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Arsenic in Apple Juice

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apple juice arsenic

FDA decided that the arsenic level in apple juice should be equal to the one in the water.

FDA found arsenic and other toxins in the apple juice coming from plant in Yakima Valley. The apple juice samples revealed levels of inorganic arsenic that were eight times higher than the limit set by the governmental agency.

The sample contained arsenic as much as 88.1 parts per billion, while the FDA recommendation is only ten parts per billion.

Arsenic and Old Pesticides

Even if arsenic is a natural component that can be found in air and the water, in high quantities or at repeated exposures it can produce maximum damage.

Inorganic arsenic can provoke risks of cancer, diabetes, skin lesions, cardiovascular disease, developmental effects, or neurotoxicity.

Food safety specialists say that it is possible that the arsenic was sourced from apples coming from an old orchard. The arsenic traces are linked to the use of pesticides several years ago.

The toxic substance does not degrade over time. Therefore, if it had been utilized in the orchid years ago, the substance could have been trapped in the soil and afterward transmitted to the apple trees.

Even so, food specialists say that it is the full responsibility of the facility to control the quality of raw materials and to perform analysis to make sure that the products are perfectly safe.

Experts recommend the manufacturer to test all incoming apples from each of their suppliers in order to verify which one of them is the inorganic arsenic source.

The factory officials declared that the facility operates in compliance with all rules and regulations.

Apple Mold and Patulin

FDA reported that the manufacturer had stored apples outdoors for several months, which encourages mold cultures and affects the fruits’ quality.

The apple mold produces a toxin called patulin that is genotoxic. Patulin was considered to be a group 3 carcinogen, and it can determine symptoms such as gastrointestinal problems, pulmonary congestion, edema or convulsions.

The tolerable daily intake of patulin was set to 0.3 mg/kg per week, and FDA inspects food units to verify if the manufacturers don’t engage in practices that may increase the toxin’s level in their final products.

The findings of the inspection show violations of the Hazard Analysis and Critical Control Point regulations. Children can be more affected by the toxins than adults.

Until now, the Yakima Valley production unit tried to blend batches of juices to dilute the toxins. However, FDA warns that this measure may not be the best way to remove the risks.

In 2013, FDA imposed a new rule for producers imposing that the arsenic level in apple juice should be just as small as the one that can be found in water.

Image Source: Wikipedia

BioMarin Recalls Kyndrisa from EU Markets

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BioMarin Headquarters in San Rafael, California

The California-based pharmaceutical company will have to resist new treatment rejection on both US and EU markets.

BioMarin, the pharmaceutical company, recently announced that it will stop the development of a muscular dystrophy treatment that was undergoing in the European market. The recall came after the European Medicines Agency offered a negative opinion on the effectiveness of the cure.

BioMarin Market Tentatives

The company, which already tried and failed to enter the US market with the new treatment, has also received a negative review from the European legislators. It is thus forced to discontinue the treatments and to retract the existing medicines from the market.

BioMarin will also have to stop the projects of three other products that are currently in Phase II of the development.

The pharmaceutical company decided to join efforts with regulatory authorities, doctors, and patient groups in order to offer a transition plan for patients that are currently following the soon-to-be stopped Kyndrisa treatment.

The decision had an adverse impact on the company’s stocks, which dropped 29% in comparison with the same period of the last year.

The company is intending to continue the development of oligonucleotides that are used in the cure of Duchene Muscular Dystrophy, as it is in a continuous fight to protect its patent. Last fall, BioMarin just fought and won Sarepta on an initial ruling concerning this matter.

This new treatment was a project based on the 2014 BioMarin acquisition of Prosensa. Soon after the tests showed that the pills had little to no effects, GlaxoSmithKline refused to continue the collaboration with BioMarin. Still, the company continued the cure development by itself and tried to find a treatment solution that would delay the disease progression.

Treatments for Muscular Dystrophy

MDM is a genetic disorder involving muscle degeneration and weakness in boys. The prevalence is one in 3,500 – 5,000 cases. DMD is an effect of dystrophin absence. The symptoms appear in early childhood, and by adolescence, it gets to affect the heart and the respiratory muscles.

Despite the fact that the medicines were withdrawn from the EU market, BioMarin expects to have excellent results in prospecting different solutions for MDM in 2017.

Another pharmaceutical company that intends to obtain approval for an MDM treatment is Sarepta Therapeutics. Last week, the company announced that the Food and Drug Administration has prolonged the term of issuing an opinion on its new medicine, eteplirsen. Sarepta Therapeutics still has hopes that the approval will come soon.

Image Source: Wikipedia

Study Reveals, ‘Minors’ Can Easily Buy E-cigarettes Online

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e-cigarette

In a study analyzing compliance with North Carolina’s electronic cigarette age-verification law, scientists have observed that minors are easily able to circumvent legislation and purchase electronic cigarettes from retailers through the Internet.

“Even despite state laws like North Carolina’s obliging age confirmation, most vendors keep on failing to confirm age as per the law, underscoring the need for vigilant enforcement,” said buy the authors of the study, published in JAMA Pediatrics journal.

Sales of e-cigarettes have been continually on the ascent since they first entered the US market in 2007. By 2013, it had turned into a $2 billion-a-year industry and experts foresee sales could reach $10 billion-a-year by 2017.

As per the Centers for Disease Control and Prevention (CDC), rates of e-cigarette use among youngsters are likewise increasing quickly, twofold from 2011 to 2012. The CDC report that in 2013, more than a quarter of a million high school students had never smoked ordinary cigarettes yet had utilized e-cigarettes.

E-cigarettes are often depicted as a more secure option to smoking traditional cigarettes, in spite of the fact that groups like the US Food and Drug Administration (FDA) and the Mayo Clinic are careful about their nicotine substance and links with potentially cancer-causing substances.

At present, 41 states ban the sale of e-cigarettes to minors, including North Carolina. As per the study authors, though, further research has yet to be carried out to analyze age confirmation among Internet retailers that offer e-cigarettes.

For this study, Rebecca S. Williams of the University of North Carolina at Chapel Hill, and associates set out to analyze how often online sellers consented to North Carolina’s age-verification law.

‘E-cigarette vendors online operate in a regulatory vacuum’

The researchers’ selected 11 nonsmoking minors matured 14-17 to make e-cigarette purchases online with a credit card while under supervision. The minors made their buy attempt from computers at the project’s offices.

Almost 98 Internet e-cigarette vendors were targeted by the study. The minors effectively ordered e-cigarettes from 75 of these vendors and of the unsuccessful orders, just five failed because of age verification. As per the authors, this implied that 93.7 percent of the e-cigarette merchants researched failed to accurately confirm their clients’ ages.

Besides this finding, the e-cigarette packages were conveyed by shipping companies that all failed to verify the ages of the buyers upon delivery, with 95% of orders simply left at the door. The majority of the shipping companies concerned do not dispatch cigarettes to purchasers, as indicated by company policy and federal regulation.

According to the study findings, none of the online e-cigarette sellers followed North Carolina’s e-cigarette age-verification law.

“Lacking federal regulation, youth e-cigarette use has increased and e-cigarette vendors’ online work in a regulatory vacuum, utilizing few, if any, efforts to avoid sales to minors,” they wrote.

The results of this study will be of concern to those who are worried about the influence of e-cigarettes. The CDC also report that among nonsmoking youth who have ever used e-cigarettes, 43.9% say they “have intentions” to smoke conventional cigarettes, compared with 21.5% who have never used an e-cigarette.

“Federal law should require and enforce careful age verification for all e-cigarette sales as with the federal PACT (Prevent All Cigarette Trafficking) Act’s requirements for age verification in Internet cigarette sales,” study authors said.

Lately, Medical News Today reported on a study recommending that the introduction of new regulations that could modify the content of cigarettes is unlikely to significantly affect the current demand for illicit tobacco.

Research Proves: 12% of Americans are inappropriately using Aspirin

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side effects of aspirin

Aspirin have relatively more side effects as compared to the benefits, according to a latest study.

A research shows that the majority of Americans like to take low dose of Aspirin every day.  Generally, patients believe that aspirin can slash down the hazards of heart attacks and strokes.

A group of experts at Baylor College of Medicine in Houston assessed the aspiring guidelines of different health organization.  The research found that published guidelines of institutes such as American Heart Association suggests that regular use of aspirin is harmful for the patients of cardiovascular diseases.

Afterwards, researchers accumulated the data of 69,000 patients from the National Cardiovascular Registry Practice Innovation and Clinical Excellence (PINNACLE). The data uncovered that nearly12 percent of heart patients of the United States are taking aspirin unnecessarily since a long time

Surprisingly, the rate of female patients is comparatively higher than male cardiovascular patients.

A few years ago, the food and Drug Administration (FDA) warned Americans about the inappropriate use of aspirin. The federal health agency advised that the particular drug should not be prescribed for the primary prevention of heart attack.  Hence, the recent study also demonstrates that aspirin does not lessen the risks of first stroke.  It only increases the chances of stomach bleeding, gut bleeding and hemorrhagic strokes in people.

The report is printed in detail in the Journal of the American College of Cardiology

HPV Test Certified For Primary Cervical Cancer Screening

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new HPV test

Recently, the society of Gynecologic Oncology and the American Society for Colposcopy and Cervical Pathology announced that Human Papilloma Virus (HPV) test is extremely effective to identify cervical cancer.

The health organizations also confirm that this screening can replace the present US cytology based cervical cancer test. The guidance report merely considered it as primary HPV test and explained its advantages and side effects. Additionally, it recommends that basic HPV screening should begin from the age of 25. However, women who are younger than the given age should go for current Pap test only.

The two most prominent women’s health organizations received FDA approval for   the cobas HPV test. The government health agency officially permitted it as a basic test for cervical cancer screening.

On the other hand, the American College of Obstetricians & Gynecologists (ACOG) is completely against the new test.  The biggest ob-gyn group of the United States believes that women should still get Pap test alone. However, they can take this new test with a combination: HPV test and Pap test.

Warner K. Huh MD, a researcher at University of Alabama informs that HPV screening is extremely sensitive. It relies on subsequent assessment strategies and regular screening.  The approval of US Food and Drug Administration does not contain recommendation to implement the new screening in the Untied States.

The study is printed in detail on 7th January’s edition of Journal Gynecologic Oncology.

Novartis Submits Two COPD Treatment Drugs For Regulatory Approval

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Novartis filed request

Novartis, a Swiss multinational pharmaceutical company announced that soon it would submit two drug applications to U.S Food Drug and Administration. The new drugs would fight against chronic obstructive pulmonary disease (COPD).

The drug manufacturer filed the request for the two drugs at the end of the 2014. The drugs, QVA149 and NVA237 successfully passed the third test. It showed considerable improvement in the functioning of lungs.

The two medicines have already touched the markets all around the globe except the United States. Hence, the company has now completed the submission process of the two drugs in the United States.

The World Health Organization says that drug makers are trying really hard to introduce new respiratory treatment. The latest report shows that after every 10 seconds a person dies due to Chronic Obstructive Pulmonary Disease (COPD). The disease is expected to become the third largest death factor till 2020.

FDA Requires Calorie Count, Even For Movie Theater Popcorn

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FDA-requires-calorie-count

New labeling requirements for ready-to-eat food mean you will soon see calorie count from movie theater popcorn to sugary cocktails. The US government is ready to publish extensive new rules that will oblige chain restaurants to unveil calorie counts on menus, making a national standard that seizes the current patchwork of state laws and applies to restaurant networks with 20 or more outlets.

The new long-awaited rules, which are a part of the 2010 Affordable Care Act, were advertised by the Food and Drug Administration and also apply to huge retailing machine administrators. As per the new guidelines, calories must be shown on all menus and menu sheets. Other nutritional data – including calories from fat, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrates, fiber, sugars and protein – must be made accessible in the inscription upon demand.

Margaret Hamburg, FDA Commissioner said on a conference call with columnists on Monday, “Obesity appears to be a national pandemic that affects a lot of Americans. Conspicuously, Americans consume and drink around a third of their calories far from home.”

The last rule, dissimilar to a proposal issued in 2011, includes cinemas and entertainment parks. It also includes alcoholic beverages served in restaurants, however, not beverages blended or served at a bar.

The org said it rolled out improvements to its proposal after considering more than 1,100 remarks from industry, public health advocates and customers. It limits the scope of food covered to visibly concentrate on restaurant-type sustenance. Foods, for example, deli meat purchased at a store counter will be avoided.

The restaurant business responded positively to the progressions.

“We accept that the Food and Drug Administration has decidedly dealt with the territories of most prominent concern,” said Dawn Sweeney, CEO of the National Restaurant Association, which represents 990,000 restaurant and food-service outlets.

A few organizations as of now show calorie data. Panera Bread Co in 2010 turned out to be the first to deliberately show calorie data at all its bistros across the country. Others, including McDonald Corp and Starbucks Corp, went with the same pattern.

Foods covered by the new calorie rule include, menu items at sit-down restaurants, takeout food, bakery items, ice cream from an ice-cream store, pizza, labeled by the slice and by whole pie. Moreover, seasonal menu items, for example, Thanksgiving dinner, day by day specials and standard sauces will be absolved.

Hamburg accredited that calorie counts for pizza wedges and several other foods made on the premises will vary and may not generally be accurate. Restaurants may draw on a range of databases, cookbooks and food package labels to compute the calorie counts.

“The organization did not observe a genuine effect on its business from menu labeling. Of course, there would be a hop in sales of higher calorie items to lower calorie items,” Katie Bengston, Panera’s nutrition manager said.

Restaurants have one year to conform to the new rules after subsequent publication in the Federal Register. Retailing machine administrators have two years to go along.

The guidelines intend to close a loophole in the 1990 Nutrition Labeling and Education Act, which secured food labeling on most items, however not restaurants or other ready-to-eat foods.

 

 

Roche’s breast cancer medicine “Perjeta” shows to significantly prolong patient’s lives

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Roche-breast-cancer-medicine

A latest report published on Sundays that a medicine used to cure advanced breast cancer has had what appears to be an exceptional success in extending lives in an experimental trial.

Doctors observed that patients who got the medicine Perjeta, from the Swiss drug maker Roche had a median survival time nearly 16 months longer than those in the control group.

That is the greatest quantity of time for a medicine used as an early cure for metastatic breast cancer, the investigators said, and it may be one of the best ever treatment of any cancer. Nearly all cancer medicines extend survival in patients with metastatic disease for a few months at most, metastasis means the cancer has increased in other parts of the body.

Dr. Sandra M. Swain, the lead investigator of the study said that we’ve not at all seen something like this before and it’s really exceptional to have this survival advantage.

The consequences were being demonstrated on Sunday in Madrid at the yearly meeting of the European Society for Medical Oncology and at this meeting Dr. Swain has been a paid presenter for the company.

An earlier examination of the medical trial recognized that Perjeta, known commonly as pertuzumab, enhanced survival by a statistically large amount, but until now it was not famous by how much, because patients had not been pursued long enough.

Perjeta, like the better-recognized Roche drug Herceptin, or trastuzumab, obstructs the action of a protein called HER2, which encourages the development of some breast tumors and Perjeta is designed to be used with Herceptin for the approximately 20 percent of breast cancers distinguished by an abundance of HER2.

The revolutionary drug Perjeta was approved by the FDA because it reduces the side effects normally related to cancer-fighting medicines.

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