Advice Pool - Health and Fitness

When is it alright to get half your daily calorie intake from saturated fats? Answer: When you follow a new diet for diabetics promoted by Dr. James Hays, and en

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

docrinologist in Wilmington, DE. Dr. Hays and others are conducting new studies into diabetes treatment and the results are now making the rounds on the Internet, in jou

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

nals, and special reports.

Let us back up a little so you will get a brief background of where I am going with this. As you know, diabetes mellitus is a condition that

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

esults from either a lack of hormone insulin in the body (type 1 diabetes) or where the body has sufficient insulin but the body cannot use it (type II diabetes).

Con

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

entional wisdom among medical practitioners who treat diabetes, has been to reduce sugars in the patient's diet, but keep a steady intake of starches such as bread, potat

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

, rice, pasta and so on. Fruits and fruit juices are usually recommended because it is thought that the fructose from fruit sugar does not raise insulin levels. No

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

here comes Dr. James Hays from the Limestone Medical Center in Wilmington, Delaware with proof that practically drags conventional wisdom kicking and screaming out the d

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

or.

Dr. Hays contends that diabetes mellitus is a chronic disorder of carbohydrate metabolism. For people with diabetes, this spells relief in their treatment an

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

certainly, a major shift in their diet. His results differ dramatically from those achieved from the long-promoted diets of reputable sources such as the American Diabet

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

s Association and DiabetesUK. These are umbrella bodies for the treatment of this disease.

In the case of diabetes treatment, Dr. Hays's study seem to throw a wrench int

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

the wheel of often-quoted instructions to diabetic sufferers regarding diet. This report has the "audacity" to suggest that a person with type 1 and type II diabetes sh

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

uld eat a diet of very high fat, and very low carbohydrates. In promoting the use of fats in the diets of diabetics, Dr. Hays even includes saturated fats, as found in m

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ats. His results from his study group which whose members were monitored for one year were impressive. Here are a few extracts:

1. Patients experience a mean de

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

line in total cholesterol.
2. LDL (bad cholesterol) fell by over 25 mg/dl
3. HDL (good cholesterol) increased by 3 mg/dl
4. Triglycerides declined by ov

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

r 44 mg/dl

Here is the funny part of this report. I don't mean funny in the usual way; just a little strange. Most doctors preach to their diabetic patients

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

hat they MUST maintain low-fat diets with no departure from their instructions, or else! Not so with this group. They maintained their high-fat diet and this group of p

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

tients included at least 3 cardiologists to boot!

People will always gravitate towards a good thing when they see it. The conclusion of the study, of course is that thi

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

diet resulted in weight loss, lower cholesterol, and better lipid profile in each patient. There goes conventional wisdom flying out the door again. If you have a diet

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

that results in weight loss, lower cholesterol, and a better lipid profile, eventually, every other diabetes patient will be eating that way. Conventional wisdom is not

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

lways sound, and in this case could probably send a diabetic patient to the grave earlier than necessary. It certainly seems like a second opinion is always a good thing

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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