Competitors Are "Best Source" of Complaints About Promotions Received by FDA

Approximately 12 minutes into yesterday's 45-minute "Bad Ad Program Webinar," Catherine Gray, PharmD, Management Advisor at DDMAC, got down to business and started talking about the program that some critics have said is "ineffective, not cost-effective, and biased" (see poll here). At that point, Gray talked about "Limitations" of FDA's drug promotion surveillance. She focused on promotions to physicians.

Among FDA's TOP three "normal" surveillance activities was "complaints submitted by industry competitors." In fact, Gray said "we have found that industry competitors tend to be some of the best sources of information about potentially false and misleading advertising."

I am not surprised that competitors complain to the FDA. I've spoken to industry people who read this blog because they like to see me blast their competitors. For example, when I speculated that Phil Mickelson was on the AMGEN/PFIZER payroll when he said glowing things about ENBREL in the press (see "Is Phil Mickelson Shilling for Enbrel?"), a competitor told me that his company wondered the same thing.

Of course, even competitors cannot hear what's said "behind closed doors" in physician offices, industry-sponsored dinner and lunch programs, and on the floor at major medical meetings. The FDA initiated its BadAd program to "fill these gaps" in its surveillance activities. Thus, the BadAd program is designed to solicit complaints from physicians about verbal statements made by company sales reps or company-paid speakers.

When asked "In cases where there is a complaint about an oral statement, what evidence standard do you use to go forward with an action," an FDA speaker responded: "We have a very high level of evidence that we require that often includes an affidavit ... and verification as well. So, we do have a very high ... standard of evidence that we require before taking enforcement action." No further details were given.

However, in response to another question, FDA said they also accept anonymous complaints, which obviously cannot be substantiated by an "affidavit." FDA does not reveal how many of the 239 BadAd complaints it received in 2010 were from "anonymous" sources, but given the fact that competitors are likely to be a major source of complaints, I image that a good deal of BadAd complaints are anonymous and likely to be worthless.

Of course, some companies are just too dumb not to leave a trail of verifiable evidence, such as Hill Dermaceuticals, which had a nice public website the FDA could plainly see violated its regulations (see FDA's Bad Ad Program is "Phoniest Thing Ever!" and screen shot below).

No wonder then that the Hill Dermaceuticals case was the ONLY BadAd complaint that resulted in a notice of violation letter. Does the FDA need a BadAd program for that? BTW, Jerry Roth, president of Hill Dermaceuticals, complained that DDMAC acted on a complaint filed by "a doctor for another [competing] company." Mr. Roth should THANK the FDA for giving his company some GREAT promotion!

Aside from violative verbal statements, the FDA's BadAd program is designed to capture complaints specifically about "Home-made promotional materials not submitted to FDA."

How rampant is the use of "home-made promotional materials" by pharma sales reps? It must be significant if the FDA specifically mentions it as a reason for the BadAd program, which don't forget, was created by "2 former sales representatives with 11 years combined selling experience." These former reps, said Gray, "are well aware what goes on behind closed doors." Perhaps these two former reps engaged in questionable promotion to physicians themselves? Gray added that they were "quite successful in selling their products."

My impression of the BadAd program is that it was created by former drug industry sales professionals and is designed to make it easier for sales reps and company-paid physicians to "rat out" their competitors, anonymously or not. It just doesn't present a good image of how a government agency should work. In fact, I am sure that under a new administration, the BadAd program will be the first item on the agenda for cutting. While it may be easy these days for a drug rep to begin a career in the FDA, I am not so sure a former drug rep FDA staffer will be able to get a job in the drug industry after being laid off due to budget cuts!

FDA's Proposed Web Study Will Further Delay Social Media Guidelines

FDA has published in the Federal Register (click here) a series of proposed studies designed to test different ways of presenting prescription drug risk and benefit information on branded drug Web sites.

This is BAD news for all us who have been waiting since November 2009 for the FDA to issues specific guidelines for use of the Internet and social media in promoting Rx drugs.

In its proposal (find my highlighted, annotated pdf version here), the FDA states:
"This research is relevant to current policy questions and debate and will complement qualitative research we plan to conduct on issues surrounding social media. The original regulations that presently determine FDA’s position on DTC promotion were written at a time when the available media for DTC promotion were print and broadcast, and the primary audience was health care professionals. This dynamic is shifting, and evidence is needed to support guidance development [my emphasis]."
While it's interesting that the FDA now admits original regulations are not adequate in the "shifting dynamic" of today's Internet communication channels, FDA is essentially TABLING Internet guidance by proposing these studies. It's a classic bureaucratic delaying maneuver!

The first leg of the delay will be the 60 days beginning today necessary for the FDA to collect comments to its proposal via the Federal Register page linked to above. Then, FDA will have to review all comments regarding this proposal. Then, if FDA is not seriously challenged on the need for such studies (IS THERE REALLY A NEED?), it will implement the studies. After that it may or may not publish the results of the studies and Tom Abrams will go around the industry conference circuit presenting the results of the study while promising "to have these guidances out as soon as possible."

To which I say BULLSH*T!

Enough studies and hearings already!

I urge all who are interested to submit comments to the docket (here) and tell the FDA that these studies are NOT needed and that it should get off its ass and provide the industry with useful guidance.

P.S. Also, tell FDA it's time for Abrams to retire! (see "Is It Time for Abrams to Leave?").

YouTube Interruptus! Dear WhyInsulin: WHY the Dreadful LANTUS Safety Information Blue Screen and Voiceover?

DigiatlBulldog just tweeted this: "Breaking News: GoInsulin's YouTube replacement WhyInsulin is now live http://bit.ly/eDX0cT #socpharm"

The WhyInsulin Youtube Channel seems to be Sanofi-Aventis' latest venture into social media. Importantly, the site allows visitors to submit comments, which is rarely something pharma companies do.

I submitted this comment, which is "pending approval":

"Why was Shenee's video interrupted by the reading of the LANTUS safety information?"

What I was referring to was a dreadful blue screen and voiceover segment that abruptly ended Shenee's story. "Shenee is an active wife and mother who enjoys bowling, fishing, reading and cooking exotic foods with her husband." The blue screen, which began 55 seconds into the 3.04 minute video, merely showed a still text image (no scrolling or any movement at all) while a voiceover read the "Important Safety Information for Lantus" that was displayed on the YouTube page (see below).

I never did get to see what exotic foods Shenee was preparing! The blue screen completely took over the last 2 minutes and 9 seconds of the video!

The surprising thing is that Shenee NEVER mentioned LANTUS or any other treatment during her brief 55 second "story"! Which leads me to ask, Why was it necessary to interrupt her story with this information?

It just runied my whole experience with the site. I gave it a thumbs down. So far, there are 2 thumbs up and 2 thumbs down. What do you think?

Who Regulates Press Releases? The Case of Bayer's "Melt-in-Your-Mouth" Erectile Dysfunction Tweet

Digital Pharma caught Bayer posting a Tweet - via its @BayerUKIreland Twitter account - that seems to violate new social media guidelines published by the UK's Prescription Medicines Code of Practice Authority (PMCPA), which oversees the self-regulatory code of the Association of the British Pharmaceutical Industry (ABPI).

Here's the Tweet stream that Digital Pharma preserved:

The tweet in question states "First and only melt-in-the-mouth erectile dysfunction (ED) treatment launches in the UK today." It includes a link to a LEVITRA BRANDED press release. I have preserved the press release as a PDF version (here) of the original Web version. I did this because Bayer might remove the original after it reads this post.

The PMCPA code states: "If a company wanted to promote a medicine via twitter it would have to ensure that if the medicine was prescription only, the audience was restricted to health professionals and that the message, in addition to any link to further information, complied with the Code. In addition companies would also have to ensure that recipients had agreed to receive the information. Given these restrictions and the character limit on twitter, it is highly unlikely that the use of this medium to promote prescription only medicines would meet the requirements of the Code. Using twitter to alert health professionals about the publication of a study on a medicine is likely to be considered promotion of that medicine."

As Digital Pharma points out, tweets are viewable by the general public and therefore cannot be "restricted to health professionals" as required by the PMCPA code: "The @BayerUKIreland account has about 500 followers, some are clearly members of the public, but many show no information as to followers’ location or occupation. As an open account all its tweets are on public display and indexed by search engines like Google."

BTW, I could NOT find the tweet by searching Google OR by examining the @BayerUKIreland Twitter stream. That's because Bayer DELETED the tweet according to Digital Pharma. This immediately raised red flags.

But does the Bayer tweet violate the PCMPA code?

In a previous post (see "Brits Beat FDA & PhRMA: Issue Social Media Guidance for Pharma. This BI Tweet May Not Pass Muster") I pointed out that Tweets such as the following from Boehringer Ingelheim (BI) may violate the PMCPA code:

The BI tweet mentions a BRAND name and its indication, but does not include fair balance information. The Bayer tweet, however, does NOT mention a brand name, just the indication and a benefit of a treatment (ie, "dissolves in the mouth in seconds, there’s no need to take it with water and it’s discreet").

Although the Bayer tweet does not mention a brand name, it may still be considered promotion of a drug in the UK. If so, does it violate the PMCPA code? According to Bayer, "Despite the recent publication of a discussion paper from the PMCPA, the position on use of social media and digital communication in relation to prescription medicines remains far from clear."

Bayer's Unregulated Press Release Posted via Twitter is NOT Balanced
Another issue that is FAR FROM CLEAR to me is how the Bayer PRESS RELEASE can pass regulatory muster in the UK. According to Digital Pharma, Andrea Postles (@AndreaPJPostles, LinkedIn public profile), PR & Media Relations Manager at Bayer UK, said: “We have sometimes ‘tweeted’ approved news releases where we know that the content, while of interest, is nevertheless non-promotional, and contains only factual and balanced information."

To which I say BULLSH*T! You can read the "approved" press release here. It is clearly NOT "non-promotional" as Ms. Postles claims.

For example, the first paragraph of the press release states: "Today marks the launch of the first ED treatment available as an orodispersible tablet. In contrast to other drugs of the same class, the new formulation has been designed specifically to be discreet and convenient, has a minty flavour and dissolves on the tongue within seconds."

Here's another example of promotional language found in the second paragraph of the press release: "Levitra orodispersible was developed to help remove the known barriers associated with erectile dysfunction medication by providing men with a more convenient and discreet treatment option which may also help to lessen the embarrassment surrounding the condition."

I'm sold! Where do I get it?

OK, so the press release IS promotional. It mentions the brand name and benefits. But shouldn't it also mention possible side effects and safety information -- ie, the fair balance? Contrary to what Ms. Postles says, the press release does NOT contain "balanced information." There is NO mention of any possible side effects, other treatment options, risks, etc. It's all about LEVITRA and its benefits.

Most pharma product-specific press releases I have seen have a section entitled something like "IMPORTANT SAFETY INFORMATION." The Bayer press release has NO such section. How can it be called balanced?

The importance of PR as a marketing tool has increased DRAMATICALLY, IMHO, with the ascendancy of Twitter and other social media applications.  Pharma corporate communications people seem to be taking a leading role in using social media to promote products while claiming what they do is NOT marketing or promotional. This is a hot topic that I will explore with colleagues in tonight's #socpharm chat at 8 PM Eastern. Join us!

P.S. @Alex__Butler tweeted this: "@pharmaguy on the broad point of press materials they are public and covered by the code/clause 22; http://t.co/U9FM6UC" which links to the 2011 version of the ABPI Code of Practice for the Pharmaceutical Industry (here). Clause 22.2 states:
"Information about prescription only medicines which is made available to the public either directly or indirectly [my emphasis] must be factual and presented in a balanced way. It must not raise unfounded hopes of successful treatment or be misleading with respect to the safety of the product.

"Statements must not be made for the purpose of encouraging members of the public to ask their health professional to prescribe a specific prescription only medicine."
A press release is information that is intended for journalists with the intent that they will write a story about the information in the press release. Thus, the Bayer press release was made available "indirectly" to the public -- and even directly because of the Tweet linking to the press release.

The press release is "misleading about the safety of the product" because it contains NO SAFETY INFORMATION whatsoever!

Although the press release does NOT directly "encourage members of the public to ask their health professional to prescribe a specific prescription only medicine," the benefit statements made in the press release are simple for the average Joe (or Nigel) to understand and certainly aim to encourage the public to get a prescription of this product.

FDA Plans to Test New Standard for Easy to Understand Rx Labels

Every Rx drug is supposed to include an FDA-approved "package insert" (PI) that provides information about the drug, including instructions for taking the drug and warnings about interactions and side effects. Most official PI's, however, are pretty technical and difficult to read, especially by seniors who may have problems reading the small type.

Besides being difficult to read, the official PI often is NOT included with your prescription -- the pharmacy asks you to sign a sheet, however, that indicates you have been informed about the drug. Thus, they don't need to give you the PI unless you specifically ask for it.

In an effort to make PI's easier to read and understand -- and perhaps to save money on printing costs -- the FDA is "planning to test single-page consumer information sheets that would replace the multi-page package inserts and medication guides widely used in retail pharmacies," according to this story in the Wall Street Journal. According to the WSJ:
Michael Wolf, an associate professor at Northwestern University's Feinberg School of Medicine who serves on an FDA risk-communication advisory panel, says in recent studies, more than half of adults misunderstood one or more common prescription warnings and precautions. In one study Dr. Wolf and colleagues found that patients better understood simple, explicit language on warning labels—like "use only on your skin" instead of "for external use only"—and those with lower literacy skills also benefited from picture icons, such as a sun with a black bar across with words, "limit your time in the sun."
Proposed labeling changes would look like this:

Not only are these changes simpler and easier to read, the icons are more grounded in the culture of the "common man." The current icon for DO NOT DRINK uses a martini glass including an olive (or is it a more upscale onion?). The new proposed icon uses what appears to be a wine glass. Perhaps an even better choice would have been a can of beer?

However "dumbed down" the label gets, it is still important that physicians and pharmacists take a more pro-active role in educating consumers about the drugs they are taking.
"Doctors and pharmacists are also being encouraged to counsel patients more effectively about their medications," reports the WSJ. "About 100 industry and nonprofit groups are participating in a national awareness campaign about the importance of taking medication as directed, to be launched in May by the National Consumers League. The campaign includes a website for health professionals and a separate website where consumers can download tools such as work sheets to manage their medications. The group says more than a third of medication-related hospital admissions are linked to poor medication adherence."
Patient Behavioral Coaching Podcast
Pharmacists have been recognized as a vital part of the patient support team and play an important role in offering patient care and health behavior change services that help increase patient access to healthcare and improve the quality of care.

This Thursday (April 28, 2011; 2 PM Eastern US) I will have a live online conversation with Stacey Irving, Senior Director, Channel Marketing, and Derek Rago, VP Marketing & Strategy, at McKesson Patient Relationship Solutions, about the McKesson Pharmacy Intervention Program, which expands patient access to one-on-one behavioral coaching about the importance of taking medicines from retail pharmacists in the McKesson network.

You can listen to the live interview here or to the audio podcast afterward here.

I will also be the guest moderator for the #socpharm Wednesday night Twitter chat, the focus of which will be patient adherence (8 PM Eastern US). Find more information about #socpharm here.

Proof That Pharma Marketing Works: Lovaza sold more than $1 B in 2010!

When marketing alone -- not the merits of the product being marketed -- creates a Billion Dollar market, that's PROOF that marketing works!

The product I am talking about is LOVAZA, of which GSK sold more than $1 Bn worth in 2010 according to The Pink Sheet Daily!

Back in January 2010, I cited LOVAZA as an example of the sorry state of drug industry innovation because it was nothing more innovative than what you can buy over the counter in any drug store (see "Drug Industry Innovation: GSK's LOVAZA Vs. OTC Omega-3 Fatty Acid Supplements").

I guess GSK is laughing at me all the way to the bank!

Of course, GSK can thank the daily TV ads aired during the evening news for much of this success. But physicians must be persuaded to prescribe the pills and insurance companies must be persuaded to cover the cost. How'd they do that?

There are more LOVAZA-like fish in the high triglyceride sea coming soon. Other companies are developing their own versions of LOVAZA to cash in on this cash cow.

Getting the raw fish oil will NOT be a problem -- even if Japan is taken out of the equation due to radioactive contamination. "There are millions of tons of fish oil out there," said an executive. Not much of it, however, will come from American fisherman -- "70% to 90% of the supplies are harvested in Chili and Peru."

FDA's Bad Ad Program is "Phoniest Thing Ever!"

So says Jerry Roth, president of Sanford, Fla.-based Hill Dermaceuticals. His company received the ONLY letter from the FDA as as a result of a complaint received via DDMAC's (Division of Drug Marketing, Advertising, and Communication) Bad Ad Program (see here).

According to Advertising Age, FDA received 239 complaints to the Bad Ad program from its launch in May through January of this year. "Of these complaints, 129 (54%) have come from health-care providers, 73 (31%) from consumers, and the remainder from other sources. Of the 239 complaints, approximately 135 were deemed to have sufficient merit for further investigation, with approximately 50% falling within DDMAC oversight and the rest being referred to other centers within FDA."

According to DrugWonk's Peter Pitt, "At best this effort isn’t, um, cost effective" (see here).

I myself submitted a compliant to the FDA regarding this Lyrica DTC Ad. I didn't get any response from the FDA due to this "technical glitch" in the auto-response to submissions to its BadAd program. The belated response came from "Bob Dean," the lead consumer safety officer for DDMAC. Dean worked as Senior Specialty Sales Representative at Johnson and Johnson for five years and as a Sales representative at UCB for 2 years (see his LinkedIn profile).

Mr Roth claims DDMAC acted on a complaint filed by "a doctor for another [competing] company," which is interesting. The FDA solicited complaints from doctors because "prescriber[s] can play an important role in ensuring that prescription drug advertising and promotion is truthful by recognizing and reporting misleading drug advertising and promotion." But because so many -- perhaps up to 80% of -- "prescribers" are employed directly or indirectly by pharmaceutical companies, the Bad Ad program is open to criticisms similar to Mr Roth's.

Roth also said "I sell my products at around $50 a prescription when the average prescription is near $200. So you figure out why they came after me." Given Mr. Dean's background in Big Pharma, I can feel Mr. Roth's pain!

The letter Hill Dermaceuticals received cited that certain pages on the company's website were "false or misleading because they omit and minimize the risks associated with the use of Derma-Smoothe Body Oil, overstate its efficacy, present unsubstantiated superiority claims, broaden and inadequately communicate the indication, and present unsubstantiated claims for the drug product." This is interesting because that's EXACTLY what I said about Pfizer's Lyrica DTC Ad!

The question is, Is FDA's Bad Ad program biased, ineffective, not cost effective, or all of the above? Take my little survey and tell me what you think.

Do you think FDA's Bad Ad Program is:
Not worth the cost
All of the above
None of the above


P.S. FDA is hosting a Bad Ads Program webinar titled, "An Overview of the FDA’s Bad Ad Program," on Thursday, at 12 Noon (ET), April 28, 2011 (see here). Catherine Gray, Pharm.D., will present an overview of the FDA’s "Bad Ad" program, specifically focusing on how to identify misleading prescription drug promotion and report this activity to the agency.

A New Estimate of Drug Development Cost

I have tackled the estimated $800 million drug develop cost gorilla before and garnered a lot of comments from readers, including Dr. Joseph DiMasi, whose team came up with that number way back in 2003. Since then, the number has been adjusted upward to over $1 Billion due to inflation/increased costs.

In his comments to me -- see "Tufts Hangs Tough on Opportunity Cost Analysis" -- DiMasi said "You write that [my] study is disputed. That's true, but, as far as I can see, the ultimate sources of that criticism are those with obvious political agendas and who lack appropriate expertise. I have never seen a criticism of the methodology from a bona fide economist."

Now comes a NEW estimate from someone who HAS the appropriate expertise, if by "appropriate" DiMasi meant someone who has has a PhD in economics. That person is Rebecca Warburton. She is the co-author of a recent paper published in Biosciences entitled "Demythologizing the high costs of pharmaceutical research" (BioSocieties 6, 34-50; March 2011). The lead author is Donald Light, an economic and organizational sociologist. He is also a visiting professor at Stanford University and a professor of comparative health-care at the University of Medicine and Dentistry of New Jersey.

Light and Warburton's NEW estimate for the MEDIAN cost to develop a new drug is $59.4 million, which is more than an order of magnitude LESS than the DiMasi estimate. To emphasize this difference, I created the following chart (I love charts!):

I labelled the new estimate "LSEPS" in honor of the London School of Economics and Political Science, which published the paper. SO we have two estimates from two schools -- DiMasi's estimate is most often referred to as the Tufts estimate.

How is it that the Tufts estimate is at least 14 TIMES the LSEPS estimate? Well, you'll have to read the LSEPS paper to find out or wait until I can get the authors to be a guest on my Pharma Marketing Talk show.

But Light and Warburton claim that the Tufts estimate is based on a biased sample of drugs and drug firm data, that R and D costs were ‘padded’ with legal and other nonresearch costs, included poorly documented preclinical costs, overestimated trial costs and sizes, and exaggerated risks of failure.

Like Derek Lowe, you may believe that the LSEPS paper is "a case for the prosecution, not a dispassionate analysis" and "attempt to replace one shaky number with another" (see "The Costs of Drug Research: Beginning a Rebuttal").

But Light and Warburton do make several interesting criticisms of the Tufts analysis, including debunking the infamous $400 million "Cost of Capital" estimate, which is a long-standing point of contention between DiMasi and his critics.

Simply stated, the cost of capital is the loss of returns from funds that would have been invested in the stock market, were the R and D project not undertaken. DiMasi used an estimated ‘cost of capital’ of 11 per cent, based on equity returns between 1985 and 2000. "Even if one were to accept the argument that profits foregone should be included as a ‘cost’, US government guidelines call for using 3 per cent, not the 11 per cent used by DiMasi and colleagues," said Light and Warbuton. NOTE: the $59.4 million LSEPS estimate includes a modest cost of capital allowance (about $16 million); without that, the NEW estimate is $43.4 million, about 1/18 what Tufts estimates.

I can't get cover all the criticisms Light and Warburton have of the $802 million Tufts gorilla. I suggest you read Derek's blog post (op cit) as well as this Science-based Medicine blog post: "What does a new drug cost?"

ADDENDUM: Tufts/DeMasi Responds
I was informed that Tufts/DiMasi responded to the Light and Warburton publication. Find that response here. An excerpt:
"In their commentary, Light and Warburton restate arguments about the methods and data used for our R&D cost study that they have had published elsewhere. We have thoroughly rebutted each and every one of their prior claims in two published responses that Light and Warburton do not cite in their current paper (DiMasi et al., 2005a, 2005b). In the current piece, Light and Warburton also attempt to operationalize their criticisms by making adjustments to our published estimates that purport to demonstrate that R&D costs are much lower than we estimated. They make five such adjustments, all of which are erroneous --- they inappropriately mix median values reported for individual drugs with what are mean values for the costs of clinical failures and preclinical fixed costs, and for which the concept of a median has no meaning; they misconstrue the nature of the corporate income tax and incorrectly consider manufacturing tax credits; they use discount rates that are meant for other contexts but that are inappropriate here; they treat line extension approvals as separate and independent units of observation alongside their original approvals; and they grossly misstate the meaning of and misuse figures in our paper on industry-reported data on expenditures on self-originated drugs, licensed-in drugs, and already-approved drugs. Detailed discussions of these issues can be found in our above-mentioned rebuttals. In short, every one of Light and Warbuton's adjustments are invalid. Furthermore, two peer-reviewed papers by current and former FTC economists, also not cited by Light and Warburton, validate our work using other methods and public data (Adams and Brantner, 2006, 2010). They find that R&D costs are likely as high or higher than our estimates."
- Joseph DiMasi, Ph.D.
The ending paragraph of the response reads more like the defense of a besieged fort than of an academic study:
"Make no mistake: While we are more than willing to engage in a productive discussion about research methodology and interpretation, Tufts CSDD will vigorously defend the scholarship, integrity, and validity of all its published research studies [their emphasis]. As noted above, we have addressed Light and Warburton’s criticisms of our cost study in the past. Going forward, we will continue to defend the study against these authors and others who attempt to denigrate the validity of its findings."

For a followup, see "Drug Industry "Dirty Tricks Part 2: R&D Costs".

Republicans Favor Government Health Care Coverage When It Benefits Them; Ie, When They Get Old!

Results from the latest New York Times/CBS News poll conducted April 15-20 with 1,224 adults nationwide indicate that only 25% of Republicans think providing health care coverage to the poor is the responsibility of the federal government, whereas TWICE as many (55%) believe the federal government should provide health care coverage to the elderly. Meanwhile, 73% of Democrats, favor federal health care coverage for the poor. If only there was an American Association of Poor People (AAPP)!

Did Boehringer Mishandle This Adverse Event Report on Twitter?

I follow many pharmaceutical companies (and employees of pharma companies; eg, these people) on Twitter. @BoehringerUS is one of them. To keep track of these accounts, I cross-post the tweets to this Pharma Marketing Forum (News Direct from the Pharmaceutical Industry), which automatically sends me a daily email message telling me what's been posted there. It's a good way for me to filter through all the tweets from the over 2,500 people I follow on Twitter.

Today, I received notice of the following tweet from @BoehringerUS:
@professorbunbun Please call Boehringer Ingelheim @ 800-542-6257 option 4 to report adverse events or product complaints.
I traced back the Tweet timeline of @professorbunbun -- "Meredith: Just a girl trying to aclimate to the 21st century corporate world after three years as Betsy Ross in 1776." -- to find the tweet that triggered that reply from @BoehgingerUS:
Also @boehringerus your drugs, (Mirapex,) didn't work and made my mom's hair fall out so that is a double-strike as far as I am concerned.
Here it is in context via Twitter:

Does this tweet by @professorbunbun satisfy FDA's four criteria for a REPORTABLE adverse event (AE), namely:
  1. An identifiable patient - Meredith's mom
  2. And identifiable reporter - Meredith
  3. A suspect drug, biological product, or device - Mirapex
  4. An adverse event or fatal outcome - hair loss
The second criterion -- identifiable reporter -- is the problem. We don't know the true identity of "Meredith."

So, Boehringer did not have enough data to issue a report to the FDA, which has not (yet) issued any guidelines on what constitutes an "identifiable reporter" on social media. For more on that topic, see "Uncertainties Regarding Reporting Adverse Events Found on Social Media Sites."

Instead of telling @professorbunbun to call an 800 number and press "4" to report the adverse event, @BoehringerUS could have been more proactive and asked Meredith to identify herself so that an AER (adverse event report) could be made to the FDA. However, it would not have been a good idea to ask Meredith to reveal her identity via a public reply on Twitter. @BoehringerUS, however, could have sent @professorbunbun a direct message (DM), which is NOT public and Meredith could have DM'd a reply. But that would require @professorbunbun to be a Twitter "follower" of @BoehringerUS and vice versa. It's not likely they follow each other, although the two parties could have agreed to do so.

All this, however, is probably not the job of the people behind @BoehrinerUS, who are mostly public relations/corporate communications people -- although I believe AEs SHOULD be their concern (see "Adverse Event Reporting -- Pharma Puts Profits Before Patients. A Missed Opportunity"). Hence, the tweet telling @professorbunbun to call the 800 number.

Making a public announcement via Twitter on who to contact to report an adverse event is probably a good idea. Perhaps pharma companies should make such tweets from time to time even if they are not responding to a potential reportable AE tweet.

But I question the use of an 800 number in this age of technology, especailly when you are communicating with technically savvy people who use Twitter! Why doesn't Boehringer -- and other pharma companies -- have a more convenient online mechanism for reporting adverse events DIRECTLY to the FDA as I suggested in this post: "Tit-for-Tat Tithe on Pharma Marketing. How It Can Work."

BTW, the AE exchange between @professorbunbun and @BoehringerUS began almost as an after thought prompted by a different sort of adverse event suffered by Meredith herself: the failure of a Boehringer "resistance band" at the Parkinson's Unity Walk (Boehringer was a Diamond Sponsor). Here's @professorbunbun's tweet about THAT adverse event:
Also, @boehringerus next time you hand out resistance bands at @unitywalk it might be a good idea to make sure they don't snap at first use

Is the Nasonex Bee on Twitter? Or Is This an Impostor?

A couple of years ago, I suggested that pharmaceutical companies can leverage their brands' assets via Twitter by launching brand mascot accounts. I predicted, for example, that the Nasonex bee character would start "Tweeting like a little bird" (see "Nasonex Bee May Usher In a Whole New Way to do FDA-friendly Pharma Tweets").

I did a Twitter search for "nasonex" and discovered that there is indeed a @Nasonex_Bee Twitter account that describes the fun-loving mascot this way: "Flying around pushing overpriced prescription meds, and showing up on your TV screen in obnoxious commercials far more often than you can actually tolerate me." Below is the screen shot of the account's twitter home page:

Obviously, this is a fake Twitter account.

Brand mascot impostors are rampant on Twitter according to Advertising Age (see "Twitter Identity Theft Strikes Brand Mascots"). "Many of the most-loved brand mascots, from the Pillsbury Doughboy to Tony the Tiger, are on Twitter in some respects, but not in any official capacity," notes AdAge. "Everyday people not affiliated with the brands have picked up those familiar names and cartoon faces, as many marketers have left them idle. @TheChefBoyardee, for example, is foul-mouthed, wears a chef's hat and applied to Charlie Sheen's #tigerblood internship."

The @Nasonex_Bee Twitter account is locked/protected -- you can't follow or see its tweets without first sending a request to do so, which I did (no answer yet). The account has only 1 follower.

It seems that the Packaged Goods industry is not doing a good job protecting their brand assets and neither is the pharmaceutical industry.

If you know of any fake or real pharma brand mascot Twitter accounts, please let me know.

Pharma Even More Digitally Feeble When it Comes to Healthcare Providers!

"More than 60 percent of brands’ HCP digital efforts result in Challenged or Feeble Digital IQs," according a new Digital IQ INDEX® ranking created by think tank L2 in partnership with Vue Group. The results are shown in the following chart:

This is in stark contrast to the May 2010 Digital IQ Index™ for Pharmaceuticals that analyzed direct-to-consumer (DTC) digital efforts. That analysis found that 31 percent of brands were digitally "Challenged"o r Feeble" (see "Is Your Brand a Digital Genius or a Feeble-Minded Idiot?").

The report also concludes that "most brands are not purchasing HCP-targeted search terms, investing in mobile, engaging in email marketing, or investing in display advertising on physician portal sites." For more information, including a table of IQ scores for 70 brands, download the report here.

The report laments the limited investment and adoption of digital technology to reach physicians and provide them product information on-demand and on their own schedule. For a A Lilly case study on reaching physicians via the Web, see this Pharma marketing News article: "Pharma TeleWeb e-Detailing" (use code 'TWEB' to download it free).

(Little) Used Drug for Sale. GSK Says, Bye Bye Alli!

"Four years after launching the nonprescription diet pill Alli with much fanfare and a heavy marketing budget, U.K. drug maker GlaxoSmithKline PLC (GSK) on Thursday said that it plans to sell off the drug," according to this story in today's WSJ.

Back in November, 2010, I noted that the EU would release data in December that could put Alli diet pill sales in the toilet (see here). GSK "acknowledged in February that demand for the drug was falling in the U.S. and Europe."


GSK sold £150 million of Alli in 2007, £75 million in 2009, and £203 million in 2009 as GSK launched Alli throughout Europe. GSK didn't break out Alli sales in 2010, but I bet it's back down to £100 million level. Not exactly in the toilet yet.

I can't wait to see who buys this lemon.


Public Citizen Asks FDA To Remove Two Diet Drugs From The Market.
ABC World News reported, "You've probably seen the ads for that diet pill Alli [orlistat] that promises safe weight loss without starving yourself. Forty million people have tried it or its prescription alternative Xenical, but complaints of nasty and dangerous side effects are increasing and for the second time in five years health advocates urged the government to ban it."

The AP reports that "Public Citizen filed a petition with the FDA on Thursday calling on the agency to remove" both drugs "from the market." The group "says it identified 47 cases of acute pancreatitis and 73 kidney stones among patients taking the drugs. The reports were culled from the FDA's public database of negative drug reactions."

New Research Links Orlistat To Increased Risk Of Acute Kidney Injury. 
HeartWire reported that "a review of patients taking the diet drug orlistat (Xenical/Alli, Roche) in Ontario, Canada over a seven-year period points to a 2% increase in acute kidney injuries within one year of patients starting the drug." The data "were reported by Dr. Matthew Weir (University of Western Ontario, London) and colleagues in a research letter published April 12, 2011 in the Archives of Internal Medicine."

Ad Dollars Follow Eyeballs to Web

Internet advertising revenue in the United States totaled $26.0 billion for the full year of 2010, whereas ad revenue earned by newspapers was $22.8 billion, according to a PwC/IAB report (see here). Here's the distribution of ad revenue charted by category:

Here's the trend in annual Web ad revenue from 2000 through 2010:

Search continues to get the largest share of online revenue, although this share decreased to 46% in 2010 from 47% in 2009. Still, search revenue totaled $12.0 billion in 2010, up over 12% from $10.7 billion in 2009. Display-related advertising revenues -- which includes revenue from display banners, rich media, digital video, and sponsorships -- totaled $9.9 billion or 38% percent of 2010 revenues, up 24% from the $8.0 billion reported in 2009. Digital video ad revenue accounts for 5% ($1.4 billion) of the total Web ad revenue.

From these data, you might assume that the drug industry spends 25% of its ad dollars on Web advertising. That could be a false assumption. It's generally believed that the drug industry Web advertising slice of total ad spend is much less than 25%.

Finally, according to PwC/IAB, here's the percent of total Internet ad revenues from different industries:

GUESSTIMATING Total Pharma Web Ad Spending
Pharma & Healthcare are near the bottom of this chart. 5% of $26.0 billion is $1.3 billion, which is what the Pharma/Healthcare industry spends on Internet advertising (INCLUDING search) according to PwC/IAB. Let's say 80% (ie, $1 billion) of that is Pharma-related. Pharma spends about $4.5 billion in direct-to-consumer advertising. It may spend the same in advertising to physicians -- not counting samples and sales rep expenses. If my guesstimate is correct, then $1 billion accounts for about 11% of the total pharma ad spend.

Phil Mickelson is Now Regulated by FDA

Recall that last summer Phil Mickelson was quoted in the press as saying he was treating his Psoriatic Arthritis with ENBREL. He was also quoted as saying: "I have no aches and pains. My back feels great. I feel stronger and more flexible than I've ever been" (see here).

At that time, Phil may or may not have been in talks with AMGEN/PFIZER to sign on as a celebrity spokesperson, but the simultaneous appearance of multiple news stories featuring Phil & ENBREL sure looked like an audition to show AMGEN/PFIZER what he could do for them.

During last week's 2011 Masters Tournament, Phil finished tied for 27th place! Consequently, I didn't see much of him on TV hitting a golf ball. I did, however, see a lot of him on TV ads for ENBREL. Now that he is featured in ENBREL TV ads, everyone knows he is a paid spokesperson. I have no problem with that, especially that now his commercial speech is regulated by the FDA and he can no longer make outlandish statements such as the one above.

Instead, the best he can now say is "I'm surprised how quickly my symptoms have been managed" (watch the commercial here). Also included is all the scary side effects of this drug, which Phil didn't mention in his media interviews BEFORE becoming a paid spokesperson.

Obviously, ENBREL didn't help his game in last week's Masters.

BTW, I DID see Phil hitting golf balls on TV last week! But it was in an ENBREL ad! I noticed in that ad that Phil misses a chip shot! What's up with that? Seems to add insult to injury.

Maybe if the ad showed him getting the ball in the hole from the rough, the FDA might have sent AMGEN/PFIZER a letter complaining that this could be interpreted as overstating the benefits of ENBREL.

Actually, Phil is shown making a putt in the beginning of the ad, when recalling how he felt like he was at the top of the world. The missed chip shot appropriately came during the fair balance portion of the ad. The part that everyone hates!

I don't think the American public realizes the amount of thought that goes into these ads! If it wasn't for the FDA, much less thought would be needed and we wouldn't have people like me studying these ads and interpreting hidden meanings! (For the ultimate analysis hidden meanings in drug ads, see "Ruth Day and the Bees Repeat Performance at House DTC Hearing".)

P.S. Here's a little math/ROI problem thanks to a Twitter pal of mine. Assuming AMGEN/PFIZER spent $14 million to retain the endorsement of Phil Mickelson (not counting the cost of ad creative or media buys), how many ADDITIONAL doses of ENBREL will have to be sold to break even?

FaceBook Tweaks "Whitelisting" - No Problem for Pharma, Though

I've heard of placing your e-mail address on a "whitelist" so that you can continue to receive "junk" e-mail whose sender may be on a "blacklist" maintained by Spam Haus or some other agent that ISPs subscribe to. But I just learned from Intouch's Wendy Blackburn and Jim Dayton that social networks like Facebook also engage in a practice called "whitelisting."
"Over the last year," said Dayton, "Facebook has recognized the need for Pharma companies to disable certain functionality of their Pages due to FDA regulations. Most notably, this includes the disabling of the 'comment' functionality. Some companies have even requested the Like button be removed. As far as I know, Facebook has worked with companies to get this functionality disabled on an as-needed basis. This practice is called 'whitelisting'" (see "Understanding (More) Recent Facebook Changes").
IMHO, it is NOT true that FDA regulations require the disabling of certain FB functionality. I don't find any regulations from FDA regarding that. Nor warning letters. FDA, for example, did not send Sanofi-Aventis a warning letter about the comments published on its FB page by a "disgruntled patient" (see "Disgruntled Patient Shuts Down sanofi-aventis Facebook Page").

In fact, there is at least ONE pharma FB page that has comments turned on (see here).

Obviously, most pharma companies have what I call Social Networking Idiosyncratic Dysfunctional Episodes (SNIDE). Due to SNIDE attitudes, most pharma companies prefer that no consumer/patient communicate with them via social networks. It's just too much trouble and besides, we're not use to that! Of course, SNIDE sufferers blame FDA regulations instead of their own aversion to social networking.

Meanwhile, Facebook is in a quandary. If they make it easy for just anyone to turn off comments, then everyone will want to do that and there goes their social network. So they are now making it harder to get on the list (the "whitelist," that is). Dayton advises pharma companies that they "must contact your [Facebook] rep and discuss the use case and justification for needing any functionality changes." I don't think it will be much of a problem for pharma companies to be "whitelisted." Do you? BTW, I don't even have a Facebook rep. Do you?

FOLLOWUP: A conversation with Matthew Snodgrass, Social Media Director at WCG, about Facebook's planned changes to its "whitelisting" policy and its implications for pharmaceutical marketers:

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OMG! They Give Awards for the Most Money Spent Lobbying Congress!

Last night, John Castellani, president and CEO of PhRMA -- arguably the single largest Washington lobbyist (aka "advocacy group") -- was the recipient of the 2011 Bryce Harlow Business-Government Relations Award, which is given to individuals who have made "significant contributions" to the advocacy profession.

More like significant contributions to politicians!

John also had the "thrill" of meeting one of those politicians PhRMA has undoubtedly helped fund over the years. According to this obsequious post on PhRMA's blog, "John ... had the added thrill of being introduced by House Speaker Boehner. Many in attendance were touched by this gesture of professional respect and friendship on the part of the Speaker."

Yeah, I bet they are friends! Did Boehner bawl or just kiss John? Whatever. I'm sure PhRMA is happy with Boehner's efforts to derail health care reform -- especially the part that tries to close the donut hole in Medicare!

Weave Social Media Into Your Marketing Strategy

As reported by @shwen via Twitter:
"Social Media has to be integrated into the fabric of your overall marketing strategy" - Sara Larsen (SAP) #iStrategy
Here's my visual interpretation of that:

Regarding Social Media Advice & Guidelines, PhRMA Will Follow FDA's "Lead"

Now that the British pharmaceutical industry has published its advice to members about using social media for drug promotion (see "Brits Beat FDA & PhRMA: Issue Social Media Guidance for Pharma), the logical question to ask is "Should PhRMA (the US industry's trade group) follow ABPI's (the Association of the British Pharmaceutical Industry) lead and update its Direct-to-Consumer (DTC) Guidelines to cover drug promotion to consumers via the Internet and social media?" Although such advice and guidelines are voluntary and do not carry any legal weight, it would help the drug industry, which is not waiting for FDA guidance and is already doing quite a bit of promotion via social media.

When I asked PhRMA if it had any response to the Brit's published guidance and if PhRMA would follow ABPI's lead and update its DTC Principles to include "advice" on how to apply those principles online, I received this response from PhRMA attorney Jeff Francer (via Jeff Trewhitt, PhRMA's Media/Public Affairs spokesman):
"The Food and Drug Administration is taking the lead, and we're eagerly awaiting the guidance the agency is completing."
To which I responded:
"Ha Ha! I'm sure you guys know more about where FDA is going and when it will get there than I do!"
Whatever guidance the FDA may issue, it only will inform the drug industry how to stay within the LETTER of the law (ie, fda regulations). What's needed, IMHO, is some guidance on BEST PRACTICES that the industry should follow. Those best practices can go BEYOND the letter of the law.

PhRMA's voluntary DTC guidelines, for example, include principles that ban REMINDER drug ads (see definition here) on TV and Erectile Dysfunction ads on TV shows that children are likely to watch. Those principles go well BEYOND what the FDA requires.

Why not start thinking of social media principles that also go beyond what the FDA requires? That I believe is the role of voluntary guidelines and something appropriate for PhRMA to take the lead in developing.

Brits Beat FDA & PhRMA: Issue Social Media Guidance for Pharma. This BI Tweet May Not Pass Muster.

The Brits have won the race to issue social media guidance for the drug industry! (OK, it's NOT a race. Still, everyone says the EU regulators FOLLOW FDA's lead. Here's a case where the horse is following the cart!)

The Prescription Medicines Code of Practice Authority (PMCPA), which oversees the self-regulatory code of the Association of the British Pharmaceutical Industry (ABPI), just published "informal guidance" providing the drug industry advice on how to use online communications.

You can access the PMCPA "informal guidance" here.

While the US FDA (PhRMA too!) twiddles and delays, the British PMCPA tweets and delivers!

Most of the advice, however, is merely to follow the existing ABPI Code of Practice, which "applies irrespective of the method of communication." NOTE: In contrast to the British industry code, US PhRMA's DTC Guidelines specifically excludes online communications.

Regarding Twitter, PMCPA has this to say:
"If a company wanted to promote a medicine via twitter it would have to ensure that if the medicine was prescription only, the audience was restricted to health professionals and that the message, in addition to any link to further information, complied with the Code. In addition companies would also have to ensure that recipients had agreed to receive the information. Given these restrictions and the character limit on twitter, it is highly unlikely that the use of this medium to promote prescription only medicines would meet the requirements of the Code.
"Using twitter to alert health professionals about the publication of a study on a medicine is likely to be considered promotion of that medicine."
I interpret that to mean that Tweets such as the following from Boehringer Ingelheim (BI) may not pass muster with the Brits:

Back in October, 2009, I criticized tweets like this, which I thought violated FDA regulations (see "Boehringer's Branded Tweet Violates FDA Regulations Just Like Those 14 Paid Search Ads Did"). So far, however, FDA has not issued any NOV letters to companies who post such tweets. Maybe BI is out of the FDA's jurisdiction because the tweet was meant for an EU audience and not a US audience? And since BI is not a British Pharmaceutical industry, it is not obligated to comply with the ABPI Code.

While many industry pundits fault the FDA for not issuing social media guidance in a timely fashion, no one has put any blame on PhRMA (the US industry equivalent of ABPI) for not issuing its own voluntary industry guidelines regarding Internet and social media pharmaceutical promotion. No one but me, of course (see, for example, "PhRMA Finalizes DTC Principles").

Amgen's Prolia Website Features Stories from "Typical" But Not "Actual" Women Like You

You've probably been seeing DTC TV ads for several different osteoporosis drugs these days. No longer does Sally Field dominate the airwaves hawking Genentech's Boniva. AMGEN's twice-per-year injectable Prolia, for example, is now competing with once-per-month injectable Boniva.

Unlike Boniva, however, Prolia does not have a celebrity spokeswoman. What it has are "Women Like You."

The Prolia website prominently displays the option titled "Stories from women like you." Below is a screen shot of that option showing Karen, 71, who talks about Prolia.

Unfortunately, neither Karen nor any of the other "women like you," is an actual patient. Their stories, AMGEN claims, are "examples of typical patients--not the experiences of actual patients." Maybe it's difficult to get real patient stories for a new drug. I've heard from posts on CafePharma that sales of Prolia suck big time because few GPs want to prescribe a new, unproven biologic that remains in the body for a whole year. Plus there are re-imbursement issues.

Karen tells her story AS IF she were a real patient and provides details of how she fractured her left wrist. "I should be glad it wasn't my right [wrist]," says Karen. "My doctor said, 'Karen, you didn't get a fracture from being clumsy. You got a fracture from weak bones.'"

[BTW, I love the new age music in the background!]

Karen mentions that she is doing "everything my doctor told me to do to strengthen my bones." At first -- within the first two minutes of the video -- she only mentions getting a "shot every six months," which she "likes" and says"works for me." Later on, Karen does mention calcium pills, exercise, etc.

While Karen doesn't mention specific side effects, some specific side effects do pop up in the video frame in mouse-sized type that is difficult to read -- especially, I imagine, for older women. The last 2 minutes of the video highlights the important safety information using a scrolling text screen and a voiceover.

Perhaps, over time AMGEN will collect stories from ACTUAL patients to replace Karen and other "not actual patients" on its website. Meanwhile, I remain queasy about actors portraying "typical" patients in drug ads. Has the FDA issued any guidelines regarding what constitutes a "typical patient" in drug ads? FDA has issued warning letters about actors whose dialogue overstates benefits or downplays risks, but I don't recall any letter that questioned whether or not the portrayal is "typical."

Suppose, instead of a typical patient, AMGEN had a video of a "typical" physician? Would the FDA (or AMA for that matter) rise up and challenge the concept of a typical physician?

It seems to me that allowing drug marketers to use actors to portray what is labeled a "typical patient" is worse than using actual patients who tell real stories stories, even if those stories are not typical. At least we can challenge the veracity of "real" stories versus "typical" stories.

PhRMA Statement on FDA Social Media Guidance Delay

By now everyone is aware that the FDA has missed its SECOND deadline for issuing some form of guidance to the drug industry for the promotion of Rx products via the Internet and specifically via social media (see, for example, "No News is No News – DDMAC Fails to Produce Guidance").

Of course, further delay in issuing such guidance is very frustrating for the dozens of stakeholders who the FDA invited in November 2009 to make presentations at a public hearing.

To highlight that frustration, on April 1, 2011 (April Fools Day), I created a bogus PhRMA Statement, which included these memorable lines:
"Due to FDA’s limited resources and an increasing workload, FDA should seek out help developing social media guidance. PhRMA intends to continue to serve as a constructive partner in that regard. So why not give us a call or tweet us? We’ll be happy to draft some guidelines tout de suite."
“FDA says it wants the draft guidances ‘well thought out’ when they are issued. I mean, how difficult can it be? PhRMA Intern will be returning after the Spring semester is over and we can assign her to the project."
“FDA’s failure to act in this matter is a slap in the face of the pharmaceutical industry, which urgently requires social media guidance. ‘Let's Build Something Together’ is a famous tag line from Lowe’s Home Improvement. That sums up our position with regard to building FDA social media guidance as well."
The joke was successful as far as April Fools go and PhRMA had to act fast to contain the media's confusion. Christian Clymer (@CCatPhRMA), Social Media Lead for PhRMA, tweeted this in response to my post:
"Have you been fooled? See @pharmaguy April Fool's joke and PhRMA's real statement here... http://bit.ly/gEqjyz"
The link in his post leads to another note on PhRMA's blog:
April Facts v. April Fool's
by Kate Connors on 4/1/2011
Perhaps you’ve seen John Mack’s April Fool’s post that says he’s gotten a copy of PhRMA’s “statement” on the Food and Drug Administration’s delayed social media guidelines.
Mack’s post, which presents a fictitious statement, has made the rounds this morning, underscoring the immediacy of social media.
Here is our actual statement, released yesterday.
Go ahead and read PhRMA's ACTUAL statement. I think if PhRMA allowed itself to speak frankly, the real PhRMA Statement would have closely resembled my April Fools version. Now that April Fool's is over, I have removed the fake statement from this blog. See you NEXT April 1!