MORN­ING SICK­NESS PILL EN­DORSED BY KIM NOT PROP­ERLY TESTED

The Star Early Edition - - VERVE -

IN 2015, a preg­nant Kim Kar­dashian posted an un­usual In­sta­gram photo of her­self hold­ing a bot­tle of pills.

“OMG,” she wrote in the cap­tion. “Have you heard about this? As you guys know my #morn­ingsick­ness has been pretty bad … 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.”

The photo made head­lines when the Food and Drug Ad­min­is­tra­tion cracked down on the drug’s man­u­fac­turer for not dis­clos­ing risks in its mar­ket­ing. Di­clegis is in the news again to­day, but this time it’s not just the ad­ver­tis­ing that’s in ques­tion: It’s the ef­fec­tive­ness of the drug it­self.

For more than 40 years, preg­nant women around the world sought help for morn­ing sick­ness through a com­bi­na­tion of the two main in­gre­di­ents in Di­clegis: pyri­dox­ine and doxy­lamine. About 35 mil­lion are be­lieved to have taken the med­i­ca­tion. Could their faith in the treat­ment be based on flawed data?

That un­set­tling ques­tion is raised by an anal­y­sis pub­lished on Wed­nes­day in PLOS One by re­searchers in Toronto who re­viewed more than 7 200 pages of data from a clin­i­cal trial in the 1970s that had never been made pub­lic be­fore.

Nav Per­saud, a fam­ily physi­cian and re­searcher at St Michael’s Hos­pi­tal who is the main au­thor of the new anal­y­sis, said the trial in ques­tion was key to ob­tain­ing the drug’s ap­proval in Canada, where it is sold as Di­clectin.

The old clin­i­cal trial was con­ducted by Mer­rell-Na­tional Lab­o­ra­to­ries, which no longer ex­ists, and in­volved 2 308 pa­tients at 14 clin­ics in the US who were in the first 12 weeks of preg­nancy who com­plained of nau­sea or vom­it­ing. Women were asked to take two tablets at bed­time and, if nec­es­sary, an­other in the morn­ing and midafter­noon for seven nights. Doc­tors were asked to note the fre­quency of vom­it­ing and hours of nau­sea.

In the med­i­cal lit­er­a­ture over the past few decades, Per­saud said this study, which was never fin­ished, had been re­ferred to as be­ing a suc­cess but with no de­tails.

How­ever, he said, when he looked at the raw data it con­tained crit­i­cal flaws, in­clud­ing the fact that some in­for­ma­tion that was sup­posed to be ob­tained dur­ing pa­tient vis­its was not, and about 30% of the pa­tients were lost to fol­low up de­spite the fact that the trial lasted only a week.

Kim Kar­dashian

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