Below is new information on how Grunenthal (in Germany) knew of thalidomide’s harmful effects on foetuses before the medicine was ban in 1961. This evidence dismantles the long-held belief that birth defects were an “unforeseeable tragedy” and that Grunenthal’s ”actions were consistent with the state of scientific knowledge and prevailing standards of the 1950s”. As the article suggests, this was a conscious effort to cover-up essential information for 50 years. The article includes two links to court documents and important correspondence leading up to the 1961 ban. Thalidomide victims may see justice but Grunenthal is vociferously defending lawsuits.
The 50-year global cover-up
www.canberratimes.com.au/national/the-50year-global-coverup-20120725-22r5c.html
SECRET files reveal the German maker of thalidomide ignored and covered up repeated warnings that its drug could damage unborn babies.
The Age has obtained excerpts of never-before-published files from the archives of pharmaceutical giant Grunenthal which detail explicit warnings the company received about its drug’s potential to harm foetuses well before it was withdrawn from sale in late 1961.
images.theage.com.au/file/2012/07/25/3486637/thalid1.pdf?rand=1343218296209 images.theage.com.au/file/2012/07/25/3486947/thalid2.pdf?rand=1343218286415
An estimated 10,000 babies worldwide – including hundreds in Australia – were born in the late 1950s and 1960s with severe physical deformities because their mothers had taken thalidomide drugs, which were marketed as a safe sedative and remedy for morning sickness.
The Grunenthal files expose a 50-year global cover-up and demolish the company’s long-held position that the scandal was unforeseeable tragedy and that its ”actions were consistent with the state of scientific knowledge and prevailing standards of the 1950s”.
The files reveal that for at least two years before the drug was banned in late 1961, German medical professionals had told Grunenthal staff of concerns that children’s deformities were caused by women taking thalidomide during pregnancy.
Between 1959 and 1961 – while the drug was still being marketed as safe – Grunenthal employees and their families began having deformed babies.
In one company file, it is noted that ”eight families, which, as dependants of the Chemie Grunenthal Company, during the years between 1959 until 1961, had had deformed children”.
Rather than act on the internal warnings, Grunenthal simply told concerned doctors there was no information to suggest the drug was unsafe.
The Grunenthal documents have come to light after they were lodged in the Victorian Supreme Court by Slater & Gordon lawyer Michael Magazanik in support of a compensation claim by Melbourne thalidomide victim Lynette Rowe.
Ms Rowe, in a case led by prominent plaintiff lawyer Peter Gordon, last week secured a multimillion-dollar payout from UK company Diageo, which bought thalidomide distributor Distillers in 1997.
Diageo is considering settlements with up to 130 other thalidomide victims in Australia and New Zealand. But Grunenthal continues to deny any culpability and is aggressively defending lawsuits.
The Grunenthal files include a statement by German pharmacist Friedrich Koch revealing that he wrote to the firm in late 1960, having spoken to a mother who took Contergan – a brand name for thalidomide – during pregnancy and whose child was born with internal injuries.
”After my discussions with (a patient), I felt compelled to write a letter to the company Grunenthal on 24 November 1960. In this letter … I inquired whether a child could develop injuries if the mother had taken Contergan regularly during pregnancy.
”The thought that medication might possibly affect a foetus … did not seem absurd to me, but rather worth investigating,” Mr Koch wrote.
Grunenthal wrote back to Mr Koch enthusiastically giving the drug the all clear. ”Based on the contents of the letter, I was then able to tell the parents that according to the company, their babies injuries were not caused by the mother taking Contergan during pregnancy,” Mr Koch’s statement says.
”Naturally I presumed that the scientists in Stolberg [Germany] had already looked into the problem of their Contergan breaking through the foetus or that they would at least look into it after receiving my letter.”
A year before Grunenthal assured Mr Koch the drug was safe, the firm was contacted by a German medical practitioner, Dr K, with similar concerns.
Dr K’s statement reads: ”I can recall with certainty that I made a possible connection between Contergan and my son’s deformities as early as 1959.
”In the same year, my wife and I had discussed this problem with [Grunenthal employee] Dr Mannheim at various times … He always explained that he just could not imagine thalidomide causing these types of injuries … I established at least a further two malformations during 1959 which I also connected to Contergan.”
Several files reveal Grunenthal was receiving an increasing number of queries about the drug’s potential to harm babies at the same time it was telling the public it was safe.
An internal document dated February 1961 – almost a year before thalidomide was banned – poses a question about its potential to effect the foetus. Another document includes a reference to Grunenthal being told that thalidomide was ”known as an abortive drug”.
A March 1961 document says animal testing might shed light on the effect of thalidomide on a foetus while also acknowledging that the company had no idea what this impact could be. ”[We have] no experiences ourselves
regarding [thalidomide] and pregnancy,” the March 1961 memo states.
Around this time, Grunenthal sales representatives wrote confidential memos to the firm about what doctors had told them about possible impacts of the drug. A February 1961 letter from a doctor working in sales for Grunenthal states that his ”main objective” in responding to such concerns was ”once again … to generate general interest and cause confusion”.
An April 1961 memo from another Grunenthal sales representative deals with the drug’s potential to cause nerve injury, finding that in one medical ward there were ”20 clear Contergan [thalidomide] allergies and 2 cases of polyneuritis”.
”On the psychiatric wards with huge use of 271 [thalidomide] no side effects at all (maybe the idiots are happy when they are tingling!),” the sales representative noted.
Another file reveals that in the months before July 1961, a German doctor quizzed Grunenthal about the potentially harmful effects of the drug during his wife’s second pregnancy, given she had previously miscarried after taking Contergan.
The doctor’s wife gave birth to a severely deformed child in July 1961 and he immediately suspected ”the potentially harmful effect of Contergan on the child”.
In mid-1961, a Grunenthal doctor told a fellow employee ”that in regard to Contergan, significantly more severe injuries than those already known were to be anticipated in his opinion”.
Yet another company doctor also confidentially flagged concerns, telling a Grunenthal meeting that the firm ”needed to investigate the diaplacental transfer of [thalidomide] by way of animal test to determine the possibility of damage to the foetus.”
According to one of Mr Magazanik’s affidavits, ”by May 1961, Grunenthal knew that its own medically trained staff had ‘a very real fear of [thalidomide] side effects’ and were refusing to use thalidomide drugs within their own families.”
By late 1961, when United States regulators had refused to licence thalidomide due to safety concerns, Grunenthal’s internal files reveal a growing acknowledgment inside the company that there may be a serious problem with its drug.
In September 1961, the company wrote to a medical expert querying if it could draw on his expertise on the ”effects of medication on the foetus”.
But no tests were done in the last six months of 1961, despite further concern expressed to Grunenthal that their drug might be harming or killing babies.
It wasn’t until November 1961 that the company finally moved to ban the drug after getting now well-known reports by Dr Widikund Lenz and Australian obstetrician William McBride about the links between the epidemic of birth defects and thalidomide.
The company at this time began formulating its position that it was not to blame.
But privately, Grunenthal’s own lawyers had their doubts about aspects of the company’s behaviour, including its response to hundreds of reports of nerve damage caused by thalidomide which prompted them to warn it was facing ”a dangerous and uncomfortable situation so injurious to the reputation of the organisation”.
Abstract of the PhD dissertation defended by João Carapinha on July 18, 2012.
The Universal Declaration of Human Rights affirms an individual’s right to health and essential medicines are a crucial element in improving health. Part of South Africa’s extensive legislative framework promotes medicines access and use, and since the first democratic elections in 1994, key Constitutional Court cases have shaped health as a human right. The World Health Organization has called for the inclusion of a gender perspective in national essential medicines programs. However, little is known on gender and medicines among patients with chronic conditions in low- and middle-income countries, including South Africa. There is no empirical evidence that describes the contextual (neighborhood) and compositional (individual) effects on medicines use among men and women with chronic conditions in South Africa. No analysis is available on whether South Africa’s medicines policy integrates a gender perspective or whether it complies with international human rights law.
A mixed-methods approach was used to investigate gender disparities in medicines access and use among adults with chronic conditions in South Africa. A multidimensional conceptual framework theorized, from a gender perspective, the influence of various individual and neighborhood factors on medicines access and use. A systematic literature review presented a thematic summary of gender studies on medicines access and use among patients with HIV/AIDS and TB in low- and middle-income countries. South Africa’s 2003 Demographic and Health Survey data were examined, using a cross-sectional design to assess, from a gender perspective, the influence of individual and neighborhood factors on medicines access and use with multilevel logistic regression models. An analysis of South Africa’s medicines policy identified whether a gender perspective was included and benchmarked current legislation with international human rights law.
Existing evidence focuses mostly on gender and access to medicines and adherence among HIV patients. Contrary to prevailing hypotheses, most studies reported no statistically significant gender differences for either class of outcomes. The few studies that did document gender differences took no clear direction, and favored women slightly more than men. In South Africa, among adults with a chronic condition, men are significantly less likely to use medicines compared to women after adjusting for all individual- and neighborhood-level predictors (Men, Predicted Probability (Pr) = 0.460 vs. Women, Pr = 0.533, p = 0.001), in part because men are significantly less likely to visit any health care facility compared to women (Male β = – 0.467, p < 0.001). Men in the middle and fourth quintiles of neighborhood socioeconomic status were significantly less likely to use medicines compared to women (Middle, Men, Pr = 0.348 vs. Women, Pr = 0.562, p = 0.000; Fourth, Men, Pr = 0.433 vs. Women, Pr = 0.535, p = 0.045). South Africa’s medicines policy is gender-blind at best, and if left as is, is likely to create or perpetuate rather than redress gender differences in access to and utilization of health care facilities and medicines. South Africa has the obligation under international human rights law to ensure that such facilities can be accessed by men and women on a non-discriminatory basis.
Further research on medicines availability, affordability, adequacy, and acceptability is required to affirm or negate hypotheses that gender differences exist along these dimensions. Future research on chronic conditions should use medical records, longitudinal data, investigate health-seeking behavior, particularly among men, and experiment with different definitions for neighborhood. South Africa’s medicines policy needs to be reviewed and realigned with the minimum core obligations contained in General Comment 14 (International Covenant on Economic, Social, and Cultural Rights). Gender-sensitive indicators based on a right to health conceptual framework will be needed to develop a body of evidence and to integrate such information into the policy making process.
From left to right, Dr. João Luis Do Nascimento Fernandes Carapinha, Prof. Dennis Ross-Degnan, Prof. Theresa Osypuk and Prof Brook Baker (Chair of the Dissertation Committee).
