Unbeatable Prices

LEVERKUSEN/NEW DELHI | | indien

LEVERKUSEN/NEW DELHI (Own report) - Critics of Germany's Bayer Corp. are calling for an investigation into deaths during Bayer's testing of medicines in India. In 2010, alone, at least five people died from side effects in the course of testing the new medicine Xarelto, which the company has hopes of making millions in turnovers. Bayer is carrying out numerous clinical studies in India because the conditions there are more cost effective - "a large reservoir of test persons, unbeatable prices, rapid processing and a deficient supervision," explain observers. The deaths must be clarified as soon as possible. For years, Bayer, in the course of its expansion into Asia, has also been expanding its business relations with India, but with less progress than hoped. The company seeks to attain a one billion Euro company turnover by 2015, which would necessitate the expansion of the pharmaceutical sector into India. The German company, which until recently had denied having problems with side effects in its medical tests, is fervently pushing ahead with its expansion.

Growing Buying Power

The Bayer Corp., located in West Germany's Leverkusen, has been pursuing its expansion in India for years. Already in the fall of 2007, Werner Wenning, Bayer's chairman of the board at the time, announced that the company would "significantly increase its engagement" in India. At that time, the company was hoping for significant growth, particularly in the company's crop science branch, which was already holding a leading market position.[1] Investments, at that time, were also made in special plastics, which were being used in India's growing automobile industry. Particular efforts were aimed at expanding into India's pharmaceutical branch, because India's middle class was growing - in fact, experts calculate that the middle class is larger than 200 million. "The readiness to afford modern medicine" grows "with the increase in buying power," explained Bayer's head of its India department.[2] A growing number in India's middle class is suffering from diabetes, a typical illness of prosperity, and can also afford medical equipment, such as blood self-testers, which Bayer offers at a bargain.

Cheap, Almost no Supervision

Alongside the expansion of its business relations in India, Bayer has also intensified its medical testing in that country. With its reinforcement of patent rights in 2005, New Delhi's government established the prerequisites. The testing branch has boomed in India since. In 2010 alone, it made a US $1 billion turnover with 2,000 pharmaceutical experiments. Bayer's chairman Wenning announced in 2007 the intention of not only expanding the business sector, but the testing sector in India as well. At that time, 6 medicines were already being tested. There have been more since. In numerous poverty stricken countries, particularly India, "a large reservoir of test persons, unbeatable prices, rapid processing and a deficient supervision," are alluring, critics explain.[3] According to specialists, only 20 of the approx. 150 Contract Research Organizations (CROs) doing testing for pharmaceutical companies in India - including Bayer - meet the standards of good clinical practice. There are serious deficiencies, including those concerning the "informed consent," which normally must be signed by whoever agrees to undergo a medical experiment - to permit documentation that the person was informed of the objective and the risks involved in the testing. In India, the widespread illiteracy, alongside poverty, making even the most dangerous jobs seem acceptable, renders the formal obligation of a signature simply worthless.

$5,250 for a Human Life

The medical testing fatality rate in India is correspondingly high, according to statistics published by the ministry in charge - and is continuing to rise along with the increase in experimentation. In reading the statistics, it must be kept in mind that test persons often die of the diseases for which the medication is being tested. Nevertheless, there were repeated fatalities caused by side effects. In India 137 test persons died during the medical experimentation in 2007, in 2008, it was already 288, in 2009, 637 and in 2010 the number rose to 668. According to the Indian administration's statistics, at least 22 of the fatalities in 2010, died not from their diseases, but from the tested medicine. 138 people died in connection with Bayer, five of whom traceably from side effects. Critics assume that the number of undetected cases is much higher - not least of all because of deficient state supervision and because there is no obligation to register clinical studies in India.[4] Totally independent of these facts, Bayer can more easily afford Indian victims than, for example, German. In Germany the Hoechst Corp., for example, had to pay 60,000 Euros indemnity to the family of a test person, who died in the course of medical experimentation. Before 2009, there was no indemnity paid in India, and in 2010, Bayer paid an indemnity on an average of US $5,250 per person.

Xarelto

Bayer's fatal victims of test side effects in 2010, were all caused by a single medicine - Xarelto. The company is hoping that Xarelto, whose stock market price has already been set, will bring billions in returns. However, the company is having problems obtaining a license in western industrialized countries. There is serious apprehension about grave side effects, including, cardiovascular problems or liver damage. In Europe, Xarelto, until now, can only be prescribed for preventing thrombosis following serious orthopedic operations. Bayer seeks to also market it as an apoplectic prophylaxis, and is hoping for a license before the end of this year. The US Food and Drug Administration (FDA) has just licensed the pills as an apoplectic prophylaxis. Thrombosis is rather common, particularly in western industrial societies and is among the most common causes of death. The same holds true for strokes (apoplexy), which, in addition, due to its long-term effects and persistent need to be under doctor's care, is classified as one of the most expensive disorders in western society. Therefore, Bayer's testing, in which people in India are dying, is, above all, benefiting the prosperous populations of the West.

Business worth Billions

Whereas Bayer's critics are now calling for an investigation of the fatalities in India, the company in that country is especially seeking further expansion. By 2015, it seeks to raise its annual returns to at least a billion Euros. In 2009, Bayer had returns of only 400 million Euros - hardly one-fifth of what the company had achieved in neighboring China. Sixty percent of these 400 million Euros was generated by the company's Crop Science sector - already a leader on India's market - and 35 percent, through the plastic sector. Bayer's pharmaceutical sector is still generating a negligible share of returns. At the beginning of the year, Bayer announced its entering a joint venture with India's Zydus Cadila pharmaceutical company to make headway in India. From Bayer's perspective, the victims of its Xarelto testing are not a priority, in light of the billions in its planned business, they are, at best, only of marginal interest.

[1], [2] Bayer will in Indien expandieren; www.handelsblatt.com 23.10.2007. See also Deadly Poison and Mordsgeschäfte (II)
[3] Jan Pehrke: Bayer globalisiert Arzneitests; www.cbgnetwork.org/3568.html
[4] Coordination gegen BAYER-Gefahren: Indien: Todesfälle bei Pharma-Studien; cbgnetwork.org/4110.html