In response to the findings, the State Agency of Medicines (ZVA) pulled Rigvir sales in Latvia and advised sellers abroad to cut sales as well on March 29. Patients are advised to contact their physician to find alternative treatment.
Two years ago, three medical organizations, including the Latvian Oncology Association, turned to the Health Ministry expressing concern that research and publications used to establish the credentials of Rigvir treatment were of poor quality and scientifically questionable.
The question is, then, as to why it took so long for the medicines watchdog to test Rigvir samples?
ZVA rep Dita Okmane told LTV that each year the watchdog tests about 40 to 50 medicines. "We can't test all of them in-house. Rigvir had been on the test list for several years," she said, adding that the process was sped up due to pressure from patients and doctors.
ZVA has not decided yet whether to remove the drug from the Register of Medicines, seeing as there are risks of court action.
Rigvir representative Kristīne Jučkoviča said the company takes full responsibility. "It's fully our responsibility...Any manufacture process has deviations from the previously set specifications. It's not unique to us. It is this way for many manufacturers," she said.
The company told Latvian Television that it still expects info on the methodology used by the UK lab which tested the samples. The company has asked to lift the ban on Rigvir sales but this request was ignored.
The Latvian Oncology Center in Rīga has hitherto treated melanoma patients with Rigvir. Doctors are evasive on whether melanoma treatments could be stopped, while the center's spokesperson said that currently there are no alternative medicines to treat the early stages of melanoma.
In what could be the most serious blow for Rigvir yet, there is risk of criminal liability for possibly having misled the patients, who are now in the worrisome situation of possibly having been treated with sub-par medicines.
Medical rights expert and lawyer Solvita Olsena invited patients to turn to the police, asking to check whether their Rigvir is what it says it is on the label.
She also said that the patients have the right to demand uninterrupted treatment that can fight cancer.
"It's the state's obligation to take care that there is medicine and that it is based in medicine, medicinally proven and effective. There is a rather high possibility here that there could have been negligence or erroneous actions on the part of different persons," she said.
Meanwhile ZVA reps, probed as to whether the institution is not responsible for the situation, said there had not been enough evidence to stop Rigvir sales before.
Last year the state contributed around 240,000 euros towards the costs of patients undergoing treatment with Rigvir; this comes to about €2 million since 2011 when it was introduced into the list of compensated medicines.
In an April 3 post on that appears on medicine.lv, neurosurgeon Renārs Putniņš joined the growing ranks of doctors to condemn Rigvir, calling the entire Rigvir ordeal an affair and asked for an investigation as to how the medicine could have been registered in the first place.
"There should be someone on the seat of the accused, at the very least, so that we don't have to experience similar situations in the future!" he wrote.
Atkārtotajās pārbaudēs konstatēts - "Rigvir" esošā aktīvā viela cīņai ar vēzi šķidrumā ir mazākā apjomā, nekā apsolījis ražotājs. Pacientu tiesību eksperte aicina “Rigvir” lietojušus pacientus vērsties policijā, aicinot analizēt viņiem izsniegtās zāles. https://t.co/aNWBtdlgnZ pic.twitter.com/0fJ8qsHBx0— LTV Panorama (@ltvpanorama) April 2, 2019