For Food and Drug Administration and law enforcement officials with a special interest in cracking down on counterfeit and contaminated pharmaceuticals, September has already proved to be a very busy month.
Last week, a pharmacist in Wisconsin and a pharmacologist in Nevada were both charged with supplying “at least four million misbranded and counterfeit pharmaceuticals to an illegal Internet pharmacy based in Costa Rica that catered to U.S. customers,” according to a Justice Department press release.
Marla Ahlgrimm and Balbir Bhogal have been accused of masterminding a scheme to manufacture imitation versions of drugs like Xanax and Viagra in India, smuggle them into the U.S., and then arrange for Costa Rica-based call-centers to fill orders to American customers. Everyone involved was unlicensed, and the packages were not labeled according to FDA or Drug Enforcement Agency standards. Oh, and most importantly, the drugs were fake. Madison.com reports that the pills were found to either contain lower dosages of medicine than what they claimed, or else no real medication at all.
The prospect of millions of Americans being disappointed with the potency of the Viagra they illegally purchased from online pill peddlers is, perhaps, not the most sympathy-rousing “buyer beware” tale out there. But another legal case also developing now involves a darker tragedy. Earlier this month, agents arrested a (former) pharmacist, Glenn Adam Chin, as he was attempting to board a plane to Hong Kong at Boston’s Logan Airport.
In 2012, a damning report in the Lancet announced that a third of all anti-malaria drugs for sale in Asia and Africa, when tested, were found to be either fake or expired.
Chin was the head pharmacist of the New England Compounding Center—since closed—which sent a batch of contaminated drugs to pain clinics across the country in 2012. The medication, meant to alleviate back pain, had not been properly sterilized, and when doctors injected it into their patients, it caused an outbreak of fungal meningitis. In all, 751 patients got sick from the tainted vials, and 64 people died.
The compounding center was shut down, and its staff has been under investigation by the U.S. Attorney’s office ever since. Chin is the first person to have been arrested so far. (Chin’s lawyer told the Boston Globe last week that his client has been made a “scapegoat,” adding, “I am sure that someone needs to be blamed, but I am not sure it is him.”)
Rogue compounding centers aside, counterfeit, contaminated, and otherwise compromised medication is a worldwide problem. In 2012, a damning report in the Lancet announced that a third of all anti-malaria drugs for sale in Asia and Africa, when tested, were found to be either fake or expired. “Because malaria infects so many people, often in poor countries, margins are low and competition between legitimate brands of medicine is fierce,” as Marc Herman explained. “At the same time, the disease is so common, medicine to treat it is sold over the counter in many regions, and much of it taken without proper medical oversight.”
The consequences are deadly: When drugs aren’t potent enough, they don’t just fail to treat the patients taking them; they also contribute to the increasing resistance of malaria to drugs overall. One researcher writing in the Malaria Journal this year called the manufacture and sale of counterfeit anti-malaria drugs “a crime against humanity.”
Europe has its share of problems in this area as well. Just this month, counterfeit versions of Roche’s cancer treatment MabThera were discovered in Germany. European authorities say drug-theft and -counterfeiting is rife in Italian hospitals. And in 2012, authorities in England and Spain busted an extensive crime ring that was selling fake erectile dysfunction drugs that the gang had imported from China and Singapore.
The World Health Organization has said in recent years that about half of all drugs bought and sold on the Internet are fake, and that a tenth of all global pharmaceutical commerce worldwide involves counterfeits. The WHO has cited INTERPOL raids throughout Asia, the Middle East, and Africa that uncovered counterfeit drugs ranging from antibiotics to birth control, from organ transplant drugs to medicine for schizophrenia.
In fact, even the worldwide proliferation of counterfeit Viagra is no joke. Counterfeit drugs can have less-potent dosages than they are supposed to, but they can also contain entirely different, harmful ingredients. The WHO reported an episode in 2008 in Singapore in which drugs purportedly meant for erectile dysfunction actually contained glyburide, a medicine typically taken by diabetics. The drug sent 150 people to the hospital with severe hypoglycemia; seven patients suffered brain damage and four people died.
Those who work to stem the flow of fake drugs around the world have a set of complicated obstacles before them. As economists Erwin Blackstone, Joseph Fuhr, and Steve Pociask succinctly put it in the journal American Health & Drug Benefits in June:
Internet pharmacies, which are often the source of counterfeit drugs, often falsely portray themselves as Canadian, to enhance their consumer acceptance. Adding to the problems are drug shortages, which facilitate access for counterfeits. A long and convoluted supply chain also facilitates counterfeits.... Trafficking in counterfeits can be extremely profitable; detection of counterfeits is difficult, and the penalties are modest.
The researchers recommend that the punishments for manufacturing and selling counterfeit drugs should be much harsher, and authorities should put more resources into educating the public about the dangers of ordering drugs from online pharmacies.
Most surprisingly, the authors also suggest that the tech world could join the fight, by helping to “construct Internet search algorithms so that legitimate online pharmacies appear first.”