DTC Ads Should Be Better, Not Banned, In Wake Of Vioxx, Ex-FDAer Pitts Says

The response to the Vioxx withdrawal offers further evidence of the need for FDA and manufacturers to modify the "brief summary" requirement in direct-to-consumer ads, former Associate Commissioner for External Relations Peter Pitts said during a Nov. 10 Drug & Device Dialogue audio conference sponsored by F-D-C Reports and Polidais LLC.

"Direct-to-consumer advertising needs to be reinforced and made better, not to be done away with," Pitts declared. "This is a clarion call for clear and more concise patient information."

Pitts noted that many patients were surprised to learn of Vioxx' (rofecoxib) risks when Merck pulled the drug Sept. 30, even though the cardiovascular risk information was included in labeling and disclosed in advertising.

"Had people paid closer attention to" the risks, "they might not have been so shocked when the drug manifested certain adverse events," Pitts said. "If anything comes out of the Vioxx situation that can be defined in any way as positive, I would say it's the debate that the public needs to accept that drugs have risks and how to best communicate that," he said.

"The brief summary needs to be done better," Pitts said. "The risk information needs to be more clearly communicated."

Pitts, who is now senior VP-health affairs at public relations firm Manning, Selvage & Lee, worked on FDA's DTC advertising guidances released early this year. One of the draft guidances outlined possible alternatives to the brief summary (¹ (Also see "Risk Information “Window” Proposed By FDA For DTC Print Ads" - Pink Sheet, 9 Feb, 2004.), p. 4).

FDA's Division of Drug Marketing, Advertising & Communications is in the process of conducting three studies that will assist in the development of final guidances (² (Also see "FDA Research Protocols On DTC Brief Summary Info To Be Finalized In Fall" - Pink Sheet, 20 Sep, 2004.), p. 25).

[Editor's note: An archived webcast of the Nov. 10 Drug & Device Dialogue is available from F-D-C Reports. For more information, visit our website, ³ www.DrugDeviceDialogue.com , or call 1-800-332-2181.]

The Vioxx withdrawal has fueled criticism of DTC ads and led to speculation that legislative proposals to limit the practice may be revived in 2005 (⁴ (Also see "Vioxx Withdrawal Fuels Criticism Of DTC; Liability Exposure May Be Test" - Pink Sheet, 11 Oct, 2004.), p. 4).

"A lot of people, especially a lot of people who have run or hold elective office, are using the Vioxx situation as a whipping child for direct-to-consumer advertising," Pitts said.

Pitts suggested that the withdrawal instead underscores the need to use direct-to-consumer promotions to communicate drugs' risks as well as their benefits.

"If people understand that drugs have benefits, they should also understand they also have risks. That may sound logical, but I know that according to FDA's own research into direct-to-consumer advertising, that has not played out. The benefits are understood, but the risks are somewhat buried in plain sight," he said.

Pitts also argued that another issue likely to receive legislative attention - public clinical trial data registries - will do nothing to help physicians communicate drug risks to patients (⁵ (Also see "HHS Registry Of Clinical Trials Proposed By AMA To Limit Publication Bias" - Pink Sheet, 21 Jun, 2004.), p. 6).

"When a drug manifests adverse events that require either a change in labeling or a recall, people are shocked and assume that something must be wrong with the system. I think nowhere is this more evident than with some of our current elected officials," Pitts said.

A congressional hearing will be held Nov. 18 to discuss the Vioxx withdrawal (see ⁶ (Also see "Senate Vioxx Hearing Looks Like Tough Going For Merck, Pfizer" - Pink Sheet, 15 Nov, 2004.)). FDA will also hold an advisory committee in early 2005 to discuss the safety of COX-2s and NSAIDs.

Pitts also commented on ads that sponsors of competing agents have aired following the Vioxx withdrawal. "The ads that I saw certainly were not misleading," Pitts said. "The ads that I did see basically were showing options and some were doing it more aggressively than others," he said.

Pfizer, Abbott/BI and several over-the-counter pain medication manufacturers tried to capture Merck's share of the COX-2/NSAID market by launching DTC ads shortly after the withdrawal (⁷ (Also see "Celebrex Long-Term Safety Monitoring Results Reassure FDA" - Pink Sheet, 8 Nov, 2004.), p. 14).