6 June (AHRP) – A dust storm is being kicked up following the announcement at the annual meeting of the American Society of Clinical Oncology of the early suspension of Johnson & Johnson’s drug trial testing its prostate cancer drug, aribraterone (Zytiga). The decision to suspend the trial is viewed as highly questionable, raising disturbing questions about the role that marketing played–especially in light of the fact that Zytiga’s patent is due to expire in 2017.
The trial was suspended by J & J’s Data Safety Monitoring Board (DSMB), a committee that operates in secret. The DSMB determined that the data showed that the drug reduced the spread of prostate cancer by 57%, and that the results hinted, but didn’t prove, that Zytiga was extending the men’s lives by a startling 33%.
But the decision to suspend the trial is viewed as highly questionable, raising disturbing questions about the role that marketing played–especially in light of the fact that Zytiga’s patent is due to expire in 2017.
Could marketing considerations have been the determining factor leading to the suspension of the trial, thereby promoting its (unproven) superiority?
Wall Street analysts wasted no time in trumpeting the news to their clients as a positive for J & J and a negative for its rival Dendreon.
The Zytiga trial enrolled 1,088 men around the world who had prostate cancer that had spread, but who hadn’t yet turned to chemotherapy. The patients, at 151 clinical sites in 12 countries, had no visible symptoms or only mild symptoms of their disease. They were randomly assigned to get Zytiga or a placebo.
Forbes science reporter, Matthew Herper, notes:
“lately DSMBs have been deciding to stop trials early an awful lot, causing some statisticians to worry that they are too eager to deliver early results. Stopped-early studies proved the benefits of Viread for preventing HIV infection, Afinitor in breast cancer, Viread for preventing HIV infection, Crestor for preventing heart attacks and strokes, Revlimid for use in multiple myeloma after a stem cell transplant, Sutent in treating the rare form of pancreatic cancer that afflicted Steve Jobs, and studies of Lotrel and Norvasc, both blood pressure drugs, just to name a few.”
He further informs us that DSMBs “are often recruited by companies themselves, [and] are making decisions “driven by marketing considerations” and the desire to get drugs to market faster and not their obligation to society.” (Story at Forbes.com).
DSMBs were established as independent monitors of clinical trial data in real time–data to which they alone are (presumably) privy. DSMBs were introduced as a safeguard to protect the safety of human subjects while maintaining the integrity of the blinded study. DSMBs are empowered to suspend a study for ethical reasons–when the evidence demonstrates unambiguously that one treatment is overwhelmingly superior for survival to the other.
As with pretty much every aspect of clinical trials, the integrity of the entire process is muddied by those with high financial stakes in the endeavor. Those stake holders control the protocol design and time frame, the selection of the research centers and the investigating scientists, the number and selection of patients, the data and data monitoring boards. Absolutely nothing is left to impartial evaluation or oversight. Indeed, “Michael Meyers, the J&J executive in charge of Zytiga, said that the DSMB makes only recommendations, and that the sponsor – the company – makes final decisions.”
Likewise, GlaxoSmithKline and Merck were intimately involved in the deliberations of their DSMBs involving the diabetes drug Avandia (GSK) and the cholesterol drug Vytorin (Merck).
To paraphrase a Mae West quip in response to an admirer who exclaimed, “Goodness, what beautiful diamonds…” to which Mae West famously responded: “Goodness had nothing to do with it.”
Ethics had nothing to do with these suspensions.