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Inspection of Baxter Heparin Plant Finds Problems, As Baxter Expands Heparin Recall

Baxter International has now recalled all of its Heparin, as the number of reactions linked to the tainted drug have grown to at least 400, including 4 deaths. Meanwhile, an inspection of the Chinese plant that supplied raw Heparin to Baxter revealed problems, but it is unclear if they contributed to the tainted Baxter Heparin.

The Food & Drug Administration (FDA) has finished its inspection of the Chinese plant that had made a raw ingredient for Baxter Heparin. The FDA said it had found “irregularities” at that plant, but had not determined if they were responsible for the tainted Heparin. The agency also said it was also investigating two Chinese wholesalers that supplied crude Heparin to the Chinese plant, as well as those that sold raw ingredients to the wholesalers. (more…)

Auction Rate Preferred Bonds Latest ‘Safe’ Investment Hit by Credit Crunch

Auction rate preferred shares – an investment vehicle touted as safe and highly liquid – have turned out to be much riskier than some investors were led to believe. Auction rate preferred shares can be only sold during auctions, and because of turmoil in the credit markets and the actions of some investment banks, recent auctions have failed.

Many investors who bought auction rate bonds were led to believe that these vehicles could be easily redeemed, and now they are finding out otherwise. The situation is already getting the attention of state authorities. Massachusetts Secretary of State William Galvin on Feb. 20 asked nine fund companies for information about failed auctions that left investors unable to sell their holdings. Ohio Attorney General Marc Dann also told reporters last week his office may file lawsuits after state funds bought the securities. (more…)

Hepatitis Warning Issued to Thousands Treated at Nevada Endoscopy Center

The Endoscopy Center of Southern Nevada regularly reused syringes, a practice implicated in a Hepatitis C outbreak that has sickened 6 people, and thousands of people treated at the Las Vegas clinic are being told to get tested for Hepatitis C and HIV.   At least six people who received treatment at the Endoscopy Center of Southern Nevada have already tested positive for Hepatitis C, but health officials in the state have urged another 40,000 to be tested for the virus, as well as HIV.

The Hepatitis C virus may have been spread when clinic staff reused syringes and used a single dose of anesthesia medication on multiple patients, the district said. A syringe would become contaminated by the backflow of blood when patients with a blood-borne disease were injected with medication, health officials said. That syringe, in turn, would be reused to withdraw medication from a different vial. That vial could become contaminated and result in infection. (more…)

FDA Ignores Avastin Safety Issues, Approves it for Breast Cancer

Despite no evidence that it increases survival times, as well as concerns over its safety, the cancer drug Avastin has been approved by the Food & Drug Administration (FDA) to treat advanced breast cancer. The Avastin approval came despite a recommendation from an FDA advisory panel that the approved uses of Avastin not be expanded to include breast cancer.

Many in the medical community are disturbed that Avastin has been approved for breast cancer, as there are fears that it could signal a lowering of FDA standards. FDA approval for drugs targeted at cancer patients who have never been treated before is usually contingent upon data showing a drug extended, or improved the quality of, patients’ lives. Avastin showed neither in a study submitted by Genentech, though the drug did slow tumor growth. Some think the FDA’s Avastin decision opens the door for more cancer drugs to be approved for their tumor-shrinking capabilities, a development that has some cancer experts worried. “If FDA sets a precedent of approving a drug based on progression free survival, people are afraid they may stop looking at survival as the most important endpoint,” Dr. Kay Dickersin, director of the Center for Clinical Trials at Johns Hopkins University, told the Associated Press. (more…)

Policy Cancellation Costs Health Net $9 Million

Health Net Inc. has been ordered to pay $9 million to a California woman for illegally canceling her health insurance coverage after it learned she had been diagnosed with breast cancer. It is the first time that a health insurance company has been fined over its cancellation policies.

In the wake of the decision, Health Net said it would be implementing a freeze on policy cancellations that would last until the company sets up a third-party review panel to scrutinize cases. Health Net also said it would review its practices and the way its brokers and agents are trained. “Obviously we regret the way that this has turned out, but we are intent on fixing the processes to maintain the public trust,” a Health Net spokesperson told the Associated Press. (more…)

Beef Industry Tried to Scale Back Hallmark/Westland Beef Recall

Just hours after the Hallmark/Westland beef recall was announced this past Sunday, the beef industry tried to convince the US Department of Agriculture (USDA) to scale back the size of the recall.  Hallmark/Westland recalled 143 million pounds of meat after undercover video showed the company slaughtered “downer cattle” – animals too sick to walk or stand – without submitting them to USDA inspection first.  Downer cows are at higher risk of contracting mad cow disease, E. coli and other illnesses that can be passed on to people.

The Hallmark/Westland beef recall had already raised concerns over the USDA’s oversight of the beef industry.  Now, The Wall Street Journal report on the beef industry attempts to scale back the recall is raising questions about industry influence over the agency. According to The Wall Street Journal, on two occasions industry and USDA officials discussed the possibility of excluding from the recall Hallmark/Westland beef that was mixed with other suppliers’ meat and sent to retail and wholesale customers. The Wall Street Journal’s report is based on a memo obtained by the newspaper that was written by an employee of Olsson Frank Weeda Terman Bode Matz PC, a Washington law firm that represents several food companies. (more…)

A-Listers Warned of Hepatitis A Threat at New York Nightclub

A-list celebs Madonna, Gwyneth Paltrow, Demi Moore, Ashton Kutcher and others have been warned that they are at risk for Hepatitis A following Kutcher’s 30th birthday party at the New York City nightclub Socialista. The New York City Department of Health has warned the stars that they — and anyone else who made a visit to Socialista on three nights in early February — should get a Hepatitis A vaccine as a precaution.

According to the New York City Department of Health, a bartender who worked at the West Village nightclub on February 7, February 8 and February 11 has tested positive for Hepatitis A. Kutcher’s birthday party was held at Socialist on February 7. A health department official told The New York Times that as many as 1,000 other people might have been at Socialista on those nights. The restaurant has turned over lists of names from 30 to 40 reservations made on those nights, but the department has not gone through credit card receipts. (more…)

Consumers Lose in Medtronic Supreme Court Decision

Consumers lost some of their rights to sue the makers of defective medical devices after the US Supreme Court sided with Medtronic Inc. and ruled that Food & Drug Administration (FDA) pre-market approval of a medical device shields companies from state product liability lawsuits. In the case considered by the Supreme Court, Medtronic had argued that the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act that require 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 Supreme Court agreed. In his majority opinion, Justice Antonin Scalia wrote that permitting state juries to impose liability on the maker of an approved device “disrupts the federal scheme,” under which the FDA has the responsibility for evaluating the risks and benefits of a new device. Justice Scalia wrote that state tort law amounted to such an additional requirement. He said the 1976 law “speaks clearly to the point at issue,” regardless of the federal government’s previous or current positions. (more…)

Trasylol Faces More Scrutiny, as Two More Studies Find Higher Death Risk with Bayer Drug

Trasylol’s potential to cause deadly side effects has been confirmed by two more studies, one of which was funded by the drug’s maker, Bayer AG. The Bayer Trasylol study was actually completed prior to a September 2006 Food & Drug Administration (FDA) hearing on the drug, but was withheld by the drug maker. Bayer suspended sales of Trasylol at the request of the FDA after Canadian health officials halted a portion of a clinical trial after it was determined that patients in the study treated with Trasylol where more likely to die.

A spokesperson for the consumer advocacy group Public Citizen told the Associated Press that the latest Trayslol studies are convincing confirmation of the drug’s dangers. “I just don’t know how much further evidence you need,” said Dr. Sidney Wolfe. Wolfe added that federal health officials should pursue criminal charges against Bayer for withholding information from its own study from the FDA panel in 2006.

(more…)

Sears Settles Class Action Lawsuit over Tipping Stoves

Sears has agreed to settle a class action lawsuit over hazardous stoves that can tip over, resulting in serious injuries to consumers. According to several consumer groups, including Public Citizen, more than 100 people have been killed or injured from scalding and burns caused by hot foods and liquids spilling from stove tops, or from being crushed by the weight of a stove that has tipped over. Now Sears has agreed to install ant-tip brackets on all of its stove manufactured since 2000, something that could cost Sears over $500 million.

While consumer advocates, including Public Citizen, have said they are extremely pleased with the Sears settlement, they have called on the Consumer Product Safety Commission (CPSC) to take more action against tipping appliances and furniture. They say the CPSC has known about the problem for 20 years, but has done little about it. A spokesman at the CPSC told The New York Times that last year it listed the possible tipping of stoves, furniture and other household items as one of the five greatest hazards facing consumers. It recommended that consumers install brackets to secure ranges and urged the industry to apply its own voluntary safety standards. The commission believes these voluntary measures are working. (more…)

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