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Category: Health on the Web

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.

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?”

Teva Canadian MS Community: No Win for the Company

Teva is closing its community forum from its Canadian multiple sclerosis education website because of Canadian healthcare regulations around dissemination of information relating to prescription drugs.

You’ll read the explanation if you visit the Teva MS website, but keep reading for the crux of the situation:

I have to agree with Teva’s decision because it becomes a no-win for Teva. If Teva were to hire someone to conform to regulations and actively monitor the site, the patients could claim that Teva would allow only favorable comments when it may in …fact be a perception issue. Teva could be allowing only approved/indicated usage discussions posted, rather than removing unfavorable comments to Teva.

On the other hand, Teva stands to be liable for any damages claimed by patients who said they tried something because of what they had in a Teva-hosted discussion forum even if it was not sanctioned by Teva and even if Teva could have disclaimers abound. If I were a company I would not allow a truly “free” discussion forum, other than one that deals specifically with the approved indication of its drug, and even then would question the utility of this over an actual conversation with a licensed healthcare provider.

I see this as a case of controlling information not for restricting its availability but for the sake of responsibility of how that information is used. Drug information can be used out of context and inadvertently harm patients.

On the other hand, non-profit patient advocacy sites will host these discussion forums, and they appear to legally be able to do so. It would be interesting to see how these associations deal with legal situations that could potentially arise from patients being injured or harmed by information shared on the site that may not be accurate or even safe for others. This is a delicate balance of sharing information to help while keeping that Hippocratic “do not harm” oath in mind. Even if the intention is good, injury can occur because of misuse (and that misuse does not have to be intentional, either, it could be accidental).

But the reality is, drug companies are more likely to get sued than non-profits!

First heard from: Nat Bourre

Kids Not Getting Enough Cholesterol?

I had no idea that September National Cholesterol Education Month, but it is, and I saw a press release about nonprofit nutrition education organization Weston A. Price Foundation on getting consumers to recognize the importance of cholesterol.

The press release made sense to me, but it seriously will meet lots of antagonism because of the prevalent trend of obese children in the USA these days. I bet these kids have ridiculously high cholesterol levels – and certainly not from eating too much “nutrient dense” foods. So while I as a scientist and also as mother of a toddler who needs lots of “good fats” can sympathize, I don’t think the argument here can stand up to even one voice saying “… then what about all this concern with childhood obesity?”

I sent my query off to the publicist, who got in touch with the Sally Fallon Morell, president of the Weston A. Price Foundation to respond to my challenge above. Sally’s response is here.

I followed the links given as references, including the one from the Foundation itself:
Dietary Recommendations for Children –A Recipe for Future Heart Disease?

“Just Say No!”
When it comes to feeding their children, parents should “just say no!” to the government’s dietary guidelines. Children need a diet rich in traditional fats in order to achieve optimum growth and development, as well as protection from heart disease later in life.

I wished it had addressed additionally the issue of fast foods – because this is the reality of “kids’ diets” these days… if saturated fat plays a role in children’s growth, at what point do parents draw the line in where that source of saturated fat comes from? (this question was answered by another link that Sally’s response included, but I wished the above information would address it immediately rather than me having to look at another (non-related to the foundation) link.

I also found the Swedish study findings interesting, mostly because I’ve been drinking more whole milk (full fat) since that’s what I give to my child, who is almost 2 at this writing. Our pediatrician had told us that at this point, we should cut back milk for him because it doesn’t really do much for him other than the calcium and vitamin D that he can be easily getting from other sources.

I don’t know how much this would convince you as a consumer about the benefits of cholesterol in children. On an objectivity scale, I would have preferred that the links I received were original source citations (i.e. links to the original scientific studies published – such as from PubMed) rather than what appears to be commercial pages or user-contributed pages.

How Useful is Social Media in Pharmacovigilance?

By Jane Chin, Ph.D.

In theory, engaging social media in pharmacovigilance is attractive, if not sensible.

In practice, engaging social media in pharmacovigilance will be fraught with such high noise-to-signal ratio that both pharma companies and regulatory agencies may struggle to embrace it.

image by ilker Let’s look at how pharmacovigilance has fared from the field perspective. We (used to) have over 100,000 sales reps in the field, who are exposed to adverse events signals every single day, I’d even surmise at least once a day.

All company employees in the U.S. pharmaceutical industry are legally obligated to report an adverse event within 24 hours of receipt from the field or through other communication channels.

Yet today adverse events reporting – sans Web 2.0 – has been bogged down with bureaucracy, and physicians who are willing to spend the time and effort to report AEs directly to the FDA are enormously frustrated with the red tape and hurdles they face. It soon became a lose-lose proposition for doctors whose continuing livelihood has come to depend on patients/day type of clinical practice management.

Will Web 2.0 perhaps simplify the process and reduce red tape? I believe the potential is there.

The question is – HOW? At least, from the regulatory / federal government side.

From the commercial side, the question for pharmaceutical companies becomes – WHY ON EARTH…?

There are so many layers of medical history and patient health context that must be addressed when an adverse event arises – were there confounding factors? was the patient compliant? – that stripping the context away makes the content dangerously misleading when interpreting the safety of a drug.

Google Healthcare Ads and False Claims

Jeanne Sather has written a longer response to my post on Google Coop for Health. Instead of leaving it as a “comment” I’ve decided to post it here as an article, because she has raised an important issue about Google Ads, which this site uses. By the way I’d love to use blogads, if I can get an invite from someone, because I’ve written them several times and haven’t heard a peep from the admins.

Google has a lot to answer for in the ads that it runs on the Web. The company has been very irresponsible in carrying ads for products that are nothing more than snake oil. (more…)

Misleading Healthcare Ads and False Claims

Google has made astronomical profit from its advertisement programs, at least $900 million. Certainly, Google’s Adsense/Adwords services has benefitted both website publishers and businesses alike. Nakedmedicine.com takes advantage of Google’s Adsense service to display contextual (relevant) ads that Google serves up from advertisers, and when visitors click through to products and services that they are interested in, this website benefits by gaining a few cents in the “Website Operations and Maintenance” kitty. Google also serves up text-based, contextual ads next to key word search results.

When you mix free speech, lax advertising content policy enforcement, and opportunistic merchants, you come face to face with asking where the buck stops when consumers are barraged with misleading healthcare ads and false claims for miracle cures. (more…)

New Google Co-Op for Health

Google has created clusters of online discussion format called Co-ops.

The Co-op is about “sharing expertise” (source: Google Co-Op website), I assume from whoever feel they have expertise to share. A Google employee posted general criteria about what posts would be stricken from a Co-op group:

  • The posting of commercial advertisements or other promotional material
  • Spamming/excessive multi-posting
  • Chain letters
  • Binary (non-text) postings
  • Forgery of another user’s identity

(Source: Thread ID c603a0b6578b735a)

Currently,”significant contributors” to Google Co-Op’s Health topic National Library of Medicine, Centers for Disease Control and Prevention, Health On The Net Foundation, Harvard Medical School, Mayo Clinic, University of California San Francisco, and Kaiser Permanente. (more…)

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