By Nicholas Regush Redflagsweekly.com

It's a disgrace. A drug named Lupron that is unapproved by the Food and Drug Administration for treatment of infertility is being used widely at infertility clinics.

There is no surveillance to speak of, no adequate research being done, and little or no informed consent. It's become a free-for-all and a glaring example of why modern medicine, drug companies and the FDA cannot be easily trusted.

Lupron, manufactured by Tap Pharmaceuticals Inc., is approved for treatment of men with advanced prostate cancer and for treatment of endometriosis and uterine fibroids.

That's it. Nothing more.

There is, however, a legal loophole, and one widened considerably by tradition. Once the FDA approves a drug for a specific indication, doctors can use it for any purpose. That's right, any purpose, and the more doctors that use it for an unapproved purpose, the more it becomes part of standard medical practice. It's assumed that along the way some real evidence, beyond whispers in hallways of hospitals or anecdotes spun at medical symposia (financed by drug companies), has actually been gathered, and maybe even published.

That may be the case with some drugs being used for unapproved indications, but I'd like to issue a challenge to Tap Pharmaceuticals and any medical body or doctor to pony up the "real" science that has been done to support the contention that the use of Lupron for treatment of infertility is safe and effective, over both the short-term and long-term.

Any public revelations that solid safety and efficacy data exist to support the use of Lupron in the treatment of infertility could be viewed as reassurance to women that they are not guinea pigs in some giant medical experiment - which I believe they are.

As things stand, for example, there are already many serious questions about the use of Lupron in the treatment of endometriosis, an approved indication. The studies supporting the approval were amazingly scant, and long-term research has seriously gone missing.

Endometriosis is a condition in which pieces of the lining of the uterus are found in other parts of the body, especially in the pelvic cavity. These pieces of endometrium respond to the menstrual cycle and bleed. Because the blood cannot escape, it builds up and causes the development of small or large painful cysts.

Lupron is a synthetic-like hormone that is said to act on this process by suppressing the ovaries and is supposed to temporarily interrupt estrogen output. This creates a drug-induced menopause. The goal of treatment is to shrink any lesions produced via endometriosis.

Many women with endometriosis who are given Lupron injections have horrendous side-effects, including cardiac arrythmias, dizziness, swelling, chest pain, depression and confusion, bone pain, extreme fatigue, vision loss, high blood pressure, and nausea. Some of the women claim their side-effects last long after treatment is completed.

TAP says its product is safe and that the normal function of the pituitary-gonadal system is usually restored within three months after Lupron injections are discontinued. The FDA agrees with the company.

It's fine for TAP to say their product is safe, but quite another to produce evidence on the basis of well-controlled long-term research that the pituitary-gonadal system is not altered in any way by Lupron.

Meanwhile, IVF doctors often use the very same drug - Lupron -for the treatment of infertility, an unapproved indication.

Usually Lupron injections are begun approximately one week after ovulation. The idea is to suppress female hormones that normally can produce one mature egg. Shutting off the body's production of hormones enables the IVF doctors to use hormonal preparations that can lead to multiple egg development.

Fine, but where's the solid science on safety and efficacy?

Red Flags Weekly March 11, 2002