Social Media Clinical Research: Transformative or "A Taste of Armageddon"?

Social Media Clinical Research: Transformative or "A Taste of Armageddon"?

This tweet from my friend @Frank_Antwerpes, CEO at DocCheck (a German online physician community), appeared in my Twitter stream today:

Clinical Research goes social Web: http://bit.ly/kNCHop

If you follow the link, you will find this published study: "Accelerated clinical discovery using self-reported patient data collected online and a patient-matching algorithm". Here's the abstract:

Patients with serious diseases may experiment with drugs that have not received regulatory approval. Online patient communities structured around quantitative outcome data have the potential to provide an observational environment to monitor such drug usage and its consequences. Here we describe an analysis of data reported on the website PatientsLikeMe by patients with amyotrophic lateral sclerosis (ALS) who experimented with lithium carbonate treatment. To reduce potential bias owing to lack of randomization, we developed an algorithm to match 149 treated patients to multiple controls (447 total) based on the progression of their disease course. At 12 months after treatment, we found no effect of lithium on disease progression. Although observational studies using unblinded data are not a substitute for double-blind randomized control trials, this study reached the same conclusion as subsequent randomized trials, suggesting that data reported by patients over the internet may be useful for accelerating clinical discovery and evaluating the effectiveness of drugs already in use.

Pretty interesting, but also frightening.

This InformationWeek story presented the five advantages outlined by the authors of the study:

1. Speed. It took only nine months from initiation of the tool (March 2008) to the first public sharing of preliminary results (December 2008).
2. Patient access. There is a potential to rapidly recruit widely dispersed patients with rare conditions and to overcome selection bias favoring patients living near specialist centers.
3. Availability of control participants. Clinical outcome data were passively collected from thousands of patients who served as potential matched controls.
4. Cost. Online studies have lower marginal costs per patient as compared with thousands of dollars per patient in traditional trials.
5. Patient engagement. Patients who submitted data using the PatientsLikeMe website were connected with other patients, which may have a range of benefits.

InformationWeek did NOT list the inherent LIMITATIONS mentioned by the authors. The most important limitation cited by the authors: "Unlike randomized trials, which match the comparison groups on all possible confounding factors, subject only to chance variation, observational studies cannot control for unmeasured covariates."

In the PatientsLikeMe press release, PatientsLikeMe Co-Founder Jamie Heywood stated:

"The rising costs of healthcare and increasing complexity of managing disease require new approaches to comparative effectiveness research and real time management of disease. While there is much work to do, we have demonstrated a patient-centric approach that provides dramatic cost and time advantages."

In these days of budget cuts and R&D cutbacks, pharmaceutical companies may jump on the "Social Media Clinical Research" bandwagon. Some day -- probably not in my lifetime -- FDA may even accept results of such studies as part of the drug approval process. Drug companies, for example, may lobby the FDA to accept such studies as fulfilling post-marketing surveillance requirements imposed on them.

Thinking about the possibilities reminded me of a classic Star Trek episode titled "A Taste of Armageddon."

In that episode, the starship USS Enterprise, under the command of Captain James T. Kirk, sends a landing party to Vendikar, a city on the planet Eminiar VII. Kirk is informed that a fusion bomb just struck the city and killed half a million people. Curiously, everything in the city seems intact and there is no visible evidence or sensor readings of such an attack ever occurring. The landing party soon discovers that the entire war between the two planets is completely simulated by computers which launch wargame attacks and counterattacks, then calculate damage and select the dead. When a citizen is reported as "killed", they must submit themselves for termination by stepping inside a disintegration booth.

The advantages of computer-simulated war are similar to the advantages PatientsLikeMe noted for its Social Media Clinical Research. I imagine the most important advantage of such a computer-simulated war is COST savings! Speed also would be an advantage -- wars can be fought over a period of months rather than years. Access to and engagement of citizens seems to have been solved by the denizens of Eminiar VII. Controls are NOT necessary in warfare.

When researchers land on social communities such as PatientsLikeMe, they may also encounter anomalies such as reports of cures, side effects, trial results, etc. that conflict with "visible evidence or sensor readings," ie, scientific reality.

To which I say:

SOCIAL MEDIA, THE FINAL FRONTIER! ...of clinical research.

Data Mining in the Deep, Dark Social Networks of Patients. Word to Pharma: Caveat Emptor

Data Mining in the Deep, Dark Social Networks of Patients. Word to Pharma: Caveat Emptor

Yesterday, I posted the following tweet:

PatientsLikeMe blocks "scraper." Is this a trend in SM? Pharma can't mine patient msgs & learn? See http://bit.ly/9lWSIT #fdasm #hcsm

Eventually, that tweet reached the desktop of Jamie Heywood, Co-founder of PatientsLikeMe (PLM), who contacted me to discuss the "richer story" beneath the surface.

But before I get to that, here's how Jamie's partner, Ben Heywood, described what was going on viz-a-viz the "scraper" incident (see here for his full statement):

"Recently, we suspended a user who registered as a patient in the Mood community. This user was not a patient, but rather a computer program that scrapes (i.e. reads and stores) forum information. Our system, which alerts us when an account has looked at too many posts or too many patient profiles within a specified time interval, detected the user. We have verified the account was linked to a major media monitoring company, and we have since sent a cease and desist letter to its executives.

"While this was not a security breach, it was a clear violation of our User Agreement (which expressly forbids this type of activity) and, more significantly, a violation of the community’s trust. Your Account Information (e.g. your names and emails) was NOT in danger of being stolen. It is likely that the forum information that was “scraped” would be sold as part of that company’s Internet monitoring product. In fact, we sell a similar service, PatientsLikeMeListen^TM, to our clients so they better understand the voice of the patient."

The important issues for PLM is that the media monitoring company -- probably employed by an unnamed pharmaceutical company -- was not an authentic patient and violated PLM's User Agreement, which states "You may not use any robot, spider, scraper, or other automated means to access the Site or content or services provided on the Site for any purposes."

Recently, I wrote about BzzAgent operatives trolling social media on behalf of pharmaceutical companies (see "Are J&J Agents Trolling for Adverse Events on the Internet?"). One "operative" admitted that he took a survey through BzzAgent for Johnson & Johnson, "which basically was more of a 'contract' where if chosen, I agreed to notify J&J if I became aware of any negative talk about their products."

What this person was doing for J&J was not exactly "scraping" social media patient sites because the monitoring was being done manually by a real person. This may be a neat way of getting around User Agreements of "closed" patient communities like PLM, but it is not nearly as efficient or effective as using software tools (listen the podcast "Aligning Your Message with Patient Needs: How Social Media Can Help" for more insight on that). But, if J&J enlisted the help of thousands of real people to monitor patient communities, it could be pretty effective. BTW, PLM's policy also forbids individuals from using information collected manually or otherwise on PLM "in connection with any commercial endeavors."

Since PLM is using its own "scraper" software to troll its closed communities to create reports for pharma clients (eg, see "PatientsLikeMe Reports High Rate of Adverse Event Reporting Among Its Members"), it has a vested interest in preventing rouge pharma companies from hiring "scraper" agents to mine PLM for the same data it is selling its own pharma clients.

This whole "scraping" incident raises the issue of "Transparency, Openness and Privacy." Anyone can join PLM and claim to be a patient -- we are ALL patients at one time or another. So, when I joined, I was not violating PLM's User Agreement, which also states "To become a member and access the area on this Site reserved for members (the 'Member Area'), PatientsLikeMe requires that you are either (a) a diagnosed patient of the particular community you are joining, (b) a caregiver for a patient eligible to join such community, (c) a health care professional (e.g. doctor, nurse, health researcher, etc.), or (d) a guest as authorized by a PatientsLikeMe member or employee." That includes practically everyone in the known inhabited universe.

Someone "posing as a patient" on PLM is practically an oxymoron (or whatever the term). Therefore, violation of "openness" is not the issue. "Privacy" is also not the issue. PLM members are well aware that whatever they say in PLM's "closed" communities can be revealed to third parties either by PLM itself (de-identified) or by other PLM members (as part of a non-commercial endeavor).

"Transparency" appears to be the major issue here, and one that pharmaceutical companies should be wary of when they hire agents to monitor patient communities. Jamie likened it to a situation in the real world where his church's copper gutters were stolen and the copper resold to people having repairs done on their houses. The end users of the stolen copper may not have known how it was obtained, nor did they probably care. Pharma companies, however, cannot be so blase -- they have a lot more at stake if they accept stolen "copper" and get caught. As Jamie said, you wouldn't want to see that story in the Wall Street Journal (or here on this blog).

The lesson for pharma companies is "caveat emptor" -- when hiring a third party to monitor "closed" patient social networks, be sure they do not violate the policies of these communities and/or do it in an open and transparent way.  For communities like PLM, the only way is to hire PLM to do the scraping for you (ie, see "UCB & PatientsLikeMe: Embracing Social Media, Adverse Events Included!").

[BTW, I'd like to see a pledge not to violate policies of patient social networks as part of every pharma company's social media principles. AstraZeneca, for example, might consider adding it to its "five important principles for online dialogue" (see "Transparency and Trust in Health Communications," posted by Bob Perkins, Vice President, Public Policy, AstraZeneca, on AZ Health Connections Blog).]

PLM community members, BTW, seem to be OK with PLM's sale of information to third parties: "I can live with you selling the information as long as you continue to reinvest in the infrastructure of the site and keep it more than just up to date," said one person in a comment to Ben's post. "Cutting edge is what I have found here and I expect you will still provide this."

You are probably asking yourself "Is John Mack OK with it?" Well, it's not something I would do. But it's a valid business model that provides useful information to clients. As I mention below, however, I think PLM should  also open the door to its proprietary database for the public good -- for free.

Now, let's discuss the "dark" aspect of all this.

"Closed communities" like the member areas of PLM are "dark" to search engine spiders, which are forbidden to troll these areas of PLM and index the content. There are technical ways of doing this, but most search engines agree to abide by requests that certain domains not be indexed.

This is something known as the Dark Net or Deep Web. According to wikipedia, "searching on the Internet today can be compared to dragging a net across the surface of the ocean; a great deal may be caught in the net, but there is a wealth of information that is deep and therefore missed. Most of the Web's information is buried far down on dynamically generated sites, and standard search engines do not find it. Traditional search engines cannot 'see' or retrieve content in the deep Web -- those pages do not exist until they are created dynamically as the result of a specific search. The deep Web is several orders of magnitude larger than the surface Web."

Most pages in forums like those on PLM are dynamically generated. However, it is possible to flip a "switch" that allows the page to be indexed (don't ask me how this works; I only know it's possible because I use such a switch on the Pharma Marketing Network Discussion Forums).

What this all means is that, potentially, much of the best patient-generated information found on social networks is "dark" to pharma companies unless the owners of these communities flip that "switch" or allow pharma marketers access (paid or otherwise). Hopefully, however, these sites might also perform a FREE public service such as what I talked about in this post: "If Patients Know Best, then Patient Social Networks Can Help Capture and Report AEs"

If Patients Know Best, then Patient Social Networks Can Help Capture and Report AEs

If Patients Know Best, then Patient Social Networks Can Help Capture and Report AEs

A recent article published in the New York Times caught my attention. The article -- "In Reporting Symptoms, Don’t Patients Know Best?" (find it here) -- suggested that doctors tend to "downgrade symptoms" (ie, adverse effects of drugs) reported to them by their patients because of "wishful thinking" or, worse, because they do not want to document problems they failed to act on for fear of being sued.

That being the case, there is little hope that widespread use of electronic medical records will capture useful adverse events that the FDA can analyze. Garbage in, garbage out as they say.

Speaking of garbage, the article criticized FDA's MedWatch program that allows doctors and patients to report problems that they think are adverse events from drugs already on the market. "But it’s a passive system that waits for reports instead of actively surveying patients," says the article. "Many people don’t know about it, and it has failed to catch some important adverse events," said Dr. Ethan Basch, an oncologist who treats men with prostate cancer and does research at Memorial Sloan-Kettering Cancer Center in New York.

"A better approach," says Basch, "would be to have large numbers of patients filling out questionnaires before and after drugs are marketed. For example, in the postmarket setting we could ask 5,000 selected patients starting Bextra to report monthly."

Of course, Bextra has been taken off the market by the FDA. Dr. Bach's point is that if post marketing surveys of patients were done soon after Bextra entered the market, the problems may have been noticed much earlier.

Meanwhile, Dr. Basch is working on his idea: "Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events" is National Cancer Institute funded outcomes Research project that began in October 2008 (see here). As part of that research, Dr. Basch and his co-investigators initiated development of an electronic patient-reported system for monitoring and reporting symptomatic AEs that patients may experience during treatment.

I imagine that this system would be pretty expensive to implement on a large scale across many different drug treatments. But there is a cheap (ie, FREE) electronic system already available for capturing adverse events from patients: patient-focused social media sites such as PatientsLikeMe (PLM) and others.

PLM found that 7% of 500 randomly selected posts from the 364,000 posts contributed by patients within the PatientsLikeMe Forum during 2009 incorporated all four elements required for reporting an adverse event (an identifiable patient, a specific medication, an identifiable reporter and a reaction). This is 35 times the rate in the frequently cited Nielson study, which found only one such message in its random sample of 500 posts. (See "PatientsLikeMe Reports High Rate of Adverse Event Reporting Among Its Members".)

I'm not sure how Dr. Basch is getting his questionnaire out to patients, but he might look to social media sites like PatientsLikeMe to perform a public service and place the form on its site so that patients can easily access it. Just a thought on how social media can help expedite outcomes research!

NOTE: I will be speaking on this topic next week at the World Drug Safety Congress. The title of my presentation is "Web based AE reporting; is it the future?" I will specifically address how social media can be incorporated into a drug’s safety strategy and the challenges involved. If you have any solutions, ideas, or comments I can incorporate into my presentation, please tell me about them (you can email me at editor@news.pharma-mkting.com).