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Misleading Advertising of Osteoporosis Drugs

The following is taken from an FDA warning letter issued to Lilly on Sept 14, 2000 concerning a "broadcast"/"disseminated" (presumably TV) ad. I have replaced the brand name in the first part by "X" because the FDA's objections can be equally applied to similar implications in many ads for various "osteoporosis" drugs targeted at menopausal women. However I've left the drug name as Evista in the latter half since the objections are specific to its marketing at the time.

The whole document (which is a .pdf file) is accessible through http://www.fda.gov/cder/warn/warn2000.htm
 
DDMAC has reviewed this disseminated advertisement and has determined that it is in violation of the Federal Food, Drug, and Cosmetic Act and its implementing regulations. Specifically, we object for the following reasons:

 Overstatement of Benefit
 The advertisement is misleading because it mischaracterizes the nature of osteoporosis, resulting in an overstatement of X's benefits.

 For example, claims such as “A disease of thin, weak bones that can fracture and take away your independence” and “Don’t let osteoporosis stop you” misleadingly imply that having osteoporosis is, in itself, debilitating. However, while osteoporosis increases the risk of fracture, not every osteoporotic patient will suffer a fracture. In addition, those who do will not necessarily suffer any loss of independence because many osteoporotic fractures are asymptomatic. Furthermore, while X may reduce the risk of fracture, it does not eliminate it altogether therefore these claims misleadinglv imply outcomes and guarantees of efficacy for X that have not been demonstrated by substantial evidence.

  Similarly, the claim “Up to 1/2 of women over 50 will break a bone due to osteoporosis” is misleading because it lacks context that distinguishes between symptomatic fractures of the hip or wrist and asymptomatic vertebral fractures. Vertebral fractures are the most common type of osteoporotic fractures in postmenopausal women. Yet, most vertebral fractures are not symptomatic and do not interfere with a patient’s independence. <snip> Therefore, this presentation misleadingly suggests that X provides greater efficacy than demonstrated by substantial evidence.

 Broadening of the Patient Population
  The advertisement is misleading because it implies that X is useful for a broader population than that for which it is indicated. For example, the claim “if you’re past menopause you should know about X" creates a misleading impression that all  postmenopausal women will develop osteoporosis. However, menopause alone does not cause osteoporosis and only those with risk factors are candidates for X therapy. Thus, the claim misleadingly overstates the population appropriate for X therapy by implying that all women will develop osteoporosis at menopause.

Inadequate risk disclosure
The PI contains a  precaution that concomitant use of Evista with systemic estrogens is not recommended. Because a significant number of postmenopausal women use estrogen replacement therapy, failure to disclose this information in this broadcast advertisement misleading implies that Evista is safer than has been demonstrated.. 

In addition, the presentation of adverse events information is misleading because the phrase "most women do not experience these" minimizes the incidence of side effects associated with Evista therapy. For example, hot flashes occured in 24.6% of the women who received Evista during the prevention trials. the presentation of this phrase without accompanying contextual information is misleading because it minimizes the importance of this adverse event that occurs in a significant percentage of patients.

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