Diabetes Care: Avandia is a Symptom of the Problem with US Healthcare

My head was spinning from the webbed controversy over the type 2 diabetes drug, Avandia, which has been reported to have caused 304 deaths in the third quarter of 2009.

...once one of the biggest-selling drugs in the world. Driven in part by a multimillion-dollar advertising campaign, sales were $3.2 billion in 2006. But a 2007 study by a Cleveland Clinic cardiologist suggesting that the drug harmed the heart prompted the F.D.A. to issue a warning, and sales plunged. A committee of independent experts found in 2007 that Avandia might increase the risk of heart attack but recommended that it remain on the market, and an F.D.A. oversight board voted 8 to 7 to accept that advice. New York Times

Who is to blame here? I know a little something about the pharmaceutical industry--how drugs get to market, and how doctors and patients are informed. I have worked in a professional capacity with many global pharmaceutical companies and in many therapeutic areas, including diabetes. The benefits of the pharmaceutical industry’s advances in medical science and their development of treatments for incurable diseases far outweighs the risks associated with poor outcomes. However, I am not here to defend the industry. Glaxo Smithkline should pull Avandia off the market. But there is something even more important to recognize...

Avandia is a symptom of what’s wrong with healthcare and drug regulation in the United States. It is also a reflection of how poorly our physicians are educated. There are two major issues that Congress should be evaluating:

1. The expertise and ethics involved in FDA’s approval process for new drugs (NDAs). How did Avandia receive approval from the FDA – even with evidence of documented risks to diabetes patients?
2. How best practice care and guidelines are diffused and disseminated to those physicians (mostly primary care physicians) who treat patients with diabetes?

Reporting of the Avandia Scandal
I was shocked that none of the news programs or any of the press thought it important to address the complexities of type 2 diabetes as the Avandia scandal emerged. How can the dangers of a drug be discussed without addressing the disease? I’m not sure if this was a reluctance to get involved in the pathology behind the disease (too boring, too dry and too hard to explain) or if there is a general assumption that EVERONE knows enough about type 2 diabetes already. It is a gross assumption.

Type 2 diabetes (it accounts for 90-95% of all diabetes patients), Coronary Heart Disease
and Metabolic Syndrome (Insulin Resistance and Sydrome X) are terms that are tossed around interchangeably, but are rarely defined. In fact, Metabolic Syndrome has become somewhat clichéd – and often (inexcusably) overused as a euphemism for the overweight and under-educated. To make it simple Type 2 diabetes can be defined by two defects – the inability to secret insulin, and the body’s resistance to the action of insulin (breaking down sugar in the blood). These two defects are associated with dyslipidemia, obesity and hypertension (markers of Metabolic Syndrome) --which in turn are all risk factors for Coronary Heart Disease. You can have Metabolic Syndrome without having diabetes and you can have Coronary Heart/Vascular Disease without diabetes but every person with type 2 diabetes should also be treated for Heart Disease (CHD).

Furthermore, CHD is the leading cause of death (800,000 per year); diabetes accounts for 160,000-180,000 deaths per year and the leading cause of death for diabetes is – you guessed it – Coronary Heart disease. (How many of those 800,000 people who are reported to have died from CHD are actually people with type 2 diabetes, but undiagnosed?)

The first question is how did the FDA continue to approve a drug for market in 2007 if there was evidence that it could cause heart attacks for a patient population already at risk for CHD? What was the FDA thinking? How was that risk serving the interest of United States public healthcare? It wasn’t.

After FDA Approval
It is well documented that primary care physicians are overwhelmed by the high number of type 2 diabetes patients that walk through their doors, and how to care for them. When a new drug like Avandia is presented to the market – how does a primary care physician learn about its benefits and its risks? There are many ways a doctor can learn about a new drug:

1. Pharmaceutical representative calling on a doctor’s office and presenting the new drug
2. Continuing Medical Education (CMEs). The AACME is an organization which serves as the body accrediting institutions and organizations offering continuing medical education. They approve the Continuing Medical Education programs that are developed for physicians by these institutions and usually sponsored (funded) by the pharmaceutical industry.
3. Pharmaceutical Advisory Board members who are practicing doctors (often called Key Opinion Leaders) affiliated with the development of the drug, will participate in AACME approved symposia or lectures on a new drug/ its benefits. Often these KOLs will disseminate information about the efficacy of a drug so well that a phone call may be all it takes for one less informed physician to feel comfortable in prescribing a drug he knows little about.

Because Type 2 diabetes is such a complex disease with so many variables (as described before) and because primary care physicians (not endocrinologists or diabetologists) are caring for these patients, professional competencies are tested.

The management of people diagnosed with diabetes increasingly challenges health care personnel in the United States. The number of people with diabetes increases by ~ 1 million yearly,1 and diabetes was the primary diagnosis in 23.8 million visits to office-based physicians in 2006, most commonly to general practitioners, family physicians, and internists.2 Managing diabetes requires practitioners to be competent in complexities of disease management as well as in patient communication, counseling, and education—understanding how multiple psychosocial factors affect patient care and outcomes. Primary care practitioners (PCPs) are therefore required to master both physiological and psychosocial approaches to treatment and management. Yet many are challenged in doing so. Spectrum Diabetes Journal

Isn’t it time for Congress to assess how de-regulated private healthcare (including education of licensed physicians) isn’t serving public health? Avandia has really put this problem into the spotlight – if only Congress (and the media!) would address the core issues. The FDA acts as a lame watchdog, and without a regulatory roadmap – or a sound infrastructure to translate new medical therapies into clinical applications in a systematic way, medical advances and new therapies cannot result into tangible public benefits.. There has got to be a better way. President Obama, are you listening?