IMPOSTERS in the Medicine Cabinet

One hundred dollars for 360 tablets of generic Synthroid? Good deal. With a click, I add them to my digital shopping cart, and for good measure, toss in 60 250-mg Zithromax pills, 90 generic Glucophage tablets, and a few months’ supply of generic Yasmin before hitting checkout.

I’m shopping at an online pharmacy I found through a Google search. The site looks professional, with customer reviews, a picture of a reassuringly white-coated man with a stethoscope, and plenty of social media–sharing options. What’s not present is any requirement to provide a doctor’s prescription for the purchase of these drugs. However, a medical questionnaire asks for my age, sex, and medical conditions, in case their in-house doctor wants to check the order over. Good enough?

Caveat emptor. The site is on the National Association of Boards of Pharmacies’ (NABP) “Not Recommended” list, meaning it’s one of hundreds the organization suspects could be selling counterfeits. If I were to go through with the sale (which I am not), I couldn’t be certain about where the products really came from or what they actually contained. They might have drugs inside, but they also might contain cement powder, floor polish, lead, dextrose, rat poison, or some completely different therapeutic altogether—all ingredients that have been identified in counterfeit pharmaceuticals intended for the unwary public.

Right now, fake medicines are a multi-billion-dollar problem, affecting consumers in virtually every country and demographic in the world, and the problem is getting worse. It has been estimated that up to 15 percent of drugs sold worldwide are counterfeit, and in parts of Africa and Asia, that figure can surpass 50 percent. In the United States, the problem is comparatively less severe thanks to our strictly regulated pharmaceutical system, yet we are still vulnerable.

According to the World Health Organization (WHO) and the NABP, less than 1 percent of the pharmaceuticals in the United States are fraudulent, but in a country that spends $320 billion on 3.7 billion prescription drugs a year, even a fraction of 1 percent is in the millions. In the past 19 years, the U.S. Food and Drug Administration (FDA) has initiated 580 counterfeit drug arrests, and this year alone, it has had to warn consumers and clinicians away from ineffective fakes of the anticancer drug Avastin, useless versions of the ADHD medication Adderall, and ersatz Vicodin.

These modern iterations of snake oil began in the late 1990s with the globalization of pharmaceutical manufacturing, the commercialization of the Internet, and the blockbuster success of Pfizer’s erectile dysfunction drug Viagra. The sheer profitability of the drug—it grossed the company more than a billion dollars in its first year—led to counterfeits almost immediately. By 2002, hundreds of thousands of fake Viagra pills flooded the market. Nothing is off limits today: birth control pills, hormone replacements, diabetes treatments, weight-loss aids, cancer and transplant drugs, schizophrenia medicines, and HIV therapies have all been counterfeited. Internet pharmacies hawk pills, injectables, IUDs, even stem cell therapies promising to cure everything from autoimmune disease to autism. Most—but not all—of the manufacturing appears to take place in loosely regulated countries like China and India, but the selling occurs through online pharmacies worldwide.

Because of the obesity epidemic, metabolic and endocrine drugs are particularly appealing to drug forgers. In 2010, the rate of counterfeiting incidents in the metabolic therapeutic category—which includes glucose test strips and blood sugar stabilizers—shot up by 182 percent. Because many endocrine drugs come in the form of injectable biologics like insulin, they can be even easier to counterfeit than tablets, says Marvin Shepherd, president of the Partnership for Safe Medicines.

“You can just use sterile water, or tap water if you want. All you have to do is just copy the container,” he says. Biologics also require particular handling, like refrigeration, to maintain their efficacy. This makes even genuine insulin suspect if it gets diverted from legitimate routes to be sold through gray market vendors, as happened in 2009 when insulin stolen out of North Carolina showed up in a sick diabetes patient in Houston. (To this day, only 3 percent of the 129,000 vials stolen have been recovered.)

Obtaining the equipment and supplies to produce fakes and creating the online pharmacies from which to sell them are simple, experts say. “You can pretty much go from soup to nuts in creating your own online pharmacy,” says Tim Mackey, a doctoral researcher at the University of California, San Diego School of Medicine. “You can get the API [active pharmaceutical ingredient] from China, you can get the pill printers from China.”

Slap together a pretty Web page and you’re good to go. “Literally, if we sat here for about 45 minutes, we could create our own online pharmacy,” says Bryan Liang, executive director of the Institute of Health Law Studies and Mackey’s advisor. “By the end of the day, we’d have orders.”

Accountability for these pharmacies is nonexistent for the most part. Of 10,065 Internet drug outlets surveyed by the National Association of Boards of Pharmacy, only 73 sites (0.73 percent) had been accredited through the association’s verification programs and 9,734 (96.7 percent) were out of compliance with legal or patient safety standards.

Although the majority of people who buy medicines on the Internet use pharmacies associated with their health insurance plan or a local pharmacy, FDA spokesperson Sarah Lynn-Clark writes in an email, “We are concerned about the portion of Internet purchases from online sources that may be from fraudulent, illegal online pharmacies.”

Global Pharmaceuticals

Another element feeding the phenomenon is the globalization of the pharmaceutical industry. As with electronics, medicine making has become a team sport. According to FDA commissioner Margaret Hamburg, 80 percent of the ingredient-manufacturing sites for FDA-approved drugs sit outside the United States, located in one of the 300,000 facilities across 150 different countries that export FDA-regulated products into the United States. Every link in the chain offers criminals a weak point from which to steal or introduce adulterated and counterfeit products.

“It is an enormous task keeping track of that and keeping it from being contaminated,” Shepherd says. “They can do the spectrophotometry analysis and sometimes it works, and sometimes it doesn’t”—as with the fatally contaminated heparin in 2007 that killed at least 149 people.

However, nations and regulators are fighting back. The past decade has seen breakthrough collaborations between national and international public health agencies. The FDA and WHO have joined forces with law enforcement organizations like Homeland Security Investigations, Customs and Border Protection, and Interpol. Agencies also team up with private pharmaceutical companies and technology players, among them Google and GoDaddy, whose accessible services are often exploited by counterfeit rings. The largest such venture to date, a 100-country, WHO-led sting operation this fall called PANGEA V, seized 3.75 million doses of counterfeit and illicit drugs and resulted in the arrest or ongoing investigation of 79 people, as well as the elimination of more than 18,000 illegal online pharmacies.

Meanwhile, pharmaceutical manufacturers and the FDA continue to develop new anti-counterfeiting techniques in what has become an arms race against drug forgers. The FDA recently unrolled a new, handheld counterfeit detection device—CD3—designed to analyze chemicals and potential tampering in everything from outsets to inserts, hidden codes, and print—in real time. Relatively cheap ($1,000), battery-operated, and easy to use with a minimum of training, the technology has already become a valuable tool for the FDA. “Due to its portability, it is currently being used by FDA agents in the field to rapidly screen for potentially problem products,” Clark writes.

Similarly, many pharmaceuticals now put identifying markers on drug packaging. Some of these can be seen with the naked eye—like holograms—or can be scanned in bulk from a distance, like radio frequency identification (RFID) tags. Others are more covert: UV fibers woven into the packaging, inks and images that can be seen only under specific wavelengths or filters. Nanotechnological markers and DNA or chemical tags incorporated into the makeup of the drugs themselves add a further layer of complexity to the drugcounterfeiting process. Illinois-based NanoGuardian, for instance, has created a multi-layer nanotechnology that can embed everything from the drug’s strength and expiration date to its origin and destination—more than 350 codes of information—carved directly onto the drug in a space smaller than the width of a single hair.

These technologies will mitigate the risk, but “none is perfect,” warns Sebastian Mollo, Intelligence Director for the Americas at the Pharmaceutical Security Institute. “They don’t solve the problem. They’re just one piece of the puzzle.” Although agencies focus on Web site marketing, counterfeiters are moving on to new territory: in a recent study, Liang found illicit contraceptive sellers targeting consumers through social media platforms like Facebook, Twitter, and Flickr.

Still, Liang is optimistic. The increase in private and public agency collaboration marks a significant step forward, and transparency and public awareness are at unprecedented highs. It’s still early days, he says, but “we are starting to see both technology and global governance that can integrate and get the job done of ensuring a safe drug supply.”

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