A major corporation identified an opportunity for business extension which with introduction of new products would enhance their already dominant position in the market. The future product was intended to inhibit an enzyme that results in release of an unpleasant odor from body waste. It would be necessary to create a product from scratch and a newly minted chemist was assigned the task. He made serious errors which were compounded by managements over enthusiastic involvement in the project.
As most products do, this one required a carrier not only to dilute the chemical to a level adequate for performance but constrained by economics. Being a budding environmentalist, our chemist sought out products that could best be described as "by-products" of other industries that were looking for a place to make these substances disappear. Considering what was available he decided that the preferred material would be of natural origin. He settled on something from the paper industry and it did have the property of being able to absorb the active chemical and release it on demand. However, he failed to submit the product to the "nose" test. Only after many weeks of formulation, did someone point out to him that the carrier stank. This should not have come as a surprise since anyone driving by a wood-pulp processing (paper) plant cannot escape the fact that there is always a bit of sulfurous waste in the air that may smell like money to some but to others is foul. At any rate, rather than going back to the drawing board, our chemist decided to mask the smell. Another disaster, the perfume he chose gave the product an acceptable and actually pleasant smell not unlike fresh mown hay. Alas, coumarin on which the odor mask was based is listed as a potential carcinogen. Finally, the decision was made to use a store-bought fragrance. Problem again, which didn't emerge until the final formulation went to the field for testing. Seems that when there was any moisture around, the unpleasant smell reemerged. But fortunately this problem disappeared as you shall soon see.
It was time for upper management to cast their lot and thus become a bit of the problem. As is the case in most major corporations, the chief operating officer, chief executive officer, president or some other high corporate person with a nice title is always looking for a bit of technology that can be used to dazzle the stock holders, writers of the market press, and perhaps the governmental agencies that seem to always be about, casting dispersions on profit-driven capitalist. The trickle of monthly reports is typically guarded over by a vice president of research or director or research who has the wisdom to screen from the upper echelons, those "facts" that are being developed in the laboratories. In this way, the feeding of those who really don't need to know, is regulated. Perhaps in a bit of over zealous self-serving or maybe because at a dog and pony show, it was suggested that maybe, just maybe, something in the lab might just be evolving that would have a major positive effect on the bottom line, the company's chief executive officer got wind of the project. He requested (which is to say, he demanded) that he be personally updated on the project at each and ever turn. In a company with tens of thousand employees, keeping an eye of a project and the efforts of a single research scientist, is certainly grossly inefficient. But because of his request, suddenly, the director of research, the site vice president, the manager of the laboratory, the regulatory affairs specialist, the liaison officer between in-house and off-campus research, the business planning vice-president and the business manager of the project, as well as the division vice president, the manager of the product line to which the new innovation was intended, the vice president of the organic chemical division, the research director of that division, the chief chemist responsible for pilot plant product development and others too numerous to mention were all of the sudden, made aware that they must keep on top of this project and accordingly, their monthly reports must carry statements, pert charts, analysis, &c., to show their involvement and how they were contributing to the success of this now certain mega-product that would shape the company's future.
Until all of the above became involved in the project, our "chemist" could do just about what he liked with little compunction to consider if and when his work would have an effect on the company. It never occurred to him that his rising star, in attracting so much attention, could have any adverse effects on his career. Suddenly, he was given a couple more technicians, expected to attend management meetings, make presentations, lead learned discussions on the economics of new product development, as well as travel extensively to be sure that he understood the "odor control" industry and the products that were available from the competition. His immediate supervisor now became a travel agent, spokesman for the scientist, marketing specialist, international visitor and on call to answer questions about the project and its future role in shaping the company.
With this background, it is not surprising that the pressure to produce, and produce on schedule, became the dominant force in the direction of research. A manager who couldn't sign a requisition for more than a thousand dollars without a co-signature, suddenly could engage the company in a contract for a quarter of a million dollars with a phone call. These were rich and heady times.
But what about the project and the product? With the advent of the computer, suddenly much painstaking literature research could be done from your very own desktop. One could scan the recent journal indexes, click on an order form and the new work would be delivered to your desk the next day or perhaps before. The librarians wanted a bit of the action and they ran literature reviews ad-nauseam. All this information was sent to our scientist who now too busy with more important issues, directed that his staff make him aware of the latest discoveries in the field and not bother him with the day to day research.
Not surprising, the neophytes discovered that there was an enormous literature out there that listed not one but many, many enzyme inhibitors, some of which affected the enzyme of interest and further that university researchers could be identified for expert knowledge of specific classes of compounds. It didn't take much to rank these compounds (and university hired guns) on a scale of say one to one-hundred, determine cost-effectiveness and arrive at a family of chemicals (and consultants) that would do exactly what was wanted. Our chemist's staff were elated, consultants hired and materials ordered. New compounds were proposed and synthesis began to generate a number of promising leads.
One particular class of compounds stood out and the pilot plant was activated to produce a "pseudo organic" that would be replaced with the real thing as soon as the most active inhibitor was identified. The patent attorney started his wheels grinding and carefully lead the research team to generate "facts on the ground" that would substantiate the effectiveness and uniqueness of this new breakthrough and assure that the patent office would grant an all inclusive patent.
Within a month, our organic chemist had decided based on the information at hand, that one particular compound would be "the" product. Now synthesis began in earnest, tweeking the reactants to increase yield, worrying about by-products and how to make them disappear, ordering larger and larger quantities of starting materials. Formulation studies found the best ratio of carrier to active ingredient based on cost and effectiveness.
The business planners solicited; advertising agencies, packaging companies for advanced information; enlisted consultants to help lead the product through the state and federal regulatory agencies; began the process of handing off the product from research to the marketing arm of the company and of course always, as did all the other participants, kept upper management informed on the progress of the project. In the mean time, marketing studies were commissioned, focus groups held, surveys sent to potential customers and a bit of information was leaked to understanding members of the press.
It seems almost as an afterthought that the candidate compound would be shuttled through toxicological test. The first were simple with a study to see if they had mutagenic effects on bacteria. No problem. Test going under the name, LD-50, which simply means; at what concentration will the product kill fifty percent of the animals if it is consumed, were of course run and data extrapolated to show that the material was safe when massive quantities were consumed, so not to worry.
Test-tube test of effectiveness were convincing. This product worked!
Now the pilot plant began to crank out real material first in grams, then in kilograms and finally in a display of true efficiency produced over a ton of material, right there on the research campus.
Of course the tox-experiments continued so that the boiler-plate for the Food and Drug Administration and any other agencies would be at hand and show convincingly the safety of the new product. One such experiment had to do with placing the material on the litter of cages in which rats were housed. This was a lot easier than painting the rats daily and certainly they would be intimate contact with the odor-inhibitor as though it had been placed under their arms or what ever. Here's where the wheels fell off.
In a routine visit to the contract research lab conducting the tox-experiments of which that described was just one of many, a project manager was told that there appeared to be something wrong. The rats weren't producing as many babies as would be expected. In fact, some of the females were aborting. (Now anyone familiar with rats, may know that rats consume their own if the offspring is born dead or defective.) So the first clue that something was wrong was that there just were not as many pups as would be expected.
Fortunately this flag was not ignored and the project manager ask for a review and in a matter of hours, evaluating the data and going into the facility and observing a group of females that were in the process of birthing answered the question. The pups were either being born dead or deformed, and there were fewer that normal at that which suggested that at least some were being reabsorbed in the uterus. A quick exsanguation of a couple of males so that their sperm could be examined showed that the sperm count was low and there were multiple abnormal sperm cells.
It didn't make much difference whether it was the male or female side of the family that was affected, or both, there was a major problem. The "Product" was in the field, being shipped all over the country by various carriers. Carefully designed experimental protocols were in place and real people could be exposed to the product. Certainly, laboratory workers and in particular pilot plant researchers could be endangered.
To the credit of the company within hours after the first clues to a problem emerged, a top to bottom and bottom to top alert was posted. Product was secured and everyone notified of a potential problem. A massive accounting of the material was underway and every gram of the compound was accounted for. The project was dead!
How could this have happened? It's really quite simple. Researchers depending on the information on their computer screens assumed the class of materials was safe. Had they gone to the older literature, that which was published prior to 1970, they would have found ample evidence of toxicity.
Well not all stories have such a bad ending, in fact this one doesn't as well. Seems our esteemed Doctor of Philosophy in Organic Chemistry, moved on to another company. At last sighting, he was Director of Research at a major bio-tech company. Hopefully, his education in studying the literature has rubbed off on his underlings and they are onto something that will benefit society without the risk of, say, a far from innocuous compound that almost made its way into the hands of consumers.
"Ignorance is Bliss."
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