IBD, Stephen Hawking and Nice

You have by now all read of the very funny folks at Investors Business Daily thought England’s NHS was so awful that a poor soul like Stephen Hawking would be long dead had he to depend on those slugs in England for his care.

Just in case you missed it, here’s the correction:

Editor’s Note: This version corrects the original editorial which implied that physicist Stephen Hawking, a professor at the University of Cambridge, did not live in the UK.

But, enough hilarity. If you read the rest of IBD’s editorial, you might notice their attack on England’s National Institute for Health and Clinical Excellence (NICE), an arm of the NHS, for its ruthless analysis of the cost and effectiveness of drugs. The bastards!

Anyway, the editorial contains this sentence, “In March, NICE ruled against the use of two drugs, Lapatinib and Sutent, that prolong the life of those with certain forms of breast and stomach cancer.” This is interestingly the exact same sentence that appeared in a WSJ op-ed on July 7th. But it’s a beautiful sentence. Who can blame IBD?

IBD also has this gem: “The British are praised for spending half as much per capita on medical care. How they do it is another matter. The NICE people say that Britain cannot afford to spend $20,000 to extend a life by six months. So if care will cost $1 more, you get to curl up in a corner and die.”

I can just see the clinicians and scientists at their final meeting, throwing patients under the bus for that dollar/pound. Bastards! The corollary to this, when you think about it, is the pharmaceutical company not lowering the price for the wonder drug by this apocryphal dollar. Bastards!

But what about these heartless beasts at NICE and these wonder drugs the British public is being denied.

From the NICE report on Lapatinab for breast cancer:

Clinical Benefit Rate
Using the independent assessment a greater proportion of subjects in the lapatinib + capecitabine group (29%) than in the capecitabine group (17%) achieved clinical benefit (odds ratio: 2.0, 95% CI: 1.2, 3.3, two-sided p-value: 0.008; cut-off date 3 April 2006). Using the investigator assessment of the clinical benefit response rate a greater proportion of subjects in the lapatinib+capecitabine group (37%) than in the capecitabine group (21%) achieved clinical benefit (two-sided p-value: 0.001).

Duration of Response
For subjects who responded to treatment, the median duration of response was 32.1 weeks in the lapatinib+capecitabine group and 30.6 weeks in the capecitabine group.

Get that? They are being denied a drug that increases the median duration of response by a staggering 1.5 weeks for the additional 12% who had some response to treatment!

The same paper included an analysis of a study on brain metastases that showed no significant difference in outcomes there, either.

Don’t get me wrong. I am all for research and pushing the envelope. Continuing to study these drugs is fine, as long as all the appropriate ethical guidelines are followed, particularly with regards to real informed consent. But arguing on the basis of a study as described above that this should be placed into mainstream use is ridiculous.

My other pet peeve about these types of treatments is the cruel, false hope given to so many patients as they are offered “the next” chemotherapy regimen, intensive care, and so on.

I also have no objection to choosing to continue these treatments to the bitter end, as long as one understands the choice. I often get patients on “salvage” chemotherapy, palliative chemotherapy or palliative radiation treatments who don’t understand what those terms mean. Maybe they were too rattled when the discussion took place and simply don’t remember. But my experience with these patients and their families is that the discussion never took place in earnest.

Being told that the cancer has come back or spread to your brain or whatever and that here’s what we can do next is far different than having a really hard conversation about your prognosis and all of your options.

Maybe your options are 2 or 4 or 6 months with “salvage” chemo if things go well (or a much more abrupt end if they don’t!) versus 1 or 3 or 5 months without, but at home, having your symptoms aggressively managed by a palliative care specialist and working with hospice for a peaceful dignified end. And more than likely the 2 or 4 or 6 months with aggressive treatment means a lot of that time spent in the hospital, dying in an intensive care unit, hooked up to life support until someone finally tells you, too late, the hard truth.

Let’s not kid ourselves about this disturbing side of American medicine: our often mindless devotion to doing “everything” up until the nails are being hammered into the coffin is, more often than not, in stark contrast to doing “the best things” for our patients.

AMNews: May 14, 2007. Battle over futile care erupts in Texas … American Medical News

AMNews: May 14, 2007. Battle over futile care erupts in Texas … American Medical News:

Disability rights and pro-life activists are pushing for changes in Texas law that would force physicians and hospitals to provide life-sustaining treatment indefinitely in medically futile cases.
Under an advance directives law hammered out by medical, disability and pro-life groups in 1999, the families or proxies of patients on life support have 10 days after hospital officials formally notify them that they plan to withdraw treatment to find another facility to care for the patient.
But the Terri Schiavo controversy and a number of heavily publicized cases in which Texas families scrambled to transfer their loved ones and sued hospitals to continue treatment have taken place since then. Bills now being considered in the Texas Legislature would eliminate that 10-day time limit. A measure in the 150-member House has garnered 80 co-sponsors.
The Texas Medical Assn. argues that these so-called treat-until-transfer bills would force doctors to continue treatment in cases when it’s medically inappropriate and that further intervention inflicts pain on patients without any corresponding medical benefit.
The Texas law, which applies only to terminally ill patients with an irreversible condition who are unable to make their own health care decisions, is also unusual because it requires the hospital’s ethics committee to review any medical futility case before the 10-day clock starts ticking. While hospitals in other states usually review any decision to withdraw care, such procedures are not legally required. Virginia is the only other state to place a time limit, 14 days, on how long an effort to transfer the patient must continue before life support is withdrawn.
Texas hospitals have used their state’s advance directives law 27 times to withdraw treatment over family objections, said Robert L. Fine, MD, one of the 1999 law’s architects.

Although, as the article points out, AMA ethics policy is consistent with this approach, I am surprised that it has ben used so often in Texas. But then, this is the death penalty state, and so, I suppose we shold not be surprised.

I can’t see doing this, personally, but I can tell you that the irrationality of some families is impenetrable, and the strain on ICU staff – which should count for something – in engaging in what most of us would consider behavior tantamount to cruelty leads to early burnout of some very fine individuals for no benefit other than the acquiescence to this irrationality.

BTW, the law was not updated and stands as it was.

The Associated Press: Long lines as free health care offered in LA area

The Associated Press: Long lines as free health care offered in LA area:

The Los Angeles event marks the first time Remote Area Medical has provided such medical care in a major urban area. The medical group typically serves patients in rural parts of the United States and travels to underdeveloped countries.

The piercing sound of teeth being drilled and scraped echoed up to the rafters where the Los Angeles Lakers once played to the roar of capacity crowds. Mobile health trucks provided other medical examinations, and tables full of donated eyeglasses were available to those who had eye examinations done.

Since 2000, The Forum has been owned by Faithful Central Bible Church, which donated the use of the facility for a week. The medical professionals volunteered their time and covered their own liability. Cash and services were donated by local hospitals, health systems and charitable groups.

Tennessee-based RAM’s founder Stan Brock said he helps organize 30 to 40 such health care events a year, with a total of 567 events held to date, adding: ‘We just wish we could do more.’

‘This need has existed in this country for decades and decades,’ said Brock. ‘The people coming here are here because they are in pain.’
The event came at a time when the national debate over President Barack Obama’s health reform plan has boiled over at town hall meetings, with opponents sometimes shouting down Democratic members of Congress who favor the program.
Rep. Maxine Waters, D-Calif., told a cheering crowd of volunteers and medical professionals at The Forum that she would continue to advocate for health care reform because ‘we can do a better job of providing health care to those who desperately need it.

Let’s see, 567 events times maybe 500 people each, how many anecdotes is that?

Health Care in Germany

Health Care in Germany:

This is from a British source, The Institute for the Study of Civil Society

First, Germans are free to visit any doctor they like. They may either walk in off the street, or ring for an appointment that will invariably be booked for the same morning or afternoon. Consumers can and do penalise bad service. Our recent study of German consumers commonly produced reactions like this: ‘I saw a long queue, so hopped on the tube and went to a different practice’; ‘she was rather ill-tempered so I never went back’; ‘the facilities were drab, so I went to a different one next to my office’; ‘I felt rushed at his practice so didn’t go back’.

Second, Germans do not have to see a GP before visiting a private specialist. GPs do act as gatekeepers to German hospitals, but about half of all specialists practice outside the hospitals. German hospitals provide few out-patient services. Instead, there are a large number of independent clinics, invariably with the most sophisticated diagnostic equipment. Most Germans have a favourite GP, although many maintain a relationship with more than one – just in case – but if they need to see a specialist they would not waste time seeing a GP first.

Third, there are plenty of specialists. Germany has 2.3 practising specialists for every 1,000 people, compared with only 1.5 in the UK.

What problems are there in Germany? The German media is not excited by the subject. There are no patients lying on trolleys in A&E. Germany suffers no real rationing. Yes, problems occur from time to time. Just at the moment, there is a shortage of nurses, and many Germans feel that care is expensive, but serious complaints are few. Nevertheless, reform is in the air. Since January 2004 members of the statutory insurance plan have had to pay 10 euros per quarter to see a GP.

The reforms also saw the introduction of charges for non-prescription drugs, and an end to free treatments such as health farm visits and to free taxi rides to hospital. This is expected to allow for a reduction in premiums from an average of 14 to 13 per cent of annual gross wages.

German satisfaction rates in 1996, the latest Eurobarometer survey, showed that the German are far more satisfied with their system than we are with the NHS. About 11 per cent of Germans said they were ‘very or fairly dissatisfied’, compared with 41% per cent here. And when asked whether their system needed ‘fundamental
changes’ or a ‘complete rebuild’ 19 per cent of Germans said ‘yes’, compared with 56 per cent of Britons.

Does the German healthcare system deliver an acceptable standard of care for serious illness to all members of society? Do the poorest in society benefit from a higher standard of healthcare provision than those in the UK? The answer to both of these questions is an emphatic, ‘yes’.

Rationing? Say it ain’t so!

Blue Cross praised employees who dropped sick policyholders, lawmaker says – Los Angeles Times:

But documents obtained by the House Committee on Energy and Commerce and released today show that the company’s employee performance evaluation program did include a review of rescission activity.

The documents show, for instance, that one Blue Cross employee earned a perfect score of ‘5’ for ‘exceptional performance’ on an evaluation that noted the employee’s role in dropping thousands of policyholders and avoiding nearly $10 million worth of medical care.

WellPoint’s Blue Cross of California subsidiary and two other insurers saved more than $300 million in medical claims by canceling more than 20,000 sick policyholders over a five-year period, the House committee said.

‘When times are good, the insurance company is happy to sign you up and take your money in the form of premiums,’ Stupak said. ‘But when times are bad, and you are afflicted with cancer or some other life-threatening disease, it is supposed to honor its commitments and stand by you in your time of need.

‘Instead, some insurance companies use a technicality to justify breaking its promise, at a time when most patients are too weak to fight back,’ he said.

Lawmakers — Republicans and Democrats alike — decried the practice of canceling policies of ill policyholders and grilled insurance executives about it.

Medicare’s ‘No’ on Virtual Colonoscopy Stirs Expert Debate – Forbes.com

Medicare’s ‘No’ on Virtual Colonoscopy Stirs Expert Debate – Forbes.com

Just a marker for when the topic comes up. basically Medicare, for the first time, has indicated that the evidence for virtual colonoscopy is not yet adequate to warrant reimbursement at this time. This will be reconsidered if new evidence accumulates.

It’s worth saying that this is how medicine should work, but it has become a favorite piece of evidence for Sen. Tom Coburn that the world of American Medical Paradise is coming to a totalitarian halt.

Researchers do studies to evaluate treatments, medications, etc., and when a significant amount of evidence accumulates, the treatment enters general use.

Sad part is, this works exceptionally well when procedures are involved because of the fee basis for physician reimbursement and the lopsided reimbursement that hospitals and surgery centers receive for procedures.

It doesn’t work so well getting new methods of medically managing patients out into standard practice. This is what Comparative Effectiveness Research should help. Finding out wht works and what doesn’t and developing new standards and ways for physicians to implement them to the bedside or office.

The painful side effects of Obama’s healthcare reform – Los Angeles Times

The painful side effects of Obama’s healthcare reform – Los Angeles Times:

“Now, I’m well aware that having 47 million people who can’t afford medical care is a genuine social problem — although many of those millions are illegal immigrants, people between jobs and young folks who choose to go insurance-bare. I’m also aware that I can’t necessarily have everything I want, whether it’s a dozen pairs of Prada boots or a pacemaker at age 99. I know that Medicare is on the greased rails to a train wreck, and not just because of spiraling costs but because doctors are fleeing the system because they’re sick of below-cost reimbursements and crushing paperwork. There are ways to solve some of these problems: healthcare tax breaks, malpractice reform that would lower the cost of practicing medicine, efforts to make it easier to get cheap, high-deductible catastrophic coverage, steps to encourage fee-for-service arrangements of the kind that most people have with their dentists.

“In short, as someone who’s not getting any younger, I’d like to be the one who makes the ‘difficult decision’ as to whether I can afford — and thus really want — that hip replacement in my extreme old age. Sorry, President Obama, but I don’t want ‘society’– that is, government mucky-mucks — determining that I’ve got to go sit on an ice floe just because I’m old and kind of ugly, no matter how many fancy degrees in medicine or bioethics they might have.”

Nothing like folksy wisdom for understanding and dealing with the complexities of health care reform and modern bioethics. The usual right wing disinformation and misdirection are especially tiresome. So, to the rebuttal:

First pillar of fear mongering on health care reform: rationing. Be afraid, be very afraid. Ignore the rationing (by income and economic class) that’s already going on. Ignore rationing by private health insurers. Ignore spiraling costs that will soon have all but the top tiers of income earners on shoe-string insurance plans. Forget all that, just worry about the potential for rationing.

The point of Ms. Allen’s piece is that health care will be rationed by using arbitrary clinical parameters to deny care based solely upon costs. Or, she also warns, that some procedures will be denied based upon scientific, non-arbitrary clinical parameters, specifically along the lines of England’s National Institute for Health and Clinical Excellence which publishes guidelines and does medical and economic analyses of medical treatments to determine whether they are worth it to individuals and to society as a whole. I’m sure Ms. Allen finds it infuriating that some all other societies consider how utilization of finite resources affects everyone, not just the well off.

Interesting thing, that concept of “allocating scarce resources.” It is actually one of the centerpieces of medical professionalism developed by the American Board of Internal Medicine, the American College of Physicians and the European Federation of Internal Medicine and adopted by the American Medical Association and many other physician organizations. The Charter states, “The medical profession must promote justice in the health care system, including the fair distribution of health care resources. Physicians should work actively to eliminate discrimination in health care, whether based on race, gender, socioeconomic status, ethnicity, religion, or any other social category.”

This brings up fear mongering pillar two, always frame the debate as a choice between our current “system” or, the systems of either Canada or England, two countries that, while providing universal health care, because of their parsimony, have performed in international health care outcomes research almost as badly as does the United States! It seems genuinely ludicrous (but convenient for generating insecurity among the under-informed) to set as the benchmark for improving our health care system two countries who only do a bit better than we do. I have yet to see an opinion piece from a conservative decrying the inferior care and long wait times in France or Germany, the top performing countries in the world. That’s because they provide excellent care to all of their citizens, have no longer waiting times than our own, have much more satisfied physicians and patients and do it all at a sizeable discount to ours.

Another classic tactic is blaming the poor, the unhealthy, the “other.” On one hand, Ms. Allen laments the imposition of the 47 million uninsured onto our system, and forecasts that it will lead to unacceptable waiting times for those of us already “in.” A few paragraphs later she notes her understanding of the seriousness of the issue of the uninsured, but then posits that many of these 47 million don’t really need or deserve health care insurance as they are illegal immigrants or between jobs, etc. My brother was nearly bankrupted by being “between jobs” and having an illness in his family.

Back to our story. Ms. Allen makes a troubling conflation by muddling together limiting the amount we spend on health care in the last months of life with limiting health care to the elderly. There is a HUGE difference.

Ms. Allen cites the example of the hip fracture treatment President Obama’s grandmother received before her death and the pacemaker placed into the 99 year old mother of a town hall audience member as cautionary tales, indicating the “government run” healthcare would allow these patients to simply die because some intellectual, academic physicians in their ivory towers will give the thumbs down sign and demand their euthanasia. How sad that the public’s opinion of physicians and medical professionalism has deteriorated so badly that this is their expectation. Or, if not their expectation, but their cynical gambit that others will think this rings true.

Here’s the difference: Obama’s grandmother was terminally ill with cancer. The questions surrounding her surgery boiled down to whether it would improve her comfort in her last months and whether the surgery would ultimately shorten her life. As it turns out, it appears to have done both, making this a difficult case to slice down the middle as black and white. That’s why decisions like this cause ethical dilemmas: there are pros and cons to the decisions. There are sometimes non-operative decisions involving immobilization, aggressive pain management and other palliative measures that avoid the pain Mr. Obama was rightly concerned about. And sometimes these measures, especially in extremely frail elderly patients, are the right measures, because they avoid the very high mortality associated with surgery and other aggressive measures in this population.

The medical team, had they made the decision not to operate, would not have been bureaucrats determined to painfully end the life of an elderly cancer patient, but a compassionate team of professionals, balancing the patient’s quality of life in her last months (pain, hospitalization, removal from family and home, etc.), with her wishes and goals – perhaps to see her grandson elected President! When we strive to provide excellent end-of-life care, we balance all of these issues and we counsel our patients and their families as best we can because it is the right thing to do, not because it saves money. We would do it if it cost more: that is apparently the decision arrived at in this case. The calculation was made, as it should always be, based on the goals of the patient and family, not on a corporate balance sheet and potential executive bonus.

The second case, of the 99 year old requiring a pacemaker, is actually not much of an ethical problem. I agree with President Obama that these decisions should not be made based on “spirit,” but they certainly can be made based upon clinical guidelines and the individual patient’s health status. Regardless of this woman’s spirit, if she was a frail 99 year old with advanced chronic heart or lung disease, or with advanced dementia and a feeding tube for nourishment, one would be hard pressed to justify placing an expensive pacemaker or defibrillator into her, but a healthy 99 year old is another matter. It is important to note that Medicare did not deny either of these patients care, as a private insurer may have.

The other inappropriate conflation is the issue of limiting the amount we spend with limiting the amount we spend on treatments without proven benefits or with benefits so limited as to make them frivolous in most senses. If we presume that any guideline that determines a treatment not useful to be rationing, we will be in a world of economic hurt. This is actually the point of Comparative Effectiveness Research (CER), to try to figure out what we do that is costly but adds no value to patient care on one extreme, and figuring out what is relatively inexpensive and saves lives on the other.

Her assessment of the inherent inferiority of screening mammograms every three years compared to annually demonstrates precisely the need for CER: The automatic assumption that more testing means better outcomes. This is actually one of the bigger problems with American medicine, the automatic assumption that doing something, and not just something, but the newest latest most expensive something, is always best. Should the 99 year old patient get the latest greatest pacemaker? Maybe, but having some CER to help us make intelligent judgments should be lauded, not reflexively ridiculed by the anti-intelligentsia.

Update: a link to this item on my dailykos diary and a lively discussion.

QUALITY: Doctors Oppose Insurer Control Over Patient Care Decisions | New America Blogs

QUALITY: Doctors Oppose Insurer Control Over Patient Care Decisions New America Blogs:

“Some doctors have decided they are fed up and not going to take it any more.California pain specialist Dr. Bradley Carpentier is among them.

“While Republican strategists stir up fears about government meddling in health care, the San Francisco Chronicle reports on doctors like Carpentier who are concerned about insurance companies that come between them and their patients.”

Go read the rest.

The EMC Research Study is here.

Arch Intern Med — Abstract: Discussions With Physicians About Hospice Among Patients With Metastatic Lung Cancer, May 25, 2009, Huskamp et al. 169 (10): 954

Arch Intern Med — Abstract: Discussions With Physicians About Hospice Among Patients With Metastatic Lung Cancer, May 25, 2009, Huskamp et al. 169 (10): 954:

“Background Many terminally ill patients enroll in hospice only in the final days before death or not at all. Discussing hospice with a health care provider could increase awareness of hospice and possibly result in earlier use.

“Methods We used data on 1517 patients diagnosed as having stage IV lung cancer from a multiregional study. We estimated logistic regression models for the probability that a patient discussed hospice with a physician or other health care provider before an interview 4 to 7 months after diagnosis as reported by either the patient or surrogate or documented in the medical record.

“Results Half (53%) of the patients had discussed hospice with a provider. Patients who were black, Hispanic, non-English speaking, married or living with a partner, Medicaid beneficiaries, or had received chemotherapy were less likely to have discussed hospice. Only 53% of individuals who died within 2 months after the interview had discussed hospice, and rates were lower among those who lived longer. Patients who reported that they expected to live less than 2 years had much higher rates of discussion than those expecting to live longer. Patients reporting the most severe pain or dyspnea were no more likely to have discussed hospice than those reporting less severe or no symptoms. A third of patients who reported discussing do-not-resuscitate preferences with a physician had also discussed hospice.

“Conclusions Many patients diagnosed as having metastatic lung cancer had not discussed hospice with a provider within 4 to 7 months after diagnosis. Increased communication with physicians could address patients’ lack of awareness about hospice and misunderstandings about prognosis.”

First, having these conversations with patients is the right thing to do for a multitude of reasons, not the least of which is our duty to help our patients weigh the benefits and burdens of medical treatment. The reduction of unwarranted suffering is hard to over estimate.

Second, imagine the economic impact of doing the right thing. No rationing, just having the appropriate conversations with our terminally ill patients.

McKinsey: What Matters: Way too much for way too little

McKinsey: What Matters: Way too much for way too little

The title says it all. A great review of the American health care non-system.

Goes over administrative waste (83 cents of premium dollars go to actual health care at most in PHI market), outcomes, costs and prices, administrative burden, practice variation, and rationing (QALY’s CER).

Some good response letters as well.