571 would rather explain the casereported by Garavelli and Corti (lot. cit.) as involving relapsesof P. z&x malaria, in spite of primaquine treatment. Relapsesof P. &ax in patients who have received standard primaquine treatment are well known in several countries, including South America (Rombo, L., et al., 1987: Tropical Medicine and Parasitology, 38, 49-50; Arias, R. A. E. & Corredor, A., 1989: Tropical Medicine and Parasitology, 40, 21-23). Reasonsfor primaquine failure include poor quality or inappropriate storage of the drug tablets, poor patient compliance, malabsorption, and intrinsic resistance or low sensitivity of P. vivax to the drug. Which of these factors was responsible for the treatment failure in the casereuorted bv Garavelli and Corte is uncertain. Andrea Canessa Giovanni Mazzarello Mario Cruciani Dante Bassetti Department of Infectious and Tropical Diseases University of Genoa Genoa, Italy 9July 1992
[Other, similar letters on this topic have been received.Editor.]
Chloroquine-resistant Plasmodium vivax: a reply The remarks made bv Drs Lovola and Rodriguez, Drs Bada and Cabezosand br Cane&a et al. [aboverconcerning my paper (Garavelli et al., 1992: Transactions, 86, 128) are interesting. As pointed out in the paper, it was not possible to investigate the response of the strain to chloroquine in vitro nor to determine the level of chloroquine in the patient’s serum., but the reappearance of Plasmodium vivax parasitaemla was attributed to chloroquine resistance rather than to persistent hepatic infection becausethe final resolution was obtained after treatment with mefloquine, a blood schizontocide. At the time of writing (July 1992), the patient is in good health and periodical examination of stained blood films has not revealed any further episodesof parasitaemia. Pietro Luigi Garavelli Deaartment ofInfectious Diseases General Ho&d Alessandria, Italy
2July 1992
The investigator must take every precaution to protect the nrivacv of the subiect and of all data that could associate speci?icinformahon with the subject. In particular, investigators should make arrangements to protect the confidentiality, for example by omitting information that may lead to the identification of individual subjects. People, organizations carrying out clinical trials, and those involved in the publishing of the results must pay close attention not only to the importance of confidentiality, but also to other ethical rules; for example, review by an independent committee and informed consent of patients. I’. Goyot 28, rue des Pins 91330 Yerres France
26 March 1992
Ethics and clinical trials: a reply In reply to the letter by Dr P. Goyot [above], I wish to confirm that the clinical trial on the association of antimonials and allopurinol in the treatment of mucocutaneous leishmaniasis in Bolivia (Antezana et al., 1992: Transactions, 86, 31-33) was carried out according to ethical rules defined in the Declaration of Helsinki, the only recommendations available at the time when the trial was initiated. The following recommendations were particularly resnected: adherence to previously defined inclusion criteria for patients, signat;re of infbrmed consent for all patients included. and definitive cure of natients in caseof failure of the t&ted protocol. During
[Other, similar letters on this topic have been received.Editor.]
Chloroquine-resistant Plasmodium vivax: a reply The remarks made bv Drs Lovola and Rodriguez, Drs Bada and Cabezosand br Cane&a et al. [aboverconcerning my paper (Garavelli et al., 1992: Transactions, 86, 128) are interesting. As pointed out in the paper, it was not possible to investigate the response of the strain to chloroquine in vitro nor to determine the level of chloroquine in the patient’s serum., but the reappearance of Plasmodium vivax parasitaemla was attributed to chloroquine resistance rather than to persistent hepatic infection becausethe final resolution was obtained after treatment with mefloquine, a blood schizontocide. At the time of writing (July 1992), the patient is in good health and periodical examination of stained blood films has not revealed any further episodesof parasitaemia. Pietro Luigi Garavelli Deaartment ofInfectious Diseases General Ho&d Alessandria, Italy
2July 1992
The investigator must take every precaution to protect the nrivacv of the subiect and of all data that could associate speci?icinformahon with the subject. In particular, investigators should make arrangements to protect the confidentiality, for example by omitting information that may lead to the identification of individual subjects. People, organizations carrying out clinical trials, and those involved in the publishing of the results must pay close attention not only to the importance of confidentiality, but also to other ethical rules; for example, review by an independent committee and informed consent of patients. I’. Goyot 28, rue des Pins 91330 Yerres France
26 March 1992
Ethics and clinical trials: a reply In reply to the letter by Dr P. Goyot [above], I wish to confirm that the clinical trial on the association of antimonials and allopurinol in the treatment of mucocutaneous leishmaniasis in Bolivia (Antezana et al., 1992: Transactions, 86, 31-33) was carried out according to ethical rules defined in the Declaration of Helsinki, the only recommendations available at the time when the trial was initiated. The following recommendations were particularly resnected: adherence to previously defined inclusion criteria for patients, signat;re of infbrmed consent for all patients included. and definitive cure of natients in caseof failure of the t&ted protocol. During
