By Paul Goldberg
    The UV Foundation is a cheerful, sunny name. The non-profit has sponsored the research of Michael Holick, a Boston University professor, whose work advocates “sensible sun exposure.”
    Research support from the foundation was acknowledged in Holick’s review article in the July 19, 2007, issue of The New England Journal of Medicine that suggests that a few minutes in the sun or at a tanning salon can help avoid the purported deadly consequences of vitamin D deprivation.
    However, the disclosure didn’t mention that the UV Foundation is an offshoot of the Indoor Tanning Association and that all of its board members also serve as fiduciaries of the parent trade association, which represents the artificial tanning industry.
    The foundation acknowledges that it has given Holick more than $150,000 in research support over three years. Under some circumstances, this might have barred him from publishing a literature review article in NEJM, since the journal’s conflict of interest rules preclude scientists who receive “major” research support from industry from writing reviews and editorials on matters that may affect the sponsors of their research.
    Even before the journal’s official publication date, Martin Weinstock, a dermatologist at Brown University, obtained an embargoed copy and informed the NEJM Editor-in-Chief Jeffrey Drazen about Holick’s connections with the tanning industry.
    “I picked up the phone and called Dr. Drazen and expressed my concerns clearly,” Weinstock said to The Cancer Letter. “He stated he would look into the matter, which he confirmed he would do by email.” However, no action has been taken.
    The question of the true identity of organizations that finance research has become increasingly important in recent weeks, particularly at NEJM, a publication that learned recently that a paper on lung cancer it published in 2006 was supported by a charity funded exclusively with money from the cigarette maker Liggett Group Ltd.
    The charity, called the Foundation for Lung Cancer Early Detection, Prevention & Treatment, figured in a disclosure by a group of NEJM authors, Weill Cornell Medical College researchers Claudia Henschke and David Yankelevitz, but its source of funds was unknown until it was revealed by The Cancer Letter and The New York Times (The Cancer Letter, March 28).
    The NEJM was aware of Holick’s funding, said Karen Pedersen, a spokesman for the journal. “The disclosure published with the Holick article provided readers with the sources of support, as our policy requires,” Pedersen said in an email. “We were aware of the sources of funding for the UV Foundation, and that the information was publicly available on their website.”
    In the most recent restatement of the journal’s conflicts of interest policy, published in an editorial on June 13, 2002, the NEJM editors announced that they would allow publication of review papers and editorials by authors who have some financial interest in companies discussed in such articles. The journal uses the NIH definition of “significant financial interest”—an annual income of $10,000 or more—for authors who consult or hold stock in affected companies.
    However, the rules remained the same for authors who receive research grants from such companies.
    “With respect to research grants, our policy will continue to require that authors of review articles and editorials, through their institutions, not have major research support or a major proportion of their funding from relevant companies,” the editorial states. “We consider interactions that occur within two years before publication date of an article to be pertinent. Information about financial relationships below the de minimis level but relevant to the article will be disclosed in the journal.”
    NEJM spokesman Pedersen said Holick’s funding fell below this level. “Grants from the UV Foundation made up 2 to 3 percent of the research support that Dr. Holick disclosed to us at the time of publication,” she said in an email. “The editors consider that proportion to be well within the guidelines laid out in our editorial.” 
    According to tax papers filed by the UV Foundation, Holick’s institution received $50,000 in 2004, another $50,000 in 2005, and $62,014 in 2006.
    “To me, $50,000 a year is an attractive sum, not de minimis,” said Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania.
    Sheldon Krimsky, professor of Urban & Environmental Policy & Planning at Tufts University and author of the book “Science in the Private Interest” agrees.
    “In my view, having a $50,000 connection to a corporation does not seem de minimis, and certainly meets the standards of the U.S. government, and is also higher than what most universities would consider as de minimis,” Krimsky said. “At the very least, in this case, the NEJM has an obligation to the readers to state what they consider de minimis financial interest, and to assert that in this particular case that interest met the editor’s threshold for accepting Holick’s review.”
    Disclosure requirements don’t usually entail encouraging readers to look behind the facades of funding sources, Caplan said.
    “This case makes it hard to see the funding streams very clearly,” he said. “They are saying that they weren’t bothered, and people can track them down. But that doesn’t seem to be quite consistent with what their conflicts of interest policy was trying to accomplish, and if it is, they haven’t made it clear that they expect the reader to get Google in hand and start trying to look behind the declared funding source to see what might be upstream.”
    Over the years, many business interests, particularly tobacco and nutrition companies, have hidden behind non-profits to funnel money to scientists. However, until the Henschke controversy, the issue of hidden sponsorship of research hasn’t been confronted head-on by top-tier medical journals, ethics experts say.
    “The Henschke story has put it on the radar in a way it hasn’t been before, because all of a sudden it’s getting coverage in places like The New York Times,” said Sheldon Rampton, research director for the Center for Media and Democracy. “The discussion has generally taken the form of saying that funding sources might compromise research. But I don’t think that there has been much realization that sometimes those funding conflicts are part of a deliberate effort to corrupt and shape the debate.”
    Caplan said no new rules are required to look for hidden funding sources: industry money channeled through non-profit groups has always been subject to disclosure.
    “This is a situation where the title of the foundation doesn’t reveal the corporate or political or ideological interest behind the funding, and that’s what the editor needs to be told to make the judgment on relevance,” he said. “The editor is flying blind if I say I receive support from the Milk and Cookies Foundation, not revealing that it represents the asbestos industry.”
   
Well-Known Relationship with Indoor Tanning Groups
    Holick said he had disclosed his relationship with the UV Foundation. “I provided [the editors] with the information,” Holick said. “They had asked me even for the physical address of the UV Foundation. What they requested was whether a significant amount of funding was coming from any one of these organizations. But the amount that I was receiving was about 2 percent of my total budget.”
    Holick said his total research budget is about $3 million a year, which comes from NIH grants, grants from the Dairy Council, and private donations. “I never received a penny from the Indoor Tanning Association or the UV Foundation personally, because I knew that it would be a contentious issue for some,” he said. The Dairy Council and private donations aren’t mentioned in the NEJM disclosure.
    Experts in skin cancer say that Holick’s views and his association with the tanning industry are commonly known and openly acknowledged.
Holick said the paper was the outcome of 10 years of discussions with NEJM editors. According to the NEJM instructions for authors, “review articles are usually solicited by the editors, but we will consider unsolicited material. Please contact the editorial office before writing a review article for the journal.”
    No detective work would have been required to determine that the UV Foundation is, in fact, an arm of the tanning industry, and that it funds Holick’s research.
    According to its website, the foundation “has made a commitment of $150,000 over three years to Boston University, to continue the efforts of Dr. Michael Holick, a Vitamin D expert and author of the intriguing new book, ‘The UV Advantage.’”
    The foundation’s source of funding was reported by a blogger, Len Lichtenfeld, deputy chief medical officer at the American Cancer Society. Lichtenfeld also noted that Holick’s work was cited on the UV Foundation and ITA websites.
    Weinstock, a dermatologist at Brown and chairman of the ACS Skin Cancer Advisory Group, read an embargoed copy of the paper and called Drazen immediately. The conversation was followed by a July 18, 2007, confirmatory e-mail from Drazen, Weinstock said.
    Responding, Weinstock reiterated his concern about undisclosed conflicts and the underlying science in Holick’s paper: “Thank you for your attention to this matter. We are concerned because of… possible direct unmentioned conflicts that may relate to his recommendations that tanning booth exposure (and sun exposure) are recommended for vitamin D purposes, and because the quality of evidence behind those recommendations is so poor.”
    Two years earlier, Weinstock and DeAnn Lazovich, of the University of Minnesota Division of Epidemiology and Community Health, wrote a letter to the editor of the American Journal of Clinical Nutrition to object to the disclosure statement on Holick’s paper.
    The letter stated that Holick and coauthors acknowledged support from the UV Foundation, but “failed to note the close connection between the UV Foundation and the commercial tanning industry.” The paper in question is cited in Holick’s review in the NEJM.
    In a recent editorial responding to the revelation that Henschke’s work had been funded by Liggett, the NEJM editors acknowledged that they hadn’t been looking aggressively at the funding of non-profits. "It has not been our practice to inquire about the specific sources of funding of foundations such as this,” the NEJM editors wrote in an editorial published on-line on April 2. “We and our readers were surprised to learn that the sources of the funding of the charitable foundation was, in fact, a large corporation that could have an interest in the study results.”
    The question of true identity of research funders has been relevant all along, and the source of money dispensed through groups like the UV Foundation should have been disclosed, Krimsky said.  
    “It would seem that the NEJM has a moral responsibility to its readers to disclose what this foundation is and the relationship of the person who wrote the research to the foundation, whether or not the funding that this person gets is exclusively for the research, or whether there are other relationships that this person has with that particular foundation,” Krimsky said.
       
The Question of Balance
    Holick’s review article states that “exposure to sunlight or ultraviolet B radiation from a tanning bed or other ultraviolet B-emitting device is also effective” in correcting malabsorprion of vitamin D.
    Specifically, he suggests a portable Sperti lamp as an alternative to a tanning bed. Also, Holick states that for patients with fat malbasorption, exposure to a tanning bed for half the time required for tanning “is an excellent means for treating and preventing vitamin D deficiency.”
    Also, “this reduces the risk of skin cancers associated with ultraviolet B radiation,” Holick writes.
    The review article was unbalanced, Lichtenfeld wrote on his blog on the day of the paper’s publication. “There is no question that the average person reading this article will come away with the impression that sun exposure and using tanning beds is ‘ok.’ as reported in the prestigious New England Journal of Medicine,” he wrote. “On the other side of the recommendation a cadre of well-qualified experts who feel that this is a very dangerous and inappropriate recommendation. But their views are not represented in the article.”
    The claims made by Holick on the UV Foundation website are even more aggressive. On a video clip, Holick claims that visits to tanning salons can prevent cancer.
    “The message is that moderate sensible exposure to sunlight, or if people wish to go to a tanning salon, but they do it responsibly, the benefits may far outweigh the risks of skin cancer,” Holick says. “With about 1,200 people die a year of squamous and basal cell cancers, probably as much as 150,000 people die a year of prostate, breast and colon cancer that could be related to the lack of exposure to sunlight and adequate vitamin D.”
    According to the website, the foundation’s sponsors include the Indoor Tanning Association, as well as Osram, the maker of tanning lamps, and Future Industries, the maker of tanning beds, booths and lamps.
    All of the foundation’s board members also serve on the board of the ITA. The foundation’s president, Dan Humiston, is also the president of ITA and president of Tanning Bed Ltd., a chain of tanning salons based in West Seneca, NY. John Overstreet, a board member, is the executive director of the ITA. Board member Jim Shepherd is the president of Sperti/KBD of Erlanger, Ky., the manufacturer of sun lamps specifically cited in Holick’s review article, and Jerry Frank is president of Cosmedico Light Inc., of Weymouth, Mass., a maker of lamps and power systems for UV lighting equipment.
    The ITA recently hired Berman & Co., a Washington public relations firm that represents tobacco, food and alcohol industries, to develop what ITA describes as “an innovative and audacious strategy.”
    The campaign has so far produced full-page newspaper advertisements that characterize the link between tanning and melanoma as “hype.”
The NEJM has been reluctant to respond to the Henschke controversy as well.
    The journal’s editors were first informed by The Cancer Letter that Henschke and Yankelevitz hadn’t disclosed patents and royalties in the paper published in the Oct. 26, 2006 issue (The Cancer Letter, Jan. 18).    After investigating the matter, the journal responded that the disclosures were made, but the editors found them not relevant (The Cancer Letter, March 14).
    However, the controversy failed to go away. After the story about Henschke’s tobacco funding received attention from the national news media, the journal responded with a correction, a clarification, and an editorial.
    The journal explained that the correction was warranted because the editors had read a letter in the Journal of the American Medical Association in which Henschke and Yankelevitz admitted receiving royalties on their inventions (The Cancer Letter, April 4).
    Also, the journal may have opened itself to penalties for offering continuing medical education credits to physicians who read the lung cancer screening. If the editors’ had indeed deemed Henschke’s and Yankelevitz’s patents not relevant, they have likely violated CME rules that bar physicians who have unmanaged conflicts of interest from offering lectures and article (The Cancer Letter, March 14).

JAMA Corrects the Correction   
    JAMA has published a second version of a correction to a paper and a letter to the editor by Claudia Henschke and David Yankelevitz, the leaders of the International Early Lung Cancer Action Program. The correction appears in the April 16 issue of the journal.
    The first version, published online on March 24, contained a list of patents that list Henschke and Yankelevitz as inventors. However, the document didn’t list multiple sources of research support and was inconsistent with a disclosure provided to the journals published by the American Cancer Society (The Cancer Letter, April 4).
    JAMA’s corrected correction notes that the Foundation for Lung Cancer Early Detection, Prevention and Treatment was established with money from Vector Group, the parent company of Liggett Tobacco.
Henschke served as the foundation’s president and Yankelevitz as its secretary and treasurer.
(Copyright 2008, The Cancer Letter Inc. All rights reserved.)