Complaint Letter to Minister Tony Clement Regarding DTCA of Celebrex

March 14, 2006

Honourable Tony Clement,
Minister of Health
Brooke Claxton Building
Tunney's Pasture
AL: 0916A
Ottawa, ON
K1A 0K9

Honourable Minister Clement,

As representatives of a national women's health organization, Women and Health Protection, we are writing to raise concerns about the risks to public health of an advertisement for a prescription drug, Celebrex (celecoxib), that is currently airing on Canadian television. We ask you to take immediate regulatory action to stop this advertising campaign and to impose sanctions on the sponsor, Pfizer, to prevent future violations. The Celebrex advertisement is currently running in both English and French, on CBC television, Radio-Canada, CTV, and possibly other networks. We attach a copy of the ad on CD to the hard copy of this letter.

Health Canada has sent out a safety advisory to Canadian physicians and the public because of evidence of increased cardiovascular risks with Celebrex (celecoxib). Similarly both the European Medicines Evaluation Agency and the U.S. Food & Drug Administrations have sent out advisories about cardiovascular risks, and recommended prescribing only for the shortest possible time at the lowest effective dose.¹

Cardiovascular disease is a leading cause of death and disability in Canada, including in older women, who appear to be the primary target audience of the advertisement that is currently being aired. If this advertisement is successful in stimulating sales, it will lead to higher levels of exposure to Celebrex (celecoxib) in older women. Based on the clinical trial evidence, this increased exposure is likely to lead to extra heart attacks and strokes.² ³

Celecoxib, like other "non-steroidal anti-inflammatory" analgesics, also causes serious gastro-intestinal hemorrhage, impairment of kidney function, worsening of congestive heart failure, and elevation of blood pressure, especially in elderly patients already at risk from multi-organ health problems.

This advertisement is illegal under Canada's Food & Drugs Act. It is clearly an advertisement under the definition in the Act: “any representation by any means whatsoever for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic or device.” It advertises a drug that is only available by prescription in Canada [Schedule F] and it is not a price advertisement, the sole exception to the prohibition against prescription drug advertising to the public permitted under the Act. Clause C.01.044 states that, “Where a person advertises to the general public a Schedule F Drug, the person shall not make any representation other than with respect to the brand name, proper name, common name, price and quantity of the drug.” The advertisement includes many other representations, including the models that are speaking about the drug, the activities they are carrying out, the impression of well-being, and the suggestion to speak to your doctor about this product. It contravenes both the spirit of clause C.01.044, as it is not a price advertisement and could never be mistaken for one, and the stated restrictions in the clause, as it includes representations other than name, price and quantity.

The advertisement further violates section 9 (1) of the Food & Drugs Act as it is “…likely to create an erroneous impression regarding its [the drug's] composition, merit or safety.” There is nothing in the advertisement indicating that this is a product for which there are serious safety concerns. Additionally, the impression provided about the product's merits is erroneous in that there is no additional benefit as compared with alternative, less expensive arthritis treatments. Celebrex (celecoxib) has not been shown to be any more effective against arthritis symptoms than other non-steroidal anti-inflammatory drugs. ⁴ ⁵ Yet the glowing, smiling models and the images of swimming and other activities suggest effectiveness beyond what was previously available, i.e. an effectiveness advantage, which has not been demonstrated by scientific evidence.

Beyond the concern of harm to individual members of the public, inadequate regulation to prevent misleading and illegal prescription drug advertising is of concern to provincial governments, given that they must bear the cost consequences of extra physician visits and hospitalizations, and pay for extra prescriptions for more expensive and less cost-effective prescription drugs. We are therefore sending copies of this complaint to provincial drug plan managers and health ministers.

As you are no doubt aware, Pfizer ran an intensive direct-to-consumer advertising campaign for Celebrex (celecoxib) in the U.S. just after Merck's global withdrawal of Vioxx (rofecoxib) in September 2004. There were already indications that the extra cardiovascular risks were a class effect shared by all Cox-2 inhibitors, including Celebrex (celecoxib). ⁶ In December 2004, following the release of the results of an additional trial indicating increased cardiac risks with celecoxib, the U.S. Food & Drug Administration asked Pfizer to stop all direct-to-consumer advertising for this product, and Pfizer complied.⁷

Although this regulatory action occurred in another jurisdiction, Canada's laws similarly allow the federal health department to take regulatory action because of pressing public health concerns. Ironically, although direct-to-consumer advertising is legal in the U.S. and illegal in Canada, this advertisement – allowed thus far to run in Canada – would be illegal in the U.S. for an additional reason. In the U.S. Celebrex has a black box warning on its label, warning prescribers that the drug is associated with serious risks. ⁸ The ad running in Canada is classified as a reminder advertisement under U.S. pharmaceutical advertising regulations. Reminder advertisements are not allowed to run for drugs with black box warnings. Additionally, the major pharmaceutical companies, including Pfizer, came to a voluntary agreement to no longer run reminder advertisements on U.S. television in July 2005, following the widespread safety concerns raised about direct-to-consumer advertising following the withdrawal of Vioxx (rofecoxib).

We ask your department to take immediate regulatory action to have this advertisement pulled from the airwaves and to impose sanctions to prevent future similar violations. Pfizer should also be required to finance a corrective advertising campaign within the same media and at the same intensity level as this campaign.

We would also like answers to the following questions:

What immediate actions is your department taking to stop this advertising campaign and to ensure corrective measures to the Canadian public?
What sanctions is your department planning to impose?
What steps are you taking to investigate this campaign?
What is the timeline for the investigation?
What will be done to avoid further public exposure to misleading messages from this ad campaign while it is under investigation?
What decisions have you made and conveyed to the company?

Thank you in advance for your assistance. Protecting the public from misinformation on health and medical treatments – particularly misinformation that takes advantage of the public's fear of death and disability – is a key regulatory function with important implications for public health.

If you have any questions or require further clarification or additional information, do not hesitate to get in touch with us.

Sincerely,

Anne Rochon Ford

on behalf of the Steering Committee of Women and Health Protection:
Dr. Ken Bassett, University of British Columbia
Ms Sharon Batt, Dalhousie University
Ms. Madeline Boscoe, Women's Health Clinic, Winnipeg
Dr. Joel Lexchin, York University
Dr. Abby Lippman, Canadian Women's Health Network
Ms Karen Seabrooke, Women's Health Interaction
Dr. Barbara Mintzes, University of British Columbia
Ms. Laura Shea, Breast Cancer Action Montreal

and affiliated members of Women and Health Protection:
Linda Bayers, PhD
Dr. Warren Bell
Ms. Kyla Bertschi, Regional Clinical Pharmacy Specialist
Ms. Angela Bischoff, Greenspiration
Hélène Brassard, PhD
Mr. Alan Cassels, University of Victoria, Project Leader, Media Doctor Canada
Ms. Janine O'Leary Cobb, Breast Cancer Action Montreal
Ms. Kathleen Connors, Chairperson, Canadian Health Coalition
Ms. Janet Currie, Board Member, PharmaWatch
Mr. Paul Filiatrault BSc(Pharm), RPh.,
Ms. Colleen Fuller, PharmaWatch
Dr. Peggy J. Kleinplatz, University of Ottawa
Ms. Carol Kushner, Health Policy Analyst
Dr Peter R Mansfield, Healthy Skepticism, Inc.
Ms. Barbara Martinez
Dr. Nancy F Olivieri, University of Toronto
Dr. Thomas L. Perry, University of British Columbia
Ms. Elsie Petch, MHSc
Dr. Michael Rachlis
Professor H.G. Rosenberg, York University
Ms. Ann Silversides
Dr. Aaron Tejani, BSc(Pharm), Pharm.D
Professor Mary E. Wiktorowicz, York University
Dr. James M. Wright, University of British Columbia
Mr. Terence Young, Drug Safety Canada
cc:

Ms Anne Szukte-Fournier, Advertising Coordinator, Marketed Health Products Directorate, Health Canada
Mr. Stephen Fletcher, MP, Parliamentary Assistant to the Minister of Health
Mr. Neil Yeates, ADM, Health Products and Food Branch
Mr. Ray Chepesiuk, Pharmaceutical Advertising Advisory Board
Ms. Joanne Lacroix, Acting Director, Bureau of Women's Health and Gender Analysis
Mr. Robert rabinovitch, President and CEO, CBC
Mr. Ken Dryden, Liberal Health Critic
Ms. Penny Priddy, NDP Health Critic
Mme. Christiane Gagnon, Bloc Québecois Health Critic
Provincial health ministers
Provincial drug plan managers
André Picard, Globe & Mail
Mr. Charlie Smith, Georgia Straight

Footnotes

[1] EU's EMEA recommends the suspension of Bextra and adds more warnings to other COX-2s. Scrip 2005; 3067: 3; FDA reins in use of coxibs. Scrip 2005;3017:24

[2] Solomon SD, McMurray JJ, Pfeffer MA et al. Cardiovascular risk associated with celecoxib in a clinical trial for colorectal adenoma prevention. N Engl J Med 2005; 352:1071-80

[3] Pfizer. A double-blind randomized placebo-controlled comparative study of celecoxib (SC-58635) for the inhibition of progression of Alzheimer's disease, protocol IQ5-97-02-001. Accessed March 2006, at http://www.clinicalstudyresults.org/documents/company-study_76_0.pdf

[4] Taking stock of coxibs. Drug & Therapeutics Bulletin 2005; 43(1):1-6

[5] Lee C, Hunsche E, Balshaw R et al. Need for common internal controls when assessing the relative efficacy of pharmacologic agents using a meta-analytic approach: Case study of cyclooxygenase 2-selective inhibitors for the treatment of osteoarthritis. Arthritis Care & Research 2005; 53(4): 510-518

[6] Wright JM. The double-edged sword of COX-2 selective NSAIDs. CMAJ 2002; 167: 1131-1137

[7] FDA exposes problems with Celebrex and Bextra adverts even before DTC (direct-to-consumer) halt. Scrip January 14, 2005. www.scrippharma.com

[8] US FDA puts black box on all NSAIDS (non-steroidal anti-inflammatories). Scrip 2005; 3065:28

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