Archive for July, 2010

Lightening the Load on Medical Residents

July 30th, 2010 | No Comments | Source: Wall Street Journal

Training program directors and patient advocates have voiced concerns for years that residents who toil for long shifts on-the-job could harm patients because fatigue increases the risk they will make errors of one sort or another.

A 6 year-old study by the Accreditation Council for Graduate Medical Education gave credence to their concerns by showing that the fatigued residents  caused more than half of all preventable adverse events.

thisisntmypillow 300x199 Lightening the Load on Medical ResidentsIn response, the ACGME recently proposed strict new guidelines which would, if adopted, curtail the duration of residents’ shifts and increase supervision requirements for those in charge of their care. The plan extends previous initiatives by the ACGME to limit the work hours of residents.

The new guidelines were published in the New England Journal of Medicine and are subject to a 45-day public comment period.

The fundamental components of the ACGME’s proposal are 16-hour shift limits for first-year residents and 24-hour limits for those in later years of training.  Current rules permit residents to work for as many as 30 consecutive hours.

Also included are instructions about the supervision of interns by residents, and beefed-up monitoring and enforcement of the guidelines including annual site visits of each program.

In a replay of what happened the last time ACGME addressed the subject, some physicians and patient advocacy groups said the new guidelines didn’t go far enough. These groups pointed out that the guidelines weren’t as far-reaching as the changes recommended by the Institute of Medicine in 2008.

Meanwhile, some physicians argued the new limitations would impede the educational process and result in more errors…the kind that occur during hand-offs in care at the ends of shifts. Hopefully, some well designed studies of the matter can add value to the debate once (and if) the new guidelines go into effect.

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Coffee and Cancer of the Head and Neck

July 28th, 2010 | No Comments | Source: Cancer Epi. Bio. & Prev., MSNBC

Could coffee stave off more than just fatigue? A new study suggests that might be the case. Heavy coffee drinkers, it turns out, have a lower incidence of head and neck cancers, according to the study, which was published in Cancer Epidemiology, Biomarkers & Prevention.

OSHAinspectorsatwork 300x199 Coffee and Cancer of the Head and NeckTo reach these conclusions, Mia Hashibi and colleagues pooled results from 9 previous studies which looked at coffee and tea drinking, as well as rates of head and neck cancers. In those studies, the behaviors of cancer patients were compared with either the general population or to patients that were hospitalized for reasons other than cancer.

The scientists found that people who drank coffee had a 12% lower risk of developing head and neck cancers than those who didn’t, after controlling for several factors including cigarette smoking. In addition, the scientists found an inverse correlation between the amount of coffee consumed and the risk of cancer: for people who drank at least 4 cups per day, the risk was cut by more than one third.

Head and neck cancer is relatively rare, affecting only about 1 in 10,000 people per year. It is known to be associated with alcohol intake and cigarette smoking.

Hashibi’s group noted that the association doesn’t prove that coffee protects against cancer of the head and neck. Other factors associated with coffee drinking could be driving the association. Alternatively, people with the disease might have reduced their coffee consumption for some reason.

There are several mechanisms by which coffee might be protective, although they are all speculative at this point.

“Coffee contains more than a thousand chemicals,” wrote the authors, including compounds like cafestol and kahweol which are thought to protect DNA from the damaging effects of certain carcinogens.

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FDA Panel Gives Avandia a Reprieve

July 27th, 2010 | 1 Comment | Source: Wall Street Journal

An FDA advisory panel has voted to allow ongoing sales of the diabetes drug Avandia, even though it expressed concern that Glaxo’s former blockbuster increases the risk of cardiovascular events like heart attacks.

easiertoloseweight 300x199 FDA Panel Gives Avandia a ReprieveThe FDA is not required to follow the recommendations of its panels, although it usually does.

Nearly one-third of the 33-member panel voted to ban Avandia. Most panelists who voted to keep the drug on the market called for increased restrictions on its use, saying it should be used only as a second- or third-line drug for the treatment of diabetes.

For example, David Oakes, a statistics professor at the University of Rochester, told the Wall Street Journal that his vote for continued sales of Avandia should not be construed a “vote of confidence,” but rather as reflecting his concerns about the quality of studies which link Avandia to heart attacks.

Janet Woodcock, who heads-up the FDA’s drug division, said her agency will decide on the matter within the next few weeks.

Avandia sales have plummeted since a 2007 article in the New England Journal of Medicine reported a 43% bump in heart attack risk with Avandia. Q1, 2010 world-wide sales of Avandia are reported to have been $245 million, off 10% year-over-year.

The FDA panel also concluded that Avandia posed a greater heart attack risk than Actos, a rival drug made by Takeda. Both drugs were approved in 1999 for blood-glucose control in patients with Type 2 diabetes.

In the wake of the panel’s announcement, Glaxo’s Chief Medical Officer Ellen Strahlman defended the safety record of Avandia. She said the drug would remain on the market pending the FDA’s decision.

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Fight among Anthrax Vaccine Makers

July 26th, 2010 | No Comments | Source: Wall Street Journal, Washington Post

Almost 9 years after letters laced with weapons-grade anthrax spores killed 5 people and inflamed fears about bioterrorism, the US still relies on a single anthrax vaccine maker that uses expensive, impractical, decades-old technology.

newNYCfashion 300x199 Fight among Anthrax Vaccine MakersThe company is Emergent BioSolutions, and its BioThrax vaccine is its only product. Emergent has copped $1.4 billion in federal contracts for the vaccine in the last decade alone.

Twice before, the Feds tried to find cheaper anthrax vaccines and increase the number of vaccine suppliers. In 2004, it awarded an $877 million contract to VaxGen, but aggressive lobbying by Emergent and manufacturing problems at VaxGen forced the Feds to void that contract.

A second RFP that was released last year by Barda–the Biomedical Advanced Research and Development Authority–was halted after officials determined that no supplier could produce a vaccine quickly enough.

That was a setback for PharmAthene, a rival to Emergent. PharmAthene claims that heavy lobbying by Emergent scuttled what it thought was a sure win. Emergent spent $4 million in lobbying during 2009 to maintain its monopoly.

BioThrax requires the administration of 5 doses over 18 months, and costs the Feds $120 per person immunized. PharmAthene’s SparVax would cost $45 per person. That vaccine remains in testing, however. In fact, PharmAthene has no products on the market right now.

Barda is also hoping to lure some large consortiums into the field, including one involving Merck, GE and and the University of Pittsburgh, but they remain leery of the risks.

“The country needs an anthrax vaccine that requires fewer injections, produces fewer side effects and is made using modern techniques,” said former Sen. Bob Graham, who co-chaired a federal commission that questioned the nation’s bioterror readiness earlier this year.

UPDATE: At the time this post is being scheduled for publication, the Washington Post is reporting that Emergent BioSolutions will soon announce that it “received a contract worth up to $107 million to ready its anthrax vaccine for large-scale manufacture.

According to Emergent, the contract will pay for the company to develop and obtain regulatory approval for large-scale manufacture of BioThrax.

The award is based on an Emergent proposal that says the company can produce 26 million doses annually, a significant increase from the roughly 7 million to 9 million it generates today.”

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College Students Lack Empathy

July 23rd, 2010 | No Comments | Source: NY Times

Americans have long sensed a decline in the kindness and helpfulness of their peers. The results of a recent study suggest college students are among the worst offenders in this regard.

plavixnonresponder 300x217 College Students Lack EmpathyThe study was authored by Sara Konrath and presented at last month’s meeting of the Association for Psychological Science. Konrath’s work is titled, “Changes in Dispositional Empathy in American College Students Over Time: A Meta-Analysis.” It showed that today’s college students are 40% less empathetic than their predecessors from 30 years ago. Most of the decline appeared after 2000.

Konrath’s survey divided empathy into 4 dimensions: Empathic concern, or sympathy for the misfortunes of others; perspective concern, or the capacity to imagine other people’s points of view; the tendency to identify with fictitious characters in movies or books; and anguish felt when observing others’ misfortunes.

Modern college students scored 48% lower in empathic concern and 34% lower in perspective taking than their predecessors. In particular, they were found to be less likely to agree with statements like “I often have tender, concerned feelings for people less fortunate than me,” and “I sometimes try to understand my friends better by imagining how things look from their perspective.”

These results are notable since people are known to state agreement with shared social ideals like these more frequently than they actually do.

Previous studies have linked low empathy to violence, criminal behavior, aggression when drunk, sexual offenses and other antisocial behaviors.

What caused the change? “We don’t actually know…at this point,” Konrath told the New York Times. But she speculated that a combination of social media, reality TV, video games and intense competition have caused young people to become more shallow, self-involved, individualistic and overly ambitious.

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How Dead is the Gulf of Mexico?

July 22nd, 2010 | No Comments | Source: Uncategorized

In the 3 months since the Deepwater Horizon blew up and oil began spilling into the Gulf of Mexico, scientists have been trying to understand the magnitude of the gusher’s ecological impact.

neardeathexperienceforVCs1 300x199 How Dead is the Gulf of Mexico?So far, there is no consensus on the matter. Some believe the gulf has largely avoided an ecological disaster. Others say that the spill has pushed already damaged ecosystems to the brink.

Take those ghastly pictures of oiled birds, for example. Officials say they’ve found only 1,200 of them, a fraction of the 35,000 that were discovered after the Exxon Valdez disaster. Of course, officials only count the birds they find. Some scientists believe the number is much higher.

“It’s an instinctive response: They’re hiding from predators while they recover,” Kerry St. Pé, told the Washington Post. Pe, who oversees a marsh protection program, added “They plan to recover, and they don’t. They just die.”

What about coastal marshes, whose oil-stained shores make regular appearances on the evening news? “The marsh grasses, the canes, the mangrove are dying,” Robert Barham, secretary of the state’s Department of Wildlife and Fisheries told the Post. “There’s visible evidence that the ecosystem is changed.”

But the National Audubon Society’s Paul Kemp disagreed. According to him, the impact of the spill was small by comparison to the marsh’s existing problems.

“We have a patient that’s dying of cancer, and now they have a sunburn, too,” Kemp said. “What will kill coastal Louisiana is not this oil spill.” (It’s) what was killing it before this oil spill,” he explained, citing erosion and river-control projects.

There is also disagreement about the presence of “plumes” of dissolved or submerged oil offshore. Some scientists claim to have found underwater oil many miles from the gusher.  But an official at the National Oceanic and Atmospheric Administration said his agency found significant submerged oil only within 6 miles of the well.

“Right now,” John Valentine, a gulf researcher told the Post, “we should be more impressed by what we don’t know than what we do know.”

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Genes Predict Longevity

July 20th, 2010 | No Comments | Source: NY Times, Science

Boston University scientists claim to have identified a small set of genetic variants that accurately predicts extreme longevity in humans.

thyroidgenesahead1mile 300x225 Genes Predict LongevityThe scientists, Paola Sebastiani and Thomas Perls, examined the DNA of 1,055 centenarians living in New England. They isolated 150 gene variants that were common in this population. They subsequently examined a separate sample of centenarians and found that 77% of them had many of the same genetic variants.

The centenarians in the original cohort had as many disease-associated gene variants as shorter-lived people, so the scientists reasoned that the genes they had identified must protect against disease.

This conclusion is at odds with current thinking about extreme longevity which is predicated on the assumption that long life is caused by the absence of disease-causing gene variants, rather than the presence of protective genes.

To find the protective genes, the scientists implemented a genome-wide association study, a technique that had previously failed to meet expectations that it could unlock genetic secrets behind common conditions like diabetes and Alzheimer’s disease.

Some scientists questioned the findings of the BU group. Kari Stefansson, a geneticist who works for Decode Gentics, told the New York Times for example that he was “amazed at how many loci of genome-wide significance have been found in a modest sample size.”

Stefansson’s company has also studied extreme longevity. Apparently, none of the BU group’s 150 genetic variants showed up in the population studied by Decode Genetics.

There are roughly 80,000 centenarians in the US right now. Roughly 15 % of the general population has some or many of the 150 genetic variants found in the BU study. Most of them fail to reach extreme old age because of accidents or an unhealthy lifestyle.

The report appears in Science.

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NIH Rejects New Stem Cell Lines

July 19th, 2010 | No Comments | Source: Washington Post

The NIH has rejected a request to approve several dozen colonies of human embryonic stem cells for use by federally funded researchers. The lines were created by Reproductive Genetics Institute, a private infertility clinic based in Chicago. They contain mutations thought to be linked to several diseases including cystic fibrosis, muscular dystrophy and Huntington’s disease.

greenbaypackerstemcells 300x228 NIH Rejects New Stem Cell LinesMany scientists believe that studies using these lines will reveal new information about the diseases, and perhaps lead to new treatments, but NIH Director Francis Collins nixed the proposal on grounds that the acquisition of the new lines violated his organization’s strict ethical guidelines.

The new stem cell lines were obtained from embryos donated by couples that were receiving treatment for infertility. The company decided against using them after tests revealed the genetic defects.

An NIH advisory panel tasked by Collins to evaluate the situation found however, that the consent forms used by RGI to secure the lines included unacceptably broad language and required couples to give up their right to sue the clinic for any cause.

Collins’ decision will limit research on the valuable cell lines to scientists who have secured private funding. The new NIH director did approve 8 other new stem cell lines, meaning that federally funded scientists have 75 different lines they can use for research.

“The NIH guidelines for reviewing stem cell lines for federal funding were set up to adhere rigorously to the well-established norms for informed consent,” Collins said in a statement. “It was painful for my advisory committee to recommend against approval of additional lines from RGI because of a consent problem, but rigorous guidelines are only meaningful if they are rigorously applied.”

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Harvard Medical School Hits Up Affiliated Hospitals

July 16th, 2010 | 1 Comment | Source: Boston Globe

To help offset a drop in Harvard University’s enormous endowment, Harvard Medical School has cut a deal with its affiliated teaching hospitals that calls for the hospitals to contribute $36 million to the school over the next 3 years.

allinfavorsayaye 300x199 Harvard Medical School Hits Up Affiliated HospitalsThe figure represents but a fraction of the medical school’s $580 million budget, but it may signify the onset of a new kind of relationship between the school and its affiliates.

Before the deal, Harvard was probably the only medical school in the country that didn’t derive financial support from its teaching hospitals. The school does not own its teaching hospitals, as do most others.

The peculiar arrangement means Harvard Medical School has been unusually dependent on government research funding and endowment income, which exhibit cyclical variations beyond the control of the school.

The ongoing worldwide financial crisis thus hit Harvard Medical hard: Harvard University’s endowment fell by 27%, to $26 billion during fiscal year 2009. That caused a 20% reduction in endowment income for the medical school.

In response, Harvard Medical School froze salaries and dropped 70 FTEs from its labor force via layoffs and early retirement in 2009. It expects to break even in the current fiscal year, but needs more money to expand programs and develop new ones so it can maintain its exalted status.

At a meeting last summer involving medical school dean Jeffrey Flier and teaching hospital execs, Massachusetts General Hospital CEO Peter Slavin said Flier “had to convince us this is the fairest thing to do.’’

Although the Harvard teaching hospitals are profitable, insurers, politicians and regulators are all pressuring them to cut costs.

In return for their largesse, the hospitals asked the medical school to handle physician promotions more quickly, among other things.

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ABIM Sanctions Cheating Doctors

July 15th, 2010 | No Comments | Source: Amednews

Last week, the American Board of Internal Medicine sanctioned 139 physicians for sharing test questions and answers from the board’s certification test.

The move came a few months after the ABIM sued New Jersey-based Arora Board Review for theft of trade secrets and copyright infringement. The sanctioned physicians had disclosed actual board questions to Arora while participating in one of its exam prep courses.

thatsano no 300x253 ABIM Sanctions Cheating DoctorsABIM and Arora reached a settlement in the case in which Arora’s manager agreed not to offer a live board review course. Terms of the agreement did not require Arora to admit wrongdoing.

ABIM CEO Christine Cassel told AMedNews that her organization became aware of the issue after stumbling upon copyrighted exam questions on Arora’s website.

“At the Arora Board Review courses, [the manager] was not only bragging that he had ABIM questions but soliciting people who remembered questions to report them back to him,” Cassel said.

Physicians must sign a “pledge of honesty” 3 separate times during the exam. The pledge warns test-takers not to disclose, copy or reproduce test-related material, and threatens penalties for those who do.

Camille Miller, the lawyer who represented Arora in the suit, said that Arora disagreed with ABIM’s actions. “Physicians routinely discuss examination content with others,” she said. “ABIM has not apparently enforced this consistently against other physicians.”

Penalties levied by ABIM against the physicians may include revocation of board certification or suspension of certification for up to 5 years depending on the particular offense. Noncertified physicians would need to wait for a year or more before retaking the test.

The physicians have 2 months to appeal the ABIM’s decision. After that, the board will start notifying state medical licensing boards of its actions.

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