PhRMA Report on DTC: Everything's Coming Up Roses!

PhRMA has just released its second annual report on comments it has received regarding violations of its Guiding Principles for DTC Advertising (see "DTC Advertising Improvements Observed In Two New Reports").

PhRMA did a wonderful job of "white washing" or glossing over any negative criticisms with statements like the following peppered throughout the report:

"The comments on Principle 1 [DTC Ads should be educational] were both positive – with many patients having favorable reactions to the educational component of an ad – and negative – primarily with regard to specific actors used in the advertisement."

"Many consumers were appreciative of the information provided while others stated confusion about the details of the advertisement and asked for further clarification. All companies responded to comments they received."

Etc.

Here's the ultimate brush off:

"Very few comments were received on principles 4, 5, 6, 7, 8, 9, and 10."

That's it! No more details about comments related to those principles! As if very few comments mean absolutely no problem at all! Very well then. No problem. Let's move on.

Recall that in January I sent in a comment regarding the violation of 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.") See "Tilting Again at the PhRMA Windmill."

Sh*t! Missed the cutoff for this report, which was December 31, 2006!

No matter, even if I did make the cutoff, I am sure my comment also would have been brushed off along with the other "very few comments."

To access the PhRMA reports, click here.

GSK's YouTube Disease Awareness Sponsorship

Recently, I challenged pharmaceutical marketers to embrace Web 2.0 technologies and even to incorporate consumer YouTube-like videos in their direct-to-consumer (DTC) ads (see, for example, "YouPharma(tm): A Brave New World of Marketing?" and "YouPharma: New Rules for Pharma Marketing and Social Media"; BTW, take our online reader survey and get this reprint FREE!).

It now appears that GlaxoSmithkline (GSK) is the first pharmaceutical company to take me up on my challenge, albeit not in the DTC arena but as an unbranded, sponsored, Restless Leg Syndrome (RLS) disease-awareness YouTube video.



You can click on this image to see the video.

Actually, this video ("My Dad has Restless Leg Syndrome"), which has been viewed more than 73,000 times, was uploaded to YouTube in October, 2006. Therefore, I cannot claim credit for influencing GSK.

The sponsored message at the end of the video states that "My dad is one of a Million people in the UK who suffer from RESTLESS LEG SYNDROME."

Is RLS More Prevalent in the US than in the UK?
GSK, on its U.S. ReQuip Web site, claims "RLS affects approximately 1 in 10 adults living in the United States." That's about 22 million US adults over the age of 20. The UK has about 60 million people, about one-fifth of the US population. Therefore, I would have expected -- based on the US 10% RLS rate cited by GSK -- that there would be approximately 4 Million UK adults with RLS. Yet, GSK estimates only 1 Million. What gives? Is RLS more prevalent in the US than in the UK? Or, are the Brits less susceptible to marketing BS (aka, "disease mongering")? See "Disease Mongering and Pharma Credibility."

I'm not sure how much GSK paid for this YouTube video sponsorship, but 73,000 views is not too shabby. One has to wonder, however, who is viewing this video and what impression it is making.

Luckily, Web 2.0 allows us to get some insight into that question by looking at some of the comments the video has received. Most comments were about how cool it was:

CRAZY!..to long for me

cool... you only need a lot of things and a large house ;)

HAHAHA great video :D must've been fun cleaning up afterwards lol

holy.........snap..........how long did that take you to set up?

the toilet roll was cool. awesome job!

But, there were a few comments mentioned RLS:

I never heard of this so excuse my ignorance. How exactly does it make you suffer to have restless legs? I imagine it is worse for a person in the same bed getting kicked all the time.

First, wow. Second, those are some restless legs. Third, the person that made this must have seen the video Japanese Dominos before they made this.

In my random sampling of comments, I did not find any that looked like they were planted by GSK marketers or their agents. I also did not find any product name mentioned in any of the comments.

At the very end of the video is the "money shot" -- a URL where the viewer can go to find more information about RLS: www.legsinfo.com (ie, http://uk.restlesslegs.com/). The site recommends that you talk to your doctor about treatment. That's about as close as you can get to providing treatment information to consumers in the UK. In the US, on the other hand, unbranded sites can link out to the product site.

How to Move This Into DTC Land
The dominoes video is indeed entertaining, much more so than that specially-designed chair in the ReQuip DTC TV commercials seen in the US. Could the video be adapted to DTC? It would have to be edited so that the product can be mentioned along with the benefits and fair balance side effect information.

Perhaps the dominoes can set off product messages at strategic points, not just at the end as in the current YouTube version.

Some dominoes could represent RLS symptoms being "knocked down."

Etc.

I wonder how the FDA would look at such an ad?

Pharma Hires Charlatans for Research & Marketing!

What would you call a doctor who "violated the protocols of every study he led that [the FDA] audited?"

Or a doctor who was criticised by a medical board "for writing narcotics prescriptions for patients he knew were using false names, a violation of federal narcotics laws?"

Or a doctor who "repeatedly prescribed narcotics and other controlled substances to addicts, renewing one patient's prescriptions six weeks after the patient was jailed and telling another that his addictive pills should be thought of as 'Hamburger Helper.'"?

Or a doctor who "prescribed narcotics to pregnant patients, one of whom prematurely delivered a baby who soon died."?

I would say that calling this doctor a CHARLATAN would be justified!

Yet, according to a New York Times story, this doctor, whose name is Dr. Faruk Abuzzahab, has been repeatedly hired by several pharmaceutical companies to do clinical trials and make marketing presentations:

"Takeda, a Japanese drug maker, confirmed that Dr. Abuzzahab was doing a study financed by the company on its sleep medicine, Rozerem. Eisai, another Japanese drug maker, said that although Dr. Abuzzahab had signed a clinical trial agreement with the company to study its Alzheimer’s drug, Aricept, it told him two days after a reporter asked for comment on the case that he was not qualified to be an investigator. And at AstraZeneca, for which Dr. Abuzzahab said he had performed clinical trials and still gave drug marketing lectures, a spokesman said the company was 'concerned' about Dr. Abuzzahab’s disciplinary record."

And Dr. Abuzzahab is not the only charlatan to receive drug company money to do research and marketing:

"The Times's examination of Minnesota's trove of records on drug company payments to doctors found that from 1997 to 2005, at least 103 doctors who had been disciplined or criticized by the state medical board received a total of $1.7 million from drug makers. The median payment over that period was $1,250; the largest was $479,000."

This is only the tip of the iceberg!

Dr. David Rothman, president of the Institute on Medicine as a Profession at Columbia University, said the Times analysis revealed a national problem. "There’s no reason to think Minnesota is unique," Dr. Rothman said.

"Clinical trial investigators must be culled from only the finest physicians in the country,” he said, “since they work on the frontiers of new knowledge. That drug makers are scraping the bottom of the medical barrel is an outrage."

Outrage indeed!

What do drug companies, their trade association, and the FDA have to say?

Drug makers refused to comment, said they relied on doctors to report disciplinary or criminal cases, or said they were considering changing their hiring systems. "We have our own internal processes for dealing with these matters, which are under way," said Jim Minnick, an AstraZeneca spokesman. [Isn't that what they said at the start of the Pink Cupcake Caper?]

[Here's the clincher!] Gene Carbona, who was a Merck regional sales manager with 12 years experience in drug sales, said the only thing the company considered when hiring doctors to give marketing lectures was "the volume or potential volume of prescribing that doctor could do." He also said that had he known that a doctor had a disciplinary record for excessive prescribing, "I would have been more inclined to use them as a speaker."

Karl Uhlendorf, a spokesman for the Pharmaceutical Research and Manufacturers of America, said the trade group would not comment on The Times’s findings.

Asked about the Minnesota analysis, the deputy commissioner and chief medical officer of the Food and Drug Administration, Dr. Janet Woodcock, said the federal government needed to overhaul regulations governing clinical trials and the doctors who oversaw them. [Oh God! Not another FDA system that needs overhauling! Will they ever do their jobs and stop using these stories to make a case for more and more money? Enough already!]

Heaven help us, because when charlatans control the testing of drugs, we are definitely screwed!

Again, I call upon the pharmaceutical industry to reveal the grants it gives to individual physicians to do research and the fees they pay to individual physicians for consulting (see "Dollars for Docs: More Scrutiny Needed"). Name the names.

I hope that other states follow Minnesota's lead in making medical board sanctions against physicians publicly available.

Let's see the entire iceberg before it's too late to adjust the drug industry's course and the entire clinical trial ship sinks!

Weekly Pharma News Review

There's so much news coming out about the pharmaceutical industry that I would love to comment on, but I haven't the time. Here are a few stories that came across my desk this week that fall into that category. By your clicks, I can determine which ones I may dive into deeper in future posts to this blog.

Ketek: Drug's chilling path to market

Aventis Pharmaceuticals Inc. thought it had a blockbuster in Ketek pronounced kee-tek. It would be marketed as the next amoxicillin, a widely used antibiotic to treat the sinusitis and bronchitis that plague millions of Americans each year.

But before Ketek could come to market, the FDA required proof that the expensive new drug was at least as good as the existing treatment. So Aventis devised Study 3014, a clinical drug trial involving 1, 800 private physicians and thousands of their patients nationwide.

But something went awry. You can read more about the story here and view my comments regarding this drug trial that I made back in May, 2006: "Celsius 3014: Ketek, Drug Safety, & Bioterrorism"

Pfizer Charged in Nigeria With Using Children as Test Subjects

Nigerian officials say Pfizer illegally used 200 children, some of whom died, as test subjects without getting parental consent, the Washington Post reported today. Pfizer faces criminal and civil charges that may result in more than $2 billion in fines, The Post said. Pfizer denies it acted inappropriately and said Nigerian government officials were aware of the research program.

I wrote about this and compared it to the movie Constant Gardener back in May, 2006: "Pfizer Imitating Art or Vice Versa?"

States: Beware of Pharma Lobbyists Bearing Gifts

WHEN LOBBYISTS for major drug companies embark on major pushes with politicians, the results are seldom laudable. Though there is reason to hope that a new Merck vaccine, Gardasil, will significantly reduce the incidence of cervical cancer, lawmakers nationwide moved with unseemly haste to require inoculations for all young girls. Their rush seems especially precipitous in light of a new study that has raised questions about how effective the vaccine ultimately will prove.

I'll file that under "I told you so." See my post "Does Merck Need a Vaccine for Bad PR?" and the followup post "Gardasil: Less Hype May Help".

Viagra May Kill Your Sperm

New lab studies suggest the little blue pill may impede fertility, and so the researchers say “recreational users” should be informed the drug may hurt their sperm function.

"Given that the majority of sperm acrosome react on exposure to (Viagra), the drug may cause significant impairment to their fertilizing potential," they write in the Fertility and Sterility journal.

Of course, not every guy may be upset to hear this. For some, it may taken as a green light to have more unprotected sex. And this is where Pfizer turns a liability into a brand new marketing opportunity, right?

Younger fellas, who don't want to have kids, may now think of Viagra as not just a party drug, but a form of birth control. And for those older gents with erectile dysfunction, well, they may now be further emboldened to pursue those elusive May-December relationships, and not have to worry about appearing to be an offspring’s grandfather, instead of...daddy.

That's it for now. It seems I've already commented on most of this, except for the Viagra-disabled sperm. Maybe on Monday...

What is a Marketer's Goal: Legacy or Sales Today!?

I wasn't going to write about IT, but I just can't help myself!

IT happened last week on an episode of the Sopranos.

I'm not talking about Tony maneuvering Robert "Bobby Bacala" Baccalieri, Jr. to "pop his cherry" and kill someone as part of a deal to import counterfeit drugs from Canada into the US. That subplot -- no doubt in my mind -- was paid for by PhRMA, the drug industry's trade association and long-time terrorist scare-monger (see "PhRMA's Terrorist Plot").

So WHAT am I talking about?

Let me try and do this without mentioning any product name (search engine spiders be damned!).

I am talking about a DTC ad appearing within the Sopranos -- an ad for a sleep aid medication that features a historical figure in a stove-pipe hat and a creepy woodlands creature that talks.

According to DTC expert Bob Ehrlich:

"If the [DRUG NAME REDACTED] ad does not deliver positive ROI, then at least it will live forever in Sopranos boxed DVD's and in syndication. That is more of a legacy than most marketers get."

To which I MUST say, whaaaa!?

Holy shit! There it is folks! In black and white: LEGACY, NOT SALES is what up-and-coming pharmaceutical marketers should strive for!

I mean, how else are we to interpret this? Erhlich, at least twice in his DTC Perspectives commentary, side steps the ROI issue:

"I am not sure if [HISTORICAL FIGURE IN STOVE-PIPE HAT] and [CREEPY WOODLANDS CREATURE] have sold enough sleeping pills for [GULLIBLE PHARMA COMPANY, WHICH SEEMS TO BE PROFITING ENOUGH FROM OTHER PRODUCTS TO ENABLE IT TO IGNORE LOSES ON ITS SLEEP AID PRODUCT] to get a good ROI."

"Only [SAID COMPANY] has the actual performance data to decide whether this commercial is successful. The fact that they continue to run it says they believe it is good."

Bull! What do you mean only [DUMB DRUG COMPANY] has the "actual performance data"? The numbers are out there -- and don't take this blogger's word for it. See this post made to The World of DTC Marketing: "Spend $110 million for $76 million in sales?"

How's that for performance?

Erhlich encapsulates what appears to be every pharma marketer's wet dream:

"[DRUG COMPANY THAT NEEDS TO WAKE UP -- YOUR AD AGENCY HAS NO CLOTHES! HELLOOO!] has been criticized for creating this odd commercial. Bloggers have been poking fun at it and pointing out how poorly it has done [UNDERSTATEMENT]. Yet, being selected to be part of a Sopranos episode is a creative honor that most marketers would welcome. I remember feeling proud that my brand, Junior Mints, was featured on Seinfeld when Kramer dropped one in the stomach cavity of a surgery patient. There is something great about being incorporated into pop culture."

Bob, have you made this argument to the shareholders of [DRUG COMPANY THAT IS SATISFIED WITH ABOUT 3% SHARE OF THE SLEEP AID MARKET]?

Who knows? Maybe the last episode of The Sopranos will immortalize Avandia and incorporate IT into pop culture as the instrument of Tony's Soprano's death. Here's the plot line:

Tony finds out he has Type II diabetes and Phil Leotardo, who is pissed off that Tony viciously beat up one of his men for harassing his daughter, recommends a doctor, who unbeknowst to Tony, owes Phil a favor. This doctor prescribes Avandia to treat Tony, who promptly has a massive MI and collapses on top of a stripper in the back room of the Bada Bing [I know ... that MI has been a long time coming, Avandia or no Avandia]. Sil, as he has done many times before with other dead bodies, cuts up Tony's body and makes it disappear at sea off Atlantic City, NJ. For good measure he also has the whole Soprano family whacked and he and his wife gloat in the final scene as they contemplate their new pop culture fame.

To be continued as a new HBO series...The Dantes in Hell!