The Dangerous World of Counterfeit Prescription Drugs
By: Counterfeit prescription pharmaceuticals are a growing trend, widely recognized as a public health risk and a serious concern to public health officials, private companies, and consumers.
In some countries, counterfeit prescription drugs comprise as much as 70 percent of the drug supply and have been responsible for thousands of deaths in some of the world’s most impoverished nations, according to the World Health Organization (WHO).
In most of the world’s developed countries, however, effective regulatory systems and market controls cause an extremely low proportion of counterfeit drugs, usually below 1 percent. Even so, patients in developed countries can be affected by counterfeit drugs, and deaths linked to them occur every year in the U.S. and Western Europe—and even more often in South America, Asia, and Africa.
Counterfeit pharmaceuticals are undoubtedly a billion-dollar industry, though some estimate it to be much larger. Peter Pitts, president of The Center for Medicine in the Public Interest and former FDA associate commissioner, estimates that in 2010, activities related to counterfeit drugs generated $75 billion, based on information obtained from government organizations. He expects it to grow by 20 percent annually in the coming years. If this estimate is correct, the counterfeit drug industry generates nearly as much cash as the world’s fourth-largest health care company by revenue, AmerisourceBergen, which has generated approximately $79 billion over the past 12 months.
In this CNBC.com special report, we take an in-depth look at the world of counterfeit pharmaceuticals, from the dangers they pose and where they’re made, to what is being done to combat them.
What Are Counterfeit Drugs?
Counterfeit pharmaceutical drugs are fraudulently produced or mislabeled medicines purchased by consumers who believe them to be legitimate. These drugs can cause a range of serious health concerns. Fake pills may look nearly identical to their genuine counterparts, but may be incorrectly formulated and produced in substandard conditions.
They are, by definition, not subject to the same regulatory scrutiny as legitimate medications. The drugs often have incorrect amounts of active ingredients, if those ingredients are present at all, and are illegal in developed countries.
Pharmaceuticals are also considered counterfeit if the genuine products are stolen or repurposed and “up-labeled” — a process in which pills of one dosage are placed in bottles listing higher dosages. For example, counterfeiters may use legitimate capsules with 10mg of active ingredient and sell them in bottles with labeled dosages of 40mg. Even individual components of pharmaceuticals can be counterfeit, requiring both companies and regulators to scrutinize suppliers to avoid illicit compounds entering legitimate facilities.
Both brand-name and generic pharmaceuticals are susceptible to counterfeiting, posing problems for any corporation producing legitimate drugs. According to a report by the WHO, in addition to pharmaceuticals, medical devices and medical-related products have also been counterfeited, including blood glucose test strips, contact lenses, surgical instruments, and even condoms.
Which Drugs Get Counterfeited?
An internationally recognized criminal market, the counterfeit drug industry is difficult to track, but several attempts have been made to understand the types of drugs affected.
In a 2008 report, the WHO’s International IMPACT used seizure information to estimate the proportion of counterfeiting done by category. The findings revealed that the most counterfeited drugs were in the genitourinary category (37 percent of law enforcement seizures), followed by anti-infectives (12 percent) and central nervous system drugs (12 percent). Genitourinary medicines include treatments for sexually transmitted infections and diseases, as well as sexual dysfunction and contraception. This category includes drugs such as the erectile dysfunction drug Viagra — believed by both companies and international organizations to be the world’s most counterfeited drug—as well as medications for HIV and AIDS. According to Pfizer, the maker of Viagra, the drug was the company’s most counterfeited product, accounting for approximately 57 percent of seizures of Pfizer products in 2010.
The Pharmaceutical Safety Institute (PSI) recently analyzed total seizures and found that in 2010, the most dramatic trend in counterfeiting took place in the “metabolism” category—up by 182 percent, a category that includes diabetic medical products such as Glyburide and even diabetes test strips. Tom Kubic, president and CEO of PSI, told CNBC.com that “with the global rise of diabetes, we see a concomitant interest of counterfeiters in making counterfeit versions of drugs needed to treat this condition.”
The WHO and other government groups have also tracked examples of counterfeit drugs and list examples from brand names such as Lipitor (cholesterol) and Zyprexa (anti-psychotic) to anti-diabetics, anti-obesity, and anti-malarial drugs. The FDA confirmed that counterfeit versions of legitimate drugs, including Ambien, Xanax, Lexapro, and Ativan, are available for Americans to purchase online. Although counterfeit drug production was originally concerned with lifestyle medications treating non-life threatening conditions, the industry has expanded to produce nearly every type of medicine.
Dangerous ingredients and deadly consequences
Ingredients Found in Counterfeit Drugs
The dangers of counterfeit drugs are two-fold. First, counterfeit drugs may contain an incorrect amount of active ingredient or no active ingredient at all. The public health risk for this type of counterfeit drug is significant, since users of these medications intend to treat an illness or a disease. By using counterfeit medicines, they may be going untreated. This can result in treatment failure, increased resistance to treatment, and even death, according to the WHO.
Some counterfeits have little or no active pharmaceutical substance — many contain innocuous ingredients, although nothing an individual would want to ingest when expecting medication. These ingredients have included chalk, flour, vitamins, talcum powder, or sugar, which, when taken with the expectation of having a pharmacological effect, can be fatal.
On the other hand, many more noxious ingredients have been found in counterfeit drugs. INTERPOL reports that rat poison has been found in fake medicines, while Patrick Ford, Pfizer’s head of global security for the Americas region, says substances such as floor wax have been found in seized counterfeit products. The FDA has reported cases in which consumers ingested tablets they believed to be Ambien or Xanax that, in reality, were counterfeit. These pills contained the anti-psychotic haloperidol; ingesting them resulted in the need for hospitalization.
However, as Pitts of the Center for Medicine in the Public Interest, points out, “It’s generally bad business to kill your consumer, and it’s not in the interest of counterfeiters to hurt you outright.” Counterfeiters are more likely to produce drugs containing inert substances, he says.
Nearly a third (32.1 percent) of reported counterfeits contained no active ingredient, according to an analysis done by the WHO in 2000. Another 20.2 percent had incorrect quantities of active ingredients; 21.4 percent contained the wrong ingredients; 15.6 percent had the correct ingredients, but fake packaging; 8.5 percent contained high levels of impurities; and 1 percent were copies of an original product.
Deadly and Dangerous Examples
Although some medications are more frequently counterfeited than others, any drug—from pain medication and antibiotics to lifestyle drugs and even animal medications—can be counterfeited. One of the most notable recent examples is the blood thinner Heparin, which in 2008 was found to have counterfeit active ingredients sourced from Changzhou SPL in China.