Kim Kardashian drug endorsement may break Canadian law: experts

Kim Kardashian’s latest advertising deal not only made a splash among her nearly 42 million Instagram followers, it may also have contravened Canada’s direct-to-consumer drug advertising laws.

Two weeks ago, Kardashian posted a photo of herself to the social media site holding a small white bottle of pills. Diclegis — known as Diclectin in Canada — is made by Montreal-based Duchesnay Inc. and is the world’s most prescribed morning sickness drug used to treat nausea and vomiting during pregnancy.

“OMG. Have you heard about this? As you guys know my #morningsickness has been pretty bad. I tried changing things about my lifestyle, like my diet, but nothing helped, so I talked to my doctor. He prescribed me #Diclegis, I felt a lot better and most importantly, it’s been studied and there was no increased risk to the baby…”

Kardashian writes that she’s partnered with Duchesnay USA to help “raise awareness about treating morning sickness,” and urges her followers to ask their doctor about “the pill with the pregnant woman on it.”

“It’s hard to imagine a more clear violation of Canadian law,” says Matthew Herder, associate professor in the faculties of Medicine and Law at Dalhousie University. “In this country so-called ‘reminder ads’ — where a drug is named, but its purpose isn’t — are technically legal. But ads that mention both the drug and its purpose are illegal. That’s what the Kardashian Instagram post does: it says the drug name and says what it’s for. So it’s hard to see how this doesn’t run afoul of Canadian law.”

Tim Caulfield, Canada Chair for Health Law and Policy at the University of Alberta and author of the recently published Is Gwyneth Paltrow Wrong About Everything?: When Celebrity Culture and Science Clash, agrees.

“From the direct-to-consumer advertising perspective, I don’t know how this will fit with existing regulations, not just in Canada but around the world,” he says. “Really only the U.S. and New Zealand allow direct-to-consumer drug advertising.”

“It’s a logical evolution to see social media used as a marketing tool, so I’m not surprised,” adds Caulfield. “It will be interesting to see how Health Canada responds. There has already been some concern that they don’t fully [enforce] the ban; there are some things they let through. This whole situation highlights, at a minimum, the need for more clarity.”

Diclectin, which has been prescribed in Canada since 1983, is the only drug approved by the U.S. Food and Drug Administration (FDA) to treat nausea and vomiting in pregnancy.

A time-release tablet made up of Vitamin B6 and an antihistamine called doxylamine, it was approved for sale in the U.S. under the name Diclegis in April 2013. Not long after, Duchesnay USA received a warning from the FDA for failing to include any risk information in a letter about the drug sent to doctors.

The pharmaceutical maker has also seen some bad press at home. In April, the Toronto Star published an investigative feature outlining Dr. Nav Persaud’s three-and-a-half year battle with Duchesnay Inc. and Health Canada for basic clinical information on the drug.

The largest study done that supports the use of Diclectin in pregnancy was published in 1997 and co-authored by Dr. Gideon Koren, the founder of SickKids’ Motherisk.

In 2013, Dr. Persaud published a re-analysis of the Motherisk trial that called into question some of the study’s findings.

Ray Chepesiuk, commissioner of the Pharmaceutical Advertising Advisory Board, told the National Post that Health Canada should get involved, and that he believes Duchesnay Inc. is indeed infringing on Canadian regulations.

Professor Herder says, “I hope current law gets enforced in this case and, as part and parcel of doing so, all the information the Canadian regulator has about Diclectin’s safety and effectiveness should be made public. In the medium to longer term, a fundamental rethink of how we regulate pharmaceutical advertising is needed.”

When contacted, a spokesman from Health Canada promised to look into the issue and respond via email. At the time of posting, no information had yet been received.

A spokeswoman from Duchesnay USA said the company was not prepared to comment on non-U.S. direct-to-consumer prescription-drug advertising laws, and Duchesnay Inc. spokeswoman also declined to speak with Yahoo Canada News.