Medical Device Daily Washington Editor
The Advanced Medical Technology Association (AdvaMed; Washington) reported yesterday the publication of guidelines for direct-to-consumer (DTC) advertising for member companies, but the guidelines apply only to television ads, leaving out perhaps the primary vector for medical device marketing, the Internet. And unlike the code of ethics, adherence is not mandatory for member companies, leaving open the question of what the guidelines accomplish.
Steve Ubl, president/CEO of AdvaMed, noted "today's patients are voracious consumers of information," adding that "our DTC principals go beyond what is required by law." However, he also acknowledged that the document "speaks only to broadcast ads for non-OTC devices." As to why the guidelines omit other mediums for advertising, Ubl said "the principals take a dramatic step forward" and noted that "if there's an ad that's running on broadcast and on YouTube, it would be covered" by the guidelines.
The issue is not on the front burner on Capitol Hill at this point given the greater prominence of patent reform and pre-emption of state liability laws by FDA regulations for PMA devices but Sen. Herb Kohl (D-Wisconsin) has taken up the question of DTC ads for devices in his committee, the Senate Special Committee on Aging. In a statement dated Sept. 17, 2008, released for a hearing conducted that day, Kohl remarked that even though the sums spent on device advertising are dwarfed by the amount spent to advertise drugs, "a number of DTC ad campaigns have been launched [recently] in an effort to market specific and often complex medical device products." Kohl also said FDA "has raised concerns about advertising [for] restricted medical devices," questioning whether those ads display risk and safety information with a sufficient prominence to catch the viewer's attention. Despite the congressional interest, Ubl maintained that "the goal [of the guidelines] is not to avoid legislation. The goal is to ensure that patients have accurate and fair information."
Among the features of the guidelines is a requirement that spokespersons who endorse a device in a television ad "should be actual users of the product, or their relationship to the product should be disclosed." Any statements by such individuals "must be able to be substantiated as if the representations were made by the manufacturer." The guideline document also suggests that any spokesperson's experience "should reflect what consumers can generally achieve with the advertised product in actual, albeit variable, conditions of use" unless "the generally expected performance in the depicted circumstances [is] clearly and conspicuously disclosed."
FDA eyes MRI and metal in patches
The fields generated during magnetic resonance imaging (MRI) procedures can, like microwave oven energy, heat up metallic devices, but up to now, the metal content of transdermal patches has not been seen as a potential problem in this context. However, FDA has published a safety alert in connection with roughly half a dozen instances of patients with patches receiving mild burns when undergoing MRI exams.
Sandra Kweder, MD, deputy director of the Office of New Drugs at FDA's Center for Drug Evaluation and Research said during yesterday's conference call that "some, but not all these patches contain aluminum or other metal" the consequences of which are that the patch could end up "conducting electricity and generating enough heat to cause a skin burn." She noted that "even a patch that is clear ... may have a very small amount of metal that could overheat."
Kweder noted that the agency has "only a few reports" of such incidents, characterizing the resulting burns as akin to "bad sunburns." FDA is looking at how to approach the use of a warning label on a patch product, but has only started on the effort and has yet to determine whether the warning would go directly on the patch or on the product's package.
"Most MRI facilities ask patients to remove patches, but it may not be [a] uniform practice," Kweder noted. In response to a question about whether the agency could require that radiology technicians ask patients about patches, she said "we don't have any jurisdiction," but noted that the American College of Radiology (Reston, Virginia) "already has guidelines that recommend technicians ask about patches." Kweder said "we will be working with them and other stakeholders" to get the word out.
Brain cancer more common in Northeast
The prevailing view of higher education is that the northeastern U.S. has the highest percentage of adults with a college diploma, so it may strike one as ironic that a recent report by the Agency for Healthcare Research and Quality indicates that this region appears to be the home of the highest rates of brain cancer in the nation.
According to a statement published along with the statistical brief for the agency's Hospital Cost and Utilization Project (HCUP), those living in the Northeast "are one-third more likely than those in the South or West to be hospitalized for treatment of brain cancer or to have brain cancer when they are hospitalized for another illness or complication." The rate of hospitalization in the Northeast in 2006 was about 30 for each 100,000 residents, substantially higher than the 25 per 100,000 in the Midwest and the 23 per 100,000 in the South.
However, the statement's dark cloud was accompanied by the silver lining of news that "nationally, the hospitalization rate for brain cancer remained stable since 1995 roughly about 35,000 hospital stays a year." This number presumably deals with initial diagnoses, given that the statement also notes that another 38,000 admissions were chalked up to brain cancer, "mostly for chemotherapy or radiotherapy to continue treatment, or for convulsions, pneumonia or other complication from the disease." This number, according to AHRQ, is up 18% since 1995.
As one might guess, the disease is somewhat selective by sex. Among those over the age of 65, men were 62% more likely than women to end up in the hospital primarily for brain cancer, and 55% more likely as a secondary diagnosis. AHRQ also notes that 4.4% of patients admitted for brain cancer died in the hospital, down from 6.2% in 1995, but the HCUP report does not include numbers on the destinations of those patients upon discharge.