By Ed Silverman // February 23rd, 2012
For the past few years, the Levaquin antibiotic sold by Johnson & Johnson has caused controversy and angst. The medication, which is part of the fluroquinolone class of drugs, has been linked to severe and lasting tendon damage, and is now the subject of some 2,600 lawsuits moving through federal and state courts. The extent of the litigation and the ensuing publicity over side effects prompted PBS to run a documentary and, recently, an asset management firm that specializes in socially responsible investing submitted a shareholder proposal to J&J in an attempt to force the health care giant to change its approach toward patients who were allegedly injured. A driving force behind these developments has been John Fratti, a former pharmaceutical sales rep who has been trying to convince the health care giant and the FDA to update Levaquin labeling to include a Black Box warning for potentially irreversible peripheral neuropathy. To a certain extent, the agency has been listening – Fratti was invited to speak at a safety workshop and was recently interviewed by agents from the FDA Office of Criminal Investigation. We spoke with him about his plight – he was diagnosed with neurological damage after taking the antibiotic – and his advocacy. This is an excerpt…
Pharmalot: So tell us a little about yourself…
Fratti: I’m 47 and live in Hershey, Pennsylvania. I was a pharmaceutical sales rep from 1998 until 2005, although not for J&J…The first two years, I worked for Wallace Laboratories, and sold cough and cold products… I later worked for PDI Pharmaceuticals.
Pharmalot: When did your odyssey with Levaquin begin?
Fratti: I was prescribed Levaquin by a urologist in 2005… At the time, I had no idea that this or other fluroquinolones could cause such damage… I didn’t think anything of it. It had been on the market since 1997 and I figured it must be safe… I knew it was used for more serious infections, but I knew I would use it for only a short period of time… I took it for 10 days in May 2005 and again for 10 days in August 2005.. Shortly thereafter, I had all kinds of problems – neurological issues, such as my equilibrium was off. My vision was distorted. There were aches and pain. My sleep was disturbed. It got progressively worse. I went to a slew of doctors – neurologists, general practitioner, internal medicine… The symptoms got so bad that I had to leave my job later that year. I eventually went on disability… For most of the past few years, I’ve lived with my parents…
Pharmalot: Meanwhile, you started a blog. What did you hope to accomplish?
Fratti: Yes, it’s called Levaquin Hurts. All these doctors told me it can’t be Levaquin that caused these problems. It has a half life and it’s out of your body in a certain timeframe… I believed them because they’re doctors… So over time I got on the computer and started doing research…
Meanwhile, in 2008 the Black Box warning came out for tendon rupture and tendonitis… but there was nothing about potentially irreversible adverse reactions… I wanted to make a difference in the lives of other people and warn them. It’s not a rare situation and it if was a rare situation, I’d say I was just an lucky guy – like winning the lottery in reverse. I saw a blog called ‘Death by Cipro’ and thought it was a good idea. It’s important to raise awareness about the situation so others don’t become injured.
If I can prevent others from suffering from this toxicity, it makes my life more worthwhile. The symptoms became so horrendous. Other people have been injured by other drugs and have started blogs. Some stick their heads in the sand and don’t want to raise public awareness. And being a former drug rep, I think that lends even more credibility to this issue. But I never envisioned being an activist and didn’t know much about the process and still don’t… I would like to add that there are a lot of other Levaquin advocates out there with blogs. I’m not the only one (here is his blog).
Pharmalot: I understand you spoke at a J&J shareholder meeting. What happened?
Fratti: I bought shares of J&J stock. I did that in 2008, and went to shareholder meeting in April 2009. I bought the stock so I could attend the meeting. What I wanted to do was address the ceo and the board of directors about Levaquin to see if they would put further safety warnings on Levaquin. I figured they wouldn’t do that, but I thought it was something they needed to address. I knew that they knew this was causing a lot of damage to people. I had FOIA reports and knew it linked to a substantial number of safety reports and deaths… I filed the requests with the FDA and the first report showed 14,796 individual safety reports and death outcomescame out to 1,105 between 1997 to 2010… A newer version showed more than 20,000 safety reports and little over 1,100 death outcomes…
Anyway, there were online reports from some fluroquinonlone web sites… It was out there. So I believed this was an issue J&J was well aware of… And there was another individual who had gone to a shareholder meeting in 2008, which was the year before I went, and he had taken a fluroquinonolone and was involved in advocacy… He gave a speech and asked for further safety warnings…
Pharmalot: So did you get to talk at the meeting?
Fratti: Yes, and when I gave my speech, I made sure to be very civil. If I kept it professional, I’d get a better response from shareholders. And they clapped. Many gave me a standing ovation. In the back of my mind, I wanted to try and shame the company. I felt there was a level of greed. They have a credo that’s well known and the first line is responsibility to doctors and nurses and patients and all those who use their products and services. I wanted to challenge them on this. I mentioned the credo several times in my speech. They also say quite a lot in shareholder booklet about caring for the world one patient at a time. Well, at that moment, I was that one patient and I wanted to see what they would do for me.
Pharmalot: Did anyone from J&J respond?
Fratti: After the meeting was over, people started filing out. I was collecting my notes and this guy sat down right next to me and there he was - William Weldon (the J&J ceo). I thought it was a nice gesture. He said he was sorry about what happened to me. He said that we try to make sure our reps inform doctors about such things. I talked a little about my background and what happened to me and I had some Levaquin literature and was in a documentary called ‘Certain Adverse Events,’ which was made about Levaquin toxicity. I gave that to him and he looked me, and I looked at him and he nodded his head and said I’ll look into this and try to help. I figured he was being sincere. He got up and he took that info and left. And we haven’t heard anything from him.
Pharmalot: But you also filed a lawsuit around that time…
Fratti: Yes, it was the same month. My mother wrote him a letter about what happened to me and what I lost in terms of medical expenses and insurance costs. I got a letter back from J&J, but not from Weldon. It was from an attorney saying we’re all sorry about your son and his health problems, but unfortunately, we can’t comment at this time, because your son has filed a lawsuit against us. I just wish I would have heard back from him directly. It was disheartening not to hear back from him in some capacity. But I did file the lawsuit… At the time, I thought he was being sincere by coming over to me. Maybe he was. I also think he was trying to do some damage control in front o f investors and the media. I find that despicable. Maybe it was more of a photo op to minimize damage. But maybe I’ve been through so much I see it differently than someone looking at it from the outside.
Pharmalot: Since then, you’ve been very vocal.
Fratti: I had called PBS and was in contact with them for quite awhile. The producer had some interest (in the topic), but not an overwhelming amount of interest. But when I told her was I appointed as an FDA patient representative, she seemed more interested. I sent her everything and she filmed me in my townhouse (watch the PBS segment here).
Pharmalot: What led you to the investment advisory firm?
Fratti: I wanted a shareholder proposal introduced. And I mentioned there was another person who had purchased over $2,000 worth of stock and that permitted him to submit a proposal. I’m precluded from filing a proposal because I filed a lawsuit. So I contacted Harrington. I was doing some research on foundations involved in corporate responsibility and accountability… And they were floored by the number of lawsuits and said they felt compelled to do something on the issue… I expect the proposal will be dismissed by the SEC, but I want to raise further awareness about this issue. So I guess we’ll see whether it dismissed. To his credit, he was the driving force because he did so much of the work (back story).
Pharmalot: And you say you were recently interviewed by the FDA Office of Criminal Investigation. How did that come about and how did the visit go?
Fratti: I’ve tried contacting many different officials about what I think is deceptive marketing in terms of downplaying safety information. I had contacted nine elected officials from Pennsylvania and they wrote to the FDA about Levaquin and many of them requested further safety warnings for neurological adverse events – central and peripheral – and having a black box warning for the potential irreversible peripheral neuropathy…
Pharmalot: Do you have something to suggest there was criminal wrongdoing?
Fratti: Well, the agents were very interested in reviewing my documents. And I spent a lot of time over the past few weeks preparing for the meeting. I put together separate folders with documentation about my pharmaceutical background, JNJ clinical trials, FDA documentation, medical articles on Levaquin toxicity, letters from elected officials, information on the Levaquin and the Omnicare fiasco, Levaquin FOI Reports, information on off-label reports, a letter from a former JNJ Brand Manager, the result of the first Levaquin trial, adverse events (see his pie chart) and a lot of other documentation. They went through most of the information. They were really surprised at the extent of damage from Levaquin and fluoroquinolones, in general. They seem to agree that there is a true lack of access to the fine print warning that Levaquin can cause irreversible neurological disorders.
They were here for several hours, not including a lunch break where I had to rest. They reviewed everything that I gathered about medical studies… They asked if I had any information concerning J&J sales reps and their interactions with doctors. That is something that I’m in the process of attempting to get… They didn’t describe this as part of an investigation. They said it was an open case… They asked me who I feel is at fault on this issue: the FDA, JNJ, or both. I stated I felt both. The FDA has been negligent and JNJ has not provided proper safety information to both physicians and
[EDITOR’S NOTE: We contacted the FDA and a spokeswoman would only say the agency does not comment on potential open cases.]
Pharmalot: You mentioned you showed them information about clinical trials. What are you referring to?
Fratti: There were four trials submitted by Johnson & Johnson to the FDA for approval in 1996 that were considered significantly flawed and that’s on the FDA web site. There were significant flaws in protocol design and implementation… This language is repeated by FDA reviewers several times. Clearly, there were problems at an early stage… This is why I think the FDA should be accountable, too. The agency was aware (of problems).
[EDITOR'S NOTE: A J&J spokesman writes to say the totality of the clinical evidence should be considered. You can read the FDA documents here; click on Part 2].
As for J&J, I know, by and large, that industry reps sometimes downplay risk information and use deceptive marketing practices. Maybe upper management is not giving the full range of side effects disclosure to their reps and not being forthcoming with the side effect profile… They have a poor track record when it comes to product safety. Look at the hip implants. But I think there were a lot of people complicit in this.
Pharmalot: At the end of the day, what do you want to see happen?
Fratti: I do not feel that Levaquin should be taken off the market. It serves a useful purpose for treating life-threatening infections. It needs to be reserved as a last line of defense, but not as a first-line treatment for common routine infections. Roughly half of the fluoroquinolones that were once on the market have already been taken off the market. J&J marketed this antibiotic recklessly and for simple routine infections. There are many other classes of antibiotics that can be used in those situations. This will also serve to limit bacterial resistance.
I feel the Levaquin pharmacy handout information sheet, which is different than the label, should note that Levaquin may cause prolonged and delayed central nervous system disorders. It is key that the words prolonged and delayed be included. More important, I feel that a black box warning for potential irreversible peripheral neuropathy should be placed on both the label and the pharmacy handout. If irreversible peripheral neuropathy is listed on the label, which consumers don’t receive, it should also be listed on the pharmacy handout sheet. It is vital that consumers are adequately informed of potential prolonged, delayed, and irreversible disorders. A boxed warning for potential irreversible neuropathy is a must. (And) I feel there should be Dear Doctor letters sent out… I also feel the FDA should hold an advisory committee meeting on Levaquin toxicity and that there be a Risk Evaluation and Mitigation Strategy for potential irreversible peripheral neuropathy.
The sad reality is that nobody really gives a damn about this unless it happens to them or a family member. Thousands of us that are suffering are just a bunch of faceless statistics.
fratti pic thx to pbs