Another consignment of controversial Russian cancer drug Trastuzumab to be imported

....lowest bidder elbowed out -Concerns of Consultant Oncologists disregarded

by SURESH PERERA-October 14, 2017, 

A move to procure another consignment of 2,500 vials of the controversial Russian-made oncology (cancer) drug Trastuzumab (Herticad) at a staggering cost of over Rs. 360 million, despite a competitor offering a more competitive price for a time-tested, FDA (Food & Drug Administration of USA) approved product, has triggered shock waves through medical circles.

Despite the Sri Lanka College of Oncologists (SLCO) warning that the Russian-made Trastuzumab biosimilar (a biologic medical product, which is almost an identical copy of an original product manufactured by a different company) has "only been tested on around 100 incurable metastatic breast cancer patients" (and not tested on adjuvant use on early breast cancer patients), the green light has already been given to purchase another substantial stock, medical sources said.

"The move to purchase another 2,500 vials of a product, which has generated much controversy over "efficacy and safety concerns" is beyond belief", industry officials noted.

While the competitor has offered to supply the Trastuzumab biosimilar (CANMAB 400) at the rate of Rs. 97,700/- per vial, the Russian product is being procured at Rs. 144,100/- per vial, they asserted.

The total cost to procure the Russian product works out to over Rs. 360 million, while the competitor has offered the stock for Rs. 244 million – a saving of Rs. 116 million as the difference in the price per vial is Rs. 50,000/-, they said.

Another registered party has also made a bid for Rs. 98,000 per vial, but quite strangely, the tender was awarded to the highest bidder instead of the lowest despite a hefty price difference, the officials aid.

This translates into the government paying more to procure the consignment at a higher price, which not only means a loss of Rs. 116 million, but also that another substantial stock of a product that has come under flak from oncologists, is being imported at enormous cost in lieu of an FDA approved drug accepted and administered world-wide, they pointed out.

Responding to a letter written to all hospital directors by the MSD (Medical Supplies Division) director, SLCO’s president, Dr. Damayanthi Pieris, and secretary Dr. Sujeeva Weerasinghe, says in a reply dated October 9, 2017, that the "performance of Biocad Trastuzumab (the Russian made drug) is adjudged by the overall survival in metastatic breast cancer patients and disease-free survival in early breast cancer patients. These parameters have to be calculated by analyzing all patient data collected systematically and comparing them with data of patients who received the reference drug.

"Data need to be collected over an adequate length of time for a statistically significant analysis of given end points. Without collected data related to all patients who received this drug and analyzing them correctly, it is not possible to find out the performance of the medicine. Therefore, we cannot comment on the efficacy/performance of this drug".

In an earlier letter dated September 18, 2016 addressed to the secretary of the Health Ministry, Dr. Pieris has noted that "recently a Russian made Trastuzumab biosimilar has been registered in Sri Lanka. The product has only been tested on around 100 incurable metastatic breast cancer patients. It has not been tested on adjuvant use on early breast cancer patients.

"Therefore, SLCO recommends that HER 2 positive early breast cancer patients should not be given this untested drug lacking evidence of efficacy and long tern safety. We recommend that this biosimilar be used only on metastatic setting with strict surveillance on efficacy and adverse reactions. We believe that the already purchased stocks will be adequate for metastatic patients, which form only a minority of patients needing this drug".

Who gave the go-ahead to import another consignment when even Consultant Oncologists, the final authority on the subject, have clearly stated that they cannot express an opinion on the efficacy/performance of a product, which remains largely untested as its use is still restricted to Russia and a handful of other countries in that region?, health officials queried.

Moreover, the SLCO has indicated that the "already purchased stocks will be adequate for metastatic patients, which form only a minority of patients needing this drug". Under these circumstances, what was the urgent necessity to import another 2,500 vials of this drug which, in any case, is being used only on few patients?, they asked.

"Oncologists currently use several other biotherapeutic products which have fulfilled the criteria on efficacy and safety. We fully support the government efforts for cost effective strategies on cancer treatment. However, the cornerstone for any such strategy should be on solid clinical evidence and patient safety", Dr. Peiris noted.

If the government is pursuing cost effective strategies on cancer treatment, how come the lowest bidder was ignored and the tender awarded for the Russian product at an additional cost of Rs. 166 million?, medical officials asked.

Somebody somewhere is apparently making a big kill on the bid, they asserted. "Otherwise, why opt for a higher price when a better, time-tested drug is on offer?"

The Sunday Island learns that a top Health Ministry official had recommended against importing more stocks of the Russian product, which has run into controversy over efficacy and safety concerns.

However, his objections have been overruled and a purchase order placed on October 3, 2017 with the local supplier for another 2,500 vials at a cost of Rs. 360,250,000.

Repeated attempts to contact Health Ministry Secretary, Janaka Sugathadasa were futile as he was "at meetings" all day long on Friday. His secretary promised that he would return the call for comment, but he didn’t. His mobile phone also went unanswered yesterday.

The Sunday Island was asked by the secretary’s office to contact MSD Director, Dr. Lal Panapitiya, but his mobile phone initially rang but was not answered. It was later switched off.

A senior health official, however, said the bid for the second consignment of the Russian-made drug was awarded on an earlier Cabinet decision to import 5,000 vials in two stages.

"This is bunkum", industry officials protested, referring to a document sent by the Health Ministry on August 22, 2016, which stated that the "Standing Cabinet appointed Procurement Committee recommended to award initially only 50% of the tender to the lowest responsive bidder".

This meant that the first consignment of 2,500 vials imported at a cost of over Rs. 360 million earlier encompassed the 50% referred to in relation to Cabinet approval granted for this purpose. No such approval was given for the balance 50% as clearly indicated by the Ministry, they pointed out.

Even if there was approval and if the country was saving Rs. 116 million by purchasing a more reliable, time-tested drug for the benefit of patients, surely it wouldn’t need an Albert Einstein to figure out what needs to be done, the officials said.

Panjandrums in the health sector will naturally duck discussing this ‘sensitive’ issue with the media, they laughed, and added "the political implications involved could leave them out in the cold".