Final report finds T&T cancer patients suffered severe radiation injuries at Lara Treatment Centre

(Trinidad Express) A multi speciality team of radiation experts tasked with conducting a medical evaluation of patients exposed to radiation overdoses, ranging from four to 20 per cent more than had been prescribed for them at the Brian Lara Cancer Treatment Centre (BLCTC), have found clinical evidence of “severe radiation injury”.

The final report of the International Atomic Energy Agency (IAEA) January 2012 Assistance Mission to Trinidad and Tobago found that some of the 223 patients who were adversely affected by over-radiation at the BLCTC had: “clinical evidence of such severe radiation injury that an experienced clinician cannot help but think that even an approximate 15 per cent overdose may have been a contributing factor in causing an increased severity of the injuries in some of these patients”.

The report comes three years after a radiotherapy overdose incident at the private Port of Spain cancer treatment facility, owned by Medcorp Ltd, and 18 months after the PAHO (Pan American Health Organisation) concluded in a secretly-held report commissioned by the Chief Medical Officer (CMO) that patients had not only been given excessive doses of radiation over an 18-month period up to June 2010, but that at the time of writing of the PAHO report in September 2010, they had not been informed about the radiation overdose or “the potential impact on their well-being and quality of life”.

When the first report of a radiation misadministration was leaked to this newspaper in July 2010, the management of BLCTC denied there was a radiation overdose and attempted to shift blame to the senior physicist who discovered the error, Damian Rudder, accusing him of sabotage. Affected patients and their families were anguished by news of an overdose, provided with confusing information about the clinical and medical physics aspects of their treatment and overdose levels and were not provided with any form of counselling or follow-up care by BLCTC or the state regulators who licensed Medcorp Ltd to operate a private radiotherapy treatment facility on Fitzblackman Drive in Woodbrook, Port of Spain.

When the PAHO audit confirming the Rudder finding was leaked to the Sunday Express ten months later, the cancer treatment facility countered that none of the affected 223 patients had been injured by the overdose. The centre, which failed to contact the affected patients, in a damage containment effort, went on to assert in full page newspaper advertisements that “no patients were found to have suffered from toxic side-effects of over-radiation”.

Forced to take a public stand by the leak of the report, Health Minister Dr Fuad Khan and his CMO Dr Anton Cumberbatch, who previously did nothing with the findings of the Rudder and PAHO reports, in a hastily-called media conference on July 6, 2011, made a public call to the affected patients to return to the cancer centre which had not only over-radiated them but had failed to inform them there was a radiation overexposure and that they were at risk of late side effects of irradiation.

Khan, a medical doctor, also announced his government’s intention to have the IAEA conduct a detailed probe into the circumstances relating to the radiation overdose incident and to map out a treatment plan for the affected patients. The findings of the world authority and rigorous advocate for safety and security in the use of nuclear science and technology, the IAEA, dramatically contradict the centre’s claim that no patients were harmed beyond the complication of routine radiation therapy.

Yesterday, Minister Khan confirmed that he has had the IAEA report for several weeks now but was still to get round to reading the full report or to speak to the affected parties. He said he planned to do so soon.

The IAEA audit was confined in the main to four clearly defined objectives:

• To conduct a medical assessment and evaluation for a patient group of ten per cent of the affected 223 patients. The team in fact saw a patient group of 13 per cent

• Provide patient treatment advice for the affected patients

• Evaluate the extent to which past recommendations made to the Government of Trinidad and Tobago by previous PAHO/IAEA missions have been implemented, and

• To gather, record and evaluate information on the event and compile appropriate records for a possible future formal accident report.

The five-member team, headed by retired director of the Radiation Emergency Centre and renowned radiation oncologist Dr Albert Lee Wiley, were specifically told not to investigate the why or how the radiation error occurred. According to the report, which was released to the Kamla Persad-Bissessar government early last month, it was “deemed not to be within the scope of the mission to perform an independent review to assess whether the radiation levels reached a specific percentage”.

The IAEA radiation experts were also made signatories to a strict confidentiality agreement. The report, a copy of which has been obtained by the Sunday Express, noted that: “All signatory parts agreed that statements, information, reports or data which will result as an outcome of this mission will not be referenced and will not be made available as evidence in any investigation related to this event.”

Patient evaluations for a group of 30 of the affected 223 were conducted over the period January 23-26 this year at the St James Medical Complex, Port of Spain. Each evaluation, according to the report, consisted of individual patient interviews with limited, focused physical examinations and a review of available patient data and records, including dates of treatments, prescribed dose, estimated treatment dose and estimated overdose.

The report noted that: “One aspect of the medical mission was to identify and assess the extent of any specific medical injury for each of the 30 patients that might be related to the known, specific amounts of radiation overexposure as described in the physics report.”

According to the Dr Wiley team, this was not an easy task.

The IAEA experts explained why this was so:

1. “A number of patients did experience signs and symptoms of radiation injury

2. Even properly delivered radiation therapy has a certain probability of side effects and this probability of side effects (tissue injury) rises with increasing dose for all types of tissues (some tissues more than others), as well as whenever chemotherapy and surgery are combined with the radiotherapy, and

3. Even though the probability of radiation injury to normal tissues is known to be correlated with dose, the statistical variations of the probability of such injury from the clinical data are large.”

“Therefore, since the radiation overdose is relatively small for these patients, it is difficult at this time to clearly and unequivocally state that the observed injuries in these patients are in fact due to the specifically reported overdose for these 30 patients. Further the Dose Volume Histograms (DVH) that were provided for each patient all seem to confirm that (even for the overexposure dose levels) the normal tissues at risk are within commonly accepted complication rate probabilities,” said the report.

The IAEA experts, however, made clear that: “The radiotherapy speciality of medicine, like most specialties, does not have the precise science and statistics that we might wish for and sometimes clinical experience must ‘weigh in’. That being said, some of these patients (as described in the appendix) had clinical evidence of such severe radiation injury that an experienced clinician cannot help but think than even an approximate 15 per cent overdose may have been a contributing factor in causing an increased severity of the injuries in some patients.”

The centre which has remained steadfast in its claim that no patient was adversely affected by the radiation overexposure has refused outright the requests of several of the affected patients for the payment of medical care related to the radiation overdose, including bills incurred at an associate company, St Clair Medical Centre, 18 Elizabeth Street in Port of Spain.

St Clair Medical, which is also owned by Medcorp Ltd, is the private hospital of choice for key members of the ruling administration, including Prime Minister Persad-Bissessar, who was treated at the facility for swollen ankles late last year. The Prime Minister’s husband, Dr Gregory Bissessar, also underwent heart surgery at St Clair Medical last September. Education Minister Dr Tim Gopeesingh said the Prime Minister’s husband chose the private facility over a public hospital because his “good friend”, Dr Kamal Rampersad, was an integral part of the St Clair team of doctors.

Dr Rampersad, who received a national award for his contribution to medicine last September, is a co-founder and managing director of Caribbean Heart Care Medcorp Ltd, another Medcorp Ltd company.

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