When Oncologists Look at Oncology, They See the Same Dire Shortages Year After Year

Survey Research at the Clinical Frontlines

In August and November 2011, we wrote here about the increase in oncology drug shortages and the implications for oncology patient care.  We’d been moved by alarming media reports, including a New York Times Op-ed by Ezekiel J. Emanuel, MD, PhD, to poll oncologists about their personal experiences in the January 2012 wave of our ongoing survey initiative, “Oncologists Look At Oncology". 

Nearly all of the 204 oncologists (95%) who participated in our 2012 survey had seen patients in the prior year (2011) who were unable to receive timely treatment due to drug shortages, with half (49%) encountering this problem on at least a monthly basis throughout the year.  A full 85% said they’d had patients who were unable to receive the best therapy at all because of drug shortages.  Those data were taken to Capitol Hill by the Community Oncology Alliance as part of a broader conversation that involved Congress and FDA.  Some constructive solutions were proposed by health advocates and policy-makers while essentially nothing happened.  We have become a society that is extraordinarily patient with the unacceptable. 

Cue 2013, and another round of surveys.

This past week, the American Society of Clinical Oncology held its annual meeting in Chicago.  At that meeting, Dr. Emanuel and Dr. Keerthi Gogineni reported the results of a new survey of oncologists which they and their colleagues at the University of Pennsylvania conducted in Fall/Winter of 2012-13. Sadly, they continued to find that 92% of oncologists say that their patients’ treatment has been affected by shortages and 83% have been unable at times to prescribe standard chemotherapy. 

The Deplorable ‘New Normal’ Requires New Guidelines

Oncologists feel that they lack formal guidance about how to make allocation decisions and, therefore, that they must improvise their responses when drugs are unavailable.  Oncologists have substituted scarce generic medications such as leucovorin with more expensive branded options, but the implications of swapping drugs involve far more than reduced cost-effectiveness.  They can lead to reduced efficacy and increased morbidity.

In an interview with CBS Radio, Dr. Gogineni commented that, “These are substitutions for which we sometimes don’t have data about how that affects the outcome for a patient.”  She went on to suggest that guidelines are needed to inform and standardize the decisions oncologists make in times of scarcity.

And indeed, a disheartening number of oncologists polled in our 2012 survey were already convinced that patient outcomes have already been affected by shortages.  Almost half (48%) believed they had had patients whose tumors had recurred because of drug shortages and 40% had at least one patient whom they believe had died sooner. Opinion surveys of oncologists cannot and should not carry the weight of well-designed empirical assessment of patient outcomes, but oncologists are the first to see that these shortages have consequences, and we ignore the early warnings at patients’ peril.    

Safeguarding Legacy Drugs While We Still Need Them

Oncologists have always prided themselves on practicing evidence-based medicine long before “evidence-based” had become a medical mantra.  We should be indignant that patients are now forced to be treated with something other than the evidence-based standard of care simply because we have not found a way to ensure the availability of the best medicines.  And we should despair to think that things have gone so far that there is now a call for new guidelines to compensate for loss of old but important drugs.  Our emphasis on medical discovery should remain absolute and unqualified. But there is grim irony in the implication that forward progress toward newer, more expensive therapies continues to have as an unintended consequence the loss of cheaper therapies we already know to be critically important.

A Survey of Battlefields in the War on Cancer: Oncologists Reporting from the Front Lines

In 2008, we launched an oncology market surveillance program, “Oncologists Look at Oncology: Prognosis for U.S. Cancer Care.” We were moved to do this by what we were hearing from oncologists as we conducted in-depth interviews with them on behalf of our clients. Our clients in the field, who range from small startups to leading “Big Pharma” companies, shepherd innovative molecules from the bench to the clinic and, if successful, to the commercial marketplace. But over 35 years after the “War on Cancer” was famously declared by President Nixon in 1971, what we were hearing from oncologists on the front lines of cancer care was a sense of frustration, even despair.

A significant part of oncologists’ frustration at the time was financial. In 2006, Medicare and Medicaid reimbursement to physicians for in-office intravenous cancer medications was cut dramatically. Private practice oncologists had been earning 50 percent or more of their total personal income from profits on IV medication -- profits earned directly from reimbursement paid by public and private payers. The industry published fictional “average wholesale prices” (AWP) that set the reimbursement physicians would receive, but physicians were able to purchase drugs at prices substantially below AWP. Centers for Medicare and Medicaid Services’ updated reimbursement policy based on actual average selling prices rationalized reimbursement but changed the game for oncologists.

But loss of personal income wasn’t the only thing that seemed to have disheartened oncologists. They told us that they were sending more patients to hospitals for drug administration when coverage was uncertain -- even though patients generally feel more comfortable receiving treatment in familiar, less institutional treatment settings -- because private practices could no longer absorb unreimbursed drug costs. They told us that they were unable to treat patients with the best available care because of patients’ inability to afford requisite out-of-pocket co-payments. They told us that they did not see how providers or patients or payers could keep pace with the escalating costs of new cancer therapies. They told us that their colleagues were retiring and their children were pursuing specialties other than oncology because both financial compensation and lifestyle were better in procedure-oriented fields.

Earlier Warnings of Cancer Drug Shortages? Alarm Bells Should Have Sounded 50 Years Ago

Right now in the US, over 40 million people are 65 years of age or older. And today -- right now -- we cannot meet the cancer drug demands of this age group. We cannot meet the demand for the wave of very expensive, new branded medications because the cost of these agents prohibits use for many patients. We cannot meet the demand for much cheaper generic cancer medications because -- among other reasons, some of which I addressed in a previous post about generic oncology drug shortages -- manufacturers do not get the financial returns to remain committed to continued supply.

To try to begin to remedy generic drug shortages that have already delayed care for many patients -- indeed, may already have led to preventable deaths -- President Obama signed an executive order earlier this week, directing the Food and Drug Administration to take action to reduce prescription drug shortages. The order instructs the FDA to do three things: broaden reporting of potential shortages of certain prescription drugs; speed reviews of applications to begin or alter production of these drugs; and provide more information to the Justice Department about possible instances of collusion or price gouging.

Generic Oncology Drug Shortage Means Unintended Healthcare Rationing

In cancer therapy, expensive drugs extend lives, while some cheap drugs save them.

Renowned oncologist and bio-ethicist Ezekiel J. Emanuel, MD, PhD inaugurated a regular New York Times op-ed gig earlier this month with commentary on generic cancer drug shortages.

Taking up a topic that has already been much discussed in both the professional media and the lay press, Emanuel observed that these drug shortages appear “to be the consequence of corporate decisions to cease production, or interruptions in production caused by money or quality problems, which manufacturers do not appear to be in a rush to fix.”

The gravity of this situation is widely acknowledged throughout the medical community. Dr. Hagop Kantarjian of the MD Anderson Cancer Center has gone so far as to observe that, in his opinion, the shortages of cytarabine have “affected life and death situations in the United States.”