Genetic Testing Scam Targets Medicare Beneficiaries.

Genetic Testing Scam Targets Medicare Beneficiaries.
The U.S. Department of Health and Human Services Office of Inspector General is alerting the public about a fraud scheme involving genetic testing.
Scammers are offering Medicare beneficiaries cheek swabs for genetic testing to obtain their Medicare information for identity theft or fraudulent billing purposes. Fraudsters are targeting beneficiaries through telemarketing calls, booths at public events, health fairs, and door-to-door visits.
If a beneficiary agrees to genetic testing or verifies personal or Medicare information, a testing kit is sent even if it is not ordered by a physician or medically necessary.

Protect Yourself

• If a genetic testing kit is mailed to you, don't accept it unless it was ordered by your physician. Refuse the delivery or return it to the sender. Keep a record of the sender's name and the date you returned the items.
• Be suspicious of anyone who offers you free genetic testing and then requests your Medicare number. If your personal information is compromised, it may be used in other fraud schemes.
• A physician that you know and trust should approve any requests for genetic testing.
• Medicare beneficiaries should be cautious of unsolicited requests for their Medicare numbers. If anyone other than your physician's office requests your Medicare information, do not provide it.
• If you suspect Medicare fraud, contact the HHS OIG Hotline.

Summer, Sunglasses, UVB and UVA, Protect your eyes.

Tips for choosing sunglasses

For most people, a low-cost pair of sunglasses with UVB and UVA protection will do the job.
Follow these safety tips when choosing sunglasses to reduce your risk:

• Choose close-fitting wrap around eyewear. Close-fitting or wrap-around sunglasses helps to prevent stray light from entering from the sides.
• Choose dark lenses. Make sure the lenses are dark enough to keep your eyes comfortable, but not so dark that they reduce your vision.
• Reduce glare. If you spend a lot of time outdoors with intense glare from sunlight bouncing off snow or water, you should wear sunglasses that block blue light. Medium to dark lenses with a grey, or slightly brown or green tint, will filter out most blue light.
• Choose scratch-resistant coatings. Most sunglasses have plastic lenses. These lenses are tougher than glass and less likely to shatter. If you buy plastic lenses, look for a pair with a scratch-resistant coating.
• Check for distortion. Check the lenses for distortion by putting the sunglasses on and looking at a rectangular pattern, such as floor tiles. If the lines stay straight when you move your head up and down, and side-to-side, then the amount of distortion is acceptable.
• Get enough UV protection. You cannot tell how much UV protection a pair of sunglasses will provide by their price, colour, or by the darkness of the lenses. Look for a label with UVB and UVA protection.

Amount of UV protection

Manufacturers follow voluntary industry standards when labelling sunglasses. Sunglasses that comply with industry standards for UV protection are grouped in three categories:

• Cosmetic sunglasses have lightly tinted lenses for use in sunlight that is not harsh. They block up to 60 percent of visible light and UVA rays, and between 87.5 and 95 percent of UVB rays. These glasses are not usually recommended for daylight driving.
• General purpose sunglasses block from 60 to 92 percent of visible light and UVA rays, and between 95 and 99 percent of UVB rays. These sunglasses are good for driving, and are recommended whenever sunlight is harsh enough to make you squint.
• Special purpose sunglasses block up to 97 percent of visible light and up to 98.5 percent of UVA rays. They also block at least 99 percent of UVB rays, and are suitable for prolonged sun exposure. These sunglasses are not recommended for driving.
• Contact lenses, even those with UV protection, does not provide full coverage for the eyes and the skin around the eyes.

Types of lenses

Sunglasses are made with different kinds of lenses to meet different needs:

• Regular lenses reduce the brightness of everything evenly.
• Polarizing lenses are designed to cut glare due to reflection. This means they are good for driving and outdoor activities in the snow or on water.
• Photochromic lenses change with the intensity of UV light by turning darker when outdoors and lighter when indoors. If you wear these for driving, choose sunglasses that are fairly dark.
• "Flash" or mirror lenses reflect all or part of the light instead of absorbing it. They offer no performance advantage because they scratch easily. You should choose a pair with a scratch-resistant coating.

About ultraviolet radiation and visible light

The sun produces many different kinds of energy. The kinds most likely to injure the eye are:

• ultraviolet radiation, which is invisible and is often called "UV rays"
• bright or intense light
• blue light

UV rays carry more energy than visible light rays, so the eye is at greater risk of damage from absorbing UV rays than from absorbing other kinds of light. There are two types of UV rays that reach the Earth's surface: UVA and UVB. These rays can cause, or speed up the progress of, several diseases that affect the eye or its supporting structures. UVB rays have also been linked to skin cancer.
Most of the damage caused to eyes by UVB and UVA rays happens over a long period of time and cannot be reversed. Sensitivity to UV rays varies from one person to the next.
Blue light is visible light in the blue portion of the colour spectrum. The intense glare of light reflecting off snow or water contains blue light. Your eyes cannot focus clearly in blue light. Some scientists believe that routine exposure to blue light over many years may age the retina and increase the risk of blindness in some people over the age of sixty.

How the sun can damage your eyes

When your eyes absorb ultraviolet radiation and visible light from the sun, heat or chemicals react in eye tissue. These reactions can cause permanent damage if the eye's natural ability to heal itself is overwhelmed.
Different parts of the eye absorb different kinds of UV rays and visible light. For example:

• The surface layers of the outer part of the eyeball (the cornea and the conjunctiva) absorb UVB rays.
• The lens absorbs mainly UVA rays.
• The retina (the light-sensitive lining at the back of the inner eyeball) absorbs visible light.

If eyes are overexposed to UV radiation, the front portion of the eyes can be damaged. If visible light is too bright or intense, or if you stare directly at the sun, even briefly, the retina can be damaged, causing permanent loss of vision. UV radiation, along with wind and drying of the eye, may cause snow blindness, an uncomfortable but temporary condition.
There is some evidence that daily exposure to UV radiation in very bright sunlight over many years may increase the risk of developing cataracts. Cataracts cause a gradual clouding of the natural lens of the eye.
Thank you Health Canada!

Migrant Health and the right to health. -- 2nd Global Consultation on Migrant Health

Coordinated efforts, and coherent and comprehensive responses with whole-of-government and whole-of-society approaches based on shared values, evidence and multisectoral policy dialogues are required to address the health needs of refugees and migrants. In this regard, WHO jointly organized the 2nd Global Consultation on Migrant Health with the International Organization for Migration (IOM) on 21 - 23 February 2017, in Colombo, Sri Lanka. The consultation was hosted by the Government of the Democratic Socialist Republic of Sri Lanka. More than 90 participants from governments, United Nations bodies, academia, researchers, non-governmental organizations and other multi-sectoral partners participated in the consultation.

More people are on the move now than ever before. There are an estimated 1 billion migrants in the world today of whom 258 million are international migrants and 763 million internal migrants – one in seven of the world’s population. 68 million of the world’s internal and international migrants are forcibly displaced today. This rapid increase of population movement has important public health implications, and therefore requires an adequate response from the health sector.

The right of everyone to enjoy the highest attainable standard of physical and mental health is established in the WHO Constitution of 1948. Ratified international human rights standards and conventions exist to protect the rights of migrants and refugees, including their right to health. Nevertheless, many refugees and migrants often lack access to health services and financial protection for health.

Valisure Finds Another Carcinogen in Blood Pressure Medicine Valsartan, dimethylformamide (DMF)

The most used blood pressure medicine Valsartan, seem to attract troubles like a magnet does iron particles. The newest trouble is a solvent called dimethylformamide or commonly known as DMF, is classified by the World Health Organization as a probable carcinogen. The FDA allows drugs to contain the equivalent of about 8.8 million nanograms of daily exposure to DMF. The agency last revised its allowable solvent levels in 2017; the WHO classified DMF as a probable carcinogen in 2018.

A solvent called dimethylformamide was discovered in the drug valsartan made by several companies, including Swiss pharmaceutical giant Novartis AG, and some companies that were deemed safe by FDA after the recent recalls of valsartan, according to a filing last week to the Food and Drug Administration by New Haven, Connecticut-based Valisure.
Valisure runs an FDA registered facility and its results were verified by Emery Pharma, an FDA-registered research lab in Alameda, California.

“Medicines are kind of like used cars: By the time you get it it’s already five or six years old, it’s touched hundreds of hands and it’s got 100,000 miles on it,” Valisure Chief Executive Officer David Light said in an interview.

Once facts were revealed, none denied the possibility of contamination. Some drugmakers whose pills tested positive for DMF said that neither they nor the outside companies that produce active ingredients for their drugs use the solvent, though some indicated they don’t have complete visibility into their supply chain. Some of the valsartan that was positive for DMF was on a list of medicines the FDA had earlier deemed safe to use amid the recalls, including drugs manufactured by Alembic Pharmaceuticals Ltd. and Macleods Pharmaceuticals Ltd., both based in India.

Alembic doesn’t use DMF in its manufacturing process, according to spokesman Ajay Desai, who said the contamination likely occurred during analysis. A representative for Macleods couldn’t be reached for comment.

“Novartis cannot currently fully exclude the possibility that traces of DMF (within acceptable limits) may have been present in materials” provided to their suppliers, said Novartis spokesman Eric Althoff in an email.

FDA is investigating the Valisure report at the moment. In the meantime these Valsartan had the highest levels of DMF;







Read more at Bloomberg

FDA approves liraglutide (Victoza, Novo Nordisk), new non insulin treatment for pediatric patients with type 2 diabetes

The US Food and Drug Administration, extended the indication for the glucose-lowering drug liraglutide (Victoza, Novo Nordisk) to include pediatric patients, as young as 10 years of age, making it the first non insulin drug approved for treating pediatric type 2 diabetes in almost 20 years.

“The FDA encourages drugs to be made available to the widest number of patients possible when there is evidence of safety and efficacy, Victoza has now been shown to improve blood sugar control in pediatric patients with type 2 diabetes. The expanded indication provides an additional treatment option at a time when an increasing number of children are being diagnosed with this disease.” said Lisa Yanoff, M.D, acting director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research.

Press Release ;

FDA approves new treatment for pediatric patients with type 2 diabetes

The U.S. Food and Drug Administration today approved Victoza (liraglutide) injection for treatment of pediatric patients 10 years or older with type 2 diabetes. Victoza is the first non-insulin drug approved to treat type 2 diabetes in pediatric patients since metformin was approved for pediatric use in 2000. Victoza has been approved to treat adult patients with type 2 diabetes since 2010.
“The FDA encourages drugs to be made available to the widest number of patients possible when there is evidence of safety and efficacy,” said Lisa Yanoff, M.D, acting director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “Victoza has now been shown to improve blood sugar control in pediatric patients with type 2 diabetes. The expanded indication provides an additional treatment option at a time when an increasing number of children are being diagnosed with this disease.”
Type 2 diabetes is the most common form of diabetes, occurring when the pancreas cannot make enough insulin to keep blood sugar at normal levels. Although type 2 diabetes primarily occurs in patients over the age of 45, the prevalence rate among younger patients has been rising dramatically over the past couple of decades. The Diabetes Report Card published by the U.S. Centers for Disease Control and Prevention estimates that more than 5,000 new cases of type 2 diabetes are diagnosed each year among U.S. youth younger than age 20.
Victoza improves blood sugar levels by creating the same effects in the body as the glucagon-like peptide (GLP-1) receptor protein in the pancreas. GLP-1 is often found in insufficient levels in type 2 diabetes patients. Like GLP-1, Victoza slows digestion, prevents the liver from making too much glucose (a simple sugar), and helps the pancreas produce more insulin when needed. As noted on the label, Victoza is not a substitute for insulin and is not indicated for patients with type 1 diabetes or those with diabetic ketoacidosis, a condition associated with diabetes where the body breaks down fat too quickly because there is inadequate insulin or none at all. Victoza is also indicated to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease; however, its effect on major adverse cardiovascular events in pediatrics was not studied and it is not indicated for this use in children.
The efficacy and safety of Victoza for reducing blood sugar in patients with type 2 diabetes was studied in several placebo-controlled trials in adults and one placebo-controlled trial with 134 pediatric patients 10 years and older for more than 26 weeks. Approximately 64% of patients in the pediatric study had a reduction in their hemoglobin A1c (HbA1c) below 7% while on Victoza, compared to only 37% who achieved these results with the placebo. HbA1c is a blood test that is routinely performed to evaluate how well a patient’s diabetes is controlled, and a lower number indicates better control of the disease. These results occurred regardless of whether the patient also took insulin at the same time. Adult patients who took Victoza with insulin or other drugs that increase the amount of insulin the body makes (e.g., sulfonylurea) may have an increased risk of hypoglycemia (low blood sugar). Meanwhile, pediatric patients 10 years and older taking Victoza had a higher risk of hypoglycemia regardless of whether they took other therapies for diabetes.
The prescribing information for Victoza includes a Boxed Warning to advise health care professionals and patients about the increased risk of thyroid C-cell tumors. For this reason, patients who have had, or have family members who have ever had medullary thyroid carcinoma (MTC) should not use Victoza, nor should patients who have an endocrine system condition called multiple endocrine neoplasia syndrome type 2 (MEN 2). In addition, people who have a prior serious hypersensitivity reaction to Victoza or any of the product components should not use Victoza. Victoza also carries warnings about pancreatitis, Victoza pen sharing, hypoglycemia when used in conjunction with certain other drugs known to cause hypoglycemia including insulin and sulfonylurea, renal impairment or kidney failure, hypersensitivity and acute gallbladder disease. The most common side effects are nausea, diarrhea, vomiting, decreased appetite, indigestion and constipation.
The FDA granted this application Priority Review. The approval of Victoza was granted to Novo Nordisk.
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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