Friday, November 30, 2007

Counter Detailing -- Pissing into the Wind or Profitable Endeavor?

Pissing into the Wind: Engaging in a pointless activity.

That's how I see Dr. Dan Carlat's new focus on redeeming himself by engaging in some freelance "counter detailing" in his home state of Massachusetts.

You'll recall that Carlat recently wrote a true confession of how he earned $30,000 as an MD shill for Wyeth a few years ago (see "Dr. Carlat's True Confession: 199,999 More to Go").

Many people called for him to give the $30,000 to charity or back to Wyeth, but Carlat demured.

Carlat explained on his blog and in an interview with Ed Silverman over at Pharmalot that "I'll be doing the opposite of what I did with Effexor, which was to give drug talks. Instead, I’ll be visiting different doctors, different practitioners in different places in the area and try to educate them about direct-to-consumer advertising, evidence-based medicine and treatment options."

He will do this on his own time, but only "until my 30K runs out." If he "bills" himself for his time at the same $450 per visit rate he did for Wyeth, he would have to visit about 67 docs. That's assuming he gets past the receptionist every time he tries, which is not likely because he vows that free lunch is not included. Will he bill his failed calls at the same rate as his completed calls? Real pharma detailers do -- ie, pharma reps are paid whether they see the doc or not.

Let's say 50% of physicians let him in. That means Carlat will end up speaking to only about 33 physicians.

While Carlat is "counter detailing," actual pharma reps are out there detailing and offering many goodies to docs that counter detailers like Carlat can't offer -- eg, free samples. Detailers can also offer glossy reprints of medical articles, pens, calendars, free CME, and, of course, free lunch. With these incentives, many Wyeth reps claim they do not have a problem accessing physicians and I am sure their success rate is greater than 50%.

How many detailers are out there in Carlat's territory? Let's just focus on the Wyeth reps and assume there are 5,000 of these in the US that visit psychiatrists. There's bound to be several hundred just in Carlat's territory competing with him.

Let's also not forget the 199,999 other physicians hired by the drug industry as consultants. Wyeth could easily deploy some of these to counter Carlat's counter-detailing effort.

Who knows, Wyeth may even try some "stealth counter-counter detailing" by sending out docs to visit other docs on their own, claiming to be counter detailers with outcomes data that are favorable to Effexor.

Even though I am not serious about the stealth stuff, the thought leads me to ask what credibility does Carlat have as a counter detailer? He doesn't seem to plan to work within an organization like the Alliance for Human Research Protection, which funds Dr. Jerome Avorn's counter detailing project in PA (see "Counter-Detailing Anti-drug Reps Coming to Educate Doctors"). He's a lone wolf counter detailer!

The Book
Here's what I think. Dr. Carlat is working on his tell-all book. His true confession AND his counter detailing mea culpa will offer some great feedback and experiences to write about. From this I expect Carlat to reap a hell of a lot more than $30,000!

If true, then Carlat's counter-detailing stream has an associated rainbow.

P.S. Carlat IS a member of the National Physician's Alliance, whose mission he describes in his blog:
"By the way, several physicians at the National Physician's Alliance (NPA) are available for free talks on pharmaceutical industry influence, and they span the specialties, offering counter-detailing on treatments in internal medicine, cardiology, pediatrics, etc.... And join NPA while you're on their site. Unlike the AMA, they will never sell your name to drug companies."

Wednesday, November 28, 2007

True Confessions Redux: Another MD Shill for Pharma Outed

Yesterday, I wrote about Dr. Carlat's confession of being a shill for Wyeth (see "Dr. Carlat's True Confession: 199,999 More to Go"). As a follow-up, I decided to see what Carlat is saying on his blog and what drugs reps are saying on Cafe Pharma.

Carlat recounted some feedback under his post "Return the 30K, You Cheap Thief", which was inspired by a comment made to the WSJ Health Blog. In my critique, I never suggested that Carlat give back the money. He did, after all, take time off to do lunch-and-learns. Many reps in the Wyeth Company board over at Cafe Pharma, however, suggest that these gigs usually involve little or no work at all and may even be counterproductive (see below).

Regarding giving the money back, this is Carlat's retort:
"I'd be curious to hear opinions about: A. Whether I should return the dirty money; and B. Where it should go if I can bear to part with it?"
Here's my opinion: If you decide to write a book and get an advance on royalties, I'd say you should donate $30,000 to an appropriate charity or patient support group -- one that does NOT usually get money from the pharmaceutical industry. You can make pretty good promotional hay out of it and easily recoup the $30,000 from additional sales of the book! Maybe I can be your agent...give me a call.

Here are some comments from the "field hands" (aka, Cafe Pharma posters):
"Many hookers and paid escorts have written their memoirs in the past. It will continue. It allows them to 'purge their conscience' and sell themselves in a different area."
Nice to see my ho analogy also used by sales reps. I wonder if there is a little black book out there that names the "johns"? Who are the "johns" anyway? The doctors that were served the lunch and swallowed the pitch, I'd say.

Surprisingly, many reps -- perhaps NOT all of them Wyeth reps -- were happy Carlat wrote his confession:
"I am glad this doctor wrote this article. I, for one, hate hate hate doing speaker programs, especially with the crappy and antiquated slide decks we have. They are a waste of time, resources, money, and since I don't have many access issues, and these slide decks have nothing new in them, what is the freaking point????????"
Clearly, this rep needs to be fired! There's likely to be a great ROI on these lunch-and-learns, as I pointed out in my post yesterday. But it's nice to know this rep hasn't got access issues. Does he/she close deals and get more scripts written?
"I'm glad the good Dr. wrote the story, and hope it causes much more damage to Wyeth's reputation, if that's even possible. Does not matter how many people do it...bribery and fraud is just that, bribery and fraud. I've witnessed it myself, reps knowingly doing speaker programs to line their Dr.'s pockets with cash for a quid pro quo. There is very little educating going on at these programs most don't even adhere to the guidelines Wyeth claims to strictly enforce. Sorry, it’s black/white the way I see it and what I see is crime."
Dr. Norm Sussman is Outed!
As for other physicians confessing their sins, here's what Carlat claims:
"Many physicians wrote their own mini-confessionals about giving drug talks. One doctor, also a reformed Effexor speaker, described a teleconference in which Norm Sussman minimized withdrawal problems with Effexor. In response, the doctor had an "ethical lapse" and couldn't help mentioning to the audience that Lexapro might be an easier drug for primary care doctors to prescribe, much to Sussman's annoyance. The writer eventually quit speaking for Wyeth."
A rep on the CafePharma Wyeth discussion board also outed Sussman:
"As I see it, any practicing physician who does what I do could be viewed as a whore (therefore, making you his pimp!!!). He is being asked to deliver canned information but is sternly discouraged from interpreting this information.

"If anyone should be outed here, it is DR SUSSMAN, KING OF THE WHORES!!! In the world of psychiatry, Dr Sussman is more than willing to wine and dine your most (self) important Drs in his luxurious offices overlooking 5th Ave (unless you work for Eli Lilly!!!) for a substantial. He will pretty much tout your drug (except Prozac and Zyprexa) to just about anybody at anytime (not quite anywhere though, the NYC business is plenty fine for him, although, FL and CA aren't off limits). A few years back he did a program for me (I do not and never have worked for Wyeth). After scheduling the program, he called me back shortly before the program to say that he needed to do a teleconference for Glaxo right after my program and asked if the restaurant had a space for him to do it. Considering his "reputation", how could I say no. Doubledipping. We paid at lest $2k plus a limo out to LI. I soon found out thought that for every Dr who was thrilled to hear Dr Sussman speak, there was a Dr commenting that he was "shilling" for us too and that he was going to tell everyone why "our" drug was so much better than all of the other a-ds. Estimates are that he makes over $500K doing this. That is f**king obscene."
Sorry for editing the language -- as I and Confarta sales rep Charles Charles have noted many times, Cafe Pharma denizens are apt to spew potty words at the drop of a dime:

Tuesday, November 27, 2007

Dr. Carlat's True Confession: 199,999 More to Go


Dr. Daniel Carlat knew his career as an industry-sponsored speaker (aka, industry ho) was over when the Wyeth district manager (aka, pimp) who first hired him said: "My reps told me that you weren't as enthusiastic about our product at your last talk. I told them that even Dr. Carlat can't hit a home run every time. Have you been sick?".

That is just one of the many tidbits into the life of an "industry-sponsored (MD) speaker" Carlat offered in a lengthy New York Times Magazine story published this past Sunday (see "Dr. Drug Rep").

"Regardless of how I preferred to think of myself (an educator, a psychiatrist, a consultant), I was now classified as one facet of a lunch helping to pitch a drug, a convincing sidekick to help the sales rep." Sidekick does not accurately describe the relationship between pharma reps and MD "consultants." With all due respect to Dr. Carlat -- who at least has confessed his past sins -- I prefer ho.

Dr. Carlat, a practicing psychiatrist, newsletter author, and anti-pharma blogger over at The Carlat Pschiatry Blog, first came to my attention when he wrote an NY Times OpEd piece about CME (see "Welcome to the CME Laundromat!"). I even invited him as a guest on my Pharma Marketing Talk podcast show (listen to it here).

I feel a little betrayed that he never disclosed to me his past as a paid consultant to the pharmaceutical industry, which raises the question: Should the other 199,999 physicians that Carlat estimates receive money from pharmaceutical companies also come out of the closet and reveal their current or past ties to the industry?

This kind of disclosure is something I have called for in the past (see "Dollars for Docs: More Scrutiny Needed") and my readers wholeheartedly agree (see figure at left; you can give me your opinion by taking the poll yourself:

Should Pharma Companies Report Physician Consultant Fees?
Yes, we have a right to know
No, that's confidential business information
No, that's up to each physician to reveal
Not sure
I really do not expect pharmaceutical companies to voluntarily rat out their MD hos, er consultants. Maybe there should be a call from the AMA for that or for doctors to reveal their ties so their patients can know. But, as Dr. Carlat points out, the AMA is part of the problem:
"The American Medical Association is also a key player in prescription data-mining. Pharmacies typically will not release doctors’ names to the data-mining companies, but they will release their Drug Enforcement Agency numbers. The A.M.A. licenses its file of U.S. physicians, allowing the data-mining companies to match up D.E.A. numbers to specific physicians. The A.M.A. makes millions in information-leasing money."
Like many physicians, Dr. Carlat claimed to have been "astonished at the level of detail that drug companies were able to acquire about doctors' prescribing habits." As if it were some kind of trade secret! Duh!

Is a Book Deal in the Works?
So, one physician has disclosed details of his past life as a drug industry "consultant," "sidekick," "ho," whatever. Any comments from the 199,999 others? I'm not holding my breath for that. But I am expecting Dr. Carlat to write a tell-all, semi-fictional book about his experience in a similar vein to Jamie Reidy's book "Hard Sell: The Evolution of a Viagra Salesman" (see "Generation X Pharma Reps").

Some Numbers
BTW, the NY Times Magazine piece includes a graphic illustrating how one paid "consultant" can help a drug company get about 25 new patients on medication per lunch-and-learn physician the consultant influences. This costs the pharma company $500-$750 paid to the consultant (an "honorarium"), $100 for the lunch, and maybe $400 for rep expenses. Total = $1250 or $50 per new patient. Considering that Effexor must be taken for years and years, that's quite a return on investment! Dr. Carlat should have negotiated a much higher honorarium, IMHO!

Monday, November 26, 2007

Vytorin Study Stallin' - Notes from the Field Hands

As reported on Forbes.com (see "The Vytorin Question"):
"Every day millions of people swallow Zetia and Vytorin in the hopes of reducing their risk of heart attacks and strokes, generating $5 billion a year in sales for Merck and Schering-Plough, which produce them.

Do they work?

Despite millions of prescriptions, no study has ever shown that these $3-a-day pills prevent heart attacks, strokes or deaths any better than just taking older, cheaper drugs like Pfizer's Lipitor or Merck's off-patent Zocor, even though they're proven cholesterol fighters. That's why a two-year delay in a 900-person study aimed at clarifying the issue has cardiologists expressing skepticism and spinning conspiracy theories. If the news were good, the companies would rush it out, the thinking goes. Delay doesn't bode well."
At issue here is whether or not adding Zetia to a statin (as in Vytorin, which combines Zetia with Merck's Zocor) reduces plaque in arteries and therefore would help prevent heart attacks and strokes. Zetia has been shown to further reduce bad cholesterol in the blood when combined with Zocor; ie, "In a clinical study, people who added ZETIA to their statin medicine reduced their Bad Cholesterol by an additional 36 points (25%) compared with 6 points (4%) in people who added a placebo (a pill with no medicine)," according to information on the Zetia Web site.

These days, reducing bad cholesterol is not good enough, especially with the FDA more focused on improving real outcomes -- ie, reducing death rates. Hence, the ENHANCE study, which was designed to get a new indication for Zetia -- reduction of plague in arteries.

As this story wends its way around the Pharma Blogosphere, I thought it would be interesting to see what the Schering-Plough and Merck sales reps are saying about this over at Cafe Pharma. A list of recent threads suggest the general tenor:
Here are some tidbits:
"Nice explanation 'there are confounding variabilities in the observation of the target arteries and we needed to streamline the observation process'

Translated for all of you kool aid drinkers:

The initial blinded readings of the target lesions showed no benefit in terms of progression of disease by being on the Vytorin 10/80 vs. Zocor 80mg, therefore we fired all of the idiots that read the imaging studies without bias and hired some folks that know how to look for some frickin' benefit in those Vytorin patients" . Now the first time the new folks looked at the data they found "some" benefit but we informed them that there was "MORE" benefit to be found. So we shipped their asses out to a "RE-Training Facility" in Fargo, ND last December and made sure they understood "where & how" to find that slowing of progression and regression. Now we expect the NEW Findings to be presented at the Acclaimed ACC meeting in March 2008."
"In today's environment Merck will not pull this off. The days of spinning the data are over. If anything they will just try and make the data go away so as not to disrupt the current revenue stream. Changing the end point is not a good idea, ethically or politically."
"I used to have high respect for Merck reps and I competed against you, didn't always win didn't always lose but I knew one thing the reps were ethical and stand-up. Merck used to have the highest ethical, scientific base from which to stand and look down on the rest of Pharma (especially Pfizer) for just being "MARKETERS", looks like that Moral high ground is starting to shift. I use as examples the disgraceful coverup and minimalization of the VIGOR data and APPROVE data and NOW ---- ENHANCE."
It does appear that Merck is attempting to squeeze some positive data from the study by selection of new endpoints. It's a similar ploy to the one currently being used by the Bush administration to prove "success" in Iraq! Note to self: Find out if Merck is a big supporter of the Republican party and past Bush presidential campaigns.

But the following comment about how this affects the credibility of sales reps in the field really struck a chord with me:
"I used to believe everything we did was for the better science but after getting blasted by a cardiologist today because the pfizer rep had just told her all about "Merck suppressing bad data for Vytorin to milk more $$ out of the drug before the truth is released" I really just want to kick someone in the nuts for doing the damn study in the first place.

BTW since when has a coverup EVER been better than just telling the truth the first time? Answer=NEVER

Idiots in HQ don't mind sacrificing the reps' credibility who cares about the long term trust btwn dr. and rep anymore."
This is just another example of how the pharmaceutical industry shoots itself in the foot. As a side note, it is also a good example of why the pharmaceutical industry can never ever be trusted in a social networking environment.

The industry is doing a lot of hand-wringing about diminishing access to physicians. Sales tactics are being altered and consultants are being hired to "solve" this problem. But the best solution -- providing docs with honest, up-to-date information about medications -- seems to be taking second place to providing Wall Street investors a plausible reason to invest in the company stock.

One final comment.

The Zetia TV ad that features a group of residents talking about the drug's major side effects while going through hospital rounds with a teaching physician was touted as an example of how marketers are becoming "more creative in using physicians as authority figures in broadcast spots" (see here).

I wonder what real teaching physicians are saying about Zetia these days?

Wednesday, November 21, 2007

Pharma Marketing News Preview

Focus
Online DTC, Adherence, Medical Transcript Advertising, Web 2.0 Regulatory Framework

Mapping New Paths through the DTC Marketing Mix Maze: Integrating the Power of Non-Traditional Media
On one hand, pharmaceutical marketers allocate a disproportionately larger share of their advertising budgets to broadcast media (TV and radio) than do most other industries—70% versus the overall average of 54% based on 2006 TNS Media Intelligence data. On the other hand, it is a well-known fact that pharmaceutical marketers allocate a much smaller part of their ad budgets to the Internet channel than do most other industries. The majority of consumers now rely more on the web and word-of-mouth than on traditional media for their health information.

All this begs the question, are pharmaceutical marketers optimizing their media mix to take advantage of the consumer contact points offered by new and non-traditional media such as blogs, WOM, texting, etc.?

In this article, David Kweskin, Senior Vice President and Practice Area Leader, Brand and Communications Division, TNS, explains how his company helps marketers look across the full spectrum of media—traditional media like radio, TV, print—and and gives them a common way of measuring them against new media like blogs and word of mouth. Meanwhile, Morgan Lozier, Director, Web Evaluation Brand and Communications Division, TNS, presents a review of 3 erectile dysfunction product websites to illustrate what the online DTC experience should look like. He finds one winner among the contenders.

Accomplishing Adherence: Chase Compliance, Pursue Persistence
Lack of adherence -- the combined effect of compliance and persistence -- is a big problem for the pharmaceutical industry. James Chase, editor-in-chief of MM&M, once wrote "To say that tackling patient compliance and persistence poses a challenge to the pharmaceutical industry is like calling Tiger Woods a competent golfer or describing Katrina as a particularly bad storm. It is a gross understatement."

This article reviews presentations made at the recent eyeforpharma Patient Adherence and Persistence Summit including a presentation by David Baker, VP & General Manager of Shire's ADHD Business Unit, who presented on "Best Practices for Fostering Adherence." He used the ADHD market as a case study.

Medical Transcript Advertising: Reach Targeted Physicians at the Point of Care
With roughly 100,000 pharmaceutical sales representatives knocking on doctors’ office doors every day, the increasing workload of physicians, and states imposing restrictions on sales rep activity, it is harder and harder for pharmaceutical companies to reach prescribers with their marketing messages. There is also the expense of using "live" sales reps, which can range from $200 to $500 per call.

All this underscores an ever-increasing need to reach physicians with brand messages and reminders through "non-personal" marketing techniques that do not directly involve sales reps.

This article reviews advertRx™, a solution offered by datumRX, a California-based company that specializes in aggregating clinical data and medical records. advertRx™ reaches physicians with targeted brand messaging by inserting Rx product logos on medical transcripts containing key words, relevant to the product.

Web 2.0 Regulatory Framework: A Critical Analysis
At the recent eyeforpharma "2nd Annual eCommunication and Online Marketing" conference, Fard Johnmar (Founder, Envision Solutions), Jim Nail (CMO, TNS Media Intelligence/Cymfony), and John C. Serio, (partner, Seyfarth Shaw LLP) talked about regulatory issues relating to Web 2.0 and summarized a new social media monitoring and marketing framework for pharmaceutical companies ("New Social Media Marketing Framework White Paper"). This article takes a critical look at the "Framework" and offers further insights into the regulatory issues it raises.

Anticipated Publication Date
28-November-2007

Ad Submission Deadline Date
21-November-2007
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Monday, November 19, 2007

Dr. Buse Under GSK's Thumb! How Pharma Uses CME Funding as a Weapon.

"I was certainly intimidated by them... It makes me embarrassed to have caved in several years ago."

That's what Dr. John Buse, a diabetes expert and professor at the University of North Carolina, had to say about the treatment he received at the hands of GSK after he criticized Avandia, a drug GSK manufactures to control glucose levels in diabetics.
The details of Buse's knuckling under GSK's thumb were revealed in a report by the United States Senate Committee on Finance (see "The Intimidation of Dr. John Buse and the Diabetes Drug Avandia").

At one point, Dr. Buse wrote to a GSK executive "Please call off the dogs. I cannot remain civilized much longer under this kind of heat."

Implications for Independent CME
The "heat" he was referring to was repeated calls to Fred Sparling, Dr. Buse’s department chairman. This is significant because there were threats to cut off funding for CME programs and a national survey of department chairs at medical schools and teaching hospitals found that more than half have relationships with industry, including receiving financial support, research equipment and consulting fees (see "Industry Influence Over Academia Should Be Studied").

In June 1999, GSK executives discussed Dr. Buse in a series of emails they titled, "Avandia Renegade." One email reads:
[M]ention was made of John Buse from UNC who apparently has repeatedly and intentionally misrepresented Avandia data from the speaker’s dais in various fora, most recent among which was the ADA.

The sentiment of the SB group was to write him a firm letter that would warn him about doing this again..with the punishment being that we will complain up his academic line and to the CME granting bodies that accredit his activities….The question comes up as to whether you think this is a sensible strategy in the future (we don’t really do too much work at UNC to make any threats).
In other words, GSK threatened to cut off Dr. Buse's CME funding and would have also threatened UNC funding if only they did "much work at UNC."

Afterward, Buse caved in and signed "some legal document in which I agreed not to discuss this issue further in public."

Later in 2000, Dr. Buse reached out to GSK officials, asking them to sponsor a continuing medical education (CME) program about TZD use. Dr. Buse wrote an intriguing request to get $ from GSK for CME, which he said would put an end of the "glitazone wars":
I spoke to Rich Daly, the head of marketing (and sales?) for Takeda. He was going to run the idea of joint support for the CME program by the Takeda lawyers to make sure there are no FTC issues in what I proposed. I highlighted to him that the benefit to Takeda and [SmithKline Beecham] would be the potential to grow interest in the class as a whole and as a very public display of the end of the "glitazone wars."
By late 2000, GSK officials appeared to believe that they had the former "Avandia Renegade" under control.

At that point, I'd say GSK executives were singing the classic Stones song "Under My Thumb" whenever they thought about Buse:

Friday, November 16, 2007

Merck to Vioxx Plaintiffs: Settle or Else!

Read in the Wall Street Journal today:
Plaintiffs in litigation over the painkiller Vioxx are supposed to be able to decide whether to enroll in the ├╝bersettlement announced last week or take their cases to court. But due in part to what lawyers say is an unusual provision in the settlement agreement, many plaintiffs in effect may have little choice but to accept the deal.

The provision, agreed to by Merck & Co. and the lead lawyers in the case, requires that if one client of an attorney enrolls in the settlement, then the attorney must recommend the deal to all other clients. If a client decides not to take part in the settlement, then the lawyer, according to the deal, must take "all necessary steps" to withdraw from representing that client. It is relatively rare for a settlement to require lawyers to cut ties with clients, but it appears to be happening more often, lawyers say.

Some find the development problematic. The provision improperly "stacks the choice for the client," says Deborah Rhode, an ethics professor at Stanford Law School. "If the price of exercising what should be their right to reject the settlement means they have to forfeit their representation from the lawyer actually familiar with the case, it's not exactly an uncoerced choice."
Read more about this here (subscription may be required; you can also try here).

Is Money Being Wasted on Syndrome's Treatment?

There's been a lot of criticism of the Consumer Reports (CR) Adwatch video segment that satirized the ubiquitous Requip TV ad (see this post to Pharma Marketing Blog). Requip is a GSK drug approved in 2005 for the treatment of "Restless Leg Sydrome" (RLS).

I have to agree with most of the critics who complained that the CR video was a sophomoric attempt at humor. However, CR reporter Jamie Hirsh did make one point that most critics have glossed over: 57% of sufferers get better with placebo compared to 73% on Requip.
NOTE: "Placebo" is a sugar pill. In many clinical trials of drugs, placebo happens to be a pretty effective alternative! But I digress...
Let me whip out my trusty Microsoft desktop calculator and do some math so that you don't have to.

Let's say that 3% of the US adult population suffers from RLS (the Requip website claims 10%, but I am using the 3% number because that's the number Jamie Hirsh cited and none of her critics -- including pro-DTC Bob Ehrlich of DTC Perspectives magazine -- quibbled with that estimate). This equates to about 7 million US adults.

Let's say 15% of these RLS sufferers are taking Requip. I got this figure from a GSK presentation made to Merrill Lynch analysts (here). That's 1 million people on Requip, give or take a few thousand.

I found an estimate of $500 million in US Requip sales for 2006. This comes to $500 per person treated per year. I assume all of this goes to the RLS sufferers and most of it is paid for by 3rd parties (insurers, gov't, employers), which eventually adds to all our healthcare financial burdens from taxes, higher co-pays, etc.

But what about the effectiveness of Requip vs. placebo?

If 57% (570,000) of the 1 million RLS sufferers would find relief with sugar pills vs. 73% (730,000) with Requip, that means only 160,000 people (730,000 - 570,000) actually benefited from Requip.

That's not a small number. But for our healthcare system to spend $500 million to benefit 160,000 people ($3125 per person per year) is ridiculous!
NOTE: You can also say that $285 million was wasted treating the 570,000 people who would have done as well taking a sugar pill.
BTW, how many of those 1 million people actually suffer from RLS versus how many are convinced they have it and, in turn, convinced their doctors to prescribe Requip?

If we were talking about a cancer treatment, it might be callous to do this kind of monetary analysis. You can't put a number on a human life -- although insurance companies do it all the time. I am sure, therefore, that someone besides me has done this analysis for Requip/RLS and other drug/syndrome pairings. if so, I'd like to know about it.

Thursday, November 15, 2007

Amitiza DTC Ads Won't Win Any Awards, But...

While in a hospital outpatient waiting area last week I was forced to watch "The View" on one of the ubiquitous overhead flat screen TVs that seem to be everywhere these days. Whoopi Goldberg was talking about the "ultimate gift" a mother could give a pregnancy-challenged daughter -- implanting her daughter's embryo in her uterus and delivering her child -- when she was rudely interrupted by the new Amitiza DTC ad.

For those of you who haven't heard, Amitiza is an anti-constipation drug being marketed by Takeda, the folks that bring you Rozerem and Actos. If you believe what you read on Cafe Pharma, Amitiza, which was developed by Sucampo Pharmaceuticals, Inc. -- a drug company I never head of -- is Takeda's #2 selling product (I assume Actos is #1 because Rozerem sure as hell isn't).

I can believe that Amitiza is Takeda's #2 drug. There's been a void in the woman's constipation/Irritable Bowel Syndrome (IBS) market since Novartis withdrew Zelnorm (see "Novartis suspends US marketing and sales of Zelnorm" and other articles here).

The ad could not have been better placed within the show -- interrupting Whoopi speaking to women about difficult pregnancies! Constipation is frequently associated with pregnancy.

Of course, Takeda does not want to limit the market for Amitiza just to pregnant women. Therefore, it is engaged in a bit of "disease mongering" on the Amitiza web site, to whit:

"Chronic Constipation touches the lives of up to 28% of adults in America. Both men and women suffer from it, but the condition is two to three times more common in women."

What exactly "touches upon" means is anybody's guess. Nevertheless, the 28% figure is dutifully repeated in media stories (see, for example, "Amitiza DTC seeks to move constipation sufferers").

In fact, the media go even further and cite these numbers given to reporters by Takeda: "Constipation affects 42 million American adults, and 12 million could be characterized as suffering from chronic idiopathic constipation, the condition for which Amitiza is indicated..."

Let me whip out my trusty Microsoft desktop calculator and do some math.

How many US adults are "touched upon" by "chronic constipation?" There are about 220 million US adults over the age of 20. 28% of that equals about 62 million people. Clearly, that's a much greater number than 42 million adults that are said to suffer from simple "constipation" and much greater than the 12 million sufferers of "chronic idiopathic constipation," which is a form of constipation having an unknown cause. The latter is the "official" FDA approved indication for Amitiza. All the other numbers about simple constipation and "touched upon" seem to have been thrown in to confuse us into thinking that this drug is indicated for a much larger population than the FDA gives it marketing approval for.

Back to the TV ad.

I was struck by how utterly boring the Amitiza TV ad was. This is definitely NOT the kind of ad Abelson Taylor (AT) -- the agency responsible for the Rozerem campaign -- would have done (for an idea of the print ad that AT WOULD have done, see this post).

The ad focuses on women, women's shoes, and women on the move -- by which I mean walking out of the house! The rest was totally unforgettable.

The Amitiza web site is no less boring!

But...

If Amitiza is currently the only Rx out there for chronic constipation (and soon to be approved for IBS as well) and if it is indeed Takeda's #2 drug (in sales as well as indication), then the DTC campaign does not have to be creative (ie, expensive) and "break through the clutter." It merely has to inform the target audience that Amitiza is out there and you can get it!

Given the simplicity of the TV, print, and Web ads, the ROI for the Amitiza campaign must be astronomical!

But...

Meanwhile, Zelnorm has been cleared to return to the market under limited conditions. Too bad. I was looking forward to that day when Takeda would have to rethink its campaign and compete with a new Zelnorm campaign.

I envisioned Takeda turning to AT, its top gun ad agency to break through the clutter.

Here's my concept for the new Amitiza campaign. Forget women's shoes and walking out the house! Bring in the critters! Of course, you can't use beavers or bees or moths. So, I propose "Stippy Stool" pictured on the left.

RLS Simulator: Weird Wired Science

"It's not a diagnosis machine in any way, shape, or form," said Allison, the Creative Director for the RLS simulator commissioned by Boehringer Ingelheim Pharmaceuticals, Inc. "It is an awareness piece for the physician community ... so they will have a better understanding of the science."

Allison was interviewed in a Wired Science Video: "The Business of Disease," which aired on PBS last night.

This video critique of the RLS drug marketing campaign is vastly more informative than the Consumer Reports video critique I reported on yesterday (see "RLS Foundation (aka GSK?) Calls for Boycott of Consumer Reports Over Ad Spoof").

The most interesting part of the video was when the Wired Science reporter strapped on the weird device and confessed that "It's not too bad. Just a bit of tingling. But I can imagine if I had this happen night after night, you know, for hours on end, it would bug me."

Meanwhile the thing sounded like a buzz saw! Must be those ants in there. I am sure every physician who straps this simulator on will understand the science of a vibrator, but I'm not so sure they will gain any more understanding of the "science" of RLS as Allison claimed.

Aside from seeing an RLS simulator in action, I learned that symptom diaries, which are ubiquitous on product websites, are designed to instruct patients how to frame their symptoms as a diagnosis, which makes it easy for doctors to prescribe medicine for that diagnosis. Pretty cool way of manipulating the patient-physician interaction, huh?

Richard Myer, blogger at World of DTC Marketing, was featured as the resident pharma marketing expert in the video. "Creating a need, that's what marketing is all about," said Myer. "If people don't know they have a need, create a need."

BTW, Rich owes me a favor for passing his contact information along to the Wired Science producers when they contacted me looking for an expert they could interview. Within hours of getting my recommendation, they showed up at Rich's home for filming. Need I say more about why it pays to be on my good side?

Wednesday, November 14, 2007

The "One-Click Rule": Rant or No Rant?

I had another informative day at eyeforpharma's "2nd Annual eCommunication and Online Marketing" conference in Philadelphia yesterday.

I learned a few things and collected lots of good sound bites/catch phrases relating to eDetailing ("Innovate or Die!"), Web 2.0 ("Don't get blinded by the technology"), and adverse event reporting ("Your fear is unfounded").

You can read about all that good stuff in an upcoming issue of Pharma Marketing News. Here, I'd like to focus on my "rant" about the so-called "one-click" rule in online pharmaceutical marketing.

"Rant" is the way John C. Serio, partner in the Boston office of Seyfarth Shaw LLP and a paisan with roots in Sicily (on his father's side), characterized my comments about the "one-click rule." On the left is the old school black and white photo of Serio that I found on his firm's Web site.

Serio's comment -- "Someone wrote in and went on a rant that the one-click rule was not an FDA regulation" -- was made during a panel discussion about how to overcome the regulatory hurdles to successful pharma "monitoring and marketing," which BTW is another good catch phrase.

The panel also included Fard Johnmar (Founder, Envision Solutions) and Jim Nail (CMO, TNS Media Intelligence/Cymfony).

The panelists summarized a new social media monitoring and marketing framework for pharmaceutical companies that Fard's and Jim's companies collaborated on (see "New Social Media Marketing Framework White Paper").

Rant or No Rant?
I read this white paper and had only one criticism: the "one-click rule" is no rule at all and is merely a platitude online pharmaceutical marketers spout to trick us into believing that they obey "rules." Since I spend a lot of time documenting how pharma marketers violate this "rule" repeatedly, I thought I would write a comment to the authors of the Framework. Here it is. You decide if it is a "rant" or not.
In the paper, the authors make frequent reference to the so-called "one-click rule" regarding access to fair balance information on the Internet.

If you search Google on "one-click rule FDA" you won't find any references to this rule that the FDA has made, but you will find my post "Girl from Google."

That's because, in that post, I discuss how the so-called "one-click rule" was used to justify Google Adwords (aka, "BAdwords") that violate FDA guidelines -- these ads mention the brand name and indication, but do NOT include any fair balance as is required by FDA.

One person from a pharmaceutical company, perhaps playing the devil's advocate, contended that these "BAdword" ads may pass muster with the FDA because the package insert or brief summary is "one or two clicks away." His argument was that without specific guidance from the FDA, no one knows what is correct in this case.

The "one click away" defense does not apply here. FDA says it's OK on an Rx product Web site to merely provide a link to the package insert or brief summary. In that case there is no need to provide that information on the same page that mentions the drug name and its indication.

Thus, an AdWord could be said to comply with the "one click rule" only if within the AdWord text there was a direct link to the package insert (PI) or brief summary.

In "BAdwords," there is only a link to the product Web site, not the PI. Presumably, the user would have to find the link to PI once on the product Web site.

So, if there actually is a "one-click rule," it is not correct to invoke it for every kind of ad on the Internet, and surely not in cases where you really need TWO clicks to get to the PI or fair balance!

It is a shame that the FDA does not have any guidance for the industry as far as Internet advertising is concerned. This means that marketers can use lack of guidance as a defense for sneaking in ads that push the envelope. What are the chances that the FDA would ever notice. These ads are fleeting, here today, gone tomorrow!
I posted this in a comment to the Comfy Blog on Sep 6, 2007 1:36:37 PM

Jim Nail responded:
Agreed -- there is no "official" FDA one-click rule, nor do we say there is. But there is a "received precedent" that if you have one click from your brand site to the PI or labeling information, that is acceptable. Or call it "best practice". Or call it just "common practice". In our paper we say that if you have a branded blog, social network, discussion forum, etc. have a link to the PI prominently n the navigation or other links on the site.

You raise some interesting points about search. We focused solely on the social media realm, not the "traditional" interactive realm. We only touch on other Internet marketing to make the point that marketers don't have to wait for FDA guidance to take advantage of new marketing forms.

That said, I agree. In a strict interpretation, paid search ads are probably verboten: given the space restrictions, there's no way to get any sort of "fair balance" statement into an AdWord ad.

But I think it is more complicated than that. I just Googled High Blood Pressure. A Lipitor ad pops us but only says, "Visit Lipitor.com to learn ways to lower your cholesterol." Click through and the first thing on the page is "Diet and Exercise". The second heading on the page is "Cholesterol-Lowering Medication".

I guess this is an example of one of the tricks you mention: within the confines of the AdWord text, they never make a claim or even explicity state the indication.

Are you saying that the act of buying the keyword and having their ad pop up is tantamount to including it as an indication in their ad? It would be interesting to do some consumer perception research: I wouldn't be surprised if the consumer walks away with the link between Lipitor and lower blood pressure, in which case there could well be a cause for the FDA to issue a warning letter.
Note: Jim didn't accuse me of ranting and made some interesting comments. For me, the issue with the Framework people was closed. Until, that is, Serio made his "rant" accusation and forced me to bring this up and into the open again.

BTW. I agreed with about 50% of the comments Serio made at the conference. He, on the other hand, said "when it comes to the Internet, you can only believe about half of 1% of what you read." I forgive him for that statement since he admitted that he never read a blog or heard of Web 2.0 until Fard and Jim recruited him to help them write the Framework.

However, I did agree with Serio when he remarked that "the fear of monitoring these [social network] sites [because of requirements to report adverse events] is unfounded."

Hope I didn't misquote you John!

AdAge is Wrong! Drug Ads, Not Bad News, Cause Frayed Attention Disorder (FAD)

Here's something to think about.

According to Advertising Age, Americans Long for a Chance to Rest, Replenish and Reboot. We are, says AdAge, "Whipsawed by Stimuli" and "Our Attention Is Fraying and Disorders Are Multiplying."

I call it Frayed Attention Disorder (FAD).

What's the cause?

According the AdAge reporter, what's causing FAD in Americans is all the bad news about "Car bombs in Iraq. Car bombs in Afghanistan. Coordinated car bomb attacks in Pakistan. And then -- to vary the tempo -- a visit to the funeral of the victim of a car bombing (that gets car bombed)."

"I can't stand to read it," she admits.

That's too bad. BTW, did you vote for George Bush? I don't know about you, but I think of SAD (Stupid Attention Disorder) whenever I see Bush talk about Iraq and Iran and Afghanistan and Pakistan.

But it's not really that "People are tired of terrible" that causes FAD. AdAge should look closer to home for the cause: namely, all the ADVERTISING that we are bombarded with.

AdAge suggests that Americans want to take drugs whenever they read the Times or watch the TV news.

First of all, real Americans don't read the Times (or any other newspaper for that matter) or watch TV news (unless it's the local news and then only for the weather or traffic report).

When we do watch the news, we are bombarded mostly by drug ads, which are sometimes more disturbing than the news. Who wants to see those creepy, crawly ants up and down someone's legs when she is trying to relax and do the crossword puzzle (who does crossword puzzles anyway?).

Curiously, drugs may also offer the cure as well as the cause of FAD. I only hope that the drug industry pays attention to this silent epidemic that "touches upon" 40% of US adults!

RLS Foundation (aka GSK?) Calls for Boycott of Consumer Reports Over Ad Spoof

Consumer Reports -- published by Consumer Union -- recently launched its "Antidote to TV Drug Ads" series that intends to be "an entertaining new online video series that will track and report on such ads." Needless to say, the videos are YouTube-like spoofs.

First up in the series is a spoof of GSK's Requip TV ad (here).

CR doesn't say anything about this ad that I and other bloggers have not already said a long time ago (see, for example, "Restless Brush Syndrome: Lessons for Requip Marketers" and "Restless Pharma Marketing").

"Extremely Sarcastic and Insulting Video"
However, CR does have a HUGE readership that I can only dream of! As a result, its attack on Requip drew the attention of the Restless Leg Syndrome Foundation, the supposedly grassroots patient advocacy group with suspicious monetary and corporate ties to GlaxoSmithKline (GSK), the marketer of Requip (see posts cited above).

The RLS Foundation issued this clarion call to its "members":
"We wanted to apprise everyone on our mailing list of some bad press for RLS. We want to encourage you to 'fight back'.

"A video on consumerreports.org promises 'relief from restless legs hype.' The RLS Foundation is taking a tough stand against this type of bad press for RLS.

"Click here to watch this extremely sarcastic and insulting video for yourself. Then, click here to read the RLS Foundation's response to this video.

"The RLS Foundation is calling for drastic measures to respond to this video. We aren't concerned that they are reporting on a drug. We are concerned that they are mocking a condition that so many people live with everyday. We encourage you to respond to this advertisement immediately. If you are a subscriber of Consumer Reports, we encourage you to cancel your subscription...."
I am not going to deconstruct the RLS Foundation's letter to Consumer Reports except to mention that it compares RLS to childhood asthma (eliciting images in our minds of beloved, helpless, suffering children) and suggests that the side effects are worth it considering that RLS can be a cause of suicide!

Mirapex Buzz Marketing Response
A comment I received to a previous post indicates that the Mirapex buzz marketers will have a field day with this:
John -

Thank you for your article! I suffer from RLS -- sometimes it's really quite horrible. Just trust me on that. Anyway, I'm not writing about RLS, but about how grateful I am to learn more about who's behind the RLS Foundation.

A story for you: I just received an e-mail from the RLS Foundation criticizing and ad from Consumer Reports. Here's an excerpt...

[see above]

So, I showed this to my wife -- who's much brighter than I am -- and she said, "Hmmm. I don't see anything wrong with the Consumer Reports ad. And, hey, y'know the RLS response doesn't sound like a non-profit's response -- I didn't think that non-profits went around attacking each other for protecting consumers. I wonder if we could find out if RLS Foundation has any corporate sponsors..."

So, I Googled 'rls foundation sponsors requip' and found your article. When I read it to my wife, she did a little celebratory jig. ;-)

We were both delighted to find that you'd done some research and were able to help us learn that there IS a connection b/t the RLS Foundation and the RLS drug makers.

What to do next, I don't know -- my Mirapex is a real life-saver -- but I was certainly glad to learn about the connection.
Sorry, anonymous, "my Mirapex is a real life-saver," gave you away. But, thanks for thinking of me and telling me about the RLS Foundation's email and letter. BTW, for the record, I think the Mirapex promotional campaign has flaws, but at least I can't accuse it of disease mongering.

Tuesday, November 13, 2007

Accomplishing Adherence: Highlights from a Conference

Yesterday, I attended eyeforpharma's Patient Adherence and Persistence Summit and eCommunications/Online Marketing conferences in Philadelphia, PA. While there I met the usual suspects and reconnected with some old friends.

Shire, Shire, Shire
People from Shire -- specifically the Vyvanse (for children with ADHD) marketing folks -- were there in force making at least 3 presentations. Recall that Mike Boken, Senior Product Director at Shire, spoke about creating synergy between PR and marketing at a previous conference I attended (see "J&J Blog, Shire PR: The Whole Story and Nothing But the Whole Story!").

I think the Shire people are out there laying the groundwork for Vyvanse, the new formulation of Adderall, which has lost patent protection. The big news is that Vyvanse will likely be approved for use by adults soon. We can expect, therefore, some interesting DTC advertising and PR focused on adult overachievers!

But, right now, the Shire folks at these conferences are focusing on ADHD in children because that's all they can talk about. Obviously, however, all their marketing and PR is directed at adult caregivers -- it's not ethical to promote directly to children.

In this post I will summarize a couple of presentations that focused on adherence. Tomorrow I will report on the eCommunications conference.

Adherence in the ADHD Market
David Baker, VP & General Manager of Shire's ADHD Business Unit, presented on "Best Practices for Fostering Adherence." He used the ADHD market as a case study.

First, how do you define adherence and why is it so important to "foster" it?

Baker suggested this definition of Adherence:
Adherence = Fulfillment + Compliance + Persistence
where Fulfillment refers to the filling of the very first script for a medication, Compliance means taking the medication as prescribed by the physician, and Persistence refers to the length of time you take the medication.

Poor persistence is the main culprit. Lack of persistence is a big problem for the pharmaceutical industry. James Chase, my friend and editor-in-chief of MM&M, once wrote "To say that tackling patient compliance and persistence poses a challenge to the pharmaceutical industry is like calling Tiger Woods a competent golfer or describing Katrina as a particularly bad storm. It is a gross understatement." (See "The Pursuit of Persistence".)

Persistence with ADHD medication -- like most other drugs that do not have a noticeable, immediate effect on lifestyle like Viagra -- is poor. Baker showed a persistence graph for, I suppose, Adderall, over a 10-month period. Starting with 98% of patients taking the medication, it ended with only 13%. It looked like this:

The drug industry simply does not understand why patients stop taking their medications although there are many theories. What Baker suggested is that marketers must first do the research in their market to find out why their patients are not compliant or stop taking their medication.

The ADHD market has its own particular barriers to persistence, which baker described in detail. I won't get into that detail here, but will save it for publication in a future issue of Pharma Marketing News.

Regarding solving the problem, Baker described Shire's SHINE program for ADHD support. Some of the features of SHINE, according the Vyvanse web site, include:
  • Tips to improve focus, organization and behavior in your child
  • Suggestions for working with your child's teachers
  • Vyvanse Success Tracker
  • Ideas for building and coaching your child's support team
It also includes multiple mailings -- especially during the first few months of treatment -- timed to key dropoff points. These mailings are customized according to age of patient, whether the patient was switched from another medication or is new to ADHD treatment, etc.

Baker explained why Shire focused on the patient in its effort to improve adherence. It seems obvious -- the patient is the one that exhibits the behavior. However, some people also lay the blame on the physician. According to a study of patient behavior reported in the June 2006 issue of MM&M, seventy-two percent of all patients who stopped taking their drugs lack confidence in their healthcare provider.

But Shire also had these reasons for focusing on the patient:
  • better control of the message
  • consumers are more willing to listen to 3rd parties about ADHD treatment
Baker didn't get into the role of 3rd parties such as celebrities in adherence messaging (for more on that see this post), but he did point out that the more control you have over the message, the lower will be your credibility. This little tidbit should be advice to pharma marketers, especially when they dive into the Web 2.0 arena.

"Forget forgetfulness" as a factor in adherence was one of Baker's main take-away points. Reminder programs alone have very little impact on adherence. Also, although Shire based a lot of its persistence messaging strategy on patient interviews, Baker warned attendees not to rely solely on what patients say are their reasons for non-persistence or non-compliance.

Reward Them -- Intermittently -- and They Shall Adhere!
Murat Kalayoglu, Director at HealthHonors, talked about "Crafting an Rx Adherence Program with Dynamic Intermittent Rewards." He actually paid homage to B.F. Skinner, the psychologist who invented the "operant conditioning chamber," aka the Skinner Box.

The classic Skinner Box experiment uses a pigeon, which gets rewarded with a food pellet every time it pecks the desired key (see left).

I remember the "The Dancing Chicken" exhibit in New York's Chinatown. Whenever I took a date to dinner in Chinatown, I took her to see the "Dancing Chicken." Hey, don't knock it. It was usually the highlight of my evening!

The chicken would "dance" whenever you dropped a quarter into the slot. Afterward, the pellet!

Only now, after listening to Kalayoglu, do I realize that the best way to improve patient adherence is to consider them "dancing chickens." Reward them and they shall comply!
NOTE: Kalayoglu actually suggested that we think of patients as kids and described the "Great Marshmallow Paradox" to make his point. I can't get into that level of detail here. Read about it in a future issue of Pharma Marketing News. Subscribe NOW so you don't miss it!
HealthHonors encourages patients enrolled in its program to call an 800 number every time they take their medication and earn points, which can be traded in for real life healthy goodies like discounts at Boscov's or wherever.

But...DO NOT reward then every time or else they will think they are entitled to a reward no matter what. Reward them "intermittently." Kalayoglu had some data to back up his claim that intermittent rewards sustain target behavior over time whereas continuous rewards show a dropoff in target behavior. Perhaps more important is the fact that giving fewer awards is cheaper!

No dancee, no rewardee!
In any case, unless HealthHonors installed a Big Brother spy cam in the patient's medicine chest, how would they know that the patient actually swallowed the pill?

OK. Enough. Time to take a shower and get to work!

Saturday, November 10, 2007

AbelsonTaylor's "Your Bowel Movements Miss You" Campaign Pitch for Amitiza Fails to Move Takeda

AbselonTaylor (AT), the ad agency responsible for the innovative and multi-award winning "Your Dreams Miss You" Rozerem DTC campaign (see here, here, and here), failed to move Takeda with a similar advertising plan for Amitiza, the Japanese drug company's anti-constipation medication.

According to an inside source speaking anonymously to this reporter, AT's failed pitch revolved around the theme "Your Bowel Movement Misses You "Your Dreams Miss You" made famous by the ," which is reminiscent of the tag lineRozerem campaign that feature dream images of Abe Lincoln, a beaver, a deep sea diver, and a purple pony (not all in the same dream).

This reporter was able to obtain a copy of a print ad storyboard that AT presented during the ill-fated Amitiza pitch (see below).


The concept featured an image of a Bristol Type 2 "sausage" stool -- indicative of constipation -- with the head of a beaver and surrounded by a halo of Type 1 "hard nuts" stools -- also indicative of constipation. The beaver head delivers the strong message that you should talk to your doctor if your stool looks like him (or her; this reporter cannot ascertain the sex of the stool)!

[To learn more about the Bristol Stool Scale, see the Amitiza "Symptom Tracker" or read this wikipedia entry.]

"We're really disappointed that the Amitiza team could not get beyond the toilet jokes and see the potential of this campaign to capture viewers' attention and create buzz," lamented Dale Taylor, president of AT.

In the end, Takeda went with Publicis' Glow Worm to launch its Amitiza DTC campaign (see "Amitiza DTC seeks to move constipation sufferers").

Not only is Amitiza Takeda's #2 drug in terms of indication, it is #2 in terms of sales as well (IMS data not available; but you can look it up on Cafe Pharma if you don't believe this reporter.).

"We think the sales numbers speak volumes in support of our decision to go with Publicis' Glow Worm vs. AbelsonTaylor," noted Aimee Berner, marketing director, gastroenterology at Takeda, which co-markets the drug with Sucampo Pharmaceuticals. "We certainly didn't want another constipated -- ROI-wise -- campaign on our hands like the one for Rozerem."

"Our creative for the Amitiza campaign may not win us awards," said Amy GoodTurd, senior account rep for Glow Worm, "but it sure caused movement in the market!"

Friday, November 09, 2007

The Merck and Vioxx Show

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Also see:
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Also see:

Thursday, November 08, 2007

The Natrecor Waterboard Tortured Tchotchke

J&J's Scios unit was cited for "inappropriate reminder labeling" by the FDA for distributing a Natrecor heart failure drug computer mouse pad and pen to physicians.

As shown in the mouse pad photo on the left, the image "evokes the concept of a sedentary hospital patient drowning" according to the FDA untitled letter.

NOTE: It's not really a "warning letter" unless it is addressed to the company's CEO. This letter was addressed to Sunita Sethi, Director, Regulatory Affairs at Scios Inc.

According to FDA regulations, reminder labeling is labeling that calls attention to the name of the drug product, but does not include its indication or dosage recommendations or other representations or suggestions relating to the drug product.

"Reminder pieces," says the FDA, "may not include, among other things, representations or suggestions concerning effectiveness or patient population. Because this image makes these implications, the pieces cited above are not considered reminder labeling and appropriate indication and risk information need to be included. However, these pieces fail to include this information."

"Specifically," says the FDA, "the mouse pad and pen present an image of a distressed older male patient in a hospital bed. The patient is submerged up to his shoulders in water ...Simply put, the image evokes the concept of a sedentary hospital patient drowning."

Speaking of "reminders," all this language and imagery reminds me of waterboarding and the recent confirmation hearings for attorney general nominee Michael Mukasey, who has refused to categorically reject the practice as torture.

Imagine, if you will, Sunita Sethi testifying before some FDA panel about whether or not these Natrecor Tchotches were "inappropriate reminder labeling."

Meanwhile, note that the FDA DOES NOT request the removal of all errant tchotchkes from doctors' offices and gives Scios until November 21 to respond to the FDA's request to "cease the dissemination" of the mouse pads and pens. I am sure Scios reps will be working overtime between now and Thanksgiving -- giving away as many of these pads and pens as possible to thankful physicians, saving Scios enough dough to buy all their reps a holiday turkey.

Here's DDMAC's "request":
"DDMAC requests that Scios immediately cease the dissemination of violative promotional materials for Natrecor such as those described above. Please submit a written response to this letter on or before November 21,2007, stating whether you intend to comply with this request, listing all violative promotional materials for Natrecor such as those described above, and explaining your plan for discontinuing use of such materials."
Let's see, Scios has about two weeks to respond with a plan to stop the dissemination, not 2 weeks to actually STOP dissemination. Who knows what timeline the plan would have.

To bad the US FDA is not as powerful as the Chinese FDA (see "What the US FDA Could Learn from China's FDA").

Lily-White Lilly. Homophobic and Sexist Too?

According to a recent Indy Star story, "dozens of current and former workers at Eli Lilly and Co. are stepping forward to accuse the Indianapolis drug maker of racial discrimination, adding heft to an ongoing lawsuit that paints the company as hostile to black employees."

Another recent AP story noted that the NAACP "joined an expanded racial discrimination case in which more than 50 plaintiffs now allege Eli Lilly & Co. created a hostile workplace and paid them less than their white peers."

The story went on to mention that Lilly's highest ranking black employee is Derica Rice, the company's chief financial officer and a senior vice president.

Perhaps its highest ranking Puerto Rican employee is Dierdre Connelly, president of U.S. Operations. NOTE: Where I come from -- NYC -- Puerto Ricans/latinos were and maybe still are considered a "race" to be discriminated against as viciously as blacks.

After Connelly made a few remarks -- which some call courageous and others call outrageous -- at an industry meeting on Monday, she was criticized for:
  • being "Far removed from reality" (see this post at World of DTC Marketing)
  • accusing sales reps complaining on Cafe Pharma of being cowards
  • masquerading as a sales rep
  • speaking out instead of staying home and minding her business
Comments on pharma blogs & boards seem to follow a similar pattern:
"Deirdre Connelly is out of touch. Seriously, Lilly is in deep shit with her in charge." (heard at PharmaGossip)

"Dierdre is a legend in her own mind and has no idea what we do anymore." (heard at Pharma Marketing Blog).

"Connelly is nothing more than a witch without a broom." (heard at Cafe Pharma)

"DC was a rep in Puerto Rico, where virtually everything is under the Reforma program; she "promoted" Illosone & Keflex -- and in those days a female rep in a chauvanistic (sic) culture like Puerto Rico -- come on now." (heard at Cafe Pharma)
BTW, is there a male equivalent of "witch without a broom?" How about "Jock without a Strap?"

Pharmaceutical Diversity -- An Oxymoron?
Which finally brings me to a continuation of my post yesterday about the "diversity issue" at Lilly and other pharmaceutical companies, especially in the executive suite.

Although Lilly has said that 16 percent of its employees are minorities, the Indy Star article notes that some outsiders say Lilly and the drug industry as a whole is vulnerable to racial charges because relatively few senior executives are minority.

"From what we can tell, the senior management ranks of major pharmaceutical companies are not particularly diverse, which makes them incrementally more of a target of discrimination suits," Les Funtleyder, a drug analyst at Miller Tabak & Co., wrote in a research note to clients.

If you are a "person of color" working within the drug industry and have any personal stories related to diversity in your work place, I'd like to hear from you.

Wednesday, November 07, 2007

What the US FDA Could Learn from China's FDA

Chinese drug regulators threatened Wednesday to pull the licenses of 16 pharmaceutical companies that allegedly ran advertisements exaggerating the benefits of their products, reports AP (see "China's FDA Cracks Down on Misleading Drug Ads").

The State Food and Drug Administration said the ads contained "a large amount of unscientific assertion and pledges on the products' benefits and effects," the official Xinhua News Agency reported.

Local branches of China's FDA were to ensure the companies remove the offending ads (my emphasis).

First of all, I didn't even know China ALLOWED advertising of drugs -- I guess this refers to ads for health professionals.

Wow! When was the last time you heard the FDA threaten to revoke a drug company's license to market a product if it did not remove offending ads?

It appears that the Chinese FDA is ordering the "removal" of ads currently running.

Even if the US FDA did issue such threats, they would be empty threats, since it acts only well after the barn door has closed (see "Another Award for Rozerem! This one...not so good.").

I agree with a comment made on this issue over at Pharmalot:
"I recommend that the Chinese FDA take over for the US FDA and pharmaceutical industry…..minus the Communism….:-)"
Of course, that won't happen. But the Chinese are having an effect on the FDA.

Just recently, the President's Interagency Working Group on Import Safety recommended that the FDA be given power to recall toothpaste and pet food if they pose a safety concern to Americans and their pets (read the Prez' speech here).

No mention, however, was made of giving the FDA more power to recall drugs. That slack may be taken up by Congress. Reps. Henry Waxman, D-Calif., and Tom Allen, D-Maine, and Senator Ted Kennedy, D-Mass. introduced a bill that would give FDA power to essentially "de-license" OTC drugs (see "Increased FDA Authority Over OTCs Sought in Waxman Bill").

Lilly's Connelly: The Diversity Issue

Some heat in the Pharma BlogosphereTM is being generated by Dierdre Connelly's keynote presentation at the recent Marketing & Sales Summit hosted by Pharmaceutical Executive Magazine. Mostly the "news" is about her dissing reps that speak out on Cafe Pharma.

It started with the article "Lilly's Connelly blasts reps mouthing off online" posted by MM&M's Editor-in-Chief James Chase, in which Chase quoted Connelly:
"Lilly USA president Deirdre Connelly yesterday took a swipe at online forums that attract disgruntled, venting sales reps, describing sites like CafePharma.com as 'outlets for people who don't have the courage to speak out with their ideas' for improving their roles and the performance of their companies."
Ed Silverman at Pharmalot also pointed out that a doc once belittled Connelly once when she was pretending to be a sales rep:
"When Connelly told the doc she didn’t have samples but just wanted to talk for a minute, he stepped back, seemingly offended, and asked her why she was there and where was his regular rep? Eventually, he asked to see Connelly's business card. 'President, Lilly USA,' he read. 'President? President of what?'" (See "Lilly’s Courageous Connelly: President Of What?")
I was present at Connelly's presentation.

Pat Clinton, Editor-in-Chief of Pharmaceutical Executive Magazine, read Connelly's resume when he introduced her -- it was quite chock-full of promotions up the corporate ladder, starting off as a sales rep. Connelly grew up in Peurto Rico and, according to her, was overwhelmed when she was first hired. Her family and friends were proud of her then and probably even more so now. I wanted to hear more about her life and how she made it to the top -- more in her own words telling her personal story. Unfortunately, I didn't ask her when I had the chance!

I think more pharmaceutical employees and executives need to tell their stories in their own words and have urged pharma companies with corporate blogs to allow that to happen (see "A Primer on Pharma Employee Blogging").

But Connelly's story must also be viewed through the lens of some of those cowardly Cafe Pharma denizens who are now engaged in a discussion of the merits of diversity at Lilly. The thread is entitled: "Diversity is killing Lilly." It's a very popular and heated discussion with over 6,600 views since it began back in May, 2007, with this comment:
"As a long term employee, it absolutely kills me to see what diversity has done to Lilly. Over the last 10 years or so, the increase in diversity (read blacks and females - not thought) has been inversely proportional to the effectiveness of the company. It looks like it will only get worse with the quotas we have at every level of the company."
Connelly may have benefited from this program, I dunno. But instead of dissing reps who post problems on Cafe Pharma, Connelly should study the criticisms and use her own story to counteract them. In her keynote speech, however, she said she used to look at Cafe Pharma but stopped doing that when she became president (of whatever).

That's too bad. Connelly can learn more from "disgruntled employees" (who may typify Andy Grove's "Wild Ducks") than from underlings who glad hand her whenever she asks how things are going.

If Ms. Connelly reads this, I hope she
  1. tells her personal story in her own words (not the dry facts, which anyone can find on Wikipedia here, but how she overcame obstacles to get where she is and what motivated her to do it), and

  2. reads the following comments from anonymous Cafe Pharma cowards:
Who in the hell is she trying to fool? If she was indeed ever a rep, what planet or at least what era was it in?

THE SQUEAKY WHEEL GETS FIRED! THIS IS WHAT WE CALL REALITY. DON'T TRY TO MAKE US LOOK BAD IN A NATIONAL FORUM WHEN WE HAVE THIS AS OUR ONLY FORUM TO COMPLAIN!

If a rep did indeed complain about something in this company that was clearly broken, like reach and frequency expected above all else, you would run them out of here ASAP! Everyone knows this, especially INDY, so if we don't get s spot on the podium at a national meeting, don't expect us to quit venting here!

ps,
I am not holding my breath waiting on her reply

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At least she was indeed a rep. The industry has changed a bit since she was in the field every day. Pissing off a doc every-once-in-a-while doesn't qualify as keeping a finger on the state of the field reps!

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Being a rep in 2007 is a little different than being a rep in 1983. I have been both, she hasn't!

My requirements back then carrying everything that the company made were: GET THE BUSINESS. That history is just that, HISTORY!

Do you agree Diedre?
And what about that "diversity issue" at Lilly?

Andy Grove Calls for Pharma "Wild Ducks." Quack! Quack!


What stands in the way of more and faster success in getting cures to patients?

Newsweek posed this question to Andy Grove, former CEO of Intel, in a recent interview ("A Research Revolution"). You would think such a smart guy would come up with an enlightening and actionable answer. Instead, he came up with this:
"The peer review system in grant making and in academic advancement has the major disadvantage of creating conformity of thoughts and values. It's a modern equivalent of a Middle Ages guild, where you have to sing a particular way to get grants, promotions and tenure. The pressure to conform [to prevailing ideas of what causes diseases and how best to find treatments for them] means you lose the people who want to get up and go in a different direction. There is no place for the wild ducks. The result is more sameness and less innovation. What we need is a cultural revolution in the research community, academic and non-academic. We need to give wild ducks the opportunity to emerge and quack their way to success. But cultural change can be driven only by action at the top."
Wild Ducks May Also Be Quacks!
There's a lot here to criticize. Grove, like many patients, is pissed off that there isn't a cure for cancer -- prostate cancer in his case. By grants, I suppose he means drug industry grants supplied to patient groups to disperse to any of the quacking "wild duck" physicians/institutions that patient organizations deem worthy. He could also be talking about academic research sponsored by pharmaceutical companies.

Grove wants faster results and irresponsible promises from the dug industry to deliver results:
"...you never hear an executive from a pharmaceutical company say, "Before the end of the year I'm going to have xyz drug," the way Steve Jobs said the iPhone would be out on schedule. The heart of every high-tech executive has been, get the product into customers' hands and ramp up production. That drive is just not present in pharma; the drive to get sufficient understanding and go for it is missing."
I think most people in the dug industry -- especially those on the research side -- would beg to differ. Also, Grove's "sufficient understanding" is a recipe for disaster in the pharmaceutical industry. Medical science is not as exact as the physics underlying computer chip development. There have been plenty of times where the drug industry has pushed through drugs to market with only a "sufficient understanding" of the risks, for example. A case in point would be Vioxx.

And when a drug that is pushed too quickly to market without more than a "sufficient understanding" of that market -- ie, Pfizer's Exubera -- the cost can be very high ($2.8 billion in Exubera's case).

I sought of agree with Grove when I read between the lines -- if by "wild ducks" he means giving more power to younger researchers who are not set in their careers and who are willing to risk not the lives of patients but their jobs on pursuing their "quacky ways." And this won't happen unless there is cultural change at the top of pharmaceutical companies -- especially getting rid of lawyers in those positions.