Dec 1, 2011
Drug maker GlaxoSmithKline has preliminarily agreed to a $3 billion settlement over the sales and marketing practices of several of its drugs, including the diabetes drug Avandia.
This represents the largest federal drug-company settlement to date, surpassing the $2.3 billion paid by Pfizer in 2009 for illegally promoting off-label uses of four of its drugs.
The sum, though extraordinarily large by most people’s standards, represents only a slap on the wrist to the drug giant, which assured investors the payments would be funded by “existing cash resources.”
To put things into perspective, GlaxoSmithKline has a market value of more than $110 billion, according to the New York Times.
This massive financial clout essentially allows them to engage in criminal behavior that they can later buy their way out of – not unlike the way you might pay for a speeding ticket.
As Sidney M. Wolfe, director of Public Citizen’s health research group, told the Washington Post:
“The size of the penalties, although large, are not as large as the money [the drug companies] make and so they keep doing it over again …
The only way this is going to stop, or get reversed, is to greatly increase the size of the penalties or to start sending some of the executives to jail, if appropriate.”
The Culmination of a Seven-Year Investigation
GlaxoSmithKline’s $3-billion settlement is intended to bring a nearly decade-long legal saga to a close.
It started in 2004, when federal prosecutors began investigating the drug maker for marketing a handful of its drugs for unapproved uses, as well as the suspect techniques their reps used to influence doctors. The settlement also includes a U.S. Justice Department probe into potential Medicaid reimbursement fraud, as well as an investigation into the company’s development and marketing of the Avandia diabetes drug.
After hitting the market in 1999, a 2007 study in the New England Journal of Medicine linked Avandia to a 43 percent increased risk of heart attack, and a 64 percent higher risk of cardiovascular death, compared to patients treated with other methods!
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 GlaxoSmithKline.
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.
Avandia works by making diabetic patients more sensitive to their own insulin, resulting in lower blood sugar levels. The problem is that despite clinically measurable improvement in blood sugar control following the use of this drug, hard outcomes associated with diabetes such as endothelial dysfunction and heart attack risk may actually worsen.
Because Avandia, like all pharmaceutical drugs, are synthetic chemicals and do not obey the same laws that natural substances do in your body (Remember: our body is composed of the natural things we have eaten and not chemicals). A simple change in the geometry of a molecule’s “handedness” – i.e. whether it turns a beam of polarized light to the “left hand” or “right hand” — can make the difference between endocrine correction and disruption; therapeutic activity and toxicity.
Although Avandia may correct a blood sugar imbalance by locking into the insulin receptors in a superficially beneficial way, it may also block out and/or disrupt many other processes in the body that can result in great harm.
Nature actually does the job much better anyway. In a 2009 study published in the Journal of Phytomedicine the herb and traditional food known as Bitter Melon was found to be superior to Avandia in the management of diabetes and its related complications.
It is also important to remember that type 2 diabetes is not caused by a lack of any drug, and that nutrition and lifestyle changes, as well as regular exercise holds the key to improving the health and well being of diabetics in a sustainable manner.
Despite the availability of alternative approaches, millions of people have been told to take Avandia and have been exposed to these unacceptably high-risk side effects. The statistics show that more than 80,000 diabetics have suffered from strokes, heart failure or other complications including lethal heart attacks from this dangerous drug.
It took nearly 10 years of the drug being on the market for the FDA to finally take action and restrict access to this dangerous drug, whereas the European Medicines Agency banned it altogether.