Direct-To-Consumer Advertising : Is It Creating Well-Informed or Mislead, Unduly Influenced Patients?

Donna DohertyJeanne Ulmer

Leslie PirtleMHC 750 JH01

March 2008

Introduction

• Youtube Act 1

• Youtube Act 2

http://neatorama.cachefly.net/images/2006-07/vintage-drug-ads.jpg

FDA issuesGuidelines

FDA requests voluntary

Moratorium

1st D-T-C Rx drug ad in US

13.5% D-T-Cads are on TV

FDA relaxesrules

governingTV ads

63.8% D-T-Cads are on TV

http://www.cato.org/pubs/regulation/regv29n1/v29n1-7.pdf

FDA Oversight

• The FDA regulates the promotion of prescription drugs, including the content of DTC advertisements

• Requires that advertisements present accurate information and fairly represent both the benefits and risks of the drugs being advertised

• In 1997 the FDA issued draft guidance to clarify and offer options on how these regulations applied to DTC advertisements on radio and television.

• FDA reviews ads that will reach a wide audience-this includes all TV ads

• Sent warning letters to violating companies for 5% of ads between 97 and 00

http://content.healthaffairs.org/cgi/content/full/hlthaff.w3.120v1/DC1

YearSpending on DTC

advertising

Spending onpromotion to physicians

Retail value of samples

R & D

1997 $1.1 $3.9 $6.0 $15.5

2000 $2.5 $5.6 $8.5 $21.4

2003 $3.3 $7.4 $13.5 $27.1

2004 $4.0 $7.8 $15.9 $29.8

2005 $4.2 $7.2 not available $31.4

Avg annual % increase

19.6 9.0 14.9 9.3

Total % increase, ‘97-’05

296.4 86.0 162.4 103.3

Table 1: Prescription Drug Promotion and Research and Development, 1997-2005. (Source: U.S. Government Accountability Office, Prescription Drugs: Improvements Needed in FDA's Oversight of Direct-to-Consumer Advertising', GAO report Number GAO-07-54, December 14, 2006.

Spending on DTCA 1997-2005 Spending on DTCA 1997-2005

Some Facts

• "Up until 1997, manufacturers could not say both the product's name and what it was used for, in a TV ad"

• Today, over 196-million consumers have seen a DTC advertisement

http://www.magazine.org/Research/7973.cfm

http://www.cato.org/pubs/regulation/regv29n1/v29n1-7.pdf, p.3

TV Drug Ads Legal In Only 2 Countries

• New Zealand

• United States

Types of D-T-C Ads

• Product-claim ads

• Reminder ads

• Help-seeking ads

http://www.fda.gov/fdac/features/2004/404_ads.html

http://www.fda.gov/cder/ddmac/P3Benzing/sld023.htm

http://www.fda.gov/cder/ddmac/P3Benzing/sld023.htm

2 Types of Data

• Impact of D-T-C advertising on patients

• Impact of D-T-C advertising on physicians

http://democracyinaction.org/dia/organizations/commercialalert/campaign.jsp?campaign_KEY=1415&t=stop_drug_ads_home.dwt

Pro Direct-To-Consumer

• Educates Patients• Prompts to see physician• Prompts patients to talk about conditions they

might not otherwise talk or know about• Freedom of speech—can’t stop it• Ultimately reduces costs by prompting early

treatment• Alerts patients to disease they were unaware that

they had• Empowers consumer to become more active

participant in their own care

Pro Arguments-Consumers

• Nearly  two-thirds of consumers agree that DTC advertising is done responsibly

• Approximately two-thirds of consumers have talked with their doctors about a prescription drug as a result of DTC advertising. 

• Approximately 20-million have had three or more of these conversations

• 2002/1 in 5 Americans were prompted to contact MD to discuss a D-T-C advertised drug (Gottlieb,BMJ,2002)

• 1999, 15.3 million Americans requested D-T-C advertised drugs/12.9 million received the drug,(Mintzes,2001)

http://www.magazine.org/Research/7973.cfm

Pro Arguments-Doctors

• Facilitates patient-provider communication• Prompts patients to discuss symptoms more openly• 41%of MD’s reported improvement in patient awareness of

treatment as well as improved discussion, (Aikin et al,2004)• 39% of 643 MD’s prescribed a drug requested by a patient

as a result of an advertisement• 46% of the MD’s who had prescribed a patient requested

drug felt it was the most effective treatment for the patient’s condition (Health Affairs,4/04)

• Promotes need for MD’s to remain educated about drugs to inform patients

• Prompted patients to see their physician• Strengthens provider-patient bond

Pro Arguments-Rx Industry

• Its patients right to know and choose

• Empowers patients w/information

• Urge patients to seek treatment

• Promotes early treatment and diagnosis and reduces spending on medical services such as hospitalization

DTC communications about prescription medicines serve the public health by:

• Increasing awareness about diseases• Educating patients about treatment options• Motivating patients to contact their physicians

& engage in a dialogue about health concerns • Increasing the likelihood that patients will

receive appropriate care for conditions that are frequently under-diagnosed and under-treated

• Encouraging compliance with prescription drug treatment regimens.

The Pharmaceutical Research and Manufacturers of America (PhRMA)

1. Premise of the Principles2. Compliance with FDA Regulations3. Responsible Education about the

Medicine and/or Health Condition4. Clear Indication that the Medicine is a

Prescription Drug5. Encouragement of Communication between

Patients and Health Care Providers6. Education of Health Care Providers Prior to

Launch of Advertising Campaign7. Alteration or Discontinuation of an Advertising

Campaign

The Pharmaceutical Research and Manufacturers of America (PhRMA)

8. Submission of DTC Television Advertisements to the FDA Prior to Broadcast

9. Information on Other Treatment Options

10. Information about the Medicine’s Approved Purpose and Major Risks

11. Balanced Representation of Benefits and Risks

12. Respect for the Seriousness of the Medicine and Health Condition

13. Avoiding Audiences that are Not Age-Appropriate

14. Promotion of Health and Disease Awareness

15. Information about Help for the Uninsured and Underinsured

Cons…

• Appeals to emotions

• Misleading

• Understates risks & side effects

• Benefits are overstated

• Influences patients to ask for meds they don’t need

• Spend money on brand names

Cons…

• Conditions that aren’t conditions

• physicians under pressure to prescribe drugs unnecessarily.

• Undermines physician-patient agency relationship

• Bribery from drug companies

Cons…

• Telling healthy patients they are sick!

• Consumers lack the safety and efficacy information they need to make informed decisions

• FDA oversight is too weak

Prevention vs Risk Reduction

Making Health Decisions Based On TV…

US$1.20US$2.20US$3.20US$4.20

In the year 2000, how much did each dollar spent on direct-to-consumer advertising of prescription drugs in the United States yield in additional pharmaceutical sales?

US $1.20

US $2.20

US $3.20

US $4.20

http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371%2Fjournal.pmed.0030239&step=question&qid=Q1&x=34&y=21

Based on the 2003 European guidelines on cardiovascular disease prevention, what proportion of Norwegian adults would be labeled as having an “unfavorable” cardiovascular risk profile?

26% 56% 76%

How much did drug companies spend in 2004 in Europe on “disease awareness” campaigns (unbranded disease-specific consumer advertising)?

US $25 million

US $85 million

US $125 million

The Pfizer Web site states that sildenafil (Viagra) “works” for what proportion of men?

20% 40% 60% 80% 100%

10%–20% of the time

50%–60% of the time

80%–90% of the time

On its Web site, Pfizer states, “VIAGRA can work for you. In fact, studies show that VIAGRA works for more than 80% of men with ED [erectile dysfunction] taking VIAGRA 100 mg versus 24% of men taking a sugar pill”?

Men between the ages of 18 and 45 years

Men between the ages of 45 and 60 years

Men over 60 years

Between 1998 and 2002, the group showing the largest increase in Viagra use was men between the ages of 18 and 45, and only one-third of these men had a possible etiologic reason for needing Viagra

There is good evidence from long-term studies that these drugs can improve the quality of life of people with Alzheimer disease

Memantine is a good option for all patients with Alzheimer disease

Donepezil, galantamine, and rivastigmine should be reserved only for people with Alzheimer disease of moderate severity (i.e., those with a Mini-Mental State Examination (MMSE) score between ten and 20)

Which of the following best reflects the latest Appraisal Consultation Document from the United Kingdom National Institute for Health and Clinical Excellence (NICE) on prescribing cholinesterase inhibitors?

The drug has been approved in Europe, Australia, and the US

The European Medicines Evaluation Agency refused to approve fluoxetine for PMDD

The Australian federal government agreed to cover the costs of Sarafem

Eli Lilly's advertising of Sarafem has never been in violation of US law

Which of the following is true about fluoxetine (Sarafem), a treatment for “premenstrual dysphoric disorder” (PMDD)?

13%

23%

33%

43%

According to a widely cited 1999 study in the Journal of the American Medical Association on the prevalence of female sexual dysfunction by Laumann and colleagues, what proportion of women aged 18–59 years suffers from female sexual dysfunction?

Pfizer attempted to have sildenafil (Viagra) approved to treat female sexual arousal disorder, but its quest ended because of consistently poor clinical trial results

There are no reports of Viagra being prescribed to women off label

In 2004, an FDA advisory panel voted unanimously to approve a testosterone patch for women (Intrinsa) to treat “hypoactive sexual desire disorder”

Which one of the following statements is true about drug treatments for female sexual dysfunction?

Warning…..This lecture has been known to cause hair raising experiences in a small percentage of the population. If this side effect should occur seek the advice of a professional Beautician immediately or visit your doctor and ask for a DTC drug!