Advice Pool - Health and Fitness

Hearing loss is a hidden disability. As such it doesn’t get the political and financial support that more obvious handicaps receive from government and private organizations. Hearing

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

loss is the number one disability in the world as well as the number one birth defect among infants . . . and yet, nothing has really been done about it.

Blind children learn to read

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

Examples of combination products may in

Braille and graduate from high school at the same reading levels as their sighted peers. Deaf children even with help of American Sign Language generally graduate at the fourth grade

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

level.

What starts out as a hearing problem is really a communication problem. If you’ve never heard, you don’t know what words sound like, so you can’t speak. If you can’t speak, yo

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

can’t hear, you can’t read, and can’t write, how can you communicate? How can you get a job? The answer is they don’t.

Combine the birth defects problem with hearing loss from a noi

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

Combination pro

sy world and the loss of hearing as we grow older and you have a major problem. Even if a problem is hidden, it’s still a problem. And it won’t go away.

When severely hearing handica

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

ped Clover Park Rotarian Gene Pankey learned about research underway to restore hearing by re-growing inner ear hair cells, he put into action what today is known as Rotarians for He

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

aring Regeneration (RfHR: www.hearingregeneration.org). What better way to tackle a world-wide problem than to address a world-wide organization? Several decades ago Rotary began work

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

ng for the elimination of Polio. Today that goal is just about realized.

Handicapped since a childhood by total hearing loss in one ear, Pankey suffered hearing loss episodes in his

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

good ear. That brought him into the realm of those involved with research underway at the University of Washington in Seattle.

Research has discovered that birds spontaneously re-gro

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

inner ear hair cells, thus restoring their hearing. That research has provided a dawning of Rotarian involvement. The small group of Rotarians decided to try helping researchers by e

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

Following aspects would a

ducating Rotarians and others about the possibilities of restoring hearing in mammals by regenerating hair cells. The thinking is, “If birds can do it, why can’t we?”

Pankey, Rotary

dd to the challenges in developing combination products:

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

istrict 5020 Past District Governor Dave Sclair, and Dr. David Cotant, also a Clover Park Rotarian, formed today’s RfHR and set about trying to educate Rotarians and help raise 20 mil

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

lion dollars to support the research program.

Education efforts have included a PowerPoint show, an 11-minute video, brochures, and making numerous presentations to clubs, conference

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

, and a booth at the 100th anniversary Rotary convention in Chicago.

Today, RfHR has members all over the United States and several other countries. Approximately 2,000 copies of the

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

video – Hope For Hearing Loss: The Hearing Regeneration Initiative – have been distributed. An updated version of the video is in the works. Fundraising has continued without interru

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

Professional from academic institutions, pharmaceutical industries, health care indust

tion and more efforts are planned.

RfHR has joined forces with the Hard of Hearing Hall of Fame (www.hardofhearinghalloffame.com), which is dedicated to recognizing achievement from

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

the hearing impaired and educating people about hearing loss, thereby reducing hearing problems.

Research funds are still far from the overall goal, but all donations help. 2006 saw

.

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

atching funds cover half a million dollars, and in 2007 there are matching funds available for the first million donated. RfHR hopes its publicity and education campaigns result in ad

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

Companies that provide selfless information through particip

equate funding that allows research to move ahead quickly. Hearing loss should not be hidden. By recognizing it, we may soon unlock the secrets of hearing loss and hearing restoration

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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Advice Pool - Hearing Loss: The Hidden Disability

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