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FDA Loosens Restrictions on Diabetes Drug Avandia

December 18, 2013 | 35,559 views
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By Dr. Mercola

Diabetes drug Avandia hit the market in 1999 and quickly became a blockbuster drug. By 2006, its annual revenue was more than $3 billion, but this changed following an alarming study published in the New England Journal of Medicine (NEJM) in 2007.1

The study linked Avandia to a 43 percent increased risk of heart attack and a 64 percent higher risk of cardiovascular death than patients treated with other methods.

In response to this and subsequent related evidence, Europe banned Avandia, taking it completely off the market.

In 2010, the US Food and Drug Administration (FDA) took a lesser action by restricting access to the drug, which meant that only those unable to control their diabetes using some other form of medication would be given new prescriptions.

It was a small step in the right direction but even then one that many experts believed did not go far enough to protect patients’ health. And now in the latest turn of events, the FDA has announced that they will be lifting the restrictions they put in place…

FDA Removes Certain Prescribing Restrictions for Avandia

In June 2013, an FDA advisory panel voted in favor of loosening the Avandia restrictions put in place in 2010, and in December, the FDA announced it would be following suit.

The reversal is based on the RECORD study, which was conducted by the drug’s maker, GlaxoSmithKline, at FDA’s request. According to an FDA statement, the study’s results, made public in 2009, "showed no elevated risk of heart attack or death in patients being treated with Avandia when compared to standard-of-care diabetes drugs.”

This lead Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, to state:

"Our actions… reflect the most current scientific knowledge about the risks and benefits of this drug… Given these new results, our level of concern is considerably reduced; thus, we are requiring the removal of certain prescribing restrictions."

Yet, the RECORD study has been heavily criticized. According to CNN:2

Although GlaxoSmithKline said the safety data were reassuring, the study was heavily criticized by Dr. Thomas Marciniak, an FDA scientist who reviewed the data and said the company ignored several cases of patients who suffered severe adverse effects.”

Concerns were also raised in 2010, when the New York Times reported that GlaxoSmithKline not only hid negative study data but also manipulated study data to fit their agenda:3

“An F.D.A. reviewer who closely examined a landmark Avandia clinical trial called “Record,” found at least a dozen instances in which patients taking Avandia suffered serious heart problems that were not counted in the trial’s tally of adverse events, mistakes that further obscured Avandia’s heart risks.

The company’s conduct of the Record trial has received sharp criticism from medical leaders for other reasons as well. To compare Avandia and Actos in 1999, researchers at SmithKline measured Actos’s effects in patients in the same way that they had conducted earlier trials of Avandia so that the results for the two drugs could be compared.

When the results of the study suggested that Avandia was more dangerous than Actos, the company decided against further comparisons.”

In response to the criticisms, the FDA recommended that GSK choose an independent group to review RECORD’s results, which also came back in favor of the drug, prompting the June 2013 FDA panel hearing.

Is the FDA Simply Trying to Save Face?

Today, only about 3,000 Americans take Avandia, and they are closely monitored for side effects by both the FDA and GlaxoSmithKline.4 With the loosened restrictions, however, the drug will once again be available through regular pharmacies to all type 2 diabetes patients, without required monitoring or tracking.

The FDA also noted that GlaxoSmithKline would no longer be required to conduct a clinical trial to compare Avandia to its main rival, Actos, or other diabetes drugs, known as the TIDE trial.5

Interestingly, the Associated Press (AP) called the announcement a “vindication of sorts for FDA leadership, including Woodcock,” who they reported agreed to the original Avandia restrictions only after “years of pressure from outside researchers, safety advocates and several members of Congress.”6

Dr. Steven Nissen, who conducted the study showing increased heart risks surrounding Avandia, seemed to agree, telling the AP:7

"This is about appearances, not changing medical practice… A single reanalysis of a trial does not exonerate a drug where all the other data point to increased cardiovascular risks.”

Please remember that this is the company that paid a total of $3 billion in fines -- $1 billion to settle criminal charges, and $2 billion to cover civil liabilities – to settle this, and other, violations less than one year ago.

It is beyond rational comprehension how a company like this could possibly be trusted with a study that they did and is obviously loaded with massive conflict of interest… especially in light of the fact that the Europeans already determined that this drug was FAR too dangerous and they removed it from the market.

The FDA’s move, unfortunately, is none too surprising, however. As early as 2005, one unnamed senior FDA scientist, who was once Avandia’s primary reviewer, began voicing concerns that Avandia should have a “black box” warning due to its risk of congestive heart failure. In response, the FDA swiftly removed the scientist from participating in further reviews of the drug…8

The only silver lining to the FDA’s announcement may be that experts believe a return of Avandia to blockbuster status is unlikely, given its poor reputation and the abundance of newer treatments now on the market.

Diet and Exercise May Reverse Diabetes Without Drugs

One in four Americans has some form of diabetes or pre-diabetes, and the go-to treatment is typically drugs that target your blood sugar levels. Yet, the cure for type 2 diabetes has nothing to do with giving insulin or taking drugs to control your blood sugar.

In one four-year-long study, overweight and obese diabetics placed on a calorie-restrictive diet along with nearly three hours of exercise per week fared much better than controls. After one year, 11.5 percent of the program participants no longer needed medication to keep their blood sugar levels below the diabetes threshold.9

Another recent randomized, double-blinded, placebo-controlled clinical trial, published in the American Diabetes Association’s own journal Diabetes, found that a turmeric extract (curcumin) was 100% effective in preventing the development of type 2 diabetes in prediabetics over the course of a 9-month intervention.10

I also believe following the dietary recommendations laid out in my free Nutrition Plan can provide far better results than those achieved in this study. The truth of the matter is that type 2 diabetes is a fully preventable condition that arises from faulty leptin signaling and insulin resistance, both of which are directly diet and exercise related. It is NOT a disease of blood sugar.

Once you understand that, the remedy becomes clear: to reverse the disease, you need to recover your body's insulin and leptin sensitivities. The best way to accomplish this is through proper diet and exercise, as detailed in my free Nutrition Plan. There is no drug that can correct leptin signaling and insulin resistance...

Prevent and Even Reverse Diabetes with These Lifestyle Changes

Avandia is soon going to become much more widely available, but before you consider it as a viable treatment (regardless of where you stand on the debate over its heart risks), try revamping your lifestyle first. Adhering to the following guidelines can help you do at least three things that are essential for successfully preventing and treating diabetes: recover your insulin/leptin sensitivity, normalize your weight, and normalize your blood pressure:

  • Severely limit or eliminate sugar and grains in your diet, especially fructose. Following my Nutrition Plan will help you do this without too much fuss.
  • Exercise regularly, including high-intensity interval training (HIIT). 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.
  • 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 and that low vitamin D levels may increase your risk of heart disease.
  • Optimize your gut flora. Your gut is a living microbial 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 (such as fermented vegetables, natto, raw organic cheese, or raw milk kefir) 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 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.
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