FDA trying to drastically curtail compounded medicines

[Kofi]

There is an effort underway at the FDA to reclassify compounding
pharmacies and place them under inspection regimes that are impossibly
expensive to meet. I urge you to visit the trade association
<http://www.iacprx.org/> and get involved if you want to continue to
have access to vitamin shots in your doctor's offices and the full
spectrum of care at E.R.'s.

The end result of the FDA's current proposals will be that many states
will no longer be served at all by compounders. Patients will lose
access to sterile injections of simple compounds like methylcobalamin,
which is used to treat neuropathy, dementia, atherosclerosis, nitrous
oxide poisoning, inflammatory bowel disease and many other conditions.
Oral surgery and in-office medical procedures will be drastically
curtailed. It may even become impossible to provide prompt treatment
for certain chemical spills. Even nursing homes will be affected.

This is not being done in the name of patient safety, which is obvious
once you read the first draft of the new rules; hospitals will be
completely exempt from these regulations. It looks like a bunch of
lobbyists are exploiting a tragedy (New England Compounding) to corner
the market and force patients who use cheap, effective, low-risk
treatments (e.g., methyl-B12 or vitamin D3) produced by competitive
businesses into using expensive, proprietary and risky drugs (e.g.,
Gabapentin and Lyrica).

Hospitals typically do not compound for patients, they have little to no
expertise at it and most of them have no desire to enter a low-profit
business like this. It's also the case that a wave of mergers over the
last twenty years has left most metropolitan areas with hospital
monopolies who are insulated from any competition and have ridiculous
pricing power. Patients will be paying more and getting a lot less - if
they can get it at all. Many hospitals may never choose to enter this
low-margin business.

Some of the treatments you could lose include hypoallergenic low-dose
naltrexone, antifungal and antibacterial nasal sprays, hypoallergenic
cough syrups, topical anesthetics for outpatient surgical procedures,
vitamin and mineral shots, topical creams for impotence and salves for
exotic chemical burns. This will affect everyone from autistics to
octogenarians.

I know all-too-well what the victims of New England Compounding
suffered. I was poisoned as a result of FDA inaction. One of my
mercury fillings cracked and leaked, leaving me autoimmune. I was also
on Vioxx at one point - which we now know not only causes deadly
cardiovascular complications but, as a COX-2 inhibitor, is quite
inappropriate for autoimmune patients (Regulatory T-cells depend on
COX-2 to function). If the FDA really cares about patient safety, they
could stop the advertising of Celebrex to rheumatoid arthritis/Crohn's
patients and promulgate rules preventing autoimmune patients, diabetics,
bruxers or other vulnerable populations from ever being exposed to
amalgam fillings.

I will not hold my breath waiting for them to do the right thing.

I never had any desire to go on opiates or Gabapentin to treat my
chronic pain. I took the most conservative approach possible based on a
deep, personal reading of the neuropathy literature. I can't help but
feel like I'm being punished for being so responsible in my pain
management.

It is possible to have effective quality control of these facilities but
the FDA regulations do not appear to be designed with that goal in mind.
The public window for comments is rapidly closing. Please take action
before it is too late.

Feel free to circulate this open letter to any and all affected parties.

Kofi Anon