Insomnia - the Next DTC Frontier

You've probably seen ads on TV and in print for several new drugs to treat insomnia. FDA-approved drugs for this condition include AMBIEN (Sanofi-Aventis), LUNESTA (Sepracor), SONATA (King Pharmaceuticals), and ROZEREM (Takeda).

As the competition for market share heats up, you can expect to see these brands push the DTC advertising "envelope" the same way that erectile dysfunction (ED) drug ads did. What I am talking about is:

Indication Bloat -- the tendency to inflate the estimated number of people that suffer from the drug's indicated condition. I have written on this topic before, using ED as a case study (see "Indication Bloat - The Next DTC Issue"). Like ED, insomnia may be difficult to define and most ads I've seen hardly mention insomnia at all. Instead, the ads use phrases like "Trouble Sleeping?" or "Tossing & Turning?" Here's some numbers you might hear:

An estimated 126 million adult Americans experience at least one insomnia symptom a few nights a week, according to the National Sleep Foundation, a group which receives some of its funding from drug companies. Only about a third of sufferers are actually diagnosed with insomnia, and a small fraction of those are treated with prescription medication. ("Ad war looms in crowded sleep aid market"; Boston Globe, July 19, 2005)

Lack of Disease Awareness Education -- Indication bloat is aided and abetted by a lack of any educational content in DTC advertising. After all, the more consumers are educated, the less likely that they will fall victim to the indication bloat ploy. While the web sites for these "sleep aids" offer decent disease education (you might need to use the "site map" function to find this stuff), the TV ads don't have much meat in that department. There's also no mention of other, non-drug, treatments for insomnia.

Glossing Over Important Side Effects -- Most of the "sleep aid" medications, like all drugs, have side effects. How fair is the balance in the ads for these drugs when the side effects are mentioned in a relaxing tone of voice over images of a relaxed sleeping beauty?

Making Claims That Are Not Supported in the Drug's Labeling -- Some physicians are miffed at LUNESTA ads that claim the drug is approved for long-term use whereas the label does not specifically say that. According to an article in the August 18, 2005 issue of the Boston Globe: "[The FDA approved label] does not mention how long the pills can safely be taken. The FDA did not require the label to specify that the drug is for ''short-term" use, as it has for other prescription sleep aids on the market."

PhRMA Code Litmus Test
One of PhRMA's new DTC guidelines states: "DTC television advertising that identifies a product by name should clearly state the health conditions for which the medicine is approved and the major risks associated with the medicine being advertised." This would effectively put an end to reminder ads (see "Reminder Ads - Pharma's Dodo?").

I am keeping unofficial tabs on compliance with these guidelines and have already mentioned a case where a drug company may be in violation (see "After School Cialis Ads").

Yesterday, I saw reminder ad for LUNESTA on TV even though Sepracor announced nearly two months ago that it will abide by PhRMA's voluntary guidelines. I guess this is another case of running ads that were already purchased, which I find a poor excuse.

What Does Trust Mean?
Pharma companies want to improve their image with consumers and have a trusting relationship with consumers. I would think that the most effective way to build trust would be to carry through on promises made. If you promise not to run reminder ads, for example, then don't run them. Duh!

FDA May Follow PhRMA's Lead on DTC

In November, the FDA will host a 2-day public meeting on direct-to-consumer (DTC) promotion of regulated products, including prescription drugs. According to the September 13, 2005 Federal Register notice, the FDA is interested in hearing opinions on a number of topics relating to DTC. This hearing promises to be a prelude to new FDA rules governing DTC.

From the look of the questions the FDA is seeking comments on, I'd say any new FDA rules are likely to be very similar to the voluntary guidelines announced by PhRMA in August (see "PhRMA Finalizes DTC Principles"). If so, this would be a case of the hen leading the fox and would represent a victory for the pharmaceutical industry, which was criticized for not going far enough to reign in DTC advertising.

Or, you may look at it another way: it's always unwise to propose meaningful voluntary guidelines because it's likely to end up as mandatory government regulations. This may be why PhRMA was reluctant to go further with its guidelines and especially why the guidelines did not include a DTC moratorium period following a drug's launch.

Whatever! The important thing is to see what exactly is on the table that might lead to further regulations. The following are excerpts from the FDA's notice -- with commentary, of course, to put things in [my] perspective and give you some more background information.

Likely to Lead to New DTC Regulations
According to the notice "FDA is particularly interested in hearing the views and comments from the public as to whether, and if so how, the agency's current regulations and the agency's interpretation of those regulations and actions under them should be modified to better address consumer-directed promotion of regulated products. FDA is holding this hearing because it believes the agency, the industry, and other members of the public now have enough experience with DTC promotion to understand what regulatory issues may need to be addressed in new FDA activities."

These "new activities" may focus on the following issues:

DTC Education
The pharmaceutical industry contends that DTC is educational. Hank McKinnell, CEO of Pfizer, for example, prefers to call pharma ads to consumers "DTC Education" (see "A Call to Action: A Mea Non Culpa by Big Pharma"). Johnson & Johnson Chief Executive William Weldon said in an address to PhRMA: "Our communication with patients should really be thought of as Direct to Consumer Education” (see "DTC Straight Talk").

FDA is not so sure about the educational merit of DTC...

Disease Awareness Education
FDA wants to know if DTC needs additional educational content about the disease or condition. "FDA is ... specifically interested in whether paying greater attention to the educational component of an advertisement (i.e., devoting more attention to defining the disease and its manifestations) would help consumers better understand the role drug and device therapy may play in treating that disease."

[HEN vs. FOX: PhRMA (the "FOX" in this case) has already addressed this in its guidelines: "Companies are encouraged to promote health and disease awareness as part of their DTC advertising."

Individual drug companies have gone further. Pfizer, for example, pledges in 2006 to "invest a meaningful amount -- on par with what it spends on a branded advertisement campaign" to create non-branded ads such as disease-awareness ads and compliance ads.]

Reminder Ads
FDA asks: "What is the potential role of reminder ads in all types of consumer promotion, such as broadcast, print, and the Internet?"

[HEN vs. FOX: PhRMA essentially pre-empted this concern in its principle 10: "DTC television advertising that identifies a product by name should clearly state the health conditions for which the medicine is approved and the major risks associated with the medicine being advertised."

For more on this, see "Reminder Ads - Pharma's Dodo?"

However, FDA didn't limit its concern just to television advertising and wants to include the Internet as well. I am not sure how much reminder ads are being run on the Internet, but the whole issue of DTC on the Internet needs closer inspection, IMHO.]

Risk Communication
The FDA has done some research on patient and physician views of DTC (see, for example, "Results from FDA Physician Survey on DTC Advertising" and the 2004 final report on these surveys) and "is interested in hearing why consumers and healthcare providers may believe that risk information is not being communicated as clearly as benefit information, even though that information is present."

[HEN vs. FOX: Nobody seems to have a good idea why risk information is not communicated well to consumers. Pfizer, for example, says it is studying how to do this better.

For more on this, see "Can Drug Ads Communicate Risk?"

Meanwhile PhRMA principle 11 states: "DTC television and print advertising should be designed to achieve a balanced presentation of both the benefits and the risks associated with the advertised prescription medicine. Specifically, risks and safety information in DTC television advertising should be presented in clear, understandable language, without distraction from the content, and in a manner that supports the responsible dialogue between patients and health care professionals."]

The FDA asks: "How could the content and format of risk information in promotional pieces be better communicated to consumers? Because consumers sometimes lack advanced medical knowledge, how can FDA help ensure that those consumers who are not medical experts understand a product's risks?"

The agency is concerned about the context as well as the content regarding communication of risk in DTC: "ad[s] may continue to present positive scenes of individuals enjoying the benefits of the advertised product during the presentation of risk information, which is usually presented separately from the benefit information. Do such common advertising techniques create barriers to consumers' understanding of risk information?"

[There are alternatives to the "common advertising techniques" often used to gloss over risk information. News ads by J&J which, for example, put drug risk on a more-equal footing with drug benefits. See "DTC Straight Talk".]

Coupons, Free Trials, and Money-Back Guarantees
FDA raises a concern about using certain promotional techniques for drugs and devices that have been "imported" from other industries (e.g., packaged goods).

"Some companies offer consumers coupons, free samples, free trials, and money-back guarantees for prescription drugs in both full-product as well as reminder advertisements (which do not inform the consumer about the benefits or risks associated with the product). Are these approaches appropriate ways to influence consumers?"

[This issue was not addressed in any of the voluntary DTC industry guidelines that I have seen. I expect that the industry will defend these tactics as valid and even claim that they are helpful in lowering the costs of drugs.]

Celebrity Spokepersons and Actors Portraying Docs
FDA: "Another standard marketing technique uses real people, or actors portrayed as real people, to provide positive reports (testimonials) about an advertised product. Applied to medical products, this technique portrays patients who describe how a drug or device helped them manage their medical condition. In rarer instances, healthcare providers, or actors portraying them, vouch for the use of the product. Such approaches plainly do not reflect a data-oriented approach to promotion and may not be recognized by consumers as anecdotes. FDA is interested in whether and how techniques mislead consumers about the risk-benefit tradeoffs of prescription or restricted medical products."

[Again, the industry's voluntary guidelines do not address this issue. The DTC straight talk ads of J&J, however, use real physicians, which seems more honest. I haven't noticed a "Not a Real Doctor" notice on DTC ads that use actors portraying doctors. You know, like the "Professional driver on closed track" notices in car commercials.]

Comparative Ads
FDA: "Promotion that compares one product to another or to several others is becoming more common in DTC promotion. Given that this information is often scientific or numerical in nature, how can companies convey this information in a way that is informative to consumers without advanced education, and how well are companies currently doing this?"

Package Insert
FDA: "For promotional labeling, is the current package insert the best way to meet the requirement to bear adequate directions for use in consumer-directed materials? Are there ways to modify the content, format, and language of the package insert that would make this information more easily understood by consumers?"

For more on why package inserts aretrulyl inadequate, see "Future of Drug Print Ads".

DTC and New Communications Technologies
The FDA has never developed specific regulations for drug promotions via the Internet despite holding public meetings on the topic. At the upcoming November meeting, it appears that they will once again consider if new communications technologies require special treatment.

FDA: "As new communication technologies emerge, they create opportunities for novel approaches to DTC promotion. What issues should the agency consider with regard to the effect of these technologies on DTC promotion?"

"FDA research has shown great increases in the number of people who now use the Internet to search for information about prescription drugs. Drug companies produce video news releases, audio news releases, and print "advertorials," which are disseminated to TV and radio stations. At times, TV and radio stations do not make it clear to consumers that such promotional pieces are generated by regulated industry. The agency is interested in hearing the public's views on these promotional techniques and the issues they raise."

Once again, FDA seems to be firmly planted in the past. There are new communication tools such as blogs, RSS, etc. that the industry will surely experiment with to generate "buzz" which will not be labeled as paid promotion. For more on this, see "Buzz is NOT regulated by FDA".

I should reveal that I am involved in helping the pharma industry get up to speed on using novel communication tools such as blogs. For example, I will be the Chairperson and speaker at the first conference devoted to pharmaceutical blogging (see PharmaBlogging Conference information on Pharma Marketing Network).

Vioxx Hex or Hoax?

The Washington post published an editorial favoring legislation to shield drug companies from punitive damages in lawsuits like the those currently faced by Merck. Here's the main thrust of the Post's argument:

Politicians and regulators should be asking themselves whether a system of massive cash awards to people who may or may not have been adversely affected by Vioxx is a logical, fair or efficient way to run a drug regulatory system. They should also be asking whether juries that scorn medical evidence are the right judges of what information should or should not have been on a prescription label.

The first principle of reforming this system should be that a company that follows the FDA's rather extensive guidelines should be protected from punitive, if not compensatory, damages. At the very least, it is time for Congress to start considering whether a model such as the one set up for children's vaccines -- in which a fund is set up to cover the costs incurred by children harmed by vaccines -- should be constructed for all drugs.

See "The Vioxx Hex" (Washintong Post, 9/16/2005).

You might have expected something like this from a right-wing think tank like the American Enterprise Institute (see, for example, "Saving Public Merck"), but from the Washington Post?! You should read the comments from some intelligent people about whether and how Merck should be saved by Congress (ibid).

The editorial suggested that the jury "scorned medical evidence." This is the hoax perpetrated by this editorial! More likely the jury did not understand the science. Here's the case I make in this month's issue of Pharma Marketing News:

My oldest son recently started as a freshman at Penn State and I miss him a lot. The first email message I sent him was intended to encourage him to stick with engineering and science. "“When you consider your major and your future,"” I wrote, "“keep in mind that the sciences and engineering will put you among the technical elite in this country. That means big rewards! Also, given your ability to get along with people, your mom and I have no doubt that you will do well in business and in life. So, good luck and keep up the good work."”

The "“technical elite"” class of people I referred to in my email is a dwindling national asset. While the SAT math scores of U.S. high school seniors increased somewhat this past year (my son scored a 780!), the U.S. is still, I believe, just one notch ahead of Latvia. Added to that are our leaders who suggest that there is an alternative theory to evolution that should be taught in our science classrooms!

Is it any wonder, therefore, that jurors who voted against Merck in the first Vioxx liability case said much of the science sailed right over their heads?

Or could it be that the Merck witnesses did not know how to explain the science? (See Merck science "like wah, wah, wah").

There is no doubt that the industry needs to do a much better job communicating drug benefits and risks to consumers. How will they do this if the population at large is scientifically illiterate?

Also, how can the drug industry focus on this problem if its leaders are not grounded in science?

Take, for example, the current CEO of Merck, Richard T. Clark. He is an operations guy, who promises to bring efficiency, not scientific glory back to Merck. As described in the Wall Street Journal at the time he was named CEO, Clark is "an insider without a background in medicine at a time when observers agree that the company desperately needs to focus on developing new drugs. Moreover, Merck made its selection even after its glory faded under a previous nondoctor, Ray Gilmartin."

At the recent Pharmaceutical Marketing Congress I met Roy Vagelos, M.D., former Chairman and CEO of Merck, who gave a keynote presentation entitled "Medicine, Science, and Merck: The Changing Pharmaceutical Industry."

Vagelos told the story of how Merck science and leadership was responsible for some of the greatest drugs ever developed. As Dr. Vagelos went through his presentation, I felt that I was in the presence of a dying or already dead breed of pharmaceutical executive -- —an executive with a passion for and a deep understanding of science. He also did a great job explaining the science and making it sound exciting!

It's difficult to imagine Merck employees feeling excited about their company today, especially with years and years of Vioxx-related litigation to look forward to ("We are in this for the long haul," Merck general counsel Kenneth Frazier said).

I mentioned this to Dr. Vagelos as he signed a copy of his book, "Medicine, Science, and Merck." He nodded his head and looked sad as he wrote the inscription: "Good luck - keep up the good work."

The WP editorial also said that the Vioxx label "did warn of coronary side effects." Ha! Whenever someone mentions "drug label" I take out my pistol! See, for example, "Labeling / TV DTC Revisited."

I could go on, but it's the weekend. See you next week!

Vagelos Speaks, Will Pharma Listen?

Roy Vagelos, Former Chairman and CEO of Merck, gave a keynote presentation at the Pharmaceutical Marketing Congress in Philadelphia this past Tuesday. His presentation was entitled "Medicine, Science, and Merck: The Changing Pharmaceutical Industry."

Vagelos began his career as a physician and medical researcher. At Merck, he was also head of research before being "promoted" to CEO.

Dr. Vagelos made many interesting points that I'd like to summarize in this Blog and in a future issue of Pharma Marketing News. Topics Vagelos addressed were science, credibility, pricing, and the future of the pharmaceutical industry.

Science
Vagelos told a story of how Merck science and leadership was responsible for some of the greatest drugs ever developed. As Dr. Vagelos went through his presentation, I felt that I was in the presence of a dying or already dead breed of pharmaceutical executive -- an executive with a passion for and a deep understanding of science.

In all the hubbub back in March when Merck was looking for a new CEO, no one expressed much interest in the job. I even turned them down (see John Mack Rebuffs MerckÂ’s CEO Offer). The candidates that Merck considered for the job came form the "suit side" of the business, not from the science side as Vagelos did.

The current CEO of Merck, Richard T. Clark, is an operations guy, who promises to bring efficiency, not scientific glory back to Merck. As described in the Wall Street Journal at the time, Clark is "an insider without a background in medicine at a time when observers agree that the company desperately needs to focus on developing new drugs. Moreover, Merck made its selection even after its glory faded under a previous nondoctor, Ray Gilmartin."

No wonder that Merck cannot even explain its own science (see Merck science "like wah, wah, wah").

So, it was very refreshing and uplifting to hear the personal story of an "“old-time" pharma leader who came up from the ranks on the research side of the business. After hearing about Vagelos' personal experience at Merck and his opinions about the future of the industry (he said, for example, that research inside big pharma companies will "atrophy to some degree"), it may be time for PhRMA, the industry trade group, to drop "Research" from its name!

Credibility
According to Vagelos, the pharmaceutical industry is undergoing a revolution. He cited, first, the drop in the public image of the industry as noted in a 2004 Harris poll. In that poll, conducted in April 2004, respondents were asked "Do you think [the following industries] generally do a good or bad job serving their consumers?" Pharmaceutical and drug companies ranked near the bottom along with oil companies and tobacco companies. Less than half (44%) of respondents answered "Yes" to the question as applied to the drug industry. In the 2005 Harris poll, that number increased to 56%, but the trend is still downward (see CHART).




If the trend continues, within 3 years pharma companies will have as little respect from consumers as do tobacco companies! Quite ironic considering that one industry's mission is to improve lives and the other is to addict people to life-threatening products! Can you guess which is which?

Pricing
According to Harris, concerns about prices are clearly the reasons for the decline in the ratings of oil companies and pharmaceutical companies.

Vagelos described Merck's pricing strategy, which is (was?) based on "value": the value that drugs have in keeping people alive, out of hospitals, keeping them at work, and quality of life improvement. Competition, of course, is another factor to consider when pricing a product.

Most drugs on the market, said Vagelos, 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."

Back in 1990, when 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." You only have to look at data cited by the AARP, which tracks drug prices versus CPI, to see that this is true:

New data analyzed by the AARP Public Policy Institute show that over the 12-month period ending March 2005, manufacturers raised the price they charge for 195 brand-name drugs most commonly used by older Americans, on average, by more than 6 percenpercentpercent). By contrast, over the same period, manufacturers raised the list price of 75 most commonly used generic drugs, on average, by less than 1 (0.7) percent. The general inflation rate, as measured by the Consumer Price Index (CPI), averaged 3 percent during the same period. (See "Average Price Increase of Brand-Name Drugs More Than Doubles CPI").

What Do You Get Out of Doing Good?
Vagelos recounted Merck's contribution to world health through programs that offered drugs free in developing nations. Vagelos and Merck thought this was good to do for a company dedicated to health.

It also was very good for the morale of Merck employees. "The people at Merck," Vagelos said, "were very excited that Merck would do such a thing. At that time and for more than a decade afterward, Merck was able to recruit anybody to any part of the company they wanted. It made it such an attractive company!"

It's difficult to imagine Merck employees feeling excited about their company today, especially with years and years of Vioxx-related litigation to look forward to ("We are in this for the long haul," Merck general counsel Kenneth Frazier said. See "Merck vows to fight Vioxx suits").

I mentioned this to Dr. Vagelos as he signed a copy of his book, "Medicine, Science, and Merck." He nodded his head and looked sad as he wrote the inscription: "Good luck - keep up the good work."

Preview of September Issue of Pharma Marleting News

Article Summaries

cDetailing: Addressing the Consumer Education Gap
Steve Smith, Editor-in-Chief of Medsite has reengineered his company's eDetailing line to create engaging interactions crafted around effective methods to engage, inform, and educate adults. Now he has tapped this experience to design the company's first Consumer Detailing ("cDetailing") product, which is a novel rich-media online consumer disease education and drug information program.

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The Evolving Impact of Anti-Spam Legislation on Online Marketers
In the last year the FTC has issued regulations that set forth additional requirements under the federal CAN-SPAM act that you should be aware of. Hilary M. Wandall, Esq., CIPP, Director, Corporate Legal/Merck Privacy Office, Merck & Co., Inc., summarized these regulations in a recent ePharma Summit Presentation in Atlantic City, NJ.

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Patient Detailing at the Point of Care
Return on DTC investment is decreasing and in the post-Vioxx marketing environment in which pharma marketers find themselves, there is a call for less advertising and more education. There are several new strategies and solutions available to pharmaceutical marketers that are designed to increase the education quotient of pharma marketing communications. One such solution is wireless Webpad developed by Phreesia for deployment in doctors' offices.

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Midwestern eMarketing Values
On the Internet it's still about content, content, content. Some may consider this old-fashioned. But Siren Interactive, a Midwestern interactive eMarketing firm, believes that valuable Internet content is a prime component to an effective eMarketing strategy for pharmaceutical companies.

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Pfizer No Longer Top 10 Advertiser

According to Nielsen Media Research data quoted in a recent MM&M News Brief,Pfizer fell from its position as one of the nation's top 10 advertisers as overall pharma industry ad spending slowed during the first half of 2005.

"Contributing to the overall decline in Pfizer spending was:

• A 98 percent drop in ad spending on Pfizer's painkiller Celebrex, brought about by safety questions concerning the COX-2 drug.
• An 85 percent drop in spending on ads for Zoloft following safety questions surrounding a link between antidepressants and suicidal thoughts in young people.
• A 43 percent reduction in spending on ads for Viagra following a call by the FDA for Pfizer to stop running television ads for the ED treatment last November."

The cutback in Viagra TV ad spending may also have to do with comments from critics such as myself and Congressional leader Bill Frist who specifically cited problems with airing ED drugs ads during sporting events and at other times when children might be watching TV (see, for example, "Deconstructing Frist on DTC").

An article in the Boston Globe reported that "advertising consultants and consumer advocates said it also could be due to a public backlash against companies that peddled erectile dysfunction drugs on television during the hours when children were watching and aggressive advertising that transformed Merck & Co.'s Vioxx into a blockbuster, despite the painkiller's heart risks."

On August 11, Pfizer promised to "Review the placement of our current advertising to ensure that it will be targeted to avoid audiences that are not age appropriate. For erectile dysfunction ads, this means that all TV ads will be aired during programs that have more than 90 percent adult viewership" (see "Pfizer DTC Pledge: ED is Litmus Test").

I have not seen many Viagra ads on TV these days and it may be that Pfizer has cut these out entirely. At least I haven't seen any Viagra ads on the after school ESPN show -- a seemingly fertile ground for Cialis and Enzyte ads (see "After School Cialis Ads" for more on that).

After School Cialis Ads

On August 2, 2005, Lilly announced its support of the Pharmaceutical Research and Manufacturers Association's (PhRMA) comprehensive guiding principles on consumer advertising of prescription medicines (see "Lilly Announces Support of Drug Industry Principles on Consumer Advertising of Prescription Medicines").

Lilly further stated that it planned " to take action to an even higher standard than the guiding principles." I.,e.

"The company, along with its partner ICOS Corporation, will limit the advertising of Cialis to programs when younger audiences are unlikely to be viewing. In doing so, the companies will commit to target programming with at least 90 percent adult viewers. Cialis television advertisements will not air during the broadcast of major sporting events, such as the Super Bowl and the Olympics, which are likely to draw large numbers of younger viewers. The companies will begin implementing these changes immediately, with full compliance within 60 days."

It all depends, however, on what Lilly means by "immediately" and "full compliance."

Last Thursday, my 15-year old son was sitting in front of the TV after school at 3 PM watching ESPN (or ESPN2, whatever) as he often does. From my nearby home office I heard "erectile dysfunction" and quickly ran in to see the end of a Cialis ad on the TV.

"Dad," said my son, "what's up?" [Pun intended] "You are obsessed with these drug ads!"

"It's my business to follow this stuff," I said. "The drug industry promised to follow rules to limit these types of ads to times when kids like you would not likely be watching."

"You mean they broke the law just now?" he asked.

I tried to explain within his attention span timeframe that, no, it wasn't a law but a voluntary agreement, which, if all drug companies obeyed, might prevent the government making a new law.

"Whatever," he said as he continued to watch the pre-season football analysis.

I was mildly surprised to see the Cialis ad at that time of the day. Will lilly claim that the ESPN audience at 3 PM on a weekday -- 20 minutes after the nation's male high school students return home from school -- is "90 percent adult?" What kind of male adult is home watching ESPN at 3 PM on a weekday? Probably a loser without a job who can't get it up! [Not me! I have a real job! Well, it's my own business, but I'm doing very well, thank you! Anyway, I digress.]

Not two minutes later, Bob, the Enzyte guy, appeared in an ad on the tube! Remember Bob? If not, see "The Two Bobs: Enzyte vs. Viagra". It seemed to me that Cialis was running ads in competition with Enzyte (perhaps vice versa -- like Wendy's building franchises across the street from McDonald's to piggyback on their market research).

So, Lilly has not "immediately" implemented its promised DTC changes. Why not? I haven't seen any Viagra ads on TV lately. It seems that Pfizer was able to cut those back rather immediately (that's a story for a future post). Why can't Lilly do the same? At least they could have said to ESPN to run the ads only after 10 PM. That wouldn't have broken a contract or cost them much, would it? Even so, they could have done it.

[The problem may be that not many parents are home to monitor what their kids are seeing on TV. What's the likelihood of a kooky parent like me -- a parent that cares -- being there with his son in the afternoon? Marketers might gamble that an after-school ED ad would escape notice and they would likely win the bet.

I am thinking of calling Lilly to complain. If you want to complain as well, try these people: Edward Sagebiel, +1-317-433-9899, or Phil Belt, 317-276-2506, both of Eli Lilly and Company. I don't know who they are, but they were listed in mouse-size print at the bottom of Lilly's press release. While you are at it, you might call Enzyte Customer Care at 1-866-834-1715 and complain to them as well. Good luck with that!]

Hey, Lilly said what it plans to do and it is doing it. I guess we are not yet in the "full compliance" mode; after all, there are still 30 days or so left until Lilly has to comply with the letter of it own code, if not the spirit.

Pharma Industry's Relief Effort

The pro-active actions of several pharmaceutical companies to aid of the victims of Katrina must be applauded.

The Wall Street Journal reported today that several pharma companies "have found ways to deliver donations of crucial medicines and medical devices directly into the Katrina disaster zone," skirting the red tape that has hampered some other relief efforts (see "Drug Companies Handle Their Own Deliveries").

The industry also contributed "nearly $45 million in medicines, medical supplies and cash have been committed to relief efforts and the amount continues to increase by the hour. The total does not include the contributions of PhRMA member company employees and the many companies committed to matching the pledges of their workers," according to a PhRMA press release (see "America'’s Pharmaceutical Companies Continue Relief Efforts; Nearly $45 Million in Medicines, Cash Donated So Far").

But the most impressive actions involved companies that mobilized their own resources to get supplies quickly to victims. Lilly, for example, got theirr incidence-response team to ship supplies using the corporate jet. Abbott delivered a truckload of supplies: "Within 24 hours, the company had loaded Similac infant formula, Pedialyte rehydration solution, Ensure nutritional drink, and diagnostic devices bound for other locations onto trailer trucks usually used as product showrooms."

I am not usually in favor of free enterprise taking on roles that should be the responsibility of government, but in this case -- where our government has proven to be inept and worse -- I am happy to see pharmaceutical companies and their employees step up to the plate.

Online Marketing Ethics, Part 1

New guidelines limiting DTC on TV may mean that pharmaceutical marketers are likely to invest more effort reaching consumers via the Internet and other interactive media (see, for example, "Pharma eMarketing at Tipping Point?").

As more money flows into DTC on the Internet, some ad agencies -- especially those who previously specialized in TV ads -- may pressure their pharma clients to "push the envelope" and engage in unethical online marketing practices. These "old dogs" need to learn new tricks (see "DTC in 2005: Old Dogs, New Tricks?"), but they also need to understand the unique ethical issues associated with online health information.

Sure, the old dogs may claim to know what's ethical, but will they deliver?

One of the most important online ethical issues concerns the clear demarcation between editorial content and promotional content. It is legally permissible to disguise promotional content by making it look like just another editorial piece or by not labeling it as an advertisement. But is it ethical?

For example, according to the CAN-SPAM law, which is a federal law attempting to limit spam e-mail, and FTC regulations, an e-mail newsletter sent to opt-in subscribers of a disease information web site owned and run by a pharma company can legally contain a product ad without labeling it an "advertisement." There are some hoops to go through to avoid breaking the law, which I won't elaborate here, but it's possible.

However, is it ethical?

No, according to the eHealth Code of Ethics developed in 2000 by the Internet Healthcare Coalition (IHHC). The IHHC, which I co-founded in 1997, is now disbanded, but the Code lives on and has been translated into at least 6 languages, including English.

According to the eHealth Code of Ethics:

"People who seek health information on the Internet need to know that products or services are described truthfully and that information they receive is not presented in a misleading way. Sites should be forthright

• in all content used to promote the sale of health products or services
• in any claims about the efficacy, performance, or benefits of products or services

"They should clearly distinguish content intended to promote or sell a product, service, or organization from educational or scientific content."

The standard practice is to label promotional content as an "Advertisement."

Ethics should not be regulated. The eHealth Code of Ethics was developed to help online marketers voluntarily "clean up Dodge" before the sheriffs (i.e., FDA, FTC, etc.) arrived and did it for them.

The FDA has cited a few errant online marketing practices of the drug and device industries, but it does not have the resources to monitor the vastness of the Internet. Nor does it intend to treat the Internet in any special way.

However, the Internet is different than TV. With TV you usually know what's an ad and what's not. The Internet is not linear like TV and it is more difficult to distinguish an ad from editorial content unless it is labeled.

There are some advertising practices being used on TV that attempt to disguise ads, such as product placements inside sitcoms or movies. I think these practices are unethical for the same reason that disgusing promotional content on the Internet is unethical. Obviously, however, the ad people do not have any qualms about it. These may be the same people developing prescription drug ads on the Internet in the future! Will they will develop new tricks and push the envelope on the Internet as effectively as they have on TV?