Friday, December 23, 2005

More Summary, and Much Documentation of the Blumsohn Case: "Rent-a-Researcher?"

A new article about the case of Dr Aubrey Blumsohn has just appeared in Slate, written by Jennifer Washburn. The title says it all.

It does a good job summarizing events in the case so far. What is most remarkable is that it links to a series of documents and recorded conversations that back up what has been reported previously. (See our last post here, with links to previous posts.)

The key points of the case are as follows, (with relevant links to documents and recordings):

  • Dr Aubrey Blumsohn, a senior lecturer at Sheffield University, and Professor Richard Eastell performed a research project on the effects of the drug risedronate (Actonel, made by Procter & Gamble Pharmaceuticals [P&G]) under a contract between P&G and the University.
  • Although the research contract designated Blumsohn and Eastell as "Investigators" under whose direction the project would be carried out, Blumsohn was not given access to the original data collected by the project.
  • Despite numerous requests, (like this one), P&G refused access to this data repeatedly.
  • Blumsohn was concerned that he and Eastell could be accused of scientific fraud if they continued to make presentations and write articles and abstracts without access to the data which they were supposedly writing about.
  • Blumsohn became suspicious that some of the analyses done by P&G could be misleading, especially related to a graph shown to him that omitted 40% of patient data.
  • Blumsohn objected to P&G arranging for papers and abstracts to be written by a professional writer, but with Blumsohn listed as first author. Blumsohn was concerned that such ghost-written documents were mainly meant to convey "key messages" in support of P&G's commercial interests.
  • Eastell warned Blumsohn not to aggravate P&G, because the company was providing a grant to the University which "is a good source of income."
  • After repeated failed attempt to get the data, Blumsohn complained to numerous officials at Sheffield University, including Eastell, medical school Dean Tony Weetman, University Vice-Chancellor Robert Boucher, and the Head of the University's Department of Human Resources, Ms R Valerio.
  • Still unable to get the data, he spoke with news reporters about his case. At this point, Sheffield suspended him, but then offered him a severance agreement if he signed a contract binding him not to make any detrimental or derogatory statements about the University and its leaders.
A good summary of the case written by Blumsohn (in the letter to Valerio):
I performed a large-scale research project involving samples collected as part of FDA trials used to register the drug Risedronate (RJ102356). Measurements were performed in my laboratory, and Professor Eastell was coinvestigator. The aim of the study was to address an important and controversial question relating to this class of drugs. The company failed to allow investigators access to randomisation and event codes from the study. They continued to refuse access to this information to authors even after ghost-authoring work in the names of myself and Professor Eastell, and after substantial and increasing information emerged to suggest that the company data analysis could not be trusted. This breached their contract with the university, although restrictive contracts are widely held to be unenforceable in any event. The procedure was in conflict with all of the norms of usual legitimate scientific conduct. It is not necessary for me to demonstrate exactly how data analysis was perverted. Nor is it necessary to elaborate the effect that this may have on patient care. The principle at stake is clear, and such a process involving a sponsor is not ever appropriate in clinical medicine, or in any other branch of science.
Washburn drew some important conclusions:
Why did Sheffield, a top-flight research university, try to silence and get rid of Blumsohn?
The answer appears to lie in the complex and increasingly compromised relationship that have grown up between some research universities and the pharmaceutical industry.
Universities with medical schools have become dependent on drug companies for an ever-larger share of their research budgets - roughly 80 percent of clinical research is now privately funded. And drug companies, in turn, have pressed for greater control over the research process, making it easier for them to obscure or delete negative results from published academic papers.
Universities have long accepted funding from pharmaceutical companies to conduct clinical trials. But in the past, their professors insisted on running those trials independent of the sponsor. As the Blumsohn case makes clear, this arm's-length relationship appears to be breaking down.
Whatever the solution, something needs to be done soon. Scholarly independence has taken too many hits.
Hear, hear.

1 comment:

InformaticsMD said...

These rejections by Clinical Research Organizations (CRO's) are beginning to make more sense.

Who would want a Medical Informaticist around if the goal is to obfuscate and conceal clinical data?