Yesterday the Food and Drug Administration (FDA) put some restrictions on the heart attack causing diabetes drug Avandia. This is an absurd decision showing how much Big Pharma owns our government. Europe had the nerve to outright ban this killer.
It is worth reading the entire New York Times article about the FDA’s decision to allow some continued Avandia use, but here are the first few paragraphs if you are in a hurry:
WASHINGTON — In a highly unusual coordinated announcement, drug regulators in Europe and the United States said Thursday that Avandia, the controversial diabetes medicine, would no longer be widely available.
The drug’s sales will be suspended entirely in Europe, while patients in the United States will be allowed access to the medicine only if they and their doctors attest that they have tried every other diabetes medicine and that patients have been made aware of the drug’s substantial risks to the heart. Patients now taking Avandia may continue to do so.
The Food and Drug Administration’s decision shows that the Obama administration is taking a harder line on drug safety issues, even in the face of scientific uncertainty. Along with its announcement, the agency for the first time immediately posted on its Web site internal memorandums from top staff members that in some cases offered entirely contradictory advice. Dr. Margaret Hamburg, the agency’s commissioner, said that passions within the agency had run high on the Avandia decision.
“As F.D.A. commissioner, my job would be infinitely easier if we had consensus and full scientific clarity,” she said.
Dr. Steven Nissen, a Cleveland Clinic cardiologist whose studies highlighted Avandia’s heart attack risks, said that the decision brought an end to “one of the worst drug safety tragedies in our lifetime,” adding that it was “essential to fully investigate what went wrong with the regulatory process to prevent this type of tragedy from endangering patients in the future.”
One study estimated that from 1999 to 2009, more than 47,000 people taking Avandia needlessly suffered a heart attack, stroke or heart failure, or died.
The decision on Avandia signals a new era in the treatment of diabetes, a disease that is reaching epidemic proportions in much of the industrialized world. Because of Avandia, the F.D.A. announced in 2008 that it would no longer approve medicines simply because they help diabetics control blood sugar levels — the standard for more than 80 years. Instead, the F.D.A. now insists that drugmakers conduct trials lasting at least two years to show that their medicines do not hurt the heart and that they improve the quality or length of diabetics’ lives, far tougher tests.
The Avandia story also begins a new and unsettling period for pharmaceutical companies because Avandia’s risks became known only after Dr. Nissen analyzed data from clinical trials that GlaxoSmithKline, the maker of the drug, had been forced to post on its Web site as a result of a legal settlement. Such public postings are increasingly the norm, which means that drugmakers can no longer easily hide or control scientific information about their medicines.
What should you do? Take charge of your health. If you are suffering from Type II diabetes, chances are good that you can at least free yourself from medication if not cure diabetes outright if you take charge (see this post: Diabetes Victory). Here are few posts I wrote previously for perspective on how you can control your health and life: Lunch Meat and Bacon the SAD Way (aka Promoting Diabetes and Alzheimer’s), With Every Bite You Eat… and A Corollary to “Every Bite You Eat”.
What does taking charge look like? Changing what you eat and monitoring the results with your healthcare provider. Taking this healing journey with the health of a good complementary and alternative medicine doctor is helpful. Here is a post regarding how to find one: How to Choose an Alternative or a Complementary Medicine Practitioner. Here is A Friend’s Life Changing Journey with Food if you want to see what starting this journey can look like.
What should you eat? Get rid of the processed food, most carbs,
including grain, sweeteners, potatoes, dairy (except certain cheeses and milk
that you ferment into yogurt and kefir) and beans (except navy, lima and
green). Drink lots of homemade bone broth, as shown in these videos:
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