Healthy Skepticism International News

Givisiez Rocmaline (arginine, malic acid)

October 1999

Vol 17 Issue 10/11 The promotion of Rocmaline® (arginine, malic acid) by Frilab in French-speaking Africa for "symptomatic treatment of asthenia in adults and children "

This edition is late

We apologise for being behind schedule with the production of this edition.

We have been busy with many projects. These include producing teaching materials for PHARMAC (the New Zealand drug purchasing agency) and for the Australian National Prescribing Service. We have also produced reports on direct-to-consumer promotion of pharmaceuticals for the Pharmacy Guild of Australia and for PHARMAC.

Our expenses far exceed our income from subscriptions. Consequently we need such projects to provide income to enable us to keep MaLAM going.

The promotion of Rocmaline® (arginine, malic acid) by Frilab in French-speaking Africa for “symptomatic treatment of asthenia in adults and children “

The topic for our MaLAM letter was chosen by our French division, PIMED in response to a request from a pharmacist in Benin. PIMED also produced the first draft. The Medline search and final editing were performed in Adelaide.

December 1999

President
FRILAB, S.A
Givisiez
CH 1701 Friburg
Switzerland

Re: The promotion of Rocmaline® (arginine, malic acid) in French-speaking Africa

Dear Sir,

A pharmacist in Benin has asked MaLAM to write to you about the promotion of Rocmaline® in his country. He sent us a copy of the advertisement that FRILAB uses to promote this product to health professionals in Benin. According to this document, Rocmaline® oral solution is indicated for:

“symptomatic treatment of asthenia in adults and children “

Comparison of your claims with initial conclusions based on the scientific literature available to MaLAM [1], summarised below, raises some questions. This letter is intended to give you the opportunity to express your point of view so that we can assess whether your claims assist appropriate therapy. We hope that you will either provide evidence to support your claims or reconsider the promotion of Rocmaline®. We hope that dialogue can lead to improvements in drug promotion to the benefit of the public, health professionals and your company.[2]

Initial conclusions from the scientific literature

We did not find any evidence of efficacy for Rocmaline ® (arginine, malic acid) for the indications mentioned above.

We used the US National Library of Medicine’s Internet Grateful Med to perform a Medline search for the title words “aginine” and “malic acid”. We found the following 5 articles all published more than 20 years ago.

Falk M, et al. [Mass analytic determination of arginine hydrochloride in the presence of malic acid with the use of ion exchangers]. Pharmazie. 1978 Sep;33(9):610-1. German. No abstract available.

Gucalova OY, et al. [Effect of mixture of malic acid and arginine on uptake of ammonia in muscles]. SOURCE: Cas Lek Cesk. 1975 Aug 29;114(34-35):1060-2. Slovak. No abstract available.

Bichler KH, et al. [Iatrogenic alkalosis caused by malic acid-arginine infusions]. Bruns Beitr Klin Chir. 1970 Nov;218(4):326-31. German. No abstract available.

Gurakar M, et al. [Investigations of the clinical and biological effects of combined arginine and malic acid in provoked hyperammonemia]. Turk Tip Cemiy Mecm. 1966 Mar;32(3):173-81. Turkish. No abstract available.

Gadot J [The association of malic acid-arginine in pediatric therapeutics]. Med Infant (Paris). 1965 Nov;72(9):667-9. French. No abstract available.

Argenine is an amino acid. It is essential for infant growth, and can be used as a dietary supplement but is usually best obtained in food. The only information we have been able to find about the therapeutic use of argenine concerns the injectable formula for reducing hyperammonaemia.

We found no evidence to support the use of the malic acid component of the combination for the treatment of asthenia.

We found no evidence to substantiate the use of Rocmaline® in the indications proposed by other manufacturers (“presumed hepatic disorders” see Vidal 1999).

Our current conclusions

To our knowledge, the effect of arginine and malic acid in the treatment of asthenia in adults and children has never been demonstrated in any adequate clinical trial. Furthermore in Africa, the target of the advertisement for Rocmaline®, asthenia results most often from malnutrition caused by lack of financial resources. Treating children with Rocmaline® may actually worsen their nutritional status by diverting the financial resources of malnourished children’s parents towards drugs instead of food.

However, you may have evidence to substantiate your promotional claims. We request that you provide us with a copy of your best evidence to justify the promotion of Rocmaline® for the treatment of asthenia in adults and infants or urgently reconsider your promotion.

Yours sincerely,

Dr Joel Lexchin MD, CCFP (EM), DABEM
Secretary, MaLAM Inc
www.camtech.net.au/malam

December 1999

President
FRILAB, S.A.
Givisiez
CH 1701 Friburg
Switzerland

Dear Sir,

I have read the MaLAM International edition about the promotion of Rocmaline® by your company in French-speaking Africa.

(Please tick where appropriate)

I am a: doctor

pharmacist

nurse

………………………

and would appreciate receiving a personal copy of your reply. q