More advertising leads to more requests for advertised medicines (See here). Following DTCA, prescriptions of some drugs have risen by over 50%. These drugs are marketed as innovations or therapeutic advances; however, most new drugs have no therapeutic advantages over existing alternatives See here, here, here, and here). In many cases, prescription medications that are the subject of DTCA are later associated with more detrimental and, sometimes, fatal adverse effects, as opposed to medications that are not the subject of DTCA, simply because more people request and take the advertised medications. When companies use DTCA to "educate" consumers and physicians, they often overstate medications' benefits, and understate the associated risks.
DTCA affects physicians' prescribing choices and patients' requests for medications. DTCA affects prescribing volume and product choice. For example, patients who requested DTCA drugs were almost 17 times more likely to receive prescription medications, compared with patients who did not request medications. Approximately 9/10 patients who request DTCA drugs received prescriptions for their requested drug or an alternative.
The pressure felt by physicians to prescribe to patients upon request cannot be ignored. A 2002 survey of 1,975 physicians showed that 67% (1,204/1,975 physicians) sometimes or often felt pressured to prescribe advertised medications. In another study, 50% of prescriptions requested by patients, for DTCA drugs, were deemed by physicians to be either "possible" or "unlikely" choices for similar patients (See here). DTCA is problematic because advertisements do not provide consumers with sufficient information about both the benefits and risks of medications. Neither patients, nor physicians, obtain sufficient information from advertisements to accurately self-diagnose or diagnose, respectively, or to choose the best, safest, and most cost-effective alternative treatments. Furthermore, advertisements provide neither physicians, nor patients, with the appropriate evidence- and data-based information to make informed prescribing choices. Adequate information on adverse events, contraindications, and drug interactions are not provided through advertisements. (See here.)
The regulation of DTCA differs by country. There are three primary types of DTCA that are considered in discussions about the regulation of direct-to-consumer advertisements of prescription medications (see here):
- "Disease-awareness advertisements": Advertisements that provide audiences with information about a specific medical condition and encourage patients and consumers to talk to their physician about treatments. [Legal in Canada and US]
- "Reminder advertisements": Advertisements that state the name of a medication and may provide information about the strength, dosage, form, and pricing, but may or may not mention the medication's indication (the condition for which it was approved to treat), and may or may not make claims about the product's effectiveness. [Legal in Canada and US with few exceptions]
- "Product claim advertisements": Advertisements that combine the brand name of the drug with claims about its indications and effectiveness. [Legal in US, not Canada]
In no case is it legal to advertise medications for off-label indications, or uses for which medications are not approved by the regulating health agency.
For more information on DTCA, please see the below articles and the previous post on DTCA. The regulation of DTCA of prescription medications should be of particular concern to regulators, especially when minors are the targeted audience.
Case study: Pretty Little Liars
A current example of potentially problematic DTCA to minors occurred in 3 recent episodes of the popular show, Pretty Little Liars, which is aired in both Canada and the United States, and is legally available for viewing online. The three episodes of concern were aired on January 28, 2014, February 4, 2014, and February 11, 2014. In these episodes, one of the main characters is repeatedly featured ingesting a medication for an off-label use. The pills, which are taken by the character, are clearly visible and identifiable in the show (evidence in letter's appendices).
I, and some of my colleagues, submitted this letter to the regulatory agencies in Canada and the United States to address the problematic nature of the visibility of the specific pills in the storyline. We request answers regarding whether the appearance of the same identifiable pills are a result of paid product placement by the manufacturing drug company. If this is, in fact, a case of paid product placement, this is a case of illegal DTCA because the drugs would have been advertised for an off-label indication.
Access the full letter here: http://www.docstoc.com/docs/document-preview.aspx?doc_id=167131286&key=undefined&pass=undefined
We sent this letter to the following regulatory agencies:
- Canadian Radio-television and Telecommunications Commission (CRTC)
- Commissioner for Complaints for Telecommunications Services (CCTS)
- Canada Vigilance Program, Marketed Health Products Directorate (MHPD)
- Regulatory Advertising Section, Marketed Health Products Directorate (MHPD)
- Office of Prescription Drug Promotion, Food and Drug Administration (FDA)
- Consumer & Governmental Affairs Bureau, Federal Communications Commission (FCC)
Please take the time to read this letter and understand the implications that this sort of product placement, whether paid or not, has on the target audience of the show. Increasingly, television shows, including this show, is legally available online. Teenagers are increasingly able to watch television shows online and with privacy. Parents and guardians are less often aware of the content that their kids and teenagers are viewing. Parents, guardians, and all audiences should become critically aware of the content on television shows and not normalize potentially embedded advertisements.
A decade of direct-to-consumer advertising of prescription drugs
Opening the medicine cabinet: First report on health aspects of prescription drugs
Twelve years' experience with direct-to-consumer advertising of prescription drugs in Canada: A cautionary tale
How does direct-to-consumer advertising (DTCA) affect prescribing? A survey in primary care environments with and without legal DTCA
Direct-to-consumer pharmaceutical advertising: Therapeutic or Toxic?
Powerpoint: Direct-to-consumer advertising of prescription drugs
Direct-to-consumer advertising of prescription medications: The evidence says No
Direct-to-consumer advertising and expenditures on prescription drugs: A comparison of experiences in the United States and Canada
Should Canada allow direct-to-consumer advertising of prescription drugs? NO
US FDA: Keeping watch over direct-to-consumer advertising
Electronic direct-to-consumer advertising (eDTCA) of prescription medications unregulated in Canada
Direct to consumer advertising: The affect on the pharmaceutical industry
Search: direct to consumer advertising in different countries
Pharmaceutical research and development: What do we get for all that money?