Sunday, July 31, 2005

Detailing, samples, prescribing, and outcomes

Kevin MD and Blogborygmi cited this article about the influence of drug sampling on residents’ prescribing behavior. There have been numerous articles of this sort, showing various effects of detailing and sampling by pharmaceutical companies, and considerable controversy has been fueled. Many of the citations have been compiled at No Free Lunch and Healthy Skepticism, organizations which are critical of pharmaceutical industry marketing. Some would like to see marketing disappear as we now know it, and are calling on physicians to refuse to accept literature or even small gifts from drug sales representatives. Others would reduce or curtail the pharmaceutical industry’s support of physician CME.

Most all the critics cite the studies as evidence to back up their recommendation to drastically change the landscape of drug company promotion. But is this evidence strong enough to warrant such a recommendation? Check the above web sites, link to the articles and decide for yourself. At the risk of oversimplification the gist of the studies is that physicians’ prescribing behavior is influenced by pharmaceutical industry promotion. That is, marketing works. Some of the studies suggest that the promotions even influence doctors to prescribe outside established guidelines.

But as I browse this extensive collection of links I discover a weakness. I can not find one study about patient outcomes. Only the surrogate endpoints are examined. So, we can learn a lot from these studies about the effect of marketing on doctors’ attitudes and prescribing behaviors, and it’s all very interesting---indeed fascinating---but what about the clinical bottom line? Unfortunately, research to date provides no answers.

Our adventure in evidence-based medicine has taught us about the hazard of reliance on surrogate endpoints. In the 1970s we knew that surrogate hemodynamic endpoints in heart failure were adversely affected by beta blockade, and were taught that beta blockers were bad for heart failure. Only after years of outcome based studies did we realize we were wrong. We also knew that ventricular arrhythmias were harmful, and that since the surrogate endpoint of frequency of ventricular arrhythmias could be decreased by treatment with Class I-C antiarrhythmic drugs, such treatment must be a good thing. Not until completion of the first adequately powered outcome based study, CAST, did we know how tragic such thinking was.

So while the science concerning the effect of drug company promotion is soft, many observers still think the impact on patient outcomes is negative. Although promotions are certainly biased and the material can be deceptive, the information doctors receive is a mixture of good and bad. Must we assume that the bad influence outweighs the good, or is the reverse equally plausible? We must resist simplistic assumptions. Out in the real world varied and sometimes opposing factors are at play. For example, although Vioxx was heavily promoted and associated with harm there are other examples in which drug companies promote numerous beneficial therapies that are evidence-based and known to be under-utilized such as beta blockers and ACE inhibitors for heart failure and low molecular weight heparins for deep vein thrombosis prophylaxis [1] [2] [3]. [4] [5] [6] [7] Who knows how it all balances out?

I don’t rely on drug reps or promotional material to keep current, nor should anyone. There’s no need. Present day information technology makes it unnecessary. We can easily get good quality unbiased information at the point of care. However, a sweeping prohibition against drug reps, samples and industry supported CME is not supported by high level evidence. The jury is still out.


rglacsamana said...

RW, how do you propose to measure patient outcomes?

I believe the principal concern here is not so much those outcomes as the perception that doctors are being unduly influenced by this heavy promotion, often forgetting to rely on more reliable sources for information and to instinctively prescribe those products being peddled to them. One consequence of this is prescribing products that are much more expensive and don't offer any advantage over existing but cheaper drugs.

Does Nexium, for example, do a better job than Prilosec, which is much less expensive and is not much different than the new drug?
I can cite countless similar examples, but you get the idea.

One of the problems we have here is the unscrupulous pricing of drugs, particularly when new. One way Big Pharma keeps amassing those humongous profits from year to year is this heavy advertising, which is the reason the AMA and the drug companies drafted more strict rules to curb this incestuous relationship between physicians and drug reps.

More and more physicans are starting to shun these ubiquitous drug reps, and I think this is a healthy development. I'm not sure drug advertising to doctors will completely vanish, but it's much better to limit its scope.

Anonymous said...

You Have Now Been Sampled
While the pharmaceutical industry’s image and reputation has and appears to continue to suffer, added damage has expressed itself with costly patent expirations. Yet the big pharma task forces still insist that reps provide incredible value, and the more the better, as the drug reps are the givers of gifts, and reciprocity in the form of prescriptions just has to occur.
As a big pharma ex drug rep for over a decade, which during that period the number of drug reps actually tripled, the drug rep’s vocation has become more ridiculous, and possibly void of any true sense of accomplishment due to their customers preventing them from interaction or even presence in order for the drug reps to follow directives of the health care givers, and not their own employers, which is to influence their prescribing habits via direct dialogue along with the giving of gifts. The job has become nothing more than doing lunches and leaving samples at offices, for the most part. My perception formed from my own analysis of how drug reps operate in today’s environment in the medical community has led me to draw such conclusions, which I believe to be accurate.
So they may be named at times in different ways, these promoters will be referred to now only as drug reps, which number close to 100,000 in the U.S. presently to influence close to 1 million prescribers in this country, it is believed, yet is probably less now due to big pharma cutting thousands of reps recently. The cost to the pharmaceutical industry of these drug reps is around 5 billion dollars a year. Income for each rep grosses close to or above 100,000 grand a year on average, along with great benefits and a company car, as well as stock options as they gladly work from their homes and set their own hours, which I understand is much less than 8 hours a day.
The main function these days of drug reps, I believe, is primarily to offer doctors various types of inducements of a certain value that are not gifts, but bribes, by definition. The drug sampling of doctors may be considered an inducement, and a rather valuable one for the drug rep, as many believe that these samples are what ultimately influence the doctor’s prescribing habits over anything else, including statements from drug reps. This may be why the drug industry spends around 20 billion every year on samples. Yet I want to be clear on what I am saying: drug reps are some of the smartest people you will meet that do in fact have great paying jobs with great benefits. Most importantly and my opinion, I believe most reps really WANT to do well for their employers, yet are prohibited from doing so now because of how their employers are now viewed in their medical community.
Many years ago, drug reps have used their persuasive, yet ethical, abilities to influence the prescribing habits of doctors in an honest and ethical manner, as they focused on the benefits for the doctor’s patients with a particular drug that the detailer may promote to such a doctor. However presently, most health care providers now simply prevent drug reps to speak with them- now this is especially true when they are in clinic treating and assessing patients. More and more medical establishments are completely banning drug reps from their locations, and I speculate that this is occurring for many reasons, which may include the following:
The doctors lose money. Doctors are normally busy, so their time is valuable. As a drug rep, you are an incredible waste of their time. Yet they will accept your samples still. The credibility you possibly have thought you had and were perceived as such by doctors as a drug rep is no longer viewed to exist to any noticeable degree by the prescriber. For example and this is based on my experience and my colleagues, doctors view any information you may provide to them as biased and embellished. In my opinion, based on information and belief, their view regarding their assessment of you as a drug rep is accurate due to the statistical gymnastics the employers of drug reps engage in, which effectively and ultimately is permitting and encouraging the drug reps to lie to the doctor and likely are unaware of the statements stated by them are misleading. Doctors by their very nature seek answers objectively. And doctors do in fact find out about drugs through other methods besides the representative of the drug’s maker, such as the internet and experience with certain medications. Most drug reps in this country in particular mostly hire drug reps based on such qualities as the candidate’s looks as well as their personality, overall. Furthermore, it is possible that pharmaceutical companies desire their drug reps to be obedient and to not question what is asked of them. Upon speculation, this can be possibly determined by the background of the candidate, which may indicate they seek popularity as well as are money driven. In addition, most drug reps do not have degrees remotely related to any aspect of anything of a scientific or clinical nature.
During my decade as a drug rep, I would encounter on very rare occasion another rep that may have been a nurse or researcher, and this is concerning that others do not have similar backgrounds because the type of training necessary is rare for a drug rep. In fact, based on my opinion, many do not particularly care to acquire education related to such medical or clinical topics. They learn the basics in order to sell their promoted products. Yet anyone who has ever worked with doctors in a clinical setting, or in a hospital working in a clinical nature, likely they would agree that a drug rep should want to and seek all related to the complexities involved in the restoration of another’s health.
Many drug reps, it is believed, are void of any complete interest in medicine completely, and I believe this to be necessary. In addition, ethical considerations due to their possible deliberate ignorance created by the necessity of what they are required to say or do by their employers may be viewed as a disturbing fallacy as well. This allows them with the encouragement and coercion of their employer to embellish the benefits of their promoted products at times in addition to offering inducements to doctors in various ways- most of all of which are rather covert, yet performed and issued to select prescribers upon instruction of their employer. Examples may be creating a check from your company to a certain supporting doctor and handing this check to thank a doctor for supporting your company’s products for doing little if anything for your employer to justify this check. Or tangible items are given to such prescribers, such as TVs or DVDs which may or may not be utilized in a particular doctor’s office. It happens often, such activities.
From the drug rep’s perspective, it is unlikely they will even consider the possibility to question their pharmaceutical employer due to the great risk of losing income and benefits that they are unlikely to acquire at another place of employment. Because of their consistent and conscious effort to keep their high-paying jobs, the drug reps always appear overtly anxious to please their superiors- regardless of any ethics or legalities regarding any activity they may be required to perform. With big pharma in particular, each drug rep is given a variety of budgets, such as a chunk of cash for doctor office lunches that they are required to spend in a certain period of time. Another chunk of cash may be assigned to a rep to pay assigned or registered speakers of their employer to speak to other prescribers about a disease state related to the drug rep’s promoted product. These activities, in my time with big pharma, were never monitored or questioned by managers or superiors. What I did notice is that my annual raises were greater than others according to the amount I spent for that particular year, as this, according to a big pharma company, was a very objective and noticeable variable with securing and keeping your employment in big pharma.
While legally risky, the drug companies continue to dispense to their reps these large budgets their drug reps are in effect coerced to dispense with complete autonomy and possibly the spending can be fabricated, which is too complicated to fully explain. This design perhaps is why there are now various state and federal disclosure laws that are presently being considered to mandate the release of all funds dispensed from pharmaceutical companies as far as why a company’s funds were spent and for what reason or method. Because, according to the lobbyists of pharma companies, they consistently insist that whatever they spend always is for the benefit of public health. As mentioned earlier, presently such activities are quite covert. Yet if such laws are mandated, it is likely the accounting of pharma companies will become rather creative and incomplete. In summary, as a big pharma drug rep, my budgets were unlimited, and I typically spent more than I made though the activities I have mentioned so far. And this is not an isolated case.
Another issue is what is referred to as data mining. The American Medical Association sells this prescribing data on individual doctors to pharmaceutical companies or pharmacies, by providing others identifying numbers of a particular doctor, such as a state license number or DEA number, which allows them to track the scripts a doctor writes not far from real time availability. This data shows the volume of scripts of a particular doctor and what the doctor has been prescribing for the doctor’s patient for their disease state, and this data reveals competitor products to the drug rep as well. Aside from being deceiving and dishonest, the data allows a pharma company to ‘reward’ those doctors who support their products, while treating the other doctors with ‘neglect’, which means the non-supporters of a pharma company will not receive any inducement or remuneration from a particular pharma company. The data, by the way, only reflects numbers linked with particular products, and fortunately is free of patient names- this data that is provided to all drug reps. What has been described is the method typical with all big pharma companies, in my opinion, and I worked for three of them. It appears to be manipulative in a psychological paradigm- a combination of Pavlovian responses combined with positive and negative reinforcement.
So such methods create a toxic culture required to be absorbed by those members of such a pharma company. Furthermore, the tactics implemented by pharma companies vacuum the judgment of prescribers, which may prevent patients from receiving objective treatment. Yet on the most basic level, it is the samples left with prescribers that ultimately determine their prescribing habits- with various inducements to some doctors running close in second place. Yet remarkably, prescribers are prescribing more and more generics, which typically are not sampled to prescribers. I find this comforting that the manipulation efforts of the pharma industry are not as effective as they believe they are in a rather delusional way. Yet what is happening now in regards of branded meds vs. generic meds, insurance companies are flat out paying doctors to switch patients to a generic if one is available, as well as initiating generic medication treatment for their patients. I speculate they are paying doctors for this as a response of what pharma has been doing for quite a long time. From a clinical paradigm, if a medication is providing desired treatment and good tolerability for a particular patient, one could argue it would be unethical to switch treatment for financial gain, further complicated by the fact that most patients are aware that insurance company payments to doctors for this even occur.
It is likely and I believe that most drug reps are good and intelligent people who unfortunately are coerced to do things that may be considered corruptive to others in order to maintain their employment. In other words, the drug reps have compromised their integrity, ultimately.
It seems that external regulation is necessary to prevent the drug companies from allowing the autonomy of drug reps that exists, with their encouragement, which forces the reps to do the wrong thing for the medical community, possibly. Because it is obvious that internal controls with such corporations exist on paper often, but clearly are discouraged to be enforced. It is possible that these pharma companies falsely believe that being an ethical company would make them a company without excess profit. One can only speculate on their true motives. Yet it appears that overt greed has replaced ethics with this element of the health care system, which is the pharmaceutical industry, as illustrated with what occurs within these companies. However, reversing this misguided focus of drug companies is not impossible if the right action is taken for the benefit of public health. Likely, if there are no drug reps, there is no one to employ such tactics mentioned earlier. Because authentically educating doctors does not appear to be the reason for their vocation. This is far from being the responsibility of a pharmaceutical sales representative. Perhaps most frightening is that most drug reps fail to dig deep enough to realize that what they do at times may damage public health.

“What you don’t do can be a destructive force.” --- Eleanor Roosevelt
Dan Abshear
Author’s note: What has been written was based upon information and belief.