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Medical miracle turns nightmare - Wonder drug for men alleged to cause harm in women

by Kay LazarBoston Herald
August 22nd, 1999

First in a two part series

Something strange happened to Susan Hayward while taking a drug called Lupron for a gynecological problem. She started losing her memory.

That was in 1992, when Hayward was 36.

Over the next five years, Hayward, a healthy, active postal worker, was given 18 more injections of the drug. Other curious health problems followed. She developed herniated discs, her body ached all over, and her memory worsened.

Two years after she stopped taking the drug, Hayward, now 43 and living in Carver, is on disability and has trouble remembering basic things, like conversations she had earlier in the day. She suspects Lupron triggered irreversible changes in her brain.

"I went to college and I feel like I am an idiot now, because I can't remember anything," Hayward said. "There has to be some connection."

Hayward is hardly alone.

Scores of women nationwide have reported to federal health officials serious side effects from Lupron, a drug originally developed to treat men with advanced prostate cancer but now widely used to treat women for a variety of routine gynecological problems.

The serious side effects reported by women include tremors, seizures, memory loss and joint pain. The problem is, some women say these side effects are not going away - even after they stop taking the drug.

Lupron's manufacturer insists its product is safe. The Food and Drug Administration, the federal agency that approves drugs for public use, says the benefits from Lupron outweigh the risks.

But a growing number of women, women's health advocates and medical ethicists question that, saying the potent drug designed for men who have few other treatment options for advanced prostate cancer is being widely used on young, healthy women - without enough studies to show whether it causes long-term, and possibly irreversible, side effects.

"Lupron is something that sends a substantial number of women into a tailspin," said Judy Norsigian, program director for the Boston Women's Health Book Collective, a co-author of "Our Bodies, Ourselves." "It's one of the drugs that we feel has not been adequately assessed."

Despite this worry, dozens of interviews of women and medical experts by the Sunday Herald indicate Lupron is commonly used by doctors, including specialists who prescribe it for treatment of infertility in women.

The FDA has never OK'd Lupron for infertility treatments. And medical experts and women's advocates say not enough studies have been done to show whether Lupron is safe or effective for that use.

Yet the FDA allows Lupron to be used for infertility treatments because under federal law, once a drug is approved for one use, doctors can prescribe it for any use.

"I have used Lupron (on infertility patients) for as long as it's been available," said Dr. Richard Reindollar, director of the division of Reproductive Endocrinology at Beth Israel Deaconess Medical Center. Reindollar also holds a similar position at Boston IVF, one of the region's highest-volume infertility clinics.

"While many patients do not like the side effects of Lupron, I do not remember one patient with such an extreme reaction requiring her to stop the medication," Reindollar said.

Lupron, which is given by injection, was first approved by the FDA in 1985 solely for treatment of men with advanced prostate cancer. The drug is made by Deerfield, Ill.-based TAP Pharmaceuticals Inc., which is a joint venture of Abbott Laboratories and Takeda Chemical Industries, Japan's largest drug company.

By 1989, a year before the FDA granted TAP permission to market the drug for limited use in women, TAP was aggressively promoting Lupron to obstetricians and gynecologists, FDA records show.

The FDA warned TAP in a March 1990 letter that, "Your firm has undertaken a deliberate campaign to promote this product for a wide range of unapproved uses." The letter warned the company to stop such promotions, especially the distribution of brochures targeted at consumers.

"They claim that Lupron is safe and effective, and actively promote its administration in a range of indications for which Lupron is not approved and apparently has not been adequately demonstrated to be safe and effective," the letter noted.

After finishing its review of the drug, the FDA approved Lupron in October 1990 for limited use in women, for the treatment of endometriosis. In 1995, the FDA OK'd the drug for treatment of uterine fibroids.

To date, the FDA reports 6,272 complaints filed for adverse side-effects from Lupron - 553 have come within the past 20 months.

During the past two years roughly 2 million prescriptions were written for Lupron in the United States, according to IMS Health, a Pennsylvania company that tracks prescription drugs.

The FDA's records also include 25 women's deaths where Lupron was listed among the suspected, but not proven, causes.

The number of suspected problems could be even larger, because the FDA itself says such "adverse events" are generally underreported. The agency notes that 90 percent of adverse reports come from drug manufacturers, who are required by law to report adverse effects. Doctors are not required to report bad side effects to the FDA, but may report them on a voluntary basis, to the FDA or the drug manufacturer.

The FDA also says that it has not "scientifically or otherwise verified" any link between Lupron and the reported adverse effects.

However, at least one document indicates there is concern within the FDA about the growing reports of adverse effects from Lupron. In a March 24, 1999 memo, obtained by the Sunday Herald under the Freedom of Information Act, an FDA epidemiologist who reviewed Lupron reports concluded there were "high prevalence rates" for serious side effects. She suggested her agency consider a "re-examination of the product label to ensure that these events are adequately addressed."

In an interview, Dr. Marianne Mann, the FDA's deputy director for the Division of Reproductive and Urologic Drug Products, said her department did review its data after that report and decided no additional action was needed.

"Our clinicians reviewed this data and reviewed the Lupron (package warnings) and we feel the current Lupron (warnings) adequately reflects these concerns," Mann said.

Like many drugs, Lupron comes with inserts warning of a number of potentially serious side effects, including: depression, joint disorders plus loss of bone density, or osteoporosis.

Yet none of the warnings - except for bone loss - state the side effects might continue long after stopping use of the drug.

However, seven of the women interviewed for this story say they suffered memory loss and bone aches while on Lupron, and that the problems continue years after stopping the drug. Some say seizures and serious vision problems that started while on Lupron also haven't gone away.

One woman, Linda Abend in southern New Jersey, started a National Lupron Victims Network after her 34-year-old sister was hospitalized with seizures while taking Lupron in 1991 for a benign fibroid. Abend says her sister continues to suffer daily seizures, plus debilitating bone and muscle pain eight years later. And Abend said she has heard from more than 1,000 people nationwide - mostly women - who also report serious side effects that continue after stopping Lupron.

The FDA says it has not tracked claims of such long-term effects.

"Our post-marketing system works on getting information from these adverse events," Mann said. "We accumulate data over time, and it takes a while to get this data. At present we feel the label adequately addresses these issues."

But University of Pennsylvania bioethicist Glenn McGee, who specializes in reproductive issues, says the FDA is making a mistake.

"We just don't know yet what Lupron causes," McGee said, "but there is enough evidence that something is wrong and that the FDA should initiate studies."

Despite the mysterious health problems some link to Lupron, others swear by the drug.

Manny Hamelburg, of Braintree, says Lupron saved his life. Hamelburg, 59, started taking Lupron in 1992, when he was diagnosed with advanced prostate cancer and given a bleak prognosis.

Hamelburg said he believes his cancer is in remission because of Lupron. But, he said, he stopped taking Lupron this May because he was diagnosed with osteoporosis, which he believes was caused by Lupron.

"Lupron was a wonder drug, but it was costly," Hamelburg said. "I have hot flashes, loss of libido, I've gained weight, I'm over 300 pounds, my breasts are enlarged. I can live with these. They are a pain in the neck, but they are livable."

In a statement, TAP Pharmaceuticals said it has "compassion" for the long-term side effects a growing number of women have complained about. The company also said its product is safe and has helped many patients.

"Since Lupron's approval, which was nearly 10 years ago, hundreds of thousands of endometriosis and uterine fibroid sufferers have used Lupron safely, and Lupron has not been found to have any irreversible or lasting side effects," said TAP's Kim Modory.

Yet the case of Victoria Lee Burns in Maryland raises questions about that claim.

In 1991, Burns, who was in her 20s and working in a bank, took five monthly injections of Lupron for endometriosis and ended up hospitalized for severe arthritis-like symptoms, according to her lawyer, Nicole Schultheis.

"Contrary to what was stated in the literature, her symptoms were not reversible upon cessation of therapy," Schultheis said, adding that her client remains permanently disabled from Lupron, and struggles daily with walking, driving and standing.

Burns sued TAP Pharmaceuticals in 1994.

"They refused to produce documents until I agreed I would keep them secret and I refused to do that," Schultheis said.

In January 1997, TAP settled the case. The terms of the settlement are secret.

TOMORROW: Women who have taken Lupron, and their campaign to get an investigation of the drug.



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