2010 in Images from Pharma Marketing Blog

2010 is in its final days and since I do not expect much of any importance in pharma marketing to unfold in the next two or three days, I decided to publish this Slideshare review of 2010 using images from Pharma Marketing Blog posts.

NOTE: You can click on the images in the presentation to read the original blog post.

Stay tuned for the 2010 Pharma Marketing Yearbook™. You can get a preview here and "sign" and find out how to sponsor the PMY here.

Remember 2010 & look fwd to 2011 by joining the Pharma Marketing Yearbook LinkedIn Group.

Scrooge FDA Delays Laying Social Media Guidelines Golden Egg: Why?

FDA's DDMAC is playing Scrooge to the drug industry's Tiny Tim this Christmas season and -- to mix metaphors -- won't be laying the golden goose egg everyone was expecting in 2010. The egg of which I am speaking, of course, is guidance for drug promotion via the Internet and social media.

According to a post over at EyeOnFDA, DDMAC issued this statement:

The Division of Drug Marketing, Advertising, and Communications (DDMAC) has been researching draft guidance topics on the following issues related to Internet/social media promotion of FDA-regulated medical products:
  • Responding to unsolicited requests
  • Fulfilling regulatory requirements when using tools associated with space limitations
  • Fulfilling post-marketing submission requirements
  • On-line communications for which manufacturers, packers, or distributors are accountable
  • Use of links on the Internet
  • Correcting misinformation
Our goal is to issue one draft guidance that addresses at least one of these topics during the first quarter of 2011, but we cannot comment any further at this point as to exactly when any draft guidance will issue or any specific order in which the topics will be addressed. The public will be notified officially when any guidance is issued via Federal Register announcements.

I am not sure where this statement was made or to whom exactly, but I'll take it at face value.

This delay does not bode well for all of us expecting action from the FDA. With the new, Republican-controlled Congress coming into session next year, "Lame Duck" (or Cooked Goose) FDA officials are likely to be summoned before Senate and House committees to testify and to be grilled by Republicans. FDA may have to defend a lot of its recent regulatory actions. Obviously, Republicans favor less regulation and not more regulation. This may set the atmosphere within the FDA to be less vigilant regarding the regulation of drug advertising in general and Internet advertising in particular.

Also, political battles are likely to rage during the next Congress regarding recent online privacy initiatives by the FTC and the White House. The FDA may be caught up in these battles and be forced to be more cautious about issuing Internet guidelines. The announced delay may even be the first sign of caution. I note that the Center for Digital Democracy, for example, said FDA was incapable of policing privacy issues related to online health marketing (see "New Media Privacy Issues & Online Health Marketing").

I'm Interviewed About Pharma & Social Media on This Marketplace Show Sponsored by Novo Nordisk!

About 2.30 minutes into this 8-minute Marketplace Morning Report is a short piece about pharma's use of social media for promoting drugs. I am quoted in the piece. Essentially, it's the same quote/sound bite that TIME used about pharma being "marginalized" if they do not figure out how to participate in social media discussions (see "Pharma is "Cleverly Navigating" the Social Media Space Says TIME Magazine").

My segment is preceded by an ad for Novo Nordisk, "since 1923 innovative developer of diabetes treatments and delivery devices." It's interesting that Novo Nordisk is a sponsor of this MarketPlace segment because its Race with Insulin campaign was also featured in the TIME magazine story, which called its twitter social media campaign "provocative."

Both stories are ambivalent regarding pharma's use of social media and may even be said to be supportive of pharma's cause to push the FDA into releasing guidelines. Both stories also say that FDA will release these guidelines before the end of the year.

It could be a coincidence that Novo Nordisk is linked to both these stories, but I'm beginning to feel that I am been played like fiddle by a Novo Nordisk engineered PR campaign! What do you think. Listen to the embedded Marketplace segment below (or find it here after it is archived as a podcast dated 12/20/2010).

Medical Schools Don't Ask & Faculty Don't Tell If They Violate Ban on Paid Pharma Speaking Gigs

ProPublica -- the non-profit newsroom that produces investigative journalism in the public interest and which received a Pulitzer Prize for investigative reporting -- recently published a story revealing that physicians from Stanford, Penn and the Universities of Pittsburgh and Colorado Denver have faculty members who have accepted money to promote drugs despite the fact that these universities have conflict of interest policies that restrict their doctors from accepting pharma money (see "Medical Schools Don't Verify Faculty Compliance with Ban on Pharma Speaker Fees").

This is just the latest revelation made possible by comparing names in ProPublica’s Dollars for Docs database of payments publicly reported by seven drug companies with names of faculty members at a dozen medical schools and teaching hospitals.

Here's an example:
The University of Pennsylvania health system’s 2006 policy states that faculty “should not participate in industry marketing activities.” Penn’s chief medical officer, Dr. P.J. Brennan, said he interprets that to prohibit delivering drug company lectures.

“It flies in the face of what a professional ought to be,” he said.

ProPublica found 20 Penn speakers in its database. Five, including one who left Penn last month, made more than $40,000.

The top paid, according to Dollars for Docs, was Dr. Corey Langer, director of thoracic oncology at Penn’s Abramson Cancer Center. He received nearly $70,000 speaking for Lilly since 2009.

Langer also received unknown amounts from other companies, including Genentech Inc., OSI Pharmaceuticals Inc., Bristol-Myers Squibb Co. and ImClone Systems, according to his disclosure for a medical education program this month.

In an e-mail, Langer said he was “now fully aware” of Penn’s policy and is “taking measures to curtail speaking for pharmaceutical companies.”
"When it comes to enforcing the policies, universities have allowed permissive interpretations and relied on the honor system," said the authors of the article. "ProPublica’s review shows that approach isn’t working: Many physicians are in apparent violation, and ignorance or confusion about the rules is widespread."

Several physicians claimed they didn't know they were in violation of their school's policies. This is similar to what you might say to a cop after being caught running a late-night blinking red stop light.

“For God’s sake, if the media can look at these websites, why can’t we?” said David Rothman, president of the Institute on Medicine as a Profession at Columbia University. “Why trust if you can verify?”

But it's not yet easy for all schools to verify compliance using ProPubica's database or any other database of pharma payments to physicians. For one thing the majority of drug companies in the United States don’t report such payments. This is supposed to change by 2013 when the Physician Sunshine Act will require all drug companies to report these payments (see "Capturing & Reporting HCP-Related Meeting Spending"; use discount code 'HCP399' to get it FREE!).

Pharma is "Cleverly Navigating" the Social Media Space Says TIME Magazine

"Surprisingly, it's the pharmaceutical industry that's been at the forefront of moving the FDA to issue social-media rules," reports TIME Magazine reporter Steven Gray in a story published online today (see "Drug Companies Take Their Pitch to Social Media — Carefully").

Steven interviewed me for this story and quotes me in this passage: "The companies realize their traditional websites and advertising strategies are no longer sufficient tools to promote products in a competitive marketplace in which doctors, pharmacists and consumers aggressively trade information about medicine on blogs. The companies are also aware that 'if they can't fully participate in the social-media conversation, they get marginalized,' says John Mack, publisher of Pharma Marketing Blog, which attracts about 25,000 industry readers a month."

I thank Steven for this 10 minutes of fame.

Steven's article focuses exclusively on Novo Nordisk's Race with Insulin Twitter campaign (@racewithinsulin), which is described as "one of the most provocative examples of how pharmaceutical companies are cleverly navigating the emerging, largely unregulated social-media space." "Provocative," yes. "Cleverly navigating," not so much. I only need to point out the story about how sanofi aventis not so cleverly launched a Facebook page to debunk that (see "Where's Your Social Media Crisis Management Plan?").

The article is actually a very good PR piece for Novo Nordisk and Race with Insulin. Although I mentioned to Steven my blog post heard about Kimball's infamous branded Tweet heard round the world (see "Novo Nordisk's Branded (Levemir) Tweet is Sleazy Twitter Spam!"), this wasn't mentioned in the article. That particular tweet was not particularly clever, although I agree that it was provocative.

You've no doubt heard from many industry people that the media is out to get them and write negative stories about the drug industry. In fact, that's the kind of story I was expecting Steven to write. He, for example, wanted me to OK his use of the word "provocative" to describe the Race with Insulin social media campaign. The TIME piece, however, is not provocative and does not attack the drug industry for its efforts, which is fine with me. Just remember this the next time an industry executive complains about the media!

Pfizer's Sales Reps Have 48 Hours to Out Deliver eSampling Program. #FAIL!

Pfizer has become the latest drug company to offer doctors the option of using the Internet to order free samples of its drugs, a trend illustrating the diminished role of sales representatives, whose ranks continue to decrease (see PR Newswire). The service is called SamplesDirect.

The WSJ Blog reports that the fear among Pfizer reps was that online sampling would only further erode their job function. "But Pfizer reached a compromise with its reps: when a physician places an e-order, it’s flagged to his or her sales rep, who has 48 hours to step in and personally take over the order. If the rep doesn’t act, the order is filled electronically."

Suppose you ordered a book from Amazon.com and expected prompt overnight delivery, but your order was placed on "hold" for 48 hours to allow a brick-and-mortar local bookstore to fulfill your order? Is that a model destined for success or the trash bin? I think we all know the answer to that.

Some Pfizer sales reps also seem to understand that they are being "duped" by Pfizer's claims that this will "keep them in the loop." Here's some chatter about this heard on the Cafepharma's Pfizer Company Discussion Board:
"Why spend $300 for a sample drop when FedEx will do it for $20. Forcing reps on physicians to drop sample - the old pharma model continues"

"This is a joke, reps have 48 hrs to deliver the goods ? Why not overnight them for $10 and not pay the rep $400.00 / day income. Gas and insurance in the car etc. Folks this gig has a very very short horizon ahead, think for yourselves."
Other anonymous CafePharma "reps," however, think it is a good idea:
"Reps are right, the sample calls are a huge part of getting in to see the Drs. The other side is, no sample calls, no calls."

"it's much more convincing when you have a rep "close" a doctor and won't take no for answer that you know you're going to have to callback for more freebie samples to subsidize those patients complaining about their doctors bills!"

"This is actually positive for the rep as they will have a reason to see the MD due to their need of samples. It is up to the rep to act with a sense of ugency."
This last post received this rejoiner: "Obviously, the home office is reading and posting on Cafepharma." Maybe, but home office types do not make spelling mistakes!

It will be interesting to know what percent of eSample orders were hand-delivered by Pfizer reps who beat the 48-hour deadline. Pfizer's SamplesDirect service launched in August, so they must have some data. But I don't suppose they'll share it with us.

Whether or not eSampling assuages the fears of current reps, it does not bode well for the sales force in general and for hiring new reps to replace the old. You cannot argue with the business imperative of reducing costs. If "sample calls are a huge part of getting in to see the Drs" and most doctors can get product information from sources other than reps (eg, the Internet), then most docs will only want to see reps who have samples. If they can order those samples online, then there is even less reason to see reps. They'll just wait out the 48 hours and get their samples by UPS while blocking all Pfizer reps from visiting. Pfizer also has an economic incentive to make sure eSamples are delivered without reps -- ie, $20 for eSampling vs. $300 for a rep "sample drop." Plus, doctors are going to be pissed off that the delivery is delayed and that their online orders may actually cause a rep to visit!

The temptation to push that "easy" button BEFORE 48 hours is up is great!

Pharma's 2010 Christmas Wish List for Santa

A few people helped me put together a short wish list for the US pharmaceutical industry to send to Santa this year (you can still vote or write-in your item to include on the list; see survey here).

There are only 3 items on the list so far that merit Santa's urgent attention:

(1) Left over from last year's list: Guidance from the FDA on how it will regulate drug promotion on the Internet and social networks. This, of course, is the most important item on the list. In last year's letter to Santa (find it here) pharma said: "Do I need to mention how much we would like guidance from the FDA on how it will regulate drug promotion on the Internet and social networks? Right now, we are really hurting because we cannot advertise on Google."

Recently, a Time Magazine journalist interviewed me for an article he's writing on pharma's use of social media. He was shocked to learn that the lack of guidance from the FDA is holding pharma back from doing more on social networks. Of course, I've always maintained that this is a red herring used as an excuse for the unwillingness of most product managers to do something different and essentially unproven.

According to a new Deloitte report titled, “To Friend or Not? New Insights About Social Networks in the Life Sciences Industry," undefined Food and Drug Administration (FDA) guidelines, consumer privacy concerns and a lack of a clearly demonstrated return on investment are the top three hurdles to widespread adoption of social media by the pharmaceutical industry (see more survey results here). Nevertheless, 65% of survey respondents say their company uses or plans to use social networks at a company level in some capacity in the next year.

(2) Everybody seems to have an itch to modify the healthcare reform law. So it's no surprise that 22% of respondents to my survey chose Amend the healthcare reform law so that drug industry won't have to help finance the Medicare "donut hole" through discounts for prescription drugs as an item to include on Santa's list.

As reported by FiercePharma, "starting next year, drugmakers have to give a 50 percent discount on branded drugs for people who fall into the gap, which is between $2,830 and $6,440. Over 10 years, the cost of closing the hole could cost pharma $32 billion, the [Wall Street] Journal reports."

Two pharma companies have responded very differently to this "deal" with democrats to help cover the gap in Medicare drug coverage. Whereas Lilly hemmed and hawed and skirted the issue and mainly defended high drug prices (see "Why Price Controls Are Not The Right Answer" and my comments here: "LillyPad Launches Specious Rocket Attack Against Drug Price Control Straw Man"), AstaZeneca seized the moment to support the coverage and explain how else it is helping senior citizens pay for their prescription drugs (see "Our Fair Share: Closing the Coverage Gap").

Although filling the "Medicare "Doughnut Hole" will cost pharma less than 1% of US sales (see here), it can't hurt to ask Santa for a reprieve.

(3) Of equal importance to the doughnut hole wish is pharma's wish that the FDA adopt A regulatory pathway for the approval of biosimilars that the drug industry can live with. 22% of my survey respondents voted for this item. Biosimilars are generic versions of large-molecule patent drugs (biologics).

At one point in the negotiations with FDA, the drug industry argued that biosimilars need to be tested in humans before being approved as generic substitutions for patented, FDA-approved biologics. Marc Monseau, Director of Corporate Communications at Johnson and Johnson, once wrote: "These products [biosimilars] would be 'similar' to a branded product, but they would not be the 'same' and therefore, scientists do not consider them to be generics. Since laboratory testing isn't enough to detect many of the clinically important differences in biologics, testing in humans will be necessary to ensure their safety and efficacy."

Nowadays, however, the industry is focused on making sure new regulations "should include a data exclusivity period of 12 years - meaning that the FDA would have to wait 12 years after a biotech drug has hit the market before approving a follow-on version. The generic drug industry, represented by the Generic Pharmaceutical Association, as well as several consumer and patient advocacy groups, favored a five-year exclusivity period similar to the one used for pharmaceutical drugs" (see here).

(4) The last -- and least important -- item on pharma's wish list for Santa is Much fewer "warning" letters from FDA in 2011. As you may know, the FDA has been sending out more of these letters during Obama's administration. This is nicely summarized in the following chart prepared by EyeOnFDA (see here):

At this rate, the number of warning letters will get back to Clinton-era levels before the next election when a new FDA commissioner may be named by a newly-elected republication president (John Boehner?). Now that the next Congress will have a republican majority, we're likely to see this wish fulfilled as FDA officials are grilled by Senate Committees headed by Republicans.

Not that Santa Claus is a Republican! He surely is a Democrat because he's in favor of entitlement -- all good boys and girls and even pharma companies (good or bad) get gifts!

BTW, there were a couple of write-ins for the list:
"A pipeline in a pear tree" -- I have added this to the official survey voting block.

"Human Genomes Sciences' Lupus Drug, "Benlysta"! We Lupies need this quickly-Unfortunately, I know a woman who may not see Christmas because of the FDA delay now. She's in the hospital on a respirator, because Lupus has attacked her lungs and now kidneys. Please help her Santa!" -- I can't argue with this, which I put in the same category as "increased pipeline."
There's still time to get your vote in here.

P.S. Added "fewer law suits" & "increased pipeline" to pharma's XMAS wish list. What's ur favorite(s)? http://bit.ly/dMcr5M

Pharmaguy a la Milanese: Deal with Regulations and Develop Best Practices

Pharma's interest in social media is a global phenomenon. I've traveled to the UK and Germany in the past year to present at conferences about what's happening on the pharmaceutical social media front here in the U.S. and its impact on pharmaceutical marketing elsewhere in the world.

My next trip to Europe will be to Milan, Italy, where I will speak at the 6th Annual Pharma Marketing & Branding Excellence conference on January 26. I thank the conference producers -- Jacob Fleming Conferences -- for inviting me to speak and paying my travel expenses.

The title of my presentation is "A Social Media Strategy: Deal with Regulations, Develop Best Practices." Here's the synopsis:
While the benefits of using social media tools as part of your marketing strategy may be clear to your team, the risks are unknown. That’s because there is no bright line that defines what is acceptable to regulators, consumers, and healthcare professionals. Add to this the fact that new tools are being developed at a raid rate, which makes it that much harder to find the line. Each company must access its regulatory risks and develop best practices that not only address those risks, but also instill trust in the audience. This presentation will cover the following:
  • An overview of the regulatory issues pharma companies are facing when they engage in social media
  • How to overcome the barriers and risks of having insufficient regulatory guidance on Social Media in Pharma
  • Regardless of the regulations, what are some social media best practices that companies should consider?
  • What internal and external social media policies & procedures should companies adopt before engaging in social media?
I'm looking forward to meeting new people, especially new Pharma Social Media Pioneers to whom I give a lapel pin!

Frankly, I'm hoping that the FDA will release some draft guidance before I leave for Italy so that I can really have something new to talk about. But we're now well in to the holiday season and there has been some concern amongst my Twitter pals that the FDA will not release guidelines by the end of 2010 as we all expected and as the FDA "promised."

But one other issue has arisen that I will incorporate into my presentation: New Media Privacy Issues & Online Health Marketing

I'll also check with locals about my Osso Bucco recipe, which at least one commenter on YouTube claimed was not authentic ("please for the sake and the respect for the italian cuisine never say that what you cooked is ossobucco"; see "Osso Whaaaat? Mack's Osso Bucco recipe!").

Pharmaguy Alerts FDA About BadAd Technical "Glitch"

I just received an email message from the FDA thanking me for calling their attention to a "technical glitch" in the auto-response to submissions to its "BadAd" program (see email message reproduced below; click on it for an enlarged view).

It's gratifying to know that I have been of service to my country. I wonder, however, why this "glitch" wasn't noticed until now. The BadAd program was launched by the FDA in May 2010 (see press release).

It's impossible to know how many people/HCPs like me submitted a report about a potential violation in drug promotion by sending an email to badad@fda.gov or calling 877-RX-DDMAC. "While we cannot provide status updates on ongoing investigations to persons outside the Agency," says the FDA, "health care providers can subscribe to our e-mail updates to receive information about the program and notifications of actions taken as a result of the program."

It appears that I have been subscribed for quite some time, but have not received any notices until today. It reminds me of the time I submitted a complaint to PhRMA's Office of Accountability (see "PhRMA's Response - PRwise, it Stinks!").

WikiLeaks: Pfizer Hired Investigators to Smear Nigerian Prosecutor in Press

Pfizer was sued after a 1996 Nigerian meningitis trial in which 11 children died during the testing of its new antibiotic Trovan against the standard treatment ceftriaxone. Read the litigation details on Wikipedia.

An InPharm article reveals that "US embassy cables released by WikiLeaks purport to show Pfizer’s country manager Enrico Liggeri was aware of a smear campaign against Nigeria’s attorney general, Micheal Aondoakaa to 'expose him and put pressure on him to drop the federal cases'." Pfizer denies this (read the InPharm article).

Here's the relevant sections of the cables released by WikiLeaks and published in the Guardian here:
Pfizer Exposes Attorney General


5. (C) In follow up to the April 2 meeting, EconDep met with Pfizer Country Manager Enrico Liggeri in Lagos on April 9. (Note: Liggeri has years of experience in Nigeria because his family operated a business in Lagos from the early 1960s to the late 1980s. He spent most of his childhood in Lagos. End Note.) Liggeri said Pfizer was not happy settling the case, but had come to the conclusion that the $75 million figure was reasonable because the suits had been ongoing for many years costing Pfizer more than $15 million a year in legal and investigative fees. According to Liggeri, Pfizer had hired investigators to uncover corruption links to Federal Attorney General Michael Aondoakaa to expose him and put pressure on him to drop the federal cases. He said Pfizer's investigators were passing this information to local media, XXXXXXXXXXXX. A series of damaging articles detailing Aondoakaa's "alleged" corruption ties were published in February and March. Liggeri contended that Pfizer had much more damaging information on Aondoakaa and that Aondoakaa's cronies were pressuring him to drop the suit for fear of further negative articles.

6. (C) Liggeri commented that the lawsuits were wholly political in nature because the NGO Doctors Without Borders administered Trovan to other children during the 1996 meningitis epidemic and the Nigerian government has taken no action. He underscored that the suit has had a "chilling effect" on international pharmaceutical companies because companies are no longer willing to conduct clinical testing in Nigeria. Liggeri opined that when another outbreak occurs no company will come to Nigeria's aid.

7. (C) Comment: Pfizer's image in Nigeria has been damaged due to this ongoing case. Pfizer's management considers Nigeria a major growth market for its products and having this case behind it will help in efforts to rebuild its image here. Final discussions on the $30 million and $35 million are likely to be tricky because the Nigerian side wants to control who gets the money, not Pfizer. The U.S. Mission will continue to advocate for transparency in settling the case and also note to GON authorities that Pfizer must abide by the U.S. Foreign Corrupt Practices Act and cannot simple hand over large sums of money to state and local officials. Petrosinelli and Adams will get back to the Mission on what further assistance may be needed. End Comment.

Pfizer Responds, But Did I Get an Answer?

On the urging of a FaceBook friend, I behaved like a "journalist" and contacted Pfizer directly about an issue I raised regarding a Lyrica print DTC ad. For background, see here and here.

Pfizer did respond to me in a timely manner, which I appreciate given the current state of media frenzy regarding the resignation -- I mean retirement -- of Kindler, Pfizer's CEO. I'm not sure if Twitter facilitated the process or if my multiple phone calls/voicemails to various media people at Pfizer were responsible. Within a couple of hours, however, Chris Loder, Pfizer's Head of US Media Relations, gave me a call and said he needed some time to research the issue, but promised someone would followup soon.

After Chris called, I sent him this email so Pfizer could respond to a specific issue I was interested in:
Thanks for getting back to me regarding a Lyrica DTC ad in the December 2010 issue of Prevention Magazine ("What's causing your chronic widespread MUSCLE pain?"). I know you have seen my main blog post about this but I'd like to call your attention to this comment I received because it gets to the heart of the matter:

"... you can't make up an indication based on your MOA or preclinical data, and I do believe that Lyrica is trying to expand its indication beyond diabetic neuropathic pain and fibromyalgia (which cannot accurately be described merely as chronic muscle pain). There are other non-opioid agents now receiving chronic musculoskeletal pain indications, and I think Lyrica is trying to muddy the waters and gain some additional share of that market without bothering to do the hard clinical research and face the enormous placebo effect that comes with any pain studies."
About 4 hours after that I got an email from Victoria Davis, Senior Manager, Media Relations at Pfizer. Read what Davis had to say and then tell me your opinion.
In regards to your questions regarding the Lyrica ad, please find our statement below.

“The DTC campaign is designed to educate patients about the symptoms of fibromyalgia and encourages patients to have a discussion with a healthcare provider about their symptoms. Through illustration, the ads show how overactive nerves may cause the chronic widespread muscle pain that is characteristic of fibromyalgia. The ads also highlight how Lyrica is believed to work by calming these overactive nerves to provide relief from fibromyalgia pain.

“The elements included in the print ad were included in pre-clearance with the FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC).

“The statements that ‘fibromyalgia is chronic widespread muscle pain thought to be caused by overactive nerves,’ and that ‘Lyrica is believed to calm these nerves’ are scientifically supported. Data supporting these and similar statements have been published in many peer-reviewed journals, including Nature Clinical Practice Rheumatology (now re-titled Nature Reviews Rheumatology) and Epilepsy Research.”

Please let me know if you need anything else.
I am particularly concerned with the FDA "pre-clearance" statement made by Davis. This implies that the FDA gave its OK when, in fact, FDA does not commit to approving ads BEFORE they are run. It can still cite ads for violations AFTER they have been submitted on Form 2253. FDA requires these submissions to be made " . . . at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement for a prescription drug product." Companies can choose to submit materials BEFORE initial dissemination of the ad and get some "opinions" from the FDA. But FDA does not APPROVE any ads BEFORE they are run. Here's the DDMAC FAQ on that:
Does FDA "approve" advertisements and promotional labeling before use by the company?

No, except in rare instances, when FDA may require pre-approval of promotional materials as part of an enforcement action. However, DDMAC provides opinions on proposed advertisements and labeling pieces before use upon request by an applicant. Note that accelerated approval products are under a "presubmission" requirement. The accelerated approval regulations require that applicants submit to FDA copies of all promotional materials prior to the intended date of dissemination or publication.
In any case, I do not think that Pfizer's response was sufficient to answer my question, which asked for SPECIFIC references to support the claim that Lyrica "calms" over-active nerves. I have responded by email to Davis asking for these specific references.

FOLLOWUP: I sent Davis this followup email:
Thanks for your response. However, I was hoping for something more specific, ie, specific references to the medical studies that support the claims. Can you tell me, for example, if these claims are also made in marketing materials provided by Pfizer to physicians? If so, wouldn't those materials include specific references? If not, why not (ie, why are these claims not made in physician promo materials)?
To which she responded:
"Here are the references.

Staud, R. and Rodriguez, M. “Mechanisms of Disease: Pain in Fibromyalgia.” Nature Clinical Practice: Rheumatology. (2006), Vol. 2, No. 2

Taylor, C. et al., “Pharmacology and mechanism of action of pregablin: The calcium channel (alpha2-delta) subunit as a target for antiepileptic drug discovery.” Epilepsy Research (2007), doi: 10.1016/j.eplepsyres.2006.09.008
The last paper supports the claim that Lyrica "calms" over-active nerves. The abstract states: "The preclinical findings to date are consistent with a mechanism that may entail reduction of abnormal neuronal excitability through reduced neurotransmitter release." But this is a review and not a clinical study and it is not concerned with the mechanism of action, but only "addresses the preclinical pharmacology of pregabalin, and also the biology of the high affinity binding site, and presumed site of action." Furthermore, the author is a Pfizer employee who works at the "Department of CNS Biology, Pfizer Global Research & Development, 2800 Plymouth Road, Ann Arbor, MI 48105, USA. charles.taylor@pfizer.com"

This is the end of the road for me as far as investigating the validity of the claims made in the Lyrica ad. I leave it up to you and the FDA to determine if Pfizer has made its case in support of the claims made.

Ad Execs Not Viewed as Innovative By Americans Says AstraZeneca Survey

Sorry to break this to you, but Americans don't think advertising executives are very innovative. This is according to the AstraZeneca Innovation Survey (find it here).

"By carrying out this survey we sought to shed some light on what innovation means to people around the world and whether they believe it is valuable to society as a whole," said David Brennan, AZ CEO.

The survey shows that Americans think advertising executives are only as innovative as teachers, but much less innovative than doctors, artists, engineers, or scientists (see chart below; click on image for a larger view).

But in the "emerging" nations of India and China -- where pharma pins its hopes for the future of sales -- advertising executives are seen as much more innovative than doctors and somewhat more innovative than musicians.

I'm thinking of starting up an Indo-Asian edition of Pharma Marketing News!

"Distributed Denial of Service" Attacks: Is Pharma Ready for Cyber Warfare?

I think it was an American journalist (A.J. Liebling) who said "Freedom of the press is guaranteed only to those who own one." I was reminded of this after Senator Joe Lieberman pressured Amazon.com to remove WikiLeaks docs from its cloud servers and Amazon complied.

This concerns me. But of even greater concern to me is the spate of hacker attacks against Wikileaks and counter-attacks against Amazon and other web sites like Mastercard and Paypal that have also ceased doing business with WikiLeaks (see, for example, "Hackers Give Web Companies a Test of Free Speech").

Who's next?

Perhaps pharmaceutical companies are next. What's to prevent some hacker from deciding that the Lyrica.com web site should be shut down because he/she took issue with print ads that may be in violation of FDA regulations (eg, see "Pfizer's Latest Lyrica DTC Ad Should Be Cited By FDA as Misleading")?

I am not technically savvy enough to know how these attacks are done, but I understand it's a fairly simple thing to do. And I don't know how Web sites can protect themselves from hacker attacks in general.

But one thing I suspect: many pharmaceutical may not have a plan in place to protect their web sites. I know form experience that even the largest pharmaceutical company in the world was not too technically savvy about how to start up a twitter account and keep abreast of what was being said about it on Twitter (see "Follow Who's Following Me on Twitter. But NOT Phishy 'pfizer' Please!").

What do you think?

My Pharma Social Media Communication Experiment

I'm trying a little experiment today. I'm trying to use social media -- specifically Twitter -- to directly contact the press relations people (aka corporate communications staff) at a major pharmaceutical company (ie, Pfizer) about a Lyrica print ad that I blogged about a few days ago (see "Pfizer's Latest Lyrica DTC Ad Should Be Cited By FDA as Misleading").


I was urged to do this after the following exchange with Bruce Grant on my Facebook Page:
  • Bruce Grant I think you should ask to see the evidence rather than speculate that it does not exist.
    Tuesday at 9:51pm · 

  • John Mack Well, Bruce, in this day and age of social media, I think what I did on my blog WAS to ask. Also, IF there is such evidence, my point is that it SHOULD be cited in the ads themselves.
    22 hours ago · 

  • Bruce Grant I remember the original social media -- mail and telephones. And when I was a journalist and had a question like this, I would call or write directly to the company with my inquiry...not wait to be overheard. Just sayin'. (BTW, did you check the Brief Summary page for references?)
    John Mack
    I did check the brief summary page, but I must admit I did not look for references. I will do that and see what I can find. Thanks for pointing that out. Usually, however, in physician ads anyway, there would be an asterisk to call attentio...n to specific sources of data cited.

    As I often say, I am NOT a journalist, especially when I am writing the blog. As you know, I have limited resources, except for my readers who often help me find answers. And that's really the point of my blog -- to stimulate discussion, which is the one thing many people say they appreciate. I will continue to respond to that need expressed by my readers.
I know for a fact that @Pfizer_news -- Pfizer's official corporate Twitter account -- follows me on Twitter. Pfizer uses this account to communicate Pfizer news to journalists among other stakeholders. Although I am not a journalist, I know that Pfizer is interested in keeping bloggers like me in the loop (see, for example, "The Social Media Revolution Will Not Be 'Televised'").

So, here's what I have done:
  1. I tweeted this today at about 7:30 AM: "I hv bn urged by @grantbw 2 contact @Pfizer_news re this Lyrica print ad that I think FDA shld cite as misleading: http://bit.ly/fGBhwl" and
  2. I DM'd (sent a direct message through Twitter to) @pfizer_news: "Who can I call about this Lyrica ad issue: http://bit.ly/fGBhwl" I also followed up with a DM giving Pfizer my phone number and direct e-mail address in case they want to respond to me "old school."
Since @Pfizer_news follows me, the person who monitors that account may see my tweet and SHOULD get my DM.

Everyone seems to be praising social media apps like Twitter for their communication abilities and I sure find it more convenient to use Twitter to contact Pfizer directly rather than witing for regular business hours to call by phone, which I know will be hellishly frustrating!. This is an experiment to see if it works. I will keep you posted.

UPDATE #1: At 11:49 AM I received this DM from @pfizer_news: "I've forwarded your message to Victoria Davis. Thanks." Victoria Davis is a Pfizer Media Relations primary care specialist who focuses on these products: Chantix, Lipitor, Apixaban, Premarin Family, Spiriva, Viagra and Pristiq. I'm not sure why @pfizer_news passed on my message to Victoria instead of, for example, Mackay Jimeson who is responsible for Lyrica, Celebrex, Spiriva, Toviaz, Dimebon, Apixaban, Tanezumab, Lipitor, Viagra, Chantix. But it's all good.

Meanwhile, beginning at about 9:10 AM I started calling by phone some of the people listed on Pfizer's News & Media page, including Chris Loder, Christine Neese, and MacKay Jimeson. I also called the general media contact number. They all were not available, so I left voicemail messages.

Finally, around 1:30 PM, Chris Loder, Pfizer's Head of US Media Relations, gave me a call and said he needed some time to research the issue, but promised someone would followup soon.

So, I'm happy to report that Pfizer is listening & responding via Twitter/social media. But I am not sure if it was Twitter or all the phone calls I made that got the attention of Chris. My bad for not doing a very good controlled study.

More later...

Pfizer's Latest Lyrica DTC Ad Should Be Cited By FDA as Misleading

Do you have "chronic widespread MUSCLE pain?" That's the question asked in a Lyrica direct-to-consumer (DTC) print Ad in a recent issue of Prevention magazine (see image below). "The answer may be over-active NERVES," says the ad. The implication is that Lyrica treats "muscle pain" caused by "over-active nerves."

Yet Lyrica is officially approved by the FDA "to treat Diabetic Nerve Pain, Pain after Shingles, and Fibromyalgia. LYRICA is also indicated to treat Partial Onset Seizures in adults with epilepsy who take 1 or more drugs for seizures." Neither "widespread MUSCLE pain" nor "Over-active NERVES" is mentioned in the approved labeling for Lyrica. And the National Institutes of Health (NIH) says that the causes of fibromyalgia are "unknown."

Pfizer even includes a diagram (left) showing how Lyrica "calms" the nerves, which "can provide significant relief from Fibromyalgia pain."

I think that all this is speculative hocus pocus that is not based on any reputable science at all! This is shameful coming from a company and an industry that promotes itself as being "science-based."

I'd like to see (1) references to scientific data, trials, etc. that supports Pfizer's hypothesis that fibromyalgia, aka "widespread muscle pain", is caused by "over-active NERVES" and (2) data to support the claim that Lyrica "calms" over-active nerves.

FDA "warning letters" often state that "Promotional materials are misleading if they suggest that a drug is useful in a broader range of conditions or patients than has been demonstrated by substantial evidence or substantial clinical experience." If Pfizer has no data to support the claims made in this ad, then the FDA should cite it as being misleading. That's my opinion. What do you think?

Abbott Fetes Barred Cardiologist with High Cholesterol Pig Roast

Practically every week I read amazing stories about stupid, immoral, unethical, or illegal activities perpetrated by the pharmaceutical industry. Stories that are bolstered with juicy quotes from internal corporate emails written by dumb executives. And I don't have to wait for Wikileaks to publish this stuff when the U.S. Senate and the Wall Street Journal (WSJ) are already doing it!

Take today for example. A story in the WSJ titled "Abbott Hired Barred Doctor" caught my attention (find it here). At first, I thought it was nothing new -- I already know that pharmaceutical companies have hired questionable physicians in the past, so it's not too exciting to learn that Abbott "hired a Baltimore-area cardiologist as a sales consultant after he was barred from practicing at a local hospital last year for allegedly putting heart stents in hundreds of patients who didn't need them."

What's interesting is the juicy stuff that the Senate learned from internal emails written by Abbott executives.

For example:
"In 2008 Abbott paid more than $1,000 for a pig roast, complete with mobile pig pit, at a party to fete the cardiologist the same week Dr. Midei, then head of the cardiac catheterization lab at St. Joseph Medical Center in Towson, Md., set a possible company record by implanting 30 stents in a single day."
"Charles Simonton, the medical director of Abbott's vascular division, said in another email cited by the [Senate report to be released today] that Dr. Midei should 'clearly avoid' the Baltimore area, but Dr. Simonton encouraged colleagues to 'please find key physicians or cath labs you'd like him to get in front of with our data.' Abbott wanted to hire Dr. Midei 'because he helped us so many times over the years,' yet another Abbott executive said in an email."
"Around that time, an Abbott executive complained to a colleague by email about one of the [Baltimore] Sun's journalists [who reported on the alleged overuse of stents at St. Joseph] 'Somebody needs to take this writer outside and kick his ass. Do I need to send in the Philly mob?' he wrote, according to the report."
What's really amazing is that a company supposedly dedicated to saving lives of patients with cholesterol-blocked coronary arteries would host a $1,407 pig roast complete with a mobile "Alabama pig pickin' pit," a whole pig smoked for 15 hours, Memphis-style ribs, chicken, hot dogs, cole slaw and two big peach cobblers. The only thing heart-healthy on that menu may have been the cole slaw! I can forgive the threat to kick the reporter's ass, but a pig roast in a cardiologist's back yard? Unforgivable!

Viagra Website Goes Dark!

No, Viagra.com hasn't been the target of "distributed denial of service" attacks by "unknown hackers," nor has Amazon pulled the site from its servers following political pressure from Senator Joe Lieberman, who chairs the Senate Homeland Security Committee. And Lieberman did NOT call for organizations hosting Viagra.com to terminate their relationship with the website.

All that's not likely to happen because here in America we value the freedom of information and believe the first amendment applies to corporate speech as well as to individual speech.

But Viagra.com has moved to the dark side and has become the first Rx drug site to use a black background, as far as I am aware (see screen shot below).

Several weeks ago, I noticed a similarly dark Viagra print ad in a magazine (see "Be a Macho Man! Ask Your Doctor for Viagra!"). The Viagra.com web site continues the "macho" theme as well.

Man, I'd love to be like one of these guys! Own a private plane and even know enough to work on its engine as well as not panic when my OLD car's water temperature gauge goes into the red zone while I'm driving  through the desert! Who knew such guys had ED (erectile dysfunction)?

ED guys don't have to ask mechanics for help on the road, but they DO have to ask their physicians for help getting an erection (ie, a prescription for Viagra). That's the best advice Viagra.com can offer!

P.S. Delving a bit deeper into the Viagra.com Web site, I find that "ED is More Common Than You Think" in the "Common Questions" section. There, Pfizer claims that "MORE THAN HALF OF MEN OVER 40 HAVE SOME DEGREE OF ED." I've often taken issue with this statement, so I researched the source that Pfizer cites for this: The Massachusetts Aging Men Study, which found that 52% of respondents claimed they had some degree of ED. Another analysis of this study concluded "Men who worked in blue-collar occupations were one and a half times more likely to develop ED compared to men in white-collar occupations" (see here). So why aren't blue-collar men depicted in Viagra ads instead of professional-looking guys and guys who own their own private planes? I doubt many blue-collar types are able to afford their own private airplane these days. What kind of world does Pfizer think we live in????

Are You Serious?TM A Good Example of Why Pharma Brand Managers "Love Its" TV

Many pharma marketing experts wonder why pharmaceutical marketers spend approximately 70% of their DTC advertising budgets on expensive TV advertising when they might get better bang for their bucks advertising through other channels such as the Internet.

Whether or not you agree with that, there's one indisputable factor about TV advertising to consider: the opportunity for brand managers to play at being directors, mingle with the stars, and even to have a "cameo" part in the production.

A good example of that is a disease awareness campaign called Are You Serious?TM, launched by Johnson & Johnson's wholly-owned Centocor Ortho Biotech division. This was described in a JNJBTW Blog guest post (here) by Craig Stoltz, Director, Product Communications, Immunology, Centocor Ortho Biotech Inc.
BTW, J&J IS serious about trademarking "Are You Serious?" Here's the result of a trademark search I performed (click on image to enlarge):

According to Stoltz, the "renowned Saturday Night Live actor and comedian, Jon Lovitz" called HIM -- not the other way around -- to pitch the public awareness campaign. Apparently, Lovitz suffered from severe plaque psoriasis for a decade until he found a dermatologist "who knew what the hell he was doing" (according to a song supposedly written by Lovitz as part of the TV campaign. Find it here; see screen shot below).

I guess it's feasible that Lovitz would pick up the phone himself to call a product manager (er, excuse me, I mean "Director, Product Communications").

According to Stoltz:
"The campaign is a collaborative educational effort between Centocor Ortho Biotech Inc., maker of two treatments for the management of moderate or severe psoriasis, and the National Psoriasis Foundation (NPF), starring Lovitz. It aims to raise awareness about this autoimmune condition and motivate patients to speak with a dermatologist about how to effectively manage their symptoms. That’s what Lovitz did less than a year ago, and he couldn’t be more passionate about sharing his positive experience with others to let them know they absolutely can take control of their disease."
Stoltz also admitted that he made a cameo appearance in one of the "behind-the-scenes footage and blooper videos."

Unfortunately, I opted NOT to view the "behind-the-scenes" videos because it requires registration. Ever since I began covering the issue of online privacy related to healthcare marketing, I am a little afraid to give away personal information to a pharmaceutical company (see "FTC Issues Privacy Report Recommending 'Do Not Track' Option").

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

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

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

Also today, privacy wonks are meeting in Washington, DC at the National Press Club conference "The Future of Online Consumer Protections." Topics for discussion include:
  • Protecting consumers while they surf the web: How to make a "Do Not Track Me" list work and other ideas.
  • How costs can be cut with electronic medical records while still maintaining patient privacy.
  • Is online health and drug marketing deceptive? Does it invade consumers' privacy?
One of the people presenting at that meeting is Jeff Chester, Founder and Executive Director of the Center for Digital Democracy (CDD). CDD and other privacy groups recently submitted a brief to the FTC citing "unfair and deceptive" online health and drug advertising practices (see, for example, "Center for Digital Democracy Challenges FTC to Reign In Online Pharma Marketing" and here).

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


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


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

BlueCava and other companies are developing "digital fingerprint technology to identify how we use our computers, mobile devices and TV set-top boxes," according to this Wall Street Journal article. Here are some excerpts:
Device fingerprinting is a powerful emerging tool in this trade. It's "the next generation of online advertising," Mr. Norris says.

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

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

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

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

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

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

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