Bob Bianchi is the President and Chief of Scientific and Technical Affairs at the Prescription Drug Research Center in Bradenton FL. Mr. Bianchi retired as a forensic analytical chemist from the Drug Enforcement Administration (DEA) after 34 years of federal service, where he held increasingly responsible positions as an analytical chemist for the FDA and DEA to the chief of DEA’s Laboratory Operations Section. Mr. Bianchi was also Director of the DEA Special Testing and Research Laboratory where extractability experiments were conducted more than twenty years ago. Since 2005 he has been working with the pharmaceutical industry on developing in vitro protocols to evaluate abuse-deterrent formulations and has been actively involved in sharing his experience with the regulatory, pharmaceutical, law enforcement and drug abuse communities. Mr. Bianchi is also a Special Government Employee for participation in the FDA Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee meetings.
Joe Lavelle: Hello this is Joe Lavelle your host of intrepid Healthcare, we are about to bring you one of two special interviews that we’ve conducted on the opioid crisis. Thank you so much to the great folks at NMS Labs for connecting us with Bob Bianchi and for helping us to make this interview happen.
Bob Bianchi is the President and Chief of Scientific and Technical Affairs at the Prescription Drug Research Center in Bradenton, Florida. Mr. Bianchi retired as a forensic analytics chemist from The Drug Enforcement Agency after 34 years of federal service where he held increasingly responsible positions as an analytical chemist for the FDA and the DEA to the chief of DEA laboratory’s operation section.
Mr. Bianchi was also a Director of the DEA Special Testing and Research Laboratory where extractability experiments were conducted more than 20 years ago. Since 2005 he has been working with a pharmaceutical industry on developing in-vitro protocols to evaluate abuse deterrent formulations and has been actively involved in sharing his experience with regulatory, pharmaceutical, law enforcement and drug abuse communities. Mr. Bianchi is also a special government employee for participation in FDA’s Anesthetic and Life Support Drugs Advisory Committee, and the Drug Safety and Risk Management Advisory Committee meetings. Please go to www.nmslabs.com and see what other great things that folks of NMS Labs are doing in addition to help fight the opioid crisis, and now here’s our show.
Joe Lavelle: Welcome back to Intrepid Healthcare, I’m your host Joe Lavelle and I’m really looking forward to this conversation with another trail blazing innovator. We’re going to get right to it today. We’re joined by Bob Bianchi, President and Chief of Scientific and Technical Affairs at the Prescription Drug Research Center. Bob, welcome to the show.
Robert Bianchi: Good morning Joe, thank you for having me.
Joe Lavelle: Well, thank you for being on the show. Bob, will you take a couple of minutes and tell the audience what you do in your role at the Prescription Drug Research Center?
Robert Bianchi: Sure. I am a chemist and I have been working with the Prescription Drug Research Center for about 10 years, trying to help the pharmaceutical industry develop new and innovative formulations to deter abuse, worked with a number of the major pharmaceutical companies as well as some small companies that are developing some of these techniques. I have also worked with the FDA and have various groups that are trying to develop protocols for the procedures to demonstrate that a particular formulation does have abuse-deterrent properties.
Joe Lavelle: Well Bob, we don’t have to look far in the news to figure out that the opioid crisis is a real problem in the United States, could you start by sharing some of the factors that have contributed to the growing problem?
Robert Bianchi: One of the things that we need to put right out front is that this is really a very complex issue, and there are many contributing factors, and there is no simple fix. When people like to find a silver bullet that can make things better, such a thing does not exist. But we are in a kind of an unusual set of circumstances in the United States where we’re consuming 80% of the world’s supply of pain medications, and we only represent about 5% of the total world population. The sale of opioids is a very attractive revenue stream in 2015 that accounted for 30 billion dollars’ worth of sales, so everybody is looking to that as an opportunity to make some money. Now the CDC estimates that drug overdose, that’s in 2015, was approximately 52,400 people, that’s a 144 per day, and of those prescription drugs accounted for 20,000 or 55 people per day, and of those prescription drugs, opioids accounted for 15,000 or 44 people dying every day throughout the United States.
Now, it’s a kind of an interesting twist from the illegal opioids or heroin for example and fentanyl, but people view prescription drugs as being safe, they are approved by the FDA, they are taken by family members and friends, they are prescribed by doctors, how bad could it be, but we know now that it’s really bad, and most of the people that are starting with prescription drugs are getting them from family or friends, and half of them are not paying for them, they are free, so you can see how easy it is for somebody to become sucked into this lifestyle.
The FDA and the DEA have worked together to try to control distribution, use and misuse of pharmaceuticals, and most recently you might have seen an article in the Washington Post or on 60 Minutes about a former DEA employee by the name of Joe Rannazzisi. Now I know Joe personally, so I can talk a little bit about him. He was the person in charge of the Office of Diversion Control for the DEA, the Watch Dog for DEA over prescription drugs. Joe is a very dedicated federal employee who is trying to do the best that he can to fulfill the mission of the agency.
So, I have a lot of respect for him, and I talked and worked with him over the years, and he comes across as a very strong positive person. He most recently talked about a law that was enacted in 2016, that kind of tied his hands, in the past if a distributor was fulfilling a suspicious order, they were obligated to notify the DEA, and if the DEA knew that such activity was going on, the distributor would get a notice and say, hey stop selling to that particular network. So, the law restricted DEA’s ability to do that where they had to provide evidence that there was a substantial likelihood of an immediate threat, to which is almost an impossible hurdle to achieve.
So in essence DEA was not doing the sanctions that they have been doing in the past, and Joe has retired and felt that he needed to get this information out into the community, and I think that’s a very important bit of information that everybody should be aware of, that these things are actually happening today.
Joe Lavelle: Those are just amazing facts, thanks for sharing those. Why do you think prescription drug abuse is such a rapidly growing problem right now?
Robert Bianchi: Well, we’re kind of a unique society that we don’t want to endure any discomfort or pain of any kind, and it’s very easy for somebody to ask a doctor for some kind of a medication to take care or whatever ails them. And you see ads on TV all the time about taking various medications, the industry has spent 4.8 billion dollars in 2016 on TV advertising, and it’s interesting to note that there are only two countries in the world that permit direct consumer advertising, of course the United States is one and New Zealand is the other. So, we have become a very chemical dependent society, and we have a feel to fix just about everything.
We’re also having some issues with pharmacy thefts. In some of my research I was amazed to learn that half of the pharmacy thefts are being perpetrated by employees, the other half are break ins and a small portion of armed robberies, and that is what most people think of when you talk about pharmacy theft. So, they’re inside jobs half the time. So, we have a whole medicine cabinet full of different types of opioids, but the most common that are being abused are methadone, oxycodone and hydrocodone.
Joe Lavelle: I think you’re right, I think the US, we often just want to go to a doctor and we’ve made it easier and easier to go to a doctor in a box to go somewhere with the idea that we will just get some magic thing in a tablet that will make us feel better. Do you think we’re doing enough to ensure the appropriate use of prescription drugs that have high abuse potential, like the drugs you just mentioned?
Robert Bianchi: Yeah, we know from various studies that the more prescriptions that are written the higher the abuse of opioids, and in 2012 there were 259 million prescriptions written for opioids, and many of them wind up in somebody’s medicine cabinet, I know if you look in my medicine cabinet, I’ve got some opioids that I was prescribed for pain at some time but kept it just in case. So those drugs are available to go out into the marketplace, which is a real, real big problem. We need to do a better job of educating both the patients and the physicians that are prescribing these meds, the doctors that are writing the prescriptions depend for the most part on sales representatives from various companies to tell them about new and innovative products.
So, in answer to your question in one word, no, we’re not doing enough, we need to do more, we need to do a better job of educating our people.
Joe Lavelle: And it says all stages, right? It’s at those drug reps, it’s at the emergency room when the doctor’s prescribing or in the office, it’s all the way along the process. I’m in the same boat as you, I’ve got a couple of different prescriptions from 1 year ago and four years ago where I had three pills left, how do we educate patients what to do with those? I don’t want to throw them away, but if there was a convenient way for me to throw them away, I probably would.
Robert Bianchi: Yeah, we’ll talk about that in a minute. But there is a mechanism to dispose of them, flushing them down in the drain is really not acceptable anymore.
I had a conversation with my GP about this whole issue of writing prescriptions for opioids, and he said very candidly when patients come into see him, they expect to leave with a magic pill, something that’s going to fix their ailment, whatever it is, and medicine is not a very exact science and sometimes you don’t have the answer to your problem, but if you give them a prescription they feel much better, so it’s easier for a doctor to do that than it is to try to convince them that that is not the answer, that we need to look at other alternatives before, and the alternatives could be things like rehab or exercise or things like that, but we just don’t want to experience any discomfort and we want immediate relief and the doctors oblige.
Joe Lavelle: Right. Bob, how has the Federal government responded to the growing opioid epidemic?
Robert Bianchi: There are many elements of the federal government that are involved in this thing, certainly the CDC and MIRE, and FDA and DEA are prominent players, and I think that what is happening now is being driven by a recognition that we do have an opioid epidemic as announced by the CDC, the President has announced that we have an opioid emergency, and we need to do something about it, so as I said earlier there’s no quick fix, so we take in incremental steps.
And one of the things that the FDA has done and I saw this while I was at the DEA as well, as trying to encourage manufacturers to produce products that could not be easily abused. So, the FDA is encouraging and incentivizing the pharmaceutical industry to develop formulations that have abused deterrent properties, so that’s the biggie, that’s what FDA is doing and that suits right now on the landscape.
In 2015, the FDA issued guidance to industry on how to demonstrate that a formulation is a truly abused deterrent, and those were laboratory studies that needed to be done, and the FDA also encouraged the use of independent labs such as NMS Laboratories to conduct a non-bias studies. All of the sponsors have the in house capability to do the testing, but the FDA feels that it should be done by an independent laboratory. So, that’s created a whole new business model. We’re also increasing our monitoring and investigations of the manufacturers, distributors, the pharmacies and physicians, and even the practices of some of the insurance companies to limit access to opioids, and the CDC issued some guidelines about the number that should be prescribed at any one time, and they’re also recommending trying alternative means first, and they have gotten some push back and the medical industry is saying, don’t tell us how to practice medicine, so it’s a difficult situation.
And the federal agencies are easy targets, everybody likes to point to them and say hey, they didn’t do what they were supposed to do. Just about all of the States have prescription drug monitoring programs where they monitor the distribution of controlled substances, so that a physician or a pharmacist can go to his database and see if a particular patient has seeing multiple doctors for the same prescription. Definitely a tip off that they are abusing them and they have the authority to refuse to fill a prescription.
Going back your comment earlier about having pills in your medicine cabinet just in case. DEA started a program about 7 years ago called the Take Back Program, and you can bring any prescription to a collection site. They do it twice a year, it was originally only DEA facilities, but now it has gone into police departments and pharmacies, but the metrics are absolutely incredible. This past April, the Take Back Program received 450 tons, tons, of prescription drugs, and since the program has been in inception, the DEA calculates that they have received 2,789 tons of prescription drugs.
Incredible, absolutely incredible. So, I also think that we need to a better job of educating, particularly our young people on the hazards of experimenting with drugs. Unfortunately we don’t really have a very visible presence in that arena. I always liked the “just say no to drugs” and the partnership for drug free America which show an egg being cooked in a frying pan and say this is your brain on drugs, I think that we need to get back into messages like that, we need to talk about it in schools, and we need to make sure that our children understand the hazards before they’re exposed to it and I don’t think we’ve been doing a good job. Our parents are not that well educated. It’s kind of a situation where we need to muster our resources and come up with programs to help educate our kids.
The other area that has been problematic are the pill mills or pain clinics, and Florida was the epicenter for pill mills in the recent past. And people were coming from all over the adjoining states just to see one of these doctors and I’ll call them what they are, bad doctors, that are writing prescriptions, not do any examinations of any kind, for people that what was obviously dependent, for people that needed the drugs to relieve their symptoms, and it was a cash business. There was no Medicare, no insurance companies, cash on the line. So the attorney general at the time saw this as a challenge and she initiated some activities that reduced the number of pain clinics by about 50%, which is a great improvement, but there are still several hundred operating in the state and there’s only so much you can do. Resources are limited, manpower and money, so you try to attack problems as they raise their ugly heads.
One of the other things that the FDA has done is increase the use of advisory committees. The FDA is staffed was thousands of professionals, pharmacists, chemists that are evaluating the new drug applications for eventual distribution in the network, so the FDA still feels the need to have some outside consultants or experts help them in making these decision processes. So for opioids all of them are going to go before advisory committees, and the advisory committees are made up of approximately 18 experts in various fields of medicine and drug abuse, that will listen to the evidence presented by the sponsors, the evidence presented by the FDA and then make a recommendation to the FDA as to whether or not that particular formulation should be approved. And the FDA is not bound to accept the recommendation, but they do in about 75% of the cases.
Now in March of this year, there was an advisory committee meeting to look at the benefits of reformulated Opana and they decided that the risk of intravenous injection is so great that they recommended that it not be allowed to be sold, and 2 months later the FDA asked Opana to remove it and they did comply, which was great.
Joe Lavelle: Bob, I understand that these advisory committees, expanding the use of the advisory committees was part of a FDA action plan that was released last year, last February, what other things were included in that action plan?
Robert Bianchi: The FDA has really taken the lead on this, they are using their advisory committees almost exclusively, we’re talking about primarily opioids, but they are trying to develop warnings and safety information that appears on the labels or the product information sheet, so that both the doctors and the patients are aware of the risks. Unfortunately, if you’ve got a prescription in a recent past, you get this multi-page document in very, very fine print that most people don’t read.
That’s the only mechanism that you really have, that and the Physician. So, the FDA is also going to be strengthening some of their post-marketing requirements to see if these new formulations are in fact reducing abuse. We don’t have a whole lot of data on that, and that is part of their REMS Program where they are trying to mitigate the abuse, and one of the ways to do that is to see what’s going on in the street. And in most cases the emergency department or the crime laboratory does not report by brand name. They’ll usually report as oxycodone or hydrocodone and don’t give the brand name, so it’s going to be difficult to capture that information, but we need to try to do it and do the best we can.
So, I think that we need to do a lot of things to expand access to these abuse-deterrent formulations and unfortunately it costs money to make these new formulations, and the FDA is trying to encourage people to develop generic formulations that also have abuse-deterrent formulations. And there may be a day when the only opioid you’re going to be able to get will have some abuse-deterrent properties, but right now that is not the case. They’re both on the market and I think that slowly the non-abuse deterrent formulations are going to be taken off the market, and it is a big market. There is a lot money to be made and there are a lot of players in this.
We also need to look at treatment for the people that are addicted. How can we better satisfy the needs for people that are caught in this trap? And ideally it would be great if we had a formulation that was non-addictive and relieved pain. That would be the gold standard, if an innovator could develop such a formulation that will go a long way to alleviate in this opioid epidemic that is getting worse every single day. Unfortunately, one of the unintended consequences of these formulations that make abuse more difficult is that the abusers will go to another formulation or heroin.
Heroin has been around for decades, we’ve been fighting this battle forever. It’s inexpensive, it’s readily available, provides the same type of euphoria that you get from the prescription drugs, and we’re right now facing a very dangerous introduction to the heroin market and that’s the addition of fentanyl and fentanyl analogues, which are much more potent than heroin, present in much smaller quantities, but still causing overdose and death. So, it’s a difficult complex situation that we’re in, that’s going to require cooperation from industry and government. It’s not anybody’s fault, people like to point fingers, but we’re in it up to our necks and we need to start doing things, and I think that once we recognize this and start putting resources into it, we’re going to mitigate it, but it’s not going to go away completely.
Joe Lavelle: Bob, you’ve done just a fantastic job providing great statistics and great background of how we got to here. Obviously we’re early on in this battle versus the crisis, what can and should we be doing in the next year or so from a government level, from a programs level to accelerate our battle against the opioid crisis?
Robert Bianchi: Well, the number one initiative would be to fund these programs that will help educate people, to help those that need help, those that are in need of treatment. And we need to be more aware of it as parents and not say this will not happen in my community. It crossed all economic lines, all racial lines, everybody, it’s an equal opportunity drug. So I think we need to have that conversation in the schools with the kids and start at early age. Unfortunately and I don’t want to belabor this point, but we’re dealing with a situation with marijuana that is exacerbating this whole opioid addiction.
And many states have approved the use of medical marijuana, and there is evidence that some of the alkaloids in marijuana plants are helpful, But now some of the states have approved marijuana for recreational use, and I think that’s a slippery slope. And many people will say, well, I know people that have used marijuana and never went onto any other drug and that’s true, there are many people will refer to marijuana it’s a gateway drug, but there are studies that have demonstrated that people that have become addicted to opioids including heroin and prescription drugs initially were abusing marijuana in that respect as a gateway drug.
I think that we need to get our act together and recognize this and do something about it throughout all of our communities, it’s not just an urban problem, it is all over.
Joe Lavelle: Bob, it was such a great pleasure to have you on the show, thanks for stopping by and framing the problem and some of the solutions with us.
Robert Bianchi: It was great Joe and I appreciate the opportunity to share my thoughts.
Joe Lavelle: It’s totally our please and that wraps this broadcast. On behalf of our guest, Bob Bianchi, I am Joe Lavelle, and we’ll see you soon on Intrepid Healthcare.