Big Pharma Abandons New Tuberculosis Drug Research

Three major pharmaceutical companies - AstraZeneca, Johnson & Johnson and Pfizer - have recently delayed or canceled clinical trials for testing tuberculosis (TB) drugs in India and South Africa. Activists say this is symbolic of a trend by Big Pharma to abandon research into diseases that affect poor people.

TB is an infectious disease that mostly affects the lungs and is caused by bacteria. It is relatively easy to prevent and to cure and has largely vanished from most Western countries with public health programs but it has proven harder to eradicate in developing countries that have poor sanitation. Some 8.6 million people caught TB in 2012 and 1.3 million died from the disease according to the World Health Organization, 95 percent of whom live in the developing world.

To make matters worse, new strains of the disease have emerged that are more difficult and expensive to cure such as Drug-Resistant TB (DR-TB) and Multi Drug Resistant TB (MDR-TB). Scientific researchers have identified two important drugs that could treat these strains - Bedaquiline and Linezolid.

But earlier this month Pfizer, a U.S. company which holds the patent to Linezolid, canceled plans to hold clinical trials for the drug in South Africa. Johnson & Johnson, another U.S. company which holds the patent to Bedaquiline, has failed to conduct research despite winning government approval to start clinical trials in December 2012. Meanwhile AstraZeneca, Anglo-Swedish company, announced this past January that it had stopped early stage research into TB and malaria at its research station in Bangalore, India.

Activists say that this is a serious problem. "Patients for whom current treatment is failing cannot afford to wait," said Julia Hill, South Africa's Access Campaign Officer with Doctors Without Borders (a public health non-profit also known as Médecins Sans Frontières), in a public statement.

One of the main reasons for Big Pharma's reluctance to actively research new drugs is that they do not expect to make much profit from them especially in countries where there is competition.

For example, Pfizer's patented version of Linezolid retails for R676 ($63.88) a pill in South Africa so a full course of treatment with the branded drug can cost as much as $4,000, several times the average salary of most citizens of developing countries. Fortunately a generic version of Linezolid is available in India for Rs 25 ($0.42), which helps reduce treatment costs dramatically.

Unfortunately, however, the Indian pills are not available to patients in other countries. "We can't import these into South Africa," said Julia Hills "because Pfizer has the patent, and is the only company that can sell the drug."

"Big pharmaceutical companies are making huge profits at the expense of the poor. Essential drugs are being sold to the poor more times than in countries like India," said Tinashe Njanji, National Coordinator of the People's Health Movement of South Africa.

Pfizer defends the price at which it sells its drugs. "As with all innovative medicines, the price of Zyvox (Linezolid) is based on the scientific innovation it represents," a company spokesperson told the Financial Times.

Experts say that this is not really true. "Little company R&D (research and development) is devoted to basic research," write Donald Light and Rebecca Warburton in a 2011 article titled "Demythologizing the high costs of pharmaceutical research."  "Although industry association reports, based on unverified numbers from its members, claim that companies invest on average 17-19 percent of sales in R&D...the net corporate investment in research to discover important new drugs is about 1.2 percent of sales."

"Based on independent sources and reasonable arguments, one can conclude that R&D costs companies a median of $43.4 million per new drug, just as company supported analysts can conclude they are over 18 times larger, or $802 million," add Light and Warburton.

Light, who teaches at Princeton University, estimates that taxpayers really pay for something like 80 percent of drug development research. For example, during the global AIDS pandemic of the late 90's, the U.S. government spent approximately $10 billion on effective drug research and development while the pharmaceutical industry spent a mere $10 million, according to Merrill Goozner's 2005 book  "The $800 Million Dollar Pill: The Truth Behind the Cost of New Drugs."

Additional proof that Big Pharma often abandons research into drugs with low profitability was provided recently by Marijn Dekkers, CEO of Bayer, the German a pharmaceutical giant, when he admitted at a Financial Times conference that the company focused on developing medicines "for western patients who can afford it" not for the "Indian market."

In fact, companies really mostly invest in tweaking and prolonging the patents on existing profitable drugs. In another paper co-written with Joel Lexchin at York University in Canada, Light calculated that less than one in six of the 218 new drugs approved by the U.S Food & Drug Administration between 1978 and 1989 had new therapeutic benefits.

Light and Lexchin note that governments have the ability to change this trend by providing incentives to companies who agree to conduct research where needs are greater, since the government ultimately has to approve all new drug research.

"We should consider new ways of rewarding innovation directly. US Senate Bill 1137 proposes the collection of several billion dollars a year from all federal and non-federal health reimbursement and insurance programs, and a committee would award prizes in proportion to how well new drugs fulfilled unmet clinical needs and constituted real therapeutic gains," Light and Lexchin wrote recently in the British Medical Journal.