Jan 072014
 

csipGabriel Levitt is the vice president of PharmacyChecker.com, which “collects, evaluates, and reports credentials, prices, and customer feedback regarding pharmacies that operate online and through mail-order and fax (generally referred to as ‘online pharmacies’).”

Google’s founding and funding of the Center for Safe Internet Pharmacies (CSIP)[1] should greatly concern consumers and health care providers, as well as the community of activists, academics and NGOs that focus on access to affordable medicines, intellectual property, and Internet freedom. CSIP’s activities compromise the very soul of search, the essence of the Internet as a tool for information justice, and public health. Other companies also fund CSIP, but as the leading search company, putative champion of Internet freedom, and because of its unique history of associations with online pharmacies, Google is the focus of this article.

An overview of drug affordability problems, personal drug importation, and online pharmacies in the U.S. is necessary to understand the problems with CSIP’s activities. Prescription drug prices are a major barrier to accessing medicines in America. Fifty million Americans ages 19-64 did not fill a prescription in 2012 due to drug costs, according to the Commonwealth Fund.[2] Overall, non-adherence to prescription medication, of which affordability is a major or even the greatest factor,[3] adds about $300 billion per year in additional healthcare costs from increased emergency room visits, hospitalizations and doctor visits.[4] Americans are getting sick and dying because of high drug prices.[5]

Patented medications sold in the U.S. are often over 85% less expensive online, internationally.[6] Under most circumstances, it’s technically illegal for Americans to personally import (also called parallel trade) prescription medication from other countries, but, according to the FDA, the agency has never prosecuted an individual doing so for their own use.[7] I write “technically” because those personally importing medication are not at risk for criminal prosecution. Thus, while the FDA tells Americans personally importing medication is unsafe, it de facto decriminalized.

According to the U.S. Centers for Disease Control and Prevention (CDC), about five million Americans – 2% of the adult population – buy medication outside the U.S. each year because of high drug prices at local pharmacies.[8]  Soon after Americans began to buy medication online from licensed Canadian pharmacies, about 13 years ago, drug companies and U.S. pharmacies strenuously lobbied against importation to protect profits and from avoid losing customers.[9] The pharmaceutical industry spent $2.6 billion lobbying American government officials and agencies from 1998-2012 – more than any other industry.[10] It’s more difficult to assign a dollar figure for U.S. pharmacy lobbying, but their trade associations, particularly the National Association of Chain Drugstores (NACDS), which represents the biggest U.S. pharmacies like Walgreens and CVS,[11] are allied with drug companies on this issue.

In 2009, Eli Lilly, the NACDS and LegitScript, a private online verification service which has contracts with Google and the FDA, founded the Alliance for Safe Online Pharmacies (ASOP).  ASOP’s first public effort was a submission to the White House Office of the Intellectual Property Coordinator (IPEC) with recommendations for combatting intellectual property infringement.[12] ASOP’s report to IPEC identifies “recommendations regarding the threat posed to the American Public from the sale of counterfeit and other IP-infringing drugs conducted through the Internet.”[13] ASOP’s position is that Americans should only have access to U.S. online pharmacies, essentially only those approved under standards adopted by the National Association of Boards of Pharmacy (NABP), an association representing U.S. pharmacy boards and pharmacists, which would include the verifications of LegitScript.com, a funder and founder of ASOP.[14] NABP’s president-elect has worked for Walgreens, the biggest U.S. pharmacy chain, since 1977.[15]

The call to action outlined in ASOP’s recommendations to IPEC is that the federal government, with IPEC coordinating, should “encourage” search engines and domain registrars – as well as payment processors, mail carriers, and any other “gatekeepers” –  to voluntarily take action against “rogue” online pharmacies by denying them service, including removing them from organic search results.[16] According to the NABP, all non-U.S. online pharmacies that sell to Americans are “rogue,” regardless of their safety credentials – including the safest international online pharmacies that have been in business for ten years and have perfect safety records. LegitScript.com classifies such online pharmacies as “unapproved” – a step up from rogue.

Based on over ten years of experience, independent studies, and common sense, it’s evident that there are reputable and safe international online pharmacies that sell lower cost medications to Americans and are not considered illegal where they operate.[17] This author’s mother, father, and other family members buy from such pharmacies. By any objective public health standard, properly credentialed international online pharmacies, ones that require prescriptions and dispense medications from licensed pharmacies, are not “rogue.” Nonetheless, the NABP conflates safe online pharmacies with truly rogue websites on a “Not Recommended” list as part of its Internet Drug Outlet Identification Program, which, by the way, is funded with a grant from Pfizer.[18] ASOP seeks the removal from organic searches of safe online pharmacies not approved by NABP or LegitScript.[19]

The creation of CSIP by Google and other “gatekeepers” appears to be the brainchild of ASOP.[20] Google’s first act to curtail online access to more affordable medicines was to ban licensed Canadian pharmacies that require a prescription from advertising in the U.S. Google continued its support of ASOP’s goals by founding and funding of CSIP, hiring LegitScript (a funder and steering member of ASOP), and perhaps manipulating its organic search results to disadvantage Canadian and other international pharmacies.

Through CSIP, Google sponsors an information clearinghouse and promotional online vehicle for reports, studies, and blog posts published by Alliance for Safe Online Pharmacies, LegitScript, National Association of Boards of Pharmacies, Partnership for Safe Medicines, The National Intellectual Property Rights Coordination Center, StopFakes.gov, and Permanent Forum for International Pharmaceutical Crime.[21] All of these entities are either tied to (allied with, others might argue) the pharmaceutical and U.S. pharmacy industries and/or are organizations and groups associated with maximizing intellectual property enforcement. CSIP’s website has a search portal for consumers to identify “legitimate” online pharmacies that relies on LegitScript’s NABP-approved, database. Through this functionality Google and the other CSIP members, participate in scaring Americans away from safe online pharmacies considered “unapproved” by LegitScript.

It was widely reported, and in hindsight ironic, that Google paid $500 million in 2011 pursuant to a non-prosecution agreement (NPA) with the U.S. Department of Justice relating to its admission of allowing non-certified online pharmacies that sell controlled medications without requiring a valid prescription to advertise.[22] The NPA states that it’s illegal for Americans to purchase medication from licensed Canadian pharmacies and Google attests to having known this. However, a close read of the NPA shows that the $500 million forfeiture – not a criminal fine or civil monetary penalty – was based on a combination of ad revenues and sales made by Google and, allegedly, “Canadian” online pharmacies, respectively, from the advertising and sale of controlled prescription drugs[23] (such as Oxycontin, Vicodin, Valium, Adderall, and Xanax), but not regular prescription drugs (such as Lipitor, Viagra, Plavix, Nexium and Cymbalta). Reputable Canadian online pharmacies, the ones that legitimately advertised on Google, do not sell controlled drugs to Americans and they require a prescription.  It’s clear that Google’s permitting advertising to online pharmacies that sell controlled drugs illegally was most objectionable and the activity that may well have endangered consumers, although there was no allegation of harm done to consumers. Google’s actions explain reasonable cooperation with the government in the area of online pharmacy advertisers, but it doesn’t excuse supporting ASOP’s mission though CSIP.

CSIP has even taken a position against Maine’s new drug importation law[24] that helps Maine’s residents get medication more affordably by explicitly permitting personal drug importation from licensed pharmacies in Canada and several other countries.[25] CSIP’s position is in sharp, almost comical contrast to Google’s position found in written congressional testimony in 2003, as articulated by Sheryl Sandberg, current COO of Facebook (also a CSIP member) formerly Google’s vice president for global online sales and operations.

Though these two bills are quite different in scope, objective, and approach, both contain provisions that relate to neutral Internet information services like Google. As a provider of Internet-based information tools, Google has no position on the broader merits of the drug importation debate, or on the optimal mechanisms for regulation of online pharmacies; rather, our interest is to preserve the ability of Internet users to find useful and relevant information, including information about licensed pharmacies.[26]

Google’s prior agnostic policy position on drug importation seems the appropriate one for a “neutral Internet information service.” This is turned on its head by CSIP.

Beyond domestic policy in the U.S., CSIP’s efforts have influenced international policy and enforcement priorities in a manner that perpetuates the conflation of intellectual property violations with drug safety issues. CSIP’s executive director, Marjorie Clifton, is the principal of a strategic communications and public relations firm called Clifton Consulting, LLC. In marketing her services, Ms. Clifton provides case studies on her website highlighting her experience and successes, but without mentioning organizations and names.  One such case study appears to be about CSIP:

“Coalition Building to Protect Consumers

“When the largest global Internet service providers had a call to action to protect U.S. consumer safety, Clifton Consulting developed a strategy to leverage cross-sector impact. The firm brought together important constituencies in private companies, federal agencies and nonprofit arenas to create structured communications campaigns, working groups and coordinated actions to maximize consumer protection and awareness. The result: a global model presented at the G8 Summit to enact similar efforts worldwide and virtually eliminating the threat to consumers on the platforms of member companies.[27]”

Apparently, that case study refers to language on Internet pharmacies included in the 2012 G8 Camp David Accord for which CSIP takes credit. The G8’s Camp David compliance report identifies intellectual property rights, not the public health, as the reason G8 members agreed to focus on counterfeit drugs and Internet pharmacies:

During the 2012 Camp David Summit, the G8 announced a goal of promoting economic growth and job creation in order to help the global economic recovery. Given the perceived importance of intellectual property rights for stimulating economic growth, the G8 affirmed the significance of high standards of IPR protection and enforcement, both through international legal means and mutual assistance agreements. Its commitment to exchange information on rogue internet pharmacy sites and experience in combating counterfeit medical products is a corollary of its commitment to protect IPR through mutual assistance.[28]

Global health and drug quality experts, especially those who have actually tested drug products throughout the world, including buying medications online, understand that the biggest drug safety threats are in developing countries, where substandard medications for Malaria, TB and HIV fail – not online in rich countries.[29]

Laurie Garrett, Senior Fellow for Global Health at the Council on Foreign Relations (CFR), in collaboration with experts from government, NGOs, and the private sector, submitted policy recommendations to the G8 to tackle drug safety problems. Unfortunately, they mostly went unheeded. Ms. Garrett is keenly aware that protecting the public health demands separating IP issues from drug safety. She writes:

The integrity of the global drug and vaccine supply must be decoupled from patent protection, and aggressively tackled through transparent collaborative relations between existing national safety regulators, and rapid capacity building where regulation is weak or nonexistent.

Ms. Garrett supports collaborative private sector efforts to stop rogue pharmacy sites. However, in contrast to the pharmaceutical industry-sponsored groups CSIP promotes, blocking or curtailing online access to affordable medicine is not okay – under any circumstances to Ms. Garrett. In fact, Ms. Garrett believes that government regulators have a responsibility to keep the private sector in check to protect universal access to affordable medication. She writes:

Regulators should work closely with the private sector to ensure that identification of illegal or dubious on-line retailing does not undermine bona fide provision of low-cost medicines, or diminish access to affordable drugs for all.[30]

From a different side of the political spectrum, economist and drug safety expert, Roger Bate agrees wholeheartedly with Ms. Garrett. Furthermore, Mr. Bate attributes the G8’s focus on IP and the Internet to the political power of the pharmaceutical industry, specifically its sway with the Obama administration. Of the G8 report’s IP rationale for focusing on Internet pharmacies and counterfeit drugs, Mr. Bate writes:

This is a ringing endorsement to industry folks who push IPR above all else. It also shows that the Pharma industry has far more pull with President Obama and the State Department than CFR and health experts.[31]

Branding safe and legitimate medications as dangerous does not serve the public interest or health but blocks the provisions of safe and affordable medication. For instance, legitimate pharmaceutical products were wrongly seized in the Netherlands because they were generics of medications still patented in The Netherlands through which the medications passed in route from India to Brazil.[32] A similar dynamic is at play when online access by Americans to safe and affordable medications is curtailed through publishing misleading or false information, domain seizures, ISP take downs, or search engine companies removing safe online pharmacies from organic search results.

As we observe the Obama administration going full throttle in support of pharmaceutical industry interests on several fronts, including its “deal” with PhRMA related to passage of the Affordable Care Act[33] and pursuance of pro-Pharma IP positions through the Trans Pacific Partnership, it’s not surprising that it also backs its online pharmacy agenda through IPEC.  No one doubts that Pharma doesn’t want Americans buying medications at a lower price online: in the same manner they don’t want the EU using parallel trade or lower and mid-income countries protecting the public health with compulsory licensing. But why does Google support them?

Drug price transparency is lacking for the American consumer and yet transparency is the Holy Grail to finding the lowest drug prices.[34] This opaque and secretive U.S. pharmaceutical market seems to advantage the drug companies and large U.S. pharmacy chains, many of which used to publish their online pharmacy drug prices but no longer do so.[35] The more Americans learn about how much lower drug prices are in other countries the more difficult it is for the pharmaceutical industry and their political patrons to defend the outrageously higher prices in the U.S. This is the promise of Search – a “neutral information tool” to use Sheryl Sandberg’s description – to make the world better and more just! It is the Internet – thanks in some large part to Google – that offers justice through the free flow of information to maximize benefits for consumers, including the availability of lower cost prescription medication. Google’s funding of and leadership in CSIP is an affront to its most basic principles. Worse, it’s bad for the public health.




[1] CSIP’s tax filing from 2011, form 990, http://990s.foundationcenter.org/990_pdf_archive/453/453339566/453339566_201203_990.pdf, [Last accessed 12/18/2013].

[2]S. R. Collins, R. Robertson, T. Garber, and M. M. Doty, “Insuring the Future: Current Trends in Health Coverage and the Effects of Implementing the Affordable Care Act”, The Commonwealth Fund, April 2013.

[3] “CVS Caremark Survey Says Cost is Biggest Barrier to Prescription Adherence,” CVS Caremark, 9/27/2013, http://www.prnewswire.com/news-releases/cvs-caremark-survey-pharmacists-say-cost-is-biggest-barrier-to-medication-adherence-171516471.html, [Last accessed 8/22/2013].

[4]U.S. Food and Drug Administration, 76 FR 12969, “Campaign To Improve Poor Medication Adherence,” March 2011, https://www.federalregister.gov/articles/2011/03/09/2011-5287/campaign-to-improve-poor-medication-adherence-u18, [Last accessed 8/10/12].

[5] RxSOS – “Drug Prices Are Making Americans Sicker,” http://pharmacycheckerblog.com/rxsos, [Last accessed 12/19/2013].

[6] “Online Pharmacies May Help Many Afford Prescription Medication Under Obamacare,” PharmacyChecker.com, 9/30/2013, http://www.pharmacychecker.com/news/online_pharmacy_prescription_savings_obamacare_2013.asp.

[7] “Should You Use an Overseas Pharmacy,” MoneyTalksNews.com , 2/1/2013. An email written by Christopher Kelly, Center for Drug Evaluation and Research, FDA, states: “FDA is not aware of any actions taken against an individual resulting from their purchase of small quantities of unapproved drugs for personal use.” http://www.moneytalksnews.com/2013/02/01/is-it-safe-to-use-an-overseas-pharmacy/, [Last accessed 12/17/2013]

[8]Cohen RA, Kirzinger WK, Gindi RM, “Strategies used by adults to reduce their prescription drug costs,” NCHS data brief, no 119. April 2013. Hyattsville, MD: National Center for Health Statistics. 2013, http://www.cdc.gov/nchs/data/databriefs/db119.pdf, [Last accessed 7/22/2013]

[9] “The Other Drug War 2003: Drug Companies Deploy an Army of 675 Lobbyists to Protect Profits,” Public Citizen, Congress Watch, June 2003, http://www.citizen.org/documents/Other_Drug_War2003.pdf, [Last accessed 12-18-2013]. A ProPublica article shows that a Pfizer CEOs salary increase was based on efforts to derail more prescription drug importation from Canada, as described in Pfizer’s shareholder report: see “Pfizer CEO Get’s Pay Raise For Influencing Public Policy,” Sebastian Jones, March 9th, 2010, see http://www.propublica.org/article/pfizer-ceo-gets-pay-raise-for-influencing-public-policy-309#_blank, [Last accessed 12-19-2013]. U.S. pharmacies lobby against personal drug importation through several trade associations, notably the National Association of Chain Drug Stores (NACDS). NACDS’s government affairs VP asserted in congressional testimony:  Legitimate pharmacies in the U.S. lose business each time a consumer buys from a drug importer rather than visiting their local pharmacies” in a letter to John Morrall, Officer of Information and Regulatory Affairs, OMB, from S. Lawrence Kocot, Senior Vice President and General Counsel, NACDS, dated May 28th, 2002.

[10] “Annual Lobbying on Pharmaceuticals/Health Products,” Industry Profile, 2002-2012. http://www.opensecrets.org/lobby/indusclient.php?lname=H04&year=a [Last accessed November 13th, 2012]

[11] U.S. pharmacies lobby against personal drug importation through several trade associations, notably the National Association of Chain Drug Stores (NACDS). NACDS’s government affairs VP asserted in congressional testimony:  Legitimate pharmacies in the U.S. lose business each time a consumer buys from a drug importer rather than visiting their local pharmacies” in a letter to John Morrall, Officer of Information and Regulatory Affairs, OMB, from S. Lawrence Kocot, Senior Vice President and General Counsel, NACDS, dated May 28th, 2002.

[12]Response of the Alliance for Safe Online Pharmacies to the Request for Comments from United States Intellectual Property Enforcement Coordinator and the Office of Management and Budget, For the Coordination and Strategic Planning of the Federal Effort against Intellectual Property Infringement (Federal Register Notice of February 23, 2010). http://www.whitehouse.gov/sites/default/files/omb/IPEC/frn_comments/BaneyLibby.pdf [Last accessed 12/17/2013]

[13]The Alliance for Safe Online Pharmacies’ Response to the U.S. Intellectual Property Enforcement Coordinator’s Request for Public Comment on the Development of the Joint Strategic Plan on Intellectual Property Enforcement, http://safeonlinerx.com/wp-content/uploads/2012/08/ASOP-Response-to-IPEC.pdf [Last accessed 12/19/2013].

[14] To its credit, ASOP discloses its funders: they are Eli Lilly and Company, Enforce the Act, LegitScript, National Association of Chain Drug StoresNeedyMeds, and Takeda Pharmecuticals, http://safeonlinerx.com/about-us/who-we-are/ [Last accessed 12/20/2013]

[15] Joseph L. Adams, RPh, Elected NABP President-elect at Association’s 109th Annual Meeting, http://www.nabp.net/news/joseph-l-adams-rph-elected-nabp-president-elect-at-association-s-109th-annual-meeting, [Last accessed 12/20/2013].

[16]See supra note 12.

[17]The most comprehensive and objective study of online pharmacy safety is published by the National Bureau of Economic Research: “In Whom We Trust: The Role of Certification Agencies in Online Drug Markets,” Roger Bate, Ginger Zhe Jin, and Aparna Mather, 2012. Through online mystery shopping the study found that online pharmacies, foreign and domestic, approved by PharmacyChecker.com, NABP, LegitScript and the Canadian International Pharmacy Association, required a prescription and sold genuine medication. Some counterfeits were found sold by non-credentialed sites. Tens of millions of prescriptions have been purchased by Americans from Canada and other countries over the Internet. International online pharmacies that require a prescription and fill orders dispensed through licensed sources have been found to operate very safely. Reported adverse reactions from international prescription purchases are extremely limited and related to sites that sell medications without a prescription, offer bogus remote consultations, and sell controlled drugs. Furthermore, many international online pharmacies are in full legal compliance where they operate: note that the Manitoba Pharmaceutical Association offers a special license for international online pharmacies.

[18]NABP Names 79 Internet Drug Outlets Operating in Conflict with Patient Safety and Pharmacy Practice Standards,” NABP, https://www.nabp.net/news/nabp-names-79-internet-drug-outlets-operating-in-conflict-with-patient-safety-and-pharmacy-practice-standards, [Last accessed 12/17/2013]

[19] See Supra Note 11 – pages 9-11. ASOP argues that search engines should remove “illegal” online pharmacies from natural search results, which according to its adopted classification systems would include safe international online pharmacies that sell to Americans. It even posits that the public health would “presumably” benefit from such removals. This may be the case for truly rogue sites, but clearly more Americans would go without needed medication if they could no longer find it affordable medication online.

[20] Ibid, page 7.

[21] CSIP, http://www.safemedsonline.org/resources/links/, [Last accessed 12/18/2013]

[22] An agreement between The United States Attorney’s Office for the District of Rhode Island, United States Department of Justice, and Google Inc. See http://www.justice.gov/usao/ri/news/2011/august2011/Google%20Agreement.pdf, [Last accessed 12/18/2013]

[23] Ibid

[24] “New Maine Law Allows for Importation of Pharmaceuticals,” CSIP, http://www.safemedsonline.org/2013/11/new-maine-law-allows-importation-pharmaceuticals/, [Last accessed 12/18/2013].

[25] “Maine’s Prescription for Drug Savings: Go Foreign,” PBS NewsHour, 11/9/2013, see http://www.pbs.org/newshour/bb/health/july-dec13/mainerx_11-09.html, [Last accessed 12-23-2013].

[26]Testimony of Google Inc. Before the Permanent Subcommittee on Investigations, Committee on Governmental Affairs, United States Senate, July 2004. “Buyer Beware: The Danger of Purchasing Pharmaceuticals Over The Internet.” S. Hrg. 108-684, http://www.hsgac.senate.gov/subcommittees/investigations/hearings/buyer-beware-the-danger-of-purchasing-pharmaceuticals-over-the-internet-day-2brfederal-and-private-sector-responses,  [Last accessed 12/11/2013]

[27]“Case Studies,” Clifton Consulting, http://www.cliftonconsultingllc.com/case-studies/ [Last accessed 12/23/2013]

[28] Supra note 24, page 236.

[29] Bate, Roger, Phake: The Deadly World of Falsified and Substandard Medicines, The AEI Press, 2012. See also “The Tragedy Caused by Fake Anti-Malarial Drugs,” Pierre Ambroise-Thomas, Mediterranean Journal of Hematology and Infectious Diseases, Vol 4, No 1 (2012).

[30]“Ensuring the Safety and Integrity of the World’s Drug, Vaccine, and Medicine Supply,” Laurie Garrett, May 17th, 2012, http://lauriegarrett.com/blog/2013/2/4/ensuring-the-safety-and-integrity-of-the-worlds-drug-vaccine-and-medicines-supply-final-part, [Last accessed 12/18/2013].

[31]Bate, Roger, “G8 Statement Against Counterfeit Drugs Misses the Mark,”, 5/23/2012, http://www.aei-ideas.org/2012/05/g8-statement-against-counterfeit-drugs-misses-the-mark/, [Last accessed 12/18/2013].

[32] “Thread on Generic Medicines, The European Union Ignores It,” InfoJuctice.org, REPOST, 8/27/2013. See http://infojustice.org/archives/30590#more-30590, [Last accessed 12/18/2013].

[33]Baker, Peter, “Obama Was Pushed by Drug Industry, Emails Suggest,” The New York Times,6/8/2012, see http://www.nytimes.com/2012/06/09/us/politics/e-mails-reveal-extent-of-obamas-deal-with-industry-on-health-care.html?_r=0, [Last accessed 12/18/2013]

[34] Corey, Catherine G., Tu, Ha T., “State Prescription Drug Price Websites: How Useful to Consumers,” Center for Studying Health System Change, http://www.hschange.com/CONTENT/966/966.pdf, [Last accessed 12/18/2013.

[35]Supra Note 32.

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