Cliff Mintz in BioJobBlog (July 12) says pharma has discovered You Tube in a big way. He says many drug companies are using it to post ads, educational videos and creating contests for consumers to create videos on what it is like to have certain diseases. He singles out J&J saying “these pharma assaults on YouTube pale in comparison to the launch of Jonson & Johnson’s health channel on YouTube.” He says social media is the “next best thing since DTC advertising.” His concern is that this is unregulated, and like the rest of the Internet, needs clarification from the FDA on what is permissible. I doubt conservative big pharma is going to post anything that is not fully vetted by their regulatory and legal group, so Mr. Mintz should not expect unapproved YouTube drug claims coming from pharma.

The Wall Street Journal Health Blog of 7/22 from Sarah Rubenstein also deals with social media use. This blog, however, is concerned with doctors using social media like YouTube to push their services. Doctors are apparently offering discounts for consumers to give online testimonials. Now, here is where I get concerned about unregulated claims. Many of the social media is used for cosmetic procedures and there are many less than qualified physicians dabbling in cosmetic surgeries.

Before anyone gets too excited about Internet social media, HeathCare Vox reports that most drug discussions happen peer to peer directly rather than online. Fard Johnmar writes on July 18 that less than 10% of social drug discussion happens online while 74% occurs offline. His conclusion is that while the Internet is important, marketers must remember most social interaction happens other ways.

In his July 24 Pharma Marketing Blog, John Mack noted that Lyrica, the Pfizer drug for fibromyalgia, had recently modified its DTC ads. Pfizer had run a controversial ad showing what looked like a battered woman to demonstrate how a patient feels when they have painful fibromyalgia. Mack had commented in prior blogs that he did not like the portrayal of woman as battered. He said it showed DTC entering a new low in how far it would go to sell product. The new Lyrica ad is much more upbeat and John Mack wonders if he may have been responsible for the ad change. I doubt Pfizer would have changed its ad for any other reason than this one tested better. Mack may be correct that disturbing images may turn off potential users and therefore, the happy couple ad now used is more appealing.

Mr. Mack also had an interesting blog wondering about how long a DTC ad can say “new” in advertising. His blog of July 17 questions whether a product that agrees to a 6 month moratorium for new products can still use the word new in its DTC advertising. DDMAC says new is usually only used for 6 months from the start of marketing, which would be to doctors first. Mack bring ups an interesting point. Once the 6 months marketing is done and DTC starts, does that now preclude use of the term new in DTC? My take is that it is not that important whether new is used in the ads. We (I worked on it at launch) did not advertise Lipitor for 2 years after launch and the use of new was not considered important in our success. I think the term new has more meaning in consumer products ads than in drug ads.

In Joe Mantone’s Wall Street Journal 7/23 blog, he writes about a column by fellow columnist Dr. Benjamin Brewer. This column points out that consumers are increasingly skipping medical care to save money. While this column appears to be only based on anecdotal evidence, it seems reasonable to conclude that consumers may be saving money by putting off medical tests and self-medicating versus visiting a doctor. Dr. Brewer’s concern is that he thinks waiting to see a doctor leads to potentially higher risks and costs later. This leads to a thought that in bad economic times public health campaigns may be needed even more to motivate consumers not to put off health checks.

The Wall Street Journal’s Alicia Mundy (July 17) discussed in her blog how drug lobbyists are dealing with the fallout of the Dingell/Stupak hearings. She reports that two lawyers from PhRMA visited Congressional staffers to discuss industry steps to regulate DTC. Dingell told the WSJ, “I’m pleased that PhRMA is reviewing its DTC guidelines and has met with the committee to discuss the concerns we outlined.” Dingell also said that if PhRMA is going to be serious about resolving concerns, then they would not hold additional hearings. Dingell did also play the heavy saying that they expect results, and if that does not happen in a timely manner, “the committee will be forced to consider whether a public airing would be a more productive way to proceed.” I doubt much will happen until we see the results of the 2008 elections. I am sure there will be more aggressive attempts to add a moratorium and pre-clearance if we have a firmer majority of Democrats in Congress and an Obama victory. PhRMA clearly wants to keep inflammatory issues off the radar screen in a more hostile legislative environment.

The Prescription Access Litigation (PAL) blog of July 25 raised alarm bells about how consumer prescription data is being mined. Their concern is that patient prescription records are being sold by drug chains for data mining purposes. PAL says data mining is wrong and leads to nefarious use of patient data. One of the issues they say is that insurance companies use your prescription data to deny coverage. PAL wants to see more privacy regulation and is part of litigation to support states’ efforts to curb data mining. The drug companies would argue that data mining offers consumers relevant information and is kept private.

Mike Huckman of CNBC blogged on 7/24 that the economy may be having a negative effect on erectile dysfunction drugs. Since these drugs are “pricey and may not be covered by insurance,” Huckman says there is some sales evidence that ED drug sales are declining. Huckman’s blog brings up an interesting implication for DTC. Consumers are really more in charge of their economic outlays for prescriptions, not just for ED but for any drugs with a high price tag and high co-pays. Any branded drug maker needs to recognize that they must prove value to consumers compared to cheaper brands and much cheaper generics. The slow economy only heightens this trend to consumer power.

One of the common concerns of DTC marketers is the constant need to justify DTC spending to their management. After more than a decade of use, DTC is still apparently not seen as something that has become routine spending. I call DTC a bubble expenditure because some senior manager at big pharma is always considering cutting it out.

There are several reasons for DTC to be in this precarious state each budget season. First, Mr. CEO is always worried that DTC angers legislators, physicians, consumer advocates, insurance companies and managed care. In fact DTC may only be popular with advertising agencies and the media companies’ sales departments. CEO’s wonder if it is worth the hassle. Will DTC cause a tipping point in legislation, they ask.

Second, since detail forces are now being cut, internal sales management is going to be aggressive in insisting DTC be ROI justified. Budget cutting is increasing and DTC is a nice pot of dollars to grab.

Third, DTC ROI’s are good, but not great. DTC generally does not create blockbusters. DTC returns are usually acceptable, about 2 to 1, but that means an average budget of about $50 million gets you $100 million in sales. That is only 10% of a blockbuster sales level.

I am afraid that every year DTC marketers will face the threat of being considered obsolete. The fact is, however, that almost all major brands have continued their DTC and cuts have been modest. That being said, DTC managers do not usually need to take out a 30 year mortgage. It is unlikely there will be too many DTC managers working for the same company for a career. The good news is that when one company cuts, others start using DTC. I have seen no evidence that DTC is undergoing a major reassessment industry wide. Individual companies may decide to lower their DTC investment, but most will accept the nice 2 to 1 returns.

I suspect that DTC managers feel like fishes out of water explaining DTC to their management. Clearly the typical senior executive is not consumer or technology savvy. Their ears will perk up discussing an R&D project, but DTC discussion causes them to get that uncomfortable feeling. There is no easy fix for this since few CEO’s will have been raised in a consumer products environment. The best way to present DTC plans is to have clear, quantitative measurement criteria that management understands and buys into. It is also important to present DTC for what it is; the best use of incremental spending versus other promotional alternatives.

I am still very bullish on the future of DTC as a promotional tool and as a career. There will be ever increasing consumer co-pays for newer drugs. Therefore, drug companies are going to need to directly convince the end users that expensive new Brand X is worth more than cheaper old Brand Y. There will also be more lifestyle drugs that have no reimbursement, requiring innovative consumer marketing. American consumers are information junkies and that also bodes well for those companies that can reach them in terms that are consumer friendly. Will DTC always be on the bubble? Yes, that is likely as long as former R&D managers, lawyers and detail reps run drug companies.

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In a Wall Street Journal blog by Alicia Mundy (July 15), Billy Tauzin, head of PhRMA was quoted saying, “Our members were advertising life-saving medicines like it‘s Pepsi and that hurt us.” Tauzin was referring to all the flak from Congress recently leading to new promotional guidelines on gifts to physicians, as well as the 6 month voluntary DTC advertising moratorium on new products agreed to by several companies.

Tauzin wants to “stop the bleeding” in reputation of the industry. He wants drug companies to get ahead of the stories that are negative. Ok, good comments, Mr. Tauzin. The drug industry has a lousy reputation and it is not getting better as I reported a few weeks ago from a Harris Survey.

On the other hand, where has PhRMA been during all of this decline in reputation? I do not remember PhRMA being a leader to head off the trouble. I realize they just reflect the will of their members but their DTC code was introduced about 10 years after it was needed. I do not remember any push to lower prices until a few years ago when the PPA with Montel Williams became active. Tauzin may be different from past PhRMA leaders in his desire to change drug company behavior to be more public-centric. I certainly hope so. The reality is all of the issues creating negative feelings have been around for a decade and drug companies were aware of their declining image.

The industry will not stop the image bleeding unless the following occurs.

First, anyone who is among the low income uninsured or underinsured needs to have drug prices that are affordable through price support or free drug programs. I know PPA is supposed to provide that help. The true measure of its success is the proportion enrolled being high enough to change the perception. I think the current numbers are low in proportion and the publicity on that program needs to be greatly increased. Saying it exists and making it work are two different things. Congress will only back off price criticisms if they no longer hear their constituents complain.

Second, safety issues must be dealt with quickly and pass the smell test. Drug companies with safety issues must bite the profit bullet sooner if they are to build credibility with the public. Denial and legalistic defenses may delay product withdrawal and liability payouts, but that delay comes at a price of image. PhRMA must act to ensure all risks are clear in any advertising, and that means readable patient friendly brief summaries should be part of any code.

Third, drug CEO’s need to get more involved in ensuring their organizations are more consumer-centric. I have said this many times, but drug companies are still largely detail sales, clinical research, regulatory and legal organizations. Neither their senior management teams nor their boards are usually consumer-centric in background and action. Are there any senior managers reporting directly to the CEO who represent consumers? Please let me know if they exist.

Fourth, drug companies must succeed in developing the breakthrough drugs. I know they are trying and expending a lot of money in the effort. Until we see significant breakthroughs, however, it is unlikely more me-toos will convince the public and Congress that drug companies deserve a break in criticism. When the DTC is on cancer cures, no one will criticize drug companies for the creative style of their ads.

So, Mr. Tauzin, keep pushing the drug CEO’s to stay ahead of the issues. Unfortunately, given the bad public reputation, Congressional outrage, low stock prices, and escalating layoffs, they have a long way to go.

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In PhRMA Guiding Principle 13, it says “DTC television and print should be targeted to avoid audiences that are not age appropriate for the messages involved.” Sounds clear, but is it really? Erectile dysfunction (ED) drugs are being criticized for advertising on daytime sports. In fact, the president elect of the American Medical Association testified at the recent Stupak-Dingell hearings how embarrassed she was that young children were seeing these ads.

Is targeting older men during the day against this principle of appropriate age targeting? I saw a Cialis ad early morning during a major golf tournament. It is entirely possible many young children were watching with dad/mom or happened to be in the room when the ad aired. On the other hand the ad aired targeting older men, the television golf target audience. I do not see how you can criticize the drug companies for airing ads when their target audience is watching. Many feminine hygiene products air during daytime soaps. They are full of potentially embarrassing statements.

I admit explaining a 4 hour erection to a child is probably difficult. Then again, so are a lot of things they get exposed to during daytime television. There is plenty of violence and sex shown on many daytime shows. I know parents would prefer not to have any embarrassing programming or commercials air when children could be watching. That is not going to happen in today’s 500 channel world.

Drug companies, I agree, should not target erectile dysfunction ads on shows with very broad age targets. Golf, however, is not one of them. Most sports shows target older men, but are also watched by some kids. That, I admit poses a dilemma whether to run ED ads. My view is it is never going to be easy to avoid kids seeing these ads. Drug companies do not want to waste ad impressions on teens or pre-teens. It is really up to parents to turn down the sound if they see an ad appear. After all the 4 hour erection warning comes late in the ad, with plenty of time to put the mute on. Sorry mom and dad, but keeping the kids ears ED ad free may take more work these days.

I would not think Congress needs to be in the media planning business, nor should the AMA. The media outlets can always refuse to air an ad they think will offend their audience. So far it seems, they think golf is fair game for ED ads. Given the more worrisome violent content of video games, rap music and Internet sites, parents have more serious issues to worry about than explaining erections.
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In the category of whopping misinterpretation of the facts, a Dr. Mayer from Albany Medical College in New York writes in the Times Union web page on 6/24 , “There are fewer pharmaceutical detailers because the drug companies are shifting their advertising emphasis into the direct-to-the consumer ads.” His blog was on the need for regulating detail reps, but that is an aside. In fact, detail reps are being cut because they were no longer profitable. Too many reps were detailing the same products with little news to offer. The cutting of reps would have happened with or without the option of DTC.

As a follow up to the June hearings of Mr. Stupak and Mr. Dingell, the AMA web editorial concluded (June 9) that “DTC drug ads are a big business. Given its pervasiveness and questions about its impact, the industry is one that warrants more scrutiny and better regulation.” What does AMA want? They want a moratorium on new drug DTC ads with the length determined by FDA. They also want FDA pre-approval of DTC. Most drug companies will agree to a voluntary moratorium of 6-12 months, as some already have, but will not agree to pre-approval of the DTC ads. Pre-submission is acceptable but pre-approval is not.

Pharmaceutical Executive’s George Koroneos commented on 6/18 that the recent actions of drug companies on the 6 month moratorium “might not be enough to satisfy legislators looking for major pharma advertising reform.” I am sure he is correct in that assumption. No doubt the anticipated strengthened Democratic majority will keep the pressure on for more restrictions. Clearly Stupak and Dingell are not satisfied with the 6 month number.

The Wall Street Journal’s Jacob Goldstein commented (6/17) on several pharma companies’ 6 month agreed on moratorium. “The customary 6 month wait isn’t exactly an act of charity or contrition. Drugmakers generally want to send in their reps to tell doctors about new medicines before DTC ads drive waves of patients into their offices… ”

Scanning even the most obscure locations, I found a blog in the Duluth Daily Telegram web site (June 28) from Mike Savage. Humorist Savage says, “I’ve been wondering, would our next President be willing to make drug ads illegal..please?” He goes on to say that “Big Pharma won’t allow even Barack Obama to pull that off…” As a writer, Mr. Savage should be familiar with the first amendment and that even Barack Obama would have to allow commercial speech. He may get further regulation that makes it harder to execute television ads, but making them illegal, I think not.

In the category of the most blatantly obvious anti-industry title, the web site called Stop Drug Ads said on June 20 that “each year drug executives spend $4 billion on prescription drug ads… the ads are not educational and do not promote public health. They can be extremely dangerous, as the Vioxx tragedy shows.” Their purpose is to get support for legislation to ban all drug ads or if it is unconstitutional to do that, then they want more warnings, no tax deduction for marketing expenses and a 3% windfall profits tax. Who is on the board of this organization? Ralph Nader and many well known educators and public advocates are part of it. Ralph told me a few years ago that he knows it is likely unconstitutional to ban drug ads.

The Society for Women’s Health Research (June 17) had an interesting request of FDA. They want FDA to “require data collection on how DTC advertising affects women and men differently.” They feel gender differences are reported in drug approval, so why not understand gender differences in DTC ads?

In the anecdotal evidence is better than real facts department, The People’s Pharmacy blog of June 15 said “Most people tell us they hate TV drug ads.” They go on to say “Many ask us why the FDA permits such ads…” Oh really? None of the credible surveys on DTC suggest most people hate DTC ads. They may find them annoying at times, not suitable for their children, or hard to follow during the side effects section. But hate them? No, that is not what most people say.

In the debate over why drug companies do not use as much web media as other industries, John Mack of the Pharma Marketing Blog weighs in on June 30 . John believes “pharmaceutical marketers have a mass market mentality and do not view the Internet as a mass market medium.” I like John’s blogs because he actually does some data analysis that supports his views. He says non-pharma spends 7.3% of their budget on the Internet compared to 3.1% for pharma. This debate about why has been going on for years now. I think it is largely because the general Rx drug 50+ target audience is reachable on mass media compared to other products geared for under 35 age groups. I do not think pharma marketers dislike Internet per se or are lazy in considering it. It is up to Internet media to convince them they would get a better return spending more. One should not b lame the customer for not being faster adopters. I think if it does make sense, and I agree it does, then pharma marketers will use it more in the future. Of course legal and regulatory concerns also inhibit its use.

Genetic testing may be the next large category for DTC advertising. California and New York regulators are making it difficult for companies that do this testing by adding onerous and costly restrictions. Rick Weiss, writing on alternet.org June 26 says the “moves by California and New York are the clearest evidence yet that a federal leadership gap now threatens to undermine the pending benefits of the genomics revolution.” Weiss is correct that a myriad of differing state regulations make it impossible for these new tests to be made available to the public in a cost effective way. While states have the right to protect consumers from faulty or ineffective tests, it is hard to imagine they have the expertise to do this well. There must be a uniform national set of rules for approving and regulating home genomics testing.