NIH STATE-OF-THE-SCIENCE PANEL URGES MORE INFORMED APPROACH TO MULTIVITAMIN/MINERAL USE FOR CHRONIC DISEASE PREVENTION

[Guest guest]

U.S. Department of Health and Human Services

NATIONAL INSTITUTES OF HEALTH

NIH News

NIH Office of the Director (OD)

http://www.nih.gov/icd/od/

Office of Medical Applications of Research (OMAR)

http://odp.od.nih.gov/omar/

FOR IMMEDIATE RELEASE: Wednesday, May 17, 2006

CONTACT: Kelli Marciel (OMAR), marcielk@..., 301-496-4819

NIH STATE-OF-THE-SCIENCE PANEL URGES MORE INFORMED APPROACH TO

MULTIVITAMIN/MINERAL USE FOR CHRONIC DISEASE PREVENTION

PANEL CALLS FOR EXPANDED OVERSIGHT OF VITAMIN AND MINERAL SUPPLEMENTS

An independent panel convened this week by the NIH Office of Medical

Applications of Research and the Office of Dietary Supplements assessed

the available evidence on the safety and effectiveness of

multivitamin/minerals (MVMs). Following two days of expert

presentations, public discussion, and panel deliberations, the panel

made recommendations regarding certain specific supplements but

ultimately concluded that more rigorous scientific research is needed

before strong recommendations can be made regarding MVM use to prevent

chronic diseases.

The panel released a draft statement of its findings this morning, at

the close of the conference. The panel's findings pertain to the

generally healthy population, and do not include pregnant women,

children, or those with disease. Full text of the panel's draft

state-of-the-science statement will be available late today at

http://consensus.nih.gov. The final version will be available at the

same Web site in four to six weeks.

" Half of American adults are taking MVMs and the bottom line is that we

don't know for sure that they're benefiting from them. In fact, we're

concerned that some people may be getting too much of certain

nutrients, " said J. McGinnis, M.D., M.P.P., Senior Scholar with

the Institute of Medicine of the National Academy of Sciences, who

chaired the panel.

The panel recommended the combined use of calcium and vitamin D

supplementation for postmenopausal women to protect bone health. The

panel also advocated that anti-oxidants and zinc be considered for use

by non-smoking adults with early-stage, age-related macular

degeneration, an eye condition that can cause blindness. The panel

supports previous recommendations by the CDC that women of childbearing

age take daily folate to prevent neural tube defects (birth defects of

the brain and spinal cord) in infants. Conversely, it found no evidence

to recommend beta carotene supplements, a form of vitamin A, for the

general population, and strong evidence to caution smokers against

taking them. Specifically, beta-carotene was linked to an increase in

lung cancer among smokers who took the vitamin regularly.

In looking specifically at MVMs for chronic disease prevention, however,

the panel found that the available data are insufficient to make a firm

recommendation for or against their use in the general population.

Of note, rates of MVM use are highest among those who engage in other

positive health behaviors such as regular exercise and eating a

healthier diet, making it difficult to determine whether the MVM alone

is truly responsible for any observed improvement in health.

Most of the public assumes that the components of MVM supplements are

safe, because many of the ingredients are found in everyday foods and

the products are available over-the-counter. The panel identified

several possible risks associated with MVM consumption, however. Among

these is the potential for overconsumption of certain nutrients, with

the resulting possibility of adverse effects. Though health-conscious

individuals are likely to be focused on ensuring that they meet the

recommendations for essential nutrients, the combined effects of eating

fortified foods, taking MVMs, and consuming single vitamins or minerals

in large doses, may lead them to unwittingly exceed the Upper Levels

(ULs) of nutrients, which can be harmful.

Given these safety concerns and the limitations of the available

evidence, the panel advocated for changes in the regulation of dietary

supplements -- including MVMs -- by the Food and Drug Administration

(FDA). Specifically, the panel recommends that Congress expand FDA's

authority and resources to require manufacturers to disclose adverse

events, to ensure quality production, and to facilitate consumer

reporting of adverse events by including reporting information on

dietary supplement labels.

The panel also made several specific recommendations regarding future

research, including but not limited to the following:

-- Design and conduct rigorous randomized, controlled trials of the

impact of individual supplements to test their efficacy and safety in

prevention of chronic disease, using well-validated measures

-- Build new MVM databases that detail the exact composition of

supplements, update them on a continuous basis, and assure their

constant availability to the research community

-- Develop a strategy to support a better understanding of possible

interactions between MVMs and prescribed or over-the-counter

medications.

The 13-member panel included experts in the fields of food science and

human nutrition, biostatistics, biochemistry, toxicology, geriatric

medicine, family medicine, pediatrics and pediatric endocrinology,

cancer prevention, epidemiology, disease prevention and health

promotion, and consumer protection. A brief biography on Dr. McGinnis is

available at http://www.iom.edu/?id=28194. A listing of the panel

members and their institutional affiliations is included in the draft

conference statement.

In addition to the material presented at the conference by speakers and

the comments and concerns of conference participants presented during

discussion periods, the panel considered pertinent research from the

published literature and the results of a systematic review of the

literature commissioned by the NIH Office of Medical Applications of

Research (OMAR). The systematic review was prepared through the Agency

for Healthcare Research and Quality (AHRQ) Evidence-based Practice

Center (EPC) program, by the s Hopkins University Evidence-based

Practice Center. The EPCs develop evidence reports and technology

assessments based on rigorous, comprehensive syntheses and analyses of

the scientific literature, emphasizing explicit and detailed

documentation of methods, rationale, and assumptions. The evidence

report on Multivitamin/Mineral Supplements and Prevention of Chronic

Diseases is available at http://www.ahrq.gov/clinic/tp/multivittp.htm.

The panel's statement is an independent report and is not a policy

statement of the NIH or the federal government. The NIH Consensus

Development Program, of which this conference is a part, was established

in 1977 as a mechanism to judge controversial topics in medicine and

public health in an unbiased, impartial manner. NIH has conducted 118

consensus development conferences, and 27 state-of-the-science (formerly

" technology assessment " ) conferences, addressing a wide range of issues.

A backgrounder on the NIH Consensus Development Program process is

available at http://consensus.nih.gov/forthemedia.htm.

Interviews with panel members can be arranged by calling Kelli Marciel

at 301-496-4819 or via e-mail to marcielk@....

PRESS CONFERENCE:

Reporters can view the press conference at 2:00 pm today and submit

questions at http://videocast.nih.gov/ or send questions to

marcielk@... before 2:45 pm.

NOTE TO TV EDITORS:

The press conference will be broadcast live via satellite at the

following coordinates:

C-Band Galaxy 3C

Transponder: 21C

Orbital Location: 95 degrees west

Downlink Frequency: 4120 H

Audio: 6.2/6.8

Test time: 1:30-2:00 p.m. ET

Broadcast: 2:00-3:00 p.m. ET

NOTE TO RADIO EDITORS:

An audio report of the conference results will be available after 5:00

p.m. Wednesday, May 17 from the NIH Radio News Service by calling

1-800-MED-DIAL (1-800-633-3425) or visiting

http://www.nih.gov/news/radio/index.htm.

The Office of the Director, the central office at NIH, is responsible

for setting policy for NIH, which includes 27 Institutes and Centers.

This involves planning, managing, and coordinating the programs and

activities of all NIH components. The Office of the Director also

includes program offices which are responsible for stimulating specific

areas of research throughout NIH. Additional information is available at

http://www.nih.gov/icd/od/.

The National Institutes of Health (NIH) -- " The Nation's Medical

Research Agency " -- includes 27 Institutes and Centers and is a

component of the U.S. Department of Health and Human Services. It is the

primary federal agency for conducting and supporting basic, clinical and

translational medical research, and it investigates the causes,

treatments, and cures for both common and rare diseases. For more

information about NIH and its programs, visit www.nih.gov.

##

This NIH News Release is available online at:

http://www.nih.gov/news/pr/may2006/od-17.htm.

To subscribe (or unsubscribe) from this list, go to

http://list.nih.gov/cgi-bin/wa?SUBED1=nihpress & A=1.

_________________________________________________________________

Don’t just search. Find. Check out the new MSN Search!

http://search.msn.click-url.com/go/onm00200636ave/direct/01/

[Guest guest]

U.S. Department of Health and Human Services

NATIONAL INSTITUTES OF HEALTH

NIH News

NIH Office of the Director (OD)

http://www.nih.gov/icd/od/

Office of Medical Applications of Research (OMAR)

http://odp.od.nih.gov/omar/

FOR IMMEDIATE RELEASE: Wednesday, May 17, 2006

CONTACT: Kelli Marciel (OMAR), marcielk@..., 301-496-4819

NIH STATE-OF-THE-SCIENCE PANEL URGES MORE INFORMED APPROACH TO

MULTIVITAMIN/MINERAL USE FOR CHRONIC DISEASE PREVENTION

PANEL CALLS FOR EXPANDED OVERSIGHT OF VITAMIN AND MINERAL SUPPLEMENTS

An independent panel convened this week by the NIH Office of Medical

Applications of Research and the Office of Dietary Supplements assessed

the available evidence on the safety and effectiveness of

multivitamin/minerals (MVMs). Following two days of expert

presentations, public discussion, and panel deliberations, the panel

made recommendations regarding certain specific supplements but

ultimately concluded that more rigorous scientific research is needed

before strong recommendations can be made regarding MVM use to prevent

chronic diseases.

The panel released a draft statement of its findings this morning, at

the close of the conference. The panel's findings pertain to the

generally healthy population, and do not include pregnant women,

children, or those with disease. Full text of the panel's draft

state-of-the-science statement will be available late today at

http://consensus.nih.gov. The final version will be available at the

same Web site in four to six weeks.

" Half of American adults are taking MVMs and the bottom line is that we

don't know for sure that they're benefiting from them. In fact, we're

concerned that some people may be getting too much of certain

nutrients, " said J. McGinnis, M.D., M.P.P., Senior Scholar with

the Institute of Medicine of the National Academy of Sciences, who

chaired the panel.

The panel recommended the combined use of calcium and vitamin D

supplementation for postmenopausal women to protect bone health. The

panel also advocated that anti-oxidants and zinc be considered for use

by non-smoking adults with early-stage, age-related macular

degeneration, an eye condition that can cause blindness. The panel

supports previous recommendations by the CDC that women of childbearing

age take daily folate to prevent neural tube defects (birth defects of

the brain and spinal cord) in infants. Conversely, it found no evidence

to recommend beta carotene supplements, a form of vitamin A, for the

general population, and strong evidence to caution smokers against

taking them. Specifically, beta-carotene was linked to an increase in

lung cancer among smokers who took the vitamin regularly.

In looking specifically at MVMs for chronic disease prevention, however,

the panel found that the available data are insufficient to make a firm

recommendation for or against their use in the general population.

Of note, rates of MVM use are highest among those who engage in other

positive health behaviors such as regular exercise and eating a

healthier diet, making it difficult to determine whether the MVM alone

is truly responsible for any observed improvement in health.

Most of the public assumes that the components of MVM supplements are

safe, because many of the ingredients are found in everyday foods and

the products are available over-the-counter. The panel identified

several possible risks associated with MVM consumption, however. Among

these is the potential for overconsumption of certain nutrients, with

the resulting possibility of adverse effects. Though health-conscious

individuals are likely to be focused on ensuring that they meet the

recommendations for essential nutrients, the combined effects of eating

fortified foods, taking MVMs, and consuming single vitamins or minerals

in large doses, may lead them to unwittingly exceed the Upper Levels

(ULs) of nutrients, which can be harmful.

Given these safety concerns and the limitations of the available

evidence, the panel advocated for changes in the regulation of dietary

supplements -- including MVMs -- by the Food and Drug Administration

(FDA). Specifically, the panel recommends that Congress expand FDA's

authority and resources to require manufacturers to disclose adverse

events, to ensure quality production, and to facilitate consumer

reporting of adverse events by including reporting information on

dietary supplement labels.

The panel also made several specific recommendations regarding future

research, including but not limited to the following:

-- Design and conduct rigorous randomized, controlled trials of the

impact of individual supplements to test their efficacy and safety in

prevention of chronic disease, using well-validated measures

-- Build new MVM databases that detail the exact composition of

supplements, update them on a continuous basis, and assure their

constant availability to the research community

-- Develop a strategy to support a better understanding of possible

interactions between MVMs and prescribed or over-the-counter

medications.

The 13-member panel included experts in the fields of food science and

human nutrition, biostatistics, biochemistry, toxicology, geriatric

medicine, family medicine, pediatrics and pediatric endocrinology,

cancer prevention, epidemiology, disease prevention and health

promotion, and consumer protection. A brief biography on Dr. McGinnis is

available at http://www.iom.edu/?id=28194. A listing of the panel

members and their institutional affiliations is included in the draft

conference statement.

In addition to the material presented at the conference by speakers and

the comments and concerns of conference participants presented during

discussion periods, the panel considered pertinent research from the

published literature and the results of a systematic review of the

literature commissioned by the NIH Office of Medical Applications of

Research (OMAR). The systematic review was prepared through the Agency

for Healthcare Research and Quality (AHRQ) Evidence-based Practice

Center (EPC) program, by the s Hopkins University Evidence-based

Practice Center. The EPCs develop evidence reports and technology

assessments based on rigorous, comprehensive syntheses and analyses of

the scientific literature, emphasizing explicit and detailed

documentation of methods, rationale, and assumptions. The evidence

report on Multivitamin/Mineral Supplements and Prevention of Chronic

Diseases is available at http://www.ahrq.gov/clinic/tp/multivittp.htm.

The panel's statement is an independent report and is not a policy

statement of the NIH or the federal government. The NIH Consensus

Development Program, of which this conference is a part, was established

in 1977 as a mechanism to judge controversial topics in medicine and

public health in an unbiased, impartial manner. NIH has conducted 118

consensus development conferences, and 27 state-of-the-science (formerly

" technology assessment " ) conferences, addressing a wide range of issues.

A backgrounder on the NIH Consensus Development Program process is

available at http://consensus.nih.gov/forthemedia.htm.

Interviews with panel members can be arranged by calling Kelli Marciel

at 301-496-4819 or via e-mail to marcielk@....

PRESS CONFERENCE:

Reporters can view the press conference at 2:00 pm today and submit

questions at http://videocast.nih.gov/ or send questions to

marcielk@... before 2:45 pm.

NOTE TO TV EDITORS:

The press conference will be broadcast live via satellite at the

following coordinates:

C-Band Galaxy 3C

Transponder: 21C

Orbital Location: 95 degrees west

Downlink Frequency: 4120 H

Audio: 6.2/6.8

Test time: 1:30-2:00 p.m. ET

Broadcast: 2:00-3:00 p.m. ET

NOTE TO RADIO EDITORS:

An audio report of the conference results will be available after 5:00

p.m. Wednesday, May 17 from the NIH Radio News Service by calling

1-800-MED-DIAL (1-800-633-3425) or visiting

http://www.nih.gov/news/radio/index.htm.

The Office of the Director, the central office at NIH, is responsible

for setting policy for NIH, which includes 27 Institutes and Centers.

This involves planning, managing, and coordinating the programs and

activities of all NIH components. The Office of the Director also

includes program offices which are responsible for stimulating specific

areas of research throughout NIH. Additional information is available at

http://www.nih.gov/icd/od/.

The National Institutes of Health (NIH) -- " The Nation's Medical

Research Agency " -- includes 27 Institutes and Centers and is a

component of the U.S. Department of Health and Human Services. It is the

primary federal agency for conducting and supporting basic, clinical and

translational medical research, and it investigates the causes,

treatments, and cures for both common and rare diseases. For more

information about NIH and its programs, visit www.nih.gov.

##

This NIH News Release is available online at:

http://www.nih.gov/news/pr/may2006/od-17.htm.

To subscribe (or unsubscribe) from this list, go to

http://list.nih.gov/cgi-bin/wa?SUBED1=nihpress & A=1.

_________________________________________________________________

Don’t just search. Find. Check out the new MSN Search!

http://search.msn.click-url.com/go/onm00200636ave/direct/01/

[Guest guest]

U.S. Department of Health and Human Services

NATIONAL INSTITUTES OF HEALTH

NIH News

NIH Office of the Director (OD)

http://www.nih.gov/icd/od/

Office of Medical Applications of Research (OMAR)

http://odp.od.nih.gov/omar/

FOR IMMEDIATE RELEASE: Wednesday, May 17, 2006

CONTACT: Kelli Marciel (OMAR), marcielk@..., 301-496-4819

NIH STATE-OF-THE-SCIENCE PANEL URGES MORE INFORMED APPROACH TO

MULTIVITAMIN/MINERAL USE FOR CHRONIC DISEASE PREVENTION

PANEL CALLS FOR EXPANDED OVERSIGHT OF VITAMIN AND MINERAL SUPPLEMENTS

An independent panel convened this week by the NIH Office of Medical

Applications of Research and the Office of Dietary Supplements assessed

the available evidence on the safety and effectiveness of

multivitamin/minerals (MVMs). Following two days of expert

presentations, public discussion, and panel deliberations, the panel

made recommendations regarding certain specific supplements but

ultimately concluded that more rigorous scientific research is needed

before strong recommendations can be made regarding MVM use to prevent

chronic diseases.

The panel released a draft statement of its findings this morning, at

the close of the conference. The panel's findings pertain to the

generally healthy population, and do not include pregnant women,

children, or those with disease. Full text of the panel's draft

state-of-the-science statement will be available late today at

http://consensus.nih.gov. The final version will be available at the

same Web site in four to six weeks.

" Half of American adults are taking MVMs and the bottom line is that we

don't know for sure that they're benefiting from them. In fact, we're

concerned that some people may be getting too much of certain

nutrients, " said J. McGinnis, M.D., M.P.P., Senior Scholar with

the Institute of Medicine of the National Academy of Sciences, who

chaired the panel.

The panel recommended the combined use of calcium and vitamin D

supplementation for postmenopausal women to protect bone health. The

panel also advocated that anti-oxidants and zinc be considered for use

by non-smoking adults with early-stage, age-related macular

degeneration, an eye condition that can cause blindness. The panel

supports previous recommendations by the CDC that women of childbearing

age take daily folate to prevent neural tube defects (birth defects of

the brain and spinal cord) in infants. Conversely, it found no evidence

to recommend beta carotene supplements, a form of vitamin A, for the

general population, and strong evidence to caution smokers against

taking them. Specifically, beta-carotene was linked to an increase in

lung cancer among smokers who took the vitamin regularly.

In looking specifically at MVMs for chronic disease prevention, however,

the panel found that the available data are insufficient to make a firm

recommendation for or against their use in the general population.

Of note, rates of MVM use are highest among those who engage in other

positive health behaviors such as regular exercise and eating a

healthier diet, making it difficult to determine whether the MVM alone

is truly responsible for any observed improvement in health.

Most of the public assumes that the components of MVM supplements are

safe, because many of the ingredients are found in everyday foods and

the products are available over-the-counter. The panel identified

several possible risks associated with MVM consumption, however. Among

these is the potential for overconsumption of certain nutrients, with

the resulting possibility of adverse effects. Though health-conscious

individuals are likely to be focused on ensuring that they meet the

recommendations for essential nutrients, the combined effects of eating

fortified foods, taking MVMs, and consuming single vitamins or minerals

in large doses, may lead them to unwittingly exceed the Upper Levels

(ULs) of nutrients, which can be harmful.

Given these safety concerns and the limitations of the available

evidence, the panel advocated for changes in the regulation of dietary

supplements -- including MVMs -- by the Food and Drug Administration

(FDA). Specifically, the panel recommends that Congress expand FDA's

authority and resources to require manufacturers to disclose adverse

events, to ensure quality production, and to facilitate consumer

reporting of adverse events by including reporting information on

dietary supplement labels.

The panel also made several specific recommendations regarding future

research, including but not limited to the following:

-- Design and conduct rigorous randomized, controlled trials of the

impact of individual supplements to test their efficacy and safety in

prevention of chronic disease, using well-validated measures

-- Build new MVM databases that detail the exact composition of

supplements, update them on a continuous basis, and assure their

constant availability to the research community

-- Develop a strategy to support a better understanding of possible

interactions between MVMs and prescribed or over-the-counter

medications.

The 13-member panel included experts in the fields of food science and

human nutrition, biostatistics, biochemistry, toxicology, geriatric

medicine, family medicine, pediatrics and pediatric endocrinology,

cancer prevention, epidemiology, disease prevention and health

promotion, and consumer protection. A brief biography on Dr. McGinnis is

available at http://www.iom.edu/?id=28194. A listing of the panel

members and their institutional affiliations is included in the draft

conference statement.

In addition to the material presented at the conference by speakers and

the comments and concerns of conference participants presented during

discussion periods, the panel considered pertinent research from the

published literature and the results of a systematic review of the

literature commissioned by the NIH Office of Medical Applications of

Research (OMAR). The systematic review was prepared through the Agency

for Healthcare Research and Quality (AHRQ) Evidence-based Practice

Center (EPC) program, by the s Hopkins University Evidence-based

Practice Center. The EPCs develop evidence reports and technology

assessments based on rigorous, comprehensive syntheses and analyses of

the scientific literature, emphasizing explicit and detailed

documentation of methods, rationale, and assumptions. The evidence

report on Multivitamin/Mineral Supplements and Prevention of Chronic

Diseases is available at http://www.ahrq.gov/clinic/tp/multivittp.htm.

The panel's statement is an independent report and is not a policy

statement of the NIH or the federal government. The NIH Consensus

Development Program, of which this conference is a part, was established

in 1977 as a mechanism to judge controversial topics in medicine and

public health in an unbiased, impartial manner. NIH has conducted 118

consensus development conferences, and 27 state-of-the-science (formerly

" technology assessment " ) conferences, addressing a wide range of issues.

A backgrounder on the NIH Consensus Development Program process is

available at http://consensus.nih.gov/forthemedia.htm.

Interviews with panel members can be arranged by calling Kelli Marciel

at 301-496-4819 or via e-mail to marcielk@....

PRESS CONFERENCE:

Reporters can view the press conference at 2:00 pm today and submit

questions at http://videocast.nih.gov/ or send questions to

marcielk@... before 2:45 pm.

NOTE TO TV EDITORS:

The press conference will be broadcast live via satellite at the

following coordinates:

C-Band Galaxy 3C

Transponder: 21C

Orbital Location: 95 degrees west

Downlink Frequency: 4120 H

Audio: 6.2/6.8

Test time: 1:30-2:00 p.m. ET

Broadcast: 2:00-3:00 p.m. ET

NOTE TO RADIO EDITORS:

An audio report of the conference results will be available after 5:00

p.m. Wednesday, May 17 from the NIH Radio News Service by calling

1-800-MED-DIAL (1-800-633-3425) or visiting

http://www.nih.gov/news/radio/index.htm.

The Office of the Director, the central office at NIH, is responsible

for setting policy for NIH, which includes 27 Institutes and Centers.

This involves planning, managing, and coordinating the programs and

activities of all NIH components. The Office of the Director also

includes program offices which are responsible for stimulating specific

areas of research throughout NIH. Additional information is available at

http://www.nih.gov/icd/od/.

The National Institutes of Health (NIH) -- " The Nation's Medical

Research Agency " -- includes 27 Institutes and Centers and is a

component of the U.S. Department of Health and Human Services. It is the

primary federal agency for conducting and supporting basic, clinical and

translational medical research, and it investigates the causes,

treatments, and cures for both common and rare diseases. For more

information about NIH and its programs, visit www.nih.gov.

##

This NIH News Release is available online at:

http://www.nih.gov/news/pr/may2006/od-17.htm.

To subscribe (or unsubscribe) from this list, go to

http://list.nih.gov/cgi-bin/wa?SUBED1=nihpress & A=1.

_________________________________________________________________

Don’t just search. Find. Check out the new MSN Search!

http://search.msn.click-url.com/go/onm00200636ave/direct/01/

[Guest guest]

U.S. Department of Health and Human Services

NATIONAL INSTITUTES OF HEALTH

NIH News

NIH Office of the Director (OD)

http://www.nih.gov/icd/od/

Office of Medical Applications of Research (OMAR)

http://odp.od.nih.gov/omar/

FOR IMMEDIATE RELEASE: Wednesday, May 17, 2006

CONTACT: Kelli Marciel (OMAR), marcielk@..., 301-496-4819

NIH STATE-OF-THE-SCIENCE PANEL URGES MORE INFORMED APPROACH TO

MULTIVITAMIN/MINERAL USE FOR CHRONIC DISEASE PREVENTION

PANEL CALLS FOR EXPANDED OVERSIGHT OF VITAMIN AND MINERAL SUPPLEMENTS

An independent panel convened this week by the NIH Office of Medical

Applications of Research and the Office of Dietary Supplements assessed

the available evidence on the safety and effectiveness of

multivitamin/minerals (MVMs). Following two days of expert

presentations, public discussion, and panel deliberations, the panel

made recommendations regarding certain specific supplements but

ultimately concluded that more rigorous scientific research is needed

before strong recommendations can be made regarding MVM use to prevent

chronic diseases.

The panel released a draft statement of its findings this morning, at

the close of the conference. The panel's findings pertain to the

generally healthy population, and do not include pregnant women,

children, or those with disease. Full text of the panel's draft

state-of-the-science statement will be available late today at

http://consensus.nih.gov. The final version will be available at the

same Web site in four to six weeks.

" Half of American adults are taking MVMs and the bottom line is that we

don't know for sure that they're benefiting from them. In fact, we're

concerned that some people may be getting too much of certain

nutrients, " said J. McGinnis, M.D., M.P.P., Senior Scholar with

the Institute of Medicine of the National Academy of Sciences, who

chaired the panel.

The panel recommended the combined use of calcium and vitamin D

supplementation for postmenopausal women to protect bone health. The

panel also advocated that anti-oxidants and zinc be considered for use

by non-smoking adults with early-stage, age-related macular

degeneration, an eye condition that can cause blindness. The panel

supports previous recommendations by the CDC that women of childbearing

age take daily folate to prevent neural tube defects (birth defects of

the brain and spinal cord) in infants. Conversely, it found no evidence

to recommend beta carotene supplements, a form of vitamin A, for the

general population, and strong evidence to caution smokers against

taking them. Specifically, beta-carotene was linked to an increase in

lung cancer among smokers who took the vitamin regularly.

In looking specifically at MVMs for chronic disease prevention, however,

the panel found that the available data are insufficient to make a firm

recommendation for or against their use in the general population.

Of note, rates of MVM use are highest among those who engage in other

positive health behaviors such as regular exercise and eating a

healthier diet, making it difficult to determine whether the MVM alone

is truly responsible for any observed improvement in health.

Most of the public assumes that the components of MVM supplements are

safe, because many of the ingredients are found in everyday foods and

the products are available over-the-counter. The panel identified

several possible risks associated with MVM consumption, however. Among

these is the potential for overconsumption of certain nutrients, with

the resulting possibility of adverse effects. Though health-conscious

individuals are likely to be focused on ensuring that they meet the

recommendations for essential nutrients, the combined effects of eating

fortified foods, taking MVMs, and consuming single vitamins or minerals

in large doses, may lead them to unwittingly exceed the Upper Levels

(ULs) of nutrients, which can be harmful.

Given these safety concerns and the limitations of the available

evidence, the panel advocated for changes in the regulation of dietary

supplements -- including MVMs -- by the Food and Drug Administration

(FDA). Specifically, the panel recommends that Congress expand FDA's

authority and resources to require manufacturers to disclose adverse

events, to ensure quality production, and to facilitate consumer

reporting of adverse events by including reporting information on

dietary supplement labels.

The panel also made several specific recommendations regarding future

research, including but not limited to the following:

-- Design and conduct rigorous randomized, controlled trials of the

impact of individual supplements to test their efficacy and safety in

prevention of chronic disease, using well-validated measures

-- Build new MVM databases that detail the exact composition of

supplements, update them on a continuous basis, and assure their

constant availability to the research community

-- Develop a strategy to support a better understanding of possible

interactions between MVMs and prescribed or over-the-counter

medications.

The 13-member panel included experts in the fields of food science and

human nutrition, biostatistics, biochemistry, toxicology, geriatric

medicine, family medicine, pediatrics and pediatric endocrinology,

cancer prevention, epidemiology, disease prevention and health

promotion, and consumer protection. A brief biography on Dr. McGinnis is

available at http://www.iom.edu/?id=28194. A listing of the panel

members and their institutional affiliations is included in the draft

conference statement.

In addition to the material presented at the conference by speakers and

the comments and concerns of conference participants presented during

discussion periods, the panel considered pertinent research from the

published literature and the results of a systematic review of the

literature commissioned by the NIH Office of Medical Applications of

Research (OMAR). The systematic review was prepared through the Agency

for Healthcare Research and Quality (AHRQ) Evidence-based Practice

Center (EPC) program, by the s Hopkins University Evidence-based

Practice Center. The EPCs develop evidence reports and technology

assessments based on rigorous, comprehensive syntheses and analyses of

the scientific literature, emphasizing explicit and detailed

documentation of methods, rationale, and assumptions. The evidence

report on Multivitamin/Mineral Supplements and Prevention of Chronic

Diseases is available at http://www.ahrq.gov/clinic/tp/multivittp.htm.

The panel's statement is an independent report and is not a policy

statement of the NIH or the federal government. The NIH Consensus

Development Program, of which this conference is a part, was established

in 1977 as a mechanism to judge controversial topics in medicine and

public health in an unbiased, impartial manner. NIH has conducted 118

consensus development conferences, and 27 state-of-the-science (formerly

" technology assessment " ) conferences, addressing a wide range of issues.

A backgrounder on the NIH Consensus Development Program process is

available at http://consensus.nih.gov/forthemedia.htm.

Interviews with panel members can be arranged by calling Kelli Marciel

at 301-496-4819 or via e-mail to marcielk@....

PRESS CONFERENCE:

Reporters can view the press conference at 2:00 pm today and submit

questions at http://videocast.nih.gov/ or send questions to

marcielk@... before 2:45 pm.

NOTE TO TV EDITORS:

The press conference will be broadcast live via satellite at the

following coordinates:

C-Band Galaxy 3C

Transponder: 21C

Orbital Location: 95 degrees west

Downlink Frequency: 4120 H

Audio: 6.2/6.8

Test time: 1:30-2:00 p.m. ET

Broadcast: 2:00-3:00 p.m. ET

NOTE TO RADIO EDITORS:

An audio report of the conference results will be available after 5:00

p.m. Wednesday, May 17 from the NIH Radio News Service by calling

1-800-MED-DIAL (1-800-633-3425) or visiting

http://www.nih.gov/news/radio/index.htm.

The Office of the Director, the central office at NIH, is responsible

for setting policy for NIH, which includes 27 Institutes and Centers.

This involves planning, managing, and coordinating the programs and

activities of all NIH components. The Office of the Director also

includes program offices which are responsible for stimulating specific

areas of research throughout NIH. Additional information is available at

http://www.nih.gov/icd/od/.

The National Institutes of Health (NIH) -- " The Nation's Medical

Research Agency " -- includes 27 Institutes and Centers and is a

component of the U.S. Department of Health and Human Services. It is the

primary federal agency for conducting and supporting basic, clinical and

translational medical research, and it investigates the causes,

treatments, and cures for both common and rare diseases. For more

information about NIH and its programs, visit www.nih.gov.

##

This NIH News Release is available online at:

http://www.nih.gov/news/pr/may2006/od-17.htm.

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