Cancer Meds: Compliance or Manipulation?

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The Center for Health Transformation recently published a white paper on The Importance of Medication Adherence. In it, they report that as many as 40% of patients do not take their medications as prescribed, and up to 20% of new prescriptions given to patients by their doctors are not filled at all.

Research about medication non-compliance has reported three main reasons for it:


1.  lack of patient trust in the healthcare system,
2.  lack of patient education,
3.  and lack of funds.

This is actually an issue that I deal with almost every day in my job as a home care physical therapist. Here's a typical scenario. I visit a 72-year-old gentleman with a history of osteoarthritis and degenerative joint disease who has finally gotten around to having that miserable, worn-out knee replaced with a spiffy new prosthetic joint. His leg is swollen. He's been sent home with compression stockings, which are white elastic knee socks that help prevent blood clots from forming in his legs while he's not up to his usual activity. Typically, he's now taking three drugs that he usually does not take, to facilitate his recovery:

1.  a blood thinner, to further prevent the formation of blood clots, which are a particular risk after joint replacement surgery;
2.  an analgesic, narcotic pain medication like Percocet or Vicodin, which is given instead of a non-steroidal anti-inflammatory pain med, which you generally can't take with a blood thinner;
3.  and a stool softener or some form of mild laxative to prevent the constipation which is a side effect of analgesic drugs like Percocet and Vicodin.

Almost noone wants to take more medications. Almost noone wants to take Percocet or Vicodin. Almost everyone states concern over becoming addicted to narcotic pain meds.   So, I also usually explain to each patient that addiction to pain medication is very rare in this circumstance, because the medication has something legitimate to work on -- namely, pain.  When there is minimal or no pain, or if the medication is not effective, or if it's not taken consistently or at the recommended dosage, then there might be a risk for developing an addiction. I also explain that the medication should only be regarded as a tool, a means to an end, and that end is to enable a patient to do his exercises to regain his mobility, so that he won't need any pain medication anymore. The most important initial teaching I impart, however, is to instruct patients to obtain and use adequate cold packs, because I know from experience that if a person consistently wraps the entire surgical site with cold packs for 20 minutes, about every hour or two, he will have less swelling, less pain, more mobility, less risk for developing blood clots and infections, an improved healing process, and ultimately, less need for Percocet or Vicodin.

Most of the time, things work out.  People usually 'get it,' especially when they find out how much better they feel when they follow my advice. But sometimes they don't. In addition to constipation, drugs like Percocet and Vicodin can cause nausea, poor appetite, dizzyness, changes in blood pressure, and sleepiness. And sometimes they just don't work on a particular person's pain. People are hesitant to call their surgeon when their pain meds don't work or make them feel too sick. Then there are those few who are stoic, who think they are being heroic if they just put up with pain and don't take anything for it. To these, I explain that unrelieved pain robs their bodies of the energy they need to heal and get back to normal, that there is nothing to be gained by suffering, and usually a lot to lose. But the bottom line is that it's entirely up to the individual to decide whether he or she is going to follow my advice, or not. And often, people have good reason not to. Just last week, I had a patient in severe pain from a messy leg fracture, who tried to take the pain medication as prescribed, and who ended up in the ER with severe vomiting and dehydration from taking it. You'd think that with all the medications there are out there these days, it wouldn't be so difficult sometimes to help people feel better and to find the right combination of medications and treatments to prevent them from feeling worse. And you'd be wrong.

And then there's cancer.

Cancer treatment is a lot more complicated, expensive, and difficult than managing post-op joint surgery.   We all know how poisonous chemotherapy can be, and how certain damaging side effects like neuropathy can linger for a lifetime or even manifest themselves months after treatment, causing heart damage, pulmonary damage, cognitive impairment, and other assaults on the body. But many of us who are treated for hormone-positive cancers like breast cancer or prostate cancer are also prescribed oral chemotherapy after acute treatment is over, in the form of "hormone therapy," which we are expected to take for several years. It has become so commonplace for breast cancer patients with estrogen-positive tumors to be placed on oral medications that prevent or eliminate estrogen from circulating in our bodies, that we often don't think of it as chemotherapy. Which, in fact, it is. And as such, it is also comes with a full freight of side effects that can impair quality of life and cause serious health problems, including other cancers, that make compliance problematic.

A 2008 study in The Journal of Oncology Practice is just one of many to examine the reasons why breast cancer patients often do not comply with the full regimen of tamoxifen or aromatase inhibitors that are typically prescribed for five years. Reasons for non-compliance cited in the study include the expense of taking these drugs, a lack of full understanding of why they are prescribed, and concerns about side effects. This particular study examined programs that help improve drug compliance. They include things like providing information about financial assistance to pay for them, providing ample take-home educational materials, ensuring that refills are immediately available at a patient's local pharmacy, and providing quicker access to help by phone or by office visits when adverse side effects occur. The study acknowledged that, all too often, medical oncologists have not developed protocols for effectively helping patients on oral chemotherapy, and thus, are unavailable to address concerns, often referring patients to their primary care physicians to address symptoms that result from hormone therapy, but are not acknowledged as such.

Another review study, published this year by The Cochrane Library, an organization that attempts to provide "independent, high-quality evidence for health care decision making," examined Consumer-oriented interventions for evidence-based prescribing and medicines use. Sounds good on the face of it. The study reviewed 37 intervention programs to improve medication compliance among patients, across a wide spectrum of illnesses and treatments. Yet the authors concluded that none of the programs were universally effective, "rarely reported adverse events or harms," generally found a lack of evidence to demonstrate "important outcomes," and recommended further research.

Truth or dare?

One of the issues I have yet to see acknowledged or addressed in any of these studies is the lack of genuine informed consent, an issue that manifests itself as what I sometimes call statistical terrorism.   It has been my experience, as well as that of many others, that many oncologists quote statistics about the effectiveness of treatments or drugs that are taken out of context, never fully explained, nor personalized for the individual patient.

My own oft-cited experience with tamoxifen is a good example.    I was told, over and over, by my surgeon, my radiation oncologist and my medical oncologist, that I would reduce my risk of having a recurrence of breast cancer in the same breast by 50% if I took oral chemotherapy, i.e., tamoxifen or an aromatase inhibitor, every day for five years.    The discussion of potential side effects was cursory at best, and omitted several of them entirely.    When I began to develop serious side effects from tamoxifen, none of my cancer docs was readily available, and all that their nurses or assistants could offer over the phone was to make me an appointment for some rather distant date, like in three or six months, to come in and 'discuss' them.   Long story short, it fell to me, and my dogged pursuit of online research studies, to discover what was wrong with me.  I also discovered that the touted 50% reduction in recurrence risk was, in fact, a relative percentage, and that the actual reduction in my case was only 7.5%, or 50% of the 15% recurrence risk I was predicted to have if I didn't take the drugs at all.   This 7.5% figure was based on the pathological interpretation and statistical predictions for my type of cancer, its size, its histological type, its receptor type, its grade, and the treatment I'd already had for it.

It took me nearly a year to gather this information.  Many cancer patients don't know that it even exists.  In fact, had any of my doctors taken the trouble, the information was readily available from my pathology report, from the diagnostic and evaluative tools used by oncologists and pathologist to interpret cancer prognosis and risk, from the Van Nuys Prognostic Index used for Ductal Carcinoma In Situ, as well as in several research sources.    Meanwhile, I'd spent months being unable to work full-time anymore, barely able to keep myself supplied with trivial necessities like food and clean laundry, and experiencing a wretched combination of consuming fatigue, brain fog, joint pain, leg cramps, headaches, nausea, and a poorly controlled mood disorder.    In other words, my life was miserable, I was barely functional most days, and all to add 7.5% to the 85% probability that I wouldn't have a recurrence at all.   After eleven months, I finally got to see my med onc again, and I informed her that I had, not lightly, quit taking the tamoxifen, and that, when I began to feel much better after a week, wild horses wouldn't make me resume it now.   After due discussion, she agreed that I was better off without it.   Score 1 for quality of life.

Wild horses and peeing in a cup.

Then last week, another blogger posted the following little gem, which describes a study on how to improve compliance in breast cancer patients on hormone therapy.   The blog for Women At Risk, [WAR] a New York based program for women with breast cancer, run by the NewYork-Presbyterian Hospital/Columbia University Medical Center, posted an interview with one of its researchers, Dr. Alfred Neugut, about the study he was conducting with funding from WAR to improve hormone therapy compliance.   The purpose of Dr. Neugut's study is to develop a reliable urine test that will demonstrate the presence or absence of a hormone therapy medication in a breast cancer patient.   According to Dr. Neugut, results so far are as follows:

To date, we collected urine samples from 90 women who were supposed to be on hormonal therapy and found that 6% were negative. So, the test does find breast cancer patients who are misleading their oncologist. We have also studied four women who stopped their treatment at the end of the five years and determined that the urine test becomes negative 10-12 days after stopping the pills.[...]Ultimately, we will use the pilot data to justify and direct the use of the urine test in intervention trials used to increase adherence of hormonal therapy. If we can find ways to encourage women to continue on hormonal therapy, it would improve breast cancer survival.

Naughty, naughty!

Needless to say, I tried to post a comment.   I did refrain from including the remarks below about whether WAR's compliance program might include spanking women who didn't take their hormone therapy.  However, my slightly-more-polite comment never showed up.   Instead, the following day, I found one of those "mailer daemon" messages in my email inbox, followed by an automatic email generated by the apparent blog administrator, stating that she had left the organization a week after the interview with Dr. Neugut was posted.   Perhaps she left in disgust.   Instead, I was referred to various contacts should I have questions about WAR's programs or research, wished to make a contribution, or had general questions about future WAR events.

Well, this is one of the many reasons why I have my own blog.   So, here follows the unedited version of the comment I tried to post on WAR's blog:

I cannot even begin to tell you how profoundly disturbing yet illuminating I find this post about Dr. Neugut, his research, and the fact that you didn't even call him on any of his underlying assumptions.

The assumptions behind this study seem to be that we cancer patients are naughty children who need to be spanked and spied upon, that we don't have the right to make our own decisions, and that so-called 'hormone' therapy -- which should more accurately be called 'anti-hormone' therapy -- is completely necessary, 100% effective, and entirely safe.

As a health care clinician and breast cancer survivor, I'm appalled.  But I do thank you for providing this additional proof of the inappropriate and paternalistic arrogance that all too often resides behind the treatment recommendation our oncologists may make to us.  No need to provide informed consent, answer our questions or listen to our genuine and valid concerns.  "It's my-way-or-the-highway.  So quit your whining, toots, and if you don't go along, you'll get ten demerits, and I might punish you by finding something else to make your quality of life even worse."

Dr. Neugut, I refer you to a recent post on the Prepared Patient Forum, by Jessie Gruman, Ph.D., president of the research institute Center for Advancing Health, called Engagement Does Not Mean Compliance.   And I do beg you to recall that in health care, the bottom line is that it's the patient who has the right and responsibility to decide what treatment to have -- not the doctors or practitioners or even the patient's family members.  And it certainly isn't yours.  You ought to be asking your patients the reasons why we may stop hormone therapy.  You may be led to some fascinating and much-needed research about its risks and side effects -- like osteoporosis, uterine cysts, cancer related cognitive impairment, cancer related fatigue, the impact of cancer treatment on the survivor's ability to earn a living & avoid poverty, the impact of chronic pain on long-term health, or any number of relevant topics.  Shoot me an email, Doc.  We'll talk.

Meanwhile, could someone please tell the Dr. Neuguts of the world to spend more time informing and listening to their patients, rather than misleading them?

Related posts:

Blind-Sided: Cancer 101 & Informed Consent
The Numbers Game
Hormones + Breast Cancer = 'Spin'