Medical device makers get an earful about DTC
Do medical device ads mean that patients are going to run into their doctor demanding hip and knee replacement? Of course not but for consumers who don't do their research the realities of this type of surgery could be soubering. I know of at least 2 people who have had knee replacement in their 40's and both said that the recovery was a lot longer and a lot more painful than they had realized even though their doctor gave them materials to read at home. Should the same rules that apply to DTC ads for drugs apply to medical devices?
Here is what Dr Bozick has to say about that:
Although the effects of DTCA related to drugs have been studied extensively, there are substantial differences between DTCA related to pharmaceutical products and medical devices which make extrapolating the findings or conclusions inappropriate and misleading. First, there is a substantial difference in price between medical devices and prescription drugs. Second, medical devices are usually sold to hospitals, although surgeons are the primary decision makers and end users. Unlike prescription drugs, early adopters of new medical technologies, including physicians and hospitals, often promote their use of these technologies in an attempt to differentiate themselves in a competitive marketplace to attract patients who seek treatment from “high tech” or “cutting-edge” providers. However, when a surgeon decides to use a new device in their practice, additional training is often recommended, and there is a learning curve effect that can be associated with a higher rate of complications. Finally, the potential adverse consequences to the patient and the surgeon are considerable if an inappropriate or unfamiliar device or surgical technique is used, the choice of implant or procedure cannot be easily substituted if the result of surgery is unfavorable.
DTCA of devices may not inform patients about the differences in product design, composition of materials, strength of the devices, or proper clinical indications. Potential patients may not have access to post-market surveillance data or understand issues relating to device performance and safety. Surgeons choose devices to meet an individual patient’s needs. For example, implant wear is a significant issue with devices used by orthopaedic surgeons. Patients may not be aware of the appropriateness of certain devices for their particular health conditions or health status.
Now we are not going to go into the kickbacks that some medical device makers were giving thought leaders who recommended medical devices to other physicians or that certain medical device makers are under intense scrutiny and have hired counsel but to an aging population that often feels instant gratification takes too long a hip or knee replacement may seem like a "quick fix" when there are a lot of factors to consider before considering such surgery.
Dr Bozick goes on to say:
The practice of marketing medical devices directly to the consumer rather than to the physician has become the subject of significant debate. Many advertisements are incomprehensible to the American public, which studies have shown on average read at an eighth grade reading level.13
Most information, particularly in print advertisements, is edited from the FDA approved labeling requirements targeted to health care professionals. Side effects and risk information are often formatted on the back of a print advertisement and are therefore, generally neglected by readers. Additionally, the font size of the print advertisement is significantly smaller when conveying risk information as opposed to the benefit information. Smaller font size is particularly difficult for seniors to read as their vision becomes less acute during the aging process.
.The lack of fair balance in describing benefit and risk information in advertising is problematic. Potential benefit information is typically presented in layman’s terms whereas risk information is downplayed by using medical jargon, using a very small font size, or increasing the speed of delivery of information in a voice-over announcement. Therefore, risk information is often not read, not comprehended, nor sometimes even reasonably visible
When I read this the word "transparency" came to mind. Yes Dr Bozick is right about fair balance but does he really believe that people are going to read an ad and then go into their doctors to ask for a hip or knee replacement? That is not going to happen. What is going to happen is that people are going to research this treatment on the Web especially in social media boards. I went to a board and there were tons of stories, some good some bad, about knee and hip replacement. The reality is that the physician does not have time to sit with a patient and explain everything to them. A great first step however would be to require that fair balance, in plain English, be on all medical device ads.