Running head: Business Ethics Research Paper

Direct to Consumer Marketing of Prescription Drugs

Abstract
Advertising of prescription drugs remains a controversial topic due to the American citizen health and the doctor-patient relationship. There have been many changes in the federal regulation of print and broadcast advertising over the past twenty years. This has been a gray area of regulatory developments since the original Pure Food and Drugs Act of 1906, which limits the informal and indirect marketing of pharmaceutical drugs. Other than the voluntary decision to follow the AMA Code of Ethics, no formal regulation has been enforced.

Direct to Consumer Marketing of Prescription Drugs

My research paper will show both sides in the lively debate of Pharmaceutical companies directly marketing to the American public.
On one side of this debate is the argument that the growth of Direct-to-Consumer advertising has changed the role of a physician in reducing his/her authority. It is also concerning that the non-medically trained average American absorbing the information on benefits and risks from Direct to Consumer advertising instead of trusting the medically trained physician.
The other side of this debate is a lack of public awareness of Pharmaceutical Drug options for medical conditions. Studies have shown mixed results and in 1985, the FDA gave notice in the Federal Register claiming jurisdiction of the Direct to Consumer advertising of prescription drugs so it would provide the American consumer with an adequate safeguard from deceptive or misleading claims.
The Pros and Cons of Direct-to-Consumer advertising According to Mill’s theory of Utilitarianism, The consequence of an action determines the ethical standing of that action. This action is ethical if it provides the greatest amount of good for the greater people. Kantian ethics states the one should act so one’s action could become a universal law. He put emphasis on treating humans as an end to a mean. Advertising does not follow that theory, but they do see humans as a means to increase drug sales.
Pharmaceutical companies advertise drugs on television and in magazines. These ads are being marketed to the general public, not necessarily to people who are being treated for medical conditions. The drug companies view these ads as educational but there are a number of people who believe these companies are trying to convince healthy people they are sick. One way they advertise is to hire well known actors as spokesmen for the drug. This is a subtle way to influence people through the media. Most actors/reporters are not medical experts. They do know what makes a good story and do not intentionally mislead the public but recommend products without the knowledge or disclaimers on side effects and risks. In the 1950’s and 1960’s some companies explored non-advertising marketing through newsreels, event planning and other public areas. “For example, J.B. Roerig & Co, a division of Pfizer, released a newsreel in 1957 to help launch Atarax (hydroxyzine), it’s new minor tranquilizer. The film featured an anxious husband, unable to sleep, who is soothed and educated by his well-informed wife who reads to him about the physiology of tension.” (Greene, Jeremy A., Herzberg, David , 2010). After this short clip the camera zoomed in on the medicine bottle label while the announcer reassured there were new medicines to relieve “mental and physical tension” to a physical state of bliss, known as ataraxia. Companies attracted media attention by adding gimmicks to their medical marketing. This made it more personal to Americans and they felt they could relate and make informed decisions about their own needs over those of the physicians.
For years, Pharmaceutical companies have advertised directly to America’s doctors. They would offer incentives and give billions of dollars of gifts trying to persuade them to prescribe their drug. This was viewed as buying their sales. The drug company would overwhelm the doctor with free samples, pens, clipboards etc and often it was thought the doctor would lose focus on the patient’s best interest. Physicians now that consumers have unreasonable expectations of advertised drugs. They seem to focus on the benefits and none of the side effects. Too make matters worse, ads directed at doctors were also misleading. One study that was reviewed by researchers recommended a drug for a group of people who had not been represented in the study cited. In some cases, a drug that was recommended for everyone with a certain condition and it had only been studied in another group. Consumer Reports magazine reviewed all regulatory letters that the FDA sent from January 1997 through November 2002. The reported results show that direct to consumer ads contained 277 violations. The ads directed at doctors had almost four times as many. Misleading ads can have serious effects on people, the people who take them trusting these companies and doctors. It can also hurt a doctor’s career and even get his license suspended or revoked. Another concern is that prescription drug abuse is on the rise. With the general public learning about different prescription drugs and the treatments and their side effects, there is a huge street market for certain prescription drugs. This is where too much knowledge can be a bad thing. People who take prescription drugs without being diagnosed can be harmed or even killed, just as those who take illegal street drugs. Most people think this is safe because it’s a prescription drug and these companies wouldn’t make it unless it was safe. They don’t view these types of drugs as illegal. Before 1938 there was no such thing as a “prescription drug”. In the seventy years the government has tried to control it we have had more drug-related problems. One of the other abuses that are common and most recently in the news is mothers getting prescriptions for their children’s “ADD/ADHD” and taking the pills themselves. This helps the mom keep up with multiple children/schedules and gives her energy and keeps her on track. The problem with this is this type of medication is extremely addictive. Without the direct-to-consumer marketing would the abundance of these parents know about these drugs? A Kaiser Foundation survey showed “53% see DTC as mostly a good thing. 40% see it as mostly bad. 67% agree with Pharma’s claim that “prescription drug ads educate people about available treatments and encourage them to get help for medical conditions they might not be aware of.” But 66% think DTC encourages people to take drugs they don’t need, and 77% say that DTC makes drugs too expensive.” Sabin, Jim (2008). Free speech is a treasured American value but the first amendment doesn’t restrict advertisers and it doesn’t make sure that they’re telling the truth. Critics have stated that consumers with no clinical or pharmacologic background cannot properly evaluate and understand these advertisements. These advertisements may create a belief among the general public that there is a pill to “fix” every ailment. Studies have shown that increased consumer awareness has led to people visiting their doctors more frequently and they are asking for more tests. IMS Health, a health care information company in Plymouth Meeting, Pa, reported that 1 year after a DTC campaign for alendronate (Fosamax), doctor visits for osteoporosis evaluation nearly doubled. This clearly leads people to be aware of their body, symptoms and realize they are not alone and do not have suffered. Direct to Consumer advertising leads to more prescriptions so the drug companies do have market for this type of advertising. Studies of the full impact of Direct to Consumer advertising have created more questions because of the widespread effects of these promotions. These advertisements create a chain of events that are not limited to one person (consumer) but involve the patient-physician relationship and that affects the spending and physician liability. Consumers are now beginning to ask their doctor for newer costlier medicines when a less expensive drug may be available and work just as well. In one study consumers were asked how they would respond if they asked their doctor for a certain medicine and was turned down. Almost half, 46% said they would try to persuade the doctor to prescribe it. 24% said they would see a different doctor and try to get them to prescribe it. There have been some recent concerns about the cost of these prescriptions and the rising demand. Some think this rise in cost is due to the mass media ads being flooded on television and in print ads. The 25 drugs that contributed most to increase in retail sales of pharmaceuticals in 1999 accounted for 40.7% of the overall $17.7 billion increase in spending. In contrast, the growth for other prescription drugs from 1998 to 1999 was 13.3%. The HIAA attributes rising drug cost to several factors. The first is that the FDA has become more efficient and can approve expensive drug treatments faster. Another is the growth of third-party payments for prescription drugs, this has encouraged the consumer to demand higher cost medication. All of this advertising and requirements set by the FDA and other government organizations may remove the liability of the physician when prescribing some of these medications. In the past the drug companies were protected from adverse effects of their drugs because the doctor was a “learned intermediary” who informed the patients of benefits and side effects. With the new requirements of the drug companies to list all pertinent information in the direct to consumer ads this limits the blame of the doctors. Currently in the information age with this widespread advertising the ability of the doctor to “influence” the consumer/patient had been greatly diminished. The consumer has now assumed the role of the learned intermediary and some courts are now holding the consumer and the drug companies legally responsible. In addition to making drug companies more accountable the court’s ruling also provides a reminder of the growing limitations physicians have in helping patients make informed decisions. Another consideration of pharmaceutical companies advertising drugs directly to consumers and listing conditions on their ads are the sensitivity of the subject matter. Many times these ads appeal to the sensitive or emotional side of the consumer. When you consider the embarrassment, fear, shame and sexual helplessness, vulnerability etc., many of these drugs are advertised in women’s magazines and during sporting shows. This is where the average person under eighteen years old can see and read about sensitive medical conditions. One of the most recognized and controversial ads in recent history was for Viagara. Most of the criticism was focused on ad placement, particularly where young children would see them. It was advertised during prime time television and high school sporting events. Other people claimed that they were advertised a little more than sex toys instead of the medical condition, erectile dysfunction. The ad placement seemed to focus on young men instead of older men who had problems due to recovering from medical treatments like prostate surgery. Some supporters of these ads claim that they are providing information for people who might be reluctant to seek help due to embarrassment.
In conclusion, I see both sides as having valid points. As a child of technology and information I want to be able to look up the facts and weigh the benefits of medicines for myself and my family. There are times when I visit the doctor and I feel rushed and it makes me wonder if he’s considered the information I’ve given and all of the options for treatments of any conditions I might have. This being said, I have no formal medical or pharmaceutical training. Like most people you want to trust your doctor’s judgment but everyone can make mistakes. Information is power in this case. On the other hand, I don’t have medical or pharmaceutical training so my knowledge (information is power) is limited to research and advertising from drug companies. I don’t trust the drug companies will tell me anything that might intentionally deter me from requesting, buying or using their product. This is where I have to trust a doctor or others where I find information off of the internet. Advertising age appropriate information is also a huge concern. There are some things that children shouldn’t be exposed to in certain areas. This is why we have ratings on movies, song lyrics and television. Advertisements should have to adhere to the same rules yet they are not. The only one to complain to is the FCC which is not linked in any way to the FDA. Parents should not have to explain some medical conditions before they feel the child is ready to understand and these ads sometimes force that issue which forces children to “grow up” or have to deal with adult issues. This is a subject that I don’t believe we will ever 100% agree on as a country because we all have different ethical and moral values.

References

"Introduction to Prescription Drugs: Current Controversies." Prescription Drugs. Ed. Sylvia Engdahl. Detroit: Greenhaven Press, 2008. Current Controversies. Opposing Viewpoints in Context. Web. 10 Dec. 2013.
Hartman, L.P., & DesJardins, J.R. (2008). Business ethics: Decision-making for personal integrity & social responsibility. Boston, MA: McGraw Hill.
Huh J, DeLorne DE, Reid LN, An S (2010). “Direct-to-consumer prescription drug advertising: history, regulation, and issues.” Pubmed.gov, March 2010.
Brown, Anne B., Patient Care. 35.6 (Mar. 30, 2001): p22. Retrieved from http://go.galegroup.com/ps/retrieve.do?sgHitCountType=None&sort=RELEVANCE&inPS=true&prodId=AONE&userGroupName=oran95108&tabID=T002&searchId=R3&resultListType=RESULT_LIST&contentSegment=&searchType=AdvancedSearchForm&currentPosition=19&contentSet=GALE%7CA73041023&&docId=GALE|A73041023&docType=GALE&role=
Sabin, J (2008). Health Care Organizational Ethics. Web. 9 May 2008. Retrieved from http://healthcareorganizationalethics.blogspot.com/2008/05/drug-advertising-what-public-thinks.html