The FDA, blindly, at work
In 2004 I began alerting those I knew who were living with diabetes to the extreme risk of cardiovascular events if they were using Avandia. Sadly, many were. I encouraged them to take the information I provided to their healthcare provider for discussion.
At that time this information was suppressed. It wasn’t until late in 2007 when this information was picked up by mainstream media and it became widely publicized. A Black Box warning was applied to the drug’s information. The manufacturer, GlaxoSmithKline, agreed to pay some $3 billion in damages to no less than 83,000 people who had experienced heart attack and stroke. Adding insult to injury, the FDA allowed the drug to continue to be used in ‘select’ cases.
Dr. Steven Nissen of the Cleveland Clinic warned of the high rate of risk (43%) for increased cardiovascular events in his 2007 article published in the New England Journal of Medicine.
At that time GSK defended the drug, yet in 2010 agreed privately in communication with the FDA that Dr. Nissen’s findings were accurate.
Nissen has often called for needed change at the FDA.
Most suggested replacing Avandia with the diabetes drug, Actos, manufactured by Takeda. Following on in a similar post marking revelation scenario, Actos was found to be a causative factor in the development of bladder cancer, especially for people who has been taking the drug for at least two years. Later, scientific studies determined that Actos could also cause cardiovascular events and fractures. FDA then required a Black Box warning for this drug as well.
Avandia is rosiglitazone; Actos is pioglitazone. These are synthetically created pharmaceutical agents. Both drugs can lead to congestive heart failure. More clinical information can be found at Rxlist.com.
Now comes a new drug, Bydureon (exenatide extended release), manufactured by Amylin Pharmaceuticals. This long-acting form is a version of their diabetes drug Byetta, that can be used weekly. Byetta is a synthetic exenatide formulation with risk for severe allergic reactions affecting the skin and respiratory system as well as pancreatitis and kidney disease.
Now approved by the FDA (U.S. Food and Drug Administration) this newer drug comes with a label warning that the drug caused certain thyroid tumors in rats.
There has been no information provided by the manufacturer whether the drug causes these tumors in people. The warning does state that the drug should not be used by people with history of medullary thyroid carcinoma (cancer). And to think, it was the early pioneers in endocrinology that believed strongly that diabetes was a thyroid disorder.
In 2010 the FDA denied approval of Bydureon and requested additional studies and clinical data.
There is much to be seen from yet another synthetic and potentially risky drug. All drugs in this class have potential interaction issues with other prescriptions you may be taking. Make sure your prescriber and/or your pharmacist provides you with this information, and you clearly understand it.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Of course there seems to be no effort to provide you with information about what you can do with nutrition and natural herbs or nutritional supplements and exercise to help you prevent and reduce or eliminate diabetes. Feel free to ask these questions the next time you visit your health care provider.
NB: Generally these drugs are very costly. Here is some cost data and comparison shopping information. In 2007 GSK spent more than $8 million on lobbying efforts to federal agencies and members of CONgress.
Coming soon: Our new book, The Diabetes Diary, will have more than 100 pages of natural health information for diabetes.
2 February:
Updating this discussion, just this week, a new medical report was issued raising some concerns about the key anti-diabetic drug Metformin.
Metformin is known to cause depletion of Vitamin B12 but this was not the core material in this new study. The study looked at several drugs used to treat diabetes Type 2. They found that especially in men there was a stronger correlation to the disease. Other drugs noted in the study that raised this risk were insulin and the drug class ‘sulfonureas’.
Insulin is noted to increase the risk of cancer, especially the genetically engineered ones such as Lantus.
You can read more here from the UK edition of Reuters.
