Electronic letters to:

Commentary:
David M. Gardner, Barbara Mintzes, and Aleck Ostry
Direct-to-consumer prescription drug advertising in Canada: Permission by default?
CMAJ 2003; 169: 425-427 [Full text] [PDF]
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Electronic letters published:

[Read eLetter] Indirect-to-consumer ads, through proxies
Eddie Vos   (29 September 2003)
[Read eLetter] One statement; two different conclusions
Nigel S B Rawson   (10 September 2003)

Indirect-to-consumer ads, through proxies 29 September 2003
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Eddie Vos
www.health-heart.org

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Re: Indirect-to-consumer ads, through proxies

vos{at}health-heart.org Eddie Vos

The fourth category of drug advertising, not mentioned by Gardner et al (1), is INdirect-to-consumer ads (an expanded version of  "help-seeking" category 3 advertising) in which the drug company pays third parties to create a drug need without the sponsor's name even appearing.

The drug industry has to give adequate prescribing data in the medical journal ads.  For example, Pfizer's current Canadian Lipitor ad states: "The effects of atorvastatin-induced changes in lipoprotein levels, including reduction of serum cholesterol on cardiovascular morbidity or total mortality have not been established."

On the other hand, in three September, 2003, issues of the Canadian edition of Time Magazine is an ad "Sponsored by one of Canada's research based pharmaceutical companies" [Pfizer].  It has a text by the "Canadian Lipid Nurse Network" with a stark feet-in-morgue picture (2) suggesting that getting a cholesterol test may reduce one's chance of dying.  "Which would you rather have, a cholesterol test or a final exam?"  Apart from the fact that "lipid nurses" cannot prescribe statins, this is a reminder of the dark old days when milk-nurses promoted formula to third world mothers.  The original owner of the Lipid Nurse Network website was the sponsoring drug company and in the earlier ads the Pfizer name appeared but it no longer does.

The latest and largest atorvastatin [Lipitor] trial was stopped at three years at a zero mortality difference, with placebo at 1.7 years doing marginally better and with the mortality curves again touching at 3 years, the official end of the study for the bulk of the participants.  The above link also gives the mortality curve for ALLHAT, "the second largest long-term statin trial".  While one can argue that statins might have a cardio-benefit in some high-risk patients (something not found in ALLHAT), there is no debate that statins would reduce all-cause mortality.  In fact, the ALLHAT website (3) states: ".. trials demonstrating a reduction in CHD [coronary heart disease] from cholesterol lowering have not [sic] demonstrated a net reduction in mortality."

Allowing drug a company to finance advertising campaigns through third parties that frighten the public in order to get medical tests for which there is no scientific or drug-regulating body support should stop, and regulators should put an end to this practice.  This practice is even more deplorable since the overall picture of cholesterol-lowering trials, from omega-6 polyunsaturated oils and cholesterol intake reductions (4) to the statins, does not support mortality benefits from cholesterol lowering in most high-risk groups (3)

Eddie Vos, eng., Sutton (Qc)  E-mail: vos@health-heart.org
Colin Rose, M.D., McGill University, Montreal (Qc)

(1) Gardner DM, Mitzes B, Ostry A, Direct-to-consumer prescription drug advertising in Canada: Permission by
Default? CMAJ. Sept 2, 2003: 169 (5): 425-7.

(2) Photo page:  http://www.health-heart.org/WouldYouRather.jpg 

(3) ALLHAT website  http://allhat.sph.uth.tmc.edu/study/study.cfm  [accessed, Sept. 25, 2003]

(4) Hooper L, Summerbell et al. Dietary fat intake and prevention of cardiovascular disease: systematic review. BMJ
2001; 322: 757-763 [full text]

Conflict of Interest:

None declared
One statement; two different conclusions 10 September 2003
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Nigel S B Rawson
Center for Health Care Policy and Evaluation

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Re: One statement; two different conclusions

nigel_rawson{at}uhc.com Nigel S B Rawson

Gardner et al. argue that, by stimulating early uptake of new drugs, direct-to-consumer advertising (DTCA) magnifies the dangers of their use. In fact, the opposite is true. Rare adverse drug reactions (ADRs) are likely to be identified after marketing only when a sufficiently large cohort of patients has been exposed. Rapid cohort accumulation should lead to earlier ADR identification, reducing the overall number of patients experiencing it. A slow buildup of patient use over a long period does not prevent ADR occurrence but may inhibit its recognition.

Gardner et al. also state “20% of new drugs eventually receive new black box warnings on the product monograph after marketing or are withdrawn from the market because of serious safety concerns.” In the work cited for this statement (1), 20% is a probability estimate, whereas the actual proportion of drugs that received a new black box warning or were withdrawn was only 8.2% (just 2.9% were withdrawn).

In 1992-2001, the rate of drugs discontinued for safety reasons was 3.6% in the US and 2.0% in Canada (2). When a serious ADR was identified soon after US approval, the drug was still under review in Canada’s slower approval process, leading to the lower rate. However, the cost of this limited drug safety benefit is delayed access to medications. Patients with serious conditions for which current therapy is ineffective or non- existent are more likely to be concerned by the slower access to new drugs in Canada than any safety issue associated with DTCA.

1) Lasser KE, Allen PD, Woolhandler SJ, Himmelstein DU, Wolfe SM, Bor DH. Timing of new black box warnings and withdrawals for prescription medications. JAMA 2002; 287: 2215-20. 2) Rawson NSB, Kaitin KI. Canadian and US drug approval times and safety considerations. Ann Pharmacother 2003; 37: (in press).

Conflict of Interest:

None declared