Advice You - Business

Flower Sour: Cupid, Chemicals, and Corporate Social Responsibility

A few days ago I had one of those “random” conversations that sets the brain blazing down a hundred differen

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

t paths almost immediately. The topic was DDT, and how that chemical was bought and sold with impunity in Latin America years after it had been banned in the United States for

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

Examples of combination products may in

causing serious health and environmental problems.

In the beginning it was the wonder chemical of yore. From getting rid of vermin, to use as an agricultural pesticide, to eli

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

minating malaria, the new potion apparently knew no bounds. Soon however, nasty little pieces of evidence – cancer, birth defects, and environmental hazards – started to spring

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

up against the wonder chemical. Consequently, during the 1970s and 1980s, agricultural use of DDT was banned in the US and most developed countries.

However, it would seem th

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

Combination pro

is urgent health and environmental update somehow bypassed Latin America and some other parts of the world. In countries like Ecuador and Colombia, DDT and similar derivatives

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

remain in active use especially for agricultural purposes. All this despite the 2001 Stockholm Convention calling for the elimination of such “persistent organic pollutants” in

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

agribusiness.

DDT and other such persistent pollutants are just that – persistent. In human and other animal life, they cluster in fatty areas and proceed, nonstop, to erode

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

the system from within. And this is just the proverbial tip.

Marketing and selling chemicals in developing countries, where public awareness of negative effects may be lower,

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

is irresponsible, to say the least. And obviously certain businesses thrive by courting governments that are either more susceptible to manipulation or prone to allowing the un

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

hecked commercialization of such hazardous products.

The ongoing side effects from the continued use of such chemicals in Colombian and Ecuadorian floral workers – headaches,

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

Following aspects would a

nausea, impaired vision, asthma, stillbirths, congenital malformations, miscarriages – are graphic and constant reminders of the blatant sociopolitical and economic double stan

dd to the challenges in developing combination products:

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

dards at play in our current global dynamic.

Sneaky history. It almost impressive the way it keeps recycling itself. Well, at least we can’t call it unsustainable.

Columbia i

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

s the second largest flower producer in the world. Two-thirds of all fresh cut flowers sold in the United States come from Columbia. Dole, the leading producer of fresh fruit a

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

nd vegetables, is also one of the largest flower producers in Latin America.

Dole’s official CSR report reads like a dream. That is, until you consider the fact that Columbian

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

and Ecuadorian floral workers, many of them women, are exposed daily, to some of the most toxic chemicals available. Or unavailable – about a fifth of these chemicals used in

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

Professional from academic institutions, pharmaceutical industries, health care indust

the greenhouses are either banned, or not registered for use in the US or Canada for various health reasons. Dole has agreed to participate in an environmental standards progra

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

m, but the question is whether the affected governments have any real monitoring systems in place.

The promotion of agribusiness should not come at the cost of human health, e

.

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

nvironment, or wildlife survival. This should be the business bottom line. However, looking at the plight of flower workers in Columbia and Ecuador, this common sense goal star

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

Companies that provide selfless information through particip

ts to look more like a foolish dream.

Is a rose just a rose anymore? I would argue with the bard. It would seem that its thorns are more the norm in certain parts of our world

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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