Friday, January 06, 2017

`Patient Can Procure TB Drug Under Compassionate Grounds'


LRS CASE Hospital following protocol on conditional access to bedaquiline, govt counsel tells court
Patients with extensively drug-resistant tuberculosis (XDR TB) can separately import the potentially life-saving `bedaquiline' if they don't qualify for the drug under India's conditional access programme with US drugmaker Johnson & Johnson, the government has said.
The issue was brought up on Monday when an XDR TB patient's father took New Delhi's LRS TB hospital to the Delhi High Court for refusing to administer bedaquiline because the patient was not a Delhi resident.
The patient, who is from Bihar, is not under LRS' care anymore, argued the counsel for the hospital at the Delhi court. The counsel said the patient could procure the bedaquiline directly from J&J with the help of Zarir F Udwadia, a Mumbai-based consultant chest physician who recommended its use.
LRS is not in a position to follow the line of treatment suggested by Udwadia, the counsel said. The hospital also doesn't have the equipment required to conduct the pyrosequencing test sought by the patient's father, Kaushal Kumar Tripathi, LRS' counsel told the court.
“We will not be able to do it (provide bedaquiline) because we are sticking to the protocol that is prescribed,“ said the hospital's counsel. “If Dr Udwadia wants to continue the treatment, then he may try to get the bedaquiline under compassionate grounds....“ However, according to Dr Udwadia, it takes around 45 days for the drug to reach patients if they apply under compassionate use. “This convoluted and hectic procedure facilitated disbursement of only 56 therapies of bedaquiline in India from January 2013 to September 2015 when the company suspended its global compassionate use programme,“ he told ET.
Janssen, the J&J subsidiary which manufactures the drug, said it continues to provide the compassionate use programme in India, but said it cannot comment on how the government's conditional access programme is working.
“Since 2013, we have received 88 applications in India for compassionate access to bedaquiline, from public and private sector physici ans and hospitals across the country. Based on inclusion and exclusion criteria as per our global medical guidelines and aligned with the WHORNTCP criteria for use of bedaquiline, 65 patients have been approved for access under the compassionate use programme,“ a Jansen spokesperson told ET.
One of the reasons for the controlled access to these new TB drugs in the government centres offering them is because of logistical issues, the government said.
“The six centres providing bedaquiline under the Conditional Access Programme are the only ones equipped and trained to manage the programme so far,“ Sunil Khaparde, Deputy Director General-TB of the government's Central TB Division, told ET. “Patients need to be constantly monitored, which is why these centres are currently administering the drug only to residents of these six states,“ he said So far, the government has procured 300 doses of bedaquiline from J&J, of which it has administered nearly 200 doses, Khaparde told ET. Justice Sanjeev Sachdeva is expected to hear the case next on Wednesday.
ET VIEW:
Increase Availability
The government must make procedures to procure and distribute TB drugs simple and easy. Non-availability of TB drugs, be it through private clinics or governmentfunded health care centres, is detrimental to patients, results in complications and proliferation of drug resistant strains of TB. The human and economic cost of not simplifying the sourcing of TB drugs is far too high. The government must take steps to remedy the situation.

Source: THE ECONOMIC TIMES-4th January,2017