As an equal opportunity alarmist, I will now address the counterfeiting issues faced by Eli Lily’s Cialis. The “Help Wanted” character included with this post is an apt metaphor for what Cialis provides for many men and their partners. The romantic couple in the dual bathtubs overlooking the picturesque valley would encounter a crescendo of disillusionment and disappointment if “Big C” failed to activate. It’s hard work dragging those old cast iron bathtubs up a slope so that two giddy people can enjoy the panorama and…the anticipation.
The payoff would be nil if the counterfeiters, diluters/adulterators are successful. The title of this post suggests (Yes, yes) a successful outcome, but if those who mess with legitimate pharmaceuticals are able to integrate their bogus products into the supply chain, then the response may become “No, No Cialis.” The happy couple would be overwhelmed with disappointment, perhaps believing that Cialis would not work for them. They might abandon their quest for hilltop intimacy and convert the old tubs into flower boxes. Perhaps in the distant recesses of their minds, they may silently question the credibility of the Eli Lily company. It is conceivable that out of frustration or embarrassment that they do not seek answers as to why the product failed to deliver but merely accept their cruel fates with a repressed whimper.
This story could end somewhat differently if we were discussing heart medicine, high blood pressure medicine or any number of pharmaceutical wonders that prolong or improve our lives. Counterfeit or adulterated medications may not lead to just frustration but perhaps to a fatality. Fake pharmaceuticals could result in an unnecessary continuation of symptoms and painful, prolonged care. The healing process has a mental or psychological component that could be drastically eroded by ineffective or harmful counterfeits.
So, who pays for junk that gets inserted into the pharma supply chain? The guy in the bathtub is out $50-60 for the package when he fails to get lift off. The coronary patient may pay with her life. The dermatology patient may suffer several additional weeks of itching , rashes and sleepless night. Clearly, the manufacturers and patent holders lose sales…and reputations. And so do distributors. Providers may experience an erosion of confidence as their patients question their knowledge. In sum, everyone loses. So, let’s say “Si’, Si’” to safeguarding the safety of the product, jump into our bathtubs and enjoy the vista of a safer tomorrow.
Friday, February 27, 2009
Thursday, February 26, 2009
Good, Bad and Ugly
A recent article on this site described the attempts by the World Health Organization (WHO) to define “counterfeit” pharmaceuticals. The solution to this quandary seems rather obvious to me. Let’s start with the assumption that only flawed pharmas require definition. The “good’ ones are those that maintain compound and quality integrity and function as they were intended to do. The “bad,” on the other hand, are those that either fail to perform or cause harm because their compounds or quality were inadvertently compromised. Finally, the “ugly” are those counterfeits or adulterations that were intentionally created to cause harm to reap unwarranted profits.
So, the essence of the definitions goes to whether or not the faulty pharmaceutical was the result of intentional or unintentional action. These definitions follow the same distinctions as one would encounter when deciding between first degree murder or negligent homicide as descriptions of culpability. One is a result of malice and forethought while the other comes about because of a lack of diligence, human error or equipment malfunction. The definition of the product falls to the intention of the manufacturer or party who alters the product. Clearly, intention should be determined through the judicial process, and the appropriate remedies should be levied at sentencing.
The bottom line, however, is not the intention behind the flawed product, but rather, the detection and elimination of the “bad” and the “ugly” from the supply chain. Policing agencies and courts can deal with the apprehension and adjudication of the actors who traffic the “bad” and the “ugly.” The industry’s role is to insure that counterfeits and adulterated pharmaceuticals are detected and intercepted prior to their arriving near providers and patients. Bad and Ugly will always be around, but if members of the supply chain commit to protecting the Good from the debilitating effects of the Bad and Ugly, then the entire industry, throughout the supply chain, will prosper.
It has often been said that “the perfect shouldn’t be the enemy of the good.” That statement may have some valiance in politics, football and polka dancing, but it could be catastrophic in pharmaceuticals and health care. The good isn’t good enough. Mere perfection is the only standard.
So, the essence of the definitions goes to whether or not the faulty pharmaceutical was the result of intentional or unintentional action. These definitions follow the same distinctions as one would encounter when deciding between first degree murder or negligent homicide as descriptions of culpability. One is a result of malice and forethought while the other comes about because of a lack of diligence, human error or equipment malfunction. The definition of the product falls to the intention of the manufacturer or party who alters the product. Clearly, intention should be determined through the judicial process, and the appropriate remedies should be levied at sentencing.
The bottom line, however, is not the intention behind the flawed product, but rather, the detection and elimination of the “bad” and the “ugly” from the supply chain. Policing agencies and courts can deal with the apprehension and adjudication of the actors who traffic the “bad” and the “ugly.” The industry’s role is to insure that counterfeits and adulterated pharmaceuticals are detected and intercepted prior to their arriving near providers and patients. Bad and Ugly will always be around, but if members of the supply chain commit to protecting the Good from the debilitating effects of the Bad and Ugly, then the entire industry, throughout the supply chain, will prosper.
It has often been said that “the perfect shouldn’t be the enemy of the good.” That statement may have some valiance in politics, football and polka dancing, but it could be catastrophic in pharmaceuticals and health care. The good isn’t good enough. Mere perfection is the only standard.
Wednesday, February 25, 2009
Ahead of the Curve
The major portion of our discussions on these pages has focused on the impact of counterfeiting and adulteration on patient safety and supply chain reliability. This is where the primary consideration should be, but there are other important factors in play, too. Much of the recent news coverage has chronicled the challenges facing the national …and global economies. Corporations and businesses everywhere are belt-tightening, downsizing or closing. Some businesses will thrive in this environment by becoming leaner and more efficient while others will enter “panic mode” and never fully recover from these trying times.
From my experience as a business manager and as a corporate and business trainer, I have had the opportunity to witness how truly successful leaders cope with difficult circumstances. Although the “right now” requires intensely concentrated effort and resources, successful leaders never fail to look ahead to tomorrow. They do not abdicate their duties for visionary thinking and acting. They race ahead of the curve.
It is difficult for a corporate officer or manager to justify purchasing new technology when the market is uncharacteristically tough. Concentration is directed to monthly P&L’s, quarterly statements, and annual reports. Every nickel that can be saved and every penny pinched become important for day-to-day operations. “No major expenditures” and “no new commitments” become the rallying cries for weathering the economic storm. Count the pens! Inventory the paper clips! Use both sides of the printer paper! I could go on, but you get the idea.
While the market, the governments, customers and patients are clamoring for safer and more reliable pharmaceutical delivery, you cannot afford to retreat into a posture of preservation. You, as a leader, who wants to guide a leading company of the industry must seize the initiative. The old reliable aphorism “if you’re not moving forward, then you’re falling backward” is still true. Offer more for your customers—better service and safer product.
Imagine this scenario: A customer calls your office and asks you to submit an RFP. This company is impressed with your innovative efforts to supply safe, trustworthy products as well as your obvious commitment to top-rate customer service. Another customer calls your competitor, and the receptionist responds,” I’m sorry, he can’t come to the phone right now. He’s in the supply closet counting paperclips.”
From my experience as a business manager and as a corporate and business trainer, I have had the opportunity to witness how truly successful leaders cope with difficult circumstances. Although the “right now” requires intensely concentrated effort and resources, successful leaders never fail to look ahead to tomorrow. They do not abdicate their duties for visionary thinking and acting. They race ahead of the curve.
It is difficult for a corporate officer or manager to justify purchasing new technology when the market is uncharacteristically tough. Concentration is directed to monthly P&L’s, quarterly statements, and annual reports. Every nickel that can be saved and every penny pinched become important for day-to-day operations. “No major expenditures” and “no new commitments” become the rallying cries for weathering the economic storm. Count the pens! Inventory the paper clips! Use both sides of the printer paper! I could go on, but you get the idea.
While the market, the governments, customers and patients are clamoring for safer and more reliable pharmaceutical delivery, you cannot afford to retreat into a posture of preservation. You, as a leader, who wants to guide a leading company of the industry must seize the initiative. The old reliable aphorism “if you’re not moving forward, then you’re falling backward” is still true. Offer more for your customers—better service and safer product.
Imagine this scenario: A customer calls your office and asks you to submit an RFP. This company is impressed with your innovative efforts to supply safe, trustworthy products as well as your obvious commitment to top-rate customer service. Another customer calls your competitor, and the receptionist responds,” I’m sorry, he can’t come to the phone right now. He’s in the supply closet counting paperclips.”
Background and Justification II
The personal history that I have recounted in Background and Justification, Part I, is the primary reason for this blog's existence. As a student and practioner of politics, business and communication, I am a voracious reader. As a result, I have an opinion about nearly everything. I do value consistency and reason so I am continually challenging myself by measuring my beliefs against the facts as I know them. Most of us build our belief systems by accumulating a series of anecdotal data and connecting the dots...or filling in the gaps. I try to go beyond that by aggressively seeking confirming or contradictory information. Nevertheless, my knowledge and understanding are not flawless.
If I were asked to define my world view, it would be that I see myself as a libertarian, conservative, objectivist and constitutionalist christian. Figure that out if you can...I'm still working on it. For the moment I live in Illinois although I'm preparing for a move back to Ohio where I was born and reared. From time to time I consider aquiring 40 acres in Idaho and moving off the grid. I probably never will, but I fear for the direction our country and our society has taken. It's not lifestyles or even political preferences that have made me uneasy. Rather, I have become alarmed by values (not in the traditional sense), that is I am quite discomfited by what we value in this era. We seem to be obsessed with frivolity and meaninglessness. We relish the role of victim and demand nearly every creature comfort of modern-day living as a right.
If I were asked to define my world view, it would be that I see myself as a libertarian, conservative, objectivist and constitutionalist christian. Figure that out if you can...I'm still working on it. For the moment I live in Illinois although I'm preparing for a move back to Ohio where I was born and reared. From time to time I consider aquiring 40 acres in Idaho and moving off the grid. I probably never will, but I fear for the direction our country and our society has taken. It's not lifestyles or even political preferences that have made me uneasy. Rather, I have become alarmed by values (not in the traditional sense), that is I am quite discomfited by what we value in this era. We seem to be obsessed with frivolity and meaninglessness. We relish the role of victim and demand nearly every creature comfort of modern-day living as a right.
Pfizer Pfakes:broken hearted old men.
A recent news item on this web site chronicled the massive distribution of counterfeit Pfizer products in the Mid-East. Actually, the problem is a more global one. Fake pharmaceuticals do not respect boundaries or jurisdictions. Fake drugs and their purveyors do not respect people, either. They insidiously penetrate every market, every demographic, everywhere. Various articles and research papers have identified the real harm done to patients by the nefarious substitution or adulteration of pharmaceuticals.There is another massive downside to the “faking” industry that is rarely discussed. As a person who has sailed past my sixtieth (60th) birthday in recent years, I play golf, enjoy social activities and have clients who are in their “golden years.” The nest is empty, and perhaps, retirement goals have been achieved. A lifetime of stress and hard work has taken its toll on the body and the mind. As the person begins his glide pattern in life, he discovers that he has heightened energy and new purposes in life. But alas, the body that has been broken and abused for many years will not cooperate. But wait! Viola’ (maybe I should say “Viva”). What once was but a distant dream has now become quite feasible.The potential for rekindling the romantic lives of these aging warriors has filled them with hope and optimism. Their significant others, while perhaps skeptical in the beginning, may share in their mates’ revivals with gusto and gladness. Then Whammo! Nothing happens. The dreams of reinvigorated lives together become downcast and droopy. The hope for shared love does not spring. The promises of new beginnings fade into distant memories of days gone by.There are a multitude of snide jokes about the users of Viagra. There is, however, a real cost when the product is counterfeit. It is more than some randy old guy trying to get his jollies at the local bowling alley or cocktail bar. Real people, real couples, real frustration and disappointment color the landscape of people who had hoped to recapture the spark. Maybe they will grasp the hope anyway despite the failure of the drug, but the detour and the delay are unnecessary and avoidable.
Saturday, February 21, 2009
Where vs. What
By Charles R. Earl M.A., ABD
CEO, Communication Connections
During my misspent youth, I enjoyed a comic strip called “Spy versus Spy.” Well, this column has nothing to do with that classic confrontation between good and evil. This blog is dedicated to a common-sense comparison of two primary drug safety technologies. The Where versus the What. I have been tangentially involved with the pharmaceutical industry for nearly a quarter century and vividly remember the valiant efforts to get manufacturers to accept RFID as a viable method for enhancing supply-chain safety. Many have embraced the concept, and there is no doubt that providers and patients have reaped huge benefits as a result of the industry’s efforts to enhance safety and reliability.
RFID is a valuable asset in the trend toward better, safer and more effective products for pharmaceutical consumers. The buggy was a vital component of our ancestors’ lives. It allowed for easier movement of goods and families than was available by horseback or walking. In fact, a carriage ride through Central Park is a pleasant (and perhaps romantic) diversion from the hustle-bustle routine of our daily lives. But when it’s time for serious endeavors, we rely on the automobile or the truck. The buggy still works and has some intrinsic value, but when the rubber meets the road, the automobile is critical.
The Where is the primary focus of RFID. Where has the product been (Remember when Mother used to say, “Don’t put that in your mouth. You don’t know where it’s been?”). So, now we know where it’s been, but are we confident that we know what it is? Even when we are absolutely, unequivocally, slam-dunk certain where it’s been, are we willing to put it in our mouths? Do we know what it is?
“Where- versus- What” does not necessarily require that we drown in a pool of angst. Both are important . Knowing the Where is important for underscoring confidence and aiding law enforcement. Knowing the What is vital. People’s and pets’ lives are at stake. RFID is invaluable for integrity in the supply chain. EDXRD is critical for confirming that the product requested is the product received.
Now, let’s change the formula suggested by the title of this column. Where is good. What is good. Where+What versus the bad spy.
By Charles R. Earl M.A., ABD
CEO, Communication Connections
During my misspent youth, I enjoyed a comic strip called “Spy versus Spy.” Well, this column has nothing to do with that classic confrontation between good and evil. This blog is dedicated to a common-sense comparison of two primary drug safety technologies. The Where versus the What. I have been tangentially involved with the pharmaceutical industry for nearly a quarter century and vividly remember the valiant efforts to get manufacturers to accept RFID as a viable method for enhancing supply-chain safety. Many have embraced the concept, and there is no doubt that providers and patients have reaped huge benefits as a result of the industry’s efforts to enhance safety and reliability.
RFID is a valuable asset in the trend toward better, safer and more effective products for pharmaceutical consumers. The buggy was a vital component of our ancestors’ lives. It allowed for easier movement of goods and families than was available by horseback or walking. In fact, a carriage ride through Central Park is a pleasant (and perhaps romantic) diversion from the hustle-bustle routine of our daily lives. But when it’s time for serious endeavors, we rely on the automobile or the truck. The buggy still works and has some intrinsic value, but when the rubber meets the road, the automobile is critical.
The Where is the primary focus of RFID. Where has the product been (Remember when Mother used to say, “Don’t put that in your mouth. You don’t know where it’s been?”). So, now we know where it’s been, but are we confident that we know what it is? Even when we are absolutely, unequivocally, slam-dunk certain where it’s been, are we willing to put it in our mouths? Do we know what it is?
“Where- versus- What” does not necessarily require that we drown in a pool of angst. Both are important . Knowing the Where is important for underscoring confidence and aiding law enforcement. Knowing the What is vital. People’s and pets’ lives are at stake. RFID is invaluable for integrity in the supply chain. EDXRD is critical for confirming that the product requested is the product received.
Now, let’s change the formula suggested by the title of this column. Where is good. What is good. Where+What versus the bad spy.
Tweet, Tweet, Tweet
Charles R. Earl, MA, ABDCEO, Communication Connections
Back in the day, deep-shaft miners would lug a caged canary with them to serve as an early warning system if the oxygen supply should fail. If the canary would croak, then miners would hustle out of the hole. Recent events and diligent studies have demonstrated that the “drug safety canary” is developing a weakening “tweet.” The canary is not yet dead, but she is on serious life support.Remember the concerns surrounding the adulterated heparin last year? My son was in intensive care with heparin as a vital component of his treatment at the very time when instances of the degraded drug were making headlines. An extremely stressful situation was dramatically compounded by the knowledge that a critical element of his care might be compromised. So I, man-on-the-street Charlie Earl, was smacked upside the head by the potential danger of an unsafe pharmaceutical. I was not the one being administered the drug. My son was, but my confidence in the safety of the system and the supply chain was shaken. I wondered “how is it possible for an adulterated product to get to the patient’s beside without having been detected?”In a January 4th, 2009 article in the UK Guardian, Mark Townsend describes British authorities’ efforts to stem the flood of fake drugs into Britain. He quoted an Interpol official who admitted “to being ‘shocked’ at discovering that fake drugs were more deadly than terrorism.” Even if the representative of the international police agency were exaggerating, the issue of drug counterfeiting is, nonetheless, an enormous and growing problem. Our national level of awareness regarding drug safety is similar to our concerns about identify theft a decade ago. We are aware that a problem exists but believe it to be too small for swift and resolute action. When, however, we become personally affected by the problem (e.g. unwarranted charges on the credit card…or a seriously ill son attached to a multiplicity of machines in a cold and sterile hospital), then our senses are jolted, and we begin to repair our vulnerabilities. Let’s just hope we are not too late.
Posted by xstream team at 1:36 PM
Labels: patient safety, pharamaceutical security
Charles R. Earl, MA, ABDCEO, Communication Connections
Back in the day, deep-shaft miners would lug a caged canary with them to serve as an early warning system if the oxygen supply should fail. If the canary would croak, then miners would hustle out of the hole. Recent events and diligent studies have demonstrated that the “drug safety canary” is developing a weakening “tweet.” The canary is not yet dead, but she is on serious life support.Remember the concerns surrounding the adulterated heparin last year? My son was in intensive care with heparin as a vital component of his treatment at the very time when instances of the degraded drug were making headlines. An extremely stressful situation was dramatically compounded by the knowledge that a critical element of his care might be compromised. So I, man-on-the-street Charlie Earl, was smacked upside the head by the potential danger of an unsafe pharmaceutical. I was not the one being administered the drug. My son was, but my confidence in the safety of the system and the supply chain was shaken. I wondered “how is it possible for an adulterated product to get to the patient’s beside without having been detected?”In a January 4th, 2009 article in the UK Guardian, Mark Townsend describes British authorities’ efforts to stem the flood of fake drugs into Britain. He quoted an Interpol official who admitted “to being ‘shocked’ at discovering that fake drugs were more deadly than terrorism.” Even if the representative of the international police agency were exaggerating, the issue of drug counterfeiting is, nonetheless, an enormous and growing problem. Our national level of awareness regarding drug safety is similar to our concerns about identify theft a decade ago. We are aware that a problem exists but believe it to be too small for swift and resolute action. When, however, we become personally affected by the problem (e.g. unwarranted charges on the credit card…or a seriously ill son attached to a multiplicity of machines in a cold and sterile hospital), then our senses are jolted, and we begin to repair our vulnerabilities. Let’s just hope we are not too late.
Posted by xstream team at 1:36 PM
Labels: patient safety, pharamaceutical security
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