Thursday, February 23, 2006

Blumsohn Tours Washington to Raise Concerns About Pharmaceutical Research Integrity

We had posted a while back about the story of Dr Aubrey Blumsohn's dispute with Proctor and Gamble (P&G) and Sheffield University in the UK. In summary, Blumsohn and Professor Richard Eastell had done clinical research on the risedronate (Actonel), sponsored by P&G, the drug's manufacturer. P&G refused Blumsohn access to the original data from the study he was ostensibly running, and hired a ghost-writer to write abstracts in his name. Blumsohn protested to Eastell, who advised him not to make waves because P&G "is a good source of income" for the university. When protests to other university officials produced no results, Blumsohn told the story to the press, whereupon the university suspended him.

Blumsohn has been in Wahsington, DC, speaking with the staff of the US Senator Charles Grassley (R-Iowa) about the general problem of integrity of clinical research, prompting some renewed press coverage of this story. A brief Associated Press story summarized the issues involved. The Wall Street Journal (available here without a paid subscription) had another version, including this quote by Grassley

This isn't the first time, I bet it won't be the last, that we hear concerns about drug companies selectively witholding unfavorable clinical trial data. It's a recurring complaint and a detriment to rigorous scientific research.
Meanwhile, the British Broadcasting Service did a long radio feature on the case, (audio available here, but a transcript is not yet available).

It's time for this issue to be back in the spotlight.

The pharmaceutical industry produces many very useful products, which as a physician I frequently prescribe. Now, however, the industry seems to expect stratospheric returns for for some of its newer drugs. Numerous anecdotes, some mentioned previously on Health Care Renewal, however, have suggested that the industry has sometimes manipulated research data to make their latest products appear to be wonder drugs deserving of such high price tags. The industry is currently faced with continuing skepticism and declining trust, which may eventually make it hard to support even more modest pricing. The public, physicians, and the pharmaceutical industry itself would be better served by the industry's clear rededication to clinical research integrity.


insider said...

I believe Dr Blumsohn is being interviewed on BBC Radio 4 on Friday. Black Triangle has more details.

Anonymous said...

I have heard the interview and found it quite illuminating. As a scientist and postmenopausal woman, I was frankly flabergasted by teh lack of transparency in the drugs evaluation process.

I understand that the statistical treatment by P&G of the data obtained by Sheffield researchers gave rise to a totally new and ultimately erroneous theory of the beneficial effect of Actonel.

This has in turn meant that patients did not obtain promised benefits - namely the number of fractures did not support theory but was skillfully hidden from the researchers.

My question here is whether the patients have a case for damages against Proctor and Gamble for willful misrepresentation? I guess when their pockets get to be hit hard, pharma companies will have to start changing their ways.

Dr Lilly Evans, Dipl.Ing
Surrey, UK