I applaud Sanofi-Aventis for trying to break through the recent trend of safe, formulaic DTC ads. Ambien marketers must have seen something in the Rozerem spots they found intriguing and appealing. A mysterious rooster is a nice future icon for extended use across all media. It is also fairly easy to interpret once you realize it is for Ambien. It takes a little less psychology training to understand than did Lincoln and the beaver. The use of unbranded spots also saves Ambien media money versus standard branded ads. If they can get website visits for less per visit than using a branded 30 or 60 second spot, so much the better.

The use of the darkly comedic rooster may arouse the wrath of Congressional watchers who recoil from uses of non-serious spokespeople or in this case spokesfoul. One must admit the mischievous rooster does not have the scientific credentials of the usual DTC on-camera doctor. So, expect the usual criticisms about making drug products less serious. Remember this is the drug that supposedly caused Congressman Kennedy to crash his car into a Capitol wall at 3 in the morning.

I assume Ambien marketers debated the fallout potential from using the rooster and decided it was worth the risk. The rooster will not likely have to appear to testify in front of Dingell and Stupak although he might make more sense than many Congressmen.  Will the rooster do more for Ambien sales than the beaver did for Rozerem? That is the question. I am sure all the ad critics will be watching to congratulate or vilify Ambien marketers depending on which way the pill sales go.

I am fine with the new campaign. It is cute, buzz worthy, and expandable. I would not use such an approach for a cancer drug, but for a well-accepted sleep aid I have no problem. 

A new study by DDMAC is going to delve into whether television ads have distracting positive visuals which limit consumer risk information comprehension. DDMAC has always made judgments subjectively when pre-reviewing submitted ads on these distractions. They never liked commercials that had too many moving parts while side effects and risks were discussed.

This is the first time that DDMAC will try to get some definitive consumer data on whether positive visuals really do distract from consumer comprehension and retention of risks. They will test mock ads next year and get some data. This will be used for determining whether new guidance is needed on visuals and supers.

I support the study because DDMAC has assumed that the pretty background visuals that have too many scenes are distracting. I remember the original Lipitor ads were rejected because our background visuals showed a car moving too fast as risks were read. DDMAC made us slow down the motion of the car. None of us agreed with their subjective assessment but once the reviewers decided, there was no way to refute their views. Their subjective view trumped our subjective view. So anything that is based on quantitative data is worthwhile.

There have been studies on risk comprehension by drug companies. AstraZeneca did some excellent work on the number of risks consumers can process and found less is more. This DDMAC study will be done in 2009 sometime. I assume any new guidance on risk presentation on television will not be out, if at all, before 2010. Better late than never I guess, as DDMAC has waited 12 years after they allowed branded ads to finally do this study. I think the lack of research by DDMAC is a problem. They need to have the staff and budgets to test a number of creative factors in ads. It is a sad state of affairs that it takes so long to replace subjectivity with some actual consumer data. If you want to provide DDMAC comments on this study it is docket number 2007N-0321.

So I look forward to this data and future studies. I hope DDMAC can accelerate their future market research because consumers deserve clear information on all elements of DTC ads. I know DDMAC personnel are doing their best with current resources, but resources are the problem. Instead of political bluster from Stupak and Dingell, give DDMAC what they really need to oversee DTC advertising.

John Mack in his Pharma Marketing Blog of 8/14 wrote an interesting piece called Rethinking the Value of DTC Advertising . Mack says that the numbers of patients who visit and ask doctors about advertised drugs is very low. Therefore, he wonders how the expenditures can pay back on this low a number of patient Rx starts from DTC. He believes the payback comes from increased compliance as current users are reminded to stay on a drug. Mack is partly correct. DTC ROI comes from a combination of both new starts and compliance reminders. The average ROI is 2 to 1 and that does not require a large number of new patient starts. Mack sites a 6% rate of patient visits scheduled because of DTC. It only takes about a third of those to get a branded drug to payback. The compliance portion is probably the minority of the benefit.

In Jim Edwards’ Brandweek blog of 7/29, his post is called Drug Marketing Poised For Historic Decline . Edwards’ pessimistic call is based on decreased drug pipelines and a more conservative FDA slowing the approval of new drugs. He thinks television will be the medium most hurt. Edwards looks for declines through 2011. Spending was down in 1Q 2008 by about 3%, so Edwards is likely right about 2008 being a down year. Drug companies are looking to cut expenses through headcount reductions and spending cuts. I doubt we will see dramatic declines in DTC spending, but 5-8% for 2008 and annually through 2011 is not out of the question. I do not see this change in attitude about the effectiveness of DTC, but merely a reaction to profit needs short term.

Edwards also wrote a piece for Adweek on 8/15 , citing a decline in creative effectiveness of recent DTC ads. His source is a Nielsen IAG study showing DTC ads are less memorable this year. The cause is cited as some of the most memorable ads in 2007 were pulled because of publicity or sales issues. Pfizer pulled the Jarvik ads, Rozarem’s Lincoln spending was cut way back because of slower sales, Vytorin’s food and people ads were pulled because of clinical study issues. Fariba Zamaniyan of Nieslen IAG said increased attention of the FDA could cause more conservative creative approaches. The standard vignette approach of older people could be less memorable.

Niko Karvounis blogged a critical column on AlterNet.org on 8/11 called How Big Pharma is Fooling You With Junk Science . The 3 page blog criticizes drug companies for using misleading spin over science in marketing their drugs. His point is that drug companies will spin results to convince consumers and doctors that drugs are more effective than they really are. Karvounis does not comment on the fact that the FDA reviews all ad claims and detail pieces, and they must contain only label claims. Of course drug companies try to position all ad claims with a positive spin, but it still must be accurate.

In Multinational Monitor’s July/Aug issue , Melody Petersen, author of Our Daily Meds is interviewed. The book is highly critical of drug company marketing. Ms. Petersen says “drug companies have learned to use science as a marketing tool.” She cites DTC as trading in “fear about a disease.” She says drug ads sell “youth and happiness and friends and beauty and sex.” This book is similar to many recent books hammering industry marketing. It is different in that it focuses on marketing practices. Ms. Petersen talks like the industry can say anything it wants. The FDA does ensure fair balance in ads despite Ms. Petersen’s assertions. She is right – there are abuses, but vastly overstates them.

In the anti-drug industry state of Vermont , Representative Harry Chen writes a blog in the Rutland Herald on 7/24 about undue influence of drug companies. Chen is also a physician and feels doctors take too much cash and merchandise from drug companies. He also is critical of their learning about drugs mostly from drug reps. Chen gets his drug information from an unbiased source, The University of Vermont, funded by the state. He cites Vermont as being a leader in regulating drug company marketing. Chen’s column is instructive in that a new Congress could adopt many of its techniques to clamp down on drug company marketing.

A blog in the Fay Observer on 8/17 was critical of DTC ads on the Olympics. David Work, ex-director of the North Carolina Board of Pharmacy, says he saw many DTC ads. He is concerned that we monitor athletes for drug use, but then advertise drugs on the coverage. He says promotion of drugs during the Olympics is irresponsible. I can understand his concerns if the ads were for performance enhancing substances, but they were for sleep aids. I think he is stretching the issue that somehow advertising prescription sleep aid drugs will send the wrong signal to impressionable young viewers about drug use.

Ok, I do not have all anti-drug news. The Times, London Times that is, had a blog on 8/18 by Stephen Pollard called Drug Companies are a Boon, Not Our Enemies . Pollard runs a think-tank in Brussels and proudly admits to getting funding from big pharma companies. He chides governments for criticizing drug companies for making excessive profits. He smartly points out that government controlled science does not usually produce new drugs. “In all of the Soviet Union’s existence… not one discovery was made that scientists in the free world considered using.” Pollard cites the high costs of R&D and risks as a reason not to decry profits. It is good to see The Times give the pro-drug industry argument some space.

The idea of countering drug company marketing with government funded detailers is growing. Time Magazine did an online story August 12 on a South Carolina program to provide alternative drug information to physicians. The purpose is to offer a non-commercial rebuttal to drug detailers and DTC ads which promote branded drugs. Time says the doctor gets most of their information from “the chipper, gift laden pharmaceutical sales people.”  

Time says that there is no data yet on the effectiveness of the South Carolina program. The program uses pharmacy reps from the South Carolina College of Pharmacy. It is funded by the state’s Medicaid program and clearly is designed to reduce prescribing of branded drugs. The Time story cites Pennsylvania as having a successful program, using the example of state Nexium costs being reduced by $572,000. That sounds like fairly modest savings for such a widely used drug.

I have no problem with counter detailing. It fits the free market solution, which is that more information is better than less. Let the doctor decide who provides the most credible evidence of a drug’s value. Clearly the state sponsored programs have a goal to reduce costs and although they say they want to provide unbiased studies to doctors, I doubt that will be the case. More likely they will find studies that show the branded drugs have marginal value.

Counter detail programs are likely to be small scale and unlikely to have the muscle to counter the mass of drug company sales forces. This may change if the federal government steps in to make counter detailing a major effort. They may also decide it is more cost effective to do counter DTC efforts. That would be quite interesting to see mass DTC extolling the virtues of non-branded drug treatments. Imagine a few billion spent on that! I can even see Congress forcing the drug companies to fund it somehow.

Physicians deserve to get all the information about a drug’s effectiveness and safety. If these programs help them make a better decision, that is great. It will motivate drug companies to provide more compelling reasons for branded drug use and may lead to less me-too thinking. That is good long term for all of us. Congress should focus on these information-based approaches to reducing cost, not through limitations on speech.

Jim Edwards, who used to blog about advertising at Brandweek, is back writing his own blog. His July 29^th blog was titled “DTC Pharma Marketing’s Glory Days Are Behind Us.” His rationale is that the lack of new drugs is the chief cause. He cites flat spending recently after significant increases a year ago as the evidence.

I would agree DTC spending, like all big pharma spending, is under pressure. Detail forces have been cut, manufacturing centers have been consolidated and headquarters staffs are being reduced to protect profits. DTC is certainly not immune from cuts.

To say the days of big spending are over is a premature conclusion. The number of brands spending more than $50 million on DTC is actually up versus last year. Most new brands are using it still. Mr. Edwards said television will be the chief casualty of the cuts, with other media keeping their budgets. He says “the days when primetime was filled with drug ads is going to fade from memory.” Of course if massive cuts are going to be made in future DTC budgets, television will be the biggest loser since that is where 60% is being spent.

Pundits have been confidently predicting the end of mass media DTC for years. They will be right one day as on demand viewing takes over. To date, there is no evidence of a major shift. DTC spending may be down 3-5% this year. That reflects current economic conditions and I do not consider that conclusive or that the glory days are over. If we see consistent 10% declines over several years, then we can say there is a permanent decline.

DTC mass media will be used as long as it is legal and it delivers a good ROI. The online, point of care and direct media will grow nicely as brands strive to target their spending and get stronger ROI. The issue with spending 100% on targeted media is finding ways to get the same scale as mass media.  

The glory days may be waning, but there will be plenty of years left in sub-glory mode. We will see if Jim is right as the actual numbers come in for 2008. My bet is on a modest decline, not an end to DTC as we know it.

“DTC mass media will still be used.”

The Wall Street Journal reported on 7/30 that there is growing sentiment in Congress to drastically reform the FDA so it has fewer ties with the industries it regulates. There are many in Congress who feel the FDA has done a poor job protecting the public and is too close to the drug and food industry. 

John Dingell is quoted as saying, “There’s a total inability of the FDA to carry out its mission.” The WSJ story by Alicia Mundy says “leading Democrats would like to see less Madison Avenue-style television commercials for prescription drugs.” It is not only leading Democrats unhappy with FDA. Senator Grassley, a Republican, has been leading the charge saying the FDA is too cozy with companies they regulate. Of course DTC is only causing a small part of the anger in Congress towards the FDA. Congress is concerned with food supply safety, drug recalls, FDA ability and willingness to impose penalties, and speed of response to crises, among many others.

Alicia Mundy says, “2009 may bring the most significant overhaul at the FDA in a generation.” Should DTC advertisers and all those whose livelihoods depend on the existence of mass DTC advertising be worried? My view is a modified yes. No one is talking seriously about banning DTC ads. The key issues are over a longer moratorium on new products and FDA pre-approval of ads. The advertising industry is opposed to both, fearing a slippery slope of added regulation leading to perhaps a full ban.

Many leading drug makers have already endorsed a 6 month moratorium, and the issue is the additional 18-30 months wanted by many in Congress. Most television ads are pre-reviewed by DDMAC on a voluntary basis, so making it mandatory is not as drastic a practical change as it seems. I do think a Democratic administration and Congress will press the industry for more than 6 months and probably get an additional time commitment to hold off ads for new products. The industry has to appear willing to negotiate because I doubt Congress will accept the 6 month number. My guess is that 12 months will be the negotiated time frame.

A more legislatively empowered and staffed FDA can make it harder to do DTC as we know it, even without changing the moratorium time frame or requiring pre-approval. They can just find more things that they say are violative and reject more ads. How can they do this? They can cite distracting visuals when risk is discussed or cite claims that are not fairly balanced. I never thought DDMAC was easy to get claims through when I worked with them in the 1990s. So a new tougher policy may add significant delays and uncertainty to fielding television ads.

Of course a tougher FDA may not make all DTC marketers upset. Those marketers and suppliers in the Internet area and point of care environments may benefit from more restrictions on broadcast ads. Also, print ads may become easier to execute than television if more risk explanation is required. I am highly confident the FDA is not going to return to pre-1997 days and legislate television out. It just may be harder to do 30 and 60 second ads.

Individual drug companies should act carefully when constructing their broadcast ads. Any ad that sounds like a shampoo commercial is likely to get Congressional attention. I would keep my ads sober, informative and shy away from comedy, celebrities and cutting edge creative techniques. That may make the agency’s creative job “less fun,” but industry image is critical over the next year. I also expect the new FDA to do more studies on what consumers perceive ads to say versus what they actually say. Some ads may comply with the approved labeling, but consumer interpretation may extend those claims into an unapproved area. Although more Congressional action on drug regulation has been threatened for years, I sense 2009 may be the year something really happens.