Monday, July 25, 2005

McKinnell's Mea Non Culpa

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 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.” ( 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.

Friday, July 22, 2005

PhRMA Rules Come Up Short

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.
Without more details, I don't really know what this means. Does it mean that DTC ads will be delayed after launch until companies have docs take a look at them? or will they hire docs to be on focus groups duriing the development of the ad campaign?

Whatever it means, this doesn't seem too much of a hurdle. After all, there are docs out there that will do virtually anything for a buck!

For this process to have any real merit, an independent physician review board would have to be set up to approve ads BEFORE they are launched. Why not, therefore, submit ads for prior approval to the FDA who could assemble this kind of physician review like they do with other advisory committees?

This is what Bristol-Myers Squibb pledges to do (see "
New DTC Principles Emerging").

The CEO of Pfizer, Hank McKinnell, in his book "A Call to Action," suggested the following DTC reform principle:
"Implement external oversight of DTC, including working with the FDA to get their views on advertisements
before they are run." I hope Dr. McKinnell fights to get this principle in the final PhRMA code.
TV advertisements should be targeted for audience and age appropriateness.
Hopefully, this means running ED drug ads late at night and not during family sports events.

McKinnell is also in favor of this: “No erectile dysfunction drug ads on television except for 10 pm to 6 am. I'm in favor of that.” ( Viewpoint interview, 2004).

It's also part of the BMS code.

Companies should promote health and disease awareness as part of their advertising.
They already do this, so this is not new and it does not go "beyond" current FDA regulations.

Now, if pharma companies focused on disease awareness ads instead of branded DTC, then that would be new. BMS also pledged to do exactly that.

Companies are encouraged to include information about assistance programs for the uninsured and low-income.
I have no qualms about this although it is less about a DTC principle than a promotional statement of another kind.

All in all, I think PhRMA needs to go back to the drawing board on these principles. The political winds have shifted dramatically since they started this project. Most significantly, Senator Bill Frist has called upon the industry to do more. Specifically he has called for a 2-year moratorium on DTC ads for new drugs (see "
To Ban or Not To Ban DTC, That is the Question").

If the PhRMA press release offers an accurate glimpse as to what the final principles might be, then I have to say that PhRMA is woefully unprepared to lead the industry's negotiating efforts.

Remember, what Senator Frist said:

“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!

Thursday, July 21, 2005

Restrict DTC, but Extend the Patent for New Drugs

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.

Friday, July 15, 2005

Physician Education vs. Promotion

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.
An article in today's Wall Street Journal ("To Sell Their Drugs, Companies Increasingly Rely on Doctors") offers an explanation of why physicians might consider pharma-sponsored meetings more effective than traditional details: it's the money! Also, the free food.
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 Merck documents cited in the article, the "return on investment" of doctor-led discussion groups is 3.66 times the investment, versus 1.96 times for a meeting with a sales representative.
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.
Return on Education
These meetings are supposed to be educational and non-promotional. One doc who often speaks at such meetings was quoted as saying to his pharma sponsor: "Your job is to sell the drug and my job is to educate."

Measuring ROI of educational meetings is considered unacceptable by continuing medical education standards and may indicate a breakdown in the "firewall" that many pharma companies have erected between promotion and education.

If the budget for education no longer comes from the marketing team but from professional services, then there should be no measurement of "return on investment" in the traditional sense: i.e., in which new prescriptions written are tracked after physicians receive education.

Some physician education professionals prefer to talk about ROE or return on education (see, for example, "A Strategic Approach to CME Offers High Return on Education Investment").
"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.
Training vs. Promotion
Aside from the ROI issue, the article touches on another sensitive issue regarding education vs. promotion: paying physicians as "consultants" to attend meetings, the purpose of which is to "train" them as speakers.

Pharma companies may pay physicians $750 to attend such meetings in exchange for agreeing to be speakers. It is claimed that many attend, but few are called upon to fulfill their obligation to speak.

A Pfizer spokeswoman -- why are pharma spokepeople invariably women and not men? -- was quoted as saying: "We would never knowingly train them and not use them."

Yes, because to do so would violate the "PhRMA Code on Interactions with Healthcare Professionals" (also see "PhRMA Code Helps Re-define Roles of Medical Affairs and Marketing") as well as risk running afoul of the HHS' Office of Inspector General (OIG), which can fine you big time!

Are Docs Naive?
Critics claim that many docs naively believe that pharma-sponsored meetings are non-promotional:
"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.
Please excuse me while I LOL.

I haven't read Avorn's book, which has gotten good reviews on, but it's difficult to believe that intelligent, professional people with over 20 years of schooling would confuse promotion with education.

Thursday, July 14, 2005

Transparency: A New Voice for Pharma

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
From this I infer the PR strategy for dealing with the current pharmaceutical crisis can be boiled down to starting with the right message:
  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
and eliciting the help of the following advocates to bring the message to the public and Congress:
  • Physicians and their medical societies
  • Celebrity spokespeople
  • Patient advocacy groups
The industry's strategy seems to be all about spin and damage control and nothing about transparency or using other, non-traditional approaches.

Sometimes, it seems that the industry merely cranks out PR about being transparent without actually being transparent.

Last year, for example, pharma companies announced initiatives to list all pharma-supported clinical trials on Web sites. Yet a Boston Globe article published in January entitled "Drug firms lagging on openness" states "six months after the drug industry vowed to make its clinical trials more transparent, and three months after launching a common website to give the public 'unprecedented access' to studies both good and bad, drug companies have posted unpublished trial results on the site for just five drugs."

Maybe things have changed since January regarding the situation with clinical trials, but there are signs that pharma companies are still having problems with the transparency thing. PhRMA, for example, seems to have qualms about FDA's plan to post "unvalidated" safety data on it proposed Drug Watch Site (see "Drug Risk Survey Results" published in a recent issue of Pharma Marketing News).

Blog: Information Reformation
The aforementioned conference includes a few "Ocean View Roundtable Sessions" that may be more interesting than the formal presentations. One roudtable will be moderated by my friend Mark Bard, president of Manhattan Research. This roundatble is titled: "Blog: Understanding the Information Reformation That's Changing the Pharmaceutical Industry."

The title of the roundtable comes from the book "Blog: Understanding the Information Reformation that's Changing Your World" by Hugh Hewitt.
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.
I am not sure how ready the pharmaceutical industry is to "take advantage of the advertising and publicity benefits of blogging." From my limited discussions with pharma people, the industry doesn't see any benefits of blogging at all.

However, I suggested what a pharma company PR blog might look like in a previous post to this blog (see "
Patients Come First?").

Pharma PR Needs a New Voice: Employees!
The vast majority of employees, managers, and executives at pharmaceutical companies are very dedicated and honest people that want to do the right thing and implement PR slogans like "Patients come first" in their jobs. But they are almost always muzzled (see, for example, "Peter Rost: Pharma's Black Knight").

Here's what I propose. Instead of fancy, expensive ads or PR campaigns, why don't pharma companies interview a few employees and let us hear directly from them? Better yet, pharma companies should start blogs and have employees contribute. This may give the industry a credible voice to counteract all the outside voices railed against it.

This strategy would take a page from the White House's playbook regarding Karl Rove damage control: have surrogates promulgate your talking points via populist channels. In this case, have pharma employees as spokespeople. I'm not talking about CEOs, but regular employees. Wal Mart ads do this well.

I don't think the public will look upon low level-pharma industry employees (secretaries, bench scientists, etc.) as "shills," whereas other surrogates -- physicians, celebrities, etc. -- may be viewed that way.

There have been a few ads featuring pharmaceutical personnel -- especially researchers. This may be a good model to transition to blogs through which personnel can contribute their thoughts and opinions.

Wednesday, July 13, 2005

Labeling / TV DTC Revisited

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.
Back in June I wrote about the Future of Drug Print Ads and pointed out that the "fair balance" information was atrocious -- pages of teeny-weeny type, impossible to understand, and inadequate as far as presenting side affect and other information about drugs to consumers. I noted that this fair balance is often the entire professional package insert (PI) verbatim.

It turns out that there is a good reason why the package insert is unreadable -- legal departments want the PI to stand as protection against product-liability lawsuits according to recent
Wall Street Journal article (see "Liability Worries Cloud Drug Labels").

The WSJ article confirms what I have already contended -- "It can be a struggle to find a useful nugget in the sea of fine print accompanying most drugs."
"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."
Cutback in TV Drug Advertising

Back in May there were a few signs indicating that drug companies were cutting back on TV ad spending (see "Pull Back from DTC on TV?"). It now appears that what was then feared has come to fruition.

According to USA Today "Drugmakers cut spending on network TV advertising by 10% in the first quarter from the year before, the sharpest quarterly fall-off in two years." (see "
Drugmakers cut back on television ad spending").
"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."
Many in the industry now admit that 60-second TV ads are not ideal for adequately conveying drug benefits and risks and other information necessary to truly educate the consumer.

Friday, July 08, 2005

Indication Bloat - The Next DTC Issue

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)."
Terry, a pharmaceutical marketer from the U.S., had this comeback and was the first to suggest a greater focus on disease state awareness advertising:
"“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."
[There seems to be a trend towards more emphasis on "disease awareness"” advertising -- or more euphemistically called "communications" -- as opposed to product ads by the pharmaceutical industry. BMS, for example, in its "Direct-to-Consumer Communications Code", pledged to "Develop disease state awareness advertising, as appropriate, for diseases that may be potentially treated by our newly launched medications in order to further educate consumers and healthcare professionals."

I think this is all well and good but I am also concerned that "“disease state awareness"” (DSA) ads may not be as politically correct as many people assume. One issue is who defines the “disease” and, by extension, how many people actually have the disease?

This issue was addressed in a recent Seattle Times article, "The hidden big business behind your doctor's diagnosis." I also have discussed this in relation to the erectile dysfunction (ED) market (see, for example, "“Pushing the Envelope is Bad for DTC"”). The drug industry has defined ED so liberally that they claim more than half of men over the age of 40 suffer from ED. "About 30 million men in the United States have difficulty getting or maintaining an erection," claims the disease information section of the Viagra website.

According to the National Institute of Diabetes and Digestive and Kidney Diseases, "...defining ED and estimating its incidence [is] difficult. Estimates range from 15 million to 30 million, depending on the definition used. According to the National Ambulatory Medical Care Survey (NAMCS), for every 1,000 men in the United States, 7.7 physician office visits were made for ED in 1985. By 1999, that rate had nearly tripled to 22.3."

Some might say that this increase in office visits is due to DTC, which made more men aware of the disease and encouraged them to seek treatment. Others might say that the DTC ads do not educate about the disease, but encourage men of all ages to seek ED drugs so that "If a playful moment turns into the right moment, you can be ready."” Hardly an appropriate disease awareness tagline, yet an example of what DSA ads might ultimately become if there were no DTC product ads!]

Abuzer, a consultant working for a pharma company, essentially agrees that it is the message rather than the medium:
"The ideal world, which we are far from but want to move towards, in my eyes is not the one without any DTC but the one where the best of DTC is sustained. It's about informing the patients not deceiving them, encouraging patient-doctor dialogue about that product rather than patients blind demand for it."
No DTC: Even Less Risk Information?
Sanjay, a longtime member of the group, worries that the risk information "“baby" contained in DTC ads would be thrown out with the "bath water" if DTC were banned:
"“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."
Kathy, another consultant, defended DTC on the basis that it helps brings proper treatment to the undiagnosed:
"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."
[This presumes, of course, that once in the doc's office, these people will get a proper diagnosis and appropriate treatment. I'’ve already covered this topic somewhat: See "Blame the Doc, Not DTC!"”]

David, from an interactive agency that creates a lot of pharmaceutical web sites, suggested a thought experiment: "“Let's assume there is no DTC advertising. So, your only source of information about treatment options is the trusted word of your personal physician."
"But wait," said David. "Vitamins can advertise. Supplements can advertise. Nutraceuticals can advertise. And, these therapies look so professional and clinical on the Internet. One of my colleagues calls them 'Pretender Marketing.'’ And, funny enough, you can order them directly from these very pharma-looking web sites."”
David claims that physicians would know less about the effectiveness of these alternative treatments than they do about FDA-regulated drugs thanks to the pharmaceutical industry. "So, in this thought experiment the lack of DTC drives more people to be open to heavily marketing '‘therapies' not under the jurisdiction of the FDA. The cat is out of the bag. Pandora's box is open. The physician has lost exclusivity.
"Now I'm certainly not saying that this justifies DTC - I'm only illuminating another facet. I would be happy to discuss whether all these ads are duping the 'gullible masses' but at least we're talking about MEDICINE here and not quackery. At least physicians know how to decide about pharmaceuticals."
[Hmmm... see my remarks above about docs.]

Brian retorted:
"“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)."
[What would DSA ads produced by the makers of ED treatments look like? First, as I mentioned above, there might be a tendency to overstate the frequency of the condition, especially among men under the age of 60. The DSAs would also have to be more sexually explicit and define what erectile dysfunction is. There are many definitions out there and I am sure marketers will tend to use the most liberal.

I see this kind of "“indication bloat"” as the next big issue that pharma marketers will have to defend. The problem is exacerbated by the fact that the FDA does not regulate DSA ads. Therefore, what's to stop "indication bloat" of the type that broadens the definition of a disease to include many more people than is actually justified by medical evidence and guidelines?]

Wednesday, July 06, 2005

Deconstructing Frist on DTC

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."]
Those are taglines for some of America’s best-selling, most widely advertised prescription drugs in recent years. We all know them because we’ve heard them over … and over … and over again.

We are barraged with them.
[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?"]
We’ve heard them on the television set and our favorite radio programs. We’ve read them in newspapers and weekly magazines. We’ve seen them on billboards along the highway and, yes, even on stock cars at our favorite racetracks.
[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"]
This is called “direct-to-consumer” advertising. It’s when drug companies market their products -- over the heads of doctors -- directly to patients and prospective customers.
[I object to the phrase "over the heads of doctors." It makes it sound like doctors unanimously oppose these ads.]
Now obviously there can be some health education benefits to such advertising. But let there be no mistake: drug advertisements fuel America’s skyrocketing prescription drug costs.
[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.]
They influence consumer behavior. And they influence physician behavior.

They cause more people to take prescription drugs. They create an artificial demand. And they drive up our nation’s overall health care costs. They needlessly and wastefully rive up your health costs.

Moreover, a lot of direct-to-consumer advertising misleads patients. It may oversell results. Or it may undersell the risks. Either way, misleading drug advertising hurts patients and definitely pressures doctors to over prescribe.
[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.]
Today I urge all pharmaceutical companies to voluntarily restrict consumer drug advertising during the first two years that a new drug is on the market. Today I’m also requesting a government study of the costs, consequences and any potential benefits of direct-to-consumer advertising.
[A government study is always a good way to keep your name in the news or at least revisit the issue again and again.]
It’s time for drug companies to clean up their act. If they don’t, Congress will.
[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.]
In its proper place, direct-to consumer drug advertising can empower consumers. It can give them information they need to make informed, smart decisions about their health. It can inform them about new therapies. These are good things.

Indeed, America needs a patient-centered health care system. Timely, accurate, complete, and balanced information must be a pillar of any such system. And advertising can help provide this information. But right now it simply is not.
[I'd have to agree with Frist on this point. See, for example, "Is DTC Educational or Motivational?"]
Today’s advertising leaves parents more often having to explain to their 10-year old children what erectile dysfunction is than how to prevent and treat high blood pressure.
[See what I mean about those ED ads being too good a target to pass up?]
So how did we get to this point?

Well, prior to the early 1980s, drug manufacturers almost always explained and introduced their products directly to physicians. Then, in 1981, Boots Pharmaceuticals ran the first U.S. print advertisement directed to consumers for its ibuprofen product, Rufen.

By the 1990s, drug companies began to use more print advertisements to promote their products directly to consumers. But they ran television advertisements only sparingly.

Since 1962, the FDA has required ads to include a brief summary of a drug’s side effects, indications for use, contraindications, warnings, and precautions. Massive changes began, however, when the Clinton administration liberalized the disclosure rules for televised ads in 1997.
[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.]
Rather than providing a full picture of a drugs’ risks and benefits, the new laws required only that drug companies disclose the most significant risks and refer patients to a secondary source of information.
[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?"]
As a direct result of the 1997 ruling, spending on direct-to-consumer advertising skyrocketed 145 percent between 1997 and 2001. It passed the $1 billion mark in 1997 and reached $2.7 billion by 2001.

In comparison, spending on pharmaceutical research and development increased by only 59 percent during this same period. Last year, pharmaceutical companies spent over $4 billion advertising medications directly to consumers.

Why? Because advertising sells drugs.

I believe the Clinton administration -- under intense pressure from the drug industry -- opened the door too widely. As a result, direct-to-consumer advertising exploded to levels that many could not have anticipated. And this has driven up prescription drug use and spending and, I believe, led to inappropriate physician prescribing.
[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").]
Consider the recent labeling changes and market withdrawals of non-steroidal anti-inflammatory drugs. These were among the most heavily advertised drugs in America. They were used by millions of patients. And many believe they may have been over prescribed.

In the case of Vioxx, 93 million prescriptions had been written since its approval in May 1999. And millions of prescriptions were also written for similar drugs, such as Celebrex and Bextra.

In the case of Vioxx, it did prove better than competing products for patients with stomach or gastrointestinal problems. Merck did conduct additional post-market research not required by the Food and Drug Administration. And, of course, we cannot foresee every risk.
[But the real issue here was not the risk vs benefit profile of the drug, but Merck's alledged obstructionism and attempts at damage control, doing all it could to divert attention away from the risk data while continuing to agrressively sell the drug. See, for example, "Who Should Pay for Merck's Obstructionism?" and "Get a Load of Those Gams".]
But, quite simply, we should always strive to make safety our top concern, particularly for newly-approved products used for the very first time in millions of patients. And doctors should have more time and more complete, balanced information to weigh the risks and benefits of a product.

In a 2002 report on the practice, the Government Accountability Office highlighted two studies. Each showed that a 10 percent increase in DTC spending within a drug class increased sales in that class by 1 percent. For one popular, heavily advertised prescription drug, one dollar of consumer advertising translated into four dollars in increased sales.
[This ROI estimate may be a tad high. For other estimates, see "eDetailing ROI Better Than DTC?"]
No wonder the drug companies flood our airways.

The GAO’s findings were clear: increased direct-to-consumer advertising has helped fuel escalating drug costs.
[I haven't read this report, but I'll give you my opinion anyway. The Summary of the report contends that there is a link between heavily advertised drugs and sales of those drugs. It doesn't provide evidence for a cause and effect link to prove that DTC helps "fuel" escalating drug costs. I think drug company shareholders and their Wall Street analysts are really the high-octane fuel behind rising drug costs. Nobody would consider banning selling drug company shares for 2 years!]
Drug costs are skyrocketing. In 2003, Americans consumed 134 billion prescription pills and spent over $216 billion on prescription drugs. This is as much as Americans spent on gasoline and oil. During the past few years, drug costs have gone up more than twice as fast as inflation-- faster than nearly all other health care items and services.
[An interesting statistic. If we pop over to the oil industry lobbyists, I am sure they could cite a statistic that Americans spend more on a gallon of bottled water than on a gallon of gasoline. From which one might say that we spend more on water than on drugs, and ergo, drugs are less expensive than water! What a bargain!]
Congress paid attention. And we acted. In 2003, we passed the Medicare Modernization Act. With President Bush, we took major steps toward providing more affordable prescription drugs:
[The following is the pitch for Bush. Let's just skip over that, OK?]
Congress took a good step in the right direction. But we clearly have more to do. And, as part of this effort, we must take a closer look at prescription drug advertising. Unbalanced and misleading prescription drug advertising hurts people. It adds tension to the physician-patient relationship. It leads to inappropriate prescribing. And it overwhelms our current regulatory system.

Let me begin with consumers. We are all too familiar with these ads. They adorn the pages of major magazines, websites, and newspapers. They flood the airwaves. And, particularly on television, they present a parade of upbeat images, but offer warnings and cautions only as an afterthought.

Just think, how many parents have found themselves watching a sporting event with their son or daughter only to be assaulted by an ad for an erectile dysfunction drug? Advertising during last year’s Superbowl comes to mind.
[Back again to the ED ads. I'm beginning to think Frist is a bit obsessed with these ads. I also have written about them to expose how they are hurting the DTC cause. See, for example, "Super Bowl DTC Debut: Was It Good for You?" and "Marketing Drugs Like Packaged Goods at the Super Bowl"]
Also, only rarely do these ads provide consumers with enough time to absorb important risk information.

According to a 2002 FDA survey, nearly 60 percent of patients reported that drug advertisements don’t provide enough risk information. And 58 percent of patients felt that ads portray products as better than they are.

In a separate 2002 FDA survey, 75 percent of physicians said that ads led patients to overestimate the efficacy of the drugs. And 65 percent of physicians noted that patients confuse the risks and benefits of drugs advertised to consumers.
[The study also showed that DTC advertising, when done correctly, can serve positive public health functions such as increasing patient awareness of diseases that can be treated, and prompting thoughtful discussions with physicians that result in needed treatments being prescribed - often not the treatment in the DTC advertisement. This study also demonstrates that most physicians view DTC advertisements as one of many factors that affect their practice and their interactions with patients, both positively and, in some respects, negatively. See "Results from FDA Physician Survey on DTC Advertising".]
This means that sometimes a patient may request or even insist upon a drug that does more harm than good. They may rely too heavily on a pill when overall lifestyle changes are called for. They may demand the latest, expensive medication when an old standby may do just as well.

And patients, seeing the ads, place new demands on their doctors. My medical colleagues are pressed for time. Driven by the drumbeat of advertising, relentless pressure to contain costs, and the understandable desire to please their patients, some harried physicians write unneeded prescriptions rather than arguing with their patients or explaining why a less expensive drug would be just as effective.
[Shame on them, I say. See "Blame the Doc, Not DTC!"]
As example -- after one year of directly advertising the bone-mass-increasing drug Fosamax to consumers, physician visits for osteoporosis evaluation nearly doubled.

This is a good example of why direct-to-consumer advertising is a double-edged sword: Those additional visits indeed helped some find needed treatment, but did these ads provide patients with useful information when discussing it with a physician?

In a recent study from the University of California-Davis, researchers sent actors in good health to 152 doctors’ offices in three cities to find out if they could get prescriptions for simulated symptoms. Half of the actors imitated patients suffering from depression. The other half expressed symptoms of stress and fatigue.

The study found that if an actor requested Paxil, a heavily promoted antidepressant, he was five times as likely to walk out of the doctor’s office with a prescription for the drug. The research suggested that direct-to-consumer advertising increases patient demand for specific medications, even in situations where the prescriptions aren’t needed.
[I have a problem blaming DTC for poor medical practice, which is what I think this study really reveals. See "Blame the Doc, Not DTC"]
Finally, we need to ask questions about how we regulate prescription drug advertising. Right now, the FDA has neither the resources to scrutinize direct-to-consumer drug advertisements nor the power to review them for accuracy before they are viewed by the American public.
[The Bush administration has to accept some responsibility for this, in my opinion.]

The FDA simple can’t keep up. And our failure – our government’s failure -- to appropriately regulate drug advertising hurts the very people drugs are intended to help -- patients. We are not serving the American people as well as we should – or can.

Two weeks ago, the pharmaceutical company Bristol-Myers Squibb announced a voluntary ban on advertising its new drugs to consumers in their first year on the market. The company said it wanted to give doctors more time to understand new products before patients start asking for them.
[See "New DTC Principles Emerging" for more on this.]
This shows leadership and responsibility. Bristol-Myers Squibb sets an example of restraint in an industry that needs it more than ever when it comes to advertising.

But this cooling off period may not be enough. PhRMA, the drug industry’s trade association, has announced it will adopt an industry-wide voluntary code governing direct-to-consumer advertising next month. This is another good move.

I believe this should, at a minimum, include a voluntary restriction on the direct-to-consumer advertising of prescription drugs in their first two years on the market.

Why this restraint? A typical clinical trial for a drug includes roughly 5,000 patients. A blockbuster drug can attract more than a million users during its first year on the market. But no drug is free of side effects. It often takes years before scientists get a complete picture of a new drug’s effects.

Both doctors and patients need time to learn about new treatments, assess their benefits, and find out more about their risks. A full knowledge base of the potential side effects takes time to develop. Education should always come before persuasion. Patient safety should be paramount, not the bottom line.
[Frisk sounds positively populist here -- well beyond liberal even. Will the pharma industry and its representatives now accuse Frisk of being against free enterprise? Perhaps this is another example of "creating a war of 'liberal idealism' versus 'profit hungry big business' " See "Separation of Church and State."]
If these voluntary restrictions don’t do the job, I believe Congress should act.
[Look out for a pre-emptive first strike!]
Three additional steps should be considered. Some may require legislation. Others could happen through voluntary work by the drug industry – which I would encourage.

First, we should give the FDA prior review and approval authority for all direct-to-consumer drug advertising.

By the time the FDA reprimands a company for running a misleading drug commercial, that advertisement may have already deceived consumers. Advertising should boldly and responsibly address safety head-on, replacing upbeat, fantasy-land images with a frank discussion of a product’s benefits and risks.
[For an idea of how the industry can do this, see "DTC Straight Talk," which discusses a J&J approach.]
Second, we should increase resources devoted to reviewing advertising to determine its accuracy and to ensure all standards are met.

The FDA – to whom we have given this responsibility -- must have the capability and resources to more thoroughly monitor drug advertising and make absolutely sure that companies comply with advertising guidelines.

The American people assume this is being done – and it is not.

A staff of 40 simply isn’t enough to get the job done. We should explore ways to make sure that adequate resources are devoted to this problem, so the FDA may appropriately and adequately act before a misleading advertisement influences the behavior and health decisions of the consumer.

Third, we should give doctors and patients greater access to clinical data and post marketing surveillance efforts about drugs after they become available.
[See, for example, "Proposal for a Drug Risk Advisory System"]
For the drug industry which has long touted the educational mission of its ads, it must know that the success of their mission inherently depends on the quality of information provided to physicians and patients – not just the enticing images.

While we can’t foresee every risk, the industry has a responsibility to provide physicians and patients with balanced information regarding a drug’s risks and benefits.

As a doctor who has witnessed both the good, but especially the bad, in this explosion of drug advertising, 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.

In the meantime, today I’m asking the Government Accountability Office (GAO) to investigate the FDA’s oversight of prescription drug advertising, the pharmaceutical industry’s spending on such advertising, and this advertising’s impact on utilization, health care spending, and patient education and awareness.

Wherever I travel -- whether I’m at the Coca Cola 600 in North Carolina or at Harvard Medical School in a roundtable discussion with doctors -- people ask me about health care costs and access to affordable, quality care. They come back again and again to the pitfalls and the loss of direction of DTC advertising.

I believe that we must move towards a health care system that puts the patient at the center and in control. And, above all, one that controls costs for the American people.

I know my colleagues share these same priorities. I believe the steps I propose will save money. But, even more importantly, they will save lives.

Prescription drugs rank among the most powerful tools in medicine. We could not and should not do without them. But we must use them—and market them—with care.
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