Reducing Costs by Better Integration of Palliative Care in Cancer Treatment

We’re up to point 9 on the list – and nearing the end – on Bending the Cost Curve in Cancer Care from the May 26 NEJM. The suggestion from Drs. Smith and Hillner is that doctors better integrate palliative care into usual oncology care.

The authors start this important section well:

We can reduce patients’ fears of abandonment by means of better-integrated palliative care. This topic is fraught with misunderstanding given the references to “death panels” during the recent debate concerning health care legislation…

Here they’re on target: Some patients think, mistakenly, that inclusion of palliative care in their treatment means their doctors are throwing in the towel. I’ve known some oncologists who think the same, who perceive palliative care as a last resort.

The truth is that palliative care, which aims to relieve symptoms, can be implemented at any point in the treatment of disease.

The authors go on to provide data that cancer patients who receive palliative care live just as long, or longer, than those who don’t, and that their medical bills are lower. The issue I have here is their choice of emphasis on a published study of the Aetna Compassionate Care Program in which nurses identified patients for palliative care by administrative claims, “thus bypassing the oncologist.” Evidently this strategy led to a doubling of hospice referrals and other possibly good effects.

Besides that the cited study was authored by employees of an insurance company, which I find unpalatable, the concept of having nurses do the referrals deflects the issue: that oncologists talk about palliative care with their patients, directly. Relying on nurses to carry out these conversations would, understandably, contribute to a sense of abandonment, even if the nurses do the job perfectly. A critical role oncologists is to communicate about treatment care options, part of the cognitive work considered in point 8 of this discussion.

But the main idea, that doctors should integrate palliative care into their cancer patients’ treatment planning, earlier, and as a supplement – and not a replacement – for potentially curative or tumor-shrinking strategies, is right on.

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Reducing Cancer Care Costs: The Value of Physicians’ Cognitive Work

We’ve reached what may be my favorite of the proposed ways to reduce cancer care costs, published in the NEJM by Drs. Smith and Hillner. Idea Number 8 is to realign compensation to value cognitive services, rather than chemotherapy, more highly.

What the authors are saying is that we’d save money if oncologists were paid more for thinking and communicating, relative to their compensation for giving chemotherapy. They write:

Medicare data have clearly shown that some oncologists choose chemotherapy in order to maximize income for their practice.<46,47> A system in which over half the profits in oncology are from drug sales is unsustainable.

They suggest that physicians’ compensation should go up, relatively, for time spent

  • referring patients for participation in clinical trials;
  • discussing orders for life-sustaining treatments;
  • considering advance medical directives;
  • talking about prognosis in family conferences.

I couldn’t agree more.

Take the clinical trials example. In my experience enrolling patients in clinical trials, it was a lot of work if you (the oncologist) wanted to do it properly: You’d have to read through the entire protocol; identify any potential conflicts of interest, look up any other protocols for which the patient might be eligible and (ideally) offer that as well, take the time to explain that it’s fine for the patient to not enroll – that there’s “no pressure” (subject of a future post: when patients feel that they should enroll in their doctor’s trial), answer all of the patient’s and a family member or friend’s questions about it, process the paperwork carefully…

And I’d add to the authors’ suggestions for compensation-worthy time spent:

  • going over pathology results, carefully and with an appropriate expert (a pathologist), and discussing the findings with the patient or designated proxy;
  • reviewing radiology images with appropriate specialists (x-rays, CTs, MRIs… comparing each with the previous studies) and sharing the results, as above;
  • checking blood work; abnormalities can be subtle; trends not obvious if results aren’t charted over time;
  • discussing the patient’s condition, periodically, with other doctors such as the internist (or pediatrician), cardiologist, pulmonologist, surgeon, etc.
  • researching relevant published studies and case reports for puzzling clinical situations (using Google, Medline, a real library, maybe calling an expert at another medical center…)
  • communicating with patient about the condition, more generally (not only about end-of-life issues) – such as explaining  a tumor’s known or unknown causes, treatment options, genetic and other implications of a cancer diagnosis.

Bottom line:

When oncologists earn more money by prescribing treatments like chemotherapy, there’s a conflict of interest and a tendency to give more treatment. If oncologists’ salaries were set based on a case load, or time spent taking care of patients that includes cognitive services – thinking and communicating – patients would get better care and less unwanted treatment.

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Breast Cancer Avastin Update

This afternoon Ed Silverman of Pharmalot reports that Roche has proposed a compromise to the FDA over Avastin’s use in women with metastatic breast cancer. The drug would be approved for use only in combination with paclitaxel (Taxol), for which the data are strongest, and with special warnings.

He writes:

The deal includes revised labeling in which Avastin would be recommended only for patients displaying “aggressive disease” and who have the fewest treatment options. Roche also suggests a Risk Evaluation and Mitigation Strategy, or REMS, as well as a Medication Guide.

This sounds like a reasonable solution. As I have considered elsewhere, the FDA commissioner’s decision is pending.

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Implications of the Oncology Drug Shortage

Today’s New York Times features an op-ed by Dr. Ezekiel Emanuel, on the oncology drug shortage. It’s a serious problem that’s had too-little attention in the press:

Of the 34 generic cancer drugs on the market, as of this month, 14 were in short supply. They include drugs that are the mainstay of treatment regimens used to cure leukemia, lymphoma and testicular cancer.

Emanuel considers that these cancer drug shortages have led to what amounts to an accidental rationing of cancer meds. Some desperate and/or influential patients (or doctors or hospitals) get their planned chemo and the rest, well, don’t.

Unfortunately, what’s behind this harmful mess is neither a dearth of ingredients nor unsolvable problems at most of the manufacturing plants. Rather, the missing chemotherapies are mainly old and inexpensive, beyond their patent protection, i.e. they’re not so profitable, and not high-priority.

Emanuel proposes that the prices of old oncology meds – drugs that can cost as little as $3 per dose – be raised so that the companies will make it their business to provide them. This seems like a reasonable idea, although I find it a bit too compromising. Why should we raise the costs of any medications above what’s necessary for their manufacture and distribution?

The underlying problem is that we rely on a profit motive to deliver needed health care in the U.S. This kind of financial incentive, even if you find it morally acceptable, doesn’t seem to be working.

That’s why I favor scrapping the system – in which insurance companies siphon off some 30 percent or so of expenses, and pharmaceutical companies take another big cut – and giving patients the care they need, profits aside.

The health care reform bill of 2010 didn’t go far enough. Not even close.

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On Reducing Cancer Care Costs by Resetting Expectations, and Hope

Today we should move forward on the list published in the NEJM on Bending the Cost Curve in Cancer Care. We’re up to point 7 in our discussion, what’s 2nd in the authors’ proposed changes in attitudes and practice: “Both doctors and patients need to have more realistic expectations.”

This point follows closely from the previous, that doctors need to talk with patients earlier on end-of-life issues. But the central issue here is that most patients with cancer are unrealistic about their prognosis, and that oncologists do a terrible job in correcting their misperceptions:

…According to one recent study, most of the patients with lung cancer expected to live for more than 2 years even though the average length of survival is about 8 months.3

Resetting expectations will be difficult. Tools are available to help the oncologist provide truly informed consent by sharing anticipated response rates, chances of cure (always near zero for patients with metastatic solid tumors), and side effects…Many oncologists do not have these skills,43 so use of a decision aid may help…

What they’re describing amounts to Lake Wobegon effect, from the patient’s perspective, and that may be fair enough.

But I think these authors are letting oncologists off easy. Why it is that they lack “these skills,” i.e. what it takes to help patients face reality? It happens yesterday I was reading Dave deBronkart’s book, How to Laugh, Sing and Eat Like a Pig, on his experiences as a patient with metastatic kidney cancer, and he cites a terrific, pertinent excerpt in Dr. Jerome Groopman’s The Anatomy of Hope:

Hope, unlike optimism, is rooted in unalloyed reality. …Hope acknowledges the significant obstacles and deep pitfalls along the path. True hope has no room for delusion.

Clear-eyed, hope gives us the courage to confront our circumstances and the capacity to surmount them. For all my patients, hope, true hope, has proved as important as any medication.

Groopman’s point is that real hope rests in reality.

Going back to the NEJM piece –

I don’t think oncologists need (or better, should need) decision aids to help them reset patients’ unrealistic expectations. What they need is time, and thoughtfulness, and the capacity to be genuinely empathic.

If our health care system promoted trusting, and ideally longer, relationships of cancer patients with their physicians, patients would be less fearful of hearing the truth, and their doctors would be less afraid to speak honestly with them. This would reduce cancer care costs by lessening futile treatments, and would improve the quality of the patient-doctor relationships in oncology, besides the quality of care, in itself, and patients’ experiences as they near the end of life.

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NIH to Drop Requirement for Websites Disclosing Researchers’ Ties to Industry

sunshine image

Today’s word comes from Nature News that the NIH is dropping a proposed requirement for universities to disclose researchers’ financial ties to industry on websites. This is a loss for patients, who may not be aware of their doctors’ relationships with pharmaceutical companies and others who fund clinical trials, fellowships, conference junkets and other perks for physicians.

In 2010, NIH Director Francis Collins wrote: “As the nation’s biomedical research agency, the National Institutes of Health (NIH) must ensure that the research it funds on the behalf of US taxpayers is scientifically rigorous and free of bias.”

This sounds right to me, as it did to the folks at the health and safety arm of Public Citizen, according to the Nature report:

…a cornerstone of that transparency drive — a series of publicly accessible websites detailing such financial conflicts — has now been dropped. “They have pulled the rug out from under this,” says Sidney Wolfe, director of the Health Research Group at Public Citizen, a consumer-protection organization based in Washington DC. “It greatly diminishes the amount of vigilance that the public can exercise over financially conflicted research being funded by the NIH.”

As explained in the article, the proposal came about after evidence came to light that prominent NIH grant recipients had failed to inform their employers (universities and medical schools) about lucrative payments from companies that may have influenced their research. The problem now comes, in part, from lack of funding: the White House Office of Management and Budget (OMB) has no way to enforce the requirement.

That’s no surprise. But it turns out that academic groups lobbied against the requirement. According to the Nature News piece, the Association of American Universities and the Association of American Medical Colleges submitted a joint statement objecting that a website detailing physicians’ potential conflicts of interest (COI) would be onerous:

“There are serious and reasonable concerns among our members that the Web posting will be of little practical value to the public and, without context for the information, could lead to confusion rather than clarity regarding financial conflicts of interest and how they are managed.”

As a patient and as a physician who’s cared for patients in clinical trials and served on an institutional review board (IRB), I can’t be more clear in my thinking that the public should know about academic (and all) physicians’ ties with industry. Every institution with NIH funding should make this kind of information readily available and clear to patients. Otherwise, the faculty don’t deserve the NIH support they’re receiving for the research, nor do they deserve the public’s trust in their work.

Patients should be able to find this kind of information readily, before they enroll in clinical trials or decide to undergo any elective procedures, and even before they choose the physician who would guide them in health care decisions.

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Reducing Cancer Care Costs: Oncologists Need to Get a Grip on Reality, and Talk about Dying

We’ve reached the second half of our discussion on Bending the Cost Curve in Cancer Care. The authors of the NEJM paper, Drs. T. Smith and B. Hillner, go on to consider how doctors’ behavior influences costs in Changing Attitudes and Practice. Today’s point on the list: “Oncologists need to recognize that the costs of care are driven by what we do and what we do not do.”

In other words (theirs): “The first step is a frank acknowledgment that changes are needed.” A bit AA-ish, but fair enough –

The authors talk about needed, frank discussions between doctors and patients. They emphasize that oncologists/docs drive up costs and provide poorer care by failing to talk with patients about the possibility of death, end-of-life care, and transitions in the focus of care from curative intent to palliation.

They review published findings on the topic:

In a study at our institution of 75 hospitalized patients with cancer, the oncologist had initiated a discussion of advance directives with only 2 patients.31 In a prospective, multicenter study of 360 patients, only 37% of the patients and their families could recall having a discussion about impending death with the physician.32 Such a discussion is a prerequisite to good planning. Oncologists wait until symptoms appear or until they believe that nothing more can be done.33 In one study, at 2 months before their death, half the patients with metastatic lung cancer had not had a discussion with their doctors about hospice.34 This may explain why in a recent series the average length of stay in hospice for patients with lung cancer was 4 days.35

Although I have questions about the specific methods for some of these references, the bottom line is clear: Oncologists wait too long to talk with their patients about palliative or hospice care.

What they’re saying is that doctors need to get a grip on the problem (to overcome their denial and inability to talk about death), if they want to help patients come to terms with the inevitable. Doing so would save billions each year in the US, and would also spare patients from futile treatments and needless suffering.

I couldn’t agree more. It’s a potential win/win, if physicians think realistically about the situation and possible outcomes, and speak openly – and gently, no matter what, with their patients.

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Lowering Cancer Care Costs by Limiting Chemotherapy in Patients Who Aren’t Responding

This is the sixth post on Bending the Cost Curve in Cancer Care, based on the 10 suggestions put forth by Drs. Smith and Hillner in the May 26 NEJM.  We’re up to number 5 on the list for changing oncologists’ behavior: by limiting further chemotherapy to clinical trial drugs in patients who are not responding to three consecutive regimens.

They’re right.

Giving one drug or combination regimen, and then another, and another, and another, to cancer patients whose tumors resist multiple regimens is more likely to cause harm than good. Oncologists need be realistic with themselves and with their patients, in a kindly way, when treatments fail.

Options to consider, besides chemo, include palliation (which can be started at any time, including before and during chemotherapy), alternative approaches (such as hormonal or immune-based therapy, for some tumors), hospice care and participation in a clinical trial, as the authors suggest, based on the patient’s condition and preferences.

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The Big C: Cathy Goes For Treatment

In this week’s episode, Boo!, Cathy wakes up in the morning eager and ready to start treatment on a clinical trial. The day doesn’t go well – the local treatment center doesn’t have needed information about her insurance, which can’t be tracked down on time, her 15 year old son gets in trouble at school, and her husband loses his job.

That kind of day – when it seems like everything possible that can go wrong, goes wrong – will seem familiar to many if not all cancer patients. 

But the show continues to fail in providing any meaningful cancer information whatsoever. OK, I’m starting to accept the fact that ratings would suffer if the doctor gave even a 30 second mini-talk on BRAF mutations in melanoma. There will be no science on Showtime. But the scriptwriters could, at least, have included the discussion of the doctor and Cathy’s signing informed consent for the trial. There’s not a word about what treatment she’s getting, or what the shots she took in the last episode were for.

You’ve got to wonder if Laura Linney’s character, the “patient,” understands the purpose of the trial she’s on, the nature of the experimental treatment and risks.  The FDA approved Yervoy (ipilimumab) for patients with advanced melanoma months ago (considered here). Did her oncologist offer her that drug and, if so, why did she choose the clinical trial? Might the oncologist have a conflict of interest, in regard to the research? Is Cathy enrolled in a Phase I, II or III trial?

Please tell me something about her treatment! So far I see the Big C as a lost opportunity for teaching about cancer medicine – through humor and the potential talent of a terrific actress, or about meaningful and realistic patient-doctor relationships, or about informed consent.

If I hadn’t said I would follow the show and post on it this season, I’m not sure I’d bother watching it any further.

But I’m a compulsive sort of doctor-blogger-patient: I’ll keep watching it, at least for this year’s episodes, and I’ll keep you posted, in case you care about Cathy’s predicament, or if you want to share her thoughts on the show.

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Reducing Cancer Care Costs: Why Not Offer Neulasta in Smaller Vials?

This is the fifth in a series of posts on how we might reduce the costs of cancer care, based on 10 suggestions offered in a May, 2011 NEJM sounding board. We’re up to point 4:  oncologists should replace the routine use of white-cell-stimulating factors with a reduction in the chemotherapy dose in metastatic solid cancers.

In this section, the authors allude to what I think might be a cost-saving advance in oncology practice: why not make available lower doses of white blood cell (WBC) colony stimulating factors?

The issue is this: when people get high doses of chemotherapy, they’re compromised because the bone marrow doesn’t create new WBCs as it should. The risk of infection during chemo used to be so great that, in the 1980s and earlier, it was common for cancer patients to succumb to infection. With the advent of WBC stimulants in the early 1990s, the risks of infection during chemo dropped markedly.

These are complex and expensive drugs. And while I agree with the NEJM authors that chemotherapy is over-used, often, I don’t think it makes sense to cut down on potentially helpful doses or combinations of those drugs just because WBC stimulants are expensive.

Take Neulasta (pegfilgrastim), a long- acting stimulator of neutrophils manufactured by Amgen. This injectible drug costs over $ 2,000 for a single, 6 milligram vial. It’s supposed to be given every 2 weeks, although some oncologists might give it at a lesser frequency, depending on the chemo cycles. There’s only one size dose available for all patients; they’re all billed for the full 6 milligrams.

This is an ideal situation for Amgen, which takes in over $2000 for each 6 milligram vial. It’s far from perfect for patients who, even if there’s no toxicity, pay huge co-pays with each chemo cycle.

You can find some patients’ discussions of this issue at cancer support sites like these. There’s also a public correspondence between Medicare and the State of Wisconsin on the high costs of this drug.

Around 10 years ago, when I was practicing, I wondered why we couldn’t give some patients less than 6 milligrams of Neulasta. This would be useful in at least three situations: for patients who are physically small; for those who receive lower doses of chemo; and for people who are hyper-sensitive, for whom just a tiny bit is enough to raise the white count adequately. A frequent toxicity is bone pain; this is intense in some patients and, in theory, would be less problematic if a lower dose were available. Once, I almost got into administrative trouble for asking a pharmacist to draw up only half of the dose from a vial so that I might give a petite woman only 3 milligrams of this powerful drug.

Since then, nothing’s changed. I looked it up yesterday; there’s still only one dose of Neulasta: 6 milligrams.

So if Neulasta were sold in lower-dose vials, like 1, 2, 3 or 4 milligrams, patients could receive lesser doses, as is often appropriate. The costs of these drugs, when administered properly, might be halved, approximately, without compromising on recommended doses of chemotherapy.

Just my two cents, nothing more –

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Reducing Costs by Holding Back on Chemotherapy for Cancer Patients Who are Frail

This is the fourth in a series of posts on Bending the Cost Curve in Cancer Care, by Drs. Thomas J. Smith and Bruce E. Hillner, in a recent NEJM health policy piece. The authors’ third suggestion: to limit chemotherapy to patients with good performance status, with an exception for highly responsive disease, is surely one of the most controversial.

What they’re suggesting is a simple rule: “Patients must be well enough to walk unaided into the clinic to receive chemotherapy.” There are necessary exceptions, they point out, such as cancer patients disabled by another medical condition but who otherwise can carry out daily activities with relative normalcy. (I’ll offer an example: say a 50-year woman with multiple sclerosis who is wheel-chair bound but otherwise essentially well; she would be a candidate for treatment in this scenario.) But in general the authors would hold off on chemotherapy for cancer patients with a limited performance status  – a measure that oncologists use to assess how well, or disabled, a person is in their capacity to work, perform ordinary daily activities and care for him or herself.

I’m not sure I agree with the “walking” threshold, or ECOG performance status 3 or below, as the authors describe: “meaning that they are capable of only limited self-care and are confined to a bed or chair more than 50% of waking hours.” These criteria are subjective and problematic. But I do think the authors are onto a central, unavoidable issue in reducing health care costs. That is by limiting care, i.e. by rationing.

For elderly patients with cancer, especially for those who have significant other illnesses, it may not be appropriate for doctors to give chemotherapy and other, non-palliative cancer treatments. The authors don’t (dare) advise a particular age cut-off for therapy; they suggest using performance status criteria. They conclude this section of the paper on cutting cancer care costs with this statement:  “Implementation of such a simple threshold could dramatically decrease the use of chemotherapy at the end of life.”

The authors are right, that we (oncologists and other doctors) shouldn’t be in the business of routinely giving aggressive treatments to patients who are very old and frail, who are more likely to suffer harms of treatment than potential benefits. Not just because we can’t continue driving up U.S. health care costs indiscriminately, but because when very frail, elderly patients are given chemotherapy they’re less likely to recover after treatment. By not saying “no” to patients who are too fragile for a requested intervention, or by simply treating patients who are so feeble or demented, or both, that they’re unable to say “no” for themselves – such as sometimes happens in nursing homes and other chronic care facilities, doctors may cause more harm than good.

Some readers of this blog may be wondering how I can reconcile this position with what I’ve said about access to Avastin for women with advanced BC. In my opinion, patients’ age and, broadly, their functionality – if they can think and communicate seems at least as relevant as whether they can walk – should be factored into the risk/potential benefits analysis of almost any medical treatment.

So if we’re going to consider restricting cancer drugs and interventions based on cost, indirectly or overtly, we should account for patients’ ages, the potential length and quality of life to be gained: If there’s a 50 year old patient who might benefit from a costly cancer treatment, it’s likely that person will benefit more from that drug than would a 70 year old patient, or a 90 year old patient. It’s also more likely, but not a sure thing, that a younger, otherwise healthier patient will tolerate a given treatment with fewer side effects.

Hard to know where and how to draw the lines.

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Reducing Cancer Costs by Giving One Drug at a Time, Sequentially

This is the third in a series of posts on Bending the Cost Curve in Cancer Care, based on the late-May NEJM health policy piece.

Today we’ll consider the second of the authors’ suggestions: to limit second and third-line treatments to sequential monotherapies for most solid tumors. This particular suggestion, one of the few proposed with which I disagree, falls under the rubric of how oncologists’ behavior might be modified. The authors write:

A Cochrane meta-analysis showed that combination therapy had a small advantage over single agents for first-line therapy but caused more toxicity, and the review left unresolved the question of whether sequential single agents were a better choice.

…patients will live just as long but will avoid toxic effects. Second, society will benefit from cost reductions associated with less chemotherapy, fewer supportive drugs, and fewer toxicity-associated hospitalizations.

This approach is tempting, cost-wise, but may be simplistic: The purpose of combination chemotherapy is to give agents that work additively or synergistically, typically each at a lower dose, to achieve more effective treatment. In cancer, the best-studied multidrug regimens are in lymphoma, leukemia and breast cancer. Similar principles apply to antibiotic regimens for some infectious diseases, such as the drug “cocktails” for HIV or tuberculosis.

It could be that the authors are right for certain agents and some tumor types. But, likely, some drugs, including new targeted treatments given to patients who’ve already had several treatments, may be most effective and, paradoxically, less toxic – because the dose of each drug can be lower. The likelihood of resistant clones emerging may be diminished, too.

The problem we’re left with, of course, is that testing the different combination regimens will be costly. But I wouldn’t assume it’s better or necessarily cost-effective to give cancer drugs one at a time.

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Patients’ Words, Unfiltered, Medical Journalism and Evidence

Yesterday’s post was not really about Avastin, but about medical journalism and how patients’ voices are handled by the media.

L. Husten, writing on a Forbes blog, cried that the press fawned, inappropriately, over patients’ words at the FDA hearing last week, and that led him to wonder why and if journalists should pay attention to what people with illness have to say, even if their words go against the prevailing medical wisdom.

There’s a fair amount of controversy on this. For sake of better discussion in the future, I think it best to break it up into 3 distinct but inter-related issues:

1. About health care journalism and patients’ voices:

A general problem I perceive (and part of why I started blogging) is how traditional medical journalists use patients’ stories to make a point. What some of my journalism professors tried to teach  me, and most editors I’ve dealt with clearly want, is for the reporter to find a person with an illness, as a lead,  and then tell about the relevant news, and provide some expert commentary – with at least one person speaking on each “side” of the issue, of course – and then end the story with some bit about the patient and the future.

I argue that this form of medical journalism reduces the patient to an object, used by the story-teller in order to capture the reader’s attention. So, with exceptions and always with the person’s consent, I prefer to offer my own story, from my perspective, so as not to use the patient as a vehicle or literary device.

So it appears that Husten is OK with using patients’ voices to tell a story (and sell papers/clicks?), but not with presenting their views unfiltered if they don’t mesh with the party line or a particular point an editor wants to make. This lies at the center of the journalism issue.

(As an aside, a few recent published studies have found value in analyses of patient-reported symptoms, unfiltered even by their doctors.)

2.  About Avastin:

My impression is that some beast cancer advocates, including a National Breast Cancer Coalition representative who spoke at the FDA hearing, have chosen to “take the hit” on this particular issue because they need and want to appear rational. The straightforward-seeming argument is that the data show Avastin doesn’t work and is often harmful, so it shouldn’t be FDA-approved for women with metastatic BC. From the perspective of a BC advocacy group, it may not be worth pushing for a drug that helps only around 5% of patients.

The problem is there’s no biomarker for Avastin responsiveness, because this drug doesn’t target a particular genetic marker. Rather it works by cutting the blood supply, which could vary even within a particular patient’s mets in different organs. The only way to test if Avastin works in a patient is to give the drug, with informed consent, and see how it goes. Unlike, say, a bone marrow transplant, which runs in the range of hundreds of thousands of dollars and, once done, is irreversible, you can give one dose of Avastin and stop it, or two and stop it, if it doesn’t work or it is not well-tolerated.

Based on my experience as an oncologist and patient who’s received some risky interventions, I don’t think Avastin is more toxic than many or even most cancer drugs. Rather, its side effects have been heavily pushed by the media and public health/epidemiology academics in the past two years, who perhaps wish to make a larger point about this costly drug and evidence based medicine (EBM).

3. About evidence-based medicine: I’m in favor of EBM, especially in principle. The problem is that published medical data is too-often flawed and also, that some patients are, really, outliers.

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No Room For Emotion or Exceptions to the Rule (on Avastin)

My cousin testified before the FDA oncology advisory board on Tuesday about her experience taking Avastin. This is a tragedy, to deny the only drug that is keeping a 51 year old woman alive.

image from p.3 of today’s NYTimes business section

You have to wonder, are the advisory panel members so rational in all their behavior and choices? Are they always so razor-like in their oncology decisions?

Unlikely.

These experts have an agenda, here: It’s to be perceived as scientists, even when their knowledge is imperfect and exceptions to the rule stand right in front of their eyes. But clinical medicine calls for flexibility, and tailoring of treatment to each case, and caring about each person, including those who fall at the tail, or in this case better end, of any Kaplan-Meier survival curve.

What would Larry Kramer do about this, I’ve been thinking: He’d scream, really loud, so loud he might break his eardrums. He’d wonder why others, affected and near, aren’t doing the same. And he’d understand why this picture is on page 3 of the business section, and not on the front cover; it’s because people don’t want to look or see or know or think about it too much, because it hurts.

That is the normal heart, and this is a normal response to what’s happening to women with metastatic breast cancer.

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Lowering Cancer Care Costs by Reducing Tests After Treatment

This is the second in a series of posts on Bending the Cost Curve in Cancer Care. We should consider the proposal, published in the NEJM, gradually over the course of this summer, starting with “suggested changes in oncologists’ behavior,” #1:

1. Target surveillance testing or imaging to situations in which a benefit has been shown. This point concerns the costs of doctors’ routinely ordering CTs, MRIs and other imaging exams, besides blood tests, for patients who’ve completed a course of cancer treatment and are thought to be in remission.

The NEJM authors consider that after a cancer diagnosis many patients, understandably, seek reassurance that any recurrence will be detected early, if it happens. Doctors, for their part, may not fully appreciate the lack of benefit of detecting a liver met when it’s 2 cm rather than, say, just 1 cm in size. What’s more, physicians may have a conflict of interest, if they earn ancillary income by ordering lab and imaging tests.

My take:

It’s clear that some and possibly most cancer patients get too many and too frequent post-treatment surveillance tests. Believe it or not, yours truly, whose life was saved by a screening digital mammogram, maintains a healthy fear of excess radiation exposure. I agree to x-rays, CT scans, myelograms and whatever else my doctors suggest only when I’m reasonably confident that the test result would influence a treatment decision.

My impression is that, in general, oncologists’ habits of ordering routine, interval-based imaging for patients in remission after cancer treatment (such as a scan every 3 or 4 or 6 or 12 months) are arbitrary and unsupportable by any published data. These sorts of practices, which vary among communities, arise like this: A senior, smart and well-intentioned oncologist at a major teaching hospital, circa 1990, orders newfangled CT scans of the chest, abdomen and pelvis on his lymphoma patients every 4 months for two years, and then every 6 months for two years, and then every 12 months, for no reason other that he thinks it’s a good idea. The patients like it; they’re reassured, and he (the oncologist) feels good about having prescribed the drugs that caused their sustained remission.

Talk about a positive feedback loop! (We needn’t even invoke financial incentives as a motivating force.) And then that’s just how it’s done by all the fellows he’s taught over the years, who then branch out into other communities and even other countries, and teach…

Why not?

Now things may be changing a bit, as patients like me are starting to fear radiation exposure, and also are starting to question doctors’ recommendations more than they did even a few years ago. Younger doctors, too, have more requirements to continue their medical education in order to keep practicing at most hospitals and maintain their board certificates, and so they, too, may be more questioning of these archaic practices.

About post-treatment screening with scheduled blood work, I see this issue somewhat differently than do the NEJM authors, mainly in that I’m optimistic about simple blood tests, in the future, that may provide affordable and clinically relevant information to patients who’ve undergone treatment with tumors at high risk of recurrence.

As the authors point out, there are some old tests, such as CEA screening, that can be helpful in monitoring for recurrence in patients with a history of colon cancer. In general, blood tests are less dangerous and less expensive than imaging studies. Besides, in patients with aggressive tumors that might respond to new targeted drugs, tests that measure circulating tumor cells (CTCs) in small blood samples, and could assess cells for new mutations, at low costs in the future (not now), might render some blood tests useful and even cost-effective, in the future.

Finally, I’d like to throw in a concern I have about some clinical trials, in case any study designers or persuasive cancer IRB members happen to be reading this post:

Some of the clinical trials for new cancer drugs may require too many follow-up MRIs, CTs and other scans. Even if Pfizer or any other company foots the bill, by participating in the trials patients shouldn’t be subjected to excessive radiation or even just the unpleasantness and hassle of a said-to-be-safe test like an MRI. This pet peeve is especially concerning in some trials requiring multiple post-treatment PET scans, the most rad-intense of common imaging methods.

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Don Berwick, Head of CMS, on the Value of Patient-Centered Care

A few weeks ago I had the opportunity to hear Dr. Don Berwick speak at the annual meeting of the Association of Health Care Journalists.

Berwick now heads the Centers for Medicare & Medicaid Services. When he spoke in April, on transparency and how we might simultaneously cut costs and improve care, I thought his talk was pretty good. This morning, through Twitter, I came upon a short clip from a Berlin conference in 2009. Here, he tackles the meaning of patient-centered care. It’s near-perfect:

Don Berwick, on YouTube: What Patient-Centered Care Really Means

My favorite lines:

…The errors and unreliability of health care are not the main reason that I fear that inevitable day in which I will become a patient…I can use my own wit to stand guard against them…

<rather>

…What chills my bones is indignity. It is the loss of influence on what happens to me. It is the image of myself in a hospital gown, homogenized, anonymous, powerless, no longer myself. It is the sound of young nurse calling me “Donald” which is a name I never use, ‘It’s “Don.’…

It is the voice of the doctor saying ‘we think,’ instead of ‘I think,’ and thereby placing that small verbal wedge, the pronoun ‘we,’ between himself as a person and myself as a person…

Bravo!

Why I like this clip so much is that Berwick gets the nuanced language of medicine in a way few doctors, in my experience, do. He’s not so much afraid of data and making decisions or even errors, which are in theory surmountable problems, through better information and education, and despite everything may not lead to a “cure” or even a person’s survival, per se. He most fears being perceived as an object, without respect for his concerns and preferences.

That is my greatest fear, too.

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Running 2 Lists That Might Lessen the Costs of Oncology Care

Recently the NEJM ran a Sounding Board piece on Bending the Cost Curve in Cancer Care. The authors take on this problem:

Annual direct costs for cancer care are projected to rise — from $104 billion in 20061 to over $173 billion in 2020 and beyond.2…Medical oncologists directly or indirectly control or influence the majority of cancer care costs, including the use and choice of drugs, the types of supportive care, the frequency of imaging, and the number and extent of hospitalizations…

The article responds, in part, to Dr. Howard Brody’s 2010 proposal that each medical specialty society find five ways to reduce waste in health care. The authors, from the Divisions of Hematology-Oncology and Palliative Care at Virginia Commonwealth University in Richmond VA, offer two lists:

Suggested Changes in Oncologists’ Behavior (from the paper, verbatim – Table 1):

1. Target surveillance testing or imaging to situations in which a benefit has been shown.

2. Limit second-line and third-line treatment for metastatic cancer to sequential monotherapies for most solid tumors.

3. Limit chemotherapy to patients with good performance status, with an exception for highly responsive disease.

4. Replace the routine use of white-cell-stimulating factors with a reduction in the chemotherapy dose in metastatic solid cancer.

5. For patients who are not responding to three consecutive regimens, limit further chemotherapy to clinical trials.

Suggested Changes in Attitudes and Practice (same, Table 2):

1. Oncologists need to recognize that the costs of cancer care are driven by what we do and what we do not do.

2. Both doctors and patients need to have more realistic expectations.

3. Realign compensation to value cognitive services, rather than chemotherapy, more highly.

4. Better integrate palliative care into usual oncology care (concurrent care).

5. The need for cost-effectiveness analysis and for some limits on care must be accepted.

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For today, I’ll leave this provocative list without comment except to say that it should engender some long and meaningful, even helpful discussion.

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Give Doctors a Break

In a heartless op-ed in yesterday’s paper, an anesthesiologist argues that medicine shouldn’t be a part-time endeavor. Dr. Sibert makes a firm introduction: “I’m a doctor and a mother of four, and I’ve always practiced medicine full time,” she boasts. “When I took my board exams in 1987, female doctors were still uncommon, and we were determined to work as hard as any of the men.”

Her premise:

With a growing shortage of doctors in America, we can no longer afford to continue training doctors who don’t spend their careers in the full-time practice of medicine.

She’s half-right, I think; the costs of medical education are too great for doctors to be pulling back on normal work hours or quitting their work entirely, willy-nilly. Besides, perhaps a tougher or more persevering group of would-be physicians might have used their coveted med school slots to better end and, ultimately, helped greater numbers of people.

The problem is this: What happens when a doctor gets sick? Or her child? Or partner or spouse? Most of us who’ve gone to med school, men and women both, do or should plan for coping with the inevitable decline of our parents and older family members. But there are some unfortunate circumstances that can make full-time work a challenge for months or even years.

I suspect the author has been fortunate in her career and health.

When a doctor or a dependent becomes seriously ill, she needs a supportive environment. She needs a workplace that allows her to take time off completely, or to work part-time for a while and possibly for a period of years, in a way that doesn’t engender resentment among her colleagues.

In a system without slack, doctors may feel pressured to work under too much duress, when they themselves are facing serious health or family problems. As things stand, I’ve witnessed doctors who’ve abused alcohol, been unkind to colleagues and disrespectful toward patients, and cut clinical corners as ways of coping with too much work, too little free time, and too little sleep.

Sometimes, the reasons why a doctor needs to cut back on her hours or work may not be evident to her colleagues. She may keep her good reasons to herself. With patients, explaining the details of one’s own illness, or a child’s, seems unprofessional, in general, although I do think that when a doctor becomes so fragile that she may not be able to return to work, her patients have the right to know that much, if they depend on her.

As for me, what I’ll say here is this: The day I stopped practicing medicine, nearly five years ago, was one of the saddest days of my life.

Medicine still is a macho field, as Dr. Sibert reveals in her op-ed. This is a shame, because the physicians’ shortage is real. In the long run, the system – which amounts to doctors in supervisory positions, like division and department chiefs – should soften up.

A flexible, more realistic system would allow doctors, in whom the system has invested so much, and who have invested so much of themselves, to take time off when they need it, and flexibility in their schedules, so they can continue in their careers after prolonged illness.

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Considering Aromasin for Healthy Women, and the New Breast Cancer Prevention Study

I’m minding the annual meeting of the American Society of Clinical Oncology from a distance this year.

So far, the big breast cancer story syncs with a NEJM paper published yesterday on-line, on the use of exemestane (brand name: Aromasin, manufactured by Pfizer) to prevent invasive breast cancer. These patent-protected pills block the body’s normal production of estrogen.

The main finding was that for women deemed “at risk” for developing BC – as defined by the investigators – the incidence of cancer was significantly reduced when they took Aromasin as compared to a placebo. At a median observation point of 35 months, there was no observed effect on the women’s survival.

What’s right about the study: it’s prospective, randomized and large, including over 4560 women. The results are clear in terms of percents and relative risks: There was a 65% relative reduction in the annual incidence of invasive breast cancer (0.19% vs. 0.55%) and a hazard ratio of 0.35 (with confidence interval 0.18 to 0.70; P=0.002). So they’ve got strong stats.

Estrogen, typically depleted but not absent in post-menopausal women, can promote growth of breast cancer cells. From the paper’s first section: “Aromatase inhibitors profoundly suppress estrogen levels in postmenopausal women and inhibit the development of breast cancer in laboratory models.” So the findings are plausible, which helps, too.

The first problem (or non-problem, really) is there were only 43 cases of invasive BC in total; there wasn’t much cancer, or its reduction, in either arm of the study in terms of absolute numbers. This makes the divergent percents reported seem far less impressive. Second, and more importantly – the long-term consequences of taking this relatively new estrogen-inhibiting drug, in terms of women having thinner bones, possibly more cardiovascular disease, diminished libido and other side effects, are unknown.

Already there are two drugs marketed to prevent breast cancer in some women: tamoxifen and raloxifene. These drugs, also anti-estrogens, have significant side effects including blood clots, and few women choose to take them as prophylaxis for breast cancer. The new study suggests Aromasin is better because it’s got fewer side effects; Pfizer’s idea is that it’s a safer option for women who want to reduce their risk of developing BC.

But what caught my attention is who qualified for this trial: Most healthy women over the age of 60 – that’s a whopping, growing population of potential Aromasin-takers, besides the relatively small number of women with known pathology such as precancerous or stage 0 breast cancer (conditions like LCIS and DCIS, for which a preventive drug seems justifiable) or high risk-conferring BRCA-1 or -2 mutations.

Reading over the trial’s eligibility, I had to wonder, how could anyone think it reasonable to treat all women over the age of 60 with an estrogen inhibitor? And who populated the IRBs that approved this protocol? (Imagine if oncologists were to propose testing the effects of chemical castration in thousands of men over the age of 60; few would support such a trial, although in all likelihood androgen ablation would reduce the incidence of prostate cancer in men.)

The NEJM article lists support for the work from the Canadian Cancer Society Research Institute, the Canadian Institutes for Health Research, Pfizer, and the Avon Foundation. Among my many questions, I’d like to know what exactly what fraction of the study’s support came from Pfizer. The Journal (and every) should break this down for a published non-advertisement: If Pfizer provided 5% or 50% or 95% of funding for the trial, readers should be informed, as should women who might choose to take this drug and their doctors who might prescribe it.

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News on Niaspan, Cholesterol Drugs and Biomarkers

The Times alerted me, this evening:

Lowering bad cholesterol levels reduces heart attack risks, and researchers have long hoped that raising good cholesterol would help, too. Surprising results from a large government study announced on Thursday suggest that this hope may be misplaced….

Common wisdom has been that such patients should take a statin drug like Lipitor or Zocor to lower bad cholesterol and, in many cases, the vitamin niacin to raise their good cholesterol. But in the trial, niacin provided no benefit over simple statin therapy.

It wasn’t clear to me which was the study, but Bloomberg News explains:

Niaspan failed to prevent heart attacks and may have boosted stroke risk in a U.S.-funded study that calls into question the benefit of raising good cholesterol to combat the leading cause of death.

The National Institutes of Health said today it stopped a 3,414-person study early after the addition of Niaspan to simvastatin, a standard therapy for high cholesterol, was linked to strokes in 1.6 percent of patients, compared with 0.7 percent in the control group. The combination failed to reduce heart attacks, heart-related hospitalizations and the need for procedures to reduce chest pain and restore strong blood flow.

So Niacin, what’s supposed to lower triglycerides and raise HDL – the “good” cholesterol – turns out to be a bust, at least when it’s given in the form of Abbot’s Niaspan.

As to how well cholesterol levels reflect a person’s real risk for heart and other vascular disease, I’ve been skeptical for years.

blueberries with oatmeal (at breakfast this morning, with a bit of grapefruit juice nearby, photo taken by sheer coincidence)

Still, I have faith in oatmeal, with skim milk and fruit, for breakfast.

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