Saturday, June 2, 2012

The Harm of Not Seeing Drug Reps

Now more than ever, the growing consensus among many is that doctors should avoid seeing pharmaceutical sales representatives, otherwise known as drug reps. A position statement from the AAMC, the head organization of all US medical schools and residency programs, recommends that all academic health centers avoid having drug reps on their campuses, hospital and clinics.  Many medical institutions including the VA and Kaiser have also enacted similar policies banning drug reps.  In fact, the number of doctors willing to see reps has declined about 20 percent since 2008. In 2010, about 11 percent of American physicians had “severe” or “no-see” restrictions on drug rep access, while 34 percent had “some” restrictions.

The rationale for such bans is that drug reps are really marketing agents for the drug companies they represent, and their mere presence will cause physicians to write unnecessary prescriptions. It is not only the sales pitches that certain stakeholders are concerned about, but also drug samples and often times food that comes with them. The idea is that gifts from the industry (which other than meals have not been around for some time) as well as samples of medicines, marketing material and sales pitches from drug reps will influence physicians to write medications that they might not normally write.

There is certainly some data to support this rationale.  It is indisputable that marketing from drug companies increases sales of their products.  Not only are there studies to back this up, but also at face value, if it didn’t work, the industry wouldn’t do it.  The real question is whether or not this is good or bad for patients.  Certainly, if a doctor writes for an expensive brand name medication, when a generic medication would have worked just as well for a lot less money, then pharmaceutical marketing is harmful.  On the other hand, if a doctor is not prescribing a medication that he should be writing for or the current cheap, generic medication the patient is taking is not working or is causing unnecessary side effects, then drug company marketing which would change those prescribing practice might actually be helping the patient.  There are probably several examples of both extremes. For example, Singulair is a $3 billion dollar product for Merck and the single best selling controller medication for asthma, but it doesn’t work any better than over the counter generic medications for allergies, and the NIH guidelines consider Singulair alternative therapy for asthma (inhaled corticosteroids are first line, yet rarely prescribed). Marketing and subsequent sales of Singulair are probably not good for patients. On the other hand, cardiovascular disease is the single leading cause of death in the US. However, many physicians had been prescribing less effective, generic statins to patients at risk for heart attacks, and in many cases not meeting therapy goals and causing side effects.  Recently, the FDA released warnings about using higher doses of generic simvastatin.  Thus, the Pfizer rep promoting branded Lipitor (it has since gone generic and is no longer promoted) with their $4 coupon cards was probably helping patients.

The overall benefit or harm of pharmaceutical marketing is unclear. At issue is whether or not a pretty drug rep, with slick marketing material, a drug sample and a slice of pizza is enough to sway a physician to write for a prescription that is not in the patient’s best interest.  Despite many claims that this is indeed the case, there is no real evidence to back this up.  Part of the reason for this is such studies are incredibly challenging to design and implement. The one review paper that is often quoted in support of this claim actually never really showed this.  Their one example was a study done in the Netherlands where physicians read hypothetical marketing material and picked a therapy.

However, what about the harm of NOT seeing drug reps? Do the restrictive policies enacted in the last few years have any unintended consequences? Though there is no question that the motivation of the drug reps and the industries they represent is to sell prescriptions, they also provide physicians with information about new products and new data on existing products. Given the complexity of medicine and the vast amount of new data available each day, it is difficult for physicians to keep up to date, especially in primary care.  Thus, a benefit of the drug reps is providing physicians with important new information. Therefore, the potential risk of not having drug reps is not having, or more importantly doctors not acting on, new information.

Though it has (surprisingly) drawn very little attention, a recent study looked at this very issue.     In a study recently published in The Journal of the American Society of Hypertension called “Can Access Limits on Sales Representatives to PhysiciansAffect Clinical Prescription Decisions? A Study of Recent Events With Diabetesand Lipid Drugs,” the authors used a very sophisticated methodology and study design to look at the potential harm of physicians not seeing drug reps.  They decided to look at three prescribing practices:
1. Adoption of a new, first in class diabetes medicine (Januvia) in 2006 (sample size over 65,000 physicians)
2. Decreases in prescribing Avandia after the FDA placed a box warning on it in 2007 (sample size over 58,000 physicians)
3. Decreases in prescribing Vytorin (a combination of simvastatin and Zetia) when a 2008 study was released that showed no benefit over simvastatin alone in a large, randomized trial (sample size over 72,000 physicians).

The researchers used IMS data of actual physician prescriptions to analyze prescribing patterns of the specific drugs in questions. They used a consulting firm data base of how many times a drug rep saw 300,000 physicians to determine access level (drug reps keep very careful records of their sales calls, since this is how they are paid), and divided physicians into four categories: very low access, low access, medium access and high access.  They also only used docs who were high prescribers of diabetes and cholesterol medicines to control for the fact that low prescribing doctors are often not targeted by sales representatives.  They also controlled for other variables such as specialty and geography.

What they found were that physicians with very low access to representatives had
the lowest adoption of the new diabetes medicine, taking 1.4 times longer to prescribe than the low access physicians and 4.6 times longer to prescribe than the medium access physicians. In response to the Avandia box warning, docs with very low access were 4.0
times slower to reduce their use of Avandia than those with low access. Similar numbers were seen with prescriptions of Vytorin after negative data was released.  The study also showed that the physicians who were most sensitive to the effects of the pharmaceutical reps were primary care physicians. Cardiologists were least affected.  In other words, docs who didn’t see drug reps were about 4 times less likely to respond to either positive (new drug available) or negative (safety issues, lack of efficacy) information than docs who allowed some access to pharmaceutical representatives.

Bottom Line: Pharmaceutical marketing increases pharmaceutical sales which ultimately increases what we spend on health care.  Whether or not this is good or bad for the individual patient or society is debatable. While there may be overuse of some branded prescription products, there is certainly under use of branded products as well.  After all, prescriptions drugs do cost money but they also save lives.  Unfortunately, there is no clear evidence to determine the overall risk or benefit of pharmaceutical marketing one way or another. However, while restricting drug reps may decrease pharmaceutical sales, it may also have the unintended consequence of decreasing access to new and important information for physicians. In this first of its kind study, docs who didn’t see drug reps were more likely to prescribe less effective and potentially more dangerous drugs to their patients after new data was available.

Medical information comes from many sources. Though information provided by drug companies is intended to increase sales, it doesn’t mean that it is not valuable.  The question is whether you want your physician to have the most up to date information and trust him or her to interpret the data, regardless of who is providing it, and use it in the best interest of the patient; or whether you don’t trust physicians (especially when pizza or pens are involved) with any information provided by drug companies, so you restrict access to this information.  We at least have one study suggesting that there are some potential harms to restricting access to information that drug companies provide, and so maybe we should trust doctors a little more.