How whistleblowing cost one doctor

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How whistleblowing cost one doctor £550000

Koos Stiekema, who delayed a clinical trial by revealing his worries about it to three ethics committees, tells Tony Sheldon how he thinks whistleblowers should be protected

Dutch former medical researcher Dr Koos Stiekema is convinced of the "potentially disastrous" effects for doctors workingin industry after a court's decision to award huge damages againsthim forwhistleblowing.

Dr Stiekema left the pharmaceutical company Organon after a dispute over the design of the PENTUA (pentasaccharide in unstableangina) study into the efficacy of a new anticoagulant, pentasaccharide.He then laid his serious concerns for the lives of the trial patientsbefore the three independent medical ethics committees that wereoverseeing thestudy.

His actions led to a claim against him for a three month delay to the study, estimated at more than 900000 (£550000; $827000). Despite facing financial ruin, he maintains: "Doctors employedby the pharmaceutical industry are obliged to do their utmostto reduce as much as possible any risk for patients participatingin clinicaltrials."

If a doctor is convinced that serious concerns cannot be conveyed internally, then Dr Stiekema sees "no other way" than informingindependent medical ethics committees. "Whistleblowers shouldfirst of all be the company's doctors. They have to have the facesand families of patients in mind and should really ask themselves:`What if the subject was my wife or child?'"

Last December a court in Amsterdam accepted Organon's claim that Dr Stiekema had not fulfilled his obligations to confidentialitylaid out in his employment contract and had, by informing themedical ethics committees of his concerns, caused "considerablefinancial disadvantage."

The court ruled that his professional responsibilities did not give him a free hand to act, and it did not accept that therewas no other option at that moment. Indeed it accepted that Organonhad sufficient facts to be satisfied that it had fulfilled itsobligations as a pharmaceutical company with regard to the professionaland scientific differences concerning the PENTUA study. An appealis now set to begin next week that will raise the issue of whethersuch whistleblowing can be justified on medical, moral, and legalgrounds.

Professor Mike Greaves, chairman of the haemostasis and thrombosis task force of the British Society of Haematology, saidin an interview with the Dutch radio station VPRO after the court'sdecision that Dr Stiekema's serious objections were well argued.He said that there were enormous consequences if doctors wereunable to make public their ethical objections without sufferinga financial burden.

Dr Stiekema, 53, who now works in Mozambique as an internist at the Maputo Central Hospital, joined Organon in 1982, risingto become a medical research manager. He was responsible for theinternational study into the optimal dose of pentasaccharide forpreventing heart attacks or death in patients with severe unstableangina.

After serious disagreements with the company about the design of the study (see box), Dr Stiekema felt he could not take responsibilityfor the new design and asked to be given otherwork.

Organon could not find him alternative work, so he was put on paid leave while an arbitration committee was set up to considerhis concerns.

However, Dr Stiekema could not agree with Organon's plans for arbitration. This involved the company appointing two arbitersand he only one. A majority would then decide the issue. He wasalso concerned that both Organon's arbiters had links with thecompany and, he felt, "could not be guaranteed to give an entirelyindependentview."

Relations worsened and Organon began legal proceedings to annul his employment contract. In May 1999 a court agreed to theannulment but awarded Dr Stiekema damages of approximately 350000.Within days of the judges' decision to annul his employment contract,he wrote to three independent medical ethics committees in France,Germany, and the United Kingdom that were overseeing thestudy.

Dr Stiekema argues: "All the facts, such as animal and human research data, should have been and probably were already inthe medical ethics committees' possession. But they often do nothave sufficient expertise to interpret all data supplied or tospot the risks, especially if the data concern entirely new chemicalentities, as was the case withpentasaccharide."

The PENTUA studies went ahead and the results were presented at a congress in the United States last year. There had beenno surplus deaths, and researchers concluded that the dose hadbeencorrect.

Dr Stiekema is concerned that doctors are now under increasing pressure to accelerate clinical research, as pharmaceuticalcompanies have "thousands of exciting new chemical entities ontheir shelves."

He hopes that the debate in the Netherlands arising from his case could produce some benefits. He would like to see medicalethics committees being obliged to keep confidential informationreceived from whistleblowers. Pharmaceutical companies in turnshould be obliged to inform these external committees about allissues relating to the safety of trialpatients.

Professor Andre Broekmans, Organon's director of pharmaceutical policy, said: "Stiekema had the means to raise this issuewithin the company but he did not exploit them to the fullextent.

"Independent scientific steering committees, international experts in the field of cardiology and thrombosis, and medicalethics committees in the countries concerned accepted that Organon'sposition was right and ethical. In our view the scientific discussionis closed. He had an opinion but he could not get any backingfor it. The study protocol was adapted to ensure patients wereintensely monitored."

What the argument was about

The dispute between Dr Stiekema and Organon was over the design of the PENTUA (pentasaccharide in unstable angina) study intothe efficacy of a new anticoagulant, pentasaccharide, and theoptimaldose.

Dr Stiekema proposed a "stepwise" design for the study, with two phases. In the first phase, doses of 12 mg, 8 mg, and 4 mgwould be tried. In the second phase a dose lower than 4 mg wouldbe given, provided that, at interim analysis, the 4 mg dose inthe first phase had not proved ineffective. But some people inthe company wanted to include a dose of 2.5 mg from theoutset.

Data available at the time led Dr Stiekema to conclude that doses of less than 4 mg were unlikely to be effective. He acceptsthat his stepwise design would have been more cumbersome and timeconsuming than a one phasedesign.

"The core of my objection to embarking from the outset on a dose as low as 2.5 mg was that in my opinion a sponsor is obligedto do all in its power to avoid risks, certainly if these arein the magnitude of death or heartattack.

"I never said that doses lower than 4 mg could with certainty not be efficient. I even included in my original design a doseas low as 2 mg, but this was only to be embarked on if the efficacyof the drug at a higher level had indeed beenshown."

However, in November 1998 Organon concluded from its expert advice that embarking on a study using a dose of 2.5 mg was responsible.

Whistleblower Koos Stiekema

© BMJ 2002