How much do you know about the food you eat? Consumers are starting to open their eyes and taking a stand on the blinds the FDA (U.S Food and Drug Administration) and companies like Nestle, Bertoli, General Mills, and Pepperidge Farms try to pull on us.

Genetically Modified Organisms (GMOs) are present in the vast majority of processed foods found in most stores around the country. The Grocery Manufacturers Association estimates that between 75% and 80% of all processed foods available on grocery store shelves contain GMOs.

Recently there have been so many cases in the United States cracking down on the amount of GMOs that goes into our food, fish markets selling “fake fish” in New York City and even the most recent case of 15-year-old Sarah Kavanagh who started a petition against PepsiCo against the drink Gatorade.

The New York Times reported that Ms. Kavanagh, a dedicated vegetarian, read the label while drinking Gatorade and one peculiar ingredient caught her eye; vegetable oil. This pushed her to do further research and then she decided to start a petition on Change.org that has almost 200,000 signatures already. Her campaign is a way to persuade companies like PepsiCo to consider changing the drink’s formulation.

Brominated vegetable oil contains bromine, an element contained in things like upholstered furniture and children’s products. Research has found that a build-up of this element in both human and animals can cause “neurological impairment, reduced fertility, changes in thyroid hormones and puberty at an earlier age.”

Despite this, brominated vegetable oil has been deemed safe for consumption by federal regulators, says The New York Times.

Up to 10% of drinks sold in the United States contain brominated vegetable oil, including Mountain Dew, Powerade, Fanta Orange, Squirt and Sunkist Peach Soda.

“B.V.O. is banned other places in the world, so these companies already have a replacement for it,” Ms. Kavanagh told The New York Times. “I don’t see why they don’t just make the switch.” To that, companies say the switch would be too costly.

Currently in the United States, companies are not required to tell you if there are GMOs in the food they sell. Food companies can basically put whatever they chose to in your food. As long as it is “said” to be safe, they will use it without your knowledge.

Toonari Post contacted Nature Valley, a product of General Mills, by email and phone to ask why they use GMOs but claims on their website and Facebook page, “No matter how many flavors we create, they’re all made like the first, from wholesome, delicious ingredients. That way you can be assured that with Nature Valley you’re always getting The Taste Nature Intended.”

Amy Sadowski, Consumer Services representative for Nature Valley responded by email, ” For that reason, the FDA does not require special labeling for it. Because of the growing use of biotechnology by farmers and the way that grain gets commingled in storage and shipment, it′s certainly possible that some of our products may contain ingredients that have been improved through biotechnology. We can assure you, though, that every major regulatory agency, as well as independent scientific groups like the American Medical Association, has concluded that these ingredients are safe. General Mills also believes in providing consumers with a variety of food options. Toward that end, we do offer organic products that, by definition, do not use ingredients that have been improved through biotechnology. Please look for organic Gold Medal flour and a wide range of products from our Cascadian Farm and Muir Glen brands.”

So how can you protect yourself from food with GMOs and false organic labeling claims?

Avoiding corn and soy products that are not explicitly labeled as 100% Organic is a good first step in avoiding GMOs. According to the USDA Organic Program standards, organic foods cannot contain any genetically modified organisms. However, a company can still market a product as being made from organic ingredients while using some GMOs. If it is not labeled as being 100% organic, then it is likely to only contain a mixture of organic and non-organic agricultural ingredients.

You can also log on to Facebook and like the Label It Yourself page to see what foods to avoid.

In the end, there is no certifiable, authoritative, or inclusive list of foods that absolutely contain GMOs. The best thing to do is read before you eat, make the choice to shop at a local “mom and pop” organic health food store or shop at your local farmer’s market to play it safe.

The article More Garbage on Your Food Shelves than Your Landfills appeared first on The Toonari Post - News, Powered by the People!.

Vancouver, Canada — With FDA approval of a brain amyloid imaging compound in early 2012 and the expected start in 2012 and 2013 of three clinical trials in people with pre-symptomatic Alzheimer’s disease, issues around disclosure of dementia risk status are becoming more urgent. Several research efforts have been reported at the Alzheimer’s Association International Conference describing the creation and evaluation of new risk disclosure methods, and the examination of related ethical issues.

Alzheimer’s is a devastating, progressive, and fatal illness. There is a movement in the Alzheimer’s research field to detect and treat the disease earlier – even before there are outward symptoms – so that people do not have to suffer from the debilitating memory and thinking problems that lead to loss of normal daily activities and independence, and eventually death.

A number of Alzheimer’s prevention trials are in the planning stages. They will be conducted in people without memory or thinking symptoms who are considered at-risk for Alzheimer’s on the basis of genetic and/or biomarker positivity.

A biomarker is something in the body that can be measured as an indicator of normal biological processes, disease processes, or changes in response to therapy. For example, cholesterol levels are a biomarker for heart disease. A variety of imaging and fluid biomarkers are under investigation in Alzheimer’s disease. Biomarkers allow investigators and clinicians to detect Alzheimer’s-related changes in the brain and other body systems prior to the onset of dementia symptoms due to Alzheimer’s.

“Biomarkers are being increasingly used in clinical practice and research trials to provide risk information for Alzheimer’s. The goal is to develop evidence-based methods for communicating this risk in effective and supportive ways,” said J. Scott Roberts, Ph.D., of the University of Michigan, School of Public Health. Dr. Roberts is chair of an AAIC 2012 featured research session where new research on disclosing risk information will be reported and discussed.

One of the most promising biomarkers is brain imaging using positron emission tomography (PET) scans that can show whether a person has deposits of an abnormal protein called beta amyloid, which is one of the hallmarks of Alzheimer’s disease. There also are well-established genetic risk factors, such as the APOE Alzheimer’s risk gene.

Based on current knowledge, APOE-e4 is the gene with strongest impact on Alzheimer’s risk. APOE-e4 is one of three forms of the APOE gene; the others are APOE-e2 and APOE-e3. Everyone inherits a copy of APOE from each parent. Those who inherit one copy of APOE-e4 have an increased risk of developing Alzheimer’s. Those who inherit two copies have an even higher risk, but not a certainty. Scientists estimate that APOE-e4 is implicated in about 20 to 25 percent of Alzheimer’s cases. APOE-e2 may provide some protection against Alzheimer’s.

Until recently, the presence of brain amyloid could only be confirmed by autopsy. Now it is possible to look for the protein in living brains using a special type of dye during a PET scan. These PET scans may help determine whether or not a person who is experiencing memory loss has Alzheimer’s disease.

“People with memory loss who test negative on a PET scan using the newly-approved dye do not have Alzheimer’s disease,” said William Thies, Ph.D., Alzheimer’s Association Chief Medical and Scientific Officer. “Their symptoms are caused by something else. If they test positive, the cause is likely Alzheimer’s, but that is not 100% certain because the presence of amyloid can be detected in other diseases besides Alzheimer’s. We do not yet know what the test means in people without symptoms. The predictive value of the test is uncertain.”

“The disclosure of test results to cognitively normal older people raises some important ethical issues because researchers and clinicians do not yet know how to interpret them. How will this biomarker information be gathered? When, how, and to whom will it be disclosed? How do we disclose it accurately while minimizing any potential negative impact? These are issues that must be addressed by the research and healthcare communities, with crucial input from Alzheimer’s families and other stakeholders,” Thies added.

The Alzheimer’s Association currently is working with the Society of Nuclear Medicine to develop guidelines for when an amyloid PET scan is appropriate and how it should be interpreted.

Disclosing Alzheimer’s disease genetic risk to people with MCI

The Risk Evaluation and Education for Alzheimer’s Disease Study (REVEAL) is a multi-center randomized clinical trial enrolling people with mild cognitive impairment (MCI) to investigate the impact of disclosing “imminent” Alzheimer’s disease risk information – specifically, the probability of progressing to Alzheimer’s within the next three years. The trial tests different methods for disclosing this information, including a method where genetic testing is used to refine the risk estimates given to study participants.

“We hope to learn how people with MCI and their study partners respond to health education and learning risk information,” said Robert C. Green, M.D., MPH, of Brigham and Women’s Hospital and Harvard Medical School. “We continue to evaluate how well participants understand the Alzheimer’s risk assessment and what they do with the information. We’re monitoring how the people with MCI and their care partners adjust psychologically and what health related and behavioral changes they make in response to the new information.”

Green and colleagues designed and are implementing an evidence-based procedure for risk estimation and an experimental trial of APOE genotype disclosure in people age 55 to 90 with MCI and their study partners recruited at four university medical centers (Harvard, Univ. of Michigan, Univ. of Pennsylvania, and Howard). Participants receive risk estimates for their chance of progressing to Alzheimer’s disease that are based on their age, MCI diagnosis and APOE genotype (intervention arm) or age and MCI diagnosis alone (control arm). Risks disclosed to participants range from 8-57% in the intervention arm and 25-44% in the control arm.

The research team developed graphics and language to facilitate communication of APOE genotype and numerical risk estimate. Both participants with MCI and their study partners are followed up to 6 months following risk disclosure to determine its impact on caregiver distress, health behavior, and insurance/lifestyle changes. To inform further development of educational materials, researchers will also evaluate how well participants understood the information that was provided to them.

“This is the first study to examine the impact of disclosing Alzheimer’s genetic risk information to individuals with MCI,” Green said. “We believe the findings from REVEAL will have important implications for clinicians and policy makers in informing the future practice of educating and treating people at risk for Alzheimer’s.”

Disclosing brain amyloid imaging results to people with MCI and their families

Brain amyloid imaging is increasingly recognized as a powerful tool for predicting whether people with MCI will transition to Alzheimer’s disease.  As this technology moves from the research setting into clinical practice, an emerging concern is that people with MCI may have difficulty comprehending their test results.

Given the lack of research on disclosing this information to people with cognitive impairments, Jennifer Lingler, Ph.D., of the University of Pittsburgh, Pennsylvania, and colleagues conducted a study to develop a standardized procedure for effectively communicating amyloid imaging results in the context of MCI, which is often described as an intermediate state between normal cognitive aging and Alzheimer’s.

Based on previous research and insights from a panel of experts in neuroimaging, neuropsychology, risk communication, regulatory affairs, and bioethics, Lingler developed scripts and visual aids that guide clinical researchers in disclosing positive, negative, or inconclusive amyloid scan results. Ten people with MCI and 10 of their family members participated in mock results disclosure sessions and provided feedback on the procedure.

The researchers found that:

• The great majority of participants reported that the session was “easy to follow,” (19 of 20) “included just about the right level of detail,” (17 of 20) and was “just about right” in length (17 of 20).
• All 20 participants rated the information as “clearly presented.”
• Eight of the 10 family members and seven of the 10 people with MCI correctly repeated their mock results back to an interviewer after the session.
• Analysis of interview data from the five participants with questionable comprehension suggested that (a) cognitive factors may explain problems with comprehension among those with MCI, while (b) emotional factors may underlie problems with comprehension among family members.

“Our study demonstrates that it is possible to provide people with MCI and family members with highly comprehensible and acceptable information about their brain imaging results of Alzheimer’s risk,” Lingler said. “However, since some of the participants had some difficulty, we recommend that a family member or friend be present, and that emotional support be provided, when imaging results are discussed.”

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New York, U.S.A. — In a recent interview for Fox News, Martin Smithmyer, CEO of Americord Registry, one of the industry’s leading cord blood banking companies, said, “Although [Americord] does not pay doctors for making referrals, this is a common practice among some of our competitors, including at least 3 of the top 6 cord blood banks.”

The Obama administration, in January 2012, made it clear that under the new health care law it will require certain healthcare companies to disclose payments they make to doctors – sometimes amounting to hundreds of thousands or even millions of dollars – for research, consulting, speaking, travel and entertainment. The American Congress of Obstetricians and Gynecologists (ACOG), recommends doctors disclose such payments and arrangements to patients.

Furthermore, according to Smithmyer, cord blood has certain limitations that parents should know about before they decide to bank their child’s cord blood, since the cost of cord blood banking is not an insignificant consideration when making this decision.

“Although in this field the technology is always changing, the number of stem cells in one unit of cord blood today is only sufficient to treat a child up to about 10 years old,” said Smithmyer. Americord Registry is developing a new technology that will collect up to 10 times more stem cells. This would be enough to use therapeutically for an adult. To learn more, read the full article from Fox contributor: 7 things you should know about cord blood banking.

About Americord Registry

Americord Registry is a company involved in umbilical cord blood, cord tissue and placenta stem cell preservation. Americord collects, processes, and stores newborn stem cells for future medical and therapeutic use, including the treatment of more than 80 diseases such as leukemia.

Founded in 2008, Americord is registered with the Food and Drug Administration. The company’s laboratory is accredited by the AABB and complies with all federal and state regulations, including federal CLIA laboratory standards. Americord is based in New York, NY.

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New York, U.S.A. — The July 9 New York Times article, “More Women Look Over the Counter for a Libido Fix,” by Abby Ellin is a story about how a low sexual libido is surprisingly common in young women and how the marketplace is starting to respond to women’s plight for sexual enhancement products.

“With the recent advent of media bringing female sexuality to the forefront such as the book 50 Shades of Grey and the film ‘Magic Mike,’ a women’s sex drive, which until recently was not a family-friendly topic is now water cooler conversation. Women are no longer ashamed to talk about their sex lives or their desire to improve them,” said Dr. Michael L. Krychman, Executive Director of the Southern California Center for Sexual Health and Survivorship Medicine.

Rachel Braun Scherl, president of Semprae Laboratories, the manufacturer of Zestra explains, “There are a number of factors that will lower a women’s libido, desire, arousal or satisfaction, many of which are not age-specific. These include side effects from medications including oral birth control and anti-depressants; hormonal changes due to post pregnancy or menopause; the physiological and emotional impact of cancer treatment; realities and side effects of medications for a number of medical conditions including diabetes, obesity and MS; and the all-encompassing stress.”

In the absence of an FDA approved female counterpart to men’s sexual satisfaction drugs like Viagra, Cialis and Levitra, many women are turning to over-the-counter products, including lubricants, arousal gels, massage oils, nutritional and herbal supplements, and vibrators.

Chain stores, including drugstores, are now selling these products. Zestra Essential Arousal Oils, for example, is now sold in 1,800 Wal-Mart’s, up from 880 in 2010, as well as Kmart, Rite Aid and Meijer. Rachel Braun Scherl explains, “Clearly, women and men are asking for these products. Zestra has kept its retail shelf space with just one retail product (although broader range is available online).”

Zestra’s second double-blind clinical study, the only study of its kind to be printed in a medical journal, was conducted with women 21 to 65 demonstrating that Zestra, a blend of botanical oils and extracts, worked equally effectively for women of all ages and reproductive life stages.

Female sexual dysfunction becomes an official diagnosis (to be called female sexual interest/arousal disorder) in the DSM-V, the new edition of the psychiatric diagnostic manual, due in 2013.

Still, the proliferation of these sexual enhancement products — and their emphasis on fixing a problem that is extremely hard to define — leaves some people worrying that women will start focusing on so-called trouble spots and putting pressure on themselves to perform. Rachel Braun Scherl advises, “Our idea is not to get women to have more sex — not that there is anything wrong with that — it’s that if they’re having sex they should enjoy it.”

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Halifax, U.S.A. — Under a US Army contract valued at USD$4.2 million, MedMira will develop and commercialize this multiple rapid test which detects HIV, Hepatitis B and C simultaneously in 3 minutes from a single drop of blood.

MedMira Inc., a developer of rapid diagnostic technology and solutions, announced today that it has been awarded a U.S. Army Medical Research Acquisition Activity (USAMRAA) contract to develop and commercialize a rapid test capable of simultaneous detection of HIV and Hepatitis B and C.

The contract, awarded through a competitive bid process, involves a two-year base period and a 10-month option with a value of USD$4,266,144, if all options are exercised. MedMira presented its technology and multiple rapid tests, which met the U.S. Army’s advanced technology readiness level requirements. The Multiplo Rapid HBV/HIV/HCV Antibody Test resulting from this contract award will be deployed on the frontlines of military healthcare for use in emergency screening for transfusion transmitted diseases where no FDA approved donor screening tests are available. The military could also put the test to use during pre and post deployment screenings and civilian disaster relief efforts.

“We are thrilled to receive this new contract from USAMRAA for the development and commercialization of our Multiplo test. This contract award demonstrates the excellent fit between MedMira’s technology and products and military requirements. We have built a lasting relationship with the U.S. Army, delivering advanced diagnostic solutions that reduce the need for militaries to undertake ground-up development work,” said Hermes Chan, CEO, MedMira Inc. “MedMira’s technology and products are elegantly simple, portable, fast, and high quality. All of these attributes are mission critical in deploying diagnostic healthcare solutions on the frontlines of military healthcare.”

Chan continued, “Our team recently attended a conference focused on military pre-hospital trauma management where we heard first hand of the need for a multiple rapid HBV/HIV/HCV test from many of the leading experts, military personnel, and medical professionals in this field.”

Under contract number W81XWH-12-C-0151 the U.S. Army will fund all development costs and associated fees in obtaining a U.S. Food and Drug Administration (FDA) premarket approval (PMA) for this multiple rapid test. The scope of work under this contract will see MedMira advance and fully commercialize a multiple rapid test that will simultaneously detect three of the most serious infectious diseases, namely HIV-1/2, Hepatitis B, and C antibodies within three minutes using just a small drop of blood. Once approved, the product will be supplied by MedMira directly to the U.S. Army and to other customers throughout the world, both military and civilian, via the Company’s distribution network.

“A multiplexed test for transfusion transmitted diseases provides an enabling technology that will be used to mitigate risk in austere environments where emergency blood collections are necessary to save lives of severely wounded war fighters,” said Colonel Richard Gonzales, Product Manager, U.S. Army Medical Materiel Development Activity.

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Back in August 2010, after a salmonella outbreak spread across the nation, there was an egg recall of 550 million eggs. Newly released records during a civil lawsuit underway in a Federal Court in California show the owner of the egg company involved knew the hens were contaminated with salmonella months before the recall.

According to the Associated Press, the egg mogul Jack DeCoster and his companies asked Iowa State University’s Veterinary Diagnostics Laboratory to test for salmonella back in January 2010. The company was preparing for federal rules set to take effect in July which required mandatory testing for the bacteria at different stages of production. In January 2010, testing began by collecting samples from DeCoster’s plants.

ISU scientist Darrell Trampel wrote in an email, “If SE is in the livers of the laying hens, it is almost certainly in the eggs at this site,” calling it “a very interesting finding.”

In April, ISU’s Veterinary Diagnostics Lab found traces of salmonella in manure at several Iowa egg-laying plants and internal organs of birds, which were dying at unusually high rates. The scientist found that 43 percent of the poultry houses tested positive for salmonella.

The third-party laboratory released its records due to a subpoena from NuCal Foods, a California company suing DeCoster and his companies in federal court. NuCal bought some of the tainted eggs and later had to recall them, being faced with lawsuits from customers who got sick and lost profit after the salmonella outbreak.

“Our role is to provide a third-party quality assured diagnostic service, and it’s up to the client to interpret the information,” said the lab’s operation director, Roger Main, whose 125-employee lab receives $3.2 million in Iowa tax dollars and conducts about 1 million tests every year.

The laboratory reported the findings of salmonella to the egg producer who requested the test alone, and say as a third-party they had no legal or ethical obligation to alert regulators or consumers.

The FDA now requires producers that find salmonella in the product to conduct more tests and destroy the bacteria or change the course of the contaminated eggs to non-food use.

According to the Associated Press, the lawsuit against DeCoster and his companies argues that they “did not initiate egg tests or salmonella decontamination” knowing they were not quality while continuing to sell the products. The lawsuit says the defendants hid the filthy conditions at their farms so that they could continue to profit.

DeCoster gave up control of the Iowa based egg company in 2011, releasing this statement to the Associated Press, “While we are committed to working to address outstanding issues related to the outbreak, it is important to note we no longer operate any of the farms involved and are no longer in the business of egg production.”

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Pasadena, U.S.A. – People who have had an episode of herpes zoster, also known as shingles, face a relatively low short-term risk of developing shingles again, according to a Kaiser Permanente Southern California study published online in the Journal of Infectious Diseases. These findings suggest that among people with immune systems that have not been compromised, the risk of a second shingles episode is low.

Researchers reviewed electronic health records and monitored recurrence of shingles for more than 6,000 individuals. They found fewer than 30 cases of recurrent shingles in an average of two years of follow-up and little difference in the rate of recurrence between the vaccinated and unvaccinated population.

“This study’s findings are important because we found that the risk of having a recurrent shingles episode is not as high as previous research indicates,” said Hung Fu Tseng, PhD, MPH, study lead author with the Kaiser Permanente Southern California Department of Research & Evaluation in Pasadena, California. “We now have empirical data that show the risk of recurrence is low among an elderly population who did not have compromised immune systems, regardless of their vaccination status.”

More than 1 million people develop shingles every year in the United States. Shingles is a painful contagious rash caused by the dormant chickenpox virus, which can reactivate and replicate, damaging the nerve system. The elderly are especially vulnerable because immunity against the virus that causes shingles declines with age.

When the Food and Drug Administration approved the shingles vaccine in 2006, the agency said that having an episode of shingles boosts immunity and suggested it was unlikely that people would experience a recurrence. It further stated that the effectiveness of the vaccine in preventing repeat episodes had not been proven in clinical trials because trials have not been conducted.

By contrast, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices recommended the herpes zoster vaccine for people ages 60 and older, including those who reported a previous episode.

“While this latest study adds to the growing evidence base of emerging knowledge about the shingles vaccine, more research is needed. Our findings need to be replicated by studies with larger populations. Kaiser Permanente Southern California researchers will continue to follow this population of vaccinated people in order to determine the long term preventative efficacy,” said Dr. Tseng.

Researchers studied electronic health records for 1,036 vaccinated and 5,180 unvaccinated Kaiser Permanente members aged 60 and older. The vaccinated population included members who received vaccines between 2007 and 2010. The zoster vaccine is not recommended for patients with immune systems that have been compromised as a result of cancer or other medical conditions, so they were excluded from this study.

Based on the clinically confirmed cases, researchers found the risk of the recurrence of shingles after a recent episode is fairly low, regardless of vaccination status. Each year, on average, 19 persons per 10,000 in the vaccinated cohort experienced a recurrence of shingles. The rate was only slightly higher for the unvaccinated population, at approximately 24 persons per 10,000 per year.

This is the latest in a series of published Kaiser Permanente studies conducted to better understand vaccine effectiveness and safety. In 2011, Dr. Tseng was a lead researcher in a Vaccine Safety Datalink study published in the Journal of Internal Medicine that found the herpes zoster vaccine to be safe. Also last year, Dr. Tseng published a study in the journalVaccine that found that administering the pneumococcal and the herpes zoster vaccines at the same time is as beneficial as if they were administered separately. In addition to that study, Dr. Tseng published a study in 2011 in the Journal of the American Medical Association that found the shingles vaccine is associated with a fifty-five percent reduced risk of developing the disease. In 2010, another study by Dr. Tseng in JAMA found the pneumococcal pneumonia vaccination is not associated with a reduced risk of heart attacks or strokes in men.

Two Kaiser Permanente studies found that the combination vaccine for measles, mumps, rubella and chickenpox is associated with double the risk of febrile seizures for 1- to 2-year-old children, compared to same-day administration of the separate vaccine for MMR (measles, mumps, rubella) and the varicella vaccine for chickenpox. Other Kaiser Permanente studies found that children of parents who refuse vaccines are nine times more likely to get chickenpox and 23 times more likely to get pertussis (commonly known as whooping cough), compared to fully immunized children. Another study found that herpes zoster is very rare among children who have been vaccinated against chickenpox.

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The recent brouhaha over pink slime (and other lovely mass meat production processes) is only the beginning. Here’s our roundup of some standout reporting about the food on your plate.

This is a multifaceted, perennial topic. If you think Propublica missed any, we’re happy to hear suggestions. Please email a link to MuckReads@propublica.org or tweet it with the hashtag #muckreads.

Safety of Beef Processing Method Is Questioned, The New York Times, December 2009
A look at the development of Beef Product Inc.’s “novel” method of meat production that later became known as the infamous “pink slime.” Reporter Michael Moss won a Pulitzer Prize for his investigations into contaminated beef.

Our Dwindling Food Variety, National Geographic, July 2011
Our dwindling food variety, in a stride-stopping infographic.
Contributed by @kleinmatic

What the USDA Doesn’t Want You to Know About Antibiotics and Factory Farms, Mother Jones, July 2011
The U.S. Department of Agriculture appears to have repeatedly removed a report by a USDA-contracted researcher that summarized recent academic work, from “reputed, scientific, peer-reviewed, and scholarly journals,” on possible links between antibiotic-resistant infections and factory farm animals. Mother Jones got a permanent PDF of the researcher’s report, dubbing it the “document the USDA doesn’t want you to see.”
Contributed by @foodinteg

Asian Honey, Banned in Europe, Is Flooding U.S. Grocery Shelves, Food Safety News, August 2011

Some of the biggest U.S. honey packers knowingly bought honey of questionable quality so they could sell it on the cheap. Much of it was likely smuggled from China (honey the European Union has banned) and may have been laced with lead and illegal animal antibiotics — if it was really honey at all.

America’s Dangerous Food-Safety System, The Daily Beast/ Newsweek, September 2011
A shortage of inspectors in the U.S. food-safety system exposes Americans to the risk of illness and death.
Contributed by @StepShep

Nation’s Food Anti-terror Plans Costly, Unwieldy, Associated Press, September 2011 
An AP investigation into the United States’ $3.4 billion food counter-terrorism program found that progress had been slowed by a complex web of bureaucracy.
Contributed by @joannalin

On The Menu, But Not On Your Plate, Boston Globe, October 2011
A Globe-organized DNA test revealed scores of mislabeled fish in Massachusetts restaurants, grocery stores and seafood markets. Often, “local” fish was actually hauled from thousands of miles away, and while some chefs and store owners seemed to have no clue, others admitted to knowingly selling mislabeled food to boost profits. Experts said it reflects a nationwide trend that causes diners to unwittingly overpay, may make people sick and results in overfishing.

Contributed by @JoeYerardi

Dispute Over Drug in Feed Limiting U.S. Meat Exports, MSNBC, January 2012
The controversial drug ractopamine has sickened or killed more pigs than any other livestock drug on the market, leading the EU and China, which together produce and consume about 70 percent of the world’s pork, to refuse meat imports raised on the additive. The U.S. pork industry wants to change their minds.
Contributed by @NaomiStarkman

How Washington Went Soft on Child Obesity, Reuters, April 2012
The food and beverage industries have more than doubled their spending on lobbying in Washington in the last three years. And now Congress has declared pizza a vegetable.
Contributed by @mariancw

A History of FDA Inaction on Animal Antibiotics, ProPublica, April 2012
Everything you ever wanted to know about the Food and Drug Administration’s actions, or lack thereof, to keep antibiotics out of your food.

As Beef Cattle Become Behemoths, Who Are Animal Scientists Serving? The Chronicle of Higher Education, April 2012
A growing number of animal scientists employed by public universities are accepting payouts from pharmaceutical companies. They’re often hired to persuade farmers to use antibiotics that fatten up cattle but haven’t necessarily been proven safe. Some have been banned in the E.U. and China.
Contributed by @MelodyPetersen

Bonus points: In 1968, Nathan Kotz of the Des Moines Register and Minneapolis Tribune won a Pulitzer Prize for reporting on unsanitary conditions in meat packing plants, which, according to the Pulitzer site, helped ensure passage of the Federal Wholesome Meat Act of 1967. Anybody have an online copy?

by Blair Hickman, ProPublica, May 7, 2012, 12:21 p.m.

The article The Best, Most Disgusting Reporting on Food Safety appeared first on The Toonari Post - News, Powered by the People!.

Pink Slime, also called lean finely textured beef (LFTB) or boneless lean beef trimmings (BLBT), has been around for a long time before the public heard about it.

The term was coined in 2002 by Gerald Zirnstein, a former USDA scientist, in an internal email. In 2009, when the New York Times published an article about the fast food industry, and later in an article in the newspaper, the name was released and the controversy started. Consumers are asking questions about how food is being made, what they are eating, and what exactly is on the food labels.

The key debate is the use of ammonia in processing foods. LFTB is made from the leftover meat trimmings that would otherwise be discarded, separated from the fat with a centrifuge and sprayed with ammonium hydroxide to kill bacteria. Because this is a part of the process, not part of the final product, the use of ammonia hydroxide does not need to be printed on the labels.

In fact, the Food and Drug Administration (FDA) determined in 1974 that ammonia in foods was not harmful. It is on their list of foods “Generally Recognized as Safe,” defined as not problematic for human consumption in the amounts they are currently used in. Most consumers associate ammonia with the cleaning product.

Beef Products, Inc. has received so much criticism for ammonium hydroxide that three out of four of their processing plants closed. The lesser demand shows that consumers are worried about their food, but big business does not agree. The company received the Black Pearl Award in 2007 for, among other things, advancing food safety.

In 2004, the company was honored the Food Quality Award, which recognizes product safety in relation to a positive impact on business results. Beef Products, Inc also published a list of foods that contain ammonia on their website. The compound turns up naturally in some dairy products, such as milk. It is used in cheeses to take away some acidity, found in baked goods, gelatins, chocolate, caramels, and puddings.

Other companies are being called forward as well, such as the Hershey chocolate company, Kellogg, and ConAgra, producer of Wonder Bread and Chef Boyardee. Kraft Foods admits to using ammonia compounds in some of their products, though the company will not say which ones.

Pink slime has some benefits. The beef industry employs thousands of workers. LFTB may actually be safer than regular ground beef because of the way it is treated, which removes bacteria, as opposed to untreated beef, which has caused outbreaks of mad cow disease, e. coli and salmonella. Pink slime makes beef cheaper, available to all families struggling with income, and leaner, containing less fat.

Many experts agree that without the name “pink slime,” the scare would not be so huge. Yet, the fact is, worse practices are being conducted in the beef and poultry industries that consumers don’t know about. The pink slime debate is just the tip of the iceberg.

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Indianapolis, U.S.A. – Eli Lilly and Company applauded law enforcement officials for their successful investigation and the recovery of more than $70 million in pharmaceuticals stolen from its United States distribution center located in Enfield, Connecticut, on Sunday, March 14, 2010.

“For more than two years, Lilly has cooperated with this criminal investigation – providing important information to federal and local authorities to help piece together the details of the theft,” said Maria Crowe, President, Manufacturing Operations, Eli Lilly and Company.

“We applaud the dedication of the Enfield Police Department, the Federal Bureau of Investigation, Department of Justice prosecutors in New
Haven, Newark, and Miami, and the Miami Organized Crime Drug Enforcement Task Force,  who have worked tirelessly to identify and apprehend those suspected of being involved in the March 2010 burglary,” said Crowe.

The pharmaceuticals taken from Lilly’s warehouse have been successfully recovered, preventing them from entering pharmaceutical distribution channels. Lilly plans to destroy the products when they are no longer needed as evidence.

Crowe added that Lilly is committed to partnering with the Food and Drug Administration, law enforcement, and other officials and organizations to help ensure patient safety and the secure distribution of Lilly medicines.

To that end, in addition to strengthening security for its facilities and pharmaceutical transportation, Lilly is one of seven pharmaceutical companies that formed the Coalition for Patient Safety and Medicine Integrity in 2011. Two primary goals of the coalition are to protect patients from risks posed by stolen and inappropriately handled medical products that enter legitimate distribution channels and increase the associated federal criminal penalties for crimes involving stolen medical products.

Image Courtesy of    http://www.lilly.com

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Each prescription drug you take has a unique code that the government can use to track problems. But artificial hips and pacemakers? They are implanted without identification, along with many other medical devices. In fact, the FDA doesn’t know how many devices are implanted into patients each year – it simply doesn’t track that data.

The past decade has seen numerous high profile cases of malfunctioning medical devices, which have led to injury or even death. Critics say the FDA’s minimal monitoring of devices contributes to these problems.

“If you’re lucky, you might find a sticker on the operating room note that was left over from the product,” said Richard Platt, who runs the Harvard Pilgrim Health Care Institute. Otherwise, there is little way of knowing what device was used.

Right now, the FDA depends mostly on voluntary reports from doctors, patients, manufacturers and hospitals to notify them of problems with devices already on the market. The agency does have some power to require manufacturers to conduct further studies or track a particular device once it is sold. But many devices don’t get that level of surveillance.

“It’s much like a patchwork of streams of information getting to the FDA,” said cardiologist Frederic Resnic of Brigham and Women’s Hospital, who has worked with the FDA on medical device safety monitoring. “The FDA is relying on anecdotal and very variable information about the safety of medical devices.”

If manufacturers get word from a doctor or hospital about a death or injury that occurred as a result of their product, they are legally obligated to investigate the event and report it to the FDA. But the process isn’t straightforward, as has become clear in the recent controversy over the malfunctioning St. Jude’s Riata defibrillator leads (wires that connect a defibrillator to the heart). The FDA said an individual doctor’s report helped alert them to the problem, but it was months before the device was recalled.

According to attorney William Vodra, a regulatory law expert and member of the Institute of Medicine panel that published a report on medical device safety last year, the number of doctors who actually contact manufacturers is small.

And after being notified of patient harm, manufacturers can minimize their own responsibility if they point the blame elsewhere, said health policy expert Diana Zuckerman, president of the National Research Center for Women & Families.

For example, if someone dies from complications in a surgery to remove an implant, the manufacturer may argue that it was the surgery – not the implant – that killed the patient.

“You have a system that is not rigorous, the standards are not always understood, and they are interpreted differently by different people,” Zuckerman said.

The FDA responds to the criticism by pointing out that while every medical device carries a potential risk, the vast majority of devices perform well and improve patient health. An FDA spokeswoman emphasized that the agency must evaluate thousands of medical devices each year, and is constantly looking for ways to better and more quickly identify problems.

While the FDA makes the adverse event reports publically available in a searchable database, it doesn’t have a standardized system for reviewing reports once they are sent in, said Vodra, the attorney. A disclaimer on the site specifically states that the data is “not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices.”

“What you would normally consider the simplest kind of data analysis is not done,” said Zuckerman. Often, doctors catch a malfunctioning device before the FDA ever notices.

In one case, a group of Pennsylvania doctors noticed that several patients were showing severe complications a few years after getting an IVC filter – a device designed to capture blood clots. Bits of the filter were breaking off, causing chest pain and a dangerous build-up of fluid and pressure around the heart. In 2010 the doctors conducted their own studyand found that the filter broke in a quarter of all patients who used it.

On the day that study was published, the FDA issued a warning saying it had received over 900 reports of problems with IVC filters since 2006, and that the device was meant to be removed after a few months, not left in permanently.

There have been numerous attempts at reform. Five years ago Congress ordered the FDA to set up a post-market surveillance system to track the safety of all medical projects, but a system hasn’t yet been set up for medical devices.

A year later the FDA announced the Sentinel Initiative, which would combine existing data from electronic health records and medical claims to track drugs, vaccines, and devices. Some groups of hospitals or other organizations have voluntarily set up registries to collect information about the make and model of devices.

While the FDA has made significant progress on tracking drugs, it’s not yet in a position to do the same thing for devices, according to Harvard’s Platt, who is the principal investigator of Mini-Sentinel, the FDA’s pilot program for the national system. The data isn’t there.

The FDA has long acknowledged the need for a unique device identifier system, and got permission from Congress to set one up five years ago. No such system of ID-tags exists yet, but after several recent high profile medical device failures, the issue getting some attention from Congress. A proposed Senate bill, which cleared the Health, Education, Labor and Pensions Committee last week, sets a timeframe for implementing a unique identification system, among other reforms.

“If UDI’s were used in a consistent way, we could use the same kinds of techniques we’ve developed for drugs for devices,” said Platt. “It would be a huge breakthrough.”

by Lena Groeger, ProPublica, May 3, 2012, 1:07 p.m.

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St. Louis, U.S.A. – Throughout grocery store aisles, shoppers find many soy-based choices to complete a nutritious diet. In April, Soyfoods Month, U.S. soybean farmers want to highlight the benefits of soy products and their availability in products that may not come to mind.

Jim Stillman, a soybean farmer from Emmetsburg, Iowa, and current vice chair for the United Soybean Board and soy checkoff, says he uses soy in his kitchen.

“Baking cookies or brownies, I use soy flour and soy oil,” says Stillman. “It’s just a matter of what you get used to, and I use soymilk in my cooking. I use everything I can that’s soy.”

Soy remains a popular choice for consumers looking for vegetable protein. But Stillman says you don’t have to replace meat in your diet to use soy. Soy can be used with meat instead of replacing it.

The Food and Drug Administration approved a claim that says 25 grams of soy protein a day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. Stillman notes soy products provide a variety of choices to reach that goal.

“You take 25 grams of protein a day from soy protein, and you can get that in many forms: through milk, flour or even tofu,” adds Stillman. “That small amount makes a healthier, more beneficial meal and adds protein to anything you cook.”

The 69 farmer-directors of USB oversee the investments of the soy checkoff to maximize profit opportunities for all U.S. soybean farmers. These volunteers invest and leverage checkoff funds to increase the value of U.S. soy meal and oil, to ensure U.S. soybean farmers and their customers have the freedom and infrastructure to operate, and to meet the needs of U.S. soy’s customers.

As stipulated in the federal Soybean Promotion, Research and Consumer Information Act, the USDA Agricultural Marketing Service has oversight responsibilities for USB and the soy checkoff.

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The Just Label It (JLI) Campaign announced that a record-breaking one million Americans of all political persuasions have called on the FDA to label genetically engineered (GE) foods. The campaign also announced a new national survey revealing that Americans across the political spectrum stand united in support of labeling food that has been genetically engineered. This is a striking contrast to the partisan divisions plaguing our political system.

“Pink slime, deadly melons, tainted turkeys, and BPA in our soup have put us all on notice that what we eat and feed our families is critically important,” said Ken Cook, President of the Environmental Working Group. “Americans overwhelmingly demand safety, transparency and labeling of genetically engineered foods. It’s time for the FDA to come clean and restore public confidence in our food system.”

Since October, JLI, the national campaign to require GE-food labeling and its more than 500 partner organizations have spearheaded an historic number of public comments for a GE-foods labeling petition. March 27, 2012 is the date when the FDA was required to respond to the petition. It took less than 180 days to accumulate the record number of comments.

“In recent years, Americans have shown a real interest in knowing more about our food and now there is a clear mandate for the labeling of genetically engineered foods. This petition asks the FDA to stand up for the rights of average Americans, and not just a handful of powerful chemical companies.

It’s time for the FDA to give Americans the same rights held by citizens in forty nations, including all of our major trade partners, to know whether our foods have been genetically modified. The FDA needs to restore confidence in our food and our right to know about the food we eat and feed our families,” said Gary Hirshberg, chairman of Stonyfield.

New Survey Results: Motherhood, Apple Pie and GE Food Labeling Consumer support for GE-foods labeling in the U.S. is nearly unanimous, according to the political opinion survey on GE food labeling conducted by The Mellman Group on behalf of JLI.

“Few topics other than motherhood and apple pie can muster over 90%support, but labeling GE-foods is one of those few views held almost unanimously,” explained pollster Mark Mellman. The survey found nearly all Democrats (93% favor, 2% oppose), Independents (90% favor, 5% oppose) and Republicans (89% favor, 5% oppose) in favor of labeling. The study also revealed that support for labeling is robust and arguments against it have little sway.

Colorado mother and author Robyn O’Brien, who founded the AllergyKids Foundation after one of her children had an allergic reaction to breakfast, said: “Americans are responding to the call for GE foods labeling because they want more information for their families.

Like allergen labeling, GE-food labels would provide essential and possibly life-saving information for anyone with a food allergy. Being responsible for the health and safety of my children, I believe it’s my right to know about the food I feed my family…from allergens, to ‘pink slime’ to GE foods.”

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March is National Nutrition Month, bringing healthful eating and positive nutritional choices to the forefront for Americans. With nutrition top-of-mind, the U.S. Food and Drug Administration reminds you about a simple tool to help you make informed food decisions!  It’s called the Nutrition Facts Label, and you can find it on all packaged foods and beverages.

The Nutrition Facts Label lets you know exactly what you’re eating and serves as your guide for comparing foods and making choices that can affect your long-term health.

Start Today…And Use It Forever!

You’re likely hearing a lot about nutrition during the month of March. But while the Nutrition Facts Label is a tool you can start using right now … the best news is that you can continue to use it every time you shop for food. The Nutrition Facts Label serves as your guide in several ways.  And once you get started, you’ll see how easy “label reading” really is.

The Nutrition Facts Label shows the calories per serving. Keep in mind that 100 calories in a serving of food is moderate, and 400 calories is high.  The label also lists the number of servings per container.  It’s quite common for a package of food to contain more than one serving – so that means that if you eat two servings (or more) of that food, you are getting two (or more) times the number of calories and nutrients that are listed on the label.

The Nutrition Facts Label is also your tool to track nutrients. The Percent Daily Value (shown as %DV) gives you a framework for deciding if a food is high or low in a particular nutrient.

This is helpful for nutrients you are trying to get more of (such as calcium and Vitamins A and C), as well as for the ones you are trying to get less of (like sodium, total fat and cholesterol).  The %DV recommendations are based on a 2,000-calorie daily diet, and each listed nutrient is based on 100% of the recommended amounts for that nutrient. There is an easy rule of thumb to follow when comparing nutrients: 5% DV or less of a particular nutrient means the food is low in that nutrient, and 20% DV or more means it’s high!

Start using the Nutrition Facts Label today and you’ll be in the know about the foods you are choosing. Identify serving size, check calories per serving, and monitor nutrients – especially the ones you are trying to get less of, like sodium, total fat and cholesterol. That’s how you can compare foods and make the nutritional choices that are best for you and your family.

For more information about the Nutrition Facts Label and to obtain materials visit:
http://www.fda.gov/Food/ResourcesForYou/Consumers/ucm266853.htm
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm094536.htm
http://www.fda.gov/nutritioneducation

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Are statin drugs leading to more problems than just diabetes and memory loss as the FDA says?

Following on the heels of the FDA announcing changes to the safety information on statin labels (e.g. Pfizer Inc’s Lipitor, AstraZeneca’s Crestor and Merck & Co’s Zocor) concerning blood sugar and memory problems, a collection of consumer health groups, such as Natural Society, are raising public awareness about the hundreds of additional adverse health effects associated with their use as indicated by the published research from the National Library of Medicine.

A growing body of clinical research now indicates that this cholesterol-lowering class of drugs is associated with an alarming number of serious medical conditions – research boldly flying in the face of national health policy, medical insurance premium guidelines, statin drug manufacturer advertising claims, and the general sentiment of the public, with approximately 1 in every 4 adult Americans over 45 currently using these drugs to “prevent heart disease.”

Fundamentally, the research indicates that statin drugs damage the muscles and nerves in the body. There are well over 100 studies demonstrating the myotoxic, or muscle-harming effects of these drugs, and over 80 demonstrating the nerve-damaging effects.

Since the heart is such a vital muscle innervated by a complex network of nerves, many healthcare providers now seriously question whether the unintended, unwanted side effects of statins are worse than the purported “cardiovascular” benefits they provide. Therefore, these peer reviewed research studies may also explain why rates of heart failure may be increasing in the general population who are given these drugs.

While the discovery that statin drugs, instead of preventing heart disease likely contributes to it, might be surprising; it should not distract from the more disturbing discovery that they contribute to over 300 disease and/or adverse health effects. Fortunately research has found that many of the statin-linked diseases, like diabetes, can be combated with natural substances like vitamin D.

In light of these findings many health professionals are now asking: Are those who are party to the manufacture, promotion, administration and/or prescribing of this chemical class of drugs, in violation of the medical ethical principle of informed consent?

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Amylin Pharmaceuticals recently announced that it is participating in the fifth annual international Rare Disease Day to demonstrate the Company’s support for patients and families who are impacted by rare diseases. Celebrated around the world today, Rare Disease Day aims to raise awareness of the more than 7,000 known rare diseases and the effects of these diseases on patients’ lives, and to provide a platform of unity for rare disease patient communities.

In the U.S., a disease is considered rare, or orphan, if it affects fewer than 200,000 individuals. According to the National Institutes of Health Office of Rare Diseases Research, an estimated 25 to 30 million people in the U.S. have a rare disease. Most rare diseases have limited or no associated treatment options – and, to date, there are no known cures for these diseases.

“We are honored to participate in activities to draw heightened attention to rare diseases and the critical need to drive research to better understand these diseases and develop effective therapies for patients,” said Daniel M. Bradbury, president and chief executive officer of Amylin Pharmaceuticals.

“At Amylin, we are proud to be advancing the development of a potential therapy for rare forms of lipodystrophy, an ‘ultra-orphan’ disease. We believe all patients – whether they are impacted by one of the world’s most prevalent diseases, like type 2 diabetes, or one of the rarest – deserve better treatment options.”

Amylin launches disease awareness website – mylipodystrophy.com
To coincide with Rare Disease Day, Amylin also announced today the launch of mylipodystrophy.com, a disease awareness website that is dedicated to rare forms of lipodystrophy, and serves as a resource for information about the disease for patients, caregivers and healthcare providers.

People with lipodystrophy lack fat tissue. This can be partial, affecting select areas of the body, or generalized, affecting the entire body. The physical appearance of people with lipodystrophy can therefore vary considerably. Fat tissue is a major endocrine organ producing important metabolic hormones such as leptin.

A lack of functioning fat tissue can lead to relative deficiency of leptin. Without adequate leptin function, the metabolic system, which regulates food intake, energy storage, and energy production, falls out of balance. Fat accumulates in the blood or organs, which can lead to life-threatening complications including insulin-resistant diabetes, hypertriglyceridemia, acute pancreatitis and hepatic steatosis or steatohepatitis, also known as fatty liver disease.

There are no approved drugs to adequately treat the metabolic abnormalities that occur in lipodystrophy. To help raise public awareness of rare diseases, Amylin is also featuring a Rare Disease Day series on its corporate blog, Building Blocks, available at www.amylinbuildingblocks.com.

This series includes contributions from several experts in the rare disease field describing efforts underway to understand and combat rare diseases, as well as initiatives that are providing support for patient communities. Amylin is also participating in the Global Genes Project’s ”Wear that you Care” denim campaign, encouraging its employees to wear jeans to work today to show support for the rare disease cause.

Amylin is developing metreleptin as a potential treatment option for diabetes and/or hypertriglyceridemia in pediatric and adult patients with rare forms of lipodystrophy. The Company plans to complete the rolling Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) in the first half of this year.

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Cord Blood Registry (CBR) is the exclusive partner for a growing number of clinical researchers focusing on the use of a child’s own cord blood stem cells to help treat pediatric brain injury and acquired hearing loss.

To ensure consistency in cord blood stem cell processing, storage and release for infusion, three separate trials have included CBR in their FDA-authorized protocol—including two at the University of Texas Health Science Center at Houston (UTHealth) working in partnership with Children’s Memorial Hermann Hospital, and a third at Georgia Health Sciences University, home of the Medical College of Georgia (MCG). This makes CBR the only family stem cell bank pairing researchers with prospective patients for these studies.

“Partnering with a series of specialists who want to research the use of a child’s own newborn blood stem cells on a variety of disease states allows CBR to help advance medical research for regenerative therapies by connecting the child whose family banked with CBR to appropriate researchers,” said Heather Brown, MS, CGC, Vice President of Scientific & Medical Affairs at Cord Blood Registry.

“The pediatric specialists from UTHealth, Children’s Memorial Hermann Hospital, and Georgia Health Sciences University are at the forefront of stem cell research as they evaluate cord blood stem cells’ ability to help facilitate the healing process after damage to nerves and tissue.”

Hearing Loss and Traumatic Brain Injury Clinical Trials Break New Ground Sensorineural hearing loss affects approximately 6 per 1,000 children by 18 years of age, with 9 percent resulting from acquired causes such as viral infection and head injury. The Principal Investigator of the hearing loss study is Samer Fakhri, M.D., surgeon at Memorial Hermann-Texas Medical Center and associate professor and program director in the Department of Otorhinolaryngology – Head & Neck Surgery at UTHealth.

He is joined by James Baumgartner, M.D., sponsor of the study and guest research collaborator for this first-of-its-kind FDA-regulated, Phase 1 safety study of the use of cord blood stem cells to treat children with acquired hearing loss. The trial follows evidence from published studies in animals that cord blood treatment can repair damaged organs in the inner ear. Clients of CBR who have sustained a post-birth hearing loss and are 6 weeks to 2 years old may be eligible for the year-long study.

“The window of opportunity to foster normal language development is limited,” said James Baumgartner, M.D.  ”This is the first study of its kind with the potential to actually restore hearing in children and allow for more normal speech and language development.”

Although the neurologic outcome for nearly all types of brain injury (with the exception of abuse) is better for children than adults, trauma is the leading cause of death in children, and the majority of the deaths are attributed to head injury.Distinguished professor of pediatric surgery and pediatrics at UTHealth, Charles S. Cox, M.D. launched an innovative study building on a growing portfolio of research using stem cell-based therapies for neurological damage.

The study will enroll 10 children ages 18 months to 17 years who have umbilical cord blood banked with CBR and have suffered a traumatic brain injury (TBI) and are enrolled in the study within 6-18 months of sustaining the injury. Read more about the trial here.

“The reason we have become interested in cord blood cells is because of the possibility of autologous therapy, meaning using your own cells. And the preclinical models have demonstrated some really fascinating neurological preservation effects to really support these Phase 1 trials,” says Charles S. Cox, M.D., principle investigator of the trial.

“There’s anecdotal experience in other types of neurological injuries that reassures us in terms of the safety of the approach and there are some anecdotal hints at it being beneficial in certain types of brain injury.”

Georgia Health Sciences University (GHSU) Focuses on Cerebral Palsy

At the GHSU in Augusta, Dr. James Carroll, professor and chief of pediatric neurology, embarked on the first FDA-regulated clinical trial to determine whether an infusion of stem cells from a child’s own umbilical cord blood can improve the quality of life for children with cerebral palsy. The study will include 40 children whose parents have stored their cord blood at CBR and meet inclusion criteria.

“Using a child’s own stem cells as a possible treatment is the safest form of stem cell transplantation because it carries virtually no threat of immune system rejection,” said Dr. Carroll. “Our focus on cerebral palsy breaks new ground in advancing therapies to change the course of these kinds of brain injury—a condition for which there is currently no cure.”

Cerebral palsy, caused by a brain injury or lack of oxygen in the brain before birth or during the first few years of life, can impair movement, learning, hearing, vision and cognitive skills. Two to three children in 1,000 are affected by it, according to the Centers for Disease Control.

Cord Blood Stem Cell Infusions Move From the Lab to the Clinic

These multi-year studies are a first step to move promising pre-clinical or animal research of cord blood stem cells into clinical trials in patients. Through the CBR Center for Regenerative Medicine, CBR will continue to partner with physicians who are interested in advancing cellular therapies in regenerative applications.

“The benefits of cord blood stem cells being very young, easy to obtain, unspecialized cells which have had limited exposure to environmental toxins or infectious diseases and easy to store for long terms without any loss of function, make them an attractive source for cellular therapy researchers today,” adds Brown.

“We are encouraged to see interest from such diverse researchers from neurosurgeons to endocrinologists and cardiac specialists.”

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As the world’s largest professional society concerned with the causes and treatment of blood disorders, many of our more than 16,000 members are on the front lines of dealing with the country’s severe shortage of methotrexate, a drug critical in the treatment of children with acute lymphocytic leukemia (ALL).

The Food and Drug Administration (FDA) reported that two manufacturers plan additional releases within the week of February 20th, at the end of February, and continuing into March, which it anticipates will meet all patient needs.

While the Society is pleased with this announcement, we realize the shortage is still critical at many sites throughout the country and urge the FDA to ensure that once supplies are available, hematologists can have information on how to access this therapy for their critically ill patients.

ASH has been working hard to address the shortage, including reporting shortages to the FDA and Congress and urging the FDA to take immediate action to identify other manufacturers to meet demand, import supplies from overseas, and establish an emergency supply once there is a release so that supplies can be easily accessed.

Over the past year the Society has led collaborative efforts with the FDA, Congress, and senior health officials in the Administration to resolve not only this shortage, but also shortages of more than 200 other drugs, many of which are used to treat patients with hematologic diseases, that have become critical and life-threatening.

This week the Society sent a letter of support to Representatives Larry Buscon (D-IN) and John Carney (D-DE) who introduced bipartisan legislation (H.R. 3839, the Drug Shortage Prevention Act) that would provide expedite FDA review of drugs in shortage, improve communication within the agency and with stakeholders about possible shortages, and increase Drug Enforcement Administration (DEA) quotas for medications in short supply.

The Society is also submitting comments this week to the FDA concerning its Interim Final Rule, issued in response to the President’s Executive Order of Oct. 31, 2011, to enable the FDA to improve its collection and distribution of drug shortage information.

The steps the Society has taken over the past year have had impact. Following the introduction of bills in the House and Senate last year (S. 296/H.R.2245, the Preserving Access to Life-Saving Medications Act) mandating early notification by manufacturers of drugs in short supply, ASH was the first medical society to call on Congress to conduct hearings and has made recommendations on ways to prevent and mitigate drug shortages that are being incorporated into legislative and regulatory proposals.

ASH will continue to monitor all hematologic drug shortages closely and will continue to work with policy makers to protect the health of Americans.

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The U.S. Senate urgently needs to support legislation that would apply longstanding federal law on conscience protection to the Patient Protection and Affordable Care Act (PPACA), said the chairman of the Committee on Pro-Life Activities of the U.S. Conference of Catholic Bishops (USCCB).

In a February 15 letter to all Senators, Cardinal Daniel DiNardo of Galveston-Houston explained how the “Respect for Rights of Conscience Act” (S. 1476) is especially needed since a new mandate by the Department of Health and Human Services (HHS) will force almost all health insurance plans to cover all FDA-approved contraceptives, including drugs that can cause an early abortion, and sterilizations. Even many religious organizations will not be exempt from the mandate.

This rule, Cardinal DiNardo noted, was finalized on February 10. On the same day the White House announced it would develop a mechanism for applying the rule to non-exempt religious employers, claiming it would shift costs for contraceptive coverage to insurers.

“It is little or no comfort that, rather than being forced to propose such coverage, religious organizations will simply have it imposed on them,” Cardinal DiNardo said. “The argument that they will not really have to subsidize the coverage, because insurers will offer it ‘free of charge,’ runs up against the reality that this coverage will be integrated into their overall health plan, and subsidized with the premiums paid by employer and employee for that plan.”

He added: “The Administration’s rule makes no provision for the rights of insurers, even religiously affiliated insurers, but places responsibility for enforcing the mandate more squarely than ever on their shoulders. This is a radical departure from current law, under which a health plan that excludes contraception can be sold even to federal employees if the carrier has any religious objection to such coverage.”

Cardinal DiNardo outlined the scope of the proposed Senate bill, noting that it does not support discriminatory decisions to withhold basic coverage, does not free anyone from responsibilities under other state or federal laws, and does not allow anyone to deny coverage for high-cost treatments using morality and religion as a pretext.

Cardinal DiNardo explained what the bill does achieve: “It states that the new lists of mandated benefits for private health plans created under PPACA will not forbid those who provide, sponsor and purchase health coverage to negotiate a health plan that is consistent with the religious beliefs and moral convictions of those involved.”  Thus, he said, “it simply ensures that new requirements under PPACA are not used to take away a freedom of conscience that Americans have enjoyed under federal law until now.”

“If the needless dispute over this issue were resolved through this legislation, Congress and the Administration could return to the most pressing of all the real problems – the fact that many millions of Americans still lack basic coverage for health care that supports and sustains life,” Cardinal DiNardo said. “Let us begin the task by respecting each other’s values that call so many of us to work for life-affirming health care for all in the first place.”

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Few hospitals have as much experience with the Berlin Heart as DMC Children’s Hospital of Michigan. This is why the U.S. Food and Drug Administration (FDA) was eager to hear testimony from Henry L. Walters III, MD, chief of cardiovascular surgery at DMC Children’s Hospital of Michigan. Dr. Walters provided testimony about the device at a recent public hearing.

After reviewing the clinical trial data and hearing testimony from Dr. Walters and others, the device has now been approved. The Berlin Heart is the first ventricular assist device made specifically for pediatric patients. Ventricular assist devices are common in adults. But, until recently, they weren’t manufactured in pediatric sizes.

Ventricular assist devices are used when a patient needs a heart transplant, but can’t wait for a donor heart to become available. The Berlin Heart assists the failing heart until an appropriate donor heart can be found.

“A few times a year, we are faced with a situation where a child simply can’t wait for a heart transplant,” Dr. Walters said. “In these cases, the Berlin Heart works very well and the children generally stabilize and start to thrive and improve while they wait for a donor heart.”

Before the device was approved by the FDA, Dr. Walters and his colleagues used the Berlin Heart under the FDA’s “compassionate use” regulations. Since 2005, Dr. Walters and his colleagues have inserted 14 Berlin Hearts. Of the 14 patients, 10 survived to cardiac transplantation and nine of the patients are thriving today – a result directly attributable to the efficacy of the Berlin Heart. The nine survivors ranged in age from 6 months to 13 years.

Before availability of the Berlin Heart, Dr. Walters and his colleagues occasionally adapted an adult ventricular assist device for use in a child, but the results were not optimal and some patients were too small for a modified adult device.

“The Berlin Heart stands alone in filling a tremendous void in the field of pediatric cardiac failure. I can honestly say that of our nine survivors, eight were too small to have possibly accommodated any of the available adult ventricular assist devices. For these patients the Berlin Heart was truly the key to their survival,” adds Dr. Walters.

The pediatric heart transplant program at the DMC Children’s Hospital of Michigan is the largest in the state of Michigan and one of the largest in the Midwest. For 125 years the DMC Children’s Hospital of Michigan is the first and most experienced hospital in the state dedicated exclusively to the treatment of children.

A leader internationally in neurology and neurosurgery, cardiology, oncology, and diagnostic services, it is ranked one of America’s best hospitals for children. More Michigan pediatricians are trained at the Children’s Hospital of Michigan than in any other facility.

Children’s Hospital of Michigan is one of eight hospitals operated by the Detroit Medical Center (DMC). The DMC is proud to be the Official Healthcare Services Provider of the Detroit Tigers, Detroit Red Wings and Detroit Pistons.

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Have you dyed or relaxed your hair? Do you put on lipstick before you head out to work? Do you paint your nails? Many women have a beauty routine or beauty products that they regularly use. Have you ever worried that yours might increase your risk for cancer? Before you panic and cancel your appointment at the salon, read on—it’s time to break down some beauty-related cancer fact and fiction.

Hair Dye: It is estimated that more than one-third of women over age 18 and about 10 percent of men over age 40 use some type of hair dye.  Hair dyes are full of chemicals—5,000, to be precise—and that hasn’t escaped the notice of cancer researchers. Decades ago, researchers began studying chemicals used in hair dye.

They found that early dye formulations contained chemicals that could cause cancer in animals. Not surprisingly, manufacturers changed the formulas and eliminated some of these chemicals in the United States around 1980. Because so many people use hair dyes, researchers continue to monitor whether chemicals in hair coloring products can increase risk for cancer in humans.

According to the National Cancer Institute (NCI), the evidence for increased risks for cancer from modern hair dyes use is limited and inconsistent. Some studies have indicated that people who used hair dyes had an increased risk for bladder and breast cancer, as well as cancers of the blood and bone marrow (such as non-Hodgkin lymphoma and leukemia), while other studies have not.

Based on its review of the evidence, the Working Group of the International Agency for Research on Cancer (IARC) concluded that personal use of hair dyes is “not classifiable” as cancer-causing to humans. So it is still unclear if personal use of hair dyes can increase your risk for cancer.

If you would like to learn more about hair dye and health risks, the Outreach and Information Center of the U.S. Food and Drug Administration’s Center for Food Safety and Applied Nutrition has information about hair dyes and how they are regulated.

Hair Straightening: If you or your stylist uses hair smoothing or straightening products keep in mind that some of these products contain formaldehyde. Although formaldehyde is naturally occurring and is also used widely in many consumer products, this chemical is a known human carcinogen (cancer-causing substance) and can also cause skin irritation and sensitization. 

People can be exposed to formaldehyde in the workplace and in their home environment, but the highest levels are found in work settings where formaldehyde is produced or used. In a salon, formaldehyde levels are elevated when formaldehyde-containing products are being applied, but they quickly return to a lower level.

Remember that although your cancer risk from these hair products may be low, both hair dyes and straightening products contain chemicals that can hurt your skin, hair, and eyes especially if you are not careful or do not use them as intended.

Nail Products: When you head in for a manicure and you see the manicurist wearing a dust mask, you may have wondered about your own safety too. Nail salon workers wear dust masks to minimize breathing in dust particles when filing or shaping artificial nail enhancements.  Dust masks are intended to prevent inhalation of dust, but they do not protect against inhalation of chemicals.

Professional nail care products are typically formulated to minimize exposure to hazardous chemicals that may cause adverse health effects.  However, overexposure may occur and could result in skin irritation, allergic reaction, or serious eye injury. If you work at a nail salon, own a salon, or just want to learn more, check out the publication Protecting the Health of Nail Salon Workers by the U.S. Environmental Protection Agency.

The publication helps workers understand product ingredients and how to prevent overexposure to those that present potential health risks. As with any cosmetic product that may be hazardous if misused, you should read labels of nail products carefully and heed any warnings. But as far as cancer is concerned, there is no known risk associated with using nail products.

Lipstick: Some of the natural colors used in lipstick contain trace amounts of lead.  The National Toxicology Program (NTP) of the National Institute of Environmental Health Sciences of the National Institutes of Health says that lead and lead products are “reasonably anticipated to be human carcinogens.”

However, the Food and Drug Administration (FDA) has assessed the potential for harm to consumers from use of lipstick containing lead and determined that there is no safety concern because lipstick is intended for topical use and is only ingested incidentally and in small quantities. Always use your lipstick only as directed and keep the products away from children.

With all the news coverage out there claiming this product or that product may cause cancer, it sometimes may be hard to figure out what’s safe, what’s hazardous, and what’s plain, old sensationalized.

One way to minimize the damage and fear caused by misinformation is to identify respected sources—such as the National Cancer Institute (www.cancer.gov) or Food and Drug Administration—and use them as primary resources for your health information.   Knowing the facts is one way to keep your beauty routine good-looking inside and out.

The article Beauty Products and Cancer appeared first on The Toonari Post - News, Powered by the People!.

The U.S Food and Drug Administration is warning dental and veterinary professionals to not purchase or use certain potentially unsafe hand-held dental X-ray units. The FDA is concerned that these devices may not be safe or effective and could expose the user and the patient to unnecessary and potentially harmful X-rays.

The units, sold online by manufacturers outside the United States and directly shipped to U.S. customers, have not been reviewed by the FDA and do not meet FDA radiation safety requirements. The Washington State Department of Health alerted the FDA after tests on a device purchased online revealed it did not comply with X-ray performance standards.

As a result, FDA is investigating the extent of the problem and notifying state regulatory authorities, dental professional organizations and other health organizations about the safety risks. To date, no adverse events have been reported.

A hand-held dental X-ray unit is a small, portable device that is intended for dental X-ray examinations. All units that have been cleared by the FDA bear a permanent certification label/tag, a warning label, and an identification (ID) label/tag on the unit.  Use of these devices requires a prescription from a licensed practitioner.

“Health care professionals using these devices should verify they are purchasing and using those that have been reviewed and tested to meet FDA’s standards,” said Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health.

To ensure this, users should:

• Verify the presence of required labels on the device.
• Ask vendors whether the device has been reviewed and cleared by the FDA.
• Access the FDA Medical Device Approvals and Clearances searchable database to verify that the X-ray unit has been cleared by the FDA.
• Contact their state regulatory agency if they become aware of a device that may be hazardous or does not meet the FDA’s requirements.

The FDA will continue to monitor this problem and keep the public informed as new information becomes available.

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A few weeks ago, the Food and Drug Administration hit the American Red Cross with a nearly $10 million fine for safety violations, lax oversight and faulty testing of its blood services. The fine is just the latest of more than a dozen the Red Cross has racked up in the last decade.

In 2003, a federal court, frustrated by repeated blood safety violations by the Red Cross, gave the FDA the power to fine the organization. Forty-six million dollars in penalties later, many of the same violations — understaffing, ineffective screening of donors, failure to recall infected blood — are outlined in the recent letter the FDA sent to the executive vice president of Biomedical Services for the Red Cross.

The 32-page letter describes hundreds of violations over several months in 2010 at 16 Red Cross facilities across the country, and details how the Red Cross repeatedly failed to properly track and record information about donors and blood units. (To see the actual document and others like it, go to our timeline of Red Cross fines.)

For example, the agency failed to notify health departments when donors had infectious diseases such as HIV and syphilis, failed to add new donors with infected blood to a national list of people who aren’t allowed to donate, and failed to review records of donors who had bad reactions, such as a 16-year-old who lost consciousness and fell to the floor after giving a unit of blood. It also failed to follow written procedures, such as the case of a phlebotomist in Arizona who stuck herself with a needle before sticking a donor with the same needle to draw blood. The case went unreported for a month, because a staff member “was not aware of the need to immediately notify a Medical Director,” according to the inspection letter.

In a recent statement, the Red Cross said it was disappointed that the FDA issued the fine for “an inspection conducted so long ago” and noted that it has “already taken corrective steps to address those matters and that improvements in operations have been made.”

In an email to ProPublica, a Red Cross spokeswoman also said there is no evidence that these violations endangered any patients, adding that the blood supply is safer than it has ever been. The spokeswoman said the agency has made significant improvements, including reducing the number of problems system-wide by at least 65 percent, and is investing in technology upgrades. For example, the agency recently upgraded software and computer equipment at blood drives to better collect and track donor information.

The FDA’s letter laying out the fines says the Red Cross “has known of these continuing problems and has failed to take adequate steps to correct them.” The FDA also noted that “many of the violations recounted in this letter are virtually identical to violations charged in previous [letters].” In June 2010 the FDA imposed a $16 million penalty on the Red Cross for the same type of violations.

The chronic problems raise the question of whether penalties are working at all.

The Red Cross has been making promises and failing to keep them for over a decade, according to Sidney Wolfe, who heads the health research group at the consumer watchdog organization Public Citizen. Wolfe said he wrote to head of the FDA in 2000, urging it to hold the Red Cross in contempt of court. A federal court first put the Red Cross under government supervision in 1993 after finding blood safety lapses. A decade later, in 2003, the court empowered the FDA to impose fines.

“But fast-forward nine years ahead, and we have the same violations,” Wolfe said.

If the Red Cross disagrees with an assessment, it can ask the FDA to reevaluate the penalty, but in most cases the fine only changes by a few thousand dollars.

Most of the recent problems inspectors cited have to do with managing records and tracking blood donors. The Red Cross says it is unaware of any infections or deaths that stemmed from problems noted in the report, and that “serious problems” account for only three percent of the total problems found.

The FDA doesn’t think that’s good enough.

“FDA cannot definitively say there was never any danger to the blood supply since the violations can create conditions that could lead to potential safety consequences,” said FDA spokeswoman Patricia El-Hinnawy.

The government requires that the Red Cross (like any blood services operation) have multiple safeguards for its blood services. That includes asking a donor questions to identify any risks, checking his or her name against a national list of people who aren’t allowed to give blood, testing for infectious diseases, keeping track of blood units so infected blood isn’t released, and investigating any deviations from standards.

Because blood transfusions always carry a degree of risk, the FDA considers every step in that process critical to minimizing problems. “Failure of an individual safeguard does not automatically translate into the release of unsafe products,” an FDA spokeswoman told ProPublica in an email, “however, it may increase the potential for risk.”

In 2008, the Red Cross consolidated its blood work to two facilities: one in Charlotte, N.C., and the other in Philadelphia. The offices are in charge of managing, tracking and, if need be, recalling blood. But according to the inspection letter, both offices have been chronically understaffed, and simply haven’t been able to carry out their required functions in a timely or effective manner. As of 2010, the offices had a backlog of about 18,000 donor management cases.

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by Lena Groeger ProPublica, Feb. 2, 2012, 8:27 a.m.by Lena Groeger, ProPublica, Feb. 1

Image Courtesy of  littleny / Shutterstock.com

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The U.S. Food and Drug Administration has approved Kalydeco (ivacaftor) for the treatment of a rare form of cystic fibrosis (CF) in patients ages 6 years and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator (CFTR) gene.

CF is a serious genetic disorder affecting the lungs and other organs that ultimately leads to an early death. It is caused by mutations (defects) in a gene that encodes for a protein called CFTR that regulates ion (such as chloride) and water transport in the body. The defect in chloride and water transport results in the formation of thick mucus that builds up in the lungs, digestive tract and other parts of the body leading to severe respiratory and digestive problems, as well as other complications such as infections and diabetes.

CF, which affects about 30,000 people in the United States, is the most common fatal genetic disease in the Caucasian population. About 4 percent of those with CF, or roughly 1,200 people, are believed to have the G551D mutation.

“Kalydeco is an excellent example of the promise of personalized medicine – targeted drugs that treat patients with a specific genetic makeup,” said FDA Commissioner Margaret A. Hamburg, M.D. “The unique and mutually beneficial partnership that led to the approval of Kalydeco serves as a great model for what companies and patient groups can achieve if they collaborate on drug development.”

The FDA reviewed and approved Kalydeco in approximately three months under the agency’s priority review program that is designed to expedite the review of drugs. The priority review program uses a six-month review, instead of the standard 10 months, for drugs that may offer significant advances in treatment over available therapy.

Kalydeco was approved ahead of the drug’s April 18, 2012, prescription user fee goal date and is designated as an orphan drug, which identifies the disease as affecting fewer than 200,000 people in the United States.

In patients with the G551D mutation, Kalydeco, a pill taken two times a day with fat-containing food, helps the protein made by the CFTR gene function better and as a result, improves lung function and other aspects of CF such as increasing weight gain.

“Kalydeco is the first available treatment that targets the defective CFTR protein, which is the underlying cause of cystic fibrosis,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This is a breakthrough therapy for the cystic fibrosis community because current therapies only treat the symptoms of this genetic disease.”

Two 48-week, placebo-controlled clinical studies involving 213 patients, one in patients ages 12 years and older and another in patients ages 6 years to 11 years, were used to evaluate the safety and efficacy of Kalydeco in CF patients with the G551D mutation. In both studies, treatment with Kalydeco resulted in significant and sustained improvement in lung function.

Kalydeco is effective only in patients with CF who have the G551D mutation. It is not effective in CF patients with two copies of the F508 mutation in the CFTR gene, which is the most common mutation that results in CF. If a patient’s mutation status is not known, an FDA-cleared CF mutation test should be used to determine whether the G551D mutation is present.

The most common side effects of Kalydeco include upper respiratory tract infection, headache, stomach ache, rash, diarrhea, and dizziness.

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Recently, Erivedge was approved by the U.S. Food and Drug Administration to treat adult patients with basal cell carcinoma, the most common type of skin cancer. The drug is intended for use in patients with locally advanced basal cell cancer who are not candidates for surgery or radiation and for patients whose cancer has spread to other parts of the body (metastatic).

Erivedge, reviewed under the agency’s priority review program, is the first FDA-approved drug for metastatic basal cell carcinoma. Erivedge was reviewed under the FDA’s priority review program that provides for an expedited six-month review of drugs that may offer major advances in treatment. The drug is being approved ahead of the March 8, 2012, prescription user fee goal date.

Basal cell carcinoma is generally a slow growing and painless form of skin cancer that starts in the top layer of the skin (epidermis). The cancer develops on areas of skin that are regularly exposed to sunlight or other ultraviolet radiation.

Erivedge is a pill taken once a day and works by inhibiting the Hedgehog pathway, a pathway that is active in most basal cell cancers and only a few normal tissues, such as hair follicles.

“Our understanding of molecular pathways involved in cancer, such as the Hedgehog pathway, has enabled the development of targeted drugs for specific diseases,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “This approach is becoming more common and will potentially allow cancer drugs to be developed more quickly. This is important for patients who will have access to more effective therapies with potentially fewer side effects.”

The safety and effectiveness of Erivedge was evaluated in a single, multi-center clinical study in 96 patients with locally advanced or metastatic basal cell carcinoma.

The clinical study’s primary endpoint was objective response rate (ORR) or the percentage of patients who experienced complete and partial shrinkage or disappearance of the cancerous lesions after treatment. Of the patients with metastatic disease receiving Erivedge, 30 percent experienced a partial response and 43 percent of patients with locally advanced disease experienced a complete or partial response.

The most common side effects observed in patients treated with Erivedge were muscle spasms, hair loss, weight loss, nausea, diarrhea, fatigue, distorted sense of taste, decreased appetite, constipation, vomiting, and loss of taste function in the tongue.

Erivedge is being approved with a boxed warning alerting patients and health care professionals of the potential risk of death or severe birth effects to a fetus (unborn baby). Pregnancy status must be verified prior to the start of Erivedge treatment. Male and female patients should be warned about these risks and the need for birth control.

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��P�� lse’s mistake. “Tattoo Nightmares” is created by Sally Ann Salsano (“Jersey Shore”) and 495 Productions.

“Rat Bastards” – An invasive species of giant swamp rats are ravaging America’s Southern wetlands and are especially dangerous to the tenuous ecological system of the Mississippi delta region.  This non-scripted series follows a pack of industrious guys dubbed the “Cajun Commandoes” in Louisiana who hunt these elusive 40-pound menaces both to sell and to eat.

These determined rat hunters compete over a limited four month window to earn big bucks by capturing these loathsome pests for a bounty.  The series is co-created by Eli Holzman and Stephen Lambert of Studio Lambert and Royal Malloy, Duke Straub andColt Straub of American Chainsaw. They are also the production team behind the upcoming Spike series, “Diamond Divers.”

Spike will also create new episodes of “World’s Wildest Police Videos,” which will give viewers access to shocking and outrageous police footage never-before-seen on television.  From high-speed car chases that turn deadly and bank robberies gone wrong to international hostage holdups, the wildest police videos from around the world are on display.

Retired Sheriff John Bunnell hosts the series that is produced by Pilgrim Studios and Pursuit Productions. Executive Producers are Pilgrim Studios’ Craig Piligian andScott Popjes, and Pursuit Productions’ Paul Stojanovich, Jr., Robert Ballantyne and John Bunnell.  The original version was created by Paul Stojanovich Sr. and aired on FOX from 1998-2002.

Spike will air a two-part special, “Urban Jungle Man,” which follows the country’s preeminent extreme animal handler, John Brennan, who rescues, captures and relocates dangerous and exotic animals in New York City’s urban jungle. This non-scripted series chronicles Brennan’s daily adventures as he runs the Urban Animal Relocation team, a privately-owned exotic and dangerous animal relocation service whose perilous missions runs the gamut from removing an alligator from a bathtub to capturing an escaped deadly python.  

Bitten or stung by nearly every animal in existence, Brennan is fearless when it comes to apprehending nature’s deadliest creatures.  “Urban Jungle Man” is produced by Asylum Entertainment and will be shot throughout the country.

Image Courtesy of   http://www.flickr.com/photos/christianacare/

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A Maine food processing and storage company destroyed its cold smoked salmon product under the supervision of the U.S. Food and Drug Administration after inspectors found Listeria monocytogenes within the firm’s facility and on processing equipment.

Based on conditions at Mill Stream Corp. of Hancock, Maine, FDA investigators ordered an administrative detention of the firm’s cold-smoked salmon product, a ready-to-eat food, during an inspection in December 2011. Once the food was detained, Mill Stream Corp. agreed to voluntarily destroy the cold-smoked salmon, under FDA supervision.

The FDA may order the detention of food when an investigator has a reason to believe that the food is adulterated or misbranded. Food subject to an FDA detention order may not be moved, without agency permission, until the agency releases it or the detention order expires. A detention order may remain in place for up to 30 days.

“FDA will not hesitate to take immediate steps to protect the public’s health,” said Dara A. Corrigan, the FDA’s Associate Commissioner for Regulatory Affairs. ”We will aggressively use our enforcement tools to prevent potentially adulterated food from reaching the public.”

Listeria monocytogenes is an organism which can cause listeriosis, a rare and serious illness caused by eating food contaminated with the bacteria. Healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea.

However, listeriosis can be fatal, especially in older people, those with compromised immune systems, and in those with certain chronic medical conditions such as cancer. In pregnant women, listeriosis can cause miscarriage, stillbirth and serious illness or death in newborn babies, though the mother herself rarely becomes seriously ill.

No illnesses have been reported to date from Mill Stream Corp. products. Illnesses or adverse events related to use of these products should be reported to the FDA.

The FDA carried out its action against Mill Stream Corp. under the administrative detention authority for foods as amended as part of the FDA Food Safety and Modernization Act. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

The Agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Columbia Laboratories and Watson Pharmaceuticals has confirmed that the Advisory Committee for Reproductive Health Drugs of the U.S. Food and Drug Administration (FDA) did not recommend approval of progesterone vaginal gel 8% for the reduction of risk of preterm birth in women with short uterine cervical length at the mid-trimester of pregnancy.

While panel members generally agreed that progesterone vaginal gel 8% is safe, the panel stated that more information is needed to support approval. While the FDA will consider recommendations of the Committee, the final decision regarding the approval of the product rests solely with the FDA.  The FDA’s Division of Reproductive and Urologic Products is expected to take action on Columbia’s New Drug Application (NDA) by February 26, 2012.

“We will work with the FDA to address the Advisory Committee’s comments as the Agency finalizes its review of our NDA. We remain confident in the PREGNANT study results that showed the administration of progesterone vaginal gel 8% is a safe and effective treatment for patients at risk for preterm birth due to short uterine cervical length in the mid-trimester of pregnancy. We hope the agency’s final decision will acknowledge the clear unmet medical need in this patient population,” said Frank Condella, President and CEO of Columbia Laboratories.

“As was highlighted today, there are currently no products approved to reduce the risk of preterm birth in women with premature cervical shortening – an established strong predictor of preterm birth risk,” saidFred Wilkinson, Watson’s Executive Vice President, Global Brands.

“The availability of a safe and effective product, with a demonstrated ability to reduce the risk of preterm birth in women with short uterine cervical length in the mid-trimester of pregnancy, would represent a significant advance in the prevention of early preterm birth and its associated complications.”

The Committee evaluated data submitted by Columbia to the FDA in its New Drug Application (NDA 22-139), which includes data from two Phase III clinical trials.  One of these trials, the PREGNANT study, showed that women with a short uterine cervical length as measured by transvaginal ultrasound between 19 and <24 weeks of gestation who were treated with progesterone vaginal gel 8% had a significantly lower risk of preterm birth before 33 weeks gestation compared to those who were treated with placebo (p=0.022).

This study included women with and without a prior history of preterm birth.  Progesterone vaginal gel 8% was also associated with a significant reduction in the risk of preterm birth before 35 weeks gestation (p=0.012).

In the pregnant study, the frequency of maternal treatment-emergent adverse events both overall and by individual event was comparable between the placebo and progesterone vaginal gel treatment groups.

The most frequent events in the progesterone vaginal gel group were expected complications of a high-risk pregnancy and included “premature baby” (19%), “uterine contractions abnormal” (14%), “premature labor” (7%). “Cervical disorder” (10%), “nausea” (10%), “headache” (7%), and “vulvo vaginal mycotic infection” (7%) were also reported.

The Advisory Committee for Reproductive Health Drugs is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational products for use in the treatment of reproductive conditions and makes non-binding recommendations to the FDA.

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The U.S. Food and Drug Administration has completed its recommendations for three user fee programs that will help speed safe and effective drugs and lower-cost generic drug and biosimilar biological products to patients, FDA Commissioner Margaret A. Hamburg, M.D. said on January 13. The recommendations were transmitted to Congress by Health and Human Services Secretary Kathleen Sebelius.

The programs include the fifth authorization of the Prescription Drug User Fee Act (PDUFA), and new user fee programs for human generic drugs and biosimilar biological products. Work on the proposals was concluded before the agency’s mid-January deadline.

Under a user fee program, industry agrees to pay fees to help fund a portion of the FDA’s drug review activities while the FDA agrees to overall performance goals such as reviewing a certain percentage of applications within a particular time frame.

“These final recommendations offer a great example of what can be achieved when the FDA, industry and other stakeholders work together on the same goal,” Hamburg said. “At a time of greater budgetary constraint, user fees provide a critical way for leveraging appropriated dollars, ensuring that FDA has the resources needed to conduct reviews in a timely fashion.”

Said Hamburg: “Human drug user fees have revolutionized the drug review process in the United Statessince they were adopted 20 years ago, allowing the FDA to speed the application review process without compromising the agency’s high standards.”

The proposed user fee programs for generic drugs and biosimilars are modeled on the successful PDUFA program “which has ensured a predictable, consistent, and streamlined premarket program for prescription drugs,” Hamburg said.  As a result of the continued investment of PDUFA resources, the United States now leads the world in first introduction of novel drugs.

PDUFA was created by Congress in 1992 and must be reauthorized every five years. The current program, known as PDUFA IV, will expire on Sept. 30, 2012, unless reauthorized by Congress. FDA’s recommendations for PDUFA V were developed in consultation both with drug industry representatives and with patient and consumer advocates.

Under the recommendations, fees paid by industry would support continued timely review of critical prescription drugs, as well as advance the development of drugs for rare diseases, provide for enhanced communication with small or emerging companies, increase the use of standardized electronic data to improve quality and efficiency, and foster the use of new clinical endpoints that improve drug development times and help address unmet medical needs.

The proposed new Generic Drug User Fee program would provide the FDA with needed funding at a time when generic drug applications are on the rise. Generic drug user fees would help ensure consumers timely access to safe, high-quality and effective generic drugs, which account for two-thirds of all prescriptions dispensed in the U.S.

The FDA receives 800 to 900 new generic-drug-related applications annually. These applications are increasingly complex and frequently involve products manufactured outside of the U.S. In exchange for fees on facilities and product applications, the proposal includes performance metrics such as review timeframes and a commitment to achieve parity between surveillance inspections of foreign and domestic establishments by the 2017 fiscal year. As a result, FDA expects that the proposal would effectively eliminate the review backlog and significantly reduce review times.

A biosimilar is a biological product that is highly similar to a U.S.-licensed reference biological product notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.

The proposed Biosimilar and Interchangeable Products User Fee program is intended for products approved under a new abbreviated approval pathway for biological products shown to be biosimilar to or interchangeable with an FDA-licensed biological product. The Affordable Care Act of 2010 contains a subtitle called the Biologics Price Competition and Innovation Act (BPCI) of 2009, which established this pathway.

Prior to it becoming law, competition in the biologic drug market was stifled. Enactment of BPCI will spark the development of a new segment of the industry, where companies will be able to develop alternative products. This will help spur innovation, improve consumer choice and drive down costs.

The recommended user fee program for biosimilars includes fees for products in development to generate revenue in the near-term and to provide FDA with the resources needed to support development-phase meetings with sponsors of biosimilar biological product candidates.

For more information:

User fees
http://www.fda.gov/ForIndustry/UserFees/default.htm

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The Pew Campaign on Human Health and Industrial Farming recently praised the U.S. Food and Drug Administration (FDA) for limiting the use of cephalosporins in food animal production.

Cephalosporins are vital treatments for children suffering from infection; unlike other antibiotics, such as fluoroquinolones and tetracyclines, they carry no warnings or precautions for pediatric use.  They also are important medicines for treating people suffering from bacterial meningitis and infections of the bone, urinary tract, and upper respiratory system, as well as those associated with cancer.

“We applaud FDA’s move,” said Laura Rogers, project director of the Pew Campaign on Human Health and Industrial Farming. “This restriction is a victory for human health, as it will help ensure we can still rely on cephalosporins to treat life-threatening infections today and in the future.”

Although FDA has approved cephalosporins to treat some infections in food animals, the drugs often are administered in ways not specifically approved by the agency.  Its rule will apply to such extralabel use of cephalosporins in meat and poultry production, which multiple studies have linked to the emergence of cephalosporin-resistant bacteria that can infect people.

If cephalosporins continue to be overused on industrial farms, these drugs will lose their effectiveness.  As a result, many human infections will become more difficult to treat, leading to more deaths and higher health care costs.

“This action is a good first step,” added Ms. Rogers, ”and we encourage FDA to issue guidelines expeditiously that restrict the overuse and misuse of other critical antibiotics on industrial farms.”

In 2010, officials from FDA, the U.S. Department of Agriculture, and the Centers for Disease Control and Prevention testified before Congress that there was a definitive link between the uses of antibiotics in food animal production and the crisis of antibiotic resistance in humans.  In addition, many medical organizations including the American Medical Association, the American Academy of Pediatrics and the World Health Organization warn that this practice is putting human health at risk.

To ensure additional human antibiotics work when we need them, the Pew Campaign on Human Health and Industrial Farming also urges Congress to pass the Preservation of Antibiotics for Medical Treatment Act (H.R. 965, S. 1211). A 60-day public comment will follow FDA’s announcement, during which Pew will submit a formal response to the agency.

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The American Veterinary Medical Association has announced that the FDA’s order prohibiting certain uses of cephalosporins in food animals appears consistent with the current AVMA position on the limited prohibition on extra-label drug use, but warned against further restrictions not backed by science.

Cephalosporins, a class of antimicrobial drug used in livestock, poultry, and other food-producing animals, are also commonly used in humans to treat pneumonia and a wide range of skin and soft tissue infections, urinary tract infections, and inflammatory disease. The FDA said it is limiting the use of cephalosporins in animals to preserve the effectiveness of the drugs for treating disease in humans and reduce the risk of cephalosporin resistance in certain bacterial pathogens.

“The AVMA is pleased that the FDA reviewed and thoughtfully considered the many comments received from stakeholders, including veterinarians, while taking action to preserve the effectiveness of cephalosporin drugs for treating disease in humans,” said Dr. Rene Carlson, AVMA president. ”

Veterinarians are committed to improving the health and welfare of people, animals, and the environment, and we hope the FDA’s order will allow veterinarians to have therapeutic options for food animals while also protecting public health.”

The AVMA is evaluating the prohibition of cephalosporins for preventive uses and will submit a response to the FDA during the comment period. The AVMA has a strong position which underscores the importance of veterinary access to antimicrobials for preventive use to enhance food safety, public health, and animal welfare.

“We are committed to the judicious use of antimicrobials in food animals,” said Dr. Carlson. “While this measure appears to be consistent with our position, we will continue to review any further restrictions to make sure they are backed by science and don’t place arbitrary and ultimately harmful limits on veterinarians’ ability to treat animals and ensure a safe and healthy food supply.”

The AVMA, founded in 1863, is one of the oldest and largest veterinary medical organizations in the world, with more than 81,500 member veterinarians worldwide engaged in a wide variety of professional activities.

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