Inside China’s Stranglehold on the Global Medicine Supply Chain: Rosemary Gibson

[RUSH TRANSCRIPT BELOW] “The United States depends on China for 95 percent of the key components that are necessary to make our generic drugs, and if China shut the door on exports, within months, our health care system would begin to collapse.”

Rosemary Gibson is a national authority on health care policy and patient safety, and the author of “China Rx: Exposing the Risks of America’s Dependence on China for Medicine.”

“How come we don’t know that our medicines are being made in China? And this has been going on for a long time, and for years, there was actually zero regulation. How do we outsource production from a country with the highest standards in the world to places with no standards?” she asks.

In this episode, we dive into the realities of China’s control of America’s medical supply chain, the increasing problem of contaminated medications, and what the current administration can do to fix it.

Views expressed in this video are opinions of the host and the guest, and do not necessarily reflect the views of The Epoch Times.

RUSH TRANSCRIPT

Jan Jekielek:

Rosemary Gibson, it’s such a pleasure to have you back on American Thought Leaders.

Rosemary Gibson:

Jan, it’s great to be back. Thank you so much for having me.

Mr. Jekielek:

We interviewed almost five years ago. This was during the Covid pandemic, in the early days. You were talking about what this exposed in our supply chains of components of medicines, the threat that existed there. I was shocked. This was unbelievable information to me that we could be so vulnerable here in the West to China using these supply chains. Has anything changed? 

Ms. Gibson:

I remember when we met, Jan, as Washington and the country were shutting down. We talked about my book, China Rx, which exposed how dependent we are as a country on China for what we need to survive during a pandemic. The United States depends on China for 95% of the key components that are necessary to make our generic drugs. If China shut the door on exports, within months, our healthcare system would begin to collapse. 

That’s how dependent we are, and it’s not just us. The world is dependent. Europe is dependent. Because China has a chokehold on those upstream raw materials and chemicals needed to make these active ingredients, which makes the medicine medicine. That turns into the pills and vials that we have and take.

Mr. Jekielek:

I recall that about 91% of the prescribed medicines in the U.S. are actually these generics. So this is massive.

Ms. Gibson:

It’s huge. Whatever hospital you’re in, whether it’s all the big-name hospitals, what they use are generic drugs, and they’re about 90 to 91% of what’s administered and prescribed.

Mr. Jekielek:

While this may be obvious to some of our viewers, why is this a problem?

Ms. Gibson:

As ChinaRx predicted, a lot of what happened, in the event of a natural disaster, global pandemic, or geopolitical event, the United States will be waiting in line behind other countries to get vital medicines to save people’s lives. We have lost our industrial base. During the pandemic, we had rationing of vital medicines in this country. It wasn’t called rationing; that would scare the public. 

The media didn’t call it rationing. The euphemism used in the industry is, Dr. So-and-so, we won’t be able to deliver those drugs to you today. They’re on allocation, which means they’re actually allocating whatever they have in certain priority areas. So we were rationing drugs in the United States.

Mr. Jekielek:

Why? Spell that out for me. 

Ms. Gibson:

Because we have lost our industrial base to be able to make the medicines, 90% of our medicine supply. We can’t make it anymore. We can’t make antibiotics anymore in this country from beginning to end. We can’t make penicillin. We can’t make those antibiotics needed to treat sepsis, which can kill you. We can’t make antibiotics to treat pneumonia and sexually transmitted diseases. We offshored that. That’s a tremendous national security risk. 

If I may say, while we were very focused on treating viral infections, what about bacterial infections? During the pandemic in the early 1900s, what people died of was not viral infections, but bacterial infections. They died because we didn’t have antibiotics. If you remember, back in March 2020, China said that if the U.S. doesn’t do what we want, we could withhold antibiotics from the United States. Think of that.

Mr. Jekielek:

I remember when that happened, and I was thinking about our interview, because this was basically the case in point.

Ms. Gibson:

Absolutely right. We have a system that is perfectly designed for catastrophic failure and significant loss of human life. That has to change. And it’s fixable. This is a man-made problem.

Mr. Jekielek:

There’s basically two dimensions here of the problem, right? One is where they’re being made. We know a lot of them come from India, but we also know that a very significant portion of what’s made in India, those components come from China. So it’s really China.  

Ms. Gibson:

My book, ChinaRx, exposed that. This was a big shock to me. We all think of India, which is a great generic powerhouse. During the Covid pandemic, the Indian government actually came out and said that we depend on China for 69% of the components it needs for its industry. I can’t think of any other product, any other food commodity, whether it’s wheat, rice, corn, or energy supplies that we have allowed to be centralized in a single country, whatever country it is, it’s a disaster waiting to happen. 

Mr. Jekielek:

You’re giving me a 95% number; just explain to me how you got there. 

Ms. Gibson: 

First off, we’re talking about thousands of different raw materials and chemicals that are used to make our medicines, generic and branded drugs. The 95% figure comes from people who actually make medicines. They are pharmaceutical engineers and CEOs of companies. I’ll tell you a quick story. In February 2020, when a virus was coming from east to west and going to hit North America, I was having dinner with five extraordinary people who had a combined experience of 150 years in making medicine. 

I asked them this question as the entrée was being served, we’re going to need generic medicines to take care of very sick people in intensive care units and emergency rooms. What percentage of the components needed to make those medicines are sourced from China?  It was 90%, 95%, as we went around the table. That’s one data point from people who have to source from distributors. This is their business. It’s what they do. It’s like you’re a chef, and you know where all your ingredients come from and who are the best sources and the country of origin, often of where they’re made and produced. 

Another data point is a wonderfully respected leader in Europe who ran a company that supplied generics to our military. He said that about 98% of our generic drugs depend on some component from China. Another executive from Holland, now retired, said China owns that raw material market globally. And even the Europeans are concerned about what might happen if they decide to withdraw that? 

Mr. Jekielek:

Talking about this first dimension, which is where all of these things are coming from China, it’s hard to fathom that that could have ever happened. After that threat of withholding during the Covid pandemic, what has changed? We’ve been rushing to bring back those supply chains, repatriate them to America and the West, or friendshore as they call it. 

Ms. Gibson:

Overall, I think there’s been very little change. Companies have habits of how they purchase, and they want to purchase the cheapest product. We can talk more about this later and how that system works. But if you have a focus only on cheap and not on quality and value, it really gets you into trouble. Here’s how the antibiotic market lost its edge. 

China dumped penicillin raw material on the global market in the mid-2000s. “Dumped” means they sold it at a very low price with the intention of driving out U.S., European, and even Indian producers. At the end of the day, China became the dominant global supplier of penicillin material, and then they raised the price. 

So I think the reason that we’re not winning on this yet is because China has a strategy, and it knows exactly the pain points of each country in each region. If they see a move in one direction for an important product, they can say, well, we’re going to dump a product, lower the price, and that will deter Western manufacturers from getting back into the game. We don’t have a strategy like that. 

Mr. Jekielek:

Let me disqualify this: the strategy is not just commercial. 

Ms. Gibson:

This is an industrial strategy by a foreign government to remain dominant in this sector and, as it sees fit, to use that as leverage over any country that wants to get what it wants. 

Mr. Jekielek:

Quality is the other dimension. I had a trip to the Nutramax production facility. They make some very, very, mostly veterinary drugs but also a few things, veterinary supplements and supplements for humans, a few as well, some very interesting ones. One thing they told me, their chief of quality control told me, is they would get some large amount of precursor that would arrive or a large amount of components to make the supplement, right? They said they would notice they had a bar; it said it had to be 95% pure, but something would come and be 94% pure. 

What they discovered was that if they ever accepted that 94% purity when 95% was the benchmark, subsequent shipments would be even lower in terms of purity. They learned they had to ship back that entire ton or whatever large amount was so that people understood, no, that’s our benchmark. That was an astonishing realization. There’s a natural incentive to have these components come in, even if they are  from an enemy country. 

Ms. Gibson:

Another prediction in China Rx, is that the FDA would lose control over its ability to perform its regulatory functions and ensure a safe supply of medicines being sold in America.  And that’s exactly what’s happened. And the pace of that, the decline in what we’re seeing in terms of quality has just accelerated. If we don’t fix this now, we’re in deep trouble. 

It was fascinating to hear in March of 2023, the then FDA commissioner, Dr. Robert Califf, was testifying before House appropriations. It was budget season for the FDA, so these were the most candid comments from an FDA commissioner that I’ve ever heard, and I’ve been following this now for 11 years. He was very concerned about the agency’s ability to deal with the Chinese government and its manufacturers. He said the agency had been blocked from traveling to China to conduct on-site inspections of manufacturing facilities. 

That’s a very important part of the FDA’s regulatory oversight. They check to see if the building really exists, if that’s where the drugs are being made, and that they follow very strict good manufacturing practices. So the agency had been blocked from going. A second concern he raised is the lack of transparency and the lack of just being forthcoming. 

So if you’re a manufacturer here in the U.S., you provide a lot of information to the FDA about your product and your process, your quality control, and that’s part of the FDA’s due diligence. Dr. Califf said China is just not transparent. A third point that he raised was something that Congress had done, which was a good thing to do. Congress gave the FDA $10 million to conduct what’s called unannounced inspections. 

So imagine you have friends coming over for dinner. You say, I want you to come over on a Saturday night, you know, next Saturday night. You probably clean up your house a little bit and get things in order. That’s very different from your friends popping up, ringing the doorbell, saying, hey, we’re here for dinner. They get to see what your house is like in real life, day to day. 

So unannounced inspections are those where, and this happens every day in the United States, the FDA can come to your facility at 8:30 in the morning and say, we’re here. We’re going to be here for a week or two, and we’re going to take a really close look and conduct our inspection. Those are very, very rigorous. Unannounced inspections enable you to see in real time what’s happening. Those have not happened at all in China, which has refused them. 

So Congress spent this money, the FDA has tried, and Congress has wanted to see this accountability from the agency. But the agency can only do so much. It cannot act if a foreign government does not wish to respect our laws and our intent to protect the American public. So we’re at a crossroads here. The icing on the cake, or the nail in the coffin here, was four months later when China said, we have this new anti-espionage law. Under that law, foreign nationals who come to our country are at risk of being detained if we see whatever vague information you may be taking out of our country or doing whatever we think is not right. This would indeed be the job of the inspector to do precisely that. 

So imagine you’re an FDA inspector, a federal employee, and you have to travel thousands of miles to a country, and you’ve got to be really careful. So say you see some things that are not right, and you write up your report, and you have to give that report to the employees there and the CEO of the company. What if they don’t like what you’re saying? Because that report will be used as a basis if they find really serious problems to send a warning letter saying you’re in violation of our regulations. In the worst case, the FDA could ban the product, and you would lose money. So how would you feel as an employee coming up against that? 

Well, we got a really good picture of this. It’s not just the U.S. where this is happening. There was a very candid piece in the German trade press. They came out and said that they have their own drug regulators in Germany and other countries, counterparts to the FDA. They said, our people are afraid and don’t want to travel to China because they don’t want to be arrested. What was even more candid was that the pharma industry said, this is a big problem for us. 

This means these folks can’t go. We can’t have these facilities certified as being compliant with our high standards. We can’t get that certificate. That means we cannot sell those products from that facility in Germany. Think about that. Without a doubt, that is happening here in the United States. If FDA inspectors can’t go and the agency cannot perform its regulatory functions, we have nothing. 

Mr. Jekielek:

Shouldn’t that mean the product can’t come here?

Ms. Gibson:

That’s exactly right. So now we have to ask the question, how are these products coming here? How do they get into our marketplace? It turns out there are six U.S. companies that source 90% of the generic drugs that enter commerce, that end up in hospitals, that end up in retail pharmacies. They scour the earth looking for the cheapest price. 

They look to the FDA and say, the FDA will take care of us. We’ll hide behind their skirts. If they allow us to bring it in, then everything is fine. Even if it hasn’t been inspected in a few years, they can say, the FDA has said this is okay.

Mr. Jekielek:

The FDA hasn’t blocked it.

Ms. Gibson:

It’s really hard to block a whole company in advance. It takes a lot of effort to do that. If we did this across all the substandard drugs that are coming in, we would have shortages of tremendous numbers. So they can bring it into the United States because they focus only on price. I’ll give you an example of how this really works on the ground. 

There was a very ethical CEO of a generic company in the Midwest. A couple of years ago, he was describing how he was told by one of the reps from one of these companies, we’ll buy your product, but here’s the price we’re willing to pay you. By the way, this Midwest company had never had a product recall, never had a warning letter, and never had a bad inspection. The CEO said, I’m sorry, I can’t make a quality product at that price. Can’t do it. 

This is a microcosm of how we’ve lost our industrial base. So he later found out that this sourcing company had contracted with a manufacturer elsewhere that had a host of product recalls, FDA warning letters that said, “Hey, you’re violating our rules here, our regulations, and our law.” That is who this sourcing company contracted with. So there’s no incentive at all to bring value into the equation. It’s only on price. 

I watched the trade press over the years, Jan, and they would laugh that it’s hammer time for generic manufacturers. They would literally hammer down on the price paid to manufacturers. And if you hammer down too hard on anything, it’s going to break. Quality is broken. Our industrial base is broken, along with trust between doctors and patients. People are picking this up. They see that some of their generics don’t seem to be working right. I think we have an opportunity to reset this, and we can talk about some ideas to do that. 

Mr. Jekielek:

But before we go there, you mentioned substandard drugs coming in. How do we really know they’re substandard?

Ms. Gibson:

I’ve been interested in the idea of independent testing of generic drugs for some time, and I’ll tell you how that got started. I was invited out to the Cleveland Clinic to do grand rounds. And the topic was a root cause analysis of why there were really high levels of carcinogens in a widely used blood pressure medicine. This triggered a huge recall in the United States. No matter whether you’re a Supreme Court justice, in the White House, or Congress, you are probably taking medicine like Valsartan and other things. 

So I did the grand rounds at the clinic, and a very fine cardiologist had invited me. So we went back to his office afterward, and I noticed that on his shelf were these bottles of medicine. We’ve all seen them, the orange colored plastic bottles with the white cap. There were like 10 or 15 of them, and that was odd. I said, Dr. So-and-so, what are those? He said, I want to have those tested. I said, why is that? He said, because I think they’re not working right. 

This is a physician who, with his colleagues, takes care of patients with heart disease and actually some patients with very serious medical conditions that may require an organ transplant. He and his colleagues observed that some of the organ transplant patients, think of that, you’re having your heart taken out and you have a new heart put in. This is life-changing. He and his colleagues noticed that some of the patients would go home from the hospital and get their prescriptions refilled at a retail pharmacy. He said that things just didn’t seem right. The patients weren’t doing well. They were asking, is there something wrong with these generics that we are getting from these pharmacies? 

So they contracted with an independent laboratory to have them tested. The results were published in a medical journal, the Journal of Heart and Lung Transplantation. The data showed that the medicines were not dissolving properly in the body, which affects whether they work or not, and whether they protect you. This is a drug for preventing organ rejection, which is really important. 

So if you want to get into the technical details, what it means is if you’re taking a pill that’s for eight hours, if it doesn’t dissolve properly, you might be getting 40 or 50 percent of that drug in the first hour-and-a-half or two hours. You don’t have enough protection for the remaining six hours, and you could really get into trouble. And so these physician colleagues called up the FDA and asked, have you seen this? We’re really concerned about it, expecting this would be earth-shattering. But to their mind, nothing happened.

Mr. Jekielek:

In the FDA’s mind, nothing happened?

Ms. Gibson:

As far as we know, the FDA didn’t do anything. So a couple of years later, I met a very talented scientist, very dedicated and earnest. He had worked at the FDA for a number of years. He said, let me share with you some slides. There was a slide of the same drug. It’s called tacrolimus. He said that the same problems were found seven years prior in 2014, where it didn’t dissolve properly. So these are not unknown problems.

Mr. Jekielek:

Just to be clear, this isn’t that the entire batch of the drug isn’t working. It’s  just that some batches of the drug have this problem. In fact, that would be a lot harder to figure out. 

Ms. Gibson:

A lot of people know that if you get a generic, you’ll have multiple manufacturers of the drug, and you’ll get switched. So there were some generic manufacturers’ versions of this drug that didn’t seem to be working well. About two of these products were tested and found to have problems. And there may be some batch problems, because there can be inconsistency.

Mr. Jekielek:

But in this case, it would be the manufacturer. 

Ms. Gibson:

Correct, and the FDA has known about this. Actually, as you know, the Department of Defense [DOD] has started a generic drug testing program. And the same problems persist with the same drug. In the DOD pilot test, a very important drug for people with diabetes, metformin, has some of the manufacturer’s versions with levels of carcinogens that just shouldn’t be there. Again, this is not a new problem. The FDA has known about this for years, but nothing happens. 

I’m at the point now where I think we have to take a look at the companies that are bringing these products into the United States and putting them in interstate commerce and ask the question, “What do we do?” I think I’ve been watching with great care what Secretary Kennedy has been doing with the food industry. What if we brought together these six firms and said, it looks like we have some issues with the quality of generics. 

I think we need radical transparency on whether these are manufactured properly. What’s in them? We need good science conducted by ethical scientists, doing it in the public interest, and let the information speak for itself. I grew up reading Consumer Reports magazine. I would sit in my father’s chair, and there was a magazine rack on the side, and in there would be the monthly Consumer Reports. I loved seeing the red dot and the black dot for toasters and washing machines. That information really helped the marketplace. It gave buyers information to help make better decisions and also brought discipline to markets. I think radical transparency is part of that solution.

Now, if you think about it for a minute, why has the Department of Defense felt the need to conduct its own testing for a medicine supply? And not just them. A couple of years prior, Kaiser Health Plan, they were the first ones, and I admire that. They’ve also done the same thing. They require any company that wants to sell them generic drugs—certain products that they’ve chosen—to have their products tested. That tells you that they see that there’s something that’s not working for them. And how do we grow that? We need more of this independent testing.

At the same time, we can’t test our way through this. What we ultimately need is some domestic production of the finished drugs, of the active ingredients, of some of those starting materials. At least start somewhere to begin to bring this back. Because if we don’t fix this now, as you said, we’ll be on a downward slide, and we’ll be at the point of no return. I’m very concerned that we are reaching this point of no return. But I think we have an opportunity with the leadership in place now to begin to turn the corner here.

Mr. Jekielek:

This DOD testing has been going on for a while now and here are some preliminary results. What have they discovered?

Ms. Gibson:

There’s a diabetes drug, metformin, that has levels of carcinogens that you don’t want to have, and that’s in a few products. There are other products that are perfectly fine and test fine. The heart transplant drug or kidney transplant drug has issues of dissolution. So it may not be working right for everyone who takes it. Those are some early findings, and again, they’re consistent with what’s been happening and been observed in the marketplace. 

I think one of the really important points here, Jan, is that the opposition to doing this testing and maybe bringing some of these products back home are, it’ll cost too much. It turns out there’s absolutely no correlation between quality and price. So the DOD could be paying more money for a drug that you probably wouldn’t want to take from that particular manufacturer, and the better-performing drug actually costs less. The price and quality are not correlated, and that’s a big deal. So it doesn’t cost more, necessarily, to have good quality drugs. 

There was a wonderful pharmaceutical executive who’s highly respected in the field. He tells a story of how he had to go get a blood pressure medicine refilled, a three-month supply. He paid $157.50 for it. He asked me, how much do you think the manufacturer got paid? So I said $20. I had no idea. He said the manufacturer would be paid $1, and the rest of it, the $156.50, where does it go? 

To a point we discussed earlier, we need sort of a doge in here to figure out where all this money is going. But I don’t think it’s unaffordable at all for us to have quality products, including those produced in the United States that are cost-competitive. And what’s the price of quality, the price of the security of that pill that you’re taking? If you have a bad drug, people die. 

A Johns Hopkins-trained physician walked into the Mayo Clinic one night, into the emergency department, because he had some known problem that he self-diagnosed. It’s very common. It wasn’t a big deal. He was a healthy guy in his 40s. They said, why don’t you stay overnight? We’ll work you up tomorrow, and then you can drive back home, because he was a far distance from home. 

Within 24 hours, he was in multiple organ failure, and the doctors had no idea what was happening. The next week, his heart was removed and put on a machine. Three or four months later, he died a horrific death. It was traced back through multi-district litigation along with hundreds of other cases. It was a contaminated blood thinner. The API was made in China. It was a highly sophisticated fake substitute for the real active ingredient, and at high levels, it could cause death. 

So the implications of poorly performing drugs—things that are not made properly—are profound. By the way, the process by which this fake substitute was made, the Chinese government patented it, and it also flew under the radar of testing. Another point is that testing can get us only so far. Eventually, we have to have our medicines made by people who are trustworthy, ethical, and in places where the FDA can do its job and protect the public. 

By the way, it was President Kennedy who signed these amendments to the Food, Drug, and Cosmetic Act that laid out the legal framework for the FDA to have standards. What are the standards? They have to be pure. You can’t have contaminants in them. They have to work. And is the dose the right amount of, you know, is it really in that pill? 

This is a matter of our law. That was in the 1960s, and now as we’ve gone global, that’s all blown up. I don’t think we can blame the FDA for trying to manage an enormous global supply chain. We have generic drugs being made in South Africa, and as we know, India, China, everywhere. It’s an impossible task. So we’ve got to find a better way to manage it. But I do think we have a place to start in how we purchase these drugs and hold these companies accountable, not just for having them, but making them accountable for quality and not hiding behind the FDA.

Mr. Jekielek:

Let’s talk about this blood thinner for a moment. What was the motivation for inserting this fake component into the system?

Ms. Gibson:

Yes, there was a shortage of the real raw material. It comes from pigs, and China has a lot of pigs. There was a disease outbreak among the pig population, so they couldn’t produce enough product to meet market demand. Therefore, they came up with this fake substitute. Now, if you’re a legitimate company, what you do is tell the FDA what you’re doing. The FDA will ask you, “Well, how do you know it’s safe?” It has to be tested before you can just sell it and put it in a finished drug. So this was in response to a shortage of the real material. But that’s not the way to handle it by any stretch.

Mr. Jekielek:

What do you mean by a sophisticated action?

Ms. Gibson:

It matched so clearly. If you tested the fake substitute using the testing methods at the time, it wouldn’t have picked up the fact that this was in there. It wouldn’t have detected it. It was so out of the ordinary that those test methods would not pick it up. It was good enough for the Chinese government to patent it. They clearly wanted to do something with it. This was not from some rogue operators in a facility somewhere.

Mr. Jekielek:

But do they think that it worked?

Ms. Gibson:

It’s hard to know what the mindset was there. There were enterprising minds, and it’s good to have enterprising minds, but you want to put them to a purpose that serves humanity.

Mr. Jekielek:

Again, this is a situation where only some portion of that supply had this adulterated material.

Ms. Gibson:

That’s right. There were varying levels of it put into the finished drug. Some batches of the finished drug had higher levels than others. So it’s hard to pinpoint.

Mr. Jekielek:

 In its own words, the Chinese Communist Party is waging a people’s war against America. Between 80% to 98% of these components of medicines are from China and this is a very powerful potential vector of attack. If they put something bad into the supply, it would take a very long time for anyone to figure out that an attack had happened.

Ms. Gibson:

That’s exactly right. What’s happening with illegal fentanyl is playing around with the chemicals—illegal prescription drugs with fentanyl in them—so well done, the fakes, that it’s really hard to detect. What I’m concerned about is that we’re going to see a convergence of the illegal market and the legal supply chain and production of medicines coming from China. 

What does that mean? Those practices that are done in the illegal market that are killing people, what’s to stop enterprising minds, in a very negative way, who want to take down America from putting some debilitating chemicals into 2% or 5% of the most widely prescribed generic drugs in the United States?

Mr. Jekielek:

This is a very troubling picture. You’re saying there are no spot checks. People who could do spot checks feel like they could be arrested. They’re incentivized to give a perfect stamp of approval, because then they know they won’t have any problems. 80% to 98% of material is being sourced from there, with some components being sourced from there with nefarious intent such as fentanyl, which is actually a weapon of war from the perspective of the Chinese regime. This isn’t just a commercial issue.

Ms. Gibson:

I agree with that. I will call it for the first time. I believe that we will be seeing nefarious activity in our legal medicine supply chain that will be very difficult to detect. You could take down America without firing a shot. You don’t need any expensive missiles. You could debilitate the population and leave the infrastructure intact. If we don’t fix this—and we can fix it if we want—I predict that that’s where we’ll be. 

This is a perfect crime. You can harm people, even kill them. But how do you detect it? It’s very hard to detect when you put chemicals in, and these medicines are taken by people with different chronic illnesses. There’s already so much noise out there.

Mr. Jekielek:

There is so much complexity in the system, with all these different manufacturers.

Ms. Gibson:

Correct. And you know how the contaminated heparin was discovered? It wasn’t by the FDA. It was by a nurse in a dialysis unit at a children’s hospital in St. Louis. There were two kids on dialysis who were given heparin, and they got into trouble. It turned out fine for them, but it kept happening over subsequent weeks, despite their best efforts. Is it the water supply? What is it? Is it the air? That’s when the CDC and FDA were called in. 

But the signaling came from people on the ground, people taking care of patients. We have lots of carcinogens in blood pressure medication. The recalls I mentioned in 2018, three months after ChinaRx came out, were on cue. That was going on for six years before it was detected and was found by a company that eventually got that information to the FDA. We’re so behind the eight ball in terms of protecting this medical supply. It’s open season for anybody who wants to attack us.

Mr. Jekielek:

Going back to the DOD testing,  in the preliminary results, something like 10% of the supply was substandard.

Ms. Gibson:

Here’s what was tested. There were a number of generic drugs, and they each have different manufacturers, as we talked about earlier. So all those different manufacturers’ products are being tested. Say if you have five generic drugs and maybe ten manufacturers each, you’ve got 50 different products out there that you’re testing, and you’re testing multiple batches. 10% of what you’re testing is low quality. They have contaminants in them. They don’t work as they should. They lack efficacy. I started using the term “manufacturing defects.” 

The FDA’s term is adulteration because, in the FDA law, it says they have to be pure, they have to work, and many other things. But adulteration is hard to understand. If you look at it from a manufacturing perspective, 10% are, quote, low quality because of some of those problems. In my mind, that’s a manufacturing defect. I did a grok search on what constitutes a manufacturing defect, the 10%. This is bad. Imagine if the electronics industry had 10% manufacturing defects. If airplane parts had 10% manufacturing defects, that would be unthinkable. 

Now, to be fair, these are products coming from a lot of different countries; it’s not just one. But this level of manufacturing defects is so out of control, and we need to begin to fix it, because as you said earlier, it’s going to get worse. We’re going to be up to 12%, then 15%, and you’re beyond the point of no return, because people won’t even know what is good anymore.  

Mr. Jekielek:

If I may, 10% sounds massive to me. 

Ms. Gibson:

It is massive. These are drugs people are taking. It’s outrageous. I would use the analogy of having to go get new tires for the car. And if you go to Costco, I can’t imagine that Costco would have 10% of the tires that they would put on people’s cars to be defective. They could blow out while you’re going 60 miles an hour on Interstate 95. Well, the lawyers would handle that really quickly. Costco doesn’t want to have that reputation. So we have the marketplace that fixes that. We create some discipline. 

We don’t have that discipline now. It is anything that goes, and that’s what needs to stop. That’s why I really thought about the six companies that account for sourcing 90% of our generic drugs in this $100 billion market. And it can’t just be on the basis of looking for the cheapest thing possible. They have to stand behind the product now, and they can’t rely on the FDA, and begin to use radical transparency with data. So if some of these drugs are not working, well, who sourced that from that manufacturer? Let’s go find out.They should find out. And maybe they’re already doing something. I hope they are. 

But that’s the kind of conversation I could see happening in a meeting with these six CEOs and our senior leadership in Health and Human Services. And no more hand-wringing. They love to point fingers at each other. No, if you’re sourcing stuff and we have 10% manufacturing defects, this is on you. What can we do to help you solve this problem?

Mr. Jekielek:

Couldn’t you create competition? Do these six companies all work together? I’m confused by this. Why doesn’t one of them want to have a hundred percent good product?

Ms. Gibson:

I think we need a burning platform. Remember when Ralph Nader was advocating for auto safety? At that time, there was the Ford Pinto that was not safe. It shouldn’t have been on the marketplace. He said it was because of the designed-in defects of the vehicle. He was absolutely right, and by the way, the industry hated him. Lee Iacocca from Chrysler said, maybe we have something here. Could safety be a competitive advantage for us? 

And so it began. You didn’t need rules and all of that, but safety became something that consumers wanted. But it did start with a burning platform, and there was a law putting in seat belts and other safety features. So I agree with that. But I think we first have to know that we have a problem, and a very serious problem. And you don’t want to scare people. 

Think about it. You’re on a gurney going into an operating room for major surgery, or you have an infection that could lead to sepsis, and you’re scared to death because it can kill you. We don’t want to frighten people too much, but we have to do enough to put it out there to say we have to fix this. And I think we have an opportunity now to do it, doing exactly what we’re doing in the food industry to raise awareness. 

I’ll tell you, I was on X, and there’s a mother I follow who has a child with an organ transplant. And she put out a post saying that, well, a lot of moms are concerned about a particular transplant drug. And so I responded, and I said, is it this tacrolimus drug, this one that’s had perennial problems? And she said, yes. So this is an issue that’s just under the surface that people experience in their lives. 

There’s no place to take it and there’s no outlet for it. I think we have the opportunity to change that. It’s all about making America healthy again. If you can avoid these medicines, absolutely, let’s eat better and exercise. But if you have to take them, they should be right and nothing less, because people are betting their lives on it. 

Mr. Jekielek:

So there’s this first dimension, which is the quality, and fixing that will also solve the second dimension, right? Fixing the quality requires repatriating.

Ms. Gibson:

Absolutely. 

Mr. Jekielek:

It requires, you know, very rigorous testing. It requires—and you’ll have to explain to me how this will happen—making sure that the scientists doing the testing are ethical and rigorous themselves, right? Because there’s, let’s just say, there’s a lot more doubt in the scientists and the physicians since the Covid pandemic, right?

Ms. Gibson:

Yes, we need to have trust in science. We need ethical people that are willing to have a conversation about their data and how we’re approaching. And let’s develop a responsible community of practice that isn’t conflicted, that doesn’t take money from industry. We’ve got to start somewhere. And this is a continual dynamic. You start out as a mission, then it becomes business, and then a racket. That does happen. But can we at least start somewhere and have a track record.

If you’re a testing entity that’s calling it out and the company said, yes, this is true, and they fixed it, that to me is a really good track record, and what we want to see is improvement in the quality of these products. If people were smart, they’d want to do that. That will create a weeding out of those, I’ll call them the bottom feeders, that don’t want to play by the rules. 

Mr. Jekielek:

Among these thousands of components for medicines that come from communist China, there are some that we could start producing almost immediately here in the US. There are others that would take quite some time to ramp up for production. Is anyone even looking at that?  

Ms. Gibson:

There certainly are people thinking about what we should be producing here that are these key starting materials, the raw materials and chemicals. But I think you have to build up to—I think it would help to build up demand for the finished drugs and APIs manufactured here, particularly the active ingredients, which makes the medicine. Start with that. 

Then you’ll be wondering, how can we make more of that here? So once we can make more of the active ingredients here, that will automatically trigger, let’s bring some of these key starting materials to make these particular APIs for really important drugs that are lifesavers. That’s where the conversation will happen.

Mr. Jekielek:

For a poor quality product, it would seem obvious.

Ms. Gibson:

It’ll be really great to see how that turns out and the impact on the market. It’s been very interesting to hear that so far. You know, the pharmaceutical industry has always been against tariffs, particularly when it comes to China. So we’ll see how this plays out.

Mr. Jekielek:

One of the things we’ve been talking about a lot on this show is conflicts of interest and the problems those create. So maybe if I could get you just to tell me what conflicts you might have, if there are any, and also just a little bit about your background and how you got into this.

Ms. Gibson:

Sure. How I got into this, it goes back actually more than 20 years. The first book I wrote was on errors in medicine, medical mistakes. That came on the heels of what was then called the Institute of Medicine at the National Academy of Sciences. They wrote a very courageous report with a number of 98,000 people dying every year from medical mistakes. I saw that and I said, I want to put a human face on that. 

My book, Wall of Silence, told the story of people who suffered from medical mistakes and physician and nurse perspectives. The intent was to break open this wall of silence. That was so transformative in my career and just listening to people. I remember there was a woman who was an anchor on a television station, and she had to have plastic surgery because that’s just what it does at that stage of her career. And she suffered terribly. There was an error, and she was in excruciating pain, lost everything. And she said, there’ll be so many of us that it will blacken the skies. 

The next book I did was on overtreatment in medicine, The Treatment Trap. There’s too many surgeries being performed, too many medicines being prescribed. What impact does it have on the user, the everyday user? I remember there was a gentleman during an interview; he called in a radio show, and he said he went into a hospital for an eye problem in one eye, and he came out blind in both eyes. So these things so much moved me and motivated me to work on safety and quality issues in my other professional life. 

With China Rx, I started this work in 2014 just because I stumbled on this issue. How come we don’t know that our medicines are being made in China? And this has been going on for a long time. For years, there was actually zero regulation. How do we outsource production from a country with the highest standards in the world to places with no standards? How do we let that happen? Then Congress passed some laws, and we got something going. 

I did this work and no one paid me to do it. I’ve been doing it for 11 years. Because if you see something, you have to say something, and you have to do something. There’s a guy who said to me, I can bet there’ll be people to pay you not to do this. I said, that could very well be true. So all the proceeds from China Rx we donate to good causes, including girls’ education. We do this work in the public interest and don’t represent any special interest. 

I will say that after China Rx came out, there was work to try to bring some manufacturing back home, and there was a group of people that got together and said, well, we want to start this company, and so I was asked to be on the board of that company. It’s doing it in the public interest for purposes of national security and health security because we have to be part of the solution.

Mr. Jekielek:

What does your company do?

Ms. Gibson:

It’s a company that I’m on the board of. They’re making essential generics. Here’s what I said in testimony in 2019, Congress, because we need solutions. I recommended that we have a public-private partnership to make essential generic medicines using advanced manufacturing. And this idea was not mine. I’d been reading about advanced manufacturing, but I happened to meet people. And they said, well, maybe we could do this. And that sounded really interesting. And that’s what this is. 

It’s incredible that it happened. I’m not a lobbyist. I don’t hang around on Capitol Hill. That’s what happened. And we need a lot of this across this country. We need 50 of these, all making products that people can trust. Because it’s all about trust. Because people are on that gurney betting that that pill, that vial, is going to be made right for them and everybody else every day, 365 days a year. They’re betting their lives on it.

Mr. Jekielek:

Rosemary Gibson, it’s such a pleasure to have you on the show.

Ms. Gibson:

It’s great to be here, Jan. Thank you so much.