Summary - Health and Fitness

Here we go again... more confusing news. I can hear the rumbling frustrations of the millions of women who have been diligent with their calcium supplements in the belief that it helps prevent osteoporosis; a dangerous, sometimes crippling conditi

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

on primarily associated with post-menopausal women.

In recent news, it was suggested that perhaps all those years of religiously taken your calcium supplement may not have done much good. A report published in the New England Journal of Medicine

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

Examples of combination products may in

Vol. 354, pp. 669-683) is the source of this recent hubbub. The study organizers followed more than 36,000 women, and they have concluded that supplementation did not actually improve the risks of hip fractures during the course of the study. But the ne

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

s report is quite misleading.

The study focused on calcium and vitamin D supplementation, and concluded that although they did record an increase in bone density, they did not notice any substantial difference in actual hip fractures over t

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

e course of seven years. However, my concern with this broad generalization is the same concern I had in all the years of the “experts” telling women just the opposite; they CAN minimize their risk of osteoporosis by taking a calcium supplement. The bot

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

Combination pro

tom line is... it is just not that simple, but how we wish it were.

As is the case with many health issues, there is no such thing as a magic bullet. Consider any sub-standard health condition and you know that there is no “one size fits all”. L

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

festyle choices, hereditary issues and environmental factors often conspire against achieving wellness. And this “calcium push-pull” is a classic example.

For many years, I have answered questions from our customers asking about calcium supplementation;

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

should they or shouldn’t they. I usually begin my response by asking a lot of my own questions about their personal habits, general health condition, specific symptoms or concerns, and desired outcome or goals. When I receive an inquiry about calcium su

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

plements, I begin my response by verbalizing a rhetorical question:

“Why do you suppose it is that after several decades of doctors recommending that women take calcium supplementation to prevent osteoporosis, we continue to have an ever increasing rate

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

of osteoporosis in our aging population?”

Even though a rhetorical question should not be answered, I am going to answer it:

“It is because the issue is much more complicated than simply popping a pill.”

This is one of those times when I tell people to

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

“read between the lines”. What else is going on here to affect the results the subjects received in the study? Could it be lifestyle, environmental factors or heredity? Yes, of course.

Heredity is an issue that might be answered at the beginning with

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

Following aspects would a

uestionnaires about family history that might suggest a predisposition to a specific ailment. A well-conducted study would likely have accounted for that. However, what I am unsure of are the other two factors.

Lifestyle and Environmental factors (or w

dd to the challenges in developing combination products:

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

at I call Dimensions) are what I primarily focus on when I am responding to questions about calcium supplements. Within the Lifestyle Dimension, I would include exercise habits, consumption habits or indulgences, and mental stress conditions, to mention

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

a few. Within the Environmental Dimension, I primarily discuss food quality and toxicity levels that may be present in your surroundings.

The reason I focus on these other Dimensions is because it hints at the complexity of the whole calcium debate. My

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

point is that since we know that osteoporosis has been an increasing problem for many decades (despite the early declarations that calcium supplementation is the key), perhaps we should be paying attention to not only how much calcium is going in b

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

t also how much calcium is going out. In other words, what is contributing to an increasing rate of calcium depletion? Why is the mineral calcium being compelled out of the bones and vanquished from the body?

My purpose for mentioning these topi

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

Professional from academic institutions, pharmaceutical industries, health care indust

s now is to encourage a wider perspective when you are questioning the meaning of the results for this latest calcium study. We have always been proponents of high-end calcium supplements, but only as a part of the greater whole. Calcium will only benef

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

it someone when they carefully select a quality form of calcium as one piece of the very complex puzzle. Further, someone must consider several contributing factors when developing a plan to combat the risks of osteoporosis.

And when you are pondering t

.

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

e claimed results of this study, remember to step back and read between the lines. If you currently are on a calcium supplement, continue taking it. In subsequent segments to this series I will help you to understand why.

In "Calcium: Another Perspecti

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

Companies that provide selfless information through particip

e – Part 2", I will cover in more detail some of the topics within the Lifestyle and Environmental Dimensions that can affect calcium absorption and depletion. And there will be some additional comments on the publicized results of this most recent study

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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