Editorial

Direct-to-consumer promotion of prescription drugs: should product manufacturers just stick to toothpaste, trucks and tampons?

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As recently described by Rosenthal et al (1), spending on prescription drugs has now become the fastest growing component of the health care budget.   While her comments were aimed at the U.S. market, this phenomenon is one of worldwide significance.  

One factor that is probably contributing to this increased spending is direct-to-consumer (DTC) advertising.  As aptly coined by Leacock almost 80 years ago, advertising is “superior to reality” and involves “…the science of arresting human intelligence long enough to get money from it…”. (2)  And what better targets for advertising than health care and prescription drugs, as so many of us have become, to various degrees, "healthy hypochondriacs" (3) who spend inordinate amounts of unproductive time worrying about things that we often cannot change.  As Moynihan et al (4) describe, DTC advertising of prescription drugs is driven in part by the recognition that substantial profits can be made from healthy people who can be made to believe they are sick. 

The spending on DTC advertising in the US alone was reported to be about $2.5 billion in 2000, and this represents a 300% increase over the preceding 4 years.  To put this into context, this represents only 15% of the total funds spent on drug promotion in the United States. (1)  By comparison, the total research and development expenditures reported by all companies in Canada for 2001 was only $1.06 billion CAN (~$0.7 billion US). (5)

So why does industry spend ever increasing amounts of money on DTC advertising of prescription drugs?  Because it works.  Patients who are exposed to DTC advertising request more advertised drugs, and these products are prescribed even when recognized by physicians as not necessarily being the treatment of choice. (6)  DTC advertising is expensive, so manufacturers carefully determine how much money to spend on this form of product promotion on the basis of the number of potential customers, the estimated proportion of these customers that might be persuaded to use their product, the volume of physicians that are likely to prescribe that drug and the monetary return per prescription.  The latter is at least partially based upon intended duration of therapy.  The longer the customer needs to use the product, the greater the return. 

And what drugs do manufacturers typically aim their resources at?  As Mintzes points out, the products of interest are new expensive drugs intended for chronic use by a large population of patients. (7)  In 2000, 20 drugs accounted for about 60% of the total US spending on DTC advertising. (1)  Included in the target list were drugs aimed at weight loss, erectile-dysfunction, birth control, genital herpes and toenail fungal infections.  What an intriguing mix of pharmaceuticals, and an interesting commentary about the ailments of our society.

So what's wrong with advertising a product to the people who are ultimately going to consume it?  After all, isn't that what free enterprise is all about?  Let's list some of the possible pros and cons.

Pros

Cons 

As stated by Mintzes (14), the question is not whether consumers should obtain information about treatment options; the question is whether drug promotion can provide the type of information consumers need.  DTC advertising, in all its direct and indirect forms, is not going to cease…it is just going to become a little more sophisticated, a little more stealthy.  

Where do I personally stand on this issue?  Overall, I'm not in favour of it.  While there may be some benefits related to increased health awareness and enhanced communication with health care professionals that may result from DTC advertising, there are certainly better ways to addresses these important issues without inviting the fox into the henhouse.  Separating drug fact from fiction is something we health care professionals struggle with everyday, and most patients just don’t have the tools to compete with the manufacturers in this regard.  I suspect there is a net negative impact associated with the promotion of prescription drugs directly to the public.  I continue to believe that patients should seek prescription drug information from objective and qualified sources who have no vested interest in the sales of a particular product.  This excludes the manufacturers, and unfortunately, the occasional health care professional.   As I have already stated, advertising costs money.  A lot of money.  Wouldn't it be great if the manufacturers redirected these funds towards reduced drug prices, or even better, drug research and development?  Now that's a novel idea…and what an advertising gimmick that could be in itself.

I would be very interested in your opinions on this subject.  In the interim, consumer beware.  

Peter J. Jewesson, PhD FCSHP
Publishing Co-Editor

J Inform Pharmacother
2002;10:1

References

  1. Rosenthal MB, Berndt ER, Donohue JM, Frank RG, Epstein AM. Promotion of prescription drugs to consumers. N Engl J Med 2002;346:498-505.
  2. Leacock S. The garden of folly. New York: Dodd Mead, 1924:122-31.
  3. Thomas L. The medusa and the snail. New York: Bantam Books. 1980. 
  4. Moynihan R, Heath I, Henry D. Education and debate Selling sickness: the pharmaceutical industry and disease mongering. BMJ 2002;324:886-891.
  5. Patented Medicine Prices Review Board. 2001 Annual Report. Accessed July 09, 2002, at www.pmprb-cepmb.gc.ca/PDF/ar2001/ar2001-e.pdf).
  6. Mintzes B, Barer ML, Kravitz RL, Kazanjian A, Bassett K, Lexchin J, Evans RG, Pan R, Marion SA. Influence of direct to consumer pharmaceutical advertising and patients' requests on prescribing decisions: two site cross sectional survey. BMJ 2002;324:278-9.
  7. Mintzes B. For and against: Direct to consumer advertising is medicalising normal human experience: For. BMJ 2002;324:908-909.
  8. Center for Drug Evaluation and Research. Attitudes and behaviors associated with direct-to-consumer (DTC) promotion of prescription drugs: main survey results. Rockville, Md.: Food and Drug Administration, 1999. (Accessed July 09, 2002, at www.fda.gov/cder/ddmac/dtcindex.htm). 
  9. Mintzes B, Barer ML, Kazanjian A, Bassett K, Evans RB, Morgan S. An Assessment Of The Health System Impacts Of Direct-To-Consumer Advertising Of Prescription Medicines (DTCA): Executive Summary, (Accessed July 09, 2002, at www.cihr-irsc.gc.ca/news/cihr/2002/dtca_e.pdf).
  10. Bonaccorso SN, Sturchio JL. For and against: Direct to consumer advertising is medicalising normal human experience: Against. BMJ 2002; 324: 910-911.
  11. Year two: A National Survey of Consumer Reactions to Direct-to- Consumer Advertising. Prevention Magazine, Emmaus, Pa.: Rodale, 1999. 
  12. Slaughter E. Schumacher M. Prevention’s International Survey on Wellness and Consumer Reactions to DTC Advertising of Rx Drugs. Rodale Press. 2000/2001. 
  13. Wolfe SM. Direct-to-consumer advertising – education or emotion promotion. N Engl J Med 2002;346:524-6. 
  14. Mintzes B. Blurring the boundaries: new trends in drug promotion. Amsterdam: HAI-Europe, 1998. (Accessed July 9, 2002, at www.haiweb.org/pubs/blurring/blurring.intro.html).

Reader Responses to the Editorial, "Direct-to-consumer promotion of prescription drugs: should product manufacturers just stick to toothpaste, trucks and tampons?"

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To the Editors:

I strongly agree with Dr. Jewesson’s conclusion that, all things considered, DTCA has a negative impact on society.  In my opinion, the cons of DTCA far outweigh the pros. As a pharmacist involved in the increasingly difficult, if not impossible, job of containing runaway drug costs at our 400-bed community hospital, I believe the single factor that tips the argument against DTCA is its effect on the growing costs of health care. These swelling health costs are being fueled to a large extent by the escalating expenditures on pharmaceuticals. According to the Canadian Institute for Health Information, $12.3 billion was spent on prescription drugs in Canada in 2001. This was 10.6 % more than the previous year and 50 % more than in 1996. Expenditure on drugs has outstripped inflation and total health spending for more than 15 years. Drugs account for 15.2 cents of every health-care dollar, more than is spent on physicians. What has this increase in expenditures purchased? If the additional costs were associated with a flood of innovative, life-saving drugs, they may be justified. However, a recent analysis by the National Institute for Health Care Management (NIHCM) found that of the 1,035 new drugs approved by FDA in the 12-year period from 1989 to 2000, only 153 (15%) were considered “highly innovative”. Most of the new drugs were categorized as “incrementally modified drugs” or, more accurately, me-too drugs. And it is these new me-too drugs such as Clarinex and Nexium (replacing the off-patent or soon-to-be off-patent drugs Claritin and Losec respectively) that are mainly being promoted via DTCA in the U.S.

Consumers are being baited into paying for these new, expensive drugs when they have not been shown to be any more effective or safer than the older drugs. It is unfortunate that we will probably never see an advertisement for a more cost-effective generic drug or see balanced ads providing objective information on all available therapeutic options for a given disease or condition. But, as damaging as I believe DTCA is, it is just a small component of a powerful and escalating influence by the pharmaceutical industry on the over-all use of and expenditures on drugs. At the risk of being labeled conspiratorial, I believe that the drug industry is an immense cartel, with enormous control over products that are fundamental to public health. It reaps huge profits - 18.5% of 2001 revenues - almost four times that of other Fortune 500 companies and far in excess of the next most profitable industry, Commercial banks (at 13.5% of 2001 revenues) - while being heavily subsidized by taxpayers through research funded by National Institutes of Health (NIH), government-granted patents and huge tax breaks.  What is the extent of this control?

Drug pricing:  Initial prices are too high and arbitrary and are increasing six times faster than general medical inflation. Long patents, legislated by the government, provide virtual monopolies on many drugs so that competition is no longer over price but market niche.  And as if 20 years is not enough, brand-name companies are using elaborate legal procedures to extend patent protection beyond that. Holding up a generic drug by 6 months may cost a drug company several million dollars in legal fees. But that 6 month delay may yield several hundred million dollars in additional sales. The industry’s justification for the high cost of drugs is the huge Research and Development costs required to bring a drug to market.  However, a recent report by Public Citizen has revealed that the often quoted number of US$500,000,000 is misleading. The actual after-tax cost for a new drug (which includes failures) has been calculated at closer to US$100,000,000.  The industry also lobbies our politicians to acquire patent extensions and advantageous policies for regulations and taxation. In the U.S. the drug industry spends $70,000 per year to lobby each US senator and representative, and another $7,000 per individual on campaign donations.

Research:  Drug company-sponsored studies emphasis positive results, while minimizing or suppressing negative outcomes. They exaggerate the benefits of new, high-cost drugs over older, cheaper agents and minimize criticism of the safety or efficacy of their drugs. Cost-benefit analyses are heavily biased in favour of the sponsored drug. The influence of big pharma in medicine is so vast, the editors of the major medical journals such as New England Journal of Medicine and The Lancet have recently agreed to stricter rules on reporting sponsorship and conflicts of interest. A recent study in JAMA on the interactions between authors of clinical practice guidelines and the pharmaceutical industry found serious omissions in declarations of conflicts of interest. Almost 90% of authors received research funding from or acted as consultants for a drug company.  More than half had financial relationships with companies whose drugs were being reviewed in the guideline.

Medical education:  The drug companies provide a substantial proportion of the several billion dollars spent on medical education annually and use that support as a marketing tool. The “education” provided usually consists of skyboxes at hockey games, rounds of golf, dinners, educational vacations at luxury resorts and knickknacks of all description.  Social scientists agree that the prevailing purpose of these gifts is to establish the identity of the donor in the mind of the recipient and to oblige the recipient to reciprocate. The acceptance of even small gifts is known to affect clinical judgement and heighten the perception (as well as the reality) of a conflict of interest. It is no surprise that industry-sponsored education is slanted in favour of the sponsored product and that physicians attending the sessions later prescribe these products more often than competing drugs.

Physician prescribing patterns and consumer demand: The marketing budgets of the large drug companies represent about 40% of revenues, dwarfing their research and development budgets. Canadian drug companies spend a billion dollars a year trying to influence doctors and governments.  In addition to the free pens, dinners, coffee cups and trips, physicians are provided with free drug samples to hook patients on the latest, high-cost, me-too drug - physicians essentially become marketers for the drug company.  The government is also coming under mounting pressure to allow DTCA from so-called “patient advocacy groups” who receive significant funding from drug companies.

The end result of this insidious manipulation by big pharma is increased use of and expenditures on drugs. And that is precisely the goal of the drug industry. But is that what the general public wants or needs? Despite the claim that DTCA is only providing what the consumer wants, recent evidence shows otherwise. The UK Consumer’s Association recently published a survey showing that the general public was deeply suspicious of industry advertising directly to patients. Of the 1818 people surveyed, only a quarter felt that drug companies could be trusted to provide unbiased and comprehensive information about drug therapy. More than half believed that the companies would try to convince people they had a non-existent illness.  The drug companies are setting an agenda that advances their over-riding objective - to sell drugs, maximize profits and increase the value of their shareholders stock.  I am concerned that the goals of health care are in jeopardy of becoming subsidiary to those of the pharmaceutical industry.

Strong action is needed to combat the influence of big pharma. It is the responsibility of the federal government to resist the pressure from the drug industry, and the private broadcasters, and shield the Canadian public from the profit-oriented targeting of consumers. This includes maintaining the current advertising restrictions in Canada. In addition, we (pharmacists, physicians and other health care professionals) have a responsibility to counter the heavy hand of pharmaceutical industry marketing by educating the consumer to reduce demand for the latest drug or technological intervention when there is no additional benefit. We must provide consumers with feedback that forces them to compare value against the cost.

Rob McCollom
Pharmacist
Richmond Hospital
Richmond, British Columbia, Canada

 


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