By Nicholas Regush
This particular saga began a decade ago with an injection of a powerful prescription drug called Lupron. Lynne Millican took the shot for endometriosis, a condition in which pieces of the lining of the uterus are found in other parts of the body, especially in the pelvic cavity.
Ten years later, Millican believes she is still suffering from the effects of that injection. Her many symptoms have included the development of a noncancerous tumor, breast cysts, cardiac arrythmias, dizziness, swelling and fatigue.
Millican is a registered nurse (and paralegal) living in the Boston area who has become deeply involved in a grass-roots movement to force the U.S. Food and Drug Administration (FDA), and Members of Congress to take a close look at Lupron.
The FDA first approved Lupron in 1985 for treatment of men with advanced prostate cancer, and then approved it for treatment of endometriosis in 1990 and uterine fibroids in 1995.
"There are thousands in the United States who say they have been victimized by this drug," Millican said, emphasizing that symptoms can be severe, such as tremors, seizures and memory loss.
"Many women I know say their symptoms didn't stop when they stopped taking the drug."
The FDA has received a wide range of reports of serious side-effects, including death, suspected to be associated with the use of Lupron, but the agency, which holds that the drug's benefits outweigh the risks, does not believe there is sufficient proof to blame Lupron.
TAP Pharmaceuticals Inc., jointly owned by Abbott Laboratories and Takeda Chemical Industries of Japan, has steadfastly maintained that Lupron is safe.
Millican, who feels that the FDA has been very slow on the draw with Lupron, is also frustrated by the lack of response from almost all of the many senators and representatives in Congress to whom she has written. She has even submitted written testimony to various committee hearings - but to no avail.
"It seems that no one but the people who suffer from Lupron are interested in looking into this drug," she said.
Millican cannot even recall anyone with an MD degree who has voiced strong concern about Lupron.
At the very least, she feels Lupron's safety should be an issue because doctors use it for purposes that were never approved by the FDA. While legal under federal law - once approved for an indication, a drug can be used for other purposes - unapproved use often occurs without the benefit of appropriate safety and efficacy studies.
One of Millican's main concerns is Lupron's unapproved use in fertility clinics. The drug is essentially used to suppress female hormones which produce a mature egg. This allows fertility doctors to then induce "controlled" stimulation of multiple eggs.
"I am concerned that women who undergo these procedures are not being sufficiently informed about Lupron's side-effects," Millican said.
There is even much more at stake, according to Millican. On September 5, she provided testimony to congressional committee hearings on stem cell research, pointing out that the use of Lupron in the process of creating embryos may cause "the very diseases that are being claimed as those diseases necessitating embryonic stem cell research for a cure."
Millican finds it hard to swallow that the debate over stem cell research has totally ignored Lupron.
Redflagsweekly January 25, 2002