By Dr. Mercola
Diabetes has increased more than 700 percent in the last 50
years. Today, more than
one in four Americans are either pre-diabetic or have
full-blown diabetes.
The conventional treatment route includes a variety of
diabetes drugs, some of which have been found to do far more
harm than good.
Rosiglitazone, sold under the names of
Avandia, Avandamet and Avaglim, is perhaps the most
well-known in this category of unmitigated disasters.
Avandia Part of Worst Drug Fraud in History
This past summer, drugmaker GlaxoSmithKline agreed to a
record-breaking $3 billion settlement over the sales and
marketing practices of several of its drugs, including the
dangerous diabetes drug Avandia. The payment is the largest
fraud settlement in U.S. history, and the largest fine ever paid
by a drug company.
Avandia was found to be profoundly dangerous — a
fact
hidden by GSK for over 10 years, as they knew it would
adversely affect sales1.
This was revealed in a Senate Finance Committee report,
released by Max Baucus and Charles E. Grassley in February 2010.
The report also asked why the FDA allowed a clinical trial of
Avandia to continue even after the agency estimated the drug had
caused an estimated 83,000 heart attacks between 1999 and 20072.
Avandia hit the market in 1999 and quickly became a
blockbuster drug. By 2006 its annual revenue was $3.2 billion. A
year later, a damning study published in the New England
Journal of Medicine (NEJM) linked it to a 43
percent increased risk of heart attack and a 64
percent higher risk of cardiovascular death than
patients treated with other methods3.
This is a steep price, to say the least, for a disease that
does not require drugs to begin with.
There were many articles and reviews published about Avandia
following the New England Journal of Medicine study,
but research from the Mayo Clinic revealed that 90
percent of scientists who wrote favorable articles
about the drug had financial ties to GlaxoSmithKline4.
Unfortunately, a committee of independent experts still
recommended that Avandia remain on the market, despite its
many risks, and a U.S. Food and Drug Administration (FDA)
oversight board voted 8 to 7 to accept the advice.
On September 23, 2010, the FDA restricted access to Avandia5,
but it didn't take it off the market. Under the ruling, the drug
is still available to patients not already taking it, but only
if they are unable to achieve glycemic control using other
medications and, in consultation with their health care
professional, decide not to take a different drug for medical
reasons.
Shockingly, current users of Avandia were told to continue
using the medication if they appeared to be benefiting from it
and they acknowledged that they understood the risks. Doctors
had to attest to and document their patients' eligibility and
patients had to review statements describing the cardiovascular
safety concerns.
Unlike the US FDA,
British regulators ruled that the benefits of Avandia no
longer outweighed the risks, and so, in late September 2010,
they told 90,000 British diabetes patients to stop taking it.
DPP-4 Inhibitors — Another Disastrous Diabetes Drug
Dr. Ron Rosedale, one of my mentors on the importance of
insulin first alerted me to this issue in our recent interviews
we had but are not yet published. This is another potential
disaster-in-the-making, namely that of Dipeptidyl peptidase-4
inhibitors6
(DPP-4 inhibitors), also known as gliptins (specifically,
gliptins decrease the breakdown of glucagon-like peptide-1, or
GLP-1). These belong to a class of hypoglycemic drugs used to
treat type 2 diabetes. DPP-4 inhibitors work by reducing
glucagon and blood glucose levels7
(inhibiting glucagon release results in increased insulin
secretion and decreased blood glucose).
The first drug in this class — Sitagliptin, manufactured by
Merck and sold under the name Januvia8,9
— received FDA approval in 200610.
Saxagliptin (Onglyza), another DPP-4 inhibitor, was approved in
July 2009, followed by Linagliptin (Trajenta) in 2011. A number
of additional DPP-4 inhibitors are currently under development.
I was among the first to publicly warn that another of
Merck's drugs,
Vioxx, would kill thousands from heart disease. The drug
indeed wound up killing over 60,000 people before Merck removed
it from the market in 2004.
To compound this problem even further, Merck has announced
that it has successfully completed a Phase II trial of a
once-a-week version of a DPP-4 inhibitor. In pharma
announcements and in its own company literature, Merck indicates
that the once-a-week version is also being tested in combination
with certain
statin drugs, such as Lipitor and Simvastatin. The reasoning
for these drug combinations is that diabetics fall under the
guidelines of being statin candidates because they have a higher
cardiovascular risk, but 40 percent of diabetics don't take
them.
The idea is to create a combination drug containing both a
DPP-4 inhibitor and a statin. So one drug will radically
increase your risk of cancer, and the other increase your risk
of heart failure. These are virtually guaranteed side effects
from these drugs when taken individually, but what has not even
been studied is the synergistic toxicity of taking
these dangerous drugs together.
So far, Merck has discussed the alleged efficacy of their
once-a-week DPP-4 inhibitor. However, clinicaltrials.gov
indicates that the SAFETY trial isn't until Phase III, which is
just now beginning. Still, with or without company-performed
(read biased) safety trials, there's plenty of reason
to suspect these drugs can, and probably will, spell severe
trouble for diabetics who take them. For example, Sitagliptin,
sold under the names Januvia11
and Janumet, has a number of admitted side effects, including:
- Low blood sugar
- Allergic reactions and anaphylaxis (rash, hives,
swelling of face, lips, tongue and/or throat)
- Acute pancreatitis
- Death
Anaphylaxis is in fact such a grave hazard with this drug
that it actually carries a black box warning for lactic
acidosis: "If acidosis is suspected, discontinue
Janumet and hospitalize the patient immediately"
According to diatetesselfmanagement.com12:
"... DPP-4 was discovered through its association
with the immune system, and some researchers thought that
inhibiting it might impair the immune system. So far, data
from clinical studies have not demonstrated a serious
immunosuppresive effect. They do indicate, though, that
sitagliptin increases the risk of upper respiratory
infections and nasopharyngitis (inflammation of the nose and
pharynx), found in 6.3% and 5.2% of study subjects,
respectively, who took sitagliptin versus 3.3% and 3.4% for
placebo.
The most worrying side effects are those reported
since the drug came onto the market.
These reactions seem to be allergic in nature and
include anaphylaxis, a bodywide reaction that results in low
blood pressure, and angioedema, a swelling of the tongue,
face, and throat. Both of these may be life-threatening. The
reactions have occurred anytime from immediately after
taking the first dose until three months after starting the
drug. There have also been reports of skin reactions,
including a very severe type of drug reaction called
Stevens–Johnson syndrome. Other diabetes drugs are not
typically associated with Stevens–Johnson syndrome."
The Science You Don't Hear About — DPP-4 Inhibitors Repeatedly
Linked to Cancer...
Another potential side effect of this class of drugs that you
won't see in any drug advert or hear from your doctor is its
potential link to cancer... Upon review of the medical
literature, a number of studies have already indicated a
connection of pancreatic, thyroid, colon, melanoma, and prostate
cancer with DPP-4 inhibitors. Such studies include:
- A 2006 study13
found that "the use of DPPIV inhibitors together with GLP-2
led to increased proliferation as well as elevated migratory
activity. Therefore, the use of DPPIV inhibitors could
increase the risk of promoting an already existing
intestinal tumor and may support the potential of colon
cancer cells to metastasize"
- One 2008 study14
found that DPP-4 inhibitors may proteolytically inactivate
local mediators involved in gliomagenesis (the formation and
development of brain tumors). Another study published that
same year15
linked the drug to prostate cancer
- In 201016,
researchers concluded that "although the data on the effects
of DPP-IV inhibitors in humans are scarce, the increased
risk of infections and the tendency towards a higher
incidence of some tumors fall in line with experimental
evidence suggesting the possibility of their adverse
immunological and oncological effects"
- According to a 2011 study in the journal
Gastroentorology17,18:
"data are consistent with case reports and animal studies
indicating an increased risk for pancreatitis with
glucagon-like peptide-1 based therapy. The findings also
raise caution about the potential long-term actions of these
drugs to promote pancreatic cancer, and DPP-4 inhibition to
increase risk for all cancers"
- Earlier this year, researchers warned19
DPP-4 "is implicated in regulation of malignant
transformation, promotion and further progression of cancer,
exerting tumor-suppressing or even completely opposite -
tumor-promoting activities.
This study indicates the need for exploring the cause and
the importance of the disturbances in the serum DPP-4
activity and in the CD26 expression on immunocompetent cells
in complex molecular mechanisms underlying the development
and progression of melanoma. Significant decline in
serum DPP-4 activity found in melanoma patients compared to
healthy controls might indicate its possible role in
development and progression of melanoma, but
further research needs to be done in order to fully
elucidate the cause and the importance of observed changes
in DPP-4 activity"
Logic Quiz: DPP-4 is a Tumor Suppressor, So What Happens When
You Continuously Inhibit DPP-4?
A 2008 blog post on DiabetesUpdate20
spells out the concerns I have about this class of diabetes
drugs:
"Two new studies grabbed my attention and should be
of great interest to anyone taking Januvia. These studies
looked at the impact of inhibiting DPP-4 on the growth of
two different kinds of cancers. This is important
because the way Januvia lowers blood sugar is by inhibiting
DPP-4. It does this because DPP-4 is a protease (an enzyme
that chops up protein chains) that, among other things,
destroys a hormone, GLP-1, that helps control blood sugar
levels. When you inhibit DPP-4, GLP-1 levels to rise and
blood sugars drop.
But none of the drug industry-sponsored testing for
the safety of Januvia looked at the other things that DPP-4
does. Fortunately, some academic researchers not-funded by
drug makers are doing this and what they are finding should
make any sane person stop taking Januvia. Because it turns
out that DPP-4 is also a tumor suppressor.
And when you inhibit it, cells that have become cancerous
get a 'get out of jail free' card."
Just think about the logic (or rather, the lack thereof) of
taking a drug that continuously inhibits one of your body's
natural cancer suppressing mechanisms! According to Januvia's
drug information, the drug inhibits the DPP-4 enzyme for 24
hours, and you take it daily, effectively permanently
blocking the activity of a tumor suppressor gene. Yet none of
the safety studies on Januvia addressed its impact on tumor
growth!
Is this wise? I don't see how it can be — especially
for a disease that doesn't require drug treatment to be
resolved. The blogger received the following emailed note21
from a researcher who worked on one of the studies listed above
(the author and study in question was not identified, and
probably for good reason):
"... Inhibiting DPPIV function in general (according
to ours and others research) may not be a great idea. I
believe that decrease or loss of DPPIV may be associated
with cancer initiation or progression. We have shown that
loss of DPPIV is indeed associated with melanoma, prostate
and lung cancers. Importantly our work has shown that
restoring DPPIV can suppress the tumor growth..."
In a 2010 article in the journal Diabetes Care22
entitled "GLP-1–Based Therapy for Diabetes: What You Do Not Know
Can Hurt You," the authors state:
"In conclusion, we believe it is premature to
conclude that the GLP-1 class of drugs has been established
as having a good safety profile and is appropriate for a
relatively early choice of therapy for type 2 diabetes.
There are grounds for concern that the GLP-1 class of
drugs [which includes DPP-4 inhibitors] may induce
asymptomatic pancreatitis and, over time in some
individuals, induce pancreatic cancer... [T]he implications
of the data are sufficiently serious that continuing to
promote this class of drugs without establishing clear
experimental evidence to permit the concern to be rejected
is irresponsible. Moreover, arguably patients prescribed
these drugs should be made aware of the potential risks of
pancreatic cancer."
"Researchers" Who Debunk Cancer Link are Paid Spokespersons for
Big Pharma
Not surprisingly, some researchers have spoken out against
studies linking DPP-4 inhibitors and GLP-1 agonists (such as
Byetta, which was approved in 2009) with various cancers,
calling such findings "flawed." Alas, it may be wise to look at
who these people are, and who pays them. In an IBJ.com article
published last year23,
Dr. Michael Nauck, head of the Diabeteszentrum Bad Lauterberg in
Harz, Germany said, with regards to studies linking GLP-1
agonist drugs Byetta and Victoza with increased risk of cancer:
"The bulk of findings tends to speak against such an
association... There is no general agreement."
According to the article:
"Nauck debated Peter Butler of the University of
California at Los Angeles at the European Association for
the Study of Diabetes meeting Friday on whether so-called
GLP-1 therapies increase cancer risk. Sales of the drugs may
be hurt should Butler's view prevail that there are signs of
increased cancer from the drugs. He and other UCLA
researchers said in a study this year that a review of a
database of side effects showed patients taking Byetta and a
Merck & Co. drug [Januvia] had a higher chance of
developing pancreatic or thyroid tumors. The treatments are
safe and there's no evidence of a higher cancer risk,
according to the manufacturers of the drugs."
Who is Michael Nauck
24? While his biography may not spell it out,
Professor Nauck has been a speaker and consultant25
for a long list of pharmaceutical companies, including Amylin
Pharmaceuticals (the maker of Byetta), Novo Nordisk (maker of
Victoza), Merck, AstraZeneca, Bristol Myers Squibb, Eli Lilly &
Co, and GlaxoSmithKline, just to rattle off a few. Note the
first two I listed are the very makers of the very drugs he's
arguing the safety of. So much for an independent opinion. He's
also received grants and financial research support from a
number of drug companies.
According to Peter Butler26,
co-author of the Gastroenterology study listed earlier, the
GLP-1 drug class "could have serious unintended and unpredicted
side effects." His research discovered that patients taking
Byetta and Januvia had a:
- Six-fold increased chance of pancreatitis, and
- Nearly three times greater rate of pancreatic cancer
In a September 2011 article in Bloomberg27,
Matteo Monami, a physician at the University of Florence and
Carreggi Teaching Hospital in Italy called Butler's study "an
erroneous analysis," stating that its results "are really not
reliable at all." Monami countered Butler's findings with a
meta-analysis28
of his own, which not only found no increase in cancer or
pancreatitis for DPP-4 inhibitors like Januvia, but also
"possible protection from cardiovascular events."
What the media failed to report was that Monami is a paid
spokesperson for Merck (the maker of Januvia — the drug
at the center of the controversy), Astra Zeneca, Bristol Myers
Squibb, Eli. Lilly, Novo Nordisk, and Takeda. Knowing he's a
paid Big Pharma spokesperson, surely no one can be surprised
that Monami's analysis and "professional opinion" clears his
employers' drugs of any potential cancer links...
Billions of Dollars at Stake...
When Merck and the FDA finally agree that DPP-4 inhibitors
are linked to cancer, it will kill several of the most recent
drug developments for diabetes. Untold hundreds of millions, if
not billions of dollars have already been invested in getting
these new drugs to market. And the profits from these drugs are
expected to be in the tens of billions at minimum..
According to Merck, Januvia is now the number one
best-selling drug in the oral diabetes market. Should such a
blockbuster drug be proven to be connected to cancer, it would
be a HUGE loss not only to Merck, but several other major
pharmaceutical companies that have developed similar drugs.
One of the most horrific parts of this is the fact that
cancer can take decades to form — unless the drug
dramatically speeds up the process by inhibiting your
body's ability to suppress tumor growth. Merck's lethal drug
Vioxx was only withdrawn from the market after its lethality
became too obvious to ignore. Ditto for the dangerous diabetes
drug Avandia. Those drugs caused heart attacks and stroke.
Cancer, on the other hand is not something that will tend to
make people keel over after a relatively short period of time.
They could make MASSIVE amounts of money from these clearly
dangerous drugs while cancer slowly and quietly grows in
patients taking them, while biased shills maintain that the
science is still "unclear." I for one would urge you to
reconsider taking any kind of DPP-4 inhibitor. Why risk cancer
for an ailment you can effectively address without ANY drug at
all?
Type 2 Diabetes is Nearly 100 Percent Preventable... and
Reversible Without Drugs
There is simply no doubt in my mind that these drugs will be
removed from the market, but not after many years, potentially
decades, and likely after they have killed tens of thousands of
people. But you don't have to needlessly suffer and wait till
they are formally removed. You can stop taking them now.
Reversing type 2 diabetes is one of the simplest and most
straight-forward treatments in all of medicine.
It's important to understand that many of the conventional
recommendations for treating diabetes are not only flawed but
dead wrong, and I discussed the reasons why in
this previous article. To reverse the disease, you need to
recover your body's insulin and leptin sensitivities –
the ones that are so badly upset by eating a poor diet. The ONLY
way to accomplish this is
through proper diet and exercise. There is NO drug that can
correct leptin signaling and insulin resistance.
It will be absolutely crucial to eliminate ALL sugars and
virtually all grains from your diet. You want to strive for an
ultra-low carbohydrate diet seeking to restrict your carbs to
high fiber vegetables only. You can replace the missing carbs
with high quality fats like coconut oil, which are rapidly
broken down and consumed as fuel so you won't feel as tired or
fatigued when you make the transition to fat burning mode. Using
intermittent fasting and restricting all your calories to a
6-8-hour window will also radically help your ability to
transition to fat burning mode and improve your insulin and
leptin signaling.
Adhering to the following guidelines can help you do at least
three things that are essential for successfully treating, and
reversing, diabetes: recover your insulin/leptin sensitivity,
help normalize your weight, and
normalize your blood pressure:
- Severely limit or eliminate sugar and grains in your
diet, especially fructose, which is far more detrimental
than any other type of sugar. Following
my Nutrition Plan will help you do this without too much
fuss. Likely long before you work your way up to the
Advanced Section, your type 2 diabetes will be under control
without any drugs.
-
Exercise regularly. Exercise is an absolutely essential
factor, and without it, you're unlikely to get this
devastating disease under control. It is one of the fastest
and most powerful ways to lower your insulin and leptin
resistance. I recommend
reviewing my exercise program for tips and guidelines.
It is also critical to work your way up to include some
Peak Fitness exercises.
- Avoid trans fats.
- Get plenty of
omega-3 fats from a high quality, animal-based source,
such as krill oil.
-
Optimize your vitamin D levels. Recent studies have
revealed that getting enough vitamin D can have a powerful
effect on normalizing your blood pressure.
- Optimize your gut flora. Your gut is a living ecosystem,
full of both good bacteria and bad. Multiple studies have
shown that
obese people have different intestinal bacteria than lean
people. The more good bacteria you have, the stronger
your immune system will be and the better your body will
function overall.
Fortunately, optimizing your gut flora is relatively
easy. You can reseed your body with good bacteria by eating
fermented foods (like natto, kefir, raw organic cheese,
miso, and
fermented vegetables) or by taking a high-quality
probiotic supplement.
- Address any underlying emotional issues and/or stress.
Non-invasive tools like the
Emotional Freedom Technique (EFT) can be extremely
helpful and effective.
- Get enough
high-quality sleep every night.
- Monitor your fasting insulin level. This is every bit as
important as your fasting blood sugar. You'll want your
fasting insulin level to be between 2 and 4. The higher your
level, the worse your insulin sensitivity is.
© Copyright 1997-2012 Dr. Joseph Mercola. All Rights Reserved.