The internet was blazing hot yesterday and today about the latest, in now an ever-growing list of transparency issues with Big Pharma and blockbuster drugs. The latest victim – Roche’s Tamiflu. According to a recent analysis published by the British Medical Journal, it was concluded that Tamiflu had “modest effectiveness” against the symptoms of the flu in otherwise healthy adults — cutting symptoms by about a day.
The report, an update of a 2005 analysis by Cochrane Collaboration, excluded eight studies funded by Roche that haven’t been published and whose full data wasn’t given to the researchers. The exclusion reversed the group’s earlier finding that Tamiflu protects against complications.
The report raises questions about how drugs are reviewed, approved and distributed, Fiona Godlee, the British journal’s editor in chief, wrote in an editorial. The studies originally used to establish the benefits of Tamiflu were written by Roche employees and paid consultants, under-reported serious side effects and failed to clearly identify all the authors, she wrote. In at least one case, a study was attributed to a researcher who disavowed any involvement to the journal, Godlee wrote.
OK, so I will start with a hint about my age: Do you remember where you were when Neil Armstrong first walked on the moon? (We are approaching the 40th anniversary of the date, July 21, 1969.) I was on the beach in Wildwood, New Jersey with my then girlfriend, now wife. She was incredible and so was the idea of a man on the moon. It was wondrous to look at the moon and realize that we were able to send someone so far away and then bring him back. Space launches are so matter-of-fact today, but it was such an accomplishment then, something that our country was so proud of. (Remember the Cold War?)
Something more recent and not nearly as memorable: Can you remember where you were when someone first described Twitter to you?
I was having lunch with an account executive and a client in Boston, and the client was tweeted. He went on to tell me about Twitter, what he tweets about, and who he follows. He was so into it, so excited about this new communication, this ability to have conversations with people that he did not know. The account executive got really engaged in the conversation, but frankly I did not get it. As a matter of fact, I am certain that the face I had on that day, as much as I tried to hide it, is the face that I still have today when someone talks about Twitter. You know… squint a bit, furrow your brow, and non-verbally say, “What? Why would anyone want to do this?”
So how did your face look (not Facebook) when you first heard about Twitter? What was your expression?
What did you think? What does it say about us if I think WITFITS about Twitter and you think 2G2BT? Do you think this difference is age? An ability to two-thumb type 200 words a minute on our Blackberries or iPhones? I never thought the Internet provided too much information. I don’t know how we conducted business without it. But Twitter, I don’t know. TMI with too little value to be sure.
Take a look at some comments here. I am sure that following Charlie on Twitter is a small part of a much bigger idea, but this use of Twitter seems forced to me. (I can read it now: CSA, we can use Twitter, millions will follow Charlie!) IDTS (or IBTD for the polite types). Here we have a paid spokesperson who is an open-wheel racecar driver, diabetic, and racing while on Levemir® (insulin determir [rDNAorigin] injection). Twitter is filled with abbreviations, not registered marks. Does anyone know how to make a registered mark on a Blackberry? When does Charlie get a chance to Twitter during a race? During a pit stop?
And what’s the point?
A diabetes patient reads this and says, “Gee, I want to be just like Charlie, and I will use Levemir! Let me click on the full prescribing information!” Maybe the more likely response is, “Even though I am a diabetic, I can still live a fun life filled with occasional episodes of terror as I am passing on a curve at 200 mph! Let me follow Charlie as I find out how he does it.” IDGI!
I also want to get the medical regulatory review process of this. So Charlie wants to tweet (and 200 followers can’t wait to read it.) “At the Dodger game! Beautiful day for the All American game.” As Charlie can elect to tweet at anytime during the day, there is an on-call group to review the statements. In the review meeting, someone points out that this comment could be seen by the FDA as a quality of life claim. Does the labeling for Levemir include “more beautiful days” or is this claim not supported by two controlled trials? So it gets changed to “At the Dodger game! Baseball is the All American game.” But wait! Novo Nordisk is a Danish company, and the Dodgers are hardly all American. They have players from Venezuela, the Dominican Republic, Japan, Korea, Mexico, and Taiwan. So it gets changed to “At the Dodger game!” But wait! When did Charlie take his Levemir? We want to ensure compliance here. So “Just took Levemir®” (note the trademark) is added, and the link to full prescribing information is included. OK Charlie, go ahead and send this spur-of-the-moment tweet out to your followers. Whew!
Let’s think about this for a minute: Long, long ago, Boots ran the first DTC ad to support their ibuprofen product Rufen.
The campaign involved regional TV and national print, including an ad with a $1.50-off coupon. ($1.50. Times have really changed!) The ad claimed Rufen was the same as Motrin but less expensive. (Motrin was one of the first Rx-to-OTC switches, but this campaign came out while Motrin was an Rx drug.) At the time, all hell broke loose, the FDA put a moratorium on DTC ads, and it was years until the next ad for a prescription drug was seen. Who would have thought at the time that this ad would lead to the $5 billion DTC environment that we are seeing today?
So who is to say that Charlie Kimball won’t be the start to a Twitter cacophony of pharmaceutical tweets?
NIMY! Look, I don’t want to come across here as an e-anderthal. Or Twitter-dumb. In fact, I believe that there are lots of situations where social media, particularly social media with an invited community, could be a great communication solution. I believe an agency has to look at each situation and recommend solutions to clients that solve their problems and meet their needs. Just like any other media, social media is not the solution for every situation, so we should not try to apply it everywhere. But at least for now, I don’t see Twitter as a rich enough communication vehicle to carry the complex messaging of healthcare. ICBW, but I don’t see Twitter lasting. I certainly don’t see it being as memorable as the first man on the moon.
If you are as confused by the acronyms as I was, visit NetLingo for a list of commonly used acronyms and shorthand.
Coming to a mobile phone (Android and iPhone) near you, in the not so distant future, is the world’s first Augmented Reality Browser – Layar. Layar is a free application for your mobile phone, which shows what is around you by displaying real time digital information on top of reality through the camera of your mobile phone.
Layar is derived from location based services and works on mobile phones that include a camera, GPS and a compass. By looking through the phone’s camera lens, a user can see houses for sale, popular bars and shops, jobs, etc. I can see a world of opportunity for the healthcare industry, especially for providers and physicians. What do you see?
Trends, trends, and more trends. Love them or hate them, ‘experts’ write all about them and the market clamors to read them. So what can we expect in 2010 from pharma marketers? A little new, a sprinkle of old, and a ton of catching-up with traditional marketers. The following is a list (in no particular order) of what pharma marketers should be concentrating on in 2010 (if they aren’t already).
Creativity (new and creative ways for consumer and physician outreach)
User Generated Content (when applicable)
Cost-Per-Click/View marketing (FDA, you have been warned)
Qualitative Analytics (social media metrics)
Social Media (insights, research, transparency, corporate presence)
Mobile advertising (apps and consumer engagement)
Online video (cme, patient education, detailing)
And for more on the digital market, see Manhattan Research’s presentation below.
In pharmaceutical advertising, we find ourselves in a state of constant regulation as everyone tries to ensure each piece created meets FDA requirements. This struggle between advertising the benefits of a drug and satisfying the necessity to indicate the risks (in increasingly larger quantity and size) is one we face daily. With the recent release of the draft form of Guidance for Industry Presenting Risk Information in Prescription Drug and Medical Device Promotion , a set of non-binding recommendations for print and broadcast promotion, the FDA is attempting to help us along. The stated goal of the draft guidance is to clarify the factors the FDA considers in evaluating ads and promotional labeling for prescription drugs and restricted medical devices.
Overall, the FDA is clarifying the presentation of risk information so that it is equivalent to the presentation of benefit information, which is nothing new. But they are doing this by including more detail and examples. Their examples and occasionally vague language indicate how tricky this situation can be, not only for advertisers but also for the people doing the regulating.
One of the most exciting aspects of the draft guidance is the fact that the FDA will be accepting comments and suggestions for a 90-day period. Though no one can say for sure if the FDA will implement the suggested changes they receive, now is the time to review these draft recommendations and share your thoughts. If you think the examples they provide are not sufficient, you should request more, better examples. If you think their recommendations aren’t practical, you should tell them that and explain why. Maybe they’ll agree. We now have the opportunity to perhaps gain some control over a situation that affects pharmaceutical companies and advertisers daily. We shouldn’t let that opportunity pass without at least trying to make a difference.
Comments and suggestions can be submitted until August 24, 2009. Be sure to include the docket number, FDA-2008-D-0253, from the notice of availability that came out on May 27, 2009.
Send comments to
Division of Dockets and Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Okay, I have a confession to make. Two, actually. The first is that, in the spirit of recycling, this post is an adaptation of an article I wrote for Talent Zoo late last year. The second is that despite having been a copywriter for fifteen years and a creative director for ten more—running my own eponymous and award-winning agency for five of those years and for the rest working at some pretty well-regarded agencies (by my industry’s standard, at least) in five countries—some ad types reading this might say that I’ve never quite fully managed to actually get into advertising, really.
You see, the fact is that those twenty-five years were spent in medical advertising. And not in the making of those boomer-disorder TV spots that everyone loves to hate—there’s still some fame (or infamy) in that. No, they’ve been spent devising the printed sales aids and journal ads and patient education leaflets through which the pharma industry seeks to persuade your physician to prescribe its products as the cure for what ails you, at any given time.
Now, while medical advertising used to be a fabulous generator of income (days long gone, by the way), it has never been regarded by the ad industry as a generator of high-profile creative executions.
Notice I say executions and not ideas; I firmly believe that this arm of the business has been as fecund and fruitful a hothouse of great communication ideas as any other—just too often obscured by graphs and tables and complicated words in the headline. Nowadays, though, I’m no longer as sure of that as I used to be. Frankly, we’ve had the stuffing regulated out of us. Especially those of us who’ve been at it for a while.
It used to be that medical creatives could feel good about themselves, amongst themselves.
We had our own award shows that sorted the wheat from the chaff, and we could look smugly down our noses at simpletons selling soap powder and sugar water, knowing that we were helping to keep the smartest folks around properly informed about up-to-date ways of treating cancer, cardiac disease, and chronic whatever. We felt like the intelligentsia of advertising and our victories were accomplished through the crafting of ideas; through metaphor, storyline, and okay, admittedly, sometimes even hyperbole. Never mind that our more glamorous industry-mates might think we were dorks. We knew a good idea when we sold one. Masters of nuance, we could weave sophisticated arguments from raw clinical data and infer advantage despite a product presenting a Package Insert (upon which all claims must be based) of mind-numbing parity with its competitors. Well, we’ve had that bashed out of us and then some.
The very idea of an “idea” is now anathema to the FDA, and many big pharma companies have outsourced risk assessment to ex-FDA consultants whose job it is to say “no” to everything and strip value from their client’s communication efforts.
And get paid handsomely for doing so! Ironically, and luckily for the pharma industry, this comes at a time when the medical advertising creative workforce has never been so well trained, contextually experienced, adept at its craft, and simply dying to do something special.
As usual, it’s the young ‘uns that are leading the charge. A client once told me that there would come a time that “one’s experience counts against one.” I’ve been battling with that for a while, tilting at the abovementioned windmills, but I think I’m starting to see light at the end of the tunnel, or some other reassuring cliché. Heretical as it may seem, I’m starting to believe that everything old is new again. After all, if all the creatives and all the customers and all the clients are thirty-something or younger (at least, those with any sort of authority), then all the archetypes are up for grabs. If the medium is the message, then the message is new.
YouTube and URLs wash away the sins of the past. Everything’s a mashup, fresh, immediate, and potent as ever. Sample Aesop’s fables in Flash and voila, you’re golden. And why not? After all, our genes are millions of years in the making. Originality? Oh, please. As long as it sells, baby. As long as the client is happy and it sells. And who’s to say that each time an idea is revisited in this way it isn’t executed with more refinement and, conceptually speaking, more appropriately applied? I think that this is very often the case.
If my confession sounds disgraceful, let me offer this up in my defense: I have the privilege of presiding over a tremendously talented creative department full of enthusiastic, fresh-faced young copywriters and art directors who never fail to amaze me by the brilliance and breadth of ideas they put up on the wall for every assignment. Often, the most apt of these involves a metaphor, and occasionally I have seen similar ideas before, maybe twenty years before. But I’m sure I only thought they were original then because I was too young to know any better.
I think it was T.S. Elliot who said that everything’s been done, it’s only the combinations that change, (someone else probably said it before him, right?) and the older I get the more I concur. Change the combination, change the medium, change the culture even, and you change everything. I increasingly find that those metaphors steeped in cultural relevance, those “old” ideas, are the ones the clients like the most, that undeniably float to the top in market research and that the physicians relate to best. Faced with success like that, me casting aspersions on their vintage can seem like sour grapes. It can suck enthusiasm from the building. I’m really trying to stop doing that. So, if the current regulatory climate precludes developing narratives of cutting-edge novelty, we always have the classics, and thank goodness. I’ll settle for sales, and keep my ego out of it. Plus ça change, plus c’est la même chose, as they say.
The debate over who should write medical journal articles has been raging for years. Although heated and passionate at times, these debates are often imprecise about what constitutes ghostwriting or what possible benefit there is in employing a professional medical writer. Let’s clear up some half-truths and misconceptions.
He’s not a ghost if you can see him.
There are definitely ghostwriters among us. At its most extreme, ghostwriting is the use of an invisible writer hired by the marketing department of a pharmaceutical company to produce a selectively favorable report of their product, with authorship attributed to a high-profile investigator whose sole participation is cashing their honorarium check. This extreme example is shunned by most who are responsible for producing medical communications. More often than not, journal articles are written by medical writers who adhere to rigorous ethical guidelines (EMWA, ICMJE, WAME, AMWA). Central to appropriate medical writing is close collaboration of the professional writer with faculty authors who direct and control content.
Who are you going to call?
Another crucial aspect of professional medical writing is transparency. Successful medical publications are a team effort. Just as physicians investigate, statisticians calculate, and peer reviewers authenticate, the job of the medical writer is to communicate. Skilled medical writers perform the time-intensive tasks involved in clarifying and translating data into a submission-ready manuscript. Full disclosure of the contributions of all members of the team is essential to restore trust in medical literature.
Is it time to give up the ghost?
Investigators cite limited time as the most common reason why they do not convert clinical trial data into publishable manuscripts. A 2005 study of publication rates of oncology clinical trial data found that up to one third of clinical research in oncology remains unpublished. A recent survey for the Food and Drug Administration found that encouraging the participation of medical writers would help reduce the non-publication rate associated with industry-sponsored clinical trials.
And now a word from our sponsor…
Much of our medical literature is funded directly or indirectly by the pharmaceutical industry. We need them and they need us. At our best, the collaboration results in significant advances in healthcare. A final step toward eliminating hidden biases and restoring trust in medical literature is full disclosure of industry support and open access to clinical study data.
Tchotchke—originally from a Slavic word for toys. The term has a connotation of worthlessness or disposability, as well as tackiness. The word may also refer to swag, in the sense of the logo pens, key fobs , and other promotional freebies dispensed at trade shows, conventions, and similar large events.
It appears that the time has come for banning the promotional giveaways typically offered at booths. What do you think?
Are the docs ready to give up that maze and souvenirs for their family?
While a number of the attendees at medical conventions are there for the education, there are a fair number who still enjoy the tchotchkes. What about populating the exhibit hall with simulation centers, workshops, and demonstrations? Sounds like a good idea to me; I have noticed that the lines are the longest in the booths with the simulators, rivaled only by the lines to the coffee bar and the ice cream station. So what are your thoughts? Do you think the simulation centers, workshops, and demonstrations will be the pit stops along the paths of the exhibition halls of the future?
We, as healthcare meeting organizers, need to help those who are faced with the new PhRMA and AdvaMed codes.
Exhibitors are attempting to focus on highlighting educational experiences at their booths to draw attendees. The American Epilepsy Society is exploring the possibility of helping exhibitors arrange for snacks from their booths. They are looking to help exhibitors access a popcorn machine, coffee bar, ice cream station, chair massage, or even a shoeshine stand. Do you feel that these incentives “walk the line” between meeting and violating new codes?
It’s apparent that medical associations and pharmaceutical corporations are well aware of the changes to the PhRMA and AdvaMed codes, but that’s not necessarily the case for meeting attendees.
Some of the associations have been asked how they are going to inform attendees about the changes so they understand why they’re not getting the same kinds of giveaways at exhibit booths. Randy Bauler, CEM, corporate relations and exhibits director of the American Association of Critical Care Nurses, Aliso Viejo, California is quoted saying, that AACN is putting a statement in its exhibits directory as well as notices in the conference daily. “We’ll call attention to the new codes [and explain] what that means to them, the attendees, when they visit booths,” he says. “We believe we have an obligation as an association to help educate our attendees about these changes.”
What are your thoughts on this? Do you have any ideas on how our industry can make this change, conforming to regulations while pleasing both meeting attendees and our clients? I would love to hear your comments.
