Date: May 23, 2003
Abstract: A division of the pharmaceutical company Bayer sold millions of dollars of blood-clotting medicine for hemophiliacs - medicine that carried a high risk of transmitting AIDS - to Asia and Latin America in the mid-1980s while selling a new, safer product in the West.
The Bayer division, Cutter Biological, introduced its safer medicine in late February 1984, as evidence mounted that the earlier version was infecting hemophiliacs with HIV.
Yet for more than a year, it continued to sell the old medicine overseas, prompting a United States regulator to accuse Cutter of breaking a promise to stop selling the product.
By continuing to sell the old version of the life-saving medicine, documents show, Cutter was trying to avoid being stuck with large stocks of a product that was increasingly unmarketable in the US and Europe.
Yet even after it began selling the new product, the company kept making the old medicine for several months more. A telex from Cutter to a distributor suggests one reason: the company had several fixed-price contracts and believed the old version would be cheaper to produce.
Nearly 20 years later, the precise human toll of these marketing decisions is difficult, if not impossible, to document.
But in Hong Kong and Taiwan alone, more than 100 hemophiliacs contracted HIV after using Cutter's old medicine, records and interviews show. Many have since died. Cutter also continued to sell the older product after February 1984 in Malaysia, Singapore, Indonesia, Japan and Argentina, records show.
"These are the most incriminating internal pharmaceutical industry documents I have ever seen," said Dr Sidney Wolfe, who as director of the Public Citizen Health Research Group has been investigating industry practices for 30 years.
In a statement, Bayer said that Cutter had "behaved responsibly, ethically and humanely" in selling the old product overseas. Cutter had continued to sell the old medicine, it said, because some customers doubted the new drug's effectiveness, and because some countries were slow to approve its sale.
"Decisions made nearly two decades ago were based on the best scientific information of the time and were consistent with the regulations in place," the statement said.
The medicine, called Factor VIII concentrate, essentially provides the missing ingredient without which hemophiliacs' blood cannot clot. By injecting themselves with it, hemophiliacs can stop bleeding or prevent bleeds from starting; some use it as many as three times a week. It has helped hemophiliacs lead normal lives.
But in the early years of the AIDS epidemic, it became a killer. The medicine used pools of plasma from 10,000 or more donors, and since there was still no screening test for the AIDS virus, it carried a high risk of passing along the disease; even a tiny number of HIV-positive donors could contaminate an entire pool.In the US, AIDS was passed on to thousands of hemophiliacs, many of whom died, in one of the worst drug-related medical disasters in history. While admitting no wrongdoing, Bayer and three other companies that made the concentrate have paid hemophiliacs about $US600 million ($900 million) to settle more than 15 years of lawsuits (SMH, 2003).
Title: German Drug Firm Makes First Apology For Thalidomide
Date: September 2, 2012
Source: Fox News
Abstract: The German manufacturer of a notorious drug that caused thousands of babies to be born with shortened arms and legs, or no limbs at all, issued its first ever apology Friday - 50 years after pulling the drug off the market.
Gruenenthal Group's chief executive said the company wanted to apologize to mothers who took the drug during the 1950s and 1960s and to their children who suffered congenital birth defects as a result.
"We ask for forgiveness that for nearly 50 years we didn't find a way of reaching out to you from human being to human being," said Harald Stock. "We ask that you regard our long silence as a sign of the shock that your fate caused in us."
Stock spoke in the west German city of Stolberg, where the company is based, during the unveiling of a bronze statue symbolizing a child born without limbs because of thalidomide.
The drug, which was sold under the brand name Contergan in Germany, was given to pregnant women to combat morning sickness but led to a wave of birth defects in Europe, Australia, Canada and Japan. Thalidomide was never approved for sale in the United States.
Gruenenthal settled a lawsuit in Germany in 1972 - 11 years after stopping sales of the drug - and voiced its regret to the victims. But for decades the company refused to admit liability, saying it had conducted all necessary clinical trial required at the time.
Stock reiterated that position Friday, insisting that "the suffering that occurred with Contergan 50 years ago happened in a world that is completely different from today" and the pharmaceutical industry had learned a valuable lesson from the incident.
"When it developed Contergan Gruenenthal acted on the basis of the available scientific knowledge at the time and met all the industry standards for the testing of new drugs that were known in the 1950s and 1960s," he said.
A German victims group rejected the company's apology as too little, too late.
"The apology as such doesn't help us deal with our everyday life," said Ilonka Stebritz, a spokeswoman for the Association of Contergan Victims. "What we need are other things."
Stebritz said that the 1972 settlement in Germany led to the creation of a (EURO)150 million fund for some 3,000 German victims, but that with a normal life expectancy of 85 years the money wasn't enough. In many other countries victims are still waiting for compensation from Gruenenthal or its local distributors.
Thalidomide is still sold today, but as a treatment for multiple myeloma
and leprosy (Fox News, 2012).
Title: Czech Kiosk Liquor Ban After 16 Die Drinking Bootleg Spirits
Date: September 12, 2012
Abstract: The Czech government on Wednesday banned hard liquor sales by street vendors after a 16th person died from drinking bootleg vodka and rum containing methanol, in the country's worst case of alcohol-related deaths in decades.
The government has imposed the ban indefinitely on the market stalls and street kiosks that have licences to sell hard liquor. They are common in some Czech towns and often sell vodka, rum and whisky in tiny plastic cups, alongside sandwiches and other food.
Such a large number of alcohol-related deaths are rare in the central European state of 10.5 million people, although state and industry officials have estimated that illegal alcohol sales have been on the increase and account for 10-20% of the market.
Eight more deaths were reported on Wednesday. And at least 24 people remained in hospital, said Stepanka Zatloukalova, a police spokeswoman.
Police took a 36-year old man into custody on suspicion of distributing tainted liquor in the Moravian-Silesian region, 217 miles east of Prague, where the first deaths happened at the weekend.
A second man was also detained in Zlin, a neighbouring region.
The health ministry has carried out 410 checks in bars and restaurants in nine of the country's 14 regions.
Officials found 70 cases where liquor did not have proper documentation, such as a customs or tax stamp, said Michal Schuster, a government spokesman (Guardian, 2012).
Title: FDA Issues Warning About Intestinominica Due To Chloramphenicol Content
Date: September 19, 2012
Abstract: The Food and Drug Administration (FDA)issued a safety warning Tuesday on a drug product manufactured in El Salvador and marketed as a treatment for infectious diarrhea and acute gastrointestinal infections.
The drug, Intestinominica, contains the antibiotic chloramphenicol, a drug linked to dangerous blood disorders. The FDA reports that oral forms of chloramphenicol were formally withdrawn from the United States market in July 2012 due to the risk of serious and life threatening injuries.
In addition to chloramphenicol, the ingredients in Intestinominica include other antibiotics such as Neomycin, which has its own potential for adverse side effects.
According to the FDA press release, Intestinomicina is labeled primarily in Spanish and lists the ingredient as “chloramfenicol palmitato,” or chloramphenicol in English, on the label. It can be found in tablet and liquid forms and is manufactured by Laboratorios Lopez. The product has been found in international grocery stores in the United States that feature South and Central American specialty foods and products.
Chloramphenicol has been linked to various bone marrow toxicities that affect the production of blood cells.The FDA says consumers who have purchased this product should immediately stop taking it and consult with a health care provider (Examiner, 2012).