The Sunday Leader

Cancer Drug Causing A World Of Pain

by Camelia Nathaniel

Maharagama Cancer Hospital

Controversy continues over the cancer drug ‘pegaspargase’ with doctors refusing to prescribe it and oncologists saying that most likely the drug will be kept at the hospital until it expires, so that nobody is held responsible for it. The Chinese drug is imported by Medmart Pharma (Pvt) Limited, the marketing arm of Omax Healthcare (Pvt) Limited. According to doctors at the Maharagama Cancer Hospital, everyone has been requested not to issue the drug.

Speaking to The Sunday Leader, a very senior member of Sri Lanka College of Oncologists said health authorities had informed the hospital to keep the stock of pegaspargase. He condemned the importing and dumping some unknown drug to be tested on cancer patients without the consent of the members of the College.

“We have a panel of oncologists who look into the quality of the drugs, and we also have a representative of the College of Oncologists to the National Medicines Regulatory Authority (NMRA). None of these people had been consulted, and the authorities had just dumped it at the cancer hospital. All the doctors of the college agree that all drugs brought in without the appropriate analysis of the end-user (the doctor), will not be prescribed because there is a huge risk to the patient.”

Meanwhile, Professor Lal Jayakody, the Chairman of the National Medicinal Drugs Regulatory Authority (NMDRA), resigned and Professor Asitha de Silva took up that post.

Speaking to The Sunday Leader, the National Organiser of the Senaka Bibile Commemorative Association (SBCA), Dr. Jayantha Bandara, said that it was wrong of the authorities to make this appointment as it would be detrimental to the health sector.

“Since we know the connection of Prof. Asitha de Silva, we can take measures to prevent him being appointed. Another fact is that he has been appointed by removing an accountant from that post who is rightfully suitable for that post. We will file a case in court against the Health Minister because he has violated the terms of the National Medicines Regulatory Authority Act,” he added.

According to Dr. Bandara, Prof. Lal Jayakody, the Head of the Department of Pharmacology at Colombo University, and Prof. Krishantha Weerasuriya, the South Asian Drug Policy Advisor to the World Health Organisation, who were serving as the Chairman and Chief Executive Officer at the NMRA respectively were two eminent medical professionals, who were asked to step down by the Health Minister.

“He did it because these two medical professionals were a threat to multinational pharmaceutical companies, because they introduced new regulations to control the prices of medicines to benefit innocent patients. If we are to maintain a proper health service in this country, proper guidelines have to be followed.

WHO has listed these guidelines on how to develop and implement a drug policy, and many countries are already following these guidelines. WHO has also accepted the drug policy that Professor Senaka Bibile formulated. Prof. Krishantha Weerasuriya is also a member of the WHO committee and drug policy maker. There are about 50 members and Prof. Krishantha Weerasuriya is one of them. In order to uplift the health services of the country there must be proper policies in place.

But what has happened in our country is that all these drug companies have been allowed to do as they please because of the involvement of powerful or influential parties, and that is why the drug companies are manipulating the drug trade as they please,” he said. Meanwhile, a drug called Herceptin being used for breast cancer patients has been replaced with a Russian manufactured drug called ‘Trastuzumab’. A senior oncologist at the Maharagama Cancer hospital on condition of anonymity said that Herceptin is expensive but certain patients have to be given that drug.

“Even though it is expensive, we cannot deny the patient the treatment. Now someone has brought down the drug from Russia; it was registered in Russia only in January this year and by February-March they brought down this drug to Sri Lanka, and the NMRA has registered it without any evidence of its efficacy etc. The drugs are now available in Sri Lanka and a stock has already been sent to Jaffna.”

However, with the court injunction and the College of Oncologists refusing to use the Russian drug Trastuzumab, the Maharagama Cancer Hospital has suspended the administering of the Russian product.

“We have been using Herceptin, but we are not sure if this new drug has the same effect. We have informed our membership not to use the drug as we are uncertain of its efficacy. If it was tested properly, it could not have come to Sri Lanka just two months after it was registered in Russia. What we hear is that the NMRA had been asked to sign the document accepting this drug. Then Asitha de Silva had approved it and purchased it.” “Some people accuse the College of Oncology that they have asked for the more expensive drug.

They claim that we are being paid by Roche and that we are stopping this cheaper drug because of that and that we are going against the Senaka Bibile policy. They have tried to sling mud at the College. If anyone is to bring down a generic drug, the price should be 40 per cent of the cost of the original drug and that is the criteria. However in this instance, this costs around 80 per cent of the original drug,” explained the oncologist.

When The Sunday Leader contacted the spokesman for A. Baur & Co, authorised distributor for Herceptin in Sri Lanka, he said their parent company is headquartered in Basel, Switzerland, and it operates through the local distributor  – A. Baur & Co. The importing and distribution of their product is being handled by Baur.

 

Russian entry

Explaining the Russian entry into the market, he said that is non-comparable biological replicate; they are essentially is what is known as an originator product which has been manufactured by their company and has gone through clinical trials and review. However, they have filed a lawsuit seeking some clarification as to how this product from Russia has been approved in Sri Lanka.

“Essentially, the process is that the clinical trials go through several phases where key clinical studies are done on animals, and after that, it goes through various stages of clinical trials from phase 1-4. Essentially you have what is known as WHO guidelines for approving a biosimilar product. These guidelines are mentioned in the NMRA website and if a product is to be approved, they have to follow those guidelines. Any similar product has to meet those criteria. “We are now trying to seek clarification as to how this product was approved. That is pretty much the premise of this entire legal action,” he added. Cancer cells grow in an uncontrolled fashion. Herceptin works on the surface of the cancer cell by blocking the chemical signals that can stimulate this uncontrolled growth. Herceptin is an example of an immune targeted therapy. In addition to blocking HER2 receptors, Herceptin can also help fight breast cancer by alerting the immune system to destroy cancer cells onto which it is attached. This is a targeted therapy and a biological product.

Oncologists point out that patients taking this type of untested drugs are at risk.

“These are some of the concerns that we are trying to raise. Currently there is an injunction preventing the Medical Supplies Division from importing the product,” he said. A senior oncologist from the College of Oncology said none of their representatives at the NMRA had been consulted with regard to Herceptin.

“The irony is that there were other drugs of the same quality in the NMRA pending Health Ministry approval nearly a year, but those have been overlooked while the Russian brand Trastuzumab had been selected and approved. We will be taking a decision on this issue at our next AGM on the 25th of this month.”

He said that although they might be able to show some clinical trials, there is a stipulation that if you manufacture a drug in a particular country, you have to use that drug in that country for the period of the expiration of that drug. Only then can they register it in another country and those countries can use it if they wish to. In the case of this drug, it was sent to Sri Lanka only after a couple of months from manufacturing it.

“We have been accused of supporting the drug companies, but we were not supporting any drug company, and we don’t mind new drugs coming into the market as long as the proper procedure is followed, since it protects the patients. We suggest that they must purchase a small quantity of a new drug, and use it for around six months and then see its efficiency, review it and ensure that proper SAE forms are filled up etc. All this is done by the consultants,” he said and added that in this case the drugs have been bought, and the company has been paid huge amounts of money. “It looks like a business. It will not benefit the patients in anyway” he stressed.

4 Comments for “Cancer Drug Causing A World Of Pain”

  1. Justice

    It looks as if everything is in a mess and we do not knowp who is right and who is wrong-even there are accusations against the Health Minister,
    ALL THAT WE SUFFERING PATIENTS OF THIS COUNTRY KNOW IS THAT
    THE MUCH HYPED NATIONAL MEDICINAL DRUG POLICY OVER WHICH TWO INDIVIDUALS MAITHRIPALA SIRISENA AND RAJITHA SENARATNE WORKED HARD,, HAVE NOT BROUGHT ANY BENEFIT TO THE PEOPLE. On the
    contrary all prices of medicinal drugs and medical services have gone up
    beyond the reach of the average person

  2. Virginia Tilley

    This article is very confusing. Trastuzumab is just the generic name for Herceptin, as anyone can see with a short Google search. And Trastuzumab is NOT a new drug. It’s been around for a long time and it is a miracle treatment for a particular breast cancer type called HER2-positive, which about 20% of people with breast cancer have. The question of whether this new generic biosimilar Trastuzumab coming out of Russia, is properly made and as effective as it should be is very important. But I can’t tell from this article whether the issue is the quality of the Russian biosimilar or just some major confusion about what Herceptin and Trastuzumab are – that is, the same thing.

  3. daggy

    Its a right royal yahapalana mess.
    It appears some one is making a quick buck at the expense of the patients.

    This is yahapalanaya the masses voted for.

    We have for a Minister a foul mouthed mule who is playing politics with officials.

  4. Prasad

    A friendly advise to the writer of this article; Camelia Nathaniel.
    You should have done some background research about the topic before you publish. The article tries to make a big issue about nothing; you write about replacing a drug made by the original company with a variant (the same drug-different name only). This is legal (once the patent ends) and happens in all the countries all the time. What the drug companies do to counteract competitors producing the drug is to reduce the price (i.e. Pfizer reduced the price of Viagra to the same price of the generic, once the parent elapsed).

    I know Krishantha and Upali and they are really knowledgeable and competent people. They cannot be pointing out something trivial such as replacing a brand (the generic being the same). It should be something else that you failed to realise. May be they are concerned about the quality of the Russian variant. If that’s the case, you should write about the quality of the drug and whether it is similar to the original in the composition.

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