Diabetes & Byetta

Ev,
Here is something I copied from Dr Mendosa’s website. I find this article
interesting and informative. Hope it helps you.
Pam

That’s the conventional wisdom. Yet just one person, Dr. John Eng, is
responsible for the discovery of Byetta. The Food and Drug Administration
approved this powerful new diabetes medication on April 29, 2005.

One of those giants was Dr. Eng’s mentor, Dr. Rosalyn S. Yalow, who won the 1977
Nobel Prize in Medicine for the development of radioimmunoassays of peptide
hormones. After becoming an endocrinologist, Dr. Eng wanted to do endocrine
research and worked in her lab at the VA Medical Center in New York for 18 years
until she retired.

"The first hormones that were discovered were those in the greatest abundance,
like insulin," he said. "In research we always want to find something new, and I
am no exception."

He thought that there might still be hormones out there waiting to be
discovered. Radioimmunoassays couldn’t help Dr. Eng find them, because those
assays aren’t a good way to discover new hormones. But there were other
shoulders for Dr. Eng to stand on.

So Dr. Eng decided to use chemical assays to look for the new hormones that he
thought were out there and that he so much wanted to find. But where to look?

He found a sequence never before described. One of his responsibilities to
science then was to name it. Since it is an EXocrine secretion that has an
ENDocrINe function, he named it exendin.

Then Dr. Eng had to show that exendin had biological activity. "Otherwise, it’s
just another peptide."

But GLP-1 itself breaks down in a matter of minutes, so the only way that we
could use it would be by a continuous infusion drip. Not fun.

The form of exendin that Dr. Eng synthesized from the Gila monster, however,
stays in our bloodstream for hours. It then became clear to Dr. Eng that it
could be a valuable medication for people with diabetes.

So he tried to get the Veterans Administration, where he has spent his entire
career, to patent his invention. But at that time the VA was only interested in
patenting inventions that were specific to veterans, like spinal cord injury,
loss of limbs, or prostheses.

"That put me in a difficult position," he told me, "because it meant I had to
essentially make a bet. Patenting it came out of my pocket with no guarantee
that anything would come of it."

All along the way the Byetta story has been full of ironies. One of the first
was the fact that while Lilly turned down the chance to develop Byetta alone, it
was the company that Amylin turned to in order to jointly market it.

Another is that Dr. Eng had never seen a Gila monster when he invented Byetta.
It was only a year or two ago that he finally got to see one, he told me when we
talked again this week. He was in a film about Gila monsters made by a wildlife
expert in England that U.S. public television showed.

One of the strangest ironies is that none of Dr. Eng’s research articles or his
patent on extendin even mention the weight loss that it often leads to. I asked
him this week when he first realized that it could lead to weight loss.

"I didn’t," he replied. It was only in the Amylin’s Phase 3 trials that the
weight loss became apparent.

Finally, Dr. Eng told me that he hasn’t been able to prescribe Byetta. He can’t,
because it isn’t in the VA formulary. "That’s ironic," he says.

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