Should Drug Companies Carry Out Their Own Clinical Trials?

Editor's Choice
Main Category: Clinical Trials / Drug Trials
Also Included In: Pharma Industry / Biotech Industry
Article Date: 30 Nov 2009 - 0:00 PDT

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Two experts question on bmj.com today whether the conflict of interest is unethical when drug companies perform clinical trials on their own medicines.

Their opinions come as new guidance on the obligatory standards for communicating company sponsored medical research.

Vincent Lawton is a healthcare consultant and non-executive director at the Medicines and Healthcare products Regulatory Agency in London. He argues that after having invested billions of pounds in medicine development, it is unrealistic to expect the drug industry to "surrender its intellectual property." He comments that withdrawing research from pharmaceutical companies will lead to delays, ineffectiveness and a deficiency in innovation.

Ben Goldacre, a doctor and writer from London disagrees and argues that "it is hard to see any justification" for allowing the present situation to carry on.

Goldacre remarks that there is growing evidence pointing to a conflict of interest for the drug industry which "results in bad evidence, which distorts medical decision-making, and harms patients."

Goldacre argues that one of the problems is that the industry can choose which data to publish and which to leave unavailable. He refers to the difficulties in getting clear information about the number of suicide attempts in industry trials of SSRI antidepressants or the number of heart attacks in individuals taking the anti-inflammatory drug rofecoxib (Vioxx).

In conclusion, Goldacre comments that the current situation "is dangerous and absurd." He says that "doctors who are making treatment decisions need access to good quality trial data, presented transparently, and all of it, not just the positive findings that drug companies choose to share."

Vincent Lawton, on the other hand, believes that it is suitable for the drug industry to make a profit and still carry out accurate clinical trials that stand up to regulatory inspection.

He points out that, in January 2005, the industry made a commitment to increase the transparency of clinical trials by registering its trials in central, publicly accessible databases. Most major companies also publish trial results, whether positive or negative, on their own websites.

Lawton concludes by indicating that it is doubtful that publicly sponsored academics would have the infrastructure to conduct all clinical trials on all new medicines, leading to regulatory approval.

Also published on bmj.com today is an associated article setting out new guidance for communicating company sponsored medical research.

The good publication practice (GPP2) guidelines are written by the International Society for Medical Publication Professionals. They have been updated in response to changes in the environment in which authors, presenters, and other contributors work together to communicate medical research.

They incorporate guidance on defining the roles of authors, sponsors, and other contributors, recommendations about reimbursement, and confirmation of the role of professional medical writers, and apply to peer reviewed journal articles and presentations at scientific conferences.

Lead author, Chris Graf explains the guidelines "make recommendations that will help individuals and organizations maintain ethical practices and comply with current requirements when they contribute to the communication of medical research sponsored by companies."

"Is the conflict of interest unacceptable when drug companies conduct trials on their own drugs? No"
Vincent Lawton
BMJ 2009; 339:b495

"Is the conflict of interest unacceptable when drug companies conduct trials on their own drugs? Yes"
Ben Goldacre
BMJ 2009; 339:b4949

"Good publication practice for communicating company sponsored research: the GPP2 guidelines"
Chris Graf, Wendy P Battisti, Dan Bridges, Victoria Bruce-Winkler, Joanne M Conaty, John M Ellison, Elizabeth A Field, James A Gurr, Mary-Ellen Marx, Mina Patel, Carol Sanes-Miller, Yvonne E Yarker, for the International Society for Medical Publication Professionals
BMJ 2009; 339:b4330
doi: 10.1136/bmj.b4330
bmj.com

Written by Stephanie Brunner (B.A.)


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