Actonel

This article is part of the Pharma_Portal project of Spinwatch.

Actonel

Actonel is a prescription drug used to treat and prevent postmenopausal osteoporosis.

Controversy

Background

In 2002, Aubrey Blumsohn, former senior lecturer at Sheffield University, was asked to undertake the final phase of a study into the treatment of osteoporosis. The study was started in 2000 by his department head Professor Richard Eastell, who had been working with Proctor & Gamble (P & G) to prove the company's drug Actonel was as good as the leading drug on the market at the time, Fosamax. According to P & G, the intention was to induce a 'paradigm shift'in the way these drugs are understood to work and use it as part of a marketing strategy to get more doctors to use Actonel. Both drugs claim to reduce fracture risk by reducing 'bone turnover' - the process by which bone replenishes itself by releasing mineral content and becomes brittle. Blumsohn's larger study group would need to confirm Eastell's previous findings which showed that the benefit of decreased bone turnover 'plateaued' at around 35-40 per cent, thereby making the additional reduction seen with Fosamax irrelevant

According to section 4.3 of the signed agreement between the investigators and the drug company, there did not appear to be restrictive limitations on the rights and obligation of investigators. It was up to investigators to interpret and report on the data. The contract stated that the sponsor (P & G) should be given courtesy of sight of any proposed publication, but '...[the party] is not bound to incorporate such suggestions in any oral or written publications, except for the redaction of Information as necessary for the institution to fulfill its obligations of confidentiality under Article 3' (see documents under resources). Article 3 referred to the Company's Confidential Information and Proprietary Materials. One sentence stated: 'All information [disclosed to the university and investigators about the project] is considered to be highly confidential by the Company' (see documents under resources). Section 1.2 of the agreement obliged the university to impose its own professional rules of conduct. The University of Sheffield would have to turn to its own Research Integrity Guidlines (see documents under resources).

When the study commenced in 2002, blood and urine samples were tested from 3,000 people. Some were on Actonel, while others were on a placebo supplied by P & G. Samples were supplied with randomised codes so the investigator would not know which treatment patients were receiving. After hearing rumours at international conferences that Eastell's initial findings were being challenged, Blumsohn was forced to admit that all analyses had been done by P & G and not by himself. He asked Eastell for all the data and codes to be made available to him, and a request for the information was sent to P & G's UK statistician, Dr Ian Barton. In June 2002, Blumsohn was refused access to the codes on the grounds that they had been developed by P & G at great cost and that training him to use them would be a lengthy and time delaying exercise.

Outcomes

• In October 2005, the General Medical Council (GMC) was asked to investigate the matter (correspondence with Blumsohn).
• In December 2005, the Medicines and Healthcare products Regulatory Agency (MHRA) said it would investigate the claims: 'An allegation has been made and the MHRA is investigating.'
• A House of Commons debate was held in December 2005 on the regulation of the pharmaceutical industry.
• The Journal of Bone and Mineral Research confirmed that it would hold an inquiry into Blumsohn's concerns.

Resources

• Research contract between P & G and two named investigators: Aubrey Blumsohn and Richard Eastell Contract
• University of Sheffield's Research Integrity Guidelines Research Guidelines
• EDA Stats Analysis Plan for risedronate sodium (NE-58095) 24-Jul-2002 Actonel Statistical Plan