JO demands probe on controversial Russian-made Trastuzumab cancer drug procurements

Complains to Bribery Commission and CID against Health Minister


JO parliamentarians Ranjith Soysa, Attorney-at-law Sisira Jayakody, and Sanath Nishantha returning after complaining to the CID last week. (Pic by Kamal Bogoda)



The procurement of a controversial Russian-made Trastuzumab biosimilar to treat patients with metastatic (spread) breast cancer figured in last week’s complaint the Joint Opposition lodged with the Bribery Commission and CID against the backdrop of consultant clinical oncologists frowning on administering a "nondescript drug with questions lingering over its safety and efficacy", industry officials said.

A biosimilar is a drug designed to have active properties similar to one that has previously been licensed, but the purchase of this product by the health ministry last year ran into a storm over assertions that it had violated even the basic condition that medicines in this hyper-sensitive segment should be administered on patients in the country of reference for at least two years.

In August 2016, The Sunday Island exclusively reported the controversy over the procurement of this new product, in a story under the headline "Oncologists refuse to use new controversial Russian cancer drug: Imported at a cost of over Rs. 300mn but questions over safety and efficacy".

The Joint Opposition (JO) complained against health minister, Dr. Rajitha Senaratne, alleging that substantial stocks of "unsuitable Russian-made cancer drugs" had been imported at a cost of Rs. 1.5 billion without consulting the Sri Lanka College of Oncologists, the top professional body in this specialized sphere.

JO members also charged that despite medical specialists declaring these drugs "unsuitable" for cancer patients, tenders continue to be awarded to import these injections.

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, industry officials said.

The green light to procure the product was given with neither referrals of the drug’s experience in other countries nor proper evaluation with clinical references and trials, they asserted. "The use of this medicinal drug is at present confined to just three countries — Russia, Belarus and Ukraine".

Bevacizumab, another generic biosimilar imported by the same supplier from Russia, has also run into a storm over allegations that the product had also not been tested for the defined two-year period in the country of reference. The drug is an oncology medicine that interferes with the growth and spread of cancer cells in the body.

Notwithstanding apprehensions expressed by consultant clinical oncologists on the safety and efficacy of the drugs, the health ministry has procured stocks worth around Rs. 1.5 billion (2016 May-December 1,982 vials, 2017 January-February 818 vials, with an order for 157 more being processed), industry officials claimed.

The health ministry’s contention is that procuring Russian biosimilar products is cost effective and translates into a big saving at the end of the day in comparison to other products, but industry players dismissed this claim saying that vials were procured at quoted prices ranging from Rs. 165,000 to Rs. 198,000 each, with some concessions by way of free vials and a discount granted depending on the size of the consignments.

There were four or five other suppliers who could have offered more competitive pricing with some drugs widely used in the US and Europe, but not everybody is fortunate with registering their products, they pointed out. "It’s a simple formula for a one horse race – no registration, no bidding".

As consultant clinical oncologists initially declined to administer Trastuzumab, describing it as an "untested drug lacking evidence of efficacy and long-term safety", the health ministry warned of disciplinary action against cancer specialists of government medical facilities who refuse to use these injections on patients.

In some cases, specialists obtain the written consent of the next-of-kin of patients before administering the medicines due to what was described as a "lack of confidence on the drugs". This was understandable as they could be held responsible for the loss of any lives, officials pointed out.

In September 2016, the health ministry demanded the explanation of a top consultant oncologist for expressing adverse views to a newspaper on the RussianTrastuzumab biosimilar, on the grounds that a government medical specialist cannot interact with the media without due approval from the ministry".

In fact, the Sri Lanka College of Oncologists (SLCO) wrote to the health ministry secretary in September 16, 2016, pointing out that the "Russian-made Trastuzumab registered in Sri Lanka has only been tested on around 100 incurable metastatic breast cancer patients. It has not been tested on adjuvant use 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 term safety. We recommend that this particular 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 the metastatic patients which form only a minority of patients needing this drug", the letter signed by SLCO president, Dr. Damayanthi Pieris, noted.

It added that "oncologists currently use several other biotherapeutic products such as Rituximab, GCSF, which have fulfilled the criteria on efficacy and safety. We fully support 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".

The letter was accompanied by a list containing signatures of 25 practicing consultant clinical oncologists in the country, who have "agreed" with the position taken by the SLCO.

In another communication in December 2016, SLCO has rejected the secretary’s statement that SLCO’s position is irrational and unscientific, and observed that the NMRA (National Medicines Regulatory Authority) has failed to properly adhere to the WHO and EMA guidelines.

SLCO strongly urged the secretary to formulate an independent panel of experts including cancer specialists, specialists from other clinical fields, immunologists and pharmacologists to examine each concern it (SLCO) has raised on extrapolation as a matter of urgency.

"We believe that our position on clinical safety of cancer patients should be respected as experts on oncology in Sri Lanka. It is our duty to warn that due to non-availability of Herceptin at present, the fatal consequences, especially breast cancer recurrences, will only manifest in coming years. Unfortunately, it will be too late for the poor cancer patients affected. The favorable breast cancer survival rate achieved over the years in Sri Lanka, which is even better than countries like Russia, will also be in danger of decline", the SLCO communication warned.

Health Secretary, Anura Jayawickrema said that oncologists continued to use the Russian-manufactured Trastuzumab on cancer patients and there was no issue with the quality of this drug.

"Procuring this biosimilar from Russia has translated into a big saving for the government and its entry into the market has spurred some companies to reduce the prices of their products", he told The Sunday Island.

"This shows the unconscionable profits these importers, including multinational companies, make on oncology drugs", he noted.

"We have not received any negative feedback on the use of this Russian-made drug so far", he said.

Asked about concerns voiced by the Sri Lanka College of Oncologists, Jayawickrema replied "We have oncologists and not accountants or SLAS members on our medical boards, and they have recommended this drug. This shows that there is no problem with its use on cancer patients".

"Just as much as pricing is a key factor, isn’t the safety profile of the drug more important in terms of saving lives of patients? Surely pricing cannot be allowed to override safety and efficacy", an oncologist observed.

On the other hand, if the ministry is so concerned about the "right pricing", why are other competitors who can offer more competitive rates being elbowed out through non-registration of their products?, he asked. "The call for a balanced panel to evaluate the clinical and pharmacological aspects of the Russian drug has so far been ignored".

Citing the case of ‘Mylan’, an oncology drug registered in Europe, and widely in use in the US and India and also approved by the SLCO, he asserted that the product’s registration remains blocked, while, of a bid to supply 5,000 more vials of the "untested" Russian-made Trastuzumab biosimilar, the green light to import a stock of 2,500 was given last week.

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