Last week's ePharma Summit was held at the new Borgata Hotel and Casino in Atlantic City, NJ. This venue, it turns out, was appropriate as many presenters and diehard attendees -- of which there were disappointingly too few -- seemed to be gamblers of one sort or another. Some gambled at the tables in the casino and some are gambling that pharma e-marketing will take off in 2005.
David L. Stern, Vice President of Marketing for Metabolic and Endocrinology at Serono, Inc., speaking at the conference declared that "pharmaceutical e-marketing is at the tipping point." He noted that one of the challenges for pharma is the segregation of e-marketing from other forms of marketing. "Marketing is marketing," he said.
e-Marketing indeed is a challenge for the pharmaceutical industry and I have long claimed that the percent of the pharmaceutical marketing budget spent in the "e" space has remained below 5% since 1998 when I first got involved with pharma e-marketing in the heyday of the dotcom boom (see "What Stands in the Way of the Mainstream Use of the Internet by Pharmaceutical Companies?").
Stern and other presenters called for breaking down the "marketing silo" mentality of pharma companies and the integration of e-marketing with other forms of marketing.
The problem is that after years and years of consultants and e-marketers inside and outside pharma telling brand managers that the Internet is different, special and the greatest thing since sliced bread and, by the way, better than TV or print, they are now saying essentially "why can't we all just get along?"
I agree that the Internet is different. It is more interactive, more measurable, and more targeted than print or TV. e-Marketing uses special marketing techniques and requires a special knowledge that many "traditional" marketers may not have.
But, it is not better -- at least not better for achieving every marketing goal. TV, for example, is much better at reaching large numbers of consumers. Pharma product managers may have the mistaken notion that the Internet is an awareness medium like TV and print and they may hold it up to the same ROI standards used to measure traditional awareness media. Early proponents of the Internet may be partly responsible for perpetuating this view. However, the Internet is a poor awareness tool - it's nearly impossible to reach a big enough audience of a particular segment online without a massive ad campaign across multiple sites. For awareness, TV beats the Net hands down.Online media haven't offered the reach numbers to justify the bigger budgets - for media planners, it's near impossible to find x million consumers of a particular segment anywhere online (without a massive effort to connect dozens of small sites), and that's what brand managers need to move their share graphs. -- Jack Barrette (see PHARMA-MKTING discussion thread "What's the % of DTC budget spent online?").
So, is e-Marketing at the tipping point and ready to take off in 2005?
Several experts at the ePharma Summit pointed to the new DTC ad policy of BMS (see "New DTC Principles Emerging") as validation of this view. They point out that while BMS will refrain from running DTC ads on TV during the first year after a drug launch, it's policy makes a point of not including interactive media in the ban and suggests using the Internet for more disease awareness and product advertising. See Bristol-Myers Squibb Direct-to-Consumer Communications Code.
This non-mention of the Internet is faint praise indeed.
I think some pharma e-marketers are grasping at straws and it will be an uphill battle to move the share of pharma marketing budgets out of the single digit range. This view was strengthened as I looked at the ePharma Summit audience. I counted only about 70 people at the meeting, which in the past would have up to 400 attendees!
Also, many people who had executive positions as e-marketers in pharma companies have been laid off during the past several years. These people were the first to go when their companies merged. Either no new people took their places or the ones that did don't even know what search engine optimization is.
Despite some surveys that indicate that 2005 will be a good year for DTC e-marketing (see, for example, "DTC in 2005: Can You Teach Old Dogs New Tricks?"), I believe e-marketing will always be an extremely small (less than 5%) part of the pharma marketing budget. If you are interested in why I believe this, see "What Stands in the Way of the Mainstream Use of the Internet by Pharmaceutical Companies?" What I said then is even more true today when all forms of DTC advertising and communications are being carefully scrutinized by the FDA and other watchdogs.
IMHO
The FDA Office of Drug Safety has a HELP WANTED sign in its window:
New Leadership for Safer Drugs
The Office of Drug Safety announced a nationwide search for a new director of drug safety (DDS) with the Food and Drug Administration.
[Acting FDA Commish Lester Crawford was heard commenting: "A director of drug safety has got to be found somewhere. Any DDS's under the desk? Nope, no DDS's there!"]
The DDS will be in the center of a whirlwind of special interests with huge financial stakes at risk in the safe and appropriate use of medications. These interests will make mincemeat out of this grade 15 federal bureaucrat with a salary somewhat higher than an average drug rep and whose impact on the future of public health is dubious at best.
The DDS office, a fortified subterranean bunker, is located in the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) in Rockville, Maryland.
Duties of the position include: - leadership of the agency's drug post-marketing risk assessment operations. In this capacity you will be supervising about 2.5 FTEs.
- working closely with stakeholders inside and outside the Federal government. You'll hobnob with the likes of Billy Tauzin, president of PhRMA. He's pretty familiar with Washington and will introduce you to all the right people. You will also work with the Drug Safety Oversight Board. But don't worry, the vast majority of Board members are fellow bureaucrats form the FDA. There won't be any citizen representatives on the Board to give you a hard time. Oh yes, you'll also work with members of Congress who are really are a pain in the butt, but what can we do?
- developing and maintaining international and national contacts with regulators. The UK regulators are really a fun group although they have a tendency to upstage the US and withdraw dangerous drugs at the drop of a pin, if you know what I mean.
- implementing policies and initiatives related to adverse drug events and the Medwatch program. You are not to touch this voluntary system and try to make it more effective in any way! We don't care that HHS Secretary Mike Leavitt suggested using the emerging technology of the National Health Information Exchange to track drug adverse events (see article "HHS: Drug safety reporting system could be prototype for health data exchange" and his speech at a recent Health Information and Management Systems Society Conference). A knowledge of computers and the Internet is NOT a pre-requisite for this job.
- representing FDA and CDER in scientific and regulatory matters related to drug safety. Yeah, you'll be the guy sitting on the hot seat before congressional committees like that pesky Health, Education, Labor, and Pensions Committee.
Qualifications
"The position requires a medical doctor..."
[I think they mean the candidate has to be a medical doctor, not that the DDS will need a doctor after being on the job for a day or two; a Doctor of Osteopathy is also OK, even from a school in Canada where all those dangerous drugs are being imported from, although I hear the Canadians will soon put a stop to that nonsense! (See "Canada to ban bulk drug sales to U.S."). If so, and if the drug industry is right about the danger of importing drugs from Canada, your job should be much easier and you will hardly need to work at all for the "103,947.00 - 180,100.00 USD per year" that the FDA will pay you.]
Just to be on the safe side and satisfy our legal department, you will also need advanced knowledge of epidemiology, public health issues related to drug safety, and risk management.
FDA officials worked with the US Office of Personnel Management on a rigorous job analysis and to develop the selection process for this high-profile position.
Those interested can find more details and an online application at the USAJobs Web site.
The Washington Legal Foundation (WLF), a conservative watchdog group funded by businesses (including drug companies), last week launched the "FDA/DDMAC Watch" program to "scrutinize" FDA advertising regulations. DDMAC is the FDA's Division of Drug Marketing, Advertising, and Communications, which oversees drug ads.
DDMAC Watch's first action challenged an FDA warning letter regarding a TV ad for Eli Lilly & Co.'s adult ADD therapy, Strattera (see "Watchdog Group Blasts FDA").
According to the WLF, the FDA is acting “"outside its legal authority"” when its writes such letters, and shows "“disregard for the First Amendment by alleging that materials are misleading with no evidence of how consumers understand them." ” (See the WLF Letter to DDMAC).
In short, the Washington Legal Foundation claims, the FDA "“invented" much of its power to police drug advertising. ("Watchdog Group Blasts FDA").
WLF is to the first amendment what the NRA is to the second amendment. That is, every argument by WLF begins and ends with the first amendment as it applies to a special interest group -- i.e., businesses like the pharmaceutical industry.
The House(s) That Troy Built
What's really interesting, however, are the ties that bind WLF, FDA, and the Pharma industry.
One of the main ties is Daniel E. Troy, former chief counsel to the FDA who joined WLF's board of directors just 4 days before the DDMAC Watch letter. According to the WLF Web site, Troy was "the first appointee to the Food and Drug Administration made by President George W. Bush."
"Troy managed to restrict FDA's ability to use its statutes creatively, and this in turn deterred mid-level managers from advocating new approaches to emerging scientific issues, leaving the agency looking - and feeling - weak." (See "FDAers Think Troy Weakened Them, Worry About Masoudi").
Before his stint at the FDA, Troy repeatedly sued the FDA. He argued that the FDA had only limited ability to regulate drug companies. Troy filed those suits through --- you guessed it -- the WLF! He also did legal work for Pfizer. Oh well, just another case of "What goes around, comes around."
What About Those Warning Letters?
The WLF criticism of the Strattera warning letter, which I will get to in a moment, comes at a time when the FDA is sharply increasing the number of warning letters sent to pharmaceutical companies.
The FDA issues two types of letters: untitled letters or Notices of Violation and warning letters. The warning letter goes to the CEO and essentially says "we think you have really screwed up and in a way that we think is important to the public health and we expect you to put out some kind of additional information to correct the misinformation you sent." (I quote here John Kamp, Executive Director, Coalition for Healthcare Communication. Kamp was speaking at a CME conference in Princeton, NJ.)
An untitled letter is sent to the head of marketing and says "we think you have a problem, let's sit down and work something out." This type of letter is much less serious and effective than a warning letter. In fact, I've heard it said that untitled letters are considered rites of passage by pharma product managers, who frame them and hang them on their office walls. That's what I've heard some people say.
According to the Philadelphia Inquirer ("Deluge of drug ads has FDA struggling to stop the hype"):
In January 2002, the Office of the FDA Chief Legal Counsel, Daniel Troy, began reviewing the evidence behind all proposed enforcement letters with an eye toward scuttling any that might not hold up in court. Claude Allen, the deputy secretary of the Health and Human Services Department, the FDA's parent agency, ordered the change in policy.
Troy effectively hobbled the issuance of warning letters by the FDA.
An October 2002 study by the General Accounting Office, the investigative arm of Congress, said that, before Troy's reviews began, FDA notices went out within days after a problem ad was spotted. Under the new policy, clearing the letters took 13 to 78 days, the report said. "Some regulatory letters may not be issued until after the advertising campaign has run its course," the GAO found. (Phila Inquirer)
While the number of total enforcement letters sent by the FDA has hovered around 23-25 in the last three years, the number of warning letters increased dramatically in 2004 (before Troy left the FDA but during the VIOXX debacle). In that year the FDA issued 12 warning letters compared to 5 in 2003 and 1 in 2002. 2005 promises to be a record year -- already nine warning letters have been issued.
The FDA may be getting the impression that the drug industry is not listening. According to Kamp, "DDMAC is saying the same things over and over again [in warning letters], but the industry is just not getting it. FDA is turning up the heat. How much higher, might I add, does it have to get before we start paying attention?"
If the WLF represents the pharma industry -- and with Troy involved it's hard to dispute that it does -- then the industry is paying attention, but responding by criticizing the FDA. There has been some more positive response as well. Recent DTC policy changes by J&J and BMS come to mind (see "DTC Straight Talk" and "New DTC Principles Emerging").
So What's the Beef With the Strattera TV Ad?
The FDA had asked Lilly on June 14 to pull its Strattera TV ad on the grounds that the flashy graphics made the warnings on side effects too difficult for consumers to comprehend (see warning letter and "Watchdog Group Blasts FDA").
WLF had this to say:
"DDMAC cites no evidence demonstrating that consumers cannot process the information presented in the advertisement. In fact, the TV advertisement conveys its message regarding attention deficit disorder so many times that it is incomprehensible that consumers would miss it. The sole source of authority for DDMAC's allegations against Lilly is the individual judgment of the DDMAC reviewer who signed the letter."
I don't recall seeing the ad myself, but the FDA presented promotional material, submitted by Lilly, which included screen shots from the ad. It looks distracting to me. I don't think you have to do a scientific study to tell whether or not an ad is effectively presenting labeling information. To suggest that "evidence" be produced is merely a ploy to delay the process so the ad can run it's course.
The problem is that the review by the FDA happens after the ad is already produced and running. It would be better, as proposed by BMS, that DTC ads be submitted to the FDA for approval BEFORE they run (see "New DTC Principles Emerging").
Guidance Needed
There is at least one point made by the WLF that I can agree with. It has to do witrh guidance from the FDA regarding TV DTC ads for Rx drugs:
"DDMAC should start providing concrete guidance to industry to help them fulfill this objective and stop playing 'gotcha' with drug companies," said WLF Chief Counsel Richard Samp.
Maybe Samp has a point. While the FDA has issued guidance regarding print DTC ads (see "Future of Drug Print Ads"), it hasn't done the same for TV DTC ads. Perhaps that will come sooner than Samp would like.
Last week I received a special edition of Newsweek Magazine devoted to "The Future of Medicine." The issue touted new treatments coming our way in the 21st century.
Unfortunately, the drug ads in the magazine were still locked into late 20th century thinking.
Take the 2-page ad for Topamax, a migraine (headache) treatment. Nice ad, most of which was occupied by a huge photo of three women yukking it up in a beauty salon. Along the bottom half-inch of the ad, in type of similar size to most of the body type, was "Important Safety Information," or what the industry calls "fair balance."
In the 21st century drugs will still have risks, despite the rosy pictures of the future depicted in Newsweek. (One such picture is a little freaky. It shows a mom of the future, all decked out in futuristic hairdo and clothing, handing her teenage daughter what appears to be a magic pill, which positively GLOWS. Everyone is smiling.)
No pharma company today would employ such spooky imagery to promote their products. Ads are about the promise of the product, not the product itself. That's why the Topamax ad shows happy people free of migraine.
Anyway, I digress. Back to the fair balance at the bottom of the Topamax ad. The text ends by saying: "Please see brief summary of full Prescribing Information on next page." What you see when you turn to the next page is this:
This is what's called the "brief summary." It has often been said that the brief summary is neither brief nor a summary. You can tell that just by looking at the image.
Note: the area highlighted in the image is enlarged below to give you some idea of the complexity of the language:
CAN'T READ IT? IT DOESN'T MATTER. YOU WOULDN'T UNDERSTAND IT. BELIEVE ME.
Back in February 2004, the FDA issued long-awaited draft guidance documents designed to improve communications to consumers (see "FDA Draft Guidance for Print DTCA: Less than Feared").
The draft guidance "Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements" encourages manufacturers to use clearer, less cluttered formats for presenting risk information and encourages them to focus their risk disclosures on the most important and the most common risks and to do so in language easily understood by the average consumer.
In print ads, pharmaceutical companies have traditionally satisfied the brief summary requirement by including the entire professional package insert on a separate page. This is precisely what the Topamax ad does. I shouldn't single out Topamax because other Rx DTC ads in the magazine followed the same basic pattern.
The Future of Drug Print Ads
How nice it would have been for drug companies to show us DTC ads of the future alongside the futuristic editorial visions in the Newsweek special edition! What this would look like can be imagined if drug companies followed FDA guidelines summarized below.
In place of the requirement for a brief summary, the new FDA guidance allows the following options for providing risk information in ads: - FDA-Approved Patient Labeling -- This is sometimes called a patient package insert (PPI), which is specifically designed to be consumer friendly. Some companies -- e.g., Merck -- already use PPIs in their print DTC ads. Generally, FDA-approved patient labeling does not address each specific risk included in the professional labeling. FDA states "We believe that omitting less serious, infrequent risks from patient labeling may actually increase the usefulness of this labeling for its audiences by making the more important risks stand out more clearly."
- Highlights -- A proposed new section of the professional labeling, Highlights have been under consideration by the FDA since 2000."“Ideally," says FDA, "the Highlights would be translated from language appropriate for a professional audience into language easily understood by the average consumer."
The draft guidance also allows advertisements to present key risk information in the main body of the advertisement if the data is put in bullet-point format within a "risk information window," rather than in the text.
Prevention & Men's Health Magazine's 1999 DTC Study revealed that among consumers who recall DTC ads in print, almost half (46%) don't recall the brief summary at all and of those that do, only 12% read it thoroughly. Considering the brief summary example above, it's a wonder that 12% claim to read this stuff!
The industry has to do a better job of communicating risk, especially if it claims that all drugs have some risk and it is up to the consumer to balance risk and benefits. With risk information presented in the old-fashioned 20th century way, there is a better chance for a snowball to survive in hell than for a consumer to learn as much about risks as benefits from DTC print ads.
Taking "One small step for a pharmaceutical company, one giant leap for the pharmaceutical industry," Bristol Myers Squibb (BMS) announced on 13 June 2005 that it will refrain from direct-to-consumer (DTC) advertising for a minimum of 12 months following the launch of a new drug (see "BRISTOL-MYERS SQUIBB ANNOUNCES NEW DTC POLICY"). It will also limit advertising on TV to "appropriate audiences at appropriate times."
BMS should be congratulated for implementing this new policy.
Of course, this action comes amid increasing criticism of DTC advertising from a number of sources (see, for example, "The End of DTC as We Know It", "DTC Laissez-faire: A Bankrupt Policy", and "Blame the Doc, Not DTC!").
Upstaging PhRMA?
BMS may also be upstaging its rivals by anticipating voluntary DTC guidelines currently being developed by PhRMA (the industry's trade association). The New York Times reported on 17 May 2005: "The chief lobbyist for the pharmaceutical industry said Monday that drug companies were trying to develop a voluntary code of conduct for the advertising of prescription medicines on television and in print. The lobbyist, Billy Tauzin, president of the Pharmaceutical Research and Manufacturers of America, said he hoped the standards would be issued by June or July. One purpose is to fend off more stringent federal regulation. Television commercials for some products, including erectile dysfunction drugs, have been criticized by consumer advocates and politicians and mocked by late-night comedians." (See "Drug Industry Is Said to Work on an Ad Code").
I've been told by someone close to the industry and PhRMA that this voluntary code would not likely be ready before the end of the year. Perhaps the BMS announcement will goose the process along.
New DTC Principles Emerging
The announcement by BMS and the new approach to DTC advertising taken by J&J (see "DTC Straight Talk") begin to shed light on principles that the pharma industry will ultimately adopt for DTC advertising. So far, these principles are: - Delay DTC for 1 Year After Launch. Refrain from any direct-to-consumer branded mass media (television, radio and print) advertising to promote a drug for a minimum of 12 months following its launch.
- Put Limits on TV DTC. When a drug is advertised on television it will be to appropriate audiences at appropriate times of the day.
- Submit to FDA for Prior Review. Proposed DTC advertisements will be submitted to the Food and Drug Administration for advisory comment once a decision is made that advertising for a new medication is appropriate.
- Balance Benefit & Risk Information in DTC. DTC ads will put drug risks on more-equal footing with drug benefits.
For more information about BMS's plan, please see its "Direct-to-Consumer Communications Code."
From an article in today's New York Times ("U.S. to Review Heart Drug Intended for One Race"):
"Scientists believe that genetic markers will someday be found that explain the different reactions to drugs, but for now, race or ethnicity is an imprecise shortcut. By approving BiDil, the F.D.A. would go well beyond where it has in the past in using race as a category to evaluate which patients respond to drugs."
The drug in question is BiDil (developed by NitroMed, Inc.), a heart failure treatment that was rejected by the FDA eight years ago based on studies in the general population. The company now is seeking approval of the drug for use only in blacks based upon a clinical trial involving self-identified African-Americans only (the African-American Heart Failure Study).
For more on this topic, see "'Ethnic Drugs' and 'Genetic Marketing'"
More Than Science at Work Here
A controlled, scientific study is the gold standard. More than science, however, is at play here, which is always the case with pharmaceuticals. Ethics and politics are involved as well as economic factors and marketing savvy. You can read the story yourself.
Good Marketing
Redesigning the clinical study to be able to win approval to market to a specific segment of the population is a novel approach. It may set a precedent. Note that once a drug is approved -- even if just for a segment of the population -- it can be prescribed for anyone. "I don't believe for a second that this drug combination is only going to prove to be beneficial in African-Americans; it's just not conceivable," said Dr. Joshua Hare.
The controversy is likely to generate -- and is already generating -- a lot of press and support from black politicians and cardiologists. So there will be a lot of buzz and viral marketing available to bolster the sales of BiDil if it is approved. Thus the marketing savvy angle.
SURVEY
Please take the Pharma Marketing News Survey to give your opinion on the following questions:
- Is race -- at least for now -- a legitimate category to determine which patients respond to drugs?
- How should pharma companies design clinical trials to support use of a drug in a specific ethnic or racial category?
Click here to take the survey.
You'll be able to see a de-identified summary of the results after taking the survey. I will report the overall results here (with comments) at a later date.
Just when I thought I found a pharmaceutical company -- i.e., Johnson & Johnson -- we could trust to do the right thing (see "DTC Straight Talk," where I praise J&J for taking the lead in a new approach to DTC advertising), I learn that perhaps even that company may have hidden important clinical research data about Propulsid, a popular medicine for heartburn, which has since been pulled from the market.
According to an article in today's New York Times, "Lucrative Drug, Danger Signals and the F.D.A.": Dozens had died and more than 100 patients had suffered serious heart problems by March 1998 after taking Propulsid, a popular medicine for heartburn. Infants, given the drug to treat acid reflux, seemed particularly at risk. Federal officials told Propulsid's manufacturer, Johnson & Johnson, that the drug might have to be banned for children, or even withdrawn altogether. Instead, the government and the company negotiated new warnings for the drug's label - though not nearly as tough as regulators had wanted.
The story offers a striking parallel with how Merck reacted to bad news about Vioxx (see, for example,"Who Should Pay for Merck's Obstructionism?").
I am having trouble reading through to the end of the Times story because I know it's all bad news and I just don't have the heart for it. But mainly I couldn't get past this sentence in the article: The company declined repeated requests to make executives available to be interviewed for this article. In written responses, Johnson & Johnson defended the safety of Propulsid and said that the marketing of the pill was appropriate.
THIS IS WHAT REALLY BOTHERS ME and what I want to talk about.
Drugs are sometimes dangerous and "shit happens" as they say. But why drug companies continue to circle the wagons when shit happens is a bit of a mystery to me (just a bit), especially a company like J&J who led the way regarding transparency and crisis management way back when several people died from cyanide-laced Tylenol. Here's what a commentator in this week's New Yorker Magazine had to say about that: In the early nineteen-eighties, American businesses discovered that they could manage crises, rather than just stumble through them. The gold standard was Johnson & Johnson, whose deft maneuvering, after seven people died from ingesting cyanide-laced Extra-Strength Tylenol, helped create a new and lucrative subset of public relations known as crisis management, which was poised, as Time put it in 1986, to become "the new corporate discipline."
Wha' Happened?
The first thing that comes to mind is lawyers happened -- both inside companies and litigators outside. Which came first is of little consequence. I imagine today that the lawyers inside J&J have put the muzzle on everyone, including the PR people and execs who might otherwise wish to employ the "gold standard" of crisis management.
I've often heard executives of pharma companies say that the industry should have better PR, by which they mean more strident PR touting how great the industry is, how they save lives, yadda, yadda, yadda. Show some backbone, they say.
That's not crisis management and that does not show backbone.
J&J should have their people out there talking to the NY Times, being transparent and managing this crisis not only with words and slogans like "Where patients come first" (see "Patients Come First?"), but with actions!
Obviously, it's a bit late for J&J and they probably can't say it isn't so (the Times allegedly has previously sealed court papers with proof).
What Are They Thinking?
Maybe J&J thinks the crisis that happened years ago, they already pulled the drug from the market, and this is just a rehash of old news that will blow over. So, best to stonewall and stick with the all-too-common "defense": "Our marketing was appropriate."
There's no doubt in my mind that pharma companies recognize that they are in a crisis, but they do not realize that the crisis needs to be managed through transparency and by words backed by action -- that is, by employing the "gold standard."
Back when COX-2's were under fire, representatives of the drug industry lamented that they "can't get any repsect." You might have remembered this bit from the Financial Times:
Pfizer's chief executive said advances in health care could be harmed if the pharmaceutical industry is "demonized." In an interview with the Financial Times, Henry McKinnell lamented the sinking standing of drug makers. "We cure heart attacks and strokes and cancer, but we can't get any respect,” he said.
The pharmaceutical industry is really in trouble -- and, by McKinnell's logic, our health will really be harmed -- if the industry cannot even get any respect from leading Republicans!
Take Senate Finance Committee Chair Chuck Grassley (R-Iowa) for example. He's been giving the industry a hard time and most recently has criticized the new drug safety board established by the Food and Drug Administration (see "Drug Safety Panel Is Criticized").
WHAT DO YOU THINK?
Do you think the Drug Safety Oversight Board proposed by the FDA is independent enough and propoerly constituted with the right mix of experts? Please answer this and a few other questions in this month's Pharma Marketing News Drug Safety Survey.
Here's the letter the Senator wrote the FDA:
Dear Dr. Crawford:
On May 18, 2005, the Food and Drug Administration (FDA) announced the members of its new Drug Safety Oversight Board (DSB). According to the FDA's policies and procedures manual for the DSB, one of the purposes of this board is to provide independent oversight and advice to the director of the Center for Drug Evaluation and Research (CDER) regarding drug safety issues.
The new board, however, is established within CDER and has no authority to pull a drug from the market if it determines that the drug is harmful to patients. Of particular concern to me is the makeup of the DSB. The FDA states that the DSB will "enhance the independence of internal deliberations and decisions regarding risk/benefit analyses and consumer safety." But, I do not believe that this is the case for several reasons. First, a majority of the DSB members are senior managers within CDER, the center responsible for drug approvals. In fact, CDER officials hold 11 out of a total of 15 voting positions on the DSB. Even more interesting regarding the make-up of the board is the fact that only three of the 11 DSB CDER officials come from organizational subunits not directly involved in the review of new drug applications. Moreover, two of these three originally came from the Office of New Drugs, which is charged with getting new drugs on the market in the first place. So, what we have here is nothing more than the status quo. My question to you, Dr. Crawford, is: Where are the people responsible for post-marketing surveillance who have allegiances only to post-marketing safety and the public's well-being and not to the drugs that they helped put on the market in the first place?
In addition, according to FDA Week (May 20, 2005), the FDA announced in early May that the deliberations of the DSB will be private, unlike decisions that are made by FDA's advisory committees. It is surprising to me that the FDA has chosen to make DSB deliberations private at a time when the agency should be making every effort to improve transparency and accountability.
As Chairman of the Committee on Finance, I request that the FDA explain in detail how it will ensure that the DSB is truly independent and objective. In addition, please describe in detail any actions the FDA will take to assure the public that decisions made by the DSB will be unbiased.
I look forward to hearing from you regarding the issues and concerns set forth in this letter and would appreciate a response to my inquiries no later than July 1, 2005.
Sincerely,
Charles E. Grassley
Grassley has introduced legislation that calls for an independent drug safety office:
An independent drug safety office would more effectively regulate drugs once they’re on the market. If you want accountability, it doesn’t make sense to have the office that reviews the safety of drugs to be under the thumb of the office that puts the drugs on the market in the first place. The drug safety office would have an independent director and the regulatory authority to require label changes. (See "INTRODUCTION OF AND REMARKS BY SEN. GRASSLEY BEFORE THE CONSUMER FEDERATION OF AMERICA ON THE FDA AND PRESCRIPTION DRUG SAFETY").
For more thoughts on the FDA and drug safety, see "Proposal for a Drug Risk Advisory System" and "FDA Drug Watch Site Guidelines").
In the movie "Monty Python and the Holy Grail," King Arthur, played by Graham Chapman, fights a duel with the Black Knight, played by John Cleese. It's a pathetic match because King Arthur easily chops off the Black Knight's arms and eventually his legs as well, which the Black Knight claims is only a flesh wound. Here's a bit of the dialog:
Black Knight: Have at you.
King Arthur: You are indeed brave, sir knight, but the fight is mine.
Black Knight: Oh, had enough eh?
King Arthur: Look, you stupid bastard. You've got no arms left.
Black Knight: Yes I have.
King Arthur: Look.
Black Knight: Just a flesh wound.
Peter Rost, a VP of marketing at Pfizer, must be feeling a bit like the Black Knight these days (Pfizer would be the King of course; "It's nice to be the King."). You may have seen Mr. Rost interviewed this week on 60 Minutes where he was critical of the pharmaceutical industry's drug importation policies.
"Pfizer just disconnected my cell phone and disabled access to my corporate e-mail account," Rost wrote in a personal email to friends Tuesday morning (see Marketing Exec Feels Heat At Pfizer).
"I'm not that worried though," said Rost.
Yeah, just a flesh wound!
Rost, of course, "has . . . no substantive grasp of how re-importation threatens the safety of the U.S. drug supply," says Pfizer.
Pfizer may be referring to the supposed threat to our drug supply posed by terrorists. If so, they are playing the terrorist scare card to better silence all critics of re-importation, not just Rost. See "Terror Politics vs Drug Importation" for my thoughts on the unpatriotic tactic.
I call it unpatriotic because it is an attempt to shut down a democratic debate by invoking our fears of terrorism. Also, in so far as this tactic diverts our attention away from real terrorist threats, it makes us more vulnerable.
I attended the recent seminar entitled "Are You Building Brands...Or Relationships?", which was hosted by Lathian Systems, Inc., a provider of eDetailing and other web-based programs for pharmaceutical marketing.
I will be reviewing in more detail a couple of the presentations from this seminar in an upcoming issue of Pharma Marketing News. Here, however, I'd like to focus on just a few things that I learned specifically related to ROI or Return on Investment for eDetailing programs, especially compared to ROI for direct-to-consumer (DTC) advertising.
Let's look at some pharmaceutical consumer and physician promotion ROI numbers.
Keep in mind that the pharmaceutical industry spends massive amounts of money on promoting to consumers and physicians and all this money has spawned an ad and marketing "palace industry" -- as opposed to a "cottage industry" -- that spends an awful lot of time, effort, and money of its own to defend the effectiveness of the products and services it offers its pharmaceutical clients. Therefore, it is quite difficult to reach consensus on ROI and the bullshit level of many estimates is likely to be very high.
DTC ROI
Although there is much controversy surrounding DTC ROI, most published data on ROI for DTC show positive results.
On one hand, one industry expert estimated that ROI for DTCA (direct-to-consumer advertising) is in the range of $1.60 to $2.00 per every dollar invested and some estimates are as high as $4.00 per dollar invested. (See "Key Issues Facing DTC Marketers in 2004").
On the other hand, a study by Dartmouth College concluded that the overall median ROI for DTC was only $0.19 and several brands had negative ROIs! "DTC ROI ranged up to $1.37, depending on brand size/launch date," was the best it could say about DTC (see the "ROI Analysis of Pharmaceutical Promotion" or "RAPP Study").
Needless to say, the RAPP study, which was sponsored by the Association of Medical Publications (not an unbiased entity), is often criticized by pharmaceutical marketers. An IMS study, in particular, countered the RAPP study using a different methodology and concluded that "Seventy percent of the brands analyzed have an ROI in excess of $1.50 for each dollar invested; 35 percent were in excess of $2.50. The best performing brand in the study yielded an ROI of $6.50 per dollar invested." (See "DTC at the Crossroads: A Direct' Hit...or Miss?")
OK, let's split the difference between RAPP's best number of $1.37 and IMS's average of $2.00 and use $1.68 our estimate for DTC ROI.
Physician Detailing ROI
The same RAPP Study concluded that the overall ROI for physician (traditional detailing) was $1.72 (ranging from $1.27 to $10.29 depending on brand size and launch date). I don't have any other numbers for traditional detailing ROI.
eDetailing ROI
Sally Schehr, principal at IMS Health Management Consulting, presented data at the Lathian seminar for one eDetailing case showing ROI to be $2.48. The analysis was done for a Lathian eDetailing program, but IMS has numbers for other programs as well. I will report on this in an upcoming Pharma Marketing News article.
ROI Summary
- DTC = $1.68
- Traditional Detailing = $1.72
- eDetailing = $2.48
So, Why Isn't More Money Being Spent on eDetails?
If the one eDetailing case study proves to be average, then it's difficult to understand why pharmaceutical brand managers do not spend more money on eDetailing (and less on DTC).
It's not that they doubt that eDetailing works. Monique Levy, Senior Analyst at Jupiter Research, presented results at the Lathian seminar from a survey of pharmaceutical executives that her firm conducted in August 2004. Only 16% of the respondents indicated that "low ROI" was a barrier to increasing spending on eDetailing.
What 61% of execs in the survey wanted, however, was proof of ROI. This seems just what IMS is offering.
Another barrier to increasing use of eDetailing that Levy mentioned was the strong traditional sales culture at pharmaceutical companies. Forty-eight percent (48%) of survey respondents cited this as a barrier to eDetailing.
"There is a dichotomy between sales and marketing at pharmaceutical companies," said Levy. "Sales doesn't take marketing seriously. It's often like two different worlds."
Drop the "eDetailing" Moniker
My suggestion for eDetailing advocates is to come up with another name for what they offer.
I always hear advocates emphasize that eDetailing is meant to supplement sales reps, not replace them. Bullshit! And the reps know it is bullshit. The moniker "eDetailing" will always pit the sales rep against the computer geek (and marketer enamored by geeky solutions). With a name like "e-detailing" how can a rep NOT believe his or her livelihood is threatened by technology?
So drop the name. It stinks!
I credit Lathian Systems for re-positioning themselves as "evolving to educate" (see "Beyond the eDetail: Evolving to Educate").
Sales reps want to sell, not necessarily to educate. Therefore, they should not be challenged by "e-Educating" as much as they seemingly are by "e-Detailing."
Perhaps "e-Promotion" might be the best alternative to "e-Detailing;" it allows the distinction between "product education" (promotion) and truly "unbiased" education such as CME.
Whatever you call it, physicians want both kinds of education and they want it at their own convenience delivered in their homes via the Internet.
It's also clear that reps are not good at delivering either kind of education (see "Give Docs What They Want"). Furthermore, reps would probably welcome the opportunity to relinquish the "educator" role and stick to the selling, which they are trained to do, constantly admonished to do, and rewarded well for doing.
In new a new TV ad campaign costing $20 million, Merck proclaims a new slogan: "Merck. Where patients come first." (See the New York Times Story: "A Drug Maker's Ads, Hold the Disclaimer"). I just saw the ad last night. Here's an image used in the ad:
Aw! How cute and cuddly!
The veracity of this slogan might be on a par with other infamous slogans such as "War is Peace" or "Work Makes You Free."
I say this because not so long ago, when Merck was trying its best to hide evidence that Vioxx could cause serious heart problems, it seemed that patients came last at Merck (see Corporate "Moral Values" Anyone?).
A Congressional committee exposed some damning evidence that Merck had a specific program to train its sales reps on techniques for avoiding cardiovascular questions from docs and presenting them with alternative data (see "Is Pharmaceutical Marketing BS?" and "Get a Load of Those Gams!").
What has changed since then?
Merck did get a new CEO, despite the fact that several candidates considered for the position would rather climb mountains (see "John Mack Rebuffs Merck’s CEO Offer"). Could that be it?
Nah! CEOs never know the details -- the better to avoid responsibility (see "Who Should Pay for Merck's Obstructionism?").
Let Employees Speak!
The vast majority of employees and managers at Merck are probably very dedicated people who actually believe in and live by the slogan "Patients come first." Perhaps Merck's corporate communications department and Ogilvy & Mather Worldwide, the agency that created the campaign, are expressing the views of these employees, but I think Merck should let their employees speak for themselves.
Here's what I propose. Instead of a fancy expensive ad campaign with images of "children and puppies", why don't they just interview a few employees and let us hear how they feel? How they want to get back to the Merck they knew when they first came on board. Where they hope Merck will go in the future.
Better yet -- Merck should start a blog and have employees contribute. That might be better than spying on patient blogs, which I hear a few drug companies are doing (see "Drug Companies to Hire consultancy to spy on blogs").
Whether or not Merck will do any such thing, they should hold off on the doublespeak and ad agency dribble until their actions have again proven that patients come first at Merck.
