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.

So What if Statins Increase Diabetes? The Real Risk May be Patient Non-Adherence

Just when we thought we had clarity on statin safety …

Last week’s leading health headline was a startling new finding that statin use increases the risk for diabetes mellitus (DM) in post-menopausal women by 50 percent, from six percent to nine percent.

While the data source -- the Women’s Health Initiative -- is an observational rather than a prospective study, the finding persists in a variety of patient subgroups, and even after the authors adjusted for baseline patient characteristics. This makes it unlikely that the increase in DM rate is due to women’s pre-statin risks of developing DM. Since diabetes is probably the single most important cardiac risk factor -- often considered the equivalent of a first MI in certain predictive models -- this news was both unsettling and perplexing. How might physicians and their patients interpret and act on this new information?

We were curious, so last week we conducted a small survey of full-time, office-based U.S. primary care physicians (PCPs) from the Epocrates physician panel* to test our hunches. Seven out of 10 PCPs had heard the recent mass media news coverage and, as a point of interest, two-thirds of them found the coverage “sensational” rather than “balanced/informative” -- despite the fact that clinicians interviewed on NBC Nightly News emphasized that they expected to keep their patients on statins.

Certainly, the news got patients’ attention. As of our survey date, at least one-third of PCP offices had received inquiries from statin patients. Balanced coverage or not, this sort of news event raises alarms, and it’s impossible for patients to draw implications on their own. What should patients, in fact, make of it?

Soda and Teen Violence: Hazards of Correlational Analysis Can Put Truth in Harm’s Way

Statistical Ammo for the Twinkie Offense: Guns Don’t Kill People, Soda Kills People?

No one with an interest in public health and a zest for social engineering can go wrong by criticizing soda. That particular cup runneth over with empty calories and plausible links to obesity, as well as tooth decay. The carbonated beverage industry is fighting a pitched battle in municipalities across the US to avoid punitive taxation meant to price soda beyond the reach of citizens who seem most at risk of making poor nutritional choices -- choices that ultimately all of us must pay for. No matter what you think of coercive taxation, it’s really hard to defend soda.

Now, though, thanks to research published by two Harvard-trained researchers, Sara Solnick of University of Vermont and David Hemenway of the Harvard School of Public Health, soda has come under another sort of fire.

An analysis performed on the Boston Youth Survey database shows a significant correlation between soda consumption and violence in teens, including a propensity to carry guns and exhibit violent behavior with partners. The paper, which appeared in the Journal of Injury Prevention, got a two-day flurry of press attention because it has a provocative thesis that keyed off the famous “Twinkie Defense.” It gives everyone even more reason to worry about what dangers may lurk in our refrigerators.

Or does it?