By Charlotte E. Sibley

Introduction

The Coalition for Healthcare Communication has keenly monitored the debate on Direct-to-Consumer Advertising (DTCA), and recommended conducting a study to assess the impact of DTCA on consumers and physicians.

A number of studies have been conducted assessing DTCA; however, due to the different sponsors, methodologies and objectives of the various studies, there is no comprehensive understanding of DTCA's impact. Isis Research Inc. was commissioned to review all DTCA studies available in order to:

-- present key findings
-- compare results across studies
-- determine key areas not addressed in the research
-- uncover areas of bias
-- suggest next steps

The studies reviewed represent the following sponsors:

Time Magazine: 1998 and 1999
Prevention Magazine: 1998 and 1998
Wall Street Journal
National Consumers League
Health Medical Consumer
Parade Magazine (on OTC medications)
Web-based company
Age Wave Mature Market
Scott-Levin (among physicians)

Time Inc. 1999 Consumer Attitudes Toward Direct-to-Consumer Advertising

Key Findings:

• DTC advertising does not seem to have compromised the doctor-patient relationship:
• 2 of 3 consumers still rely on healthcare professionals for healthcare advice and information
• 8 in 10 agree that the doctor knows best and always follow doctor's orders. 1 in 3 always wants a second opinion
• However, the trend in self-care continues, with 8 in 10 concurring that they: like to know all options and decide for themselves; like to discuss choices/what to do
• Awareness of DTC advertising increased from the 1998 study for each condition listed.

About 20% spoke with a healthcare professional as a result of seeing an ad in a magazine; another 20% after seeing an ad on TV; and 20% after seeing/hearing an ad in other sources (newspapers, mail, radio, Internet). Of those who spoke with a healthcare professional, 1 in 3 had a discussion during a visit to the doctor, and about 15% discussed by telephone.

An additional 34% discussed the ad with a friend, while about 10% visited a Web-site or called the 800 number.

31% claim to read the Brief Summary:
48% read all,
31% read most,
19% read some

Information read in the Brief Summary is primarily on side effects, followed by indications, dosage/administration, and drug interactions.

At least 50% of consumers want advertising that:

clearly states all associated risks (73%)
tells about symptoms (I ) can discuss with doctor (62%)
tells about new treatment options (61%)
contains all the information needed (60%)
prevents children from seeing (58%)
makes (me) aware of new Rx drugs available (56%)
can take time to study (52%)
provides an 800# (50%)

can be viewed privately (43%)
information can be shared with others (40%)

(Note: Most percentages are lower than in 1998 study.)

Magazines and TV were rated about equally well on all these attributes, except on "can take the time to study", where magazines scored higher.

Respondents claim TV as the most frequent source of awareness of DTC.

In contrast to the 1998 study, which asked only for the extent of agreement with the statement "I would switch doctors to get desired medication", the 1999 survey explored the issue in the context of the condition involved. There is greater agreement on switching doctors for less serious illnesses, such as heartburn and allergies (50% would switch) than for more serious diseases, such as depression, where no more than 24% would switch. Interestingly, only 7% with impotence would switch.

Still, one-third believe they can choose the appropriate medicine without their physicians' advice - the same proportion as in 1998.

Just over 20% received a prescription for the DTC drug discussed with the physician.

Over 80% of consumers filled the prescription:

63% represent a new Rx

If the consumer does not receive a scrip, it is most likely because he/she does not have that condition (33%) or the drug is not appropriate - although the reasons are not probed.

Consumers visited the doctor an average of 3.6 times in the last 12 months; 69% were "already sick", while for 31%, the visit occurred prior to getting sick. It is not clear where the exam is accounted for.

ISSUES

Sponsored by Time magazine
"Coached" by the FDA:

issues of importance to the FDA are included (e.g., doctor/patient relationship)
wording of some questions is biased
lack of follow-up probing to key questions
lack of market research expertise among FDA advisors
There is the not uncommon disconnect between attitudes and behavior: for example, 50% of consumers say they want an 800 number, but only 8% actually called.

Questions on attitudes toward including disease symptoms and available treatments in DTC ads were added in the 1999 study based on doctors' feedback in the 1998 study.

Who: 1000 adults 18+ years
When: March - April 1999
How: Telephone interviews

Time Inc. 1998 Direct-to-Consumer Advertising Study: Consumer and Physician Attitudes

Key Findings: Consumers

Diseases reported most frequently are:

Allergies (33%)
Arthritis (21%)
Hypertension (17%)
High Cholesterol (12%)
Migraine (11%)
Depression (10%)

Physicians are the gatekeepers (84% agree "My doctor knows what is best"), but 1 in 3 consumers feels that he/she controls the doctor/patient relationship:

32% "believe I can choose medication without my doctor's advice" (11% agree completely)

28% "would switch doctors to get desired medication" (11% agree completely)

Awareness is highest for ads for allergy drugs (64%), followed by arthritis products. About one-third are aware of ads for asthma, migraine and high cholesterol drugs.

Advertising awareness is higher among sufferers: especially for arthritis, asthma, high cholesterol, depression, birth control, diabetes and menopause.

There is lower correlation than expected between advertising spend and claimed source of ad recall:

recall of TV as the source of advertising is generally higher than for print, although print advertising expenditures dominate in most categories - except allergies, migraine, and asthma; stronger correlation does exist in the categories of birth control and menopause, where dominant print spend is reflected in higher claimed awareness; for depression, where virtually all spend was in magazines/print, there was somewhat higher recall of magazines as source.

20-30% claimed receipt of Rx (based on speaking with healthcare professionals):

29% from magazine ad
23% from TV ad

When the respondent does not receive a prescription, it is generally because the drug is not appropriate:

drug not appropriate (29%)
does not have condition (16%)
has another condition so can't take drug (9%)
doctor suggested something else (6%)

35% claim to read the detailed information on back of print ads:

especially among sufferers of arthritis, depression, skin/fungal infections, diabetes -- and particularly so for birth control.

58% say magazines are the most appropriate medium for Rx advertising.

Key Findings: Physicians

Most MDs (60%) are aware of advertising for allergies, high cholesterol, migraine, smoking cessation, fungal infections, and osteoporosis:

about half are aware of ads for HRT, herpes, birth control

40% for asthma, depression, HTN, arthritis, ED; 18% for HIV/AIDS

A minority (15%) feels DTC is extremely beneficial, while a similar proportion says it is not at all beneficial:

38% say somewhat beneficial
33% say not very beneficial

Disease symptoms head the list of information doctors want included in DTC:

disease symptoms (69%)
direct consumers to see MD for additional information (59%)
available treatments (58%)
specific indication or use (48%)
major statement of side effects (44%)

Less important to include are the 800 number and Internet address.

MDs favor DTC to help educate consumers and to encourage them to seek treatment:

alert consumers to Rx products available (85%)
encourage consumers to seek medical treatment (67%)
provide consumers with needed information (61%)
help in MD's efforts to provide best treatment (40%)

MDs are averse to DTC because it can lead to unnecessary/incorrect medicines:

leads patients to request unnecessary/incorrect medications (88%)
puts pressure on MDs to write Rx per patient request (74%)
confuses consumers about differences between Rx and OTC drugs (68%)
confuses consumers about risks associated with Rx medications (69%)
confuses consumers due to having too much information (56%)

30% of MDs claim patients bring in either magazine ads/articles or newspaper articles:

23% bring in newspaper ad
17% Internet
6% TV ad

Issues:

Sponsored by Time magazine

"Coached" by the FDA

Use of some "loaded" questions with no follow-up exploration (e.g., switching doctors to get desired medicine; choosing medication without doctor's advice)

Consumers:

Who: 1500 adults 18+ years
When: March-April, 1998
How: Telephone interviews

Physicians:

Who: PCPs and 6 Specialties (Allergists, CDs, PSYs, UROs, OB/GYNs and PEDs)
When: March-April 1998
How: Mail questionnaire

Year Two: A National Survey of Consumer Reactions to Direct-to-Consumer Advertising

Summary and Projections:

As many as 176.7 million Americans have seen or heard a DTC advertisement.

About 54.8 million people talked with their doctor about advertised medicines.

As many as 15.3 million asked their doctor for a prescription specifically because they saw or heard a DTC ad for that product.

Approximately 12.9 million consumers received a prescription as a result of seeing an ad.

About 24.7 million talked for the first time with their doctor about conditions like allergies, heart disease and diabetes as a direct result of DTC ads.

Doctors honor patients' requests for advertised medicines 8 out of 10 times.

Key Findings:

As in the 1998 study, consumers are still positive overall toward DTC advertising, primarily because DTC provides them with the information necessary to help meet their self-care goals. There is a high level of agreement that DTC:

helps them to be more involved in their own health care (76%)
educates them about risks and benefits of Rx medicines (72%)
helps people make their own decisions about Rx medicines (63%)

On the negative side, almost half of consumers are concerned that DTC advertising makes Rx medicines seem harmless, and 39% voice concern about creating tension between doctors and patients.

The trend to self-care continues: 8 in 10 consumers report taking vitamins and minerals, while 50% claim to use herbal remedies.

95% of consumers have now seen or heard a DTC ad (for any of 13 specific products):

women have higher recall of ads than men mature consumers (especially those 74+ years) are less likely to recall seeing an ad.

The gap in awareness between consumers using Rx medicines and those who are not has virtually disappeared.

DTC advertising is still not doing a particularly good job of informing consumers about specific indications:

96% of consumers who suffer from or are at risk of specific conditions do not know the indication of advertised products, even when the product is specifically for them

81% are aware of DTC advertising, up from 70% in 1998 and 63% in 1997:

"old matures" (aged 74-90) have lowest awareness

Public awareness of informational advertisements (those that discuss a medical condition or illness without mentioning a specific treatment) is virtually unchanged since 1998 (33% vs. 32%, respectively).

A majority of consumers recall seeing or hearing a DTC ad for Claritin (75%), Zyban (68%) and Allegra (66%), while slightly more than half recall ads for Propecia (55%). Recall for other products is lower:

Meridia 45%
Zyrtec 43%
Zocor 35%
Premarin 30%
Prilosec 29%
Accolate 21%
Imitrex 20%
Detrol 20%
Glucophage 13%

Correct identification of the brand with the condition is highest for Claritin - allergies (60%); about half of consumers correctly link Propecia with hair loss, Glucophage with diabetes and Premarin with hormone replacement. Sufferers usually have higher correct identification scores.

Of the top 5 advertised brands in terms of spend (1Q 1999), 4 also achieved top-5 awareness levels: Claritin, Zyban, Propecia and Meridia. Only Allegra does not score among the leaders on awareness.

2 in 10 consumers who have seen DTC ads think they are very clear about product indications; 47% think the ads are somewhat clear.

4 in 10 adults think DTC ads do an excellent/good job providing risk information; no significant difference exists between magazines and TV.

6 in 10 say that DTC ads included the risk and benefit information needed to talk to their doctor.

54% of those who have seen DTC ads in magazines noticed the Brief Summary:

24% read the Brief Summary of looked for information in it

10% ignored it

40% are unaware it exists

3 in 10 consumers look for information about side effects in the Brief Summary page; about 15% look for precautions against taking the product or warnings for people with health conditions.

Of the information included in the DTC ad, recall of the statement to speak with a doctor or pharmacist is by far the highest: speak with MD/RPh 92%
toll-free number 69%
Web-site address 48%
referral to print ad 27%
referral to the PDR 25%*

*dummy variable

A discussion with the doctor is the most frequent action taken (33%); no more than 1 in 10 referenced any other source of information (toll-free #, Internet, print ad).

31% of consumers who have seen/heard a DTC ad have spoken with their doctor about the advertised medicine:

81% during a regular appointment
10% by telephone
7% by special appointment

Consumers are as likely to talk with their doctor about a medicine for someone else as they are to discuss medicines for themselves (62%):

6 in 10 spoke with the doctor because they learned something about another medicine they could take (instead of the one taking now)

4 in 10 learned something about the drug being taken already

8 in 10 say their doctor is very willing to talk about the advertised medicine; only 5 % of physicians are not willing to discuss.

28% asked for a prescription for the advertised product:

7% asked for additional information

84% received an Rx for the advertised medicine.

Only 7% of consumers completed the entire DTC to Rx process:

saw/heard an ad
and spoke with their doctor
and asked for the scrip
and received the scrip

14% of adults who have seen/heard a DTC ad talked with their doctor about medical conditions they had not previously discussed. Diseases asked about are:

allergies 13%
acid reflux 7%
diabetes 6%
migraine 5%
heart conditions 5%

Almost half (46%) of adults are taking a prescription medicine;

29% take more than one

One-third think Rx drugs are very safe;

51% say somewhat safe

37% of adults who have seen a DTC ad for the drug they are taking say the ad makes them feel more confident about the safety of their medicine;

52% say the ad makes them feel better about the benefits of their drug

DTC advertising may improve patient compliance:

31% say they are more likely to take their medicine

33% say the ad reminded them to have the prescription refilled

Issues:

Sponsored by Prevention magazine
"Technical assistance" from DDMAC at FDA
Some "loaded" questions (DTC advertising "creates tension…"; "confuses people…")

Who: 1200 adults 18+ years
When: March-April 1999
How: Telephone interviews

National Survey of Consumer Reactions to Direct-to-Consumer Advertising

Key Findings:

The majority of adults self-treat for less serious diseases:

headache (87%)
heartburn (84%)
fever (77%)
diarrhea (76%)
cold/congestion (76%)
menstrual cramps (71%)
muscle pain (69%)

For allergies/asthma/sinus and yeast infections, consumers are equally likely to self treat or visit the doctor.

For more serious conditions such as chest pain (79%) or toothaches (68%), consumers first contact a doctor.

Consumer attitudes toward DTC advertising are generally positive, but some feel that DTC ads can also "confuse" people or minimize risks:

Strongly/MostlyAgree allows people to be more involved with their health care 74%

educates people about the risks and benefits of Rx medicines 67%

confuses people about the risks and benefits of Rx medicines 61%

makes Rx medicines seem harmless 55%

helps people make their own decisions about Rx medicines 59%

causes tension between doctors and their patients 38%

32% have seen an "informational" ad - i.e., one that talks about medical conditions but does not mention specific treatment.

70% have seen an ad for an Rx medicine (vs. 63% in 1997 study):

48% have seen ads that mention both the product name and the indication.

Consumers who are currently taking an Rx medicine (and those who have or are at risk of developing the condition) are more likely to recall seeing an ad - especially for allergies and HRT, as well as for high cholesterol and migraine

matures (age 53+) have lower recall vs. Boomers and Generation X

Highest awareness is for:

Prozac (73%)
Claritin (63%)

Reflecting the limitations on advertisers, Prevention concludes that "DTC ads for Rx medicines are not doing a good job of telling consumers about the health problems they are intended to treat …even among sufferers. The large majority of the target audiences for Pravachol (79%) and Zocor (66%) do not know the indication for either of these medicines, despite having seen advertisements for them."

Recall of the source of DTC ads is highest for TV:

TV 77%
magazines 63%
radio 23%
newspapers 30%

Only 21% of consumers think DTC ads are very clear; 45% say somewhat clear:

matures are less likely to think the ads are clear
consumers who have seen ads that include both the product name and intended condition are more likely to say DTC ads are very clear

4 in 10 think DTC ads do an excellent/good job of communicating both "annoying but not serious side effects" and "serious warnings about the product":

2 in 10 think the ads do a poor job

38% talked with a doctor after seeing an ad on TV.

A large proportion recalled specific information in the DTC ad:

additional info available from MD or pharmacist 85%
toll-free number 71%
Web-site address 48%
magazine/newspaper ad 24%
PDR* 23%

* dummy variable; not mentioned in DTC ad.

43% sought additional information:

talked with MD 33%
asked MD about condition 13%
went to magazine or newspaper ad 10%
got on Internet 10%
called toll-free number 10%
none 54%

45% claim to read almost all of the Brief Summary in print advertising:

23% read some, 30% read little or none claimed readership is particularly high among those with osteoporosis and depression, followed by HTN and arthritis

33% spoke with their doctor about a specific advertised drug:

13% spoke with MD about a medical condition/illness not previously talked about

those already on an Rx drug are significantly more likely to talk with their doctor about an advertised medicine

8 in 10 consumers say their doctor is willing to talk; only 5% say their MD is unwilling.

Consumers most frequently request allergy medicines -- but all percentages are low*:

Claritin 16%
Prozac 7%
Allegra 6%
Prilosec 5%
Imitrex 3%

*Based on the one-third who discussed specifically with their doctor.

28% asked for a prescription;

70% asked for more information

80% of doctors honored the request for a prescription.

DTC ads seem to bolster the perception that Rx medicines are safe:

communicating risk information makes 25% of consumers have more confidence in the medicines they take; 20% have less

DTC ads may boost compliance: 25% report that DTC ads make them more likely to take their medicine and remind them to have their Rx refilled.

2 in 3 consumers almost always get information on side effects - equally often from the doctor and the pharmacist:

about half "almost always" get information on (drug) benefits (usually from the doctor), and on possible interactions between the prescribed drug and another medication they are on (equally from the doctor and the pharmacist)

slightly fewer than half get information on the generic brand and on possible interactions between the prescribed drug and OTC products; the pharmacist is usually the source.

Professionals (physicians and pharmacists) are by far the key trusted sources of accurate information, mentioned by 2 in 3 consumers:

medical journals, books, and family/friends also play a role, cited by 20-30%.

Issues:

Sponsored by Prevention magazine
Received "FDA assistance"

Who: 1200 adults 18+ years
When: March-April, 1998
How: Telephone interviews

Picture of Health: A Study of Wall Street Journal Subscribers

Key Findings:

While 75% of readers look to professionals (physicians, pharmacists) for information on healthcare, medical conditions and medications, almost 9 out of 10 claim to acquire their information from publications. Seven in 10 mention the Wall Street Journal specifically.

Claimed recall of DTC advertising is higher for print media (86%) - especially the WSJ (38%) -- than for TV (60%).

81% report they would consult a medical professional (primarily the physician) after seeing an ad for a new medical treatment "that could help you or another household member". Only 6% would do nothing.

60% actually took action:

42% discussed with doctor
14% discussed with pharmacist
29% discussed with friend or relative

Intention does not necessarily match behavior, however:

Reported action taken is less frequent than intention to act in terms of consulting a physician (80% intent vs. 42% reported), but more frequent in the case of consulting family/friend (16% intent vs. 29% claimed behavior).

Issues:

The WSJ subscriber is not representative of the general population in terms of education (83% college graduates, 41% post-graduate);
income (average $200,000+); age ( average 52); gender ( male 81%);
and insurance status (77% have all or most health care coverage paid by employer).

Who: 2000 Subscribers (55% response rate)
When: February-March, 1997
How: Mail questionnaire

National Consumers League: Healthcare Information and the Consumer

Key Findings:

The main sources of health information are:

magazines (34%)
healthcare professional (33%)
television (28%)
newspapers (24%)
books/ medical books (22%)
internet (12%)
family and friends (11%)

4 out of 5 have heard or seen a DTC ad, mostly from television:

television (88%)
magazines (50%)
newspapers (23%)

32% claim to read almost all of the Brief Summary:

24% read some
42% do not read

Consumers generally agree that DTC ads increase their knowledge about medicines, but are less convinced that DTC increases knowledge about the disease.

44% have discussed a DTC medicine with a physician: especially older consumers, females, and those with higher incomes

Fewer (23%) have discussed a disease with their doctor.

About 2 in 10 received a prescription as a result of the discussion:

23% received Rx
13% did not get Rx
12% drug not appropriate
5% got Rx for another drug

23% agree that herbal supplements are as effective as Rx or OTC medicines;

37% disagree

Information included with the prescription considered most useful is:

complete information on side effects, rashes, and possible interactions (52%)

summary of most important but not all side effects and interactions (32%)

72% claim to have read all the information:

40 - 50% felt it was useful, easy to understand and complete

Who: 1,013 Adults 18+ years
When: August 1998
How: Telephone interviews

Health Medical Consumer (HMC) Advertising & Marketing Survey

Key Findings:

A majority of consumers agree that TV advertising is suitable for such "personal" conditions as sexually-transmitted diseases, contraception, weight loss, depression and enlarged prostate.

Issues:

Reported in the Television Bureau of Advertising (TVB) Guide for Pharmaceutical Advertisers

When: Reported in 5/98 DTC Times

PARADE Health Report: Over-the-Counter Medications

Key Findings:

60% say with minor ailments, they often/always prefer to choose an OTC medication rather than go to a doctor:

but only when they feel comfortable with the situation (80% will call/see a doctor if at all unsure)

More than 4 in 5 say they always read directions on labels before using a product for the first time (especially women).

2 in 3 say they understand information on labels.

The most frequently used OTC products are for headache and heartburn/indigestion, followed by yeast infections, hemorrhoids, cough and sore throat.

Conditions not being treated with OTCs are hair loss, followed by depression, sleeplessness, and foot/toenail fungus.

Effectiveness is the most important factor in product selection.

Most consumers favor Rx-to-OTC switches, believing that switches:

are safe (73%)
save money (71%)

Almost 80% are likely to choose an OTC brand they are familiar with when available by Rx.

38% claim to be using more OTC medicines than in 1995.

Issues:

Presented at 1997 NDMA Annual Meeting
Sponsored by Parade magazine
Note that self-medication is not mentioned for allergies, the leading DTC category.

Who: 1500 adults (18+ years)
When: Spring 1997
How: Telephone interviews

Direct-to-Consumer Advertising on the Web: A Prescription for Success

Key Findings:

54% of consumers report visiting a Web-site operated by a pharmaceutical company to learn about a specific Rx drug.

63% report requesting an Rx drug by brand name.

Consumers claim to get most of their information on Rx medicines from doctors (24%), pharmacists (18%), and the Worldwide Web (17%).

Consumers consider the quality of information on a pharmaceutical company Web-site to be superior to other sources (information in ads in all other media; friends/relatives; news reports; patient advocacy groups; and HMOs/insurance providers).

Issues:

Biased sample and methodology: survey conducted using the Internet among Web-based sample to evaluate the potential for DTC advertising on the Web.

Who:
Panel of 1,026 consumers
Panel of 508 medical professionals (48% MDs)

When: Spring 1999

How: Internet /on-line survey

The Age Wave Mature Market Study

Key Findings:

More than 9 out of 10 recalled seeing/hearing a DTC ad.

35% discussed and ad with their primary care physician, 17% spoke to their pharmacist.

33% of those who had discussions received an Rx.

28% talked to their doctor because of a TV ad:

26% because of a magazine ad

18% from a newspaper ad.

Almost half of consumers are most likely to respond to ads for Rx drugs on TV vs. 20% for ads in magazines.

Who: 2,965 Adults 50+ years
When: 1998

Scott-Levin Direct-to-Consumer Advertising (among physicians)

50% of physicians expressed negative attitudes towards DTC ads (1996, 1995, 1992, and 1989 studies).

1 in 3 doctors is likely to prescribe a requested drug (13% very likely, 19% likely).

Beta Research Direct-To-Consumer Advertising

71% of consumers questioned contacted a tor as a result Of seeing a prescription drug ad in the past six months. (9/98)

Medical Measures Inc.
Consumer Awareness and Response to Direct-To-Consumer Advertising

23% of respondents said that advertisement provided new information about treatment.

19% of consumers contacted a doctor for the first time as a result of seeing an advertisement.

Update: Additional Studies

Time Inc. 2000:
Measuring the Awareness and Impact of Direct-to-Consumer Advertising

Prevention Magazine 2000:
Direct-To-Consumer Advertising Study

Reader's Digest: Healthcare 2000

____________________________

This review was prepared by Charlotte E. Sibley. At the time she was
President,
ISIS RESEARCH (US)
Princeton, N.J. 08540

Currently, Ms. Sibley is
Vice President, Market Research
Pharmacia
Peapack, N.J. 08809