Archive | January, 2009
Jan 29th 2009 

FDA Isn’t Ready For Us…Stop All E-Marketing!

I’ve been preaching a bit on this blog about how we have to try to use new digital technologies in healthcare marketing (particularly pharma) . I’ve also tried to show that it is possible to do use these technologies in a regulatory compliant way…at least for some things.

But I’ve realized one thing lately. Yes, there are a lot of companies whose internal processes or culture make it extremely difficult to try out some of these new ideas. I’ve considered this situation and the lack of willingness to break this trend to be the fault of healthcare marketers. However, I realize that I may have been too harsh. In fact, they share the blame.

The reality is that you really cannot do anything promotional in the US without the blessing of the FDA (specifically DDMAC). You even have to pre-clear some materials with them before you use it including DTC TV. You are required to submit a “2253″ and you have to do this “at the time of initial publication or dissemination.” You really have to see a “2253″ to appreciate it. Get yours here and follow along.

As far as government forms go, this one isn’t that bad. But you need to do this for every promotional item you create. It’s simple when it’s a printed core visual aid or a print ad, but what about when it’s a blog? John Mack had a good comment about this on a recent post that sort of wonders aloud if each post of blog post (and/or each comment) would have to be submitted with a new 2253. That would be a pretty colossal waste of time and obviously doesn’t quite fit with the immediacy that we have come to expect from blogs. It’s also a nice deterrent to starting a company blog.

Here’s where I’m going with this. Take a quick look at the 3rd page of the 2253. It includes a list of all the codes of the different promotional channels and materials that can be submitted. This is supposed to be an all encompassing list to ensure you use the right code (it’s the government…gotta have a code). Some of the things on the list are pretty standard including print ads, direct mail, samples, and exhibit panels. But the list also includes such ancient items as “Professional Price Catalogues,” “Professional File Card,”  and “Professional Computer Disks/Programs/CD-ROM.” Hi. Welcome to 1996. Disks and CD-ROMs. Really? I remember these things from my first days in the field as a sales rep 13 years ago. Is anyone still using these? The list also includes extinct items like “Professional Giveaways.” Of course, my favorite listing, with FDA showing off its 1950s sensibilities, is “Professional House Organ.” Who among us, born after 1970, knows what this is without using Google? Please let me know. Certainly it leaves an active imagination to come up with some explanations.

All of these taken together amount to 40 different categories. Only one of these is related to “The Internets.” “WWW” is reserved for “Internet Promotion.” That’s right, everything related to any activity online goes into this bucket. Now, considering all of the different categories, which one do you think gets the most number of submissions? Without any actual data, I’m going to guess that “WWW” is the most popular when you consider, for example, online display ads, email, and websites. Yet, even these three aren’t seperated or warrant their own category. I often wonder if there is one person at FDA who knows how to use “The Computer” who reviews all of this stuff. If it’s got a “WWW” on the 2253, it just goes over to Ted in IT for a quick look.

I joke a bit, but this tells me that the FDA isn’t ready for us. Consider what it would take to review a single banner ad versus a social networking site or a 100 page website. Yet, they are lumped together. There are much different rules for each and different levels of scrutiny applied. The question is: does FDA even know this is an issue? Who is the expert there on digital marketing who can help set the next generation of rules and regulations so that healthcare marketing can catch up to the rest of the world? I’ve talked about this lack of expertise being an issue in some of the healthcare companies themselves, but hadn’t considered that it might even be worse at FDA. Who’s teaching them? They don’t have a digital agency that can keep them up to date on trends and who has a vested interest in ensuring that they are.

So, here’s what I propose and what you’ll seen in the coming weeks: We need nothing short of a new set of rules and guidelines for digital marketing in healthcare. FDA needs to adopt these new rules right away. Why? It’s a plus for everyone. It ensures the following:

  • Patients and physicians can get better, more up to date information, in the forms they want.
  • Healthcare companies can use the channels their customers are demanding and move away from interuptive promotional channels like DTC TV. Costs go down, effectiveness goes up.
  • FDA gets everyone on the same page with the rules. It eliminates gray areas about what’s allowed and what’s not with a channel like social networking, for example. It also helps to ensure that the hundreds of thousands of pages of content created online each year (month?) are properly indexed and reviewed. They’ll also have to review fewer DTC TV ads, something they must loathe.

Everyone wins. It’ll mean that FDA will have to take some people off the “Professional House Organ” review team and move them over to the new “Social Networking” review team (there are no such teams, of course, but it’s fun to picture). FDA is also going to have to admit that it doesn’t know everything about digital promotion and that it needs help. It needs help crafting  the rules and getting their people educated. Who’s going to do that? The answer…Us.

You and me. I’ll start by crafting some guidelines on regulations for using digital technologies in promotion. It’ll be an open letter to the incoming FDA commissioner (whoever that is). You’ll help me make it sharp and add in what I’ve missed and we’ll take it to Washington. It’s just crazy enough that it might even work.

We’ve got to start somewhere. Be on the lookout in the coming weeks for my proposed regulations.

Jan 26th 2009 

Social Networking Doctors Overprescribe

Sure, the title of this is supposed to be a little provocative, but isn’t that the point? I’m taking a cue from the source of this information after all (read on, you’ll see). Recently, Pharmaceutical Executive published a report on a recent Manhattan Research study (press release here) looking at the use of online social networking sites by physicians. There’s already been some good debate about this article on several blogs, so I won’t rehash the same things, but rather I’d like to just correct some of the misconceptions of the study. 

First, the results. Here’s the relevant quote from the press release: “With about 60% of physicians already using or interested in using physician online communities, it’s the right time for pharma to look into the marketing and research opportunities offered by this channel,” said Erika S. Fishman, author of the analysis and Director of Research at Manhattan Research.”

So, 60% of physicians use or plan to use online social networks. Great. This shows that using this channel to communicate with physicians might now be a worthwhile opportunity. The study could have ended here and provided some valuable insight to the community. However, it didn’t. Instead, this piece of information has been pulled out from the study as well: physicians using online social networks prescribe an average of 24 more scrips each week than those not using these tools. Pharma Executive actually said this: “Although most of the data from the survey isn’t unexpected (users tend to be younger, female, primary care doctors, or smart phone owners), item of interest is that physicians that troll online forums prescribe an average of 24 more scrips each week than their unwired peers.”

The clear implication is that using online tools make physicians write more prescriptions. Perhaps I’m overinterpretting as I’ve seen on many other blog posts about this article, but I don’t think so. Here’s the next line in the Pharma Executive article: “According to Fishman [the study's author], this prescribing trend could be due to the almost “viral” nature of chat forums and bulletin boards. If one doctor talks about a positive reaction his or her patient had with a treatment option, other physicians could be more apt to prescribe it.”

So, there it is, the study’s author basically saying that these online social networks are making doctors write more prescriptions. No?

It’s great that more doctors are using social networking sites, but the stat about them writing 24 more scripts BECAUSE they use social networks is a bit much. There’s no control group here that accounts for physician age, practice size, specialty, etc. In other words, the likely  real answer is that doctors who use social networks have bigger practices and thus write more prescriptions. Social networking didn’t cause this, but rather is just another demographic point. It could be that older doctors, who practices are also smaller, don’t use social networking and this accounts for the difference. In fact, I’d guarantee this is the case.

I find it hard to believe that using a social network makes you write more prescriptions unless these users are suddenly now giving drugs to patients when they hadn’t before. I doubt this is the case.

A comment I made on this issue on a blog was answered by Manhattan Research and you’ll see that they defend their study, as they should. They say that the study doesn’t suggest that the social networking causes more prescriptions, but I’m just going by what the author herself said to Pharma Executive.

Unfortunately, all this debate has overshadowed a valuable piece of data. Social network use appears to have hit a critical mass among physicians. Indeed, these networks also seem to attract the physicians who write the most prescriptions as well. This is a potentially tremendous opportunity for the first healthcare company that can figure out how to crack into these networks. However, unwelcome intrusions won’t be greeted with open arms, so you must find the balance between promoting your products, but also keeping the spirit of the social network intact (i.e., no selling). People rejected Facebook’s Beacon concept even though it was friends selling to friends, but here, you aren’t even friends, so the backlash could be worse.

I think one of the best uses of these networks is (and will always be) for research and not for promotion. Sermo allows data to be gathered by pharma companies to see brand perceptions of its products and also provides some opportunities for clearly labeled sponsor questions. Listening to doctors talk to one another in the real world (not in contrived focus groups) when they aren’t being watched is where the most useful data comes from. Sermo allows this (after stripping out identifying information) and may provide the best, most accurate data about how physicians view and use certain drugs.

There’s still a great deal of work to be done here, but it’s a good start.

Jan 22nd 2009 

The Myth of Adverse Event Reporting

Mini White Paper

I’ve written a fair amount about the use of social media in healthcare (here and here), particularly pharma, on this blog. And, like many other people working to try to enhance healthcare marketing by including channels such as social media, I’ve heard all the same excuses. I was reading John Mack’s post today at Pharma Marketing Blog and it inspired me to write a quick little summary about what I call “The Myth of Adverse Event Reporting.”

Before getting to that, a little setup. Let’s be clear, the reality is that many healthcare companies (or many other industries for that matter) aren’t ready to incorporate social media into the mix. The specific reasons are different for each industry, but they share some commonalities. Here are the big reasons:

  1. Afraid to give up control of the brand
  2. It doesn’t work/impossible to measure
  3. No one in my target audience uses social media
  4. Worried about bad reviews

For pharma, these same reasons persist, but they have a little different spin:

  1. Same
  2. I can’t track it like physician-level prescription data
  3. Older people use my products and they don’t use social media
  4. Adverse Event reporting 

So, let’s take a look at each of these one at a time. I’ll save the one that kills me the most, Adverse Event Reporting, for last.

1. Afraid to give up control of the brand

Surprise, you already lost control of your brand. Conversations are going on without you already. Don’t believe me? Pull up any discussion board on WebMD. It’s going on without you. Search for your company’s products and see what people are saying. They’re saying it’s great, it’s horrible, it gives me gas, it makes my teeth whiter, it made Aunt Sally turn blue. They’re also giving and receiving medical advice that only a physician should give. So, if you think that allowing people to comment or post information about your product might take control from you, you’re right. However, do you want it happening on WebMD where you have no control and can’t really respond effectively or do you want it happening on your site where you can?

2. It doesn’t work/impossible to measure (for pharma: I can’t track it like physician-level prescription data)

First, social media is no harder to track or correlate with sales than any other online program done in healthcare (or offline for that matter). It is far more difficult in pharma to track the effects of a specific promotion on sales compared to other industries. In consumer packaged goods (CPG), for example, you can do panel match studies where you know who is doing what, what messages they are exposed to, and if it had a specific lift in sales. Our company does this all the time. In pharma, you don’t have this level data and you never will. HIPPA prevents it. So, get used to that. You can’t determine if someone who saw your commercial actually went and got a prescription and filled it. You can ask them, but that’s not reliable. The fact is, you may need to use other measures to determine if the program is effective. You do many programs where the efficacy is measured in clicks or visitors (rightly or wrongly) and you can do the same in social media. In addition,  in social media, you can actually track real-time brand sentiment. Instead of being a tactic to completely change opinions, you can actually use it as the proverbial “canary in a coal mine” to see if your other activities and messages are having an impact on opinion. For example, if you put out a new TV ad (please don’t by the way), you can rest assured that someone is commenting on it right now online. What does that conversation look like?

3. No one in my target audience uses social media (for pharma: Older people use my products and they don’t use social media) 

This simply isn’t the case anymore. You should know this by now. No? Well, here’s the info one more time. Consider just one social networking site for a minute. Facebook. Its share of college age users continues to decline every month. In addition, in the US, there are over 4 million users over the age of 35.

Isn’t 4 million a lot? Sure, it’s not number of people watching American Idol each week, but it’s not a small number. That’s just Facebook. Rest assured that the number of “older” people using social media will only increase in the future.

4. Worried about bad reviews (for pharma: Adverse Event reporting)

So, this is the main reason for today’s post, but since you came all this way, I figured I’d give you a few other things first. No charge. Let’s address bad reviews first. Product reviews are the norm now in ecommerce, but they weren’t always. One of the big reasons is that companies were afraid of negative reviews. It turns out, of course, that simply having reviews can increase traffic, conversion rate, and average order value (see more detail here). In addition, negative reviews aren’t an issue so long as there aren’t only negative reviews.  Consider yourself for a minute. You’re checking out a product online and all the reviews are glowing. What do you think about that? You’d probably feel like the results might not be all that authentic. Instead, when there are negative reviews, it actually can lend credibility to the product (and site) because people know the reviews are actually genuine. Negative reviews don’t turn people off. They read them and consider whether the negative would actually bother them. For example, someone ranks a product 1-star and says “this didn’t work on my Mac.” Well, if you have a PC, you aren’t worried. Simple example, but you see how it works.

Adverse Events are nothing more than negative reviews. If you want people to genuinely talk about your brand, they are going to say negative things. But how often do posts include adverse events? Nielsen decided to take a look at this rather than simply assume it was ” a lot,” which of course is a difficult number to manage. Nielsen looked at Yahoo Health boards and took 500 postings. Of these, only 1 contained enough information to qualify as an adverse event that needed to be reported. That’s 0.2%. Why so low? Turns out that someone simply saying that your drug caused them to have a headache isn’t enough to qualify as an adverse event. Nielsen summed up the pieces of information required to report an adverse event and there are four pieces: “(i) an identifiable patient; (ii) an identifiable reporter; (iii) a specific drug or biologic involved in the event; and (iv) an adverse event or fatal outcome.” (Hat tip to Pharma 2.0 for the summary). The study showed that one or two of these pieces were often available, but not all four. In addition, they found that it would be impossible to get all four even with some effort. In fact, the FDA says, “[Without these pieces] a report on the incident should not be submitted to the FDA because reports without such information make interpretation of their significance difficult, at best, and impossible, in most instances.”

This is because people often don’t register or leave their personal information in a post, so there is no way for a company to follow up and fill in the blanks. Naturally, if there is something significant, every effort should be made, but on the often anonymous Internet, this is usually difficult. Suppose for a moment there were several adverse events that need to be reported. How often do they need to be reported? The FDA is pretty clear on this. For new drugs, reports need to be filed quarterly for three years. After that, it’s annually. For “serious and unexpected” events, these have to be reported within 15 days. However, there’s a pretty high threshold for an adverse event to be considered “serious and unexpected.” Every company already has these reporting channels in place, so it is simply a matter of including adverse events received from social media into the workstream. 

 

Yes, it’s a balance. The fact is adverse events should not be the reason why healthcare shies away from social media. These risks can easily be mitigated and, if done right, can actually be used in a positive way. So, don’t use adverse events as an excuse anymore. You’ve got the data. 1 in 500 posts include a reportable event. You report quarterly at most (which you’re doing anyway). How much ongoing effort do your other marketing programs require? Probably quite a bit more than this. Next time you hear this excuse, you’ve got the data to dispel the myth of adverse event reporting.

Jan 16th 2009 

US Pharma Can’t Win (Awards that Is)

Pharma in the US has had a rough go over the past several years getting crushed by bad PR, new legislation, and a few monster fines. Of course, a lot of it the industry brought upon itself, but some is owed to the fact that nothing is more regulated than prescription drugs in the United States (perhaps plutonium is slightly more regulated, but not much). This regulation is partly where pharma places blame for slumping sales. They argue that their hands are tied and that’s it’s extremely difficult to get the word out about the benefits of new and existing products (or to simply get them approved). Of course, it is easier in the US than pretty much anywhere (except New Zealand), as the US does have the benefit of being allowed to do DTC advertising. Imagine what it would be like without that. Not that bad, right? Maybe, maybe not.

I’m not going to argue whether these regulations  are good or bad. That’s a whole other issue. Today, I’m just going to make a few observations. 

The big awards show for pharma marketing is The RX Club. The winners of the latest round of awards were announced back in November, but I was reviewing some of the winners’ work again yesterday and something stood out to me. The RX Club is an international competition. Anyone can enter. It’s not just pharma, but also medical devices as well (OTC products is a different competition). What struck me as so odd this year was the list of Gold and Silver winners (the highest level awards). There were 29 Gold or Silver winners this year who get a slick trophy like this:

RX Club Award

Here’s how the winners break out:

 

  • 14 of 29 Gold or Silver winners were for campaigns outside the US.
  • 3 of the 29 were agency self-promotion
  • 1 was for the RX Club Awards itself (hmmm…)
  • 12 of 29 were for US based product campaigns
  • 0 (yes, zero) of 29 were for digital programs (websites, email, e-detailing, etc.)

 

Two observations. Of all the winners, only 40% were for US based product campaigns. The wide majority went to campaigns outside the US. So, is this because the international agencies are so much better than their US counterparts? Or, is it because they are free to do a lot more than what is permitted here in the US? As an employee of one of these US agencies, Bridge Worldwide, I don’t think it’s the former. As a former pharma marketer, I know it’s the latter. I’ve watched great concepts get watered down, picked apart, genericized to the point that they are unrecognizable and hugely boring all to meet either FDA (DDMAC) or internal regulations. The fact is that, in the US, you can’t get away with some of the winning campaigns that were done outside the US.

I’m not taking anything from the winners. They are excellent. Perhaps I’m jealous. I wish that we were permitted to do this type of work here. Are the regulations that make this exceptionally difficult really protecting anyone? I’ll leave that one for you to debate.

The bigger concern to me is that none of the Gold or Silver winners went to digital campaigns. A number of Award of Excellence prizes did (including 2 to our company for digital campaigns), but not the big prizes. Instead, the big prizes went to TV, print, mailers and the like. But there were no digital winners (InVivo Communications did win a Gold for a great animation, but not a campaign).

So, why is this? Last year (2007), 3 of 38 Gold or Silver winners were digital work…that’s a two-year total of 4.4% for digital. So, it’s not just an off year in 2008. It’s ongoing. Is the digital work not up to snuff or are the judges not as comfortable with digital which makes it harder to evaluate opposite a simple one page advertisment? How do you compare them? It’s easy to compare a good versus bad print add, but how do you compare a good digital program versus a good print ad? My thought is that they don’t know how to compare the two and maybe no one does. 

That’s the point of this blog. Digital is still seen as another tactic that you bolt on at the end and never the lead tactic or overarching strategic idea to lead a marketing effort in pharma. In other industries, this isn’t the case and our agency works on quite a few like this, but pharma still isn’t there. Why? I think I spelled out a number of reasons in my recent Healthcare Marketing New Year’s Resolutions series especially “Pick a Fight with Your Regulatory Team.” There’s a lack of education among healthcare marketers about what good looks like in digital and how to press their agencies to deliver it. In addition, for all the great digital agenies out there, there are an equal number of not-so-great ones skating by because few people can call them out.

Do I have evidence? I guess I do now. The biggest pharma awards show and not a single digital program winner. Looks like I’ve got a lot more work to do.

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