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Woman's blood alcohol content topples state records

From the Rapid City Journal:

A Sturgis woman had a record-setting blood alcohol level of .708 when she was found on Dec. 1 behind the wheel of a stolen vehicle.

Her blood alcohol was almost nine times the level at which South Dakota authorities presume a person is intoxicated.

Checks with local and state labs where blood alcohol levels are tested suggest Engle's reading may be the highest ever recorded in South Dakota.

Meade County State's Attorney Jesse Sondreal's research indicates that a blood alcohol level of .40 is considered a lethal dose for about 50 percent of the population.

"Engle's was almost double that," Sondreal said.

Posted: 12/30/2009 10:01:00 AM

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Alcohol substitute that avoids drunkenness and hangovers in development

From the Telegraph (UK):

An alcohol substitute that mimics its pleasant buzz without leading to drunkenness and hangovers is being developed by scientists.

The new substance could have the added bonus of being "switched off" instantaneously with a pill, to allow drinkers to drive home or return to work.

The synthetic alcohol, being developed from chemicals related to Valium, works like alcohol on nerves in the brain that provide a feeling of wellbeing and relaxation.

But unlike alcohol its does not affect other parts of the brain that control mood swings and lead to addiction. It is also much easier to flush out of the body.

Finally because it is much more focused in its effects, it can also be switched off with an antidote, leaving the drinker immediately sober.

The new alcohol is being developed by a team at Imperial College London, led by Professor David Nutt, Britain's top drugs expert.

Prof Nutt and his team are concentrating their efforts on benzodiazepines, of which diazepam, the chief ingredient of Valium is one.

Thousands of candidate benzos are already known to science. He said it is just a matter of identifying the closest match and then, if necessary, tailoring it to fit society’s needs.

Eventually it would be used to replace the alcohol content in beer, wine and spirits and the recovered ethanol (the chemical name for alcohol) could be sold as fuel.

Professor Nutt believes that the new drug, which would need licensing, could have a dramatic effect on society and improve the nation's health.

Getting the drug approved could be hard for the team as clinical trials are expensive, and it is not clear who would pay for them, according to Professor Nutt.

Posted: 12/29/2009 9:22:00 AM

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Lead poisoning among children causes factory closure

From Baltimore News.Net:

A battery factory in the south of China has been closed down due to a lead poisoning scare.

Excessive amounts of lead in the body can harm the nervous and reproductive systems and cause high blood pressure and anemia. In severe cases, it can lead to convulsions, coma and death.

44 children living in the area were found to have excessive levels of lead in their blood before the city's environmental bureau took over the battery plant to conduct tests on the factory's water discharge.

Officials found lead content exceeding provincial safety standards in the water.

Posted: 12/29/2009 9:05:00 AM

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U.S. Fines Prompt Drug Makers to Police Off-Label Marketing

From The Wall Street Journal:

U.S. government fines have made big drug makers "more sensitive than we've ever been" about preventing illegal promotion of their drugs, the chief executive of AstraZeneca PLC said in an interview.

AstraZeneca in September reached a preliminary agreement to pay $520 million to settle a U.S. investigation into its marketing of the schizophrenia drug Seroquel, including allegations that the company promoted the drug for uses for which it isn't approved by the Food and Drug Administration. This practice, called "off-label marketing," is illegal.

AstraZeneca officials have declined to say whether the company will admit wrongdoing as part of the settlement, the terms of which are still under discussion. In an interview in London, chief executive David Brennan said: "We don't promote products off-label."

But he said off-label marketing has become "a much bigger issue in the last few years as a result of the government's position on this."

A number of drug companies, including Pfizer Inc. and Eli Lilly & Co., have reached large settlements in recent months with U.S. investigators probing marketing practices.

Doctors are free to prescribe drugs any way they see fit, but drug makers aren't allowed to promote them for unapproved uses.

Controversy has long dogged Seroquel. AstraZeneca is facing thousands of lawsuits filed by patients who allege that Seroquel caused them to develop health problems including diabetes.

Earlier this year, lawyers representing those plaintiffs released documents that they said showed that AstraZeneca executives discussed promoting the drug for unapproved uses. The documents cited plans to "broaden Seroquel use on and off-label," including among adolescents and patients with Parkinson's and Alzheimer's disease, at medical meetings, in sales calls and with patient-advocacy groups.

Posted: 12/22/2009 10:10:00 AM

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Report: marijuana, prescription drug use up among teens

From The Christian Science Monitor:

A national study widely considered to be an important indicator of youth drug abuse showed progress with some drugs but widespread problems with marijuana and prescription or over-the-counter drugs.

The study, compiled by the University of Michigan for the federal National Institute on Drug Abuse, found that 7 of the 10 drugs most abused by high school seniors are prescription or over-the-counter drugs acquired primarily from teens’ friends or relatives.

The study, released Monday, focuses on eighth-, 10th-, and 12th-graders. Within that group, use-rates for some substances have improved – notably hallucinogens and cocaine by 12th graders and methamphetamines among eighth graders. Cigarette use, too, continued to drop significantly. In 1997, 36.5 percent of 12th-graders said they'd smoked a cigarette during the past month. This year, 20.1 percent said they had.

But use of inhalants by 10th-graders increased, and use of marijuana across all three grade-levels increased. The study attributed the rise, at least in part, to the growing acceptance of marijuana use for medicinal purposes. That trend has made the drug appear less dangerous to teens, the study said.

Posted: 12/15/2009 3:45:00 PM

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Poor Children Likelier to Get Antipsychotics

From The New York Times:

New federally financed drug research reveals a stark disparity: children covered by Medicaid are given powerful antipsychotic medicines at a rate four times higher than children whose parents have private insurance. And the Medicaid children are more likely to receive the drugs for less severe conditions than their middle-class counterparts, the data shows.

Those findings, by a team from Rutgers and Columbia, are almost certain to add fuel to a long-running debate. Do too many children from poor families receive powerful psychiatric drugs not because they actually need them — but because it is deemed the most efficient and cost-effective way to control problems that may be handled much differently for middle-class children?

The questions go beyond the psychological impact on Medicaid children, serious as that may be. Antipsychotic drugs can also have severe physical side effects, causing drastic weight gain and metabolic changes resulting in lifelong physical problems.

On Tuesday, a pediatric advisory committee to the Food and Drug Administration met to discuss the health risks for all children who take antipsychotics. The panel will consider recommending new label warnings for the drugs, which are now used by an estimated 300,000 people under age 18 in this country, counting both Medicaid patients and those with private insurance.

Meanwhile, a group of Medicaid medical directors from 16 states, under a project they call Too Many, Too Much, Too Young, has been experimenting with ways to reduce prescriptions of antipsychotic drugs among Medicaid children.

They plan to publish a report early next year.

The Rutgers-Columbia study will also be published early next year, in the peer-reviewed journal Health Affairs. But the findings have already been posted on the Web, setting off discussion among experts who treat and study troubled young people.

...as Congress works on health care legislation that could expand the nation’s Medicaid rolls by 15 million people — a 43 percent increase — the scope of the antipsychotics problem, and the expense, could grow in coming years.

The F.D.A. has approved antipsychotic drugs for children specifically to treat schizophrenia, autism and bipolar disorder. But they are more frequently prescribed to children for other, less extreme conditions, including attention deficit hyperactivity disorder, aggression, persistent defiance or other so-called conduct disorders — especially when the children are covered by Medicaid, the new study shows.

Although doctors may legally prescribe the drugs for these “off label” uses, there have been no long-term studies of their effects when used for such conditions.

The Rutgers-Columbia study found that Medicaid children were more likely than those with private insurance to be given the drugs for off-label uses like A.D.H.D. and conduct disorders. The privately insured children, in turn, were more likely than their Medicaid counterparts to receive the drugs for F.D.A.-approved uses like bipolar disorder.

Posted: 12/15/2009 11:50:00 AM

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Reconsidering antiepileptic medications as a treatment for bipolar disorder

From the Los Angeles Times:

A study coming out in tomorrow’s edition of Archives of General Psychiatry may prompt doctors and patients to reconsider the merits of using antiepileptic drugs to treat people with bipolar disorder.

Just last year, the U.S. Food and Drug Administration issued an alert that antiepileptic drugs -- such as Neurontin (generic name gabapentin), Lyrica (pregabalin), Topamax (topiramate) and Tegretol (carbamazepine) -- increased the risk of suicidal thoughts and behaviors. That’s particularly important for patients with bipolar disorder, because they already have a higher risk of suicide compared to healthy people.

But the new analysis finds that bipolar people who took one of 11 antiepileptic medications had the same rate of suicide attempts -- 13 per 1,000 patients per year -- as those who didn’t take any drugs for their condition. That rate was slightly lower than for bipolar people who took lithium (18 suicide attempts per 1,000 patients per year). It was also much lower than the rate of suicide attempts among bipolar people in the year before they began taking antiepileptic medications (72 per 1,000 patients per year).

The findings are based on records of 47,918 patients with bipolar disorder who were included in the PharMetrics medical claims database. The study was conducted by researchers from the Center for Health Statistics at the University of Illinois at Chicago and the Columbia University College of Physicians and Surgeons in New York.

Posted: 12/9/2009 9:15:00 AM

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Feds probing chemical levels in Zhu Zhu Pets

UPDATED - from msnbc.com:

Zhu Zhu Pets — one of the holiday season’s hottest toy crazes — do not violate safety standards, federal toy regulators said Monday after a consumer group raised concerns over the presence of a heavy metal on one model.

The toy “is not out of compliance” with a U.S. toy safety law that went into effect this year, a spokesman for the U.S. Consumer Product Safety Commission told The Associated Press. The agency did not test the toy.

The California-based consumer group GoodGuide raised concerns starting Saturday over the presence of a potentially harmful heavy metal in a Mr. Squiggles model of the robotic hamsters. The group said its testing found antimony — a heavy metal that can cause vomiting if eaten, and heart and lung problems if breathed — on the furry toy’s hair and nose in levels that exceeded new federal limits.

But those claims fell apart Monday, when GoodGuide said the way it got its test results — using a special gun that shoots X-rays into a toy and gives a reading for how much lead, antimony or other substances are in the material — is not recognized by the CPSC for judging whether a toy is hazardous.

Instead, the CPSC tests how much of a heavy metal would actually seep out if a child sucked or swallowed a toy — not just how much of a potentially dangerous substance a toy contains.

“While we accurately reported the chemical levels in the toys that we measured using our testing method, we should not have compared our results to federal standards,” GoodGuide said in a written release. “We regret this error.”

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From msnbc.com:

The Consumer Product Safety Commission has opened an investigation into the popular Zhu Zhu Pets toy because it may contain higher-than-allowed levels of antimony, a heavy metal which if ingested can make children sick, NBC News reported.

The CPSC probe came after San Francisco-based GoodGuide named Zhu Zhu Pets hamsters one of the top-selling toys with low ratings after finding the chemical on the hair and nose of one of the toy hamsters, called Mr. Squiggles.

The group assigned the toy, aimed at 3- to 10-year-olds, a rating of 5.2 on a 10-point scale.

On prolonged exposure, antimony — which is used in textiles and plastics to prevent them from catching fire — can cause lung and heart problems, ulcers and diarrhea.

But the toy's maker, St. Louis-based Cepia LLC, insisted in a statement that its Mr. Squiggles toy is "absolutely safe" and has passed rigorous testing. The company said it was contacting GoodGuide to share its testing data and determine how the report was founded.

Antimony was measured at 93 parts per million in the hamster's fur and at 106 parts per million in its nose. Both readings exceed the allowable level of 60 parts per million, said GoodGuide CEO Dara O'Rourke, an associate professor of environmental science at the University of California, Berkeley.

O'Rourke said GoodGuide's test results, released Friday, also indicated the possibility that some toys contained phthalates, chemicals that were subject to tougher standards in the Consumer Protection Safety Improvement Act passed last year.

The CPSIA created some of the toughest lead limits in the world and banned certain phthalates in toys, and included mandatory limits on other heavy metals, such as antimony.

Posted: 12/7/2009 1:41:00 PM

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New Drug Application Submitted to FDA for Tapentadol Extended Release Tablets for Management of Chronic Pain

From Pharmaceutical Processing:

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. has submitted a New Drug Application (NDA) to the FDA for tapentadol extended release (ER) tablets, an investigational oral analgesic for the management of moderate to severe chronic pain in patients 18 years of age or older.

Chronic pain, defined as pain that persists for long periods of time - usually greater than three months - is a significant medical challenge in the United States. According to the National Institutes of Health (NIH), an estimated 100 million Americans suffer from chronic pain. If undertreated, chronic pain can impair an individual's ability to carry out daily activities.

Tapentadol ER is a novel investigational, centrally acting oral analgesic that binds to mu-opioid receptors and inhibits norepinephrine re-uptake. Although the exact mechanism of action is not known, these two mechanisms, which affect established pain pathways, are thought to be responsible for pain relief with tapentadol.

The submission is based on a full clinical development program for tapentadol ER. The program includes Phase 3 double-blind, randomized, active-and placebo-controlled studies. These clinical trials explored the efficacy and safety of tapentadol ER for the treatment of moderate to severe pain in patients with chronic osteoarthritis and low back pain, as well as in patients with diabetic peripheral neuropathic pain. In addition, a one-year, active-control open-label Phase 3 safety trial also was included.

Data from these studies provide evidence that tapentadol ER has efficacy to reduce moderate to severe chronic pain compared to placebo. The data also provide evidence of long-term safety and tolerability of tapentadol ER.

The tapentadol ER tablet formulation is designed to provide a high degree of mechanical resistance, such as to crushing or chewing.

Posted: 12/3/2009 9:49:00 AM

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FDA likely to delay ruling on BPA

From the Journal Sentinel:

Despite months of additional study and a self-imposed timetable, the U.S. Food and Drug Administration likely will not release its ruling Monday on the safety of bisphenol A, a chemical used in thousands of household products that has been linked to developmental and behavioral problems.

Sources told the Journal Sentinel the agency instead is likely to ask for more time as its scientists consider hundreds of new studies on the chemical's effects.

Last year, relying on two studies paid for by BPA-makers, the FDA held the chemical was safe for all uses. But the FDA's own science board recommended that the agency had not considered enough of the other studies on the chemical. Earlier this year, the FDA said it would review its findings and set the Nov. 30 deadline.

Advocates for a ban on BPA viewed the prospect of a delay as a good sign, figuring if the FDA plans to maintain its earlier ruling the agency would not need more time.

Additionally, environmentalists were pleased at the recent appointment of Lynn Goldman, a pioneer in research on endocrine-disrupting chemicals and a leading voice for strong environmental health policy, to act as a part-time consultant to the FDA on the chemical.

Advocates of a ban, and packaging company executives who maintain BPA is safe, have anxiously awaited the new FDA ruling.

Posted: 12/2/2009 1:11:00 PM

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