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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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Ordering the food for thought

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

Author: Vijay Prabhakar
Position: Pharmaceutical Physician
Institution: PPC CRO
E-mail: rvprabu@sify.com
Submitted Date: July 14, 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.

The recent series of articles in journals mainly published from the UK have been highly critical of the pharmaceutical industry [1-3]. The article in PLOS Medicine goes a step further and suggests the set-up of a new body to act as a bridge between industry and academia: the Collegiate Research Council (CRC).

While the message that all results of clinical trials will have to be disclosed is undisputedly welcome the generalized biased views against the industry needs to be viewed with a balanced thought. Although there have been few instances of the industry failing to adhere to expected high standards, nevertheless the industry has acted ethically in most instances and should be commended for delivery of important drugs. After all how many drugs have been discovered in pure academic bodies? It is unlikely that having more organizations like the CRC will be of additional benefit, rather they will become bureaucratic bodies with lobbies operating within them. In addition, who is going to fund these bodies? Pharmaceutical companies will have other methods to fund investigators as non-trial related expenses. How is the CRC going to control this? An organization like the CRC will become redundant in the long run consuming significant amounts of time and human resources. Controlling prices of drugs is simply unreasonable and it is well known that pharmaceutical companies balance price based on profit and affordability and this too is within a limited time-frame until the generics take over. How many countries have control over hospital charges and physician's consultations? It is unreasonable to expect the industry alone to bear the brunt of escalating healthcare costs.

In fact, more efforts need to be directed at how the receiver obtains information rather than what is provided to them. It is well known that most physicians do not read trial reports beyond that of the abstract or few tables thus making biased inferences by missing data hidden in the full text. This could be due to lack of time or non-availability of the full text. Providing open access is a good start in this direction. In addition, physicians should have free access to data submitted to regulatory authorities. Medical students should be taught how to analyze trial results and encouraged to learn medical statistics as part of their coursework. Physicians should be educated to be not carried away by a journal's impact factor and analyze merits of an article based on their own independent judgment and in the context of their practice. On the other hand, placing more regulations on the industry will only serve to increase the web of bureaucracy in a world that has more than its required share of such bodies and impedes global harmonization.

In the past guidance documents were merely dependent on published studies. It would be more reasonable if the members of the guidance committee also look at unpublished resources from pharmaceutical company websites and actively seek results of published protocols even if they are not peer-reviewed. Many journals reject articles for various reasons and rejection of an article does not always imply a poor study. In my experience as a physician in the industry I find a sizable number of articles rejected and data from those patients goes unrecognized. Conflicts of interest of peer reviewers and journal editors cannot be ignored.

In conclusion, one sided criticism of the pharmaceutical industry is unfair and physicians need to know what food should be digested among the plethora of what is served to him, rather than expecting someone else to judge this important decision.

Competing interests declared: The author has been employed in the pharmaceutical industry in the past and is currently employed with a CRO. The views expressed here are that of the author and not that of his employers.