Rose Mary and Joseph Schiesl were newly married and expecting their second child in 1962, a time when mothers abroad still took thalidomide during pregnancy to combat insomnia and morning sickness.
The Schiesls, of Fairfax, remember the deformed babies on the nightly news. They remember how lucky they felt to be protected by an American drug regulatory system that saved them, and their son, from a similar fate.
Now, 37 years later, Rose Mary Schiesl is one of 8,000 patients who are ingesting thalidomide. Each time she or her husband reaches for the unusual prescription packet of the drug, called Thalomid, they see the same deformed babies that made them say their prayers decades ago.
Under an unprecedented agreement worked out by the Food and Drug Administration and Thalomid's maker, Celgene Corp., no patient can receive a prescription for Thalomid without first signing a consent form and filling out a confidential questionnaire about frequency of sexual intercourse and use of birth control. The pills come in a package that contains further warnings and a photograph of a deformed "thalidomide baby."
"We understand why the company is doing this," said Schiesl, who is now a 59-year-old grandmother with two pregnant daughters-in-law. "The picture is to remind people that this should never happen again."
For Schiesl, who was diagnosed in November with myelodysplasia, a rare blood disorder, thalidomide is her only treatment option. Because she also has a kidney disorder that requires her to undergo dialysis, she is not eligible for other cancer treatments. It's too early to tell whether thalidomide will work for her.
The photograph that came with the prescription was startling, and she discussed it with her oncologist, Arthur Kales, who has treated six patients with thalidomide.
"Prescribing thalidomide is like prescribing no other drug," the oncologist said, referring to the unusually strict guidelines on the drug's availability.
"I guess it must be done so that this medicine doesn't fall into the wrong hands," Kales said. "Pills are out there. I don't blame the company. I think they are doing the right thing."
Rose Mary Schiesl agrees. Although she felt the questionnaire was far too personal and unnecessarily detailed for someone beyond childbearing years, her attitude was: If that's what it takes to prolong her life, so be it.
CAPTION: This photo of a thalidomide victim is included with new prescriptions to serve as a reminder of its potential for harm.