Dose of Digital FDA Pharma Social Media Hearing Testimony - Corrective Information Strategy


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This is my testimony that I will present to the FDA at the upcoming hearings on the use of social communications in pharma. This specifically will address their question regarding "what parameters should apply to the posting of corrective information on Web sites controlled by third parties?"

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  • According to FDA, this is what they are charged with doing (among other things). It’s essentially their mission statement. Of course there are many more details that go into this, but in the end, this is what they’re striving for...important things, of course.
  • When many of the regulations for drug and device promotion were created, most of the technologies we take for granted today, of course, didn’t exist. To illustrate that, I look to look at form 2253, which companies are required to submit each time they create a new piece of promotional material. Despite the fact that this was updated in 2008, there are still 40 different categories of promotional types. 1 of them is called “Internet Promotion” and it’s the single category to lump in promotional activities that account for as much as 25-40% of some brand’s promotional activities. But I think we can all agree that what we have now for regulations are outdated and that’s why we’re here, so I applaud my colleagues at FDA for putting together today’s hearing and recognizing the importance of this. What I want to show today is the consequences that our originally well-intentioned, but now outdated regulations are having on patient health.
  • There’s been a big shift in 10 years since Pew first did this study. The most significant pieces is the big increase in the percentage of people looking for healthcare information online. It’s a dramatic change. Some studies even put this number higher.
  • “ 41% of e-patients have read someone else's commentary or experience about health or medical issues on an online news group, website, or blog.” User generated content plays a major role in what people seek out and find online. That is, they’re finding a lot of content that isn’t created by professionals. Some of this content is accurate and reliable, while other parts are outright false and misleading.
  • And there’s quite a bit for them to find. Nielsen BuzzMetrics tracks more than 1350 sites, blogs, forums, and discussion groups. On average, there are about 83,000 new discussions per day. On WebMD alone, this number is 1,840. Point is, they’ve got a lot to sift through and pharma companies have a lot of areas to track.
  • The level of quality and accuracy of this information is, of course, all over the board. But, does it even matter that people are seeing some of this questionable content? It does, because people aren’t checking the quality of the healthcare information they discover. Too often, they’re taking a lot for granted and placing a lot of trust in places where they probably shouldn’t.
  • It would be one thing if, for all this user generated content and its varying levels of accuracy and quality, people didn’t really pay attention to what they found. But they do. 6 in 10 reported that user-generated content affects their treatment decisions. This content includes everything from blogs, to product and physician reviews, to newsgroups and discussion boards. Why are they turning to this type of information? They are looking for experiences they can relate to. They likely already read a bunch of static articles about their disease and the manufacturer supplied information about certain products, but they’re looking for how it REALLY works from someone who’s been through it. So, this type of content is full of this type of information.
  • When you take all that I’ve said before, you quickly realize that the information that people see online directly impacts their health. The poorer quality information people find, the more likely they’ll make poor choices regarding their health.
  • This statement comes from iGuard. It’s a site where patients can write reviews about the drugs they are receiving. It’s filled with people commenting on how well and how poorly different products work and the side effects they are suffering while on these products. One in particular that caught my eye, having worked in the area of breast cancer for a long time, was this one. She is talking about an adjuvant (after surgery, radiation, and chemo) hormonal treatment for breast cancer called Arimidex. She’s been toughing through what sounds like horrible side effects for two years (you are supposed to take this treatment for at least 5 years as far as we know now). But now, she’s apparently at wits’ end and is literally crying for help. But, no one answers her. What happened to this person? Do you think she continued her treatment and what was the outcome?
  • And even for simple questions in less serious conditions compared to breast cancer. This is a really straightforward question that any doctor, pharmacist or GSK, the maker of Valtrex, could answer in their sleep. But, none of them are “sleeping” so someone else has to step up and answer with a response that included “but I wouldn’t hold my breath.”
  • What role can pharma play to improve the answers to these types of questions? For each of these discussions, I can picture many a physician, nurse, or other healthcare professional putting their head in their hands and shaking it in somewhat disbelief. Right alongside them would be the pharma companies that make these products and could easily answer these questions if they felt that legally they could. And, that’s why we’re all here today.
  • Here’s the debate then: Who is going to answer this question? It’s clear that the companies that host these forums aren’t going to do it for every question (though some provide physicians who do answer some). They don’t have the resources to answer everything and it’s not their job. They’re really creating just the arena for these discussion to take place, so expecting them to answer every question is like expecting the phone company to answer every question someone asks another person during a phone call. Why not this? Why not allow pharma companies to step up and provide a simple answer. Simple answer, right from the package insert. Not a long diatribe of subjective interpretation of clinical studies or why our product is better than a competitors. Just a statement of fact from the approved prescribing information. What’s the harm? To answer that, we have to ask this question: would this have helped this person with their treatment? Probably. They know exactly what they should be doing with their treatment. We improved product safety by answering like this. However, if we follow the letter of the law as it exists today, this would not be allowed. Here, a pharma company discussed a product and an indication which means our answer would have to look like this...
  • It’s 5 pages long and still only answers the same question. Yet, I’m guessing that no one is going to read this and after a company did it a few times on the same discussion board, they’d likely be blocked then banned from these sites. Any engagement in these discussions has to be done within the framework of the existing site. So, if we take away all the fair balance and leave ourselves with this simple one line response, did we improve patient health or put it more at risk? While this is a question for cold sores, which isn’t life threatening, let’s up the stakes a bit. What about our earlier question?
  • Here, the consequences of this person stopping treatment because of a side effect (or any other reason) can be severe. Unfortunately, joint/muscle pain is a common side effect with this class of treatment, but it’s also well-known and well-characterized. For some, this side effect goes away over time. Others have it effectively managed with analgesics. While still others need to be switched to a different treatment class. The worst case scenario is this person stopping all treatment now because she couldn’t get an answer to her question. Of course, we have no way to know if she continued with her treatment or stopped completely. But if we try something different and create an environment where companies can engage and provide objective responses to questions such as these, can we improve public health and help people like this?
  • So, a compromise solution is needed that both sides can agree on. Companies can answer discussions where there is a clear question or inaccurate information is presented – discussions that are about a disease state are off-limits. I’m trying to avoid every time someone says, “I have this problem where...” and 40 companies spring out of the ether to say their product is the best. If there’s inaccurate information or another specific question about your product, only then can you engage. Complete fair balance does not need to be included, but a single (short) consistent response regarding safety should be included – We all know that putting complete fair balance in every answer isn’t practical. These mediums were not made for that purpose, but some safety information is appropriate and a link to more information is also required. Responses can only be based on information included in the current prescribing information – In order to ensure that the debate doesn’t become an interpretation of the finer points of a certain study or delve into off-label areas, companies are only allowed to formulate responses using language from current approved prescribing information. Both FDA and each company worked very hard to get these documents to where they are both satisfied with the result, so why not use it as a guide? If it’s not included in the package insert, you can’t include it in your responses. Companies must provide some way for patients to validate their answer is legitimate – If this concept is approved, you could see some people take advantage of the situation and pose as pharma company representatives who would begin to build credibility as a reliable source. To prevent this, some sort of online identity and answer validation system would need to be included so people could trust the answers are given. All responses are cataloged and shared periodically with FDA – FDA then has a single place to review everything that each company has done. If items are missing, then there are consequences.
  • I mentioned earlier that this person didn’t get an answer to her question and how we have no way to know if she continued with her treatment or stopped completely. But if we try this approach, we could probably help this person. Simply put: Is this short answer seen here more of a risk to public health than letting this person stop their treatment and immediately increase her chances of dying of breast cancer?
  • Dose of Digital FDA Pharma Social Media Hearing Testimony - Corrective Information Strategy

    1. 1. Can a LACK of regulations improve the quality of healthcare information available online? Jonathan Richman Director of Strategic Planning, Bridge Worldwide Author, Dose of Digital
    2. 2. <ul><ul><li>Your Mission: </li></ul></ul><ul><ul><li>“ Advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable.” </li></ul></ul><ul><ul><li>“ Helping the public get the accurate, science-based information they need...” </li></ul></ul>
    4. 4. A Massive Shift <ul><li>2000 </li></ul><ul><li>46% of US adults have Internet access </li></ul><ul><li>5% have broadband access </li></ul><ul><li>25% look online for healthcare information </li></ul><ul><li>2009 </li></ul><ul><li>74% of US adults have Internet access </li></ul><ul><li>57% have broadband access </li></ul><ul><li>61% look online for healthcare information </li></ul>Source: The Social Life of Health Information, Pew Internet, 2009
    5. 5. What They Find 41% Source: The Social Life of Health Information, Pew Internet, 2009
    6. 6. What They Find Source: Nielsen BuzzMetrics, Personal Communications Nielsen BuzzMetrics total Healthcare discussions (~1,350 sites): 82,697 per day 1,840 per day WebMD alone:
    7. 7. So What? <ul><li>“ Three-quarters of health seekers do not consistently check the source and date of the health information they find online.” </li></ul>Source: Online Health Search, Pew Internet, 2006
    8. 8. This Information Has An Influence Source: The Social Life of Health Information, Pew Internet, 2009           User generated content affects treatment decisions
    10. 10. Patients Are Pleading for Quality Advice... The joint/muscle pain is killing me. Can anyone help me?
    11. 11. ...And Need Answers to Simple Questions If I double the dose, would the blisters go away faster? I don’t think there’s any evidence...double your dose and see what happens.
    13. 13. The recommended dosage of VALTREX for treatment of cold sores is 2 grams twice daily for 1 day taken 12 hours apart.
    14. 15. The joint/muscle pain is killing me. Can anyone help me? Longer durations of adjuvant hormonal therapy improve survival versus shorter durations.
    16. 17. A Compromise That Improves Patient Health <ul><li>About your product only </li></ul><ul><li>Short, consistent safety disclaimers </li></ul><ul><li>Current prescribing information is your script </li></ul><ul><li>Validate your answer is legitimate </li></ul><ul><li>Catalog and periodically share with FDA </li></ul>
    17. 18. We'd recommend contacting your physician to discuss this right away.
    18. 19. Let’s find some middle ground and improve the quality of healthcare information available online
    19. 20. Special Thanks <ul><li>Val Jones, M.D., CEO of Better Health, LLC </li></ul><ul><li>Susanna Fox, Pew Internet & American Life Project </li></ul><ul><li>Melissa Davies, Nielsen BuzzMetrics </li></ul><ul><li>Everyone else who provided me with information for this presentation </li></ul>