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The Avandia Debate: Drug Company Greed or a Broken System?

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An intense debate has broken out over the type 2 diabetes drug Avandia. While research has shown that increased cardiovascular risk is a side effect of Avandia, advisers to the Food and Drug Administration recommend keeping the drug on the market. Is this the result of a broken system, drug company greed, or both?

Some prominent researchers, including those at the FDA, have demonstrated that Avandia, which aims to lower blood sugar, is associated with an increased risk of heart attack, stroke, and heart-disease-related death. While the manufacturer, GlaxoSmithKline, points to trials they conducted that have found no increase in such risks, researchers for at least one study sponsored by GlaxoSmithKline failed to categorize heart attacks and hospitalizations as "heart-related." They also failed to investigate certain deaths that may have been linked to Avandia.

Back in 2007, a black box warning -- the sternest level of drug label warning -- was added to Avandia and Actos, another drug with a similar mechanism of action. Data suggesting that Avandia may not be safe dates back to 1999. Since the reason to lower blood sugar is to ultimately reduce cardiovascular risk, the fact that these drugs may actually increase said risk is especially problematic. Along with many other physicians, I stopped prescribing Avandia and Actos in 1999. Yet despite disturbing data, these drugs continue to be blockbusters for their companies.

How could this be? While many blame the greedy drug companies and lack of oversight by the FDA, there are many at fault: the drug companies, the FDA, physicians and medical societies. The FDA should not be considered the primary safety net for patients.

So what happened? First, many physicians don't have the time to routinely read the massive amount of medical literature published each week in journals -- and they certainly don't have the time to critically analyze studies. Most doctors therefore rely on medical societies and drug company sales representatives to keep them informed. The problem of relying on pharmaceutical salespeople is obvious. Less obvious is the fact that over 90 percent of the funding for medical societies comes directly from drug companies.

While all drugs come with risks, a physician should accurately assess the risk-to-benefit ratio of a particular therapy for a particular patient. A doctor must not assume that a drug representative or a medical society has the patient's best interest in mind. The fact is, many once-popular drugs have been taken off the market, including Vioxx, Pondimin, Seldane, Propulsid, Rezulin and many others that have had black box warnings added after approval.

Below is a list of documented side effects or risks of commonly prescribed medications. These issues are rarely discussed with patients. The potentially serious side effects of the below medications may well to come to light as more data is released.

Selective serotonin reuptake inhibitors

The most common class of antidepressants, SSRIs -- including Prozac, Zoloft, Lexapro and Celexa -- significantly increase the risk of diabetes and double the rate of bone loss.

Proton pump inhibitors
Proton pump inhibitors, such as Nexium, Protonics and Prevacid, treat digestive disorders. They're also associated with a dramatic increase in bacterial overgrowth in the gut, causing irritable bowel syndrome and a significant risk of diarrhea. They are also shown to reduce the absorption of thyroid hormone replacement and to increase the risk of osteoporosis and bone fractures.

Statins

Certain populations -- including people suffering from fibromyalgia, chronic fatigue syndrome and hypothyroid -- are shown to be at significantly higher risk for side effects when they use cholesterol-lowering statin drugs like Lipitor, Crestor and Zocor. These patients have a heightened risk of muscle pain, memory problems and immune problems. They also face a potential increased risk of diabetes. Emerging studies suggest that statins may also increase the risk of breast cancer.

Bisphosphonates for osteoporosis
Bisphosphonates such as Fosamax, Acetenol, Reclast and Boniva are widely used to treat osteoporosis and have been shown to reduce the incidence of new fractures in patients with established osteoporosis. In women with osteopenia (low bone density), bisphosphonates have been shown to prevent bone loss, and physicians prescribe them with the hope of preventing future fractures. There is, however, growing concern regarding the long-term consequences of these drugs. A recent study of over 13,000 patients published in the Journal of the American Dental Association found that 1 in 25 patients taking Fosamax suffered from osteonecrosis of the jaw: In layman's terms, that means that the jaw bone disintegrates. Research has also shown an increase in brittleness-related fractures of large bones like the femur. Moreover, patients may well face a heightened risk of heart arrhythmias and esophageal cancer.

The Avandia debate encapsulates a major problem with our current medical system, which focuses primarily on cost-effectiveness and emphasizes a mass-medicine approach with one-size-fits all protocols. Such an approach does not allow individualized care and significantly raises the risk of patients suffering from medication-related side effects. Treatment decisions are increasingly left to third party payers and bureaucrats, while they should be made by an informed, empowered patient and his or her knowledgeable doctor. The result of this broken system, as the Avandia controversy shows, is dissatisfied patients, frustrated doctors, sub-par care, and poor treatment results.
*Important -- Content Solely Informational:
Content concerning health or medical matters is for informational purposes only and is not intended to be used as a substitute for professional medical advice, diagnosis or treatment. Please consult your doctor or a qualified healthcare provider with any questions you may have about a medical condition, before embarking on a weight loss program or beginning a new or changing an existing treatment plan.

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