Friday, June 29, 2007

Google's "Old School" Health Advisory Council

Google recently recruited about a dozen or so healthcare experts to form the Google Health Advisory Council (see Google Blog).

The mission of this council is "to help us better understand the problems consumers and providers face every day and offer feedback on product ideas and development."

Now, I'm not complaining that Google didn't pick me or any other healthcare blogger to be on this council. Others have already pointed out this deficiency:

"Looking at the list, it sounds like a lot of old-school, ivory tower types drafted for their titles. Not a lot of youth nor medical bloggers here, which would have been better choices, considering the demographic of the web." (see Kevin, M.D. post).

I've probably been on Google's sh*t list ever since I posted my "Girl from Google" (GfG) criticism back in November, 2006. So, I really didn't expect to be invited.

However, if anybody from Google read my GfG post -- and I am sure they did -- they should have realized that what they don't know about the pharmaceutical industry -- a major source of their health advertising budget -- could fill a google of pages!

I say this because Google allows or used to allow adwords that violate FDA regulations (see Lunesta, Google, and "bAdWords") and their attitude is "We don't think it's a problem and it's not our roll to enforce the law." Thus, whenever I see Google folks at pharma industry conferences, I cringe. They just treat drug ads as if they were ads for any other product, like laundry detergent.

The Google advisory council does include David Kessler, M.D., Former FDA Commissioner and, I suppose, he could advise Google about FDA regulations -- if this were 1990 before Google was even a twinkle in Sergey Brin's eye!

There are so many loopholes in FDA regulations regarding online direct-to-consumer pharma marketing you could drive a truck through them. No, wait! There are NO FDA regulations specifically related to the Internet or the Web 2.0 (see "Where's DDMAC's Head At?").

Undoubtedly, Google gets the vast majority of its health ad revenue from the pharmaceutical industry. Just on the basis of that fact, it needs at least one pharma marketing/advertising expert among its advisors.

Google Should Lead New-School Thinking, Not Follow Old-School Advice!

More than that, Google and other online organizations wishing to present responsible drug ads and other pharmaceutical industry communications to consumers need to include experts in pharma eMarketing, especially those experts who want and know how to do it right.

I would include, for example, Fabio Gratton, Co-founder and Chief Innovation Officer, Ignite Health, on the list.

Working with experts like Gratton, Google could take a leading position in the development of guidelines regarding pharma's participation in social media, and what is acceptable and what is not.

Old-timey FDA commish's just won't cut it and don't expect much from the current FDA leadership either!

That's my opinion, and I'm sticking to it!

Thursday, June 28, 2007

Pimp My Doc!

Catherine DeAngelis, the editor of JAMA, is costing her "ride" (aka the ad folks at JAMA) a bundle of pharma ad dollars because she once said to a doctor who dodged a tough question during an industry-funded speech, "Do you understand what prostituting yourself is? That's what you just did." This is according to a recent post to the Wall Street Journal's Health Blog (see "How to Rile Up the Editor of JAMA").

This got my creative juices following and I just had to interpret Catherine's remarks visually. Maybe she''ll frame the above image and hang it on her office wall. (BTW, don't write me any comments about the political correctness of this image. I work with what I have.)

According the WSJ Health Blog:
How does DeAngelis reconcile her tough stance on drug information with the pharmaceutical ads that fill JAMA? She notes that ads don't run in the section of the journal where research studies appear, and says she routinely bars ads that she deems misleading: "A couple weeks ago, the ad people came down and said, 'You know, you've cost us $750,000 this year because you've turned down ads.' I said, 'Is that all?'"
This leads me to ask, How much money does JAMA and other medical journals make from pharma advertising if Catherine can shrug off $750,000 per offhand remark? At what point does it become Kettle, Pot, calling each other black? (Don't write me about the PCness of that either!)

Tuesday, June 26, 2007

PhRMA Intern Proves "No Strings Attached" to Pharma-Sponsored CME!

Yes! It's PhRMA Intern!

In the last episode of PhRMA Intern, the intrepid Washington, DC visitor from an Ivy League school, disguised as mild-manner Emily Jameson, summer intern at Pharmaceutical Research and Manufacturers of America, helped the industry get a sneak preview of the movie SiCKO (see "PhRMA Intern Makes Movie Mogul an Offer He Can't Refuse!").

In that episode, PhRMA Intern exhibited her dark side and fans wondered if she would continue to employ those powers over all others in her never ending battle for believability, justice for pharmaceutical companies, and the PhRMA way. Or would she develop new and more subtle means of persuasion?

The answer may be found in this episode:

PhRMA Intern and the No-Strings-Attached CME Proof!

Emily, as she has been instructed to do by her boss Ken Johnson, PhRMA SVP, scans the morning papers every morning.

While reading her copy of the New York Times recently, Emily noticed an op-ed piece by Daniel Carlat, a professor at Tufts Medical School and editor in chief of The Carlat Psychiatry Report. The piece was entitled "Diagnosis: Conflict of Interest."

Emily remembered that Ken told her during orientation that PhRMA's Code on Interactions with Health Care Professionals assures that there are "no strings attached" to pharmaceutical company sponsored CME.

What Emily did not realize, however, was that Ken was already preparing a devasting "letter to the editor" of the NY Times in response to Dr. Carlat's OpEd piece. Here's Ken's letter:
"Daniel Carlat is simply wrong when he questions the educational value of continuing medical education programs supported by America’s pharmaceutical research companies.

"Our voluntary marketing code for members states explicitly that when pharmaceutical research companies provide financial support for medical conferences, control over selection of content, faculty, educational methods, materials and venue belongs to accredited conference organizers and not the companies.

"The Code on Interactions with Health Care Professionals helps to ensure that pharmaceutical companies can help health care providers receive valuable information about available medicines — with no strings attached. And there is no reason to believe that independent program organizers are jeopardizing their reputations or compromising their medical judgments because pharmaceutical companies have provided financing for continuing medical
education seminars." (See "New York Times Publishes Letters in Response to My Op-ed" over at The Carlat Psychiatry Blog.)

Emily had a different idea for proving the "no strings attached" argument.


PhRMA Intern! Who can change the course of mighty news stories, bend the truth at will, and who disguised as Emily Jameson (no relation to Jenna Jameson), mild-mannered intern for a great pharmaceutical trade association, fights a never ending battle for ... yadda, yadda, yadda.



Friday, June 22, 2007

Can an In-home Electronic Pillbox Solve Our Medication Error Problem?

Do seniors really need a $200 per month machine that looks like a bread maker -- and which is somewhat bigger than a bread box -- to dispense pills?

Will an in-home electronic pillbox solve this country's medication error problem?

Maybe the only two entities that think so are the company that invented the machine and the FDA.

"The device can be programmed to dispense individual doses of up to a month's worth of 10 different drugs, according to its manufacturer, INRange Systems Inc. The Web-connected medication box allows pharmacists, doctors and nurses to tweak both the dosing schedules and dosages of drugs loaded into the device in special blister cards. The company-described 'electronic nurse' alerts patients when it's time to take a drug with visual and audible alerts.

"The bread-box-sized device may reduce drug identification and dosing errors, the FDA said. Expected users include aging and forgetful patients, as well as those with HIV who must adhere to complex treatment regimens." (See: "Computerized Pillbox Is Cleared").

Here are some problems I foresee that will limit the adoption of this contraption:

  • The company and the FDA claim that the device will help prevent medication errors that "harm at least 1.5 million people in the United States annually." While INRange claims that "the greatest rise in prescription medication errors occurred in the ambulatory setting," the vast majority of medication errors still occur IN HOSPITALS, not in homes. Also, if physicians prescribe the wrong medication in the first place, this device will continue to dispense the wrong medication unless someone tells it differently.
  • The device dispenses pills in blister packs, which many seniors have trouble opening! Not only that, but pharmacists have to load the pills in these packs instead of simply putting them in bottles. I'm sure that's more work for the pharmacist.
  • The cost! Did I mention the cost? Not only the $200 per month per patient, but to Medicare if it had to pay for millions of these devices. Do the math.
  • Doctors and pharmacists are expected to remotely monitor and manage the devices to alter dosing and make sure the patient is compliant. Sure, that'll happen!
  • Imagine a HAL computer scenario if you will. Or just plain hackers. Or software bugs. Or power outages! Imagine the havoc these electronic bogey men would cause. Oh, the humanity!
  • Did I mention the cost?
I don't know why I bother writing about this, except that it illustrates an example of warped FDA priorities and BS marketing by INRange. If we really want to solve the medication error problem in this country, we need to computerize prescribing and dispensing at doctors' offices and in hospitals, not in the home!

And the drug industry -- including the FDA -- must do more to address the problem through patient/physician education and promotion of ePrescribing at least, instead of worrying so much about counterfeit drugs, which kill far fewer Americans than medication errors!

That's my opinion, and I'm sticking to it!

Thursday, June 21, 2007

The Drug Industry Needs Constructive Criticism, Not Pugilistic Put Downs

Every once in a while I like to survey readers of Pharma Marketing Blog to learn more about who you are and what topics you are interested in. You might have seen the survey pop up when you came here today.

If you have a minute, please fill out the survey and help me make this blog more useful to you. If you haven't seen the pop-up, you can take the survey by clicking here.

What I Have Learned
Preliminary results of the survey lead me to believe that this blog is addressing an umet need among pharmaceutical company insiders. Here's a summary of the reults so far:
Professional Affiliation of Readers
  • 41% are employed in a pharmaceutical, biotech, or drug device company
  • 11% are employed in a marketing communications company or advertising agency
  • 14% are employed in another type of company that services the pharmaceutical industry
Support for the Pharmaceutical Industry
  • 66% are somewhat or very supportive of the pharmaceutical industry in general
  • 19% are somewhat or very critical of the pharmaceutical industry in general
Some Topics of Interest to Readers
  • 55% chose "new ideas for drug marketing"
  • 49% chose "questionable marketing practices"
  • 43% chose "physician marketing"
  • 43% chose "FDA and regulatory/legal issues"
It's interesting that although almost 60% of blog readers feel that Pharma Marketing Blog is somewhat or very critical of the industry (see Pharma Blogosphere Survey Summary), two-thirds of our readers are themselves on the "other side of the fence"; ie, somewhat or very supportive of the industry! And 40% are employed within the industry.

Constructive Criticism Lacking in Trade Press
I interpret this to mean that industry insiders and supporters want to learn from constructive criticism, which I hope is what I am providing.

Constructive criticism may be a great unmet need that most of the mainstream trade publications like Pharmaceutical Executive Magazine, MM&M, DTC Perspectives are NOT satisfying.

These great publications are highly esteemed by industry insiders and often read cover to cover. They have great reach within the industry and among the very top leadership of big pharma companies. It's a shame they tend to repeat conventional wisdom and stick to the industry's PR playbook.

Recently, I had a chance to speak with Anne Devereux, CEO, LyonHeart and TBWA\WorldHealth, in a Pharma Marketing Talk Podcast. The topic was: "Questioning Conventional Pharma Marketing Wisdom. How Disruption Can Lead to Game-changing Ideas." The disruptive technique her agency employs includes bringing ideas from "outsiders" into the mix to "challenge conventions in an environment that has become less about risk taking and too often about risk management." (Listen to the interview here.)

My Proposal to PE, MM&M, et al
If ad agencies can bring in ideas from "outsiders," then I think PE, MM&M, et al can do the same.

I propose that these great publications consider providing a few "column inches" of space to commentary from constructively critical bloggers like myself. You can call it "A Contrarian POV" and disclaim responsibility for the comments so that your advertisers won't be pissed off!

I would be glad to contribute to such a column.

Wednesday, June 20, 2007

Rozerem DTC Ads: New Paradigm or Paradox?

I love Pharmaceutical Executive Magazine! I especially like it when they quote me as they did in this month's (June 2007) issue. You'll find me quoted in the article "A Dream Campaign: Takeda's Rozerem ads aren't just fun. They're a new paradigm for insomnia treatment." The article was written by George Koroneos, Associate Editor at Pharmaceutical Executive.

I'm sure many of you have seen the article and read my quotes there. No doubt you also said something like "Wow! This guy knows his stuff!" or "He calls it like he sees it!" or "I wish I could have said that!"

I'll get to my quotes later, but, first, let's analyze the article's title, which makes two claims:
  1. The ads are fun, and
  2. The ads are a new paradigm
OK. I admit the ads ARE fun. I certainly had fun mocking them over the past year (see, for example, "Rozerem Ads Dis Lincoln, Show Beaver"). But I'm not one of those guys like Mel Sokotch who the article quotes as saying "Abe and a muskrat are not in line with what this industry is about."

News flash! It's not a muskrat, it's a beaver! You can tell the difference by looking at the tail: "Although [muskrats] resemble beavers, they are much smaller and lack beavers' distinctive flat leathery tails, having instead thinner tails." (Wikipedia!)

Drugs ARE serious and funny ads may not be appropriate for some drugs. I cannot imagine, for exampe, a funny ad for Gardasil. But for insomnia -- which is a condition that has long been the butt of jokes -- I think it's OK to have funny or fun ads.

But more important than whether the ads are fun or not is whether they are effective, which brings us to the "new paradigm" claim.

New paradigm for what? The subtitle says "paradigm for insomnia treatment." In other words, the ads are a new paradigm (ie, model) for making viewers fall asleep!

Editorial faux pas, yes, but now I finally get what Takeda is trying to do with its direct-to-consumer (DTC) Rozerem ad campaign: make us fall asleep, which is something Rozerem itself may not do too well, if you look at the sales data presented in the article.

The article quotes these sales figures from IMS Health:
"For the first quarter of 2007, [Rozerem] has earned $28.1 million, outpacing Sonata in the total sleep aid category, but far below what Lunesta ($181 million) or Ambien ($653 million) brought in during the same time period."
Let's assume Sonata's sales were $25 millon for the period. If we add up all the sales for all 4 drugs and plot the percentage of each drug's sales in a pie chart, here's what we get:

In other words, sales of Rozerem account for only 3% of the total sales racked up by these 4 drugs in Q1 2007! Keep in mind that this does not represent the complete market for sleep aid medications. If other drugs used to treat insomnia were included, Rozerem's share would be much less than 3%. Whatever the actual number -- which MUST be less than 3% no matter what! -- this is a dismal showing for a TOP-ten DTC spender!
Yes, Rozerem is #10 ($118 million) on the 2006 list of DTC spends for Rx products. Lunesta and Ambien CR are #1 and #2, respectively ($329 million and $207 million). During the first quarter of 2007, Takeda spent at an even higher rate: more than $40 million (see "Rozerem Ad Spending Exceeds Sales!").
The Slow Build Defense
The PharmExec article quotes me as saying "While the company is doing a slow buildup, the sales are doing a slow burn." I still stand by that even though Chris Benecchi -- product director for Rozerem marketing -- "claims that the slow build was the plan all along."

Puh-leez! You claim that market share is low because Takeda was a good little pharma company and held off running its DTC campaign for 1-year after launch. Given that, how does a "slow build" make any sense?

As I was quoted in the article, "I've never heard of such a thing in pharmaceutical marketing."

It's a Horse Race, NumNuts!
Consider this analogy: You're a horse. You're in a race. You have trouble at the gate and get off to a slow start. Your jockey holds you back, sticking to the original plan for a "slow build." It's only a quarter-mile race! You don't have time for the slow build! But your jockey is in charge. You lose the race!

  • Horse = Rozerem
  • Race = Recuperation of investment and profits before patent expiry
  • Jockey = Guess who!
Jockeys can make mistakes, but what galls me are all the articles written in trade publications and the press (e.g., "Am I Dreaming, or Is This a Rozerem Ad?") touting how great the Rozerem campaign is and all the accolades heaped upon the agencies involved (see "Takeda - Fire These Guys!"). No one with any pharma industry publishing authority is admitting that the emperor has no clothes. Why is that?
Who Pays the Piper?
I notice that the issue of Pharmaceutical Executive Magazine in which the Rozerem article appears includes a supplement entitled "Agency Confidential." Guess which agency spent a fortune to place a 2-page ad spanning the inside cover and first page of that supplement? Yep. AbelsonTaylor (AT), the main agency responsible for Abe and the Beav and the "slow build."

I suspect that publications that claim to offer useful advice to pharmaceutical executives must tread carefully lest they lose big agency advertisers. They certainly cannot come right out and say that AT or Takeda has no clothes! Not directly. At least Pharmaceutical Executive included sales figures in its article if anyone cared to look at them like I did.
Meanwhile, Rozerem is the laughing stock of pharmaceutical marketers, some of whom, Koroneos said, "liberally made snide (but mostly off-the-record) comments about the campaign" at a recent DTC Perspectives conference in Washington, DC.

Perhaps this is just a case of "beaver envy" as Koroneos quips, but I don't think so! All you have to do is look at the numbers. They're right there in the article!

Tuesday, June 19, 2007

From Vioxx to Avandia: Whistleblowers and Dangerous Drugs

I received this note that I am passing on:

THE GOVERNMENT ACCOUNTABILITY PROJECT (GAP) invites you to join us for "From Vioxx to Avandia: Whistleblowers and Dangerous Drugs" - a Live Telephone Conference Call with Q & A on Thursday, June 21st, at 6:00pm - 7:00pm eastern.

The call will feature David Ross, Ketek FDA whistleblower and Mark Cohen, GAP Food & Drug Safety Director.

To take part: email To receive the call-in info by text message, please include the number in your email.

GAP has been involved in a number of prominent cases related to restricting the presence of dangerous drugs on the market, most notably Vioxx. The Vioxx scandal came to light when Dr David Graham, a top FDA scientist and GAP client, testified before a Congressional committee that Vioxx had likely caused as many American fatalities (heart attacks and strokes) as had the Vietnam war. Moreover, as it was structured, FDA could not be relied upon to protect the American public from future drug disasters.

Join us for a live conference call with David Ross, the former FDA medical officer who blew the whistle on the mishandling of the approval process for the antibiotic Ketek, and Mark Cohen, GAP food and drug safety director.

The revelations that Dr. Ross and others made resulted in significant restrictions in the approved uses for Ketek.

The recent controversy over the diabetes drug Avandia seems to confirm Dr Graham’s critique of the agency’s culture and processes. Reforms being discussed by Congress right now could go some way toward changing the way the agency balances the interests of rapidly bringing new drugs to market and the interests of ensuring that news drugs are truly safe and effective.
Join us on this live conference call to get the latest update on the progress of these reforms and to put questions directly to David Ross and Mark Cohen regarding our work on Drug Safety and the experience of being a whistleblower within the FDA

For call-in details, email

Monday, June 18, 2007

It Was Politics That Killed Avandia, Says Glaxo

Remember the ending of the movie King Kong? A policeman said "Well, the planes got him!" but Carl Denham said "Oh no, it wasn't the airplanes. It was beauty killed the beast."

Of course, the press picked up on that right away because it made for a much more interesting story. It had, as they say, more human interest.

Now, instead of a beast we have Avandia, a blockbuster reeling to and fro atop the diabetes marketing tower ready to take a nose dive to the ground -- in fact it may already be on the way down.

"The total number of Avandia prescriptions written by physicians has fallen by 20% since safety concerns about the drug surfaced last month," said Chris Viehbacher, president of London-based Glaxo's pharmaceuticals business in the U.S. "The number of Avandia prescriptions doctors are writing for new patients has fallen by 40% over that same period." (See "Glaxo Says Avandia Is Victim of Politics").
Glaxo -- Avandia's marketer and guardian angel -- is shifting the blame for Avandia's woes away from impersonal science (the planes) and towards the human element; ie, those bad Democrats in Congress.

"It's pretty much Democrats beating up on us," says Viehbacher.

Even though Glaxo is invoking the Waxman et al bogey man, Viehbacher still claims that "In the end science will win."

Meanwhile, neither Glaxo nor the FDA is rushing to show any more "science" to support claims that "Avandia is as safe for the heart as other diabetes drugs."

Friday, June 15, 2007

Rozerem Ad Spending Exceeds Sales!

I pointed out several months ago that Takeda is spending more money on its quirky Rozerem direct to consumer (DTC) ad campaign than it is making in sales of the beleaguered sleep aid product (see "Rozerem DTC Emperor (Still) Has No Clothes" and previous posts found referenced there).

While some DTC experts questioned whether this was true (see "What is a Marketer's Goal: Legacy or Sales Today!?"), I now have independent verification that Rozerem DTC return on investment is definitely in NEGATIVE territory!

As reported today in the Chicago Tribune ("Takeda dreams of waking slumbering pill's sales"):
"In the first quarter of this year Takeda spent more than $40 million on Rozerem ads, TNS Media Intelligence figures show, and the company reported $26 million in sales during the same period."
ROI = ($0.35)

I think that's right.

If not, here's another way to put it: for every dollar Takeda is spending on its Rozerem DTC campaign, it is only making $0.65 in sales!

How long can this lunacy continue? You tell me!

BTW, here's Takeda's defense:
"We are patient and we know it takes time," said Andy Hull, senior vice president of marketing at Takeda. "We think it is important to educate patients about a safer insomnia product."
Education, smeducation! Andy, baby, you're drinking your own Kool-Aid! DTC educates? -- NOT!

Does anyone agree with me that this guy should be fired?!

Pharma Marketing Blog is #11... Oops #20... in List of TOP 100 Healthcare Blogs!

The Healthcare 100 is a global ranking of the top English-language healthcare blogs. The list is a creation of Cary Byrd, author of eDrugSearch Blog.

The stated goal of The Healthcare 100 "is to provide both bloggers and blog readers interested in all aspects of healthcare with a simple way to find the most influential blogs. We rank each blog’s influence based on a multimetric algorithm."

I am proud that Pharma Marketing Blog achieved a rank of #11 on this list. My goal: Make the TOP 10 list!
P.S. After Cary added more blogs to the list, Pharma Marketing Blog dropped to #20 in the list. All other blogs also dropped; In the Pipeline dropped to #16 for example. Still, #20 isn't bad!
The only other pharmaceutical-industry specific blog that ranked higher on the list than Pharma Marketing Blog is In the Pipeline, which was #4 on the list. In the Pipeline was also the top-rated blog in the recent First Ever Pharma BlogosphereTM Ready Survey (download the summary here).

Free CME Without Direct Pharma Support: Is It Possible?

Yesterday, in a post about about pharmaceutical company support of continuing medical education (see "Welcome to the CME Laundromat"), I made a suggestion that, like the rest of us mortals, physicians should pay for their own professional education credits.

This straightforward "solution" to the problem of pharma influence over CME received some attention from other bloggers and their physician audience.

Medical Weblog (Kevin, MD), for example, suggested that "Realistically, if physicians had to pay to attend their own CME lectures, no one would go."

This elicited several comments with different points of view, including the following:
"Realistically, if physicians had to pay to attend their own CME lectures, no one would go."

Speaks for itself, doesn't it?

Wow . . . just wow . . . what a sterling "profession" medicine has become.

Actually, I do pay for my CME, all of it. It just makes me really picky about where I go and what I pay for.

I think if I go to every Grand Rounds at my hospital for a year (which is free) then I can satisfy my CME for the year.

So that is my plan.

Of course, Big Pharma probably pays for half of those speakers, so what can you do.

Demand that hospital officials ban big Pharma from any freebies in the halls of your facility, that's what you can do. Big Pharma's influence over physicians is equivalent to lobbyists' influence over elected officials.

My father was in politics and told me "politicians are like women who walk the streets and do favors for money."

I swore off all "free" CME 4 years ago and only use CME that I pay for, on the grounds that he who pays the fiddler calls the tune and any "free" stuff in the end is nothing but progaganda. I must be some kind of freak because I payed for about 70 hours of category 1 last year. Mostly though puchased audio programs which is much cheaper than traveling to a meeting so I am still ahead.

If we are not adult enough to take responsibility for our own professional development-and to pay for our own pads and pens--then we have no right to expect autonomy as an independent profession.
These responses belie the contention that if docs had to pay for CME, none would go.

BTW, there are several options for delivering CME -- including via the Internet -- which do not require that physicians "go" anywhere except to their home computers or local medical school or hospital. If they attend their professional organization's meetings, they can get CME while there. All these options involve little out-of-pocket travel expense specifically for CME.
Note that ACCME guidelines for commercial support of CME states that "CME providers may not use commercial support to pay for travel, lodging, honoraria, or personal expenses for non-teacher or nonauthor participants of a CME activity."
Whatever the solution, pharma has to get out of paying directly for CME content, even if such support is regulated and at arms length (ie, out of the hands of sales and marketing departments).

Free CME Without Direct Pharma Support
Pharma can still support CME through advertising and exhibits at events that host CME. Right now, only about 11% of CME expenses are paid for through advertising and exhibits (see chart). That may be because most of pharma's CME budget is allocated to creating the content, not advertising and exhibits. If the first option were not available, I am sure the second option would receive much more attention and dollars.

Aside from live CME events, pharma advertising can help support free CME through other delivery channels such as TV and the Internet.

Free CME TV?
Why not have free CME TV for physicians just like we have free soap opera and reality TV for the masses? I note that four of the world's biggest pharmaceutical companies are proposing to launch a television station in Europe to tell the public about their drugs (see "Pharma Shopping Channel?"). If they can do that, they can also do CME TV.

Why not an all-CME TV network? Like the Weather Channel?

Of course, I am only half serious about this, but it is worth thinking about to overcome the challenges.

One challenge is to deliver the CME and doctor ads ONLY to physicians, otherwise all the advertising would have to follow direct-to-consumer (DTC) regulations set by the FDA. As we all know, such advertising is not very educational. Doctor ads need to be more like detail aids than 60-second DTC ads.

Therefore, to do free CME on TV, you would need some kind of closed-circuit channel, an idea that was tried before and failed, which is not to say that it cannot be tried again.

But delivery of video via the Internet is now possible and quite popular. And the Internet offers all the necessary security and verification to assure that only qualified physicians will have access.

Whatever the delivery channel, keep in mind thatdvertising can corrupt editorial content as well (eg, advertisers can pull the $ from online CME events they don't like). That's another challenge Free CME would have to overcome.

Anyway, just some food for thought, which I hope generates some comments.

Thursday, June 14, 2007

Welcome to the CME Laundromat!

In a New York Times Op-Ed piece, Daniel Carlat, a professor at Tufts Medical School and editor in chief of The Carlat Psychiatry Report, characterizes pharma-sponsored Continuing Medical education (CME) as "a new twist on that well-known instrument of corruption, money laundering."
"[CME] content," says Carlat, "is rarely developed by the identified experts. Instead, it is developed by the undisclosed communication company, which is paid by the sponsoring pharmaceutical company." (see "Diagnosis: Conflict of Interest")
Them's fighting words says Robert Goldberg in a post to Drug Wonks:
"Daniel Carlat has a near hysterical piece about that equates pharmaceutical and biotech funding of CME to money laundering. Which I guess makes all the academics, researchers and clinicians who particpate...criminals? Carlat needs to take a dose of the trazadone he defends in one of his newletters that are available for a hefty fee. Which leads me to another point: nothing is stopping self-righteous types like Carlat from going into business themselves to offer CME programs. Oh, and if I were Carlat, I would drop the characterization 'Unbiased' from the description of his expensive newsletter. He is as biased as anyone. Anyone who calls his colleagues money launderers is biased." (This is the entire post)
Nothing like the "you-know-what" calling the other "you-know-what", "you-know-what"! Recall that Drug Wonks are also PR Wonks (also see "Welcome to the PR Machine").

Some more from Carlat:
Drug companies should never have been allowed to become the primary educator for America’s doctors. The Accreditation Council for Continuing Medical Education, a nonprofit organization composed of the major medical associations, establishes the rules that govern continuing medical education. According to the guidelines, companies are forbidden from directly paying doctors who teach continuing medical education courses.

But the standards have a loophole that allows drug companies to circumvent the regulations. They hire for-profit "medical education communication companies" to organize the courses. These companies receive millions of dollars from drug companies to create course work and to pay doctors to deliver the content. Sometimes, they pay doctors to give lectures to other doctors. Other times, prominent doctors are paid to be listed as the authors of journal articles that are written by ghost writers, a practice that was extensively documented in court records from a lawsuit against Pfizer.
Here's the data from ACCME showing the percent of CME income derived from pharmaceutical companies. If you include income from advertising and exhibits at CME events, pharma is responsible for 60% of all CME income (source: ACCME annual report data).

Carlat's Solution?
"The solution could hardly be simpler," says Carlat: "any continuing medical education that is paid for by the drug industry should not be accredited. Drug companies could still pay for any educational event, article or pamphlet they choose, but their courses and materials would no longer bear the imprimatur and implied credibility of accreditation."

Another Solution
How about THIS solution, which is even simpler. Doctors should pay for their own education JUST LIKE THE REST OF US! And, while they're at at, they should pay for their own damn pens and pizza!!!

Wednesday, June 13, 2007

FDA: Zimulti Non-Acomplia!

As reported in the Wall Street Journal Health Blog, an FDA advisory panel unanimously rejected Zimulti:
By a unanimous vote, a panel of experts convened by the FDA just rejected Sanofi-Aventis's weight-loss drug, known in Europe as Acomplia, Dow Jones reports.

The drug has been associated with psychiatric side effects including depression and an increased risk of suicidal thoughts. In a presentation to the panel today, Sanofi officials argued that patients at risk of psychiatric problems could be screened to not receive the drug. The drug has been approved for sale in Europe, but has not been approved here due to concerns over its side effects.
Of course, the FDA could approve the drug application anyway since these advisory board decisions are non-binding. Although I don't think this is likely, keep in mind that the FDA considers the drug safety measures pending in the House of Representatives as a "burden," for regulators (see "FDA objects to parts of House drug safety plan").

Pharma Online Marketing: Got Game?

My friend Fabio Gratton, Co-founder of Ignite Health and fellow blogger at IgniteBLOG: The Perfect Storm, recently wrote about a game on WebMD called "Give Your Legs a Rest." He confessed that the game was addictive.

This game was developed for WebMD’s client, Mirapex, a drug intended to treat Restless Leg Syndrome (RLS) as well as Parkinson’s disease. Mirapex is produced by Boehringer Ingelheim Pharmaceuticals, Inc.

See the screen shot below.

Once I got the idea, I too became addictive to this game.

The object of the game is to score points by aligning three of the same objects (stapler, coffee cup, etc.) horizontally or vertically. You do this by clicking on two adjacent office items, which switches their locations on the board. Try it here and you will soon get the idea too.

While the game is addictive and held my attention for a few minutes, I completely ignored all the surrounding Mirapex promotional advertising and almost did not notice the option to take the quiz to see if I had RLS. [Sample question: I often find myself tired and dragging during the day. Please answer "Yes" or "No". It turns out that this is a trick question: "being tired and dragging" may be symptoms of old age or dissatisfaction with your routine office chores, but they apparently are NOT symptoms of RLS!]

I only played "Level 1: Busy Day at Work", the theme of which was "Conference calls, deadlines, e-mails..." [all of which I ignored while playing the game] "...Getting away from your desk can seem impossible."

I presume one of the goals of Level 1 is to help you cope with RLS by offering tips along the way like "stretch your legs" (see "Quick tips" at the top). If so, I would say this online game, which ties you down to your chair more effectively than usual office activities, runs counter to the message it is trying to convey.

The disclaimer states:
"This tool does not provide medical advice. It is intended for informational purposes only and does not address individual circumstances. It is not a substitute for professional medical advice, diagnosis or treatment. Never ignore professional medical advice in seeking treatment because of something you have read on the WebMD Site. If you think you may have a medical emergency, immediately call your doctor or dial 911."
Putting aside the unlikely scenario of an RLS "medical emergency," I find that this game, in and of itself, offers very little "information" about RLS.

This WebMD offering is called "Advergaming" and is actually a form of online advertising tracked by eMarketer, a market research company. Last month it produced a report called "You've played the game. Now eat the food," in which senior analyst Lisa E. Smith states:
"Like advertisers in other industries," said Ms. Phillips, "CPG [Consumer Package Goods] companies spend far more on interactive marketing campaigns, such as microsites, advergames and downloadable music, than on Internet advertising such as display ads, search and e-mail. This year, CPG companies will spend $600 million to advertise online, just 3.1% of the total $19.5 billion expected."
eMarketer expects US spending on advergaming will hit $344 million in 2011 (see chart).

Is what's good for CPG also good for pharmaceuticals?

I don't think so! The purchasing decision for soda or chips is not that complicated, certainly not as complicated as the decision to ask your doctor whether or not Mirapex or Requip is the best treatment for your RLS symptoms. Therefore, CPG advertisers are really brand advertisers and use online entertainment to keep the brand images in front of you.

Drugs also want to be brands, but they cannot be brands like Coke or Pepsi. If you tie too many positive benefit emotions and not enough risk emotions to a drug brand, you will violate FDA regulations regarding DTC. Pepsi and Coke have no such problem. They can link their brands exclusively to positive images (think happy young partygoers on the beach). They don't have to balance these with negative images of obese youngsters downing 20 ounces of Pepsi in a single gulp!

Drug advertising is held to a higher standard and DTC Advergaming should also be held to a higher standard. There should be a better way to integrate product information into the game itself.

Here's an example.

Remember the TV or card game called "A Game of Concentration?" Here's an online example.

The object is to click on two squares to reveal 2 identical images. If you do, those squares are "turned over" to reveal something underneath. In the TV game, a rebus puzzle was underneath the squares. To win the game you had to solve the rebus.

Can you solve this rebus?

This rebus does not necessarily reflect conventional wisdom. It is intended for gag purposes only and does not address any personal opinions of the Mirapex "give Your Legs a Rest" advergame. It is not a substitute for professional promotion, DTC advertising or "advergaming." Never ignore professional medical communications advice in seeking market share because of something you have read on this blog. If you think you may have an online promotion emergency, immediately call 215-504-4164 or 888-285-5744(8).

Tuesday, June 12, 2007

Alli Newspeak: Oily Spotting is "Treatment Effect"

George Orwell coined the phrase "newspeak" in his 1948 novel Nineteen Eighty-Four (1984). In the novel, it is described as being "the only language in the world whose vocabulary gets smaller every year." An example of Orwellian newspeak is the elimination of the word 'bad' and replacing it with "ungood." That sort of thing. Eventually, by eliminating enough words you can make anything sound less "ungood" as exemplified by the slogan "War is Peace."

Now another well-known British entity -- GlaxoSmithKline (GSK) -- has applied newspeak principles to direct-to-consumer (DTC) advertising. It's latest promotional video for the over-the-counter diet pill ("treatment") Alli blatantly replaces all the nasty-sounding Alli side effect terminology -- including "Oily Spotting," "Flatus with Discharge," "Fecal Urgency," "Oily Evacuation," and "Fecal Incontinence" (see table of side effects here) -- with the single, much less provocative term "Treatment Effect." See the video below.

This, I contend, is a new high (or low, depending upon your perspective) in pharma marketing BS. Recall, that the essence of bullshit is "indifference to the facts" (see "Is Big Pharma Shifty?").

This particular video ad, however, goes beyond mere words and also utilizes a form of "visual newspeak" to calm consumers' fears of "treatment effects." I refer to the image halfway through this video showing a man dressed all in white (see image at left).

This is an interesting image to use as a representation of a satisfied Alli user.

The educational material to be supplied with Alli when it hits pharmacy shelves in the US next week recommends that you wear dark clothing until you are able to overcome the oily spotting, err, I mean "treatment effects."

FDA Approved OTC But Not DTC!
The video also makes a big deal of the fact that Alli is the "only FDA-approved over the counter weight loss product." What the video DOESN'T tell you, however, is that the FDA does NOT approve ads for OTC products like Alli. If it did, perhaps this little newspeak Alli ad would get at least a slap on the wrist from the FDA (ie, a "warning letter").

The Federal Trade Commission (FTC) DOES regulate OTC advertising. But the FTC doesn't care whether side effects are adequately communicated as does the FDA. The FTC is only interested in whether or not any false claims are being made. If the ad said, for example, that on average people lose 30 pounds in the first year with Alli (as opposed to the actual 15 pounds), then the FTC might slap GSK with a fine (something that the FDA cannot do, by the way).

Unfortunately, FTC has no jurisdiction over newspeak and the Alli ads are "honky dory" -- or should I say, not ungood -- as far as they are concerned.

Hat Tip to PharmaGossip for the video.

Monday, June 11, 2007

PhRMA Intern Makes Movie Mogul an Offer He Can't Refuse!

Yes, it's PhRMA Intern! Strange visitor from an Ivy League school who came to PhRMA with powers and ability far beyond those of Ken Johnson.

PhRMA Intern! Who can change the course of mighty news stories, bend the truth at will, and who disguised as Emily Jameson (no relation to Jenna Jameson), mild-mannered intern for a great pharmaceutical trade association, fights a never ending battle for believability, justice for pharmaceutical companies, and the PhRMA way!

On a Blog, Far, Far Away
Our story begins last week, when blogger John Mack reported that Michael Moore accused PhRMA of sending a "spy" to the Cannes debut of his documentary SiCKO (see "PhRMA Sent SiCKO Spy to Cannes").

That same day, another blogger -- Ed Silverman at Pharmalot -- received a mysterious phone call from Ken Johnson, executive vice president of PhRMA, who explained what really happened:
"This is a pretty desperate attempt to drum up some publicity," said Johnson. "Billy [Tauzin, CEO of PhRMA] had nothing to do with this. I spent 15 years in Washington, and made a lot of friends from Hollywood. And one of them, who I'm not going to drag into this [let's call him Mr. X], called to tell me about it. And I got some pretty good blow-by-blow. But we didn't have a spy there, and we didn't send anyone there. It was a friend from the motion picture business." (see "PhRMA: We Didn’t Send A Spy To Cannes!")
What Ken failed to mention, however, is the role PhRMA Intern played behind the scenes "negotiating" the deal with Mr. X. We can now tell the complete story ...

How PhRMA Intern Made a Movie Mogul an Offer He Could Not Refuse!



...PhRMA Intern!




Thus ends the latest episode of the Adventures of PhRMA Intern!

Will the identity of the MYSTERIOUS MR. X, powerful Hollywood movie mogul, ever be revealed? Will PhRMA Intern be called to testify before Congress and reveal his identity? Or will PhRMA Intern quietly fade away into her boring everyday job at PhRMA disguised as mild-mannered Emily Jameson, never to be heard from again?

Stay tuned!

Images of PhRMA Intern, while not explicitly supplied by PhRMA, are used in compliance with PhRMA's "Terms and Conditions for Use of Images," and, in particular this condition: "These images may not be used to endorse a particular service, brand, commercial entity, political organization or individual and are designed to facilitate use by the print and broadcast media in an editorial or illustrative capacity in accordance with U.S. law governing such use."

Saturday, June 09, 2007

Cause Marketing via YouTube: What Pharma Can Learn from Michael Moore

Michael Moore, the creator of the documentary SiCKO (reviewed here), is entering a new realm of politics by soliciting videos from Americans chronicling their healthcare horror stories.

"I got to thinking after finishing the film," says Moore in his video pitch, "now that's there's YouTube, [I have a great chance] to ask those of you who are out there to send me your own healthcare if you videotape your story and send it here, I'll post it [on YouTube] and also take these YouTube videos to our members of Congress ...If we do this, there's a chance to get some action going."

Here's Moore's pitch on YouTube:

Moore posted his video on June 6, 2007 and already it has received over 225,000 views, 171 comments and 14 video responses.

Moore has established a group on YouTube where these videos will be displayed and discussions will be hosted. Find that here (you have to be registered member to access this area).

Together with Oprah Winfrey's "pledge" to hold a televised "Town Meeting" on people's reaction to SiCKO this summer or fall (see "Pharma's Worst Fear Realized: After Seeing SiCKO Oprah Calls for Town Hall Meeting"), this is shaping up to be a political hot potato that presidential contenders on both sides of the aisle must contend with.

What Pharma Can Learn from Moore
It's also an object lesson for pharmaceutical cause marketing.

Merck, for example, could have solicited YouTube videos from parents about their concerns regarding their daughters being infected with HPV. Selected videos could have been embedded in an unbranded web site to promulgate the need for vaccination. These personal stories -- some of which may be from women with cervical cancer -- could have galvanized state legislators to pass mandatory vaccination laws WITHOUT being lobbied in back rooms by organizations secretly funded by Merck.

I know that many pharmaceutical people hate Moore and will reject out of hand any notion that they can possibly learn something from him, but that would be a mistake.

Just a thought.

Friday, June 08, 2007

PhRMA Sent SiCKO Spy to Cannes

According to a recent report in Bussinessweek magazine, "The pharmaceutical industry received reports from Cannes, according to Ken Johnson, senior vice-president of the Pharmaceutical Research & Manufacturers of America (PhRMA), who says a friend called him from France after seeing the flick." (see "Michael Moore Wants to Reform Health Care").

Moore responded with this challenge to Billy Tauzin, CEO of PhRMA. I received this by email from The Weinstein Company, which produced the movie:
BusinessWeek today reported that the drug industry had a "friend" reporting back to them from the screening of 'SiCKO' at Cannes. Billy Tauzin, the chief lobbyist for the drug industry, doesn't need to hide behind a "friend" if he wants to see the movie. I invite Mr. Tauzin to join me in New Hampshire later this month for a screening of 'SiCKO' followed by a town hall discussion with a group of undecided New Hampshire voters. Polls have indicated that health care is one of the top issues for voters and as New Hampshire is the nation's first primary state, the screening and town hall discussion will give everyone the chance to discuss how they feel about our health care system -- and specifically the drug industry. I am guessing, given that Mr. Tauzin has launched a glitzy paid advertising campaign featuring children, that he will be more than happy to face the public directly. We can certainly discuss issues like Eli Lilly's thimerosal and what it did to America's children or the fact that New Hampshire seniors often have to cross the Canadian border to get affordable drugs.

When Tauzin was still in Congress and carrying the drug industry's dirty water -- before getting his current multi-million dollar a year contract as the nation's top drug lobbyist -- he was the symbol of the death-grip that the health care industry has over health care reform. In fact, Tauzin has a starring role in 'SiCKO' and I am sure the spy reported back on the film's treatment of Mr. Tauzin. The town hall forum will certainly offer the public a chance to explore Tauzin's record and the drug industry's role in our health care system.
Nice junket, eh Billy! You could have been more transparent like me and asked for a private screening in New York or Washington, DC and saved a lot of money. But, hey, it's much more fun to go to Cannes on pharma's dime.

I wonder who the spy was? I sense a mission for ... PhRMA Intern!

SiCKO is Boffo but Not Anti-Pharmaco, per se

While the pharmaceutical industry is part of Michael Moore's -- and many other people's -- "Axis of Evil" consisting of pharmaceutical companies, hospitals, and insurance companies, he does cut the industry some slack in his new movie "SiCKO," which I saw yesterday at a special screening in New York City. Pharma is merely a "necessary evil," whereas insurance companies are just not necessary at all -- at least the for-profit insurance industry.

Regular readers of Pharma Marketing Blog and Pharma Marketing News are well aware that I have been trying for some time to be invited to a pre-release screening of SiCKO (see, for example, "Moore: Please Don't Ignore Us Pharma Bloggers").

Finally, two days ago I received a call form the producers (The Weinstein Company) notifying me that there will be 3 or 4 screenings in New York in the coming days. I picked the earliest possible day, which was yesterday.

I must say that the PR experience was underwhelming, especially in comparison with the treatment I received at Dorland for the screening of Centocor's disease awareness movie INNERSTATE (see "Innerstate Private Screening: Philadelphia Style"). There were no producers present, not even PR people to answer any questions. I was merely greeted by a young woman who asked my name, handed me the PR material, and instructed me to take a seat in the screening room.

There were no goodies, no water even, but the seats were plush, living room-style upholstered chairs. The latter were much more comfortable than the conference rooms chairs at Dorland!

There were only about 3 or 4 of us in the audience. Frankly, I was expecting more reporters and bloggers to be there.

I've been reading for some time about how Moore et al will be reaching out to bloggers in Washington, DC and San Francisco. If my NYC experience is any indication, this hastily prepared PR effort to "reach out" to journalists and bloggers, hardly did the PR about the effort justice. Perhaps the NYC-area bloggers are not as important as are the DC-area or SF-area bloggers.

Or perhaps us pharma bloggers are not as important to Michael Moore as we thought.

One hint that this may be the case comes from a statement in the press materials:
"While major pharmaceutical firms are profit-obsessed corporations that bankroll Washington politicians and often lie about their research and development costs, the filmmakers viewed prescription drugs as 'a necessary evil' that may ultimately help patients. The same can be said for hospitals-though they, like Pharma, should be regulated and run more efficiently, people obviously need them.

Such allowances, however, couldn't be made for private insurance -- 'a completely unnecessary factor when it comes to health care,' says Megan O'Hara, one of SiCKO's producers. To make his point even more emphatic, Moore decided not to concentrate his efforts on the 45 million Americans who lacked medical insurance, but instead on the majority who are covered and were denied benefits or became strangled with ridiculous bureaucratic red tape."
SiCKO does indeed focus on the health insurance industry with only a few references being made to pharmaceuticals. It does, however, blast Billy Tauzin, CEO of PhRMA, for his support of Medicae Part D legislation and his subsequent reward from the drug industry of a $2 million salary.

I particularly liked the video clips of Tauzin in late night Congressional sessions challenging other lawmakers with "no one here loves their momma better than me." He sounded like Al Jolson!

But, as promised, SiCKO is not about Moore confronting CEOs and other corporate bigwigs as he does in his other movies. Pharma had feared this would happen when SiCKO was just a gleam in Moore's eye: Ken Johnson, senior vice president of the Pharmaceutical Researchers & Manufacturers of America (PhRMA) trade group told a journalist that industry executives were "freaking out and pulling their hair out." Indeed, Big Pharma went on lockdown. "Michael Alerts" were sent out to company employees working for at least six major drug companies, warning them to watch out for Moore and his film crews. "We ran a story in our online newspaper saying Moore is embarking on a documentary - and if you see a scruffy guy in a baseball cap, you'll know who it is," a Pfizer spokesman told the L.A. Times. Late last year, CNBC reporter Mike Huckman noted "the level of paranoia was extreme" when he covered a drug company's analyst conference, questioning the reason for the high anxiety as "The Michael Moore Effect."

Moore does believe, however, that pharmaceutical companies should be more regulated "like Con Edison," which I take to mean government oversight of drug pricing.

But he does not dwell or even mention price controls in SiCKO.

His approach is very similar to the approach Centocor took in its INNERSTATE "drugumentary": he focused on real problems of real people and let them tell their stories. I dare say that any one reading this could find him or herself in the shoes of one of these people some day, God forbid.

Take the fifty-plus year old couple who had to move into a single room in their daughter's basement after they went bankrupt paying medical bills. The father had multiple heart attacks and the mother had cancer, I believe. Both had good jobs -- the wife was a newspaper editor and the husband a machinist -- and "good" medical insurance, which maxed out and left them high and dry -- or rather low and wet in their daughter's basement.

The film focused on these kinds of Americans, although it did start out with an uninsured guy stitching his own wounded knee -- pretty gory! But, as Moore says, this is not a film about the 45 million Americans without health insurance; "it's about the rest of us 250 million Americans with insurance."

SiCKO's main message is that the profit motive should be removed from health insurance, presumably by having a national health insurance program as they do in the UK. The movie documents how health insurance companies deny coverage to maximize profits, which, Moore reminds us, is a fiduciary responsibility of all corporations with stockholders.

Moore visits several other countries that have national health insurance, including Canada, the UK, France, and Cuba. All but Cuba are rated superior to the US in health care quality by the World Health Organization. A clip in the movie from a British news story claims that the poorest British citizen has a longer life expectancy than the richest American.

SiCKO attempts to counter all the familiar arguments against national health insurance: lack of care, physician dissatisfaction, etc. It does this by interviewing people like the GP in the UK who owns a late model Audi and a $1 million apartment in London and whose annual salary (including benefits) is about $200,000. How does he rate this? Outcomes, my friend, outcomes. If his patients do better, he makes more money. But let's not focus on this and move on with my review.

Not that such anecdotal evidence proves anything, but it really makes a good impression when you hear these stories from real people rather than from PhRMA or the AMA.

BTW, Moore also blasts the AMA on this issue, especially during the "Hillary" years when then first lady Hillary Clinton tried to implement a national health insurance program. AMA, claims Moore, orchestrated an all out attack along with other self-interested parties to defeat Hillary's efforts. And Moore doesn't spare Hillary, who he claims was bought by the healthcare industry for the sum of about $800,000 in campaign contributions.

So, surprise! Moore and Hillary are not a pair!

SiCKO will give many people something to think about and cry about. I'm not going to get into the crying here except to say that at many points in the movie, there wasn't a dry eye in the screening room!

One thing I left the movie thinking about is how can Americans change this so that, as Moore says, there is more "we" than "me" inherent in how health care is managed in this country?

"Remember how we all felt right after 911?" Moore asks at one point. He was referring to the sense we all had of being "we" Americans and sharing what we have with others in order to survive and flourish. Although this feeling was short-lived after 911, Moore suggests that that was the feeling in Britain after WWII -- when the country was devastated by war -- that led to its National Health System (NHS), which is, it seems, beloved by the Brits. "If anyone were to suggest that we get rid of NHS," said one former British Labor party member, "there would be a revolution."

Will it take another American Revolution to change our healthcare system? No necessarily. It may only take one person.

That was my other takeaway from SiCKO: one person can make a difference.

Speaking to an older conservative Canadian riding around in a golf cart, Moore discovered that the most revered person in Canada is NOT Wayne Gretzky, but Thomas Clement Douglas. Looking up the history of the Canadian health system in Wikipedia, I find that Douglas introduced universal public medicare to Canada. Mysteriously, Moore did not say much about Douglas in his film -- perhaps due to the fact that Douglas was a socialist, albeit a democratically-elected socialist.

Of course, socialism (democratically elected or not), is the great bogey straw man that AMA raised against Hillary in the 1990s and which has been consistently raised every time national health health care is discussed here in the US.

Moore points out that we already have socialism here, but would never call it that. His examples are fire departments -- we never pay to be rescued by firefighters; they are our heroes -- and public schools.

Speaking of firefighters and heroes, SiCKO exploits the lack of health care received by some 911 volunteers. We all know by now the story of how the movie shows these people getting expert care in Cuba. Aside from the propaganda value, you have to shed a tear seeing Cuban firefighters standing at attention to greet and hug the Americans saying all firefighters and 911 volunteers are "family."

Too bad we are not "family" when it comes to treating fellow Americans. That a hospital can get away with dropping off indigent women in skid row rather than treating them is a travesty, no matter whose "family" you belong to -- conservative or socialist or in between. That, I think is the main takeaway from SiCKO that Moore desires us to have.

Thursday, June 07, 2007

Villanova Scientists Prove that DTC Spending Does Not Impact Rx Prices

According to Jim Edwards at BrandweekNRX, "The boffins in the business school at Villanova University are touting a formidable study with this headline: DTC advertising has no effect on the price of drugs" (see post).

Here's the elegant proof cited in the report, which you can download here:

"where it q is the quantity sold for brand i in time t (in 000s), it p is the price of brand i at time t (in dollars per unit), the lower case advertising variables represent the flow or current period advertising (in $000’s), the upper case advertising variables represent the current stock of advertising up to time t (in $000’s), it Exper is the number of months that drug i was on the market prior to time t , and it cp is a weighted average of competitors’ prices at time t . We take logs of both price and quantity so that 1 β represents the price..."

And so on. I think you get the drift.

Order your T-shirt today. Only $99.95 in the U.S. ($6.95 elsewhere in the world):

Wednesday, June 06, 2007

Avandia Hearing Soap Opera: Ethics, Demagogy, Sensationalism, and Threats by GSK

Almost as soon as Dr. Nissen began his testimony today before Congressman Waxman's Committee on Oversight and Government Reform, he commented that the Committee's work was "clearly the right thing to do."

Rep. Darrell E. Issa (R-California), on the other hand, clearly considered the Committee's work a political circus. Another congressman called it "sensationalism."

But Dr. John B. Buse, a nationally noted diabetes specialist, took center stage with his revelations about how he was treated by GSK several years ago after warning the FDA about Avandia's cardiovaascular problems.

Buse claimed that after he voiced his concerns about Avandia several years ago (1999), a GSK (SmithKline Beecham at the time) employee called him and said the company was upset. He threatened Buse and said he may liable for the multi-billion dollar market de-valuation in GSK stock that his public comments caused.

According to Buse, GSK had a "disturbing" conversation with the chairman of his dept at the University of North Carolina in which GSK characterized Buse as a "liar" and "for sale."

Buse was forced to sign a "clarification" statement, which GSK wrote. He followed up with a "please call off the dogs" letter to GSK.

Waxman later asked a GSK witness -- Moncef Slaoui, Ph.D., Chairman, Research and Development, GlaxoSmithKline -- who threatened Buse. Dr. Slaoui confirmed it was his former boss -- Tachi Yamada -- who is now doing penance at the Gates Foundation.
[For more details on this, see Ed Silverman's informative post "Will Glaxo Sue Steve Nissen For $15 Billion?" in which he points out that Nissen caused much more damage to GSK stock's valuation than Buse ever did!]
Republican committee members repeatedly focused on Nissen's communications with "majority members" of the committee before publication of his NEJM report. Nissen said he spoke to several members in Congress in February, 2007, not just Waxman and his staff.

Waxman clarified that Nissen approached many Congressional committees, but Waxman did not give him any help.

Congressman Issa asked why Nissen didn’t include studies in which no patients had a heart attack, assuming that all those zeros would decrease the significance of Nissen's findings. After he didn't get the response he wanted, Issa rephrased his question to force a yes or no answer which would have forced Nissen to admit that he and Waxman planned on leaving out important data in his meta analysis.

At which point Waxman accused Issa of "demagogy," which wikipedia defines as "a political strategy for obtaining and gaining political power by appealing to the popular prejudices, fears and expectations of the public -- typically via impassioned rhetoric and propaganda, and often using nationalist or populist themes."

Issa was probably appealing to the expectations of the pharma industry rather than those of the general public.

The Sensationalism Issue
Congressman Chris Cannon, Utah (R-Utah) tried to make Nissen cry about all the money pharma companies lose when the public hears bad news about drugs or the industry -- in other words, he thought the messenger, not the message should be blamed.

The congressman, in fact, went all the way back to the Clinton era to make his point -- which seems to be "loose lips sink drug ships."

"Do you have a concern about drug stock devaluation in reaction to your report?" he asked Nissen.

Nissen stuck to his guns and encouraged everyone to read what he said, because he was very measured and took into account the effect it might have on patients. Besides, said Nissen, "I don't follow waht stocks are doing."

Nissen dismissed the alternative -- not publishing -- as unethical, as if a congressman would relate to such an argument!

Cannon continued his offensive and accused Nissen of creating this sensationalist hearing to "whack" the drug industry.

Mild-mannered Rep. Elijah E. Cummings (D-Maryland)( said "I hate it when witnesses are attacked especially when they are trying to be the best they can be. Putting politics over the health of the American people bothers me," he said.

When Buse finally got a chance to respond to Issa's warped questioning tactics, he pointed out that everyone, including GSK, is getting the same response when they do meta analyses, no matter what data they include. "You cannot get any data from trials where there is no data, no matter how logical it may seem," he said.

Issa claimed that Nissen's analysis is biased because it left out data from trials with no heart data. He thought that science still needs to work on it. Sounds to me that Issa needs some work to do on understanding the scientific method.

Waxman concluded: "If FDA and GSK had listened to you [Buse] 7 years ago, we would have had a more definitive answer than we have today."

Avandia Hearing Begins with Slurs Against NEJM and Majority Members

It seems that the drug industry's lobbyists have been hard at work to disrupt Congressman Waxman's Committee on Oversight and Government reform hearing on Avandia before it even began!

It all began congenial enough and it even appeared that witnesses would be allowed to talk without first being attacked by members of the committee.

Alas, that was not to be.

Waxman at first announced that witnesses would be heard without any opening statements from Committee members. But then he opened up a can of Whump by inviting one committee member to speak on the special need for minority involvement in the regulatory process.

Then, all hell broke out when a Republican member attacked the NEJM for publishing "anecdotal" evidence. He also implied that ranking members of the Committee were in cahoots with Dr. Nissen, the scientist who lead the Avandia meta study, the results of which were published in the NEJM.

Von Eschenbach went on the usual FDA defensive and talked about team approach, process improvement, blah, blah, blah. At least his testimony was short.

Waxman then laid into him with a littany of instances when the FDA was warned about Avandia's cardiovascular problems, but did nothing. "Missed opportunities," he called them.

Von E emphasized the need to get drugs approved more rapidly and claimed FDA was engaged in post-marketing surveillance of Avandia.

But Waxman would have none of that. He wanted to know if FDA asked for special studies on CV effects.

Von E then handed the argument off to an underling, the scentist (Dr. Jenkins) that headed up the FDA approval team for Avandia. FDA had to admit that it did not ask for a study specifically for CV effects of Avandia. Meanwhile, the Europeans asked for such as study -- the RECORD study. But Dr. Jenkins hinted that the FDA had "more data." This data probably exists in the same vault as the data Bush has about Iraq's weapons of mass destruction.

Another Reuplican committee member Davis asked about surrogate endpoints. The basis of approval of Avandia was based on its ability to lower blood sugar, not prevention of death. He allowed Von E to state that if a preventioon of death outcome was used as a basis of approval, it would have taken 25-30 years to get approval and in the meantime thousands of people would have died. Neither Von E nor the Congressman mentioned that diabetes patients have other drugs that they could have taken.

More later...

Avandia Hearings Live Video!

Sorry! The hearing is adjourned. See "Avandia Hearing Begins with Slurs Against NEJM and Majority Members" and subsequent posts.

Moore, Oprah, SiCKO: The Video

Yesterday I related that Oprah called for a town hall meeting on the state of US healthcare in her interview with Michael Moore, the producer of the moview SiCKO (see "Pharma's Worst Fear Realized: After Seeing SiCKO Oprah Calls for Town Hall Meeting").

Here's the video of that interview.

Part 1

Part 2

Tuesday, June 05, 2007

Pharma's Worst Fear Realized: After Seeing SiCKO Oprah Calls for Town Hall Meeting

"This movie is very different [than other movies made by Moore]" says Oprah. "I want a town hall discussion about it. I think you [Moore] opened the door, but we need to get America talking about it. Republicans talking about it, Democrats talking about it...people who suffered talking about it ."

She was speaking on her show today with Michael Moore about his film "SiCKO", which won critical acclaim in its Cannes debut.

Moore suggested that like fire departments, health care should not be run for profit.

"Health care should be guaranteed to every American, remove the profit from the system, and regulate the pharmaceutical companies."

While More was uttering those words, Oprah could be heard saying "yeah, yeah" and her audience applauded vigorously.

"This is what I think is really great," Oprah said. "What you say at the end of the film. Make this country more about 'we' than about 'me'. Thank you for making that point."

Enough said!

P.S. Michael, I'm still waiting for that private screening!

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."

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.
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