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November 02, 2009

FDA and social media: The regulated community's current obsession overlooks off-label promotions by the advocacy community

This morning I received a tweet exhorting me to learn about Low Dose Naltrexone (LDN) for autoimmune diseases.  (Naltrexone, by the way, is approved by the FDA only to treat alcoholism.)  Within a few clicks, I found claims that LDN would be a good drug to take for dozens of conditions: everything from neuroblastoma to HIV to celiac disease, and learned of a network of tweeps promoting LDN. 

The above tweet linked to a blog promoting LDN which is part of the Health Central community.

All this got me thinking about a bunch of issues; for instance:

  • Does the promotion of off-label uses by a member blog comply with the HON Code, which has been adopted by Health Central?
  • Since folks are already using social media to promote off-label uses of prescription medications, what are, and what should be, the obligations of pharma companies to address the information put out by such folks?
  • Should we expect any of those obligations to change post-#FDASM (i.e., after the much-anticipated public hearing at the FDA on the use of social media in pharma marketing and subsequent anticipated rulemaking)?   

Well, marketing of drugs for off-label uses is supposed to follow certain FDA rules -- not very restrictive, and essentially self-policed, since the rules just say that only medical journal articles on off-label uses may be shared with docs. Of course, some drug reps cross the line, and one pharma company -- Allergan, the maker of Botox -- is seeking to have even these limits lifted as unconstitutional limits on free speech.  These rules apply to the pharma companies' reps, not independent bloggers, of course, but the HON Code (which ought to apply, given the Health Central endorsement of the blog in question) ought to impose some relevant standards.  Consider  Principle 5 - Justification of claims:

All information about the benefits or performance of any treatment (medical and/or surgical), commercial product or service are considered as claims. All claims have to be backed up with scientific evidence (medical journals, reports or others).

Pharma's concern about content created by others but posted on a pharma company web site or blog or other social media site should perhaps be extended to a concern about content posted by others on other sites.  Both may be found just as easily, given the plethora of web search and alert tools now available.  I am not suggesting that pharma companies be called upon to monitor the entire internet; rather, perhaps the time has come to create firmer rules about promotion of off-label uses of prescription drugs, to be enforced by state and federal authorities.

Without waiting for the public hearing to be completed and rules to be written (which could take a year), many pharma companies have already established a social media presence.  While the manner in which they use the medium is a topic for another day, we should expect at least some of them to become more actively engaged in social media in the future.  

David Harlow
The Harlow Group LLC
Health Care Law and Consulting


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If there is no profit to be made on these off-label drugs by either the drug "big-Pharma" companies or by "big Pharma"-Lawyers like yourself I can see how you would want to stop the spread of information to the masses. Do you realize that LDN which costs $1.00/day can actually provide more relief and promote healing for people with autoimmune diseases, whereas the big drug companies serve up drugs which cost $100,000.00 + /a year and carry a host of risks to the people who take them which could cost them their life. The FDA has approved Naltrexone for over 30 years and has deemed it safe even in high doses. They are even regulating many of the clinical trials that are using Low Dose Naltrexone (LDN) which is being used to help people with autoimmune diseases. You need to do more homework, pull up a list of clinical trials being conducted around the nation and you'll see it's legit.

Thank you for your comment. I'm glad that your son is responding well to LDN as part of a clinical trial. As you know, trials are designed to test the safety and efficacy of drugs across a population, vs anecdotal evidence. The point of my post was to wonder aloud about the appropriateness of online promotion of off-label uses of drugs and the responsibilities of pharma companies in initiating / monitoring / correcting such information. I wrote about LDN only because I received an unsolicited message yesterday promoting its off-label use. I take it you believe that promotion of LDN for off-label uses is appropriate, based on your experience. The issue is joined for me in part because it is being promoted for use in patients with several dozen seemingly unrelated conditions. I would be very interested in the results of clinical trials testing these hypotheses, or even "quick-and-dirty" analyses such as those enabled by websites such as

I open the question to others as well: What would be a responsible approach to communicating about off-label uses via social media?

I found out about LDN 4 years ago when my son was first diagnosed. Not from my sons doctor but from my own research. I searched every media channel out there for information on the pros and cons of both traditional and alternative treatment protocols being used to treat Crohn's. I read online medical journals from a multitude of countries, minutes from the EU global health symposium meetings, the agricultural journals which discussed the probability that the disease comes from animals, etc. I called researchers around the world to find out new treatments and I scoured the user blogs for 'real people" experiences in treating their own disease using traditional and alternative meds.. When I came across LDN, It was being used in a clinical trial for adults and was found to be an amazing drug with countless benefits. So when I found a trial had opened for kids 3 years later, I quickly got my son enrolled and he is doing amazing today.
A person needs to be their own health advocate and educate themselves as to the pros and cons of all medications, alternative and mainstream. Since LDN offers no gold lining of the pharmaceutical companies profit margins you can very well understand their reluctancy to jump on the band wagon and promote its use to people with autoimmune diseases. But if you check out the online communities of people with MS, crohns, autism etc, you will find that this drug is helping thousands of people.
You were suggesting that this spread of information not pre-authorized by some legal mumbo-jumbo from the higher ranks needs to be regulated. I'm sure that would work in some countries, but remember this is indeed AMERICA. Let freedom of speech live on. Please.


FDA is indeed thinking about third party content and how it should be potentially regulated. Its requests for comments in its meeting notice for the November public meeting includes emphasis on when pharma companies should correct third party content and how and to what extent pharma companies influence otherwise third-party content. FDA's view on influence and liability is beyond compensation and sponsorship but a broader concept of "influence." Generally, FDA enforces its misbranding provisions against manufacturers and license holders and commercial interests. Sometimes, HCPs(third parties) also get cited for misbranding, but this is usually related to some interests or consulting that they have with a company.

Also, FDA's rules on off-label promotion are indeed foggy in some areas but are enforced pretty effectively in a number of ways today. The DOJ in cooperation with FDA are extracting record breaking settlements for off-label cases right now which also result in corporate integrity agreements against the company with specific and prescriptive requirements for policies and procedures to guard against off-label promotion. FDA's reprint guidance is a very narrow window for companies to get through as well. Further, it is not the only way for companies to communicate off-label information. There are provisions in FDA's IND regulations that permit certain scientific communications (including off-label) and a safe harbor for medical responses to unsolicited requests.

Nonetheless, your point about there being many more dimensions to the issue is well taken. Most people who are engaging in the current dialogue have only a vague understanding of where this might all be going (including perhaps even me).

John Murray

Thanks for your perspective, John - and your candor! This really is terra incognita.

David -

You make some great comments.

One of the strengths of the Web 2.0 and social networking phenomenon is that it gives all people an equal voice. Everybody, from the patient with a single experience to a physician or scientist with knowledge of large studies gets to weigh in.

But - one of the weakness of the Web 2.0 and social networking phenomenae is that it gives all people an equal voice. In some ways, this serves to destroy the weighting we naturally give to information, and fosters the propagation of less than evidence based opinions. In normal interaction, people have a strong tendecy to weight information based where it comes from. One tends to trust a chemist about chemistry, a doctor about medicine, and your hair stylist about hair product, as they have spent their lives studying their area of expertise. In normal media, these experts have the advantage over non-experts in spreading their knowledge. ie. the local news station has on a local cardiologist to discuss heart disease rather than the local hairdresser.

The internet, and social media in particular, has no editor, and people love this. Note the explosion of digg and sites like it, where news is created by the masses, without any central control. The Wisdom of Crowds is one of the big strengths of the internet, but it also comes with some disadvantages. Social networking has no editor, and as such runs into problems that mainstream media would never have. The producer of a news show would never allow a hairdresser to come on and talk about cardiology in the medicine segment on the news, but that hairdresser could certainly do that on their blog and have an audience. In fact, attribution bias leads people who come to their favorite hairdresser's hair blog to read about hair to give equal weight to their hairdresser's opinions about cardiology, even though they would never initially seek that information from that person.

Furthermore, people with radical ideas have flocked to the internet to spread them, as they have been appropriately shut out of traditional media by the editors and producers of that media. In some cases, this has led to leak of previously fringe ideas into mainstream thought. A great example of this is a growing and completely baseless distrust of vaccines, started primarily in blogs and the Twitterverse.

So the point about third party information about FDA approved drugs is well taken. It would be reasonable for pharma to send out tweets from time to time in response to others mentioning their drugs, directing people to the mainstream information. There needs to be a force within social networking that pushes mainstream evidence based thought, not necessarily to combat the fringe, but at least to make sure people know what mainstream thought is. Then, they can decide who to trust and what to believe. Right now mainstream is too quiet, and the fringe is winning more than ever before.

Nicholas Fogelson, MD

Nicholas -- Thanks for your comment. Here's one back at you: What if the hairdresser has just been through a months-long experience of cardiology diagnoses and treatments for her father and has educated herself thoroughly about all of the issues, treatments, drugs, research, etc. relevant to her father's particular condition. At that point, is she not an e-patient, engaged in participatory medicine? I have come to believe that some of the wisdom she has gained through that process will shine through and allow her posts to be more highly valued than other, uninformed, material posted on the web.

Absolutely. As I mentioned, one of the strengths of the internet is that it gives everybody a voice.

But as a physician, my experience is that for every 10 people who have spent a great deal of time learning about their condition or a condition of their family member, less than half ever get a real understanding of what is going on, and many develop serious and sometimes unshakable misunderstandings about their disease process. Often this is because a great deal of their research comes from poor sources, and they cannot be convinced of this.

Ultimately it comes down to whether or not someone with no real medical background is capable of becoming "thoroughly educated about all the issues" as you put it. It think it is possible, but is very rare. It takes four years of medical school and years of specialty training for a physician to become "thoroughly educated about all the issues". A few months of seeing one person have a disease or having it yourself and reading some internet sources does not come even close to this. Even physicians have trouble becoming "thoroughly educated about all the issues" when something is outside of their specialty. The good thing is that most physicians realize this enough to not even try. They just find a physician they trust and well, trust them.

What bugs me is that a lot of people will take offense to the above statement; but they would not take offense to the idea that the person building their own home will never understand homebuilding like the contractor does, or that the person sending in their car for repair may never understand the car like the mechanic does. But somehow people think they should understand human physiology and medicine better than the physician does.

The problem with internet medical sources, is that the people who really understand the issues of science and medicine are predominantly practicing their craft, and don't have a great deal of time to post on forums. As such, the majority of "medical" information on the internet is created by non-experts, and thus a substantial selection bias is present. Inaccurate information tends to populate the internet but the people with inaccurate information have more time to post than the real experts.

I think it is great that the above poster's child is doing well on LDN for his Chrohn's disease! Hopefully the trial he is a part of will demonstrate effectiveness of the drug, and it can become a part of mainstream medicine. But I also recognize that the anecdotal experience of one person is not evidence in and of itself; ergo the need for the trial her son is in.

Demanding such evidence prior to mainstream acceptance of a treatment is not holding truth back. Its defining reality before misinformation can take hold. There are so many places in medicine where standards of care have been established prior to real study, and in many cases we have ensconced things later proven to be unhelpful or even harmful. One would think that it should be easy to get these things out of practice, but actually its very difficult. In my own field, fetal monitoring in labor is absolutely entrenched, yet all evidence points to its ineffectiveness in preventing bad outcomes and its tendency to increase cesarean section rates. But because it is an accepted standard of care, it will never go away.

Low dose Naltrexone has great promise, and may very well become a standard of care. But for now, it is being researched. Not until real science and statistics can show that it really works will it become mainstream, and that's they way it should be.

I want to put in a plug for the person building their own home (versus the expert contractor). Yes, the contractor will have mastered certain necessary skills and maybe do the job more safely and efficiently (though perhaps prioritizing his/her own safety and efficiency over that of the family living in the home). But the DIY home builder knows how she and her family live, what kind of space they need, the right balance of structure and comfort, and what's "livable" in her individual circumstance. And she might use durable materials rather than whatever is cheap, available, or pushed by sales reps. Of course, some DIY homebuilders won't bring nearly that level of deliberation to the matter or might royally mess up the job, and some contractors will do masterful work that the DIY homebuilder could never equal, but plenty of those motivated, informed DIYers will have way better homes than if they had passively turned the entire job over to experts. (It should also be noted, plenty of DIY home builders will bring in experts for parts of the job that require specialized skills, electrical work, for example.)

(Sorry, this really is the analogy that keeps on giving...)

All of that is to say, of course, that *some* patients will get much better outcomes if they engage in their care, or even "manage" their own care and decide for themselves if/when they need medical advice or treatment. The question is how to use social media and other technology to optimize "effective" e-patient behavior while mitigating, managing, or simply drowning out the potentially harmful media.

It's interesting that you mention continuous fetal monitoring as something that is here to stay. I, for one, am extremely eager to see what EFM's fate will be now that any woman can instantly find any number of credible information sources saying that it's routine use harms women and doesn't benefit babies. Just a few years ago, that was pretty privileged information.

Yes, it is definitely difficult to get doctors and nurses to stop relying on a technology to which they've grown accustomed, or to reduce consumer demand for it once you've crowned it the standard of care, or to otherwise curb overuse and misuse. But I think the internet is changing the nature of evidence and of evidence-based practice, and we don't yet know how practice standards will be determined in the future, or if the concept of "practice standards" will even exist.

This is a very interesting discussion. I had to recreate your journey from tweet to blog to website and have a few observations. The tweet sent you to the blog "Honest Medicine" which provided a place from which to download the LDN ebook. "Honest Medicine" proudly displays the Wellsphere badge in its sidebar. (Side note: this badge is practically meaningless as basically everybody with a health-related blog was invited to have their posts republished on Wellsphere.)

Wellsphere does not feature the HONcode logo nor does it appear to be a certified site. Wellsphere is now owned by HealthCentral which does display the HONcode logo and is a certified site. I do not see how the HONcode would extend to due to its ownership by HealthCentral.

Besides the discussion of HONcode, this issue is more about discussions of off-label drug usage. I am a writer for HealthCentral on both the MS and RA sites. I am quite conscious of my responsibilites as an individual patient who educates our community about living with MS. The only medications which are FDA-approved for use in MS are the disease-modifying drugs. None of the drugs we use for symptomatic relief are FDA-approved for that specific indication.

As a patient advocate and educator, I have discussed recommended pharmacological treatments for various common symptoms associated with MS. For example, see a discussion of MS fatigue here -

Does this example abide by the HONcode principles? You tell me, I've not thought about that before.

Now, I frequently get approached about the benefits of LDN; sometimes with the solicitor expressing pity on me that I would choose to use expensive, toxic medications to try to slow down my disease. This attitude does not help their cause (imho) but I am glad to see that studies using LDN are being executed as we speak.

Lisa --

Quick clarification: the blog I referred to has a Health Central badge on it, just above the Wellsphere badge.

The question you raise about your own blogging is an interesting one. The post you linked to includes recommended off-label uses of FDA-approved drugs, and the post as a whole is very measured, and explicit about the fact that these uses are not FDA-approved. Reading the HON Code principles as written, though, you have made a "claim" that perhaps needs to be "backed up with scientific evidence." That is defined by reference to another part of the HON Code, which says (Principle 4): "All sources of the medical content must be given. You have to clearly indicate the recognized, scientific or official sources of health information quoted in your articles. If you used another website, a book, an article, a database or any other support, it has to be specified. You have to provide a precise link to the source, whenever it is possible and the references should be in relation with the content referred." Seems to me you need some backup for the off-label uses, rather than linking to info about FDA-approved uses of the drugs in question. Mind you, these thoughts are based on a read of the HON Code principles, taking them at face value, and not based on any deep familiarity with these principles or how HON applies them. I'd be interested to hear from anyone out there who has more knowledge about HON's inner workings.

Oh, I didn't even notice the other badge as it doesn't have the current "healthcentral" look to it. LOL. Sorry about that. HealthCentral hasn't been giving awards like this since 2007 (to my knowledge).

In regard to your observation of the post I linked to, at the end of it I list my source and places where one could go for further information. The source ( is presented by the National MS Society as an Expert Opinion Paper geared towards physicians who treat patients with MS. I do not recall if I actively linked to the specific drug information or if my producer did. Either way, the intention was to provide information about the drug itself not about approved uses.

If there were studies available to show the effectiveness of these medications for the off-label use in MS symptomatic treatment, I would link to them as well. But their usage is common knowledge and accepted medical practice.

I find this topic interesting as it brings up some issues which those of us who freelance for HealthCentral should be aware of (perhaps). On a personal level, I just try to make the information understandable and useful to the typical patient. I'm not thinking of FDA rules when I do that and am only trying to be as accurate and ethical as I can.

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