by Gwen Olsen
Sensitive to the recent Oraflex fiasco in which Eli Lilly covered up deaths due to liver failure from its NSAID in other countries and clinical trials, the FDA made a swift decision to pull Zomax from the market. My first assignment in the field was to retrieve all of my doctors’ Zomax samples.
It should be noted that only ten percent of adverse reactions are true allergic reactions. These are reactions in which the body mounts an attack against the drug as though it was a foreign invader. When this happens, anaphylactic shock occurs. Most drug reactions are attributable to overdoses or poisonings caused by an interaction between two or more substances (Fried 27).
Close on the heels of that recall, I was required to pick up all of the over-the- counter Tylenol in my territory because of the Chicago Tylenol poisonings. (McNeil Pharmaceutical and McNeil Consumer Products are both Johnson & Johnson companies.) This time, McNeil had voluntarily issued the massive recall. As a result, tamper-resistant packaging became mandatory for all over-the- counter products.
However, that was not to be the end of my recall experience with McNeil. The next product to be recalled would hit much closer to home. It was another NSAID called Suprol (suprofen). This was my first new drug launch. I remember the pride and exuberance I felt at the national launch meeting in which loudspeakers pumped out motivating theme music and medical researchers and marketing managers gave exciting, emotional speeches. I soaked in every word with anticipation and awe. I believed this drug was really going to help people!
During the breaks, scientists and corporate executives chatted amiably with reps while feasting on an elaborate array of snacks and beverages. Sumptuous gourmet meals and nightly entertainment further catered to the already inflated egos of the sales force. Open bars accompanied every event. T-shirts and ball caps emblazoned with the Suprol logo were distributed, along with sports bags that would transport all the rep’s acquired goodies back home.
Pumped full of enthusiasm and focused on the key opinion leaders in my community, I returned to my territory. I bombarded them with studies and marketing materials in an effort to find support for my new drug. Marketing direction was very specific. Doctors in each territory had been profiled prior to the launch, and I was well-informed as to who the Early Adopters and High-Volume Prescribers (HVPs) of NSAIDs were. I was also aware of marketing’s last-ditch effort directive to ask a reluctant prescriber to give me just one new start patient, even if it was his or her most difficult patient that had failed other therapies. The rationale was, if a doctor had success in one of his or her most difficult patients, he or she would be more inclined to write prescriptions for additional patients.
One of my doctors who practiced in a small, coastal town wrote large numbers of anti-inflammatory drugs for his predominantly geriatric population. He was an older doc himself, very nice, but set in his ways. He had been profiled as a Late Adopter/Skeptic. After a lengthy debate about the benefits of my new product, he shared his philosophy with me, which was not to prescribe a new drug until it had been on the market for a full year. This way, he could avoid the initial unknown complications that invariably surfaced with each new product. In other words, he preferred a “better safe than sorry” approach.
Still, I persisted in my enthusiasm and, as I had been instructed, asked for that “most difficult patient.” I didn’t leave until the doctor had committed to try the drug on at least one patient. He did finally commit, or, to use sales jargon, I closed him. I left triumphant…or so I thought.
I continued drumming up support for Suprol and had just gotten it added to my major teaching hospital’s formulary when I got the bad news. An emergency teleconference was called, and the company announced a “Dear Doctor” letter would be sent to all physicians that day addressing “new complications” associated with Suprol, primarily flank pain. Nearly twenty-five percent of the patients affected had required hospitalization. Flank pain is a very serious side effect because it indicates the possibility of kidney damage.
Little did I know at the time, one of the doctors who had reported an adverse event, which eventually resulted in death due to dialysis complications, was in my territory. I was later contacted and instructed by management to have my doctor complete an Adverse Drug Reaction (ADR) report. Much to my surprise, the doctor referenced in my instructions was the Late Adopter/Skeptic, who had promised me his “most difficult patient” against his better judgment. Even more startling would be the discovery that the patient had been his very own mother. Of course, I didn’t find that out until I visited him to do the ADR. (By the way, the ADR was a daunting ream of paperwork that appeared to be designed to discourage busy doctors from reporting.) I will never forget the betrayed look on his face or his terse remark to me that “the company’s marketing strategy had obviously been more thoroughly tested than our drug!” I was devastated and riddled with guilt. I didn’t call on his office again for nearly six months. I didn’t have the nerve!
Suprol was eventually recalled in 1987 after it had first been banned in Europe. I found myself backpedaling in offices, once again embarrassed as I picked up samples. Reps were instructed to take a proactive stance with providers by pointing out the swift, decisive action taken by the company to remove the product once the adverse events surfaced. What reps were not told was that Public Citizen, Ralph Nader’s consumer activist organization, had actually sued the FDA in order to protect consumers and have Suprol pulled from the market.
So, I was somewhat surprised later on to discover that not all of my pharmaceutical cohorts in the marketing and sales departments subscribed to the Hippo- cratic Oath: “First, do no harm.” Marketing strategies were designed to do one thing: maximize profits. If information could have a negative impact on the bottom line, reps were instructed to downplay it. The opposite was true of even the most ridiculous perceived benefit. Patent extensions were sought for minute enhancements, and tons of marketing hoopla would tout the “new and improved” products.
A good example would be the relaunch of Prozac under the new name of Sarafem. The drugs are exactly the same chemical, but, because the patent on Prozac was about to expire, it allowed Eli Lilly to capture a market where its new product was exclusively protected by patent. A new disease state emerged that was essentially created for marketing purposes, premenstrual dysphoric disorder (PMDD). Before the Sarafem launch, PMDD did not exist in any diagnostic textbooks.
Prescription for Sales Success
I wouldn’t want to misrepresent the entire pharmaceutical profession. Many of the closest friendships I formed over the years were with colleagues in this industry. They were intelligent, hard-working, dedicated citizens who wanted to do something that made a contribution while providing an above-average income for their families. At one time, I believed, as do most pharmaceutical reps, what I was doing helped people. Like many of them, I wanted to be as informed and well-educated as possible in my profession. I spent numerous hours studying and reading, and I subscribed to several prestigious journals to stay abreast of current literature. However, this was later in my career when my audience of specialistswas a little more challenging than the average family practitioner. The specialists were well-read doctors, and they asked lots of critically intelligent questions. So, in anticipation of their objections, I asked lots of questions and attempted to have a better grasp of my customers’ needs.
I recall an early encounter with a young, marketing executive in the now- defunct Syntex Laboratories. We were at a company-wide sales meeting. Nearly 1,000 reps from around the country were in attendance. He was discussing the dosing recommendations for an NSAID that was a counterpart to the then number one seller for arthritis, Naprosyn (naproxen). The drug’s name was Anaprox DS (naproxen sodium). It is currently sold over-the-counter in less than half the prescription strength as Aleve.
Anaprox is the same chemical compound as Naprosyn. The only difference is the sodium added to improve absorption time. Therefore, Anaprox is promoted for acute, short-term pain. The
drug has a twelve-hour half-life. That means it takes at least twelve hours following administration for the body to eliminate fifty percent of the drug. After that, blood levels of the drug fall below their therapeutic range. A drug with a twelve-hour half-life would require a b.i.d., or twice daily, dosing regimen in order to sustain blood levels and maximize therapeutic efficacy. The Anaprox dosage recommendation, however, was t.i.d., or three times daily. This prompted me to ask the product manager, “Why?”
Initially, he disregarded my question and responded, “Because we can. We sell more pills that way.” He then moved on; however, I persisted and raised my hand again. To his annoyance, I asked, “Doesn’t that unnecessarily increase the possibility of GI [gastrointestinal] complications such as bleeding and ulceration?” His next remark would haunt me for the remainder of my career, “Well, of course it does,” he said chuckling, “but, luckily for those patients, we have a new H2- blocker in the pipeline!” The crowd erupted in laughter, and I made a mental note to ask one of my older colleagues what exactly an H2-blocker was.
During the next coffee break, I discovered H2-blockers (H2-antagonists) were designed to treat stomach ulcerations. The company, indeed, had one in licensing negotiations. Whether this statement was jocular in nature or not, it revealed an underlying attitude that was pervasive in the industry and would surface time and again in my experience. Patients were regarded as consumers and, as such, were a dispensable human commodity.
Ironically enough, I would be the victim of my own wares with this product. Because of my indiscriminate use of Anaprox samples for headaches and back pain, I had a serious GI bleed in 1990. Included in the irony was the fact it hap pened to me during a training program while I was at the Syntex corporate offices in Palo Alto. I realize now it was real-life training for me.
During my research for this book, I discovered more than 16,000 patients die annually from the use of prescription and over-the-counter NSAIDs. I also learned more than 100,000 hospital admissions yearly could be attributed to GI bleeding from NSAIDs alone (Strand 173). Although I knew about the risk of GI bleeding and ulceration, the gravity of these statistics was never brought to my attention by any of the companies for which I sold NSAIDs.
A Loss of Innocence: Ida Smith’s Story
At the beginning of my career, I was a field rep in Corpus Christi, Texas. I sold a variety of medications, including Haldol (haloperidol) for schizophrenia and senile dementia. My territory, with the exception of Corpus Christi, was primarily rural. It included several small towns in the outlying countryside. The demographics of the area were largely Hispanics and the elderly who came south for the winter months.
It was the end of the third quarter, and I was behind in my sales quota for Haldol. That meant forfeiting a significant amount of money from the bonus pool if I didn’t make quota. My territory was at somewhat of a disadvantage because I didn’t have the large number of psychiatrists the reps in other metropolitan areas such as Dallas, Houston, and Austin had. It occurred to me that the most common drawback/objection I received from the general practitioners I called on with this product was patient compliance. (Patients would frequently discontinue the medication because of its side effects.) So, I determined the best way to build my Haldol business would be to campaign for the institutionalized patient. These patients were not only encouraged to take the medication; they were actually given the drug. This completely eliminated the compliance issue.
I set about scheduling training in-services in the local nursing homes and mental health and mental retardation (MHMR) facilities. I increased my call frequency on physicians whom I knew to have nursing home relationships and directorship responsibilities. I littered these offices and institutions with every type of marketing tool known to man. You could not look anywhere in my territory that there wasn’t a clock, coffee mug, calendar, candy dish, scratch pad, or pen displaying the Haldol name.
During my so-called “Haldol Blitz,” I made weekly visits to my nursing homes. The nursing staff was very supportive and appreciated being the recipients of all the goodies and attention that was rarely placed on them. (Reps notoriously do not like to call on nursing homes or abortion clinics.) They began to eagerly recommend to doctors that patients be placed on Haldol and actually kept track of patients who were put on the drug to report to me on subsequent visits. I rewarded these facilities and staffs with catered-in lunches and gift certificates to local restaurants.
In my routine visits to one particular nursing home, I met Mrs. Ida Smith. (I have changed her name to protect her privacy.) Mrs. Smith was a petite, fragile- looking woman in her late eighties. Her snow-white hair was always neatly coiffed. She also wore a bright red lipstick that contrasted starkly with her delicate, pale complexion. Ida was a whirlwind of activity in her motorized wheelchair. She was frequently seen motoring from room to room, checking on and visiting with other residents. It was apparent the nursing staff was put out with Mrs. Smith’s meddling. Ida often complained to staff about patients who were not properly being cared for. She was the self-appointed hall monitor and was not afraid to let people know she was watching. I got a kick out of observing the nurses’ reactions when Mrs. Smith would demand someone change a bedpan or IV bag that had been left unattended. She could definitely hold her own in a debate.
Mrs. Smith became a bright spot in my visits to an otherwise gloomy, depressing facility that reeked with the stench of urine and disinfectant. However, I called on the home one day, and Mrs. Smith was nowhere to be seen. Before departing, I questioned the head nurse about her. “Oh, Mrs. Smith, she’s had a bad patch lately,” she said. “Her friend in 17B died, and it really upset her. She hadn’t been sleeping well and seemed a little disoriented, so we recommended her doctor put her on Haldol. She’s doing a lot better now…sleeping through the night.not combative and quarrelsome like she used to be.” She concluded, smiling. (It was obvious she thought she was making brownie points with me.)
As I rounded the corner to the front door, I saw an attendant pushing Mrs. Smith in her wheelchair into her room. Her head was hung, and she was drooling on her pretty, pink gown. Mrs. Smith looked like a zombie. She was in complete disarray. Her hair was uncombed, and her signature red lipstick was missing. I felt a pang in the pit of my stomach. Had I been responsible for this turn of events? Surely, Mrs. Smith was not the patient-type for whom I had promoted Haldol. Or was she?
I exceeded my quota in all four of my products that sales quarter. Shortly thereafter, I was promoted to a hospital rep’s position in Houston for the Baylor College of Medicine. I would never see Mrs. Smith again. However, my last memory of her would stay fresh in my mind and on my conscience for many years to come.
Selling Out for Sales
For the majority of my career, I sold what I considered, at the time, to be fairly innocuous drugs, even though, as I said previously, I sold several NSAIDs, which are known to kill thousands of people annually and hospitalize tens of thousands more. Over the course of the years, my knowledge base would expand with each new category of drug I sold as I learned about the disease states and the body systems affected by each drug. The flip side of this was that, if I hadn’t sold a particular drug or competed with that category with one of my products, I was as ignorant as the next guy about what it did, how it worked, what risks were associated with its use, and so forth.
One of the advantages I enjoyed while working with a number of key manufacturers was having exceptional training programs. Had I stayed with one company, I would not have had the diversity of product knowledge and variety of sales training I ultimately received. Looking back, I would realize the buyouts, downsizings, layoffs, and ultimate challenges that had forced me to change employment several times had given me a phenomenal array of medical education. In the span of fifteen years, I had promoted NSAIDs, narcotic analgesics, antibiotics, asthma drugs, muscle relaxants, antihypertensive agents, lipid-lower- ing statins, antifungal preparations, birth control pills, diabetes drugs, ho
rmone replacement therapy, stroke treatments, and, of course, neuroleptic drugs. I had worked my way up the corporate ladder, starting with my first promotion from a territory rep to a hospital rep after only eighteen months with McNeil. Then, with Syntex, I was promoted to an ob-gyn specialist. Before being severed, I worked as a cardiology and neurology specialist. I was hired as a cardiology and diabetes specialist with Bristol-Myers Squibb. In nine months, I received the Pinnacle Award, which was given to the top three percent of its sales force. At the end of my career, as an independent contractor, I became an overdressed sample delivery girl. Basically, I was paid per signature. Well, actually, I was paid per call, but I needed to get a doctor’s signature in order to prove I had been there.
Out of all of the drugs I had sold over the years in various specialties, the only drug that ever really challenged my moral ethics was Haldol, particularly Haldol decanoate. This was the “Big Daddy” of all neuroleptics. It made me cringe while learning about this newest form of Haldol during the launch meeting when I envisioned the possible torture in store for some patients. As I indicated earlier, patient non-compliance was a fairly common drawback with Haldol treatment. The side effects of neuroleptic drugs can be absolutely unbearable.
As a hospital rep, I would frequently see institutionalized patients pacing frantically back and forth in waiting rooms, hallways, and outside in foyers. Some would literally wear the soles off of their house shoes. Others would fall sound asleep prostrate on the ground, wherever they were when the drug’s sedative effects hit. Patients frequently drooled, sat staring into space, experienced facial grimacing, or continually made pill-rolling motions between their thumbs and forefingers. I soon realized many of the bizarre behaviors and movements I had previously identified with schizophrenia and other mental illness were entirely the fault of the medications the patients were taking. They were not a manifestation of these disorders.
