Monday, August 22, 2005

iPLEDGE: an agenda?

Today, the Food and Drug Administration launched the website to accompany their iPLEDGE program for reducing the instance of pregnancy in women taking the acne medication isotretinoin (by its generic name, more commonly known as Accutane). The reason for this is the high risk of birth defects in children who are conceived during the use of this drug.

The important thing to note about the iPLEDGE program is that it is not optional. It is obligatory, government funded and government mandated. In fact, this program is run much like the coercive techniques of China's one-child policy. Except with iPLEDGE, it is not abortion that is mandatory, it is contraception. In order to be prescribed the medication, the woman must test twice within 19 days with a negative pregnancy test, "pledge" to take use at least two different contraceptive medications or devices in order to prevent pregnancy, and take a monthly pregnancy test with doctor supervision. Every girl, teen age female and woman is required to participate in the program, except those who have had a complete hysterectomy or bilateral oophorectomy (removal of both ovaries), or are doctor certified as post-menopausal.

Isotretinoin is the only drug that has been developed to treat the severe form of acne known as "nodular acne." These are deep, painful red sours that are the size of an eraser or larger. Side effects are serious for this drug, and include depression, psychosis, suicide, birth defects, serious brain problems (bad headache, blurred vision, dizziness, nausea and vomiting, seizures and stroke), stomach area problems (severe stomach, chest and bowel pain; trouble swallowing or painful swallowing; new or worsening heartburn; diarrhea; rectal bleeding; yellowing of your skin or eyes; and dark urine), bone and muscle problems (back pain, join pain, broken bones and muscle weakness), hearing problems, vision problems, lipid problems (fats and cholesterol in blood), serious allergic reactions, blood sugar problems, decreased red and white blood cells, and more. Beyond wondering why this drug is even on the market for safe use, the FDA has made birth control mandatory before a prescription for the drug will be given.

While the intention of the FDA to decrease the instance of birth defects must have been made with good intentions, they are effectively promoting bad health care. They are seeking to avoid a potential pregnancy of a child who potentially will have a birth defect. They are also reinforcing the idea that a child with a disability does not have the right to be born. While the 13-page Patient Introductory Brochure insists that if a woman becomes pregnant while one the drug, she must discontinue use of the drug, it is implied that the pregnancy will be destroyed through abortion.

It is key to note that the package insert for Accutane and the Prescriber's Guide list complete abstinence as an option for preventing pregnancy when using the drug, but it is not mentioned in the Patient Introductory Brochure in any way. In fact, the word is not even mentioned in the Patient Introductory Brochure.

The Prescriber's Guide says the following:

"Before beginning treatment of female patients of childbearing potential with isotretinoin and on a monthly basis, the patient will be counseled to avoid pregnancy by using two forms of contraception simultaneously and continuously one month before, during, and one month after isotretinoin therapy, unless the patient commits to continuous abstinence."

"For this program, all female patients of childbearing potential must fully commit to pregnancy prevention. Abstinence without appropriate contraception is not recommended for patients in the iPLEDGE program who are or have been sexually active. Abstinence may be appropriate when it is a lifestyle choice (e.g., religious practice) and not just a social circumstance (e.g., not having a current partner). If, after counseling, a sexually active patient chooses abstinence without contraception, she must understand that isotretinoin is not recommended for any female patient of childbearing potential who cannot or will not follow the contraceptive requirements of the iPLEDGE program. All female patients of childbearing potential must receive contraception counseling."

There are many issues with the iPLEDGE program that deserve more thorough consideration, however I encourage readers to look into this program and explore the ways that our tax dollars are spent in the name of health. From the scary list of side effects to the coercive contraception policy, it looks like it is time to remove Accutane from the market and to seek a real solution to acne, not a solution that leads to further medical risk.

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