The Benefits and Flaws of Pharmaceutical Detailing

The Benefits and Flaws of Pharmaceutical Detailing
May 5, 2022 No Comments Vision of Justice Sophia F. '21

Finding the Line between Profit and Patients: The Ethics of Pharmaceutical Detailing

By Sophia Famular

This paper discusses the ethics of pharmaceutical and academic detailing, touching briefly on direct-to-consumer advertising and its effects. Pharmaceutical detailing is a method that pharmaceutical companies employ to inform physicians about prescription medications. Academic detailing also informs doctors about prescription drugs, but academic detailers are not employed by pharmaceutical companies. Instead, they are employed by outside organizations, typically from the government. I identify stakeholders like patients, physicians, and drug companies and explore their responsibilities. I dive into how detailing impacts patients’ and doctors’ autonomy. I discuss how detailing affects doctors’ ability to uphold their responsibilities to patients. Overall, this paper will discuss and respond to the main ethical question:  Does detailing need to be modified/remain the same and by whom should it be changed?

Table of Contents

Abstract

This paper will discuss the impact of pharmaceutical detailing in the U.S. and whether it should be changed. Pharmaceutical detailing refers to the marketing of drugs directly to physicians and other health care providers.. In this paper, I will explore the varying ethical responsibilities of different stakeholders in the realm of detailing. The primary responsibilities discussed in this paper include the responsibilities of physicians’ to patients, detailers’ to physicians, drug companies’ to physicians, and government’s to physicians and patients. Beyond these responsibilities, the essay will also look at past prescribing trends and how these have correlated with detailing laws and regulations. 

The paper’s main ethical focus will be on analyzing the intentions and responsibilities of different stakeholders, including doctors, drug companies, the government, and the patient, with regard to the practices of pharmaceutical and academic detailing; what they are and what they should be. In this paper, I will consider a doctor’s responsibility to be beneficent to their patient and how that responsibility and the doctor’s autonomy may be challenged by certain aspects of detailing visits or other means of staying informed about drug products. It will consider the presence of economic interest of drug companies and the government and how that may affect/harm the healthcare system. It will also look through a lens of consequentialism to see if these intentions have any impact on prescribing trends. It will also look at how detailing practices may infringe upon patient autonomy, one of the four main principles of bioethics, by giving way to paternalistic laws and guidelines. The paper’s main ethical question, after considering these values and principles is: Should the practice of detailing remain the same, be modified, or end? If so, who holds the most responsibility and authority to make that decision?

Pharmaceutical Detailing

Physicians have a responsibility to uphold the four principles of bioethics when treating their patients. Under the Hippocratic Oath, in which a doctor swears to care for a patient as best as possible, these four principles: autonomy, beneficence, non-maleficence, and justice are implied. The Oath refers specifically to respecting a patient’s “privacy” (autonomy), acting for “the benefit of the sick” (beneficence and non-maleficence), and considering a patient’s “economic stability” (justice) when caring for a patient. Physicians also have the responsibility to apply “ all measures” for the sick (Practo, 2015). This would mean using all of their knowledge of medicine to aid a patient, which could be by informing patients of new or existing drugs that may be beneficial to them. 

I will apply, for the benefit of the sick, all measures [that] are required…I will respect the privacy of my patients…I will remember that I do not treat a fever chart, a cancerous growth, but a sick human being, whose illness may affect the person’s family and economic stability The Hippocratic Oath: The Original and Revised Version -Practo

Once they are out of medical school, how do physicians find out about new drugs and then inform their patients? One method is detailing: there are different types of pharmaceutical detailing but they all serve the purpose of directly informing and advising physicians on new drug products. To do this, different detailing services, from pharma companies or government-sponsored counter-detailers, will send a representative to a doctor’s office for a meeting (this has of course changed due to the COVID-19 pandemic and these meetings are now occurring virtually). Pharma companies find detailing effective because healthcare professionals are responsible for applying their scientific knowledge when treating patients, writing patients’ prescriptions, and being informed about the risks/benefits of prescription drugs so drug companies can properly inform/warn them of any and all side effects of a drug and would, thus, be better-suited to be informed of drugs. At this meeting, a presentation for a new available drug product(s) will be made to the doctor. The information given at the presentation is supposed to be consistent with the drug’s FDA-approved label and often includes clinical data. There are two different types of detailing: academic and pharmaceutical. Academic detailing comes from non-pharmaceutical organizations such as the Academic Detailing Service run by the Department of Veterans Affairs in the U.S. government, other health organizations, or university-based organizations. This presentation will not have the same motivations as a drug company trying to sell its product, however it may reflect other goals such as prescription cost containment or other economic interests. 

Image by HeungSoon from Pixabay

Pharmaceutical detailing is undertaken by pharmaceutical companies. The representative may deliver their presentation in a manner that reflects training in selling techniques, as it is a promotional presentation coming directly from a drug company that would like to increase sales of their product. However, the content of the presentation is still subject to FDA regulations, like only presenting a drug’s FDA-approved use, not other off-label uses the drug may have. Detailing from a drug company can also come from a member of staff trained on scientific aspects of products. Companies can engage in what is called “scientific exchange”, which is non-promotional scientific communication and discussion of products. Typically this involves the deployment of scientifically trained staff to speak with healthcare professionals about clinical trial results and other scientific topics in a non-promotional manner that is supposed to be a robust exchange of scientific knowledge and understanding, not a persuasive presentation designed to convince a prescriber to prescribe a product. This engagement is typically held at a doctor’s office. This type of presentation is still subject to the same aforementioned FDA regulations as the presentation given by a sales representative. 

Examples of regulations on pharmaceutical detailing include PhRMA code and the federal anti-kickback statute and False Claims Act, with which pharmaceutical detailing must comply. In states that have made the voluntary PhRMA Code on Healthcare Interactions part of their state legal framework, detailers must also comply with these regulations as well.

The PhRMA Code on Interactions with Healthcare Professionals (HCPs) applies certain restrictions to meetings with healthcare professionals. One restriction is the allowance of “modest meals” during a meeting. A detailer may not pay for an extravagant, expensive meal to try to persuade the physician. A meal is not required at a visit, but if one is provided, it must be “modest,” as defined by PhRMA.  Also, items that are offered to HCPs must not be “of substantial value ($100 or less)” and must “not have a value to the health care professionals outside of their professional responsibilities” (PhRMA). Any items offered at a meeting must have an educational value and must encourage education about available products that promote disease prevention and medical advancement. Sample drug products are offered often. These are different from educational items authorized under the PhRMA Code. The purpose of drug samples, unlike educational items, is to enable a physician to give a patient a medicine to try without requiring the patient to spend money to see if it may work for them. All of these items are offered to help persuade a doctor to listen to a detailer as well as convince them to prescribe their product. The meeting cannot be conducted at any “recreational” events (sports games, movies, etc.). 

these guidelines indicated that gifts to doctors from industry should primarily entail a benefit to patients, and should not be of substantial value (including the value of meals and entertainment). They also recommended that cash reimbursements should not be accepted directly by doctors to underwrite the costs of attending a CME program. In addition, they stated that gifts directly or indirectly connected to prescribing patterns are not to be accepted by doctors under any circumstances. The Medical Industry’s Practice of Giving Gifts to Doctors. How Should the Law and Professional Regulations Address It? -George Kanabe

The anti kickback statute, passed by the US government in 1972, states that it is “a criminal offense”  to offer “any remuneration to induce or reward items or services reimbursable by a Federal health care program” (Kalantar, 2019). An example would be if a company was to pay a doctor more than fair market value to participate in a research project or speak at an event in order to “thank” or “reward” the doctor for prescribing the company’s medicines. Detailing, however, is not the only method of company-to-physician marketing. 

The anti-kickback statute 42 U.S.C. § 1320a-7b(b) states that doctors or representatives of a facility or manufacturer could face criminal penalties for making or inviting “referrals” in exchange for something of value. How Physicians Violate the Anti-Kickback Statute -Art Kalantar

Pharmaceutical manufacturers educate prescribers by promoting to them through detailing, by publishing websites, by publishing print and digital informational materials that discuss the product(s), by conducting in-office and out-of-office educational sessions about the products that may be accompanied by “modest meals,” and by conducting educational sessions at scientific meetings. Note that doctors may also inform themselves about potential prescription drugs through the following means: attending educational sessions in their hospital or medical office, reading articles in medical journals, attending medical society meetings, by reading medical society bulletins, and many others. Detailing is by no means the only way the doctors can find out about new prescription drug products.

Pharmaceutical companies also employ Direct to Consumer, or DTC, advertising for some products. Patients may find out about drug products themselves from commercial advertisements online, on television, etc. These ads are regulated as well, by the FDA. Ads are required to only highlight the FDA-approved uses of the drug, even if it may treat other ailments and they are also required to list the side effects. However, because of the direct contact with physicians, drug companies generally invest more in detailing than to direct consumer marketing (Llamas, 2016).

Further, the US and New Zealand are the only two countries to allow commercial drug ads. DTC television advertising has become popular in the last 20-30 years as drug companies started to recognize it as an effective way to reach customers (Wilkes, 2000).

Bias and Manipulation in Detailing

Because different detailers, coming from companies and the government, have different intentions for a detailing presentation, each presentation will have a bias, but the biases may be different. Detailers, both academic and commercial, follow a model of presentation. This begins with an introduction where the detailer states the reason for visit, their personal background, their organizational affiliation, and how the clinician and their patients may benefit from the treatment under discussion. It also includes a needs assessment.

Detailers use open-ended questions to determine the concerns and beliefs of the clinician to tailor the information to meet their specific needs and gaps in knowledge. Academic Detailing: An Interactive, Nonbiased, Evidence-Based, and Individualized Educational Outreach -Lori Uildriks

This could create bias, even unintentionally, because any “tailoring” of information in the presentation, even supposedly to meet the needs of the doctor, may make the presentation stray from its original, approved form, thus creating bias and manipulated bias. The detailer themself is biased because, in their presentation, they are promoting a product, but the product’s effectiveness is not the main priority, prescriptions are. However, they also want to generate bias in the prescribing physician, so there is also manipulation of the physician. The detailer wants to know the physician’s beliefs to make the presentation more convincing. They still want to recommend the same things but change how they recommend based on the doctor. Then the representative makes their presentation of the drug, which includes efficacy and safety data for the drug. 

Ethical Models in Academic Detailing

An academic detailer from a government program would likely have a more utilitarian view of the healthcare system and their presentation would reflect that. A utilitarian view of the healthcare system values the greater good of the public over an individual patient’s needs with regard to what drugs to prescribe. So, for example, prescribing less expensive drugs over more expensive, drugs would be considered ethical under a utilitarian model because lower prices serve the greater good, although this lens may not factor in a drug’s effectiveness.

For example, Patient X has just had a liver transplant, is in their recovery period, and needs a pain killer. Their physician prescribes a strong opioid and it works well for patient X. However, this same opioid has been over-prescribed in the past and had been known to cause addiction, so the government would like doctors to prescribe other pain-killers instead of this specific type. An academic detailer is consequently sent to a doctor’s office to present about new, less addictive pain killers. The doctor then starts prescribing these to patients. Patient X comes back for another pain killer prescription and is given this one and it does not work well. The government’s actions with the view of the greater good have affected this individual patient X. 

For example, Patient X has just had a liver transplant, is in their recovery period, and needs a pain killer. Their physician prescribes a strong opioid and it works well for patient X. However, this same opioid has been over-prescribed in the past and had been known to cause addiction, so the government would like doctors to prescribe other pain-killers instead of this specific type. An academic detailer is consequently sent to a doctor’s office to present about new, less addictive pain killers. The doctor then starts prescribing these to patients. Patient X comes back for another pain killer prescription and is given this one and it does not work well. The government’s actions with the view of the greater good have affected this individual patient X. 

Academic detailing is also conducted to support the government goal of cost containment, since the federal government pays (through the Medicaid and Medicare programs and other government-funded health care programs) for substantial quantities of prescription drugs. This could result in a scenario like the one above, but with an academic detailer presenting a less expensive drug that does not work well for patient X.

Impacts of Detailing

Looking through a lens of consequentialism, which means judging by the consequences of a practice to determine if it is ethical, what impacts do detailing and commercial marketing — with their aforementioned biases —  actually have on prescription sales and usage? What else causes changes in prescription trends? Generally, when drugs are advertised more frequently (through detailing) more brand-name drugs are prescribed (Rea, 2017). A study conducted by UCLA’s Ian Larkin and CMU’s George Loewenstein showed that increased restrictions applied by Academic Medical Centers to pharmaceutical detailers affected a trend of prescriptions (Rea, 2017). Physicians began to prescribe cheaper, generic drugs over more expensive, patent protected drugs. The restrictions mostly restricted gifts and small meals but did not restrict meetings altogether. This study calls into question the effect of gifts and small meals that may be exchanged during a detailing presentation on physicians. Perhaps they are too effective to the point where a doctor may stray from their responsibility to patients.

However, does this prescription trend actually affect healthcare? Assuming prescription detailing is positively correlated with prescribing brand name drugs and negatively correlated with prescribing generic drugs, would the increase in generic drugs through actively limiting detailing have a positive effect on patient healthcare? This is a highly-debated topic. Generic forms of a drug must have the same active ingredients as a brand-name and must be FDA-approved, so what’s the difference?

Ragesoss, CC BY-SA 4.0 https://creativecommons.org/licenses/by-sa/4.0, via Wikimedia Commons

Patients may have an allergy to one of the inactive ingredients in the generic, however this could also happen with brand-name drugs. They may also have religious or dietary restrictions that make them unable to take the generic. Again, this could happen with a brand-name drug as well. Finally, the generic formulation may not look the same visually as the brand-name and this may make the patient reluctant to take a drug they are not familiar with. Generic drugs can be significantly less expensive, mostly in the US. Companies producing these drugs do not need to spend as much money on marketing, sales, etc. as brand-name companies do and can therefore lower their drug price. Based on this information, does the above case of increased prescription of generic drugs cause a significant problem of diminished quality of healthcare? It would not absolutely cause a diminished quality of healthcare because generic drugs are not absolutely less effective than brand name drugs, or vice versa, however, just the sway that small gifts have on physicians could cause potential for a diminished quality of healthcare.

The Role of Autonomy

What role does autonomy play in detailing practices? Drug companies focus on detailing over consumer marketing because it is more effective from their point of view. It is more effective because HCPs are responsible for prescribing medications and, thus, determining which drugs are prescribed. Primarily marketing drugs to physicians removes part of a patient’s autonomy, that is, their right and ability to be informed about drugs they may be prescribed. Though physicians, by the hippocratic oath, are meant to uphold this right, some may slip through the cracks. How is one meant to make a decision about a drug they do not know about? Even when patients are informed about drugs, whether through commercial ads or otherwise, they may still rely on HCPs to address their specific concerns and circumstances pertaining to a particular drug, but to do so is a choice and should remain one. One can make the decision to rely on their doctor as their primary source of legitimate medical knowledge, but it’s still their decision and they should have the option not to do so. The Learned Intermediary Doctrine (LID) limits the patient’s autonomy by encouraging the mindset that a physician knows best. 

Autonomy by ProSymbols from NounProject.com

The Learned Intermediary Doctrine is a legal construct saying that a pharmaceutical company will not be liable to a patient for failure to adequately warn about the potential risks associated with a product if it has provided an adequate warning to the patient’s prescriber (historically the physician) – the “learned intermediary” between the manufacturer and the patient. The assumption is that the physician has the necessary training to understand the science underlying the medicine, as well as the knowledge of the patient’s medical background and history that enables the physician – as opposed to the patient – to be in the best position to make the judgment about whether the medication may be right for the patient. This does not apply to many non-pharmaceutical companies. Such companies must provide adequate warning about the potential risks of a product (such as a lawnmower) directly to the consumer as there is not a “learned intermediary” in those businesses. In commercial drug ads, warnings of potential risks and side effects are given according to FDA-standards, but this list does not include all of the side effects, as it is not required per the LID. It is merely a form of liability protection for drug companies.

The LID gives way to a paternalistic way of practicing medicine, by taking away a patient’s autonomy by assuming the physician knows what’s best for the patient. This may contradict the Hippocratic Oath because, in a way, this encourages physicians to “play God” by ultimately deciding what to prescribe without the need to inform patients of all information about their prescription. However, the very fact that a physician swears to the Hippocratic Oath could put a limit on the potential paternalistic side to the Learned Intermediary Doctrine because physicians, after swearing not to, would not give in and use it to “play God.” Also, patients still maintain the ability to refuse a prescription after a doctor has prescribed it.

Conclusion and Further Thoughts

Considering the facts and ethical implications, the main ethical question is: Does detailing need to be modified/remain the same and by whom should it be changed?

Perhaps to be more “unbiased,” detailing should be in the form of an article or prerecorded informational video, rather than a person to eliminate tailoring to specific people and instead tailoring to specific doctors. It would be less emotionally-driven, thus more purely informational. Moreover, who should be the one to make that decision of whether to end, change, or keep detailing? The two major players are doctors and the government because both have a responsibility to the people’s health. Drug companies hold this responsibility as well because their job is to advance medicine, and therefore the health of the public, but not with the same direct responsibilities as physicians and the government do. Drug companies may focus more on the scientific advancement part of medicine as opposed to the what is best for the patient. Whereas the government has a greater responsibility to balance patients’ need for a treatment or drug option versus the ability to develop it. Doctors hold the greatest responsibility to the individual patient and how the larger system affects them. Ultimately, when thinking realistically and ethically, the government holds the most responsibility and ability to create more regulations on detailing and advertising practices of pharmaceutical companies.

With this information in mind, how would one navigate effecting tangible changes to the healthcare system and pharmaceutical industry practices? In determining which roles each should play (physicians, the government, and pharma companies), one must combine both ethics and reality. 

Should doctors attend briefings in psychology as to not be affected by the presence or absence of “modest meals” and/or gifts? If physicians were made aware of the implications, would that aspect of a presentation even be necessary or serve any purpose? If this were to happen, how would the loss of “classic detailing,” meaning detailing that includes sales tactics and emotional appeal, affect prescribing trends? How much does American society (capitalistic) play into these practices?

Would eliminating the economic aspect or for-profit interest of drug companies make the health care system more “for patient” as opposed to for-profit? In what ways does detailing complicate the healthcare system and the types of care patients receive? In what ways does detailing benefit patients or harm them? Are we able to reconcile these considerations?

I believe awareness is key, so physicians and HCPs having training where they learned to recognize bias more acutely would alleviate some of the more coercive elements of detailing presentations. The alternative would be for the government to mandate that these more coercive elements be eliminated, but “coercive” is subjective. Therefore, just becoming more aware of potential bias or manipulation would be the best course of action. If more regulations on detailing were to be increased, it would surely have an effect on prescription trends, but this would not be a bad thing as patient’s health, not drug companies’ profit, is the priority. While America’s capitalistic economy makes pharmaceutical companies profit-driven, trying to remove the economic aspect of the industry is unrealistic. Again, just becoming more aware and conscious of the realities of detailing and advertising would lessen their harmful effects.

All of these proposed changes and suggestions have benefits and drawbacks. Because, in reality, dismantling and rebuilding a pharmaceutical industry that is completely ethical from all perspectives is impossible, spreading awareness about these topics and continuing to be skeptical will ultimately lead to progress in the future and a more ethical pharmaceutical industry.

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