From Medscape Medical News
Barbara Boughton
September 22, 2009 (San Francisco, California) — An investigational 13-valent pneumococcal conjugate vaccine manufactured by Wyeth, currently under review by the US Food and Drug Administration (FDA), should help eliminate newly emerging drug-resistant pneumococcal strains.
Despite the success of the pediatric 7-valent pneumococcal conjugate vaccine (Prevnar, Wyeth) that was introduced in 2000, drug-resistant pneumococcal strains — particularly the 19A serotype — have emerged and threaten the health of some children, particularly those 2 to 4 years of age with underlying health conditions. These children might benefit from catch-up immunizations with the 13-valent vaccine, pending approval, according to 2 teams of researchers here at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).
"We are at the point where we've already reduced 80% of the disease burden," said Pekka Nuorti, MD, DSc, from the Respiratory Disease Branch of the Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia, which sponsored one of the studies. "But we wanted to see how much of the remaining disease is vaccine-preventable."
In their study, the CDC researchers assessed the number of cases of invasive pneumococcal disease (IPD) in 2007 and identified the isolates from these cases.
They found that 64% of the estimated 5040 cases of IPD were caused by serotypes targeted by the new 13-valent vaccine, whereas only 2% were caused by serotypes contained in the currently used vaccine. Serotype 19A accounted for 42% of cases.
The 13-valent vaccine "has the potential to substantially reduce the remaining [pneumococcal] disease burden," Dr. Nuorti said in an interview with Medscape Infectious Diseases. "It looks like there might be some groups that might benefit from a catch-up immunization — including older children with underlying medical conditions."When it makes its recommendations for the vaccine, the CDC will also consider a catch-up vaccination strategy for all children 2 to 4 years of age to extend the vaccine's protection to unvaccinated groups, he said. The vaccine is expected to be licensed by the FDA later this year or early next year.
In another study presented here at the ICAAC, researchers from University Hospitals Case Medical Center in Cleveland, Ohio assessed isolates from 171 cases of Streptococcus pneumonias at their institution in 2008.
Nonvaccine serotypes predominated, and 19A was the most commonly isolated serotype, accounting for about a third of all cases.
"There's been an incredible increase in nonvaccine serotypes and most of that increase is due to 19A," said lead researcher Michael R Jacobs, MD, PhD, director of pathology and medicine at Case Western Reserve University in Cleveland. "No one really predicted this when the [7-valent] vaccine was first introduced," Dr. Jacobs said in an interview with Medscape Infectious Diseases. "Some scientists hypothesized that serotype 19F, which is contained in the 7-valent vaccine, might provide cross-protection against 19A, but that hasn't proved to be the case," Dr. Jacobs added.
In the Cleveland study, most of the nonvaccine isolates, particularly 19A, were resistant to many antibiotics, including penicillin, amoxicillin, ceftriaxone, azithromycin, and clindamycin. "This [increase in nonvaccine isolates] may well represent a trend of replacement serotypes and increasing invasiveness and drug nonsusceptibility, and bears careful watching," the authors conclude in their study.
Although agreeing that the 7-valent vaccine has reduced the morbidity and mortality burden from pneumococcal disease, other researchers consider the growth in drug-resistant replacement serotypes a concern.
"The routine use of hepavalent pneumococcal vaccine [PCV 7] has substantially reduced the rate of invasive pneumococcal disease in children and in the general population," said Luke Chen, MBBS, FRACP, assistant professor of medicine in the Division of Infectious Diseases at Duke University Medical Center in Durham, North Carolina. "However, many investigators have also described an increase in the rate of IPDs caused by serotypes of pneumococci that were not included in PCV 7 — a phenomenon known as 'serotype replacement'," Dr. Chen said.
"The evolving epidemiology of pneumococci is of interest because some nonvaccine serotype pneumococci, such as 19A, are associated with increasing antimicrobial resistance. Other nonvaccine serotypes, such as serotypes 1 and 5, are associated with higher rates of invasive pulmonary disease, such as empyemas and parapneumonic effusions," Dr. Chen added.
The results of the Cleveland study presented by Dr. Jacobs and colleagues are alarming because more than 70% of all serotype 19A isolates were not susceptible to penicillin or ceftriaxone, according to Dr. Chen. "It remains unclear, however, whether the emergence of non-PCV 7 serotype pneumococci and increasing antimicrobial resistance are associated with excess mortality or morbidity," he added.
The CDC study's data are interesting because they project a substantial and further reduction in the overall rates of IPD after transitioning from PCV 7 to a 13-valent pneumococcal vaccine, Dr. Chen said. "PCV 13 may also reduce the incidence of serotypes that are associated with increasing antimicrobial resistance, such as 19A," he added.
Dr. Nuorti, Dr. Jacobs, and Dr. Chen have disclosed no relevant financial relationships.
49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC): Abstracts G1-1554 and G1-1536. Presented September 14, 2009.
Friday, September 25, 2009
Friday, September 18, 2009
Atopic Dermatitis - update on treatment
Pediatrics. 2008;122:812-824.
Clinical Context
AD affects 10% to 20% of children, according to Larsen and Hanifin in the February 2002 issue of Immunology and Allergy Clinics of North America. The primary factors in AD are epidermal barrier function defects and skin inflammation. The diagnosis of AD is based on combined essential, important, and associated nonspecific features. Essential features include pruritus, eczematous dermatitis, typical morphologic features with age-specific patterns, and chronic or relapsing nature.
This review of AD describes the management of AD, including topical corticosteroids, topical calcineurin inhibitors, and new treatments.
Study Highlights
Education is a crucial part of management:
A 6-week education program for parents resulted in improved quality of life and eczema severity for their children older than 12 months.
Comprehensive centers can provide care in dermatology, allergy, infectious disease, and behavioral psychology.
Trigger avoidance measures include mattress covers, low-pile carpet, pets that do not produce dander, and avoidance of known food allergens.
The American Academy of Pediatrics 2008 breast-feeding guidelines recommend exclusive breast-feeding for at least 4 months to decrease AD incidence in the first 2 years of life in children at high risk for AD.
There is no evidence that delaying solid food, including cow's milk, fish, eggs, and peanut-containing foods, after ages 4 to 6 months protects against AD.
Studies on probiotic effects on risk for AD had conflicting results.
Skin care recommendations include dye-free, fragrance-free emollients and moisturizers applied at least twice a day, ointments, and ceramide-rich products.
"510(k) medical devices" are approved by the US Food and Drug Administration as new barrier products.
Bathing in lukewarm water with moisturizing cleanser for several minutes once or twice a day should be followed by use of a towel to pat dry and emollients.
Avoid fragrance soaps or bubble baths.
First-line treatment of AD flares is topical corticosteroids:
Class I are most potent and class VII, least potent.
Adverse effects are skin atrophy, striae, telangiectasias, hypopigmentation, rosacea, perioral dermatitis, acne, cataracts, glaucoma, hypothalamic-pituitary-adrenal axis suppression, growth retardation, and bone density reduction.
Twice-a-day use has the same effect as once-a-day use.
The topical calcineurin inhibitors tacrolimus and pimecrolimus are second-line treatment for short-term and noncontinuous long-term use in immunocompetent patients at least 2 years old with moderate to severe AD:
Long-term safety is not known, according to 2006 US Food and Drug Administration boxed warning.
Indications include AD persistence or frequent flares requiring almost continuous topical corticosteroids and involvement of sensitive skin areas.
Sedating antihistamines hydroxyzine and diphenhydramine might improve sleep but do not directly affect AD-related pruritus.
Possible complications include overgrowth of S aureus, Molluscum contagiosum, eczema herpeticum, eczema vaccinatum, and fungal infections.
If bacterial superinfection occurs, culture for methicillin-resistant S aureus should be considered.
Diluted bleach baths can decrease local skin infections and need for systemic antibiotics.
Wet wraps and once-daily topical corticosteroids are effective for severe or refractory AD, but close supervision is needed because of risk for skin maceration or secondary infection.
Systemic immunomodulatory therapies can be used for refractory AD:
Multiple phototherapy sessions
Short-term cyclosporine; long-term use can be linked with hypertension and renal toxicity
Azathioprine monotherapy; monitor blood cell counts and liver function tests
Mycophenolate mofetil appears safe; prospective controlled studies are needed.
Dermatology referral indications include moderate or severe AD, poor response to moderate-potency topical corticosteroids, persistent AD, frequent flares, AD-related hospitalization, and systemic therapy.
Other specialty referrals include allergy referral for suspected specific triggers and gastroenterology or immunology referral for possible eosinophilic gastroenteritis or esophagitis with failure to thrive or frequent systemic infections.
Pearls for Practice
In children with atopic dermatitis, the first-line treatment is topical corticosteroids, with potency ranging from the least potent class VII to the most potent class I. Second-line treatment of frequent flares or sensitive skin areas is a topical calcineurin inhibitor, for use in children 2 years or older.
New treatment modalities for children with atopic dermatitis include education models; bleach bath; wet wraps; and systemic immunomodulatory therapies, including phototherapy, cyclosporine, azathioprine, and mycophenolate mofetil.
Clinical Context
AD affects 10% to 20% of children, according to Larsen and Hanifin in the February 2002 issue of Immunology and Allergy Clinics of North America. The primary factors in AD are epidermal barrier function defects and skin inflammation. The diagnosis of AD is based on combined essential, important, and associated nonspecific features. Essential features include pruritus, eczematous dermatitis, typical morphologic features with age-specific patterns, and chronic or relapsing nature.
This review of AD describes the management of AD, including topical corticosteroids, topical calcineurin inhibitors, and new treatments.
Study Highlights
Education is a crucial part of management:
A 6-week education program for parents resulted in improved quality of life and eczema severity for their children older than 12 months.
Comprehensive centers can provide care in dermatology, allergy, infectious disease, and behavioral psychology.
Trigger avoidance measures include mattress covers, low-pile carpet, pets that do not produce dander, and avoidance of known food allergens.
The American Academy of Pediatrics 2008 breast-feeding guidelines recommend exclusive breast-feeding for at least 4 months to decrease AD incidence in the first 2 years of life in children at high risk for AD.
There is no evidence that delaying solid food, including cow's milk, fish, eggs, and peanut-containing foods, after ages 4 to 6 months protects against AD.
Studies on probiotic effects on risk for AD had conflicting results.
Skin care recommendations include dye-free, fragrance-free emollients and moisturizers applied at least twice a day, ointments, and ceramide-rich products.
"510(k) medical devices" are approved by the US Food and Drug Administration as new barrier products.
Bathing in lukewarm water with moisturizing cleanser for several minutes once or twice a day should be followed by use of a towel to pat dry and emollients.
Avoid fragrance soaps or bubble baths.
First-line treatment of AD flares is topical corticosteroids:
Class I are most potent and class VII, least potent.
Adverse effects are skin atrophy, striae, telangiectasias, hypopigmentation, rosacea, perioral dermatitis, acne, cataracts, glaucoma, hypothalamic-pituitary-adrenal axis suppression, growth retardation, and bone density reduction.
Twice-a-day use has the same effect as once-a-day use.
The topical calcineurin inhibitors tacrolimus and pimecrolimus are second-line treatment for short-term and noncontinuous long-term use in immunocompetent patients at least 2 years old with moderate to severe AD:
Long-term safety is not known, according to 2006 US Food and Drug Administration boxed warning.
Indications include AD persistence or frequent flares requiring almost continuous topical corticosteroids and involvement of sensitive skin areas.
Sedating antihistamines hydroxyzine and diphenhydramine might improve sleep but do not directly affect AD-related pruritus.
Possible complications include overgrowth of S aureus, Molluscum contagiosum, eczema herpeticum, eczema vaccinatum, and fungal infections.
If bacterial superinfection occurs, culture for methicillin-resistant S aureus should be considered.
Diluted bleach baths can decrease local skin infections and need for systemic antibiotics.
Wet wraps and once-daily topical corticosteroids are effective for severe or refractory AD, but close supervision is needed because of risk for skin maceration or secondary infection.
Systemic immunomodulatory therapies can be used for refractory AD:
Multiple phototherapy sessions
Short-term cyclosporine; long-term use can be linked with hypertension and renal toxicity
Azathioprine monotherapy; monitor blood cell counts and liver function tests
Mycophenolate mofetil appears safe; prospective controlled studies are needed.
Dermatology referral indications include moderate or severe AD, poor response to moderate-potency topical corticosteroids, persistent AD, frequent flares, AD-related hospitalization, and systemic therapy.
Other specialty referrals include allergy referral for suspected specific triggers and gastroenterology or immunology referral for possible eosinophilic gastroenteritis or esophagitis with failure to thrive or frequent systemic infections.
Pearls for Practice
In children with atopic dermatitis, the first-line treatment is topical corticosteroids, with potency ranging from the least potent class VII to the most potent class I. Second-line treatment of frequent flares or sensitive skin areas is a topical calcineurin inhibitor, for use in children 2 years or older.
New treatment modalities for children with atopic dermatitis include education models; bleach bath; wet wraps; and systemic immunomodulatory therapies, including phototherapy, cyclosporine, azathioprine, and mycophenolate mofetil.
Monday, September 14, 2009
Nonadjuvanted Influenza Vaccines May Not Protect Against 2009 H1N1
From Medscape Medical News
Laurie Barclay, MD
September 11, 2009 — Recent seasonal nonadjuvanted influenza vaccines may not protect against pandemic H1N1 virus (2009 H1N1), according to the results of a study reported online September 10 issue in the New England Journal of Medicine.
"A new pandemic influenza A (H1N1) virus has emerged, causing illness globally, primarily in younger age groups," write Kathy Hancock, PhD, from the Influenza Division, National Center for Immunization and Respiratory Diseases, the Centers for Disease Control and Prevention, Atlanta, Georgia, and colleagues. "To assess the level of preexisting immunity in humans and to evaluate seasonal vaccine strategies, we measured the antibody response to the pandemic virus resulting from previous influenza infection or vaccination in different age groups."
The investigators used a microneutralization assay to quantify titers of antibodies cross-reactive to 2009 H1N1 in stored serum samples from individuals who either donated blood or who received recent seasonal or 1976 swine influenza vaccines.
Preexisting cross-reactive antibody titers of 40 or more against 2009 H1N1 were present in 4 (4%) of 107 persons born after 1980. In contrast, 39 (34%) of 115 persons born before 1950 had titers of 80 or more.
The level of cross-reactive antibody to 2009 H1N1 increased by 4-fold or greater after receipt of seasonal trivalent inactivated influenza vaccines in none of 55 children aged 6 months to 9 years, in 12% to 22% of 231 adults aged 18 to 64 years, and in 5% or less of 113 adults aged 60 years or older. Cross-reactive antibody responses were not improved by seasonal vaccines formulated with adjuvant. In adults, administration of the A/New Jersey/1976 swine influenza vaccine substantially increased cross-reactive antibodies to 2009 H1N1.
"Vaccination with recent seasonal nonadjuvanted influenza vaccines induced little or no cross-reactive antibody response to 2009 H1N1 in any age group," the study authors write. "Persons under the age of 30 years had little evidence of cross-reactive antibodies to the pandemic virus. However, a proportion of older adults had preexisting cross-reactive antibodies."
Limitations of this study include the relatively small number of samples from pediatric trials.
"It remains clear that optimal protection against 2009 H1N1 in persons of all ages will be achieved with the development of a strain-specific pandemic vaccine," the study authors write. "Whether a one-dose or a two-dose vaccine regimen is needed to adequately immunize various age groups and whether the use of adjuvants will broaden the immune response against 2009 H1N1 if drifted strains emerge or provide dose-sparing benefits will ultimately be determined by the results of clinical studies that are now underway."
N Engl J Med. Published online September 10, 2009.
Laurie Barclay, MD
September 11, 2009 — Recent seasonal nonadjuvanted influenza vaccines may not protect against pandemic H1N1 virus (2009 H1N1), according to the results of a study reported online September 10 issue in the New England Journal of Medicine.
"A new pandemic influenza A (H1N1) virus has emerged, causing illness globally, primarily in younger age groups," write Kathy Hancock, PhD, from the Influenza Division, National Center for Immunization and Respiratory Diseases, the Centers for Disease Control and Prevention, Atlanta, Georgia, and colleagues. "To assess the level of preexisting immunity in humans and to evaluate seasonal vaccine strategies, we measured the antibody response to the pandemic virus resulting from previous influenza infection or vaccination in different age groups."
The investigators used a microneutralization assay to quantify titers of antibodies cross-reactive to 2009 H1N1 in stored serum samples from individuals who either donated blood or who received recent seasonal or 1976 swine influenza vaccines.
Preexisting cross-reactive antibody titers of 40 or more against 2009 H1N1 were present in 4 (4%) of 107 persons born after 1980. In contrast, 39 (34%) of 115 persons born before 1950 had titers of 80 or more.
The level of cross-reactive antibody to 2009 H1N1 increased by 4-fold or greater after receipt of seasonal trivalent inactivated influenza vaccines in none of 55 children aged 6 months to 9 years, in 12% to 22% of 231 adults aged 18 to 64 years, and in 5% or less of 113 adults aged 60 years or older. Cross-reactive antibody responses were not improved by seasonal vaccines formulated with adjuvant. In adults, administration of the A/New Jersey/1976 swine influenza vaccine substantially increased cross-reactive antibodies to 2009 H1N1.
"Vaccination with recent seasonal nonadjuvanted influenza vaccines induced little or no cross-reactive antibody response to 2009 H1N1 in any age group," the study authors write. "Persons under the age of 30 years had little evidence of cross-reactive antibodies to the pandemic virus. However, a proportion of older adults had preexisting cross-reactive antibodies."
Limitations of this study include the relatively small number of samples from pediatric trials.
"It remains clear that optimal protection against 2009 H1N1 in persons of all ages will be achieved with the development of a strain-specific pandemic vaccine," the study authors write. "Whether a one-dose or a two-dose vaccine regimen is needed to adequately immunize various age groups and whether the use of adjuvants will broaden the immune response against 2009 H1N1 if drifted strains emerge or provide dose-sparing benefits will ultimately be determined by the results of clinical studies that are now underway."
N Engl J Med. Published online September 10, 2009.
ACIP Updates Recommendations for Routine Poliovirus Vaccination
From Medscape Medical News
Laurie Barclay, MD
August 7, 2009 — The Advisory Committee on Immunization Practices (ACIP) has updated its recommendations for routine poliovirus vaccination and published them in the August 7 issue of the Morbidity and Mortality Weekly Report.
The goals of the update are to highlight the importance of the booster dose in children older than 4 years, to extend the minimum interval between dose 3 and dose 4 from 4 weeks to 6 months, to include a new precaution regarding use of minimum intervals in the first 6 months of life, and to recommend schedules for poliovirus vaccination with specific combination vaccines.
"On June 17, 1999, ACIP recommended that all poliovirus vaccine administered in the United States be an inactivated poliovirus vaccine (IPV) beginning January 1, 2000," the report states. "This policy was implemented to eliminate the risk for vaccine-associated paralytic poliomyelitis, a rare condition that has been associated with use of the live oral poliovirus vaccine.... Since 1999, no [oral poliovirus vaccine] has been distributed in the United States."
The 1999 ACIP recommendations specified a routine IPV vaccination schedule of 4 doses given at ages 2 months, 4 months, 6 to 18 months, and 4 to 6 years, with 4 weeks being the minimum interval between all IPV doses. In the United States, 3 different combination vaccines containing IPV have been licensed for routine use since the 2000 ACIP recommendation was made in1999.
The updated ACIP guidelines now include the following recommendations to avoid potential confusion related to using different vaccine products for routine and catch-up immunization:
The 4-dose IPV series should still be given at ages 2 months, 4 months, 6 to 18 months, and 4 to 6 years.
Regardless of the number of previous doses, the final dose in the IPV series should be given at age older than 4 years.
Between dose 3 and dose 4, the minimum interval is increased from 4 weeks to 6 months.
Between dose 1 and dose 2, and between dose 2 and dose 3, the minimum interval is still 4 weeks.
For dose 1, the minimum age is still 6 weeks.
Another new ACIP recommendation is that use of the minimum age and minimum intervals for vaccination in the first 6 months of life are recommended only if the vaccine recipient is at risk for imminent exposure to circulating poliovirus; for example, during an outbreak or for travel to a polio-endemic region. The rationale for this new precaution is that shorter intervals and earlier start dates result in lower seroconversion rates.
ACIP is also recommending a poliovirus vaccination schedule with specific combination vaccines, as follows:
When DTaP-IPV/Hib (Pentacel, Sanofi Pasteur) is given at ages 2, 4, 6, and 15 to 18 months (4 doses total), children should receive an additional booster dose of age-appropriate IPV-containing vaccine (IPV [Ipol, Sanofi Pasteur] or DTaP-IPV [Kinrix, GlaxoSmithKline]) at age 4 to 6 years, resulting in a 5-dose IPV vaccine series.
The booster dose at age 4 to 6 years should not be DTaP-IPV/Hib.
For optimal booster response, the minimum interval between dose 4 and dose 5 should be at least 6 months.
As per current recommendations, a booster dose should be given as soon as feasible to a child missing an IPV dose at age 4 to 6 years.
Morb Mortal Wkly Rep. 2009;58:829–830.
Laurie Barclay, MD
August 7, 2009 — The Advisory Committee on Immunization Practices (ACIP) has updated its recommendations for routine poliovirus vaccination and published them in the August 7 issue of the Morbidity and Mortality Weekly Report.
The goals of the update are to highlight the importance of the booster dose in children older than 4 years, to extend the minimum interval between dose 3 and dose 4 from 4 weeks to 6 months, to include a new precaution regarding use of minimum intervals in the first 6 months of life, and to recommend schedules for poliovirus vaccination with specific combination vaccines.
"On June 17, 1999, ACIP recommended that all poliovirus vaccine administered in the United States be an inactivated poliovirus vaccine (IPV) beginning January 1, 2000," the report states. "This policy was implemented to eliminate the risk for vaccine-associated paralytic poliomyelitis, a rare condition that has been associated with use of the live oral poliovirus vaccine.... Since 1999, no [oral poliovirus vaccine] has been distributed in the United States."
The 1999 ACIP recommendations specified a routine IPV vaccination schedule of 4 doses given at ages 2 months, 4 months, 6 to 18 months, and 4 to 6 years, with 4 weeks being the minimum interval between all IPV doses. In the United States, 3 different combination vaccines containing IPV have been licensed for routine use since the 2000 ACIP recommendation was made in1999.
The updated ACIP guidelines now include the following recommendations to avoid potential confusion related to using different vaccine products for routine and catch-up immunization:
The 4-dose IPV series should still be given at ages 2 months, 4 months, 6 to 18 months, and 4 to 6 years.
Regardless of the number of previous doses, the final dose in the IPV series should be given at age older than 4 years.
Between dose 3 and dose 4, the minimum interval is increased from 4 weeks to 6 months.
Between dose 1 and dose 2, and between dose 2 and dose 3, the minimum interval is still 4 weeks.
For dose 1, the minimum age is still 6 weeks.
Another new ACIP recommendation is that use of the minimum age and minimum intervals for vaccination in the first 6 months of life are recommended only if the vaccine recipient is at risk for imminent exposure to circulating poliovirus; for example, during an outbreak or for travel to a polio-endemic region. The rationale for this new precaution is that shorter intervals and earlier start dates result in lower seroconversion rates.
ACIP is also recommending a poliovirus vaccination schedule with specific combination vaccines, as follows:
When DTaP-IPV/Hib (Pentacel, Sanofi Pasteur) is given at ages 2, 4, 6, and 15 to 18 months (4 doses total), children should receive an additional booster dose of age-appropriate IPV-containing vaccine (IPV [Ipol, Sanofi Pasteur] or DTaP-IPV [Kinrix, GlaxoSmithKline]) at age 4 to 6 years, resulting in a 5-dose IPV vaccine series.
The booster dose at age 4 to 6 years should not be DTaP-IPV/Hib.
For optimal booster response, the minimum interval between dose 4 and dose 5 should be at least 6 months.
As per current recommendations, a booster dose should be given as soon as feasible to a child missing an IPV dose at age 4 to 6 years.
Morb Mortal Wkly Rep. 2009;58:829–830.
Fully Vaccinated Kids Still Get Chickenpox During Outbreak
From Reuters Health Information
(Reuters Health) Aug 12 - During an outbreak of varicella in an elementary school in Arkansas, students who were vaccinated once or twice still came down with the illness, though their symptoms were mild.
Furthermore, vaccine effectiveness was no better among those who received two inoculations prior to the outbreak than those who received only one, researchers report in the Pediatric Infectious Disease Journal for August.
"As our understanding of the effectiveness of one dose of varicella has developed (with) postlicensure studies, additional studies will be needed to assess the impact of the routine two-dose recommendation by the ACIP (Advisory Committee on Immunization Practices)," lead author Dr. Philip L. Gould and his associates write.
In June 2006, the ACIP recommended a second dose of varicella vaccine for children at age of school-entry and a catch-up second dose for all ages. According to the authors, an outbreak of chickenpox at the school in Arkansas was the first chance to investigate the effectiveness of this second dose. They note that the outbreak was the largest reported in recent years in the US.
Children were considered vaccinated if their first or second dose was received at least 42 days before rash onset. Among children with no history of varicella, vaccination coverage was 97% for at least one dose and 39% for the second dose. In addition, the report indicates, 15% had a positive history for varicella.
There were 84 cases of varicella between September 1 and December 18. Twenty-five cases had received two doses, 53 had received one dose, and 6 were unvaccinated with a history of the disease. Overall disease severity was mild, the authors note.
Dr. Gould, from the Centers for Disease Control and Prevention in Atlanta, and his team estimated vaccine effectiveness as 85.4% for one dose and 89.1% for two doses, not a significant difference. The vaccine was 100% effective against severe disease.
"It is possible," they contend, "that higher two-dose coverage at the school would have prevented the second outbreak from occurring, or that high coverage with two doses of varicella vaccine will reduce the number of outbreaks in the population."
Pediatr Infect Dis J 2009;28:678-681.
(Reuters Health) Aug 12 - During an outbreak of varicella in an elementary school in Arkansas, students who were vaccinated once or twice still came down with the illness, though their symptoms were mild.
Furthermore, vaccine effectiveness was no better among those who received two inoculations prior to the outbreak than those who received only one, researchers report in the Pediatric Infectious Disease Journal for August.
"As our understanding of the effectiveness of one dose of varicella has developed (with) postlicensure studies, additional studies will be needed to assess the impact of the routine two-dose recommendation by the ACIP (Advisory Committee on Immunization Practices)," lead author Dr. Philip L. Gould and his associates write.
In June 2006, the ACIP recommended a second dose of varicella vaccine for children at age of school-entry and a catch-up second dose for all ages. According to the authors, an outbreak of chickenpox at the school in Arkansas was the first chance to investigate the effectiveness of this second dose. They note that the outbreak was the largest reported in recent years in the US.
Children were considered vaccinated if their first or second dose was received at least 42 days before rash onset. Among children with no history of varicella, vaccination coverage was 97% for at least one dose and 39% for the second dose. In addition, the report indicates, 15% had a positive history for varicella.
There were 84 cases of varicella between September 1 and December 18. Twenty-five cases had received two doses, 53 had received one dose, and 6 were unvaccinated with a history of the disease. Overall disease severity was mild, the authors note.
Dr. Gould, from the Centers for Disease Control and Prevention in Atlanta, and his team estimated vaccine effectiveness as 85.4% for one dose and 89.1% for two doses, not a significant difference. The vaccine was 100% effective against severe disease.
"It is possible," they contend, "that higher two-dose coverage at the school would have prevented the second outbreak from occurring, or that high coverage with two doses of varicella vaccine will reduce the number of outbreaks in the population."
Pediatr Infect Dis J 2009;28:678-681.
Saturday, September 12, 2009
Flu Drugs Little Use for Children, UK Study Says
From Reuters Health Information
LONDON (Reuters) Aug 10 - Children should not routinely be given influenza drugs such as Tamiflu since there is no clear evidence they prevent complications and potentially harmful side effects may outweigh any benefits, British researchers said on Monday.
"While morbidity and mortality in the current pandemic remain low, a more conservative strategy might be considered prudent, given the limited data, side effects such as vomiting, and the potential for developing resistant strains of influenza," they said.
Governments around the world have built up stockpiles of Roche's Tamiflu and GlaxoSmithKline's Relenza to deal with the current H1N1 swine flu pandemic.
In Britain, hundreds of thousands of doses of Tamiflu have been handed out to people with the disease, of whom around half are children.
But Matthew Thompson from the University of Oxford and colleagues reported in the British Medical Journal that while antivirals shortened the duration of flu in children by around a day, they didn't reduce asthma flare-ups or the likelihood of children needing antibiotics.
Tamiflu was also linked to an increased risk of vomiting, which can be serious in children.
The analysis was based on a systematic review of seven previous clinical studies looking at use of Tamiflu and Relenza in seasonal flu outbreaks in children aged 1 to 12 years.
Thompson told reporters there was no reason to think the conclusions would not also apply to the current relatively mild outbreak of swine flu.
SOURCE: BMJ, online first August 10, 2009.
LONDON (Reuters) Aug 10 - Children should not routinely be given influenza drugs such as Tamiflu since there is no clear evidence they prevent complications and potentially harmful side effects may outweigh any benefits, British researchers said on Monday.
"While morbidity and mortality in the current pandemic remain low, a more conservative strategy might be considered prudent, given the limited data, side effects such as vomiting, and the potential for developing resistant strains of influenza," they said.
Governments around the world have built up stockpiles of Roche's Tamiflu and GlaxoSmithKline's Relenza to deal with the current H1N1 swine flu pandemic.
In Britain, hundreds of thousands of doses of Tamiflu have been handed out to people with the disease, of whom around half are children.
But Matthew Thompson from the University of Oxford and colleagues reported in the British Medical Journal that while antivirals shortened the duration of flu in children by around a day, they didn't reduce asthma flare-ups or the likelihood of children needing antibiotics.
Tamiflu was also linked to an increased risk of vomiting, which can be serious in children.
The analysis was based on a systematic review of seven previous clinical studies looking at use of Tamiflu and Relenza in seasonal flu outbreaks in children aged 1 to 12 years.
Thompson told reporters there was no reason to think the conclusions would not also apply to the current relatively mild outbreak of swine flu.
SOURCE: BMJ, online first August 10, 2009.
Friday, September 11, 2009
HPV Vaccines: Cervarix Approval and Gardasil Use in Boys/Men Recommended by FDA Advisory Committee
From Medscape Medical News
Zosia Chustecka
September 11, 2009 — A second vaccine against human papillomavirus (HPV) for the prevention of cervical cancer — GlaxoSmithKline's Cervarix — has been recommended for approval in the United States; the extended use of Merck & Co's Gardasil, the first vaccine, was recommended for boys and men for the prevention of genital warts.
The recommendations came from the US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee. In both cases, the voting was almost unanimously in favor, with only 1 abstention or no vote, but the meeting heard concerns about the safety of the vaccines and questions about the public-health value of the extended indication.
The voting on Cervarix was carried out by 13 members of the committee. There were 12 votes in favor of and 1 vote against the data supporting its efficacy in preventing precancerous lesions and cervical cancer in females in the 15 to 25 year age group and, from immunobridging studies, the 10 to 14 year age group. One member left the meeting before the vote on safety, but 11 of the remaining members voted in favor of the data supporting the safety of Cervarix in this population; there was 1 vote against.
Eight members of the committee voted on Gardasil use in boys and men. The vote was 7 in favor of the efficacy data supporting the use of Gardasil in males 9 to 25 years of age for the indication of preventing genital warts; there was 1 abstention. The vote was also 7 in favor of the data supporting the safety of Gardasil in this population; there was 1 vote against.
The FDA usually — but not always — follows the recommendations of its advisory committees.
Second Vaccine for Cervical Cancer
If approved, Cervarix would be the second HPV vaccine available in the United States. It is already marketed in more than 100 countries worldwide, including the 27 member states of the European Union. This product has been used in nationwide vaccination programs in the United Kingdom and Australia since it was first approved in 2007. At the meeting, the manufacturer estimated that around 7 million doses have been distributed worldwide.
Ceravix is a bivalent vaccine, active against HPV types 16 and 18, which together are thought to be responsible for about 70% of all cervical cancer cases. However, data from clinical trials presented at the committee meeting suggested that the vaccine also offers protection against other virus types responsible for causing cervical cancer, including HPV types 31, 33, and 45, the next most common cancer-causing strains. In addition, the data presented showed a duration of immunity of 6.4 years.
In contrast, Gardasil is a quadrivalent vaccine with activity against 4 HPV types: HPV types 16 and 18, which cause cervical cancer, and HPV types 6 and 11, which cause genital warts. This extra activity means that this vaccine is also indicated for the prevention of genital warts in girls and women, and it has now been recommended for that same indication for boys and men. However, the current data on Gardasil in males extends only out 2 to 3 years, and in women extends only out 5 years.
Is Cervarix Better at Protecting Against Cervical Cancer?
The main purpose behind the development of these HPV vaccines was to prevent cervical cancer, and for this indication, Cervarix is the better of the 2 vaccines, said Diane Harper, MD, from the University of Missouri–Kansas City School of Medicine. She has been involved in clinical trials with both vaccines, and was approached by Medscape Oncology for comment.
Dr. Harper outlined the following reasons for her opinion:
Cervarix and Gardasil are equally effective for HPV types 16 and 18 in women with no previous HPV, but Cervarix has proven to have a longer duration than Gardasil (6.4 vs 5 years);
there are still no data on how long the protection will ultimately last, and whether booster shots will be needed.
Cervarix offers cross protection for 5 cervical-cancer-causing types of HPV, whereas Gardasil offers cross protection for 3. In addition, Cervarix offers protection against the 3 most common types of HPV that cause adenocarcinoma, which is very difficult to detect with Pap testing; Gardasil is deficient in 1 of those types.
Cervarix prevents nearly twice the number of excisional therapies as does Gardasil (70% vs 40%), which is one of the harms that Pap screening can cause (excisional therapies lead to reproductive morbidity).
The antibody titers induced by Cervarix are superior to those for Gardasil, and are superior for women older than 25 years, should there come a time when the vaccines are approved for optional use by women in this age group. The antibody titers in the cervical mucous are also superior with Cervarix, and it is in the mucous on the epithelial surface that "half the action happens."
"I realize that this may sound like an advertisement for Cervarix, but these are the facts" Dr. Harper explained. "If you bother to vaccinate in countries with screening, then you want to vaccinate with the vaccine that will offer you the greatest cancer protection," she said.
Voting Against the Vaccines
The votes against both vaccines came from the consumer representative on the committee, Vicky Debold, PhD, RN, director of patient safety at the National Vaccine Information Center. She told Medscape Oncology that she has concerns about the safety of these vaccines, and acknowledged that her view is colored by listening to reports of adverse events from members of the public, in particular parents whose daughters who have suffered after vaccination with Gardasil.
"I'm not quite sure what is going on, but there have been too many patients with problems," she said. "There have been reports of demyelinating conditions and also deaths, and I wonder if there is a tendency toward a hyperstimulating of the immune system that results in such catastrophic outcomes." She suspects that there are individuals who might be particularly susceptible to adverse effects, maybe because of pre-existing conditions or genetic vulnerability.
It is very difficult to assess the safety of vaccines, Dr. Debold noted. At the meeting, she pointed out that, in many cases, the trials of both vaccines did not use a true placebo, such as a saline injection. The trials of Gardasil used an adjuvant control, and some of the Cervarix studies used hepatitis A vaccine as the control. "This makes the data very confusing," she said.
In addition, Dr. Debold had an issue with the way the question on the efficacy of Cervarix was worded. She felt the data showed that the vaccine did prevent precancerous lesions (and she would have voted yes for that), but the question also included wording about the prevention of cervical cancer, "and the data do not show this, not yet. The implication is that by preventing the earlier lesions, you prevent cervical cancer, but that is an implication, it has not been shown," she said.
At the meeting, specific questions about the safety of Cervarix focused on an "imbalance" of reports of spontaneous abortions and autoimmune adverse effects, but experts at the meeting were not convinced that these reports were related to the vaccine, with 1 commenting that "there are quirks in the collection of data."
Other Benefits From the Vaccines
Another potential benefit from a vaccine such as Gardasil that is active against HPV types 6 and 11 is that it might also offer protection against other "warty" diseases, including juvenile respiratory papillomatosis. Speaking during the open part of the meeting, Craig Derkay, MD, pediatric otolaryngologistat the Eastern Virginia Medical School in Norfolk, noted that there are about 1500 new cases each year of laryngeal papilloma caused by HPV 6 and 11, with the infection usually acquired from the mother during passage through the birth canal. There are no adjuvant therapies for this disease, and surgery is often not curative, he said. A vaccine that targets HPV 6 and 11 could "substantially reduce" this disease burden, and might also prevent HPV-associated head and neck cancer. If an HPV vaccine is to be used, it is preferable to use one with the broader spectrum so as to also prevent these types of diseases, he said.
Also speaking in the open part of the meeting was Dianne Zuckerman, PhD, president of the National Research Center for Women and Families. She expressed concern about the lack of long-term efficacy data for Gardasil in boys and men. The trial data that were presented were for 2 years, but some of the seroconversion data were for only 7 months, she pointed out.
The boys of America are not facing an epidemic of genital warts.
The whole point of vaccinating boys 9 to 11 years old is to protect them from genital warts once they become sexually active, but some of the data showed that the antibody titers dropped off during the 2 years of the trial, which raises the concern that any protection offered by the vaccine could have worn off by the time these boys become sexually active. "The boys of America are not facing an epidemic of genital warts and we have time to wait for efficacy data," she said.
In addition, she pointed out that genital warts are not life-threatening, and the male genital cancers that the vaccine offers protection against, such as penile and anal cancer, are very rare in heterosexual men.
One of the committee members highlighted the natural history of genital warts, which he felt was important for the discussion. "While they are ugly and a nuisance, they are also self-limiting and will go away on their own in individuals with a normal immune system," he said.
Approached for comment, Maurie Markman, MD, professor of gynecologic medical oncology at the University of Texas MD Anderson Cancer Center in Houston, who is an editorial advisor for Medscape Oncology, said: "I suspect evidence supporting the protection of males from genital warts will need to be very strong for the FDA to approve [this indication]. There is a very strong theoretical rationale to support vaccination of males to prevent cervix cancer in women, but considering the current cost of vaccination, I would seriously question the cost-effectiveness of this approach, at least in the United States. Further, there may be genuine protection of males against the risk of head and neck and other uncommon cancers, but again, this will need to be demonstrated in the clinical-trials setting."
Also during the open part of the meeting, there were testimonials from 2 mothers whose daughters had suffered adverse effects after vaccination with Gardasil, one of whom died shortly after her third dose. One of these mothers suggested that there was a link between niacin deficiency and adverse reactions to the HPV vaccine, and that individuals with pyruvate kinase deficiency might be particularly susceptible.
Paradigm-Shifting Prevention Strategy
Speaking out in favor of HPV vaccination — indeed, describing it as a "paradigm-shifting prevention strategy for cervical cancer" — was Mark Einstein, MD, MS, director of clinical research for women's health and gynecologic oncology at the Albert Einstein College of Medicine, in the Bronx, New York; he was representing the Society of Gynecologic Oncologists.
Cervical cancer remains a clinically relevant problem with in the United States, he told the meeting, with 11,000 new cases diagnosed annually, and about half a million women affected annually by precancerous lesions that could affect their reproductive health.
"The public-health value of the protection afforded by HPV vaccination overwhelmingly outweighs the self-limiting local side effects and even the rare but more serious effects that may or may not be vaccine-related," he told the meeting.
Zosia Chustecka is news editor for Medscape Hematology-Oncology and prior news editor of jointandbone.org, a Web site acquired by WebMD. A veteran medical journalist based in London, UK, she has won a prize from the British Medical Journalists Association and is a pharmacology graduate. She has written for a wide variety of publications aimed at the medical and related health professions. She can be contacted at ZChustecka@webmd.net.
Zosia Chustecka
September 11, 2009 — A second vaccine against human papillomavirus (HPV) for the prevention of cervical cancer — GlaxoSmithKline's Cervarix — has been recommended for approval in the United States; the extended use of Merck & Co's Gardasil, the first vaccine, was recommended for boys and men for the prevention of genital warts.
The recommendations came from the US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee. In both cases, the voting was almost unanimously in favor, with only 1 abstention or no vote, but the meeting heard concerns about the safety of the vaccines and questions about the public-health value of the extended indication.
The voting on Cervarix was carried out by 13 members of the committee. There were 12 votes in favor of and 1 vote against the data supporting its efficacy in preventing precancerous lesions and cervical cancer in females in the 15 to 25 year age group and, from immunobridging studies, the 10 to 14 year age group. One member left the meeting before the vote on safety, but 11 of the remaining members voted in favor of the data supporting the safety of Cervarix in this population; there was 1 vote against.
Eight members of the committee voted on Gardasil use in boys and men. The vote was 7 in favor of the efficacy data supporting the use of Gardasil in males 9 to 25 years of age for the indication of preventing genital warts; there was 1 abstention. The vote was also 7 in favor of the data supporting the safety of Gardasil in this population; there was 1 vote against.
The FDA usually — but not always — follows the recommendations of its advisory committees.
Second Vaccine for Cervical Cancer
If approved, Cervarix would be the second HPV vaccine available in the United States. It is already marketed in more than 100 countries worldwide, including the 27 member states of the European Union. This product has been used in nationwide vaccination programs in the United Kingdom and Australia since it was first approved in 2007. At the meeting, the manufacturer estimated that around 7 million doses have been distributed worldwide.
Ceravix is a bivalent vaccine, active against HPV types 16 and 18, which together are thought to be responsible for about 70% of all cervical cancer cases. However, data from clinical trials presented at the committee meeting suggested that the vaccine also offers protection against other virus types responsible for causing cervical cancer, including HPV types 31, 33, and 45, the next most common cancer-causing strains. In addition, the data presented showed a duration of immunity of 6.4 years.
In contrast, Gardasil is a quadrivalent vaccine with activity against 4 HPV types: HPV types 16 and 18, which cause cervical cancer, and HPV types 6 and 11, which cause genital warts. This extra activity means that this vaccine is also indicated for the prevention of genital warts in girls and women, and it has now been recommended for that same indication for boys and men. However, the current data on Gardasil in males extends only out 2 to 3 years, and in women extends only out 5 years.
Is Cervarix Better at Protecting Against Cervical Cancer?
The main purpose behind the development of these HPV vaccines was to prevent cervical cancer, and for this indication, Cervarix is the better of the 2 vaccines, said Diane Harper, MD, from the University of Missouri–Kansas City School of Medicine. She has been involved in clinical trials with both vaccines, and was approached by Medscape Oncology for comment.
Dr. Harper outlined the following reasons for her opinion:
Cervarix and Gardasil are equally effective for HPV types 16 and 18 in women with no previous HPV, but Cervarix has proven to have a longer duration than Gardasil (6.4 vs 5 years);
there are still no data on how long the protection will ultimately last, and whether booster shots will be needed.
Cervarix offers cross protection for 5 cervical-cancer-causing types of HPV, whereas Gardasil offers cross protection for 3. In addition, Cervarix offers protection against the 3 most common types of HPV that cause adenocarcinoma, which is very difficult to detect with Pap testing; Gardasil is deficient in 1 of those types.
Cervarix prevents nearly twice the number of excisional therapies as does Gardasil (70% vs 40%), which is one of the harms that Pap screening can cause (excisional therapies lead to reproductive morbidity).
The antibody titers induced by Cervarix are superior to those for Gardasil, and are superior for women older than 25 years, should there come a time when the vaccines are approved for optional use by women in this age group. The antibody titers in the cervical mucous are also superior with Cervarix, and it is in the mucous on the epithelial surface that "half the action happens."
"I realize that this may sound like an advertisement for Cervarix, but these are the facts" Dr. Harper explained. "If you bother to vaccinate in countries with screening, then you want to vaccinate with the vaccine that will offer you the greatest cancer protection," she said.
Voting Against the Vaccines
The votes against both vaccines came from the consumer representative on the committee, Vicky Debold, PhD, RN, director of patient safety at the National Vaccine Information Center. She told Medscape Oncology that she has concerns about the safety of these vaccines, and acknowledged that her view is colored by listening to reports of adverse events from members of the public, in particular parents whose daughters who have suffered after vaccination with Gardasil.
"I'm not quite sure what is going on, but there have been too many patients with problems," she said. "There have been reports of demyelinating conditions and also deaths, and I wonder if there is a tendency toward a hyperstimulating of the immune system that results in such catastrophic outcomes." She suspects that there are individuals who might be particularly susceptible to adverse effects, maybe because of pre-existing conditions or genetic vulnerability.
It is very difficult to assess the safety of vaccines, Dr. Debold noted. At the meeting, she pointed out that, in many cases, the trials of both vaccines did not use a true placebo, such as a saline injection. The trials of Gardasil used an adjuvant control, and some of the Cervarix studies used hepatitis A vaccine as the control. "This makes the data very confusing," she said.
In addition, Dr. Debold had an issue with the way the question on the efficacy of Cervarix was worded. She felt the data showed that the vaccine did prevent precancerous lesions (and she would have voted yes for that), but the question also included wording about the prevention of cervical cancer, "and the data do not show this, not yet. The implication is that by preventing the earlier lesions, you prevent cervical cancer, but that is an implication, it has not been shown," she said.
At the meeting, specific questions about the safety of Cervarix focused on an "imbalance" of reports of spontaneous abortions and autoimmune adverse effects, but experts at the meeting were not convinced that these reports were related to the vaccine, with 1 commenting that "there are quirks in the collection of data."
Other Benefits From the Vaccines
Another potential benefit from a vaccine such as Gardasil that is active against HPV types 6 and 11 is that it might also offer protection against other "warty" diseases, including juvenile respiratory papillomatosis. Speaking during the open part of the meeting, Craig Derkay, MD, pediatric otolaryngologistat the Eastern Virginia Medical School in Norfolk, noted that there are about 1500 new cases each year of laryngeal papilloma caused by HPV 6 and 11, with the infection usually acquired from the mother during passage through the birth canal. There are no adjuvant therapies for this disease, and surgery is often not curative, he said. A vaccine that targets HPV 6 and 11 could "substantially reduce" this disease burden, and might also prevent HPV-associated head and neck cancer. If an HPV vaccine is to be used, it is preferable to use one with the broader spectrum so as to also prevent these types of diseases, he said.
Also speaking in the open part of the meeting was Dianne Zuckerman, PhD, president of the National Research Center for Women and Families. She expressed concern about the lack of long-term efficacy data for Gardasil in boys and men. The trial data that were presented were for 2 years, but some of the seroconversion data were for only 7 months, she pointed out.
The boys of America are not facing an epidemic of genital warts.
The whole point of vaccinating boys 9 to 11 years old is to protect them from genital warts once they become sexually active, but some of the data showed that the antibody titers dropped off during the 2 years of the trial, which raises the concern that any protection offered by the vaccine could have worn off by the time these boys become sexually active. "The boys of America are not facing an epidemic of genital warts and we have time to wait for efficacy data," she said.
In addition, she pointed out that genital warts are not life-threatening, and the male genital cancers that the vaccine offers protection against, such as penile and anal cancer, are very rare in heterosexual men.
One of the committee members highlighted the natural history of genital warts, which he felt was important for the discussion. "While they are ugly and a nuisance, they are also self-limiting and will go away on their own in individuals with a normal immune system," he said.
Approached for comment, Maurie Markman, MD, professor of gynecologic medical oncology at the University of Texas MD Anderson Cancer Center in Houston, who is an editorial advisor for Medscape Oncology, said: "I suspect evidence supporting the protection of males from genital warts will need to be very strong for the FDA to approve [this indication]. There is a very strong theoretical rationale to support vaccination of males to prevent cervix cancer in women, but considering the current cost of vaccination, I would seriously question the cost-effectiveness of this approach, at least in the United States. Further, there may be genuine protection of males against the risk of head and neck and other uncommon cancers, but again, this will need to be demonstrated in the clinical-trials setting."
Also during the open part of the meeting, there were testimonials from 2 mothers whose daughters had suffered adverse effects after vaccination with Gardasil, one of whom died shortly after her third dose. One of these mothers suggested that there was a link between niacin deficiency and adverse reactions to the HPV vaccine, and that individuals with pyruvate kinase deficiency might be particularly susceptible.
Paradigm-Shifting Prevention Strategy
Speaking out in favor of HPV vaccination — indeed, describing it as a "paradigm-shifting prevention strategy for cervical cancer" — was Mark Einstein, MD, MS, director of clinical research for women's health and gynecologic oncology at the Albert Einstein College of Medicine, in the Bronx, New York; he was representing the Society of Gynecologic Oncologists.
Cervical cancer remains a clinically relevant problem with in the United States, he told the meeting, with 11,000 new cases diagnosed annually, and about half a million women affected annually by precancerous lesions that could affect their reproductive health.
"The public-health value of the protection afforded by HPV vaccination overwhelmingly outweighs the self-limiting local side effects and even the rare but more serious effects that may or may not be vaccine-related," he told the meeting.
Zosia Chustecka is news editor for Medscape Hematology-Oncology and prior news editor of jointandbone.org, a Web site acquired by WebMD. A veteran medical journalist based in London, UK, she has won a prize from the British Medical Journalists Association and is a pharmacology graduate. She has written for a wide variety of publications aimed at the medical and related health professions. She can be contacted at ZChustecka@webmd.net.
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