Generic Viagra (Sildenafil) Pills

The Food and Drug Administration and the National Institutes of Health today launched a new Web site that, when fully developed, will provide a mechanism for the reporting of pre- and post-market safety data to the federal government. Currently the Web site can be used to report safety problems related to foods, including animal feed, and animal drugs, as well as adverse events occurring on human gene transfer trials. Consumers can also use the site to report problems with pet foods and pet treats.

The new site, called the Safety Reporting Portal (SRP), provides greater and easier access to online reporting.

“The portal will be a key detection tool in improving the country’s nationwide surveillance system and will strengthen our ability to protect the nation’s health,” said Commissioner of Food and Drugs Margaret A. Hamburg. “We will now be able to analyze human and animal safety-related events more quickly and identify those measures needed to protect the public.”

The new Web portal includes different features for different types of reporting:
Reportable Food Registry: Industry will have a more user-friendly electronic portal for submitting reportable food reports that are required by law. This electronic portal collects reports from the food industry and public health officials regarding problems with articles of food, including animal feed, that present a reasonable probability of causing serious adverse health consequences or death to humans or animals.
Pets: Pet owners and veterinarians will be able to use the portal to report product problems with pet foods and pet treats.
Animal drugs: Animal drug manufacturers can report adverse drug events associated with animal drugs.
Clinical Trials: Biomedical researchers involved in human gene transfer clinical trials can report an adverse event, indicating whether it might be an unanticipated consequence of the product being tested. Trial sponsors can use the portal to prepare a report, print it and send it to the agency to satisfy reporting requirements for investigational new drugs.

In the future, the system will encompass other types of clinical trials and, eventually, safety problems arising from products regulated by a broad array of federal agencies. This is a first step toward a common electronic reporting system that will offer one-stop shopping, allowing an individual to file a single report to multiple agencies that may have an interest in the event.

Just as important, the portal will ultimately enhance the government’s systematic analysis of safety information, which will benefit public health. In the meantime, the new portal redirects individuals who want to submit reports about other products regulated by FDA, the U.S. Department of Agriculture, Environmental Protection Agency or the Consumer Product Safety Commission to the appropriate contact.

Men in a relationship with an HIV-positive woman face double the risk of becoming infected themselves when their partner is pregnant, new research reveals.

The finding is slated for presentation Sunday at the International Microbicides Conference in Pittsburgh.

The two-year study — launched in Botswana, Kenya, Rwanda, South Africa, Tanzania, Uganda and Zambia — focused on more than 3,300 couples in which one of the partners was HIV-positive.

Dr. Nelly Mugo, from the University of Nairobi and Kenyatta National Hospital in Nairobi, and colleagues teamed with investigators from the University of Washington in Seattle to track 1,085 couples in which the man was HIV-positive, and 2,236 couples in which the woman was infected.

During the duration of the study, 823 pregnancies occurred. The study authors found that pregnancy increased HIV transmission in both directions: male-to-female and female-to-male.

However, the observed infection risk for women appeared to be a function of several factors beyond pregnancy itself, including sexual behavior. For men, the link between pregnancy and risk increase was much stronger and more direct, Mugo’s team noted.

Factors such as the viral load and CD4 count (an indicator of immune system strength) of the infected female partner had no impact on the man’s risk. Nor did the man’s circumcision status or whether or not the couple had engaged in unprotected sex, the researchers found.

The research team therefore theorized that the doubling of female-to-male transmission risk during pregnancy might be attributed to both immunological and physiological changes — as yet unidentified — that are triggered by pregnancy. But they cautioned that more research will be needed to explore this possible explanation.

SOURCE: International Microbicides Conference, news release.

Tablets, insertable rings and dissolving films can effectively deliver drugs to help protect women and perhaps men from infection with the AIDS virus, researchers reported on Monday.

They also found evidence that using such an approach — called a microbicide — may help overcome some of the risks of drug resistance that can come with taking pills to prevent infection.

Here are some of the findings from the International Microbicides Conference being held in Pittsburgh:

* A flexible ring designed for use in the vagina can continually deliver two AIDS drugs for up to a month. Andrew Loxley of Bethlehem, Pennsylvania-based Particle Sciences, Inc., and colleagues lab tested a vaginal ring that time-released dapivirine, a drug made by Johnson & Johnson’s Tibotec Inc and licensed to the International Partnership for Microbicides, and the entry inhibitor maraviroc sold by Pfizer under the brand name Selzentry. It has not been tested in people yet.

* A vaginal tablet worked in similar fashion, time-releasing maraviroc and another experimental HIV drug called DS003, licensed to the International Partnership for Microbicides by Bristol-Myers Squibb, Sanjay Garg of the University of Auckland in New Zealand told the conference. The tablet uses a polymer designed to attach to the moist lining inside the vagina.

* A third approach uses a film, Anthony Ham of ImQuest BioSciences of Frederick, Maryland reported. ImQuest is testing the HIV drug IQP-0528 in a film smaller and thinner than a stick of gum, similar to a mouthwash strip.

* Susan Schader of McGill University in Montreal, Canada, and colleagues said tests of these and other HIV drugs used as microbicides showed that drug resistance emerged only if HIV was in the lab dish first — which suggests people would only develop drug-resistant infections by using microbicides when they were already infected.

* The AIDS virus infects more than 33 million people globally and it has killed 25 million, according to the United Nations AIDS agency UNAIDS. Globally, more than half of those with HIV are women, most infected by husbands or steady partners and many of whom who are unable to insist on use of a condom.

* AIDS experts have long been searching for a microbicide — a cream, gel or vaginal ring that women or men could use as a chemical shield to protect themselves from sexual transmission of the deadly and incurable virus.

* Microbicides using HIV drugs would represent a large new market for the companies that make the drugs, which are now used only to treat infection.

(Reporting by Maggie Fox; Editing by Xavier Briand)

Fat injections can help restore normal speech and improve quality of life in patients with paralyzed vocal cords, new research shows.

So-called unilateral vocal cord (or fold) paralysis occurs when nerves serving one side of the “voice box” are damaged, paralyzing one of the vocal cords. Patients have weak, breathy voices and may also inhale liquid into the lungs or choke while drinking.

Surgery involving the neck area, such as removal of the thyroid, is the most frequent cause of nerve damage, although it can also occur in the elderly who have not had neck surgery. It’s unclear how many people develop it, but one study found a rate of about one in 240 per year.

Although some cases of vocal cord paralysis do not require treatment, and others can be fixed using voice therapy, surgery is often needed. Such surgery involves bringing the inactive vocal cord closer to the healthy one, to improve speech and make swallowing easier. Surgeons have used a wide variety of materials in these surgeries, from collagen to Teflon, although the latter has been largely abandoned because of troubling growths that resulted.

In the current study, Dr. Tuan-Jen Fang of Chang Gung University in Taoyuan and colleagues report on a series of unilateral vocal cord paralysis patients who underwent fat injections at Chang Gung Memorial Hospital. Fang and his team used small amounts of fat removed from a patient’s own belly. Such procedures have been used before, but long-term results vary and repeat injections may be necessary.

Voice quality, measured by testing and surveys, showed significant improvements starting a month after surgery and lasting a year.

When researchers tested vitality, social functioning, and whether physical or emotional problems interfered with a person’s normal role, the subjects were below normal compared to the general population before the surgery. Afterward, all aspects had improved significantly, aside from physical function.

Twenty-seven of the patients responded to a patient satisfaction surgery, and 24 of them said their experience was good, very good, or excellent.

However, the 33-patient study didn’t include a control group or comparison to another type of treatment, making it impossible to say whether the procedure is any better than other treatment strategies.

The study shows, the researchers conclude, that fat injection “is a feasible treatment to improve not only voice but also quality of life outcomes.”

SOURCE: http://archotol.ama-assn.org/cgi/content/short/136/5/457 Archives of Otolaryngology-Head and Neck Surgery

People who eat plenty of fish oil and other omega-3 fatty acids could cut their risk of colon cancer, new research hints.

Studies in animals and a couple of small trials in people suggest that fish oil supplementation can fight inflammation and may have cancer-fighting properties, Dr. Sangmi Kim of the National Institute of Environmental Health Sciences, Research Triangle Park, North Carolina, and colleagues note. But so far studies looking at the diets of larger groups of people have had equivocal results.

To investigate further, Kim and colleagues examined the relationship between polyunsaturated fatty acid intake and bowel cancer risk in 1,503 whites (including 716 colon cancer patients and 787 healthy controls) and 369 African Americans (213 with colon cancer, 156 controls).

Among whites, the researchers found, those in the top fourth based on their omega-3 consumption had half the risk of colon cancer compared to those in the bottom fourth.

When the researchers looked separately at the two main fatty acids contained in fish oil –eicosapentaenoic acids and docosahexaenoic acids — they found risk also fell with increasing intake.

When the researchers looked at whites and blacks together, they also found a reduced risk of colon cancer with increasing omega 3 intake; separate analysis of the black study participants didn’t find this relationship.

They also found that people who consumed more omega-6 fatty acids in relation to omega-3s were more likely to have colon cancer, although omega-6 intake in and of itself didn’t affect risk.

In addition to fish oils, omega-3 fatty acid sources include seed oils, such as walnut oil and flax-seed oils, and leafy green vegetables. People in the US typically eat more omega-6 fatty acids than omega-3s; top sources include palm oil, soybean oil, and sunflower oil.

The researchers also found an “unexpected” association between higher omega-3 intake and colon cancer in African-Americans, but urged caution in interpreting this finding, which they say “may have been due to chance.” Nevertheless, they conclude, “whether the possible benefit from this dietary modification varies by race warrants further evaluation.”

SOURCE: American Journal of Epidemiology.

Certain patients are far more likely than others to carry methicillin-resistant Staphylococcus aureus (MRSA), in their noses, a new study shows.

Although they are not infected with the potentially lethal germ, its mere presence heightens their risk of developing MRSA-related pneumonia, bloodstream infection and surgical site infection, the research concludes.

In the United States, about 1 percent of people carry MRSA in their nose. But this study of 2,055 patients found that MRSA was present in the noses of 20 percent of long-term elder care patients, 16 percent of HIV-infected patients, and 14 percent and 15 percent of inpatient and outpatient kidney dialysis patients.

“Hospitals performing active surveillance for MRSA should consider such patient populations for screening cultures,” study author Leonard Mermel, medical director of the department of epidemiology and infection control at Rhode Island Hospital, said in a news release.

USA100 — a health care-associated MRSA strain — was the most common MRSA strain detected in patients, but a more virulent community-associated strain known as USA300 was much more commonly found in HIV-infected patients, the researchers noted. They also detected some MRSA strains not previously identified in the United States, including an MRSA clone common in Brazil.

There were huge differences in the number of MRSA colonies in the noses of the patients in the study. Some had as few as three colonies of MRSA while others had as many as 15 million colonies.

“This finding is important because heavy MRSA colonization of the nose is an independent risk factor for the development of a surgical site infection,” Mermel said.

Further research is needed to learn why people have different strains and quantities of MRSA in their noses, Mermel said.

The study appears online and in the June print issue of the journal Infection Control and Hospital Epidemiology.

SOURCE: Rhode Island Hospital, news release.

Martial arts training appears to be a safe way to teach osteoporosis patients how to reduce the risk of injury when they fall, a new study suggests.

Researchers in the Netherlands studied the potential benefits of fall training in six healthy people.

“For obvious safety reasons, this could not be directly assessed using persons with osteoporosis. Therefore, we measured the hip impact forces during the martial arts fall exercises in a group of young adults,” researcher Brenda Groen said in a news release.

“Based on our results … we believe that fall training would be safe for persons with osteoporosis if they wear hip protectors during the training, perform fall exercises on a thick mattress, and avoid forward fall exercises from a standing position,” she said.

The volunteers in this study were taught how to turn a fall into a rolling movement by bending and twisting the torso and neck. These types of moves can be taught to older people, the researchers said.

“Since martial arts techniques reduce hip impact forces and can be learned by older persons, martial arts fall training may prevent hip fractures among persons with osteoporosis,” Groen concluded.

The study was published in the journal BMC Research Notes.

Health experts watching for signs of a malaria outbreak have noticed several cases of the mosquito-borne disease among people traveling back from Haiti, where an earthquake in January killed as many as 300,000 people.

So far, 11 laboratory-confirmed cases of malaria have been reported among emergency responders and those traveling in the United States from Haiti, the U.S. Centers for Disease Control and Prevention said on Thursday.

Haiti already had a problem with malaria, which is spread by mosquitoes that will have more places to breed in the cities and towns wrecked by the giant quake.

“Thus, displaced persons living outdoors or in temporary shelters and thousands of emergency responders in Haiti are at substantial risk,” researchers at the Pan American Health Organization and colleagues wrote in the CDC’s weekly report on death and disease.

Each year, Haiti reports about 30,000 confirmed cases of malaria to the Pan American Health Organization, but the CDC estimates as many as 200,000 may occur each year.

Three cases the CDC cited occurred among Haitian residents traveling to the United States and one case involved a U.S. resident who was visiting Haiti. All are expected to recover fully.

Six out of eight patients, including seven emergency responders, had been advised to take drugs to prevent malaria but had not done so, the PAHO experts said.

According to the CDC, malaria transmission peaks after the two rainy seasons — November to January and again during May to June.

There is no vaccine against the parasite that causes the illness and it quickly evolves resistance against drugs.

The CDC said the reported cases do not require a change in policy, but said anyone traveling to Haiti should take drugs to help prevent infection.

The CDC said it is continuing to monitor malaria in Haiti.

Researchers also are reviewing the use of nanomaterials for the treatment of melanoma. In particular, gold, when turned into a nanomaterial called nanoshells, has been shown to be a useful treatment for melanoma in animal studies.

According to Dr. Nasir, gold nanoshells can be engineered to absorb specific wavelengths of light. If the wavelength of light unique to a particular type of gold nanoshell is used on it, the particle generates heat. In one animal study done at MD Anderson Cancer Center in Houston, investigators joined gold nanoshells with a molecule which homes to melanoma. When these gold nanoshells are injected into mice harboring melanoma, the nanoshells accumulate in the cancerous tissue. When mice are illuminated with the proper wavelength of light, their tumors, laden with gold nanoshells, heat up and are effectively killed. The surrounding tissue, which lacks targeted gold nanoshells, is unharmed.

“Nanotechnology holds promise for new non-invasive treatment methods, particularly for challenging dermatologic conditions, such as atopic dermatitis and ichthyosis,” said Dr. Nasir.

Nanotechnology: More Consumer Information Needed
Because the skin is the first point of contact and the first line of defense for newly manufactured nanomaterials, Dr. Nasir noted that many dermatologists have concerns about the potential health risks posed by nanotechnology. “Although nanotechnology is an exciting area that holds enormous potential,” said Dr. Nasir, “we anxiously await the FDA’s review of the safety of nanoparticles which will determine their future role in skin cancer products.”

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.

Nanotechnology: On the Plus Side
Products incorporating nanotechnology are being developed and manufactured at an ever-growing rate, especially among clothing manufacturers that incorporate nanomaterials into fabrics to enhance stain and wrinkle resistance, and water repellence. However, Dr. Nasir explained that a substantial proportion of patents issued for nanotechnology-based discoveries are currently in the realm of cosmetic and consumer skin care products. In fact, the cosmetic industry leads all other industries in the number of patents for nanoparticles, which have the potential to enhance sunscreens, shampoos and conditioners, lipsticks, eye shadows, moisturizers, deodorants, after-shave products and perfumes.

One example of how nanoparticles are being considered for use is to improve some of the undesirable properties of skin care products. Dr. Nasir explained that when certain ingredients are included in micrometer-sized particles, which are considerably larger than nanosized particles, the result is a product than can be cosmetically unappealing.

For example, one common ingredient in broad-spectrum sunscreens, which protect the skin from both UVA and UVB rays, is avobenzone, which can make a sunscreen greasy and very noticeable when applied to the skin. Since titanium, another common sunscreen ingredient, requires an oily mixture to dissolve, a white residue can be apparent on the skin upon application. However, when these active ingredients in sunscreens are converted into nanoparticles, they can be suspended in less greasy formulations – which seem to vanish on the skin and do not leave a residue – while retaining their ability to block UVA and UVB light.

“While widespread use of this technology is currently under evaluation, I think one of the main benefits of nanoparticles used in sunscreens will be that the particles can fit into all the nooks and crannies of the skin, packing more protection and more even coverage on the skin’s surface than microsized particles,” said Dr. Nasir. “Since sunscreen formulations using nanoparticles may be more cosmetically appealing and seem to vanish when applied, consumers may be more inclined to use them on a regular basis.”

Nanotechnology also is generating excitement for its potential use in anti-aging products. When properly engineered, nanomaterials may be able to topically deliver retinoids, antioxidants and drugs such as botulinum toxin or growth factors for rejuvenation of the skin in the future.

In anti-aging products, Dr. Nasir added that nanotechnology may allow active ingredients that would not normally penetrate the skin to be delivered to it. For example, vitamin C is an antioxidant that helps fight age-related skin damage which works best below the top layer of skin. In bulk form, vitamin C is not very stable and is difficult to penetrate the skin. However, in future formulations, nanotechnology may increase the stability of vitamin C and enhance its ability to penetrate the skin.

“Since anti-aging products that contain nanoparticles of antioxidants will be harder to make, we expect that these products will cost more than products using traditional formulations,” said Dr. Nasir. “Once these products are determined to be safe, the consumer will have to decide if the increased costs are worth the added benefits.”