Genentech—the maker of Avastin—appears to have resolved a dispute with ophthalmologists that will allow Avastin to continue to be used to treat eye diseases, both sides announced on Thursday.  Genentech angered many eye doctors in October when it announced a change in the distribution of Avastin that would have made it difficult for the doctors to use the drug. The doctors accused the company of trying to force them to use a much more expensive Genentech drug, Lucentis, instead.  Lucentis is approved to treat macular degeneration; a disorder that affects the macula—the central part of the retina—causing decreased vision and possible loss of central vision.  Macula degeneration is a leading cause of blindness among the elderly.  But each injection costs about $2,000 and injections are needed as often as once a month.

Many ophthalmologists are instead resorting to off-label use of Avastin, which is approved only to treat cancer but works in the same way as Lucentis.  Doctors are free to prescribe Food and Drug Administration (FDA)-approved medications as they see fit, including off-label.  It is off-label marketing of FDA-approved medication—marketing for uses not approved by the FDA—which is illegal.  The eye doctors have been relying on compounding pharmacies to divide a vial of Avastin meant for cancer treatment into tiny portions for use in the eye under sterile conditions.  In these small doses, Avastin costs $20 to $100 per injection.  But Genentech said in October that it would no longer sell Avastin to compounding pharmacies, which specialize in the mixing of medications.

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Worries about hormone-mimicking BPA used in sports bottles led a major Canadian retailer to remove Nalgene and other polycarbonate plastic containers from store shelves in early December.  BPA—or bisphenol A—mimics the effects of estrogen in cells and some researchers and environmentalists revealed it can be toxic and cause several types of cancer (breast and prostate) as well as developmental, neural, behavioral, and reproductive harm (miscarriages and other reproductive failures), and obesity and hyperactivity in animals.  Fred vom Saal, professor of biology at the University of Missouri and one of the study’s chief authors said the panel reviewed 700 published articles on BPA, practically all published in the last 10 years, yet US health and environmental regulators “are pretending they’re still in the dark.”

Industry maintains BPA is not dangerous, citing studies from government agencies such as the Food and Drug Administration (FDA) that containers manufactured from polycarbonate do not pose health risks to humans.  Meanwhile, Vancouver-based Mountain Equipment Co-Op (MEC) became the first major Canadian retailer to stop selling BPA-containing products and is waiting for Canadian health regulators to finish a preliminary review.  The consumer cooperative is Canada’s largest with 2.7 million members.  In response, the FDA reiterated that “BPA has been used in consumer products for over 50 years.  In that time, there has been no evidence that BPA is harmful to humans, either as the result of dietary intake or industrial worker exposures.”  Patagonia Inc., another outdoor-gear retailer based in Ventura, California, pulled polycarbonate water bottles from its 40 stores worldwide in December 2005.  A month later, organic foods chain Whole Foods Markets stopped selling polycarbonate baby bottles and child drinking cups.  Norway and the European Union are also reviewing BPA; Japanese manufacturers stopped making products using polycarbonate plastic years ago.

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November’s Jeno’s and Totino’s frozen meat pizza recall has taken a toll on General Mills’ bottom line.   According to the company, its Pillsbury USA  division that made the E. coli tainted Jeno’s and Totino’s pizzas was hit particularly hard, as net sales for the division fell two percent.  According to General Mills, the Jeno’s and Totino’s pizza recall knocked $20 million off its second quarter operating profit. Overall, the E. coli pizza recall helped to increase the cost of sales to $2.3 billion, a 7.8 per cent increase from the same period in 2006.

On November 1st, General Mills recalled Totino’s and Jeno’s frozen pizza due to E coli O157:H7 contamination. The Totino’s and Jeno’s pizza recall involved some 414,000 cases of frozen pizzas (nearly 5 million individual pizza pies) already shipped to stores. At least 21 people contracted the same E. coli 0157:H7 strain linked to the General Mills Jeno’s and Totino’s frozen meat pizzas, and nine of those victims have reported eating the E. coli-tainted pizzas prior to becoming ill. The outbreak  spanned 10 states, including Illinois (1), Kentucky (3), Missouri (2), New York (2), Ohio (1), Pennsylvania (1), South Dakota (1), Tennessee (8), Virginia (1), and Wisconsin (1). While all of the victims of the General Mills E. coli outbreak have fortunately recovered so far, at least half of them did require hospitalization. But the General Mills Jeno’s and Totino’s frozen meat pizza E. coli outbreak could be more extensive because according to the Center for Disease Control (CDC), for every case of E. coli that is reported, two go unreported.

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Breast cancer patients are not getting all the information they need to make educated treatment decisions.  A new study—paid for by the National Cancer Institute—revealed most doctors don’t discuss breast reconstruction options with women prior to cancer surgery, depriving them of key information that can impact whether to have an entire breast or just a lump removed.  One-third of the 1,178 women in the study—surveyed three months after surgery from 2001 to 2003—said surgeons discussed cosmetic remedies with them in advance.  Two-thirds said reconstruction never came up with general surgeons before surgery.  Younger and more educated women were more likely to discuss reconstruction options.  The question of who initiated the topic—patient or doctor—was not asked.  Women who see breast specialists rather than general surgeons may be more apt to receive plastic surgery consultations.   Dr. Sameer Patel, a reconstructive surgeon at the Fox Chase Cancer Center in Philadelphia, said some doctors are too focused on the medical part of the decision about what operation to have.  “They’re trying to take care of the cancer, and that (cosmetic impact) takes a back seat,” he said.

When the topic was discussed, women were four times more likely to choose mastectomy, possibly because of the reconstruction options, which include implants not available for correcting defects left following lumpectomies; however, mastectomies can be a suspicious choice since breast-conserving lumpectomies generally suffice.  When cancer has not widely spread, most women opt for lumpectomy; however, some patients need or prefer mastectomy.  Breast cancer is the most common major cancer in American women with over 178,000 new cases expected this year in the U.S. and over 1 million worldwide. 
”Our point is not to say that one decision is better than another, but that women need to know all their options,” said Dr. Amy Alderman, the University of Michigan plastic surgeon who led the study.  “There are positives and negatives to both. We shouldn’t be paternalistic and tell patients, ‘This is what you need.’”  Dr. H. Kim Lyerly, a breast surgeon and director of Duke University’s Comprehensive Cancer Center, agreed.  The study is the second recent report to call attention to the often-neglected cosmetic consequences of cancer surgery.  Studies at last week’s San Antonio Breast Cancer Symposium also discussed limited options for millions left with dimpled or cratered breasts following lumpectomies.  Doctors say the latest study, conducted in over 100 hospitals in Detroit and Los Angeles, may overstate the doctor-patient communication problem, but acknowledge that one exists.

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Drug resistant MRSA is on the rise, and some scientists believe antibiotic overuse in animal agriculture is a major reason for this phenomena.  Now, the consumer advocacy group Keep Antibiotics Working has asked the Food & Drug Administration (FDA) to take steps to curb this dangerous practice.   Yes despite the growing evidence that antibiotic overuse in animal farming is detrimental, federal regulators, like the FDA, seem unwilling to do anything about the practice.

It has long been recognized that the overuse of antibiotics to treat minor ailments has helped to encourage the development of drug-resistant pathogens.  Because of that, many doctors have drastically cut back on the amount of antibiotics they prescribe.  But according to Keep Antibiotics Working, the use of the drugs within the livestock industry is an even bigger threat to public health.  According to the group, about 70 percent of the antibiotics used in the livestock industry are used in a “non-therapeutic” way.   For instance, antibiotics are a common ingredient in feeds to promote growth and compensate for unsanitary animal living conditions.  According to the group, this type of antibiotic use exposes bacteria to low levels of the drugs for an extended period of time – the ideal conditions for allowing pathogens to develop antibiotic resistance.

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The decision of Cigna Corporation to deny coverage for a teenage girl’s liver transplant likely killed her.   The family of Nataline Sarkisyan, a 17-year old leukemia patient, blamed Cigna on Friday for her death, saying the health insurance company’s initial refusal to pay for a liver transplant contributed to her death.  “They took my daughter away from me,” said Nataline’s father, Krikor, at a news conference at his lawyer’s office.  Apparently, the Philadelphia-based insurer had initially refused to pay for the procedure, saying it was experimental; however, the company reversed its decision on Thursday when approximately 150 nurses and community members rallied outside of its office in Los Angeles’s suburban Glendale.  Cigna’s change of decision came too late and Nataline died hours later.

According to family attorney Marl Geagos, Cigna “maliciously killed” Nataline because it did not want to bear the expense of her transplant and aftercare.  Geagos did not say when or in what court he would file the civil lawsuit, but said he would ask the district attorney’s office to press murder or manslaughter charges against Cigna, an allegation that one legal expert described as difficult to prove and “a little bit of grandstanding.” 

A district attorney’s office spokeswoman declined to comment, saying it would be inappropriate to do so until Geragos submits evidence supporting his request.  The family’s “loss is immeasurable, and our thoughts and prayers are with them,” Cigna said in a news release Friday.  “We deeply hope that the outpouring of concern, care, and love that are being expressed for Nataline’s family help them at this time.”

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Another magnetic toy set has been recalled amid fears that powerful magnets could cause intestinal injuries if they are swallowed.  This time, Super Magnets manufactured in China and imported by Man’s Trading Company of Brisbane, California are being recalled after it was discovered that the magnet on the bottom of the small panda toy are likely to detach, according to the Consumer Product Safety Commission (CPSC).  So far, no injuries have been reported in relation to the defective Super Magnet toys.

Magnetic play sets are among some of the most dangerous toys on the market.  Magnetix Building Sets were the first magnetic play sets subject to a large scale recall in 2006, following the death of a toddler who swallowed a magnet that had come loose from its casing.   The magnets in Magnetix and so many other similar sets are high-energy neodymium iron boron magnets.  If a child swallows more than one of these powerful magnets, they can be attracted to each other while in the intestinal tract. As a result, the magnets clump together, causing the intestines to twist. This can cause intestinal blockages, bowel perforations and even death. By the time the CPSC issued its first Magnetix recall in 2006, it had received 34 reports of injuries related to the toy, including one death.  Since the Magnetix incident, other magnet play sets have been recalled.  Over the summer,   Mattel  issued recalls for 18 million other magnetic toys in several popular lines including Polly Pockets and Batman.

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Bayer Diabetes Care has initiated a voluntary market recall of test strips—or sensors—that are used exclusively with the Contour TS Blood Glucose Meter.  In the course of its routine quality control monitoring processes the Bayer Diabetes Care identified a manufacturing issue with defective devices from specific lots.  The defect could result in blood glucose readings with a positive bias that is outside of their product specifications and test results may demonstrate results 5-17% higher.  This problem is with the strips only—and only with specific test strips used with the Contour TS Blood Glucose Meter—and is unrelated in any way to the Contour TS meter itself.  Also, the Contour TS test strip recall has no impact on the performance of strips used with other Bayer meters including the Ascensia Contour and Ascensia Breeze2 systems.

The affected Contour TS strips were produced during the initial manufacturing process on new manufacturing equipment designed for the new Contour TS strips.  The cause of the problem has been identified and corrective actions have already been implemented, including incorporating additional quality control measures to prevent recurrence.  “The quality of our products and the results our customers receive are very important to Bayer and, as such, we are notifying regulatory authorities, healthcare professionals and customers in the countries where Contour TS is marketed—France, Austria, Turkey, Korea, Mexico, and predominantly through mail order channels in the United States,” said Bayer in a prepared statement.

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Medtronic Inc., the maker of the defective Sprint Fidelis Defibrillator Lead, announced last week that it had reached a settlement agreement regarding another of its faulty medical devices.   The company has agreed to pay out $114 million to settle product liability lawsuits filed as the result of injuries cased by its malfunctioning Marquis line of implanted cardiac defibrillators.  Despite the huge settlement agreement, Medtronic  said it does not admit liability in the litigation.

Implantable cardioverter defibrillators, or ICDs, provide shocks to stop hearts from potentially dangerous rapid beating. They treat patients at risk for sudden cardiac death, which is the leading natural cause of death in the U.S.   In February 2005, Medtronic warned of a potential battery shorting problem in various Marquis-brand defibrillators.   According to the Wall Street Journal, 11,000 of the machines were surgically removed and replaced with a different device in the U.S.  and 2,000 more such removals took place overseas.  The Food & Drug Administration (FDA) classified Medtronic’s action as a Class II recall. In a Class II recall, there is either a possibility that the device will cause temporary or reversible health problems, or there is a remote chance that the device will cause serious health problems.

Plaintiffs in the suits against Medtronic argued that the company knew for years that there was a potential for product defects but sold its stock of potentially defective devices and didn’t advise patients that safer devices were available. The company has argued that it fulfilled every obligation in terms of reporting the problem, including seeking and receiving FDA approval in 2003 to implement battery design changes.  Yet in spite its claims that it acted properly, Medtronic is now settling thousands of defective Marquis Defibrillator Lawsuits.    The company will pay a total of $114 million, as it settles 2,682 cases for $95.6 million as well as $18.5 million in attorneys’ fee.

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A canned green bean recall has been issued amid botulism fears. New Era Canning Company in Michigan said Friday that it was voluntarily recalling 1,026 cans of green beans because they may be contaminated with bacteria that cause botulism, a life-threatening illness.  New Era Canning Company said it was recalling 171 cases of GFS (Gordon Food Service) Fancy Blue Lake Cut Green Beans with the lot code 19-H-7FL and UPC 939-0111-873.  Each case contained six cans in six-pound, five-ounce sizes.  The canned green beans were distributed to food service customers in Alabama, Arkansas, Georgia, Illinois, Indiana, Kentucky, Mississippi, Missouri, North Carolina, Tennessee, and Virginia and were sold through GFS Marketplace stores in Indiana, Kentucky, and Tennessee.  The potential contamination was discovered through testing by the Food and Drug Administration (FDA).

Clostridium botulinum can cause life-threatening illness or death; however, no illnesses have been reported to date.  Consumers should not eat the beans even if they do not look or smell spoiled.  “New Era Canning in conjunction with the U.S. Food and Drug Administration and the Michigan Department of Agriculture is thoroughly evaluating all processes and procedures to determine the cause of the problem,” the company said.

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