In another high profile blow to the credibility of dietary supplements, the Children’s Hospital of Philadelphia has removed all but a few dietary supplements from its formulary, meaning parents of children in the hospital will have to sign a waiver in order to continue to give supplements to their children.
Industry sources were quick to react to the move, calling it misguided and short sighted, and said the policy shift would work to restrict patient choice and is not reflective of the current state of medical thought.
Lack of safety data cited
In a statement, the hospital said the move was taken because “the Food and Drug Administration does not routinely review the manufacturing of dietary supplements, and therefore cannot guarantee their safety and effectiveness.” Also underlying the decision is the influence of Dr Paul Offit, a pediatrician who is the chairman of the hospital’s Therapeutic Standards Committee and author of a number of books including Do You Believe in Magic: The Sense and Nonsense of Alternative Medicine which was published this year. Given Offit’s position at the hospital and his harshly critical view of the industry, none of the sources contacted for reaction for this article were surprised at the hospital’s decision.
The hospital’s statement trotted out familiar charges that dietary supplements are “essentially unregulated.”
“Most people assume that supplements they buy at the health food store or online are strictly monitored or are safe because they are 'all natural'," said Sarah Erush, PharmD, BCPS, Pharmacy Clinical Manager and a member of the standards panel. "But supplements are only subject to FDA review if an adverse event is reported, so there are many for which we have no reliable data.”
"Patients with chronic diseases use dietary supplements more frequently than the general population and are at greater risk for adverse events and interactions. Better monitoring and regulating the way we distribute these products is one more step we can take to make sure that we're providing the best possible medical care for our children," Offit said.
Short sighted decision will restrict communication
"It appears that Dr Offit's extremely misguided biases against a highly regulated industry and years of rigorous research showing the many benefits of dietary supplements has influenced [this decision]," said Loren Israelsen, president of the United Natural Products Alliance. "This short-sighted position, based on a number of inaccuracies regarding regulatory oversight, will deny the hospital's patients access to inexpensive and health-promoting nutritional support. This decision certainly does not represent the leading edge of medical practice.”
Steve Mister, president and CEO of the Council for Responsible Nutrition, said the decision will serve to squelch what would benefit the care of the children in question the most, and that is open communication between doctors and the patient’s family. The hospital’s new policy means that patients will be counseled on the hospital's policy discouraging the use of supplements. The attending nurse or physician will “inform parents or guardians of the potential risks associated with the supplement,” according to the hospital’s statement. Will families that use dietary supplements (according to CRN, 85% of US adults are confident of the safety and effectiveness of dietary supplements and more than 60% are regular users) feel welcome at the hospital under those circumstances?
“I think it’s really unfortunate and it’s a real disservice to the patients,” Mister told NutraIngredients-USA. “It’s important that all modalities of health care talk to each other. There are people are using all these forms and it is important that they be able to talk to their doctors about them.
“You need to have a dialogue with your health care provider. This sort of closes the door on that situation,” he said.
Risk in all treatments
It could be viewed as a bit ironic, too, that a hospital, an institution that weighs benefits and risks as a matter of course, was taking this position. Hospitals perform all kinds of services for patients, many of which pose much graver risks than any that could be associated with supplement use.
“There are all kinds of things that people go to the hospital for: surgeries, out patient procedures, prescription drugs and getting medical devices implanted. None of those come with a certainty of safety. So to say that they are not going to allow the use of supplements because they can’t guarantee their safety and effectiveness? They can’t make that kind of guarantee about anything. It seems to miss the point that these other therapies have risks, too,” Mister said.
Refuting the ‘unregulated’ claim
In a letter to the hospital, the Natural Products Association sought to refute the assertion that supplements are unregulated. Supplements are manufactured under federal Good Manufacturing Practice guidelines, the letter said. It went on to detail other instances of regulatory oversight, including the requirement to use only approved ingredients and the legal strictures against the inclusion of adulterants such as active pharmaceutical ingredients.
“The FDA has been regularly inspecting facilities regarding their GMP compliance, and the rate of these inspections has almost doubled each year for the past few years. Based on the regulations listed above and the number of inspections performed, we would dispute the hospital’s impression that dietary supplements are ‘essentially unregulated’ and aren’t ‘routinely reviewed’ by the FDA,” the letter said.
“We would strongly oppose the barriers you’ve set in place for patients to continue their use of dietary supplements. The benefits of supplementation have been confirmed by decades of solid research and in recommendations from the World Health Organization and the American Heart Association, among others,” the NPA said.