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Guest Host: Maria Hinojosa
American doctors and hospitals have been dealing with drug shortages for the past decade. Shortages of chemotherapy and other cancer-fighting agents have been particularly frequent. And when the cancer patients are children, it’s especially difficult for their doctors. They have to make tough decisions about who gets potentially life-saving drugs and who does not. A group of pediatric cancer specialists just released guidelines on allocating scarce medications. We discuss what’s behind the drug shortfalls and what government regulators, the pharmaceutical industry and hospitals say needs to be done.
- Dr. Yoram Unguru Oncologist, Children's Hospital at Sinai in Baltimore; faculty member at the Berman Institute of Bioethics, Johns Hopkins University
- Capt. Valerie Jensen Associate director, Drug Shortage Staff, U.S. Food and Drug Administration.
- Dr. Sheri Fink Medical doctor; correspondent, The New York Times; author of "Five Days at Memorial: Life and Death in a Storm-Ravaged Hospital"
- Joseph Famulare Chairman, the International Society for Pharmaceutical Engineering; vice president, compliance and external relations in pharma technical quality at Genentech; former FDA compliance official
MS. MARIA HINOJOSAAnd thank you for joining us. I'm Maria Hinojosa of NPR's Latino USA sitting in for Diane Rehm. And what an honor it is to be here. Good morning, everyone. Now, more than 150 drugs are in short supply in the United States. Shortages of chemotherapy and related cancer-fighting agents have been notably frequent. Is this the new normal for sick Americans? On Friday, a group of children's cancer specialists issued ethical guidelines on how to better best decide who gets scarce life-saving drugs.
MS. MARIA HINOJOSAJoining me in the studio to talk about allocating these drugs is Dr. Yoram Unguru from the Children's Hospital at Sinai in Baltimore and Johns Hopkins University, Capt. Valerie Jensen of the Food and Drug Administration and Joseph Famulare of Genentech and the International Society from Pharmaceutical Engineering and from a studio in New York City, Dr. Sheri Fink of The New York Times.
MS. MARIA HINOJOSAAnd we're going to take your calls throughout our program, but welcome to all of my guests.
DR. YORAM UNGURUThank you. Great to be here.
CAPT. VALERIE JENSENThank you.
MR. JOSEPH FAMULAREThank you.
HINOJOSAOur call -- place to call us is 1-800-433-8850. Our email is firstname.lastname@example.org. You can also find us on Facebook and Twitter. And we're gonna start with you, Dr. Sheri Fink in New York. You wrote a pretty amazing piece in the New York Times recently. It was pretty emotional, but give our listeners and overview of what you discovered when you dove deep into reporting on drug shortages. You, in fact, were the one who put into print, "is this becoming the new normal in American medicine." Dr. Sheri Fink.
DR. SHERI FINKThanks. Well, yes, I put that into print because I actually started reporting on this in the year 2012 when I was working on my book "Five Days At Memorial" and the story came out in the New York Times on Friday at the same times that the publication by Dr. Unguru's group came out. And people can find it on NYTimes.com. But what I heard, since 2012, was doctors, nurses, pharmacists all across the country using those words to say, we are dealing with an increase in shortages that seems to not be going away.
DR. SHERI FINKIt is becoming the new normal and there have been a number of stories over the years about this issue and what's causing it and what some of the solutions are, but what I was interested in is what is happening? What is happening to our health care? And it turns out that drugs are being rationed. They're being saved for some people, for some uses, and you know, in other cases, not being used. It's ad hoc. It's different all over the place and there are ethical issues, value judgments as well as medical questions that come to bear when there are shortages.
HINOJOSASheri, can you just describe for us, 'cause, yes, you've written a book, you wrote this long piece in the New York Times, but what was the thing that kind of impacted you not as a medical doctor, per se, but actually just as a human being in your reporting? Is there one moment that you want to tell us about?
FINKYeah. It was -- I'll tell you about two moments. One was being at the Cleveland Clinic which is one of the medical centers that's been really proactive on this. And they said, you know, I mean, it's amazing. They said, come on in. Spend time with us and see how we're dealing with this. See how we're making these decisions. And two things came out of that. One was just hearing how agonizing some of these decisions are. I mean, in some cases, it's a child versus an adult, whose going to get the standard of care and who's going to get an alternative care that we don't know as much about.
FINKSometimes it's even based on weight. There was one drug that was found to be ineffective at preventing infections in surgical patients who are obese, unless it's given at three times the normal dose. And that hospital and other hospitals didn't go up to that dose that the obese people needed until after the shortage of that drug, (word?) was over. So you can be rationed based on weight, on child versus adult. But perhaps the most impactful was talking to actual patients. And I remember visiting a patient at her home.
FINKHer name was Bev Smith. She's a Crohn's Disease patient. She has not -- she's not able, like most people, to absorb food that she eats so she relies on intravenous nutrition. And she suddenly developed a terrible rash and she didn't know what it was about and turns out that they had withheld zinc, you know, one of the elements and this was a classic sign of zinc deficiency and here was another layer, which is should doctors, should pharmacists tell patients when a shortage affects their care.
FINKShe said I had no idea. Why didn't anybody tell me? So these were some of the moments that really stuck out for me over the years of reporting on this.
HINOJOSAAnd for those of you listening, Dr. Sheri Fink's article and Dr. Unguru's paper are on our website, drshow.org. And I want to bring you in, Dr. Unguru. Why are the cancer drug shortages particularly frequent?
UNGURUWell, the drugs that are in short supply, it's important to appreciate, specifically is chemotherapeutics, but it's not just chemotherapeutics. And I'll answer your question in a second, but I think it's important for your listeners to appreciate that it's not just being a cancer patient or an oncologist that's you're impacting. These drugs include chemotherapeutics, antibiotics, critical care drugs so you're going to be impacted no matter who you are. But when it comes to the chemotherapeutics, a lot of the drugs that are in short supply belong to this class of what we call sterile, generic injectables.
UNGURUAnd for a variety of reasons, especially when it comes to children with cancer, these are the particular drugs that we depend upon. In fact, they make up life-saving regimens not just for adults, but mainly kids with cancer. And many of these drugs we rely upon and there's not alternatives and that's why we're seeing so many of these shortages impact kids in particular.
HINOJOSACaptain Valerie Jensen with the U.S. Food and Drug Administration, when we hear -- the doctor said, you're going to be impacted, no matter who you are. This is not because you're a cancer patient. No matter who you are, you can be impacted by these drug shortages. I'm sure that some of our listeners, they're jaws are dropping and just saying, hold on. Drug shortages as this point? What's your response to that?
JENSENWell, FDA takes this serious problem just -- we take it just very critically. We know that this is impacting patients. We hear from patients, we hear from physicians and as Dr. Unguru said, these older sterile injectables, they've been, unfortunately, very prone to shortages in recent years and we really saw a large spike in shortages in 2011, 2012 where we really saw many of the drugs that were mentioned in the New York Times article in shortage, which were oncology drugs, anesthesia drugs and also antibiotics and IV nutrition drugs.
JENSENAnd so these were horrible shortages and FDA continues to take every step that we can take, but it's really a manufacturing quality problem that's lead to most of these shortages so that's something we're really trying to work closely with industry to address because we know that's the root of this problem.
HINOJOSAA manufacturing -- you said a manufacturing and what?
JENSENQuality. So these are...
HINOJOSAManufacturing and quality issue. Joseph Famulare, you are the chairman of the International Society for Pharmaceutical Engineering. Your organization did a broad survey on drug shortage. So what do you say is causing these drug shortages?
FAMULAREIndeed, as Dr. Jensen said, the majority of the issues in the study even that FDA did attributed the issue to manufacturing and quality problems.
HINOJOSACan you be -- I'm sure that people are listening and they're saying, manufacturing and quality problems. I'm not really understanding what exactly that means if I or my child needs that medicine.
FAMULAREPharmaceuticals, especially steriles, as one pointed out, are made to very exacting standards, very high technology. And as some of these older drugs, some of the factories that were needed, some of the capacities that were needed diminished over times, there were some actions taken that involved removal of some products due to defects, et cetera, from the marketplace, et cetera. So in order to recognize that, firstly, ISPE conducted an in-depth survey to find out what were some of the major root causes in terms of facilities and equipments.
FAMULAREAnd basically, looked at that and basically now has started on a drug shortage prevention plan, bringing together all the various facets of industry, those that build the plants, manufacture equipment that are used to manufacture products, actually, and the actual manufacturers to focus on life cycle management of products to maintain their quality and proper supply over the life cycle of these products.
HINOJOSACaptain Valerie Jensen, how can be that in the United States we can't produce an adequate supply of potentially life-saving drugs that have already been approved and are already on the market? How can it be that in the country that we believed is the most technologically advanced, that somehow there is a glitch? And what is the proper role of the federal government? And then, I'd like to actually like to hear from you, Dr. Unguru.
JENSENWell, most of these shortages that were really critical, and these are the cancer drug shortages, the IV nutrition drug shortages and some of the others, those were due to large manufacturers that had these ongoing quality problems that suddenly really ballooned into something even worse and they ended up shutting down. And as Dr. Famulare mentioned, it's been particulate issues, so particles in vials as well as sterility problems. So these are things that are really serious that could cause harm for patients.
JENSENSo when the firm shut down to address the problems, there really weren't any other manufacturers. There were only a few manufacturers making most of these drugs. So if one shuts down the capacity or the available manufacturing lines just are not in enough -- there's not enough supply to meet all patient needs.
HINOJOSAAnd we're having a conversation about drug shortages in the United States and we're going to continue our conversation in just a moment, after this break.
HINOJOSAWelcome back. I'm Maria Hinojosa, executive producer and host of NPR's Latino USA sitting in for Diane Rehm today. And we're talking about drug shortages in our country. We're joined in the studio by Dr. Yoram Unguru who is an oncologist at Children's Hospital at Sinai in Baltimore. And Dr. -- nope, not doctor, Joseph Famulare who is not a doctor. He is the chairman of the International Society for Pharmaceutical Engineering.
HINOJOSAAnd Capt. Valerie Jensen who is with the U.S. Drug -- Food and Drug Administration and on the phone from New York, Dr. Sheri Fink, who's a medical doctor and a correspondent for the New York Times and author of "Five Days In Memorial: Live and Death in a Storm Ravaged Hospital." Dr. Unguru, you wanted to jump into the response about what the role of the federal government should be.
UNGURUThere's no question that the shortages are, for many reasons, a complicated problem. And we were speaking, before the break, about the manufacturing and quality control issues and that is a problem. Very few companies produce many of these drugs and as Capt. Jensen stated, when there is a problem with one of the production lines, it takes a long time to compensate for that. And these shortages aren't new. You can go back to the 1920s, shortages of insulin, 1940s, shortages of penicillin.
HINOJOSABut people think that was in the past, that that was not modern necessarily, evolved -- technically involved country.
UNGURUAnd over the past 10 years, though, you've seen more and more of these shortages and specifically with these chemotherapeutics. And I think we wouldn't be doing justice if we didn't allude to the fact that it's not just manufacturing and quality. There's economic drivers here as well. That is hugely, hugely important and there's a variety of reasons for that. And keep in mind that this is primarily our problem here in the United States.
UNGURUThere are shortages that happen outside the United States, but they do not involve nearly the same degree in terms of number of drugs or last as long. And that's a huge policy point that needs to be addressed.
HINOJOSAWhich I think brings probably no comfort to any patient who needs the help that the fact that this is a problem that we are facing very specifically in the United States. Dr. Sheri Fink in New York, let's talk about the issue of money. As I was prepping for this over the weekend and I brought this issue up to just people, you know, regular people, they said it's a money thing and this is about money and it's pharmaceuticals and they want to make money regardless of whether or not they had actually read into that.
HINOJOSAThat was their initial response. And you write that one of the reasons for the shortages is that some pharmaceutical companies are abandoning low profit products. So how much is money a part of this conversation?
FINKWhat I've heard is that sometimes when some of these quality issues that were just discussed come up and a manufacturer has to shut down a line, make some improvements in order to meet those important safety and regulatory standards, that sometimes they say, well, you know, it's not economically feasible for us. And we have to remember, these drug companies are for-profit companies and they exist to make a profit. That's how the system works.
FINKSo you talked about a federal role. I remember during -- as I was reporting on this, we had shortages, amazingly, of salt water. This is saline solution, sterile saline that is used, as everybody knows, so widely for IVs to hydrate people, for many, many drugs that need to be diluted. And at that time, there was some discussion, you know, can the government, quote, "march in" and actually compel a company to make a product that is vitally important? So that's been discussed. We can hear perhaps from the FDA on whether that's feasible.
FINKThere have even been lawsuits. There was a shortage of a drug for a rare genetic illness called Fabre Disease and at that time, the rationing that occurred was that children still got their normal dose. Adults got a, I think it was, a third of the dose. And there was a man who died. His family sued the drug company, didn't go anywhere. But so there has been a lot of thought about how could we address this in some unusual ways.
HINOJOSAAll right. So Capt. Jensen, why can't the federal government just tell the drug companies that they have to manufacture an adequate supply of a life-saving drug that's already on the market? Why can't the federal government do that? I'm imagining a patient saying, why can't the federal government protect me?
JENSENRight. That's -- I mean, we would love to be able to tell a company how much to make and what to make, but it's just not in our authority. But what we can do and where we've made progress is really where companies are required now, after 2012, there was a new law that was initiated where companies are required to tell FDA when they're going to have any type of shortage. And before that, we wouldn't find out about a shortage until the patient didn't have the medicine at the pharmacy.
JENSENSo now, with this new law, what's helped is companies are coming to us early on and we can work with them and we can take the steps that we can take, that FDA is able to take to help companies make more supply and meet needs. And I can go through some of those steps, but...
HINOJOSAWell, actually, Dr. Sheri Fink, what's your response to what Capt. Jensen just said?
FINKWell, it certainly -- my reporting backs it up. The number of new shortages has dropped. The number of existing shortages, however, has continued to remain high so it does seem like -- and I've heard the FDA has taken other steps, has allowed for importing drugs that may be, say, approved in Europe. But when there's a critical shortage here, sometimes the FDA has allowed for that to happen. So these are all steps. Certainly, they're very aware of the issue. Dr. Jensen has worked for years on it as well.
FINKBut it's still a problem and, you know, after my story ran on Friday in the New York Times, I've received more, you know, input from doctors and patients. There are still current shortages that are very troublesome.
UNGURUWhat Sheri said is really important. I just want to reiterate. The number of new shortages in 2015 was 142. That's lower and that's due to the work by Capt. Jensen and industry and others. The number of existing shortages or acting shortages at the end of the year was 185. Our inability to resolve...
HINOJOSASo we're talking about 185 plus 142.
UNGURUNo, no. We're talking about there were new drugs that became short and then there was those new drugs plus older drugs that remain short so we're having a hard time resolving existing shortages. But to draw back to the question that was brought up about the economic drivers, so we are one of the few countries out there that doesn't negotiate drug prices with companies and companies can make up their margins based on their negotiations with other countries here in the United States.
UNGURUAnd oftentimes, the statement is made, we leave pricing up to market competition among pharmaceutical companies and that's true and that's well and good, but now it comes back to that issue of a consolidated marketplace. If you only have one or two companies that make many of these life-saving drugs, there is not competition and they can charge whatever they want. And this, again, goes back to this point of this is our problem here in the United States.
HINOJOSAAnd Joseph Famulare, what's your response to that? Do we just need more companies at this point?
FAMULAREWell, I think, as we're seeing in this conversation, the problem is multifactorial. And so firstly, to Val Jensen's point, I think what you see now is earlier recognition and communication with FDA when a shortage may and will occur based on not only the law being put in place, but strong outreach and cooperation efforts put out by FDA to measure and address shortages and to work with FDA and industry to mitigate those shortages.
FAMULAREBut going forward in terms of the economics, and I'm not on the economic side, I'm on the technical side and regulatory side of this business, but what we do see in International Society for Pharmaceutical Engineering is that there needs to be a multifaceted approach from quality, business continuity, building capability in order to prevent shortages. So we have to go from reacting to them to preventing shortages. And that means also technological solutions where they have to -- medicines that are common such as saline, et cetera, have to be produced efficiently and effectively, more agility in manufacturing and more modern manufacturing processes to handle this efficiency.
FAMULAREAnd certainly, FDA has been with industry promoting this and that's the next step of our drug shortage prevention plans that we've been working on.
HINOJOSADr. Sheri Fink, you know, when you've been reporting on this now for years and you hear this, we've got to do this, we've got to do this, is there an actual -- you said it's gotten better, but I think most Americans would like to hear that there are no drug shortages in our country. Is that unrealistic?
FINKWell, I mean, that would be a great goal or certainly only in a very rare and catastrophic scenario. So I think that perhaps a greater knowledge of how these issues are affecting actual patients, how they are causing doctors, like Dr. Unguru and many others who I spoke with, to feel themselves put into an untenable ethical situation where they're having to literally choose which groups of patients, sometimes even what individual patients, get the drugs, that perhaps wider knowledge that this is happening, which is often been happening kind of silently behind the scenes without informing patients, maybe there will be more of a public outcry for more innovative solutions, you know.
FINKLike has just been discussed, there have been many things that have been brought to bear on this problem in recent years, but it hasn't solved the problem completely. So it seems like there needs to be more attention to it.
HINOJOSAI want to just read a couple of emails that we got. An email from Ray in Marcellus, New York, says, "why aren't the pharmaceutical companies being incentivized to produce more critical drugs known to be in short supply?" And email from Hunter in Austin, Texas, says, "are these shortages due to Obamacare rationing?" And on the website, a comment, "Republicans tell us that competitive markets solve all of these supply problems. Maybe somewhere along the yellow brick road, capitalism needs some help from society to find a brain and a heart, plus the courage to do the right thing."
HINOJOSAAnybody want to jump in before we go to break? Dr. Unguru.
UNGURUWell, I think that the callers, the writers all make valid points. I don't think that this is due to any one particular problem. It's a very complicated process. I do think that -- and therefore, capitalism isn't the only answer and Obamacare isn't the only answer, nor is it -- I don't think it's the problem. Again, these shortages have existed well before President Obama was elected. In fact, as Captain Jensen pointed out, the FDA safety and innovation act that President Obama signed into effect in 2012 has made some positive measures to deal with these shortages.
UNGURUBut I can tell you that as a pediatric oncologist, somebody who takes care of kids with cancer and their parents, having to make these decisions is not something that I enjoy doing and is very, very fraught with, as Sheri pointed out, ethical undertones.
HINOJOSAAnd we want to talk about the difficult ethical decisions that this drug shortage is bringing up in our country and decisions that doctors are having to make on a daily and maybe not even letting patients know about them. We're joined in our studio by Dr. Yoram Unguru, he's an oncologist and a member of the -- faculty member at Johns Hopkins University. Joseph Famulare is with the International Society For Pharmaceutical Engineering.
HINOJOSACaptain Valerie Jensen is with the Food and Drug Administration. Dr. Sheri Fink is with the New York Times. And my name is Maria Hinojosa. I'm executive producer and host of NPR's Latino USA and you're listening to "The Diane Rehm Show." If you'd like to join us, call 1-800-433-8850 or send an email to email@example.com. You can also find us on Facebook or tweet at us. So I'm gonna take a call now. We're gonna listen to Janice in Toledo, Ohio. Janice.
JANICEThank you for taking my call.
JANICEI am a bladder cancer patient. I am also a nurse. I have been involved in getting treating with a drug called BCG, which is a biologic like the people on your show have been talking about. I have talked to the CDC. I have talked to the FDA. I have talked to my legislators from the state of Ohio. I have talked to the company, the assistant to the medical director of the company that makes this drug currently. Nobody has any answers. With all my research, the only thing that is making any sense to me is that the pharmaceutical company that can afford to advertise ad nauseum during the 6 o'clock news will not put money into this plant to improve the problems with manufacturing and to produce more. I find...
HINOJOSAJanice, thank you so much for that. Actually, I wanted to ask you a question. Is she still with us? Janice?
HINOJOSACan you just, because you're dealing with this now in this moment in your life, just very briefly, the emotions, the emotional rollercoaster, if that's what it is.
JANICEThat's where I was gonna go next. Because I'm a nurse, I've got some background and because this drug is scheduled, I know when it's available and when it's not available. The physician will say, it's not available. That's what happened with my first course that I had here in Toledo. The drug wasn't available. So you start to think, number one, I'm not getting the drug, my cancer's gonna get worse. Number two, what about the other people that are coming into the office that are getting their treatment delayed?
JANICENumber three, do I get it and they don't get it? The ethical dilemma put upon the patient by this problem is unbelievable and it's...
HINOJOSAThank you, Janice. Thank you so much, Janice. The ethics of -- you know, and I'm thinking right now, actually, of a best friend of mine who just passed away, may she rest in peace. And I'm like, oh, my god. Maybe one of the reasons why her cancer was so aggressive is because there was some sort of shortage and we didn't even know about it. Her husband happens to be an investigative journalist. And it's like, wow, could that have contributed? Am I wrong to think that, Dr. Unguru?
UNGURUNo, you're not wrong at all. And Janice, I'm very sorry to hear about your experience and your friend as well, Maria. But we have to understand, these are thousands of Janices out there. Data from doctors, both medical, meaning adult oncologists, pediatric oncologists, they haven't been able to prescribe their preferred chemotherapeutic. There have been delays in therapy. Sorry to tell you, Mr. Jones. You have cancer X. We can't treat you, just as Janice described because we're missing a drug.
UNGURUIt's impacted clinical care. It's impacted research. So the ethical issues here -- and we know that doctors lack guidance. Now, the ultimate solution to this problem isn't our framework on how to allocate. The ultimate solution is to prevent his and there has to be some broad-based national policy to prevent this or should actually be some national advisory statement we feel on how to allocate. What we're doing is putting a finger in the dike. In the meantime, until that happens and it has to happen, how do you go about making the decisions?
UNGURUAnd what our recommendations focus on are specifically kids with cancer and we give very concrete guidance on how to guide that and I'm happy to go into that if you'd like, but I'm sure there are some more general things you may be interested in.
HINOJOSAWe want to talk about that and the ethics of having to make these very difficult decisions, especially when it involves children. We're gonna continue our conversation on drug shortages in just a little bit. And we want to hear from you, Captain Valerie Jensen. When Dr. Unguru says we need to do something now, you say...
JENSENWell, we agree. We do need to do everything that we can do to address these problems. And as Dr. Unguru said, prevention is really key. So if we can have the early communication from manufacturers where it gives us, as an agency, as FDA, time to react and to work with other companies to hopefully fill the gap, that takes some times, but it's something that we routinely do. So if we get the notification from a company that they're going to be in short supply, we do everything possible to avert that shortage.
HINOJOSAWe'll be right back with our conversation.
HINOJOSAWelcome back everyone. I'm Maria Hinojosa, executive producer and host of NPR's Latino USA. And you are listening to "The Diane Rehm Show." And I'm so happy to be sitting in for her today, as we're discussing drug shortages in the United States. I'm joined by Dr. Yoram Unguru, who is an oncologist at Children's Hospital in -- at Sinai, in Baltimore. Joseph Famulare is the chairman of the International Society for Pharmaceutical Engineering.
HINOJOSACapt. Valerie Jensen is with the U.S. Food and Drug Administration. And Dr. Sheri Fink is a medical doctor and a correspondent for the New York Times. And you can find Dr. Sheri Fink's New York Times article and Dr. Unguru's paper on allocating scarce drugs and the ISP's Drug Shortages Summit report all on the website at drshow.org. I want to talk for a second, before we go to our calls, about ethics.
HINOJOSAAnd I want to bring you in, Dr. Sheri Fink. The ethics -- we're not gonna talk yet about the ethics of making a decision about who gets the drugs and who don't. This is the ethics about people even knowing that they might be experienced a drug -- experiencing a drug shortage and they're not sure. They're a patient and they think everything's going forward. Is there a rule and what are the ethics on informing patients?
FINKSo this is a big question that was raised in the Times article that you referred to. And I spoke with ethicists, including Dr. Unguru and others, and also looked at the research. And it was interesting -- and spoke with doctors about how do you decide whether to tell somebody. Many of them said we don't tell them. We don't want them to worry or we think we have a pretty good substitute drug so we're not going to mention it.
FINKParticularly in the drugs with anesthesia. So that's when you go to sleep, when you're having a surgery. The anesthesiologist generally would not tell patients. And many, many anesthesia drugs have been affected. So interestingly there was a study that just was published last year, where an anesthesiologist, Dr., H-S-I-A, is how he spells his name, Ivan -- went to hundreds of patients at the Mayo Clinic, two of their locations and in Canada.
FINKAnd he asked them would you want to know if there was a drug shortage for effecting elective surgery, maybe a minor difference in side effects between the preferred drug that you can't get and the alternative drug. He was shocked to find the vast majority of patients said we would want to know. And in some editorials related to that publication the response was, gee, we should start telling our patients. The ethics of this are clear.
FINKAnd I asked that doctor, so have you changed your practice. And he said, you know what, I haven't yet because it's hard to figure out how to explain this to patients, this idea of relative risk, of how much more risk you might be at with an unfamiliar drug. Your doctor's using an unfamiliar drug might not get the dose right. There have been studies showing the impact of these shortages on medication errors, you know, increased side effects, other things. So he's still struggling with that question of do we tell our patients, when do we tell them, how do we tell them.
HINOJOSAAnd, Capt. Valerie Jensen, with the Food and Drug Administration, are you guys talking about these ethical questions?
JENSENWell, we do hear from physicians, from pharmacists that they have to make these very difficult decisions. And we believe that's, you know, it's really something that should not have to happen. Again, that's something that, you know, we believe we really need to work closely with companies so that we can prevent these shortages before they occur.
UNGURUSheri's 100 percent right. Patients need, not only to be told, they need to be part of the decision makers in how these processes about how one allocates or prioritizes happen. In our guidance we're very clear that they need to be members of that panel. And it shouldn't be the decision of an individual doctor. That's not something, a burden, anybody should be able to handle on their own. This really takes a lot of stakeholders to be involved, patients, patient advocates, doctors, pharmacists, industry, FDA, journalists, etcetera.
UNGURUBut to go to one of the points that Sheri raised about the problem with alternatives. Even when we have an alternative, there's no data, necessarily, especially in pediatric oncology and taking care of kids with cancer on its efficacy. There was a very poignant study that was published a few years ago in the New England Journal by Metzger and colleagues, where children with a type of lymphoma, Hodgkin's lymphoma, there was a shortage of a drug called mechlorethamine.
UNGURUIt's been around forever. And an alternative drug was substituted because it was short. So the kids and the adolescents who got the alternative arm had more rates of relapse of their disease, progression of their disease and so they go exposed to additional rounds of toxic chemotherapy, even bone marrow transplantation. And so now put yourself in the position, well, I didn't want to tell the patient, the kid and the kid's parents, 'cause I didn't know. And now you have to kind of clean up after yourself.
UNGURUAnd it's very hard to do that. And so we need to be honest. We need to be forthright. It's okay to say to a patient, I don't know how this is gonna turn out. Too often we feel like we have to have all the answers. Now, we should be able to come up with some mechanism, but these discussions need to happen.
HINOJOSAI want to bring in Kerry, from Houston, Texas, who is a caller who is also a former Marine. Kerry, are you there?
KERRYYes, ma'am. Thank you for accepting my call.
HINOJOSAHi, Kerry. Go ahead.
KERRYJust a quick question. Does the government have a facility where they manufacture drugs or do they purchase commercially in a private sector? And a Desert Storm veteran, I remember when they shipped out new Anthrax pills for take. When there's a shortage in the commercial sector, is there a shortage for the military? And last question, if a hospital wants to stockpile these drugs, especially the lifesaving critical cancer drugs, what's the shelf life on that? And I'll…
HINOJOSAAnd who wants to jump in?
JENSENI can start. So there is not any -- the government does have the authority to manufacture drugs. We don't have any facility. The drug supply for the U.S. is coming from commercial manufacturers. And so that's where the military is getting their drugs, as well. So that, you know, it could affect military supplies, as well, when there's a shortage.
UNGURUAnd I'm happy to follow up on one of the comments about the stockpiling. So that's one potential solution to this, that we stockpile critical care drugs. Now, we many not all necessarily agree. For example, if you're a cardiologist you may think that there's a cardiac drug that's critical. I'm an oncologist, but we'd probably reach some consensus. But the more interesting point here is this notion of hoarding.
UNGURUSo it's natural, right? There was a snow storm here in the Baltimore/Washington area last week. And what's natural? You go to the store and you buy toilet paper, batteries, coffee, whatever. Hospitals do the same thing. And there's data. 85 percent of hospitals purchase excess inventory in response to shortages. And so you could be lucky enough to show up to a hospital that has excess drug, and you'll have that drug for your availability.
UNGURUBut if you're not fortunate, and you just show up to a hospital that didn't have it. And so this is, I think, something that's interesting for industry. And there's a role there. Maybe they can serve as a gatekeeper and help us figure out, oh, this hospital suddenly is ordering 20 times more than what they typically need. It's something to think about.
FAMULAREIf I could comment on that from the industry perspective. Firstly, for industry is very empathetic to the needs of patients and all production planning and scheduled is really based on delivering quality supply to patients. And the fact that there are gaps in that is still the area why industry is working as a consortium under ISPE to resolve that. Because there's certainly empathy for the patients who need that.
FAMULAREBut in terms of being predictive and planful, just stockpiling alone is only one facet of it. And the other aspect of it is got to start with obtaining ingredients, reliable supplies, understanding what are your critical and sole-source drugs, where possible, go to duel sourcing because if one manufacturing facility has an issue, is there another source? Manufacturers use both their internal capacity, as sponsors and license holders of the medicines, but they also use contract manufacturing organizations.
HINOJOSAAnd the people who are making these decisions are hospital administrators, for example. Right? 'Cause these are not doctors?
FAMULARERight. In terms of the purchasing and supply, if there's a known shortage, as Val Jensen said, we work with FDA. And when it comes to those allegations, then we could work closely with FDA.
HINOJOSADr. Sheri Fink, in New York, jump in.
FINKI just wanted to mention -- so I said at the start that I started looking into this issue when I was writing this book, "Five Days at Memorial," which was about a disaster and about rationing health care during Hurricane Katrina. But the interesting thing is that some of the federal disaster response experts, including Dr. Nicole Lurie, who's quoted in the article on Friday, in the New York Times, is that they see the analogy between a disaster situation and an emergency situation and these drug shortages.
FINKIn fact, a couple years ago Dr. Lurie and others from academia wrote a book called -- sorry, wrote an article in the New England Journal called "Rationing Saltwater." And they argued that we, Americans, should look at these drug shortages as a form of a disaster, as a form of an emergency. And I do know that that part of the federal government under HHS, Health and Human Services, is looking at exactly what you asked about at the start of this segment, could we have some manufacturing capabilities within the government or that the government supports, let's say.
FINKAnd I do understand that they have worked on -- one of the issues in particular that's caused a lot of shortages is just the fill and finish of a drug or, you know, caps that go onto vials. So I think that there has been some intention…
HINOJOSASo the drug is there? The drug is there. There's just a finishing part that's missing?
FINKYes. And so there's a -- I believe our government is trying to encourage or support additional manufacturing capacity under some of those types of, you know, types of steps in the manufacturing. Somebody else in jump in here if you know more on the…
HINOJOSANo. I guess for me…
FINK…manufacturing side, but that could help with that, provide some national capacity in an emergency to help with that.
HINOJOSADr. Sheri Fink, thank you for that. Okay. So now I'm actually saying, okay. So it's not just about the medicines? It's about something finishing, a cap? Dr. Unguru?
UNGURUWell, that I'm not aware of. I can't speak to that, but what I do want to follow up on Sheri's point is this is a natural emergency, a natural disaster. And as a result of that there needs to be appropriate steps to deal with it. The government stepped in to bail out the insurance companies. The government stepped out to bail out the auto industry. Why not help in some regard when it comes to drug shortages? Again, I want to paint the picture, which I think every -- we heard from Janice earlier. We heard about your own question that you had about your friend. I can tell you that when you're taking care of sick kids, sick adults for that matter, this is an untenable situation. It cannot continue.
HINOJOSAFrom the government's perspective, Captain?
JENSENYeah, I know there are several different initiatives being looked at. But I know one thing that we as FDA can do very quickly, and as quickly as possible when there is one of these shortages that's affecting patients, is if we get early notice from the manufacturer, which is now required, we're able to work with other companies. And so for IV saline, the saltwater that Sheri mentioned, that was a horrible shortage. Every single patient that goes into the hospital needs IV saltwater, they need IV saline.
JENSENSo we had to take unusual steps and import. So we brought product, IV saline, in from three different countries overseas to help patient needs. And we'll continue to do that. We've had to -- unfortunately, we've had to do that 22 times over the past few years. And we'll continue that. It's something that we feel very strongly about being able to do.
HINOJOSAAnd you're listening to "The Diane Rehm Show." My name is Maria Hinojosa and we'll be back in just a second. We want to continue our conversation now. And I think we want to bring in a caller. Actually, this is Ron, from San Antonio, Texas. Ron, are you there?
RONYes, ma'am, I am.
HINOJOSAGo ahead, Ron.
RONThank you for taking my question. It's a really simple one. We have a United States surgeon general. And I'm thinking about -- well, here I'm showing my age. Sometime back, C. Everett Koop ran lots of public service announcements promoting an opinion that he had trying to rally the people. Where's our surgeon general? Why isn't he out here talking about this and getting the people to get their Congress to do something?
HINOJOSAI think that…
RONThat's basically the question.
HINOJOSAThank you so much, Ron. I think that probably a lot of people are feeling the same way. Like, you know, when the surgeon general speaks about one thing, everybody kind of listens. And I can't recall the surgeon general saying this is something that you need to pay attention to. Why not, Captain?
JENSENWell, I'm in the public health service, so I report to the surgeon general. And I can tell you it's a critical issue for all of us. And so it's something that, you know, we do take very seriously. We are, in government, doing everything that we can currently do to work with companies. And we've made some progress, as you've heard. But we know we have a long way to go and we'll continue to do everything we can do.
UNGURUSo I want to point out that I think Capt. Jensen and the FDA are doing yeoman's work. I don't want it to come off as though I'm bashing them. They're in the unenviable position of doing something that they never were meant to do. Their task, typically, was making sure the drugs are safe and effective. And now they find themselves monitoring these drug shortages and coming up with solutions. And they're doing a good job at that. But there is certainly -- and the caller eluded to this -- a sense of complacency. Sheri stated this new normal. We shouldn't tolerate that. And I think that's the difference.
HINOJOSAI want to read an email that we got from Mike, in Jacksonville. He says, "I'm a 20-plus-year hospital pharmacist. For about four to five years now we have had a weekly meeting to discuss drug shortages. People might think it's the expensive drugs that are in short supply, but actually it's the cheaper, older drugs that are most affected. Drug companies just quit making them because their margins were not as big as they would like." Again, the question of profits. So older drugs, cheaper, just not the big ca-ching value. You're shaking your head, yes.
UNGURUIt's not the big ca-ching. It is the older, sterile, general injectables. And there's a lot of reasons for this. In 2003 a government act was passed with took effect in 2005 for reimbursement of how Medicare paid for these sterile, generic injectables based on a formula called average sales price plus 6 percent. It's very cheap to -- they were getting very little reimbursement. So from a pharmaceutical company's perspective they may not have a lot of investment on their return -- a lot of return on their investment so they may not want to continue to make them.
UNGURUThis is one of the points that is exactly showing the complexity of this. But it's not the big-bang drug that is in short supply. Those aren't a problem. Those are continuing drugs for hepatitis C, $100,000 a year for one patient for melanoma, $150,000 to treat one patient for one year, cystic fibrosis, $300,000 to treat one patient for one year. It's the drugs like etoposide, which is a chemotherapeutic that's been around since the '60s and '70s, methotrexate, since the '50s, that go for very small margins that are in short supply. And these are the drugs that cure kids with cancer. Cure them.
HINOJOSAAnd, Joseph Famulare, you say -- you're with the International Society for Pharmaceutical Engineering. You say that your organization puts the patient and the empathy front and center. How does that compare with what we just heard from Dr. Unguru?
FAMULARECertainly, the ability to supply is front and center and empathetic to the companies and the individual members that make up ISPE. However, the problem of quality manufacturing and technology we realize is, while a big piece of the puzzle, the larger -- there are larger market forces, insurance, etcetera that have affect that. To really cause attention on this, we have partnered now with the Pew Research Institute, to quickly put together a study on all those business factors, supply chain issues, etcetera, and to publish that this year, to further dig into what may be causing even more holistically this multifactorial problem.1
HINOJOSADr. Sheri Fink, you are a journalist, you're a writer, you're also a medical doctor. Some thoughts that you'd like to leave, just in the 30 seconds we have left, with the people who are listening.
FINKI do think that the public has a role here. I think one of the important things is that this has been largely hidden from the general public, from all of us who could be affected by it. So go out there, learn more about it, and if this is a priority for us as a nation, we've managed to surmount other large problems that have complex causes. It's not a reason to give up. It's a reason to focus harder on it.
HINOJOSAI want to thank everyone for joining me in the studio for this conversation. Dr. Yoram Unguru, Joseph Famulare, Capt. Valerie Jensen, and Dr. Sheri Fink in New York. I'm Maria Hinojosa of NPR's Latina USA, sitting in for Diane Rehm. Thank you so much for listening. Have a great day.
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