Consumer Group Calls for Warnings in DTC Advertising
BY LAUREN UZDIENSKI, JANUARY 3, 2008
Consumers Union, the publisher of Consumer Reports, recently petitioned the FDA for warnings about possible infection and device failure to accompany the rosy claims of DTC medical device marketing. However, some suggest the warnings could hinder a patient's care, and risks should be kept in perspective.
In a letter dated December 11th, Consumers Union writes, "Studies show significant injury, morbidity and mortality following implant surgeries." The group offered its own data to back up the claim, referencing a survey of Consumer Reports subscribers who had joint replacement surgeries; respondents reported a 5% infection rate. They acknowledged that the data was self-reported, which made it impossible to confirm the infection or know what type of infection occurred, but the 5% rate is higher than reported in some studies. In contrast, a published study on TKRs in California between 1991 and 2001 was also cited in the letter. That study showed a 0.53% mortality rate, a 0.71% infection rate, and a 0.41% risk of pulmonary emboli in patients receiving TKR - much lower rates than Consumers Union found, a disparity which is likely to be due at least partially to the Consumers Union survey not being a controlled study. Still, Consumers Union is striving to make these statistics a bigger part of how devices are advertised. The letter praises Biomet for including a risks page for their products, but points out that in a video about a hip replacement featuring Mary Lou Retton, warnings about infection and the potential severity of side effects were excluded.
As a solution, Consumers Union argues that warnings about the dangers of a device should be more visible in marketing. The group recommends that all DTC ads be required to contain a warning to the effect of, "“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.”
Do these warnings help inform patients or serve as a scare tactic? Some argue that the warnings, beyond just reminding patients that any surgical procedures comes with risk, could have a disproportionately negative effect. As the Wall Street Journal pointed out in op-ed yesterday morning discussing device risk (subscription required) and public perception of that risk, some patients may decide not to undergo surgery for an implantable device for fear of the side effects. This can, ironically, further compromise the person's health. For some patients, the piece's author writes, "Not having a device is far worse for them than the possibility of malfunction." Disclosure of possible complications and adverse effects is key to patients making informed decisions about their care, but DTC caveats are no substitute for physician's role in both mitigating a patient's fears about surgery and choosing appropriate products for a given case.
