The FDA has approved a drug that proves a Gila Monster can be a diabetes patient's best friend.
Or, Gila Monster spit, to be exact. The reason: Byetta, known chemically as exenatide, is derived from a Gila Monster's saliva and it has now been given the green light by the FDA to become an injected option for Type 2 diabetics to control their blood sugar.
The Washington Post notes that, for now, it's supposed to be used with older drugs and not alone. More:
Some 18 million Americans have diabetes, the vast majority the Type 2 form, in which the body loses the ability to turn blood sugar into energy because it either doesn't produce enough insulin or doesn't use it correctly. It is closely associated with obesity.
When diet and exercise aren't enough to control Type 2 diabetes, patients can try certain oral medications to lower blood sugar. The most common, drugs called sulfonylureas, spur the body to produce more insulin.
When those drugs fail, adding Byetta to them offers patients a new option to try before resorting to injections of insulin.
Byetta is the first so-called "incretin mimetic," meaning it mimics action of a hormone called GLP-1 that's secreted by the gut to spur insulin production after a meal _ but only when blood sugar is high.
That's important, noted FDA metabolic drugs chief Dr. David Orloff, because other diabetes drugs spur insulin secretion even if blood sugar already is low, leading to the risk of hypoglycemia.
Byetta is a synthetic version of a protein found in the saliva of the Gila monster that works similarly to the human GLP-1.
The San Diego Union-Tribune has a great piece (which should be read in full) on Dr. John Eng, the researcher credited with the discovery. A small part:
Eng came across what he thought were very interesting studies done in the early 1980s by gastroenterologists at the National Institutes of Health, who noted that the venom in certain snakes and lizards caused inflammation of the pancreas, where insulin is made. Of particular interest was the hormone in the venom of the Gila monster.
Eng thought he had developed a test that would allow him to further investigate the lizard's venom. So he ordered some dried and preserved samples out of a catalog from a serpentarium in Utah...
In 1992, Eng's studies revealed that the venom contained two compounds, including one that had never been documented. He named it exendin-4.
The compound seemed to have properties similar to a human gut hormone, GLP-1, that was being researched around that time by scientists at Massachusetts General Hospital.
GLP-1 was exciting to researchers because it stimulates insulin secretion from the pancreas only when blood sugar is high, Eng said. When blood sugar levels are normal, GLP-1 seems to know not to stimulate insulin, the hormone that helps cells process blood sugar.
"That's ideal for treating diabetic patients," Eng said. "As a clinician working with diabetics, the struggle is to try and achieve as much glucose (blood sugar) control as you can to prevent bad complications like kidney failure, retinal disease that can cause blindness and nerve damage that causes loss of sensation in the feet."
But there is one hitch: there are some concerns about side effects, as The Street.Com details:
During an Amylin conference call Friday, the company exploded with a collective "woohoo!" But some analysts didn't see much to holler about yet.
Mark Schoenebaum of Bear Stearns is concerned that "twice-daily injections and [side effects such as] nausea will be a hindrance to rapid adoption and that the upper end of Street expectations will need to be reined in." Bear Stearns says it's a market maker in Amylin's securities.
PERSONAL NOTE: My grandfather Abraham Ravinsky had diabetes and used to monitor it and do all the treatments himself. When he died, it was not due to his diabetes. But over the years I've known many people with diabetes, two of whom (a journalist and a ventriloquist/magician) died of complications that turned fatal once they developed problems with their feet. This is great news for diabetes patients. And it also suggests that the spitting mad Gila Monster may be here for another reason..
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