It was a Saturday night when I called my parents, both of whom are doctors, to report the intermittent epigastric pain I’d had throughout the day. Since starting medical school a few months earlier, I had a penchant for self-diagnosing ailments that just happened to coincide with the topic of the week. I thus felt certain it was stomach cancer. Yet I was still surprised when my parents said they’d stop by—an offer they never made when I thought I had Ehlers-Danlos or Marfan syndrome.

A quick physical exam left them debating whether I had a peptic ulcer (Mom) or cholecystitis (Dad). I sided with my mom, having just learned that my description fit only 2 of the “4 Fs” and not yet knowing anything about ulcers. When I noted that an ultrasound would have to wait until after an exam early next week, Dad handed me a pint of Haagen-Dazs from the freezer. I happily indulged while he explained that the ice cream would either soothe my ulcerated stomach lining or further aggravate my gallbladder. A half-pint (and a half-hour) later, my parents headed home.

I awoke at 5:30 am with a horrendous pain in the right upper quadrant. I called home and managed to communicate that I was headed to the emergency department, where I underwent the very imaging studies I’d hoped to avoid. After a normal ultrasound, an unremarkable computed tomography (CT), and a good bit of Dilaudid, I was admitted for observation.

On Monday, I was sent for a hepatobiliary iminodiacetic acid (HIDA) scan. A few hours later I felt the same excruciating pain that had brought me to the hospital, and was told that my ejection fraction was 23%. On Tuesday, I was in the operating room having my inflamed and sludge-filled gall bladder excised.

One lesson to take away from this anecdote is that it may be worth exploring low-cost, low-tech means of investigating illness. Although Dad’s affectionately named “Haagen-Dazs test” did not yield a definitive diagnosis, it certainly helped to narrow the differential. In view of the increasing pressure on physicians to curb health care costs and respond to patient complaints about depersonalized treatment, low-tech, low-cost measures are a win for everyone. After all, what patient wouldn’t love being told to eat dessert first?

Karen L. Rolston
Buffalo, NY

It was a Saturday night when I called my parents, both of whom are doctors, to report the intermittent epigastric pain I’d had throughout the day. Since starting medical school a few months earlier, I had a penchant for self-diagnosing ailments that just happened to coincide with the topic of the week. I thus felt certain it was stomach cancer. Yet I was still surprised when my parents said they’d stop by—an offer they never made when I thought I had Ehlers-Danlos or Marfan syndrome.

A quick physical exam left them debating whether I had a peptic ulcer (Mom) or cholecystitis (Dad). I sided with my mom, having just learned that my description fit only 2 of the “4 Fs” and not yet knowing anything about ulcers. When I noted that an ultrasound would have to wait until after an exam early next week, Dad handed me a pint of Haagen-Dazs from the freezer. I happily indulged while he explained that the ice cream would either soothe my ulcerated stomach lining or further aggravate my gallbladder. A half-pint (and a half-hour) later, my parents headed home.

I awoke at 5:30 am with a horrendous pain in the right upper quadrant. I called home and managed to communicate that I was headed to the emergency department, where I underwent the very imaging studies I’d hoped to avoid. After a normal ultrasound, an unremarkable computed tomography (CT), and a good bit of Dilaudid, I was admitted for observation.

On Monday, I was sent for a hepatobiliary iminodiacetic acid (HIDA) scan. A few hours later I felt the same excruciating pain that had brought me to the hospital, and was told that my ejection fraction was 23%. On Tuesday, I was in the operating room having my inflamed and sludge-filled gall bladder excised.

One lesson to take away from this anecdote is that it may be worth exploring low-cost, low-tech means of investigating illness. Although Dad’s affectionately named “Haagen-Dazs test” did not yield a definitive diagnosis, it certainly helped to narrow the differential. In view of the increasing pressure on physicians to curb health care costs and respond to patient complaints about depersonalized treatment, low-tech, low-cost measures are a win for everyone. After all, what patient wouldn’t love being told to eat dessert first?

Karen L. Rolston
Buffalo, NY

It was a Saturday night when I called my parents, both of whom are doctors, to report the intermittent epigastric pain I’d had throughout the day. Since starting medical school a few months earlier, I had a penchant for self-diagnosing ailments that just happened to coincide with the topic of the week. I thus felt certain it was stomach cancer. Yet I was still surprised when my parents said they’d stop by—an offer they never made when I thought I had Ehlers-Danlos or Marfan syndrome.

A quick physical exam left them debating whether I had a peptic ulcer (Mom) or cholecystitis (Dad). I sided with my mom, having just learned that my description fit only 2 of the “4 Fs” and not yet knowing anything about ulcers. When I noted that an ultrasound would have to wait until after an exam early next week, Dad handed me a pint of Haagen-Dazs from the freezer. I happily indulged while he explained that the ice cream would either soothe my ulcerated stomach lining or further aggravate my gallbladder. A half-pint (and a half-hour) later, my parents headed home.

I awoke at 5:30 am with a horrendous pain in the right upper quadrant. I called home and managed to communicate that I was headed to the emergency department, where I underwent the very imaging studies I’d hoped to avoid. After a normal ultrasound, an unremarkable computed tomography (CT), and a good bit of Dilaudid, I was admitted for observation.

On Monday, I was sent for a hepatobiliary iminodiacetic acid (HIDA) scan. A few hours later I felt the same excruciating pain that had brought me to the hospital, and was told that my ejection fraction was 23%. On Tuesday, I was in the operating room having my inflamed and sludge-filled gall bladder excised.

One lesson to take away from this anecdote is that it may be worth exploring low-cost, low-tech means of investigating illness. Although Dad’s affectionately named “Haagen-Dazs test” did not yield a definitive diagnosis, it certainly helped to narrow the differential. In view of the increasing pressure on physicians to curb health care costs and respond to patient complaints about depersonalized treatment, low-tech, low-cost measures are a win for everyone. After all, what patient wouldn’t love being told to eat dessert first?

Karen L. Rolston
Buffalo, NY

I read Dr. Susman’s editorial on PSA screening (J Fam Pract. 2011;60:319) with great personal interest.

I am 43 years old; I have no family history of prostate cancer and had no symptoms. Yet my Gleason 7 prostate cancer was found by a PSA test. You can argue that statistically, it would be better that I be allowed to die so that 722 others could be spared the stress of testing, some subset of those could be spared a biopsy, and some still smaller subset could be spared overtreatment. But my PSA test wasn’t “screening nonsense,” as Dr. Susman laments. It was ordered by a wise and caring physician and it saved my life.

Go ahead and take a position based on statistics. But please don’t dismiss the judgment of other knowledgeable professionals as “nonsense.”

Scott Orwig
Saline, MI

I read Dr. Susman’s editorial on PSA screening (J Fam Pract. 2011;60:319) with great personal interest.

I am 43 years old; I have no family history of prostate cancer and had no symptoms. Yet my Gleason 7 prostate cancer was found by a PSA test. You can argue that statistically, it would be better that I be allowed to die so that 722 others could be spared the stress of testing, some subset of those could be spared a biopsy, and some still smaller subset could be spared overtreatment. But my PSA test wasn’t “screening nonsense,” as Dr. Susman laments. It was ordered by a wise and caring physician and it saved my life.

Go ahead and take a position based on statistics. But please don’t dismiss the judgment of other knowledgeable professionals as “nonsense.”

Scott Orwig
Saline, MI

I read Dr. Susman’s editorial on PSA screening (J Fam Pract. 2011;60:319) with great personal interest.

I am 43 years old; I have no family history of prostate cancer and had no symptoms. Yet my Gleason 7 prostate cancer was found by a PSA test. You can argue that statistically, it would be better that I be allowed to die so that 722 others could be spared the stress of testing, some subset of those could be spared a biopsy, and some still smaller subset could be spared overtreatment. But my PSA test wasn’t “screening nonsense,” as Dr. Susman laments. It was ordered by a wise and caring physician and it saved my life.

Go ahead and take a position based on statistics. But please don’t dismiss the judgment of other knowledgeable professionals as “nonsense.”

Scott Orwig
Saline, MI

Evidence summary

Lumbar disc disease is the most common cause of sciatica.¹ In the absence of red flags, the initial approach to treatment is conservative and includes physical therapy and analgesic medications. In 90% of patients, acute attacks of sciatica improve within 4 to 6 weeks without surgical intervention.^1,2

Experts agree that cauda equina syndrome is an absolute indication for urgent surgical intervention.³ Most also would consider surgery for patients with progressive or severe neuromotor deficit, although no controlled studies exist to support this recommendation.³ If surgery is necessary, discectomy to relieve nerve compression is the current standard of care.³

Surgery provides relief, at least in the short term
A Cochrane review of 4 RCTs compared open and microdiscectomy with nonoperative management of lumbar disc disease in patients with sciatica.¹ All the studies showed a tendency toward improved early outcomes with surgery. However, the results of the studies were limited by lack of adherence to treatment, with high crossover rates from conservative treatment to surgical intervention.

Microdiscectomy produced comparable results to standard open discectomy. The reviewers concluded that, for patients with sciatica caused by lumbar disc prolapse, surgery provides faster relief from the acute attack than conservative management; long-term differences in outcome are unclear.¹

A more recent systematic review of 5 studies that compared surgery with conservative management of sciatica concluded that early surgery provides better short-term relief of sciatica but no benefit after 1 or 2 years.⁴

Despite faster recovery with surgery, questions remain
A subsequent study randomized 283 patients with severe sciatica for 6 to 12 weeks to early surgery or prolonged conservative treatment with surgery if needed.⁵ Primary outcomes were functional disability, intensity of leg pain, and the patient’s self-perceived recovery. Of patients in the early surgery group, 89% (125/141) underwent microdiscectomy after a mean of 2.2 weeks.

At 1 year, intention-to-treat analysis showed no significant difference in disability, pain, or perceived recovery between the 2 groups. However, patients who underwent early surgery reported faster relief of leg pain and a faster rate of perceived recovery. The median time to perceived recovery was 4 weeks (95% confidence interval [CI], 3.7-4.4) for early surgery and 12.1 weeks (95% CI, 9.5-14.9) for prolonged conservative treatment. Both groups had a 95% recovery rate at 52 weeks.

Thirty-nine percent (55/142) of patients randomized to conservative management underwent surgery after a mean of 18.7 weeks, and this lack of adherence to intention to treat may limit the validity of the results. A follow-up study at 2 years continued to show no difference in outcomes between surgery and conservative treatment.⁶

Recommendations

The Institute for Clinical Systems Improvement (ICSI) recommends conservative management initially for acute low back pain with sciatica/radiculopathy because the condition usually improves in 4 to 6 weeks. Surgery is indicated in the following cases:

• cauda equina syndrome
• progressive or significant neuromotor deficit
• neuromotor deficit that persists after 4 to 6 weeks of conservative treatment
• chronic sciatica with positive straight leg raise longer than 6 weeks or uncontrolled pain.

The ICSI recommends that patients being considered for nonemergent surgery have an epidural steroid injection, which may allow them to advance in a nonoperative treatment program.²

The American College of Physicians guidelines agree that most patients with lumbar disc herniation will improve within the first month with conservative management. They recommend discectomy or epidural steroid injections as potential treatment options for patients whose symptoms persist despite conservative therapy.⁷

Evidence summary

Lumbar disc disease is the most common cause of sciatica.¹ In the absence of red flags, the initial approach to treatment is conservative and includes physical therapy and analgesic medications. In 90% of patients, acute attacks of sciatica improve within 4 to 6 weeks without surgical intervention.^1,2

Experts agree that cauda equina syndrome is an absolute indication for urgent surgical intervention.³ Most also would consider surgery for patients with progressive or severe neuromotor deficit, although no controlled studies exist to support this recommendation.³ If surgery is necessary, discectomy to relieve nerve compression is the current standard of care.³

Surgery provides relief, at least in the short term
A Cochrane review of 4 RCTs compared open and microdiscectomy with nonoperative management of lumbar disc disease in patients with sciatica.¹ All the studies showed a tendency toward improved early outcomes with surgery. However, the results of the studies were limited by lack of adherence to treatment, with high crossover rates from conservative treatment to surgical intervention.

Microdiscectomy produced comparable results to standard open discectomy. The reviewers concluded that, for patients with sciatica caused by lumbar disc prolapse, surgery provides faster relief from the acute attack than conservative management; long-term differences in outcome are unclear.¹

A more recent systematic review of 5 studies that compared surgery with conservative management of sciatica concluded that early surgery provides better short-term relief of sciatica but no benefit after 1 or 2 years.⁴

Despite faster recovery with surgery, questions remain
A subsequent study randomized 283 patients with severe sciatica for 6 to 12 weeks to early surgery or prolonged conservative treatment with surgery if needed.⁵ Primary outcomes were functional disability, intensity of leg pain, and the patient’s self-perceived recovery. Of patients in the early surgery group, 89% (125/141) underwent microdiscectomy after a mean of 2.2 weeks.

At 1 year, intention-to-treat analysis showed no significant difference in disability, pain, or perceived recovery between the 2 groups. However, patients who underwent early surgery reported faster relief of leg pain and a faster rate of perceived recovery. The median time to perceived recovery was 4 weeks (95% confidence interval [CI], 3.7-4.4) for early surgery and 12.1 weeks (95% CI, 9.5-14.9) for prolonged conservative treatment. Both groups had a 95% recovery rate at 52 weeks.

Thirty-nine percent (55/142) of patients randomized to conservative management underwent surgery after a mean of 18.7 weeks, and this lack of adherence to intention to treat may limit the validity of the results. A follow-up study at 2 years continued to show no difference in outcomes between surgery and conservative treatment.⁶

Recommendations

The Institute for Clinical Systems Improvement (ICSI) recommends conservative management initially for acute low back pain with sciatica/radiculopathy because the condition usually improves in 4 to 6 weeks. Surgery is indicated in the following cases:

• cauda equina syndrome
• progressive or significant neuromotor deficit
• neuromotor deficit that persists after 4 to 6 weeks of conservative treatment
• chronic sciatica with positive straight leg raise longer than 6 weeks or uncontrolled pain.

The ICSI recommends that patients being considered for nonemergent surgery have an epidural steroid injection, which may allow them to advance in a nonoperative treatment program.²

The American College of Physicians guidelines agree that most patients with lumbar disc herniation will improve within the first month with conservative management. They recommend discectomy or epidural steroid injections as potential treatment options for patients whose symptoms persist despite conservative therapy.⁷

Evidence summary

Lumbar disc disease is the most common cause of sciatica.¹ In the absence of red flags, the initial approach to treatment is conservative and includes physical therapy and analgesic medications. In 90% of patients, acute attacks of sciatica improve within 4 to 6 weeks without surgical intervention.^1,2

Experts agree that cauda equina syndrome is an absolute indication for urgent surgical intervention.³ Most also would consider surgery for patients with progressive or severe neuromotor deficit, although no controlled studies exist to support this recommendation.³ If surgery is necessary, discectomy to relieve nerve compression is the current standard of care.³

Surgery provides relief, at least in the short term
A Cochrane review of 4 RCTs compared open and microdiscectomy with nonoperative management of lumbar disc disease in patients with sciatica.¹ All the studies showed a tendency toward improved early outcomes with surgery. However, the results of the studies were limited by lack of adherence to treatment, with high crossover rates from conservative treatment to surgical intervention.

Microdiscectomy produced comparable results to standard open discectomy. The reviewers concluded that, for patients with sciatica caused by lumbar disc prolapse, surgery provides faster relief from the acute attack than conservative management; long-term differences in outcome are unclear.¹

A more recent systematic review of 5 studies that compared surgery with conservative management of sciatica concluded that early surgery provides better short-term relief of sciatica but no benefit after 1 or 2 years.⁴

Despite faster recovery with surgery, questions remain
A subsequent study randomized 283 patients with severe sciatica for 6 to 12 weeks to early surgery or prolonged conservative treatment with surgery if needed.⁵ Primary outcomes were functional disability, intensity of leg pain, and the patient’s self-perceived recovery. Of patients in the early surgery group, 89% (125/141) underwent microdiscectomy after a mean of 2.2 weeks.

At 1 year, intention-to-treat analysis showed no significant difference in disability, pain, or perceived recovery between the 2 groups. However, patients who underwent early surgery reported faster relief of leg pain and a faster rate of perceived recovery. The median time to perceived recovery was 4 weeks (95% confidence interval [CI], 3.7-4.4) for early surgery and 12.1 weeks (95% CI, 9.5-14.9) for prolonged conservative treatment. Both groups had a 95% recovery rate at 52 weeks.

Thirty-nine percent (55/142) of patients randomized to conservative management underwent surgery after a mean of 18.7 weeks, and this lack of adherence to intention to treat may limit the validity of the results. A follow-up study at 2 years continued to show no difference in outcomes between surgery and conservative treatment.⁶

Recommendations

The Institute for Clinical Systems Improvement (ICSI) recommends conservative management initially for acute low back pain with sciatica/radiculopathy because the condition usually improves in 4 to 6 weeks. Surgery is indicated in the following cases:

• cauda equina syndrome
• progressive or significant neuromotor deficit
• neuromotor deficit that persists after 4 to 6 weeks of conservative treatment
• chronic sciatica with positive straight leg raise longer than 6 weeks or uncontrolled pain.

The ICSI recommends that patients being considered for nonemergent surgery have an epidural steroid injection, which may allow them to advance in a nonoperative treatment program.²

The American College of Physicians guidelines agree that most patients with lumbar disc herniation will improve within the first month with conservative management. They recommend discectomy or epidural steroid injections as potential treatment options for patients whose symptoms persist despite conservative therapy.⁷

A 2004 national survey of more than 3100 American physicians in 6 specialties reported that 94% had some type of relationship with the pharmaceutical industry, mostly involving the receipt of food in the workplace (83%) or free drug samples (78%).¹ Family physicians met with industry representatives more frequently, on average 16 times per month, than other specialties.¹ But at what expense?

Physician interaction with the pharmaceutical industry and acceptance of drug samples has been shown to increase prescription costs and nonevidence-based prescribing.^2-4 Furthermore, evidence suggests that samples are not distributed to the neediest of patients,⁵ and that sampled medicines may be distributed with inadequate labeling, instruction, or discussion of adverse effects.^6,7

Evidence suggests doctors receive little value from detailing visits.^8,9 Physician organizations, including the National Physicians Alliance,¹⁰ No Free Lunch,¹¹ and the American Medical Student Association,¹² have explicit policies refusing gifts from drug companies and encourage members to examine the ethical implications of interactions with drug detailers. However, little guidance or evidence exists concerning the development of individual clinic policies regarding access of pharmaceutical representatives, the use of drug samples, or how such policies might affect prescribing practices of physicians.

Concerned about the operational impact of increased detailer visits on their private practice, the 5 physicians affiliated with Madras Medical Group decided by consensus to discontinue seeing pharmaceutical representatives and accepting and distributing drug samples. At the same time, they instituted scheduled group educational meetings to review nonindustry-supported, objective pharmaceutical resources. They also participated in a qualitative study to gain insight into the impact of this policy change on physician and nurse attitudes toward the practice of pharmaceutical detailing.

Methods

The study team, which included academic researchers unaffiliated with Madras Medical Group, used semistructured interviews with clinicians and key staff members at the rural family practice office. After a detailed literature review, the team created a set of 5 open-ended questions to obtain physician and nurse perceptions in 4 areas:

1. verification of the decision process and policy change banning pharmaceutical representatives and drug samples
2. impact of the policy on patients, physicians, nursing staff, and clinic operations
3. perceived influence of pharmaceutical representatives and drug samples on the practice
4. lessons learned to share with other family medicine practices contemplating implementation of a policy excluding pharmaceutical representatives and drug samples.

On a single day about 2 years after the policy change, an out-of-town neutral interviewer (GA) unaffiliated with the practice interviewed physicians and nurses. The interviewer asked the predetermined questions of each study participant and was free to ask related questions depending on the answers. The team taped the interviews and had them transcribed. Two study investigators and a senior research associate, none of whom were associated with the practice, read each transcript and independently identified common themes, concordance, theme saturation, and unique perspectives. The study was approved by the Oregon Health & Science University Institutional Review Board.

Results

Six clinic personnel participated in the interviews: 3 family physicians with an average of 8 years of practice, and 3 nurses with an average of 20 years of service. (The other 2 practice physicians were not in the office on the day interviews were conducted.) The interviewees agreed that the practice was free of pharmaceutical representatives, sample medicines, and marketing paraphernalia (pens, note pads, etc.). Each interviewee understood and supported the policy.

The analysis of participant responses was organized into 6 themes:

1. patient flow impact
2. detailing influence on prescribing
3. appropriate use and availability of therapeutically important medications
4. relevance of information provided by a pharmaceutical representative
5. value of detailer visits
6. patient and public response.

Patient flow impact
Study participants agreed that not seeing pharmaceutical representatives improved patient flow, and they viewed this lack of interruption from detailers positively.

It’s nice not to have all the interruptions. We have enough interruptions without having to get a signature from a doctor here or try and talk them into spending 5 or 10 minutes with this rep.—(Clinic nurse)

Certainly our work flow is easier. I don’t have my office nurse coming to me saying, “You have to go to talk to this drug rep.” I can go through my day without being interrupted that way. There are already plenty of interruptions. That’s not a necessary one.—(Clinic MD)

Influence on prescribing
All interviewees, particularly the physicians, viewed pharmaceutical detailing as a negative influence on clinical prescribing. This was a major reason for the change in policy. Such influences included receiving information of questionable veracity or objectivity; prescribing sampled medications unnecessarily; choosing sampled drugs because of convenience; and possibly making unethical decisions under the sway of representative gifting.

I think we’d all like to think that the presence of the drug reps doesn’t affect the way we prescribe, but they wouldn’t be here if it didn’t.—(Clinic MD)

Not having the sample cabinet…forces me to prescribe more on cost and efficacy than on what is in the sample cabinet.—(Clinic MD)

Appropriate use and availability of therapeutically important medications
Interviewees noted that sample medications offered by drug detailers were often of questionable benefit.

Samples we had were not necessarily the medicines we’d use first line. If you…start [a person with hypertension] on any medicine that’s in your sample cabinet, you’re not practicing good medicine…what you have is…expensive brand- name medicines that shouldn’t be first line, drive up costs, are not more effective, and possibly [have more adverse effects].—(Clinic MD)

For the most part I don’t see [samples as positively] impacting patients’ care at all. …We had a cupboard full of samples but nothing that was real useful in most cases.—(Clinic nurse)

Some respondents indicated that when they looked in the sample cabinet, the medications there were not what they were looking for. This was a source of frustration. It was also noted that often the samples were not being dispensed to patients but were being used by clinic personnel and their families.

The most valuable elements were samples, so our husbands didn’t have to buy Lipitor.—(Clinic nurse)

A lot of our samples were used by our staff and some of our physicians. I know cholesterol medicines in particular, PPIs, some antidepressants.…—(Clinic MD)

Relevance of information provided by pharmaceutical representative
The physicians viewed the information distributed by pharmaceutical representatives as, at best incomplete, and, at worst, misleading.

The straw that broke the camel’s back around here was Vioxx. We were heavily detailed on Vioxx…and you know, the study that was designed to look at GI side effects—do COX-2 inhibitors have less GI risk than other NSAIDS?—found that it caused heart attacks instead. …We’d been talking about this [policy] before Vioxx, but Vioxx brought it full front.—(Clinic MD)

Staff members, though initially less enthusiastic, grew to understand the policy, embrace the philosophy, and take pride in the clinic’s stance on pharmaceutical detailing.

The philosophy of the physicians led to policy. The philosophy is, “Let’s get our information from sources that don’t have anything to gain from their reports. Let’s try to bring down the cost of drugs.” It’s not necessarily to the patient’s advantage to be given samples of the most expensive drug on the market.—(Clinic nurse)

Value of detailer visits
The study subjects did not see the value of pharmaceutical detailing other than the periodic industry-sponsored lunches. The nurses, in particular, enjoyed this perk and viewed it as important social time for clinic employees to interact outside of the clinical environment. Interviewees further noted that the physicians seldom attended these lunches, as they were busy with other tasks.

Staff liked the lunches. It was a nice treat for them. When we started [the policy change], we provided a once-a-month “pharm-free” lunch…still fun, social interaction…paid out of clinic funds.—(Clinic MD)

Now that we’ve adjusted to it, we’re pretty happy with it. Part of it was once per month someone would bring us lunch. …Rather than educational for us, it was a social gathering. So the doctors now provide a once-a-month employee lunch.—(Clinic nurse)

Although some cost was incurred to replace pens, clock, staplers, and other branded items, the gifts brought by the detailers were not viewed as a big benefit for the clinic or its staff. The ethics of gifting was raised as a conflict of interest.

Patient and public response
To explain the key reasons behind the change in policy to patients and the community, Madras Medical Group sent press releases to local news outlets, and physicians took time to discuss the issues of samples and gifting with their patients.

We submitted a press release to the Madras Pioneer [local weekly newspaper] and Bend Bulletin [regional daily newspaper]. I think patients get this issue a whole lot better than doctors do. Doctors think they’re uninfluenced. They’re wrong. The general public knows and thinks they are. If you look at public surveys and patient surveys, it will very clearly tell you that patients take a dim view of this financial entanglement.—(Clinic MD)

Anecdotal patient feedback to the policy was generally positive. Although the practice conducted no formal survey, physicians and nurses received little negative feedback from patients regarding the policy or the lack of available drug samples. Clinic members believe the policy has resulted in improved patient care and moral clarity.

The feedback I got back from patients was generally very positive…and I got a hand-written thank you note that said, “Way to take a stand.” …It seemed to me that a lot of the people who had the fewest resources and least education were the ones who seemed to understand it the most.—(Clinic MD)

Discussion

This qualitative case study contributes to the discussion about the ethics and potential negative clinical effects of the doctor-pharmaceutical industry relationship.^2,13-20 Leading ethicists have long weighed in on the subject.¹⁵ Medical and nonmedical media outlets are replete with articles outlining the practice of drug detailing and questioning its practice.^21-24

Many academic medical centers have adopted policies regulating the interaction of the pharmaceutical industry with students, residents, and faculty.²⁵ In 2008, the Association of American Medical Colleges’ (AAMC) Task Force on Industry Funding of Medical Education released a report that included “developing principles, recommendations, and guidelines to assist members in refashioning industry relationships to better conform to high standards of medical professionalism.”²⁶ However, of the approximately 800,000 physicians in the United States, only 22% practice full time at academic medical centers that would adopt the AAMC policies.²⁷

While Campbell et al reported that more than 90% of physicians interact with pharmaceutical representatives, little is known about how private practice professionals and office staff perceive this interaction, its impact on office culture and workflow, and strategies or policies for managing this interaction.¹ Our qualitative study provides insight into how a small private primary care practice views working in an environment free from direct pharmaceutical detailing.

The policy change evaluated in this study did not occur overnight. What began as a theoretical and abstract discussion of the potential conflicts of interest in the doctor-pharmaceutical company relationship evolved into a more thorough look at this practice’s habits. Practice staff recorded the number of visits and lunches sponsored by drug companies and were surprised by the high frequency of these contacts. In response, the practice set limits on the number of such lunches and, later, on the number of detailing visits. Some doctors in the practice demanded that, during these visits, only peer-reviewed literature be cited by the representatives. After the rofecoxib (Vioxx) situation hit the press, the practice’s physicians became convinced that these limited interventions were not strong enough and developed the stringent policy change.

Before implementing the policy, the physicians discussed their rationale with the staff. Staff feedback was incorporated into the policy and, to date, there has been no staff turnover either related or unrelated to the policy. Recognizing the need for timely and accurate medication information, the practice began a structured and participatory monthly educational meeting using unbiased, evidence-based materials that were previously available to the doctors but reviewed with varying frequency by different providers.

Pharmaceutical gifts were acknowledged as valuable to the staff (lunches, pens, samples, etc.) and lunches in particular offered important social time. Overcoming the pushback from staff on the elimination of sponsored lunches was remedied by providing a monthly lunch with protected time for staff socialization. Interruptions in the busy clinical day decreased after the policy implementation, thereby improving patient flow. Without the frequent detailing visits, the nurses related that they were better able to focus on their clinical responsibilities. Additionally, the practice’s physicians and nurses observed that sample medications were often taken for personal use. The use of prescription drug samples by clinic staff has been documented elsewhere.²⁸

The practice’s physicians viewed the discontinuation of pharmaceutical representative visits and the elimination of samples through both clinical and ethical eyes. The detailing policy was changed to disentangle physicians from a relationship they believed adversely affected patient care. While gifts given in this practice consisted of lunches and trivial items, the physicians remained concerned about the subconscious impact of these gifts. This sentiment is echoed by research in social sciences documenting the powerful effect on human behavior through the receiving of gifts, even those of little value.²⁹

Other concerns surrounded the veracity and objectivity of the commercial materials. Recent scandals in drug marketing were among the issues that drove these concerns.³⁰ The practice’s physicians wanted prescribing decisions to be based on scientific information obtained from unbiased sources. The policy change resulted in a marked decrease in interaction with drug detailers, but direct mail from pharmaceutical companies continued to arrive. Although the physicians’ report of patient support for the new policy is anecdotal, it is consistent with other research showing that patients are aware of the influence of the pharmaceutical industry on prescribing behavior.³¹

Study limitations. This qualitative study occurred in a single rural family practice with a small number of study participants and may not be universally applicable across all practice locations, sizes, and specialties. Furthermore, qualitative studies in general do not offer rigorous statistical findings seen with other scientific methods.

This exploration does offer some structured insight into the complex relationship between the drug industry and practicing clinicians. Because a significant proportion of physicians practice individually or in small groups, this study may be useful for others who are considering adopting similar policies.

CORRESPONDENCE
David V. Evans, MD, Madras Medical Group, 76 NE 12th St., Madras, OR 97741; [email protected]

A 2004 national survey of more than 3100 American physicians in 6 specialties reported that 94% had some type of relationship with the pharmaceutical industry, mostly involving the receipt of food in the workplace (83%) or free drug samples (78%).¹ Family physicians met with industry representatives more frequently, on average 16 times per month, than other specialties.¹ But at what expense?

Physician interaction with the pharmaceutical industry and acceptance of drug samples has been shown to increase prescription costs and nonevidence-based prescribing.^2-4 Furthermore, evidence suggests that samples are not distributed to the neediest of patients,⁵ and that sampled medicines may be distributed with inadequate labeling, instruction, or discussion of adverse effects.^6,7

Evidence suggests doctors receive little value from detailing visits.^8,9 Physician organizations, including the National Physicians Alliance,¹⁰ No Free Lunch,¹¹ and the American Medical Student Association,¹² have explicit policies refusing gifts from drug companies and encourage members to examine the ethical implications of interactions with drug detailers. However, little guidance or evidence exists concerning the development of individual clinic policies regarding access of pharmaceutical representatives, the use of drug samples, or how such policies might affect prescribing practices of physicians.

Concerned about the operational impact of increased detailer visits on their private practice, the 5 physicians affiliated with Madras Medical Group decided by consensus to discontinue seeing pharmaceutical representatives and accepting and distributing drug samples. At the same time, they instituted scheduled group educational meetings to review nonindustry-supported, objective pharmaceutical resources. They also participated in a qualitative study to gain insight into the impact of this policy change on physician and nurse attitudes toward the practice of pharmaceutical detailing.

Methods

The study team, which included academic researchers unaffiliated with Madras Medical Group, used semistructured interviews with clinicians and key staff members at the rural family practice office. After a detailed literature review, the team created a set of 5 open-ended questions to obtain physician and nurse perceptions in 4 areas:

1. verification of the decision process and policy change banning pharmaceutical representatives and drug samples
2. impact of the policy on patients, physicians, nursing staff, and clinic operations
3. perceived influence of pharmaceutical representatives and drug samples on the practice
4. lessons learned to share with other family medicine practices contemplating implementation of a policy excluding pharmaceutical representatives and drug samples.

On a single day about 2 years after the policy change, an out-of-town neutral interviewer (GA) unaffiliated with the practice interviewed physicians and nurses. The interviewer asked the predetermined questions of each study participant and was free to ask related questions depending on the answers. The team taped the interviews and had them transcribed. Two study investigators and a senior research associate, none of whom were associated with the practice, read each transcript and independently identified common themes, concordance, theme saturation, and unique perspectives. The study was approved by the Oregon Health & Science University Institutional Review Board.

Results

Six clinic personnel participated in the interviews: 3 family physicians with an average of 8 years of practice, and 3 nurses with an average of 20 years of service. (The other 2 practice physicians were not in the office on the day interviews were conducted.) The interviewees agreed that the practice was free of pharmaceutical representatives, sample medicines, and marketing paraphernalia (pens, note pads, etc.). Each interviewee understood and supported the policy.

The analysis of participant responses was organized into 6 themes:

1. patient flow impact
2. detailing influence on prescribing
3. appropriate use and availability of therapeutically important medications
4. relevance of information provided by a pharmaceutical representative
5. value of detailer visits
6. patient and public response.

Patient flow impact
Study participants agreed that not seeing pharmaceutical representatives improved patient flow, and they viewed this lack of interruption from detailers positively.

It’s nice not to have all the interruptions. We have enough interruptions without having to get a signature from a doctor here or try and talk them into spending 5 or 10 minutes with this rep.—(Clinic nurse)

Certainly our work flow is easier. I don’t have my office nurse coming to me saying, “You have to go to talk to this drug rep.” I can go through my day without being interrupted that way. There are already plenty of interruptions. That’s not a necessary one.—(Clinic MD)

Influence on prescribing
All interviewees, particularly the physicians, viewed pharmaceutical detailing as a negative influence on clinical prescribing. This was a major reason for the change in policy. Such influences included receiving information of questionable veracity or objectivity; prescribing sampled medications unnecessarily; choosing sampled drugs because of convenience; and possibly making unethical decisions under the sway of representative gifting.

I think we’d all like to think that the presence of the drug reps doesn’t affect the way we prescribe, but they wouldn’t be here if it didn’t.—(Clinic MD)

Not having the sample cabinet…forces me to prescribe more on cost and efficacy than on what is in the sample cabinet.—(Clinic MD)

Appropriate use and availability of therapeutically important medications
Interviewees noted that sample medications offered by drug detailers were often of questionable benefit.

Samples we had were not necessarily the medicines we’d use first line. If you…start [a person with hypertension] on any medicine that’s in your sample cabinet, you’re not practicing good medicine…what you have is…expensive brand- name medicines that shouldn’t be first line, drive up costs, are not more effective, and possibly [have more adverse effects].—(Clinic MD)

For the most part I don’t see [samples as positively] impacting patients’ care at all. …We had a cupboard full of samples but nothing that was real useful in most cases.—(Clinic nurse)

Some respondents indicated that when they looked in the sample cabinet, the medications there were not what they were looking for. This was a source of frustration. It was also noted that often the samples were not being dispensed to patients but were being used by clinic personnel and their families.

The most valuable elements were samples, so our husbands didn’t have to buy Lipitor.—(Clinic nurse)

A lot of our samples were used by our staff and some of our physicians. I know cholesterol medicines in particular, PPIs, some antidepressants.…—(Clinic MD)

Relevance of information provided by pharmaceutical representative
The physicians viewed the information distributed by pharmaceutical representatives as, at best incomplete, and, at worst, misleading.

The straw that broke the camel’s back around here was Vioxx. We were heavily detailed on Vioxx…and you know, the study that was designed to look at GI side effects—do COX-2 inhibitors have less GI risk than other NSAIDS?—found that it caused heart attacks instead. …We’d been talking about this [policy] before Vioxx, but Vioxx brought it full front.—(Clinic MD)

Staff members, though initially less enthusiastic, grew to understand the policy, embrace the philosophy, and take pride in the clinic’s stance on pharmaceutical detailing.

The philosophy of the physicians led to policy. The philosophy is, “Let’s get our information from sources that don’t have anything to gain from their reports. Let’s try to bring down the cost of drugs.” It’s not necessarily to the patient’s advantage to be given samples of the most expensive drug on the market.—(Clinic nurse)

Value of detailer visits
The study subjects did not see the value of pharmaceutical detailing other than the periodic industry-sponsored lunches. The nurses, in particular, enjoyed this perk and viewed it as important social time for clinic employees to interact outside of the clinical environment. Interviewees further noted that the physicians seldom attended these lunches, as they were busy with other tasks.

Staff liked the lunches. It was a nice treat for them. When we started [the policy change], we provided a once-a-month “pharm-free” lunch…still fun, social interaction…paid out of clinic funds.—(Clinic MD)

Now that we’ve adjusted to it, we’re pretty happy with it. Part of it was once per month someone would bring us lunch. …Rather than educational for us, it was a social gathering. So the doctors now provide a once-a-month employee lunch.—(Clinic nurse)

Although some cost was incurred to replace pens, clock, staplers, and other branded items, the gifts brought by the detailers were not viewed as a big benefit for the clinic or its staff. The ethics of gifting was raised as a conflict of interest.

Patient and public response
To explain the key reasons behind the change in policy to patients and the community, Madras Medical Group sent press releases to local news outlets, and physicians took time to discuss the issues of samples and gifting with their patients.

We submitted a press release to the Madras Pioneer [local weekly newspaper] and Bend Bulletin [regional daily newspaper]. I think patients get this issue a whole lot better than doctors do. Doctors think they’re uninfluenced. They’re wrong. The general public knows and thinks they are. If you look at public surveys and patient surveys, it will very clearly tell you that patients take a dim view of this financial entanglement.—(Clinic MD)

Anecdotal patient feedback to the policy was generally positive. Although the practice conducted no formal survey, physicians and nurses received little negative feedback from patients regarding the policy or the lack of available drug samples. Clinic members believe the policy has resulted in improved patient care and moral clarity.

The feedback I got back from patients was generally very positive…and I got a hand-written thank you note that said, “Way to take a stand.” …It seemed to me that a lot of the people who had the fewest resources and least education were the ones who seemed to understand it the most.—(Clinic MD)

Discussion

This qualitative case study contributes to the discussion about the ethics and potential negative clinical effects of the doctor-pharmaceutical industry relationship.^2,13-20 Leading ethicists have long weighed in on the subject.¹⁵ Medical and nonmedical media outlets are replete with articles outlining the practice of drug detailing and questioning its practice.^21-24

Many academic medical centers have adopted policies regulating the interaction of the pharmaceutical industry with students, residents, and faculty.²⁵ In 2008, the Association of American Medical Colleges’ (AAMC) Task Force on Industry Funding of Medical Education released a report that included “developing principles, recommendations, and guidelines to assist members in refashioning industry relationships to better conform to high standards of medical professionalism.”²⁶ However, of the approximately 800,000 physicians in the United States, only 22% practice full time at academic medical centers that would adopt the AAMC policies.²⁷

While Campbell et al reported that more than 90% of physicians interact with pharmaceutical representatives, little is known about how private practice professionals and office staff perceive this interaction, its impact on office culture and workflow, and strategies or policies for managing this interaction.¹ Our qualitative study provides insight into how a small private primary care practice views working in an environment free from direct pharmaceutical detailing.

The policy change evaluated in this study did not occur overnight. What began as a theoretical and abstract discussion of the potential conflicts of interest in the doctor-pharmaceutical company relationship evolved into a more thorough look at this practice’s habits. Practice staff recorded the number of visits and lunches sponsored by drug companies and were surprised by the high frequency of these contacts. In response, the practice set limits on the number of such lunches and, later, on the number of detailing visits. Some doctors in the practice demanded that, during these visits, only peer-reviewed literature be cited by the representatives. After the rofecoxib (Vioxx) situation hit the press, the practice’s physicians became convinced that these limited interventions were not strong enough and developed the stringent policy change.

Before implementing the policy, the physicians discussed their rationale with the staff. Staff feedback was incorporated into the policy and, to date, there has been no staff turnover either related or unrelated to the policy. Recognizing the need for timely and accurate medication information, the practice began a structured and participatory monthly educational meeting using unbiased, evidence-based materials that were previously available to the doctors but reviewed with varying frequency by different providers.

Pharmaceutical gifts were acknowledged as valuable to the staff (lunches, pens, samples, etc.) and lunches in particular offered important social time. Overcoming the pushback from staff on the elimination of sponsored lunches was remedied by providing a monthly lunch with protected time for staff socialization. Interruptions in the busy clinical day decreased after the policy implementation, thereby improving patient flow. Without the frequent detailing visits, the nurses related that they were better able to focus on their clinical responsibilities. Additionally, the practice’s physicians and nurses observed that sample medications were often taken for personal use. The use of prescription drug samples by clinic staff has been documented elsewhere.²⁸

The practice’s physicians viewed the discontinuation of pharmaceutical representative visits and the elimination of samples through both clinical and ethical eyes. The detailing policy was changed to disentangle physicians from a relationship they believed adversely affected patient care. While gifts given in this practice consisted of lunches and trivial items, the physicians remained concerned about the subconscious impact of these gifts. This sentiment is echoed by research in social sciences documenting the powerful effect on human behavior through the receiving of gifts, even those of little value.²⁹

Other concerns surrounded the veracity and objectivity of the commercial materials. Recent scandals in drug marketing were among the issues that drove these concerns.³⁰ The practice’s physicians wanted prescribing decisions to be based on scientific information obtained from unbiased sources. The policy change resulted in a marked decrease in interaction with drug detailers, but direct mail from pharmaceutical companies continued to arrive. Although the physicians’ report of patient support for the new policy is anecdotal, it is consistent with other research showing that patients are aware of the influence of the pharmaceutical industry on prescribing behavior.³¹

Study limitations. This qualitative study occurred in a single rural family practice with a small number of study participants and may not be universally applicable across all practice locations, sizes, and specialties. Furthermore, qualitative studies in general do not offer rigorous statistical findings seen with other scientific methods.

This exploration does offer some structured insight into the complex relationship between the drug industry and practicing clinicians. Because a significant proportion of physicians practice individually or in small groups, this study may be useful for others who are considering adopting similar policies.

CORRESPONDENCE
David V. Evans, MD, Madras Medical Group, 76 NE 12th St., Madras, OR 97741; [email protected]

A 2004 national survey of more than 3100 American physicians in 6 specialties reported that 94% had some type of relationship with the pharmaceutical industry, mostly involving the receipt of food in the workplace (83%) or free drug samples (78%).¹ Family physicians met with industry representatives more frequently, on average 16 times per month, than other specialties.¹ But at what expense?

Physician interaction with the pharmaceutical industry and acceptance of drug samples has been shown to increase prescription costs and nonevidence-based prescribing.^2-4 Furthermore, evidence suggests that samples are not distributed to the neediest of patients,⁵ and that sampled medicines may be distributed with inadequate labeling, instruction, or discussion of adverse effects.^6,7

Evidence suggests doctors receive little value from detailing visits.^8,9 Physician organizations, including the National Physicians Alliance,¹⁰ No Free Lunch,¹¹ and the American Medical Student Association,¹² have explicit policies refusing gifts from drug companies and encourage members to examine the ethical implications of interactions with drug detailers. However, little guidance or evidence exists concerning the development of individual clinic policies regarding access of pharmaceutical representatives, the use of drug samples, or how such policies might affect prescribing practices of physicians.

Concerned about the operational impact of increased detailer visits on their private practice, the 5 physicians affiliated with Madras Medical Group decided by consensus to discontinue seeing pharmaceutical representatives and accepting and distributing drug samples. At the same time, they instituted scheduled group educational meetings to review nonindustry-supported, objective pharmaceutical resources. They also participated in a qualitative study to gain insight into the impact of this policy change on physician and nurse attitudes toward the practice of pharmaceutical detailing.

Methods

The study team, which included academic researchers unaffiliated with Madras Medical Group, used semistructured interviews with clinicians and key staff members at the rural family practice office. After a detailed literature review, the team created a set of 5 open-ended questions to obtain physician and nurse perceptions in 4 areas:

1. verification of the decision process and policy change banning pharmaceutical representatives and drug samples
2. impact of the policy on patients, physicians, nursing staff, and clinic operations
3. perceived influence of pharmaceutical representatives and drug samples on the practice
4. lessons learned to share with other family medicine practices contemplating implementation of a policy excluding pharmaceutical representatives and drug samples.

On a single day about 2 years after the policy change, an out-of-town neutral interviewer (GA) unaffiliated with the practice interviewed physicians and nurses. The interviewer asked the predetermined questions of each study participant and was free to ask related questions depending on the answers. The team taped the interviews and had them transcribed. Two study investigators and a senior research associate, none of whom were associated with the practice, read each transcript and independently identified common themes, concordance, theme saturation, and unique perspectives. The study was approved by the Oregon Health & Science University Institutional Review Board.

Results

Six clinic personnel participated in the interviews: 3 family physicians with an average of 8 years of practice, and 3 nurses with an average of 20 years of service. (The other 2 practice physicians were not in the office on the day interviews were conducted.) The interviewees agreed that the practice was free of pharmaceutical representatives, sample medicines, and marketing paraphernalia (pens, note pads, etc.). Each interviewee understood and supported the policy.

The analysis of participant responses was organized into 6 themes:

1. patient flow impact
2. detailing influence on prescribing
3. appropriate use and availability of therapeutically important medications
4. relevance of information provided by a pharmaceutical representative
5. value of detailer visits
6. patient and public response.

Patient flow impact
Study participants agreed that not seeing pharmaceutical representatives improved patient flow, and they viewed this lack of interruption from detailers positively.

It’s nice not to have all the interruptions. We have enough interruptions without having to get a signature from a doctor here or try and talk them into spending 5 or 10 minutes with this rep.—(Clinic nurse)

Certainly our work flow is easier. I don’t have my office nurse coming to me saying, “You have to go to talk to this drug rep.” I can go through my day without being interrupted that way. There are already plenty of interruptions. That’s not a necessary one.—(Clinic MD)

Influence on prescribing
All interviewees, particularly the physicians, viewed pharmaceutical detailing as a negative influence on clinical prescribing. This was a major reason for the change in policy. Such influences included receiving information of questionable veracity or objectivity; prescribing sampled medications unnecessarily; choosing sampled drugs because of convenience; and possibly making unethical decisions under the sway of representative gifting.

I think we’d all like to think that the presence of the drug reps doesn’t affect the way we prescribe, but they wouldn’t be here if it didn’t.—(Clinic MD)

Not having the sample cabinet…forces me to prescribe more on cost and efficacy than on what is in the sample cabinet.—(Clinic MD)

Appropriate use and availability of therapeutically important medications
Interviewees noted that sample medications offered by drug detailers were often of questionable benefit.

Samples we had were not necessarily the medicines we’d use first line. If you…start [a person with hypertension] on any medicine that’s in your sample cabinet, you’re not practicing good medicine…what you have is…expensive brand- name medicines that shouldn’t be first line, drive up costs, are not more effective, and possibly [have more adverse effects].—(Clinic MD)

For the most part I don’t see [samples as positively] impacting patients’ care at all. …We had a cupboard full of samples but nothing that was real useful in most cases.—(Clinic nurse)

Some respondents indicated that when they looked in the sample cabinet, the medications there were not what they were looking for. This was a source of frustration. It was also noted that often the samples were not being dispensed to patients but were being used by clinic personnel and their families.

The most valuable elements were samples, so our husbands didn’t have to buy Lipitor.—(Clinic nurse)

A lot of our samples were used by our staff and some of our physicians. I know cholesterol medicines in particular, PPIs, some antidepressants.…—(Clinic MD)

Relevance of information provided by pharmaceutical representative
The physicians viewed the information distributed by pharmaceutical representatives as, at best incomplete, and, at worst, misleading.

The straw that broke the camel’s back around here was Vioxx. We were heavily detailed on Vioxx…and you know, the study that was designed to look at GI side effects—do COX-2 inhibitors have less GI risk than other NSAIDS?—found that it caused heart attacks instead. …We’d been talking about this [policy] before Vioxx, but Vioxx brought it full front.—(Clinic MD)

Staff members, though initially less enthusiastic, grew to understand the policy, embrace the philosophy, and take pride in the clinic’s stance on pharmaceutical detailing.

The philosophy of the physicians led to policy. The philosophy is, “Let’s get our information from sources that don’t have anything to gain from their reports. Let’s try to bring down the cost of drugs.” It’s not necessarily to the patient’s advantage to be given samples of the most expensive drug on the market.—(Clinic nurse)

Value of detailer visits
The study subjects did not see the value of pharmaceutical detailing other than the periodic industry-sponsored lunches. The nurses, in particular, enjoyed this perk and viewed it as important social time for clinic employees to interact outside of the clinical environment. Interviewees further noted that the physicians seldom attended these lunches, as they were busy with other tasks.

Staff liked the lunches. It was a nice treat for them. When we started [the policy change], we provided a once-a-month “pharm-free” lunch…still fun, social interaction…paid out of clinic funds.—(Clinic MD)

Now that we’ve adjusted to it, we’re pretty happy with it. Part of it was once per month someone would bring us lunch. …Rather than educational for us, it was a social gathering. So the doctors now provide a once-a-month employee lunch.—(Clinic nurse)

Although some cost was incurred to replace pens, clock, staplers, and other branded items, the gifts brought by the detailers were not viewed as a big benefit for the clinic or its staff. The ethics of gifting was raised as a conflict of interest.

Patient and public response
To explain the key reasons behind the change in policy to patients and the community, Madras Medical Group sent press releases to local news outlets, and physicians took time to discuss the issues of samples and gifting with their patients.

We submitted a press release to the Madras Pioneer [local weekly newspaper] and Bend Bulletin [regional daily newspaper]. I think patients get this issue a whole lot better than doctors do. Doctors think they’re uninfluenced. They’re wrong. The general public knows and thinks they are. If you look at public surveys and patient surveys, it will very clearly tell you that patients take a dim view of this financial entanglement.—(Clinic MD)

Anecdotal patient feedback to the policy was generally positive. Although the practice conducted no formal survey, physicians and nurses received little negative feedback from patients regarding the policy or the lack of available drug samples. Clinic members believe the policy has resulted in improved patient care and moral clarity.

The feedback I got back from patients was generally very positive…and I got a hand-written thank you note that said, “Way to take a stand.” …It seemed to me that a lot of the people who had the fewest resources and least education were the ones who seemed to understand it the most.—(Clinic MD)

Discussion

This qualitative case study contributes to the discussion about the ethics and potential negative clinical effects of the doctor-pharmaceutical industry relationship.^2,13-20 Leading ethicists have long weighed in on the subject.¹⁵ Medical and nonmedical media outlets are replete with articles outlining the practice of drug detailing and questioning its practice.^21-24

Many academic medical centers have adopted policies regulating the interaction of the pharmaceutical industry with students, residents, and faculty.²⁵ In 2008, the Association of American Medical Colleges’ (AAMC) Task Force on Industry Funding of Medical Education released a report that included “developing principles, recommendations, and guidelines to assist members in refashioning industry relationships to better conform to high standards of medical professionalism.”²⁶ However, of the approximately 800,000 physicians in the United States, only 22% practice full time at academic medical centers that would adopt the AAMC policies.²⁷

While Campbell et al reported that more than 90% of physicians interact with pharmaceutical representatives, little is known about how private practice professionals and office staff perceive this interaction, its impact on office culture and workflow, and strategies or policies for managing this interaction.¹ Our qualitative study provides insight into how a small private primary care practice views working in an environment free from direct pharmaceutical detailing.

The policy change evaluated in this study did not occur overnight. What began as a theoretical and abstract discussion of the potential conflicts of interest in the doctor-pharmaceutical company relationship evolved into a more thorough look at this practice’s habits. Practice staff recorded the number of visits and lunches sponsored by drug companies and were surprised by the high frequency of these contacts. In response, the practice set limits on the number of such lunches and, later, on the number of detailing visits. Some doctors in the practice demanded that, during these visits, only peer-reviewed literature be cited by the representatives. After the rofecoxib (Vioxx) situation hit the press, the practice’s physicians became convinced that these limited interventions were not strong enough and developed the stringent policy change.

Before implementing the policy, the physicians discussed their rationale with the staff. Staff feedback was incorporated into the policy and, to date, there has been no staff turnover either related or unrelated to the policy. Recognizing the need for timely and accurate medication information, the practice began a structured and participatory monthly educational meeting using unbiased, evidence-based materials that were previously available to the doctors but reviewed with varying frequency by different providers.

Pharmaceutical gifts were acknowledged as valuable to the staff (lunches, pens, samples, etc.) and lunches in particular offered important social time. Overcoming the pushback from staff on the elimination of sponsored lunches was remedied by providing a monthly lunch with protected time for staff socialization. Interruptions in the busy clinical day decreased after the policy implementation, thereby improving patient flow. Without the frequent detailing visits, the nurses related that they were better able to focus on their clinical responsibilities. Additionally, the practice’s physicians and nurses observed that sample medications were often taken for personal use. The use of prescription drug samples by clinic staff has been documented elsewhere.²⁸

The practice’s physicians viewed the discontinuation of pharmaceutical representative visits and the elimination of samples through both clinical and ethical eyes. The detailing policy was changed to disentangle physicians from a relationship they believed adversely affected patient care. While gifts given in this practice consisted of lunches and trivial items, the physicians remained concerned about the subconscious impact of these gifts. This sentiment is echoed by research in social sciences documenting the powerful effect on human behavior through the receiving of gifts, even those of little value.²⁹

Other concerns surrounded the veracity and objectivity of the commercial materials. Recent scandals in drug marketing were among the issues that drove these concerns.³⁰ The practice’s physicians wanted prescribing decisions to be based on scientific information obtained from unbiased sources. The policy change resulted in a marked decrease in interaction with drug detailers, but direct mail from pharmaceutical companies continued to arrive. Although the physicians’ report of patient support for the new policy is anecdotal, it is consistent with other research showing that patients are aware of the influence of the pharmaceutical industry on prescribing behavior.³¹

Study limitations. This qualitative study occurred in a single rural family practice with a small number of study participants and may not be universally applicable across all practice locations, sizes, and specialties. Furthermore, qualitative studies in general do not offer rigorous statistical findings seen with other scientific methods.

This exploration does offer some structured insight into the complex relationship between the drug industry and practicing clinicians. Because a significant proportion of physicians practice individually or in small groups, this study may be useful for others who are considering adopting similar policies.

CORRESPONDENCE
David V. Evans, MD, Madras Medical Group, 76 NE 12th St., Madras, OR 97741; [email protected]