UGA compound offers new hope for treatment of painful adult shingles

Researchers at the University of Georgia and Yale University have discovered a compound with the potential to be more effective than existing agents in treating the very painful blisters known as shingles—a condition that affects up to 30 percent of Americans, mostly elderly, and for which no specific treatment exists.

Most adults remember the fever, itchy blisters and possibly tiny scars they experienced as children when they had chickenpox, which is caused by the varicella-zoster virus, or VZV.Unfortunately, that memory can come back—with a vengeance—when they are older. The VZV virus from childhood chickenpox hides in the nerves, emerging most frequently in adults over the age of 60 as a blistering rash on one side of the body. The rate of complications, including nerve pain that can persist for months or years after the shingles attack is gone, also increases with age.

The novel and effective anti-shingles agent called L-BHDA may change that. Rights to the shingles treatment have been licensed to Bukwang Pharmaceutical Company for preclinical investigations by the University of Georgia Research Foundation, Inc. and Yale University.

“We need new options for medications with increased potency and specificity that can treat VZV, including strains that may be resistant to existing drugs,” said medicinal chemist Chung (David) Chu, Distinguished Research Professor of Pharmaceutical and Biomedical Sciences at UGA, one of the inventors of L-BHDA.

A collaboration between Chu and co-inventor Yung-Chi (Tommy) Cheng, the Henry Bronson Professor of Pharmacology at Yale, has resulted in an extensive portfolio of antiviral compounds that target such diseases as HIV, shingles, hepatitis and cancers.

Chu, who is head of the Drug Discovery Group in the UGA College of Pharmacy, said that although there are generic antiviral drugs to reduce the duration and pain of shingles, and a variety of pain medications and topical creams to relieve long-term pain, “They are only moderately effective.We need more effective anti-VZV agents.

“L-BHDA has the potential to be more effective than existing agents,” said Chu. He noted that the new compound has been tested in the laboratory and demonstrated in mice models by a group of researchers headed by Jennifer Moffat, associate professor of microbiology and immunology, State University of New York Upstate Medical University.

A vaccine to prevent shingles, available to older adults since 2006, can cut the likelihood of a shingles attack in half. However, according to a recent study in the American Journal of Preventive Medicine, only a small percentage of older people receive the shot, principally because of cost, lack of insurance reimbursement and shortage of supply.

It is likely that immunization against chickenpox during childhood also protects against shingles, because the vaccine uses a weakened strain of the virus. However, the vaccine was only introduced in 1995, and there are not enough data to provide a definitive answer.

“Dr. Chu and Dr. Cheng have been working diligently to fill a much needed gap in the treatment options for such a prevalent disease,” said Rachael Widener, UGARF technology licensing manager. “Before the chicken pox vaccine became widely used in the mid-1990s, older, unvaccinated individuals would have their immunity boosted naturally.

“Now, with less exposure to chicken pox, shingles is becoming more prevalent,” said Widener. “This, combined with the aging baby boomer population, underscores the need for more directed treatment. We are hopeful that L-BHDA will allow patients to get well sooner and feel less pain, and will lessen their chances of complications.”

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FDA approves Zostavax vaccine to prevent shingles in individuals 50 to 59 years of age

The Food and Drug Administration (FDA) today approved the use of Zostavax, a live attenuated virus vaccine, for the prevention of shingles in individuals 50 to 59 years of age. Zostavax is already approved for use in individuals 60 years of age and older.

In the United States shingles affects approximately 200,000 healthy people between the ages of 50 and 59, per year. It is a disease caused by the varicella-zoster virus, which is a virus in the herpes family and the same virus that causes chickenpox. After an attack of chickenpox, the virus lies dormant in certain nerves in the body. For reasons that are not fully understood, the virus can reappear in the form of shingles, more commonly in people with weakened immune systems and with aging.

"The likelihood of shingles increases with age. The availability of Zostavax to a younger age group provides an additional opportunity to prevent this often painful and debilitating disease" said Karen Midthun, M.D., director of FDA's Center for Biologics Evaluation and Research.

Shingles is characterized by a rash of blisters, which generally develop in a band on one side of the body and can cause severe pain that may last for weeks, and in some people, for months or years after the episode.

Approval was based on a multicenter study conducted in the United States and four other countries in approximately 22,000 people who were 50-59 years of age. Half received Zostavax and half received a placebo. Study participants were then monitored for at least one year to see if they developed shingles. Compared with placebo, Zostavax reduced the risk of developing shingles by approximately 70 percent.

The most common side effects observed in the study were redness, pain and swelling at the site of injection, and headache.

Zostavax was originally approved on May 26, 2006, for the prevention of shingles in individuals 60 years of age and older.

Zostavax is manufactured by Merck & Co. Inc., of Whitehouse Station, New Jersey.

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CDC Unveils New Adult Vaccination Rates; nfid Surveys Illuminate Barriers to Vaccine Uptake

/PRNewswire/ -- New data from the Centers for Disease Control and Prevention (CDC) show that adults remain largely unvaccinated against preventable infectious illnesses. At a news conference convened today by the National Foundation for Infectious Diseases (NFID), experts in public health, infectious disease, oncology and other medical specialties discussed the data and the health consequences for adults who skip vaccines. They collectively called on all adults and health care providers to improve vaccination rates.

"For more than six decades, vaccines have protected us from infectious illnesses that have a wide range of consequences, from lost work days and inability to meet our daily obligations, to pain, discomfort, hospitalization, long-term disability and death," said Susan J. Rehm, M.D., NFID medical director. According to Dr. Rehm, by foregoing needed vaccines, adults not only leave themselves vulnerable to sickness, but they expose those around them to unnecessary risks, too.

This problem is evident right now, as pertussis (whooping cough) continues to claim the lives of infants in California, while adults, who are frequently responsible for transmitting the disease to infants, fail to get the one-time pertussis booster vaccine. The impact of other vaccine-preventable infections may not be as immediately apparent, but they are no less important. Other vaccines for adults protect against viruses that cause several types of cancer, reactivation of the chickenpox virus that causes shingles later in life, and infection with bacteria that are the leading cause of community-acquired pneumonia.

New survey results from NFID suggest that doctor/patient communication challenges may be at least part of the problem. While physicians perceive they are encouraging their adult patients to be vaccinated, patients say the topic of vaccination rarely comes up during their doctor visits.

Vaccination rates highest among seniors; lowest among minority groups

In unveiling the adult vaccination data from the 2009 National Health Interview Survey (NHIS), Melinda Wharton, M.D., M.P.H., deputy director of the National Center for Immunization and Respiratory Diseases at the CDC, noted that the highest immunization rates are among older Americans, who tend to be vaccinated against influenza and pneumococcal infections. She suggested that one reason for this might be that older persons tend to have more routine visits with health care providers, providing more opportunities to learn about and adopt good preventive care behaviors.

"A good ongoing relationship with your medical provider is positive for so many reasons," said Dr. Wharton, "not least of which is that you will have an ongoing opportunity learn about the best ways to stay healthy, including the best preventive care choices like vaccines."

While adult vaccination rates are showing slow improvement overall, one vaccination trend Dr. Wharton specifically noted is the 7.4 percent decrease in pneumococcal vaccination rate in high-risk adults 19 to 64 years of age. She pointed out that this is not because people are suddenly foregoing this vaccine. Rather, the decrease reflects the recent addition of new risk groups -- namely smokers and people with asthma -- increasing the pool of people who should get the vaccine. Dr. Wharton called on smokers and people with asthma to check with their physicians or other health care providers about this vaccine.

In addition to generally low adult vaccination rates, Dr. Wharton touched on the problem of racial and ethnic vaccination disparities. While strides have been made to close racial and ethnic gaps, some significant vaccination gaps continue to exist among Whites, Blacks and Hispanics.

Vaccine (age and/or risk status)	Non- Hispanic White (%)	Non- Hispanic Black (%)	Hispanic or Latino (%)
Tetanus, diphtheria, pertussis (19-64 years)	51	54	49
Pneumococcal (65 years and older)	65	45	40
Pneumococcal (19-64 years, high risk)	18	18	12
Hepatitis B (19-49 years, high risk)	43	44	37
HPV (19-26 years)	20	13	13
Shingles (60 years and older)	11	4	5
Influenza (65 years and older)	69	51	51
Influenza (50-64 years)	42	37	31

The NHIS survey also reported vaccination rates in health care professionals for influenza (up 7 percent, to 53 percent), hepatitis B (up 2.5 percent, to 65 percent) and Tdap (up 1.6 percent, to 58 percent). "It's gratifying to see health care worker vaccination rates continue to increase," said CDC's Melinda Wharton. "By modeling good preventive care behaviors our health care professionals are truly leading the way as good partners in their relationship with patients." The NHIS vaccination data include anyone employed in a health care occupation or setting. In contrast, physician-only vaccination rates are much higher (>90 percent for influenza) as reported in two separate NFID surveys fielded before and during the current influenza season.

Doctor/patient communication breakdown a factor in low vaccination rates

A dramatic physician-patient communication disconnect was revealed by new data from two NFID surveys. Nearly 90 percent of primary care physicians say they discuss vaccines with their patients, yet in a separate survey of consumers, almost half cannot recall ever discussing vaccines with their physicians. As further evidence of the communication gap between physicians and their patients, 99 percent of physicians say that they or their staff initiates vaccine discussions, but just 44 percent of patients say that is true.

"Busy primary care physicians think they're doing a good job recommending vaccines, but the survey indicates that patients aren't getting the message," suggested Dr. Rehm. "Consumers overwhelmingly said they look to physicians for vaccine recommendations and are likely to act on those recommendations, so it's clear that we physicians need to be more effective in communicating with our patients."

Among the positive findings, consumer familiarity with vaccine-preventable illnesses is rising, although still limited. Familiarity with specific vaccine-preventable diseases rose 4 to 12 percent compared with results from a 2009 survey, with the largest increase for pertussis vaccine. The only vaccine-preventable disease not to register an increase in familiarity is pneumococcal vaccine. Consumers also report that they rarely refuse vaccines if their physicians recommend them.

A realized consequence: disease resurgence

The ongoing pertussis epidemic in California demonstrates the danger still posed by diseases once thought to be gone in the U.S. There are reports of more than 6,400 cases so far in California this year, the most since 1958. While pertussis can affect people of any age and in fact, national rates have been rising in adults, it is the infants who adults pass this on to who bear the burden. Ten infants, all younger than three months, have died from whooping cough in California this year.

Patrick Joseph, M.D., a California infectious disease physician who is NFID's vice president, implored adults to get the one-time booster vaccine, "While the epidemic is in adults, the tragedy is in kids. The situation is grave when babies too young to be immunized are dying."

Dr. Joseph said this crisis means California doesn't have the luxury of bringing people along slowly. The time to increase vaccination rates for pertussis is now. The California Department of Public Health recommends pertussis boosters for all adults, including those over 65, a move supported by the CDC's Advisory Committee on Immunization Practices (ACIP). At its October meeting, ACIP voted to extend pertussis booster vaccination recommendations to include adults 65 and older nationwide.

While California has been hardest hit so far, many other areas have seen increased cases this year, including Ohio, South Carolina, Michigan, Texas, Idaho, upstate New York and the Philadelphia suburbs. Since pertussis knows no boundaries, Dr. Joseph voiced his hope that adults outside his home state would also take notice and seek a Tdap vaccine now to protect themselves and infants around them.

Importance of pneumococcal and influenza vaccines also highlighted

AARP board member Catherine Georges, R.N., Ed.D., reminded adults that the time to get an influenza vaccine is now. "We know it's important for Americans of all ages to go out now and get the flu vaccine, but it's even more critical for people 50-plus," said Dr. Georges, a registered nurse and professor and chair of the department of nursing at Lehman College and the Graduate Center at the City University of New York. "Older Americans are often caring for their children and for older loved ones. Getting vaccinated not only protects you, but also helps protect your family and friends." Dr. Georges echoed the universal recommendation from CDC for influenza vaccination of all Americans six months and older.

Since pneumococcal infection is an all too frequent complication of influenza, Dr. Georges reminded Americans that, "pneumococcal and influenza vaccines can be given at the same medical visit." Pneumococcal vaccine is recommended for everyone 65 and older and for younger adults with certain risk factors or conditions like asthma, smoking, heart disease and diabetes. For most people, pneumococcal is a one-time vaccination.

Alarmingly few Americans immunized against debilitating disease of shingles

The lowest vaccination rate for a routinely recommended vaccine is for the shingles vaccine, which is recommended for everyone starting at age 60. Only ten percent of eligible persons have received the shingles vaccine. Not only does the likelihood of getting shingles increase with age, so does the severity of shingles pain, which can last long after the shingles rash has disappeared (this pain is known as post-herpetic neuralgia, or PHN). This pain diminishes quality of life and functional capacity as much as congestive heart failure, a heart attack, type II diabetes or major depression.

Adults in the NFID survey say they are familiar with shingles, but further questioning reveals knowledge gaps; for instance, 42 percent do not know that anyone who has had chickenpox is at risk for shingles. Still, adults are aware of the pain of the disease; 55 percent say they "know someone who has had it and it was terrible." Unfortunately, only half of adults even know there is a shingles vaccine available and just 16 percent know it is currently recommended for everyone 60 and older.

"Shingles can be a terribly painful and debilitating disease, particularly in the elderly," said Jeffrey Cohen, M.D., chief of the Laboratory of Infectious Disease at the National Institute of Allergy and Infectious Diseases. "Shingles pain can be very difficult to treat. Current therapies are only somewhat effective and often associated with frequent and problematic side effects, especially in older people, which is why it is vitally important that we educate Americans about the vaccine."

Vaccines prevent cancer

"Human papillomavirus (HPV) not only causes cervical cancer, but also a growing portion of head and neck cancers," according to Maura Gillison, M.D., Ph.D, Jeg Coughlin Chair of Cancer Research at the Ohio State University College of Medicine. "Twenty years ago about 40 percent of these cancers were due to HPV; today that number is over 60 percent in the U.S. Even more alarming is that these cancers are happening in younger people without traditional risk factors—smoking and alcohol consumption."

The hepatitis B vaccine also protects against certain cancers. The hepatitis B virus causes 30 percent of all liver cancers in the U.S. and doubles the risk of non-Hodgkin's lymphoma. Both HPV and hepatitis B viruses are common. An estimated 70 percent of Americans will be infected with HPV in their lifetime and up to 1.4 million Americans have chronic hepatitis B infection.

CDC recommends HPV vaccine for all women 19 to 26 years of age if not previously vaccinated and recommends the hepatitis B vaccine for all sexually active adults who are not in a long-term, mutually monogamous relationship and others in more defined risk groups.

"I urge everyone to get the HPV and hepatitis B vaccines as recommended," said Dr. Gillison. "These vaccines are truly life-saving. As a cancer-specialist, I can tell you that prevention is a far better option than treatment. These are not cancers you want to have or want your kids to have."

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FDA Approves New Drug Treatment for Long-Term Pain Relief after Shingles Attacks

The Food and Drug Administration (FDA) has approved the approval of Qutenza (capsaicin) 8% patch, a medicated skin patch that relieves the pain of post-herpetic neuralgia (PHN), a serious complication that can occur after a bout with shingles.

Shingles is an outbreak of rash or blisters on the skin that is caused by the same virus that causes chickenpox — the varicella-zoster virus. Anyone who once had chickenpox is at risk of shingles since the virus may become reactivated years after the initial infection. PHN is a condition affecting nerve fibers and the skin that can cause excruciating pain for weeks, months or even years. About 10 to 15 percent of patients who have shingles experience PHN and the complication is even more common in elderly patients.

Qutenza contains capsaicin, a compound found in chili peppers. Although there are over-the-counter products with lower concentrations of capsaicin that are marketed for the treatment of PHN, Qutenza is the first pure, concentrated, synthetic capsaicin-containing prescription drug to undergo FDA review . It was approved on Nov. 16.

“This new product can provide effective pain relief for patients who suffer from PHN,” said Bob Rappaport, M.D., director of the Division of Anesthesia, Analgesia and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.

The most frequently reported adverse drug reactions included pain, swelling, itching, redness, and bumps at the application site.

Qutenza must be applied to the skin by a health care professional since placement of the patch can be quite painful, requiring use of a local topical anesthetic, as well as additional pain relief such as ice or use of opioid pain relievers. The patient must also be monitored for at least one hour since there is a risk of a significant rise in blood pressure following patch placement.

The patch is manufactured by Lohmann Therapie-Systems AD of Andernach, Germany and distributed by NeurogesX Inc. of San Mateo, Calif.

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Healing Pain Through the Art of Quilting

Patchwork of Hope Network (TM) Visits Atlanta to Raise Awareness of After-Shingles Pain

A local quilting group has joined a national initiative to help raise awareness of after-shingles pain, or postherpetic neuralgia (PHN), a particularly painful and debilitating disease. The group will be hosting an educational seminar in the area and invite members of the community to share their stories and reveal their quilting skills. Attendees will help by contributing to a patchwork quilt that is a handmade memorial and testimonial to those who suffer, and a reminder that they are a member of a community and do not have to face after-shingles pain alone.

Approximately 1 million Americans will suffer from shingles each year, and one in five of those people may develop PHN. PHN results from nerve damage caused by the shingles virus. For some PHN patients, a gentle breeze or a slight change in temperature can cause excruciating pain.

Together the National Council on Aging (NCOA) and the National Pain Foundation (NPF) are spreading the word about PHN through the Patchwork of Hope Network (P.H.N.) program. This often debilitating condition can affect not only those suffering, but their family and friends as well.

The campaign includes several live events throughout the year where attendees will hear presentations about PHN symptoms and potential treatment options, meet others affected by PHN and have an opportunity to create individual quilt squares to tell their story about how PHN has affected their lives.

Local physician Anthony Grasso, M.D., a pain management specialist at Non-Surgical Orthopaedics, P.C. and affiliated with Wellstar Health System, will discuss shingles and after-shingles pain and ways to cope. Additionally, a local PHN patient will share her personal experience with PHN and John Sebby, of the NPF, will discuss resources for dealing with PHN.

WHEN: Wednesday, August 19
10 a.m. to 12 noon

WHERE: Lou Walker Senior Center
2538 Panola Road
Lithonia, GA 30058
(770) 322-2900

About National Pain Foundation

The National Pain Foundation (NPF), a non-profit organization, is the premier provider of information, education and support to people with chronic pain. Materials are provided for both patients and medical professionals interested in the field of chronic pain. The NPF aims to empower people in pain by educating them about their condition, providing information about the options available for managing their pain, teaching them to take a more active role in their treatment plan and helping them to connect with others who also are on this journey. For more information, visit www.nationalpainfoundation.org.

About National Council on Aging

The National Council on Aging (NCOA) is a non-profit service and advocacy organization headquartered in Washington, DC. NCOA is a national voice for older Americans - especially those who are vulnerable and disadvantaged - and the community organizations that serve them. It brings together non-profit organizations, businesses and government to develop creative solutions that improve the lives of all older adults. NCOA works with thousands of organizations across the country to help seniors find jobs and benefits improve their health, live independently and remain active in their communities. For more information, visit www.ncoa.org.
REFERENCES

Harpaz R, Ortega-Sanchez IR and Seward JF. Prevention of Herpes Zoster: Recommendations of the Advisory Committee on Immunization Practices (ACIP). Morbidity and Mortality Weekly Report. 2008; 57(05): 1-30. Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5705a1.htm. Accessed February 20, 2009.

Shingles Vaccine: What You Need to Know. Department of Health and Human Services: Centers for Disease Control. Available at: http://www.cdc.gov/vaccines/pubs/vis/downloads/vis-shingles.pdf. Accessed February 15, 2009.

Cure PHN: Your Questions Answered. VZV Research Foundation, Inc. 2004: 1-6. Available at: http://www.vzvfoundation.org/publicdownloads/PHN_Brochure_Feb2004.pdf. Accessed February 9, 2009.

Galer BS. Advances in the Treatment of Postherpetic Neuralgia: The Topical Lidocaine Patch. Today’s Therapeutic Trends. 2000; 1-20.
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Free Seminar on Shingles in Lithonia Aug 19

The Patchwork of Hope NetworkTM (P.H.N.), together with a local quilting group and local physician Anthony Grasso, M.D., a pain management specialist at Non-Surgical Orthopaedics, P.C. and affiliated with Wellstar Health System, will host a free interactive seminar on shingles and after-shingles pain, or postherpetic neuralgia (PHN) at the Lou Walker Senior Center on Wednesday, August 19 from 10 a.m. to 12 noon.

Together the National Council on Aging (NCOA) and the National Pain Foundation (NPF) are spreading the word about PHN through the P.H.N. program. This often debilitating condition can affect not only those suffering, but their family and friends as well.

The campaign, which consists of six educational events throughout the year and across the country, will give attendees the chance to hear presentations about shingles and after-shingles pain, meet others affected by after-shingles pain, and contribute to the P.H.N. quilt. For more information, visit www.AfterShingles.com. This campaign is made possible with support from Endo Pharmaceuticals.

Approximately 1 million Americans will develop shingles each year, particularly those who are 50 years of age and older with weakened immune systems. One out of every five will go on to develop postherpetic neuralgia (PHN) or after-shingles pain. PHN results from nerve damage caused by the shingles virus, and for many the pain is often debilitating and can causes feelings of isolation.

WHEN: Wednesday, August 19
10 a.m. to 12 noon

WHERE: Lou Walker Senior Center
2538 Panola Road
Lithonia, GA 30058
(770) 322-2900

WHO: Dr. Grasso, a pain management specialist at Non-Surgical Orthopaedics, P.C. and affiliated with Wellstar Health System, will discuss shingles and after-shingles pain and ways to cope with after-shingles pain. A patient will share her personal experience with after-shingles pain and John Sebby, of the NPF, will discuss additional resources for dealing with the condition. The event will be emceed by Christine Harding, of the NCOA.
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