Lilly to Pay $15 Million to Settle Alaska Zyprexa Lawsuit
In what's seen as a surprise announcement, Eli Lilly and the state of Alaska announced Wednesday that the drug maker has agreed to pay $15 million to settle a state lawsuit claiming its schizophrenia drug Zyprexa caused users to develop diabetes.
The announcement comes three weeks into a trial in Anchorage. The case hadn't reached the jury, but it was expected that closing arguments would take place this week, The New York Times reported.
In the statement released Wednesday, Lilly did not admit wrongdoing.
The state of Alaska sued Lilly to recover the cost of medical care allegedly generated by Medicaid patients who developed diabetes while taking Zyprexa. A number of other states have sued Lilly with similar claims, or are taking part in settlement talks led by federal prosecutors in Pennsylvania.
Lilly has already shelled out $1.2 billion to settle 30,000 individual lawsuits from people who said they developed diabetes while taking Zyprexa, the Times reported. Since the drug was introduced in the U.S. in 1996, more than 23 million people have taken it.
FDA Issues Draft Guidelines for Drug-Eluting Stents
Draft guidelines to help in the development, testing and manufacture of coronary drug-eluting stents were issued Wednesday by the U.S. Food and Drug Administration.
Stents are hollow mesh cylinders used to prop open arteries that were once blocked. Drug-eluting stents have a coating that slowly releases a drug to prevent the growth of scar tissue.
For more than two years, there has been growing concern about the possibility of dangerous clot formation in some patients. Since 2006 when such concerns were raised, medical societies have urged patients to take anti-clotting drugs for at least a year after the devices are implanted, the Associated Press reported.
The proposed guidelines recommend that the device manufacturers conduct large, analytic studies of the devices, the AP said.
The guidelines also include a recommendation that a device maker should track patients for up to five years after a drug-eluting stent receives FDA approval, the wire service said. Public comment on the draft guidelines is being accepted for 120 days.
The FDA has so far sanctioned drug-coated stents made by three manufacturers: Boston Scientific, Medtronic, and Johnson & Johnson. Each year in the United States, about 650,000 patients receive this type of stent.
New Yorkers Gain 10 Million Pounds in Two Years
The Big Apple is getting much bigger.
Between 2002 and 2004, New York City residents gained a total of more than 10 million pounds, about 173,500 residents became obese, and more than 73,000 were diagnosed with diabetes, says a study by the city's health department.
During those two years, the city's rates of obesity and diagnosed diabetes both increased by 17 percent, compared to a six percent increase in obesity and no increase in diabetes diagnoses nationwide.
In New York City, obesity increased by 20 percent among whites and by 14 percent among Hispanics. Among older residents, the obesity rate increased by 28 percent, and shot up by 33 percent among foreign-born residents.
There were large increases in diabetes diagnoses among both U.S.- and foreign-born residents, 15 percent and 26 percent, respectively. The highest diabetes rates were among black and Hispanic adults, and among people in low-income neighborhoods.
In another study, health department researchers said calories from sodas and other sugary drinks are a major cause of the city's obesity epidemic. Overall, 27 percent of New York City adults consume an average of nearly two sugar-sweetened sodas a day, which contain nearly 300 calories.
The studies appear in the journal Preventing Chronic Disease and in the Journal of Urban Health.
Three More Countries Recall Heparin
Denmark, France and Italy have announced recalls of the blood-thinning drug heparin or its ingredients due to suspected contamination with a chemical called oversulfated chondroitin sulfate. Similar recalls have been announced in Germany and the United States.
There have been no adverse reports of people taking heparin in Denmark, France or Italy, the Wall Street Journal reported. Officials in those countries believe oversulfated chondroitin sulfate is the contaminant, but that hasn't been confirmed.
The U.S. Food and Drug Administration says it knows of 19 people who died after taking heparin, apparently from allergic reactions. Hundreds of other patients have become ill.
FDA officials are "in communication with the regulatory authorities in [European] countries and are still vigorously pursuing our investigation," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a prepared statement, the Wall Street Journal reported.
It's believed that Chinese-made heparin ingredients are the source of the contamination.
FDA Warns Men Not to Use 'Blue Steel' or 'Hero' Products
Consumers shouldn't buy or use "Blue Steel" or "Hero" products sold as treatments for erectile dysfunction or sexual enhancement because they are considered unapproved drugs and haven't been proven safe or effective, the U.S. Food and Drug Administration warned.
The products, promoted and sold over the Internet, contain undeclared ingredients that may have a dangerous effect on a person's blood pressure, the agency said. The products are labeled as all natural dietary supplements but don't qualify as such because they contain undeclared and unapproved substances similar in chemical structure to sildenafil, the active ingredient in Viagra, the FDA said.
"Because these products are labeled as 'all natural dietary supplements,' consumers may assume that they are harmless and pose no health risk," Dr. Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, said in a prepared statement. "But an unsuspecting consumer with underlying medical issues may take these products without knowing that they can cause serious side effects and interact in dangerous ways with drugs that a consumer is already taking."
Men with diabetes, high blood pressure, high cholesterol, or heart disease often take prescription drugs that contain nitrates. Erectile dysfunction is common in these men, but they're advised against taking Viagra or similar drugs. Instead, some of these men look for "all natural" products to treat erectile dysfunction.
Any men who have taken Blue Steel or Hero products should stop using them and consult their doctor if they've had problems that may have been caused by the products, the FDA said.
Switching Off Genes May Put Cancers to Sleep: Study
It may be possible to switch off genes and put cancer tumors "to sleep" instead of having to treat patients with chemotherapy, suggests a study by American and Australian researchers.
In tests with mice, the scientists found that by switching a gene called Id1 off or on, it was possible to either shrink or encourage growth in certain kinds of breast tumors. They also found that breast cancers with high levels of the Id1 gene became very aggressive and were likely to spread to other parts of the body, Agence France-Presse reported.
"We also showed that if we genetically switch off the Id1 gene in an established tumor, those mice live much longer than mice with continual Id1 expression in their tumor," said Dr. Alex Swarbrick of the Garvan Institute in Sydney, Australia. "In fact, about 40 percent of them were cured and the tumors just shrank away."
The findings, published in the journal Proceedings of the National Academy of Sciences, suggest it may be possible to target genes that switch off cancers in order to put tumors to sleep, Swarbrick told AFP.
"You induce a terminal sleep, and then the immune system just gobbles [the tumors] up," he said.