an unimaginable story…

Posted on Monday 10 December 2012

East Germany let drugs companys use its citizens as guinea pigs
The East German communist state allowed Western pharmaceutical companies to use its citizens as human guinea pigs for secret clinical trials in return for hard currency, it has been revealed.
Daily Telegraph
By Matthew Day
05 Dec 2012

East Germany made millions of deutschemarks from the trade that ran for six years and only came to an end with the collapse of the socialist state in 1990 despite the fact that some patients died during the trials. The allegations of the use of unwitting human guinea pigs came in a documentary called "Tote und Deaths" Death and Tests which was aired on German television earlier this week. Although the destruction of old East German health ministry files made it impossible to determine the exact number of sick people involved, the documentary estimated that over the years thousands were caught up the deadly testing.

The trade came to light after journalists from the television company ARD were given a jar of red and white pills dating back to 1989. It once belonged to an East German called Gerhard Lehrer who had been given the drug after suffering a heart attack, with doctors assuring him the pills were very effective. Despite taking them, Mr Lehrer died.

His widow kept the jar and years later had the pills tested, only to find they were a placebo. ARD journalists found a file in the East German archives with a number corresponding to that on the jar of pills, and that lifted the lid on the practice of trading patients for money. In the early 1980s the East German economy was suffering and the growing number of shortages also included medical supplies. "There were pharmacies which could no longer provide 20 per cent of needed drugs," Christoph Friedrich, a pharmaceutical historian from the University of Marburg, told the documentary makers, "and that shortage extended to hospitals.".

Salvation came in 1983 when a secret meeting of health officials decided to allow Western pharmaceutical companies to test drugs in East Germany. For the Western companies using East Germans as guinea pigs circumvented the rigorous testing regulations imposed upon them following the 1960s thalidomide scandal. By 1988 165 test programmes were being carried out across the country..

In 1989 Hubert Bruchmuller was admitted to a specialist heart hospital in the town of Lostau and was given a new drug called Spirapril. During his stay at the hospital he saw one patient die from a heart attack in the bed beside him, and other patients in the same ward, he said, just seemed to disappear. Out of the 17 tested on at Lostau, six died. The ARD journalists could find no documents indicating that any of the patients were aware that they were part of a clinical trial. The pharmaceutical firms involved, some of which have since changed their names and company structures, said they had no knowledge of the testing.
Like anyone reading these stories, my second thought was "which companies?" Surfing through the German and British sites reporting this story, I could only find two of the Companies involved, now mergered out of existence – Sandoz [>Novartis] and Hoechst [>Aventis>Sanofi-Aventis]. Apparently this went on throughout the 1980s and ended when the Berlin Wall came down in 1990. Another report:

Former Communist East Germany secretly sold its citizens to western pharmaceutical companies to use as human guinea pigs in drug trials. Tens of thousands of sick people in the former German Democratic Republic were treated with medicines not approved in the West to see how effective they were. Details of the top secret project have been unearthed in the files of the Stasi secret police in Berlin. The communist regime profited with millions in hard currency. But the human cost was high with dozens killed through side effects of drugs which had bypassed the normally stringent testing procedures demanded by western democracies. Even worse, some patients received placebos – pills that did nothing at all – to gauge how they responded in comparison to others who were given proper medication.

The practice was exposed by journalists Stefan Hoge and Carsten Opitz and screened this week in Germany in a disturbing documentary entitled ‘Test and Dead’. The Stasi files – miles and miles of yellowing paperwork which the hated secret police of East Germany failed to destroy when the country imploded in 1989 – revealed details of how it became one of the most important testing arenas for western drug companies. The conspiracy involved the state, doctors and western big pharma firms.

GDR leaders were happy to implement the programme in a land which excelled only in shortages. ‘There were pharmacies which could no longer provide 20 percent of needed drugs,’ said pharmaceutical historian Christoph Friedrich from the University of Marburg. ‘And that shortage extended to hospitals.’

The thalidomide scandal at the beginning of the 1960′s intensified the criteria for medical testing across the western world, including in West Germany. New regulatory requirements for market approval forced the manufacturer to conduct ever larger clinical trials of their drugs in large groups of patients. East Germany, for cold, hard cash, was willing to provide the guinea pigs – although they would never know that they formed part of a huge experiment.

‘A secret Conference with politburo Central Committee members responsible for health care provided the stage for a momentous deal in the spring of 1983,’ said historian Friedrich. ‘At selected hospitals, doctors from western pharmaceutical companies were able to perform clinical tests of non-approved drugs. ‘Paperwork in the Stasi files shows that western drug corporations signed contracts with a GDR foreign trade company. From 20 tests in 1983 there were 165 underway in 1988.

‘The researchers could find no documentation in the Stasi files, or the records of the former East German Ministry of Health, showing that patients knew they were in fact being used as test models. The TV programme could find no-one in western big pharma companies who had any idea about the secret testing programme, said Opitz.
I wrote the journalists,Stefan Hoge and Carsten Opitz, and Professor Friedrich at the University of Marburg inquiring about the Companies. I hope they respond. This is such an unimaginable story. I don’t mean the GDR’s Stasi. We’re used to their atrocities. I mean that western pharmaceutical companies would participate in such a scheme only 40 years after the Nuremberg Trials where human experimentation was a front burner issue alongside the Holocaust. An unimaginable story…
  1.  
    December 10, 2012 | 6:27 PM
     

    Pharma is doing exactly the same thing in third-world countries now.

  2.  
    Stan
    December 10, 2012 | 6:59 PM
     

    The just released 2013 pharmaceutical Industry PR slogan “evil is, as evil does”

  3.  
    annonymous
    December 10, 2012 | 10:21 PM
     

    http://www.nytimes.com/2012/09/27/business/global/russians-eagerly-participating-in-medical-experiments-despite-risks.html

    NOT equivalent to what is being described for the drug companies involved with the East German studies. However, if the latter is in any way a representative example of pharmaceutical company behavior when given much freer reign by a government then that is extremely concerning. I share your belief that this is the most important aspect of the story.

  4.  
    annonymous
    December 10, 2012 | 10:31 PM
     

    Not sure what to make of this from that article:
    “But there have been strange results. In 2007, an F.D.A. official wrote that the agency approved Eli Lilly’s top-selling antipsychotic drug Zyprexa for use by adolescents based on the results of a Russian test, even though trials in the United States showed the drug had no effect. Why tests differed in Russia and the United States was never explained.”
    http://www.druglib.com/trial/98/NCT00051298.html

    http://www.datamonitor.com/store/News/eli_lilly_strike_two_for_novel_schizophrenia_drug?productid=E02CD019-8ECE-435F-A6DF-5B979E655A87
    http://www.datamonitor.com/store/Browse/?Ntt=olanzapine

  5.  
    December 10, 2012 | 11:44 PM
     

    annon,

    Remarkable! Worth chasing down…

  6.  
    annonymous
    December 11, 2012 | 2:29 AM
     

    Turns out this has already been reported 5 years ago:
    http://www.pharmalot.com/2007/09/zyprexa-to-win-fda-approval-for-teens/

    What is disconcerting is if you google:
    fda russia olanzapine
    and look at the second result which is a pdf titled UCM177119 and look at slide 102 and the placebo response.
    The link at pharmalot to Laughren’s approval (and his commentary justifying this) no longer works. But this one does:
    http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM262050.pdf

    Would be interested to see what you come up with if you find it worth your time to bore into those slides and Laughren’s comments.

  7.  
    annonymous
    December 11, 2012 | 2:34 AM
     

    “There also may have been less competition for patients than is the case in the US. There are numerous studies ongoing in the US, and routine treatment is likely also more readily available in the US than in Russia. These same factors may also explain the different results. If difficulty in recruitment in the US sites led to enrollment of a more heterogeneous group of subjects, this could have led to a higher placebo response rate. It is possible that the Russian patients were the more representative schizophrenic patients who typically have very little response to placebo. There is also the expressed concern about relying primarily on non-US data for an approval action. Although I agree this is generally a concern, I think it is more a concern for an initial claim than it is in this case, where we already have a very strong prior belief that olanzapine is an effective treatment for schizophrenia, based on an abundance of positive data in adults. In summary, while I agree this geographic discrepancy is a concern, I do not think it is, by itself, a sufficient justification for a nonapproval action, when the trial is positive overall on the primary analysis and on the MMRM. Nevertheless, we will ask the sponsor to further address our concern about this discrepancy.” – Laughren

  8.  
    annonymous
    December 11, 2012 | 3:05 AM
     

    Something seems strange about the early discontinuations for lack of efficacy in those slides in relation to the LOCF data on slide 102, but I cannot put my finger on it. Slide 9 has the study design. They had a 2-14 day washout and 88.6% of the placebo group had been on one or more antipsychotic meds. Slide 34 lists a number of studies. Slides 41 and 58 are maybe worth a look. There is slide 89. Not sure the difference between 91 and 102.

  9.  
    Allen Jones
    December 11, 2012 | 9:53 AM
     

    I thought I was well past the capacity tio be shocked by drug industry behavior…I was wrong……Horrible.

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