Watchdog Report

reuters.com

(Reuters Health) - High levels of benzene, a chemical in crude oil and gasoline, are present in hookah smokers and nonsmokers after they attend social events where the water pipes are used, a new report says.

Benzene exposure is a known risk fac…

Honda underreported 1,729 deaths and injuries By Katie Lobosco and Chris Isidore, cnn.com

Honda failed to report 1,729 serious accidents resulting in injuries or deaths to U.S. safety regulators.

The company knew about the accidents that took place between 2003 and 2014, but blamed data entry and computer programming errors for the…

Clothing contains a surprising amount of toxic chemicals. Did you know that some "non-iron" shirts contain formaldehyde? The amount of cancer causing chemicals we are exposed to daily is staggering! 

Considering that the top two reasons people shy away from vaccinations, or decide they are not right for their family, are vaccine safety and vaccine effectiveness, researchers have been trying to figure out how to fix both these problems. And, according to Medical Xpress research has discovered something that may be a step in the right direction for leery consumers concerning vaccine effectiveness.

Scientists have discovered an important mechanism in which a synthetic DNA targets the immune system that could significantly improve the effectiveness of future vaccines.

Burnet Institute Centre for Immunology Laboratory Head, Dr Irina Caminschi, has identified for the first time a new receptor (DEC-205) that binds to the synthetic DNA (known as CpG), "CpG is very immune-stimulatory, it makes the immune system more reactive, which is why it is used in vaccines. It is currently in clinical trials for cancer and malaria vaccines," Dr Caminschi said.

In recent months a chemical found in several common household products has been on the crosshairs of a number of organizations as they have sought, yet at this point unsuccessfully, to ban a dangerous chemical that has been linked to several adverse health events.

The chemical is Bisphenol A or BPA and it is found in products such as bottled waters, plastic packaging, etc. It is believed that when these plastics degrade, BPA is released into the environment and routinely ingested; therefore causing several adverse health and development effects, from cancer and neurological disorders to physiological defects and, perhaps, even obesity.

But now according to Science Daily, new research suggests the real threat of the chemical comes once it’s broken down in the body and interferes with the endocrine system.

The finding is concerning, considering more than 90% of Americans show exposure to BPA at varying levels. But the finding could also lead to ways to promote health, according to the researchers.

Federal officials believe that as many as 13,000 people have received steroid shots suspected in a national meningitis outbreak, they have recently announced. But, how many are actually in danger? And, how did something like this happen?

Officials say they really don’t know how many are in danger, because they don't know how many of the shots were actually contaminated with the meningitis-causing fungus, and they don’t know as of yet how many actually got them in the back for pain — who are most at risk — but also those who got the shots in other places, like knees and shoulders.

There was no breakdown on the number of back injections, said Curtis Allen, a spokesman for the Centers for Disease Control and Prevention. Those injected in joints are not believed to be at risk for meningitis, he said.

Meningitis is an inflammation of the lining of the brain and spinal cord, and a back injection would put any contaminant in more direct contact with that lining.

Symptoms on meningitis include severe headache, nausea, dizziness and fever. The CDC said many of the cases have been mild and some people had strokes. Symptoms have been appearing between one and four weeks after patients got the shots.

The Centers for Disease Control and Prevention has issued a challenge to physicians concerning the flu vaccine…a challenge for them to do better! They want them to top the 86% vaccination rate they achieved during the previous flu season. And they want them to do better in encouraging their patients to be vaccinated as well.

New Recommendations

Even though the rate at which health care workers are receiving the vaccine right now is better than the entire U.S. public, federal health officials would love to see them do better and recommend that 100% of all health care workers, including physicians and nurses have their vaccine.

And, despite the fact that the majority of the general U.S. public is also recommended to get the shot, according to new statistics, less than half of the population is getting the jab. So, the CDC believes if more doctors would get the vaccine themselves, and then recommend it to their patients, they would see a rise in these numbers.

These recommendations and numbers came in a Sept 27 briefing sponsored by National Foundation for Infectious Diseases in Washington. Data was used from the Morbidity and Mortality Weekly Report, representing 128 million administered flu shots, during the 2011-12 season, which was a slight improvement upon the 123 million vaccines distributed during the previous flu cycle. An estimated 135 million flu vaccines will be produced and made available during the upcoming flu season.

Valium and Xanax, popular anti-anxiety drugs have been linked with an increased risk of dementia in seniors, according to new research.

Patients over the age of 65 who start taking the drugs known as benzodiazepines, and also used to treat insomnia, have a 50% increased chance of developing dementia within 15 years compared with people who had never used the drug, according to the study.

Researchers from the University of Bordeaux, France, warned that "indiscriminate widespread use" of the drugs should be cautioned against.

Benzodiazepine is a widely prescribed drug for seniors in many countries: 30% of this age group in France, 20% in Canada and Spain, 15% in Australia. Although less widespread in the UK and US it is still very widely used and many individuals take this drug for years despite guidelines suggesting it should be limited to a few weeks.

The research examined 1063 people with an average age of 78 over two decades. They had never taken the drug before and were all free from dementia.

As one teenager seeks justice, the Risperdal battle continues this week as sales representatives testify that the company’s top officials did in fact know and even encourage their employees to promote the drug for uses not approved by the U.S. Food and Drug Administration.

One former Janssen Pharmaceuticals sales representative, who was promoted because of his success in selling the antipsychotic drug Risperdal, told a Philadelphia Common Pleas Court jury Monday that he and his team were simply following orders from the top of the company.

"Janssen wanted Risperdal to be a $1 billion drug, and that led to how we would communicate with our customers," said Tone Jones, referring to doctors who would prescribe the drug to patients. Jones was a sales representative for Janssen and Risperdal.

According to The Philadelphia Inquirer, The jury of eight men and four women will decide whether J&J owes money to the family of a 17-year-old from Texas who was prescribed the drug when he was 5 and started growing breasts at age 12. Judge Mark Bernstein told the jury he expected the case to last about three weeks.

Johnson & Johnson, the parent company of Janssen, faces hundreds of individual lawsuits alleging harm to patients, but it also faces -- or has paid to settle -- multiple state and federal cases involving inappropriate promotion of Risperdal.

Medical devicemaker Zimmer Holdings Inc is apparently in trouble with the FDA over manufacturing troubles involving a hip replacement device.

Federal regulators issued the devicemaker a warning letter regarding its Trilogy Acetabular System devices, citing problems over how the product is manufactured and tested at a Ponce, Puerto Rico facility, the company disclosed in a recent regulatory filing. The Sept. 19, 2012 warning letter follows regulator inspection of the plant in June.

Evidently the problem stemmed from a lack of testing, as FDA inspectors were troubled that Zimmer had no testing mechanism to show that Trilogy products matched pre-determined design specifications. Additionally, the FDA noted the absence of quality test manufacturing at the Puerto Rico plant of Trilogy products "that incorporate metallic spikes."

According to a Safety Alert just issued by the FDA, Hospira is initiating a voluntary recall due to the presence of mold within one of their injections, adding to their list of recent problems.

The user-level recall is of one lot of Lactated Ringer’s and 5% Dextrose Injection, USP, 1000 mL, Flexible Container, NDC 0409-7929-09. This action is due to one confirmed customer report where a leak was identified in the primary container between the cobra cap and fill-tube seal and a spore-like structured particulate, consistent with mold, was noted in the solution.

According to the FDA, when a primary container within an overwrap has a leak, there is an open pathway for contamination of the fluid. The overwrap is not sterile, and any fluid which may have leaked out may become trapped within the overwrap and has the potential to be reintroduced into the primary container. If contaminated solution is used on a patient, critical patient harm may result. Injections of mold could potentially lead to septicemia (blood stream infections), which in a worst-case scenario may have the potential to progress to septic shock, which may be life threatening. Signs and symptoms could include injection site reactions, fever, shortness of breath, fast heart rate and feeling generally ill with nausea and vomiting.

The FDA has issued a Safety Alert for a waste management system from medical device giant Stryker Corp stating that the device can cause bleeding as well as soft tissue, muscle and vital organ damage. The alert comes just a week after the company was forced to issue a Class 1 recall on the product.

The recall and alert are a result of two serious injuries, including a death. The device, the Stryker Neptune Waste Management System, is a medical device that has never gained regulatory approval.

According to a Bloomberg report, Stryker was forced to issue a Class I recall on three models of its Neptune Waste Management System after receiving two reports of malfunctions that caused patients serious injury or death. A Class I recall is the most serious recall, which indicates usage of that device is likely to cause serious injuries or death.

The Neptune Waste Management System is used during surgical procedures to collect fluid waste from the patient. The Neptune 2 Ultra can also remove smoke generated at surgical sites by electrocautery or laser devices. Both systems consist of a mobile rover unit that can be relocated to a waste disposal area so the waste collection canisters can be emptied through the device’s docking station.