The Health Ministry is to implement two urgent measures next week to overcome a dispute pertaining to a life-prolonging cancer drug, officials said. The issue is over Pacliall, an apparently cheaper drug newly-registered, allegedly without proper evaluation, cancer specialists say. Abraxane, the original drug, is the one that has been in use here for this [...]

 

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Dispute over non-evaluation of new and cheaper drug to fight cancer

Traditional drug to be used till new one is examined
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The Health Ministry is to implement two urgent measures next week to overcome a dispute pertaining to a life-prolonging cancer drug, officials said.

The issue is over Pacliall, an apparently cheaper drug newly-registered, allegedly without proper evaluation, cancer specialists say. Abraxane, the original drug, is the one that has been in use here for this treatment.

Both drugs were submitted for a new tender recently and the issue had arisen when there were allegations of non-evaluation of the latest drug. It was at this point that the ministry stepped in.

In a temporary solution to the crisis, a limited quantity of Abraxane is to be approved by Health Secretary Dr. Nihal Jayathilaka, based on the urgent requirements of patients to be submitted by the Director-General of Health Services Dr. Palitha Mahipala, in a report tomorrow.

Simultaneously a Committee comprising Oncologists, Pharmacologists and Health Ministry officials will be appointed to evaluate the cheaper drug and the issues that have been raised, and reach a decision. While there are other drugs in the market to treat cancer patients, Abraxane is specially-designed to treat the more seriously-ill patients and prolong their lives, and has been supplied free to around 50 under a Government-funded scheme.

Dr. Jayathilaka, when contacted by the Sunday Times, said the two new measures will take effect together, explaining that it is the result of intensive discussions with the involvement of Health Minister Maithripala Sirisena.
These moves came as several patients that the Sunday Times spoke to pleaded with the authorities to make the required drugs available to them.
A 46-year-old cancer victim in the suburbs of Colombo was in church, when the Sunday Times met her on Friday. Surviving breast cancer in 2007, with the precious little family savings being channelled to fight the disease, this mother of three, has now been affected by lung cancer.

“I just want to see my daughter married. I know I have to die someday, but I need a little time,” she says weeping. Her daughter is 22 years old and her youngest son only nine years old.

Every day around 2 p.m. after her two sons get back from school, she is at church, praying that there would be succour for her plight. Now the earnest prayer is for the medication to be brought to the country quickly by the health authorities.

This is the same tale of anguish that the Sunday Times heard from a few more patients in telephone interviews.

Oncologists (cancer specialists) have levelled strong allegations at the Cosmetics, Devices and Drugs Regulatory Authority (CDDRA) of fast-tracking the registration of the new drug in November last year without proper evaluation .

CDDRA Director Dr. Hemantha Beneragama was unavailable for comment as he is abroad and due back tomorrow.

College of Oncologists President Dr. Mahendra Perera said this particular cancer drug is administered to very-ill patients especially those suffering from fatal lung or pancreatic cancers or advanced breast cancer.

Questioning the evaluation of the newly-registered drug, he said Oncologists have sent it for analysis. There are certain criteria that need to be followed when registering a drug and these cannot be overlooked in fast-tracking, he said.

He also questioned why the end-prescribers who are the Oncologists were not consulted by the CDDRA.

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