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FDA Backtracks on BPA Stance

Greg Webb — Wed, 20 Jan 2010 10:47:17 GMT

The FDA has recently announced a warning concerning the safety of BPA. This backtracks over the FDA’s previous position that BPA was not harmful. Although they’re not committing to the position that BPA is harmful to humans, recent studies have apparently shown the subtle effects of low doses of BPA in lab animals. This has been enough for federal health officials to express some concern. This new stance more or less aligns the FDA with findings issued by the National Toxicology Program. In their 2008 report they state that there is “some concern” for BPA’s “effects on the brain, behavior and prostate gland, in developing fetuses, infants and children.” BPA is often used in reusable food containers. It is also used in epoxy resins, often times lining cans to maintain the quality of food and beverages.

Originally posted at InjuryBoard by Greg Webb

Supplements - More Dangerous Than They Appear (Or Advertised)?

Greg Webb — Fri, 25 Sep 2009 01:00:00 GMT

In its September 7^th article “What’s Really in Supplements?” The Wall Street Journal (WSJ)discusses the harmful side effects of a growing trend in the American dietary and strength conditioning communities: the taking of over-the-counter supplements.

Many supplements purport to aid in the building of muscle mass or in weight loss, claiming to do what prescription or illegal drugs do via an herbal means. However, the truth is that a great deal of these supplements contain at least trace amounts of the very drugs they claim to emulate.

Recent reports from the Food and Drug Administration (FDA) address the discovery of illegal performance-enhancing drugs in “allegedly natural supplements.” The WSJ article states that “[n]early two-thirds of American adults take dietary supplements, a broad category that includes vitamins, minerals and herbal products.” Supplement manufacturers are able to get their products quickly to market because they don’t require the extensive testing that new drugs do, and thus don’t require approval by the FDA. Furthermore, the WSJ says that “supplements that are made from products that were on the U.S. market before 1994 – as most commonplace ones are – can be sold without being reviewed by the FDA beforehand. Companies that include newer substances are supposed to inform the agency before they go on the market, but they don’t have to wait for approval.”

The recent attention stirred by the reports will be discussed during a hearing this month by a Senate Judiciary subcommittee. The focus of the hearing will be on dietary-supplement safety.

While officials at the Council for Responsible Nutrition are arguing that “no new laws are needed, citing new FDA manufacturing standards for supplements…as well as a requirement for supplement makers to tell the FDA when they get reports of serious side effects, which took effect at the end of 2007,” consumer advocates continue to call for closer monitoring.

A 2007 survey conducted by the British lab HFL Sport Science regarding supplements “found the undisclosed presence of steroids in at least trace amounts in 25% of the 52 samples analyzed,” and a 2008 article published in the journal Gastroenterology claimed that “9% of the 300 cases then recorded” could potentially be linked to supplement-taking. Since December 2008, “the FDA has issued warnings about more than 70 weight-loss supplements that included potentially dangerous ingredients.” The side effects of such ingredients could include seizure, heart attack and stroke. Liver and kidney failure have also been common in cases where a supplement taken regularly contained anabolic steroids. “Ed Wyszumiala, general manager of dietary supplement programs for NSF International, a nonprofit organization in Ann Arbor, MI that certifies supplements’ safety, says the drugs and steroids likely get into the products through a combination of deliberate spiking and inadvertent contamination.”

Vice President Andrew Shao of the Council for Responsible Nutrition “says safety problems are a ‘rare occurrence.’” He considers the HFL survey a “‘marketing tactic’” and says that consumers need to know what they’re taking as well. This is true. Consumers who take dietary supplements should be aware their ingredients and what those ingredients do. Research has been conducted on numerous herbs, most of which can be found online. In addition, Travis Tygart, chief executive of the U.S. Anti-Doping Agency, says that people who are interested in take supplements should speak with a physician. This would also help prevent dangerous interactions between prescription drugs and the supplements.

Preventative measures could include researching evidence, side effects and interactions at the National Library of Medicine (www.medlineplus.gov) under “Drugs and Supplements,” searching for specific supplements at www.fda.gov, as well as reading closely into what a supplement’s packaging discloses in subtext. “Certain suffixes in chemical names are common for steroids or tweaked versions of them. Among them are –one, -ene, -iol and –bol, though these can also appear in the names of legitimate ingredients. Some products also use versions of steroid names in their brands, like ‘tren’ to connote trenbolone.”

People using supplements should be aware of warning symptoms that could be indicative of an escalating problem. These include nausea, weakness or fatigue, fever, abdominal pain, chest pain, shortness of breath, yellow corneas and skin, and discolored urine, as cited by the FDA as warning signs of potential steroid use.

The Wall Street Journal article contains a complete list of resources for researching supplements.

Originally posted at InjuryBoard by Greg Webb

Hospitals In VA, MD, DC Must Report Avoidable Mistakes

Greg Webb — Thu, 06 Aug 2009 14:11:50 GMT

Over the past year, there have been hundreds of incidents of death or serious medical harm that were disclosed by hospitals in the Washington DC area, preventable errors that until recently have not required public reporting. Under laws that took effect last year in Virginia and a few years earlier in DC and Maryland, hospitals must report to health officials the many serious injuries that patients may suffer in the course of treatment. For example, in one case in DC, a patient was readmitted to the hospital complaining of serious leg pain after the surgeon operated on the wrong part of his spine.

While the public record in Virginia discloses the names of the hospitals involved, DC’s and Maryland’s do not. All three regions, however, give the American public a glimpse into the mistakes health experts call “never events”, because they should never happen: operations on the wrong body part, sponges being left in patients after surgery, and medication errors. At least twenty states require hospitals to report any incidence of hospital-acquired infection as well.

Patients, insurers and regulators are beginning to use this information to nudge health-care providers to ensure that such events never happen. In the past, insurance companies were billed when a doctor, nurse, or technician was responsible for injuring a patient; Maryland health regulators estimate that insurance companies paid $522 million last year to cover preventable complications in hospitals, which occurred in 55,000 of the state’s 800,000 inpatient cases. Now, however, many private and public insurers are following Medicare’s lead by refusing payment as a punishment to hospitals. They hope this act will encourage hospitals to make improvements in their system of care. For example, they will not pay for treating a urinary tract infection caused by a catheter.

In Maryland, the hospital association has agreed not to bill insurance companies for eight mistakes, such as transfusions using the wrong blood type and surgery on the wrong side. As part of a new initiative program, the state commission will begin ranking its hospitals on how often they commit fifty-two preventable mistakes; hospitals that commit the most mistakes will be required to bill insurers at a lower rate than hospitals who commit fewer mistakes. Fines will also be implemented as punishment for mistakes.

Additionally, the hospital association in Virginia has agreed not to bill insurance companies for several errors caused by hospital staff. Anthem Blue Cross and Blue Shield, Virginia’s largest private insurer, has stopped paying hospitals for four surgical mistakes: when the wrong body part is operated on; when the wrong procedure is done; when a foreign object is left in the patient requiring additional surgery, and when the wrong patient is operated on.

Finally, in DC, hospitals, nursing homes and clinics have reported 529 mistakes form July 2007 to June 2008; fourteen of these led to the death of a patient. So far, the District has tried not to use financial incentives to affect the hospitals’ behavior.

Originally posted at InjuryBoard by Greg Webb

AP Report Shows Pharmaceuticals Tainting Drinking Water

Greg Webb — Mon, 27 Apr 2009 08:00:00 GMT

According to an investigation by the Associated Press, U.S. manufacturers, including drugmakers, have legally released at least 271 million pounds of pharmaceuticals into the waterways that often supply drinking water. Hundreds of pharmaceutical ingredients are used in drug manufacturing. For example, copper, which is also used in piping, is also used in contraceptives; nitroglycerine, which is used in explosives, is a heart drug.

Federal and industry officials say they do not know the extent to which manufacturers release the pharmaceuticals because no one tracks them. An analysis of about twenty years of federal data, however, found the government does unintentionally keep data on a few. Twenty-two of the compounds showed up on lists compiled by the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA). The EPA classifies them as industrial chemicals released into water under federal pollution laws, while the FDA monitors them as active pharmaceutical ingredients.

It is unknown how much of that 271 million pounds comes from drug manufacturers versus other manufacturers. Researchers claim the lack of testing has created a “don’t ask, don’t tell” policy regarding whether drugmakers are contributing to the pollution. Drugmakers have insisted that their manufacturing does not significantly contribute to what is being found in the water. Federal drug and water regulators concur, although there have been trace amounts of a wide variety of pharmaceuticals in drinking water, such as antibiotics, mood stabilizers and sex hormones.

Originally posted at InjuryBoard by Greg Webb

FDA Rules Regarding Internet Drug Ads Create Confusion

Greg Webb — Sun, 26 Apr 2009 08:00:00 GMT

Late last month, the Food and Drug Administration (FDA) sent strong warning letters to fourteen major pharmaceutical companies that the companies’ search advertisements, or the short text ads that run beside Google results, have to include risk information about each drug or else be removed. The letter cited examples of Celebrex, Propecia and Yaz, which did not include the precautions that the agency required. The drug manufacturer Merck, for example, was reprimanded by the FDA for making its drug Singulair appear safer than has been demonstrated. Many feel this is sign of increased vigilance in the new FDA administration.

Until the letters were issued, drug companies assumed there was a one-click rule, which required them to publish risk information within one click of their ads, or on the page that the ad linked to. The companies argued that the FDA is ignoring the realities of internet marketing; there is no way they can include all of the required information in the ads because Google only allows ninety-five characters for search ads. While companies are changing their ads to comply with the warning, executives say the solution is worse than the problem; advertisements are now even more misleading. Representatives for the FDA, however, say if there is not adequate risk information, or you overstate the benefit of a drug, that is false advertising; risk information is required on every advertisement no matter the medium.

Drug companies changed almost all of their ads after receiving the letters because they do not want to be on the wrong side of the FDA, however, the sense in the industry was that the letters were just telling what they should and shouldn’t do as opposed to giving strict mandates. Online advertisements are now using generic-sounding brand names to redirect to a brand’s website. Propecia, for example, now redirects links through a website called “hair-loss-medication.com” instead of propecia.com.

These solutions have problems, however, in that consumers may think these sites are neutral when they are really redirected to a sales site. In fact, Google will only allow pharmaceutical companies to redirect this way. Consumers will also rarely see the official websites in the sponsored search results and will instead see links to Canadian pharmacies and other unregulated herbal offerings.

Originally posted at InjuryBoard by Greg Webb

Pharmaceutical Drugs Produced Abroad Worry Experts and Legislators

Greg Webb — Sun, 08 Feb 2009 20:41:26 GMT

In 2004, Bristol-Myers Squibb, the last plant in the United States to manufacture key ingredients for important antibiotics like penicillin, announced it would close its factory in East Syracuse, New York. Few people worried about the effect this would have on national security at the time since most of the focus was on job loss. Now, however, many lawmakers and experts are becoming concerned that the United States is way too reliant on medicine from abroad. They are scared this leaves room for counterfeit medications, supply interruptions, and even bioterrorism, leading legislators to ask for a law that would require some drugs be made or stockpiled in the US.

Although many years ago most pills consumed in the US were made domestically, drug manufacturers have recently started moving to Asia where production costs are much lower and the Food and Drug Administration (FDA) inspects facilities less frequently than domestic plants. This has led to the critical ingredients for antibiotics, along with many other medications, now being made almost exclusively in China and India. For example, of the 1,154 pharmaceutical plants that are mentioned in generic drug applications to the FDA, only thirteen percent were located in the United States; forty-three percent were located in China and thirty-nine percent were located in India. Pharmaceutical companies do not like to reveal where their drug suppliers are located. Many even put the drug was manufactured in the United States on the label, though the listed plants are usually where the drug was pounded into pills and packaged.

The chairman of Cipla, one of the world’s most important suppliers of pharmaceutical ingredients, stated that if China stopped supplying pharmaceutical ingredients, the worldwide pharmaceutical industry would collapse. Currently, the Center for Disease Control has a stockpile of medications with enough antibiotics to treat about forty million people. If more are needed, however, the country lacks the resources to produce them since a penicillin fermenter would take years to build from scratch.

This writer finds this news to be very scary. The fact that our country is heavily dependant upon certain parts of the rest of the world for our energy resources, and our financing (China finances a lot of our borrowing), and now our pharmaceutical needs, is of great concern. How and why did we get to this place? Perhaps someone out there can tell me why this may not be as bad as it sounds. I am looking to be enlightened on this topic if possible. I do not see how it is good that we may be so dependent upon China for this need; perhaps we have the capability to, if pressed, increase our production.

Originally posted at InjuryBoard by Greg Webb

FDA To Reconsider Its Position On A Potentially Dangerous Chemical In Baby Bottles

Greg Webb — Tue, 06 Jan 2009 22:02:06 GMT

The Food and Drug Administration’s own advisory board accused the agency of failing to consider research on the dangers of bisphenol-A (BPA), a chemical found in many plastic baby bottles, plastic food containers and metal can linings, causing the agency to finally agree to reconsider the issue. Exposure to this chemical is widespread and was seen in the urine of nearly ninety-three percent of the sample population. Although the FDA’s draft risk assessment claimed the chemical was safe, this conclusion stood out among other research that considered the chemical dangerous. For example, the National Toxicology Program, a branch of the Department of Health and Human Services, has stated the chemical can harm the brain, behavior and the prostate gland in fetuses, infants and children. Canada has also added the chemical to a list of toxic substances and said it will ban the chemical from being used in polycarbonate baby bottles. A recent study by the Journal of the American Medical Association has found adults with high levels BPA in their urine were more susceptible to heart and liver disease as well as diabetes.

The FDA’s position was based on information gathered from two large multigenerational studies by research groups that received funding from the American Plastics Council. According to the deputy director of the agency’s Office of Food Additive Safety, the FDA reviewed other studies, however, the two multigenerational were the only ones that met its guidelines for determining safety for human consumption; the other studies were said to have lacked details about how the study was administered and did not include all of the raw data, which prevent agency scientists from conducting an independent audit. However, after receiving criticism from an independent advisory panel regarding the FDA’s stance, the agency’s science board subcommittee determined the FDA was wrong to disregard the other studies. This led to the agency’s decision to reconsider its position.

Although the agency has decided to reconsider its position, many products containing bisphenol-A are still on the market, leading many people to look for alternative BPA-free products; Philips, one of the world’s largest manufacturers of baby bottles, has started to make products with and without the chemical to allow customers to choose. Beginning in 2009, the company also decided it will no longer take orders for polycarbonate bottles.

Originally posted at InjuryBoard by Greg Webb

Medical Residents Urged To Get Sleep After 16 Hours

Greg Webb — Thu, 18 Dec 2008 10:22:37 GMT

A panel at the Institute of Medicine recommended that medical and surgical residents in hospitals work no more than 16 hours without taking a mandatory five-hour sleep break, along with other work rules. The panel also advised that residents should have greater supervision, and interns, who are in their first year of training after medical school, should have in-house supervisors rather than ones available only over the phone. Medical residencies last from three to seven years, depending on the specialty. These rules are more restrictive than rules implemented in 2003, which are heavily violated.

"[T]he science clearly shows that fatigue increases the chances of errors, and residents often work long hours without rest and regular time off," said the leader of the panel, Michael M.E. Johns, a physician and the chancellor of Emory University.

The maximum hours residents may work in a week is currently set at 80 hours, with shifts of 30 hours or less. Residents are also required to take at least four days a month off, but there is no restriction on when those days are taken. The requirements are set by the Accreditation Council for Graduate Medical Education, which oversees residency programs.

These restrictions, however, are widely violated. A survey of about 4,000 interns found that in the first year those rules were in effect, 84 percent reported working shifts that violated them at least one month of the year. Forty-three percent said they worked more than 80 hours per week. In 2005, a survey at Vanderbilt University Medical Center found that 85 percent of medical and surgical residents reported violating the 30-hour shift limit.

While fatigue causes a risk to patient harm, it also increases the risk of car accidents and depression for the residents themselves. A 1996 study found that pediatric residents who slept less than three hours a night when they were on call were twice as likely to be in car accidents as faculty members, who did not report sleep-deprived nights.

The panel made their new recommendations, but recognized that implementing the recommendations could make things worse because more patient handoffs would be required. Handoffs require passing information about patients to a receiving physician that has probably never seen or examined the patient, and are a known source of medical error. However, researchers "believe it is a fixable problem," said David F. Dinges, a sleep researcher at the University of Pennsylvania.

Originally posted at InjuryBoard by Greg Webb