The Bitterest Pill: Maybe China Isn’t Counterfeiting Drugs
After a May report finding a third of the malaria pills inspected in Asia and Africa were counterfeit, observers piled on pharmaceutical companies in India and China as likely bad guys. But the truth is a little harder to swallow.
Are unscrupulous pharmaceutical companies in China and India really to blame for fake malaria pills showing up in Asia and Africa?
Probably not. This past May, the prestigious medical journal The Lancet published findings that 30 percent of 1,700 malaria pills tested in Southeast Asia and West Africa didn’t work. In one-in-three cases, a box labeled as treatment for the mosquito-borne plague actually contained pills made with inert chemicals, expired active ingredients, or ingredients cut to stretch one pill into several—enough to fill the box, each scantly more medicinal than an M&M.
The Malaria Research Institute at Johns Hopkins University estimates as many as half a billion people contract malaria and a million die of the disease in the world’s tropical belts each year. An estimate by the World Health Organization says only 216 million are infected and 660,000 die annually, which is more conservative but still pretty ghastly.
The Lancet study, which was funded by the U.S. National Institutes of Health, urged further study of Chinese and Indian supply chains for malaria meds. Presented subtly in the research, the implication of wrongdoing by Chinese and Indian drugmakers got shrill once it hit the international press in June. Soon the World Health Organization had hauled out its representative in China, Michael O’ Leary, to defend the Chinese pharmaceutical industry, and announce that the world health body had created a “pre-qualification” system for Chinese pharmaceutical companies. (O’Leary can be heard making a cogent defense of the Chinese pharmaceutical industry here, in an interview on Australian radio broadcast two months ago.)
So if it wasn’t skeevy pharma outfits making millions of fake pills, how did they get on the shelves?
Two ways. In Asia, intellectual property concerns have so far trumped public health concerns, allowing small counterfeit operations to thrive. “The criminal making chalk pills in his garage is being lumped in with the reputable company,” said Roger Bate, an American Enterprise Institute researcher who has accompanied police raids on counterfeit pill labs in India, and who has advised the FDA on detecting fraudulent medicine.
Large Chinese and Indian pharmaceutical firms have more to lose by damaging their brands than they would gain in cutting ingredients from their product. “If you’re one of the better generic producers, you’re getting hammered by this,” said Bate. Making fake pills does not require a large factory, and a small criminal has a lot to gain by posing as a legitimate pharmaceutical company. “The most expensive things to buy are the packaging machine.”
The problem is not new. “I thought it was common knowledge,” said Mark Little, the director of the Pharmaceuticals and Biotech project at BSR, a San Francisco business consultancy. The May paper struck him as positive attention for addressing the problem, but unsurprising.
Public health officials in Asia and the U.S. had noticed this some time ago, too. NIH itself had claimed 25 percent of malaria pills were fake in 2005—seven years before its current study. Separate research found evidence of 53 percent of drugs failing efficacy tests in sub-Saharan Africa in 2008. Media coverage has been surprisingly consistent, given the shock that greeted the May finding. Smithsonian magazine investigated the problem extensively three years ago, as had the BBC. The list goes back to the late 1990s.
“Some of the guys working on this [issue] have been working on it for 12 years,” said Bate, “I think the reason you got a full court press on this is it was NIH, it was Lancet.”
The business of malaria treatment did not get as much attention, but everyone we called to explain the 30 percent number talked about it a lot. The story goes like this:
Because malaria infects so many people, often in poor countries, margins are low and competition between legitimate brands of medicine is fierce. At the same time, the disease is so common, medicine to treat it is sold over the counter in many regions, and much of it taken without proper medical oversight. “The reality is that probably two-thirds of people with malaria self-treat. So they never even speak to a doctor,” said Bate. “If you’ve got a kid who’s got a fever, it’s probably harder to get a [malaria] test than it is to get the drugs.”
The chaos leads large-scale pill producers to focus on defending their brands, rather than pushing better regulation of products – that’s the local government’s problem. In many cases, intellectual property concerns take precedence over public health concerns.
Even more complicated, the fake pills often seem to work. Malaria causes terrible suffering – night sweats, the famous “bonebreak fever” feeling in your joints—but it doesn’t kill adults very often. With a fatality rate in single digits for healthy adults, most people recover—and assume the medicine saved them. Worse, the logic flips when malaria claims a victim, usually a child – malaria causes one in five deaths of children in sub-Saharan Africa, according to WHO. In that case, families tend to chalk the tragedy up to the terrible disease’s violence, not the failure of the medicine.
How to fill the quality assurance hole?
“Take the [intellectual property] out of this, force people to just focus on the quality” of the medicine, argued Bate. “But can I get the International Chamber of Commerce and the US Chamber of Commerce to do that? I can’t because their members are obsessed with it. They’re pissed, because China keeps stealing their shit.”
We got a written response to that argument from Steve Tepp, the lawyer on intellectual property for the U.S. Chamber of Commerce’s Global Intellectual Property Center. Tepp argued that IP concerns shouldn’t, and perhaps can’t be distinguished from public health concerns. “The fight against counterfeit medicine IS the fight for effective drugs, because counterfeits raise the risk of failing to treat a serious medical condition, or potentially harm the patient more,” he wrote. A malaria pill was, in practical terms, comparable to any other product subject to piracy.
“The danger of counterfeit products and the approach of the criminals is essentially the same across all industries,” he wrote. Counterfeiters make cheap versions of popular products, from medicines to children’s toys, from sports jerseys to microchips for military jets. They do not adhere to safety standards so the products at best fail to function and at worst hurt people who use them.”
The NIH-funded study focused on samples of drugs bought on the Thai-Cambodian border. Numerous studies have suggested that partial dosages from fraudulent medication have contributed to the disease’s increasing resistance to treatment. A summary of the resistance issue prepared for the Gates Foundation is here. It’s terrifying.