Time. The dead float free of it. But for the living, particularly for the hundreds of millions of people touched by cancer, time is everything. President Biden’s Cancer Moonshot https://www.whitehouse.gov/cancermoonshot/ aims to cut the death rate from cancer by at least 50% over the next 25 years. Is that feasible?
The numbers are stark: more than one in three Americans develop cancer. More than half of those diagnosed will die of it. https://sph.umich.edu/podcast/season1/cancer-prevention.html
Relatively few patients who are able to benefit from cutting edge treatments will die of cancer. Those treatments now include experimental ones and ones personally tailored to their disease. Like my mother, most will die because they did not have the right treatment at the right time, even though, theoretically, they did have access to it
Research is forging ahead, bringing new life-saving treatments capable not just of giving more time to patients or even turning cancer into a chronic disease, but of curing cancer. The acceleration of research into gene-based treatments due to the COVID pandemic is now yielding results in the development of radically new cancer treatments.
In recent days, companies such as Merck and Moderna announced successful phase 2 clinical trials of mRNA cancer antigen vaccines that, administered together with immunotherapy, can protect from solid tumors and in some cases cure these cancers even when advanced. https://fortune-com.cdn.ampproject.org/c/s/fortune.com/well/2022/12/13/skin-cancer-vaccine-moderna-merck/amp
These innovative treatments can also be administered outside clinical trials to certain patients for whom there is no other treatment, and who are under the care of physicians involved in this research, in facilities that have invested heavily in groundbreaking research, allowing their research institutions to provide their clinical facilities with new therapies many years before they become standard in the community.
Yet most patients do not have access to these treatments. Lack of health equity is the big killer of cancer patients today.
Many top cancer centers do not offer their services to patients with bad health insurance or to the uninsured. In states that have not expanded Medicaid, like Texas, these people do not have access to any cancer treatment at all.
If federal or state programs, like the one offering free breast, cervical and colorectal cancer screening to eligible, uninsured and underinsured men and women in every county and borough in New York State https://www.health.ny.gov/diseases/cancer/screening/ were expanded to include lung cancer and skin cancer screening, and in all states, the most lethal cancers would be in almost all cases be caught at very early stages, when they are easily curable.
For cancers that have metastasized, having money as well as good health insurance is vital. Having family members who can educate themselves on options and treatments, and act as advocates and caregivers is also vital for the patient, not least because in regard to first-line treatments, there are usually several options available to patients.
The National Cancer Institute may annually issue its guidelines, it does so however by usually adding new treatments as “equal” alternative options, even though they are not. The problem is that due to conflicts of interest, there are no clinical trials comparing between new drugs with the same target produced by different pharmaceutical companies: each new drug is tested by the pharmaceutical company that produces it against the previous standard of care. This leaves clinicians to hesitantly–research is always sponsored by pharmaceutical companies–and over the course of years of clinical observation, discover the differences between the drugs and determine which subset of patients would benefit most from which drug.
Health inequity extends to clinical trials.
While almost three quarters (71%) of people who have never participated in a clinical trial indicate they would be willing to do so, 90% indicate that they have never been asked by their doctor. Among individuals managing a disease, less than 25% have had their doctor or nurse suggest a clinical trial as a treatment option. Ironically, of the $7 billion that is the estimated annual cost of U.S. clinical trials, nearly $2 billion goes toward patient recruitment.
Though several cancers disproportionately impact racial and ethnic minority groups, they continue to remain underrepresented in clinical trials. The 2022 AACR Cancer Disparities Progress Report reported how among 207 pancreatic clinical trials, Black (8%) and Hispanic (6%) patients were underrepresented, despite Black patients having the highest incidence and mortality rate of pancreatic cancer.
Additionally, women, particularly older women, remain underrepresented in lung cancer, melanoma, and pancreatic cancer trials, despite the higher prevalence of these cancers in women.
Enrollment barriers include limited health literacy, healthcare system mistrust, physician bias, consent availability in only a singular language, and a financial burden, especially for minority populations. Structural barriers include clinical trial complexities, patient exclusion due to narrow eligibility criteria, lack of translators or patient navigators, and lack of trial availability in areas with a high proportion of racial and ethnic minorities.
A little known fact about clinical trials is that pharmaceutical companies and research institutes always administer the under-trial drugs or perform the experimental interventions for free. However, the hospitals where these drugs are administered and interventions performed charge patients for out-patient services rendered. If a patient’s insurance company refuses to cover these costs or a patient does not have insurance, they cannot participate in the “free” trial.
Even among insured cancer patients, there is significant difficulty in obtaining insurance authorization for various imaging modalities such as PET/CT scans and MRIs. Patients also frequently encounter denials of coverage for F.D.A.-approved drugs and treatments that they urgently need. For all its failings, Twitter has become a place where doctors regularly air their frustration toward insurance companies, in an effort to shame them into doing what they should: allow patients to follow the treatment their doctors deem urgently necessary. https://twitter.com/AaronGoodman33/status/1618410012099096576
Dr. Glaucomflecken, a doctor become YouTube and social media influencer with millions of followers, has raised awareness around this issue with his scathing videos where he performs sketches of how employees at insurance companies arbitrarily deny treatments, tormenting the requesting physicians. https://www.youtube.com/watch?v=FVAFfd3oCgA
Even when a treatment has been authorized by the insurance company, cancer patients still find themselves struggling with ludicrous out-of-pocket costs and co-pays for many provider visits and treatments. Financial toxicity has become inextricable from cancer for most patients.
Physician bias also frequently determines if a patient lives or dies. Patients, particularly those of low socio-economic status, and/or belonging to underrepresented groups, including individuals with disabilities, older adults, non-English speakers, are still restricted to anachronistic, inefficient treatments.
People over 80 are often not adequately informed of the treatments available to them, or are treated with drugs and interventions inferior to the standard of care just because they look more frail, and hospitals desire perfect outcomes. A common example is the frequent use of SBRT instead of surgery in patients over 80 years of age, with early-stage non small cell lung cancer. A recent study revealed that 6 months after either surgery or SBRT, the rate of mortality was almost the same. Yet the median survival time of the elderly patients who had surgery was 56.4 months, while only 35.5 months in those who had SBRT. https://www.frontiersin.org/articles/10.3389/fsurg.2022.1018320/full
A 2018 analysis of over 20,000 patients with pancreatic cancer also found that older age and minority race/ethnicity were associated with lower likelihood of receiving chemotherapy, radiation, and/or surgery. https://onlinelibrary.wiley.com/doi/10.1002/cam4.1277
Even when it seems a patient is nearing the end, doctors still have last-resort interventions they can try: Any treating physician can request that the FDA allow compassionate use (or expanded access) or emergency use of experimental medications and/or interventions for patients in life-threatening situations in which there is no longer any standard acceptable treatment or the possibility of participating in a clinical trial.
Cancer inequity is even more striking in areas where pharmaceutical companies, the flourishing biotech industry, and insurance companies intersect. There are, for example, genomic personalized tests, most not covered by Medicare and Medicaid, that immediately indicate to which among multiple “similar” drugs a specific cancer patient will be most likely to respond. These tests usually involve only a blood-draw, but are performed on few patients, those with privileged access to knowledge, money, excellent insurance, and extraordinarily knowledgeable and devoted doctors.
At the same time, the pharmaceutical market operates unchecked with little governmental regulation. As a result, the cost of cancer drugs continues to surge, even when later studies demonstrate that the drug is not as effective as it was originally touted to be.
In other cases, pharmaceutical companies exploit legal loopholes of U.S. patent law at the expense of patients and taxpayers. The NYTimes recently revealed that the drug company AbbVie made $114 billion by gaming the system for years to delay competition for its blockbuster drug Humira.
The “revolving door” between the F.D.A. and the pharmaceutical companies also sometimes creates situations where approval is given to a new drug and then, after uproar in the medical community, withdrawn. Such is the case of Biogen’s Aduhelm, an Alzheimer’s drug that doctors and scientists claimed was useless and dangerous. A congressional investigation found that the FDA’s “atypical collaboration” to approve “the unjustifiably high-priced” drug was “rife with irregularities.”
It is clear that the entire biomedical community, including patients, patient advocates, philanthropic donors, and nonprofits, needs to unite in realizing health equity so that patients can receive the treatments they need when they need them.
Whether the person who gives your life meaning has cancer; whether you are a doctor struggling so patients can have access to treatments that can save them; whether you yourself are a patient racing against time and every kind of obstacle: ensuring that the Cancer Moonshot is successful is up to you, for you, for all of us.
