While some people may believe that pharma companies can just exert their financial power in order to land their drugs on the latest medication guidelines, that is simply not true. Instead, here are three approaches that a company can take to help sway a doctor’s decision.
A recent article in the Milwaukee Journal Sentinel titled, “Doctors with links to drug companies influence treatment guidelines,” found that many guideline panels include physicians with financial ties to the industry. According to the paper, these findings “offer the latest glimpse into how pharmaceutical companies, with billions in sales at stake, exert a powerful but often unrecognized influence over the practice of American medicine.”1
While disclosing conflicts of interest remains a real problem, I am certain the pharmaceutical industry only wishes that it could influence guidelines the way these and other critics believe they can. Most guideline panelists who do have ties to the industry are not only renowned experts in a particular disease but have also done research for multiple companies that produce many related products. Thus it is highly unlikely that a panelist would wrongly promote a product or class of medications without supporting evidence simply because it received compensation for consulting or research.
However, the pharmaceutical industry would be wise to consider how it might actually influence guidelines. Despite a plethora of guidelines which sometimes conflict—and some negative attitudes about guidelines as a form of cookbook medicine—for most physicians a medication being on a reputable guideline has a substantial amount of weight. From a physician’s perspective there are a few approaches that the industry could take to gain entry onto a guideline while simultaneously promoting its product.
1. Comparative research: Because the FDA considers superiority over a placebo to be sufficient for efficacy, it is not surprising that the industry funds few studies that compare its product to the current standard. However, in order to be included on a guideline, performing better than a placebo is usually not enough.
2. Outcomes research: Demonstrating hard outcomes such as heart attack and death are difficult because these studies require a large number of patients and take many years. However, evidence of improvement in outcomes (and not just surrogate markers like low-density lipoprotein (LDL) and A1c) are a sure way to get a product used and recommended in a guideline.
3. Focus on patient-related issues such as adherence, safety and side effects: It is important to recognize that safety can be just as important as efficacy. Most oral diabetes medications are equally effective but side effect profiles are quite different. Medications are only effective if patients take them. Yet, there is very little research on adherence. But evidence supporting improved safety or adherence would increase the likelihood of a guideline recommendation.
The bottom line is that (despite what the public and media may think) involving guideline panelists in your research and advisory boards is not a very effective way to get a product recommended on a guideline. Rather, the best way to get on a guideline is to generate evidence that is meaningful to both patients and providers.