Fake Fake Drugs From China: What's

Stopping a Cure for Malaria in Africa?

Can the Chinese pharmaceutical industry overcome its reputation for producing bogus
medicine?
Kathleen McLaughlin
Jun 11 2013, 10:17 AM ET

Kathleen McLaughlin

In 1967, as the United States sank into war in the jungles of Vietnam and China descended
into the cataclysm of the Cultural Revolution, Chinese soldiers secretly fighting alongside the
North Vietnamese also battled swarms of malarial mosquitoes. Showing remarkable
foresight, Chinese Communist Party Chairman Mao Zedong amassed a secret team of top
scientists with one mission: find a cure for malaria.

As China -- then a poor country, barely recovered from a devastating famine -- added insult
to injury by dismantling its scientific, medical, and educational institutions under Mao's
misguided program of political cleansing, the scientists labored on with clear purpose. Within
a decade, some 500 researchers, many of whom were persecuted politically along the way,
developed an ingenious drug called artemisinin, pulling off a medical marvel against the
odds.

The scientists and researchers of the People's Liberation Army's Project 523, named for its
May 23 creation date, made one of China's greatest contributions to modern medicine at the
same time as Mao was destroying the foundations of China's scientific establishment.
Mao's great medical innovation was withheld from the world for four decades because of
Chinese military secrecy and intense global pharmaceutical competition. Today, it is the key
ingredient in the frontline treatment for malaria in Africa.

Yet before artemisinin even has a chance to get a foothold in the battle against malaria, the
drug is in danger of becoming a casualty of China's own overzealous profiteering and global
drug counterfeiting.

In East Africa, artemisinin combination therapy, or ACT, became the preferred treatment for
malaria a few years ago. Along with the massive influx of lifesaving drugs, first from
European manufacturers and now from China, came a deluge of fakes.

In Uganda and Tanzania, whose lands form most of the mosquito-infested Northern and
Southern shores of giant Lake Victoria, the malaria death rates are among the highest in the
world. Widespread regulatory failure and unscrupulous business practices have created a
market flooded with bad drugs. Coupled with China's already bad rap as a producer of
inferior goods such as cheap shoes, knock-off phones, and faulty condoms, the reputation of
China's malaria cure is perched on a precipice.

A small but growing body of evidence partly faults China for the massive upswing in
counterfeit medications in Africa. There is proof of bad medicine originating in China,
including the recent haul in France of 1.2 million doses of fake aspirin, some bound for
Africa. Until now, the deadly risk of fake medications flooding Africa has been under-studied
and under-reported.

"It is an enormous problem," says Nick White, tropical medicine specialist who leads
Southeast Asia programs for Oxford University's Wellcome Trust, which spearheads
groundbreaking research on counterfeit and fake malaria drugs. "It's not like a boil that's
begun to burst, because it's been a problem for a long time. What's happened is we've begun
to recognize it more."

The Wellcome Trust and others estimate that one-third of malaria drugs in Uganda, including
ACTs and all others, may be fake or substandard. From the streets of Kampala to Lake
Victoria's shores, fakes are abundant. Dispensary workers are cagey when asked about fake
drugs, but admit they exist and they can do little to tell which are real and which won't work.

Thousands of private pharmacies have opened in recent years, offering quick remedies to
maladies that have plagued the region for generations. The pharmacy boom has given
counterfeit drug rings a major foothold. Locals routinely blame China for the bad medicine
they peddle.

"I took the drugs I bought in a private dispensary when I had malaria two years ago. Nothing
happened. Two days later I was still with fever, so I went to a hospital and found the drugs
were probably fake," says John Otala, a 32-year-old father of three in Kampala. "We all know
everything that comes from China is fake already, so I believe they may have been Chinese."

There is little relief. Fakes come in expertly copied packaging, down to exactly replicated
logos, country-of-origin labels, and crisp foil strips, capable of fooling even medical
professionals. The best pills bear the same inscriptions as real drugs, but contain little or no
real medication. Only lab tests can spot the bad drugs, and testing equipment is scarce and
expensive. For those with no time to wait in line for a day to see a doctor, taking malaria pills
is a game of chance.

"We all know everything that comes from China is fake already."

Even major Western aid agencies have been duped by fakes of drugs as critical as
antiretrovirals for AIDS patients. As aid donations of free malaria drugs to clinics in sub-
Saharan Africa rise, filling shelves with pharmaceuticals, the patient demand for pills has
boomed: finally there are cures and everyone wants them. But the boom also has opened a
new consumer market for bad drugs.

Experts on the global fake drug racket explain: counterfeit medications follow demand. In the
United States, customers find fake Viagra. When patients hear of a new cure or treatment,
demand skyrockets. In East Africa, patients need malaria medication. Tracking the trade has
proven almost impossible. "The counterfeiters try everything and they try everything to hide
their identities," explains Sabine Kopp, head of the Anti-Counterfeiting and Medicines
Quality Assurance Program at the World Health Organization. "It is very, very difficult to
catch. Even in the studies, you only get a picture of the moment when you do the studies."

Just how dire that picture might be for China's homegrown malaria cures is becoming evident
to the drug's champions at home. Artemisinin's inventors are concerned the damage will
undercut the country's great medical innovation.

Wu Yulin, a 74-year-old veteran of Project 523, helped isolate the chemical structure of
artemisinin in the late 1960s from an herb used as a traditional fever remedy. China used the
plant for decades, but it only went global when the Swiss pharmaceutical giant Novartis
bought the patent and began marketing artemisinin combination therapy (ACT) in the late
1990s. "Authentic ACT is very effective," says Wu, who lives in Shanghai. In Africa and
China, "governments need to strengthen management to crack down on fake drugs. The fakes
will undermine the health of people and will definitely set back the progress and potential of
this medication."

This explosion in fake medications in East Africa did not come without warning, nor has the
growing suspicion of China in Tanzania and Uganda.

As elsewhere across the African continent, China's presence has mushroomed in Uganda in
the past five years. Though there is intense debate over how to quantify China's investment
and aid to Africa, China now is among Uganda's top trade partners and its health aid has
grown from nearly nothing five years ago.

China moved into Africa in its own way, with the government, state-owned companies, and
private businesses all doing deals on their own terms, avoiding involvement with
international organizations that work on health, education, and poverty reduction. The
strategy has been both vilified and lauded as an alternative to Western-style aid, which critics
say comes with too many strings attached.

In 2010, Jerry Lanier, then the U.S. Ambassador to Uganda, detailed in a diplomatic cable
China's growing engagement: "China does not currently collaborate or coordinate with the
United States or other donors in Uganda on areas of seeming common interest like health."
There is evidence this also has led to cutting corners and backdoor deals that might not be in
the best interests of the most vulnerable.

China is sensitive to international criticism of its dealings overseas and has responded by
developing its own health aid. Since it has all but eradicated malaria from within its own
borders and created its own ingenious cure, what better place to focus than Africa?

In recent years, Beijing has promoted plans to open at least thirty malaria treatment centers
across Africa. Yet the malaria clinic in Dar es Salaam that was trumpeted by Chinese state
media was closed when I visited last year, barely a year after it opened. Patients and staff said
the facility was unused because doctors were not trained how to operate the equipment from
China.

There is no reliable source of information to determine the number of Chinese clinics opened
or shut in Africa -- none except perhaps those records kept by the global drug companies
whose salesmen must fill new orders each month. A primary trouble with China's medical aid
on the continent is that it has not been subject to independent oversight.

A lack of follow-through at many clinics has added to a growing negative perception of

China in East Africa.

Yet some Chinese medical aid is working, particularly when it involves manpower. For
example, a team of doctors dispatched from China's subtropical, and once malaria-infested,
Yunnan province to Kampala to work in a newly-funded Chinese hospital has a long roster of
patients eager for their expertise and treatments like acupuncture for pain. Uganda's health-
care system suffers a serious shortage of personnel, so the Chinese doctors are filling a gap.

But even those doctors were running a private, for-profit backdoor pharmacy, undermining
their purely humanitarian aid mission in Uganda. Finally, the Chinese doctors stopped selling
malaria drugs when the pills became legal, according to the store manager. In other words, it
was no longer a profitable sideline. The drugstore now mainly hawks libido-enhancing tea
from China.

Perhaps no one is more sensitive to the issue of counterfeit medicines than China's
government. After my articles on fake drugs in East Africa ran in The Guardian in
December, China's Foreign Ministry called their claims "groundless" and defended its
pharmaceutical industry and its aid to Africa in reports and editorials in state-run media.

"China puts a premium on drug safety and fights resolutely against the production and sales
of fake drugs," Hua Chunying, spokeswoman for China's Ministry of Foreign Affairs, told the
press at a regular briefing in December, four days after one of my articles appeared. "China
follows world-recognized principles and practices in the management of medicine export,
provides certificates to qualified drugs as required by the World Health Organization and
adopts tough measures against fake drugs."

A primary trouble with China's medical aid on the continent is that it has not been subject to
independent oversight.

That was not the case in Uganda, as U.S. Ambassador Lanier pointed out three years ago,
summing up what one sees and hears on the streets of Kampala. Among Lanier's noted
"downside risks" to China's burgeoning investment in Uganda: local resentment over fake
and substandard Chinese products dumped on the local market and exaggerations by China of
its efforts to improve the lives of Ugandans. "In January 2010, the Chinese Ambassador to
Uganda delivered 244,000 doses of two Chinese anti-malaria drugs to Uganda at a public
event that was featured in large paid advertisements in local papers," Ambassador Lanier
wrote, according to the text of a cable revealed by Wikileaks. "The donation nevertheless
only amounted to about one week of Uganda's requirements for malaria treatment."

Of particular concern to Lanier was the misuse of Arco, a highly touted China-made brand of
artemisinin combination therapy. Arco was tested on patients in Kampala but, as Lanier
wrote, "had not been pre-qualified by the World Health Organization ... [even though] ... part
of the funding for the malaria clinic in Mulago hospital was earmarked for testing of these
drugs."

Nearly two years after the delivery of Chinese drugs detailed in U.S. Ambassador Lanier's
cable, Uganda's own Ministry of Health said the drugs were safe, although the WHO had not
approved them.

The deadliest problem remains counterfeiting and fakes, risking lives and threatening to kill
China's potential for real medical aid in Africa.

The global drug counterfeiting trade, a $75 billion-a-year business, is hidden behind layers of
organized crime and by foreign governments and the global pharmaceutical industry, wary of
getting on China's bad side. But as 80 percent of all active ingredients in pharmaceuticals
made worldwide come from either China or India, those two countries are the prime suspects
when it comes to bad drugs.

Corruption and China's damaged reputation are far from what the innovators of Project 523
imagined in their groundbreaking quest for a malaria cure. According to an unpublished
history, New Drugs from Ancient Chinese Remedies: Unsung Heroes in Unusual Times, sent
to me by the author, neuroscientist Yi Rao, and researchers at Peking University, the
discovery of artemisinin by Chinese scientists in 1967 was nothing short of a wonder, given
the chaos of the times.

Chinese traditional healers had been using the leaves of the sweet wormwood plant,
orqinghao, for two centuries to treat malaria and fevers when Project 523 began. Though
villagers in Southern China knew of the plant's curative properties, it took the better part of a
decade for government and military researchers to isolate one particular chemical and the
correct dosing that would cure malaria, not kill the patient.

As Yi describes it, Project 523 was a massive undertaking, especially in a China convulsed
by the destructive decade of the Cultural Revolution, a movement that ruined many other
academic institutions and set back scientific research for years. Yi says the project itself
withstood turmoil by pulling in hundreds of scientists and researchers, many of whom didn't
last long and were replaced as others were purged. Often, scientists would work for a year
only to be replaced as they were consumed by political vendettas. "Participating institutions
were spread across China, involving hundreds of individuals from Beijing, Shanghai,
Yunnan, Shandong, Guangdong, and Guanxi, which borders Vietnam," Yi wrote. "It was
undoubtedly a large collaborative project with contributions from administrators, scientists,
and soldiers who volunteered for tests of the early treatments."
Chemist Tu Youyou joined the project in 1969, a time when "most senior scientists could
barely survive the 'struggles' against them."

Tu got most credit for the discovery, despite its having been the result of the work of 50
institutions and more than 500 scientists. In 2011, she became the first Chinese scientist
working in China to receive the $250,000 Lasker-DeBakey Clinical Medical Research
Award, a prestigious U.S. foundation prize given for medical advances.

Malaria-focused aid groups say artemisinin and resulting ACTs are revolutionary tools for
Africa, yet the intriguing tale of the drug's invention in China and its eventual emergence as a
first-line treatment is getting lost in the deadly battle against fakes and counterfeits.

Festus Ilako, Tanzania Country Director for the African Medical and Research Foundation, is
confident ACTs have dramatically reduced malaria deaths and that the disease can be
defeated with the drugs. Unfortunately, the prevalence of fake medicines in Tanzania,
Uganda, and elsewhere across East Africa is worsening, according to medical professionals
and academics.

"There's actually quite a lot of success against malaria in recent years, mainly because there
are very effective medications that are available," Ilako said in an interview in Dar Es
Salaam. "Artemisinin, when it's used, kills 90-95 percent of the parasites."

But when it's fake, it cures nothing.