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Supplements for Athletes Draw Alert From F.D.A.

From The New York Times:

Federal regulators warned consumers on Tuesday not to use body-building products that are sold as nutritional supplements but may contain steroids or steroidlike substances, citing reports of acute liver injury and kidney failure.

The Food and Drug Administration said it issued the warning because of increased reports of medical problems in men who had used such products.

But except for naming eight specific supplements sold by a single company, the Food and Drug Administration did not provide much clear guidance to consumers on what other products to avoid. The F.D.A. acknowledged that it did not know how many products its warning affects.

Generally, the F.D.A. said, buyers should beware of body-building products that claim to enhance or diminish the effects of hormones like testosterone, estrogen or progestin. In particular, the agency said consumers should not buy products labeled with code words like “anabolic” and “tren,” or phrases like “blocks estrogen,” and “minimizes gyno.” The references to estrogen and “gyno” are meant to indicate the products do not have a feminizing effect on the body, like swelling breasts or shrinking testicles, which can be unwanted side effects of steroid use in men.

The F.D.A. cited eight popular products from American Cellular Labs, including Mass Xtreme and Tren Xtreme, that the agency found to contain hidden and potentially hazardous steroids. The agency sent a letter on Monday warning the company to make the products comply with federal regulations. Last week, federal agents in San Francisco executed search warrants for the company and for a San Francisco outlet of Max Muscle, a chain of sports nutrition stores, some of which sold the products cited by the F.D.A.

“We think that there may be a number of firms that are marketing similar products, if not products that are exactly the same,” Michael Levy, director of the Division of New Drugs and Labeling at the agency’s Center for Drug Evaluation and Research, said in a conference call with reporters on Tuesday. The agency, he said, is considering taking action against those firms as well.

The warning is part of a larger investigation into body-building products that contain hidden steroids, according to court documents in the American Cellular Labs case. A spokesman for Joseph P. Russoniello, the United States attorney for the Northern District of California, said he could not comment on open investigations.

But Travis Tygart, the chief of the United States Anti-Doping Agency, which oversees the drug testing of Olympic athletes, estimated that there could be 50 or more other brands on the market that contain the same steroids as those in the American Cellular products. The F.D.A. warning follows the agency’s crackdown on more than 70 brands of weight-loss supplements that the agency found to illegally contain hidden and potentially dangerous active pharmaceutical ingredients.

But the federal regulations governing dietary supplements are inadequate to protect consumer health, according to some experts who have studied the safety of such products.

Unlike drug makers, which must demonstrate that a drug is safe and effective before the agency approves it for sale to the public, dietary supplements are a largely self-regulating industry. Manufacturers of such products are themselves responsible for the safety and effectiveness and marketing claims of their products, and for voluntarily recalling them if problems arise. The F.D.A. has authority to act only after it has received reports of serious health problems associated with products already on sale and it is able to prove a serious health hazard. If a company refuses to voluntarily recall problem products, the agency can then file an injunction and seize the products.

Such a reactive strategy puts consumers at risk, critics said.

Posted: 7/29/2009 10:56:00 AM

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Pfizer Faces First Trial on Neurontin Suicide Claim

From Bloomberg.com:

Pfizer Inc., the world’s biggest drugmaker, goes to trial on claims its epilepsy medication Neurontin increases the risk of suicide, in a case the judge called “very tough” for the plaintiffs to win.

The July 27 trial will be the first of what plaintiffs’ lawyers say are about 1,200 cases. It will show each side the other’s strategy and may help point the way to settlements. The lead attorney for the family of Susan Bulger, 39, who took the drug before hanging herself in 2004, is Mark Lanier, winner of the biggest verdict over Merck & Co.’s painkiller Vioxx.

Pfizer says Bulger’s suicide was unrelated to its medicine and points to what it calls a history of mental disorders and abusing drugs including cocaine. Her past might make it hard for the family to win, said Robert Rabin, a law professor at Stanford University in Palo Alto, California.

“If she was taking other drugs, there’s a question if this particular drug contributed to the suicide,” Rabin said in a phone interview.

The company says Bulger’s life was “fraught with psycho-social stressors, including physical and mental abuse, long-term substance abuse and addiction to cocaine, heroin, Methadone and Oxycontin.”
“Mrs. Bulger attempted suicide multiple times before ever ingesting Neurontin,” Pfizer said in court papers. “Six months before her suicide, Mrs. Bulger was caught buying cocaine on the street,” it said.

Lanier, a Houston lawyer representing the family and about 600 other Neurontin plaintiffs, counters that the drug helped push a “fragile lady” over the edge. He is asking for $250,000 in compensation plus punitive damages.

Lanier also will rely on a December decision by the U.S. Food and Drug Administration to order all makers of epilepsy drugs to add a suicide-risk warning to their labels.

The agency’s reviewers found an 80 percent rise in suicidal thoughts and behavior in data from 199 studies of 11 drugs. Pfizer opposed the warning, saying Neurontin was safe and it was unfair to combine data for medicines that work differently.

The judge refused to dismiss the Bulger case and others on alleged failure to warn of Neurontin’s side effects. She rejected Pfizer’s bid to block expert testimony the drug increases the risk of suicide.

“Pfizer believes that the reliable scientific evidence does not demonstrate a causal association between Neurontin treatment and suicidal behavior,” said Loder, the spokesman.

“The Neurontin label prior to Mrs. Bulger’s death was adequate and appropriate based on the reliable scientific data concerning the medicine, and all pertinent safety information was provided to the FDA,” Loder said.

Posted: 7/28/2009 1:26:00 PM

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Wikipedia Teaches NIH Scientists Wiki Culture

From Wired Science:

The next time you read a health-related article on Wikipedia, it might have been improved through a new collaboration between the National Institutes of Health and the Wikimedia Foundation.

Ten experienced Wikipedia volunteers visited the NIH headquarters in Bethesda, Maryland, last week to train the scientists there on how to use and contribute to the world’s de facto outboard brain. It was the first “Wikipedia Academy” to take place in the United States.

“One of our goals is to increase the scientists’ understanding of Wikipedia and the established practices and procedures that have evolved over the years,” said Frank Shulenberg, who organized the academy as head of public outreach for the Wikimedia Foundation. “They need some instructions about what’s going on and why Wikipedia culture is like it is.”

While the subject experts have epigenetics and infectious-disease outbreaks down cold, they don’t really know the complex social dynamics of the site’s thousands of contributors.

Wikipedia, by virtue of its massive and open collaboration process, is often seen as the best example of crowdsourcing. Thousands of people write, edit and source the articles that 300 million people a month look to for accurate information. The academy event aims to bring more subject experts to what has become the de facto storehouse for human knowledge.

To open-government advocates, NIH’s move represents an important step toward recognizing how to reach people online.

“NIH could have gone the typical route and warned the public against using unreliable sources for information, but they get it: That’s not going to happen,” wrote Matthew Barton at the Personal Democracy Forum. “Wikipedia is going to stay popular, so it’s vital that it provides correct information.”

In science, Wikipedia’s bigger issue might not be accuracy. As our own Thomas Goetz pointed out last year, the site doesn’t always have the most accessible articles on complex topics.

Still, having more people who actually know what they are talking about contributing to the site’s articles can’t be a bad thing.

“I think the main point is that [the NIH] recognizes what a great opportunity for doing outreach Wikipedia is,” Shulenberg said. “If you contribute to Wikipedia, you reach a large audience and we all want health-related information that’s reliable.” 

Posted: 7/27/2009 4:20:00 PM

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Biggest meth victims are littlest users

From the Mankato Free Press:

Law enforcement agencies, social workers and health providers have been talking about the damages caused by methamphetamine use for a long time, but it’s the stories about the most innocent users that have caught Kate Cox’s attention.

Cox is an Immanuel St. Joseph’s Hospital employee who works with meth-using mothers and their newborn babies. Her job includes taking babies who have tested positive for methamphetamine away from their mothers before they leave the hospital.

“It’s heart-wrenching just to know these innocent, sweet peanuts have this drug in their system,” Cox said, describing the acid burns meth babies get when they discharge the drug from their bodies. “The most astounding thing for me is their mothers do not realize that what they’re doing is child abuse.”

Babies are taken from their mothers because of methamphetamine abuse on a monthly basis at the Mankato hospital, Cox said. Doctors and social workers look for obvious signs of use in mothers, such as deteriorating teeth and skin. Tests are also done during prenatal care.

Meconium, which is a baby’s first stool, can be tested for the presence of methamphetamine, too, Cox said. Those tests will show if the mother has used meth within the past three weeks.

Babies of mothers identified as users are taken away by social workers and law enforcement officers. The babies are placed in emergency foster care and aren’t returned until their mothers complete parenting assessments and pass random drug-screening tests.

Supreme Court Ruling Requires Crime Lab Analysts to Testify

Article updated in Forensic Magazine, July 24.

Not everyone agrees that this decision will cripple crime labs and compound backlogs. The Allegheny County Medical Examiner in Pennsylvania, Dr. Karl E. Williams, sees this as no more than an irritation. 

Duquesne University law professor Bruce Antkowiak concurs, believing that few defense attorneys would want to put a scientist on the witness stand.

"To a jury, the most compelling evidence is the scientific evidence," Antkowiak told the Tribune-Review. "As a defense attorney, the last thing you want is to put that nice, impressive scientist on the stand to go into great detail and show blown-up photographs of evidence that will just fascinate the jury, and it's stuff you probably aren't even contesting in the first place.”

“The decision in Melendez-Diaz v. Massachusetts will have relatively little impact on prosecutors in Michigan, which is among a minority of states that already require lab technicians to testify about any test results they produce,” Brian Dickerson wrote for the Detroit Free Press. “But it effectively precludes legislation to ease that burden on Michigan State Police scientists, who are currently logging 15 or more hours of overtime a week to process an enormous backlog of forensic evidence.”

Dickerson agreed, that the sky will not fall due to the Melendez-Diaz decision. “But the cost of putting those who manufacture, sell, and use illicit drugs behind bars rose significantly this week. And now those of us who pay the freight have even more reason to wonder if we're getting our money's worth,” he writes.

Michigan, however, may hold the key to dealing with the burden imposed by the Court’s decision. When the state passed .08 BAC legislation, law enforcement was encouraged to ask for drug and blood screening on all blood draws of suspected impaired driving offenders. This caused a dramatic spike in the caseload for blood/alcohol analysis at the Michigan State Police Forensic Science Division's Toxicology Laboratory.

Due to Michigan’s requirement for analyst testimony, lab scientists were forced to spend a significant portion of their workday traveling and testifying in courts across the state. The Michigan State Police decided to implement a video testimony program allowing analysts to testify from their own labs via video transmission. Video technology even allows analysts to schedule multiple testimonies with various courts across the state on the same day.

After multiple video testimonies utilized by courts across the state, overall savings are estimated at approximately $1,100 per testimony. This technology has also saved the state many staff hours (typically wasted in travel time), utilizing the technology to reduce the time scientists are out of the lab to 30 minutes instead of 14 hours, the Michigan Office of Highway Safety Planning reports.

After one full year of operation, the State Police Forensic Science Laboratory experienced a decreased alcohol backlog of approximately 150 - 200 cases from a high of 300 cases, with a turnaround time of approximately 5 days, from a high of 14 days. The toxicology (drug) backlog decreased to approximately 600 cases from a high of 1,000 cases with a turnaround time of 60 days, from a high of 120 days.

Virginia, too, might have a solution in the form of a state Supreme Court decision allowing the prosecution to give the defense notice before the trial if they intend to use a lab report. This gives the defense a chance to request the analyst’s testimony prior to the trial. The U.S. Supreme Court will be hearing a case in their next term to determine whether this ruling is consistent with the requirements of Melendez-Diaz.

Depending on how states choose to interpret the Court’s decision. Creative solutions like those in Michigan and Virginia could mitigate the burden on crime labs.

***************************

From Forensic Magazine:

A U.S. Supreme Court ruling last Thursday will require crime lab analysts to appear in court and submit to cross-examination if their reports are entered into evidence. This ruling could have tremendous impacts on how crime labs operate and exacerbate the backlog problems that plague crime labs nationwide.

The contentious 5-4 ruling in Melendez-Diaz v. Massachusetts asserts that forensic analysts must testify under the Sixth Amendment Confrontation Clause granting defendants the right to confront witnesses against them. Previously analysts could be subpoenaed to court to explain their reports or methodology, but it was a rare practice.

In his decision, Justice Antonin Scalia called into question the reliability of forensic science as a whole, citing the recent National Academy of Science report. Refuting the argument that forensic reports, as scientific findings, are neutral facts rather than accusatory testimony, Justice Scalia wrote, “Forensic evidence is not uniquely immune from the risk of manipulation. According to a recent study conducted under the auspices of the National Academy of Sciences. … Confrontation is designed to weed out not only the fraudulent analyst, but the incompetent one as well. Serious deficiencies have been found in the forensic evidence used in criminal trials.”

“Like expert witnesses generally, an analyst’s lack of proper training or deficiency in judgment may be disclosed in cross-examination,” Scalia adds.

In his dissenting opinion, Justice Anthony M. Kennedy strongly opposes this interpretation of the Confrontation Clause claiming that the Court is haphazardly sweeping away a century of precedent for dealing with scientific evidence.

The Court leaves it to individual states to establish a procedure for contesting lab reports and calling analysts to court, so it is difficult to tell what the full consequences of this decision will be and how it will be interpreted.

“The Court dictates to the States, as a matter of constitutional law, an as-yet-undefined set of rules governing what kinds of evidence may be admitted without in-court testimony. Indeed, under today’s opinion the States bear an even more onerous burden than they did before,” Justice Kennedy protests.

“There is no accepted definition of analyst, and there is no established precedent to define that term,” Justice Kennedy adds. “Consider how many people play a role in a routine test for the presence of illegal drugs. It is not at all evident which of these persons is the analyst to be confronted under the rule the Court announces today.”

Dean Gialamas, ASCLD President, says that though it is hard to know how Thursday’s ruling will be interpreted, “It will have an impact on crime labs, and it will be felt.”

Justice Kennedy fears that, “By requiring analysts also to appear in the far greater number of cases where defendants do not dispute the analyst’s result, the Court imposes enormous costs on the administration of justice.”

In the current fiscal climate with budget and personnel cuts, this decision could not have come at a worse time.

“[This ruling] will have a doubly detrimental effect,” Gialamas says. “Crime labs are losing positions and those existing will have an increased work load.” You can’t just hire people, Gialamas adds. “It would take 12 to 24 months to hire and train a new analyst, even if money were available.”

Justice Kennedy cites the sheer number of cases that an analyst works on each year. Even considering that 95% of cases end in plea bargain, he estimates that Philadelphia’s 18 drug analysts will be required to testify in more than 69 trials next year and Cleveland’s 6 drug analysts (two of whom work only part time) must testify in 117. Not to mention the 500 analysts at the FBI’s lab in Quantico who conduct over a million tests a year.

“The Court’s decision means that before any of those million tests reaches a jury, at least one of the laboratory’s analysts must board a plane, find his or her way to an unfamiliar courthouse, and sit there waiting to read aloud notes made months ago,” Justice Kennedy writes.

Justice Scalia dismisses these financial and logistical concerns in his ruling. “The Confrontation Clause may make the prosecution of criminals more burdensome, but that is equally true of the right to trial by jury and the privilege against self-incrimination. The Confrontation Clause—like those other constitutional provisions—is binding, and we may not disregard it at our convenience.”

Posted: 7/24/2009 2:00:00 PM

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Results of the 2007 National Roadside Survey of Alcohol and Drug Use by Drivers

From the National Highway Traffic Safety Administration (pdf file):

Over the last four decades, the National Highway Traffic Safety Administration (NHTSA) and/or the Insurance Institute for Highway Safety have conducted four national surveys to estimate the prevalence of drinking and driving in the U.S. These surveys utilized a stratified random sample of weekend nighttime drivers in the contiguous 48 States. The first National Roadside Survey (NRS) was conducted in 1973, followed by national surveys of alcohol use by drivers in 1986, 1996, and 2007.

The 2007 NRS included, for the first time, measures to estimate the use of other potentially impairing drugs by drivers. Prior roadside surveys had collected breath samples to determine blood alcohol concentration (BAC). Due to developments in analytic toxicology, NHTSA determined it would be feasible in the 2007 survey to collect oral fluid and/or blood samples to determine driver use of a wide variety of other potentially impairing drugs.

The 2007 NRS was designed to produce national estimates of alcohol and drug use by drivers. Thus, the use rates shown below are national prevalence rates calculated from the percentage of subjects using alcohol or drugs and adjusted with an appropriate weighting scheme.

Results of the 2007 Survey: Alcohol

The 2007 NRS found a dramatic decline (71%) in the number of drinking drivers with BACs at or above the current legal limit of 0.08 g/dL* on weekend nights compared to previous surveys. Similar declines were found at other BAC levels. For example, the percentage of drinking drivers (any positive BAC) declined almost as much over this time period, but one cannot infer impairment at very low BACs.

The percentage of male drivers with a BAC over the current legal limit of 0.08 g/dL was 42% higher than the percentage of female drivers with illegal BACs. Over 2% of the weekend nighttime drivers had illegal BACs (>0.08g/dL) while only 0.1% of daytime drivers had illegal BACs.

Time of day made a big difference in the likelihood of drivers having illegal BACs. Looking just at Friday daytime (9:30 a.m. to 11:30 a.m. and 1:30 p.m. to 3:30 p.m.), early nighttime (10:00 p.m. to midnight), and late nighttime (1 a.m. to 3 a.m. Saturday), only 0.2% of drivers had illegal BACs during the daytime, while 1.2% had illegal BACs during the early nighttime and 4.8% had illegal BACs during the late nighttime.

Substantial differences were observed in the percentage of drivers with illegal BACs by vehicle type. Motorcycle riders were more than twice as likely as passenger car drivers to have had BACs > 0.08 g/dL (5.6% compared to 2.3%). Pickup truck drivers were the next most likely vehicle type to have illegal BACs (3.3%).

Underage drivers are of special interest since they have been shown to be a high risk of crash involvement when drinking and driving. The percentage of underage drivers in fatal crashes with a 0.08 g/dL or higher BAC decreased from 1973 to 1996. However, from 1996 to 2007, there has been a slight increase. The NRS data do not show this same trend; the percentage of underage drivers with 0.08 g/dL or higher BACs has been decreasing throughout this time period.

Results of the 2007 Survey: Drugs

Participants in the 2007 NRS were asked to provide an oral fluid and blood sample in addition to a breath sample. The oral fluid and blood samples were tested for the presence of a large number of potentially impairing drugs. The list of impairing drugs covered illegal, prescription, and over-the-counter products, including stimulants, sedatives, antidepressants, marijuana, and narcotic analgesics.

Based on the oral fluid results, more nighttime drivers (14.4%) were drug-positive then were daytime drivers (11.0%). Based on the blood test results which were administered only at nighttime, 13.8% of the drivers were drug-positive. Using the combined results of either or both oral fluid and blood tests, 16.3% of the nighttime drivers were drug-positive.

The most commonly detected drugs were Marijuana (THC) at 8.6%, Cocaine at 3.9%, and Methamphetamine at 1.3% of nighttime drivers.

The full significance of these findings for highway safety will only become clear when ongoing and additional research conducted by NHTSA and others is completed. NHTSA is responding to these findings with programs to enable law enforcement officers to recognize drug impairment, and education for prosecutors and judges on factors associated with drug-impaired driving cases.

Under the Drug Evaluation and Classification program, NHTSA has prepared nearly 1,000 instructors and trained more than 6,000 officers in 46 states. Officers receive extensive training to recognize symptoms of driver impairment by drugs other than alcohol.

NHTSA has also initiated a follow-on study to the 2007 NRS to identify which drugs are associated with higher crash risk. This case-control study will include in-depth investigations of a large number of crashes of all severities. The proportion of drug use by crash-involved drivers will be compared to that of a similar sample of non-crash involved drivers to determine if drug use is associated with crash involvement. Findings from this large-scale study are expected in 2012.

Posted: 7/22/2009 9:57:00 AM

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Toxicology Processing Times: Even Michael Jackson Has to Wait

From Forensic Magazine:

With several high profile cases in the news, the focus has turned on increased toxicology processing delays. Michael Jackson’s and other high profile cases might get to cut in line, but the tests still take time—especially when the tests involve multiple substances.

Labs around the country are getting pressure to reduce their toxicology backlogs, but you can’t rush the process. While toxicology results can reveal critical clues about cause of death they can take months to complete, even if the dead received pop-icon status in life.

“Fluid specimens change hands at least three or four times, as different investigators with different pieces of lab equipment conduct different types of tests,” Medical Examiner Dr. Karl E. Williams told the Pittsburg Post-Gazette. “Results must be interpreted and considered in the context of a person's medical history.”

Investigations are especially difficult if multiple drugs are detected, in which case toxicologists must determine the levels of each drug present in the body and whether they could have combined in a detrimental way.

At any given time a toxicology lab will have hundreds of tests in various stages, but the tests take time and most labs are experiencing backlogs. High profile cases, like Michel Jackson’s are usually bumped to the front of the line, and cases can get a rush if they involve a live subject or are going to court, but even Jackson’s results took weeks. To make matters worse, toxicologists are called out of the lab to testify in court, making the backlogs grow.

California conducted a study several years ago on toxicology processing times in the Orange County Lab trying to determine ways to reduce processing time from eight to four weeks and determined that more research was needed to resolve the problem.

In Michigan, they have addressed the backlog by launching the Video Testimony Pilot Project. This has reduced the time lost testifying in court by allowing analysts to testify remotely through streaming video.

After a full year of operation, the State Police Forensic Science Laboratory reports that the alcohol backlog decreased to approximately 150–200 cases from a high of 300 cases, with the turnaround time reduced to 5 days, from a high of 14 days. The toxicology (drug) backlog decreased to approximately 600 cases from a high of 1,000 cases, with the turnaround time was at 60 days, from a high of 120 days.

Like most forensic laboratories, toxicology labs are facing budget, personnel, and resource cuts and yet, with an increased reliance on technology, victims, juries, and the public demand that more tests be run. And if you’re Michael Jackson, you’d better run them twice.

Posted: 7/20/2009 12:51:00 PM

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FDA Takes Action on Darvon and Other Pain Medications

From the FDA:

On July 7, 2009, the Food and Drug Administration (FDA) announced actions it was taking to reduce the risk of overdose in people who use pain medications, such as Darvon and Darvocet. These medications contain the drug propoxyphene, which is linked to death from overdoses.

FDA finds there is evidence that propoxyphene can effectively treat pain at recommended doses. But because of the drug’s potential risks, the agency is requiring manufacturers to provide more information to help physicians and patients decide whether propoxyphene is the appropriate pain treatment.

FDA Actions
  • FDA is requiring manufacturers of propoxyphene-containing products to strengthen the label’s boxed warning to emphasize the risk for overdose when using these products.
  • FDA is requiring manufacturers to provide a medication guide (FDA-approved information that must be given to patients with each prescription or refill) to stress the importance of using the pain drugs only as directed.
  • FDA is requiring a new safety study to find out more about the effects of propoxyphene on the heart at higher than recommended doses.
  • FDA is planning to work with other federal agencies, such as the Centers for Medicare and Medicaid Services and the Department of Veterans Affairs, to conduct additional studies on the safety of products that contain propoxyphene as compared to other commonly used pain medications.
  • FDA has denied a citizen petition from the public interest group Public Citizen requesting a phased withdrawal of propoxyphene.
  • FDA will further evaluate the safety of propoxyphene and take additional regulatory action, if necessary.
Advice for Consumers
  • Be aware of all the risks associated with pain medication, including propoxyphene, when making decisions on how to treat pain. All pain medicines have side effects.
  • Talk to your health care professional to decide on the appropriate pain treatment for you if you need relief from pain.  
Posted: 7/16/2009 4:50:00 PM

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Drunken driving is down. But what about drug use by drivers?

***Update***

Press Release on the NHTSA Roadside Survey of Alcohol and Drug Use.

------------------------------------------------

From The Christian Science Monitor:

Americans seem to have finally gotten the message: It's not OK to drive while drunk. But driving on drugs appears to be another matter and a significant problem.

The National Highway Traffic Safety Agency (NHTSA) on Monday released the results of its 2007 Roadside Survey of Alcohol and Drug Use. It found that the share of Americans driving while intoxicated on weekend nights is at a low of 2.2 percent. That's down 71 percent from the mid-1970s, when the survey was first conducted. Back then, 7.5 percent of the drivers surveyed had blood alcohol-content levels higher than the legal limit.

That's the good news. But for the first time, the survey also looked at drug use late on weekend nights. It found that 16.3 percent of drivers had traces of drugs in their system, including marijuana, cocaine, and various stimulants, sedatives, antidepressants, and narcotics. But the survey's authors cautioned that it was difficult to tell from the findings whether the drivers were impaired, because traces of some drugs like marijuana can be found weeks after a chronic user has stopped taking the drug.

For years, law-enforcement officials have encountered drivers who seemed to be impaired but did not test positive for alcohol. That prompted the NHTSA to start research on how drugs can affect an individual's ability to drive safely. One issue still to be resolved is how to test for, and find a safe driving threshold for, drugs that can stay in a person's system for days or even weeks.

"We know what that threshold is for alcohol, and states have universally set 0.08 blood alcohol content as the limit," Mr. Tyson says. "We still have a lot of research to do and a lot to learn in terms of what impact drugs have on your system and at what point a driver is too impaired by drugs to be behind the wheel."

For groups like Mothers Against Drunk Driving (MADD), which has been working to get intoxicated drivers off the roads and to educate young people since 1980, the survey results on drunken driving are encouraging.

Mr. Griffin says that MADD does have "major concerns" about the number of people driving under the influence of drugs, but the group will keep its focus on drunken driving.

Posted: 7/16/2009 2:22:00 PM

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Limited recall of drug central to Jackson probe

From The Associated Press:

LOS ANGELES (AP) — A maker of the potent anesthetic propofol found in Michael Jackson's home has been contacted by federal officials investigating the pop star's death and has recalled tens of thousands of vials of the drug after two tainted lots sickened dozens of patients.

There is no apparent connection between the bacterial contamination that prompted the recall and Jackson's death. Teva Pharmaceuticals spokeswoman Denise Bradley told The Associated Press on Tuesday.

Propofol usually is administered intravenously in hospitals to patients who need to be unconscious for surgery or other procedures.
Teva announced it was recalling two lots of propofol — 57,620 vials in all — after concluding bacterial contamination caused up to 40 patients in Florida, Arizona and Missouri to develop fevers and chills since May. Investigators believe vials were distributed nationally and are urging doctors not to use any propofol from the two lots.

FDA investigators arrived Monday at the Teva plant in Irvine, Calif., where the suspect lots were made and were looking for any irregularities in the manufacturing process, Riley said.

Investigators believe that bacteria in vials of the anesthetic released toxins into the drug which caused the fever, Srinivasan said.

Posted: 7/16/2009 12:00:00 PM

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