Healthy Skepticism Library item: 13359
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Publication type: news
BMS decision to stop producing a paediatric form of efavirenz angers associations
APM Health Europe 2008 Mar 27
http://www.apmhealtheurope.com/home.php
Full text:
PARIS, March 27 (APM) – The French AIDS group federation, TRT-5, is protesting against the planned cessation of production of a formulation of the Bristol Myers Squibb anti-HIV drug Sustiva (efavirenz) for paediatric use, according to a press statement released on Wednesday.
This is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that is marketed in several different forms: a 600 mg tablet and 50 mg, 100 mg and 200 mg capsules and a liquid formulation. The liquid form and the 50 mg and 100 mg capsules are the main formulations used for children.
In its press statement, TRT-5, that was unavailable for comment on Thursday, indicates that BMS is about to stop marketing the 100 mg capsules, “whereas the range of antiretrovirals available to treat children is particularly limited.”
According to TRT-5 the other formulations are less appropriate, either because the dose is too high (600 mg tablet, 200 mg capsule), or because of unpalatable taste and lower bioavailability (liquid form), or because it will be necessary to double the number of capsules (using the 50 mg capsules).
TRT-5 points out that these two forms entail constraints (as the liquid form of the drug is unpalatable it is difficult to get children to take it and using 50 mg capsules means the children have to swallow large numbers of capsules) that will affect treatment observance. The statement says observance “is an essential factor for treatment efficacy.”
The various AIDS associations consider that this approach, on the part of BMS, is contrary to EC regulation No. 1901/2006 on medicinal products for paediatric use that came into force in January 2007. The Regulation is in favour of encouraging the development of paediatric medicines.
Contacted by APM on Thursday, a BMS spokesman acknowledged that the pharma company had not communicated correctly on the issue, in particular where associations were concerned. He expressed regret at this lack of foresight.
The decision to stop production of the 100 mg capsules was taken “last year within the framework of rationalising the companys anti-HIV products.” The spokesman said that various paediatricians had been contacted at the time, and French paediatricians among them, to ensure that this would not raise problems.
The spokesman mentioned the low volume of prescriptions for the 100 mg capsules in France. According to him, in 2007, just 800 boxes of the 100 mg capsules were sold, with a monthly average of 21 boxes delivered in hospital and 47 boxes in the community.
TRT-5 agrees that sales of this dosage are low in France but argues that “BMS seems not to take into account the importance of this presentation [of the drug] in developing countries” where the product is marketed under the name Stocrin by Merck & Co. Furthermore, TRT-5 argues that “the company expressly ignores the requirements of other European countries.”
For his part, the BMS spokesman said the company had “not encountered any problems in other European countries.”
As for the other paediatric formulations (syrup and 50 mg capsule), the spokesman said, “We dont claim these are ideal, but there is no medical problem;” he pointed out that in 2007 BMS had ceased production of 15 mg Zerit (stavudine) and that this had not raised any opposition.
DISCUSSIONS WITH AFSSAPS
Whereas it was planned that marketing of 100 mg capsules of Sustiva would cease in spring 2008, the French health products safety agency (Afssaps) has asked BMS to delay this until the end of the year.
Contacted by APM, Afssaps said, “at least until the end of the year” and also expressed criticism of the BMS project to cease this production.
The agency said, “This situation is worrying, especially as the other forms are not particularly well suited to children”; it raised the same issues as TRT-5 over the number of 50 mg capsules to be taken and the unpleasant taste of the syrup.
Afssaps concluded by saying that discussions were continuing in order to “solve the problem.”
In its press statement, TRT-5, points out that the Indian generics manufacturer Cipla manufactures a generic form of the 100 mg capsule and goes as far as suggesting France could issue a compulsory licence [for importing the generic product to France], a mechanism set up by the World Trade Organization (WTO) to facilitate access to generic drugs by less developed countries.
