The United States is considered a leader world-wide in the development and research of new treatments for disease. One of the reasons this is so is due to our nation being much more lenient and tolerant of industry itself. A natural and positive outcome of capitalism is the ability to rapidly innovate and create new products and meet the demands of the marketplace without excessive restrictions and limitations present in some other nations. However, some argue that the strength of our pharmaceutical industry holds excessive influence over decision-makers top down and inhibits proper regulation of industry practices.
The influence of pharmaceutical companies begins in early medical training. Up to 90% of all undergrad clinical medical students receive exposure to industry educational material. Students acknowledge the bias of such material and believed their peers and doctors to be influenced by them, but not necessarily themselves. Several studies reviewed demonstrate a relationship between exposure to industry and favorable attitudes about pharmaceutical interactions and marketing strategies (Austin et. al 2001).
These established relationships continue after medical licensure. The Journal of the American Medical Association (JAMA) (2000) reports that industry sponsored Continuing Medical Education (CMEs), regular visits and funding increases physicians’ prescriptions of donor’s product. As of 2010, half of the CMEs available were industry funded. Pharmaceutical sponsors have substantial influence over the educational content, often pay prominent medical figures large sums to present information about the company’s latest products, and often provide the very slides used in the presentation. Is it at all surprising that sponsored CME courses lead to increases in prescription rates those who attend and hear the benefits of the sponsor’s product? JAMA has suggested that influence be curtailed through policy, however policymakers are also recipients of donations from drug companies.
Pfizer, for example, regularly donates to politicians and makes the choice by considering “candidates’ views on issues that impact Pfizer and its employees as well as the presence of Pfizer facilities or employees in the candidate’s district or state” (Pfizer, 2015).
Such donations facilitate favorable policymakers remaining in office and curtail stricter management of poor conduct, questioning the efficacy of self-regulation. Multiple reports of violations in misleading claims, off-label promotion and manipulation of data are regularly reported worldwide (Stamatakis, 2013).
One of the most well known examples of this is with Vioxx. Vioxx was a very popular (and effective) nonsteroidal anti-inflammatory drug (NSAID) that nearly doubled the chances of both heart attacks and stroke. Data revealed during court trials suggested Merck & Co. intentionally distorted the safety data from clinical trials and trained their sale reps on how to gracefully avoid physician questions about product safety.
Another matter of concern is direct to consumer advertising (DTCA). Since it began in the early 90’s, industry spending on DTCA for pharmaceuticals increased from $11 billion to $30 billion between 1996–2005, about “the same period of time when the total costs of prescription drugs were rising at a rate higher than 30% a year” (Stamatakis, 2013).
What are your thoughts on this? Do you feel the value of being able to bring products to market quicker is more valuable than tighter regulations to ensure proper conduct and appropriate promotion of medicine?
References:
1) Austad K., Avorn, J., Kesselheim A. (2011) Medical Students’ Exposure to and Attitudes about the Pharmaceutical Industry: A Systematic Review. PLoS Medicine, 8(5): e1001037
2) Wazana A. (2000) Physicians and the pharmaceutical industry – Is a gift ever just a gift? JAMA. 283:373–380. doi: 10.1001/jama.283.3.373
4) Pfizer Political Action Committee (2015) Pfizer Political Action Committee and Political Contributions Report. Retrieved from:http://www.pfizer.com/about/corporate_governance/political_action_committee_report
5) Zetterqvist, A. V., Merlo J. and Mulinari S. (2015) Complaints, Complainants, and Rulings Regarding Drug Promotion in the United Kingdom and Sweden 2004–2012: A Quantitative and Qualitative Study of Pharmaceutical Industry Self-Regulation. PLoS Medicine.12(2): e1001785.
6) Stamatakis E.,Weiler R. and Ioannidis J. (2013) Undue industry influences that distort healthcare research, strategy, expenditure and practice: a review. European Journal of Clinical Investigation. 43(5),469–475
