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Avastin scandal throws a spotlight on trade-activity monitoring
In the ongoing counterfeit Avastin scandal, it has become clear that this was not a case of products so closely mimicking legitimate product that buyers were fooled. FDA, which published photos of the fake product, noted that it has the wrong manufacturer displayed, and has obviously bogus lot numbers. Rather, the fake product simply went via a non-standard distribution chain, from (apparently) a specialty distributor into clinics and doctors’ offices. (Some doctors, especially oncologists, purchase and dispense products directly rather than sending patients to a pharmacy, as do most hospitals; the completely legal practice is known as “buy and bill.”) If the doctors buying the fake product are not profoundly negligent, then they must be extremely naïve.
Genentech, in responding to the first wave of news about the fakes, noted that there are only four authorized distributors of the Avastin product, and that clinics should purchase Genentech drugs only through these companies.
So, the question is, how can a manufacturer find out what is going on with its brand in unauthorized, or illegal, or non-standard distribution channels? One way, already in selective use by a number of life sciences companies, is to hire a vendor who monitors the Web for suspicious activity. The activity ranges from actual product showing up on EBay, Craigslist or other consumer-oriented commerce sites, to individual distributors and pharmacies, to business-to-business bulk trading sites that can ship carloads of fake pills or APIs. “We use proprietary software to monitor these sites, looking for references to brand-name products and APIs,” says Tara Steketee, senior manager for brand protection at OpSec Security (Boston). “The sources include counterfeit product, diversions, grey marketing and black marketing of stolen goods.” She adds that when pharma clients receive this information, they can alert law enforcement and regulatory authorities, and there have been numerous shut-downs of these sources.
The online pharmacy world—already well known as a source of illicit prescription products of uncertain quality—is only part of the picture. Google paid a $500-million fine to the US Dept. of Justice for not policing illegal pharmacy promotion on its site this year, but that has by no means put a stop to the activity. Steketee says that many online pharmacies are individual’s storefronts designed to collect consumer queries; the actual transactions occur at a hub site that might have dozens or hundreds of storefronts feeding into it. Shutting down one or a few storefronts isn’t effective; OpSec online tools can uncover where the hub site is.
OpSec, which is a multinational company providing security printing and identification technologies for many activities besides pharma products, is only one of the vendors of this service. SICPA, based in Basel, Switzerland, has a similar setup; there are also online-only companies such as MarkMonitor (San Francisco) and New Momentum (San Rafael, CA) that have done work in life sciences.