The research team reported that 14 infants developed PPHN after being exposed to an SSRI after the 20th week of pregnancy, compared with only 6 infants in the control group. The researchers calculated an increased risk of 6-fold in infants exposed to SSRIs.
"The frequency of infant death up to the time of maternal interview was 3% in the persistent pulmonary hypertension group and 0% in the control group," the study noted.
In contrast, the authors said, the use of non-SSRI antidepressants at any time during pregnancy was not associated with an increased risk of PPHN.
Infants born with the disorder often require mechanical assistance to breathe and between 10 and 20% die soon after birth. Those infants who do survive often experience developmental delays, hearing loss and brain abnormalities.
In July 2006, late on the draw as usual, the FDA finally got around to adding the warning about PPHN to the Paxil information sheet to state:
"The results of a study that looked at the use of antidepressant medicines during pregnancy in mothers of babies born with a serious condition called persistent pulmonary hypertension of the newborn (PPHN) were recently published in a medical journal."
"Babies born with PPHN," the FDA wrote, "have abnormal blood flow through the heart and lungs and do not get enough oxygen to their bodies. Babies with PPHN can be very sick and may die."
Critics say, Dr. Cohen's study was clearly published in JAMA to overshadow the bad publicity that was sure to follow the news about the lung disorder. However, according to Dr. Baughman, a fact not mentioned in the study, is that Dr. Cohen is on the paid speakers bureau for numerous drug companies.
In fact, as it turns out, Dr. Cohen has conflicts of interest stemming from all directions. According to the July 11, 2006, Wall Street Journal, he "is a longtime consultant to three antidepressant makers, a paid speaker for seven of them and has his research work funded by four drug makers."
The study also failed to mention that most of the other 13 authors were paid as consultants or lecturers. "In total," the WSJ reports, "the authors failed to disclose more than 60 different financial relationships with drug companies."
And come to find out, besides publishing the study, Dr. Cohen and some of the other authors hit the lecture circuit, traveling around the country telling doctors about their findings while pointing out flaws in studies that found increased risks of health problems with infants associated with mothers who used SSRIs during pregnancy.
When contacted by the WSJ, the editor-in-chief of JAMA, Catherine DeAngelis, said the journal was not aware at the time the study was published of the relationships Dr. Cohen and some of the co-authors had with drug companies.
"As soon as JAMA found out that they didn't disclose," she said, "we contacted the corresponding author, Dr. Cohen, and asked for his explanation."
"We have one and it will be published very soon in an upcoming issue of JAMA," she added.
Dr. Cohen's response in JAMA was to say the study did not address the question of whether "antidepressants as a whole or a particular antidepressant" should be prescribed and so he and his colleagues saw no potential conflict of interest.
According to Dr. Baughman, "JAMA, and all journals, should be made to publish clear, detailed statements regarding all of their financial ties."
"The frequency of infant death up to the time of maternal interview was 3% in the persistent pulmonary hypertension group and 0% in the control group," the study noted.
In contrast, the authors said, the use of non-SSRI antidepressants at any time during pregnancy was not associated with an increased risk of PPHN.
Infants born with the disorder often require mechanical assistance to breathe and between 10 and 20% die soon after birth. Those infants who do survive often experience developmental delays, hearing loss and brain abnormalities.
"The results of a study that looked at the use of antidepressant medicines during pregnancy in mothers of babies born with a serious condition called persistent pulmonary hypertension of the newborn (PPHN) were recently published in a medical journal."
"Babies born with PPHN," the FDA wrote, "have abnormal blood flow through the heart and lungs and do not get enough oxygen to their bodies. Babies with PPHN can be very sick and may die."
Critics say, Dr. Cohen's study was clearly published in JAMA to overshadow the bad publicity that was sure to follow the news about the lung disorder. However, according to Dr. Baughman, a fact not mentioned in the study, is that Dr. Cohen is on the paid speakers bureau for numerous drug companies.
In fact, as it turns out, Dr. Cohen has conflicts of interest stemming from all directions. According to the July 11, 2006, Wall Street Journal, he "is a longtime consultant to three antidepressant makers, a paid speaker for seven of them and has his research work funded by four drug makers."
The study also failed to mention that most of the other 13 authors were paid as consultants or lecturers. "In total," the WSJ reports, "the authors failed to disclose more than 60 different financial relationships with drug companies."
And come to find out, besides publishing the study, Dr. Cohen and some of the other authors hit the lecture circuit, traveling around the country telling doctors about their findings while pointing out flaws in studies that found increased risks of health problems with infants associated with mothers who used SSRIs during pregnancy.
When contacted by the WSJ, the editor-in-chief of JAMA, Catherine DeAngelis, said the journal was not aware at the time the study was published of the relationships Dr. Cohen and some of the co-authors had with drug companies.
"As soon as JAMA found out that they didn't disclose," she said, "we contacted the corresponding author, Dr. Cohen, and asked for his explanation."
"We have one and it will be published very soon in an upcoming issue of JAMA," she added.
Dr. Cohen's response in JAMA was to say the study did not address the question of whether "antidepressants as a whole or a particular antidepressant" should be prescribed and so he and his colleagues saw no potential conflict of interest.
According to Dr. Baughman, "JAMA, and all journals, should be made to publish clear, detailed statements regarding all of their financial ties."
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