Glaxo Settle Paxil Birth Defects

Once again GlaxoSmithKline have settled out of court with a mother who claimed that she and other mothers had not been properly warned about the risks of taking Paxil during pregnancy.

The lawsuit, which was filed 9 years ago, has recently seen both parties come to an agreement - ergo the plaintiffs (50 in all) will probably receive around $150,000 each.

Faith Gibson, who was the lead case in the litigation, used Paxil during her pregnancy and her daughter, Leah, (pictured above) was born with a hole in the heart in 2005. Meah, now aged 11, remains particularly susceptible to whichever cold or flu is going around.

Her mother said...

"In general, Meah, now 11, seems to be doing better physically. But the ordeal has affected her mentally as well.

"Any kind of pain she has in her heart or any sort of discomfort she feels in her chest, she feels like it’s something bad going on and that she might have to have surgery again.

"That side of things hasn’t subsided at all. She’s got a nasty scar on her chest to remember it by, so it’s always there."

GlaxoSmithKline said that despite the settlement in principle, it does not admit to any liability or wrongdoing but has agreed to resolve the class action case to avoid the time and expense associated with a trial and subsequent steps in the proceedings.

“We continue to be of the view that the scientific evidence does not establish that exposure to Paxil during pregnancy causes cardiovascular birth defects."

--

We all know different.

See the evidence in links below, evidence that caused a huge embarrasment to both Glaxo and their attorneys, King & Spalding.

Bob Fiddaman.

Ryan, Glaxo's Non-Viable Fetus - Part I

Ryan, Glaxo's Non-Viable Fetus - Part II - The Twists

Glaxo Destroyed Paxil Animal Studies

Nothing new here but this astounding story is in the news once again.

The revelation first aired some years ago in a Paxil birth defect trial (Kilker Vs GSK).

During the trial, the jury saw an exhibit showing minutes from a teleconference for a Paxil project team meeting. Page eight of the minutes stated: "It has already been discovered that raw data from four of the original Ferrosan sponsored toxicology studies conducted at Huntingdon Life Sciences were destroyed by HLS in 1993."

Now, it appears, Glaxo don't want this information rehashed in a current Paxil birth defect trial from the state of Ohio where it is alleged that Kathryn Kiker, after taking the Paxil while pregnant, gave birth to her child, who was born with a ventricular septal defect, a serious heart problem.

Glaxo, as in many cases where they wish to keep the jury misinformed, have claimed that evidence that lab notebooks from 1979 animal studies were destroyed in 1993 should not be heard by the jury, they cite that the claim “grossly distorts the regulatory practices in place at the time” and is “a manufactured controversy” likely to make jurors assume malfeasance.

Glaxo have filed many motions in this current Paxil birth defects case. They don't wish for the jury to see the 2012 plea agreement, in which Glaxo were find a record-breaking $3billion.

I'm surprised that GlaxoSmithKline continue down this road. They have done the same in the current adult Paxil suicide case of Stewart Dolin, ie; they don't want jury members to know anything about their abhorrent history of witholding evidence that shows that Paxil increases the risk of suicidal thinking and completion in both adults and children who take it.

What I find mind-boggling here is that GSK carried out a series of animal studies in animals, those studies, if supportive of their claim that Paxil is safe during pregnancy, would, for them at least, be worth their weight in gold. However, the studies did not show this so what did Glaxo do, well, it appears that they gave the go-ahead for the studies to be destroyed and kept away from public scrutiny. When being faced with a layperson jury hearing this information they claim that, um, it's irrelevant.

I'd just love to know what planet GSK and its defence attorneys are on, wouldn't you?

In any event, the judge heard their motions and denied them, leaving the door open for the jury to deliberate and discuss why Glaxo would not want animal studies in Paxil to be seen, furthermore why they stood by and allowed them to be destroyed.

The case is set to go to trial later next month.

Kiker is represented by Benjamin Anderson of Anderson Law Offices LLC and Bryan Aylstock, James Barger, Bobby Bradford, Roger Cameron and R. Jason Richards of Aylstock Witkin Kreis & Overholtz.

GSK is represented by Andrew Bayman, Halli Cohn and Meredith Redwine of King & Spalding LLP and William Darrell Kloss Jr., Adam Rusnak and Jessica Goldman of Vorys Sater Seymour & Pease LLP.

Bob Fiddaman.



Related stories.

Ryan, Glaxo's Non-Viable Fetus - Part I

Ryan, Glaxo's Non-Viable Fetus - Part II - The Twists

8 Paxil Kids "Suffered Catastrophic Birth Defects"

One news item that appears to have been overlooked by the mainstream media is news coming out of the state of Illinois where a three-justice panel of the Illinois First District Appellate Court denied an appeal from Paxil (Seroxat) manufacturer, GlaxoSmithKline to bring litigation against them to a halt.

Glaxo, without defending that Paxil caused birth defects in these children, had argued that the plaintiffs who lived outside of Illinois should not be able to bring a case against them. (6 of the 8 live outside of Illinois)

Plaintiffs argued that during the illegal promotion of Paxil (ie; GSK reps telling doctors that Paxil was safe in pregnancy) over 17 Paxil-related clinical trials were carried out in Illinois.

Judge Axelrood ruled in plaintiffs favour - Glaxo appealed and that appeal has been turned down by the three-justice panel.

The panel said...

“Defendant GSK conducted a part of its general business in Illinois, and plaintiffs’ claims arose out of the very trials conducted, in part, in Illinois,” the justices wrote. “The fact that the contested plaintiffs are not Illinois residents does not destroy the jurisdiction established on the basis of defendant GSK’s activities here.”

Interestingly, the panel also found that GSK’s sustained business presence in Illinois, including 217 employees who lived in Illinois, including 79-121 employees may have been tasked specifically with marketing Paxil in Illinois.

This, it appears, has become standard fare for GlaxoSmithKline. They no longer deny that Paxil can cause birth defects, they just try to get cases tossed using state laws, when they are denied this they then claim that although Paxil can cause birth defects, any plaintiff who alleges this is either wrong or something else caused the birth defect. They will also, more than likely, delve deep into the mothers history to see if they drank or smoked during their pregnancy. They may also try and damage the reputations of the mothers by trying to find out if they were involved in extra marital affairs during their pregnancies - all this, in efforts not to pay compensation - it's the act of a vulture picking on a dead carcass ~ although, to be honest, I'd rather spend time in a room with a vulture than one of GSK's hired suits.

This from the Cook County Record...

In 2014, eight mothers filed suit against GSK in Cook County Circuit Court, alleging their children “suffered catastrophic birth defects” 

The plaintiffs alleged GSK should have known of the dangers of the drug from its clinical test results, and should have warned doctors and expectant mothers of its allegedly “significantly increased risk of congenital defects in babies whose mothers ingested” Paxil.

Instead, plaintiffs asserted GSK promoted Paxil as “being safe for pregnant women.”

GlaxoSmithKline's company motto, that they still use today, is...

We are dedicated to improving the quality of human life by enabling people to do more, feel better, live longer.

It's a mantra that, I believe, goads victims of GSK.

As a father, myself, I am outraged. If I were a mother I'd be homicidal.

Plaintiffs are represented in the above case by attorneys with the firm of Tor Hoerman Law LLC, of Chicago.

GlaxoSmithKline was defended by the firms of Dentons US LLP and Cozen O’Connor, each of Chicago.


Bob Fiddaman


Related

Ryan, Glaxo's Non-Viable Fetus - Part I

Ryan, Glaxo's Non-Viable Fetus - Part II - The Twists

JANE NIEMAN VIDEO TESTIMONY GSK V KILKER (Paxil Birth Defects)

Paxil Pregnancies in Philidelphia

Imagine the scenario, if you will.

You're in court because you lost your leg in a coach accident. The coach company are defending allegations that they are responsible. Evidence surfaces that the coach you were travelling on had faulty brakes, moreover, the driver of the coach didn't know about the faulty brakes but the coach company did.

Testimony is taken from the driver prior to the trial. He states that if he had known about the faulty brakes on the coach he would not have driven it.

On the day of the trial your legal team wish to present the testimony of the driver. The defence team object and the Judge sides with them.

Days later, as the trial nears completion, the Judge announces that you cannot proceed with your claim against the company because you have no proof that the driver would have taken the bus out that day if he had been warned that it had faulty brakes.

You, your legal team, and all those present in court are stunned into silence at the Judges' rationale because you do have the proof but he won't allow you to present it.

You following?

If the above scenario seems absurd then welcome to the world of Philadelphia.

Back in April  Judge Kenneth Powell halted not one but nine Paxil birth defect cases. The lead case in question involved Braden Rader, who was born with tetralogy of fallot (a combination of several congenital heart defects) that his mother claimed was caused by the use of Paxil during the early stages of her pregnancy in 2003. (Rader et al. v. SmithKlineBeecham Corp. et al.)

Powell ruled that the prescribing physician, Robert Kiehn, had not testified that he would have altered his decision to prescribe Paxil to Rader’s mother, plaintiff Elisabeth Balser, if he had of known about its link to birth defects.

However, Kiehn had already testified in a videotaped deposition that he would not have prescribed Paxil if he had known about the birth defect links but Judge Powell had previously prevented this testimony from being played to the jury.

Obviously, his decision to halt the trial is being appealed and, at present, this trial and 9 others is on "stay" - basically put on hold until a decision is made on the appeal.

GSK's attorneys, as one would expect, have requested to lift the stay, in other words, they have tried to get all of them thrown out by the Judge before a result of the appeal.

In this instance we have a different Judge making the decision. Philadelphia County Court of Common Pleas Judge Arnold New has denied Glaxo's bids to lift a stay on litigation.

The state of Philadelphia is no stranger to cases of Paxil birth defects.

Back in 2014 I wrote about one such case regarding Pennsylvanian mother, Joanne Thomas. (Links at foot of this post) Her case was tossed by the Judge because, according to Glaxo's lawyers, she was too late in filing. In any event, Glaxo argued, her fetus was non-viable (Non viable means not capable of living, growing, or developing and functioning successfully. It is antithesis of viable, which is defined as having attained such form and development of organs as to be normally capable of living outside the uterus.)

Thomas lost her case then, later, lost the appeal. However, all was not lost. Thomas approached me and after many hours, days weeks and months, I contacted her attorneys with evidence to present to the Judge who had denied her appeal.

You see Glaxo's attorneys should have provided Thomas' attorneys with discovery - that discovery would have shown that Glaxo had already admitted (via internal emails) that Thomas' use of Paxil during her pregnancy was probably the cause of her having to abort her fetus due to it developing a whole heap of birth defects.

Thomas eventually made an out of court settlement with GSK and was told by her own attorneys to have no more contact with me. Shucks, hand them a winnable case on a plate and that's the thanks I get!

It's since been suggested that I should have billed the attorneys for the months of hard slog I put in (for free) - Ah well, you live and learn.


In the case of Braden Rader, I guess we'll just have to wait and see how the appeal goes.

(Source) - GlaxoSmithKline Denied Bid To Unpause Philly Paxil Litigation



Bob Fiddaman.


Related

Ryan, Glaxo's Non-Viable Fetus - Part I

Ryan, Glaxo's Non-Viable Fetus - Part II - The Twists

Paxil Birth Defects: GSK Attorney Sinks to New Low

Todd Davis ~ remember the name. Davis is an attorney who has represented GlaxoSmithKline on numerous occasions. He is employed by King & Spalding.

On with the story...

Elisabeth Balzer took Paxil while pregnant. Her son, Braden, was born with tetralogy of fallot (a combination of four heart defects). A  cardiologist expert witness, Dr. Ra-id Abdulla, testified that a review of Braden Rader’s and his mother’s medical records showed that Braden’s heart defects was related to exposure to Paxil during his mother’s pregnancy. Abdulla also pointed out (under cross-examination) that the American Heart Association has already “assessed, documented, and judged” the existence of a causal link between Paxil and heart defects.

Braden has already been through two heart surgeries, one several months after his birth and the second just last year.

A few days later it was the turn of Braden's mother, Elisabeth, to take the stand. Elizabeth began speaking of her emotional response to Braden undergoing open-heart surgery as an infant. Immediately Glaxo's counsel objected, moreover, Todd Davis argued that Balzer did not have valid claims for any pain, suffering or emotional distress she may have had as a result of her son’s injury.

Using Mississippi state law, Davis said, “She didn’t know that the injury happened to Braden. It occurred during the first trimester. There’s no way she could have any physical impact from an injury that she didn’t know had occurred.”

Balzer’s lawyer, James Morris Jr, of Morris Law Firm, responded by saying,  “What could be more shocking or upsetting to a woman than to be advised that your baby has a birth defect? To talk about her as if she was a bystander is ridiculous. This child was inside her when the defect occurred. It was delivered, her own child, with the defect. I’m shocked that that type of argument would even be made. If the appellate courts and the Supreme Court want to go with Mr. Davis’s theory then I really regret where this country is headed.”

The outcome?

Judge Kenneth Powell, who was presiding over matters, sided with GSK's counsel. Powell said, "I will not permit the plaintiff to testify about physical injury or physical manifestations or anything that denotes pain and suffering” in front of the jury."

A week or so later Balzer had her case against GSK dismissed in yet, it has to be said, more bizarre circumstances/ reasons given by Judge Kenneth Powell. Judge Powell found that Dr. Robert Kiehn’s (Elizabeth's prescribing physician) testimony did not include an important detail: that he would have refrained from prescribing Paxil to the pregnant Mrs. Balzer had he been given more adequate warnings of the possible risks.

However, another of Balzer’s lawyers, Adam Peavy of Bailey Peavy Bailey Cowan Heckaman PLLC, disagreed, he said, “To suggest that the question was never asked is not accurate. It was asked multiple times about what he would’ve done with a different warning, or if he was warned about Paxil causing birth defects. Your honor excluded that evidence.”

So, to recap.

Elizabeth Balzer's prescribing physician was asked numerous times during deposition whether or not he would have prescribed Paxil to her had a warning of birth defects being caused by Paxil would have, at the time, been available to him.

Judge Powell excluded this part of the testimony.

Powell then rules in favour of GSK by claiming that there was no evidence to show that Balzer's treating physician would have prescribed her Paxil had he have known about the Paxil birth defect link ~ of course there wasn't any evidence, the Judge himself had, previously in the trial, excluded it from being heard!

Adam Peavy of Bailey Peavy Bailey Cowan Heckaman in Houston, who represented Rader, said he plans to appeal.

This isn't the first time Davis has made claims that people under deposition or on the stand couldn't have "possibly known." In 2007 Davis also tried to use the "Couldn't have known" argument, this time, however, he was protecting Sally K. Laden, a ghostwriter for GSK. Once again, the drug in question was Paxil. (Back story)

Hats off to Todd Davis of King & Spalding. He really earned his corn on this one ~ he used the Mississippi law to Glaxo's advantage.

Hats off too to whatever religious belief Davis follows. It must be wonderful to have a doctrine whereby mothers aren't permitted to show any form of emotion when discussing their child's birth defects. Who knows, maybe Davis is an atheist?

I take it that a Bible was sworn on at some point during these proceedings? I'd just like to know where in the Bible it states that "Thou shalt not show emotions if they are female."

Kudos too to Judge Kenneth Powell who should be awarded with the 'Short-Term Memory of the Year Award.'

Bob Fiddaman.




Sources:

Legal Reader

Law360

The Legal Inteligencer


Related

Ryan, Glaxo's Non-Viable Fetus - Part I

Ryan, Glaxo's Non-Viable Fetus - Part II - The Twists

Birth Defect Ethics, Are They as Simple as Black & White?

Quite often questions come to me, usually at night whilst in bed alone, save for the background music of Hans Zimmer that helps me drift off to sleep.

One such question, invoked another, they both kept me awake for most of the night as I mulled over possible answers, the most obvious answer, of course, would be jail time.

Here's what I was mulling over.

SCENARIO:

A husband and wife have a disagreement over treatment. Mrs Smith has recently been told that she is pregnant, she has also been diagnosed with depression and has been told by her physician that if left untreated it could harm her fetus. Mrs Smith believes the risk of taking antidepressants during pregnancy is too high, she has read stories that they can cause birth defects.

Her husband, Mr Smith, does not believe the risks are that high, he's read many published papers from academics that suggest antidepressant treatment will save the baby from becoming distressed inside the womb and depressed when born.

So, here's the dilemma. It's his child just as much as it is his wife's. They are at loggerheads over the decision to medicate - does the expectant mother have the final say?

This isn't the question that kept me awake.

Mr Smith, decides to treat his wife with antidepressants (without her knowledge... ergo, without her consent)

Every day he crushes two antidepressants into her dinner - he does so because he wants to protect his child from being distressed in the womb or being born depressed. Hey, he's read the literature and believes it to be true.

24 weeks later

Sadly, Mr and Mrs Smith are informed that the fetus has developed defects. Mrs Smith's OBGYN has informed them both that the fetus has developed a number of birth defects, namely; cardiac defects (heart), pulmonary defects (lung), neural-tube defects (brain and spinal cord). Chances of survival, at birth, he informs them, are very slim.

Mrs Smith, along with her husband, decide to abort the fetus, it's a heart-wrenching decision.

Aftermath

Shorty after the termination of his wife's pregnancy, Mr Smith comes clean and tells his wife that he had secretly been administering antidepressants into her food and now believes that the medication may have contributed to the birth defects in their child.

So, here's the two questions...

1. What legal action, if any, could Mrs Smith take against her husband?

2. What defence, if any, could Mr Smith use in a court of Law?

Be interesting to hear/read your comments on this one either via the comments section (below) or via my Twitter account (here) or Facebook Blog account (here)


Bob Fiddaman.


Related:

Prozac: Uncharted Down Syndrome Territory

Prozac: Uncharted Down Syndrome Territory

The University of Texas Southwestern Medical Center have announced new research and planning to see if Prozac (fluoxetine) can improve brain development, intellectual functioning, and behavior of children with Down Syndrome (DS) when given prenatally and postnatally during the first 2 years of life.

According to a breakdown of the study, found here, pregnant women and their unborn child will be assigned randomly to receive either fluoxetine or placebo in the study. Participants will have a 2 in 3 chance of receiving fluoxetine or placebo.


The study suggests...

During the prenatal study period, participants will take their assigned medication orally. After her child is born, the mother will stop taking the oral tablet of her assigned medication and her child will start a liquid solution of the medication to be taken orally. After birth, the fluoxetine dose will be adjusted as needed.

This, as far as I am aware, is a first as the ingestion of antidepressants by pregnant mothers has never been studied in a clinical trial before because, to date, it has always been deemed unethical. It throws up debate, much of it centered around antidepressants and the birth defect link, although this study's aim is not to prove whether or not antidepressant use in pregnancy can harm the fetus.

Very little has been mentioned in the press about this study save for a spattering here and there citing a study in mice whereby it was shown that mice with the extra copy of Down syndrome genes (like humans with DS), apparently improved the disturbed processes of brain development/function when treated with Prozac.

It's a tricky area as the target subject in this new study are both pregnant mothers and fetuses that have already been deemed to be carrying DS genes. Any help DS children can get in life should be applauded but is it right to put them at risk?

Half of the funds for the study have been raised by father, Paul Watson, who heard about the success of the studies in mice. Paul's son was born with Down syndrome.

Here's NBC reporting on the study... (If video does not load then it can be viewed here)




For years Prozac has been cited as one of the more safer SSRis on the market, in the UK, for example, it can still be prescribed to minors legally, the only SSRi that, apparently, does not show evidence of inducing suicidal thoughts in children and teenagers taking it. Surprisingly, the American drug regulator, the FDA, feel that Prozac should, just like the other SSRis on the market, carry a black box warning listing the dangers of its use in children and adolescents. As with all SSRis Prozac has never been deemed safe to give to pregnant mothers, that decision is left to both treating physician and the mother.

This study bothers me somewhat. Who has made this decision whereby it is now deemed ethical to study an antidepressant in a living fetus, end of the day a fetus with the down syndrome gene has just as much right to life as a "normal, healthy" human fetus.

Why has this study been given the green light, moreover, isn't this merely a guinea pig trial using a drug that can potentially cause more harm to the fetus on someone (the fetus) who has no say in the matter?

The study's lead author, Dr. Carol Tamminga, said, "the medical community has been giving Prozac to children with Down syndrome for years, but the effects of giving it to children in utero haven’t been tested." She added, "and this will really be the first controlled trial where we will get to test does this really work or not."

Tamminga's biography page shows that she has served as a Member and Chair of the Psychopharmacological Drugs Advisory Committee of the FDA. However, there is no mention of the payments made to her by Prozac manufacturers, Eli Lilly.

Jan. to Dec. 2011 - $1,574 for Business travel and other value.

Jan. to Dec. 2013 - $466 for Business travel and other value.

Jan. to Dec. 2013 - $267 for  Business Meals.

Tamminga has also received research support from Sunovion and travel funds from Autiphony Therapeutics and has served as a consultant for Astellas, Kaye Scholer LLC for Pfizer, and Lundbeck.

According to Drugwatch it is estimated that thousands of people have filed Prozac lawsuits citing a variety of adverse events including mental, emotional and physical suffering. Early cases have claimed that Prozac has caused an increased risk of suicidal thoughts and violent behaviour. Drugwatch also claims that by the year 2000 Prozac manufacturer, Eli Lilly had reportedly paid out more than $50 million to settle more than 30 Prozac lawsuits related to murders or suicides.

Drugwatch also claims that Prozac has been linked with birth defects, including anencephaly, a fatal defect in the neural tube. Newborns also can experience septal defects, damaged hearts or cleft lip or palate.

Yet here we are in 2016 putting this powerful SSRi into the bodies of pregnant mothers who are carrying a fetus with DS genes. Furthermore, here we are in 2016 giving a newborn baby from the age of 0-2 years the liquid formulation of Prozac.

Background of the study can be read here. Results are expected to be available within 12 to 18 months.

I do hope all the participants are given all the information about Prozac, including the information about the $50 million paid out in Prozac lawsuits related to murders or suicides and also Prozac's link to birth defects.

I honestly don't know what to say anymore.

Bob Fiddaman.


Related

Prozac Took My Child (Guest Post)

Open Verdict Returned in Prozac Related Death

The Mental Health "Stigma"

Two news items of interest were sent to me over the past few days, both, it would seem, are aligned with one another.

First off, let's take a look out the worn out phrase that lots of mental health specialists and even celebrities seem to trawl out every 5 minutes or so.

The mental health stigma

This from the Mental Health Commission in Australia, I plucked the first one that appeared in a Google search, all mental health foundations say pretty much the same.

Three out of four people with a mental illness report that they have experienced stigma. Stigma is a mark of disgrace that sets a person apart. When a person is labelled by their illness they are seen as part of a stereotyped group. Negative attitudes create prejudice which leads to negative actions and discrimination.

There's not a day goes by when we hear the calls of organizations or celebrities calling for an end to mental health stigma. Canadian writer and actress, Mary Walsh, is one such celebrity.

Walsh is a spokesperson for Bell Let's Talk, an organization that has, according to their website, "Committed over $100 million to support a wide range of mental health organizations, large and small, from coast to coast to coast."

Bell Media is Canada’s premier multimedia company with leading assets in television, radio, out-of-home advertising, and digital media. Bell Media owns 30 local television stations led by CTV, Canada’s number 1 television network.

Today, Today, Bell will donate 5¢ more to mental health initiatives for every:

• Text message sent
• Mobile & long distance call made
• Tweet using #BellLetsTalk
• Share of the Facebook image

That's a very generous offer given that the figure could run into the millions of dollars.

I'm in agreement with them to a certain extent. Yes, we should talk about mental health but the subject matter shouldn't be what more can they do to help depressed people, it should be what harm are they doing to depressed people.

BellLetsTalk, however, seem to back up their stigma claims with some "facts", of which there are many. Here's a few...

In Canada, only 1 out of 5 children who need mental health services receives them. - CMHA

Mood and anxiety disorders impact an estimated 22% of the Canadian population. - CMHA

Suicide accounts for 24% of all deaths among 15-24 year-olds and 16% among 25-44 year-olds. - CMHA

CMHA stands for the Canadian Mental Health Association, their homepage shows one of their principle sponsors to be Lundbeck, manufacturers and marketers of such drugs as Celexa (citalopram) and Lexapro (escitalopram) - which leads me nicely to the second news item that was sent to me this week.

Yesterday the New York Times (NYT) ran a feature regarding an apparent influential government-appointed health panel who have called for women be screened for depression during pregnancy and after giving birth.

Their claims, according to the NYT, "comes in the wake of new evidence that maternal mental illness is more common than previously thought; that many cases of what has been called postpartum depression actually start during pregnancy; and that left untreated, these mood disorders can be detrimental to the well-being of children."

The panel gave its recommendation, which was published in the journal JAMA, a “B” rating, which means depression screening must be covered under the Affordable Care Act.

In the NYT feature a woman/mother is quoted, seemingly to support the call for "maternal mental illness."

Melissa Mead, 30, of The Dalles, Ore, tells the NYT that shortly after her son Brady’s birth, she experienced postpartum depression, anxiety and O.C.D. In her own words she "cried continually, barely slept, rarely left home and was scared to death that my baby was going to suffocate."

Hello!

Isn't this a normal response to giving birth, isn't this just a motherly instinct?

The NYT goes on to say that...

After a year, she saw a psychiatrist for talk therapy. When her second son, Emmett, was born, and she had more symptoms, including fearing that she would stab herself with a kitchen knife, Ms. Mead tried several medications until one worked. She now volunteers for Postpartum Support International.

Several medications until one worked? Are we led to believe that some of them didn't work? Shock, horror, you mean some antidepressants don't work?

Mead is now a volunteer for Postpartum Support International (PSI), an organization whose purpose it is to increase awareness among public and professional communities about the emotional changes that women experience during pregnancy and postpartum.

In 2015 the PSI and Tree of Hope Foundation held their Annual Conference. The conference theme was "Planting seeds of hope: overcoming stigma, increasing options and embracing innovative treatments."

Ah, there's that word - "treatments."

Because the NYT featured a woman's story to support the calls for more screening for women with "maternal mental illness", I thought I'd throw in a story about the kind of treatments used to treat mothers during pregnancy.

Lundbeck's Celexa (citalopram) is one such treatment.

Back in 2013 Scottish mom, Cheryl Buchanan, wrote a guest post for this blog. It was with regard to the birth defects caused to her unborn child. Cheryl aborted her child at 23 weeks after being told that the fetus had severe abnormalities which meant she was incompatible with life.

Cheryl has been at loggerheads with Lundbeck regarding the death of her baby girl.

Scans had detected a series of anomalies in her unborn child, namely...

• Diaphragmatic hernia or eventration
• Long bone immobility
• Cystic hygroma 
• Unilateral cleft hand
• Microgynathia

Cheryl had been taking Lundbeck's citalopram prior and during her pregnancy.

Lundbeck carried out an assessment of Cheryl's claims and forwarded their findings to the MHRA.

Lundbeck, as far as I am aware, also use the World Health Organisation "causality categories".

Here's what they found.

• (Foetal death in utero) - drug related - possible
• (Pulmonary hypoplasia) - drug related - possible
• (Diaphragmatic hernia) - drug related - possible
• (Hand deformity) - drug related - possible
• (Skin laxity) - drug related - possible
• (Skin swelling) - drug related - possible
• (Drug exposure in utero) - drug related - possible

The actual documents can be viewed here.

Now, I'm sure many people get the cold shoulder treatment when diagnosed (labelled) with a mental illness - but is there really a stigma attached to it?

I'll go out on a limb here and suggest that there is more of a stigma attached to people like Cheryl Buchanan speaking out against the use of antidepressants during pregnancy - people like Cheryl are deemed irresponsible for taking the stance that she has - normally by healthcare professionals and those who wish to believe that antidepressants are safe during pregnancy.

You want facts?

During the citalopram animal reproduction studies it was shown that citalopram has been shown to have adverse effects on embryo/fetal and postnatal development, including teratogenic effects resulting in in decreased embryo/fetal growth and survival and an increased incidence of fetal abnormalities (including cardiovascular and skeletal defects) (Source FDA)

Meantime, more calls for screening women for mental health illnesses is being touted in the widely read New York Times. If you think the pharmaceutical companies, including Lundbeck, aren't behind this latest push then think again.

Both stories call for more help with the stigma associated with mental illness, of course they do - Big Pharma have something to sell and they want you in their corner helping them push their drugs on unsuspecting mothers.

Bob Fiddaman

Lundbeck: Contradiction in Terms

One of the more popular posts on this blog over the past couple of years has been a guest post by Scottish mom, Cheryl Buchanan. In short, Cheryl aborted her fetus at 23 weeks because she was told that its chances of survival were slim due to several defects.

A series of other posts by Cheryl and myself have appeared on this blog and now, it seems, the mainstream media in the UK have taken an interest. All good, I hear you cry - I guess so, it's good when stories like this are highlighted in the British press but, to be honest, journalism isn't what it used to be. In fact, the article, published on Jan 10 in The Express, leaves more questions than answers, questions that really should have been asked by the reporting journalist, Paula Murray.

Her article highlights Cheryl's plight and also tries to offer balance in the shape of a quote from Lundbeck's Medical Director, Dr. Andrew Jones.

Dr Andrew Jones, Medical Director with Lundbeck, said citalopram should not be prescribed during pregnancy unless "clearly necessary and only after careful consideration of risk/benefit".

However, he said there was "considerable evidence" to show that women who stop taking antidepressants during pregnancy are more likely to suffer a recurrence with "greater risks to the woman and her unborn child than the potential risks of exposure to the medication".

Dr Jones added: "We are familiar with Ms Buchanan and have supported her with the information she has requested. It is always a tragic situation when one loses a child. We will not comment on her personal case in public but the safety of Lundbeck’s antidepressants is supported with the large amount of data that has shown no evidence of an increased risk of birth defects associated with treating pregnant women with citalopram."

I left a comment on the Express article suggesting that Jones was having his cake and eating it, sadly, for some bizarre reason, that comment has been removed. Kind of weird given that the journalist in question was given the links to Cheryl's story that have appeared on my blog over the past couple of years.

Why didn't the journalist ask Dr. Jones for the  "considerable evidence" that shows that women who stop taking antidepressants during pregnancy are more likely to suffer a recurrence with greater risks to the woman and her unborn child than the potential risks of exposure to the medication?

Why didn't the journalist ask Dr Jones about the citalopram animal reproduction studies where it was shown that citalopram has been shown to have adverse effects on embryo/fetal and postnatal development, including teratogenic effects resulting in in decreased embryo/fetal growth and survival and an increased incidence of fetal abnormalities (including cardiovascular and skeletal defects) (Source FDA)

Furthermore, why wasn't Jones pushed for an answer in defining the terminology, Possibly, Probably or Certain? There's a whole new can of worms there for anyone seeking that Pulitzer.

Contrast the citalopram animal reproduction studies with the claim of Dr Jones that women who stop taking antidepressants during pregnancy are more likely to suffer a recurrence with "greater risks to the woman and her unborn child - it's a theory folks, one that has been blown out of the water many times by other academics. The citalopram animal reproduction studies is the actual science here and really should have been picked up by the reporting journalist.

Dr Jones is towing the company line, ie; he's keeping lawyers at bay and expectant mothers at risk - throwing in the line, "citalopram should not be prescribed during pregnancy unless clearly necessary and only after careful consideration of risk/benefit", is nothing more than a mandatory disclaimer used by pharmaceutical companies, they know their drugs are being used in pregnancy yet they just sit back and allow it to happen because they believe the prescribing physician is in a better position to judge whether or not the patient will benefit from the drug. Lines such as " women who stop taking antidepressants during pregnancy are more likely to suffer a recurrence with "greater risks to the woman and her unborn child", will always persuade prescribing physicians that antidepressant drugs are a must for depressed mothers - even though this statement is merely a theory.

Begs the question why Jones failed to mention the citalopram animal reproduction studies to the investigating journalist.

Meantime, Cheryl Buchanan remains in limbo and her child, through no fault of her own, remains dead.




Bob Fiddaman.

Back Stories

Citalopram Birth Defects (Guest Post)

Are Lundbeck Luring Pregnant Mothers With a Red Apple?

Lundbeck: Possibly, Probably or Certain about Celexa Birth Defects?

Two Facebook Statuses That Say It All

Seroxat (Paxil) withdrawal...

If you, like many thousands, find difficulty when trying to wean yourself off Seroxat (known as Paxil in the US and Aropax in Australia) then you'll know that there is no guidance.

The manufacturers, GlaxoSmithKline, refuse to help - Any correspondence sent to them during your horrific withdrawal will be met with the bog standard replies of "We are not allowed to discuss individual cases blah, blah..."

Your prescribing healthcare professional will, more than likely, refer to the product monograph which really tells them that there isn't a huge problem when patients taper from Seroxat - the product monograph, if you didn't know, is crafted by the drug company.

The medicines regulator, be they the British MHRA, the American FDA or the Australian TGA, will shrug their shoulders then scurry back to their various rat holes in the hope that you don't disturb them again.

Internet forums will offer various tidbits of information, you'll show your prescribing physician and he/she will probably tell you that these types of forums are run by conspiracy theorists.

~Bob Fiddaman


--

As I was getting nowhere debating back and forth with the MHRA and Pharmaceutical company Lundbeck I decided to write to the Minister for Public Health, Jeremy Hunt, about my daughters death which I believe was caused by the SSRI Citalopram. She was fatally malformed, incompatible with life. I had been given a "prescribed overdose" (according to lundbeck) by my GP unwittingly throughout the pregnancy and thoroughly reassured that it was not a teratogen. I was on a prescribed dose of 60mg, this dosage was the maximum back in 2004, but was lowered a few years ago to 40mg by the manufacturer and the MHRA as it was known to cause the heart condition "Long QT syndrome" and sudden death in adults. Today I was very surprised to have received a response -

Dear Miss Buchanan,

Thank you for your correspondence of 5 October to Jeremy Hunt about citalopram. I have been asked to reply.

I was very sorry to read about the death of your daughter and the circumstances surrounding her cremation.

However, the Department of Health is unable to comment on individual cases.

The Medicines and Healthcare products Regulatory Agency (MHRA) has provided the following information.

Citalopram is a member of the class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). SSRIs are used to treat depression in pregnant women in cases where there are no safer alternative effective treatments. The decision to prescribe SSRIs requires a careful evaluation of the need for treatment and any known risk of harm to the mother and/or foetus. Untreated depression during pregnancy is known to be harmful to the mother and foetus.

Some studies have suggested a small increased risk of birth defects with some SSRIs. Data has shown that paroxetine and fluoxetine are associated with an increase in risk of birth defects in the baby if the mother takes them in the first trimester. The background rate for birth defects is two to three per cent of all pregnancies. Current available data is insufficient to prove birth defects occur more commonly after taking citalopram than this background rate.

It is known that all the SSRIs can be associated with an increased risk of persistent pulmonary hypertension, a heart condition in the newborn, when taken later in pregnancy. Neonatal withdrawal and toxicity reactions have also been reported when SSRIs are taken in later pregnancy.

Several important changes to the citalopram prescribing information were introduced by the MHRA in 2011, including maximum dose restriction in adults after a detailed review of data showed citalopram was associated with a dose-dependent increased risk of abnormal heart rhythm.

The MHRA continues to monitor the safety of use of SSRIs in all patient populations very closely and all new data are rigorously assessed to evaluate the need for further regulatory action.

I am sorry I cannot be more helpful, but I hope this reply helps to clarify the situation.

Yours sincerely,

Malcolm Jones
Ministerial Correspondence and Public Enquiries
Department of Health

-------------------------------------------------------------------------------------------------------

I'm sorry to see that, once again, I have been given the usual spiel about the MHRA monitoring medications such as these, but what use is monitoring them if, when issues are flagged up, they chose to do absolutely nothing about it? I have never had once single invitation from the MHRA to converse with them or provide them with further information on my daughters death, this is despite me contacting them fairly regularly for over the past two years.

What else can I do? Is there anywhere else I can turn, anything I can try? I'm not giving up on this. I won't ever give up.


Cheryl Buchanan


--


Says it all really...



Bob Fiddaman

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