Shock treatment sparks FDA concern

Massachusetts Center is only place in entire country that uses skin shocks as aversive conditioning for aggressive disabled patients

BOSTON Self-injury is one of the most difficult behaviours associated with autism and other developmental or intellectual disabilities, and a private facility outside Boston that takes on some of the hardest-to-treat cases is embroiled in a major debate: Should it use electrical skin shocks to try to keep patients in control?

The US Food and Drug Administration (FDA) is considering whether to ban devices used by the Judge Rotenberg Educational Center in Canton, Massachusetts, the only place in the country known to use skin shocks as aversive conditioning for aggressive patients.

It's a rare move by the FDA, following years of complaints from disability rights' groups and even a UN report that the shocks are tantamount to torture.

"We really wanted to take a much more focused and rigorous look at it," FDA Commissioner Margaret Hamburg said. "There's a lot of concern about the downside of this approach and the risk to the patients."

Rotenberg must get a court's approval to begin administering skin shocks to a student. The centre uses a graduated electronic decelerator (GED), attached to arms or legs. If the student starts head-banging, throwing furniture or attacking someone, then a worker can press a button to activate the electrode, delivering a two-second shock to the skin.

Some patients compared the shocks to a hard pinch or bee sting, but some said it was like being stung by a thousand bees.

At an FDA advisory committee hearing this year, most neurology and ethics experts concluded the device poses an unreasonable and substantial risk, while acknowledging that other therapies don't work for everyone.

Rotenberg's executive director, Glenda Crookes, calls the shocks a last resort coupled with positive behaviour programmes, such as rewarding students with time at JRC's Internet cafe or arcade games. The two-second shock is quick but painful enough to jar the patient out of the harmful episode. Of the 235 patients, 55 are being treated with skin shocks. Most are in their 30s; five are between age 17 and 21.

www.punemirror.in

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Remote-controlled contraception sounds amazing but is it susceptible to hacking?

You could be saying goodbye to these fellas (Picture: Getty)

In the latest example of mankind’s rapid descent into extreme inertia, it was announced yesterday that remote-controlled contraception could be available by 2018.

Forget remembering to take the contraceptive pill (if that’s possible?) because soon you’ll be able to let technology handle all your birth control needs. Gulp.

Actually, we won’t lie, it sounds sort of amazing.

A company called MicroCHIPS, which is based in Massachusetts and is backed by Bill Gates no less, has developed a tiny contraceptive computer chip (measuring 20mm x 20mm x 7mm) that can be implanted under a woman’s skin, releasing a small dose of the hormone levonorgestrel.

The chip lasts for 16 years and, this is the really interesting bit, the daily dose can be stopped at any time using a wireless remote control. So, if you suddenly decide you want to get pregnant, you can just turn it off. Simple, right?

Let’s hope it doesn’t look like the TV remote – awkward (Picture: IPGGutenbergUKLtd)

But, the glaring issue with using wireless technology is the very real possibility of hacking. Yes, someone could hack your contraceptive. Think about it, evil exes with a grudge, broody partners *starts to hyperventilate*.

The creators are, however, currently working on a way to make the chip completely secure. Oh good.

And, should it get approval, the same technology could be used to administer other drugs.

MORE: This proves your contraception isn’t working as well as you think

Simon Karger, head of the surgical and interventional business at Cambridge Consultants, told the BBC that though implanted technology faces some obvious risks and challenges, he and colleagues ‘foresee a future in which a huge range of conditions are treated through smart implanted systems.’

The chip will be submitted for pre-clinical testing in the US next year – and could possibly be on sale by 2018.

Source:

metro.co.uk

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Business Briefs: 7/8/14

Mice, birds prompt NYWP consumer alert

The Allegheny County Health Department posted a consumer alert at NYWP Enterprise in McKees Rocks last week after finding mice and birds in the facility. An inspector also reported mouse and bird droppings on bags of food, according to a Thursday inspection report. NYWP supplies Asian restaurants. Inspection reports for food facilities in the county are available online at webapps.achd.net/​Restaurant/.

AHN and Johns Hopkins formalize cancer care deal

A five-year cancer care collaboration agreement first announced in January between Allegheny Health Network and Johns Hopkins has been formalized. Under the agreement, AHN cancer patients will have access to clinical trials being conducted at Hopkins and AHN physicians will be able to consult on difficult cases with their counterparts at Hopkins’ Sidney Kimmel Comprehensive Cancer Center. The Kimmel center is one of 41 U.S. facilities designated by the National Cancer Institute as a comprehensive cancer center, as is the University of Pittsburgh Cancer Institute.

Germany takes aim at foreign drivers with car toll

Germany plans to introduce a car toll in 2016 that seeks to make money from the millions of foreigners who drive through the country every year, the transport minister said Monday. Germany has a truck toll but, unlike many European countries, no car toll. The cheapest option, the 10-day sticker, will cost 10 euros ($13.60).

Truckers strike at California ports

Truckers in a long-running dispute with three companies at the ports of Los Angeles and Long Beach have started what they say is an indefinite strike. The truckers argue they are full-time employees, not independent contractors, and should be paid accordingly. Truckers’ spokeswoman Barb Maynard says workers formed picket lines Monday morning outside the companies’ yards.

Deal adds natural flavors to ADM portfolio

Agribusiness giant Archer Daniels Midland already makes sweeteners, vegetable oils and an array of other ingredients used in packaged foods and drinks. Now it’s getting in the natural flavors business. The company, based in Decatur, Ill., said Monday it will acquire the privately held Swiss company Wild Flavors in an all-cash deal that will total $3.13 billion counting debt.

Truckers strike at California ports

Truckers in a long-running dispute with three companies at the ports of Los Angeles and Long Beach have started what they say is an indefinite strike.

The truckers argue they are full-time employees, not independent contractors, and should be paid accordingly.

Truckers’ spokeswoman Barb Maynard says workers formed picket lines Monday morning outside the companies’ yards.

Source:
www.post-gazette.com

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Ebola outbreak: Ghana tests US man

Ebola spreads through contact with an infected person's bodily fluids

A US citizen is being tested for the Ebola virus in Ghana, which has had no confirmed cases of the virus in the current West African outbreak.

The man has been quarantined at the private Nyaho Clinic in the capital, Accra, health officials say.

The virus has so far killed more than 460 people since it broke out in Guinea in February and spread to neighbouring Liberia and Sierra Leone.

It is the world's deadliest outbreak to date and there is no cure for Ebola.

The US embassy in Accra said it had been informed that a US citizen was being tested but would not give any more details, Reuters news agency reports.

'Under control'

The man was believed to have visited Guinea and Sierra Leone in recent weeks.

Ghana's health ministry said it had put in place "precautionary measures" and people should stay calm.

Staff at the clinic had also been quarantined and provided with protective clothing, it added in a statement.

Ebola virus disease (EVD)

• Symptoms include high fever, bleeding and central nervous system damage
• Fatality rate can reach 90%
• Incubation period is two to 21 days
• There is no vaccine or cure
• Supportive care such as rehydrating patients who have diarrhoea and vomiting can help recovery
• Fruit bats are considered to be the natural host of the virus

In pictures: Battling Ebola in West Africa

Why Ebola is so dangerous

The clinic was awaiting the results of blood tests to see whether the patient, whom the ministry did not identify, really had Ebola, the statement said.

"We will like to assure the general public that we have everything under control," Tony Goodman, the health ministry's public relations officer, said.

In April, Ghana's health authorities said a girl suspected to have Ebola had tested negative.

Ebola spreads through contact with an infected person's bodily fluids and kills up to 90% of those infected.

The health ministers of 11 West African states met in Accra last week promising to work more closely together to combat the outbreak.

So far, 759 people have been infected with the virus in Guinea, Liberia and Sierra Leone.

Most of the 467 deaths have been centred in the southern Guekedou region of Guinea, where the outbreak was first reported.

But health officials say the region's porous borders have allowed infected people to carry the disease into other countries.

Source:

www.bbc.com

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Smartphones allow do-it-yourself stress hormone tests

This new health app will be able to measure your stress levels in only 10 minutes.

The next addition to the collection of health apps coming online for smartphones may be a stress test, researchers said at a recent conference.

With a simple tube, some software and a saliva sample, people and their doctors can measure levels of the stress hormone cortisol, according to new research presented last week at ICE/ENDO 2014, the joint meeting of the International Society of Endocrinology and the Endocrine Society in Chicago.

"We have designed a method by which anyone with a smartphone will be able to measure their salivary cortisol level quickly, easily and inexpensively," said lead investigator Dr. Joel Ehrenkranz, director of diabetes and endocrinology at Intermountain Healthcare in Murray, Utah.

Read: Stress hormone linked to PTSD in women

While a commercial lab in the United States may charge up to $50 to run a quantitative salivary cortisol test and take up to a week to provide the results, the smartphone test will cost under $5 and give results in less than about 10 minutes, Ehrenkranz told Reuters Health in an interview.

"Parts of the United States and the rest of the world that lack facilities to measure cortisol will now be able to perform this essential diagnostic test," he said. "Also, measuring salivary cortisol with this technology will provide a way for individuals to monitor their personal biometric stress levels easily and inexpensively."

Ehrenkranz and his research team would like to see healthcare providers around the world, especially in low-resource areas, use the smartphone test to help diagnose disorders involving excessive cortisol or depletion of the hormone, and to allow cortisol levels to be monitored easily over time.

They'd also like the public to monitor their own cortisol levels whenever they want. So they designed their device to be inexpensive to manufacture, and easy to use on all cell phones, all platforms and all form factors.

It consists of a case, a light pipe, and a lens; it uses no battery power and it's unbreakable and reusable, they say.

For the developing world, it needs to be inexpensive, Ehrenkranz said, and it costs only about $1 to make.

Read: Stress hormone in womb may cause daughters to smoke

Project collaborator Dr. Randall Polson, senior optical engineer in the College of Engineering at the University of Utah in Salt Lake City, wrote in an email, "We are trying to make sure a skilled 8th-grader - a 12-year-old - can get accurate results."

"The measurement system's smartphone and reader act as a photo studio ... The complex and difficult processes are put into the strip chemistry and embedded into the smartphone application, so if you have a charged phone and a test kit you can get accurate results without complicated infrastructure and highly trained technicians," Polson wrote.

To take the test, a person puts a straw-like saliva collector under the tongue, and capillary action wicks the saliva to an assay strip in a cassette that's inserted into a reader; the reader aligns a lens and light diffuser with a smartphone's camera and flash. A few minutes later, the smartphone image analysis app quantifies the cortisol value.

Dr. Ehrenkranz said the first screening test for hypercortisolism is salivary cortisol, and that 3 percent of people with type 2 diabetes actually have Cushing's disease - of which excess cortisol would be a sign - but they don't get screened because their doctors don't have access to the technology.

It will also help individuals, Ehrenkranz said. As an example, he cited the 10 percent of people with depression who have psychotic depression, with cortisol levels that rise before the onset of psychosis. Using this device, people at risk for psychotic depression will be able to check their salivary cortisol level every day and take steps to avoid a psychotic break.

The Ministry of Public Health of Thailand plans to introduce the cortisol test later this year, as a consumer product to monitor individuals' stress, Ehrenkranz said. His team is collecting clinical data to submit to the FDA to gain approval to market the test as a class 2 medical device, which they hope will be granted in 2015.

Source:

www.health24.com

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18 percent of high school seniors smoke hookahs

Eighteen percent of high school seniors reported smoking hookahs during the past year, and the majority of those teens were urban white males, a study by researchers at New York University Langone Medical Center found.

The study, based on a national survey of more than 5,000 high school seniors, found that white students were more likely than black students to use a hookah. Urban students and boys also reported higher hookah use, along with those who said they currently smoked cigarettes or also had ever used alcohol, marijuana, or other drugs. Students with more educated and affluent parents, or who held a job that paid more than $11 per week, were also more likely to smoke a hookah.

Previous studies suggested that teens believe that hookah use is less harmful and addictive than cigarettes. Education efforts about the dangers of hookah smoking should be geared toward urban high school students with high socioeconomic status, the researchers wrote.

BOTTOM LINE: Eighteen percent of high school seniors smoke hookahs.

CAUTIONS: The study relied on self-reported answers, which may not be accurate.

WHERE TO FIND IT: Pediatrics, July 7

C-section linked to increased risk of future stillbirth, ectopic pregnancy

Women who have a caesarean section may have a small increased risk of a subsequent stillbirth or ectopic pregnancy, a European study suggests.

For the study, which is the largest to look for a link between C-sections and stillbirths, researchers in Ireland analyzed data from Denmark’s national registry that included more than 800,000 women who gave birth to their first child between 1982 and 2010. The women were divided into two groups depending on whether they had a C-section or a vaginal delivery, and the researchers looked at the outcomes of their subsequent pregnancies.

Women who had C-sections were 14 percent more likely to have a later stillbirth — which translated to a risk of 1 additional stillbirth for every 3,000 C-sections. Having a C-section also raised the risk of a future ectopic pregnancy by 9 percent — or 1 per 1,000 C-sections. The researchers found no increased risk of miscarriage among women who had a C-section.

The overall chance of having a stillbirth or an ectopic pregnancy is small, the researchers wrote, so their findings suggest only a slight increase in risk after a C-section. However, women who choose to have one that isn’t medically necessary should consider these findings, they wrote.

BOTTOM LINE: Women who have a caesarean section may have a slightly increased risk of a subsequent stillbirth or ectopic pregnancy.

CAUTIONS: The study cannot prove a cause-and-effect relationship between C-sections and subsequent pregnancy complications. The study did not take into account changes in prenatal and neonatal care and C-section techniques over time, which may have affected the results.

Source:

www.bostonglobe.com

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Girl Scarred in Pit Bull Attack, and at Center of KFC Controversy, to Get Prosthetic Eye

Victoria Wilcher — the 3-year-old Mississippi girl whose family claimed was asked to leave KFC because of her appearance — will be fitted for a prosthetic eye.

Victoria, who lost sight in her right eye and was left with severe facial scars after a pit bull attack, will meet with Raymond Peters, an ocularist who hopes to outfit her with a prosthetic eye this week at his office in Naples, Florida.

An ocularist is a trained technician who makes prosthetic eyes.

Peters said he doesn’t care about the controversy surrounding what her family said happened to her at KFC. He just wants to help a child in need.

“That’s another world as far as I am concerned. That’s not going to affect me with how I help the child,” he said of the KFC incident. “I am focused on this child, and if that did happen, it’s sad because it is a double tragedy for the child.”

Victoria’s grandmother, Kelly Mullins, took to Facebook last month to tell a story about how Victoria, who wears an eye patch and eats through a tube, was told to leave a KFC in Mississippi because her appearance was disturbing to other patrons.

The story went viral. Online fundraising campaigns brought in thousands, including $30,000 and an apology from KFC.

But veracity of the story has since been called into question. A pair of investigations found no proof she was ever asked to leave KFC and a local newspaper also cast doubt on the family’s story.

Both Peters, who has donated his services and assisted with travel accommodations, and Mullins spoke to CNN Sunday about Victoria’s road to recovery .

“She don’t have an eye socket and no cheekbone,” said Mullins. “We had to put her back in diapers because of the wounds on her legs. She can’t pull things up and down on them. The wounds will bleed, and she screams bloody murder.”

Not knowing the full extent of the damage, Peters said he is not even sure if an artificial eye is a feasible option. But that is not going to stop him from trying.

“I will help her as long as I am able,” he said. “We don’t want this child to walk in the shadows.”

Despite saying it hadn’t found proof that one of its restaurants mistreated the girl or her grandmother, KFC said it will still honor its commitment to donate $30,000 to assist with Victoria’s medical bills.

“We hope everyone keeps Victoria in their thoughts and prayers,” the chain said in a statement last month. “She will certainly be in ours.”

Source:

ktla.com

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AIDS researcher pleads not guilty to fakery counts

DES MOINES, Iowa (AP) — A former Iowa State University scientist has pleaded not guilty to charges alleging that falsified his research for an AIDS vaccine to secure millions of dollars in federal funding.

Dong-Pyou Han appeared in federal court in Des Moines on Tuesday and entered his pleas of not guilty to four counts of making false statements. Each count carries up to five years in prison and a $250,000 fine.

Han was released on bond and his trial was scheduled for Sept. 2. His attorney declined to comment afterward.

Prosecutors say before Han resigned last fall, he told university officials he had spiked samples of rabbit blood with human proteins to make it appear the vaccine was working.

The alleged misconduct was uncovered last year after Harvard University scientists discovered the spiked samples.

Source:

www.boston.com

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Consumption of More Fruits and Vegetables Does Not Lead To Weight Loss

The researchers in University of Alabama, Birmingham, stated that eating more vegetables and fruits in a diet of the person has no effect on weight loss, as told by the recommenders who tell people looking forward to lose weight to have more of them in order to be in their dream shapes.

A research was conducted on 1,200 subjects wherein they were told to eat more vegetables and fruits n their daily diets in order to check whether it helps in losing weight for them or not.

According to Kathryn Kaiser, the instructor of UAB School of Public Health, there was no effect on people looking forward to lose weight by the consumption of vegetables and fruits. In fact, there were zero results observed by the research team in this experiment.

She also added that eating more will not have a good approach towards losing weight as by adding them on top of other things preferred to be eaten by the people will not have any weight change in the individuals.

According to a study published in American Journal of Clinical Nutrition in the month of June, while eating more of vegetables and fruits does not make a person lose weight, eating more of it does not make him gain weight either.

Kaiser included that there is no observation of an increased weight in a person with an added serving size of fruits. This states that fruits help in meeting the daily requirements of an individual’s body to have fiber and vitamins.

She also stated that instead of increasing the intake of vegetables and fruits, there is a need to reduce the intake of calories that can be done by the intake of proper food.

There has been a popular belief among people that in order to lose weight, it is essential for them to have vegetables and fruits in larger quantities, however, this belief has now been shattered.

Source:

yottafire.com

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Egypt’s army says ‘virus cure’ needs more tests

FILE - This file image made from undated video broadcast on Egyptian State Television on Tuesday, Feb. 25, 2014 shows a device that the Egyptian army claims will detect and cure AIDS and Hepatitis. Egypt’s military said Saturday, June 28, 2014 that devices it earlier claimed it invented to detect and cure AIDS and hepatitis C need six more months of testing. The army had earlier promised to reveal the technology to the public this coming Monday after making what experts dismissed as an outlandish claim last February. (Associated Press)

CAIRO — Egypt’s military said Saturday that a device it claimed it invented to cure AIDS and hepatitis C needs six more months of testing.

The army had earlier promised to reveal the technology to the public this coming Monday after making what experts dismissed as an outlandish claim last February.

At a news conference then, the head of the army’s Engineering Agency said the military had produced an “astonishing, miraculous” set of inventions that could detect AIDS, hepatitis and other viruses without taking blood samples and also purify the blood of those suffering from the diseases.

The claim caused uproar among scientists and the public, with many pointing out that the technology had not been properly verified. It was also lampooned in a famous satirical program that has now been taken off the air.

The assertion hit a sensitive nerve in Egypt, where Hepatitis C is an epidemic. Some studies estimate that up to 10 percent of 86 million Egyptians have it, making it the country with the highest prevalence in the world.

In a press conference held in a military hospital in Cairo Saturday, a military doctor said the blood purification device needed further tests before it could be released to the public.

“Scientific integrity mandates that I delay the start of the public release until the experimentation period is over, to allow for a follow up with patients already using it,” Egypt’s state news agency MENA quoted Maj. Gen. Gamal el-Serafy, director of the Armed Forces Medical Department, as saying.

El-Serafy said doctors had already started testing one of the machines, the so-called “Complete Cure Device,” on 80 Hepatitis C patients who were also being treated with medication.

Saturday’s news conference notably dropped any mention of the device as a cure for AIDS, only referring to hepatitis. None of the research involved has been published in a reputable journal.

The original claim in February raised concerns that the military’s offer of seemingly inconceivable future devices would draw Egypt back into a pattern of broken promises by successive rulers who would frequently announce grand initiatives that failed to meet expectations.

Generals working on the project and pro-military media adopted a defensive stance over the matter, insisting that the inventions would be released to the public and that any criticism of them was part of a foreign plot to rob Egypt of a major scientific victory.

El-Serafy said the armed forces will set up a medical center to treat the viruses in the Suez Canal province of Ismailia to carry out the tests and declare results.

Copyright 2014 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Source:

www.washingtonpost.com

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FDA approves inhaled form of insulin

WASHINGTON (AP) - The Food and Drug Administration has approved a long-delayed inhalable diabetes medication to help patients control their blood sugar levels during meals.

The FDA cleared MannKind Corp.'s Afrezza, a fast-acting form of insulin, for adults with the most common form of diabetes, which affects more than 25 million Americans. Friday's approval comes more than three years after the agency first asked MannKind to run additional clinical studies on the drug.

Demand for diabetes treatments is surging globally as the prevalence of obesity explodes. According to the World Health Organization, roughly 347 million people worldwide have the disease, a chronic condition in which the body either does not make enough insulin to break down the sugar in foods or uses insulin inefficiently. It can lead to blindness, strokes, heart disease or death. In type 2 diabetes, the most common form of the disease, the body does not use insulin properly. Type 1 diabetes is usually diagnosed in children and young adults. In those cases, the body does not produce insulin.

Afrezza, an insulin powder, comes in a single-use cartridge and is designed to be inhaled at the start of a meal or within 20 minutes. MannKind has said that patients using the drug can achieve peak insulin levels within 12 to 15 minutes. That compares to a wait time of an hour and a half or more after patients inject insulin.

The FDA said in its approval announcement that Afrezza is not a substitute for long-acting insulin and is a new option for controlling insulin levels during meals. The agency approved Afrezza with a boxed warning - the strongest type - indicating that the drug should not be used in patients with chronic lung diseases, such as asthma and smoker's cough, due to reports of breathing spasms. The agency is also requiring several follow-up studies looking at the drug's long-term safety, including its impact on the heart and lungs.

Mannkind first submitted the drug to FDA in March 2009. The Valencia, California-based company has no other products on the market and lost more than $191 million last year.

Several other companies have failed to make inhaled insulin work commercially. In 2007, Pfizer Inc. discontinued its inhaled insulin Exubera after it failed to gain ground on the market. In 2008, Eli Lilly & Co. ended its development program, citing regulatory uncertainty.

MannKind shares fell 5.5 percent in regular trading after the FDA's approval announcement but rebounded 70 cents, or 7 percent, to $10.70 in after-hours trading Friday.

Source:

www.usatoday.com

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Low-Dose Aspirin could Reduce Risk of Developing pancreatic Cancer

A novel study by the Yale School of Public Health unveiled that low doses of aspirin can reduce the risk of developing pancreatic cancer.

Researchers assessed medical records of 1,052 patients for which data was collected from 2005 to 2009. Out of them, 362 were found to be having pancreatic cancer and others did not have the condition.

In the next step, researchers compared aspirinuse of patients and risk of cancer. Researchers noticed those patients who have taken low-dose aspirin for six years or less than that had a 39% reduced risk of developed pancreatic cancer.Patients who took low-dose aspirin for over 10 years had a 60% reduction in the risk of pancreatic cancer. As per researchers, low-dose of aspirin was between 75 and 325 milligrams.

"We found that the use of low-dose aspirin was associated with cutting the risk of pancreatic cancer in half, with some evidence that the longer low-dose aspirin was used, the lower the risk", said Harvey A. Risch, Professor of epidemiology in the Department of Chronic Disease Epidemiology at the Yale School of Public Health in New Haven.

It is vital to find ways to prevent the cancer as around one in 60 adults will get diagnosed with pancreatic cancer and five-year survival rate is less than 5%. LaPook explained aspirin disturbs the inflammatory pathway in the body.

If the pathways that can lead to cancer are interrupted, then the risk for cancer gets lowered. LaPook said they are not completely sure on this, but that is their thought.

People with family history of pancreatic cancer or who have other risk factors for the disease could be at benefit if they take low-dose aspirin, suggest researchers. But they should discuss it with their doctors and then start the medication.

Source:

uncovercalifornia.com

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Mankind (MNKD) shares Plunge after FDA Approves Afrezza, inhaled Insulin for Diabetes patients

FDA has approved a new diabetes medication yesterday. The newly approved diabetic drug can be inhaled by the patients. It is reported that the drug which was approved by Food and Drug Administration is Afrezza.

ManKind Corporation is the manufacturer of the drug Afrezza.

Afrezza is a fast acting medicine which can be inhaled. It acts like insulin and helps the patients to maintain blood glucose level.

It is already a known fact that diabetes is a chronic condition in which body is unable to secrete enough insulin to maintain the blood sugar levels.

ManKind’s newly approved Afrezza comes in the form of insulin powder. The manufacturers have suggested that it can be inhaled during meal or just before beginning the meal.

However there is a caution issued by FDA with relation to Mankind’s Afrezza.

The patients who are suffering from pre-existing lung diseases or conditions related to lung diseases like broncholitis, pneumonia or asthma are restricted to use the inhaled diabetic medication. There were reports of breathing spasms among these diabetic patients Mankind (MNKD) shares plunged to 20% during Friday’s trading session after FDA mentioned that the drug Afrezza can’t replace the existing long-term insulin dose and there are some associated risks among the patients related to pulmonary diseases.

Source:

www.wallstreetotc.com

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Numbing medications can harm teething babies, FDA warns

Teething infants can come to serious harm or even death from certain "gum-numbing" medications, according to a new warning from the U.S. Food and Drug Administration.

The agency said Wednesday that local anesthetics known as viscous lidocaine, orbenzocaine-containing teething products, should never be used for teething children, except under the advice and supervision of a health care professional.

Viscous lidocaine contains a local anesthetic in a gel-like syrup. It requires a prescription and is typically used to treat mouth ulcers that can occur in patients undergoing chemotherapy. Parents who happen to have viscous lidocaine on hand may be tempted to use it to help teething babies, but they should not do so, the FDA said in a news release.

There have been reports of teething babies suffering overdoses of viscous lidocaine, according to the Institute for Safe Medication Practices. The FDA noted that in 2014 it received 22 reports of serious incidents, including deaths, tied to use of viscous lidocaine in babies and toddlers under three and a half years of age.

According to the agency, symptoms of overdosing include confusion, jitteriness, shaking, seizures, falling asleep too easily, vision problems and vomiting.

The FDA now requires a warning on the label of all prescription oral viscous lidocaine cautioning against its use in babies and small children for teething pain.

Viscous lidocaine also "can make swallowing difficult and can increase the risk of choking or breathing in food. It can lead to drug toxicity and affect the heart and nervous system," Michael Cohen, ISMP president, said in the FDA news release.

The FDA also said that over-the-counter benzocaine products should not be used for children younger than age 2. These products include Anbesol, Hurricaine, Orajel, Baby Orajel and Orabase.

Benzocaine products for mouth and gum pain can cause a rare but serious and potentially fatal condition called methemoglobinemia, a disorder in which the amount of oxygen carried through the blood stream is greatly reduced. Children under age 2 are at particular risk, the FDA said.

In the end, parents may simply have to accept teething as an uncomfortable but transient part of infancy, experts said.

"Teething is a normal phenomenon; all babies teethe," Dr. Ethan Hausman, a pediatrician and pathologist at the FDA, said in the news release. He added that the agency "does not recommend any sort of drug, herbal or homeopathic medication or therapy for teething in children."

If a child has swollen and tender gums, you can gently massage them with your finger and give the child a cool teething ring or a clean, wet, cool washcloth to chew on, the FDA said.

"The cool object acts like a very mild local anesthetic," Dr. Hari Cheryl Sachs, a pediatrician at the FDA, said in the news release. "This is a great relief for children for a short time."

Source:

www.cbsnews.com

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Summer Feeding program begins Monday for north country children

WATERTOWN — Thousands of meals and snacks are expected to be served throughout the north country this summer as part of the annual federal Summer Feeding Program.

At the Community Action Planning Council of Jefferson County open site, 518 Davidson St., children up to age 18 will receive an added bonus — a new summer recreation program.

“It’s the first time we’ve done something like that,” said Mary J. Mathewson, CAPC’s family center coordinator. “Besides the Salvation Army, there are no recreation sites (in Watertown); they’re just feeding sites.”

Many sites outside of the city are recreation sites, providing crafts and entertainment for children, while CAPC’s site and a few others traditionally have just provided meals and snacks during designated times and days.

Ms. Mathewson said CAPC’s new recreation program will operate from 11 a.m. to 3 p.m. daily, beginning Monday. Evan Higgins has been hired as the Summer Feeding Program activity and site manager.

Parents or guardians must provide transportation for their children to and from the CAPC recreation site. Any child may attend the program, Ms. Mathewson said, regardless of where he or she resides.

“It’s a piece of the puzzle we were missing in the city,” she said. “It’s about the whole experience — the socialization, physical activity and lunch.”

CAPC also oversees a majority of the Summer Feeding Program throughout Jefferson County. Ms. Mathewson said meals and snacks are prepared at the main CAPC site and delivered to the 17 other sites in Jefferson County.

Sites that begin Monday and end Aug. 22 are CAPC; Maywood; Meadowbrook Terrace; Friends Settlement, Philadelphia; Carthage Recreation; Adirondack Creek, Fort Drum; Crescent Woods, Fort Drum; Rhicard Hills, Fort Drum, and Monument Ridge, Fort Drum.

Other sites throughout Jefferson County include Theresa Recreation; Huntington Heights, Watertown; Evans Mills Recreation and Antwerp Recreation, all of which begin July 7 and end Aug. 15. Franklin Street Park, West Carthage, will offer a feeding site from Monday to Aug. 15, and City of Refuge Church, Great Bend, will offer a feeding site from Tuesday to Aug. 22. From July 7 to Aug. 22, the Watertown Salvation Army will offer a feeding site, while Bodman Memorial Library, Philadelphia, will offer a feeding site from Tuesday to Aug. 22. Disabled Persons Action Organization, Watertown, will offer a feeding site from July 7 to Aug. 8.

“The more people that want to do this is a wonderful thing,” Ms. Mathewson said, regarding volunteers.

Throughout the 2013 program, dozens of volunteers helped serve a total 18,999 meals and snacks throughout Jefferson County.

Additional feeding sites, hosted by the Watertown City School District, and open to all children, are from Monday to July 31 at Case Middle School, Monday to Aug. 15 at Knickerbocker Elementary School, Monday to Aug. 29 at the Fairgrounds Y, Tuesday to Aug. 12 at Watertown High School, July 7 to Aug. 1 at Wiley Intermediate School and July 7 to Aug. 15 at the Jefferson-Lewis Board of Cooperative Educational Services.

Lyme Central School District, Chaumont, also will offer a meal through the Summer Feeding Program from July 7 to Aug. 14.

In St. Lawrence County, Edwards-Knox Central School District, Russell, will offer meals from July 7 to Aug. 1. All children up to age 18 are invited, and will be given a ticket to put their name on for a chance to win a free Trek bicycle, courtesy of Dannon Yogurt. According to a school district news release, adults may eat with their child for $4 per meal.

Summer Feeding is sponsored by the U.S. Department of Agriculture. According to a news release from U.S. Sen. Kirsten E. Gillibrand, D-N.Y., there are “more than 1.7 million children who receive free or reduced school lunch, but only 27 percent have access to summer meals.”

For more information, call Ms. Mathewson at 782-4900, ext. 233; Watertown City School District food service director Craig P. Orvis at 785-3717; Lyme Central School District at 649-2417, or Edwards-Knox Central School District cook manager Kathleen Whitmarsh at 562-8130, ext. 1507.

Source:

www.watertowndailytimes.com

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Watching TV for three or more hours everyday can cause premature death, says study

If you watch television for three hours or more everyday, you may die prematurely.

A new study by the American Heart Association conducted a study on 13,284 young Spanish university graduates to find out the link between three kinds of stationary behaviour abd risk of death: computer accessing, watching television and viewing television, Xinhua reported.

Shockingly, the result found that those viewing TV for three or more hours were twice risky than those who watched for merely one or less hours.

However, the scientists were unable to find any connection between premature death and other activities like accessing the computer or driving.

The researchers said more studies will be needed to ascertain what influences may be connected to computer usage and driving on mortality rates.

It is also important to study the biological mechanisms involved in such cases.

(With IANS inputs)

Source:

indiatoday.intoday.in

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FDA Panel Recommends Waiting for Data Before Olaparib Decision

• An FDA advisory panel on Wednesday recommended that the agency require AstraZeneca to gather more data about olaparib’s benefit for patients before deciding on an application filed earlier this year—threatening to derail the accelerated approval sought by the pharma giant for the ovarian cancer candidate.

  FDA's Oncologic Drugs Advisory Committee (ODAC) voted 11–2 to recommend that the agency postpone a decision on approving olaparib until AstraZeneca can present results next year from the Phase III SOLO-2 trial. The FDA is not bound by the committee’s recommendation, but typically follows the advice of its advisory panels.

  SOLO-2 is designed to assess efficacy of olaparib as a maintenance monotherapy in relapsed germline BRCA mutation (gBRCAm) high-grade serous ovarian cancer (HGSOC) patients (including patients with primary peritoneal and/or fallopian tube cancer) or high-grade endometrioid cancer who have responded following platinum-based chemotherapy. SOLO-2’s primary endpoint is progression-free survival (PFS) by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, with overall survival (OS) a secondary endpoint.

  AstraZeneca has cited an analysis of results from a single Phase II trial (“Study 19”) showing an 83% reduction in the risk of progression or death—as well as a seven-month median improvement in maintenance PFS for a subgroup patients who had the BRCA mutation. The analysis identified 51% of Study 19 patients (136) with either a germline or somatic tumor BRCA mutation. Median PFS in patients with the mutation was 11.2 months vs. 4.1 months with placebo.

  The further look followed a 2012 interim analysis of Study 19’s 265 patients with platinum-sensitive ovarian cancer. The interim analysis showed a closer variance in median PFS—8.4 months with olaparib, 4.8 months with placebo.

  But a staff report prepared for ODAC questioned the size of the reanalysis study sample and whether the results looked better because the control arm underperformed. The report also cited concerns about the risk of myelodysplastic syndrome/acute myeloid leukemia and the side effects reported by patients in Study 19, such as nausea, fatigue, vomiting, and anemia.

  "There are uncertainties related to the validity and the reproducibility of the magnitude of effect seen in [the study], and there are risks associated with olaparib therapy,” the staff report concluded.

  Olaparib is an oral inhibitor of polyadenosine 5'-diphosphoribose polymerases (PARP). AstraZeneca filed its NDA for olaparib approval in February. Three months later, FDA granted the company a six-month priority review rather than the standard 10-month review, and set October 3 as its Prescription Drug User Fee Act (PDUFA) target date for a decision.

  Solo-2 is unlikely to produce first results before 2015; the trial is set to conclude in 2016. AstraZeneca is counting on olaoparib to deliver as much as a projected $2 billion in annual sales—and help rebuild its pipeline in oncology, one of the company’s three core therapeutic areas.

  AstraZeneca revived olaparib shortly after current CEO Pascal Soriot took office in 2012. A year earlier, Soriot’s predecessor David Brennan suspended development of the compound, following a failed clinical study. Soriot and executives opted for the retrospective analysis, and tried last year but failed to win a breakthrough drug designation from the FDA.

  The ODAC recommendation is likely to raise more questions about the value of AstraZeneca’s pipeline compounds just weeks after the company beat back several takeover offers from Pfizer, the last of which was for £69 billion ($117.2 billion) before throwing in the towel last month.

  Earlier this month, during the American Society of Clinical Oncology (ASCO) annual meeting in Chicago, AstraZeneca trumpeted positive Phase II results of olaparib with cediranib in patients with platinum-sensitive high-grade serous ovarian cancer. The combination—which in the study nearly doubled the progression-free survival of patients—“has the potential to replace chemotherapy,” Briggs Morrison, AstraZeneca’s evp and CMO, said in a June 3 press release. 
• Source:
• www.genengnews.com

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