Direct-to-consumer advertising by fjzhxb


									Direct-to-consumer advertising
Public health implications of US regulatory violations 1997- 2005
Barbara Mintzes
Therapeutics Initiative Centre for Health Services & Policy Research, UBC

Reka Pataky
Centre for Health Services & Policy Research, WRTC, UBC

Bridging Silos – CAHSPR 2008 Conference May 27, 2008, Gatineau, Quebec

What is a medicine?

A pharmaceutical product + information

Approval, safety evaluation, for specified uses Treatment decisions - balance of benefit vs. harm
Milder problem, less effective harm less acceptable

Drug promotion far outweighs independent info

Regulation of drug promotion

Part of post-market surveillance responsibility Little attention, few resources devoted to task Mainly delegated to industry self-regulation In Canada:
Advertising standards Canada Pharmaceutical Advertising Advisory Board Rx&D Code of Conduct Committee

At Health Canada, < 1 dedicated FTE


US FDA direct government regulation
DDMAC ~ 40 employees Differences vs. Canada
Requirement for fair balance of benefit & harm Public health concerns often raised Company must submit ad when campaign starts

‘Untitled’ and ‘warning’ letters posted on web

Since 2002, administrative delay ~ 4-5
months Rapid increase in DTCA volume:

US regulatory violation – exaggerated benefits, no risk information Implied complete symptom relief, cure of IBS with constipation.


“FDA is not aware of any studies in which patients experienced complete relief within 3 days of starting treatment with Zelnorm.” “The ad… fails to clearly communicate the indication and limitations to use… of particular concern because Zelnorm has serious safety concerns that pose a considerable risk to public health and safety.”

US DTCA Regulatory violations
1997 to 2005

US General Accounting Office Report GAO07-54

89 drugs, 25 with repeat violations (n=138) FOI request for drug names Information extracted from regulatory letters
Potential public health impact

Who is targeted, with what condition? What type of violation?

Most frequent indications

Indication Allergy Lipid lowering Impotence HIV/AIDS Osteoporosis Contraception

Drugs with Which drugs? ≥1 violation Yes Yes Yes No Yes No Prevacid, Prilosec Evista, Fosamax Claritin/Claritin D, Zyrtec, Allegra Pravachol, Lipitor, Crestor MUSE, Caverject, Viagra

Acid Reflux/ PPI Yes

Types of regulatory violations

Key violations identified by FDA
(in > 1 letter)


Risks omitted or minimized Overstatement of efficacy Broadening of indications Joint benefit/ risk violation Misleading superiority claim Inadequate patient info provision Minimized role of physician

62 (45%) 22 (16%) 20 (15%) 12 (9%) 10 (7%) 3 (2%) 2 (1%)

A false superiority claim for a cholesterol-lowering drug (rosuvastatin), based on a non-equivalent dose comparison. (March 8, 2005 FDA letter)


Does the drug have serious risks?
Drug subject to regulatory action Drug safety withdrawal Black box warning or withdrawal Among top 15 drugs suspected in reported deaths Among top 15 drugs suspected in non-fatal serious adverse events
* Moore et al. Arch Intern Med 2007; 167: 1753

# violations 3 (2%) 32 (23%) 4 (2%) 11 (8%)

Serious adverse event reports: 1998 to 2005*

Drugs with black box or safety withdrawal and regulatory violations

Risk omission or minimization:
94% with serious risks vs. 71% without, p <.05

No difference in frequency of violations involving exaggerated benefits, unapproved indications or superiority claims.

“…overstates the effectiveness, fails to communicate the limitations of the indication, thereby broadening the indication…and it minimizes the risks associated with the drug. (Feb 18, 2005 FDA warning letter)

Etanercept ranked # 10 in reported deaths (n=1034), 1998-2005 (Moore et al, 2007)

Targeting of men and women

Most advertised drugs targeted both sexes
Men only in 10 (7%); women in 24 (17%) Odds ratio = 2.6 (95% CI 1.2 – 6.1), p<.05

Consistent with overall advertising trends

“…concerning from a public health perspective because it fails to mention the risk of suicidality.” (May, 2005 FDA letter)

Limitations of this analysis

FDA cannot examine all DTCA – a subset of potentially illegal ads Review priorities linked to public health aims Preliminary analysis: images, models, medium also key to targeting

In conclusion

Highlights the importance of information access; FDA letters are posted on the web In surveys of random samples of the US public, 29% to 42% thought only the safest drugs could be advertised to the public Risk-related violations were more frequent among drugs with serious risks Is regulation of drug promotion a public safety concern? Yes, very much so.



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