E-Articles - Health and Fitness

Do you sometimes feel like food is the enemy? If you’re overweight, the odds are high that you view food with deep suspicion. But even if you’re not overweight, you might have the same dim view. Many normal weighted people do.

Defining food as the enemy

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

can only lead to unhappiness and problems, according to obesity experts. When you think about it, it’s to your advantage to put a friendly face on food because you can’t get away from it. You need food to live. Food is energy and is the fuel that runs our

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

Examples of combination products may in

bodies. Food is a necessity – without it we become ill and eventually cease to live. Wanting to eat and needing to eat is not a judgment call, it’s part of being human.

So what does a healthy relationship to food look like? You recognize you have a need

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

for food and you feel good about filling that need. This contrasts to the food-as-enemy viewpoint where your self worth is determined by how little you eat.

You may be surprised to discover that someone with a healthy relationship to food can and does ea

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

healthy food, but also occasionally enjoys a treat food like cake or cookies. The richer, calorie dense foods are actually enjoyed by someone with a healthy relationship to food, and they don’t put themselves down for eating it. Imagine that. It’s when t

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

Combination pro

e majority of our food is of the treat variety without substantial nutrition, and when the majority of our enjoyment and comfort comes from food, we’ve flipped to the unhealthy side of the spectrum.

Dr. Caroline Cederquist, bariatric physician and medica

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

l director of the Cederquist Wellness Center in Naples, Florida, points out that our relationship with food, be it healthy or not, is often determined by our body chemistry.

“A lot of people in my practice have a constellation of symptoms that we call in

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

ulin resistance,” Dr. Cederquist explains. “Insulin is the hormone that gets the blood sugar into the cells to be utilized. If someone is resistant to their own insulin, the body compensates by secreting extra insulin and the extra insulin present in the

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

blood causes the person to change metabolically.

“Insulin aids fat storage and the more insulin you have, the better you store fat.” Dr. Cederquist points out. “I’ve always believed, and now we have scientific proof, that if you are insulin resistant or

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

re a diabetic, you have a lowered thermic effect of food. That means if you’re insulin resistant and I’m not, if you and I eat the same meals with the same calories, I will burn more of those calories than you will.”

Dr. Cederquist explains if someone is

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

insulin resistant and they eat a high carbohydrate meal like a bagel, the bagel is easily digested and quickly turns to sugar. Insulin is then secreted in over abundance. This causes a sharp rise in blood sugar level followed by a dramatic plunge. Ravenou

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

Following aspects would a

s hunger automatically follows this cycle.

“It’s so important to know that you can’t willpower away physiological symptoms, but you can control them by eating in a helpful way,” Dr. Cederquist says. She encourages her weight loss patients to eat small am

dd to the challenges in developing combination products:

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

unts of protein spread throughout the day in order to stabilize blood sugar. She helps patients understand how helpful it is to be aware of the type of carbohydrates they are eating, to eat more fiber and to eat fruit rather than fruit juice in order to k

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

eep blood sugar under control.

One of the easiest ways to develop a healthy relationship to food is to eat the types of food that will keep your blood sugar steady so you avoid feeli

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

g ravenous. “If you eat sugar when you’re insulin resistant, then you’re going to crave more sugar, “ Dr. Cederquist notes. “This creates a roller coaster effect of your blood sugar level and you have less and less control over your food choices. This ero

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

es a healthy relationship with food because when your body is on a biochemical roller coaster, you truly cannot control your food choices.”

Yet people end up putting themselves down and think

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

Professional from academic institutions, pharmaceutical industries, health care indust

they are horrible and without willpower when they feel out of control because their blood sugar fluctuates. Dr. Cederquist emphasizes that it’s not a question of being a bad person or lacking willpower, it’s a question of having a physical reaction to eat

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

ng food that triggers irregularity in blood sugar levels.

Dr. Cederquist counsels not to view foods as bad or wrong, but rather to focus on foods that will benefit you. Nonetheless, even while her patients are actively losing weight she encourages them 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

o have one meal a week when they eat everything and anything they want, including dessert. She feels it is empowering to view any food as acceptable and none as forbidden, but to keep certain foods as treats and not a regular part of your diet.

The good

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

Companies that provide selfless information through particip

ews is, according to Dr. Cederquist, it’s absolutely possible to develop a healthy relationship with food. She’s witnessed patients making the switch countless times. These patients are slimmer, healthier and happier as a result. Just like you can be!

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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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