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E-Folder - The Industrialized World Isn't Safe From Pandemic
The recent cover stories in USA Today, beautifully depict the potential spectrum of disease and the implications of human vulnerability to pandemic flu and specifically the H5N1 avian flu strain.
But the real threat lies not in the obscure genetics of a common virus or in the family
But the real threat lies not in the obscure genetics of a common virus or in the family
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
lineages of its victims. The true impact of this disease lies in the numbers. In 1918 100 percent of the entire world was exposed to what would later be called the Spanish Flu. This new strain of avian flu had never been encountered before by a human population, and as a result, th
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
re was no immunity to this particular strain. Of that world population, one third would ultimately fall ill, in fact, 50 to 80 percent of the youngest, healthiest, and strongest would fall ill when future generations would divide out the victims.
Of those that fell ill, half ultimat
Of those that fell ill, half ultimat
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ly required some assisted care. They were placed in infirmaries or makeshift hospitals in warehouses, wharfs, and military barracks. In today's world, they would qualify for hospital care or home health nursing.
Of those hospitals and infirmaries, half suffer extreme respiratory di
Of those hospitals and infirmaries, half suffer extreme respiratory di
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ficulties as their lungs filled with fluid and blood, the result of their own bodies' counterattack on the viral invasion. Coughing and frothing at the mouth, occasionally spitting up blood, these individuals would have a disease that today’s medical professionals call ARDS, Acute Re
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
piratory Distress Syndrome. In the modern medical age, these patients would have a plastic tube placed into their lungs to assist their breathing and a ventilator would force air in and out of their lungs. Half of the ARDS patients 1918 died.
But it's not percentages, but real numb
But it's not percentages, but real numb
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
rs that portend the severity of this disease. There are over 300 million people in the United States and over 6 billion worldwide.
One third of those will fall ill. One hundred million here at home and two billion across the planet.
Half of those individuals will qualify for hospi
One third of those will fall ill. One hundred million here at home and two billion across the planet.
Half of those individuals will qualify for hospi
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
alization. Unfortunately, in a survey performed by the American Hospital Association in 2005, there are only 955,768 hospital beds in the United States, far short of the 50 million that would be needed. To make this situation work, at the peak of cold and flu season in 2005, only fo
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
r percent of these hospital beds were available and unoccupied. That means that there will be fewer than 40,000 hospital beds available for this onslaught of 50 million patients.
Of the 50 million patients who qualify for hospitalization, half or more will need ventilators. Dr. Mic
Of the 50 million patients who qualify for hospitalization, half or more will need ventilators. Dr. Mic
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
ael Olsterholm in a New England Journal of Medicine article in 2004 found that there were only 105,000 ventilators in the United States. Of these, a high percentage were either already in use for chronic ventilator-dependent patients such as small children and spinal cord patients, o
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
were out of service for cleaning and repair, leaving just over 16,000 ventilators available nationwide to help 25 million flu related ARDS victims breathe.
Of the 25 million with ADRS, with or without ventilator care, half would be expected to die. This 12.5 million people will pas
Of the 25 million with ADRS, with or without ventilator care, half would be expected to die. This 12.5 million people will pas
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
away in waves as pandemic influenza spread over a span of only 12 to 18 months.
Now, admittedly, these are the most dire numbers. The pandemic flu could prove to be far less deadly, far less contagious. On the other hand, H5N1 has already proven to be a formidable foe with death r
Now, admittedly, these are the most dire numbers. The pandemic flu could prove to be far less deadly, far less contagious. On the other hand, H5N1 has already proven to be a formidable foe with death r
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
tes initially greater than 70 percent and now still hovering around 50 percent.
The Centers for Disease Control (CDC) have given optimistic sounding percentages but as the old adage goes, the "devil is in the details". Let's look at the percentages and the details.
* One
The Centers for Disease Control (CDC) have given optimistic sounding percentages but as the old adage goes, the "devil is in the details". Let's look at the percentages and the details.
* One
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
third of 100 percent is 33 percent.
* This is the “attack rate”.
* Half of 33 percent is 16.5 percent.
* This is the number of people who qualify for hospitalization, but the CDC knows that in the event of a pandemic, only the most sick will actually be placed in t
* This is the “attack rate”.
* Half of 33 percent is 16.5 percent.
* This is the number of people who qualify for hospitalization, but the CDC knows that in the event of a pandemic, only the most sick will actually be placed in t
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
e hospital. Clearly the most sick will be those with ARDS.
* Half of 16.5 percent is 8.25 percent.
* These are the sickest of the sick, those with ARDS. Rounded off, this is 8 percent, the number that the CDC says to expect for hospitalization.
* Half of 8 percent
* Half of 16.5 percent is 8.25 percent.
* These are the sickest of the sick, those with ARDS. Rounded off, this is 8 percent, the number that the CDC says to expect for hospitalization.
* Half of 8 percent
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
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
s 4 percent.
* This is the expected death rate predicted by the CDC.
The “devil in the details” is that these percentages are based on "the total population." Physicians, medical planners, and other pundits usually discuss percentages based on "those with the fl
* This is the expected death rate predicted by the CDC.
The “devil in the details” is that these percentages are based on "the total population." Physicians, medical planners, and other pundits usually discuss percentages based on "those with the fl
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
". We are not talking about “those with the flu” we are talking about a number three times that size.
USA Today showed us how two third world countries are struggling and in some cases failing to deal with the crushing weight of a comparatively small outbreak of avian flu (H5N1). In
USA Today showed us how two third world countries are struggling and in some cases failing to deal with the crushing weight of a comparatively small outbreak of avian flu (H5N1). In
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
Indonesia, the efforts are crippled at best. In Vietnam, the efforts are being met with greater success, but the disease rages on. The industrialized world relies on the fact that its health care is unmatched. The United States likes to believe that US health care exceeds all other
.
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
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
The numbers show that when this disease strikes the whole world is at peril.
What are the answers? As with any impending disaster, the answers lie in preparation, planning, and practice; Repeated, Relentless, and Rigorous practice. It is the responsibility not just of government
What are the answers? As with any impending disaster, the answers lie in preparation, planning, and practice; Repeated, Relentless, and Rigorous practice. It is the responsibility not just of government
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
but of private health care institutions, hospitals, health care professionals, businesses, corporations, and yes, even individuals, to prepare now for the worst while hoping for a reprieve. We can no longer afford to prepare for the best and then stand awestruck when the worst occurs
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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