I've mentioned in the past about celebrities having a duty to highlight unsafe drugs, opposed to promoting them - the latest celebrity to join the pharma payroll is Kim Kardashian.
Okay, I've heard her name mentioned over the years but had to Google her to see if she was an actress or singer. It turns out she's famous for, um, knowing other celebrities.
Her Instagram account has caused quite a stir since she uploaded a photograph of herself clutching a bottle of pills called Diclegis. Her accompanying comment (if, indeed, it was her that wrote it) reads...
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. I’m so excited and happy with my results that I’m partnering with Duchesnay USA to raise awareness about treating morning sickness. If you have morning sickness, be safe and sure to ask your doctor about the pill with the pregnant woman on it and find out more www.diclegis.com; www.DiclegisImportantSafetyInfo.com
What Kardashian fails to mention is that the compounds that make up Diclegis, namely the combination of pyridoxine and doxylamine, were pulled from the market in 1983. Pyridoxine/doxylamine was first marketed in the U.S. in 1956, back then it was branded as Bendectin (Debendox in the UK). It was developed in the mid-1950s by the Wm. S. Merrell Company of Cincinnati, Ohio and was aimed to help with nausea and vomiting during pregnancy.
Wm. S. Merrell Company and the thalidomide link.
This from Betty Mekdeci, who is Executive Director Birth Defect Research for Children.
Merrell filed a new drug application for Bendectin in June 1956. This NDA was approved by the Food and Drug Administration in just 28 days.
In January 1959, the Merrell Company obtained the exclusive rights to market another drug.Thalidomide had been developed by a West German pharmaceutical company. It was rapidly gaining popularity all over Europe as a "safe" sedative. Thalidomide was also included in some 50 over-the-counter products used for everything from colds and flu to the morning sickness of pregnancy.
Four months after obtaining the license for thalidomide from its German manufacturer, Richardson Merrell began testing the drug by distributing 2,528,412 thalidomide tablets to 1,267 private physicians who gave them to 20,000 patients. At the same time these human studies were underway, the company also began animal testing. Although one of the indications for thalidomide was nausea and vomiting of pregnancy, no specific tests were done to look for possible adverse effects to the developing fetus.
Dr. Frances Kelsey was the medical officer at the Food and Drug Administration who was assigned to review Merrell's New Drug Application for thalidomide. She was not fully satisfied with the data that had been submitted on the drug so she proceeded with the review process very cautiously."
The first reports of problems with thalidomide reached the FDA in 1961. A letter in the British Medical Journal warned of a possible toxic hazard with the new sedative involving peripheral neuritis, a serious nervous disorder, in patients who had received the drug for more than six months. This information was enough for Dr. Kelsey to delay her approval of thalidomide's New Drug Application, a decision that was to save untold thousands of American children from tragedy.
As the story of the thalidomide debacle unfolded, the FDA decided to look through its files to see if they had any adverse reactions reported that bore any resemblance to those of the thalidomide side effects. They found four that bore a striking similarity.
- Infant born 1/15/61 Missing left thumb and right thumb. Club foot and heart disorders.
- Infant born 12/22/60. Absence of left arm, some metarsus varus of the left leg, left side of face flattened, both hands missing index fingers, bilateral club foot.
- Infant born 5/10/62 Nasal bone with no )airway. Fibulars missing from both legs, no knee caps or ankle bones, red mark on forehead between eyes.
- Infant died 4/10/62 Atresia of extremities, imperforate anus
All four reports came via mothers who had taken Bendectin during their pregnancies.
(Source - Bendectin - How a Commonly Used Drug Caused Birth Defects - Part One
by Betty Mekdeci Executive Director Birth Defect Research for Children)
In 1983 Bendectin was removed from the market voluntarily by its maker, the Merrell Company.
Skip forward 30 years to 2013. The FDA, in their infinite wisdom, granted a licence to Diclegis, a drug used for the same indication as what Bendectin was. A drug that featured the same compounds as Bendectin, in fact the only difference is that brand name of the drug.
And now, it seems, that Duchesnay Inc, the Canadian based pharmaceutical company who manufacture Diclegis, have employed the services of Kim Kardashian to promote their drug.
Kardashian, isn't short of money so it beggars belief why she would choose to promote this drug. Surely she was given professional advice on this and didn't go into this financial deal blindfolded? Her husband, Kayne West, has recently been in the news for his bizarre behaviour at award ceremonies and for outlandish statements in front of British rock fans who flocked to see him at Glastonbury a couple of weeks ago.
Promoting drugs when you haven't really looked into the history of those drugs is, in my opinion, totally irresponsible, particularly when you have millions of adoring fans, many of whom are women of child bearing years. Duchesnay Inc know an opportunity when they see one.
I doubt if Kardashian will bother to read the thousands of Tweets she has received since promoting a pharmaceutical product. Why would the heavy criticism bother her when she can count the dollars.
To be honest I find these types of celebrities sickening. Kardashian should do the right thing and pull away from Duchesnay Inc - maybe she could then devote her time and celebrity status to a more worthy cause, like supporting the mothers who have given birth to babies with birth defects, or aborted fetuses because of birth defects due to taking prescription medications.
I'm not holding my breath.
Bob Fiddaman.
Related reading
When Pharma Use the Defence of the FDA
Diclectin and the Redacted Adverse Events
Is It Just Kim Kardashian on the Duchesnay Payroll?
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