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April 30, 2005

Lizard-derived type 2 diabetes drug approved

Lizard-Derived Diabetes Drug Is Approved by the F.D.A. [NYT permalink]

A diabetes drug derived from a poisonous lizard has been approved by the Food and Drug Administration, its developers, Amylin Pharmaceuticals and Eli Lilly, said yesterday.

The drug, called Byetta, will be the first in a new class of drugs to reach the market for Type 2 diabetes, the form that usually occurs in adults. Studies have shown it can help control blood sugar and also help people lose a few pounds. The drawback for patients is that the drug must be injected twice a day and nearly half the people who use it suffer nausea, at least initially.

Analysts have said Byetta could achieve sales of hundreds of millions of dollars a year, or even more than $1 billion. Those sales could propel money-losing Amylin, a biotechnology company in San Diego, to profitability. Lilly, a drug giant that is already a leading producer of insulin, could further bolster its presence in the diabetes drug market.

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"and nearly half the people who use it suffer nausea, at least initially."

I wonder if they can start off by taking a very small dose, at least initially, so their bodies can get used to it?

Please tell me if I'm wrong about this, but it seems to me that doctors (or maybe its the pharmaceutical comapnies) have a bias against prescribing very low doses of certain drugs. My best friend just tried to quit smoking so she got a prescription to the generic of Wellbutrin. The drug hit her hard and she had to discontinue after 3 days. She said it was a lot like dropping acid, and she suffered bad physical forms of anxiety, especially tightness in the muscles. She suffered muscle spams in her legs that were so bad she was still walking with a limp 3 days after she stopped taking the drug. She started off taking half the normal dose, but my friend weighs only 105 pounds, so for her, starting by taking "half" dose was more like starting off taking a full dose.

I wonder why drug companies don't make drugs in smaller doses? More people would tolerate anti-depressents if they could just take a small dose of it. Why the all-or-nothing approach, I wonder? With antibioitics, the all-or-nothing approach is important because too low a dose merely allows bacteria to develop resistance, without killing the bacteria. But there is no reason that I know of to take an all-or-nothing approach with most other category of drugs.

Those who know better than I can relieve me of my ignorance on this point.

Lawrence, I sat in on an investor presentation once about Byetta and, as I recall, there is no good way of dealing with the nausea, but nausea is apparently a common response to starting an injected therapy since there was also a fairly high rate of nausea in the control arm.

More generally, here is an interesting article about the partnership: http://www.post-gazette.com/pg/05117/495048.stm

I guess it's a good thing that Gila monsters aren't GRAC.

Well, an Rx for Compazine will take care of the nausea. And as for the convulsions that are a side effect of the Compazine? Nothing that a little Benedryl or a short hospitalization won't take care of. The important thing is that the Big Pharma's bottom line is protected.

Of course, we could just do something about the soft-drink industry and high-fructose corn syrup(http://tinyurl.com/86jd2) but that would be kinda socialist, wouldn't it?

Those who take metformin, also a diabetes type II drug, and who also suffer from nausea as a result sometimes get relief by eating yogurt--make sure it's the kind with the little live thingies in it.

I believe there's a UK study indicating yogurt alleviates nausea in some patients on high doses of antibiotics.

So maybe yogurt would work with the gila monster stuff.

Brautigan, I take your point about the fast food and soft drink industries, not to mention Big Pharma. Still, diabetes has existed for millenia, long before soft drinks or fast food could have been a factor in its cause.

The thing that bothers me about your post is that it seems to suggest that developing drugs to treat type 2 diabetes is wrong, or wasteful, because it would be better to prevent the disease. It's certainly true that prevention would be better, but there is no sure-fire way to do this. Not all diabetes -- not even all type 2 diabetes -- is associated with obesity. Not all diabetes -- not even all type 2 diabetes -- can be prevented with lifestyle changes. There are other factors at work. Type 2 diabetes is a complex disease; in fact, it's really a catch-all term for any diabetes that is not type 1 diabetes, which is a relatively well-understood and easy-to-define condition. This drug sounds unpleasant enough that most people would not want to take it if there were an alternative. Presumably that means that it treats an aspect of the disease that no other drugs on the market treat. It's possible that it could be a good choice for people who find that no other drug or lifestyle change works to control their disease.

? is cvs selling byetta and what is the price.

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