Drug Shortage Prompt Research For Alternate Cure Of Overlooked Leishmaniasis

PESHAWAR, (UrduPoint / Pakistan Point News - 17th Mar, 2024) Experts in medicine, entomology, dermatology and zoology are raising voices for holding clinical trials to find an alternate treatment for cutaneous leishmaniasis (CL), an overlooked skin ailment of tropical regions emerging as the third most important vector-borne disease after malaria and dengue.

The concern by experts has been exhibited in the wake of the limited cure options due to complete reliance on Meglumine antimonite, a decades-old imported drug used as first-line treatment for CL requiring injections for 21 to 30 consecutive days.

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, making it difficult to properly treat this parasitic disease widening its horizon from endemic to non-endemic regions due to rapid urbanization, climate change and large scale dispersion of population,” they explained.

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

Recent reports regarding exhaustion of glucantime vials stock in Khyber Pakhtunkhwa (KP) gave impetus to experts’ 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, applying minor volumes of liquid nitrogen at -196C to the affected portion of the skin once or twice weekly for up to six weeks, and Thermotherapy, applying heat at the scar.

The Integrated Vector Control Programme has supplied equipment for both therapies in some leishmaniasis hotspots of KP including D.I.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 told APP.

“After analyzing data of 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 availability of a proper, latest, effective and affordable medicine for its treatment,” suggested Dr. Rafiq Hayat Malezai, District Health Officer (DHO) Mohmand District, a hotspot of leishmaniasis registering around 5,283 cases in 2023.

In 2023 around 25273 cases of CL have been recorded in Khyber Pakhtunkhwa, registering a spike of 7093 cases from the preceding year.

Dr. Rafiq informed 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 Zoology Department Peshawar University with Ph.D. on CL.

Dr. Akram also insisted for the advanced study of parasites causing CL and 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 World Health Organization (WHO) should be ended by allowing some pharmaceutical companies to prepare or import 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 thermo therapies, 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 medicine in open market is not reliable and pirated.

“In so many cases, medicine obtained from open markets, especially those famous for selling smuggled goods, did not give 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 in the market purported to be prepared by TILLOTTS Pharma AG, Switzerland. The company later confirmed over contact by 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 upon 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 difficulties faced in getting proper treatment, MSF is planning to hold CL clinical trial to investigate alternative treatment for cutaneous leishmaniasis in Pakistan,” informs Dr. Muhammad Shoaib, Medical Coordinator MSF.

Talking to this scribe, 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 leishmaniais, Dr. Shoaib added.

Since it intervened in 2018 for the treatment of leishmaniasis at 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 Glucantime 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.

Talking to APP, 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 for 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 Heath Department and MSF to chalk out future lines of action to overcome the shortage of medicine.

“A demand for acquiring glucantime at urgent basis has been forwarded by the Health Department of Khyber Pakhtukhwa 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 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 new cure procedure of 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 and hopefully will become successful in the coming few months", Dr. Roghani hoped.