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| The numbers are staggering. There are 6.2 million new cases reported in the United States every year. More than 50 percent of all sexually active people will contract it during their lifetimes. It is one of the most prevalent sexually transmitted diseases, but until recently, nobody was talking about the human papillomavirus (HPV).
Calling it an epidemic, Dr. Rachel Kramer, a doctor of obstetrics and gynecology at Emerson Hospital in Concord, said young women are particularly at risk for contracting HPV.
"I see so many young women who are devastated by HPV. They have no idea about it and they tell me they wish someone had told them. That's how we got into this epidemic - nobody talked about it," Kramer told a small group of residents at a talk sponsored by the Bedford Board of Health last week.
There are more than 100 types of HPV, including 40 that are sexually transmitted, Kramer said. Part of the problem with HPV is that it is often asymptomatic, Kramer said, or the symptoms go undetected until the infection has advanced. The most common symptom is genital warts, but HPV can also cause pre-carcinogenic lesions that can sometimes lead to cervical cancer in women. Most warts and lesions will regress within two years, but older women are more prone to persistent infections, which in turn puts them at higher risk for cancer, Kramer said.
Many people may be overlooking HPV, but the major pharmaceutical companies are not as two companies are currently seeking FDA approval for an HPV vaccine. In drug trials, Kramer said, the vaccine has been 90 percent effective in treating initial infections and nearly 100 percent effective in treating persistent infection. While there is cause for optimism, Kramer cautioned that approval of the vaccine may still be a long way off.
"There are a lot of questions about the vaccine and there are a lot of roads to go down before anybody has the answers," Kramer said.
Young women at highest risk
HPV is not the only STD affecting young women, however. According to Kramer, women between the ages of 15 and 24 have the highest rates of STDs, including common diseases such as gonorrhea, chlamydia, hepatitis C and herpes. Part of the reason for this trend, Kramer said, is that young women are more likely to have several sexual partners but are less likely to use condoms. Only 45 percent of sexually active adolescent girls reported using condoms, she said.
Most STDs also tend to have more serious long-term health consequences for women than for men. Untreated, STDs can cause fertility problems, pelvic inflammatory disease and cervical cancer in women, Kramer said.
As a result, Kramer said many standards in women's health are changing. In the past, it was recommended that a girl schedule her first appointment with a gynecologist at age 18, but Kramer said the new standard for a first visit is three years after becoming sexually active or 21, whichever comes first. Kramer said it may be a good idea for a young girl to speak with her doctor even before becoming sexually active. [continue] | | |
| (Pic)- Girl putting in contact lens in an undated photo from Yahoo Image Search.
NEW YORK (Reuters Health) - Investigators in Miami and San Francisco describe clusters of a serious eye infection called ulcerative keratitis, an ulceration of the cornea, among soft contact lens wearers caused by the fungus Fusarium, which until this year had been considered an unusual condition in the U.S. Reports of both clusters are published in the Archives of Ophthalmology.
An editorial note preceding the articles refers to the recent withdrawal by Bausch & Lomb of its ReNu MoistureLoc contact lens cleaner, because of an association with these infections. The note says those cases "appear to be part of a more global emergence of Fusarium as a vision-threatening organism in otherwise healthy patients."
In the first paper, Dr. Eduardo C. Alfonso and colleagues at the Bascom Palmer Eye Institute in Miami, report that their group treated 10 cases of soft contact lens-associated keratomycosis between 1969 and 1992. But between January 2004 and April 2006, they treated 34 cases attributed to Fusarium infection.
The average age of the patients was 34.9 years (range 13 to 92). Medical histories and evaluations failed to turn up any active disease that would predispose the patients to infectious ulceration.
Thirty-one patients (91 percent) were initially treated with antibiotics for presumed bacterial keratitis; four patients were treated with antiviral medications; and only two received antifungal therapy before the final diagnosis was made.
The average time from onset of symptoms to diagnosis was 9.1 days (range 0 to 140 days). At the initial examination, the size of the infiltrates ranged from 1 to 8 mm.
Once the fungus was identified, patients were usually treated with topical natamycin 5 percent and oral voriconazole 200 mg per day was prescribed to three patients. The length of treatment ranged from 21 to 138 days
One case required placement of tissue adhesive glue, and another required a surgical procedure. Most patients needed corneal scraping to remove dead tissue.
Alfonso's team cautions: "Based on the present report, ophthalmic clinicians should have a heightened clinical suspicion for possible Fusarium and other fungal pathogens as causative agents in cosmetic soft contact lens patients with ulcerative keratitis."
They note that cultures and microscopy are valuable diagnostic tools, and early treatment leads to rapid cure with good outcomes. They recommend a polyene antifungal agent, such as natamycin or amphotericin, applied every hour initially.
Meanwhile, in a small case series reported by Dr. David G. Hwang and associates at the University of California, San Francisco, there were four patients with contact lens-associated Fusarium keratitis during a 5-week span in early 2006. Previously, the department had treated eight cases of Fusarium keratitis between 1976 and 2005, only two of which were associated with contact lens use.
Three of the patients -- ages 19 to 24 years -- had no risk factors for fungal keratitis, whereas a fourth woman, 56 years old, was undergoing chemotherapy for non-Hodgkin lymphoma, which may have lowered her resistance to infection.
Initially two of the patients were misdiagnosed with herpes-related keratitis and the other two with bacterial keratitis. One patient whose diagnosis was not made for at least 4 weeks after symptom onset ended up requiring corneal transplant surgery. Seven weeks later, her visual acuity was still poor.
The other three patients recovered with visual acuity of 20/40 or better after treatment with topical antifungal therapy.
In many of the cases, but not all, patients recalled having used Bausch and Lomb contact lens solutions, which have been pulled from the market.
Hwang's team adds that clusters of cases have been reported in other areas of the U.S. and in Singapore.
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| Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc(NYSE: ELN) today announced the approval of a supplemental BiologicsLicense Application (sBLA) by the U.S. Food and Drug Administration(FDA) for the reintroduction of TYSABRI(R) (natalizumab) as amonotherapy treatment for relapsing forms of multiple sclerosis (MS)to slow the progression of disability and reduce the frequency ofclinical relapses. TYSABRI will be available upon the completion ofkey activities related to the risk management plan, including FDAreview of educational and training materials, internal validation ofsystems based on final FDA requirements and training of internalpersonnel. As such, the companies anticipate TYSABRI will be availablein July.
The FDA granted approval for reintroduction based on the review ofTYSABRI clinical trial data; revised labeling with enhanced safetywarnings; and a risk management plan (TOUCH Prescribing Program)designed to inform physicians and patients of the benefits and risksof TYSABRI treatment and minimize potential risk of progressivemultifocal leukoencephalopathy (PML). Because of the increased risk ofPML, TYSABRI monotherapy is generally recommended for patients whohave had an inadequate response to, or are unable to tolerate,alternate MS therapies.
"Today represents a significant step forward for people withrelapsing MS. The reintroduction of TYSABRI offers new hope as animportant therapeutic choice for patients living with this disablingdisease. TYSABRI has demonstrated compelling efficacy in MS, and webelieve the TOUCH Prescribing Program, designed in collaboration withthe FDA, will help patients and physicians assess the benefits andrisks of TYSABRI and make informed decisions about therapy," saidJames C. Mullen, Chief Executive Officer, Biogen Idec.
"We are pleased with the FDA's decision to once again make TYSABRIavailable to patients and their families suffering from this chronic,debilitating disease, " said Kelly Martin, Chief Executive Officer,Elan. "There continues to be a significant unmet medical need whereTYSABRI will be an important treatment option. "
Today's action follows a March 8, 2006 unanimous recommendation bythe FDA's Peripheral and Central Nervous System Drugs AdvisoryCommittee to allow the reintroduction of TYSABRI. Biogen Idec and Elanvoluntarily suspended TYSABRI from the U.S. market and all ongoingclinical trials in February 2005 based on reports of PML, anopportunistic viral infection of the brain that usually leads to deathor severe disability.
TOUCH Prescribing Program
TOUCH (TYSABRI Outreach: Unified Commitment to Health) PrescribingProgram was developed in conjunction with the FDA to facilitate theappropriate use of TYSABRI and to assess, on an ongoing basis, theincidence and risk factors for PML and other serious opportunisticinfections associated with TYSABRI treatment. This program representsBiogen Idec and Elan's commitment to making the unique benefits ofTYSABRI available in a responsible manner.
Elements of the TOUCH Prescribing Program include:
-- Revised labeling with a prominent boxed warning of the risk of PML; and warnings against concurrent use of TYSABRI with chronic immunosuppressant or immunomodulatory therapies, and patients who are immunocompromised due to HIV, hematological malignancies, organ transplants or immunosuppressive therapies
-- Mandatory enrollment for all prescribers, central pharmacies, infusion centers and patients who wish to prescribe, distribute, infuse, or receive, respectively, TYSABRI
-- Controlled, centralized distribution only to authorized infusion centers
-- Mandatory FDA-reviewed educational tools for patients and physicians, including a patient medication guide, TOUCH enrollment form and a monthly pre-infusion checklist
-- Ongoing assessment of PML risk and overall safety
-- A 5,000 patient cohort observational study over five years, the TYSABRI Global Observation Program in Safety (TYGRIS)
About TYSABRI
Two-year data from the AFFIRM monotherapy trial showed thattreatment with TYSABRI reduced the risk of disability progression by42% (p is less than 0.001), the primary endpoint of the study, and ledto a 67% reduction (p is less than 0.001) in the annualized relapserate compared to placebo. TYSABRI treatment also resulted in sustainedand statistically significant reductions in brain lesion activity asmeasured by MRI. The two-year data from the SENTINEL add-on trial alsodemonstrated that treatment with TYSABRI in addition to AVONEX(R)(Interferon beta-1a) had a significant effect on disabilityprogression, relapse rate and brain MRI disease activity compared toAVONEX alone.
TYSABRI increases the risk of PML, an opportunistic viralinfection of the brain that usually leads to death or severedisability. Three cases of PML occurred in clinical trial patients whowere concomitantly exposed to immunomodulators (interferon beta in thepatients with MS) or were immunocompromised due to recent treatmentwith immunosuppressants (e.g., azathioprine in the patient withCrohn's disease). Two of the cases were observed in 1,869 patientswith MS treated for a median of 120 weeks. A third case of PMLoccurred among 1,043 patients with Crohn's disease after the patientreceived eight doses. The number of cases is too few and the number ofpatients treated too small to reliably conclude that the risk of PMLis lower in patients treated with TYSABRI alone than in patients whoare receiving other drugs that decrease immune function or who areotherwise immunocompromised. Healthcare professionals should monitorpatients on TYSABRI for any new signs or symptoms that may besuggestive of PML. TYSABRI dosing should be withheld immediately atthe first sign or symptom suggestive of PML.
TYSABRI is contraindicated in patients who have or have had PML orwith known hypersensitivity to TYSABRI or any of its components. InPhase III placebo-controlled trials of TYSABRI in MS, the overallincidence and rate of other infections were balanced betweenTYSABRI-treated patients and controls. Herpes infections were slightlymore common in patients treated with TYSABRI. Commonly reportedinfections with TYSABRI included urinary tract infections, lowerrespiratory tract infections, gastroenteritis and vaginitis. Seriousopportunistic and other atypical infections have been observed inTYSABRI-treated patients, some of these patients were receivingconcurrent immunosuppressants.
The incidence and rate of other serious and common adverse eventsin clinical trials were similarly balanced between treatment groups.Serious events that occurred in TYSABRI-treated patients includedhypersensitivity reactions (e.g., anaphylaxis), depression andgallstones. Appendicitis was more common in patients receiving TYSABRIwith AVONEX. Common adverse events reported in TYSABRI-treatedpatients include infusion reactions, headache, fatigue, joint and limbpain, abdominal discomfort, diarrhea and rash.
For more information about TYSABRI please visit www.biogenidec.comor www.elan.com.
Webcast
The companies will host a joint webcast for the investmentcommunity tomorrow at 8:30 am ET, 1:30 pm GMT, which can be accessedthrough the companies' websites.
About Biogen Idec
Biogen Idec creates new standards of care in oncology, neurologyand immunology. As a global leader in the development, manufacturing,and commercialization of novel therapies, Biogen Idec transformsscientific discoveries into advances in human healthcare. For productlabeling, press releases and additional information about the company,please visit www.biogenidec.com.
About Elan
Elan Corporation, plc is a neuroscience-based biotechnologycompany committed to making a difference in the lives of patients andtheir families by dedicating itself to bringing innovations in scienceto fill significant unmet medical needs that continue to exist aroundthe world.
Elan shares trade on the New York, London and Dublin StockExchanges. For additional information about the company, please visitwww.elan.com. | | |
| "We are pleased with the FDA's decision to once again make Natalizumab available to patients and their families suffering from this chronic, debilitating disease, " said Kelly Martin, Chief Executive Officer, Elan. "There continues to be a significant unmet medical need where Natalizumab will be an important treatment option. "
Today's action follows a March 8, 2006 unanimous recommendation by the FDA's Peripheral and Central Nervous System Drugs Advisory Committee to allow the reintroduction of Natalizumab. TOUCH (TYSABRI?[Natalizumab] Outreach: Unified Commitment to Health) Prescribing Program was developed in conjunction with the FDA to facilitate the appropriate use of Natalizumab and to assess, on an ongoing basis, the incidence and risk factors for PML and other serious opportunistic infections associated with Natalizumab treatment. This program represents Biogen Idec and Elan's commitment to making the unique benefits of Natalizumab available in a responsible manner. Elements of the TOUCH Prescribing Program include revised labeling with a prominent boxed warning of the risk of PML; and warnings against concurrent use of Natalizumab with chronic immunosuppressant or immunomodulatory therapies, and patients who are immunocompromised due to HIV, hematological malignancies, organ transplants or immunosuppressive therapies, mandatory enrolment for all prescribers, central pharmacies, infusion centres and patients who wish to prescribe, distribute, infuse, or receive, respectively, Natalizumab; controlled, centralized distribution only to authorized infusion centers, mandatory FDA-reviewed educational tools for patients and physicians, including a patient medication guide, TOUCH enrollment form and a monthly pre-infusion checklist, ongoing assessment of PML risk and overall safety, a 5,000 patient cohort observational study over five years, the Natalizumab Global Observation Program in Safety (TYGRIS)
Natalizumab treatment also resulted in sustained and statistically significant reductions in brain lesion activity as measured by MRI. The two-year data from the SENTINEL add-on trial also demonstrated that treatment with Natalizumab in addition to AVONEX?(Interferon beta-1a) had a significant effect on disability progression, relapse rate and brain MRI disease activity compared to AVONEX alone.
Natalizumab increases the risk of PML, an opportunistic viral infection of the brain that usually leads to death or severe disability. Three cases of PML occurred in clinical trial patients who were concomitantly exposed to immunomodulators (interferon beta in the patients with MS) or were immunocompromised due to recent treatment with immunosuppressants (e.g., azathioprine in the patient with Crohn's disease). A third case of PML occurred among 1,043 patients with Crohn's disease after the patient received eight doses. The number of cases is too few and the number of patients treated too small to reliably conclude that the risk of PML is lower in patients treated with Natalizumab alone than in patients who are receiving other drugs that decrease immune function or who are otherwise immunocompromised. Healthcare professionals should monitor patients on Natalizumab for any new signs or symptoms that may be suggestive of PML. Natalizumab dosing should be withheld immediately at the first sign or symptom suggestive of PML.
Natalizumab is contraindicated in patients who have or have had PML or with known hypersensitivity to Natalizumab or any of its components. In Phase III placebo-controlled trials of Natalizumab in MS, the overall incidence and rate of other infections were balanced between Natalizumab-treated patients and controls. Herpes infections were slightly more common in patients treated with Natalizumab. Commonly reported infections with Natalizumab included urinary tract infections, lower respiratory tract infections, gastroenteritis and vaginitis. Serious opportunistic and other atypical infections have been observed in Natalizumab-treated patients, some of these patients were receiving concurrent immunosuppressants.
Serious events that occurred in Natalizumab-treated patients included hypersensitivity reactions (e.g., anaphylaxis), depression and gallstones. Appendicitis was more common in patients receiving Natalizumab with AVONEX. Common adverse events reported in Natalizumab-treated patients include infusion reactions, headache, fatigue, joint and limb pain, abdominal discomfort, diarrhoea and rash.
For any corrections of factual information, to contact the editors or to send any medical news or health news press releases, use feedback form | | |
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