Although Internet drug purchasing is known to be a dicey proposition, the extent of the risk has never been established. A new report by the European Alliance for Access to Safe Medicine (EAASM), the results of which were released last week at the 4th Global Forum on Pharmaceutical Anticounterfeting, suggests the problem may be worse than regulatory agencies heretofore anticipated. In fact, more than half (62%) of all medicines bought on-line were fakes, and nearly 96% of the virtual pharmacies under study operated illegally, according to Jim Thomson, chair of the patients' rights group, which is based in Surrey, UK.
"The results of our investigation are shocking," he told the Forum. "It is astonishing to me that if I input 'buy Viagra' on my computer, I will get nearly 12 million hits. On the other hand, if I enter 'child porn,' I will get nothing."
The EAASM study, called "The Counterfeiting Superhighway,"* was designed to determine the proportion of internet pharmacies that act unlawfully and the percentage of counterfeit or substandard drugs that are sold. The researchers assessed more than 100 websties, ordering such cardiovascular, respiratory, psychotriopic, neurologic, and men's health medications as Lipitor, Plavix, Spiriva, Zyprexa, Efexor, Risperdal, Aricept, and Viagra. Experts then performed visual and laboratory analysis of the compounds. In addition to the primary findings, the EAASM reported that more than 90% of websites supplied prescription-only drugs without a prescription, 94% of the websites did not have the required pharmacist identified on the site, and 86% of online pharmacy approval stamps were fraudulent. One phony Plavix order came packed in newspaper, with free Viagra samples dropped into the wrapper as a bonus, Thomson said.
"We call on all stakeholders, including search engines, credit card companies, shipping companies, patients and regulators to take appropriate action," he states. "Online pharmaceutical purchasing has already killed people; if stakeholders don't address the problem immediately, millions will die."
First Meeting in US
The Global Forum on Pharmaceutical AntiCounterfeting is a yearly gathering of experts from the pharmaceutical industry, international and national drug and regulatory agencies, consumer groups, and the anticounterfeting technology industry. This year's meeting, the first to be held in the US, addressed "Systems for Safety in a Global Arena." The speakers and attendees agreed that, despite current enforcement efforts, the drug counterfeiting business is booming around the globe. Both developed and developing nations are affected, and the supply chain is riddled with weak links through which the unscrupulous manufacturer and trader in phony pharmaceuticals prey on the unwary consumer. Of particular concern is the parallel trade, a complex process by which a third-party wholesaler or intermediary buys low-cost pharmaceuticals from one country, say, Spain, and then sells them in a second country, England, at a higher price. The problem, as Jonathan Harper, MD, an expert on parallel trade and the author of a detailed report on the ways in which the process threatens patient safety, is that parallel trading practices take place outside the manufacturer's or licensed distributor's formal channels. This lack of oversight creates the opportunity for mischief, for the entry of counterfeit drugs into regulated chains of supply and distribution.
"The rationale for parallel trading is that it is always good to price shop," Harper told the audience. "However, the process is largely invisible and under-regulated. The parallel trade weakens the supply chain and, most important, compromises drug safety."
Parallel trading is a particular problem in Europe because the system is legal, and the various EU members have different drug pricing systems. As Roger Bate notes in his new book Making a Killing: The Deadly Implications of the Counterfeit Drug Trade, parallel trading functions much like arbitrage, in which brokers leverage price differences for a profit.1 Although arbitrage can improve market efficiency by leveling out price differences, the drug market is different from most. The high cost of pharmaceutical research and developments skews the price in wealthier markets to a point above the marginal costs of production. More ominously, by increasing the number of middlemen, arbitrage multiples the opportunity for counterfeiters to slip phony medicines into the legitimate supply chain.
"It is possible that parallel trading provides savings to payers, although this is debatable," Harper said. "However, the value that is added goes largely to intermediary traders." Moreover, he reported that the parallel trade in pharmaceuticals creates unnecessary supply system stress. It also introduces additional regulatory costs and burdens, undermines the guarantee of continuous supply, reduces incentives to invest in R&D, provides only marginal health benefit, and most important, puts patient safety in jeopardy.
"It is high time to review and codify the case law on parallel pharmaceutical trading," Harper concluded. "We also need to strengthen global trade and regulatory agreements. Patients are already at risk, and this risk will worsen if we do not act quickly."
Drug Re-Importation a Flawed Idea
In the US, parallel pharmaceutical trade is called "drug re-importation" and has been a hobby horse of so-called consumer rights groups and ill-informed politicians on both sides of the aisle for some time. But, as Peter Pitts, the president of the Center for Medicine in the Public Interest, said, the chance that an American president will ever sign a national drug re-importation law is somewhere between slim and none.
Despite what the presidential candidates say on the campaign trail, Pitts offered 4 reasons why the dangerous reality of drug re-importation trumps the obvious political appeal of low-cost medicines. First, multiple analyses show that drug re-importation won't reduce healthcare costs. Second, Americans believe re-importation will allow access to well-regulated Canadian drugs. In fact, most of the drugs received by participants in the several state re-importation programs now in operation originate from either the European parallel trade or unregulated drug operations in Asia. Once Americans learn this unsavory truth, the promise of drug importation rapidly loses its appeal, as evidenced by reason three: fewer than 0.5% of citizens in states such as Maine, Minnesota, Illinois, Wisconsin, Kansas, Missouri, and Vermont who could join a state-run re-importation plan chose to do so. Fourth, drug re-importation cannot be done safely, especially when there is evidence that such life-saving medicines as Zyprexa, Plavix, human growth hormone, and cancer drugs have been repeatedly faked. Truth be told, Pitts stated, "the US experience with drug re-importation has been dismal and a political embarrassment." Those politicians and pundits who believe that the concerns for drug safety are a red herring are failing to act responsibly. Drug re-importation is a ticking time bomb.
Other important observations heard at the Global Forum:
∑ The low risk of detection and weak penalties for conviction make drug counterfeiting attractive to organized crime and narcotics dealers. Drug counterfeiting is seen as a patent-infringement problem, not a patient-safety matter. Laws pertaining to counterfeit drug trafficking must be revised so that the punishment fits the crime;
∑ Oversight of the drug supply chain must be improved and those who are involved in the shipping, transfer, and distribution of pharmaceuticals must be held legally responsible for their actions. Sad to say, governments around the world hold tobacco wholesalers and shippers to a higher standard than those engaged in pharmaceutical traffic;
∑ New technologies to improve authentication, tracking, and information sharing are now in development. These new systems must be made practicable for patients, healthcare professionals, manufacturers, custom officials, drug inspectors, and the police and should be flexible and adaptable for use in both developing and developed nations;
∑ The pharmaceutical industry’s belated acknowledgement of drug counterfeiting has fostered the development of well-coordinated international solutions, such as the World Health Organizations' International Medical Products Anti-Counterfeiting Taskforce (IMPACT). Unfortunately, progress has been slow, and the implementation of new technologies to ensure the authenticity of the supply chain are likely to be incremental;
∑ Well-designed consumer education programs must be an essential part of the solution. Unless the public comes to appreciate its vital role in the detection and reporting of suspicious products, the implementation of new technologies to improve drug identification and authentication, such as 2-dimension holograms and radio frequency identification, will be only partially successful;
∑ The various state pharmacy electronic programs to demonstrate drug authenticity from the manufacturing plant to the point of dispensing, a process known as "e-pedigree," have run into a number of glitches along the way to implementation. In the future, it is likely that a single national standard will be developed.
* The Counterfeiting Superhighway is available at www.eassm.eu.
1 Bates R. Making a Killing: The Deadly Implications of the Counterfeit Drug Trade. AEI Press, Washington, DC. 2008.
Steven Marks is a science writer whose report on Obesity and New Pharmaceutical Approaches is coming soon from the American Council on Science and Health (ACSH.org).
See also: ACSH's full 2006 report on Counterfeit Drugs (soon to be updated).