Oncologists refuse to use new controversial Russian cancer drug

Imported at a cost of over Rs. 300mn but questions over safety and efficacy

by Suresh Perera-August 6, 2016,

A new Russian drug procured by the government to treat patients with breast cancer has run into a storm with oncologists declining to use, what was termed a "nondescript product with questions lingering over its safety and efficacy".

While health officials defended the purchase of the controversial oncology medicine ‘Herticad’ saying it is "cost effective", medical sources lashed out at the move, asserting that even the basic condition that a biosimilar (A drug designed to have active properties similar to one that has previously been licensed) should be administered on patients in the country of origin for two years had been violated.

This drug was launched in Russia in January 2016 and a tender to import the medicine to Sri Lanka was submitted by a local supplier the following month itself, they said.

The go-ahead to procure the product with neither referrals of the drug’s experience in other countries nor proper evaluation with clinical references and trials, the sources claimed. "The use of this medicinal drug is at present confined to just three countries — Russia, Belarus and Ukraine".

"There are some mandatory stipulations when procuring drugs for cancer patients, but how come a product not even effectively tried and tested for two years in the home country was allowed to be imported?", they queried.

The approval of pharmacologists alone won’t suffice for life-saving critical oncology drugs as clinicians should give the green light for their use on patients, the sources pointed out.

Despite the Health Ministry procuring a sizable consignment at a cost of more than Rs. 300 million, most of the oncologists of the Maharagama Cancer Institute (MCI) have refused to administer ‘Herticad’ to patients.

"This drug was not referred to the College of Oncologists for approval", says Dr. Mahendra Perera, a top medical specialist in the field. He was the Past President of the College.

He said that this Russian product gives a different indication as it is meant to be administered to patients in an advanced stage of breast cancer. "It is not the right indication as there are no proven benefits after the cancer spreads".

That was why the College of Oncologists decided against using it. The majority of oncologists at the MCI also refrain from administering the drug, and those who do so should bear the responsibility for a situation that arises, Perera explained.

The worthwhile concept is to administer drugs before breast cancer spreads, monitor the response and offer relief to symptoms for survival benefit, the veteran oncologist noted.

"What is the use of bringing down medicines worth millions of rupees to treat an aggravated stage when safety profiles don’t come into play as patients in any case die of the disease?", he asked.

Another medical official warned that the possibility of the drug leading to toxicity which could affect the heart of patients has not been ruled out. "We need to get a feedback on the side-effects from patients".

The product registered in Russia has been tested on women in the last stages of breast cancer. Under these circumstances, there was no evidence to ascertain whether it could be used to prevent the cancer from recurring or spreading, he said.

Oncologists had not been consulted, and despite opposition by experts in this field serving on the Technical Evaluation Committee, the controversial product was imported, he noted.

"We have procured this Russian biosimilar at Rs. 66,000 per vial, which was a big saving in comparison to other products", the health official said.

This is absolutely bunkum, industry players shot back. "A total of four different consignments of 1,205 vials were procured at quoted prices ranging from Rs. 165,000 to Rs. 198,000 each, with 49 vials free of charge in one lot and a 20% concession per vial for the others", industry players asserted.

There are some doctors eager to see the ‘medical mafia’ monopoly continue as they enjoy undue benefits from certain pharmaceutical companies, the health official charged.

It is an open secret in the trade that, apart from the luxury trip to Russia offered to an influential individual, certain parties are attempting to give "incentives" to doctors who use this drug as stocks are virtually stagnant with oncologists declining to use them on patients, the industry players alleged. "This has spurred one doctor to use 100 vials so far at a key cancer facility".

"We have discovered that certain drugs which cost US$ 3 dollars had been supplied at US$ 30", the official said.

If that was so, it shows there had been no proper evaluation of the bids by the authorities. All these lop-sided claims pale into insignificance when taking into account how more than Rs. 300 million has been virtually busted on useless cancer drugs, which oncologists have rejected, the industry players said.