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Roll-Out Of New TB Drug Must Be Handled With Care



June 13th, 2014

Janssen Pharmaceuticals, a subsidiary of Johnson and Johnson, has announced that it will make its breakthrough new tuberculosis (TB) drug, Sirturo, available at a discount in 130 developing countries. As the first new antibiotic to be approved to treat TB in over 40 years, Sirturo will be an important new weapon in the aging arsenal of medicines used to treat this deadly disease.

Sirturo’s approval was a breakthrough for global health and TB treatment. In 2012, the airborne disease killed about 1.3 million people, making it second only to HIV/AIDS in the ranks of infectious killers. While the number of people dying from TB each year is slowly falling, drug-resistant strains are proliferating. According to the World Health Organization, ninety two countries have reported cases of extensively drug resistant TB since it was first reported in 2006.

Tuberculosis Treatment Programs

Now that Sirturo is ready for prime time – and poised for international distribution – it’s critical that the roll-out is meticulously managed by health care systems in each and every country that plans to administer it. TB drug resistance usually arises from poorly managed tuberculosis treatment programs. Treatment is long – about six months for basic treatment, and up to two years for drug-resistant strains – and only adds to the challenge of successful treatment completion. With improper or inadequate treatment, virulent new forms can evolve.

All of this is to say that if the introduction of Sirturo is mismanaged from a public health perspective, the process could quickly breed new, resistant TB strains that can outwit the drug.

This would not only be devastating to individuals who are affected; it could also introduce new public health risks with potentially global ramifications, as TB strains resistant to yet another drug take hold and spread. It would also undermine Janssen’s investment in developing the drug, which could create disincentives for future TB research and development investments in the private sector.

Rolling out a new antibiotic is a complex process that requires coordination among an array of actors, including physicians, public health administrators, supply chain managers, quality control agents, and insurance providers, among others. Above all, physicians must be adequately trained to prescribe and administer Sirturo as directed. This is a huge concern in TB hot spots like India. In Mumbai, for example, where people have been diagnosed with TB that is resistant to every locally available antibiotic, a study found that of 106 physicians asked to write a prescription for TB, only six were able to write a correct one.

Fortunately, Johnson and Johnson’s worldwide chairman of pharmaceuticals, Dr. Paul Stoffels, was quoted by Bloomberg News as saying, “This drug is absolutely not intended for widespread use. It’s all about getting the right combinations to the right patients in an expedited way so they don’t have to wait for many years.” In other words, they understand that introducing this new drug is complicated business.

How to Change TB Treatment

Yet countries that will receive Sirturo at a discount have some of the weakest health care systems in the world. It’s a positive sign that Janssen will be working with the Global Drug Facility (GDF), an international agency administered by the Stop TB Partnership in Geneva, to distribute the drug. This facility provides reliable shipments of quality-assured TB medicines to low-income countries. But the GDF has neither the mandate nor the capacity to manage the full integration of a new drug into national health care systems. This responsibility will ultimately fall on local actors in countries receiving the drug.

Research has shown that when changes in TB treatment have occurred in the past such as when recommended dosages of drugs have changed based on new evidence, countries with high TB rates have taken, on average, about a year to figure out how to execute the change, and then another two years to effectively implement it. Typically, mismanagement has been exposed only after implementation was underway. Best practices for rolling out the new drug would therefore call for the early involvement of decision-makers responsible for budgeting, procurement, regulation and manufacturing – and incorporating robust input from people who are, themselves, affected by TB.

Sirturo’s availability in developing countries is an important advancement in the fight against one of the world’s most deadly illnesses. But to ensure that the drug is put to effective use and does not contribute to further drug resistance, we must strengthen the capacity of local actors within countries to manage its roll out. The introduction of antiretroviral therapy to treat HIV in both low- and middle-income countries, which required simultaneously building the capacity of local actors to manage treatment programs, could provide some useful lessons. Otherwise, we risk turning what should be a victory into a failure for public health.

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