Direct to Consumer Marketing of Prescription Drugs

October 4, 2010

Effect of Pharmaceutical Companies Direct to Consumer Marketing on Doctor/Patient Relationship

Why is the Direct-to-Consumer, DTC in short, advertising of prescription drugs has become an issue in the first place. Shouldn’t it be treated just like any other advertising of consumer goods, like cars and TV-sets, or services, like house improvement or vacation destinations? What makes prescription drugs advertising different from the above mentioned goods and services?

Why has it become such a sensitive point and a battle ground on the basis of ethics between the pharmaceutical companies and their proponents among the general public and the healthcare community alike on the one hand, and vocal, and often fierce, opponents of these DTC advertising techniques, also represented by general public as well as representatives of medical profession.


In order to continue our discussion of the pharmaceutical companies and their use of DTC advertising of prescription drugs we need to acknowledge first that these companies are not inherently designed or intended to be moral agents. The main purpose of the pharmaceutical companies, just like any other for-profit business, is to create profits and to return as much money as possible to the shareholders. Whether we agree with this argument or not is really irrelevant, as this is undoubtedly the reality we are observing in the business world at large and in the practices of the pharmaceutical industry in particular.

On the other hand we also need to acknowledge that the pursuit of profit is not making any business immoral by definition. So, the main issue becomes to identify when and if the interests of a business entity come into contradiction with the interests of the society at large, or its individual constituents.

According to the first step of the Hosmer process we need to identify if there is any harm inflicted to anyone by the pharmaceutical companies’  adoption of the DTC advertising of prescription drugs. To put in practical terms, we should

  • First, identify, if at all possible, the “victims” of these advertising techniques
  • Second, to evaluate what is the measure of damage inflicted on these victims
  • Third, to try to determine if the harm inflicted on the victims  does indeed outweigh the benefits touted by the proponents of the DTC advertising of prescriptions

And this exactly where the evidence available from various sources may point us to significant harm caused by these advertising practices. The harm is no less than the loss of human life and significant damage to health of a considerably large proportion of the users of some prescription drugs.

Based on our research this damage comes mainly from two effects of the DTC advertising of prescription drugs:

  • Marketing of the drugs that have not gone thorough clinical testing and whose harmful side-effects are not properly documented
  • Abuse of the prescribed drugs, mostly painkillers, that are prescribed by unscrupulous or pressured doctors due to patients’ demands

One may argue that these were not the original intentions of the producers and marketers of the killer-drugs.  However, given the enormous potential for these harmful results to happen, a greater measure of precaution should be exercised by the pharmaceutical companies. And that is why we argue that advertising of prescription drugs does not fall under the same level of scrutiny as is acceptable for most other consumer goods or services. Due to this overwhelming potential for harm, we say that pharmaceutical companies should be held accountable to higher standards.

The severe and ultimate consequences of prescription drug advertising described above definitely overshadow other negative effects of these practices. But we still believe that other collateral damage of the DTC advertising should be taken into final account. Below is a short list of those “lesser” negative effects:

People are encouraged to seek drugs they do not actually need.

This situation occurs when the consumers learn about certain health conditions, and due to great emotional effect of the skillfully crafted advertising assume presence of those conditions in their particular situation. This is a so-called “self-diagnosing” effect of direct advertising. This could be illustrated by advertising of a drug for some real medical conditions that occur in a very small proportion of population. But the way it is presented implies that it is a very common disease requiring urgent medical treatment.

“The new and improved” drugs in reality are no better than the old and tested ones, but necessary for the drug companies to offset the loss of profit due to patent expiration and inflow of generic substitutes (read: significantly less expensive) to the market.

These are situations when consumers with diagnosed existing conditions learn about the new drug in the market available for their disease and are lead to believe that this drug has substantial benefits over the old one. An example of this would be heavy advertising of allergy relief drug Clarinex at about the same time when Claritin was getting off the patent protection and becoming an over-the-counter medicine in 2002. The new more potent drug was advertised to have no more drowsing effect than its predecessor Claritin. But in reality, by concession of many medical practitioners, Clarinex is not delivering any significant benefit to most patients. The real difference between them is that one is a prescription drug and the other is over-the-counter at about one third of the price of the former. 

  • Drug companies superficially create new markets for non-existent or blown out of proportion conditions, not even necessarily subject to medical intervention.

One of the examples of this kind of drugs could be anti-depressants for social disorder. In the pre-big pharma days it was considered a personality trait, called introversion, not a medical disease. But now it has become a condition requiring medical treatment thanks to the DTC advertising. And along with that, it is one of the big money-makers for the pharmaceutical companies producing Paxil, Zoloft and the likes.

Increasing cost of health-care due to prescription drugs being prescribed more often than necessary, the phenomenon fueled by significantly higher demand from the patients affected by the DTC. 

Admittedly, this is not the only reason of the health-care costs spiraling out of control. But it is obviously one of the contributing factors. This argument is rather obvious, and in the light of the debate going right now in the nation about harnessing the cost of the health-care, within the framework of the health-care reform, it should be given proper weight.

One more issue which is a bit more subtle and probably harder to pin on the above list of collateral damages, but still raising some ethical concerns, is DTC advertising of so-called “lifestyle” drugs, such as Viagra and Cialis. Many critics of the DTC advertising argue that development and promotion of these drugs unrightfully divert resources necessary for Research and Development of real, life-threatening diseases, such as cancer, diabetes, AIDS and others.    

All of the arguments brought up above are very serious issues raising the need of ethical evaluation of the DTC advertising of the prescription drugs. However there is one more aspect of the problem that is partially touched upon in the previous bullets, but deserves more attention in our opinion, and sometimes overlooked by the researchers of the issue. Namely, what is the effect of the Direct-to-Consumer advertising on doctor-patient relationship.

There are a few different aspects of this issue that we can discuss in the light of ethical analysis.

As was mentioned above, proponents of the DTC advertising often bring up the argument that it is helping to educate consumers about potential conditions and to encourage them to see the doctor for a diagnosis and treatment.

However, Dr. Elizabeth Boyd of the University of California, San Francisco, School of Pharmacy is presenting that statement as more of a question, or ethical dilemma that requires further insight and research. She has put it in a more appropriate way:

Potential Benefits and Harm of DTC Ads:

  • Educate or confuse consumers?
  • Educate or improperly confuse physicians?
  • Improve or worsen health outcomes?
  • Treat underserved patients or create overmedicated society?
  • Improve or worsen provider-patient relationship?

She admits that the existing research data do not provide clear answers on all of those questions. Some of the findings of the existing studies, however, clearly indicate adverse effects of the DTC advertising on doctor-patient relationship which we are going to discuss at more detail here.

In particular, it is interesting to look at the data about patients’ reaction when the request for a drug they have learned about from direct advertising is denied by their doctor:

-          46%  felt disappointed

-          25% try to change physician’s mind

-          24% try to get prescription from a different doctor

-          15% switch doctors

These are somewhat revealing numbers, but they only allow you to peek at the complexity of the impact on doctor-patient relationship caused by DTC advertising of drugs.

The issue in reality is much more complex, to a degree that different studies show significantly different results and interpretations of that impact. 

In the survey conducted in 2003 by Elizabeth Murray et al. and published in The Journal of the American Board of Family Practice about Physicians’ View of [DTC] on Quality of Care and the Doctor-Patient Relationship it was concluded that: “DTCA can have good and bad effects on quality of care, the doctor-patient relationship… The benefits might be maximized, and the harms minimized, by increasing the accuracy of information in advertisements; enhancing physicians’ communication and negotiation skills; and encouraging patients to respect physicians’ clinical expertise”.

In the survey about Public Perceptions of [DTC] Effects on Health Behaviors, Health Care, and the Doctor-Patient Relationship conducted by the same team in 2004 the conclusion was: “DTCA has positive and negative effects on health behaviors.., and the doctor-patient relationship that are greatest on people of low socioeconomic status. The benefits of DTCA in terms of encouraging hard-to-reach sections of the population to seek preventive care must be balanced against increased health care costs caused by clinically inappropriate requests generated by DTCA”.

As one can see from these politically balanced conclusion, the authors of the research try to avoid confrontational language, but even then there is a clear acknowledgement of the ambiguity of the results of DTC advertising of prescription drugs on the doctor-patient relationship.

However, some other doctors are much more clear and decisive in their stance on the issue. For example, the editorial written by Kurt C. Stange, MD, PhD and published in Annals of Family Medicine in 2007  was titled: Time to Ban Direct-to-Consumer Prescription Drug Marketing.  In particular Dr. Stange contended: “DTC ads manipulate the patient’s agenda and steal precious time away from an evidence-based primary care clinician agenda that is attempting to promote healthy behavior, screen for early-stage treatable disease, and address mental health. The negative consequences of this manipulation of the public, the patient, the clinician, and their relationship are subtle but pervasive. … The clinician is put in the role of gatekeeper for the advertised commodity rather than a gateway for prioritizing health care based on the concerns of patients and the science-based recommendations for preventive, chronic disease, mental health, and family care. … DTC ads distort the relationship between patients and clinicians.” Dr. Stange’s article was in part based on the findings of the research conducted by Dominick L. Frosch, PhD et al. aimed at a content analysis of television Direct-to-Consumer advertising.

Regardless of what position a reasonable person is inclined to take after reading these research results, there is no denying that this issues are extremely controversial.

Some of the issues caused by DTC advertising that the physicians regularly face in their interactions with patients are:

-          Physicians need to untangle misconceptions created by DTC advertising. They essentially need to re-educate their patients and to attempt to promote life style changing techniques that are often both no less effective, and less costly than use of the prescription medicine;

-          They also may need to convince their patients to stick to more appropriate, rather than more “glamorous”, medicine, based on doctor’s experience and more in-depth knowledge of the patient and his/her condition;

-          Physicians have to re-establish their authority as primary care givers, which is being subtly usurped by the pharmaceutical companies via their direct access to the consumers;

-          Physicians have to re-claim their prerogative to be their patients’ primary health care advisors instead of being reduced to the role of clerks signing prescriptions based on the demands of their patients induced by the DTC advertising; 

-          They have to maintain the delicate balance between keeping their patients happy and still providing the best possible solution for their condition. The problem with that is that often the best solution is not the one touted by ‘happy-go-lucky’ characters from TV commercials of prescription drugs.

The issues listed above present the challenges that doctors are facing because of the DTC advertising. But there is also the other side of this relationship – the patient. The main question regarding patients is probably: What do patients, and consumers at large, have the right to know about potential medical conditions they might have and available treatments?

We live in the society where information has already become the most precious commodity. The consumers have the right to know about the available drugs. But most importantly, they have the right to receive, as much as possible, truthful, complete, unbiased, and clear information about the drugs, including prescription drugs. Unfortunately, the DTC advertising employed by pharmaceutical companies fails significantly on this account, as evidenced by multiple studies.

The question we are posing here is whether it is possible to find ethical solution to this dilemma.

One of the proposed solutions to the issue of DTC advertising of prescriptions is to create more stringent control mechanisms and enforcement on the direct marketing of pharmaceutical companies, because it has been demonstrated in many studies that the drug manufacturers are often taking the low road of over-emphasizing the benefits of their medicine, while at the same time muting the negative known side-effects of the advertised drugs.

But even if tighter control of the content of DTC advertising was implemented, it still would not solve the issue that some serious, including life-threatening negative side effects are not discovered until later in the life cycle of the drug.

May be it is time to consider complete ban of TV commercials, and print media advertising of prescription drugs aimed at general consumers. The complete and clear information should be made available through internet and other appropriate information channels.

As much as far-fetched this suggestion may seem, let us not forget that in industrialized world the United States is one of only two countries that allow DTC marketing of prescription drugs. And even here it had not been so rampant until the end of nineties when the existing system of checks on DTC drug advertising was removed.

May be it is time for our legislature to review and re-evaluate the existing policies and make another step in protecting consumers’ lives, health, and well-being, as well as making contribution to harnessing the health-care costs.   

References:

         I.            How have pharmaceutical companies marketing practices affected the doctor/patient relationship?

  • Doctors used to prescribe drugs based on an assessment of the patients symptoms
    • Today, patients are asking directly for the name brand prescription
    • How has trust changed between these parties?
    • The internet has changed the availability of drug information to consumers
      • Now consumers feel more well informed than their doctors because of their internet research

 Quotes:

What the survey data can’t tell us is whether this “advertising induced demand” is good or bad from a health perspective – is it mostly encouraging people who might not otherwise get treatment to seek needed medications, or is it mostly leading to demand for unnecessary medications? These questions go beyond what the public can tell us in a survey.

Public Views of Direct-to-Consumer Prescription Drug Advertising, Kaiser Family Foundation Report, May 8, 2009

http://www.kff.org/kaiserpolls/upload/7774.pdf

Medical ethics has traditionally focused on the individual patient, the individual doctor, and the patient-doctor relationship. But today most care occurs in organizational settings – group practices, HMOs, VA and more. Insurers and other third parties have a huge influence on the exam room. Medicare shapes care for the elderly and disabled. Medicaid does the same for the poor. Hospital cultures and policies affect what sick patients experience, for both better and worse.

All this means that the ethical quality of health care is profoundly influenced by the ethics of organizations. We can’t have ethical health care without ethical organizations.

Surveys tell us what the public thinks about right and wrong, not what is right and wrong. But the Kaiser Family Foundation findings have important practical implications.

I believe that if we could study the actual impact of drug advertising we would find it to be largely bad, with relatively little accurate education of consumers about health conditions and treatments, and much unnecessary medication use and cost without benefit. But we won’t be able to do those studies – it’s too hard and too expensive.

In good-versus-good conflicts like this one we could continue arguing until the cows come home without reaching a consensus. Some will make free speech the top value. Others will give preference to the public’s health. But the polls point towards a potential compromise that would respect both key values. With good leadership we could tighten regulation so that truly educative DTC was allowed but duplicitous DTC was not.

Jim Sabin, clinical professor in the departments of Population Medicine and Psychiatry at Harvard Medical School. With colleagues I have written two books about health system ethics: “Setting Limits Fairly: Learning to Share Resources for Health,” and “No Margin, No Mission: Health-Care Organizations and the Quest for Ethical Excellence.”

http://healthcareorganizationalethics.blogspot.com/2008/05/drug-advertising-what-public-thinks.html

The pharmaceutical industry is expected to spend $2 billion this year on advertising, according to the American Medical News, most of it on television. That’s up from $300 million in 1997. Thirty years after we banned cigarette advertising on television, we are being bombarded with an equally insidious message: namely, that for every problem, there is an easy painless solution.

Drug companies are reframing many of the shortcomings in the human condition as problems and providing the solution. Are you shy? That’s not part of your personality. No, we’ve discovered that shyness is really a problem called Social Anxiety Disorder, and it can be treated with the drug Paxil, which is also marketed as an antidepressant. Old solutions such as taking a public speaking class or avoiding stupid parties you don’t want to go to anyway will quickly lose share of mind to Paxil. In this loud, brash culture of ours, shyness just can’t be tolerated, which is too bad because shyness and social anxiety help keep us civilized by promoting modesty and politeness.

But I digress. Hey, I wonder whether there’s a drug for that yet – Digressex or something. Why not?

There’s a new drug to treat PMS called Serafem that, according to its Web site, helps you be “more like the woman you are.” Only Serafem isn’t new – it’s Prozac repackaged in a pink and lavender capsule. It promises to relieve the physical and emotional symptoms of PMS, which in a small minority of women can be quite severe.

The problem is, TV advertising isn’t seen only by that small minority of women who might benefit from Serafem. It’s seen by everyone. And so we can assume once Serafem wins share of mind for irritability and mood swings, millions of women will be asking their doctors about it. And to keep patients happy and in some cases simply to keep patients, many doctors will prescribe it. By bypassing doctors, drug companies can create a demand that is geometrically larger than the need.

That may be good marketing, but it’s not good ethics.

http://www.commondreams.org/views/100700-103.htm

Should prescription drugs be marketed like cars, beer and shampoo? Or are they a special kind of product that demands special treatment in the marketplace?

This information must be accurate to do its job, however; and the federal Food and Drug Administration (FDA) has been reprimanding drug companies for creating ads with misleading and even false information.

FDA regulations are now requiring clear, truthful drug ads that are both useful and understandable. The FDA is reprimanding drug companies on a number of fronts. Ads should not be self-serving nor should they contain misleading information. The FDA is also insisting that ad messages are consistent with product labels.

Overall, the panelists agreed that providing consumers more information is a good thing-as long as the information is accurate and honest. The goal of higher advertising standards is to reduce confusion and increase consumer knowledge.

http://www.tuck.dartmouth.edu/news/releases/pr20040227_ethics.html

A meta-analysis of the literature, “Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift?,” concluded that “interactions with pharmaceutical representatives” are linked to “nonrational prescribing, . . .rapid prescribing of new drugs, and decreased prescribing of generic drugs.” The study appeared in the January 19, 2000, Journal of the American Medical Association.

http://pn.psychiatryonline.org/content/38/18/8.1.full

“When I was in practice, these ads weren’t really in vogue yet,” says Dr. Berczeller, retired professor of medicine at New York University. “But I was worried that they would remove the doctor as a filter, an essential provider of information. Prescribing drugs was intended to be a medical function, not a capitalistic stratagem. It’s wrong for us to be pressured to prescribe by a patient dazzled by a slick ad.”

It’s not only wrong, it’s unnecessarily inflating medical costs. In February the New England Journal of Medicine published a study showing that direct-to-consumer advertising was 16 percent of drug promotion spending. At the same time the National Institute for Health Care Management released a study showing that 2001 drug costs were up 17.1 percent from the year before, with most of the increases in four heavily advertised categories: arthritis, cholesterol, depression and allergy.

Bob Ehrlich, chairman of Rx Insight, a company that advises drug companies on direct-to-consumer advertising, administers a yearly survey course to drug representatives. He admits, “Like it or not, direct-to-consumer advertising has come to symbolize a drug industry hungry for sales and profits at a time when drug access and affordability are key social and political issues.”

The major effect of this full-court press has been to raise drug prices and overall costs as patients pressure doctors to prescribe drugs that often aren’t needed. Doctors find themselves compelled to respond to ad-driven questions rather than those of fundamental medical importance. A report from UCLA last year concluded that doctor/patient roles may be damaged. “We will have a world of aggressive, distrustful and only partially informed patients and cowed physicians,” it says. Surveys by the FDA in 1999 and by Kaiser in 2001 showed that between 20 and 30 percent of consumers, or more than 50 million people, responded to these ads by questioning their doctors. But the same two studies revealed that almost 60 percent of consumers felt that the warnings of potential side effects communicated by these ads were inadequate. It’s no wonder that advertising of prescription drugs directly to the consumer is banned in every country in the world except the United States and New Zealand.

Meanwhile, drug prices skyrocket, transferring the costs of these massive advertising wars over almost identical drugs to the consumer. Last year the AMA protested impotently that the ads did nothing to educate either patients or physicians. Consumer advocacy groups and even HMOs lobby Congress, but the drug-company lobbyists outnumber their opposition eleven to one. The FDA turns a blind eye.

“I saw an ad for an antidepressant during halftime of the Super Bowl,” Ira says. “It showed a beautiful person smiling, saying how much the medicine helped. Soon you’ll have people asking you for the drug who aren’t even depressed.”

http://www.thenation.com/doc/20020617/siegel

The key controversy is not whether DTCA stimulates sales, but whether or not this is good or bad for health, health care quality, and total health care costs.

In a 2002 survey of health professionals in Canada (N = 1975), 67% of GPs reported sometimes or often feeling pressured to prescribe advertised drugs.5 By portraying various medicines as a 100% effective solution to an array of life problems, DTCA turns doctors into gatekeepers for desired brands.

The 2004 market withdrawal of rofecoxib had already raised red flags about DTCA’s ability to rapidly stimulate sales of new drugs with emergent serious risks. Rofecoxib led to an estimated 88 000 to 140 000 heart attacks in the United States, 44% of which were fatal.7 It was among the most heavily advertised drugs for 4 years after the first large-scale clinical trial showed evidence of cardiac risks. In a Kaiser Permanente study, 20% of initial users of cyclooxygenase-2 inhibitors had requested prescriptions after seeing ads.8 These users were 4 times as likely as other users to be inconsistent with treatment guidelines.

Independent consumer groups reject this claim, arguing that DTCA fails to provide the unbiased, comparative information needed for shared and informed treatment choices. Key information, such as the probability of treatment success, is usually missing. Instead, emotive messages dominate: in a sample of television ads, drug use was associated with happiness in 95% of ads, control over one’s life in 85%, and social approval in 78%.9 The US regulatory experience is also instructive—of 135 ads violating US law from 1997 to 2005, 84% minimized risks or exaggerated benefits.

  • Direct-to-consumer prescription drug advertising can cause damage by instigating rapid, widespread stimulation of use of new drugs before harmful effects are fully known.
  • Advertisements exaggerate treatment benefits and use emotive messages to target people with milder health problems, many of whom are unlikely to benefit from the drugs advertised.
  • Advertising leads to higher drug costs and overall health care costs through substitution of new, expensive drugs without treatment advantages

http://www.cfp.ca/cgi/content/full/55/2/131