DiversityNursing Blog

BY MAGGIE FOX

www.nbcnews.com 

Hospital workers wash their hands hundreds of times a day. Nurses are constantly using alcohol gels, chemical wipes and iodine washes on themselves and on patients.

Now that there's a hand sanitizer dispenser at every hospital room door, it's time to check that they actually do work as well as everyone assumes and that they are safe, the Food and Drug Administration says.

So FDA issued a proposed plan Thursday for reclassifying some of the products, and for requiring makers to show they are safe and effective.

"We're not asking for any of these products to come off the market at this time."

In the meantime. FDA says, there's nothing for consumers to worry about and hospitals should continue using the products as they have been.

"What it seems they are doing is good due diligence," says Dr. Susan Dolan of Children's Hospital Colorado and the Association of Professionals in Infection Control.

"They are trying to look at the products, look at how they are being used today, how things have changed," she added.

The FDA proposes new rules making companies submit new studies looking at safety issues such as whether heavy, chronic use of the some of the products may cause them to soak in through the skin, or cause resistant bacteria to evolve.

Products that are not shown to be safe and effective by 2018 would have to be reformulated or taken off the market.

"We're not asking for any of these products to come off the market at this time. We're just asking for additional data," Theresa Michele, a director in FDA's drug center, said in an interview with The Associated Press. "And we're likewise not suggesting that people stop using these products."

Alcohol, iodine benzalkonium chloride and other germ-killers have been used for decades. But not to the degree that they are now.

"Twenty years ago you didn't find people using antiseptic gels 100 times a day. It just didn't happen," Michele said.

FDA points to studies that show some of the products might be absorbed into the body at higher levels than previously thought, showing up in blood and urine. Dolan says not all the studies show this, but it's worthwhile doing more checks.

"It's timely and it makes sense," Dolan said. "I do think consumers should not be worried. These are very effective products."

The FDA last updated its review of health care hand cleaners in 1994.

"They are trying to look at the products, look at how they are being used today, how things have changed."

"We emphasize that our proposal for more safety and effectiveness data for health care antiseptic active ingredients does not mean that we believe that health care antiseptic products containing these ingredients are ineffective or unsafe, or that their use should be discontinued," FDA said in its announcement.

The agency agreed to complete its review after a three-year legal battle with the Natural Resources Defense Council, an environmental group that accused the FDA of delaying action on potentially dangerous chemicals. In 2013 the FDA agreed to a legal settlement that included timetables for completing the review of various chemicals, including health care cleaners.

Environmentalists are mainly concerned about an ingredient called triclosan, which is used in most antibacterial soaps marketed to consumers. The agency issued a separate review of triclosan-containing consumer products in late 2013, saying more data are needed to establish their safety and effectiveness.

www.foxnews.com 

After roughly 40 years, U.S. health regulators are seeking data to see if the cocktail of ingredients in antiseptics used in hospitals, clinics and nursing homes are as safe and effective as they were once considered.

The Food and Drug Administration said on Thursday it is asking manufacturers for more data, including on absorption, potential hormonal effects and bacterial resistance of thehe 'active' ingredients in antiseptics, to see if they are still appropriate for use in a health care setting.

Since the review of health care antiseptics in the 1970s, things have changed, the FDA noted, alluding to a shift in frequency of use, hospitals' infection control practices, technology and safety standards. (1.usa.gov/1EUrzCd)

An independent panel of experts to the FDA raised similar concerns last year. In 2013, the regulator issued a warning to manufacturers, saying it was aware of at least four deaths and multiple infections caused by over-the-counter antiseptics. (1.usa.gov/1DNxOSp)

Commonly used active ingredients in health care antiseptics include alcohol and iodine. Data suggests that, for at least some of these ingredients, the systemic exposure is higher than previously thought, the agency noted.

"We're going to try to answer their questions in great detail as called for, but we believe the FDA already has sufficient data on these products," said Brian Sansoni, a spokesman for American Cleaning Institute (ACI), a trade association for the cleaning products industry.

The FDA said no health care antiseptics were going to be pulled off shelves as of now, and that their review excluded home-use antiseptics such as antibacterial soap and hand sanitizers.

The new data request relates only to health care antiseptics covered by the over-the-counter monograph, a kind of "recipe book" covering acceptable ingredients, doses, formulations and labeling. Once a final monograph is implemented, companies can market their product without having to go through the FDA.

Companies will have one year to submit the data, which the FDA will evaluate before determining if the OTC monograph needs to be revised.

"We're concerned if the FDA takes maybe a too narrow view regarding the safety and effectiveness data – depending how the final rule ends up – they could take effective products or ingredients off the shelves," Sansoni said.

By ANDREW POLLACK

www.nytimes.com 

A Silicon Valley start-up with some big-name backers is threatening to upend genetic screening for breast and ovarian cancer by offering a test on a sample of saliva that is so inexpensiv e that most women could get it.

At the same time, the nation’s two largest clinical laboratories, Quest Diagnostics and LabCorp, normally bitter rivals, are joining with French researchers to pool their data to better interpret mutations in the two main breast cancer risk genes, known as BRCA1 and BRCA2. Other companies and laboratories are being invited to join the effort, called BRCA Share.

The announcements being made on Tuesday, although coincidental in their timing, speak to the surge in competition in genetic risk screening for cancer since 2013, when the Supreme Court invalidated the gene patents that gave Myriad Genetics a monopoly on BRCA testing.

The field has also been propelled by the actress and filmmaker Angelina Jolie, who has a BRCA1 mutation and has written about her own decision to have her breasts, ovaries and fallopian tubes removed to sharply reduce her risk of developing cancer.

But the issue of who should be tested remains controversial. The effort of the start-up, Color Genomics, to “democratize access to genetic testing,” in the words of the chief executive, Elad Gil, is generating concern among some experts.

The company plans to charge $249 for an analysis of BRCA1 and BRCA2, plus 17 other cancer-risk genes. That is one tenth the price of many tests now on the market.

Testing of the BRCA genes has generally been limited by medical guidelines to women who already have cancer or those with a family history of breast or ovarian cancers. Insurers generally have not paid for BRCA tests for other women, and some insurers are not paying at all for a newer type of screening known as a panel test that analyzes from 10 to 40 genes at once.

Dr. Gil of Color said his company’s test would be inexpensive enough for women to pay out of pocket, so that neither the woman nor Color will have to deal with insurance companies. He said the company was starting a program to provide free testing to women who cannot afford its test.

One of the company’s unpaid advisers is Mary-Claire King, the University of Washington geneticist whose work led to the discovery of the BRCA1 gene. Dr. King last year publicly called for testing to be offered to all American women 30 and older.

She said that half the women with dangerous mutations would not qualify for testing under current guidelines, in part because many inherit the mutation from their fathers rather than their mothers and a family history of breast or ovarian cancer might not be evident.

But other experts say that fewer women in the expanded group would be found to have dangerous mutations, raising the overall cost of testing per cancer case prevented. Moreover, expanded testing could result in many more women being told they have mutations that cannot be classified as either dangerous or benign, leaving women in a state of limbo as to whether they have an increased risk of cancer.

“We have to be careful that we are not just increasing this group of worried-well who have incomplete information,” said Dr. Kenneth Offit, chief of the clinical genetics service at the Memorial Sloan Kettering Cancer Center.

Dr. Offit said it was contradictory that Color was trying to expand testing to everyone on the same day the two biggest testing companies were joining forces to try to reduce how often they find these so-called variants of uncertain significance.

Color is planning to allow women to order tests through its website. Another Silicon Valley start-up that did that, 23andMe, had its health testing shut down in 2013 by the Food and Drug Administration.

Color executives say that unlike with 23andMe, a doctor will be involved in every order and in the test results. If a consumer orders the test directly from its website, her information will be sent to a doctor hired by the company to evaluate it.

An F.D.A. spokeswoman said that if doctors place orders, testing companies that operate their own laboratories do not need F.D.A. approval to offer their tests.

Some testing experts question whether Color can provide testing as inexpensively as it claims. While the actual sequencing might be done for less than $250, that is only part of the cost, which also involves interpretation and working with patients and doctors, they say. Other companies generally charge at least $1,500 for complete analyses of the BRCA genes or for multigene tests.

But Dr. Gil said Color has highly automated its processes and will even offer genetic counseling to women. He said the company chose the saliva test rather than a blood one because it’s easier for users but still accurate. Women send the saliva sample to Color for testing.

Dr. Gil received a doctoral degree in biology at the Massachusetts Institute of Technology, studying a cancer gene. But he has spent much of his career at Google and Twitter. The company’s president, Othman Laraki, also worked at Google and Twitter.

Color’s backers — it says it has raised about $15 million — are mainly from the world of high tech rather than life sciences. Its lead investors are the venture capital firms Khosla Ventures and Formation 8. Individual investors include Laurene Powell Jobs, the widow of Steve Jobs; Susan L. Wagner, a co-founder of the investment firm BlackRock; Padmasree Warrior, the chief technology and strategy officer at Cisco; and Jerry Yang, co-founder of Yahoo.

Dr. Offit of Sloan Kettering said that even Myriad, which long had a monopoly on BRCA testing and has the most data, has reported having a 2 percent rate of variants of unknown significance, meaning 2 percent of the time it cannot tell if a variant in a gene increases the risk of cancer or is benign. Other companies might have higher rates. And the rates for some other, less-well-studied genes can be 20 or 30 percent, he said.

The entire testing industry is now scrambling to pool data to lower that rate, and in some cases to catch up to Myriad, which has kept much of its data proprietary as a competitive advantage. Various data-sharing efforts are already underway, including by ClinVar and the BRCA Challenge.

Now there is also BRCA Share, which is based on a database of genetic variants maintained by Inserm, a French government health research institute. Quest Diagnostics agreed to provide money to improve that database and pay for experiments on cells that could help determine whether certain mutations raise the risk of cancer.

“We are going to help them make it better,” said Dr. Charles M. Strom, vice president for genomics and genetics at Quest. He said BRCA Share would be open to others, with LabCorp becoming the first to join.

Participants will have to contribute their data to the database. Companies will pay for access to the data on a sliding scale based on their size, while others will have access to the data without paying, he said.

The Food and Drug Administration has approved the use of an attention deficit/hyperactivity disorder drug to treat binge eating.

Should ADHD medication be prescribed to help cut compulsive overeating?

The drug, Vyvanse, is usually used for ADHD but it's been shown to help control binge-eating disorder, the FDA said.

"In binge-eating disorder, patients have recurrent episodes of compulsive overeating during which they consume larger amounts of food than normal and experience the sense that they lack control. Patients with this condition eat when they are not hungry and often eat to the point of being uncomfortably full," the FDA said in a statement.

"Patients may feel ashamed and embarrassed by how much they are eating, which can result in social isolation. Binge-eating disorder may lead to weight gain and to health problems related to obesity."

The drug is not approved for weight loss, and it's a Schedule II controlled substance because it has high potential for abuse and dependence. But any doctor can write a prescription for any approved drug for any use he or she sees fit.

"The concern in our country especially is the desperation to lose weight," said NBC's diet and nutrition editor Madelyn Fernstrom. "Everyone will say, 'Oh, I have binge eating disorder'. I think there's a huge potential for abuse in our country."

Source: www.nbcnews.com

Gay men who've abstained from sex for one year would be able to donate blood in 2015, ending a lifetime ban for the gay community, under a proposed FDA policy change unveiled Tuesday.

The current lifetime ban by U.S. Food and Drug Administration states dates back to 1983 and forbids men who have had sex with men from becoming blood donors because the group is "at increased risk for HIV, hepatitis B and certain other infections that can be transmitted by transfusion," the FDA has ruled.

But the FDA is now seeking a change in that policy and would allow such blood donations based on an independent expert advisory panel's recommendation, the agency said.

The proposed change would align the one-year deferral period "with that of other men and women at increased risk for HIV infection," the FDA said.

The agency will be gathering public comments on the proposed change.

"We encourage all stakeholders to take this opportunity to provide any information the agency should consider, and look forward to receiving and reviewing these comments," FDA Commissioner Margaret A. Hamburg said in a statement.

The National Heart Lung and Blood Institute and the FDA would monitor a national blood surveillance system to see any effects of the proposed policy change and to ensure the continued safety of the blood supply, Hamburg said.

"A history of male-to-male sex is associated with an increased risk for exposure to and transmission of certain infectious diseases, including HIV, the virus that causes AIDS," the FDA said. Men who have had sex with other men represent approximately 2% of the U.S. population, yet are the population most severely affected by HIV, according to the FDA.

In 2010, male-to-male sex accounted for at least 61% of all new HIV infections in the United States, and "an estimated 77% of diagnosed HIV infections among males were attributed to male-to-male sexual contact," the FDA said.

Source: www.cnn.com

By Linda Carroll

For years Larry Hester lived in darkness, his sight stolen by a disease that destroyed the photoreceptor cells in his retinas. But last week, through the help of a “bionic eye,” Hester got a chance to once again glimpse a bit of the world around him.

Hester is the seventh patient to receive an FDA-approved device that translates video signals into data the optic nerve can process. The images Hester and others “see” will be far from full sight, but experts hope it will be enough to give a little more autonomy to those who had previously been completely blind.

Hester’s doctors at Duke University Eye Center believe that as time goes on the 66-year-old tire salesman from Raleigh, N.C., will be able to “see” more and more. After only five days, there has been remarkable progress.

“I hope that [after some practice] he will be able to do things he can’t do today: maybe walk around a little more independently, see doorways or the straight line of a curb. We don’t expect him to be able to make out figures on TV. But we hope he’ll be more visually connected.” said Dr. Paul Hahn, an assistant professor of ophthalmology at the university in Durham.

It was at Duke three decades ago that Hester learned that something was seriously wrong with his eyes. After a battery of tests, doctors delivered the disheartening news: Hester had retinitis pigmentosa, a disease that would inexorably chip away at the rods and cones in his retinas, eventually leaving him blind.

“It was a pretty devastating blow, frankly,” Hester said. “I was 33 at the time.”

But Larry Hester wasn’t the sort of guy to sit around feeling sorry for himself. With the support of family, friends and a devoted wife, he found a way to live his life as normally as possible, depending on his memory to help him navigate around his home and his workplace.

One day his wife, Jerry, saw a story about a device that might help Larry. The FDA had just approved it for use in people who suffer from the same condition as Larry —some 50,000 to 100,000 in the U.S.  

Larry was just the kind of patient that Hahn was looking for to try out the Argus II Retinal Prosthesis system, and he became the first to get the device at Duke.

Argus was designed to bypass damaged photoreceptors and send signals directly to the next layer of retinal cells, which are on the pathway to the optic nerve.

A miniature video camera seated in a pair of glasses captures what the patient is “looking” at and sends the video through a thin cable to a small external computer that transforms the images into signals that can be understood by that second layer of retinal cells. Those data are then sent back to the glasses, which transmit the information through a small antenna to an array of 60 tiny electrodes that implanted up against the patient’s retina.

The electrodes emit small pulses of electricity that make their way up the undamaged retinal cells to the optic nerves, creating the perception of patterns of light. The hope is that patients will learn to interpret those patterns as images.

Last week with the new glasses perched on his nose, Larry sat in a chair at Duke surrounded by medical staff and his family — all waiting for Hahn to turn on the device. Directly in front of Larry was a brightly lit screen.

“At the count of three, we’re going to hit the start button and we’ll see what happens,” Hahn said.

At three, a smile started to play on Larry’s lips.

“Yes,” he said and the smile broadened across his face. “Oh my goodness!”

Jerry looked at him and exclaimed, “Can you see, Larry?”

After giving her husband a kiss, she asked again, “Can you really see?”

“Yes. Flashing. Big time flashing.”

Experts see the new device as the start of something big.

“It’s a fairly limited device, but it’s an amazing leap forward,” said Dr. Colin McCannel, a retinal expert at the Jules Stein Eye Institute at the University of California, Los Angeles. “It’s not the vision you or I are used to. But for someone who has been in complete darkness it must be amazing to see again. I think it’s absolutely phenomenal.”

Dr. Neil Bressler turns to the space program for an analogy.

“It’s like the first rocket ship that went up and down, or when John Glenn went into orbit,” said Bressler, a professor of ophthalmology and chief of the retina division at Johns Hopkins Medicine. “If you asked can we put a man on the moon the next day the answer would be no. It was the first of many steps to achieve the objective of putting a man on the moon.”

While the device isn’t even close to giving Larry back the vision he was born with, he can see contrasts, which allows him, for example, to distinguish between a white wall and a darkened doorway.

If you’ve lived in darkness for decades, that little bit of new-found vision can be a huge gift.

“The other night I was sitting on a dark leather chair,” Jerry said. “He was able to scan over and see my face because it was lighter. And he reached out and touched my face. That is the first time he had done that in a long time. It was a sweet and precious moment.”

Linda Carroll is a regular contributor to NBCNews.com and TODAY.com. She is co-author of "The Concussion Crisis: Anatomy of a Silent Epidemic” and the recently published “Duel for the Crown: Affirmed, Alydar, and Racing’s Greatest Rivalry.”

Source: www.today.com

By Associated Press

WASHINGTON (AP) — Federal health regulators have approved a first-of-a-kind set of robotic leg braces that can help some disabled people walk again.

by Stephanie Baum

As people in towns and cities across the U.S. feel the clammy grip of the flu epidemic, several biotechnology startups and Big Pharma companies are using innovative technology to develop different approaches to combating influenza and developing vaccines to combat multiple flu strains. Here are five of them:

Nasal spray: NanoBio Corp‘s flu vaccine is a nasal spray designed to offer short-term infection prevention and reduce transmission of the virus between humans. It uses nanoemulsion technology to develop a seasonal flu vaccine nasal spray. Currently in phase 2 development, the technology uses an oil-in-water emulsion to rapidly penetrate through pores and hair shafts to the site of an infection, and physically disrupt the outer membrane of pathogenic organisms by fusing with the invading flu virus and killing it before infection occurs. It would be used at times when there is a high risk of exposure such as air travel, a pediatrician’s office visit, hospital or any situation where groups of people congregate, according to the company’s website.

Combating more strains: The U.S. Food and Drug Administration approved GlaxoSmithKline’s quadrivalent vaccines last month. The vaccines contain two influenza A strains and two influenza B strains to potentially help broaden protection against seasonal influenza. It is approved for use in children 3 years of age and older. Current flu vaccines generally protect against three strains of influenza: two A strains and one B strain.

Universal vaccines: Biotechnology startup Visterra is developing a monoclonal antibody for universal flu vaccine VIS410 that could not only cover the three most common seasonal strains the widely available flu vaccines protect against, but also more deadly strains like the H1N1 variation.

Cross-strain protection: Inovio is developing a universal flu vaccine that would induce both preventive antibody and T-cell immune responses for cross-strain protection against known and new, unmatched viruses. It could be especially helpful for the elderly who are among those most vulnerable to contracting the flu. It is developing a seasonal flu vaccine as well as one that could combat a pandemic.

Egg alternative: One problem with flu vaccines on the market is that they are developed from fertilized chicken eggs, which makes them off limits to those with egg allergies. A new seasonal flu vaccine from Novartis using cultured animal cells won FDA approval in November. It will be marketed under brand name Flucelvax.