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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
Overstatement of
Benefit
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
Inadequate risk disclosure
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. |