Kim Kardashian has found a new way to leverage her 42 million Instagram followers: pharmaceutical sales. Last month, Kim posted a picture to her account of herself holding a bottle of Diclegis, an FDA-approved treatment for morning sickness. She included a comment explaining that she “felt a lot better” after using Diclegis to treat her own morning sickness. She went on to note that she was comfortable taking the drug because “it’s been studied and there was no increased risk to the baby.”
Unfortunately for Kim, and Duchesnay, the manufacturer of Diclegis who paid Kim to promote the drug, this doesn’t provide a full description of the safety profile of the drug. Specifically, as the FDA pointed out to Duchesnay in a letter following on Kim’s post, marketing is misleading if it presents efficacy claims but fails to communicate risk information. In the case of Diclegis, Kim failed to mention that Diclegis has not been studied in women with severe morning sickness and side effects include somnolescence. Not mentioned by the FDA, but likely significant to consumers, is the additional fact that Diclegis was pulled from the market in 1983 after a number of lawsuits led to findings it caused birth defects. It was only after Duchasney sponsored a clinical trial proving to the FDA’s satisfaction that the drug did not increase the risk of birth defects that it was allowed back on the market.
There is a debate currently raging in the courts about what limits FDA should be able to place on drug companies’ marketing tactics. For years, through use of the False Claims Act, the Department of Justice has collected multi-million and billion dollar settlements from drug companies based on their “off-label” marketing of drugs – promoting use of their drugs for populations, indications, or in dosages not approved by the FDA. But this behavior was normally paired with the use of dishonest or misleading promotional materials and/or kickbacks to financially induce prescriptions. Now courts are faced with a more complicated question: should drug companies be able to promote their drugs for uses not approved by the FDA if the materials are truthful and non-misleading and there are no financial inducements?
Duchasney could likely have mollified the FDA by more carefully scripting Kim’s post to include risk information. This may have caused the post to lose some of it’s “Kim authenticity,” but Duchasney would still have reached 42 million (likely mostly female of child-bearing age) Instagram users. To put this in perspective, the Republican Presidential debate held earlier this month had just shy of 24 million viewers. Which brings us to our question of the week: should drug companies be allowed to use celebrities to advertise their drugs? Some may argue that with our country’s “cult of celebrity,” the draw of these figures is too powerful to be used responsibly by manufacturers of something as important as prescription medication. Others might say this is just particularly effective commercial promotion. What do you think?
Please let us know why in the comment section below.
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