DIRECT TO CONSUMER ADVERTISING
The case for
This week, the King's Fund hosts another breakfast debate: should drug companies be allowed to promote the use of drugs that can be obtained only through a doctor, on television and in magazines? Is it, or is it not a good thing to have direct-to-consumer (DTC) advertising of prescription drugs?
Proposing the motion is Margot James, Chief Executive of a firm specialising in "international healthcare PR and Communications". Shire Hall Communications are employed by pharmaceutical companies interested in "shaping markets, creating positive perceptions, stimulating demand through both mass and specialist media". For all that's said about great benefits for consumers, this is essentially what DTC advertising is about.
The pharmaceutical industry's arguments for DTC advertising have been well rehearsed. They can point to advertisements that avoid hard sell (much more about the 'disease' than about the drug) and that give useful information to consumers - all carefully controlled by law and, of course, by stringent industry standards and codes. And don't consumers need and want more information about their health and medicines: they've been starved of it in the past, but couldn't they make good use of it to get better treatment now? Would it not patronise consumers, disempower them and violate their rights to know and to choose, to deny them greater understanding? And, anyway, does it make sense to try to stop DTC advertisements - and is it even feasible - when the Internet is already awash with stuff on drugs and health?
Direct To Consumer advertising is at present illegal everywhere but in the USA. Until the 1980's, DTC ads were banned in the US too, but the drug industry lobbied so hard, so cleverly and for so long that the dyke was finally breached. True, many health professionals objected and the US Food and Drug Administration (FDA) hardly welcomed it. But when pornography gets by under the First Amendment of the US Constitution, there was really no way of stopping the market trend - especially not when the TV and press media stood to gain so much from the huge extra advertising spend.
So, now the trickle has become a flood and US expenditure on DTC advertising has gone wild. The watershed came in August 1997, when the FDA relaxed its rules about prescription drug advertising on TV: within a few months, the amount spent on direct appeals to the public exceeded what the industry spent on advertising in medical journals. Last year, IMS Health Forecasts reported that "recent survey results reveal patients' requests for brand name drugs are up 59 per cent" (but since when?) and the upward trend continues today:
DIRECT-TO-CONSUMER PRESCRIPTION DRUG ADVERTISING IN U.S. REACHES $1.5 BILLION FOR TWELVE MONTHS THROUGH MARCH;
LONDON, June 7, 1999 -- IMS HEALTH (NYSE:RX) reported today that direct-to-consumer (DTC) advertising in the U.S. continues its double-digit growth, reaching $1.53 billion for the twelve months through March 1999. This represents a 16 percent growth rate, compared to the 24 percent growth rate recorded for the twelve-month period ending in December 1998. Total promotional spending directed toward physicians and consumers by the pharmaceutical industry totaled $6.14 billion through March, up from $6.10 billion for the twelve months ending in December 1998.(http://imshealth.com/cgi-bin/4wais2 on 12 October 1999)
Whether and how the DTC ad market grows in future will depend ultimately on the perceived return on investment (ROI), i.e. strength of "patient pull" measured as sales growth against competing products, and the ability to maintain a strong price. Otherwise, market size is limited mainly by ability to pay (of consumers and health systems alike) and by the numbers who may be suffering from a DTC marketable disease. Some therapeutic market sectors are not appropriate for DTC advertising. These are said to be the "major impacting factors which together define how suitable a disease is to DTC marketing" - and this is the kind of thinking that goes on behind the scenes:
"the more chronic the disease, the more suitable it is to DTC marketing The high public awareness of drugs such as Prozac has caused a concomitant increase in awareness of depression where there may be mental harm associated with the sufferer's perception of the condition, they may be more inclined to take a lead in the prescription choice . DTC is believed to be most useful for brands where broad awareness is the objective and a big patient population is the target " (Datamonitor press release, 9 November 1998. http://www.datamonitor.com/dmhtml/hc/hcpr119809.htm)
"Techniques for analysing ROI on Direct to Consumer Investment" (Parke-Davis, a division of Warner-Lambert); "The latest wrinkles in DTC regulatory & legal issues" (Eli Lilly & Company), "When in a product's life-cycle do you consider DTC as part of overall brand development?" (Astra Pharmaceuticals) - plus a workshop on "Applied Segmentation & Targeting techniques in DTC marketing". These were the titles of speeches (with speaker affiliation) and a workshop at a big US industry conference on DTC advertising, held in June 1999: (http//:www.srinstitute.com/cs141.html )
"The effectiveness of direct-to-consumer advertising, or marketing pay-back, deals with determining the influence of physician inquiries and ultimate prescriptions written that can be attributed to patient "pull" At Rothstein-Tauber, we have the right tools and the right people to provide well designed and thoroughly analysed research programmes relating to Direct-To-Consumer campaigns." (http://www.rtimarketresearch.com/rt05004.htm)
"CGI Healthcare is uniquely positioned to help its clients establish and protect the value of their products or corporate image because we understand how to seamlessly integrate PR into a marketing mix, including PR campaigns that enhance the return on investment for direct-to-consumer advertising " (
DTC advertising and depression
If this is progress, then the rest of the world is lagging behind the USA - though the writing is clearly on the wall here in the UK. Indirect-to-consumer advertising is already rampant - underpinned by the seemingly endless numbers of important health professionals for hire - and a model (but unrepresentative) DTC advert has just appeared on UK television. It was the perfect foot in the door: it helpfully discussed the problem of incontinence, and studiedly didn't mention a brand name. It just reassured the estimated 50% of sufferers who hadn't been to their doctor, that they should go - "for medical help for a condition that could easily be treated". "This is not advertising, said the director of public affairs at Pharmacia & Upjohn, "this is a health education campaign aimed at encouraging patients to seek the health they need." (BBC News, 17 August 1999.http://news2.thls.bbc.co.uk/hi/english/health/newsid%5F422000/422560.stm )
Even without the brand name, the advertisement sends a powerful message - that incontinence is a disease easily treated, so (medical/drug) intervention is called for. Once DTC advertising gets a real hold, the danger is that it will become increasingly difficult ever to feel well again. What will happen when such ads become part of the normal diet? How will people come to feel about each other and themselves when the air becomes thick with warnings about possible hidden illness, and easy promises of restoration of health? Always there is the nagging suggestion that people are less and less able to cope themselves - that they can and should turn to drugs and medicine for help. Won't our children and grandchildren find it sickening to be mobbed by thoughts of hidden illness and smothered with images of the ostentatiously well?
To this extent, the ill-effects of DTC advertising are not really to do with the wording of individual examples of ads: increased dependence on medicine(s) would follow, even if advertisers complied scrupulously with strong codes. However, as DTC advertising develops, inevitably brand names will become more prominent, and initial high standard will fall. This would seem a reasonable inference from the findings of a recent analysis of DTC ads in the US, in Consumer Reports. The advertisements were found, in general, of poor quality and of little educational value: "advertisements are not public service messages; they are meant to move goods" (See http://www.medicomint.com/resources/pmt699/pmtreardon699.html )
This may be par for the course with most advertising - but then the industry says that DTC advertising can help address specific, serious and undertreated health problems, including the stigma that promotes resistance to treatment. Depression is an obvious example: the battle against undertreatment is now well joined, and sales grow on and on. Antidepressants are now prescribed more even than benzodiazepine tranquillisers, drugs of dependence like Ativan (lorazepam), Valium (diazepam), and Xanax (alprazolam) - with all that implies. See: The Antidepressant Web at http://www.socialaudit.org.uk/201.htm
DTC advertising has played a significant part in promoting SSRI antidepressants in general and Prozac (fluoxetine) in particular. Last year, Eli Lilly spent $41m on DTC advertising, twice what it had spent the year before. Notably, the company ran a campaign in 20 U.S. Magazines, using a "three-page ad featuring a dark ('Depression hurts') to light ('Prozac can help') motif to explain the facts about depression and the availability of treatment in simple, straightforward terms almost anyone should be able to understand". (MJ Grinfield, "When it comes to depression, there is a lot at stake", Psychiatric Times, 14 (9), September 1997. See:http://mhsource.com/edu/psytimes/p970901.html )
In turn, the introduction of SSRI antidepressants played a big part in promoting the case for advertising directly to the public. SSRIs were launched with such an intense burst of INdirect-To-Consumer promotion, it pretty much blew open the back door. The door gave way because the industry had previously gone to great lengths and considerable expense to orchestrate professional thinking on this matter - making clear the urgent need for treatment with antidepressants, particularly the new, 'improved' SSRIs. In Britain, the industry sponsored the Defeat Depression Campaign, run by the Royal College of Psychiatrists and friends. This led to "consensus" recommendations and guidelines for treatment and did much to promote the idea that depression was widespread and vastly undertreated, yet readily conquered by drug treatment that was safe.
Much the same was achieved in the US, not least through industry funding of a landmark conference held under the auspices of an important national patient alliance, the National Depressive and Manic-Depressive Association (NDMDA). This conference also led to a prominent consensus statement (filling 8 pages of the Journal of the American Medical Association). Its conclusions began as follows:
"There is overwhelming evidence that that individuals with depression are being seriously undertreated. Safe, effective and economical treatments are available. The cost to individuals and society of this undertreatment is substantial. Long-suffering, suicide, occupational impairment, and impairment in interpersonal and family relationships exist " (RMA Hirschfeld, MB Keller, S. Panico et al., Undertreatment of Depression, JAMA 22/29 January 1997, 227(4), 333-340)
The conference had been funded by Bristol-Myers-Squibb, the makers of Serzone/Dutonin (nefazodone). The report emphasised that none of the (overwhelmingly medical) panel members had received an honorarium for attending, but no doubt most of them have relied on industry funding since or before. One who has was the conference co-chair, also the Chair of the Executive Committee of the Scientific Advisory Board of the NDMDA. He is Professor Martin B. Keller, a leading figure in the field, also Vice Chair of the Mood-Disorders Work Group on DSM-IV, and currently Professor of the Psychiatry Department at Brown University. Earlier this month, The Boston Globe reported at length on Professor Keller's close and largely undisclosed relationship with the manufacturers of SSRIs:
"Dr. Martin Keller of Newton earned more than $842,000 last year while serving as chief of the psychiatry department at Brown, according to financial records. More than half of his compensation came from the pharmaceutical industry, including companies such as Pfizer Inc., Bristol-Myers Squibb, Wyeth-Ayerst, and Eli Lilly, all of which market antidepressants that Keller lauded in a series of medical research reports
"In addition, Keller did not disclose the extent of his financial ties with the companies to the medical journals that published his research in 1998, or to the American Psychiatric Association, which sponsored the meetings at which Keller presented his findings . Several ethicists contacted by the Globe say Keller's unusually large consulting fees -- he pulled in a total of $556,000 in 1998 and $444,000 in 1997 -- constitute the most serious potential conflict they've heard of yet ..."
(A Bass, "Drug companies enrich Brown Professor", The Boston Globe, 4 October 1999, Metro section, page A1. For full text [cost $1.50], search on 'Martin Keller' at http://www.boston.com/globe/search/ )
The case against
Opposing the motion at the Kings Fund debate will be Joe Collier, Professor of Medicines Policy at St. George's Hospital Medical School and Editor of the Drug & Therapeutics Bulletin (published by Consumer Association). Well known in the UK as a campaigner for effective use of medicines, Collier is quite independent of commercial ties, but recently he has moved closer to the establishment, as a member of the Medicines Commission and through association with National Institute of Clinical Excellence. Speaking as something of a government expert, also as a representative of the views of consumers and health professionals, Collier can be expected to develop the view he expressed in a recent BBC-TV interview (Newsnight, 4 October 1999) that this whole area is "very, very complicated". So, no battle cries or call to arms.
This is indeed a complex subject because what happens now raises huge questions about public and personal health - and yet the battle already feels lost and very nearly over. In theory, DTC advertising could be kept at bay through resistance from the medical establishment and patient organisations. In practice, there are too many strong vested interests and just too much industry money and covert influence sloshing around. No stopping it when there is no strong and independent leadership, no political mileage in censorship, no political sense in trying to deprive the media of vast advertising revenues, and no realistic prospect of tight enforcement. The existence of the Internet (overwhelmingly US output) means in effect that DTC adverting already exists, that enforcement would not get far.
Still, if you can't stop it, you can at least recognise it for what it is and what it means. And if you don't like the idea, you can then oppose and try to stall it and think about ways of minimising its harmful effects. This seems a worthwhile exercise, for there has been precious little hard and impartial analysis of the deeper impact of DTC advertising - though this is surely a defining moment, a watershed in the development of medicine, community and health?
What does it all mean? The only certain answer is that we've almost left it too late, but have barely begun to understand the consequences. These are some of the questions that belong in the debate there needs to be:
1. To what extent does ill-health result from fear of ill-health, loss of confidence and personal autonomy - and to what extent is it created by suggestion and contagion? Lewis Thomas wrote wisely about the dangers of this long before DTC advertising had begun to make it mark:
"If people are educated to believe they are fundamentally fragile, always on the verge of mortal disease, perpetually in need of health-care professionals at every side, always dependent on an imagined discipline of preventive medicine, there can be no limit to the numbers of doctors offices, clinics, and hospitals required to meet the demand ... We are, in real life, a reasonably healthy people. Far from being ineptly put together, we are amazingly tough, durable organisms, full of health, ready for most contingencies. The new danger to our well-being, if we continue to listen to all the talk, is in becoming a nation of healthy hypochondriacs, living gingerly, worrying ourselves half to death" (L. Thomas, "The Health Care System" in The Medusa and the Snail, New York, Bantam Books, 1980, 39-40)
2. To what extent does a powerfully market-driven system create unsustainable demand and promote division and inequality of access to health? The nub of the fallacy is that "health for me" is barely attainable without "health for all"? My health is intimately to do the health of my community: real madness is to be the only kid on the block not on Prozac or Ritalin. When the flood of marketing translates into whole communities crying more "health for me", there will always be less for you and me - and no healthcare system could possibly meet the demand. It's a paradoxical effect, not unrelated to the notion of a mass market packed with unique beings and rugged individuals.
3. Why should this model of medicine, deemed suitable in the USA, be a good thing for the rest of the world? The question arises because of the high cost of US medicine - with stark lack of evidence of commensurate health gains - and because of the wholesale exclusion from adequate healthcare of a large proportion of the population. To what extent is it appropriate that America's values and priorities dictate trends for the rest of the world?
4. By nature, partial, superficial, repetitive and impersonal - is advertising really a useful source of information, compared with other methods of learning? How much useful and misleading information has it given doctors? Does it not tend to debase and overwhelm good science and promote partial understanding on fundamental issues - e.g. on the relationship between benefit and risk?
5. To what extent will DTC advertising act as a substantial barrier to entry to products of comparable therapeutic value, and lead to higher prices and reduced access to essential drugs? Philip Brown (publisher of the industry newsletter, SCRIP) has a strong handle on this:
"What brought home to me the significance of direct-to-consumer promotion was a comment last week from a senior industry executive who believes that it could become a major factor in shaping the future of the industry. He argued that the success or failure of a new R&D-based prescription product in the US now depends on the size of the direct-to-consumer advertising budget.
"What chance, he asked, does Company A have with, for example, a US$50 million budget for direct-to-consumer advertising for its new prescription medicine, if the far bigger competitor, Company B, decides to spend US$600 million? The short answer is very little " (P. Brown, Will DTC advertising shape the future of the industry? SCRIP Magazine, September 1998, 3)
6. To what extent will DTC advertising corrupt or improve the relationship between doctors and patients, and the quality of treatment and prescribing practice? Philip Brown, again:
"So are we facing a whole new scenario where the market will become dominated by the big direct-to-consumer advertisers - and that means the big companies - and where customer choice, stimulated by advertising, will determine a prescription product's success? Providing the prescribing doctor acquiesces to the demands of the patient, the answer must be yes.
All the evidence suggests that in a free market, what the patient asks for, the doctor will prescribe" Of particular concern is that in many cases the prescription (is) inappropriate, notably where antibiotics were prescribed in viral conditions. But even in these cases, although the prescribing was irrational, the doctors still gave in to patient demand." (Ibid.)
7. What is the dominance of the pharmaceutical industry doing to the leadership of medicine, and to the critical faculties of the press and media? What is happening to the progress and direction of health?
Virtually all of my instincts lead me to think of DTC advertising as a profoundly unhealthy development. I fear its overall effect will be paradoxical: it will promote the very opposite of what health is and was surely meant to be. These are questions to which I expect to return.
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