PHS-II: Vitamins E, C, Beta Carotene, and Cancer
What is it about vitamin E that seems to bring out the worst in medical researchers? Once again, I find myself compelled to defend it -- for the umpteenth time. My goodness, there have been three studies in the last month alone "proving" that vitamin E offers no health benefits. First, health findings from the Physician's Health Study II (PHS-II) on vitamin E and vitamin C in terms of preventing cardiovascular disease were released last week. In case you missed the news, which was widely promoted in the media, according to the study, neither vitamin E nor vitamin C supplementation reduced the risk of major cardiovascular events, and that there was no support for the use of these supplements for the prevention of cardiovascular disease in middle-aged and older men. These results are, of course, nonsense, and I dealt with them in my health blog last week Do Vitamins C and E Aid Cardiac Health?.
Then there was the SELECT study on vitamin E and prostate cancer released earlier this month that my good friend, Mike Adams at Natural News, did a great job of eviscerating.
Which leaves the third study (actually, the PHS-II study once again but involving different data, a different conclusion, and a brand new release), which found that the use of vitamin E or C supplementation provides no benefit in terms of cancer prevention. What is it about vitamin E that brings out the worst in so called intelligent people? In any case, this conclusion, too, is nonsense -- and for many of the same reasons as the other two studies. But since the media has promoted this nonsense on three separate occasions in the last month, I will deal with it once again in some detail in this newsletter.
The Physicians' Health Study-II (PHS-II)
Let's begin by taking a look at PHS-II. The Physicians' Health Study-II was designed to test four popular nutrients -- vitamin C, vitamin E, beta-carotene, and a multivitamin -- primarily for their effectiveness in preventing cardiovascular disease, prostate cancer, and total cancer. Certainly, this was an admirable goal that no reasonable person could quibble with. Participants were recruited from physicians who had already participated in PHS-I, which was used to determine if aspirin and beta carotene could prevent heart attacks and other cardiovascular events. The reason physicians were chosen for these studies is that it was reasoned that, as a group, physicians would report their medical histories and health status more accurately than participants drawn from a general population. Also, it was determined that they would be more likely to identify possible side effects of the study agents. Incidentally, the results of PHS-I were that aspirin significantly reduced the risk of a first heart attack and that beta carotene had no effect.
The first warning sign that PHS-II was designed to fail
So far, nothing to complain about. PHS-II sounds like a reasonable attempt to determine a reasonable health benefit for some natural supplements. As if! The first warning sign was listed in the study recruitment guidelines . "To take part in PHS-II, men who were taking individual supplements containing more than 100% of the RDA of vitamin E, vitamin C, beta-carotene, or a multivitamin had to forego the use of such supplements for the course of the trial." This requirement is utter nonsense. RDAs are set increbibly low. They are actually estimates, based on surprisingly limited studies, often involving small numbers of people and incomplete data. They are designed to prevent the immediate onset of disease (scurvey, rickets, etc.); they play no role in maintaining long term health and preventing long term chronic illness. Yes, I understand why medical researchers keep insisting on it -- but it absolutely turns the concept of alternative health treatments on its head and pretty much negates any positive results before you even start. Why?
I've actually covered this issue many times before, but since it involves one of my favorite metaphors, let me repeat.
In almost all cases, alternative therapies for cancer are administered as part of a comprehensive program or protocol. Nevertheless, when members of the medical community decide to test the validity of a particular treatment, they insist on separating out the pieces from the whole and testing them in isolation. Thus they feel the need, as in PHS-II, to stop the test subjects from using any other supplements at anything beyond ridiculously low RDA levels so those other nutrients would have no impact on the study results.
Although this may at first appear to be reasonable and "scientific," it is not. In fact, it is akin to deciding to test a prospective football quarterback by putting him on the field with no one else playing offense. The "alternative approach," of course, would be to put him on the field with an entire team and see how he plays. If he scores, if he leads the team to victory, if he wins the Super Bowl, we would say he is a good quarterback. To many people, that would seem to make sense -- unfortunately, not to anyone in the medical community.
The "medical approach," on the other hand, is quite different. "How can we really tell if he's any good if there are other players on the field? Great receivers could catch lousy passes, and we'd never know. A great offensive line could make our quarterback look good by blocking so well that he has all the time in the world to find his receivers. No! The only way to truly tell if he's any good is to put him on the field alone against an entire all-pro defensive team, and then see how he does." And, of course, the moment the ball is hiked, he's swarmed over and killed.
So far, so good; but we have a hanging chad that needs to be dealt with. And that is that drugs pass this kind of testing. How do they do it? Quite simply, drugs are "magic bullets." Returning to our football analogy, we can indeed put our quarterback out on the field all alone to test his skills -- but this time armed with an AK-47 assault rifle. Of course, as soon as the ball is hiked, he shoots the entire defensive team and walks across the goal line. He wins! Unfortunately, although he scores, there are side effects. The other team is dead, and the game is over -- but he did score.
Look, just like football is a team game (with the team only as strong as its weakest link) so too is alternative therapy when it comes to treating cancer. On occasion, you may get good results using just one component or another, but overall you will get the best results when you run the program as a whole. To isolate components of a program from the whole is to treat them as drugs. That's not what they are, and they will fail that test by definition.
Another point to keep in mind is that alternative therapies are not subtractive. They are "additive." An alternative treatment that would be dismissed as ineffective because testing showed it to be only 10% effective in isolation might nevertheless be an invaluable part of a comprehensive program that contained seven 10% components -- giving you a 70% chance of overcoming your cancer. But the medical establishment deliberately chooses not to test alternative therapies in this way -- thus condemning all seven components with the "quackery" label. So the only way you hear about effective alternatives is by word of mouth or anecdotal evidence. Clinical studies are almost designed to fail alternative therapies by definition.
And that's why the requirement that physician's in PHS-II who were using any supplements (such as any multivitamins they were taking) beyond RDA levels had to forego those supplements for the course of the trial was a deal killer even before the study started.
So how do you test alternative protocols? You test the entire protocol as it is being used in the alternative health community to see if you get the same results. Then, if you do, you can start pulling out pieces of the protocol one at a time to see if anything changes. If you pull a piece and nothing changes, you can conclude that particular piece was not important. But you start with the complete protocol to see if you can match the claimed result and set a benchmark. You don't arbitrarily strip the program down according to your best guess and then trash the entire protocol because your limited version didn't work.
But it gets even worse!
Scientists chose to test the wrong supplements
As was done in PHS-I, the physicians were sent calendar packs containing either placebos or 16 possible combinations of the four supplements. Each participant was assigned one of those combinations of vitamin E (400 IU of synthetic alpha-tocopherol), beta-carotene (50 mg Lurotin), vitamin C (500 mg synthetic ascorbic acid), a multivitamin (Centrum Silver), or their placebos. (Not to be too sarcastic, but when you look at the actual supplements participants received as indicated by the bold type above, I'm not sure what the difference was between the supplements and the placebos.) It should be noted that an additional part of the protocol was that the Vitamin C and the multivitamin (and their placebos) were taken daily, whereas the vitamin E and beta-carotene (and their placebos) were taken every other day. Excuse me, but who takes their vitamin E or beta carotene supplements every other day? That would be like having surgery to remove a tumor and having the doctor decide to only remove half the tumor. Do we actually have to do a study to figure out how effective that would be? But I digress. The key point here is that the researchers' selection of supplements was fundamentally flawed and guaranteed to fail from the outset. Specifically:
400 IU of synthetic alpha-tocopherols
Synthetic vitamins can be derived from either natural or chemical sources. What makes them synthetic is that they undergo a process of "conversion," either as a result of the extraction process or as the result of pure chemical buildup. Synthetics are at best about 50% as effective as natural vitamins and, in many cases, actually suppress the body's ability to absorb the natural portion of the vitamin. Note: light passing through a natural vitamin always bends to the right due to its molecular rotation. Synthetic vitamins behave differently. That same ray of light splits into two parts when passing through a synthetic -- one part bending to the right (d for dexorotary), the other to the left (l for levorotary). A natural vitamin E fraction, for example, is easily identified then by the "d" in "d-alpha-tocopherol." the synthetic by the "dl" in "dl-alpha-tocopherol." But does this matter in terms of efficacy?
Most definitely! Synthetic alpha tocopherol, as I mentioned above, is already proven to be at best, only 50% as effective as the natural form -- and in some studies actually harmful, this is not an unimportant distinction. For more on the differences between natural and synthetic vitamin E, check out:
- Alpha-tocopherol Transfer Protein and Vitamin E Adequacy
- The Case Against Vitamin E
- Vitamin E One More Time
- Benefits of Vitamin E
But there's more!
You see, neither synthetic dl-alpha tocopherol nor its "natural" form, d-alpha tocopherol are actually vitamin E. Vitamin E, as are most vitamins, is a naturally occurring "complex" that never exists in isolation in nature. (Why is this concept so difficult for medical researchers to understand?) Vitamin E consists of at least 4 tocopherols (alpha, beta, gamma, and delta) and 4 tocotrienols (alpha, beta, gamma, and delta).
So how did vitamin E come to be defined as just one of its eight components? Quite simply, a number of years ago, researchers looking at the E complex saw that alpha tocopherol was the predominant component of the complex so they decided, "It must be the most important. So we'll call that one piece Vitamin E and ignore the other components." (A fascinating bit of logic when you think about it.)
Well, over the last few years, researchers have come to understand that alpha tocopherol is not only not the most important component, it is, at best, number five in the pecking order-- trailing all of the tocotrienols and gamma tocopherol in importance.
So the question of the day is, "If researchers actually know that vitamin E consists of a minimum of eight components, with alpha tocopherol not even cracking the top half in importance, why are all these current studies basing their conclusions on supplementation with this marginally beneficial isolated component -- and a synthetic version at that?" And the problem is that no matter what answer you come up with (ignorance, stubbornness, or malice), it's not good.
50 mg Lurotin
What the heck is Lurotin? It is a synthetic form of beta carotene made by extracting benzene rings from acetylene gas, and then attaching the benzene rings together to form 100% all-trans-beta-carotene. There is no natural food source in the world that contains 100% all-trans-beta-carotene. As it turns out, natural beta-carotene is made of two molecules -- all trans beta carotene and 9-cis beta carotene. In sources such as Dunaliella salina, the trans and cis forms of beta carotene are split approximately 50/50.
At one time, studies suggested that synthetic beta carotene actually was absorbed better and worked better than natural forms of beta carotene. But other studies in both animals and humans have demonstrated far more conclusively that natural beta carotene provides benefits that that the synthetic form cannot match. And more to the point, studies have shown that pre-cancerous changes in people reverted to normal tissue with natural beta-carotene supplements, but not with synthetic supplements. Incidentally, Lurotin is the same synthetic form of beta carotene that was used several years ago in a test of smokers that "proved" that "beta carotene" increases your risk of lung cancer.
I'm sorry, synthesized acetylene gas is not beta carotene, and it certainly isn't a complete beta-carotene containing both the trans and cis forms. But beyond that, it is not a complete carotenoid complex. Like vitamin E, beta carotene does not exist in nature as an isolate. In nature, beta carotene always comes as part of a carotenoid complex, not in isolation. There are more than 400 carotenoids in a single carrot, for example.
And as a side note, Lurotin is manufactured by BASF, the massive German chemical company. Is this a problem? Only if you consider the fact that BASF is one of the primary sponsors of Codex Alimentarius , a set of international trade laws designed to take away your right to purchase the herbs and supplements of your choice -- no matter what country you live in.
500 mg synthetic ascorbic acid
The question of synthetic VS natural ascorbic acid aside, the key issue here is dosage at 500 mg. The problem is that all significant studies on vitamin C -- particularly those done by Linus Pauling -- were done at 4,000 mg a day administered intravenously. Let me make this brain-dead simple. If you're trying to evaluate a health protocol, you actually have to use the protocol in question if you wish to assess it. You can't arbitrarily cut doses by 87% and conclude the protocol doesn't work.
This study is akin to trying to determine whether you can lose weight on a low calorie diet of 1,000 calories a day by feeding people 8,000 calories a day! That's just plain stupid!
And Pauling studies are hardly isolated. The results have been duplicated in other models, both animal and human.
Not to pick on Centrum Silver, but let's be honest here -- Centrum Silver is the quintessential low-end, grocery-store multi-vitamin in the world. It never met a synthetic vitamin isolate it didn't like and has incorporated them wherever possible in its formula -- as in synthetic E, synthetic beta carotene, polysorbate 80, FD&C Blue 2 Aluminum Lake, FD&C Red 40 Aluminum Lake, FD&C Yellow 6 Aluminum Lake, and synthetic sodium selenate. With all the vitamin supplements in the world to choose from in testing efficacy for preventing cancer, why in the world would you choose Centrum Silver unless you were looking to guarantee that your test would fail from the outset? For more on multivitamin supplements, check out my alternative health newsletter on multivitamin/mineral formulas.
Do vitamin E and beta carotene protect against cancer, or not?
So now we know all the reasons that we can throw out the recent negative study results on vitamin E, C, and beta carotene. But that still leaves the key question unanswered: do these supplemental vitamins protect against cancer, or not? And the answer?
Who knows? But the PHS-II study does not come close to answering the question. As we have seen, both the protocols and implementation of the study were flawed from the get-go, with the negative results guaranteed even before the study began.
Interestingly enough, previous research has shown that people who eat diets rich in vitamins E and C have a lower risk of cancer. For example:
- Dietary vitamin E and prostate cancer
- Dietary vitamins C and E and oral cancer
- Dietary vitamins C and E and bladder cancer
- Dietary beta carotene and prostate cancer
- Dietary beta carotene, vitamin C, and risk of prostate cancer
- Dietary beta carotene and lung cancer
The bottom line is that cumulative evidence for the value of dietary vitamins in preventing cancer is overwhelming. And yet the recent PHS-II study categorically says these vitamins have no benefit, and the press ran with that story. But, as we've seen, the quickest of cursory scans of the study reveals two major disconnects. The study used synthetic forms of the vitamins -- forms known to be counter-productive. And the study used dosages below the norm. The negative results of the study could easily have been predicted by anyone who had the barest understanding of health and nutrition.
Would the results have been different using naturally sourced full complex supplements? Who knows? The researchers deliberately chose not to test them. But my guess based on the reading of informal studies over the years and the dietary studies cited above is "yes."
The only question unanswered, then, is why the researchers deliberately chose to set up the study in a way guaranteed to fail?