Compliance Or Manipulation?

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, quasi-narcotic pain medication like Percocet or Vicodin, which is given instead of a non-steroidal anti-inflammatory pain med because you generally can’t take them 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 Percocet or Vicodin. Almost everyone states concern over becoming addicted to them. 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 use their cold packs and do enough of their exercises so that they can walk around and get out of the house and drive again. 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, who don’t understand that pain robs their bodies of the energy they need to heal and get back to normal, and 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 nausea 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 wretched and poisonous chemotherapy can be, and how 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 breast 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 breasts and other tissues, 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. 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 the experience of many other people I know with breast cancer, that many oncologists are fond of quoting statistics about the effectiveness of treatments or drugs that are taken out of context and never fully explained or personalized for the individual patient.

My own oft-cited experience with tamoxifen is a good example. I was told, over and over, by all three of my cancer docs, the surgeon, the radiation oncologist and the 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 their nurses or assistants offered 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 simple math, using 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, which was already available both in my pathology file, 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 sucked, and all to add a lousy 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 informed her in no uncertain terms that I quit taking the tamoxifen, and that wild horses wouldn’t make me resume it. 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, a friend and sister 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, a New York based program for women with breast cancer, run by NewYork-Presbyterian Hospital/Columbia University Medical Center, interviewed 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 paragraph 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 was disgusted herself. I was referred to various contacts should I have questions about WAR’s programs or research, wish to make a contribution, or have general questions about future ‘events.’

Well, this is one of the many reasons why I have my own blog. So, here follows the unedited, snarky 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 women with breast cancer 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 utterly 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 make to us. No need to provide informed consent, answer our questions or listen to our genuine and valid concerns. It’s all “my-way-or-the-highway, lady. So quit your whining, and if you don’t go along, you’ll get ten demerits and I’ll 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 women 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.”

Believe me, I’m not done with this. I’ll find you, Dr. Neugut. I know where you work.

Related posts:
Blind-Sided: Cancer 101 & Informed Consent
The Numbers Game
Hormones + Breast Cancer = ‘Spin’

Please click on the post title or the comment link below to post a response.

This entry was written by Kathi, posted on Thursday, July 21, 2011 at 01:07 am, filed under Attitude, Chemotherapy-IV & Oral, Health & Healthcare, Research, Survivorship and tagged , , , . Bookmark the permalink . Post a comment below or leave a trackback: Trackback URL.

15 Responses to “Compliance Or Manipulation?”

  1. Naughty, naughty amazon. Don’t you know that women are just like sneaky little evil children?


  2. Another amazing article! We see it every day – women who were not informed that the pills they are being told they need would cause all these issues. People thought I was crazy for turning down Tamoxifen, but really, risk vs. side effects.

  3. Love this post! Interesting how medical oncologists can deceive women breast cancer patients, but it’s somehow not right for women to deceive the oncs?

    This is a brilliant posting that resonated with me. I was on Aromasin and told that “bone leaching” might occur, which sounded ominous, but I said that bone leaching was the lesser of two evils, the other one being a recurrence.

    I was in so much pain, I thought I’d die. The bone pain — I ached all over and could barely move without crying.

    The great thing is the my medical oncologist is really wonderful. He said, “This isn’t the right drug for you.” He was so understanding about my pain levels.

    Thanks for such an important posting; your work is always so informative and I’m reposting!

  4. I just took myself off of Tamoxifen after only 6 weeks of horrid side effects. I was doing some research when I came across several articles only mentioning it being good for ER+. Well, I am ER-, thus shouldn’t even be on it to begin with! My doctor decided that due to my age (35) it “wouldn’t hurt” to give it a try, but never bothered to tell me this. WTF?! I refuse to be miserable for 5 years for something that is not proven to work for ER- in the first place. Wonderful article – you definitely caught my attention!

  5. Kathi,
    Great post. There must be a collaborative effort between patient and doctor concerning all aspects of treatment, and this most definitely includes fully discussing, determining and evaluating the risks/benefits of drugs prescribed. Ultimately, the decisions are up to each patient to make, but they must become fully informed before making them.

    I also read the post by Dr. Neugut and I, too, was appalled. I cannot believe they are wasting time and RESEARCH dollars on developing a urine test to check up on women! I find this to be insulting, but more importantly a total waste of resources.

  6. Kathi,
    What an expose of the whole oncology profession! I had no idea they would be this sneaky in using urine tests for compliance purposes against our consent. We are not little children. I suffered much from being on Arimidex for six years. I believe I’m still dealing with its aftermath more than a year later.

    Lymphedema is even more about patient compliance once the clinical stage of treatment is completed. Therapists lecture and badger, but patients are the one who have to wash and roll bandages, exercise, stretch, massage and deal with hot compression garments day and night. After a year of this absolute nonsense I rebelled and didn’t look back.

    Good for you for stopping tamoxifen, and thanks for the eye-opening post!

  7. Kath,

    I read Dr. Neuget’s post. The fact that Women at Risk funded such an invasive action is sickening…..not to mention the nature of the research itself.


    And I agree: I’d leave my job after having to post that kind of interview as well.

    What we really need? Follow-up studies of 15-20 years of women prescribed hormonal therapies matched with pharmacy records. THAT kind of evidence would answer some of our questions.

    Thank you!

  8. Thanks, everyone!

    Christy, that is just stupid to prescribe hormone therapy for an ER negative tumor. Another thing that defies logic to me is insisting that women keep taking these drugs even after they’ve been talked into an oophorectomy. What tiny amount of estrogen is left after all that?? Do they think women are secretly taking HRT?? Good grief!

    Jody, we need more research as you described, and we need smarter drugs. I’ve so often said, estrogen is not the enemy — cancer is. There must be a way to develop more intelligent SERMS that can keep the estrogen away from breasts, but not leach it from all the other places where we need it.

    I’d also like to say I’m appalled at how casually some docs regard the entire issue of bone loss & osteoporosis from AI’s. My mother died of complications due to osteoporosis. Yes, died. And we are all of us at far greater risk for developing osteoporosis than most of us are for developing another breast cancer occurrence. Osteoporosis is a debilitating, wretched disease, and fractures cause tremendous pain & disability. My mother was so deformed by the 20 compression fx’s she developed in her spine (after going off HRT, with no other drug options then, and no follow up by her pcp), that her heart, lungs and intestines couldn’t function anymore & she died of that. I would not even consider aromatase inhibitors for that reason — I’m already osteopenic — but fortunately, I got no argument about that from my med onc. My next post…

  9. Kathi,
    Appalling study. Thank you for bringing it, and its many fallacies, into the open.

    Re: stats, my original onc told me, post-mastectomy, that I had a 44% chance of recurrence that endocrine therapy could drop by 17.1% and chemo by another 7%. No mention of Oncotype DX.

    Having read Dr. Susan Love’s Breast Book, I reread the info about genotyping cancers and demanded the Oncotype DX assay be run. Lo and behold, I had a recurrence score of 4 (with an estimated risk of recurrence of 4%). There was absolutely no point in chemo, which I verified by visiting a Top Doc at Barnes-Jewish in St. Louis.

    I’m currently on anastrozole without side effects but am thinking of going off. Why tempt fate with a drug that has not been studied long-term for a 2% bump in recurrence risk? The oncs I’ve dealt with simply do not help patients parse the research and statistics. Thank goodness I’m a researcher/writer professionally.

    Thank you again for your work in setting things straight.

  10. Wow, Chandra! Good for you for demanding that the oncotype test be re-run! That’s just incredible that, had you not done your own checking, you might have been put through all that pointless treatment. And yes, it helps to be a writer/researcher. If I hadn’t been myself, I might not have been able to wade through the info I needed. It makes you wonder if the some of the oncs bother to parse out this stuff themselves.

  11. Kathi,
    What a thoughtful activist you are. How I wish there were more clinicians like you who tell patients the straight scoop, encourage them to take their meds when necessary. Treatment and recuperation would be much easier. BTW, I’ve forwarded this on to an older friend who needs to read your wise words.

    Thank you,

  12. Such an informative post. Your point once again about the difference between ‘relative’ vs. ‘absolute’ statistics is crucial, as is the importance of oncotypes. One size does NOT fit all. Yet, so much in the cancer system functions as if it does. It’s appalling.

    And the urine test for drug compliance? The Women’s Health Movement fought against paternalistic medicine and made serious inroads. Now this?

    I agree with the comments that long-term follow-up studies are crucial for learning about ‘actual’ recurrence rates as well as the latent side effects of hormone drugs, that we must be our own advocates, that medicine must be tailored and evidenced-based, and that truly cooperative doctor-patient relationships are vital for obtaining quality care.

  13. Kathi, I’ve stayed on the tamoxifen, despite the issues, and the NCCN guidelines would put me in the “extended” category–to take 5 more years of an AI after 5 years of tamoxifen. And, my oncotype dx score is 12. So what’s my relative risk reduction vs. the side effects and hazards of an AI.

    I work in rad onc, and we treat male patients with prostate cancer with total androgen ablation, and 1) the lack of testosterone is treated like a terrible imposition and 2) it was being used widely, because urologists used to make a lot of money off of it, and recently as reimbursement changed, they revisted the studies which only showed benefit for high risk patients.

    I’ve seen an onc at Dana Farber who writes the adjuvant guidelines, and he’s wedded to them–he doesn’t see the patient, just the potential publication.

    If we’re “non-compliant”–it’s because we research the relative risk reduction, worry about the side effects of complete estrogen deprivation, and/or experience the side effects. The passive role of filling a script without question is not informed consent.

    I recently explained to a patient the etiology of her atrophic vaginitis on an AI, and I’m the first person to mention it–not her med onc, her gyn, her PCP, her breast surgeon. She thought she was nuts…

    Thanks for another great post.

  14. Judy, you know I love you. Your patients are lucky to have you. I wish I had a dollar for every time a patient said to me, “Why didn’t my doctor tell me that? Why is this the first time someone is telling me that?” And this is for a whole range of things, like using ice after joint replacement surgery, on up to much more thorny issues. I can entirely relate to that patient with vaginitis. That was one thing I didn’t have, but for the first year after diagnosis and treatment, suffering through the fatigue and side effects and not getting any better, I thought I was nuts, too. Sometimes I fear I’m too hard on docs and clinicians in this blog, but then I read crap like the study by this doc at Columbia/Presbyterian, and I don’t think I’m hard enough.

  15. Dr. Neugut needs to get put on an androgen inhibitor himself.

    Drug-screening cancer patients? Is this guy scared crapless at the idea of actually talking to his patients? No, wait, it’s the actual listening to patients that must scare him.

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