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.

FDA DTC and ROI: The simmering alphabet soup of pharmaceutical consumer outreach

The New FDA: champion of DTC and of survey-guided policy input

Just a few weeks ago, the FDA closed its public comments period on a questionnaire for a survey it intends to conduct later this year among health care professionals. The goal of the survey is to gather insight on how consumer-targeted promotion ultimately impacts the quality of interactions and decisions in provider offices around the country. The instrument itself is still a work in progress, and no one will be surprised to hear that our firm made a number of friendly, civic-minded suggestions. It’s clear that FDA has become a patron of survey research for many purposes -- policy development as well as risk surveillance.

The very fact that this particular survey is on the docket speaks volumes about what many FDA-watchers have already concluded: that the agency has morphed from wary and grudging to comfortable and upbeat about the benefit of allowing pharma to converse with patients. After several decades of experience, the FDA seems ready to conclude that direct-to-consumer advertising (DTC) can do more than bring relevant therapies to broader awareness. It can also, through “fair balance,” arm patients with many of the pros and cons to promote more informed conversation with caregivers. Actually, my husband (an attorney, not a citizen of our pharma community) has often expressed astonishment that any of my clients pay to run ads on TV because he is utterly convinced that they make patients run fast in the other direction. As it happens, he is mistaken.

Oncologists Answer the Question: What is an Added Month of Life Worth?

We recently surveyed U.S. oncologists in order to gain their perspectives on the emerging changes and challenges in the cancer landscape. The survey results spotlight an increasing tension between oncologists’ overwhelming optimism about the state of advancing science and their deep pessimism about the affordability of care.

One particular line of survey questioning addressed oncologists’ views of the value of incremental survival in the context of advanced cancer. We asked a series of questions designed to assess whether oncologists believe a new therapy that improves survival would be “worth it” under a variety of different contextual scenarios. Holding as a constant the assumption that the baseline price of the next best alternative care would total $15,000, we systematically varied: (1) expected survival time with the next best alternative care (either two months or nine months); (2) incremental survival with the new therapy (from one month to 12 months); and (3) the total cost of the new therapy (from $40,000 to $120,000 -- in other words, an increase in $25,000 to $105,000 over the cost of the next best alternative).

There are two key findings from those questions. First, in order for a majority of oncologists to declare the new therapy “worth it” even at the lowest of the prices we tested, the therapy must deliver a median of three additional months of life. Second, for the majority to judge those three additional months of survival an acceptable value, the cost of each additional month must be no more than roughly $9,000 to $10,000, regardless of whether baseline survival is two months or nine months.

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.

Universal Health Insurance Coverage -- Really?

"Universal" vs. "Coverage"

Yesterday, CNN’s Tim Langmaid reported that Health and Human Services estimates that the percent of insured young people aged 19 to 25 rose from 64 percent to 73 percent. Based on census figures, that percentage change represents about 2.5 million young people. The increase is attributed by some to a provision of the health care reform legislation signed into law last year that allows young adults to remain on their parents’ insurance plans through age 26.

Today, however, Sara Rosenbaum writes in The New England Journal of Medicine about the Douglas cases for which the Supreme Court heard oral arguments in October. These consolidated cases are comprised of suits against California Medicaid for cutting reimbursement rates to the degree that, plaintiffs argued, beneficiaries’ access to care was seriously threatened.

The question before the Supreme Court is all about legal standing in the shadowy ground between federal legislative authority and the role of the states. Does the U.S. Constitution give private individuals the right to go to court to halt state actions that violate federal law and threaten immediate and irreparable harm? This will be a key issue in the years ahead as the federal government and the states get set to squabble over who gets the last legislative word in the realm of public health and safety.

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.”

Helping Patients Assess the Benefits of their Drugs: Reading Inside the Box and Between the Lines on Drug Efficacy

Nothing creates advertising memes faster than DTC promotion – not even Super Bowl commercials – because health professionals and “civilians” alike take prurient interest in the conversation between pharmaceutical companies and patients. It’s not surprising, then, that Rx drug ads are both the inspiration for cultural jokes (can anyone look at a claw-foot bath tub without thinking of erectile dysfunction?) and the launch point for serious public health commentary.

Case in point. In a recent op-ed article in the NY Times, “Think inside the box,” authors, Steven Woloshin and Lisa M. Schwartz, two Dartmouth Medical School professors, urge use of patient Fact Boxes that feature not just drug side effects but also data on efficacy – which, in many cases, turn out to be less impressive than what optimistic patients imagine them to be. The presumption, which seems hard to refute, is that patients can make more educated choices about the risk-benefits of drugs when they know more – not just about the risks, but also about the benefits, or lack thereof.

The New “Political” Science: Avastin Breast Cancer Debate Exposes Paradox and Contradictions

The FDA’s recommendation to rescind Avastin’s metastatic breast cancer indication provoked a mix of commentary, commendations, and outcry from across the spectrum of stakeholders with an interest in the decision – and in what the decision might mean for the future: the future of cancer therapy approvals, evidence-based medicine, coverage for off-label use, drug pricing, and healthcare rationing … among other things.

This debate lies at the center of a tangled web of science, psychology, politics, economics, and ethics. Science and psychology, in particular, collide here in a way that reminds us of the challenge of selling the public on evidence-based medicine.

We are built by evolution to see cause-and-effect. The subset of women with metastatic breast cancer who have done well on Avastin almost cannot help but believe that they have done well because of Avastin. And it is no easy thing to overcome this built-in visceral conviction with the dry logic of rationality or the weight of evidence from patients treated in groups rather than as individuals.

Healthcare cost savings from expanded access to preventive medicine could be dead on arrival

Enormous, and enormously unrealistic, hope is being placed on preventing illness and its complications as a means to improving health outcomes and containing healthcare costs.

A major criticism of the U.S. fee-for-service healthcare model is that it rewards the treatment of health problems over their prevention. Much of the effort at reform is aimed at revising incentives to motivate providers to deliver preventive medicine.

The logic is that if physicians and other providers are compensated for a focus on prevention, and patients have access to affordable primary care, then people will be motivated to use that care and do the things needed to stay healthy. The reality, however, may be quite different.