Monday, August 31, 2009

Full BOEHR(inger) Social Media Reporting of RELY Trial Results

Boehringer Ingelheim (BI's) -- the German pharmaceutical company -- has just completed the first-ever full bore social media campaign touting the results of its RE-LY® study - "the largest atrial fibrillation (AF) outcomes trial ever conducted." The results of the study were presented for the first time at the European Society of Cardiology (ESC) Congress yesterday. BI live-tweeted from the RELY press briefing and presentation in Barcelona.

The Tweets included statements like:
  • "RELY dabigatran had no liver toxicity" [Pradaxa® (dabigatran etexilate) is BI's brand anti-coagulant drug that competes with generic warfarin]

  • "RE-LY results: Significance on primary endpoints and significantly lower bleeding"
PharmaGossip also reported that the word "Impressive" was used in a BI Tweet to describe the results and asked "Boehringer's twittering at the ESC - is it being approved by their internal regulators?" This morning, I cannot find the @Boehringer Tweet PharmaGossip refers to -- maybe BI deleted it -- but the word "impressive" is used in the official press release. Therefore, I assume whatever is being posted on Twitter HAS been approved by BI's regulatory/legal people.

Demand is high to get into the RELY press briefing on TwitpicBI also used Twitpic to show us that "Demand is high to get into the RELY press briefing" (see photo).

Not only has BI used the free services of Twitter and Twitpic to promote the results of this clinical trial, it also uploaded new videos on its new new Boehringer Stroke Prevention YouTube channel.

On August 27, 2009 it uploaded the video entitled "Day in the life of a Warfarin patient," which has an actor portraying a patient who complains about the problems he has with warfarin treatment.

As promised, the YouTube channel is also "packed with RE-LY trial information."

That's a lot of promotion for very little money!

BI seems to be ahead of the pharma pack in using social media to woo journalists and physicians rather than the general public via Twitter and other social media. I discussed this strategy with Judith von Gordon, BI's Head of External Communications, and John Pugh, BI's Director of Corporate Communication/External Communications, in a June, 2009 Pharma Marketing Talk podcast (see "Boehringer Ingelheim Pharma on Twitter: Boehringer Ingelheim").

Friday, August 28, 2009

Twitter for Brands: Beyond Marketing

Yesterday, I posted one simple idea: pharmaceutical company employment of Twitter to notify patients about drug recalls, counterfeit drugs, or drug safety warnings (see "Twitter and Drug Safety: A Paramount Concern").

There has been an interesting discussion in the comments to that post, including comments from representatives of Novo Nordisk and Johnson & Johnson. I also had some good reactions from my Twitter pals such as the following:
  • RT @MaverickNY: RT @pharmaguy Pharma shld use twttr 2 warn patients abt drug recalls, counterfeits, warnings, etc. eg, Levemir... /Gr8 idea! (posted by @blogaceutics)
  • @pharmaguy Really interesting perspective on Pharmaceutical Industry and Twitter. (posted by @askfrasco
  • Liked: Twitter and Drug Safety: A Paramount Concern (by @pharmaguy) (posted by @andrespong)
  • RT @MaverickNY @pharmaguy Pharma should use Twitter to warn patients about drug recalls, counterfeits, warnings eg, Levemir... /Great idea! (posted by @whydotpharma)
  • Great perspective from @pharmaguy on "Twitter and Drug Safety: A Paramount Concern" (via Pharma Marketing Blog) (posted by @DUrbaniak)
  • @pharmaguy argues that Twitter should not just be a marketing tool for pharma but a consumer safety mechanism too (poseted by @Media_Allori)
  • A capital idea! RT @pharmaguy: If patient safety is paramount concern, use Twitter to notify patients of probs: (posted by @fredgebhart)
  • RT @pharmaguy Pharma should use Twitter to warn patients about drug recalls, counterfeits, warnings, etc. eg, Levemir... /Great idea! (posted by @MaverickNY)
  • @pharmaguy Right on ! They should allow users to register at product websites for new information (posted by @richmeyer)
What was a half-baked idea yesterday has morphed into the idea that individual drug brands should have Twitter accounts to support patients who use the brand.

Virtually all pharmaco Twitter accounts spew out corporate communications that are not likely to be followed by many patients. Novo Nordisk, which has a Levemir-branded Twitter account (Race with Insulin), is the exception. However, that account so far has focused only on marketing (see "Novo Nordisk's Branded (Levemir) Tweet is Sleazy Twitter Spam!") and posting the daily trials, tribulations, and hopefully victories of spokesperson with diabetes and racecar driver Charlie Kimball (see "Charlie Kimball, Novo Nordisk, and Me Make Up"). It offers very little in terms of patient support.

A branded, patient support Twitter account can be used for more than just issuing safety alerts. The following are just a few ways that a branded Twitter account can be used for this purpose (I've taken many of these suggestions from @philbaumann's post: "140 Health Care Uses for Twitter"):
  • Drug/device safety alerts (eg, drug recalls, medical device malfunctions, emerging safety issues)
  • Prescription management, including pharmacy refill reminders
  • Daily health tips from authoritative sources
  • Publishing disease-specific tips
  • Clinical trial awareness
  • Enhancing health-related support groups (e.g. buddy-systems for depression)
  • Providing around-the-clock disease management
  • Patient-sharing of health-related experiences
  • Issuing dietary/lifestyle tips
  • Adherence and compliance messages
  • etc.
A branded patient support Twitter account can deliver appropriate messages to followers who opt-in to follow via notices on the web site as @richmeyer suggests. Because of the viral nature of Twitter, one follower can lead to many more with very little extra effort or expense on the part of the sponsoring pharma company. If the posts are relevant to patient needs, followers will RT (re-tweet) and recommend that others follow.

Unbound by Time and Location!
@blogaceutical made an observation via another Twitter discussion thread that Twitter allows users to communicate with a lot of people immediately. This makes Twitter useful for sharing time-critical information such as drug safety alerts.

Because you can also receive Tweets via your cell phone, you can receive text-message Tweets wherever you are. On the iPhone, of course, you can use Twitter apps to view Tweets integrated with the Web browser. Twitter, therefore, is the perfect mobile application for patient support.

One of the best features of Twitter, IMHO, is the 140-character limitation. No one has time to read lengthy messages. However, Tweets can include links to the patient support area of the Web site where patients can get as much information as they want, when they want it (assuming the Web site has the expanded information).

What About FDA Regulations?
Whenever we are talking about a pharma-sponsored new media branded application, we have to consider how the FDA would react to it. Unfortunately, FDA has not come up with any guidelines we can use, so we have to read the tea leaves and use precedents to guide us.

Obviously, a branded patient support Twitter account would juxtapose brand name and indication on the Twitter account home page. It must, therefore, have the necessary fair balance information. Race with Insulin is an example and may be a precedent to cite. However, FDA may yet review Novo's use of Twitter and declare it violates the law.

However, I don't think any of the above uses of Twitter for branded patient support will run afoul of FDA regulations as long as marketing is kept out of the picture. That is, patient support Tweets do not need to mention product benefits.

@MeredithGould noted "This would require actually training people how to use Twitter properly and well." Very true. Recall that Lilly got into a lot of trouble (with the FTC) for sending an inappropriate email message to patients. The message was "inappropriate" because it included the email addresses of all recipients in the CC line, which was visible to everyone who received the email.

With Twitter there is no personal information that can be inadvertently shared with all recipients of Tweets (except the personal information Twitter users reveal about themselves). However, personnel who write the Tweets must be trained how to do it without breaking any laws or regulations and in compliance with corporate/brand goals as well.

As always, there are many nuances to consider and barriers to overcome to implement what I am considering. It would be great if these ideas were discussed at conferences so that solutions could be found and shared. I welcome your opinion on this. Please take the following survey on how effective Twitter can be in carrying out patient support activities/communications:

What's Your Opinion About Branded Patient Support via Twitter?

Wednesday, August 26, 2009

Twitter and Drug Safety: A Paramount Concern

There's a lot of talk about Twitter and how pharmaceutical companies should or should not use Twitter. Most of this focuses on using Twitter to promote drugs and dialogue with the press in order to present the industry's side of the story.

One thing I never, ever heard anyone suggest as a good use for Twitter is notifying patients about drug recalls, counterfeit drugs, or drug safety warnings. I guess it's too much to expect drug companies -- who claim to have the well-being of patients as their number one priority -- to notify users of their products about problems.

For example, the FDA and Novo Nordisk recently warned healthcare professionals about stolen vials of Levemir insulin. This was noted in a Novo Nordisk press release, but not on the Web site. "The safety of our patients is of paramount concern," said Novo in the press release.

Insulin from stolen lots did not circulate through the normal Novo Nordisk distribution channel and therefore proper storage conditions for the insulin may not have been followed. Patients taking this insulin could be in danger.

The stolen insulin story was in the news again today. Many people also Tweeted about it. @racewithinsulin -- Novo's official Levemir-branded Twitter account -- did NOT tweet about it. Too bad, because I think this is the kind of information people who take Levemir and follow Charlie Kimball on RaceWithInsulin would like to hear about.

Now, I met Charlie and he's a busy guy and he should not have to keep up with all the news about Levemir. RaceWithInsulin is really more about Charlie's adventures than it is about Levemir per se. So I guess I should not expect him to post this kind of information on Twitter, although it might be a nice gesture anyway.

Let's not just focus on Novo and Levemir. FDA recently issued an early safety communication about alli, GSK's weight loss OTC drug (see "Orlistat (marketed as Alli and Xenical): Early Communication about an Ongoing Safety Review"). There was no mention of this on GSK's Twitter page (@gskus).
BTW, the orlistat safety issue is addressed in this discussion thread. I note that MY message was NOT used (see "Will Alli Soon Be the Only FDA-UNapproved OTC Drug?").

The thread "liver damage" was started by this post: "Heard on the news that some Alli patients have had liver damage, they are doing a investigation into the drug. How do you respond to this? Also, what is a safe amount of time to stay with the pills. My thinking is you establish good habts with a low fat diet, then wean yourself off the pills. Has anyone reported problems with liver absorption after taking the pills? I'm almost afraid to continue, please repsond asap so I can feel safe to continue with my plan. I've lost 11 lbs in 3 months, and would like to loose more."

Maybe this post was written by a real consumer, maybe not. At least GSK addressed the issue.
But, IMHO, Twitter is a better way to notify patients about potential serious problems with drugs and fulfill the promise of making patient safety a "paramount" concern (a concern above all others) of drug companies. So why don't we see it used that way?

P.S. I neglected to mention that my Twitter pal @PhilBaumann has suggested many ways that pharma and other healthcare organizations could use Twitter aside from marketing & PR. See "140 Health Care Uses for Twitter."

Tuesday, August 25, 2009

Will Alli Soon Be the Only FDA-UNapproved OTC Drug?

Alli has long been promoted as the "only FDA-approved over-the-counter weight loss aid." Soon, however, alli may be known as the "only FDA-UNapproved over-the-counter weight loss aid."

That's because the FDA just issued an "Early Communication about Ongoing Safety" for orlistat, marketed as Alli and Xenical. Specifically, FDA is reviewing 32 reports between 1999 and 2008 of serious liver injury in patients taking orlistat. All but two involved prescription Xenical and occurred outside the United States (see here).

FDA, however, recommends that "Consumers currently taking Xenical should continue to take it as prescribed and those using over-the-counter Alli should continue to use the product as directed."

Should consumers of these products be concerned?

I asked that question on the community discussion board, where I posted this message;
Subject: Should I be concerned.

Message: Yesterday I learned that the FDA was investigating serious liver injury events caused by orlisat - the drug in alli (see Although the FDA said to continue taking alli, I am concerned. Since I have no doctor to advise me, I wonder if I should stop taking alli.
The message is currently awaiting moderation. I'm not holding my breath for approval any time soon.

Consumers taking prescription Xenical at least have their doctors who they can call for advice. I suppose that people taking alli can ask their pharmacist. Maybe I'll try that this afternoon and see what he says.

Bu don't expect GSK to notify visitors to about the FDA's early communication and offer any advice.

Of course, the early communication may turn out to be a false alarm. But it also may lead to further action such as a "black box" warning added to the product labeling (for Xenical) as was the case with Chantix.

But what can the FDA demand to be put on the labeling (box and promo materials) for alli, which is an OTC product?

From wikipedia, I learn that the FDA requires that OTC products be labeled with an approved Drug Facts label that includes safety information. It's possible, therefore, that alli's label may need to be changed if FDA concludes there is actually a safety issue. Considering that the FDA issued some strong warnings about Tylenol and other OTC pain medications, it just might happen!

Monday, August 24, 2009

No FDA Regulations Would Be Like Driving on a Highway Without Speed Limits

My friend Jonathan Richman asks an interesting question on his blog: "What If There Were No Rules in Pharma Marketing?"

“What If There Were No Rules?', asks Richman. "There’s no FDA, no DDMAC, no FTC. Your company guidelines and rules don’t exist and your regulatory and legal teams have been disbanded. It’s a free-for-all and there are no rules. The question is: what would you do?"

He includes a nice survey of readers that I encourage you to respond to. But before you do that, have a look at my own parallel survey that may encourage you to think about an analogy to the real world: What if there were no laws against speeding?

After the Road Trip with my son (see "I'm Back from My Road Trip South!"), I know that I would not like to live in a world without speed limits!

Pharma, Freedom of Speech, and Ad Agencies

"Freedom of Speech" is a "right" that many commercial entities claim when defending advertising practices. The pharmaceutical industry, for example, has cited their first amendment rights when defending direct-to-consumer advertising (DTCA) from Congressional foes who wish to limit or ban DTCA altogether.

However, it is common practice for individual pharmaceutical companies to limit the first amendment rights of agencies that create DTC and other ads for them. They do this by requiring agencies to sign non-disclosure and work-for-hire agreements before they are hired as an agency of record. Practically all corporations do this, not just drug companies. Corporations are not democracies except when it suits them.

Click on image to enlarge and read.

Recently, the issue of limiting the rights of pharma agencies came to my attention via a new (to me) blog I discovered via Twitter: "Pixels & Pills." This blog is a collaborative effort between Palio and Zemoga, two creative and complementary marketing firms that have been working together for over eight years.

Last week, the blog published a post by Guy Mastrion, Palio's Chief Global Creative Officer, entitled "The FDA, Freedom of Speech and the Web." In that post, Mastrion complained that one of his pharma clients asked the agency to remove a creative piece his agency did for them. The drug company client cited FDA regulations as the reason:
"Recently a client asked us to remove work that we created for them from our corporate and personal websites. The reason for the request, as understood by us, was out of concern that the work could be viewed out of context and not in compliance with FDA guidelines. The client felt at risk for being cited for non-compliance and possibly even fined."
Mastrion also used a hypothetical patient-created content situation to imply that the FDA stifled free speech not just for pharma companies, but for ordinary citizens as well.
"So, let’s say a person living with diabetes sees an ad for a diabetes product, and is compelled to copy the ad from whatever website they happen to be on. Then she notices a bit of copy from another source, it could be poetry, that perfectly supports her idea or feelings, so she copies that and then posts it to a site of her own or a social media site. This information, now taken out of context, is an expression of her freedom of speech but it also flies in the face of FDA guidelines."
Of course, the FDA has absolutely no jurisdiction over what you or I say on the Internet. So this hypothetical patient case is just a red herring that Mastrion uses to raise our ire about his own predicament with his pharma client, which is a completely different situation. As an agent of the pharma company in question, Palio is subject to FDA regulations whenever it makes claims about a drug product it has helped its client promote.

"As an agency," says Mastrion, "our ability to attract new clients requires us to be able to promote ourselves, and prospective clients expect to see case studies of work done for others. Our website and other areas of web presence provide unique opportunities to showcase our work. To display one page of concept and often two or three pages of fair balance in the context of self-promotion to the trade seems unreasonable."

Now, I do not know what Palio did to trigger the necessity for fair balance, but I've seen many other agencies display the work they have done for their pharma clients without any problem.

A hint why Palio's case might have been different came to me when I watched one of the case studies currently on Palio's site. It was for Zometa, a drug approved by FDA to "reduce and delay bone complications due to multiple myeloma and bone metastases from solid tumors." The case study on Palio's Web site did not just present the ads it created for Zometa. It was a video history with voiceover, which at one point proclaimed Zometa as a "life-preserving product." Life-preserving, as far as I can tell, is not an approved indication for this drug. If I were Novartis (the drug company that markets Zometa), I may be worried about that claim made by its agent without providing fair balance.

Maybe Palio went even further in the case study that another drug company asked it to remove from its web site. It's possible, therefore, that the drug company rightly used FDA regulations as an excuse for removal of the case.

But, generally, it is NOT the FDA that limits the free speech of agencies -- it's the drug company clients of agencies that do that. If an agency signs a "work-for-hire" agreement with a drug company, the work product is fully owned by the drug company and the agency must have the permission of the drug company to show it as an example of its work.

Most often, drug companies do not want certain things said about its products if it has the ability to censor. Of course, no drug company can censor what I say about a product because they are not the boss of me! They are also not the boss of diabetes patients unless those patients violate laws such as copyright and trademark laws. Although I can say anything about a drug, I may not be completely free to use the drug logo. For example, I cannot create a phony Cialis blog and use the Cialis logo to make it appear to ba an official Cialis site (see "Cialis Blog Shut Down"). But the FDA is certainly not involved in these kinds of disputes.

In the case of Palio's Zometa case study, I think the client (I assume it was Novartis) has been especially forgiving. The case study mentions "sagging brand" and "fragmented branding approach" in the introduction. Of course, in the end, all problems were solved and Zometa won market share. Everyone is happy and it's a good story.

What's my point? Simply that in this and many other cases, the FDA is unjustly accused of limiting "freedom of speech" when, in fact, drug company anti-competitive policies are the primary culprits when it comes to first amendment rights of agencies and ordinary citizens.

P.S. In all my criticisms of brand products, I have never once been approached by a drug company demanding that I remove or amend my piece. I also try not to make benefit claims of drugs that are not supported by the approved labeling.

Friday, August 21, 2009

Senator Grassley Sees Pharma Ghost Writing Problems. Do You?

The New York Times recently reported (see here): "A growing body of evidence suggests that doctors at some of the nation's top medical schools have been attaching their names and lending their reputations to scientific papers that were drafted by ghostwriters working for drug companies -- articles that were carefully calibrated to help the manufacturers sell more products.

"Senator Charles E. Grassley, an Iowa Republican who has led a long-running investigation of conflicts of interest in medicine, is starting to put pressure on the National Institutes of Health to crack down on the practice."

Meanwhile, fellow pharma blogger Rich Meyer, doesn't see things that way. "Medical journal articles sponsored by drug companies are part of marketing," says Meyer. "That is a fact of a capitalist business that has to market to medical professionals. 'Ghostwriting' has been around for over 20 years and is standard industry practice for the drug industries. I personally see nothing wrong with ghostwriting as long as it is made clear at the beginning of the article who wrote it and who endorses the content." (see "Ghostwriting: What is right and wrong").

Before giving you my opinions, I would like to know what YOU think. To make that easy, I've created the Pharma-Sponsored Medical Journal Article Ghostwriting Survey. Please take 2 minutes to answer a few short questions relating to medical article ghostwriting practices sponsored by pharmaceutical companies.

Specifically, I'd like to know to what degree you agree or disagree with the following statements:
  • Medical journal articles sponsored and ghostwritten by drug companies are a legitimate part of marketing to physicians.
  • Drug companies provide ghostwriting services primarily because academic researchers are busy and some may not be skilled writers. I.e., it's NOT a marketing tactic.
  • There is nothing wrong with ghostwriting as long as it is made clear at the beginning of the article who wrote it and who endorses the content.
  • Medical journal articles sponsored and ghostwritten by drug companies are often biased (eg, emphasize the benefits of a drug and de-emphasize the risks).
  • Pharma-sponsored ghostwritten medical journal articles are ethically suspect when physicians are paid by the pharma company to add their names as authors even though they have not made a substantive contribution.
  • Physicians would never sign on as an author of a ghostwritten article that they did not review thoroughly.
  • Medical schools should prohibit their faculty, trainees and students from being authors or co-authors of articles written by employees of commercial entities if the author's name or school title is used without substantive contribution.
  • The federal government should revise research grant terms to prohibit grantees from being authors or co-authors of articles written by employees of commercial entities if the author's name or grant title is used without substantive contribution.
  • Most physicians do not care that medical journal articles are ghostwritten.
Results of this survey will be summarized in an issue of Pharma Marketing News.

Your comments are confidential (anonymous) unless you specifically provide your contact information at the end of the survey and allow us to attribute comments to you personally.

At the end of the survey you will be able to access a de-identified summary of the results to date.

SURVEY: Pharma-Sponsored Medical Article Ghost Writing
Take the survey here.

Thursday, August 20, 2009

I'm Back from My Road Trip South!

Well, I'm back in Newtown, PA and at my trusty iMac, ready to get back into all things pharma.

It's the end of my road trip south to Miami and the end of summer too.

These kids in Charleston, SC are probably back in school today.

If you've been following my Tweets (if not, see #macktrip), you know all the places my son and I visited along the way, including:
  • Lancaster, PA - where I attended Franklin & Marshall College
  • Gettysburg, PA - A very emotional experience. I have to go back and visit all the sites.
  • Front Royal, VA
  • Shenandoah National Park, Skyline Drive, VA - must return in the Fall!
  • Charlotte, NC
  • Atlanta, GA - Coca Cola museum is a great big ad for Coke! Tasting room was cool, though!
  • Macon, GA
  • Tampa, FL - Don't go to Ybor City on Monday Night. Everything's closed!
  • Sarasota, FL
  • Fort De Soto Beach, FL
  • Lido Beach, FL
  • Miami, FL
  • Palm Beach, FL
  • Savannah, GA - Sunday brunch at Lady & Sons was great. Hint: You don't have to wait if you opt for a tall table at the bar after 12:30 PM
  • Charleston, SC
  • Surfside Beach/Myrtle Beach, SC
  • South of the Border, NC
  • Richmond, VA
You can see all the sites along the way in my slide show on Flickr here.

It may take until next week for me to get back into the full swing of things.

Friday, August 14, 2009

Still on the Road - in Miami

I'm still on vacation and really enjoying the break from reporting on pharma issues!

That's me and my son, John, enjoying a beer at the Tradewinds cafe in Bayside Mall in Miami just prior to taking a sightseeing cruise. You can see all the photos of my trip on Flicker here.

We probably will leave Miami tomorrow and head back north on the second leg of our amazing Road Trip (see my route here).

Along the way, we hope to meet local people of interest. Tomorrow, for example I may meet up with some people in Palm Beach. One person wants to show me an exciting new product that will be on pharmacy shelves in the next 60 days. Another needs some advice on a new company that delivers ads directly to patients who get prescriptions by mail.

For a drink and some pointers where to visit along my route, I am quite happy to give advice to anyone!

Wednesday, August 12, 2009

My Road Trip South - in Miami Area

Hello from the road!

I'm still on my road trip south with my son (see My Road Trip South for map of the route).

We are currently in the Miami/Ft. Lauderdale area, where we will spend a few days before heading back north up the coast.

That's me resting during our 4-mile hike up and down the mountains in Shenandoah Park/Skyline Drive in Virginia a few days ago.

Some of the places we stopped at included Lancaster and Gettysburg, PA, Front Royal, VA, Charlotte, NC, Atlanta and Macon, GA, Tampa, St.Petersburg, Sarasota, and Lido Beach, Florida.

You can see all the pictures from my road trip on Flickr here.

I have Verizon Broadband access and have Tweeted and checked my email while my son is driving! But I haven't been keeping up with what's happening in the pharma marketing scene during the trip and probably won't be blogging too much for the next week or so. I hope you miss me, but wish me a great time on my awesome vacation with my son.

P.S. I am connecting with people in the areas I am traveling through and getting advice on what to see from my friends in Twitter. I may do a live podcast during my trip back up north. See you soon!

Friday, August 07, 2009

My Road Trip South

Starting Friday 7-AUG-2009, my son John -- who recently graduated from Penn State University (BS, Mechanical Engineering) -- and I will be taking a road trip south to Miami, Florida.

Our driving route to Miami and back to Newtown, PA is shown below. I hope to be updating this map during the trip and adding points of interest along the way with my comments (click on blue or other color markers to see my comments).

We expect to arrive in Miami on August 12th or 13th and leave on August 16, arriving back in PA on August 20, 2009. If you are located along our route, give me a shout out on Twitter (use hashtag #macktrip). Maybe I could stop by and say hello, or maybe you can tweet me some points of interest in your area. My Twitter handle is @pharmaguy.

I will be Tweeting during the road trip and may even find time to make a few posts to Pharma Marketing Blog.

View 2009 Road Trip South in a larger map

Wednesday, August 05, 2009

The New York Times, DTC, and Me

Several members of Congress are seeking restrictions on Direct-to-Consumer (DTC) pharmaceutical advertising (see "Just Say No to Drug Ads, Say Some Lawmakers").

Representative Henry Waxman (Democrat) wants to give FDA the power to "bar consumer advertisements for newly approved drugs until they have proved safe in real-world use," according to the New York Times. "Another Democrat, James P. Moran of Virginia is sponsoring a House bill that would ban ads for prescription sexual aids like Viagra and Levitra from prime-time television, on decency grounds."

In the past, even some prominent Republications expressed strong opinions against DTC ads (see, for example, "Deconstructing Frist on DTC").

The New York Times is joining in the "debate" over DTC advertising. In the past week, I have been quoted twice on the topic in the Times:
  1. In the New York Times Sunday Magazine article "Eyelash of the Beholder"
  2. In the New York Times Room for Debate OpEd Blog ("Should Prescription Drug Ads Be Reined In?")
In both cases, I argue that DTC ads--especially TV ads--play up the benefits while de-emphasizing the risks. This practice is especially unacceptable for drugs with limited health benefits such as Latisse and certain sleep aids.

For the record, I'd like to reproduce my contributions to these articles and add back a few things that were edited out or give you links to more details.

Here's how I was quoted in the "Eyelash of the Beholder" story:
John Mack, who publishes the e-newsletter Pharma Marketing News, notes that some critics of contemporary medicine complain of disease mongering -- the conversion of what used to be routine dissatisfactions of life into medical conditions, often treatable with drugs. But he agrees that Latisse, like Botox, makes no pretense of addressing a medical condition, just a cosmetic one. What he wonders about are consumers who hear “F.D.A. approved” as meaning “completely safe.” The ad mentions potential side effects like itching and redness and that if Latisse comes into regular contact with the eye there is “potential for increased brown iris pigmentation, which is likely permanent.” The latter had Mack somewhat jokingly fretting on his blog about whether Shields’s baby blues might turn brown. His real point: “Many people don’t read the side effects.”
Too bad the columnist, Rob Walker, couldn't use the title of my blog post, which got him interested in quoting me. That post was titled "Will Latisse Turn Brooke Shields' Blue Eyes Brown?" I hope you'll read it to get my complete views on that particular DTC campaign.

In the Room for Debate OpEd piece, I was allowed up to 400 words that were edited as follows:
The topic of direct-to-consumer advertising is a never-ending source of fodder for me, as well as other bloggers. I'm especially fond of those silly ads that feature dead presidents, beavers and bees. Very entertaining indeed, but are they educational? Not on your life!

Supporters of this type of advertising often cite the educational benefit it provides to potential patients. Indeed, a speaker at a recent industry conference raised the ante on the educational merit of these ads by suggesting that we “look abroad,” where there are no such ads, and “measure the health literacy to see the potential impact.”

I took the challenge, did some research and found a report that compared health literacy in the U.S. and in Canada. Canadians scored significantly higher than Americans.

Does this destroy the educational argument in support of direct-to-consumer advertising? Not necessarily. There is a difference between health literacy and being "educated" about a drug.

As for doing harm to consumers, I only need to quote the F.D.A.’s recently released "Draft Guidance on Presenting Risk Information in Prescription Drug and Medical Device Promotion," which states:
Consumers have preconceived ideas about the amount of scrutiny these ads undergo. Many believe F.D.A. exercises tight regulatory control over the content of these ads and to some extent, believe that all ads have been prereviewed prior to airing. As a result, consumers are likely to expect that the most relevant risks have been included in the ad.
I am not against prescription drug advertising, but it’s hard to defend it when the industry pushes the envelope by overstating benefits and playing down the risks. That has got to stop.
The Times did a good job editing and made me look smarter and less "snarky." But the edit did leave out the details of the study that compared health literacy in the US and Canada. You can find the details in the post "Health Literacy Worse Where There is DTC Advertising than Where There is No DTC!"

If you want to learn more about the FDA views on risk communication in DTC ads, see "Communicating Risk in Online Drug Ads: Reading the Tea Leaves in Recent FDA Draft Guidance."

What the NYT OpEd editor cut out of my piece was the following closing: "But, please, please, do not get rid of the bees, moths, and re-animated presidents. Without them, blogging about pharmaceutical marketing would be too boring!"

Was that too snarky?

Tuesday, August 04, 2009

Charlie Kimball, Novo Nordisk, and Me Make Up

Ever since I wrote my blog post dissing the first-ever pharma branded Tweet, people have wondered if I really have it in for the pharmaceutical industry. (start here and work your way back to catch up on the story).

Seems like no matter how "mean" I am, pharma people still come up to me at meetings to say hello and invite me to wine and dine with them. They even invite me into the tent to talk to their marketing people! Imagine that!

Today, I was invited to breakfast by Ambre Morley (@ambremorley), Associate Director of Product Communications at Novo Nordisk to meet Charlie Kimball -- the racecar driver and person with diabetes (PWD) who is sponsored by Novo Nordisk's Levemir insulin brand team.

Charlie was visiting Novo just a hop, skip, and a jump from where I live and work (Newtown, PA). So, we met. Why not? That's me and Charlie in the photo taken by Ambre just after our breakfast, which I think the restaurant deeply discounted because we were interrupted by a faulty fire alarm!

I had ordered what Charlie ordered: two eggs over easy with toast. I spread butter on my toast, Charlies favored jam. Butter is not good for my high cholesterol, but I know that PWD need to balance their sugar intake. In fact, Charlie has a special "feeder" strapped on to his helmet or seat when he races so he can drink orange juice through a tube as needed. It's just one way that he can do what he does although he has diabetes.

I think he mentioned that once on his personal Twitter page (@CharlieKimball), but may not have on his @racewithinsulin page. Charlie says the Tweets on both sites are written by him -- using his iPhone -- and are NOT edited by Novo as I had previously suggested. I did mentioned that more personal Tweets on @racewithinsulin would be welcome, especially Tweets about how he deals with diabetes as a racecar driver.

Charlie depends on his sponsorships to keep his career going, just like any other racecar driver. He wants to make sure he does a good job for Novo in representing the Levemir brand. Although Novo does not tell him what to Tweet nor does Novo edited his Tweets, Charlie has been briefed on how to word his Tweets whenever he mentions a Novo branded product.

Ambre and I discussed some of the hurdles that pharmaceutical companies face when using Twitter and other social media applications. Two takeaways from that discussion were:
  1. It would be much easier if FDA came out with guidelines for how pharma can use social media without getting into regulatory hot water, and
  2. Because of "one size fits all media" FDA regulations, Twitter has limited potential for pharma because it cannot be customized to help pharma comply with those outdated regulations.
As for point 1, IMHO, FDA can not long hide behind the "It's the message, not the medium" defense much longer. Clearly, there are limitations associated with Twitter that cry out for a special case just like FDA made a special case for TV ads (called the "brief summary'). I suppose, however, that it is unrealistic for FDA to carve out special exceptions for Twitter like it did for TV. Unrealistic until Twitter supports as big an economy as TV does -- I don't know anyone who makes millions producing Twitter commercials, do you?

Let's discuss Levemir branded Tweets. Why can't these Tweets link to useful information for PWD instead of the technical Prescribing Information (PI)?

Here's how Novo sees it: Every branded Tweet MUST be just one-click away from the PI because the Tweet exists on the Race with Insulin page that mentions the benefit. Even though there is amble fair balance on that page, FDA expects a direct link to the PI also. Unfortunately, Twitter does not allow users to put links like that on the background. Such a capability would be one way that Twitter could help pharma. Unfortunately, when pharma explains FDA requirements to the Twits at Twitter, all they can say is "What's an FDA?"


Anyway, thanks Ambre and Charlie for meeting with me. Hopefully, we can followup with an Pharma Marketing Talk live interview/podcast soon. Meanwhile, you can follow some more of my breakfast encounter with Charlie via Twitter by searching for the #ckbkft hashtag (or just click here).
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