I was shocked to hear that melamine was found in infant’s milk powder manufactured in China. How can these manufacturers not consider the harm to innocent babies who rely on milk as their only source of nutrition? Not only is this happening in China, the very fact that unscrupulous activities can deceive the public is frightening. Hence, the FDA has taken the right approach not to assume anything. Here’s the latest excerpt from FDA on this matter…..

In a guidance issued 6 Aug 2009, the U.S. Food and Drug Administration says that certain pharmaceutical ingredients used in the manufacture or preparation of drug products should be tested for melamine.

Melamine is a synthetic chemical with a variety of industrial uses including the production of resins and foams, cleaning products, fertilizers and pesticides. If ingested in sufficient amounts, melamine can result in kidney failure and death.

Although the FDA has no reason to believe that the U.S. pharmaceutical supply is contaminated with melamine, recent events involving pet and livestock food products in the United States, and milk products for infants in China, underscore the potential problem.

The guidance is an initial measure by the agency in working with pharmaceutical manufacturers, repackers, other suppliers and pharmacists to conduct melamine testing. The agency invites comments on the guidance, available online and titled “Guidance for Industry: Pharmaceutical Components At Risk for Melamine Contamination“.

“The FDA urges implementation of appropriate controls to assure consumers that melamine contamination will not happen in the pharmaceutical supply chain,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “We look forward to working with industry on this serious public health concern.”

The FDA identifies specific pharmaceutical ingredients in the guidance that are recommended to be screened for the presence of melamine. The guidance also recommends the use of FDA-published methods for this testing that are used to detect the presence of melamine in food proteins. These tests rely on equipment that is generally available to pharmaceutical manufacturers or contract testing labs. The agency also is developing a sampling and testing program for pharmaceutical ingredients at risk for melamine contamination.

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Here’s some shocking news about unsanitary conditions which I would like to share….. here’s what the FDA article on 7 August 2009 states:

At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized tuna salad sandwiches and other food products from Bearden Sandwich Company Inc., doing business as Southern Belle Sandwich Company, in Baton Rouge, La.

The seized products, totaling more than $72,000, violate the Federal Food, Drug, and Cosmetic Act because the products have been prepared, packed, and held under unsanitary conditions whereby they may have become contaminated with filth or rendered injurious to the public’s health (the Act uses the term “insanitary” to describe such conditions). In addition, the tuna fish salad sandwiches were processed under conditions that violate Seafood Hazard Analysis Critical Control Point (HACCP) regulations.

“When FDA investigators find violations inside a company’s facility, we will do what is necessary to keep insanitary and potentially harmful products out of consumers’ hands,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs. “Companies that are not complying with our laws will be subject to enforcement actions.”

Recent FDA inspections found evidence of widespread and active rodent and insect infestation, filthy conditions, and poor employee practices, such as allowing food-processing utensils to lie on the floor near live insects.

The company distributes products to convenience and retail stores in southern Louisiana; Mobile, Ala.; Montgomery, Ala.; and Crestview, Fla.

The FDA has not received reports of illnesses associated with consumption of the products. The FDA urges consumers who may have purchased the products to dispose of them in a safe manner and wash their hands thoroughly after handling the products. “Safe disposal” means avoiding bare-hand contact with the recalled products, discarding them in a way that will not allow people and pets to retrieve them, and washing items that came in contact with the products, including hands, with warm, soapy water.
Consumers can also report problems, including adverse reactions, to the FDA district office consumer complaint coordinator.

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The U.S. FDA has issued an alert on 19 Marc 09 o remind the public that Insulin Pens and Insulin Cartridges Must Not Be Shared.

Originally, this alert was sent to health care professionals reminding them that single-patient insulin pens and insulin cartridges should not be used to administer medication to multiple patients due to the potential risk of transmitting blood-borne pathogens such as HIV and the hepatitis viruses. However, I felt that this is something all diabetic patients should be aware of, so that if it happend to them, they are also well aware of the risks.

What’s the rationale for this alert?
Well, insulin pens are pen-shaped injector devices that contain a disposable needle and either an insulin reservoir or an insulin cartridge. The devices typically contain enough insulin for a patient to self-administer several doses of insulin before the reservoir or cartridge is empty. All insulin pens are approved only for single-patient use (one device for only one patient).

Apparently, the FDA was aware of incidents at two undisclosed hospitals involving more than 2,000 people in which the cartridge component of the insulin pens were used to administer insulin to multiple patients, although the disposable needles were reportedly changed among patients.

“Insulin pens are designed to be safe for one patient to use one pen multiple times with a new, fresh needle for each injection,” said Amy Egan, M.D., deputy director of safety at the FDA’s Division of Metabolism and Endocrinology Products in the Center for Drug Evaluation and Research. “Insulin pens are not designed, and are not safe, for one pen to be used by more than one patient, even if needles are changed between patients due to the risk of transmitting blood-borne pathogens.”

Patients exposed to shared insulin pens are being contacted by the two hospitals and are being offered testing for hepatitis and HIV. Some of the potentially exposed patients have reportedly tested positive for the hepatitis C virus, although it is not known if the virus was spread as a result of insulin pen sharing.

The FDA is working with the Centers for Disease Control and Prevention and professional organizations to address infection control issues related to insulin pens.

For us, as Diabetes patients, please be aware of the risks of sharing insulin catridges. If you see it being done at health care centres, stop the staff immediately and report the incident to the FDA. Also, don’t share the catridges amongst family members. Better safe than sorry!

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Professor Herbert Herzog, Director of the Neuroscience Research Program at

Australia-based Garvan Institute of Medical Research, together with scientists

from the US and Slovakia, have done obesity research which have shown that

neuropeptide Y (NPY), a molecule the body releases when stressed, can

‘unlock’ Y2 receptors in the body’s fat cells, stimulating the cells to grow in

size and number. By blocking those receptors, it may be possible to prevent

fat growth, or make fat cells die.

“We have known for over a decade that there is a connection between chronic

stress and obesity,” said Professor Herzog. “We also know that NPY plays a

major role in other chronic stress-induced conditions, such as susceptibility

to infection. Now we have identified the exact pathway, or chain of molecular

events, that links chronic stress with obesity.”
“There is not much we can do about the increased levels of NPY caused by

stress, but we can do something about the damage it causes. If we can

interfere before it causes fat to amass, it could have a major impact on

cardiovascular disease, diabetes, and cancer (which all have links with

obesity). When we have a stress reaction, NPY levels rise in our bodies,

causing our heart rate and blood pressure to go up, among other things.

Stress reactions are normal, unavoidable, and generally serve a useful

purpose in life. It’s when stress is chronic that its effects become damaging,”

he said.
Scientists at Georgetown University (Washington DC), part of this

collaborative study, have found a direct connection between stress, a high

calorie diet and unexpectedly high weight gain. Stressed and unstressed

mice were fed normal diets and high calorie (high fat and high sugar, or so

called comfort food) diets. The mice on normal diets did not become obese.

However, stressed mice on high calorie diets gained twice as much fat as

unstressed mice on the same diet. The novel and unexpected finding was

that when stressed and non-stressed animals ate the same high calorie

foods, the stressed animals utilized and stored fat differently.
“Our findings suggest that we may be able to reverse or fidn treatments for

obesity caused by stress and diet, including the worst kind of obesity; the

apple-shaped type, which makes people more susceptible to heart disease

and diabetes,” said Professor Zofia Zukowska, the senior author of paper

published in Nature Medicine. “Using animal models, in which we have either

blocked the Y2 receptor, or selectively removed the gene from the abdominal

fat cells, we have shown that stressed mice on high calorie diets do not

become obese. Even more surprisingly, in addition to having flatter bellies,

adverse metabolic changes linked to stress and diet, which include glucose

intolerance and fatty liver, became markedly reduced. We do not know yet

exactly how that happens, but the effect was remarkable,” said Professor

Zukowska.
Professor Herzog believes that these research findings will have a profound

effect on the way society will deal with the obesity epidemic. “There are

millions of people around the world who have lived with high levels of stress for

so long their bodies think it’s ‘normal’. If these people also eat a high fat and

high sugar diet, which is what many do as a way to reduce their stress, they

will become obese. Until now, the pharmaceutical industry has focused on

appetite suppressants with only moderate success. Our hope is that in the

near future pharmaceutical companies, using the results of our research, will

develop antagonists against the Y2 receptor that will bring about a reduction

in fat cells.” . This could be a good approach in finding a treatment for obesity

and the key to obesity prevention.

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It’s official, a low-carb diet is better at burning fat than just cutting calories.

American scientists who were working to find out how diet affects the operation of the liver put 14 overweight people on either a low carbohydrate or low calorie diet.

They found those eating fewer carbs lost almost double the weight over two weeks, and several changes in liver function were identified as part of the reason why.

“Energy production is expensive for the liver,” says Dr Jeffrey Browning, assistant professor at the UT Southwestern Medical Centre, in Dallas, Texas.

“It appears that for the people on a low-carbohydrate diet, in order to meet that expense, their livers have to burn excess fat.”

The average weight loss for the low-calorie dieters was about 2.2kg, while the low-carb dieters lost about 4.3kg on average.

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