Archive for November, 2009

CDC Panel: Sex-Ed Programs Work

November 30th, 2009 | No Comments | Source: Washington Post

Comprehensive, school-based sex-education programs that teach teens about contraception and encourage them to delay sexual activity increase condom use and lower the risk of contracting sexually transmitted diseases including HIV, according to a panel appointed by the CDC.

thatcouldbeme 300x199 CDC Panel: Sex Ed Programs WorkBut the panel concluded there isn’t enough evidence to endorse programs focused more narrowly on encouraging sexual abstinence until marriage.

The 15-member Task Force on Community Preventive Services reached these conclusions after reviewing 83 studies of such programs that were run between 1980 and 2007.

“Evidence and common sense have returned to public-health policy,” James Wagoner of Advocates for Youth told the Washington Post. “The report endorses a comprehensive approach to prevention that includes condoms and birth control. We should be spending taxpayer dollars only on evidence-based programs.”

Alas, 2 panelists, Irene Erickson of the Institute for Research and Evaluation and Danielle Ruedt of the Georgia Governor’s Office of Children and Families disputed these conclusions.

According to them, “the data indicated that many types of [comprehensive] programs do not work. Unfortunately, the report’s conclusion ignores these findings. This is misleading to policymakers who are seeking evidence-based programs, especially for schools.”

Answering these claims, panelist Randy Elder, who also works for the CDC, argued that the critics’ case was incorrect.

“Those points…reflect a misunderstanding of a systematic review process,” he said. “The whole point of what we are doing is to aggregate data from many studies that are critical to answering the question. What they were doing was chopping up the evidence into fine subsets to poke holes.”

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NHLBI Halts CPR Trial

November 27th, 2009 | No Comments | Source: Elsevier Global Med News

The National Heart, Lung, and Blood Institute has shut down a trial designed to compare cardiac arrest resuscitation strategies used by emergency medical technicians after an analysis of preliminary data revealed the newer strategies were ineffective.

newheartcells 300x199 NHLBI Halts CPR TrialThe obliquely named study, “Resuscitation Outcomes Consortium Prehospital Resuscitation using an Impedance valve and Early versus Delayed” looked at a pair of new strategies.

The first one involved using an impedance threshold device to improve circulation during CPR, supposedly by enhancing changes in chest pressure.  The device featured a valve attached to breathing tubes that are normally inserted by EMTs during the course of CPR. It didn’t work.

The second part of the trial was designed to assess whether different CPR protocols had an impact on survival. In the so-called early protocol, EMTs performed CPR until they could analyze the victim’s heart rhythm (usually 30-90 seconds).

In the late protocol, techs performed CPR for at least 3 minutes before assessing the victim’s heart rhythm. Defibrillation was used when indicated. Neither strategy proved superior to the other.

After reviewing data from 11,500 cases, the trial’s Data and Safety Monitoring Board determined that continued enrollment of new patients was not going to change the disappointing results. Soon thereafter, the NHLBI turned out the lights.

The researchers agreed to continue monitoring survivors for up to 6 months. A final report is due out next spring.

“We will continue to search for new ways to save lives in the precious few moments after cardiac arrest – and evaluate the benefits and risks of commonly used practices,” Susan Shurin, deputy director of the NHLBI, said resolutely.

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Novartis to Establish R&D Shop in China

November 25th, 2009 | No Comments | Source: Wall Street Journal

Swiss pharmaceutical giant Novartis announced last week that it will invest $1 billion into an R&D facility in Shanghai, China.

theworldaccordingtoChina 300x299 Novartis to Establish R&D Shop in ChinaChina’s remarkable economic growth is driving the decision, according to Chief Executive Daniel Vasella.

Company strategists predict China could vault into the top 3 national markets for the company’s products as soon as 2014.

The prediction is based on Novartis’ astounding 30% growth in revenues from China in each of the last several years.

That trend is likely to accelerate now that Chinese officials have decided to overhaul the nation’s health care system, most notably by rebuilding moribund facilities in rural areas and expanding health insurance to 90% of China’s citizens by 2011.

Novartis’ investment will be spread over 5 years. It will boost the headcount in the company’s Shanghai R&D facility from 160 to 1,000, making it more or less equal in size to the company’s A-number one research shop in Cambridge, Massachusetts. The  company’s HQ in Basel remains the largest facility overall.

“I think it will be a signal of China’s rising importance in the pharmaceutical industry,” Vasella told the Wall Street Journal during a recent sojourn to Beijing. “You have to ask yourself, where do you need to be down the road, and clearly it is here.”

Vasella added that his decision was made possible because of the newfound plethora of scientific talent in China. He brushed off concerns about the country’s notoriously lax protections of intellectual property.

Novartis’ move into China is at least the third by a large pharmaceutical company in recent years. Roche opened a research lab there in 2004, and a clinical trial center in 2007.  In 2006, AZ opened a research center in Shanghai. It is building another one in Zhangjiang.

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Antibiotic Misuse Costs $20b Per Year

November 24th, 2009 | No Comments | Source: Clinical Infectious Diseases

Inappropriate use of antibiotics and consequent antibiotic-resistant infections waste $20 billion per year, according to a study published in Clinical Infectious Diseases.

heregocurecancer 300x200 Antibiotic Misuse Costs $20b Per YearTo reach this conclusion, Rebecca Roberts and colleagues at Cook County (Stroger) Hospital quantified antibiotic resistant infections (ARIs), total costs, length of stay, length of ICU stay, surgeries and mortality rates for 1,391 high-risk adult patients that were hospitalized in the year 2000. 

The scientists found that 188 (13.5%) patients developed an ARI. The medical costs attributable to ARIs ranged from $18,588 to $29,069 per patient. In these patients, length of stay was 6.4–12.7 days longer than in those who did not develop ARIs. Excess mortality in the ARI group was 6.5%.

Common ARIs include methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), as well as many other bacteria that are becoming resistant to common antibiotics.

“Significant health and economic benefits could be realized through effective interventions to reduce antimicrobial-resistant and healthcare-associated infections,” said Roberts in a press release.

Stuart Levy, a senior author on the paper added that his study “demonstrates the enormous cost savings that could be realized for both the health care system and to individuals and their families…these costs will continue to increase if we don’t practice a more prudent usage of antibiotics.”

Levy added that more studies are needed to determine how much could be saved at a national level if we took steps to slow the rise of resistant infections, especially those acquired in hospital settings.

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Compulsive Hoarding

November 23rd, 2009 | No Comments | Source: Wall Street Journal

Most of us tend to accumulate stuff of one sort or another, and many of our closets and drawers are hopelessly cluttered. But that’s not the same thing as compulsive hoarding, a psychological affliction that some experts estimate affects nearly 2% of the population.

CompulsiveHoarding 300x200 Compulsive HoardingThe homes of compulsive hoarders are stuffed with rotten food and sundry what-have-yous that bury sofas, beds, bathtubs and sinks and block doors and hallways.

Their possessions are disorganized, their bills are frequently unpaid (in part because they are lost in the pile) and their household utilities frequently are cut off as a result…an outcome that exacerbates the squalor.

You may even know a hoarder. “Attorneys, surgeons, business executives—some very bright and successful people have this problem,” according to San Francisco psychologist Michael Tompkins, who has written a book on the subject.

In some hoarders, the behavior is thought to be a manifestation of obsessive-compulsive disorder. In others, the underlying condition appears to be dementia, ADD, PTSD or depression. In still others, the loss of a family member or a job triggers the behavior.

Some hoarders focus their attention on household pets, and cases have been reporting involving 1,000 or more in one home. The hoarders don’t notice the animals are filthy or malnourished, and believe they’re saving the critters from something worse.

What can be done to help such people? Experts say it can be profoundly harmful to forcibly clean up the mess. Hoarders perceive this to be a violation and are bound to repeat the behavior. Better to rely on patience and understanding. 

Professional organizers can help, as can antidepressants and behavioral therapy, but all of these are hit-or-miss at best.

As a last resort, Tompkins recommends “harm reduction” strategies: accept that the behavior will continue and minimize the danger it presents by keeping stairways and doors clear and moving flammable objects from space heaters and stoves.

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IBM Drops Co-Pays for PCP Visits

November 20th, 2009 | No Comments | Source: Wall Street Journal

IBM, one of largest employers in the nation, has decided to waive the $20 co-payments it had charged company-insured employees for visits to their primary care physicians.

Big Blue believes the move can cut its health costs by encouraging people to see their PCPs more frequently which should result in earlier diagnoses and reductions in the number of visits to specialists and ERs.

IBM IBM Drops Co Pays for PCP VisitsRandy MacDonald, IBM’s Sr. VP for Human Resources, said the move “is designed to encourage people to get fixed early…we’d rather diagnose a situation and deal with it quickly as opposed to it becoming chronic.”

IBM’s newfound emphasis on primary care is, according to MacDonald, part of its “wellness” strategy which reduces health care costs by preventing illness, or at least treating it earlier. IBM spent $79 million on these programs between 2004 and 2007 and estimates this approach saved the company $191 million.

IBM’s wellness programs pay employees up to $300 per year to take exercise classes or enroll their children in weight-monitoring programs. Soon, it will add a stress relief program to the mix.

“In these economic times, with the loss of home equity and the loss of savings, we are seeing stress-related issues” in employees, MacDonald told the Wall Street Journal.

Helen Darling, president of National Business Group on Health, called IBM’s move “very unusual. The number of employers who cover primary-physician visits without a co-pay is minuscule,” she said.

IBM has 115,000 US employees and spends nearly $1.3 billion per year on their health care. Its benefit practices are watched closely by other employers, and it is known to be a trend-setter in this area.

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Can Statins Help Fight Seasonal Flu?

November 19th, 2009 | No Comments | Source: MedPageToday

Physicians have quipped for years that HMG CoA Reductase inhibitors—the cholesterol-busters better known as “statins,” ought to be put in the nation’s drinking water.

lipitor Can Statins Help Fight Seasonal Flu?After all, they have an excellent safety profile, profoundly beneficial effects on serum cholesterol and cardiovascular mortality, and may even work against sepsis and prostate cancer.

The quip is likely to be heard even more nowadays, because a study by Meredith VanderMeer and colleagues from the Oregon Department of Public Health has shown that patients who were hospitalized for seasonal (not H1N1) flu–and who by coincidence were taking statins–had a lower risk of dying from the infection.

VanderMeer reported her team’s findings at the annual meeting of the Infectious Diseases Society of America.

Crestor Can Statins Help Fight Seasonal Flu?In their study of 2,800 people hospitalized for flu complications, 801 patients were taking statins for high cholesterol at the time of admission. Only 17 of of them died in the hospital or within 30 days of discharge. In the remaining 1999 patients who were not taking statins, 64 died.

The difference in mortality, 2.1% vs. 3.2%, amounted to a statistically significant 54% reduction, and persisted after controlling for confounding factors such as age and the use of antiviral drugs.

Patients in the study were taking a variety of statins, including Crestor, Lescol, Lipitor, Mevacor, Pravachol, and Zocor. It was not clear whether any one of them was associated with more beneficial effects than the others.

zocor Can Statins Help Fight Seasonal Flu?The data for the study was pulled from the CDC’s Emerging Infections Program and covered the 2007-2008 influenza season (again, not H1N1).

According to VanderMeer, the link between statins and decreased seasonal flu mortality is not entirely surprising. Flu complications like pneumonia are caused by inflammation, and statins have anti-inflammatory effects.

VanderMeer suggested that a randomized controlled trial might help confirm her teams’ findings.

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Antipsychotics and Weight Gain in Kids

November 18th, 2009 | No Comments | Source: JAMA, Wall Street Journal

When the so-called “atypical antipsychotic” drugs hit the market 15 years ago, psychiatrists and PCPs began prescribing them like crazy for schizophrenia and bipolar disorder.

madeinchina 300x225 Antipsychotics and Weight Gain in KidsThey were motivated the poor side-effect profile of previously available drugs, and encouraged by relentless and occasionally unscrupulous marketing campaigns promulgated by drug makers and paid clinical spokespeople.

Last year, the drugs generated $14.6 billion in US sales alone, according to IMS Health.

Unfortunately, the newer drugs proved to be, at best, marginally more effective than their older, cheaper brethren, and have a nasty tendency to promote weight gain and diabetes, particularly in children—for whom they are rarely indicated, according to the FDA.

Now, Christolph Correll and colleagues at Feinstein Institute for Medical Research have quantified the weight gain problem, and it’s a lot.

According to their report in JAMA, atypical antipsychotic drugs caused youths between the ages of 4-19 years old to gain up to 19 pounds on average in just 11 weeks.

“The weight gain is much larger than we thought,” Correll told the Wall Street Journal. “It’s massive, and it’s the medication” that caused it, he added.

Correll’s study involved 272 youths who were seen at semi-urban, tertiary care, academic inpatient and outpatient clinics. It included the 4 top-sellers in the space: Zyprexa (Lilly), Abilify (BMS), Risperdal (J&J) and Seroquel (AZ). Participants had not taken the drugs previously.

Of the 4, Zyprexa caused the most weight gain—nearly 19 pounds—a 15% increase over baseline. The corpulence was associated with significant increases in glucose and cholesterol levels.

The other drugs caused weight gains between 10-13 pounds on average, and had variable effects on glucose and cholesterol.

The scientists encouraged physicians to be extremely careful when prescribing these drugs to youths and to check their patients’ weight and blood tests every 3 months.

The FDA will soon decide whether to approve these drugs for use in youths. Any bets how that turns out?

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JAMA Flies Solo on Disclosure

November 17th, 2009 | No Comments | Source: MedPageToday

In July, 2005, the prestigious Journal of the American Medical Association began requiring that all write-ups of research that had been funded by private sector sources must undergo separate statistical reviews before being accepted for publication.

JAMA JAMA Flies Solo on DisclosureOddly, no other first-tier journal followed suit.

Benjamin Djulbegovic of the University of South Florida decided to see whether the unilateral move impacted the types of trials published in top medical peer-reviewed journals. Lo and behold, it did!

In a presentation at last month’s Peer Review Congress, Djulbegovic showed a significant drop the number of industry-funded trials published in JAMA and a coincident increase in such trials that were published in the New England Journal of Medicine and Lancet, the 2 other top-tier journals he studied.

NEJM JAMA Flies Solo on DisclosureFollowing Djulbegovic’s presentation, JAMA editor Catherine DeAngelis told an audience of fellow journal editors, “the cynic in me says that if you’re not submitting to JAMA because you have something to hide, so be it. God bless the rest of you for taking those [studies]!”

Djulbegovic reached his conclusion by examining all issues from the 3 journals for the 3 years before, and the 3 years after JAMA enacted its policy.

He found that compared with the preceding period, JAMA published 26% fewer commercially-funded studies after the policy was enacted (63% vs. 37%).

Meanwhile NEJM and Lancet published 12% and 10% more such trials after the JAMA policy went into effect.

Lancet JAMA Flies Solo on DisclosureThe publishing rate for non-commercially funded studies was unchanged in all 3 journals.

Djulbegovic added that if industry-funded trials are simply rerouted from JAMA to another top-tier journal, then the JAMA policy wouldn’t have much impact.

That could only happen if other top-tier journals adopted similar policies.

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Furor over AIDS Vaccine Claims

November 16th, 2009 | No Comments | Source: Wall Street Journal

When Thai and US Army scientists announced last month that their experimental HIV vaccine reduced the risk of contracting the disease by 31%, it caused quite a stir. After all, every one of the 100 or so previous HIV vaccine trials over the last 20 years had failed completely.

Alas, a second analysis of the $105 million study that was released weeks after the announcement suggests the apparent, moderate benefit may have been caused by a statistical fluke.

Worse yet, it turns out that the results of the second analysis were available to the scientists when they announced their original findings.

onestepforwardtwoback 300x199 Furor over AIDS Vaccine Claims“We thought very hard about how to provide the clearest, most honest message,” said Jerome Kim, an Army scientist involved with the study. “We stand by the fact that this is a vaccine with a modest protective effect.”

Kim’s team based its initial announcement on a “modified intent to treat analysis,” which includes all volunteers that enrolled in the study, whether they received the full course of the vaccine or not. Such analyses reflect real world situations in which some people don’t show up for all shots in the vaccine sequence.

Using this analysis, the scientists determined that there was only a 3.9% chance that the observed 31% reduction in HIV among the vaccine-treated group was caused by a simple statistical fluke…in scientific parlance, this is considered to be a borderline significant result.

The second, so-called “per protocol” analysis included just the study participants that received all vaccines in the regimen at the right time.

Such analyses normally corroborate intent to treat findings, but for unknown reasons, it did just the opposite in this study. It suggested there was a 16% chance the results could have been due to chance alone—far too high to support claims that the vaccine was efficacious.

AIDSribbon Furor over AIDS Vaccine ClaimsSome AIDS activists and scientists believe the vaccine merits further study, but worry that the botched announcement might undermine support for the vaccine and HIV vaccine trials generally.

“I would have preferred to have seen both results straight up. It might spring back on (the scientists), and that would be unfortunate,” Mitchell Warren, director of the AIDS Vaccine Advocacy Coalition said.

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