Friday, February 8, 2013
Thursday, February 7, 2013
Tuesday, February 5, 2013
MORE than eight million people get sick with tuberculosis every year, according to the World Health Organization. In 2011, 1.4 million died from it, making it the world's deadliest infectious disease after AIDS. Thanks to billions of dollars spent on diagnosis and treatment over the past decade, deaths and infections are slowly declining. Yet a disturbing phenomenon has emerged that could not only reverse any gains we've made, but also encourage the spread of a newly resistant form of the disease.
In the largest study of its kind, to be published today in the International Journal of Tuberculosis and Lung Disease, colleagues and I have found that fake and poorly made antibiotics are being widely used to treat tuberculosis. These substandard drugs are almost certainly making the disease more resistant to drugs, posing a grave health threat to communities around the world.
Our research team collected samples of two commonly used medicines, isoniazid and rifampicin, from neighborhood pharmacies and markets in 17 countries where tuberculosis is pervasive across Africa, Asia, South America and Europe. Nearly one of every 10 pills we collected failed to meet basic quality standards. In African countries, one in six pills was substandard.
Failing pills typically had too little of the active ingredient — the molecule that destroys tuberculosis bacteria. Most of these drugs came from legitimate manufacturers; they were either poorly made or corroded in transit. The rest appeared genuine, but after researchers tested them and more closely analyzed the packaging, they turned out to be fakes — produced and distributed through criminal enterprises. A pack of fake pills might sell for a dollar on the streets of India, but estimates of the global market for fake drugs range into the tens of billions of dollars.
The World Health Organization recommends that tuberculosis patients receive supervised treatment and quality medicines provided by public health departments. But traveling to the clinics where this treatment is dispensed can be very expensive, especially for poorer patients. Private markets for tuberculosis drugs — where we procured our samples — are often easier to access. For patients in Zambia, for example, treatment through the national tuberculosis program is three times more expensive than self-administering treatment with drugs purchased at local markets. In addition, counterfeiters in emerging markets can infiltrate the legitimate supply chain by submitting falsified paperwork and lying about where the drugs originated. When this happens, most pharmacists have no idea that the products they sell won't work.
Some patients will die outright when shoddy medicines fail to cure them. Others will take drugs with too little active ingredient, killing some of their infection's bacteria but leaving the strongest to multiply. These patients could go on to spread a drug-resistant form of the disease, which is deadlier and vastly more expensive to control.
Back in the 1990s, New York City spent more than $1 billion on an epidemic of drug-resistant tuberculosis. Today, curing a single case of it in the United States can cost more than $200,000. The financial and public health risks for Americans are so great that the Department of Homeland Security has called the most lethal known form of the disease, an extremely drug-resistant tuberculosis called XDR-TB, an "emerging threat to the homeland." Virtually unknown 10 years ago, XDR-TB has now been identified in at least 77 countries — including the United States.
The Food and Drug Administration recently approved a drug called Sirturo, designed to target drug-resistant forms of the disease. While this provides a welcome new hope, we fear it will not be enough. Tuberculosis will not be brought under control until we reduce patients' exposure to substandard medicines.
This is not a problem for just the developing world. While stronger manufacturing practices, more effective regulatory agencies and more alert customs officials help protect the supply here, the United States is not impervious to bad drugs. Last fall, a generic version of Lipitor produced in India was recalled after it was found to contain particles of glass. Since the United States is currently facing a shortage of tuberculosis medicines, it will look to sources outside the country. It must ensure that these drugs are of sufficient quality.
The United States Centers for Disease Control and Prevention is best positioned to lead the fight against substandard and fraudulent tuberculosis drugs. The agency works with public health organizations around the world to stop health threats before they reach our shores. And it is run by Dr. Tom Frieden, who led New York City's successful campaign against drug-resistant tuberculosis in the '90s. The C.D.C. should work with the State Department's new Office of Global Health Diplomacy and the World Bank to help foreign governments, law enforcement agencies and pharmaceutical companies strengthen drug supply chains and prevent companies from making substandard products.
They should follow the lead of the President's Malaria Initiative, which tests every batch of drugs it provides to patients in poor countries, and encourage authorities to do the same for tuberculosis drugs. Drug regulators should also confirm that available medicines are really registered where they say they are (we found that unregistered medicines were more likely to be substandard). Finally, they must prosecute and imprison makers of lethal fake drugs.
As long as substandard tuberculosis drugs are permitted in the marketplace, people will continue to die in pursuit of a cure. And without a coordinated response, growing resistance will eventually render even the highest quality drugs obsolete.
But that story didn't jibe with what physician Dana E. King and his colleagues see walking through the door of their family practice every day in Morgantown, W.Va.
"The perception is that the baby boomers are very active — they are, you know, climbing up mountains, and they are a very healthy bunch," says King, a professor in the department of family medicine at the West Virginia University School of Medicine. "We actually see people that are burdened with diabetes, hypertension, obesity, [and] who are taking an awful lot of medication."
So King and his colleagues mined data from the National Health and Nutrition Examination Survey, a big federal survey, to compare baby boomers — those who are now in their late 40s to 60s — with people from two decades ago who were in that age bracket.
There were some surprises, says King, who, along with his colleagues, reports the results in the journal JAMA Internal Medicine.
Baby boomers are healthier in some important ways. They are much less likely to smoke, have emphysema or get heart attacks. But in lots of other ways, the picture's not so great.
"The proportion of people with diabetes, high blood pressure and obesity [is] increasing. And perhaps even more disturbing, the proportion of people who are disabled increased substantially," King says.
Double the percentage of baby boomers, as compared with the previous generation, need a cane or a walker to get around. And even more have problems so bad that they can't work.
"Only 13 percent of people said they were in excellent health compared with 33 percent a generation ago, and twice as many said they were in poor health," King says. "And that's by their own admission."
King says the reasons are pretty clear: big increases in obesity and big decreases in exercise.
"About half of people 20 years ago said they exercised regularly, which meant three times a week, and that rate now is only about 18 percent," he says. "That's an astonishing change in just one generation."
The impact could be far-reaching if millions of baby boomers are already in such bad shape just as they're starting to grow old.
"The implications for health care costs in the next decade are astounding," King says. "The baby boomers are going into those high medical-use years in much worse condition than their forefathers."
The report comes at a time when the baby boomers are starting to enter old age in large numbers. "There are ... something like 10,000 a day reaching 65," says Richard Suzman of the National Institute on Aging. "It doesn't look good."
Part of the reported decline in health may be that baby boomers look sicker. They're getting diagnosed and treated for health problems their parents never knew they had.
But there may also be something else going on. "I'm part of the leading edge of the baby boom, and I know from personal experience that we have high expectations of life," saysLinda Martin, who studies health trends at the Rand Corp. "And so it could be that the decline in reports of excellent health could simply be that we have [a] higher expectation of what excellent health is."
Despite all this, baby boomers are living longer than their parents. But along the way, they're having a lot more knee operations and taking a lot more pills for blood pressure, cholesterol and diabetes.