Advertising: Tales of Reading in Reintroducing a Color Device

Make that Nook Color, the e-reading tablet that Barnes & Noble is hoping to reintroduce to consumers in an advertising campaign that begins on Monday.

In gently singsong language that evokes Dr. Seuss — sure enough, “The Cat in the Hat” makes a brief appearance later in the ad — a commercial makes a general pitch for reading as it depicts people, old and young, utterly absorbed in their books while the world goes on around them.

?

A series of dreamy sequences shows a dark-haired boy in a hoodie sweatshirt, reading in a park and blissfully paying no attention as two other boys and a dog noisily brush past him. A young girl sits cross-legged on a dining-room rug, a Nook in her lap, as she absentmindedly tucks a stray lock of hair behind her ear. A couple is stretched out in bed, locked in their own worlds, she with a Nook and he with a book. Four people sit, still as statues, reading, on the stairs of a public building as passers-by rush down the steps.

One print ad bears the tagline “Read Forever,” with a picture of a small boy curled up on a window seat gazing at the screen on his Nook.

The hopeful message? Reading is changing, but it’s not going away.

There are no Barnes & Noble stores in the ads, a nod to the transformation that is under way in the publishing industry. As e-books have taken off, foot traffic in brick-and-mortar stores has decreased, a sure sign that more consumers are doing their book-shopping from home. (Or wherever they and their e-readers happen to be at the moment.)

Barnes & Noble, which operates the nation’s largest chain of bookstores, is hoping many of those purchases will happen on the Nook Color, the $249 tablet that the company introduced last year as an addition to its original Nook, a black-and-white reader whose versions are currently priced at $149 and $199.

There are dozens of e-readers and tablets on the market, and many more are expected to arrive this year. But the most prominent players for devices that focus on reading e-books are Barnes & Noble and Amazon, with its popular Kindle.

Amazon still has a significantly larger share of the e-reading market, but Barnes & Noble has surprised many people in the industry with the gains it has made with its Nook, and the two retailers are locked in a battle for e-reading customers.

Barnes & Noble spent more than $30 million on advertising in 2010 but was seriously outgunned by Amazon, which spent more than $150 million, according to Kantar Media, which tracks advertising spending.

?

Last year, an initial campaign to introduce the Nook Color opened on a picture of a Barnes & Noble store, the camera zooming through the entrance and landing on a Nook Color, while Sarah Jessica Parker narrated the voice-over.

This campaign, which was created by Mullen in Boston, part of the Interpublic Group of Companies, was an effort to attach some emotional power to reading and to the Barnes & Noble brand. Mullen was hired as Barnes & Noble’s new agency of record in February.

“We really wanted to reach out to all the readers and get the message out about how wonderful reading is,” said Sasha Norkin, the vice president for digital and channel marketing for BN.com. “The world changes, technology changes, but people love to read, and we’re giving them the best way to read.”

The Nook was first introduced in 2009, two years after Amazon began selling its Kindle. Last year, Barnes & Noble added the Nook Color, a device featuring a seven-inch screen with a backlit LCD display, suitable for reading books, magazines and newspapers, as well as browsing the Web, playing games and listening to music.

The first commercial in the campaign will run on Monday, and a longer 60-second spot will run during “American Idol” on Thursday. Print ads will run in The New York Times and USA Today. On the company’s Facebook page, users will be invited to share their feelings about reading.

Barnes & Noble declined to disclose the total spending on the campaign.

To add authenticity, casting agents were dispatched to find people reading in public places like bus stops and cafes. Some people were recruited to do voice-overs and appear in the commercial, which was shot in naturally lighted locations in San Francisco and Los Angeles. They eventually numbered more than half of the people on screen, while the rest were actors.

“It transcended age, race, gender,” said Tim Vaccarino, the group creative director for Mullen. “We wanted to find a collection of people who represented this community of readers.”

 

Medical Experts Dispute a Hospital’s Claims on Heart Device Data

This month, University Medical Center of Southern Nevada said in a statement, “results to date show significantly improved outcomes for our cardiac patients” who got heart implants made by a little-known company, Biotronik. The statement was attributed to Kathleen Silver, the chief executive of the hospital.

Ms. Silver issued that statement after an article in The New York Times reported that cardiologists there switched in 2008 to using Biotronik devices after that company started paying them thousands of dollars in consulting fees.

A hospital spokeswoman later said in response to a reporter’s question that Ms. Silver’s comments were based on data drawn from a national registry of heart patients who received an implanted defibrillator. University Medical Center also provided The Times with limited data from that registry that it said backed its contention.

But several experts knowledgeable about that defibrillator database said in separate interviews that it did not track how device recipients fared after they left a hospital. As a result, it cannot and does not provide data to hospitals or manufacturers about the long-term performance of any company’s device. It also does not produce data that can be used to compare the performance of competing implants made by different companies.

“To saying that we are doing better is a bridge too far for the data they have,” said Dr. Jeptha Curtis, an assistant professor of medicine at Yale, who has worked on research studies involving registry data.

Told of the experts’ assessments, Danita Cohen, the spokeswoman for the Las Vegas hospital, responded in writing by stating, “By way of clarification, U.M.C. did not intend to say that our better outcomes can be attributed to a particular device.”

She added that the hospital’s remarks about “improving patient outcomes” were intended to mean that its use of the defibrillator database was helping it monitor its performance.

The hospital’s disputed claims may intensify scrutiny of the ties between the Las Vegas physicians, Biotronik and a company called Western Medical that acts as the company’s sales representative in Nevada and several other states. Those ties are currently under review by state officials in Nevada. The Justice Department started a separate investigation last year into Biotronik’s sales and marketing practices.

The Times article focused on relationships between a device industry sales official named Caesar Fonte and cardiologists at a Las Vegas practice, Nevada Heart and Vascular. Before 2008, when Mr. Fonte worked at Boston Scientific, a defibrillator producer, the same cardiologists were paid consultants to that company and almost exclusively used its devices, hospital data shows.

Then in 2008, Mr. Fonte quit Boston Scientific and started Western Medical, the Biotronik distributor. The implant specialists at Nevada Heart and Vascular then became paid consultants to Biotronik and switched to using its devices in nearly all patients.

Both Biotronik, the physicians and Mr. Fonte have rejected any suggestion that the consulting fees were inducements to get them to use the company’s devices.

The defibrillator database is part of the National Cardiovascular Data Registry, a project run by the American College of Cardiology Foundation, in conjunction with a professional medical group, the Heart Rhythm Society. It is often referred to as the ICD registry, which is short for implantable cardioverter-defibrillator, the device’s formal name.

In 2004, Medicare mandated the creation of a national ICD registry as a condition for approving payments for defibrillators for a new class of patients, for whom evidence of a benefit was equivocal. Implant makers, who have realized vastly added sales from the Medicare ruling, supported the registry for one year then cut back financing. Its is now underwritten by hospitals, but limited financing has restricted the data it can collect.

Essentially, during a procedure to implant a defibrillator, information is collected about areas like a patient’s heart function and other medical conditions. If an existing defibrillator is being replaced by a new one, a hospital can also indicate one of several reasons why such a replacement is being performed.

The information from the national ICD registry provided by University Medical Center to The Times reflected data from two of those device replacement fields. It showed that for a four-year period between 2007 and 2010, no device had been replaced at University Medical Center because it had been recalled or because it had malfunctioned.

Earlier, when providing the data, Ms. Cohen, the hospital spokeswoman, said that its results were “highly significant” when compared with the national average for such replacement reasons. The hospital added that Biotronik has not issued any recent device recalls.

Experts like Dr. Curtis said, however, that the hospital’s data was effectively meaningless because there was no way of knowing from it whether a device being replaced at U.M.C. had been initially implanted there, or whether devices implanted at U.M.C. were later replaced elsewhere.

“If they are thinking that no news is good news from the registry, then they are misunderstanding what function the registry is performing,” said another registry expert at Yale, Dr. Harlan Krumholz.

The national ICD registry does report back to hospitals about in-hospital complication rates related to device implantation procedures so they can compare it with the national average. Asked for its complication rate, U.M.C. declined to release it.

 

Medical Experts Dispute a Hospital’s Claims on Heart Device Data

This month, University Medical Center of Southern Nevada said in a statement, “results to date show significantly improved outcomes for our cardiac patients” who got heart implants made by a little-known company, Biotronik. The statement was attributed to Kathleen Silver, the chief executive of the hospital.

Ms. Silver issued that statement after an article in The New York Times reported that cardiologists there switched in 2008 to using Biotronik devices after that company started paying them thousands of dollars in consulting fees.

A hospital spokeswoman later said in response to a reporter’s question that Ms. Silver’s comments were based on data drawn from a national registry of heart patients who received an implanted defibrillator. University Medical Center also provided The Times with limited data from that registry that it said backed its contention.

But several experts knowledgeable about that defibrillator database said in separate interviews that it did not track how device recipients fared after they left a hospital. As a result, it cannot and does not provide data to hospitals or manufacturers about the long-term performance of any company’s device. It also does not produce data that can be used to compare the performance of competing implants made by different companies.

“To saying that we are doing better is a bridge too far for the data they have,” said Dr. Jeptha Curtis, an assistant professor of medicine at Yale, who has worked on research studies involving registry data.

Told of the experts’ assessments, Danita Cohen, the spokeswoman for the Las Vegas hospital, responded in writing by stating, “By way of clarification, U.M.C. did not intend to say that our better outcomes can be attributed to a particular device.”

She added that the hospital’s remarks about “improving patient outcomes” were intended to mean that its use of the defibrillator database was helping it monitor its performance.

The hospital’s disputed claims may intensify scrutiny of the ties between the Las Vegas physicians, Biotronik and a company called Western Medical that acts as the company’s sales representative in Nevada and several other states. Those ties are currently under review by state officials in Nevada. The Justice Department started a separate investigation last year into Biotronik’s sales and marketing practices.

The Times article focused on relationships between a device industry sales official named Caesar Fonte and cardiologists at a Las Vegas practice, Nevada Heart and Vascular. Before 2008, when Mr. Fonte worked at Boston Scientific, a defibrillator producer, the same cardiologists were paid consultants to that company and almost exclusively used its devices, hospital data shows.

Then in 2008, Mr. Fonte quit Boston Scientific and started Western Medical, the Biotronik distributor. The implant specialists at Nevada Heart and Vascular then became paid consultants to Biotronik and switched to using its devices in nearly all patients.

Both Biotronik, the physicians and Mr. Fonte have rejected any suggestion that the consulting fees were inducements to get them to use the company’s devices.

The defibrillator database is part of the National Cardiovascular Data Registry, a project run by the American College of Cardiology Foundation, in conjunction with a professional medical group, the Heart Rhythm Society. It is often referred to as the ICD registry, which is short for implantable cardioverter-defibrillator, the device’s formal name.

In 2004, Medicare mandated the creation of a national ICD registry as a condition for approving payments for defibrillators for a new class of patients, for whom evidence of a benefit was equivocal. Implant makers, who have realized vastly added sales from the Medicare ruling, supported the registry for one year then cut back financing. Its is now underwritten by hospitals, but limited financing has restricted the data it can collect.

Essentially, during a procedure to implant a defibrillator, information is collected about areas like a patient’s heart function and other medical conditions. If an existing defibrillator is being replaced by a new one, a hospital can also indicate one of several reasons why such a replacement is being performed.

The information from the national ICD registry provided by University Medical Center to The Times reflected data from two of those device replacement fields. It showed that for a four-year period between 2007 and 2010, no device had been replaced at University Medical Center because it had been recalled or because it had malfunctioned.

Earlier, when providing the data, Ms. Cohen, the hospital spokeswoman, said that its results were “highly significant” when compared with the national average for such replacement reasons. The hospital added that Biotronik has not issued any recent device recalls.

Experts like Dr. Curtis said, however, that the hospital’s data was effectively meaningless because there was no way of knowing from it whether a device being replaced at U.M.C. had been initially implanted there, or whether devices implanted at U.M.C. were later replaced elsewhere.

“If they are thinking that no news is good news from the registry, then they are misunderstanding what function the registry is performing,” said another registry expert at Yale, Dr. Harlan Krumholz.

The national ICD registry does report back to hospitals about in-hospital complication rates related to device implantation procedures so they can compare it with the national average. Asked for its complication rate, U.M.C. declined to release it.

 

Breast Device Recall Made Most Severe

The recall of a medical device that left particles of tungsten in women’s breasts has been classified as the most serious type of recall, one involving “situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death,” the Food and Drug Administration said on Wednesday.

The device, the Axxent FlexiShield Mini, was a pad made of tungsten and silicone rubber that was temporarily placed inside breast incisions during an unusual procedure in which women were given an entire course of radiation treatment in one dose after undergoing a lumpectomy for cancer. The pads were used to help direct the radiation beam and shield healthy tissue. But the pads were flawed, and left the breast tissue and chest muscles riddled with hundreds of tungsten particles.

It is not known if tungsten is dangerous because relatively little research has been done on its long-term health effects in humans. But it shows up on mammograms and may make them difficult to read, especially troubling for women who have had breast cancer and worry about recurrences. The metal particles resemble calcium deposits, which can indicate cancer.

That the tungsten shows up on mammograms is what made the recall Class I, the most serious type, said Karen Riley, a spokeswoman for the Food and Drug Administration. She said the particles could interfere with diagnosis because they can be mistaken for cancerous calcifications or may hide real calcifications. Twenty-nine women are known to have been affected: 27 at Hoag Memorial Hospital Presbyterian in Newport Beach, Calif., and 2 at Karmanos-Crittenton Cancer Center in Rochester Hills, Mich. So far, 16 have had follow-up mammograms six months after their surgery, and all 16 were found to have tungsten particles.

Some of the women, concerned that the tungsten could be harmful, are considering having mastectomies to rid themselves of the particles. Seven are suing Hoag and the device manufacturer, according to Jeffrey Milman, a lawyer in Irvine, Calif., who is representing the women.

Mr. Milman said that for the purposes of the lawsuits, the government’s decision to classify the recall as serious was “icing on the cake.” The device was made by a company called Xoft, which was subsequently bought by another company, iCad.

The Axxent FlexiShield Mini had been cleared by the drug agency in June 2009 in an abbreviated process used for devices that are considered equivalent to products already on the market. That process, known as 510(k), takes less time than the procedure used to approve a new device, and it generally does not require tests on humans.

The shields, taken off the market in February, were cut to fit each patient, and Ms. Riley said the tungsten particles were shed after the cutting. But why that occurred is not clear, because the shields were meant to be cut and were made with that in mind.