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

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

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

You can access the PMCPA "informal guidance" here.

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

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

Regarding Twitter, PMCPA has this to say:

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

"Using twitter to alert health professionals about the publication of a study on a medicine is likely to be considered promotion of that medicine."

I interpret that to mean that Tweets such as the following from Boehringer Ingelheim (BI) may not pass muster with the Brits:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

PhRMA Statement on FDA Social Media Guidance Delay

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

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

To highlight that frustration, on April 1, 2011 (April Fools Day), I created a bogus PhRMA Statement, which included these memorable lines:

"Due to FDA’s limited resources and an increasing workload, FDA should seek out help developing social media guidance. PhRMA intends to continue to serve as a constructive partner in that regard. So why not give us a call or tweet us? We’ll be happy to draft some guidelines tout de suite."

and

“FDA says it wants the draft guidances ‘well thought out’ when they are issued. I mean, how difficult can it be? PhRMA Intern will be returning after the Spring semester is over and we can assign her to the project."

and

“FDA’s failure to act in this matter is a slap in the face of the pharmaceutical industry, which urgently requires social media guidance. ‘Let's Build Something Together’ is a famous tag line from Lowe’s Home Improvement. That sums up our position with regard to building FDA social media guidance as well."

The joke was successful as far as April Fools go and PhRMA had to act fast to contain the media's confusion. Christian Clymer (@CCatPhRMA), Social Media Lead for PhRMA, tweeted this in response to my post:

"Have you been fooled? See @pharmaguy April Fool's joke and PhRMA's real statement here... http://bit.ly/gEqjyz"

The link in his post leads to another note on PhRMA's blog:

April Facts v. April Fool's

by Kate Connors on 4/1/2011

Perhaps you’ve seen John Mack’s April Fool’s post that says he’s gotten a copy of PhRMA’s “statement” on the Food and Drug Administration’s delayed social media guidelines.

Mack’s post, which presents a fictitious statement, has made the rounds this morning, underscoring the immediacy of social media.

Here is our actual statement, released yesterday.

Go ahead and read PhRMA's ACTUAL statement. I think if PhRMA allowed itself to speak frankly, the real PhRMA Statement would have closely resembled my April Fools version. Now that April Fool's is over, I have removed the fake statement from this blog. See you NEXT April 1!

Pfizer is Responsible for 18% of My Spam Email!

This @pfizer_news tweet recently came to my attention:

"Pfizer, MHRA and partners anti-spam investigation FB page: http://on.fb.me/g5ULdX #realdanger"

I have been following Pfizer's campaign against counterfeit drugs for some time (see, for example, "Was a Rat Harmed in the Filming of This Pfizer Commercial?"). This "anti-spam investigation" is the latest phase of that campaign.

The Facebook page offers the report "You've Got Life-Threatening Mail" (find it here), which summarizes a study that involved 65 members of the public who volunteered to donate all their spam emails to the security teams at Pfizer and the MHRA (Medicines and Healthcare products Regulatory Agency -- UK's version of the FDA).

According to the introduction of this report "Spam – or unsolicited mail – is a common way fraudsters target members of the public with black market medicines. In fact, nearly 25% – that’s 15 billion messages – of all spam emails advertise medicines."

"Gareth" -- just one of the "Spam Donors" (watch out for typos there!) -- received 87 spam emails, of which 18% offered medicine. Poor "Dawn" received 228 spam emails, 9% of which offered medicine.

I decided to look in my own spam folder to see if I received any offers for Rx products. That folder currently contains over 4,000 emails (1 week's worth). I searched this folder for any email that mentioned "cholesterol" and found about 27:

I picked one with the subject line "Cholesterol is not just a number." Here's how that message looked:

I wanted to "GET THE FACTS," of course, so I clicked on that and here's the Web site that link lead me to:

The first item on the list -- "Learn About Cholesterol and a Cholesterol-Lowering Treatment" -- brought me to (you guessed it!) this LIPITOR Web page:

It took me a few clicks, but I found that Pfizer is one of those companies responsible for some (OK, maybe NOT 18%) of the SPAM email that I get!

It's ironic that Pfizer is trying to alert consumers about the dangers of spam email when they themselves are responsible for some of this spam. Of course, LIPITOR is not a dangerous counterfeit medication that is offered without a prescription via lipitor.com. Technically, therefore, Pfizer's spam would not qualify to be included in its report on "Life-threatening Mail." But it's still SPAM paid for by Pfizer!

I did a little more investigation to see if I could find out where my spam cholesterol email was coming from.

In the box at the end of the email is a "dotmedia" logo. That lead me to this site. But a note at the bottom of my spam email said "You are receiving this email from InterG Media." The top Google search result on "InterG Media" lead me to this WHOSIS domain registration data:

REGISTRANT CONTACT INFO
InterG Media
Domain Admin
1154 N. Sycamore Ave.
Suite 11
Los Angeles

BILLING CONTACT INFO
Adknowledge
Domain Admin
4600 Madison Ave.
1000
Kansas City

I ignored the REGISTRANT CONTACT and went straight to BILLING CONTACT INFO to find "Adknowledge," the entity that pays the bills. On its website (here) I discovered that Adknowledge claims to be the "leading long tail marketplace." Here's more "About" them:

"Adkowledge, the fourth largest advertiser marketplace, specializes in performance-based marketing solutions utilizing its powerful predictive technology and completely anonymous consumer response patterns to connect advertisers with consumers across multiple channels, including email, search, domains, and social networks. With over 60 terabytes of anonymous consumer behavior data, our proprietary targeting systems run over 20 billion calculations per day to determine what ad to show to each consumer. Over 10,000 advertisers use the Adknowledge ad network to promote their offers."

OK. From this, here's how I see Pfizer being a perpetrator of SPAM.

Obviously, the money to pay for my SPAM email has to come directly or indirectly from the marketers of the products advertised, which includes LIPITOR/Pfizer. I don't think Pfizer is paying InterG Media, the entity that supposedly sent me the email. InterG Media is probably just the technical geniuses behind Adknowledge's "predictive technology." No, someone hired Adknowledge -- maybe it was Pfizer itself or maybe it was a "media buyer" hired by Pfizer (or its LIPITOR ad agency of record) to send ads to consumers via the Internet.

What's the lesson learned? When you get SPAM email -- "threatening" or not -- you have to find the "long tail" back to who pays the piper. As Deep Throat said "follow the money."

New PhRMA Survey of Physicians: Are Sales Reps as "Useful" as PhRMA Wants Us to Believe?

"New Survey Emphasizes Value of Biopharmaceutical Company Engagement With Healthcare Providers" is the main point PhRMA (Pharmaceutical Research and Manufacturing Association - the industry trade association) emphasized in its press release (here) regarding a survey of physicians it sponsored. PhRMA also pointed out that nearly 9 out of 10 physicians considered company-sponsored peer education programs to be "up-to-date, useful and reliable."

That's good news for pharmaceutical marketers who spent $24 billion between October 2009 and September 2010 on physician-targeted promotional spending, not including nearly $1 billion on continuing medical education (more data on promotional spending will appear in a Pharma Marketing News article to be published later today). It's good news because the survey justifies devoting the bulk of that promotional spend to support physician detailing by sales reps.

Of course, it's always educational to go beyond the PR and the trade publication stories that merely rephrase the PR (eg, this story) to learn something new, even some things the drug industry may not want you to learn.

For instance, look at this survey result that PhRMA doesn't mention:

What I notice is that only 22% of physicians surveyed said that patient access to the care they need is "working best." There is some survey results interpretation issues here, but it seems that access to care may be a problem in the US according to physicians. And without access to care, everything else -- including the value of medicines, the quality of care in general, and the value of pharmaceutical sales reps -- means nothing. Of course, "access to care" is probably a physician buzz-phrase related to the shortcomings of "managed care" and even "Obamacare."

The very first sentence in PhRMA's press release emphasizes that "Nearly eight out of 10 physicians view pharmaceutical research companies and their sales representatives as useful sources of information on prescription medicines." What PhRMA does NOT say, however, is more telling. Take a look at this survey result:

What I notice is 38% of physicians find Web-based sources of medication information "very useful" versus 26% who find sales reps very useful for that information. Hmmm... either sales reps are not doing their job as well as the Web or maybe they are doing their jobs TOO well -- ie, providing company-sanctioned and biased information rather than information physicians think is useful. Or you could look it another way -- maybe docs are finding a lot more useful "off-label" information on the Web (and CME, which ranks #1?) -- information they technically cannot get from sales reps.

As with any survey, it is difficult to interpret the results of this survey, which allows for all sorts of spins. You can find the entire survey results attached to this Pharma Marketing Forums post.

Adverse Event Reporting -- Pharma Puts Profits Before Patients. A Missed Opportunity

By now you should have heard that the Supreme Court recently ruled that investors can sue pharmaceutical companies for failing to disclose reports of adverse events even if the evidence is not "statistically significant" (see "Supreme Court Allows Investors to Sue Pharmacos Over AE Reporting Lapses").

In a brief to the court, PhRMA (the US pharmaceutical trade association) said "A collection of adverse event reports that is not statistically significant does not permit a reasonable inference that a particular medicine actually caused the reported adverse event" (the brief is attached to the post cited above).

But what is "statistically significant?" According to PhRMA, "The statistical significance standard requires disclosure only once a correlation between an adverse event and the subject product can be reasonably inferred to be causal. It is only at that point that a manufacturer or regulatory body might react to adverse events, that a medicine’s sales would be threatened, and that a rational investor might consider this information in making investment decisions."

"Writing for the unanimous court," NPR reports, "Justice Sonia Sotomayor said that medical researchers and the FDA often reach initial conclusions based on evidence that is not statistically significant."

"The decision will make compliance with the securities laws more difficult" for corporations, said James Martin, who filed a brief in the case on behalf of lawyers who represent corporations.

The decision will also make it more difficult for pharma marketers to engage in the social media realm, where the adverse event boogey man has often been cited as an excuse for not engaging consumers about product issues.

When the adverse event reporting issue comes up during industry conferences such as this week's CBI's iPharmaConnect, there are always pharma people in the audience who wish their companies would embrace adverse event communication with consumers/patients as a way of supporting the users of their products. During my panel discussion -- "Utilization of Social Media -- How Far Is Too Far" -- one pharma employee in the audience had this to say:

"I think as an industry that we should really turn this [social media] adverse reporting [issue] on its head and look on it as an INCREDIBLE opportunity to really engage with the ultimate end user who is really the most important person [my emphasis, I think] and use it as an opportunity to find out WAY more than we ever do about how [our products] really affect their lives. ...I think this [pharma aversion to dealing head-on with AER in social media] is EXACTLY why people don't like the pharma industry -- because we're always doing things that are SO secret -- 'Oh, we can't talk about that.' -- it's ridiculous! We save people's lives and we should be ENCOURAGING [patients] to tell us what's going on and how these medicines are affecting their lives. I just think it's a missed opportunity."

Her statements were followed by immediate, spontaneous applause!

We have been told by our pharma marketing colleagues that the fear of lawsuits initiated by patients have prevented them from discussing adverse events in open forums. But it appears that the lawsuits pharma fears the most are NOT from disgruntled patients, but from disgruntled INVESTORS! That fear runs all the way up to the top of the organization; ie, the CEO, who is rewarded based upon stock price performance, not how well the company services patients.

Long gone are the days when a pharma CEO can truthfully say:

"We try to remember that medicine is for the patient. We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if we have remembered that, they will never fail to appear. The better we have remembered that, the larger they have been." -- George Merck - Founder of Merck & Co Inc.

Taro Pharmaceutical's "Bag O' Glass" Moment

I don't know who's "stupider" -- Taro Pharmaceutical, which published an OVIDE lotion branded comic book for kids without including warnings or the FDA, which sent the company a notice of violation letter because it did not include warnings such as "OVIDE Lotion is flammable?!"

Holy cow! Flammable?! Even with the warning, Taro should never promote this product in a  comic book aimed at kids!

It sort if reminds me of the Saturday Night Live "Bag O' Glass" skit featuring toy manufacturer Irwin Mainway, played byDan Aykroyd and Consumer Reporter played by Candice Bergen.

Consumer Reporter: So, you don't feel that this product is dangerous?

Irwin Mainway: No! Look, we put a label on every bag that says, "Kid! Be careful - broken glass!" I mean, we sell a lot of products in the "Bag O'" line.. like Bag O' Glass, Bag O' Nails, Bag O' Bugs, Bag O' Vipers, Bag O' Sulfuric Acid. They're decent toys, you know what I mean?

See the video of the skit on Hulu here.

Hat Tip to this Pharmalot story where you can read more about this.