Throughout history physicians and pharmacists have prepared,
or compounded, drugs from raw ingredients. Some pharmacists
still do.
http://www.quackwatch.com/01QuackeryRelatedTopics/compounding.html
Legally in the US pharmacists can presemtly compound drugs
that are made from substances that are on what is called
a bulk drug list. In the early part of 1999 I was asked to
present written and oral testimony to an FDA advisory committee
on pharmacy compounding that was considering adding Mild
Silver Protein (MSP) to the bulk drug list. Compounding pharmacists
had proposed that it be added for "ophthalmic
use". However, had it been
placed on the list, it could have been used for any indication.
In other words, its use would not have been restricted to
the eyes alone.
For more information go to the Federal Register:
http://www.access.go.gov/su_docs/aces/aces140.html
Check off "1999" and "proposed rules" in
the appropriate boxes.
Use "pharmacy compounding" as the search term.
Include the " ".
Two hits come up. Click on:
TEXT under "List of Bulk Drug Substances That May
Be Used in Pharmacy"
I submitted written comments to the committee http://homepages.together.net/~rjstan/msp.html and also attended the two day meeting in Rockville, MD at
which they heard oral testimonies on the drugs being considered
for placement on the list from the compounders, the public
and other interested parties. MSP was considered on the second
day.
Both an FDA ophthalmologist and I gave oral presentations
on MSP. In concluding my talk I asked the compounders if
they were ignorant like my MD,quacks like my pharmacist or
if they had evidence that I hadn't seen. If so I wanted to
see it. In fact, I told them that if they could demonstrate
to my satisfaction that ingesting silver is benefical for
something and that the benefits outweigh the risks I will
endorse it and also support their request to have it added
to the bulk drug list. There was no response. To date no
one has shown me or the FDA any evidence indicating that
ingesting silver in any form, amount or particle size benefits
anyone other than the quack who sells it.
The compounders had a non-voting representative on the committee
who had attended the session on the first day when he and
his colleagues saw me in person. Since committee members
had received my written comments in advance, I believe that
their non-voting representative had seen them and guess that
he must have shown them to his colleagues as well.
Another of the compounders' representatives gave oral presentations
explaining their reasons for requesting that various individual
substances be added to the list. She was scheduled to give
just such a presentation on MSP but didn't show up until
after the FDA doctor and I had given our presentations and
the vote had been taken.
The committed voted unanimously not
to add MSP to the list of drugs that pharmacists are permitted
to compound. Their non-voting rep didn't show up at all
the second day. He never heard my oral presentation although
he may later have heard a recording of it since I believe
that there was at least one compounder in the audience
taping it.
After my talk, a committee member asked who had proposed
MSP for the bulk list. The answer was IACP, the International
Academy of Compounding Pharmacists. It had been their rep,
Gina Ford, who had been scheduled to speak but who hadn't
appeared until after all the testimony had been presented
and the vote had been taken.
Larry Sasich, the Parm. D from Public Citizen, was present
for the meeting on the first day. He gave an oral presentation
in which he pointed out that a visit to one of the compounders'
websites contained links to some of the worst quacks in
medicine. When PC requested more information, they were
sent similar material snail mail.
These are the compounders webpages:
http://www.thecompounders.com/
http://www.ijpc.com/
http://www.iacprx.org/
Check them out for yourselves.
The committee also voted unanimously not to permit hydrazine
sulfate to be added to the bulk list. HS & MSP are also sold legally as unregulated dietary supplements.
http://homepages.together.net/~rjstan/rose14.html
While I was in Rockville attending the meeting, FDA gave
out more pink slips. More budget cuts. Fewer employees.
Less protection for Americans.