[Diabetes-talk] Fwd: FDA tells companies tostopthe illegalmarketing of treatments for diabetes

Fri Jul 26 23:34:04 UTC 2013

Good evening, folks, Bill Lewis here again.
I notice that the government's letter about otc and herbal remedies is 
viewed from several perspectives which I certainly must acknowledge. 
Although I want desperately for somebody to do a better job of supervision 
over the vast OTC market, I don't want the "baby washed down the drain with 
the bathwater either."  That's the problem.

For example, remember my experience with the herbal compounds that I take 
for the neuropathy?  Well, the prescription drug I took for several years 
that was supposed to help the neuropathy actually did very little.  But 
right now, after taking these herbal cablets twice a day for four months, 
neuropathy is still almost unnoticeable.  I notice that the tingling comes 
back, when my glucose numbers are over 200 but it goes away again, when I 
get the numbers back down 50 or so points below 200.  So, I guess that means 
I am still impressed with the stuff, because it works.  However, I found 
out, though, that there are several different types of and causes for the 
neuropathy, and that requires different combinations of treatment 
modalities.  Therefore, I can't generalize about all the different choices 
available on those store shelves.  So, stay scientific and try to examine 
the data and trust known experts in the field.  For instance, my level of 
trust in my podiatrist has gone up since he suggested the herbal approach 
for me right now.

What I am most concerned about regarding the current government 
explo9rations is I know what their plan is.  They want to remove any 
competition to the pharmaceutical business philosophy of "charge what the 
market will bear," and they do.

Do any of you remember an article a year or so ago in these pages about the 
real cost of medicines?  Remember that the markup on prescription meds was 
as high as 5000 percent?  Remember that CVS pharmacies was the only company 
that charged somewhat more reasonably, according to actual cost.  I have not 
yet checked them out here in Wichita since they recently opened a store 
here, but I will be doing so soon.

The pharmaceutical companies charge American citizens billions of dollars 
each year more than they do their overseas markets; and European drug 
companies sell their prescription drugs many percentage points less than 
American companies do for what we get here.

So, as I said before, try to compare data and products; get a broomstick and 
hang a lantern on one end and carry it over your shoulder and keep looking 
for a honest man.  "Cheers!"

-----Original Message----- 
From: Bridgit Pollpeter
Sent: Thursday, July 25, 2013 12:42 PM
To: 'Diabetes Talk for the Blind'
Subject: Re: [Diabetes-talk] Fwd: FDA tells companies tostopthe 
illegalmarketing of treatments for diabetes

I would say it's a matter of perspective. Depending on life
circumstances, you will view comments like Bill's differently.

Regardless of the FDA and drug companies, I don't think anyone would
argue that drugs exist on the market, *natural* or synthetic, that
promise results that are not accurate or completely fabricated. My mom
for years has pushed me to try some natural treatment for diabetes that
would allegedly allow me to not use insulin. I've always been skeptical
of such treatments and never tried it. Fortunately she wasn't aware of
the so-called treatment until I was completely managing my diabetes
independently. Who knows if she would have tried it when I was a child.

So while I have opinions about the FDA, many drugs and treatments still
exist that are probably more harmful than helpful.

And I took this on a tangent, grin.

Bridgit

-----Original Message-----
From: Diabetes-talk [mailto:diabetes-talk-bounces at nfbnet.org] On Behalf
Of Tamera
Sent: Thursday, July 25, 2013 10:34 AM
To: 'Bill Lewis'; 'Diabetes Talk for the Blind'
Subject: Re: [Diabetes-talk] Fwd: FDA tells companies to stopthe
illegalmarketing of treatments for diabetes

Bill, I completely agree with your comments!
Tamera

-----Original Message-----
From: Diabetes-talk [mailto:diabetes-talk-bounces at nfbnet.org] On Behalf
Of Bill Lewis
Sent: Wednesday, July 24, 2013 10:14 AM
To: Diabetes Talk for the Blind
Subject: Re: [Diabetes-talk] Fwd: FDA tells companies to stop the
illegalmarketing of treatments for diabetes

Hello Mike,  Thanks for passing this letter to us, but I want to call
your
attention to some facts about what this letter is really about.  Read on

carefully!

In the letter near the bottom, notice that they openly state that they
have
had no data showing injury or death as a result of these OTC products.
Doesn't that say something to you?

The government, in case you have not heard already, is trying to find a
way
of driving the alternative medicine market out of business, leaving us
only
with Obama Care.

Remember back, Mike, to 1993 when Hillary Clinton tried to ram her
Hillary
Care down our throats?  It came to light that her blue ribbon committee
that
wrote her health care plan did not actually exist.  Her claims about the

plan's benefits were conspicuously wrong.  And in the plan, she had a
section that prohibited patients from paying for medical care privately,
for
penalty of prison and/or huge fines, which included the doctors who
cooperated in an effort to provide private care.  Remember?

This letter from the government--once again, looking at the person
signing
the letter and her official rank and department and you will see that
she is
one of the parties that Obama set up with immunity and with instruction
to
bad-mouth the alternative med industry out of business.  True, there are

some companies and products on the OTC market that are scams, but there
are
many others that are legitimate.  The OTC vitamin market, the basic herb

markets, and others.  So, Mike, be careful.  Read any government, or
otherwise, pronouncements very very carefully and pay attention to the
wording.

Contact me if you still are uncertain about this government-issued
letter.
I personally am skeptical about herbs and such, but I sure as heck am
not
going to let this particular government turn our country into a banana
republic or our health care system into a sshameful excuse for health
care
that is affordable and effective.

Your friend -- yes, you are my friend; because I ain't going to let
nobody
tell me how to pick my friends!

Bill Lewis
<billlewis31 at cox.net>

-----Original Message----- 
From: Mike Freeman
Sent: Tuesday, July 23, 2013 10:16 AM
To: Diabetes Talk for the Blind
Subject: [Diabetes-talk] Fwd: FDA tells companies to stop the
illegalmarketing of treatments for diabetes

Begin forwarded message:

> From: FDA NEWS FOR HEALTHCARE PROFESSIONALS
> <NewsHealthCareProfs at fda.hhs.gov>
> Date: July 23, 2013, 7:12:10 PDT
> To: FDA NEWS FOR HEALTHCARE PROFESSIONALS
> <NewsHealthCareProfs at fda.hhs.gov>
> Subject: FDA tells companies to stop the illegal marketing of
treatments
> for diabetes
>
> Dear Colleagues,
>
> The U.S. Food and Drug Administration is taking action to remove from
> the
> market illegal products, including some labeled as dietary
supplements,
> that claim to mitigate, treat, cure or prevent diabetes and related
> complications. The agency recently issued letters warning 15 companies

> that the sale of their illegally marketed diabetes products violates
> federal law. The letters were sent to foreign and domestic companies
whose
> products were sold online and in retail stores.
> The FDA is advising consumers not to use these or similar products
because
> they may contain harmful ingredients or may be otherwise unsafe, or
may
> improperly be marketed as over-the-counter products when they should
be
> marketed as prescription products. Using these products could cause
> consumers to delay seeking proper medical treatment for their
diabetes.
> FDA-approved diabetes treatments, prescribed by a licensed health care

> professional and shown to be safe and effective, are readily available
for
> people with diabetes.
> "Diabetes is a serious chronic condition that should be properly
managed
> using safe and effective FDA-approved treatments," said FDA
Commissioner
> Margaret A. Hamburg, M.D. "Consumers who buy violative products that
claim
> to be treatments are not only putting themselves at risk but also may
not
> be seeking necessary medical attention, which could affect their
diabetes
> management."
> Nearly 26 million Americans have diabetes, a disease in which blood
> glucose or blood sugar levels are high, resulting from the body's
> inability to produce sufficient amounts of insulin or to effectively
> utilize its own insulin. There is a greater risk for serious health
> complications, such as heart disease, blindness, kidney failure, and
> lower-extremity amputations, if diabetes is not managed appropriately.
> "The FDA is committed to protecting consumers from the dangers of
these
> illegally sold products," said Howard Sklamberg, director of the
Office of
> Compliance in the FDA's Center for Drug Evaluation and Research. "We
will
> continue to take aggressive action against firms that sell illegal
> products claiming to treat diabetes."
> Many of the illegally sold products that are the subject to this
action
> include claims such as "prevents and treats diabetes," and "can
replace
> medicine in the treatment of diabetes." In addition, some of the
products
> may cause harm because the products contain undeclared active drug
> ingredients or may not have been manufactured and handled according to
FDA
> quality standards.
> These illegally sold products include:
> Products sold as "natural" treatments for diabetes, but containing
> undeclared active pharmaceutical ingredients in unknown quantities
that
> could cause harm or complicate medical conditions;
> Dietary supplements and ayurvedic products (medicine of the healing
arts
> that originated in India) with claims to treat, cure, and/or prevent
> diabetes;
> Unapproved drugs sold over-the-counter, including some homeopathic
> products, intended to treat complications associated with diabetes,
which
> include relieving symptoms caused by nerve damage in the arms and legs

> (also called peripheral neuropathy); and
> Prescription drugs for diabetes sold by online pharmacies without a
> prescription.
>
> The FDA has requested a written response from these companies within
> 15
> business days stating how the companies will correct the violations.
> Failure to promptly correct the violations may result in legal action,

> including product seizure, injunction, and/or criminal prosecution.
> To date, the FDA is not aware of any reports of injury or illness
> associated with the illegally sold products but is taking action to
> protect the public health from potential harm related to these
violative
> products. The FDA asks health care professionals and consumers to
report
> any adverse reactions to FDA's MedWatch program either by:
> completing and submitting the report online at
> www.fda.gov/medwatch/report.htm2; or
> downloading and completing the form3, then submitting it via fax at
> 1-800-FDA-0178.
>
> For more information:
> Warning Letters4
> Cyber Letters5
> Illegally Sold Diabetes Products6
> Consumer Update7
>
> We thank you for your continued support of our mission.
>
> Best regards,
>
> Helene
>
> Helene D. Clayton-Jeter, OD
> Cardiovascular and Endocrine Liaison Program
> Office of Health and Constituent Affairs
> Office of External Affairs
> Office of the Commissioner
> U.S. Food and Drug Administration
> 10903 New Hampshire Avenue
> Bldg 32, Room 5341
> Silver Spring, MD  20993
> Phone:  301-796-8452
> BB:  240-753-3939
> Fax:  301-847-8623
> Email:  helene.clayton-jeter at fda.hhs.gov
> Diabetes Information
> Cardiovascular Information
>
>
> THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS
> ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED,
CONFIDENTIAL,
> AND PROTECTED FORM DISCLOSURE UNDER LAW. If you are not the addressee,
or
> a person authorized to deliver the document to the addressee, you are
> hereby notified that any review disclosure, dissemination, copy or
other
> action based on the content of this communication is not authorized.
If
> you have received this document in error, please immediately notify us
by
> e-mail or telephone.
>
>
>
>
>
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