Earlier this month, the House of Representatives passed the 21st Century Cures Act in a rare bi-partisan effort. The bill is meant to speed the development of lifesaving treatments, but critics warn it may also allow ineffective or even harmful drugs onto the market.
Critical shortages of medical drugs are becoming so common we’re facing a “public health crisis” according to some in the industry. So much so it prompted President Obama to issue an executive order aimed at easing the shortages. The concern is mostly over generic drugs given by injection. But within that area, the shortages are becoming acute and widespread. More than 180 drugs have been declared in short supply this year. Many of them are vital for treating childhood leukemia, and breast and colon cancer. Join us as we discuss the impact of the shortages and the government response.
- Heather Bresch president, Mylan.
- Dr. Christopher Lawlor pediatric oncologist, Children's National Medical Center.
- Sandra Kweder deputy director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research
- Gardiner Harris science reporter for The New York Times and author of the mystery novel "Hazard."
MS. DIANE REHMThanks for joining us. I'm Diane Rehm. President Obama signed an executive order earlier this week, which many hope will address America's increasingly critical medical drug supply shortage. Here with me to look at why doctors are having, increasingly, to find alternatives or delay treatment and the impact on patients: Gardiner Harris of The New York Times, Sandra Kweder from the Food and Drug Administration, and Dr. Christopher Lawlor from the Children's National Medical Center.
MS. DIANE REHMThroughout the hour, we'll be taking your calls. I'm sure many of you have experienced the shortages we'll be talking about. I must say, I, myself, have run into this recently. Do join us, 800-433-8850. Send us your email to firstname.lastname@example.org. Join us on Facebook or Twitter. Good morning to all of you.
MR. GARDINER HARRISGood morning, Diane.
DR. SANDRA KWEDERGood morning.
DR. CHRISTOPHER LAWLORGood morning.
REHMGardiner Harris, tell us how many drugs are facing shortages and what types of illnesses are affected.
HARRISSo, right now, Sandy probably would know this better than I do, but it's about 130 at the moment. There have been as many as 180, I believe, short this year. It's a record amount. These numbers keep edging up year after year after year, Diane, which is why there's sort of -- we've reached sort of a panic stage at this point. Chris, who's a pediatric oncologist, is here to talk about, you know, one of the terrible drugs that would short this year, which is for treating childhood leukemia.
HARRISI mean, many of these diseases that these drugs are meant to treat are actually -- they're deadly diseases, but they're curable if you have the right medicines. And then, suddenly, to have drugs that, frankly, have been around for decades -- some of these medicines, you know, came out originally in the 1960s -- and then, suddenly, to have them not there for physicians like Chris is just an absolutely astonishing situation. So it is why the government, in the person of Sandy and her organization at the FDA and now even President Obama, is organizing so fiercely to try to fix.
REHMSandra Kweder, what's causing the shortages?
KWEDERWell, at a very basic level, most of the problems that are resulting in shortages of these products have to do with problems at the manufacturing firms. Most of these drugs are -- that are in shortage are drugs that are, as you've already heard, older products. These are generic drugs that have been around for a long time. The good thing about them is that they are tried and true therapies that people count on. The ones of particular concern are also what are called sterile injectable drugs.
KWEDERThey're mostly drugs that have to be injected into a vein. They're not oral medicines -- although there are shortages of them as well. Producing sterile injectable drugs is very complicated. There are a limited number of generic manufacturers who can produce these, and they have to be produced in very specialized facilities. The facilities are aging, and to bring them up to current manufacturing standards is difficult and costly.
REHMHow many of these injectables are being manufactured outside of this country?
KWEDERThe ones that we're talking about are predominantly U.S.-manufactured.
REHMAll right. And is there a question of the margin of profit involved with the generics?
KWEDERI think where that may come into play is -- has to do more generally with how the generic industry makes decisions about what to make and how much to make. With regard to the individual shortages, I don't think that's a factor.
HARRISI mean, Diane, what's happening here is there's this increasing array of drugs that we use in this country. There are something like 5,000 different prescription medicines that have been approved for use, and while -- meanwhile, the generic drug industry has narrowed down -- it used to be the generic drug industry was made up of all this sort of small mom-and-pop players who sort of competed fiercely and overlapped with each other.
HARRISBut what's happened in the last 20 years is that the generic drug industry has gone down to just a handful of players. Ninety percent of these -- more than 90 percent of these drugs are made by seven companies, and, in fact...
HARRIS...the majority of the drugs are made by just three. And so you have very few players. They have very few facilities. If something goes wrong in one of those facilities, a huge number of drugs end up being affected. And in the vast majority of these medicines, 90 percent of the supply of a particular medicine is made by one manufacturer.
HARRISSo if that one manufacturer has a bad inspection, has something go wrong with their suppliers -- and while these drugs are made in the United States, Diane, the crucial ingredients of them, the active pharmaceutical ingredients, are merely all made in China and India in these mammoth plants that, frankly, are rarely inspected by Sandy's fellows out of the FDA.
REHMAt the FDA.
HARRISAnd so there are these enormous supply lines -- and, basically, what's happened is there's just a number of things than can go wrong at any given moment...
KWEDERAt any given moment.
HARRIS...and the whole thing can fall apart.
REHMDr. Lawlor, have you seen these kinds of drug shortages in the past? If so, how have you dealt with them back then?
LAWLORWell, in the past, it was very, very rare for you to hear from the pharmacy or from any hospital administration to say that there is a drug shortage. And in that point in time, people would try to determine what the next fallback would be or how they would be able to procure the drug from another method. Now, almost on a weekly basis, you get information sent to you at any hospital across the country to say, here are the lists of the following 100 or 150 drugs that we have in short supply.
LAWLORAnd as Gardiner mentions, it's not that easy to have another of the seven or another of the three pharmaceutical companies ramp up production in any meaningful way to impact your patient right then and there. So it is a very big problem across the country, both for pediatric oncologists, adult oncologists. And other drugs are, as Sandy mentions, sterile injectables, things, antibiotics, other cardiac medicines -- and so what physicians across the country are having to do is when they hear, oh, my gosh, my...
REHMSomething -- right.
LAWLOR...drug isn't available. What am I going to do?
REHMRight, right. Now, Sandy, some people have said that the FDA's burdensome quality control regulations are part of the problem here. How do you see it?
KWEDERI think the -- what's in -- we hear -- we do hear that a lot, and, you know, we -- our pharmaceutical supply in this country is really the gold standard for the rest of the world. You know, we are -- you know, I, as a patient, or my patients when I see them, when they get something from the pharmacy or injected in the hospital, they can be assured that this a high-quality product, that what's -- everybody -- that somebody knows what's in it, that it doesn't have metal shards in it or isn't contaminated.
KWEDERBut those standards -- the quality standards have not changed in 40 years. They are the same. What is a challenge, though, is when you have aging facilities to try and maintain those standards just like we all do in our homes. Trying to keep the place up to snuff requires continual reinvestment and at some time -- at some point, you got to do a wholesale renovation.
REHMDr. Sandra Kweder, she is deputy director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research. Dr. Christopher Lawlor is a pediatric oncologist at Children's National Medical Center. Gardiner Harris is science reporter for The New York Times, author of the mystery novel "Hazard." And if you'd like to join us, 800-433-8850. Send us your email to email@example.com. Join us on Facebook or Twitter.
REHMWhen you think about the kinds of drugs most being affected, you talked about pediatric oncology drugs, you talked about cancer drugs. What other kinds of drugs are being affected here?
HARRISWell, there are the anesthesia drugs, which are the, you know, crucial drugs for use in the hospital. These are nearly all hospital drugs, Diane, because, of course, they have to be administered. And let me just sort of say, you know, there are people out there who are criticizing FDA standards on this, but you are out of your mind if you do not want high standards on injectable medicines. You know, if you get a contamination event with an...
REHMWhat kind of contamination are you talking?
LAWLORBacterial contamination -- these things will kill you really fast.
REHMEven slivers of...
KWEDERGlass, metal shavings, fungus.
HARRISMetal shavings, right.
LAWLORAnd we're dealing with immune compromised patients when we're talking about these things (unintelligible) drugs.
KWEDEROftentimes -- I mean, these are people sick people.
HARRISSo you would go into septic shock, you know, in five minutes if you get...
REHMBut not even know why?
HARRISWell, oftentimes, exactly...
HARRIS...and until it's too late. So you want very high standards when it comes to these medicines.
REHMBut wouldn't you have to have the FDA examining those pharmaceuticals or the ingredients thereof coming from China and elsewhere to be truly certain?
KWEDERAnd we do. We do examine them. We inspect -- we do inspections in some of those -- in those foreign facilities that make these products. And we also inspect the U.S. plants on a regular basis, a periodic basis, to make sure that they are doing their job -- and they do -- assuring that the products that they are importing, when we're not in those foreign plants, are pure and not contaminated.
HARRISWait, Diane, they don't come close to -- I love Sandy here, but they don't come close to the amount of inspections that they need to do in some of these foreign plants. But they're about to get the money to do it from the industry itself.
REHMGardiner Harris of The New York Times. We'll take a short break. We'll take your calls when we come back.
REHMAnd welcome back. We're talking about the shortage of a number of very important generic drugs. Joining us now from Cape Town, South Africa, is Heather Bresch. She is president of a company, a generic drug producer. It's the third largest generic drug producer in the world and largest global generics company headquartered here in the U.S. Good morning to you, Heather. Thanks for joining us.
MS. HEATHER BRESCHSure. Thanks for having me.
REHMCan you talk about why you see the generic drug industry struggling to meet demand?
BRESCHSure. And, you know, I had the opportunity to listen to a little bit of the conversation prior to your break, and, you know, I do think there's a couple of misperceptions. I know there was a discussion about the process as being complex and the generic industry sometimes has a hard time meeting the complexities and so forth of these products. And I, you know, would like to just remind people that the brand industry, the brand and generic alike, the entire pharmaceutical industry has faced these shortages and the market disruptions.
BRESCHAnd many, many times, the brand industry is still making the products for generic companies. So, you know, as many of you know on the phone, the recall, the market disruptions have as much as the brand industry as the generics. And so many times, the -- once the product does goes go generic so brand companies can fill their facilities, they continue to make the product and put the generic label on it.
BRESCHSo it's very tough to distinguish the brand from generic from a manufacturing perspective because most plants are making those brand and generic products. So it is true that, when a facility is hit, it'll affect many products. But I wanted to just clarify that it's not -- it would be very difficult to say something's just a generic manufacturing facility. I think, you know, what you were touching upon right before the break, which is FDA's resources or lack thereof, to truly meet the demands of our global industry today.
BRESCHEighty percent of the raw materials that are brought in, or that are used for products, come in from outside the U.S., and 40 percent of the finished dosage form come from outside the U.S. And, you know, it's well-known that the FDA, the inspection rate in 2009, according to GAL, FDA was only able to inspect about 11 percent of foreign facilities. So the reality is we have a very vulnerable supply chain.
BRESCHAnd I think what, you know, one of the issues that's manifesting itself is that very vulnerable supply chain, and what we as the generic industry stepped up -- and, again, this would go across to the entire industry for a successful -- with Capitol Hill is that FDA absolutely needs to become globalized. And instead of operating under a 1938 law that is very antiquated and very domestic and give FDA the resources and the -- really, the teeth they need to strengthen our supply chain, and in the long-run, I think would very much go to alleviating these drug shortages.
BRESCHAnd I know that's not an overnight solution, but it's going to just continue to compound. I think one of the doctors earlier was talking about, every year, it just gets worse and worse. And until we fix the core of the problem, that compounding issue is going to continue. So we've come up with a proposal that will give FDA about $300 million a year, about $1.5 billion over the next five years to allow them to truly globalize in the sense that the resource and the manpower necessary to help strengthen the supply chain we have today.
REHMSandra Kweder, how much is that $1.5 billion going to help?
KWEDERI think it will help tremendously in assuring sort of the integrity of the drug supply chain. There is absolutely no question about that. How much it will impact the current situation we're talking about today related to drug shortages is another question. There are certainly elements of that that will, where a shortage is -- has approximate cost, an inavailability of active pharmaceutical ingredient, you know, from -- because it comes from a foreign, not previously inspected source where -- to replace one. Then, that's where that comes in.
KWEDERThe shortage situation today, however, the vast majority of shortages that we're seeing in the U.S. are related to production problems here in the U.S. They -- a very small percentage have to do with inavailability of ingredients. So it's related, the inspection, being able to speed up the inspection process so that when plants are doing things to try and address shortages, we can get in there quickly with our resources. These -- this new program that Heather is describing absolutely will help. Will it make an immediate impact on shortages? I'm a little skeptical about that.
REHMDo you actually believe that foreign manufacturers from China, India would allow, would agree to having the U.S. FDA begin to examine -- investigate their plans?
KWEDERWell, we already do to some extent.
REHMTo some extent.
KWEDERWe -- to some extent, we do. Their willingness to allow for that has increased in recent years as we have built relationships with other countries. The FDA now has offices in many of those countries and are trying to, you know, build cooperation and trust with local authorities to really facilitate our ability to go into these plants.
REHMHeather Bresch, what I'm confused about is that shortages in supply has driven up prices. But higher prices don't seem to encourage more supply. Why is that?
BRESCHWell, you know, I think, obviously, you know, when you go back to, unfortunately, to the basic supply and demand economics, you know, there are situations that don't -- and especially given the regulated nature of our business -- that don't immediately -- that demand doesn't immediately return supply. So I think that when, you know -- I agree with what was just said, and, like I said, it's not a short-term fix. I think that when you look at the shortage issue, what happens is sometimes -- and, especially, we're talking about some of these older products -- prices, it had become so hypercompetitive.
BRESCHSometimes, you know, we take something good and take it a little bit too far, as far as how cheap we want products to be able to be, and if, you know, if it's 10 cents, it should be able to be 5 cents. And, unfortunately, that, over the years, we (word?) a lot of players that can't continue to make product or these complicated sterile products at such low margins, and then you end up just having a couple of players.
BRESCHAnd then if someone has an issue and there's a shortage, and to get -- to spend the (word?) and to get a facility to have higher capacity takes time and takes money for the prices just to go back to, you know, dirt cheap. So I think that, again...
REHMGo ahead, Dr. Lawlor.
LAWLORI was just going to also comment, apart from just typical supply and demand economics as well, speaking from the pediatric oncology world, our demand is hopefully going to be somewhat consistent. A lot of the pediatric diseases are what we would term orphan diseases and that, I believe, there's not that many children each year diagnosed with cancer. While it is huge to that individual patient and that family, we are not going to have 100,000 pediatric cancer diagnoses.
LAWLORAnd so they're sometimes are not the same incentives. We're not talking about the new cholesterol-lowering drug or the new dyspepsia drug or anything like that. These are critical medicines for children with cancer that, again, would be life-saving. So as we rethink this whole process, you know, to have incentives for some of these orphan diseases is also important where the demand is not going to fluctuate rapidly hopefully.
HARRISRight. I mean, Diane, my conservative friends don't really like to hear this, but supply and demand just doesn't work in this situation. The demand is absolutely static. You know absolutely from year to year how many kids are going to get this cancer. It's the same year and year. And supply, as Heather talked about, is absolutely static because it takes two, three, four years to sort of set up these plants, get your supplies going. And so nothing is going to solve this situation in the immediate term. This is all long-term stuff.
HARRISAnd I think the other point that we have to make here is that, as Heather talks -- Heather's company is the only large company with a very large plant in the United States anymore. But the way things have happened is that all of the key -- a lot of the key manufacturing has gone abroad and that these shortages are a symptom of sort of a frightening situation in the United States where, increasingly, the strategic assets like -- you know, we don't make antibiotics in the United States anymore.
HARRISWe don't make all kinds of absolutely essential medicines, or at least we don't make the active pharmaceutical ingredient, which is the key part of these medicines. And so while we sort of can stamp the pills here and we can sort of put together the injectable medicine, you know, there's no way we're going to be able to do that without these ingredients from India and China. And Heather, actually, the woman on the phone, is the one who negotiated this deal to get the FDA more money to inspect these, in part, because she is at a disadvantage. She has this mammoth facility in Morgantown, W.Va.
HARRISShe has, basically, FDA inspectors living in her facility there, whereas her competitors, who make it in these India and China plants, see these FDA inspectors once in a blue moon. You know, you read some of these inspection reports from these FDA guys who go to these Chinese plants, and they don't even know how to get there. So, you know, there are real big, strategic issues going on here that these shortages are just a small part of.
REHMSo what is the...
BRESCHNo. And, Gardiner…
REHMGo ahead, Heather.
BRESCHI was just going to say, you know, I certainly appreciate that. And, obviously, the fight that we've taken to Capitol Hill is very much around American competitiveness. And, you know, he's right. We have an extremely large facility, one of the largest in the United States, and, unfortunately, we're very disincentivized to keep large manufacturing facilities or expand our manufacturing in the United States. I mean, we are growing all over the world. I have 25 facilities around the world.
BRESCHAnd the United States, because of not applying the same standard to foreign facilities as they do U.S. facilities, it's, you know, a reverse carom. It's a disadvantage, and it's an unlevel playing field.
HARRISBut -- and that's because the law in the United States requires FDA to inspect plants in the United States once...
REHMIn the U.S.
HARRIS...once every two years.
HARRISIt does not have a similar statutory requirement for foreign plants.
KWEDEROverseas. That's right.
HARRISSo FDA will go six, seven, eight years, sometimes, between inspections. And, in fact, at its present rate, it would take FDA 13 years to inspect all these foreign plants going into the United States.
REHMOkay. So what you've got is a Congress that is trying to eliminate regulations, eliminate more of what the FDA does. So is the money that Heather is talking about going to make a huge difference in the inspection of Chinese, Indian plants?
KWEDERI think that it will make a difference.
KWEDERAbsolutely, it will make a difference.
BRESCHNot only would make a difference, but what -- the important piece that still needs to be done -- and Congress has to do this -- is change the 1938 law. So everything that Gardiner just described is because that law that's still -- you know, 1938 was a long time ago, and this world was a much different place. Considering that that's the law that still governs the FDA should tell you how antiquated it is.
BRESCHSo that's the law because it was written very domestically that says every two years the U.S. manufacture. We want that law to say every two years, if you're selling products in the U.S., you're held to the same standard. So the...
HARRISAnd -- right. And let's -- the larger political point here is that when you hear the Republican presidential candidates sort of talk about how regulations are bringing this country down and it's the economy, you know, think of Sandy Kweder sitting here. You know, Sandy Kweder is a regulator, and FDA is probably the one regulatory agency that touches Americans more than any other.
HARRISIt regulates 25 cents of every dollar, and it just got new regulations to make food safer. It looks over drugs. And the Congress wants to cut its budget because of this whole thing going on in Congress.
REHMGardiner Harris of The New York Times and Heather Bresch. She is president of Mylan. Thank you so much, Heather, for joining us.
BRESCHYeah. Thank you. Thank you for having me.
REHMAnd you're listening to "The Diane Rehm Show." It's time to open the phones, 800-433-8850. Richard in Salem, Mass., good morning. You're on the air.
RICHARDGood morning, Diane, and good morning, panelists.
REHMGood morning, sir.
RICHARDI'm an internist, a general internist, in Massachusetts. And there's a related topic, I think, of great interest to many people, although they don't know about it yet, but it's related to the topic at hand. Because of, I gather, 1960 rules or changes within the FDA, a certain number of generic drugs have now been taken off of the shelf. In particular, an example would be colchicine, which cost literally pennies per pill -- maybe 5 or 6 cents or so -- which is no longer available as a generic.
RICHARDThere is now only one brand name, colchicine, exactly the same molecule, which costs in the neighborhood of $5 or $6 a pill. Colchicine is used commonly in the treatment of gouty conditions, very common disorder. And it's also used in very important situations for more unusual diseases. I think it would be very interesting to hear how this has come about.
KWEDERSure. I'll be happy to address that. That's an interesting question and point. What -- it's really not related to the shortages topic. However, there are many drugs on the U.S. market that are -- have never been approved by FDA. There are manufacturers out there who make drugs that we all commonly use, have taken. The colchicine generic that came off the market was one of those. It was made by a company that had never had an application.
KWEDERBasically, they were illegally marketing the drug. When a new company came to the agency and wanted to have their product approved and do the proper studies to assess the correct dose -- and, in fact, they found that the dose needed was much less than was commonly used in medical practice and far safer -- FDA was then able to go to the company that was illegally marketing the product and asked them to come off the market.
KWEDERThe consequence of that, however, is you've got a new brand name drug out there that can now charge a lot more.
REHMHow did the illegally marketed drug get on the market?
KWEDERMost of them have been there for decades.
HARRISIt's a scandal, Diane. And I'm sorry. I sort of have -- I'm the exact opposite side of the caller. I mean, listen. I'm very sympathetic. There have been multiple cases where, you know, a new branded drug comes on. It clears out all of the old unapproved generics, and they jack up their prices...
HARRIS...enormously. And it's -- and they just reap these huge gains, and it's terrible. But the fact that there are literally hundreds of drugs that are on the American market that have never been approved by the FDA...
HARRIS...never been examined by anybody, is just unreal, and it's across all kinds of different sort of disease states. And you can't even believe it.
LAWLORAnd then that goes to pediatrics in general...
LAWLOR...in that as a lot of the pharmaceutical companies are developing their drugs, there's a certain expenditure that has to be made to vet it. And, usually, that's done with an adult population. The medicines having less application for children, there's not that incentive to test them to the same degree.
REHMDr. Christopher Lawlor, he is a pediatric oncologist at Children's National Medical Center. Short break. Right back.
REHMAnd as we talk about the shortage of drugs, generics specifically, in this country, we're going to bring on someone who has been very directly affected. Jay Cuetara, good morning to you, sir.
MR. JAY CUETARAGood morning, Diane.
REHMThank you for joining us. Tell us your story.
CUETARAWell, sure. I was diagnosed in April of 2009 with stage four rectal cancer. And I'm being treated at UC San Francisco's Helen Diller Cancer Center and, over the past two years, have had several rounds of chemo. And this past August, as I was going for my sixth cycle of chemotherapy, after being pre-medicated and getting ready for the actual infusion, it turns out that the 5-FU, which is a fluorouracil drug injectable, sterile injectable, was not available. And as a result, I was not able to have my chemotherapy that day.
REHMWow. So was there a substitute? What did you do?
CUETARANo. Unfortunately, there is no substitute for it as you're going through an existing round of chemo. There is a substitute that can be made at the beginning of a round, but not while you're in a round of chemo. So, in this particular case, I could not have chemo that day and would -- had to wait until UCSF had the drug again. And luckily, in my case, they were able to acquire the drug the following week. So my chemo was only delayed one week.
CUETARAAnd for me, in my particular situation, it wasn't as pretty good deal as it is for other cancer patients who have leukemia or breast cancer or in a situation where they're -- they need to have their chemo on a very regular basis is what's going to make the difference between them being cured of the cancer or their cancer being life-prolonging.
REHMDr. Lawlor, can you speak to that?
LAWLORAbsolutely. One of the worst things that we have to do as physicians is certainly tell a parent that their child has cancer, and then imagine that you would have to tell the parent that the medication that their child might need is not available. That might only -- might even be worse. So we have to try to be as proactive as possible in identifying the shortages as they're coming through, working very closely with the pharmacy at your institution to find out if there's a substitute available that has the same equivalent properties.
LAWLORAnd then, again, it's -- I am very sorry that, you know, he had to go through this, to start a chemotherapy cycle and then, partway through, not be able to complete it. Staying on schedule has been shown to be very important in affecting cures, and you certainly don't want to be messing around with that.
REHMDr. Kweder, how much advance notice is the FDA given that a drug will not be available?
KWEDERWe often find out at the same time as the clinicians do because if a product --you know, someone can't get it, we take reports from pharmacists. We take reports from patients. Anyone who wants to call us about a potential about an existing shortage, we'll take reports. Where we can do the most is when we are aware of a company having problem -- production problems or any kind of problem that might result in a shortage.
KWEDERSo, for example, if a company has to shut a plant down for a month to do routine maintenance -- this is just making this up -- it's going to -- and they haven't planned for an adequate supply to be putting forward to wholesalers and facilities, if we know about that in advance, we can work to find alternative suppliers and suggest to them that they may need to increase their production. But that requires advance notice.
REHMJay, tell me how you are now.
CUETARAWell, fortunately, Diane, I'm doing great. I'm asymptomatic. And even though it's stage four, I'm still working full-time and, you know, feeling fine. I'm just very concerned with those folks that are -- you know, have very specific cancers or are in situations where they require that -- their chemo cocktail on a very regular basis and are not able to receive it.
REHMI think Dr. Lawlor has a comment.
LAWLORAnd just touching on that from the pediatric oncology world through our participation at -- with the Children's Oncology Group and national protocols, Children's National as well as some other institutions have been able to achieve cure for the common leukemias in over 90 percent of patients. But those patients are treated on clinical trials. In order to be on the clinical trial, you need to have access to all the medicines on that trial.
LAWLORAnd so if you are short a particular chemotherapy medicine, you're not able to enroll someone on that study. So apart from the immediate at-the-bedside impact, it also have -- may have an impact in slowing down the results that we get from our clinical studies in order to push that 90 to 95 to try and cure more patients.
KWEDERAnd this has been a big -- this has been recognized as an important problem by the NIH and other companies that are trying to do trials of new products.
REHMJay Cuetara, thank you so much for joining us. I hope your health stays strong.
REHMThank you. And let's go now to Paul in DeRuyter, N.Y. Good morning. You're on the air.
PAULGood morning, Diane. And thanks for the opportunity to talk to you and to your panel.
PAULI'm a 40-year veteran of the pharmaceutical industry, recently retired from Bristol-Myers Squibb Company in Syracuse. And as such, I am keenly aware of the antibiotics situation in this country. Basically, your New York Times panelist stated earlier in your show that none of the molecules...
HARRISYou were the last to make it.
PAULYes. None of the molecules necessary to make penicillin and cephalosporins are produced in this country anymore, the active pharmaceutical ingredients. And...
HARRISThe last plant was the one -- was your plant up in Syracuse.
PAULYes. We were the world leader in making antibiotics.
HARRISYou closed in 2004. Right.
PAULYes. And my mind goes back to the problem we had with the heparin. A couple of years ago, the FDA commissioner's feet were held to the fire by a Senate investigating committee when several people in this country died because the Chinese manufacturer deliberately used the wrong molecular form of heparin, and it killed a bunch of people.
PAULNow, can you imagine yourself as an auditor going to China to try to figure out some of these companies if they're dealing unscrupulously and avoiding the GMPs, deliberately trying to produce something to save money, knowing so well that it might be hazardous? First of all, all the documentation would be in Chinese. You need a skilled interpreter to help with that. And there's no way, even if the documentation were in English, that you could find that except for extensive testing of the APIs in the finished products and the input raw materials.
HARRISWell, I mean, what happened in that case, Diane, was it was absolutely deliberate contamination where people who did that knew that they were going to kill people because, you know, in most of these sort of situations, of course, people take the shortcuts in the -- for instance, we remember the case where the peanuts were contaminated. Well, they just had a terrible plant where bird dung was able to sort of get into the plant and contaminate the plant. But they didn't do anything deliberate.
LAWLORIn the case of the heparin, these people actually knew the test that was being used to sort of determine whether it was real heparin. And they came up with a fake that they knew could pass the test. So it was actually a very deliberate fraud.
REHMOkay. So we go back to Paul's question as to how the FDA could possibly get in there, could discover, could prevent an accident of that magnitude from happening.
KWEDERI think the answer to the heparin situation is extremely complicated there. The product in question was -- is very unusual.
HARRISIt's made from pig intestines, Diane.
KWEDERFrom pig intestines, coming from a variety of sources and pig farms in China.
LAWLORHundreds of pig farms across the thousands -- across China, right. And, in fact, the FDA was not allowed to investigate. The Chinese authorities did not let FDA people in there.
KWEDERWe could not investigate to understand.
REHMBut then how could you allow that drug on the market?
KWEDERWhat was happening was that we -- because we couldn't investigate those places, we -- there were requirements to test heparin for purity. The standard -- and there is -- was a standard test for heparin for purity of the product coming in, and all the manufacturers, U.S. and worldwide, utilize that test to assess the purity of the drug product. But the substitute for the active ingredient that was being used to meet production quotas in China mimicked the heparin molecule and could basically skirt by the test.
HARRISRight. But this is the point, Diane, which is that testing the ingredients does not assure safety. It never has.
KWEDERNo. You have to go to the source.
HARRISThe FDA knows this. This is why the FDA desperately wants to inspect these plants...
HARRIS...has not been able to for decades because of money.
REHMBut how -- but, thinking about Paul's points -- number one, documents in Chinese, number two, substitutions, complications -- how can we ever know for sure a drug is what the Chinese or the Indians say it is?
KWEDERI think one solution is broader inspections. Two is making sure that at every step of the process there are quality checks. And that's what the FDA regulations really try to do is at every step of the process, be doing quality checks. Some people call that being pointy-headed and bureaucratic, but there are always opportunities for things like heparin, for substitutions, you know, cutting corners. What we require is verification -- trust but verify, just like a teenager, but it's not -- there is -- this is not a substitute for some of the other things. But building quality in is essential.
HARRISWe're in a frightening situation. And Paul from Bristol-Myers, you know, the frightening thing from high perspective is, you know, I've covered Bristol-Myers for 13 years, and, you know, I know the guys over there. And I went to them when they closed this plant, or I went to them after they closed the plant and said, you know, by the way, did anybody come to you from the sort of U.S. government and say, hey, you know, it might actually be a good idea to have some facility in the United States that can actually make antibiotics, which are obviously, unbelievably crucial.
HARRISAnd they sort of shrug their shoulders and said no. And so we are losing -- in fact, we already have lost the critical capacity to make all the kind of medicines that keep people alive. If we ever get in trouble with the Chinese for a few weeks even and we stop getting these crucial ingredients from the Chinese and the Indians for a little while, the health care system in the United States will collapse.
REHMAll right. To Tulsa, Okla. Good morning, Larry.
LARRYGood morning, Diane. How are you doing today?
REHMFine. Thank you. Go right ahead, sir.
LARRYYes. Hi. My issue is that I was diagnosed as an 11-year-old with having HDDD, hyper displacement disorder. And as an adult, I have continued taking Adderall. And I was just informed by my pharmacist that the drug will no longer be available, and, in fact, I was one of the last patients to receive the dosage that was left at the pharmacy. They -- well, they don't expect to be receiving Adderall anytime soon.
REHMWhat do you think of that, Dr. Lawlor?
LAWLORI think it's, unfortunately, a situation that's becoming more and more common across the country. I'm not sure about that specific medicine, but this is, you know, the ramification...
REHMHave you heard that, Gardiner?
HARRISYeah. I mean, I think that, Diane, it's a sort of situation of a different sort of dosage. There's actually -- Adderall XR is still being sold, so you get the immediate release dosage that they are sort of phasing out where that they continue to sell the sustained dosage of, you know -- these are the sort of oddities that happen when you have 4-, 5,000 different pharmaceuticals that are being sold. Some things get phased out, and some things stay.
REHMAnd you're listening to "The Diane Rehm Show." To Thomas in Cincinnati, Ohio. Good morning. You're on the air.
THOMASOh, this is me then?
REHMYes, this is you.
THOMASOkay. Okay. Great, good, good, good. 'Cause I know I don't have much time.
REHMYou sure don't.
THOMASIt's very -- there has been a breakdown in the social contract between the drug companies and the people of the United States. They lied to us, the drug companies. They said, if we're allowed to make these egregious products on popular drugs, oh, we'll put back money into the less profitable drugs. They never did. We know where the money is. They were -- these companies were allowed to make billions upon billions of dollars, billions of which they put in to keep feathering their own nests. They were under -- I want to say copyright, but they were also under patent protection.
THOMASThey couldn't have made that money without the protection of the U.S. government. And as I agree with one of your spokespeople that said about how the supply-siders got it wrong, he's absolutely right.
REHMAll right, sir. I thank...
HARRISSo Diane, there are some solutions to this problem that our lefty caller here would have preferred that the administration didn't actually do. You know, there...
REHMWhy did you call him a lefty?
REHMHe may represent a great many people out there.
HARRISI -- well, absolutely. I think of, you know, only journalists are thought of lower than drug companies in this country, so that, you know, what the administration was considering, for instance, is, you know, is a stockpile of some of these medicines. They would actually stockpile the dry ingredients of these medicines, so that if they went in short supply, it would be a relatively easy thing to put them into an injectable form.
HARRISThere is a group of oncologists, some of Chris' colleagues, who are considering forming a not-for-profit drug maker to produce some of these medicines in a constant supply so that they'll always be available. And, of course, there were some, you know, thought within the government even to create sort of a government production facility. These are obviously -- tend to be on the left side of the spectrum sort of thoughts.
HARRISThe Obama administration, already under attack for health care reform, and Obama is frequently referred to as a socialist in the right. I don't think that they ever really thought that these sorts of solutions would sort of pass muster in this political environment. But there is no doubt that there are clear sort of failings in the private sector in these situations, and there are suggested solutions that would -- that, perhaps, would do other things.
REHMAll right. And two quick emails. Karen writes, "It's not just these injectables that people are talking about. I have chronic migraines. The only medicine that's worked for me for many years is now unavailable, Midrin." And Karen in Baltimore writes, "I've been a nurse for 35 years, I've never seen shortages like those we are encountering -- anti-nausea, narcotics, chemotherapeutics, vasopressors. Every week, there's something else we're short of."
REHMAnd that's where we have to leave it. I hope you all will continue your good work in this area. And I hope that the FDA has the opportunity to expand its reach so that the American people are protected from global -- what can we call it? -- misbehavior. Sandra Kweder is deputy director in the FDA, Dr. Christopher Lawlor is at the Children's National Medical Center, Gardiner Harris of The New York Times. Thank you, all.
HARRISThank you very much.
REHMThanks for listening. I'm Diane Rehm.
ANNOUNCER"The Diane Rehm Show" is produced by Sandra Pinkard, Nancy Robertson, Susan Nabors, Denise Couture, Monique Nazareth, Lisa Dunn and Nikki Jecks. The engineer is Tobey Schreiner. A.C. Valdez answers the phones. Visit drshow.org for audio archives, transcripts, podcasts and CD sales. Call 202-885-1200 for more information.
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