California Assembly Approves PFOA Ban on Food Wraps

The Associated Press is reporting that the California Assembly has reversed itself and approved a bill  to limit the amount of the chemical Perfluorooctanoic Acid (PFOA) that has been linked to cancer in food packaging.  The measure—by Senator Ellen Corbett-Democrat-San Leandro—would permit no more than 10 parts per billion (ppb) of PFOA in food packing such as fast-food wrappers, pizza boxes, and beverage containers.

The Environmental Protection Agency (EPA) considers PFOA potentially carcinogenic and says businesses should voluntarily stop using it by 2015.  A spokeswoman for Corbett said the bill would make California the first state to essentially ban use of the compound in food containers; 10 ppb is the smallest PFOA amount detectable by tests.  Although the Assembly rejected the bill last week, lawmakers reconsidered it after Corbett agreed to make a minor amendment.  Yesterday’s vote of 42-29 returned the bill to the Senate for a vote on Assembly amendments. (more…)

Two Studies: Similar Results, No Benefits from Stroke Drugs

Two recently-released, separate studies on medications used in the prevention and treatment of stroke both question the benefit of blood pressure medicine and a popular blood thinner for use in the prevention of stroke recurrence.  In the first study, patients who were taking the blood pressure drug Micardis (telmisartan) were no less likely to have another stroke than those patients who were taking a placebo.  The second study found that when aspirin was combined with the anti-platelet drug Persantine (dipyridamole), the combination also performed no better than the standard anti-clotting treatment Plavix (clopidogrel)for reducing the chance of stroke.

“We found no evidence that either of the two treatments was superior to the other in the prevention of recurrent stroke,” said Ralph Sacco of the University of Miami.  Sacco led the study.  “Even though, in science, you always strive to find a superior treatment, in this case it gives us options for treatment depending on the patient and their response to the different medications.”  Both research papers were released online by the New England Journal of Medicine and were based on the “Profess” study.  The Profess study reviewed data from 20,332 patients from 695 medical centers located in 35 countries. (more…)

Maple Leaf Foods Takes Full Blame for Listeriosis Outbreak

Maple Leaf Foods Chief Executive, president Michael McCain, said in a news conference that his company is fully accountable for a massive listeriosis outbreak, which has been linked to deaths of 15 people in Canada.  Maple Leaf is Canada’s biggest meat processor.  “The buck stops right here,” McCain said in a news conference.  “We have excellent systems and processes in place but this week it’s our best efforts that failed—not the regulators, not the Canadian food safety system,” McCain said.  “I emphasize this is our accountability and it’s ours to fix, which we are taking on fully,” he added.

The company is facing a number of class action suits and has withdrawn all 220 or so products made at its Toronto plant as a precaution.  The recall is one of Canada’s largest-ever food recalls.  Samples of two deli meats produced at the Toronto plant tested positive for the same strain of listeria bacteria that sickened dozens of Canadians this summer, including 15 people who have since died.  Meats from the plant were shipped to nursing homes, hospitals, restaurants, and stores. (more…)

Stryker Corp. Sues Over Federal Subpoena

Stryker Corp., the maker of hip implant components recalled earlier this year, is claiming that it is being harassed by two government agencies.  In a lawsuit filed in U.S. District Court in New Jersey on Aug. 15, the device maker claims that a subpoena served by the U.S. Department of Justice and the U.S. Department of Health and Human Services’ Office of Inspector General represents an “abuse of process”.

In October 2007, Stryker settled with the U.S. Attorney’s Office an earlier investigation in which its orthopedics division was allegedly paying surgeons kickbacks for using Stryker products. At the same time, four other orthopedic-implant-makers also settled and paid $310 million in fines. Stryker cooperated in that earlier investigation and did not pay a fine. (more…)

Study Reveals Fertility Treatments Induce Gene Mutations in Males

Chinese researchers are reporting that the use of in vitro fertilization (IVF) or another assisted fertility technique called that is called intracytoplasmic sperm injection (ICSI) to conceive appears to increase the odds of Y-chromosome defects or “microdeletions” in male offspring.  Although this study was small, it “at least sounds an alarm about the genetic safety of assisted reproductive technology,” the investigators conclude.

This means that the chromosomal defects, or deletions, could result in defective sperm production and possibly also hypospadias.  Hypospadia is a relatively common congenital malformation of the male sex organs in which the urinary outlet, or urethra, does not open through the glans of the penis, but rather, develops on the underside of the penis.  This defect makes it difficult for the patient to urinate normally and to control one’s stream of urine.  Generally, hypospadia occurs because of a hormonal imbalance or deficiency that takes place at a critical point in fetal development prior to birth.  Early corrective surgery is generally called for before the child reaches the age of three. (more…)

Oklahoma E. Coli Outbreak is Out of Control

Oklahoma state health officials are finally able to confirm that a type of E. coli bacteria has been found in 10 of the patients who were sickened by a severe illness in northeastern Oklahoma.  The E. coli outbreak has taken the life of one man—26-year-old Chad Ingle—and has caused the hospitalizations of at least 41 others and dozens more have reported being ill. Patients are reporting symptoms of food poisoning along with a very severe and bloody form of diarrhea Also, a number of children are undergoing dialysis due to kidney failure as a result of their illnesses.  The illness has been characterized as a “severe illness outbreak.”

Ingle was discharged from Tulsa’s St. Francis Hospital last Friday after becoming sick on Wednesday, he returned to the hospital the following morning when his condition worsened; he died soon after. (more…)

Vytorin Cancer Controversy Far from Over

News earlier this summer that Vytorin had been tied to a higher risk of cancer by a newly published  study quickly faded from the headlines.  Merck and Schering-Plough’s reassurance that the cancer finding in the SEAS study was an anomaly apparently squashed much discussion of the issue - at least in the media.  But a new report on Fortune.com seems to indicate that a change is coming, and Vytorin could face new scrutiny next week

The SEAS study investigated the effects of Vytorin in patients with partial blockages of the aortic valve of the heart, known as aortic stenosis. Left untreated, it can progress to death from heart failure or cardiac arrest. According to the SEAS findings,  Vytorin did little to help patients with aortic stenosis avoid other heart problems. (more…)

Byetta Pancreatitis Concerns Could Delay Long-Acting Version

A much-anticipated long-acting form of Byetta might have problems gaining approval now that the current form of the diabetes drug has been associated with pancreatitis.  Amylin Pharmaceuticals had hoped that once-weekly Byetta would be approved by 2010, but now there is a good chance that the Food & Drug Administration (FDA) will want more information on the medication’s side effects before it makes a decision.

Byetta was approved by the FDA in 2005 to help type 2 diabetics better control blood sugar when other drugs were not adequate. The twice-daily injection is a synthetic form of a lizard hormone that boosts the production of insulin. Insulin is vital to controlling blood sugar levels. (more…)

Deaths Prompt Simplicity Bassinet Warning, But No Recall

A popular Simplicity bassinet has been implicated in two infant deaths since last September, but has yet to be recalled. The Consumer Product Safety Commission (CPSC) has warned parents to stop using the Simplicity 3-in-1 and 4-in-1 convertible bassinets because they contain metal bars spaced farther apart than federal standards allow. However, the company that now owns Simplicity has defied the CPSC and is refusing to recall the deadly bassinets.

Last September, a Simplicity Winnie the Pooh 4-in-1 Bassinet claimed the life of a 4-month-old Missouri girl. The infant had slipped out the side of the bassinet between a lower horizontal railing and her mattress, and had become trapped in a 4-inch gap between the railing and top of the mattress. The little girl’s death was ruled an “accidental positional asphyxiation.” (more…)

First Class Action Lawsuit Over Maple Leaf Listeria Outbreak

Over 1,100 people have initiated a class action lawsuit against Canada’s Maple Leaf Foods in response to a growing Listeriosis outbreak associated with Maple Leaf’s Toronto meat plant.  To date, the meat contamination has resulted in 29 cases of Listeriosis, including 15 deaths, according to the Public Health Agency of Canada.

The lawsuit involves people who have suffered illness, death, mental distress, or financial losses as a result of the tainted meat and recall; allegations have not yet been proven in court.  This past weekend, confirmation was announced that meat tainted with outbreak’s source.  Maple Leaf upgraded a precautionary recall of 23 of its products issued last week to all 220 of its packaged meats from the plant.  That second recall was issued Monday. (more…)

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