Pharmalot: How would you describe your organization? Patenaude: It’s a non-profit with a mission of advancing best practices in medicine. Identifying simple strategies to prevent or reduce medical errors. Something as simple as keeping a medication list or developing ways to make sure that first responders, like police and paramedics, have access to emergency medical information, such as when there’s an accident or acute medical episode. We also look at reducing errors that can occur in dispensing. And we look at logistics at the front and back ends of the supply chain. So, this encompasses more than manufacturing and holding. But by helping to reduce medical errors you can reduce costs. We also provide drug safety research and reporting.
Pharmalot: How did you get started on this path? Patenaude: I was volunteering as a patient advocate. I was helping patients with disability and medical insurance issues, and helping them become better advocates for themselves. Some would go through a medical dispute because they needed access to a medication or therapy. So I had access to a lot of records, including pharmacy records, and some physicians and pharmacists grew to rely on me. But I’m also a patient and sometimes it’s easier for a patient to communicate with another patient. We kind of speak the same language.
Pharmalot: What exactly happened? Patenaude: I have a chronic illness and began having some acute medical complications. And I needed to develop strategies for myself and other patients and doctors began asking me to help them. I guess you could say at that point it became a mission. It really came into focus with a drug shortage that occurred and I traced back issues to a subcontractor and realized by reading their SEC filings I was taking an adulterated injectable drug. And that was followed by a generic Ranbaxy drug I had taken. I had an adverse reaction and was permanently disabled. So that really shifted the focus. This was in 2003... The initial work for PME had actually begun in 2002, although we were awarded non-profit status in 2005 (here are tax returns for 2010, 2009 and 2008).
Pharmalot: So this became personal for you. Patenaude: Yes, I got a Ranbaxy drug and almost immediately, I suffered serious medical complications, but those were originally misdiagnosed. I developed acute dystonia. So I realized these aren’t normal medical complications. This drug didn’t work . And I really regretted it. I thought at first maybe some of these patients (who also experienced side effects) were kind of crazy. But that’s when it hit me. Once it happens to you, it changes everything. So I set out to try to get it off pharmacy shelves so that what happened to me wouldn’t happen to other people.
It was an ‘aha’ moment for me. I realized there wasn’t enough information about drug safety out there and not even many doctors or pharmacists are educated about these issues and how to spot them, identify them and how to report them, and how to try to stop them – and how common they are. There’s a lot to look at and people don’t realize how convoluted the process is before it gets to the patient. It’s a huge system with a lot of potential for errors. We’ve seen the emergence of a gray market now for some drugs. And there are a lot of different issues that can precipitate errors.
Remember that back in 2002, there was a lot of consolidation among drug wholesalers and the big three had secondary market subsidiaries, so there was a lot of arbitrage going on. When a drug is traded and takes a convoluted path to the pharmacy, it can amplify an adulteration problem or become a triggering event for tampering. There was also a wave of manufacturing outsourcing that had begun and a new group of generics coming to market after brand-name drugs lost patent. A lot was happening at once that formed a big problem.
Pharmalot: You mentioned your experience with a Ranbaxy drug, but did you not look at other manufacturers? Patenaude: We tried to identify and keep adulterated Ranbaxy drugs out of patient hands. It was because of my own experience and what I saw that I realized the mistake was right in front of me… but it was not only Ranbaxy drugs. We looked at other drugs made by other manufacturers. But Ranbaxy, I believed, had the potential to become a big problem, and it did… Ranbaxy received their first FDA warning letter in 2002 related to drug application failures for a version of an over-the-counter drug, Guaifenesin, so application issues were made first made public by the FDA in 2002. And in 2004, Ranbaxy was forced to remove their AIDS drugs from the World Health Organization approval list because of faulty drug testing on their WHO drug applications.
Pharmalot: It appears, though, that you’ve focused mostly on generics, is that right? Patenaude: It’s not about taking generic drugs. They’re a great way to cut healthcare costs, but patients are only going to take them and doctors are only going to prescribe them if they’re comfortable that they’re safe. We just want to make sure they’re safe. Brand-name drugs have also been impacted and we’ve looked at those as well. But there’s been a big increase in the rate of generic use. So as a small non-profit with limited resources we put more emphasis and focus on generics. Again, this was during the first wave of new generics and pharmaceutical manufacturer outsourcing. It seemed like a problem that could get much bigger and permeate supplies and have a domino effect.
Pharmalot: Why do you believe a fund is needed? Many people pursue lawsuits. It happens every day. Patenaude: Well, first this was still during era of preemption. And as for me, I was given a two-week life expectancy and when you hear something like that, filing a lawsuit is not foremost on your mind. I knew we had proof of harm. I didn’t how or whether a lawsuit would help and you want to fix the problem. And I knew it would be a huge and evolving problem… The fund is just the next step in helping adulterated drug victims. There aren’t a lot of support resources available for such victims. The Justice Department is going to collect money from Ranbaxy, at some point, I assume, but it’s not clear that any of those funds would be available to individuals.
Pharmalot: And what about others, not just yourself? Patenaude: Patients have insurance and insurance companies have the right to subrogate, which means if a patient files a lawsuit and wins damages, the insurance company can come back and collect their paid claims. With Ranbaxy, at the time of the FDA import alert ban, the FDA stated it was safe for patients to continue taking what were adulterated drugs, which were already in the country. So because of that statement, these patients don’t have a lawsuit. In addition, most patients want to focus on their health and fix the problem and most of the time a lawsuit doesn’t do that. In this case, the fastest way to fix the problem was to get the drugs off the shelves and out of patient hands.
Pharmalot: How many such victims are there, exactly? And how would you know that? Patenaude: There are varying degrees of harm obviously. Not all of the Ranbaxy drugs were adulterated. And some people weren’t really harmed. There may have been a blip. By going public, I estimate there are many more that what I have encountered. I don’t know the exact number. But we identified dozens of suspected cases. And we reported these to state authorities and the FDA, or provided substantiating evidence.
Pharmalot: Some might say ‘She’s just trying to collect money for herself.’ What do you say to that? Patenaude: I'm not. I’m coming forward now in the hope that we can get more support for victims… I’ve never spoken publicly about this before. It’s not about me. It’s about others. I know with the fund, that if we have the resources, we can identify and assist many more.
Pharmalot: Where do you expect to get the money and how much exactly do you think might make a difference? Patenaude: PME is privately funded by individuals and small businesses. Nothing from industry, attorneys or the government. We’d like members of the general public to contribute. I’ve written to the Justice Department and asked about victim status and victim compensation and whether it’s possible to a percentage of the criminal fines in the Ranbaxy case from the expected settlement. A portion would go into a DOJ victims fund. We’re asking for a portion of that to go into the Ranbaxy Victims Fund. And I have pledged that if I receive anything myself, all of it goes back to PME. But we’re hoping to raise $300,000.
Pharmalot: Ranbaxy has been in the news again with the recall of some generic Lipitor. What do you believe this tells the public? Patenaude: It’s unfortunate for everyone, including Ranbaxy, and it tells us that patients should not make assumptions that the drugs they take are always safe. You need to be more aware about what you’re taking and why and, sometimes, whether the manufacturer has a history. It can happen with any company. But as a patient, you have choices and need to become educated. If you’re on a drug and it works, stick with it.