Exploring chronic disease
22 Mar 2008
Maybe vitamin D isn’t the answer after all.
Not only does the above statement ring true, it’s also the title of a recent post on “Dr. Len’s Cancer Blog” – a website written by Dr. Len Lichtenfeld, Deputy Chief Medical Officer for the national office of the American Cancer Society, in order to facilitate communication with the public on important issues related to cancer.
Dr. Lichtenfeld, as described by his website, is a frequent spokesperson on a variety of cancer-related subjects, and serves as a liaison for the Society with many professional and public organizations. He’s also a board certified medical oncologist and internist who was a practicing physician for nearly 20 years and serves on several national committees focused on physician payment, the quality of medical care, and the role of health information technology in healthcare delivery.
In the blog entry described above, Lichtenfeld attempts to explain to the public why the American Cancer Society does not plan to advise the American public to take extra vitamin D supplements in the name of preventing cancer (this is in contrast to the Canadian Cancer Society which has, unfortunately, urged citizens to ingest more of the secosteroid).
Lichtenfeld begins his discussion by taking a close look at one of the most recent studies on cancer and vitamin D – a study conducted by the National Cancer Institute. The first study to actually look at the relationship between measured vitamin D in the blood and subsequent total cancer deaths, it failed to show an association between baseline vitamin D status and overall cancer risk in men, women, non-Hispanic whites, non-Hispanic blacks, Mexican Americans, and persons younger than 70, or 70 years or older.
“The key finding of the study was that there was no impact of vitamin D levels on the overall risk of dying from cancer, when comparing groups based on where they lived or what season their blood test was drawn (spring and summer would be expected to increase vitamin D levels, compared to winter),” Lichtenfeld explains. “Vitamin D had no impact on cancer deaths when various racial/ethnic groups were examined.”
Of course, Lichtenfeld does acknowledge that the research team found a significant reduction in colorectal cancer among subjects with higher levels of vitamin D (25-D) in their blood. Yet, in a decision that reflects his neutrality on the subject, Lichtenfeld makes it clear that such findings will need to be confirmed by future studies before the American Cancer Society considers vitamin D as a possible remedy for colorectal cancer.
No doubt he is aware of a similar study conducted by Jacques Rossouw at the National Institutes of Health, whose group tracked the effects of vitamin D on 46,282 postmenopausal women with colorectal cancer, while monitoring the women over a long period of time. Rossouw’s team found “absolutely no indication of an effect of calcium or vitamin D [on cancer] — zero.”
With such conflicting data emerging on vitamin D and colorectal cancer, no wonder leaders such as Lichtenfeld are taking a step back to see if they might be missing part of the vitamin D puzzle.
Such contradictions may also be why, with good reason, Lichtenfeld appears to be taking a long, hard, look at how several other studies on vitamin D have been conducted, with a keen eye towards bias.
“Many of the other studies have tried to infer vitamin D levels through a variety of means, such as asking about dietary habits or inferring a vitamin D level based on descriptions of outdoor activities.”“Many of the other studies have tried to infer vitamin D levels through a variety of means, such as asking about dietary habits or inferring a vitamin D level based on descriptions of outdoor activities,” comments Lichtenfeld. His concerns about such research methods are well-grounded, as studies attempt to infer levels of vitamin D rather than measure them are notoriously bad at coming up with accurate results.
Thus, Lichtenfeld suggests that the recent study by the National Cancer Institute, a study which found that vitamin D offers no overall benefit in fending off cancer, should bear more weight than other studies on the subject, as it was done prospectively – meaning that participants were followed looking forward, and actual blood tests were used to measure the amount of vitamin D in their blood.
Futhermore, Lichtenfeld seems to understand the urgent need for long-term studies on vitamin D. He agrees with editorialists who have suggested that it may take longer than 6-12 years to accurately assess the effects of vitamin D on study subjects – especially since, as he comments, it can take many years for a cancer to develop.
Those of us familiar with the Marshall Protocol wholeheartedly agree with Lichtenfeld in this regard. It’s clear that future studies on vitamin D and cancer will have to follow their subjects for at least a decade or two in order to accurately gauge the relationship between intake of the secosteroid and cancer rates. If such studies actually take place, they will almost certainly highlight the drawbacks of vitamin D rather than any purported “benefits”, as the negative consequences of immunosuppression become increasingly apparent over longer periods of time.
Lichtenfeld proceeds to comment on several editorials written in response to the National Cancer Institute study, arguing they “point out that we need to know more about how vitamin D levels change from season to season, and how that impacts our health.”
He also warns readers to heed the following editorial comment, stating that he “couldn’t agree more” with their conclusions:
“Whether vitamin D reduces cancer risks and, if it does, whether these amounts suffice are actively being debated. Randomized clinical trials of the effects of vitamin D on the incidence of colonic polyps and invasive cancer are needed. While vitamin D may well have multiple benefits beyond bone, health professionals and the public should not in a rush to assume, in a rush to judgment, that vitamin D is a magic bullet and consume high amounts of vitamin D. More definitive data on both benefits and potential adverse effects of high doses are urgently needed.”
Indeed, Lichtenfeld seems wise enough to have realized that treatment options that are suspiciously simplistic enough to be dubbed “magic bullets” have seldom if ever held up to medical scrutiny, especially when researchers start to examine the substance at the molecular level.
“When the studies were actually done, we discovered that the vitamins had either no effect or, for some people, may have actually increased their risk of cancer.”“We have consistently called for more research into this topic [vitamin D],” he argues. This is especially important given our past experience with other vitamins, such as vitamin C and beta-carotene, where well-qualified experts touted the benefit of those vitamins in reducing cancer risk. When the studies were actually done, we discovered that the vitamins had either no effect or, for some people, may have actually increased their risk of cancer.”
As with any other blog, readers are able to write responses to Dr. Lichtenfeld’s pieces. The very first person to respond to “Maybe Vitamin D isn’t the Answer After All” was none other then Dr. Jacob Cannell – head of the “Vitamin D Council” – an organization that seeks to promote the consumption of vitamin D, and when I say promote I mean promote. Although the group presents itself as a scientific body, even a quick glance at their website assures the reader that the members of this Council have failed to read, evaluate, or even consider any of the alternate hypotheses proposed about vitamin D – hypotheses based on research that clearly show that extra levels of the secosteroid are harming rather than helping people with chronic disease.
“Perhaps you could explain what residual confounding is?” writes a livid Dr. Cannell. “If so, your readers might feel you fully understand the study. What was the relative risk of breast cancer? I know the sample size was too small for signifigance [sic] but you might want to say what it was? Is it true that the relative risk of breast cancer was almost four times higher in the group with the lower levels?…..What you are actually doing is defending the American Cancer Society’s decision not to follow the Canadian Cancer Society’s recommendation of 1000 IU per day of vitamin D. Say you are wrong and Canada is right? On whose hands will that blood be?”
Apparently for the Vitamin D Council, this is what passes for professional discourse.
Lichtenfeld kept his cool, responding, “What Dr. Cannell has not said is that similar circumstances in the past–with other vitamins that were thought to be harmless and able to reduce the risk of cancer–showed evidence of harm and/or lack of efficacy when subjected to appropriate study. To say that my opinion is equivalent to having blood on my hands is an ad hominem attack not worthy of consideration. His cause would be better served to advocate on behalf of people who need to be screened for colorectal cancer (which would save thousands of lives, based on solid evidence), and join us in encouraging appropriate review of the data and research to definitively answer the issue at hand.”
Lichtenfeld then ended the discussion with a statement that just about sums up one of the biggest problems to result from the fact that the public is getting their information about vitamin D straight from the mouths of people like Cannell, stating:
““When we succumb to making every medical decision solely on the basis of the strongest advocate’s voice, we run the risk of moving medical practice back into an era similar to that from which we are trying to emerge.”“When we succumb to making every medical decision solely on the basis of the strongest advocate’s voice, we run the risk of moving medical practice back into an era similar to that from which we are trying to emerge. If the review and research studies confirm Dr. Cannell’s position, that will be welcome. But we need to once and for all establish the science-based evidence that will conclusively answer the question one way or the other, rather than relying on advocacy to establish dietary and medical practice recommendations for the world.”
At about the same time that Lichtenfeld was advising the public to wait for more research before popping extra vitamin D supplements, author Steven Strauss was addressing similar issues in an entry published on the CBC News blog. To me, it is a remarkable piece, because it comes from one of the few voices that actually says in the midst of what can only be described as vitamin D hysteria, “Hey, wait a minute.” In his online bio, Strauss expresses admiration for the motto of Austrian writer Karl Kraus – “Say what is.” I think it’s pretty clear that Strauss does just that.
Strauss begins his discussion of vitamin D by describing the pressures put not only on himself, but on the average Canadian citizen to purchase vitamin D. “It’s been cold and remarkably un-sunny in my neck of Canada recently — climatic conditions which I have been repeatedly told in the past year should lead me to start scarfing down vitamin D pills, and do it in amounts which likely exceed Health Canada’s daily recommended dosage,” he writes.
Along with his fellow citizens, he’s also been urged by numerous vitamin D advocates – who might be better characterized as zealots – to ignore the Canadian government’s requirements about vitamin D. These advocates, who include researchers such as Reinhold Vieth, Michael Hollick and Cedric Garland, have encouraged Canadian citizens to “strike out on a vitamin D health path of their own” by taking five times the amount of vitamin D suggested by the government.
“And if I don’t, it is my fault — well ‘my’ as in all the media — if you readers get cancer, multiple sclerosis, flu, autism, depression, diabetes, loose teeth, stroke, heart disease, osteoporosis, fractures and God knows what else,” remarks Strauss.
Strauss’ comment is laced with sarcasm as he is well aware of an editorial published last year in the American Journal of Clinical Nutrition in which 15 of the top vitamin D proponents from around the world scolded journalists for not encouraging the public to consume the high amounts of vitamin D recommended by… themselves.
“Well, one should take this kind of criticism to heart,” remarks Strauss. Indeed, the situation caused Strauss to examine other papers on vitamin D.
Among these papers was a study by researchers at Creighton Univerisity in Nebraska, one of the papers cited by the Canadian government in an effort to rationalize its decision to recommend that people in Canada take much more — upwards of two-and-a-half times today’s recommended 400 International Units — vitamin D on a daily basis.
The study, which looked at the cancer rates of women taking vitamin D, taking calcium without vitamin D, or taking nothing over a four year period reported a 60 per cent decrease in collective cancer rates for the vitamin D takers when they took what was something more than twice the currently recommended dosage.
When Strauss took a better look at the study, he wasn’t pleased with what he discovered. Now, I would like to share with my readers an extended portion of Strauss’s post, in his own words, starting with his discussion of the Creighton study. The following is reproduced from the CBC Canada site. Strauss’s argument is too cogent, too compelling, not to share it.
In light of the CCS recommendation and a possible heart disease side-effect, they concluded their letter saying: “As Canadians, we ask the question — have we just traded one problem for another?”
Sounds reasonable, but their concern was brushed back by paper authors Robert Heaney and Joan Lappe of Creighton, who responded that there is no evidence of heart problems with vitamin D doses up to 10 times what they had given people. They added, “The issue of vitamin D toxicity was exhaustively reviewed in this Journal just a few months ago and Sood and Sood may find some reassurance in that report.”
Given this disagreement I, too, needed reassurance and so I went to the review where I found something very non-reassuring. Heaney and Vieth had co-authored the toxicity study with two employees of the Council For Responsible Nutrition, a Washington D.C.-based lobby group and trade association for ingredient suppliers and manufacturers in the dietary supplement industry — that is to say, the official representatives of the people who would make vitamin D.
“Ultimately what the four wrote looks extremely authoritative, and might well be so, but to my mind this collaboration represents not an apparent conflict of interest, but a genuine conflict of interest.”And their roles were anything but minor. One applied “risk assessment methodology” to the results and the other “searched literature and summarized relevant findings.” Ultimately what the four wrote looks extremely authoritative, and might well be so, but to my mind this collaboration represents not an apparent conflict of interest, but a genuine conflict of interest.
And let me explain it with a simple equation. Let us assume that one-third of the people in North America decide, based on the CCS recommendation, to more than double their vitamin D dosage and this costs a bare $20 per person a year. That translates into an extra $2 billion going to vitamin D manufacturers and sellers.
All of this made me go back to the original Creighton paper and look to see if there was any indication of specific conflicts of interest among the researchers in it. The paper says no, with resounding vehemence: “None of the authors was affiliated in any way with an entity involved in the manufacture or marketing of vitamin D.”
Then it goes on to mention that one author, Robert Recker, was on the scientific advisory boards of Roche and Proctor & Gamble, and Heaney was on the scientific advisory board for the International Dairy Food Association and the speaker’s bureau for P & G.
It’s true that Roche doesn’t make vitamins today — but it sold the business in 2003, a time that the Creighton experiment was ongoing. The sale, by the way, was announced at the same time Roche said it had resolved lawsuits growing out of its involvement in vitamin price fixing.
But Proctor remains in the business, in that it has licensed its Olay name to another company to produce Olay vitamins, which include vitamin D in a multivitamin supplement. Not to mention the fact that Heaney reported in 2006 that he had a “financial relationship with SmithKlineGlaxo” — a company which directly produces vitamin D.
And oh, yes, it seems almost everyone doing vitamin D research — Vieth included — gets money from dairy farmers associations in either Canada or the U.S.
So I sent Recker and Heaney an e-mail asking for an explanation and Recker responded: “Neither Dr. Heaney nor I have any affiliation with the company that supplied the vitamin D for the study. We have not had affiliation with the vitamin D work for the companies you mention. I have been a scientific adviser to Roche, P & G and Smith-Kline-Glaxo, but not in their vitamin D work.”
Interestingly finely parsed, but when I Google “Recker and Glaxo” I find him quoted in a company press release endorsing an osteoporosis website the company supports — a site that advocates taking vitamin D and which points out that if you have problems getting it naturally, you can buy supplements that will fill in the gap.
Recker responded in his e-mail to me that, “I do not include the statement in the press release as a potential conflict of interest since I was not making the statement out of any affiliation with GSK. I have not participated in any of the studies nor in any advisory capacity to GSK regarding any vitamin D product. There is often some confusion about what constitutes a potential conflict of interest, as might be the case here. My institution does not require that I list this as a potential conflict of interest in its management of faculty relations with industry.”
Parsing a parse, if you ask me.
I then had a lengthy discussion with Vieth who quite candidly said he had been delighted to join up with the manufacturers’ association employees in the toxicity review paper because he had long admired them for being good scientists. “I was honoured when they asked,” he told me.
As to money conflicts he doesn’t think that was a big issue because vitamin D is a generic product and can be made for very little. He said the pure form of the substance costs about $3,000 a kilogram to make, a figure that translates into the dose each of the women in Nebraska took to ward off cancer costing about 3.5 cents a year to make.
Then he told me he had been angered when his name had been taken off some scientific papers after he, in complete openness, told agencies and journals that he and his wife have set up a vitamin D company in Toronto called Ddrops Inc. She is now the company’s president and it sells a year’s supply of 1,000 IU liquid vitamin D for about $20. “I was told my name was being taken off papers because of my wife’s occupation. That is something I find infuriating and upsetting,” he said.
A little additional research found that Elaine Vieth has told the Hamilton Spectator that pharmacies initially had little interest in selling her product, which can be sprinkled on food or in drinks, but that after the Creighton cancer study appeared she sold 30,000 bottles within two days.
“I am not often struck speechless by life’s contradictions, but here I am.”Who would have thought that the research pertaining to what Ddrops markets as “the sunshine vitamin in just one drop” could be so conflicted?
Nonetheless, let me be absolutely clear. I cannot say that any of the findings of any of the researchers I cite — particularly when it comes to vitamin D’s cancer preventative effects — are erroneous because of the scientists’ commercial connections. Vitamin D may indeed turn out to be the next best thing since free e-mail and ballpoint pens, but I will say that a careful journalist, a prudent journalist, a wise journalist would look at this tangled mess of conflicted interests and results and proceed exceedingly carefully in promoting a massive change in vitamin D dosage levels.
I will say that Health Canada should not be stampeded into doing anything reflexive when it comes to raising vitamin D dosage levels.
And I might also suggest that if university scientists are looking for a less conspiratorial explanation for their perception that media has been loath to join a crusade to raise the dosage levels, they would do well to consider how it looks to outside observers when researchers blithely associate with those who benefit financially from these changes.
And that advice is good on both the sunniest and the cloudiest of days.
In Strauss’ case, an inflamed Vieth wrote back in response to the piece, arguing that. “Is there any conceivable way that a new discovery in nutrition, health or therapeutics could make a difference to the public without involving a commercial interest? Compared to the private sector, government agencies usually move at a snail’s pace. If vitamin D is the example being discussed, then it is foolish to imagine that government will reflect anything newer than what was known ten years ago. Government does not make products for consumers. There can be no progress without the private sector.”
I beg to differ. Mixing commercialism with science is a dangerous endeavor, one that is sure to mislead the public with biased opinions and deliberately cheerful results. It’s the attitude Vieth describes above that has taken the public to the place they are now. They are a group sadly misled by a handful of researchers who zealously advocate for their preconceived beliefs, while refusing to acknowledge even the most valid of scientific research if it proves them wrong.
Amy Proal graduated from Georgetown University in 2005 with a degree in biology. While at Georgetown, she wrote her senior thesis on Chronic Fatigue Syndrome and the Marshall Protocol.