Maverick medical researchers do what pharmaceutical companies will not
Jay Walljasper | November 2006 issue
When you combine two important subjects covered in the headlines these days—world poverty and extravagant profits in the health-care industry—a challenging and depressing new issue arises. People in the global south are being denied access to lifesaving medicine. What can you do? Curse the greedy drug companies and rail at inadequate aid from wealthy countries? Throw up your hands?
Fortunately a number of health advocates have not given up. Foreign Policy magazine (July/Aug. 2006) reports that doctors are on the verge of effective new treatments and vaccines for diseases like tuberculosis (TB), hookworms and leishmaniasis that weaken or kill millions in the developing world each year. The heroes of this uplifting story are medical researchers who would not accept drug companies’ indifference to diseases that spread so much misery.
These people “have long been abandoned by modern medicine,” states the U.S.-based magazine Foreign Policy. “The reason is simple: The typical victim is too poor to pay for treatment… Only 10 percent of the world’s research dollars is spent on the problems that afflict 90 percent of the world’s population.” The authoritative British medical journal Lancet (May 2006) noted that between 1975 and 2004 just 1 percent of all patented drugs worldwide were earmarked for TB and “neglected diseases” common in poor nations.
But with help from big-ticket funders like the Bill %amp% Melinda Gates Foundation and the U.S. Food and Drug Administration (FDA) as well as their own entrepreneurial savvy, maverick researchers are finding alternative ways to get medicine to the people who need it, regardless of their ability to pay.
Dr. Richard Chaisson, an infectious-disease specialist at Johns Hopkins University in the U.S., found that moxifloxacin, a new antibiotic from the German firm Bayer, showed impressive potential in fighting TB—a disease afflicting 14.5 million people globally, which Foreign Policy notes, “should not really exist in the 21st century. It’s caused by bacteria, and it has been curable [for] 60 years.”
Bayer never even bothered to return Chaisson’s calls about testing their new drug as a TB treatment. Some observers speculate Bayer did not want the lucrative potential of “moxi” as pneumonia treatment in the West to be compromised by becoming identified as a medicine for people in poor countries. Another possible factor: Considerable pressure has been brought to bear on pharmaceutical companies to low-cost drugs used in the developing world, which might also threaten Bayer’s bottom line.
Undaunted, Chaisson made an independent application to the FDA to conduct human trials of the drug among people infected with TB. The agency not only approved his request but offered $1.3 million in funding. Rarely does anyone but the manufacturer submit a proposal to test a drug. Shocked at this turn of events, Bayer is now co-operating with Chaisson. He is grateful, but adds, “It wouldn’t have happened if we hadn’t done an end run around them first.”
After 25 years of research into hookworm, a disabling parasite affects 740 million people in tropical regions, a team led by Dr. Peter Hotezidentified a number of potential sources for a vaccine that could prevent the disease. But no pharmaceutical firms expressed even a flicker of interest in this potential breakthrough. Deeply discouraged, Hotez thought of abandoning his laboratory investigations but decided that he would make one last effort to fund the production of the hookworm vaccine. Together with the Sabin Vaccine Institute, he applied for a grant from the Bill %amp% Melinda Gates Foundation, which seeks to improve health conditions in the global South. His request was unusual: money to start a non-profit partnership to produce and manufacture the vaccine. The Gates Foundation endorsed the unorthodox idea with an $18 million grant in 2000 and $21.8 million last year. Clinical trials are beginning now in Brazil.
Dr. Victoria Hale enjoyed a successful career at the FDA and the biotech company Genentech but at 37 decided to launch her own non-profit organization, the Institute for OneWorld Health, to address neglected diseases. Her first mission was to keep a drug in production that the medical relief group Doctors Without Borders discovered to be a useful treatment against kala azar, a type of leishmaniasis that strikes 500,000 people each year. Pharmacia, the creators of paromomycin, stopped making it when the drug fell out of favour in the West, and the patent was passed on to the World Health Organization, which was also set to stop production.
Hale, with funding from the Gates Foundation, sprang into action, using the last stocks of the drug to conduct trials on its effectiveness against kala azar. The results were conclusive—it cured 94 percent of sufferers—and Hale’s institute found an Indian firm, Gland Pharma, willing to manufacture the drug at low cost.
These pioneers should inspire the world to discover or otherwise make available cures and prevention for other health scourges in the developing world, like HIV (90 percent of all cases are now in the developing world) malaria (which has been estimated to kill a child every 30 seconds), river blindness (which affects 18 million people) and bilharziasis (a parasite plaguing 200 million).