Cynthia Martin, MA is a freelance/ghost writer (who tried to write a serious piece).

Q: As a journalist, you are a savvy native Canadian consumer/patient who also knows a lot about the United States. What do you see as the main similarities and differences between cancer prevention and care in the US and Canada?
A: Writing a 500-word answer to this is like trying to boil down 40 gallons of sap collected amid a chilly stand of trees to make 1 gallon of maple syrup. If all goes well, you get a dreamy confection where waffles are merely a delivery system. If not, you get a soggy gooey mess leaving you with sticky pails and spouts, a burnt-out fire, cranky people who remind you they could have spent the day elsewhere, an awful friggin’ lot of cleaning up and a spike in wine sales at my closest store.
I started in healthcare in 1985; written and ghosted a whack of health material including on cancer, volunteered and taken care of friends including my best friend who died partially from sheer weariness and partially because a doctor missed his calling as a government clerk. I read, I nod, I empathize, I sympathize and I get mad. Then I forget until a fresh sad story comes along; so I’ll first address the main difference. With the US a market-driven system – which is very bad for healthcare – your cancer services are slick and self-serving, like a smarmy blind date who shows up perfectly groomed with an IQ of 49 who mowed down the uninsured and underinsured to get to me. Under that difference is that Canadian parents don’t have to mortgage houses to pay for a child’s cancer care, Canada doesn’t have the many hundreds of insurance companies as in the US; with overhead and administrative costs dramatically reduced if rolled into a single-payer system the US would see enough savings to cover every citizen.
Turning to similarities between the two countries, my overarching thought is we should all be ashamed. Ashamed, as Brian Klepper wrote on this blog, “Cancer care is such lucrative business that more than one in four health systems is now building a cancer center.” Ashamed, that since Richard Nixon declared a war on cancer in 1971, cancer became the disease dominating the zeitgeist of the past 45 years (!!!!) Whether another touching tribute in an father’s obituary who “fought valiantly” or sister who “battled bravely” – I’m sure that’s not what Nixon meant. You bet cancer is lucrative: with more than 56,400 clinical trials listed it’s not disappearing soon.
Another similarity is urban and rural cancer services; both the US and Canada are large landmasses which make comprehensive services impossible. This makes me want to run screaming off the end of my closest wharf since I do indeed live in a semi-rural area and if I got cancer, would be screwed in the bad kind of way (oh really, I’m the one not taking cancer seriously?).
Also similar: prevention is largely an afterthought, like no-name condiment packages stuck at the back of a drawer (“Right, we have some of that somewhere…”). In 2015, it was estimated that in the US 1,658,370 new cancer cases would be diagnosed with 589,430 cancer deaths; and 196,900 Canadians would develop cancer and 78,000 die of cancer. If extrapolated into deaths from plane crashes – say Boeing’s 737-800, likely the most common large aircraft–that’s some 43 planes full of individuals a day. I know those stats can’t be compared but think of each person as a mother, lover, child –losses impossible to calculate correctly. In a small sign of related prevention, consider Mexico, which applied an 8% tax on “non-essential” food in January 2014, seeing junk food sales drop 5.1%, while our governments dilly-dally. The only two jurisdictions: Berkeley California’s health tax on sugar-laden drinks (must be the dreamcatcher earrings) while Philadelphia’s recent vote for its sugary-drinks tax was approved precisely because it was pitched as a tax measure for city revenue. That the beverage industry spent $10.6 million to thwart Philadelphia’s tax is obscene, like opposition (in large part by US health insurance companies) to 1993’s US Health Security Act and recently Obamacare – your two-party feuds are emblematic, wasting so much energy and time, being infinitely more precious than jettisoning partisan vested interests for the good of your citizens.
Soon after she was appointed the 18th US Surgeon General, I interviewed Dr. Regina Benjamin. She seemed she’d bring spunk and honesty to the role, especially when she said disco dancing was exercise (be still my heart). But the PR gauntlet I had to negotiate told me not to put that in (it’s an article pull quote). One of Dr. Benjamin’s hopes was to see a “smoke-free world,” but…poof she resigned. I’m thinking since she was muzzled on disco dancing even whispering “Let’s address tobacco use” would have been like a scene from a mob movie, her being bundled out her office rolled up in a carpet. People have completely lost their minds and souls and misdirected their talents since Nixon’s proclamation. So very much has been and is still written and discussed and debated, so very many trial balloons sent up by politicians as to which policies incur less wrath and fewer lost votes, so many millions of people needlessly suffering and ever lost to us – because the will is not strong enough to shut down tobacco and change taxing policies, corral lobbyists and target chemicals, take less from whatever payment system because – oh, it’s great going to conferences (saying the same things said for decades). Although I deeply adore Obama and Biden, now there’s a Cancer MoonShot, as American as the war on cancer.
No cancer isn’t funny, not even the black humour wit needed to work in healthcare, nor are greeting cards now cheerily saying “Cancer Sucks!” instead of “Get Well.” I’m trying not to mention pink ribbon marketing so here’s a musical interlude. The lead singer of an iconic Canadian band has glioblastoma winding up their supposed last tour, every station playing their music ad nauseum as media, the public (many of whom never paid attention to the band prior) and medical community fawned over his “bravery” – as if he is the only patient in their waiting room, as if he is the only person to ever have cancer and be prescribed its itchy coat of hope – as if he is the ONLY one who will die. Meanwhile, funds roll in to cancer research and – of course – the band. Not so for the lead singer of another Canadian band, who has early Alzheimers and wound up his tour quietly–so Canadian-like – but then Alzheimers isn’t as sexy. The twin brother of a British guitarist, not parlaying cancer into sales, just announced his twin’s death at 28, while yet a member of another iconic Canadian band – who’s going to die somehow not raking in teary-eyed royalties – quit to work at a library. This is all so very very – to use a scientific term – nuts.
I hope I can hear keyboards stirring to action…not to flame me for opinions on this soggy gooey mess (don’t shoot the messenger), but in a universal demand for an end to cancer, mad enough to bite down hard, not just nibble away ad nauseum at its margins.
Copyright: This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Keith Flaherty, MD, Associate Professor of Medicine, Harvard Medical School; Director of Developmental Therapeutics, Cancer Center, Massachusetts General Hospital.

Q: Under what circumstances and to what extent are you willing to take clinical actions on a cancer patient based primarily on preclinical data?
A: There are two scenarios that come to mind when thinking about reliance on preclinical data for treatment decision-making: (1) use of an agent that is an established treatment for a noncancer indication and (2) use of an established cancer therapy outside of the context(s) for which there is known clinical efficacy.
In the first scenario, I am essentially NEVER willing to accept a preclinical finding that suggests efficacy as a basis for prescribing use of such an agent. This perspective comes from a career focused on performing early phase clinical trials with agents that demonstrated promising in vitro and in vivo effects that failed to exert any discernible effect in cancer patients.
The explanations for these failures are numerous, but the most common explanations are inability to achieve the drug concentrations/exposures needed to match those used in preclinical experiments and lack of fidelity of the preclinical model systems for predicting outcomes in patients.
This second category remains a major challenge for many cancer therapeutics in that we simply do not have a repertoire of ex vivo or in vivo model systems that fully recapitulate the complexity of human cancer with regard to the molecular features of the cancer cells themselves, the tumor microenvironment, and an intact immune system. This is a greater or lesser liability for certain classes of cancer therapeutics, but we generally cannot be dogmatic about which mechanisms of action will translate across preclinical and clinical settings.
Regarding the scenario of using a cancer therapy with known efficacy in some context for an off label indication based on preclinical data, I am generally more willing to consider this possibility, though it is infrequent in clinical practice that such an approach trumps direct clinical evidence for a repertoire of therapies in a given cancer indication.
When thinking about specific types of systemic cancer therapy (conventional cytotoxic chemotherapy, oncogene targeted therapy, and immunotherapy) there are very real differences in cancer biology that relate to variable efficacy for each across Cancer types. Several years ago, we had hoped that this would not be true for the activated oncogenes for which molecular targeted therapies have been established as effective and at least one contact. BRAF mutations are, perhaps, one of the best examples here. We know that BRAF mutations are found across the majority of cancer types, though at very low rates in many of them. Going into the first clinical trials with selective BRAF inhibitors, we were equally optimistic regarding potential efficacy in melanoma and colorectal cancer, but came away with enormous enthusiasm in melanoma and essentially no efficacy in colorectal cancer.
Extensive laboratory research subsequently help to explain the relative resistance of BRAF mutant colorectal cancer, but it was not a phenomenon predicted by preclinical models prospectively. In fact, it is this type of example that motivated the NCI MATCH trial which is broadly exploring molecular targeted therapies in cancer patients where the molecular features are the basis for inclusion in a given therapeutic arm, not cancer type.
In other words, we take it as conventional wisdom currently that we do not have a basis for predicting efficacy when exploring these types of approaches across the spectrum of cancer types.
Copyright: This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Y. Tony Yang, ScD, LLM, MPH., Associate Professor, Department of Health Administration and Policy, George Mason University, Fairfax, Virginia. Charles Bennett, MD, PhD, M.P.P., Smart State and Frank P and Jose M Fletcher Chair, Medication Safety and Efficacy, Smart State Center of Economic Excellence, University of South Carolina and the Hollings National Cancer Institute Designated Cancer Center of the Medical University of South Carolina, Charleston, South Carolina.

Q: Are biosimilars the same as generic versions of biologics? Will they be approved by the FDA? Are they safe? Are they cheaper? What about the intellectual property rights of the manufacturer of the reference biologics? If they are only slightly less expensive than the reference biologics, why would anyone prescribe them- particularly if we are not certain that they are as safe as the reference biologic?
A: Biosimilars are NOT generic versions of biologics. Biosimilars are HIGHLY SIMILAR to the reference product they were compared to, but have allowable non-clinical differences. Differently, generic drugs are copies of brand-name drugs, have the identical active ingredient, and are the same as those brand name drugs in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Biosimilars are produced from a living organism; therefore, it is impossible to produce an exact copy of the reference biologic. Two biosimilars are approved in the U.S. as of July 2016: one is marketed (Zarxio, a Neupogen biosimilar) and the other is involved with patent litigation (a Remicaide biosimilar approved in April). A third and fourth biosimilar received unanimous votes in July of support from FDA’s Arthritis Advisory Committee (a Humira and an Enbrel biosimilar) although patent litigation may occur before marketing is allowed to begin.
For years, biosimilars have been approved and safely used by patients in Europe, Japan, Australia and other countries. While the regulations for approval are similar internationally, Europe has been way out in front on approving biosimilars and the U.S. is just entering this market. The biosimilar approval in developed countries relies on each country’s regulatory agency’s previous findings that the agency-approved reference biologic is safe and effective.
Although biosimilars in the U.S. are not expected to provide the 70-80 percent savings we have seen with traditional generics, biosimilars have historically cost at least 20-30 percent less than the reference product, which can cost over $100,000 per year. Zarxio came to market in the U.S. at a 15 percent lower cost than its reference biologic. That implies the price differential between a biologic and its biosimilar is more likely to approximate the competition in a multi-brand category of drugs rather than between a reference drug and its generic. Nevertheless, these cost savings from biologics help give patients access to these complex drugs. By improving access to biologics through biosimilars, more patients have the potential to receive life-changing treatments. The reduced cost of biosimilars will also lead to substantial cost-savings in the broader healthcare market. Although it remains to be seen as the biosimilar pipeline continues to mature in the U.S., it is estimated that the U.S. health care system has the potential to save up to $250 billion by 2024. These savings create resources to enable access to other innovative treatments, improving the lives of all patients.
Biosimilars were first allowed under the Biologics Price Competition and Innovation Act (BCPIA), a section of the sweeping 2010 Affordable Care Act. The BPCIA acknowledges the significance of promoting innovation, but it also provides a pathway for competition once monopoly protection ends. Biologics can acquire patent protection, which lasts for 20 years from the date the patent application is filed. The BPCIA stipulates a 12-year market exclusivity and a 4-year data exclusivity beginning when the biologic drug secures FDA marketing approval. Each exclusivity can be extended 6 months for pediatric applications. A biosimilar cannot be marketed until the 12-year exclusivity expires. These exclusivity protections are designated to stimulate biologic research and development. However, if the politically controversial Trans-Pacific Partnership between the U.S. and 11 other Asia-Pacific countries is approved, exclusivity could drop to 5 years. Stay tuned and the next few years should be exciting times for biosimilar approvals and uptake in the U.S.
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Brian Klepper, PhD, CEO and Founding Principal of Health Value Direct

Q: Many of us have been touched by the publication of your sensitive but serious criticism of your wife’s care once her ultimately lethal peritoneal cancer had spread. How do you propose that oncologists, patients and their families should best practice “shared decision making”?
A: Sad but true, most cancer patients today unknowingly enter highly conflicted treatment environments where, as a practical matter, the ideal of shared decision making may run counter to the provider organization’s interests. Cancer care is such lucrative business that more than one in four health systems is now building a cancer center. Physicians or the health systems they work for typically profit from the drugs they prescribe, which often lack evidence of efficacy. These vectors often result in care decisions that accrue more to the health system’s than the patient’s benefit.
Patients should assume that their physicians have their best interests at heart but, in complicated, unfamiliar territory, insist on asking hard questions. Doctors are increasingly aware that their role includes making patients aware of their options, but they, like all of us, may also have inherent biases that manifest in what treatments they urge for their patients.
Physicians can be optimistic about outcomes and patients may be unreasonably hopeful, so an honest evidence-based assessment of current realities is critical. What benefits will the treatment realistically buy the patient and how much of an ordeal will it induce? What are the odds of success and what, exactly, is the definition of success in each case? The goal is to arrive at care decisions based not just on abstract notions of what works better, but on results that will be meaningful to the patient’s and family’s lives.
Treatments that buy a few extra days or months may not be worth it if adverse effects make that additional life miserable. And palliative care data over the past few years has shown that stopping after failed 1st or 2nd line chemotherapy often lengthens life by 2-3 months and improves quality of life over conventional therapy.
It would be particularly useful to know whether the vast majority of cancer patients who have gone through aggressive therapy and are about to die believe in hindsight that it was worth it. That voice of experience would be critical new information for patients, and validate or counter many physicians’ arguments that they prescribe all-but-hopeless treatments because many patients demand any chance. Of course, studies are less fundable when they aspire to less treatment and are not in the care community’s financial interests.
In Being Mortal, Atul Gawande MD’s profound and wonderful book, he presents 5 questions for patients at the end of life, developed by Susan Block, a palliative care physician at the Dana Farber Cancer Institute in Boston.

1. What is your understanding of where you are and of your illness?
2. What are your fears about what is to come?
3. What are your goals as time runs out?
4. What tradeoffs are you willing to make?
5. What would a good day look like?

The beauty of these questions is their deep humanity. They clarify the patients’ understanding, worries and priorities for the patient and family, and help clinicians know what matters most to them. My wife Elaine referred to them as “perfect questions.”
In British Medical Journal, Richard Lehman MD sums up the shared decision making problem this way. “We urgently need every paper about a new oncology drug trial to incorporate a comparative infographic, compiled by an independent author from the individual patient data. This could probably be done for the same cost as a single course of the treatment.”
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Valerie Fraser Cancer Research Advocate/­Patient Navigator;
Inflammatory Breast Cancer International Consortium (IBC-IC)
Huntington Woods, Michigan

Q: What are Patient Navigators and why are they sometimes necessary for some cancer patients. How do the best programs work?
A: As precision medicine, information technology and an increasingly savvy internet society merge, there will be a greater expectation that patients be involved, informed and engaged with their healthcare team. Navigators will be pivotal in this process, both those that are within the healthcare system and increasingly those that are lay navigators outside of the system. Lay navigators are often resourceful survivors or caregivers themselves, experienced in research and the health care process, with critical skills, resources and most importantly the “heart connection” that patients will need throughout their cancer experience.
Accessing resources and seeking quality care for those diagnosed with cancer is a demanding and complicated process. A patient’s survival can be impacted by critical decisions, so there’s the pressure to get it right. The reality of receiving a cancer diagnosis begins with an avalanche of emotion, anxiety and uncertainty both for the patient and their family. Many patients will inevitably encounter barriers along the way and face important crossroads critical to their care. Often they will feel buried and paralyzed under the weight of a system focused on time and process and may feel uncomfortable with their ability to question or evaluate the process. With multiple experts and treatments involved, it is often difficult to transition levels of care. Many also experience long term side effects following treatment, impacting their transition from patient to survivor.
Patient navigators are resourceful problem solvers there to guide patients through a difficult experience often never encountered before. They help to prevent and eliminate barriers to quality care and treatment, locate resources and often act as a communication liaison between the patient and the care team. A navigator can help support patient satisfaction through their compassionate guidance, often having first hand experience as a cancer patient themselves, resulting in improved quality of care and overall outcomes. Navigators are also self-advocacy educators and encourage patient empowerment improving a patient’s overall outlook, engagement and quality of life. Studies have shown this is often a win-win for the patient, their care team and their treating institutions.
The best navigation programs are those that are resource and information rich and designed from a patient perspective. A navigation program must be adaptable and broad so as to provide the best information, resources and guidance while at the same time engage and empower patients in the process. Personalized needs assessment and evaluation of patient satisfaction throughout the navigation intervention supports optimal outcomes. As addressed in the landmark 2005 IOM report “From Cancer Patient to Cancer Survivor: Lost in Transition” the key components of delivering high quality cancer care must include patient needs, values, preferences and engagement with the care process.
Cancer is unwanted, unplanned, unscheduled and a very personal experience for those diagnosed. Patients are faced with critical decisions while dealing with overwhelming stress. A navigation plan must be designed around the individual and their unique needs. The best programs will be focused on clearing away barriers and uncertainty while rebuilding a pathway to patient empowerment and survivorship.
Patient Navigation is a rapidly growing and evolving industry especially in cancer care. A patient navigation requirement is now part of the Commission on Cancer institutional accreditation to ensure patient-centered care. Health care institutions and cancer centers developing their programs, often assign nurses to fill these positions who focus on patients at that particular institution. Salaries for Oncology Nurse Navigators can average anywhere from $67,000+ annually . Private/Professional Patient Navigators work independently as consultants with various organizations and individually one-on-one with patients. Their fees are often hourly and can vary based upon the scope of their services, demographics, background and experience, etc..
Patient Navigators are filling important roles in an increasingly complex cancer health care system. Their involvement in patient-centered care will undoubtedly continue to grow and add value to a health care system striving to better serve their cancer patients. However, their real impact will be in the immeasurable value they provide to patients and families on the receiving end of a life threatening cancer diagnosis often overwhelmed and lost in the maze of the cancer experience and process.
Copyright: This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.