FDA Launches Pilot Program To Improve the Safety of Drugs and Active Drug Ingredients Produced Outside the United States

The U.S. Food and Drug Administration today announced the launch of a voluntary pilot program that would help promote the safety of drugs and active drug ingredients produced outside the United States.

The FDA plans to select 100 applicants to participate in the Secure Supply Chain pilot program. To qualify, applicants will need to meet the pilot program's criteria, including a requirement that they maintain control over the drug products from the time of manufacture through entry into the country.

The goal of the pilot is to allow FDA to determine the practicality of developing a secure supply chain program. Such a program would assist the agency in its efforts to prevent the importation of drugs that do not comply with applicable FDA requirements by allowing the agency to focus its resources on foreign-produced drugs that fall outside the program and that may not be compliant. It will also expedite the entry of products meeting the pilot's criteria into the United States. The pilot was developed with input from U.S. Customs and Border Protection and other stakeholders. Information about the pilot appears in a Federal Register notice that went on display today.

"This initiative creates incentives for drug makers to develop and maintain secure supply chains," said Deborah Autor, Director of the Office of Compliance in FDA's Center for Drug Evaluation and Research. "This is one of several agency initiatives to enhance drug product safety."

Each applicant may designate up to five drugs for selection in the pilot program. To qualify, applicants will need to meet the pilot's criteria, including a requirement that they maintain control over the drugs from the time of manufacture through entry into the United States. A secure supply chain will help mitigate risks such as contamination and counterfeiting. Applications for participation in the pilot program will be processed in the order received.

"With the increase of drug products produced outside the United States, it is critical that the FDA concentrate its resources on companies that pose the highest risk of importing products that don't meet the FDA's standards and violate U.S. laws," said Michael Chappell, acting Associate Commissioner for Regulatory Affairs at FDA. "Consumers should know that only companies that maintain control over their products will be selected into this pilot program."

Companies wishing to participate in the two year pilot program must meet certain criteria, including:

* For finished drug products, the applicant must hold an FDA-approved drug application or must be the foreign manufacturer identified in an FDA-approved application;
* The active pharmaceutical ingredients imported must be used only to make FDA‑approved drugs;
* Foreign drug manufacturers and U.S. establishments receiving drugs must be FDA-registered and comply with Good Manufacturing Practices; and
* Applicants must show that their drug products use a secure supply chain.

The pilot program is planned to run for a period of two years.

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Completely Predictable: Cholera in Zimbabwe

Zimbabwe’s cholera crisis, which has caused more than 1,900 deaths, is a “manmade disaster” caused by President Robert Mugabe’s government, according to a January 13 report by Physicians for Human Rights (PHR), co-authored by Johns Hopkins Bloomberg School of Public Health researcher Chris Beyrer, MD, MPH ’90.

The report, which presents qualitative data derived from interviews with health care workers, engineers, school teachers, NGO and UN representatives, and other officials in the country, attributes the epidemic to Mugabe’s intentional neglect of water treatment and sanitation services, which have fallen into severe disrepair since he was accused of electoral fraud and political violence during run-off elections this summer.

Beyrer, director of the Johns Hopkins Center for Public Health and Human Rights, gathered data in Zimbabwe with three other PHR physicians during a covert five-day visit to the country in mid-December. Escorted by a group of Zimbabwean doctors, Beyrer and colleagues, in-country on tourist visas, toured four provinces, in both rural and urban locations. The general hospitals were “bolted closed,” said Beyrer, the cholera hospitals were under tight surveillance, and the mission hospitals were stretched beyond the point of being able to deliver medical supplies or even running water.

“Zimbabwe offers a classic lesson in public health,” said Beyrer. “When government neglects its basic functions, citizens die. The cholera epidemic in Zimbabwe is completely predictable and preventable. It’s the outcome of the collapse of the most basic water and sanitation measures.”

The health care infrastructure in Zimbabwe has been deteriorating since 2000, when Mugabe began a “land reform” program that undermined the nation’s agriculture industry and crippled the economy. After the disputed polls this summer and a UN order to share power with his political rival in September, Mugabe became proactive in his punishment of Zimbabweans. According to Beyrer, professor of Epidemiology, Mugabe created an extreme breakdown of the health care system.

“You can’t mistake the stench of the sewage,” said Beyrer. In all provinces visited, he and his colleagues observed ruptured sewage pipes and garbage that lines the dirt roads alongside ditches. “There’s open sewage,” said Beyrer. “In some towns, citizens have built walls of garbage—the garbage hasn’t been collected in months.”

The outlook for cholera in the country is grim. The monsoon rains are just beginning in Zimbabwe now, after five months of a cholera crisis, and Beyrer expects the epidemic to worsen.

As a stopgap measure, said Beyrer, aid groups can provide medicine and food. But the crisis may intensify to a degree that the international community would intervene in Zimbabwe against Mugabe’s wishes, acting on a controversial concept known as Responsibility to Protect (a UN-endorsed concept that obligates the international community to respect, protect and fulfill nations’ rights to sovereignty).

A telling footnote to the cholera story, said Beyrer, is the prevalence they observed, among Zimbabweans, of pellagra, a vitamin deficiency disease precipitated by a carbohydrates-only diet. Health officials in Zimbabwe are not allowed to report malnutrition, because no one is supposed to be starving in Zimbabwe, the nation formerly known as “the breadbasket of the world.”

“All of this is evidence of why good government is so central to public health,” said Beyrer. “The basic functions of public health really are state functions. When a state ceases in that, public health fails.” — Christine Grillo

Read In Zimbabwe, a Cancer Called Mugabe, by Chris Beyrer and Frank Donaghue, in the Washington Post.

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Annual CDC Report Finds High Burden of Sexually Transmitted Diseases, Especially Among Women and Racial Minorities

Reported cases of chlamydia and gonorrhea in the United States exceeded 1.4 million in 2007, according to an annual report (http://www.cdc.gov/std/stats07/) by the Centers for Disease Control and Prevention. These diseases continue to be the most commonly reported infectious diseases in the nation and pose persistent and preventable threats to fertility in the United States.

The report, Sexually Transmitted Disease Surveillance, 2007, shows persistent racial disparities across these and other sexually transmitted diseases (STD), and a particularly heavy burden of disease among women. The report also finds continued increases in syphilis. This disease, while once on the verge of elimination, began re-emerging as a threat in 2001 and increased 15.2 percent between 2006 and 2007.

"The widespread occurrence of these diseases should serve as a stark reminder that STDs remain a serious health threat in the United States, especially for women and racial and ethnic minorities," said John M. Douglas, Jr., M.D., director of CDC's Division of STD Prevention. "Left untreated, chlamydia and gonorrhea can cause infertility, affecting a woman's chance to bear children later in life. Such a severe consequence is entirely avoidable, if as a nation we work together to increase the use of proven prevention tools and make them widely available to those who need them."

Women Bear Heavy STD Burden, Including Risk of Infertility

Women continue to bear a disproportionate burden of the long-term health consequences of STDs. In 2007, the chlamydia rate among women was three times that of men (543.6 cases per 100,000 women, compared to 190 cases per 100,000 men). The gonorrhea rate was also higher among women (123.5 per 100,000 women, compared to 113.7 per 100,000 among men).

Although the two diseases can be easily diagnosed and treated, they often have no symptoms and go undetected. If left untreated, up to 40 percent of chlamydia and gonorrhea infections in women can result in pelvic inflammatory disease -- a condition that causes as many as 50,000 women to become infertile each year. Untreated chlamydia or gonorrhea can also cause ectopic pregnancy, chronic pelvic pain, and other serious health problems.

The report found that there were more than 1.1 million chlamydia cases reported in 2007, up from about one million in 2006, making it the largest number of cases ever reported to CDC for any condition. Gonorrhea, the second most commonly reported infectious disease, had more than 350,000 cases reported in 2007. However, it is estimated that more than half of all new infections with chlamydia and gonorrhea continue to go undiagnosed, underscoring the importance of increased screening. CDC recommends annual chlamydia screening for all sexually active women under 26 years old, and supports U.S. Preventive Services Task Force recommendations to screen high-risk, sexually active women for gonorrhea.

STDs Take Heaviest Toll on Racial Minorities, Especially Black Women

CDC's 2007 STD surveillance report also indicates ongoing racial disparities in the three most common reportable STDs, with African-Americans bearing the greatest burden. While representing 12 percent of the U.S. population, blacks had about 70 percent of reported gonorrhea cases and almost half of all chlamydia and syphilis cases (48 percent and 46 percent respectively) in 2007.

STDs take an especially heavy toll on black women 15 to 19 years of age, who account for the highest rates of both chlamydia (9,646.7 per 100,000 population) and gonorrhea (2,955.7 per 100,000 population) of any group. STDs in this age group are of particular concern because of the potential threat of these two diseases to a woman's fertility.

Studies have shown that one of the most important social determinants of sexual health is socioeconomic status. Higher rates of poverty among blacks than whites, and socioeconomic barriers to quality healthcare and STD prevention and treatment services have been associated with higher prevalence and incidence of STDs among racial and ethnic minorities.

"The racial disparities in rates of STDs are among the worst health disparities in the nation for any health condition," stressed Douglas. "We must intensify efforts to reach these communities with needed screening and treatment services. Testing and the knowledge of infection is a critical first step toward reducing the continued consequences of these diseases."

Growing Threat of Syphilis

Syphilis, a disease close to being eliminated as a public health threat less than a decade ago, has increased each year since 2000 and remains a serious threat to the health of gay and bisexual men.

In 2007, men who have sex with men (MSM) continued to account for the majority of primary and secondary (P&S) syphilis cases, representing 65 percent of the 11,466 P&S syphilis cases reported. Increased transmission among MSM is believed to be the primary driver of increased rates of syphilis overall in the United States. Syphilis among MSM is of particular concern because it can facilitate HIV transmission and lead to irreversible complications such as strokes, especially in those who already have HIV. CDC recommends that all MSM be tested for syphilis at least annually.

Additionally, while P&S syphilis continues to occur at substantially lower levels among women than men (1.1 cases per 100,000 among females compared to 6.6 among males), syphilis rates have been increasing among women and infants in recent years, reversing years of decline in these populations. Syphilis rates among women have increased since 2004, and the rate of congenital syphilis increased for the second consecutive year in 2007. Because untreated syphilis can be transmitted from a pregnant woman to her infant and result in stillbirths, infant deaths, or severe complications in children who survive, CDC recommends that all women be screened for syphilis during the early stages of pregnancy.

Intensified Efforts Needed to Address Significant Gaps in STD Prevention

To reduce the toll of STDs and protect the health of millions of Americans, expanded prevention efforts are urgently needed. CDC estimates that almost 19 million new sexually transmitted infections occur each year, and almost half of those are among 15- to 24-year-olds. In addition to the threat of infertility, increased risk of HIV acquisition, and other health risks, STDs also have a substantial economic impact. CDC estimates STDs cost the U.S. health care system as much as $15.3 billion annually.

CDC supports a comprehensive approach to STD prevention through screening, treatment, and behavioral interventions, with a focus on reducing health disparities, especially those occurring among racial and ethnic groups. To further progress against the most widespread reportable STDs, CDC, along with the Partnership for Prevention and eight other leading STD organizations, recently established the National Chlamydia Coalition. CDC also has been working with partners and community leaders across the nation on syphilis elimination efforts since 1999, yet successes in some areas and populations continue to be offset by increases in others, as programs must continually shift efforts to address emerging needs. Ultimately, successful elimination of this disease will require intensified efforts at the federal, state and local level to reach the diverse and expanded populations now at risk.

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Mike Robertson Named CEO of Piedmont Mountainside Hospital

After serving as interim CEO since July 2008, Mike Robertson has been named president and chief executive officer of Piedmont Mountainside Hospital.

Previously, Robertson was vice president of operations for Piedmont Mountainside, overseeing clinical and support services. He joined Piedmont Mountainside in July 2002 as manager of respiratory care. He also assisted with performance improvement and was promoted to vice president of operations in March 2006.

“Mike has been an effective leader, and we are excited about his permanent role as CEO,” said Gregory A. Hurst, chairman of the board of Piedmont Mountainside Hospital and executive vice president/COO for Piedmont Healthcare. “His healthcare experience, years at Piedmont Mountainside and dedication to the community make him a valuable member of our team and a tremendous asset to those we serve.”

Under Robertson’s leadership, Piedmont Mountainside recently completed a $7 million construction project which included expanding the ICU, laboratory, cafeteria and lobby; adding six new beds for the clinical decision unit; and renovations to accommodate other support services. In addition, the MRI unit was established in a permanent in-house location, and a new interventional radiology suite was added.

A Georgia native, Robertson earned his bachelor’s degree in respiratory therapy from the Medical College of Georgia and a master’s of business administration from Shorter College in Rome. He is a member of the American College of Healthcare Executives and the Georgia Association of Healthcare Executives. Mike and his wife, Georgette, live in Ball Ground with their two children, Taylor and Will.

Robertson took the helm at Piedmont Mountainside when former president and CEO Ed Lovern was named executive vice president and chief administrative officer for Piedmont Healthcare.
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CDC Statement on Oseltamivir (Tamiflu®) Resistance and Antiviral Recommendations

On December 19, 2008, CDC issued interim guidance for health care professionals on the use of influenza antiviral medications this flu season. The guidance was issued in response to early data from a limited number of states indicating that a high proportion of influenza A (H1N1) viruses are resistant to the influenza antiviral medication oseltamivir (Tamiflu®). Worldwide, the proportion of H1N1 viruses that are resistant to oseltamivir has been increasing so this development is not surprising.

Recent media reports may have led some to believe that these developments mean physicians are without influenza treatment options for the 2008-2009 flu season.

At this time, it’s not possible to predict how common H1N1 viruses will be during the rest of this flu season, as there are many different flu viruses and every influenza season is different. The current samples studied come from a handful of states, and may not be indicative of how the rest of the season will progress or what viruses will circulate in other states. However the circulation of oseltamivir-resistant viruses does have treatment implications for health care professionals. CDC is continuing to monitor this situation very closely, but has issued interim guidance for health care professionals to guide their treatment decisions in the current situation.

In fact, the interim CDC guidance provides advice for clinicians on how to treat patients with influenza antiviral medications this season. Clinicians can use influenza test results and information, if available, about which viruses are circulating, to help decide which antiviral(s) should be used. If H1N1 viruses are circulating in the community, or it’s not clear which viruses are circulating, health care providers are recommended to use an alternative antiviral, zanamivir (Relenza®), or to use combination therapy of oseltamivir and rimantadine. Use of zanamivir or dual therapy with oseltamivir and rimantadine would provide effective treatment against all circulating influenza viruses. In some instances, oseltamivir alone can still be used, such as when influenza B is diagnosed, or H1N1 viruses are not circulating.

It is important to remember that CDC recommends annual influenza vaccination as the first and best step in preventing the flu. It is not too late to get vaccinated and this year′s influenza vaccine is expected to be effective against currently circulating oseltamivir-resistant influenza A (H1N1) viruses.

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Study: Fluoridation Benefits Doubtful

/PRNewswire-USNewswire/ -- Achieving cavity-free status has little to do with fluoride intake, reports a study in the Fall 2008 Journal of Public Health Dentistry.

The ongoing Iowa Fluoride Study (IFS), begun in 1992, follows a cohort of children from birth. Researchers measure fluoride use and ingestion, count cavities and document fluorosis - white spotted, yellow and/or brown stained teeth - the outward sign of fluoride over-ingestion.

IFS researchers report, "The benefits of fluoride are mostly topical...while fluorosis is clearly more dependent on fluoride intake."

They explain that when fluoridation began in the 1940's, "it was believed that fluoride needed to be ingested early in life to provide [cavity] prevention...Today, evidence suggests that...the benefits of fluoride are mostly topical."

Fluoride chemicals are added to 70% of public water supplies at so-called "optimal" levels (0.7 parts per million - 1.2 ppm), once believed to prevent cavities.

The IFS researchers find that "firmly recommending an 'optimal' fluoride intake is problematic." They agree with fluoride researchers Burt and Eklund that the term "optimal fluoride intake" be dropped from common usage.

Quantifying fluoride intake is more complex than it was several decades ago because of the widespread use of fluoridated dental products and increased fluoride content of foods, they report.

"Thus, it is doubtful that parents or clinicians could adequately track children's fluoride intake and compare it with the recommended level, rendering the concept of an "optimal" or target intake relatively moot," they write.

In 2003, IFS researchers wrote, "There is no specific nutritional requirement for fluoride." They described the fluoride content of some foods. For example:

-- Processed chicken: 4.4 ppm and 10.0 ppm fluoride
-- Cereals: 3.8 to 6.3 ppm
-- Creamed spinach: 2 ppm
-- Soft drinks: up to 1.55 ppm
-- Decaffeinated tea: 3.19 ppm
-- White grape juice: 4 ppm
-- Ready-to-feed infant formula: from 0.15 to 0.30 ppm


"This well-done, long-term study by respected fluoride researchers, and published piecemeal in several scientific journals, tells us that fluoride ingestion, such as fluoridated water and supplements, is causing dental defects with little, if any, benefit," says attorney Paul Beeber, President, New York State Coalition Opposed to Fluoridation, Inc.

"Thus, fluoridation damages teeth, wastes money and must be stopped," says Beeber.

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Why Bladder Cancer Is Deadlier for Some

/PRNewswire-USNewswire/ -- Bladder cancer is much more likely to be deadly for women and African-Americans, but the reasons long believed to explain the phenomenon account for only part of the differences for such patients compared to their white and male counterparts, according to results published in the Jan. 1 issue of the journal Cancer.

The results present a stark question for doctors and patients: If age, tumor type, and stage of the disease upon diagnosis don't account for all the increased lethality of the disease in women and African-Americans, then what does?

It's a gaping question facing researchers who have long confronted an irony of bladder cancer, the fifth-most-common type of cancer in America. The disease is more lethal in those patients who are less likely to get it.

Men are more than three times as likely as women to get the disease, and white people are nearly twice as likely to get the disease as African-Americans. Yet, once the disease is present, it's far deadlier in women and in African-Americans -- anywhere from 73 percent to 114 percent more deadly in the first year after diagnosis, depending on the group.

In the Cancer paper, scientists and physicians at the University of Rochester Medical Center show for the first time that the factors traditionally thought to be responsible for the differing course are responsible for only about one-third of the difference between white men and women, and up to two-thirds of the difference between African-Americans and their white counterparts.

"We've known that the disease is likely to be more advanced in women and African-Americans by the time they're diagnosed," said corresponding author Edward Messing, M.D., a surgeon well known for his expertise in treating patients with bladder cancer. "Like many doctors, I long assumed that the delay in diagnosis was the reason why the disease is more deadly for these patients.

"I was surprised to find that recognized factors like a delay in diagnosis explain only part of the difference. There are clearly other important factors at work that make these patients more likely to die from the disease. There could be something different about the cancer itself, or there could be differences in the ways these groups are treated," said Messing, who is professor of Urology and Oncology as well as leader of the Prostate Cancer and Genitourinary Oncology team at the James P. Wilmot Cancer Center.

To do the study, scientists analyzed the records of more than 100,000 patients who were diagnosed with bladder cancer from 1990 to 2003. Their records are part of a national cancer registry known as SEER (Surveillance, Epidemiology, and End Results). The 101,249 patients came from 16 different regions: Atlanta, rural Georgia, Connecticut, Detroit, Seattle, Hawaii, Iowa, New Mexico, San Francisco, Los Angeles, San Jose, rural California, Kentucky, Louisiana, New Jersey, and Utah.

The statistical analysis was done by first author Emil Scosyrev, a graduate student in epidemiology; Katia Noyes, Ph.D., associate professor of Community and Preventive Medicine; and Changyong Feng, Ph.D., assistant professor of Computational Biology and Biostatistics. The work was funded by the Ashley Family Foundation.

The team found that in the first year after diagnosis, women were anywhere from about 80 percent to 114 percent more likely to die from the disease than their male counterparts. That increase was a bit lower in year two, when women were about 52 to 55 percent more likely to die.

When it came to race, the researchers found that African-Americans were about 73 percent to 103 percent more likely than their white counterparts to die from the disease within the first two years after diagnosis, and about 40 percent to 117 percent more likely to die three or four years after diagnosis.

Then the team sifted through the data to try to uncover the reasons behind these differences. The team found that the factors traditionally thought to be responsible for the differences -- stage of the disease upon diagnosis, tumor type, and age -- accounted for only about 30 percent of the difference between the genders among white people, and about 50 to 70 percent of the differences between the races and between the genders among African-Americans.

"The current study by Scosyrev et al elegantly demonstrates that, even after controlling for tumor characteristics, inferior outcomes remain for African-American patients and women," write physicians Mark Katz, M.D., and Gary Steinberg, M.D., of the University of Chicago Medical Center in an editorial accompanying the findings.

The authors speculate about other factors that might be responsible for the differences, though they say that further study is necessary to know for sure. Some of the other issues that might play a role include the choice of treatment chosen, differences among tumors that were not taken into account in the study, and access to health care.

Messing believes that poorer access to health care is a clear cause of the higher mortality rates for African-Americans. He says African-American patients and their doctors need to be aware of the increased chance of death for these patients, who should be treated as aggressively as possible.

When it comes to gender, some of the differences are likely caused by factors that are not currently understood, such as hormonal differences, says Messing. But a factor that is known to play a key role is people's reaction when they see blood in their urine. Men are more likely than women to notice blood in their urine, to think it's abnormal, and to report it to doctors -- and even then, when it is reported, doctors are 65 percent more likely to refer men than women to urologists.

The authors say that women who find blood in their urine need to be vigilant about having the cause checked as quickly as possible. In women with bladder cancer, sometimes treatment is delayed while doctors investigate other potential causes of blood in the urine. While that is often a sign of a urinary tract infection or something other than cancer, Messing says it's crucial for doctors to consider bladder cancer as a potential cause right from the start.

"People need to be especially vigilant about blood in the urine," said Messing. "Be sure to report it to your doctor, and be sure the doctor investigates the cause thoroughly."

The American Cancer Society estimates that in 2007, 67,000 people in the United States were newly diagnosed with bladder cancer, and 13,700 patients died of the disease.

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Preterm Births Rise 36 Percent Since Early 1980s

/PRNewswire-USNewswire/ -- New government statistics confirm that the decades-long rise in the United States preterm birth rate continues, putting more infants than ever at increased risk of death and disability according to the March of Dimes.

Nearly 543,000 babies were born too soon in 2006, according to the National Center for Health Statistics, which today released "Births: Final data for 2006," National Vital Statistics Reports; Vol. 57, No. 7. The nation's preterm birth rate (birth before 37 completed weeks gestation) rose to 12.8 percent in 2006 -- that's a 36 percent increase since the early 1980s.

The report attributed much of the increase to the growing number of late preterm infants (those born at 34 to 36 weeks gestation), which increased 25 percent since 1990. The report also noted an increase in preterm births to Hispanic women, while rates were unchanged for non-Hispanic whites and blacks. However, black women continue to have the highest preterm birth rate, at 18.5 percent.

The preterm birth rate continued to rise despite the fact that multiple births, a known risk factor for preterm birth, have begun to stabilize. The rate of twin births was unchanged in 2005 and 2006, and triplets and higher order multiples declined 5 percent in 2006.

"The health consequences for babies who survive an early birth can be devastating and we know that preterm birth exacts a toll on the entire family -- emotionally and financially," said Dr. Jennifer L. Howse, president of the March of Dimes.

"We've are committed to raising public awareness about premature birth, and we believe there are concrete steps we can take to solve this problem, including ensuring that all women of childbearing age have access to health insurance and expanding our nation's investment in research into the causes and strategies to prevent preterm birth" Dr. Howse continued.

Preterm birth is the leading cause of death in the first month of life and a contributing cause in more than a third of all infant deaths. Babies who survive an early birth face the risk of serious lifelong health problems and even late preterm infants have a greater risk of breathing problems, feeding difficulties, temperature instability (hypothermia), jaundice, delayed brain development and an increased risk of cerebral palsy and mental retardation.

Last month, the March of Dimes issued its first-ever Premature Birth Report Card, which gave the United States a "D" -- and not a single "A" to any state -- by comparing 2005 preterm birth rates to the national Healthy People 2010 objective of 7.6 percent. The report card is online at www.marchofdimes.com/petition.

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Georgia State Study First to Pinpoint Why Analgesic Drugs May be Less Potent in Females than in Males

Investigators at Georgia State University’s Neuroscience Institute and Center for Behavioral Neuroscience are the first to identify the most likely reason analgesic drug treatment is usually less potent in females than males. This discovery is a major step toward finding more effective treatments for females suffering from persistent pain.

“Opioid-based narcotics (such as morphine) are the most widely prescribed therapeutic agents for the alleviation of persistent pain; however, it is becoming increasingly clear that morphine is significantly less potent in women compared with men. Until now, the mechanism driving the phenomenon was unknown,” said Anne Murphy, a Georgia State Professor of Neuroscience and member of the Center for Behavioral Neuroscience, who conducted the research with Dayna Loyd.

Murphy recently solved the mystery with findings printed in the December issue of The Journal of Neuroscience that show that previously reported differences in morphine’s ability to block pain in male versus female rats are most likely due to sex differences in mu-opioid receptor expression in a region of the brain called the periaqueductal gray area (PAG).

Located in the midbrain area, the PAG plays a major role in the modulation of pain by housing a large population of mu-opioid receptor expressing neurons. Morphine and similar drugs bind to these mu-opioid receptors analogous to a ‘lock and key’ and, ultimately, tell the brain to stop responding to pain signals to the nerve cells resulting in the reduced sensation of pain.

Using a series of anatomical and behavioral tests, Murphy and Loyd were able to determine that male rats have a significantly higher level of mu-opioid receptors in the PAG region of the brain compared with females. This higher level of receptors is what makes morphine more potent in males because less drug is required to activate enough receptors to reduce the experience of pain. Interestingly, when they used a plant-derived toxin to remove the mu-opioid receptor from the PAG, morphine no longer worked, suggesting that this brain region is required for opiate-mediated pain relief.

Additional tests also found females reacted differently to morphine depending on the stage of their estrous cycle. These findings indicate that steroid hormones may affect mu-opioid receptor levels in the region of the PAG that are essential for analgesia and also suggest that the actions of morphine are estrous stage-dependent.

“Interestingly, sex is not the only factor that has been shown to affect the potency of various pharmacological agents. Recent studies have reported an influence of age and ethnicity, and further argue for the inclusion of a wide range of study subjects in pain management research,” Murphy said. “In addition, despite the rapidly mounting evidence regarding the limitations of opiates in treating persistent pain, opioid-based drugs remain the primary pharmacological tool for pain management. Clearly additional research with the inclusion of female subjects needs to be devoted to determining a more potent treatment for persistent pain in women.”

Murphy’s work was supported by grants from the National Institutes of Health.

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Mayo Researchers Offer New Insight into Effectiveness of Procedure to Stop Heavy Menstrual Bleeding

Experts estimate that 20 percent of women experience excessive or prolonged menstrual bleeding at some time during their lives, particularly as they approach menopause. A new, less invasive procedure called global endometrial ablation (GEA) preserves the uterus, while decreasing menstrual bleeding and shortening patients' recovery time. In an article published in the January issue of Obstetrics and Gynecology, Mayo Clinic researchers attempt to determine the percentage of women who do not achieve permanent symptom relief from GEA and identify several factors that put women at greater risk for this outcome.

For decades, hormone pills or hysterectomy, surgical removal of the uterus, were the standard treatments for excessive or prolonged menstrual bleeding. Although numerous studies have established the safety of GEA, some women who undergo this procedure require additional treatment or hysterectomy later because significant menstrual pain or heavy bleeding symptoms resume.

How GEA works

During this procedure, surgeons use an energy source (heat, cold and microwave or radiofrequency energy) to destroy just the uterine lining (endometrium) and leave the uterus intact. Once the cells or the tissue that line the uterus are destroyed, scar tissue forms, and monthly menstrual flow and any accompanying pain typically decrease.

Research focus

Compared to hysterectomy, the newest forms of GEA were initially thought to be equally effective with slightly lower complication rates and costs.

"We've known for the past five to six years that global endometrial ablation devices are very effective," says Mayo Clinic gynecologic surgeon Abimbola Famuyide, M.B.B.S., one of the study's authors. "But some physicians have observed that up to 30 percent of patients may require additional treatment five years and beyond after undergoing ablation."

Undergoing a hysterectomy or another treatment following ablation to achieve permanent symptom relief can be costly and inconvenient for patients. Mayo researchers note that much of the medical research citing failure rates associated with GEA had relatively small study populations and differing definitions of what constituted failure. To establish more precise, population-derived data measuring how many women do not experience permanent symptom relief following GEA, they studied the medical records of approximately 816 women who underwent ablation from Jan. 1, 1998, through Dec. 31, 2005.

"We found that only 16 percent of our subjects required hysterectomy to treat excessive bleeding five years after ablation. That is nearly half of what has generally been reported in the literature to date," explains Dr. Famuyide.

Mayo researchers hypothesized that the low failure rate they observed might mean that their study patients received counseling about realistic expectations for symptom relief. "For example, patients who are seeking complete cessation of menstrual bleeding after GEA are more likely to undergo hysterectomy later to treat bleeding symptoms of any severity," says Dr. Famuyide.

Mayo Clinic research data also showed that patients under age 45, patients who have undergone tubal ligation (a procedure to prevent pregnancy), and patients who experienced debilitating menstrual pain before undergoing GEA were less likely to experience permanent symptom relief following ablation.

According to the Mayo researchers, identifying risk factors that affect treatment outcomes following GEA is an important advance in this field. This knowledge can help surgeons determine whether GEA is appropriate for a specific patient and help them provide patients with better guidance when choosing a treatment option, say researchers.

"Optimizing preoperative patient counseling and patient selection could allow failure rates associated with GEA to decrease," explains Dr. Famuyide.
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Biological Link Connects Childhood Trauma and Risk for Chronic Fatigue Syndrome

Childhood trauma is a potent risk factor for development of chronic fatigue syndrome (CFS), according to a study by researchers at Emory University School of Medicine and the Centers for Disease Control and Prevention (CDC). The study is published in the Jan. 5, 2009 Archives of General Psychiatry.

Results of the study confirm that childhood trauma, particularly emotional maltreatment and sexual abuse, is associated with a six-fold increased risk for CFS. The risk further increases with the presence of posttraumatic stress disorder symptoms.

The study also found that low levels of cortisol, a hallmark biological feature of CFS, are associated with childhood trauma. Cortisol is frequently referred to as the “stress hormone" and is important to regulate the body’s response to stress. A lack of cortisol’s effects may cause altered or prolonged stress responses.

“The study indicates that low cortisol levels may actually reflect a marker for the risk of developing CFS rather than being a sign of the syndrome itself,” said Christine M. Heim, PhD, lead author of the study and associate professor in the Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine.

The population-based study analyzed data from 113 people with CFS, and a control group of 124 people without CFS, drawn from a sample of almost 20,000 Georgians. The results confirm earlier findings from a 2006 study conducted in Wichita, Kan.

Study participants completed a self-reported questionnaire on five different types of childhood trauma including emotional, physical and sexual abuse, and emotional and physical neglect. Researchers also collected saliva samples from participants to record levels of cortisol over one hour after awakening, typically an individual's highest cortisol levels for the day.

"When looking at CFS cases with and without histories of childhood trauma, only those with childhood trauma had the classic low cortisol levels often seen in CFS cases," explains Heim.

"It is important to emphasize that not all patients with CFS have been through childhood trauma,” she says. “CFS may be part of a spectrum of disorders associated with childhood adversity, which includes depression and anxiety disorders."

Certain experiences children have while the brain is developing and vulnerable can make a difference in the way the body reacts to stress later in life, and may have long-term health consequences.

“Trauma that occurs at different times in childhood may be linked to different long term changes. It’s an area in which more work is needed," says Heim.

This study was supported by a grant from the Centers for Disease Control and Prevention.

Reference: Childhood Trauma and Risk for Chronic Fatigue Syndrome: Association with Neuroendocrine Dysfunction, Archives of General Psychiatry 2009; Vol. 66 (1): 72-80
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Flu Season is Tea Time

/PRNewswire/ -- January is National Hot Tea Month and is also the height of the dreaded "cold and flu season". The CDC estimates that there will be more than 200,000 Americans affected by the cold and flu this year, which leads to missing work, school and even social gatherings. So what can one do to avoid the cold and flu?

The CDC strongly recommends an annual flu vaccine as the best way to reduce the chances that you will get the flu. In addition, drinking hot tea may also help you stay healthy during the cold and flu season.

Published research from Brigham and Women's Hospital and Harvard University indicates that theanine, an ingredient found naturally in tea, supports the immune system. A cup of tea contains an average of 20-25 mg of theanine. Drinking tea throughout the day may strengthen the immune system which is something important to do during the cold and flu season.

Drinking five cups of Black Tea a day for two to four weeks boosted the body's immune defense system by four times, according to the results of a human clinical trial. According to this study, the data suggests that drinking Black Tea boost's the body's natural resistance to infection.(1)

Tea also contains flavonoids, which are naturally occurring compounds known for their antioxidant properties. Antioxidants work to neutralize free radicals, which scientists believe damage elements in the body, such as genetic material and lipids, and contribute to many chronic diseases.

The CDC states that healthy adults have a 30% chance of contracting the flu even with an annual flu vaccination, and the vaccine may be somewhat less effective for children and the elderly. And while drinking tea may not keep you from getting sick this season, it can help your odds of staying healthy.

So why not do something good for your body while having a hot beverage ... help stay healthy this cold and flu season and drink your tea every day! For more information about the role of tea in a healthy diet and lifestyle, please visit www.TeaUSA.org.

(1) Kamath AB, Wang L, Das H, Li L, Reinhold VN, Bukowski JF. Antigens in tea-beverage prime human Vgamma 2Vdelta 2 T cells in vitro and in vivo for memory and nonmemory antibacterial cytokine responses. Proc Natl Acad Sci U S A. 2003 May 13;100(10):6009-14. Epub 2003 Apr 28.

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FDA Announces Class I Recall of Ophthalmic Surgical Device

The U.S. Food and Drug Administration announced a Class I recall of lot no. UD30654 of Healon D, an ophthalmic viscosurgical device (OVD) manufactured by Advanced Medical Optics Inc. (AMO) of Santa Ana, Calif.

OVDs are viscoelastic materials used to maintain space in the eye during surgery. Typically, OVDs are pre-packaged in a syringe and are applied using a small tube.

On Oct. 30, 2008, AMO voluntarily recalled all 4,439 units of Healon D lot no. UD30654 of Healon D, due to complaints of inflammation after eye surgery, including Toxic Anterior Segment Syndrome (TASS). At that time, AMO informed customers of the number and nature of adverse event reports associated with OVD from that lot, and included a fax reply form for quick communication.

However, as of December 3, 2008, AMO had retrieved only 964 units of the 1,450 that had been distributed in the United States.

AMO received 66 adverse event reports associated with the recalled products. Tests of this lot revealed elevated levels of endotoxin, which has been associated with post-operative intraocular inflammation and TASS.

TASS is a post-operative, acute inflammation of the anterior segment of the eye (the front third of the eye including the cornea, iris and lens). TASS has been linked to solutions and devices used during eye surgery, such as OVDs, intraocular lenses and irrigation solutions.

The FDA urges anyone in possession of any units from the recalled lot, whether units were purchased from the company or provided as a sample by a sales representative, to remove them from inventory, and contact AMO at 1-877-AMO-4Life to make arrangements for return. The lot number of the device is displayed on the side panel of each unit.

Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to AMO by calling 1-877-AMO-4LIFE and to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

Online: www.fda.gov/MedWatch/report.htm
Regular Mail: use postage-paid FDA form 3500 available at www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD, 20852-9787
Fax: (800) FDA-0178
Phone: (800) FDA-1088

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Future Airman Loses 160 Pounds, Gains Confidence

For the past 15 months, Leo Knight-Inglesby has pushed himself beyond the limits he and his loved ones ever thought possible.

The 22-year-old Silver Spring, Md., native shed more than 160 pounds to meet the physical standard of Air Force enlistment, amazing his recruiter, family and friends.

"No one believed I would do it till I showed them the [enlistment] papers," Knight-Inglesby said. "My life has completely changed. Not only am I stronger, physically, I am mentally stronger and more confident."

Today, the former 351-pound college freshman noshes only on healthy food, limits his daily caloric intake and exercises at least five days a week. Although he maintains the same smile, he looks like a different person at about 190 pounds, his recruiter, Air Force Staff Sgt. Ty Lopez, said.

"He's well on his way to making his goal of 185 pounds before heading to basic military training," Lopez said.

Knight-Inglesby is scheduled to enter basic training at Lackland Air Force Base, Texas, in March, but said he hopes to attend earlier if a spot becomes available.

The 317th Recruiting Squadron recruiter caught Knight-Inglesby's attention in the summer of 2007 while speaking about Air Force opportunities to a group of people near a local community college.

"I wasn't getting much interest out of anyone except an obviously overweight guy in the back of the group," Lopez recalled. "He asked me questions that I gladly answered in hopes that the other guys in the group would become interested. At the end of our conversation, Leo said he wanted to join."

The recruiter told the young man he looked heavier than the maximum allowable weight to enlist, and that at his height he needed to weigh under 202 pounds to join. A week later, Knight-Inglesby visited Lopez, tipping the recruiting office scale at 347 pounds and leading the future airman to a serious evaluation of his life.

"My uncle was overweight and had a massive heart attack, and I didn't want that to happen to me" he said. "I knew I had to get my life on track, and I wanted the benefits the Air Force offers."

The potential to travel overseas, especially to Germany, remains a powerful motivator for Knight-Inglesby, as does his father's encouragement to serve in the military. Both his grandfathers and father served in the Army, and his brother serves in the Navy.

The only issue that kept Knight-Inglesby from becoming an airman earlier was his girth, he said.

Lopez said Knight-Inglesby's weight loss gave him insight on the power of personal determination. When Knight-Inglesby proved he was serious about making the standard, Lopez joined him at the gym and helped the future airman continue when he reached a plateau in his weight loss at 220 pounds.

"We worked hard and he would never give up," Lopez said. "No matter how hard I worked him or how tired he got, he would keep going and ask for more.

"As a recruiter, we get hung up on time management," he continued. "I have 28 high schools and colleges to visit every month in addition to scheduled appointments. Applicants 15 to 20 pounds overweight say they want to join and that they'll lose the weight, then I never hear from them again. But based on Leo's case, now I'll think twice about not taking them seriously."
By Air Force Tech. Sgt. Jennifer Lindsey
Special to American Forces Press Service
(Air Force Tech. Sgt. Jennifer Lindsey serves in the Air Force Recruiting Service public affairs office.)
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Study Shows Machine Perfusion Significantly Improves Transplant Results

/PRNewswire/ -- A landmark study published December 31 in the New England Journal of Medicine (NEJM) demonstrates that use of a specially-designed machine to store kidneys for transplantation offers significant benefits in kidney survival and function when compared to those stored in a traditional "ice box", or cold storage. Unlike the icebox, the LifePort(R) Kidney Transporter monitors the temperature and vascular performance of the organ in real time, while preserving it by pumping the kidney continuously with a cold solution, even while the organ is being transported to its intended recipient.

"This important study confirms the critical role that transportable machine perfusion can play in improving kidney transplant outcomes," said David Kravitz, Chief Executive Officer of Organ Recovery Systems, the manufacturer of LifePort. "It also demonstrates that LifePort should have a central place in all transplantation programs, to help ensure the best possible patient outcomes."

The international trial enrolled kidney pairs from 336 consecutive deceased donors in Europe and randomly assigned one kidney to machine perfusion and the other to static storage. Results showed that the odds of a delay in kidney function post transplant were reduced by almost half when machine perfusion was used compared with static cold storage. Delay in kidney function, or DGF, is a factor that is known to adversely affect the long-term outcome of kidney transplantation. The study also showed that the LifePort kidneys were 48 percent less likely to fail within the first year post-transplant compared to those kidneys stored in the traditional box of ice prior to transplantation. This is the first randomized, prospective study to directly compare the two methods of storing and transporting organs for transplantation.

"For the first time in the United States, the number of those waiting for a life-saving transplant has passed 100,000," said Joseph Vassalotti, MD, Chief Medical Officer of the National Kidney Foundation. "Any new method like the one demonstrated in this study, that will help maximize the available organs and potentially reduce the need for re-transplantation, is vitally important for patients and the professionals who care for them."

More than 1.5 million people worldwide suffer from end stage renal disease, for which a kidney transplant is the preferred treatment option. With a continuing global shortage of organs for transplantation, it is important to find ways of increasing not just the number of kidneys available but also the quality of organs for transplantation to improve the long-term outcome for recipients. By improving the quantity and quality of organs for transplant, both improvements in clinical outcomes and cost savings to health systems are likely to occur.

The LifePort provides a sealed, sterile, protected environment where a physiologic solution is gently pumped through the kidney at cold temperatures to minimize damage while the organ is outside the body. The LifePort is lightweight and portable allowing organs to be perfused and evaluated from the time of recovery until transplant. It can travel unaccompanied by land or air, safely transporting the kidneys across town or between states.

About the Machine Preservation Trial

The Machine Preservation Trial was an investigator-driven study, run by an independent Scientific Steering Committee across The Netherlands, Belgium and Germany, with Eurotransplant (an international organ exchange organization) collaborating as study coordinators. The Machine Preservation trial was sponsored by Organ Recovery Systems of Chicago, USA, manufacturers of the LifePort Kidney Transporter.

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