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!

Second Opinion Is Not Enough In Medical Cases

What Is A Second Opinion?

Just asking another specialist in the same medical field before making a critical decision? Is this enough?

Why not ask for a third opinion? Your life or your future well being or your remaining life expectancy may depend on it. Don’t hesitate!

Common Sense Falls Short

Physicians are so specialised that they either do not know or they ignore what is going on in neighboring disciplines/specialties although it might be very relevant to your medical condition.

Second, a physician of one field will usually hesitate to advise on other medical fields not least to avoid future liabilities or reprimands from his own profession. This is a serious shortcoming of our medical profession!

Beyond Second Opinion

It appears to be highly recommendable to instruct doctors what procedures you want to have done before any major treatment where the patient may be incapacitated to decide.

Do Your Homework!

With the Internet today, there is no excuse not to do a comprehensive research about your medical condition.

Be prepared for your next doctor’s appointment.

Choose a specialist from another discipline if your research leads you in this direction.

An Example

For illustrative purposes and for brevity sake, I will keep it very simple.

If you have a fibroid and you visit a gynecology doctor who is also a surgeon, this doctor will most likely recommend a myomectomy. This is a standard treatment which has been applied over many years.

If you have a fibroid and you visit a radiologist, this doctor will likely recommend a uterine artery embolization (a.k.a. uterine fibroid embolization or UFE). This is a fairly new treatment which could still be perceived as being rather experimental and it somewhat still lacks long term track record.

If you choose the myomectomy you may wake up with a hysterectomy performed instead, because during the actual surgery the doctor had to make last moment decisions based on new discoveries. Hence, it is recommendable to instruct the surgeon to desist from a hysterectomy, because it is irreversible.

If you choose the UFE, a myomectomy could still be performed later, if the UFE was not effective or the UFE could be repeated.