Author's Perspective: During a workshop, I asked the audience: "Would you allow a drug pusher to come into your home and convince your children to take drugs?" Of course, everyone in the audience said "No." When I pointed out that they had already allowed it to happen, the audience disagreed vehemently. Then, I showed them this slide:
Most of the audience was surprised, but once they gave it some thought, they realized that I was right. When most of us think of a "drug pusher" we conjure up some street thug in an urban community trying to sell crack cocaine to teenagers and adults. In the meantime, we fail to realize that the most dangerous drugs (prescription, OTC) are being sold to us and our children in broad daylight every day!
In addition to that, we fail to recognize the hidden chemicals being pushed onto us by the fast food industry. Many of the chemicals in the food have drug-like properties that create cravings for more of the same foods, and so we become addicted to these foods. And, in many ways, a food addiction is more difficult to overcome than a traditional drug addiction.
Consequently, we continue to eat these fast foods, which are advertised on television 24/7. Eventually, we get sick, and, then, television tells us to visit our doctor to get a drug for our headache, upset stomach, constipation, high blood pressure, diabetes, or whatever ailment we have.
So, we go running to the doctor to get a prescription; and, 10-15 years later, we find that we're taking several prescription drugs with no end in sight!
Television Statistics
According to the A.C. Nielsen Co., the average American watches more than 4 hours of TV each day (or 28 hours/week, or 2 months of nonstop TV-watching per year). In a 65-year life, that person will have spent 9 years glued to the tube.
FAMILY LIFE
Percentage of households that possess at least one television: 99
Number of TV sets in the average U.S. household: 2.24
Percentage of U.S. homes with three or more TV sets: 66
Number of hours per day that TV is on in an average U.S. home: 6 hours, 47 minutes
Percentage of Americans that regularly watch television while eating dinner: 66
Number of hours of TV watched annually by Americans: 250 billion
Value of that time assuming an average wage of S5/hour: S1.25 trillion
Percentage of Americans who pay for cable TV: 56
Number of videos rented daily in the U.S.: 6 million
Number of public library items checked out daily: 3 million
Percentage of Americans who say they watch too much TV: 49
CHILDREN
Approximate number of studies examining TV's effects on children: 4,000
Number of minutes per week that parents spend in meaningful
conversation with their children: 3.5
Number of minutes per week that the average child watches television: 1,680
Percentage of day care centers that use TV during a typical day: 70
Percentage of parents who would like to limit their children's TV watching: 73
Percentage of 4-6 year-olds who, when asked to choose between watching TV
and spending time with their fathers, preferred television: 54
Hours per year the average American youth spends in school: 900 hours
Hours per year the average American youth watches television: 1500
VIOLENCE
Number of murders seen on TV by the time an average child finishes elementary school: 8,000
Number of violent acts seen on TV by age 18: 200,000
Percentage of Americans who believe TV violence helps precipitate real life mayhem: 79
COMMERCIALISM
Number of 30-second TV commercials seen in a year by an average child: 20,000
Number of TV commercials seen by the average person by age 65: 2 million
Percentage of survey participants (1993) who said that TV commercials
aimed at children make them too materialistic: 92
Rank of food products/fast-food restaurants among TV advertisements to kids: 1
Total spending by 100 leading TV advertisers in 1993: $15 billion
GENERAL
Percentage of local TV news broadcast time devoted to advertising: 30
Percentage devoted to stories about crime, disaster and war: 53.8
Percentage devoted to public service announcements: 0.7
Percentage of Americans who can name The Three Stooges: 59
Percentage who can name at least three justices of the U.S. Supreme Court: 17
Compiled by TV-Free America
1322 18th Street, NW
Washington, DC 20036
Television (via numerous children shows) displays hundreds of commercials telling our children to eat Fruit Loops and other sugar-laden overly-processed cereals; and, tell the parents to take them to McDonald's and other fast food places to eat their fattening, addictive food. Watching television also reduces a child's attention span, creating ADHD children and teens.
Television tells us as adults to also go to McDonald's, Kentucky Fried Chicken, Pizza Hut, Burger King, and other fast food places. Then, when we get sick, television tells us to take an over-the-counter (OTC) drug such as Pepto-Bismo or Alka Seltzer. When that stops working or we have a more serious illness, television tells us to go to our doctor and get a (prescription) drug for your high cholesterol, diabetes, high blood pressure.
With various medical shows that have become or been popular (i.e. ER, Grey's Anatomy), television also teaches us that doctors are good-looking heroes who will save our lives within 60 minutes.
TV Drug Commercials
According to a new study television commercials for prescription drugs are heavily loaded on the emotional side but offer scant information on the disease itself and do little to promote the benefits of a healthy lifestyle.
The study's lead author, Dominick Frosch, an assistant professor of medicine at the University of California, Los Angeles, says TV ads on the whole use emotion instead of information to promote drugs.
In 2005 alone drug companies spent an estimated $1.9 billion on TV advertising, of which a typical TV viewer in the U.S. will watch as much as 16 hours of this direct-to-consumer advertising each year.
In an attempt to establish what strategies were used to sell the drugs, Frosch and his team reviewed a sample of 38 ads for prescription drugs that appeared on network television in June and July 2004.
They found that though 82 percent of the ads made "factual claims," far less provided information about causes and risk factors for illnesses.
However the pharmaceutical industry disagrees condemning the study as flawed because they say it relies on information gathered before new guidelines to improve the commercials took effect.
TV ads for drugs are regulated by the FDA, but following the relaxation of regulations in 1997 there has been an ongoing debate about the effectiveness of TV advertising.
Frosch says the educational value of the ads is modest and relies in the main on an emotional appeal by suggesting people appear happier after taking the drugs.
Frosch and his colleagues recorded pharmaceutical company ads, among them Actonel for bone density problems, Cialis and Levitra for erectile dysfunction, Valtrex for genital herpes, Lipitor for high cholesterol, and Zoloft for depression and social anxiety.
Frosch's team looked at the factual information and how the ads might appeal to viewers, such as rational, emotional, humorous, fantasy appeal, sex appeal, or nostalgia, along with how the ads portrayed the role of the drugs in the lives of the character in the ads and how or if the role of healthy lifestyles was represented.
The team found suggestions about lifestyle changes were most often an afterthought and an adjunct to taking the drug but no commercial mentioned lifestyle change as an alternative to medication.
Frosch also says other medication options, such as cheaper, generic versions of the drug advertised, and lifestyle changes that could help the condition were not mentioned.
According to the study the United States and New Zealand are the only two developed countries which allow drug companies as much unfettered access to the TV airwaves.
Frosch has called on lawmakers to force drug companies to provide more information about the medications they advertise and suggests customers should use skepticism when considering drug manufacturers claims.
Only last year the American Medical Association called for a temporary ban on advertising for newly approved drugs and appealed for more federal oversight but the response from the Pharmaceutical Research and Manufacturers of America was that its voluntary guidelines are "sufficient to deal with the content of direct-to-consumer ads."
The Health Research Group at the watchdog group Public Citizen, says the FDA needs to do more to crack down on prescription drug ads, including levying big fines.
The study is published in the January-February issue of the Annals of Family Medicine.
David Couper went to his doctor after watching a small green creature jump up and down on the nail of an infected toe.
For Anne Nissan, a 17-year-old in Prescott, Ariz., the image that stayed with her was of a party. Women were on a roof in a city, pimple-free and laughing, utterly unbothered by the cramps that immobilized her once a month.
And then there is Samantha Saveri, a transportation planner in Baltimore. She remembers bunnies and the promise of digestive regularity.
Three different people in three different places were all driven to contact their doctors after watching an ad for a prescription medication on television. Each walked into a doctor's office with a specific request, and walked out with a prescription for exactly the medication he or she desired.
The Rise of Prescription Drugs in America
Prescription drug spending is the third most expensive cost in our health care system. And spending seems to grow larger every year. Just last year, the average American got 12 prescriptions a year, as compared with 1992, when Americans got an average of seven prescriptions. In a decade and a half, the use of prescription medication went up 71 percent. This has added about $180 billion to our medical spending.
While there are more medicines on the market today than in 1992, researchers estimate that around 20 percent of the $180 billion increase has absolutely nothing to do with the number of medications available, or increases in the cost of that medication.
To understand this change, one place to look is Wilder, Vt. There, in a tasteful housing complex on the side of a mountain, is the home of Joe Davis.
Davis is retired now, but in his speech and manner it's easy to hear the breezy salesmanship that made him so successful. Davis was an adman: "I was trained — or I was toilet-trained as we like to say — in packaged goods," Davis says. "General Foods, Procter & Gamble — that kind of thing."
Until the 1980s, the kind of people who sold stuff like packaged goods were completely different from the kind of people who sold stuff like prescription drugs. In those days, drugs ads were for doctors, not the public. They were designed by people who worked at these small, technically minded medical advertising companies and targeted this small, technically minded audience.
"Nobody had ever thought that these drugs should be or could be advertised to the patients. It was just outside of people's brains," Davis says. "They thought that only doctors could understand the products. They're technical products. They're scientific products."
But it was more than that. There was a fear — shared by doctors and drug companies alike — that advertising drugs directly to consumers could be harmful. Both the drug companies and the doctors worried that even though consumers couldn't really evaluate whether or not a drug was appropriate, they might become convinced by an ad, and pressure their doctor to prescribe it.
Not only might doctors end up passing out inappropriate medications, but also, drug ads could disrupt the doctor-patient relationship — a relationship that, at the time, was mostly a one-way street. Davis tells this story about his own mother, a sophisticated woman whom he found fumbling with a bottle of pills one day. When he asked what she was taking:
" 'Well,' she said, 'I take a yellow pill, a green pill and a white pill.' I said, 'That's great. What are they for?' "
His mother had no idea what they were for, Davis says. All she knew was that her doctor had told her to take them.
"It was very passive from the patient standpoint," Davis says. "The patient just took whatever orders were given by the doctor."
An Advertising Revolution
It used to work like this: Doctors decided what to prescribe. Drug companies — through medical advertisers — tried to influence doctors. Patients did what they were told.
The only problem, says Davis, was that the system wasn't working out for the drug companies. For them, the system was much too slow.
Because doctors exclusively held the keys to the kingdom, drug companies spent enormous amounts of time and money trying to get their attention. To give you a sense, the average doctor got around 3,000 pieces of mail a year from the drug industry, and to break through this noise often took years.
And so Davis, who had previously only sold packaged goods, approached William Castagnoli, the then-president of a large medical advertising company. The two came up with a solution: They would advertise directly to the patient. They'd get the patient to go in and ask the doctor for the drug. "Pull the drug through the system," Davis says with a certain amount of glee.
There was only one small problem with this solution: It was almost impossible to do.
In the early 1980s, FDA regulations required that drug ads include both the name of a drug and its purpose, as well as information about all the side effects. But side-effect information often took two or three magazine pages of mouse print to catalog, and this wouldn't do for a major television campaign. As Castagnoli says, "We couldn't scroll the whole disclosure information over the television screen — OK?"
But then, in 1986, while designing an ad for a new allergy medication called Seldane, Davis hit on a way around the fine print. He checked with the Food and Drug Administration to see if it would be OK.
"We didn't give the drug's name, Seldane," he says. "All we said was: 'Your doctor now has treatment which won't make you drowsy. See your doctor.' "
This was one of the very first national direct-to-consumer television ad campaigns. The results were nothing short of astounding. Before the ads, Davis says, Seldane made about $34 million in sales a year, which at the time was considered pretty good.
"Our goal was maybe to get this drug up to $100 million in sales. But we went through $100 million," Davis says. "And we said, 'Holy smokes.' And then it went through $300 million. Then $400 million. Then $500 million. $600 [million]! It was unbelievable. We were flabbergasted. And eventually it went to $800 million."
Pharmaceutical companies took note.
Today, drug companies spend $4 billion a year on ads to consumers. In 1997, the FDA rules governing pharmaceutical advertising changed, and now companies can name both the drug and what it's for, while only naming the most significant potential side effects. Then, the number of ads really exploded. The Nielsen Co. estimates that there's an average of 80 drug ads every hour of every day on American television. And those ads clearly produce results:
"Something like a third of consumers who've seen a drug ad have talked to their doctor about it," says Julie Donohue, a professor of public health at the University of Pittsburgh who is considered a leading expert on this subject.
"About two-thirds of those have asked for a prescription. And the majority of people who ask for a prescription have that request honored."
Whether the increase in the number of prescription drugs taken is good or bad for patient health is an open question. There's evidence on both sides. What's not up for debate is this: By taking their case to patients instead of doctors, drug companies increased the amount of money we spend on medicine in America.
The Impact of Direct TV Advertising
A UCLA study suggests that direct to consumer television advertisements of prescription drugs may be influencing Americans to believe they are sicker than they really are and this could lead to taking more medication than they actually need.
The study is published in the current edition of the Annals of Family Medicine.
It was funded by the National Cancer Institute's Centers of Excellence in Cancer Communication Research and the Robert Wood Johnson Foundation, and was led by Assistant Professor of General Internal Medicine and Health Services Research at the David Geffen School of Medicine at the University of California, Los Angeles, Dr Dominick Frosch.
The scientists assessed the educational value of 38 direct to consumer tv ads for prescription drugs and analyzed how they tried to influence viewers. The drugs were for treating illnesses ranging insomnia and depression to high cholesterol and high blood pressure.
Their findings suggest that the ads had virtually no educational value, failed to describe who is most at risk for which illnesses, what their symptoms might be, and whether non-medicinal alternatives such as changes to lifestyle like exercise and diet might also be viable options.
Americans watch up to 16 hours of tv ads about prescription drugs per week. The scientists watched the ads shown during the evening news and prime time periods. They used a coding system that takes into account a number of attributes of each ad. The attributes included the factual claims made about the illness the drug is aimed at, the method used to attract the consumer, and also what is revealed about the behaviour and lifestyle of the people in the ad.
Although they found that over 80 per cent of the advertisements did make some factual claims and put forward rational arguments for use of the drugs, only 25 to 26 per cent of them described symptoms and causes of illnesses, the associated risk factors and how common or rare they are.
The scientists also found that many of the ads portrayed the drugs in terms of people losing (58 per cent) control over their lives and then regaining it (85 per cent) once they took the medication. 78 per cent of the ads also portrayed the medication as engendering social approval, while 58 per cent of them implied that the drug was a medical breakthrough.
The findings also show that nearly all ads (95 per cent) used emotional appeal to influence viewers and none of them showed lifestyle and behaviour change as viable alternatives, except for 19 per cent of them that showed this as an adjunct to taking the drug. 18 per cent of the ads suggested that changes to lifestyle would not be enough to deal with the illness.
The conclusion of the study states that despite the claims that tv ads play an educational role, they contain limited information about causes and symptoms of their target illnesses, their prevalence and risk factors. They also show people that have "lost control over their social, emotional or physical lives without the medication; and they minimize the value of health promotion through lifestyle changes. The ads have limited educational value and may oversell the benefits of drugs in ways that might conflict with promoting population health."
New Zealand and the US are the only developed countries that allow prescription drugs to be advertised direct to the consumer on tv. New Zealand is considering stopping it.
Dr Frosch said that "We're seeing a dramatization of health problems that many people used to manage without prescription drugs," and that the "ads send the message that you need drugs to manage these problems and that without medication your life will be less enjoyable, more painful and maybe even out of control." He said that the US should consider banning direct to consumer tv advertising of prescription drugs too.
Last year, the major pharmaceutical companies pledged that tv ads would portray serious illnesses seriously and would describe warnings, side effects and risks according to new guidelines. And in 2005, Paul Antony, their industry spokesman, told a Senate hearing that "direct to consumer advertising can be a powerful tool in educating millions of people and improving health."
"Creating Demand for Prescription Drugs: A Content Analysis of Television Direct-to-Consumer Advertising."
Dominick L. Frosch, PhD, Patrick M. Krueger, PhD, Robert C. Hornik, PhD, Peter F. Cronholm, MD, MSCE, and Frances K. Barg, PhD.
Annals of Family Medicine 5:6-13 (2007)
TV's Impact on Diabetes and Heart Disease
Americans do love their TV time, watching around five hours of programming a day on average. But this most beloved of passive pastimes may exact a high price, with new research linking TV viewing to a raised risk of diabetes and heart disease.
It's no secret that spending hours in front of the television isn't the healthiest of habits. Studies show that people are more likely to eat high-fat, high-calorie foods while watching the small screen—perhaps swayed in part by ads for soft drinks, chips, and convenience foods. And people who watch a lot of TV also tend to be less active, as more time on the couch can mean less time for exercise.
For these reasons, TV viewing is often blamed as contributing to the rise in obesity in the United States and other developed countries. And it's well established that being overweight or obese can lead to many health problems, including type 2 diabetes and heart disease. But how much of a person's risk of these problems might be traced to their level of TV viewing?
To find out, researchers pooled the results of eight large studies looking at the relationship between TV time and the risk of type 2 diabetes, heart disease or a premature death. The studies followed more than 200,000 people for seven to 10 years, on average, recording their TV habits and tracking their health. None of the participants had been diagnosed with a serious illness at the start of the studies.
Their findings? For every two hours of TV a person watched daily, their risk of developing type 2 diabetes went up by 20 percent, their risk of heart disease climbed by 15 percent, and their risk of dying early (from any cause) rose by 13 percent. The researchers estimated that for every 100,000 people, this would mean 176 new cases of diabetes each year, 38 new cases of fatal heart disease, and 104 premature deaths.
What's interesting about these findings is how closely TV viewing was linked to people's risk—the more they watched, the more likely they were to develop these problems. But we still can't say for certain why dedicated TV viewers had a higher risk. It's likely that their diet and activity level played a role, although most of the studies didn't take a close look at these factors. It's also possible that long stretches of sedentary TV time might have other effects on the body that we don't yet fully understand.
Bottom line. If you watch more than two hours of TV a day, you may have a higher risk of diabetes, heart disease, and an early death. However, we need more research to explore why TV viewing may increase the chance of these problems.
If you are worried about developing diabetes or heart disease, there are lots of things you can do to reduce your risk, including giving up smoking, exercising regularly, and slimming down if you're overweight. Watching less TV might also make a difference, particularly if it helps you adopt a healthier lifestyle in general.
TV Ads for Prescription Drugs Misleading
ScienceDaily (Jan. 3, 2008) — Prescription drug ads on television first hit the airwaves just over a decade ago, but a new University of Georgia study finds that most of them still do not present a fair balance of information, especially when it comes to the risk of side effects.
A team led by Wendy Macias, associate professor in the UGA Grady College of Journalism and Mass Communication, analyzed a week’s worth of direct-to-consumer ads on broadcast and cable television. The found that the average 60-second ad contained less than 8 seconds (13 percent of total ad time) of side effect disclaimers, while the average 30-second ad has less than 4.4 seconds (15 percent of total ad time) of disclaimers. Most of the 15-second ads studied devoted no time at all to disclaimers.
“These ads clearly don’t devote enough time to information about risk,” said Macias, whose results appear in the November/December issue of the journal Health Communication. “Adding to the problem is that the information is often presented in a way that people aren’t likely to comprehend or even pay attention to.”
Macias and her team, which includes Kartik Pashupati at Southern Methodist University and Liza Lewis at The University of Texas at Austin, found that almost all of the ads disclosed side effects solely in a voice-over portion of the ad. Only 2.2 percent of ads had the disclosure in voice-over as well as in text form.
The 1997 FDA guidelines that allowed drug companies to greatly expand the scope of their direct-to-consumer advertising required the companies to “present a fair balance between information about effectiveness and information about risk.”
Fair balance is not defined by the FDA, so Macias created a four-tiered classification: 1.) Lawbreakers are ads that don’t mention side effects at all; 2.) bare minimums are those that list side effects but spend less than 10 percent of time on risk information; 3.) the main pack includes ads that spend more than 10 percent of time on risk information, and 4.) the proactive, safety oriented approach, which gives equal treatment to both the risks and the benefits of the drug.
The researchers found that two percent of the ads studied were clear lawbreakers, 10 percent met bare minimum requirements and 88 percent were in the main pack. The researchers analyzed commercials that aired in 2003, but Macias said current ads are similar in their content and leave much to be desired.
“Very few advertisers are really doing well enough when it comes to actually trying to educate the consumer,” she said. “The ads are presented in such a way that the consumer would have to be paying very close attention and be adept at processing the information to really understand the risks as well as the benefits.”
Proponents of direct-to-consumer ads argue that they help raise awareness of various medical conditions and their treatments. Critics argue that the ads drive up health care costs by steering consumers to costly drugs that they might not need. Still, Nielsen Media Research estimates that pharmaceutical companies spent more than $1.5 billion on direct-to-consumer television ads during the first half of 2007.
Macias said most ads could clearly do more to educate consumers, and points to recent advertisements for Johnson and Johnson’s Ortho Evra® birth control patch that give equal emphasis to the risks and benefits of the drug as an example of a more balanced approach.
“A prescription drug is something that consumers should be making a rational decision about,” Macias said. “And the more information consumers have, the better decisions they can make.”
A History of Drug Ads On TVIt seems like only yesterday when Direct-to-Consumer Advertising (DTCA) of prescription drugs didn’t exist. Now, of course, it can’t be avoided. Let’s take a look at the history of this practice and see if we can explain how this all came about.
Before 1980, there was no such thing as DTCA. The times just weren’t right. But in 1981, a few drug companies made small forays into this unchartered territory. The reaction of the Food and Drug Administration (FDA) was to impose a moratorium on all DTCA so it could research the issue. After a few years, the moratorium was lifted, but essentially it only allowed print advertising in magazines and the like. But it took 14 more years before the FDA issued rules on how to undertake TV advertising.
Why print and not TV? The answer is in the fine print - the fine print in this case being the package insert or the full prescribing information (you know, that little folded up piece of paper that comes in drug boxes and magically opens into something the size of a towel?). More specifically, the fine print refers to the so-called brief summary.
So in the early days, it was in a nutshell: no brief summary no drug ads on TV. But some of you may recall the early days of TV DTCA during which there were a number of very bizarre TV ads that seemed to say nothing. The prototype were the original ads for Rogaine, which said “Did you know that Rogaine was minoxidil?” or “I didn’t know that minoxidil was Rogaine.” Unless you already new what Rogaine was, these ads were quite baffling.
This happened because the FDA Regulations stated that a product could advertise itself on TV if it only presented the brand and generic names (both are required) and more importantly there could be no representation of what the drug was for. The regulations were intended to allow drug companies to detail doctors on their products, and since they would then know what the drugs were for, reminders that just called attention to the name would be worthwhile (for the drug companies).
Now we understand the premise behind those seemingly absurd ads. As reminder ads, they were perfectly legal, but they caused a whole lot of confusion, particularly among regular people who might not have known what those drugs were for. All they could do was to sit and scratch their heads. You still occasionally see these ads such as the ones with people surfing through corn fields saying nothing more than ask your doctor about, let’s say, Allegra (fexofenadine).
We’re coming into the home stretch here, the modern era of DTCA on TV. In 1995, the FDA relented and devised a scheme that they felt everyone could live with. The key phrase in the Regulations that they took advantage of was that ads require a brief summary “unless there are adequate means of disseminating the full prescribing information.”
So FDA crafted a set of rules that would be considered “adequate means.” The ads would have to have four components: a toll-free number for people to call to obtain the PI, a reference to see a magazine where they were concurrently running a print ad (so the person could read the accompanying brief summary), a Web site where the PI could be found and lastly, instructions to ask your doctor or pharmacist for more complete information - got that? Well, the drug companies sure did, and the rest, as they say, is history.
Is TV DTCA here forever? Not necessarily. The FDA has been charged with studying the impacts of DTCA and if they or others were to prove significant negative outcomes, it wouldn’t take FDA very long to say: “Remember that stuff about ‘adequate means?’ well we just decided that the four criteria aren’t enough, and you must now include the entire brief summary.”
Of course, they could just as easily say the same thing without any data, but even the FDA likes to practice safe regulating! And lastly, Congress could always write new laws precluding TV ads for prescription drugs. Stay tuned.
Note: Few things better illustrate the extent that the FDA has come under the control of the drug companies than the DTC changes in 1997. While some of the drug company spokespeople have stated that anyone attacking their misleading television advertisements are attacking free speech, this is a silly argument. It is unlikely that any court would refuse to uphold an action by the FDA that required a complete statement of the risks of these dangerous drugs. It would not prohibit television advertising but allow it, only if the drug companies met the same requirements of pre-August 1997 law.
What can we do? We can contact our U.S. Representative and two U.S. Senators and demand that the rules in effect prior to August of 1997 be required for DTC advertising. It is only if enough of us make our feelings known and demand change that we will see a change.
Top Drug TV Ads
Twenty drugs accounted for 59 percent of all pharmaceutical industry spending on consumer prescription drug ads in 2000. The 20 medicines, followed by their purpose and advertising spending on them in 2000, are:
1. Vioxx, arthritis, $161 million
2. Prilosec, stomach ulcers, $108 million
3. Claritin, antihistamine, $100 million
4. Paxil, antidepressant, $92 million
5. Zocor, high cholesterol, $91 million
6. Viagra, impotence, $90 million
7. Celebrex, arthritis, $79 million
8. Flonase, nasal spray for allergies, $78 million
9. Allegra, antihistamine, $67 million
10. Meridia, weight loss, $65 million
11. Flovent, asthma, $63 million
12. Pravachol, high cholesterol, $62 million
13. Zyrtec, antihistamine, $60 million
14. Singulair, asthma, $59 million
15. Lipitor, high cholesterol, $59 million
16. Nasonex, nasal allergies, $53 million
17. Ortho Tri-Cyclen, oral contraceptive, $47 million
18. Valtrex, genital herpes, $40 million
19. Lamisil, toenail fungus, $39 million
20. Prempro, hormone for osteoporosis, menopause symptoms, $38 million
Top 20 Best-Selling Drugs 2010
In spite of difficult market conditions and patent expiry of several blockbuster drugs, the global pharmaceutical markets expanded to $850 billion in 2010.
In spite of increased generic and new arrival competition, Lipitor retained its top position as the best selling global drug brand in spite of sales decline and competition from generic statins. It was followed by Plavix and Remicade. Plavix became the second drug to have annual sales of over 9 billion dollar. Remicade emerged as the best selling biologics in 2010 and goes ahead of Enbrel by sales.
Roche remains the top company by sales of biologics, anticancer and monoclonal antibodies. As in previous years, companies reported sales differed by over 1-3 billion dollars from the IMS Health reported figures. IMS has over reported sales of Nexium and under reported sales of top biologics during the past few years.
#1 LIPITOR
Treats: High cholesterol
Pfizer $8.4 billion +8%
#2 ZOCOR
Treats: High cholesterol
Merck $4.4 billion (2005 sales) -5%
#3 NEXIUM
Treats: Heartburn
AstraZeneca $4.4 billion +15%
#4 PREVACID
Treats: Heartburn
Abbott & Takeda $3.8 billion -2%
#5 ADVAIR DISKUS
Treats: Asthma
GlaxoSmithKline
$3.6 billion +22%
#6 PLAVIX
Treats: Heart disease
Bristol-Myers Squibb & Sanofi-Aventis
$3.5 billion +15%
#7 ZOLOFT
Treats: Depression
Pfizer $3.1 billion -2%
#8 EPOGEN
Treats: Anemia
Amgen $3.0 billion -1%
#9 PROCRIT
Treats: Anemia
Johnson & Johnson $3.0 billion -9%
#9 PROCRIT
Treats: Anemia
Johnson & Johnson $3.0 billion -9%
#11 ENBREL
Treats: Rheumatoid arthritis
Amgen & Wyeth $2.7 billion +36%
#12 NORVASC
Treats: High blood pressure
Pfizer $2.6 billion +8%
#13 SEROQUEL
Treats: Schizophrenia
AstraZeneca $2.6 billion +25%
#14 EFFEXOR XR
Treats: Depression
Wyeth $2.6 billion -2%
#15 ZYPREXA
Treats: Schizophrenia
Eli Lilly $2.5 billion -16%
#16 SINGULAIR
Treats: Asthma & Allergies
Merck $2.5 billion +14%
#17 PROTONIX
Treats: Heartburn
Wyeth $2.4 billion +0%
#18 RISPERDAL
Treats: Schizophrenia
Johnson & Johnson $2.3 billion +5%
#19 NEULASTA
Treats: Chemotherapy side effects
Amgen $2.2 billion +30%
#20 REMICADE
Treats: Rheumatoid arthritis
Johnson & Johnson $2.2 billion +12%
Fastest-Growing Drugs
#1 VYTORIN
Treats: High cholesterol
Merck & Schering-Plough $917 million +913%
#2 CYMBALTA
Treats: Depression
Eli Lilly $667 million +727%
#3 AVASTIN
Treats: Colorectal cancer
Genentech $948 million +247%
#4 MOBIC
Treats: Arthritis pain
Boerhinger Ingelheim $1.1 billion +116%
#6 HUMIRA
Treats: Rheumatoid arthritis
Abbott Labs $857 million +59%
#7 HERCEPTIN
Treats: Breast cancer
Genentech $750 million +52%
Source: IMS Health, a healthcare information company. Twelve Months
Ending December 2005
Most of the audience was surprised, but once they gave it some thought, they realized that I was right. When most of us think of a "drug pusher" we conjure up some street thug in an urban community trying to sell crack cocaine to teenagers and adults. In the meantime, we fail to realize that the most dangerous drugs (prescription, OTC) are being sold to us and our children in broad daylight every day!
In addition to that, we fail to recognize the hidden chemicals being pushed onto us by the fast food industry. Many of the chemicals in the food have drug-like properties that create cravings for more of the same foods, and so we become addicted to these foods. And, in many ways, a food addiction is more difficult to overcome than a traditional drug addiction.
Consequently, we continue to eat these fast foods, which are advertised on television 24/7. Eventually, we get sick, and, then, television tells us to visit our doctor to get a drug for our headache, upset stomach, constipation, high blood pressure, diabetes, or whatever ailment we have.
So, we go running to the doctor to get a prescription; and, 10-15 years later, we find that we're taking several prescription drugs with no end in sight!
Television Statistics
According to the A.C. Nielsen Co., the average American watches more than 4 hours of TV each day (or 28 hours/week, or 2 months of nonstop TV-watching per year). In a 65-year life, that person will have spent 9 years glued to the tube.
FAMILY LIFE
Percentage of households that possess at least one television: 99
Number of TV sets in the average U.S. household: 2.24
Percentage of U.S. homes with three or more TV sets: 66
Number of hours per day that TV is on in an average U.S. home: 6 hours, 47 minutes
Percentage of Americans that regularly watch television while eating dinner: 66
Number of hours of TV watched annually by Americans: 250 billion
Value of that time assuming an average wage of S5/hour: S1.25 trillion
Percentage of Americans who pay for cable TV: 56
Number of videos rented daily in the U.S.: 6 million
Number of public library items checked out daily: 3 million
Percentage of Americans who say they watch too much TV: 49
CHILDREN
Approximate number of studies examining TV's effects on children: 4,000
Number of minutes per week that parents spend in meaningful
conversation with their children: 3.5
Number of minutes per week that the average child watches television: 1,680
Percentage of day care centers that use TV during a typical day: 70
Percentage of parents who would like to limit their children's TV watching: 73
Percentage of 4-6 year-olds who, when asked to choose between watching TV
and spending time with their fathers, preferred television: 54
Hours per year the average American youth spends in school: 900 hours
Hours per year the average American youth watches television: 1500
VIOLENCE
Number of murders seen on TV by the time an average child finishes elementary school: 8,000
Number of violent acts seen on TV by age 18: 200,000
Percentage of Americans who believe TV violence helps precipitate real life mayhem: 79
COMMERCIALISM
Number of 30-second TV commercials seen in a year by an average child: 20,000
Number of TV commercials seen by the average person by age 65: 2 million
Percentage of survey participants (1993) who said that TV commercials
aimed at children make them too materialistic: 92
Rank of food products/fast-food restaurants among TV advertisements to kids: 1
Total spending by 100 leading TV advertisers in 1993: $15 billion
GENERAL
Percentage of local TV news broadcast time devoted to advertising: 30
Percentage devoted to stories about crime, disaster and war: 53.8
Percentage devoted to public service announcements: 0.7
Percentage of Americans who can name The Three Stooges: 59
Percentage who can name at least three justices of the U.S. Supreme Court: 17
Compiled by TV-Free America
1322 18th Street, NW
Washington, DC 20036
- Influence of Television
- For decades, research and studies have demonstrated that heavy television-viewing may lead to serious health consequences. Now the American medical community, which has long-voiced its concerns about the nation's epidemic of violence, TV addiction and the passive, sedentary nature of TV-watching, is taking a more activist stance, demonstrated by its endorsement of National TV-Turnoff Week.
- The average child will watch 8,000 murders on TV before finishing elementary school. By age eighteen, the average American has seen 200,000 acts of violence on TV, including 40,000 murders. At a meeting in Nashville, TN last July, Dr. John Nelson of the American Medical Association (an endorser of National TV-Turnoff Week) said that if 2,888 out of 3,000 studies show that TV violence is a casual factor in real-life mayhem, "it's a public health problem." The American Psychiatric Association addressed this problem in its endorsement of National TV-Turnoff Week, stating, "We have had a long-standing concern with the impact of television on behavior, especially among children."
- Millions of Americans are so hooked on television that they fit the criteria for substance abuse as defined in the official psychiatric manual, according to Rutgers University psychologist and TV-Free America board member Robert Kubey. Heavy TV viewers exhibit five dependency symptoms--two more than necessary to arrive at a clinical diagnosis of substance abuse. These include: 1) using TV as a sedative; 2) indiscriminate viewing; 3) feeling loss of control while viewing; 4) feeling angry with oneself for watching too much; 5) inability to stop watching; and 6) feeling miserable when kept from watching.
- Violence and addiction are not the only TV-related health problems. A National Health and Nutrition Examination Survey released in October 1995 found 4.7 million children between the ages of 6-17 (11% of this age group) to be severely overweight, more than twice the rate during the 1960's. The main culprits: inactivity (these same children average more than 22 hours of television-viewing a week) and a high-calorie diet. A 1991 study showed that there were an average of 200 junk food ads in four hours of children's Saturday morning cartoons.
- According to William H. Deitz, pediatrician and prominent obesity expert at Tufts University School of Medicine, "The easiest way to reduce inactivity is to turn off the TV set. Almost anything else uses more energy than watching TV."
- Children are not the only Americans suffering from weight problems; one-third of American adults are overweight. According to an American Journal of Public Health study, an adult who watches three hours of TV a day is far more likely to be obese than an adult who watches less than one hour.
- Sometimes the problem is not too much weight; it's too little. Seventy-five percent of American women believe they are too fat, an image problem that often leads to bulimia or anorexia. Sound strange? Not when one takes into account that female models and actresses are twenty-three percent thinner than the average woman and thinner than ninety-five percent of the female population.
Television (via numerous children shows) displays hundreds of commercials telling our children to eat Fruit Loops and other sugar-laden overly-processed cereals; and, tell the parents to take them to McDonald's and other fast food places to eat their fattening, addictive food. Watching television also reduces a child's attention span, creating ADHD children and teens.
Television tells us as adults to also go to McDonald's, Kentucky Fried Chicken, Pizza Hut, Burger King, and other fast food places. Then, when we get sick, television tells us to take an over-the-counter (OTC) drug such as Pepto-Bismo or Alka Seltzer. When that stops working or we have a more serious illness, television tells us to go to our doctor and get a (prescription) drug for your high cholesterol, diabetes, high blood pressure.
With various medical shows that have become or been popular (i.e. ER, Grey's Anatomy), television also teaches us that doctors are good-looking heroes who will save our lives within 60 minutes.
TV Drug Commercials
According to a new study television commercials for prescription drugs are heavily loaded on the emotional side but offer scant information on the disease itself and do little to promote the benefits of a healthy lifestyle.
The study's lead author, Dominick Frosch, an assistant professor of medicine at the University of California, Los Angeles, says TV ads on the whole use emotion instead of information to promote drugs.
In 2005 alone drug companies spent an estimated $1.9 billion on TV advertising, of which a typical TV viewer in the U.S. will watch as much as 16 hours of this direct-to-consumer advertising each year.
In an attempt to establish what strategies were used to sell the drugs, Frosch and his team reviewed a sample of 38 ads for prescription drugs that appeared on network television in June and July 2004.
They found that though 82 percent of the ads made "factual claims," far less provided information about causes and risk factors for illnesses.
However the pharmaceutical industry disagrees condemning the study as flawed because they say it relies on information gathered before new guidelines to improve the commercials took effect.
TV ads for drugs are regulated by the FDA, but following the relaxation of regulations in 1997 there has been an ongoing debate about the effectiveness of TV advertising.
Frosch says the educational value of the ads is modest and relies in the main on an emotional appeal by suggesting people appear happier after taking the drugs.
Frosch and his colleagues recorded pharmaceutical company ads, among them Actonel for bone density problems, Cialis and Levitra for erectile dysfunction, Valtrex for genital herpes, Lipitor for high cholesterol, and Zoloft for depression and social anxiety.
Frosch's team looked at the factual information and how the ads might appeal to viewers, such as rational, emotional, humorous, fantasy appeal, sex appeal, or nostalgia, along with how the ads portrayed the role of the drugs in the lives of the character in the ads and how or if the role of healthy lifestyles was represented.
The team found suggestions about lifestyle changes were most often an afterthought and an adjunct to taking the drug but no commercial mentioned lifestyle change as an alternative to medication.
Frosch also says other medication options, such as cheaper, generic versions of the drug advertised, and lifestyle changes that could help the condition were not mentioned.
According to the study the United States and New Zealand are the only two developed countries which allow drug companies as much unfettered access to the TV airwaves.
Frosch has called on lawmakers to force drug companies to provide more information about the medications they advertise and suggests customers should use skepticism when considering drug manufacturers claims.
Only last year the American Medical Association called for a temporary ban on advertising for newly approved drugs and appealed for more federal oversight but the response from the Pharmaceutical Research and Manufacturers of America was that its voluntary guidelines are "sufficient to deal with the content of direct-to-consumer ads."
The Health Research Group at the watchdog group Public Citizen, says the FDA needs to do more to crack down on prescription drug ads, including levying big fines.
The study is published in the January-February issue of the Annals of Family Medicine.
TV: The Hidden Drug Pusher
Selling Sickness: How Drug Ads Changed Health CareDavid Couper went to his doctor after watching a small green creature jump up and down on the nail of an infected toe.
For Anne Nissan, a 17-year-old in Prescott, Ariz., the image that stayed with her was of a party. Women were on a roof in a city, pimple-free and laughing, utterly unbothered by the cramps that immobilized her once a month.
And then there is Samantha Saveri, a transportation planner in Baltimore. She remembers bunnies and the promise of digestive regularity.
Three different people in three different places were all driven to contact their doctors after watching an ad for a prescription medication on television. Each walked into a doctor's office with a specific request, and walked out with a prescription for exactly the medication he or she desired.
The Rise of Prescription Drugs in America
Prescription drug spending is the third most expensive cost in our health care system. And spending seems to grow larger every year. Just last year, the average American got 12 prescriptions a year, as compared with 1992, when Americans got an average of seven prescriptions. In a decade and a half, the use of prescription medication went up 71 percent. This has added about $180 billion to our medical spending.
While there are more medicines on the market today than in 1992, researchers estimate that around 20 percent of the $180 billion increase has absolutely nothing to do with the number of medications available, or increases in the cost of that medication.
To understand this change, one place to look is Wilder, Vt. There, in a tasteful housing complex on the side of a mountain, is the home of Joe Davis.
Davis is retired now, but in his speech and manner it's easy to hear the breezy salesmanship that made him so successful. Davis was an adman: "I was trained — or I was toilet-trained as we like to say — in packaged goods," Davis says. "General Foods, Procter & Gamble — that kind of thing."
Until the 1980s, the kind of people who sold stuff like packaged goods were completely different from the kind of people who sold stuff like prescription drugs. In those days, drugs ads were for doctors, not the public. They were designed by people who worked at these small, technically minded medical advertising companies and targeted this small, technically minded audience.
"Nobody had ever thought that these drugs should be or could be advertised to the patients. It was just outside of people's brains," Davis says. "They thought that only doctors could understand the products. They're technical products. They're scientific products."
But it was more than that. There was a fear — shared by doctors and drug companies alike — that advertising drugs directly to consumers could be harmful. Both the drug companies and the doctors worried that even though consumers couldn't really evaluate whether or not a drug was appropriate, they might become convinced by an ad, and pressure their doctor to prescribe it.
Not only might doctors end up passing out inappropriate medications, but also, drug ads could disrupt the doctor-patient relationship — a relationship that, at the time, was mostly a one-way street. Davis tells this story about his own mother, a sophisticated woman whom he found fumbling with a bottle of pills one day. When he asked what she was taking:
" 'Well,' she said, 'I take a yellow pill, a green pill and a white pill.' I said, 'That's great. What are they for?' "
His mother had no idea what they were for, Davis says. All she knew was that her doctor had told her to take them.
"It was very passive from the patient standpoint," Davis says. "The patient just took whatever orders were given by the doctor."
An Advertising Revolution
It used to work like this: Doctors decided what to prescribe. Drug companies — through medical advertisers — tried to influence doctors. Patients did what they were told.
The only problem, says Davis, was that the system wasn't working out for the drug companies. For them, the system was much too slow.
Because doctors exclusively held the keys to the kingdom, drug companies spent enormous amounts of time and money trying to get their attention. To give you a sense, the average doctor got around 3,000 pieces of mail a year from the drug industry, and to break through this noise often took years.
And so Davis, who had previously only sold packaged goods, approached William Castagnoli, the then-president of a large medical advertising company. The two came up with a solution: They would advertise directly to the patient. They'd get the patient to go in and ask the doctor for the drug. "Pull the drug through the system," Davis says with a certain amount of glee.
There was only one small problem with this solution: It was almost impossible to do.
In the early 1980s, FDA regulations required that drug ads include both the name of a drug and its purpose, as well as information about all the side effects. But side-effect information often took two or three magazine pages of mouse print to catalog, and this wouldn't do for a major television campaign. As Castagnoli says, "We couldn't scroll the whole disclosure information over the television screen — OK?"
But then, in 1986, while designing an ad for a new allergy medication called Seldane, Davis hit on a way around the fine print. He checked with the Food and Drug Administration to see if it would be OK.
"We didn't give the drug's name, Seldane," he says. "All we said was: 'Your doctor now has treatment which won't make you drowsy. See your doctor.' "
This was one of the very first national direct-to-consumer television ad campaigns. The results were nothing short of astounding. Before the ads, Davis says, Seldane made about $34 million in sales a year, which at the time was considered pretty good.
"Our goal was maybe to get this drug up to $100 million in sales. But we went through $100 million," Davis says. "And we said, 'Holy smokes.' And then it went through $300 million. Then $400 million. Then $500 million. $600 [million]! It was unbelievable. We were flabbergasted. And eventually it went to $800 million."
Pharmaceutical companies took note.
Today, drug companies spend $4 billion a year on ads to consumers. In 1997, the FDA rules governing pharmaceutical advertising changed, and now companies can name both the drug and what it's for, while only naming the most significant potential side effects. Then, the number of ads really exploded. The Nielsen Co. estimates that there's an average of 80 drug ads every hour of every day on American television. And those ads clearly produce results:
"Something like a third of consumers who've seen a drug ad have talked to their doctor about it," says Julie Donohue, a professor of public health at the University of Pittsburgh who is considered a leading expert on this subject.
"About two-thirds of those have asked for a prescription. And the majority of people who ask for a prescription have that request honored."
Whether the increase in the number of prescription drugs taken is good or bad for patient health is an open question. There's evidence on both sides. What's not up for debate is this: By taking their case to patients instead of doctors, drug companies increased the amount of money we spend on medicine in America.
The Impact of Direct TV Advertising
A UCLA study suggests that direct to consumer television advertisements of prescription drugs may be influencing Americans to believe they are sicker than they really are and this could lead to taking more medication than they actually need.
The study is published in the current edition of the Annals of Family Medicine.
It was funded by the National Cancer Institute's Centers of Excellence in Cancer Communication Research and the Robert Wood Johnson Foundation, and was led by Assistant Professor of General Internal Medicine and Health Services Research at the David Geffen School of Medicine at the University of California, Los Angeles, Dr Dominick Frosch.
The scientists assessed the educational value of 38 direct to consumer tv ads for prescription drugs and analyzed how they tried to influence viewers. The drugs were for treating illnesses ranging insomnia and depression to high cholesterol and high blood pressure.
Their findings suggest that the ads had virtually no educational value, failed to describe who is most at risk for which illnesses, what their symptoms might be, and whether non-medicinal alternatives such as changes to lifestyle like exercise and diet might also be viable options.
Americans watch up to 16 hours of tv ads about prescription drugs per week. The scientists watched the ads shown during the evening news and prime time periods. They used a coding system that takes into account a number of attributes of each ad. The attributes included the factual claims made about the illness the drug is aimed at, the method used to attract the consumer, and also what is revealed about the behaviour and lifestyle of the people in the ad.
Although they found that over 80 per cent of the advertisements did make some factual claims and put forward rational arguments for use of the drugs, only 25 to 26 per cent of them described symptoms and causes of illnesses, the associated risk factors and how common or rare they are.
The scientists also found that many of the ads portrayed the drugs in terms of people losing (58 per cent) control over their lives and then regaining it (85 per cent) once they took the medication. 78 per cent of the ads also portrayed the medication as engendering social approval, while 58 per cent of them implied that the drug was a medical breakthrough.
The findings also show that nearly all ads (95 per cent) used emotional appeal to influence viewers and none of them showed lifestyle and behaviour change as viable alternatives, except for 19 per cent of them that showed this as an adjunct to taking the drug. 18 per cent of the ads suggested that changes to lifestyle would not be enough to deal with the illness.
The conclusion of the study states that despite the claims that tv ads play an educational role, they contain limited information about causes and symptoms of their target illnesses, their prevalence and risk factors. They also show people that have "lost control over their social, emotional or physical lives without the medication; and they minimize the value of health promotion through lifestyle changes. The ads have limited educational value and may oversell the benefits of drugs in ways that might conflict with promoting population health."
New Zealand and the US are the only developed countries that allow prescription drugs to be advertised direct to the consumer on tv. New Zealand is considering stopping it.
Dr Frosch said that "We're seeing a dramatization of health problems that many people used to manage without prescription drugs," and that the "ads send the message that you need drugs to manage these problems and that without medication your life will be less enjoyable, more painful and maybe even out of control." He said that the US should consider banning direct to consumer tv advertising of prescription drugs too.
Last year, the major pharmaceutical companies pledged that tv ads would portray serious illnesses seriously and would describe warnings, side effects and risks according to new guidelines. And in 2005, Paul Antony, their industry spokesman, told a Senate hearing that "direct to consumer advertising can be a powerful tool in educating millions of people and improving health."
"Creating Demand for Prescription Drugs: A Content Analysis of Television Direct-to-Consumer Advertising."
Dominick L. Frosch, PhD, Patrick M. Krueger, PhD, Robert C. Hornik, PhD, Peter F. Cronholm, MD, MSCE, and Frances K. Barg, PhD.
Annals of Family Medicine 5:6-13 (2007)
TV's Impact on Diabetes and Heart Disease
Americans do love their TV time, watching around five hours of programming a day on average. But this most beloved of passive pastimes may exact a high price, with new research linking TV viewing to a raised risk of diabetes and heart disease.
It's no secret that spending hours in front of the television isn't the healthiest of habits. Studies show that people are more likely to eat high-fat, high-calorie foods while watching the small screen—perhaps swayed in part by ads for soft drinks, chips, and convenience foods. And people who watch a lot of TV also tend to be less active, as more time on the couch can mean less time for exercise.
For these reasons, TV viewing is often blamed as contributing to the rise in obesity in the United States and other developed countries. And it's well established that being overweight or obese can lead to many health problems, including type 2 diabetes and heart disease. But how much of a person's risk of these problems might be traced to their level of TV viewing?
To find out, researchers pooled the results of eight large studies looking at the relationship between TV time and the risk of type 2 diabetes, heart disease or a premature death. The studies followed more than 200,000 people for seven to 10 years, on average, recording their TV habits and tracking their health. None of the participants had been diagnosed with a serious illness at the start of the studies.
Their findings? For every two hours of TV a person watched daily, their risk of developing type 2 diabetes went up by 20 percent, their risk of heart disease climbed by 15 percent, and their risk of dying early (from any cause) rose by 13 percent. The researchers estimated that for every 100,000 people, this would mean 176 new cases of diabetes each year, 38 new cases of fatal heart disease, and 104 premature deaths.
What's interesting about these findings is how closely TV viewing was linked to people's risk—the more they watched, the more likely they were to develop these problems. But we still can't say for certain why dedicated TV viewers had a higher risk. It's likely that their diet and activity level played a role, although most of the studies didn't take a close look at these factors. It's also possible that long stretches of sedentary TV time might have other effects on the body that we don't yet fully understand.
Bottom line. If you watch more than two hours of TV a day, you may have a higher risk of diabetes, heart disease, and an early death. However, we need more research to explore why TV viewing may increase the chance of these problems.
If you are worried about developing diabetes or heart disease, there are lots of things you can do to reduce your risk, including giving up smoking, exercising regularly, and slimming down if you're overweight. Watching less TV might also make a difference, particularly if it helps you adopt a healthier lifestyle in general.
TV Ads for Prescription Drugs Misleading
ScienceDaily (Jan. 3, 2008) — Prescription drug ads on television first hit the airwaves just over a decade ago, but a new University of Georgia study finds that most of them still do not present a fair balance of information, especially when it comes to the risk of side effects.
A team led by Wendy Macias, associate professor in the UGA Grady College of Journalism and Mass Communication, analyzed a week’s worth of direct-to-consumer ads on broadcast and cable television. The found that the average 60-second ad contained less than 8 seconds (13 percent of total ad time) of side effect disclaimers, while the average 30-second ad has less than 4.4 seconds (15 percent of total ad time) of disclaimers. Most of the 15-second ads studied devoted no time at all to disclaimers.
“These ads clearly don’t devote enough time to information about risk,” said Macias, whose results appear in the November/December issue of the journal Health Communication. “Adding to the problem is that the information is often presented in a way that people aren’t likely to comprehend or even pay attention to.”
Macias and her team, which includes Kartik Pashupati at Southern Methodist University and Liza Lewis at The University of Texas at Austin, found that almost all of the ads disclosed side effects solely in a voice-over portion of the ad. Only 2.2 percent of ads had the disclosure in voice-over as well as in text form.
The 1997 FDA guidelines that allowed drug companies to greatly expand the scope of their direct-to-consumer advertising required the companies to “present a fair balance between information about effectiveness and information about risk.”
Fair balance is not defined by the FDA, so Macias created a four-tiered classification: 1.) Lawbreakers are ads that don’t mention side effects at all; 2.) bare minimums are those that list side effects but spend less than 10 percent of time on risk information; 3.) the main pack includes ads that spend more than 10 percent of time on risk information, and 4.) the proactive, safety oriented approach, which gives equal treatment to both the risks and the benefits of the drug.
The researchers found that two percent of the ads studied were clear lawbreakers, 10 percent met bare minimum requirements and 88 percent were in the main pack. The researchers analyzed commercials that aired in 2003, but Macias said current ads are similar in their content and leave much to be desired.
“Very few advertisers are really doing well enough when it comes to actually trying to educate the consumer,” she said. “The ads are presented in such a way that the consumer would have to be paying very close attention and be adept at processing the information to really understand the risks as well as the benefits.”
Proponents of direct-to-consumer ads argue that they help raise awareness of various medical conditions and their treatments. Critics argue that the ads drive up health care costs by steering consumers to costly drugs that they might not need. Still, Nielsen Media Research estimates that pharmaceutical companies spent more than $1.5 billion on direct-to-consumer television ads during the first half of 2007.
Macias said most ads could clearly do more to educate consumers, and points to recent advertisements for Johnson and Johnson’s Ortho Evra® birth control patch that give equal emphasis to the risks and benefits of the drug as an example of a more balanced approach.
“A prescription drug is something that consumers should be making a rational decision about,” Macias said. “And the more information consumers have, the better decisions they can make.”
A History of Drug Ads On TVIt seems like only yesterday when Direct-to-Consumer Advertising (DTCA) of prescription drugs didn’t exist. Now, of course, it can’t be avoided. Let’s take a look at the history of this practice and see if we can explain how this all came about.
Before 1980, there was no such thing as DTCA. The times just weren’t right. But in 1981, a few drug companies made small forays into this unchartered territory. The reaction of the Food and Drug Administration (FDA) was to impose a moratorium on all DTCA so it could research the issue. After a few years, the moratorium was lifted, but essentially it only allowed print advertising in magazines and the like. But it took 14 more years before the FDA issued rules on how to undertake TV advertising.
Why print and not TV? The answer is in the fine print - the fine print in this case being the package insert or the full prescribing information (you know, that little folded up piece of paper that comes in drug boxes and magically opens into something the size of a towel?). More specifically, the fine print refers to the so-called brief summary.
So in the early days, it was in a nutshell: no brief summary no drug ads on TV. But some of you may recall the early days of TV DTCA during which there were a number of very bizarre TV ads that seemed to say nothing. The prototype were the original ads for Rogaine, which said “Did you know that Rogaine was minoxidil?” or “I didn’t know that minoxidil was Rogaine.” Unless you already new what Rogaine was, these ads were quite baffling.
This happened because the FDA Regulations stated that a product could advertise itself on TV if it only presented the brand and generic names (both are required) and more importantly there could be no representation of what the drug was for. The regulations were intended to allow drug companies to detail doctors on their products, and since they would then know what the drugs were for, reminders that just called attention to the name would be worthwhile (for the drug companies).
Now we understand the premise behind those seemingly absurd ads. As reminder ads, they were perfectly legal, but they caused a whole lot of confusion, particularly among regular people who might not have known what those drugs were for. All they could do was to sit and scratch their heads. You still occasionally see these ads such as the ones with people surfing through corn fields saying nothing more than ask your doctor about, let’s say, Allegra (fexofenadine).
We’re coming into the home stretch here, the modern era of DTCA on TV. In 1995, the FDA relented and devised a scheme that they felt everyone could live with. The key phrase in the Regulations that they took advantage of was that ads require a brief summary “unless there are adequate means of disseminating the full prescribing information.”
So FDA crafted a set of rules that would be considered “adequate means.” The ads would have to have four components: a toll-free number for people to call to obtain the PI, a reference to see a magazine where they were concurrently running a print ad (so the person could read the accompanying brief summary), a Web site where the PI could be found and lastly, instructions to ask your doctor or pharmacist for more complete information - got that? Well, the drug companies sure did, and the rest, as they say, is history.
Is TV DTCA here forever? Not necessarily. The FDA has been charged with studying the impacts of DTCA and if they or others were to prove significant negative outcomes, it wouldn’t take FDA very long to say: “Remember that stuff about ‘adequate means?’ well we just decided that the four criteria aren’t enough, and you must now include the entire brief summary.”
Of course, they could just as easily say the same thing without any data, but even the FDA likes to practice safe regulating! And lastly, Congress could always write new laws precluding TV ads for prescription drugs. Stay tuned.
Note: Few things better illustrate the extent that the FDA has come under the control of the drug companies than the DTC changes in 1997. While some of the drug company spokespeople have stated that anyone attacking their misleading television advertisements are attacking free speech, this is a silly argument. It is unlikely that any court would refuse to uphold an action by the FDA that required a complete statement of the risks of these dangerous drugs. It would not prohibit television advertising but allow it, only if the drug companies met the same requirements of pre-August 1997 law.
What can we do? We can contact our U.S. Representative and two U.S. Senators and demand that the rules in effect prior to August of 1997 be required for DTC advertising. It is only if enough of us make our feelings known and demand change that we will see a change.
Top Drug TV Ads
Twenty drugs accounted for 59 percent of all pharmaceutical industry spending on consumer prescription drug ads in 2000. The 20 medicines, followed by their purpose and advertising spending on them in 2000, are:
1. Vioxx, arthritis, $161 million
2. Prilosec, stomach ulcers, $108 million
3. Claritin, antihistamine, $100 million
4. Paxil, antidepressant, $92 million
5. Zocor, high cholesterol, $91 million
6. Viagra, impotence, $90 million
7. Celebrex, arthritis, $79 million
8. Flonase, nasal spray for allergies, $78 million
9. Allegra, antihistamine, $67 million
10. Meridia, weight loss, $65 million
11. Flovent, asthma, $63 million
12. Pravachol, high cholesterol, $62 million
13. Zyrtec, antihistamine, $60 million
14. Singulair, asthma, $59 million
15. Lipitor, high cholesterol, $59 million
16. Nasonex, nasal allergies, $53 million
17. Ortho Tri-Cyclen, oral contraceptive, $47 million
18. Valtrex, genital herpes, $40 million
19. Lamisil, toenail fungus, $39 million
20. Prempro, hormone for osteoporosis, menopause symptoms, $38 million
Top 20 Best-Selling Drugs 2010
In spite of difficult market conditions and patent expiry of several blockbuster drugs, the global pharmaceutical markets expanded to $850 billion in 2010.
In spite of increased generic and new arrival competition, Lipitor retained its top position as the best selling global drug brand in spite of sales decline and competition from generic statins. It was followed by Plavix and Remicade. Plavix became the second drug to have annual sales of over 9 billion dollar. Remicade emerged as the best selling biologics in 2010 and goes ahead of Enbrel by sales.
Roche remains the top company by sales of biologics, anticancer and monoclonal antibodies. As in previous years, companies reported sales differed by over 1-3 billion dollars from the IMS Health reported figures. IMS has over reported sales of Nexium and under reported sales of top biologics during the past few years.
#1 LIPITOR
Treats: High cholesterol
Pfizer $8.4 billion +8%
#2 ZOCOR
Treats: High cholesterol
Merck $4.4 billion (2005 sales) -5%
#3 NEXIUM
Treats: Heartburn
AstraZeneca $4.4 billion +15%
#4 PREVACID
Treats: Heartburn
Abbott & Takeda $3.8 billion -2%
#5 ADVAIR DISKUS
Treats: Asthma
GlaxoSmithKline
$3.6 billion +22%
#6 PLAVIX
Treats: Heart disease
Bristol-Myers Squibb & Sanofi-Aventis
$3.5 billion +15%
#7 ZOLOFT
Treats: Depression
Pfizer $3.1 billion -2%
#8 EPOGEN
Treats: Anemia
Amgen $3.0 billion -1%
#9 PROCRIT
Treats: Anemia
Johnson & Johnson $3.0 billion -9%
#9 PROCRIT
Treats: Anemia
Johnson & Johnson $3.0 billion -9%
#11 ENBREL
Treats: Rheumatoid arthritis
Amgen & Wyeth $2.7 billion +36%
#12 NORVASC
Treats: High blood pressure
Pfizer $2.6 billion +8%
#13 SEROQUEL
Treats: Schizophrenia
AstraZeneca $2.6 billion +25%
#14 EFFEXOR XR
Treats: Depression
Wyeth $2.6 billion -2%
#15 ZYPREXA
Treats: Schizophrenia
Eli Lilly $2.5 billion -16%
#16 SINGULAIR
Treats: Asthma & Allergies
Merck $2.5 billion +14%
#17 PROTONIX
Treats: Heartburn
Wyeth $2.4 billion +0%
#18 RISPERDAL
Treats: Schizophrenia
Johnson & Johnson $2.3 billion +5%
#19 NEULASTA
Treats: Chemotherapy side effects
Amgen $2.2 billion +30%
#20 REMICADE
Treats: Rheumatoid arthritis
Johnson & Johnson $2.2 billion +12%
Fastest-Growing Drugs
#1 VYTORIN
Treats: High cholesterol
Merck & Schering-Plough $917 million +913%
#2 CYMBALTA
Treats: Depression
Eli Lilly $667 million +727%
#3 AVASTIN
Treats: Colorectal cancer
Genentech $948 million +247%
#4 MOBIC
Treats: Arthritis pain
Boerhinger Ingelheim $1.1 billion +116%
#6 HUMIRA
Treats: Rheumatoid arthritis
Abbott Labs $857 million +59%
#7 HERCEPTIN
Treats: Breast cancer
Genentech $750 million +52%
Source: IMS Health, a healthcare information company. Twelve Months
Ending December 2005
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