Part II Deadly Side Effects: New Details Emerge in East German Drug Test Scandal

09/30/2013 10:40

by  Nicola Kuhrt and Peter Wensierski
 

PART II - No Objections to Using East Germans as Guinea Pigs

 

Up to 800,000 Deutsche Marks Per Study

First lobbyists for the likes of Bayer and Schering had to discreetly negotiate with their East German contacts over patient trials. To that end, marketing people from the West had been regularly traveling to the Leipzig Trade Fair since the 1970's, bringing along gifts for their hosts -- based on the requests, large and small, they had previously received from the heads of East German hospitals. Many of their wishes were fulfilled, not out of charity but for business reasons. The companies donated computers and other equipment, and they also invited East German doctors to attend lavish meetings in the West.

Starting in 1983, the Western companies were able to officially submit their offers to a central office. During their visits to *Fehrbelliner Strasse*, the *pharmaceutical representatives offered the East Germans up to 800,000 deutsche marks per study*. Petzold and his comrades at the Health Ministry drummed up the funds for their republic, raising millions for the struggling East German economy. Like a pimp, *their government sold its sick citizens and prostituted the country as a laboratory for the West's clinical trials.

The *dismal condition of the East German healthcare system* was one reason that the Western customers had such an easy job of it. Although East German doctors went to great lengths to improvise as much as possible, citizens faced growing waiting lists for life-saving operations, there was a shortage of effective drugs and necessary treatments were not performed.

Even *Ludwig Mecklinger, the then East German health minister*, had no illusions. In office from 1971 to 1989, he was known for bluntly stating his position, albeit not openly.  *In a 1983 meeting of top East German officials, Mecklinger outlined the extent of the dire problems facing the healthcare system*. Mecklinger died in 1994, but according to documents from his archives, *he feared "growing frustration within the population and among doctors" in light of the state of healthcare, and noted the East Germany had "fallen almost completely behind" international standards*. The country was increasingly behind the curve in all key areas of diagnosis and treatment, Mecklinger wrote, adding that East Germany was inferior to West Germany when it came to mortality rates in almost all age groups in recent years.

Alexander Schalck-Golodkowski, who consistently raised Western capital for the regime in convoluted ways, occasionally managed to come up with injections of funding for hospitals. They were then suddenly showered with gifts of disposable gloves and surgical materials, in the same way people in East Germany could briefly look forward to oranges and bananas during the Christmas season (fruits that were extremely difficult or impossible to get during other times of the year).

But his efforts were far from sufficient to rehabilitate the healthcare system. Mecklinger, Schalck-Golodkowski and a small group of experts discussed ways to address the problem.They knew that human trials were required before a drug could be approved, and they also knew that the West German Federal Health Ministry had tightened its requirements for these trials. After the *thalidomide (sold under the brand name Contergan in Germany) scandal of the 1960's, the public had become far more critical in the West and was taking a more skeptical view of animal experiments and human trials.

The East German officials agreed that such problems would not arise in the German Democratic Republic (GDR). But they *disagreed over how to distribute the hard currency they expected to raise*.Schalck-Golodkowski initially wanted to see 60 percent of the proceeds paid to his Berliner Import & Export Gesellschaft (BIEG), whose profits went directly into the coffers of then East German leader Erich Honecker. Mecklinger preferred to see the money invested in his backward hospitals. After 20 minutes, the meeting ended with *Schalck-Golodkowski and Mecklinger agreeing to split the spoils evenly, paving the way for the advisory office in Prenzlauer Berg to begin its work.

East German Guinea Pigs

A profitable period began for the business partners. Take, for example, *Schering*. On Oct. 15, 1985, *employees of the West Berlin pharmaceutical company, which Bayer acquired in 2006, made a trip to their new testing ground*.

*Even at the border crossing*, executive board member Heinz Hannse and development head Werner-Karl Raff *were given preferred treatment*. They were *greeted in the East by a high-ranking delegation of representatives of the Health Ministry and Charité Hospital, as well as employees of Schalck's BIEG*.

The initial negotiations revolved around a series of tests of Rolipram, a psychotropic drug, a contrast agent called Echosan and Iloprost, a drug designed to treat severe circulatory disorders*. The East German officials had *no objection to allowing their Western partners to use the people of the GDR as guinea pigs*.

During a break, one of the Schering executives took aside the Charit representative, Dietmar S. In a private conversation, the two men discussed *Schering's desire to have even more drugs tested, including nifedipine,* a medication to treat high blood pressure, with which the company hoped to generate substantial profits.

The *Schering representative offered Charit a deal worth six million deutsche marks a year, noting that this amounted to a third of the company's entire budget for clinical trials*. The *GDR, he said, was an attractive business partner for Schering*, and the proposed arrangement could spell *the beginning of even more lucrative deals*. "In our *mutually commercial interest," he added, it would be preferable to leave aside the political issues* involved.

He also had some good news for Charit, he said, namely that *Schering executive board member Hannse had spoken with the then-mayor of West
Berlin, Eberhard Diepgen. Hannse, he explained, had discussed with Diepgen "*the scope of Schering's business plans with the GDR*, so as to
possibly set aside potential political reservations of the CDU/FDP. Berlin Senate (the official name for the city government), or to secure the necessary political backing."

Conflicts and Moral Qualms

Did the West Berlin Senate provide support for patient trials in the East German dictatorship?*"I can no longer recall the exact details," says Diepgen. "If that was the case, we would have treated it as a normal development at the time. We had no reason to review the medical aspects of cases under the jurisdiction of the Federal Health Office."

Stasi reports on conversations among East German doctors highlight the conflicts they faced and the moral qualms they confronted*.

According to these reports, *Christian Thierfelder, the director of research at Charité, sought to explain the generous offer from the West* by saying that, first of all, it offered Schering the opportunity to "*bolster its international standing* with clinical trial reports from Charit, a reputable institution."

Second, Thierfelder argued, *Schering was handicapped by the fact that it "could not perform certain tests in West Germany*, because of the  prevailing public mood there." For this reason, he added, Schering was interested in having trials performed at Charit "* that the press in the West has already portrayed as undignified and inhumane*."

The company, Thierfelder said, apparently had "general ethical problems when it comes to using human beings as guinea pigs." This was *because well-heeled patients in the West were refusing to "submit to such treatments*."

Thierfelder argued that because Bayer and Hoechst had made similar offers recently at the Leipzig Trade Fair, *if the public learned about the trials, the GDR would acquire the dubious reputation of being a "low-cost country" and an "inexpensive proving ground.*"

But *such qualms were apparently overcome*. Representatives of both sides met once again two weeks later, this time at Schering, *where they signed a framework agreement, to be followed by several agreements on individual testing series*.

Fatalities and Snail-Paced Investigations

*In addition to Charit, many other East German hospitals began testing drugs on their patients*. The trials *resulted in several fatalities*, which the participating hospitals were slow to investigate. Some studies had to be discontinued because of serious side effects that had suddenly occurred.

"*I experienced it myself," says Hubert Bruchmüller, 59, from the eastern German state of Saxony-Anhalt.* A former electrician, he was diagnosed with myocarditis when he was 35. "I *might be the only survivor of clinical trials that were performed at the Lostau Chest Clinic in 1989*," he says. His *family doctor had referred him to the hospital* near the eastern city of Magdeburg, he says, "because, as he said, *they had a new drug there for me.*"

The *word "test" wasn't mentioned,* he adds. His doctor, he says, told him that he should take advantage of the opportunity, and that if he did he would have access to the drug in the future. "I wasn't suspicious at all, and I went there full of hope. *Nothing was explained to me, and I didn't have to sign anything*, either."

*Bruchmüller was given*shiny yellow capsules from a small container labeled: "*Cardiac agent, patient No. 030," by Sandoz*. The pharmaceutical company is *part of Novartis today*. When *his roommate*, who received the same treatment and was listed as "*patient No. 029*," collapsed and, according to the medical record, *died of "acute cardiac failure," the test of Sandoz's antihypertensive drug Spirapril was abruptly terminated*.

Apparently *the case of Patient No. 29, as well as that of another fatality, was not investigated*. The only reference to it is a brief comment in the files of the Zentraler Gutachterausschuss für den Arzneimittelverkehr, a board that evaluated adverse drug reactions for the Health Ministry in East Berlin. The minutes of a meeting that took place on March 6, 1990, shortly before the demise of the GDR, included the following remark: "Prof. Dr. Assmann is to be reminded of her duty to provide a statement on the *two fatalities in Lostau*."

*Bruchmüller, who still has his Sandoz pill container with a few pills left in it, paid another visit to Lostau last winter*. He was *permitted to take a brief look at his medical file, but he has since been waiting for months for the copies he requested*.

The *doctors involved in the study in 1989 are now far away, working at private hospitals somewhere in Germany*. "And besides, who is in a position to fight the powerful pharmaceutical companies?" Bruchmüller asks, sounding resigned.

Problems Abound

*Other drug trials also resulted in fatalities*. In *1988 Hoechst, now part of the Sanofi Group*, tested the drug *Trental*, a treatment for poor blood circulation, *in East Germany*.

*Hoechst had the drug tested against a placebo*. The subjects were not told whether they were taking the real drug or the placebo. *Two patients died*. Although the *trial was eventually terminated, the East German clinical investigators took their time doing so*. At a meeting on Feb. 17, 1989, they decided to establish a task force to address problems with the trial, and they also requested a complete list of infusion volumes before taking further action.

Problems were also encountered with *Ramipril*, a drug developed by Hoechst to treat high blood pressure. In the Ramipril trial*, half of the patients were also placed in the placebo group*, which *meant that they were exposed to the risk of stroke or heart attack*. The *doctors treating the patients were also kept in the dark* over which patients received the drug or the placebo.

The *East Germans involved in the business end of the deal were ecstatic. The trial would generate 500,000 deutsche marks in revenue*, and it had "produced the best result to date in this field!" 

 

But *a senior physician at Charit at the time voiced concerns*, saying: "The company wants to demonstrate efficacy and sell the drug." *The Hoechst trial, he told a senior Stasi officer, could "lead to acute hazards to health and even death. And the doctor doesn't even know what's happening,  which prevents him from responding*, that is, if that's even possible anymore and the patient hasn't died yet."  When the *doctor took his case to Petzold* at the advisory office on Fehrbelliner Strasse, who had prepared the agreement with Hoechst, *he was unsuccessful*. The disappointed physician reported "that *others signed the agreement, over the heads of Charit, focusing primarily on the money," which was "unacceptable."*

Drugs Administered to Babies

*Boehringer Mannheim, now owned by the Roche Group*, even conducted *experiments in East Germany* that it would have a hard time explaining
to West Germans. The company tested *erythropoietin* (commonly known as EPO), a substance that has been *abused as a performance-enhancing drug, on "**premature babies**, "*according to 1989 reports. *Thirty preemies*weighing between 750 and 1,500 grams (1.6 to 3.2 lbs.)
were *given the hormone to stimulate the production of red blood cells at Charit*. The study protocol called for administration of the synthetically produced agent at three-day intervals. *The tiny subjects were between four and 25 days old. Today the manufacturer is either unable or unwilling to explain how the drug was administered to the babies*.

Meanwhile, *Bayer was testing nimodipine*, a drug used to improve cerebral blood flow, at the *Central Clinic for Psychiatry and Neurology in East Berlin*. Some of the subjects were *_alcoholics in acute delirium who, as a result of their condition, could not be questioned to obtain their consent*. According to hospital records, the drug reduced their blood pressure and caused perspiration and trembling.

Part 3: The Role of Doctors

*Ulrich Moebius, a doctor who went from being a pharmaceutical manager to a critic of the industry after the Contergan affair, characterizes
these tests as a crime*. "They *could have killed people*," he says. *Bayer rejects the accusations, saying that East German physicians were
the ones who proposed the tests*.

Severely depressed East German citizens were also used in drug trials

Instead of treating patients in acute phases with drugs with demonstrated efficacy in treating their disease, *Charit doctors used them to test two antidepressants known for their severe side effects, levoprotyline and Ludiomil.* The trial was done on behalf of the *Swiss firm Ciba-Geigy, which is now part of Novartis*. Moebius, the co-founder of arznei-telegramm, a German medical journal critical of the pharmaceutical industry, *classifies levoprotyline as one of the so-called dirty drugs*. The *East German tests would not have been possible in Western countries* he says.

But the *East German clinical investigators running the trial almost never detected problems with the patient trials, either because they
could not or would not recognize them*. In response to the sudden cardiac death of a patient who had participated in a trial involving
Roche's drug carvedilol in 1989, they merely concluded that *the patient's death was to be "classified as an event possible within the
context of his illness." What exactly happened was never determined.*

Could the physicians involved at GDR hospitals have recognized the dangers of the drug trials?* Should they have *opposed the Socialist Unity Party (SED) officials' deals with the Western pharmaceutical industry*, and should they *done more to protect the interests of their
patients?*

*Harald Mau developed the pediatric surgery department at Charit*, which he headed until 1983. He later become director of pediatric surgery and eventually was named dean of the hospital. Few people are as familiar with *Berlin's largest hospital*.

*The dictatorial system left research directors and medical directors with no alternatives, he says*. "One mistake, or one objection, *and they would no longer have enjoyed the benefits resulting from the pharmaceutical testing," *says Mau, who retired four years ago. Some gave and others took, he explains, and those who didn't participate with sufficient enthusiasm faced the wrath of their colleagues, because their lack of cooperation  translated into the *loss of benefits for their respective departments*.

It Brings In Hard Currency, So We'll Do It!

*"If we were lucky, the proceeds went directly to the department, and instruments could be purchased. If things didn't go well, the clinic kept the money or it was spent at the Charit level," says Mau.*In the context of *the competitive socialist system*, the hospital administration would announce, at the end of each year, the amount of deutsche marks each department had earned. This meant that *doctors who conducted the studies for Western companies were constantly under pressure to acquire hard currency in competition with one another*. Mau remembers a sentence *often uttered by senior physicians at Charit at the time: "It brings in hard currency, so we'll do it!"*

 

 


{Some things never change. Again, the use of very vulnerable human subjects, most without even an informed consent or even a proxy consent form, including premature babies.This research was not performed in the mid-1940's. It was performed in a major Western country in the 1980's up to the 1990's -- long after the institution of the international ethics guidelines of the Nuremberg Code and the Declaration of Helsinki. How much of this is still going on -- especially in Third World countries? What kind of doctors are these? What kind of drug companies are these? Is this what the free market system means -- and allows? Then what's the difference between that and the socialist or communist systems? Wait until the clinical trials for biosimilar drugs [aka, genetically engineered drugs using synthetic biology and nanotechnology designed by transhumanist-funded international sources get going. Already starting up (as recent emails have documented).(See:http://finance.yahoo.com/news/intrexon-organizes-around-synthetic-biology
-183800666.html
;also, http://www.nanowerk.com/news2/biotech/newsid=30460.php) and http://www.spiegel.de/international/germany/western-drugmakers-tested-medicines-on-unwitting-east-germans-a-899594.html
  Good luck.-- DNI}