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Thursday March 28, 2024

Pinstech tampered with report to get clean chit from SC

Cancer injections

By our correspondents
May 08, 2015
ISLAMABAD: The Pakistan Institute of Nuclear Science and Technology (Pinstech) secured a clean chit from the Supreme Court by tampering with facts in a sou moto case following allegations that it had been supplying contaminated cancer-diagnostic injections that could cause cancer instead of diagnosing it.
The News is in possession of the internal correspondence confirming the presence of undesirable radio-nuclides in the injections supplied to the cancer hospitals but it was concealed from the apex court.
In the reply submitted in April 2014 before the then Chief Justice Tassaduq Hussain Jillani-led three-member bench, Pinstech had denied outright such contamination saying the internal inquiry ordered to investigate the allegations found everything in order. Trusting that Pinstech couldn’t dare misrepresenting the facts, the SC had disposed of the sou motto notice taken on The News story published on February 25, 2014.
Not only SC, Pakistan Nuclear Regulatory Authority that certifies such products was also kept in the dark through faking the results of these contaminated injections. Pinstech refused to offer comment over this misrepresentation of facts when approached by this correspondent through written questions emailed to the spokesperson of Pakistan Atomic Energy Commission (PAEC).
“The inquiry committee thoroughly checked the QC (quality control) and QA (quality assurance) record of all the molybdenum-99 batches produced at Pinstech and found it in order as per SOP,” is what Pinstech had submitted before the SC that formed the basis of disposing of the case.
However an audit conducted by Moody International Certification Group in February 2013 of a batch of Technetium-99m Generator (also known as TC-Generator) pointed out serious problems.
TC-Generator produced at Pinstech is an injection used for imaging and studying organs such as brain, heart muscles, thyroids, lungs, liver, gallbladder, kidneys as well as skeleton and blood for detecting signs of cancer. One batch of TC-Generator is sufficient for administering injections to at least 500 patients.
However, higher amount of Molybdenum-99 in TC-Generator could destroy the white blood cells, weakening the immune system and causing cancer instead of diagnosing it. The abnormal presence of Molybdenum was also pointed out during the audit, also admitted by Pinstech in reply to auditor, reveal documents available with The News.
While the quality of all the batches produced since 2011 were questioned by a Pinstech’s whistleblower who was deputed for quality control, in a 2013 letter to the then chief justice Iftikhar Muhamamd Chaudhry, an audit by Moody International Certification Group had also endorsed this but his findings were not shared during the sou motto case.
“Values/Molybdenum-99 (0.6) were found much higher as per specified values (Standards of European Pharmocopia of 0.1%). Register indicates that 37 generators were prepared from this batch and distributed to various hospitals,” reads the observation of Jehangir Ahmed, the auditor of Moody International Certification Group on February 12, 2013.
His observation was acknowledged by the head of quality control, Dr. Samina Roohi who while responding to the auditor on the same date admitted: “This problem has occurred due to the carelessness and lack of training.”
The News approached the spokesman only to get back the following reply: “The questions are related to an issue which was taken up by the Honourable Supreme Court of Pakistan and after detailed deliberations and inquiries/investigations, the honourable apex court was fully satisfied and, therefore, decided the case in favour of PAEC. After the decision of the court, raising of the settled issues may not be in order and against the dignity of esteemed supreme court.”
When asked for his viewpoint as to why facts were misrepresented before the SC, the spokesman answered: “We have replied to you whatever we deem appropriate. You are free to conclude whatever you deem appropriate. I will not be able to comment more than what has already been stated.”
For the beginners, this issue was first brought to the SC notice when a Pinstech scientist deputed on quality control of TC-Generator, Riaz Pasha, wrote a letter to the then chief justice Iftikhar Muhammad Chaudhry who had directed the chairman PAEC to hold an immediate inquiry, also involve the complainant in the probe and report back to the apex court. Justice Chaudhry retired in the meanwhile and no inquiry was conducted, let alone sharing the findings with the SC.
When the matter was brought to public attention by The News in February 2014, the then-chief justice Tassaduq Jillani took a rare sou motto notice, directing the PAEC to conduct inquiry into the allegations with the assistance of Riaz Pasha and report back to the apex court. While Pasha was kept at a distance, a favourable inquiry clearing all concernedwas submitted before the SC that eventually disposed it of.
TC-Generator is made of Mo99-TC99 and is used along with a medicine for imaging and studying organs suspected to have contracted cancer. Mo (Molybdenum)-99 is produced in a nuclear reactor at Pinstech. Earlier imported from South Africa, it was decided in 2011 to start production in Pakistan that saved money but the decision had a side effect - a risk to lives of thousands of Pakistanis.
In addition to 14 cancer hospitals of Pakistan Atomic Energy Commission, several other hospitals use these injections bought from Pinstech. “A number of Mo99-Tc99 batches supplied to various cancer hospitals were contaminated with undesirable radio nuclides such as Cesium-137, Strontium-90/Yetrium-90 and Ruthinium-103,” reads a 2013 complaint sent to the SC by Muhammad Riaz Pasha, former principal scientist at Pinstech, who oversaw quality control procedures of Mo99, an integral component of TC-Generator.
“The (final) results are not based on actual analysis but are tampered to appease the seniors/high-ups for receiving certifications and licences from PNRA (Pakistan Nuclear Regulatory Authority),” his complaint had further noted.
All this has been done, he goes on, without “considering those less fortunate patients who are suffering from cancer and are being injected with undesirable radioactivity.” Pasha also dispatched tampered results to the court as evidence to support his claim.
Radio Strontium-90 is known to cause cancer as a result of damage to genetic materials in cells, he explains in his applications to SC’s HR cell. Likewise, Ruthinium-103 is among the long-lived radio nuclides that have produced and will continue to produce increased cancer risks for decades to come for patients administered contaminated injections, he further noted. These radio-nuclides, if injected to patients, can replace calcium with bones. “This is quite alarming and therefore requested that it is an important issue and may please be looked into,” he informed the apex court.