September 23, 2010 article in the New England Journal of Medicine announced that, finally, the FDA has stepped forward and decided on regulatory action for Avandia, a diabetes drug that last year claimed 1,354 lives as a result of cardiac-associated problems.
The FDA is restricting access to Avandia by requiring GSK to submit a Risk Evaluation and Mitigation Strategy, or REMS.
Under the ruling, the drug will be available to patients not already taking it only if they are unable to achieve glycemic control using other medications and, in consultation with their health care professional, decide not to take a different drug for medical reasons.
Current users of Avandia will be able to continue using the medication if they appear to be benefiting from it and they acknowledge that they understand these risks. Doctors will have to attest to and document their patients’ eligibility; patients will have to review statements describing the cardiovascular safety concerns.
But did the FDA go far enough – could it be too little, too late?
Unlike the US FDA, British regulators have ruled that GlaxoSmithKline’s diabetes drug Avandia could lead to heart attacks or strokes, and benefits no longer outweigh the risks.
And so last week, they told 90,000 British diabetes patients to stop taking it.
Evidence linking Avandia to an increased risk of a heart attack or stroke has been building since 2007, and GSK has agreed to pay $460 million in damages to settle about 10,000 lawsuits in America linking its use to patients suffering serious medical setbacks. But the US FDA has chosen only to monitor the drug, rather than ask for a recall.
Sources:
New England Journal of Medicine September 23, 2010
Philly.com June 17, 2010
The Guardian 23, 2010
Philly.com September 23, 2010
Dr. Mercola's Comments:
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Like Vioxx, the case of Avandia has turned into yet another classic example of what is fundamentally wrong with the conventional medical paradigm.
Diabetes has increased more than 700 percent in the last 50 years. Today, more than one in four Americans are either pre-diabetic or have full-blown diabetes.
In response, conventional medicine offers up drugs that in no way, shape or form treat the cause of the problem, and worse yet, can prematurely kill many of those who take them.
The drug in question here, rosiglitazone, is sold under the names of Avandia, Avandamet and Avaglim. Avandia alone is used by 2 million people worldwide.
But other diabetic drugs are not necessarily any safer. Two years ago I wrote about Byetta, an “add-on” drug for diabetes (meaning it’s usually prescribed in combination with other drugs) that can cause acute and in some cases lethal pancreatitis.
The saddest part about this debacle is that type 2 diabetes is not only a completely avoidable disease, but also one that in nearly all cases can be successfully reversed without ever touching a drug.
The only thing rosiglitazone drugs like Avandia do is to help lower blood glucose, which has virtually no influence on the long-term damage due to type 2 diabetes. Most of the damage is caused by elevated insulin levels, which can be remedied with an optimal diet and exercise program alone, if you’re compliant.
Another aspect of this story that makes Avandia such a poster child for this lethal paradigm is the fact that GlaxoSmithKline, the manufacturer of Avandia, hid damaging information about the drug for over ten years, as it would adversely affect their sales!
Again and again we are confronted with indisputable evidence that the drug paradigm is about money, not health.
Between 1999 and 2007, Avandia is estimated to have caused 83,000 unnecessary heart attacks. This is a steep price, to say the least, for a disease that does not require drugs to begin with.
This is 20,000 more deaths than Merck caused when they sold Vioxx.
European Medicines Agency Bans Avandia
Avandia hit the market in 1999 and quickly became a blockbuster drug. By 2006 its annual revenue was $3.2 billion. By 2009, sales had dropped to $1.2 billion following a damning study published in the New England Journal of Medicine (NEJM) in 2007, which 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.
Unfortunately, a committee of independent experts recommended that Avandia remain on the US market, despite its risks, and an FDA oversight board voted 8 to 7 to accept the advice.
Since that 2007 NEJM study, data from various trials, studies and meta-analyses have consistently confirmed the dangers of this drug, and based on the evidence amassed over the past three years, the European Medicines Agency is now recommending the withdrawal of rosiglitazone-containing diabetic drugs due to the increased risk of ischaemic heart disease.
Their recent press release states that,
“… the Committee could not identify additional measures that would reduce the cardiovascular risk. The Committee therefore concluded that the benefits of rosiglitazone no longer outweigh its risks and recommended the suspension of the marketing authorization of the medicines.
Europe will cease all prescriptions of these drugs within the next few months.
American patients, however, will not receive the same protection from the US FDA.
Submitted By Dr. Mercola | October 11 2010 | 4,755 views
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