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Chronic or late disseminated Lyme disease is the third stage of this multi-system, multi-stage illness. Various factors may contribute to chronic Lyme disease. Not all people infected with the Lyme bacteria develop the same symptoms, and a correct diagno

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

sis is difficult. Chronic Lyme disease can occur when people have not been properly diagnosed or treated, or if they have received inadequate treatment. If all of the bacteria that cause Lyme disease are not killed off, the illness can move into a chroni

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

Examples of combination products may in

stage, resulting in many other conditions including rheumatoid arthritis, chronic fatigue, poor concentration skills and more.

Patients who are diagnosed immediately after getting infected seem to have the best chance of quick and complete recovery whe

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

n they begin antibiotic treatment immediately. Yet Lyme disease, which has been nicknamed the Great Imitator, can mimic the symptoms of at least a hundred other medical conditions. Unsuspecting patients and their physicians simply may not know which test

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

to administer in the face of so many possibilities. Lyme disease is so often misdiagnosed that if and when the patient does eventually receive a correct diagnosis, their condition may have already become chronic.

According to some medical experts, if t

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

Combination pro

he Lyme disease patient does not receive antibiotics for a long enough period of time, the symptoms may become chronic. Misdiagnoses can contribute to chronic Lyme disease when doctors subscribe medications for diseases or conditions they believe their p

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

tients have, but in fact they do not. This can have disastrous results. For example, the use of corticosteroids will replicate the spirochetes (bacteria) that cause Lyme disease. Therefore, steroids are to be avoided where Lyme disease is suspected, and

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

they are contraindicated. Some Lyme-literate doctors believe that steroid use while Lyme bacteria are present will cause chronic Lyme disease. But, ignorant of the possibility of Lyme bacteria, Lyme-illiterate MDs have mistakenly prescribed steroids to c

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

ntrol inflammation, with calamitous results for their patients.

Many people who have been labeled with another chronic disease such as Lupus, Multiple Sclerosis, Fibromyalgia, Parkinson’s and others, may indeed have a condition that could be effectively

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

treated with antibiotics. Lyme bacteria may be the underlying cause of their current condition, or at least a contributor. Many MDs are Lyme-illiterate. This is unfortunate considering the alarming rise in the number of proven Lyme disease diagnoses. In

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

urious doctors may simply never suspect infection and therefore, never administer a test for Lyme disease or one of the many co-infections with which it is frequently associated. They may go on wrongly treating a misdiagnosed patient for years. The patie

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

Following aspects would a

nt, for their part, may continue being sick with chronic Lyme disease, never understanding why the medicines they consume aren’t making them any better.

Rampant misdiagnoses, unreliable tests and contentiousness between medical experts regarding the cor

dd to the challenges in developing combination products:

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

ect treatment of Lyme disease has created a milieu wherein patients are typically aware that they must advocate for their own healing path. But how can Lyme disease patients advocate the best treatment for themselves if they remain ignorant of the underl

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

ying cause of their illness? And why are many medical experts ignorant of, and uninformed about, this rapidly spreading disease?

Medical insurance constraints on long-term treatment of chronic Lyme disease contribute to the problem. Many clinics, doctor

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

and hospitals are heavily lobbied by wealthy insurance companies who refuse to acknowledge the evidence put forth by Lyme-literate experts that long-term care is necessary for treating chronic Lyme successfully. Many MDs simply adhere to the stringent p

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

rotocol of this damaging disease posited by the Center for Disease Control (CDC).

Typical CDC protocol followed by many uninformed, Lyme-illiterate MDs calls for the administration of a 30 day course of antibiotics, and assumes that the bacteria will be

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

Professional from academic institutions, pharmaceutical industries, health care indust

killed off and the patient recovered by the end of the course. In some cases this is probably sufficient. But given the extremely complicated nature of a correct diagnosis, the varied symptoms of Lyme disease patients, and the confusion of MDs over how b

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

est to treat Lyme, it’s little wonder that in most cases, 30 days of antibiotic treatment does not cure the patient. In fact, according to one line of Lyme expert thought, this course of treatment is to blame for the disease moving into a chronic stage.

.

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

Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAV

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

Companies that provide selfless information through particip

E A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.

Copyright © 2005 Suzanne Arthur. All rights reserved

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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