Lupron #1

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WHERE'S THE SCIENCE?

LUPRON, INFERTILITY, AND WOMEN AS GUINEA PIGS

 

By Nicholas Regush

 

March 11, 2002 - 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 for the pre-operative treatment of anemia resulting

from heavy bleeding associated with 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 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?

 

Other Unapproved Uses Of Lupron