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STEPHEN STRAUSS: SCIENCE FRICTION

The vitamin D debate

Feb. 13, 2008

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.

And even more importantly, I've been told I should also counsel you to ignore the existing suggestions and strike out on a vitamin D health path of your own, one which might see you taking up to five times today’s suggested dose. (That’s what one advocate announces he is doing).

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.

I know that, because last year 15 scientists from around the world scolded journalists in an American Journal of Clinical Nutrition editorial for effectively condoning ill health.

"We do not think that the public media present the vitamin D story in a complete and accurate manner," they said.

"Reports about vitamin D inadequacies are presented straightforwardly, but when it comes to discussing the intake of vitamin D needed to correct the situation, outdated official recommendations for vitamin D are propagated by the public media. This probably occurs because of restrictive editorial policies driven by concern about possible litigation if media were to advise a 'toxic' intake greater than the [present upper intake level]," they — including Reinhold Vieth of the University of Toronto — wrote.

Well, one should take this kind of criticism to heart. I have, in the last little while, specifically been looking at a paper that came out last year in the AJCN. I did this because it made many people’s top 10 science stories of 2007 and because the finding was described in various Canadian media as strongly influencing the Canadian Cancer Society’s decision to recommend that people in this country take much more — upwards of two-and-a-half times today’s recommended 400 International Units — vitamin D on a daily basis.

The study compared over a lengthy period — four years — the cancer rates in women taking vitamin D, taking calcium without vitamin D, or taking nothing. Researchers at Creighton University in Nebraska then 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.

While the cancer numbers were small — only 50 cases in total — the CCS decision meant there was lots of coverage of the research. I found upwards of 50 reports in magazines, newspapers, radio and television, but absolutely zero coverage of the criticism of the paper that appeared in the journal in recent months.

In one letter, three scientists in Texas pointed out a number of issues, not the least of which being an Iowa study which suggested that when breast cancer was looked at there was indeed a fall in cancer numbers for the first five years when a vitamin D supplement was taken. But this balanced out at 10 years and there actually seemed to be more breast cancers among women taking vitamin D after 15 years.

It is precisely these sorts of yes/no/maybe results that make science and medical writers very, very, very, very cautious about blithely recommending dose rate increases.

Then there were the questions raised by Manish Sood of the Toronto General Hospital and Amy Sood of the University of Toronto faculty of pharmacy. They pointed out that some had suggested the incidence heart disease might grow as a result of increasing the vitamin D dosages and recommending, as the CCS did, that supplements be taken year round or during fall and winter months depending on skin colour and other factors.

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.

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.

Related link:

Take vitamin D to reduce cancer risk, Canadian Cancer Society advises

External links:

American Journal of Clinical Nutrition editorial on vitamin D recommendations

American Journal of Clinical Nutrition article on vitamin D toxicity

Creighton University backgrounder on cancer/vitamin D

(Note: CBC does not endorse and is not responsible for the content of external sites - links will open in new window)

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ABOUT THIS AUTHOR

Biography

Stephen Strauss

Stephen Strauss wrote articles, columns and editorials about science and technology for the Globe and Mail for more than 20 years. He has also authored three books, several book chapters, and for his efforts received numerous awards. Through all his time in journalism, he still remains smitten by the enduring wisdom of the motto of Austrian writer Karl Kraus. Say what is.


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“What I am understanding is how much more complicated the notion of conflict of interest is than I naively had first thought.” Mr Strauss wrote this to me shortly after a telephone interview early in January. I expected him to write a balanced article. But he stuck with the “naïve” point of view he had before he even started researching the topic.

If you, as a reader, want to understand why I, an academic researcher, might connect with commercial interests, then consider the following questions.

1. 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.

2. If a company wanted to incorporate new research or new ideas into its products, is it not appropriate for that company to consult with front-line experts to help ensure things are done right? Why then does Mr Strauss demean academic experts who are open enough to disclose relationships when they publish? Is that really “investigative journalism”?

3. If you were an academic researcher passionate about your work, would you not want to use every possible approach to help your science provide a benefit for society, even if that includes giving advice to a company that asks you for help?

In my case, there is an unusual fourth question

:

4. If a family member were to take up an interest in your passion, would you stop him or her for fear of what someone like Stephen Strauss might criticize it?

Regardless of what Mr Strauss suggests I should be doing, I will continue to “blithely associate” with my wife. I am very proud of her success at having introduced liquid vitamin D supplements that we honestly do think will help Canadians, spanning from those who are breastfeeding to those in senior-citizens homes. To understand what motivates us, please do look at the following link to see what mothers say about Baby Ddrops. http://forum.canadianparents.com/ubbthreads/ubbthreads.php?ubb=showflat&Number=690410

Without the combined efforts of my wife, and of me as a scientific consultant, the product would not exist. If a fear of the naive musings of Mr Strauss ruled the commercial relations of academic scientists, then it is certain that innovation would suffer. We would need to rely more on government to provide health products, because only from government would those products come without financial strings attached.

Mr Strauss suggests that as a journalist, he felt slighted by comments that my coauthors and I have published about the media. We wrote that media reports too often end up confusing the public about vitamin D. I stand behind that critique, and The Vitamin D Debate by Mr Strauss is a prime example of media misinformation.

He focuses on a letter to the editor, by Sood and Sood who claimed that cardiovascular disease is something people should be worrying about if they take vitamin D. I highly doubt that Mr Strauss checked into the background and credibility of those authors who disparaged the use of vitamin D. Mr Strauss ignored the steady flow of research showing that more vitamin D seems to be protective against cardiovascular disease.

Mr Strauss ignored the good stories about vitamin D, and was drawn like a media moth to the inflammatory negative things that people seem to enjoy reading.

What else should anybody expect from a column called, “Science Friction”.

– Reinhold Vieth | Ont.

An excellent article on the convoluted background to what we assume are unbiased "scientific studies". But it is also an indictment against what has happened in universities over the last 20 years with more and more studies and research grants being given based on their economic value rather than intrinsic research value.

There are very, very few totally unbiased studies these days and this is the greater, overall concern that gets almost no media coverage!

– Terry McDonald | Guelph, ON

I commend you for your due diligence prior to jumping onto the supplements bandwagon.

Sadly, I think the vast majority of medical and nutritional research is hopelessly mired by industry sponsorship. The vitamin D issue is one page in a very large tome.

As long as the heavily interested makers of "Wondercillin" are sponsoring the scientific research, it is no surprise that Wondercillin will look terrific in published research.

Inevitably, "Expert Groups" sponsored by industry, and paid very handsome honoraria, will publish "Consensus Guidelines" proclaiming that Wondercillin is underused because its target condition, Whateverailsya, is woefully under-recognized and under-treated by physicians. Industry will also helpfully create Web-sites, glossy brochures, and TV ad campaigns to raise awareness. The travelling roadshow of experts will reach out to physicians, warning them of this dreadful condition and how to detect it: "Are you sure it's just shyness? It could be Social Anxiety Disorder!!!"

This sad pattern repeats itself over and over, and the pace has especially quickened since the 80's, when publicly funded research of disease treatments' efficacy and safety was heavily curtailed across Europe and in North America, leading to the currently ludicrous scenario of industry funding the research, choosing which papers to submit to journals (handily burying studies which show no effect or which actually show harms), and funding the regulatory process to get government approval to sell the medication. The launch of direct-to-consumer advertising since 2000 has been the latest accelerator.

Sadly, in my view, this remains the real under-reported story.

Thank-you very much for not blandly going along with the latest hype and for asking the always crucial question, "Cui bono?" This is journalistic integrity, and it is always a pleasure to encounter.

The medicalization of every day life is upon us, but it can and should be questioned skeptically by all thoughtful persons, especially by science journalists and physicians

.

– Robert Tarzwell | Vancouver

An excellent piece of investigative journalism that highlights the dangers of mixing science, commerce and public policy. Unfortunately the trend of relying more and more on the private sector to fund research makes it very difficult to avoid the appearance of conflict of interest.

We need to return to the previous model where research was publicly funded and carried out independently from the companies that produce the products. Our universities and hospitals should not be used as a marketing tool for pharmaceutical companies.

We don't know if the scientists who conducted the research on vitamin D were influenced by their association with companies that stood to benefit by positive findings. This is not good. Unfortunately the current climate makes it difficult for scientists to pursue their research without the funding these companies provide. This does a disservice both to the scientists, to the public, and to other scientists working in the same field who can no longer fully trust the research results of their colleagues.

– Gary Dale | Toronto

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