August 05, 2005

Injecting through clothing

Now at http://www.healthcentral.com/diabetes/c/110/15837/injecting-clothing/

Bill the diabetesdoc

Diabetes.Blog.Com is a blogcompanion to our main website, the Diabetes Monitor, which you can find at www.DiabetesMonitor.com


*** Advertisement ***


Posted by Bill the diabetesdoc at 00:00:00 | Permanent Link | Comments (9) |

June 29, 2005

Time and e-health and diabetes

I am bemused by an article in Time magazine's June 27, 2005 edition, on page 55, titled The e-Health Revolution. It's available on-line at Time for a fee (but free at LexisNexis). In it, the author states:
A priority for McClellan [the head of Medicare/Medicaid] is to improve the treatment of diabetes and other chronic diseases, which absorb a disproportionate amount of health-care dollars. That requires better data collection--uploading and monitoring information from glucose meters, for instance--and more communication with patients.

Read further and you'll learn that
The U.S. is No. 1 in the world in terms of health-care expenditures--a total of $ 1.8 trillion last year and rising at a rate more than twice as fast as our incomes--yet it ranked no better than 16th in a study of 22 industrialized countries in what medical professionals call outcomes. That's in part because so much of the care delivered is unnecessary--as much as one-third, according to a Dartmouth study

I'm not at all sure what we, the average patient and the average doc, can do to hold down these amazing costs. But perhaps if you and I are at least aware of the problem, we'll look for more cost-effective ways of staying healthy.

And perhaps we'll stop asking for the best health care that somebody else's money can buy -- when we realize that it's actually our money that's being used, whether it's laundered through tax dollars, though inflated insurance premiums, or in smaller paychecks from our employers.

Bill the diabetesdoc


Diabetes.Blog.Com is a blogcompanion to our main website, the Diabetes Monitor, which you can find at www.DiabetesMonitor.com

At the Diabetes Monitor today: People with diabetes more sensitive to cardiovascular effects from air pollution

 




Posted by Bill the diabetesdoc at 00:00:00 | Permanent Link | Comments (1) |

June 22, 2005

Splitting pills

My local newspaper had an interesting story this morning: The 'split' decision: Some insurers back halving of pills as a way to save on costs. It brought to mind a previous article by my good friend, David Mendosa, reprinted at the Diabetes Monitor, pill-splitting.

If you are not splitting your pills, ask your pharmacist or physician about whether it's an idea that can save you money!

Bill the diabetesdoc


Diabetes.Blog.Com is a blogcompanion to our main website, the Diabetes Monitor, which you can find at www.DiabetesMonitor.com

At the Diabetes Monitor today: health problems in American Indian/Alaska Native women: diabetes




Posted by Bill the diabetesdoc at 00:00:00 | Permanent Link | Comments (0) |

June 16, 2005

Another interesting e-mail.

One of the joys of running a website is the oddball e-mails that arrive. I'd like to comment upon one interchange, that started with the following overexuberant hype about a new diabetes medication, which sounds like a sales rep's pitch to an unsuspecting physician:
Byetta
1. Weight loss
2. No risk of hypoglycemia
3. Postprandial glucose regulation
4. Self-regulating medication
5. No need for finger sticks
6. Improved beta cell health, possible regeneration
7. Forestalling or eliminating the inevitable progression to insulin dependence
8. Hope for a cure
9. FDA liked it so much THEY initiated a new NDA for use as a monotherapy!
What else would a diabetic want in order to consider Byetta?
My response:

"What else would a diabetic want in order to consider Byetta?" Well, perhaps not marketing hype such as you provide, but that their physicians are comfortable with the drug, and with its safety profile. Among other things needing clarification:

1) Documented long-term safety.
2) Pediatric safety
3) Mechanism of interaction with lovastatin:
"Exenatide reduced lovastatin AUC by 40%. This effect does not appear to be explained by delayed gastric emptying due to exenatide. We recommend that you investigate the mechanism(s) of the lovastatin-exenatide interaction..."
4) Understanding of its effects on other drugs:
"In addition, you should study how exenatide impacts the bioavailability of drugs that are instructed to be taken with food and thus may, by necessity, be taken in temporal proximity to exenatide."
5) clarification of interaction with BCPs:
"A human in vivo drug interaction study between exenatide and a combination oral contraceptive (e.g., ethinyl estradiol plus norethindrone) to define the effect of timing of the exenatide injection relative to the administration of the oral contraceptive on the bioavailability of the components of the oral contraceptive."

BTW, I'm an endocrinologist. Who are you, and why are you so "high" on this drug?

You are WRONG when you state "no risk of hypoglycemia." Per the label:
1) "when BYETTA was used in combination with a sulfonylurea, the incidence of hypoglycemia was increased over that of placebo in combination with a sulfonylurea. Therefore, patients receiving BYETTA in combination with a sulfonylurea may have an increased risk of hypoglycemia"
2) ODs: "One of the three patients experienced severe hypoglycemia requiring parenteral glucose administration."

and what do you mean by "5. No need for finger sticks"

(The quoted language in my responses 3, 4, and 5 is from the FDA Approval Letter, available at the FDA website.)

He never responded, despite repeated requests. I wonder if he learned anything from my reply, or continued in his blissful ignorance?

Bill the diabetesdoc


Diabetes.Blog.Com is a blogcompanion to our main website, the Diabetes Monitor, which you can find at www.DiabetesMonitor.com

At the Diabetes Monitor today: Reports from the ADA meeting: additional impressions.



Posted by Bill the diabetesdoc at 00:00:00 | Permanent Link | Comments (1) |

May 12, 2005

Oral insulin available soon - in Equador

As of June 1, 2008, the ability to post new comments at the Discussion Forums at Diabetes.Blog.com has been disabled. The old comments will remain available for you to read.

Please go to Diabetes Discussions to see new comments and to add your thoughts!

Instructions for posting comments may be found at Getting Started.

Thanks.

Generex Biotechnology Corporation has put out a press release indicating they have obtained regulatory approval from the Ecuadorian Ministry of Public Health to sell their proprietary oral insulin spray formulation, called Oral-lyn™. So people in Equador will soon be able to spray insulin into their mouths -- with no assurance of the safety of the product because no large-scale safety studies have yet been done.

Two small studies (on 44 patients) have been published showing that it works: Oral spray insulin in treatment of type 2 diabetes: a comparison of efficacy of the oral spray insulin (Oralin) with subcutaneous (SC) insulin injection, a proof of concept study (this study had 23 patients), and Beneficial effects of addition of oral spray insulin (Oralin) on insulin secretion and metabolic control in subjects with type 2 diabetes mellitus suboptimally controlled on oral hypoglycemic agents (this study had 21 patients). Elsewhere on the Internet, it is stated that the Equadorian approval was based on the results of clinical trials involving more than 250 patients with diabetes.

But the large-scale, costly Phase III clinical trials required by responsible regulators in the US, Europe, and elsewhere have not yet begun. These studies will involve well over a thousand patients, and must include a sizeable number of patients with over at least a year's exposure to the product.

Why did Generex make this announcement now, before doing any large-scale safety studies? Looks simple to me: according to Generex's CEO, "This approval will mark our transition from a development-stage company to one that will generate revenues from commercial sales." It looks like they need more money to do the big studies. Money from Equadorians, apparently.

I must respectfully disagree with the CEO's next comment, that "This approval will also enhance our ability to procure additional similar jurisdictional approvals around the world." There's simply no way that the FDA or European or other major regulatory agencies will be rushed into approval of a novel route of insulin delivery simply because people in Equador have access to it. Indeed, the other regulatory agencies will scrutinize both the unstarted Phase III safety studies they always require, and the outcomes of people using the product in markets where the product is already approved.

So, although I suppose you could book your airline ticket to Equador to get insulin oral sprays soon, I'd suggest you wait until it's been documented to be safe -- in large studies, and on the good people of Equador.

Bill the diabetesdoc

Disclaimer: I previously worked in pharmacovigilance (drug safety) for sanofi-aventis, who together with Pfizer, is working on development of another alternative form of insulin administration.


Diabetes.Blog.Com is a blogcompanion to our main website, the Diabetes Monitor, which you can find at www.DiabetesMonitor.com

At the Diabetes Monitor today: We're continuing a series titled Physical Activity for Everyone. Today: why should I be active?

*** Advertisement ***


Posted by Bill the diabetesdoc at 00:00:00 | Permanent Link | Comments (5) |