Carbon Monoxide – An Often Silent Killer

Carbon monoxide (CO) poisoning causes more than 20,000 emergency room visits and 400 deaths each year in the U.S., according to the Centers for Disease Control and Prevention. It is a colorless, odorless, tasteless gas, making it difficult to detect and therefore difficult to prove as the culprit in countless CO poisoning cases. Many injuries and deaths can be avoided if proper precautions are taken, such as installing CO detectors and designing products to minimize the risk of CO exposure. Despite CO’s deadly effects, it seems the government has done little to recognize the issue as a serious one,  while the automobile and manufacturing industries have barely acted to fix the problem at all.

Sources and Effects of CO Poisoning

The matter of CO poisoning warrants greater attention and awareness, especially after being responsible for so many deaths, like the deaths of Rodney Eric Todd and his seven children. They were all killed from accidental CO poisoning. The carbon monoxide was leaking from a gas generator inside the house that ran out of fuel but was still turned on. While this sounds like an improbable way for eight people to die, CO is known as the silent killer. Perhaps if there were clearer warnings about the dangers of keeping gas generators inside, Todd’s family would still be alive.

Carbon monoxide is a byproduct of many different products such as fuel-burning cars, household appliances, and business operations making CO poisoning possible from many different sources. The estimated annual societal cost of this poisoning is about 1.3 billion dollars based on the medical expenses and lost wages of those affected. Since the compound is commonplace, greater awareness of its effects would decrease the social burden and inadvertent deaths.

Oftentimes it can be difficult to recognize CO poisoning for its flu-like symptoms. Doctors are susceptible to misdiagnosing and improperly treating patients. Symptoms can include headache, dizziness, chest pain, vomiting, and confusion, and even loss of consciousness. One of the most commonly reported conditions is brain damage, caused by the deprivation of oxygen to the tissue and brain as CO binds to hemoglobin in the blood and spreads through the body. There is no cure for CO-related brain injuries, however there are several ways to treat patients. Treatments include cognitive and vocational rehabilitation and hyperbaric oxygen therapy, which is breathing pure oxygen in a chamber with higher-than-normal air pressure. The latter is typically used for severe cases of CO poisoning; it replaces the CO in your bloodstream faster than simply breathing fresh air. The severity of the symptoms depends on the duration of exposure, level of CO, and height and weight of the individual.

CO Poisoning Cases Are Complicated

CO poisoning

Hyperbaric oxygen chambers like this one are sometimes used to treat victims of severe carbon monoxide poisoning.

The wide range of CO sources and the many variables that can affect CO poisoning provides a challenge to the plaintiffs in these cases because they need to prove the source of the CO, establish the cause of harmful exposure, and demonstrate the medical connection between the exposure and injuries. To gather this evidence, many types of expert analyses may be necessary, such as physicians, engineers, medical experts, and a variety of others. A different set of experts are needed to substantiate the effects CO has on the body, including cardiologists, neurologists, toxicologists, and others. Proving damages from CO poisoning is expensive for plaintiffs and results in some difficult obstacles. Another pitfall of these cases are negligence claims based on failure to install a CO detector alarm in the first place. These alarms are an easy way to prevent injury from CO. Unfortunately, CO alarms are only mandated in private domiciles by twenty-seven states via state statute and only five states require them in school buildings. More state laws requiring installation of CO alarms would help to reduce the number of CO poisoning cases.

The type of defendant also changes the way CO poisoning cases are handled. Defendants can range from property owners to hotels and restaurants to appliance repair providers. In the case of property owners, it is vital that they complete preventative maintenance and inspections to determine possible hazards before they occur. If they do not do this, it can constitute a breach of applicable duty of care. There are also various codes that apply in different situations, such as International Fire Codes, International Building Codes, and International Mechanical Codes, as well as standards such as the American National Standards. All of these codes add different layers to defending CO poisoning cases.

Determining the amount of CO in the air that is permissible can also be a contentious issue that often impedes litigation. Governmental agencies and associations have differing opinions. For example, the Occupational Safety Health Administration sets the exposure limit for the workplace at fifty parts per million as a time-weighted-average over an eight-hour period. The recommended exposure limit from the National Institute for Occupational Safety and Health is thirty-five parts per million as a time-weighted average over an eight-hour period. In living spaces, the permissible exposure limit is nine parts per million with the desired level to be zero according to the American Society of Heating, Refrigerating, and Air Conditioning Engineers. These varying numbers suggests that the amount of CO in the air can vary on a case-by-case basis, although the ideal rate is zero parts per million.

Proliferation of Keyless Ignitions in Automobile Industry Presents New Challenges

There are separate challenges presented by keyless ignition cases, which are an excellent example of the automobile industry’s lack of recognition on the issue of CO poisoning. While push-to-start features and smart keys are a technological advantage, they can lead to cars being unintentionally left on after the driver leaves the vehicle. The longer the car is left on, the more harmful exhaust full of CO is released, which can then travel from the garage into the house and harm unsuspecting families, especially if the car is left on overnight. These cars are designed to start when the key fob is nearby, however the fob can be taken away and the car will remain on. While this is a safety problem, automakers have failed to publicize this problem and will continue to promote these cars because the National Highway Traffic Safety Administration is not acting.

All of the above-mentioned complications of CO poisoning result in costly and complex litigation. Each case entails a unique set of requirements and must be approached with individual manner. More accidental deaths will continue to happen, and they will require more persistent advocates to get the attention and care their cases require unless awareness of CO poisoning is more widely spread.

Toxic Chemicals Still Found in Many Common Cosmetics

The U.S. Food and Drug Administration’s (FDA) slow and retroactive response to toxic chemicals found in cosmetics is being called into question. In the past year, there have been more protests urging the FDA to ban lead acetate, a compound found in hair dyes. It was banned in Canada and Europe nearly a decade ago for causing toxic levels of lead to build up in the blood, so what is taking the U.S. so long? Part of the reason why harmful chemicals aren’t banned from cosmetic products faster is that the FDA can only regulate products if it receives “reliable information,” as stated in the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act. Public protests, such as the petitions against lead acetate, are the beginning of the process that incites the FDA to begin research of the chemical, but this research can take years to complete. It is the responsibility of the FDA to find evidence that a certain product is harmful when used as intended because the manufacturer of the product is not required to submit their data. The research necessary to find such evidence takes time to complete. In the meantime, these dangerous chemicals will already have continued to harm many people.

Cosmetic Industry Also at Fault

The FDA’s response to toxic chemicals in cosmetics is not the only issue; there is no regulation of chemicals before the cosmetic products go to market. A company does not have to perform particular tests on products containing new chemicals, nor is it mandatory for the companies to publicize safety data they collect. Lack of accountability has allowed cosmetic manufacturers to use chemicals in everyday items, such as shampoo and toothpaste. Some cosmetics can contain formaldehyde, a byproduct of some preservatives put into cosmetics. The chemical is commonly used as a preservative for dead animal parts, such as the frog you may have dissected in science class. Formaldehyde was declared a human carcinogen by the National Toxicology Program at the Department of Human Health and Services in 2011 because it can cause cancers of the nasal cavity, myeloid leukemia, and rare cancers. About one fifth of cosmetics contain formaldehyde, a scarily high percentage.

Preventative Measures Are Ready For Congressional Passage

toxic chemicals cosmetics

Henri de Toulouse-Lautrec’s “Woman at her toilette”

Consumers should not have to worry about using cosmetics which may have toxic effects on their bodies. One preventive measure the U.S. could enact is to ban chemicals based on preliminary toxicity data rather than the exhaustive data and research that is required. The Personal Care Products Safety Act is a piece of legislation recently introduced in Congress by Senator Dianne Feinstein which may help solve the problem. If passed, the bill will give the FDA the authority to take products off of store shelves immediately after receiving any reports of customers experiencing bad reactions. This will help close the gap between initial complaints and the years it takes the FDA to gather information before banning the chemical. Furthermore, the bill includes the mandate that manufacturers register their facilities and pay a fee to the FDA. The money will be used to determine the safety of at least five cosmetic ingredients a year. This preventative measure will help eliminate the inefficient process of removing harmful products from store shelves after they have gone to market.

While passage of this bill would be an excellent start to solving the problem, the FDA must enforce more thorough regulation of cosmetic products all around. Unfortunately, the laws on regulation of cosmetics do not require FDA approval before being put on the market, apart from color additives. The administration advises the manufacturers to consult available toxicological test data and perform any additional tests necessary to ensure the safety of the product. However the FDA has no legal jurisdiction to ban a product unless a law has been broken, such as the misbranding of a product. Implementing stricter regulations on companies will bring more peace of mind to consumers who should not have to worry about the toxicity of their cosmetics in the first place.

Big Pharma Should Take Reporting Adverse Events to FDA More Seriously

 

FDA

The FDA is the United States’ regulatory agency responsible for dealing with the regulation and supervision of various products affecting human health.

The U.S. Food and Drug Administration’s requirement that pharmaceutical companies report dangerous side effects cause by medicines they manufacture is being flouted by a few bad actors. Such violations of the federal law are rare, fortunately, but the fact that some are failing to follow it can spell danger for consumers.

FDA System That Lists Drugs’ Side Effects Can Save Lives

The Adverse Event Reporting System managed by the FDA aims to protect consumers by disclosing a comprehensive list of side effects caused by marketed prescriptions that have been approved. When a company learns, for example, that the Essure birth-control device has led to instances of abdominal perforation, pelvic pain and severe rashes, it is incumbent upon officials to alert the agency, which then can add to, alter or amend the warning label. Without such crucial information, accidents, injuries and death can result from taking products intended to improve health.

The FDA recently called out Heritage Pharmaceuticals, which describes itself as a provider of “high quality generic medicines that help patients and practitioners achieve affordable healthcare solutions,” for disregarding its duties 10 times. The Eatontown, N.J., company was cited for failure to report adverse events and failure to develop proper procedures for receiving, evaluating and reporting adverse events.

ucm171427“Without adequate written procedures, we cannot be assured that you will accurately capture and report important safety information about your drug products to FDA,” states a Nov. 5, 2015, letter addressed to the CEO of Heritage Pharmaceuticals. “Failure to report ADEs (Adverse Drug Experiences) to FDA at the required intervals raises concerns about your firm’s ability to monitor the safety of drug products, as well as the reliability and integrity of the information submitted to FDA.”

Heritage Pharmaceuticals isn’t the only company singled out for noncompliance. Gilead Sciences, a research-and-development outfit that “commercializes innovative medicines in areas of unmet medical need,” and GlaxoSmithKline, whose mission is “to help people to do more, feel better, live longer,” both were named in a Pharmacoepidemiology & Drug Safety analysis. The analysis found each lacked information in key categories when reporting its products’ side effects – the key categories being patient age, patient gender, the date of the adverse event and a medical explanation of the problem.

“By these measures, report completeness from drug manufacturers was poor compared with direct submissions to the agency,” according to the analysis, titled “Completeness of serious adverse drug event reports received by the US Food and Drug Administration in 2014.” “The FDA needs to update reporting requirements and compliance policies to help industry capture better adverse event information from new forms of manufacturer interactions with health professionals and consumers.

New Study Links Bodybuilding Supplements to Testicular Cancer

Many men use bodybuilding supplements before, during, and after workouts to increase the potential for building and keeping muscle, while burning fat. These bodybuilding supplements often contain high levels of caffeine and other various chemicals to keep energy levels high during a tiring workout. Some men find it hard to work out without these supplements. However, it might get a little easier to ditch the supplements now that a new study published in Nature has linked these magical muscle pills to an increased risk of testicular cancer.

426px-Bodybuilding_supplement_high_protein_drink_mix_700gRates of testicular cancer have increased over the past few decades – with many academics pointing to genes and family history as likely risk factors for development of the cancer. However, these factors alone cannot explain the increased rates of this serious form of cancer. From 1975 to 2011 – cases of testicular cancer in men rose from 3.7 to 5.9 for every hundred thousand men. Bodybuilding supplements may explain some of this increase, especially the steroid androstenedione (“andro”), which is currently banned in the United States after a long and illustrious history of buffing up our professional athletes. The chemical drastically increases serum testosterone levels in men – while also increasing estrogen, which may lead to unwanted side effects.

According to the researchers, “The observed relationship was strong… If you used at an earlier age, you had a higher risk. If you used them longer, you had a higher risk. If you used multiple types, you had a higher risk.” The team conducted a series of 900 interviews on 356 men who had been diagnosed with testicular germ cell cancer and 513 cancer-free men. The survey was not focused solely on supplement use either – the researchers asked various questions about activity levels, drinking and smoking habits, family history of cancer, and injuries to the groin. Use of supplements was also defined pretty broadly, and troublingly low compared to how many men use bodybuilding supplements. The standard for use was defined only as consuming one or more supplements a week for at least four weeks in a row or more. The chemical makeup of the supplements was not explored either – which makes the study quite broad. Androstenedione and creatinine were only mentioned as possible ingredients in the supplements the subjects reported taking.

The researchers warned that further large-scale clinical studies would need to be conducted to potentially establish a causal relationship between these bodybuilding supplements and testicular cancer. The link now is simply correlative, which means that the evidence is too scarce to actually show that one factor causes another. Instead, the two variables are only observed to occur together.

Of course, further research into the cancer risk of bodybuilding supplements is not being welcomed by all. The supplement industry, which we have written about for years, collected over $13 billion dollars in sales in 2013. It is still lightly regulated with little safety oversight into what it sells for American consumption. And just recently, “natural supplements” have made the news for containing (or not containing) ingredients other than what had been advertised. Synthetic amphetamines have been found in weight-loss supplements, and strange chemicals similar to Viagra have been found in “performance-enhancing” male supplements. As the above study and our former blogs on the subject point out, you take a roll of the dice each time you pop a supplement from Wal-Mart or GNC. Until the industry is regulated, it may be a good idea to stick to tried and true methods for achieving your goals instead of looking for an “all-natural” shortcut.

Benicar – Studies Show Link Between Benicar and Villous Atrophy

Benicar is prescribed to treat hypertension and contains the active ingredient olmesartan. One side effect of Benicar is villous atrophy. Villous atrophy is a condition which causes some users to be hospitalized for weeks or months as a result of being unable to properly absorb food and water. Furthermore, as a result of not properly absorbing nutrients into the body for months or years, Benicar users can become severely dehydrated and malnourished and often are hospitalized for long periods of time as a result of kidney failure, or hypokalemia. They require IV fluids and nourishment to be fed to them directly into their bloodstream. Unfortunately for the users of Benicar, neither they nor their physicians had any idea of the devastating side effects caused by Benicar.

Blunting of villi commonly seen in villous atrophy (causing malabsorption). Courtesy of Samir at Wikipedia.

Blunting of villi commonly seen in villous atrophy (causing malabsorption). Courtesy of Samir at Wikipedia.

In May 2012, the Mayo Clinic published a study exposing the connection between Benicar and villous atrophy. Dr. Murray, one of the nation’s top experts on treating celiac disease, observed 22 patients who had gastrointestinal symptoms that mimicked celiac disease, but who tested negative on a celiac blood test and did not respond to a gluten-free diet. Dr. Murray reported that that patients who discontinued Benicar saw their severe gastrointestinal symptoms subside. However, when patients resumed Benicar, their severe gastrointestinal symptoms resumed. Dr. Murray advised these 22 patients to discontinue Benicar and within months all 22 patients displayed marked improvements: they all regained weight and they all displayed significant pathological improvements.

In addition, in 2013, Dr. Peter Greene, and other practicing physicians from Columbia University, published another study that identified 16 additional patients in their practice that were; prescribed Benicar and had clear pathological findings of villous atrophy. Dr. Greene found that the most likely cause of villous atrophy was Benicar usage.

Dr. Carbonnel, an epidemiologist, has also published on multiple occasions that Benicar usage in some patients caused severe gastrointestinal side effects. In these studies, Dr. Carbonnel assessed a large number of patients taking Benicar for the risk of severe gastrointestinal malabsorption associated with the patients’ usage of Benicar and other medicines containing olmesartan. He reported that patients who used drugs containing olmesartan for two years or more were nearly 10 times more likely to be hospitalized as a result of gastrointestinal malabsorption as compared to users of other blood pressure medications.

Benicar – The Hidden Dangers

On January 9, 2015, the Department of Justice announced that Daiichi Sankyo, a Japanese corporation who has its United States headquarters in New Jersey, was fined $39 million as a result of violating the False Claims Act by paying kickbacks to physicians to induce them to prescribe drugs manufactured by Daiichi, including Benicar. Benicar is prescribed to treat hypertension and contains the active ingredient olmesartan.

In 2012, according to the Federal Drug Administration, 10.6 million prescriptions for Benicar were distributed to approximately 1.9 million patients. One side effect of olmesartan is villous atrophy. Villous atrophy causes the body not to absorb water and nutrients causing some Benicar users to be hospitalized for weeks or months. Unfortunately for the users of Benicar, neither they nor their physicians had any idea of the devastating side effect caused by Benicar.

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Furthermore, as a result of not properly absorbing nutrient into the body for long periods of time, Benicar users can become severely dehydrated and malnourished resulting in kidney failure, hypovolemia, or hypokalemia. Patients suffering such side effects often will require IV fluids and nourishment administered to them directly into their bloodstream.

Within a few months after the Benicar users discontinue their medication, most will usually begin to absorb nutrients and water normally. However, some Benicar users do not fully recover and suffer permanent injuries.