[acb-diabetics] metformin in new form

Wed Jan 30 18:56:35 EST 2013

This just makes me wonder about the pharmasudical lobbiests and the
kickbacks they are getting. Considering that Metformin is trued and tried,
you have to wonder why people have to pay so much for health care and
prescriptions. I have these issues mentioned in the article with Metformin,
and it's a pain in the ...

So, why do so many people think we have the best health care around when it
has so many restrictions? If this is the case with Metformin, I wonder how
many other drugs may be held back that could assist persons with Diabetes.

Ken Metz

From: acb-diabetics-bounces at acb.org [mailto:acb-diabetics-bounces at acb.org]
On Behalf Of Patricia LaFrance-Wolf
Sent: Wednesday, January 30, 2013 3:52 PM
To: Acb-Diabetics at Acb. Org
Subject: [acb-diabetics] metformin in new form

From: Diabetes Self-Management
Sent: Wednesday, January 23, 2013 4:35 PM
Subject: Metformin Without the Misery

By David Spero

What if you could get all the benefits of metformin, but without the
abdominal pain, diarrhea, gas, and vomiting that this medicine often brings?
Well, such a treatment exists, and it works. Why hasn't it come to market?

A group of enterprising osteopaths and pharmacists at Scarbrough
Pharmaceutical Innovations, LLC, in Akron, Ohio, have patented a transdermal
metformin (TDM) formula, or metformin that absorbs through the skin. The
prescribed dose is squeezed out of a syringe and rubbed into the skin,
although it could also be made into a skin patch. One of these osteopathic
doctors, Jay Shubrook, DO, has been good enough to explain the issues to me.

TDM has the same benefits as oral metformin. It lowers insulin resistance,
prevents dumping of glucose by the liver, encourages weight loss, and treats
polycystic ovary syndrome (PCOS.) 

This could benefit millions of people. Whenever I or others write about
metformin on this site, we get dozens of comments, equally divided between
"This drug is wonderful," and "This drug is awful. It tore up my stomach."
Many people can't take it, or it makes their lives miserable. 

The Ohio researchers prepared and tested a mix of four different "polymers,"
or gels that can deliver metformin through the skin into the blood.
According to their patent application, 

One advantage of using transdermal metformin is its ability to bypass the
gastrointestinal system. This allows the drug to not have the
gastrointestinal side-effects associated with oral metformin. 

Another unexpected benefit is that metformin seems to be absorbed through
the skin much more effectively than through the digestive system.
Apparently, 50% to 90% of oral metformin is degraded in the intestines and
brings no benefit. According to research, a person taking 1500 milligrams
(mg) per day of oral metformin can probably get the same benefit with a
daily dose of 100 mg of TDM, delivered in two separate doses of 50 mg each. 

So why isn't this drug available? TDM's inventors are "compounding
pharmacists." Food and Drug Administration (FDA) rules for compounding
pharmacies forbid them from acting as manufacturers. They are only allowed
to create compounds suited to an individual person's needs, according to
specific doctor's order. They can't make a product that any pharmacy can
stock and provide.

Compounding pharmacists are extremely valuable. They can make drugs that
corporate pharmaceutical companies don't find profitable enough to make. 

But these rules can cause strange situations. I used to take a multiple
sclerosis drug called 4-AP that helped me walk better. It wasn't FDA
approved, but a compounding pharmacist could make it up with a doctor's
order, for about $12 a month.

Thousands of people benefited. Most doctors wouldn't prescribe it, though.
As with TDM, they hadn't even heard of it. Finally, a drug company got
involved and did the extensive safety and effectiveness research for drug
approval. It's now called Fampridine. Any neurologist will prescribe it, but
it costs about $400 a month, so many people can no longer afford it!

The Ohio osteopaths have a patent on their TDM formula, but it's not FDA
approved. According to the FDA, "Generic drugs are required to have the same
active ingredient, strength, dosage form, and route of administration as the
brand name product." Since there is no brand name TDM, it may be that some
drug company will have to undertake the safety and efficacy research any new
drug must go through. If that happens, TDM might become available, but only
a long time from now, and at a very high cost.

Why should any of that be necessary, when we already know metformin is safe
and effective? We're just changing the route to protect our stomachs.

Most doctors know nothing about TDM, and many will be rightly concerned
about not understanding the lower doses needed. Some will not take the time
and effort to consult with a compounding pharmacist. But if you're a person
who hasn't tolerated oral metformin, you might be able to find a doctor who
will order TDM for you, and a pharmacist who will compound it.
Unfortunately, since it's not FDA approved, it probably won't be covered by
insurance. People I have talked to are paying about $60 a month for two
doses a day. 

At this point, no drug company is likely to take on the expense and effort
to get TDM approved. The profit margins aren't high enough. The Ohio
pharmacists are working on it; so might be a company in India, but with
their lack of resources, it will take many years to get approval, if they
ever do. 

I think it's up to us to demand that FDA fast-track TDM. We should write to
the American Diabetes Association, the FDA, the PCOS Foundation, the
American Association of Clinical Endocrinologists, and everyone else we can
think of, demanding that resources be put into this drug, which we already
know works and which could save millions from misery.

If you want TDM now, find a compounding pharmacy that will make it up for
you, like Scarbrough Pharmacy in Ohio (the inventors.) Or someone closer to
home. Then talk to your doctor about ordering it. 

If desired, the pharmacist will work with your doctor. Dr. Shubrook says "We
look at the clinical glucose response. We order a comprehensive metabolic
profile as well but have never seen problems with this." 

Roughly 100 to 200 mg a day in divided doses might be a good place to start,
but ask your doctor about that, after showing him some of the papers linked
in this article. 

------------------------

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