The Institute of Medicine’s Nov. 30 consensus statement claiming most Americans do not need supplemental vitamin D, and that the vitamin has few benefits beyond bone health, has some folks wondering if committee members had preexisting biases or vested interests against supplementation.
It turns out that at least two members of the committee hold patents on synthetic vitamin D analogs used as prescription drugs, or have significant relationships with companies involved in vitamin D drug development.
Glenville Jones, PhD, Head of Biochemistry at Queen’s University, Kingston, ON, and an outspoken member of IOM’s Vitamin D & Calcium review committee, is on the scientific advisory board of Cytochroma, a Canadian specialty pharma company dedicated to “Promoting Health Through Vitamin D Therapeutics."
The company is developing three synthetic vitamin D analogs as prescription drugs initially for the treatment of vitamin D insufficiency and hyperparathyroidism associated with chronic kidney disease. Dr. Jones is named among the “inventors” on several of Cytochroma’s patents.
Cytochroma posted the following in a recent press release: “Cytochroma’s clinical and non-clinical teams continue to achieve important research advances that validate our focus on vitamin D, CYP24 and secondary hyperparathyroidism,” stated P. Martin Petkovich, Chief Scientific Officer. “With existing vitamin D treatments limited by mediocre efficacy and dose-limiting side effects, our therapeutic approach of using vitamin D, yet mitigating the impact of CYP24, may result in superior treatment of secondary hyperparathyroidism in chronic kidney disease patients.”
The company presented three studies of its vitamin D receptor modulating drugs at the recent annual meeting of the American Society of Nephrology.
"Tech Transfers"= Big Dollars
Another member of IOM’s vitamin D review team, Dr. Hector DeLuca, Professor of Biochemistry at the University of Wisconsin, Madison, holds a large number of patents on synthetic vitamin D analogs.
Dr. DeLuca is one of the most respected vitamin D researchers in the country. In the 1960s, he and his colleagues were first to recognize that vitamin D itself has no biological activity, but must be transformed sequentially in the liver and kidneys into bioactive forms. His work also led to discovery of vitamin D receptors in many tissues not previously thought to be targets for this vitamin.
The website for Dr. DeLuca’s lab indicates that his research team is expending, “considerable effort dedicated to collaboration with the medical world for the application of the newly synthesized analogs of the vitamin D compounds and of vitamin A compounds for the treatment of disease. The most recent application has been to prevent and arrest such autoimmune diseases as multiple sclerosis and rheumatoid arthritis, and as an anti-transplant rejection drug.”
Among the “technology transfers” from Dr. DeLuca’s lab to the pharma sector was a vitamin D analog called paricalcitol, licensed to Abbott and marketed under the brand name, Zemplar, for vitamin D deficiency and parathyroidism in patients with renal failure.
In a 2004 interview with Wisconsin Technology Network (WTN News), Dr. DeLuca estimated that revenue from vitamin D analog patents he licensed to the University of Wisconsin Alumni Research Foundation, are largely responsible for funding construction of UW-Madison’s $35.6 million biochemistry center.
In addition to his position in academia, Dr. DeLuca is president and CEO of Deltanoid Pharmaceuticals, a company developing drugs based on vitamin D analogs for treatment of a host of disorders including osteoporosis, renal diseases, psoriasis, autoimmune diseases and cancer.
Deltanoid has raised significant venture capital, and according to the company’s website, has “two active partnership agreements in place with QuatRx Pharmaceuticals (topical treatment for psoriasis) and Primus Pharmaceutical (non-FDA approved medical foods for bone health).” According to WTN News, Deltanoid was involved in a deal several years ago allowing drug giant, Pfizer, to license, develop and commercialize certain of its vitamin D analogs.
These organizations also contend that the IOM committee solicited but then suppressed commentary on the new vitamin D and calcium recommendations from 14 nationally recognized nutrition experts, including Prof. Robert Heaney at Creighton University, and Dr. Walter Willett at Harvard. The Vitamin D Council and the ANH are calling on the IOM to release these 14 comments under the Freedom of Information Act.
The fact that some committee members have direct ties to drug companies is not proof of bias, nor does it completely invalidate the IOM’s report. In fairness to Drs. Jones and DeLuca, and the IOM committee, neither the Vitamin D Council nor the ANH could be considered disinterested and unbiased observers of the vitamin D issue.
Still, these groups are raising legitimate concerns about conflicts of interest and omission of potentially important, possibly dissenting opinions.
The IOM is an independent not-for-profit institution, a division of the National Academy of Sciences. IOM prides itself on objective, non-biased, evidence-based evaluations of key health care issues. Though it is technically “non-governmental,” it’s positions and recommendations strongly influence federal health policy and regulatory standards. Consequently, it is essential for the Institute to provide clear disclosure of industry influences, vested interests or other sources of bias, and to release all information relevant to any of it’s consensus statements.