For our October Readers’ Review: a novella that became an instant classic when it was written nearly two centuries ago. It is the ghostly tale of a lanky loner and a headless horseman. Some even call it the first American horror story. Join Diane and her guests for a discussion of “The Legend of Sleepy Hollow” by Washington Irving.
12 people have died and 121 in 10 states are sick with a rare form of fungal meningitis. The outbreak has been linked to tainted steroid injections used to treat back and neck pain. In all about 13,000 people in 23 states may have been exposed, and for many it’s now a waiting game to see if symptoms develop. An investigation is underway into how and why these contaminated medications were produced and distributed. Please join us to discuss drug manufacturing and public health
- Denise Grady reporter, New York Times
- Jeffrey Gibbs attorney in private practice, Hyman, Phelps and McNamara
- Dr. John Dombrowski medical director, Washington Pain Center
- Dr. Michael Carome deputy director, health research group Public Citizen
- David Miller executive vice president, International Academy of Compounding Pharmacists
MS. DIANE REHMThanks for joining us. I'm Diane Rehm. The investigation continues into how steroid injections produced and shipped to health facilities in 23 states lead to an outbreak of a rare form of meningitis. So far, 12 people have died, more than 100 are sick, and several thousand patients are waiting to see if symptoms develop.
MS. DIANE REHMJoining me to talk about the situation and its public health implications: David Miller of the International Academy of Compounding Pharmacists, Michael Carome of Public Citizen, Dr. John Dombrowski of the Washington Pain Center and Jeffrey Gibbs, an attorney in private practice. Do join us with your questions and comments. Call us on 800-433-8850. Send us your email to email@example.com. Follow us on Facebook or Twitter. Good morning to all of you.
MR. DAVID MILLERGood morning.
MR. MICHAEL CAROMEGood morning, Diane.
DR. JOHN DOMBROWSKIGood morning, Diane.
MR. JEFFREY GIBBSGood morning, Diane.
REHMFirst, we're going to talk with Denise Grady of The New York Times. She's on the line with us from Nashville, Tenn. Good morning, Denise.
MS. DENISE GRADYGood morning.
REHMI gather that Tennessee is the worst-affected state so far. Tell us why that is.
GRADYTennessee received what the health commissioner here is calling a disproportionate number of vials of this contaminated drug. There was one pain clinic here at Saint Thomas Hospital that actually had 2,000 vials of the medication that they were using for these injections that were, you know, being given into the spinal area to -- for back and neck problems. So they really have become the epicenter of it. They've got more cases and more deaths now than any other state.
REHMDo we know exactly how many people are affected by this drug?
GRADYThe estimate now is that 13,000 people have had injections with vials that came from the lots that are known to have had some contamination in it. Was every single vial contaminated? Nobody knows that. Or if they were, did they all have the same amount of these organisms in them? No one really knows the answer to that either. So it is -- as you said when started, it's a waiting game for people who have had these injections to see whether or not they get sick.
GRADYThe incubation period, at first, was thought to be about a month. But now, it seems as if it can be longer, more than a month. The health commissioner here in Tennessee yesterday said that some of the experts looking at this are saying that it may be that people are going to have to be on the alert for symptoms for three months.
REHMBut, you know, that's difficult. How many of us, on an ordinary day, might have a neck pain, might have a back pain, might have a headache? I would imagine there could be a lot of false positives.
GRADYI would think that if you have had one of these injections, it would be really hard not to think you've got a headache or some of the other problems that are associated with this. It has to be pretty nerve-wracking.
REHMAnd what do we know about the company that turned out -- that manufactured these steroids that turned out to be tainted?
GRADYThe company is called the New England Compounding Center, and they're in Framingham, Mass. And they were known as a compounding pharmacy, and compounding refers to pharmacies that make up prescriptions and mix up their own medications and solutions. And this was something that was originally meant to be done to kind of tailor-made prescriptions for people who had special needs.
GRADYBut in recent years, possibly because of kind of loose regulation, some of these compounding pharmacies have been doing very large-scale operation that start making them almost like miniature drug companies, and yet they don't have a kind of oversight to use sterile procedures and quality control like you'd have at a big company. They sell this stuff fairly cheaply compared to the big drug companies.
GRADYSo this whole thing has become -- it's kind of a perfect storm of, you know, companies that aren't regulated, aren't using the right kind of techniques. A widely popular procedure, something like 5 million people a year in this country get these steroid injections, and here's where we are.
REHMAs I understand it, some 75 medical facilities in 23 states received these contaminated steroid injections from the New England Compounding Center. You went to Nashville to talk to the directors of one of the pain clinics that purchased from this company. What have you found out from them?
GRADYI do not have an answer yet. They have been promising interviews, and, so far, we are -- have not gotten in the door. So -- and this is the Saint Thomas facility. And they have been -- as I said, they've been kind of the epicenter because they are the ones who have gotten the 2,000 vials. We have talked to other pain clinics that have been buying their product from New England Compounding, and they had a variety of reasons. They said there were shortages. It was hard to get. New England had it.
GRADYThey also were offering it for a much lower price than you could get from some of the big drug companies, and that made a difference to some of these clinics. In addition, they were able to offer a type of it that did not have a preservative. And some of the doctors who do these spinal injections feel that the preservative that's in some of these other preparations is irritating to the nerves, and they want medicine that does not have it.
REHMDid you also talk with any of the affected families?
GRADYI did. And what is striking about it is that with a number of these people that -- sure, they had some back trouble, but they were basically healthy people and often active people who were getting these injections because their back or neck problems were getting in their way of being, you know, leading active lives. And so you've got families who had someone who was vigorous and healthy, and suddenly they are terminally ill, you know, dreadfully ill.
GRADYAnd the families -- in the cases of people who died, the families are winding up in the intensive care unit, being told that there's no hope, and in situations where it's time to turn off life support, this type of meningitis can cause strokes and really extensive brain damage.
REHMAnd, final question, from the onset of symptoms to that turning off of the life support systems, how much time elapses?
GRADYIn the cases that I've encountered, it's been a few days, a week, 10 days.
REHMDenise Grady of The New York Times, she is on the line with us from Nashville, Tenn. Denise, thanks for your reporting. We'll look forward to reading more about this.
REHMAnd now, turning to you, Michael Carome, you say this was a public health disaster 100 percent avoidable.
CAROMEYes. This problem originated because of lack of appropriate oversight, regulatory oversight by the Food and Drug Administration of compounding pharmacies. And for more than two decades, Public Citizen has been warning its members, its readers of its newsletters about the potential dangers of compounding pharmacy drugs. And in particular, drugs that are made to be injectable must be sterile in order to be safe. Those are the most dangerous products when there's not appropriate oversight of the manufacturing, of the production by a compounding pharmacy.
CAROMEAnd so this was a predictable event. I note that 11 years ago in California, there was a much smaller outbreak with the same type of medicine that was contaminated with a bacteria -- not a fungus -- serratia. It led to approximately, in -- of 38 patients who got that injected drug from a compounding pharmacy in California, approximately 20 were hospitalized, five got meningitis, and three died.
CAROMEAnd shortly after those events, the San Francisco Chronicle wrote what is a really chilling editorial, and they said the following: "The recent deaths and disease resulting from a contaminated batch of pharmacy medicine should be a jarring warning to public health officials. Either step up oversight and regulation of pharmacies or swallow hard and brace for an even more devastating catastrophe." We are now living through that catastrophe which was predicted more than 10 years ago.
REHMMichael Carome, he's deputy director of the health research group at Public Citizen. David Miller, with the Academy of Compounding Pharmacists, how do the compounding pharmacies get around the FDA? How come there is no oversight by the FDA?
MILLERThat's a great question, Diane, and the actuality is that pharmacies of any type, including compounding pharmacies, can't get around the FDA. The Food and Drug Administration has the ability -- and has always had since the implementation of Food, Drug, and Cosmetic Act 75 years ago -- to walk into any facility in the United States -- pharmacies, hospitals, even gas stations -- any place that medications, medicines are sold, stored and inventoried.
MILLERWhat we know about this particular pharmacy -- and I hate having to admit that they are a pharmacy because of this particular tragedy -- they had been warned by the FDA multiple times.
REHMMichael Carome and David Miller. David Miller is president of the International Academy of Compounding Pharmacists. More when we come back.
REHMAnd we're talking about the outbreak of a fungal meningitis as a result of steroids injected either spinally or into the neck by individuals who received these steroids particularly from the New England Compounding Center. And, David Miller, just before the break, you were saying that this particular center had been warned previously, indeed about this very drug.
MILLERThat's exactly right, Diane, and pharmacies are regulated by three different government agencies. One is the State Board of Pharmacy, which protects the citizens within its boundaries, and then, in addition to that, as I mentioned before, the FDA, who keeps an eye on the drug supply, how things are manufactured, how they're stored. What I receive, whether I'm a small pharmacy that owns my own practice or a major chain or a grocery store, the FDA has the ability to make sure those pharmacies are watching those drugs and storing them properly.
MILLERAnd then we have the Drug Enforcement Administration that oversees controlled substances. There was a significant breakdown, and as the investigation continues into this particular situation, we know not only that the FDA had warned this pharmacy and had been inspecting it several times over the past decade, they have also been warned and had disciplinary actions and a consent agreement with their own Massachusetts Board of Pharmacy.
MILLERAnd what concerns us as health care professionals, as pharmacists, and certainly as compounders is, if the agencies that are designed to assure that we as pharmacists are doing what we're supposed to, knew this pharmacy was a problem, had taken action against them, why was that not two major red flags to our regulatory agency to be keeping an eye on them? And it is absolutely untenable for us who are trained as pharmacists to be involved in a situation where people have been harmed. That's not what pharmacists or physicians or anyone in the health system does.
REHMAll right. And turning to you, Dr. John Dombrowski, I gather you're treating patients in this very way, injecting steroids into the spine to help ease pain and -- for not only the back but the neck. How do you know, and how do you screen where those steroid drugs that you use are coming from?
DOMBROWSKIThat's a great question. I will tell you, I've always purchased through -- for my own office setting, my own practice, through a large provider called McKesson, and they're very large providers that, you know, get me my steroids. I will tell you, I'm just of the assumption that there is a certain quality control when I purchase the product.
DOMBROWSKIYes, because I'm in the United States of America. You know, there are certain quality controls that I know when I buy a tray for my needles, my syringes, all those things that need to care for that patient, it's done in a sterile technique. It's always done that way. And I will tell you, I was quite surprised that compounding pharmacies were held to a different standard. I never knew this. I never knew this.
DOMBROWSKIAnd because, as a physician, when we get a vial of any medication, just as you as a patient get a product from your CVS, I'm assuming that it is what it is. You know, we have quality control that the Lipitor is the Lipitor and that, if it's a generic, it's going to be a certain type of generic. Obviously, we're going to have to look at it differently, but a lot of my patients have certainly big concern. And I've never even heard of this company. But, you know, we've certainly tried to allay all fears.
CAROMESo John made an assumption, and that obviously was a very dangerous assumption. We have a marketplace in which there is a double standard. You have your standard drug manufacturers like Pfizer and Merck, who are held to very stringent standards, both to get a drug approved in the first place before they can even send out the first dose.
CAROMEAnd then once approved, they have to follow standards or what are called manufacturing practices, very strict, rigorous standards to make sure your drug doesn't end up with bacteria or fungus is in it or poisons. And compounding pharmacies, which were meant to be, fill a very narrow niche...
REHMYeah. Explain that to me.
CAROMESo a compounding pharmacy -- and compounding has existed for centuries, and that's the way drugs originally came from. But we passed laws in this country in '38 to make sure drugs were safe and in 1962 to make sure drugs were effective that require that new drugs be approved and -- only if they were shown to be safe and effective. And these compounding pharmacies sort of -- the amount of drugs that they produced became a very small percent of the market. And they were supposed to be very narrowly tailored.
CAROMESuppose there's an available antibiotic that you can get from the marketplace. But it -- and you need to give it to a child who -- it tastes horrible, so -- and so the child won't take the medicine to treat, perhaps, a serious infection. The compounding pharmacy could mix it up with a flavor to help to help make it taste better, and that's for treating one patient. And that's a very narrow role. Or suppose someone's allergic to a component.
CAROMEThere can be inactive ingredients in a pill that occasionally a person is allergic to, but they still need the active ingredient. A compounding pharmacy can make up a preparation from bulk materials of that drug without that allergic -- the variation that causes the allergy.
REHMAll right. But if I go to a CVS, a huge chain across the country, and I hand in a prescription and CVS says, sorry, we don't have this, what do I do? Do I depend on CVS to get it from a compounding pharmacy because a large manufacturer doesn't make it? What happens?
CAROMESo in most cases where we're not faced with an emergent or urgent situation, the pharmacy will order it from another supplier. There might be, for a particular drug, multiple brand and generic manufacturers of that drug.
CAROMEAnd so they will order it. They won't compound a new medicine generally, except in very rare circumstances.
REHMAnd how often would a big chain like CVS send me to a compounding pharmacy because my child doesn't want to take the drug as it is?
CAROMEWell, the CVS itself might have a compounding function and, for example, add a flavoring agent to...
CAROME...for that particular patient under a doctor's order.
REHMOK. Jeffrey Gibbs, I would imagine we're going to see lots of lawsuits going on here.
GIBBSI would agree. When there have been other kinds of events like this, there have been lawsuits. But I think that even more profoundly is that expect legislation to be introduced. In fact, there's already talk on Capitol Hill of new legislation being introduced.
REHMTo do what?
GIBBSTo strengthen FDA's role, to modify the laws. It's interesting. The timing on this is actually very serendipitous for FDA scholars. Today is the 50th anniversary of the signing into law of the 1962 Drug Amendments, and those amendments were enacted as a direct result of the thalidomide tragedy. And now what you have 50 years later is another event which could be considered a seminal event leading to other legislation. There are going to be a lot of questions, though, about what the legislation should look like and being careful not to overreact in the face of this tragedy.
REHMBut would you agree with David Miller, who said that the compounding pharmacies undergo exactly the same kind of rigorous examination as do the drug manufacturers, the big-name drug manufacturers?
GIBBSThey undergo a different kind of regulation. There's the State Board of Pharmacy, and there is FDA jurisdiction. I think that the question that's going to come up is how FDA has exercised its authority. FDA has asserted for many years that it has the ability to regulate compounding pharmacies. It has, in fact, inspected a number of pharmacies. As in the case of New England Compounding Center, they issued a warning letter. There are other pharmacies that have received warning letters.
GIBBSSo there's really no question that FDA has the authority to regulate compounding. It's -- it is a question of how it ought to do and in what manner it should exercise that authority. Congress last visited this law 15 years ago. There is legislation that Congress adopted 15 years ago giving FDA clear authority over compounding pharmacy under certain -- and spelling out when FDA could consider a drug to an unapproved new drug.
CAROMESo I think what people on the Hill will be doing is looking at that law and seeing if it ought to be strengthened and probably pushing the FDA to take a harder look at its role in regulating compounding.
REHMJohn Dombrowski, as a physician exercising your best judgment for your patients, have you ever received steroids from a compounding pharmacy?
DOMBROWSKINo. I think the question is, I mean, you have to first ask the question, why are we doing this? Why are physicians or practices needing to do this? Well, there's a couple...
DOMBROWSKIOh, this meaning purchase from a compounding pharmacy...
DOMBROWSKI...versus, say, a Pfizer or a Merck I think was said. Well, a couple of reasons. Number one, there are drug shortages. The American Society of Anesthesiologists have been on this forefront in terms of helping patients get the appropriate drugs because many of these medications and methylprednisolone is a very old drug. They're off patent. They're generic. There's no real money to be made to manufacture them here in the United States.
DOMBROWSKISo if there's no money to be made, but I have liability, they will then go offshore to other countries to be manufacturing, where there's no quality control, no FDA. So when we do import these medications -- I'm talking about anesthetics, not necessarily steroids per se -- we can't even use these because we, you know, we check their medication. This is not the quality we can even use. So, again, there are a lot of shortages out there.
DOMBROWSKIAnd the second thing is it's a cost factor. From a -- any sort of office setting or a hospital setting, the government, Medicare, gives you a certain amount of money to care for the patient. And that's all you get. So if I'm a practitioner, say, in Tennessee and I can save money by purchasing from perhaps a cheaper compounding pharmacy, well, I'm going to do that with the assumption -- I'm sure they did do this -- that they're going to be regulated like the other guy.
DOMBROWSKII think that is a wrong assumption, but I'm sure they did that. I know that they did not -- oh, this -- it's a wrong -- it's a cheaper medication. There's no quality control. I'm going to do it anyway. No one will do that.
REHMBut wait a minute. What I want to understand...
REHM...from Michael Carome is how a steroid like this becomes so deadly in the process of manufacturing it.
CAROMEThe problem is we had a so-called compounding pharmacy enter into practice of what is large-scale drug manufacturing -- in this case, a drug that was supposed to be sterile but wasn't and was to be injected into the spine of patients. And that crossed the line from that narrow role of a compounding pharmacy that we talked earlier into wide-scale manufacturing. And that's an activity that the FDA clearly has authority to regulate...
REHMAnd did not.
CAROME...but has failed to do so. And they explained their authority in the warning letter to this and four other pharmacies, compounding pharmacies, in 2006. That said, these products -- it wasn't this specific steroid, but very similar mass-manufacturing -- are illegal. And if you don't cease and desist, we're going to seize those products.
CAROMEAnd so that just establishes the FDA's authority. But they failed to use it now, and we have this catastrophe.
REHMOK. So since 2006, when they wrote that letter, they had the authority to shut down the New England Compounding Center?
REHMBut they did not.
CAROMEThey did not.
REHMIs there any indication as to why they did not, David Miller?
MILLERDiane, we don't know. And I think one of the things that's been pointed out here, and for your listeners and the American public to recognize, is this pharmacy was not a pharmacy. It was acting as a mini-manufacturer, and that's why the folks in Tennessee, the doctors, thought that they were getting the same sort of medicine that they would get from Merck or Glaxo.
REHMAnd you're listening to "The Diane Rehm Show." We have lots of callers. Let's go to the phones, 800-433-8850, first to Bedford, N.H. Benfred, (sp?) you're on the air.
BENFREDHi, Diane. Thanks for taking my call.
BENFREDYeah. I wanted to point out something. The central issue, remember, is drugs, for any clinical trial, first off, is compounded, so we should start from the making. Drugs don't just start and go to Pfizer, and then they go through all the super processing process. And we should also remember even Johnson & Johnson, with their Tylenol recall, would -- they're a big company, but they still have changes in their products. And there's been a big recall on Tylenol. There's a shortage.
BENFREDNew England Compounding has done more good than harm. We have guns on the street that kill people every day. We don't just go saying, blah, blah, blah, just go shut out every gun -- or everybody should put that away or (unintelligible) every gun...
REHMOK. So is this a fluke? Is it something that clearly does not happen very often? Is this an excusable mistake? David Miller.
MILLERWell, I think your caller is accurate that there are recalls all the time...
MILLER...by manufacturers. In fact, just the other day, Hospira, which is a major manufacturer of IV solutions, pulled a recall because some of the IVs used in hospitals are contaminated with mold. We have recalls all the time. Pharmacists know that. Doctors know that as well. However, you asked, is this excusable because, well, it happened? No, it's not excusable. Our drug supplies are supposed to be safe and effective. That's what the FDA is.
MILLERSomething that we have to remember is this pharmacy was acting as a drug company and wasn't having the kind of oversight that it should have had, which is why we have the Food and Drug Administration in the first place.
REHMAll right. To Cleveland, Ohio. Good morning, Mary. You're on the air.
MARYHello, Diane. Thank you very much for taking my call.
MARYI am a pediatric nurse practitioner and work with children with special health care needs and often have to rely on compounding pharmacies to take a medication and put it into a form that a child can take, for example, through a gastrostomy tube and send families to compounding pharmacies to get their prescriptions filled. I also want to say that some of the major pharmacy chains are also doing compounding. And my question is, you know, what safeguards are planned to make certain that I'm not doing any harm?
GIBBSYeah. That's a great question. Pharmacies do important work in compounding. There are needs that can only be fulfilled by compounding pharmacies. And in the events right now with New England Compounding Centers, it's going to be important not to take measures that will prevent pediatric patients, for example, or elderly patients who can't take drugs to get the medicine that they need.
GIBBSOn the other hand, clearly there needs to be some review of the system to make sure that events don't happen, particularly when you have red flags. When you have a compounding pharmacy that has had multiple events, both at the state level and the federal level, then that should be a warning sign to the regulators to step in.
REHMJeffrey Gibbs, he's an attorney in private practice here in Washington with Hyman, Phelps, & McNamara. We're going to take a short break here. More of your calls when we come back. Stay with us.
REHMAnd welcome back. We'll go right back to the phones, 800-433-8850, to Anne Arbor, Mich. Good morning, Linda. You're on the air.
LINDAHi. Yeah. I have been using medication from a compounding pharmacy for over 10 years now, the thyroid medication which actually I'm just about to take. And I have tried other thyroid medications and have had terrible problems from them, heart palpitations and different sorts of things. And so my fear is that with this kind of thing that just happened, people are going to take this as a chance to over-regulate these pharmacies.
LINDAI know that this has been something that's been attempted in the past, and if something like that were to happen, people like me would have a lot of adverse health consequences because we can't take these other medications that are out there.
GIBBSThat's a great point. And I want to amplify on what I said just before the break, and that is, I don't know the specifics on the event here. But I do know that FDA and regulators need to watch out for warning signs. You -- and there are a number of things that FDA could be looking at and doing to review companies and compounding pharmacies for risks. There are adverse event reports that come in from physicians, for example. There are ways to get that information.
GIBBSThere needs to be a better coordination between FDA and the states as well. Now, pharmacists do not have to submit adverse events. So that would not come in as a standard system. But there are ways that FDA can get information. Interestingly, and this could be very pertinent here, a number of years ago, FDA began developing a rule on compounding that was going to be considered too dangerous to allow pharmacists to proceed.
GIBBSThat there are going to be certain types of compounds the pharmacist should not go ahead with. And FDA, after a relative short while, just backed off and never advanced that regulation. So I think that's something that people are going to ask about, why did FDA not proceed with rulemaking that had begun a decade ago?
REHMAnd I want to point out to our listeners the FDA was invited to participate this morning. They declined. Michael.
CAROMEI think this is the second caller to raise the concern that if we have more regulation by the FDA, then they're not going to be able to get their compounded drug. The two situations I've heard described sound like the appropriate role for compounding pharmacy. And FDA enforcement action against a compounding pharmacy that's mass-producing a drug and selling it to multiple states, introducing an inter-state commerce, that won't affect the two situations we've heard from the last two callers.
REHMTell me about the relationship between the compounding pharmacies and big drug manufacturers, Jeffrey.
GIBBSWell, there have been sometimes testy relationships between the two. There have been instances where compounded drugs have lead to the development of manufactured drugs. I've been told that minoxidil, for example, was one that actually, for bald...
REHMWhat's the brand name?
GIBBS...for baldness, that began with some compounding. But there had been a -- there have been complaints by the drug manufacturers that compounded manufacturers are selling products that are competitors, direct competitors, and that is unfair because the drug companies have to go to the FDA, get approval, comply with good manufacturing practices and other regulations.
GIBBSThere have been some letters submitted to FDA over the years complaining about this. And, in fact, the law and the policy -- FDA's policy say that compounded drug -- compounded drugs cannot be identical or essentially identical to manufacture drugs. So there is a limit in the law when pharmacists have compounded drugs that are identical, and there have been complaints submitted to FDA. I know that the agency has not always acted on those complaints.
REHMThe question of just how many inspectors the FDA might have to go after compounding drug manufacturers who've already received letters of warning when the numbers of the employees have been cut from an agency. And, secondly, when you have a revolving door system, both of those issues really worry me, Michael.
CAROMEI think those circumstances are things that contribute to the failure of the FDA to have prevented this type of situation. They tend to be a resource center -- take a resource-centric approach to enforcement, and they realize their resources are limited, and maybe where you have a big manufacturer selling 10 million doses of a drug versus one selling 10,000, they may shift their focus to that big manufacturer.
CAROMEThe problem is because the compounding pharmacies aren't held to the same manufacturing standards to make sure that somebody's going to be injected a sterile, it increases the risk that the compounding pharmacy's product are going to be more dangerous.
CAROMEAnd so even though brand name products made by drug manufacturers sometimes get contaminated, the frequency with which that happens is less than occurs in compounding pharmacy products.
REHMLet's go to Pittsburgh, Penn. Good morning, Norman.
NORMANI think you almost answered my question. Can anybody tell me what specific procedures a major drug company like Merck uses to make sure that this doesn't happen? And where did the New England outfit go wrong?
REHMGo ahead, David.
MILLERGood question. Manufacturers are held to something called GMP, good manufacturing procedures. That's in the requirements and the rules that they have to follow as imposed by the FDA before they can manufacture or bring a drug to market. Compounding pharmacies and all pharmacies -- in fact, the pharmacies that are in hospitals, whenever sterile compounding is involved, we're required to follow a similar standard. It's called USP797 which is almost identical to the good manufacturing procedure.
MILLERAlmost because it's designed for smaller amounts and smaller batches. And where we have a real problem here, a gap that we've got to look at from a regulatory standpoint but also as healthcare practitioners -- doctors, nurses, hospitals, pharmacists -- is this was not compounding of a small batch like your -- the caller who had a need for thyroid. She works with the local pharmacy. They do it right there.
MILLERThis was a pharmacy that was preparing mass quantities, selling it, promoting it, marketing it and treating it as if it were a manufactured drug, leading physicians to believe it was no different from a manufactured product.
REHMSee, that's where I worry, John Dombrowski, as to how you, as a medical doctor, injecting these drugs into patient's spines -- and I recognize you have great skill in doing so -- how can you be absolutely certain that the drugs that you're receiving are absolutely clean?
DOMBROWSKIWell, obviously that's a concern of myself as any physician that cares for patients. The way that I've always done -- and I think most practitioners -- is buying from a known reputable manufacturer. Just like if you buy a car, you're probably going to get a better deal you feel comfortable from the dealership. Now, granted you might pay a little bit more versus the used car, but you feel like you're getting a little bit something more with that value. So that is where I think there's some comfort.
REHMAll right. So go ahead, Michael.
CAROMEI think if -- imagine you're a patient and you have back pain, and the recommended treatment is a steroid injection, and you go to your doctor. Suppose the doctor said, you have two choices of medicine.
CAROMEI have one made by a leading brand name manufacturer that was produced in accordance with the best manufacturing standards that the FDA requires versus one made by the compounding pharmacy in New England that didn't have to follow those standards and for which the risk might be higher and doesn't have FDA approval. You get to choose which drug you want. Which one do you think patients would choose?
GIBBSYes. I think it's important again to go back to the point that if the drugs are identical then that should not -- that's not deemed compounding. And so a doctor should be prescribing a compounded drug only if there is a medical need. If there's something that the manufactured product can't offer, perhaps it's someone's allergic to a preserve or might be a dosing issue, but it should not be essentially the same.
GIBBSOne other point. We talked a lot about FDA, but FDA has made it clear over the years that it is deferring primarily to the states. And FDA simply does not have the resources to manage all the compounding pharmacies in the United States.
REHMOK. So the FDA sends a letter to the New England Compounding Center in 2006. Do states follow up? Does Massachusetts follow up?
CAROMEListen. This company was engaged in interstate commerce.
CAROMEYou can't ask Massachusetts to regulate things that occur outside its boarders. That's just -- this is a federal -- this requires federal intervention, federal oversight, federal regulation...
CAROME...in which there is regulation for it that exists. They have that authority as we've talked earlier.
GIBBSMassachusetts does have jurisdiction over compounding that occurs within the state, so whether the products are shipped outside the state or in the state...
REHMAs they were.
GIBBS...as they were, Massachusetts would have authority. Also, if you're shipping out of state, other states do have jurisdiction. And presumably -- and I don't know here, but presumably -- the pharmacy in question was licensed by other states as well. So there is the possibility of oversight by other states.
REHMBut, look, why do have the FDA if all of the sudden we're saying, OK, states, you take care of it. We don't have enough people. We don't have enough oversight. We don't have the money to do what we are chartered to do. I don't get it. I mean, this is the very first time in my life I've even heard of compounding pharmacies. And I know that an awful lot of people are going to be wondering now about those compounding pharmacies. But it does seem as though it's a federal problem. Let's go to Little Rock, Ark. Good morning, Melanie.
REHMYes. Go right ahead, please.
MELANIEDiane, thank you for taking my call.
REHMMelanie, excuse me. Are you on a speaker phone? I can barely hear you.
MELANIEYes. Hold on.
REHMGo right ahead, please. Good grief.
MELANIEAre you there?
REHMYes. I surely am. Go right ahead, please.
MELANIEYou've pursued the fact that the regulations are in place, and the FDA has the authority to regulate these pharmacies. But I hope that your listeners will realize that these pharmacies -- still a very important niche. Luckily, you haven't yourself needed this type of pharmacy. But if the regulators used the authority they have now to regulate those that are doing big business because the pharmaceutical industry is no longer making money on these drugs.
MELANIEThat point was brought out and not pursued that one reason these physicians can't get these drugs and they're at a higher price is because they've gone generic or the pharmaceutical companies are not making enough money on them any longer.
CAROMEI mean, in this case, many physicians could obtain and probably were obtaining...
CAROME...appropriate drugs that were marketed by standard drug companies so that while a few patients may have needed steroid injections 'cause they couldn't otherwise get them, most could have got them from a standard manufacturer with appropriate FDA oversight.
REHMYeah. But would they have been cheaper coming...
CAROMEUnfortunately, so there is economic incentive here both for the company making the compound -- they want to make money, and this is -- I believe I've seen reports of up to $2 billion business. And there are physicians who, if they can find a cheaper product, they will make more money on the procedure if they -- in their billings. So there are incentives financially on both sides, both the manufacturer and at the physician level or the clinic level or the hospital level.
REHMAll right. To Marshfield, Wis. Hi there, Mary. You're on the air.
MARYHi. I guess my question regards how the staffing level in the FDA has changed and what impact that has had on regulating pharmacy.
GIBBSWell, staffing has increased, but, you know, the FDA's responsibilities have also increased. The FDA has been given new authority by Congress over the years. There's been a lot of legislation in response to various events, such as Biaxin and other manufactured drug issues. And then more recently, just this last summer, President Obama signed into law another piece of legislation that increases FDA's authority and responsibilities. So FDA staffing has a hard time keeping up with the volume of activity, especially as you have overseas manufacturers.
REHMAnd you're listening to "The Diane Rehm Show." Let's go to Houston, Texas. Good morning, Nick.
NICKHi. Good morning. Thanks for taking my call.
NICKI just want to make the point that it's kind of being touched on by other speakers in your panel. One of the issues with these compounding pharmacies is they don't actually manufacture the drug, (unintelligible). They repackage the drug. They get it in bulk from abroad or other suppliers, and they put into small aliquots, which are then sent out to facilities. And it does not have to be a doctor's office. It can be hospitals as well.
NICKHospitals also -- actually, these -- particularly in this time of drug shortages, which one of the physicians mentioned that drug shortage is not just anesthetic drugs, antibiotics, all sorts of other drugs. So I just want to make the point that, you know, hospitals also use this and that they're not actually manufacturing the (word?). They're repackaging it.
REHMIs that so, David Miller?
MILLERIn some instances with medications, yes, because we are in a very critical drug shortage issue right now, but it is also something that begs the question in this particular case, but also as we deal with drug shortages is, compounding pharmacies are located in communities all across the country.
MILLERWhy was a clinic in Nashville, Tenn. ordering medication from a compounding pharmacy -- not a manufacturer, although they may have given the impression of that -- from Boston, Mass.? We have members, compounding pharmacists, who are accredited for doing sterile compounding...
MILLER...in Nashville, in Tennessee. What was being said by this pharmacy to doctors that led them to believe that they were something other than what they really were?
MILLERPossibly cheaper. Possibly they were giving the impression based on catalogues, materials, promotional stuff. They were actings of manufacture, Diane.
CAROMEAnd the caller is correct. So a lot of times, compounding pharmacists make things -- make drug preparation from bulk supplies. Many times, those bulk materials are not sterile. And if they are going to use that bulk material to make something as intended to be injected and there aren't appropriate procedures to sterilize it, this is a type of situation we have, you know, the catastrophe that we have.
REHMMichael, what is your advice to people who are listening out there in terms of where, how they get their drugs?
CAROMEI think it's important if you're going to a physician for a procedure that's going to involved injection as some type of medication, you should ask the doctor where was that drug made, where did it come from, and find out whether it came from one of the standard drug manufacturers that had to comply with all the FDA regulations for approval and manufacturing, or did it come from a compounding pharmacy? And if it came from a compounding pharmacy, you should ask...
REHMAre they going to tell you the absolute truth?
CAROMEIf you have a good doctor-patient relationship, hopefully they will. And...
REHMJohn Dombrowski, you can expect a lot more questions, I think, in the coming weeks and months.
DOMBROWSKIWell, you're exactly right. And I think this gives us a great opportunity as physicians to encourage that relationship.
REHMAbsolutely. John Dombrowski is medical director of the Washington Pain Center, Michael Carome of Public Citizen, David Miller of the International Academy of Compounding Pharmacists, and Jeffrey Gibbs, an attorney in private practice, be careful out there. Thanks for listening. I'm Diane Rehm.
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