Contact l Sitemap

home industries issues reasearch weblog press

Home  » Industries » Pharmaceuticals

AFRICA: Death By Dilution

by Robert CockburnAmerican Prospect
December 20th, 2005



In Graham Greene’s 1949 thriller classic, The Third Man, Harry Lime -- “the dirtiest racketeer who ever made a dirty living” -- peddles diluted penicillin through the sewers of occupied Vienna. During the film’s famous scene atop the city’s Great Wheel, Harry’s friend Holly Martins, played by Joseph Cotten, asks, “Have you ever visited the children’s hospital? Have you ever seen any of your victims?”

“Victims?” replies Orson Welles as Harry, pointing to the tiny figures moving far below them. “Would you really feel any pity if one of those dots stopped moving -- forever? If I said you can have £20,000 for every dot that stops, would you really, old man, tell me to keep my money -- without hesitation?”

* * *
In Vienna, Virginia, not far from Washington, a database of all the fake drugs discovered by the world’s 18 largest drug companies is kept at the Pharmaceutical Security Institute (PSI). The data maintained by the PSI may well hold the key to saving millions of innocent consumers from ingesting lethal counterfeits of the industry’s best-selling medicines -- but it remains inaccessible to outside inquiries for what the industry calls “security” reasons. Fake drugs are indeed the pharmaceutical industry’s most closely guarded secret.

But in September 2002, at a conference in Geneva, a man named Emmanuel Kyeremateng Agyarko made a startling admission. The conference brought together top government officials, scientists, private investigators, and the world’s biggest drug companies for the first global forum to discuss the explosion of fake pharmaceutical drugs in a racket spreading to the West. The media were expressly not invited into the meeting at the luxury hotel overlooking Lake Geneva.

Speaking up from the audience, Agyarko explained how one month earlier he had discovered a deadly counterfeit of the children’s malaria syrup Halfan, which had been diluted to 40-percent strength. Halfan is made by the British drug giant GlaxoSmithKline (GSK). The syrup is a lifesaver for serious cases in Africa, where a resurgence of malaria is killing more than a million people a year, 90 percent of them children under 5 years old.

The fake was discovered on sale in a pharmacy in Kumasi, Ghana’s second-largest city, with a population of approximately 862,000. “It was atrocious,” he recalls of the diluted medicine. “At 40 percent, if anybody takes it they won’t get the desired effect, particularly children. Any malarial infection that is not properly treated could easily end up losing the child.” As chief executive of the Ghana Food and Drug Board, Agyarko says he prepared a warning and then called GSK.

What followed is disputed to this day.

According to Agyarko, corporate staff from GSK’s London headquarters came to his office, took away five bottles of the fake syrup for testing -- and asked him to withhold any warning. “We were going to issue a public statement,” Agyarko explained, until, he said, GSK told him, “‘Please, don’t put that in the press. If you do this you will damage our product.’” He recalls that GSK offered to send in a sales team to remove fake Halfan from Kumasi if his agency kept the story out of the media.

“ [GSK] raised the issue of a problem with the brand if you go out and say that there is a batch that is counterfeited … . They sort of talked us into accepting the fact that if we did [report the fakes], it would badly affect the product. I wouldn’t want to use the word ‘pressure.’ We were encouraged to the view that this was not something that was a large amount.”

After his meeting with GSK, Agyarko’s agency issued no warning. He later came to fear that children could have died as a result of that decision. The company never reported back to him, and he suspected that fakes were still available. “If it does come up again I would not hesitate at all to go public on the matter,” he says now. “I wouldn’t give [GSK] the benefit of doing it themselves.”

Did GSK indeed ask him to withhold the warning? Did children in Kumasi suffer or die from using fake Halfan? At the time, GSK advertising featured a photograph of a healthy, smiling African girl to project the image of a caring company. The corporate Web site opened with the girl’s picture and the GSK mission statement: “Our global quest is to improve the quality of human life by enabling people to do more, feel better and live longer.” Moreover, GSK depicts itself as an industry leader in fighting pharmaceutical fakes. “Fake drugs can kill people,” according to the company’s official policy. “Counterfeits deceive patients.”

When I brought Agyarko’s story to the attention of GSK’s director of international public policy, Jessica Hughes, the corporate response was adamant denial. Louise Sibley, then GSK’s vice president for communications, denied that the Kumasi incident ever occurred, and went further to deny that the company had ever received Agyarko’s alert or his fake Halfan samples. In a corporate statement, she said, “[W]e were not provided with any samples of fakes by the authorities in Ghana, nor were any reports of fakes lodged with us.”

Informed that Agyarko was sticking to his claim, Sibley promised, “If there’s a misunderstanding I’ll run this into the ground.” I suggested that the company’s security director, Graham Satchwell, would know whether GSK had received Agyarko’s alert and samples. “I put in a call to Graham Satchwell, but I think he must be traveling,” she later told me, adding, “I don’t think we are going to have anything more to say on it.”

It was simply Agyarko’s word against GSK’s, and because he insisted that the company had the only evidence, the controversy might have ended there. But a pair of Oxford University scientists had reason to suspect that Agyarko’s story might be true. Based in Bangkok, professor Nicholas J. White and Dr. Paul Newton of Oxford’s Centre for Clinical Vaccinology and Tropical Medicine had been rebuffed by GSK when they asked about fakes of Halfan syrup for research to assess the spread of counterfeit malaria drugs in Southeast Asia.

“It’s despicable,” says the lean, shrewd White, at 54 one of the world’s top malaria experts. “One packet or bottle is the difference between life and death. Poor people normally invest everything in that one medicine. You’ve got one shot and that’s it. They often don’t know why they are suffering and their children have died.” At the scientists’ request, Agyarko teamed up with them to try to prove that the company indeed had received his fake samples, and to find out what GSK really knew about the fake Halfan. White had also asked me to assist the team’s research because I had reported on the racket for the London Guardian and Times newspapers over a period of almost 20 years. (One night before flying back to Beirut in 1982, I met a marketing executive from Beecham (now GSK) who asked me to look for counterfeits of his company’s Amoxil antibiotic, which he believed “the PLO was faking.” After an investigation that included a frightening car chase, I learned that everyone on all sides of the Middle East conflict was making over 50 fakes of well-known medicines because the trade was so lucrative.)

* * *
Why would a caring company want to stop a warning that could save a sick child? In fact, had Agyarko uncovered one of the main causes of the extraordinary spread of fake-drug racketeering? Had the years of inadequate regard for Third World customers by the pharmaceutical industry and governments allowed the racket to move out of the backstreet labs to become a vast criminal enterprise that now accounts for 10 percent of all available medicines? Agyarko’s story offered the first insight into why the racket flourishes largely unchallenged -- and sparked a demand to break the industry’s secrecy.

What began as a hunt for those missing bottles eventually revealed a murderous global trade in fake drugs targeting the sick, vulnerable, and poor. It grew into a survey to discover what major drug companies do -- and don’t do -- to warn patients about fakes. Agyarko’s missing bottles were only a symptom of a far deeper state of denial -- and a clue to the resurgence of malaria in Africa.


* * *
In essence, the global trade in fake drugs operates as a mirror of legitimate commerce. The producers of fakes sell them to dealers who infiltrate them into the retail market. Profits flow from the capacity to counterfeit valuable commodities at very low cost. As the fakes pass from producers to wholesalers to retail outlets, everyone can take a profit and yet still deny complicity.

The pharmaceutical industry and the agencies responsible for protecting the public differ widely on the magnitude of the counterfeiting problem. The Food and Drug Administration (FDA) estimates that around 10 percent of all available medicines are now faked in a racket earning $35 billion a year. The figure exceeds 50 percent in parts of Africa and Asia. The PSI estimate is between 1 percent and 2 percent. Within the industry, however, that figure has little credibility. In a scathing editorial in April 2005, the online U.S. magazine PharmaManufacturing.com asked: “Why does the industry continue to shy away from developing the infrastructure needed to assess the size of the global problem? The answer is simple: fears of bad publicity and impacts on stock prices.”

Millions of people are left to suffer and die from fake drugs while the industry denies access to information that doctors say could save them. The industry insists that its data on fake drugs must be restricted for security and to avoid public panic. But White believes that the underlying reason is simply profit. In a chilling assessment of pharmaceutical-industry ethics, he says, “Their marketing people must have made the calculations that they are likely to make more profits by not publicizing than by publicizing.”

The Oxford team concluded that most fake-drug data is kept secret because drug companies fear that publicity will harm sales of brand-name drugs in a fiercely competitive business. That has been the industry practice for over 25 years, but the human toll is gradually emerging. In 2001, China reported that 192,000 of its citizens had died from fake drugs. White guesses that between 500,000 and 1 million people die from fakes every year. “I believe that people must have died in their millions,” agrees Dr. Dora Akunyili, the drug regulator of Nigeria and an associate of the Oxford team. “It is mass murder -- terrorism against public health.” To her, companies that conceal fake drugs are not much better than criminals. “They are [maintaining secrecy] because of their selfish gain, because they don’t want to lose money,” she says.

This month Akunyili, 47, will receive the 2005 Grassroots Human Rights Campaigner Award in London’s Houses of Parliament. The streetwise scientist cuts a dashing figure with her traditionally colorful Nigerian costume and hats -- one of which she keeps in her office shot through by the bullet that creased her scalp when she was attacked in a hail of gangster gunfire.

Only as fake drugs spread into lucrative western markets are drug companies and governments finally contemplating determined action against a scheme that the makers of Rolex watches and Gucci handbags have fought in public for decades. There are two victims of fake drugs: companies that lose sales and patients who lose their health. Why don’t they work together? GSK’s Louise Sibley told me, “It’s not our job to give public-health warnings. We don’t make the fakes.” Drug companies pursue fake-drug manufacturers by using their own security and hiring private investigators to trace and facilitate the closing of fake-drug factories. By using covert means, the industry avoids any assessment of its efforts and is accountable to no one.

* * *
The Oxford team’s first break in the Ghana case came when Dr. Newton found a GSK laboratory analysis of counterfeit Halfan syrup in an obscure Internet technical journal on mass spectrometry. He wondered whether that syrup came from Agyarko’s bottles. The GSK research center in Britain had made a breakthrough in identifying fake-drug ingredients -- the chemical “fingerprint” -- in the samples. Their tests showed that the fake syrup contained no halofrantrine active ingredient and had two sulfa additives that Newton knew to be dangerous and should have been made public. But GSK’s scientists, who had quoted Newton’s own research on fake malaria drugs in their report, rejected his request for the source of their fake syrup. “Analyzing counterfeit products of ours can be a very sensitive issue, and if I was to give you further information I would need to clear it with our corporate security and investigations department,” a GSK researcher told him in an e-mail. “The product presented in the paper was found in Central Africa, but for legal reasons, I can’t be more specific at the moment.”

The courteous, donnish White then wrote to Satchwell, the GSK security chief, asking for the source of the fake Halfan syrup and to know whom, if anyone, GSK had warned. A reply arrived from the company’s international public-policy director, Jessica Hughes, who refused to provide answers about the fake syrup but acknowledged “counterfeit Halfan is present in Nigeria and Sierra Leone.”

The Oxford team’s hunt moved to Nigeria, the hub of West Africa’s fake-drug trade and a country notorious for corruption and violence. In June 2002, Nigeria’s drug regulatory body, the National Agency for Food and Drug Administration and Control (NAFDAC), had also alerted GSK to a discovery of fake Halfan syrup -- two months before Agyarko’s warning. As NAFDAC’s chief, Akunyili had issued an immediate public warning through a system set up to identify fake drugs to patients and health workers. Every month, in fact, NAFDAC destroys tons of fake drugs. A typical list includes faked versions of products from the Pfizer, Hoffman La Roche, Novartis, Unilever, Janssen, Astra Zeneca, Boots, Hoechst, Pharmacia & Upjohn, and GSK companies.

Akunyili was furious to hear that her Ghanaian colleague Agyarko had withheld his public warning at GSK’s request. “No company would have the courage to tell me not to publish anything,” she says. “We will still issue a warning even if we find it in just one shop. If you find any fake-drug product in only one shop you can be sure it is in many villages … . People die all the time.” She is driven by the death of her sister Vivienne, a diabetic who received fake insulin. She says that she herself has been a victim of fake Halfan and Amoxil antibiotics. There had been no public warning in either case. “I didn’t know that Halfan had been faked,” says Akunyili. “Everybody can be a victim.” She joined NAFDAC in 2001 when Nigeria suffered from a wave of fake drugs comprising up to 80 percent of the market. Now she is a national hero, known as “Dr. Dora,” who publicizes the counterfeits in schools and villages, roots out corruption, and travels to India and China to stop the fakes at their source.

Eventually the Oxford team learned that GSK had known about a global trade in fake Halfan since at least December 2000, when Belgian customs officials seized a vast haul of GSK counterfeits in transit from China to Nigeria. The Belgian haul included 57,600 packs of fake adult Halfan capsules, along with more than 15,000 packs of Amoxil and Ampiclox antibiotics. GSK says it informed the Nigerian health authorities of the haul. The counterfeiter’s trial revealed that fake GSK drugs were being produced on an industrial scale in factories in China and Thailand. In all, Chinese investigators seized 43 tons of fakes of 17 brands made by seven major drug companies, which only represented a fraction of known output. Chinese authorities say that in 2001 they closed 1,300 fake-drug factories while investigating 480,000 cases worth $57 million.

White’s attempts to publish the Oxford team’s findings were rejected by the leading medical journals -- including The Lancet, the British Medical Journal, and The New England Journal of Medicine -- and several U.K. newspapers. But in October 2004, one year after GSK had denied any knowledge of his fake Halfan discovery, bbc Radio reported Agyarko’s claims. Faced with the broadcast, the company’s London head office reversed position to acknowledge that it had received Agyarko’s alert -- and that it had the fake Halfan syrup bottles all the time. In a new statement that admitted GSK staff had “bumped into” Agyarko, the drug giant still insisted that “[a]t no point was any pressure put on the Ghanaian authorities not to issue a public warning on fake Halfan.”

By then Louise Sibley had left GSK. Louise Dunn, the company’s new vice president for communications, had a new explanation. “There was some confusion over the interactions with Mr. Agyarko,” she said. “The key point here is that there was no wrongdoing.” Neither Sibley nor Dunn had ever called Agyarko, although Dunn says that he “never complained to us.” She added, “There was no intention to hide anything. In our view there were minor discrepancies.”

Among those discrepancies was the complete disappearance of the fake Halfan bottles that the company finally admitted receiving from Agyarko. GSK claims that no trace of the Kumasi fake Halfan sample survives. “Mr. Agyarko did provide us with a sample of the Halfan,” says Dunn. “But we don’t have any records of the tests. What our procedure would be now is that absolutely everything gets tested at the time.” She says it is no longer possible to compare the Kumasi fake to other fake Halfan syrups in Africa, which would be the key to mapping their source and spread. The disappearance of the critical evidence also eliminated any chance of using the syrup’s chemical fingerprint to identify possible victims.

As for the fake Halfan syrup whose test results were found online by Newton, Dunn says that sample came from Sierra Leone. She says that the company informed the Sierra Leone minister of health about those counterfeits. But the Pharmaceutical Board of Sierra Leone, which investigates all fake drugs and issues public warnings, never received any such information from GSK or the minister of health, according to the board’s director, Michael J. Lansana, who called the omission “unfortunate.” The head of Sierra Leone’s Malaria Control Program, Dr. Sirian Kamara, who works with Lansana to uncover fake drugs, also says that no warning ever arrived.

Most curiously, the news of Agyarko’s fake Halfan alert never reached Graham Satchwell, then GSK’s security director. Asked about the Agyarko case at a conference in Paris in March, he was stunned. “I know nothing of that!” he shouted from the conference platform. “If you are trying to suggest that I would [in] any way conceal anything that would cause the death of anyone, let alone children, then you are very mistaken indeed.”

Later, Satchwell told me that he had led GSK’s anti-counterfeiting operations, and that he should have received all reports of fake drugs, including Agyarko’s Halfan find. He said no one at GSK told him about the Kumasi case or about the attempts to contact him concerning Agyarko’s claims. A former U.K. policeman, Satchwell took personal risks as an undercover buyer to obtain fake drug samples. He has testified at congressional hearings on fake drugs. Sir David Hare, the British dramatist, has lionized Satchwell’s integrity in a play exposing government and corporate negligence. Why was he not told about the Agyarko case?

“There is a large anti-counterfeit team at GSK,” says Dunn, “so the involvement or noninvolvement of one individual is not unusual or significant.” But Satchwell questions the official GSK version.

“If GSK knows that the [fake] sample was received,” he says, “then they should know who received it and what happened next. If a test was undertaken, then the results would have been recorded. The department concerned with doing that were an efficient and organized bunch.” Satchwell was pushing to build up a record of all fake GSK drug cases to be used for intelligence analysis to trace sources and pathways. “There are umpteen things you can profile within the packaging and the product in order to identify counterfeit ‘strains.’ This was -- and is -- done.”

GSK declined to allow any interviews with Louise Sibley or the GSK staffers who met with Agyarko. As for Satchwell’s comments, Dunn says, “We have no comment.” The company’s fake-drug policy states, “GSK rigorously investigates any case of suspected counterfeiting.” But GSK still refused to answer questions about the actions it took following the fake Halfan syrup find in Kumasi. And Dunn says she cannot understand how withholding fake-drug data can harm patients. “I would like some evidence,” she says.

There is no way of finding such evidence -- yet. For “security” reasons, the industry’s fake-drug data is kept confidential at the PSI, which collates fake-drug discoveries made by the world’s 18 biggest drug companies, including Pfizer and GSK, some dating back more than a decade. The institute’s stated goals are “protecting the public health” and “sharing information on the counterfeiting of pharmaceuticals.” Whether it fulfills either is questionable. Dr. Lembit Rago, director of medicine safety for the World Health Organization, has been frustrated by the PSI’s secrecy. “We’ve been discussing it with [the PSI] for a long time,” he says, “but they are not willing to open up the databases. They really don’t like [the idea].”

A PSI spokesman insists that the secrecy is necessary to prevent criminals from being tipped off before police arrests. But Chris Jenkins, a founding member of the PSI now serving as an analyst and associate director at Pinkerton Consulting and Investigations, says there is an additional explanation. “At the outset, we [PSI] were against having data online that anyone could interrogate,” says Jenkins, who set up the original psi fake-drug computer data system in the 1990s, with its access restrictions. “There were also commercial reasons. If a patient came to harm as a result of a counterfeit product, the company’s good reputation is in danger of disappearing, together with a loss of confidence in the products. From the company’s perspective, there is then the inherent danger of rival products being preferred in the marketplace.”

Jenkins says that the industry’s security regime was designed to prevent the major drug companies from using fake-drug information to take commercial advantage of one another.

“The one thing we were trying very hard to do was to keep [data] out of the hands of the commercial people in any of the companies,” he says. “We always had this possibility, which is why things were sanitized. One had to produce reports for the CEO, but beyond that it was kept very close. The only people [in a member company] nominated to PSI were senior people with anti-counterfeit responsibilities, such as security directors and IP lawyers. You can imagine trying to get 20 top companies trying to share information, a lot of which was extremely commercial-in-confidence. The importance of meeting sales targets is such that you can even find cutthroat competition between different operating divisions of the same company, let alone between two companies competing in the same market with similar drugs.”

Could that explain why Graham Satchwell never learned of the fake Halfan in Ghana?

Dr. Sebastian J. Mollo of the PSI confirms that data is routinely withheld from members. “Since [PSI’s] inception, it was recognized that a great deal of this information would remain confidential and would not be disseminated. There is proprietary information that cannot be disclosed, either to peer member companies or to the general audience.”

The industry has turned fake-drug data into a potential weapon against itself, inadvertantly offering the racketeers a layer of immunity they never could have imagined. Some companies have, on rare occasions, issued public warnings, including GSK (and Johnson & Johnson, Serono, Hoechst, Wellcome Foundation [now GSK], Merck Sharp & Dhome, and Genentech), but the list is tiny compared with the racket’s size. “Fake drugs should be reported like infectious diseases,” says White. “By not making the public aware you create a market (for fakes). Drug companies are making it easier for the criminals.”

High profits, low costs, minimal legal risks, and little publicity are drawing crime gangs away from arms and narcotics. High-tech photocopiers turn out perfect drug packaging for every type of treatment for heart disease, birth control, meningitis, kidney disease, cancer, or depression. Out-of-date and damaged drugs get relabeled for sale, transforming a $22 drug into a $450 drug by creating a higher dosage label.

Most fakes are made in China, Southeast Asia, India, Russia, and the Middle East and then infiltrated into the legitimate global drug-distribution system. What is surprising is how many ordinary people are needed to make the racket work. Officials and health workers meant to protect patients are bribed and intimidated to put fake drugs into a distribution system that is like a sieve. “An awful lot more [fake drugs] get through than are seized,” says Jenkins. Inside the system, fake drugs are very hard to find and then are often ignored, even in the United States.

Once taken, a fake antibiotic pill made of rice starch or a vaccine made of water is virtually untraceable in the body. Victims succumb to their illnesses, leaving no sign of a crime. In the absence of investigations, very few victims have ever been unidentified. Its anonymity has allowed the racket to be ignored and to thrive.

The most vulnerable are malaria victims. The resurgence of malaria now affects more than 500 million people in Africa. Mosquitoes carry the disease in a “meal of blood” passed from one human victim to another. The most dangerous parasite, Plasmodium falciparum, kills more than 800,000 African children under 5 years old annually, according to the World Health Organization. It is Africa’s biggest child killer, destroying families, health services, and economies. But the role of fake drugs in promoting malaria is barely ever mentioned.

In November 2005, for example, Bill and Melinda Gates gave $250 million to fight malaria. “It’s a disgrace that the world has allowed malaria deaths to double in the last 20 years, when so much could have been done to stop the disease,” declared the Microsoft billionaire. “Millions of children have died.” Is Gates aware that his generosity and the efforts of pharmaceutical research-and-development staff are being diluted by fake drugs? Experts are linking the resurgence of the disease to the growth of fake drugs, in a terrible cycle of neglect over the past two decades.

The explosive growth of malaria has created a sales boom for both drug companies and counterfeiters. “Anti-malarial drugs have now really become the focus” of the fake racket, says Dr. Allan Schapira of the World Health Organization’s Roll Back Malaria project. “It is murder. It is incredibly cruel.”

* * *
The marketing of fake drugs and the resurgence of malaria are inseparable. “It kills the voiceless children, who cannot protest,” explained Dr. Martin Meremikwu of Nigeria’s Calabar University at the launch in October of Gsunate Kit, a new artesunate anti-malarial drug. “Malaria hardly kills adults, which explains why we don’t seem to give the fight against malaria enough attention. The tragedy is that while 90 percent promptly take drugs when they have malaria, only 15 percent get ‘good’ drugs. The fraudulent practice of fake-drug manufacturers, inappropriate use of the available drugs, and the mutation of the malaria parasite are responsible for the resistance of malaria parasite to drugs.”

No one has assessed the extent of fake malaria drugs in Africa along the lines of Newton's study in Southeast Asia. Anti-malarials are known to be among the most faked drug types. But the danger does not stop there. The use of fake drugs is helping the malaria parasites to quickly mutate to become resistant to new drugs. Akunyili says diluted fake drugs are “feeding the malaria parasite with little doses” that build more resistant strains. You don’t have to take a fake drug to suffer its effects. Resistance is accelerated and then spread by mosquitoes to the next victim. As more patients fall prey so the need for more drugs grows, encouraging the trade in fakes that fuels the cycle. Dr Jan Rozendaal, who ran the European Community malaria project in Southeast Asia’s Mekong region in 1998, believes that fake drugs were causing most malaria deaths. But such warnings have gone largely unheeded. This leaves questions about the effectiveness of any new drugs while the use of fakes is rife.

There is a lot of money to be made now in combating malaria. GSK’s tests of an experimental malaria vaccine on children in Africa were greeted last year with a ringing headline in the London Times: “Malaria vaccine to save millions of children.” Within a month, the British government had made an unprecedented $5 billion presale for the still-unproven vaccine (and was criticized by malaria experts for investing so much in one Western company).

But while a company can be paid billions for a new drug, its patients have no guarantee of getting the real thing. There is little incentive to publicize the danger. Vaccines have been faked with tragic results. The 1995 Niger meningitis epidemic led to the worst known fake-drug incident, when 60,000 people were given vaccines made by SmithKline Beecham (now GSK) and Pasteur Merieux before they were found to be nothing but water. Some 3,000 people died. SmithKline Beecham was criticized in the French press for failing to take legal action amid speculation that it feared damaging trade with Nigeria, which had donated the fake vaccines.

* * *
Has the pharmaceutical industry made a huge miscalculation by using a strategy that now harms its own interests as well as its customers? Without effective laws or close cooperation among companies, governments, and international organizations, the racket has metastasized, according to the Public Library of Science Medicine, which finally published the Oxford team's industry survey in April. White and Akunyili now want international legislation to end the secrecy by enforcing mandatory reporting by drug companies of all fake-drug finds, and for government authorities to investigate and issue public warnings. “This is not a role for the pharmaceutical industry which has a serious conflict of interest,” says White, who also wants PSI data opened to health authorities. “The information kept on PSI databanks could absolutely help limit the number of casualties from fake drugs. It is entirely preventable.”

Akunyili says the next and most difficult step in the campaign against counterfeit drugs is to identify the victims. In the case of Halfan, it could be possible to detect the link between the criminal and the victim by checking the chemical fingerprint developed by GSK against that of the fake syrup. But is there any will to find the victims?

The pharmaceutical industry, backed by the FDA, is pursuing a new methods to stop counterfeiting, such as high-tech covert markers in drug packaging. But when GSK put holograms on its Halfan, according to Akunyili, “these criminals faked their hologram.” She believes that consumers represent an untapped pool of highly motivated “detectives” who could expose fake drugs to protect both themselves and the industry. White agrees that the public should be told which drugs are being faked without companies revealing sources. Such public warnings directly attack the racket itself. “When people stop buying fakes the market dries up,” says Akunyili. “Companies benefit in the long term.”

When the racket began to take off in 1982, Hoechst pharmaceuticals discovered the power of publicity against counterfeits in Beirut, where wartime conditions had encouraged a plague of fakes. Hoechst fought back with an advertising campaign warning patients about a fake of its diabetes drug Daonil. There was no panic and there were no lost sales. Indeed, Hoechst says it gained credibility, and when its customers stopped buying fakes the supply dried up. Why don’t drug companies use this vast resource of human intelligence and let consumers check their own drugs?

Clearly the companies worry that the victims will come back to haunt the industry -- creating the legal and public-relations disaster the secrecy was meant to prevent. Chris Jenkins believes that the PSI could face a legal challenge to open its databases. “Only the PSI has an overview of the known racket,” he says. “In theory, every fake-drug case reported by the companies should be on there.” Pieced together, the PSI fake-drug data could reveal the scale of the racket and its human toll through specific companies, drug names, discovery dates, and locations. Jenkins and other private investigators fear that they, too, could be held liable for keeping confidential the fake-drug data they have obtained for pharmaceutical clients.

Such fears have been stimulated by a series of breakthrough court cases in the United States, which argued that a drug company may be liable for the safety of its customers if it possesses information that could save them. It is a question with implications for millions of patients around the world.

It will probably never be known if any children suffered from diluted Halfan in Ghana. But in 2002, around the same time that the fake syrup turned up in Kumasi, prosecutors in a courthouse in Kansas City were exposing the horrors of fake drugs in America -- and the identity of their victims.

On December 5, 2002, Kansas City District Judge Ortie Smith changed the perception of the racket from that of copyright infringement to mass murder. Pharmacist Robert R. Courtney pleaded guilty to diluting the cancer drugs Gemzar, made by Eli Lilly, and Taxol, made by Bristol Myers-Squibb. Courtney made extra money, and at least 17 patients died. Judge Smith told him, “Your crimes are a shock to the conscience of a nation, the conscience of a community, and the conscience of this court. You alone have changed the way a nation thinks.” He sentenced the pharmacist to 30 years in prison.

Investigations by the FDA and the FBI -- of a case that had been the FBI’s top priority until September 11 -- found that since 1992, Courtney had diluted 72 different medicines, affecting some 400 doctors and more than 4,000 patients. During the hearing Assistant U.S. Attorney Gene Porter apologized for identifying the victims by code numbers instead of their names. Noting that they were indeed persons, Porter read out the names of the 17 women who died without any warning from Courtney’s diluted drugs. They were, wrote Kansas City Star reporter Mark Morris, “brave women, fighting desperately against cancers that never seemed to get better, no matter how many treatments they endured.”

What happened next riveted the attention of the pharmaceutical industry -- and its lawyers.

Victims and surviving families filed hundreds of lawsuits against Courtney and against Eli Lilly and Bristol-Myers, alleging that the two companies knew or should have known that Courtney was diluting their drugs because sales data showed that he sold greater quantities than he bought. The companies denied any liability and argued that they had no duty to protect their customers from Courtney’s criminal acts. But faced with the prospect of a legal precedent that could hold drug companies responsible for fake-drug victims where they had knowledge of the racket, Eli Lilly and Bristol-Myers Squibb settled more than 300 lawsuits out of court -- without any admission of wrongdoing. In February 2003, Courtney’s victims received around $71 million in settlement payments from the companies.

What would such an investigation reveal in Kumasi, or a thousand other African or Asian communities? Whether it is brought about in courts or through government action, the mandatory reporting of fake drugs would save potential victims everywhere.

* * *
In the 2004 GSK corporate responsibility report, Chairman Sir Christopher Gent and CEO Dr. JP Garnier assured stockholders, “Our ten corporate responsibility principles set the standard for everyone, since responsible business is only a reality if it is practised by all employees at all times. … We invite you to read this report for more information on all our corporate responsibility principles, and we welcome your comments and suggestions.”

As Holly Martins might say, “Have you ever visited the children’s hospital?”

Robert Cockburn is a writer and a former foreign correspondent who has reported for the Times of London and the BBC.



This site contains copyrighted material the use of which has not always been specifically authorized by the copyright owner. We are making such material available in our efforts to advance understanding of environmental, political, human rights, economic, democracy, scientific, and social justice issues, etc. We believe this constitutes a 'fair use' of any such copyrighted material as provided for in section 107 of the US Copyright Law. In accordance with Title 17 U.S.C. Section 107, the material on this site is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes. For more information go to: http://www.law.cornell.edu/uscode/17/107.shtml. If you wish to use copyrighted material from this site for purposes of your own that go beyond 'fair use', you must obtain permission from the copyright owner.