The Advertising Standards Authority has rejected a complaint that
pharmaceutical giant Bayer has been trying to disparage generic drugs
and create doubts about their safety.
It said a statement in Bayer advertorial that there were "questions"
about nifedipine's bioequivalence were factual and in the public
interest.
Nifedipine, sold under the brand names Adalat, Nifedical, and
Procardia, is used for treating chest pain resulting from coronary
artery spasm.
The complaint was lodged by the National Association of
Pharmaceutical Manufacturers (NAPM) over an article in the March 2008
edition of the Medical Chronicle.
The advertorial said generic drugs were supposed to demonstrate
bioequivalence with their brand name counterparts, and health care
professionals therefore assumed that these products were
interchangeable.
It said new studies however raised questions about the
bioequivalence of generic nifedipine products, and that at least two
generics tested were not able to prove bioequivalence.
Bioequivalence means that before a generic drug can be sold, the
manufacturer must prove that it has the same strength as the brand name
medication, and affects people the same way within the same time frame.
If a generic passes these tests, it is said to be bioequivalent to
the original brand name drug.
The NAPM complained Bayer had misrepresented facts and that the
"questions" did not apply to the South African market, as the studies
related to testing in Europe on European products, which were neither
registered nor marketed in South Africa.
In response, Bayer submitted an opinion from Prof Brian Rayner of
the University of Cape Town's department of medicine, who said there
was no record of anything published in the medical literature in South
Africa on nifedipine.
"In the absence of local information we have to use information
published elsewhere," he wrote.
"These papers were both published in prestigious, peer-reviewed
international journals."
The advertorial, he said, was neither dishonest nor misleading.
The ASA said it was satisfied Rayner's comments adequately supported
the claims made in the advertorial.