Actual - Legal

A Living Will, also known as a Healthcare Directive or Advanced Health Care Directive, is a legal document used to specify the healthcare or life support you would like to receive under certain conditions. If you are admit

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

ted to the hospital you will probably be asked if you have a living will. It is different from a Last Will and Testament, and does not take the place of one.

Because humans fear death, we try to prevent our own demise eve

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

Examples of combination products may in

when it is inevitable—even when it is in the soul’s best interest to leave this earth plane. With life saving equipment and mechanical life support, it is possible to thwart the natural process of death and suspend life.

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

ew people realize that this process may actually tether a spirit to the body and keep the loved one’s soul from moving on to the next adventure in the Afterlife.

I completed my book about death and dying, and was going to

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

print about the time the media began pumping out news regarding the passing of Pope John Paul II and Terri Schiavo’s suffering. The Pope requested to not be placed on life support, while Terri’s family refused to allow her

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

Combination pro

to be taken off. Both their stories touched a place in my heart because I’ve experienced similar circumstances first-hand.

My grandfather refused life support or measures to resuscitate when he was dying of emphysema. Whi

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

e he struggled to breathe, we knew there was nothing his doctor could do to give him back his health. He felt his spirit was ready to depart, so my family honored his wishes and stood by him as he drew his last breath.

Li

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

ke Terri, my uncle’s soul was a hospital hostage—his torture lasting for one year. While his body was on life support, his spirit came to me, asking for my assistance to help our family understand that he wanted to leave t

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

e earth plane. The healthcare directive he had in place allowed his wife and doctor to make medical decisions regarding resuscitation and life support, so there was legally nothing I could do. Besides, how could I tell my

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

unt that I had talked to my uncle’s spirit and that he wanted to leave? How could I tell her that he had changed his mind about his code status and wanted to be taken off life support? His final days were spent in coma and

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

his spirit again came to me—this time to ask me to sing and play a particular song for his funeral. I agreed and wished him well in the Afterlife. Fortunately, on the fifth day of his coma, my aunt finally allowed him to b

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

Following aspects would a

unplugged from life support. I was not surprised when I got the call and was told that my aunt wanted me to provide music for the ceremony. I did not know my uncle well enough to know his tastes in music, so I was surpris

dd to the challenges in developing combination products:

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

d when the song my aunt asked me to use was the same one my uncle had given me in my meditation. I don’t blame my aunt for her decision; she was simply exercising her legal right provided by my uncle’s living will. She w

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

s not ready to let him go. I’m not sure if she could have pulled the plug before the fifth day or not, but this decision is something she should not have been burdened with. No one else wants to decide the fate of another

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

human being, especially someone they love! My uncle’s preference not to be on life support for more than “X” number of days could have been clearly stated in his living will.

While life support is a wonderful tool for hel

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

ing someone remain alive while the body heals enough to return to a meaningful life, the practice of keeping people artificially alive is overused and many doctors are afraid to tell the patient’s family that there is noth

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

Professional from academic institutions, pharmaceutical industries, health care indust

ng more that medical science can do for their loved one. Many doctors are simply not trained to assist families with the emotional and legal issues about the dying process. Therefore, I encourage you to make a living will

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

OW and ask someone to facilitate who is able to carry out your desires even under emotional pressure. This will help you avoid being put through the misery (yes, it is painful to be on a ventilator!) of being on life suppo

.

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

t if your wishes are otherwise. It will also remove the burden of choice from family members who are grieving and possibly emotionally unable to make decisions.

It’s time to take responsibility for your end of life choice

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

Companies that provide selfless information through particip

. On my website, there is a FREE pdf of a Healthcare Directive (living will) that may be printed, signed, witnessed, and used to legally establish your desires regarding life-sustaining procedures and end of life decisions

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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