The (London) Observer - Doctor accuses drugs giant of 'unethical' secrecy

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SSRI-Research@

Sun, 4 Dec 2005 10:30:36 -0500

[sSRI-Research] The (London) Observer - Doctor accuses drugs

giant of 'unethical' secrecy

 

 

 

 

 

[ " Ghost writing " , research that has been concocted in the back rooms

of the pharmas, is a major problem. These papers are given, with a

sizable check, to the various medical " thought leaders " . They, in

turn, " sign off " on the material, cash the check, and the public is

lead to believe this " scientific " work is the work of the highly

respected person whose name appears in it's header. In many

instances, this person has never had access to the data upon which the

paper is based. ]

 

 

 

 

 

 

http://observer.guardian.co.uk/uk_news/story/0,6903,1657302,00.html

 

Doctor accuses drugs giant of 'unethical' secrecy

 

Jo Revill, health editor

Sunday December 4, 2005

The Observer

 

Britain's leading medicines watchdog is to investigate claims made by

a senior doctor of 'unethical behaviour' by a major pharmaceutical

company over a study of a disease that affects millions of women.

 

A series of emails and taped telephone conversations passed to The

Observer reveal that a highly respected academic in the field of

osteoporosis has questioned Procter and Gamble's decision to publish

drug research in his name even though he had not been given full

access to the data it was based on. The report was written by a 'ghost

writer' paid for by P & G before being given to the academic to agree.

 

The claims made by Dr Aubrey Blumsohn, senior lecturer and bone

metabolism specialist at Sheffield University, are to be looked at by

the Medicines and Healthcare Regulatory Authority.

 

The issue will also be debated by MPs this week when the Commons meets

to discuss whether the regulation of the pharmaceutical industry

should be strengthened.

 

Blumsohn has told The Observer that he became highly concerned about

the analysis of data collected as part of a study he was conducting on

drugs manufactured by Procter and Gamble. The research was into the

effect the osteoporosis drug Actonel had on women at risk of fractures.

 

Blumsohn claims that for nearly a year he was prevented from seeing

the full data, despite being named as the lead author on the study,

and having two reports published in his name. Two years after raising

his concerns about research conduct, he was suspended from his

university post after he threatened to speak to medical journalists

about the issue.

 

Procter and Gamble strongly denies his claims, and says that that it

is 'standard industry practice' not to hand over all data to academics.

 

It argues that it gave him as much access as possible to the

information that formed the basis for papers and conference posters

about the effects of the drug. But emails and taped telephone

conversations reveal that, for nine months between 2002 and 2003,

Blumsohn had to fight to be allowed to see the data. The company told

him that the ghost writer, Mary Royer, was familiar with the 'key

messages' they wanted to convey about the drug.

 

Actonel earns Procter and Gamble around $1 billion a year, and is very

widely prescribed for women with osteoporosis, a bone condition that

leaves them at risk of fractures. It is known to be a safe and

effective drug, and the issues raised by Blumsohn do not suggest

otherwise. It is competing against a rival osteoporosis drug, Fosamax,

made by Merck.

 

There are increasing concerns among medical ethicists about the

relationship between the major drugs companies and the academic

institutions that are paid millions of pounds each year to carry out

research on their behalf.

 

Pharmaceutical companies gain more credibility for their studies if

they bear the name of independent academics holding university posts

even if they haven't actually written the report.

 

In many cases, the work is carried out in a university laboratory and

then sent off to the company for further work. However, researchers

are supposed to have full and independent access to the data. This is

particularly the case if it ends up being published in a medical journal.

 

The MHRA will hold an initial inquiry into Blumsohn's allegations by

looking at the documentary evidence. They can go further and hold a

full inquiry if they decide that there is a case to answer. A

spokesman said last night: 'An allegation has been made and the MHRA

is investigating.'

 

A Commons debate will be held on Thursday on the regulation of the

pharmaceutical industry. The Liberal Democrat MP, Paul Burstow, who

sits on the health select committee, said: 'It is essential that

universities feel confident that they can defend their academics and

that they get the access to data which they need before they can give

it their stamp of approval.'