"Novartis Land" the Latest Entry in Weird Drug-Based Video Game Trend

by Jim Edwards
originally posted 3/23/09 (original post: http://bit.ly/4rYrvj)

Teva might want to ask Novartis where the latter got its idea for “Novartis Land,” the HR video game that Novartis employees are asked to play in order to teach them about ethics. Novartis Land bears a strong resemblance to Teva’s game, “Biologicsland.”

BNET readers will remember that back in October Teva launched Biologicsland as an online game that gently hints there ought to be a legal pathway to generic biologic drugs. (And yes, that game was as dull as it sounds!)

The games are just the latest in the pharmaceutical industry’s baffling obsession with trying to present drug information via thrilling interactive gameplay. Pfizer, Sanofi and Novo Nordisk have all trodden in the Valley of the Joystick (see below for more examples).

Here’s how Novartis Land works, according to this press release from the Ethical Corporation Institute:

Employees at Novartis don’t just sit in training workshops. They ‘play’ there way to learning about the company’s code of ethics in “Novartis Land”, an online training program offering the opportunity to interactively explore the policies and answer questions in an online dialogue-role-play setting.

Employees interact online with 3D characters and have dialogues based on scenarios found within the company’s corporate policies. They navigate through the dialogue, making decisions they may have to make in real life and answer a quiz style game show on company ethics. Once all available dialogues and game shows are successfully completed, a company certificate is issued.

Of course, both Teva and Novartis ought to be sued for IP violations by Hasbro, which owns Candy Land, the game that all this stems from.

Manhattan Research Releases Digital DTC Relevance Rankings

Manhattan Research Releases Digital DTC Relevance Rankings, Revealing Which Condition Groups Are Most Likely to Adopt eHealth

Acne, Restless Leg Syndrome, and Cancer Patients are Among the Top Condition Groups Shaping the Future of Digital DTC Marketing

New York, April 8, 2009 - More than 60% of U.S. adults turn to the Internet as a decision support tool in healthcare and disease management, and certain condition groups are more likely to use online health resources than others, according to pharmaceutical and healthcare market research company Manhattan Research.

Acne, restless leg syndrome, and cancer patients are among the top ten therapeutic categories adopting eHealth activities, which can range from reading a health-related blog to joining an online patient community. The increasing use of consumer reliance on the Internet for health and pharmaceutical information is transforming digital direct-to-consumer (DTC) marketing from a "nice to have" tactic to an essential communication channel for pharma companies reaching consumer audiences.

Manhattan Research releases its Digital DTC Relevance Rankings, revealing which condition groups are most likely to use the Internet for health information out of a pool of over 100 therapeutic categories. The findings come from Cybercitizen Health(tm) v8.0, the company's consumer market research and advisory service. The Digital DTC Relevance chart shows that for some brands, such as those targeting acne, adult ADHD, and fibromyalgia patients, it's especially critical to take note of digital opportunities in shaping future DTC marketing strategies.

Digital DTC Relevance Rankings Top Condition Groups Online for Health Ranked by number of U.S. adults Position Condition

1. Acne
2. Adult ADHD (Attention Deficit Hyperactivity Disorder)
3. Fibromyalgia
4. Migraine
5. Allergies
6. Irritable Bowel Syndrome
7. Anxiety Disorder/Social Phobia
8. Asthma
9. Restless Leg Syndrome
10. Cancer

Among U.S. adults (18+) Source: Cybercitizen Health(tm) v8.0 (2008)

"This is the year in which pharmaceutical companies must stop merely 'talking at' consumers and begin communicating with them. The old way of DTC marketing isn't going to cut it as the consumer media landscape evolves," said Meredith Abreu Ressi, Vice President of Research at Manhattan Research. "Though we've shared just a few of the top condition groups online for health, the reality is that all pharmaceutical marketers are finding that their target audiences are shifting from traditional offline sources to the Internet for their everyday needs, including health management."

Manhattan Research at the DTC National Conference

Manhattan Research Vice President of Research Meredith Abreu Ressi will be presenting "How New Media Changes Pharmaceutical DTC Advertising" with Jeff Hitchcock, President and Founder of Children with Diabetes, a Johnson and Johnson Company, at the DTC National Conference on Thursday, April 16, 2009 in Washington D.C.

Internet Searching May Get ‘Riskier’ For Patients After FDA Citations

by Carlene Olsen ( http://bit.ly/8WCD)

Article reprinted from "The Pink Sheet" DAILY April 7, 2009

Company-sponsored search results that appear on Internet search engines should not contain therapeutic claims if they also contain drug names, FDA suggests in a cluster of letters to 14 firms citing 48 products.

Sponsored search results - the links that appear on the top of a search return and include a promotional message - have become increasingly common as firms try to communicate with patients looking for health information online.

But the technology that allows patients to target their searches and sponsors to tailor their messages creates a host of problems when it comes to defining what the standards for advertising in the new medium should be. FDA has so far declined to issue Internet-specific guidance, saying it will use the print and TV standards as appropriate. Similarly, the Pharmaceutical Research and Manufacturers of America did not mention the Internet in the recent update of its principles for direct-to-consumer advertising.

In this case, the sponsored links are probably best interpreted as very short text advertisements, with FDA saying that if they contain the name of the drug and a therapeutic claim, they must also include risk information.

Which Standards Apply?

Typical among the cited links is a blurb for Sanofi-Aventis's Plavix "PLAVIX Medication Lowers Risks of Future Heart Attack or Stroke from PAD See how prescription PLAVIX medication may help patients with recent heart attack, recent stroke, or established P.A.D. at PADfacts.com." FDA says that in addition to lacking risk information, the link should have mentioned the product's generic name (clopidogrel).

Most of the firms that FDA cited in the round up, including Sanofi, say they were following what they thought was the standard for risk disclosure - providing it on the click through, akin to turning the page in a magazine. The agency, though, seems to interpret the sponsored links more like a bombastic sales aid with labeling attached: making the full information eventually available is not enough to overcome the misimpression created initially.

The citations will likely result in substantial rewriting of the search-result messages. One solution for firms would be to insert a "fanciful" name in place of a product name in a search engine link that leads to a company-sponsored product Web site, offered Ropes & Gray partner Alan Bennett.

"Anytime a drug name appears in conjunction with a claim, FDA appears to be taking a position that firms need to include all the product risk information ... the easy fix is to eliminate the drug name," Bennett said.

The combination of increasing Internet use and lack of clear regulatory standards was destined to produce violations, and while FDA has cited many Internet advertisements over the years, the sheer volume of the most recent batch of letter seems intended to convey the urgency of the agency's concerns about sponsored links.

"While conducting our routine monitoring and surveillance activities, we noticed regulatory violations occurring in sponsored link promotion across multiple drug companies and therapeutic areas; in response, we developed and issued multiple letters on multiple drugs simultaneously to prompt the correction of the violations we were seeing in these links and to maintain a level playing field for regulated industry," FDA said in a statement.

The agency released another thematic grouping of letters last fall citing attention deficit hyperactivity disorder products.

[Editor's note: Windhover is sponsoring a webinar on "How to Navigate Changing Trends in DTC Advertising." The May 20 event features Oregon Assistant Attorney General David Hart and McDermott, Will & Emery Counsel Arnold Friede. To register, visit http://www.windhover.com/ezine/html/ac0509-LP.htm, call 800-332-2181, or email fdcwindhover.custcare@elsevier.com.]

Risk Management Creates Fewer Promotional Restrictions?

Among products cited in the spate of letters was Biogen Idec's multiple sclerosis and Crohn's disease drug Tysabri (natalizumab), which was pulled from the market because of a rare brain infection risk and returned with a tightly-restricted risk management program.

FDA's letter noted some of the sponsored links included the tag line "Satisfied with your MS Medication or Looking for Something Different?"

"Their casual approach to Tysabri treatment is extraordinary in light of the potentially lethal risks of the drug and the stringent controls over its distribution," the letter states.

Biogen appears to see the meaning of its risk management program differently. Although it is working with FDA to resolve the its concerns regarding the links, the firm pointed out that all patients receive the full risk information for Tysabri in mandatory talks with physicians, regardless of Internet searches.

"Unlike the other products flagged, Tysabri has a disciplined risk management program in place and no patient in the U.S. can gain access to the drug without formal enrollment in the REMS TOUCH program, so the risks are all clearly explained by the physician before prescribing," the firm said.

The C-list: FDA's citations

The companies cited in FDA's sweep involve nearly all the prominent drug firms. Pfizer, GlaxoSmithKline and Genentech received the largest number of FDA citations - six each - for volatile search links.

Pfizer's include: Aromasin (exemestane); Caduey (amlodipine besylate/atorvastatin calcium); Chantix (varenicline); Detrol LA (tolterodine); Lyrica (pregabalin); and Celebrex (celecoxib).

GlaxoSmithKline's include: Avandia (rosiglitazone) ; Avandamet (rosiglitazone/metformin) ; Avandaryl (rosiglitazone/glimepiride) Tablets; Avodart (dutasteride); Coreg CR (carvedilol); and Tykerb (lapatinib).

Genentech's include: Avastin (bevacizumab); Lucentis (ranibizumab injection); Rituxan (rituximab); Xolair (omalizumab); Herceptin (trastuzumab); and Pulmozyme (dornase).

Novartis received five citations including: Femara (letrozole); Diovan (valsartan) tablets; Exforge (amlodipine/valsartan); Exjade (deferasirox); and Gleevec (imatinib).

Forest Laboratories received four citations for Bystolic (nebivolol); Campral (acamprosate); Lexapro (escitalopram); and Namenda (memantine).

Merck also received four citations for: Januvia (sitagliptin); Propecia (finasteride); Singulair (montelukast); and Emend (aprepitant).

Firms with three citations include: Bayer for Levitra (vardenafil); Yaz (drospirenone/ ethinyl estradiol) and Mirena (levonorgestrel-releasing intrauterine system); Hoffma-LaRoche for Boniva (ibandronate); Pegasys (peginterferon alfa-2a); and Xeloda (capecitabine); and Boehringer Ingelheim for Spiriva HandiHaler (tiotropium); Flomax (tamsulosin hydrochloride); and Mirapex (pramipexole). As well as Lilly for Cymbalta (duloxetine); Evista (raloxifene); and Gemzar (gemcitabine).

Firms with two or fewer citations include: Cephalon for Fentora (fentanyl) and Treanda (bendamustine); Biogen Idec for Tysabri (natalizumab); Sanofi-Aventis for Plavix (clopidogrel); Johnson & Johnson for Prezista (darunavir).

FDA Pounces on Digital Advertising

posted by Emily Downward on Apr 7, 2009
original post: http://bit.ly/k5fS

Last week, the FDA issued 14 warning letters about digital advertising, specifically paid keyword advertising. Paid keyword advertising is the text ads that come up in search results, usually on the top or right-hand side, marked “Sponsored Links.” Marketers generally buy their brand names, indications and symptoms of the condition.

All the warnings were consistent with one of the DDMAC rules for pharma marketing: if you make a claim, even if it’s just the brand name and the indication, you must include fair balance. The companies receiving the warning letters last week were running text ads for their products without providing risk information. Granted, there isn’t space allowable within search advertising to include the fair balance. So that means brands can either create a reminder ad or drive traffic to different site, such as a corporate or unbranded site.

However, there is still a lot of gray area: for example, can you buy the keyword for the condition ("breast cancer") and run a reminder ad for your brand that treats it? Maybe some will try this, but others may decide against it. This is another example of how much guidelines from the FDA are needed, rather than trying to infer what’s acceptable and what’s not from the warning letters they issue.

Frankly, the FDA probably could have issued more than 14 letters, as this usage of branded paid search advertising is fairly widespread and has been for years. Why did pharma marketers think this was okay? In the absence of any guidelines for the digital space, marketers had made the assumption that having the risk information “one click away” was sufficient. The “one click rule” has been a generally understood practice for at least 9 years across online marketing, including many product Web sites. With these latest letters, we now know that’s not acceptable to the FDA. How many brands will need to change their Web sites and other online marketing assets to reflect this new understanding? And while these letters were targeting a practice that’s very “Web 1.0,” this will likely have impact into the social media space of Web 2.0 as well.

These letters will change keyword advertising for pharma. I would predict that brands will use an unbranded property or their corporate sites for most of the disease-state and symptom keyword buys, and they may decide not to buy their brand name at all. The brand site should rank first in organic listings anyway, so there is a question of whether buying the brand name as a keyword buy is an efficient spend of limited dollars. It will also place more importance on search engine optimization of sites, using keyword density, titles, and inbound links so the site ranks highly in organic search engine results.

But it also leaves a gaping hole in branded keyword advertising. Keyword advertising isn’t just used for marketing, they are used for communications, reputation management, and to counter incorrect/false listings. Pulling the pharma companies out of this space leaves the door open to offshore pharmacies, class action lawyers, and alternative therapies. It also reduces the keyword cost, so they’ll be able to buy more visibility.

FDA to Search Engines: You Lose!

By Brian Orelli (http://bit.ly/ddZq)

The Food and Drug Administration brought out the paddywagon last week, issuing 14 warning letters all circling around the same theme: It's still an ad, even if you have to click on it.

The agency requires direct-to-consumer advertisements to include side effect information if they indicate what the drug is used for. But "sponsored links" that you get in the results of an internet search for a disease or drug name don't contain warning information, and the FDA wants the drugmakers to stop making claims in those advertisements.

Pretty much all the major drugmakers -- Johnson & Johnson (NYSE: JNJ), Eli Lilly, and Merck (NYSE: MRK) just to name a few -- got letters covering a whopping 48 different drugs. Warning letters generally aren't a major issue; they're kind of like parents asking their kids to clean up their room: Fix the problem, and there's no major harm done.

Avoiding "sponsored links" will change the way drugmakers advertise, but I'm not convinced it'll be a major problem for sales. I imagine that most of the advertisements were effective for increasing brand recognition -- or convincing patients to switch from, say, Pfizer's (NYSE: PFE) Rebif to Biogen Idec (Nasdaq: BIIB) and Elan's Tysabri -- rather than convincing patients to start treating a medical issue that they wouldn't have treated without the advertisements. It's one less tool in the arsenal, but all the companies are on a level playing field, and cumulative sales shouldn't be hurt that much.

The bigger losers in the FDA crackdown are Google (Nasdaq: GOOG), Yahoo! (Nasdaq: YHOO), and Microsoft (Nasdaq: MSFT). These companies' search engines have had a hard time wooing drug companies to the internet, and this rule clarification just made that task more difficult. There are ways around the rules -- advertisements for non-branded consumer-information websites, for instance -- but the search engines are likely to take a hit because of the agency's cleanout.

One has to wonder why the FDA picked now to issue the warnings, since the drugmakers have been advertising like this for quite a while. If the new administration has decided to be generally tougher on pharmaceutical companies, that's certainly bad news for the industry, and a trend worth watching for investors.

Big Government Goes After Pharma Marketers

Two major pieces of news came to light over the past week that will likely have far-reaching implications for the way pharmaceutical companies market online.

Read Wendy Blackburn’s complete blog posting: http://bit.ly/f3HDH

Digital Marketing Conference Barcelona - Socially Challenged Pharma

Source: Med 2.0
Original post: http://bit.ly/ixC9a

We all know Social Marketing is the Next Big Thing. Or at least, that’s what we are all saying to each other. Making each other believe that the era of the 4/5/6 P’s is finally over. And of course Big Pharma can not stay behind forever. In a relatively short period the content of pharma congresses has changed dramatically. Two years ago a typical pharma marketing congress dealt with eDetailing, brand management and CRM systems. Now it’s about communities, Twitter, authenticity and transparency. Finally.

It was the first attempt for EXL Pharma to enter the ‘Old World’ with their Digital Pharma congress. Already an established event in the States, they now found the time right to see whether the Europeans are like-minded in the exciting area of new/social/digital media in pharma. And it seems that they are not the only one, by the way. This year alone we have been contacted by two other congress organizations which are planning to enter this space as well. It’s an interesting area to be in right now, especially when you have a story to tell.

We just returned from Barcelona (raining for two days, bummer!) and we look back to -in our view- a succesful first event organized by EXL. Of course not all things were perfect, it usually isn’t - especially when you do it for the first time. But I have to admit that Jason Youner and Bryan Main did a good job in pulling this thing off. Kudos go to them.

Now, let’s dive a bit into the program. I won’t cover all presentations, only the ones which were truly remarkable for me. For the Twitter feed with all tweets during the conference I refer to the EXL website with the Cover It Live feed (or search Twitter with #digitalpharma)

Old skool
EXL’s Digital Pharma Europe was organized in Barcelona on March 30 and 31. See for the full program here. The morning of the first day was reserved for a workshop entitled ‘Successfully integrating Digital Media into the Overall Marketing Mix’. Sam Trujillo, Director of Marketing Women’s Health explained in a three hour session the view of Bayer Schering on the way to engage with digital media in the marketing mix. Apart from the fact that a workshop usually involves ‘working’ and we didn’t do more than just listening, I did not find his story appealing and at it’s place at this event. His story was mainly focussing on digital media (fair enough) but it looked like the process he was presenting very much described the traditional approach of pharma companies using media: to stay in control. Seriously, I just do not think that putting your commercials on YouTube will generate a lot of traffic towards your channels. Who on earth is going to watch voluntarely a commercial of a pharma company, including the usual fair balance BS? It’s just not the channel for that.

The rest of the day was reserved for more Social Media stuff. So did Jeff Hithcock from ‘Children With Diabetes‘ (CWD) a touching presentation on his social network for parents and children with diabetes. Once started as a virtual space he created for his daughter suffering from diabetes, now a huge online community for thousands of diabetes children. Recently J&J acquired CWD. It’s not clear to me however what’s in it for J&J.

Pharma going social
Another great presentation was from Heidi Youngkin, Executive Director Global Marketing at J&J. She held an informative and engaging talk on her ‘Social Media Adventures’ within J&J. Intruiging to see that a pharma company is already that advanced. No doubt the fact that J&J is a huge company with a lot of FMCG might help, but still. I’m sure that her guidelines will be used as a ‘golden standard’ and reference frame within more pharma companies (I saw a lot of people making notes, since her presentation was not available online). Interestingly J&J started slowly with a blog about the history of the company (nice and safe). After they gained sufficient experience with this new medium they introduced a blog more specifically targeted towards their end users and dealing with more complex subjects. Now they have entered the third stage, going beyond blogs such as participating in the beforementioned community CWD. During the rest of the conference J&J was quoted and cited as ‘Best Practices’ on several occassions.

The first day finished by a lively panel discussion moderated by Len Starnes, Head of Digital Marketing & Sales General Medicine at Bayer Schering. The panel discussion covered the paradigm shift of web 2.0 in the pharma world. Or should we say how pharma lives in the past not using (some of) these technologies. Interestingly it turned out that the FDA was present as well. Silently sitting in the back of the room, observing how Big Pharma is struggling with this paradigm shift. It sure is a pitty they (or anybody else for that matter) didn’t take the opportunity to start the conversation. And where were the European authorities?

Doctors and communities
Len must have done a great deal with EXL because the next day he kicked-off the second day of the event with his presentation entitled ‘Healthcare Professionals’ Social Networks - The Beginning of the End of Pharma Marketing As We Know It’. We’ve met Len at several other congresses and it’s always good to listen to his vision on digital marketing within Big Pharma. This time he gave a sound overview of all possible social networks available for the HCP (Health Care Professional). Although a few big players (Sermo and MedScape) there is still room for niche players like Ozmosis for example. And what about Europe? Well, it seems that Doctors.net.uk and DocCheck Faces are the biggest players on our continent but they will soon face competition by the Powerhouse Sermo which intends to introduce here in the not so distant future. Main question of course is how Big Pharma can participate in these communities. Sermo has a partnership with Pfizer, so is this the way to go? Len was firm in his statement that the pharma industry should observe, research, engage and discuss, but under no circumstances should hard sell. He also did a small poll on LinkedIn which showed that 86% of his network believes that Social Networks will have an impact on pharma marketing within the near future.

Enterprise 2.0 and innovation in Pharma
My presentation was next, talking about the internal use of Social Media in the light of innovation in marketing services. I am always surprised to see that an entire industry just jumps on the bandwagon of using social media for external use and just forgets that they first have to deal with yet another -equally important- community: their employees. Why is it that I can’t find more about my colleagues in Outlook’s address book other than their name, telephone number and office number whereas when I check on Facebook and LinkedIn I can find half of their life? Why is it that even a New Media Specialist is blocked access to YouTube at the office because she ‘might watch YouTube videos all day long’? Get seriouss, executives. Wake up in a new world and embrace yourself for the entrance of the digital natives, people who are actually used to share information with each other (and are hence not afraid to lose their ‘power’ when they do). Or read this for a change. We want to create a common platform within our organization where employees can find our internal blog, wikis, podcasts and share ideas. And if that means that we have to pull-in some people screamin’ and kickin’, so it is. Change is never without some pain.

YouTube genius
Yet another great presentation was from Kevin Nalty, Marketing Director Dermatology at a large pharma company which name could not be revealed but starts with an ‘M’ and ends with ‘erck’. Besides his serious job he moonlights as an official YouTube Comedian. His website Willvideoforfood is described as ‘a blog for online video, advertising, viral marketing, consumer generated media and blatant self-promotion’. Don’t know if he really needs a site doing all this since he’s one of the top-10 most viewed YouTube comedians with more than 750 videos seen in excess of 60 million times. He even wrote an e-book ‘How To Become Popular On YouTube Without Any Talent’. Well, I don’t have to explain you that we 100% agree with his vision about the power of video in communication. What we do differ in opinion is that although content is still king, form is becoming more and more important. By that I mean that the basic elements of filming should be carried out well (e.g. sound, lightning, basic rules of camera movement). That doesn’t mean that I think one should make a slick commercial. Please don’t. Some ‘rough edges’ gives it most of the time a bit more genuine look. But I will skip videos where the sound quality is poor, even if they have a nice story to tell.

Now, online video is exploding: Pharma, wake up and start using it!

The last presentation was an overview of the possibilities Google has to offer big Pharma. Interesting in that respect is Google.org, a CSR initiative of Google helping the community with their innovative concepts.

A quick wrap up ended the Digital Pharma Congress in Barcelona. Main take home messages of the audience (well, from people who actually dared to shout it out loud):

That last point was not put in by me, but most probably due to me…

The future
I think it was a good start for such an event. I hope that for next congresses dealing with this subjects participation of European authorities is paramount since they are the gatekeepers of communication possibilities within our industry. Compared to the US Europe is different in that respect, also because we (still) have many different local authorities which can play and are playing according to their rules. The market is changing, people are getting more informed. The question is which information they use in order to get informed, and to what respect the quality of information is improved if Pharma can participate in the discussion. Pharma on the other hand should take it’s responsibility too, by being open and transparent about their products and claims. Pharma is low on the trust-scale, time to open up and fix that. Looking to the people in the audience I have the feeling that Pharma is ready for it. Now authorities, give them the opportunity to do so.

Stay tuned, soon I will post my presentation including the video online.

Pharma Reps' Worst Fear Is Near: Outsourced to the Internet!

source: Pharma Marketing Blog (John Mack)
Link to original post: http://bit.ly/Er7im

When eDetailing was relatively new in 2003 -- before the dawn of Web 2.0 -- there were about 90,000 pharmaceutical sales reps. In 2007, just when the hype about Web 2.0 began and the physician social networking site Sermo was launched, the number of sales reps peaked at 102,000. Today, there are about 92,000. In 2012, ZS Associates predicts the number will be 75,000 -- the lowest since 1996 when the sales rep expansion was just starting.

About 45,000 doctors meet with detailers using online video, and 300,000 physicians say they are open to doing so, said a September 2008 study from Manhattan Research. This trend is worldwide. Tomorrow, in an exclusive interview with Mark Bard, President Manhattan Research, we will talk about technology adoption and integration trends in physician practices across Asia (see "Taking the Pulse™ Asia: Asian Physicians and Emerging Information Technologies").

There seems to be a correlation going on here -- one that sales reps have long feared: as pharma adopts the Internet for reaching physicians, they will start getting rid of sales reps. Those that supported the adoption of eDetailing by the industry used to allay these fears by saying things like "the best eDetailing programs work hand-in-hand with the sales force" and "eDetailing should complement the sales force" (for more on the history of eDetailing, you can order the eDetailing Supplement to Pharma Marketing News. Use the discount code 'EDET64297N' and save $7).

You may no longer hear concerns from pharma people -- except from sales reps -- about eDetailing replacing sales reps. And developing programs that "complement" the sales force may now have less appeal. "Drugmakers are responding to hard times with layoffs and a shift toward online marketing," proclaims an article in today's American Medical News ("Doctors increasingly close doors to drug reps, while pharma cuts ranks").

The current recession offers pharma (and other industries) a great opportunity to adopt new technology! You can lay off people and replace them with off-shore resources (see "Pfizer Pfires Thousands of Americans, Outsources Tasks to India") and/or with new technology (eg, social media).

To be sure, visits by drug reps will not disappear entirely. The hope is that the sales force that survives the layoffs will be "better trained and have a greater depth of clinical and scientific knowledge," according to experts cited in the American Medical News article.

FDA Warns Drug Firms Over Internet Ads

source: Wall Street Journal

By JARED A. FAVOLE

WASHINGTON -- The Food and Drug Administration warned 14 major pharmaceutical companies about brief Internet ads that accompany searches on Google and other search engines, saying the ads were misleading because they didn't include risk information.

The warnings marked one of the first major actions by the FDA to crack down on Internet promotion, which is taking a bigger chunk of pharmaceutical marketing budgets because many people use search engines to find out about health problems.

The ads cited by the FDA typically come up as "sponsored links" when people type a disease name or product name into a search engine. Most of the world's largest pharmaceutical companies were among the 14 that received FDA warning letters.

One letter went to Biogen Idec Inc. over its multiple sclerosis drug Tysabri.

The ads say "A Multiple Sclerosis Treatment That's Different from the Others" or "Satisfied with your MS Medication or Looking for Something Different?" but don't include any risk information, according to the FDA.

"Their casual approach to Tysabri treatment is extraordinary in light of the potentially lethal risks of the drug and the stringent controls over its distribution," the FDA said in its letter to Biogen on March 26. The letter was posted on the agency's Web site Friday.

Tysabri has been linked with a serious brain infection in several patients and is marketed under restrictions designed to reduce the risk of the side effect.

The company is working closely with the FDA to resolve the situation, said spokeswoman Naomi Aoki. She said the company takes its responsibility to communicate the risks and benefits of Tysabri "very seriously."

Biogen's ad includes a link to the Web site for the drug, which does contain the relevant risk information. The FDA said the link "does not mitigate the misleading omission of risk information from these promotional materials."

Sanofi-Aventis SA received a warning for ads for Plavix, a powerful anticlotting drug that is the world's second-largest drug by sales after Pfizer Inc.'s Lipitor. "The sponsored links misleadingly suggest Plavix is safer than has been demonstrated," the FDA letter said.

The FDA wants the companies to remove the ads that contain violations and respond to the agency next week.

The FDA looked at the ads as part of its routine monitoring of Internet advertising, said agency spokeswoman Rita Chappelle. She said the FDA hasn't contacted any of the search engines where the ads have appeared because the agency doesn't contact third parties that carry ads, even if violate agency rules.

Some of the letters include complaints about multiple drugs. For instance, a letter to Pfizer mentions six drugs, including its antismoking drug Chantix and the arthritis medicine Celebrex.

Ms. Chappelle said 19 of the 48 drugs cited in the letters carry the agency's strongest warning, a black box, about possible side effects.

She said in some instances the information on the ads expanded uses of the drug beyond what they are approved for.

The other companies that received letter are: Johnson & Johnson, GlaxoSmithKline PLC, Forest Laboratories Inc., Cephalon Inc., Bayer AG, Novartis AG, Merck & Co., Eli Lilly & Co., Roche Holding AG, Genentech Inc., and Boehringer Ingelheim Pharmaceuticals Inc. Genentech was recently acquired by Roche.

A Pfizer spokesman said it is important to communicate information online about diseases and treatments, and the company will reassess its use of sponsored links to ensure adherence to FDA guidelines. Representatives of the other companies weren't immediately available for comment.

—Alicia Mundy contributed to this article.
Write to Jared A. Favole at jared.favole@dowjones.com

FDA issues warning letters to 14 pharmaceutical companies for paid search ads; blogger John Mack responds

This is a repost of John Mack's blog posted 4/209
For the original blog post, click here: http://bit.ly/141HW1

FDA's Actions Speak Louder than Its Words: On the Internet It's the Medium as Well as the Message!

It has been widely reported that as far as the FDA is concerned it's the message not the medium when it comes to regulating pharmaceutical use of the Internet (see, for example, "A Conversation with the FDA Associate Commissioner for Public Affairs"). This is turning out not to be entirely accurate.

In 14 recent warning letters, FDA challenged the conventional wisdom of consultants to the drug industry about application of the so-called "one-click rule" to Google Adwords. Clicking is unique to messages delivered via the Internet or other interactive media.

The "one-click rule" states it's OK on an Rx product Web site to merely provide a link to the package insert or brief summary. The "rule" was an interpretation of FDA thinking by consultants to the drug industry and was never something the FDA ever claimed as a rule it would use to regulate drug information on the Internet. When I challenged the existence of any such rule, these consultants backed off and called it "received precedence" rather than a rule (see "Death of the One-Click 'Rule' or 'Received Precedent' or Whatever!").

With these additional FDA letters there is much more "received precedence" to indicate that the rule or whatever does NOT apply to Google Adwords (see "The 'One-Click Rule': Rant or No Rant?" for more on that).

The Wall Street Journal reported that "The Food and Drug Administration warned 14 major pharmaceutical companies about brief Internet ads that accompany searches on Google and other search engines, saying the ads were misleading because they didn't include risk information." (See "FDA Warns Drug Firms Over Internet Ads").

The ads in question were similar to this Lunesta Google Adword that I first talked about in 2006 with my infamous "Girl from Google" post (see ad below). Google actually advised their pharma clients to create such ads.

In my 2006 blog post, I warned pharmaceutical marketers to be wary about using such tactics and called these ads "bAdwords."

My argument was simply that an AdWord could be said to comply with the one-click "rule" only if within the AdWord text there was a direct link to the package insert (PI) or brief summary. In most Adwords there is a link to the product Web site where the consumer would have to click on a second link to get to the PI. I didn't think two clicks would pass muster with the FDA. After 2 and half years I am proven correct.

One FDA letter went to Biogen Idec Inc. over its multiple sclerosis drug Tysabri (find letter here). "Biogen's ad includes a link to the Web site for the drug," said the WSJ article, "which does contain the relevant risk information. The FDA said the link 'does not mitigate the misleading omission of risk information from these promotional materials.'" See violative Tysabi Adwords below. On the left is the sample provided by FDA. On the right is the one I just found myself.

You can see how easy it is for pharmaceutical marketers to follow bad advice from consultants in the absence of CLEAR GUIDELINES from the FDA. Instead of regulating through "received precedence" the FDA should follow common regulatory practice and issue PUBLIC guidance on the use of the Internet for promoting drugs and devices.

How the FDA develops this guidance is as important as the guidance itself!

To help determine what the best procedure is, I have developed a survey that presents several different procedures the FDA could use to develop guidance for the use of the Internet and specifically social media for the promotion of drugs and other medical products it regulates.

The options are:

1.Before issuing and draft guidance, FDA should convene a public hearing in which ALL the stakeholders can put on record their suggestions and concerns.

2.FDA should consult privately with drug companies and then issue draft guidance open for public comments according to normal rulemaking procedures.

3.FDA, without ANY prior consultation with drug companies, should issue draft guidance open for public (including industry) comments as per normal rulemaking procedure.

4.If FDA solicits public comments -- no matter in what fashion -- it should publish ALL the comments it receives.

Please take the survey and indicate your level of agreement or disagreement with the above options/statements. Be sure to add comments as well. Thank you.

Headlines on FDA's Paid Search Warning Letters to Pharma

April 4 Headlines regarding FDA's paid search warning letters sent to 14 pharmaceutical companies:

FDA Warns Drug Firms Over Internet Ads
Wall Street Journal

FDA's Actions Speak Louder than Its Words: On the Internet It's the Medium as Well as the Message!
Pharma Marketing Blog

US cracks down on misleading drug internet advertising
The Australian

FDA Chides 14 Drug Makers for Misleading Internet Ads
BioJobBlog