[e-drug] Clinical equivalence of generic and brand-name CVS drugs -JAMA (2)

e-drug
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E-DRUG: Clinical equivalence of generic and brand-name CVS drugs -JAMA (2)
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Dear E-Druggers,
  
According to an article recently published in JAMA, the systematic review of several clinical trials shows that generic and innovator medicines are
therapeutically equivalent (Ref. A.S. Kesselheim et al., Clinical Equivalence of Generic and Brand-Name Drugs Used in Cardiovascular Disease. A Systematic Review and Meta-analysis. JAMA, December 3, 2008-Vol 300, No. 21).
  
However, the conclusions of this review refer to the criteria used by the US FDA to approve generic medicines ("our results suggest that it is reasonable for physicians and patients to rely on FDA bioequivalence rating as a proxy for clinical equivalence among a number of important cardiovascular drugs, even in higher-risk contexts such as the NTI drug Warfarin"). We can imagine that similar results would be obtained taking into account the criteria used in other countries with stringent Drug Regulatory Authorities (EU, Japan, Australia etc.), which require and verify the proof of bio-equivalence for substances and formulations that need it.

Nonetheless, according to WHO (Drug Information Vol. 22, No. 3, 2008), more
than two thirds of the world population live in countries whose systems to
assure the quality, safety and efficacy of medicines are inadequate or
insufficient. Since the majority of generic medicines marketed in developing countries are not registered in strictly-regulated countries, and since manufacturers tend to adapt the quality standards according to the requirements enforced in the countries of the end-users (ref. J.M. Caudron et al, Substandard medicines in resource-poor settings: a problem that can no longer be ignored. Tropical Medicine and International Health. 2008; 13:8,1062-1072), the results of this study cannot, unfortunately, be
generalised from the US context to the context of developing countries.
  
Jacques Pinel, pharmacist
Raffaella Ravinetto, pharmacist, Institut of Tropical Medicine, Antwerp
Daniel Vandenbergh, pharmacist
Sophie Marie Scouflaire-Mallet, pharmacist
rravinetto@itg.be

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E-DRUG: Clinical equivalence of generic and brand-name CVS drugs -JAMA (3)
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I appreciate your point about not automatically applying US research to
quite different contexts. But the primary point of the study was that
generics for cardiovascular conditions are clinically equivalent to branded
products, and yet journal editorials are inappropriately biased against
generics. Why are the editorials more negative than the evidence supports?

The fact that national drug regulatory agencies need to be improved in many
countries doesn't undermine this finding. In the countries you speak of,
what assurance do we have about the quality of non-generic branded
medicines? In fact, more expensive branded products might be more
susceptible to counterfeiting than less expensive generics.

Kevin Outterson
Boston University School of Law
765 Commonwealth Ave., Boston MA 02215
617 353 3103
http://ssrn.com/author=340746
mko@bu.edu