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Critical chemotherapy drug shortage in Michigan sparks concern

Dr. Salim Siddiqui, President of Michigan State Medical Society speaking at a MSMS event
Dr. Salim Siddiqui, President of Michigan State Medical Society speaking at a MSMS event


Cathy Shafran: This is 89.1 WEMU. I'm Cathy Shafran. We've been hearing about drug shortages for some time now. Over the past year, we've seen shortages in everything from antibiotics to medications for attention deficit hyperactivity disorder, inhalers. Even children's Tylenol and ibuprofen have been hard to find at times. But the drug shortages are now reaching critical stages. Michigan hospitals and those across the U.S. are reporting the shortage of cancer drugs, and they are now having to use alternatives, possibly less effective drugs for cancer patients. Joining us to help understand the impact of these shortages is Dr. Salim Siddiqui, both a specialist in radiation oncology at Henry Ford Health in Michigan, Medical Director of the northwest region of Henry Ford's Health Cancer and also president of the Michigan State Medical Society.

Dr. Salim Siddiqui: Thank you for the time. We're talking about the shortage of cisplatin and carboplatin. These are core drugs for many common cancers. For example, non-small cell lung cancer, head and neck cancers, many gynecological cancers, for example, cervical cancer, ovarian cancer, individual cancer, testicular cancer, bladder cancer, and even pediatric cancer. These drugs are the backbone of many of the standard of care lifesaving cancer treatments that we use in our clinics today. The way these drugs work is they go in to the cancer cell, and they damage the DNA, the blueprint the cancer cell uses to grow and spread.

Cathy Shafran:So, when there is shortages, what happens for the patient?

Dr. Salim Siddiqui: Every cancer doctor and every cancer care team that's facing this shortage is trying to develop alternative treatment plans.

Cathy Shafran: Have you had a personal experience with this where you've had to tell a patient, "Unfortunately, we don't have the medication that we would typically use?"

Dr. Salim Siddiqui: Just last week, Thursday, I had a patient who expressed some concern regarding a message he had gotten that maybe some of the medication was not going to be available, that for his standard of care, carboplatin, taxol, chemotherapy. And I had to reassure him that not just myself, but the entire cancer team was working to not only obtain supplies of these medications, but certainly to develop alternatives.

Cathy Shafran: What eventually happened with that patient? Was he given a different medication, or is he just not using it at all?

Dr. Salim Siddiqui: Well, I know that he completed that last cycle. It's going to be a question of what happens for the last two infusions in his care. And, right now, the team is working on that plan.

Cathy Shafran: How did we get to this point?

Dr. Salim Siddiqui: If you dig into this, this is something that we have heard rumors of for well over a decade. And when I say rumors, I'm talking about the drug shortages, not just these two critical chemotherapy drugs, but I believe right now there's 200 plus or 300 drugs that are on the active drug shortage list, according to the American Society of Health System Pharmacists. So, how did we get here? And when one tries to answer that, we start looking at the the generic drug space. And you realize how broken that space is. It is a multi-factorial problem impacted by the economics of generic drug manufacturing, the supply chain challenges, the lack of transparency within the supply chain. And then, you know, I think the national security aspect of it is the fact that we rely on many foreign providers for active pharmaceutical ingredients and some of the starter agents materials to make these drugs. And when you bring all those elements together, the compounding effect is what we're experiencing now: one piece of that chain breaks or we're unaware of it because of the lack of transparency. And then before we know it, we find ourselves in this kind of a critical crisis.

Cathy Shafran: When did this latest round become critical? Like, when did it strike you or strike others that this is a critical shortage?

Dr. Salim Siddiqui: I'll tell you. I honestly, and this is probably my optimistic naivete, when I first heard about it, this was Platte Park. It was in February of 2023. And I honestly thought when I didn't hear anything else happening, and we had addressed the problem. And then, I heard carboplatin had started to run behind.. Gosh, that was less than a month ago. And I was like, "Huh, that's concerning." And the reason it struck me that that was concerning was I already knew colleagues had switched pharmacists to carbo for some cases. So then, it struck me that, "Holy moly! Maybe we still don't have enough of cisplatin, and they're switching to carbo. And now we're running out of carbonplatin." So last week, when we set up our incident command center here, just like we did during the pandemic to manage the acute dynamic nature, that's when it hit me, Cathy. Oh my goodness, this problem is still going on! And that's when it really kind of struck home. And we're sounding all the alarms and getting everyone engaged to help address this at all levels. So, in the clinic, all the way through this year, most leadership across state medical societies and national organizations to help address this.

Cathy Shafran: The chemotherapy drugs that we were talking about. Are they manufactured in the U.S.?

Dr. Salim Siddiqui: This is the other part of the problem. There's only a handful at most for many of these drugs. There's one or two, maybe three manufacturers. So, a handful at most. And many of those manufacturers are foreign. If there's a problem with quality, if they don't meet our standards, or if there's a problem with quality, the plant goes offline, you lose that supply. And for an indefinite amount of time, the way the current process works. If a plant goes down because of a quality issue, it's got to be inspected and then recertified by the FDA before they can resume manufacturing, which makes sense. We want to have high-quality, safe products. But if that process is not robust, if it's not timely, then we end up with a short supply and a shortage.

Cathy Shafran: I see that there's an ongoing, immediate effort to make the public aware. I see the press releases, and I'm hearing it in all the media right now, that needs awareness. But are you guys doing something at the same time in addition to awareness?

Dr. Salim Siddiqui: So, I know that our our leadership is reaching out to our state senators. I know that there was a meeting in March, I believe of this year, on the the Homeland Security and Government Affairs Committee hearing regarding the drug shortages. I know that there was a meeting, more recently, in the oversight and investigation subcommittee. I think the first thing we need to do is assess what is our supply right now--assisting cargo. Where is it? Who are the manufacturers who are able to produce this? In other words, if there's someone whose line is down, we consider shifting the starting materials and the active pharmaceutical ingredients to that manufacturer who has a line up and running, who also meets our quality and safety standards. We shift to them as we figure out who has the capacity to manufacture this now, get them the starting materials and start dealing with the shortage while, in parallel, we address what is our manufacturing capacity of this. You know? And are we optimally using that manufacturing capacity? I think there's more regulatory steps that have to happen. Well then, we streamline that. We expedite that. We get that part done. I think that's the next step is how much drug do we have, not just nationwide but globally? Who is able to produce it? Let's get them the starting materials. Let's get this addressed. We need to have more transparency. We need to understand the supply chain better from the moment of dose, starting materials and the APIs, the active pharmaceutical ingredients, all the way through delivery to the patients.

Cathy Shafran: Are you also reaching out to manufacturers? Is that part of the plan as well?

Dr. Salim Siddiqui: Reaching out to manufacturers and officials is happening. But, again, it's very hard when you reach out and the feedback you get is, well, there's manufacturing delays, or, you know, you get feedback that there is increased demand, or, you know, you get no clear reason. So, we are doing that, but we need to be able to have a more immediate solution, while the manufacturers are working on their challenges on their side. One thing that may help is to create some kind of incentive system to help manufacturers to ramp up production to alleviate some of these scarcities. And then, maybe we can look at communicating any of the shortages, again, using the FDA's Office of Drug Shortages to communicate with them, to get them the information, so that we're collaborating between the state and the federal level. And it reminds me, sitting particularly in Detroit, in Michigan, we think of the national security implications of a shortage like this during another threat to our national security: World War II. We were part of the arsenal of democracy, and we used our collective American industrial might and innovative spirit to save the world. I would hope that, during this time, we can mobilize that same might, that same spirit of innovation to solve this problem and hopefully not have to deal with these challenges in the future.

Cathy Shafran: Dr. Salim Siddiqui, medical director of Northwest Region, Henry Ford's Health Cancer and also president of Michigan State Medical Society. I want to thank you so much for joining us and addressing this issue. And our hopes are that there will be changes in the future in a positive way. Thank you for joining us.

Dr. Salim Siddiqui: Thank you, Cathy. Thank you for the time.

Cathy Shafran: I'm Cathy Shafran. This is 89.1 WEMU-FM, Ypsilanti.

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Cathy Shafran was WEMU's afternoon news anchor and local host during WEMU's broadcast of NPR's All Things Considered.