Tuesday, May 29, 2012

AZ Posts "Reminder Drug Ad" to Its Corporate Blog

Last week I reported that AstraZeneca (AZ) posted an ad for CRESTOR on its "AZ Health Connections" corporate blog (see "AstraZeneca's Timely CRESTOR Branded Blog Post: Did It Violate Its Own Policy?"). The post included the indication for CRESTOR and also the "Important Safety Information" (ISI) that is required by the FDA whenever a drug company talks about a brand and its approved indication.

I wrote about that only because it was the first time -- to my knowledge -- that a pharma corporate blog promoted a branded product and I wondered if such posts violated AZ's own posting policies (turns out that it may or may not depending upon what you mean by "may" -- see the post for details).

Today, I noticed an AZ Health Connections blog post that talked about another AZ drug - ARIMIDEX, which is approved for "adjuvant treatment (treatment following surgery with or without radiation) of postmenopausal women with hormone receptor-positive early breast cancer."

This time, however, the post (find it here; see screen capture above) did NOT mention the approved indication. It is, by FDA definition, a "reminder ad." According to the Pharma Marketing Network Glossary:
Reminder advertisements are identified as an exemption to the advertisement regulations, including provisions to provide a brief summary. Reminder advertisements " . . . call attention to the name of the drug product but do not include indications or dosage recommendations for use of the drug product. . . . and, optionally, information . . . containing no representation or suggestion relating to the advertised drug product." Reminder advertisements cannot make a representation about the product or suggest a use for the product.
The AZ Health Connections post does "call attention to the name of the drug," but it also directs readers to ARIMIDEX Direct, which is a program that "allows eligible patients to receive ARIMIDEX delivered to their homes for $40 a month, including shipping and handling." Sounds like a good deal, although I did not investigate what the eligibility requirements were.

AZ deserves credit for reaching out to the online community to learn more about how it can make its drugs more accessible. Recall that AZ was the first pharma company to host a Twitter chat "to raise awareness about helping patients save money through prescription savings programs" (see "OMG! AstraZeneca Hosts Twitter Chat & World Does NOT End!").

PhRMA "forbids" Reminder Ads, But Not on Internet!
AZ's post raises some interesting questions regarding the promotion of Rx drugs on the Internet that neither the FDA nor the pharma industry has addressed. For example, PhRMA's "Guiding Principles for Direct-to-Consumer Advertising" (here) prohibit reminder ads on TV but NOT on the Internet:
Principle #10: "DTC television advertising that identifies a product by name should clearly state the health conditions for which the medicine is approved and the major risks associated with the medicine being advertised." [Alos see "Reminder Ads - Pharma's Dodo?"]
AZ, I believe, is a signatory to these voluntary guidelines. Since these guidelines only apply to TV advertising, AZ is not in violation. It's still the "wild west" on the Internet with regard to reminder ads; i.e., It's perfectly fine to run "reminder ads" on the Internet. This is usually the case when pharma companies buy Adwords (paid search ads) from Google, especially after the FDA came down on Adwords that included the indication with the brand name.

Another interesting issue is how pharma companies can manipulate "natural" (aka "organic") Google search results to display what is essentially a branded product ad that includes the brand name and indication, but no ISI.

Search Google for "arimidex" as I just did and you will find this:

The #4 (or #3, depending on how you count) search result leads you to the home page of the www.arimidex.com Web site. Note that the search result looks like an ad with copy that mentions the indication of the drug: "Learn about IN YOUR CORNER, an online breast cancer support resource for women with early breast cancer and the people who care about them."

How did that copy get there? Simple, AZ included the following "meta tags" in the "header" of the HTML code that generates the home page:

Google mindlessly reads the META NAME tag to display the description of the site in the search result. The information contained in that tag, of course, was written by AZ with the full realization that a Google search will include it in the search result. From there, it is only necessary to ensure that the site gets good placement in the natural results list and BINGO! You've got a branded "ad" that mentions the drug name and the indication WITHOUT the required ISI.

P.S. The Arimidex search result shown above may actually be what's called "paid inclusion," which refers to a sponsored "organic" search result (see, for example, "Paid Inclusion: Too Hot for Pharma Marketing?").

Sunday, May 27, 2012

"Shoe" Comic Strip Spoofs Pfizer's Chantix (unbranded) Side Effects

My Sunday newspaper comics section prominently features the "Shoe" comic strip on the front page. It's a favorite of mine. Today's Shoe spoofs the side effects of Rx drugs -- specifically a smoking-cessation drug. Although it doesn't mention any brand names, Chantix is the only non-nicotine drug approved by the FDA for smoking cessation currently available by prescription.

Here's the comic, which I pinned on my "Fun Pharma Images" Pinterest board:

According to the Shoe web site "The strip's namesake, Shoe, is based on legendary North Carolina journalist Jim Shumaker, Jeff MacNelly's first newspaper boss. P. Martin Shoemaker is a grouchy, cigar-smoking, newspaperbird with a tough side and an even tougher other side."

Even tough birds, it seems, can suffer drug side effects. Shoe mentions "chest pains, bad breath and a hacking cough" as his main side effects. This is funny in context of the quit smoking indication but Chantix has been linked to a much more serious side effect: suicide. For more on that see "Chantix May Be More Dangerous Than Smoking!" and the chart below:

Of course, Shoe may be taking some other drug such as a generic version of Zyban.

The question remains: would Shoe be better off smoking his cigars or taking a medication to quit?

I'm not a cigar smoker, but I wouldn't inhale cigar smoke if I were. But there's the secondary effects of inhaling the smoke that's released into the surrounding air by cigars.

In any case, Shoe would be a terrible boss to work for whether he quit smoking or not!

Friday, May 25, 2012

Is There a Doctor in the House? FDA Bad Ad Program is Designed for You. Not So Much for Me!

Two days ago, I sent an email to FDA's "Bad Ad" program (email addr: BadAd@fda.hhs.gov) to cite a Pfizer iPhone App as a "Bad Ad" (see "Recipes 2 Go: Pfizer's LIPITOR-Branded iPhone App. Is It an Ad FDA Should Review?" for background). For the record, here's a screen shot of the email I sent (click on it for an enlarged view):

A minute later, I received an acknowledgement email from the FDA that started with "Thank you for taking the time to alert us to potentially misleading promotion," but ended with "If you are not a healthcare provider, please refer to the OPDP website for instructions on how to submit a complaint, or call (301) 796-1200." I was confused, so I called the number and left a message.

Today, Olga Salis, OPDP Senior Project Manager, called me back to explain the Bad Ad complaint process. It appears that "healthcare professionals" (i.e., mostly physicians) can submit complaints about ads via email whereas ordinary citizens such as myself MUST use snail mail; i.e., send a physical letter to FDA/CDER/OPDP, 5901-B Ammendale Rd, Beltsville, MD 20705-1266. This distinction is not clear from the information provided on the Bad Ad page here.

It's OBVIOUS that the FDA does not want to be bothered or flooded by consumer complaints because it is not making it easy for consumers to submit complaints. Who knows if FDA would have done anything with my complaint had I not called. As it is, it may take OPDP THREE months to respond or take action on my complaint, "if it has merit."

NOTE: FDA receives complaints from three sources: Healthcare Professionals (HCPs), Consumers, and "representatives of regulated industry" (ie, pharma companies ratting out their competitors). The "pharma" group of complaints was the most credible -- 58% of those complaints were deemed worthy for "comprehensive review," whereas 46% of HCP complaints and only 21% of consumer complaints made the cut (see figure below and also here):

I will followup with a written letter sent to OPDP. However, I encourage any healthcare professional reading this blog to download the Pfizer iPhone app in question and if you agree with me that it is worthy of a "bad ad" complaint to the FDA, then all you have to do is send an email to BadAd@fda.hhs.gov. Easy for you, not so  much for me :-(

Thursday, May 24, 2012

Online Physician Communities Hold Promise, But Do They Deliver?

Doctors 2.0 and Pharma Marketing News is currently running the "Exploring the Doctor 2.0" survey (find it here), which asks respondents about the impact of New Technologies on healthcare, a subject that is right now being discussed by the "Online Health Care Professional Communities" panel at the Doctors 2.0 & You Conference in Paris, France.

I will be reviewing in more details the results of this survey in the upcoming issue of Pharma Marketing News, but will give you a glimpse of the results of the first question, which asked respondents to rate the importance internet tools and services in improving healthcare. The results are shown in the following chart:

Over 80% of respondents (N=54) said that online professional communities were very useful or essential tools for improving healthcare. Close behind that were mobile apps for professionals and patients. The chart shows a comparison between EU (yellow line) and North American (red line) respondents.

However, According to a QuantiaMD and Care Continuum Alliance 4,033-clinician study, 28% of clinicians access online physician communities. “A notable 92% of physicians are interested in interacting with colleagues in online professional networks to learn from experts and peers, discuss clinical issues and share practice management challenges. However, more than 70% of physicians say patient privacy issues would hold them back from using these networks, and two-thirds are worried about liability issues. Lack of time and issues with compensation are also areas of concern.” Chart:

Note: N=4032 for all responses except physician communities, which only includes respondents with no prior QuantiaMD connection (N=854). Source: QuantiaResearch www.quantiamd.com

For more about this discrepancy (highly rated importance of physician communities and actual low use of them by physicians) see "Physician Participation in Peer-to-Peer Social Media Sites: Why Is It Less Than Expected?" Use discount code 'P2Pfree' to get it free.

Wednesday, May 23, 2012

Recipes 2 Go: Pfizer's LIPITOR-Branded iPhone App. Is It an Ad FDA Should Review?

I just learned that Pfizer has developed an iPhone/iPad app that promotes LIPITOR, the drug company's off-patent lipid-lowering drug. The app is "Recipes 2 Go." It is the first pharmaceutical app that I know of that promotes a prescription drug.

Here's what the promo screen on iTunes looks like (click on it for an enlarged view):

The description -- shown here in its entirety -- mentions LIPITOR and the FDA-approved indication, which is managing high cholesterol.

Is This an FDA-regulated Drug Ad?
My question: Does this iTunes page qualify as an prescription drug ad that must comply with FDA regulations regarding fair balance (ie, Important Safety Information or ISI)? If it does qualify, then it violates FDA regulations because the page does not include ANY fair balance or a link to the full prescribing information.

Did Pfizer submit this page to FDA for regulatory review? Did it submit the page to its own MLR (medical/legal/regulatory) people?

I downloaded the app to my iPhone and found the side effect/fair balance information plus a link to the "full prescribing" information on the very bottom of the "About Us" screen. Here's what the screen looks like:

Only when you scroll down to the next screen do you see the notice "Scroll down to see Important Safety Information," which appears about 14 screens further down! Whew! That's a lot of scrolling!

The multi-page End-User Agreement (dated April 20, 2012)  should be read carefully. For one thing, it states that "NO STATEMENTS MADE IN THIS SOFTWARE HAVE BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION."

To which I say, Why Not? The FDA should definitely take a look at this app and decide if it complies with regulations.

Because this app does not present the ISI where it can easily be found (and not at all on the iTunes promo page), I gave it only a single star rating on iTunes :-)

Shire Seeks to Maintain YouTube "Loophole" in FDA's Draft Guidelines for TV Ads

FDA has received several comments from the pharmaceutical industry regarding the agency's "Draft Guidance for Industry Direct-to-Consumer Television Advertisements." In past posts I reviewed comments from PhRMA (the drug industry U.S. trade association) and Sanofi (see here and here). In this post, I report on comments made by Shire (find Shire's comments here).

Shire, like Sanofi, Novo Nordisk and Boehringer Ingelheim (BI), believes that submission of a final recorded version of a TV ad for FDA approval prior to being aired would be "burdensome." Shire specifically cites the optional two-step process FDA suggested; i.e., first submit an annotated storyboard and then a final recorded version of the ad. "This sequential two-submission process would double the time and resource burden on sponsors as well as the Agency," says Shire.
Serial OPDP Review Blues
BI also mentioned the "burden" of a two-step process in its comments to the FDA (find them here). But BI was referring to the need to resubmit a new version of the ad after receiving critical comments from the FDA concerning the first version submitted for review. 
"BIPI is concerned with the incremental time and cost that would be incurred by sponsors to routinely produce and submit multiple broadcasts for the purpose of OPDP [FDA's Office of Prescription Drug Promotion] pre-dissemination review," says BI. "BIPI is similarly concerned that the repeated submissions of storyboards to capture serial sets of OPDP suggestions (i.e., the submission of modified storyboards for advisory comments following integration of initial advisory comments) would greatly increase the time, if not the cost, of producing DTC broadcast ads." 
BI says that it "behooves sponsors to ensure storyboards submitted for advisory comments are representative of the final ad and to ensure that the Agency's comments are incorporated into the filmed version." In other words, BI suggests FDA just look at storyboards and trust that the sponsor will create a final "filmed" ad that is revised according to FDA comments.
Shire, however, was the only pharma company to point out a "loophole" that I revealed on Pharma Marketing Blog in March (see "A Loophole (?) in New FDA Guidance on Pre-Dissemination Review of TV Direct-to-Consumer Ads"). In that post, I said:
"FDA does not define what exactly it means by 'dissemination.' Perhaps it has defined this term elsewhere in it regulatory archives, but I assume in this case it means airing the ad on mass market TV. Does that include uploading the video to YouTube? A drug company could upload a video of a pre-approved ad to YouTube at the same time that it submits the video to FDA for 'pre-dissemination' review. The video can then be embedded in the drug.com website or promoted via Twitter."
Shire pointed out the same lack of clarity in its comments. "...there has been increasing availability and use of vehicles other than broadcast TV to present video advertising, such as on-demand viewing via the Internet," says Shire. "Shire recommends that FDA affirm that the scope of the guidance includes only DTC advertisements disseminated through broadcast television."

FDA and the drug industry continue to see no need to issue any mandatory or even voluntary guidelines specifically for drug promotion via the Internet. Shire points out, for example, that there already is an "advisory review process" that applies to video advertisements disseminated through "other viewing platforms' (i.e., the Internet). That process (see here) says "a sponsor may voluntarily submit advertisements to FDA for comment prior to publication."

However, if "dissemination" is defined according to Shire's rules, then it is possible for a drug company to run a video ad on YouTube months before it airs the same ad on TV without having to submit anything to the FDA for review -- the current "advisory review process" that Shire refers to is voluntary.

As part of that process (e.g., submission of static storyboards for video ads), FDA estimates that "approximately 2 hours on average would be needed per submission, including the time it takes to prepare, assemble, and copy the necessary information." Compared to that, the creation of "final filmed" versions of TV ads is indeed a significant burden on sponsors. However, since FDA's new guidelines are specifically aimed at products with significant safety concerns, it "behooves" the drug industry to carry that "burden" in the interest of patient safety, IMHO.

Tuesday, May 22, 2012

Sanofi Says Proposed FDA DTC Guidelines Would Effectively Kill TV Drug Ads

PhRMA is itching to challenge FDA's authority to regulate DTC advertising in front of the Supreme Court, arguing that recent "Draft FDA Guidance on PreDissemination Review of TV Direct-to-Consumer Ads" (find it here) violates the Free Speech Clause of the First Amendment because pharmaceutical marketing is a form of free speech (see "PhRMA Demands that FDA 'Cabin' Its Discretion to Regulate DTC Ads").

Sanofi, on the other hand, in a comment submitted to FDA (see here) argues that "the process presented in the draft guidance would potentially require the sponsor [ie, Sanofi and other pharma companies] to cease the use of TV ads as a vehicle to educate consumers due to significant production challenges as a result of the draft proposed process."

The "process" that Sanofi is talking about is the requirement to submit a "final recorded version [of the ad] in its entirety." Sanofi is concerned that if the ad needs to be changed -- reshot and re-edited -- as a result of FDA pre-review, it be too costly and "resource intensive" for the sponsor.

Not all ads, however, will require FDA review before airing (see "Focus on Drug Safety Communication & TV DTC Advertising" for details) and it is not clear how much it would actually cost to redo the production to comply with FDA comments. Sanofi should have included some specific estimates of these costs and "resources" to bolster its case.

Sanofi offered a compromise. Instead of submitting a "final recorded version" of the TV ad "in its entirety," Sanofi suggests that sponsors submit an "annotated storyboard or animatic [animated?] version of the advertisement."

FDA already reviews storyboards submitted prior to ads being run. In at least one case, however, a violative ad was aired months after FDA had a storyboard in its possession. Only after the ad had run its course did the FDA issue a notice of violation (see "FDA and YAZ: Is FDA Helping Marketers Work Around Regulations?").

Sanofi also submitted a comment regarding FDA's requirement for "verification that a spokesperson who is represented as a real patient [in a TV ad] is indeed an actual patient." Sanofi asked that FDA clarify what type of verification would be needed. Would a "signed testimonial from an actual patient" be enough?

Snaofi may be planning to use more real patients in its TV ads as have other pharma companies (eg, Pfizer use of real patients in Chantix TV ads). I've documented one instance where Sanofi has used a real patient in a video ad on YouTube (see "Method Acting for Real Patients Who Play Themselves on Pharma YouTube Channels") but do not recall any TV ads for Sanofi products that used real patients.

Regardless of what verification FDA requires for TV ads, the guidelines only apply to TV ads and NOT to ads that run on YouTube. Hence, although these new guidelines may "kill" TV drug ads, they may be a boon for YouTube ads such as the Sanofi YouTube video mentioned above.

Monday, May 21, 2012

PhRMA Demands that FDA "Cabin" Its Discretion to Regulate DTC Ads

In a 20-page comment submitted to the FDA on May 14, 2012, the Pharmaceutical Research and Manufacturers of America (PhRMA), advised the FDA to "proceed cautiously and in a manner that fully protects the free speech rights of advertisers and patients" with regard to the agency's recent Draft Guidance for Industry on Direct-to-Consumer (DTC) Television Advertisements."

Recall that the Food and Drug Administration Amendments Act of 2007 (FDAAA) gives FDA the authority to ". . . require the submission of any television advertisement for a drug . . . not later than 45 days before dissemination of the television advertisement" (see "Draft FDA Guidance on PreDissemination Review of TV Direct-to-Consumer Ads").

In its comments, PhRMA uses the word "cabin" as a verb, as in "clearly defined standards that cabin the reviewing official's 'unbridled discretion'" and "objective standards to cabin FDA's discretion."

Why does PhRMA want to banish FDA to a "cabin" in the woods as far it's discretion to pre-review DTC ads is concerned?

PhRMA is itching to challenge FDA's authority to regulate DTC advertising in front of the Supreme Court, which is cited several times in PhRMA's comments. For example, PhRMA reminded the FDA (as if that was necessary) that the Supreme Court "recently affirmed that '[s]peech in aid of pharmaceutical marketing .... is a form of expression protected by the Free Speech Clause of the First Amendment.' Thus," says PhRMA, "when the FDA restricts the speech of pharmaceutical manufacturers and other regulated entities, the restrictions are subject to scrutiny under the First Amendment."

But the Supreme Court Court is not likely to scrutinize "informal guidance," which is not legally binding. Therefore, PhRMA is pushing the FDA to issue regulations, which carry the weight of law. "Regulations that unduly burden truthful, non-misleading commercial speech about a lawful product," says PhRMA, "hinder consumer choice ... and rarely survive constitutional scrutiny."

Of course, FDA wants to prevent "misleading" drug ads from being aired. Right now, however, it can only cite ads as "misleading" AFTER they have already been aired.

I'm not going to delve into the legal arguments that PhRMA puts forth. You can read them yourself here. I just find it interesting that the drug industry is pushing FDA to stop issuing non-binding guidances in this case as well as in the case of social media (see "WLF & Pfizer Ask Court to Block FDA Guidance on Social Media"). I also like how PhRMA uses "cabin" as a verb, hence the cabin image that accompanies this post.

Hat Tip to @AlecGaffney for alerting me to the publication of PhRMA's comments in the Federal Register, where "occasionally interesting reading [is] to be had."

Thursday, May 17, 2012

Drugs are Losing the Battle Against Heart Disease. Here's Why.

The percentage of the U.S. population taking at least one prescription drug during the past 30 days increased from 38% in 1988–1994 to 48% in 2005–2008. During the same period, the percentage taking three or more prescription drugs nearly doubled, from 11% to 21%, and the percentage taking five or more drugs increased from 4% to 11%. These data come from the CDC "Health, Unites States, 2011" report (find it here).

Meanwhile, the prevalence of heart disease, which is the leading cause of death in the U.S., remained steady from 1999–2000 to 2009–2010 among adult women in all age groups, and among men 45–74 years of age. Among men 75 years of age and over, prevalence rose from 39% in 1999–2000 to 45% in 2009–2010.

There goes my rationale for taking statins to lower my risk of heart attack! It seems that the drug industry is not as successful in improving our health as it claims to be.

And new drugs aimed at lowering the risk for heart disease currently being developed may be effective in achieving "surrogate endpoints" in clinical trials but not effective in reducing risk.

That was the takeaway from a new study published online recently in The Lancet. That study provided evidence that increasing the level of HDL ("good cholesterol") does not lead to less risk for heart disease (see "HDL hypothesis is on the ropes right now").

That's not good news for companies that are actively developing and testing drugs that raise HDL -- even if these drugs succeed in that goal they are not likely to help prevent heart disease.

There's lots of other interesting data in the CDC report. I've gathered my favorite charts into the infographic shown here (click here for an enlarged view).

Sunday, May 13, 2012

AstraZeneca's Timely CRESTOR Branded Blog Post: Did It Violate Its Own Policy?

It's unusual for a pharmaceutical company to mention a product by brand name on its corporate blog. It's even more unusual to mention BOTH the product AND its indication -- because that would be promotion regulated by the FDA. But AstraZeneca (AZ) has done just that on its "AZ Health Connections" corporate blog.

The majority of the post "New CDC data shows drop in number of adults with high cholesterol" submitted by Tom Hushen, AZ's External Communications Manager, talks about CRESTOR, AZ's anti-cholesterol drug. The post may have been ghostwritten for "Dr Philip de Vane, Executive Director of Clinical Development at AstraZeneca," whose name appears at the bottom.

After briefly citing the results of the CDC (Centers for Disease Control) study (see below) in the first paragraph, Hushen dedicates the most of the remaining 309 words of the 377-word post to CRESTOR as in:
"AstraZeneca applauds this progress and we are proud that when diet and exercise alone aren’t enough, prescription medications like CRESTOR® (rosuvastatin calcium) are able to help patients reach their cholesterol goals. In adults, CRESTOR is prescribed along with diet to lower high cholesterol and to slow the buildup of plaque in arteries."
Included in the post is the "fair balance" information required by law:
"CRESTOR is not right for everyone─like people with liver disease or women who are nursing, pregnant or may become pregnant. Tell your doctor about other medicines you are taking. Call your doctor right away if you have muscle pain or weakness; feel unusually tired; have loss of appetite, upper belly pain, dark urine, or yellowing of skin or eyes─these could be signs of rare but serious side effects. See www.CRESTOR.com"
Although this is not earth-shaking or in violation of any law that I know of, it nevertheless is the FIRST time a pharmaceutical company has promoted a prescription drug on its official corporate blog -- ie, talked about the drug's benefits.

It's even more interesting considering the AZ Health Connections "Comment Policy" seems to preclude any comments about specific products:
"We want to make sure AZ Health Connections provides a good experience for all visitors. Therefore, we want to keep the content focused on the specific topics being addressed. Comments that don’t directly relate to AstraZeneca or the topics currently being discussed, or comments or questions about specific products (whether or not AstraZeneca products) or ongoing legal or regulatory matters may not be published or may be removed."
Could it be that what's good for the "goose" (AZ) is not good for the "gander" (everyone else)? It seems that AZ has relaxed its comments policy, at least this one time. As proof of this, I submitted the following comment, which AZ published:
"I am one of those U.S. adults with high cholesterol that is having problems controlling it with just diet and exercise, which I don’t even try to do :-). But I am worried about taking powerful medicines such as CRESTOR because of the side effects that you mention."
AZ published that comment made by this "gander." It is the only comment published so far, so I have no idea if other people have submitted comments that were NOT published. Maybe Tony Jewell, Senior Director of External Communications at AstraZeneca US, will tell us. NOTE: Jewell received the coveted "Pharmaguy Social Media Pioneer Award" in 2011 (see here).
Note: In a personal email, Jewell said: "This post was reviewed, as are all others that mention medicines or disease states. There have been many on the blog, Twitter and Facebook." Upon searching the AZ blog site for other posts that mention CRESTOR, I could not find any post that mentioned the product name AND the disease state (high cholesterol) it is approved to treat. There were, however, a couple of posts that mentioned CRESTOR without its indication. 
Why did AZ do this at this time? It seems to be very opportunistic considering that it coincides with the release of CDC data that shows improvement to cholesterol levels for many Americans. Also, Pfizer just announced it is no longer promoting Lipitor (see "Pfizer Throws In the Lipitor Marketing Towel" and "Lipitor R.I.P. Infographic").

Obviously, now is a good time for AZ to ramp up the promotion of CRESTOR, as it is positioned to take over the number one (or virtually ONLY) statin TOP sales spot (see chart below):

It's also obvious that AZ wants to take some credit for the results reported by the CDC, which are summarized in the following "infographic" (creating infographics is a new obsession of mine):

Some interesting conclusions can be made from the data in this CDC report, which you can find here.

For one thing, women are not doing as well as men in terms of lowering their total cholesterol. This is especially true for women aged 60 and over. Women in that age group have consistently higher percentages of high total cholesterol than men.

The percentage of adults with low HDL cholesterol was higher for men (31.4%) than for women (11.9%).

Although the CDC does study the use of statin drugs by adults and breaks this down by sex and age (see top chart in the infographic), the CDC's analysis that is highlighted in AZ's blog post is based "only on measured cholesterol and does not take into account whether medications are taken."

That's too bad. It would have been interesting to see the correlation between statin use and lowered measured cholesterol.

More important than managing cholesterol levels, however, is whether or not statins actually improve health outcomes such as heart disease. There are results from clinical trials that indicate such a benefit, but how does that correlate with results in the real world?

Just curious.

Thursday, May 10, 2012

Pfizer Throws In the Lipitor Marketing Towel. Repercussions in Job Market Will Be Swift

Despite Pfizer's heroic and unprecedented effort to maintain Lipitor's market share after expiry last November and after spending "more than $87 million promoting the medicine, the world's biggest drug company is quietly giving up on its once-great cash cow for good because more generic versions will soon be going on sale" (see this Wall Street Journal story: "Farewell after all, Lipitor").

As I reported here on Pharma Marketing Blog on May 2 (see here), Pfizer's Lipitor co-pay card/PBM discount plan failed to meet its goal of maintaining a 40% share of the combined market for Lipitor and its generic equivalents for at least 6 months after generic brands are launched. As reported in the WSJ (op cit), Lipitor's U.S. market share is 33% after 5 months (more generics will come on the market after May 31).

Although Pfizer will say that its program was a succes, the program has not met its sales goal and is considered a public relations failure by some people in the industry. A pharmaceutical marketing VP attending a recent conference referred to my blog posts "Occupy Pfizer! Protest It's Deal to Block Sales of Generic Lipitor! #OccupyPFE" and "Do Drug Coupons Hurt Employee Health Plans and Ultimately Employees?"

But after spending more than $87 million promoting Lipitor in recent months, Pfizer officials told The Wall Street Journal that the company is "no longer negotiating new contracts to sell Lipitor to health plans, which are signing up to sell generic versions at far lower prices. The company recently stopped sending sales representatives to promote Lipitor to doctors and halted advertising in print, on television and online, which once commanded a $271.9 million yearly budget." Here's a chart showing Lipitor's direct-to-consumer (DTC) advertising budget over the past 9 years:

[Note the minuscule proportion allocated to "Internet" ad spending. I cannot see from this chart what the $ amount is!]

The elimination of $220 or so million in Lipitor DTC advertising will, I predict, result in a 3% drop in overall DTC advertising in 2012 compared to 2011 (see "Lipitor Holds Key to DTC Ad Spending in 2012"). But that is only the tip of the Lipitor marketing budget, which totaled over $660 million in 2010. Included in that number is marketing to physicians and samples (see here).

When that much money is taken out of the Rx brand marketing equation, there are bound to be repercussions within Pfizer itself and within marketing communications companies that provide services to Pfizer. Meaning, of course, jobs will be lost. Perhaps that correction has already occurred. Or perhaps there are more layoffs to come.

Tuesday, May 8, 2012

Have You Met Turbo & Scott? FTC May Want to Meet this eBook for Children Sponsored by Novartis

I just found this tweet from @Novartis:
"US only: Have you met Turbo & Scott? Visit http://t.co/yJDtSvhQ to read the TSC eBook or download Barks and Crafts"
At first, I thought this would be some kind of Rx branded Web site because it was for "US only," which usually means there's some direct-to-consumer (DTC) Rx product information on the site or closely linked to it. But there isn't any hint of a drug mentioned anywhere that I can find.

It's really a site designed for young children who have TSC, "which stands for three big and hard-to-pronounce words, Tuberous Sclerosis Complex."
NOTE: Novartis probably markets the only drug approved by the FDA for treatment of TSC (see press release). Hence, even though the drug is not referenced on this site, FDA may regulate the site as if it were marketing that drug. European regulators also may feel that the TSC site violates their regulations regarding DTC communications.
The eBook is beautifully illustrated and written in the simple language that a child would use. In fact, it's a story told by Turbo, the stuffed dog friend of Scott who is "a real boy and [Turbo's] best friend." Scott has TSC.

I've never heard of TSC before, but apparently, it is a pretty serious hereditary condition that can cause seizures and may require Scott and other kids with TSC to be examined and treated by as many as SEVEN different specialists: Neurologist, Ophthalmologist, Pulmonologist, Nephrologists, Psychiatrist, Cardiologist, and Dermatologist. That's a lot of "gists!" The ebook does a good job explaining to kids what these doctors do.

But what the site does NOT do well (IMHO) is comply with the U.S. Children's Online Privacy Protection Act (COPPA). COPPA "applies to operators of commercial websites and online services directed to children under 13 that collect, use, or disclose personal information from children." Such sites may not collect personally-identifiable information from children without the consent of parents (see COPPA FAQs).

The URL in the tweet above resolves to this URL: http://www.tuberous-sclerosis.com/patient/ebook/ebookhome.jsp which displays this page:

There is a notice from Novartis at the bottom of the screen, which states "Use of this website is governed by the Terms of Use and Privacy Statement. Copyright ©2012 Novartis Pharmaceuticals Corporation. All rights reserved."

The privacy statement clearly states that "Novartis will not knowingly collect, use or disclose personally identifiable information from a minor under the age of 13, without obtaining prior consent from a person with parental responsibility (parent or guardian)." However, any child (including me) can click on the "Send to Friend" tab and enter his/her name and email address as well as the email address of a friend:

Novartis says "The email addresses you furnish will be used solely to notify the recipient of the link to this page and that you have requested it to be sent. The addresses will not be retained or reused." Since the information is not "retained of reused," this "Send to Friend" feature may be eligible for the "one-time exclusion" allowed by COPPA.

However, another feature of the site allows children to send an email message directly to TSC.Story@novartis.com.

On that page Novartis says: "TSC.Story@novartis.com is to be used to show your interest in further information. We look forward to receiving your email. The personal email information you submit will be used to deliver information about TSC and the TSC eBook program only. By submitting your information you agree to receive information via emails. Please be assured that although we share your information with third parties who work for us on these activities, neither Novartis nor third parties working on our behalf will sell or rent your personal email information. You may unsubscribe at any time by clicking here and specifying Unsubscribe in the subject of the email."

This is clearly an attempt to collect personal information from the children at whom this site is aimed.

I've sent an email to TSC.Story@novartis.com requesting more information about TSC. I signed it "Johnny Mack." So far, I haven't received any response.

P.S. There's a bit of confusion about who is responsible for collecting personal information on the site. I found this statement: "The TSC eBook is sponsored by Novartis Pharmaceuticals Corporation. With the exception of www.TSCStory.com and www.FacingTSC.com, the websites mentioned in this eBook are independently operated and not managed by Novartis, which assumes no responsibility for any information they may provide."

Friday, May 4, 2012

Is 38 Hours Quick Enough to Respond to a Potentially Serious AE Tweet?

Subtitle: JNJ Responds to Adverse Event Reported Directly to @JNJComm via Twitter

There are probably more than 100 pharmaceutical company Twitter accounts such as @JNJComm, which posts news and information from Johnson and Johnson's Corporate Media Relations team (Devon Eyer - @DevonEyer - and Bill Price - @wtprice3).

With such a conspicuous presence on Twitter, I am amazed that I haven't noticed very many complaints from consumers directed at these accounts. I'm specifically talking about complaints that relate to adverse drug reactions. Pharma companies are deathly afraid of having to deal with such complaints via social media mostly because of the FTEs that may be required.

But, really, how big a problem is it? I haven't done a quantitative analysis, but I suspect that if @JNJComm gets one such complaint per month, that would be a lot.

This month, I noticed a complaint made to @JNJComm by @CapeFearPhoto (aka "Chad Heavilyarmed"). At 12:06 AM on May 2, 2012, @CapeFearPhoto tweeted:
"Hey @JNJComm Can we talk about #sideeffects from your Janssen Pharm products? Please? #stillvomiting #nightterrors #nothappy #NUCYNTA #FAIL"
About 20 minutes later at 12:21 AM, @CapeFearPhoto sent another tweet directed to @JNJComm:
"Seriously @JNJComm I know you guys are probably sleeping. Kinda wish I could. Let's chat about #NUCYNTA drug trial results and #sideeffects"
Yes, Devon and Bill were probably asleep, but @JNJComm did finally respond at 1:59 PM on May 3, 2012:
"@CapeFearPhoto Thanks for the message; we'd like to learn more about your situation. Please call 800-526-7736 or visit http://ow.ly/1LCBtn"
The link leads to Janssen Pharmaceutical's "Tweet Response" page, which was "last modified" on Apr 13 2012. This is the first time I've seen such a Web page. I wonder if other pharmaceutical companies have similar pages to which they direct Twitter users? The page informs visitors that:
"This is in follow up to your recent tweet regarding our product. As a pharmaceutical company, we are required to inform the Food and Drug Administration of any adverse experiences associated with our products. Therefore, our Global Medical Safety department would like to learn additional information about your experience and hope you will contact us at janssenmedinfo@its.jnj.com or at 1-800-526-7736."
At 2:20 PM on May 3, 2012, @CapeFearPhoto responded with this tweet:
"I will @JNJComm! #Nucynta gave more adverse reactions than anything I've ever taken and almost drove me to suicide. #horribleterriblebad"
I'm not going to get into whether or not this qualifies as a reportable adverse event. But it should be noted that the tweet was directed specifically to @JNJComm and that @JNJComm responded PUBLICLY via Twitter within 38 or so hours.

Perhaps JNJ could have responded sooner. After all, the "Tweet Response" page was available and the tweet that @JNJComm eventually sent out could have been a MLR pre-approved "boiler plate" response all ready to go. Or was it? Maybe it took @JNJComm so much time to respond because it never before received such a message and had to craft an appropriate response and get it approved before it could be sent!

Whatever, just another pharma social media first for me to document. Here's a screen shot of the relevant conversation for the record:

Obama's Executive Order Spurs Drug Industry to Cooperate with FDA to Ease Drug Shortages

This week marks the six-month anniversary of President Obama signing an Executive Order to help FDA in its efforts to prevent and resolve prescription drug shortages. Following the Executive Order, FDA sent out letters to drug manufacturers asking them to "voluntarily report to FDA if they saw the emerging potential for a drug shortage."

"I am both amazed and delighted to see the progress that’s been made," said FDA Commissioner Margaret Hamburg in a blog post (here). "Early notification to FDA of potential disruptions in drug supply has made a huge difference in our efforts -- and the numbers really tell the story [see chart below]."

"Since reaching out to industry, there has been a six-fold increase in early notifications from manufacturers," said Hamburg. "Also in that six month timeframe, we have been able to prevent 128 drug shortages, and we’re seeing fewer numbers of shortages occur – 42 new drugs in shortage reported in 2012, compared to 90 new shortages at this time last year. This data is a testament to how FDA exercises flexibility and discretion in much of our work on drug shortages and the importance of strong collaboration and constant communication with industry, health professionals, and patients."

According to the above chart, FDA projects that there will be only about 130 actual drug shortages reported in 2012 compared to 250 reported in 2011 and that FDA-industry cooperation will have prevented about 100 additional shortages. By FDA estimates, even if it didn't prevent any shortages, the number of drug shortages in 2012 would be about 230 compared to 250 in 2011. That is, FDA envisions the trend in drug shortages reversing with or without FDA intervention.

But with FDA and industry cooperation, there were only 42 new drugs in shortage reported in 2012, compared to 90 new shortages at this time last year.

Thursday, May 3, 2012

Pharma Support of CME Infographic

Pharma support of CME continues to decline, but at a slower rate.

"Other" Sources of Revenue (eg, registration fees, grants from gov't or independent foundations) have taken up the slack and then some so that 2010 revenue actually increased compared to 2009!

The distribution of CME income by source as a percent of the total looks more like the "old" days around the turn of the century.

A big surprise is the drop in percent of physicians opting to participate in online CME programs.

Source of Data: ACCME Annual Reports

Wednesday, May 2, 2012

Pfizer's Lipitor Co-pay Card/PBM Discount Plan Fails

Yesterday, an attendee at the Marcus Evans PharmaMarketing Summit here in Chicago asked if Pfizer's innovative plan to extend the life of its Lipitor franchise after patent expiration was a public relations failure. He was referring, in part, to my blog posts "Occupy Pfizer! Protest It's Deal to Block Sales of Generic Lipitor! #OccupyPFE" and "Do Drug Coupons Hurt Employee Health Plans and Ultimately Employees?"

Pfizer had hoped that its aggressive co-pay card/PBM discount plan would allow Lipitor to maintain a 40% share of the combined market for Lipitor and its generic equivalents for at least 6 months after generic brands are launched (see here). Today, I read in the Wall Street Journal that Pfizer 2012 first-quarter profit declined 19% (vs Q1 2011) as sales of Lipitor, tumbled 71% in the U.S.

"Global sales of the drug fell 42% to $1.4 billion, including $383 million in the U.S. The branded Lipitor's U.S. prescription market share has declined to just over 30%, according to analysts, as competing generic versions from Watson Pharmaceuticals Inc. and Ranbaxy Laboratories Ltd. have taken market share" (see here).

You could speculate that Lipitor sales would have dropped even further and faster if it were not for Pfizer's Co-Pay discount plan, which also involved pharmacists dispensing Lipitor even when a generic version was prescribed by the doctor.

Or you could say that the plan failed to meet its goal, ie, 40% of U.S. market sales. There's still a month or 2 before we reach the 6 month mark and sales of Lipitor can drop even further before then.