  Over the past 20 years, advances in cancer treatment have created a new challenge: How does medicine meet the needs of increasing numbers of patients who survive the disease? Thanks to earlier detection and more effective therapies, roughly 14 million cancer survivors are now living in the United States, with this population expected to reach 18 million by 2020.

The challenges of survivorship were first spotlighted in the 2005 Institute of Medicine (IOM) report, 

From Cancer Patient to Cancer Survivor: Lost in Transition

 The study estimated that 10 million cancer survivors were then alive in the United States; that number had tripled complex physical and psychosocial conditions. The study found primary care physicians (PCPs) seldom received explicit guidance from oncologists for survivors in remission and lacked evidence-based best practices.

A 2012 report on survivorship published by the American Cancer Society (ACS)

 estimated 13.7 million Americans with a history of cancer were alive on January 1, 2012, and nearly 18 million will be alive January 1, 2022. Prostate cancer is the most common diagnosis for men; at 43% of all cancers for men it is almost 3 times as common as the next 2 diagnoses combined, which are colorectal (9%) and melanoma of the skin (7%). Similarly for women, breast cancer at 41% is more than twice as common as uterine corpus (8%) and colorectal (8%) cases combined.

The 2012 ACS report concluded, “It is increasingly important to understand the unique medical and psychosocial needs of survivors and be aware of resources that can assist patients, caregivers, and health care providers in navigating the various phases of cancer survivorship.”

“We are going from the Big C, that automatically killed people and we couldn’t do much about it, to cancer as a chronic disease or a disease we can cure. It is still scary, but it is not the automatic death sentence it once was,’’ said Crystal Denlinger, MD, an oncologist at Fox Chase Cancer Center in Philadelphia, Pennsylvania. Denlinger, who specializes in treating gastrointestinal cancers, chaired the National Comprehensive Cancer Network (NCCN) panel on survivorship guidelines and coauthored their publication in the Journal of the National Comprehensive Cancer Network in May 2013.

 A patient-friendly version now appears on the NCCN website

“We are getting better at what we are doing, but we were all focused on treating the cancer and not the fallout of the treatment,” she said.

The NCCN guidelines for cancer survivorship planning and care are intended for both oncologists and PCPs treating cancer survivors. The algorithms in the guidelines make recommendations for addressing anxiety and depression, cognitive function, exercise, fatigue, immunizations and infections, pain, sexual function, and sleep disorders in patients who have survived breast cancer, chronic myelogenous leukemia (CML), colon cancer, Hodgkin lymphoma, melanoma, non-Hodgkin lymphomas, non-small cell lung cancer (NSCLC), prostate cancer in 30 years. About two-thirds, or more than 6 million people, were older than 65 years.

A large percentage of survivors, particularly those who are older, suffer chronic conditions in addition to cancer. The IOM report detailed systemic shortcomings in coordinating the nation’s notoriously uncoordinated healthcare system to provide cancer care for aging patients with cancer, small cell lung cancer, and thyroid carcinoma.

 Denlinger said the guidelines will help care providers fulfill a crucial recommendation from the 2005 IOM report: each cancer patient should receive a “survivorship care plan” that includes diagnosis and content of followup visits, tips on maintaining a healthy lifestyle and preventing recurrent or new cancers, legal rights affecting employment and insurance, and the availability of psychological and support services.

“The survivorship care plan that delineates what is required for follow-up has gained a lot of traction,’’ she said. “A lot of people are struggling with how to put together these care plans when, for many patients, the information is scattered across multiple offices and multiple systems.’’

The Commission on Cancer, which certifies most US cancer care centers, has made survivorship care plans a certification requirement beginning in 2015.

 “A few decades ago, a patient surviving cancer 5 years was a success,but now people are surviving longer and longer,” said Sarah R. Arvey, PhD, director of Research and Evaluation at the LIVESTRONG Foundation in Austin, Texas. “Once treatment is completed, patients and the primary care physicians should receive a list of what happened to you in the hospital, and the known risks of those medicines and treatments. You need to walk out of there with a plan. With electronic medical records this will become easier.’’

LIVESTRONG has developed a survivorship care planning template that, along with templates from the American Society of Clinical Oncology (ASCO) and National Coalition for Cancer Survivorship, is recommended in the new survivorship care plan requirement.

Survivorship planning and care is rising as a priority, because the transition from a fee-for-service reimbursement system to an accountable care system demands increasing correlation between results and what gets paid for, said Bo Gamble, director of strategic practice initiatives for the Community Oncology Alliance (COA).

“Healthcare is the last industry without metrics to determine what is good care or not such good care,’’ Gamble said. “We’ve seen a mass exodus of oncologists from community practice to hospitals, mainly for reasons of reimbursement. Patients and their insurers are paying almost double for hospital care. We want to develop the measures to make valid comparisons and create some healthy competition to improve care.’’

In 2012, Gamble and COA launched the Oncology Medical Home Initiative to explore with medical providers and payers what constitutes quality cancer care. He reports a high level of agreement and strong commitment to developing survivorship as part of standard care. “We asked the question, ‘What do you need in cancer care?’ The answer from everybody is the best quality care at the least cost with a good survivorship program that includes quality of life,’’ Gamble said.

“Payers, providers, patients, everyone answered the same. The payers said—and this was profound&mdash;they don’t want to give the impression (they) are about withholding care.’’

In fact, when Gamble detailed COA’s effort to develop 19 standards of cancer on October 30, 2013, at the meeting Value-Based Oncology Management in Chicago, Illinois, he noted that payers were the first to ask that survivorship be included in the standards.

Ira Klein, MD, chief of staff to the chief medical officer for Aetna and active in the Oncology Medical Home Initiative, said survivorship programs will succeed by empowering patients with  information they can both understand and apply, while providing metrics for evaluating the costs and benefits of various treatments.

“We are looking for where what makes the most sense financially is what’s best for the patient. We want to arrange things so we encourage health, because being healthiest is what is cheapest, and when we have illness we pay for what works and not just everything people do,’’ Klein said.

“As we move from the very individualistic model of health care to population health care, the people who pay for the service recognize continuity of care is important,’’ he continued. “Once cancer patients are in remission they need a navigator to help with selfmanagement, help organizing records of their treatment, access to information on how to improve their health, how to manage long-term side effects. Maybe anxiety and depression will be issues; they may still be obese; they may not exercise and still smoke.’’ Dexter Shurney, MD, is chief medical director for Cummins, Inc, a leading global corporation headquartered in Columbus, Indiana, designing, manufacturing, selling, and servicing diesel engines and related technology. The company’s healthcare system covers 110,000 people and is about equally divided between employees and their families, Shurney said. The company is lending its perspective to the Oncology Medical Home Initiative because it already follows that mode for coordinated primary and cardiac care.

“We have a lifestyle approach to primary and cardiac care that encourages wellness. We know foods that contribute to heart disease contribute to obesity and diabetes,’’ Shurney said. “We would expect the oncologists to have a lifestyle approach to survivorship, particularly making sure patients don’t get a second cancer or it is caught early if they do. Our population will include children, some very young who require long-term follow up, and employees who want to get back to work as much we want them back. “Once people are in remission, what are the lifestyle adoptions they need to make? That is the conversation we are looking to measure, to see if that haphappens,” he said. “We don’t want people discharged without looking at what they might be doing that contributed to their cancer.’’

Lack of information is not the obstacle to writing a survivorship care plan. The biggest barriers are logistical and institutional; they include the technical challenge of coordinating the specifics of patient treatment with established best practices and documented side effects of medicines and treatment, and then paying care providers for it. “There is no reimbursement for putting together a plan the patient can take away. ... Physicians aren’t paid for it, so it just doesn’t happen,’’ said Shelley Fuld Nasso, chief executive officer of the National Coalition for Cancer

Survivorship. “For this to be common practice, we have to compensate physicians for their time.’’

Avery, of LIVESTRONG, said it takes about 3 hours per patient to assemble their survivorship care plan. “How can you get this done and get reimbursed for it?’’ she asked. “We have tools, the jewel being our free patient navigation services. We can help cancer clinics meet the needs of survivors.”

Nasso pointed to Journey Forward, a project to integrate data from cancer registries to speed plan preparation for 2 audiences, the patient and the primary care physician (PCP) who will care for the survivor once the cancer is in remission. “We need the NCCN guidelines to reach primary care physicians who are treating cancer survivors, and we need patients to get something, understandable to them, that says, ‘This is what you are facing; these are the side effects you should expect; this is when you need to call us,’’’ Nasso said. “I think it will get easier to create survivorship care plans as electronic record keeping improves.’’

In 1959 the British Medical Journal published a study that found cancer patients did better when doctors told them the truth about their diagnosis.

 Today, cancer is not always the disease doctors sometimes hide from doomed patients, but, even with better results from oncology, it remains perhaps the most dreaded diagnosis. A new IOM report issued this year, 

Delivering High Quality Cancer Care: Charting a New Course for a System in Crisis

 tempers optimism nurtured by increasingly effective treatments. The nation can anticipate 1.6 million new cancer cases annually with more than half striking people older than 65 years, with comorbidities common in this population. Treatment, already costly, is skyrocketing with each new therapy. The 2013 IOM report found that living with cancer is frequently grueling mentally, emotionally, and financially for patients and their families.

Screening programs have led to more overdiagnosis than cures while encouraging overtreatment of patients faced with bewildering and scary choices.

 For all the progress, cancer will likely surpass heart disease as the nation’s leading cause of death this decade.

  “We are in a new payment environment that presents a great opportunity to raise the quality floor,’’ said Amy Berman, a senior program officer at the John A. Hartford Foundation. Her focus is on the health and healthcare of older adults, evaluating both the cost and effectiveness of care.

Berman has become her own best case study. Three years ago she was diagnosed with stage IV inflammatory breast cancer. The first oncologist she consulted recommended aggressive treatment including surgery, chemotherapy, and radiation that he conceded would not cure her. She declined, pursued palliative care, and remains at her job. During her keynote address in Baltimore, Maryland, at Patient-Centered Oncology Care 2013, sponsored by 

, Berman told a rapt audience about visiting the Great Wall of China and staying active as an advocate for palliative care.

The NCCN survivorship guidelines are a good start, she said, toward a frank discussion about what outcomes survivors can expect in exchange for the misery and cost of cancer treatment. She cites research that found patients who received palliative care frequently had better outcomes with standard treatment than patients who did not.

“People need an open conversation about the likely course of the disease,not just their diagnosis,’’ she said. “My prognosis, the likely course of my disease, is that about 11% of people live 5 years. What do I want my next couple of years to look like and feel like? A curative approach that doesn’t cure will take away time from my family, cause me pain, and put me in the hospital where I am exposed to other infection.

“I take medications with the least side effects to hold the cancer at bay and, 3 years out, I feel great, I’ve saved about $500,000 and I have a great life,” Berman said. “But if I hadn’t understood the likely course of this disease, I might have thrown everything at it.’’

1. Siegel R, DeSantis C, Virgo K, et al. Cancer treatment and survivorship statistics, 2012. CA Cancer J Clin. 2012;62(4):220-241.

2. Institute of Medicine. From cancer patient to cancer survivor: lost in transition. http://www.iom.edu/Reports/2005/From-Cancer-Patient-to-Cancer-Survivor-Lost-in-Transition.aspx Published November 3, 2005. Accessed November 18, 2013.

3. American Cancer Society. Cancer Treatment and Survivorship Facts and Figures, 2012-13. Atlanta: ACS; 2012. http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-033876.pdf. Accessed November 2, 2013.

4. Ligibel JA, Denlinger CS. New NCCN guidelines for survivorship care. J Natl Compr Canc Netw. 2013;11(5 Suppl):640-644.

5. National Comprehensive Cancer Network. DFCI/NCCN Cancer Survivorship Information. http://www.nccn.org/professionals/survivorship/default.asp. Accessed December 2, 2013.

6. American College of Surgeons. Commission on Cancer, Cancer Program Standards 2012:Ensuring patient-centered care, continuum of care services. http://www.facs.org/cancer/coc/programstandards2012.pdf. Accessed November 24, 2013.

7. Aitken-Swan, J, Easson, EC. Reactions of cancer patients on being told their diagnosis. Br Med J. 1959;1(5124). Accessed November 20, 2013.

8. Levit L, Balogh E, Ganz, PA. Delivering high quality cancer care: charting a new course for a system in crisis, a report of the Institute of Medicine. Washington, DC: National Academies Press. http://www.nap.edu/catalog.php?record_id=18359. Published 2013. Accessed December 2, 2013.

9. Esserman LJ, Thompson IM, Reid B. Overdiagnosis and overtreatment in cancer: an opportunity for Improvement. JAMA. 2013;310(8):797-798.

10. Ganz, PA. Survivorship: adult cancer survivors. Prim Care. 2009;36(4):721-741. 11. Temel JS, Greer JA, Muzikansky A, et al. Palliative care for patients with metastatic non—small-cell lung cancer. N Engl J Med.soo 2010;363:733-742.

Articles

Evidence-Based Oncology

The Quest for Better Survivorship: Guidelines Promote More Accountable Cancer Care

The word “landmark’’ is not in the title, and strictly speaking it is not the Surgeon General’s report but that of an advisory committee to US Surgeon General Luther Terry. Yet “the landmark 1964 Surgeon General’s report’’ is shorthand for the document that would change America’s mind about cigarettes, and, in time, the habit of smoking.

“It was a big deal,” Tom Glynn, 66, senior director of cancer science and trends for the American Cancer Society, said of the report, which is approaching the 50-year anniversary of its release on January 11, 1964.

 Glynn grew up in a New York City apartment where both parents smoked and his grandfather puffed a pipe. His father died of lung cancer.

“I remember clearly it got a lot of news ... 1964 was the highpoint, depending on your point of view, for smoking in the United States. Most people don’t remember, but if you sat in a movie theater, people smoked next to you. People smoked on airplanes; homes were filled with smoke.’’

As the advisory committee worked feverishly for most of 1963 to prepare the report, the nation’s cigarette consumption per capita peaked at 4345, having risen steadily for decades from just 54 in 1900.

 What Terry referred to in his foreword as the “tobacco-health controversy,’’ the decades-long lockstep increase in cigarette consumption and lung cancer, was officially unresolved in the view of the US Public Health Service, but Terry was determined that it would be. “The subject does not lend itself to easy answers. Nonetheless, is has been increasingly apparent that answers must be found,’’ he wrote.

Smoking and Health: Report of the Advisory Committee to the Surgeon General of the Public Health Service, 

 on a Saturday, timed to roil the Sunday newspapers but not the stock market. The committee’s conclusion, that cigarette smoking causes lung cancer in men and probably women, and is among the causes of chronic bronchitis, resounded like a voice from

the sky. As Terry expected, headlines with the report’s findings blared across the Sunday papers, with 

 front page referring to the cigarette “peril” and “cancer link cited.”

“I remember debating the news with a group of teenagers the day it came out,’’ recalled Gregory N. Connolly, 64, director for the Center for Global Tobacco Control and professor at the Harvard School of Public Health. “My father eventually quit smoking. The report was a transfer of science to the public that touched every individual.’’

While the report was a thunderous end to the official uncertainty about whether smoking is unhealthy, its conclusions were not an abrupt departure from medical opinion. In the neutral language of a government report, the committee outlined an unfolding shift in global public health opinion about smoking from studied to alarmed. The committee noted the 1962 report of the Royal College of Physicians in England, which stated, “Cigarette smoking is a cause of lung cancer and bronchitis and probably contributes to coronary heart disease and various other less common diseases.’’

By the time Terry appointed his advisory committee, the committee noted, the nations of Denmark, Italy, and Great Britain had banned or limited tobacco advertising. Those reports and actions abroad, along with a request from the Federal Trade Commission (FTC) on whether the science required that cigarettes carry a health warning, were among the reasons Terry listed for appointing the advisory committee. Beginning in the 1930s but accelerating through the 1950s, a mountainous body of research had accumulated correlating lung cancer with smoking cigarettes.

In 1956, then—surgeon general Leroy E. Burney appointed a scientific study group on smoking and health, drawing from the National Cancer Institute, the National Heart Institute and the American Heart Association, marking the Public Health Service’s first involvement in the question. Guided by the study group’s conclusion, Burney in 1957 published a statement declaring, “It is clear that there is an increasing and consistent body of evidence that excessive cigarette smoking is one of the causative factors in lung cancer.”

What constituted “excessive’’ Burney did not say, and he dropped the adjective in a second official statement in 1959, writing “the weight of evidence at present implicates smoking as the principal factor in the increased incidence of lung cancer.’’

In June 1961, a reevaluation of smoking and health was suggested by the American Cancer Society, the American Heart Association, The National Tuberculosis Association (later the American Lung Association) and the American Public Health Association in a letter to President John F. Kennedy.

The letter suggested that Kennedy appoint a committee to find “a solution to this public health problem that would interfere least with the freedom of industry or the happiness of individuals.’’

Terry invited representatives of those same organizations in June 1962

 to a meeting for “objective assessment of the nature and magnitude of the health hazards’’ of smoking after President Kennedy responded to their request for a committee.

“We are very proud, as an organization, that we were at the table at that meeting when it was agreed to make an objective assessment of the health effects of tobacco,’’ said Erika Sward,  assistant vice president of National Advocacy for the American Lung Association. “The 1964 Surgeon General report states very clearly that cigarette smoking is causally linked to lung cance in men, and they established it as the most important cause of chronic bronchitis and emphysema, which is now known as COPD (chronic obstructive pumonary disease). It was a landmark report, the first time there was a massive declaration by the federal government that tobacco use was becoming an epidemic.”

Terry appointed a committee of 10 eminent specialists, none with expertise in smoking, to work with a small staff and a wide range of consultants to evaluate the available research, draw conclusions, and make recommendations. “The committee’s assignment has been most difficult,’’ the Surgeon General wrote in his foreword, a statement bordering on understatement. Between November 1962 and publication in January 1964, the committee reviewed 7000 studies and consulted with more than 150 experts. The list of acknowledgments covers 9 pages of names.

The committee’s primary job was to determine if the enormous amount of evidence associating cigarette smoking with disease, particularly but not exclusively lung cancer, supported the conclusion that smoking “caused’’ the disease. The committee accepted the challenge, stating “statistical methods cannot establish proof of a causal relationship in an association. The causal significance of an association is a matter of judgment which goes beyond any statement of statistical probability.’’

The committee established 5 criteria for building a bridge from association to causation: (1) the consistency of the association; (2) the strength of the association; (3) the specificity of the association (4) the temporal relationship of the association; and (5) the coherence of the association. “Science at the time was looking at the mechanistic link,’’ said Connolly, of the Harvard School of Public Health.

“We wanted to know what in smoking triggered what cell in the lung so we could show cause. It was a very clinical perspective. This report really invented modern epidemiology, determining cause by looking at large population data.’’

The economic significance of the tobacco industry and the ubiquitous nature of smoking caused the committee to shroud its deliberations in secrecy. Most of its work was down deep in the National Library of Medicine (NLM). The import of the committee’s work soon became apparent to Don Shopland, who in the spring of 1962 was newly graduated from high school and beginning his first adult job at the NLM.

“There were locked files, administrative confidential files, that sort of thing,’’ said Shopland, who only months before had begun working at the library. Soon, he was working full time for the committee. In 1966, he joined the National Clearinghouse on Smoking and Health, and he later became director of the Office of Smoking and Health (OSH), where he helped write 20 more reports on smoking to Congress.

“There was constant tension around the work,’’ Shopland said. “We worked 7 days a week from August or September when I stared, for the rest of the year, often until midnight. I recall having off Christmas Day, Thanksgiving, and a half-day the day of Kennedy’s funeral. It was a very intense time.’’

The legendary investigative journalist, Drew Pearson, outlined in an October 1963 column the pressure on the committee, and the federal government’s lack of enthusiasm for regulating tobacco and smoking. Pearson correctly reported the committee would link smoking and cancer. He quoted US Secretary of Health, Education, and Welfare (HEW) Anthony Celebrezze, a pack-a-day smoker, who didn’t “consider it the proper role of the federal government to tell people to stop smoking.’’ Pearson cited concerns of the US Department of Agriculture on tobacco crop prices, as well as the FTC’s need for guidance on the need for warning labels and other regulatory issues.

“When we submitted the report to the government printing office, it was the only non-military report that was printed ‘Top Secret,’ ’’ Shopland said. “The tobacco companies were major industries, almost like General Motors. (The committee) took great pains to make sure nothing leaked out that would affect the stock market. They were afraid what would happen to the tobacco industry and related industries for paper, packaging, Wall Street. Tobacco reached deep into society.’’

As it turned out, the regulatory fallout from the 1964 report had little immediate effect on most smokers, with the per capita consumption remaining around 4000 cigarettes for another decade,

or on the industry, which remained profitable and politically potent. In June 1964, the FTC relied upon the surgeon general’s report to require health warnings on cigarettes while it considered restrictions on cigarette advertising.

 In 1965, Congress passed the Federal Cigarette Labeling and Advertising Act (which precluded any package warning except “Caution: Cigarette Smoking May Be Hazardous to Your Health.”) The law required the FTC to report annually on the effectiveness of the warning, and for HEW, of which the surgeon general was a part, to report annually to the Congress on the health consequences of smoking.

The Public Health Cigarette Smoking Act of 1969 banned cigarette advertising on television and radio, and the package label changed to the sterner “Warning: The Surgeon General Has Determined that Cigarette Smoking Is Dangerous to Your Health,’’ but precluded states and localities from regulating other forms of advertising such as billboards and promotions.

 The industry remained largely unregulated by the federal government

 until 2009, when President Barack Obama signed the Family Smoking Prevention and Tobacco Control Act that brought cigarettes under purview of the US Food and Drug Administration (FDA), although this groundwork was laid in 1996 by former FDA commissioner David Kessler, MD, a pediatrician.

“After the 1964 report Terry called for remedial action. What happened was Congress exempted tobacco from every health and safety law,’’ said Connolly of the Harvard School of Public Health.

One of the first studies to link cigarette smoking and cancer was coauthored in 1939 by Alton Ochsner, MD, founder of the famed Ochsner Clinic in New Orleans, Louisiana. Early on, Ochsner was ridiculed for his aggressive promotion of his findings, but he became one of the nation’s earliest advocates against cigarette smoking.

 Most in the medical profession did not see much harm in moderate cigarette use, and many doctors smoked themselves, a fact that the tobacco companies would use to their advantage as health concerns about cigarettes grew.

Tobacco companies courted physicians as soon as health concerns arose. One way was placing advertising in the 

Journal of the American Medical Association

 (JAMA), which accepted tobacco ads for 20 years starting in 1933.

 Eventually, tobacco companies used depictions of physicians in the ads themselves; “More doctors smoke Camels” became a classic. When research by Ochsner and others led to a December 1952 

 it caused a temporary dip in cigarette sales and an immediate response from both JAMA and the tobacco companies.

JAMA stopped accepting tobacco ads. But the industry formed the Tobacco Industry Research Committee (TIRC) to both award research grants and advance the industry’s position.

 Advertising strategy shifted from overt representation of doctors to the promotion of filtered or “safer” cigarettes, which were buoyed by their “studies” and Hollywood actresses who crowed that these new models were “just what the doctor ordered.”

The connections among Big Tobacco, the advertising industry, and physicians did not ebb overnight. Pushed by Ochsner, in 1952 the American Cancer Society began a long-term study to prove cigarettes caused cancer.20 JAMA published Ochsner’s findings and Burney’s 1959 statement on tobacco, but when necessary the industry simply bypassed this outlet and sent favorable study results directly to physicians. Big Tobacco was so entrenched in American culture that Ochsner was warned before an appearance on Meet the Press not to state that there was a causal link between cigarettes and lung cancer.

By 1964, as Smoking and Health rocked the country, the AMA seemed poised to issue a report on cigarette smoking and cancer. For 2 years, however, the physicians’ group had been fighting another battle: President Kennedy’s proposal to create Medicare. Although the AMA denied the charge, US Rep. Frank Thompson (D-NJ) and others accused the group of striking a deal with lawmakers from the tobacco states: if the AMA held its tongue on cigarettes, the legislators would fight Medicare.

On February 7, 1964, less than a month after the Surgeon General’s report was unveiled, the AMA accepted $10 million A Permanently Altered Landscape Knowledge of the dangers of cigarette smoking have seeped into the public consciousness to a degree unthinkable in 1964. This has allowed research priorities to shift as well, as studies turn to issues surrounding public education and health disparities; it is well documented that the effects of smoking hit hardest on low-income groups and the developing world.

 In fact, in October 2013, the American Thoracic Society and the European Respiratory Society published a statement in The American Journal of Respiratory Critical Care Medicine announcing the creation of a committee to address the fact that lower-level socioeconomic groups are 14 times more likely than higher-level groups to suffer from respiratory ailments, with cigarette smoking being a major reason.25

In recent decades, the AMA has joined with other medical groups to combat cigarette smoking, especially among the young. In September 2009, the AMA praised the FDA for a ban on flavored cigarettes, after numerous studies in which “the evidence shows that young smokers are the primary users of flavored tobacco products.”

Much of today’s policy focus is on stopping young people from picking up the habit; last month, the New York City Council raised to 21 the age at which it is legal to buy cigarettes.

Clinically, smoking still kills. The most recent data sheet from the Centers for Disease Control and Prevention (CDC), published August 1, 2013, states that 440,000 deaths, or 1 in 5 in the United States, are caused by smoking.28 This includes 90% of all deaths from COPD.28 Many were already smokers in their twenties when the 1964 report came out, who have been unable to quit, and now suffer its health effects in their old age.

The 1964 report was the first big step in a very long trek to a smoke-free society, said Glynn of the American Cancer Society, who is working on commemorating the 50th anniversary.

“I grew up in a small New York City apartment with 2 cigarette smokers and my grandfather smoking a pipe. No one thought a thing about it,’’ Glynn said. “We went from 42% of the population then (smoking) to 19% now. That is a huge public health success. Probably between 8 and 12 million lives have been saved since the publication of that report, but we still have 44 million people smoking, even though 70% of them say they want to stop. Our work remains to get people to stop smoking, period. I know that sounds obvious, but that’s the work, still.’’

from tobacco companies, which it would combine with $500,000 of its own funds for research grants. Ochsner publicly called the AMA “derelict.”

 A decade would pass before the AMA would issue an official statement on smoking and health, and the group opposed early efforts to regulate cigarette advertising.

While the 1964 report told smokers the dangers of cigarettes, in the 1970s the Surgeon General began warning America’s nonsmokers about the dangers of  smoke-filled rooms. Shopland recalled Surgeon General Jesse Steinfeld mentioning the health effects on nonsmokers when presenting the 1971 report to the National Interagency Council on Smoking and Health.

“The entire report was about smokers, but at the end of his presentation he said it was his opinion nonsmokers needed a bill of rights, that nonsmokers had the right to clean air instead of smokers having the right to pollute the air,’’ Shopland recalled. “We started getting mail from around the country supporting him. That first raised the idea that being around smoking was not a good idea.’’

 contained 3 chapters on “environmental tobacco smoke,’’ giving momentum to the nascent movement to restrict indoor smoking. By the end of the 1970s, 18 municipalities around the nation had passed indoor smoking ordinances.

The 1986 report was entirely about secondhand smoke,

 accelerating the momentum of nonsmokers pressing for clean indoor air. In 1995, California became the first state to pass a law regulating indoor smoking. Currently, 81.5 percent of the US population lives in a locality where indoor smoking is restricted; in many places, outdoor smoking is restricted as well

“You saw America acting as it usually does on social change,’’ said Connolly.  “At the community level people said they’d had enough; they deserved clean indoor air, they wanted an end to marketing to children. They combined the science from the Surgeon General with moral virtue. Smoking rates plummeted in America because of what common citizens did, not what Washington did. It’s the best public health story of the last century.’’

The single greatest blow against cigarette sales in the United States was landed in 1998 when the nation’s 4 largest manufacturers—Phillip Morris USA, R.J. Reynolds Tobacco Company, Brown & Williamson, and the Liggett Group&mdash;signed the “master settlement agreement’’ with 46 states. The agreement guarantees billions of dollars in annual payments to offset Medicaid costs for smoking-related disease. The agreement limits tobacco advertising, with particular restrictions on the use of cartoon characters and other devices for marketing to children. And, it forced the permanent dismantling of the Council for Tobacco Research, the successor to the TIRC. 

Knowledge of the dangers of cigarette smoking have seeped into the public consciousness to a degree unthinkable in 1964. This has allowed research priorities to shift as well, as studies turn to issues surrounding public education and health disparities; it is well documented that the effects of smoking hit hardest on low-income groups and the developing world.

October 2013, the American Thoracic Society and the European Respiratory Society published a statement in 

The American Journal of Respiratory Critical Care Medicine

 announcing the creation of a committee to address the fact that lower-level socioeconomic groups are 14 times more likely than higher-level groups to suffer from respiratory ailments, with cigarette smoking being a major reason

Smoking and Health: A Public Health Milestone

Surgeon General's 'Smoking and Health' Turns 50

Acting ahead of schedule, the US Food and Drug Administration (FDA) has granted an accelerated approval to ibrutinib (Imbruvica) as a treatment for patients with mantle cell lymphoma (MCL) who have received at least 1 prior therapy, based on a single-arm clinical trial demonstrating a durable improvement in overall response rates (ORRs).

In the phase II trial, labeled PCYC-1104, the oral first-in-class Bruton’s tyrosine kinase (BTK) inhibitor ibrutinib demonstrated an ORR of 68%, including a complete response rate of 21%. Moreover, the median duration of response was 17.5 months. Based on these data, the FDA granted ibrutinib a Breakthrough Therapy designation and the eventual approval.

“Imbruvica’s approval demonstrates the FDA’s commitment to making treatments available to patients with rare diseases,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “The agency worked cooperatively with the companies to expedite the drug’s development, review and approval, reflecting the promise of the Breakthrough Therapy Designation program.”

The PCYC-1104 trial enrolled 111 previously treated patients with relapsed or refractory MCL. The median age of patients was 68 years. According to clinical prognostic factors, 86% of patients had intermediate or high-risk MCL. In general, patients had received a median of 3 prior therapies, including bortezomib. Tumor response was assessed every 2 cycles according to the revised International Working Group for NHL criteria.

In the study, ibrutinib was administered orally at a 560-mg dose. The analysis of the trial was divided into 2 cohorts, based on previous exposure to bortezomib. However, prior treatment with bortezomib was found to have no effect on response to ibrutinib.

According to results published in The New England Journal of Medicine,

 an ORR of 68% was observed in patients treated with ibrutinib (complete response rate = 21%; partial response rate = 47%). The estimated median duration of response was 17.5 months and the median progression-free survival was 13.9 months. At a median follow-up of 15.3 months, the data for overall survival (OS) were not yet mature. However, the estimated rate of OS at 18 months was 58%.

“This is a meaningful day for previously treated mantle cell lymphoma patients, who are in need of new treatment options,” said Michael Wang, MD, an associate professor in the Department of Lymphoma/Myeloma at the University of Texas MD Anderson Cancer Center and lead investigator for the pivotal registration trial PCYC-1104. “With Imbruvica, we now have an important new medicine that is a once-daily oral therapy with a favorable risk—benefit profile.”

The most common ibrutinib-related adverse events in the PCYC-1104 trial were mild or moderate diarrhea, fatigue, and nausea. In total, grade 3 or higher hematologic events were infrequent and included neutropenia (16%), thrombocytopenia (11%), and anemia (10%). “We continue to explore Imbruvica’s potential to treat cancer patients in need. Presently we are in the midst of investigating this medicine in numerous additional B-cell malignancies with 37 clinical studies ongoing,” said Bob Duggan, CEO and chairman of the board of Pharmacyclics, the company developing the agent.

Ibrutinib is an irreversible small-molecule inhibitor of BTK activity. The agent works by blocking B-cell activation and signaling, which prevents the growth of malignant B cells that overexpress BTK. In general, BTK overexpression is abundant in B-cell malignancies, making this agent an effective treatment for many types of blood cancer.

The FDA is also considering ibrutinibas a treatment for patients with chronic lymphocytic leukemia (CLL), based on the same new drug application that resulted in the MCL approval.

1. Wang ML, Rule S, Martin P, et al. Targeting BTK with ibrutinib in relapsed or refractory mantle-cell lymphoma. N Engl J Med. 2013;369(6):507-516.

FDA Approves Ibrutinib for Mantle Cell Lymphoma

Federal regulators have ordered the direct-to-consumer genetic testing company 23andMe to stop marketing its saliva-based test without necessary approvals as a medical device, citing the potential for harm to patients who change medication doses or have unnecessary surgeries based on test results.

In a November 22, 2013, letter to 23andMe CEO Anne Wojcicki, the US Food and Drug Administration (FDA) stated that some uses being advertised “are particularly concerning,” including testing for BRCA1 and BRCA2 mutations, which are indicators for breast cancer, as well as sensitivity to certain medications, such as warfarin, a blood thinner that can be prescribed to prevent strokes or heart attacks.

The letter warned of the dangers to patients who act on the basis of false negatives or false positives without the assistance of genetic counseling. “For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist,” the letter states.

“Assessments for drug responses carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment,” continues the letter, which is signed by James L. Woods, deputy director for patient safety and product quality, Office of In vitro Diagnostics and Radiological Health.

The FDA’s action comes amid growing concerns by genetic counselors and some health plan experts that direct-to-consumer testing drives poor decisions by patients, especially if they consult doctors who have limited knowledge of genetics. Ellen T. Matloff, MS, director of Yale Cancer Genetic Counseling, Yale Cancer Center, has repeatedly raised concerns about women who use tests that skirt FDA requirements through an “entertainment” loophole in Federal Trade Commission (FTC) regulations.(

“There’s room for error in unregulated testing,” Matloff said during a panel discussion convened by T

 earlier this fall. She cited a Government Accountability Office (GAO) study, which found that it was possible to send the same sample to 4 different direct-to-consumer companies and get 4 different results.

Otis Brawley, MD, chief medical officer for the American Cancer Society, shared with the panel that he has treated women who had prophylactic breast removal  that later turned out to have been unnecessary. At Patient-Centered Oncology Care 2013, sponsored by AJMC in Baltimore, Maryland, on November 14-15, 2013, Jan Berger, MD, MJ, described a situation in which an employer allowed the use of flexible-spending accounts (FSAs) to pay for direct-to-consumer genetic testing. “It was a disaster,” Berger said.

Both the FDA letter1 and published reports3 describe an agency frustrated with 23andMe after years of negotiations aimed at getting the company to comply voluntarily with the approval process. The Wall Street Journal reported that the FDA issued its warning letter after learning that 23andMe had started a new marketing campaign, including television commercials, after letting 6 months lapse since its last contact with the agency.

Wojcicki has not commented; the company published the following statement on its website: “We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.”

Despite the consensus among genetic counselors that consumers need protection and guidance, the belief that people have a “right” to their own genetic information, and the ease with which the tests have been ordered, led to some backlash over the FDA decision. In 

 writer David Dobbs described the “cultural clash” between the FDA and Silicon Valley investors, including Google, that backed 23andMe.

“To 23andMe and to most of its customers, this is information that a person has every right to know,” Dobbs writes. “To the FDA, it is medical advice, which makes 23andMe’s delivery system medical device.”

1. US Food and Drug Administration. Inspections, compliance, enforcement and criminal investigations.November 22, 2013. http://www.fda.gov/iceci/enforcementactions/warningletters/2013/ucm376296.htm#.Upt_klMzTtk. email. Accessed December 1, 2013.

2. US Government Accountability Office. Direct-to-consumer genetic tests: misleading test results are further complicated by deceptive marketing and other questionable practices. GAO 10-847T. July 22, 2010. http://www.gao.gov/products/GAO-10-847T. Accessed November 30, 2013.

3. Loftus P. Genetic test service 23andMe ordered to halt marketing by FDA. WSJ.com. November 25, 2013. http://online.wsj.com/news/article_email/SB10001424052702304281004579219893863966448-lMyQjAxMTAzMDAw-MTEwNDEyWj. Accessed December 1, 2013.

4. 23andMe website. 23andMe statement regarding FDA warning letter [press release]. November 25, 2013. http://mediacenter.23andme.com/press-releases/fda-letter-2013/. Accessed November 30, 2013.

5. Dobbs D. The FDA and personal genetic testing. The New Yorker. November 27, 2013. http://www.newyorker.com/online/blogs/elements/2013/11/the-fda-vs-personal-genetictesting.html. Accessed December 1, 2013.

FDA Tells Direct-to-Consumer Genetic Testing Company to Halt Marketing

 convened a panel of leading medical professionals and genetic counselors to discuss how the exploding field of genetic testing is affecting cancer prevention, diagnosis, and treatment. 

 president & CEO, Health Intelligence Partners, and editor-in-chief, 

The American Journal of Pharmacy Benefits

, served as the moderator for a wide-ranging discussion, including issues that have arisen since June 13, 2013, when the US Supreme Court opened the door to competition in genetic testing with its 

, chief medical officer, American Cancer Society; 

 FACS, national medical officer, enterprise affordability and policy, Cigna; 

 genetic counselor, Hubert H. Humphrey Cancer Center; 

, research scientist, Department of Genetics and director, Cancer Genetic Counseling, Yale Cancer Center; and 

 MS, genetic counselor and president, National Society of Genetic Counselors.

The following transcript has been edited for clarity, style, and length. To hear the full discussion, please visit http://www.ajmc.com/ajmc-tv/paneldiscussion/genetic-testing.

: Let’s focus first on the unmet needs and challenges. What is the current uptake of genetic testing? We see increased utilization and increased availability. So are we seeing greater use? Is it in the employer market? Is it in the health plan market? Who’s leading the charge in this area? Ellen Matloff, would you get us started?

 I think the other genetic counselors on this panel have been much more involved in this area than I have to date, but my group has been able to document over the years some of the mistakes that are being made in genetic testing and also in prophylactic surgery, as well as surveillance for patients who aren’t getting the genetic counselling they need by a certified provider—both before and after having testing.

 Joy Larsen-Haidle, can you share what are you seeing as a genetic counsellor? Are you seeing an increased uptick in genetic testing?

 Yes, I am. Since the end of June there’s been a significant increase in the number of requests for genetic counselling and genetic testing, as well as differences in the type of testing that are available. I’ve been a genetic counselor for 18 years, and it’s been a lovely experience to watch that trend where genetic counselors have become more integrated in routine medical care. We are part of that conversation when patients and physicians are developing their care plan, and I think that trend will continue. With the court decision  and the media attention around BRCA testing that trend will likely continue.

 Dr Brawley, how are you all at the American Cancer Society both impacted by and impacting the current uptick?

 “Uptick” is actually a very good word. We’ve received many more calls to our 800-number from people seeking information. We have advised people to get genetic counselling before getting genetic testing. One of the tendencies that we’re seeing is that people who want genetic testing without the counseling. They sometimes want it ask for a specific test, and we have people who probably don’t need testing getting BRCA testing. There are those being tested for BRCA who probably should be tested for Li-Fraumini syndrome or other syndromes.

That’s interesting that you brought up the counselling before testing. Dr Finley, you know I can’t let you go without asking this: Cigna has made a precedent setting move of requiring— not just offering but requiring&mdash;genetic counselling by a certified provider prior to breast and colon cancer genetic testing. There’s been some noise to this and a bit of pushback. Do you believe other insurers will follow in your footsteps? And also, are there enough genetic counselors to meet the need for this protocol?

 I don’t have a hope whether the other insurers follow or don’t follow us. It’s not my primary or even secondary focus. I just hope that Cigna’s program will succeed in steering people toward genetic counseling and better care. Let me comment on the trend: As a payer we have the advantage of being able to look at claims history and see what’s happening in genetic testing. Our claims data show about a 15% annual uptick in genetic testing. And when I say “about,” it’s because of the change in coding that’s occurred. So, it is an estimate as the coding has changes from 2011 to 2012 to 2013. Our best estimate is a 15% uptick per year. I’m sorry, the last part of your question?

 I asked about the number of genetic counselors.

: I think there are better experts on this panel to answer the question, but the way Cigna looks at it, in some markets, the number of genetic counselors is adequate. In certain markets it’s not. I don’t think it’s one size fits all. In order to make sure that our Cigna customers can get the genetic counseling they need, we have contracted with a genetic counseling firm, IMD, that does these consultations telephonically; if there is a Cigna customer in a market where they cannot get a face-to-face appointment, that person can take advantage of the telephonic counselling with board-certified genetic counselors.

 If I can just say why women should talk to a genetic counselor before being tested—men for that matter, too, because occasionally we have men who want testing. As a physician, I have had to deal with women who have been tested and ended up with mutations of unknown significance, as opposed to a mutation that clearly increases significance by 40% or 80%. And what these women with mutations of unknown significance go through is just terrible&mdash;the emotional and mental anguish is terrible. Some of them actually force doctors to do bilateral mastectomies; in at least 3 instances I know of women have gone through this, and 3, 4, 5 years later what was a mutation of unknown significance is now known to be a mutation of no significance.

Then you have the other issue that I talked about earlier: those who, based on family history, clearly have a genetic pattern that might be a Lynch syndrome or might be a Li-Fraumini syndrome, but because they’ve heard about BRCA they insist on getting the BRCA testing. They don’t get tested for these other things. If I could just add one more thing: I agree with everything that you said, Dr Finley, and that’s one of the motivators behind our program. The other misunderstanding that I believe is out there, but I’d like your comment, is it true that some women misunderstand what the BRCA is and what it does, and they feel that if they’re negative for BRCA they don’t have to worry about getting breast cancer?

You’re absolutely correct; 95% of women who get breast cancer don’t have any of these mutations, and then there are mutations out there that we don’t know about yet. I can remember people were concerned when we had BRCA1, and women were tested for BRCA1 and they were so reassured that they tested negative for BRCA1, and then a few months later we had BRCA2;

those same women went through the same thing again and finally were found to be positive for BRCA2. There are other mutations out there that we don’t know about yet; and 95% of breast cancers are not due to genetic inheritance.

 Those comments are all very, very important; they help us to think through a logical pathway for both educating and utilizing counselors in an appropriate way. I want to reach out to our counselors and ask: being involved with genetic counselors and being genetic counselors, first, is there a concern regarding the availability and number? Second, I want to bring up the telephonic genetic counseling and your thoughts on that.

 Those are very good questions. As Dr Finley had alluded to, in certain markets in the United States there are many genetic counselors. In areas where the coverage isn’t what we would like, such as rural areas or certain states, I think the numbers do present a problem. But being able to use the telephone genetic counseling or even tele-genetic services has started to bring down that type of a barrier. Patients don’t have to worry about distance; they can still reach a qualified provider to do that pre-test/posttest counseling and have access to someone to appropriately interpret that results. We do see a difference, at least in my state, between the patients who are in rural areas and their level of resources and access versus the patients that are in metropolitan areas. I think it is an important resource to allow counselors to visit with the patient over the phone and still be reimbursed for that time.

: I agree. The other model that we’ve adopted is handling tele-genetic counseling by Skype. Our clinic can Skype to several local hospitals, where the patient can come in and sit with the healthcare provider, such as a nurse, who is their local contact person and has some limited expertise in genetics. It offers the benefit of having somebody local—and I think a lot of people in rural areas especially feel comfortable having that contact at a hospital that they’re familiar with, as well as a nurse who can help with referrals, while still getting the genetic counseling expertise through the phone or the computer. In terms of quality, I think there is an impression out there to this day that telephone counseling is not as effective as in-person counseling, and we genetic counselors worried about that for a long time. It’s been very well studied.

When you look at patient satisfaction and patient knowledge, there really isn’t significant difference between the patient sitting with you versus being on the telephone. Now, there probably are some areas where it’s better to be in person. Some pieces of that counseling occur more effectively when in person. But in terms of how the patients view it, they feel pretty satisfied by the telephone experience.

 That’s great to know. I want to turn for a moment to the Supreme Court decision in the Myriad case on June 13. I would ask: What have you seen as an impact on what each of you all do? I’d like each of you to comment on this. The press covered the Supreme Court ruling somewhat, but they did more with Angelina Jolie’s disclosure (about having a bilateral mastectomy after BRCA testing). Can each of you discuss what the impact of these events has been?

We had an unprecedented 3 months because the Supreme Court case went to trial in April, Angelina Jolie made her disclosure in May, and then the Supreme Court decision came out in June. We had a 40% increase in phone calls to our center during this period of time. One of my predictions before the ruling was that if the Supreme Court banned gene patents that within

3 months other laboratories would come forward and offer better, cheaper, faster testing. But wasn’t I surprised when we started getting e-mail advertisements within 5 hours of this decision! Other labs had been anticipating this, and they were up and running, not only offering cheaper BRCA testing, but much more comprehensive, better testing. And all of these labs were also offering (to test for) other genes. So as we’ve discussed, BRCA1 and BRCA2 are not the only 2 genes associated with breast cancer development; some of these panels now include, believe it or not, 40 genes that can be associated in breast cancer development. In my view, having also been in the field for 18 years, the entire playing field changed very, very quickly. We suddenly had all of these options—we could order more testing for less money or certainly the same amount of money that we were taking for BRCA analysis from Myriad. This is both a good and a bad thing.

One of the things that I’ve found is that we had meetings with our whole staff after doing hours of research into all of the options. What each lab was offering, how much it would cost, what the turnaround time would be, and what techniques they were using. What are the pros and cons of this testing for genes? Some genes are clinically actionable, but others are not, so perhaps we don’t want to know about them yet. And I thought to myself, “If we’re struggling through this, how is the facility or an independent physician’s office with no information about genetics going to now make these decisions—let alone interpret the results?”

 Interesting. What about some of the rest of you all?

With the Angelina Jolie news, we did see a brief but limited increase in the number of requests for utilization management. From the Supreme Court what we have gotten is about 4 or 5 inquiries from the labs that are offering the BRCA tests about contracting with us.

And some of the others? Are you busy? What are you finding?

 The Supreme Court had little effect on us. Long-term, with more companies in the market and more companies advertising, this could change. Keep in mind, prior to the Supreme Court decision, Myriad had significant advertising campaigns encouraging women to talk to the doctors about BRCA testing. I think you have more companies that are doing that now than you had prior to the Supreme Court decision. After Ms Jolie’s announcement—and I should point out that I thought her letter in 

was very well written and very responsibly written—we had a large number of calls. We heard from people who suddenly were very interested in BRCA testing, and, unfortunately, not interested in anything but BRCA testing. We’ve also seen an increase in the number of women getting bilateral mastectomies, which may actually be unfortunate as well. Ms Jolie said it was the right decision for her, but it was not right for every woman, and I think that’s absolutely correct. Many women who chose to get a bilateral mastectomy, if they were to sit back, think, and understand everything about it they might choose a different method of treating the present breast cancer.

: Does anybody else have anything else they’d like to share on that?

: I have to echo what everyone has said. Ms Jolie’s announcement, which was courageous of her, resulted in a marked increase in the number of calls coming into our office but also in our referring provider network. Most of those calls were women who were what I’ll call “the worried well,” who had heard about the story and had a concern, but in most cases DNA testing would not have been appropriate for them. The genetic counseling realm helped to put that risk into perspective for them, and to help them understand why testing was not indicated for their family even though it was necessary for Ms Jolie’s family. Our volume has sustained about 2½-fold higher than prior to her announcement. Her story raised a lot of general awareness.

I have to agree with what Ms Matloff and Dr Brawley and Dr Finley said about the Supreme Court decision. For us the testing choices have changed dramatically.It becomes important for us to look carefully at each of these panels and ask, what are the genes that are analyzed? How effectively are each of those genes analyzed, compared with what panel fits best with the person that’s sitting in front of me? … So the costs of testing have gone down, but it’s also allowed us to expand and address and on the same test another 20 to 25% of families that have an inherited risk. From the genetic counselor’s standpoint, over the last year we’ve done some careful work trying to identify data. There are some studies out there that do indicate that when the genetic

counselor is the person evaluating that family history, that we will identify risk factors that might be missed by other providers without specialized training in genetics. We have to identify those patients and, as Dr Brawley had mentioned, they may not need BRCA testing. They may need testing for Lynch or P53 or some other gene.

 That’s a great lead-in to my next question: Let’s talk about the providers for a moment. How are they getting their education? How are they keeping up? There may be a number of providers that the patient population would be seeing, whether it’s a nurse practitioner, a primary care doctor, an OB-GYN, or potentially somebody with greater specialty. But in the general healthcare area of the family physician, the PCP, or the nurse practitioner, is there confusion? How are they reacting to everything out there?

I practice as a medical oncologist, and I’m a firm believer that there are so many things out there that no one person can master everything. So I think it’s impossible for a generalist to understand everything that a person needs to understand about genetic counseling or about genetic testing. That’s among the reasons I think it is very important for most of us, including myself, to refer patients to a genetic counselor for a conversation, even if that conversation has to happen over a telephone. A genetic counselor brings something to the table that many of us physicians simply cannot.

Think about the training. Within the medical school curricula now there is more focus on genetics. There is more than there was maybe 10 years ago.

That’s good to know, because when I trained there was very little, but that was in the dark ages.

November/December 2013

The Quest for Better Survivorship: Guidelines Promote More Accountable Cancer Care

Surgeon General's 'Smoking and Health' Turns 50

FDA Approves Ibrutinib for Mantle Cell Lymphoma

FDA Tells Direct-to-Consumer Genetic Testing Company to Halt Marketing

Genetic Testing Should Come With Counseling: American Cancer Society CMO, Supreme Court Plaintiff Among Experts Who Warn of Consumer Risks

Oncology Groups Active in Effort to Repeal SGR

Current Thinking Behind Decision Making in Oncology Clinical Pathway Design

Safety Concerns Halt Ponatinib Development