PROFITS vs. Patients in the escalating battle to conquer cancer

The high costs of cancer drugs puts them out of reach for many patients.

The high costs of cancer drugs puts them out of reach for many patients.

Beyond the caring rhetoric carefully crafted by providers of cancer treatment and therapeutics, there exists a motivation every bit as powerful as saving lives — reaping billions of dollars in profit. That’s what is at stake in the ongoing war on cancer — a war in which important battles have been won, but at a tremendous cost.

As the number of cancer patients grows and their treatments become increasingly expensive, we will find ourselves locked in an unwinnable war of attrition…unless reining-in costs becomes as much of a priority as expanding our medical armamentarium.

How the battlefield changed:

Despite the fact that cancer incidence rates have declined for the most frequently occurring types of the disease, cancer continues to impact 40 percent of all Americans, and it is responsible for 20 percent of all deaths. That translates into 1.66 million newly diagnosed patients annually and nearly 600,000 deaths, according to the National Cancer Institute. Incidence tells only part of the story, however. More importantly, the majority of cancer patients are surviving longer.

There are currently more than 14 million Americans who have survived cancer—a dramatic increase from the 3 million survivors in 1971. While much of this increase is attributable to population growth, improvements in cancer therapies have also played an essential role. As a result, for many patients, cancer has been transformed from a death sentence into a chronic disease that perhaps cannot be cured, but can be controlled for an extended period of time.

The soaring costs of care:

Fifty years ago, direct spending on cancer care equaled $1.3 billion. By 1995, spending had soared to $41.2 billion, and by 2010, it was an estimated $125 billion. That’s an almost 10,000 percent increase in direct spending over fifty years. Add in the indirect costs of care, such as lost productivity, and the numbers almost triple.

Cancer care was not the only part of the nation’s health care bill that rose dramatically over time. In 1950, total health care costs for the U.S. equaled $12.7 billion. By 2012, those costs had risen to $2.6 trillion – a 20,000 percent increase in the span of three generations

Such costs have taken quite a toll. Today, the single greatest cause of personal bankruptcy in America is medical bills. In fact, “The percentage of personal bankruptcies in the United States attributed to health care costs rose from 46.2% in 2001 to 69.1% in 2007.” Such statistics come as no surprise, since patients are bearing an increasing proportion of the cost burden associated with expensive treatments. Medicare beneficiaries who are often on a limited, fixed income are particularly hard hit.

What Lies Ahead:

The estimated cost burden for the coming decades is fuzzy at best. The NIH guesstimates that the direct costs of cancer care could range anywhere from $158 billion to $207 billion. A number of factors are contributing not only to cost escalation, but also to the complexity of forecasting.

We know that the projected level of growth in the 65+ segment of our population—which is the segment most affected by cancer—will result in a virtual tsunami of cancer patients. What we don’t know is how these patients will be treated, or the costs of emerging therapeutic modalities.

Furthermore, with the number of cancer survivors forecast to grow to 19 million by 2024, there will presumably be a dramatic increase in the long-term costs of controlling their disease and maintaining their well-being.

History demonstrates that the cost of cancer does not increase linearly, but rather in a manner reminiscent of Moore’s law—a factor that proves beneficial when describing the growing power of computers, but not the growing costs of care. Nowhere is this more apparent than in the skyrocketing costs of pharmaceutical products.

A Pharmaceutical Gold Rush

The pharmaceutical industry has doubled-down on its investment in cancer therapeutics—a wise move, considering the increased market demand reported by industry monitor, IMS:  “The global market for oncology drugs, including those used in supportive care, reached $91 billion in 2013…this compares with $71 billion in 2008 and $37 billion a decade ago.”

With demand soaring and sales burgeoning, much of pharmaceutical research now centers on beating cancer. IMS concluded that, “cancer therapies account for more than 30 percent of all preclinical and phase I clinical development products…”

It’s not just demand that is driving the soaring sales of cancer drug. It’s the manner in which drugs are priced. In the U.S., which accounts for 40 percent of all cancer drug sales, there are no governing rules regarding pricing, beyond what the market will bear. While most consumer products are priced based upon comparative value, the price of cancer therapeutics appears to be plucked from the ether with no relationship to the drug’s relative efficacy or toxicity.

Don’t take my word for it, look at the numbers: According to an article in the Journal of Clinical Oncology, “Of the 12 anticancer drugs approved by the FDA in 2012, only three prolonged survival, two of them by less than 2 months…yet nine were priced at more than $10,000 per month.” One drug, approved for the treatment of pancreatic cancer, was shown to extend survival by a mere 10 days.

According to an article published by the Mayo Clinic, “Last year, ipilimumab (Yervoy; Bristol-Myers Squibb, New York, NY) was approved by the Food and Drug Administration (FDA) for the treatment of metastatic melanoma. The benefit in survival over and above standard treatment was 3.7 months in previously treated patients and 2.1 months in previously untreated patients. The cost: $120,000 for 4 doses.”

It appears that $100,000 per year has been set as the minimum threshold for introducing new cancer therapies.  But it is not just the introductory pricing of drugs that is problematic. It is also the price inflation of cancer drugs that is raising costs astronomically. The price of imatinib, a drug used to treat CML (chronic myeloid leukemia) increased from $30,000 to approximately $90,000 over a ten-year period.

Lies, Damn Lies, and Statistics:

The pharmaceutical industry justifies what appears to be morally egregious behavior by explaining that drug costs are primarily driven by research costs. In fact, stating that the cost of bringing a drug to market now exceeds $1 billion has become almost a mantra—but it is patently invalid.

Pharma’s argument regarding the tremendous costs of research was effectively eviscerated in a November 15, 2013 article in the prestigious journal Cancer.  Authors Donald Light, Ph.D., and Hagop Kantarjian, M.D., demonstrated that the actual cost probably approaches $125 million or one-eighth of what has been claimed.

You Don’t Have to Sell Drugs to Profit from Cancer:

It’s not just pharma that is profiting from this gold rush.  Cash-strapped hospitals and health systems are lining up to ensure that cancer provides a rosy bottom line for their institutions.

Not only are facilities expanding the depth and breadth of cancer services offered, but they are now employing oncologists at an unprecedented rate. Such employment accomplishes multiple objectives: 1) It locks in the physicians who control patient flow in the market, thus locking in market share; 2) it allows the hospitals to increase the costs of the oncologists’ services by billing them as hospital outpatient services; 3) it allows hospitals to capture all the procedural revenue—imaging, radiation, and surgery—associated with these patients; 4) it allows hospitals to increase profits on the resales of cancer drugs using what is known as “340b” pricing.

Numerous other parties stand to profit handsomely from the growth of cancer—including, but not limited to health information technology companies that seek to capitalize on the tremendous data-demands associated with cancer research, medical technology vendors, and even manufacturers of prosthetics.

Re-establishing equilibrium between Patients and Profits:

Until payers realign incentives so that providers are rewarded based upon achieving the most efficient and effective patient outcomes over time, there will be an imbalance between the needs of patients and the pull of profits.

There are specific steps that can be taken today to achieve these objectives, including:

  • Physicians must act as fiduciaries for their patients’ health and well-being. As such, they must demand comparative effectiveness data that show the relative value of a cancer drug. Physicians can drive change simply through their prescribing patterns, and they must wield this power appropriately on behalf of their patients. This principle was proven effective when a group of oncologists at Memorial Sloan Kettering refused to prescribe the drug Zaltrap because it was twice as expensive as an alternative drug yet no more effective. The manufacturer bowed to the pressure and cut the price of Zaltrap by 50 percent.
  • The FDA can aid these efforts to move from “what the market will bear” pricing to value-based pricing by establishing minimal thresholds for comparative efficacy while also factoring in the comparative toxicity of drugs under consideration. .
  • There must be clear and unequivocal prohibitions on any conflicts of interest that allow physicians to profit, beyond their professional fees, for the provision of cancer therapeutics—be it a chemo agent, radiation treatments, or other modalities.
  • The Department of Justice must bring greater scrutiny to the acquisition of major oncology groups or other actions that may result in the creation of monopolies or oligopolies in cancer care.
  • Congress must reconsider the prohibitions on governmental agencies, such as Center for Medicare and Medicaid Services (CMS), from negotiating prices with pharmaceutical manufacturers.
  • As a society, we must struggle with through discussions of what we are willing to expend in order to extend life, while factoring in the patients’ probable quality of life. Discussions of “death panels” must yield to rational, albeit difficult conversations.

The Time to Act is Now:

 Health care providers and vendors have proven that they are incapable of being self-regulating. They have also proven that they are subject to the same moral vices as the rest of society, including greed. There needs to be immediate action to stop the profiteering off the backs of cancer patients, while war of attrition, simultaneously using our health care dollars wisely in the quest to conquer cancer.

 

PLEASE VISIT THE WEB-SITE FOR MY NEW BOOK, After You Hear It’s Cancer: A Guide to Navigating the Difficult Journey Aheadwww.afteryouhearitscancer.com  

 

Taking Your Foot off of the Accelerator

shutterstock_105707267_Slow

For Recently Diagnosed Cancer Patients and Their Families

There is one piece of advice that Lori and I offer without equivocation to newly diagnosed cancer patients – slow down…take your foot off of the accelerator, and realize that you have begun a journey not a sprint.  Though certain diagnoses mandate prompt action, it should never be at the expense of level-headed thinking that leads to a clear understanding of your options.

The Role of a Caregiver

Your first order of business is to identify a caregiver, often times a family member, who will accompany you on your journey. There will be moments when you are unable to process important information about your diagnosis and treatment.  That is when your caregiver becomes your scribe – taking notes, recording comments, doing whatever is necessary to retain critical data to help you make informed decisions.

The Right Care Team

The second order of business is to ensure that you are enlisting the right health care resources to give you the optimal chance of a positive outcome.  Your cancer care team will likely include a multi-disciplinary array of providers. Physicians, like all human beings, vary significantly in their knowledge, competency, experience, and interpersonal style. Since you are entrusting your health to these individuals, you should get to know them, and feel comfortable with them.

As part of this process, you need to also consider the health system with which your doctors are affiliated. Health systems, too, vary dramatically in their capabilities. If you have a complicated diagnosis or a difficult condition to treat, some systems may be better suited to meet your needs, such as National Cancer Institute (NCI) affiliated centers or more sophisticated community cancer centers.

Understanding Standards of Care

Next, it is imperative that you understand your diagnosis. For virtually every diagnosis, there is a standard of care – pathways that define the optimal methods for treating a disease at different stages of development.  As a consumer, there are tools that describe many of these care pathways. You can find them online at www.ncccn.org/patients/.

You will quickly discover that there are often multiple options or pathways for treating your disease. Different treatments may be equally effective in controlling or eliminating your cancer, but vary in other important ways. Take the treatment of Stage 1 breast cancer for instance. A lumpectomy followed by radiation has the same statistical likelihood of curing your cancer as a mastectomy, but is far less invasive, requires little to no reconstructive surgery, costs less, and involves a far shorter recover. Yet, for some very legitimate reasons, many women still opt for the mastectomy. There’s not a right or wrong decision…as long as the patient is truly informed as to the options and trade-offs.

Seeking a Second Opinion

Once your care team has provided you with a diagnosis, including the location, stage, and grade of your cancer, as well as treatment recommendations, it’s time to consider a second opinion. A second opinion may be less critical for early stage cancers that are easily treated than for complicated diagnoses. A second opinion should provide peace of mind that a proper diagnosis has been rendered and appropriate treatment options explored.

When seeking a second opinion, we advise people to consider consulting with a new team of physicians at a different health system. Once again, an NCI-designated center may be a great option if available in your area. Prior to arranging the second opinion, be certain that you have all of your medical records, including diagnostic imaging and other tests, readily available for the consulting physicians.

Discernment and Prayer

Once you have the requisite information about your condition and recommended treatment in-hand, it is time to think carefully about everything that you have heard. Use your caregiver, family, and friends as a sounding board as you work through the best options for you.  Once you have discerned the answer, you can put your foot gently back on the accelerator, and pray for a safe journey ahead.

All of these topics are covered in far greater detail in After You Hear It’s Cancer: A Guide to Navigating the Difficult Journey Ahead, available at Amazon.com.

 

Can Health Care Handle True Innovators?

Solutions to health care's plethora or problems require unique thinking.

Solutions to health care’s plethora or problems require unique thinking.

Imagine that you are scanning through resumes of your latest job applicants, and you come across an individual whose job history includes: university professor, healthcare executive, consultant, professional photographer, karate instructor, advertising executive, executive coach, and author? Would you discard it out-of-hand concluding that the applicant was a wacko malcontent or would you say, “Wow, a renaissance man?”

While the average American will change jobs 11 times over his or her lifetime, rarely do such changes involve complete reinvention of one’s career. Such tectonic shifts in our professional lives are understandably pathologized by a society that rewards stability, and frowns on unpredictability.

Yet, far from being pathological, such shifts may identify individuals motivated by a profound need for meaning in their lives rather than by the rewards associated with climbing the corporate ladder. Though such individuals may grace an organization but for a short time, if properly managed, their positive impact can be profound.  After all, if they can successfully reinvent themselves on numerous occasions, imagine what they can do relative to innovation in your corporation!

So what traits do these professional shape-shifters have in common? Here’s a list – what’s important here is to know what your organization can and cannot live with before bringing this rare creature on-board:

#1: Innovators have difficulty following standards pathways or protocols…preferring to intuitively seek out more efficient or effective ways of managing challenges. Their solutions are often far outside the box.

#2: Innovators are relatively intolerant of organizational resistance to change –neither understanding nor appreciating the value of an organization’s muscle memory. They are the antithesis of the legions of Six Sigma black-belts of whom your organization may be so proud. Innovators are the employees who will poke management with a sharp stick if they fail to get the response they seek.

#3: Innovators are relatively fearless when it comes to change…change is as natural a part of their lives as breathing. Their worth and identity is not tied to the current job…it is based upon where they are at in their existential search for meaning.

#4: They do not suffer fools well…and can exhibit amazing impatience when they perceive that they are dealing with ignorance.

#5: They may disregard corporate protocol as being superfluous and annoying…including such things as chain of commanded.

#6: They may not filter what they say or how they say it. After all, it is the truth, from their perspective, and, as such, needs not to be framed or apologized for.

#7: They do not revere loyalty in the traditional sense. You won’t be rewarding these innovators with a gold watch after 30 years of service. The most you can hope for is to part company as valued colleagues…and wish the innovator well as he or she moves on to yet another reinvention.

Such individuals need to have a culture that can embrace and adapt to their idiosyncratic nature. Many of these traits are immutable, though good innovators can be coached on how to get their ideas across in a semi-politically astute manner.

If you can create the right conditions for such an innovator, you should expect:

  • The potential for radical, out of the box thinking that will outstrip any linear planning processes currently in place in your organization
  • The potential for vision that seeks possibilities previously completely oblique to your organization and leadership team.
  • Ways of creating synergies that were not previously identified
  • The ability to challenge and catalyze positive change in your corporate culture
  • The ability to attract great talent to your team

Where do you find such individuals?  First, you have to open your eyes to the possibilities. One of the most innovative thinkers I ever hired was a gentleman applying for a copy-writing position with my company. Though he had never been in such a position before, he proudly proclaimed that he would be, in short order, the best copywriter in town. His resume was eclectic, to say the least…including past job jobs as an exterminator and manager of a low-income housing project, while also having earned a Ph.D, and being honored as a Fulbright Scholar. What matters most is that he lived up to his boastful claim – he became a superlative writer with highly innovative ideas.

I am writing this post because I work in the health care arena, where transformational change often times seems to be an oxymoron, and problems are resolved at a glacial pace.  I’m convinced that, if we are to address the plethora of complex issues that keep our health care system from delivering safe, affordable, high quality care, a good starting point would be to replace our black-belts with new true innovators…and then step out of the way and empower them to work their magic.

When Hope at the End of Life Transcends Mere Words on a Page

iStock_000015624872MediumSometimes writing has a strange way of foreshadowing life.

The past six months have been marked by an almost constant struggle to shape an unwieldy manuscript on hope at the end of life into something manageable and hopefully meaningful. I finally relinquished the tug-of-war last week, albeit temporarily, to catch my breath, regain my wits, and presumably gain perspective by achieving some distance from the tough topic that I’d chosen for my next book book. Yet, the topic seems now to be choosing me.

In the past 48 hours, there have been two, life events that have required my wife and me (and our family) to hold onto hope at the end of life.

The first occurred when my wife’s brother was admitted to the hospital with a life-threatening pulmonary embolism. Since Lori is the physician in the family, the situation necessitated her frequent consultation, albeit at a distance of over 1,000 miles. Thank goodness other family members were able to be at his bedside, despite having to travel long distances, while also managing the ongoing realities of their lives.

Simultaneously, another family member, suffering from a stage 4 brain tumor, became critically ill as a result of his disease. As a cancer physician, Lori has navigated the fine line that separates life and death with an untold number of patients and their families as they search for a glimmer of hope under the sterile glow of the ER’s fluorescent lights…but this was different…it was intensely personal.

48 hours, two events, and life is inevitably changed forever. Hope at the end of life is no longer an intellectual concept safely ensconced in my manuscript. It has leaped from the pages into the present moment. It has brought prayer to our lips for those whom we love.

The family is blessed to have a strong sense of faith. Yet even the strongest faith doesn’t remove the sharp sting of loss. As we enter the week, we will hold on to the hope that our family members are in God’s hands, and that, whatever the outcome, they will comforted by his grace, as will those who love them the most.

John Leifer’s Recent Radio Conversation with a Physician About the Myths of Modern Medicine

On The AirDr. James Mirabile was kind enough to have me as a guest on his hour-long radio program on 3/14/15.  We discussed some of the key themes found in The Myths of Modern Medicine: The Alarming Truth About American Health Care. 

I would invite you to spend a few minutes listen to the podcast…and then I would, as always, welcome your thoughts & comments!

Here is the link:

http://stationcaster.com/player_skinned.php?s=1071&c=19373&f=4130253

PS: You can order The Myths of Modern Medicine on Amazon.com.