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Medical experts say that they want their patients’ treatment to be “evidence-based” – that is, chosen on the basis of good research studies. They are often critical of complementary and alternative medicine (CAM) because of the lim

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

ited research available by mainstream Western medical standards for any particular treatment.

The trouble is that it is hard even for doctors, let alone consumers, to figure out whether a treatment is good or bad in a particular c

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

Examples of combination products may in

ase. This problem affects not only treatments with mainstream drugs, but also with the many different types of CAM. Especially in CAM, practitioners usually try to individualize the treatment for the unique physical and psychosoci

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

al situation of the person as a whole. What makes it so hard to tell if a treatment might be “good” or “bad” for you?

First, research studies are not individualized; rather, scientists typically do their studies on large groups of

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

people – and then scientists average the results over everyone who participated. So, group averages do not tell doctors very much about what will work for you as the individual in front of them in the office. And the formal resear

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

Combination pro

ch testing doesn’t always tell them the possible interactions between the treatment and other factors – other medications, natural products, other conditions you may have that the research study participants didn’t have, genetics,

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

environmental exposures – that can each increase or decrease the effectiveness and/or the safety of the treatment for you.

In short, research evidence often doesn’t give your doctor - or you - the information he or she needs to de

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

cide whether or not a treatment will be good or bad for you in your particular and unique situation. Advice of friends and family, as well as health food store clerks, can sometimes be helpful, but they usually only know what worke

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

d for them. You can’t know if you will have the same or different result.

Second, the results of any research study are most relevant to the precise conditions under which the scientists tested a particular treatment. For example,

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

most “good” research studies recruit patients who have fewer health problems and use fewer drugs than the average patient in a doctor’s office. Studies also focus on a specific outcome for a short period of time, usually an outcom

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

that is relevant to the patients’ disease, not to the patient. And they observe for 8-12 weeks or so.

If scientists test a treatment’s effects on persons with headaches for 12 weeks, but the CAM treatment helps other symptoms (no

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

Following aspects would a

t headache) get better, improves overall energy, and gives them a greater sense of well-being in 12 weeks (but has little effect on the headaches until week 20 or later), the conclusion will be that the treatment “doesn’t work.”

M

dd to the challenges in developing combination products:

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

eanwhile, CAM practitioners and patients are puzzled and even outraged to hear the results - because of the contradictions between the research conclusions and their own experience in the real world. But in the real world outside o

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

f a research study, the practitioners and patients were able to look at more than the headaches, and they were able to allow the treatment more than 12 weeks to work.

Third, people who do and don’t use CAM differ in their personal

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

ity type. People who choose to try CAM treatments score higher than CAM non-users on the trait of openness to experience. Openness is one of the five major dimensions of personality, along with extraversion, conscientiousness, agre

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

eableness, and neuroticism. Other research has shown that people high in trait openness may have not only a different psychology, but also a different biology and genetics, than people low in that trait.

If a research study happen

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

Professional from academic institutions, pharmaceutical industries, health care indust

s to recruit a lot of people who are low in trait openness and a CAM treatment doesn’t work during the study, the results could be valid – but not relevant to the majority of people who actually use the treatment in the real world,

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

outside the research study.

For now, the bottom line is to use common sense. If doctors and other experts haven’t found any serious side-effects of a CAM treatment and your own health care providers don’t see any significant risk

.

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

s for you with your unique health issues - and some people find the treatment helpful for problems like yours - consider trying it. Continue it if it helps; stop it if you get worse or develop a new problem.

And keep educating you

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

Companies that provide selfless information through particip

rself about your health care treatment options – empower yourself with information. Don’t expect your doctor or other health care providers to have all of the answers or for any one research study to give them or you the final word

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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