Note: This is a rough transcript of episode 20 of Health Savings News and has been lightly edited for clarity. Copy may not be in its final form.
Hello and welcome to Health Savings News, the podcast about healthcare costs in America and how to save money on the often expensive care all kinds of people need. I’m your host, Evan O’Connor, joined by retired doctors Rich Sagall and Mike Woods. Each episode we discuss healthcare costs in America, offer our tips for saving money, and relevant news that affects and reflects the expensive landscape of healthcare in America. This week’s topic is counterfeit medications. As if prohibitively expensive medicine isn’t harmful enough, trying to save money can pose serious health risks if you are leaving the pharmaceutical supply chain to access affordable treatment. This week we have a guest from a resource Rich has mentioned in the past. We have with us Shabbir Safdar, the Executive Director of Partnership for Safe Medicines. Thank you so much for joining us today.
To start, can you tell our listeners what the Partnership for Safe Medicines does?
So we have been around since about 2003 studying counterfeit medicines in America. In fact, my founder, one of my three founders, was a pharmacist who was going back and forth across the Mexico border finding the medicines that Americans were buying there and bringing them back to his university lab in Texas to test for safety and efficacy, and was shocked to find that they were substandard and in some cases completely counterfeit. And he and two other gentlemen started the Partnership in order to raise awareness about the dangers of counterfeit medicines to Americans.
You just briefly alluded to that Shabbir, but what are the risks of taking counterfeit medications?
Well, there’s two risks to counterfeits. One is that they actually have something in them that is harmful, and everybody’s familiar with this. You know, most of the opioids that you get if you don’t get them from a pharmacy today are fake opioids made with fentanyl. And fentanyl is very deadly in very small amounts. And quite a bit of the drug death numbers we’re seeing, which are for the last 12 months or around 107,000, are driven by people who make like a fake oxy with an extra milligram too much of fentanyl in it and kill you upon taking it.
So just to double check. These are not street drugs. These are drugs that people are obtaining through what they thought were legitimate pharmacies or–
No, no. The fake oxies tend to come from sources that are not licensed pharmacies. And you’ll see Americans who think that they’re getting it from a real pharmacy that’s licensed in Canada, but you know, these things are not safe. The other kind of dangerous drug you get is one that we saw this year in Mexico. Americans were going to Mexico to buy blood thinners like Eliquis and xarelto because they wanted to save money. And those medicines were just chalk. They were pressed into pills that looked perfect. They were in bottles that to them looked perfect. They were in English, and they had nothing in them. Now, if you need a blood thinner, and it’s just chalk that’s actually super harmful, even though the pill itself is not causing you harm from an ingredient you’re going to end up with blood clots and strokes, which we have a report of one individual who had that happen. He got deep vein thrombosis in both legs as a result of taking placebo instead of blood thinner. So harmful ingredients and no ingredients are the two ways in which you can be harmed. I will say that you’re unlikely to get these things very, very unlikely if you go to a licensed US pharmacy.
How often do you see reduced dosage on these? Or is that a pretty rare occurrence?
No, that’s pretty typical. When you order from what you think is a safe Canadian or UK pharmacy that you find online, and 96-97% of those are all operating illegally without state pharmacy licenses. When you get a medicine from there, you’re quite likely to get a sub-therapeutic medicine that has some active ingredient in it. And the reason they do that is first: active ingredients are expensive. So if you put less in every pill, you can save some money on your profit for your counterfeit. But also one of the ways that medicine is checked when it comes into this country is they use a spectrometer that looks for specific molecules like the active ingredient of your medicine. And if it’s got a little bit of the active ingredient in it, it will pass that check but fail a more expensive, rigorous check. And so it’s worth it to put just a little bit of the real thing in the medicine so that it gets past the inspectors at customs and border protection.
Let me ask you a basic question. Sh how do you recognize a legitimate online pharmacy?
So you cannot tell an online pharmacy is legitimate by looking at it because obviously a criminal will tell you anything that you want to hear, including that they have a board of pharmacy license from your state, wherever that is. The best way to do it is to look for a pharmacy that has a domain name that ends in .pharmacy. And this is not yet well known, but we all are familiar with things like .com or .org domain names, you know, like safemedicines.org or you know, needymeds.org. But there’s actually pharmacies like — I’m gonna make one up — Joespharmacy.pharmacy. That’s actually a potentially legal domain name because domain names can now end in .pharmacy. And if you google .pharmacy domain names or .pharmacy pharmacies, you’ll find a list, and all those are licensed. They cannot get that .pharmacy domain name without actually having the pharmacy licenses here in the US that are required to deal safely. But things with like pretty silver graphics that say they’re 100% certified you just can’t believe any of that because criminals happily put those graphics on their website to convince you.
Are there other features of an online pharmacy it would cause you to be suspicious?
Absolutely. One of the obvious ones is when they tell you that they’re illegally acting. If they tell you your medicine is coming from pharmacies in Canada or India or the UK or Turkey, all of that’s illegal, right? Medicine that is made for those countries is not legal or safe for Americans to take. So if they’re doing that, they’re operating illegally, which means that they don’t have your best interest at heart. So sometimes in the small print, they’re actually very clear about that. Another way to tell is if the brand they’re advertising is not one that is a US brand, right? If they’re selling you Barelto instead of Xarelto as a blood thinner and they claim it’s a generic that’s approved in Europe, well, right off the bat, I can tell you that’s both not safe and that’s not regulated by anyone. So those are other ways that you can tell.
So does that mean that anyone buying from a Canadian pharmacy is doing something illegal or..?
It is, but you know, individuals are not a high priority target for law enforcement. So I can’t think of a single case where somebody bought from an online pharmacy something that was not a controlled substance and got prosecuted. It’s just not a big priority for law enforcement to go after patients who were breaking the law buying from unapproved pharmacies.
How many people are aware of that, I wonder, that that’s illegal.
I think not a lot. And I think…
I certainly wasn’t.
…At the point at which you’re going to do that. I think that it’s you know, you’re probably being driven by issues of financial access and cost, and you’re not anymore thinking about how illegal it is. And in point of fact, if it’s a crime that’s never prosecuted, how illegal is it really <Laugh>?
How can you tell a mail order a pharmacy if it’s in the United States it’s safe?
So mail order pharmacies in the US are required to have board of pharmacy licenses. And so if you are concerned about it, you can actually look it up. And this is true for even a bricks and mortar pharmacy. You can go to your state’s Board of Pharmacy and you can just Google, you know, Wisconsin Board of Pharmacy and they’ll have a link for pharmacy licensees and you can look it up. Even if the pharmacy, the mail order pharmacy is in Milwaukee and you live in Dallas, Texas, they’re required to have a license both in Wisconsin and in Texas in order to dispense to you through the mail. And you can look at it that way. And there’s no reason to believe that that mail order pharmacy is less safe. But there’s a lot of reasons why you want to go, if you can, to your local bricks and mortar pharmacy, preferably a community pharmacy. The your meds don’t get exposed to heat or temperature, you know, or other inclement conditions on the way to you. And the local pharmacist, you know, can have long talks if you need it, about the side effects of the medicine and whether or not it’s working for you. As well as to talk to you about ways to address cost issues like using NeedyMeds or paying cash.
I’ve seen some articles recently talking about the risk of medicine being shipped and getting outside the temperature range or humidity range that’s appropriate for the drug. Are there any mail order pharmacies in this country that have a US address that are not legit?
I am unaware of any mail order pharmacy in the US that’s operating illegally. It could be possible, but it would be incredibly reckless because it would be easy to prosecute you. Typically, the mail order pharmacies that are operating illegally are doing it from outside US soil.
Are most of the counterfeits made in foreign countries or are they made in this country?
Most of them are made in foreign countries.
And they can buy the molds? They’re easily available?
You can, yeah, you can Google it yourself. You can google, you know, pill molds online and I’ve got a whole presentation where I show pictures of them and it’s very disturbing to see a pill mold for blood thinners for sale for $200 online.
So it’s its own market, just like the counterfeit pills are?
Yes, it is.
Are medicines that are purchased at a Canadian pharmacy that you walk into, should someone feel safe about those?
I think you could feel pretty good about that, if that’s an option for you. Obviously you’ve got a problem that you’re getting medicine from someone who can’t really stand behind it, right? If something happens to you, you can’t go and sue the Canadian pharmacy. That’s just not gonna happen. What Canadians actually get is pretty safe, but what Americans get when they go on the web and start ordering from what looks like Canadian pharmacies doesn’t usually come from anywhere in Canada.
And sometimes Canada has medications available that haven’t yet been approved in the United States. So can that be a problem?
I mean, I think any medication that you decide to take that hasn’t been reviewed by the FDA or manufactured in a facility inspected by the FDA is a risk that you want to avoid taking. The world is full of manufacturing facilities that are very substandard, right? For, for the 250 that the FDA inspects in China, there’s at least 2,500 that are not being inspected because they are not making medicine for Americans and many of them are in poor shape. And without the FDA periodically showing up and using their white gloves to look for dust in the wrong places, you know, they kind of don’t care about doing the right thing. And so I feel very grateful to live in a country that has a well-funded FDA where even though I would wish they would inspect more, they do in fact go to manufacturing plants and look through their records and check their procedures.
Aren’t a lot of the drugs that we take in this country made in China or India?
Yes, a lot of them are. But the ones that are made in FDA inspected facilities, which if they’re made for Americans, they have to be, you know, are in pretty good shape. But again, there’s thousands more manufacturing facilities overseas that are not inspected by the FDA. So just saying, “well, they’re made overseas, so all overseas drugs are safe,” is definitely a risky proposition.
So let’s say you’ve gone through the process and you’ve got some medication that’s been delivered to your house. Are there any visual clues with the medication itself that might tell you whether or not it’s real or counterfeit?
Well, so it’s interesting. People ask me this question all the time, and the answer to it really requires that you be able to talk to your pharmacist because good counterfeits are almost impossible to spot — even for pharmacists, right? They, if you look at some of the fake oxycodone that are being made now by the Mexican cartels, the legitimate ones can look a little worse and less crisp than the fake ones. So you can’t usually tell by looking at it. Sometimes if it’s a sloppy counterfeit, you can tell. So I’ve seen some of the blood thinners, the fake blood thinners out of Mexico where there were typos on the label, right? And those, that’s a clear sign that what you got there is a counterfeit. But generally like you can’t, you can’t actually see from just looking at it. The only reason that Americans know their medicine is safe is because it traveled through the secure supply chain. Which is why I often say, if you wanna know if your medicine is safe, buy it from a licensed pharmacy. That’s pretty much the only way that you can be assured of it. And our incidences of counterfeits in the legitimate supply chain are very low. They’re low enough that they’re the envy of other countries.
How about the biologicals? How easy are they to counterfeit?
So what we see with counterfeit biologics is basically people selling saline because many of them come suspended in a liquid and they’re these big complicated molecules that are basically grown. I mean, it’s kind of nearly magic how those things work. You know, biologics are amazing. And, you know, they’re a little harder, but they’re obviously targets for counterfeits because, you know, many of them are literally miracle medicines. And so we do, we do see some counterfeiting, if they come in pill form, they’re very easily counterfeited by counterfeiters who just make pills. And if they come in liquid form, we don’t see sub therapeutics. What we see is basically complete placebo, you know, saline in a bottle that is the same color, which is usually clear, as the real medicine.
There are pill identification pictures like drugs.com has one and other ones have them. I’ve actually compared my own medications and they look identical to the pictures that I see at drugs.com. So you say it’s pretty much impossible to do that. So what is your opinion of these, of these sites and how useful are they really?
They’re not useful. You know, the counterfeiters buy pill molds so that they make pills that exactly match the pictures on drugs.com. So they’re way ahead of you. In fact, I’ve seen counterfeiters make hologram stickers to put on their bottles to fool consumers. They make an enormous profit and they put all their money into convincing looking packaging. They are so many light years ahead of us being able to tell as laymen what looks real and what’s not, that we don’t have a chance.
Can you give us a sort of a ballpark percentage of how many counterfeiters out there put in that kind of effort versus the ones that sort of are less stringent of what they’re making?
So almost all the counterfeits I see look very, very convincing because the actual cost of making a pill without an active ingredient is super cheap. So for $5,000, you can get yourself a pill press. For 200 bucks you can get yourself a pill mold for a therapeutic like blood thinner or a statin. And then the mix itself, you know, as long as you buy the right color powder, a couple hundred bucks will get you a lot of that. So for $6,000, you’re in the business of making fake pills. And if you sell, you know, a bottle of 30 of them for 30 bucks, it doesn’t take long to make back your costs. And so I think for the most part, you know, printing labels, printing them accurately is not hard. And most of the counterfeiter counterfeits I see look that good. The reason I keep saying it’s impossible to tell by looking at them is that the counterfeiters in general for most of the criminal industry, long move past the place where they can make perfect looking counterfeits, which means that it’s almost impossible to catch a typo or a pill misprint.
I’ve noticed a lot of medicine bottles have a QR code.
Is that something we can use to determine counterfeits?
So I’m gonna, you can’t see it cuz this is an audio only, but I have an example here. The Drug Supply Chain Security Act is a system that they’ve been implementing for nine years, and finishes next year. And it’s a tracing system that goes from the factory floor to the pharmacy shelf. It’s not really designed for patients, but if you talk to your pharmacist, you can still do a trace and every entity that buys or sells the medicine and the supply chain from the manufacturer to the distributors to the pharmacy all have to record that serial number and scan that barcode. And so it’s actually possible — and we’ve seen examples of where pharmacists have checked the history of that barcode and in some cases found counterfeit and kept it out of the hands of patients. That system is not quite complete. It finishes next year, but it’s already taking what I would say is the safest drug supply in the world, which is the Americans and making it even safer. And the barcodes are really cool. Tthey’re just not designed for consumers for a lot of reasons. But if you were to go to your pharmacist and say, “can you help me? I think at this particular bottle is not what it is, can you do a trace?” It’s possible for your pharmacist to work with you on that and, and do a trace.
So a layperson couldn’t take a QR reader and interpret that code?
No. And it’s actually not a QR code, it’s a different kind of code. Some medicine, by the way, does have QR codes and it tends to lead to a medicine information webpage. But the ones that are actually for the track and trace system are not technically QR codes.
I wonder how long it will be before the counterfeiters will figure those out.
Well, that’s the interesting thing. We’ve seen some counterfeiters try to do this by simply copying the barcodes and putting them on new labels. But because there’s a record of every entity in the chain, that doesn’t correspond, right? Like let’s say I’m Joe’s Criminal Wholesalers and I start copying barcodes from real medicine and I start selling it to pharmacies. Well, the pharmacy pulls the barcode and says, okay, I’m going to see if this is real. And they go back to the manufacturer and say, who’d you sell it to? And if you didn’t sell it to Joe’s Wholesale, then they know it’s fraudulent. It doesn’t matter that you copied the packaging, that the records that everybody else has in their systems have to match. And in fact, a pharmacist in Texas got a shipment of super cheap, too-good-to-be-true HIV medicine, and he was a little suspicious about the price. And so he called around and he found that the wholesaler that was supposed to, you know, that, that the, that the criminal told him, he bought it from says, “I never had that bottle in my warehouse.” And the pharmacist knew in that moment that what he had was fraudulent and he was like, “I’m not giving this to patients.” And so with, you know, probably a day’s, a less than a day’s worth of time, he actually was able to identify counterfeit medicine that a clever counterfeiter reusing those barcodes tried to defeat and failed to.
Well that leads to Rich’s next question…
What should you do when you suspect a fraud? Who do you report it to?
So there’s two great resources. The first is that every pharmaceutical manufacturer has a phone number you can call. It’s not all in the same place, but there’s basically always a phrase that says, “are you concerned about the quality of this medicine? Please reach out to us.” And there’s a phone number you can call, and you can actually work with them to make a report and have them go through it. The other one that’s even easier to work with is your pharmacist. You know, you can go to your pharmacist and say, it doesn’t taste the same or, you know, it doesn’t seem like it’s having the right effect, or I had an adverse event, an adverse medical event, and you know, I’m concerned about the safety of this medicine. And they also know all the processes to go through to check for authenticity of the medicine.
What should you do with the drug if you do find one that turns out to be false?
If you have a suspicion of it being false, you should set it aside and start talking to your pharmacist and then probably the manufacturer soon after. It might actually be very helpful to preserve that sample in for later testing and for the criminal investigation that might follow.
Would that be a law enforcement thing?
Yeah, believe it or not, the FDA has a department called the Office of Criminal Investigation that chases counterfeiters and they might eventually be the ones that come back and ask you for that sample.
How much tracking of counterfeiters is done? How much enforcement is there?
The Office of Criminal Investigation is one of many agencies that handles that sort of thing. And they, you know, probably pull together a couple of dozen cases that make it to the news every year. And they’re handling a whole bunch of them that are not public yet that, you know, are happening behind the scenes that we don’t get to know about. But you’ve also got FDA staff who are posted at all the entry points of the US where like packages come through the mail, you know, looking for dangerous drugs entering the US and you’ve got customs and border protection doing something similar as well as the DEA. Because of the enormous quantity of fake perfect looking opioid pills that are floating around this country right now, the DEA has become a real strong enforcement agency on counterfeit pills.
Can I backtrack to one of Rich’s questions? I’m presuming if you are going analyze a medication, you only need one sample. Our BeMedWise site always talks about “if you have unused medication, throw it out.” So if you’re ta you’re saying, you know, keep it in case it’s needed for evidence, can you throw most of them out and just keep one?
I mean, it depends on if it’s a controlled substance. If it’s a controlled substance, you often want to dispose of it because of safety concerns, right? You don’t want someone either stumbling upon it or stealing it. If they have, you know, struggling with addiction or selling it in that case, I would definitely get rid of it or surrender it to a local pharmacy. You can keep just one, but if you really think it’s counterfeit and you’ve gotten some indication, you’ll probably pretty quickly get a request for that medicine to be taken.
Okay. So you wouldn’t have to hang on to it for months far as somebody gets around to investigating it.
I hope not. <Laugh>
How do counterfeit and false medicines get into the US distribution system?
The primary way that counterfeit medicines reach American patients is American patients get them themselves. They make an affirmative proactive act to get them. They’re having trouble affording them and they don’t know about NeedyMeds or they don’t have a good relationship with their pharmacist to try and navigate the different ways to get medicine and they just decide to go online. Consumers bringing them into their medicine cabinet is the primary danger. Consumers are basically a danger to themselves when they decide to circumvent the secure supply chain, that’s the number one
Way. So it either gets mailed to them or they physically go to a location and pick it up?
Okay. But you’ve mentioned that some do get into the normal drug stream. How does that happen?
So the most recent example of counterfeit medicines, and I would say it’s ongoing, making it into the supply chain that were not brought in by consumers comes in through licensed health professionals like physicians. So we just saw a cosmetic physician here in San Francisco plead guilty to giving black market Botox and dermal fillers to her patients that she decided to order from an online pharmacy because it was cheaper than buying it from a legitimate manufacturer. And she endangered dozens and dozens of patients in that process. And that’s not an unusual story. We actually tracked from 2008 all the way up through about 2018, a wave of oncologists in America who give people chemo treatments as part of their oncology cancer treatment in office, buying these oncology products from non-licensed wholesalers around the world, Canada and others. And many of them turned out to be fake medicine and they gave it to patients directly. There was no pharmacist involved in the dispensing of them because these doctors buy and dispense this medicine. And so I would say that’s the second route by which counterfeit medicines make it into the US is that some licensed professionals who administer medicine directly decide to cut corners. And in all cases, those professionals also happen to make a lot of extra money in the process.
Yeah, that answers my last question about, you know, how the healthcare professionals can fit into this. Now do you find that most of those healthcare professionals are knowingly doing this? Or can healthcare professionals be inadvertently giving out counterfeit medication?
I would say generally, unless it’s a one-time mistake, they know they’re taking a risk with their patients and they are doing it because there’s an enormous financial windfall for them personally involved.
It seems too good to be true on the price, it probably is not true.
That is absolutely true. And in fact, if you look at it in all these cases, you know, the doctors that do this, they don’t end up providing this charity care for free as a result, right? They take an oncology medicine that should cost $2,000 a vial and they buy it instead for $800 a vial, but they still bill back insurance $2,000 a vial, and they make an extra $1,200 in the process. And that’s a real betrayal of the trust that I think patients have in their physicians and a betrayal of their commitment. But, you know, money makes people do terrible things.
Any final warning for the consumer?
In a lot of ways, you are the last line of protection for yourself. And so paying attention to your medicine, seeing if it tastes different, and having a good relationship with your pharmacist — which is not only great because you really kind of want your local pharmacy to stay in business, but because your local pharmacist knows a lot, right? Your local pharmacist knows about programs like NeedyMeds, they know about generic substitution, which can lower your cost of medicine. They know the complex intricacies of how your insurance works. They can help you navigate the cost issues as well as protect your health. And so the best thing you can do is to maybe bring them a box of donuts periodically, <laugh>.
If people wanna learn more about your organization, how should they do that?
You can go to safemedicines.org, which is our website. We have a whole bunch of resources for helping consumers find ways of saving money and if you need to go online, how to find a safe pharmacy. Lots of great stuff about NeedyMeds on our website as we have been partners for 15 years now. And you can also find us some social media, just look for the Partnership for Safe Medicines. And on YouTube for example, we do a weekly video about counterfeit medicines that we try and make as entertaining as possible.
I do subscribe to your weekly email and enjoy the videos. They are very educational and amusing.
I’m frightened enough for one day.
Yeah, <laugh>. Yeah, I was gonna say, it’s, it’s been great talking to you, Shabbir. It’s scary how the risks are more than just people not being able to afford their medications, but the risk they can find themselves in because of those conditions.
Thank you so much for joining us today. This has been a fascinating discussion. Thank you so much.
Always happy to have you guys as partners. It’s great.
Nice working with you.
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