Cureality | Real People Seeking Real Cures

Stents, defibrillators, and other profit-making opportunities

16. April 2006 William Davis (2)

As a practicing cardiologst, every day I receive a dozen or more magazines or newspapers targeting practicing physicians, not to mention the hundreds of letters, postcards, invitations to "talks", etc. that I receive. All of these materials share one common goal: To get the practicing cardiologist/physician to insert more of a manufacturer's stents, defibrillators, prescribe more of their drugs, etc.

This is a highly effective and profitable area. Pfizer's Lipitor, for instance, generated $12.2 billion just last year alone. This kind of money will fund an extraordinary amount of marketing.

I'm on the www.heart.org mailing list, a website for cardiologists. I'd estimate that 90% or more of their content is device-related: discussions of situations in which to insert stents, the expanding world of implantable devices, the ups and downs of various drugs. Rarely are discussions of healthy lifestyles, exercise, nutritional supplements, part of the dialogue.

How can you protect yourself from the brainwashed physician, flooded with visions of all the devices he can put in you, all the drugs that can "cure" your disease? Simple: information. Be better informed. Ask pointed questions. The idiotic lay press tells you to ask a doctor about his education. That's not generally the problem. Some of the best educated doc's I know are also the most flagrantly guilty of profiteering medicine.

Ask your doctor about his/her philosphy about the use of medications, devices, etc. If their word is God, take it or leave it, run the other way.

Will radiation kill you?

16. April 2006 William Davis (4)

Several people have asked me lately if radiation is truly dangerous. These conversations were sparked by an editorial comment made on a column I wrote for Life Extension Magazine's April, 2006 issue on "Three ways to detect hidden heart disease".

Among the methods that were discussed in this piece was, of course, CT heart scanning. Anyone who is involved with CT heart scans Quickly recognizes the spectacular power of this test to uncover hidden, unsuspected heart disease, literally within seconds. In 2006, there's really nothing like it for the every day person to have hidden heart disease detected and precisely quantified.

Yet, the "rebuttal" to my article claimed that the broad use of heart scans was only my personal view and that, in truth, radiation kills people.

NONSENSE! If an ovarian cancer is discovered by a CT scan of the abdomen, is that unwise use of radiation? If pneumonia or lung cancer is discovered on a chest x-ray with minimal radiation exposure, have we performed a disservice. Of course not. In fact, these are often lifesaving applications of radiation.

Can radiation be used unwisely with excessive exposure? Of course. The 64 slice CT angiograms are just an example of this. Dr. Mehmet Oz announced on Oprah recently that this was a test to be used for broad screening of women for heart disease. This is wrong. The radiation required for a full 64 slice CT angiogram test is truly excessive for a screening application. You wouln't want to get breast cancer from your mammogram, would you? The radiation from a 64-slice CT angiogram is similar to that of a heart catheterization in the hospital--too much for screening. This is not to be confused with a CT heart scan for a calcium score performed on a 64 slice device. I think this can be performed with acceptable radiation exposure.

Think about what would happen, for instance, if you had your heart disease undetected, had a heart attack, and went to the hospital? During your hospitalization, you'd likely get five chest x-rays, a heart catheterization, perhaps one or more nuclear imaging tests, maybe even a full CT scan (with far more radiation than a screening heart scan). The amount of radiation of a heart scan is trivial compared to what you obtain in a hospital.

So take it all in perspective. The low level of radiation required for a simple heart scan (not an angiogram) does not by itself substantially add to your lifetime risk of radiation exposure. It may, in fact, save your life or reduce your life long exposure to radiation.

Are you using bogus supplements?

16. April 2006 William Davis (0)

I consider nutritional supplements an important, many times a critical,part of a coronary plaque control program.

But use the wrong brand or use it in the wrong way, and you can obtain no benefit. Occasionally, you can even suffer adverse effects.

Take coenzyme Q10, for instance. (Track Your Plaque Members: A full, in-depth Special Report on coenzyme Q10 will be on the website in the next couple of weeks.) Take the wrong brand to minimize the likelihood of statin-related muscle aches, and you may find taking Lipitor, Zocor, Crestor, etc. intolerable or impossible. However, take a 100 mg preparation from a trusted manufacturer in an oil-based capsule, and you are far more likely to avoid the inevitable muscle aches. (Though, of course, consult with your doctor, for all it's worth, if you develop muscle aches on any of these prescription agents.)

Unfortunately, you and I often don't truly know for a fact if a bottle from the shelf of a health food store or drugstore is accurately labeled, pure, free of contaminants, and efficacious.

One really great service for people serious about supplements is the www.consumerlab.com website. They are a membership website (with dues very reasonable) started by a physician interested in ensuring supplement quality. Consumer Lab tests nutritional supplements to determine whether it 1) contains what the label claims, and 2) is free of contamination. (I have no reason to pitch this or any other site; it's just a great service.) They recently found a supplement with Dr. Andrew Weil's name on it to have excess quantities of lead!

What Consumer Lab does not do is determine efficacy. In other words, they do a responsible job of reporting on what clinical studies have been performed to support the use of a specific supplement. However, true claims of efficacy of supplement X to treat symptom or disease Y can only come with FDA approval. Supplements rarely will be put through the financial rigors of this process.

If you're not a serious supplement user, but just need a reliable source, we've had good experiences with:

--GNC--the national chain
--Vitamin Shoppe--also a national chain
--www.lifeextension.com or www.lef.org--A great and low-priced source, but they do charge a $75 annual membership that comes with a subscription to their magazine, Life Extension (which I frequently write for) and several free supplements that you may or may not need. Again, I'm not pitching them; they are simply a good source.
--Solgar--a major manufacturer
--Vitamin World
--Nature's Bounty
--Sundown

There are many others, as well. Unfortunately, it's only the occasional manufacturer or distributor that permits unnacceptable contamination with lead or other poisons, or inaccurately labels their supplement (e.g., contains 1000 mg of glucosamine when it really contains 200 mg). I have not come across any manufacturer/distributor who has systemtically marketed uniformly bad products.

It really helps to have someone to lean on

16. April 2006 William Davis (0)

Among my patients are several husband and wife teams, both of whom have heart disease by some measure. Several couples, for instance, consist of a huband who's received a stent, survived a heart attack, or has some other scar of the conventional approach. The wives generally have a substantial heart scan score in the several hundred range.

There are a few couples for which the roles are reversed: wife with bypass, heart attack, etc. and husband with a substantial quantity of coronary plaque by CT heart scan.

From them all, however, I've learned the power of teamwork. When both wife and husband (or even "significant other") are committed to the effort of controlling or reversing heart disease risk, the likelihood of success is magnified many-fold. Everything is easier: shopping for and choosing foods, incorporating supplements in the budget, taking vacations with a healthy focus, following through and sticking with your program.

Several of the couples have succeeded in obtaining regression of plaque for both man and woman. Both have reduced their heart scan scores and, as a result, dramatically reduced the potential for future heart attack and procedures.

Unfortunately, I will also see the opposite situation: One spouse committed to the program but the other indifferent. They may say such things as "You can't control what happens in the future." Or, "There's no way you can get rid of risk for heart disease. My doctor says it's hereditary." Or, "I've eaten this way since I was a kid. I'm not changing now for you or for anybody else."

Such negative commentary can't help but erode your commitment to health. Most of us recognize these sorts of comments as self-fulfulling and self-defeating.

What should you do if you have an unsupportive partner? Not easy. But it really can help to seek out a supportive partner, whether it's a friend, relative, or other significant person in your life. Of course, not everybody can find such a person. Perhaps that's another way our program can help.

I'd like to hear from anyone who does obtain substantial support of someone close, or if you are struggling to do so.

Five foods that can booby trap your heart disease prevention program

14. April 2006 William Davis (0)

There are several foods that commonly come up on people's lists of habitual foods that are truly undesirable for a heart disease prevention program. Curiously, people choose these foods because of the mis-perception that they are healthy. My patients are often shocked when I tell them that they are not healthy and are, in fact, detrimental to their program.

I'm not talking about foods that are obviously unhealthy. You know these: fried foods, greasy cheeseburgers, French fries, bacon, sausage, etc. Nearly everyone knows that the high saturated fat content, low fiber, and low nutritional value of these foods are behind heart disease, hypertension, and a variety of cancers.

I'm talking about foods that people say they eat because they view them as healthy--but they're not.

Here's the list:

1) Low-fat or non-fat salad dressings--Virtually all brands we've examined have high-fructose corn syrup as one the main ingredients. What does high fructose corn syrup do? Triggers sugar cravings, makes your triglycerides skyrocket (causing formation of abnormal lipoproteins like small LDL), and causes diabetes. The average American now ingests nearly 80 lbs of this evil sweetener per year. You're far better off with olive, canol, grapeseed, or flaxseed based salad dressings.

2) Breakfast cereals--If you've been following these discussions, you know that the majority of breakfast cereals are sugar. They may not actually contain sugar, but they contain ingredients that are converted to sugar in your body. They may be cleverly disguised as healthy--Raisin Bran, Shredded Wheat, etc.

3) Pretzels--"A low-fat snack". That's right. A low-fat snack that raises blood sugar like eating table sugar from the bowl.

4) Margarine--Forget this silly argument about which is worse, butter or margarine. Which is worse, strychnine or lead? Both are poisons to the human body. Who cares which is worse? Fortunately, there are now healthy "margarines" like Smart Balance and Benecol that lack the saturated fat or hydrogenated fat of either.

4) Bananas--Bananas are not all that intrinsically unhealthy. The problem is that people will say to me, "Oh sure, I eat fruit. Two bananas a day." What I hear is "I don't really eat fruit with high nutrient value, fiber, and reduced sugar release. I reach for only bananas which yield extreme sugar rises in my blood and are low fiber." Aren't they high in potassium? Yes, but there are better sources. Cut back if you are a banana freak.

Why the mis-perceptions? A holdover from the low-fat diet days and marketing from food manufacturers are the principal reasons. Of course, foods are meant to be enjoyed, but be informed about it. Choose foods for the right reasons, not because of some cleverly-crafted marketing campaign.

Breakfast of champions?

12. April 2006 William Davis (1)

I spend time every day educating or reminding patients that breakfast cereals are not health foods.

I see jaws drop in shock when I tell them that, in my opinion and despite the marketing claims, Cheerios, Raisin Bran, Shredded Wheat, and the like do not yield health benefits. In fact, they do the the opposite: dramatically raise blood sugar and trigger an adverse cascade of events that eventually leads to diabetes and heart disease.

Why the health claims in advertising? Because these products contain insoluble fiber, the sort that makes your bowels regular. Yes, your bowels are important to health, too. But the benefits end there.

Breakfast cereals are a highly refined, processed food that are not good for your plaque control program. What they are is a highly profitable, multi-billion dollar business, deeply entrenched in American culture ("They'rrrre grrrrrreat!"--Tony the Tiger; "There's a whole scoop of raisins in every box of Post Raisin Bran!" Bet you remember them all.)

I find it particularly upsetting when I see the stamp of approval from the American Heart Association on some products. Gee, if the Heart Association says it's good for you, it must be true! Don't you believe it. The American Heart Association relies on corporate donations, just like any other charity.

If you must eat breakfast cereals, refer to www.glycemicindex.com for a full database of glycemic indexes. You can look up a specific product and it will list its glycemic index, or sugar-releasing properties. You should try to keep glycemic index of thea time, several times a week. She would throw herself on the floor, curl her toes, slam her heels against the floor, and rub the tops of her feet against the carpet, all while screaming the entire time. These were horrible for her to endure, and horrible for my wife and myself to watch. This went on for a year.

From what I read, the symptom was perhaps like foot spasms associated with carpopedal syndrome or tetany. But her blood work did not support that at all. Calcium level was normal (10.2 mg/dL); 25-Hydroxy-vitamin D low (23.5 ng/ml); 1,25 dihydroxy-vitamin D normal (24.7). Despite some vitamin D deficiency, I was assured by medical professionals that nothing supported a vitamin D cause of these particular spasms, so vitamin D was dismissed. Because her calcium level was normal, they told me she did not have tetany, and vitamin D could not be the cause of the pain.

All medical consultants were stymied. I made another research effort and found a 2003 article on WebMD that stated vitamin D has been found to have some link to basic, unexplained muscle and bone pain. By chance, vitamin D was the next supplement we had at home to begin giving my daughter to treat her autism. So, in April 2007 we began giving my 4 year-old profoundly autistic daughter Vitamin D supplements. Her foot spasms which had plagued her for a year diminished within days and disappeared within three weeks. She has not had a spasm in over two months.

In addition, we noted clear improvements in her autistic condition which appear to be from the vitamin D supplements. Eye contact went from zero to fantastic. Her vocalizations increased markedly (still only babbling; she remains completely nonverbal). She appears even happier than previously (she has always been a somewhat happy child). (Please note that my wife and I have tried many dietary supplements over the past 1.5 years guided by a doctor and dietician who both specialize in autism. We honestly state that this is the only thing that has ever had a positive effect on my daughter. We have seen nothing else work.)

My daughter and vitamin D have a complicated relationship. By all counts, looking at her lab work and general condition, vitamin D should have played no role in those excruciating foot fits. And yet it is apparently exactly what is involved in them. And, my wife and I believe at the same time her autistic condition has improved from the vitamin D. The foot fits and her autism appear linked; it was not just a coincidence that this autistic child has those mysterious foot spasms, and the link appears to be vitamin D.

And so I wonder if this is just the tip of the iceberg, if perhaps there is more to know about my child's relationship with vitamin D and what that might mean for her autism. Does she have a specific vitamin D-related disorder? If so, might direct treatment of it also improve her autism further? These are the questions I would like to pose to a vitamin D specialist who could perform a medical work up on my daughter. Please let me know if you know of anyone in the Northern Virginia/Washington DC area. Also, where is the best place to get vitamin D? Thank you for your time.

Sincerely,
Paul, Washington, D.C.

Dear Paul:

I know of no such specialist in the Washington area, indeed no vitamin D/autism expert exists in the world. As far as a specific "vitamin D disorder," linking her spasms, autism, and vitamin D, the world's English language medical literature contains no description of such a disorder. From your daughter's case, it sounds as if PediaSure was her only regular source of vitamin D. If so, her spasms began two weeks after stopping the small amount of vitamin D contained in PediaSure. The spasms continued for a year, ending a few days after you started giving her vitamin D again, this time in the form of a supplement. Several weeks after restarting vitamin D, both you and your wife noticed an improvement in her autism. To my knowledge, this "case report" - your daughter's - is the first ever published.

As no medical literature has ever been published on any of this, all you can do is give her enough vitamin D to get her 25-hydroxy-vitamin D, known as 25(OH)D, into high normal ranges and then wait and hope. Vitamin D's extraordinary mass-action pharmacology implies that simply providing more substrate ([25(OH)D] will help children with low enzyme activity produce more activated vitamin D (calcitriol) in their brains. The vitamin D theory of autism is not simply that vitamin D deficiency in gestation or early childhood causes the disorder. Instead, the theory holds that a quantitative or qualitative abnormality exists in the enzyme system that activates vitamin D.

It could as simple as the normal variation in the enzyme, an enzyme whose activity would vary in a normal or Gaussian distribution, much like height. Some people are tall, some are short, most are in the middle. The same may be true of the enzyme that forms activated vitamin D (calcitriol), some children have a lot of enzyme and some only a little; most are in the middle. As the substrate [25(OH)D] the enzyme metabolizes fell over the last 20 years with sun-avoidance, more and more children on the low end of the enzyme curve are effected by marginally low 25(OH)D levels, explaining both its genetic basis and exploding incidence.

At this point, all your daughter needs is a physician willing to periodically measure her 25(OH)D. Then you can safely supplement your daughter with doses higher than the current Upper Limit for children (2,000 IU/day). You did not tell me your daughter's weight but, assuming she weighs about 30 pounds, even without 25(OH)D blood tests, you can safely give her 50 mcg/day which is 2,000 IU per day. In fact, the U.S. government says this dose is safe for children over the age of one. Life Extension Foundation sells 250 of the 1,000 IU capsules for about ten bucks with powdered vitamin D inside. The powder is tasteless and dissolves easily in juice. Bio Tech Pharmacal, of Fayetteville, Arkansas, told me they were going to be making a 1,000 IU capsule. Or you can get 1,000 IU capsules in a pharmacy or at Costco and crush them. A Canadian firm is now making vitamin D liquid, called Ddrops, with 1,000 IU per drop, but their mail order web site is not yet easily accessed. Beware of cod liver oil; do not use it because vitamin A inhibits the actions of activated vitamin D, and due to the potential for low-grade vitamin A toxicity.

Remember, more and more researchers now believe autism is a progressive, inflammatory, disorder. That is, the inflammation probably progressively destroys brain tissue as the child ages. As I said in my recent paper, I think there is a chance that vitamin D may have a treatment effect in young autistic children if given in adequate doses, due to its anti-inflammatory properties, and its ability to upregulate glutathione, the master antioxidant that also chelates (binds) and then helps excrete heavy metals like mercury. Unfortunately, I see no way, even if the vitamin D/autism theory turns out to be true, that vitamin D can regenerate brain tissue. However, if it stops the inflammation, and cell death, the brain could then begin to develop and learn. These are big ifs. However, you have nothing to lose by trying, the worst that will happen is that it will not help and vitamin D will be added to the long list of false-hope treatments.

Actually, there is a worse possibility. Say the parents of a three-year-old autistic child decide today that vitamin D is nonsense, another false hope, and that I'm a quack. They decide not to give vitamin D supplement their autistic child, who is probably - like your child - vitamin D deficient. Then, it turns out five years from now that scientific evidence shows vitamin D does indeed help. By that time, the child will be eight and will have suffered additional, irreparable, brain damage. In my mind, that is more tragic than another false hope.

Dear Dr. Cannell:

After that article appeared in the Toronto paper, I started my four-year-old son on 1,000 IU of vitamin D two weeks ago. So far the only thing I noticed is that after about ten days, he didn't seem so miserable. The thing that has always broken my heart is that look of sadness and suffering on his face. After about two weeks of vitamin D, I noticed he seemed less miserable. I wouldn't say he looks happy now but that look of misery seems to be gone. Will it come back? I'm not sure I can take it if it comes back. What else might happen? Also, last summer we noticed he seemed to get better, but then he got worse in the fall. We never thought about it until we read about vitamin D.

Susan, Toronto, Canada

Dear Susan:

I don't know. I think all parents have had their heart pierced by that look at one time or another. I would advise increasing the dose to 2,000 IU per day, making sure it is cholecalciferol and not ergocalciferol, and having your doctor order a 25(OH)D every two months to see if he needs higher doses. You want to get his blood level up to between 50 ng/ml and 80 ng/ml (In many countries outside of the USA, that would be reported as between 125 and 200 nmol/L.) and keep it there, summer and winter, and that may take more than 2,000 IU/day in the winter. If vitamin D has a treatment effect, it will take many months to see its full effect. As you noted, if the theory is correct, autistic children who spend time outdoors in the summer should show some seasonal improvements - if they don't wear sunblock and they expose enough of their skin to generate significant amounts of vitamin D.

Dear Dr. Cannell:

I resent you calling autism a tragedy. My son is not a tragedy and I'm glad he was born and is in our lives. He is our joy. Autism is not a tragedy.

Emma, London, England.

Dear Emma:

I'm glad he is your joy and I believe you. I'm new to the autism field and was not aware how much thought and speech control exists in the discussion of the disease. Nevertheless, I have a few politically incorrect questions. If autism is a joy, I assume you would like other parents to have an autistic child? If autism is such a joy, why is there a huge industry forming to prevent and treat it? At the risk of sounding insensitive - apparently one of the most serious charges leveled in the autism debate - autism is a tragedy. As I pointed out in my paper, research shows that having an autistic child, puts the family under more emotional stress than having a child with a fatal illness.

Dear Dr. Cannell:

Who are you to write an article on autism? You didn't even publish it in a medical journal. You are not with a university. You have not published very much. You have no expertise on autism. No autism experts support your theory. There is no evidence to support the theory. Shouldn't you leave this to experts before you give parents more false hopes?

Mary, Trenton, New Jersey.

Dear Mary:

You are right, I am a nobody; just ask my ex-wife. In the Toronto Globe, I explained why I have not yet submitted the paper. As far as giving false hopes, I've thought about that charge. Right now, regardless of what advocacy groups say, autism is rather hopeless. That is, no treatment, including vitamin D, has been shown to materially affect the clinical course of autism. As a psychiatrist, my observation is that people would rather live with a false hope than with no hope.

Furthermore, if autistic children began taking vitamin D, the worse that can happen is that a period of false hope will followed by dashed hopes and then parents will be back to hopelessness. In the meantime, they will have made their child vitamin D sufficient. Vitamin D deficiency is a serious problem in childhood.
Postgrad Med J. 2007 Apr;83(978):230-5.

The Telegraph, Why is Vitamin D So Vital?

As far as the theory having no support from experts, Dr. Richard Mills, research director of the National Autistic Society in England, was quoted in the Telegraph article on the autism/vitamin D theory: "There has been speculation in the past about autism being more common in high-latitude countries that get less sunlight and a tie-up with rickets has been suggested - observations which support the theory."

Finally, you said there is no evidence to support the theory. I assume you meant there is no proof. The first statement is absolutely false, the second absolutely true. As I detailed in my paper, there is a lot of evidence to support the theory. In fact, if anyone can come up with an autism fact, that the theory cannot explain, I'd like to know about it. Even the announcement of a link between television viewing and autism supports the theory. Furthermore, the TV/autism link is actually evidence of a treatment effect. That is, if autistic children who play outside in the sunshine more - watching less TV - have less severe illness, it may be due to the Sun-God, who bestows her precious gift of calcitriol into the brains of children playing outside in her sunlight but not into the brains of children watching TV inside in the darkness.
Natl Bur Econ Res Bull Aging Health. 2007 Winter;(18):2-3.

As far as proof the theory is true, there is, of course, none. In medicine, proof means randomized controlled human trials, the gold standard for proof. However, proof is the last step, not the first. First comes evidence, then comes a theory, then comes researchers disproving those theories. It works that way. Sometimes we never get to the last step, proof. For example, please point me to a single randomized controlled human trial proving cigarette smoking is dangerous? Instead, the convincing evidence of smoking's dangerousness lies in epidemiological studies, not randomized controlled trials. Proof, or disproof, of the autism vitamin D theory will take years, years during which young autistic brains will continue to suffer irreparable damage. Perhaps vitamin D' powerful anti-inflammatory actions will help prevent that damage, perhaps not.

It's something of a Pascal's wager, betting on vitamin D instead of the existence of God, risking your child's brain instead of eternal damnation. "If you believe vitamin D helps autism and turn out to be incorrect, you have lost nothing -- but if you don't believe in vitamin D and turn out to be incorrect, your child will suffer irreparable brain damage."

John Cannell, MD
The Vitamin D Council
9100 San Gregorio Road
Atascadero, CA 93422

This is a periodic newsletter from the Vitamin D Council, a non-profit trying to end the epidemic of vitamin D deficiency. If you don't want to get the newsletter, please hit reply and let us know. This newsletter is not copyrighted. Please reproduce it and post it on Internet sites. Remember, we are a non-profit and rely on donations to publish our newsletter and maintain our website.

Michael Pollan Podcast

15. August 2007 William Davis (3)

I just found this great podcast of an April, 2006 National Public Radio (NPR) interview with Omnivore's Dilemma author, Michael Pollan:

Author Michael Pollan: 'The Omnivore's Dilemma'

available at http://www.npr.org/templates/story/story.php?storyId=5342514

The Science Friday segment is a great encapsulation of all the fascinating spins this wonderfully insightful author has on human eating habits and the developing distortions of food choices, much magnified by the food manufacturing industry.

One of my favorite comments from Pollan: "The USDA should be called "The Department of Corn," referring to the ubiquitous dissemination of corn products into livestock and human foods that has increasingly led to the enormous health problems we're all facing in 2007.

Are you addicted to fructose?

13. August 2007 William Davis (1)

Try a little experiment:

Side by side, try a yogurt made with fructose or high fructose corn syrup as one of the first ingredients on the label along with a yogurt made without fructose.

Yoplait and Dannon brands, for instance, fit the bill for fructose. Several brands do not use fructose products. Many of these are the unflavored or unsweetened versions. You may therefore have to add some blueberries, strawberries, or some other fruit for some flavor. ( I doubt that you would add high fructose corn syrup.) Add nuts, seeds, flaxseed, or oat bran to either.

Many people who do this will notice a peculiar effect: The fructose or high fructose corn syrup containing product is, to most, delicious. It also triggers a desire for more. You can't have just one--you've got to have another, or you've got to eat something else.

The non-fructose containing product is more likely to generate satiety, a feeling that you've had enough.

If you experience this effect, the solution is simple: avoid fructose and high fructose corn syrup. I believe that the most worrisome health effect of fructose is this hunger-increasing aspect, difficult to document, perhaps impossible to measure, but a great boon to the food industry who practice an "eat more" philosophy to increase revenues year after year.

Perhaps you will also see weight drop (since you will be more satisfied), see triglycerides drop (since fructose raises triglycerides), and maybe obtain all the downstream benefits of reduced triglycerides (higher HDL, less small LDL, less VLDL, more rapid clearance of post-prandial lipoproteins).

Most people who follow this idea gain better control over appetite, lose weight, and do better in health, including in their Track Your Plaque program.

Chicken Little

11. August 2007 William Davis (1)

Clinical studies can be designed in a number of ways. The ease and cost of these studies differ dramatically, as does the confidence of the findings.

The most confident way to design a clinical study is to tell neither the participants nor the investigator(s) what treatment is being offered, then to administer treatment or placebo. Neither the people doing the research nor the participants know what they are receiving. Of course, there needs to be some way to find out what was given at the end of the study in order to analyze the outcome.

This is called a “double-blind, placebo-controlled” clinical study. While not perfect since it tends to examine a treatment phenomenon in isolation (e.g., the effects of a single drug in a select group of people), it is the best sort of study design that is most likely to yield confident results, both negative and positive. This sort of design is followed, for instance, for most prescription drugs.

There are pitfalls in such studies, of course, and some have made headlines lately. For instance, beyond tending to examine single conditions in a select group of participants, a double-blind, placebo-controlled study can also fail to uncover rare effects. If a study contains 5000 participants, for instance, but a rare complication develops in 1 person out of 20,000, then it’s unlikely such an ill-effect will be observed until larger numbers of people are exposed to the agent.

Another pitfall (though not so much of study design, but of human greed) is that study outcomes that are not favorable can be suppressed by simply failing to publish the results. This has undoubtedly happened numerous times over the years. For this reason, a registry has been created for all human clinical trials as a means to enforce publication of outcomes, both favorable and unfavorable.

Despite its weaknesses, the double-blind, placebo-controlled study design remains the most confident way to show whether or not some treatment does indeed yield some effect. It is less prone to bias from either the participant or the investigator. Human nature being what it is, we tend to influence results just to suit our particular agenda or interests. An investigator who knows what you are given, drug or placebo, but owns lots of stock in the company, or is hoping for special favors from the pharmaceutical company sponsor, for instance, is likely to perceive events in a light favorable to the outcome of the study.

Now, most studies are not double-blind, placebo-controlled studies. These are notoriously difficult studies to engineer; raise lots of ethical questions (can you not treat a person with an aggressive cancer, for instance, and administer a placebo?); often require substantial numbers of participants (thousands), many of whom may insist on payment for devoting their time, bodies, and perhaps even encountering some risk; and are tremendously expensive, costing many tens of millions of dollars.

For this reason, many other study designs are often followed. They are cheaper, quicker, may not even require the active knowledge or participation of the group being studied. That’s not to say that the participants are being tricked. It may simply be something like trying to determine if there are more heart attacks in people who live in cities compared to rural areas by comparing death rates from heart attack from public records and population demographic data. Or, a nutritional study could be performed by asking people how many eggs they eat each week and then contacting them every month for 5 years to see if they’ve had a heart attack or other heart event. No treatment is introduced, no danger is added to a person’s established habits. Many epidemiologic studies are performed this way.

The problem is that these other sorts of study designs, because they generate less confident results, are not generally regarded as proof of anything. They can only suggest the possibility of an association, an hypothesis. For real proof to occur, a double-blind, placebo-controlled may need to follow. Alternatively, if an association suggested by a study of lesser design might, by reasons of a very powerful effect, be sufficient. But this is rare. Thalidomide and catastrophic birth defects are an example of an association between a drug and fetal limb malformation that was so clear-cut that no further investigation was required to establish a causative association. Of course, no one in their right mind would even suggest a blinded study.

Where am I going with this tedious rambling? Lately, the media has been making a big to-do about several studies, none of which are double-blind, placebo-controlled, but were cross-sectional sorts of observations, the sorts of studies which can only suggest an effect. This happened with Dr. Steve Nissen’s study of Avandia (rosiglitazone) for pre-diabetes and risk for heart attack and the recent study suggesting that cancer incidence is increased when LDL cholesterol is low. Both were observations that suggested such associations.

Now, those of you following the Heart Scan Blog or the www.cureality.com website know that we do not defend drug companies nor their drugs. In fact, we’ve openly and repeatedly criticized the drug industry for many of its practices. Drugs are, in my opinion, miserably overused and abused.

But, as always, I am in the pursuit of truth. Neither of these studies, in my view, justified the sort of media attention they received. They are hypothesis-generating efforts—that’s it. You might argue that the questions raised are so crucial that any incremental risk of a drug is simply not worth it.

Despite the over-reaction to these studies, good will come of the fuss. I do believe that heightened scrutiny of the drug industry will result. Many people will seek to avoid prescription drugs and opt for healthy changes in lifestyle, thus reducing exposure to costs and side-effects.

But beware of the media, acting as our Chicken Little, reporting on studies that prove nothing but only raise questions.

Do statin drugs reduce lipoprotein(a)?

Breakfast cereals and toilet paper