Counterfeit drugs pose both domestic and global threats, presenting serious health risks worldwide. Although the issue is most prevalent outside the United States, Americans aren’t immune to the illegal market’s reach, as there have been far-reaching counterfeit drug cases in the U.S. As a result, there’s been a large effort to combat the problem in America. Read on to learn more about the proliferation of counterfeit drugs, and what’s being done to stop them.

What are counterfeit drugs?

According to the World Health Organization (WHO):

Counterfeit medicine is one which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.

The issue was first addressed in the 1995 WHO Conference of Experts on Rational Drug Use in Nairobi, Kenya. Since then, the market has expanded, but preventive measures have also multiplied. Most counterfeited drugs consist of antibiotics, hormones, analgesics, steroids, and antihistamines. In all, counterfeit drugs are divided into six categories: products without active ingredients (32.1 percent of counterfeits), products with incorrect quantities of active ingredients (20.2 percent of counterfeits), products with wrong ingredients (21.4 percent of counterfeits), products with correct quantities of active ingredients but with fake packaging (15.6 percent of counterfeits), copies of an original product (1 percent of counterfeits), and products with high levels of impurities and contaminants (8.5 percent of counterfeits).

The FDA believes the growth in the counterfeit drug market may be due to the escalating costs of prescription drugs, advanced technologies to develop counterfeit drugs, and the anonymity and ease of the internet.

Health Risks

The severity of the risk factors for any specific counterfeit drug will vary. Generally, they can actively cause unexpected side effects, an allergic reaction, the worsening of the existing medical condition, and/or prolong treatment periods.

A counterfeit drug that substitutes an inert substance for the active ingredient will not improve a person’s medical condition. For example, the main ingredient in Lipitor (a commonly counterfeited drug in the U.S.) is atorvastatin. Its purpose is to lower high cholesterol and triglyceride levels, and therefore reduce the risk of stroke and heart attack. If a patient believes he/she is taking atorvastatin, but in fact is consuming an inert substance, the consequences could be deadly. Even worse, in some cases, not all substituted or added substances are inert, but are instead hazardous.

 U.S. and Global Statistics About Counterfeit Drugs

The international counterfeit drug market amasses $200 billion a year. Internet sales make up $75 billion of that market. Most counterfeits are made in China and India. In the United States, 80 percent of counterfeit medicine is brought into the country from outside.

The WHO estimates that up to ten percent of the drugs sold internationally are counterfeit. In some countries this number can reach up to 50 percent. Developed countries that have strict regulations and institutions like the FDC, are estimated to sell less than one percent of counterfeit drugs. However, the United States has seen its share of highly publicized cases. With a few exceptions, the United States counterfeit market is generally focused on “lifestyle” drugs like diet, erectile dysfunction, and hair growth pills.

The counterfeit market is growing in the U.S. In 2014, an estimated 60 various Pfizer products were being counterfeited compared to just 20 in 2008. One of the most popular counterfeited pharmacy items is ChapStick. China reported holding 1,300 alleged counterfeiters and confiscating $362 million worth of counterfeit product in 2013.

According to the WHO, an estimated 200,000 people die a year due to “ineffective, fake, and substandard malaria drugs” that don’t eliminate parasites from a person’s system. To make matters worse, the fake drugs often contain a smaller dosage of the active ingredient than necessary. Thus the fake drug cures symptoms without curing the disease and fuels drug-resistant strands.

Counterfeit Drugs in the U.S.

A counterfeit maker of Avastin, a cancer drug, accessed the U.S. supply chain in 2012. This was the first major exception to the notion that counterfeits in the U.S. were limited to lifestyle drugs. Undetected, doctors and purchasing managers for oncology clinics “bought and administered the counterfeit medicines to their patients.”

In May 2012, a counterfeit version of Teva Pharmaceutical’s Adderall 30 mg tablets entered the market. The FDA labeled the counterfeit “unsafe, ineffective, and potentially harmful.” The counterfeit version did not contain the active ingredients dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amephtamine sulfate. Instead, it contained ineffective ingredients tramadol and acetaminophen. The original product is orange and peach in color with markings, while the counterfeit is white and devoid of any markings. Entering the counterfeit market for Adderall was probably seen as a lucrative opportunity, as Adderall is on the FDA’s drug shortage list, which means that it is dispersed only when available.

The drug Procrit, used to treat anemic patients with “cancer and other serious diseases,” had a large counterfeit scare in 2013. FDA investigators found three fake batches bearing three different lot numbers and expiration dates. The fake medicines contained a clear liquid with no active ingredient and two life-threatening strains of bacteria. Not only was patients’ anemia going unchecked, but already-weak patients were consuming potentially deadly bacteria. The FDA dispersed a warning to the public and provided ways to check the authenticity of the product.

Precautions to Avoid Counterfeit Drugs

There are ways to help ensure that patients and customers purchase legitimate prescription drugs. Most counterfeited drugs are sold through the internet. The National Association of Boards of Pharmacy investigated 10,000 pharmaceutical sites and found that only three percent of the sites appeared “to be in compliance with pharmacy laws and practice standards.”

Internet sites to be avoided include those outside the United States; those that don’t offer a physical address; those that don’t display a license by the applicable state board of pharmacy;  those that don’t provide a licensed pharmacist to answer questions; and sites that don’t require a prescription. Consumers should also look for the Verified Internet Pharmacy Practice Sites (VIPPS) seal. There are over 30 online pharmacies that display this seal, which was created by the National Association of Boards of Pharmacy to combat sites selling counterfeit drugs.

Consumers must also be cautious when inspecting the packaging of their product by looking for altered or unsealed containers or any physical differences in the appropriate packaging or product appearance. A change in taste and side effects could signal counterfeits as well.

 Actions Against Counterfeit Drugs

In 2012, the United States and 110 other countries participated in INTERPOL’s Pangea sting operation. The operation resulted in:

11,000 illegal online pharmacies being shut down, the removal 19,000 ads for fake drugs on social media sites, the seizure of 9.4 million doses of phony medicines…Google agreed to spend $50 million annually over the next five years to crack down on advertising for illegal online pharmacies.

Pharmaceutical companies also have their own internal investigations to fight against counterfeit medicines. For example, one method is similar to fingerprinting. Pfizer designed an infrared spectrometer that analyzes a product’s chemical bonds. Every drug has unique “reflected and absorbed wavelengths.” A graph will produce peaks and valleys–like a fingerprint–depending on the ingredients and their quantities. Those in the Pfizer lab can superimpose fake “fingerprints” over the real ones on the computer and note the differences. Further testing with X-ray diffraction can show exactly what ingredients the fake is composed of.

In 2014, Eli Lilly, an Indianapolis-based pharmaceutical company, invested $110 million in creating traceable, unique stamping codes for all of its products sold globally. The stamping codes will allow the company to trace each product from manufacturing facility to patient, and combat fakes.

The Legal Side of Drug Counterfeiting

The Prescription Drug Marketing Act of 1987 (modified in 1992) effectively closed off the United States supply chain. The law directly aimed at protecting American consumers and avoiding counterfeit drugs by providing legal safeguards. It “provides that prescription drug products manufactured in the United States and exported can no longer be reimported, except by the product’s manufacturer.” It also provides uniform standards for all distribution channels including hospitals and wholesalers.

The Food and Drug Administration Safety and Innovation Act was enacted in July 2012. It granted the FDA new and enhanced powers to regulate prescription drugs and combat counterfeit drugs in the U.S. The FDA, for example, can now “administratively detain drugs believed to be adulterated or misbranded, and the authority to destroy certain adulterated, misbranded, or counterfeit drugs offered for import.”

The 2013 Drug Quality and Security Act “outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.” Pharmaceutical companies must implement a tracking system by 2015 and tag serial numbers to each singular unit sold in the U.S. by 2017.

Conclusion

The counterfeiting of medicines is not a problem secluded to developing countries. Without proactive enforcement, counterfeit drugs could erupt in the United States. It is a highly lucrative industry for the black market. Pharmaceutical companies and consumers alike need to be responsible with prescription drugs, as the potential health risks can be deadly. This is a global problem that requires global cooperation.

Resources

Primary

FDA: Counterfeit Drugs, Questions and Answers

CDC: Counterfeit Drugs

FDA: Counterfeit Drugs

Additional

Nova Next: Cracking Down on Counterfeit Drugs

CBS News: Your Anemia Drug May Be Fake

Fierce Pharma: Lilly Steps up War on Counterfeits With $110M Serialization Program

HRF: 20 Shocking Counterfeit Drug Statistics

Medscape: Counterfeit Version of Adderall Unsafe, Ineffective, FDA Warns

PhRMA: Counterfeit Drugs

National Center for Biotechnology Information: The Prescription Drug Act of 1987

Jessica McLaughlin

Jessica McLaughlin is a graduate of the University of Maryland with a degree in English Literature and Spanish. She works in the publishing industry and recently moved back to the DC area after living in NYC. Contact Jessica at staff@LawStreetMedia.com.

The post The United States Isn’t Immune to Counterfeit Drugs appeared first on Law Street.

Could your surroundings impact your health as much as your diet, genetics, and lifestyle? The field of environmental health seeks to understand how the natural and manmade elements of our homes, work, and leisure environments impact health. To understand environmental impacts on health, experts examine a tremendous range of factors from community noise levels to the availability of public parks; some even look at dust.

I know that seems strange, because when you look at dust, I’m sure you probably see nothing but unsightly grime that makes you sneeze. But when researchers at the California Department of Toxic Substances Control look at dust, they see a possible indicator of chemicals people might be exposed to from various synthetic materials commonly found in homes.

Dust holds clues to multiple facets of your domestic life. Companies use an array of chemicals, including flame retardants, to manufacture your appliances, furniture, and even curtains. Your appliances, furniture, and curtains also contribute to the powdery detritus obscuring your coffee table. Dust offers researchers a way to investigate the holistic chemical composition of the average home atmosphere, all from the contents of a vacuum cleaner.

So why do we spend time studying dust and hundreds of other tiny environmental factors? Well, the experts in the University of Michigan video below estimate that 25-33 percent of disease globally stems from our environments. If we understood what specifically caused that percentage, we could take the first steps toward developing interventions.

With so many aspects to consider, it’s hard to make a solid connection between one environmental factor and a health outcome. But solid connections do make for golden evidence in influencing policy decisions that promote better health outcomes. A relatively new science called biomonitoring could help environmental health scientists make those golden connections by linking a pollutant directly to a health problem.

What is biomonitoring?

Biomonitoring quantifies bodily absorption of pollutants by measuring chemical amounts in human specimens like blood or urine. In the dust example mentioned above, researchers could incorporate biomonitoring by comparing the chemical composition of dust samples with the chemical levels present in residents’ blood or urine samples. This would allow them to look beyond what chemicals are present and find out if people are actually absorbing them, since atmospheric presence doesn’t automatically indicate absorption.

For example, an elemental mercury spill in a Massachusetts school caused panic when air samples revealed high mercury vapor air levels after the initial clean up. The Massachusetts Department of Public Health responded to the panic by offering urine tests. It turned out they had nothing to worry about–none of the samples indicated elevated urine mercury levels.

We worry about chemical levels in the environment because of what they might be doing to human health, but they need to be absorbed in order to cause harm. Environmental health scientists can bypass the need to study the presence of environmental pollutants one by one, by using biomonitoring to directly assess human impact. Outside of individual cases, cross-population biomonitoring data could reveal locations with disproportionate chemical exposures, a red flag that something fishy is going on.

According to the Association of Public Health Laboratories, manufacturers in the United States use more than 100,000 chemicals, yet we don’t understand what they could all do to human health. Combine this uncertainty with the rise of chronic diseases and you have a concerned public that demands many answers. Biomonitoring strives to find out which of these 100,000 chemicals make it into our bodies so we can figure out what to do about it.

How can biomonitoring affect health policy?

In the 1970s when researchers discovered that lead exposure could cause serious health problems, the U.S. implemented laws to bar it from many products like food cans, paint, and gasoline. Biomonitoring through blood testing has confirmed decreased blood lead levels since the laws were enacted, but also pointed out that low income and minority children still have levels above the CDC safe reference value, with lead in housing being the major source. After hearing these results, officials looked to housing policies as a way to decrease the problem:

• The U.S. Department of Housing and Urban Development (HUD) and the U.S. Environmental Protection Agency (EPA) required landlords to disclose lead hazards in all residences built before 1978.
• HUD made lead safety mandatory for federally funded housing and created grants for removing lead hazards from current buildings.
• The EPA began regulating painting and repair practices in all residences built before 1978.

These efforts achieved lower levels of lead hazards in government-funded housing, but did little to decrease levels in low-income or non-assisted housing.

At the state level, officials focused on finding children with elevated blood lead levels and then tried to remove lead from their environments. Some states, including Maryland, Massachusetts, and Rhode Island, implemented more prevention-based laws, but many still struggle with compliance.

To respond to a high concentration of children with elevated blood lead levels, Philadelphia officials combined public health with law in the Philadelphia Lead Court. The court was designed to increase compliance of city health codes related to lead hazards. If the court hears of a lead hazard, it issues an order to the property owner to remedy the situation. If they don’t complete hazard control activities, they’re sent to the Lead Court.

Before the court, property owners complied with lead regulations seven percent of the time. After the court was established, the compliance rate spiked to 77 percent.

These intervention successes were made possible through biomonitoring, and the connections between health and a contaminant that it revealed.

Biomonitoring and Fracking

Hydraulic fracturing (or fracking), a new and unconventional method for extracting natural gas, poses a possible health hazard to the people who live closest to fracking wells. Self reports show a disproportionate amount of respiratory problems like itchy eyes, coughing, and nose bleeds among people living near fracking wells.

Read More: Fracking is Short-Sighted in Light of Temporary U.S. Oil Boom

In this New Haven Register article, researcher Dr. Peter Rabinowitz summarizes the limitations of this self-reported data:

It’s more of an association than a causation. We want to make sure people know it’s a preliminary study. … To me it strongly indicates the need to further investigate the situation and not ignore it.

Use of biomonitoring in this instance could provide more clarity on which chemicals are present and could be causing health problems in the residents. A doctor from Aspen Integrative Health in Colorado has already tested some people who live close to drilling sites for chemical exposures. His results showed some elevated levels, but didn’t provide any conclusive links. The results could serve as a baseline comparison for other communities wishing to test residents.

The new federal rules on fracking don’t include any biomonitoring measures, but they take small steps toward understanding the possible health effects of fracking by requiring more care and accountability from drilling companies. Per the new rules, government workers can inspect fracking wells for safety, companies will have to tell the public what chemicals they use in their extraction processes, and companies will have to abide by new rules on chemical storage and disposal of flowback water.

Making Connections

The future of our health depends on our ability to make connections as we constantly introduce new chemicals into our lives through food, construction, manufacturing, and more. Environmental health scientists, supplemented by biomonitoring, work to make those connections in the hope that their findings will result in legal and policy decisions that keep people healthy.

Daunting as achieving these connections may be, daily advances, like this new University of Miami instrument to detect atmospheric mercury, bring us closer to understanding the interaction of our environment and our health. If we encourage advances in biomonitoring and other new technologies, all the vague correlations of the past could become solid connections.

Resources

 Primary

Environmental Health Perspectives: Proximity to Natural Gas Wells and Reported Health Status: Results of a Household Survey in Washington County, Pennsylvania

The Network for Public Health Law: Environmental Public Health

Additional

Association of Public Health Laboratories: Biomonitoring: Analysis of Human Exposure to Chemicals

Association of Public Health Laboratories: Measuring For Potentially Dangerous Chemicals

Public Health Law Research: Local Housing Policy Approaches to Preventing Childhood Lead Poisoning

Public Health Law Research: Public Health and Law Collaboration: The Philadelphia Lead Court Study

Public Health Law Research: Philadelphia’s Lead Court is Making a Difference

Association of Public Health Laboratories Blog: Biomonitoring and the Public Health Laboratory: Everything You Want to Know

Association of Public Health Laboratories: Biomonitoring: An Integral Component of Public Health Practice

EurekAlert: Researchers Develop New Instrument to Monitor Atmospheric Mercury

The New York Times: New Federal Rules Are Set For Fracking

Washington Post: Obama Administration Tightens Federal Rules on Oil and Gas Fracking

NPR: Interior Department Issues New Federal Rules On ‘Fracking’

The Network for Public Health Law: Environmental Public Health

Ashley Bell

Ashley Bell communicates about health and wellness every day as a non-profit Program Manager. She has a Bachelor’s degree in Business and Economics from the College of William and Mary, and loves to investigate what changes in healthy policy and research might mean for the future. Contact Ashley at staff@LawStreetMedia.com.

The post Biomonitoring: A New Way to Look at Health Policy appeared first on Law Street.