Drug Shortage: Scientists Seek New Cure for Overlooked Leishmaniasis 

APP

Peshawar: In a collaborative effort spanning various fields of expertise, voices from the realms of medicine, entomology, dermatology, and zoology are amplifying calls for the initiation of clinical trials aimed at discovering alternative treatments for cutaneous leishmaniasis (CL). 

This skin ailment, often overlooked despite its prevalence in tropical regions, has now garnered attention as the third most significant vector-borne disease, trailing only behind malaria and dengue. Experts are voicing their concerns in response to the stark limitations posed by the current treatment landscape, which heavily relies on meglumine antimoniate.

This decades-old imported drug stands as the primary recourse for treating CL, demanding a rigorous regimen of injections administered over 21 to 30 consecutive days.

However, the efficacy of this treatment approach can be variable, and its demanding nature presents considerable challenges for patients.

Given these pressing concerns, the push for clinical trials to explore alternative treatment avenues has gained momentum. Such trials are seen as crucial steps toward addressing the limitations of the existing treatment protocol.

By diversifying treatment options, researchers aim to improve efficacy, enhance patient safety, and ultimately alleviate the burden of CL on affected communities. The collaborative effort of experts across multiple disciplines underscores the urgency and significance of finding innovative solutions for CL.

Through rigorous scientific inquiry and collective expertise, these efforts aim to pave the way for more effective and accessible treatments, marking a pivotal milestone in the fight against this neglected tropical disease.

Meglumine antimoniate is not produced locally, and health authorities completely rely on its procurement through imports by international organizations such as the World Health Organization (WHO), making it difficult to properly treat this parasitic disease and widening its horizons from endemic to non-endemic regions due to rapid urbanization, climate change, and large-scale population dispersion,  they explained. 

In many areas, the doses each patient receives are insufficient because of the drug’s limited availability and the lack of suitably trained medical staff.

Recent reports regarding the exhaustion of glucantime vial stock in Khyber-Pakhtunkhwa (KP) gave impetus to an expert call.  The bulky stock of 180,000 jabs imported by the Health Department of KP through WHO in 2018 after the outbreak of CL in the province has been finished in December 2023, and we are currently short of medicine to treat the patients, disclosed an entomologist at Integrated Vector Control Programme KP, Salauddin Marwat.

Due to a lack of first-line medicine, doctors are opting for alternate treatment procedures, including cryotherapy, which involves applying minor volumes of liquid nitrogen at -196 °C to the affected portion of the skin once or twice weekly for up to six weeks, and thermotherapy, which involves applying heat to the scar.

The Integrated Vector Control Programme has supplied equipment for both therapies in some leishmaniasis hotspots in KP, including DI Khan, Mohmand, and Karak, for treatment.

For proper treatment through glucantime injections, patients are visiting centers established by Medicines Sans Frontier (MSF), a representative of an international medical humanitarian organization, in Khyber-Pakhtunkhwa, Salauddin said. 

After analyzing data from the Public Health Department indicating a sharp increase in leishmaniasis infection in the region and its impact on the physical and mental health of patients, it is time for the Drug Regulatory Authority (DRAP) to take measures for the availability of a proper, latest, effective, and affordable medicine for its treatment, suggested Dr Rafiq Hayat Malezai, District Health Officer (DHO) of Mohmand District, a hotspot of leishmaniasis registering around 5,283 cases in 2023.

In 2023, around 25273 cases of CL will have been recorded in Khyber-Pakhtunkhwa, registering a spike of 7093 cases from the preceding year. Dr Rafiq informed me that he has around 439 cases of follow-up to be examined in the coming few days, but due to a dearth of medicine, he is unable to provide treatment to patients. 

While realizing the surge in the spread of CL infection during the last few years from its pocketed ranges to other parts of the country, it’s time to give serious consideration to its prevention and cure by involving different departments, including health, epidemiology, entomology, and microbiology, suggested Dr Muhammad Akram, former Chairman of the of the Zoology Department at Peshawar University with a PhD in CL.

Dr Akram also insisted on the advanced study of parasites causing CL and the control of sand fly vectors involved in the spreading of the contagion. The majority of the medicines used for the treatment of leishmaniasis are around 70 years old and of the third generation, not showing better results, he claimed.

Dependence on the World Health Organization (WHO) should be ended by allowing some pharmaceutical companies to prepare or import the required stock of glucantime or some other relevant medicines for provision to patients at affordable prices, Akram went on to say.

Apart from cryo and thermotherapies, we are also prescribing Miltefosine, a broad-spectrum antimicrobial and anti-leishmanial drug, as an alternative to glucantime, which is easily available in the open market, informed Dr Asad Zahoor, Focal Person for Leishminaisis Treatment in Karak District, where around 11,000 cases are reported in 2023.

 However, some dermatologists were of the view that the available stock of glucantime and related medicines on the open market is not reliable and is pirated. In so many cases, medicine obtained from open markets, especially those famous for selling smuggled goods, did not give the desired results and was found to be spurious, shared Dr. Hafza Usman, a dermatologist serving at Kuwait Teaching Hospital in Peshawar.

On August 5, 2022, DRAP also issued an alert about the presence of falsified glucantime vials on the market purported to be prepared by TILLOTTS Pharma AG, Switzerland. The company later confirmed over contact with DRAP that it does not manufacture this product.

All pharmacists and chemists working at distributions and pharmacies were alerted and directed to immediately inform DRAP of the presence of this falsified product in the market or any information related to the supply of this falsified product.

Realizing the increase in several patients and the difficulties faced in getting proper treatment, MSF is planning to hold a CL clinical trial to investigate alternative treatments for cutaneous leishmaniasis in Pakistan, according to Dr. Muhammad Shoaib, Medical Coordinator at MSF. 

 Dr Shoaib said in these randomized control clinical trials, different treatment methods will be compared with the current first-line drug use. 

Our clinical trial is already in progress in Quetta, and if we get approval from DRAP (Drugs Regulatory Authority Pakistan), clinical trials will get started in Peshawar to find out alternative treatment measures for cutaneous leishmaniasis, Dr Shoaib added. 

 Since it intervened in 2018 for the treatment of leishmaniasis in Khyber Pakhtunkhwa, MSF has so far treated around 11,260 patients in its three centers, including two in Peshawar and one in Bannu. There is an acute shortage of glucose injections in Khyber Pakhtunkhwa, and presently we don’t have the medicine due to biennial closures, confirms Dr Babar Alam, Head of WHO in KP. 

Dr Babar said our fiscal year ends in December, and this December was the closure of two years. Now work plans for the next two years are in the process of finalization, after which WHO can procure a new stock of glucantime, Babar informed. 

He said a meeting is also going to be held soon with representatives of the KP Health Department and MSF to chalk out future lines of action to overcome the shortage of medicine. 

A demand for acquiring glucantime on an urgent basis has been forwarded by the Health Department of Khyber-Pakhtunkhwa, and if approval is granted, medicine would be purchased through WHO at a cost of around Rs 40 million, said Dr Irshad Ali Roghani, Director Public Health KP.

Dr Irshad said WHO and MSF have also been contacted to arrange medicine on an urgent basis.  An appeal has also been made to MALC (Marie Adelaide Leprosy Center) for arranging medicine, he went on to say. 

Dr Roghani said the KP Health Department is doing its best to procure the required stock of glucantime either by purchasing it through WHO or getting a donation from any international humanitarian organization.

While concurring with the call of experts to find a new cure procedure for leishmaniasis, Dr Roghani said the health department is already working on it with the collaboration of Khyber Medical University (KMU).

“We are working on the preparation of a local product to serve as a useful and affordable antileptic drug, which hopefully will become successful in the coming few months,”  Dr Roghani hoped.

The feature report was released by APP Peshawar Bureau on March 17, 2024.