Norton directs release of seized GPHC kidney drugs for proper storage, overseas testing

Despite an ongoing probe by the Government Analyst-Food and Drug Department (GA-FDD) into the presence of banned kidney drugs at the Georgetown Public Hospital Corporation, Public Health Minister Dr George Norton has asked that the drugs be released and he says samples would be sent to Jamaica for testing.

The medication has been in use at the hospital for five years.

“I wrote a letter to say to [GA-FDD Director] Mr [Marlan] Cole that he should release the seizure order so that we can put it in a place that we think it should be stored in… and secondly we can send that medication to get it tested in Jamaica to see if it is effective or not,” Norton told Stabroek News last Friday, moments after his end-of-year press conference.

Stabroek News had reported last month that a significant quantity of Erythropoietin injections, made in India and purchased for use by kidney disease patients, was seized by the GA-FDD as the Indian manufacturers have reportedly been banned in the United States. The seizure took place on September 30, after the department went to investigate following a complaint.

The GPHC subsequently said that the department acted rashly.

Norton, when asked about the seizure, said the ministry could not intervene unless the drugs were released. “We can’t touch it… you can’t touch it unless you get a release from the Food and Drug Department,” he explained.

The seized injections were not removed from the GPHC’s premises but were sealed off by officials of the GA-FDD and left in the bond.

“…That medication was coming into this country five years ago and we were using it,” Norton said before adding that the department “coincidentally” got a report from a local drug supplier that the GPHC was not storing the injections properly. Based on what the minister said, the drugs were seized specifically because they weren’t being stored at the required temperature.

In a letter written to then GPHC Chief Executive Officer (CEO) Michael Khan days after the seizure, the GA-FDD said it was observed that the Vintor-Erythropietin injection, manufactured by Gennova Biopharmaceuticals Ltd, India, and the Wepox-Recombinant Human Erythropoietin injection, manufactured by Wockhardt Limited, India, were present in the bond.

The injections are both used to stimulate bone marrow to produce blood. This production process is heavily dependent on hormones produced by the kidneys. Patients who have renal failure are unable to produce enough of this needed hormone and as a result are given the hormone in the form of an injection.

The letter said it was found that the drugs were being stored at temperatures between 17 and 25 degrees Celsius and not the recommended 2 to 8 degrees Celsius storage conditions recommended by the manufacturers—a situation which could adversely affect the efficacy and potency of the product’s intended therapeutic use.

According to the letter, neither brand of injection was fit for use. In the case of the Vintor-Erythropietin injection, the plant where it was manufactured was “banned” by the United States Food and Drug Administration (FDA) for violating good manufacturing (GMP) standards and this resulted from the company “manipulating results of analysis for batches tested to derive desired (favourable) results of analysis,” the letter said. With regard to the second one, the GA-FDD stated that its use had also been banned for a similar reason and its sale was stopped in the United States because the FDA discovered “that results of the analysis were linked between ‘trial drugs’ and official use.”

Following the seizure, the GA-FDD wrote to Director of Medical and Professional Services Dr Sheik Amir, who was acting CEO at the time. Amir was told in the letter that the GA-FDD was in the process of retrieving additional information regarding the manufacture, registration, use, sale and distribution of the injections through the World Health Organization.

In the letter, it was indicated that in order to continue and complete the investigation, the department urgently needed the exact name and address of the companies that supplied the drug to the hospital; the exact quantities that were supplied and the period of time the drug was supplied to the hospital prior to the September 30 seizure.

Stabroek News was unable to ascertain if the GA-FDD has been furnished with the requested information.

Amir, when approached by this newspaper, had said that he was disappointed with the way the department handled the matter, particularly since there was no public recall of the drug. He opined that if it was indeed found that there was a problem with the drug, an advisory should have been sent out,

thereby giving the hospital an opportunity to source a replacement drug and avoid a possible wastage of money.

Amir acknowledged that the hospital had been using this drug for some time and it is not the only medical institution doing so.

He stressed that the seized drug had entered the country legally and would have been cleared by both Customs and the Food and Drug Department before it ended up in the hospital’s bond. He used the opportunity to question why the drug was allowed into the country in the first place if there was a problem with it.

This newspaper has learnt that the seized drug was imported by the International Pharmaceutical Agency (IPA) and was also distributed to other medical facilities for use.

Given the seizure, the GPHC has had to secure a replacement drug from Ansa McAl and this is now being administered to the hospital’s kidney patients.