The Worldwide Epidemic Of Counterfeit Drugs

Germany was once considered the world's pharmacy. Venerable companies such as Bayer and Höchst were market leaders. Now, distribution of production is global, and that means the black market puts lives at risk.

Counterfeit drugs seized in Germany in 2013
Counterfeit drugs seized in Germany in 2013
Werner Bartens

MUNICH — A deadly epidemic is spreading globally. It can strike at any moment, in any country, and too often goes unnoticed. This epidemic, however, is not some new virus strain making people sick. Death sneaks up on the victims, brought on by that which is actually meant to heal, or at least ease the discomfort of the ill.

Counterfeit drugs pose a huge threat. The precise extent of the danger is unknown, but the World Health Organization (WHO) and other authorities agree that a growing number and types of counterfeit drugs are being circulated — and, according to their estimates, up to one million people die because of such illicit products every year.

But contaminated or adulterated drugs are not the only dangerous part of this formula. Another serious problem is incorrect dosage in the production of the medication. The substances used may be clean, but too much or too little of an active ingredient can have lethal consequences or render the treatment too slow, or ineffective.

The cause of death is still classified as undetermined for Robert Allen, a 44-year-old who had received infusions containing blood thinners in Phoenix, Arizona in 2008. He is one of dozens of patients in the U.S. who died after receiving adulterated heparin, a blood-thinner. His widow Charlisa, a physician herself, sued the drug's producer, Baxter. Legal proceedings have been long and the case is only now going to court, nine years after Allen's premature death.

In 2008 it was discovered that heparin produced in the Chinese city of Changzhou had been adulterated. In the United States alone, the Federal Drug Administration (FDA) has traced at least 81 deaths to the drug. In addition, there were nearly 800 reports in the U.S. of serious health incidents following the administration of heparin, most of them anaphylactic shock cause by an allergic reaction. In Germany more than 80 serious incidents involving adulterated heparin were reported. But in those cases it was heparin distributed by the pharmaceutical company Rotexmedica, based in Schleswig-Holstein, Germany, not Baxter.

The blood thinner is extracted from pig intestines. In the Changzhou area, there are 30 factories that produce heparin for the global market and many German and American pharmaceutical companies get their products from there.

The FDA was forced to admit that "it couldn't entirely understand the Chinese trade routes." It also admitted that it had not inspected the Changzhou plant, usually a legal requirement. Chances that an American or German authority would close down production of a plant when imperfections are found in a drug are small. A spokesperson for the German Federal Institute for Drugs and Medical Devices (BfArM) lamented at the time that organizing onsite inspections "is not that simple. Addresses in China are hard to understand."

So does drug safety depend on language skills? The Munich-based author and director Daniel Harrich has researched the matter for years and interviewed victims. The German TV station ARD broadcast his film Poison, as well as the documentary Dangerous Medicine, which explains the networks operating within the pharmaceutical sector. His book Pharma Crime was published by the Heyne publishing house.

I was shocked by the extent to which people's health is compromised to make money

The titles sound drastic, but this is not a matter of scare-mongering. The WHO warns that, "no countries remain untouched by this issue." The organization notes that what was once a problem typically limited to countries in the developing world has now become an issue for all, in large part because the Internet has accelerated the globalization of the drug market.

As always, the poorest countries are the worst afflicted. In sub-Saharan Africa 30-40% of medicines are counterfeit, and in Russia, Asia and Latin America the rate is estimated at 10-20%. In North America and Europe only 1% of drugs are believed to be counterfeit, but this would mean an estimated 1.4 million medicine packages yearly in Germany alone.

"I saw a lot in my 30 years working for the criminal investigations agency, but when I worked the pharmaceutical industry, I was shocked by the extent to which people's health is compromised in order to make money," says the former security chief of one of the world's largest pharmaceutical companies, asking to remain anonymous. "German pharmacies are relatively safe, but you are not immune from counterfeit medicine. Everything is being counterfeited, from antibiotics to the pill."

Huge profit margins have long attracted organized crime, and not only are lifestyle products counterfeited, but even very expensive cancer drugs. "In Germany I don't think the danger of counterfeit medicines is great," says Wolf-Dieter Ludwig, head of oncology in Berlin and chairman of the Drug Commission of the German Medical Association (BfArM). "But we do have patients from abroad, like Russia for example. It is a huge problem there. With some medicines, such as antibiotics, we are able to tell that they do not work because the blood test results do not change."

André Said of the Federal Union of German Associations of Pharmacists, says the battle is on against the black market. "We have been competing with criminals for years, trying to prevent counterfeit drugs from ending up on the market," he said. "Production and distribution are intertwined, and more transparency would be a distinct advantage,"

The German drug commission BfArM has tried to trace the origins of components of all 17,546 drugs under their authority. Of these, 19% have at least one active ingredient produced in China, and 37% have at least one active ingredient made in India, the BfArM report said. And four out of five drugs in German pharmacies contain no active ingredients produced in Germany.

Indian-made drug alternatives posted online — Photo: Nick Gray

Germany was once considered the world's pharmacy. Venerable companies such as Bayer and Höchst were world market leaders. Now, price pressure and profit-making have led to the distribution of production around the world. While every simple egg sold in a market has a stamp providing information about its origin, with medicine it is nearly impossible, even for experts, to determine where the components were made. "The production of raw materials, active ingredients, excipients, intermediate products, and the final release of products can all take place in different places," says Maik Pommer from BfArM. "Marking medicine, as one does with eggs, is therefore not possible. But production sites in foreign countries are subject to monitoring, some of which is conducted by competent authorities from EU Member States."

Can this succeed? The bare-bones Indian pharmaceutical company shown in Poison was not some movie set but a drug production site certified by the local regulatory authority. And is it really possible that there are no health incidents caused by adulterated medicine in Germany?

In March, Rotexmedica, the Schleswig-Holstein-based company, recalled some of its heparin injection solutions. There were "reports of its ineffectiveness' of the blood thinner after it was administered. The lot in question, No. 60,502, consisted of 205,000 vials distributed to 68 hospitals in Germany. Management said this was "not due to defective quality," but rather "reduced efficacy, which caused no harm to patients." But how can they be sure: What if a medicine, like heparin, is not effective as a blood thinner and blood clots form?

The active ingredient in heparin batch recently recalled by Rotexmedica also hails from a Chinese factory. The company defended itself saying it was "a distributor certified by the German authorities." But according to a statement made by Rotexmedica, the last official control of the Chinese heparin supplier was conducted in June 2014.

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Ecological Angst In India, A Mining Dumpsite As Neighbor

Local villagers in western India have been forced to live with a mining waste site on the edge of town. What happens when you wake up one day and the giant mound of industrial waste has imploded?

The mining dumpsite is situated just outside of the Badi village in the coastal state of Gujarat

Sukanya Shantha

BADI — Last week, when the men and women from the Bharwad community in this small village in western India stepped out for their daily work to herd livestock, they were greeted with a strange sight.

The 20-meter-high small hill that had formed at the open-cast mining dumpsite had suddenly sunk. Unsure of the reason behind the sudden caving-in, they immediately informed other villagers. In no time, word had traveled far, even drawing the attention of environment specialists and activists from outside town.

This mining dumpsite situated less than 500 meters outside of the Badi village in the coastal state of Gujarat has been a matter of serious concern ever since the Gujarat Power Corporation Limited began lignite mining work here in early 2017. The power plant is run by the Power Gujarat State Electricity Corporation Limited, which was previously known as the Bhavnagar Energy Company Ltd.

Vasudev Gohil, a 43-year-old resident of Badi village says that though the dumping site is technically situated outside the village, locals must pass the area on a daily basis.

"We are constantly on tenterhooks and looking for danger signs," he says. Indeed, their state of alert is how the sudden change in the shape of the dumpsite was noticed in the first place.

Can you trust environmental officials?

For someone visiting the place for the first time, the changes may not stand out. "But we have lived all our lives here, we know every little detail of this village. And when a 150-meter-long stretch cave-in by over 25-30 feet, the change can't be overlooked," Gohil adds.

This is not the first time that the dumpsite has worried local residents. Last November, a large part of the flattened part of the dumpsite had developed deep cracks and several flat areas had suddenly got elevated. While the officials had attributed this significant elevation to the high pressure of water in the upper strata of soil in the region, environment experts had pointed to seismic activities. The change is evident even today, nearly a year since it happened.

It could have sunk because of the rain.

After the recent incident, when the villagers raised an alarm and sent a written complaint to the regional Gujarat Pollution Control Board, an official visit to the site was arranged, along with the district administration and the mining department.

The regional pollution board officer Bhavnagar, A.G. Oza, insists the changes "aren't worrisome" and attributes it to the weather.

"The area received heavy rain this time. It is possible that the soil could have sunk in because of the rain," he tells The Wire. The Board, he says, along with the mining department, is now trying to assess if the caving-in had any impact on the ground surface.

"We visited the site as soon as a complaint was made. Samples have already been sent to the laboratory and we will have a clear idea only once the reports are made available," Oza adds.

Women from the Surkha village have to travel several kilometers to find potable water

Sukanya Shantha/The Wire

A questionable claim

That the dumpsite had sunk in was noticeable for at least three days between October 1 and 3, but Rohit Prajapati of an environmental watchdog group Paryavaran Suraksha Samiti, noted that it was not the first time.

"This is the third time in four years that something so strange is happening. It is a disaster in the making and the authorities ought to examine the root cause of the problem," Prajapati says, adding that the department has repeatedly failed to properly address the issue.

He also contests the GPCB's claim that excess rain could lead to something so drastic. "Then why was similar impact not seen on other dumping sites in the region? One cannot arrive at conclusions for geological changes without a deeper study of them," he says. "It can have deadly implications."

Living in pollution

The villagers have also accused the GPCB of overlooking their complaint of water pollution which has rendered a large part of the land, most importantly, the gauchar or grazing land, useless.

"In the absence of a wall or a barrier, the pollutant has freely mixed with the water bodies here and has slowly started polluting both our soil and water," complains 23- year-old Nikul Kantharia.

He says ever since the mining project took off in the region, he, like most other villagers has been forced to take his livestock farther away to graze. "Nothing grows on the grazing land anymore and the grass closer to the dumpsite makes our cattle ill," Kantharia claims.

The mining work should have been stopped long ago

Prajapati and Bharat Jambucha, a well-known environmental activist and proponent of organic farming from the region, both point to blatant violations of environmental laws in the execution of mining work, with at least 12 violations cited by local officials. "But nothing happened after that. Mining work has continued without any hassles," Jambucha says. Among some glaring violations include the absence of a boundary wall around the dumping site and proper disposal of mining effluents.

The mining work has also continued without a most basic requirement – effluent treatment plant and sewage treatment plant at the mining site, Prajapati points out. "The mining work should have been stopped long ago. And the company should have been levied a heavy fine. But no such thing happened," he adds.

In some villages, the groundwater level has depleted over the past few years and villagers attribute it to the mining project. Women from Surkha village travel several kilometers outside for potable water. "This is new. Until five years ago, we had some water in the village and did not have to lug water every day," says Shilaben Kantharia.

The mine has affected the landscape around the villages

Sukanya Shantha/The Wire

Resisting lignite mining

The lignite mining project has a long history of resistance. Agricultural land, along with grazing land were acquired from the cluster of 12 adjoining villages in the coastal Ghogha taluka between 1994 and 1997. The locals estimate that villagers here lost anything between 40-100% of their land to the project. "We were paid a standard Rs 40,000 per bigha," Narendra, a local photographer, says.

The money, Narendra says, felt decent in 1994 but for those who had been dependent on this land, the years to come proved very challenging. "Several villagers have now taken a small patch of land in the neighboring villages on lease and are cultivating cotton and groundnut there," Narendra says.

They were dependent on others' land for work.

Bharat Jambucha says things get further complicated for the communities which were historically landless. "Most families belonging to the Dalit or other marginalized populations in the region never owned any land. They were dependent on others' land for work. Once villagers lost their land to the project, the landless were pushed out of the village," he adds. His organization, Prakrutik Kheti Juth, has been at the forefront, fighting for the rights of the villages affected in the lignite mining project.

In 2017, when the mining project finally took off, villagers from across 12 villages protested. The demonstration was disrupted after police used force and beat many protesters. More than 350 of them were booked for rioting.

The villagers, however, did not give up. Protests and hunger strikes have continued from time to time. A few villagers even sent a letter to the President of India threatening that they would commit suicide if the government did not return their land.

"We let them have our land for over 20 years," says Gohil.

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