The FDA continues its war on the compounding of custom medications by eliminating even more dietary ingredients.
Action Alert!
Curcumin is the most important ingredient of the Indian herb turmeric. You probably have it in your kitchen as a yellow spice.
From
a health standpoint, this herb is a miracle. It is tremendously
anti-inflammatory and has so many health benefits it would take a book
to list them all.
Naturally the drug industry wishes it could be
patented as a drug. That won’t happen, because natural foods generally
cannot be patented. FDA to the rescue! The agency has just ruled that
curcumin cannot be used in a compounded medication—that is in a
medication prepared just for you by a specialized pharmacy.
That
at least knocks out one source of competition for standard
anti-inflammatory drugs. And the agency doesn’t seem to care that those
same standard anti-inflammatory drugs have been shown to be dangerous.
Unfortunately, it isn’t just curcumin that has been banned.
A few months ago, we noted that the FDA’s Pharmacy Compounding Advisory Committee (PCAC) was a
stacked deck, and recent developments unfortunately prove this observation correct.
At
its most recent meeting, PCAC voted on whether to include nine
substances on the list of bulk drugs that may be compounded under
FDA regulations
following the passage of the Drug Quality and Security Act. Of these
nine substances, only one was approved. We listened in on the meeting
and noted that, for a majority of the substances, the committee just
adopted the FDA’s recommendation.
Among those that were rejected,
curcumin stands out—but so does MSM, another almost magical
anti-inflammatory with few if any side effects. There are others as
well. Here is a short rundown of the major supplements and drugs that
the Committee voted to ban:
Curcumin
Despite
robust clinical evidence
that curcumin is safe, with superb and well demonstrated
anti-inflammatory characteristics, PCAC voted to not allow curcumin onto
the FDA’s bulk drug list.
One of the reasons stated for voting
not to include curcumin was that it could still be acquired as a dietary
supplement. This entirely misses the point of compounded medications
and individualized medicine!
Compounded medicine is for segments
of the population that have special needs and require nutrients to be
delivered in specific ways—for instance, smaller pills, or gluten-free
pills, or time-release capsules, or creams that are not offered
commercially. Compounding pharmacies are the only way these patients can
get access to the nutrients and medications they require. Stating that a
substance can still be obtained in supplement form betrays what we
suspected all along—that many members of PCAC do not understand what
compounding is or why it is important.
Nor is this all. When the
FDA grants a monopoly to a drug company to make a drug, it comes in a
one-size-fits-all form—which is sometimes completely wrong for the
substance. For example, some hormones should never be delivered in pill
form: they are destroyed in the intestinal tract or taken out by the
liver before they can do you any good. These particular hormones should
only be delivered by cream, which compounding pharmacies can create. But
drug companies couldn’t care less about the needs of individual
patients, because they want to sell pills.
Methylsulfonylmethane (MSM)
MSM is a
natural sulfur compound
found in fruits and vegetables. Studies have shown that MSM reduces
pain related to arthritis with no significant side effects. It also can
stop even the most severe allergies in their tracks. If you suffer from
seasonal allergies, this substance could be exactly what your body needs
to stop it.
Could PCAC and the FDA be trying to clear the market
for Big Pharma’s arthritis drugs? Why else would they vote to eliminate
this natural substance from compounding?
Deoxy-d-glucose
This substance
has exhibited
anticancer and antiviral properties, but there is no mystery as to why
it was voted down. It is currently being studied by a drug company as a
possible drug, so the FDA is no doubt protecting the pharmaceutical
company looking into the substance.
Glycirrhizin
Integrative doctors we spoke with use this as an antiviral agent,
especially for hepatitis. It does have to be used carefully under medical supervision, but in this case has been banned from prescribed medical use.
Domperidone
This drug has been
useful for treating gastroesophageal reflux disease with minimal serious side effects.
This is only the latest assault on compounding. Last month
we reported
that a number of bioidentical hormones had been nominated to the
“Demonstrably Difficult to Compound” list, an attempt to further limit
the substances that may be compounded under current law.
By using
bogus reasoning to whittle down what ingredients can be used in
compounding, the FDA is once again doing the bidding of the very
companies the agency is supposed to be regulating—and thereby preventing
consumers from getting the medications they need.
Action Alert! Write to the FDA and urge them to reconsider their rejection of these ingredients to the bulk drug list.
Please send your message immediately.
Other articles in this week’s Pulse of Natural Health:
New Research BANNED on Medical Food and Supplements?
The
recalled product was shipped between July 13 and July 17, 2015 and
distributed to retail stores only in Maryland. No other K-9 Kraving Dog
Food products are affected by this recall.
Veterinarians
and the government are reminding pet owners that these treats are not
necessary to a pet’s nutrition or health. Safety advocates have been
asking the government to ban these imported treats for years, but
nothing has been done.
