BB&T Executive Editor

Consumers Union (CU; Washington) last month filed a petition with the FDA requesting that it require all consumer advertisements for implantable devices — such as knee, hip and heart valve replacements, cosmetic implants and heart stents — carry a warning about the possibility of dangerous infections or failures of the devices once they are in the body.

The petition asks that these advertisements provide two types of information: "the very real danger of healthcare-acquired infections that can and do result from surgery and follow-up care; and the expected life span of the device before failure occurs. It says that both circumstances - the risk of infections and a device outliving its life span "can and do cause death or serious morbidity and expense.

Implantable device makers recently have launched a wave of direct-to-consumer (DTC) advertisements for their products, and Consumers Union said a review of these ads shows that most lack basic information about the possibility of severe or fatal side effects.

"There is no question that many of these devices can restore high quality of life in patients, but we are concerned that serious and possibly deadly side effects like infections are consistently understated in these device ads," said Bill Vaughan, senior policy analyst for Consumers Union, publisher of Consumer Reports. "We're asking the FDA to require clear warnings about the dangers of infection during and following such surgery, and information about how long the devices are likely to last once they are in the body," Vaughan said.

The petition says that some healthcare facilities "do a better job than others in preventing infections and some make this information available to the public as a result of State laws or voluntary disclosure." Thus it says that all implanted devices carry a warning statement, and it provides such a statement as an example:

"The surgery and care involved in the placement of this device may result in an infection, or other adverse events, that can lead to death or injury. Be sure to ask your doctor and hospital about infection rates at the facility where the surgery will be performed. In addition, ask your doctor about the long-term failure rates so that you are aware of when the implant is likely to need to be replaced."

The petition goes on to say that it has reviewed device advertisements, it charges that adverse effects "including death - are consistently understated" in the ads, and it encourages the FDA to review these ads. But it says the specific purpose of the petition is to recommend to the FDA it "review the quality of all device ads" and that consumers "be advised to seek out facilities with the strongest anti-infection programs and devices with long-term data about failure rates."

The petition assures that it is not trying to discourage people from seeking out device therapies. But then adds: "we do believe that unintended side effects … can be minimized if the public is better educated to avoid facilities which are not practicing the highest level of anti-infection practices.

The petition sites one of its own articles in Consumer Reports, "Problems on the Rise," which cites a Centers of Disease Control & Prevention report that "clearly shows hip and knee prosthesis surgery to be a serious source of infection, in some cases a high-risk source, and in some of the NNIS reporting hospitals, the infection rate may run as high as 5% or more."

That article also cites the Agency for Healthcare Research and Quality (Washington) that the "complication of device, implant or graft" was the third most common of the principal diagnoses for hospital stays with MRSA infection in 2004. CU acknowledges that this category includes skin grafts, but says "clearly devices and implants contribute to the total of 23,500 reported 'stays with MRSA infection."

It adds: "Between 1991 and 2001 a study was performed on the 222,684 cases of total knee replacements in California. In the first 90 days of discharge, the study found 1,176 deaths (0.53% rate), 1,586 infections (0.71%), and 914 pulmonary emboli (0.41%). The rates were significantly higher when surgery was performed in low-volume hospitals or on above-average age or co-morbidity patients.

It goes on to cite another study reviewing another recent study reviewing 2003 nationwide U.S. data to determine the incidences of primary total, partial, and revision hip replacements, and to assess short-term outcomes and factors associated with those outcomes.

It says that this study reviewed more than 300,000 hip procedures and that the in-hospital mortality rates associated with these three procedures were 0.33%, 3.04%, and 0.84%, respectively; perioperative complication rates associated with the procedures were 0.68%, 1.36%, and 1.08% respectively; for deep vein thrombosis or pulmonary embolism, 0.28%, 1.88%, and 1.27% for decubitus ulcer; and 0.05%, 0.06%, and 0.25% for postoperative infection. Rates of readmission for any cause within 90 days ran between 9% for total replacement to 21% for partial.

"Clearly," CU says in its petition, "these are very serious operations, infections occur, and consumers need to consider these side effects.

"Other Department of Health and Human Services agencies recognize the importance of fighting HAIs and empowering consumers to understand the dangers of infection and the efforts individual facilities are taking to fight infection."

The organization said it was unable to find an ad advising consumers of infections or advice to seek out surgical providers that have low infection rates. As one example, it cites an ad by Biomet (Warsaw, Indiana), saying that it directs readers to a website. It says the website "lists a separate risk page and seems unusual in giving a full paragraph to possible complications." But it says the Biomet website video ad (, featuring Mary Lou Retton, fails to mention (as of November 28, 2007) infection or how serious the side effects can be."

Among the petition's concluding statements, it says: "The FDA Amendments Act of 2007 (PL 110-85) creates a new section 503B, which includes stronger authorities for the FDA to require pre-review and specific disclosures to ensure that consumers are warned in DTC advertisements about potential dangers and side effects. Clearly, Congress expects stronger FDA oversight of these advertisements."

Hospital charges increasing despite outpatient care growth

Recent data from the Agency for Healthcare Research and Quality (AHRQ; Washington) suggests that hospital charges continue their upward trend despite the push toward outpatient treatment. New numbers from the Healthcare Cost and Utilization Project (HCUP) analysis indicate that the nation's hospitals "billed nearly $875 billion in total charges in 2005 for in-patient hospitalizations," an increase of 89% over 1997, when hospitals billed private and public payers for about $462 billion.

The 2005 charges were associated with slightly more than 39 million stays, a jump of only about 13% over the baseline year of 1997, when hospitals discharged about 34.7 million patients. Hence, the per-discharge costs were much higher than the rate of hospitalizations. (The figures do not include hospital outpatient care, emergency care for patients not admitted or physician fees involved with those admissions.)

As expected, a small number of diseases and conditions consumed a disproportionate share of charges. The five most expensive conditions consumed roughly 20% of all hospitalization costs; three of the top five were related to cardiovascular disease. First place went to coronary artery disease, which rang up almost $46 billion in hospital charges in 2005 and accounted for 5.3% of all hospitalization costs. Second place was for pregnancies and delivery of newborns at nearly $44 billion (5%).

Despite the nearly identical charges for these two conditions, the number of stays for CAD treatment more than four times more frequent than pregnancies/deliveries: 4,700 vs. 1,100 vs., making CAD treatment four times more costly.

Care and treatment of newborns generated more than $35 billion in costs for 4% (slightly more than 4,400 admissions). The last two of the top five spots were acute myocardial infarction (AMI) and congestive heart failure (CHF), both accounting for about $30 billion in 2005. The total cases of CHF outnumbered those of AMI 1,090 to 662, indicating that infarction was substantially more expensive to treat, suggesting what payers and hospitals might find most interesting in terms of cost containment.

According to the report, Medicare paid nearly half of all these charges at 47%, Medicaid another 14.2% for a total charges to CMS of 61.2%, or about $535 billion. Private insurance accounted for less than a third (31.1%), about $272 billion. The balance was divided by the uninsured at 4.4% and a catch-all category for missing data and other sources of reimbursement at 3.2%.

The data were drawn from community hospitals, defined in the report as "short-term, non-federal, general and other hospitals," a category that excludes long-term care hospitals and other specialty units.

Report: economic impact of Ohio bioscience nears $150 million

More than 800 bioscience-related entities are calling Ohio home, according to a report by BioOhio (Columbus) released in mid-December. In 2006, the overall economic impact of Ohio-based bioscience was $146 billion, representing 17.6% of Ohio's total economic output. Bioscience also directly and indirectly sustained 1.2 million jobs in Ohio as of 2006. BioOhio said it teamed with consulting firm Tripp Umbach and employed the IMPLAN input-output model to estimate the impact of bioscience economic events in the state.

In the report, BioOhio's definition of the bioscience industry includes three integrated sectors: commercial bioscience entities, hospitals and healthcare providers, and medical colleges. The commercial bioscience sector alone accounted for a $27.3 billion overall economic impact and 48,485 direct jobs in 2006.

When indirect and induced jobs are factored, the commercial bioscience employment figure jumps to 128,206, the organization said.

Tony Dennis, president/CEO of BioOhio, told BB&T that several factors are driving bioscience growth in Ohio. "At the top of the list is we have finally realized as a state that we have tremendous assets in bioscience, and are now fueling and leveraging those assets," Dennis said.

In February 2002 the state initiated a $1.6 billion program, dubbed the Third Frontier Initiative Project, to expand its high-tech research capabilities, promote innovation and create high-paying jobs. "Bioscience is getting the lion's share of those dollars," Dennis said. One example is the Wright Center of Innovation in Biomedical Imaging at The Ohio State University (Columbus), which Dennis called a "world-class center in terms of imaging at Ohio State."

The Third Frontier Initiative is designed to continue until 2012; however, Dennis said the organization is in discussions with state leaders to continue the program beyond that. "One of the hallmarks of it is that the state asked for a two-to-one match from private industry and in fact has gotten almost a nine-to-one match in terms of dollars," Dennis said.

Public-private partnerships that leverage assets of Ohio's academic institutions and also engage industry have also driven much of the state's bioscience growth, he said. For example, one of the latest and the largest grants awarded through the program was to the Cleveland Clinic Foundation to create the $240 million Global Cardiovascular Innovation Center.

Cleveland, Cincinnati and Columbus anchor the three Ohio regions that collectively account for 89% of the state's commercial bioscience industry economic impact and 90% of the state's commercial bioscience employment impact in 2006, BioOhio reported.

In northeast Ohio, commercial bioscience was responsible for an $8.6 billion overall economic impact and 39,247 total jobs (direct, indirect, and induced).

The commercial bioscience sector in southwest Ohio boasted an $8.3 billion economic impact and 36,700 total jobs. In central Ohio, commercial bioscience had an economic impact of $6.5 billion and contributed 30,152 total jobs.

BioOhio said medical device and equipment manufacturers are the top employer (12,392), while agricultural biotechnology contributed the largest direct economic impact ($6.1 billion) in 2006.

Website gives improved access to hospital pricing

The Michigan Health and Hospital Association (MHA; Lansing) in lalte December launch a new web site enabliing consumers, for the first time, to compare prices of the most common procedures at each of the state's 146 non-profit hospitals. The website - at - was created, MHA said, in response to consumer demands for greater "transparency" in healthcare pricing.

The MHA-sponsored site lists average charges and average payments for the 50 most frequent inpatient and 50 most frequent outpatient medical procedures at each of Michigan's 146 non-profit hospitals. For example, the charge for hip or knee replacement varies from $28,500 at William Beaumont Medical Center to $33,949 at Henry Ford Hospital to $42,653 at Harper University Hospital, all Detroit-area institutions.

The prices listed on the MHA site include only the cost of the procedures, not all charges that a patient may incur during a hospital stay, such as doctors' fees. The site shares information on how well Michigan hospitals served patients in four treatment areas: heart attacks, heart failure, pneumonia and surgical infections, these comparisons based on averages for the nation and the state.

MHA said the attention is to make businesses and employees more aware of the cost and the quality of those procedures largely covered by health insurance. It said it believes making such information available will make hospitals more efficient and hold them more accountable to consumers.

Roy Lamphier, VP of insurance services for the Detroit Regional Chamber of Commerce, told The Detroit News that the website is "a step in the right direction" as people shoulder more of their healthcare costs and companies ask employees to be more accountable for their health. However, Sofia Kosmetatos, who covers health issues for The News, said that the site "is not likely to change where most people seek care - the closest hospital in an emergency, or to the one with which their doctor is affiliated for an elective procedure." She also noted that it probably won't not reduce procedures prices since prices are mostly negotiated with insurers.

MIHospitalInform's data comes from the Centers for Medicare & Medicaid Services, the association calling these good indicators of pricing and quality. The hospital association said it plans to add information in the future, such as data from other payers and physicians.

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