American Journal of Law & Medicine

Searching for safety: addressing search engine, website, and provider accountability for illicit online drug sales.

ABSTRACT

Online sales of pharmaceuticals are a rapidly growing phenomenon. Yet despite the dangers of purchasing drugs over the Internet, sales continue to escalate. These dangers include patient harm from fake or tainted drugs, lack of clinical oversight, and financial loss. Patients, and in particular vulnerable groups such as seniors and minorities, purchase drugs online either naively or because they lack the ability to access medications from other sources due to price considerations. Unfortunately, high risk online drug sources dominate the Internet, and virtually no accountability exists to ensure safety of purchased products. Importantly, search engines such as Google, Yahoo, and MSN, although purportedly requiring "verification" of Internet drug sellers using PharmacyChecker.com requirements, actually allow and profit from illicit drug sales from unverified websites. These search engines are not held accountable for facilitating clearly illegal activities. Both website drug seller anonymity and unethical physicians approving or writing prescriptions without seeing the patient contribute to rampant illegal online drug sales. Efforts in this country and around the worm to stem the tide of these sales have had extremely limited effectiveness. Unfortunately, current congressional proposals are fractionated and do not address the key issues of demand by vulnerable patient populations, search engine accountability, and the ease with which financial transactions can be consummated to promote illegal online sales. To deal with the social scourge of illicit online drug sales, this article proposes a comprehensive statutory solution that creates a no-cost/low-cost national Drug Access Program to break the chain of demand from vulnerable patient populations and illicit online sellers, makes all Internet drug sales illegal unless the Internet pharmacy is licensed through a national Internet pharmacy licensing program, prohibits financial transactions for illegal online drug sales, and establishes criminal penalties for all parties--including websites, search engines, and health care providers--who engage in and facilitate this harmful activity.

I. INTRODUCTION

The Internet is perhaps the most widely utilized technological innovation in the past twenty years. U.S. Census Bureau data from 2006 shows that over 200 million adults access the Internet. (1)

Tremendous benefits have resulted from the explosion of business and trade that has accompanied the Internet. By greasing the wheels of commerce, the Internet has provided significant reductions in cost and greater access to more products for more people around the world. Indeed, globalization of commerce is part and parcel of Internet transactions.

However, with such an increase in online sellers and willing buyers, the darker side of Internet sales has emerged. One area is particularly worrisome: the sale of medications over the Internet. Unscrupulous and nefarious individuals have entered this market, eager to sell tainted, fake, and poor quality drugs to anyone with a credit card and the willingness to pay. These sales are often not only an illicit means of profit but are also a foundation for additional criminal activity. (2) Physician oversight of care is left behind, and those who purchase these drugs take the risk that they will not get anything that they purchase, or worse, that they will get tainted medicines that do not effectively treat their disease(s) or may even harm or kill them. (3)

With unfettered Internet drug sales threatening public health, policymakers must be informed about this issue so that they can take the necessary steps to address the problem and allow the benefits of Internet purchasing to inure to patients. (4)

In Part II, we review the problem of online drug sales. The scope of Internet drug sales is burgeoning, and the dangers from these purchases are numerous, particularly for vulnerable patient populations. Despite warnings from government, law enforcement, and public health organizations, patients continue to purchase from suspect online sellers either because of lack of education or because in-person access to drugs presents challenges. Unfortunately, the Internet drug sales world is populated by unethical sellers and questionable providers that allow virtually any drug to be purchased with impunity.

In Part III, we discuss the lack of accountability and oversight of Internet search engines. Profits from advertisements incentivize search engines to maximize their numbers of online advertisers. Although Internet search engines purportedly "verify" the legitimacy of Internet drug sellers through PharmacyChecker.com, in fact, little verification of the potential advertisers actually takes place. "Verified" pharmacies sell fake drugs and do not fulfill the supposed verification "requirements." Both the pharmacy and the Internet search engine profit from the advertisements of non-verified pharmacies.

Part IV documents U.S. and worldwide attempts to limit the illicit use of the Internet for illegal drug sales and the ineffectiveness of these efforts. Regulatory efforts by organizations including the World Health Organization ("WHO"), domestic oversight agencies, and law enforcement have been hampered by a lack of regulatory infrastructure and enforcement power.

In Part V, we outline congressional proposals to address the problem of illicit online drug sales. Unfortunately, these proposals are fractionated and none comprehensively address the problem or the issue of search engine accountability.

In Part VI, we propose a federal bill that would address the key issues of illicit demand by vulnerable patient populations by creating a national no-cost/low-cost Drug Access Program to provide these groups with access to drugs without the need to use questionable online sources. In addition, the bill would create search engine accountability for facilitating illegal online sales by prohibiting any receipt of financial transaction proceeds for unlawful Internet pharmacy drug requests. The bill would establish a national licensing system that only allows legitimate Internet pharmacies to sell drugs online. Finally, and perhaps most importantly, the bill would create criminal offenses and strong penalties for all parties who participate in facilitating and engaging in the dangerous activity of illegally selling drugs online, including websites, search engines, and health care providers.

Part VII of the paper offers some concluding remarks. We call for a much more aggressive focus on Internet online drug sales, and for policymakers to ensure that systems be created to ensure no person need ever bet their lives or their families' lives on the safety of an online drug.

II. ONLINE DRUG SALES

A. SCOPE OF ONLINE DRUG SALES

The business of selling prescription pharmaceuticals over the Internet has fueled an industry that analysts estimate generated from $15-20 billion in sales in 2004. (5) Yet the illicit nature of online drug sales is apparent. For example, a detailed study of online drug sellers indicated that fully eighty five percent of websites offering drugs for sale required no prescription from a patient's physician. (6) To make matters worse, of the fifteen percent of sites offering drugs online that "require" a prescription, only half ask that the prescription be faxed, introducing tremendous opportunities for fraud and circumvention of legitimate and important physician oversight. (7)

The exact number of Internet drug sale sites (8) on the web is difficult to determine accurately due to the fact that illegitimate or "rogue" Internet drug sellers, which open and close with high frequency, often have several URLs for one company, and may only be transiently listed on select search engines. (9) As a reflection of this reality, a simple Google search at any given time using "Internet pharmacy" as the search term will reveal millions of results. (10) As might be expected, government officials trying to regulate these online sellers have had little success due to the sheer volume of sellers. (11)

These Internet drug sellers are of great concern with respect to consumer safety. Many are of international origin, advertise purchasing drugs without a prescription, and purport to have been approved by U.S. federal agencies such as the Food and Drug Administration ("FDA"). (12) These Internet drug sellers represent the highest risk category for consumers given the inability of U.S. regulators to ensure quality and safety. (13) As noted by Joseph Califano, Jr., director of the National Center on Addiction and Substance Abuse, "anyone of any age can obtain dangerous and addictive prescription drugs with the click of a mouse" (14)

B. DANGERS OF ONLINE DRUG SALES

The dangers these websites pose are numerous and rather self-evident. All implicate consumer safety as well as financial security. (15) These dangers include: the delivery of drugs or active pharmaceutical ingredients without a valid prescription; lack of professional oversight; the risk of questionable quality, counterfeit or substandard product; poor or lack of medication instructions; failure to provide adequate independent information to patients on possible adverse reaction and drug interactions; fraud; inability for consumers to be reimbursed by health insurance programs; and lack of confidentiality of personal medical data. (16)

Importantly, the uninsured and underinsured populations represent a significant at-risk group purchasing from these sites. These patients do not have access to or often cannot afford to see a physician and may instead elect to purchase drugs and seek treatment online. (17)

Also, spam e-mail and other electronic solicitations are something every e-mail user is familiar with and have the potential to entice individuals who may not have had the original intention of purchasing online,is Large scale criminal operations may be behind spam e-mails that promote the illegal sales of counterfeit and poor quality drugs as well as those that infect purchaser computers with viruses. (19) These dangers, together with a number of well-documented patient tragedies (20) where patients have died because of drugs purchased online, indicate the absolute need to address this growing phenomenon.

C. WHY CONSUMERS PURCHASE DRUGS ONLINE

Beyond perceptions of lower price, (21) why do consumers continue to purchase pharmaceuticals online given all the potential dangers and negative outcomes? The simple answer is that for some consumers, the benefits outweigh the potential dangers and/or consumers are not adequately informed or educated.

Often, buyers who enter the nontraditional market for drugs and risk receiving counterfeit and low quality materials have little knowledge of the scope or presence of that risk. Despite at least some information on the dangers of online purchasing, (22) online drug consumers have either not received the message or simply ignored it. (23) Indeed, a recent survey found fifteen percent of U.S. respondents had purchased drugs online. (24) Yet an incredible ninety-three percent of the respondents who had purchased pharmaceuticals via the Internet never considered that the products might be tainted or fake. (25)

Indeed, on deeper analysis, this lack of concern is even more worrisome. Despite the fact that more than half (fifty-three percent) of these online drug purchasers expressly noted that there is no way to tell if a drug is real or counterfeit, they still purchased the drug over the Internet. (26) Further, highlighting the naivete or lack of education of these purchasers, more than a quarter of them (twenty-seven percent) said an online seller's guarantee that the medication was genuine was good enough for them. (27) Importantly, some of the most physically and financially vulnerable patient populations are engaged in this high-risk activity. Seniors were found to be the largest age group to purchase from online drug sellers. (28)

D. VARIATION AMONG ONLINE DRUG SELLERS

There is a high degree of variability in quality and safety among Internet drug sellers. Four major types of online drug sellers exist: (1) traditional, established chain pharmacies with a web presence; (2) independent community pharmacies with a web presence; (3) stand-alone, exclusively online pharmacy sites; and (4) rogue or illegal sites. (29) Internet sellers which are in the latter two groups, and which are by far the most numerous, (30) pose the highest risk to consumers. (31)

The risk of ordering through Internet drug sellers is often directly related to the manner of order, delivery, and the type of pharmacy the patient does business with. The spectrum of ordering methods demonstrates an increasing distance from legitimacy and oversight that increases risks associated with the purchase, sale, and use of the product. Ordering methods include consumers: (a) mailing in a legitimate prescription; (b) having their physicians submit prescriptions by phone, fax or mail to an online distributor; and (c) obtaining a prescription from the website itself through an online "survey." (32)

The latter ordering method is of particular concern. The use of "cyber doctors" through which consumers may fill a prescription simply by responding to a scripted online questionnaire eliminates physician oversight of potential adverse reactions, allows purchasers to provide inaccurate and/or false information, and results in situations where patients forego needed treatment. (33) Physicians who participate in such a scheme are contravening standards of the Federation of State Medical Boards, the American Medical Association, the National Association of Boards of Pharmacy, and the Drug Enforcement Administration (34)

As might be evident from a cursory assessment, the potential for fraud and inappropriate sales of drugs over the Internet is high, particularly in the latter circumstances. Any system of drug purchasing without a substantive physician-patient relationship and a valid prescription is dangerous. (35) Of course, as noted previously, many websites simply do not require a prescription at all, allowing the unfettered purchase of drug materials over the Internet. (36) Clearly, greater risk of harm is associated with transactions that result in fake or substandard materials being ingested by patients. (37)

Some online drug sellers have responded to this risk by specifically disclaiming liability for the prescription drugs they mail to customers. (38) Some government policymakers have adopted a similar strategy. State government drug importation sites such as those in Washington, Minnesota, and Illinois have attempted to distance themselves from liability of potentially poor quality or counterfeit drugs in their online drug importation programs by requiring citizens to agree to "hold-harmless provisions" before they can access these state-sanctioned websites. (39)

III. LIMITED SEARCH ENGINE OVERSIGHT

The lack of any oversight by search engines exacerbates the risk of purchasing drugs online. This practice is particularly objectionable as both the search engines and the drug sellers obtain major financial benefits from illicit drug sales.

A. SEARCH ENGINE PROFITS

All major search engines, including Google, Yahoo, and Microsoft, receive profits through web page advertisements. Generally, websites selling products or services relating to search results are listed on a main page.

In addition, a list of sponsored links that are customized to the search terms entered usually appears either above the search results or in the right hand margin. Search engines sell or auction spots on this list, which dictates the particular positioning of the sponsored link on this list when that keyword is searched. (40) Each time a user clicks through the search engine sponsored advertisement, the search engine is paid. (41) Hence, search engines are focused on having as many advertisers as possible pay for positioning on the search engine's website.

B. INTERNET DRUG SALES

With respect to Internet drug sales, the major search engines "require" that any of their advertisers who sell prescription drugs be approved through the PharmacyChecker.com verification program. The verification theoretically requires a valid pharmacy license in U.S. or Canada, as well as correct contact information of the seller on the website and security of purchaser information. (42)

Unfortunately, the PharmacyChecker.com verification program allows for foreign and suspect online sellers to advertise on these primary search engines with virtual impunity. Compared with the National Association of Boards of Pharmacy Verified Internet Pharmacy Practice Site ("VIPPS") program, which is a rigorous evaluation system of pharmacies that use the Internet, is focused on drug safety and legitimacy, and has accredited only fifteen pharmacies, (43) PharmacyChecker.com has much less stringent requirements and has certified hundreds of online drug sellers. (44)

The ease with which online drug sellers can be PharmacyChecker.com verified is disturbing, and the implications are frightening. All of the major search engines require a website to be based in Canada or the U.S. before verification, yet, there is no way to ascertain the true locale of the drug seller. (45) International online drug sellers can therefore access U.S. patients and markets by claiming a Canadian locale. Even assuming that these websites are telling the truth about where they are located, such a claim does nothing to ensure safety. In general, domestic safety laws do not apply if drugs are not for domestic consumption. (46) For example, counterfeit or tainted drug products from China and India slated for U.S. citizens via Canadian-based online sales are unregulated by Health Canada because they are not intended for Canadian citizens: "Canadian law does not require the country to regulate or guarantee the safety of prescription medicines manufactured in foreign nations and transshipped through Canada to the United States." (47) Indeed, online Canadian pharmacies have been found to sell unapproved drugs from Mexico to U.S. citizens. (48) The sourcing of pharmaceuticals in Canada from highly suspect countries has grown alarmingly. (49) Drugs from these countries are primarily for export because they do not fulfill current Good Manufacturing Practices in Canada and therefore cannot be sold to Canadian citizens. (50)

C. AN ILLUSTRATION: RxNORTH.COM

The case of RxNorth.com illustrates the dangers of relying on PharmacyCheeker.com verification. RxNorth.com was a PharmacyChecker.com verified pharmacy and the largest Canadian Internet drug seller. It was caught selling fake drugs to U.S. citizens.

RxNorth.com was investigated after a whistleblower told a Canadian news program that the drugs RxNorth.com sold were not from Canada and were being shipped from the Bahamas. (51) Upon further detailed investigation, this was verified. (52) There were also allegations of concealed expiration dates, drugs sold near expiration, and poor quality. (53)

Although the deceptive practices were of great concern, the situation was even more problematic than appeared at first blush. In what was thought to be an unrelated investigation, U.K. authorities intercepted a four pallet shipment of pharmaceuticals from the United Arab Emirates that included "products" made by eight drug companies that were all, in fact, counterfeit. These drugs' intended recipient was Personal Touch Pharmacy, in the Bahamas. However, in a chance and chilling revelation, investigators discovered that Personal Touch Pharmacy was partnered with or the same as RxNorth.com--in fact, their computers were linked. (54)

Authorities discovered that the counterfeiting effort was extensive and sophisticated. Beyond the far-reaching international distribution system, the blister packaging of the products to be sold by Personal Touch Pharmacy/RxNorth.com was virtually identical to the authentic product. (55) Further, the fake drugs used a legitimate product lot numbers Upon being notified of these counterfeits, Bahamian authorities raided the Bahamian warehouse and found $3.7 million worth of products, spanning thirteen different manufacturers, constituting 3.025 million dosage units. (57) The Bahamian investigation indicated that Personal Touch Pharmacy and its links with RxNorth.com had annual sales of approximately $8 million. (58)

The international counterfeiting system employed by RxNorth.com illustrates a whitewashing mechanism used to disguise the sourcing of counterfeit drugs. A New York Times investigation found that the shipments used a sophisticated means of Free Trade Zones such as Dubai to shift illicit drug products that ultimately originated from China and were being sent through the U.K. to the Bahamas, and then back to the U.K. to hide their origins and promote the perception of legitimacy of the drugs. (59) It also reported that the United States Food and Drug Administration ("FDA") investigation into RxNorth.com resulted in a warning against purchasing from the online seller because of the high risk of counterfeits. (60)

Furthermore, the New York Times noted that RxNorth.com had been disciplined in 2001 by the Manitoba Pharmaceutical Association for filling more than 10,000 medication orders from U.S. patients without a valid prescription. (61) Despite this warning, RxNorth.com continued to be a PharmacyChecker.com verified pharmacy--with the highest PharmacyChecker.com rating of five checkmarks. (62) The CEO of RxNorth.com closed down operations as of January 31, 2008, transferring them to CanadaDrugs.com--another PharmacyChecker.com verified drug seller. (63)

D. UNENFORCED "REQUIREMENTS"

Beyond the fact that PharmacyChecker.com has "verified" suspect online drug sellers, allowing them to market drugs through search engine advertisements that purportedly fulfill its requirements, the search engines themselves allow sales by online sellers that in fact do not fulfill PharmacyChecker.com's requirements. As discussed above, RxNorth.com, like many other "verified" online drug sellers, dispensed medications without valid prescriptions. Even worse, other "verified" sellers are also touting addictive, Schedule II controlled substances such as morphine derivatives without a prescription. (64)

Unfortunately, over the Internet, such illicit drug sales are not the exception. As noted above, studies have revealed the large number of online drug sales that do not require a prescription. (65) Analysis of these websites also indicated that greater than fifty percent of them did not secure customer data, in direct violation of PharmacyChecker.com requirements. (66) This places buyers at risk for identity theft.

Other weaknesses attend the current PharmacyChecker.com/search engine accountability system. Online drug sellers verified by PharmacyChecker.com are not merely Canadian or domestic, as required by PharmacyChecker.com requirements. Indeed, they are listed to be in a wide array of countries, including Barbados, the U.K., New Zealand, Israel, India, Mexico, Vanuatu, Australia, as well as other countries not listed because PharmacyChecker.com does not provide a complete list of all online drug sellers its verifies. (67) This result is consistent with an FDA-commissioned study that found that of 11,000 purportedly "Canadian" websites, only 214 were actually registered to a Canadian entity. (68) Other websites selling pharmaceuticals that claim Canadian sourcing are located in Malaysia, Vanuatu, Eastern Europe, and elsewhere. (69)

Further, PharmacyChecker.com verification permits the dangerous practice of online drug sellers simply using an "online consultation" as the basis for prescription sales. For example, KwikMed.com, a verified PharmacyChecker.com site has been sued by the Arkansas Attorney General over this practice, yet the online seller still remains "verified." (70)

E. NO VERIFICATION

It should be noted that beyond poor accountability for fulfilling PharmacyChecker.com "requirements," search engines also allow non-PharmacyChecker.com verified drug sellers to advertise as well. A whole host of drug seller websites advertise on Yahoo, Google, and MSN without any "verification" at all. (71) Indeed, many of these websites are "affiliate" or mirror" sites--in other words, they are duplicate websites used to garner a larger web presence. (72) These mirror or affiliate sites generally divert traffic back to the original site and obtain a commission for doing so. (73)

In summary, search engines exert very little effort to ensure that online drug sellers from which they obtain advertisement revenue are legitimate. Yet the unregulated nature of Internet drug sales creates tremendous challenges for oversight. As a result, suspect drug products enjoy continuing sales without any oversight at all. (74) Given the vast number of online drug sellers, in combination with the total lack of accountability for search engine-sponsored sales, the scope of illicit online drug sales is large, extensive, and entirely unregulated.

IV. INTERNATIONAL AND DOMESTIC EFFORTS

Internet drug sellers pose a serious global health concern that has generated both international and domestic attention. International health organizations and governments have issued guidance to help provide consumers with important information regarding the risks involved with purchasing medications online. The effectiveness of such communications, however, is questionable.

A. WORLD HEALTH ORGANIZATION

The World Health Organization ("WHO") has recognized the dangers posed by Internet drug sellers. Its particular concern is that these Internet drug sales bypass national drug regulatory authorities, thus allowing the entry of medical products into the global marketplace that may be unapproved, fraudulent, unsafe, or ineffective. (75)

As early as 1997, WHO specifically called on its member states to "tighten controls on the sale of medical products through the Internet." (76) More recently, in response to this growing concern, WHO has collected information on various aspects and consequences of Internet sales of medical products and worked with international drug regulatory authorities, national and international enforcement agencies, consumer groups, professional associations, and the pharmaceutical industry to convene a working group to address this issue. (77) Included within this effort were surveys of drug regulatory efforts to address Internet drug sales. Results from these surveys were not encouraging, with only five countries reporting specific regulation of Internet pharmacies at that time. (78)

WHO has taken a number of steps to assist drug regulatory and other authorities to control illicit online drug sellers. These include: (1) developing a guide on medical products and the Internet available in several languages for members states to use as a model to adopt locally; (2) developing a draft Model Web Site for drug regulatory authorities to improve access to regulatory information; (3) working with the World Intellectual Property Organization ("WIPO") to control the use of international nonproprietary names of drugs and domain names on the Internet often connected with illegal sites; and (4) soliciting information from member states to assess how members regulate the promotion and sale of pharmaceuticals over the Internet and how they control the export of drugs. (79)

Despite these efforts, dangerous online drug sales continue to proliferate. Recent data from WHO estimates that up to fifty percent of drugs sold online are fake. (80) As mentioned earlier, some websites claim sourcing from and presence in "trusted" countries such as the U.K. and Canada or other industrialized countries, implying that because their businesses/drugs originate in that country, they are safe. In actuality, these drugs are illegally manufactured in poorer countries where health and safety regulation is less stringent and the potential for substandard drugs and counterfeit is much higher. (81)

This is not simply an issue for developing countries, however. For example, one of the largest fake Viagra scams was uncovered in the U.K., with counterfeits from China, India, and Pakistan being sold over the Internet to consumers in the U.S., U.K., Canada, and other developed countries. (82)

Further, a recent European analysis of Internet online sellers has reported additional worrisome results. (83) These include findings that 93.8% of online sellers have no verifiable pharmacist available for consultation, 90.3% of these sellers simply do not require a prescription before sale of products to purchasers. (84) 80.3% have no verifiable bricks-and-mortar address, 95.6% are not licensed by a board of pharmacy or other appropriate listing, (85) and, 50% did not include any patient information leaflets. (86) These results spanned drug purchases of "lifestyle" drugs such as erectile dysfunction drugs, as well as cardiovascular, respiratory, mental health, Alzheimer's, and other drugs. (87)

In addition, another recent study found that online drug sellers are rapidly increasing their business. (88) From 2007 to 2008, it appears that the same online users now visit online drug sellers at triple the rate. (89) Yet only two of the 3,000 or so online drug sellers were certified by the National Association of Boards of Pharmacy as trusted sites, with "discounts" as great as eighty-five percent--strongly suggesting counterfeits. (90)

The National Association of Boards of Pharmacy released findings in October 2008 that reported more dismal news. It found that ninety-seven percent of Internet drug sellers are operating outside of state and federal laws as well as patient safety and pharmacy practice standards. (91) Concerns with these sites include not requiring a valid prescription, not securing patients' personal information, and selling unapproved foreign drugs. (92)

WHO has attempted to involve the international community in addressing the problem. For example, WHO coordination with international drug regulatory agencies via the International Committee of Drug Regulatory Agencies ("ICDRA") aims to improve measures of protecting international public health through enhancing active collaboration among national agencies and emphasizing public education of consumers with respect to risks of online purchasing. (93) WHO has also specifically addressed the danger of Internet drug sellers and their distribution of counterfeit drugs more broadly through the WHO International Medical Products Anti-Counterfeiting Taskforce ("IMPACT"). IMPACT is an international industry-government-NGO effort to address the safety of the drug supply. (94)

Although WHO's efforts are significant, they are relatively new and early in their development. (95) Meanwhile, online drug sales continue to proliferate. The Pharmaceutical Security Institute, a nonprofit group that represents the pharmaceutical companies' corporate security directors, indicated that global seizures of tainted drugs rose twenty-four percent in 2007 from the previous year "as criminals capitalize on the growing use of the Internet." (96) Clearly, other efforts must work in concert with WHO efforts to address the challenges created by global online drug sales.

B. FOOD AND DRUG ADMINISTRATION

1. Oversight

The United States Food and Drug Administration ("FDA") is the primary federal agency tasked with addressing the issue of online drug sales. The FDA regulates this industry through enforcement of the Federal Food, Drug, and Cosmetic Act ("FDCA") and the Internet Drug Sales Action Plan ("IDSAP") adopted in July 1999. …

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