Veterinary drug marketing: Understanding the spin (Proceedings)

Modern veterinary practice relies on a wide range of pharmaceutical products in order to provide optimum patient care and well-being. Information about veterinary drugs, both new and old, is constantly produced. Some of this information is buried deep within scientific journals or text books, but much of it is presented openly to veterinary clinics. This information is vital to educated and rational use of drugs as clinical conditions change and new situations arise. However, like any competitive industry, veterinary pharmaceutical companies need to market their products in an attempt to influence consumers to use them. In the case of prescription drug companies, the "consumer" is the veterinary clinic that orders and prescribes them. Federal agencies place restraints on the claims a company can make about its product, so only certain attributes can be advertised. Regardless, all marketing campaigns will attempt to place their product in the best possible light. Pharmaceutical marketing can come in many forms, be it ads in vet journals, brochures at conferences, or direct meetings with drug company reps. Like any knowledgeable consumer, veterinary staff must be able to look past the "sales pitch" and critically evaluate the product.

Although veterinary technicians do not prescribe these medications, in many clinics they will meet with company representatives, read the product literature, and be involved in the drug ordering process. The purpose of this presentation is to help veterinary technicians better evaluate the pharmaceutical information that is out there. This can sometimes be a daunting task, especially when the literature is filled with complex pharmacology. However, there are a few strategies that can help technicians play a critical role in a veterinary clinic's overall pharmaceutical strategy.

Ask yourself 3 related questions whenever presented with pharmaceutical information

1. Is this data RELEVANT to the care of my patient?

2. Is this data CREDIBLE to others in the scientific community?

3. Is this treatment APPROPRIATE for this situation?

1. Relevance to typical patient conditions

There are numerous cases of pharmaceutical advertising where the data presented is not relevant to the context to which it is applied.

Efficacy data When a marketing campaign touts the efficacy of a product, be sure to carefully examine what criteria are used to define efficacy. Sometimes these criteria may not be relevant for predicting CLINICAL success. For example, many antimicrobial drug trials use in vitro experiments as surrogate measures for clinical efficacy. However, there are many reasons why impressive in vitro results may not accurately predict clinical success. % kill in a petri dish is not the same as a clinical cure in a dynamic physiological system! Also be sure to note the conditions under which the experimental data was obtained, and ask yourself if these conditions are realistic. For example, a new antimicrobial for bovine pneumonia was launched, touting its exceptional activity in the lung. However, this activity is based on a specific in vitro pH, and the drug is much less effective in other, more acidic environment (possibly like a pneumonic lung?) This doesn't mean the drug will be ineffective for treating pneumonia, but the in vitro conditions were selected to optimize the drug's activity rather than reflect the pathology you are actually treating.

Comparisons to competitors Many ads will tout the superiority of their product over others, often citing credible literature sources. However, the relevancy of these comparisons can be questionable. In some cases the competitors' products are compounds related or similar to the advertiser's product. For example, some ads tout the superiority of their fluoroquinolone over other fluoroquinolone products. These ads assume that the practitioner only has fluoroquinolones from which to choose an antimicrobial therapy! Another example is a comparison between only COX-2 selective NSAIDs. Could a nonselective COX inhibitor work as well in this case? Or the opposite situation may be presented, where one product is compared against others that are obviously unsuitable for the case presented. Ask yourself (or the drug rep!) why these particular products were chosen for comparison and not others. Remember, a comparison is only going to be made if it makes the advertiser's product look favorable.

Pharmacokinetic and Pharmacodynamic (PK/PD) parameters Some marketing campaigns describe the PK parameters of their product, such as plasma or tissue drug concentrations (Cp/t), volume of distribution (Vd), elimination half-life (T1/2elim), or bioavailability (F). These parameters have NO RELAVENCE without a proper physiological context! Don't become overwhelmed by company literature using fancy PK terms—they are not the only (or best) way of evaluating a new product. One common strategy is to present a drug with a higher concentration in a specific tissue as more effective than a competing product. However, the relative merit of high plasma versus tissue concentrations is still an area of debate among pharmacologists, so don't take plasma or tissue concentrations as an absolute predictor of efficacy. For example, bacteria in urinary tract infections may be located strictly in the urine or invade the bladder epithelium, as in uropathogenic E. coli. It is likely that both urine and bladder tissue drug concentrations are relevant. Finally, a note about minimum inhibitory concentrations (MICs) of antimicrobials for a particular bacterial species. MIC data by itself is not relevant! An antimicrobial with a lower MIC is not necessarily more efficacious than another antimicrobial with a higher MIC. Predictions of efficacy (and they are just that, predictions!) require knowledge of drug pharmacokinetic properties in relation to the MIC, such as Time > MIC, Cmax/MIC or AUC/MIC. A drug with a lower MIC may also have PK characteristics that make treatment success unlikely.

2. Credibility of data

Not all information in pharmaceutical advertising is of the same quality! Be sure to examine the sources of the data provided.

Properly performed clinical trials One of the reasons that pharmaceutical companies rely on in vitro or non-clinical experiments is that properly designed, implemented, and analyzed clinical trials are very difficult to perform. In fact, complete clinical trial analysis is probably beyond the time constraints of anyone in a busy veterinary clinic. However, there are a few quick criteria to check in any clinical trial:

• Were the samples randomized?

• Is a control group (placebo or comparison product) used?

• Were the investigators/clients blinded during the study?

Supporting evidence Is there any other data in the literature to support the claims of the product? Is all the information presented "company data" or have independent trials been performed? Other trials may provide supporting data that was obtained under different circumstances, or may refute the company's claims. As well, other trials may describe a different indication or dose of a particular compound, or document adverse effects not seen elsewhere. A quick PubMed or VIN search is an efficient way to look for the latest data, and many veterinary/pharmaceutical journals are available online, sometimes for free!

Statistics This can sometimes be difficult to analyze, but is often essential for determining the credibility of a study's conclusions. Are the results statistically significant? If so, are they clinically significant? (These are NOT the same!) Was an appropriate sample size used? Is there substantial inter- or intra- animal variability in drug concentrations or clinical success? Often the "mean" value is reported in ads, but a wide variability can result in many patients are not receiving optimal drug management.

3. Appropriateness of treatment

Just because a pharmaceutical advertisement says we CAN treat a condition with a certain drug doesn't necessarily mean we SHOULD treat it that way.

Antimicrobial resistance (AMR) If a marketing campaign is promoting a certain antimicrobial for a specific condition, what do you think are the long-term consequences of this usage in terms of AMR? Some newer antimicrobials are promoting first-line use to reduce chances of "treatment failures", and insinuating damage to the clinic's image if treatment failure occurs with older antimicrobial usage. This is not a rational method of selecting a proper antimicrobial, and certainly does not consider the importance of AMR!

Cost/benefit analysis Some products may be advertised as supplemental or accessory medication to along with pre-existing treatment regimens. Is there a therapeutic benefit to be gained by this? If 80% of patients respond favorably to the standard treatment, is it worth adding another medication to increase that number to 90%? Are there increased risks of adverse effects with more drugs, and will client compliance decrease with increased drugs used?

Several considerations and techniques are discussed for properly evaluating veterinary drug information. Specifically, the relevance, credibility, and appropriateness of the information must be analyzed.

References

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Gunderson BW, Ross GH, Ibrahim KH, et al. What Do We Really Know About Antibiotic Pharmacodynamics? Pharmacotherapy 2001;21:302S-318S.

Hulley SB, Cummings SR, Browner WS, et al. Designing Clinical Research, 2nd Ed. Philadelphia: Lippincott Williams & Williams, 2001.

Lees P, Cunningham FM, Elliott J. Principles of pharmacodynamics and their applications in veterinary pharmacology. J Vet Pharmacol Ther 2004;27:397-414.

McKellar QA, Sanchez Bruni SF, Jones DG. Pharmacokinetic/pharmacodynamic relationships of antimicrobial drugs used in veterinary medicine. Journal of Veterinary Pharmacology and Therapeutics 2004;27:503-514.

Toutain PL, Lees P. Integration and modelling of pharmacokinetic and pharmacodynamic data to optimize dosage regimens in veterinary medicine. Journal of Veterinary Pharmacology and Therapeutics 2004;27:467-477.