The US Department of Agriculture (USDA) recently announced that the Hallmark/Westland Meat Packing Company was recalling 143 million pounds—65 million kilos—of meat, following a videotape of plant workers forcing unfit cattle into slaughter.  Most of the meat has likely been consumed; at least 37 million pounds were used for school lunches and federal nutrition programs, according to the USDA.  Now people are wondering if anyone fell ill from the recent recall and if E. coli was involved.

The videotape was obtained by the Humane Society and showed animals that could not walk on their own being prodded and, in some cases, fork-lifted onto the killing floor. When animals fall ill, packers are required to alert USDA veterinarians so they can decide if the animal can be slaughtered for food.  While consumers were horrified at how the cattle were treated, the cruelty they endured was not what got the attention of the government.  The USDA forbids cows that cannot move on their own from being slaughtered because their illness may be an indication of a condition that renders their meat unfit for consumption.  The most famous condition of concern is Bovine spongiform encephalopathy, or mad-cow disease.  While cattle are afflicted with BSE, humans who eat infected meat are at a risk of contracting Variant Creutzfeldt-Jakob disease [vCJD]. (more…)

LASIK surgery - a procedure that can sometimes lead to life-altering complications –  has caught the eye of federal regulators.  When patients undergo vision-correcting laser eye surgery—such as LASIK—they sign a release form with an extensive list of risks. However, researchers and former patients say a potential complication is not mentioned:  depression leading to suicide. In response to patient complaints, the US Food and Drug Administration (FDA) plans to organize a large, national study to examine the relationship between LASIK complications and quality of life issues, including psychological problems such as depression.

Malvina Eydelman, an ophthalmologist with the FDA’s Center for Devices and Radiological Health, says the limited clinical data “failed to suggest significant problems following LASIK surgery.”  Confirming that the FDA wants a broad and systematic review, she said, “We also noted that quality of life issues related to LASIK had not been evaluated consistently and there were few reports of well-designed studies.”  While frustration and sadness can result from any unsuccessful surgery, when left with constant eye pain or permanently impaired vision, the response can be severe.  For instance, Colin Dorrian, 28, a patent lawyer and aspiring medical student from Philadelphia committed suicide last summer, six years after LASIK surgery left him with visual distortions.  The surgery was conducted at a LASIK center in Canada that has since closed.  “If I cannot get my eyes fixed, I’m going to kill myself,” he wrote in a note police found, adding, “I have other problems like most people do.  But this is something else.  As soon as my eyes went bad, I fell into a deeper depression than I had ever experienced, and I never really came out of it.” (more…)

Controversial Lipitor TV ads have been removed from the airways.  Pfizer announced Monday it would cancel a long-running ad campaign using artificial heart pioneer Robert Jarvik as a spokesman for its cholesterol drug Lipitor.  Pfizer spent over $258 million in advertising since January 2006, mostly on the Jarvik campaign, hoping to protect Lipitor from competition by cheaper generics.

The Jarvik ad campaign has come under scrutiny from a Congressional committee examining consumer drug advertising and questions if the ads misrepresented Jarvik and his credentials.  While Jarvik does have a medical degree he is neither a cardiologist, nor is he licensed to practice medicine.  In one ad Jarvik is presented as an accomplished rower; that ad used a body double for Jarvik, who does not row.  “The way in which we presented Dr. Jarvik in these ads has, unfortunately, led to misimpressions and distractions from our primary goal of encouraging patient and physician dialogue on the leading cause of death in the world—cardiovascular disease,” Pfizer’s president of worldwide pharmaceutical operations, Ian Read, said. “We regret this.  Going forward, we commit to ensuring there is greater clarity in our advertising regarding the presentation of spokespeople.”  A company spokeswoman, Vanessa Aristide, said Pfizer was working with its ad agency, the Kaplan Thaler Group, on a new campaign. (more…)

Denture cleaners like Polident and Fixodent have caused serious and sometimes fatal reactions in some users.  US regulators announced Monday that one person died and at least 72 others were sickened as a result of allergic reactions to denture cleaners.  In some cases, the reactions were a result of product misuse.  The Food and Drug Administration (FDA) blamed a bleach called persulfate, an allergen used in most denture cleansers, according to notices posted on the FDA’s Website. Persulfates are used in these products as part of the cleaning and bleaching process.

The FDA is urging doctors and patients to be aware of the symptoms of an allergic reaction and to only use the cleansers as directed.  The one person who died and some of those who were sickened misused the cleaners, the FDA said. “Some patients have gargled or swallowed it, resulting in abdominal pain, vomiting, seizure, hypotension and difficulty breathing,” it said.  Meanwhile, some who reported allergic reactions used the cleaners properly, the FDA said.  Allergic reactions happened quickly in some and after years of use in others, it said.  The FDA didn’t say how long it had been collecting reports of denture cleanser side effects, but recommended all denture cleanser makers add a warning about the risk of allergic reactions and place better patient instructions on package labeling. (more…)

Drug advertising will be getting more scrutiny at the Food & Drug Administration (FDA) thanks to a new funding initiative. The FDA received $6.1 million in this year’s budget to monitor consumer drug ads for fairness and accuracy. That’s up from $2.2 million the previous year and $1 million the year before.

Recently, a string of drug safety scandals have highlighted what some have said are weaknesses in the way the FDA monitors the pharmaceutical industry. One area that has received a lot of criticism has been direct-to-consumer drug ads. In January, after the ENHANCE study was released that showed the anti-cholesterol drug Vytorin worked no better than cheaper statins, Congress began a probe of the way Vytorin was marketed by Merck and Schering-Plough. One issue that concerned lawmakers was why the drug makers - after having completed ENHANCE in April 2006 - kept running their catchy Vytorin ads on TV, touting it as being more effective than a statin alone. (more…)

The situation that sparked the Hallmark/Westland meat recall earlier this month might not be an isolated incident.  Other meat processors might be illegally slaughtering so-called downer calls, but the US Department of Agriculture (USDA) says it has no way of knowing if meat processors follow downer cow rules.  That frank admission from the head of USDA is just more evidence that the agency is in over its head, and is not doing enough to keep the food supply safe.

The USDA announced earlier this month that the Hallmark/Westland Meat Packing Company was recalling 143 million pounds of meat, making it the largest meat recall in US history.  Most of the meat is beef and the recall comes after plant workers were caught on videotape forcing unfit cattle into slaughter.  The head of the USDA said officials are reviewing why the plant processed the downer cows, and also said that  it was too early to determine if such incidents were isolated to Hallmark/Westland.  “We are reviewing our procedures, how we work with the plant, how our inspectors work, our staffing needs,” Agriculture Secretary Ed Schafer said.  “And until we find out, we can’t assess other plants, and we can’t say… this is an isolated incident or an ongoing practice.”  Most of the meat has likely been consumed, but at least 37 million pounds were used for school lunches and federal nutrition programs, according to the USDA. (more…)

Another magnetic toy set is being recalled over concerns that magnets can come loose, posin a risk of intestinal injuries if a child swallows one.  The U.S. Consumer Product Safety Commission (CPSC), in cooperation with Family Dollar of Charlotte, North Carolina, announced a voluntary recall of 250,000 FUN ‘N SAFE Magnetic Dart Boards.  The FUN ‘N SAFE Magnetic Dart Boards were made in China and sold exclusively at Family Dollar stores nationwide for the seven-year period from January 2001 through January 2008.  The toys retailed for about $5.

The FUN ‘N SAFE Magnetic Dart Board is about 15 inches wide with a black, white, green, and red bull’s eye checkered design and was sold with six four-inch long magnetic darts. The darts magnetically adhere to the dartboard when thrown. “Made in China” is embossed on the back of the board. (more…)

Avastin has been approved by the Food & Drug Administration (FDA) to treat advanced breast cancer, despite a recommendation from the agency’s own advisory panel that it not expand the approved uses of Avastin, and concerns over the drug’s safety.  In the end, the FDA decided to approve Avastin on the basis that it has been shown to slow tumor growth, even though it has not been shown to increase survival time or improve quality of life in patients with advanced breast cancer.

Avastin was approved by the FDA in 2004 to treat colon cancer, and in 2006, the agency approved it as a treatment for non-small cell lung cancer.   Avastin was the first approved therapy designed to inhibit angiogenesis, the process by which new blood vessels develop and carry vital nutrients to a tumor. Avastin has been a blockbuster for Genentech, and its parent company Roche AG.  For the first nine months of 2007, US sales of Avastin topped $1 billion, accounting for 27% of Genentech’s overall product sales. (more…)

Two more recalls were announced last week by the Consumer Product Safety Commission (CPSC) that emphasize some ongoing safety concerns over two popular household products:  Ladders and oscillating heaters.  These recalls serve as a reminder that consumers should conduct frequent safety inspection of these items, regardless of their recall status.

The CPSC recalled 152,000 “Aloha Breeze’” portable electric heaters for overheating problems:  Plastic parts can melt and the heaters are a fire hazard.  In all, there have been 29 reports of heaters melting, smoking, or catching fire, including 18 reports of property damage and one report of burns to a consumer’s hands and feet.  The “Aloha Breeze” heater was made in China and sold at Wal-Mart and other retail chain stores nationwide from August 2006 through November 2007 and retailed for between $35 and $45.  The “Aloha Breeze” heater is an oscillating heater—that is, it contains a mechanism that enables it to move from side to side, spreading heat in multiple locations.  While the oscillation technology better heats a room, the current safety standard for oscillating heaters may not be strong enough to protect consumers from some of their associated dangers; efforts are underway to revise and strengthen that standard.  But, for now, it is suggested that fans be used in oscillating mode only when necessary and always when attended by an appropriate adult.  Frequently inspect the cord for fraying or weakness, especially where the cord enters the unit and never use a heater whose cord shows weakness or fraying.  The CPSC advises consumers to immediately stop using the recalled heaters and contact Aloha Housewares at 1-800-295-4448 to receive a free replacement product. (more…)

The US Department of Agriculture (USDA) is so shorthanded that the safety of the US food supply is at risk.  Every single animal sent to slaughter must pass inspection; however, USDA inspectors are so short-staffed that they must look down at hundreds of animals at once from catwalks hoping to catch signs such as droopy ears, stumbling gait, and facial paralysis.  There is such a shortage of USDA inspectors that slaughterhouse workers often know when surprise visits occur and ensure they behave accordingly.  All this according to former and current USDA inspectors following the biggest beef recall in history—143 million pounds from California meatpacker Hallmark/Westland.  Hallmark/Westland is accused of sending lame “downer” cows to slaughter and was caught doing so in a US Humane Society videotaped investigation.

USDA inspectors are concerned staff shortages are allowing sick cows into the nation’s food supply, endangering the public.  According to USDA figures, inspector ranks nationwide had vacancy rates of 10 percent or more in 2006-07.  “They’re not covering all their bases.  There’s a possibility that something could go through because you don’t have the manpower to check everything,” said Lester Friedlander, former USDA veterinary inspector.  Amanda Eamich, a spokeswoman for the USDA’s Food Safety and Inspection Service (FSIS), acknowledged the department has been struggling to fill vacancies but denied risk to the food supply.  “Every single animal must past ante-mortem inspection before it’s presented for slaughter, so only healthy animals are going to pass,” she said. “We do have continuous inspection at slaughter facilities.”  Current and former inspectors and other industry critics argue that staff shortages are resulting in the mistreatment of animals going to slaughter which may have contributed to the recent recall. (more…)