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Letter to the Editor

Editor, – The editorial by Sidney Wolfe (Aust Prescr 2012;35:138-9) suggested that patients should not take any pharmaceutical drugs that have been released until they have been taken by other patients for seven years. By that time, half of the black box warnings or market withdrawals that would ultimately occur for a drug over its lifespan would have already happened.

The logical corollary of this, if it was adopted by all patients, is that the seven-year rule would immediately become an infinite year rule as no patients would be taking any new drugs. Clearly, widespread adoption of this recommendation would have profound effects on achieving any improvement in disease states, let alone the capacity of pharmaceutical companies to continue to exist. The editorial reports that even 25 years is not long enough to exclude the possibility of a new black box warning or market withdrawal.

Perhaps it would be better to outline to patients that changes to medication recommendations can occur and half of these occur within the first seven years and leave it to a harm–benefit discussion between the patient and their prescriber about whether the new medication should be trialled or not.

I do not think that blanket ban approaches are particularly helpful or necessarily balanced.

Marc Russo
Pain medicine physician and specialist

Author's comments

Sidney Wolfe, the author of the editorial, comments:

Marc Russo’s assertions that the seven-year rule, if adopted by all patients, would result in a situation in which ‘no patients would be taking any new drugs’ and would ‘have profound effects on achieving any improvement in disease state’ are both incorrect. The editorial clearly states that the rule would not apply to that small proportion of new drugs that represent therapeutic breakthroughs. Patients are not discouraged from using breakthrough drugs, which are defined as offering ‘a documented therapeutic advantage over older, proven drugs’. Furthermore, if more patients and their healthcare providers adhered to the rule, there might actually be more incentives for drug companies to develop true breakthrough drugs to improve treatment of diseases, rather than developing a tenth ACE inhibitor, an eighth angiotensin II receptor antagonist or a seventh statin.

Beyond the absence of a documented therapeutic advantage of many new drugs is the increased likelihood of harm from a drug that is statistically much more likely than established, time-tested drugs to have a new risk discovered after marketing – one serious enough to trigger a new black box warning or even market withdrawal.

Russo’s proposed alternative to the not ‘necessarily balanced’ seven-year rule is to ‘leave it to a harm-benefit discussion between the patient and their prescriber’ to see if the new medication warrants being used. This risks a decision that will likely be tilted toward use because of massively higher promotion of these new drugs to doctors compared with older ones. This decision is therefore more likely to be necessarily unbalanced.

Further Reading

Weekes L. The seven-year itch. The MedicineWise CEO. 2012 Oct 22. [cited 2013 Feb 11]