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]]>Most persons infected with Salmonella develop diarrhea, fever, and abdominal cramps 12–72 hours after infection. Infection is usually diagnosed by culture of a stool sample. The illness usually lasts from 4 to 7 days. Although most people recover without treatment, severe infections may occur. Infants, elderly persons, and those with weakened immune systems are more likely than others to develop severe illness. When severe infection occurs, Salmonella may spread from the intestines to the bloodstream and then to other body sites and can cause death unless the person is treated promptly with antibiotics.
Sources:
Feb. 1, 2010, USDA
CDC Investigation of Multistate Outbreak of Salmonella
The findings are set out in an article in the International Journal of Clinical Practice. The researchers reviewed over 50 studies published since 1995. The data particularly focused on erectile dysfunction medication, and showed the over 44% of these drugs were fake. The consequences were dire for some, including 150 men admitted to hospitals after taking counterfeit tadalafil and herbal preparations that claimed to cure the dysfunction. Seven were comatose and four subsequently died. Two pregnant women died after being given injections of a counterfeit iron preparation for anemia. Fifty-one children died of kidney failure after taking paracetamol syrup contaminated with glycol, an antifreeze used in cars.
We have previously reported on the problem of herbal preparations being spiked with prescription medications here, here, here, here and here.
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We see corporate deceit in many of the cases we handle, so we get hardened to it. Sometimes we see a story, however, that amazes even us. This is one of them. A St. Petersburg, Florida company, Youth Research, had been hired to perform child safety tests on cigarette lighters. It has now been found to have falsified the tests and to have submitted fraudulent reports to federal regulators. The discovery of the fraud has prompted the Consumer Product Safety Commission to order 12 lighters off the market until they have been retested.
The CPSC implemented lighter safety standards after research showed that children under the age of 5 had inadvertently started 5,900 residential fires resulting in 170 deaths and 1,150 injuries in a two-year period. The standards require that panels of 100 children be given dummy lighters to see if they can activate the lighters. A lighter would pass only if 85% of the children could not activate it. In creating the fraudulent test results, the company altered birth dates and identity records and eliminated data that showed that a child could ignite the lighters.
The woman at the center of the fraud, Karen Forcade, has now pleaded guilty to fraud in federal court.
Sources:
St. Petersburg Times, January 23, 2010.
The Tampa Tribune, January 24, 2010
United States of America v. Karen Forcade, U.S. District Court, Middle District of Florida, Case No. 8:09-CR-544-T-27TBM.
As for the safety of these products, the industry has repeatedly picked the pockets of consumers with this magical thinking: "it is all-natural, so it has no side-effects but it works better than drugs." Of course, for a compound to work, it must have an effect, which means it is capable of affecting the body and causing side effects. It can't be effective and affect the body positively but never affect the body negatively. If it can affect the body at all, it is capable of having side effects, period. It is as if they were saying, "yes you can have the money and never pay taxes on it." Yet, we know that the IRS always gets its piece. And, herbals and diet supplements will always tax the body--there are always side effects.
We can't blame the industry, because we let them get away with selling billions of dollars of useless or dangerous or tainted products. We let Congress take money from the industry's lobbyists to pass DSHEA and dodge the effective regulation of the marketing and manufacturing of these products. We let the diet supplement industry tell consumers, "Ego exigo, proinde is est bonus,"...."I sell it, therefore it is good." We do not demand that the marketeers prove their case that a product is safe or efficacious, the simple standard the drug and OTC industries must meet.
Today's news comes to us from the Journal of the American Medical Association reporting on a study of over 3,000 people between 72 and 96 who were followed for over 6 years. None had dementia before the study began. Those who took the supplement fared no better than those who took a sugar pill in tests examining memory, language, attention, and other measures of cognitive function.
With annual sales of gingko biloba of over $250 million dollars, the industry could well afford to pay for its own testing for safety and efficacy. But, instead we paid for the testing with public funds. We let that happen, too.
Sources:
Diet Supplement Glucosamine No Better Than Placebo, February 20, 2008
New York Times, Extra Vitamin E: No Benefit, Maybe Harm, March 24, 2009
New York Times, Vitamin Pills: A False Hope?, February 16, 2009
The FDA has taken the position that generics are equivalent, but the public is not informed about the agency's standard of review: a generic is deemed "bioequivalent" if it achieves 80 to 125% of what the brand-name drug provides. This is a huge variance, and one we don't accept in many human endeavors, whether we are talking about a pilot landing a plane or sending in what we owe to the IRS.
Indeed, specialists acknowledge a growing concern that patient experiences on generics are problematic, especially for those patients who have conditions that present significant risk of injury if chronic conditions are not properly treated, as in epilepsy or atrial fibrillation. For example, The American Academy of Neurology has released a position paper on generics, stating that: “The A.A.N. opposes generic substitution of anticonvulsant drugs for the treatment of epilepsy without the attending physician’s approval.”
If you take medications for a condition that has the risk of significant injury or death if your medications are not effective, you should discuss this concern about generics with your prescribing physician. Become an informed consumer about the generic drug you are being asked to take. And regardless what you are told, pay close attention to your symptoms and changes in your condition after taking generics so that you can determine from your own experience whether a generic drug is right for you.
Sources:
New York Times, Dec. 17, 2009
This decision follows on the heels of the United States Supreme Court's ruling in Wyeth, Inc. v. Levine that the FDA's approval of a drug's label does not provide immunity from suit by federal preemption when name-brand drugs cause injury. The Eighth Circuit's decision in Mensing was the first federal appellate decision since Levine to rule that federal preemption does not immunize generic drug manufacturers from liability.
Please see our earlier discussions about the importance of defeating this preemption doctrine.
3/4/09, 12/15/08, 10/20/08, 9/11/08, 8/15/08, and 7/17/08.
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•More than half of the adult population, about 114 million people, consume dietary supplements.
•The majority of consumers mistakenly believe that dietary supplements are approved by a government agency –- two-thirds of them thought that the government requires that labels on supplements include warnings about their potential side effects or dangers.
•The great majority of the estimated 50,000 adverse events that occur annually remain unreported to the FDA, even though manufacturers have since 2007 been required to report serious supplement-related adverse events to the FDA.
•A recent survey of more than 300 physicians who were residents in internal medicine at fifteen different U.S. training programs showed that one-third of them believed that diet supplements require FDA approval – the majority did not know that adverse events suspected to have been caused by supplements must be reported to the FDA.
The Journal emphasized that a wide range of supplements have been found to be contaminated with toxic plant material, heavy metals, or bacteria. Moreover, dozens of supplements have been found to be intentionally contaminated (“spiked”) with prescription medications, controlled substances, experimental compounds, or drugs already rejected by the FDA for safety concerns. As recently as July 2009, the FDA alerted the public to a list of 75 tainted weight loss products that contained undeclared medications, including the stimulant sibutramine, some at levels three times the maximum recommended daily dose. Others contains rimonabant (linked to suicide) and fenproporex (linked to addiction and suicide). Some weight loss pills, many from Brazil, combine multiple medications in a single formula, substantially increasing the risk of adverse events.
The Journal also explained how unscrupulous manufacturers were attempting to fly below the FDA’s radar by using analogues of pharmaceutical compounds. A recent analysis showed that half of 26 supplements marketed for enhancement of sexual function contained analogues of phosphodiesterase Type 5 inhibitors. Reports from three separate countries establish that the analogue of fenfluramine has been linked to liver damage, including fulminant hepatic failure requiring transplantation.
Most recently, tainted products were found being manufactured by a domestic company, American Cellular Labs, which was manufacturing supplements contaminated with anabolic steroids.
The article closed with the admonition that physicians should maintain a high index of suspicion for supplement-induced adverse effects, even when the component stated on the label are not known to cause the symptoms the patient is suffering. After recognizing that DSHEA presents "serious obstacles to the FDA's ability to detect and eliminate contaminated supplements," it called upon Congress to give the FDA the necessary authority and resources to regulate this industry, the author concluded that, until that regulatory authority was given: “Millions of Americans will continue to be exposed to unacceptable risks in exchange for purported but unproven health benefits.”
Source:
New England Journal of Medicine, Volume 361:1523-1525 October 15, 2009 Number 16
]]>Those are just some of the conclusions contained in a new report just released by the American Association for Justice. Researches analyzed more than a million lines of data obtained from the Federal Motor Carrier Safety Administration (FMCSA). The full report Warning! Safety Violations Ahead may be read here.
When big heavily loaded trucks hit cars, the cars and their occupants usually lose. That's just the law of physics. So consumers have the right to expect trucking companies to be especially vigilant about equipment maintenance and safety. But many needless injuries and deaths are caused because truckers ignore equipment problems. One egregious example is the truckers who fixed a leak in the air brake line with a toothpick and electrical tape. As any thinking person would expect, the "fix" failed after a short time, causing the needless death of a motorist.
The study found that more than 28,000 trucking companies are operating on U.S. roads with safety violations, representing over 200,000 trucks. Truck crashes caused over 12% of all motor vehicle deaths, even though trucks make up only 4% of all vehicles on the road. And that statistic is not a result of trucks covering more miles, because trucks cause deaths per mile driven that are 56% higher than those caused by all vehicles combined.
]]> Many companies are no more concerned with your safety than drivers like that. For example, a truck crossed the center line and hit a GMC Yukon, killing four people. The driver was an illegal alien with a history of arrests and safety violations. After the crash, he admitted to his employer that he had exaggerated his truck driving experience, had a fake social security number, and was in the country illegally. The company kept him driving for another eighteen months. That company, which operates over 150 trucks, has a history of safety problems and accidents. It is truly scary that companies and drivers like that are on the road endangering us every day.Trucks cause over 90,000 deaths and injuries a year. Many of those accidents are caused by companies that violate safety standards to maximize profits. Despite those huge numbers, the study suggests that the safety violations are more pervasive than the data show because a Government Accountability Office (GAO) report found that almost a third of commercial motor vehicle crashes are not reported to the federal government, although states are required to report them.
]]>As recently reported in the journal Radiology, researchers at the Albert Einstein College of Medicine have now demonstrated objectively the areas of the brain injured when concussion occurs. The study subjected patients who had sustained concussions to tradition MRI and CT scans, which routinely demonstrated that no structural injury had occurred. When neuropsychological testing showed effects upon their executive functions, however, the patients were then given a more sophisticated type of MRI scan known as diffusion tensor imaging (DTI). DTI can detect subtle changes in the brain by measuring the diffusion of water in the brain's white matter. The DTI studies in these patients showed the presence of major areas of structural damage located mainly in the brain's prefrontal cortex, a part of the brain essential for normal executive function. It is this area of the brain that is susceptible to injury in concussion, and such structures are involved in the cognitive processes that cause the functional deficits the patients were experiencing.
It is unfortunately the case that many people suffering mild traumatic brain injury are not properly advised about the possibility of functional deficit by either their medical or legal practioners. It is often that problems do not disclose themselves until a patient returns to more full function after orthopedic injuries have healed. It is when they try to reengage life at their former level of function that deficits begin to take shape. Using DTI as an adjunct to clinical evaluation will likely help identify those patients who should receive rehabilitation earlier when it is more useful to the patient.
We previously wrote about the advances DTI brings to this field, and that entry may also be of interest, January 22, 2008 entry.
Source:
Diffusion-Tensor Imaging Implicates Prefrontal Axonal Injury in Executive Function Impairment Following Very Mild Traumatic Brain Injury, Radiology
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