Protecting Patients: Counterfeit Drugs in Oncology and the Fight Against Them

This article is sponsored by Pfizer.

Despite strides made in cancer therapies and patient support, the rise of counterfeit drugs poses an increasingly urgent challenge around the globe—including within the United States.1-3 For oncology, these falsified products can have devastating effects: patients may unknowingly receive therapy with no active ingredient or with harmful contaminants, leading to unchecked disease progression or toxic complications.

A Mounting Threat to Oncology Care

According to the World Health Organization (WHO), counterfeit medicines impact every corner of the globe, creating a silent epidemic of substandard or falsely labeled products.1,2

Having long recognized these risks, Pfizer invests in strategies to identify, intercept, and eliminate counterfeit medicines around the world, according to Karin Tollefson, PharmD, the company’s chief oncology medical officer and Lev Kubiak, vice president and chief security officer. OncLive® spoke with Kubiak and Tollefson, who help spearhead Pfizer’s mission to combat the threat of counterfeit medicine in oncology and educate oncologists on how to safeguard patients.

Kubiak and Tollefson want health providers and patients to know about the dangers of ordering medicines from unregulated online pharmacies offering discounted prices. They explained that these pharmacies often provide substandard or counterfeit medicines. In oncology, this poses significant risks to individuals with vulnerable health conditions, who require careful and accurate administration of their cancer treatment. In addition to being treated for a life-threatening disease, if cancer patients have their regimens disrupted or tampered with by fake or contaminated medications, they may experience unexpected safety events and could lose the benefit of their treatment, putting their lives in jeopardy, they noted. Additionally, health care professionals are often unaware of the risk of online pharmacies and do not educate their patients about the risk of counterfeit medicines and the importance of safe purchasing choices.

UNDERSTANDING COUNTERFEIT DRUGS AND THEIR DANGERS

What are counterfeit drugs?

Counterfeit drugs are medications that are deliberately and fraudulently mislabeled in terms of identity, content, or source, Kubiak explained. Some contain no legitimate active ingredient at all, whereas others may contain the correct compound but at a dangerously incorrect dose.1,2 Still others might be laced with harmful fillers or chemicals. Whatever the exact composition, each of these counterfeits erodes trust in what should be a reliable, science-based therapy, Tollefson noted.

How do counterfeit drugs impact health care?

On a broader scale, counterfeit drugs are catastrophic for patients, health systems, and governments.1-3 Many times criminal rings may be involved in the distribution of counterfeit drugs while they rake in profits by circumventing authorized channels, Kubiak explained. Patients in lower-resource areas or those facing high out-of-pocket expenses are particularly vulnerable if they purchase counterfeit drugs believing they are receiving a discounted deal. Counterfeit medications, Tollefson noted, might lead to undetected disease progression, unexpected adverse effects, or the development of resistance to real medications down the line. These stories have been well-documented by multiple public health investigators.3

How prevalent are counterfeit drugs globally?

Recent reporting, such as the Johns Hopkins Bloomberg School of Public Health BESAFE 2023 Symposium report, underscore that no region is immune to fakes—both wealthy nations and developing countries face infiltration.3 “Counterfeit medicines are the number 1 most counterfeited item in the world,” Kubiak noted, explaining that there is tremendous profit in counterfeiting these drugs and no easy way for doctors to test medications to ensure that they are not fake.

For decades, Pfizer has gone to great lengths—investing in packaging safeguards, forging relationships with customs and law enforcement worldwide, and supporting academic research at institutions like Johns Hopkins—to protect patients.4 These combined efforts, Kubiak said, are designed to squeeze criminals out of the supply chain and to educate frontline providers about warning signs.

How do counterfeit drugs enter the supply chain?

Counterfeit medications continue to reach patients as criminals exploit multiple choke points in the supply chain. Tollefson explained that some rogue wholesalers cut corners and offer suspiciously cheap deals; further, unverified online pharmacies present themselves as legitimate, particularly to people who are concerned with the high cost of their cancer therapy.

Additionally, black-market channels repackage stolen or expired medications with fake labels. “If you just Google any medicine, you will get pages of what appear to be Canadian pharmacies. There is no way to know whether you will receive real medicine or not,” Kubiak explained. And, he added, many doctors in the United States are unaware of the scope of the problem.

What are some warning signs that indicate that a drug is counterfeit?

It is not easy to spot a fraudulent medication—some fakes look nearly identical to the real thing, Tollefson cautioned. Still, oncologists and affiliated caregivers can watch for certain red flags. These include inconsistent or sloppy labels (containing misspellings, blurred logos, half-torn seals), pills that appear discolored or appear to crumble, or injections that have an unusual sediment, color, or smell. She also noted that during therapy, an absence of an expected response, common adverse effects, or an unexpected toxic reaction could be red flags. Tollefson explained that laboratory testing may be the only way to definitively identify counterfeit medications. Patients should always voice their concerns to their health provider if they notice any red flags.

Why are counterfeit drugs especially dangerous in oncology?

Oncologic treatments rely on precise dosing schedules, careful monitoring, and, often, specific instructions on appropriate storage and handling, Kubiak explained. If a fake drug disrupts that balance by containing too little active ingredient or some toxic additive, Tollefson added, the entire treatment plan may collapse.

Many patients with advanced cancer do not have the luxury of wasted time.⁵ Each day matters, and that’s exactly why these criminals are striking a nerve in the oncology space. “Counterfeit medications are not medicine,” Tollefson emphasized. “They are not going to work. In the worst scenarios, they could take someone’s life. It’s indescribable and unthinkable to do this to a patient with cancer.”

For oncologists, these truths underscore the urgency of blocking the supply of counterfeit medicines to vulnerable patients.

PFIZER’S ROLE IN COMBATING COUNTERFEIT DRUGS

What is Pfizer doing to combat counterfeit drugs?

Pfizer is fighting the counterfeit crisis with a blend of technology, education, and cross-industry partnerships, Kubiak outlined. The company’s No Fakes for Health’s Sake initiative is designed to heighten global awareness with online resources, social media campaigns, and local health care alliances. Additionally, Pfizer invests heavily in tamper-evident packaging—holograms, specialized seals, and digital verification technologies—to help legitimate pharmacists and providers quickly identify real stock from suspect stock.4

Kubiak also noted that Pfizer’s global security division works directly with law enforcement and border control agencies to intercept shipments that appear counterfeit and seize the harmful products before they are stocked on pharmacy shelves. Pfizer further backs educational outreach in the form of webinars, conferences, and digital alerts, ensuring that health care professionals remain up to date on the latest scam tactics, Tollefson added. The company sponsors research at institutions like Johns Hopkins, using wide-scale surveys to understand physician awareness and propose targeted interventions for oncology.3

According to the Global Security Media Update 2024, more than 43 million doses of fake Pfizer products were seized between 2020 and 2023.4 Tackling that enormous number is only possible when Pfizer shares real-time intelligence with customs officials and local law enforcement across international borders, Kubiak noted. Pharmacies also do their part by following strict guidelines on verified wholesalers and consistently auditing their stock. In many cases, these coordinated efforts lead directly to shutting down major smuggling operations.4

“Pfizer’s been involved with this for more than 30 years. If a patient needs a Pfizer medicine, but they are getting one that is not real, then that is a problem for Pfizer,” Kubiak said. Stopping fakes is not about saving face—it is about safeguarding the integrity of therapy and, ultimately, saving lives.

Over the years, Pfizer has refined its approach by blending enforcement efforts (eg, raids, seizures, legal action) with technological safeguards (eg, packaging updates, improved distribution tracking).4 Kubiak explained that this synergy has broken up smuggling rings and helped entire patient populations in Asia, Europe, and North America from the inadvertent use of worthless or tainted chemotherapeutic agents. Counterfeiters adapt rapidly, but these accomplishments show that consistent collaboration can drastically reduce infiltration into legitimate oncologic drug supplies.4

ACTIONABLE STEPS FOR ONCOLOGISTS

What can oncologists do to help in detecting and reporting counterfeit drugs?

Counterfeiting is a highly sophisticated operation. However, Tollefson and Kubiak offered tips for steps oncologists can take to help:

• Consult official regulatory sites, such as the FDA’s registry of certified online pharmacies or the Verified Internet Pharmacy Practice Sites (VIPPS) program, to confirm that digital sellers are trustworthy.
• Gain familiarity with brand-specific packaging—often available through resources from Pfizer and other manufacturers—to help detect tamper-evident features or missing holograms. If something looks odd (eg, a peculiar label design, a slightly broken safety seal), health care professionals should stop distributing the product immediately, contact the manufacturer’s security team, and file a report with the FDA or corresponding authority.
• Subscribe to newsletters or alerts from medical associations to stay informed as new counterfeits appear on the radar.

How can oncologists help educate patients about this issue?

In everyday oncologic practice, it is easy to assume patients always use safe channels, but cost issues often nudge people toward suspiciously cheap deals, especially online. It is crucial that physicians discuss medication sourcing with the patient early—preferably right after deciding on a new therapy or changing a therapeutic regimen, Tollefson noted. Some patients may not readily admit that they ordered from an online discount distributor. Physicians can ask gentle, open-ended questions such as, “By the way, have you found a reliable pharmacy for this prescription?” If they mention anything unusual, she added, physicians should educate them about recognizing a legitimate vendor and avoiding fakes; they also can provide tips for verifying URLs, looking for recognized seals (VIPPS in the US), and not purchasing products from sites that sell prescription medications without a prescription.

Oncologists also can offer brief printed tips or a digital resource that explains red flags (eg, weird pill appearances, unbelievably low prices, websites with no clear contact information), Tollefson said. In parallel, Kubiak emphasized, they can remind patients that they can access official financial assistance programs including manufacturer co-pay aids.

Counseling patients about safe purchasing channels is crucial, Tollefson agreed, adding, “I know these treatments can be expensive, but there are legitimate discount and assistance programs patients may qualify for.” ⁴

Sometimes, an issue only surfaces after a patient notices something unusual with their treatment experience, like a lack of expected adverse effects, new and unexpected adverse reactions, or pills that look different from the last refill, Tollefson noted. If any such issues arise, Pfizer encourages oncologists to promptly trace the pharmacy used, check the packaging carefully, and, if doubts remain, escalate the matter to local or national regulatory bodies.

Working hand in hand with companies like Pfizer can greatly amplify an oncologist’s ability to detect and prevent fake drugs, Kubiak said. The company routinely organizes webinars and continuing education events that highlight real-world case studies including their own experiences with intercepting suspicious shipments. They also invite providers to share immediate feedback if they suspect a product is off, which contributes to a real-time mapping of counterfeit networks.⁷ By forging these connections, oncologists reinforce the safety net that keeps patients from unknowingly receiving worthless or even toxic medications.

Reinforcing the Importance of Addressing Counterfeit Drugs in Oncology

Counterfeit oncologic drugs remain one of the biggest threats to both patient safety and public confidence in legitimate treatments.1-3 When a criminal breaches the supply chain, oncologists may risk losing critical ground in the fight against cancer, Kubiak said. Coordinated efforts involving manufacturers like Pfizer, government agencies, law enforcement, and frontline providers are indispensable.4

The margin for error is slim, and many patients have no time for setbacks or ineffective therapy in their treatment journey. “It is criminal to take advantage of patients when they’re at their most vulnerable. We need to remind people to buy from reputable pharmacies. If it looks too good to be true, it probably is,” Tollefson explained.

Pfizer’s No Fakes for Health’s Sake education and awareness campaign exemplifies how dedicated initiatives can push awareness beyond hospital walls and reach everyday people who otherwise might be unaware of the risk. When oncologists verify wholesaler credibility, counsel patients on safe purchasing, and promptly report any anomalies, they help to dismantle the counterfeiters’ business model, Kubiak reiterated.

Ultimately, all parties—patients, providers, regulators, and pharmaceutical partners—share responsibility for weeding out fakes and defending the integrity of cancer care. Unifying around that goal offers the best chance of ensuring that patients receive the genuine, evidence-based therapies that they need.1-3

REFERENCES

1. Substandard and falsified medical products. World Health Organization. December 3, 2024. Accessed February 28, 2025. https://www.who.int/news-room/fact-sheets/detail/substandard-and-falsified-medical-products

2. A study on the public health and socioeconomic impact of substandard and falsified medical products. World Health Organization. April 6, 2020. Accessed February 28, 2025. https://www.who.int/publications/i/item/9789241513432

3. The 2023 symposium on public health strategies for combating counterfeit drugs. Johns Hopkins Bloomberg School of Public Health; 2023. Accessed February 28, 2025. https://fakemedicinenomore.org/wp-content/uploads/2024/03/BESAFE-2023-SYMPOSIUM-REPORT.pdf

4. Global security media update 2024_V8_10-28-24.pdf. Internal document. Pfizer. 2024.