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Some Products Exempt From Lead Rules

Wed, 07 Jan 2009 00:00:00 -0800

The U.S. Consumer Product Safety Commission (CPSC) just voted to exempt some lead-laden electronic goods and products from the recently enacted Consumer Product Safety Improvement Act (CPSIA). The Act comes into effect next month, but the CPSC is looking to remove certain lead-containing electronic goods, among other items, from the lead toy ban, reports Bloomberg News. The ban on lead in toys becomes effective next month on February 10th.

The Commission, comprised of two members, was responding to industry complaints said Bloomberg, and is also looking to release some natural products, such as wool, gems, pearls, and cotton, from the mandatory lead testing. Industry lobbyists, speaking on behalf of makers of “books, handheld computers, bedding, and shoes” hope to find exemption for the Act and are working to remove a variety of products—glass, bolts, and mattress padding, to name a few—that they feel present no risks to children, reported Bloomberg. The Commission’s proposal received initial approval this week and is open for public comment for one month, said Bloomberg. Industry had been looking for more expansive and immediate exemptions to the approaching law, added Bloomberg.

In 2007, over six million toys were recalled because of lead; the highest number ever due to product defects; Mattel Inc. alone recalled twenty-one million toys. Lawsuits over lead in toys include cases with Fisher-Price; Michaels Stores; Sears, Roebuck and Co.; Costco Wholesale; Eveready Battery; KMart; and Marvel Entertainment for Ernie, Elmo, Big Bird, SpongeBob, and Thomas the Train products. Potentially dangerous toys remained on store shelves several times during that year and by the time that year’s holiday season hit—the busiest selling time for toy companies—the CPSC had recalled 75 brands of toys. Of those, 39 recalls were implemented due to lead exposure.

In children and fetuses, lead exposure can cause brain and nervous system damage, behavioral and learning problems, slowed growth, hearing problems, headaches, mental and physical retardation, and behavioral and other health problems. Lead is also known to cause cancer and reproductive harm and, in adults, lead can damage the nervous system. Once poisoned by lead, no organ system is immune. Unfortunately, lead poisoning is difficult to recognize because it manifests with subtle symptoms and there are no definitive indicators that point to contamination. When faced with peculiar symptoms that do not match any one particular disease, lead poisoning should be considered.

Finally, last year, Congress passed the first overhaul to consumer protection laws in about 20 years, mostly over the glut of recalled Chinese-made lead-tainted toys, said Bloomberg. The Act strengthens and expands the existing lead standard and mandates that chidren’s product and toy makers obtain independent testing to ensure products are lead-free, Bloomberg noted.

Now, in the days before the Act takes effect, manufacturers are looking for ways to skirt the mandates and avoid lead testing in a wide variety of products. Many experts agree that lead in any amount is dangerous to children, fetuses, and adults and many consider lead poisoning to be one of the most important chronic environmental illnesses affecting children today. Despite efforts to control lead, serious cases still occur.

FDA to Require Foods, Cosmetics to List Bug Dye Linked to Allergies

Wed, 07 Jan 2009 00:00:00 -0800

Color additives made from insects will have to be listed on food and cosmetics labels by 2011. Right now, when the bug dyes are listed on the packaging of food and cosmetics, they are simply listed as “artificial color,” said the Free Press News Service, which noted that the change in description came about over reports of allergic reactions and a decade-old petition filed by a consumer advocacy group.

Although the labeling will be revised in two years, it will not indicate that bugs are involved in affected products’ manufacture, notes Free Press News, which explained that, instead, products will simply list carmine and cochineal extract. The Food & Drug Administration's (FDA) new rule becomes effective on January 5, 2011, said WebMD.

These dyes are derived from dried cochineal bugs and eggs and are used in "dozens of reddish-colored foods and beverages, including fruit drinks, ice creams, yogurts, and candies," states a news release from the nonprofit Center for Science in the Public Interest (CSPI). The CSPI petitioned the FDA over 10 years ago to ban the extracts but has been unable to create a complete list of products containing the bug-derived coloring, said The Palm Beach Post.

The extracts create bright red, pink, and magenta pigments and come from the carminic acid that some female insects from the cochineal family produce and are used to make artificial flowers; paints and inks; cosmetics, such as blush; and food additives. Cochineal can be bright orange, said the Palm Beach Post, which said its purer form—carmine—is “vivid” red, but it can be found in purple or pink colorings. Bloomberg News further explains that carmine is a crimson or purplish-red, while cochineal is red.

Bloomberg News noted that the insects are used in Estee Lauder Company and Clinique make-up and some Dannon yogurts, which, in some cases, do list the ingredients by name. The Palm Beach Post said to also be on the lookout for other products containing the bug extracts including waffles, lipstick, strawberry milk, candy, shampoo, and nail polish and quoted CSPI’s Executive Director Michael Jacobson as saying that the extracts “can be” in “anything red."

Although the FDA says it does not consider carmine and cochineal extracts to be “major” food allergens, it did note that some of the allergic reactions were severe and included anaphylaxis among the responses reported, WebMD said. The FDA explained that its final rule was a response to “reports of severe allergic reactions,” including the life-threatening and often fatal, anaphylaxis, and was also responding to CSPI’s submission of a citizen petition. Drawing from FDA information, the Palm Beach Post said that one girl broke out in hives, one woman was hospitalized for five days, and another woman experienced difficulty breathing after consuming red-dyed food products.

Under the new rules, labels will not be required to indicate that the extracts are potential allergens. WebMD said food and cosmetic manufacturers may indicate the extracts by name on products in advance of the new rule becoming effective in two years. Jacobson said in a news release that while the FDA’s rule is “useful progress” the agency “should have exterminated these critter-based colorings altogether," reported WebMD.

Dozens of Medtronic Sprint Fidelis Lawsuits Dismissed

Wed, 07 Jan 2009 00:00:00 -0800

Even while acknowledging that Medtronic Inc.'s defective Sprint Fidelis defibrillator lead caused serious injuries to plaintiffs, a federal judge yesterday dismissed dozens of Sprint Fidelis lawsuits on the grounds of preemption. Preemption is a legal doctrine that federal regulation of a product - such as a medical device - bars lawsuits filed under state law.

Medtronic suspended sales of its Sprint Fidelis Leads in October 2007, after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with Sprint Fidelis Leads were told to leave the defective components in place unless they fracture.

Before the recall, Sprint Fidelis leads had been implanted with 90% of Medtronic’s defibrillators. According to the Wall Street Journal, 268,000 defective Sprint Fidelis Leads had been implanted worldwide, and about 235,000 people still had these leads in their chests when the recall was issued. Not surprisingly, the Sprint Fidelis recall spawned scores of personal injury lawsuits.

Last February, the Supreme Court ruled in a case called Riegel vs. Medtronic (which did not involve the Sprint Fidelis lead) that the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act that require Food & Drug Administration (FDA) approval of medical devices preempt product liability lawsuits in state courts. That law clearly says that states can’t maintain requirements that are different from federal standards. But Congress didn’t specify if those federal standards preempted state common law claims.

Medtronic and the Bush Administration asserted that allowing state personal injury lawsuits against the makers of defective medical devices amounts to a state “requirement” different from FDA requirements because such complaints are based on state laws. Eight members of the high court agreed with Medtronic. The Court recently heard another case, Wyeth vs. Levine, that could extend a similar lawsuit shield to drug makers.

But the doctrine of preemption is a controversial one, and many believe it puts patients at risk. In an Amicus Brief filed in Wyeth vs. Levin, the editors of the New England Journal of Medicine said the FDA ‘’is in no position'’ to guarantee drug safety, and that product liability lawsuits can serve as ‘’a vital deterrent'’ and protect consumers if drug companies don’t disclose risks.

In a ruling yesterday, U.S. District Judge Richard H. Kyle dismissed dozens of Sprint Fidelis lawsuits. In his decision, the judge wrote that "the court recognizes that at least some plaintiffs have suffered injuries from using Sprint Fidelis leads, and the court is not unsympathetic to their plight. But plaintiffs assert claims for which the court simply cannot provide a remedy."

Judge Kyle also wrote that it was up to Congress to change the law that bars such lawsuits. That is something that could happen. According to The Wall Street Journal, Democrats in both houses of Congress have introduced bills to overturn the Riegel decision. President-elect Barack Obama, who would have to sign such a law once it was passed, was a co-sponsor of the Senate bill.

Bernard Madoff Mailed Cartier, Tiffany Watches, Other Expensive Jewelry to Family & Friends

Wed, 07 Jan 2009 00:00:00 -0800

Prosecutors seeking to have Bernard Madoff's bail revoked have filed court papers detailing items he attempted to mail to his sons and others. Prosecutors contend that the alleged Ponzi schemer violated a court order not to dispose of any assets by mailing the valuables. If Madoff's bail is revoked, he would be required to leave his posh Manhattan apartment - where he is under house arrest - for jail.

Madoff has been under house arrest since his December 11 arrest for securities fraud. The 70-year-old 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 Bloomberg.com, Madoff’s lawyer said his sons reported to prosecutors that their father had sent them jewelry and other items in violation of a court order freezing his assets. Some items were also sent to his brother. Madoff’s lawyer insisted the items were merely “heirlooms” sent innocently to his sons and brother, Bloomberg said. But U.S. Attorney Marc Litt said in court on Monday that “transfer of valuables is a “changed circumstance” that warranted the revocation of bail.”

According to a letter from Litt to the judge presiding over the case that was filed today, Madoff and his wife sent multiple packages on Dec. 24 to relatives and friends, including his sons. According to USA Today, the letter said one package contained 13 watches, one diamond necklace, an emerald ring and two sets of cufflinks - items estimated to be worth more than $1 million. Two other packages contained a diamond bracelet, a gold watch, a diamond Cartier watch, a diamond Tiffany watch, four diamond brooches, a jade necklace and other assorted jewelry.

All of those packages have been recovered, the letter said. However, prosecutors said they did not know, and have not recovered, what was in packages sent to Madoff's brother and an unidentified couple in Florida, USA today said.

"The need for detention in this case is clear," Litt wrote in the letter to the judge. "The continued release of the defendant presents a danger to the community of additional harm and further obstruction of justice.

In other Madoff news, Bloomberg News is reporting that some defrauded Madoff investors could recover a portion of their funds in then next couple of months if their accounts with him are easy to trace. Stephen Harbeck, head of Securities Investor Protection Corp. (SIPC), said that those with more-difficult-to-trace accounts might have to wait much longer.

The SIPC is a nonprofit organization funded by the securities industry to aid investors affected by failed firms that has started the process of liquidating the Madoff brokerage firm. The organization's funds cover securities and cash claims of as much as $500,000 per customer, including as much as $100,000 in cash.

According to Bloomberg, Harbeck said the Madoff case "is of a completely different order of magnitude" from anything the SIPC has seen before.

FDA Announces Recall of SimplySmart "Remove" Make-Up Remover

Wed, 07 Jan 2009 00:00:00 -0800

All lots of Celeste Industries Corporation’s SimplySmart™ “Remove” Make-Up Remover are being recalled in the United States and Canada because of bacterial contamination. The U.S. Food and Drug Administration (FDA) announced that the Celeste SimplySmart™ Remove Make-Up Remover is packaged as a single towelette and that the word “hiexpress.com” appears on the towelette’s package.

The FDA said that Celeste Industries Corporation voluntarily recalled all lots of its SimplySmart™ "Remove" Make Up Remover after a consumer complained of an odor coming from the towelette packets and testing revealed positive results for the Pseudomonas aeruginosa bacteria. The FDA explained that the organism Pseudomonas aeruginosa may cause serious eye infections; respiratory infections; dermatitis; soft tissue infections; bacteremia; and a variety of systemic infections, particularly in patients who are immunosuppressed. Also, the FDA notes that because the Celeste SimplySmart™ Remove Make-Up Remover may be used in the eye area, it is possible that the bacteria could enter the eye, resulting in serious eye infections.

The Celeste SimplySmart™ Remove Make-Up Remover is not sold in the retail market, but is provided as a guest amenity at Holiday Inn Express® hotels in the United States in Canada, the FDA said. Celeste Industries Corporation describes itself as being a provider of products to the transportation industry and produces lavatory and cleaning chemicals, hand-care systems, and amenity items to over 100 clients in over 82 countries. The SimplySmart™ “Remove” Make-Up Remover product is one of Celeste’s amenity items. Celeste Industries stopped production of the SimplySmart™ Remove Make-Up Remover on October 5, 2008 and has since identified the source of the contamination.

The FDA is advising hotel guests who may have taken the Celeste SimplySmart™ “Remove” Make-Up Remover product to not use the recalled Celeste Remover and destroy it immediately. The FDA is also advising consumers who have used the recalled make-up remover and who have concerns to contact a healthcare professional.

The FDA has also advised consumers with questions about the recall to contact Celeste Industries Corporation at 410-822-6200, ext 1349 between 8:00 a.m. and 5:00 p.m. EST; ask for the Quality Assurance department. Consumers can also email Celeste Industries at recall@celestecorp.com. The Celeste Industries Corporation Website is http://www.celestecorp.com/index.html.

Former Regulator Said TVA Could Have Prevented Coal Ash Spill

Wed, 07 Jan 2009 00:00:00 -0800

A former federal regulator claims the Tennessee Valley Authority (TVA) ignored two leaks at its Kingston Fossil Plant's fly ash retention pond that could have been a warning of the disaster to come. Retired engineer Jack Spadaro told the Associated Press that the leaks, which occurred in 2003 and 2006, were an indication of a serious stability problem with the pond's retention walls.

Those stability problems may have led to the December 22 breach that sent a billion gallons of potentially toxic coal ash into neighborhoods around the Eastern Tennessee TVA plant. The TVA has said that at least 300 acres of land had been coated by the sludge, making it 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 Associated Press, a 2008 inspection report said the TVA stopped dredging operations in a main pond after the 2003 leak, but continued using a smaller temporary pond while repairs were made. TVA resumed dredging in 2006, only to find ash seeping out of the dike just nine months later. The authority then installed a system to relieve pressure on the walls.

Glen Pugh, program director for Tennessee's division of solid waste management, the state agency charged with regulating coal ash ponds, told the Associated Press that his agency was "focused on the effect on the environment". Pugh said nothing in the TVA's inspection reports led to concerns about the retaining wall's structural integrity.

But Spadaro, who directed the National Mine Health and Safety Administration's training academy, told the Associated Press that VA's last inspection report indicated the agency was irresponsible for failing to see these previous failures as an indication of a serious stability problem. According to the Associated Press, Spadaro is all-too familiar with coal ash spills - he investigated a similar disaster in 197 that killed 125 people in West Virginia.

Spadaro told the Associated Press that after the leaks were discovered, the TVA should have drained the pond and rebuilt the dam, rather than attempt repairs.

Spadaro also said that the TVA spill shows that states are not doing enough to regulate coal ash, and the federal government should take on the job. Right now, the U.S. Environmental Protection Agency (EPA) doesn't regulate the waste because it isn't considered a hazard. But coal ash can contain heavy metals and other toxins. In fact, it is known that the waste that spilled from the TVA pond contained dangerous substances, including arsenic.

Unregulated coal ash ponds pose a danger in many states, according to report in The New York Times. There are currently around 1,300 unregulated coal ash ponds across the U.S., the Times said. Numerous studies have shown that the ash can leach toxic substances that can cause cancer, birth defects and other health problems in humans, and can decimate wildlife populations around the dumps.

According to the Times, a 2007 EPA report identified 63 sites in 26 states where the water was contaminated by heavy metals from such dumps, including three other TVA sites. Environmental advocacy groups have said that at least 17 additional sites should be added to that list.

The EPA has been studying the issue for 28 years, and regulation has largely been up to the states. Sadly, as the TVA spill illustrates, states often aren't up to the job.

Three CPSC Recalls: Viking Toaster, SRAM Bicycle Forks, Ms. Bubble Hooded Jackets

Wed, 07 Jan 2009 00:00:00 -0800

The U.S. Consumer Product Safety Commission (CPSC) has just announced three recalls over shock, crash, and strangulation hazards. Two of the recalled items were manufactured in China and one was made in Taiwan.

Ms. Bubbles Inc. of Los Angeles, California, is recalling about 55,000 Girls Blue Denim Passport hooded jackets with drawstrings due to a strangulation hazard. The Ms. Bubbles Girls Blue Denim Passport Jackets were made in China and produced with a drawstring threaded through the hood, a known strangulation hazard to children. The CPSC noted that In February 1996, it issued guidelines (pdf) to help prevent children from strangling or becoming entangled on the neck and waist drawstrings in upper garments, such as jackets or sweatshirts. The recalled Ms. Bubbles Girls Blue Denim Passport Jackets have a white terrycloth underlay lining and drawstring and were sold in children’s sizes medium (7-10), large (11-14), and x-large (15-16) and contain style number BF1400 KP on the hang tag attached to the garment.

The recalled Ms. Bubbles jackets were sold at T.J. Maxx, J.C. Penney, and Forman Mills stores nationwide from August 2007 through December 2007 and retailed for about $10. The CPSC is advising consumers to immediately remove the drawstrings from the recalled sweatshirts or to return the defective garment to either the place of purchase or to Ms. Bubbles Inc. for a refund. Ms. Bubbles can be reached toll-free at (866) 342-3802 between 8:00 a.m. and 6:00 p.m. PST, Monday through Friday.

The Viking Range Corporation of Greenwood, Mississippi is recalling about 10,000 Four-Slice Electric Toasters due to a shock hazard. The CPSC announced that wiring within the Viking Range Four-Slice Electric Toasters can loosen and come into contact with the toaster body, which poses a shock hazard. To date, Viking has received five reports from consumers who experienced a shock when they touched the outside of the Viking Four-Slice Toaster. Viking Professional Four-Slot Toasters with model numbers VT400WH, VT400BK, VT400GG, VT400SG, VT400BR, and VT400CB are involved in the recall; the toaster contains a label on its underside that states, in part: “Viking, UL Listed 73D3, Viking Range Corporation, Model VT400 Series.”

The recalled Viking toasters were made in China and sold at culinary products retailers, online dealers, and Viking’s Website from April 2005 through November 2008 and retailed for about $300. The CPSC is advising consumers to immediately stop using the recalled Viking Four-Slot toasters, unplug the defective device, and contact Viking for a free replacement. Viking can be reached toll-free at (888) 267-4460 between 8:00 a.m. and 5:00 p.m. ET Monday through Friday, or at the firm’s Website at www.vikingrange.com.

SRAM LLC of Chicago, Illinois is recalling about 175 bicycles with RockShox Bicycle Forks due to a crash hazard. The recalled SRAM bicycles use the RockShox Domain 302 and 318 bicycle forks with steel steerers, which were sold for installation on new bicycles and are being recalled because the steerer can crack, which can cause the fork to detach from the bicycle frame, causing the rider to lose control and crash. The CPSC said one incident with a minor injury has been reported and two other incidents, without injury, were reported outside of the United States. The recall affects SRAM forks manufactured between March and October 2008 with dates codes 09T8 through 42T8; the date code can be found on the back of the fork crown and on the lower leg. The RockShox Domain fork was installed on Transition Bottle Rocket bicycles and may have been installed on Rocky Mountain Flatline 1, Rocky Mountain Slayer SS350, and Rocky Mountain Slayer SS396 bicycles, the CPSC said.

The recalled products were made in Taiwan and sold at specialty bicycle retailers nationwide from March through November 2008 for between $1,600 and $3,100. The CPSC said that consumers should stop using bicycles equipped with these forks immediately and contact their bicycle retailer for a free replacement fork. SRAM can be reached toll-free at (800) 346-2928 Monday through Friday, 9:00 a.m. to 5:00 p.m. CT, or at the firm’s Website at www.sram.com

More Jardine Cribs Recalled

Wed, 07 Jan 2009 00:00:00 -0800

A recall of defective Jardine cribs first issued in June has been expanded. The Consumer Products Safety Commission (CPSC) said the recall expansion was necessary because it had received more reports of the Jardine cribs breaking and endangering children.

The original Jardine crib recall involved approximately 320,000 beds. The recall was issued because spindles on the crib can break, which creates a gap, which can then pose an entrapment and strangulation hazard to infants. At the time, there had been 42 incidents of crib slats and spindles break. Four children had become entrapped in the broken cribs, and two had been injured.

According to the CPSC, there have been 19 additional incidents of crib slats breaking. In nine of these incidents, consumers reported that their infant or toddler broke the slat while in the crib. In addition, a 22-month-old child fell through the gap between the crib slats when a slat broke. No injuries have been reported.

The Jardine crib recall expansion includes three models of Jardine wooden cribs. These models are:

Dark Pine Olympia Lifetime Crib, Model #: DA715BC, Date Code Between 2/04 - 1/07
Antique Walnut Capri Single Crib, Model #: 0108L00, Date Code Between 7/06 - 11/07
White Capri Lifetime Crib, Model #: 0308C00, Date Code Between 12/05 - 11/07

The date code and model number are printed on the label located on the inside of the bottom rail of the headboard or footboard. Jardine cribs with other date codes are not included in this recall.

These newly-recalled Jardine cribs were sold at KidsWorld, Geoffrey Stores, Toys “R” Us, and Babies “R” Us stores nationwide, and at babiesrus.com, from March 2004 through January 2009 for between $220 and $330.

Consumers should immediately stop using the recalled cribs and contact Jardine to receive a full credit toward the purchase of a new crib. The CPSC said Jardine will provide consumers with detailed instructions for purchasing cribs in retail stores and online.

For additional information, consumers may contact Jardine at (800) 646-4106 between 8 a.m. and 4:30 p.m. ET Monday through Friday, between 9 a.m. and 1 p.m. ET Saturday, or visit the firm's Web site at http://www.jardinecribrecall.com/.

Canada Issues Another Chantix Warning

Wed, 07 Jan 2009 00:00:00 -0800

Health regulators in Canada have issued another Chantix warning. Health Canada said the new alert was meant to serve as a reminder to consumers that it is still in the process of further strengthening the labeling for Chantix with respect to the risk of serious psychiatric adverse effects.

Chantix (sold as Champix in Canada) works by blocking nicotine receptors to the brain. When it was first introduced, Chantix was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy. But the drug has been linked to disturbing side effects, including suicidal thoughts and behavior.

Last February, the U.S. Food & Drug Administration (FDA) said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” Chantix maker Pfizer elevated the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with black box warning - the agency’s highest safety alert.

The Canadian Product Monograph for Chantix was first updated in December 2007 and again in May 2008 to reflect important safety information related to serious psychiatric side-effects. Yesterday, Health Canada said it was issuing its latest Chantix reminder because the New Year often prompts people to undertake anti-smoking efforts. The agency said anyone considering using Chantix should:

Be aware of any unusual thoughts, feelings or behaviors, especially those related to depression, aggression or self-harm. Patients should stop the drug immediately if there are such concerns.
Tell a doctor if they have experienced depression or other mental health problems before taking Chantix, as these symptoms may worsen while taking the drug.
Avoid driving a car or operating hazardous machinery until they are reasonably certain that Chantix does not affect them adversely.

In the U.S. Chantix continues to be the subject of numerous side effect reports. Just this past October, a report issued by the non-profit Institute for Safe Medication Practices found that in the first quarter of 2008, the FDA received more serious side effect reports for Chantix than for any other medication. According to the Institute, the Chantix side effects reported in that time frame included 50 deaths, 52 cases that may have involved various kinds of blackouts, and 15 adverse events that were linked to road traffic accidents.

OTC Cold Meds Not the Best Choice for Kids

Tue, 06 Jan 2009 00:00:00 -0800

The use of over-the-counter (OTC) cold and cough medications has been a point of concern for some time now in the United States. Early last year, Health Canada—Canada’s federal health agency—recommended parents not give over OTC cold medications to children under the age of two, citing evidence of limited effectiveness in this population, reported Reuters. Reuters also reported last month that Health Canada raised the age to six over issues of misuse and overdosing problems.

Now, Reuters is reporting that the U.S. Food and Drug Administration (FDA) is warning these drugs can adversely affect young children, specifically under the age of six, with side effects such as hives, drowsiness, difficulty breathing, and, in the worst of situations, death.

Esther Yoon, M.D., general pediatrician in the Department of Pediatrics and Communicable Diseases at the University of Michigan Health System, told Reuters that "Some 7,000 children end up in the emergency room each year because of problems associated with these medicines." Reuters added that the Centers for Disease Control and Prevention (CDC) reported that the majority—about two-thirds—of the events took place when children drank medication when not supervised and that “most” events were the result of dosing errors.

Instead of treating young children with OTC cough and cold medications, Reuters said doctors suggest that for “harsh” coughs/throat pain that OTC acetaminophen and ibuprofen be used in age-appropriate doses. For symptoms, Yoon recommends, said Reuters, that nasal saline drops and either bulb suction or the child blowing his/her nose be used for blocked noses; a teaspoon of honey or corn syrup—if the child is over one-year-old—as well as warm fluids (water, apple juice, and chicken broth were suggested) for coughs; hot shower steam to relax airways and coughing spasms; and increased humidity for nasal congestion and coughing.

For prevention, frequent hand washing, hand sanitizer use, hydration, good nutrition, and sufficient sleep, as well as teaching children to cover their mouths and noses when coughing or sneezing, are recommended, said Reuters. Yoon also told Reuters, "Other good tips include disinfecting the home, kitchen countertops, door knobs and toys" and “Children should get plenty of vitamin C and E to help fight germs, and a multivitamin is also helpful." If a child is sick over the typical four-to-five-day length for cold symptoms, Yoon recommends taking the child to his/her pediatrician, unless difficulty breathing or wheezing is present or the child is under three months of age and with a fever, in which case he/she should be seen by a doctor immediately.

In October 2007, some drug makers removed infant versions of medications off the market, including Johnson & Johnson’s Tylenol Plus Cold, Novartis AG’s Triaminic Infant & Toddler Thin Strips Decongestant, and one product sold by Wyeth under its Robitussin brand; Pediacare, Dimetapp, and Little Colds brand products were also recalled. Earlier last year the FDA issued a warning advising that OTC cold and cough medicines should not be given to children under two following a 2007 study conducted by the CDC that found that between 2004 and 2005, 1,500 children under the age of two were injured by common OTC decongestants and antihistamines; a second study by FDA safety reviewers reached similar conclusions and that research revealed that from 1969 to 2006, at least 54 children died after taking OTC decongestants, and 69 died after taking OTC antihistamines.

More Concerns Over Phthalates

Tue, 06 Jan 2009 00:00:00 -0800

A recent report by the National Research Council says current risk assessment criteria for phthalates might be lacking. The council called on the Environmental Protection Agency (EPA) to review phthalates and their health effects, Science Daily reported, announcing that there is sufficient data to warrant an agency assessment on cumulative exposure, said Reuters.

The report found that the government risk assessment methods used might not fully show the effects of the toxin, said ConsumerReports.org. In response to the EPA request, the committee found that the agency could minimize risks if combined exposure is not considered since it seems, when combined with other compounds, phthalates can be more serious, noted ConsumerReports.org.

Some phthalates are among the chemicals banned in the recently passed Consumer Product Safety Commission Improvement Act, which comes into effect next month. The Act bans three phthalates in children’s toys and products in all but the smallest of amounts and, pending additional research, bans three others. The six phthalates, say Reuters, have been banned for almost ten years in European toys and, according to Science Daily, the European Union (EU) banned some phthalates from cosmetics and has bans in place similar to the pending U.S. ban. Phthalates have been in use for decades and are linked to hormonal disturbances and other adverse effects and are often found in soft plastic toys and children’s products.

Science Daily noted that phthalates are used in other products including medical devices and building materials and Reuters reported that phthalates are also used in personal-care products, food packaging, pharmaceuticals, and cleaning materials. "Consumers can be exposed to many different phthalate compounds, so we hope this new panel will follow the report's recommendations and assess the cumulative effects of these compounds‚" ConsumerReports.org quoted Carolyn Cairns, its Program Leader for Product Safety.

Meanwhile, A recently published study of 47 medications and 8,000 participants, completed by researchers from Harvard and Boston Universities and the Centers for Disease Control and Prevention (CDC) found that metabolite levels—metabolites of several common phthalates—were considerably higher in participants taking certain drugs such as mesalamine, used to treat colitis; didanosine, an HIV medication; omeprazole, an ulcer treatment; and theophylline, an asthma and lung disease medication, said ConsumerReports; it seems phthalates can be found in some medication coatings. Worse, the team concluded that some people’s exposure levels to the toxin might exceed EPA safety thresholds, reported Consumer Reports.

Science Daily noted that the committee concluded that exposure to various phthalates in lab animals produced outcomes including effects on the development of the male reproductive system such as infertility, undescended testes and testicular development; penis and other reproductive tract malformations, such as hypospadias; and reduced testosterone levels. Some phthalates, reports ConsumerReports.org, have been associated with liver cancer and problems with the developing fetus and are known to interfere with androgens. Because different types of phthalates can cause hormonal interruptions “in ways that are different, yet lead to the same health outcome,” says Consumer Reports, the panel urges assessments that group chemicals by their outcomes, especially for hormone-mimicking issues. Science Daily noted that currently, the EPA looks at chemicals that are similar in structure, not similar in health effects.

Oregon Imposes New ATV Rules

Tue, 06 Jan 2009 00:00:00 -0800

Effective January 1, new all-terrain vehicle (ATV) rules are in place in the State of Oregon. Under Oregon's new rules, all people under the age of 16 who operate an ATV on public land must have adult supervision. According to the Mail Tribune, the adult—and the youth—must also have successfully completed a state-approved safety-training course and the youth is required to meet rider-fit guidelines for the vehicle.

The paper also provided the following information on the minimum-physical-size requirements for Class I—Quad Rider—Operators who are under 16 years of age regarding brake and grip reach, leg length, handle bars, and disabled riders:

Brake Reach: Involves hand location and finger position in relation to the brake lever and clutch.
Leg Length: Involves leg angle when sitting on the ATV.
Grip Reach: Involves arm and forearm angle when sitting on the ATV.
Handle Bars: Involves the rider’s ability to turn the handle bars from lock to lock while maintaining both a grip on the bars and throttle and brake control.
Disabled Riders: Involves the rider’s ability to use prosthetics or modified/adaptive equipment assuming appropriate rider fit is met.

John Lane, the ATV safety education coordinator for the Oregon Department of Parks and Recreation said the rules came about following an increase in ATV injuries to younger riders, according to the Mail Tribune, which noted that the Oregon Trauma Registry recorded over 1,200 such injuries in a recent five-year period, rising nearly 80 percent and injuring—in 20 percent of the cases—children under the age of 15.

Based on 2007 legislation a minimum age requirement will be phased in and will increase annually until all riders will be required to carry an ATV Safety Education Card while riding on state land, said the Mail Tribune, which added that the requirement will be in full effect in 2014. Safety training is exempt for ATV and off-road motorcycles when used for farming, agriculture, forestry, nursery, Christmas tree growing operations, and when riding on private land.

Late last year, TradingMarkets.com reported on ATV standards set forth in the Consumer Product Safety Improvement Act of 2008 (CPSIA). According to the Consumer Product Safety Commission (CPSC), “new ATVs must comply with the standard and must also have an ‘ATV Action Plan’” that contains “safety requirements on issues such as training” and indicates specific ATV equipment and configuration requirements said TradingMarkets.com, that include: “Owner's/operator's manuals, labels and hang tags, maximum speed capability, speed capability of youth ATVs, service and parking brakes, pitch stability, electromagnetic compatibility, and sound level limits.” Occupational Health and Safety (OHS) explained that ATV manufacturers and distributors’ written action plans must list not only those actions being implemented to “promote ATV safety,” the plans must include details on “rider training, age recommendations, and monitoring of sales.” OHS noted that each subject in the plan must be certified and bear a label of certification.

Drug Company Freebies Target of Voluntary Guidelines

Tue, 06 Jan 2009 00:00:00 -0800

Effective the first of this year, some drug manufacturers have stopped producing and distributing all those free marketing giveaways to doctors for which they are famous, and for which they have long been criticized. The drug company logo-emblazoned giveaways—pens, key chains, ceramic mugs, and other such knickknacks—have been making headlines recently because they are just another example of how Big Pharma and medicine mix.

DiscoverMagazine.com reports that some critics say the industry group Pharmaceutical Research and Manufacturers of America’s (PhRMA) voluntary guidelines—Code on Interactions with Healthcare Professionals—do not address the overarching issue of doctor-industry conflict of interest, what with doctors accepting payments, trips, event tickets, and funding—to name a few—from the drug industry. According to TheLasVegasGun.com, the knickknacks alone cost Big Pharma billions each year.

KaiserNetwork.org, which says PhRMA will create a company directory of firms in compliance with the guidelines, notes that the ban includes office supplies, clothing products, and other such gifts containing drug maker logos and product names targeted to doctors and facilities as well as payments for those big meals doctors are famous for receiving; grant money meant for continuing medical education must now be handled by staff not connected to sales and marketing. But, the guidelines do not cover all conflict-of-interest events. There is no maximum limit on how much money doctors can receive from industry for speaking engagements, although consulting fees—which also contain no caps—must be recorded, reported Kaiser.

The Boston Herald notes that the guidelines do not permit guests, even paying guests, from attending medical conferences and sales reps and other pharmaceutical employees are not allowed to give away items bearing logos. Also, when a drug maker foots the bill for a meal, it must be “modest” said the Boston Herald. But, industry-produced literature, charts, graphs, and other medical-related items are still permitted in locations frequented by patients in doctor offices, notes DelawareOnline.com.

In 2004, the last year for which such data is available, big pharma spend over $57 billion on marketing—typically for physician outreach, said SignOnSanDiego.com—which noted that based on a report in the journal PLoS Medicine, that money was almost twice as much as what was spent on new treatment research and development.

As we've reported previously, the financial ties between doctors, medical researchers and the drug industry go much further than just trinkets and meals. In fact, some highly regarded doctors and researchers have faced a great deal of criticism because of their financial arrangements with pharmaceutical companies.

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

Also, Fierce Healthcare noted that Emory University stripped the chairmanship from one of its more prominent psychiatric researchers—Charles Nemeroff—when an investigation revealed he had not reported significant amounts of industry-sourced income.

Finally, David Sinclair, a professor at Harvard Medical School who sat on the scientific advisory board of supplement maker Shaklee Corporation, helped promote a product claiming to possess life-extending properties, has stepped down, but remains as co-chief adviser to Sirtris Pharmaceuticals, a Glaxo division. Sinclair received over $8 million when Glaxo acquired Sirtris; the company pays him $297,000 annually as a consultant, said the Wall Street Journal. 

Melamine-Laced Topaz Wafer Rolls Finally Recalled

Tue, 06 Jan 2009 00:00:00 -0800

Melamine-tainted Topaz brand Wafer Rolls are finally being recalled nationwide by National Brands Inc. of Spring Valley, NY. According to OregonLive.com, the U.S. Food and Drug Administration (FDA) announced last month that Topaz brand Wafer Rolls had tested positive for melamine, but the FDA had no authority to remove products from shelves. According to OregonLive.com, the agency had been working with National Brands to get the recall implemented.

The recall involves 4.76oz (135gm) and 12.3oz (350gm) cans of Topaz brand Wafer Rolls. The contaminated Topaz Wafer Rolls were distributed nationwide through retail stores and are sold in four flavors: Vanilla, chocolate, hazelnut chocolate, and mocha-cappuccino and include the following:

Topaz Wafer Rolls with Chocolate Flavored Cream Filling: Lot numbers L8085A, L8219A, and L8245A.
Topaz Wafer Rolls with Hazelnut Chocolate Flavored Cream Filling: Lot numbers L8085D, L8219D, and L8245D.
Topaz Wafer Rolls with Vanilla Flavored Cream Filling: Lot numbers L8085B, L8219B, and L8245B.
Topaz Wafer Rolls with Mocha Cappuccino Flavored Cream Filling: Lot numbers L8085C, L8219C, and L8245C.

Consumers are advised by the FDA to stop using and not consume the recalled Topaz Wafer Rolls and to return the recalled product to the place of purchase for a full refund. Consumers with questions may contact the company at 1-866-238-5201, Monday to Friday 9:00 to 5:00, Eastern Standard Time.

Melamine, a toxic industrial chemical used in the manufacture of fertilizer, fire retardants, and plastics, 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 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. Since, the government there has admitted that not tens of thousands, but hundreds of thousands fell ill as a result of melamine contamination.

In sufficient quantities, ingesting melamine can cause kidney problems, including kidney stones and kidney failure, and in the case of at least six children, death. Melamine has been found in dozens of products exported globally from China including milk teas and coffees, cocoas, yogurts, candies, cookies, biscuits, cheeses, eggs, and crackers, prompting international recalls. It is also believed eggs became contaminated following feed contamination, which has since been linked to certain livestock, including chickens and pigs, and now, experts are looking at possible contamination in seafood grown in China.

Deadly New York Crane Collapse Results in Manslaughter, Other Charges for Contractor

Tue, 06 Jan 2009 00:00:00 -0800

A contractor from Long Island has been charged with second-degree manslaughter, criminally negligent homicide, reckless endangerment and assault in connection with a deadly New York City crane collapse that killed seven people last year. According to a report on Newsday.com, Manhattan District Attorney Robert Morgenthau said William Rapetti's "reckless and negligent rigging practices" led to the fatal accident last March at a construction site in Midtown.

The crane collapse occurred on the east side of midtown Manhattan the afternoon of March 18. The crane was being used in the construction of a 43-story luxury apartment building. The crane broke into pieces as it crashed down onto 51st street, not far from the United Nations Building. Several buildings were damaged in the New York crane collapse, and residents in about 300 apartments in 17 buildings were evacuated. The accident killed six workers from the construction site, as well as a Florida woman visiting the city who was staying with a friend in the destroyed townhouse.

Rapetti, the owner of Rapetti Rigging Services in Massapequa Park, was indicted, arraigned and released on $75,000 bail yesterday, Newsday said. He pled not guilty to the charges.

According to Newsday, Morganthau charged that Rapetti failed to properly stabilize the crane to a condo tower under construction. The District Attorney said the accident was the result of Rapetti's decision to use four protective slings - not eight as should have been done - to lift a six-ton piece of steel up the crane. One of the slings used was defective and snapped while raising the crane. Morganthau said the accident could have "easily been avoided" had the proper number of slings been used.

Rapetti is not the only person to face criminal charges as a result of the March crane collapse. A few days after the accident, Buildings Department inspector Edward Marquette was arrested on charges of falsifying business records and offering a false instrument for filing. Marquette was an inspector in the building department’s division of cranes and derricks. A complaint about the doomed crane was logged March 4 to a city hot line, officials said, and Marquette said he inspected it. It was later determined he had not.

According to Newsday, in September, the Occupational Safety and Health Administration fined Rapetti's company $220,000 and issued three willful violations - the most severe - for failing to inspect the slings and failing to follow proper procedure when raising or lowering a crane.

Fuel Tank Ruptured After Denver Plane Crash

Tue, 06 Jan 2009 00:00:00 -0800

Federal transportation officials investigating last month's Denver plane crash say a ruptured fuel tank was behind a spectacular fire that occurred after the Continental airlines flight careened off of the runway and Denver International Airport. According to a National Transportation Safety Board (NTSB), after the fuel tank ruptured, fuel spilled onto an engine where it ignited once the jet stopped.

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. The aircraft had traveled about one third of the length of the runway when it veered to the left and skidded into a ravine. At least 37 people were hurt in the crash.

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.

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.

At a briefing yesterday, Bill English, the NTSB's lead investigator on the crash, would not comment on any possible theories for the cause of the crash. However, he did say there was no indication of an engine failure at this point in the probe.

English said the NTSB is continuing its fact gathering, but said its on-scene investigation is over. A final report on the crash will likely take a year, but several interim "factual reports" without findings or conclusions could be released in six to nine months, English said.

Medtronic Infuse Bone Graft to be Named in Another Lawsuit

Tue, 06 Jan 2009 00:00:00 -0800

Medtronic could be facing more trouble over its Infuse Bone Graft product. According to a report on the website "Finance and Commerce", a Texas woman is preparing to file a lawsuit that blames off-label use of Infuse for injuries she suffered after cervical spine surgery.

Infuse Bone Graft contains recombinant human Bone Morphogenetic Protein (rhBMP-2), a protein released naturally by the body. It is approved to treat a spinal condition called Degenerative Disc Disease, as well as open fractures of the tibia. It is also approved for use in two dental bone grafting procedures: sinus augmentation and localized alveolar ridge augmentation.

In July, the Food & Drug Administration (FDA) warned that the use of Infuse Bone Graft and similar devices had caused serious problems when they were used off-label in cervical spine (neck) surgeries. Patients reported difficulty swallowing, breathing and speaking. Several required emergency treatment, including tracheotomies and the insertion of feeding tubes, as well as second surgeries.

In September, the Wall Street Journal reported that at least three-quarters of the roughly 200 “adverse events” reported to the FDA involve off-label uses of Infuse Bone Graft. The Journal said that most of these cases involved unwanted bone growths near nerves or in areas outside targeted fusion sites.

Doctors are free to use approved medical devices in anyway they see fit. However, manufacturers are forbidden from promoting any use that has not received FDA approval - known as off-label use.

According to "Finance and Commerce", a draft of a lawsuit being prepared on behalf of Mary Selke claims that use of Infuse during her cervical spine surgery caused bone to form in her neck, impeding her breathing and swallowing to the extent that she required emergency surgery. "Finance and Commerce" also reported that Selke's lawyer said her physician will "provide testimony stating ways in which Medtronic has promoted the off-label use of the product among physicians".

As we've previously reported, Medtronic already faces a lawsuit filed by the family of a woman who received Infuse during neck graft surgery, and later died. That lawsuit claims that a Medtronic sales representative was in the operating room before and during the patient's surgery, and encouraged her doctor to use Infuse in the off-label procedure.

Off-label use of Infuse Bone Graft was also the subject of a subpoena filed by the U.S. Department of Justice in November. Medtronic insists that it does not promote off-label use of Infuse, and claims that if doctors were using the bone graft product in off-label procedures, it was because they had determined it was the best therapy for their patients.

According to "Finance and Commerce", the Minneapolis Firefighters’ Relief Association has also filed a class-action shareholder lawsuit against Medtronic on Dec. 12, alleging that the company did not reveal that most of its revenue came from off-label use of Infuse, did not reveal that off-label use was causing major complications and did not disclose that it adopted an unlawful marketing campaign to promote its use.

Bernard Madoff Faces Possible Bail Revocation

Tue, 06 Jan 2009 00:00:00 -0800

The Bernard Madoff investment fraud scandal took an interesting turn yesterday, as federal prosecutors sought to have Madoff's $10 million bail revoked. Prosecutors sought the revocation after they learned that Madoff had mailed "some very valuable jewelry" to his sons and brother after his assets were frozen in a civil lawsuit.

Madoff has been under house arrest since his December 11 arrest for securities fraud. The 70-year-old 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 Bloomberg.com, Madoff's lawyer said his sons reported to prosecutors that their father had sent them jewelry and other items in violation of a court order freezing his assets. Some items were also sent to his brother. Madoff's lawyer insisted the items were merely "heirlooms" sent innocently to his sons and brother, Bloomberg said.

But prosecutors clearly disagree. According to Bloomberg.com, U.S. Attorney Marc Litt said in court yesterday that "transfer of valuables is a “changed circumstance” that warranted the revocation of bail." He put the value of the items mailed by Madoff at around $1 million.

If Madoff's bail is revoked, he would have to leave his posh Manhattan apartment for jail.

Meanwhile, the House Financial Services Committee held a hearing yesterday to address the Securities and Exchange Commission's (SEC) apparent failure to detect Madoff's decades-spanning fraud. The Wall Street Journal reported yesterday that the SEC failed to spot the fraud, despite receiving numerous tips, and investigating Madoff eight times in the last 16 years. Shortly after Madoff's arrest, the SEC launched its own internal investigation into how his alleged Ponzi scheme was able to continue unchecked for so long.

According to CNN.com, H. David Kotz, the SEC's inspector general, told Congress Monday that the investigation was ongoing. He added that his office planned to look at, among other things, complaints about Madoff's activity and any other conflicts of interest between SEC officials, its staff and members of Madoff's family.

In addition to hearing from SEC officials, the Committee took testimony from one of Madoff's alleged victims. What he had to say was often poignant. Allan Goldstein, a 76-year-old former textile salesman from upstate New York, told lawmaker his entire life savings, which was worth as much as $4.2 million just months ago, has vanished. According to CNN, Goldstein said he feared he and his wife might now face foreclosure on his home because of their resulting financial woes.

"We are not trust funds, hedge funds or banks," said Goldstein. "We are ordinary people who are victims of an incomprehensible crime and who have had their lives turned upside down."

TVA Fly Ash Spill Subject of Senate Hearing on Thursday

Tue, 06 Jan 2009 00:00:00 -0800

A Senate committee will look into last month's Tennessee Valley Authority (TVA) fly ash spill at a hearing scheduled for Thursday. According to a report on Bloomberg.com, the hearing before the Senate Committee on Environment and Public Works will focus on whether more federal oversight of coal waste storage sites is needed.

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 at least 300 acres of land had been coated by the sludge, making it 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 Bloomberg.com, TVA CEO Tom Kilgore will be among the witnesses who testify at Thursday's Senate hearing. Since the spill some have voiced concerns that the TVA was able to avoid closer oversight prior to the catastrophe because it got deferential treatment from both federal and state regulators, Bloomberg said.

According to the Bloomberg report, The TVA provides power to industry and about 9 million people in the river valley that runs from southern Virginia to northern Mississippi. The federally owned company receives no government funds and isn’t publicly traded, although it sells bonds. Tennessee Governor Phil Bredesen, a Democrat, said last week that the TVA may have been given too much leeway because it is federally owned, Bloomberg reported.

Since the spill, calls for change in the way coal wastes are regulated have come from several quarters. According to Businessweek.com, Tennessee Senator Bob Corker, a Republican, said the spill should be a "wake-up call" for greater environmental and regulatory oversight.

Businessweek.com also said that Bredesen has promised to review state regulatory practices and the federal Environmental Protection Agency has suggested taking on greater oversight of coal waste piles. And according to Bloomberg.com, Representative Nick Rahall, the West Virginia Democrat who heads the House Natural Resources Committee, may offer legislation mandating that coal-ash storage sites meet federal standards similar to those already in place for storing waste from coal-mining.

Gardasil Approval for Boys Sought

Tue, 06 Jan 2009 00:00:00 -0800

Gardasil maker Merck & Co. is officially seeking approval for use of the cervical cancer vaccine in boys. The company is also asking the U.S. Food & Drug Administration to expand the approval of Gardasil in women ages 27 to 45 years. The vaccine is currently only approved for women and young girls ages 9 to 26.

Gardasil was approved by the FDA in June 2006. At the time of its approval, Merck said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of the Human Papillomavirus (HPV) that cause cervical cancer. Shortly after its approval, the U.S. Centers for Disease Control (CDC) issued a recommendation that all young girls between the ages of 11 and 12 receive the Gardasil vaccine.

But not everyone has been so enthusiastic about Gardasil, mainly over safety concerns. There have been 9,749 adverse reactions following Gardasil and 21 reported deaths since 2006. Those side effects, which were reported to the FDA and CDC via the Vaccine Adverse Event Reporting System (VAERS) included 10 miscarriages, 78 severe outbreaks of genital warts and six cases of Guillain-Barré syndrome, an autoimmune disorder that can result in paralysis.

Other questions have been raised about the cost effectiveness of HPV vaccines like Gardasil. Those concerns were explored by an article in the New England Journal of Medicine this past August. The article detailed a analysis done by Harvard researchers on the cost effectiveness of Gardasil, and another HPV vaccine called Cevarix. Cevarix, made by GlaxoSmithKline, has not been approved by the FDA yet, but is widely used in Europe.

To measure the health benefit of vaccination, the researchers looked at the cost savings from preventing cervical cancer with the vaccine and Pap tests compared with prevention via the tests alone. A treatment is typically considered cost effective if it is less than $50,000 or $100,000 for one additional year of life

The Harvard analysis predicted that it would $43,600 to extend life expectancy by one year when girls are vaccinated at 12. When girls up to age 18 are included in the analysis, that ratio rises to $97,300 and to $153,000 through age 26, the study found. That’s because vaccination is less effective after a woman is sexually active, and may have already been exposed to HPV.

In Western countries like the U.S., regular screening via Pap tests has already greatly reduced incidences of cervical cancer and deaths. But even after vaccination, regular Pap tests are necessary because the shots don’t protect against all HPV strains known to cause the cancer.

Despite questions surrounding its safety and cost-effectiveness, Merck still wants the uses of Gardasil expanded. According to The Wall Street Journal, Gardasil is a key product for Merck, which estimates sales this year of as much as $1.6 billion. But sales have slowed, down 4% in the third quarter compared to a year earlier. Merck's crusade for expanded approval may be part of a strategy to lift these sagging sales.

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.