偽劣藥品的大威脅

假劣抗生素害人不淺

羅傑·貝特 2013年02月08日

華盛頓
據世界衛生組織(World Health Organization)透露，每年有超過800萬人罹患結核病。2011年，有140萬人死於結核病，這使結核病成為除艾滋病以外世界上最致命的傳染 病。幸虧過去十年間在疾病診斷和治療方面投入了數十億美元，結核病的死亡率和感染率在慢慢下降。但現在出現了一個令人不安的現象，這種現象不僅會讓我們前 功盡棄，還會刺激新型耐藥性結核病的傳播。

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通過開展這一領域最大規模的研究，我和同事們發現，假冒偽劣的抗生素正被廣泛用於結核病的治療，《國際結核病與肺部疾病雜誌》 (International Journal of Tuberculosis and Lung Disease)將在今天刊登我們的研究成果。幾乎可以肯定的是，這些不合格藥品導致結核菌抗藥性增強，給世界各地的民眾帶來了嚴重的健康威脅。

我們的研究小組從17個國家的社區藥店和市場中收集了異煙肼(isoniazid)和利福平(rifampicin)兩種常用藥品的樣本，在這些非 洲、亞洲、南美和歐洲的國家中，結核病是一種非常普遍的疾病。我們收集的藥品中，幾乎每十粒就有一粒沒達到基本的質量標準。在非洲國家，六分之一的藥品不 合格。

通常，不合格藥品中消滅結核病菌的有效成分含量極低。其中大多數藥品是由合法製藥商生產的，它們要麼是製造工藝低下，要麼在運輸途中受損。其餘藥品 像是真的，但在研究人員對藥品進行測試、對包裝進行更仔細地研究後發現，這些葯是通過犯罪集團生產和銷售的假冒產品。在印度的大街上，一包假藥可能會賣1 美元（約合6.23元人民幣），但全球市場中假藥的價值估計高達數百億美元。

世衛組織建議結核病患者接受“全監督治療”，服用公共衛生部門提供的優質葯。但前往提供這種治療方法的診所的費用可能非常高，特別是對那些貧窮患者 來說。人們通常很容易在結核葯私人市場購買到藥品，我們的樣品就源自這些市場。例如，對於贊比亞的病人來說，通過國家結核病項目治療疾病的費用比在當地市 場購買藥品進行自我治療的費用高三倍。此外，新興市場的仿製者可以通過提交偽造文件、編造藥品來源地進入合法供應鏈。出現這種情況時，大多數藥劑師都不知 道他們出售的藥品不會發揮藥效。

當一些病人服用假藥而無法治癒時，他們會馬上死亡。其他人會服用有效成分含量極低的葯，這些葯會殺死一些傳染病病菌，但會導致最強壯的病菌大量繁殖。這些病人進而會傳播一種耐藥性結核病，這種疾病更為致命，而控制相關病情的費用也要高得多。

20世紀90年代，紐約市治療耐藥性結核傳染病的費用高達10億美元。而如今，在美國治療一個這種病患的費用就超過20萬美元。這對美國的經濟和公 共健康帶來了巨大風險，因此國土安全部(Homeland Security Department)已將已知的最致命的結核病——XDR-TB稱作“針對美國的新威脅”。這種廣泛耐藥性結核十年前還不為人知，但現在至少有77個國家確認存在這種疾病，其中包括美國。

美國食品與藥品管理局(Food and Drug Administration)最近批准了一種名為Sirturo的藥品，它被專門用來治療耐藥性結核。雖然這個決定非常受歡迎，給人們帶來新希望，但這 可能還不夠。如果我們不降低病人服用不合格藥品的幾率，結核病就不會得到控制。

這不只是發展中國家存在的問題。雖然美國的製藥能力較強，監管機構能夠更好地發揮作用，海關官員也更為警覺，幫助保護了美國的藥品供應，但美國並非 不受劣質藥品的影響。去年秋天，印度生產的非專利葯立普妥在被發現含有玻璃渣後被召回。由於美國目前面臨結核葯短缺的問題，美國將會依靠國外來源。因此， 美國必須確保這些藥物的質量過關。

美國疾病控制與預防中心(Centers for Disease Control and Prevention)最適合來領導打擊不合格及假冒結核葯的行動。該機構與世界各地的公共健康組織合作，主動出擊，在此類健康問題威脅到我們的國土之前 將其消滅。該機構負責人是湯姆·弗里登(Tom Frieden)，他曾在20世紀90年代帶領紐約民眾成功抗擊耐藥性結核病。疾控中心應該與國務院新設立的全球衛生外交辦公室(Office of Global Health Diplomacy)及世界銀行(World Bank)合作，幫助外國政府、執法機構，以及製藥公司強化藥品供應鏈，防止一些公司生產不合格藥品。

它們應該效仿總統防治瘧疾行動計劃(President’s Malaria Initiative)——對美國為貧窮國家的病患提供的每一批藥品進行測試，並敦促相關的政府部門對結核葯採取同樣措施。藥品監管機構應該確認現有藥品的註冊地真實可靠（我們發現未經註冊的藥品更有可能不符合標準）。最後，他們必須起訴、監禁致命假藥的製造者。

只要市場上存在不合格的結核葯，人們仍會為了治療疾病而死亡。如果不展開協調一致的行動，日益加大的耐藥性將最終致使最優質的藥品不再有效。

羅傑·貝特(Roger Bate)是美國企業研究所的常駐學者，著有《假藥：致命的假冒偽劣藥品》。

翻譯：許欣

Feeding a Disease With Fake Drugs

By ROGER BATE February 08, 2013

WASHINGTON
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.

Roger Bate, a resident scholar at the American Enterprise Institute, is the author of “Phake: The Deadly World of Falsified and Substandard Medicines.”