Monitoring The Truth In Medical Advertising

During my career, I have had the opportunity to work as a consultant to several footwear companies that market and advertise products directly to the consumer. Currently, I own a company that markets ankle-foot orthoses (AFOs) to healthcare professionals. This experience has taught me that until recently, there has been a clear difference in the standards maintained by companies that market to the consumer and those that market to medical professionals.

It was always disappointing if not frustrating to see many athletic footwear companies advertise to consumers product benefits that had no validity. Previously, it seemed as if there were no watchdogs looking over that industry to protect the consumer from false and misleading advertising. It is refreshing to see this trend reversing as Skechers had to pay a $40 million settlement in a class action suit by consumers who had been misled by advertising that promised fitness benefits that the product could never achieve.1

Companies that market pharmaceutical products must adhere to strict guidelines from the Food and Drug Administration (FDA) to accurately report scientific facts in advertising their products.2 Companies that market medical devices are not under as strict control but have traditionally followed unwritten guidelines that ensure valid presentation of features and benefits of the products and avoid sensational promises about treatment outcomes. It has always been refreshing to see a certain commitment to a high standard of ethics from the vast majority of companies that market products to the podiatric profession.

Unfortunately, that trend has changed over recent years as companies now market products to our profession promising unfounded and unachievable benefits to our patients. The companies that violate previous ethical standards are marketing products ranging from dermatological cures to surgical devices. Several borrow a common claim seen in the consumer marketplace that a product is “clinically proven.”

For example, a company currently advertises an AFO stating that the device is a “clinically proven treatment modality, which effectively reduces falls risk in the elderly.” Simple examination of the advertisement reveals that it cites a study that is not a clinical study and did not in any way measure a reduced risk of falling in the study subjects. Any intervention that could make the bold claim that it is “clinically proven” to prevent falls risk would, according to established standards, have multiple Level 1 studies to back up such a groundbreaking claim.

Happily, the term “clinically proven” rarely appears in advertising in our trade publications. Companies that use this term fail to give respect to the readers who clearly know that it is commonly used to dupe consumers into thinking that a product has valid benefit. As trained podiatric physicians, I think we all know better.

References
1. Available at http://www.skecherssettlement.com/ . Published July 12, 2013. Accessed April 17, 2014.
2. Available at http://www.fda.gov/Drugs/ResourcesForYou/Consumers/PrescriptionDrugAdver... . Published Sept. 13, 2012. Accessed April 17, 2014.



Robertsays: April 21, 2014 at 9:04 pm

Excellent post Doug. Our practice was approached regarding these fall prevention braces (aka "balance braces"). We kept asking about the legitimacy of billing for this type of brace and the rep kept talking in circles. We did a little investigating with Medicare and it turns out that there is no approval for a fall prevention or balance brace. So the strong implication was that although the product was being marketed as a balance/fall prevention brace, it couldn't really be billed that way. In order to receive payment for this AFO, we would have to bill some other musculoskeletal diagnosis, but NOT fall prevention, etc. So it almost seemed as if it were bait and switch. Discuss or advertise the brace as a fall prevention/balance brace but bill it as a brace being used for some other musculoskeletal issue. This didn't sit well with us so we passed on the use of this product. We also asked for some EBM or significant studies but none were supplied. So I completely understand your comments.

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