The FDA vs. Compounding Pharmacies: a Case of Blinders and Bias

All of you who follow our page have been impacted by our compounding pharmacy or are curious about what compounding can provide to you.  Let me first define what compounding is.  Compounding is making small batches of medication for personalized care for their patients.  When you bring us your prescription we make it for YOU.  Personalized medications sound like a luxury, however, we believe it is the right of every patient to receive personal medical treatment because every patient is an individual.  Whether it is for patient comfort, pain management, dosage form, hormone replacement, or any other need that you and your physician decide is necessary we believe you have the right to receive the purest and safest treatment available.  There are many medications that can be purchased from large manufacturers that are perfectly reasonable as one size fits all product, but when you need something special, that’s what compounding pharmacies, like us, are for.

In the past couple of decades compounding pharmacies have been under attack by the FDA.  The FDA and compounding pharmacies are supposed to be separated unless the medications that compounding pharmacies are using are found to put the public at risk.  Drug companies can only produce medications if allowed by the FDA after they have supplied years of work and evidence proving that the drug is effective and safe.  In this way the FDA’s job is clear and VERY important.  The beauty of compounding is that we are not limited to studies here in the United States.  Many compounds are based off of old medications and combinations that have simply been “grandfathered” and do not have any profit benefit for large pharmaceutical companies.  Other compounds are based off of other studies that have not been submitted to the FDA and other studies are from other parts of the world, like Europe.  By no means are the treatments we use in compounding pharmacies snake oil or hocus pocus.

I’m not really a huge fan of conspiracy theories.  I am a pharmacist.  I like evidence based medicine.  I like evidence in general.  I cannot say whether the FDA is just loving the money they are getting from the large drug manufacturing companies (often called Big Pharma) or if they are just so closed minded to evidence that is from other libraries other than their own.  Imagine the ignorance of an individual who considers only what is contained in their personal library the truth.

 I remember when I was are pharmacy student a man from the FDA came to us and was telling us how there is no evidence for estriol use or Bio-Identical hormone replacement.  Lori was my boss, but she was also my teacher and I asked him about other studies that were being done in the United States and other countries showing the benefit of compounded hormone replacement therapy.  I asked why the FDA thought that women’s hormones were one size fits all and, if they really thought it was best to have the lowest doses for hormone replacement therapy why they had a problem with compounding, which uses micrograms dosing and allowed the makers of Premarin to continue to use 1mg (1000 micrograms) for menopause symptoms.  I received no answer.

The FDA has been trying to stop the usage of estriol by compounding pharmacies for almost a decade, but they have been unable to succeed because they cannot find anything unsafe about the product used in our compounds.  In fact, the FDA is looking over the approval of a new medication for the use of Multiple Sclerosis.  The drug?  Estriol.  Estriol 8mg (again, compounding pharmacies use micrograms)!  So why are they trying to remove it from compounding pharmacies, but allowing a large pharmaceutical company to use doses a thousand times larger than what is used in compounding?  The numbers aren’t adding up, but it definitely looks like the FDA is trying to protect Big Pharma from compounding pharmacies creating knock-off products.  By the way, it is illegal for compounding pharmacies to do this.  The only time we can make a product similar to a manufactured product is if the product is not available or if, for some reason, the available product is not suitable for the patient for some reason (allergies, etc.).  Reputable compounding pharmacies do NOT create knock-offs.  Our business is in custom products for our patients.  Of course the humor and sadness in all this is “who is more afraid of who?”

The FDA continues to selectively warn against compounding pharmacies.  Especially our work with hormone replacement therapy.  The odd thing is that the FDA hasn’t updated its site on compounding in five years.  So much has happened and been discovered in 5 years (the breakthroughs in male hormone replacement and in estriol), but the FDA site still states:

“Some pharmacies promote hormone therapy for men in the form of testosterone to treat a decline in the level of testosterone in older men, sometimes referred to as andropause. There are currently no FDA-approved products for the treatment of andropause. In addition, there are no FDA-approved testosterone drugs for women.”

Of course, now we have the product Androgel… Which the FDA was approving when this site was last updated… awkward.  The site also states that it has tested hormone medications from 29 compounded drugs and all of them were found to fail and only 2 compounds had some hormone in them.  Wait?!  Compounding pharmacies are trying to rip you off?!  No.  If you read the survey the FDA ordered these compounds from 12 online pharmacies.  Wait a dang minute?  A compounding pharmacy that you can order medication from online?  Most pure online compounding pharmacies are questionable.  I mean, if you look inside your email’s spam box right now there are tons of online pharmacies telling you medications are available without prescriptions.  They are a scam!  You cannot order compounds from us over the internet.  You need a prescription.  You may

RENEW your prescription via our website (because we’re fancy like that).  The FDA took a biased sample.  All of our raw materials are tested for purity and provided to us by reputable wholesalers.  We take GREAT pride in our compounding practices.  Our pharmacy is actually a teaching pharmacy for multiple universities including the University of Arizona, Midwestern University in Glendale, and the University of New Mexico.  We follow all purity and safety standards.  Why?  Because we like to protect our patients and our staff.  It pays to do things the right way.

Clearly this is a subject that is near and dear to our heart and we hope that it is important to you too.  In fact, I encourage you to do your research and ask questions.  Whether you are our patient or looking for a good compounding pharmacy you have the right to research and ask questions.  We are here to guide you to the right treatments for you, whether compounded or manufactured.  Here are the links to the FDA websites that I quoted:

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm183088.htm

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm155725.htm

We encourage you to also subscribe and become a member of our cause by subscribing to the Alliance for Natural Health:

http://aahf.convio.net/site/PageServer?pagename=page_not_found

And please read this recent article on the newest attack against compounding pharmacies, which could put thousands of small pharmacies out of business:

http://www.anh-usa.org/compounded-medications-even-more-at-risk/

 

2 thoughts on “The FDA vs. Compounding Pharmacies: a Case of Blinders and Bias

  1. Hello there! I could have sworn I’ve been to your blog before but after browsing through some of the posts I realized it’s new to me. Nonetheless, I’m certainly happy I stumbled upon it and I’ll be book-marking it and checking back often!

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