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Trade magazines can be found in every industry and some actually can be a source of great information for marketers. DTC Perspective is not one of those magazines. While thumbing through the latest issue they featured a report on awards, that they sponsor, and everyone seemed to win either gold, silver or bronze awards. This is called good public relations to ensure that DTC marketers sign up for future seminars held by DTC Perspectives.
Let's look at DTC Company of the year..Sepracor for their Lunesta campaign. According to website hits (see below) Lunesta is far behind market leader Ambien and only slightly above the disastrous Rozarem. Correct me if I am wrong but the whole purpose of a DTC campaign is to gain market share? The Silver winner was Botox Cosmetics..I am not even going to go into why they should not be considered for DTC awards.
Ambien CR is
leaving Lunesta in the dust in website hits and
Rozarem doesn't
even register !
For
sales over $5 billion the award went to GSK for their
work on Boniva, Levitra and Avodart. This to me makes
some sense. The spots for Boniva with Sally Fields
are great and communicate the unique point of
difference (once a month vs every week). However
Levitra's campaign, with the causes of ED, may have
hit a niche in the market but have failed to move the
market share needle. The Bronze award went to Amgen a
real DTC powerhouse and that alone should tell you
just how bad these award choices were.
These awards mean nothing but they do make
marketers feel good about themselves. They can go
back to their managers and say "look, we won" and pat
themselves on the back with the false sense that they
actually did something that added value to their
brands. However management is now starting to dive
deeper and deeper into the marketing dollars spent on
DTC. Want $40 million for a new campaign? Tell me
what it's going to do for share and how we are going
to measure it? Of course there are a number of savvy
marketers who can manipulate data to show that what
they spent actually drove share.
It's a shame that some marketers actually believe
this hype and self promotion. This author was part of
the DTC team of they year a while back for Cialis and
I can tell you that the award and $1.50 might get me
a New York subway token.
There is a lot that is wrong with DTC today and
pharma companies are not willing to fix it. Less than
1% of media, for example, is allocated to the
Internet at a time when premiere marketers like
P&G are allocating more dollars to the Web and
moving away from TV. When I receive an issue of DTC
Perspective I think next time it will just go into
the round file where it belongs with all the other
promotional materials. DTC marketers need to stop
looking for awards and start looking at the sales
numbers and patients response to ads before they pat
themselves on the back for a job well
done.
Since the NY Times does a great job of kicking big pharma around I thought that I would share with you some of my experiences during my five years at Eli Lilly at Indianapolis. I was primarily in the eMarketing area and worked on several brands including Prozac, Sarafem & Cialis. I learned a lot during my five years and although I am not an ideologist I would have left Lilly sooner if I thought there was any truth to claims that Lilly pushed "off-label promotion of ANY product.
While employed at Lilly we were required to take quarterly compliance training. During this class we were given instruction by our legal, medical and regulatory people on what we could do and, more importantly, could not do. Each employee, including Directors, then had to take a test to ensure that they understood the course materials. In addition there was a book of ethics that Lilly maintained called the Lilly Red Book. Again we were required to read this book and take a test to ensure that we understood the materials.
When preparing marketing materials we were required to go through a MLR review (medical, legal and regulatory). I can tell you first hand that this team tended to be very conservative in both DTC and DTP materials. If it didn't say it on the label then we didn't say it to physicians or consumers, end of discussion. I can't tell you how many times we argued with the MLR team but their word was final as they were the ones who had to sign off on all materials. As a marketer I often shared with them insights that we had learned during consumer or physician research so they had a better understanding of why we were proposing certain tactics. This led to a better session and after working with my MLR team I gained their trust but they continued to scrutinize every marketing message.
During my time with Lilly one thing always seemed to guide me. The Director of Marketing Services told us in a group meeting once that we should do everything just as if a patient, or consumer, were sitting right by our side. Lilly's slogan is "answers that matter" and in everything I observed and did we always tried to provide patients with the answers to questions on our products. In the rare occasion when a brand team received a letter from the FDA the MLR team would immediately go into action to amend or suspend the materials in question. Management told us, in so many words, that a letter from the FDA was unacceptable and that "it won't happen again". (translation if it does there is going to be hell to pay)
I was proud to be a Lilly marketer and I am still very proud to list Lilly on my resume. A company is only as good as the people it hires and retains. Yes, there might have been some mistakes made by some people in the past but for the most part they were shown the exit. Because of my time at Lilly I am a better marketer and while there I was able to convince some senior people that the Internet was a great channel for communicating with our audience and that the Web was about users, not about pushing information to visitors.
I read the NY Times everyday and for the most part I consider it a good newspaper. They have had some major blunders of their own in recent time but I won't hold that against them. I am extremely disappointed at the recent set of articles that ran in the Times on Zyprexa however. It was old information and the Times never seemed to question the motives of the lawyer who released the information. That's ashame because there are a hell of a lot of good people at Lilly who deserve better and who are trying to make a difference in patients lives..and that is what it is all about.
If you had a chance to read my BLOG last week then you are well aware of the NY Times articles targeting Lilly's marketing practice for off label use of Zyprexa. Forget that this was leaked by an attorney who is in litigation with Lilly and has a vested interest in releasing this information what really strikes me, once again, is the lack of research by the NY Times and the reporter who wrote the articles. Two medical journals have stated that off label use is common among practicing physicians.
According to an article in August of 2006, the Annals of Internal Medicine stated the following:
Off-label use is the common practice of prescribing a drug for an indication other than those approved by the FDA. The physician rationale for prescribing off-label is often based on the lack of FDA-approved effective treatments, reports of clinical effectiveness for the off-label use, or both. A recent study confirms that off-label prescribing continues in earnest, with 21% of drugs listed in a data set being prescribed for off-label uses, most with little scientific evidence of efficacy. Although the responsibility for seeking FDA approval for adding new uses to the product label resides solely with the manufacturer, companies are reluctant to invest the resources necessary to develop the evidence required for FDA review, particularly when the off-label uses are already profitable.
In addition another article in the Archives of Internal Medicine in May of this year found:
Off-label medication use is common in outpatient care, and most occurs without scientific support.
So what does this mean? It means that physicians are doing what they feel is in the best interests of their patients. They don't have a lot of confidence in the FDA or pharmaceutical representatives to give them the information they need to make decisions based upon what is best for patients. Pharma companies, for the most part, do not promote off label use of their products and anyone who engages in such behavior is subject to immediate termination. It also means that once again a reporter did not present a balanced news story that was researched in depth.
Next time I read a story like this I am going to check my drivers license to ensure that I was not born yesterday...
Astra Zenca's website on breast cancer (www.getbcfacts.com) is an example of just how good a website can educate and inform consumers with real answers and straight forward communication. The site is very focused on the user experience and visitors have an option to customize the site to meet their needs. This to me is what a great website is all about.
What I really like about the getbcfacts.com website is the way the information is presented to visitors. The site navigation is very easy and is intuitive which frankly you don't see that much in pharma websites. Visitors can get information on a wide variety of subjects from diagnosis to treatment options. There is even some information on clinical trials for people that maybe interested in working with a physician to test new pharmaceutical products.
Where I think the site really excels is the
customization or personalization feature within the
site. Users are guided by a video to enter
information about themselves and then they are
presented with information relevant to their profile
(obviously the folks at Astra Zenca get it). We need
more of these type of websites to educate and inform
a public hungry to research health issues on the
Internet. The only issue I had with this site is that
I was served the ad while surfing the Internet and I
am sure that I am not in their target audience. They
maybe able to do a better job of targeting these ads
online.
It looks like there is a potential battle brewing in the multi-billion dollar prescription cholesterol market. Vytorin has fired the first shot with the results of head to head clinical studies against market leader Lipitor. A three-quarter page ad in todays Wall Street Journal with the headline saying that "Vytorin was clinically proven to lower bad cholesterol more than Lipitor alone". They also show a graph that indicates that Vytorin lowered bad cholesterol by 53% compared to 45% for Lipitor alone. It seems the battle lines are drawn.
Merck and Schering-Plough are promoting the head to head clinical studies on their health care professional and consumer websites as well. The key question is will it be enough for patients to ask their physician or will Vytorin become a second line statin for people whose high cholesterol doesn't respond to treatment with Lipitor? I believe that this battle is going to be fought in the doctors office not with patients. Pfizer has done a great job in promoting Lipitor with physicians. Pfizer is promoting clinical studies that show that Lipitor may reduce the risk of major CV events by almost half. In addition Pfizer is firing back with three key points; lower LDL reductions, outcomes such as stroke reduction of 48% and nonfatal MI reduction of 45%, safety and experience and finally health care access "available for 94% of patients with managed care coverage.
Will these work? Hard to tell, Pfizer tried some of
these tactics when Viagra faced competition from
Cialis and Levitra and they didn't work that well but
the ED market is mostly a patient/consumer driven
market. Pfizer does a great job of bundling their
products to managed care plans and that might give
them a slight edge but the real question is will
patients ask to be switched and will physicians
switch patients? My guess is that patients currently
taking Lipitor and responding to treatment will not
ask to to switch to Vytorin. Why should they? Either
way it will be interesting to see this battle unfold
in the multi-billion dollar cholesterol war. Pfizer I
am sure will not allow this attack to go
unchallenged.
A
key message to HCP's on Lipitor
As
you can see Pfizer is hitting back to Vytorin's
challenge with this
message on the Lipitor HCP
site.
Another year is about to enter the books as history and I believe that that that the future of DTC advertising is needed more now than ever. I believe that there is value in DTC advertising. It allows me to make better and more informed choices when it comes to my healthcare so that I don't always have to rely on my physician. I can work with her to chose the medication that I believe will be best for me.
I love the challenge of DTC marketing in an era when more and more boomers are reaching ages when they are going to require more Rx's to help them maintain a better quality of life. Even when I was marketing Cialis I believe, as I still do, that it's the best treatment for ED on the market. Although lifestyle drugs have gotten somewhat a bad rap in the press they play a role in bringing people closer together. I remember ,during some qualitative research with women (partners of ED suffers), how one person in particular made me realize the importance of what we do. Her husband had ED due to diabetes and they had not had intimate relations for over a year. After dealing with some internal issues (i.e. "it's my fault") she finally talked him into going to see their doctor and ask for Viagra. She planned a special weekend away and rented a cabin in the woods and had arranged for relatives to take care of their children. When her husband came back from the doctor he came back empty handed because he was too embarrassed to ask their physician for an Rx for Viagra. When she told this story there was pain in her voice and you could clearly see that the lack of intimacy was having an effect on her and their marriage. That is when I learned that ED is not just a mans condition but a couples condition and I wanted to do as much as possible to reach these people to try and communicate this along with steps they could take to address this issue together.
DTC marketing at its best can provide answers to both the physical and emotional aspects of health problems. At its worst it can be intrusive and overly promotional but I believe that most DTC marketers can find that balance. DTC marketers have to believe in what they do and what they are selling. You can't take someone who used to work for Coke and put them in a DTC marketing position and expect them to excel, at least that is what I believe. When you ask yourself "what am I selling?" the answer should always be "hope and health". We're not selling purple pills or blue tablets..we're selling a better quality of life and that is what America's pharmaceutical companies need to communicate to the public.
There will be no doubt that changes are in store for DTC as we approach another year. We have a new head of the FDA who must take an agency under siege and prioritize issues facing the public with a newly elected skeptical Congress and House. Vioxx litigation continues in the news and the recent series of story on Lilly's Zyprexa are all sure to keep the media spotlight on the pharmaceutical industry. Maybe I am an idealist but I will continue to believe that DTC marketing is an essential strategy for reaching consumers. I will continue to develop DTC programs that provides answers and as I develop and implement these program I will do so just as if my patients were looking over my shoulder because in the end it's all about them not us..
It seems that the New York Times is on a crusade against Lilly. Again, in today's Business section is another article on Zyprexa and the data that Lilly had collected in early clinical trials relating to weight gain in patients. Once again this is from internal correspondence released by a lawyer in Alaska is who currently is in litigation with Lilly over Zyprexa. It's time for Lilly to stop hiding their head in the sand and come up with an action plan to counteract all this negative publicity on a drug that helps millions of people.
Here is an action plan that I would put in place if I were in Lilly's shoes:
1. Invite the reporter who wrote these articles, along with his editor, to Indianapolis for a meeting. At this meeting I would address each "allegation" one-on-one with open honest responses. For example, Lilly might to point out that some people from the Zyprexa team were terminated for actions that Lilly felt "were not keeping in traditions with our compliance policy".
2. I would then invite the reporter to one of Lilly's compliance training programs which are held quarterly.
3. I would then ask the reporter to interview some family members of patients who are currently on Zyprexa so that they can asses the impact this medication has had on a patients quality of life.
4. Finally; I would let the reporter meet with current members of the Zyprexa team and interview them one on one if necessary.
Are these risky? Yes they might be but in this age of media spotlights and 24/7 information Lilly can't afford to hide behind statements like "no comment" and "we don't comment on pending litigation". That went out the door when the attorney in Alaska released this confidential information. Unless America's pharmaceutical companies take the offensive once in a while they are going to continue to get kicked around like an old shoe. Time for the industry to speak up and talk about all the positive things we do.
According to IMS Health DTC spending in 2005 was $4.2 billion while DTP spending was $7.2 billion. Although a majority of dollars are still being allocated to DTP spending DTC has been growing by leaps and bounds. Although my colleague John Mack in his Pharma Marketing Blog thinks that DTC advertising will overtake DTC I don't think that will happen
I believe that some drugs may launch with huge DTC budgets of $100 million or more but that will be an exception rather than a standard. There is just too much inefficiency in mass media to justify those types of budgets. TV costs are increasing at a time when marketers are questioning its effectiveness in driving brand objectives. Just look what happened in the ED wars. There was a time when Cialis, Levitra and Viagra commercials were all over TV, now they are far and few between. Other brands like Enbrel, and their horrible DTC spot with lethal side effects, don't have the dollars to sustain a heavy DTC media plan.
Why is this happening? Because in the phrama matrix
business environment every dollar that you want has
to be justified with an ROI model. It's getting
tougher for marketers to justify huge budgets when
share stays flat or only rises a couple of points. In
addition there is ongoing research that shows that
patients still rely on their physicians
recommendations for medications. I think that we will
also see a shift in media spending to more efficient
channels like the Internet. The Web can reach more
people at a better cost effective model and it's easy
to measure the impact of the dollars
spent.
DTP
spending growth will level out in the near future for
several reasons. First, pharmaceutical companies are
reducing the size of their sales force. They have
come to realize that they can't have 3 reps calling
on the same doctor. Physicians are also too busy to
see sales reps these days. The average time with a
pharmaceutical sales rep continues to decline and
more and more physicians are using eCME or eDetailing
to get information on new pharmaceutical products.
Finally the pharma industry is going to have to think
about the reps that they recruit. Most are right out
of college and go through training that teaches them
the best way to "pitch" the product. If a HCP wants
to talk to someone in depth about the compound he or
she usually has to find a medical liaison person who
more often than not does not have the information the
HCP wants.
DTC
advertising will continue to play an important role
in the brand mix but marketers are going to have to
learn to do more with less. Today's time pressed
consumers just don't have the time to sit through
your message anymore and it's going to get harder to
cut through the clutter with relevant messages. Still
there are some marketers that will continue to think
in "old school" marketing and request a huge media
budget to launch new products but when the numbers
roll in share had better be tied to the dollars that
were spent.
I guess the NY Times has a bone to pick with Lilly and the pharmaceutical industry. Again Lilly was featured in a front page story about Zyprexa. This time it reported on Lilly's attempts to promote Zyprexa with for off label use. I was not on the Zyprexa team at the time but what the Times failed to report is that the people who were responsible for this poor judgement are no no longer with Lilly. They were shown the door a long time ago and, now it seems, for good reason.
I really don't understand how a national newspaper as respected as the NY Times could be so one-sided in reporting a story. The information that they are reporting was again given to them by a attorney in Alaska who is no doubt trying to cash in by forcing Lilly into a settlement. Lilly already settled most of the lawsuits with a $700 million payment but there are still some lawyers who want their big payday from the pharmaceutical company based in Indiana. What these legal people don't understand is that Zyprexa may have helped millions of mentally ill people lead better lives. It may have eased the burden on society for some people that otherwise might have to be institutionalized. These so called legal people reach out to patients but it is they who will reap the majority of the rewards not patients.
If the reporting in the Times is accurate than in fact several people did use extremely bad judgement in the marketing of the product. A lot of the Zyprexa team people were shown the door and Lilly cleaned house in the brand team a while back. I don't know where theses marketers wound up but I can assure you being fired from a pharmaceutical company is not something you want on your resume.
There are always two sides to every story and instead of the Times sitting down with Lilly with the documents they had in their possession the Times chose to run this story on the front page. So much for balanced reporting. They did contact Lilly and asked them to "comment" but what's the use when you know the outcome is going to be negative. I have a relative who is on Zyprexa and he is doing very well and working full time because of this medication. That is a blessing to family members because the stress of caring for him has affected their well being as well. He has not gained weight and has not had issues with his A1C but you won't hear about that you'll only hear about the people who gained weight and may have become diabetic as a result.
The media reporting in this country has really gone down hill. They seek headlines rather than fact....they don't research stories and the news is more about sensationalism than facts. That's a shame because as a former Lilly employee I was always were told to put patients first and I observed this in the development of a lot of our marketing materials. Like one Director of Lilly taught me "always work like patients are looking over your shoulder". There are a lot of good people at Eli Lilly and they deserve a better more balanced story than the one running in the Times. It's a shame that one of the best newspapers in the world has had to stoop this type of journalism but then again it's about selling papers isn't it?
* I should note that the author of this BLOG used to be an employee of Eli Lilly & Company
This is a week when a lot of people in the pharma industry take vacations but I have a feeling that there will be a lot of important meetings at Lilly's headquarters in Indianapolis this week. As if Lilly, and the whole phrama industry, didn't have enough problems the front page of todays New York Times has an article on Lilly's alleged attempts to play down the risks of its top selling drug Zyprexa. These allegations came from documents — which include e-mail, marketing material, sales projections and scientific reports — and they are replete with references to Zyprexa’s importance to Lilly’s future and the need to keep concerns about diabetes and obesity from hurting sales. Is this really new news or is it a well timed leak from an attorney who still is in litigation with Lilly on Zyprexa and wants to put more pressure on the Indianapolis pharmaceutical company?
According to the article in todays Times;
The documents, given to The Times by a lawyer representing mentally ill patients, show that Lilly executives kept important information from doctors about Zyprexa’s links to obesity and its tendency to raise blood sugar — both known risk factors for diabetes. Lilly’s own published data, which it told its sales representatives to play down in conversations with doctors, has shown that 30 percent of patients taking Zyprexa gain 22 pounds or more after a year on the drug, and some patients have reported gaining 100 pounds or more. But Lilly was concerned that Zyprexa’s sales would be hurt if the company was more forthright about the fact that the drug might cause unmanageable weight gain or diabetes, according to the documents, which cover the period 1995 to 2004.
A couple of things about this story seem fishy to me. First, The Zyprexa documents were provided to the Times by James B. Gottstein, a lawyer who represents mentally ill patients and has sued the state of Alaska over its efforts to force patients to take psychiatric medicines against their will. Mr. Gottstein said the information in the documents raised public health issues. Second, the release of these documents maybe illegal given the pending litigation of continued Zyprexa lawsuits. This, to me, seems like a well placed story by a savvy attorney who wants to pressure Lilly into a settlement that will, in all likelihood, support a win and of course monetary collection of fees.
As I see it there are a couple of issues here:
1. Did Lilly try and hide Zyprexa's side effects (weight gain) from health care professionals because they didn't want to hurt sales ?
2. Are health care professionals responsible to monitor patients for possible side effects when they start them on new medications?
This author worked for lilly for almost 5 years and during that time, as an employee, I was required to attend quarterly compliance training to ensure that I was aware of marketing compliance guidelines for both health care professionals and patients. I believe that these documents are being taken out of context. Zyprexa may have helped thousands of mentally ill patients lead better lives and be more productive to society. In addition isn't it the obligation of a prescribing physician to monitor patients while they are on prescription medications? The biggest pharmaceutical product in the world, Lipitor, for example requires that physicians monitor patients while on the medication to ensure that liver damage does not occur.
If anything maybe Lilly should have included a stronger warning to health care professionals about the weight gain issue and to monitor patients weight while on the compound. I just don't believe that in an age where every marketing message is archived that Lilly would have tried to hide anything or risk patients health for sales dollars.
Of course decisions like these are made ordinary business and medical people and sometimes they can chose the wrong path despite the efforts to keep patients best interests at heart.
Regulators are issuing fewer citations to drug companies for false and misleading advertisements and are taking longer to do it, a congressional report says. DUH ! With direct to consumer advertising over $4 billion and increasing and a small staff of reviewers just what is the FDA supposed to do?
From 2002 through 2005, it took the Food and Drug Administration four months on average to draft, approve and send warning letters and other correspondence to companies that were in violation of the rules, government auditors said. Between 1997 and 2001, before FDA lawyers began reviewing the letters as a matter of policy, it took two weeks on average to issue the letters. The number of letters fell off by about half between the two time periods.
The Government Accountability Office also said the FDA lacks an effective way to screen, review and track the more than 10,000 ads and Web sites brought to the agency's attention each year. The amount has doubled in four years.
The Health and Human Services Department, the FDA's parent agency, acknowledges that the FDA's six reviewers can't scrutinize everything so they focus on those ads with the greatest potential to affect public health. The department said the lengthy legal reviews give the FDA more teeth because the letters that are sent rest on a more solid legal foundation. "As a result, companies take our letters more seriously and quickly react to the problems identified therein," the department said in written comments to the GAO, the investigative arm of Congress.
Will this lead to more reviewers? Probably not but you can be sure that when Democrats take control of both houses that this report will be used against the FDA. The new head of the FDA is sure to be called in front of Congress to explain the the FDA's lack of oversight of DTC ads and websites. Changes are in store but for now the direction and scope of those changes are anybody's guess.
There is a good analysis of the strengths and weaknesses of Lilly's potential long term strategy in today's Wall Street Journal. Zyprexa, Lilly's biggest product, is coming off patent in 2011 and Lilly is looking to its pipeline to replace lost Zyprexa sales. Will this strategy work? That's a good question but this author believes that Lilly maybe aware that the days of blockbuster drugs are coming to an end.
Cymbalta has had a tough time achieving the blockbuster sales status of Prozac. It seems, in order to cut costs, research is being circulated that shows that Cymbalta may not be any better at treating depression than of Fluoxetine ( generic Prozac) which is a lot less expensive. Zyprexa is also under attack with similar research studies and it's feasible to think this trend will continue as insurers look to cut the costs of prescription drugs. When I was prescribes Celebrex, for example, for my shoulder my health provider sent me a letter stating that OTV Ibuprofen was just as effective as Celebrex and a lot less expensive.
The new drugs in Lilly's pipeline do look promising
but as Pfizer learned the hard way there is always
some risk in the development of new
drugs.
One of the new drugs in development at
Lilly is
Prasugrel, a blood thinner which Lilly hopes can
rival popular Plavix. This product does have risks
and let's hope that Lilly is not too dependent on the
success of Prasugre. According to today's WSJ:
The drug appears to create a greater risk than Plavix of causing bleeding in patients, a potential side effect since blood thinners inhibit clotting. The drug faces greater scrutiny and a tougher environment for clinical trials in light of recent disappointments from Nuvelo and Bayer AG, whose jointly developed blood thinner failed to meet targets in late-stage tests, and Pfizer's decision to stop developing the good-cholesterol drug torcetrapib. Lilly also will have to split prasugrel profits with Japanese partner Daiichi Sankyo, making the drug even "less of a long-term earnings driver for Lilly.
The analysis of the Lilly in today's WSJ is good but it's not a thorough analysis which is what I have come to expect from newspapers. In addition to the drugs in the pipeline you also need to take a look at the people who will market these products. Lilly has never been known as a marketing powerhouse and they are going to need marketers with a lot of skill to market products in this era of increases scrutiny and consumer power. One thing is for sure there is a lot of uncertainty at Lilly and in the whole pharmaceutical industry. Lilly will survive and may even prosper but they may have hit a ceiling in overall sales growth. For a while they may just be a $10-$12 billion profitable pharma company with a diversified portfolio and that is fine in the new economy where blockbusters may be few and far between.