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Regulation of Clinical Research Sponsored by Pharmaceutical Companies: A Proposal

  • Julio Sotelo
  • Published: July 11, 2006
  • DOI: 10.1371/journal.pmed.0030306

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A more comprehensive alternative

Posted by plosmedicine on 30 Mar 2009 at 23:57 GMT

Author: Peter Mansfield
Position: Director
Institution: Healthy Skepticism Inc
E-mail: peter@healthyskepticism.org
Submitted Date: July 13, 2006
Published Date: July 18, 2006
This comment was originally posted as a “Reader Response” on the publication date indicated above. All Reader Responses are now available as comments.

Julio Sotelo's proposal for pharmaceutical research to be organised by a Collegiate Research Council (CRC) funded by drug companies [1] is one of several alternatives that deserve debate.

The Sotelo proposal has advantages but if the CRC is a single international monopoly how could the risk of corruption and inefficiency be managed? Competing CRCs would be under pressure to compromise to win more contracts as happens already with Contract Research Organisations.

Fiona Godlee has proposed that pharmaceutical manufacturers be banned from researching their products.[2] She suggests that "to get their products licensed [drug companies] would contribute to a central pot for independent, publicly funded clinical trials." She did not specify what percentage of the "central pot" would be funded by taxpayers vs pharmaceutical companies. If the funding was mostly from pharmaceutical companies then her proposal is similar to Sotelo's. If not, how will governments to be persuaded to allocate adequate funds?

My organisation, Healthy Skepticism Inc, advocates a more comprehensive alternative that will also reduce the harm currently caused by misleading promotion, biased industry funding of education, and high drug prices. Our alternative is politically achievable because implementation can be government revenue neutral whilst securing long term competitive return on investment for the pharmaceutical industry.

Pharmaceutical companies currently have four main functions: manufacturing, research, promotion, and education. Performance of those functions is currently distorted by incentive systems that reward only activities that increase sales of more expensive drugs regardless of the impact on health care. We recommend that the four functions be paid for separately by government agencies via iterative competitive public tender. This would allow the relevant divisions and subcontractors of pharmaceutical companies to compete with universities and other non-profit organisations (NGOs) for funding to provide each function separately. Incentives can then to be aligned to reward quality performance at each function separately. If a company performed poorly, eg research fraud or misleading promotion, then it would not get funding for that function in the next tender round. Drug prices would no longer include a premium for research, promotion and education. Consequently, drug companies would no longer fund those functions from drug sales. Lower prices would make drugs more cost-effective for larger numbers of people.

Our recommendations can be implemented quickly or slowly by gradually reducing prices and transferring the savings to organisations that fund research (eg UK Medical Research Council) education (eg medical schools and specialist colleges) and promotion (eg Best Practice Advocacy Centre, New Zealand). We also recommend improving regulation of pharmaceutical companies and improved education, incentive systems and regulation for health professionals.[3,4,5,6]

1. Sotelo J (2006) Regulation of Clinical Research Sponsored by Pharmaceutical Companies: A Proposal. PLoS Med 3(7): e306

2. Godlee F. Can we tame the monster? BMJ 2006 July 8;333(7558)

3. Sweet M. Doctors and drug companies are locked in 'vicious circle'. BMJ 2004 Oct 30;329(7473):998

4. Mansfield PR. Healthy Skepticism about drug promotion: Memorandum for the UK House of Commons Health Committee Inquiry: The Influence of the Pharmaceutical Industry. Healthy Skepticism International News 2004 Oct; 22(10-12)1 www.healthyskepticism.org...

5. Mansfield P, Rogers W, Jureidini J. Submission from Healthy Skepticism re RACP Ethical Guidelines. Healthy Skepticism International News 2005 Sep; 23(9)1 www.healthyskepticism.org...

6. Mansfield PR. Banning all drug promotion is the best option pending major reforms. J Bioethical Inquiry 2005;2(2):16-22

Competing interests declared: I have received funding from organisations that would benefit from implementation of Heathy Skepticism's recommendations including the many universities, the Royal Australasian College of Physicians and the National Health and Medical Research Council (Australia).