Thoughts on Drug Companies
Sodium valproate 1961
1991 semi-sodium valproate (depakote)
from there, branding of mood stabilizers began (spin)
biplar d/o branding given 1980
since mid-1990s, publicications are
now, fortunes of companies depend on key compounds
assembly line in clinical trials
Stone and Jones, 2006
- looking at SSRIs and the minimal benefit above placebo
Index on Censorship
www.msmonographs.org/preprintable.asp?id=39302
one idea: perhaps the NY times should publish RCTs, as they'd insist on seeing the data much more than ie NEJM
BMJ 2006, Healy
Strategies
"The evidence cannot lie"
Current Medical Directions, Inc - publisher of articles, monographs, etc
- ghostwriters write a substantial amount of these
disease mongering
if can get indication for a medication, can 'sell' disease to people and then feed up the treatment
Caveat emptor
The commoditization of health has made the pharmaceutical industry one of the most profitable in the world, with global 2006 sales topping 643 billion $US.1 This success is due to a number of factors. Drugs have, in many ways, revolutionized medicine, allowing doctors to thwart life-threatening infections and significantly prolong life in the face of chronic diseases. Clearly, it makes sense to reward companies who help save lifes and reduce suffering. At the same time, however, it is important to consider the enormity of such expenditures, examine the forces that cause them to come into play, and evaluate their motivation.
Canada's expenditure on prescription drugs was over $20 billion in 2006, with per capita spending almost doubling between 1998 and 2004. This increase in spending was due to both an increase in volume of precriptions, and the selection of increasingly costly options from within drug categories.2
US pharmaceutical companies spend almost twice as much on promotion and marketing drugs (US 57.5b) as on research and development (31.5b). As a result, most of the new drugs coming out have little or no new therapeutic value, but instead are very similar to what is already available. This works out to nearly 25cents of every dollar spend on prescription drugs going to promotion - sales reps visits, drug samples, and drug ads. (Gagnon and Lexchin, 2008)
Cholesterol
The best-selling drug in the world is Lipitor (atorvastatin). In the last major revision of US guidelines, citing a number of randomized control trials, the number of people for whom statins were recommended for primary prevention increased from 13 million to 36 million. However, not one of the referenced studies provided evidence to support such recommendations (Abramson and Wright, Lancet 2007). For adults with occlusive coronary disease, statins provide demonstrated reduction in cardiovascular mortality. However, patients with no evidence of such disease account for three-quarters of those taking statins. Analysis suggests that statins should not be prescribed for primary prevention in women and men over 69 years of age. For high-risk men between 30-69 years, 50 patients need to be treated for 5 years to prevent one event. Presented with this information, especially after learning of the benefits of lifestlye modification, many men do not choose to take a statin (ref). As such, best evidence-based guidelines would lead to much smaller numbers of statins being prescribed. Even among men on lipid-lowering or anti-hypertensive medications, lifestyle changes have the potential to prevent a majority of CHD events (Chiuve et al, 2006)
Pharmaceutical Bias
The primary goal of pharmaceutical advertisements is to convince physicians to prescribe the product. In order to do this, claims, which may or may not be true, are made about the benefits of products. In our 'world' of evidence-based medicine, it is critical for readers to use cautious interpretation when evaluating these claims. Thankfully, Dalhousie's medical program builds these abilities in our CECT course, but...
One study examining the source of information used in claims found that over one-quarter of ads contained no references. Unpublished references were used in nineteen percent of claims, with 80% of requests for this information going unanswered by the manufacturer (Cooper and Schriger, 2005). This behaviour disregarded the policy of the Canadian Pharmaceutical Advertising Advisory Board (http://www.paab.ca/index_en.html)
and the majority of published references were funded by, or had author affiliation with, the product's maunfacturer (Cooper and Schriger, 2005). However, published references are not enough. A staff member at an unnamed journal that checks submitted ads for scientific accuracy before accepting them says he asks for changes to be made in one third of ads (Giles, 2005) In fact, in one study, nearly half of referenced statements were not supported by the reference. The most common reasons had to do with generalization of outcomes, with specific claims being made when the cited study was about intermediate outcomes, other patient populations, or in some cases even animals (Villaneuva et al, 2003). In another analysis of the accuracy of pharmaceutical advertisements, experts were asked to evaluate ads in their field. In the experts' opinions, 44% would lead to improper prescribing if physicians used this information alone, while 92% of ads were not in compliance of criteria of the FDA (Wilkes et al, 1992). This report led to the withdrawal of pharmaceutical ads from the publishing journal (Fletcher RH, 2003).
Pharmaceutical ads often refer to published work funded by the manufacturer of the drug used. Even within randomized trials, a significant association exists between source of funding and favourable conclusions of the trial. This appears likely due to biased interpretation of trial results (Als-Nielsen et al, JAMA, 2003). Superiority trials were more likely to favour newer, more expensive treatments over current standard of care when funded by for-profit organizations (Ridker and Torres, JAMA 2006).
Study after study have shown that claims used in advertising can be misleading, distort the reporting of scientific data, or fail to provide enough information to accurately interpret data. (Cooper and Schriger, 2005)
Talk a bit about how advertising affects medical trainees.
References
Abramson J and Wright TM (2007) Are Lipid-lowering guidelines evidence-based? Lancet 369(9557):168-9.
Gagnon MA, Lexchin J (2008). The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States PLoS Medicine Vol. 5, No. 1, e1 doi:10.1371
Giles J (2005) Journals lack explicit policies for separating eds from ads. Nature 434, 549
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