From fake malaria drugs to herbal supplements filled with stimulants, counterfeit medicine is everywhere. The problem is hard to track, it spans the globe, and if left unchecked, it’ll not only hurt those who take the fake drugs but everyone who needs to take medicine.
That’s according to Boston University biomedical engineer Muhammad Zaman, who is the author of Bitter Pills: The Global War on Counterfeit Drugs. Growing up in Pakistan, Zaman was always aware that certain pharmacies couldn’t be trusted, and it wasn’t until later that he realized that that’s not how it’s supposed to be. Then in 2012, a public health crisis unfolded in Lahore, the capital of Pakistan’s Punjab province: 213 people died in a matter of weeks because of heart drugs that contained toxic ingredients. “My own upbringing, my sense of fairness and justice in research, and understanding the challenges of global health — that convergence got to me and pushed me to write this book about these problems,” Zaman says.
The Verge spoke to Zaman about who is making counterfeit drugs, how they’re hurting us, and how we can try to fight back.
This interview has been lightly edited for clarity.
What do we mean, exactly, when we talk about “counterfeit drugs”? Are we talking about drugs that are intentionally made with bad ingredients? Are we talking about drugs that are made with good intentions but don’t really work?
There is a spectrum, and it goes all the way from intentional falsification, which is someone trying to deceive an unsuspecting consumer, to “counterfeit” in the legal sense, when you’re making something that might be good or bad, but you don’t have authorization and you might be infringing the patent. In the middle are poor-quality medicines that aren’t intentionally falsified but [they aren’t] meeting a certain quality standard — you make it cheaply, you’re not concerned about regulatory laws, you’re just cutting corners. There are also “degraded drugs,” which are good drugs that aren’t stored properly.
How common is this problem? How common is, say, intentionally falsified drugs versus poor-quality drugs?
The reality is that we do not know, and that’s part of the challenge, though we do know that the impact of poor-quality medicine is much higher than intentionally falsified drugs. To step back for a moment, the problem has been there for a very, very long time. Homer talks about it in his masterpieces, and there was once the problem of fake cinchona bark. It was a blockbuster drug coming from Peru to cure malaria in Europe, and there was fake bark all over Europe.
The problem is historical, and it is truly universal. And assuming it’s not a problem here [in the affluent West] is both naive and, frankly, incorrect. I wrote about an incident in New England that caused 80 deaths. There’s an incident of a Utah man who was getting drugs from all over the world and the FBI got involved, and another man in Colorado who was selling drugs through his sham internet pharmacy.
There are various numbers thrown around. For example, the World Health Organization has said that 10 percent of drugs in developing countries are fake. But the exact number isn’t known because we lack the awareness and technology to track it.
What is contributing to the rise of fake drugs? And what kind of technology would we need to track this?
There is an increase in internet commerce and e-pharmacies, and those have very little regulatory control. And there’s globalization and this huge distribution process, so one part of the drug is made in India, it’s assembled in Europe, and sold in Latin America. All of this makes the problem even more intractable.
When it comes to technology, you could imagine a tool that tells you if there’s the right amount of a chemical in a given drug. It could just tell you a simple yes or no. Or you could have a technology that gives you a more quantitative answer about the mixtures of chemicals. You need a spectrum of these, some at the customs level, at the hospital level, some are needed right at the point of care, at the pharmacy, at the hospital right before surgery. There isn’t going to be a single solution.
Plus, these technologies require a lot of infrastructure — a lot of electricity, trained people — to work. But the majority of the world doesn’t have this infrastructure because of economics and capacity, so part of the challenge is, how do you create a technology that is affordable but high-quality for these areas?
There’s often not a lot of grants to do this. Many technologies coming up on the market now are addressing the counterfeit issue — did a good company make this? — but not really addressing the poor quality of the medicine in vulnerable parts of the world. That worries me, in large part because many of the challenges, like antibiotic resistance, are going to be global challenges connected to the poor-quality medicine used in many parts of the world, not just in the more affluent areas.
Are antibiotics the biggest class of poor-quality medicines?
In terms of revenue, the most common poor-quality medicines are things like Viagra and Lipitor [for high cholesterol]. This is going to patients who have more capacity to pay, and often people in the West are buying things online that aren’t really for life-saving purposes. But from a public health level, the biggest impact is coming from counterfeit drugs like antibiotics or drugs used to control bleeding.
The problem is, if the antibiotics or drugs like anti-malarial medicines are poor quality, they generate resistance that will affect everybody — whether you are poor or rich, whether you live in the Northern or Southern Hemisphere.
Do we already know that counterfeit drugs are causing this resistance?
A good systematic report on antibiotics has never been conducted, but the circumstantial evidence and anecdotes are quite troubling. If a drug doesn’t have the right amount of active ingredients, it will lead to resistance. That link is well-established. If you don’t take the drug for long enough, that can lead to resistance, too. It will lead to problems in some of the most challenging areas, and the most challenging diseases, like multiple drug-resistant tuberculosis.
What are the most challenging areas?
China and India are up there. This is not to say that any of this is done with an implicit or explicit nod from the government or the fact that every single thing that comes out is bad, not at all. But many things coming out of those places have suspect quality. The head of the Indian version of the FDA said about four years ago if he was to use US FDA standards, he would have to shut down most of the companies in India.
There are economic reasons, lax regulation. India and China both, partly driven by international pressure, adopted the death penalty for counterfeit drugs. India didn’t adopt it. They changed it to life imprisonment, but China did. There is a cognizant concern over the fact that these are real problems.
So what can we do to try to fix it? Regulation is so difficult when it’s a global issue like this.
There are two broad categories. The first is a top-down approach, and that is going to come from the recognition that this is a problem, and countries and institutions can come together. An example that has been cited is the aviation industry. The aviation industry all over the world has recognized that poor-quality aviation parts are not going to be acceptable. There are still aviation incidents, but they’re related to maintenance, not because somebody used a bad engine. So there is precedence of institutions and countries coming together and agreeing to a certain code of conduct for products important to the well-being of individuals and the public in general. Is aviation a perfect example? Of course not, but it does give you a sense that this can happen.
The second part is bottom-up, and that one I’m even more hopeful about. That’s awareness. If you ask a typical doctor in these parts of the world if they’re aware of this problem, they’ll nod and give anecdotal examples, but they wouldn’t know what are the drivers and technologies. Even at the forefront here, pharmacy and medicine awareness is a challenge.
We have to make it a public issue. The example I give in the book is the ivory trade. It was traded widely 100 years ago, but over the years, we have decided it’s not something we want to deal with, and now even China, the biggest importer of ivory, has shut down its legal ivory trade. That’s because of international pressure. It had nothing to do with economics, it’s not like ivory was adding a lot to the Chinese economy. So we need this form of pressure as well. Within this, we need funding for more technologies, more meetings and symposia focused on bringing multiple stakeholders together.
Correction: May 24th, 1PM ET: Eighty people died because of problems with a compounding pharmacy in New England. An earlier version of this post incorrectly stated that 80 people died because of a pharmacy in Cape Cod.