Imports disallowed as NMRA frowns on Cuban drug to cure diabetic foot ulcers Despite recommendations by eminent doctors to save lives

by Suresh Perera

In a shocking turnaround, ambitious plans to import an innovative, life-saving Cuban drug to cure advanced foot ulcers usually associated with high amputation risk has been blocked, notwithstanding some of Sri Lanka’s leading vascular and transplant surgeons recommending the injectable medicine to offer a new lease of life to scores of suffering diabetic patients.

With an 86.5% success rate in 25 plus countries, Heberprot-P was launched in Sri Lanka one year ago after a series of positive clinical trials in government health facilities, but bureaucratic bungling has closed the door for its import resulting in more and more amputations and deaths, medical officials asserted.

In the backdrop of some of Sri Lanka’s top vascular and transplant surgeons, including Dr. Rezni Cassim, Dr. Nalaka Gunawansa, Dr. Ranjuka Ubayasiri and Professor of Surgery, Mandika Wijeyaratne and Consultant General Surgeon, Dr. Sudhira Herath also giving the green light for its use in Sri Lanka, Cuba is concerned over the "dragging of feet" in granting clearance for imports, they said.

Diabetes Mellitus is one of the biggest killers in Sri Lanka, where non-communicable diseases have surged over the years. Between 10% - 30% of diabetic patients need amputation due to chronic wounds.

The Sunday Island learns that Cuba’s Ambassador in Sri Lanka, Florentino Batista Gonzalez, was scheduled to meet with Dr. Rajitha Senaratne to discuss the issue, but the appointment had to be canceled as the Health Minister suddenly fell ill and was taken to Singapore for medical treatment.

The envoy declined to discuss specifics, but stressed that the Cuban biotech and health related industry is highly regarded worldwide for its innovation and stringent scientific standards. "It has a recognized success record".

During President Obama’s recent visit to Cuba, the collaboration in this area was mentioned by the US leader in his official speech as an acknowledgment of the rapid advances made by the Cuban biotech industry, he noted.

Heberprot-P has proven to be highly successful in many countries where it has been widely used by professional healthcare providers, Ambassador Gonzalez told The Sunday Island.

Two eminent Cuban medical experts, Dr. Pedro César Goicoechea Díaz and Dr. Sergio Perez were in Colombo for the March 2015 product launch, which was also attended by Sir Michael Hirst, a Britisher, who served as President, International Diabetes Federation.

Asked what was preventing the registering of Heberprot-P in Sri Lanka, health officials said that the National Medicines Regulatory Authority (NMRA) has insisted on US FDA (Food and Drug Administration) certification.

"This is an impossibility as Cuban products were not certified by the USA due to the economic restrictions against Havana", they pointed out.

"The door has not been shut on this medicine. What we want is certification from a Preference Regulatory Authority (PRA)", interjected Prof. Lal Jayakody, NMRA’s Chairman.

"We have already discussed this drug in the Medicines Evaluation sub committee and a multi-tasked and multi-skilled group will decide on it", he explained.

Patients are dying while the NMRA is trying to split hairs. Will so many countries, including Cuba, Argentina, Colombia, Costa Rica, Ecuador, Guatemala, Mexico, Paraguay, Peru, Uruguay, Venezuela, Russia, Turkey, Kuwait, Vietnam, and the Philippines approve use of Heberprot-P without evaluating its safety and efficacy?, health officials queried.

"With so many essential drugs now in short supply, it’s the efficacy of the NMRA which needs to be evaluated", they opined. "The industry has been turned topsy-turvy".

There is, by and large, a standard criteria to evaluate medicines. It cannot be done the way politicians, doctors and interest groups want. These are very costly injections and if their efficacy cannot be proven, they are as good as mud water, the Chairman elaborated.

There is no dispute that US FDA approval cannot be secured for a Cuban product, but PRA certification could have been sought from the EU, Australia or Canada to establish the drug is being widely used, Jayakody pointed out.

"The professor should know that Cuba was shut out by the whole world and it’s only now that the gates are gradually opening", industry officials said.

Even New Zealand uses Heberprot-P on patients, but the NMRA refuses to accept it saying the country is not listed as a PRA certifier, they said. "This is ridiculous".

"Moreover, why should we necessarily look beyond our shores when Rs. 10 million worth of Heberprot-P injections were used for a clinical observation in Sri Lanka and based on its findings, Mandika Wijeyaratne, one of the country’s leading professors of surgery, recommended its use", they noted. "Four other vascular surgeons have also sanctioned it".

Surely, these eminent medical men know better in a Sri Lankan context than a certification from a foreign country, they said. "The clinical trials done here also yielded the desired results".

Diabetic foot ulcer is a principal diabetic complication. It has been shown that diabetic patients have decreased growth factor concentrations in their tissues, particularly epidermal growth factor. Growth factor shortage impairs wound healing, which leads to chronic non-healing wounds and sometimes eventual amputation.

Ischemic diabetic foot ulcer is the most difficult to treat and confers the highest amputation risk. Injecting epidermal growth factor deep into the wound bottom and contours encourages a more effective pharmacodynamic response in terms of granulation tissue growth and wound closure.

Epidermal growth factor injected into the ulcer matrix may also result in association with extracellular matrix proteins, thus enhancing cell proliferation and migration.

Heberprot-P, the first of its kind developed at the Centre for Genetic Engineering and Biotechnology (CIGB) of Havana, Cuba for the cure of advanced foot ulcers. The drug contains the human recombinant Epidermal Growth Factor (EGF) as the active pharmaceutical ingredient, which helps to stimulate and sustain the healing process of the wounds and complex ulcers on the lower limbs at terminal stages in diabetic patients.

One year has lapsed since the launch of Heberprot-P in Sri Lanka and the NMRA is still sitting on the approval, while patients are dying, the officials said. "It’s a pathetic situation".

"There is an evaluation process that has to be adhered to before giving the go-ahead for registration", Jayakody shot back.

There are oncology-related injectable medicines also which are very costly, but the government as well as patients who can afford purchase them as the priority is to save lives, the officials pointed. "It is unacceptable to shut out proven healthcare products just because they are expensive".

Ten pharmaceutical companies have made fresh representations to the powers-that-be on what they described as the "lackadaisical attitude of the NMRA", which has led to a dearth of many essential drugs in the market.

Even Panadol drops given to infants and some vital drugs prescribed for patients with mental disorders are in short supply, they asserted.
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