Hayes, Inc. launches Genetic Test Evaluation (GTE), a subscription-based, online service that provides insurers, hospitals and policy makers objective insight into the clinical utility of genetic tests. Hayes GTE is a powerful tool designed to sort through the entanglement of information and clinical trial data surrounding the more than 1200 genetic tests that are currently available to doctors and patients.
"As these tests come to the forefront of diagnosis and treatment of disease, there are many questions regarding their accuracy, validity, and clinical utility," says Winifred S. Hayes, PhD, president and CEO of the company. "Hayes GTE provides a clear, objective view of the science behind these tests, the hard clinical evidence supporting them, and the use of the tests in clinical practice."
The clinical, ethical, and financial implications of these tests are broad and pressing. Hayes GTE is the first evidence-based service to address these issues through application of the Hayes Rating, a proprietary system that is a standard in the industry. The evidence behind each test is critically appraised to evaluate the analytical validity, clinical validity, and clinical utility. Ratings range from "A, Established Benefit," meaning that there is good evidence that the test has validity and utility, to "D, No Proven Benefit," which means that the test lacks validity or utility, or that there is insufficient evidence to evaluate the test.
"Millions of dollars are being spent on genetic tests by hospitals and insurers, and by consumers," says Dr. Hayes. "But our initial analysis indicates that the evidence is insufficient to substantiate the clinical validity and utility of many of these tests, despite their increasing use." In fact, the Hayes international team of medical analysts found inadequate evidence for some of the most widely used genetic tests for breast cancer, including Mammostrat, MammaPrint, Oncotype DX, and Rotterdam Signature, which all received Hayes Ratings of C or lower.
"Just as disconcerting," says Dr. Hayes, "is that many of these tests suggest a correlation to disease, which could unnecessarily cause concern among patients who may never develop the disease. In other cases, there may be no way to prevent or treat the disease, and it's unclear how the test result can be used to improve patient management. It's essential that these tests be used only when there is evidence that there will be some benefit to the patient."
Hayes GTE addresses these issues by providing independent, evidence-based assessments of genetic tests. These unbiased evaluations provide important information for insurers, hospitals, and policy makers to consider when making decisions regarding the use of these genetic tests in the clinical setting.
About Hayes, Inc.
Hayes, Inc. provides unbiased, evidence-based research and analysis to help insurers, hospitals, and policy makers make informed healthcare decisions. The company's conclusions are independent, impartial, and objective, formulated by an international staff of medical analysts drawn from a range of healthcare disciplines.
Hayes research products and advisory services are used by some of the world's leading healthcare organizations. More than 65% of U.S. healthcare insurers serving approximately 150 million lives depend on Hayes research when developing coverage policies. In addition, Hayes research also supports hospitals making health technology acquisition decisions and employers helping employees make better informed healthcare choices.
Hayes, Inc. was founded by Winifred S. Hayes, PhD, in 1989 and is headquartered in suburban Philadelphia.
Hayes, Inc.
Targanta Therapeutics Corporation
today released detailed data from completed studies comparing the in vitro
activity of its lead antibiotic drug candidate, oritavancin, to that of
other antibiotics against a variety of susceptible and resistant strains of
gram positive bacteria. Results are being presented today at the 47th
Annual Interscience Conference on Antimicrobial Agents and Chemotherapy
(ICAAC) taking place in Chicago, IL. All posters highlighted below are
being presented at 12:15 pm CDT.
Poster E-1617 is entitled "In Vitro Activity Profile of Oritavancin
(ORI) Against Resistant Staphylococcal Populations From a Recent
Surveillance Initiative." In this study, researchers examined clinical
isolates of Staphylococcus aureus (n=5,008) and coagulase-negative
staphylococci (n=862) collected in 2005-2006 from hospital sites in the
U.S., Europe and Israel. Oritavancin was active against all staphylococcal
isolates, including those with specific resistance phenotypes and including
multi-drug resistant S. aureus, which were resistant to three or more of
the following agents: ciprofloxacin, clindamycin, erythromycin, gentamicin,
oxacillin, quinupristin- dalfopristin, trimethoprim-sulfa, vancomycin,
daptomycin, and linezolid. Results from this study demonstrated that
oritavancin had potent in vitro activity against a wide spectrum of
staphylococci likely to be encountered in a variety of clinical settings.
Poster E-1613, entitled "In Vitro Activity Profile of Oritavancin (ORI)
Against Organisms Demonstrating Key Resistance Profiles to Other
Antimicrobial Agents," compared the activity of oritavancin to vancomycin
and teicoplanin against a diverse collection of staphylococci and
enterococci, including strains with elevated MICs to linezolid, daptomycin,
and/or vancomycin, as well as strains of streptococci. Bacterial isolates
included S. aureus (n=35), coagulase-negative staphylococci (n=21),
Enterococcus faecalis (n=11), Enterococcus faecium (n=32), Streptococcus
pneumoniae (n=20) and Streptococcus pyogenes (n=20). Data from the study
revealed that oritavancin demonstrated potent in vitro activity against
geographically diverse, contemporary gram- positive pathogens with
important resistance phenotypes and genotypes.
The study presented in poster E-1615, entitled "Anti-Enterococcal
Activity Profile of Oritavancin, a Potent Lipoglycopeptide under
Development for Use Against Gram-Positive Infections," established a
current in vitro activity profile of oritavancin against both E. faecalis
and E. faecium populations, including strains resistant to linezolid,
daptomycin, and vancomycin. In the study, oritavancin showed potent in
vitro activity against all enterococci encountered in this study, including
strains non-susceptible to vancomycin (both VanA and VanB phenotypes),
linezolid or daptomycin.
Poster E-1619, entitled "Synergistic Effects of Oritavancin Tested in
Combination with Other Agents," details a study that tested for synergistic
activity of oritavancin when combined with other antibiotics against S.
aureus and enterococci of different resistance phenotypes. Oritavancin was
tested in combination with daptomycin, gentamicin, linezolid, moxifloxacin
or rifampicin against methicillin-sensitive S. aureus (MSSA), a clinical
isolate of vancomycin-intermediate S. aureus (VISA), vancomycin-resistant
S. aureus (VRSA), vancomycin-resistant E. faecium (VanA VRE), and
vancomycin-resistant E. faecalis (VanB VRE). The study demonstrated that
oritavancin has promising activity in vitro in combination as it synergizes
with antibiotics of different classes against gram-positive pathogens of
clinically important resistance phenotypes.
In poster E-1620, entitled "Pharmacokinetic Concentrations of
Oritavancin Kill Stationary-Phase and Biofilm Staphylococcus aureus In
Vitro," researchers detailed the antibacterial efficacy of physiologically
attainable concentrations of oritavancin and other comparators tested
against in vitro models of slow-growing and biofilm S. aureus. Slow-growing
bacteria and biofilms are notoriously tolerant to antibiotics. In this
study, time-kill studies were performed using oritavancin, linezolid and
vancomycin on stationary-phase MSSA, methicillin-resistant S. aureus (MRSA)
and VRSA. Under the conditions of these in vitro assays, oritavancin
displayed concentration- dependent bactericidal activity against all three
S. aureus inocula whereas comparator agents vancomycin and linezolid
displayed bacteriostatic activity. Against the S. aureus biofilms,
oritavancin exhibited minimal biofilm eradication concentrations (MBEC)
values between 0.5 and 2 microgram/mL, whereas linezolid and vancomycin
were ineffective (MBEC greater than 128 microgram/mL). The study concluded
that pharmacokinetic concentrations of oritavancin show promising activity
in vitro against stationary-phase and biofilm S. aureus of clinically
important resistance phenotypes.
Poster E-1614 is entitled "In vitro Time Kill Studies of Oritavancin
against Drug-resistant Isolates of Staphylococcus aureus and Enterococci."
To understand the time dependence of oritavancin activity, in vitro
time-kill experiments were completed against clinically important strains
of S. aureus, E. faecalis, and E. faecium, including recently identified
antibiotic- resistant isolates. In this study, oritavancin displayed
concentration- dependent killing of MSSA, MRSA, VRSA, VISA, VSE and both
VanA and VanB strains of VRE in vitro. In addition, oritavancin was more
rapidly bactericidal in this in vitro study against all bacteria tested
than were vancomycin, teicoplanin, linezolid or daptomycin at their
respective physiologically relevant concentrations.
Additional oritavancin-related posters presented today at ICAAC include:
-- In Vitro Activity Profile of Oritavancin against a Broad Spectrum of
Aerobic and Anaerobic Bacterial Pathogens (E-1612, 12:15 p.m. CDT)
-- Anti-Streptococcal Activity Profile of Oritavancin, a Potent
Lipoglycopeptide under Development for Use Against Gram-Positive
Infections (E-1616, 12:15 p.m. CDT)
-- Comparative Intracellular Activity of 10 Anti-Staphylococcal
Antibiotics (AABs) Against a Stable Small Colony Variant (SCV) of S.
aureus in a Model of Human THP-1 Macrophages (A-1437, 1:15 p.m. CDT)
About Oritavancin
Oritavancin is a novel semi-synthetic lipoglycopeptide antibiotic
candidate with potent bactericidal (killing) activity against a broad
spectrum of gram-positive bacteria. The product candidate has been tested
in over 1500 patients and has completed two Phase 3 studies for the
treatment of complicated skin and skin structure infections (cSSSI) in
which the primary endpoints were met. Targanta believes oritavancin's
properties may give it distinct advantages over currently marketed
therapies and expects to submit a New Drug Application to the U.S. Food and
Drug Administration in the first quarter of 2008 seeking to commercialize
oritavancin for the treatment of cSSSI.
About Targanta Therapeutics
Targanta Therapeutics Corporation is a privately held biopharmaceutical
company focused on developing and commercializing innovative antibiotics to
treat serious infections in the hospital and other institutional settings.
The Company's pipeline includes oritavancin, a semi-synthetic
lipoglycopeptide antibiotic, for which Targanta intends to seek U.S.
regulatory approval in early 2008, as well as a number of antibacterial
agents in pre-clinical development. The company has operations in
Cambridge, MA, Indianapolis, IN, Montreal, Quebec, Canada and Toronto,
Ontario, Canada. For further information about Targanta, visit the
company's website at targanta.
Disclaimer
All forward-looking statements and other information included in this
press release are based on information available to Targanta as of the date
hereof, and Targanta assumes no obligation to update any such
forward-looking statements or information. Targanta's actual results could
differ materially from those described in Targanta's forward-looking
statements.
Targanta Therapeutics Corporation
targanta
View drug information on Clindamycin phosphate topical gel.
Continued increases-as much as 15 percent-were made in nationwide coverage for vaccines specifically recommended for pre-teens, according to 2009 National Immunization Survey-Teen (NIS-Teen) estimates released by the Centers for Disease Control and Prevention.
The survey of more than 20,000 teens aged 13-17 found that in 2009 there were increases in the percentage of teens in this age group who had received vaccines routinely recommended for 11- and 12-year-olds. Specifically:
- For one dose of the tetanus-diphtheria-acellular pertussis vaccine (Tdap), coverage went up about 15 points to about 56 percent;
- For one dose of meningococcal conjugate vaccine, coverage went up about 12 points to about 54 percent;
- For girls who received at least one dose of human papillomavirus (HPV) vaccine, coverage increased 7 points to about 44 percent. However, for girls who received the recommended three doses of HPV vaccine, coverage was only about 27 percent (a 9 percent increase);
- For one dose of HPV vaccine, no differences were observed between racial/ethnic groups. However, coverage was higher among teens living in poverty compared with those living at or above the poverty level. For the recommended three doses of HPV vaccine, differences were observed between racial/ethnic groups, including significantly lower coverage for blacks and Hispanics compared to whites;
- There were no significant differences in coverage by racial/ethnic group or by poverty status for Tdap or meningococcal conjugate vaccine; and
- As in 2008, there was wide variation in adolescent vaccination coverage among state and local areas.
"This year's data are mixed," said Anne Schuchat, M.D., director of CDC's National Center for Immunization and Respiratory Diseases. "We can see that more parents of adolescents are electing to protect their children from serious diseases such as pertussis, meningitis, and cervical cancer, but there is clear room for improvement in our system's ability to reach this age group."
"Pertussis outbreaks in several states and an increase in pertussis-related infant deaths in California highlight how important it is for pre-teens to receive the Tdap booster," said Dr. Schuchat. "It is important for teens and adults to get a one-time dose of Tdap to protect themselves and those around them from whooping cough. Young infants are most vulnerable to serious complications from pertussis and can be infected by older siblings, parents or other caretakers."
The CDC encourages parents to talk with their child's health care provider to find out when to come in for recommended check-ups. "Completing the three-dose HPV vaccine series is very important to ensure protection against cervical cancer. Visits for immunization can be a great opportunity to address other important preventive issues that all teens need," Dr. Schuchat said.
Although poverty was not a barrier to receiving any of the three adolescent vaccines, financial challenges could prevent some teens from getting vaccinated. Families who need help paying for vaccines should ask their health care provider about the Vaccines for Children program, which provides free vaccines to uninsured children and many others with financial barriers. For help in finding a local health care provider who participates in the program, parents can call 800-CDC-INFO or go here.
The CDC has conducted the National Immunization Survey-Teen since 2006. It is similar to the standard NIS, which in 1994 began collecting immunization information among children 19 through 35 months old and is a random telephone survey of parents or care-givers, followed by verification of records with health care providers. The NIS-Teen estimates the proportion of teens aged 13 through 17 years who have received the three recommended pre-teen vaccines, as well as three of the recommended childhood vaccines, by the time they are surveyed.
Source:
CDC
University of Rochester researchers, who have been investigating new therapies for hot flashes for several years, report in the July Obstetrics and Gynecology journal that the seizure drug gabapentin is as effective as estrogen, which used to be the gold standard treatment for menopause symptoms.
Estrogen is no longer the preferred therapy because recent, large studies have shown that the hormone increases the risk of heart disease, stroke, breast cancer and Alzheimer's disease for some women. Given that news, millions of women have abandoned hormone replacement therapy (HRT) and are seeking other ways to ease symptoms. So-called natural remedies such as soy, herbal products or acupuncture have not proven safe or effective at this point.
The latest Rochester study is the first to compare gabapentin and estrogen head-to-head against a placebo. Although it showed a substantial placebo effect similar to other menopause studies - women taking the sugar pill reported a 54-percent reduction in hot flashes - the women taking gabapentin and estrogen reported even better results, with a 71 percent to 72 percent decline in symptoms.
"Gabapentin does appear to be as effective as estrogen," said lead author Sireesha Y. Reddy, M.D., assistant professor of Obstetrics and Gynecology at the University of Rochester Medical Center. "Until now its efficacy relative to estrogen was unknown."
Approximately 75 percent of postmenopausal women between the ages of 35 and 60 experience hot flashes. Gabapentin (sold under the trade name Neurontin) was approved by the FDA in 1994 to treat epileptic seizures but has been used off-label for years to treat headaches, shingles pain and other ailments. Scientists hypothesize that gabapentin may reduce hot flashes by regulating the flow of calcium in and out of cells, which is one mechanism for controlling body temperature.
An expert panel on menopause convened by the National Institutes of Health last year cautioned against the tendency to use treatments with scant safety data, and concluded that nothing to date was as effective as estrogen therapy although more research was needed.
In the latest study, Reddy and colleagues enrolled 60 women in a randomized, double-blind, placebo-controlled trial for 12 weeks. Initially the researchers received more than 1,500 calls from women who wanted to participate, but after screening the callers to meet the study's protocol, the number was whittled to 60, with 53 women complying with every step.
They were randomly divided into three groups: 20 women received gabapentin at 2,400 mg per day and a daily placebo or fake estrogen pill; 20 received estrogen in the form of Premarin at 0.625 mg per day and a fake gabapentin pill; 20 received sugar pills resembling gabapentin and estrogen. The women recorded the frequency and severity of their hot flashes in diaries.
Results were tabulated using two statistical methods to compare the women's hot flash reports throughout the 12-week period with their baseline symptoms. Doctors did find that women who took gabapentin complained more often of headaches, dizziness or disorientation. Researchers believe that slowly ramping up the medication and taking it with meals can alleviate the side effects.
###
The NIH funded the study. Pfizer Inc. supplied gabapentin but had no role in the research. A co-author on the paper, Thomas Guttuso Jr., M.D., has a patent for the use of gabapentin in the treatment of hot flashes. Guttuso is a former neurologist at the University of Rochester who is now on the faculty at the University of Buffalo.
Contact: Leslie Orr
University of Rochester Medical Center
View drug information on Neurontin; Premarin.
Isabelle Caro, a French model who posed naked for an anti-anorexia campaign died at the age of 28 after being treated for an acute respiratory illness. She died on November 17th after returning to France from a job in Tokyo, according to a friend, Vincent Bigler, a Swiss singer. In an announcement to journalists, Bigler added that he was not sure what the exact cause of death was. Caro's emaciated image shocked people during an Italian ad campaign aimed at highlighting the problems related to anorexia in the world of fashion and other parts of society. Caro was suffering from anorexia when she posed for the photograph and weighed 59 pounds (27 kilograms).
Anorexia Nervosa is a psychological disorder in which the patient has a distorted body image and an illogical fear of becoming/being fat, so they deliberately try to lose weight. The vast majority of sufferers are females, but men may also be sufferers.
According to DSM-IV-TR® Diagnostic and Statistical Manual of Mental Disorders (American Psychiatric Association), a patient with Anorexia Nervosa:
Weighs at least 15% less than their ideal weight
Has a body mass index (BMI) of no more than 17.5
Has missed three consecutive menstrual periods
Is over-preoccupied with weight and body shape
Is extremely fearful of gaining weight
In over ¾ of cases, Anorexia Nervosa starts when the patient is aged between 11 and 20 years. Approximately 6% of patients die, with half of all deaths resulting from suicide. Anorexia Nervosa has the highest mortality rate of all mental illnesses.
Sufferers are typically perfectionists who set themselves unattainable targets. When those targets are not achieved, the patients start controlling parts of their life they are able to, such as their food intake and body weight. Experts say that an irrational fear of losing control generally results from low-self esteem and self-criticism. Many patients feel they have totally lost control after eating a minute amount of food.
Caro's illness started when she was 13 years old.
Following the death of a Brazilian model from an eating disorder, Oliviero Toscani, an Italian photographer, created an advertising campaign for an Italian fashion company. Caro's nude picture appeared on billboards and newspapers - in the photograph her protruding bones and vertebrae were clearly visible. The ad's slogan read "No Anorexia".
Caro's photograph brought eating disorders into the limelight in Europe and North America. She spoke about her illness regularly and her efforts to get better. She explained how serious a menace anorexia was in the world of fashion.
Although the exact cause of death has not been revealed, Caro had been ill for a long time; she had been in and out of hospitals for several years.