Reprinted with permission from the UNPA (United Natural Products Alliance)

This conference summary was prepared by UNPA's Steve Ferraro, providing insights and commentary on the recent NIH Consensus Conference on Multivitamin/Mineral Supplements and Chronic Disease Prevention.

This conference summary was prepared by UNPA's Steve Ferraro, providing insights and commentary on the recent NIH Consensus Conference on Multivitamin/Mineral Supplements and Chronic Disease Prevention.The NIH Consensus Development Program Conference on Multivitamin/Mineral Supplements and Chronic Disease Prevention (May 15-17, 2006) brought together 13 NIH-selected panelists to hear scientific evidence from 19 experts and administrators in related fields to produce a report addressing six questions:

1. What are the current patterns and prevalence of the public’s use of multivitamin/mineral (MVM) supplements?

2. What is known about the dietary nutrient intake of MVM users versus non-users?

3. What is the efficacy of single vitamin/mineral supplement use in chronic disease prevention?

4. What is the efficacy of MVM in chronic disease prevention in the general population of adults?

5. What is known about the safety of MVM for the generally healthy population?

6. What are the major knowledge gaps and research opportunities regarding MVM use?

MVM Use

MVM use is growing at 30% per year, with the highest growth among seniors and generation Y.  MVM usage patterns were unsurprising: the greatest use is among females, non-Hispanic whites, seniors, the more educated, the wealthier, those with a lower BMI, etc.  Notably, MVM use is also higher among those diagnosed with cancer, former smokers, and those living in western states.

Consumers use MVM supplements to promote general health or increase energy; to prevent conditions such as heart disease, hypertension, memory and concentration issues, diabetes, osteoporosis, and frequent colds and flu; and to treat existing conditions including vision problems, high cholesterol, arthritis/joint pain, acid reflux, blood sugar issues, and intestinal irregularity.

It was reported that 69% of the general public believe MVM supplements are effective in disease prevention, while 62% believe MVMs are useful in treating medical conditions.  In 2005, 84% of adults (18 or older) took a vitamin or mineral supplement--compared to 72% who used an over the counter medicine in 2005.

Economic and Health Outcomes

Long-term MVM use (>11 years) was found to be a statistically significant predictor of good health.[1] MVM users as a group engage in health enhancing behaviors (such as regular exercise, balanced diet, not smoking, moderate alcohol consumption, etc.) more frequently than nonusers and individually incur approximately $100 less in annual heath care costs.  In aggregate, MVM users who also engage in health enhancing behaviors realize an annual savings of $8.0 billion in reduced health care costs.

Prevention

The panel concluded that there was insufficient data to answer questions of efficacy and safety, and therefore could not recommend either for or against vitamin/mineral supplementation for the prevention of chronic disease in the general American population.  The panel was instructed to consider only results from randomly controlled trials (RCT).  Since much of the current knowledge of MVM safety and efficacy is from observational studies, case studies and cohort studies, the panel recommended that the research community conduct more RCTs on MVM safety and efficacy in disease prevention.

Safety

The question about MVM supplement safety generated the most controversy and was taken as an invitation by a few speakers and panelists to offer critiques of current regulatory policy as well as their personal recommendations for policy changes.  Among the most critical were speakers Elizabeth Yetley, Ph.D. and Irwin Rosenberg, M.D., who were the first and last speakers respectively, and panelists Douglas Rodgers, M.D., and William Vaughan of Consumers’ Union.  Many of these suggestions found their way into the panel’s draft report essentially unchanged.

The topics of adverse event reporting (AER), good manufacturing practices (GMP), labeling requirements, revisions to DSHEA, the use of supplements as ‘drugs’ to treat disease, and increasing FDA’s authority over the industry were all raised throughout the conference and/or in the draft report.  In all, there was remarkably complete coverage of regulatory issues for an event billed as a State-of-the-Science Conference.

Despite their willingness to suggest changes the panel in general betrayed little comprehensive understanding of the regulatory framework (two panelists, Audrey Saftlas, Ph.D. and Diane Birt, Ph.D. openly acknowledged this).  The panel deferred to the 2005 Institute of Medicine (IOM) report Dietary Supplements: A Framework for Evaluating Safety as a primary source of insight on regulatory policy and recommendations, but nevertheless claimed their report would be the fourth report in recent years (the other two coming from a White House conference on alternative medicine and a New York committee on ethics in medicine) to make such recommendations—a dubious claim indeed if the recommendations and their rationale were mere adaptations of those in the IOM report.  Many panelists’ support for regulatory changes (including Drs. Saftlas and Birt) however, did seem well-intentioned and grounded in the scientific goal of generating more useful data.

During the safety-related question-and-answer period several industry representatives spoke out against the panel’s regulatory recommendations:

• Steve Mister, Esq. of the Council for Responsible Nutrition (CRN) expressed concern that suggestions for changes to the statutory and regulatory framework lay outside the scope of the six questions the panel was charged with answering, saying, “I can assure you had questions about policy changes been posited to the public prior to this event you would certainly have received some very thoughtful and well-considered views about whether there ought to be changes to DSHEA or the statutory framework around these products.”

Mister noted that CRN supports mandatory AER, final publication of GMP regulations, increased FDA enforcement activity, and increased public education (all of which were recommended by the panel) but added that none of these things require a change to the statutory framework.  He pointed out that former FDA Commissioners McClellan and Crawford had both told Congress that they believe there is ample authority in the statute to protect consumers.

This comment was met with the following retort from panelist Douglas Rodgers, M.D.:

“Whether there are some officials within the FDA who feel that they have enough regulatory power to police your industry is totally irrelevant because it’s what our panel feels they need, not what some individual within the FDA feels he needs.  They serve us.  We don’t serve them.”

• Dr. Steven Dentali of the American Herbal Products Association (AHPA) also expressed concern with the panel’s attention to regulatory issues, and in particular its reliance on the 2005 IOM regulatory framework for dietary supplements report.  He commented that, as a reviewer for 2005 IOM report, he considers that report to inadequate as a regulatory tutorial and cautioned, “There is a critical need to understand the specifics of an issue before you make public surveys and public comment on it, that’s my concern.”

Dentali said that AHPA supports AER and the labeling of OTC drugs (which was mentioned by the panel) to ‘level the playing field’, and called for improved communications among industry regulators, IOM and other organizations that set standards such as US Pharmacopoeia.

• Dr. Richard Cotter of Wyeth Consumer Health Care pointed out that a significant portion of the panel’s concerns would be addressed by GMP regulations, adding that GMP regulation has been “a major concern of our industry for over ten years” and that a GMP draft that was submitted in 1997 has been stuck in a ‘Nirvana-land’ between the Office of Management and Budget and FDA for some three or four years now.  He commented bluntly, “I would say that we do not have an engaged partner in the government in this endeavor.”
  
• Michael Morton of Vitamin Relief took issue with the assertion in the draft report that the FDA has insufficient legislative authority:

“I’d also like to go on record as stating in the last six years, I’ve been in numerous meetings where FDA officials had made it clear that they did have sufficient legislative and regulatory authority.  What they said they needed [was] increased funding to be able to enforce that authority,” adding,

“[FDA] are not asking for more legislation.  They’re asking for funds to be able to implement what they already have the power to do and to enforce it”

• John Hathcock of the Council for Responsible Nutrition contributed some historical perspective on the continual clamor for increased regulatory authority, noting that in the 70s the ‘unapproved drug theory’ led to the Proxmire Amendment, in the 90s the ‘unapproved food additive theory’ led to one of the major elements for the passage of DSHEA, and that these, like the current call for greater regulatory authority, were variants on a premarket approval theme.  Hathcock concluded by warning, “I would call your attention to the Rx drug examples if you think that premarket approval is the answer to the safety issue.”

The exchanges above can be viewed online at consensus.nih.gov on the webcast of day 3, beginning at 1 hour, 9 minutes

Unfortunately, during the course of the conference the dietary supplement industry was often characterized as ‘unregulated’ or ‘virtually unregulated’, with intimations that this makes supplements potentially dangerous.

To gauge the main messages reaching the public following this conference, UNPA is conducting an informal survey of media headlines related to the conference.  In the days immediately following the conference, stories questioning MVM supplement effectiveness in disease prevention or simply reporting that there are insufficient data greatly outweighed stories relating to safety or industry regulation.

Watch for a follow-up report on the evolution of the media message in the upcoming weeks.

Addendum

Highlights from the draft report relating to regulation:

The ending words of the introduction:

"Because of the need for more reliable information on MVMs, we have made strong recommendations for research and increased U.S. FDA oversight of the MVM industry."

Included in the response to "What is known about the safety of MVM for the generally healthy population?”

(In the context of safety data from RCTs):  "Issues that have not been adequately addressed include but are not limited to: 1. reproducibility of the MVM manufacturing process, 2. independent validation of the characterization of the vitamin mix, 3. demonstration of the absence of contaminants, 4. stability, and 5. interactions with other nutrients and/or drugs"

"We found the primary recommendation of the 2005 IOM committee report on dietary supplements compelling: '...the regulatory mechanisms for monitoring the safety of dietary supplements, currently defined by DSHEA, [should] be revised.  The constraints imposed on FDA with regard to ensuring the absence of unreasonable risk associated with the use of dietary supplements make it difficult for the health of the American public to be adequately protected.'... We recommend Congress revise and update the law to reflect current knowledge."

Contained in the conclusion:

"The current level of public assurance of the safety and quality of MVMs is inadequate, given the fact that manufacturers of these products are not required to report adverse events, and FDA has no regulatory authority to require labeling changes or to help inform the public of these issues and concerns.  It is important that FDA's pervue over these products be authorized and implemented."

The panel’s draft report can be downloaded from:

http://www.consensus.nih.gov/2006/MVMDRAFT051706.pdf

The conference’s program and abstracts, which includes a list of speakers and panelists, and a webcast of the conference can be found at at:

http://www.consensus.nih.gov