Press Release, March 26, 2012
Coalition against BAYER Dangers (Germany)

BAYER: Trial-related deaths in India

Countermotion to shareholder meeting on April 27 / full text on BAYER website

BAYER is carrying out an ever increasing number of dangerous drug trials in poor countries, because they offer a large reservoir of test subjects, low prices, fast procedures and little supervision by the authorities. In India alone, there have been at least 138 fatalities as a result of BAYER's drug trials on humans in the last four years. The Board of Management bears responsibility for this. The Coalition against BAYER Dangers has introduced a countermotion to the upcoming shareholder meeting and demands that the Board of Management not be ratified. The motion will be discussed in the meeting on April 27.

More and more pharmaceutical studies are being shifted to emerging countries. India in particular is attractive because of the low costs, the population's knowledge of English, the vast number of test subjects and lax controls by the authorities.

Currently, western companies are having some 1,900 clinical studies carried out in India with 150,000 test subjects, for which they pay around half a billion euros a year. At the same time, the number of victims is rising from year to year: according to the Indian Health Ministry, more than 1,700 test subjects have died in the last four years.

Most of these test subjects are extremely poor and illiterate. In many cases, the declarations of consent are signed by third parties. Very few of the test subjects are aware of the risks they are taking. The ethics committees responsible for monitoring the trials often only exist on paper.

Philipp Mimkes, spokesperson of the Coalition against BAYER Dangers: “Pharmaceutical studies in poor countries must be performed to the same standards as in Europe or the United States, and the victims or their surviving dependents must receive the same level of damages. This is the only way to make cheap, dangerous studies unattractive.”

The BAYER Group has carried out tests on humans in India for many years. BAYER has currently commissioned studies there for the cancer drug Nexavar, the eye medicine VEGF, and the hemophilia drug Kogenate. Trials with the impotence treatment Levitra, the controversial thrombosis product Xarelto, the diabetes drug Glucobay, the hormone coil Mirena, and the X-ray contrast agent Gadovist have recently been concluded. BAYER also carries out human trials in other countries with large poor populations such as Colombia, Pakistan, Moldova, the Philippines and China.

According to the Indian Ministry of Health, at least 138 test subjects have lost their lives in studies commissioned by BAYER during the last four years. Four test subjects died from the side-effects of Xarelto alone. BAYER has paid the surviving dependents damages of just USD 5,250 dollars – in Europe and the United States, the damages in such cases can run into millions of dollars.

Experts consider the official figures to be far too low. Dr. Chandra Gulhati from the journal Medical Specialties, which has been documenting this development for many years, says: "The numbers are much higher because most of the deaths are not even reported. The relatives do not know that the deceased persons were taking part in a study. No investigations are carried out and no post mortem is performed to establish the cause of death."

Even if the official data are incomplete, the figures from the Indian Government clearly contradict the statement made by former BAYER boss Werner Wenning at the Annual Stockholders' Meeting 2010, when he said there had been no serious incidents during clinical studies in India.

The Coalition against BAYER Dangers therefore demands clarification of all the incidents that have occurred during BAYER's drug trials. It wrote to the new BAYER CEO Marijn Dekkers as follows:

We demand that you disclose all the relevant data on clinical studies performed for the BAYER Group in India over the past five years. For each study, please state individually:

=> Which drug was used? In which amount was it administered?
=> Who was commissioned to conduct the trial? Where were the tests conducted?
=> How many test subjects took the drug over which period of time?
=> Which side effects occurred with which frequency? How many deaths occurred?
=> What compensation was paid to next of kin and aggrieved parties?
=> Why does BAYER conduct so many studies in India?
=> Which precautionary measures are taken to avoid further problems?

Despite the great public interest, BAYER has not replied to the letter.

In addition, BAYER is contravening the Helsinki Declaration, in which the World Medical Association set binding standards for clinical studies. Among other things, this states: "In medical research, the well-being of the individual test person must have priority over all other interests." BAYER is also breaching the requirement of this declaration that experiments on disadvantaged persons must always benefit the persons involved, and that, on completion of the trials, the test subjects have a right to continue receiving the drugs. Neither of these is the case in India or other emerging countries.

The Board of Management bears responsibility for the irregularities described here. Its actions should therefore not be ratified.

more information:
=> Countermotions to Shareholder Meeting on Bayer website (“download”)
=> The Independent: How drugs companies exploit Indian 'guinea pigs'
=> Open letter to the BAYER board