Winter 2008
Side Effects
Patients and physicians may pay price for direct-to-consumer drug advertising
Classes represented in this story: ’71, ’84, ’85, ’95, ’96
Does this sound familiar? Your favorite television program cuts to a commercial break, and you are soon watching an attractive, middle-aged couple enjoying a hike or lounging on a porch swing. There may or may not be a romp through a meadow of wildflowers, but there will certainly be repetition of a medication’s name and a laundry list of side effects. Sometimes conspicuous by its absence is the condition that the drug treats.
Sandra Kitson, MD ’95, GME ’98, examines a patient at her office in Waco, Texas. |
Advertising prescription drugs to the public can result in situations like one experienced by Sandra Kitson, MD ’95, GME ’98, a family practitioner in Waco, Texas. During a recent office visit, a Hmong husband requested a drug he had seen advertised for his slightly overweight wife so that she would have a “flat tummy.” That particular drug, however, was for treating irritable bowel syndrome.
“The time it takes to re-educate patients who come in with a preconceived need for a drug can be daunting,” Dr. Kitson said.
Direct-to-consumer pharmaceutical advertising is ubiquitous in modern America. According to a study published in the Journal of Health Communication in 2004, American TV viewers watch an average of 30 hours of drug ads per year. In the U.S. Food and Drug Administration’s most recent consumer survey in 2002, 81 percent of respondents reported seeing or hearing an ad for a prescription drug.
The glut of ads has created trends for practicing physicians, some of which can be viewed as positives but many of which are troublesome, according to a number of Medical College of Wisconsin alumni.
“Direct-to-consumer pharmaceutical advertising creates an awareness of selective medical symptoms and disease processes but does not give the patient a balanced presentation,” said John T. Bjork, MD ’71, Fel ’76, a gastroenterologist practicing in Milwaukee. “The patient may inquire about certain symptoms they experience and request brand name medication, but he or she lacks an understanding of a differential diagnosis and alternative therapy. I often need to explain their health issue and that a certain brand name pharmaceutical may not be correct for them.”
Many alumni observe an an educational and awareness function of the advertising, but the value of that knowledge is debatable.
LeeAnne Nazer, MD ’85, is a family medicine doctor practicing in Indianapolis who believes prescription ads have helped medical practice in some ways while hindering it in others. The advertising develops brand recognition, which can make a patient more comfortable with a drug when she suggests it. It has also brought some medical conditions to light in the public eye, as erectile dysfunction (ED), gastroesophageal reflux disease and restless leg syndrome are becoming terms people know. As beneficial as they can be in drawing attention to disease states, they often fall short in many other areas, Dr. Nazer said.
“It doesn’t put into perspective for the patient where this medicine may fall into a treatment regimen, for example, at what stage of disease this may be appropriate, so patients may assume these disease states all need treatment or need these options advertised on TV,” she said. “Another con is that the ads tell the name of the medicine and what it’s used for, then launch directly into side effects, again, not putting all of this into perspective for the patient, that these may be short term, or that they did not cause harm or cause someone to stop taking the drug. I’ve often had people who, after hearing the side effects listed on TV, don’t want to try a medicine.”
Part of the problem may be the manner in which the drugs are presented.
Brian Bear, MD ’84, GME ’89 |
As an obstetrician/gynecologist in the Milwaukee area, Brian Bear, MD ’84, GME ’89, has fielded many questions from his patients about marketed birth control pills, and like most people, has viewed many of the commercials and print ads himself.
“I think it’s good to inform consumers and to make them think about it,” Dr. Bear said. “But the style with which it’s done provides little valuable information, leaving patients guessing what the drug is used for.”
Often, patients come in with an inaccurate understanding of a drug they have seen advertised, Dr. Bear said. A good example is the effect of birth control pills on acne. OB/GYNs know many birth control pills benefit acne, but only two companies have gone through the process to get FDA approval to market their pill for that indication. Patients may come in requesting that brand name pill when a host of others will have the same effect on acne but may be more suitable to the patient for other reasons.
There are times when the symptoms of the condition and purpose of the drug are clear, but other areas need clarification. Jack Watson, MD ’96, a family practitioner in Santa Cruz, Calif., has noticed this with ED drugs.
“With regard to the erectile dysfunction medications, patients understand the problem and how the medicine helps,” he said. “I spend time discussing precautions and side effects, as patients don’t understand these areas well.”
Sifting through the rhetoric
Combating misinformation and miscommunication falls to the office physician, who must provide facts about the appropriateness of a popularized prescription drug. This is increasingly common, as noted in a physician survey that was part of the FDA’s 2004 “Final Report” on direct-to-consumer advertising. In it, 85 percent of surveyed physicians reported that their patients asked about prescription drugs frequently (“often/all the time”).
“I respond to questions concerning an advertised medication by inquiring about their symptoms and concerns regarding a specific medication,” Dr. Bjork said. “The discussion includes medical therapy, drug therapy and alternatives to the advertised medication in regard to advantages, disadvantages and cost. If the advertised medication is appropriate and it is the patient’s preference, I will prescribe it.”
LeeAnne Nazer, MD ’85 |
Dr. Nazer also finds it helpful to outline for the patient how she makes a decision regarding a medication and what steps might be options in the future, even if they are not suitable now.
“I help the patient see if the medicine they asked about would be appropriate or not, based on disease state and the severity of their disease,” she said.
Sometimes, this requires reading between the lines as much as listening to the patient’s reasons for wanting a drug, Dr. Kitson said. Comprehending the insurance aspect of the requested drug can become a necessary part of the conversation as well.
“In the case of onychomycosis, for example, I educate on the long-term resolution of the symptoms and the lack of coverage for this condition with many insurance companies, as it is a cosmetic fix,” Dr. Kitson said. “Even if the requested medication is not necessary for any one particular patient, dialog with our patients on their concerns is always beneficial.”
Costly on many levels
Some experts believe the effect that direct-to-consumer ads has on the doctor-patient relationship and on cost negates any perceived benefit. Eric Cohen, MD, Professor of Medicine (Nephrology) and Nephrology Program Director at the Medical College of Wisconsin, has long been opposed to direct-to-consumer advertising. In 1988, he authored a somewhat prophetic paper published in the New England Journal of Medicine, in which he warns that if direct-to-consumer advertising prevails “the choice of a patient’s medication, even of his or her physician, could then come to depend more on the attractiveness of a full-page spread or prime-time commercial than on medical merit.” Ultimately, he concludes that such advertising serves the ad-makers and media and could actually harm patients, a view he still holds today.
“Patients ask for brand name drugs when in the past, they might not have,” Dr. Cohen said. “That warps the doctor-patient relationship. In addition, the cost of direct-to-consumer ads affects the price of the drugs. The ads cost money, and that money is recouped by the company via higher drug prices. Direct-to-consumer ads also diminish the money available to the drug companies for true research and development.”
Mark N. Zacks, MD ’71, an allergist in Warren, Mich., shares this view, though his own practice has experienced little effect from the advertising boom.
“The ads are very expensive, and the money could be used for research,” he said.
Jack Watson, MD ’96,
with his daughter, Clare. |
Dr. Watson believes these costs also have an overall negative economic impact on the nation. He acknowledges no benefit to the ads.
“The most important con is the added costs to U.S. medical care,” he said. “Direct-to-consumer marketing bears some responsibility for the doubling of U.S. health insurance premiums from 2000 to 2006. As a result, the U.S. now spends close to 16 percent of GDP on health care, which is not economically sustainable, evidenced by the almost 50 million uninsured Americans.”
If it were up to him, Dr. Watson would address the issue with sweeping change.
“I would stop all direct marketing now,” he said. “In short, America can’t afford the advertising. Additionally, for the sake of U.S. children, I don’t think a middle-aged male discussing his erectile dysfunction on TV is appropriate at any hour of the day.”
Prohibited in most of world
The United States is nearly alone in its consent to this type of marketing. The U.S. and New Zealand are the only two countries in the world that permit direct-to-consumer advertising for prescription drugs. Dr. Zacks would like the U.S. to join the vast majority of the world in its treatment of the ads.
“I would ban them completely,” Dr. Zacks said. “They are usually misleading and serve no real benefit to the public.”
This may be easier said than done, as Dr. Cohen points out the ads receive free speech protection from the First Amendment. Consumers also have protection through truth in advertising laws, but as Dr. Kitson observes, this is unlikely to change the volume and frequency of the broadcast and print spots.
“Now that the ads have started, I really don’t see an end in sight for them,” Dr. Kitson said. “Truth in advertising rules should hold for all, and a balanced depiction of just how often any particular drug would be expected to help a particular patient would be ideal. But we all know that patients want the best and newest because that is the American way.”
Dr. Nazer suggests a change in the focus of the ads would benefit everyone. Right now, the focus is on the side effects of a given drug, whereas an emphasis on education and disease states would provide more value to the public, she said.
Bureaucratic complications
John T. Bjork, MD ’71, Fel ’76 |
Like many of his colleagues, Dr. Bjork would prefer that pharmaceutical companies not advertise prescription medication, but he also does not favor federal regulation except in cases where a company is distributing inaccurate or misleading information. Adding bureaucracy to the FDA will only make matters worse. Regardless, physicians hold the final authority.
“Ultimately, the patient obtains the prescription from a physician or his representative and not the pharmaceutical company,” Dr. Bjork said.
The already dense bureaucracy may, in fact, be a contributor to the puzzling manner in which prescription ads are presented to the public, Dr. Bear said. Less bureaucracy may be the key to allowing drug companies to state benefits and indications for their drugs in a way that might be more helpful to patients.
“I do know that these commercials are very confusing, and something should be done to make them more clear-cut and well-intentioned,” said Dr. Bear, who agrees that no matter what messages patients receive, it is up to the physician to clarify and counsel them.
“Each drug needs to be tailored to a patient’s needs, and it’s up to the doctor to evaluate the patient’s health needs and concerns,” Dr. Bear said. “There’s a concern (within the FDA) of influence, but they need to give doctors more credit that we can’t be bought, and we will use the drug that’s best for our patients’ specific health needs.”
FDA holds reins, but spending not curbed
The FDA oversees the advertising of prescription drug products under the Federal Food, Drug and Cosmetic Act and related regulations. It has now been 10 years since the FDA published its guidelines for this industry practice, Consumer-Directed Broadcast Advertisements.
In that time, spending on direct-to-consumer drug advertising increased by nearly 297 percent, according to the U.S. Government Accountability Office. During the same period, spending on promotion to physicians increased by 86 percent and spending on pharmaceutical research and development increased by 103 percent. Spending in the latter two categories is still significantly higher than that on advertising to the public in total dollars, but the trend is unmistakable.