Nursing Pharmaceutics: Educating Toward Safer Pharmaceutical Care

Nursing Pharmaceutics: Educating Toward Safer Pharmaceutical Care

When Felicia Menefee, RN, NP, ACNS, recruited patients for the landmark African-American Heart Failure Trial (A-HeFT), little did she know that the study would yield such positive results for them—or future patients.

Since African Americans with advanced left ventricular heart failure do worse than Caucasians in all phases of this condition, scientists wanted to see if adding a potent nitrate-vasodilator-duo to their standard therapy would make a positive difference in their symptoms, hospitalizations, and daily activities. What was the target of this National Institutes of Health study? A fixed-dose combination of isosorbide dinitrate (ISDN) plus hydralazine (HYD).

When researchers discovered that patients on the drugs indeed functioned better clinically than previously (some even energized enough to exercise), they halted the blind study prematurely. In doing so, they also handed the US Food and Drug Administration (FDA) enough data to demonstrate that survival and quality of life indeed increased, while hospitalizations decreased, on the medications. The FDA approved ISDN/HYD in June 2005 for heart failure therapy in blacks.

A-HeFT is just one of a myriad of NIH- and industry-sponsored drug and device trials Menefee has participated in during her 17 years as a nurse practitioner with Kansas City-based St. Luke’s Cardiovascular Consultants. Staffed by 48 cardiologists, many of whom are tied to academia, the practice provides ample opportunity for her to participate in clinical studies.

“Research is extremely important in advancing medicine,” she says. “Without it, health care stagnates. But with drug and other studies we can improve care. Sometimes a trial’s results are negative; sometimes they’re positive. But we won’t know unless we do it.”


Primed for Drug Studies

Perhaps you have the same curiosity as Menefee in advancing new pharmaceuticals or expanding indications for existing ones. What role can you play to help develop the next cutting-edge prescription or the newest use for an over-the-counter standard?

Truth is that unless you’ve piggy backed your nursing experience onto another degree—perhaps pharmacy, biochemistry, or medicine—your contribution likely won’t be in a drug company (or academic center) laboratory. Pharmaceutical scientists involved in the discovery or refinement of new medications typically bring masters and PhDs in the hard sciences to a company’s research and development function.

But that doesn’t mean your experience isn’t valuable. Clinical knowledge, critical thinking skills, and caregiver intuition can be a perfect match for other positions directly impacting medications. In fact, by parlaying and building on your background, you can ensure that what scientists produce in the laboratory is both safe and efficacious in real people. Whether you’re coordinating clinical drug trials in a patient setting, fielding adverse events for a pharmaceutical company, or playing another role, you can find a rewarding frontline niche.

As Sherry Banez-Muth, RN, manager of coordinating services, Center for Clinical Studies, Washington University School of Medicine, St. Louis, observes: “It’s definitely satisfying when you see people taking a new treatment that may be life-changing. It’s a good feeling to say, ‘Wow, I contributed to this.’”


Coordinating for Results

            The good news for nurses and nurse practitioners is that you don’t have to stray far from a patient setting to be part of the drug development process. Once scientists have tested their hypothesis to determine that a preparation developed in the lab may indeed help with a specific indication, the scene shifts to the FDA for a human study protocol approval. When the regulatory agency is on board, sponsors can enlist multiple clinical trial sites—health systems and large medical practices—for the Phase I to IV (and post-marketing) human studies.

Much of the work at those locales rests with nursing professionals, point people in the day-to-day operations of a drug trial. As clinical research or study coordinators, they juggle multiple tasks in making the protocol work. They not only train supporting cast members to find, screen, enroll, monitor, and collect data on participants, but they’re often on board from the onset, helping principal investigators prove that a health provider has what it takes—in experienced staff, adequate space, and access to the right patient demographics—to move a protocol forward.

As a director of clinical research for the Dallas-based Baylor Health Care System, Jennifer Thomas, RN, BSN, MS, CCRC, works side-by-side with investigators, first reviewing potential drug or device trials to ensure that they’re a good fit both financially and clinically for the institution. Thomas had her nursing skills tucked neatly under her belt when she earned a clinical research administration masters to even the negotiating playing field with sponsors over start-up costs and other numbers. “It helped me look at the bigger picture,” she says. “I’m better able to account for everything we need to do to go into a trial.”

Although Thomas no longer conducts individual studies, her imprint is widespread since she provides education and other resources to 40 professionals who manage from 70 to 100 investigational drug, device, and prevention studies, covering a multitude of conditions from diabetes to transplant research. She makes sure others are knowledgeable about a particular study and ready to conduct it according to regulations and good clinical practice.

That means becoming familiar with all aspects of the protocol, a regulatory document that can range from a mere 20 pages to a 500-page tome. It covers every possible nuance, from the hypothesis and research behind the drug to the goals, criteria, and requirements for participation. Whether the information is gleaned from principal investigator meetings, in-service tutorials, or other sources, mastering the fundamentals and logistics of a protocol is critical in running it correctly and consistently with other centers so results are valid.

“If there are too many variations, the sponsor can’t tell what’s causing a problem,” says Lynn Fukushima, RN, MSN, FNP, MBA, CCRC, nurse coordinator for the Keck Medical Center of the University of Southern California. “Is it the proposed medication itself or something else? We have to be very meticulous in our record-keeping so there’s no doubt.”

Fukushima wears many research hats in navigating drug studies related to cystic fibrosis and other pulmonary or lung diseases. For starters, she also helps her physician-colleagues determine if a clinical drug trial is appropriate by submitting information to the institutional review board for an up-or-down decision. Because her job includes budgetary tasks, she earned a health care administration MBA to better grasp the financial implications of a study.

In terms of each protocol, Fukushima sometimes works alone, organizing all aspects of a study, while other times, she’s coordinating with staffers. Whatever the case, her patient involvement changes with each trial stage. Phases I and II, for instance, can be intense since researchers are looking closely at efficacy and safety. She may see subjects weekly, daily, or even several times a day for blood draws and other procedures. During phases III, IV, and post-marketing, the individual interaction diminishes since sponsors are no longer tracking efficacy, but safety in an expanded universe of patients.

Whatever the stage, the paper chase with a clinical drug trial demands the kind of attention to detail and familiarity with medical jargon and charts that usually fit nursing professionals to a T. The skills you’ve likely established in training and honed in practice can provide an important cornerstone for managing the administrative and patient-contact components of any given study. But it’s also the ability to stay up-to-speed, think outside the box, and respond with on-the-spot analysis or critical thinking that’s important. Each protocol is replete with guidelines, but you still need to accommodate new information and unexpected turns-of-events.

In managing a support service unit for principal investigators throughout Washington University School of Medicine, St. Louis, Banez-Muth is used to the structured training and continuing education necessary to get a trial up, running, and producing valid results.

Of the 35 to 40 active NIH- and industry-sponsored studies she and her seven coordinators target at any given time, the phase II to IV drug trials represent a spectrum of urological and gastrointestinal targets. Whether Banez-Muth is personally managing a trial for a principal investigator or overseeing the work of others, she not only has to be organized but nimble on her feet. “As black-and-white as you would like things to run, it’s never that way. There’s always one patient who falls outside the box,” she says. “When that happens you want to make sure that you’re doing what you can to keep this person safe during the protocol.”


From Tuskegee to Transparency

Indeed, beyond data integrity, the primary task of nursing professionals involved in a clinical drug trial is to protect the subjects they seek, find, vet, enroll, and follow. From the moment coordinators scan medical records, tap health care providers, or reach into the community to find subjects, their focus has to be on complete honesty and concern about someone’s health and well-being.

That wasn’t always the case, given this country’s sometimes chilling research history, especially in regards to minorities. The infamous Tuskegee syphilis experiment, for instance, may have started in 1932 to chart the progression of an untreated sexually transmitted disease in black sharecroppers. Yet, by the time it ended in 1972, it had put hundreds of them at medical risk because US public health scientists and their local physician-partners withheld what had become standard-of-care treatment: penicillin. Even decades after whistleblowers shut it down, Tuskegee has left an indelible mark, particularly among African Americans.

Thankfully, clinical trials today are light years from Tuskegee, not just in terms of bioethical standards but also in practical safeguards. Study coordinators can point to a drug process so rigorous and regulated by the sponsor, the FDA, institutional review boards, and other agencies that safety rules at every turn. Patients are monitored so closely with high-tech imaging and other services that care often exceeds what they receive nominally from their personal physicians. “The wonderful thing about research is that you get excellent follow-up care,” says Menefee. “It can be a very special opportunity for participants.”

But nurses must be both transparent and on their toes in engaging candidates with a medical history that matches a given protocol. Informed consent is the primary tool they hold in their quiver to ensure that every enrollee understands every relevant specific—possible risks, benefits, and commitments—of a given study. But in outlining the parameters, they also target their rights. Distilling the caveats is important for every clinical trial, especially those that demand much of a participant, perhaps even an invasive procedure, with no guarantee of positive results.

In fact, making promises that someone will receive an active ingredient or that it will work with no side effects, is a trial taboo. The only guarantees nursing professionals should be sharing with their enrollees are that they’ll be good patient advocates, pursuing everything possible to ensure a safe experience. That includes collecting vital signs and good data with each office visit, addressing any side effects or adverse events, and keeping everyone, including a patient’s personal physician, apprised of important changes. As one coordinator notes: “You’re asking people to participate in a clinical trial from which they may or may not derive any benefit. So establishing trust and rapport is important.”

Whatever the specifics, vetting presents a great opportunity for minority nursing professionals to convince fellow patients of color that their participation in a study is critical. Given your own sensitivity to the cultural mores and concerns of a community, you can be a key link in dispelling any myths about drug research while bringing volunteers into the fold.

In engaging her enrollees, Thomas, for instance, makes sure they know that they’ll never be asked to sign on to a Baylor study without someone reviewing every paragraph of the consent form with them. More importantly, if it’s not a good fit, they can leave at any time. “I understand the sensitivity among African Americans enrolling in research studies,” she says. “Hopefully I can educate them so they have a good understanding and they’re willing to say, ‘OK, I will participate in this.’”

Similarly, when Judith A. Rivera, MSN, recruits subjects for both NIH- and pharma-sponsored memory trials, her goal is to find an ethnically diverse pool of people when the study merits it. As a Latino nurse practitioner and principal study coordinator for the University of California-San Diego’s Comprehensive Alzheimer’s Program, Rivera is well aware that dementia is a serious health issue among minority, as well as majority, Americans. Unfortunately, in some ethnic communities memory loss is often dismissed as simple aging rather than a potentially serious disease.

But by targeting culturally and racially diverse subjects for a slew of drug and other studies related to memory, researchers at her institution are giving vital information to pharmaceutical companies about all of the people, not just Caucasians, who might need their products. More importantly, they’re also raising awareness among enrollees about the potential pharmaceuticals—albeit under study—that might help them remain active and functioning. “We want them to be as independent as possible for as long as possible.”


Monitoring for Safe Outcomes

Making sure that a participant isn’t compromised during a drug trial is an important part of realizing any positive results. From phase I to post-marketing, nursing professionals are not only helping patients navigate the terrain of a protocol, but they’re also gathering information about a drug’s safety and effectiveness.

Detecting and forwarding potential problems to a sponsor is a natural for nursing coordinators since their training and frequent interactions often give them a pulse on what people are experiencing. “Some nurses have a sixth sense about how a patient is doing,” Fukushima says. “If they see a frown on a face or hear unusually short answers, they may be a little more aggressive in investigating the cause.”

But overseeing a clinical trial isn’t the only way to determine if a drug is working well or not so well in a patient. In fact, many nurses are finding satisfying ways to use their critical thinking and detail skills in other research-related venues. From pharmaceutical companies to clinical research organizations (CROs) and other patient service firms, prospects abound for managing and monitoring trials as well as educating and tracking subjects. Besides sales and marketing functions to promote approved products further down the line, the activity usually centers on making sure medications aren’t hurting users.

As a clinical safety specialist for GlaxoSmithKline’s (GSK) Global Clinical Safety and Pharmacovigilance Division, Shannon Hart Anderson, BSN, RN, JD, also manages adverse event reports—unexpected and potentially harmful reactions—for a bevy of pharmaceuticals bearing the GSK imprimatur. From over-the-counter remedies to prescriptive medications, her potential targets include therapies for a wide spectrum of benign and serious diseases. “We’re like the safety police,” she says, “We have to make sure that our products aren’t harming the public.”

From her berth in GSK’s US headquarters located in Research Triangle Park, North Carolina, Anderson processes initial complaints from consumers, health professionals, sales reps, and even the FDA. She then collects follow-up information, which is entered into a safety database that serves as grist for further investigation as well as the regulatory agency reports she also must prepare. To capture the most accurate information possible, Anderson routinely relies on the logical reasoning, problem-solving, and even communication and advocacy skills she’s honed as both a nurse and an attorney.

But the most important roadmap may be the positions she’s held previously with CROs, outside firms hired by a pharmaceutical company to provide a wide range of support services. That may include managing the day-to-day operations of a drug study or even serving as an outside monitor, making sure that each site follows a protocol correctly and meets FDA standards. In honing the pharmacovigilance skills she now uses at GSK, Anderson mastered the nuances of adverse event reporting and the importance of being detail-oriented as a drug safety scientist. “We need to know the ins and outs of what happens,” she says, “so that we can look for trends that may prompt us to change our label or even our product.”

Likewise, as a diabetes-musculoskeletal medical professional for Indianapolis-based Eli Lilly and Company, Marla Neal, RN, BSN, MHCA, educates health professionals about drugs and devices that may help their patients. When physicians and other practitioners pose questions of the sales force, she’s tapped to provide the definitive answer. Neal accesses every possible database and medical professional to respond to each request. She also updates sales members about current clinical trials while helping them understand how each Lilly product impacts a disease process.

But it’s her other priorities—capturing accurate information about unexpected side effects and product complaints—that really tap her nursing skills. “Oftentimes patients don’t even realize that they’re having an adverse event,” she says. “So I’m very diligent about asking the direct questions and picking through the subtle conversation for clues. It’s critical for making sure that our drugs are really improving the lives of our customers.”

Adds Shannon Bradley, RN, a telehealth nurse educator and team lead for The Lash Group, a Charlotte, North Carolina-based patient services support company: “When you’re speaking to someone on the phone, you need to ask the right questions because people don’t always come forth with information on their own. You have to help them identify what’s important.”

Bradley is the nursing voice on the other end of the line when patients, pharmacists, and other health care professionals make contact with her company’s Dallas office, usually by dialing the “800” reporting number on a medication’s packaging. Using her clinical intuition, honed as a hospital neonatal intensive care unit and trauma nurse, she collects and reports adverse events linked to medications manufactured by one of her firm’s pharmaceutical company clients. It’s a varied list, from digestive and fertility drugs to oncology and neurology medications.

But her primary role is often to educate and support patients in staying the course with their medication. For no matter how many drugs move from clinical trial to market, they aren’t effective if they’re not taken according to directions. “We want them to understand,” she says, “the significant impact medication compliance has on their therapy outcome.”


Reaping Rewards: Better Health and Other Benefits

Besides bedside nursing, there may not be a better way to use your skills and intuition than in drug development. You might not be the academic researcher or laboratory scientist behind a preparation, but you can help bring a drug the final distance via other roles. Truth is, by participating in the process once it involves ordinary people, you’re witnessing cutting-edge medications making dramatic differences in the quality of real lives. A grandmother who couldn’t comb her hair or walk without a cane before an arthritis drug trial, for instance, performs both tasks eight months into it. A grandfather who couldn’t play with his grandchildren now travels across country to romp with them.

As to Menefee, the landmark A-HeFT trial left her with many good feelings about being a co-investigator in the drug improvement process. Even though she didn’t place many African Americans in the trial, the protocol has worked so well since that now whenever a black heart failure patient in her practice meets the medical criteria, she prescribes ISDN/HYD to optimize their other meds. She hasn’t been disappointed yet.

The medication duo not only gives her more options in extending quality of life, but also serves as proof that research works. Every trial success, as well as every study failure, just reinforces her belief in the benefits of being part of the process. “Before a drug is even approved, I already know something about it,” she says. “So when it’s brought to market, I don’t need a sales rep to tell me how great it is. I know because I’ve already been involved with it. I’ve seen it work!” MN


Running the Gauntlet

The lengthy and complicated process of moving a drug to market is broken down into various phases. After a pre-clinical development stage during which animal and other laboratory tests have proven that a product is initially safe, the emphasis shifts to human or clinical trials. Although most drugs never reach that stage, the ones that do undergo a rigorous process in winning FDA-approval.

           Phase I: A drug is tested on 20 to 80 healthy volunteers not only to see if it’s initially safe but also to determine the most frequent side effects.

•           Phase II: If the drug hasn’t produced unacceptable levels of toxicity during the first phase, it’s tested in a few dozen to 300 subjects with the condition or disease to obtain preliminary data on how well it’s working.

•           Phase III: If a drug demonstrates a good level of effectiveness, it’s tested in an expanded pool of subjects, from several hundred to about 3,000, to see how it works with different dosages, populations, and in combination with other drugs.

•           Phase IV and other post-marketing studies: Conducted after the FDA has approved a given drug, these trials are used to gather additional information about safety, efficacy, and even other uses.


Ethnopharmacology: What Nurses Need to Know

Ethnopharmacology: What Nurses Need to Know

Nurses can play a key role in incorporating ethnopharmacology into everyday health care practice. Yet many nurses still know little to nothing about this emerging field of science.

Josepha Campinha-Bacote, PhD, MAR, APRN-BC, CNS, CTN, FAAN, the president and founder of Transcultural C.A.R.E. Associates in Cincinnati, is one of nursing’s leading authorities on ethnopharmacology. Yet 15 years ago, she says, she had never heard the term; a patient brought it to her attention.

Today, Campinha-Bacote, who has given more than 1,000 presentations on transcultural health care issues, always includes ethnopharmacology–also known as ethnic pharmacology, cross-cultural pharmacology, transcultural pharmacology and interethnic pharmacology–in her lectures.

“When I do [a presentation to] an audience of 500 to 600 and ask how many people have heard of ethnic pharmacology, only one or two say they know about it,” she says.
Often the term is simply defined as the correlation between race/ethnicity and how a person’s body metabolizes medications. But that connection is just one small aspect of this growing field. Ethnopharmacology does deal with how physiological and genetic differences between racial and ethnic groups impact the effectiveness of pharmacological products. However, it also looks at how people’s cultural beliefs about their health have an impact on the medications they use and how they use them, as well as how racial bias and cultural attitudes affect the development and prescribing of certain drugs.

“I define ethnic pharmacology as the field of study that investigates the impact that culture, environment, genetics, biophysiology and psychosocial factors have on the prescribing, metabolism of and response to medications,” says Campinha-Bacote, who has also written extensively on the topic. Her most recent article, “A Culturally Conscious Model for Addressing Racial and Ethnic Disparities in Ethnopharmacology,” was just published in September’s issue of the Journal of Psychosocial Nursing and Mental Health Services.

Cora Muñoz, PhD, RN, a professor at Capital University School of Nursing in Columbus, Ohio, and Cheryl Hilgenberg, EdD, RN, CTN, a professor of  nursing at Millikin University in Decatur, Ill., have also co-authored a paper on this topic. Their article, “Ethnopharmacology: Understanding How Ethnicity Can Affect Drug Response Is Essential to Providing Culturally Competent Care,” was published in the August 2005 issue of the American Journal of Nursing (AJN).  

“The takeaway message is that all health care practitioners need to understand that [certain] medications are absorbed and metabolized differently by people of color,” Muñoz says. “This is supported by research in the past 15 years on some of the drugs, particularly the hypertension and psychotropic ones.”

The other key message, says Hilgenberg, is that health care practitioners must realize the necessity of doing a cultural assessment for every patient. “That [assessment should] take into consideration [the patient’s cultural] values and practices [and how they influence the effectiveness] of all our treatment [paths], not just medications.”

Genetics Makes a Difference

Even though the findings of the Human Genome Project show that all human beings are about 99% the same genetically, race and ethnicity do play a role in how a person’s body absorbs and metabolizes certain medications. But this impact isn’t always known, because most drugs are tested primarily on Caucasian males. For decades, racial/ethnic minorities and women have been excluded, or severely underrepresented, in clinical trials for new medicines.

As a result, Campinha-Bacote says, “All of these side effects and indications are ‘normed’ mainly on the white population. So you can imagine why there are going to be all these other side effects on different [minority] populations, because [the drug] hasn’t been tested [on them].”

Barbara Jones Warren, PhD, PMH-APRN, BC, an associate clinical professor at the Ohio State University College of Nursing in Columbus and executive nurse for the Ohio Department of Mental Health, explains that a person’s “genetic loading” is the key. “If you are talking abut individuals, no one–unless you get a genetic profile–knows what his or her genetic loading is. Based upon genetic loading, for the most part we are 99.9% alike genetically. It is that one-tenth that makes the difference and causes individuals to react differently to medications. While it doesn’t sound like much, that tenth of a percent .”

For example, says Warren, who is of African American and Native American descent, “Certainly I react differently to meds based on the genetic loading from both of [those two ethnicities].”

These small but crucial genetic differences can also have an effect on how a minority patient’s body reacts to the often-substituted generic forms of prescription drugs. Campinha-Bacote believes this is a factor that many clinicians do not take into account when prescribing medications.

The problem is that primary care providers often prescribe the trade name medication, but a pharmacist may fill the prescription with its generic form. Generic brands have “fillers” in them, Campinha-Bacote explains, which can change the effectiveness of the medication for some groups of people.

“While up to 80% or 90% [of what’s in the generic brand] is the drug, [there can also be] fillers in it. One of the fillers that is lactose,” she says. “Certain ethnic groups, specifically Hispanics and African Americans, are lactose intolerant. So you can see [why a patient] might say, ‘I do well on Motrin but not Advil.’ The average doctor or nurse might say, ‘They are the same–they are both ibuprofen.’ But for some people the trade name drug works more effectively.”

Physicians may also give patients samples of brand name medications. “And if it works, then they go to the pharmacy and get the generic form,” Campinha-Bacote says. “Then they go back to the doctor or nurse [practitioner]’s office because they are not doing well on the medication and you wonder why. It is because they were switched from a trade to a generic form of the drug.”

The Role of Culture

Culture plays a major role in shaping people’s health beliefs and practices, including their attitudes about taking medicine. This, in turn, can have an impact on a patient’s adherence to a prescribed medication regime.

“You have to look at the cultural beliefs and values and then the whole connection to pharmacology,” Warren says. “That is just as important [as race and ethnicity]–what are the cultural beliefs that [influence] why people take a medication or why they don’t.”

Muñoz agrees, adding that “dietary factors and environmental factors [also play a role]. There are multiple factors [involved].”

Still another consideration is the emergence of new immigrant populations whose cultures are unfamiliar to American health care professionals. “For example, in Columbus we have an increasing number of people from Somalia and other African countries,” Muñoz says.

Since nurses are on the front lines of patient care, they are uniquely positioned to gather and assess this essential cultural information. “[Nurses need to know how to] include questions in their cultural assessment that will elicit responses that will give them cultural data,” Muñoz comments. “If [cultural considerations] are not included in the questions they ask the patients, generally [the patients will not volunteer that kind of information].”

When conducting a cultural assessment, how the nurse phrases the questions can be critical. “[One] culturally sensitive technique is to frame questions in the context of other patients or family members,” says Campinha-Bacote. “For example, a nurse can say, ‘I know another patient who thinks that they will lose control if they take a psychiatric drug. Do you think that?’ or ‘What does your mother think of taking medication?’ Attributing explanations to another person can help patients disclose health beliefs and practices that they may initially feel uncomfortable expressing.”

Knowing how to ask the right kind of questions can ultimately affect how well a medication is able to help a patient. “They might not tell you about the side effects,” Campinha-Bacote notes, “and then you keep increasing the dose and that can be a problem.”

The cultural assessment should also seek information about the patient’s use of traditional medicines, such as herbal remedies, to treat their illness. In some cases, these herbal medications can interact negatively with a physician-prescribed pharmaceutical, causing adverse effects.

Muñoz says patients may not readily tell their physician that they are taking these traditional remedies, for several reasons. For example, they may not offer the information because they are not asked about it directly, or they may simply be embarrassed to discuss it with a physician who is not familiar with their culture.

A clinician’s beliefs and biases about a racial, ethnic or cultural group can also influence how medication is prescribed and therefore, how effective it is for a patient. Campinha-Bacote points to a study that looked at how psychotropic drugs were prescribed to European American versus African American teenagers.

Both groups of teens were tested and had the same “psychotic score.” Yet, even though all of the adolescents had severe mental illness, the black youths were more likely to be prescribed psychotropic medications than the white youths.

“Even when you have two identical groups with the same level of psychotic symptoms, the psychiatrists perceived African American adolescents to be more aggressive and more psychotic, so they prescribed the antipsychotic [drugs] more often,” Campinha-Bacote explains. “Biases and the skills in how you assess different cultural groups can affect the prescribing of medication.”

Expanding the Research

Ethnopharmacology is still a new and evolving science. In recent years a growing amount of research on the topic has emerged and more studies are being added as awareness continues to increase.

“[Some] practitioners [still] seem to think that since medications go through clinical trials they should be effective for all people in the same way. That is a myth; they are not,” Muñoz says. “The clinical trials [have been] primarily [conducted] on the white population, mostly men, and [the results are] generalized to women and minorities.”
But now, she continues, researchers across the health care spectrum are realizing that this approach “is not appropriate anymore. Fortunately, [more pharmaceutical companies] are recruiting minorities into their clinical trial studies, so we should be able to find out whether or not medications are effective across the board.”

Over the last five to six years there has been a lot research focusing on metabolic issues in individuals across cultural groups, according to Warren. Much of this work, she adds, is being done by multidisciplinary teams of researchers, including nurses. And that means culturally sensitive minority nurse scientists can make particularly important contributions.

Barbara Jones Warren PhD, PMH-APRN, BCBarbara Jones Warren PhD, PMH-APRN, BC

“I think when [researchers] are working in groups and are looking at whatever the phenomenon is, they certainly [need] to look [at cultural issues] to see if people are reacting differently. There are a lot of clinical trials where nurses are the project managers, so that is an excellent opportunity to bring [those issues] up,” she explains. “[Nurses] need to say, ‘We have to make sure that we get enough [minority] individuals in the study to be able to really look across the [cultural] groups and see what are the similarities and what are the differences.’”

Clinical trials also need to be specific in how they categorize people, says Hilgenberg. “It is important to realize that even in the U.S. Census we tend to divide people into these huge groups–Asian, Hispanic, black and white–but there are great variations even within those groups,” she points out. For example, within the “Hispanic” category, “Puerto Ricans might [have different cultural issues] and respond differently [to a drug] than Mexican Americans or South American Hispanic people. We need to be more precise in how we really describe ethnicity.”

Every person is different, Hilgenberg stresses. “But I think [this kind of] research alerts you to different health care risks and needs in patients [from different ethnic groups] and [the need] to be more tuned in to those differences [when you are doing] your assessments.”

As the American population becomes increasingly diverse, patients do not want to all be treated alike, she adds. “They want their values and practices respected, which might not be those of the nurse or the patient next to them. The whole idea of continually individualized care, and taking into account the cultural aspect, has become more and more important.”

The Nurse’s Role

Since nurses are responsible for monitoring the effectiveness, side effects and adverse effects of medications on patients, they can play a key part in bringing the science of ethnopharmacology forward. Muñoz underscores that nurses have a very important role as patient advocates, which makes them natural candidates to use this science in their practice.

“The nurse can assume the role of advocating with the physician as far as what medications might be most effective for the patient, knowing the patient’s cultural and ethnic background,” she says. “The physicians prescribe, but they are not there 24/7 to see if there is a positive or negative clinical response. It’s the nurse’s job to [monitor that information] and report it to the physician.”

How can nurses learn more about ethnopharmacology? Campinha-Bacote, whose Web site has a whole section devoted to the subject (see sidebar), says there are enough lay articles available in the literature for nurses to familiarize themselves with the basics. In fact, she adds, there is no reason today to be uneducated about this topic.
“Just read a little bit,” she advises. “I suggest journals such as the AJN, which have easy articles [to understand] and other journals for student nurses and staff nurses.”
Just because the average staff RN doesn’t have prescriptive authority, that doesn’t mean he or she doesn’t need to be knowledgeable about the cultural aspects of pharmacology, Campinha-Bacote maintains. “You cannot say, ‘I am not prescribing it, [so I don’t need to know],’ because you are [administering] it. And if there is a lawsuit and you are the one who gave [the medication to the patient], then you can be sued too.”

Muñoz believes nursing students at both the undergraduate and graduate level should be learning about ethnopharmacology while in nursing school. “That training gives them a good foundation,” she says. “When they are in practice there is also a need for continual training, because it is not possible to know everything about the values and practices of all cultures.”

To be culturally competent is an ongoing process, Muñoz concludes. “Hopefully new graduates [will] have the foundation in their curriculum,” she says. “And when they are [practicing nurses], hospitals will hopefully continue to provide this training, not only for [their nursing staff] but for all people who are involved in health care service.”

Making a Switch: Nursing Careers in Pharmaceutics

For two weeks each month, Aretha Thurman trains 12-20 new sales and sales support hires for Medtronic, a medical technology company in Minneapolis, Minnesota. She makes sure the students—a mix of nurses, physical therapists, and others—can operate the company’s chronic pain management devices.

By training’s end, her new colleagues are ready for hands-on work with a field instructor, a mentor who will help them develop their customer, presentation, and troubleshooting skills. It’s a multifaceted training, and Thurman needs the new hires to understand how their relationships with both physicians and patients are about to change. Instead of taking orders from a doctor or caring for a patient, they will be consulting customers.

“It’s not so much that you’re not a patient advocate, but your focus is more on the company,” Thurman says. “You can’t lose sight of the business side, since every interaction can have a positive or negative affect that can mean your job.”

Challenge seekers looking for a change of pace should consider a career in the pharmaceutical or medical device industries. They are radically different from the patient-centered work you’re accustomed to, but if you’re looking for a career change, these fields are ripe with benefits. The perks of increased salary with access to commissions, discounted stock options, and generous 401K plans are, of course, met with a few challenges. People who succeed in for-profit’s fast-paced, bottom-line environment not only routinely work long hours, but they’re also willing to step out of their comfort zone to prove their worth.

Although product demand is expected to remain strong during the next decade, the Bureau of Labor Statistics forecasts an employment increase of 6% through 2018, slightly lower than all manufacturing combined. Several factors—including an emphasis on cost-effectiveness and the expiration of many brand-name drug patents—may limit employment opportunities, particularly in the pharmaceutical sector.

Yet, as a minority nurse, you may have a decided edge on the competition; companies are always looking to diversify with quality people who understand the human body and can relate to a community. Opportunities exist in sales, research, and other technical jobs—as a nurse, you’re well suited for any of them.

“Nurses are perfectly prepared for corporate America,” says Beverly Malone, Ph.D., R.N., F.A.A.N., Chief Operating Officer of the National League for Nursing in New York. “They’re the rare professionals who can walk into a stranger’s room and within several minutes start doing or talking about something very personal. In terms of their flexibility, creativity, and ability to work with people, they’re incredibly well prepared for these kinds of roles.”

The following is a glimpse at six unique job opportunities in pharmaceutical and medical device industries, from the experience necessary to the perks to the potential pitfalls.

Clinical research associate

If you’re an analytical thinker who’s always eager to check out the latest and greatest in medical advancement, becoming a clinical research associate (CRA) may just satisfy your inquisitive nature. Because CRAs monitor patient data and testing results for clinical trials, they perform important functions in the research and market launch of new therapies. CRAs track statistics about study participants that they likely will never meet but whose data are key to FDA approval. Besides being sticklers for documentation, they must also be comfortable interacting with health professionals who carry out those studies.

“It’s very helpful to have someone who understands the inner workings of a hospital, is able to network with medical staff, and can discuss research findings with physicians,” says Ed Campanaro, M.S.H.S., B.S.N., Vice President of Clinical Operations and Data Management for Cubist Pharmaceuticals in Lexington, Massachusetts. “Nurses are very well prepared to review the complex clinical data generated by study participants and, in many cases, discuss those findings before reporting the results. It’s certainly value-added when you have someone in these positions who is medically trained.”

CRAs often work for contract research organizations (CROs), independent firms that supervise trials for sponsoring corporations. Many recruiters suggest a CRO as the perfect stepping-stone from clinical nursing into research, especially if you’re a new B.S.N. graduate. It allows you to hone your study monitoring skills and product line knowledge.

When Norma Rodgers, B.S.N., R.N., A.C.R.P., joined Research Pharmaceutical Services, a CRO in Ft. Washington, Pennsylvania, as a senior clinical research associate in 2007, she brought other CRO monitoring and oncology nursing experience. Both helped prepare her for tracking phase one and two trials for several oncology and anti-infection drugs.

Her work involves both learning protocol and certifying that doctors and staff are qualified to conduct the study at hand, trained in the ins and outs of the processes. After patients are recruited, she tracks participant progress while ensuring that investigators are executing the procedures appropriately. “If doctors and staff aren’t doing the study correctly, then you have issues,” Rogers says. “You don’t know if the drug is actually working or you’re getting results that you’re either not looking for, or shouldn’t be.”

When Rodgers joined her first CRO, she negotiated a lateral financial move that allowed her to earn the same money she made at the bedside but without shift, weekend, and overtime differentials or extra pay as a charge nurse. She also earned several bonuses. Experts say CRAs with two to five years of experience can earn between $60,000–$70,000.

In the meantime, Rodgers travels three to four days a week from her Plainfield, New Jersey, home base, covering medical centers in three northeast states. Besides dealing with the paperwork of a highly regulated field, the biggest challenges involve keeping many personalities in the loop and responding quickly. “Things don’t always go the way you want them to go,” she says. “Fortunately, as nurses, we’re flexible.”

Safety monitor

If you’re interested in ensuring patients a safe experience during a clinical trial, you can find ample opportunities in both the medical device and pharmaceutical worlds. Both use nurses to monitor any untoward events that might be linked to products being marketed or clinically tested. They’re responsible for tracking and referring all reports to the FDA and other regulatory agencies.

 As part of Eli Lilly’s Global Patient Safety division, associate consultant/case manager Dorothy Jackson, B.S.N., monitors safety issues for 18 cardiovascular and endocrine clinical trials. From the company’s Indianapolis headquarters, she triages daily reports from physician-investigators, making sure they’re entered into Lilly’s safety system for proper disposition. She also reviews site protocols after incident reports are filed to guarantee everything is in order. In addition to all that, she’s the back-up to another team leader who oversees all trial safety aspects, from launch to completion.

Jackson routinely relies on the critical-thinking skills she learned in nursing school and honed as a surgical nurse. Before coming to Lilly as a contractor in 2006 and employee in 2007, she served as a clinical research coordinator, managing company-sponsored cardiovascular and diabetes studies for a cardiology group.

Because of her experience, she can offer a quick assessment when an investigator reports that a patient on a Lilly drug experienced a side effect. What might have caused it? Was it expected? And what did the doctor do in response?

In terms of other prerequisites for the job, Jackson cites solid clinical experience, as drug development requires grounding in the disease process. Also, with patient safety at the forefront, there’s little margin for error, so tight organizational and management skills are imperative. You also have to view patients from a different perspective.

“When you work in a physician’s office, your focus is on the individual,” Jackson says. “But in the corporate world, there are thousands of patients. You’re focused on a whole population of people. You want to know, ‘How is this outcome going to affect them?’”

Certified diabetes educator

Minority nurses who’ve paired their B.S.N.s with diabetes specialty training can not only enhance their careers via various corporate roles, but can also help their communities. By representing manufacturers dedicated to cutting-edge therapies, certified diabetes educators (CDEs) raise awareness and even prompt others to be proactive about their health.

 “If minorities are overrepresented in certain chronic diseases, such as diabetes, companies limit their market opportunities if they don’t pull in minority nurses to help educate the community about a product.” says Yvonne Wesley, Ph.D., R.N., F.A.A.N., Director of the New Leadership Institute for Black Nurses at the NYU College of Nursing.

As a regional clinical specialist for Roche Diabetes Care, Beverly Hawkins, M.S.N., R.N., trains physicians and diabetes educators on the company’s insulin pump, the ACCU-CHEK® Spirit. When Hawkins joined Roche in 2006, she brought both years of experience as a nurse educator and her American Association of Diabetes Educators certification to the company.

Working out of St. Louis, Missouri, Hawkins travels to hospitals and private practices throughout several Great Lakes states, where she not only makes presentations to health professionals but also teaches consumers how to use the product. Hawkins credits her years as a medical-surgical and charge nurse for exposing her to different patients and helping her juggle many tasks.

Also, the beauty of traveling for her job is that she sees how different people address this disease. Although diabetes manifests itself in a fundamentally similar way in everyone, educators have unique styles of presenting material, while patients take in the information in their own way. She’s constantly adjusting her delivery.

“You have to be innovative sometimes,” Hawkins says. “You may go into an office ready to train 10 people and only one shows up. Or you may be prepared for one and 10 show up. With this job, you have to be able to make adjustments.”

Medical information specialist

If you’d like to empower people by dispensing clinical knowledge over the telephone, you may find your niche in a company call center. Many manufacturers staff telephone banks so health providers and consumers can get quick answers and immediate help.

 “Our goal is to deliver the right medications to the right patients at the right time,” says Kathleen Bos, M.D., Vice President of U.S. Medical Affairs for the biopharma corporation UCB in Brussels, Belgium. “That takes understanding both medicine and how to care for a patient’s needs. Nurses have the necessary skill set, so hiring them in these roles is very complimentary.”

As a UCB medical information associate, Debra Curry, B.S.N., is often the first contact health professionals and consumers have with her company. She fields communication in UCB’s Atlanta, Georgia, call center. On any given day, her conversations may pivot from specific drug inquiries to information on research trials. She’s also charged with handing off any adverse effects about a product to UCB’s pharmacovigilence (PV), or drug safety, department, which has an additional call center to further investigate complaints.

What does she rely on from her nursing background? Curry uses her knowledge about physiology and pharmacology, as well as the therapeutic information she’s gleaned over many years as both a hospital and ambulatory clinic triage nurse. Those experiences have helped her not only assimilate and understand UCB product information but also describe clinical trials concerning them.

Besides sharpening her oral presentation skills and broadening her computer capabilities, the biggest challenge for Curry was in her approach to patients. As a clinical nurse, she was accustomed to finding and fixing people’s medical complaints. But now she empowers them with information so they can partner with other caregivers. “I was used to giving patients what they needed immediately. So I had to switch hats.”

Besides working an enviable (at least from a nurse’s perspective!) 8:00 a.m. to 5:00 p.m. day, Curry points to a compensation package that topped her former clinic salary, plus corporate perks such as tuition reimbursement exceeding $5,000 a year. After finishing her M.S.N. in 2011, she intends to pursue a Ph.D., possibly in pharmacology. Her goal is to become a medical science liaison, a field-based professional who discusses data on UCB products with the medical community.

“When you educate, your impact goes beyond just that one-to-one experience of patient care,” says Bos. “You have the plus of knowing that what you do really can have a ripple effect on a much broader audience.”

Sales representative

Ready to close the deal? As a salesperson, you’d be persuading physicians and decision makers to buy your company’s product, while boosting your personal earnings beyond an annual salary. Sales reps earn bonuses or commissions that can increase their earning power into six figures.

Pharmaceutical sales reps “detail” drugs, meaning they’re trying to influence physicians to write more prescriptions for their company’s products. Medical device sales reps work aggressively for an equipment purchase order. Although autonomy is a feature of both jobs, there are downsides. You may be working well into the evening, especially if you’re demonstrating a device in surgery. Salespeople might also become disenchanted with the travel and routine.

“If you come to a pharmaceutical sales job with expectations of using your clinical nursing skills to enhance it, but then discover that what’s really required is detailing products or entertaining staff, you may feel very unchallenged,” says Manny Barrientos, head of the Jacksonville, Florida, recruiting firm, The Wolfgang Group.

But if it seems like a fit, you may find sales both lucrative and fulfilling. When Chip Mitros, B.S.N., joined Medtronic in 2005, he believed becoming a neuromodulation associate sales representative would move his career in directions he couldn’t achieve at a level-two trauma center. Two promotions later, Mitros heads a five-member sales and support team in South Bend, Indiana, whose products include two implantable pain relief systems. An essential aspect of his job is knowing each system well enough to troubleshoot any problem for the neurosurgeon implanting it. “We’re more than just delivery people. We have to know these systems like the backs of our hands to get the result we’re after.”

Although Mitros’ calling card is his clinical knowledge, nurses need assets other than a kindred spirit to succeed in sales. Top performers not only relate to others but have the desire to win. “To be successful,” says Bo Burch, Chief Principal of the Wilmington, North Carolina, recruiting firm, Human Capital Solutions, Inc., “you have to have the passions and personality of a hunter. You need to be highly driven.”

If that sounds familiar, you can count your rewards in bonuses and/or commissions. A base salary for new pharmaceutical reps tends to be lower than clinical pay ($50,000–$60,000), but annual bonuses ($15,000–$20,000, for starters) sweeten the package, which typically increase over time.

Although beginning salaries for medical device reps are even lower at $35,000–$50,000, the commissions generally make up for the difference. Based on a percentage of an equipment or device sale, they can range from $30,000–$70,000 during the first year. Once you’re at the top of your game, the numbers increase significantly.

Beyond the pay, however, there’s just the satisfaction of being an integral player in a dynamic venture. “I don’t feel like I’m just one of the numbers. I’m more of an individual,” says Mitros. “I have my own name. I’m not just the ‘night nurse.’”

Clinical sales specialist

Becoming a clinical sales specialist (CSS) may be the perfect career match for nurses who want to be part of a medical device or drug sales team but aren’t ready or eager to sell products. They support salespeople by demonstrating and/or troubleshooting products, from injectable drugs to implantable cardiac devices.

 Sometimes they work in tandem with sales representatives, both assisting doctors with surgical, catheterization, or other procedures using their product. Other times they’re on their own, running in-service training or follow-up clinics. In either case, they play a crucial role in making sure doctors, nurses, and even patients are well versed with their devices or drugs. To cement the relationships, companies usually gravitate to nurses already working in the specialty related to their product line.

“Their insights are focused on a product in a way that brings a whole new perspective to what it’s really all about—how it’s utilized and how it’s best marketed and sold,” says Cindy Stokvis, Senior Talent Acquisitions Specialist for Boston Scientific’s cardiology, rhythm, and vascular field sales organization. “They add a dimension otherwise missing in someone without the same background.”

When Nikki Cracknell, R.N., M.S., joined Boston Scientific’s cardiology, rhythm, and vascular division as a clinical education service specialist in 2009, she brought the perfect career mix to the job: a newly minted nursing degree along with a master’s in exercise physiology, plus previous experience in cardiac rehabilitation and exercise stress testing.

From her Charlotte, North Carolina, home, Cracknell travels throughout North and South Carolina, working with cardiologists and electrophysiologists as they implant the company’s pacemakers, internal cardiac defibrillators, and other cardiac rhythm or heart failure devices. Like her customers, she may have to get to the hospital on a moment’s notice. What’s more, she could be helping implant a device in one place and get called to another emergency room or inpatient check. “Everything is open to change, and change happens quickly,” she says. “You may be getting ready to do one thing and all of a sudden you’re doing something else.”

For nurses who don’t mind the personal intrusion, the rewards can be lucrative, with base salaries ranging from $65,000–$90,000 and annual bonuses of $10,000–$20,000, depending on the company, product line, and team performance. But there is a tradeoff. “The job really never ends. There’s not a start or end time.”

Yet it’s one of the best entries into a corporation and it also offers the best of two worlds. Cracknell says she can be supportive without having the stresses or responsibilities of direct patient care. Instead, she’s focused on assisting them and their physicians with her product consultation.

“For those who do it, there’s nothing more rewarding than representing truly lifesaving, innovative technology,” says Stokvis. “You’re contributing to something bigger than just a single practice or patient group. You’re giving many people exciting new ways to live life and be hopeful about their future.”

Getting started

Whatever path you pursue, there are general points to keep in mind. Most companies invest significantly in recruiting and training new hires. In terms of nurses, candidates usually have to have a B.S.N. degree. Sometimes an R.N. will get you in the door if it’s paired with a bachelor’s in another field. Like experience, the right degrees bolster your credibility.

 Most pharmaceutical and medical device manufacturers have rigorous training programs, with written assignments, tests, and even role-playing. You may not need an advanced degree, but your company will likely have a substantial tuition reimbursement program to encourage you to go further. In fact, the draw for most nurses who make the transition into corporate life is the many opportunities to climb the ladder or move laterally into jobs in marketing, product development, or project management. The first job is just a jumping-off point.

Since joining Medtronic in 1999 after years of intensive care nursing, Thurman transitioned from clinical specialist to her current role. Now she’s poised for her next step: a doctorate in nursing practice. She hopes to use it as a way to adapt her training methods to the changing business needs of a global company as well as her teaching career after corporate retirement. Her focus will be on the emerging field of informatics, the application of technology to medical information management.

In the meantime, Thurman offers this advice: “You have to assess whether or not it’s going to be a good fit. Business can be very lucrative, but it’s not a feel-good, hand-holding situation. It just depends on what suits you at this point in your career.”

Out at Work: Diversity in the Pharmaceutical and Biotechnology Industries

The U.S. pharmaceutical industry has been in a five-year hiring frenzy. IMS Health, a leading source of market information for the pharmaceutical industry, forecasts that both pharmaceutical and biotechnology companies will continue to experience growth that outpaces that of the overall economy for the foreseeable future. This steep growth curve spells opportunity for new college graduates considering a career in pharmaceuticals. The industry has recognized the value of attracting and retaining a diverse workforce and is actively pursuing graduates from many different backgrounds. Within many organizations, the workforce diversity they embrace not only encompasses race, gender and disability status, but also has been expanded to include lesbian, gay, bisexual and transgender (LGBT) employees.

What do you do if you are a gay man or lesbian looking for a job in the pharmaceutical or biotechnology industry? How do you know which potential employers have a demonstrated commitment to diversity and especially to their LGBT employees? An excellent place to start is the Corporate Equality Index published annually by the Human Rights Campaign (HRC) Foundation. HRC is an organization that works to advance equality based on sexual orientation and gender expression and identity. In 2003 the index rated 250 employers that can be found on either the Fortune 500 list of the largest publicly traded companies or the Forbes 200 list of the largest privately held firms. An additional 112 employers with at least 500 employees were also included. Companies were surveyed and rated on a scale of 0% to 100% based on seven factors that demonstrate how the companies treat LGBT employees, consumers and investors. Nineteen pharmaceutical and biotechnology companies were rated in this year’s index. Sixteen had scores of 57% or higher, indicating positive responses on at least four of the seven factors, with Bausch & Lomb Inc. scoring a perfect 100%. (To see how other pharmaceutical and biotech employers scored, see the chart below.)

Gaining the Support of Your Employer

One of the seven factors on the HRC survey is whether the companies “officially recognize and support a gay, lesbian, bisexual and transgender employee resource group; or would support employees’ forming a LGBT employee resource group if some expressed interest by providing space and other resources; or have a firm-wide diversity council or working group whose mission specifically includes LGBT diversity.”

Employee resource groups (also known as affinity groups) are expanding in number as more and more companies focus on diversity for a competitive advantage. However, groups often develop at the grassroots level, before formal diversity initiatives are in place. As corporate sponsorship increases, the groups can help spread diversity messages to the rest of the company. Resource groups are usually formed around what are known as the “primary dimensions of diversity”: age, race, physical disability, gender, ethnicity and sexual orientation.

Genentech, a biotechnology leader headquartered in South San Francisco, Calif., is a strong supporter of employee resource groups and offers one that focuses on LGBT issues. (See sidebar “Genentech’s Out & Equal Diversity Network Association”.) Sandra Manning, co-chair of Genentech’s Out & Equal (GO&E), states that “at Genentech, it is truly believed that when an employee can arrive at work free of inhibitions or worries, then that person will contribute fully to their work and to the company’s goals. That is what is so great about a corporate culture that embraces diversity.”

Resource groups work to support their companies’ business in four common ways:

Education. An educational forum is one of the most useful benefits a resource group can provide to both its members and the company. For instance, busy employees may not know all of the details surrounding the domestic partnership benefits that the company offers. (Lobbying to get them is often the first goal of a LGBT resource group if they are not already available.) The same holds true for benefits available to registered domestic partners in the states where the company does business, and updating members on pending legislative issues such as the Employment Non-Discrimination Act (ENDA). More ambitious projects include educating and increasing the awareness of all employees about their gay and lesbian colleagues.

Educational programs need not, indeed should not, be limited to LGBT issues. A powerful way to align the resource group’s objectives with those of the company is to sponsor lectures open to all staff members on professional development and corporate issues. For example, invite a senior manager from research, manufacturing or sales to speak about what their departments do and what their greatest challenges are. Other educational offerings can include maintaining a library of current books and publications relevant to LGBT professional issues, and facilitating a book club that covers general business and leadership related topics from a LGBT perspective.
Networking. Social events provide an excellent opportunity to meet with people from across the organization, which is good for exchanging information and developing professional contacts. Networking is an informal way to learn how different parts of the company contribute to the organization’s overall goals. Such knowledge is useful if you want to make a lateral move within the company, and it also becomes increasingly valuable as your career advances.

Genentech’s Manning says, “Since GO&E meets monthly to plan activities throughout the year, people attending the meetings make an impact on each other simply by introducing themselves. We meet new members who are from various departments in the company, we learn a little about our different roles, and how we each contribute to the goals of Genentech.”

Meeting gay and lesbian colleagues at higher levels in the organization also fosters mentoring opportunities. In addition, resource groups often have sponsors who are high-ranking employees within the company that offer advice and guidance on group activities. Membership in a resource group, and especially holding a leadership position, can provide access and visibility that might not normally be available in your job.

Networking opportunities can expand well beyond the company. Community outreach activities allow members to interact with LGBT philanthropic organizations. Connecting with other corporate LGBT resource groups in the same city and across your industry can infuse your group with new ideas and energy. Two formal programs provide a structured way for gay and lesbian professionals to come together: The Out & Equal Workplace Summit is an annual three-day event culminating in the Outie Awards Gala and the LGBT Leadership Institute sponsored by the Anderson School at UCLA offers a week-long symposium covering a full range of gay and lesbian employment and career issues.
Recruitment and Retention. Finding talented and highly skilled employees is a constant challenge for pharmaceutical companies. Once they find the right employees, companies want to keep them. Manning adds, “Genentech’s GO&E group works to help accomplish the goals of the company and, in turn, Genentech supports GO&E in order to retain its highly valued human resources.”

The presence of an LGBT resource group is a strong indicator of the corporate culture’s attitude toward and acceptance of gay and lesbian employees. The groups foster a sense of community within the company, and make a gay or lesbian employee more likely to stay. Often, personnel who have been hired recently are not only new to the company, but also new to the city. A resource group provides an immediate social circle and can help smooth the transition to the new area—this reduces stress and makes a new employee more productive, faster.

As the workplace becomes more open for gay and lesbian employees, and candidates become more comfortable addressing GBLT issues before they are hired, the demand for information on diversity policies and corporate attitudes will increase. Resource groups can assist on this front in several ways. They can help the company identify talent pools by providing the human resources department with recruitment contacts for LGBT professional societies and college or university alumni associations. Group members can serve on panels for human resources during the interview process. A savvy candidate may request an informational interview with a gay or lesbian employee before accepting an offer. New hire orientation packets should include contact information for all corporate diversity groups along with listings of local organizations and community events.
Community Outreach. Resource groups can do good deeds while also building the company’s image through community outreach programs. Activities can take the form of directed giving, volunteerism and corporate sponsorship. Directed giving involves identifying worthwhile charitable organizations that the group can support by combining individual member contributions. Corporate foundations may offer matching funds in addition to employee contributions. Volunteerism can be as simple as forming a corporate team for an AIDS walk or as complex as staffing an entire fundraising event.

Pharmaceutical and biotechnology companies have a vested interest in building strong science skills in school-age children. Mentoring high school students or sponsoring a science fair develops both goodwill and future employees. Finally, corporate sponsorship of gay and lesbian events sends a strong message of support to the community. Both Amgen(a global biotechnology company headquartered in Southern California) and Genentech have sponsored their local LGBT Pride events.

Opportunities to contribute can come from a variety of sources. The Amgen Network for Gay & Lesbian Employees (ANGLE) recently had an unexpected, but welcome, request. “A local elementary school asked for donations of age-appropriate books from each of Amgen’s affinity groups for their school library. The experience made me realize that our group can help shape positive attitudes toward gays and lesbians not only within the company but also in the communities where we do business,” states Durk Hubel, president of ANGLE. (See sidebar “Amgen: Lessons Learned From a Start-up”.)

Your Next Step

The HRC’s Corporate Equality Index is a unique and helpful resource, but it surveys only the largest U.S.-based companies. Don’t let a potential employer’s absence from the index hold you back. Check out the company’s Web site; it may have information on their commitment to diversity. Also, try calling the human resources department. Ask if they have an active LGBT resource group, and if so, whether you can have the group’s contact information. Employment prospects in the new millennium for both the pharmaceutical industry and LGBT professionals are looking very bright indeed.


BiDil Controversy Continues as FDA Approves First  “Race-Specific” Drug

BiDil Controversy Continues as FDA Approves First “Race-Specific” Drug

Is American health care ready for the first-ever drug targeted specifically to African Americans? On June 23, the U.S. Food and Drug Administration (FDA) approved BiDil® (isosorbide dinitrate/hydralazine hydrochloride), manufactured by NitroMed, Inc., for the treatment of heart failure in black patients. The approval was based primarily on the dramatic results of the 2001-2004 African American Heart Failure Trial (A-HeFT), an all-black clinical trial which found that patients taking BiDil experienced a 39% reduction in the rate of first hospitalization for heart failure and a 43% increase in survival rates.

“In BiDil, we now have a new treatment that has been shown to save the lives of black heart failure patients,” says the A-HeFT study’s lead investigator, Anne Taylor, MD, associate dean and professor of medicine at the University of Minnesota Medical School. “African Americans between the ages of 45 and 64 are 2.5 times more likely to die prematurely from heart failure than their non-black counterparts, and they also present with and die from the disease at an earlier age. FDA approval of BiDil represents an important leap forward in addressing this health disparity.”

However, as previously reported in MN (“What Color Is Your Treatment?” Winter 2004), some members of the medical and scientific communities continue to be uncomfortable with the idea of a “race-specific” drug. At a joint press conference on June 15, several key physician, research and civil rights groups, including the National Minority Health Month Foundation and the Association of Black Cardiologists, endorsed FDA approval of BiDil but expressed concern that characterizing BiDil as a “drug for blacks” could unfairly exclude other patients who could also benefit from the treatment.

“It would be ‘bad science’ to label or market this drug as a ‘black’ drug,” argued Dr. Gail Christopher of the Joint Center for Political and Economic Studies. “Race-based claims are not credible in the face of modern genetic science.” Dr. Randall Maxey, president of the Alliance of Minority Medical Associations, cited the need for further testing of BiDil across a broader range of ethnicities, because “the A-HeFT researchers do not assert that all black heart failure patients will benefit from BiDil, or that it is not effective in other population groups that can be categorized by social race.”