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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 thedangerous 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 Avandia 5, 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.

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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 inhibitor s6 (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 bloodglucose 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.

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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, tongueand/or throat)

   Acute pancreatitis

  Death

 Anaphylaxis is in fact such a grave hazard with this drug that it actually carries a blackbox warning for lactic acidosis: " If acidosis is susp ected, discont inue Janum et and 

hosp i talize the pat ient imm ediately"  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 RepeatedlyLinked 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

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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 useof DPPIV inhibitors could increase the risk of promoting an already existingintestinal tumor and may support the potential of colon cancer cells tometastasize"

  One 2008 study14 found that DPP-4 inhibitors may proteolytically inactivate localmediators involved in gliomagenesis (the formation and development of braintumors). Another study published that same year 15 linked the drug to prostatecancer 

  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 thetendency towards a higher incidence of some tumors fall in line withexperimental evidence suggesting the possibility of their adverse immunologicaland oncological effects"

   According to a 2011 study in the journal Gastroentorolog y 17,18: "data areconsistent with case reports and animal studies indicating an increased risk for pancreatitis with glucagon-like peptide-1 based therapy. The findings also raisecaution about the potential long-term actions of these drugs to promotepancreatic 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, exertingtumor-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 YouContinuously Inhibit DPP-4?

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 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 tumo r sup pressor . 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 note 21 from aresearcher 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.

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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 year 23, 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 Nauck24

? While his biography may not spell it out, Professor Nauck hasbeen 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.

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 According to Peter Butler 26, 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 Bloomberg 27, 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 (themaker 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.

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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 ReversibleWithout 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 myNutrition Plan will help you do this without too much fuss. Likely long before youwork your way up to the Advanced Section, your type 2 diabetes will be under control without any drugs.

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  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 thefastest and most powerful ways to lower your insulin and leptin resistance. Irecommend reviewing my exercise program for tips and guidelines. It is alsocritical 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 krilloil.

  Optimize your vitamin D levels. Recent studies have revealed that gettingenough vitamin D can have a powerful effect on normalizing your bloodpressure.

  Optimize your gut flora. Your gut is a living ecosystem, full of both good bacteriaand 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 likethe Emotional Freedom Technique (EFT) can be extremely helpful andeffective.

  Get enough high-quality sleep every night.

  Monitor your fasting insulin level. This is every bit as important as your fastingblood sugar. You'll want your fasting insulin level to be between 2 and 4. Thehigher your level, the worse your insulin sensitivity is.

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