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Doctor Agrees to Cut Drug Firm Ties

Mon, 05 Jan 2009 00:00:00 -0800

Dr. Joseph Biederman is the latest doctor whose activities with big pharmaceutical are under review. According to the Boston Globe’s Boston.com, Biederman, a well-known child psychiatrist who has advocated the use of antipsychotics to treat bipolar disorder in children, will be suspending his financial relationships with pharmaceutical companies until such time that an agreement with Massachusetts General Hospital —Biederman’s employer—can be reached.

Biederman is well known as being one of this country’s strongest proponents of diagnosing pediatric bipolar disorder noted the Boston Globe. As we’ve reported previously, Biederman has long advocated the use of atypical antipsychotics, like Risperdal, to treat children diagnosed with bipolar disorder. According to a report in the WSJ in November, Biederman and colleagues published many favorable Risperdal studies while he was receiving payments from the drugs maker, Johnson & Johnson.

Charles E. Grassley—Republican-Iowa—accused Beiderman of not disclosing over $1 million received from drug makers and a congressional investigation was initiated by Grassley this summer; Harvard Medical School is investigating the allegations said the Boston Globe.

Massachussetts General's agreement with Beiderman says, in part, that he will "not participate in any outside activities that are paid for or sponsored by industry, such as consulting activities and speaking engagements," reported the Boston Globe, which also noted Biederman is to cease any involvement with industry-funded activities within the hospital. These activities include research, the Boston Globe pointed out.

The Boston Globe also reported that a hospital spokeswomen said Beiderman has stepped down from a number of industry-funded clinical trials, although the doctor continues to see patients. Spokewoman Peggy Slasman would not provide information on the studies, said the Wall Street Journal (WSJ), but did confirm studies would continue, but without Beiderman leading them. The hospital agreement will remain in place until reviews of Beiderman’s relationships—including if he completely disclosed drug industry funding—with drug companies are completed said the Boston Globe.

Meanwhile, scandals involving undisclosed drug money for research and promotion are a growing trend among medical researchers. Fierce Healthcare noted that Emory University stripped the chairmanship from one of its psychiatric researchers when an investigation revealed he had not reported industry-sourced income. Prominent researcher Charles Nemeroff agreed to step down as chair of Emory’ Department of Psychiatry and Behavioral Sciences following an internal investigation into his financial ties to drug makers. It seemed, said the WSJ, Nemeroff failed to report to Emory over $800,000 he received from GlaxoSmithKline for over 250 speaking engagements from January 2000 to January 2006. According to the Atlanta Constitution-Journal, Emory’s investigation found Nemeroff also received income from other drug makers.

Also, David Sinclair, a professor at Harvard Medical School who sat on the scientific advisory board of supplement maker Shaklee Corporation where he helped promote a product that claimed to possess life-extending properties has stepped down. Sinclair left his seat after the WSJ raised questions about his support of Shaklee’s Vivix Cellular Anti-Aging Tonic. It seems, said the WSJ, that Sinclair touted Vivix—with resveratrol—for six months; that he told Shaklee salespeople at a summer conference, that “over a year ago, we set out together to do this, to make a product that you could actually activate these genetic pathways that can slow down aging”; and that he appeared on the radio with Shaklee’s chief doctor promoting Vivix. Sinclair continues as co-chief adviser to Sirtris Pharmaceuticals, a division Glaxo, which is studying resveratrol for use as a drug. Sinclair received over $8 million when Glaxo acquired Sirtris; the company pays him $297,000 annually as a consultant, said the WSJ.

Defective Fan Maker Fined $500,000

Mon, 05 Jan 2009 00:00:00 -0800

Lasko Products will pay $500,000 in a civil penalty for its failure to report defective fans, the U.S. Consumer Product Safety Commission (CPSC) just announced. The CPSC has provisionally accepted the fine to be paid by Lasko, which settles allegations that Lasko failed to immediately report incidents about its defective portable box and floor fans. Lasko—in agreeing to settle the issue—denies it knowingly violated the law.

The defective Lasko fans were sold between 2000 and 2004; in February 2006, CPSC and Lasko announced the recall of about 5.6 million fans. Between November 2002 and September 2005, Lasko received about 42 reports of fans overheating, smoking, melting, or catching fire, which resulted in nine personal injuries—including burns and smoke inhalation—and property damage, eight of which resulted in fires that caused extensive property damage. It seems that Lasko did not fully report the incidents to the CPSC until September 2005 and, because of this, the CPSC has alleged that Lasko failed to report that its defective fans could pose fire and burn hazards to consumers.

According to the CPSC, federal law requires firms to report to it within 24 hours after obtaining information reasonably supporting the conclusion that a product contains a defect which could create a substantial product hazard, creates an unreasonable risk of serious injury or death, or violates any consumer product safety rule, or any other rule, regulation, standard, or ban enforced by the agency.

The defective fans were manufactured in the United States; sold at discount department stores nationwide for between $10 and $25; and include 5.6 million Lasko, General Electric, Galaxy, and Air King Brand Box and Pivoting Floor Fans manufactured between January 1999 and July 2001. Styles and model numbers are either stamped or appear on a label on the bottom of the fans, are listed below include:

Lasko: Box Fan models 3700, 3723, 3733, 3750; Cyclone Fan models 3510, 3550, 3800, 35105; Wind Machine models 3300 and 3521; Air Companion model 3515; Air Director model 2135; and Wind Tunnel models 3400 and 3410.
General Electric: Box Fan model 106620 and Cyclone Fan models 106600 and 106630.
Galaxy: Box Fan model 3733.
Air King: Cyclone Fan 20-inch deluxe pivot fan model 9500 and Air Companion 15-inch deluxe pivot fan model 9515

Philly.com noted that fan and space heater maker Lasko was criticized by the CPSC for waiting several years before it reported the fire and burn hazards. "To have incidences of fire, to have incidences where somebody has been burned, and to not immediately turn that information over to CPSC is wholly unacceptable," CPSC spokesman Scott Wolfson said, adding, "A company cannot and should not, under federal law, wait years—years—to report to the federal government when there are incidents that rise to the level of fires with a consumer product, incidents that lead to personal injury of consumers," according to Philly.com.

Consumers with recalled fans can receive a free fan cord adaptor designed to shut the fan motor off if overheating occurs; Lasko can be reached toll-free at (800) 984-3311, or at the firm’s Website at www.laskoproducts.com/recall/recall_fans.html.

California Phthalate Ban Now in Effect

Mon, 05 Jan 2009 00:00:00 -0800

California has officially banned phthalates in children’s products in advance of the federal law that comes into effect next month. The McClatchy-Tribune News Service reported that the law went into effect late last week and bans the sale of phthalate-containing toys and children’s products. In response to the CPSC law, California Attorney General Jerry Brown told the CPSC last month that the federal government “had no authority to preempt California's stricter version,” said McClatchy-Tribune.

The ban means that these products may not contain in excess of 0.1 percent phthalates, reported the news service, adding that this is the “strictest standard nationwide for phthalates in consumer products.” Phhalates are toxic plastic-softening chemicals that can be found in some children’s toys and products and which have been making headlines lately over pending implementation of a ban on these toxins. Some studies have linked phthalates to a variety of health issues that include hormonal problems in children.

The federal law involves children’s toys and products manufactured after February 10, a point of contention between industry and advocates. As a matter-of-fact, The U.S. Consumer Product Safety Commission (CPSC) is being sued by both the Natural Resources Defense Council and Public Citizen, two consumer advocacy groups, Reuters reported. The groups say the CPSC appears to be looking to only implement parts of the ban, said Reuters; NaturalNews.com noted that the CPSC seems to be working in the interests of big business at the expense of America’s children and babies. The lawsuit says that despite that the February 10, 2009 ban mandates otherwise, the CPSC is allowing toxic toys and children’s products to be made prior to the ban, said Reuters. This means that toxic toys will not only continue to be sold in stores prior to the ban, they could very well be sold after the ban’s implementation date, which many feel goes against the original intent of the ban.

Ed Weil, a supervising deputy attorney general with the Office of the Attorney General in Oakland told the McClatchy-Tribune News Service that, "As long as you got it off the assembly line in time, you could sell it for the next five years." Meanwhile, also according to the news service, CPSC spokesman Scott Wolfson said that, "The Consumer Product Safety Commission respects the law as passed in California, and its implementation starting this week." McClatchy-Tribune explained that the law bans six phthalates found in some children's toys containing plastic and requires that substitutes used in place of the chemical be less toxic.

McClatchy-Tribune also pointed out that during 2008, the San Francisco Department of the Environment tested a variety toys manufactured with polyvinyl chloride, a chemical that can contain high levels of phthalates. Debbie Raphael, who manages the department's toxics reduction program, told McClatchy-Tribune that about half of the toys tested contained the toxin and that while in one case a toy had none, its copied version had 40 percent. Weil told the news service he is worried about “deep discount” stores because they tend to purchase older stock from other stores and could potentially sell phthalate-heavy items manufactured before the ban date.

China Melamine Scandal Affects American Adoptions

Mon, 05 Jan 2009 00:00:00 -0800

The ongoing and far-reaching China melamine scandal, in which tainted milk powder killed at least six children and sickened nearly 300,000, has spread to another group: Adopted Chinese children now living in the U.S. Children exposed to China-produced formula in 2007 and 2008 are of particular concern.

The group Families with Children from China recently sent a letter to parents and adoptive advocates regarding the melamine catastophe stating that, based on information derived from the American Academy of Pediatrics, there is no consensus on the impact of melamine on Chinese babies. The group noted that some physicians are advising that any child who ever lived in China be tested, while others suggest only testing children exhibiting symptoms of melamine contamination. The group also stated that the AAP Section on Adoption and Foster Care, the American Society of Pediatric Nephrology, and others are investigating the matter and hoping to reach accord. Tests for kidney disease include blood and urine screening and renal ultrasound testing.

Melamine is an industrial chemical used in the manufacture of fertilizer, fire retardants, and plastics and has been at the center of a global scandal originating in China over the adulturation of a wide variety of food products with a variety of contaminants. In particular, melamine has been used in that country to falsify protein levels. Because melamine contains such high nitrogen contents, it can be used to make certain foods—for instance intentionally diluted milk products and baby formula—appear high in protein in certain tests, enabling producers and manufacturers to pass off sub-standard products as protein-rich. The melamine milk scandal first broke after tens of thousands of Chinese babies were sickened, hospitalized, or died as a result of melamine contamination, which can lead to kidney problems such as kidney stones and kidney failure and, in the case of at least six of the babies, death.

The American Academy of Pediatrics for China Adoptive Families also issued a letter stating that, so far, it has heard from three families whose children were diagnosed with kidney stones; two of the adoptions occurred as far back as 2005. The group contacted adoptive medicine specialist Dr. Dana Johnson at the University of Minnesota’s International Adoption Medical Clinic. Johnson then contacted the Adoption and Foster Care section of the American Academy of Pediatrics, which advised that “... the consensus is to do urinalysis and BUN/Creatanine on all children adopted from China from 2005 onward and if abnormal, get a renal ultrasound."

The Associated Press has also reported on cases of parents being advised by their adoption agencies regarding melamine in Chinese baby formula. In one such case, the baby had no symptoms, but was found—via ultrasound—to have two kidney stones. Symptoms can include, said the AP, blood in the urine, kidney pain, and unexplained crying, to name a few. The AP also pointed out that some orphanages using so-called safe formulas might have supplemented their formula with donated formula that could have been tainted.

Although initial figures indicated about 50,000 children fell ill from melamine contamination, the Chinese government finally released information confirming that nearly 300,000 babies fell ill in that country with urinary and kidney problems linked to melamine tainting.

Cipro, Levaquin Still Popular Despite Tendon Risks

Mon, 05 Jan 2009 00:00:00 -0800

Despite the fact that Cipro, Levaquin and other antibiotics called fluoroquinolones have been linked to serious tendon damage - including ruptures of the Achilles heel - not many patients are aware of the risk. According to an article in The Atlanta Constitution-Journal, drugs like Cipro and Levaquin are still being over-prescribed at an alarming rate in spite of this danger.

The first fluoroquinolone was introduced in 1986. Critics of these drugs allege that fluoroquinolone antibiotics were developed and put on the fast track for Food & Drug Administration (FDA) approval without the benefit of adequate premarket testing to accurately determine the probability of certain side effects within the general population. After gaining FDA approval, the new fluoroquinolone antibiotics were aggressively marketed by the manufacturers.

Cipro became widely known when it was used to treat and prevent anthrax infections in people exposed to the virus as a result of the 2001 mail attacks. While Cipro was apparently an effective weapon against anthrax, it left some victims with lingering health problems.

Last July, the FDA asked the manufacturers of Cipro and other fluoroquinolones to add a black box warning to the drugs’ labels about their association with tendon damage. The FDA said the risk of tendon damage was greatest for those over age 60, those on concomitant steroid therapy, and kidney, heart, and lung transplant recipients. The ruptures generally related to the use of fluoroquinolones involve the Achilles tendon as well as ruptures of the shoulder, hand, biceps, and thumbs. At the time of the warning, he FDA has received nearly 2,250 reports of tendon disorders and 775 reports of tendon ruptures among patients taking fluoroquinolones, though the actual numbers are likely much greater since most side effects are never reported.

According to the Atlanta Constitution-Journal, the tendon risks associated with fluoroquinolones have been known for close to 20 years. The FDA warning only came after the agency was sued by a consumer group for ignoring the drugs' safety risks.

When the FDA finally had the makers of these drugs add warnings to their labels, it stopped short of requiring that drug companies send letters to doctors alerting them of the change. Only a few, such as Bayer HealthCare Pharmaceuticals the maker of Cipro and Avelox, and Oscient Pharmaceuticals, which sells Factive, have voluntarily done so.

As a result, fluoroquinolones are still being prescribed at a high rate, despite the fact that there are safer alternatives. According to the Atlanta Constitution-Journal, in 2007, U.S. patients received more than 40 million prescriptions for fluoroquinolone antibiotics. What's worse, studies have shown that these drugs are often used to treat diseases that don't even respond to antibiotics.

The fact that few doctors and patients are aware of the risks of fluoroquinolones is a serious concerns. The tendon damage often caused by these antibiotics can be mitigated if patients are treated - and switched to another antibiotic - as soon as they start feeling pain. But without the right knowledge, most won't even know the medicine they are taking could be causing their discomfort. If they continue taking the drug, the result could be a tendon rupture, which will require even more intervention - including surgery.

Bacon Bits Recalled for Listeria

Mon, 05 Jan 2009 00:00:00 -0800

Bacon bits are the latest food product to be recalled for listeria contamination. The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) just announced that two Patrick Cudahy bacon bit products are being recalled for possible contamination with the listeria monocytogenes bacteria, a dangerous, sometimes deadly, foodborne contaminant.

Patrick Cudahy is recalling two different versions of its 10-pound cases of Applewood Smoked Precooked Bacon toppings: Golden Crisp and John Morrell. The Applewood Smoked Precooked Bacon topping products bear the establishment number “EST. 28” within the USDA inspection mark and a printed Julian date of “8318.” The Applewood Smoked Precooked Bacon bit products were produced on November 13, 2008, and distributed to restaurant and institutional establishments in California, Colorado, Florida, South Dakota, Texas, and Wisconsin. The listeria monocytogenes contamination was discovered through in-house testing by an establishment that received the product.

The listeria bacterium is found in soil, vegetation, raw milk, meat, poultry, cheeses (particularly soft mold-ripened varieties), and salad vegetables. About 2,500 cases of listeria occur in the United States annually with about 200 in every 1000 cases resulting in death. Listeria monocytogenes can grow at low temperatures, even in refrigerated environments; thorough cooking of food and milk pasteurization can destroy the Listeria bacteria. Listeria often invades the body through a normal and intact gastrointestinal tract and, once in the body, can travel through the blood stream.

Listeriosis—the illness caused by the listeria bacteria—symptoms can develop in days or weeks and can vary from a mild flu-like illness to meningitis and septicemia; pregnant women can experience anything from miscarriage, still birth, or birth of an infected child. Pregnant women are about 20 times likelier than others to be infected, with about one-third of listeriosis cases occurring during pregnancy; the incidence of listeriosis in newborns is 8.6 per 100,000 live births and the perinatal and neonatal mortality rate (stillbirths and early infant deaths) is 80 percent. Those with compromised immune systems—such as people undergoing chemotherapy treatment or those diagnosed with HIV/AIDs and hepatitis—the very young, and the very old are also at risk.

To help prevent listeria contamination, consumers are generally advised to thoroughly cook raw food from animal sources; keep uncooked meats separate from vegetables and from cooked and ready-to-eat foods; avoid unpasteurized (raw) milk or foods made from unpasteurized milk; wash hands, knives, and cutting boards after handling uncooked foods; wash raw vegetables thoroughly before eating; and consume perishable and ready-to-eat foods as soon as possible and within their expiration dates.

Patrick Cudahy company Director of Customer Service Mike Reitz can be reached at (414) 744-2000. "Ask Karen" is the FSIS virtual representative, which is available 24 hours a day at AskKaren.gov. for food safety questions. The toll-free USDA Meat and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and Spanish from 10:00 a.m. to 4:00 p.m. (Eastern Time) Monday through Friday; recorded food safety messages are available 24 hours a day.

Third Hand Smoke Dangers Not Well Recognized

Mon, 05 Jan 2009 00:00:00 -0800

The hazards of first and second hand smoke are well known. But now, researchers have raised concerns about the dangers of so-called "third hand smoke" - the tobacco residue that lingers on clothes and hair, as well as furniture and in carpets, long after a cigarette has been extinguished. According to The New York Times, third hand smoke could be especially toxic to children.

The Times said the term "third hand smoke" originated with researchers at Massachusetts General Hospital for Children. They say that third hand smoke contains heavy metals, carcinogens and even radioactive materials. According to The New York Times, young children playing or crawling on the floor could face health dangers because of exposure to third hand smoke.

Unfortunately, most people don't have a clue about third hand smoke dangers. According to a study conducted by the Massachusetts General researchers, most smokers and non-smokers know the dangers of first and second hand smoke. But only about 65 percent of non-smokers, and 43 percent of smokers agreed with the statement that “breathing air in a room today where people smoked yesterday can harm the health of infants and children.”

According to the study, which was published in the journal Pediatrics, knowledge that first and second hand smoke can hurt kids didn't always mean respondents completely banned smoking in their homes. Rather, they may have just banned the activity when kids were around. The researchers concluded that educating the public about the dangers of third hand smoke could encourage more people to completely ban smoking from their homes.

Speaking of smoking bans, it seems that they can be an effective way to improve public health. According to a new study from the Centers for Disease Control (CDC), public smoking bans may have caused a reduction in heart attack rates.

For the CDC study, researchers looked at the effects of a public and workplace smoking ban implemented in Pueblo, Colorado, in 2003. The number of people hospitalized for heart attacks dropped significantly after the smoking ban was in place. In the 18 months prior to the ban, there were 400 heart attacks; after the ban the number dropped to 237. The study found no significant changes in heart attack rates in those areas without smoking bans.

The results of the CDC study concur with earlier studies on smoking bans. Another report issued by the CDC showed that New York City’s smoking rate has plummeted since anti-smoking measures were adopted in 2002. Similar results were seen in Scotland after a smoking ban was implemented in 2006.

Madoff Investment Business Probed By SEC Eight Times, Yet No Fraud Found

Mon, 05 Jan 2009 00:00:00 -0800

Federal securities regulators investigated Bernard L. Madoff Investment Securities LLC a total of 8 times in the last 16 years. But according to The Wall Street Journal, even though the Securities and Exchange Commission (SEC) conducted so many examinations, and interviewed Madoff at least twice, it failed to turn up evidence of the $50 billion Ponzi scheme he allegedly ran for decades.

The 70-year-old Madoff was arrested on one count of securities fraud on December 11. Madoff - once a chairman of the Nasdaq stock exchange - is the founder and primary owner of Bernard L. Madoff Investment Securities LLC. The firm is primarily known for its business in market-making, or serving as the middleman between buyers and sellers of shares. However, Madoff also oversaw an investment-advisory business that managed money for high-net-worth individuals, hedge funds and other institutions.

According to the FBI complaint against Madoff, that business was largely a Ponzi scheme. The FBI said Madoff “deceived investors by operating a securities business in which he traded and lost investor money, and then paid certain investors purported returns on investment with the principal received from other, different investors, which resulted in losses of approximately billions of dollars.” Madoff reportedly told employees that his fraud could cost investors as much as $50 billion.

According to The Wall Street Journal, the SEC received numerous tips about irregularities involving Madoff, and conducted more than half-dozen examinations of his investment advisory business. The tips the SEC received included:

Emails from a New York hedge fund that described Madoff's business practices as "highly unusual."
Reports in 2001 by Barron's, and the hedge-fund trade publication MarHedge which suggested Madoff was front running for favored clients.
A 2007 report by the Financial Industry Regulatory Authority that said parts of Madoff's firm appeared to have no customers.

Yet, as the Journal reports, Madoff was able to keep regulators from discovering his alleged scheme. Regulatory gaps appear to be part of the reason Madoff was able to evade the SEC. For one thing, rather than telling regulators he ran an investment-advisory business, Madoff said he managed accounts for hedge funds. This assertion allowed Madoff was to avoid regular reviews of the advisory business, the Journal said.

When SEC examinations did turn up questions, Madoff always had ready answers. For example, In 1999 and 2000, SEC examiners raised concerns that Madoff was violating a trading rule properly displaying orders to others in the market. To put these questions to rest, Madoff outlined new procedures for the firm to follow, the Journal said.

In 2005, the SEC opened an enforcement investigation of Madoff's business, prompted in part by concerns brought to the agency by one Madoff critic. According to a memo obtained by The Wall Street Journal, the agency was trying to determine if charges that Madoff "is operating a Ponzi scheme has any factual basis."

According to the Journal, that SEC investigation did find some problems. For one thing, it said that neither Madoff nor another firm that funneled money to him, had told investors that Madoff was the one making investment decision . The investigation also found that Madoff misled the SEC in 2005 about the strategy he used for customer accounts, withheld information about the accounts and violated SEC rules by operating as an unregistered investment adviser, the Journal said. However, the investigation turned up no evidence of fraud. In the end, Madoff agreed to register his business, and the findings of the SEC were never made public, the Journal said.

The SEC will have a chance today to explain its failure to detect Madoff's alleged fraud during a hearing of the House Financial Services Committee. As we reported last week, committee member Paul Kanjorski (D-PA) said in an email statement that the hearing will “help us to discern whether or not the Securities and Exchange Commission had the resources needed to get the job done, how such a sizable scheme could have evaded detection for so long, and what new safeguards we need to put in place to protect investors.”

According to Reuters, SEC Inspector General David Kotz, who is probing the agency’s oversight failures in the Madoff case, will be called to testify at the hearing. Harry Markopolos, the former chief investment officer at Rampart Investment Management who said he repeatedly tried to get the SEC to investigate Madoff, will also appear, Reuters said.

Leaks Reported at TVA Fly Ash Pond in Years Before Spill

Mon, 05 Jan 2009 00:00:00 -0800

Disturbing questions are being raised about last month's Tennessee fly ash spill. According to a report in The Chattanooga Times Free Press, the fly ash retention pond at the Tennessee Valley Authority (TVA) Kingston Fossil Plant had experienced several leaks over the past decade. Yet even though it knew about such problems, the TVA continued to allow coal waste to be dumped there.

The Tennessee fly ash spill occurred around 1:00 a.m. on December 22 after a wall holding back 80 acres of sludge from the TVA’s facility in Roane County, Tennessee broke. Though the exact cause of the accident was not known, it was thought that six inches of rain over the previous 10 days and overnight temperatures in the teens contributed to the dam breach.

The TVA said that up to 400 acres of land had been coated by the sludge, making it 48 times larger than the 1989 Exxon Valdez spill in Alaska. The authority now says that 5.4 million cubic yards of potentially toxic fly ash was released from a retention pond. According to the Knoxville News, that’s triple the estimate of 1.7 million cubic yards the TVA first released. The fly ash spill damaged 15 homes. All the residents were evacuated, but at least three homes were deemed uninhabitable.

According to the Chattanooga Times Free Press, in 2003 and 2006, leaks at the Kingston plant's retention pond were so bad that TVA repaired drainage and dikes around the pond. In fact, the authority suspended all deposits in the landfill for nearly 18 months to allow the dredge cell to dry out and stabilize, the Free Press said.

Once the repairs were made, the TVA believed the problems were solved. According to the Free Press, a report on a 2007 TVA inspection of the pond found no hazards, and concluded previous issues had been corrected. Another performed just this past October was not yet available, the Free Press said. But just two months after that last inspection, the dike at the retention pond broke.

What's worse, even after the spill, the TVA didn't even know how much coal waste had been released. As previously reported, the authority revised the initial estimate just days after the spill, nearly tripling it. The director of Southern Alliance for Clean Energy told the Free Press that a lack of regulation likely contributed to the confusion.

According to the Free Press, state agencies, such as the Tennessee Department of Environment and Conservation (TDEC), control how utilities dispose of coal ash from power plants. During a tour of the site over the weekend, Tennessee's governor said that the TDEC may have relied too much on TVA’s own inspections of the pond.

Inspector General Faults EPA Jet Fuel Report

Fri, 02 Jan 2009 00:00:00 -0800

The Environmental Protection Administration (EPA) has long ignored the need remove perchlorate—a toxic rocket-fuel ingredient—from public water supplies. Now, according to a recently released EPA letter written by its Deputy Inspector General, Bill A. Roderick, it seems that the EPA is reevaluating its original determination and has said that its initial report should have used a cumulative risk assessment for perchlorate, among other chemicals and should have also looked at iodine in the American diet. In other words, the EPA erred in its original reporting.

Years ago, the military and missile makers dumped perchlorate into the ground where it has since spread into wells and rivers nationwide, but, according to the DPA, it was okay to leave the poison in the nation’s water, reported the SFGate. Worse, points out the Boston Phoenix, the Bush Administration blocked a multi-year EPA initiative to limit perchlorate in the nation’s drinking water. Most perchlorate “plumes” in the United States range between four and 100 ppb. To date, the EPA has identified 75 such plumes in 22 states, including Arizona, Texas, Nebraska, Iowa, New York, Maryland, Massachusetts, and California; defense-industry dumping is suspected in nearly all these cases. The SFGate reported that perchlorate contamination can be found in at least 35 states and 153 public water system.

Perchlorate is one of a group of toxins called endocrine disrupters, which can alter hormonal balances and impede human reproduction and development. Although the EPA has said that based on laboratory and epidemiological studies, perchlorate is dangerous in drinking water at levels above one part per billion (ppb), at the national level, it is closing in on formally determining that setting a perchlorate standard in drinking water is not necessary.

The EPA says it will take hundreds of years and cost several billion dollars to clean up the plumes and in September said that setting perchlorate limits would not result in a "meaningful opportunity for health risk reduction," quoted the SFGate, pointing out that the government seemed to be more concerned about perchlorate clean-up costs over human safety. Also, the government stopped EPA activities after listening to key members in industry—namely, Lockheed Martin and Aerojet—which clamed perchlorate risks were overstated, said the SFGate.

The EPA’s negligence has far-flung effects. Perchlorate inteferes with thyroid gland processes, how iodide is utilized, and with mental and physical development in fetuses and infants. And, according to the Redlands Daily Facts and the Inland Valley Daily Bulletin, a variety of emerging studies—including one from 2006 by the national Centers for Disease Control and Prevention (CDC)—concluded that even low perchlorate levels can affect thyroid hormone levels in women. The Redlands Daily Facts and the Inland Valley Daily Bulletin are both reporting that the California Office of Environmental Health Hazard Assessment will review the public health goal for perchlorate in 2009, according to an email sent by Sam Delson, the office's deputy director for external and legislative affairs. This could lead to setting a new drinking water standard for the toxin, WaterTechOnline.com noted.

Medication Errors Often Seen in Chemotherapy Treatment

Fri, 02 Jan 2009 00:00:00 -0800

Medication errors are more common that previously believed in chemotherapy treatment. It seems about seven percent of adults and 19 percent of children receiving outpatient chemotherapy treatment—in clinics or at home—have been subjected to incorrect dosing or other medication mistakes, according to a new study by the University of Massachusetts Medical School, reports Science Daily. The team looked at the records of nearly 11,000 drugs taken by cancer patients at three adult and one pediatric oncology clinics said White Coat Notes, which added that an earlier study that only looked at medications given at a cancer center revealed a three percent error rate.

Study lead Kathleen E. Walsh, MD, assistant professor of pediatrics at the University of Massachusetts Medical School and a Robert Wood Johnson Physician Faculty Scholar, said, "As cancer care continues to shift from the hospital to the outpatient setting, the complexity of care is increasing, as is the potential for medication errors, particularly in the outpatient and home settings," quoted Science Daily. Science Daily also noted that data analysis on about 1,300 adult patient visits and 117 pediatric visits from September 1, 2005 and May 31, 2006 revealed medication errors were more common than previously reported.

Of 90 medication errors—such as incorrect dosing due to confusion, conflicting orders, and overhydration—involving adults, 55 could have potentially harmed the patient, while 11 caused harm, said Science Daily. Over half of the errors to adults involved clinical administration; 28 percent, the ordering of drugs; and seven percent, use of medication in patients homes, said Science Daily, adding that 40 percent of 22 errors in children harmed four and could have potentially harmed the rest. Some errors in pediatric dosing occurred over wrong medication amounts or frequency, reported WebMD. Errors in adult dosing occurred, WebMD added, over confusion over conflicting orders, overhydration prior to treatment, and abdominal pain because treatment for constipation did not occur prior to treatment, for example.

"As cancer care shifts from the hospital to the outpatient setting, adults and children with cancer receive more complicated, potentially toxic medication regiments in the clinic and home," the team wrote, said WebMD. The study was published in the Journal of Clinical Onclology, said WebMD, which pointed out that the journal described the errors as “high” in both adult and pediatric cancer patients.

The team concluded, reports the Washington Post, that treatment orders should be written on the day of treatment and pediatric care include improved communication and training as well as heightened parental support. "Requiring that medication orders be written on the day of administration, following review of lab results, may be a simple strategy for preventing errors among adults, while most of the errors involving children may have been avoided by better communication and support for parents of children who use chemotherapy medications at home," said Dr. Walsh, quoted Science Daily.

White Coat Notes said that most errors involved dosing errors usually resulting from duplicate orders—one written at diagnosis and one at treatment. Only five such errors were caught before treatment said White Coat Notes. WebMD pointed out that the researchers indicated that prevention of such outpatient medical errors fails because of a variety of issues such as “a lack of recognition of errors, communication problems, and fragmentation of care."

Fosamax, Other Osteoporosis Drugs Linked to Cancer

Fri, 02 Jan 2009 00:00:00 -0800

Popular drugs used to treat osteoporosis may be linked to a risk of esophageal cancer according to the U.S. Food and Drug Administration (FDA). Reuters is reporting that Merck’s Fosamax (generically known as alendronate) may be among the bone drugs that carry such a risk. About 10 million Americans—the vast majority of whom are female—suffer from osteoporosis, said Reuters.

Reuters reports that Diane Wysowski of the FDA's drug risk assessment division advised researchers to review links between bisphosphonates and an increased cancer risk. Health Day News explained that bisphosphonates are used to reduce the risk of bone fracture, while increasing bone mass in patients suffering from osteoporosis and are used to decelerate bone "turnover" in cancer patients whose disease reached the bones as well as those suffering from multiple myeloma, a type of blood cancer. Bisphosphonates such as Fosamax have also been linked to an increased risk of atrial fibrillation, thigh bone fractures, and inflammatory eye disease, said HealthDayNews.

Wysowski discussed a letter in yesterday’s New England Journal of Medicine in which 23 patients developing esophageal tumors have been reported since Fosamax was first marketed in 1995, says Reuters; eight patients died. Wysowski added, said Reuters, there seems to be a two-year period between initiating Fosamax and developing the cancer. Also, said Reuters, in Europe and Japan, 21 cases involving Fosamax have been reported with six cases linked to Procter & Gamble's Actonel (risedronate) and Didronel (etidronate), and Roche's Boniva (ibandronate); six patients have died.

Fosamax and other bisphosphonates treatment involves patients remaining upright for at least one-half hour following dosing because of the well-established side effect of esophagitis, inflammation of the esophagus, reports Reuters. Wysowski also warned physicians should not prescribe bisphosphonates to patients with Barrett's esophagus, a condition in which an esophageal change common in acid reflux patients occurs and that is also known to increase cancer risks, added Reuters.

Meanwhile, HealthDayNews reports that oral osteoporosis drugs are linked, in much greater incidence than was first believed to osteonecrosis of the jaw (ONJ); the risk is increased with the higher-dose intravenous (IV) form of bisphosphonates. Dr. Parish Sedghizadeh, an assistant professor of clinical dentistry at the University of Southern California School of Dentistry in Los Angeles, told HealthDayNews that his clinic has seen a seriously marked increase in such cases: In the past the clinic would see one case annually and is now seeing one to four cases weekly.

The findings prompted his investigation and are published in yesterday’s Journal of the American Dental Association, said HealthDayNews. According to HealthDayNews, OSJ is known to cause pain, soft-tissue swelling, infection, loose teeth, and exposed bone and can occur in patients taking Fosamax as short as one year and tends to occur following invasive dental work.

Last year, the FDA posted an alert on its Website stating that patients being treated with bisphosphonates might develop “disabling pain” in the muscles, joints, and bones—a known risk detailed in the warning label; in some cases, the pain is reported to be "incapacitating" for normal movement like walking.

Burritos Recalled Over Listeria Contamination

Fri, 02 Jan 2009 00:00:00 -0800

Burritos tainted with the listeria monocytogenes pathogen are being recalled. Home Fresh Sandwich Distributors, Inc. has recalled 172 pounds of its 7-Eleven Fresh to Go Burritos with Potatoes, Bacon Eggs, and Monterey Jack Cheese sandwiches, the U.S. Department of Agriculture (USDA) announced, according to ConsumerAffairs.com.

The recalled 7-Eleven Fresh to Go Burritos contain a "Best By" date of "Thursday 1225" and the establishment number "EST. 19496" inside the USDA mark of inspection said ConsumerAffairs.com. The listeria-tainted burritos were produced on December 23, 2008 and were sold at Colorado convenience stores said the USDA, reported ConsumerAffairs.com, which notes that products might have been purchased on December 24 and 25, 2008.

Listeria is a bacterium found in soil, vegetation, raw milk, meat, poultry, cheeses (particularly soft mold-ripened varieties), and salad vegetables as well as in animals and humans. It is estimated that about 2,500 cases of listeria occur in the United States each year with about 200 in every 1000 cases resulting in death. Listeria monocytogenes can grow at low temperatures, even in refrigerated environments; thorough cooking of food and milk pasteurization can destroy the listeria bacteria. Listeria often invades the body through a normal and intact gastrointestinal tract and, once in the body, can travel through the blood stream. The bacteria are often found inside cells where toxins are produced resulting in damaged cells.

ConsumerAffairs.com reported that it was during routine microbiological testing by the USDA’s Food Safety and Inspection Service (FSIS) that the contamination was revealed. The USDA warns, said ConsumerAffairs.com that consuming Listeria-contaminated foods can cause listeriosis. Listeriosis—the illness caused by the listeria bacteria—symptoms can develop in days or weeks and can vary from a mild flu-like illness to meningitis and septicemia; pregnant women can experience anything from miscarriage, still birth, or birth of an infected child. Pregnant women are about 20 times likelier than others to be infected, with about one-third of listeriosis cases occurring during pregnancy; the incidence of listeriosis in newborns is 8.6 per 100,000 live births and the perinatal and neonatal mortality rate (stillbirths and early infant deaths) is 80%. Those with compromised immune systems—such as those undergoing chemotherapy treatment or those diagnosed with HIV/AIDs and hepatitis—the very young, and the very old are
also at risk. All at-risk individuals are advised to avoid certain foods, such as soft mold-ripened cheeses and pates, given those foods’ high incidence of being linked to listeria infection.

To avoid listeria contamination, consumers are generally advised to thoroughly cook raw food from animal sources; keep uncooked meats separate from vegetables and from cooked and ready-to-eat foods; avoid unpasteurized (raw) milk or foods made from unpasteurized milk; wash hands, knives, and cutting boards after handling uncooked foods; wash raw vegetables thoroughly before eating; and consume perishable and ready-to-eat foods as soon as possible and within their expiration dates.

Last week, the FSIS announced that DeNiro Cheese, a Youngstown, Ohio, firm, recalled approximately one pound of its Sopressata sausage products over concerns of Listeria monocytogenes contamination.

Wind May Have Played Role in Denver Plane Crash

Fri, 02 Jan 2009 00:00:00 -0800

Federal transportation officials are trying to determine if high wind gusts played a role in pushing a Continental airlines flight off a runway at Denver International Airport last month, injuring 37 people. According to the Associated Press, wind gusts at the time of the accident measured as high as 37 mph.

The Denver plane crash occurred at around 6:18 p.m. on December 28, when Continental flight 1404 to Houston was attempting to take off from Denver International Airport. According to USA Today, a spokesperson for the National Transportation Safety Board (NTSB) said the aircraft had traveled about one third of the length of the runway when it veered to the left and skidded into a ravine.

The aircraft broke apart upon impact and burst into flames. The plane’s left engine was ripped away along with all the landing gear, the Associated Press said. According to airport officials, the runway was free of snow and dry at the time of the crash.

According to the NTSB lead investigator, the plane’s data recorder revealed that the thrust-reversers - which are deployed to stop an aircraft on a runway - on both of the plane’s engines were activated. One of the pilots also can be heard on the recorder calling for an aborted takeoff, the investigator said.

According to the Associated Press, winds around the time of the crash were at about 27 mph, with gusts to nearly 37 mph. However, the report said such cross wind speeds would not have prevented the plane from taking off, and they should not have affected the pilots' ability to control the aircraft.

In addition to crosswinds, the NTSB is looking into several other factors that could have played a role in the crash, including rudder, break and engine problems.

The Rocky Mountain News is reporting that wreckage from the crash is expected to be removed from the runway today, and will be stored in a secure location at the Denver airport.

Madoff Asset List to Be Filed Today

Fri, 02 Jan 2009 00:00:00 -0800

Bernard Madoff will comply with a court order to furnish the Securities and Exchange Commission (SEC) with a list of his assets. According to Reuters, the accused Ponzi schemer's lawyer said the information would be filed today, in time for a Wednesday deadline.

The 70-year-old Madoff was arrested on one count of securities fraud on December 11. Madoff - once a chairman of the Nasdaq stock exchange - is the founder and primary owner of Bernard L. Madoff Investment Securities LLC. The firm is primarily known for its business in market-making, or serving as the middleman between buyers and sellers of shares. However, Madoff also oversaw an investment-advisory business that managed money for high-net-worth individuals, hedge funds and other institutions.

According to the FBI complaint against Madoff, that business was largely a Ponzi scheme. The FBI said Madoff “deceived investors by operating a securities business in which he traded and lost investor money, and then paid certain investors purported returns on investment with the principal received from other, different investors, which resulted in losses of approximately billions of dollars.” Madoff reportedly told employees that his fraud could cost investors as much as $50 billion.

A December 18 court order required Madoff to provide the SEC with a listing of his assets. According to Reuters, the information will become part of an investigation into how Bernard L. Madoff Investment Securities LLC was run and how some of his investors' losses might be recovered.

Meanwhile, the Reuters article provided more details on a Congressional hearing on the Madoff scandal that is slated for January 5. As we reported earlier this week, House Financial Services Committee member Paul Kanjorski (D-PA) said in an email statement the hearing will “help us to discern whether or not the Securities and Exchange Commission had the resources needed to get the job done, how such a sizable scheme could have evaded detection for so long, and what new safeguards we need to put in place to protect investors.”

According to Reuters, SEC Inspector General David Kotz, who is probing the agency's oversight failures in the Madoff case, will be called to testify at the hearing. Harry Markopolos, the former chief investment officer at Rampart Investment Management who said he repeatedly tried to get the SEC to investigate Madoff, will also appear, Reuters said.

The SEC has faced a great deal of criticism over the Madoff scandal. According to The Washington Post, the SEC conducted routine examinations of the company in 1999, 2004, and 2005, as well as an investigation that ended in 2007. Only the 2005 examination found “minor problems”.

At least one investor has already brought a claim against the SEC for its role in the Madoff scandal. According to a report that appeared in Newsday last month, Phyllis Molchatsky, 61, of upstate New York, has filed an administrative claim against the SEC, accusing the regulator of “negligent conduct.” Molchatsky is seeking $1.7 million in damages from the SEC for allowing Madoff’s alleged Ponzi scheme to continue unchecked for at least a decade. If the SEC doesn’t respond to Molchatsky’s claim in six months, she can pursue her allegations against the agency in a federal court, Newsday said.

TVA Fly Ash Spill Could Bring Tougher Regulations

Fri, 02 Jan 2009 00:00:00 -0800

In the wake of last month's Tennessee fly ash spill, the governor of that state is promising more oversight of coal ash retention ponds. While touring the area around the Tennessee Valley Authority's (TVA) Kingston Fossil Plant were the spill occurred, Gov. Phil Bredesen said the adoption of tougher regulations for coal waste storage was long overdue.

The Tennessee fly ash spill occurred around 1:00 a.m. on December 22 after a wall holding back 80 acres of sludge from the TVA’s Kingston Fossil Plant in central Tennessee broke. Though the exact cause of the accident was not known, it was thought that six inches of rain over the previous 10 days and overnight temperatures in the teens contributed to the dam breach.

The TVA said that up to 400 acres of land had been coated by the sludge, making it 48 times larger than the 1989 Exxon Valdez spill in Alaska. The authority now says that 5.4 million cubic yards of potentially toxic fly ash was released from a retention pond. According to the Knoxville News, that’s triple the estimate of 1.7 million cubic yards the TVA released earlier this week. The fly ash spill damaged 15 homes. All the residents were evacuated, but at least three homes were deemed uninhabitable.

Earlier this week, the TVA warned residents in the area against drinking water from private wells or springs, as tests in the area showed high levels of arsenic. The TVA has also released an inventory of the toxic compounds that had been deposited into the coal ash retention pond during 2007. These include more than a million pounds of barium compounds, and tens of thousands of pounds of lead, manganese and arsenic compounds.

According to the Associated Press, on Wednesday, Bredesen promised that during the clean up of the spill, Tennessee environmental regulators would be closely watching the TVA. He also voiced hope that the spill would be a catalyst for change.

"The regulations we operate under now were written in the '70s; 2009 is a different world in terms of environmental regulation than the 1970s," Bredesen said at the time. The Governor also said the state had started immediate inspections of all other TVA retention ponds and a review of state regulations for the ponds, the Associated Press reported.

State officials are not the only ones asking questions about coal waste regulation. The Associated Press is also reporting that the U.S. Senate Environment Committee is scheduled to hear testimony next Thursday from TVA President and CEO Tom Kilgore, environmental advocates and local officials who responded to the disaster.

More Duragesic Pain Patches Recalled

Fri, 02 Jan 2009 00:00:00 -0800

Once again, Johnson & Johnson is recalling some Duragesic Pain Patches because of a defect that could cause patients to overdose on fentanyl. This is the second time in less than a year that Johnson & Johnson has recalled Duragesic patches. A similar action was issued by the company just last February.

The Duragesic and other similar pain patches are meant to treat persistent, moderate to severe chronic pain in opioid-tolerant patients 2 years of age or older. Fentanyl is a highly addictive opiate that is 80 times more potent than morphine. Fentanyl is considered a Class II substance by the Drug Enforcement Administration, meaning it is associated with a high potential for abuse and a risk for fatal overdose.

The most recent Johnson & Johnson patch recall involves one lot of Duragesic 50 mcg/hr patches under the lot number 0817239 sold by PriCara. The recall also includes one lot Sandoz Inc. 50 mcg/hr patches under the lot number 0816851.

PriCara is a division of Ortho-McNeil-Janssen Pharmaceuticals Inc., a unit of Johnson & Johnson. ALZA Corporation of Mountain View, CA, an affiliate of PriCara, manufactured the patches being recalled. A press release issued by PriCara said that other strengths of the patches, including 12.5, 25, 75 and 100 mcg/hr, are not affected.

In the press release, the company said it had identified a condition in manufacturing equipment that resulted in a cut-system defect in a small number of affected patches in the lots being recalled. The defect could result in a release of fentanyl gel from the gel reservoir into the pouch in which the patch is packaged, exposing patients or caregivers directly to fentanyl gel. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal, the release said.

PriCara is advising that anyone who has any of the recalled fentanyl patches should check the box or foil pouch to see if they have patches from the recalled lots. Cut patches should not be handled directly. Anyone who comes in contact with fentanyl gel should thoroughly wash exposed skin with large amounts of water only. Soap, alcohol, lotions, oils or other products to remove the medicine gel should not be used because they may increase the medicine's ability to go through the skin.

Patches with cut edges should be disposed of by flushing them down the toilet, using caution not to handle them directly. Patches with a cut edge that have leaked gel will not provide effective pain relief, PriCara said.

Last February, Johnson & Johnson recalled another 32 million Duragesic Pain Patches for a similar defect. At the time, the company estimated that about two out of every million patches could be defective.

In December 2007, the FDA issued an alert, warning patients and doctors that there was a high danger of accidental overdose associated with the use of fentanyl patches, including the Duragesic Pain Patch. At the time, the FDA attributed the overdoses to patch “misuse” and ordered all fentanyl patch makers to create special “medication guides” for patients that spell out the dangers of overdoses and improper use in easy-to-understand language.

The December warning marked the second time the FDA had cautioned the public about overdose dangers associated with products like the Duragesic Pain Patch. In July 2005, the FDA issued a Public Health Advisory announcing its investigation of “death and other serious side effects involving overdoses” in patients using both the Duragesic painkilling patches and their generic competitors. At that time, the FDA said it had received 120 reports of deaths related to fentanyl pain patches. Between the 2005 and 2006 warnings, the FDA apparently received many more reports of accidental overdoses associated with the Duragesic Pain Patch, but declined to say how many.

Innohep Alternatives Urged After Study Finds Increased Risk of Death in Elderly

Fri, 02 Jan 2009 00:00:00 -0800

Innohep, a drug used to prevent blood clots, may increase the risk of death for elderly patients. The Food & Drug Administration (FDA), along with Innohep manufacturer Celgene, have warned doctors to consider alternatives.

Innohep was approved for U.S. sales in 2000. It is injected under the skin, and is used with warfarin to treat blood clots that have occurred deep in the veins of hospitalized patients who may or may not have also experienced the occurrence of blood clots in their lungs. Innohep is used for several days after surgery, while a patient is unable to walk. It is during this time that blood clots are most likely to form. Innohep also may be used for other conditions as determined by a doctor. Since 2001, more than 30 million people worldwide have been treated with Innohep.

In early December, the FDA announced it had begun conducting a safety review of Innohep. The FDA decided to conduct the review after information about a clinical study known as Innohep in Renal Insufficiency Study (IRIS) that was stopped in February 2008. The study’s Data Safety Monitoring Committee had halted the IRIS trial because of an interim finding of an increase in all-cause mortality in patients who received Innohep. This multi-center European study was designed to evaluate the safety of Innohep, a low-molecular-weight heparin, compared to unfractionated heparin in treating deep vein thromboses (DVT) and/or pulmonary emboli (PE) in patients greater than 70 years of age who had impaired renal function.

At the time the study was stopped, 350 patients had completed 90 days follow-up. Of these, 23 of the 176 (13%) patients in the Innohep treated group and 9 of the 174 (5%) patients in the unfractionated heparin treated group had died. The FDA said that from the information currently available, there is no clear pattern as to the causes of death. The causes of death do not appear to be related to either over-dosing (bleeding) or under-dosing (blood clots) with an anti-coagulant (a blood thinner), the FDA said.

According to a "Dear Health Care Professional" letter recently issued by Celgene, information from the IRIS study has been added to the Innohep label under the "CLINICAL PHARMACOLOGY, Special Populations, Elderly", "WARNINGS" and "PRECAUTIONS, Geriatric Use" sections. The "ADVERSE REACTIONS" section of the Innohep label has also been updated to include the statement “Spinal epidural hematoma in association with neuraxial anesthesia or spinalpuncture with INNOHEP has been reported."

According to the FDA, there have been 383 reports of Innohep side effects and complications worldwide, including 96 deaths, as of Oct. 15, 2008. The Celgene letter recommends that doctors consider alternatives to Innohep in patients with deep vein thrombosis, life-threatening blood clots in major veins such as in the legs.

According to the Associated Press, Celgene sent another letter to doctors in July warning of an elevated risk of death in patients aged 90 and older. The new letter extends the warning to all elderly patients.

Antioxidant Supplements Don't Cut Cancer Risk

Wed, 31 Dec 2008 00:00:00 -0800

Antioxidant supplements do not offer any advantage in the fight against cancer according to a study conducted at Harvard Medical School and published in the Journal of the National Cancer Institute. This is just the latest study to question claims made by the makers of dietary supplements.

The nearly decade-long study—The Women’s Antioxidant Cardiovascular Study—involved 7,627 women taking beta carotene, vitamin C, or vitamin E in combination or individually over 9.4 years said Reuters. The study revealed that, despite taking supplements, the women experienced no meaningful decrease in cancer risk over women who did not take supplements, reported Reuters, which noted that Dr. Jennifer Lin and colleagues conducted the clinical trial.

Medical News Today pointed out that the “randomized, double-blind, placebo-controlled” study also included researchers from Brigham and Women’s Hospital and that while this study did not reveal a link between vitamins—antioxidants—and a reduction in cancer incidence, a variety of observational studies have linked diets high in fruits and vegetables with cancer prevention. "Simply taking antioxidant supplements is insufficient to prevent cancer development," said study lead author Jennifer Lin, an assistant professor of medicine at Harvard Medical School, adding that eating fruits and vegetables rich in nutrients such as antioxidants, is still a good idea, according to Health Day News. This is not the first time such a study has been unable to link supplements with cancer prevention, WebMD News noted. Last month, similar results were derived from a study with male doctors taking either vitamin C or E, said WebMD News.

The 7,627 women in the recent study were cancer-free at the start of the research, said Medical News Today, and were part a larger 8,000-women group in which the women were randomly assigned to take either 500 mg of ascorbic acid—vitamin C—daily, a “natural source of vitamin E—600 IU of {alpha}-tocopherol—every other day, 50 mg of beta-carotene every other day, all three supplements, or a placebo. The women all had or were at risk for cardiovascular disease, were over 40 years of age, and participated in the study from 1995 and 1996 until 2005—said Health Day News, which added that during the study, 624 women developed cancer and 176 died from cancer, leading the researchers to conclude that there was no "statistically significant" evidence that the supplements had any effect on a woman’s cancer risk.

Reuters reported that the risks were nearly the same in the vitamin C, the vitamin E, and the beta carotene group, with little difference in death risk in any one group; however, the risk was 28 percent higher in the vitamin C group, 13 percent lower in the vitamin E group, and 16 percent lower in the beta carotene group. "We observed no overall associations of the three antioxidant supplements, taken singly or combined, with total cancer incidence or mortality. Duration of supplementation also did not appear to alter the associations of these supplements with risk of cancer or mortality due to cancer," Lin and her colleagues wrote, said Reuters.

Also according to Reuters, Dr. Demetrius Albanes of the National Cancer Institute in Bethesda, Maryland discussed in an editorial on the study that two findings from the study "deserve additional mention." It seems that vitamin E helped protect against colorectal cancer while beta carotene increased lung cancer risks, reported Reuters, which mirrors existing knowledge, noted Medical News Today.

Biovail Recalls Ultram Painkiller

Wed, 31 Dec 2008 00:00:00 -0800

Some lots of Ultram® ER 100mg tablets are being recalled. Toronto-based pharmaceutical company Biovail Corporation is voluntarily recalling some lots of the painkillers—generically known as extended-release tramadol hydrochloride—from pharmacies and wholesalers after finding that certain batches were found to be “out-of-specification” by about one percent regarding “maximum dissolution at the eight-hour mark,” said Fierce Biotech.

The specification variance concerns the rate at which the medication dissolves. RTT News explained that that Ultram uses a so-called “Smartcoat” technology that is designed to release the once-daily pain medication throughout the day.

The Canadian Press pointed out that an unspecified amount of Ultram ER tablets are involved in the recall; however the recall will likely reduce quarterly revenue by $4.4 million (U.S.) and add $3 million (U.S.) to inventory and administrative costs. Biovail said, according to the Canadian Press, that the recall "does not impact patient health or safety," and no product shortages are expected at the drugstore level.

It seems, said Biovail, that the Ultram ER problem stems from “excipients,” so-called inactive ingredients used to carry medicines’ active ingredients, according to the Canadian Press. In this case, explained Biovail, the excipients were used in the coating process and "corrective measures are currently being implemented," reported the Canadian Press, which also pointed out that replacement shipments will be made to Biovail’s marketing partner, PriCara, which is a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

Tramadol is a synthetic, prescription pain reliever that is similar to morphine in that it binds to opioid receptors in the brain to stop the sensation of pain, according to MedicineNet, which describes the most common side effects reported with Tramadol as being nausea, constipation, dizziness, headache, drowsiness, and vomiting; itching, sweating, dry mouth, diarrhea, rash visual disturbances, and vertigo have been reported, as have been seizures. Anxiety, sweating, insomnia, rigors, pain nausea, diarrhea, tremors, and hallucinations can occur when tramadol is abruptly stopped, MedicineNet warns.

Ultram is used in cases of moderate to moderately severe chronic pain in adults, who need ongoing pain management for extended time frames, said RTT News.

Metrolink Crash Lawsuits Filed

Wed, 31 Dec 2008 00:00:00 -0800

Following the fatal Metrolink train crash that killed 25 people and injured 138, seven lawsuits have been filed. Officials said 220 people were aboard the commuter train on September 13, which was heading from Union Station in downtown Los Angeles to Ventura County, when it ran head-on into a Union Pacific freight train traveling in the opposite direction. According to the National Transportation Safety Board (NTSB), the Metrolink train’s engineer failed to stop at the final red signal, which forced the train onto a track where the Union Pacific freight was traveling.

KeyT3 reported that the seven lawsuits were filed this week in Los Angeles Superior Court on behalf of the victims of the deadly September 12 Metrolink collision. Two lawsuits allege negligence and wrongful death and seek unspecified damages, said KeyT3, which reported that two lawsuits name the following defendants: The regional rail authority that operates Metrolink, several contract companies, and the Los Angeles County Metropolitan Transportation Authority. The other suits, which seek a jury trial and general damages, name Connex Railroad—a contractor that provides engineers who run the Metrolink trains—as well as Veolia Transportation—Connex’s parent company—and the train engineer’s estate.

Federal investigators confirmed the engineer was texting on his cellphone seconds before the crash. The last message the engineer received was at 4:21:03, more than one minute prior to impact; the final message he sent was at 4:22:01, just 22 seconds before the trains collided. Both trains were traveling at about 40 miles an hour.

Following the tragedy, the Federal Railroad Administration (FRA) issued an emergency order prohibiting all train operators from using cell phones while on duty. And, while the rule was issued in October, it comes years after the FRA first considered the matter, two weeks after the California Public Utilities Commission imposed the same restriction, and one day after the NTSB issued a preliminary report saying text messages were sent and received by Metrolink engineer Robert M. Sanchez's cell phone in the moments before his commuter train collided with the Union Pacific freight train. The FRA’s emergency order also contains a list of recent train accidents that involved cell phone use including one accident that occurred over the summer when a Union Pacific brakeman walked across tracks while talking on his cell phone; he was struck and killed by a train. Another accident involved a 2006 head-on collision in Texas between two Union Pacific freight trains. In that case, the FRA later determined that the engineer was talking on his phone and not paying attention.

Of note, the Senate recently approved—in a 74 to 24 vote—a rail-safety bill sponsored by California’s senators, Dianne Feinstein and Barbara Boxer. The bill was approved in the House and requires major railroad and commuter lines to install collision avoidance systems, including automatic braking, by December 31, 2015. The last time Congress addressed railroad safety was in 1994, when it passed the Federal Railroad Safety Authorization Act, but that law expired in 1998. Critics say Congress has neglected railroad safety and that the FRA has been less-than enthusiastic about new reforms and is deferential to industry.

Evenflo Recalls Nearly 100K High Chairs

Wed, 31 Dec 2008 00:00:00 -0800

EvenFlo is recalling about 95,000 Majestic™ High Chairs. The U.S. Consumer Product Safety Commission (CPSC) recently announced the recall citing fall and choking hazards to children.

The Evenflo Company of Miamisburg, Ohio is recalling the nearly 100,000 Majestic™ High Chairs because the plastic caps and metal screws on both sides of the high chair can loosen and fall out, posing both fall and choking hazards to children and can cause the seatback to suddenly fall back or detach from the high chair. Children can fall out or collide with objects and suffer broken bones, abrasions, cuts, and bruises and the detached plastic caps and metal screws pose a choking hazard to children. Justice News Flash notes that in addition to causing injuries, the detached plastic and metal pieces have also reportedly been found in toddlers hands posing a choking hazard.

To date, said the CPSC, Evenflo has received 140 reports of seatbacks reclining, falling back, and/or detaching unexpectedly, which resulted in at least 47 reports of bumps and bruises to the head; two reports of broken bones; and at least 45 reports of other injuries including abrasions, cuts, and bruises. Also, Evenflo has received over 1,000 reports of plastic caps and screws falling out of the high chairs, including seven incidents in which caps and screws were found in children’s hands or mouths.

The recall involves Evenflo Majestic™ high chairs manufactured in China before January 23, 2007 with model numbers 3001395A, 3001583, 3001633A, 3001669, 3001700A, 3001713, 3001713A, 3001730A, 3001732, 3001732A, 3001733, 3001742, 3001742A, and 3001756. The model number and production date are on the seatback’s white; “Evenflo” is printed on the label and the push button on the front of the tray. The recalled Evenflo Majestic™ High Chairs were sold at juvenile product and mass merchandise stores nationwide, including Toys R Us, Babies R Us, Burlington Coat Factory, and Shopko, and on-line at Walmart.com from January 2006 through May 2007 for $80-$110. The CPSC is warning consumers to immediately stop using the high chairs and contact Evenflo to receive a free repair kit at (800) 233-5921 between 8:00 a.m. and 5:00 p.m. ET Monday through Friday, or at the firm’s Website at www.majestichighchair.com.

This is not the first time EvenFlo has been involved in a massive recall. Earlier this year, Evenflo recalled one million of its Discovery Infant Car Seats after tests conducted by the National Highway Traffic Safety Administration (NHTSA) revealed that the Discovery Infant Seat could potentially become separated from its base in high impact side collisions. Last year, 450,000 Evenflo Embrace Infant car seat/carriers—manufactured in the United States and China—were recalled due to malfunctioning handles.

In that case, Evenflo received 679 reports of handles unexpectedly releasing and 160 injuries to children including a skull fracture, two concussions, cuts, scrapes, and bruises. This is also not the first time high chairs made in China have been involved in recalls over potential injuries. Last year, Graco Children’s Products Inc. announced the recall of 100,000 highchairs because they could collapse if not fully opened and locked into place from the storage position. In that case, Graco received 18 reports of the chair collapsing and one report of a baby being injured.

Plavix Label Changes Could be On the Way

Wed, 31 Dec 2008 00:00:00 -0800

Plavix, a popular anti-clotting drug, could soon have new information added to its label detailing genetic factors that might inhibit its effectiveness. According to The Wall Street Journal, the Food & Drug Administration (FDA) is considering the changes after various studies showed Plavix failed to work in nearly a third of the cardiac patients who used it.

Plavix is used to prevent blood clots after a recent heart attack or stroke, and in people with certain disorders of the heart or blood vessels. The medication keeps the platelets in the blood from coagulating to prevent unwanted blood clots that can occur with certain heart or blood vessel conditions.

There is no way for doctors to measure how well Plavix is working. Generally, if patients avoid another heart attack or stroke, it is thought to be effective. But according to The Wall Street Journal, medical literature on Plavix has shown heart patients suffered cardiac events even though they were taking the drug regularly, but no one understood why.

According to the Journal report, studies in two studies published in the New England Journal of Medicine and another in Lancet last week identified a genetic abnormality in some heart patients that could interfere with their liver's ability to completely process Plavix in the bloodstream. Two of the studies suggested the drug was less effective in about 30% of the population, but the third put the risk at only 5%.

That uncertainty is apparently causing problems for the FDA. The Journal said the agency is having trouble deciding just what type of labeling changes to make to Plavix, as well as what guidance should be given to doctors.

Right now, the FDA is thinking about adding a recommendation to Plavix that patients undergo genetic testing before starting it. But for patients with the genetic abnormality, there are no easy answers. According to the Journal, increasing the dosage of Plavix can increase the risk of internal bleeding. Unfortunately, right now there are no alternatives to Plavix available in the U.S.

$28 Mil of Bernard Madoff's Assets Transferred to Bankruptcy Trustee; More Lawsuits Loom

Wed, 31 Dec 2008 00:00:00 -0800

A federal bankruptcy judge has approved a transfer of $28 million in assets held by alleged Ponzi schemer Bernard Madoff to the trustee overseeing the case. The funds will be used to pay for the administrative costs related to the liquidation of Madoff's business. Meanwhile, as more investors filed lawsuits seeking to recover money they lost as a result of his alleged investment fraud, Madoff faces a year-end deadline to furnish federal regulators with a list of his personal assets.

The 70-year-old Madoff was arrested on one count of securities fraud on December 11. Madoff - once a chairman of the Nasdaq stock exchange - is the founder and primary owner of Bernard L. Madoff Investment Securities LLC. The firm is primarily known for its business in market-making, or serving as the middleman between buyers and sellers of shares. However, Madoff also oversaw an investment-advisory business that managed money for high-net-worth individuals, hedge funds and other institutions.

According to the FBI complaint against Madoff, that business was largely a Ponzi scheme. The FBI said Madoff “deceived investors by operating a securities business in which he traded and lost investor money, and then paid certain investors purported returns on investment with the principal received from other, different investors, which resulted in losses of approximately billions of dollars.” Madoff reportedly told employees that his fraud could cost investors as much as $50 billion.

Shortly after Madoff's arrest, a federal judge ordered that his business be liquidated under the jurisdiction of a bankruptcy court and assigned a trustee to oversee that process. According to CNN.com, court papers filed in that bankruptcy indicate that Bank of New York Mellon Corp. has agreed to transfer the $28 million in assets to the trustee overseeing the liquidation. The court papers also said that $883,000 had already been transferred to the trustees to pay employees' salaries and health care benefits.

CNN said the funds are needed to pay employee salaries and other costs. Some of the assets could also be sold off to recover money for investors, CNN said.

Meanwhile, three residents of Massapequa Park, New York became the latest angry investors to file suit against Madoff in Manhattan federal court. According to Bloomberg.com, Anthony, Maria and Toni Sciremammano claim to have been investing with Madoff since 1995, and by September had invested a total of about $2 million. In addition to asking for $2 million in damages, the plaintiffs are also seeking to have Madoff's assets permanently frozen so they cannot be transferred to his family and friends.

Investors like the Sciremammanos might soon have a better idea about the value of Madoff's assets. According to the Associated Press, Madoff is scheduled to submit a list of his personal assets to the Securities and Exchange Commission by the end of the year. The list is to include what property that could be sold to make restitution to victims of his alleged fraud, the Associated Press said. Madoff's lawyer told the Associated Press that his client intends to meet that deadline.

Tennessee Fly Ash Spill Lawsuit Seeks $165 Mil From TVA

Wed, 31 Dec 2008 00:00:00 -0800

A developer is the first Tennessee landowner to file a lawsuit against the Tennessee Valley Authority (TVA) for last week's devastating fly ash spill. The lawsuit is seeking $165 million in damages from the TVA.

The Tennessee fly ash spill occurred around 1:00 a.m. last Monday morning after a wall holding back 80 acres of sludge from the TVA’s Kingston Fossil Plant in central Tennessee broke. Though the exact cause of the accident was not known, it was thought that six inches of rain over the previous 10 days and overnight temperatures in the teens contributed to the dam breach.

The TVA said that up to 400 acres of land had been coated by the sludge, making it 48 times larger than the 1989 Exxon Valdez spill in Alaska. The authority now says that 5.4 million cubic yards of potentially toxic fly ash was released from a retention pond. According to the Knoxville News, that’s triple the estimate of 1.7 million cubic yards the TVA released earlier this week. The fly ash spill damaged 15 homes. All the residents were evacuated, but at least three homes were deemed uninhabitable.

Earlier this week, the TVA warned residents in the area against drinking water from private wells or springs, as tests in the area showed high levels of arsenic. The TVA has also released an inventory of the toxic compounds that had been deposited into the coal ash retention pond during 2007. These include more than a million pounds of barium compounds, and tens of thousands of pounds of lead, manganese and arsenic compounds.

Developer Jot Raymond and his wife Brenda were among the property owners whose land was damaged by the fly ash spill. Their lawsuit, which was filed in Roane County Circuit Court, says that coal ash sludge from the retention pond spilled into their North Lake Estates development, causing two home sales to fall through. The suit claims a creek running through the development has been damaged and is backed up as a result. According to CNN.com, Jot Raymond said he has not been allowed to take potential buyers into the subdivision for showings or visit his daughter who lives there.

"TVA possessed or reasonably should have possessed knowledge and data which indicated the retention pond was subject to collapse or breach," the lawsuit says.

The Raymonds are seeking 15 million in compensatory damages and $150 million in punitive damages. TVA, its board of directors, President and CEO Tom Kilgore and other TVA executives are named as defendants.

Group Urges Study of Phthalates

Tue, 30 Dec 2008 00:00:00 -0800

A report by the National Research Council is calling on the U.S. Environmental Protection Agency (EPA) to look at phthalates and their effects on human health, reports Science Daily. A National Research Council panel said that there is now sufficient scientific data to warrant an EPA assessment on cumulative exposure to the toxic, plastic-softening chemicals, reported Reuters.

The panel said so-called Cumulative Risk Assessment should consider combined phthalate exposure as well as other toxins that cause similar effects, reported Science Daily. The report noted that currently, the EPA looks at chemicals that are similar in structure and not similar health effects. In looking at effects, the EPA could also investigate the risk of combined exposures to toxins such as lead, methylmercury, and polychlorinated biphenyls since all are known to contribute to the same effect: Cognitive deficits linked to reduced IQ scores in children. Because of this type of correlation, the National Research Council suggested the EPA use the cumulative analysis approach for future assessments on other chemicals, said Science Daily.

Science Daily also explained how the Cumulative Risk Assessment was determined, noting that two factors are critical: If humans are exposed to multiple phthalates at any given time, and if sufficient evidence exists linking exposures to similar adverse health effects. In this case, the committee concluded that such studies indicate broad human exposure—including in utero—to multiple phthalates.

Some phthalates are among the chemicals banned in the recently passed Consumer Product Safety Commission Improvement Act, which comes into effect February 2009. The Act, which bans three phthalates in children’s toys and products in all but the smallest of amounts—and, pending additional research, bans three other phthalates—has been under fierce scrutiny because some manufacturers and retailers are using the window between the holiday season and the deadline to manufacture and sell toxic toys, which was not the Act’s intent. The same six phthalates included in the Act, have been banned for almost ten years in European toys, Reuters said. According to Science Daily, the European Union (EU) also banned some phthalates from cosmetics and has bans in place similar to the pending U.S. ban. Science Daily noted that phthalates are used in a wide variety of products including cosmetics, medical devices, toys, and building materials.

Phthalates, which have been in use for decades, make plastic products soft and have been linked to hormonal disturbances and a variety of other adverse effects, making headlines in recent months over their continued use—especially in products and toys meant for children—despite links to physical harm. Phthalates can be found in soft plastic toys and children’s products, including rubber ducks, teethers, and pacifiers. Reuters added that phthalates have also been used in personal-care products, food packaging, pharmaceuticals, and cleaning materials. Science Daily points out that recent animal studies have revealed the potential risks from phthalates; the committee reviewed this research and concluded that exposure to various phthalates in lab animals produced similar health outcomes, including effects on the development of the male reproductive system such as infertility, undescended testes, penis and other reproductive tract malformations, and reduced testosterone levels.

Chinese Honey Latest Food Safety Worry

Tue, 30 Dec 2008 00:00:00 -0800

Honey is the latest Chinese food import to raise safety worries in the United States, reports the San Francisco Gate. According to the report, the United States has imported the majority of its honey from China for years, despite concerns that it might be contaminated with a dangerous antibiotic.

Over 10 years ago, in 1997, a contagious bacterial epidemic infected bee larvae in hundreds of thousands of Chinese hives, resulting in the majority of that country’s honey production being cut by two-thirds, said the SF Gate. The report explains that while Chinese beekeepers could have destroyed the infected hives, they, instead, applied a dangerous, extremely toxic, banned antibiotic. According to Michael Burkett, professor emeritus at Oregon State University and an international bee and honey expert, this was the wrong choice, "You hear about people shooting themselves in the foot? Well, the Chinese honey-sellers shot themselves in the head," he told the SF Gate.

The problem is that China used a cheap, broad-spectrum antibiotic called chloramphenicol, to treat its hives; chloramphenicol is considered so toxic it is only used in the most serious of infectious cases in humans and only when all other alternatives have been exhausted, said the SF Gate. "That's on the big no-no list," Burkett said, adding that, "In the U.S., Canada, and the European Union, chloramphenicol is on everyone's zero-tolerance list." Regardless, the Chinese chose to dose its hives with the dangerous drug and now, those honey buyers who test for it, find the banned antibiotic in the imported honey, said the SF Gate.

The U.S. Food and Drug Administration (FDA) says tainted Chinese honey is high on its watch list. According to the SF Gate report, the FDA considers a food adulterated if it contains an animal drug deemed unsafe for unapproved uses. Chloramphenicol is such a drug and is illegal in food-producing animals, including bees, in the U.S.

In 2005, China's Ministry of Agriculture banned the drug in food production; however, it seems that Chinese beekeepers are violating the ban, said the SF Gate. It is impossible to determine safe residue levels for the toxic drug, Steve Roach, public health director of Keep Antibiotics Working, told SF Gate. "If the Chinese authorities are unable to keep this drug from being used, then no imports of honey from China should be allowed," he said.. The FDA says chloramphenicol has been linked to aplastic anemia, a serious blood disorder, said SF Gate.

Meanwhile, Seattle PI wrote about its investigation into the growing trend in honey trafficking. Because U.S. bee colonies are dying off, import demand has increased, with traders looking to bypass tariffs and health safeguards by diluting honey or tainting the product with pesticides and antibiotics, said Seattle PI. China is known to “transship,” or launder the honey in other countries to avoid U.S. import fees and tariffs on imports that intentionally lowball domestic prices. Seattle PI noted that honey from China comes to the U.S. as being falsely labeled as tariff-free from Russia, or from countries that have small bee populations or no known export production. According to Seattle PI, only a small fraction of honey imported into the U.S. is inspected and the U.S, government has not legally defined honey, posing challenges for enforcement agents working to keep tainted honey out of the country.

ER Workers Often Infected with MRSA

Tue, 30 Dec 2008 00:00:00 -0800

Two new reports released by the Annals of Emergency Medicine have concluded that health care workers in emergency departments—so called ERs or EDs—of hospitals are often found to carry a dangerous infectious bacteria, said Reuters. MRSA, or methicillin-resistant Staphylococcus aureus, seem to be much more prevalent in this population than first thought, putting untold numbers of patients at risk for the often dangerous, sometimes deadly infection, Reuters pointed out.

It has long been known that health care workers test positive for MRSA from time to time; however, the two new studies found that the incidence is much more frequent, placing the health care workers deep into the MRSA mix according to Dr. Elise O. Lovell from Advocate Christ Medical Center, Oak Lawn, Illinois, said Reuters Health. In the first study, Lovell and her colleagues found that, based on nasal swab testing from a sampling of 105 emergency department staff at Advocate Christ Medical center, 16 staff—or 15 percent—tested positive for MRSA and included 12 nurses, two technicians, and two doctors, reported Reuters.

In the second study, Dr. Brian P. Suffoletto and colleagues from the University of Pittsburgh Department of Emergency Medicine looked at 255 emergency department health care workers and found that nearly one-third—31.8 percent—of the nasal cultures tested positive for S. aureus, with MRSA showing up in 4.3 percent of the cases. "The varying prevalence among the different health care workers was unexpected," Suffoletto told Reuters Health.

In an earlier report conducted by Newsday, Dr. Susan Donelan, a specialist in adult infectious diseases at Stony Brook University Medical Center, told Newsday.com that, “about 30 percent of the population carries Staphyloccoci.” Both Lovell and Suffoletto urged proper infection control practices be routinely followed in ERs. "It's been demonstrated repeatedly that these hygiene techniques are poorly followed in the ED, yet they represent the best (and simplest) way to minimize the spread of MRSA between our patients and to keep our patients and ourselves safe," Lovell told Reuters.

The U.S. Centers for Disease Control and Prevention, Atlanta (CDC) explains that MRSA can be transmitted through direct skin-to-skin contact and usually begins with a small pustule or boil. According to the CDC, all MRSA infections can be treated early with drainage and antibiotics. If not treated early, MRSA can lead to pneumonia, bloodstream, or bone infections that can prove serious and sometimes deadly.

According to the Mayo Clinic, MRSA is caused by the Staphylococcus aureus bacteria, or staph, and is a strain that is now resistant to broad-spectrum antibiotics. The Mayo Clinic also points out that the majority of MRSA infections originate in hospitals or other health care settings (health care-associated MRSA, or HA-MRSA). However, another type of MRSA has been emerging outside of health care settings (community-associated MRSA, or CA-MRSA) that includes serious skin and soft tissue infections and a serious form of pneumonia.

In the United States, there are approximately 95,000 serious infections and 20,000 deaths due to MRSA each year.

Judge Says FEMA Can Be Sued Over Trailers

Tue, 30 Dec 2008 00:00:00 -0800

Although U.S. District Judge Kurt Engelhardt refused to grant class-action status to the hundreds of toxic FEMA (Federal Emergency Management Association) trailer lawsuits, he did rule the cases must be presented on a case-by-case basis, reported the Washington Post. The judge also rule that FEMA was no immune from the lawsuits.

The lawsuits claim that Hurricane Katrina and Rita victims were exposed to potentially toxic fumes while living in the Toxic FEMA trailers, said CBS News. Attorneys representing plaintiffs in the suit claim trailer makers used substandard “products and methods,” reports The Washington Post.

Last year, it was discovered that the toxic FEMA trailers were emitting far more poisonous formaldehyde than first believed and, according to air quality test conducted by the Sierra Club, as many as 95 percent of occupied Toxic FEMA trailers used by Rita and Katrina hurricane victims contained twice the level of formaldehyde fumes considered safe by the Centers for Disease Control and Prevention (CDC). What’s more, the same air quality testing found unsafe levels of formaldehyde in FEMA mobile homes, which were once thought to be a safe alternative to the Toxic FEMA trailers.

Although plaintiffs' attorneys argued that a class-action suit would best resolve the multi-state cases, The Washington Post reports Engelhardt ruled that because the lawsuits name hundreds of different types of trailers manufactured by a variety of companies, and involve numerous people with differing and various medical histories and complaints, the cases must be handled individually. "Each plaintiffs' claims and alleged injuries will require an examination of individual evidence," Engelhardt wrote in a nearly 50-page ruling, said CBS News.

After Hurricane Katrina, FEMA purchased nearly 2,000 travel trailers at a cost of $2.6 billion. Some residents lived for months for their trailers only to discover the cheap building materials used were emitting toxic formaldehyde vapors. The lungs of young children can be extremely damaged from these toxic vapors and many people reported not being able to stay in their trailers for more than five minutes without experiencing burning eyes, coughing, headaches, nausea or skin rashes, sinus infections, and nosebleeds. Formaldehyde is also a known carcinogen.

CBS News said its chief investigative correspondent spoke with employees on trailer production lines who knew about the formaldehyde problem. "We were instructed to open the doors and windows so that the odor wouldn't be as strong when the FEMA inspectors got there," one worker told CBS. CBS also said the CDC tested air quality in hundreds of the Toxic FEMA trailers and found formaldehyde levels were about five times higher than what is in most “modern” homes.

In his ruling, Engelhardt referred to evidence that revealed FEMA delayed its investigation over concerns of legal culpability, noting that FEMA knew of the problem sometime around March 2006. But according to the Associated Press, Engelhardt's ruling said,, FEMA stuck “their heads in the sand” and did not order testing on air quality. "Indeed, the evidence shows that FEMA initially ignored the potential formaldehyde problem and neglected to conduct testing in fear that such testing would imply FEMA's ownership of the issue," his decision said.