Giachino (00:04.0940 - 00:26.0994)
Welcome to IP Protection Matters. I'm your host Renee Giachino. Today we are joined by Shabbir Safdar. He's the Executive Director of the Partnership for Safe Medicines. We will be talking today about combating global counterfeiting in pharmaceuticals, as well as lots of other issues. Shabbir, thank you so much for joining me. Welcome to the show.
Safdar (00:26.0000 - 00:28.0000)
Thank you for having me.
Giachino (00:28.0000 - 00:35.0000)
Before we start, I have to know how you got started playing in a bluegrass band. I found that quite interesting.
Safdar (00:35.0645 - 01:17.0150)
I was turning about 45 and on an airplane ride that was probably my 70th of the year. It felt like the 70th. I made a commitment to myself that I was going to do something that was more fun and less work and try and put a little bit of balance back in my life. I love the bass. I love the upright bass. So I committed to learning it and it turns out that my friends who had a bluegrass practice group needed a bassist. So I picked it up and immersed myself in the bluegrass cannon, which is pretty funny for a kid named Shabbir Safdar to be playing bluegrass with his half Pakistani heritage, but it's been really fun.
Giachino (01:17.0269 - 01:37.0055)
Good for you. I'm glad that you found something. That work-life balance is always important. Let's turn to work now. Tell us about the Partnership for Safe Medicines. For folks who want to go there and learn more on their own, we encourage them to go to safemedicines.org. What is the mission of the Partnership for Safe Medicines?
Safdar (01:37.0294 - 02:15.0570)
Our mission is to speak up for and alert people to problems in supply chain security that would endanger American patients. Basically, if there's a chance that you will get a counterfeit medicine or that an American is likely to get a medicine that would be problematic because of the safety of the supply chain, we speak up for it. We are a coalition of manufacturers, wholesalers, pharmacists and patients, really the supply chain that handles the medicine that we all depend upon to live, that all agree on not a lot of things, but we do all agree on the fact that the supply chain needs to be tight, secure and safe.
Giachino (02:16.0100 - 02:55.0020)
You say the likelihood that you might end up getting an unsafe medicine, and in many instances a counterfeit medicine, I think most of us should know about and be afraid of the dangers of these counterfeit medicines. But sadly not everybody knows that it exists. I'm sure that with the marked increase in the sale of medicine and pharmaceuticals over the internet, obviously your work and that of the Partnership for Safe Medicines has become even more critical. What do you see as the latest trends when it comes to these counterfeit drugs making it into the American supply chain?
Safdar (02:55.0240 - 04:44.0779)
The supply chain itself is really resilient. I will say that one of the problems of educating Americans about the dangers of counterfeits is that our supply chain is so secure that it doesn't happen often enough that they have a healthy worry about it. It's sort of like none of us are really worried about getting polio because polio is a solid two generations removed from any of our experience, but it does happen and it is happening a little bit more right now.
One of the things that we look at is what are the economic pressures that affect the supply chain. In our minds, the economic health of the supply chain is equal to the security of the supply chain. I'll give you an example. Pharmacy benefit managers (PBM) and insurance companies have a habit for the last 10 years of reimbursing a pharmacy for less money than what they pay for a medicine. So if you get a $1,000 Ozempic pen every month, and it costs the pharmacy $1,000 to buy it, the insurance company probably gives them like $950, which means when you walk in the door, your poor pharmacist loses $50.
That is an economic pressure on the supply chain. What happens is that pharmacist then goes looking for licensed wholesalers who might sell it cheaper so they don't lose money. What they end up running into are criminals who are selling counterfeits to licensed pharmacists who've managed to get themselves a wholesaler's license. Their counterfeits can be cheaper than the real product. Maybe they're smart and they only make it like $50 or $100 cheaper, but they end up taking advantage of those pharmacists. That's one of the areas where we're like, hmm, we've got to look at how PBMs and insurance companies are reimbursing pharmacies because that actually has an effect on whether or not we end up with counterfeits.
Giachino (04:45.0309 - 05:25.0850)
Along the lines of the economic factors and the economic pressure as well, I want to turn our attention to the impact that counterfeiting can have on innovation because it takes years and years of development for a drug to make it to market. It takes hundreds of thousands, if not millions and sometimes potentially billions of dollars, for a drug to make it through the process and make it to market. What impact do you believe that these counterfeit drugs are having on innovation and intellectual property rights?
Safdar (05:25.0890 - 06:52.0989)
There's no doubt that if you look at graphs of where the most innovative medicines are available, it's in the U.S. We actually pay for that privilege, but it is a privilege. If you want a frontline therapy, an anticoagulant therapy because you're at risk of stroke, the place you want to get it is in the U.S. because the newest product is going to be there first. Companies map out their entire value chain to make sure that they can make back the money that they have invested and make a return to fund all the other drugs that don't make it.
If you damage that value reward system in the first let’s say eight years when you were expecting to have an exclusive product on the market and it's going to make X amount of money to pay for all the other drugs that are going to fail, if someone comes in with some counterfeit and starts selling it to people and undercutting you, then you won't have money to find the next blockbuster drug. You won't have that extra revenue that allows you to buy and develop a small biopharmaceutical company that maybe would have made a huge patented breakthrough [on] a global blockbuster drug to help millions of people. It's not going to be there. The counterfeiters are basically robbing all of us of future lifesaving treatments, and that's just a horrible, horrible outcome.
Giachino (06:53.0230 - 07:29.0885)
That's a great way to describe that - robbing us. When I say us, I think that you and your colleagues and everyone who you work with through the Partnership for Safe Medicines, you do a really good job of laying out the role that each of us can play even as consumers in how we combat this counterfeiting. You talked about the role that insurance companies and PBMs, the Pharmacy Benefit Managers, may play in this. But what about us as consumers? What do you see as our role to help combat this counterfeiting?
Safdar (07:30.0325 - 09:12.0969)
We have a job to protect ourselves and the people around us. You and I may always go to a licensed brick and mortar pharmacy to get our medicines, in which case we're pretty safe. [It is] probably the safest place in the world to get medicine. But we all have friends and we all have parents, if they're still alive God-willing, we all have also aunts and uncles, there's people who look to us for advice and so we need to be educated about safe and unsafe ways to get medicine.
I still encounter on a regular basis, fellow parents, and I'm a parent of teenagers, who when I say they just busted this ring with a hundred pounds of fake pills with fentanyl that looked like oxy, but they had fentanyl and many of them would have been deadly, who look at me blankly like what are you talking about. So listen, you have an obligation as a parent to understand this risk, to talk about it with your kids and to make sure that you've got Narcan in the house.
Now that extends not just to the potential for kids experimenting with opioids that may turn into a fatal event, but also when your parent says, I'd like to save a little bit of money on this medicine and I was going to order it from this online pharmacy. You owe it to them to explain that just because it appears in Google search results doesn't mean they have a license from the State Board of Pharmacy. You can't tell, and neither can a pharmacist, a counterfeit blood thinner when you get it in the mail from a real one. The counterfeits are that good and so we all need to be a trusted source of information to our friends and family.
Giachino (09:13.0229 - 09:34.0039)
I think a very eye-opening part of your website that relates to what you were just talking about is the section that's devoted to how counterfeit drugs hurt real people. That's chilling. There have been so many lives that have been cut short. As difficult as it is, why are these important stories to be told?
Safdar (09:34.0309 - 10:43.0289)
I spent many years trying to convince people that counterfeit drugs existed. They just didn't believe it. Why would somebody make a counterfeit blood thinner? They will make a lot of money selling it. You will probably buy it. After I got to the point where people would believe me, they would say, but it's never killed anybody. I would say that's not true. But I had to document the stories. So the section of the website you talk about was a real concerted effort from the PSM research team to say we need to tell these stories. We need to tell the stories of these young adults or late teenagers whose lives were cut short by someone who made a perfect looking pill.
It's really important to make people understand that there's real consequences to that. So that was why we did that and it was actually just yesterday that the staff and I met together to talk about that section of the website. We agreed that it was important to leave it in place and not expire it even though we did that a number of years ago. But you have got to show that it's connected to real humans.
Giachino (10:43.0739 - 11:06.0320)
Making that connection as well, I think that we as consumers, we go online and pretty much anything is available now online. You think that you're going to a trusted source, even say something through the Canadian supply chain. But you've put up those warnings there. Is the Canadian drug supply safe for us?
Safdar (11:06.0479 - 12:31.0799)
It's not safe for us. It's safe for Canadians. Canadians have concerns about Americans taking their medicine because they actually deal with enormous drug shortages and don't have a lot of drug manufacturing in their country, nor do they have a lot of access to medicine. The way that it works in the world is that a manufacturer of medicines will not sell you an enormous amount in excess of what your population requires.
You cannot as Canada, with 1/9th of the population, buy the same amount of Ozempic as America, which has nine times the population. So they have an amount that has been scaled to their population. If Americans start ordering it, they will run out. They have run out. In British Columbia two years ago, the amount of Americans taking Ozempic out of British Columbia threatened to drain their entire supply in about two quarters. So halfway through the year they would have been out for their own people.
But that's not usually what Americans get. I'll be honest. If you go and you stand at a pharmacy in Canada, you'll get a safe medicine. If you go online and you try and find a Canadian pharmacy, you're likely going to get a pharmacy that will send you medicine that has only seen Canada from an airplane as it's trans-shipped to the U.S. to you. And that is the real danger. People don't understand that these companies will pretend to be Canadian and then send you something else.
Giachino (12:32.0090 - 13:36.0559)
Our guest is Shabbir Safdar. He is the Executive Director of the Partnership for Safe Medicines. It's an organization founded in 2003, a not-for-profit focused entirely on researching the danger of counterfeit drugs in America and educating the public about how to stay safe from them.
Shabbir also hosts “True Crime and Medicine Safety” and “Imitation Nation” covering all things counterfeit podcasts. As the host of your pharmaceutical crime podcast where you cover crime and raising the profile of these agencies that we expect to be going after these counterfeit criminals, you also talk a lot about policies, both current and proposed, that might ultimately increase or decrease the danger of these counterfeits that are making it into the American supply chain.
Along those lines, what do you think Congress specifically, and then maybe take it out a little bit further to some of the agencies, should be doing or not doing to help in this arena?
Safdar (13:36.0679 - 15:19.0431)
I think Congress's role at this point is probably to not break the secure supply chain. I think it's also to ensure that the enforcement authorities have what they need to ensure that criminals who are breaking the supply chain, that there's adequate resources to go after them.
I think there's also been a rise in patient safety issues around compounded medicine. Compounded medicine is not reviewed by the FDA for safety, quality or efficacy. I don't think a lot of Americans understand that. They just think it's cheaper. There's a lot of real issues with it. While it's an important safety valve for patients who need a unique formulation or to cover for a shortage, it's not meant to be the therapy you start on. It's supposed to be the last resort. I think there's probably some places where Congress could shore up some lax language in the rules around compounding that needs to be done.
I think agencies probably have an obligation to work together. We have an obligation, at least I feel like I do, to trumpet their work. The FDA's Office of Criminal Investigation just busted a website called Rat's Army that was selling research-grade chemicals to Americans to be injected. That's not legal, and it's definitely not safe. We need to make sure that when these law enforcement agencies take the bad guys out that we raise awareness about their activities. It's both a public safety education opportunity, but also an opportunity to make sure that our law enforcement partners have what they need to continue protecting us.
Giachino (15:20.0000 - 16:19.0543)
It was amazing as I was going through the Partnership for Safe Medicines’ website how frightening it is [how much] we don't understand. I was surprised to learn that compounded drugs do not go through FDA pre-market review for safety, as you mentioned. Now, I think you do a great job, and the organization does, of explaining the role that compounded drugs have, particularly when there are shortages, but in many instances that's not the case. They're just making their way into families' homes and again potentially costing lives.
Let me ask you this before I let you go because I appreciate so much the time that you've given us. One of the final questions that I always like to ask at the end of our discussion, and I'll just leave the mic open for you, is why should we care about IP protection, particularly in the realm in which you work regarding safe medicine?
Safdar (16:19.0682 - 18:10.0177)
I think that the innovation ecology of the U.S. is excellent. We don't make so many nuts and bolts anymore. What we make is intellectual property. Intellectual property is a new iPhone. That's one thing. But when it's an anticoagulant that will allow you to live a normal life and not have to spend a lot of time taking blood tests, being in a hospital or being monitored for that stroke, it's amazing.
I'll give you an example from my childhood. I'm 58 years old. I grew up through the AIDS crisis. As everybody of that era did, we all lost at least one friend to AIDS. At the time at the beginning of the crisis, a diagnosis was a death sentence once we actually understood how the disease worked. Today, because of innovation you can take a pill a day or a shot every three to six months and your HIV is so controlled that it cannot be detected on blood tests. That's how amazing innovation is.
Every time we do something to destroy the equation for innovation that involves risk and reward, we put that at peril. We put at peril the next one pill a day that controls your HIV. We put at peril the new anticoagulant that allows us to avoid strokes without a lot of medical monitoring. We put at risk the series of pills that you can take that are a cure for Hepatitis C, which is amazingly improved from the previous cure regimen.
I think that's why we have to really protect innovation in this country. We don't appreciate it until we don't have it and what the benefit is of having people who have the reward in place for making blockbuster drugs. Just how much better some of them are than the hospital treatments that we would take otherwise.
Giachino (18:10.0687 - 18:27.0219)
We appreciate all the work that you are doing and the work of the Partnership for Safe Medicines. To follow their work, go to safemedicines.org. Our guest has been Shabbir Safdar. Thank you so much again for your time today joining us on IP Protection Matters.