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Some of the most common sounds of summer can expose listeners to permanent hearing loss, one researcher warns.
The cautionary note was sounded by David Coffin, director of Ball State University’s audiology clinic in Indiana.
Risky noise, he says, can come in the form of the pop of fireworks, the snarls of traffic, the buzz of lawn mowers, or the percussive tones of marching bands.
Such sounds are typically within the range of 90 decibels to 140 decibels, said Coffin, but any noise above 80 decibels can cause long-term hearing damage.
“We are living in a society that gets louder every year,” Coffin said in a news release from Ball State. “Now that the weather is warmer, we are exposed to all sorts of sounds that can lead to permanent hearing loss. The average person will wear a helmet when riding a bike, or a seat belt in a vehicle, but doesn’t even think about ear protection when going to watch a rock band, a fireworks display, or even an auto race.”
According to the National Center for Health Statistics, almost 15 percent of Americans below the age of 19 suffer from some measure of hearing loss.
Signs of hearing loss due to unsafe sound exposure include not being able to comprehend somebody talking from two feet away; hearing muffled speech; experiencing pain or ringing in the ears following exposure; and needing others to speak louder in conversation.
However, Coffin stressed that while hearing loss is not reversible, noise exposure is a serious but preventable problem.
To reduce risk, Coffin advises that people wear ear plugs or alternative forms of hearing protection to buffer the noise pollution of summer.
SOURCE: Ball State University.
Moderate drinking may help protect against the onset of Alzheimer’s disease among otherwise healthy people, a new Spanish study suggests.
Women who don’t smoke appear to gain the most benefit from alcohol consumption, according to the research team, from the University of Valencia, the Valencia government and the Municipal Institute of Medical Investigation in Barcelona.
“Our results suggest a protective effect of alcohol consumption, mostly in non-smokers, and the need to consider interactions between tobacco and alcohol consumption, as well as interactions with gender, when assessing the effects of smoking and/or drinking on the risk of Alzheimer’s disease,” the study’s lead author, Ana M. Garcia, from the University of Valencia’s department of preventive medicine and public health, said in a news release.
“Interactive effects of smoking and drinking are supported by the fact that both alcohol and tobacco affect brain neuronal receptors,” Garcia explained.
The findings, published in the May issue of the Journal of Alzheimer’s Disease, are gleaned from a comparative analysis of both the medical background and the smoking and drinking habits among people with Alzheimer’s disease stacked up against a group of healthy individuals.
Both groups were similar in age and in gender breakdown.
Smoking appeared to have no impact on Alzheimer’s risk, the authors found. However, moderate drinking did seem to reduce risk for the disease, particularly among non-smoking women.
SOURCE: Journal of Alzheimer’s Disease, news release.
Researchers have identified a distinct pattern of gene expression in the largest reported group of kidney transplant recipients who have not rejected the transplant kidneys even though they stopped taking anti-rejection drugs. This finding may help identify other transplant recipients who could safely reduce or end use of immunosuppressive therapy. In 2008, more than 80,000 people in the United States were living with a kidney transplant.
The findings come from the Immune Tolerance Network (ITN), an international research consortium supported by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Diabetes and Digestive and Kidney Diseases, of the National Institutes of Health, and the Juvenile Diabetes Research Foundation International. The research team included three lead investigators, Kenneth Newell, M.D., Ph.D., of Emory University in Atlanta; Laurence Turka, M.D., of Beth Israel Deaconess Medical Center and Harvard Medical School in Boston; and Vicki Seyfert-Margolis, Ph.D., the former Chief Scientific Officer of ITN and currently at the Food and Drug Administration. Their report appears online in the Journal of Clinical Investigation.
“The immunosuppressive therapy regimens that organ transplant recipients must endure have toxic side effects and increase the recipients’ vulnerability to infections and cancer,” says NIAID Director Anthony S. Fauci, M.D. “This study holds promise for identifying kidney transplant recipients who might be able to minimize or withdraw from their use of anti-rejection drugs. However, large, prospective studies will be necessary to determine if the same biomarkers identified in the current study are reliable predictors of immune tolerance.”
Following a kidney transplant, recipients must be placed on immunosuppressive therapy or their immune systems will reject the transplanted organ. However, these drugs suppress the entire immune system, reducing an individual’s ability to fight infections, and sometimes leading to diseases related to a weakened immune system, such as cancer. The drugs also have other severe side effects such as diabetes, hypertension and heart disease, as well as swelling, weight gain, and excessive hair growth and acne that many people find intolerable.
In rare cases, a physician may stop a transplant recipient’s immunosuppressive drugs because of a serious medical problem such as cancer or life-threatening infection. In other cases, transplant recipients decide to reduce or stop immunosuppressive therapy against their physicians’ advice, even though by doing so, they risk losing their transplanted organ. However, in a very small percentage of such cases, rejection does not occur after the drugs are stopped.
This study included 25 kidney transplant recipients who had ceased taking their immunosuppressive drugs of their own accord and yet had retained normal kidney function for more than one year. The researchers compared this group with two other groups: recipients who were still taking their immunosuppressive medication and had healthy kidneys, and healthy, non-transplant controls.
The team examined blood samples taken from participants in each of the three groups. They analyzed the gene expression of the cells in whole blood and observed that the transplant recipients who were not taking medication had a distinct pattern of genes expressed by B cells, a type of white blood cell. This pattern differed from those seen in participants who were still on immunosuppressive therapy and in non-transplant healthy control subjects. Further study identified a pattern of expression of three B cell genes that was far more common in patients who had stopped taking their medications yet maintained good graft function.
White blood cells include T and B cells. Recent studies of immune tolerance have focused on the role of a subset of T cells, called regulatory T cells (Tregs). Work in animal models indicates that B cells also may help promote immune tolerance.
“We expected to find a difference between the tolerant and immunosuppression groups in the genes associated with Tregs,” says Dr. Newell. “However, we were surprised that our data showed that B cell genes may play an important role in maintaining and possibly inducing tolerance to transplanted organs.”
According to Dr. Turka, identifying potential biomarkers of immune tolerance is the first step in identifying transplant recipients whose immunosuppression therapy could be reduced. “If we could develop a reliable tolerance signature — a pattern of gene expression that indicates that someone will not reject a transplant — then we could find patients who would make good candidates for supervised drug withdrawal,” he said.
The study team stresses that transplant patients should never consider reducing or changing their medication regimen unless under the direct supervision of their physician. According to Drs. Newell and Turka, doing so would “almost certainly result in the rejection of the kidney, leaving the patient in need of another transplant.”
Follow-up studies of this gene pattern are being planned. Similar findings already have been provided by a European group, led by King’s College in London, that conducted a comparable study in kidney transplant patients. Their results appear in the same issue of the Journal of Clinical Investigation.
“The goal of ITN is to understand how immune tolerance can be induced or achieved in a variety of settings, including allergy, autoimmune disease and transplantation,” says Daniel Rotrosen, M.D., director of the Division of Allergy, Immunology and Transplantation at NIAID. “Potentially, a biomarker for tolerance in kidney transplant recipients may predict tolerance in individuals following transplantation of other organs or with other immune-mediated diseases. Having a cooperative program like ITN allows investigators to explore this possibility and apply the findings of one study across different fields of clinical research.”
NIDDK, part of NIH, conducts and supports basic and clinical research and research training on some of the most common, severe and disabling conditions affecting Americans. The Institute’s research interests include: diabetes and other endocrine and metabolic diseases; digestive diseases, nutrition, and obesity; and kidney, urologic and hematologic diseases. For more information, visit www.niddk.nih.gov.
NIAID conducts and supports research — at NIH, throughout the United States, and worldwide — to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at www.niaid.nih.gov.
The U.S. Food and Drug Administration approved Lumizyme (alglucosidase alfa) for patients ages 8 years and older with late-onset (non-infantile) Pompe disease, a rare genetic disorder.
Pompe disease occurs in an estimated 1 in every 40,000 to 300,000 births. Its primary symptom is heart and skeletal muscle weakness, progressing to respiratory weakness and death from respiratory failure.
In Pompe disease, a gene mutation prevents the body from making an enzyme, or making enough of the enzyme called acid alpha-glucosidase (GAA), necessary for proper muscle functioning. GAA is used by the heart and muscle cells to convert a form of sugar called glycogen into energy. Without the enzyme action, glycogen builds up in the cells and, ultimately, weakens the heart and muscles.
Lumizyme is believed to work by replacing the deficient GAA, thereby reducing the accumulated glycogen in heart and skeletal muscle cells.
“Pompe disease is a devastating condition without the appropriate treatment,” said Julie Beitz, M.D., director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research. “The approval of Lumizyme will provide an important treatment for patients diagnosed later in life with Pompe disease.”
Lumizyme is being approved with a risk evaluation and mitigation strategy (REMS). It will only be available through a restricted distribution system called the Lumizyme ACE (Alglucosidase Alfa Control and Education) Program to ensure that it is used by the correct patient group.
Lumizyme will carry a Boxed Warning because of the risk of anaphylaxis, severe allergic reactions, and immune-mediated reactions.
Currently, the only other treatment for Pompe disease available in the United States is Myozyme, which is also manufactured by Genzyme at its manufacturing facilities in Framingham and Allston Landing, Mass. Myozyme has been in short supply due to limited manufacturing capacity. The manufacturer reserved Myozyme to treat infants and children with Pompe disease because younger patients generally have a much more aggressive form of the disease.
Some adult patients in the U.S. received Lumizyme under a temporary access program. The approval of Lumizyme will ensure that treatment is available for all U.S. adult Pompe patients in need of treatment. Lumizyme is manufactured at Genzyme facilities in Ireland and Belgium.
Lumizyme’s safety and effectiveness have not been evaluated in patients with infantile-onset Pompe disease or in patients ages 8 years and younger with late-onset disease. These patients should be treated with Myozyme, not Lumizyme.
The safety and efficacy of Lumizyme are based on a clinical study in 90 patients, ages 10 years to 70 years, with late-onset Pompe disease. The most commonly reported side effects for Lumizyme were infusion-related reactions and included severe allergic reactions, hives, diarrhea, vomiting, shortness of breath, itchy skin, skin rash, neck pain, partial hearing loss, flushing, pain in extremities, and chest discomfort.
Myozyme and Lumizyme are marketed by Cambridge, Mass.-based Genzyme.
Among cancer patients on Medicare, the costs for medical scans have increased twice as fast as overall costs for cancer care, Duke University researchers report.
“There has been a significant increase in the utilization of imaging services for cancer patients since 1999, especially advanced imaging services such as CAT scans, MRI and PET scans — the most expensive studies,” said lead researcher Dr. Kevin A. Schulman, a professor of medicine and business administration and associate director of the Duke Clinical Research Institute.
Schulman noted that more scans do not necessarily result in better treatment or outcomes. Patients, he added, can play a role in limiting the number of unnecessary scans.
“It’s OK to ask your physicians why they are ordering an imaging test and how you might benefit from the result,” he said.
The Duke report is published in the April 28 issue of the Journal of the American Medical Association.
For the study, Schulman’s group collected data on imaging costs of 100,954 cancer patients on Medicare who were diagnosed with breast, lung, prostate or colon cancer, leukemia or lymphoma between 1999 and 2006.
The researchers found that while overall costs for treating these patients rose 2 percent to 5 percent a year, the cost for imaging scans increased between 5 percent and 10 percent.
Although the costs for imaging increased faster than costs for overall care, imaging costs make up only about 6 percent of Medicare costs for each patient, the researchers noted.
The most growth was seen in the number of PET scans. The average annual number of PET scans grew from 36 percent to 53 percent, but they still remain the least-used scanning technology. However, these scans are the most expensive, running as much as six times higher than CT scans.
When PET scans were first introduced, Medicare did not pay for them, but by 2005 about 50 percent of patients with lung cancer and lymphoma were getting one or more PET scans, Schulman noted.
In 1999, patients diagnosed with lung cancer had about 21 imaging scans during the first two years of treatment. By 2006, that had increased to 24.
The highest imaging costs were for patients with lung cancer and lymphoma, averaging $3,000 during the first two years of treatment, the researchers found.
In addition, bone density studies increased in popularity. In fact, the number of breast cancer patients getting bone density studies almost doubled by 2005, with about one-third of all patients receiving one or more scans.
Michael T. French, a professor of economics, epidemiology and public health at the University of Miami, isn’t surprised that these costs have gone up so dramatically.
“Imaging has advanced considerably in recent years,” he said. “So, it’s logical that it would be used more often, and along with the higher costs of increased use are the costs of improved technology.”
French thinks that some of the increased use of imaging is related to increased reimbursement and competitiveness among hospitals. “Is there excessive use of imaging to improve profits? Yes,” French said.
In addition, there is a defensive aspect to the increased use of imaging, French said. “If the technology is present and physicians don’t use it, then if something happens to the patient there is a possibility for a lawsuit,” he said.
The bottom-line question is how imaging is being used, French said. “It’s a question of whether it’s wasteful or whether it’s higher cost to produce better outcomes,” French said. “Right now, we don’t know what all this leads to in terms of better outcomes.”
A group representing the medical imaging industry believe they have an answer to that question, however.
The Access to Medical Imaging Coalition point to a recent study, conducted by Columbia University professor of business Frank Lichtenberg and based on data from the National Cancer Institute and Thomson Medstat. That study found that, “cancer imaging innovation accounted for 40 percent of the reduction in U.S. cancer deaths between 1996 and 2006, making it likely the largest single contributor to decreased cancer mortality during this time period,” according to a news release from the coalition.
“Given that previous researchers have equated a one percent reduction in cancer mortality to nearly $500 billion in health care savings per year,” the findings suggests a role for medical imaging in cutting health care costs, the group said.
SOURCES: Kevin A. Schulman, M.D., M.B.A., professor, medicine and business administration, and associate director, Duke Clinical Research Institute, Duke University, Durham, N.C.; Michael T. French, Ph.D., professor, economics, epidemiology and public health, University of Miami;
Cervical cancer screening intervals could be extended for women aged 30 and over if doctors used human papillomavirus (HPV) testing rather than smear tests, British scientists said on Wednesday.
Experts said research into different screening methods found that HPV tests were very accurate in picking up early signs of cervical cancer and detected more serious abnormalities than conventional smear tests in women aged 30 and over.
“Using HPV testing as the primary screening method for cervical cancer would not only mean women could be screened less often but it would also mean efficiency savings,” said Jack Cuzick, a professor of epidemiology at Queen Mary, University of London, who worked on the study.
Several companies, including Roche, Gen Probe Inc, Abbott and Qiagen make HPV tests.
HPV is the most common sexually transmitted infection in the world. There are more than 100 types of the virus, some of which cause only genital warts but others cervical cancer.
According to the World Health Organisation, cervical cancer is the second biggest cause of female cancer deaths worldwide with about 288,000 deaths each year.
Cervical screening programs are well established in many wealthy nations and immunization programs against HPV with vaccines such as Cervarix from GlaxoSmithKline and Gardasil from Merck & Co are also being rolled out.
Cuzick’s study, which was published in the British Journal of Cancer, involved 11,000 women in the UK. Two samples were taken from each woman and one analyzed using the conventional cytology method, while the other was sent for HPV testing.
ACCURACY
Cytology involves an analysis of cervical cells taken during a smear test.
The results showed that women with HPV negative results had a lower rate of developing pre-cancerous cells for at least six years compared with women who recorded a negative cytology result, showing that HPV testing was more accurate.
A second study conducted by Finnish scientists, published in the British Medical Journal, showed that HPV testing is also better than cytology at detecting severe pre-cancerous lesions.
In a telephone interview, Cuzick said the evidence now showed clearly that regular testing programs in all countries that conduct them should be swap to using HPV tests.
“There is now an overwhelming case for moving to HPV as the primary screening test,” he said. “If you have a test that gets it right the first time, you can also increase the gap between screens, saving doctors’ time.”
Current policy in Britain is to test using cytology every three years from age 30 to 50 and then every 5 years for older women. In the United States, smear tests are recommended every two years from age 21 to 30 and every three years beyond that.
Cervical cancer is a slow-growing cancer, which means that more accurate HPV screening would only need to be done about every five years to be effective, Cuzick said.
(Editing by Andrew Roche)
High-dose vitamin B therapy is dangerous for diabetics with kidney disease, and patients on this regimen should stop immediately, says a new study.
When the researchers began the study, they believed it would show that high-dose vitamin B therapy (folic acid, vitamin B6 and vitamin B12) would improve patients’ kidney function and reduce their risk of heart attack and stroke.
But it turned out that patients on high-dose vitamin B therapy had significant worsening of kidney function, and twice as many heart and stroke incidents as patients taking a placebo.
“Because B vitamins are water soluble, we suspect that while healthy people would excrete excess vitamins in urine, those with renal failure would not be able to do so, perhaps causing the adverse effects we have seen in this study,” Dr. David Spence, of the University of Western Ontario in Canada, said in a university news release.
“Vitamin B therapy may still be beneficial in people with normal kidney function, but this is clear evidence that high doses of vitamin B should not be given to those with kidney problems,” he added.
The study is published in the issue of the Journal of the American Medical Association.
More than 40 percent of people with diabetes develop kidney disease.
One common follicular problem that affects a disproportionate number of dark-skinned patients, particularly African-Americans, is pseudofolliculitis barbae (also known as razor bumps). Dr. Alexis noted that several studies have reported that pseudofolliculitis barbae affects an estimated 45 to 83 percent of African-American men. The cause of this condition stems from the structure of the hair follicle, which is curved in people with skin of color. Pseudofolliculitis barbae is aggravated by shaving, as it can cause the sharp tip of shaved hair to grow back into the skin and results in a bump.
Dr. Alexis advises patients affected by pseudofolliculitis barbae to discuss ways to modify their shaving habits with their dermatologist. He also noted that there are several effective treatment options available.
For example, lasers have evolved over the years and can now be safely used to reduce and remove hair in skin of color patients. Two lasers Dr. Alexis recommends for use with darker skin are the 810 nanometer (nm) diode laser and the 1064nm Nd:YAG laser. Topical creams and gels also are effective in treating pseudofolliculitis barbae, including topical retinoids, topical antibiotics, topical steroids and the topical prescription medication eflornithine.
“Women of color also can be affected by pseudofolliculitis barbae, as they often wax or shave unwanted hair on their chin and neck that can cause these bumps and skin discoloration,” said Dr. Alexis. “Many of these women are finding laser hair removal to be an effective treatment option for this problem.”
Hair loss is another dermatologic concern in patients with skin of color. Traction alopecia is a form of hair loss caused by hairstyles (such as braids) that put tension on the hair and is most common in African-American women. “The majority of cases of traction alopecia are reversible, but patients must be willing to style their hair differently to stop and reverse hair loss,” said Dr. Alexis. “Dermatologists also can administer injections of steroids into the affected areas, which we find can be quite effective if started early in the course of the condition.”
Another form of hair loss common in dark-skin individuals that can be more difficult to treat is central centrifugal cicatricial alopecia (CCCA). Although the cause of CCCA is unknown, it also is thought to be related to common hair care practices in African-American women. Often referred to as “hot comb alopecia”, this type of hair loss begins on the crown of the scalp and gradually spreads out to other areas of the scalp.
Dr. Alexis noted that once a hair follicle is scarred, it cannot produce hair any longer, but if caught early, hair loss can be treated with a variety of anti-inflammatory therapies, including injections into the affected areas of the scalp, topical steroids and oral antibiotics. Dr. Alexis added that minoxidil can be used in conjunction with anti-inflammatories to try to stimulate hair growth in healthy hair follicles.
Reversing Cosmetic Dermatologic Concerns Can Be Done Safely
Dr. Alexis explained that the water content of the skin decreases with age, especially when people enter their 60s. For people of color, this change in the water content of their skin can create an ashen look if they do not use moisturizers to help counteract the water loss. Other changes in the skin include textural irregularities, such as roughness, enlarged pores and dullness.
To help reverse some of these telltale signs of aging in darker-skinned individuals, a variety of topicals and non-invasive procedures can be used safely and effectively – including retinoids and other cosmeceuticals, chemical peels, and non-ablative laser resurfacing. Fillers can be used to correct nasolabial folds (lines around the mouth) and botulinum toxin is effective in softening wrinkles.
“It is important to note that injections of both fillers and botulinum toxin can be performed safely in darker-skinned patients, and these procedures are increasing in popularity with these patients to address aging skin,” said Dr. Alexis.
Another skin condition that is common in African-American patients as they age is dermatoses papulosa nigra (DPNs), also referred to as flesh moles. These small, brown moles are especially common in the cheek area and can be removed by a dermatologist who carefully will remove these skin growths to minimize any injury to the skin.
“While people of color are prone to many unique medical and cosmetic skin conditions, dermatologists are well equipped to treat them using a variety of safe and effective treatment options,” said Dr. Alexis. “The key is to seek treatment early.”
Headquartered in Schaumburg, Ill., the American Academy of Dermatology (Academy), founded in 1938, is the largest, most influential, and most representative of all dermatologic associations. With a membership of more than 16,000 physicians worldwide, the Academy is committed to: advancing the diagnosis and medical, surgical and cosmetic treatment of the skin, hair and nails; advocating high standards in clinical practice, education, and research in dermatology; and supporting and enhancing patient care for a lifetime of healthier skin, hair and nails. For more information, contact the Academy at 1-888-462-DERM (3376) or www.aad.org.
According to projections from the United States Census Bureau, people with skin of color will comprise approximately half of the U.S. population by 2050. This group, which includes African-Americans, Asians, Latinos and other ethnicities, are more prone to certain dermatologic problems than those with lighter skin tones due to their genetic make-up and in some cases cultural practices. For that reason, dermatologists – who understand the nuances of different skin tones – are poised to help patients of color by diagnosing and treating these conditions.
Speaking today at the 68th Annual Meeting of the American Academy of Dermatology (Academy), dermatologist Andrew F. Alexis, MD, MPH, FAAD, assistant clinical professor of dermatology at Columbia University College of Physicians and Surgeons and staff member at St. Luke’s-Roosevelt Hospital Center, both in New York, discussed the leading medical and cosmetic dermatologic concerns in darker-skinned populations.
“Although people of color have more natural protection from ultraviolet (UV) radiation due to the increased amount of melanin in their skin, the cells that make melanin pigment tend to be more reactive to inflammation and injury, and therefore pigmentation problems are more common in skin of color,” said Dr. Alexis. “These natural genetic factors, coupled with cultural differences in their skin and hair care practices, can result in differences in the appearance of common dermatologic conditions and the frequency in which they can occur.”
Treating Pigmentation Disorders Takes Patience
The most common pigmentation problem (dyschromia) of the skin that can occur in people of color is post-inflammatory hyperpigmentation (PIH), which refers to increased pigmentation or dark spots at the sites of inflammation. Acne is one trigger for PIH, and the resulting dark spots often can be of equal or greater concern than the original pimples.
Dr. Alexis explained that although there are several effective treatments that can be used for PIH, none of these treatments are quick fixes and each requires time to take effect – from several weeks to several months in most cases. Common treatments include retinoid creams (vitamin A derivatives), bleaching creams (containing hydroquinone) and chemical peels.
“While in-office procedures, such as chemical peels or any skin resurfacing cosmetic treatment, can help correct pigmentation problems, they have to be administered with caution due to the higher risk of inducing other pigmentary abnormalities,” stated Dr. Alexis. “That’s why it is important to consult a dermatologist with an expertise not only in using these procedures, but in treating darker skin tones as well.”
Melasma, often referred to as the “mask of pregnancy,” is the second most common pigmentation problem occurring in skin of color patients. More women than men are affected by melasma, but the condition can occur independent of pregnancy and is commonly seen in people in their 40s, 50s and 60s. The cause of melasma is a combination of genetic and hormonal factors and UV exposure. Dr. Alexis added that melasma can be treated with the same topicals and in-office procedures used for PIH, and in some cases, lasers can be effective.
Since sun exposure can worsen dark spots, Dr. Alexis stressed that year-round sun protection is extremely important. “I recommend that my patients wear a moisturizer with sunscreen every day to protect their skin from further damage,” said Dr. Alexis.