Jonathan Gardner

PARIS — A worldwide influenza pandemic resulting from a mutation of the H5N1 avian influenza virus could restrain global economic growth by as much as $2 trillion, or more than 3%, as a result of voluntary or mandatory restrictions on travel, trade, and public interaction, a World Bank economist said at an international conference on avian influenza in humans.

Other effects that could restrict world economic growth are reductions in labor productivity because of absenteeism and increased costs related to hospitalization and health care, Milan Brahmbhatt, the World Bank's lead economist for East Asia and the Pacific, told the gathering of international public health officials.

In addition to the loss of lives, the threat to economic productivity demonstrates the value of preventing the avian flu virus from mutating to a form that can be passed easily from human to human.

“The general problem of global infectious diseases is going to be with us for a long time and may get worse,” Mr. Brahmbhatt said. “Thus it makes sense to also undertake broader long-term measures to strengthen the early detection, surveillance, institutional, regulatory, and technical capacity of the animal health, human health, and other relevant sectors. These will be valuable investments both in the short and long run.”

World Bank modeling and previous research suggests that, in the event of a severe pandemic on the scale of the 1918–1919 outbreak, 70 million people could die, which would reduce economic output by 0.4%. The short-run costs of illness, such as absenteeism and health care costs, would cut global economic output by another 0.9%.

In the event of a mild outbreak, such as the 1968 flu pandemic, analyses indicate that the United States could experience 100,000–200,000 deaths, 700,000 additional hospitalizations, and 40 million more outpatient visits, Mr. Brahmbhatt said.

PARIS — A worldwide influenza pandemic resulting from a mutation of the H5N1 avian influenza virus could restrain global economic growth by as much as $2 trillion, or more than 3%, as a result of voluntary or mandatory restrictions on travel, trade, and public interaction, a World Bank economist said at an international conference on avian influenza in humans.

Other effects that could restrict world economic growth are reductions in labor productivity because of absenteeism and increased costs related to hospitalization and health care, Milan Brahmbhatt, the World Bank's lead economist for East Asia and the Pacific, told the gathering of international public health officials.

In addition to the loss of lives, the threat to economic productivity demonstrates the value of preventing the avian flu virus from mutating to a form that can be passed easily from human to human.

“The general problem of global infectious diseases is going to be with us for a long time and may get worse,” Mr. Brahmbhatt said. “Thus it makes sense to also undertake broader long-term measures to strengthen the early detection, surveillance, institutional, regulatory, and technical capacity of the animal health, human health, and other relevant sectors. These will be valuable investments both in the short and long run.”

World Bank modeling and previous research suggests that, in the event of a severe pandemic on the scale of the 1918–1919 outbreak, 70 million people could die, which would reduce economic output by 0.4%. The short-run costs of illness, such as absenteeism and health care costs, would cut global economic output by another 0.9%.

In the event of a mild outbreak, such as the 1968 flu pandemic, analyses indicate that the United States could experience 100,000–200,000 deaths, 700,000 additional hospitalizations, and 40 million more outpatient visits, Mr. Brahmbhatt said.

PARIS — A worldwide influenza pandemic resulting from a mutation of the H5N1 avian influenza virus could restrain global economic growth by as much as $2 trillion, or more than 3%, as a result of voluntary or mandatory restrictions on travel, trade, and public interaction, a World Bank economist said at an international conference on avian influenza in humans.

Other effects that could restrict world economic growth are reductions in labor productivity because of absenteeism and increased costs related to hospitalization and health care, Milan Brahmbhatt, the World Bank's lead economist for East Asia and the Pacific, told the gathering of international public health officials.

In addition to the loss of lives, the threat to economic productivity demonstrates the value of preventing the avian flu virus from mutating to a form that can be passed easily from human to human.

“The general problem of global infectious diseases is going to be with us for a long time and may get worse,” Mr. Brahmbhatt said. “Thus it makes sense to also undertake broader long-term measures to strengthen the early detection, surveillance, institutional, regulatory, and technical capacity of the animal health, human health, and other relevant sectors. These will be valuable investments both in the short and long run.”

World Bank modeling and previous research suggests that, in the event of a severe pandemic on the scale of the 1918–1919 outbreak, 70 million people could die, which would reduce economic output by 0.4%. The short-run costs of illness, such as absenteeism and health care costs, would cut global economic output by another 0.9%.

In the event of a mild outbreak, such as the 1968 flu pandemic, analyses indicate that the United States could experience 100,000–200,000 deaths, 700,000 additional hospitalizations, and 40 million more outpatient visits, Mr. Brahmbhatt said.

The World Health Organization and the United Nations Children's Fund have completed a plan to expand access to essential pediatric medicines in developing countries.

Completed in a meeting last month of government officials and leaders of nongovernment organizations, the plan will target medicine for conditions such as diarrhea, HIV/AIDS, respiratory tract infections, malaria, and pneumonia.

A top priority will be to expand access to combination therapies to aid correct use and adherence.

Priority needs are respiratory infections, neonatal care, pain relief for end-stage AIDS, and coinfection of HIV and tuberculosis.

The plan also emphasizes new formulations, including minitablets, replacement of injections with pain-free medications, better-tasting formulations, and refrigeration-free and easily transportable mixtures.

“Too often, the right medicines for children, in the right dosages and formulations, are missing from the spectrum of available treatment options,” said Dr. Howard Zucker, assistant director-general at WHO.

“WHO and UNICEF will work quickly with partners to change this,” Dr. Zucker said.

The World Health Organization and the United Nations Children's Fund have completed a plan to expand access to essential pediatric medicines in developing countries.

Completed in a meeting last month of government officials and leaders of nongovernment organizations, the plan will target medicine for conditions such as diarrhea, HIV/AIDS, respiratory tract infections, malaria, and pneumonia.

A top priority will be to expand access to combination therapies to aid correct use and adherence.

Priority needs are respiratory infections, neonatal care, pain relief for end-stage AIDS, and coinfection of HIV and tuberculosis.

The plan also emphasizes new formulations, including minitablets, replacement of injections with pain-free medications, better-tasting formulations, and refrigeration-free and easily transportable mixtures.

“Too often, the right medicines for children, in the right dosages and formulations, are missing from the spectrum of available treatment options,” said Dr. Howard Zucker, assistant director-general at WHO.

“WHO and UNICEF will work quickly with partners to change this,” Dr. Zucker said.

The World Health Organization and the United Nations Children's Fund have completed a plan to expand access to essential pediatric medicines in developing countries.

Completed in a meeting last month of government officials and leaders of nongovernment organizations, the plan will target medicine for conditions such as diarrhea, HIV/AIDS, respiratory tract infections, malaria, and pneumonia.

A top priority will be to expand access to combination therapies to aid correct use and adherence.

Priority needs are respiratory infections, neonatal care, pain relief for end-stage AIDS, and coinfection of HIV and tuberculosis.

The plan also emphasizes new formulations, including minitablets, replacement of injections with pain-free medications, better-tasting formulations, and refrigeration-free and easily transportable mixtures.

“Too often, the right medicines for children, in the right dosages and formulations, are missing from the spectrum of available treatment options,” said Dr. Howard Zucker, assistant director-general at WHO.

“WHO and UNICEF will work quickly with partners to change this,” Dr. Zucker said.

Increasing numbers of drug users seeking addiction treatment in one region in England have led to a decrease in the proportion of addiction patients who are discharged drug-free and an increase in the proportion who drop out, a new study has found.

The investigators examined outcomes for drug treatment in 26,415 patients in Cheshire and Merseyside in England from 1997 to 2005 to identify those who were in treatment from 1998 through 2002 (BMC Public Health 2006;6:205 [doi:10.1186/1471-2458-6-205]). The period examined coincides with the launch of a national drug strategy that increased the number of treatment personnel and reduced waiting times.

In Cheshire and Merseyside, the number of patients rose from 7,594 in 1998 to 11,530 in 2004/2005, mirroring an increase in the health care system's capacity to treat addiction.

Over the course of the longitudinal study, the researchers found that the proportion of individuals who completed their course of treatment drug-free decreased from 5.8% in 1998 to 3.5% in 2001/2002 (record-keeping changed from a calendar-year basis to a fiscal-year basis in 2000), and the percentage of dropouts increased from 7.2% to 9.6%.

Younger patients were more likely to drop out, as were patients seen in the later years of the study.

The researchers also found an increase in the percentage of patients who had been discharged drug-free and returned for treatment the following year: up from 27.8% in 1998 to 44.5% in 2001/2002. The percentage of patients who dropped out and then returned the following year also increased: 22.9% in 1998 to 48.6% in 2001/2002.

Older patients were more likely to return for further treatment, as were patients who had prior addiction treatment histories. Patients who were referred to treatment through the criminal justice system were much less likely to complete treatment, the researchers found. In 2001/2002, for example, 14% of the patients who came in from the criminal justice system were discharged drug-free, compared with 30.9% of those who came from other sources.

The researchers argued that the drug users referred to treatment in exchange for a lighter sentence in court may not have the same motivation as those who enter treatment voluntarily.

“Once in treatment, practitioners therefore face the challenge of shifting a drug user's motivation from external to internal incentives,” wrote the researchers. “If measures to increase uptake become more coercive, treatment must be flexible to adapt to drug users who may be very different from ones who voluntarily seek assistance.”

Increasing numbers of drug users seeking addiction treatment in one region in England have led to a decrease in the proportion of addiction patients who are discharged drug-free and an increase in the proportion who drop out, a new study has found.

The investigators examined outcomes for drug treatment in 26,415 patients in Cheshire and Merseyside in England from 1997 to 2005 to identify those who were in treatment from 1998 through 2002 (BMC Public Health 2006;6:205 [doi:10.1186/1471-2458-6-205]). The period examined coincides with the launch of a national drug strategy that increased the number of treatment personnel and reduced waiting times.

In Cheshire and Merseyside, the number of patients rose from 7,594 in 1998 to 11,530 in 2004/2005, mirroring an increase in the health care system's capacity to treat addiction.

Over the course of the longitudinal study, the researchers found that the proportion of individuals who completed their course of treatment drug-free decreased from 5.8% in 1998 to 3.5% in 2001/2002 (record-keeping changed from a calendar-year basis to a fiscal-year basis in 2000), and the percentage of dropouts increased from 7.2% to 9.6%.

Younger patients were more likely to drop out, as were patients seen in the later years of the study.

The researchers also found an increase in the percentage of patients who had been discharged drug-free and returned for treatment the following year: up from 27.8% in 1998 to 44.5% in 2001/2002. The percentage of patients who dropped out and then returned the following year also increased: 22.9% in 1998 to 48.6% in 2001/2002.

Older patients were more likely to return for further treatment, as were patients who had prior addiction treatment histories. Patients who were referred to treatment through the criminal justice system were much less likely to complete treatment, the researchers found. In 2001/2002, for example, 14% of the patients who came in from the criminal justice system were discharged drug-free, compared with 30.9% of those who came from other sources.

The researchers argued that the drug users referred to treatment in exchange for a lighter sentence in court may not have the same motivation as those who enter treatment voluntarily.

“Once in treatment, practitioners therefore face the challenge of shifting a drug user's motivation from external to internal incentives,” wrote the researchers. “If measures to increase uptake become more coercive, treatment must be flexible to adapt to drug users who may be very different from ones who voluntarily seek assistance.”

Increasing numbers of drug users seeking addiction treatment in one region in England have led to a decrease in the proportion of addiction patients who are discharged drug-free and an increase in the proportion who drop out, a new study has found.

The investigators examined outcomes for drug treatment in 26,415 patients in Cheshire and Merseyside in England from 1997 to 2005 to identify those who were in treatment from 1998 through 2002 (BMC Public Health 2006;6:205 [doi:10.1186/1471-2458-6-205]). The period examined coincides with the launch of a national drug strategy that increased the number of treatment personnel and reduced waiting times.

In Cheshire and Merseyside, the number of patients rose from 7,594 in 1998 to 11,530 in 2004/2005, mirroring an increase in the health care system's capacity to treat addiction.

Over the course of the longitudinal study, the researchers found that the proportion of individuals who completed their course of treatment drug-free decreased from 5.8% in 1998 to 3.5% in 2001/2002 (record-keeping changed from a calendar-year basis to a fiscal-year basis in 2000), and the percentage of dropouts increased from 7.2% to 9.6%.

Younger patients were more likely to drop out, as were patients seen in the later years of the study.

The researchers also found an increase in the percentage of patients who had been discharged drug-free and returned for treatment the following year: up from 27.8% in 1998 to 44.5% in 2001/2002. The percentage of patients who dropped out and then returned the following year also increased: 22.9% in 1998 to 48.6% in 2001/2002.

Older patients were more likely to return for further treatment, as were patients who had prior addiction treatment histories. Patients who were referred to treatment through the criminal justice system were much less likely to complete treatment, the researchers found. In 2001/2002, for example, 14% of the patients who came in from the criminal justice system were discharged drug-free, compared with 30.9% of those who came from other sources.

The researchers argued that the drug users referred to treatment in exchange for a lighter sentence in court may not have the same motivation as those who enter treatment voluntarily.

“Once in treatment, practitioners therefore face the challenge of shifting a drug user's motivation from external to internal incentives,” wrote the researchers. “If measures to increase uptake become more coercive, treatment must be flexible to adapt to drug users who may be very different from ones who voluntarily seek assistance.”

GlaxoSmithKline has announced that its H5N1 vaccine achieved a high immune response in a clinical trial in Belgium.

Investigators immunized 400 healthy adults with a vaccine that contained an inactivated H5N1 virus and a proprietary adjuvant. Subjects were vaccinated twice.

The lowest strength tested was 3.8 mcg of antigen, along with three higher doses. At 3.8 mcg, 80% of the patients demonstrated a seroprotective response.

The vaccine has not received marketing approval from any regulatory agency, although Jean-Pierre Garnier, GSK's chief executive officer, said the company will apply for approval in the coming months.

“This is the first time such a low dose of H5N1 antigen has been able to stimulate this level of strong immune response,” Mr. Garnier said. “There is still a lot more work to be done with this program, but this validation of our approach provides us with the confidence to continue developing the vaccine, including assessment of its ability to offer cross-protection to variants of the H5N1 strain.”

GlaxoSmithKline has announced that its H5N1 vaccine achieved a high immune response in a clinical trial in Belgium.

Investigators immunized 400 healthy adults with a vaccine that contained an inactivated H5N1 virus and a proprietary adjuvant. Subjects were vaccinated twice.

The lowest strength tested was 3.8 mcg of antigen, along with three higher doses. At 3.8 mcg, 80% of the patients demonstrated a seroprotective response.

The vaccine has not received marketing approval from any regulatory agency, although Jean-Pierre Garnier, GSK's chief executive officer, said the company will apply for approval in the coming months.

“This is the first time such a low dose of H5N1 antigen has been able to stimulate this level of strong immune response,” Mr. Garnier said. “There is still a lot more work to be done with this program, but this validation of our approach provides us with the confidence to continue developing the vaccine, including assessment of its ability to offer cross-protection to variants of the H5N1 strain.”

GlaxoSmithKline has announced that its H5N1 vaccine achieved a high immune response in a clinical trial in Belgium.

Investigators immunized 400 healthy adults with a vaccine that contained an inactivated H5N1 virus and a proprietary adjuvant. Subjects were vaccinated twice.

The lowest strength tested was 3.8 mcg of antigen, along with three higher doses. At 3.8 mcg, 80% of the patients demonstrated a seroprotective response.

The vaccine has not received marketing approval from any regulatory agency, although Jean-Pierre Garnier, GSK's chief executive officer, said the company will apply for approval in the coming months.

“This is the first time such a low dose of H5N1 antigen has been able to stimulate this level of strong immune response,” Mr. Garnier said. “There is still a lot more work to be done with this program, but this validation of our approach provides us with the confidence to continue developing the vaccine, including assessment of its ability to offer cross-protection to variants of the H5N1 strain.”

The European Medicines Agency has approved the first two avian influenza vaccines for birds that the agency says will reduce mortality and virus excretion in poultry exposed to the disease.

The European Medicines Agency (EMEA) gave a positive opinion to Nobilis Influenza H5N2 from Intervet International BV, a subsidiary of Netherlands-based Akzo Nobel BV, and Poulvac FluFend H5N3 RG from Fort Dodge Animal Health, a division of U.S.-based Wyeth.

Both are inactive, adjuvanted avian influenza vaccines administered by injection. Nobilis is for use in chickens, and Poulvac is intended for use in chickens and Pekin ducks.

The agency's Committee for Medicinal Products for Veterinary Use approved the vaccines under “exceptional circumstances,” anticipating a period of high risk for infection in the autumn and winter. The committee decided that the benefit of using the vaccines outweighed the risks but will review the vaccines annually.

Under the approval, EMEA also requires enhanced safety monitoring by the two manufacturers.

London-based EMEA is a division of the European Union that offers pharmaceutical manufacturers a way to obtain a single approval for the 25 EU countries. A positive opinion from EMEA is forwarded to the European Commission for single marketing approval.

Many experts believe reducing the number of H5N1 infections in birds may be the best path to preventing a pandemic outbreak in humans.

The density of both humans and poultry in the world, coupled with trade, travel, and a history of avian influenza virus strains that mutate into forms that spread easily among humans, means “all the ingredients are in place for the occurrence of another pandemic,” said Dr. Didier Houssin, interministry delegate for the fight against avian influenza in the French Ministry of Health, Paris.

“Prevention of human contamination should also be the first line of defense against a potential human pandemic,” Dr. Houssin told the First International Conference on Avian Influenza in Humans.

Among the strategies countries should consider is the vaccination of poultry, although he warned that this step may not always prevent avian influenza from entering a country. “Measures taken at the country level are not sufficient, because wild birds know no or almost no frontiers,” Dr. Houssin said.

The European Medicines Agency has approved the first two avian influenza vaccines for birds that the agency says will reduce mortality and virus excretion in poultry exposed to the disease.

The European Medicines Agency (EMEA) gave a positive opinion to Nobilis Influenza H5N2 from Intervet International BV, a subsidiary of Netherlands-based Akzo Nobel BV, and Poulvac FluFend H5N3 RG from Fort Dodge Animal Health, a division of U.S.-based Wyeth.

Both are inactive, adjuvanted avian influenza vaccines administered by injection. Nobilis is for use in chickens, and Poulvac is intended for use in chickens and Pekin ducks.

The agency's Committee for Medicinal Products for Veterinary Use approved the vaccines under “exceptional circumstances,” anticipating a period of high risk for infection in the autumn and winter. The committee decided that the benefit of using the vaccines outweighed the risks but will review the vaccines annually.

Under the approval, EMEA also requires enhanced safety monitoring by the two manufacturers.

London-based EMEA is a division of the European Union that offers pharmaceutical manufacturers a way to obtain a single approval for the 25 EU countries. A positive opinion from EMEA is forwarded to the European Commission for single marketing approval.

Many experts believe reducing the number of H5N1 infections in birds may be the best path to preventing a pandemic outbreak in humans.

The density of both humans and poultry in the world, coupled with trade, travel, and a history of avian influenza virus strains that mutate into forms that spread easily among humans, means “all the ingredients are in place for the occurrence of another pandemic,” said Dr. Didier Houssin, interministry delegate for the fight against avian influenza in the French Ministry of Health, Paris.

“Prevention of human contamination should also be the first line of defense against a potential human pandemic,” Dr. Houssin told the First International Conference on Avian Influenza in Humans.

Among the strategies countries should consider is the vaccination of poultry, although he warned that this step may not always prevent avian influenza from entering a country. “Measures taken at the country level are not sufficient, because wild birds know no or almost no frontiers,” Dr. Houssin said.

The European Medicines Agency has approved the first two avian influenza vaccines for birds that the agency says will reduce mortality and virus excretion in poultry exposed to the disease.

The European Medicines Agency (EMEA) gave a positive opinion to Nobilis Influenza H5N2 from Intervet International BV, a subsidiary of Netherlands-based Akzo Nobel BV, and Poulvac FluFend H5N3 RG from Fort Dodge Animal Health, a division of U.S.-based Wyeth.

Both are inactive, adjuvanted avian influenza vaccines administered by injection. Nobilis is for use in chickens, and Poulvac is intended for use in chickens and Pekin ducks.

The agency's Committee for Medicinal Products for Veterinary Use approved the vaccines under “exceptional circumstances,” anticipating a period of high risk for infection in the autumn and winter. The committee decided that the benefit of using the vaccines outweighed the risks but will review the vaccines annually.

Under the approval, EMEA also requires enhanced safety monitoring by the two manufacturers.

London-based EMEA is a division of the European Union that offers pharmaceutical manufacturers a way to obtain a single approval for the 25 EU countries. A positive opinion from EMEA is forwarded to the European Commission for single marketing approval.

Many experts believe reducing the number of H5N1 infections in birds may be the best path to preventing a pandemic outbreak in humans.

The density of both humans and poultry in the world, coupled with trade, travel, and a history of avian influenza virus strains that mutate into forms that spread easily among humans, means “all the ingredients are in place for the occurrence of another pandemic,” said Dr. Didier Houssin, interministry delegate for the fight against avian influenza in the French Ministry of Health, Paris.

“Prevention of human contamination should also be the first line of defense against a potential human pandemic,” Dr. Houssin told the First International Conference on Avian Influenza in Humans.

Among the strategies countries should consider is the vaccination of poultry, although he warned that this step may not always prevent avian influenza from entering a country. “Measures taken at the country level are not sufficient, because wild birds know no or almost no frontiers,” Dr. Houssin said.

PARIS — Public health authorities should develop a research agenda on the use of statins as treatment and prophylaxis in the event of an influenza pandemic, a top researcher said at an international conference on avian influenza in humans.

Data suggest that statins could be useful in combating such side effects as pneumonia, sepsis, bacteremia, and pulmonary disease, said Dr. David Fedson, coordinator of the Macroepidemiology of Influenza Vaccination (MIV) Study Group and a former professor of medicine at the University of Virginia, Charlottesville. Statins could be an alternative treatment in the first wave of a pandemic, when vaccines may be unavailable.

Statins can interfere with inflammation and with virus transport, assembly, and budding, while aiding endothelial and epithelial cell function and immune response, Dr. Fedson said. These qualities could make statins an effective treatment option in the event that avian influenza H5N1 mutates into a form that can infect humans more easily.

Should such a mutation take place, vaccine manufacturers first will need to match their vaccine to the virus and then ramp up production, which will mean that the first regions to be affected could be defenseless against the pandemic.

“In the event of an H5N1 pandemic, the global demand will easily be on the order of 3–4 billion doses, and probably much more,” Dr. Fedson said.

“Yet today, if the world's vaccines companies were asked to produce [vaccine], in 6 months they could produce enough … to vaccinate fewer than 100 million people. Vaccination will not be a realistic possibility for 85% of the world's population that do not live in countries with vaccine companies, and it will be difficult even for those who do,” he said.

By comparison, generic statins are inexpensive—$1.75 for 5 days' worth of dosage in the United States—and they can be produced worldwide, Dr. Fedson said.

Among the evidence in favor of statins' protective qualities, Dr. Fedson said, are studies showing a reduction of up to 92% in bacteremia-attributable mortality among patients who take statins; a reduction of up to 25% in sepsis mortality among patients who have previously taken statins; and a 53% reduction in 30-day pneumonia mortality among those patients who have taken statins.

However, international health officials need to embark on a statin research agenda to explore unanswered questions, Dr. Fedson said.

To understand whether statins are an option, researchers need to perform clinical and epidemiologic studies examining hospitalization and mortality.

They also must clearly compare the effects of previous statin use with continuing statin use, and compare treatment with prophylaxis. In addition, researchers need to do animal studies with mice, ferrets, and primates, and more clearly determine the molecular mechanism of action, he noted.

PARIS — Public health authorities should develop a research agenda on the use of statins as treatment and prophylaxis in the event of an influenza pandemic, a top researcher said at an international conference on avian influenza in humans.

Data suggest that statins could be useful in combating such side effects as pneumonia, sepsis, bacteremia, and pulmonary disease, said Dr. David Fedson, coordinator of the Macroepidemiology of Influenza Vaccination (MIV) Study Group and a former professor of medicine at the University of Virginia, Charlottesville. Statins could be an alternative treatment in the first wave of a pandemic, when vaccines may be unavailable.

Statins can interfere with inflammation and with virus transport, assembly, and budding, while aiding endothelial and epithelial cell function and immune response, Dr. Fedson said. These qualities could make statins an effective treatment option in the event that avian influenza H5N1 mutates into a form that can infect humans more easily.

Should such a mutation take place, vaccine manufacturers first will need to match their vaccine to the virus and then ramp up production, which will mean that the first regions to be affected could be defenseless against the pandemic.

“In the event of an H5N1 pandemic, the global demand will easily be on the order of 3–4 billion doses, and probably much more,” Dr. Fedson said.

“Yet today, if the world's vaccines companies were asked to produce [vaccine], in 6 months they could produce enough … to vaccinate fewer than 100 million people. Vaccination will not be a realistic possibility for 85% of the world's population that do not live in countries with vaccine companies, and it will be difficult even for those who do,” he said.

By comparison, generic statins are inexpensive—$1.75 for 5 days' worth of dosage in the United States—and they can be produced worldwide, Dr. Fedson said.

Among the evidence in favor of statins' protective qualities, Dr. Fedson said, are studies showing a reduction of up to 92% in bacteremia-attributable mortality among patients who take statins; a reduction of up to 25% in sepsis mortality among patients who have previously taken statins; and a 53% reduction in 30-day pneumonia mortality among those patients who have taken statins.

However, international health officials need to embark on a statin research agenda to explore unanswered questions, Dr. Fedson said.

To understand whether statins are an option, researchers need to perform clinical and epidemiologic studies examining hospitalization and mortality.

They also must clearly compare the effects of previous statin use with continuing statin use, and compare treatment with prophylaxis. In addition, researchers need to do animal studies with mice, ferrets, and primates, and more clearly determine the molecular mechanism of action, he noted.

PARIS — Public health authorities should develop a research agenda on the use of statins as treatment and prophylaxis in the event of an influenza pandemic, a top researcher said at an international conference on avian influenza in humans.

Data suggest that statins could be useful in combating such side effects as pneumonia, sepsis, bacteremia, and pulmonary disease, said Dr. David Fedson, coordinator of the Macroepidemiology of Influenza Vaccination (MIV) Study Group and a former professor of medicine at the University of Virginia, Charlottesville. Statins could be an alternative treatment in the first wave of a pandemic, when vaccines may be unavailable.

Statins can interfere with inflammation and with virus transport, assembly, and budding, while aiding endothelial and epithelial cell function and immune response, Dr. Fedson said. These qualities could make statins an effective treatment option in the event that avian influenza H5N1 mutates into a form that can infect humans more easily.

Should such a mutation take place, vaccine manufacturers first will need to match their vaccine to the virus and then ramp up production, which will mean that the first regions to be affected could be defenseless against the pandemic.

“In the event of an H5N1 pandemic, the global demand will easily be on the order of 3–4 billion doses, and probably much more,” Dr. Fedson said.

“Yet today, if the world's vaccines companies were asked to produce [vaccine], in 6 months they could produce enough … to vaccinate fewer than 100 million people. Vaccination will not be a realistic possibility for 85% of the world's population that do not live in countries with vaccine companies, and it will be difficult even for those who do,” he said.

By comparison, generic statins are inexpensive—$1.75 for 5 days' worth of dosage in the United States—and they can be produced worldwide, Dr. Fedson said.

Among the evidence in favor of statins' protective qualities, Dr. Fedson said, are studies showing a reduction of up to 92% in bacteremia-attributable mortality among patients who take statins; a reduction of up to 25% in sepsis mortality among patients who have previously taken statins; and a 53% reduction in 30-day pneumonia mortality among those patients who have taken statins.

However, international health officials need to embark on a statin research agenda to explore unanswered questions, Dr. Fedson said.

To understand whether statins are an option, researchers need to perform clinical and epidemiologic studies examining hospitalization and mortality.

They also must clearly compare the effects of previous statin use with continuing statin use, and compare treatment with prophylaxis. In addition, researchers need to do animal studies with mice, ferrets, and primates, and more clearly determine the molecular mechanism of action, he noted.

The European Medicines Agency has approved the first two avian influenza vaccines for birds that the agency says will reduce mortality and virus excretion in poultry exposed to the disease.

The European Medicines Agency (EMEA) gave a positive opinion to Nobilis Influenza H5N2 from Intervet International BV, a subsidiary of Netherlands-based Akzo Nobel BV, and Poulvac FluFend H5N3 RG from Fort Dodge Animal Health, a division of U.S.-based Wyeth.

Both are inactive, adjuvanted avian influenza vaccines administered by injection. Nobilis is for use in chickens, and Poulvac is intended for use in chickens and Pekin ducks.

The agency's Committee for Medicinal Products for Veterinary Use approved the vaccines under “exceptional circumstances,” anticipating a period of high risk for infection in the autumn and winter. The committee decided that the benefit of using the vaccines outweighed the risks but will review the vaccines annually.

Under the approval, EMEA also requires enhanced safety monitoring by the two manufacturers.

London-based EMEA is a division of the European Union that offers pharmaceutical manufacturers a way to obtain a single approval for the 25 EU countries. A positive opinion from EMEA is forwarded to the European Commission for single marketing approval.

Many experts believe reducing the number of H5N1 infections in birds may be the best path to preventing a pandemic outbreak in humans.

The density of both humans and poultry in the world, coupled with trade, travel, and a history of avian influenza virus strains that mutate into forms that spread easily among humans, means “all the ingredients are in place for the occurrence of another pandemic,” said Dr. Didier Houssin, interministry delegate for the fight against avian influenza in the French Ministry of Health, Paris.

“Prevention of human contamination should also be the first line of defense against a potential human pandemic,” Dr. Houssin told the First International Conference on Avian Influenza in Humans last month. Among the strategies countries should consider is the vaccination of poultry, although he warned that this step may not always prevent avian influenza from entering a country.

“Measures taken at the country level are not sufficient, because wild birds know no or almost no frontiers,” Dr. Houssin said.

The European Medicines Agency has approved the first two avian influenza vaccines for birds that the agency says will reduce mortality and virus excretion in poultry exposed to the disease.

The European Medicines Agency (EMEA) gave a positive opinion to Nobilis Influenza H5N2 from Intervet International BV, a subsidiary of Netherlands-based Akzo Nobel BV, and Poulvac FluFend H5N3 RG from Fort Dodge Animal Health, a division of U.S.-based Wyeth.

Both are inactive, adjuvanted avian influenza vaccines administered by injection. Nobilis is for use in chickens, and Poulvac is intended for use in chickens and Pekin ducks.

The agency's Committee for Medicinal Products for Veterinary Use approved the vaccines under “exceptional circumstances,” anticipating a period of high risk for infection in the autumn and winter. The committee decided that the benefit of using the vaccines outweighed the risks but will review the vaccines annually.

Under the approval, EMEA also requires enhanced safety monitoring by the two manufacturers.

London-based EMEA is a division of the European Union that offers pharmaceutical manufacturers a way to obtain a single approval for the 25 EU countries. A positive opinion from EMEA is forwarded to the European Commission for single marketing approval.

Many experts believe reducing the number of H5N1 infections in birds may be the best path to preventing a pandemic outbreak in humans.

The density of both humans and poultry in the world, coupled with trade, travel, and a history of avian influenza virus strains that mutate into forms that spread easily among humans, means “all the ingredients are in place for the occurrence of another pandemic,” said Dr. Didier Houssin, interministry delegate for the fight against avian influenza in the French Ministry of Health, Paris.

“Prevention of human contamination should also be the first line of defense against a potential human pandemic,” Dr. Houssin told the First International Conference on Avian Influenza in Humans last month. Among the strategies countries should consider is the vaccination of poultry, although he warned that this step may not always prevent avian influenza from entering a country.

“Measures taken at the country level are not sufficient, because wild birds know no or almost no frontiers,” Dr. Houssin said.

The European Medicines Agency has approved the first two avian influenza vaccines for birds that the agency says will reduce mortality and virus excretion in poultry exposed to the disease.

The European Medicines Agency (EMEA) gave a positive opinion to Nobilis Influenza H5N2 from Intervet International BV, a subsidiary of Netherlands-based Akzo Nobel BV, and Poulvac FluFend H5N3 RG from Fort Dodge Animal Health, a division of U.S.-based Wyeth.

Both are inactive, adjuvanted avian influenza vaccines administered by injection. Nobilis is for use in chickens, and Poulvac is intended for use in chickens and Pekin ducks.

The agency's Committee for Medicinal Products for Veterinary Use approved the vaccines under “exceptional circumstances,” anticipating a period of high risk for infection in the autumn and winter. The committee decided that the benefit of using the vaccines outweighed the risks but will review the vaccines annually.

Under the approval, EMEA also requires enhanced safety monitoring by the two manufacturers.

London-based EMEA is a division of the European Union that offers pharmaceutical manufacturers a way to obtain a single approval for the 25 EU countries. A positive opinion from EMEA is forwarded to the European Commission for single marketing approval.

Many experts believe reducing the number of H5N1 infections in birds may be the best path to preventing a pandemic outbreak in humans.

The density of both humans and poultry in the world, coupled with trade, travel, and a history of avian influenza virus strains that mutate into forms that spread easily among humans, means “all the ingredients are in place for the occurrence of another pandemic,” said Dr. Didier Houssin, interministry delegate for the fight against avian influenza in the French Ministry of Health, Paris.

“Prevention of human contamination should also be the first line of defense against a potential human pandemic,” Dr. Houssin told the First International Conference on Avian Influenza in Humans last month. Among the strategies countries should consider is the vaccination of poultry, although he warned that this step may not always prevent avian influenza from entering a country.

“Measures taken at the country level are not sufficient, because wild birds know no or almost no frontiers,” Dr. Houssin said.

PARIS — Public health authorities should develop a research agenda on the use of statins as treatment and prophylaxis in the event of an influenza pandemic, a top researcher said at an international conference on avian influenza in humans.

Data suggest statins could be useful in combating side effects such as pneumonia, sepsis, bacteremia, and pulmonary disease, said Dr. David Fedson, coordinator of the Macroepidemiology of Influenza Vaccination Study Group and a former professor of medicine at the University of Virginia, Charlottesville. They could be an alternative treatment in the first wave of a pandemic, when vaccines may not be available.

Statins can interfere with inflammation and with virus transport, assembly, and budding, while aiding endothelial and epithelial cell function and immune response, Dr. Fedson said. These qualities could make statins an effective treatment option in the event that avian influenza H5N1 mutates into a form that can infect humans more easily.

Should such a mutation take place, vaccine manufacturers first will need to match their vaccine to the virus and then ramp up production, which will mean that the first regions to be affected could be defenseless against the pandemic.

“In the event of an H5N1 pandemic, the global demand will easily be on the order of 3–4 billion doses, and probably much more,” Dr. Fedson said. “Yet today, if the world's vaccines companies were asked to produce [vaccine], in 6 months they could produce enough … to vaccinate fewer than 100 million people. Vaccination will not be a realistic possibility for 85% of the world's population that do not live in countries with vaccine companies, and it will be difficult even for those who do.”

By comparison, generic statins are inexpensive—$1.75 for 5 days' worth of dosage in the United States—and they can be produced worldwide, Dr. Fedson said.

Among the evidence in favor of statins' protective qualities, Dr. Fedson said, are studies showing a reduction of up to 92% in bacteremia-attributable mortality in patients who take statins; a reduction of up to 25% in sepsis mortality in those who have previously taken statins; and a 53% reduction in 30-day pneumonia mortality in those who have taken statins.

However, international health officials need to embark on a statin research agenda to explore unanswered questions, Dr. Fedson said. Researchers need to perform clinical and epidemiologic studies examining hospitalization and mortality. They also must compare the effects of previous statin use with continuing statin use and compare treatment with prophylaxis.

PARIS — Public health authorities should develop a research agenda on the use of statins as treatment and prophylaxis in the event of an influenza pandemic, a top researcher said at an international conference on avian influenza in humans.

Data suggest statins could be useful in combating side effects such as pneumonia, sepsis, bacteremia, and pulmonary disease, said Dr. David Fedson, coordinator of the Macroepidemiology of Influenza Vaccination Study Group and a former professor of medicine at the University of Virginia, Charlottesville. They could be an alternative treatment in the first wave of a pandemic, when vaccines may not be available.

Statins can interfere with inflammation and with virus transport, assembly, and budding, while aiding endothelial and epithelial cell function and immune response, Dr. Fedson said. These qualities could make statins an effective treatment option in the event that avian influenza H5N1 mutates into a form that can infect humans more easily.

Should such a mutation take place, vaccine manufacturers first will need to match their vaccine to the virus and then ramp up production, which will mean that the first regions to be affected could be defenseless against the pandemic.

“In the event of an H5N1 pandemic, the global demand will easily be on the order of 3–4 billion doses, and probably much more,” Dr. Fedson said. “Yet today, if the world's vaccines companies were asked to produce [vaccine], in 6 months they could produce enough … to vaccinate fewer than 100 million people. Vaccination will not be a realistic possibility for 85% of the world's population that do not live in countries with vaccine companies, and it will be difficult even for those who do.”

By comparison, generic statins are inexpensive—$1.75 for 5 days' worth of dosage in the United States—and they can be produced worldwide, Dr. Fedson said.

Among the evidence in favor of statins' protective qualities, Dr. Fedson said, are studies showing a reduction of up to 92% in bacteremia-attributable mortality in patients who take statins; a reduction of up to 25% in sepsis mortality in those who have previously taken statins; and a 53% reduction in 30-day pneumonia mortality in those who have taken statins.

However, international health officials need to embark on a statin research agenda to explore unanswered questions, Dr. Fedson said. Researchers need to perform clinical and epidemiologic studies examining hospitalization and mortality. They also must compare the effects of previous statin use with continuing statin use and compare treatment with prophylaxis.

PARIS — Public health authorities should develop a research agenda on the use of statins as treatment and prophylaxis in the event of an influenza pandemic, a top researcher said at an international conference on avian influenza in humans.

Data suggest statins could be useful in combating side effects such as pneumonia, sepsis, bacteremia, and pulmonary disease, said Dr. David Fedson, coordinator of the Macroepidemiology of Influenza Vaccination Study Group and a former professor of medicine at the University of Virginia, Charlottesville. They could be an alternative treatment in the first wave of a pandemic, when vaccines may not be available.

Statins can interfere with inflammation and with virus transport, assembly, and budding, while aiding endothelial and epithelial cell function and immune response, Dr. Fedson said. These qualities could make statins an effective treatment option in the event that avian influenza H5N1 mutates into a form that can infect humans more easily.

Should such a mutation take place, vaccine manufacturers first will need to match their vaccine to the virus and then ramp up production, which will mean that the first regions to be affected could be defenseless against the pandemic.

“In the event of an H5N1 pandemic, the global demand will easily be on the order of 3–4 billion doses, and probably much more,” Dr. Fedson said. “Yet today, if the world's vaccines companies were asked to produce [vaccine], in 6 months they could produce enough … to vaccinate fewer than 100 million people. Vaccination will not be a realistic possibility for 85% of the world's population that do not live in countries with vaccine companies, and it will be difficult even for those who do.”

By comparison, generic statins are inexpensive—$1.75 for 5 days' worth of dosage in the United States—and they can be produced worldwide, Dr. Fedson said.

Among the evidence in favor of statins' protective qualities, Dr. Fedson said, are studies showing a reduction of up to 92% in bacteremia-attributable mortality in patients who take statins; a reduction of up to 25% in sepsis mortality in those who have previously taken statins; and a 53% reduction in 30-day pneumonia mortality in those who have taken statins.

However, international health officials need to embark on a statin research agenda to explore unanswered questions, Dr. Fedson said. Researchers need to perform clinical and epidemiologic studies examining hospitalization and mortality. They also must compare the effects of previous statin use with continuing statin use and compare treatment with prophylaxis.

Adding metformin to a clomifene citrate regimen did not significantly increase the probability of ovulating or becoming pregnant in women who had polycystic ovary disease and were treated with clomifene citrate alone.

This conclusion was based on results of a trial conducted at 20 Dutch hospitals where 228 women were randomized to receive either clomifene citrate (Clomid) in combination with metformin (Glucophage) or clomifene citrate with a placebo (BMJ 2006;doi:10.1136/bmj.38867. 631551.55). The researchers, led by Etelka Moll, registrar for obstetrics and gynecology at the center for reproductive medicine at Academic Medical Center, Amsterdam, found comparable ovulation rates in the two groups, the primary outcome measure, and no statistically significant differences in pregnancy, spontaneous abortion, and clomifene resistance rates, the secondary outcome measures.

“The effects of metformin on ovulation may not be sufficiently strong to improve on the already high ovulation rates with clomifene citrate in these women,” the authors wrote.

Of the 111 women in the clomifene citrate plus metformin group, 64% ovulated. Of the 114 in the clomifene citrate plus placebo group, 72% ovulated. In the metformin group, 40% had an ongoing pregnancy, compared with 46% in the clomifene and placebo group. Spontaneous abortions occurred in 12% of the metformin group and 11% of the control group. None of these differences was statistically significant.

The authors note that their trial population was less obese than women evaluated in previous studies of the combined therapy, reflecting a normal range of women with polycystic ovary syndrome (PCOS)—around 35%–60% of such women are obese. Lean women are less likely to benefit from insulin sensitizers such as metformin because they are less insulin resistant.

Patients in the metformin group were significantly more likely to drop out of the study due to side effects, the authors said.

Clomifene citrate stimulates ovulation by increasing follicle-stimulating hormone and luteinizing hormone levels. Of women with PCOS treated with clomifene citrate, 75% will ovulate. Metformin, which potentiates insulin action, stimulates ovulation by reducing insulin and androgen levels.

Adding metformin to a clomifene citrate regimen did not significantly increase the probability of ovulating or becoming pregnant in women who had polycystic ovary disease and were treated with clomifene citrate alone.

This conclusion was based on results of a trial conducted at 20 Dutch hospitals where 228 women were randomized to receive either clomifene citrate (Clomid) in combination with metformin (Glucophage) or clomifene citrate with a placebo (BMJ 2006;doi:10.1136/bmj.38867. 631551.55). The researchers, led by Etelka Moll, registrar for obstetrics and gynecology at the center for reproductive medicine at Academic Medical Center, Amsterdam, found comparable ovulation rates in the two groups, the primary outcome measure, and no statistically significant differences in pregnancy, spontaneous abortion, and clomifene resistance rates, the secondary outcome measures.

“The effects of metformin on ovulation may not be sufficiently strong to improve on the already high ovulation rates with clomifene citrate in these women,” the authors wrote.

Of the 111 women in the clomifene citrate plus metformin group, 64% ovulated. Of the 114 in the clomifene citrate plus placebo group, 72% ovulated. In the metformin group, 40% had an ongoing pregnancy, compared with 46% in the clomifene and placebo group. Spontaneous abortions occurred in 12% of the metformin group and 11% of the control group. None of these differences was statistically significant.

The authors note that their trial population was less obese than women evaluated in previous studies of the combined therapy, reflecting a normal range of women with polycystic ovary syndrome (PCOS)—around 35%–60% of such women are obese. Lean women are less likely to benefit from insulin sensitizers such as metformin because they are less insulin resistant.

Patients in the metformin group were significantly more likely to drop out of the study due to side effects, the authors said.

Clomifene citrate stimulates ovulation by increasing follicle-stimulating hormone and luteinizing hormone levels. Of women with PCOS treated with clomifene citrate, 75% will ovulate. Metformin, which potentiates insulin action, stimulates ovulation by reducing insulin and androgen levels.

Adding metformin to a clomifene citrate regimen did not significantly increase the probability of ovulating or becoming pregnant in women who had polycystic ovary disease and were treated with clomifene citrate alone.

This conclusion was based on results of a trial conducted at 20 Dutch hospitals where 228 women were randomized to receive either clomifene citrate (Clomid) in combination with metformin (Glucophage) or clomifene citrate with a placebo (BMJ 2006;doi:10.1136/bmj.38867. 631551.55). The researchers, led by Etelka Moll, registrar for obstetrics and gynecology at the center for reproductive medicine at Academic Medical Center, Amsterdam, found comparable ovulation rates in the two groups, the primary outcome measure, and no statistically significant differences in pregnancy, spontaneous abortion, and clomifene resistance rates, the secondary outcome measures.

“The effects of metformin on ovulation may not be sufficiently strong to improve on the already high ovulation rates with clomifene citrate in these women,” the authors wrote.

Of the 111 women in the clomifene citrate plus metformin group, 64% ovulated. Of the 114 in the clomifene citrate plus placebo group, 72% ovulated. In the metformin group, 40% had an ongoing pregnancy, compared with 46% in the clomifene and placebo group. Spontaneous abortions occurred in 12% of the metformin group and 11% of the control group. None of these differences was statistically significant.

The authors note that their trial population was less obese than women evaluated in previous studies of the combined therapy, reflecting a normal range of women with polycystic ovary syndrome (PCOS)—around 35%–60% of such women are obese. Lean women are less likely to benefit from insulin sensitizers such as metformin because they are less insulin resistant.

Patients in the metformin group were significantly more likely to drop out of the study due to side effects, the authors said.

Clomifene citrate stimulates ovulation by increasing follicle-stimulating hormone and luteinizing hormone levels. Of women with PCOS treated with clomifene citrate, 75% will ovulate. Metformin, which potentiates insulin action, stimulates ovulation by reducing insulin and androgen levels.

GLASGOW, SCOTLAND — Soy products and dietary supplements containing a high level of flavonoids may be alternatives to chemoprevention of osteoporosis and prostate cancer, so long as consumption is moderated to limit the potential for side effects, investigators said at the 8th European Congress of Endocrinology.

Much of the evidence supporting the benefits of dietary soy comes from epidemiologic studies and analyses of disease patterns in Asians who change their diets after migrating to the West, according to Eva Lydeking-Olsen, a nurse practitioner and nutritionist with the Institute for Optimum Nutrition in Copenhagen.

When it comes to bone protection, epidemiologic studies and double-blinded placebo-controlled trials of soy lasting at least 6 months have shown mixed results. Four of 12 such studies have shown no benefits, as measured by dual-energy x-ray densitometry scans of bone mineral density (BMD), while eight have, said Ms. Lydeking-Olsen.

The eight showing a bone-protective effect focused on at-risk groups, so it was likely that continuing loss of bone mass in the control group affected the outcomes of the study, she said.

Consumption of 50–90 mg of isoflavones appears to have a beneficial effect, roughly the same as drinking two glasses of soy milk per day, she said.

“In the case of soy foods it is advisable to ask the manufacturer about the amount of isoflavones in specific brands of soy milk and soy yogurt, and also use foods such as natural, roasted soy flakes—on muesli, mixed in hot cereal or sprinkled over the salad—or soy nuts as a snack, as very little [isoflavone is] lost in those natural products,” she said in an interview.

Another expert, however, warned that the there is evidence that behavior of isoflavones could potentially have the same negative effects as estrogen, such as stimulating growth of uterine and breast tissues, leading to tumors.

“There is good evidence that lifelong intake of these isoflavones can be beneficial,” said Dr. Wolfgang Wuttke, professor of clinical and experimental endocrinology at the University of Göttingen. “But these are prepubertal effects.

“The evidence is so controversial that the [Food and Drug Administration] … would never allow sale of these substances as a drug,” said Dr. Wuttke “Why should I recommend substances which I am not sure are safe and might be useless?”

But when it comes to prostate cancer, Dr. Wuttke said that he believes there may be benefits for older men with increased isoflavone consumption.

Among the most studied of the isoflavones influencing prostate health is genistein, which may slow with the growth of prostate cells by influencing the hormone-metabolizing enzymes and reducing the sensitivity of the primary targets of androgen hormones such as the androgen receptor, said Dr. Helmut Klocker, a specialist in urology at Innsbruck (Austria) University Hospital.

Unlike with osteoporosis and soy, Dr. Klocker said there are no double-blinded placebo-controlled studies demonstrating the preventive effect of genistein.

“The problem with these [studies] is they would have to be performed over many years,” he said in an interview. “To my knowledge, it is not clear if there is a beneficial effect at any [specific] time in life. There is also some evidence that exposure to genistein and related substances is most efficient during growing up and puberty, and even during embryogenesis. You can imagine that it is almost impossible to investigate this in controlled trials.”

In a phase II trial sponsored by the National Cancer Institute, scientists are recruiting patients to test both the effectiveness and potential toxicity of genistein among men with stage I and stage II prostate cancer.

The trial plans to randomize 88 patients undergoing radical prostatectomy into two groups. One group will receive oral genistein once daily for 1–2 months, undergo the prostatectomy, and then continue the genistein regimen for 1–2 months afterward. The other group will undergo the prostatectomy first, and begin a 3-month genistein regimen 1 month after the surgery. The trial will test the reduction in prostate-specific angigen-positive cells in the operative field and quality of life at baseline and 1 and 3 months after surgery, Dr. Klocker said.

GLASGOW, SCOTLAND — Soy products and dietary supplements containing a high level of flavonoids may be alternatives to chemoprevention of osteoporosis and prostate cancer, so long as consumption is moderated to limit the potential for side effects, investigators said at the 8th European Congress of Endocrinology.

Much of the evidence supporting the benefits of dietary soy comes from epidemiologic studies and analyses of disease patterns in Asians who change their diets after migrating to the West, according to Eva Lydeking-Olsen, a nurse practitioner and nutritionist with the Institute for Optimum Nutrition in Copenhagen.

When it comes to bone protection, epidemiologic studies and double-blinded placebo-controlled trials of soy lasting at least 6 months have shown mixed results. Four of 12 such studies have shown no benefits, as measured by dual-energy x-ray densitometry scans of bone mineral density (BMD), while eight have, said Ms. Lydeking-Olsen.

The eight showing a bone-protective effect focused on at-risk groups, so it was likely that continuing loss of bone mass in the control group affected the outcomes of the study, she said.

Consumption of 50–90 mg of isoflavones appears to have a beneficial effect, roughly the same as drinking two glasses of soy milk per day, she said.

“In the case of soy foods it is advisable to ask the manufacturer about the amount of isoflavones in specific brands of soy milk and soy yogurt, and also use foods such as natural, roasted soy flakes—on muesli, mixed in hot cereal or sprinkled over the salad—or soy nuts as a snack, as very little [isoflavone is] lost in those natural products,” she said in an interview.

Another expert, however, warned that the there is evidence that behavior of isoflavones could potentially have the same negative effects as estrogen, such as stimulating growth of uterine and breast tissues, leading to tumors.

“There is good evidence that lifelong intake of these isoflavones can be beneficial,” said Dr. Wolfgang Wuttke, professor of clinical and experimental endocrinology at the University of Göttingen. “But these are prepubertal effects.

“The evidence is so controversial that the [Food and Drug Administration] … would never allow sale of these substances as a drug,” said Dr. Wuttke “Why should I recommend substances which I am not sure are safe and might be useless?”

But when it comes to prostate cancer, Dr. Wuttke said that he believes there may be benefits for older men with increased isoflavone consumption.

Among the most studied of the isoflavones influencing prostate health is genistein, which may slow with the growth of prostate cells by influencing the hormone-metabolizing enzymes and reducing the sensitivity of the primary targets of androgen hormones such as the androgen receptor, said Dr. Helmut Klocker, a specialist in urology at Innsbruck (Austria) University Hospital.

Unlike with osteoporosis and soy, Dr. Klocker said there are no double-blinded placebo-controlled studies demonstrating the preventive effect of genistein.

“The problem with these [studies] is they would have to be performed over many years,” he said in an interview. “To my knowledge, it is not clear if there is a beneficial effect at any [specific] time in life. There is also some evidence that exposure to genistein and related substances is most efficient during growing up and puberty, and even during embryogenesis. You can imagine that it is almost impossible to investigate this in controlled trials.”

In a phase II trial sponsored by the National Cancer Institute, scientists are recruiting patients to test both the effectiveness and potential toxicity of genistein among men with stage I and stage II prostate cancer.

The trial plans to randomize 88 patients undergoing radical prostatectomy into two groups. One group will receive oral genistein once daily for 1–2 months, undergo the prostatectomy, and then continue the genistein regimen for 1–2 months afterward. The other group will undergo the prostatectomy first, and begin a 3-month genistein regimen 1 month after the surgery. The trial will test the reduction in prostate-specific angigen-positive cells in the operative field and quality of life at baseline and 1 and 3 months after surgery, Dr. Klocker said.

GLASGOW, SCOTLAND — Soy products and dietary supplements containing a high level of flavonoids may be alternatives to chemoprevention of osteoporosis and prostate cancer, so long as consumption is moderated to limit the potential for side effects, investigators said at the 8th European Congress of Endocrinology.

Much of the evidence supporting the benefits of dietary soy comes from epidemiologic studies and analyses of disease patterns in Asians who change their diets after migrating to the West, according to Eva Lydeking-Olsen, a nurse practitioner and nutritionist with the Institute for Optimum Nutrition in Copenhagen.

When it comes to bone protection, epidemiologic studies and double-blinded placebo-controlled trials of soy lasting at least 6 months have shown mixed results. Four of 12 such studies have shown no benefits, as measured by dual-energy x-ray densitometry scans of bone mineral density (BMD), while eight have, said Ms. Lydeking-Olsen.

The eight showing a bone-protective effect focused on at-risk groups, so it was likely that continuing loss of bone mass in the control group affected the outcomes of the study, she said.

Consumption of 50–90 mg of isoflavones appears to have a beneficial effect, roughly the same as drinking two glasses of soy milk per day, she said.

“In the case of soy foods it is advisable to ask the manufacturer about the amount of isoflavones in specific brands of soy milk and soy yogurt, and also use foods such as natural, roasted soy flakes—on muesli, mixed in hot cereal or sprinkled over the salad—or soy nuts as a snack, as very little [isoflavone is] lost in those natural products,” she said in an interview.

Another expert, however, warned that the there is evidence that behavior of isoflavones could potentially have the same negative effects as estrogen, such as stimulating growth of uterine and breast tissues, leading to tumors.

“There is good evidence that lifelong intake of these isoflavones can be beneficial,” said Dr. Wolfgang Wuttke, professor of clinical and experimental endocrinology at the University of Göttingen. “But these are prepubertal effects.

“The evidence is so controversial that the [Food and Drug Administration] … would never allow sale of these substances as a drug,” said Dr. Wuttke “Why should I recommend substances which I am not sure are safe and might be useless?”

But when it comes to prostate cancer, Dr. Wuttke said that he believes there may be benefits for older men with increased isoflavone consumption.

Among the most studied of the isoflavones influencing prostate health is genistein, which may slow with the growth of prostate cells by influencing the hormone-metabolizing enzymes and reducing the sensitivity of the primary targets of androgen hormones such as the androgen receptor, said Dr. Helmut Klocker, a specialist in urology at Innsbruck (Austria) University Hospital.

Unlike with osteoporosis and soy, Dr. Klocker said there are no double-blinded placebo-controlled studies demonstrating the preventive effect of genistein.

“The problem with these [studies] is they would have to be performed over many years,” he said in an interview. “To my knowledge, it is not clear if there is a beneficial effect at any [specific] time in life. There is also some evidence that exposure to genistein and related substances is most efficient during growing up and puberty, and even during embryogenesis. You can imagine that it is almost impossible to investigate this in controlled trials.”

In a phase II trial sponsored by the National Cancer Institute, scientists are recruiting patients to test both the effectiveness and potential toxicity of genistein among men with stage I and stage II prostate cancer.

The trial plans to randomize 88 patients undergoing radical prostatectomy into two groups. One group will receive oral genistein once daily for 1–2 months, undergo the prostatectomy, and then continue the genistein regimen for 1–2 months afterward. The other group will undergo the prostatectomy first, and begin a 3-month genistein regimen 1 month after the surgery. The trial will test the reduction in prostate-specific angigen-positive cells in the operative field and quality of life at baseline and 1 and 3 months after surgery, Dr. Klocker said.