NEAL CONAN, Host:
This is TALK OF THE NATION. I'm Neal Conan in Washington. Susan Kennedy was halfway through her chemotherapy treatment when her oncologist told her that one of the key drugs in her regimen might no longer be available. Susan Kennedy joins us now from her office in Red Bank, New Jersey, nice to have you with us today.
SUSAN KENNEDY: Thank you for having me.
CONAN: And when did you find out this medicine might not be there?
KENNEDY: I found out sometime in about mid-July. I was more than halfway through my treatment. Needless to say, I was quite shocked.
CONAN: Because you're obviously supposed to finish the treatment, and timing on the delivery of the medication is critical.
KENNEDY: It is critical, not only the timing, but the specific drugs that I was taking was really my only option. I mean, when you're diagnosed with cancer, there's so much uncertainty, but the one thing I knew was that this was the drug that would help me survive, and there were no substitutes for me.
CONAN: And your oncologist, what, called you the night before?
KENNEDY: Yes, actually he sent me an email that - just to give me a heads up, and after a sleepless night, I went in, and we talked about it. And, you know, I found it pretty hard to believe. It really was incredible.
CONAN: There was, it turns out, a national shortage.
KENNEDY: Yes, I had no idea until that moment, but after that, I went back and did some research and found out, you know, this was happening all over the country.
CONAN: And you went to therapy. Was it there?
KENNEDY: I did. The way the - my oncologist explained it to me was he and his colleagues had to sit down and have kind of a triage meeting and figure out - they set forth a very strict protocol of who would get the drugs, and then they had to follow that protocol, and it was really based on who needed the drug to survive, you know, who were the people who were extending their lives by a couple of years, who were the people that could tolerate or would be helped by an alternative drug.
And then they applied that criteria, and luckily, based on that criteria, I was one of the ones that got the drug in question.
CONAN: You got it, but by implication, others did not.
KENNEDY: Exactly. So you're - you know, you're experiencing emotional turmoil at that place, at that point. At first you're very relieved, but they you realize, you look around the room, at all the people you see every week when you go to get chemotherapy, and you say gosh, if I'm getting the drug, who isn't.
And that's a pretty tough burden to bear.
CONAN: I understand your treatment wound up last month. How are you doing?
KENNEDY: I'm doing fine. I'm doing fine. I'm feeling much better. I have - I'm having surgery the day after tomorrow, followed by radiation, and then I just hope to get back to being myself.
CONAN: Well, good luck to you, thank you very much.
KENNEDY: Thank you very much.
CONAN: Susan Kennedy, a lawyer in New Jersey. She joined us from her office in Red Bank. She wrote a piece about her experience in USA Today. You can find a link to that at our website. Go to npr.org. Click on TALK OF THE NATION.
Drug shortages have been on the rise in recent months. Over 200 medications are in low supply or have already run out. Doctors, pharmacists and drug companies have to make those difficult decisions about who gets medication and who doesn't.
If you've been affected by a drug shortage, call and tell us about your experience. The phone number, 800-989-8255. Email us, talk@npr.org. You can also join the conversation on our website. Go to npr.org. Click on TALK OF THE NATION.
Later in the program, the political junkie joins us a day early as Chris Christie chooses Trenton over D.C., but first NPR health and science correspondent Richard Knox joins us from his home in Massachusetts. And you may have heard his report on drug shortages yesterday on MORNING EDITION. Now, Richard, nice to have you back.
RICHARD KNOX: Thank you.
CONAN: And this shortage, not just about cancer drugs.
KNOX: No, in fact a lot of the reports over the past few months, actually, have been about cancer chemotherapy because it's such a wrenching situation. And oncologists and cancer specialists have been increasingly upset about it.
But when I began looking into it, I was struck that it really is a very broad cross-section of drugs. It's important to note that these are not the drugs, the prescription drugs that you go to the pharmacy and pick up, you know, a bottle of pills.
These are drugs that are used every day in hospitals. They're so-called sterile injectables. They're IV or injection drugs. Sometimes they're used, as in Susan's case, in an outpatient basis to give chemotherapy for cancer, and sometimes they're used for things like intravenous feeding for people who need it, and they're not in the hospital. But largely, they're hospital drugs.
CONAN: So not tetracycline but some of the more exotic drugs used in hospitals for patients with specific conditions. but as I understand it, the number of drugs on the shortage list was around 70 a few years ago, and it's now 200.
KNOX: Yeah, they've counted so far 213 this year, and we still have, you know, a quarter of the year to go. That's considerably more than last year, and it's really accelerated since about 2007. I looked at the FDA's shortage list today. There are around three dozen drugs on it at the moment, and they include a lot of cancer drugs like (unintelligible) and 5-FU and Taxol. These are very common cancer drugs.
Antivirals, antibiotic injectables, streptomycin, norepinephrine, which is used every day in hospitals to raise blood pressure in critically ill patients. So it's just a wide range of drugs.
CONAN: And do we know if this has cost people their lives?
KNOX: It probably has, and people say that it has. The Associated Press tried to do an account from various sources and published a story last week that said - that found 15 deaths. Certainly the people I talked to say that there undoubtedly have been and will be deaths. It's hard to count. A lot of people don't want to talk about this. There's no, you know, required reporting of this kind of thing.
Hospitals don't like to talk, I've found. I mean, basically they don't want to tell people we can't give you what we need. Many patients do not know, I think, that they have been the victim of a drug shortage because hospitals and doctors do workarounds. They use other drugs and substitute other things in combinations and don't necessarily tell you we couldn't get the first-line drug for you.
CONAN: And, well, Susan Kennedy described it as the doctors in her oncologist office did this triage. They decided which patients absolutely needed this particular drug that she was taking and which could - might be able to use alternatives. This goes by another name, it's called rationing.
KNOX: It's called rationing. I mean, it's right here. I mean, people always think rationing is something that doesn't happen in American medicine, which is so expensive and really the best in the world. And it is in many ways, but it is certainly happening not only at the doctor level, but companies are rationing.
In the case of Doxil, which is the drug that Susan needed, the company has a waiting list, and it put out a letter on September 23rd saying not everybody on that waiting list is going to get the drug.
CONAN: So why is it that manufacturers can't simply ramp up production to meet demand?
KNOX: Well, it's - a lot of people think it's because there's not enough money to be made in these, and we might want to come back to that question. It's more complicated than that. But basically there are really very few companies these days in America making these so-called sterile injectables. Only about seven companies, according to the FDA, produce most of them.
And so when one company has a glitch in the manufacturing process - I mean, there can be some contamination with some particles or something - they have to shut down the line and correct that, and of course they should, but then there's either no other supplier, maybe two or three other suppliers of that drug, and they can't ramp up production fast enough to meet the demand is what I'm told.
CONAN: We want to hear from those of you who have had exp with drug shortages, 800-989-8255. Email us, talk@npr.org. Let's start with Linda(ph), and Linda's on the line with us from Ohio.
LINDA: Hi, Neal, thanks for having me on.
CONAN: Sure, go ahead.
LINDA: I just wanted to say that I'm a registered respiratory therapist, and I assist in the intubation of patients who are unable to breathe and need to be put on a ventilator on an emergency basis. The most common drug we use for that is Propofal, Michael Jackson's experience notwithstanding. And there have been times recently when our pharmacy has not been able to provide us with Propofal. We have to use less effective alternatives, and if people are in need of emergency intubation, sometimes we do it without knocking them out, which is hard on people.
CONAN: Intubation, literally putting a tube down somebody's throat to help them breathe.
LINDA: Yes, that's correct, in order to keep the airway secure and cause them to breathe mechanically.
CONAN: And this is obviously in a critical situation. What's the difference between the drug you would like to use and the drug you are forced to use?
LINDA: Well, the alternative that we often use is Versed, which is also a type of benzodiazepine that you would take in tablet form. We use it intravenously. Versed doesn't clear the system as quickly. It doesn't do what we call as clean a recovery as Propofal, and also its onset is slower.
I can knock you out in a matter of 30 seconds or so with an intravenous dose of Propofal. It might take several minutes more than that with Versed. And of course, if you can't breathe, you don't have very long before bad effects begin to occur.
CONAN: And have you seen any disastrous effects because of this?
LINDA: I wouldn't say disastrous effects. I've assisted in the intubation of patients who were conscious in the emergency room. This does happen in the field, of course. If you were assisted by an EMS crew at an auto accident or something of that nature, we - EMS crews do intubate people without sedation, but it's pretty hard on a person.
We - if we must secure an airway to keep you breathing, we will do everything we can to keep you alive.
CONAN: Linda, thank you, and I hope I don't meet you anytime ever.
(SOUNDBITE OF LAUGHTER)
LINDA: Well, I'm not the sort of person you're glad to see, but when you do need me, you're happy to meet me.
(SOUNDBITE OF LAUGHTER)
CONAN: Okay, Linda, thanks very much.
KNOX: By the way - excuse me, Propofal is one of the three dozen drugs on today's FDA shortage list.
CONAN: So it is - this is going to be a continued problem, again despite the stories we've heard about the usage of that drug in the Michael Jackson trial. Richard Knox, stay with us, would you?
KNOX: Sure.
CONAN: We're talking with NPR correspondent Richard Knox about drug shortages and the difficult decisions many doctors and patients face when medication runs out. If you have been affected by a drug shortage, call and tell us about your experience, 800-989-8255. Email us, talk@npr.org. Stay with us. I'm Neal Conan. It's the TALK OF THE NATION from NPR News.
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CONAN: This is TALK OF THE NATION from NPR News. I'm Neal Conan. We're talking about the nationwide shortage of key drugs. More than 200 medications are in short supply. Drug companies and doctors have had to ration treatments. Many patients can't get them at all. Howard Koh, assistant secretary of health, called it a dire public health situation. Today, a look at the causes and effects and possible solutions.
If you've been affected by the drug shortage, call and tell us about your experience, 800-989-8255. Email us, talk@npr.org. You can also join the conversation on our website. That's at npr.org. Click on TALK OF THE NATION.
NPR health and science correspondent Richard Knox reported on this yesterday, on MORNING EDITION. You can find that story at npr.org. And he's with us from his home in Dorchester, Massachusetts.
T: I'm in remission right now for ovarian cancer. Ovarian cancer is notorious frequent in its recurrence. The drug I'll need for that recurrence, Doxil, is nearly impossible to obtain right now. Isn't that just unbelievable that here in the U.S. we don't have access to effective drugs that save lives. I'm both angry and terrified.
Well, let's put her situation to Bona Benjamin, who joins us here in Studio 3A, director of medication-use quality improvement with the American Society of Health-System Pharmacists. And nice to have you with us here today.
BONA BENJAMIN: Thank you, Neal, nice to be here.
CONAN: And why can't the manufacturers of Doxil make more?
BENJAMIN: Well, in the case of Doxil, there is only one plant in the world that makes it, and since it is apparently having quality problems now or some kind of problem that has interrupted production, there's no Doxil to be had except in a very limited supply.
CONAN: Normally, if there's a necessity like that, someone else will step up and say here's an opportunity.
BENJAMIN: Normally, yes, I imagine that they would. And we know that in cases where there are shortages of critical drugs that FDA sometimes works behind the scenes. Their Drug Shortages Program staff with contact other manufacturers and ask them if they would consider stepping into the gap and producing these critical drugs.
CONAN: But these - don't these companies make a profit from these drugs? Wouldn't they respond on their own to a marketing opportunity?
BENJAMIN: One would think. I'm not a pharmaceutical industry expert, but it seems reasonable that a company would not make a drug if it were not profitable.
CONAN: Richard, as you've looked into this, is that the explanation you're hearing?
KNOX: Well, the FDA says that only 11 percent of the drug shortages that we're seeing are due to a company deciding this drug doesn't make me enough money, I'm just going to stop making it, that most of them are due to either the manufacturing problems and contamination or whatever or not enough capacity to meet the demand, that's the usual phrase.
But I think we have to step back and look at what might be called a structural issue in the industry, and again this complicated stuff, and I don't understand it, really, but over the past 10 years or so, it looks as though there's been a great consolidation in the number of companies who were interested in making these injectable drugs.
So as I said before, only seven companies produce most of them, and in a given drug, only one, two or three may make it. So there's kind of domino effect when something goes wrong.
Now, that seems to say that these drugs are not a very attractive business opportunity, I mean, that you can't make the tens of thousands of dollars per patient that you can with a brand-new, designer, cancer drug, for instance, or multiple sclerosis drug.
These tend to be older drugs. They've been around for a while. They're generic, many of them, most of them, and therefore apparently the economics of it are not in favor of a robust supply chain, something that's going to hold up when a problem arises with one company.
CONAN: Bona Benjamin, that suggests that this is the new normal, then.
BENJAMIN: Well, I would just take a little bit of issue with what Richard said. You know, third-party payers encourage the use of generic drugs rather than the more expensive brand products if there is a choice between them. So I believe that is one of the reasons why so many of the large manufacturers acquired firms that would make generic products, so that it could bring those generic products into their business.
And I have to believe that since seven companies are making generics that they must be making a profit off of them. How much I don't know because I don't have access to that information, but, you know, with generics being the preferred products, one would assume that there is a market for them.
CONAN: Let's get another caller in on the conversation. Eddie's(ph) calling us from Chico in California.
EDDIE: Hi, thanks for taking the call.
CONAN: Sure.
EDDIE: A year or so ago, my wife started suffering some arrhythmia problems, and one of the drugs that worked, in fact the only drug that kind of worked to control her arrhythmia was a drug called Mexelti(ph). It's not an injectable. It's been around for a few years, and it was very effective at controlling her arrhythmia.
The problem is that at the time, there were three manufacturers, and two of them elected to stop manufacturing, especially in the dosage that she takes. So the challenge we ran into was trying to find her the proper daily dosage when there was a dwindling supply of everything.
One of the things that her cardiologist did was change the interval of time that she actually took the medication. Another change that he made was to change the number of pills. For instance, she might take five of a lower dosage per day as opposed to three of the quote-unquote normal.
And the most frustrating thing for us about it was that this drug was not readily available simply because there was no manufacturing. It could be compounded by any of several compounding pharmacies, but our insurance company said that, well, it's a commercially available drug as it is, so there's no need for you to compound it.
And the good people at CareMark, our insurance provider, simply refused to do any coverage of the compounding because it was available commercially, even though there was none to be found. And the way it finally got resolved is our local pharmacist, who is not part of a large chain, worked his contacts and kept her in a steady supply of this pill until the manufacturing process caught up to demand.
CONAN: Bona Benjamin, that's clearly not an option for a lot of people. And I'm not sure it's an option for a lot of drugs, either.
BENJAMIN: Well, it's not. Not all drugs can be easily compounded, and some drugs or some therapies probably shouldn't be compounded in compounding facilities - or maybe not compounding facilities but in pharmacies. And by compounding I mean making a large quantity of drug for distribution for multiple patients.
We recently heard about (unintelligible) nutrition solutions, intravenous feeding solutions, made by one compounding company that caused infections in patients and deaths. So while compounding is part of a pharmacist's training and education and part of their job, compounding is a fairly complex activity, and you really have to be careful.
And I'm very sorry about this caller's situation. That's not an uncommon thing that we hear when only one manufacturer makes a product, what we call a sole-source product.
CONAN: Eddie, how's your wife doing?
EDDIE: Well, the medication is currently be manufactured. Again, they've caught up to demand. She's doing well. In fact, we're on our way now to see her cardiologist for a follow-up. But she's doing well under the medication. I just hope that it continues to be available in some form because this particular one seems to be the one that she responds to.
CONAN: All right, thanks very much, we wish her the best of luck, Eddie.
EDDIE: All right, thank you.
CONAN: And I wonder, Bona Benjamin, pharmacists are among those who are having to make these decisions about who gets what.
BENJAMIN: Well, pharmacists are involved with physicians and other members of the health care team in developing strategies, we call them conservation strategies, we also call them prioritization strategies. They are in fact rationing, but it's not rationing as I usually think of it. It's simply using the amount of product that you have to benefit the most people in the most possible - to give them the best possible effect from the drugs.
CONAN: Richard, as you've talked to people who have been forced to make these kinds of decisions, this is unusual. You know, of course everybody tries to make the decision on the greatest good, but these are awful decisions.
KNOX: Yes, so far people have said to me that they're usually able to make substitutions, that it causes a lot of anguish and anxiety within hospitals because instead of using a familiar drug that they know well, and they know how to - you know, the IV pumps are set to administer it at a certain rate, and they know how much a given patient should have, if they're using a substitute or a combination of drugs, then that can increase the risk of a medication error, a dosage error or what have you.
And they say that must be happening out there as a result of having to do these workarounds. There is a lot of anxiety about - I think especially cancer drugs because these are patients who, as Susan Kennedy said, need it on a timely basis.
And there's a drug named Taxol now that's a really the mainstay drug for a lot of cancers, breast and ovarian in particular, that is in shortage and there's a lot of concern that that may raise some very acute decision - problems, you know, who - this patient versus that patient problems. With Doxil, there is a substitute drug that though the problem is it's much more toxic. But with Taxol, you know, you have a little bit more critical need, I gather.
CONAN: And, Bona Benjamin, is there a temptation at one hospital or another to say, if Taxol is running out, why don't we stock pile it to make sure our patients have it?
BENJAMIN: Well, we've heard that that is happening, that care providers at hospitals are charged with taking care of their patients and so they try to acquire as much of the product as they possibly can. It's interesting that Taxol is one of the drugs mentioned because I was with a pharmacist, a friend of mine, the other night and she said we have lots and lots of Taxol now. We didn't have it for a long time, but we have lots and lots of it now. And we hear - at ASHP, we hear things like that all the time, where many, many people will be reporting a shortage of a particular drug, but yet some have lots and lots, and we don't understand how that happens.
CONAN: Shortages lead to market distortions and, Richard Knox, to black markets.
KNOX: Yes, but there's something called grey market that is causing a lot of the concern. This is not apparently illegal, but suppliers, distributors will garner a supply of a drug in shortage and offer it to desperate hospitals at an extreme mark up. And I just heard today that one - there's some interest in Congress in investigating or there is an investigation on grey marketing, and whether that - whether anything should be done about it.
One of the problems, a lot of hospitals don't want to buy those because they're not quite sure what their providence is, what - whether they are what they say they are, whether they're pure or whether - how they've been handled and stored and because it's a kind of an extortion and hospital is liable if there's some problem with the drug.
CONAN: NPR science correspondent, Richard Knox. Also with us is Bona Benjamin, director of Medication-Use Quality Improvement with the American Society of Health-System Pharmacists. You're listening to TALK OF THE NATION from NPR News. Let's go next to Jim and Jim is on the line from Binghamton, New York.
JIM: Neal, thank you for taking my call.
CONAN: Sure.
JIM: I deal intimately with this issue. I'm a - run an EMS region on behalf of the State Department of Health here in New York, and we were meeting on this very subject last night. One of the biggest concerns we have from a pre-hospital care setting is that EMS may be able to get drugs that are in short supply across the country, but we can't get it in the formats that we're used to handling it in, or one that is safest for our patients, or more importantly safest for our providers to administer. Norepinephrine was - I heard earlier in the conversation was mentioned, and, while it's certainly a widely available drug in some of the pre-mixed syringes in the last few years those have gone away, and it requires our providers in the field to brush up on their drug math and do better calculations rather than just grab a ready-made, ready-mixed medication.
CONAN: And that's for people in anaphylactic shock. That's quite serious.
JIM: Yeah.
CONAN: Yeah.
JIM: Yup. And obviously, there's a timeliness to those calculations in certain patient situations.
CONAN: And what kind of decisions are you making?
JIM: Well, the doctors and the pharmacists as well as our hospital physicians and our hospital pharmacists have been working very closely in my particular region here in Binghampton area, despite the flooding, to work out plans. I like the term from the woman from ASPH about prioritizing. We work very closely with our hospital pharmacists to make sure that we have the drugs in the formats that we need in the times that we need them and try to do a lot of planning. Even though some of our ambulance agencies purchase their drugs on their own, many of our ambulances restock right at the hospital. So we try to let them know what are average uses are so we can have versions of those drugs available for resupply.
CONAN: The woman from the American Society of Health-System Pharmacists is smiling, so she's applauding your practices. Jim, thanks very much for the call. Good luck.
JIM: No, thank you. Take...
CONAN: This email is from Addie(ph) in Maryland: I have a young child being treated for severe ADD and bipolar disorder. We're on the third substitution for his ADD medication. I was just told that the liquid lithium we rely on is also no longer available. Since he cannot swallow pills, this is a big problem. For now, we can get lithium capsules and sprinkle them on apple sauce. This makes him throw up, though, so we lose a lot. I'm afraid that the liquid Abilify we also rely on will run out too.
And this email from Dan in San Antonio: Are there drug shortages at military hospitals? Is this affecting our injured, active duty service members? Richard, do you have any information on that?
KNOX: No, I don't. I actually haven't heard that there is, but it's not clear to me why there wouldn't be because the military doesn't make its own drugs. It relies on the same supply chain that the civilian hospitals do, I assume. Do you know, Bona?
BENJAMIN: I believe that the FDA workshop a week or so ago that there was a representative there from the Veterans Administration, and I believe they're having similar problems with the shortages.
CONAN: Let's see if we can get one more caller in on the conversation. Let's go to - this is Joanne(ph), Joanne from Lancaster, Pennsylvania.
JOANNE: Hi. I take an old, in fact, (unintelligible) that's B12 for neurological and autoimmune disease. And for the last several months, my provider has been unable to obtain that medication. Eventually, I was able to obtain it from CVS, but even they were unable to obtain it. That problem has been reported in our local newspaper for quite sometime, the last several months, and the cancer specialists there have reported that patients are calling from other communities and other areas trying to get their loved ones rotated to that hospital if it's possible to get some of the drugs by Taxol. And one of the questions that I had was whether these shortages are impacted by some recently changes to the law? I believe that they're related to remunerations for drugs that were either under-patent or coming out of patent. My understanding was that there were some recent changes regarding drugs. And...
CONAN: And, Bona Benjamin, can you help us?
BENJAMIN: Yes, I can. There are some drugs that - I think you're asking about drugs that are on patent or not. What I'm familiar with are unapproved drugs, which the FDA is charged with making sure that they become approved drugs before they can be sold. But I can tell you that for drugs that are in shortages right now, there's no FDA action contemplated against them.
CONAN: Bona Benjamin, thank you very much for your time today. And, Richard Knox, thank you too. The junkie comes up next as we talk about Chris Christie. This is NPR News. Transcript provided by NPR, Copyright NPR.