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Nazi war crimes and medicine 50 years on
THE LANCET
POLICY AND PEOPLE
Canadians inquire into drug licensing
A
newly created public-advocacy group charges that Canada’s drug approval process has become so lax that an independent public investigation of its operation must be conducted immediately to ensure that more Canadian lives are not put at risk. Diving headfirst into the controversy over calcium-channel blockers, the Alliance for Public Accountability also demanded that Ottawa pass whistle-blower protection legislation to prevent instances like the recent case where federal drug regulator Michele BrillEdwards was forced to quit her job to speak publicly about her concerns over Health Canada’s review of nifedipine. Brill-Edwards, who in an “act of conscience” resigned her position with the health-protection branch last January to protest deficient risk management in the regulatory review of calcium-channel blockers, told reporters on Oct 22 that the drug approval process is in “disarray”. Health Canada failed to apply the precautionary principle in approving nifedipine for use in treating angina and high blood pressure, BrillEdwards argued, adding that the department’s mandate specifically stipulates that it must not approve drugs until manufacturers have conclusively demonstrated the safety of their products. But manufacturers were able to have nifidepine labelled as a “second-line” rather than a “last resort” drug because deregulation and a “less rigorous approach to
drug evaluation” have created a situation in which drugmakers are allowed to continue manufacturing and marketing their products “until there is conclusive scientific evidence of harm.” Brill-Edwards also charged that Health Canada senior management are not adequately equipped and trained to resolve complex scientific issues and that the department is unable to apply “sufficient expertise” to analyse drug applications. Noting that the assessment committee which reviewed nifedipine included individuals who “had clear cut associations with the manufacturers,” BrillEdwards also argued that far more transparency is needed in the drug approval process. The APA also urged that the Access to Information Act be strengthened and that Ottawa create an “ethics commission with teeth and with powers of investigation (that) would send the message that fairness, honesty, openness and integrity are important values that must be protected.” Henry McCandless, who will retire this January after an 18-year stint as the Auditor General of Canada, also urged the current Auditor-General to use his authority to investigate departmental compliance with statutes to launch his own investigation into whether Health Canada’s drug review process is deficient in assessing drugs like nifedipine.
Contraceptive device not likely to win US approval
A
barrier contraceptive device, the Lea’s Shield, which has been safely sold over-the-counter in other countries, is not likely to appear in the US soon. On Oct 21, a federally funded research consortium presented its studies of the shield to a Food and Drug Administration advisory committee on behalf of the manufacturer, Yama. The committee voted against approval, saying the company needed to provide more data on more patients. The FDA also said it would require rigorous clinical trials to prove safety and efficacy—even though it did not consider the shield a breakthrough device. About 55 patients completed full US studies and, although there were no safety problems, the pregnancy rate was about 18% per year. The silicone device, which comes in one-size, was more effective with nonoxyl-9, a spermicide. Panelists said they could not approve a device to be used in thousands of women based on the results of 55 patients. The panel also hesitated to vote for approval because the FDA had warned that its decision could be used as a precedent to approve future barrier contraceptive methods. “It’s a precedent that will come back to haunt us,” said Jorge Blanco (Houston, USA).
Alicia Ault Barnett Wayne Kondro
Nazi war crimes and medicine 50 years on
O
n Oct 27, 1946, the trial of 20 Nazi doctors began in Nuremberg, Germany. Seven doctors were sentenced to death for their cruelty in the concentration camps. The trial judges set up a code of conduct to prevent medical experiments on people without their consent. 50 years later, the German section of the International Physicians for the Prevention of Nuclear War held a conference on medicine and conscience in Nuremberg. The main question discussed by more than 1500 participants was—has modern medicine learnt a lesson from the trials and has it followed the rules of the Nuremberg code? “That German doctors failed has never been acknowledged properly by German medical officials and the
1234
medical community”, said the medical historian Richard Toellner (Münster, Germany). Nazi crimes were attributed to 350 doctors, however, it is now known that almost half of German doctors were members of the Nazi party and, more significantly, many must have been aware of the murders of 80 000 mentally ill people and the sterilisation of thousands—or were even involved. A report of the Nuremberg trials, which was published as a book, never reached most German doctors. Even today silence surrounds doctors’ involvements in Nazi crimes, IPPNW officials said. Although doctors’ regional chambers as well as the national doctors’ organisation, Bundesärztekammer, were invited to participate in the meeting, none
responded. It is largely the work of researchers in the USA and Canada, many of them immigrants of German origin. Hartmut Hanauske-Abel, (New York, USA) and Jay Katz, (New Haven, USA) showed an example where Nazi data found its way into US space research. Modern medicine must learn new lessons from the Nuremberg trials. At the conference critical topics like preimplantation diagnostics, genome research, and rationalisation of medicine were discussed in the light of Nazi medicine, and led IPPNW to issue a Nuremberg declaration with ten aims to ensure medicine’s humanity. Annette Tuffs
Vol 348 • November 2, 1996
POLICY AND PEOPLE
Canadians inquire into drug licensing
A
newly created public-advocacy group charges that Canada’s drug approval process has become so lax that an independent public investigation of its operation must be conducted immediately to ensure that more Canadian lives are not put at risk. Diving headfirst into the controversy over calcium-channel blockers, the Alliance for Public Accountability also demanded that Ottawa pass whistle-blower protection legislation to prevent instances like the recent case where federal drug regulator Michele BrillEdwards was forced to quit her job to speak publicly about her concerns over Health Canada’s review of nifedipine. Brill-Edwards, who in an “act of conscience” resigned her position with the health-protection branch last January to protest deficient risk management in the regulatory review of calcium-channel blockers, told reporters on Oct 22 that the drug approval process is in “disarray”. Health Canada failed to apply the precautionary principle in approving nifedipine for use in treating angina and high blood pressure, BrillEdwards argued, adding that the department’s mandate specifically stipulates that it must not approve drugs until manufacturers have conclusively demonstrated the safety of their products. But manufacturers were able to have nifidepine labelled as a “second-line” rather than a “last resort” drug because deregulation and a “less rigorous approach to
drug evaluation” have created a situation in which drugmakers are allowed to continue manufacturing and marketing their products “until there is conclusive scientific evidence of harm.” Brill-Edwards also charged that Health Canada senior management are not adequately equipped and trained to resolve complex scientific issues and that the department is unable to apply “sufficient expertise” to analyse drug applications. Noting that the assessment committee which reviewed nifedipine included individuals who “had clear cut associations with the manufacturers,” BrillEdwards also argued that far more transparency is needed in the drug approval process. The APA also urged that the Access to Information Act be strengthened and that Ottawa create an “ethics commission with teeth and with powers of investigation (that) would send the message that fairness, honesty, openness and integrity are important values that must be protected.” Henry McCandless, who will retire this January after an 18-year stint as the Auditor General of Canada, also urged the current Auditor-General to use his authority to investigate departmental compliance with statutes to launch his own investigation into whether Health Canada’s drug review process is deficient in assessing drugs like nifedipine.
Contraceptive device not likely to win US approval
A
barrier contraceptive device, the Lea’s Shield, which has been safely sold over-the-counter in other countries, is not likely to appear in the US soon. On Oct 21, a federally funded research consortium presented its studies of the shield to a Food and Drug Administration advisory committee on behalf of the manufacturer, Yama. The committee voted against approval, saying the company needed to provide more data on more patients. The FDA also said it would require rigorous clinical trials to prove safety and efficacy—even though it did not consider the shield a breakthrough device. About 55 patients completed full US studies and, although there were no safety problems, the pregnancy rate was about 18% per year. The silicone device, which comes in one-size, was more effective with nonoxyl-9, a spermicide. Panelists said they could not approve a device to be used in thousands of women based on the results of 55 patients. The panel also hesitated to vote for approval because the FDA had warned that its decision could be used as a precedent to approve future barrier contraceptive methods. “It’s a precedent that will come back to haunt us,” said Jorge Blanco (Houston, USA).
Alicia Ault Barnett Wayne Kondro
Nazi war crimes and medicine 50 years on
O
n Oct 27, 1946, the trial of 20 Nazi doctors began in Nuremberg, Germany. Seven doctors were sentenced to death for their cruelty in the concentration camps. The trial judges set up a code of conduct to prevent medical experiments on people without their consent. 50 years later, the German section of the International Physicians for the Prevention of Nuclear War held a conference on medicine and conscience in Nuremberg. The main question discussed by more than 1500 participants was—has modern medicine learnt a lesson from the trials and has it followed the rules of the Nuremberg code? “That German doctors failed has never been acknowledged properly by German medical officials and the
1234
medical community”, said the medical historian Richard Toellner (Münster, Germany). Nazi crimes were attributed to 350 doctors, however, it is now known that almost half of German doctors were members of the Nazi party and, more significantly, many must have been aware of the murders of 80 000 mentally ill people and the sterilisation of thousands—or were even involved. A report of the Nuremberg trials, which was published as a book, never reached most German doctors. Even today silence surrounds doctors’ involvements in Nazi crimes, IPPNW officials said. Although doctors’ regional chambers as well as the national doctors’ organisation, Bundesärztekammer, were invited to participate in the meeting, none
responded. It is largely the work of researchers in the USA and Canada, many of them immigrants of German origin. Hartmut Hanauske-Abel, (New York, USA) and Jay Katz, (New Haven, USA) showed an example where Nazi data found its way into US space research. Modern medicine must learn new lessons from the Nuremberg trials. At the conference critical topics like preimplantation diagnostics, genome research, and rationalisation of medicine were discussed in the light of Nazi medicine, and led IPPNW to issue a Nuremberg declaration with ten aims to ensure medicine’s humanity. Annette Tuffs
Vol 348 • November 2, 1996