase a larger quantity of herbs to keep me from having an issue, help me lose weight, and open up the arteries going to my brain (which, if I bought this nonsense might be proof that they were closed).

With this special medicine from Tibet, my life would be saved. Only $309

I was hijacked to the Ancient Chinese Medicine Institute, not because I was looking or feeling ill.  My day had been planned around a tour of the Great Wall of China. Once on the bus, the tour guide, Sally, told us that when we were finished with the Great Wall we were going for a free “foot massage” and lecture about “longevity”  at the Institute.

During this attempted wallet extraction, my wife was having a hard time keeping a straight face. Her husband, a physician & surgeon, the ultimate skeptic, somehow got trapped into this, and she was waiting for me to begin an inquisition.  Later she told me she was surprised I had kept my mouth shut with a respectful smile and lots of nodding.

There is something compelling about “ancient Chinese medicine,” especially when they tell you it has been around for 5000 years.  It hasn’t of course, but the older something is, the more it appeals to the logical fallacy of antiquity.  The “appeal to antiquity” is an argument that states if “it” has been around long enough it must have stood the test of time, and therefore be legitimate.

Still, it would be nice to believe someone could look at you and both tell you for certain you have something wrong with you, and fix you at the same time. As a surgeon I have to do this. The difference is, we operate based on science based medicine, and hope our principles are backed with good science, and not anecdotes. The field of medicine we ascribe to has been continually modified and challenged for years, and is set to continue to evolve.

But this part of China, this “Institute” has not evolved since Sun Simiao cataloged a number of herbs a few hundred years ago.

Back to the Great Wall of China – looking at the brochure for the tour there was nothing on it about this stop.  For my wife, a free foot massage piqued her interest, although massage for me is about as enticing as tooth extraction (although a tooth extraction at least has some virtue).  But we were “on the bus” in a foreign land, and were now held captive by the tour guide, Sally.

Started out as a pleasant day on the Great Wall of China

Earlier that week we visited a Daoist temple in Xi’an where the father of Chinese medicine, Sun Simiao, is enshrined.  I thought this would be my extent of enduring a hoax of medical treatment, but alas, it was just a precursor of things to come.  Simiao produced two textbooks, one of which, 1500 years later, is still used for study of medicine.  This of course is unlike Western medicine, where our monthly journals change our idea of medicine.  Imagine if our medicine stopped 1500 years ago, and all we knew about herbs was that if we didn’t extract the active ingredients, we didn’t get to the point where we could say “you need this much of the medicine, not more, not less” but instead had to rely on a text of someone from 1500 years ago.

The much venerated Sun Simiao

We used to do that in the West. We relied on ancient manuscripts, and even made it criminal if someone were to challenge that.  Today we challenge assumptions all the time.  A medicine we think is a good one day, we discover a few years later isn’t.  What if some of the herbs were not good, or were toxic at a higher level, or didn’t work at a lower level?  No further work would be done, we would just grind up the plant, of course, you’d want to sell plants to Westerners that are from Tibet…after all, isn’t that where Shangri-la is located?

As the bus turned into the lot, Sally told us that this institute had been the private province of the Emperors of China, their staff, and only the highest ranking government officials.  Then in 1949, with the liberation, the institute was opened to the public.  Nothing like using an “appeal to authority” to attempt validation of a scam.  Since authority figures used it (they probably didn’t) then it must have been good.

She looked like a nurse, but carried a credit card machine

Entering the building, there are rows of apothecary drawers, as well as large mason jars filled with dried starfish, sea horses, and other creatures and plant parts. Next to them is a women dressed in a pink nurses outfit, complete with nurse’s cap.  We are escorted past chairs that are roped off, as they are chairs where presidents and others sat during the Olympics.  The wall is filled with pictures of world leaders meeting Chinese ambassadors, Mao, and others – I suspected to provide more “appeal to authority,” but I knew that Obama had not set foot in this place.

Lots of herbs from Tibet- we all know Tibet is where they have the best

We were escorted into a classroom where rows of lazy-boy style chairs were set up with small stools in front of them.  A young woman introduced herself and told us that we were going to get a massage and talk about medicine, but first we had to take our shoes and socks off and have our feet washed.

A group of young boys, all appearing no older than 18, came in, each bringing a bowl with plastic lining and water.  We were warned the water was hot – and it was. Floating in the water was a large “teabag” filled with some herbs from Tibet.  Apparently, herbs from Tibet are magic.  The water was indeed hot, so hot none of us could immediately put our feet in the water.

Footwashing begins, to be followed by wallet extraction

She told us to slowly place our feet inside the bowls (not that any of us could do otherwise). She told us this was good for our circulation. My wife looked at me and asked, “Is this true?”

No dear, circulation is dependent on the arteries going to the feet. If arteries had blockages secondary to atherosclerosis, there would be a fixed rate of blood flow. You could not increase that flow by placing feet into hot water.  However, with heat, the capillaries of the heated area expand to attempt to cool the feet, thus with healthy arteries there would be more flow, but that has no useful benefit whatsoever. Nerdy response, but accurate. Such a killjoy.

Finally the water cooled, enough to put our feet in – and after a long walk up and down the Great Wall, it felt good to relax in a chair and soak.  Then the young men marched back in, behind them the young woman in the pink nurse’s outfit, carrying a credit card machine and some boxes that had pictures of herbs on them.

Entice you with a foot massage and get you to buy the herbs

The young men proceeded to give a massage of the feet and legs. As they massaged the calf I wondered if they ever massaged a deep venous blood clot forcing it to break free, traveling to the lungs and causing death.  Then I coughed… and in my mind I could see it now; the 7000 miles of travel had no doubt caused the clot which now broke free and my death would happen in the Chinese Medicine Institute, and my fellow surgeons and skeptics would just wonder what I was thinking.

My wife asked the young men if they were studying, and indeed they were in the curriculum for the next six months. My wife looked at me and said, “Wow, how many years did you study to be a doctor and surgeon, and these guys get to do it in six months?” The lady overheard her and corrected her, stating that to become a “traditional” Chinese medicine doctor was a five year curriculum. Still, four years of college, four years of medical school, five years of surgical residency – my wife’s point was well taken.

Then we were told we could have a free evaluation by the distinguished faculty of the institute.  In came several “doctors” and she asked we applaud the “President” of the institute as he arrived (must be a sign of respect).  She told us that the palms reveal everything about a person. “This is not palm reading,” she said, “that isn’t science.”  Just loud enough for my wife to hear I said,  “Yes, that has only 6,000 years behind it.” Two can play the appeal to antiquity argument.

We were asked to applaud the President of the Institute as his able assistant set up the credit card machine

She then proceeded to explain that if someone had problems of the liver the palm would be yellow – if they had “low blood” and red spots indicated, “too much blood, that leads to circulation problems.”

Jaundice could be manifested in the palms, but would be manifested through the entire skin, not just the palms.  The whiteness of the palms may be a sign of anemia, but there are better signs, and too much blood is not the cause of atherosclerosis and circulatory problems.  Some grain of truth, however,  most scams have a grain of truth.

They diagnose based on the palm

My wife raised her hand for the free “assessment.” The doctor in the white coat came over with his interpreter.  Looking at my wife’s palms he asked if she had cold feet and hands sometimes, and then asked about her menstrual cycle. The doctor deduced that she has kidney problems, and of course, with the right kinds of herbs, not only will her menstrual cycles improve (they are, as she told them, like clockwork, regular and not an issue),  but she would feel better immediately. He took out a prescription pad and began to write.  My wife asked if the herbs were a tea form, or a pill.  They brought her a box and showed her a sample of the pills.  She said she didn’t want them- he kept his prescription.

I asked for an assessment.  He immediately went from my palms to my belly, announcing that I had toxins in my liver. He asked if I had pain in the back of my neck – I said that I did, when I had a long day of surgery.  The surgery part didn’t register.  Through the interpreter he told me that the toxins in the liver were affecting the arteries to my brain, laying down clogs, and that is why the back of my neck hurt. Of course the main arteries to the brain, the carotid arteries are in the side of the neck, not the back, and where he was pointing to was below where the vertebral arteries went to the brain, but that wasn’t the point.

Which doctor was diagnosing witch doctor

Whatever was I to do? He told me that he could fix me immediately.  He would use Kung Fu to remove the toxins from my liver. “Kung Fu?” I asked.  The interpreter said, “Yes, like Bruce Lee.  The doctor will use his energy to remove the toxins from your liver, then you can take some herbs that will keep the liver free of toxins and help you lose weight.”  And how much would this Kung Fu Panda inspired technique cost?  Just over 4,000 RMB (a little over $300).

I declined, of course.  Then looking over our group I saw the president of the institute using his Kung Fu on a lady by her forehead.  It reminded me of Benny Hinn curing someone in his church. I almost expected the “doctor” to yell “Fresh” as his kung fu energy was zapping out the toxins from that woman’s brain.

Next to us was a man who was told his pulses were low.  Using acupuncture, several needles were placed into his wrist, and as the needles were taken out, the doctor who spoke English  very well, said, “See, already the circulation is better.”

There was more conversation with the fellow tourist’s wife and I heard the doctor say, “Oh, you don’t need surgery. That’s Western medicine, you need Chinese medicine.” He explained with herbs he could shrink her uterus to the size of a bean (since they don’t use x-rays, CAT Scans, ultrasounds, or even do autopsies on their patients I am not certain how he knows or could confirm this).  Next thing we knew, she and her husband were off with the doctor for a “private consultation.”

The entire tour group was waiting for this couple to come back.  It took them a good hour and when they came back they had a large grocery sack filled with herbs. This woman will make her way merrily back to the Philippines, secure in the knowledge that she will not need surgery for her uterus that has a benign tumor.  Of course, I thought to myself, there is absolutely no liability if the Chinese doctor was wrong.

So here are a few facts when you hear things like “ancient Chinese medicine” and it being thousands of years old. It isn’t.  The herbs they use were mostly described 1500 years ago.  Since then science has taken herbs, plants, fish, trees, and other assorted products in nature – purified the active components, or tested and found out some were just not active.  For example: Digitalis, a drug we use to use a lot for heart failure, can be found in about 20 different plants. The dose of digitalis is important – use too much and the person goes into heart block and dies, use to little and you have no effect.  It is quite dose dependent – something you don’t want to rely on a plant alone, but want it purified and quantitated. Most recently from the Yew tree, Taxol was found– one of the first potent agents against Ovarian Cancer – again, scientists found the active ingredient in the bark (saving forests of Yew trees), purified it and it is also dose dependent.  Eat too much Yew bark and you won’t cure ovarian cancer, you will die.  Eat too little and it will just slowly poison you.  When you talk to these “doctors” they will tell you they use the original writings from 1500 years ago — really? If a doctor quotes an article from a journal ten years ago, other than to show for historical purposes – they are considered not being up to date.

What about acupuncture? There has NEVER been a study showing that acupuncture has more than placebo effect.  Meaning, when you compare acupuncture with random placed needles, or pressure, there is no difference.  Hence, there is no Chi, or field that the needle person can do anything with. Did you hear about the story where someone didn’t need anesthesia, just surgery — all bogus, didn’t happen.  And acupuncture is first seen about 2000 years ago, although much more used 150 years ago (the stuff from 2000 years ago is speculation, we have good data from 150 years ago). The Journal of Chinese Medicine says the earliest they have indication of it is 2000 years ago .

Using Kung Fu to take out poisons or toxins? Don’t know where this came from — since they were hijacking tour buses, they probably either were appealing to Westerners who watch Bruce Lee movies, or they had seen the “healing” done in evangelical churches.

Many things are used in Chinese medicine, they like sea creatures most of all

As I was in the parking lot of the “institute” I quietly let out a loud flatus.  My wife was horrified but I told her, “I’m passing toxins.” You are what you eat- and I was just fed a lot of what I just passed- pure and utter BS.

The "Institute"

When the Archives of Internal Medicine published the article “Red Meat Consumption and Mortality” all I could think of is “here we go again.”

First to go through this paper- which is a statistical population study from the Health Professionals Follow-up Study (HPFS) and the Nurses’ Health Study (NHS). Of the 140,000 combined participants they tossed out 20,000 because of a history of the diseases reported or those who did not fill out the forms perfectly.

To start with – this is not a study where people were followed from baseline to death to see if what they ate contributed, and determining amounts along with following other variables as they progress (lifestyle issues with exercise, smoking, etc). This instead is a study based on food questionnaires, and statistical analysis. Correlation does not imply causation.

One has to be careful with epidemiological studies, as they are not  proof of a cause, rather they point to a number of variables that might be involved to form a hypothesis. It is these same types of statistical studies that told us that women should use hormone replacement therapy because it prevents heart attacks in 1991, only to be told 11 years later that it might cause heart attacks. It is a sampling bias of those individuals who choose to participate in the studies that led to the erroneous conclusions.

The second issue with these studies is the ability of the food questionnaire and its accuracy. This has been studied – that is, the ability of people to recall and fill out what they ate. We do this in our office all the time- ask people what they eat—and since we are involved in weight loss and healthy lifestyle here is what we can say: people have no ability to remember what they ate, how much they ate much beyond the last day. When studied by others, looking at the questionnaire (FFQ or Food Frequency Questionnaire) in the Nurses’ Health Study was found to be useless. As reported by others, the accuracy of the questionnaire compared to reality was unacceptable.

For example, 20 per cent of the nurses reported living on 1200 calories per day or less, and low intake of red meat, and 20 percent report over 2000 calories a day.

In the study the first table showed that the highest reported red meat consumption was associated with smoking, drinking more, obesity, and higher calories. Oh wait- have you ever heard that smoking, obesity, eating more calories, or drinking more might lead to an early death? Perhaps you have, in fact, there are some correlations (which don’t imply causation) for these, and there are some great prospective studies showing that obesity leads to early death.  Of course, in any statistical paper you can remove the confounding factors – and THEY DID NOT in this paper.

One other cute correlation- in the data, those who report eating the most red meat had the lowest cholesterol levels. Yes, that is odd isn’t it. Readers of this blog know that cholesterol and meat have less to do with one another – and that isn’t a statistical issue, that is just basic biology.  Eating more meat does not mean you will have a higher cholesterol – having bad genetics does.

Here is what three systematic reviews of prospective studies show in the relationship between saturated fat and heart disease- zip. There has been a consistent lack of an associated between saturated fat intake and heart disease. While this new study statistically makes the argument that changing diet would decrease events from heart disease and cancer, when looked at (references below) none of the pooled studies show a change in that risk relationship. And, when some studies have shown a change in risk, when the data was examined there was no difference in mortality. While some say red meat clearly is bad, the evidence is anything but clear. Proving again that population studies, without isolating the variables, without having a scientific basis, are worthless.

Finally, the science of red meat—what do we know? Red meat is a large category of meats includes everything from bacon (considered “processed” by some and delicious by others) to cows raised on grain, and cows raised on grass. Grass fed beef have higher levels of omega-3 fatty acids. Consuming different red meats mean you are consuming different levels of ingredients. Lumping them together is just sloppy science.

Nothing like great grill marks on a steak

Skeaff CM, Miller J. Dietary fat and coronary heart disease: summary of evidence from prospective cohort and randomised controlled trials. Ann Nutr Metab 2009;55:173–201.

Mente A. A systematic review of the evidence supporting a causal link between dietary factors and coronary heart disease. Arch Intern Med 2009;169:659–69.

Siri-Tarino PW, Sun Q, Hu FB, Krauss RM. Meta-analysis of prospective cohort studies evaluating the association of saturated fat with cardiovascular disease. Am J Clin Nutr 2010;91:535–46.

Dr. Esselstyn noted the risk of heart disease in rural China was low in the 1970’s – and presumed that they didn’t have a “western diet.” Now there are two flaws in his population statistics: First in the 1970’s in rural China most individuals were starving to death – it was the end of the cultural revolution and any source of food that could be found and eaten was. The second issue is if you examine data from The China Study you will see that heart disease mortality was lowest in the rural communities that were able to eat more meat. In The China Study (again, I promise this will be a topic later) – they used mortality statistics from the time during the end of the Cultural Revolution. Rural China was starving then, all trees had been used for fuel, there were virtually no birds left (combination of deforestation and hungry humans) and rice was used for the army.

Dr. Esselstyn then talks about Norway during World War 2, when they were occupied by the Nazi Germany, and how that heart disease diminished as the Norske were forced to eat a plant based diet. That was a great assumption to make, but when examining the data from Norway there are a few interesting factoids – Meat consumption dropped 60% but fish increased 200 per cent. Vegetables and potatoes increased but sugar decreased by half. And when the data is put to a microscope in 1942 and 1943 when mortality declined, animal proteins were still higher than before the war. It appears that Norway suffered from increasing fish (great source of Omega 3 fatty acids) and foraged for foods such as wild greens, grew and ate a lot of potatoes, but had a low amount of sugars and almost no margarine (I don’t know a respectable Norwegian today who cooks with margarine). The sad part of the war was the increase of mortality from infectious diseases – especially pneumonia (my mother’s cousin who fought for the resistance died of this, as did many of his comrades).

Norway in WW2 ate a lot of fish- and this roe was popular

He followed these patients for up to 12 years – his numbers are confusing as he started with 24 patients and six dropped out (leaving 18). One of the 18 died from his heart disease (leaving 17). At ten years there were 11 patients. They did angiography and reported a regression of 11 lesions with 14 remaining stable.

Angiogram- xray - of a plaque. Not enough to do surgery on though

When any study talks about a “cardiac event” it means to most of us a heart attack. If you have a small lesion in a coronary artery and then that lesion accumulates a blood clot that is what a heart attack is. The blood clot (from platelets – a sticky component of blood that helps you clot ) blocks the flow of blood to the heart muscle. If the clot blocks blood flow for a long time then the heart muscle dies and you have a myocardial infarction, if it opens up then all you have is a heart attack. This has little to do with the size of the lesion, and more to do with the complex chemistry of the coagulation system. Hence, taking aspirin a day or Plavix is more beneficial.

The other major problem with the study is that these individuals were on lipid lowering medications. Dietary reduction of lipid level (Cholesterol and lipoproteins such as VLDL, HDL) is about ten per cent on average, but never more than twenty per cent. However, lipid-lowering medications – such as Crestor – can remarkably lower levels of the lipids. In addition, lipid-lowering medications are best for reducing inflammation. They are anti-inflammatory to blood vessels, meaning in addition to lowering the lipids and cholesterol, their main effect is to reduce the chance of having a “coronary event.”

Crestor shown to be effective at decreasing the plaque in arteries

One of my cousins, preventing heart disease and eating fat

There is a lot of pseudoscience in medicine, and the reason that we have medical treatments that are quackery is because of the industries built around them.  This was made evident by the recent issues with the HCG diet. Contrary to what reasonable people would think, the new FDA ban on over-the-counter HCG did not shut down the industry built around HCG. The FDA states “HCG has not been demonstrated to be effective adjunctive therapy in the treatment of obesity. There is no substantial evidence that it increases weight loss beyond that resulting from caloric restriction, that it causes a more attractive or “normal” distribution of fat, or that it decreases the hunger and discomfort associated with calorie-restricted diets”

There is an entire HCG diet industry kept alive by those who make their living promoting this weight loss method.  What has gone away is the ability of non-physicians to sell the drops, tablets, troches – all HCG must be prescribed by a physician. Within two miles of my home there are five places that advertise HCG diet. None of these places is a physician’s office. Whether the FTC or FDA cracks down on these is another matter.

These weight loss clinics sell the HCG –either by breaking the law and prescribing without a license, or they are finding a physician who will write the script without seeing the patient.   For a physician to write a prescription without seeing a patient is not only bad medicine it is unethical- and, at least in Arizona, would probably result in the physician being sanctioned by the medical board.

Because the FDA has, without equivocation, stated that HCG is not useful for weight loss, proponents of HCG are now circulating “articles” of “studies” showing that HCG works. But the HCG controversy provides a microcosm of how proponents of woo-woo medicine (medicine that is based on pseudoscience) use “studies” to promote their treatments.

The article that should have put the nail in the coffin of HCG was written in 1976 in the Journal of the American Medical Association. The paper was a study of 202 patients treated with either HCG or saline placebo.  The physicians administering the medicine did not know if they gave the patient HCG or if they gave the patient the saline (salt water). The patients did also not know.  All patients were placed on the 500 calorie diet.  At the end of the study, there was no difference between those who were given HCG and those who were given placebo in terms of weight loss. There was also no difference in fat loss. There was no evidence that those who had received HCT were more or less satisfied, and the dropout rate was the same. Thus, they could not prove what the advocates of HCG said- that people who use HCG along with the diet will feel better and adhere more to the diet, and that there was no more or less fat loss among those patients. This was the article that, temporarily, put the nail in the coffin for HCG.

The reasons physician-scientists consider this article a good article are: (a) The study was randomized so the patients did not know what they were getting.  This eliminates bias of the patient. (b) The physicians did not know what the patients were getting – eliminating the bias of the physician (c) The results were reviewed by non-bias staff (d) the study was prospective- meaning the subjects were followed ahead of time so the authors could not manipulate the data either way. (e) the article appeared in a journal that is peer reviewed, meaning editors read the article for its content, have the ability to ask the authors to submit raw data, and can spot bias.

That article, along with others, put away the HCG diet industry for a while, until 2007. In 2007 a book was written about HCG – by Kevin Trudeau, called “The Weight Loss Cure ‘they’ don’t want you to know about.”  The Federal Trade Commission fined Trudeau 37 million dollars for making false statements in this book. Oddly enough book is still sold, and many of the “HCG weight loss coaches” make money selling it.  The book is bunk, by the way – total, complete and utter nonsense promoting HCG.

This silly book resurected a bad diet

Contrast the great article in JAMA with an article that the HCG coaches are currently recommending, by Dr. David Bryman, an osteopath from Scottsdale, who published a non-randomized study with a higher protein low calorie diet- showing the HCG had more weight loss (The Bariatrician – 2010 Vol 25, page 11). The problems with this study are several: first there is no randomization, second there is no control, third there is no blinding, and fourth there is a clear bias, fifth the article is retrospective  – so it can come to the conclusion it likes. The article is worthless.

Having “journals” gives people who practice pseudoscience (be it chiropractic, acupuncture, homeopathy) a sense of legitimacy. Sadly, those journals do not follow scientific principles of research, evidence or science-based medicine.

Confirmation bias is a bias hard to overcome. This is seen in the HCG diet industry. If you attribute weight loss to HCG, then everyone who loses will confirm your bias that it was the HCG.  It is clear that it is the diet – whether it is a high protein 800 calorie, or the original 500 calorie diet, that will provide the weight loss.  However, the people who sell it, or the books and meal plans, are convinced that the HCG is doing the work- in spite of the lack of science supporting their claim.  Much like acupuncture, or homeopathy – if someone believes it, and then is confirmed by placebo effect, it is difficult to overcome that bias.  Add in that a part or all of one’s living is made by some pseudo-scientific endeavor and the pseudoscience becomes a religion.

It is difficult to convince someone their “experience” is not accurate or even that their “experience” isn’t what they think it is.

HCG shows the ultimate “placebo” effect.  A placebo is a pill or injection that has no active substance in it – commonly a sugar pill or a saline injection.  Placebo comes from Latin, meaning “I shall please.”  To test whether a chemical, hormone, or some agent works, you have to test it against a placebo. Some people, 35-55% of them, with some diseases, will have an equal effect with a placebo as with the hormone tested (in this case HCG). Placebo works best with nebulous things that cannot be measured- like appetite. As was shown in the JAMA study when HCG was compared with saline injections, there was no difference.  HCG works by placebo effect.

The problem is that HCG is not a placebo.  HCG is a hormone, one that has effects that can be long lasting and harmful. We don’t know if the hormone has a tumor promoting effect as other hormones do (estrogen with breast and uterine cancer and testosterone with prostate cancer, HCG may have tumor promoting effects – it certainly can increase venous thrombosis). The other problem is physicians who prescribe this are giving legitimacy to a treatment that does not work, and can cause harm. They are also placing themselves at risk by stating they have evaluated a patient

As with all pseudoscience- there are people who firmly “believe” in this without a shred of legitimate evidence. Proving that having a degree (MD, DO, RN) does not make one a skeptic, and clearly degrees do not teach people how to think and apply the scientific method. Many in pseudoscience use the logical fallacy of an appeal to authority – e.g.- a doctor prescribed the HCG, and a nurse is my coach so it must be good.

In terms of the other scams in medicine- Homeopathy is one that actually has a board sanctioned by the State of Arizona. It isn’t odd that Arizona is so backward, after all, it is the wild west. But I like the quote from Dr. Zina Pitcher, when the State of Michigan tried to force the University of Michigan to have a homeopathic school:

…shall the accumulated results of three thousand years of experience be laid aside, because there has arisen in the world a sect which, by engrafting a medical dogma upon a spurious theology, have built up a system (so-called) and baptized it Homœopathy? Shall the High Priests of this spiritual school be specially commissioned by the Regents of the University of Michigan, to teach the grown up men of this age that the decillionth of a grain of sulphur will, if administered homœopathically, cure seven-tenths of their diseases, whilst in every mouthful of albuminous food they swallow, every hair upon their heads, and every drop of urine distilled from the kidneys, carries into or out of their system as much of that article as would make a body, if incorporated with the required amount of sugar, as large as the planet Saturn?

The power of the purse did cause the school to come to the University of Michigan, although eventually the Supreme Court did state that the Regents of The University of Michigan were not answerable to the legislature.  The homeopathic school was merged into the medical school in 1920′s – and homeopathy was gone for a while. Sadly- it is back.

Heart artery plaque- low fat diet doesn't prevent this

Never has it been more clear that publishing a paper in a respected journal can lead to a career. Even if the science has changed it. It has been 15 years since Dean Ornish published his data showing a 3 percent reduction in the plaques seen by coronary angiograms on a select group of patients who followed his diet and “lifestyle” plan.  To be exact: they found 1.75% improvement after one year and 3.1% improvement after five years.  Where the control group increased by 2.3% in one year and 11.8% at five years. This was a group of 28 patients who followed his diet to the letter.

In 15 years no one has reproduced that data. No one. In medicine we see a lot of data come through, when it is not reproduced, or unable to be reproduced by others we look at it with a very jaundiced eye. Or to be blunt – we don’t believe it. Yet, his data, with all the issues it has- is still touted by a few in the popular press as “proof” that the “low fat” works. We have levels of evidence in medicine, and while Ornish attempted to get to the highest level of evidence, by having a control group – he fell short with several major statistical issues: (a) his study does not contain enough people to be anywhere nearly significant (b) one cannot rely on angiographic photographs which are interpreted in many different manners (c) one cannot control outside factors, exercise, BMI, smoking cessation.

In contrast, we now have an entire group of lipid medications. A recent study in New England Journal of Medicine showed how that Crestor had produced a regression of plaque in 63% of the individuals.

Lets be clear- the medication data is using far more sensitive instruments to measure plaque. Intra-vascular ultrasound where they thread a tiny ultrasound probe into the artery and  measure the plaque precisely.   In the Ornish data, he used photos of angiograms ( show two cardiologist the same angiograms and you will get two different interpretations of it – angiograms are not precise). The medications show specific reductions in plaque- not everyones – unlike Ornish. It is rare that anything does 100 per cent to everyone.

When looking at angiograms- like Ornish did- the interpretation of them is so variable, that no scientific publication today would accept that data, or its interpretation. The small amount of plaque reduction is too small to be anything but observer bias.

Two views of the same image- angiogram interpretation is flawed

Still, from one old paper- Dean Ornish has made a career, being the anti-Atkins, and riding the anti-cholesterol, low-fat band wagon with the same religious fervor as Keyes did thirty years ago (see my earlier post about that).

The difficulty is this: science has caught up with us, and we know a lot more about how plaque forms and doesn’t form. We know that dietary cholesterol is far less important that what the liver makes. We know that the dietary component may be far more related to the triglycerides – and they are raised far more by the grains and pastas that Ornish loves.

Still, Ornish is the lead health-blogger for Huffington Post, has influenced Bill Clinton (see the previous post) and is favorably mentioned by Dr. Oz. He still argues against those who advocate any “low carbohydrate” solution, based on his “empiric” data.

Personality, the willingness to believe in  your hypothesis no matter what science says, and the desire by the public to see “natural” leads to a great career in politics, and entertainment. For most scientists, Ornish’s paper isn’t a breakthrough, but borders on confabulation.

The first written code for physicians

There are four pillars of Physician Ethics – and it is from these that modern physicians make decisions. It is from these we judge ourselves, and – if called upon, our colleagues. Those Four Pillars are autonomy, nonmaleficence, beneficence, and justice.

Dr. Burzynski is a physician who runs a cancer clinic in Houston that specializes his own invention of cancer therapy called antineoplastons. He has been in the news lately because one of his supports has threatened a 17 year old blogger in Great Brittan with legal action. There is plenty of discussion in the blog world about Dr. Burzynski’s therapy- and I wrote a short piece about this in another blog- but was asked to discuss this from the ethical perspective of a physician.

Autonomy
As a physician we have ethical obligations, and expectations to our patients. One of them being autonomy – people are truly free to choose their treatment, but must have the information that is required to make a choice. More about innovation and research in a bit, but there are plenty of cancer patients who willingly submit themselves to treatment that has no proven benefit beyond a lab.

Nonmaleficence
Another key tenet for physicians is nonmaleficence – to not use our skill and knowledge to harm a patient. Deliberate harm would be to put a patient at risk for a treatment we know doesn’t exist. Risk associated with procedure does not count as “doing harm” unless the procedure has no hope of benefit. We know conventional chemotherapy has the potential to cause illness, and even death – I know this personally because my brother died four years ago after his first dose of chemotherapy put his frail body into septic shock, from which he did not recover. Some suggested that because my brother had metastatic lung cancer that the chemotherapy robbed him of the few months he had- and therefore the physician went against nonmaleficence by administering a therapy that would not do benefit. But that chemotherapy was not to prolong Jimmy’s life- certainly there were no illusions that it would cure him – but he was suffering horribly, and it was hoped a reduction of the tumor burden would give him some relief. In surgery- we know there are risks involved, but if a patient suffers a known complication from surgery- it is not that the physician did harm – the surgeon did not violate the Hippocratic oath (most of us never took that oath, but we adhere to many of its principles, including nonmaleficience). In Dr. Burzynski’s case – if he knows the treatment won’t work, then he is doing harm – but if he believes it works he is not guilty of nonmaleficience.

Beneficence
This is the tenet that as a physician it is our duty to act in the best interest of the patient. This means to directly intervene, if possible, for the comfort and well-being of our patient. The key is that we are not the ones who judge this- it is the patient, and not the physician, that determines this – and involves other aspects besides health and survival. As a physician we must be trusted, we must be truthful, and we must respect confidentiality of our patients above all else. It is our goal to ease pain and suffering- and not cause it. And while not all providers and patients weigh this the same- this is not judged by the physician, only by the patient.

Justice
This is not judgement- this is the concept of fairness to all. While there are limited resources- we must find a way to make these resources to our patients in a fair manner. The transplant world deals with this in how organs are distributed among those in need.

Innovation and Research
Dr. Burzynski claims that he has a cure, or better treatment for cancer than anyone else. There have been phase 1 and phase 2 trials of these treatments, but no published phase 3 trials comparing them to standard treatments. But let us step back, because innovation is not the same, in medicine, as research.
Innovation is different than research. In surgery we innovate every day- no two operations are the same, and sometimes we do operations that we have never done before. That requires an informed consent with a patient- and an open and honest discussion. Some feel it involves an Institutional Review Board (IRB) – but it doesn’t This is where the patient has autonomy, this is where the surgeon has nonmaleficence, this is where he uses his Beneficience and justice to bring something to the patient.

That is different than research. In research, which is the systematic acquisition of data for the purpose of generalizable inference – this requires equipoise. Equipoise requires that even though we believe our treatment might be best, we provide different treatment arms so that it can be tested. Clinical equipoise is satisfied if there is an uncertainty in the medical community regarding the therapy (antineoplastons) and this allows the clinical investigator to do a trial until there is statistical evidence to convince the medical community about this treatment.

Because Burzynski has not satisfied the medical community with equipoise, we question the treatment- and can only be convinced by a phase 3 trial. Until he does- the medical community, and others- will remain skeptical of his treatment. Some have demanded he release his data to peer reviewed journals. That, of course, cannot be done. We cannot compel Burzynski to release his data. But that his data has not been reproduced by the accepted academic world in the United States will be an ongoing issue.
This means patients have to pay the high cost of his research, the high cost of getting treatment from him and that is because insurance companies won’t pay for treatment until that treatment passes through our standard method of evaluating therapies.

Given those pillars- what is Dr. Burzynski, as a physician ethically obligated to do? While he may not be required to do anything, medical ethics would require that he enter patients into phase 3 trials, comparing large groups of patients to random treatment arms, to determine if his treatment has more merit than others. If he does this than the medical community is required to respond, and open up those treatments to patients who wish to participate. Doing that in his own clinic, without having other non-vested physicians also treat him – is not satisfactory.

We believe strongly in ethics for physicians – and from an ethical point of view, Dr. Burzynski meets some of the pillars – but without a full and open process that can be evaluated by physicians that are not involved (and there are plenty of physicians who have stated his treatments are not as efficacious as standard treatments) – Dr. Burzynski fails at justice. If he has a cancer treatment better than others- and the only way it can be obtained is by paying thousands of dollars- then this represents a failure of one of the pillars of medical ethics.