Debate Over Prescription Painkiller Regulations

MS. DIANE REHM

10:06:53
Thanks for joining us. I'm Diane Rehm. Since 1999, the number of deaths in the U.S. from narcotic painkillers has quadrupled. Now the FDA has put plans in motion to tighten rules on how these drugs are prescribed. But the new recommendations have some patients and doctors worried what it will mean for pain management.

MS. DIANE REHM

10:07:18
Here with me: Dr. Christopher Spevak of Georgetown University School of Medicine, Dr. Steven Stack of the American Medical Association, and, joining us from the studios of The New York Times, Barry Meier, New York Times reporter and author of "Pain Killer: A 'Wonder' Drug's Trail of Addiction and Death." And thanks to all of you for joining us. We'll take your calls, 800-433-8850. Send us your email to drshow@wamu.org. Follow us on Facebook, or send us a tweet. And, again, it's good to see you.

DR. STEVEN STACK

10:08:01
Good morning.

DR. CHRISTOPHER SPEVAK

10:08:01
Good morning.

REHM

10:08:05
Barry Meier, let me start with you. Explain to us exactly what the FDA has recommended and just what drugs we're talking about.

MR. BARRY MEIER

10:08:19
Good morning, Diane.

REHM

10:08:20
Hi.

MEIER

10:08:20
So the basic drugs we're talking about are hydrocodone-containing painkillers sold under the brand names of Vicodin, Lortab, and largely as generics. The step that the FDA is recommending is that these drugs be taken out of the category that they now are in and put into a category that has more stricter prescribing rules governing it. So...

REHM

10:08:45
Like what?

MEIER

10:08:47
Specifically the amount of pills that could be prescribed prior to your having to return to the doctor would be cut down from a 180-day supply to a 90-day supply. You, as a patient, would have to walk that prescription into the pharmacy rather than having the pharmacist call it in.

REHM

10:09:09
And these painkillers are currently regulated totally differently from, say, Oxycontin, and why? What's the difference?

MEIER

10:09:24
When the government put into place the regulations back in the 1970s that governed all pain meds, be it these meds or Oxycontin. They created the schedule, and the manufacturers of Vicodin at that time argued that because they contain acetaminophen that drug would somehow reduce the likelihood that hydrocodone-containing pain drugs would be abused. They also claimed they would be more effective. So essentially they were basically the only drugs that contained relatively strong narcotic to be left in this less-restrictive category than drugs like Oxycontin.

REHM

10:10:08
OK. So you've got this Schedule II and Schedule III classification of medications. And now you're putting hydrocodone-containing painkillers into Schedule II, the more restrictive classification. Is that correct?

MEIER

10:10:33
That's absolutely correct.

REHM

10:10:34
OK. So why now? Why is it taking so long? These drugs have been on the market for quite a while. Why has it taken the FDA so long?

MEIER

10:10:48
Well, I think there are, you know, two factors at play here. There's basically the scientific factor, which is, were these drugs prone to less abuse? And were less problems created in the public health arena because of it? The FDA argued for over 10 years that they were, but most researchers that you speak to say, no, that was basically straw man argument that covered the sort of more intangible issue. And that is patient access to these drugs.

MEIER

10:11:19
And that's the thing, I think, that they struggled with most. That is to say, if we now restrict these drugs further, are people that rely on these drugs -- bear in mind these are the most widely-prescribed drugs in the United States. They are also the most widely-prescribed narcotic painkillers. Will patients be adversely affected? And I think that's the issue that they grappled with. And there's tremendous lobbying from patient groups, drug manufacturers, drug stores arguing that that, in fact, would be the case.

REHM

10:11:48
Now, give me a specific example. What about something like Tylenol with codeine that's so frequently prescribed? Does it stay in Schedule III, or does it move to Schedule II?

MEIER

10:12:08
My understanding is Tylenol with codeine stays in Schedule II. (sic) Another widely used pain medication called Tramadol, which is currently Schedule III, stays in Schedule III. So both those drugs stay in Schedule III. It's just the hydrocodone-containing medications that are moved from Schedule III to Schedule II under this plan.

REHM

10:12:29
Barry Meier, he's New York Times reporter, author of "Pain Killer: A 'Wonder' Drug's Trail of Addiction and Death." Dr. Stack, as both an emergency physician and a member of the Board of Trustees with the American Medical Association, what's your reaction to the FDA's decision?

STACK

10:12:58
Well, we agree with the FDA that this is an epidemic, and it needs to be addressed. So there's no uncertainty about that. Prescription drug abuse is ravishing communities across the country. Where we disagree with the FDA is that rescheduling hydrocodone, that it will correct the problem or that it will fix it. And some of the concerns we have with this -- another very commonly abused prescription drug, oxycodone, which is the active ingredient in Oxycontin and other short-acting formulations, is also one of the most commonly abused prescription opioid medicine in the United States.

STACK

10:13:34
And it is already a Schedule II. So just changing the medication from Schedule III to II does not necessarily mean there'll be a positive impact on the abuse of it in the communities. The other issue we have, however, is there are patients throughout the United States, 100 million of them, the Institute of Medicine estimates, who live with chronic daily pain that's not adequately treated. So we're trying to balance the treatment of patients in pain and suffering with avoiding abuse.

STACK

10:14:02
And we have patients with acute pain, people who are post-operative or surgical or people who break an ankle or a bone of some sort. If we remove hydrocodone from Schedule III and place it in Schedule II, physicians will not have a medication sufficiently strong that they can prescribe for a patient via telephone to call a pharmacy on a weekend or after hours.

STACK

10:14:24
And even in skilled nursing facilities where physicians rely upon licensed nurses to act as their agent, assess a patient, call and request pain control, they'll be deprived the opportunity to give a verbal order over the telephone to give these medications to the patient. Because now they'll have to have written prescriptions.

REHM

10:14:44
Dr. Steven Stack, he's a member of the Board of Trustees for the AMA. Turning to you, Dr. Spevak, as professor of clinical anesthesia at Georgetown University School of Medicine, talk about how you see these restrictions and the effect they will have on both doctors and patients.

SPEVAK

10:15:12
Sure. I think that, you know, the public policy of having to restrict opioid medication as a result of the epidemic that we're seeing in terms of morbidity, illness, and death associated with the use of opioids is paramount. We know that we have 17,000 people in this country died in 2011 from opioid overdose. So this is one step, I think, in addressing that issue. However, other steps, such as education, education of physicians, education of patients, education of our communities, and programs such as this that bring this to the forefront, that show that it's an important issue.

REHM

10:16:00
How addictive are these so-called opioids?

SPEVAK

10:16:05
I think when we look in recent neuroscience has really illuminated and showed us how addictive they can be. And we know that addiction has to do with genetics and predisposition. But when we look at new initiates, it's disproportionally affecting our youth, also women. We know that women have a fivefold increase of prescription medication problems in the last 10 years versus men that have had a three-and-a-half-fold increase.

REHM

10:16:33
And why do you suppose that is?

SPEVAK

10:16:37
I think we know that there are different neurochemical reasons that women suffer more from chronic pain, so women have higher access to the medications.

REHM

10:16:49
And the other question: How well do these opioids actually treat the pain that they're supposed to treat?

SPEVAK

10:16:59
And that's the good question because, in the last 10 years, the field of pain management has expanded exponentially. We now have good alternatives to opioids. We have good alternatives. We have behavioral alternatives, physical modalities, complementary and alternative modalities that weren't available before. And these are substitutions for the opioids, and it can actually act a lot better in treating chronic pain.

REHM

10:17:24
What about that, Dr. Stack, other forms of treatment for chronic pain, sever pain that should perhaps minimize the need for these strong drugs?

STACK

10:17:41
I'd agree with that. And I think that the evidence that prescription opioids are good options for chronic non-cancer-related pain is probably thin and that these are not ideal options to treat most patients with chronic pain. The challenge is that, while there are new modalities, new things that we can do for patients, they are fairly new.

STACK

10:18:01
They're not necessarily as broadly available or as accessible to the typical patient, and therefore we have a long way to go to developing those so that they're more prevalent, they're more readily available, and people can benefit from them. So I think we have turned to a suboptimal treatment because it was the only one readily available.

REHM

10:18:19
All right. And I know there are many, many people out there who have questions. When we come back, we'll talk further, take your calls, your email. I look forward to speaking with you.

REHM

10:20:01
And welcome back. We're talking about the Food and Drug Administration's recommended tightening the way narcotic painkillers are regulated and the proposed changes on drugs containing hydrocodone expected to go into effect next year. Barry Meier, let me come back to you. Who is it who's abusing these drugs, and how widespread do you think the abuse is versus the actual need they're for?

MEIER

10:20:41
Well, you know, that's a great question, and it's the big balancing act here. The abuse is pretty widespread. I mean, the figures cited by Dr. Spevak speak for themselves. There are -- as far as the hydrocodone-containing drugs are concerned, 70 percent of the patients who receive them stop using them after 14 days. So it's only then...

REHM

10:21:04
Seventy percent, OK.

MEIER

10:21:06
Seventy -- a huge number. I mean, so the vast majority just use them for a few days for an injury, a tooth extraction, post-surgery and so on and so forth. They're done with it. So you have 30 percent that continue to use it for maybe another couple of weeks and then even a smaller percentage that use it, you know, for 90 days, which tends to be the definition of chronic pain and beyond. So how many of those patients are benefitting? That's a great question. And I think Dr. Spevak addressed that. We don't know if these are really great for long-term care.

MEIER

10:21:41
And I was struck by Dr. Stack's comment that this is a suboptimal treatment. They -- you know, he's acknowledging that. And what I find remarkable is, you know, is the AMA and other medical organizations out there lobbying for better pain treatments, treatments that work, treatments that help patients without posing an addiction abuse risk as opposed to lobbying for, you know, continuing access to these drugs?

REHM

10:22:09
And before I turn to Dr. Stack on that question, what about kids? What about young people getting a hold of these drugs? What evidence is there out there that that's happening?

MEIER

10:22:25
Well, there's -- you know, I can't cite you chapter and verse, but let me just say, from a visual standpoint, you as a patient could receive a refill -- refills for this drug that could last up to six months, right. You can get five refills, I believe. So the volume of these medications that you can get, you can store in your medicine chest, that people can sell on the street, is actually enormous.

MEIER

10:22:53
So you think about, you know, those two figures that people take it for only 14 days typically, but they can get prescriptions lasting as long as six months. That suggests that there's a sea of these drugs that are out there that are really not doing anybody any good.

REHM

10:23:09
But what is the impact of a large dose of one of these drugs? How does it affect behavior as far as you've seen, Barry, in your own investigative work?

MEIER

10:23:27
Well, these drugs are drugs that can produce dependence. Naturally, the body becomes adjusted to them. Then people crave them and keep using them. They may go on to become eventually addicted to them. So they create the same type of reaction that any narcotic does, be it a legal narcotic like these or an illegal narcotic like heroin. You know, there's a response that the body has. And, after a while, if it continues to take the drug, it continues to crave the drug.

REHM

10:23:59
Dr. Stack, do you want to comment on the AMA's role here?

STACK

10:24:03
So we agree with Barry in that essential tenet of the AMA's approach to this is more research and funding and support for better treatment options for chronic pain, as well as treatment for patients who have become dependent on these drugs or who have become abusers of these drugs. There are woefully inadequate options to treat people who have already become dependent or have problems with these medications. And so we have to invest as a society in treating those individuals who are already victimized by this problem.

REHM

10:24:33
But now, what about his specific question, why the AMA continues to lobby in favor of less restriction for these drugs?

STACK

10:24:45
Where I think I'd make a distinction from what Barry said is we're talking specifically about the FDA's recent action or recommendation to reschedule hydrocodone from III to II. I think their belief would be, they turn off the spigot, the drugs just go away. We've got the other challenge of treating these 100 million Americans who have chronic pain somehow someway.

STACK

10:25:09
At the same time, we have to balance the addiction problem that's attached to these medications. So we have -- we find that there is not good evidence that rescheduling this will improve the spigot problem, that people will still find ways to have access to these medications for abuse purposes, that we would be better off to focus on educating the patients and the physicians for their appropriate use, having prescription drug monitoring programs used prevalently by physicians to find those patients who are problematic, in undertaking efforts to shut down pill mills.

STACK

10:25:40
Physicians or pharmacies who are, frankly, criminals, they're not practicing medicine. They're pushing drugs, and they should be shut down.

REHM

10:25:45
All right. Dr. Spevak, what's your thought?

SPEVAK

10:25:48
Well, Diane, I think several things. In regard to your comment about the youth, I mean, we know the epidemiologic study, one in 12 high school seniors has abused prescriptions opioids. And we know that the brain is still developing in youth up until the 20s, mid-20s and even late 20s. Short exposure to limited amounts of opioids can cause changes in the brain.

REHM

10:26:14
Even short amounts of it.

SPEVAK

10:26:16
Even short amounts. Recent studies have shown even short amounts. I think that rescheduling is a step in the right direction. Limiting the supply is a step in the right direction. However, realizing from our recent experience with oxycodone -- oxycodone was recently -- the formulation was changed, so it was made less abusable.

SPEVAK

10:26:39
What happened was we saw a spike in the heroin use because people were no longer able to get the effects from oxycodone. So that was unintended consequences of making oxycodone less abusable. So we have to be careful that the same thing doesn't happen now that hydrocodone gets rescheduled.

REHM

10:26:57
I understand you have to be on the lookout for that. But, at the same time, would you agree with the FDA's recommendation to move this drug from a Schedule III to a Schedule II creating more restrictions on use?

SPEVAK

10:27:17
I think balancing all interests -- in this instance, rescheduling it to a Schedule II would be a step in the right direction.

REHM

10:27:25
All right. And, Barry Meier, here is a question that has come up a great deal: "Please" -- and this from Twitter -- "what do you think of the newly approved Zohydro pills?" Barry?

MEIER

10:27:45
Well -- yeah, sure, Diane. Zohydro is a extended-release form of the narcotic hydrocodone, which was used in Vicodin and similar pills. The FDA, against the advice -- the overwhelming advice of its advisory panel, approved this pill a day after last week's decision on the hydrocodone drugs.

REHM

10:28:08
I don't understand how that could happen against a vote of 11-to-2.

MEIER

10:28:16
Well, it's happened on many occasions with this drug problem and this drug issue. With respect to Dr. Stack's comments vis-a-vis the AMA, the board -- the advisory board to the FDA recommended that doctors undergo mandatory training, like, six hours of training, maybe a golf game's time or two in the use of these drugs in order to be able to prescribe them. People like the AMA oppose that decision.

MEIER

10:28:46
So the FDA is free to do what it wants. And, unfortunately, it's also restricted by the law. So if they say to this company, we're not going to approve your drug because these other drugs kind of went wild on the streets, that company probably is very free and may have good grounds to sue the FDA in that, you know, you didn't use the same test to approve our drug that you used to approve these earlier drugs.

REHM

10:29:14
Dr. Stack.

STACK

10:29:15
So I would say that to the point of the education, 20 percent of prescribers prescribe 80 percent or more of the opioids. And a lot of times the problem we see with the states when they pass laws for mandatory continuing medical education is that they mandate 100 percent of physicians do the same type of education, even though it has little to no relevancy for their work. So a radiologist who looks at images, a pathologist who looks at slides has no need to have this particular education where they don't prescribe these medicines.

STACK

10:29:47
So our difference of opinion is not at the high level that education has an appropriate role. It most certainly does. And the AMA has partnered in creating webinars for opioid education, proper prescribing. It's that a one-size-fits-all approach is overly coarse and causes other problems and is not reasonable.

REHM

10:30:04
Dr. Spevak.

SPEVAK

10:30:05
I agree, and I think that the education needs to begin at the medical school level. We've known for a long time now that we've had a lack of good pain management education at the medical school level. So starting at the medical school level, continuing during training, that's where the money is.

REHM

10:30:23
Go ahead, Barry. I know you wanted to jump in.

MEIER

10:30:27
Well, I would only say to Dr. Stack's point that that's sort of a straw man because the only people who would be required to take this training are people that prescribe these drugs...

REHM

10:30:37
I see.

MEIER

10:30:38
...who are DEA license holders to prescribe Class II narcotics. It's not radiologists. It's not psychiatrists. It's not people who do not prescribe these drugs. So I'm a little -- I just don't know what his argument is.

STACK

10:30:54
Diane, may I...

REHM

10:30:55
Sure.

STACK

10:30:55
So, Barry, where I think there's a distinction, this is where actually we're doing this and, you know, delivering the care and having the license. It does color the knowledge of this issue. Many people have DEA numbers as a requirement as part of being credentialed at a hospital or a facility where they may administer medications that are controlled that are not opioids in the hospital-based setting or other settings. So there are many reasons to have a DEA number other than just prescribing outpatient opioid medications.

STACK

10:31:25
And so when we mandate every one of those physicians to take that same education, it's an overly coarse instrument that's not addressing the problem as well as it needs to. So we're not disagreeing about the value of education. It's just that the implementation of the state laws is not as precise as you have made it sound.

REHM

10:31:42
All right. Barry, I want to come back to this question of the 11-to-2 recommendation against Zohydro. I don't understand who made this recommendation and who overruled it.

MEIER

10:32:03
OK. So the FDA relies on -- if they have questions where there may be controversy or they're unclear about how to decide an issue, they will assemble an advisory panel, experts from the field like Dr. Stack or Dr. Spevak, and have 15, 20 people. They make presentations to them. People come in and testify about it. They may hear from the public. And then this panel of experts is supposed to answer certain questions and then ultimately decide their recommendation, to the FDA in this case, whether this drug should be approved or not.

MEIER

10:32:42
Most of the folks on the panel were concerned that this drug would be widely abused, much in the same way that Oxycontin was because essentially it's a similar drug. It just contains hydrocodone instead of Oxycodone. And then that decision goes to the decision makers within the FDA, within the drug center, and they decide.

MEIER

10:33:07
I mean, I had the sense from doing reporting on the hydrocodone decision that there was tremendous differences of opinions within that center as to whether that recommendation to up-schedule the drugs should be made. I asked one of the top officials there, did you agree with this decision? And this gentleman refused to answer that question, which led me to believe that he didn't.

REHM

10:33:29
Interesting. All right. And you're listening to "The Diane Rehm Show." And joining us now from Sacramento, Calif. is Penney Cowan. She's founder of the American Chronic Pain Association. That's a patient advocacy organization. Hello, Penney. Thanks for being with us.

MS. PENNEY COWAN

10:33:56
Good morning, and thank you for having me.

REHM

10:33:58
Tell me your reaction to the FDA recommendation. What are you hearing from your members?

COWAN

10:34:05
Well, obviously from the members, the people who are dependent upon these medications, for many of them, it will be a burden only because of the fact that they're going to have to go to their doctors more often, which means they have to, you know, pay for more appointments. Many of the people with pain are not employed right now. So the money just even to get the gas to go there, to find someone to take them are all issues.

COWAN

10:34:32
But what I want to say -- and I've been listening to the conversation all morning -- is one of the problems is we're always looking at the healthcare providers and the people with pain who are taking these medications. And we even heard Barry Meier say, you know, that 90 percent of the folks after -- before 90 days are up stop taking these. And so the problem has to be bigger than that. And I've heard some talk about education. But I haven't heard much about spreading that education out to the general public. And I think that's really where a lot of the problem is.

COWAN

10:35:06
So, you know, my sense is that everything they've said about educating healthcare providers, I mean, all of those issues are spot on. We need to be able to do more to ensure that less people are harmed. But I think we have to move it beyond just the person with pain and the provider to look who's really, you know, abusing these drugs.

REHM

10:35:29
Yes. And I gather you have fibromyalgia. What's been your own experience with pain management?

COWAN

10:35:38
You know, it's really interesting. I heard them talk about -- both of the physicians talk about it's fairly new to do the interdisciplinary, the multi-modal approach to pain management. However, 34 years ago, I went to a pain management program at the Cleveland Clinic where I had all of those things. For many years -- for the first six years of my pain journey, you know, they tried one thing after another, and nothing worked.

COWAN

10:36:02
And it wasn't until I was in a program where they put all of those components together at the same time -- many that I had tried before that weren't necessarily effective -- that I was actually able to move from that patient back to a functional person again. So it's not new. The problem was -- and we had a multitude of these programs out there. The problem was that they weren't being reimbursed for their services. And it became more focused on prescription and procedures.

COWAN

10:36:31
And I think part of the problem is, you know, that everyone's expectations, especially the person with pain, is just, give me a pill, and I'm fixed. And I think we need to educate people with pain about the whole approach, the total approach to pain management, and that you can live with a certain level of pain. But you have to be taught how to do that. You can still have a quality of life, and you can reduce your sense of suffering and improve your function and increase your -- I mean, improve the quality of life. That's the goal of pain management. It's not to get rid of the pain 100 percent.

REHM

10:37:07
Penney Cowan, she is founder of the American Chronic Pain Association. Thanks so much for joining us. And when we come back, we'll talk further about that whole issue of reimbursement, which may be part of the problem. Stay with us.

REHM

10:40:02
And welcome back. We're talking about the FDA recommendation to tighten the way narcotic painkillers are regulated. Barry Meier, you have said that doctors might not be making a decision based on a patient's needs but rather on reimbursements. Explain what you mean.

MEIER

10:40:28
Well, I think the point that I've been writing about, both at the paper and in my books, is that our medical system is driven by reimbursement. Doctors will only get reimbursed for certain procedures. And about 10 years ago -- Penny Cowan is absolutely right in describing the fact that the techniques of physical therapy, behavior modification used to treat chronic pain were ongoing 25, 30 years ago, and basically got blown out when this huge wave of narcotics prescribing and promotion began.

MEIER

10:41:06
Insurers looked at this and said, this is cheaper. It's much like getting rid of talk therapy for people with depression and putting them on drugs. And it was predicated on the idea that these drugs were safe and effective, which we kind of realize now that they're not exactly such. So, you know, doctors are only getting paid for this.

MEIER

10:41:28
Insurers are only paying for drugs. They're not willing to pay, right now, for alternative treatment. And I guess I keep coming back to the point that this entire situation is not going to change. People can argue themselves blue in the face, that moving a drug here or there will have an impact or won't have an impact, until our method of treating pain changes.

REHM

10:41:51
Indeed.

MEIER

10:41:52
And that's only going to change based on how treatment is reimbursed. And that's why I feel groups like the AMA have an essential role to really advocate on behalf of patients and their overall health, rather than maintaining what Dr. Stack himself acknowledges is a suboptimal treatment.

REHM

10:42:12
All right. I want to open the phones now. Let's go to Deal Island, Md. Hi there, Leigh. You're on the air.

LEIGH

10:42:22
Hello, Diane. Thank you so much for taking my call.

REHM

10:42:24
Indeed. You're welcome.

LEIGH

10:42:26
This may be considered anecdotal. It's my own personal experience. In 1987, I was hurt in an automobile accident. And I have five discs in my back that are herniated along with other bulging discs in my neck and back. It's inoperable. And for the last close to 20 years -- well, the first few years, they tried everything under the sun, from TENS units, electronic stuff to physical therapy, to, you name it, medically with pills.

LEIGH

10:43:07
And the only thing that alleviated my pain and allowed me to have a reasonably normal life was Vicodin, which I get the generic of and have for many years, the hydrocodone. And it's been at least 25 years that I've taken this, 350 milligrams three times a day. Sometimes when there's a storm coming through, where there's a barometric pressure change, I have to take two, but other than that I have had a reasonably normal life.

REHM

10:43:42
All right.

LEIGH

10:43:42
And if not for that, I would not have.

REHM

10:43:44
OK. So, Leigh, just answer this question if you would. How much pain are you suffering even with the oxycodone?

LEIGH

10:43:56
On a level of say one to 10?

REHM

10:43:58
Yes.

LEIGH

10:44:00
About a two.

REHM

10:44:01
OK.

LEIGH

10:44:02
Sometimes a four depending on storms.

REHM

10:44:07
All right.

LEIGH

10:44:08
Because the barometric pressure makes it change.

REHM

10:44:09
OK. And, Dr. Spevak, if these new FDA recommendations do go into effect, how will she be affected?

SPEVAK

10:44:24
Well, I think practically, you know, the good practice of medicine involves seeing your patient regularly, providing a biopsychosocial approach to the treatment of pain. It's not just prescribing the medicines. It's doing all these other things. And now, hopefully, as we switch to a quality-driven reimbursement, to be reimbursed by the quality of care when patients function improves, I think that's going to be the key.

REHM

10:44:52
But, Barry Meier, she's been using this stuff or something like it for 25 years. What's it going to mean for her? Is she going to have a harder time getting hold of it? Is her physician going to be less likely to give her a long-term prescription? Is she one of those people who cannot do without this drug?

MEIER

10:45:21
Well, there are people that take these drugs very successfully, apparently like the caller. And hopefully she won't have major impacts. I mean, if she's still ambulatory, she can get around, she'll just have to visit her doctor four times a year instead of twice a year. And as Dr. Spevak points out, that may in and of itself not be such a bad thing because there may be other issues that arise or other treatments that her doctor can work with her on that may improve her function and abilities even more.

REHM

10:45:56
All right. To Bob in Grand Rapids, Mich., you're on the air.

BOB

10:46:03
Good morning. This is a great discussion.

REHM

10:46:05
Thank you.

BOB

10:46:05
I want to add a couple of suggestions. One, in Michigan we have a service called MAPS. It is a tracking system by which providers can look in -- by the way, I'm a clinical pharmacist. I work in an emergency room. And when people present requesting narcotic refills or something along that line, the providers can look into that system and quickly see if there's any place else and anywhere else that they have picked things up recently.

BOB

10:46:35
And we will be able to immediately see if someone two weeks ago got 90 Vicodins from their primary care doc and are back for, you know, running out, that, you know, they got 20 from an urgent care center 10 miles away and 60 or 90 of them, again, from some place in another part of the state. And it's easier to help identify people that are drug seekers and abusers when you have that tool available versus places where that's not available. So I would like to see something like this nationwide, to help providers identify people with true need a little more easily than drug-seeking and abusers.

REHM

10:47:17
All right. And, Barry, what do you think about that kind of tracking?

MEIER

10:47:21
Well, that kind of tracking has been underway in various states. I mean, the whole effort to get a tracking system started about 12, 15 years ago. It's been spotty. But now most states have it. They do it slightly differently, depending on the classes of drugs that are tracked. But in many places, you know, their doctors don't even look at these systems, you know, when a patient comes in or ignore these systems. You know I think in Florida very recently that state was packed with pill mills.

MEIER

10:47:56
Extraordinary amounts of drugs were being shipped to that state, were being dispensed by pharmacies in that state, and prescriptions were being written by doctors in the state. So you can have these systems in place, but, unless people within the drug production, distribution, prescribing side act properly as well, you know, you're basically burdening the responsible people and not the irresponsible ones.

REHM

10:48:22
Dr. Spevak?

SPEVAK

10:48:24
I agree with Barry and have to add that, for example, as these prescription monitoring programs have grown and have done very well, there have been some states, like Florida, where the legislature has threatened to defund the program because of security breach. The other problems with the programs is there's limited interstate sharing. So places, like here in D.C., we'll go to Virginia, Maryland or D.C. There's limited interstate sharing. These prescription monitoring programs are one part of opioid safety, which involves monitoring opioid agreements with patients and the such.

REHM

10:48:58
All right. And I do want to point out our producer, Rebecca Kaufman, did extend an invitation to the FDA to be present here, to be part of the program. The FDA declined. And let's go to Kristen in Fayetteville, N.Y. Hi, Kristen.

KRISTEN

10:49:23
Hello?

REHM

10:49:26
Yes. You're on the air. Go right ahead.

KRISTEN

10:49:27
Oh, hi, Diane. I love your show.

REHM

10:49:30
Thanks.

KRISTEN

10:49:31
My sister was addicted to oxycodone for a couple of years as a young person, and it ran rampant through our community. When the cops cracked down on the drug dealers and the doctors who were prescribing it, the only thing to satiate these children's addiction was heroin. And so she moved on to that. And after five years, in and out of prison, and having a baby addicted to oxycodone, when I look at it, I see it's less about the people who are in control and more about the people who are addicted to it.

KRISTEN

10:50:10
So finding alternate forms of pain management that aren't opioids and making it almost impossible to get it from anybody but a doctor would really, really help to keep all these young, bright, beautiful people alive.

REHM

10:50:27
I'm sure you both, Dr. Stack and Dr. Spevak, would agree with that.

STACK

10:50:34
Well, you've touched on the tragedy there. And the thing I'd like to point out, in today's reality, right now in this country, 50 million Americans without insurance, 66 million on Medicaid, a third of the country with little to no access to the quality care that Penny talked about, a multidisciplinary approach and then the others who have limited access because behavior health, mental illness and substance dependency is treated as a second-tier illness category in the country and is inappropriately and inadequately funded.

STACK

10:51:04
So the AMA continues to advocate for better funding and treatment options for people who suffer from those maladies.

REHM

10:51:11
All right. To Jake in Lansing, Mich. You're on the air.

JAKE

10:51:16
Hi, Diane.

REHM

10:51:17
Hi, Jake.

JAKE

10:51:20
This is a great show.

REHM

10:51:21
Thanks.

JAKE

10:51:21
I was just kind of wondering what the effects of lobbying and the money in the system tend to play on this because you said 20 percent of the doctors prescribe 80 percent. It seems like that is where the bad actors are. And it would seem like the FDA and the AMA would try and have some sort of a national database to stop these people from going from different states after they've lost their license or they've done something terrible to somebody and they go to another state and they get their license.

JAKE

10:51:50
And, you know, I think that should be the real discussion here. And I think that would really, you know, that the doctors are the bad actors a lot of the times in these cases.

REHM

10:51:57
Barry Meier?

MEIER

10:51:59
Well, I would say that there are doctors who are bad actors. But the number, thankfully, is relatively small. That figure of 20 percent of the doctors prescribing 80 percent of the medications is more reflective of doctors that specialize in pain care, that may treat cancer patients, and they are the people that you may want prescribing these drugs.

MEIER

10:52:19
So that figure in itself is not alarming. As to the issue of lobbying, however, one of the big problems throughout this whole era, if you will, has been that the lobbying has only come from one side. It's come from the drug industry side or from people who are promoting a pharmacology-based treatment.

MEIER

10:52:38
There is little counterforce from the other side, for people who are trying to get alternative treatments to drugs or the types of multidisciplinary programs that Penny talked so eloquently about. So basically you have huge amounts of money, huge amounts of lobbying pouring in from one side and no real advocacy for these other treatments that actually may be better for patients.

REHM

10:53:02
And you're listening to "The Diane Rehm Show." Dr. Spevak?

SPEVAK

10:53:07
And one thing to add on to Barry's comments, hydrocodone is the most prescribed medication in our country. One-hundred and thirty-five million prescriptions a year are written.

REHM

10:53:18
Wow.

STACK

10:53:18
One-hundred and thirty-five million prescriptions. The opioid industry is a $3 billion industry in our country. So I think that has to be kept in mind. We're also here talking about the primary prevention by good pain management, but also the treatment, the treatment of opioid addiction now being one of the ten essential services under the Affordable Care Act.

REHM

10:53:41
So, Barry, what happens next? The recommendation has been made despite what the committee examining this change in status. What happens next?

MEIER

10:53:57
Well, as far as the hydrocodone decision, it basically goes up to the HHS. It appears that they will second that decision. It then goes back to the DEA, which has been pushing for this decision for about a decade. And it goes into effect -- according to FDA officials, they anticipate that it will kick in sometime next year, perhaps in the early part of next year.

REHM

10:54:22
And so what you're saying is that the FDA would not have approved it if they didn't know that the DEA was going to go along with it?

MEIER

10:54:35
Yes. Well, I think more to the point, they would not have approved it if they didn't know that the agency that they report to, Health and Human Services and the Obama administration would not have approved it.

REHM

10:54:48
So finally, Dr. Spevak, what recommendations would you offer to people who say, you know, this is going to mean I have to go see the doctor more often? I've got to check in with the doctor. I may have to drive 40, 50 miles. What are you saying to those people out there who are suffering chronic pain and will now be put through more hoops to get the kind of medication they think will help them?

SPEVAK

10:55:26
I think this is an opportunity to have a discussion with your doctor about all the options that are now there, options that maybe weren't there a year or two ago. The other non-opioid modalities, the behavioral modalities, the physical modalities, the educational activities that are even online now for patients. There are wonderful opportunities online.

REHM

10:55:48
So what the Cleveland Clinic offered to Penny Cowan may be available elsewhere as a change in your relationship toward chronic pain.

SPEVAK

10:56:02
Exactly.

REHM

10:56:03
And how about you, Dr. Stack?

STACK

10:56:06
So I think we just need to know is -- your listeners should understand, as we wind this down, that apart from the chronic pain, this impacts everybody who needs these drugs. So if you slip and break your arm and you see an orthopedic surgeon and you need more pain medication on a Saturday, your only option will be go to an emergency department. If you have an admission to a nursing home who needs acute pain management at nighttime, you may have to be sent by ambulance to an emergency department just to get that treated.

STACK

10:56:35
And if you have your gallbladder removed and you need more pain medication on a Sunday morning -- previously the surgeon on call would cover for that and prescribe you hydrocodone -- you will now have to go to an emergency department because after hours and weekends and holidays there is only one source of care, urgent treatment centers, emergency departments, to have your acute pain managed. That is going to be a big burden.

REHM

10:56:55
Dr. Steven Stack -- he's on the Board of Trustees for the American Medical Association -- Dr. Christopher Spevak of Georgetown University's School of Medicine, Barry Meier -- he's New York Times reporter and author of "Painkiller: A 'Wonder' Drug's Tale of Addiction and Death" -- thank you all so much.

MEIER

10:57:25
Thank you, Diane.

REHM

10:57:26
And thanks for listening, all.

SPEVAK

10:57:27
Thank you, Diane.

REHM

10:57:28
I'm Diane Rehm.
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