Have You Met Turbo & Scott? FTC May Want to Meet this eBook for Children Sponsored by Novartis

Have You Met Turbo & Scott? FTC May Want to Meet this eBook for Children Sponsored by Novartis

I just found this tweet from @Novartis:

"US only: Have you met Turbo & Scott? Visit http://t.co/yJDtSvhQ to read the TSC eBook or download Barks and Crafts"

At first, I thought this would be some kind of Rx branded Web site because it was for "US only," which usually means there's some direct-to-consumer (DTC) Rx product information on the site or closely linked to it. But there isn't any hint of a drug mentioned anywhere that I can find.

It's really a site designed for young children who have TSC, "which stands for three big and hard-to-pronounce words, Tuberous Sclerosis Complex."

NOTE: Novartis probably markets the only drug approved by the FDA for treatment of TSC (see press release). Hence, even though the drug is not referenced on this site, FDA may regulate the site as if it were marketing that drug. European regulators also may feel that the TSC site violates their regulations regarding DTC communications.

The eBook is beautifully illustrated and written in the simple language that a child would use. In fact, it's a story told by Turbo, the stuffed dog friend of Scott who is "a real boy and [Turbo's] best friend." Scott has TSC.

I've never heard of TSC before, but apparently, it is a pretty serious hereditary condition that can cause seizures and may require Scott and other kids with TSC to be examined and treated by as many as SEVEN different specialists: Neurologist, Ophthalmologist, Pulmonologist, Nephrologists, Psychiatrist, Cardiologist, and Dermatologist. That's a lot of "gists!" The ebook does a good job explaining to kids what these doctors do.

But what the site does NOT do well (IMHO) is comply with the U.S. Children's Online Privacy Protection Act (COPPA). COPPA "applies to operators of commercial websites and online services directed to children under 13 that collect, use, or disclose personal information from children." Such sites may not collect personally-identifiable information from children without the consent of parents (see COPPA FAQs).

The URL in the tweet above resolves to this URL: http://www.tuberous-sclerosis.com/patient/ebook/ebookhome.jsp which displays this page:

There is a notice from Novartis at the bottom of the screen, which states "Use of this website is governed by the Terms of Use and Privacy Statement. Copyright ©2012 Novartis Pharmaceuticals Corporation. All rights reserved."

The privacy statement clearly states that "Novartis will not knowingly collect, use or disclose personally identifiable information from a minor under the age of 13, without obtaining prior consent from a person with parental responsibility (parent or guardian)." However, any child (including me) can click on the "Send to Friend" tab and enter his/her name and email address as well as the email address of a friend:

Novartis says "The email addresses you furnish will be used solely to notify the recipient of the link to this page and that you have requested it to be sent. The addresses will not be retained or reused." Since the information is not "retained of reused," this "Send to Friend" feature may be eligible for the "one-time exclusion" allowed by COPPA.

However, another feature of the site allows children to send an email message directly to TSC.Story@novartis.com.

On that page Novartis says: "TSC.Story@novartis.com is to be used to show your interest in further information. We look forward to receiving your email. The personal email information you submit will be used to deliver information about TSC and the TSC eBook program only. By submitting your information you agree to receive information via emails. Please be assured that although we share your information with third parties who work for us on these activities, neither Novartis nor third parties working on our behalf will sell or rent your personal email information. You may unsubscribe at any time by clicking here and specifying Unsubscribe in the subject of the email."

This is clearly an attempt to collect personal information from the children at whom this site is aimed.

I've sent an email to TSC.Story@novartis.com requesting more information about TSC. I signed it "Johnny Mack." So far, I haven't received any response.

P.S. There's a bit of confusion about who is responsible for collecting personal information on the site. I found this statement: "The TSC eBook is sponsored by Novartis Pharmaceuticals Corporation. With the exception of www.TSCStory.com and www.FacingTSC.com, the websites mentioned in this eBook are independently operated and not managed by Novartis, which assumes no responsibility for any information they may provide."

BI's Facebook Game Syrum to be Launched "When It's Ready." Needs to Obey Privacy & FTC Laws First!

BI's Facebook Game Syrum to be Launched "When It's Ready." Needs to Obey Privacy & FTC Laws First!

I wrote a review of Boehringer Ingelheim's (BI's) long-awaited -- but not yet available -- Facebook game, Syrum, in yesterday's post to Pharma Marketing Blog (see "Pharma & Fun, Not Oxymoronic? Here Comes Gamification!"). Today, I brought up the topic of pharma-sponsored "gamification" during the #hcsmeu chat. BI's John Pugh -- who is in charge of the Syrum project -- saw the "bat signal" that was raised when the subject of Syrum came up and he joined the conversation.

One question I asked during the chat was "@JohnPugh When is Syrum actually going to be launched? Hope not same schedule as FDA guidelines! :-)" to which John responded: "@pharmaguy Syrum will be launched when its ready, but I expect the first round of testing to be B4 the end of this year."

Oh, Oh! This sounds suspiciously like FDA's "promise" to come up with social media guidelines by the "end of the year" (ie, 2010).

So the timeline for the ACTUAL release of Syrum is sometime in 2012 (after 1st round of testing) -- maybe even ONE WHOLE YEAR after the game was announced on Facebook! Related to that, I posted this comment to the #hcsmeu chat: "Personally, I'm a little miffed at BI for promoting Syrum so far in advance of its actual launch date! All hype, no substance!"

How can BI justify announcing Syrum on Facebook (and at several industry conference presentations) a year or more before the game is actually available to be played? Hint: note the signup section at the bottom of the screen:

Of course, I signed up. I'm not sure how many other people also signed up, but is this BI's way of trial ballooning the concept? I mean, will the game be developed only if a certain number of people sign up?

John Pugh suggested that people who wish to beta test the game (me! me! pick me!) should use this form to sign up. I pointed out that the sign up form seems only for people who want to be notified when the game is launched ("Sign up below to be the first to know about the official launch or come back soon... the health of the world depends on it!").

After signing up, I received the following email message in my SPAM filter/box:

A "Syrum - Out of Office" message? Very odd! What's BI trying to do here? They are certainly not opening up to communicate with potential game players. I have NEVER received an "out-of-office" email from a pharma company! It shouts to me "We don't care very much about you." A pharma company should NEVER send an "out-of-office" reply! First of all such messages may end up ignored or, as in my case, get caught up in spam filters and never seen!

BI Ignores My Privacy Concerns and May Violate COPPA
Another point I made to John Pugh was that the Syrum site does not include a privacy policy or even a privacy statement! The "out-of-office" email message also does not include a link to a privacy statement, although there IS a link to an unsubscribe function/form.

The Syrum site also may violate US and other laws regarding Web sites that may be intended for or used by children under the age of 13 (eg, The Children's Online Privacy Protection Act (COPPA)). These laws do NOT allow collection of personally-identifiable information from children without the consent of parents. Since Syrum is a game site that John Pugh says is intended for "everyone," then it is also intended for kids.

I hope that BI will fix these problems as soon as it reads this post. Consider this my first beta test report!

Update (31 Oct 2011): I am happy to report that BI -- after reading this blog post -- has added this notice to the bottom of the Syrum Game promo screen: "Data collected form this web page will not be passed on to third parties. It will not be used for any other purpose than to contact you regarding your request or comment. All data will be deleted upon your request or as soon as they are no longer needed in order to contact you regarding your request or comment."

However, there is still the issue of collecting personally-identifiable information from children. BI needs, at least, to add a statement such as "This site is not intended for use by children under the age of 13."

Pharma Tracks Docs at Medical Meetings Using RFID Technology

Pharma Tracks Docs at Medical Meetings Using RFID Technology

Although the pharmaceutical industry is dragging its feet implementing RFID (Radio Frequency Identification) technology to keep track of drug supplies, some companies are currently using the technology to track physicians' movements at scientific conferences.

"Dr. Wes" (Westby G. Fisher, MD, FACC) called this "Physician Tag and Release" (see "The Implications of Physician Tag and Release"). The photo on the left shows the back of Dr. Wes's badge at the recent American College of Cardiology Conference held 2-5 April 2011 in New Orleans, LA.

The technology is also being used at the Heart Rhythm Society conference going on right now. Propublica and USA Today co-published a story about how doctors are being bombarded with pitches for drugs and medical devices at this conference (see "Financial Ties Bind Medical Societies To Drug and Device Makers").

RFID tracking is a disturbing aspect of industry-sponsorship because it may give exhibitors access to the identity of any physician who enters (or merely passes by?) sponsor booths at medical meetings even if the docs do not talk to reps or give their permission to collect such information.

"Many physicians were unaware that exhibitors had paid to receive real-time data about who visited their booths, including names, job titles and how much time they spent," says Propublica.

The Heart Rhythm Society claims that exhibitors are not getting doctors’ personal information, but here's what the American College of Cardiology says about how its exhibitors benefit from RFID technology (see "Using Technology to Better Understand ACC Meeting Attendees"):

"The second way in which RFID technology is utilized is in the Exposition. Exhibitors were able to rent RFID readers from the vendor. They are able to use the data in much the same way as the ACC – to evaluate how effectively their work stations are structured and to improve their offerings to attendees. In addition, they are given access to limited information about the visitors to their booths. The information they are given is the same information that was available on meeting attendees badges in print (name/city/state/institution). No contact information is provided. ACC’s intention was not to create a revenue source by offering attendee data to exhibitors (in fact, only five out of more than 300 exhibiting companies decided to invest in RFID in their booths), but rather to provide exhibitors another resource by which to understand the traffic flow in their booths and to better align their displays with attendees’ needs."

Instead of "opting in" for tracking at scientific meetings, doctors must "opt out" from the use of tracking technology when registering for scientific meetings.

The practice "disturbs" Dr. Wes who says:

"It is no secret that these societies make a significant portion of their operating revenues from industry sponsors at these meetings. By instituting tracking, the value of their membership's privacy has taken a back seat to the income generated from tracking revenues."

and

"At the risk of sounding like a conspiracy theorist, it is not too hard to imagine one's credentials being called into question in court because a doctor did not demonstrate enough time in CME activities at the scientific sessions to quality for credit or because these data implicate a doctor in a purchasing agreement between a vendor and hospital system simply because a doctor visited a display booth."

Dr. Wes also imagines a scenario where RFID data collected at medical meetings can be combined with a doctor's prescribing information without their permission. That's a double whammy for physicians who wish to keep their prescribing habits private. The Supreme Court is deliberating that issue (see "Supreme Court to Decide Fate of State Laws that Prohibit Use of Rx Records by Pharma").

New Media, New Ways to Track You. Online Ad Technology is One Step Ahead of Lawmakers and Regulators

New Media, New Ways to Track You. Online Ad Technology is One Step Ahead of Lawmakers and Regulators

Citing privacy concerns, the Energy and Commerce Subcommittee on Commerce, Trade and Consumer Protection will hold a hearing tomorrow (December 2, 2010) on the feasibility of establishing a "Do Not Track" registry for the Internet.

Today, the Federal Trade Commission (FTC) will release its much-anticipated privacy report calling for a "do-not-track" tool for Web browsers (see "New Media Privacy Issues & Online Health Marketing" media advisory).

Also today, privacy wonks are meeting in Washington, DC at the National Press Club conference "The Future of Online Consumer Protections." Topics for discussion include:

• Protecting consumers while they surf the web: How to make a "Do Not Track Me" list work and other ideas.
• How costs can be cut with electronic medical records while still maintaining patient privacy.
• Is online health and drug marketing deceptive? Does it invade consumers' privacy?

One of the people presenting at that meeting is Jeff Chester, Founder and Executive Director of the Center for Digital Democracy (CDD). CDD and other privacy groups recently submitted a brief to the FTC citing "unfair and deceptive" online health and drug advertising practices (see, for example, "Center for Digital Democracy Challenges FTC to Reign In Online Pharma Marketing" and here).

Chester will be a guest on my Pharma Marketing Talk BlogTalkRadio show next Thursday and I'm currently hosting a survey on the issues (see below).

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New Media Tracking Technologies: Implications for Online Consumer Privacy
A conversation with Jeff Chester, Founder and Executive Director of the Center for Digital Democracy, about his organization's recently filed brief with the FTC requesting an "Investigation, Public Disclosure, Injunction, and Other Relief" regarding the array of sophisticated and non-transparent interactive marketing applications utilized by healthcare companies and the pharmaceutical industry to promote drugs online.

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While lawmakers and regulators are focused on "do not track" laws and web browser fixes, online advertising technology is already being "unleashed" that will make such laws, regulations, and fixes obsolete before the ink is dry. That's because these laws all focus on Web tracking cookies, which according to BlueCava CEO David Norris, "are a joke."

BlueCava and other companies are developing "digital fingerprint technology to identify how we use our computers, mobile devices and TV set-top boxes," according to this Wall Street Journal article. Here are some excerpts:

Device fingerprinting is a powerful emerging tool in this trade. It's "the next generation of online advertising," Mr. Norris says.

It might seem that one computer is pretty much like any other. Far from it: Each has a different clock setting, different fonts, different software and many other characteristics that make it unique. Every time a typical computer goes online, it broadcasts hundreds of such details as a calling card to other computers it communicates with. Tracking companies can use this data to uniquely identify computers, cellphones and other devices, and then build profiles of the people who use them.

Tracking companies are now embracing fingerprinting partly because it is much tougher to block than other common tools used to monitor people online, such as browser "cookies," tiny text files on a computer that can be deleted.

It's tough even for sophisticated Web surfers to tell if their gear is being fingerprinted. Even if people modify their machines—adding or deleting fonts, or updating software—fingerprinters often can still recognize them. There's not yet a way for people to delete fingerprints that have been collected. In short, fingerprinting is largely invisible, tough to fend off and semi-permanent.

Blue Cava also is seeking to use a controversial technique of matching online data about people with catalogs of offline information about them, such as property records, motor-vehicle registrations, income estimates and other details. It works like this: An individual logs into a website using a name or e-mail address.

The website shares those details with an offline-data company, which uses the email address or name to look up its files about the person.

The data company then strips out the user's name and passes BlueCava information from offline databases. BlueCava then adds those personal details to its profile of that device.

As a result, BlueCava expects to have extremely detailed profiles of devices that could be more useful to marketers. In its privacy policy, BlueCava says it plans to hang onto device data "for the foreseeable future."

Pretty scary, huh?

Is Your Digital Marketing Solution Mentioned in the CDD Brief? It Should Be!

Is Your Digital Marketing Solution Mentioned in the CDD Brief? It Should Be!

After a day of cooking, I spent the remainder of the Thanksgiving Holiday weekend reading and highlighting sections of the 144-page brief that the Center for Digital Democracy (CDD) filed with the FTC on Thanksgiving eve (see "Center for Digital Democracy Challenges FTC to Reign In Online Pharma Marketing").

This document -- now in the public domain (find it here) -- is perhaps one of the BEST reviews of healthcare-related digital marketing techniques that I have ever seen! I recommend that ALL pharma marketers read it to learn which companies to contact to help them do a better job reaching online consumers and physicians.

There were several companies and products mentioned that I have not heard of. In that regard, this brief -- negative though it may be -- is a promotional boon for these companies, IMHO. You can't buy this kind of publicity and as a recent article in the New York Times proves, even negative publicity can help you get top listing in Google searches (see "A Bully Finds a Pulpit on the Web").

I compiled a list of more than two dozen innovative online marketing products/solutions mentioned in the CDD brief. My list includes the product name, company/site name, description, link to online information, and the paragraph number in the brief where you can find what the CDD has to say about it (download the list here).

If your company is NOT listed, I suggest that you (1) contact CDD and ask them to amend their brief to include your solution and/or (2) file your own brief with the FTC.

Of course, CDD does not view these solutions as "innovative." In fact the CDD thinks they are "unfair and deceptive":

"The companies named in this complaint, as well as others involved in real-time tracking and bidding -- including those that provide data optimization services for profiled targeting -- are engaged in unfair and deceptive practices."

I must admit that one or two of the services were a bit scary. QualityHealth's "Focus on Formulary" solution, for example, claims to be "sophisticated technology" that "links consumer marketing with brand formulary access." It designs "targeting messaging directly to millions of profiled consumers based on prescription coverage." CDD says: "Few consumers likely realize, however, that they have consented to become the subjects of a 'proprietary profiling technology' that “captures… valuable information across over 100 individual data points,” including 'consumers’ conditions and preferred treatments'; 'doctor relationships and plans to visit the doctor'; and 'insurance and formulary coverage.'"

ConditionMatch (offered by Good Health Media) claims to use “cutting edge behavioral targeting technology…[and] identifies groups with common sets of conditions/health-related characteristics by geographic region via insurance claims and individual ‘opt-in’ data.”

Both sound like they may have HIPAA privacy issues.

There is no lack of innovation regarding the names given to some of these solutions, such as:

• ActuatoRx Geo-Medical Targeting
• Acquire2Convert
• Healthographics
• Pluck
• Intent Targeting Advertising
• Target 2 Measure
• BuzzScape
• Social Operating System
• Bizo Targeting Platform
• Quantemo Engagement Index
• Subconscious Resonance Testing
• Evoked Response Potential

The CDD does not analyze whether or not the claims made by the companies it cites are credible or designed to hookwink gullible pharma marketers into purchasing their solutions. For example, are there any pharma marketers who are convinced that "Pluck," which is designed to engage consumers in conversations with brands, is a viable solution for Rx products?

Which leads me to wonder why the CDD focused exclusively on healthcare marketing as a target for its critique. Many of the marketing tactics cited by CDD probably were first developed for the consumer goods industry and then renamed/rebranded to appeal to healthcare marketers as well. The CDD has helped accelerate the process!

Center for Digital Democracy Challenges FTC to Reign In Online Pharma Marketing

Center for Digital Democracy Challenges FTC to Reign In Online Pharma Marketing

Today, the Center for Digital Democracy filed a 144-page brief with the FTC challenging that agency to investigate its charges that Google, Microsoft, QualityHealth, WebMD, Yahoo, AOL, HealthCentral, Healthline, Everyday Health, and other health marketers -- including major pharmaceutical companies -- have "unleashed an arsenal of techniques to track and profile consumers" in an unfair and deceptive manner.

In the brief, which you can download here (huge pdf file), the CDD urges the FTC to "immediately conduct a thorough investigation and analysis of contemporary Digital Direct Marketing to Consumers of drug and health-related products and information. In addition to seeking the appropriate injunctions and other relief, we also urge the FTC to issue a report and recommendations designed to inform consumers and health professionals of the issues raised by interactive ads for medical products and services."

CDD has a long list of specific requests that can be found on the last few pages of the brief. I'll list a few of the more juicy ones here.

CDD says FTC should

• "Examine and analyze the data collection and usage practices of pharmaceutical advertisers to assess the extent of consumer information collected through websites, social networks, online video sites, and other interactive means. This should include personal information, IP addresses, cookies, flash cookies, Web bugs, tracking pixels, Web analytic tools, conversational and sentiment analysis [my emphasis], and any other 'data-mining' applications. We urge the FTC to resist suggestions that such data collection methods are appropriate because they can help identify risk-averse-related information."
• "Analyze how health-related social media marketing influences consumer behavior and attitudes on drug use and about medical conditions. The agency should examine social media marketing applications for the health market designed to foster 'viral' marketing approaches, including the targeting of specific consumers in order to influence their own network of relationships."
• "Investigate whether there is a violation of the FTC’s Endorsement guidelines (which the FTC has extended to the Internet) when advice is given to patients or consumers from seemingly independent health bloggers who do not disclose that they are paid or sponsored by pharmaceutical or other companies."
• "Obtain from pharmaceutical companies a list of the keywords used for paid search campaigns. The companies should also be required to inform the FTC of the techniques and applications they may use in so-called organic search to show up prominently in the results. U.S. consumers should be informed by the FTC of the implications of search marketing practices when they are looking for information and advice.
• "Work with the Food and Drug Administration and other appropriate agencies to develop a set of policies for regulating the use of behavioral targeting, data collection, and other digital techniques in the marketing of drugs and health-related products."

I have the "honor" of being quoted in paragraph 119.

Pre-Emptive Medication Adherence. Is Pre-Emptive DTC Next?

Pre-Emptive Medication Adherence. Is Pre-Emptive DTC Next?

Computers are intruding into our lives more and more these days. I'm not talking necessarily about the Internet, but about automated programs that different industries use to do things like initiate stock market trades without human intervention, which is a story I saw last night on 60 Minutes. It's reputed that one such trade sent the market in a momentary tailspin that could have lead to a monetary crisis. According experts, such automated trades are undermining the general public's trust in the stock market. I for one have taken a lot of my retirement money out of stocks.

Today I read about how Express Scripts, a pharmacy benefit management (PBM) company, is now able to accurately predict up to a year in advance which patients are most at risk of falling off their physician-prescribed drug therapy -- and to intervene in customized ways to improve those patients' adherence. To do this, Express Scripts uses "a set of proprietary computer models" that analyzes personal data of patients in its database. The data includes such things as prescription history, whether the patient has kids living at home, etc.

"Previous industry attempts to predict therapy adherence were hampered by both the types and quantity of data available," said David Tomala, director of advanced analytics at Express Scripts. "Our tens of millions of members, hundreds of millions of annual prescriptions, and advanced understanding of human behavior were key to 'cracking the code' on therapy adherence. We are now the first pharmacy benefit manager to be able to -- with high fidelity -- discriminate in advance and intervene in an effective manner. This approach addresses adherence problems among those patients who need our help the most. Improved adherence is the hallmark of better quality care, healthier patients, and reduced overall medical costs" (see press release).

Of course, it is nothing new for PBMs to mine their patient data and find those patients who have not filled prescriptions.  According to the Wall Street Journal, "the new efforts are broader, and can focus on apparently healthy people. They use models developed from enormous troves of medical and other data. These are then applied to each patient's own claims information."

PBMs often get paid by pharmaceutical companies to identify patients who are not refilling their prescriptions and to send them prescription refill reminders by mail or call them. Increasing adherence can greatly help pharmaceutical bottom lines and PBMs also benefit when more prescriptions are filled. Conventional wisdom -- and maybe even some research data -- suggests that patients will also benefit.

But computer models often result in unintended consequences as evidenced by automated stock market trades. What could be the equivalent breakdown in the health market? Obviously, there's the privacy issue: "Ethics researchers say such efforts can raise privacy and other concerns if people don't deliberately grant permission for such use of their data, as well as potentially usurp the role of doctors, who know patients best," notes the Wall Street Journal.

"It undermines the trust an individual has in their physician," said Mark A. Rothstein, a bioethics professor at the University of Louisville," who was quoted in the WSJ article.

It could also undermine the trust in the pharmaceutical industry, I suppose.

One further thought. If these computer programs can identify future health problems in otherwise healthy people, will there be pre-emptive pharma-sponsored notices sent out to patients advising them to see their doctors? As consumers provide more and more private information to pharmaceutical companies, I can even imagine pre-emptive direct-to-consumer advertising!