A growing epidemic of deadly fake medications

[Al-khiyal]

Asia is seeing an "epidemic of counterfeits" of life-saving drugs, experts say, and the problem is spreading. Malaria medicines have been particularly hard hit; in a recent sampling in Southeast Asia, 53 percent of the anti-malarials bought were fakes.

Bogus antibiotics, tuberculosis drugs, AIDS drugs and even meningitis vaccines have also been found.

Estimates of the deaths caused by fakes run from tens of thousands a year to 200,000 or more. The World Health Organization has estimated that a fifth of the one million annual deaths from malaria would be prevented if all medicines for it were genuine and taken properly.

"The impact on people's lives behind these figures is devastating," said Dr. Howard Zucker, the organization's chief of health technology and pharmaceuticals.

Internationally, a prime target of counterfeiters now is artemisinin, the newest miracle cure for malaria, said Dr. Paul Newton of Oxford University's Center for Tropical Medicine in Vientiane, Laos.

His team, which found that more than half the malaria drugs it bought in Southeast Asia were counterfeit, discovered 12 fakes being sold as artesunate pills made by Guilin Pharma of China.

A charity working in Myanmar bought 100,000 tablets and discovered that all were worthless.

"They're not being produced in somebody's kitchen," Newton said. "They're produced on an industrial scale."

China is the source of most of the world's fake drugs, experts say.

This month, the Chinese government announced it was investigating whether the former chief of China's Food and Drug Administration had taken bribes to approve drugs.

The director, Zheng Xiaoyu, was in office from the agency's creation in 1998 until he was dismissed in 2005 after repeated scandals in which medicines and infant formula his agency had approved killed dozens of Chinese, including children.

"The problem is simply so massive that no amount of enforcement is going to stop it," said David Fernyhough, a counterfeiting expert at the Hong Kong offices of Hill & Associates, a risk-management firm hired by Western companies to foil counterfeiters.

The distribution networks, he said, "mirror the old heroin networks," flowing to Thai distributors with financing and money-laundering arranged in Hong Kong. The penalties are less severe than for heroin.

Daniel Chow, an Ohio State University law professor and an expert on Chinese counterfeiting, said he believed that the authorities would pursue counterfeiters "ruthlessly" for killing Chinese citizens but be more lax about drugs for export.

"The counterfeiters aren't stupid," he said. "They don't want anyone beating down the door in the middle of the night and dragging them away, so they make drugs for sale outside the country."

A spokesman for the Chinese Embassy in Washington said that he had "no idea" whether most of the world's counterfeits came from China, but that Zheng's arrest proved China was cracking down. He also said counterfeiters would get the same punishment no matter whom they hurt.

Many of the fake artesunate pills found by Newton's team were startlingly accurate in appearance — and much more devious in effect than investigators had suspected.

Not only did the pills look correct, as did the cardboard boxes, the blister packing and the foil backing, but investigators also found 12 versions of the tiny hologram added to prevent forgery.

In one case, even a secret "X-52" logo visible only under ultraviolet light was present, though in the wrong spot.

Another hologram was forged by hand, Newton said, by someone who obviously spent hours with a pin and a magnifying glass making tiny dots on a circle of foil to imitate the shimmer.

But the most frightening aspect appeared when the pills were tested. Some contained harmless chalk, starch or flour. But the latest, he said, contained drugs apparently chosen to fool patients into thinking the pills were working.

Some had acetaminophen, which can temporarily lower malarial fevers but does not kill parasites. Some had chloroquine, an old and now nearly useless anti-malarial.

One had a sulfa drug that in allergic people could cause a fatal rash.

And some had a little real artemisinin — not enough to cure, but enough to produce a false positive on the common Fast Red dye test for the genuine article.

Those would not merely fool a laboratory, Newton noted. They could also foster drug-resistant parasites, so if patients were lucky enough to get genuine artemisinin treatment later, they might have already developed an incurable strain and could die anyway.

Such resistant strains could spread from person to person by mosquito and ultimately render the drug ineffective, as already happened with chloroquine and Fansidar, two earlier malaria cures.

"We make no apology for the use of the term 'manslaughter' to describe this criminal lethal trade," Newton and his co-authors said last year in an article in The Public Library of Science Medicine.

"Indeed, some might call it murder."

In the United States, finding counterfeit drugs in pharmacies is very rare, "but we've seen a lot from Internet sellers posing as legitimate pharmacies," said Dr. Ilisa Bernstein, director of pharmacy affairs for the U.S. Food and Drug Administration.

Thus far, few counterfeits of life-saving drugs have been found in the United States. Most are drugs used or abused for fun, like Viagra, the painkiller Oxycontin and sleeping pills. Investigators have, however, found fake statins, which could eventually lead to a heart attack, and fake Tamiflu, which could be fatal in a pandemic of lethal flu.

Fake drugs have a long history; the film noir masterpiece The Third Man, based on a real criminal case, involves adulterated penicillin in post- war Vienna.

And in the 1600s, after conquistadors discovered that South American cinchona bark cured malaria, Europe was flooded with fake bark. "It caused a great loss of confidence in it as a cure," Newton said. "We're seeing history repeat itself."

The problem with anti-malarials is worst in Asia, but is growing rapidly in Africa.

For example, in September, the Nigerian authorities found $25,000 worth of counterfeit malaria and blood pressure drugs concealed in a shipment of purses from China.

The temptation for counterfeiters is likely to grow because money to fight malaria is being poured into the Third World.

President George W. Bush's $1.2 billion Malaria Initiative avoids the problem by buying directly from Western pharmaceutical companies like Novartis, said Dr. Trenton Ruebush 2nd, an adviser to the initiative.

By contrast, the Global Fund to Fight AIDS, Tuberculosis and Malaria gives money directly to poor countries to buy their own drugs, and sends auditors to follow up. But 80 percent of the world's nations, pharmacology experts estimate, lack drug agencies capable of detecting sophisticated counterfeits.

"The countries are supposed to purchase from WHO-qualified manufacturers, but there are places where things can go wrong where we wouldn't necessarily have control," said Dr. Bernard Nahlen, the fund's malariologist. "In some countries, there is, let's say, a certain lethargy about paying attention to these issues. You have to take the government's word for it, and anybody can pull the wool over anybody's eyes."

The Global Fund, which appointed a new director on February 8, is considering adopting central purchasing, a spokesman said.

A global alert system for counterfeit drugs has existed for 16 years, first by fax, and now on the World Health Organization Web site, said Dr. Valerio Reggi, chief of the anti-counterfeiting task force created last year by the organization.

"But it isn't used very much," he said. "Regulators are human beings, and it's difficult to identify a benefit for those who report to it."

Reggi said the task force would try to change that by drawing attention to the problem and getting harsher laws passed. As he pointed out, in many countries, "counterfeiting a T-shirt means 10 years in jail, but counterfeiting a medicine can be a misdemeanor."

A growing epidemic of deadly fake medications in Asia

[amalgamate]

whoa- how could this counterfeit problem grow to such ridiculous measures? I'm sure we've got some counterfeits here in the US sure but not to that extent where major industries are opened for just making and distributing fake meds! doesn't that make them an easy target for the Chinese govt to trace them and shut them b***rds down? I can't believe the death rate cause by these fake meds. yes that is an epidemic- and more than 50% of the anti malarial drugs were found fake!!?? that's absurd!! what the heck is the FDA of china doing? -or not doing. that's insanity. there's some low-down dirty b****rd counterfeits working in the FDA! you can't distribute any medication unless it goes through FDA approval first. the parallel positive results from hundreds of experiment conducted throughout decades of work decide weather the med is safe for distribution.
man, that's devastating if the health system of china is being bombarded by phonies! actually they're scientists- chemists, all working together- who then can the people trust to produce authentic medication for thier loved one's symptoms!? that's called BIOTERRORISM and i never thought it could grow and spread to such measures- slaughtering tens of thousands of men, woman and kids annually. oooh that makes me sick...

allahu akbar alaihun, allahu akbar alaihun

[Shotokan_Karate]

...that's called BIOTERRORISM and i never thought it could grow and spread to such measures- slaughtering tens of thousands of men, woman and kids annually...

Well observed Amalgamate!

This is the kind (amongst many) of surreptitious terrorism that many governments and organisations are allowed to get away with. Then we wonder why there's so much hatred and bloodshed going on in the world! Atrocious!

P.S. Welcome to A.com

[amalgamate]

Well observed Amalgamate!

This is the kind (amongst many) of surreptitious terrorism that many governments and organisations are allowed to get away with. Then we wonder why there's so much hatred and bloodshed going on in the world! Atrocious!

P.S. Welcome to A.com

Thanks Shotokan. i'm happy to be here

[Al-khiyal]

PANAMA CITY, Panama (AP) - Panamanian investigators exhumed six more bodies Thursday to determine whether the deceased died from ingesting medicine contaminated with diethylene glycol, a chemical cousin of antifreeze.

The exhumations bring to 18 the number of bodies authorities have dug up in the past several days after receiving requests from suspecting family members.

They are part of an investigation into a scandal in which companies allegedly sold tainted ingredients to the government health agency, which used them to produce medicines that have been blamed in the deaths of at least 51 people. Dozens more were sickened by the medications contaminated with diethylene glycol, which can cause kidney and neurological damage.

The first documented poisonings were reported in October, but authorities said there may have been earlier cases that went undetected.

On February 12, the first group of 12 bodies was exhumed. Five days later, the Attorney General's office confirmed that they had found traces of diethylene glycol in two of the first four bodies they analyzed. The examination of the remaining eight bodies is ongoing.

Panama exhumes six more bodies in contaminated-medicine probe

[Al-khiyal]

Dr Dora Akunyili's determination to confront corruption means she has to travel with 10 armed guards after several attempts on her life.

She shocked Nigeria's fake drug racketeers by taking the fight to them after becoming director-general of the country's food and drug agency, Nafdac, in 2001.

Bureaucratic inertia and rampant corruption meant the drugs regulator had not been effective, and she had to sack 300 of its 3,000 staff, including her brother-in-law, to get a grip on the corruption. She has hired women because men are "more susceptible to corruption".

Trained as a pharmaceutical scientist, she is now a crime fighter. Her sister, a diabetic, died after taking fake insulin in 1988, before doctors and the authorities became aware of the counterfeiting problem.

Dr Akunyili, who has become a national hero, says of fake medicine: "It is one of the greatest atrocities of our time. It is mass-murder. It is a form of terrorism."

Such is the danger from the drugs gangs that her husband, a doctor, also requires guards and her youngest child was sent to the US after a kidnapping attempt. Nafdac's offices and laboratories have been hit by co-ordinated bomb attacks, destroying equipment and records.

She says: "It's not done by all Nigerians. It's done by very few murderers that have been living off the blood of people for many, many years and felt that nobody should stop them. It didn't really occur to me that these people would fight to this level."

Dr Akunyili's car has also been ambushed and she had a miraculous escape when a bullet burned her scalp. A nearby bus driver was killed in the attack.

The Nafdac staff carry out raids in Lagos, Nigeria's largest city, twice a week to seize the bogus medicine, which is then destroyed in fires. But even then, people have been arrested trying to snatch boxes of drugs from the flames.

The 52-year-old official says: "We have another problem of lack of or inadequate legislation. Because the laws against drug counterfeiting are weak and it is at the same time as lucrative as other criminal activities, criminals are now shifting from gun-running and carrying of cocaine and heroin and other hard drugs, to counterfeiting of medicines."

She has called for international legislation to make mandatory the reporting of fake drugs, in line with other industries.

She says: "Drug companies, I can tell you without any fear of contradiction, most of them are more interested in their money. They are much more interested in their money than in the health of the people. Understandably, they are in business. But they forget that this is a business that affects life."

Racketeers shocked by woman who fought back

[Al-khiyal]

13 April 2007 -- The world's major drug companies have been accused of turning a blind eye to the multibillion-dollar trade in fake medicine that has resulted in an explosion of child malaria deaths in developing countries.

Governments have not tackled the problem and pharmaceutical companies are burying the issue, afraid that any publicity given to their medicines being faked will lead to a fall in the sale of the genuine product, according to a documentary.

The problem has been particularly acute with the treatment of malaria in Africa, with anti-malaria drugs faked on an industrial scale. Professor Nick White, of Oxford University, one of the world's leading experts on malaria, said: "We estimate that there are more than one million deaths each year - which is the equivalent of seven jumbo jets going down every day. And 90 per cent of those deaths are in children."

Professor White said that counterfeit medicine was a major reason why malaria had become, over the past 30 years, Africa's biggest child killer, from an illness that used to be easily treated with medicines.

Some of the fake drugs contain no medicine at all, but others have tiny traces of the real ingredients - which leads to another, potentially bigger problem: it allows the malaria parasite to build up resistance to the drug.

Nigeria's campaigning drugs regulator, Dora Akunyili, described counterfeiting as "mass murder". She told the documentary, which will be aired today on The Business Channel, a satellite station: "The fake drug racket and the silence associated with it have led to the resurgence of malaria... The companies kept quiet. The regulators were paid off and everybody was helpless. Drug counterfeiters operated in this country and in most developing countries for almost three decades, unchallenged."

There is now just one family of drugs left that malaria has not built up resistance to, Artemisinins - which are also being faked. Professor White said: "Resistance to the Artemisinins would be an absolute catastrophe for our current attempts to try to control malaria."

It is estimated that the global fake drug racket is worth $40bn (£20bn) a year, and between 50 and 90 per cent of medicine in some African and Asian countries is counterfeit. Graham Satchwell, the former head of security at GlaxoSmithKline, the British-based global pharmaceutical giant, told The Independent: "Each therapy area is highly competitive, so if one person's drug is undermined, their market share will suffer. It takes a brave company to say they have a problem."

Mr Satchwell said that the "majority of the industry are sitting on their hands", rather than tackling the problem - for instance through radio tracking of their products. He also pointed out that the figures from the industry's own organisation, the Pharmaceutical Security Institute, showed many cases of counterfeiting in the US, but hardly any in China or Africa - despite firm evidence from other sources that tens of thousands die each year in China and Africa as a result of fake medicines each year.

Dr Akunyili said: "If the companies had risen up to their responsibilities early enough, the issue of the preponderance of fake drugs would not have gotten to the level it got in Nigeria. It is this silence that is actually largely encouraging drug counterfeiting"

Dr Martin Meremikwu, of Calabar University Hospital, in southern Nigeria, said that he had seen child malaria deaths soar. He said that, by the time children who had been treated with fake drugs got to the hospitals, it was often too late to save them.

"Malaria should not kill people. It's a curable disease. But if the patient uses the wrong drug - either because they are fake or they are ineffective because of higher resistance - then they are lying here with complications.

"And in children, young children, the time between a mild disease and a severe disease can be as little as eight hours, or 24 hours or 12 hours. So time is of the huge essence here. You really cannot afford to try some other drug before trying a good one. You can't. Because you don't have that time."

The drugs don't work

* Counterfeit medicines are swamping unregulated markets in developing nations with unknown and sometimes fatal results. Not only are thousands dying needlessly, but patients are also becoming immune to the effects of the real thing. Counterfeit drugs occasionally contain small doses of the active ingredient - enough to induce resistance

* The UN World Health Organisation estimates the incidence of counterfeit medicines is about 10 per cent in developing countries, with prevalence higher where regulatory control is weakest. But in many parts of Africa, according to the WHO, as well as in some countries in Latin America and South Asia, prevalence sits at around 30 per cent. The patients hit are the sickest and the poorest.

* WHO estimates that 200,000 of the one million malaria deaths every year would be prevented if all the drugs taken were genuine. The popularity of combination malaria drugs - which are more expensive than other treatments - has seen counterfeit peddlers cash in on the opportunity to boost sales. In Cambodia, Tanzania and Cameroon, up to 90 per cent of such drugs on sale in local markets are believed to contain nothing but chalk or maize flour.

* As recently as 2001, about 68 per cent of medicines in circulation in Nigeria were unregistered, and as much as 41 per cent were believed to be fake.

Drug giants accused of ignoring fake medicines that kill millions