Linezolid: Affordable generic access win highlights obstacles to life-saving treatment

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With side effects that include stomach pain, vision problems, vomiting, diarrhea,  and anemia as well as pain, weakness, and numbness in hands and feet, linezolid is not something you would take if you had much choice.

But for patients in Khayelishta, a township in South Africa’s Western Cape where rates of poverty, HIV and tuberculosis are high, the drug has been a luxury. Found in a 2009-published study to be an effective addition to treatment for both multidrug-resistant and extensively drug resistant tuberculosis, it has been a lifesaver, giving patients a chance to survive when other medicines didn’t work. Since 2011 the World Health Organization has included it among recommended drugs for treatment of drug-resistant tuberculosis. Still, in all the years since the drug’s potential was noted, the opportunity to be cured from, to cease to transmit, and survive difficult to treat strains of tuberculosis remained out the reach of many because at about $65 per pill, a course of treatment cost nearly $50,000. A generic version of the medicine was available in other countries for about $8 a pill, but not in South Africa where rates of drug-resistant TB are among the highest in the world.

That changed last week when the South African Medicines Control Council gave Médecins Sans Frontières approval to bring in the less expensive version, expanding access to the drug. The decision capped a three-year process, during which MSF appealed the council’s earlier refusal to approve import of the generic medicine, and during which, according to MSF, the price of the patented brand name medicine from Pfizer pharmaceutical company used up to 10 percent of the nonprofit health organization’s entire annual budget for HIV and TB programs in Khayelishta, and access to the drug was limited. In the meantime, the MSF announcement says, patients died waiting.

The exception made by the South African body is a precedent, presently limited to Khayelishta, and comes at what health care access advocates hope is near the end of a six-year process to reform South Africa’s patent laws. The reform would, if responsive to advocates input, limit patent monopolies and make generic affordable medicines accessible sooner. That process, however, as noted here, has been targeted by a proposed campaign from U.S.-based pharmaceutical and public relations firms to stress the dangers of rushing into a new policy, and to “slow down.”

MSF has produced a fact sheet with more information about linezolid, including a timeline of MSF’s efforts to get the drugmaker to lower its price and to get the generic drug into South Africa.

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