Tuesday, February 28, 2006

Off-label Marketing: Next State Issue

California leads the way in many things, including laws to reign in pharmaceutical marketing and sales. Where California leads, many other states follow. The latest proposed California law is Assembly Bill 2856, introduced February 24 by State Assemblywoman Loni Hancock (D.-Berkeley). More on that below.

Gifts to Physicians
Another recent law enacted in California in 2005 (the California Health & Safety Code 119400-119402) requires pharmaceutical companies to declare a limit on the amount of money they spend on "gifts" per physician in California. This subject is discussed by experts and survey respondents in the latest issue of Pharma Marketing News (see "Free Gifts to Physicians: What's the Big Deal" in the February 2006 Issue).

According to the February 17, 2006, Daily Health Policy Report published by Kaisernetwork.org, "at least nine states are considering bills that would require pharmaceutical companies to publicly report annual gifts to physicians, hospitals and pharmacists..."

[Actually, Vermont, was ahead of California with a 2002 law that requires drugmakers to report to the state's attorney general all gifts of $25 or more given to doctors, hospitals or pharmacists. (see "What Pharma Companies Spend on Gifts to Docs"). It may just prove my point: States like Vermont are vying to beat California, which is still seen as the leader in the fight against big pharma.]

Thanks to these laws, the industry is forced to be a bit more transparent about where its marketing dollars are spent (see table below). Massachusetts state Sen. Mark Montigny (D), sponsor of a Massachusetts bill patterned after the Vermont law , said, "If a doctor needs a Caribbean vacation or a mug or a pen, he or she is probably not very successful and needs to be in another business." Montigny added, "The No. 1 thing that keeps government and corporate officials honest is transparency."

Pharma Spending on Gifts to Docs

I agree with the need for transparency to keep people honest (see "New Year's Resolutions for Pharma"), but I prefer that companies do this on their own rather than it being legislated. Unfortunately, it takes a crisis to get pharma companies to adopt voluntary guidelines. By then it is often too late to stop the wheels of government regulation.

AB 2856: Off-label Practices Attacked
AB 2856, aka, Prescription Medication Off-Label Use Informed Consent, would require physicians and surgeons (not dentists?) to obtain informed consent from patients before prescribing, administering, or furnishing prescription medications for off-label uses. It defines off-label as: "prescribing, administering, or furnishing a prescription medication to treat a condition that is not within the indications for that medication approved by the federal Food and Drug Administration."

"Before prescribing, administering, or furnishing a prescription medication for an off-label use," says AB 2856, "a physician and surgeon shall obtain informed consent from the patient. For these purposes, the physician and surgeon shall inform the patient verbally, in easily understood terms, of all of the following information:
  1. The medication is furnished to treat a condition that is not within the indications approved for that medication by the federal Food and Drug Administration.
  2. The nature, degree, duration, and probability of the side effects and the significant risks of the medication that are commonly known by the medical profession, including the medication's adjuvants, and the degree to which the side effects of the medication may be controlled.
  3. A division of opinion exists as to the efficacy of the use of the medication.
  4. A description of the effect of the medication on the human body.
  5. The dosage deemed medically necessary to treat the patient's condition.
  6. The median age group for which the medication is prescribed.
  7. Available and appropriate medical alternatives to the medication and the reasons the physician and surgeon recommends the medication instead."
This is quite a laundry list! In this day and age when pharma companies are emphasizing that all drugs have risks and that it is up the informed patient to evaluate drug risks vs, benefits, the above procedure should be applied to ALL drugs, in- or 0ff-label.
"Armed with the knowledge that a prescription was off label, proponents say, patients might ask more questions; seek other sources of information, such as the Web; watch more closely for side effects; or ask for an approved treatment instead."
But will physicians comply if the law was passed?
"But doctors say such a disclosure would only scare patients, possibly spurring them to refuse a medicine they sorely need." San Francisco Chronicle: Hard Sell: How Marketing Drives the Pharmaceutical Industry" (May 2005).
You can expect both physicians and the pharmaceutical industry to weigh in on the merits of this bill now that they can see the language.

Friday, February 24, 2006

GSK's "Plain Talk" Flawed

This discussion starts with the post I made a few days ago about GlaxoSmithKline (GSK) using sales reps to spread the word about the value of brand drugs (see "Sales Reps Make Poor Spokespeople").

The use of sales reps is only part of GSK's multi-faceted campaign entitled "Plain Talk." Drug reps are most probably focusing their efforts on their doctor clients (see Sam Nalbone's comments quoted yesterday in "
Pharma PR: It's All About Defending Drug Prices".
Whole Story
Another facet of this campaign, however, is focused on consumers and can be found at the WebMD mini-site called "
The Center For Plain Talk About Medicines In America" that GSK is sponsoring (the image on the left is used to advertise the Center on other Web sites; compliments of adverlicio.us).

GSK makes the argument (among others) that improved healthcare in America -- due mostly to prescription medicines and measured by life expectancy -- would be endangered if price controls such as those used in countries like Canada were adopted here in the US. This argument is presented in the section "Why Do Medicines Seem So Expensive?"

1. Medicines help Americans live longer
(GSK claims)

"Here's something else you should know," says GSK, "Advances in medicines -- including antibiotics and medicines to treat and prevent heart disease -- have helped increase the average lifespan of a person born in the US to close to 80 years."

In fact, life expectancy (LE) -- as shown in the chart below the above statement on the WebMD site -- for the US is 77.4 years; close to 80,
but no cigar. It's actually closer to 75 than 80. I'm not a fan of rounding up to improve your argument, but OK, let's not quibble. It's good that life expectancy is rising in the US.

2. Price Controls are not necessary
(GSK claims)

"Because America is the world's prescription medicine research and development (R&D) powerhouse, most new and breakthrough medicines originate here and become available to American consumers faster and more readily than in countries like
Canada, [my emphasis] which have price controls. These countries have made a choice to limit the availability of medicines (and healthcare generally) to control costs."

Here's how I read the message: If the US were to limit prices and control costs like Canada, US citizens' health will suffer.

3. But using GSK's own indicator of health (ie, life expectancy), Canada (as well as many other
countries that control costs), is better off than the US:

According to
CIA World Factbook (can't get much more "fact-founded" than that unless you buyin to the Bush administration's notion that the CIA is a bunch of jerks who can't get their facts straight), the life expectancy at birth for Canadians is 80.1 years (2005 est.), which is REALLY close to 80 and even better! The U.S., which ranks 48 out of 226 in the CIA list, has an LE of 77.1 years, which is close to what GSK says. BTW, Canada ranks 12th.
"The life expectancy in the US is brought down by our high infant mortality rate and similar factors. I hypothesize that upper middle class Caucasian men and women of Northern and Western European ancestry live quite long in the US." -- Kathy O'Neill
Bosnia and Herzegovina, which has an infant mortality rate of 21.05 deaths/100 live births (compared to the US's 6.5/1000) has an LE of 77.83 years, about 0.73 years more than the US (about the extra life cancer patients might get from Avastin).

Whatever the case, all this discussion, which focuses a lot of criticism (as well as praise) on GSK's "go-it-alone" PR campaign, is an example of why this kind of PR task should, according to some people, be left to PhRMA.

"Clarence," GSK's R&D Guy, Trumps "Jamie," Pfizer Viagra Guy!
I much prefer GSK's TV ads that feature research scientists speaking about how difficult it is to develop new drugs. Last night, I saw a new version of this ad in which the on-screen personality introduces himself as "Clarence." This is the kind of personalization of the message that I have recommended all along (see, for example, "
Blogs and the Pharmaceutical Industry").

I can't wait to learn more about Clarence and what he does at GSK! But I would not be interested in hearing from "Jamie," the sales rep dude, discussing how difficult it is to convince docs how cheap drugs really are!

Thursday, February 23, 2006

Pharma PR: It's All About Defending Drug Prices

A couple of days ago, I posted a note about pharma sales reps being poor spokespeople for the industry (see "Sales Reps Make Poor Spokespeople"). This topic generated -- and continues to generate -- a lot of discussion on the Pharma Marketing Online Discussion Forum.

At first the discussion stuck to the topic of whether or not sales reps make good spokespeople for pharma. Leo Doran, for example, went one step further than I did and said that using sales reps as PR people was "dangerous":

"Employees and Sales people can be good Ambassadors for a company, but it is dangerous to allow them to be spokesman for the company. Any successful PR program has at its roots a consistent message and script.

To empower 8,000 sales people with the role of PR spokesperson gives the media an open season for comment from all about management's decisions and path. I hope GSK is leaning more to community relations for these people as part of their job description." -- Leo Doran
Harry Sweeney hoped that reps, whether appropriate for the job or not, would be heard:
John: Please don't "despair." Using sales reps -- the most "local" members of the pharmaceutical industry -- may be the best, if not the only way to deal at the grassroots level with the other "local" actors in the healthcare equation -- elected officials, physicians, pharmacists, hospitals, etc. etc. -- who have had a field day stirring up anti-industry sentiments.

Localization and personalization have been two mighty rhetorical, political tools, used effectively by industry critics, yet to date, largely ignored by the industry itself.

One reason it's so easy to beat up on the Pharma industry with impunity is because it can easily be characterized as a heartless, faceless, big business, that resides "somewhere else." e.g. Know any big time Pharma influences in Senator Grassley's home state -- Iowa?

The 80 to 90,000 "local" representatives who are, at the local level, "one of us," however, changes all that. These are people like you and me, who have every right to speak up and out about healthcare financing reform issues which are a root cause of industry demonization.

Whether they are scripted or not, whatever they say will be subject to the kind of intense scrutiny and criticism that we've come to expect from industry critics. Hopefully, the criticism will be fact-founded and constructive. But, I wouldn't hold my breath waiting on that score.

In the meantime, don't despair. Rather take heart that legitimate industry criticism is being heard and steps are being taken, both to rectify industry past sins and to rebut unfounded criticism at the grassroots level. There's a long road ahead for the industry to regain the moral high ground. But, maybe we're witnessing the first step from Glaxo Smith Kline. I hope so.
But Harry brings up a good point: criticism should be "fact-founded." Let's see how that plays out in the discussion which follows.

Terry Nugent focused in more on the message rather the messenger:

I just attended a meeting of the Midwest Healthcare Marketing Association (MHMA) at which Mike Pucci, VP of External Relations at Glaxo, spoke. The program is indeed intended to reach out to the community at large. This can be as limited as reps' friends and families or as aggressive as making presentations to seniors groups. Glaxo is training its reps to be able to communicate the value of pharmaceuticals, an important message for professionals and the public. They are also running television ads that endeavor to communicate the same message.

Mike does an excellent job of communicating the value of medicines, nicely countering objections to cost. According to him, the latest Harris poll shows the image of the industry is improving after a long slide.

I think Glaxo is doing a great job. I only wish the companies would work together through PhRMA or some other umbrella to improve the industry's image. As Glaxo has realized, industry bashing by politicians is driven by negative public opinion. If the industry is to avoid onerous public policies such as price controls, it must improve the public's economic literacy, making it harder for government to kill the goose that laid the golden egg.
Notice that Terry brought up the issue of drug prices. Sam Nalbone followed Terry's lead a and brought a few facts into the discussion:
We should note that with all the focus on drug costs, they account for only 12% of health care expenditures. This kind of information floats out to the public but doesn't register until the drug rep makes the point in response to the doctor's articulated perception that drug prices are out of line.

The sales people serve a crucial role in receiving that communication from doctors so that they may respond knowledgeably. If they were not in front of the docs to hear that complaint, there would be no rebuttal to the doctors recitation of "conventional wisdom." They are therefore visiting doctors first as "Listenpeople" and responding as "Spokespeople." Like most of us, doctors hear better after they've spoken, and we can't hear anyone at all when they're speaking about a subject that isn't on our minds at that moment.
Katherine A. O'Neill backed Sam up on this:
Sam - you are absolutely right. Why doesn't PhRMA publicize the 12%? I have never understood that. I got into a heated discussion with an oncologist at a cocktail party about this. She did not believe that drug costs were so low.
[Must have been one of those pharma-sponsored "educational" cocktail parties.]

As you see, the discussion quickly turned to the real issue at the root of all industry criticism: the price of drugs. To improve the industry's image, either you lower the price of drugs (or keep the increase in line with the consumer price index as Roy Vagelos, former CEO of Merck did -- see below) or you defend price increases. The industry, of course, is doing the latter and Glaxo's program is all about defending the price of drugs, not about defending the industry per se.

But what are people really thinking about when they think about drug prices? I Googled some facts of my own and found evidence that the actual percentage number may be irrelevant and maybe it's the increase in that number recently that has people worried:

In 1994 the % was 5.6%; in 2001 it was 10%; in 2005/6 it's 12%. Seems to be accelerating.

A Kaiser report: Trends and Indicators in the Changing Health Care Marketplace said: "While remaining the largest contributor to spending on health services overall, the proportion of national health expenditures devoted to hospital care declined from 34.1% in 1994 to 30.4% in 2004. In the same period, the share spent on prescription drugs almost doubled from 5.6% to 10.0% of health spending in the U.S."

Where will it be in 2010?

The perception, if not the fact is that drug costs are increasing faster than other HC costs -- some of which are Decreasing. To get the whole under control, we must also get the parts under control.

Another interesting report I came across was a Harris Interactive survey that revealed that "rate of increase in out-of-pocket spending" is more important to people than the absolute amount.

That report also revealed that people believe drugs and medical care are more expensive here than in Europe (as opposed to gasoline) and that pisses us off. Especially since it is true.
OK. There's some "fact founded" criticism for you! As often happens, in the midst of this discussion new facts suddenly arose. I added these facts to the fire:
U.S. spending on prescription drugs will climb to $446 billion by 2015, up from $188 billion in 2004, according to a forecast by the Centers for Medicare & Medicaid Services. The annual spending rise for drugs now is projected to be around 8.2%, however, lower than earlier estimates (9.1%) due to the new Medicare drug benefit program.

National health care spending will grow by an average 7.2 percent annually over the coming decade, the study said. That would be slower than in recent years but still 2.1 percent faster than GDP growth, it said. (Washington Post story)

Back in 1990, when Roy Vagelos was CEO of Merck, he suggested to only increase prices at the rate of the Consumer Price Index (CPI). There was a "fair amount of grumbling," but Merck did it and was successful because it was a market leader and other companies followed. "Unfortunately," said Vagelos, "that has changed. Drug prices are increasing twice as fast as the CPI and that is going to be very damaging ultimately." (Vagelos Speaks, Will Pharma Listen?)
Derek Stilwell had another take on the "it's all relative" argument:
I agree with the need to look at prices in context, but to be fair, the context can and should be broader, or at least looked at from a number of different perspectives.

"Health care expenditures" is a huge category that can be defined in a number of ways. The patient's perspective being one of them. If I am not mistaken, that figure is a nationwide number that includes "everything". This 12% may not seem like a problem for those who are insured and have copays of 0 to 25 dollars for either the visit or the medication. But if an uninsured (or underinsured) patient pays $250 for a Dr's visit and $600 for the medications the Dr. prescribes (and this happens every month) the value perception may become skewed in the patient's mind. Ask the patient again how he/she feels about the Dr's fee when the renewals run out and it costs $250 just to have the prescription renewed. I think the answer may be somewhat different.

I think doctors are echo-ing the complaints of patients, who frequently ask if other lower priced alternatives may be just as good. And because doctors develop confidence in certain medications and combinations, and wish to see the best results possible, they use the most/best/newest alternatives available.

I think a better reply for a Dr's query would be to ask him how that 12% looks when compared to his administrative overhead, or even just billing and late/unpaid receivables costs. This is another proof of relativity that everyone will understand.
We'll pick up the rest of the discussion tomorrow.

Tuesday, February 21, 2006

Sales Reps Make Poor Spokespeople

I read with despair the article in today's AdAge about Glaxo's strategy to use its sales force as a "PR Machine" ("GLAXO DRAFTS EMPLOYEES TO POLISH INDUSTRY IMAGE: New Strategy Makes Entire Sales Force a National PR Machine").
"Deciding to eschew a traditional corporate branding campaign, Mr. Pucci [Michael Pucci, GSK'’s VP-external advocacy] instead has unofficially 'deputized' his sales force to speak on behalf of GSK and the industry about the affordability of prescription medication; how today's medicines fund the next generation of blockbuster drugs; access to state and federal programs that offset drug prices; and even some common misconceptions about direct-to-consumer advertising."
I have written about Pucci's efforts previously (see "The Empire Strikes Back" and "GSK Strikes Back with a Grassroots Campaign") and I even praised the strategy.

However, I did not pay enough attention to what appears to be Pucci's key tactic: using the 8,000-member GSK sales force to carpet bomb "every county in every state in the country."

I have very little faith in the ability (or even the desire) of sales reps to become
credible spokespeople, especially after reading "Hard Sell" (see "Generation X Pharma Reps").

Sales reps, however, are plentiful and are perfect agents for spewing forth the party line equipped with "aids" and canned presentations, which I am sure is what Pucci is arming them with.
But credible they are not!
I imagine an encounter between a Gen-X sales rep and a Rotarian member after the Powerpoint presentation: "Dude, what will it take to get you to love my company?" Sales reps just have to close the deal!
And credibility is the whole enchilada! Why send out the LEAST credible employees to do PR? Come on, Pucci! Get with it!

Pucci and GSK (and other pharma companies for that matter) need to broaden their horizons and enlist
MORE CREDIBLE employees to carry the PR load. I said this before -- use your rank-and-file employees (secretaries, researchers, etc.) to tell their OWN stories not "salient talking points and answers to tough questions," which are the features of a typical detail!

Also, get with the 21st century version of buzz! Forget the "Rotarians, Elks, Lions Club members, and senior-citizen groups" -- they cannot create buzz. Try blogs, podcasts, etc. If you need help with this, I'm sure there are dozens of people -- including myself! -- who can help you. But, really, get help.

Thursday, February 16, 2006

Avastin - Supersize Profiteering!

Speaking of the high cost of drugs, how about Genentech selling Avastin -- a drug used to treat colon cancer and now approved for the adjuvant treatment of lung and breast cancer -- for $100,000 per year per patient? Avastin is already a "blockbuster" drug with sales over $1 Billion per year (at $100,000 you only need 10,000 patients on the drug to reach that gold standard of drug sales).

This was brought to my attention by Katherine A. O'Neill, Ph.D., member of the PHARMA-MKTING online discussion group, who posted this comment today:

I have spent a lot of time defending the ethics of my industry - the pharma industry. But when I read the front page of the NY Times this morning, I felt sick. $100,000 per year for Avastin for colon cancer. It is unconscionable. When pharmaceutical companies do this kind of thing, they are ASKING for government imposed price controls. Genentech has no ethics. Even if, as they claim in the article, the 'economics' hold up, there is no justification for this kind of price. Shame on Genentech for being greedy. Double shame for holding patients with life-threatening diseases hostage.
Supersizing Profits
It seems that Genentech is copying the fast food industry's ploy of "supersizing" servings in order to maximize profits. That practice was exposed in the film "Super Size Me" in which Morgan Spurlock -- the movie's director, writer, and principal actor (I loved his doc: "You're going to die!") -- only ate fast food products for one month and, if asked by the teenager manning the order window if he wanted to "supersize that order", he always said "yes!"

Genentech has been selling one year's worth of Avastin to treat colon cancer for $50,000. The "supersized "dose for lung and breast cancer is two times the colon dose -- costing, if my math is right, $100,000 per year. Just like the extra fries and Coke, the cost to produce the additional dose of Avastin is "minimal" according to the article on this subject in yesterday's NY Times (see "
A Cancer Drug Shows Promise, at a Price That Many Can't Pay").

It's the Value Stupid!

The industry once defended high drug prices as the only way it could recoup the cost of research and development. However, that has been pooh-poohed by critics and at least a few past and current drug company CEOs have backed away from that defense (see "
Vagelos Speaks. Will Pharma Listen?" and "McKinnell's Mea Non Culpa"). [Tom McKillop, former CEO of AstraZeneca, however, insists that the industry needs to talk more about its R&D efforts, not less (see "Pharma's Jekyll & Hyde").]

Another pharma CEO had this to say: "As we look at Avastin and Herceptin pricing, right now the health economics hold up, and therefore I don't see any reason to be touching them," said William M. Burns, the chief executive of Roche's pharmaceutical division and a member of Genentech's board. "The pressure on society to use strong and good products is there." [NY Times]

"Health economics" is what he said. In other words, how much value do we place on prolonging the life of a patient by a few months? That's a hard argument to go against -- you would be better off advocating drowning puppies than to suggest that a few months of extra life is not worth $50,000 to $100,000 (or $10,000 to $30,000 in copays).

Speaking on the drug value issue,
Roy Vagelos, former CEO of Merck, had this to say: "Most drugs on the market have tremendous value and are priced right. We have outliers, however, that are going to kill us," warned Vagelos. He mentioned cancer drugs that are sold for $50,000 that deliver only 4 months of added lifespan on average. "I think that is very damaging," Vagelos said, "and does not follow the value line."

This topic will generate a long discussion thread on PHARMA-MKTING. Already, as I write this, responses to Katherine's initial post are coming in. Here's one from Sameer (these are professional marketing people, not namby-pamby consumer advocates with axes to grind):

Where is the rationale for this pricing?? I can understand that one may ask for a higher pricing for a biological with 100s of excuses related to its manufacturing and cost of raw material. BUT when the drug is a "small molecule" and chemically synthesized, its cost of development and trials are almost the same as any other product. Taking this logic into account, why on earth one takes the advantage of a dying person?? Just because the drug will give another 5-6 months of life and the person/family do not have any other way but to pay for any crazy amount fixed by some greedy bunch, to make someone live for another 5-6 months??

I strongly feel that there has to be some rationale (rather sanity) for the pricing of drugs and governments should interfere/protest/force the companies to stop their monopoly and greedy attitude, maintaining the ethics of this noble industry. I won't be surprised when people will start calling pharma people as a bunch of greedy robbers!! Not only robbing money but also robbing humanity and happiness.
Supersize for the Wealthy
I'd like to close with this thought -- I contend that Genentech and other pharma companies are moving to develop products only the "well off" (successful Gen Xer's no doubt) can afford (and there are quite a few of those people to cater to). Even with a good drug coverage plan, it would cost patients tens of thousands of dollars out of their own pockets (or "Consumer Directed Health Plans" in the future) to pay for these drugs.

Genentech only needs 70,000 Avastin patients to meet Wall Street projections of $7 Billion per year in sales for Avastin. Meanwhile, as the Times article points out, many other people are not able to pay. Considering that there is a potential market of hundreds of thousands of patients that could use Avastin, I just don't get the "health freakonomics" that justifies the price of $100,000.

Wednesday, February 15, 2006

FDA Backs Down on Coupon Study

According to Brandweek ("Advertising: FDA Floats, Then Sinks, Drug Ad Coupon Study" - subscription required), FDA "yanked" its Federal Register notice to conduct studies on the effect of coupons in print drug ads on February 9 -- one day after I commented on this study (see "FDA, Coupons, and Sleep Aid DTC Ads").

I don't know how you "yank" notices from a public record, but Brandweek quoted Crystal Rice, an FDA representative as saying: "The agency withdrew the notice because the matter required additional internal consideration."

There was no further comment from the FDA, nor do I find any entry in the Federal Register about "yanking" the previous notice. [I only assume there has to be another notice if just to prevent people from wasting their time commenting on the first notice!] You can still find the original notice in the FR, but if you can't,
click here. (There are some interesting studies cited there for those of you wishing to do some research on this topic).

In my previous post I basically accused the FDA of using the study design to engineer a "pre-emptive strike" on sleep aid drug advertising practices. As reported by Brandweek: "The focus on sleep aids appears to be a reaction to a run-up in activity in that category, some of which has been unusually bold. For instance, Ambien CR was launched with ads that screamed 'Free Ambien CR,' and had tear-off strip coupons like those on neighborhood handbills stuck to lampposts by people advertising rooms for rent."

Smoking Coupon Path

Other experts thought the FDA was heading down a broader, more ominous path. Harry Sweeney, member of the
PHARMA-MKTING online discussion group and Pharma Marketing Roundtable, for example, was quite outspoken about how the FDA would be going too far and his comments exemplifies what most industry people are thinking:
FDA better be careful going down the "smoking coupon" path to misleading consumers or they'll find themselves being forced to conform to the more commonly accepted FTC burden of proof which requires the agency not only to assert that something is "misleading" (what FDA has been getting away with for years) but requires proof in a court of law that consumers actually have been misled. That would be quite a comeuppance for FDA.

Our government is caught up in its shorts right now over the whole cost of drugs issue and its anti-industry bias is showing.

When the HHS-OIG writes an opinion criminalizing charity (i.e. industry-sponsored indigent patient programs), and bureaucrats attack industry plans to help patients cover the "donut hole" in Medicare Part D by threatening to use "anti-kickback" statues against companies participating in donut-hole discount programs, you know we're entering another Alice-in-Wonderland period. FDA's participation in this farce is lamentable. They're a better agency than that.
Well, Harry, you'll be happy to know that the agency has backed down -- it seems. I called the FDA and despite of -- or because of -- mentioning the dreaded "blog" word, I was unable to tease any more information out of FDA "spokespeople," who obviously were not willing to do any "spoking" on this subject. They did offer, however, to get back to me if "any further information becomes available." Oh yeah, I'm on their list baby!

Tuesday, February 14, 2006

Gen X Reps Revisited

My post yesterday regarding the differences between sales reps of the boomer generation vs. those of the Gen X cohort (see "Generation X Pharma Reps") sparked a few comments from readers of this blog. An anonymous commenter, who I suspect is an offended Gen X'er, doesn't buy any of it:
I think your memory is playing tricks on you, old timer. Remember the '80s and all that "greed is good" crap? Be they "baby boomers" or GenX'rs drug reps are pretty much the lowest of the low. End of story. -- Anon
Well Anon, you snot-nosed whippersnapper, greed is NOT necessarily all bad. If you were able to focus your computer-game addled, data-challenged brain on the survey data I presented, you would have seen that, for boomers, being well off was only slightly more important than participating in the community and slightly less important than keeping up with politics. On the other hand, Gen X'ers put greed way above all other motivational factors. In other words Anon, dude, you just don't have the balance that makes the spoils of greed worth having.

Even Michael Milken -- "junk bond king" and the great 80's icon of greed -- and Bill Gates -- the richest man in the world -- both exhibit this balance. Milken established a foundation to underwrite a search for the cure of prostate cancer and is a founder an educational services company. Gates established the Gates Foundation to help fight disease in poor areas of the world.

My friend and colleague Jane Chin (Gen X'er and member of the
PHARMA-MKTING online discussion group) contends that Gen X'ers took their cue from boomer managers:
I don't think Reidy is an apt characterization of Generation-X. While I - like Reidy - use "Dude" in select daily vernacular, I should point out that both I and Reidy live in Southern California where Dudes are fixtures to beach communities as Googlers are to internet communities.

As a member of Generation-X, I've noticed the stratification within Generation-X, which I have not seen addressed anywhere. The younger Generation-X (ones born in late 70s and in the 80s) were born into cultures of corporate cynicism. The older Generation-X (late 60s early 70s) like me grew up believing in employer loyalty and then evolved to see the errors of our ways in face of glorified lean operations, rainbow belts in six sigmas, and business process reengineering that usually means laying people off.

Forget the Way of Employee Empowerment, what Generation-X and Generation-Y have seen and continue to see is the Way of Dilbert and management doublespeak. We have grown up seeing management preach one thing and practice another: at the helm of drug industry scandals are senior management serving as examples to Generations X and Y as how one would get ahead at the company. There are members of the Baby Boomer generation who don't question dubious actions of management because one should "toe the line." There are members of the Baby Boomer generation who through their actions have taught members of Generations X and Y that when your connections are powerful enough or concealments clever enough, one does not have to play by the rules.

This is not about greed abounding and compassion lacking across generation divides. This is simply about greed knowing no bounds and compassion being made irrelevant when your performance is solely judged on how many pills you have sold this week.

Monday, February 13, 2006

Generation X Pharma Reps

I have very little in common with Jamie Reidy, the author of the book "Hard Sell: The Evolution of a Viagra Salesman," which is a tell-a-lot-but-not-all about pharmaceutical sales (see my review of this book in the upcoming February, 2006 issue of Pharma Marketing News). For one thing, Reidy is a Generation X'er (the cohort born between 1965 and 1980) and I am a boomer (the cohort born between 1946 and 1964).

The differences between Generation X'ers and boomers may help explain the decrease in pharma sales force effectiveness over the years.

One difference to consider concerns the importance of wealth vs. community as motivating factors for these two generations. A UCLA survey of college freshmen cited in the book “Bowling Alone” showed that Generation X'ers -- who were freshman in 1990 -- were much more concerned with achieving wealth than boomers who were freshman in 1970 (see chart). "Greed," says author Robert D. Putman, "trumps community" for Generation X'ers.

Greed -- i.e., the promise of a high salary, bonuses, expense account, and company car -- motivated Reidy to interview for the Pfizer sales rep job in the first place. Throughout the book he exhibits other Generation X traits, such as the frequent conversational use of the word "dude" as in "Dude, I need a little favor" and "Dude, pass the Viagra!" He is also frequently at odds with boomers, including his father and managers at Pfizer, especially when it comes to work ethic and other traditional values of older generations.

Reidy mentioned a Pfizer survey that revealed an "alarming high attrition rate" among reps with 4 to 6 years of service. In contrast to this are the Pfizer Masters -- sales reps whose sum of Pfizer service plus age equals at least 65 years and who have tremendous sales success. "Most of the Masters," quips Reidy, "still comb their hair the way they did when they first saw
Rebel Without a Cause in the movie theater."

UCLA Survey Chart

Greed alone may not be enough to motivate successful sales people. Maybe a little more sense of community -- caring about patients, for example -- might help. Nowhere in Reidy's book do I see any evidence that he really cared about patients. He was trained that "Most benefits [of drugs] revolved around saving a physician or her staff time and hassle", not about treating patients. And, according to Reidy, "nothing makes pharmaceutical sales people crazier than news of 'tab cutting'", a practice common among poor an elderly patients who cannot afford the high cost of drugs. "Dude, where's your compassion?"

Wednesday, February 08, 2006

FDA, Coupons, and Sleep Aid DTC Ads

According to a short piece in the Wall Street Journal, the FDA "is looking at whether coupons and rebates that are part of some prescription-drug advertisements might cause consumers to think a drug is safer or more effective than it really is."
The agency said it is concerned that consumers viewing advertisements that contain a coupon, a free-trial offer or other price promotion might place more emphasis on the benefits rather than the risks of a drug. "Coupons and price promotions may imply superior drug efficacy," the FDA said. [WSJ]
In a Federal Register notice (Docket No. 2006N-0029), FDA cited studies that show that people tend to rate owned objects more favorably than those they do not own, even when those objects have been assigned to them at random. This has been termed the "mere ownership" or "mere possession" effect. Other studies have shown that consumers rate a product more favorably when they are simply given a gift certificate or a coupon for that product or service.

For complex products such as prescription drugs where supervision of a physician is required to evaluate both appropriateness and performance, coupons and free trial offers may send signals that foster consumer misperceptions about the advertised prescription drug product, says the FDA. Thus, prescription drugs promoted with coupons or free trial offers may be seen as more widely indicated, more appropriate and/or less risky than they really are. Inclusion of a mechanism that affects consumers' perception of the product's risks is especially problematic in reminder ads because this type of ad contains no accompanying risk information. Furthermore, coupons and price promotions may imply superior drug efficacy.

What the FDA proposes is to do a study to examine the impact coupons have on consumers' perceptions of risks and benefits and the overall impression of the product in DTC full-product and reminder advertisements. Participants will be asked to read different versions of a single print advertisement for a new drug. Versions differ according to whether or not there is a free offer and the type of offer. After reading the advertisement, they will be asked questions about their evaluation of the information presented in the advertisement.

Sleep Aid Drugs Test Case

Here's the kicker: the study will be limited to one disease condition -- insomnia! It strikes me as no coincidence that insomnia was chosen. According to a story in today's New York Times,
Record Sales of Sleeping Pills Are Causing Worries.

As noted in a previous post, insomnia drugs are replacing ED drugs as the "bad boys" of DTC advertising (see "
Insomnia - the Next DTC Frontier"). As such, these ads will be getting increasing scrutiny. Already, we are seeing amnesia side effect stories that will become the subject of talk-show jokes. An example: an Air Force linguist in Qatar claimed to have been raped by another linguist, but she couldn't be sure. "[The victim] testified that she was not sure whether the incident was a dream because she had taken Ambien..." [NYT] One of the side effects of Ambien and other sleep aid drugs is amnesia and sleepwalking, or in this case, sleepraping.

[Another victim of Ambien sleepwalking raided a refrigerator in a seemingly unwholesome manner and later claimed not to remember. Ambien was also investigated as a factor in the Staten Island Ferry crash in 2003, but I'm thinking alcohol was more of a factor in that case.]

I haven't seen any Ambien or Lunesta DTC print ads offering coupons, but if the ED drug ad war is any indication, we are likely to see these ads. FDA, therefore, seems to be taking a pre-emptive strike and trying to gather data to back up future warning letters addressing these ads.

It is interesting to note that until recently Sepracor was running Lunesta reminder ads on TV. While not technically violating PhRMA DTC guidelines (see "PhRMA Finalizes DTC Principles"), Sepracor definitely pushed the envelope. One can expect that Sepracor is or will run reminder print ads since these ads are NOT covered by PhRMA Guidelines. And my guess is that some of these ads are likely to include coupons. Hence FDA's concerns.

Tuesday, February 07, 2006

Cialis Blog Shut Down

Not exactly shut down, but close enough!

A few days ago I reported that cialisblog.com was apparently using the Cialis brand logo without the consent of Lilly ICOS -- although I questioned how this could have been going on for over a year after the blog was mentioned in Pharmaceutical Executive (PE) Magazine.

I contacted Google and Blogger.com, which hosts cialisblog.com, to complain that the site was in violation of Blogger.com's terms of use (namely, using a trademark without the owner's permission). No response.

I then sent the following e-mail not to ICOS's general counsel:

From: JOHN MACK [mailto:johnjmack@verizon.net]
Sent: Friday, February 03, 2006 11:26 AM
To: generalcounsel
Subject: Cialis Brand Logo infringement
Importance: High

Dear sir or madam:

It has come to my attention that a rogue web site (www.cialisblog.com) is using the Cialis logo and thus misrepresenting the brand. I just thought you would want to protect your brand's integrity and have this unauthorized use of the Cialis logo stopped.

It would be a simple matter to contact Google or Blogger.com and have them take down the site, which violates their terms of use.

Please advise me on your action, as I will be reporting further on this issue in my newsletter, web site and blog (see http://pharmamkting.blogspot.com/2006/02/cialis-blog-shame-on-lilly-icos.html) which reaches over 40,000 readers per month.
And wouldn't you know, I got a reply!
Dear Mr. Mack:

Thank you for your note regarding the site at www.cialisblog.com . We monitor the Internet on a regular basis and take action as appropriate to prevent the unauthorized use of our trademarks by third parties. We are aware of this site and will follow up according to our standard processes.

John Kliewer, Vice President and General Counsel
Now when you visit cialisblog.com, this is what you find:
CialisBlog is not affiliated with Lilly ICOS

Rercent (sic) articles in various newspapers mentioned CialisBlog.com as belonging to Lilly Icos. CialisBlog is no way affiliated, endorsed, or sponsored Lilly Icos.

CialisBlog is not an attempt to hijack the Cialis brand. The site contains only news and information about Cialis and makes no claims whatsoever as being affiliated with Lilly Icos.
You know what people from New York would say to that? "Yeah, if you believe that, then I have a bridge to sell you!" Anyway, the logo has been removed. Success!

Why did it take so long after cialisblog was mentioned in PE Magazine in October, 2004, for someone to notify Icos? You would think that ONE of the thousands of readers of that prestigious trade publication would have said something! Maybe someone did, but unfortunately it took a more public outing to get action.

Thanks to Fard Johnmar for bringing this to my attention in the first place.

NOTE ADDED: A commenter suggested it was impossible to monitor all the sites -- like cialis-blog.com -- that use the name Cialis.

That is true, but these sites do not use the Cialis graphical logo. Anyone can use the name of a product. That's protected by free speech in many cases and may not be purposely deceptive. But using a graphical logo takes it to level another level, into the realm of purposeful deception and misrepresentation. That's why I do not believe that cialisblog.com when it says it did not intend to hijack the logo to misrepresent itself as being an "official" Cialis site. Obviously, the ruse worked and several of us savvy editor-types believed it was an official Cialis site. Also, the signature was "Cialis" as the creator ("Who am I"), whereas I am sure is not the case in other sites using the Cialis name.

It is also suspicious that the identity of the site's creator was hidden and difficult to pin down. I actually believe the site was sanctioned by Icos and/or Lilly who were put up to it by an overzealous ad agency or PR firm who hid their tracks. Maybe a zealous sales rep is responsoble. Who knows?

It might be instructive to ask the editor of PE mag how the site got mentioned in their magazine (although I am sure they will claim not to remember). Very few references to these things are made in the press without the editor first being informed of the existence of the site by a PR person and doing some fact checking. But that's a whole 'nuther matter!

Friday, February 03, 2006

Michael Moore Seeks "Sickos"

As you might guess, I am on Michael Moore's mailing list -- aren't you? -- and every once in a while I get an e-mail message from him on some issue he feels strongly about. [Get a blog, Michael!]

Today, I received an appeal from Moore seeking people to make famous for 15 minutes by putting their healthcare horror stories in his film "Sicko" and thereby giving people "a chance to bring down this evil empire, once and for all."

BTW, he's not just talking about the pharmaceutical industry as some of you have supposed. He's talking about the entire healthcare industry and seems especially focused on HMOs (I reproduce his appeal below).

[Appeal from Michael Moore]
How would you like to be in my next movie? I know you've probably heard I'm making a documentary about the health care industry (but the HMOs don't know this, so don't tell them -- they think I'm making a romantic comedy).

If you've followed my work over the years, you know that I keep a pretty low profile while I'm making my movies. I don't give interviews, I don't go on TV and I don't defrost my refrigerator. I do keep my website updated on a daily basis (there's been something like 4,000,000 visitors just this week alone) and the rest of the time I'm... well, I can't tell you what I'm doing, but you can pretty much guess. It gets harder and harder sneaking into corporate headquarters, but I've found that just dying my hair black and wearing a skort (sic) really helps.

Back to my invitation to be in my movie. Have you ever found yourself getting ready to file for bankruptcy because you can't pay your kid's hospital bill, and then you say to yourself, "Boy, I sure would like to be in Michael Moore's health care movie!"?

Or, after being turned down for the third time by your HMO for an operation they should be paying for, do you ever think to yourself, "Now THIS travesty should be in that 'Sicko' movie!"?

Or maybe you've just been told that your father is going to have to just, well, die because he can't afford the drugs he needs to get better -- and it's then that you say, "Damn, what did I do with Michael Moore's home number?!"

OK, here's your chance. As you can imagine, we've got the goods on these crooks. All we need now is to put a few of you in the movie and let the world see what the greatest country ever in the history of the universe does to its own people, simply because they have the misfortune of getting sick. Because getting sick, unless you are rich, is a crime -- a crime for which you must pay, sometimes with your own life.

About four hundred years from now, historians will look back at us like we were some sort of barbarians, but for now we're just the laughing stock of the Western world.

So, if you'd like me to know what you've been through with your insurance company, or what it's been like to have no insurance at all, or how the hospitals and doctors wouldn't treat you (or if they did, how they sent you into poverty trying to pay their crazy bills) ...if you have been abused in any way by this sick, greedy, grubby system and it has caused you or your loved ones great sorrow and pain, let me know.

Send me a short, factual account of what has happened to you -- and what IS happening to you right now if you have been unable to get the health care you need. Send it to michael@michaelmoore.com. I will read every single one of them (even if I can't respond to or help everyone, I will be able to bring to light a few of your stories).

Thank you in advance for sharing them with me and trusting me to try and do something about a very corrupt system that simply has to go.

Oh, and if you happen to work for an HMO or a pharmaceutical company or a profit-making hospital and you have simply seen too much abuse of your fellow human beings and can't take it any longer -- and you would like the truth to be told -- please write me at michael@michaelmoore.com. I will protect your privacy and I will tell the world what you are unable to tell. I am looking for a few heroes with a conscience. I know you are out there.

Thank you, all of you, for your help and your continued support through the years. I promise you that with "Sicko" we will do our best to give you not only a great movie, but a chance to bring down this evil empire, once and for all.

In the meantime, stay well. I hear fruits and vegetables help.
Viagra, the Movie
As if the pharmaceutical industry did not have enough to worry about, another anti-pharma movie possibly in the works is based on the tell-all book "Hard Sell: The Evolution of a Viagra Salesman." This bit of news made front page of Variety, baby! "The book will form the basis for a fictionalized film about the pharmaceutical supply biz," according to Variety. "Pharmaceutical supply" -- that's rich!

Another Million Little Pieces?

From what I read in reviews on Amazon.com,
Hard Sell appears to be a memoir based on "true stories." One reviewer, a doctor, wrote: "I know what drug reps do from my role in the system, but for other readers, there will be even more revelations of secrets here than there were for me." I wonder, however, how much of the author's story has been, let's say, embellished reminiscent of another memoir in the news these days?

I haven't read
Hard Sell, but now it looks like I should because it covers pharma samples and gifts to physicians, a topic I will be writing about in the next issue of Pharma Marketing News. For more on that subject, see "Gifts That Keep on Giving."

Wednesday, February 01, 2006

Cialis Blog -- Shame on Lilly ICOS

In the Pharma Marketing News article "Blogs and the Pharmaceutical Industry," I made a passing reference to www.cialisblog.com as an example (albeit a BAD example) of a blog sponsored by a pharmaceutical company. Here's what I said:
Consider www.cialisblog.com, an ICOS blog about the ED drug Cialis. This blog violates several blogging principles. Most importantly, it lacks a "human voice."” Most posts to the blog appear to be company press releases and are signed "Posted by Cialis."” This may be an attempt to establish rapport with the brand, but it doesn't work. The second problem is that posts are infrequent. Strangely, some posts are focused on ICOS profit data and have nothing to do with Cialis at all!
My friend and fellow blogger, Fard Johnmar, over at Invisioning 2.0, pointed out to me that Lilly ICOS is attempting to distance itself from any responsibility for the blog. According to Johnmar:
"It turns out that the Cialis blog is not endorsed by the powers that be at Lilly ICOS, according to Lilly spokesperson Kindra Strupp... I'’m not sure what caused the confusion about the blog, but it may have been the fact that the blog features the Cialis logo prominently and provides information about Cialis clinical trials. Prior to my contacting Lilly, the company was unaware that the Cialis blog existed."
Pharmaceutical Executive Magazine, according to Johnmar, "reported in October 2004 that 'Eli Lilly and Icos . . . publish the Cialis Blog' (www.cialisblog.com). Given this report, it appeared that Lilly ICOS had successfully managed the numerous legal and regulatory issues associated with developing and publishing an offical (sic) blog."

I found out about the Cialis blog from the piece in PE. If I read it, I am sure someone at Lilly ICOS read it too. That Lilly ICOS is now saying they were, until now, unaware of the blog is too far-fetched to be believed.

If Lilly ICOS was truly unaware that the Cialis logo was being misused then that just demonstrates incredible incompetence on their part. If you can't control your corporate assets -- and your logo is a VERY important one -- then you should be shot, business-wise.

Johnmar tells me that the Lilly ICOS spokesperson also said it was "out of their control." That defense would not play well in Peoria nor in Rockville. It's a lame and indefensible excuse and I am surprised that it was offered by an official spokesperson. So, either Lilly ICOS is lying or they are inept or they are not taking any responsibility for proactively fixing the problem (unlike Pfizer, I might add, that vigorously protects its Viagra brand from counterfeit). Any way you slice it, shame on Lilly ICOS!

Now that Kindra knows I hope Lilly ICOS will take swift action and halt the hijack of the Cialis brand logo and at least force its removable from a blog that disguises itself as an official Cialis site. That should be easy. The blog is hosted by Google Blogger, which should be able to pull the plug, especially if it receives a threatening call from Lilly ICOS's legal department (you do have a legal department, don't you Kindra?).

Meanwhile, what would DDMAC think of all this if someone were to send them a screen shot of the Cialis Blog?

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