Clinical suppression

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This article was first published as "Clinically Suppressed"in PR Watch, Volume 10, No. 1, 1st Quarter 2003. It original article was authored by Andy Rowell and Bob Burton and is used here with permission. As with all SourceWatch articles, feel free to edit and revise.

In November 2002, Dr. Nancy Olivieri's six-year nightmare finally came to an end. During those years, she lost her job four times, was sued for $10 million, and her scientific reputation was dragged through the mud. What had she done wrong? She had told the truth.

Olivieri is a professor of Medicine at the University of Toronto and a physician at the Hospital for Sick Children, where she is an award-winning specialist in the treatment of hereditary blood disorders, especially thalassemia, a hemoglobin disorder.

Patients who receive treatment for thalassemia must endure regular blood transfusions and run the risk of chronic toxicity from too much iron in the blood, called "iron loading." This can affect major organs such as the heart and liver. An effective drug that prevents iron loading would therefore offer substantial benefits to the thousands who suffer from the disease.

In the early 1990s, Olivieri wanted to continue studying a promising drug called deferiphone, which appeared to reduce iron loading in transfusion-dependent patients. To fund the research, Olivieri and her co-workers obtained corporate sponsorship from Apotex, Canada's largest domestically-owned pharmaceutical company. This is in turn brought matching funding from the Canadian Medical Research Council. At the time, Apotex also happened to be in the middle of complex negotiations with the Olivieri's university about a $30 million financial donation, the largest in the university's history.

Olivieri signed two contracts continuing an already existing trial and starting a completely new one. However, Apotex had the right to withdraw funding at any time, and the contract for continuation of the existing trial also gave Apotex the right to control communication of the drug trial data for a year after the trial finished.

By 1995 Olivieri and her co-collaborator, Dr. Gideon Koren had identified an unexpected risk: in six of 21 patients studied, tissue iron burdens were higher than expected. Crucially this meant that the drug lost effectiveness over time. By early 1996, the number of patients with high iron burdens had doubled to 12.

This was not the outcome Olivieri had wanted. To the contrary, she had spent years hoping the drug would work. Nevertheless, she felt an obligation to inform patients in the clinical trials that there was a problem. In accordance with the Hospital's Ethics Board, she told Apotex of this decision. Apotex disagreed. The company did "agree that some patients [were] responding inadequately," but stated that the trials should continue and wanted "no further action."

When Olivieri went ahead and informed her patients in May 1996, the company reacted swiftly and severely. An investigation by the Canadian Association of University Teachers (CAUT) found that, in response, Apotex, showed "disregard for the interests and concerns of patients when without notice, it terminated both trials and stopped supplying the drug." Apotex also warned that it would "vigorously pursue all legal remedies," if Olivieri spoke to her patients or published anything.

According to the CAUT: "Apotex acted against the public interest in issuing legal warnings to Dr. Olivieri to deter her from communicating about risks" of the drug trials. The company would subsequently deny ever having written any threat.

Showing just how intertwined corporate and public research had become, the person who terminated the trials was Apotex Vice President Dr. Michael Spino, who had been a full-time member of the University of Toronto Faculty of Pharmacy from 1975-1992, at which time he left to join Apotex. However, Spino still held a "status" professorship at the University.

By February 1997, Olivieri was worried that she had discovered a further unexpected, but potentially far more serious problem with the drug. She became concerned that it might cause liver fibrosis, findings that were backed up by other scientists working in England. Working with colleagues she drafted a report for regulators warning of this "severe adverse reaction."

Meanwhile, the drug company began efforts to convince the regulatory authorities, patients, the hospital and the wider scientific community that the drug was safe, while privately proposing to change the testing procedure to remove vital tests. They wrote to Olivieri warning that her results were not "not scientifically valid" and threatened their "business."

Throughout this three-year ordeal, Olivieri received no support from the Hospital for Sick Children or the University of Toronto. At the beginning of 1999, she was dismissed from her post as director of its hemoglobinopathy program. She and some of her close colleagues were later gagged by the Hospital for Sick Children. After mediation, she was reinstated and allowed to continue research in late January 1999. The hospital also belatedly promised to support her financially if Apotex sued her.

By 2000, the increasingly bitter feud had reached the courts. Olivieri sued Apotex for libel after the company accused her of making "false" statements. Apotex filed a counterclaim against Olivieri, asking for $10 million damages. Various different committees and inquiries were also held into the whole saga.

In January 2002, the CAUT published a supplement to its investigation, concluding that Dr. Olivieri had been exonerated by their inquiry and three others, including an inquiry conducted by the Dean of the Faculty of Medicine of the University of Toronto. "Unless the lessons are learned," wrote the CAUT, "everyone will lose. It is important to recognize that the circumstances that gave rise to this case are not isolated--they illustrate a system-wide problem."

In November 2002, a settlement was reached that "resolved all outstanding litigation and arbitrations pending between all the parties." But Olivieri's case may only be the tip of the iceberg.

The British Medical Journal (BMJ) has warned about the "proliferation of stories of companies suppressing publication." A month before the Olivieri settlement, a paper in the New England Journal of Medicine concluded that universities "routinely" engage in lucrative industry-sponsored research that restricts academic freedom.

Dr. Kevin Schulman from Duke University Medical Center found that "academic institutions rarely ensure that their investigators have full participation in design of trials, unimpeded access to trail data, and the right to publish their findings." Schulman's team surveyed more than 100 medical centers in the US and found that only one percent involved in multi-center studies had independent access to all trial data.

In March 2001, the BMJ revelations that the Wyeth pharmaceutical company had "shelved" a study of its contraceptive pills that indicated "clear increases in the risk of developing deep venous thrombosis." Although Wyeth provided the data to regulatory authorities, it did not submit it for publication as "the study did not offer any new scientific information."

Six months later the BMJ editorialized about problems that have arisen due to the "entanglement" of academia with industry, noting that "control lies in the commercial rather than in the academic or public sector." Methods used by industry included designing "studies likely to favor their products" and analysing data "providing the spin--that favors them."

This entanglement worries Olivieri deeply. "Commercialization of university research," she says "benefits companies at the expense of the public good."