Pharma Marketing Blog

If you buy the book "A Call to Action" by Pfizer's CEO, Dr. Hank McKinnell, with the notion that you will learn what this pharma executive believes the industry should do to reform itself, you are in for a big surprise. Notwithstanding an Amazon.com review of the book written by Peter Rost – Pfizer’s whistleblowing, soon-to-be non-head of Pfizer's endocrine care marketing unit and “Pharma’s Black Knight” – in which McKinnell is described as making “an impressive mea culpa,” this book is actually a mea non culpa!

I had reason to expect to see suggestions for changes in the way pharma operates because at the very beginning of the book (page 13), McKinnell said that “if Pfizer wanted a seat at the table where important healthcare solutions were being hammered out, we had to earn it by acting differently, partnering differently, and communicating differently.” Unfortunately, the rest of the book does NOT carry through on this theme and focuses instead on how consumers, society, employers, managed care, and government need to act differently.

Before getting to the action items, McKinnell tries to answer the most important questions put to the industry by critics and the public. These questions are:

• Why are Prescription Medicines So Expensive?
• Why Does the Industry Do So Much Advertising?
• Why Do Americans Pay More Than Canadians for Drugs?

Unfortunately, McKinnell sticks to the standard pharma industry playbook except on one or two occasions where he seems to offer contrary opinions.

Why are Prescription medicines So Expensive?
It turns out, according to McKinell, that drugs are not as expensive as you think (silly you!) and that branded drugs are cheaper than the alternative – the old “an ounce of prevention is worth more than a pound of cure” defense.

In essence, his argument is, drugs are not as expensive as you think, cheaper alternatives are soon available, and drug profits are good and well deserved.

I should acknowledge at least one refreshingly contrary view expressed by McKinnell: an admission that it is a “fallacy to suggest that our industry…prices a product to recapture the R&D budget spent in development.” He suggests instead that it is “investors’ confidence in the risk and rewards” that drives prices.

McKinnell takes exception to critics such as Senator Bill Frist who claim that “increased direct-to-consumer advertising has helped fuel escalating drug costs” (See "Deconstructing Frist on DTC"). McKinell, like PhRMA, insists that “studies show there’s no correlation between prices or price increases and DTC advertising.”

McKinnell cites a study done in 2001 by The National Institute for Health Care Management entitled “Prescription Drug Expenditures in 2000: The Upward Trend Continues.” McKinnell claims that this study shows that the “average price of drugs that are advertised is lower than those that aren’t.” The report, however, concludes that the increase in prescription drug spending is due, in part, to “more aggressive marketing of prescription drugs to both doctors and consumers.”

Why Does the Industry Do So Much Advertising?
McKinnell wants us to believe that DTC advertising is really education (he prefers ro call it “DTC education”). This is not a new mantra. Johnson & Johnson Chief Executive William Weldon, for example, said in an address to PhRMA: "Our communication with patients should really be thought of as Direct to Consumer Education” (see “DTC Straight Talk”).

Why Do Americans Pay More Than Canadians for Drugs?
To be honest, I didn’t read this chapter. According to Peter Rost, “McKinnell … admits that drugs from Canadian pharmacies are safe …[and] that ‘perhaps pharmaceuticals represent too low a percentage of total healthcare spending’ and he calls for ‘price controls to be lifted’ around the world, because “It is time for Canadians and others to pay their fair share.”

A Call to Action Starts Here
Chapter 13 is the chocolate nugget of the book. In this chapter McKinnell lists 10 actions that he believes should be taken to reform the healthcare system in the U.S. Only one action on the list, Reform Direct-to-Consumer Advertising, is an action item for the drug industry. All the others are the responsibility of individuals, society, employers, managed care, and governments, not the pharmaceutical industry. Coincidentally, at least six actions would either benefit the pharmaceutical industry in general or highlight specific Pfizer initiatives. Rather than focus on these – you can read more about it in the Summer 2005 issue of Pharma Marketing News – I’d like to focus on Mickinnell’s suggestions for reforming DTC.

Reform Direct-to-Consumer Advertising
This is the one action item mentioned in the book that applies directly to the pharmaceutical industry and can be said to require a change in the way it does business. Here’s what McKinnel recommends for DTC:

• Improve communications about risk
• Provide information about alternative therapies available, including therapies that do not require a medicine
• Promote prevention and wellness, compliance with treatment regimens, and disease awareness
• Promote access to medicines and do a better job communicating about patient assistance programs
• Implement external oversight of DTC, including working with the FDA to get their views on advertisements before they are run

Mckinnell’s action plan for DTC reform, however, does not go as far as some other emerging principles do. He does not suggest, for example, a 1-year moratorium on DTC for news drugs or to limit TV ads to the appropriate audience at the appropriate time of day (something that Congress may impose on ED ads). Both of these principles have been adopted by Bristol-Myers Squibb in its Direct-to-Consumer Communications Code. It should be noted, however, that McKinnell has said in another venue “No erectile dysfunction drug ads on television except for 10 pm to 6 am. I'm in favor of that.” (Washingtonpost.com Viewpoint interview, 2004).

Needless to say, this book is not going to shake up the pharmaceutical industry nor does it offer much new defense against critics of the industry. It often sounds like an advertorial for Pfizer’s programs. A Pfizer spokesman referred a reporter to McKinnell's book as the “best source” for the company’s perspective on advertising. I wouldn’t recommend it, however, as the best source for an action plan to reform drug advertising in general.

The Pharmaceutical Research and Manufacturers of America (PhRMA), which represents the country’s leading pharmaceutical research and biotechnology companies, has sent out a trial balloon regarding its DTC Voluntary "Guiding Principles" (see "DTC Voluntary ‘Guiding Principles’ Receive Preliminary Approval by PhRMA Board of Directors").

By using a press release to reveal a few tantalizing glimpses of "areas addressed," PhRMA and its member companies, which have yet to review the guidelines, can gauge the public response and tweak the language. That's fine.

I hope they are listening.

The big item missing from the guidelines -- and I predicted back on July 5 that it would be missing (see "To Ban or Not To Ban DTC, That is the Question") -- is any talk of a ban on DTC.

The following are some of the guidelines PhRMA mentioned in its press release. PhRMA claims that these "go beyond current FDA regulations."

Conversations with physicians prior to the launch of a new direct-to-consumer campaign.

“I will be watching this issue closely. And if the pharmaceutical industry’s voluntary restrictions aren’t strong enough, I’ll support Congressional action to make sure consumers get the protection they deserve. If these voluntary restrictions don’t do the job, I believe Congress should act.”

Ok, Bill. Your move!

When the leading Republican member of Congress and a contender for the next president of the United States says it'’s time for the pharmaceutical industry to "clean up it's act" and suggests banning DTC advertising of new drugs for 2 years after launch (see "To Ban DTC or Not to Ban DTC, That is the Question"), you know that you are in trouble.

Should the industry fight back or "suffer the slings and arrows of politicians" until it all blows over? If it fights back, how should it fight back?

Many believe that the pharmaceutical industry is too timid and does not fight back when kicked (see, for example, "Marketing the Pharma Industry: The Empire Strikes Back" in the upcoming Summer 2005 issue of Pharma Marketing News).

The facts, however, do not support this view. According to a Center for Public Integrity investigation, the pharma industry lobbying efforts are "second to none"” (see "“Drug Lobby Second to None: How the pharmaceutical industry gets its way in Washington"). It has spent more than $800 million in federal lobbying and campaign donations at the federal and state levels in the past seven years and employs more registered lobbyists (625) than there are members of Congress. So let'’s not shed any crocodile tears regarding the industry's ability or will to fight back.

I am not privy to all the ways that the drug industry is fighting back against efforts to limit DTC and to be more transparent about drug side effects. In public statements the industry sometimes appears very timid, especially when criticizing reforms suggested by its political friends. The handling of comments by Bill Frist is an example. Behind closed doors, however, I am sure industry lobbyists and supporters are employing the strongest arms they have to twist Frist's arm and make him say "“uncle."

The industry is also employing PR and pharma CEOs are writing books (see "“A Call to Action: A Mea Non Culpa"” in the upcoming Summer 2005 issue of Pharma Marketing News) to push its main arguments that prescription drugs are not expensive, importing drugs from Canada is dangerous (they won this argument), and DTC advertising is really direct-to-consumer education.

I don'’t think the drug industry will win the DTC moratorium argument. Instead of following PhRMA's head-on confrontational approach and fighting such "bad policies"” and issuing voluntary codes of conduct, the pharmaceutical industry should push for a compromise that has some carrots in it for the industry.

My suggestion is to negotiate on two issues: a selective rather than universal DTC ban and extension of patent life of drugs.

Instead of an arbitrary ban on DTC for all new drugs, why not just ban DTC advertising of new drugs that have known serious side effects? Furthermore, the restriction could be provisional upon completion of post marketing studies that prove the safety of the drug in the marketplace. Incentives to holding back DTC ads could include extending the drug's patent life and preventing other companies from marketing "‘me-too"’ type of drugs while the advertising prohibition is in effect.

Pharmaceutical meetings and events have become an integral component of the drug industry's promotional efforts used to gain face time with physicians. According to a Verispan Sales Force Effectiveness audit in 2004, 63% of physicians surveyed considered rep-arranged meetings and events to be more or much more effective than a traditional detail. Only 12% characterized events as less or much less effective. Versipan Press Release.

Hiring a doctor as a speaker and providing a free meal for the attendees is still acceptable -- and, data suggest, highly effective. An internal study done by Merck & Co. several years ago calculated the "return on investment" from doctor-led discussion groups was almost double the return on meetings led by the company's own sales force. WSJ.

According to the document, doctors who attended a lecture by another doctor wrote an additional $623.55 worth of prescriptions for the painkiller Vioxx over a 12-month period compared with doctors who didn't attend. Doctors who participated in the more intimate discussions wrote an additional $717.53 worth of prescriptions for Vioxx, which Merck pulled from the market last year over concerns about cardiovascular side effects. That compared to an increase of only $165.87 in Vioxx prescriptions by doctors who attended a meeting with a salesperson. WSJ.

"However, many pharma companies lack interest in the return on education investment or ROE data our programs are able to provide," says Jan Heybroek, Vice President at Imedex, Inc., an accredited worldwide CME provider located in Alpharetta, Georgia.

"An awful lot of the doctors in the audience are naive about the fact that these are really sales talks," says Jerry Avorn, a professor of medicine at Harvard Medical School and author of a recent book that criticized drug companies' marketing.

The upcoming Pharmaceutical Public Relations & Communications Summit will feature many presentations from pharmaceutical communications and PR specialists who will attempt to offer advice on how to make pharmaceutical crises "go away." That's an explicit goal of at least one workshop and it is the subtext of most of the other presentations.

Here's a partial list of the topics or tactics to be discussed:

• The impact of drug pricing, drug safety and regulatory violations on public perception: Lessen the knowledge gap
• Conveying your message to all of industries stakeholders, patients, consumers, providers, Capital Hill and more
• The impact of foundation work and community partnerships on perception
• How Pharma Can Best Work With Physician and Celebrity Spokespersons
• Displaying The Value of Medicine in your Corporate Communications
• Partnering with Patients to Clearly Demonstrate the True Value of Medicine
• Examine an award-winning campaign that highlights partnerships one company has formed with philanthropic, government and nongovernmental agencies for more than 100 years
• Going to the Higher Ground with Medical Societies in Advocacy Development

1. Drug prices are not the culprit (there's a "knowledge gap" that has to be neutralized)
2. Medicines are valuable
3. The drug industry is noble and donates a lot of money to philanthropic causes

• Physicians and their medical societies
• Celebrity spokespeople
• Patient advocacy groups

FROM THE PUBLISHER
From a business standpoint, your organization can benefit from developing a two-pronged approach to blogging by creating offensive and defensive plans. Not only do you need to blog internally to promote ideas and foster better communication among colleagues, but your company also should take advantage of the advertising and publicity benefits of blogging. Put yourself at the front of people's minds, and make sure you stay there. As for a defensive strategy, create a plan for addressing immediately even one negative blog, because in just a click of a mouse it will spread like wildfire, and you'll soon have one hundred negative blog references out there, and then a thousand or more. Blog shows you how to develop both.

Drug Labels

Question: How many medical and communications experts does it take to write a package insert?
Answer: None. That's a legal problem, not a medical communications problem.

"Labels have become dumping grounds for drug-company legal departments seeking to ward off product-liability lawsuits. Some labels are larded with nearly every problem ever reported with the medicine, from animal tests up to widespread clinical use. The way these adverse reactions are described isn't consistent from drug to drug, either. The sheer volume of information dilutes the power of the truly important."

"The industry spent $388.5 million on consumer drug ads on network TV in the first quarter, down about $44 million from last year, says Nielsen Monitor-Plus."

What If There Were No DTC?

When I posed this question to members of the PHARMA-MKTING online discussion group it resulted in a flurry of feedback from members. I would like to reproduce some of that feedback here and focus on an alternative to DTC --– disease state awareness (DSA) advertising, which is getting more traction these days among pharmaceutical marketers. I will argue that replacing branded DTC with non-branded DSA may create a new problem -- what I call "indication bloat," or redefining a disease to increase the scope of the approved indication for a drug.

My comments are enclosed in brackets [].

Brian, a consultant from the UK, started the debate off by asking "“Is this really that important, in the big scheme of things?"

He went on to say:

"Sure, if you're one of the agencies promoting a big profit opportunity to the gullible masses of the American heartland, there are jobs & profits at stake.

"“As far as the DTC debate is concerned, I am firmly on the side of banning any kind of named brand advertising direct to the potentially sick and willingly misled. Sticking ads for prescription medications in, amongst and alongside ads for butter, breakfast cereal and pantyhose is fundamentally wrong. (And ethically and morally corrupt)."

"“Many of us would not mourn the demise of DTC from a pecuniary perspective. I personally don't profit a whit from it. And the Vioxx case certainly is an example of creating plaintiffs, not profits.

"The right path is probably the one being pursued--a voluntary moratorium until enough time has passed for side effects to manifest and more emphasis on disease awareness as opposed to product ads."

"“Would a ban on DTC really lead to better and healthier lives for people? If the practices and controls over the execution of clinical studies and the dissemination of the results do not improve, then many of the same risks will still remain. Are there not examples of safety issues before DTC? Scale you might say, it is the scale! DTC spreads the usage of new drugs far and wide without enough validation of safety and efficacy/benefits. True. But is that all?

"“We should really examine how much different this 'launch momentum' will be without DTC. There are more reps, more products and more ways to reach physicians. And more wall street pressure on drug companies to meet the numbers. Taking DTC out of the launch equation may have some effect but not enough to really guarantee minimal exposure to safety issues."

"Sorry, Brian, but there is tons of data to show that DTC brings patients into the doc's office - people who would otherwise be undiagnosed and untreated. ... One of the biggest healthcare problems in this country is the undiagnosed, untreated and under-treated patients who consequently have poor outcomes and consume resources at a greater rate than those who are property diagnosed and treated."

"“In markets where DTC (on a brand named basis) is not permissible, companies are allowed in many cases to promote by therapeutic concern/area, and tell customers that if they have this or that problem, a solution can be discussed with their primary care physician. I have worked on a number of these myself, and would agree that information encouraging individuals to present with symptoms and signs that they may have chosen to ignore.

"“Not so much DTC as ITC (Indirectly to Customer)."

Last week Senate Majority Leader Bill Frist, (R., Tenn.) shocked the pharma and advertising industries by calling for pharma to ban DTC advertising for new drugs for the first 2 years on the market (see "To Ban or Not to Ban DTC, That is the Question").

Frist, in his statement read on the floor of the Senate, cited quite a few studies and data about DTC. I thought it might be useful to reproduce parts of his statement here and deconstruct what he says to help provide further insight and balance.

-July 1st, 2005 - Mr. President:

Let me begin with a few phrases:
• “Keep the spark alive;”
• “The healing purple pill;”
• “If a playful moment turns into the right moment, you can be ready;”
• “For everyday victories.”

Turn on you TV – any time of day -- and that’s what you’ll see.

[What you won't see is Bob, the Enzyte guy. See "The Two Bobs: Enzyte vs. Viagra."]

[That's called frequency in advertising. In order to drum the message into people these days, advertisers have to be much more repititious, or so the conventional thinking goes. People are just not paying as much attention to ads as they used to. Permission-based marketing may be a better solution that could have saved the industry from this type of criticism, if only they listened. For more on this topic, see "Out-of-the-Box Marketing: Will It Work for Pharma?"]

[Here Frisk throws in a reference to Nascar in order to bond with "Joe Six Pack" voters. A calculated political gambit if ever I saw one. I don't know if there is a Purple Pill race car, but I think there is a Viagra one. As we get further into this analysis, you might begin to think Frist is pre-occupied with ER drugs. In any case, it is obvious that the ED ads have done great damage to the industry by pushing the envelope and offering themselves up as the archetypical DTC ads and easy targets for critics. For more on this topic, see "Are ED Ads Too Sexually Explicit"]

[I object to the phrase "over the heads of doctors." It makes it sound like doctors unanimously oppose these ads.]

[Don't expect PhRMA to let that slide. See "PhRMA Statement on the Value of Direct to Consumer Advertising," which states: "Evidence does not link advertising and drug prices." PhRMA doesn't cite the source of this evidence, but what the heck, I'll take their word for it.]

[There's a name for this type of specious argument. I'm too lazy to look it up. Everyone will agree with the conclusion of the argument: misleading advertising hurts patients. The problem is, Frisk just said that "a lot" DTC ads misleads patients and DTC "may" do this and "may" do that. He does not offer any evidence for the premises of his argument that leads to the conclusion.]

[A government study is always a good way to keep your name in the news or at least revisit the issue again and again.]

[Oh boy! How many times have I said that? I don't know. But I can tell you that the drug industry didn't listen.]

[I'd have to agree with Frist on this point. See, for example, "Is DTC Educational or Motivational?"]

[See what I mean about those ED ads being too good a target to pass up?]

[Blame it all on Clinton and those liberals! Later on Frisk does allow that Clinton was under intense pressure from the drug industry. Anyway, as I remember, Congress was controlled by the Republicans. The pesky liberals were blocked on many other issues, so why didn't the Republicans do something about this "liberalization" back then? Here, I believe, Frisk is establishing battle lines between himself and Clinton -- Hillary that is -- that will inevitably be drawn in 2008.]

[The FDA has stuck to its guns about how risk should be conveyed in drug ads. That is, less is more. See, for example, "Can Drug Ads Communicate Risk?"]

[I think this is an attempt to rewrite history a bit and avoid having the Bush administration take a share of the blame. If anything, the 1997 FDA guidance give the industry an inch and they took a mile. BTW, if the FDA were more vigilant and less cozy with the drug industry, we wouldn't be talking about banning DTC today. See, for example, "The House(s) That Troy Built" in a recent post to this blog. Daniel Troy, former chief counsel to the FDA, was Bush's first FDA appointee. "Troy managed to restrict FDA's ability to use its statutes creatively, and this in turn deterred mid-level managers from advocating new approaches to emerging scientific issues, leaving the agency looking - and feeling - weak." (See "FDAers Think Troy Weakened Them, Worry About Masoudi").]