Michael Specter published an interesting article on TB in India, called: A Deadly Misdiagnosis, November 15, 2010. India is the largest country in the world by population, so it isn’t too surprising that it has a major TB problem, particularly with the country-wide exodus from rural to urban lifestyles.
India is also a country that has enjoyed over the last decade an average of 7-9% economic growth rate in GNP; is a major nuclear power with intercontinental launch capabilities; has the largest middle class in the world (some 325 million, or more than the entire population of the U.S); with thanks to the Green Revolution, it has moved from a net importer of food grains to a net exporter in less than a decade; is a global leader in Information Technology and Call Centers; and, is host to the largest influx of medical tourism in the world, spawning a multi-billion dollar industry, serving high-end foreign patients in five-star quality hospitals.
Yet, Mr. Specter states that for all the uncertainties and dangers of TB diagnosis and treatment to change, “investments from international aid organizations and from private companies will be necessary”!
He correctly comments that India could begin to solve its TB problem if it followed the example of donor-sponsored HIV/AIDS programming. But then, he follows this suggestion with a misdiagnosis of its provenance by stating that in the 1980s, antiretroviral drugs (ARVs) cost $10,000 per patient in the West, a sum that was a “fantasy” for struggling countries.
It was also somewhat of a “fantasy” in countries like the U.S, where 95% of treatment for AIDS patients was funded through public assistance programs, such as Medicaid. During most of the late 1980s and early 1990s, the technology for AIDS therapies was such that patients were required to take 18-20 tables per day color-coded for ease of administration, often containing other therapies to address adverse reactions to the ARVs themselves, and administered in strict clinical environments. Adherence to this therapeutic regimen was difficult enough in the West without trying to export it to the developing world in resource-limited settings.
It wasn’t the pricing of ARV therapies that limited their use in developing countries. Rather, it was the policy of donors to limit HIV/AIDS interventions to prevention.
In the epicenter of global AIDS, former president Nelson Mandela had his plate full trying to hold South Africa together as a fledging democracy from its founding in 1994. It was not until his sucessor took office that South Africa could initiate in October 2003 a national AIDS prevention and treatment plan. Today, it treats more AIDS patients than any other country in the world.
Throughout the entire Administration of then-president Clinton, 1993-2000, the Agency for International Development was prohibited from funding AIDS treatment. WHO itself recommended only prevention as the best practice for AIDS before finally recommending ARV treatment in April 2002, but only after then-president Bush introduced PEPFAR in January as a comprehensive prevention – treatment program. That was the game changer.
Mr. Specter renders a rhapsodic judgment on India’s generic manufacturers, such as Cipla, for churning “out highly effective medicine at a small fraction of what it cost in the United States”. The lyrics, however, are very different than the music. He fails to mention that these were copy drugs which had not been approved by any regulatory authority. More harm than good may have been done by their use. Beginning in May 2004, WHO had to de-list 36 of these Indian ARVs for lack of proof of bioequivalency to the patented product. Thereafter, the FDA offered to certify any ARV application from any country that wished to have their drugs approved as true generics. Today, over 100 ARVs have won approvals from the FDA, mostly from those manufactured in India.
More importantly, the intellectual property for whatever was manufactured in India came from the West; India itself has yet to produce any innovative ARV therapy from a promising molecule, though today it is the largest supplier of such drugs to the developing world. No Western pharmaceutical company ever instituted a legal challenge to India for breaking their ARV patents, notwithstanding the fact that since 2005 these therapies were protected by WTO rules in which India was a signatory.
Mr. Specter has amply documented the fact that TB is a major problem with the poor in India, and that its government is remiss in its prevention and treatment. In private labs, physicians are well enough paid so that they don’t have to seek second jobs. But for physicians and health workers in the public sector, they do little more than refer patients to private healthcare providers in return for a commission.
He saw first hand how one hospital has had since 2009 a brand new P.C.R. machine which can multiply tiny samples of DNA and examine the genetics of any organism, including tuberculosis. The machine was purchased with money from a government research grant. It was still in its original wrapper. When asked why it was not in use, the Indian physician responded: “no one knows how it works”. After Mr. Specter inquired further, the physician told him “if the [public] doctors used it properly that would interfere with their private practice.” Pressing him once again for a better explanation, the Indian physician commented: “if patients are treated at the [public] hospital, they won’t need to pay for anything else.” So, instead of using the machine, the public physician refers patients to a private physician and then collects a percentage of the treatment costs!
This year, India reached another milestone on its road to self-sufficiency: it informed the donor community that India will cancel certain international aid programs and be the sole arbiter of those programs it wishes to continue. In other words, India will be the master of its own development from here on out, thank you.
In this environment, no amount of international aid for TB control and treatment in India can succeed as long as its government sustains a policy of paying public healthcare workers at a rate so low that it only serves to incentivize them as sales agents for private providers. India has successfully transitioned into the 21st Century; Western journalists might well take note, permitting their readers to see it through that contemporary prism.