Punjab’s caretaker health minister Dr Javed Ikram revealed that a drug that caused loss of vision in multiple patients was administered illegally and without informed consent.
Ikram made the revelations in a press conference in Lahore on Tuesday, where he added that Avastin is normally used for cancer treatments, especially for liver and kidneys, and is administerd intravenously. He also revealed that there were a total of 68 cases of the drug’s use in eyes.
He added that the injection of the drug into eyes is an off-label use and has not been been approved by either the Drug Regulatory Authority of Pakistan and the drug authorities in US or India.
Ikram said that off-label use is common in many instances but prior permission has to be taken from DRAP, which was not done in this case.
He added that good clinical practices also include getting ‘informed consent’ from patients, which is best done in local languages. However, informed consent was not taken from the patients either.
Ikram said that the government had initially placed a blanket ban on the use of the drug but it has now been allowed for use by cancer patients intravenously. He added that the two batches, 3218 and 3239, that had been questioned were being analysed and will be destroyed if infection found.
He added that the government has decided to order that informed consent will be necessary for the use of the drug. He added that the consent will have to be taken on video recording rather than just writing.
