Counterfeit Pharmaceuticals: The Public and Private Risk


Posted on 15 January 2002

Boston, MA - January 15, 2002

For many reasons Americans are going online to purchase medicine. Consumers are replacing a trip to the local drug store with surfing to e-pharmacies for their needs. Web sites are able to offer convenience, privacy unlike the local pharmacy and enable consumers to comparison shop. The vast number of these sites also provides unparalleled variety, availability and information for people looking to research new or different treatments. These reasons have led Forrester Research to project that in 2004 online prescription sales will account for 9.2% of a market surpassing $385 billion in 2001.i

There is a downside to online pharmacies, those who would exploit the idea of online drug distribution for personal gain. "The development of the Internet has opened up many new options for consumers to purchase products more conveniently," said Jane Henney, MD, Commissioner of U.S. Food and Drug Administration (FDA). "However, the Internet has also provided unscrupulous individuals with immense new opportunities to promote and sell [unlawful medications] to unsuspecting patients."ii

The Public and Private Risk

These 21st Century criminals have found their way into legitimate markets through the Internet. Their activities threaten the lives of everyday people and prey on the vulnerable. For example, a man buys Viagra from an online drug peddler, then abruptly dies during sex. An autopsy reveals that he had a heart condition and should never have been allowed to use the medication. The risk to public health is clearly the greatest concern with the distribution of counterfeit, misused and substandard drugs.

In mid-May, investigators from Columbia's National Institute for the Supervision of Medications and Food discovered a thriving drug business in Bogot�. It was not a cocaine or heroin factory, instead it was producing the flu drug Dristan and Ponstan 500, a painkiller made by Pfizer. The Columbian official in charge of the investigation said the pills contained boric acid, cement, floor wax, talcum powder and yellow paint with high levels of lead, all in an effort to replicate the drugs genuine appearance. These pills, like the Viagra could have taken the lives of people using the counterfeit medicine for their health.iii

The threat is not only to the general public. In cases like these personal injury lawyers will be out on the prowl. Knowing it is not worth suing the counterfeiter or e-drug merchant based in the Third World they go after the deep-pocketed manufacturers of the genuine medication. They argue the companies' liability stems from not keeping the counterfeit pill from being sold through suspect channels.

In today's mass media society, the threat to major drug manufacturers is not only the million dollar liability settlements, but also the threat to the companies' and the products' billion-dollar brand equity. News coverage of contaminated, counterfeit, mislabeled and misused medication undermines public trust and brand image. Pharmaceutical brand values are based on individual's belief that medications will help those in need, not hurt them. In 2001, the Pfizer Inc. brand name was valued at nearly $9 billion.iv

Counterfeited, misused and substandard products also affect other companies within a given value chain and threaten to undermine pharmaceutical manufacturers' business relationships. Partners and consumers have an expectation that manufacturers will proactively maintain the integrity of their value chain. If they don't, they expose themselves and others to civil liability and threats to their brand equity.

Securing the Value Chain

With the number of consumers buying prescriptions and non-prescription medications online increasing, the cost of pharmaceuticals rapidly rising and the sophistication of counterfeit production and distribution networks growing to encompass the whole world, the threat to consumers and companies is mounting. There are Third World drug rings finding counterfeit medications more profitable than street drugs and thousands of web pages and other forms of entry into the legitimate pharmaceutical market. To overcome the challenges set forth by the new world of the Internet and globalization companies must obtain the technology and strategy to counteract these 21st Century criminals.

Given the scope of the problem, affecting both the real world and the Internet, the solution becomes two fold. Rather than focus on one world at a time, the most efficient strategy is to attack the problem on two fronts. First, companies must proactively protect their products throughout their value chain to mitigate the risk from counterfeit products. Second, companies must use next generation technology to continually monitor the Internet for suspect pharmacies selling unauthorized products and other threats to public safety.

Over the last two years numerous government and professional agencies have made great strides to help combat this threat. The American Medical Association (AMA) has urged state medical boards, government regulators, and licensing agencies to investigate doctors who prescribe medications to patients who they have not examined. The AMA has taken the position that prescribing medications without patient consultation is unethical, but not illegal. The National Association of Boards of Pharmacy (NABP), which represents state pharmaceutical licensing authorities, has taken the position that any site that uses a questionnaire without a legitimate patient relationship is illegal. And last year the U.S. FDA devoted over 10,000 staff-hours per month to investigate Internet sites for online distribution of counterfeit pharmaceuticals.v

During that same period private companies have developed new technologies and tactics to combat this global problem. The technology and experience available at GenuOne can attack the problem along the two front strategy. Such an approach is by far the most efficient and effective way to cover both the physical and the Internet. GenuOne employs both automated Internet crawling and patent pending authentication technology to hunt down illicit Web sites and client dedicated analysts to integrate GenuOne's products into existing corporate technology.

An example illustrates GenuOne's comprehensive approach to securing the value chain. Recently, a large multinational pharmaceutical company, with revenue near $1 billion approached GenuOne about counterfeiting and diversion issues. In the last few years their business has spread around the world and due to currency fluctuations 3rd party product diversion has become profitable. The company envisions that counterfeiting is not far behind. The company also does not sell their products online, but they have noticed their products on e-pharmacies.

Conclusion

Identifying and disabling counterfeiting networks around the world is a daunting task, demonstrated by the amount of public and private agencies and level of effort currently employed by the task. Pharmaceutical companies are exposing themselves, the public and their brand integrity to significant risks. If the worldwide counterfeiting, misuse and substandard issue is not addressed with the full resources of private companies, government and private agencies then the threat to public safety will become epidemic.

About GenuOne
GenuOne systems enable companies to secure their value chain from counterfeiting, product diversion and intellectual property theft in the physical world and on the Internet. GenuOne's portfolio of technologies for comprehensive authentication and tracking of products helps GenuOne's clients minimize price, channel and brand erosion, customer dissatisfaction, and loss in shareholder value. For more information, please visit www.genuone.com.

i) Enos, Lori, U.S. States Target Illegal Online Pharmacies, E-Commerce Times, March 31, 2000
ii) "Regulating Online Pharmacies: Can the Industry Police Itself?"
http://www.MdNetGuide.com/articles.shtml?issue=25&dept=1
iii) Capell, Kerry, "What's in That Pill?" BusinessWeek Online, June 18, 2001.
iv) http://www.brandchannel.com/images/home/ranking_methodology.pdf, January 2, 2002.
v) Wedell, Kristin, "Cyberpatients and Online Prescription Sales"; The Internet Law Journal, November 15, 1999.

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