Hematologists and Oncologists are highly trained subspecialists of Internal Medicine with special expertise in the diagnosis and treatment of malignant diseases. In the US, Hematology emerged as a separate medical discipline from an organizational meeting convened on April 7, 1957 at Boston’s Harvard Club with 150 physicians in attendance. The first American Society of Hematology (ASH) meeting took place in April 1958, and the American Board of Internal Medicine (ABIM) held its first certifying examination in 1972 when 374 physicians became Diplomates in Hematology [566]. Medical Oncology became a subspecialty of Internal Medicine in 1972, and the first certifying examination was offered in 1973, with the first 351 Oncology diplomas being issued that year.

Board Certified doctors voluntarily meet additional standards beyond basic licensing. They demonstrate their expertise by earning Board Certification through one of the 24 Member Boards that are part of the not-for-profit American Board of Medical Specialties (ABMS). Before a doctor can become Board Certified, each must complete: four years of premedical education in a college or university, a course of study leading to an MD or DO degree from a qualified medical school, and three to five years of full-time experience in an accredited residency training program [567].

The ABIM, one of 24 member Boards of the ABMS, administers Board certification in all Medical specialties in the US (20 in 2012) and sets detailed “Policies and Procedures for Certification”, including rules for disciplinary actions, revocation of certification, and other issues [568]. Only physicians certified in Internal Medicine can apply for certification in a Medical subspecialty such as Medical Oncology or Hematology, which require an additional 24–36 months of training in an approved post-graduate program. As of February 5, 2013, the ABIM had issued 254,929 certificates in Internal Medicine, 8,967 in Hematology, and 14,158 in Medical Oncology. The passing rate in 2012 was 85 %, 86 %, and 90 %, respectively. A number of these individuals obtain certification in both Hematology and Medical Oncology. Both subspecialties have evolved considerably since their inception. At present, Medical Oncology is strongly entrenched in the diagnosis and treatment of cancer, particularly the delivery of cancer chemotherapy. Oncologists have become the focal point for the management of cancer patients, often coordinating the input of Radiation and Surgical Oncologists, and of other members of the interdisciplinary cancer treatment team. Likewise, Hematology has evolved from a discipline initially dedicated to benign blood diseases and coagulation disorders to one that increasingly focuses on transplantation, genetics, and cellular transduction medicine at one end, and merges with Medical Oncology at the other. In the practice setting, Hematologists, Oncologists, and Hematology-Oncologists manage the vast majority of advanced cancers in the US, and derive most of their income from administering chemotherapy rather than from cognitive services. Given the overlap in training requirements, and the convergence of Oncology and Hematology with regards to cancer diagnosis and treatment, the term Oncologists will hereafter refer to all physicians whose primary clinical focus is cancer, whether their original training was primarily Oncology, Hematology, or both. Because of their well-organized and strictly supervised training in all aspects of cancer, American Oncologists are, at the outset, highly competent physicians superbly qualified to diagnose and treat all cancer types. Most update their knowledge database and clinical skills on a regular basis through Continuing Medical Education and periodic re-certification.

Cancer specialists update their knowledge database, as part of an ongoing and even compulsory continuing medical education process, through formal and informal channels. These include: oncology journals and books addressing the broadest range of subjects; national meetings organized annually by cancer societies offering diverse professional activities ranging from carefully prepared educational sessions to reports of bench and clinical research; and national or regional seminars focused on specific cancer issues. Of the numerous journals addressing cancer that make at least part of their content available on-line, the highly respected biweekly Journal of Clinical Oncology alone contributed 4,589 pages to its subscriber’s bookshelves in 2,012, mostly of clinical trial reports with many appearing online before print. Likewise, Blood, the official ASH journal, published 5,252 pages of hematology and oncology articles in 2012, ranging from single case reports, to clinical trials, to immunobiology, to gene therapy. Additionally, a substantial number of single- and multi-authored books addressing a wide variety of cancer subjects are published with regularity. The former are usually theme-driven and are usually neither tutorial nor updated, whereas the latter are didactic with periodic updates. Some multi-authored books are part of multi-volume series with a broad range of subjects that are published over many years. Perhaps the best known and respected book, titled Cancer: Principles and Practice of Oncology, by DeVita and associates, now in its 9th edition, compiles 2,800 pages organized in 181 didactic chapters, written by numerous authoritative contributors [569]. Additionally, Oncologists have the opportunity to attend a variety of scientific meetings, seminars, and conferences that range from the highly informative and updated organized by cancer societies, universities, or research centers, to conferences of variable content and quality held by local oncology groups, often assisted by one or more guest speakers sponsored by the pharmaceutical industry. ASCO is one of the cancer societies with the greatest impact on Medical Oncologists, mostly through its yearly spring meeting. ASCO’s 2013 meeting was attended by 25,500 professionals, mostly physicians (46 %), eager to learn the results of a variety of ongoing clinical cancer trials directly from the very investigators conducting the trials, and to gage the direction of cancer research [570]. Forty seven percent of attendees were from the US, with the balance from 116 countries. Specialties most represented included Medical Oncology (24 %), Internal Medicine (16 %), and Hematology (9 %). At the 2013 ASCO meeting, 2,720 eclectic reports were chosen for presentation out of the more than 5,306 that competed for the spotlight, 61 % of which reported on clinical trials [571]. Another group with great influence on providers of cancer care is the ASH. As of 2010, the ASH had 14,212 members, of which 34 % are from overseas. The ASH’s 2012 annual fall meeting was attended by 20,578 scientists, clinicians, and guests to participate in a well organized program that included oral and poster presentations, a substantial portion of which addressed clinical issues and reported results of clinical trials, an educational program, and corporate-sponsored symposia. Because of ASCO’s and ASH’s large constituencies and broad reach, most of the nation’s basic science and clinical cancer research is reported at one or the other of these societies’ meetings. Attendance at one or both of the meetings each year by the vast majority of American Oncologists suggests the enormous influence these societies exert on continuing medical education and on the practice and direction of cancer care. This bewildering array of broadly disseminated scientific information, addressing everything from the broadest of issues to the narrowest of subjects on cancer, constitutes a source of continuing medical education widely utilized by most cancer care providers.

Finally, the interplay among Oncologists sharing an academic or community practice is a frequent source of exchange of information. Depending on the level and location of practice, this interplay can be informal or take place in one of two more formal settings: case discussions and journal clubs. As the name suggests, case discussions involve selecting individual cases for presentation to the group based on their didactic value or to seek a consensus regarding an uncertain diagnosis or a difficult management problem. Typically, in an academic center, case discussions are held weekly at the institution, and involve Medical, Surgical, and Radiation Oncologists, as well as Pathologists, Cytogeneticists, Flow Cytometrists, and other members of the medical team involved in patient care. On the other hand, the purpose of journal clubs is to review recent medical literature, focusing on a single subject. More informal and with the dual purpose of learning and socializing, journal clubs are often held monthly, usually at the home of each group member on a rotational basis. Finally, a variant of the journal club format involves oral presentations, frequently held in a restaurant setting, by remunerated speakers selected and sponsored by pharmaceutical companies based on both their experience and familiarity with one or more of the company’s drugs and their willingness to serve on its speaker’s panel. Here, the level of speakers’ expertise and the quality and objectivity of the information presented varies greatly. In fact, by exalting the benefits of the promoted drug and building goodwill towards the manufacturer hosting the meeting, such speakers serve the company’s goals more than the audience’s needs.

Hence, the evidence shows that, if the War on Cancer remains stagnant, it is due not to Oncologists’ faulty training or lack of expertise but to multiple extrinsic factors that directly or indirectly impact their practice, as we explore below.

Standard of care is primarily a legal concept that refers to the level of practice that any average, prudent, and reasonable physician would provide under similar circumstances of disease, time, and place. It must reflect the art (consensus of opinion) and the science (peer-reviewed literature) of medicine. In essence, from a legal standpoint, standard of care is not necessarily the best, most expensive, or most technologically advanced care available, but one that is considered acceptable and adequate under similar circumstances. Thus, providing treatment that is inferior to the norm and under- or over-utilizes medical services is unacceptable, unethical, and renders the physician liable to malpractice suits. Under these circumstances, and notwithstanding physicians’ assertions to the contrary, standard of care determines to a large extent medical practice in the United States. To the Oncologist, standard of care acquires the additional connotation of being the “best” treatment modality for a particular cancer. This conceptual evolution led to the current design of phase III clinical trials where an experimental drug is compared to the standard or “best” treatment regimen for the particular cancer under study. Based on clinical trials, an ever evolving standard of care for every cancer is promulgated or implied in medical publications, at cancer society meetings, and at national and local seminars and conferences, all reinforced by a legion of guest speakers sponsored by the pharmaceutical industry, coordinated and supported by their field representatives, who eagerly distribute copies of the pertinent articles praising the advantages of drug(s) in question. Because negative reports are seldom published, the vast majority of the information conveyed describes “progress”, “improvements”, and “advances” in cancer management, along with the subliminal message that cancer management is choosing between two or more drugs or drug combinations, rather than whether the potential benefits justify the risks. Under these circumstances, substantial departures from standard of care practice, including withholding either an inefficacious drug or a treatment of widespread use elsewhere, could be construed as negligence and malpractice.

When applied to malignancies amenable to cures or 5-year DFS in substantial patient subsets such as Hodgkin’s disease, testicular cancer, and a few other cancers, standard of care has profound practical and ethical implications. Indeed, in such cases, the benefit to risk ratio is dramatically shifted towards benefit, thus justifying a relatively high degree of risk to achieve a distinctly favorable outcome. Ironically, risks associated with such treatments are generally no greater than those linked to inefficacious regimens, with the notorious exception of acute leukemia, for which a complete ablation of patients’ bone marrow, a prerequisite to achieving complete remissions and some cures, contributes to serious complications, including deadly infections, more often than to cures. In contrast, when applied to non-curative regimens that do not prolong survival meaningfully, standard of care essentially means “the best” of a group of fundamentally inefficacious therapies, a highly dubious honor. Yet, many cancer drugs and treatment regimens shown to be inefficacious over the years remain in use today because, in the absence of better alternatives, they are considered standard of care. For instance, a 2000 review of two decades of chemotherapy experience in the treatment of advanced non-small cell lung cancer by the ECOG reported an average tumor response rate of 25 %, a median survival of 25 weeks with 20 % surviving 1 year, regardless of the drugs or drug combinations used [575]. Based on these rather meager results, the author concluded, “It is appropriate to offer chemotherapy to all NSCLC patients with advanced disease, a good performance status, and no medical or psychological contraindications to its use”. Recommendations such as this, made by leading experts in their field, especially when published in high-profile medical journals, are uncritically embraced by community Oncologists as the standard of care for day-to-day patient management.

Standard of care is also shaped by an unending barrage of clinical trial reports, particularly Phase III trials, each describing the merits and advantages of a drug or drug combination over alternatives for treating a particular cancer, enticing practitioners to “follow the lead”. However, given the marginal efficacy of cancer drugs, many phase III clinical trials yield statistically significant differences in outcome with no clinical relevance, a concept few clinicians understand [576]. Rather than definitive, results from such studies should be viewed as exploratory and a springboard towards definitive studies. Oncologists’ tendency to apply results of the latest clinical trials to their day-to-day practice is exemplified by the saga of the chemotherapy regimen known by its acronym “CHOP” (Cyclophosphamide, Hydroxydoxorubicin, Oncovin, and Prednisone), a drug combination that, developed in the early 1970s, became the treatment of choice for diffuse large B-cell lymphoma. Despite CHOP’s superior efficacy, many alternative regimens were proposed and studied, including those known by the acronyms COMLA, ESAP, MACOP-B, m-BACOP, PROMACE-CYTABOM, and VACOP-B. Over the years, many patients were treated with these drug combinations and, despite some claimed advantages, the average outcome was inferior to CHOP’s. More recently, CHOP has been combined with other agents with varied results. For instance, CHOP plus Rituximab for lymphoma was reported to “significantly increase the rate of complete responses, decrease the rates of treatment failure and relapse, and improve event-free and OS as compared with standard CHOP alone” [577]. Yet, a companion editorial cautioned, “the difference between the survival curves begins to shrink at 2.5 years….it is of concern that more patients treated with CHOP plus rituximab died from infection, cachexia, or cardiac disease” [578]. Nevertheless, CHOP remains a useful regimen for the treatment of certain forms of non-Hodgkin’s lymphomas. Reports of some clinical trials reveal a therapeutic advantage for a small subset of study participants discovered after much statistical data triage, rather than for the majority, as anticipated. In general, such trials should be considered negative and published only if the mined data establishes a new standard of care for the patient subset.

With very few exceptions, the outcome of an office visit is a prescription for medications, for laboratory tests, an imaging procedure, or a referral. In most cases, physicians have no financial interest in the pharmacy filling the prescription or in the facilities performing the procedures, and kickbacks are virtually unheard of, thus averting major conflicts of interest. Yet, in the United States, most health care is based on fee-for-service, which impacts physicians’ practices as underlined by the very existence of incentive programs implemented by drug companies and health maintenance organizations [579, 580], a phenomenon well-documented in reports of over-utilization of services, especially those owned by physicians [581]. Over-utilization of services by physician-owners of equipment adds another source of income generation for medical practices [582, 583]. This has been amply documented in a very large retrospective analysis of an insurance claims database conducted on 526,000,000 diagnostic medical imaging claims between 1999 and 2003 that included the specialty of provider and referring physicians. Analysis of 18,123,121 episodes of care revealed,

Physicians who referred patients to themselves or to other same-specialty physicians for diagnostic imaging used imaging between 1.12 and 2.29 times as often, per episode of care, as physicians who referred patients to radiologists (P < .005 for all comparisons). Adjusting for patient age and comorbidity, the likelihood of imaging was 1.196–3.228 times greater for patients cared for by same-specialty–referring physicians…These findings were consistent across the eight combinations of conditions and imaging procedures evaluated and cannot be explained by differences in case mix, patient age, or comorbidity [584].

In cancer care, the profit motive of many diagnostic and therapeutic decisions is obvious, ubiquitous, and hard to escape. Profit-driven practices are typified by over-utilization of standard services, by offering non-essential though convenient services, but first and foremost by the chemotherapy concession. Oncologists’ tendency to offer additional income-generating services within the office is well-documented. For instance, the National Practice Benchmark 2010 report, derived from 117 Oncology practice responders nationwide, reported,

Nearly all of the reporting practices provide medical oncology and hematology services; three quarters of the respondents offer laboratory services and clinical research; and a third of the practices provide imaging, a closed-door pharmacy, genetic counseling, and radiation oncology services [585].

However, the most lucrative source of revenue for most Oncologists is the Chemotherapy Concession, also called “The Buy-and-Bill” model, which refers to the sale of chemotherapy drugs from doctors’ offices [586]. This unique practice has been an economic reality for more than 30 years and accounts for two thirds of the income of Oncologists in private practice [587]. As could be expected, there are sound rational justifications for such a modus operandi, even if it raises serious ethical issues and often results in practices ranging from questionable to borderline unethical. The origins of the Chemotherapy Concession was the decision by Oncologists in private practice to combine delivery of cognitive and drug delivery services at their offices. This decision was professionally sound, given its convenience to themselves and their patients, and its many advantages. The most obvious benefits include: stocking on site most chemotherapy drugs common to a practice; minimizing the risk of errors in administration (intravenous medications are mixed and delivered by trained nurses); presence on the premises of the prescribing Oncologist (or an experienced nurse) to respond to any drug reaction or unforeseen treatment complication; and providing cancer patients a convenient and soothing environment where they can share experiences and support one another. That decision was also very astute financially. Indeed, Oncologists purchase drugs in bulk, at discount prices, from wholesalers, and sell them to patients one by one and at retail prices. Drug price markups, which range between 10 or 20 % to as high as 200 %, have been justified to cover overhead costs and to amortize chemotherapy facilities. Although such a practice is not in itself unethical, the opportunity for financial rewards from choice of drugs and practice patterns create conflicts of interest.

Oncologist compensation can be ascertained from a 2012 survey of 24,216 US physicians across 25 specialties [588]. After excluding “expert witness services, speaking engagements, and product sales”, responding Oncologists’ mean compensation was $295,000, with 15 % earning less than $100,000 but 10 % earning $500,000 or more. Oncologists in multispecialty group practices earned the most ($347,000), while those in academic settings earned the least ($164,000). The majority of Oncologists (56 %) spent an average 13–20 min with each patient, whereas 10 % spent less than 12 min and 33 % spent more than 21 min. The impact of non-cognitive services on Oncologists’ income can be enormous [589]. Indeed, 117 Hematology/Oncology practices responding to a recent survey, including approximately 30 % who offered imaging and closed-door pharmacy, provide a window on current Oncology practice and income. Approximately 3,500 patients per FTE¹ were seen annually, and 90 % of practices sold drugs through the traditional Buy-and-Bill system, using an average 11 chairs per practice to administer an average 1,000 infusions per FTE. Average total income per FTE (gross revenue minus operating expenses) from 37 practices was approximately $1 million, including approximately $250,000 from imaging services, $60,000 from laboratory services, and $30,000 from closed-door pharmacy. Medicare was the main payer (46 %) [590]. Surprisingly, despite being in the top 10 best-remunerated specialties, 49 % of private Oncologists feel undercompensated [591]. In contrast, academic Oncologists’ incomes are based solely on collections from charges for the time-consuming but less lucrative cognitive services: i.e., office visits, consultations, and the like. In academia, profits from drug sales are credited to the hospital pharmacy and receipts from laboratory tests are credited to the hospital laboratory. In addition, the demographics of patients attracted by private and academic Oncology practices have a major financial impact: The former is patronized by patients who, through insurance or their own funds, pay their full share of their health care costs, whereas academic Oncology practices accept and therefore attract indigent and low-income patients seeking health care subsidized by the state or the institution. Thus, because a large portion of charges at academic centers are non-collectable and some of the rest are lost to unsound accounting practices, collection rates by academic Oncologists can be as low as 20 % (20 cents collected for each $1.00 charged), whereas they reach 95 % in tightly-run private Oncology practices. While income discrepancies between private and academic practices are unjustified from knowledge and workload standpoints, the profit motive is so ingrained into healthcare that some proponents of equalization yearn to “Make the practice profitable…[by] maximizing the clinical revenue from each patient” [592] and that “It is critical [for hematology and medical oncology divisions] to acquire access to infusion center profits” [593].

While abuses of the chemotherapy concession are not rampant, there are countless circumstances and opportunities for engaging in subtle practices that base treatment decisions on financial considerations. Examples include: using CSF and erythropoietin outside of recommended ASCO indication guidelines [594]; selecting intravenous rather than oral cancer drugs of comparable efficacy; newer and more profitable but not necessarily more efficacious drugs; drug regimens that require more frequent office visits; or embracing highly profitable though unproven cancer management approaches, as was the choice of high-dose chemotherapy with stem cell rescue as the preferred treatment for some cancers without evidence-based support of its benefits [595]. While pressures from patients, patient advocates, and policymakers played crucial roles in the premature adoption of bone marrow transplantation, private and academic transplanters were quick to oblige. Universities, cancer centers, and large private practices scrambled to offer transplanting services, less to improve or complement their existing programs than as an income-generating procedure that eventually proved no better than standard chemotherapy for breast cancer, its major indication at the time. However, notwithstanding the ethical implications of the chemotherapy concession and its potential abuse, perhaps the most questionable Medical Oncology practice, adhered to by most private and academic Oncologists, is the administration of chemotherapy to patients with advanced cancers historically proven not amenable to cures or survival prolongation and to do so through the end of life. The sequence begins with “first line” drugs or drug combinations that historically have elicited the best tumor responses. Unresponsive patients and those whose cancer relapses after an initial response are then treated with “second line” regimens that, as the name suggests, are generally less inefficacious but equally toxic. Ultimately, most patients are treated with “salvage” therapies, a euphemism with little practical meaning. Finally, from time to time, Oncologists witness unexpected long-term survivors among patients expected to succumb to progressive cancers regardless of treatment. Such cases tend to be more vividly remembered than those who died of their disease within the anticipated time frame, tempting the physician to treat comparable future patients similarly. Though well-intentioned, such treatment decisions allow emotions to prevail over good judgment and unnecessarily expose patients to additional chemotherapy-induced side effects in an attempt to recreate a few memorable, though unexplained, outcomes.