Thank you.
Bonjour. I am Craig Landau, and I want to thank the committee for the opportunity to appear.
I am the president of Purdue Pharma here in Canada. I've held this position for four months. I am new to the country and I'm also new to the company. l'm also a physician. I'm an anesthesiologist and a pain doctor, to be exact. l've treated hundreds, if not thousands, of patients in multiple settings—the civilian setting, including the academic environment; and also the United States military, in the army, where I was part of a combat support hospital providing services in support of the previous and/or ongoing conflicts in both Afghanistan and Iraq.
As an aside, long before coming to Canada, I had the privilege of serving alongside and training with a number of my counterparts from Canada in military medicine.
l've treated patients in pain, and l've dealt with the consequences, both good and bad, so I have an understanding of the benefit and the harm that come from using medications intended to treat patients. I know that abuse and its consequences at the individual level, at the family level, and at the societal level are devastating.
As the president of a company that develops and brings pain medicines to market, it might seem odd in some respects to hear me agree with my counterparts on the video conference. As a pain doctor it's my belief that in certain cases opioids in particular are over-prescribed. They're often prescribed for inappropriate conditions. That tells me we all have a lot of work to do.
That said, and to state the obvious, I do represent a company and I can't remove my affiliation. We're a company, and like any other business, we need the ink on our ledger to be black and not red. We need to do that because we employ just about 400 people in both Pickering, Ontario, and across the country. We need the ink to be black because we're in the business of developing medicines that require a substantial investment, and those medicines are intended to benefit patients and provide a public health benefit.
I'm encouraged that earlier in the week the federal government delivered an economic action plan in the House of Commons. It's my understanding that this plan will expand the focus on drug abuse from illicit drug abuse to abuse of prescription medicines, and I think that's just fantastic. We can't stress enough and can't educate enough at all levels things such as safe use, proper storage, and proper disposal of medicines that carry this risk.
I know, and many organizations with learned individuals know, that medications, opioids in particular, that fall into the wrong hands and that are abused and misused often come from the very medicine cabinet of a legitimate patient who is seen in a doctor's office. We need to do something about that.
With that, I applaud the efforts of this committee. I congratulate those here in Ottawa and across the provinces who have already taken action on this issue.
For the remainder of my time, I intend to offer as a resource my company's experience with OxyContin, with a product developed to address a specific vulnerability, OxyNEO, and to share how we went about doing that, how we worked with the regulators, particularly in the United States where I come from, and then of course to answer questions.
I'm happy to take questions about my company, about what we've done, but it's my view we're here to discuss prescription drug abuse. This isn't a single company issue. It's not a single product issue. It's a public health issue. As a pretty high-ranking official at the U.S. FDA refers to it, it's a public health crisis.
Before coming to Canada in September of last year, I was the chief medical officer at Purdue in the United States, a position I held for roughly five years. I headed clinical development. Most of my responsibility was to oversee the development of opioid medications that were designed to be safe and effective for patients, but that would also have another benefit—they would be less attractive as drugs of abuse. One of those products is actually OxyNEO here in Canada. We still refer to it as OxyContin in the United States, because we determined the recognition associated with that name would have doctors retain the state of awareness for how careful one needs to be in prescribing it to patients.
The product it replaced—OxyContin, which has been referred to already—was deemed by Health Canada, the U.S. FDA, and many other health authorities around the world as safe and effective when prescribed to appropriate patients and when used as directed. It delivered medicine, oxycodone, as an active ingredient over 12 hours.
It really did revolutionize, from a practitioner's perspective, the treatment of pain for folks with cancer pain and non-cancer pain that was chronic, moderate, or severe in nature. It allowed patients who had previously been taking oral medication four, six, or eight times a day to take it twice a day. That's pretty meaningful if you suffer from chronic pain. Fortunately, I'm not a chronic pain patient myself.
While the medicine was safe and effective, it did have an Achilles heel, a specific vulnerability. The vulnerability that we didn't anticipate, that could track and lead to the type of abuse and outcomes that we heard about just a few minutes ago, was that it could be easily crushed. Within a matter of seconds, one could, under this glass or between two spoons, crush this pill and access 12 hours' worth of opioid pain medicine. Intended for delivery over 12 hours, it could be readily accessible.
To abusers who were seeking an opioid, that was terrific. To patients, thankfully far less often than abusers, it could also mean a bad outcome. Some patients—we have a record—in need of pain control here and now would on occasion chew the medicine to get pain relief more quickly than they would receive if they swallowed an intact tablet. As well, without knowledge, when an otherwise well-intentioned caregiver in an institutional setting would crush a tablet and administer it through a nasogastric tube, or an orogastric tube, because patients were unable to swallow medicines, bad outcomes would occur.
Before getting into OxyNEO, and certainly before concluding my remarks, I want to make four points for context. First, as I'm speaking about abuse-deterrent formulations, or ADFs, and the movement from OxyContin to another product, OxyNEO, I want to make the point that abuse-deterrent formulations are not a silver bullet. Abuse and addiction are very complicated matters. They're multifactorial. There are sociological, economic, behavioural, and genetic components that need to be approached from multiple dimensions.
Second, abuse-deterrent formulations are just that: intended to deter abuse, not eliminate abuse. There's no technology available to us today—to Purdue or any other company, large or small—that is abuse-proof or that is abuse-resistant. The idea is to create a barrier and to send the folks who would otherwise abuse this product somewhere else.
Third, abuse-deterrent formulations are an incremental but essential improvement on products that have been around for a very long time. Companies like Purdue can and should pursue them.
Fourth, abuse deterrence isn't a branded versus generic drug industry issue. I'd like to say that again. It's not a branded versus generic issue. Branded and generic companies have technology and laboratories available to them, and both parts of the industry should be pursuing this. This is about public health.
OxyNEO, like most medications, was designed for patients. The benefits of making them safer for patients are obvious. On the abuse side, the benefits of making them less attractive to abusers are less obvious. But if a product is less attractive to abusers, it could mean less doctor-shopping, less diversion, and less theft or criminal activities related to obtaining it. Certainly, with those less affected, it means less emotional, societal, and financial burden associated with abuse.
We formulated OxyNEO specifically to address two routes of administration that are particularly harmful and particularly attractive, especially to those who prefer opioids for a long time—intranasal abuse and intravenous abuse, two particularly dangerous routes of administration. With a different excipient and a unique manufacturing process, we were able to make these tablets, which had been easy to crush, very hard, very difficult to crush, and very difficult to reduce to smaller particles for the purposes of swallowing, snorting, smoking, or injecting.
It took my company nine years. We started this exercise in 2001 or thereabouts. It took us nine years. We pursued four or five different drug-delivery platforms, spent many hundreds of millions of dollars, particularly in the United States, until in 2005 we came upon this technology that would allow us to replace the OxyContin product with one that would be equally safe and effective for patients. It would be therapeutically interchangeable, but have this added benefit of being more robust to manipulation, whether it be for the purpose of intentional abuse or inadvertent misuse by patients.
What did we learn? In August 2010 we transitioned the United States market, and most of our experience is from the United States because it happened earlier there. We've learned a lot. We've learned that while the product can and is still being abused—and I want to be clear about that—abuse has gone way down relative to the abuse we saw with the original OxyContin product, particularly because it's difficult to crush, it's difficult to snort, and it's difficult to inject.
Yes?
