These famous words were spoken by Franklin D. Roosevelt (FDR) almost 70 years ago, but they still ring true today.
Following the tragic events of September 11, 2001, we have all been inundated with media coverage of terrorism on North American soil, troops at war in Afghanistan, Anthrax cases and the elevation of fear-based drug marketing to a new height. By now you've probably heard about the recent NBC news report during which Tom Brokaw held up a prescription bottle declared "In Cipro we trust". Once again an equally effective, but older drug (i.e. doxycycline) has been relegated to the back bench. More disconcerting is the fact that sales of ciprofloxacin have apparently tripled due to drug stockpiling. Don't get me started on the issue of generic ciprofloxacin supplies. So much for the quest for antibiotic stewardship. We haven't seen paranoia like this since late 1999. Remember the preparations for Y2K? It looks like we really haven't learned any lessons.
Although overlooked in the flurry of recent events, there is another important battle being fought this fall. Perhaps you managed to break away from these news stories long enough to read the article published in the September 10, 2001 issue of CBC News Online. As identified by the author, some of the world’s leading medical journals have signed a pact aimed at ferreting out biased research and are adopting tougher guidelines to stop pharmaceutical companies from interfering in drug research. No small task. Several journals (including the Canadian Medical Association Journal, the New England Journal of Medicine, the Journal of the American Medical Association, The Lancet, the British Medical Journal, Annals of Internal Medicine) now claim that they will refuse to publish (or even review) any papers involving research that relied on data and rights to publish that was controlled by pharmaceutical companies. Should this occur, we can probably expect future issues of these journals to be relatively thin. Not only would there be fewer papers to publish, I suspect that there will also be fewer advertisements to navigate around.
Most of the clinical drug trials that I have seen conducted in our institution are multi-centre in nature and a quick review of the protocols reveals that, in many cases, the data generated is considered to be the property of the sponsoring company. Just ask Dr. Nancy Olivieri about this situation. By the way, congratulations to Dr. Olivieri are in order for her Civil Justice Foundation award for exposing the dangers of deferiprone.
Let’s remember a few realities:
1. Industry is a major sponsor of drug research and publication.
Pharmaceutical companies spend over US$40 billion annually on research and development. (1) Let's face it, industry involvement in research will exist as long as there is profit in pharmaceuticals. For the sake of health care advancement, let's hope that the spirit of capitalism always accompanies drug development. The pace of progress would slow dramatically without it. At the same time, we need to avoid potential conflict of interest while "dancing with the porcupine". (2) Glassman et al (3) recently described the outcome of a study in which these investigators randomly sampled six professional medical society journals to determine if revenue generated from pharmaceutical advertisement creates potential financial conflicts of interest. The authors reported that estimated advertising revenue for these journals ranged from $715,000 - $18,630,000. More importantly, 4 of the 6 nonprofit physician organizations raised as much or more from pharmaceutical advertising as they did from memberships. They concluded that potential financial conflicts of interest may be substantial, although the impact on professional societies’ financial independence and behaviour is still unknown.
2. Not all research conducted is published.
As Bardy demonstrated in his 1998 review of 274 clinical trials, selective reporting of trials with positive outcomes should be expected. (4) Ioannidis revealed in his report of the same year, clinical trials with positive results are submitted and published more rapidly after study completion than negative trials. (5)
3. Not all peer-reviews are created equal.
As Link identified in her 1998 retrospective analysis of two years of original submissions received by the journal Gastroenterology, reviewer bias is a real possibility. (6) This investigator found that while US and non-US reviewers evaluate non-US papers similarly, they tend to evaluate papers submitted by US authors more favourably. In particular, US reviewers appear to have a significant preference for US papers. Potential bias exists in many forms. (7) Be wary.
4. Not all published research is good research.
There are too many examples of this to cite.
5. Not all data collected is presented.
Information that is missing is often as important as the facts that the investigators and publishers have selected to provide. This is a particular problem with the reporting of adverse drug events. (8)
Bottom line, don’t believe everything you read. As Lewis et al (2) point out in their recent commentary regarding university-industry relationships, the duty of universities (and I would extrapolate this to include all health care researchers) is to seek the truth, while the duty of pharmaceutical companies is to generate revenue for their shareholders. Keep this in mind and you'll be able to safely navigate the minefields of the published literature.
The Editors join the nation and the rest of the world in offering condolences to those affected by the attacks in the US. Our thoughts and prayers are also with the allied forces who have joined the action against terrorism. And let's all remember FDR's words as we lead our private, and our professional lives.
J. Jewesson, PhD
J Inform Pharmacother 2001;7:1.
Anon. Look, no strings: publishing industry-funded research. CMAJ 2001;165:733. (Online)
Lewis S, Baird P, Evans RG, Ghali WA, Wright CJ, Gibson E, Baylis F. Dancing with the porcupine: rules for governing the university–industry relationship. CMAJ 2001;165:783-5. (PubMed)
Glassman PA, Hunter-Hayes J, Nakamura T. Pharmaceutical advertising revenue and physician organizations: how much is too much? West J Med 1999 Oct;171:234-8. (PubMed)
Bardy AH. Bias in reporting clinical trials. Br J Clin Pharmacol 1998;46:147-50. (PubMed)
Ioannidis JP. Effect of the statistical significance of results on the time to completion and publication of randomized efficacy trials.JAMA 1998;279:281-6. (PubMed)
Link AM. US and non-US submissions: an analysis of reviewer bias. JAMA 1998;280:246-7. (PubMed)
McCormack J, Jewesson P. The influences around us - be wary of writers' biases. J Inform Pharmacother 2001;4:1. (Online)
Loke YK, Derry S. Reporting of adverse drug reactions in randomised controlled trials - a systematic survey. BMC Clin Pharmacol 2001;1:3. (PubMed)
Copyright © 2001 by the Journal of Informed Pharmacotherapy. All rights reserved.