Meningitis Outbreak Continues to Spread

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More pharmaceuticals have been linked to a meningitis outbreak which has sickened 214 people killed 15.

New England Compounding Center, NECC, is the pharmaceutical company at the center of the outbreak and is cooperating with the FDA and the CDC advising doctors and surgeons to contact patients who have come in contact with drugs which may be responsible for the spread of meningitis.

“All Natural” Isn’t Always What It Seems

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Ingredients labeled “natural” may actually be harmful.

“All-natural geranium extract”, only sounds healthy.
However, according to a new study, it’s anything but natural—and it might even be lethal.

Makers of workout and weight-loss products—think diet pills and sports drinks—containing DMAA (1,3-dimethylamylamine) tout it as a natural stimulant, made from geranium plants, that can boost athletic performance. But new research from Daniel Armstrong, PhD, a professor at the University of Texas at Arlington, finds that DMAA is actually a synthetic substance—one that the FDA has received 42 complaints about regarding adverse effects, such as cardiac and psychiatric disorders, as well as death.

In April 2012, the FDA sent warning letters to 10 manufacturers that products containing DMAA are now considered to be “new dietary ingredients” and must meet FD guidelines for safety.

Even if the manufacturers had submitted safety documentation, the FDA probably wouldn’t have accepted it in light of clear evidence to the contrary.

There have been two deaths of U.S. soldiers reported—as well as multiple reports of kidney and liver failure—which led to the Department of Defense banning anything containing DMAA in military bases in 2012.

FDA Bans BPA From Baby Bottles And Sippy Cups

The FDA has finally publicly recognized the dangers of BPA in plastics and the environment.

The ban is based on concerns voiced by the American Chemistry Council which encouraged the FDA to phase out use of BPA in these particular products.

This was designed in part to counter years of negative publicity from consumer groups.

The dangers of BPA in the environment and their effect on all humans have raised red flags for years.

Previous research in animals has associated BPA exposure to disruptions in reproductive and nervous-system development in babies, but the FDA has long maintained that such findings cannot be applied to humans. Other observational studies in humans have associated prenatal exposure to the chemical with behavior problems and childhood asthma. Just this week, the journal Pediatrics published a study linking BPA in dental fillings to problems like depression and anxiety in kids.

Some 96% of pregnant women have measurable levels of BPA, according to a 2011 study by University of California, San Francisco, researchers; in fact, data show that nearly every American has traces of BPA in their urine from exposure to food and beverage packaging.

For now, the federal government maintains that BPA does not harm humans, but it is spending $30 million on its own studies to assess the chemical’s health effects on humans.

The FDA Has Approved The Diet Drug Qsymia

The FDA has approved Qsymia for use today by those who are obese, with a BMI of 30 or more, or for those who have a BMI of 27 with weight related illness.

The history of weight loss pills has been fraught with law suits due to life threatening side affects and prescription abuse by physicians and patients.

The major problem with weight loss drugs is that they don’t address the underlying causes of weight gain such as the psychological component of over eating and the food itself.

There is wide ranging debate regarding the way certain processed and scientifically engineered foodstuffs react with human physiology and metabolism.

Until we confront these two major issues surrounding food it will be difficult to solve America’s obesity epidemic with a pill.

“Given the literally insatiable appetite of doctors and patients for new drugs as a quick fix for obesity, there is every reason to believe that, if approved, a combination like this, will be used by millions, over long periods of time far beyond its labeling indications. Because of a long list of safety reasons, this drug should not be approved,” the group’s Dr. Sidney Wolfe told the FDA advisory panel in 2010.
Vivus, the company that makes Qsymia, hopes it will be a safer successor to the notorious and now banned “fen-phen” diet cocktail. Fen-phen combined fenfluramine and phentermine — one of the two drugs in Qsymia — but it damaged the heart in some cases and caused a condition in some patients called pulmonary hypertension, which causes fluid to build up in the chest, bringing a feeling of breathlessness.

FDA Scientists Penalized For Voicing Concerns

The FDA used spy software designed to help employers monitor workers and capture screen images from the government laptops used when they working from home.

A detailed surveillance, of the five scientists in question, included monitoring of keystrokes, personal e-mails, documents on personal thumb drives and line by line messages which were captured by the agency.

A dispute lasting years between the scientists and their bosses at the F.D.A. fueled the intense scrutiny of the information.

The scientists’ claims that faulty review procedures at the agency had led to the approval of medical imaging devices for mammograms and colonoscopies that exposed patients to dangerous levels of radiation is at the center of this investigation.

Moving to quell what one memorandum called the “collaboration” of the F.D.A.’s opponents, the surveillance operation identified 21 agency employees, Congressional officials, outside medical researchers and journalists thought to be working together to put out negative and “defamatory” information about the agency.

F.D.A. officials defended the surveillance operation, saying that the computer monitoring was limited to the five scientists suspected of leaking confidential information about the safety and design of medical devices.

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