One of my friends (Lynn Brown) wrote about defending your reputation in the age of social media, last week. [Sorry- Lynn removed the actual blog from circulation sometime during the past decade (30June2021)] The same time that big pharma was pulling back from their Facebook efforts.
Why? Because Facebook provided them with a special policy that exempted the drug companies from the need to maintain open ‘walls’. This meant that it was impossible to report side effects or promote off-label uses on their pages- without the prior approval of the company. Kind of like the policy I maintain on my blog (but no one else can do on Facebook)- I approve each comment. (NOTE: My rejection criteria is simple: If all you do is promote a product or service- with no commentary on the subject of the post, I remove the link. Otherwise, everything goes. It’s your reputation on the line, not mine!)
Big Pharma had not rushed into the Facebook phenomenon; they waited until Facebook offered this policy to them, about 18 months ago. The FDA has yet to release any guidelines that cover these online engagements with consumers.
The lack of a policy creates a problem for big pharma. The draft regulations that were expected in 2010 never arrived- nor have they yet. Having worked with companies that were cited for breaking unwritten FDA regs, I know the delay in issuing guidance or regulations is a big problem for any medical entity.
The drug companies know that promoting off-label use is a sure way to gain FDA attention- fast. And, the posting of side effects can trigger another FDA reporting issue. Reporting an unexpected reaction/injury on their walls could qualify as an Adverse Event Report (AER), which involves special forms that must be reported to the FDA.
Hence, the big emmigration…
Amgen decided last week to remove its page, “Breakaway from Cancer”. This was part of their promotion for Vectibix, Neupogen, and Neulasta. But, then, it reversed the decision. My guess is they are readying 24X7 monitoring of their page to remove any problematic posts.
Bayer killed its page, “Strong at Heart”. But, that’s not a full withdrawal, since “I am ProHeart” is still among the Facebook pages- at least, as of this writing (way before it’s posted). But that page is for its aspirin product, which has been around forever- so much so, that we (no, not the FDA) consider it GRAS (generally recognized as safe).
A less prominent page to be killed was “In the Face of Pain”, which was maintained by Purdue Pharma. The products that were promoted there were Dilaudid, Ryzolt, and Butrans, among others.
I have heard that J&J (Johnson and Johnson) killed several pages (Allies and Moms for ADHD, among others), as did AstraZeneca (“Take on Depression”), once the Facebook policy change was announced.
By the way, this was a potential issue for the financial services industry, too. But their oversight authority (FINRA, the Financial Industry Regulatory Authority) released guidelines last year that deals with insider information, stock promotion, and the like..
P.S. Joshua Zamora asked an important question about something that I did not properly address in the post. He asked why would drug companies NOT want adverse effects to be reported. The answer is they do- but they need to get certain information to determine IF it is a true adverse affect and WHY it was. Here is more of my answer to Joshua:
…I can give you the best reason with two specific examples of which I am personally aware.
1. A clinical trial has begun to determine if a new development really does provide the results one hopes. Yes, it makes therapy simpler, but is the therapy better or safer? During the trial, a clinician calls our office to inform us a patient is dead, around 3 PM. Stop, halt, do not pass go. I fly out to the site, arriving late that night. All night long, I can’t sleep worrying about what could possibly be the cause. Early the next morning, I find out that the patient was killed crossing the street. Obviously, not an issue with the therapy.
2. There are a few people out there who routinely report that their children developed autism or even worse that their child died as a result of an inoculation. To date, there is no scientific basis for this (in my mind, ridiculous) claim.
Side effects are taken seriously by 99% of all drug companies. I would love to say 100%, but we know there are some bad actors out there. They want to investigate and evaluate each potential side effect. But, they don’t want to deal with crackpots, who waste valuable resources and time- time and resources needed to develop better drugs.
On an open forum, it “should” be understood that any individual’s proclamation may be fictitious, exaggerated, or misinformed. When the “religious” nut said the world was going to end a few months ago, was he sued for liable? No! And why not? Well, I am not sure of the technical legal reasons, but I suspect that the common sense notion that there are lots of talking nuts who should not be taken seriously is a viable consideration.
If someone at my favorite coffee house tells me Bayer Aspirin gave him stomach cancer, can Bayer sue him? Probably not. But if Ophra Winfry says cow meat has too many hormones, including steroids, and that this could lead to cancer, can she be sued? Apparently, yes. So my guess is, if you own a printing press, (or the modern equivalent thereof) then you can be sued. But wait, what about all those alien abduction web sites, can I sue them for misinforming me? Probably not.
I just do not see how a pharmaceutical company can be held liable for something Joe cyber-citizen posts on Facebook. Or was the issue what the pharmaceutical company wants to reveal? Well then, the Notes section can be relabeled “Known Potential Side Effects and practiced off lable uses.” And the posting section can be labeled “Mostly Fiction”.
Interesting thoughts, there, George.
Who knows who’s listening at the coffee house- maybe enough that it could be an issue in a lawsuit.
And, unfortunately, the drug companies would certainly be liable for off-label uses that were listed on their website.
Roy
Interesting…but help a poor non American out, ‘off label’ use? What is this and why would it attract FDA attention ?
Sorry for not making that clear, Pea.
Let’s assume I developed this new drug for bowel surgery. It works perfectly in that it cleans out your colon so that there is no chance for infection during the subsequent surgery. Now, some entrepreneur (Joe Makeabuck) who knows many people believe that colon cleanses improve their health and body functions (no proof this is even close). And, starts promoting my drug for his goals.
I have do no testing to prove that this is safe and effective for this application. I have no approval from the FDA for this purpose. And, I have no data that taking my drug- which was designed for once a year AT BEST usage can be taken multiple times in a year or a month.
Now, Makeabuck promotes the use of my drug on HIS website. I am probably liable for the off-drug usage. But, imagine if he posts this on MY website (by an overlay or via the FB wall posting). I am definitely liable.
Hopefully, that clears the confusion.
Roy
Interesting post, Roy. Seems so odd that a company can be cited for an unwritten regulations. A tricky situation for these companies for sure. It’s mind boggling how much power social media can have. Good and bad. Great info! ~ Suerae
Suerae Stein recently posted..Fab Foto Friday – Chicago!
Suerae, this is one of the few agreements I have with certain political elements (and probably the only one) about government regulations. The difference is there is NO regulation written, but considerations have to be made to guess what the intent will be. It is easy when there is a regulation (and don’t these same folks claim that they want clear guidance and hate uncertainty???).
Roy
Figures there’d be a special policy for them… and interesting to see what happens when it changes. I can see where it’d be a sticky situation with all the FDA reporting and other requirements, but they’re not exactly known for their sunshine and open door policies in the first place.
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Absolutely, Michelle.
And, it would be even more interesting if the FDA would publish their regulations to make it easier in the first place. (Maybe they are afraid of the backlash in issuing another regulation.)
Roy
Hey Roy! Great post! But im a bit confused. Isn’t it a good thing for these companies to notify users about the side effects of a drug?
If they can get their message out quicker and less expensive through social media it should be a win win no?
Joshua the ZamuraiBlogger
Joshua.
Thanks for your question. And, I can give you the best reason with two specific examples of which I am personally aware.
1. A clinical trial has begun to determine if a new development really does provide the results one hopes. Yes, it makes therapy simpler, but is the therapy better or safer? During the trial, a clinician calls our office to inform us a patient is dead, around 3 PM. Stop, halt, do not pass go. I fly out to the site, arriving late that night. All night long, I can’t sleep worrying about what could possibly be the cause. Early the next morning, I find out that the patient was killed crossing the street. Obviously, not an issue with the therapy.
2. There are a few people out there who routinely report that their children developed autism or even worse that their child died as a result of an inoculation. To date, there is no scientific basis for this (in my mind, ridiculous) claim.
Side effects are taken seriously by 99% of all drug companies. I would love to say 100%, but we know there are some bad actors out there. They want to investigate and evaluate each potential side effect. But, they don’t want to deal with crackpots, who waste valuable resources and time- time and resources needed to develop better drugs.
Hey Roy,
I was so unaware of this immigration thing happening on Facebook! Thanks for bringing that to my notice. I think it depends on what works for the company and for facebook themselves. But yes, like you earlier trust works both ways and it is quite applicable here too!
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Trust is the key, Hajra.
Check out my answer to Joshua- which will be added to my blog posting, since I believe he brought up a fact that I did not well explain in my post.
Roy
I can see where certain kinds of posts could be a problem for the pharmacy companies. I truly get very tired of watching advertisements for drugs on TV. These companies spend millions of dollars pushing their drugs on people who probably don’t really need them. I don’t think they want to connect with their customers, they just want to make $$$.
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Janette:
They certainly do want to make money.
I, too, do not understand the incessant blitzing of the airwaves with these drug commercials. I would love the regulators to say these are illegal. It’s the physician who prescribes them- but the drug comapnies found that they can scare folks into demanding their doctors give them these drugs that may or may not be better than what they are already prescribed.
Roy
Roy, these are all events that make consumers suspicious of these pharma companies – like what are they hiding/ afraid of? Calls for serious concern and especially our need to be more cautious of the drugs we consume from these manufacturers.
Stella:
See my answer to Joshua.
It’s the potential crackpot complainer that wastes their time and resources. (They already have systems in place to track adverse effects- both for endusers and professionals.)
Roy
Hi Roy,
I love that. Big pharma. The drug industry constantly tries to insulate itself from public scrutiny. I’m glad to know that they won’t be using social media. Why should they be protected more than the rest of us who market our businesses? Especially since their products have the potential to harm us.
Thanks for the update!
Sherrie
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Sherrie:
I am not sure they are trying to insulate themselves from public scrutiny. Of course, there are some actions- like the recent ones by J&J, which destroyed their once stellar reputation, when they tried to cover up their product recall by buying back every affected drug from the marketplace.
They just don’t want to waste resources tracking down crackpots.
Roy
Reputation certainly is important. I wonder Roy if these companies leaving Facebook may consider looking into Google+ or what other platforms would they consider? Also seems like so many organizations and regulations, it just makes my head spin!
Lynn Brown recently posted..Top 3 Facebook Marketing Mistakes – Avoid Them At Your Own Risk
I think most of their companies are generally conservative (not politically) in their actions. Just like they were among the last to jump on the FB bandwagon, they will join Google+ when it reaches a certain critical mass. I know many are watching Twitter feeds for any mentions of their drugs and firms.
This will be very interesting, Lynn.
Thanks for the comments.
Roy
Hmmm….interesting…and perhaps potential for a slippery slope. I feel we should have the right to govern what goes on our pages AND at the same time we need to be transparent about who we are….so if a drug company is sponsoring a page and making it look like an unrelated organization, non-profit group, etc. I feel consumers have a right to know that what is being posted may have been influenced by an outside source. Really underlines the point of being authentic, Roy A. Ackerman and Lynn Brown.
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Tambre:
I have real problems with the use of a “bogus” third party for posting, producing a wall, etc. Whether it’s a drug, a food, or a political candidate!
Roy
Hi Roy,
I am not very familiar with legal issues here. But one of the biggest disadvantage of social media is that there is too much freedom for everyone to say anything they want. Any drug issues reported can really be critical. I will not only grab the FDA’s attention but the people’s too. You know how a small issue can turn big in the cyberworld. I am looking at this new policy as a change for the betterment of everyone.
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Hi, Alex:
Nice to meet you and glad you left a comment.
You are right about those issues. About a decade ago, a bunch of people found a way to overlay various websites with their comments. That disappeared with the next generation of HTML encoding, and I don’t think it has reappeared. But, Facebook is altogether different.
The issue is what I reported to Joshua a day or two ago. I added that to my PS on the blog- and I am not sure when you looked at this post to know if you saw it or not.
I believe we MUST report all adverse events- but through proper channels. Too many people think they have an adverse affect (like those who complain about inoculations, or paralysis that comes from taking a medication (most of which are true events, but not related to the medicine involved). That’s why an investigation is warranted. Posting this on Facebook is not the way to start the ball rolling.
Thanks for your visit!
Roy