Saturday, 5 February 2011

Type 2 Diabetes - Avandia and the Families Affected

One can only begin to imagine the painful mix of outrage and grief that the Larosa family must have experienced after the wrongful death of Milagros Larosa.  After being hospitalized on three different occasions over one year during 2004 – 2005 Ms. Larosa then was stricken by a fatal stroke. Ms. Larosa was a type 2 diabetic  taking Avandia to provide glycemic control.  Prior to taking Avandia, Ms. Larosa had never experienced heart disease .    It is clear that Avandia was the cause of both her heart problems and the stroke.  Due to hundreds of incidents like Ms. Larosa's, Avandia lawyers have filed tens of thousands of lawsuits against the manufacturer of Avandia --GlaxoSmithKline(GSK).  These lawsuits provide remuneration for the victim's families, but do little to quiet their rightful indignation.

Type 2 diabetes, also referred to as adult onset diabetes, is a metabolic disorder characterized by insulin resistance and dangerously mercurial blood sugar levels.  As implied by its name, this is not an ailment you are born with, but rather a problem that develops with age.   It has been most common among middle-aged and elderly patients, however, with frighteningly increasing frequency, it is occuring among adolescents.  One reason for its increase among younger people may be correlated to the increase in childhood obesity.  Obesity, as well as hypertension, poor diet, lack of exercise, and excessive alcohol consumption are all factors that can increase the risk for developing adult onset diabetes.  If left untreated, type 2 diabetes can lead to blindness, renal failure, slow healing wounds, and most seriously, coronary artery disease.

A change in lifestyle is often the least expensive and most efficacious therapy that a type 2 diabetic can undertake. Through regular exercise and an improvement in their diet, patients frequently can achieve glycemic control.  However, numerousmedications have also demonstrated effective results.   Avandia, which is GSK's market name for the drug rosiglitazone, effectively helps patients manage blood levels of glucose, fatty acids and insulin by acting as an insulin sensitizer.  It also has the added benefit of acting as an anti-inflammatory.  However, a study in 2007 showed that Avandia increases a patient's risk for heart attack by 43%, and by even more for death related to heart disease. In 2008 the Senate Finance Committee accused GSK of knowing and concealing these risks of heart disease before they became public knowledge with the release of the 2007 study .  Avandia lawyers assert that GSK negligently failed to disclose to patients, doctors, and regulatory authorities the extensive information they had which linked Avandia to heart disease. GSK has now come to settlement agreements on over 17,000 cases, paying in excess of $520 million.

It is common knowledge that medications often cause unwanted -- even harmful -- side effects. In fact, this seems to be an inescapable reality of medicine.  However, for GSK to release and promote Avandia, a drug they knew to increase the risk for heart problems, to type 2 diabetes patients – a group who is also inherently at risk for coronary problems -- is absolutely inexcusable.  While Avandia lawyers have applied monetary consequences to GSK, these payments can only provide limited solace to the families affected.  As cases like Avandia become more regularcommon, one must ask, where will this lead the pharmaceutical industry and regulatory bodies in the future?  Clearly there is a moral obligation to patients' safety, but the failure of Avandia and the successes of Avandia lawyers also does not bode well for GSK's bottom line.  We can only hope that pharmaceutical technology and the corporations that drive it will hold themselves to higher standards, realizing that this is not just the moral choice, but also the wisest choice for business.


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