[e-drug] Therapy flaw lets loose TB carriers in India

E-DRUG: Therapy flaw lets loose TB carriers in India
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Misleading treatment policies have created TB resitence in Indian DOTS programme.
http://www.telegraphindia.com/1081222/jsp/frontpage/story_10286001.jsp#

Issue Date: Monday , December 22 , 2008

Therapy flaw lets loose TB carriers
G.S. MUDUR

New Delhi, Dec. 21: India’s tuberculosis control programme is aggravating the disease in thousands of patients each year through a plan of treatment that threatens even uninfected people with drug-resistant TB. Statistics covering the past three years of the programme reveal that among 53,500 patients who received the regimen, at least 4,469 have died and over 7,200 have not been cured.

Medical experts have described the treatment plan practised by the government as unethical. They say it ignores the needs of individual patients and contributes to the spread of multi-drug resistant TB (MDR TB), which is harder to cure and more expensive to treat.

The debate centres on “re-treatment”: how to manage patients who do not respond to a combination of four drugs — the first line of therapy against TB. The government’s re-treatment plan involves adding a single drug — streptomycin — to the same four drugs.

Programme critics say this violates a sacrosanct rule in TB treatment — not to add a single drug to patients who have not responded to therapy. “This is exactly what the programme has been doing for years,” said Anurag Bhargava, a doctor at a rural health clinic near Bilaspur, Chhattisgarh.

“This therapy amplifies resistance and is an unethical waste of resources,” said Zarir Udwadia, a chest physician at Mumbai’s Hinduja Hospital who says he has seen patients with MDR TB after they received the re-treatment regimen. “Patients who do not respond to this flawed re-treatment are walking reservoirs of MDR TB, a potential threat to everyone around them,” said Bhargava.

Despite mounting evidence of problems with the re-treatment regimen, health officials have insisted for years that it is an appropriate therapy since it is based on the World Health Organisation’s TB treatment guidelines.

But the first signal that all was not well emerged in a study by WHO experts eight years ago. In October this year, Indian health ministry officials quietly revised their policy on re-treatment — without the means to make it effective on the ground.

Health officials, requesting anonymity, have claimed that concerns over re-treatment have been blown out of proportion. They said the 11-year-old TB control programme had a treatment success rate of 85 per cent and had saved nearly 1.8 million lives. The programme assures free drugs to every patient diagnosed with TB — over a million a year — in a country where health projects have often found themselves bereft of medicines, they said.
But Carole Mitnick, a public health specialist at Harvard Medical School in Boston, told The Telegraph: “Adding streptomycin to the first set of drugs universally to all patients who failed the (first) therapy is dangerous policy.”

Experts have urged a different strategy — isolating TB bacilli from patients not cured by the first line of therapy, studying the germs to find out which drug combination works best, and tailoring individualised therapy for each patient. Such drug susceptibility tests are performed routinely in the US and Europe, even for first-time TB patients. “This is the gold standard,” Mitnick said.

But health officials said the initial effort of the TB programme was to expand so that patients across India could receive free first-line therapy. “Drug susceptibility testing was not a priority,” an official said. “The (TB control) programme is evolving. We’re now offering drug susceptibility tests at 10 centres to patients not cured by an earlier therapy. We will have 35 centres and cover the country by 2012,” the official said. But critics warn the move is too little, too slow.
“The government has ignored the danger of MDR TB too long,” said Bhargava. Programme figures suggest MDR TB affects 15,000-30,000 new patients in India each year, he said.

Health officials concede India lacks the laboratory infrastructure to provide drug susceptibility testing to all patients with failed therapy. “It will take time to implement a new policy for such a large country,” an official said. “All these years, they defended the re-treatment plan. Now they’ve quietly revised it without the infrastructure to implement it,” Bhargava said. “We’ll continue to see the human cost.”
TB control programme statistics show that about 60 per cent of patients retreated after failure of the first therapy are cured despite eight months of retreatment. “For other diseases,” said Mitnick, “most public health specialists would not be satisfied with a therapy that takes eight months and cures just over half those afflicted.”

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