By Aaron Reiss
By Angelica Leicht
By Dianna Wray
By Aaron Reiss
By Camilo Smith
By Craig Malisow
By Jeff Balke
By Angelica Leicht
In the '60s the FDA won praise for rejecting approval of thalidomide, a sedative marketed to pregnant women that became infamous for producing birth defects such as flipperlike arms. But that was a different agency, he says, from the one that took 15 years to succumb to evidence of a suicide risk in SSRIs.
In fiscal year 2004 the FDA collected some $250 million from drug companies, nearly half its drug-review budget. At the federal level, congressional committees and the Government Accountability Office recently have criticized the agency for failing to scrutinize drug safety. This summer the FDA announced plans to write new guidelines specifying when scientists and doctors serving on advisory panels should be disqualified because of conflicts of interest.
Further complicating the issue are recent revelations that several doctors considered opinion leaders on the risks of antidepressants have financial ties to drug companies.
In July, The Wall Street Journalrevealed that a study published in the Journal of the American Medical Association, which warned that pregnant women who stop taking SSRIs are more likely to relapse into depression, was created by authors paid as consultants and lecturers by makers of antidepressants.
According to Breggin, it should come as no surprise that SSRIs are harmful to fetuses, since the drugs cross the placenta barrier and even enter the breast milk. Paxil, he says, is particularly toxic.
"The drug should not be given to pregnant women, period," Breggin says. "The fetus is bathed in Paxil. The developing brain and the developing lungs are growing in response to the drug, and that can't be good."
A faint, thin scar extends from the base of Chase's neck to his bellybutton, covering one quarter of his pale little body.
On January 27, 2006, three days after his nail beds turned blue, Chase underwent open-heart surgery at Texas Children's Hospital. The operation went as well as could be expected.
Two weeks later he unleashed a hair-raising scream from his crib unlike anything his mother had ever heard.
Chase had suffered three consecutive strokes due to a blood clot caused by the operation, a cardiologist later discovered.
Following the strokes, seizures gripped his body, causing his eyes to roll back and his head and limbs to fold forward and convulse. He has since experienced seizures on a near-daily basis.
The surgery saved his life. But it changed him.
Blame it on the stroke, the half-dozen medications he takes daily or a combination of the two, but Chase today often appears catatonic. His facial features drag; his motor skills are delayed, his breathing labored.
Doctors warn he will need repeated heart surgeries. He may one day require artificial replacement valves and a heart transplant.
He is examined monthly by a cardiologist, a hematologist and physical and occupational therapists. He has been rushed to the ER ten times in nine months.
Lisa Collins quit her job as an office manager to take care of Chase full-time. She and the child's father, 29-year-old Radford Steele, agree that stress over the baby dissolved their five-year relationship.
Last month Collins moved in with her grandparents across from Friendswood High School. A poster hangs in the kitchen, demonstrating how to perform CPR on an infant.
Collins has warned other pregnant women against using Paxil. Since she began publicizing her experiences, several Houston-area women have come out of the woodwork with similar stories and are now working to file their own suits against GlaxoSmithKline.
Cassandra Burdick, a 41-year-old Galveston resident and taxi driver, took Paxil during her first trimester to help level out her mood. Burdick's doctor assured there was no risk involved. Last June she delivered a boy with no pulmonary artery, among other deformities. Never allowed to leave the hospital, Nicholas died two months later.
"Tubes," she says. "That's all he knew his whole life was tubes."
Despite their better judgment, Collins, Burdick and others hold themselves responsible.
"My baby was cut from top to bottom," Collins says, "and I may have taken something that caused him to go through all of this."