Conversationally, doctors refer to it as the Zoloft sad egg, the small, weirdly cute animated egg cowering under a rain cloud in its cartoonish struggle to regulate its sadness in one of the most iconic prescription drug ads of the early 2000s.
For pharmaceutical companies, doctors and millions of American prescription patients, it was the face that launched a thousand ads the beginning of a $4.8 billion advertising business that has since expanded to about 80 direct-to-consumer (DTC) prescription ads an hour, according to Nielsen.
To the American Medical Association, the Zoloft egg is one example of a bigger problem they say is having a negative impact on American health care. Calling for a ban of direct-to-consumer drug advertising in November, the AMA accused the ads of driving the demand for often unnecessary, expensive medication.
Direct-to-consumer advertising also inflates demand for new and more expensive drugs, even when these drugs may not be appropriate, AMA board chairwoman-elect Patrice A. Harris said in the AMAs announcement.
But to Pharmaceutical Research and Manufacturers of America (PhRMA), the ads serve a valuable public service in raising awareness about undertreated conditions and new treatment options.
Providing FDA-regulated, scientifically accurate information to patients so that they are better informed about their health care and treatment options is the goal of direct-to-consumer advertising about prescription medicines, PhRMA senior communications director Holly Campbell said in an email. DTC advertising encourages patients to visit their health care providers offices for important conversations about health that might otherwise not take place.
While the call for a ban alone is unlikely to inspire a change to ad guidelines, it could inspire legislation to further restrict what pharmaceutical ads can and cannot include (the Food and Drug Administration declined to comment on ad regulation because of the potential for such legislation). Some doctors dont think that would be a bad thing.
DTC ads are effective in that they increase patient/doctor conversations and prescriptions and, probably, the number of patients in genuine need of prescription therapy to get medications, said Dr. Richard Kravitz, University of California Davis professor of internal medicine. But it also increases the number of unnecessary and harmful prescriptions for patients.
Others question what an ad ban would mean for Americans who could theoretically go their entire lives with a condition thats easily treated because they simply arent aware of treatment options.
Its really difficult to make a statement about all drug ads because you have the coexistence of under-treatment with some conditions, where advertising could help and overtreatment that can hurt, University of Pittsburgh public health researcher Julie Donohue said. Its difficult for regulators to set up rules of the game that will address the lack of awareness without exacerbating the overuse problem.
Changes of heart
A major sticking point for the fight over prescription drug ads is the question of whether or not the ads unnecessarily inflate the costs of the drugs a suspicion many doctors, as well as the AMA, cite as a key reason for reducing DTC marketing.
A 2013 study from pharmaceutical media agency CMI/Compas found that 78 percent of doctors agreed that drug advertising drives up the cost of health care.
Voters are concerned, too consistently ranking drug prices as their top health-care concern in the 2016 presidential election. As The Atlantic reported this spring, the rising cost and demand for prescription drugs in turn impacts insurance costs.
PhRMAs Campbell says theres just as much research to suggest that advertising isnt to blame for rising drug costs, and some say the price of advertising pales in comparison to the bigger burden on the medical system: Undiagnosed, chronic disease.
Whether or not the ad is good or bad depends on whether the new people getting treated are better off with or without the treatment, on balance, University of Chicago economist and drug marketing researcher Brad Shapiro said. If they are truly sick people, then the ad did a good thing by getting them to their physician. If they are hypochondriacs who will pester their physicians into giving them unnecessary treatment, then the ads are a bad thing.
Yet in the past, the pharmaceutical industry has been concerned about the potential overuse cost hikes of prescription drugs due to consumer advertising so much, in fact, that they at one-time opposed consumer advertising publicly.
In a 1984 letter to then-Rep. John Dingell, D-Mich., company heads of some major drug companies wrote that they didnt believe direct-to-consumer advertising was appropriate, safe or in the public health interest.
We reached out to various pharmaceutical companies to get their takes on advertising, including Pfizer and the remaining two companies mentioned in the letter, Eli Lilly & Co. and Schering-Plough.
While all the companies declined to comment about the letter, their collective change of heart is clear. Eli Lilly reversed its position against drug ads in 2002, when CEO Sidney Taurel told Frontline direct-to-consumer advertising had some important health benefits such as raising awareness about under-treated conditions.
Schering-Ploughs public affairs senior vice president Allan Kushen wrote in the letter that the company had serious concerns about direct-to-consumer ads and that they believed it cannot be safely accomplished.
Merck, who bought Schering-Plough in 2009, sees the ads differently, saying in a public policy statement that direct-to-consumer ads can have a positive impact on patient health.
Similarly, the UpJohn Company (now a part of Pfizer since 1995) also objected to direct-to-consumer ads in 1984, saying that there is a vast difference between education and promotion, and speculating that such ads drive up the cost of prescription drugs. Pfizer, like its competitors, maintains the ads benefit public health.
Regardless of any comments made 31 years ago, research shows DTC advertising does not play a direct role in the cost of new medicines, Campbell said in an email response to a question about the reversal of opinion.
Addressing overuse
The reasons pharmaceutical companies changed their stances about consumer advertising are unclear, but the popularity of drugs ads likely has many origins. The FDA, in its ongoing analysis of the impact of drug advertising, cited the influx of retirement-aged baby boomers as one reason for the rise of advertising. Donohue cited the expansion of Medicare and employer-offered insurance plans that cover many prescription drugs as another.
When not faced with the full cost of a prescription, people are more likely to use them, Donohue said.
And they are using them. Prescription drug use is steadily rising, according to the Centers for Disease Control. The number of white Americans on a single prescription increased from 41.1 percent in 1988 to 52.4 in 2012. The number of that group taking five or more prescription drugs grew from 4.2 in 1988 to 10.6 in 2012.
The usage increase makes sense, given that the number of baby boomers approaching retirement (10,000 people a day until 2030, Pew Research Center estimated in 2010) dramatically increases the number of people with conditions common with age, like arthritis or menopause. But Donohue and Shapiro say there's no question advertising increases prescription drug use. Both have published studies that found that DTC ads for antidepressants not only increased use in the drugs advertised, but for competing and generic antidepressants as well.
For some conditions, like depression or diabetes, awareness raised partially through advertising has helped address under-treatment, said Kravitz. But that doesnt mean drug advertising shouldnt change.
Has quality of care improved? Id be hard pressed to say it has, Kravitz said. (Advertising) does engender more dialogue between patients and doctors, but some would say its around a drug, not a condition.
He doesnt think a ban on drug ads would harm public health, but he doesnt think its completely necessary, either, if drug companies would change their ads to better represent the effectiveness of a drug. Hes not alone 74 percent of doctors surveyed in the CMI/Compas survey said they felt the ads overemphasized drug benefits.
Take overactive bladder prescriptions, Kravitz said. As Consumer Reports pointed out in its analysis of overactive bladder drugs, normal urination rates fall somewhere between four to eight times per day, while the 11-16 million U.S. women who qualify as candidates for an overactive bladder prescription make between nine and 12 trips to the bathroom a day despite the caveat that normal urination rates can differ greatly based on any number factors including on a persons fluid intake, activity level and metabolic rate.
But these drugs cut only a couple of bathroom breaks a day in most cases not much of a relief for someone struggling with incontinence.
At that point theyre simply not doing much for the quality of life of patients. In the early years of a drugs life, when side effects and effectiveness are less well-known, I think advertising should be forbidden for the first two or three years of its commercial lifetime, Kravitz said.
Consumer Reports found that more than half the patients who try overactive bladder medications stop after six months, with about half of patients saying side effects outweighed the benefit of the drug.
If the goal is to inform consumers about conditions, the pharmaceutical industry should invest more in collective information dissemination about under-treated conditions rather than drug promotion, Kravitz said. Its all driven by commercial interests.
PhRMAs Campbell says the drug industry adheres to a strict rubric of advertising guidelines to avoid both overuse and wasting patients time including air time dedicated specifically to lengthy lists of possible side effects and the oft-heard disclaimer of drug effectiveness, this drug may not be right for everyone.
Donohue added that drug advertising doesn't effect how safe or effective a drug is, but it does actually help the industry identify what does and doesn't work with a drug. Because while clinical trials are small and establish safety, promoting a drug to a large commercial base gets doctors and drug companies feedback fast on conditions that impact a large population.
"You will dramatically increase number of people you can measure drug risks with when you go to post-marketing use of the drug and the patient population goes from thousands to millions," Donohue said. "From a business standpoint, it makes sense to advertise drugs for conditions where the market can be tens of millions of people."
Until Congress addresses drug ads, Shapiro says medical professionals concerned about the ads impact still have one thing going for them themselves.
Many of the negative effects we might be concerned about would be mitigated by physicians who are willing to rebuff patients who do not need treatment, Shapiro said. After all, it takes a physician to write a prescription, no matter how convinced a consumer is by the ad.
For pharmaceutical companies, doctors and millions of American prescription patients, it was the face that launched a thousand ads the beginning of a $4.8 billion advertising business that has since expanded to about 80 direct-to-consumer (DTC) prescription ads an hour, according to Nielsen.
To the American Medical Association, the Zoloft egg is one example of a bigger problem they say is having a negative impact on American health care. Calling for a ban of direct-to-consumer drug advertising in November, the AMA accused the ads of driving the demand for often unnecessary, expensive medication.
Direct-to-consumer advertising also inflates demand for new and more expensive drugs, even when these drugs may not be appropriate, AMA board chairwoman-elect Patrice A. Harris said in the AMAs announcement.
But to Pharmaceutical Research and Manufacturers of America (PhRMA), the ads serve a valuable public service in raising awareness about undertreated conditions and new treatment options.
Providing FDA-regulated, scientifically accurate information to patients so that they are better informed about their health care and treatment options is the goal of direct-to-consumer advertising about prescription medicines, PhRMA senior communications director Holly Campbell said in an email. DTC advertising encourages patients to visit their health care providers offices for important conversations about health that might otherwise not take place.
While the call for a ban alone is unlikely to inspire a change to ad guidelines, it could inspire legislation to further restrict what pharmaceutical ads can and cannot include (the Food and Drug Administration declined to comment on ad regulation because of the potential for such legislation). Some doctors dont think that would be a bad thing.
DTC ads are effective in that they increase patient/doctor conversations and prescriptions and, probably, the number of patients in genuine need of prescription therapy to get medications, said Dr. Richard Kravitz, University of California Davis professor of internal medicine. But it also increases the number of unnecessary and harmful prescriptions for patients.
Others question what an ad ban would mean for Americans who could theoretically go their entire lives with a condition thats easily treated because they simply arent aware of treatment options.
Its really difficult to make a statement about all drug ads because you have the coexistence of under-treatment with some conditions, where advertising could help and overtreatment that can hurt, University of Pittsburgh public health researcher Julie Donohue said. Its difficult for regulators to set up rules of the game that will address the lack of awareness without exacerbating the overuse problem.
Changes of heart
A major sticking point for the fight over prescription drug ads is the question of whether or not the ads unnecessarily inflate the costs of the drugs a suspicion many doctors, as well as the AMA, cite as a key reason for reducing DTC marketing.
A 2013 study from pharmaceutical media agency CMI/Compas found that 78 percent of doctors agreed that drug advertising drives up the cost of health care.
Voters are concerned, too consistently ranking drug prices as their top health-care concern in the 2016 presidential election. As The Atlantic reported this spring, the rising cost and demand for prescription drugs in turn impacts insurance costs.
PhRMAs Campbell says theres just as much research to suggest that advertising isnt to blame for rising drug costs, and some say the price of advertising pales in comparison to the bigger burden on the medical system: Undiagnosed, chronic disease.
Whether or not the ad is good or bad depends on whether the new people getting treated are better off with or without the treatment, on balance, University of Chicago economist and drug marketing researcher Brad Shapiro said. If they are truly sick people, then the ad did a good thing by getting them to their physician. If they are hypochondriacs who will pester their physicians into giving them unnecessary treatment, then the ads are a bad thing.
Yet in the past, the pharmaceutical industry has been concerned about the potential overuse cost hikes of prescription drugs due to consumer advertising so much, in fact, that they at one-time opposed consumer advertising publicly.
In a 1984 letter to then-Rep. John Dingell, D-Mich., company heads of some major drug companies wrote that they didnt believe direct-to-consumer advertising was appropriate, safe or in the public health interest.
We reached out to various pharmaceutical companies to get their takes on advertising, including Pfizer and the remaining two companies mentioned in the letter, Eli Lilly & Co. and Schering-Plough.
While all the companies declined to comment about the letter, their collective change of heart is clear. Eli Lilly reversed its position against drug ads in 2002, when CEO Sidney Taurel told Frontline direct-to-consumer advertising had some important health benefits such as raising awareness about under-treated conditions.
Schering-Ploughs public affairs senior vice president Allan Kushen wrote in the letter that the company had serious concerns about direct-to-consumer ads and that they believed it cannot be safely accomplished.
Merck, who bought Schering-Plough in 2009, sees the ads differently, saying in a public policy statement that direct-to-consumer ads can have a positive impact on patient health.
Similarly, the UpJohn Company (now a part of Pfizer since 1995) also objected to direct-to-consumer ads in 1984, saying that there is a vast difference between education and promotion, and speculating that such ads drive up the cost of prescription drugs. Pfizer, like its competitors, maintains the ads benefit public health.
Regardless of any comments made 31 years ago, research shows DTC advertising does not play a direct role in the cost of new medicines, Campbell said in an email response to a question about the reversal of opinion.
Addressing overuse
The reasons pharmaceutical companies changed their stances about consumer advertising are unclear, but the popularity of drugs ads likely has many origins. The FDA, in its ongoing analysis of the impact of drug advertising, cited the influx of retirement-aged baby boomers as one reason for the rise of advertising. Donohue cited the expansion of Medicare and employer-offered insurance plans that cover many prescription drugs as another.
When not faced with the full cost of a prescription, people are more likely to use them, Donohue said.
And they are using them. Prescription drug use is steadily rising, according to the Centers for Disease Control. The number of white Americans on a single prescription increased from 41.1 percent in 1988 to 52.4 in 2012. The number of that group taking five or more prescription drugs grew from 4.2 in 1988 to 10.6 in 2012.
The usage increase makes sense, given that the number of baby boomers approaching retirement (10,000 people a day until 2030, Pew Research Center estimated in 2010) dramatically increases the number of people with conditions common with age, like arthritis or menopause. But Donohue and Shapiro say there's no question advertising increases prescription drug use. Both have published studies that found that DTC ads for antidepressants not only increased use in the drugs advertised, but for competing and generic antidepressants as well.
For some conditions, like depression or diabetes, awareness raised partially through advertising has helped address under-treatment, said Kravitz. But that doesnt mean drug advertising shouldnt change.
Has quality of care improved? Id be hard pressed to say it has, Kravitz said. (Advertising) does engender more dialogue between patients and doctors, but some would say its around a drug, not a condition.
He doesnt think a ban on drug ads would harm public health, but he doesnt think its completely necessary, either, if drug companies would change their ads to better represent the effectiveness of a drug. Hes not alone 74 percent of doctors surveyed in the CMI/Compas survey said they felt the ads overemphasized drug benefits.
Take overactive bladder prescriptions, Kravitz said. As Consumer Reports pointed out in its analysis of overactive bladder drugs, normal urination rates fall somewhere between four to eight times per day, while the 11-16 million U.S. women who qualify as candidates for an overactive bladder prescription make between nine and 12 trips to the bathroom a day despite the caveat that normal urination rates can differ greatly based on any number factors including on a persons fluid intake, activity level and metabolic rate.
But these drugs cut only a couple of bathroom breaks a day in most cases not much of a relief for someone struggling with incontinence.
At that point theyre simply not doing much for the quality of life of patients. In the early years of a drugs life, when side effects and effectiveness are less well-known, I think advertising should be forbidden for the first two or three years of its commercial lifetime, Kravitz said.
Consumer Reports found that more than half the patients who try overactive bladder medications stop after six months, with about half of patients saying side effects outweighed the benefit of the drug.
If the goal is to inform consumers about conditions, the pharmaceutical industry should invest more in collective information dissemination about under-treated conditions rather than drug promotion, Kravitz said. Its all driven by commercial interests.
PhRMAs Campbell says the drug industry adheres to a strict rubric of advertising guidelines to avoid both overuse and wasting patients time including air time dedicated specifically to lengthy lists of possible side effects and the oft-heard disclaimer of drug effectiveness, this drug may not be right for everyone.
Donohue added that drug advertising doesn't effect how safe or effective a drug is, but it does actually help the industry identify what does and doesn't work with a drug. Because while clinical trials are small and establish safety, promoting a drug to a large commercial base gets doctors and drug companies feedback fast on conditions that impact a large population.
"You will dramatically increase number of people you can measure drug risks with when you go to post-marketing use of the drug and the patient population goes from thousands to millions," Donohue said. "From a business standpoint, it makes sense to advertise drugs for conditions where the market can be tens of millions of people."
Until Congress addresses drug ads, Shapiro says medical professionals concerned about the ads impact still have one thing going for them themselves.
Many of the negative effects we might be concerned about would be mitigated by physicians who are willing to rebuff patients who do not need treatment, Shapiro said. After all, it takes a physician to write a prescription, no matter how convinced a consumer is by the ad.
