RFID Technology & HIV Treatment. Is This Controversial?

Radio Frequency Identification (RFID) tags are miniscule mircrochips, which have been shrunk to half the size of a grain of sand. These chips respond by transmitting their unique code. Most RFID tags have no batteries and they use the power from the initial radio signal to transmit their response (Dargan, 2006).

GlaxoSmithKline has begun to apply RFID technology to all bottles of their HIV treatment, Trizivir (Tablets and Capsules, 2006). Trizivir combines three drugs used to fight HIV, the deadly virus that undermines the immune system, leaving the body ever more vulnerable to infection, and eventually leading to AIDS. The components of Trizivir are all members of the category of HIV drugs known as nucleoside analogs:

Abacavir (also called Ziagen)
Lamivudine (also called Epivir or 3TC)
Zidovudine (also called Retrovir, AZT, or ZDV)

Trizivir may be prescribed alone or in combination with other HIV drugs. It reduces the amount of HIV in the bloodstream, but does not completely cure the disease. You may still develop the rare infections and other complications that accompany HIV (www.aidsmeds.net).

RFID technology has been with us since 1945. In 1945 Léon Theremin invented an espionage tool for the Soviet government which retransmitted incident radio waves with audio information. Even though this device was a passive covert listening device, not an identification tag, it has been attributed as the first known device and a predecessor to RFID technology (Dargan, 2006).

Another early work exploring RFID is the landmark 1948 paper by Harry Stockman, titled “Communication by Means of Reflected Power” (Proceedings of the IRE, pp 1196–1204, October 1948). Stockman predicted that “…considerable research and development work has to be done before the remaining basic problems in reflected-power communication are solved, and before the field of useful applications is explored.”

Mario Cardullo claims that his U.S. Patent 3,713,148 in 1973 was the first true ancestor of modern RFID; a passive radio transponder with memory. [2] The first demonstration of today’s reflected power (backscatter) RFID tags was done at the Los Alamos Scientific Laboratory in 1973 (Landt, 2001).

Why is this so controversial?

There are several documented events citing why this particular technology is controversial. The most pressing issue surrounding RFID is privacy. In my opinion, GSK’s move to include this technology on a retroviral has added more fuel to the fire.

Most concerns revolve around the fact that RFID tags affixed to products remain functional even after the products have been purchased and taken home, and thus can be used for surveillance and other nefarious purposes unrelated to their supply chain inventory functions. Although RFID tags are only officially intended for short-distance use, they can be interrogated from greater distances by anyone with a high-gain antenna, potentially allowing the contents of a house to be scanned at a distance, something distinctly Orwellian in nature. Even short range scanning is a concern if all the items detected are logged in a database every time a person passes a reader, or if it is done for nefarious reasons (e.g., a mugger using a hand-held scanner to obtain an instant assessment of the wealth of potential victims). With permanent RFID serial numbers, an item leaks unexpected information about a person even after disposal; for example, items that are resold or given away can enable mapping of a person’s social network.

GSK has indicated in defence of their position of this technology, that Trizivir was listed by the National Association of Boards of Pharmacy as one of 32 drugs most susceptible to counterfeiting and diversion (Tablets and Capsules, 2006). What is interesting about this approach to counterfeiting, is how the FDA has acknowledged and responded to this particular issue.

In 2004, the FDA conducted a number of feasibility studies that focused on regulatory requirements including electronic records, labeling, product quality and applications to pharmaceutical manufacturers, repackagers and relabelers. The Compliance Policy Guide (CPG) which was developed as a result of several brain storming sessions with industry leaders. This Compliance Policy Guide (CPG) describes how the FDA intended to exercise their enforcement discretion regarding certain regulatory requirements that might otherwise be applicable to such studies. The goal of this CPG was to facilitate the performance of RFID studies and allow industry to gain experience with the use of RFID.

The specific measures which relate to the privacy concern, were cited in the CPG (FDA, 2004):

* RFID will not be used in lieu of current labeling control systems to ensure correct labeling processes.
* The tags will not contain or transmit information for the healthcare practitioner.
* The tags will not contain or transmit information for the consumer.
* The tags will not contain or transmit advertisements or information about product indications or off-label product uses.
* A seal containing a logo, an inventory control message unrelated to the product (e.g., a message informing the custodian that the package contains an RFID tag), and/or a unique serial number may be placed over the RFID tag or elsewhere on a drug’s immediate container, secondary packaging, and/or shipping container.
* The addition of the RFID tag and seal will not block, obscure, or alter any of the product’s existing and approved label and labeling information.
* The RFID tag will not substitute for, replace, or interfere with a linear bar code required pursuant to 21 C.F.R. § 201.25.
* Participants will “read” the tags as needed to identify the product and/or conduct the study.
* The tag readers will work by emitting electromagnetic energy at radio frequencies of 13.56 megahertz, 902-928 megahertz, or 2.4 gigahertz, and at powers in compliance with regulatory requirements of the Federal Communications Commission (i.e., 1-4 watts effective isotropically radiated power).

Even though these particular specifications will utimately address the privacy concerns of consumers, in this particular case, patients with HIV using Trizivir. These particular recommendations of the CPG still contain a great deal of ambiguity. Furthermore, it appears that GSK is already in violation with one of the recommendations suggested by the FDA -“RFID will not be used in lieu of current labeling control systems to ensure correct labeling processes.”

In conclusion, this opinion piece should not be considered as banter against innovation or useful technology that protects the consumer and intellectual property (in this case, GSK). But more feasibility studies and open dialogue with consumers, infectious disease (ID) physicians and Big Pharma should be entertained, before this technology backfires on everyone.

References
Dargan, Gaurav; Johnson,Brian; Panchalingam, Mukunthan; Stratis, Chris (2004). The Use of Radio Frequency Identification as a Replacement for Traditional Barcoding. Retrieved on 2006-05-31.

Landt, Jerry (2001). Shrouds of Time: The history of RFID. (PDF) AIM, Inc.. Retrieved on 2006-05-31.

Industry News. (May, 2006). GlaxoSmithKline applies RFID tags to bottles of Trizivir. Tablets and Capsules (Formulation, Production and Packaging):4;4 pp.6.

Trizivir® (abacavir + zidovudine + lamivudine, or ABC + AZT + 3TC. [Online].http://www.aidsmeds.com/drugs/Trizivir.htm
Retrieved, June 21, 2006.

Food and Drug Administration. (2004).Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs.Guidance for FDA Staff and Industry.Compliance Policy Guides
Sec. 400.210.Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs
November.[Online].http://www.fda.gov/oc/initiatives/counterfeit/rfid_cpg.html
Retrieved June, 21 2006.

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