Red tape delays kids' TB pill
Strict regulations imposed by the health authorities are likely to delay the arrival of a new tuberculosis drug for children.
The first fruit-flavoured pill for TB was created in response to a lack of medication specifically for children.
Sick children have to use adult medicines. The various pills have to be cut to a size suitable for a child and are to be taken every day for six months.
This makes compliance with the treatment difficult and therefore increases the likelihood that children will die from this curable disease.
The new pill combines the three existing drugs prescribed for children but they are formulated into a single pill that can be dissolved in a flavoured drink.
"A single [daily] pill will make compliance and cure much more likely," said the head of TB Alliance, Mel Spigelman.
TB has killed more people worldwide than any other infectious disease but the development of treatments has long been neglected. Few new drugs have been released in the past 50 years.
Yesterday, the TB Alliance announced at the Union Lung Health Conference, in Cape Town, that a drug tailored for children with TB had been created.
South Africa has one of the highest incidences of TB in children in the world.
"But it won't be [in South Africa] in a few months. It looks like it will be longer than that.
"South African law requires that even if drugs are tested and recommended by the World Health Organisation they must nevertheless be [tested here]."
A clinical trial would be lengthy and expensive.
The new pill would be a godsend for people such as Cape Town mother Monique Davids. Two of her four children contracted TB.
She is required to take the children to a clinic daily to ensure that they receive the correct type and dosage of TB medication.
She struggled to get her young children to take the vile-tasting medicine.
Nurses would give her daughter money (R1 or R3) in an attempt to entice her to take the medicine.
"Caring for both children meant I lost my job," she said.
Head of Peadiatric programmes Cherise Scott said that NGOs Unitaid and USAid had funded the development of the pill and pushed for manufacturers to create it.
This was "after WHO said in 2010 that children needed their own medicine and no industry stepped up to the plate".
Now that the drug was available, she said, "countries must register and use these products immediately".
Doctors Without Borders spokesman Julia Hill said: "The world has been waiting for more than five years for a fixed-dose combination to be developed for children with TB, and Doctors Without Borders is preparing to use this new combination in its operations in the near future.
The pill uses the same drugs already recommended for children by the World Health Organisation, but simplifies treatment by putting multiple drugs into a single pill.
It is imperative that regulatory bodies like the Medicines Control Council do not cause unnecessary delays in registering this new combination, and instead allow rapid access so that use of the pill can be implemented as soon as possible in South Africa, and other countries in the region that look to MCC approvals for guidance.”
The Medicines Control Council declined to comment.