Duchesnay Correct Violation: No Apology

Canadian pharmaceutical company, Duchesnay, who market and manufacture the controversial morning sickness pill Diclegis, have corrected a violation, earlier flagged by the American drug administration (FDA).

In a bizarre twist, to the uneducated eye, it looks as if socialite, Kim Kardashian, is making the changes. Let's compare the two posts by Kardashian (none of which mention that she has been paid by Duchesnay to endorse it's morning sickness pill.)

Kardashian's original advert for Diclegis

The FDA, after reviewing the one-sided ad, told Kardashian to remove it and also wrote a warning letter to Duchesnay. The FDA letter warned Duchesnay that they were violating certain rules as they didn't include the risks surrounding Diclegis.

Here's how the ad looks today...

The 2nd (corrective ad) features more text than the original. I think only a person from the planet Zog would believe that it was written by Kardashian.

Duchesnay have confirmed, more or less, that they have corrected their original mistake by proxy, via their Twitter account.

They have also issued a press release via their website here.


To date, no apology has been made by either Kardashian or Duchesnay for violating FDA rules and for potentially duping millions of future consumers of Diclegis.

Back stories regarding Diclegis and the whole Kardashian debacle are below.


Bob Fiddaman




Kim Kardashian on the Pharma Payroll

When Pharma Use the Defence of the FDA

Diclectin and the Redacted Adverse Events

Is It Just Kim Kardashian on the Duchesnay Payroll?

Duchesnay's Payments to Bendectin "Expert"

The Duchesnay and FDA Runaround

The Duchesnay and FDA Runaround

As some of you may know, I became intrigued by the whole Kim Kardashian promotion of Diclegis on her Instagram account a number of weeks ago. My interest peaked when Diclegis manufacturer, Duchesnay employee, Danny Martel, wrote me on Twitter, basically telling me to "educate myself." (Back story)

If you're up to speed on the whole Kardashian promotion you'll know that recently the FDA became involved. They told Kardashian to remove the advertisement and wrote to Duchesnay to inform them that they had violated certain rules in as much that they cannot advertise the benefits of a product without listing the risks of the said drug. The letter, addressed to Eric Gervais, Executive Vice President Duchesnay, Inc. can be viewed here.

Bravo to the FDA for monitoring social networks.

Here's where is gets a tad worrying.

The FDA gave Duchesnay until August 21 to respond to the warning letter, they wrote...

OPDP requests that Duchesnay immediately cease misbranding DICLEGIS and/or cease introducing the misbranded drug into interstate commerce. Please submit a written response to this letter on or before August 21, 2015, stating whether you intend to comply with this request, listing all promotional materials (with the 2253 submission date) for DICLEGIS that contain presentations such as those described above, and explaining your plan for discontinuing use of such materials, or, in the alternative, for ceasing distribution of DICLEGIS. 

Well, we are three days over the deadline and still I see nothing on either the FDA or Duchesnay websites that suggest that a response has been made - so, I wrote to the FDA, who told me that they  "are  not able to comment on an ongoing compliance action, as this information may be privileged confidential information. I’d recommend asking the company if they would be open to sharing information with you."

So, I wrote to Duchesnay and asked them the following...

I am writing to ask if Duchesnay are prepared to share their letter of response they wrote to the FDA regarding the Diclegis promotion (Kim Kardashian) warning letter.
I have wrote directly to the FDA who, in turn, suggested I write directly to you.
Sincerely,

Duchesnay's response is bizarre, to say the least...

Bob,
We will share information once it is publicly available. We do not have that information at this time. 

Share the information when it's publicly available?

Um, I'm not nitpicking but shouldn't it be Duchesnay making this information public? I mean, what, or who are they waiting for?

The last paragraph of the warning letter sent to Duchesnay reads...

Failure to correct the violations discussed above may result in FDA regulatory action, including seizure or injunction, without further notice. 

I think it's fair to say that this is a matter of public interest. Something which I pointed out to the FDA who then went on to tell me...

You could submit a Freedom of Information Act request. FDA Office of Media Affairs does not process FOIA requests. 

Seems a kinda half-arsed way to get an answer to a pretty simple question.


Bob Fiddaman.

Back Stories

Kim Kardashian on the Pharma Payroll

When Pharma Use the Defence of the FDA

Diclectin and the Redacted Adverse Events

Is It Just Kim Kardashian on the Duchesnay Payroll?

Duchesnay's Payments to Bendectin "Expert"

The Dirty Duchesnay Diclegis Promotion...Rumbled

Well, it appears the FDA do have teeth after all, well much bigger fangs than their British and Canadian counterparts the MHRA and Health Canada.

The American medicine regulator has fired off a warning letter to Duchesnay, the Canadian based pharmaceutical company, who recently hired the services of  socialite, and model. Kim Kardashian. It's unknown how much Kardashian was paid by Duchesnay to promote their morning sickness pill, Diclegis to her 47 million social media followers.

The FDA, in a letter to Duchesnay's Executive Vice President, Eric Gervais, have come down hard and highlighted a number of violations.

• The social media post is false or misleading in that it presents efficacy claims for DICLEGIS, but fails to communicate any risk information associated with its use and it omits material facts. 
• The social media post misbrands DICLEGIS within the meaning o the Federal Food, Drug, and Cosmetic Act (FD&C Act) and makes its distribution violative. 
• These violations are concerning from a public health perspective because they suggest that DICLEGIS is safer than has been demonstrated. 

The warning letter goes on to say that The Office of Prescription Drug Promotion (OPDP) expressed concerns regarding violative promotional activities for DICLEGIS as recently as November 2013.

On November 12, 2013, OPDP sent Duchesnay an Untitled Letter regarding a letter announcing the approval of DICLEGIS. The letter cited in the Untitled Letter was false or misleading because, among other concerns, it omitted all risk information and omitted material facts regarding DICLEGIS’ important limitation of use. OPDP is concerned that Duchesnay is continuing to promote DICLEGIS in a violative manner. 

The OPDP have now requested, according to the warning letter, that Duchesnay " immediately cease misbranding DICLEGIS and/or cease introducing the misbranded drug into interstate commerce." They have also requested that Duchesnay, " submit a written response to this letter on or before August 21, 2015, stating whether you intend to comply with this request, listing all promotional materials (with the 2253 submission date) for DICLEGIS that contain presentations such as those described above, and explaining your plan for discontinuing use of such materials, or, in the alternative, for ceasing distribution of DICLEGIS. "

It only seems like yesterday that Duchesnay's Market Analyst, Danny Martel. wrote me on Twitter and told me to "educate myself" regarding Duchesnay's Diclegis. This coming after my first post about the Kardashian controversy (links below)

Good to see the FDA showing their teeth and it will be interesting to see the grovelling letter of apology Duchesnay now make to the FDA.

The FDA Warning letter to Duchesnay can be downloaded here.


Bob Fiddaman

Back Stories.

Kim Kardashian on the Pharma Payroll

When Pharma Use the Defence of the FDA

Diclectin and the Redacted Adverse Events

Is It Just Kim Kardashian on the Duchesnay Payroll?

Duchesnay's Payments to Bendectin "Expert"

Duchesnay's Payments to Bendectin "Expert"

Duchesnay, who have recently been in the news regarding Kim Kardashian's promotion of their morning sickness pill, Diclegis, have, it appears, been paying a number of doctors in the US for "food and beverages", "travel and lodging", "education", "consulting fees" and "Compensation for services other than consulting, including serving as faculty or as a speaker at a venue other than a continuing education program."

The list of payments made to doctors comes from the Open Payments Database and top of the list is Dr. Ralph Webster Hale, who, in 2014, received  $32,875 from Duchesnay. In 2013 Hale, who is based out of Oak Hill, VA, received $27,840 from Duchesnay, rounding up his total to a whopping $60,715. This, it should be pointed out, is standard practice for pharmaceutical companies. They claim they are paying experts to offer safety and efficacy advice whilst advocates, such as myself, suggest that the payments may be to influence other doctors to use certain drugs.

I became increasingly concerned as I went through the list of doctors Duchesnay had paid over a two year period (2013/14)

If you've been following the recent Diclegis posts of mine you'll know that back in the 80's a birth defect lawsuit was filed. The drug in question was called Bendectin, which is, in essence, the same chemical compound that is found in Duchesnay's Diclegis. The lawsuit (Blum vs Merrell Dow) lasted a number of years - on two separate occasions the Blum family (whose son had been born with clubbed feet) were victorious only to have Merrell Dow appeal against the decisions. In the end, Merrell Dow, after lengthy legal jargon that opposed the Jury's findings, were successful and the Blum family were left with nothing. (Relevant links are at the foot of this post)

One of Merrell Dow's experts was Dr Steven Lamm. He examined all of the information on hand and pooled the data (with regard to the sales of Bendectin and its correlation to birth defects) to reach his decision that women who take Bendectin are not at an increased risk of having children with any congenital malformations. In his affidavit, Lamm stated that no published report confirmed Bendectin caused teratogenic effects in humans.

Lamm even wrote a published paper regarding the safety of Bendectin. Entitled. "The Epidemiological Assessment of the Safety and Efficacy of Bendectin", Lamm found that...

...there was no association between Bendectin use and birth in toto, nor was there any association between Bendectin use and birth defects by organ system. Furthermore, analysis of nationwide data showed no change in the birth defect prevalence rates for any birth defect after the sales of Bendectin significantly decreased in 1980 and subsequent years."

Anyway, that was then and this is now...

Duchesnay, between the years of 2013 and 2014 paid Dr. Lamm  $3,500 for "Compensation for services other than consulting, including serving as faculty or as a speaker at a venue other than a continuing education program." and a further $1,823 for "travel and lodging." (Fig 1)  In 2013, Lamm was paid a total of $2,300.

So, let's gets his straight. An expert who gave evidence on behalf of Merrell Dow, that evidence being that their drug Bendectin (which has the same chemical compound as Duchesnay's Diclegis) did not show an increased risk of having children with any congenital malformations, is now being paid by Duchesnay.

Exactly what is  "Compensation for services other than consulting, including serving as faculty or as a speaker at a venue other than a continuing education program."? Who knows? Maybe Duchesnay hired Lamm's services to double check everything and to make sure that Diclegis cannot cause birth defects.

Now, I know that pharmaceutical companies, such as Duchesnay, can hire whoever they want to to give discussions to other doctors, if indeed that's what they hired Lamm for. I do, however, find it odd that an expert for Merrell Dow is now receiving payments from the very same company who have made efforts, I believe,  to belittle the birth defect lawsuits filed all those years ago.

The website bendectin.com, in my opinion, makes every effort to play down the risk of birth defects associated with Bendectin. No surprise, then, when we learn that the website is sponsored by Duchesnay Inc. (Scroll to bottom)

Duchesnay, however, do cover themselves with the disclaimer on the website...

Bendectin.com is intended for general informational purposes only and consists primarily of generally accepted conclusions regarding the history of Bendectin. The content provided in this Site is general in nature and not individually tailored to any particular facts or needs. Duchesnay Inc. is not offering any legal advice, other professional advice or services by providing this information. Bendectin.com should not be relied upon or used as a substitute for consultation with professional legal or other competent advisers.

Fig 1 - Dr. Lamm's $1,823 for "Travel and Lodging" expenses paid by Duchesnay in 2014

I think if any future litigation should arise regarding Diclegis then Duchesnay would find it very difficult to call Lamm as a witness for them given that he has a financial association with them. I think it would be deemed as a conflict of interest.

Doctor Lamm received his master's and doctor of medicine degrees from the University of Southern California. He has served as a consultant in birth-defect epidemiology for the National Center for Health Statistics and has published numerous articles on the magnitude of risk from exposure to various chemical and biological substances.

The Duchesnay Dollars For Docs Database can be accessed here.

The above information and information contained in the links below have been passed on to an investigative journalist. For now, I'm putting Diclegis to sleep.

Bob Fiddaman.

Back Stories.

Kim Kardashian on the Pharma Payroll

When Pharma Use the Defence of the FDA

Diclectin and the Redacted Adverse Events

Is It Just Kim Kardashian on the Duchesnay Payroll?

Is It Just Kim Kardashian on the Duchesnay Payroll?

Astroturfing

The practice of masking the sponsors of a message or organization (e.g., political, advertising, religious or public relations) to make it appear as though it originates from and is supported by grassroots participant(s).

Earlier this week celebrity Kim Kardashian stirred the hornets next via her Instagram account by posting a photo of herself clutching a bottle of morning sickness pills. The pills, Diclegis, (known as Diclectin in Canada) are manufactured by Duchesnay Inc, a pharmaceutical company based in Canada. Duchesnay also have a HQ in the US.

I became interested in this, not so much because Kardashian was promoting a pharmaceutical product but more so because Danny Martel, who is a market analyst for Duchesnay, challenged me on Twitter with a series of tweets telling me to 'educate myself' (Back Story)

Well, throw a dog a bone...

During the past 48 hours or so I have been 'educating myself' and have found something quite interesting.

Duchesnay's American website have a list of "Expectant Mother Resources". Let's just take a look at some of them.

American Pregnancy Association, a national health organization committed to promoting reproductive and pregnancy wellness through education,  support, advocacy, and community awareness.

One of their sponsors/supporters is, it appears, Duchesnay, as you can see from the list of "Education Supporters" (Fig 1) it appears that Duchesnay and the American Pregnancy Association prefer the logo of the brand rather than the company. (second logo in pic)

Fig 1

BabyZone (Now called 'Babble) - The website is broken into categories and is associated with Disney. No information of any sponsoring or funding but an interesting post appears in the 'Pregnancy' section of the website. The post, entitled, "The Only Drug You Should Take for Morning Sickness -- And It Isn't Zofran", was written by Aela Mass. Aela writes...

"But that doesn’t mean you have to suffer from severe morning sickness; there is a drug approved by the FDA to take so you don’t have to spend your days hugging the toilet bowl.

"Diclegis.

"As the article states, Diclegis is not only approved for use during pregnancy, but it is also the only drug that has been “studied in hundreds of thousands of pregnant women and is a pregnancy category A drug there is now a safer option for women” suffering from morning sickness."

Her article invoked quite a response from people who were suggesting that Zofran worked for them. Zofran is, incidentally, the subject of a birth defect lawsuit in the US. Diclegis, under a different brand name and manufacturer, has also been the subject of a birth defect lawsuit.

It's difficult to say if BabyZone (Now called 'Babble) have associations with Diclegis manufacturer, Duchesnay, and I'm not insinuating that they do. The article, however, does smack of pharmaceutical tactics in as much that it highlights one drug that is unsafe whilst bigging up another drug that is apparently safe. GlaxoSmithKline did pretty much the same thing with Paxil. When promoting it to doctors via their reps they would often highlight how bad Prozac was and how good Paxil was. They did this via reps and strategically placed news articles similar to the one above.

"My child is deformed. I took no other medicine. My husband and I have no genetic history of any problems."

Everyday Health, whose portfolio includes websites, mobile applications and social media assets, designed to provide consumers and healthcare professionals with access to the most trusted health and wellness content tailored to meet their daily needs.

I'm including Everyday Health for the simple reason that they allow reviews of drugs on their website. The reviews for Duchesnay's Diclegis are quite telling. In all there are four consumer reviews averaging 1.5 out of 5. One in particular is quite revealing (Fig 2)

Fig 2

MorningSicknessUSA.com, is a website that, at first glance, looks like a resource for morning sickness. That is until you scroll down to the bottom and read the small print. (Fig 3)

Fig 3

What to Expect, is a website filled with the latest in pregnancy and parenting information and news.

There is no evidence of funding from Duchesnay on this website but I'm including them as they include a post about Diclegis that says, "The good news is that there's now an FDA-approved drug called Diclegis that can treat the symptoms of NVP, or Nausea and Vomiting in Pregnancy. Your doctor will likely prescribe you to take two tablets daily at bedtime. If your symptoms persist, your doctor may then up your dose to a maximum of four tablets daily."

The article credits no particular author and I'm not suggesting that this is a case of product placement. Only in litigation do we ever get to see evidence that points to ghostwritten or product placement articles funded by pharmaceutical companies.


MotherToBaby.org (formally known as Organization of Teratology Information Specialists)

They have a section on Diclegis entitled, Non-Profit Answers Questions About New Drug Aimed At Treating Nausea And Vomiting In Pregnancy.

Experts at MotherToBaby, the counseling service branch of the non-profit Organization of Teratology Information Specialists (OTIS), said NVP affects nearly 80% of pregnant women, usually in their first trimester. A smaller proportion of women develop hyperemesis gravidarum, a much more severe form of NVP. A pregnant woman who develops hyperemesis gravidarum, may potentially deliver a smaller baby. “Babies who are born at a lower birth weight can be predisposed to other complications,” explained Robert Felix, a senior teratogen information specialist for MotherToBaby’s California affiliate at the University of California, San Diego. “Diclegis might help to possibly curb that result.”

They even have a Toll number - Those with questions about Diclegis or other medications during pregnancy and breastfeeding are encouraged to call MotherToBaby experts toll-FREE at 866-626-6847 or by visiting MotherToBaby.org.

As a non-profit private corporation, OTIS’ MotherToBaby service receives funding from a number of different sources including, amongst many other pharmaceutical companies, Duchesnay. (Source)


Moving away from Duchesnay's own website reveals more collaborations.

The Star Canada, revealed in April this year that Duchesnay, has a financial relationship with Sick Kids’ Motherisk program and the Society of Obstetricians and Gynaecologists of Canada.

The Star writes...

"In the latest Sick Kids Foundation annual report, Duchesnay is included on a list of donors that gave between $1 million and $5 million between April 1, 1993, and March 31, 2014."

Today sees the Sick Kids: Motherisk website proudly boast the following (Fig 4)

Fig 4

Meantime, the Society of Obstetricians and Gynaecologists of Canada told The Star...

"...the society’s relationship with its sponsors as “unbiased,” and stressed that all of these relationships “are bound by strict policies to mitigate conflict of interest and adhere to all (Canadian Medical Association) guidelines."

Just last month Duchesnay was one of the sponsors at the American College of Nurse-Midwives 58th Annual Meeting & Exhibition. A Breakfast Symposium, sponsored by Duchesnay USA, was presented on June 1 where Nausea and Vomiting in Pregnancy was discussed. The two speakers were Elaine Mielcarski and Andre Lalonde, MD.

Mielcarski is a a gynecologic nurse practitioner and a licensed midwife, whilst Lalonde was, or still is executive vice president of the Society of Obstetricians and Gynaecologists of Canada. Make of that what you will.




It seems Duchesnay may have shot themselves in the feet when hiring Kim Kardashian to promote their morning sickness pill. Kardashian, for one reason or another, isn't really liked by many people - I can't really comment as I really don't know enough about her other than she seems to be famous for knowing the famous.I don't think there would have been such a backlash had they have hired someone with a wider appeal, say Jane Fonda or Shania Twain for example. Maybe Duchesnay did approach other celebrities but were turned down or maybe they approached Kardashian because she is currently pregnant. (Fig 5) I'd really like to know if Kardashian actually uses Diclegis or just endorses it. Given the controversy of the compounds that make up Diclegis, I do hope that Kardashian has a healthy baby.

Fig 5

There's a small twist of irony here too. If Duchesnay's market analyst, Danny Martel, hadn't have told me (numerous times) to educate myself then I probably would have dropped this as it's not a drug used to treat depression (which are the drugs that I normally write about)

So, I've educated myself thanks to the request of someone who works for, or is associated with Duchesnay.

Call it bittersweet irony, if you will.


Bob Fiddaman.


Back Stories


Kim Kardashian on the Pharma Payroll

When Pharma Use the Defence of the FDA

Diclectin and the Redacted Adverse Events