Generic Paxil Suicide Lawsuit

Citizens Commission on Human Rights Award Recipient (Twice)
Humanist, humorist

Thursday, May 29, 2008

Death By Dilution. GSK, Halfan & fake-drug racketeering?

Fascinating story from 2005 over at The American Prospect. It was written by Robert Cockburn, a writer and a former foreign correspondent who has reported for The Times of London and the BBC.

When fakes of a GlaxoSmithKline anti-malarial drug turned up in Africa, authorities assumed the drug giant would want to know. Instead, they learned about a huge, evil trade in fake drugs -- and about an industry that doesn't want the truth to get out.

I really need to publish this story here (not all of it) and highlight some relevant points in red.


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.

Story continues... HERE

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7



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