GSK, National Headache Foundation and "Migraine Diary." Is There an App for That?

GSK, National Headache Foundation and "Migraine Diary." Is There an App for That?

Last week I came across this tweet posted by @GSKUS:

RT @NHF: Need help remembering your #migraines details? Find an online migraine diary from @GSKUS at http://bit.ly/hBS98Q

For my Twitter-challenged readers, I should point out that "RT" signifies that @GSKUS "retweeeted" a tweet originally made by @NHF, which is the Twitter account of the National Headache Foundation.

Whenever a pharma company retweets a message from a third party, it raises some flags. For example, suppose NHF was a patient advocacy organization that promoted off-label use of medications and suppose those medications were marketed by GSK? Further, what if GSK helps support NHF with funding? What if NHF received the majority of its funds from GSK? What if NHF was actually created by GSK and not independent at all?

I am asking these questions because I have previously cited the close relationship between GSK and a supposedly independent Restless Leg Syndrome patient advocacy organization (see Pharma Dollars (Pounds, Euros) are Grassroots Seeds).

These days there are quite a few tools I can use to answer my questions. But, first, let's look at the link in the tweet.

When you click on the http://bit.ly/hBS98Q link in the GSKUS tweet, you discover that the real link is http://www.lowerthepain.com/pdf/Migraine_Diary.pdf. The "Lower The Pain" website (www.lowerthepain.com) is a GSK site that prominently promotes a migraine survey. "Editorial and other support for the survey provided by National Headache Foundation with funding, development, and other support provided by GlaxoSmithKline," says GSK on the site. See this Fact Sheet on the NHF site for more about the survey.

But I also see an invitation to get "tips & tools you need that may enhance your conversation with your doctor today." Right NEXT to that is a picture of an iPhone, which GSK is careful to point out is a registered trademark of Apple Inc.

When I click on "Tools to Help" I am brought to the following screen:

This further HINTS that there is an app for that (ie, "MIGRAINE DIARY").

So, is there an iPhone version of the Migraine Diary?

Yes, there IS an iPhone "Migraine Diary," BUT it does NOT appear to be a GSK app or an NHF app. Here's the app by that name that I found on iTunes:

This is a nice little app, but it does NOT resemble the GSK's PDF version of "Migraine Diary."

The iPhone app was developed by Net Workz LLC, a Software Engineering Firm located in the UK, which is the only connection I can see between it and GSK. In fact, the creator of the app is Aaron Douglas. His about page states that "Net Workz LLC is a small company I started that I use for anything I do geeky-related. I don’t have much content here but I plan on expanding this site soon. My full time job employs me as a software engineer. This place is for my personal projects that need to be legit, like iPhone Apps."

Maybe GSK and Douglas are negotiating a deal right now to allow "Migraine Diary" to "go legit."

The only comment Douglas has received about his app is this:

"I like this app. It's not the fanciest, but I wanted something easy to fill out when I'm in pain! The only problem I have is that sometimes when I add a journal entry, it only shows up when I turn it off then on again, but it is there. I wish it had more graphs to see more than one month, to see a patten. An option for an "all day" headache instead of having to put in a time would be good!"

OK, so what about the relationship between GSK and NHF? There's obviously the survey mentioned above. There's a guest post to GSK's blog by Merle L. Diamond, MD entitled "Teaming up to Close the Gap in Doctor-Patient Migraine Communication" (see here). "Dr. Merle L. Diamond was compensated by GlaxoSmithKline for her participation in this campaign," GSK disclosed. Dr. Diamond is a member of the NHF board of directors.

Dr. Diamond is daughter to Seymour Diamond M.D., Executive Chairman of NHF, who originally founded the National Migraine Foundation, which was renamed the National Headache Foundation in 1987.

Seymour Diamond is the also the founder of Diamond Headache Clinic and Merle Diamond is it's president.

I'm not going to track this much further, but it would be interesting to know how many other physicians involved with NHF and the Diamond Headache Clinic are on GSK's payroll. Now that GSK has been required to list all payments to physicians, it should be easy to find out.

OK, I will track this a bit further. I just downloaded NHF's 2009 IRS Form 990, which has some interesting tidbits an accountant may be able to dechiper.

I notice, for example, that NHF made a "gift" of $1,112,748 to the Seymour Diamond Fellowship Fund [of] the Diamond Headache Clinic Research and Education Foundation. Are the Diamonds using the NHF as their personal piggy bank?

Also, NHF paid $814,955 to Vedanta Associates Inc., an independent contractor, for "research on various projects and programs." Seems like a lot of money for "research." What I've been able to find out about Vedanta Associates is it "provides marketing research and medical communications solutions to the pharmaceutical and heathcare industry."

PHARMA Co Patient Opinion Leader Programs

PHARMA Co Patient Opinion Leader Programs

[Below is a blog post that someday SOON may appear on a PHARMA Co Blog such as AZ Health Connections, which recently posted a notice about "AstraZeneca And Doctor Speakers Programs" (read it here). I substituted "patient" for "physician" in the following post to illustrate a point.

In this new social media era, where there is much discussion about pharma participating in patient discussions online, there is a possibility that pharma will hire influential online patients to act as "opinion leaders" just as they have hired physicians to be key opinion leaders (KOLs). Patients have already been hired by pharma companies and their agents to troll patient sites for comments made by patients online (see, for example, "Did J&J Troll Social Media Sites to Ensure Its Motrin "Recall" was a Secret?")].

Beginning soon, news organizations will be publishing a series of stories examining the financial relationships between patients and the pharmaceutical industry. Their focus will be on payments made to patients who serve as “social media moderators” or "opinion leaders" on behalf of companies and their medicines.

PHARMA Co would like to provide our perspective on the issue by having Marie M. – PHARMA Co’s US compliance officer – answer the key questions we’ll be asked by reporters in coming years.

Why does PHARMA Co engage with patients as moderators/opinion leaders?
Marie: PHARMA Co works with online patient opinion leaders (POLs) or moderators to provide other patients online with accurate and balanced information about the use, safety, benefits and risks of our medicines. POLs have the expertise and credibility necessary to educate colleagues to ensure they have the information they need to make informed treatment decisions.

Patients ultimately benefit when they are well informed and knowledgeable about our medicines, treatment options and standards of care.

Why does PHARMA Co pay patients to participate?
Marie: It is appropriate to compensate POLs for the time they dedicate to providing information to other patients about our medicines and who act as moderators of our online discussion boards. Patients who tweet or post information online about our medicines are compensated at a fair market value based on their qualifications and the amount of time they dedicate to the task. We never pay patients in exchange as an incentive to promote our products.

There currently is NO cap on how much each POL can receive from PHARMA Co each year.

How does PHARMA Co ensure laws and industry policies are followed?
Marie: Before a POL can tweet or post information on our behalf online, they must participate in extensive training on our medicines, policies, and the laws and regulations that apply to industry-sponsored presentations. Actually, however, there are NO laws and regulations that apply to industry-sponsored tweets and posts made by patients online. But, be assured, our policies prevent the company from paying POLs in exchange for asking their physicians to prescribe our medicines or as an incentive to promote our products.

How does PHARMA Co select patient opinion leaders?
Marie: There are several criteria that PHARMA Co evaluates when a patient is nominated to be a tweeter or online poster on behalf of the company, including positions within leading online patient social networks, national patient advocacy organizations; membership in special patient opinion leader networks such as WEGO; consistent tweeting and posting records; participation in research trials; and regularly tweets or posts information online.

Consumer Advocates Step Up and Submit Comments to FDA Regarding Regulation of Social Media

Consumer Advocates Step Up and Submit Comments to FDA Regarding Regulation of Social Media

The deadline has come and gone for submitting comments to docket FDA-2009-N-0441 regarding "Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools." You can find ALL of the comments here at Regulations.gov and easily download MOST of them here at fdaSM.com. Unfortunately, the latter does NOT include text comments that were submitted by individuals. You can find these at the end of this post.

Seventy (70) different entities submitted one or more comments to the docket. These submitters can be organized into the following eight general categories:

1. HCP Org - Health Professional (HP) or HP Assn
2. Search Engine - Google and Yahoo!
3. Trade Media - Blog, newsletter, publication focused on drug industry news
4. Pharma Company - Drug, device, or diagnostic company
5. Consumer Advocate - Individual or consumer advocacy group
6. Industry Advocate - Trade association or ad hoc group
7. Health Website - Patient, physician, or health activist focus
8. Industry Service Provider - Marketing, communications, ad or PR agency that provides services to drug industry

Here's the pie chart representing the distribution (click on it for enlarged view):

I also compared the types of entity that submitted comments to those that made presentations at the November 2009 public hearing. Of course, there was some overlap because many did both. Here is the bar chart showing the comparison:

(See "Industry Groups will Eat Consumer Advocates' Lunch at FDA Social Media Public Hearing" for my analysis of entities that made presentations at the public hearing.)

It's immediately obvious that there is a more even distribution among commentators than among presenters. Whereas only 7% of presenters at the public hearing were pharma companies, 21% of commentators were pharma companies. Pharma obviously played it close to the vest and many companies decided not to be in the limelight at the public hearing but waited until the very last minute to submit comments to the docket.

Consumer Advocates also stepped up to provide comments, whereas very few made presentations at the public hearing. As I suggested at the time, it cost money to attend these hearings and individuals simply cannot afford it.

My "Consumer Advocate" category of commentators is comprised of these 12 organizations and individuals:

• Anonymous, Individual
• Bruce Overman Jr, Individual
• Center for Digital Democracy, Consumer Advocacy Group
• Consumers Union, Consumer Advocacy Group
• Kathryn Rowerdink, Individual
• Kathy Lambert, Individual
• Melvin Flowers, Individual
• Michael E. Bailey, Individual
• National Organization for Rare Disorders, Consumer Advocacy Group
• Randall Pecsek, Individual
• Michael E. Bailey, Individual
• PEW Prescription Project, Consumer Advocacy Group

Ten (83%) of these expressed ANTI-pharma marketing sentiments such as the following:

"I think the implications of this can get out of hand. Social media and the internet allows for too much false, partially true, information which can harm the lay people who do not know the difference. It may lead to unapproved/remakes of devices that are not safe." -- Anonymous

"I and many, many others are very much against any further promotion or advertising of Food and Drug Administration-Regulated Medical Products, particularly prescription drugs. I am very much in favor of outlawing the existing practice of advertising prescription drugs. Billions of dollars are spent by pharmaceutical companies to advertise drugs, confusing and misleading the public, most of whom do not have the expertise needed to make proper judgments where these drugs are concerned. This massive amount of money should, instead, be used to reduce the cost of these drugs." -- Bruce Overman Jr

"By using an array of new digital marketing tools -- including behavioral targeting, social media, online video, and mobile -- pharmaceutical companies now have unprecedented abilities to take advantage of consumers." -- Center for Digital Democracy

"The experience with DTC ads from 1997 to the present should be a cautionary tale and compel the agency to carefully examine its options and the appropriate mechanisms to assure against widespread and unbalanced promotion of drug products via online media." - Consumers Union

"I do not want Rx drugs advertised or promoted on TV or through media to the public." -- Kathy Lambert

"This is surely helpful use the FDA regulatory authority. There need to be control on the Internet advertisements epically when it relates to medical devices and labeling." -- Melvin Flowers

"The manufacturers of medications and their representatives must be held accountable for each claim they put on any online media concerning their products because the public health and safety demands it. There maybe some online media that are not suited for drug advertising because of the space limitations involved. There may not be enough space for the important risk information that needs to come with the claims. It is too risky and dangerous to allow the drug company claims alone without the risk information. It is not enough to put in a link that you can click on to take you to another site to get the risk information because many people won't do that and will only read the claims of the drug company that it puts up on the social media. But they should always provide a link to the FDA website for people who want an unbiassed and fair assessment of the drug, and so people can report bad reactions to the drug. Thank you and best wishes, Michael E. Bailey."

"The last thing this country needs is MORE advertising by drug companies. Prescription drugs need to be administered by doctors acting in the best interest of their patients. Patients need to talk to their doctor about a medical "problem", and let the doctor determine the best treatment. Drug ads serve only to feed hypochondria in the public. Marketing of drugs and the costs of advertising serve only to drive up prescription drug costs in America. Our capitalist system is out of control, driving Americans to spent money frivolously. Let's not expand advertising opportunities, let rein them in and recind the rules which allow drug companies to advertise anywhere except medical journals intended for doctors. How many more erectile dysfunction ads do we need to be subjected to?" -- Randall Pecsek

"[W]e urge caution in promulgating rules that could effectively establish new and pervasive modes of industry marketing. It is important that current FDA guidance on the presentation of risk information not be compromised to the detriment of the public health in favor of accommodating evolving industry marketing practice. If a marketing tool, such as a space-limited microblog, or tweet, is unable to satisfy basic consumer protective measures such as the fair balance requirement, that tool should be considered inappropriate for the promotion of pharmaceutical products." -- PEW Prescription Project

"To reduce demand and help curb online diversion, we urge FDA to more stringently regulate pharmaceutical companies' advertising of controlled prescription drugs to physicians and consumers." -- The National Center on Addiction and Substance Abuse, Columbia University

The two "PRO" commentators expressed these opinions:

"Patients and patient organizations increasingly are using the social media as an important communications tool. We expect this trend to continue. Patients and families affected by rare diseases have a great need for information since they typically have a greater-than-usual participation in their own, or their loved one?s, disease management and treatment. There is opportunity for the social media to perform a helpful role in facilitating the exchange of information for rare-disease patients and families. There also is significant potential for misuse of the social media or for the circulation of inaccurate or misleading information. It is NORD?s recommendation at this time that FDA continue its deliberation of how best to provide guidance regarding manufacturers? participation in the social media, since the use of social media for sharing of medical information is widespread and growing. We understand that FDA?s resources are limited. However, it is our sense at this time that clear guidance from FDA, similar to that which is currently being provided for traditional advertising modalities, would help to define appropriate ways for manufacturers to participate in this newest of the new media. If NORD, as the primary representative of the rare disease patient community, can assist FDA with defining what the guidelines should be, we would be happy to work with FDA on that process." -- National Organization for Rare Disorders

"I believe transparency is requested for all of the healthcare industry. Prior to twitter, facebook etc. the public was posting comments on drugs (pros and cons). I have googled drugs by their marketed and generic names to read about other peoples' experiences. I had some reactions to a steroid medication I was prescribed and wanted to find others who might have experienced the same. Doing a search and finding the right forum was extremely difficult and time consuming. A drug makers facebook page or a separate page for each drug was available, it would have made life much easier. A Facebook etc with non-censored updates, stories and comments etc. would have helped me and been faster. If the drug companies and insurance companies (although this is not the topic for the FDA)agree not to censor comments and stories, this is e a great avenue for information exchange. The pros and cons of a drug are more easily assessed through other peoples experiences and comments. Regulations and laws have forced the drug industry to use very complex wording in the packaging (in good faith of full disclosure) however this not helpful to the consumer but overwhelming. I would much rather go to a social media site and view what the possible tangible experiences are so that I may weigh my options and assess the risk. If the FDA chooses to regulate social media I do not see how this is a move toward transparency. The more the FDA represses communication avenues the less people feel informed. Regulating the censoring of comments etc. should be enforced but there are too many loopholes in trying to prevent the healthcare industry from engaging in new communication avenues. The FDA should encourage communication between patients and drug makers. Not only will this help the drug companies to assess needs and fill gaps but consumers are more likely to make their voices heard and feel empowered." -- Kathryn Rowerdink

With individuals such as "Kathryn Rowerdink," it's not clear if they have a bias based on whether or not they receive funding indirectly from the drug industry (eg, are employed by an ad agency that has drug company clients).