On the 15th May 2008, after a long battle, Bayer was finally forced to withdraw its Trasylol drug from the market. If they had done so when they first knew it was dangerous, thousands of lives could have been saved. This is the latest instalment in the history of a company steeped in controversy; one in which profit has always been made at the expense of people.
Bayer AG was founded in Germany in 1863. In 1898 they were responsible for introducing heroin to America as The Sedative for Coughs and continued to market it after being aware of its damaging effects. As we shall see, this is a recurrent theme of Bayer’s practises.
In World War I, Bayer manufactured poisonous gasses used in the trenches such as chlorine gas and mustard gas. During World War II it became part of IG Farben, a conglomerate of German chemical industries which formed the financial core of the Nazi regime and used slave labour from the Birkenau concentration camp to produce its products. One of Farben’s developments was Zyklon-B, used by the Nazis to gas victims in those same camps.
Bayer executive Fritz ter Meer was sentenced to seven years in prison by the Nuremberg War Crimes Tribunal for experimenting on prisoners. During his trial, in reference to the experiments he said, “concentration camp prisoners were not subjected to exceptional suffering, because they would have been killed anyway.” He was made head of the supervisory board of Bayer in 1956, after his release.
Bayer continued to grow, becoming the third largest pharmaceutical company in the world. In the mid-1980’s they sold a product called Factor VIII concentrate, which can stop or prevent bleeding in people with haemophilia. Several companies, including Bayer, were involved in selling Factor VIII which had been discovered to have been infected with HIV. In the United States, AIDS was passed on to thousands of haemophiliacs, many of whom died, in one of the worst drug-related medical disasters in history.
However it wasn’t until 2003 that the New York Times revealed that Bayer had continued producing and selling this infected product to Asia and Latin America after February 1984 when a safe product was available, in order to save money.
‘‘These are the most incriminating internal pharmaceutical industry documents I have ever seen,” reported Dr. Sidney M. Wolfe in the Times, who as director of the Public Citizen Health Research Group had been investigating the industry’s practices for three decades.
In 2001 Bayer had to recall its anti-cholesterol drug Baycol/Lipobay due to it causing rhabdomyolysis, which results in severe pain and potential kidney failure. Germany’s health minister, on 25 August 2001, accused Bayer of sitting on research documenting Baycol’s lethal side-effects for nearly two months before the government in Berlin was informed. Baycol has now been linked to over 100 deaths and 1,600 injuries.
Partly in response to its problems with Baycol, and the resultant plummeting of its profits, Bayer bought the rival crop sciences unit of French company Aventis in October 2001. This was at the height of the push for GM crop research in Europe. Bayer CropScience, the new subsidiary, was the focus of a concerted direct action campaign in the U.K. from 2003 – 2005. On 9th November 2004 Bayer CropScience removed the last 2 GM crop varieties still in the approval process for the UK national seed list. This was the final nail in the coffin for the commercial growing of the first generation of GM crops in the UK.
Unfortunately the achievements of anti-GM activists in U.K. were not able to be replicated abroad. Currently, three lawsuits have been filed against Bayer CropScience in the U.S., alleging that Bayer knew non-GE rice could become contaminated with its Liberty Rice Link by a variety of means including cross-pollination, storage, transportation, etc. and that Bayer failed to prevent their unapproved rice from entering the food chain.
Bayer pushed Trasylol on to the market in 1993. Five years earlier Dr. Juergen Fischer, director of the Institute of Experimental Medicine at the University of Cologne, had already found severe kidney damage in animals given Trasylol. Dr. Fischer informed Bayer, and was surprised to note the manufacturer’s dis-interest in his findings. Fischer said, “I felt that Bayer wasn’t interested to examine these side effects.”
Over the next 15 years Bayer aggressively marketed Trasylol until it was used in one third of all cardiac operations in America and reportedly given to over 4 million patients worldwide.
The Trasylol treatment retails for ten times the $150 cost of the other two safe alternative drugs available. Trasylol sales in 2006 were in excess of $600 million. This was a large contributing factor in Bayer’s $7 billion earnings in 2007. For the whole of 2007, Bayer’s net profit nearly tripled on 2006 — fuelled by increased sales of pharmaceuticals.
Dr. Mangano published a large study of over five thousand patients in the New England Journal of Medicine in January 2006 highlighting Trasylol’s risks.
This prompted the FDA to arrange a meeting, eight months later, with Bayer. In response Bayer commissioned a study by Harvard professor Dr. Alexander Walker to counter Mangano’s. However when Walker looked at the records of nearly 70,000 patients he concluded, in agreement with Mangano, that Trasylol had an elevated risk of death and acute renal (kidney) failure. The New York Times reported that during testimony during the subsequent meeting in September 2006 Bayer failed to reveal their studies findings.
Bayer and the FDA continued to allow the drug to be used for another two years. Dr. Mangano comments : “Between my study and November 5, when it was taken off the market, there were approximately 431,000 patients who received the drug. As I calculated, 22,000 lives could have been saved. It’s about a 1,000 lives saved per month delay in taking that drug off the market.”
It is only the recent BART study published on the 15th May 2008 by the New England Journal of Medicine that has finally forced Bayer to withdraw it from the market. This study had to be halted in late October 2007 due to deaths from acute renal failure brought on by Trasylol.
Yet still Bayer are hedging their bets and hope to reintroduce its use. Staci Gouveia, a Bayer spokeswoman stated that Bayer, “will work with health authorities to determine what impact, if any, the BART data and any other new data will have on the benefit-risk profile of Trasylol.” 78 lawsuits have been filed in the United States against Bayer concerning Trasylol which they have said they will vigorously defend against. It looks like Bayer has no intention of changing their tactics, after over a centenary of profiteering, malpractice and denial.
- ‘60 Minutes’ episode entitled One Thousand Lives a Month from CBS News
- Corporate Watch – an exhaustive list of Bayers harmful actions
- Coalition Against Bayer Dangers – German based campaign group
- Joseph Borkin The Crime and Punishment of I.G. Farben (1978) Free Press New York