Refering to
"SIDE EFFECTS: FREEDOM OF INFORMATION AND THE COMMUNICATION OF DOUBT"
from Andrew Herxheimer
Dear Andrew, Thank you for allowing us to comment on your article draft. Here
are a few comments or suggestions which are details compared to the good points
I found in your draft.
1. Is the article only convincing those who are already convinced ? To
reinforce your message on the communication of doubt I suggest that you mention
the rationale behind protecting pharmaceutical industry. Is there any example
in countries (USA, Australia, Sweden), with data on adverse drug reactions (ADR)
directly available to the public, where this had irrational consequences on
sales or where this information has been misused on purpose to spoil a market?
In general, I think that all positive and negative consequences in these
countries would be interesting elements.
2. The particular point of cotrimoxazole has already been raised by Anne
Holbrook. I would add to it a developing country perspective. The case of
sulfamethoxazole in cotrimoxazole is for me less an example of "difficulties
created by lack of openess" than an example of difference of decision in front
of a doubt. The doubt, here, is on the estimated additional risk of
sulfamethoxazole combined with trimetoprim compared to trimetoprim alone. From
studies it appears to be low but cannot be zero. With the same data on side
effects, UK authorities want to restrict its use, Canada does not because of
cost and compared risk to other options, and WHO Acute Respiratory Infections
programme is promoting its use in developing countries. They might all be
wright because it is a question of evaluation of the expected benefit depending
also on epidemiological information and socioeconomic situation. Who would now
oppose that cotrimoxazole is one of the best drugs, considering cost, compliance
and efficacy, to treat one of the most killing diseases in developing
countries: pneumonia in children ? In many other developed countries, e.g.,
France, the battle against sulfamethoxazole would be the wrong one: I feel that
reducing the over-prescription of all antibiotics would certainly reduce to a
larger extent the number of adverse reaction to sulfamethoxazole than would the
recommendation of prescribing trimetoprim only. Doubt implies differences in
interpretation (as you describe it for the 3rd generation progestagens).
3. Openness and freedom of information is most likely to be a safeguard against
bad practice. This can be illustrated by a case of bad practice in Cameroon
concerning glafenine, which you mention. In 1992 glafenine was banned in France
and thereafter automatically banned in many African French-speaking countries
including Cameroon on the 12/2/92. Notification had been made to the 10
provincial public health authorities but no other public statement of the
decision was made. Theoritically, It should have been published in the 'Journal
Officiel' but the journal was published very irregularly not even yearly. The
Cameroon Tribune, the state owned daily newspaper through which many laws are
made public did not report the decision or at least it went unnoticed. In May
1992, the director of one of the three main drug importers showed me the
figures of importation of glafenine. You couldn't notice any effect of the
decision and he was not expecting any in the near future. The Prescriber's
Bulletin, the Cameroonian independent drug bulletin that you know, published the
information in its promotional first issue which was distributed to all
Cameroonian prescribers and pharmacists. The sales dropped therafter mainly
because pharmacies did not dare to stock the drug any longer. Roussel
representatives verbally assaulted the Prescriber's Bulletin promoters in the
corridor of the 1993 Yaounde National Medical Congress, claiming that only they
had the right to release the news.
In this case, the Cameroonian drug authority had accepted to release to the
bulletin an information usually kept within the administrative path. In
Cameroon, as in many developing countries, the bottleneck is the enforcement of
the regulations, mainly but not only, because of lack of means. And obviously
some drug companies bid on this to continue their business.
Making free the access to information on decisions concerning drugs allows other
actors, professionals or consumers, to take part in the debate. It would
unavoidedly modify the comfortable balance between drug authorities, government
industry authorities and drug companies, but is there any reason to fear that it
would be for the worse?
This last point might be out of subject.
Regards, Jerome