Patient Versus U.S. Food And Drug Administration

Introduction

For various reasons, I am of the opinion that the FDA should be shut down and completely reorganized as far as medicine is concerned.

To keep this post brief, the FDA has been a serious mistake of big government overreach and socialist approach to medicine. It is a prime example of unconstitutional paternalism in the U.S.

Ulipristal Acetate

For brevity sake, I will not go into details of this mediation here, but see e.g. here.

To my knowledge this fairly new medication is currently only approved by the FDA as an emergency contraceptive.

In Europe and in Canada (since July 2013) it is approved as a pre-operative treatment of fibroids. This medication appears to have excellent outcomes as far as shrinking of symptomatic fibroids and reducing heavy bleeding because of fibroids is concerned. Especially also in cases with multiple and large fibroids.

Thus, women in the U.S. may still have not much choice but to undergo surgical procedures like myomectomy and or hysterectomy, even so this pill can potentially help many women to alleviate their symptoms. Sure their is also morcellation, laparoscopy, uterine artery embolization, and focused ultrasound available.

Instead a woman in the U.S. would currently have to travel to Canada to obtain this treatment.

Big Government In Cahoots With Medical Profession Retard Progress

I am not a doctor, but it is my impression that this medication would be a great alternative for premenopausal women who would either have to undergo hysterectomy or pop ulipristal acetate containing pills for three months every day.

It appears that this pill has lasting effects on the shrinkage of the fibroid even up to six months after ceasing to take the pills. I believe, in the U.K. doctors are allowed to prescribe two regimens of three months total, in Canada only one three months regimen.

So why exactly can a premenopausal women not repeat this treatment until menopause and avoid hysterectomy? I did not come across any compelling warnings in the medical literature!

Why Is The Patient Not Allowed To Decide?

In my opinion, it is absolutely unconstitutional that a big government FDA can deny patients to choose for themselves whether they want to try a medication like this at their own risk and responsibility to improve their quality of life.

This Is Not An Isolated Case

Some people may argue what I presented in this post is an isolated case and dismiss it. I am afraid this is far from the truth.

The fact is that patients are not allowed to override the FDA!