Category Archives: Social Media in Medicine

Dream and Nightmare of Web-Scale Pharmacovigilance

I’m not going to tap into fear-mongering of why Microsoft is involved in the study that pulls adverse event (side effect) data from the internet, but I’m wondering what’s taken people so long to figure out the vast pool of patient experiences available online. Oh wait, those of us involved in industry know about this, only we don’t want to know about it.

There is at least one valid reason: you need to have a full picture of what is involved behind a side effect, to say with some level of confidence that your reported side effect experience came from the drug you said you took, not the other drugs you’re conveniently not saying you’re taking (especially the not-so-legal kind), or that you have a drinking habit (alcohol has major interactions with every drug under the sun), or that you’re taking 20 supplements you got from the nutritional store, and some prescription med you got off the internet by some shady doctor who asked you a few questions before writing you the Rx…

But reality check. Web-scale pharmacovigilance is here, and needs to be here, and should be leveraged conscientiously and systematically.

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Some years ago I gave a talk at a DTC conference in New Jersey about the patients’ voice when it comes to safety information. I am not in the business of web-based pharmacovigilance, nor did I set out to collect this information, but patients started sharing their personal experiences with an antidepressant on my mental health website. Yes, there are paroxetine/Paxil-related reports, but for the most part patients talk about bupropion/Wellbutrin, and over the span of many years there are hundreds of patient reports that are consistent in terms of their side effect experience.

This all started with one reader asking a question about a particular side effect of bupropion, and whether there were any published studies about a particular side effect. I’m sure there are scores of data from the manufacturer, but like much of drug data, these are kept “proprietary” with the ever-present “data on file” label on clinical slide presentations that the manufacturer supplies to a well-selected public (doctors).

Industry shouldn’t fear it or revile it: pharmacovigilance is critical for gathering drug information over time as part of safety monitoring, and the FDA sucks at making this an easy task for anyone with the desire to report adverse events with bureaucracy.

Read NYT’s take on web-scale adverse event reporting and drug safety monitoring.

Patient Hot Buttons in Pharma — Series with Casey Quinlan

Introduction: I met Casey Quinlan in October 2011 when we both presented at a Digital Pharma industry conference hosted by DTC Perspectives. Casey describes herself as a “rabble rouser”, and of course, I cannot resist. This is a series of conversations with Casey on various “Patient Hot Buttons in Pharma” that we will be relay-blogging.

Casey

Jane

Segments of this Series:

Absurd Advertising

Lack of Transparency

Behind the scenes manipulation we sense but can’t see

Lack of Presence

Cost

Pharma Companies that Can’t Handle Comments Should Get Off Facebook, Good Riddance!

Jonathan at Dose of Digital talks about pharma’s fear of Facebook pages centering around 2 issues that pharma thinks require 24/7 monitoring: Adverse Events and negative publicity.

I hear the same excuse on why pharma companies are so scared to look at patient comments on blogs: adverse events.

I’m sorry, but adverse events are happening whether pharma companies are monitoring or not, and this is different from monitoring whether someone’s posting something “bad” about your company (newsflash: not everyone’s going to like you, better to expect it and have rules to address it than bury your head in the sand).


Adverse events are crucial for patient adherence and avoiding Facebook comments for fear of posts on AE is a missed opportunity for pharma to engage with patients in an issue that they all care about.

Patients expect drugs to work — rarely will patients want to get on a pharma page to thank the company for making a product that works. You may have a cancer patient who will do this if the company has gone above and beyond the call of duty to help the patient gain access to the drug that the patient otherwise cannot afford. But for the most part, patients have a “love-hate” relationship with pharma companies that is more “hate” than “love”, and I can’t blame patients for feeling this way.

What patients gripe about, and fear, and dread, are the adverse events.

Adverse events chip away a patient’s hope of getting better.

Adverse events erode a patient’s quality of life.

Adverse events make patients wonder, “would I rather stay ill, or deal with this horrible side effect?”

Then they look at companies avoiding discussion about something that is so key to their treatment experience, they naturally assume “profits before patients”. Never mind the realities of bureaucracy in adverse event reporting, I know it’s a bitch… the FDA knows it too.

That’s how pharma companies come across in their being so scared about Facebook.

Funny… I rarely recall pharma companies coming across scared when some of their sales and marketing teams find creative ways to fly under the radar to promote off-label. Somehow these companies are fine with breaking the law to “expand” usage of their drugs, but now they’re claiming they can’t deal with lack of guidance where Facebook pages are concerned.

Better companies pull their pages off Facebook if they are hard-headed about not allowing comments. Leave those who are more enlightened to get those patients’ eyeballs and possibly gain some goodwill.

Companies who want to control the message and behave hypocritically are doing the right thing by leaving Facebook: they aren’t adding value on the social network anyway.

Pharma and Social Media: It’s Not About Controlling the Conversation, but Finding the Right Venues for Engagement

Now that Facebook Pages is to Marketing what LinkedIn Profiles is to Job Seeking – pharma companies are in pickle: Facebook is going to open up comments no matter what.

This means pharma companies can no longer restrict people from commenting on their Facebook pages.

Er…. DUH! Why is this big news? People get on Facebook to socialize – and not just to socialize – but to socialize in a mildly (or very) uninhibited manner. Facebook is MySpace done artfully and profitably, where we aren’t subjected to blinking starry page backgrounds or annoying music on auto-loop.

But remember why Facebook was created, and why Facebook has taken off with businesses – it is because when people are less inhibited, they are more suggestive, and more likely to click on links that businesses want them to click to buy stuff!

If businesses want stuffy and formal – there’s already a Facebook for that – it’s called LinkedIn.

I realize that it makes good sense for pharma to get its brands and company names out there. The problem is that when the public engages pharma, if they don’t ask about products, what would they want to engage pharma about?

[Assuming they aren’t interested in engaging pharma companies to ask, “why are you charging such high prices for drugs I need to save my life?”]

It’s akin to expecting a customer who drives a Toyota Corolla here in the U.S. not to engage the company Toyota to ask about the Corolla he drives. Unless that customer happens to work in an area that involves some business process, thereby predisposing the customer to want to ask about how Toyota “the company” works, customers often equate the company with the brands they use.

I understand that pharma industry supporters, including myself, would love if pharma can once again establish credibility with consumers by focusing on their support of disease state research and advancement.

Only another party’s already settled in that domain: they’re called physicians.

Physicians are typically seen as providers of support to patients in disease areas, from the consumer perspective. Let’s say I experience the symptoms of clinical depression – I’d naturally think, “I need to seek info from the doctors (once I learn more about this on the web)”.

I am not thinking, “I wonder what information GSK or Pfizer is providing in treating depression.” I’m not even thinking, “I wonder how Forest Laboratories or AstraZeneca are supporting R&D in depression relapse.”

But I may think in drug names, like, “I wonder if I should ask my doctor about Abilify, or Zoloft.”

[note: this would be an off-label use of Abilify, since Abilify is not approved for first-line use in treating depression, only as an adjunct to a first-line treatment if that treatment isn’t working as well as it should; it’s like a “boost”. But I use Abilify because I’ve been seeing so many ads on TV for it, and I honestly haven’t seen that Zoloft bouncy little ball in ages on TV.]

Thus there is first a cognitive hurdle that will not be easily passed. It is that diploma on the wall that garners the physician ‘credibility’, just as it is the commercial/business status that garners the pharma industry ‘lack of credibility’ when it comes to its participation as providers of information on the disease state, no matter how objective pharma tries to be.

In fact, even a recent survey of U.S. physicians had shown that they don’t want to pay for their own CMEs, yet they also won’t trust the CME content that is supported by pharma thereby making CME affordable (“free”) for them!

Logistically, the speed of Facebook and Twitter is exactly why Pharma should must hesitate.

People don’t go on FB/TW expecting a support-ticket time-frame (“slow”) response. They are on these platforms for just in time/immediate responses (“fast” “NOW!”). Otherwise, why bother? There are already online forums or patient info phone numbers for support-ticket speed “communication”.

It is not just about the platform, but the patient expectation that comes with the platform.

If you had ever engaged in a hashtag-driven Twitter chat, then you’d know how it’s next to impossible to follow every single conversation that comes at you in firehose fashion. Imagine then if there’s one or two patient complaints or problems amid the 20 other divergent discussions.

That’s what trying to retain “form” around a topical discussion may look like when Facebook comments are opened up for pharma.

[Lest any of us had forgotten – remember the “Motrin Mom” event, where a twitter indignation went viral and before the end of the weekend, the U.S. VP of Marketing at McNeil had to take that YouTube ad down? Try controlling THAT hashtag outbreak; I was there and saw how quickly it amplified.]

I’m 100% for increasing dialog between industry and consumers/public. Yet I think we can’t equate social media platforms the same, just as we can’t equate popular venues the same for medical education.

There are some social media platforms that are akin to a quiet, business like conference room.

Then there are social media platforms where people go for happy hour and unwind and engage in more personal conversations than business.

Then there are social media platforms where people go in expecting a brawl and in fact that’s why they showed up in the first place.

Pharma needs to identify these types of platforms and, rather than forcing or imposing artificial constraints by making everyone show up to a bar in a business suit.

The question Pharma needs to ask is, “is the purpose we intend to serve by showing up here feasibly achievable by the expectations of the crowd who will also show up?”

FDA Has to Slow Down to Keep Up with Drug Companies

Steve Woodruff is hopping mad with the apparent gross inefficiency and indecision of the “guidance process” for pharma company promotional practices when it comes to social media, and I can’t blame him!

But I’m on the FDA’s side this time.

Let me say up front that I never liked how the FDA remains vague and slow in the past, it sucked when I was a pharma employee trying to figure out just what the FDA “wants”, but the FDA had long acted like a tripped out lover who has something in mind but we’re supposed to guess or better yet – read his mind.

But today I am much more forgiving of the FDA than I am of pharma company management.

I was looking at a recent run down of 2010′s lawsuits settled by drug companies and to say that I’m disappointed with industry’s continual hypocrisy is a gross understatement.

It’s one thing when you can say that you’re working toward implementation of compliance practices. It’s another when you take one step forward and 3 steps back as an industry in something as “common sense” as “don’t mislead the public” (in every which way that can be done via old media/new media).

For so many years whether as employee or consultant, I have heard company management say “Patients are our #1 concern! People are our greatest asset! We want to do the right thing!” in public forums and company meetings. Then I look at the actions that are motivated by incentives and hidden rules at companies.

I’m not surprised why the government keeps ramping up its prosecution arm. I get that pharma changes are slow, but this looks almost as if pharma wants to test how slow it can change.

I’m not surprised the FDA has to “slow down to keep up”.

I have read some of the recent untitled warning letters sent to pharmacos, and the violative actions from pharmacos. HAVE YOU READ THESE? Look at the list growing from year to year. And how the SAME CITATIONS KEEP COMING UP, AGAIN AND AGAIN.

If I had to cull through the sheer amount of garbage that pharmacos continue to churn out as sales aid, my resources would come up short as well.

It’s like, pharma companies can’t learn!

It makes me want to say, “come on pharmaco people, you guys come armed with MBAs and doctorate degrees, you have teams of lawyers…. SERIOUSLY? THIS TYPE OF VIOLATION – STILL?”

Or more accurately, maybe they just don’t want to learn.

Maybe it’s still a game to see how much money you can make when you push the envelope and offset the profits with FDA imposed penalties and fines.

Even when you slapped with a huge lawsuit costing you hundreds of millions of dollars, well you can act like this is the stock market and say if you earned more revenue than lose it as a liability of “market fluctuation or market conditions” you’ll still come out on top.

Meanwhile, patients lose, healthcare loses, and pharma employees who actually want to do the right thing when earning their keep lose.