Where's the beef? How pharmacists can take a bite out of bias

April 28, 2015

What if P&T committees choose drugs on the basis of bias-prone info? What part is played when corporate funding supports academic research? And what can pharmacists do about it?

 

David EngenMost Americans can’t resist a big, thick, juicy hamburger. Myriad mouth-watering toppings await the consumer as fast-food and restaurant chains test the limits of creativity to satisfy our carnivorous cravings. With unlimited fixings available, what could possibly ruin the ultimate hamburger? 

Fake meat

No offense to those who advocate reduction of global meat consumption. Although alternative meat sources have made great strides toward pleasing the palate, it is not likely that the multibillion dollar burger business has survived on selling tofu.1 It’s all about the beef, baby.

In analogous fashion, has modern medicine mistakenly substituted a beanburger in the healthcare meal deal?

High stakes for high-priced steaks

Historically, the influence of the pharmaceutical industry on healthcare was thinly disguised. Stories of elaborate Pharma-sponsored tropical “medical conferences” and extravagant five-star “educational dinners” in exchange for preferential prescribing practices pervaded physician culture. Studies indicated that 80% to 95% of doctors were seeing drug company representatives on a routine basis.2

The approach seemed to work like a billion-dollar charm as retail drug spending and drug company profits soared.3 After all, as long as the drugs were safe and effective, what was the harm in giving away a few freebies and brand-name samples in exchange for an edge on the competition? One key word: Bias.

Evidence-based or evidence-biased?

Bias can lead to unreasonable prescribing of certain branded drug products despite a lack of clear benefit over more cost-effective alternatives.4

Rogue prescribers are often kept in check by hospital-system pharmacy and therapeutic (P&T) committees through formulary restrictions and education. But what if the very information the P&T committees use as the basis of their drug selection is prone to bias?

Corporate funding of academic research has great potential to undermine evidence-based healthcare. Many teaching hospitals and medical schools are sensitive to drug company tactics and have publicly distanced themselves from industry bias.5 Yet critical appraisal of contemporary published medical literature indicates that the influence of Big Pharma may be more deep-seated than many have realized.

During the early 1990s, sources within the U.S. Institute of Medicine claimed that roughly 4% of medical treatments were based on strong evidence, and over half of all services were backed by very-weak-to-no evidence.6

Today, it is estimated that fewer than than 10% of randomized controlled trials published in medical literature are able to pass the tests for validity or clinical usefulness.7

 

Devil in the details

Unfortunately, even our trusted peer-reviewed medical journals are prone to bias. Recent studies have found that many published randomized controlled trials (RCTs) have major issues with methodology.8

For example, among major journals (JAMA, NEJM, BMJ, Lancet) which identified an RCT in the abstract,

• 29% did not define the primary outcome

• More than half did not report treatment harms

• >90% did not specify how (or whether) subjects or assessors were blinded throughout the study

With 86% of these studies failing to address the lack of subject follow-up, on what clinical hook are we hanging our hats? Not to imply that all published medical literature lacks usefulness,9 but many of today’s clinical trials have serious limitations and design flaws, which should be matters of major public concern.

Before directing our patients down the road to better health, pharmacists ought to make the best effort to give the most direct and safest route possible.

USDA choice recommendations

To beef up effectiveness of our role on the healthcare team, pharmacists should make a coordinated effort to address lifestyle modifications before advocating a new drug to treat a patient’s health condition.

All medications have potential side effects and risks, some of which could be worse than the condition itself. Today’s “super-sized” Western mentality would have us believe that more healthcare (and more medications) will make for better healthcare. This thought pattern can lead to overdiagnosis of common ailments and unnecessary prescribing of pharmaceuticals.

We can help change this trend by making sure our patients realize the proven benefits of the positive health choices that are under their control: smoking cessation, stress reduction, good sleep hygiene, balanced eating selections, and increased physical activity.

The latest and greatest is not always better than the tried and true. Investigate, then communicate … use your golden opportunity to make a whopper of a difference.

References:

1. USDA cattle and beef statistics. http://www.ers.usda.gov/topics/animal-products/cattle-beef/statistics-information.aspx. Accessed online 4/21/2015.

2. Lexchin J. What information do physicians receive from pharmaceutical representatives? Can Fam Physician. 1997;43:941–945.

3. Moynihan R. Who pays for the pizza? Redefining the relationship between doctors and drug companies. 1: Entanglement. BMJ. 2003;326:1189–1192.

4. Hong SH, Shepherd, Scoones D, et al. Product-line extensions and pricing strategies of brand-name drugs facing patent expiration. J Manag Care Pharm. 2005;11(9):746–754.

5. Austad KE, Avorn J, Franklin JM, et al. Changing interactions between physician trainees and the pharmaceutical industry: A national survey. J Gen Intern Med. 2013; Aug 28(8):1064–1071.

6. Field MJ, Lohr KN (eds). Guidelines for clinical practice: From development to use. Washington, DC: National Academy Press, 1992.

7. Strite, SA, Stuart, ME. Basics for evaluating medical research studies: A simplified approach. Delfini Publishing Group LLC, 2013.

8. Berwanger O, Ribeiro R A, Finkelsztejn, A, et al. The quality of reporting of trial abstracts is suboptimal: Survey of major general medical journals. J. Clin. Epidemiol. 2009 Apr;62(4): 387–392.

9. Steinhauser G. The nature of navel fluff. Med Hypotheses. 2009 Jun;72(6):623–625.

David Engenis a clinical pharmacist care manager in northwestern Oregon. E-mail him at pharmojo@gmail.com.