in the form of glucose. Insulin becomes less effective in metabolizing glucose during pregnancy, which can cause some pregnant women to become diabetic. Insulin resistance during pregnancy must be treated because high sugar levels are toxic to a fetus and can cause birth defects. Geller Pharmaceuticals addressed the problem of insulin resistance during pregnancy by developing thalglitazone, which has the trade name Insufort. Insufort reverses the body’s insulin resistance and prevents diabetes and its complications.”
“But there are problems, right? Birth defects?” Kate said. “And isn’t there a connection between Insufort and the Thalidomide scare from the late 1950s?”
“Yes and no. One tabloid called Insufort the ‘Son of Thalidomide,’ and there is a connection. A drug called troglitazone helped pregnant women solve the insulin resistance problem, but it also may have caused liver failure. Geller’s scientists combined a glitazone with the thalido ring from Thalidomide and created a harmless product that helps pregnant women overcome diabetes during pregnancy.”
“So why are women who take the pill giving birth to deformed babies?”
“It’s either a compliance problem or coincidence.”
Kate looked at him with disgust.
“No, it’s true,” Daniel insisted. “Many of the women who claim that Insufort caused their child’s birth defect probably didn’t take the pill as prescribed. Maybe they took it occasionally or irregularly or only a few times and their glucose rose to dangerous levels.”
“So we’re blaming the victim.”
“Look, Kate, most women give birth to healthy babies, but some women give birth to babies who have problems. Sometimes we know why. Some anticonvulsant drugs cause cleft palate. Babies of older mothers are more prone to have birth defects. Maternal infections can also cause them. Then there’s alcohol, tobacco, and drugs. But the causes of most birth defects are medical mysteries. The difficulty is that Americans have been taught that there is an answer to every problem.” Daniel leaned forward and looked at Kate. “Americans can’t accept the fact that shit happens. You get cancer, so you blame overhead power lines; you run someone over, so you blame your car. Are you familiar with the Bendictin cases?”
Kate shook her head.
“ ‘Morning sickness’ is a problem for many pregnant women. For most it’s unpleasant, but it can be deadly. You’ve heard of Charlotte Brontë?”
“The author of
Jane Eyre
.”
Daniel nodded. “Hyperemesis gravida—‘morning sickness’—killed her. In 1956, the FDA approved Bendictin, which was developed by Merrill Pharmaceuticals as a therapy for women with severe morning sickness. In 1979, the
National Enquirer
announced that Bendictin was the cause of thousands of defects in infants.
“The best way to determine if there is a cause-and-effect relationship between a drug and a problem is to conduct an epidemiological study. If a control group that hasn’t taken the product has as many, or more, problems as the group that’s taken the drug, you can conclude that there’s probably not a casual connection between the drug and the problem. All of the epidemiological studies of Bendictin concluded that there was no statistical difference in the incidence of births of babies with defects in the two groups. That didn’t stop lawyers from convincing women to sue.”
“The plaintiffs’ attorneys must have had some evidence of a causal connection between the drug and the defects.”
“They used experts who altered the results of studies or conducted studies without proper controls or inaccurately reported doses. The plaintiffs lost almost every case because they couldn’t show that Bendictin was to blame for any defects, but it cost Merrill Pharmaceuticals a hundred million dollars to defend all of the cases. In the end, a perfectly safe product was taken off the market because of all the bad publicity and other drug
“But there are problems, right? Birth defects?” Kate said. “And isn’t there a connection between Insufort and the Thalidomide scare from the late 1950s?”
“Yes and no. One tabloid called Insufort the ‘Son of Thalidomide,’ and there is a connection. A drug called troglitazone helped pregnant women solve the insulin resistance problem, but it also may have caused liver failure. Geller’s scientists combined a glitazone with the thalido ring from Thalidomide and created a harmless product that helps pregnant women overcome diabetes during pregnancy.”
“So why are women who take the pill giving birth to deformed babies?”
“It’s either a compliance problem or coincidence.”
Kate looked at him with disgust.
“No, it’s true,” Daniel insisted. “Many of the women who claim that Insufort caused their child’s birth defect probably didn’t take the pill as prescribed. Maybe they took it occasionally or irregularly or only a few times and their glucose rose to dangerous levels.”
“So we’re blaming the victim.”
“Look, Kate, most women give birth to healthy babies, but some women give birth to babies who have problems. Sometimes we know why. Some anticonvulsant drugs cause cleft palate. Babies of older mothers are more prone to have birth defects. Maternal infections can also cause them. Then there’s alcohol, tobacco, and drugs. But the causes of most birth defects are medical mysteries. The difficulty is that Americans have been taught that there is an answer to every problem.” Daniel leaned forward and looked at Kate. “Americans can’t accept the fact that shit happens. You get cancer, so you blame overhead power lines; you run someone over, so you blame your car. Are you familiar with the Bendictin cases?”
Kate shook her head.
“ ‘Morning sickness’ is a problem for many pregnant women. For most it’s unpleasant, but it can be deadly. You’ve heard of Charlotte Brontë?”
“The author of
Jane Eyre
.”
Daniel nodded. “Hyperemesis gravida—‘morning sickness’—killed her. In 1956, the FDA approved Bendictin, which was developed by Merrill Pharmaceuticals as a therapy for women with severe morning sickness. In 1979, the
National Enquirer
announced that Bendictin was the cause of thousands of defects in infants.
“The best way to determine if there is a cause-and-effect relationship between a drug and a problem is to conduct an epidemiological study. If a control group that hasn’t taken the product has as many, or more, problems as the group that’s taken the drug, you can conclude that there’s probably not a casual connection between the drug and the problem. All of the epidemiological studies of Bendictin concluded that there was no statistical difference in the incidence of births of babies with defects in the two groups. That didn’t stop lawyers from convincing women to sue.”
“The plaintiffs’ attorneys must have had some evidence of a causal connection between the drug and the defects.”
“They used experts who altered the results of studies or conducted studies without proper controls or inaccurately reported doses. The plaintiffs lost almost every case because they couldn’t show that Bendictin was to blame for any defects, but it cost Merrill Pharmaceuticals a hundred million dollars to defend all of the cases. In the end, a perfectly safe product was taken off the market because of all the bad publicity and other drug
Similar Books
