Archive for May, 2010

Gene Test Helps Heart Transplant Recipients

May 28th, 2010 | No Comments | Source: NEJM, Wall Street Journal

Rejection of the donor organ is a frequent and sometimes life-threatening complication of heart transplantation. It is best handled if caught early, and since early rejection is typically asymptomatic, physicians had heretofore been required to perform regular biopsies to screen for rejection of the transplanted heart.

newheartcells 300x199 Gene Test Helps Heart Transplant RecipientsThe biopsy is expensive and not without risk however, so scientists have long searched for a non-invasive alternative to diagnose rejection.

That search may have yielded results. In a presentation at last month’s meeting of the International Society for Heart & Lung Transplantation, Michael Pham and colleagues from Stanford University showed that a genetic test reduced the need for biopsies in selected patients.

The gene test is known as Allomap. It is marketed by XDx and has been used on 7,000 transplant recipients so far. It costs about $3,000, or 25-40% less than the biopsy.

The study by Pham’s team included 602 transplant recipients. It showed that Allomap was as effective as routine biopsies in preventing serious episodes of transplant rejection like heart failure, the need for a re-transplant or death.

The study was limited to patients who were at low risk for rejection and had undergone the procedure at least 6 months prior to enrollment. Nineteen months after randomization, 14.5% of patients that were followed with the genetic test and 15.3% of those followed with routine biopsies suffered a major complication.

“You’re not going to harm patients by reducing the number of biopsies,” Pham told the Wall Street Journal.

Pham noted that his team’s findings could not be extrapolated to patients that had received a transplant within the last 6 months or to those at high risk for rejection.

The study appears in the New England Journal of Medicine.

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Computer-based Memory Games Don’t Deliver

May 27th, 2010 | No Comments | Source: Wall Street Journal

Tens of thousands of people use computer-based brain-training exercises to boost memory and mental fitness. These people will be disappointed to learn that a recently published study suggests the tools may not work.

foiledagain 300x199 Computer based Memory Games Dont DeliverIn the 6-week study, Jessica Grahn and colleagues at the Medical and Research Council’s Cognition and Brain Sciences Unit in Cambridge, England randomized 11,430 healthy participants to one of 3 groups. The first engaged in online games designed to improve general intelligence skills like problem-solving and reasoning. The second group performed exercises aimed at increasing attention, short-term memory and mathematical skills—the focus of commercial brain-training programs. The control group browsed the Internet in search of answers to general knowledge questions.

Participants performed these activities for at least 10 minutes, 3-times each day.

Grahn’s team found that participants in the brain-training (second) group improved in the tasks that they practiced, but their improvement was about the same as that made by the control group. No groups showed improved cognitive skills that weren’t specifically targeted in their tasks.

The brain training industry is focused for the moment on software offerings and online programs. It generated $265 million in North American revenues last year, up from $225 in 2008. About 40% of these revenues came from consumers. The remaining came from schools and retirement communities.

Industry spokespeople said the study was flawed. “It’s not brain training,” Alvaro Fernandez, CEO of SharpBrains told the Wall Street Journal. Cognitive improvements can only be expected, he said, “after more than 15 hours of training and where each session lasts at least 30 minutes.”

Steven Aldrich, CEO of Posit Science, a brain-training vendor, added that the “study overreaches in generalizing that since their methods did not work, all methods would not work.”

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Google Approached by Governments

May 25th, 2010 | No Comments | Source: Washington Post

Last week, Google released a list of governments that had requested various forms of private information from the search giant’s own data bases, and demands made by these governments to censor its applications or remove certain content.

Whatstrangecritters1 300x197 Google Approached by GovernmentsGoogle said it disclosed the information in order to reveal an increasing trend by governments to block information on the Web. More than 40 governments censored Google-associated information in 2009, compared with just 4 in 2002.

“We at Google believe that greater transparency will lead to less censorship online,” David Drummond, Google’s chief legal officer told the Washington Post.

According to Google, Brazil and the US made the most requests. During the second half of 2009, these countries made more than 3,000 requests, particularly concerning YouTube and Orkut (a social networking site that is popular in Brazil). 

Germany was also near the top of the list. Most of that government’s requests concerned removing pro-Nazi material, according to the company.

Google’s figures are a bit difficult to interpret since Google counts a request to take down one Web address the same way as a request to remove hundreds of sites.

Google stated that many requests by governments seemed legitimate. Law enforcement agencies, for example, often request the removal of child porn sites or videos promoting violence or racial hatred.

Of note, Google’s disclosure included no information about China because, it said, China looks at “censorship demands as state secrets, so we cannot disclose that information at this time.” China is known to have erected firewalls that  prevent its citizens from accessing certain information, and other technological barricades that prevent certain users from communicating with others.

Google’s report was not obviously related to its decision last month to pull its search business out of China.

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FDA Takes Heat in Heparin Case

May 24th, 2010 | No Comments | Source: Wall Street Journal

A congressional investigation into the FDA’s handling of the 2008 outbreak of deaths and anaphylactic reactions caused by contaminated heparin from China has revealed that the agency failed to pursue “specific, credible leads” that could have fingered the culpable organizations.

spoiledrotten 300x225 FDA Takes Heat in Heparin CaseThe FDA never did say who was responsible for the outbreak, which caused at least 80 deaths and several hundred severe reactions, according to Joe Barton, the ranking Republican on the House Energy and Commerce Committee.

Nearly all the world’s heparin comes from Chinese farms, where ingredients for the widely-used blood thinner are derived from pig intestines. China-based pharmaceutical companies process the raw ingredients and export them around the world.

In February 2008, US hospitals and dialysis centers began reporting severe allergic reactions and deaths associated with heparin. Six weeks after the outbreak began, the FDA announced it was caused by a contaminant, chondroitin sulfate, that had been added to the raw product to stretch supplies.

In one instance cited by Barton, a foreign “respectable regulatory government agency” tipped-off the FDA that a Chinese company was producing tainted heparin. The FDA never pursued the lead.

A letter penned by Barton also cites an internal FDA memo from April, 2008 indicating the agency was aware that one company, Chongqing Imperial Bio-Chem, was supplying tainted heparin to the US.

Although the FDA subsequently banned US imports from Chongqing, Barton’s letter accuses the FDA of failing to explore more thoroughly the possibility that the company was centrally involved in the scam. In an inspection of the facility later in the year, the letter said, the FDA relied on the company’s president to translate.

A Chinese embassy spokesperson responded that Chinese officials “provided full cooperation to the US in the whole process.”

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FDA to Desalinize US Diet

May 21st, 2010 | No Comments | Source: Washington Post

The Food and Drug Administration wants to reduce salt consumption by Americans in an effort to cut morbidity and mortality from cardiovascular disease.

salt 300x199 FDA to Desalinize US DietThe unprecedented move would be implemented over a decade or more.

It would begin by quantifying salt content in processed foods and progress to the establishment of salt limits in various food categories. Subsequently, these would be ratcheted down over years so that consumers wouldn’t take notice.

At the moment, FDA classifies salt as “generally recognized as safe,” meaning that food producers can add as much as they want. All they have to do is report salt content on nutrition labels.

Americans’ salt consumption has risen steadily for 3 decades as they consume more processed foods and eat out more frequently. Most of us consume twice as much as the government’s daily recommended limit.

Scientists at Stanford and Columbia recently published a study showing that reducing salt intake by 3 grams per day could prevent tens of thousands of strokes and heart attacks per year.

The feds had heretofore tried to coax the food industry to voluntarily reduce salt and educate consumers about its risk. However, a recently released report by the Institute of Medicine has found these approaches have failed.

The FDA’s challenge is that, “historically, consumers have found low-sodium products haven’t been of the quality that’s expected,” according to Todd Abraham, an SVP of research and nutrition at Kraft Foods.

Meanwhile, Morton Satin, who directs technical and regulatory affairs for the Salt Institute, a trade group representing salt producers, believes regulation “would be a disaster for the public.” He added that the scientific evidence linking salt consumption to cardiovascular disease is mixed and that salt intake is not necessarily associated with health problems.

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Tobacco as Candy

May 20th, 2010 | No Comments | Source: MedPageToday, Pediatrics

Camel Orbs, a flavored Tic Tac-like tobacco-containing pellet introduced last year by R.J. Reynolds,  poses a threat to children, according to a new study published in Pediatrics.

Peppermint 300x238 Tobacco as CandyThe smokeless tobacco product is supposed to be used by smokers when they can’t light up. It contains 1 mg of nicotine, about half that received by smoking one cigarette.

This amount can cause nausea and vomiting in a small child (a lethal dose of nicotine for an infant is about 1.0 mg/kg body weight). The problem is made worse by the fact that the Orb contains a highly bio-available form of nicotine.

To reach these conclusions, Hillel Alpert and colleagues from the Harvard School of Public Health  reviewed 13,705 tobacco product ingestion cases by children under 6 years of age that were reported to 61 regional poison control centers between 2006 and 2008.

The scientists counted 13,705 cases of tobacco product ingestion, more than 70% of which involved infants less than 1 year of age. Orbs came in second only to cigarettes themselves as the substance ingested by the kids. There was one death.

In an accompanying editorial, Marisa Cruz and Lawrence Deyton of the FDA Center for Tobacco Products said their agency has requested information from RJR and will be seeking “research around the impact of marketing for dissolvable tobacco products on young people, how adolescents and young adults perceive such products, and whether dissolvable tobacco products may lead to initiation or persistence of tobacco use in this population.”

An RJR spokesperson said the company hadn’t known of any pediatric adverse events caused by Orbs ingestion before the article was published. He added that Orbs taste like tobacco despite the candy-like flavorings and that the packaging meets government standards for child resistance.

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NSA Stops Collecting Certain Data

May 18th, 2010 | No Comments | Source: Washington Post

After receiving an update from intelligence officials about methods used by the National Security Agency to collect electronic data to spy on US citizens in terrorism and espionage cases, the federal court that oversees these activities has raised concerns about their legality.

gimmethat3 300x211 NSA Stops Collecting Certain DataAs a result, the NSA suspended those activities, the officials told the Washington Post.

The officials had briefed the Foreign Intelligence Surveillance Court about “metadata” associated with various kinds of communication, but not its content. “Metadata” includes things like the origin and destination of emails and phone numbers dialed from a particular telephone. 

Analysts can use metadata to determine who suspects are communicating with, and to “detect and anticipate” a plot, the official told the Post. “It’s not a concern over what was being collected,” he said. “It’s a question about whether the law was written in a way that allowed the information to be collected in a way that they were collecting it.”

The NSA had been collecting this metadata with court permission for years before the recent briefing.

House Republicans worry that the new development creates a surveillance gap that could impede the government’s ability to keep US citizens safe from terrorist attacks. 

“This is a basic tool we used to have, and it’s now gone,” one intelligence official lamented. “Every day, every week that goes by, there’s one more week of information we’re not collecting.”

Meanwhile, House Democrats seem confident that NSA Director Keith Alexander and the Justice Department will resolve the matter with alacrity.

The crux of the matter is whether the NSA’s data collection methods conform to the Foreign Intelligence Surveillance Act, which was passed in 1978 to eliminate domestic spying abuses. The law was revised in 2008 to broaden the government’s surveillance authority at the request of the Bush administration.

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Twitter Ad Strategy Update

May 17th, 2010 | No Comments | Source: Washington Post

Last week, Twitter announced plans to derive revenue through advertising. The plan calls for ads on the popular micro-blogging site to look just like actual tweets. Thus, rather than seeing a banner ad for a Big Mac, users will see a sponsored McDonald’s tweet promoting a greasy delight.

twitter Twitter Ad Strategy UpdateAccording to the Washington Post’s Chadwick Matlin, this strategy is well-crafted because it is highly consistent with the formula that has made Twitter popular in the first place.  Twitter’s ads (the ones companies pay for) will appear right in your feed  of unsponsored tweets.

What makes this strategy so well aligned with the essence of Twitter? According to Matlin, self-promotion is what Twitter is, and has always been all about. Businesses and casual users alike load-up their tweets and their feeds with links to their own work. Regardless of the number of followers you have, every tweet amounts to a shill.

The new, sponsored ads will appear at the top of your feed, along with a “Sponsored by . . .” alert at the bottom, to avoid the perception that McDonalds has hacked your feed. They can be retweeted, replied to, and linked to, just like normal tweets.

Twitter is convinced the way it can make sure its ads work is by making sure they’re “resonant.” That word was all over Twitter’s ad announcement, and it’s sure to become a new buzzword for the Web.

Twitter’s general principle is that it’s going to display only ads that users like — the ones that resonate. It’s great in theory, impossible to do in practice. If Starbucks is spending hundreds of thousands of dollars on Twitter ads but its Twitter ads are lousy, is Twitter really going to tell Starbucks to take back its money?

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Manufacturing Gaffes at Genzyme

May 14th, 2010 | No Comments | Source: BurrillReport, NY Times

Ongoing production problems at the factories of biotech giant Genzyme have caused massive disruptions in the lives of people with Gaucher disease and Fabry disease, a pair of rare, inherited conditions in which enzyme deficiencies allow fatty substances to build-up in the body and damage internal organs.

Genzymeproductionfacility 300x275 Manufacturing Gaffes at GenzymeThe factories produce Cerezyme, the enzyme used as replacement therapy for the 1,500 patients with Gaucher disease, and Fabrazyme, the enzyme used to treat about 1,000 patients with Fabry disease.

Genzyme’s production problems began nearly a year ago, after it discovered its main production facility had been contaminated by a virus.

Genzyme initially predicted the shortages would last 2 months, but subsequent glitches have impeded progress. At one point, some vials of the drugs were found to contain particles of fiber, rubber or steel.

The problems are particularly acute for Fabry patients, who can experience cardiac or kidney failure in the absence of drug replacement therapy. Fabry patients have been receiving about 30% of their normal doses during the crisis.

In Gaucher disease, which can cause anemia, bleeding and enlarged livers and spleens, severely affected patients have been receiving full doses of the drug, while others received nothing for months late last year.

“If most businesses run like this they’d be out of business,” one patient, Mark Malone told the New York Times. “Unfortunately, they have the drug we need.”

Henri Termeer, Genzyme’s CEO, acknowledged his company had let patients down. “We have to re-earn our standing with these patients,” he said.

Genzyme says it should be able to supply Cerezyme to all affected patients by May 1. Fabrazyme patients will have to wait until at least later this summer. Genzyme stock, which traded above $72 last year, now trades in the low 50s.

Genzyme booked a $175 million hit to its first quarter earnings in anticipation of a fine it expects the FDA to levy for the mess-up.

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Is Your Doctor Googling You?

May 13th, 2010 | No Comments | Source: WSJ Health Blog

This post originally appeared on EHRbloggers.com.

These days it’s a given that anyone you meet, from prospective employers to next Friday night’s date is probably Googling you. But how would you feel if you knew that practice extended to your psychiatrist?

detective1 200x300 Is Your Doctor Googling You?If anecdotal observations by Brian Clinton, Benjamin Silverman and David Brendel are generalizable, the behavior is common.

Writing the Harvard Review of Psychiatry, the psychiatrists say they have not carried out research on the practice, but they admit having carried out such searches themselves. They claim to have witnessed other physicians conducting patient searches and to have spoken with many colleagues who had done likewise.

“Most patients would probably be shocked that their doctor had the time or the interest to conduct a search,” Brendel told the Wall Street Journal Health Blog. “A good number of people would feel like their privacy had been breached, although a number might be happy the doctor was thinking about them outside of the 15-30 minutes they were spending together.”

In some instances, the practice can save a life, such as when a patient blogs about suicide, but in other cases, doctors appear to be motivated by “curiosity, voyeurism and habit.”

In the absence of ethical guidelines on the matter, the psychiatrists recommend that physicians think through why they are conducting a search beforehand, and consider whether the result will interfere with their relationship with that patient. They should consider asking the patient for consent.

“Some people say absolutely it should never be done; it’s a breach of privacy,” Brendel said. “But many say it should be done as a matter of routine. It’s information that is in the public domain, and it may be information that is clinically relevant.”

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