Procter and Gamble (P&G) continues to subvert the integrity of research regarding its osteoporosis drug Actonel by suppressing critical data even as the company touts its new openness, charges Government Accountability Project (GAP) client Dr. Aubrey Blumsohn. Blumsohn is a senior medical faculty member at England’s Sheffield University and lead researcher on a P&G grant to study the effectiveness of Actonel, the number two drug in sales in the highly lucrative osteoporosis market. Blumsohn charges that “P&G is again trying to avoid proper scrutiny of its questionable claims and is running roughshod over research integrity in the process.”
Blumsohn visited with U.S. Congressional officials last week to inform them of P&G’s data concealment regarding Actonel. In 2004, Blumsohn discovered that P&G concealed and omitted Actonel data in an apparent attempt to improve the drug’s image of effectiveness.
Faced with growing public scrutiny in both England and the U.S., P&G launched a public relations offensive last week in announcing a new “Bill of Rights” for researchers, stating that it would release the data from disputed clinical studies on Actonel to an “independent statistician” named by Sheffield University. Sheffield University, which receives substantial grant support from P&G, suspended Blumsohn six months ago for speaking to the media about his concerns regarding P&G data concealment and the way in which the University approached matters of integrity. Despite its new “Bill of Rights” promising unfettered access to data, P&G still refuses to provide Blumsohn with the raw data required to interpret his research into the drug.
Welcoming what he terms the company’s “battlefield conversion in issuing the ‘Bill of Rights,’” Blumsohn maintained that “Procter and Gamble is talking the talk but not walking the walk.” Blumsohn also observed that P&G continues to refuse to release data to him despite being the named author on medical abstracts, draft publications and statistical reports derived from his research.
P&G’s “Bill of Rights” was issued in the throes of widespread, trans-Atlantic attention to Blumsohn’s charges of data concealment by the company. P&G previously had asserted that it was “typical” for its internal statisticians to carry out analyses for supposedly independent external researchers and to withhold the full, underlying data set from the researchers. Blumsohn asserts that this makes a mockery of scientific integrity.
“Researchers have an ethical duty to review the data that supports their findings,” stated Blumsohn. “If a company can pick and choose what data the researcher can see, that compromises the ethics of the researcher and the integrity of the researcher’s findings.”
Researchers are supposed to be granted access to full data sets to reach informed conclusions. In 2001, an international coalition of the world’s leading medical journal editors called for all journal article authors to pledge that they had “full access” to drug study data. This was recommended in order to avoid data manipulation by corporate sponsors of product information. That editorial appears in the September 18, 2001 edition of the Annals of Internal Medicine.
GAP Food and Drug Safety Director Mark Cohen, Blumsohn’s lawyer, noted that “Dr. Blumsohn would be pleased to work with P&G and Sheffield to ensure that this ‘Bill of Rights’ is more than a public relations whitewash. If P&G is acting in good faith, the place to start is releasing the necessary data to him and to allow proper scrutiny. It will be necessary to compare any data provided with existing data, several previous intended and actual reports, and company statements about the process.”
Blumsohn added, “I hope that the university will join me in asking appropriate authorities for a critical review of this matter and the way it has been handled. This is the high road, and it would be better if it were taken.”