Part III: “Please don’t forget about me“: Antidepressants and birth defects

Lyam David-Kilker was born on 24 October 2005, the second son of Michelle David and Miles Kilker of Bensalem, Pennsylvania. At birth he seemed like a normal, happy, healthy infant, but all that soon changed. His breathing was labored, and he became lethargic and lost his appetite. His parents took him to the doctors, who delivered devastating news. Lyam was born with multiple cardiac defects: a hole in his atrial septum, a hole in his ventricular septum, along with transposition of the great arteries—the same condition which afflicted Christiane and Amery’s son Daniel. Lyam required two open-heart surgeries and spent the first six months of his life in the hospital.

Shortly before conceiving, Michelle David had been prescribed Paxil for mild anxiety and occasional panic attacks, and she continued to take the drug throughout her pregnancy. After Miles Kilker heard a commercial message on television for the law firm linking Paxil to congenital heart defects, Michelle called the number and was referred to Sean Tracey, a personal injury lawyer from Houston.

Part I: “Please don’t forget about me”: Antidepressants and birth defects

Part II: A gigantic uncontrolled experiment

During the trial, the plaintiff’s lawyers cited a couple of 2001 emails to GlaxoSmithKline from a woman (not Michelle David) who had taken Paxil while pregnant. The woman’s name was redacted from all court documents. The first email from her, dated 31 May, read:

“My name is [redacted]. I was diagnosed with panic disorder about four-and-a-half years ago. Since that time I’ve been taking Paxil, which is truly a miracle drug. I’ve been panic-free with this drug and have been able to go on with a normal life.

“I was married in October of 2000.My husband and I found out we were pregnant at Christmas time. I was so excited. I love children. The only problem is that I carried the baby to six months gestation and then had to have a termination.

“The doctors diagnosed my son with Truncus arteriosis. They said he would not lead a normal childhood and would most likely not make it through the open heart surgery that he would need as soon as he was delivered (if he was able to make it to that time). To say the least, I was absolutely distraught with this news.I thought this was something that I did, was because I stayed on the Paxil for selfish reasons.

“I wanted to know if you could direct me to any information you might have of any woman that has taken Paxil and still had healthy babies. My husband and I are ready to try again to get pregnant in the next month or two. I am so nervous. I don’t want to stop taking my miracle pill. But, then again, if there is a chance that this might hurt or affect the baby I want to know upfront. And I will somehow stop taking it for the time being.

“Please contact me as soon as possible. I love everything this drug has done for me. I am so thankful that your company had this available for me.I just want to continue to have a normal life and have the child that I always wanted. Please contact me as soon as possible.

“Please don’t forget about me,Thank you.”

GSK responded:

“Thank you for your inquiry. We are attaching a copy of our current product information for Paxil. Please review the section on use during pregnancy. Further questions about your treatment should be directed to the physician, pharmacist or healthcare provider who has the most complete information about your medical condition. Because patient care is individualized, we encourage patients to direct questions about their medical condition and treatment to their physician. We believe that because your physician knows your medical history, he or she is best suited to answer your questions.

“Our drug information department is available to answer any questions your physician or pharmacist may have about our products. Your healthcare professional can call our drug information department at 1-888…”.

Congenital malformations associated with this drug
At that time, the prescribing information for Paxil made no mention of the number of reports of congenital malformations associated with this drug, and it was company policy not to tell doctors, patients, or pharmacists, either.

On 1 June, the mystery woman wrote again:

“This response is in regards to an e-mail that I had sent you previously. I was asking to see if you have any or are in the process of any clinical trials for women who are currently on Paxil and pregnant. I wanted to find out information to see how many women were on Paxil during pregnancy and if they were able to successfully have healthy babies.

“I am in no way insinuating your product did this to my child. I love the product, and I don’t think I could have gotten through my panic attacks without the wonderful help of this miracle drug. I just want to start to try and get pregnant again soon. I do not want to put my unborn child through anything that would hurt him/her.

“Please, if you do not have this information, where is this information held? Does anyone do studies like this? Please, any information you may give me would be great.Thanks again for your help.”

GSK responded to the mystery woman’s query by certified mail, asking her to sign a form authorizing the release of her medical records to GSK. The letter never reached her—it was returned as “undeliverable” by the US Postal Service. GSK apparently made no further efforts to communicate with her, although they did send a Medwatch report to the FDA, stating that “mother’s concurrent medications and medical conditions were not specified.” An internal GSK document, dated 13 June 2001, stated the link between Paxil and the cardiac defects suffered by the mystery woman’s unborn fetus was “almost certain.”

Lawyers for GSK argued that somebody must have checked the “almost certain” box by mistake. The jury didn’t buy it, and on 29 October 2009 awarded $2.5 million to Lyam Kilker.

Lyam survived, but hardly unscathed. For the rest of his life he will suffer from high blood pressure and diminished energy, and he will need repeat surgeries to replace the grafts covering the holes in his heart.

On 2 July 2012, the United States Department of Justice announced that GlaxoSmithKline had agreed to pay $3 billion to settle claims of illegal marketing of its products, including Paxil—the largest such payout in history. The same day the settlement was announced, the value of GSK shares rose 1.3%.

David Healy is a Professor of Psychiatry at Bangor University and the author of Pharmageddon, and he also testified as an exert witness at the Kilker trial. In a telephone interview he blasted SmithKline Beecham for not following up on early indications that paroxetine could cause birth defects. “They didn’t do what they ought to have done, do the kind of studies that they ought to have done.” He likened their attitude to that of tobacco company executives confronted with evidence of the harm their product could cause: “Let’s not look too closely at this.”

The mystery woman was later identified as Joanne Thomas, and she subsequently filed a wrongful death suit against GSK. On 27 November 2013, the Common Pleas Court of Philadelphia ruled against her on the grounds that the developing fetus (whom she called Ryan) had not reached the age of viability when the pregnancy was terminated. The certificate of fetal death listed Ryan’s gestational age as 21 ¬Ω weeks, whereas 3 days before the pregnancy was terminated, a cardiologist estimated Ryan’s age at 22 weeks. According to Pennsylvania law, a fetus is not considered “viable” until the age of 23 weeks.

Next: Part 4: “Patient safety is our highest concern”

Written by Patrick D. Hahn for Canada Free Press ~ June 7, 2017.

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