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QUALITY: Is pre-chemo testing the future? by Harvey Frey MD

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Careful readers of this blog will have noted that along with reporting about the change in reimbursement for cancer drugs (and to get the real scoop on that you should see JD Klienke’s excellent article in Health Affairs), there’s also been a trend generally in favor of chemo-sensitivity testing before chemotherapy–largely considered a fringe activity by mainstream oncologists. Then this week the NEJM had an article generally in favor of pre-chemo testing. Did the appearance of this article mean that oncologists were moving the way of the pre-chemo testing radicals or did I as the dumb layman misunderstand it? I asked Dr Harvey Frey, who has written for laymen on this subject for THCB before but has generally not been in favor of it, what he thought.

I think you’ve got it right.

Now oncologists guess at prognosis and probable effective treatment based on how a cancer looks under the microscope, how extensive it is when found, and some blood tests. But even within the groups they’ve determined that way, there are still huge variations in actual patient response and survival rates. Since they never know who needs the treatments for sure, many patients are treated who might not need the treatment, and some get ineffective treatments before finding an effective one, and since the treatments are not innocuous, that’s bad.

They first tried doing sensitivity testing by growing cancer cells with different chemotherapeutic agents. For a variety of reasons, that never was very helpful. For years they have thought that, if only they could determine the actual genes responsible for cancer, they could break down the large heterogeneous groups into smaller groups with better defined responses, and spare many patients any treatment at all.

This study is a start toward that end, but still a small step. The technique doesn’t require that they try to grow the cells, but can be done on regular biopsies as obtained now. But so far all it’s shown is a correlation between their test and survival. They haven’t yet shown that they can predict response to hormones or chemotherapy. But there’s every reason to hope that they will ultimately be able to make such predictions, at least with better accuracy than we can now.

THCB UPDATE

Sadly, no posts from Matthew over the next few days. He’s on his way back to the UK for the holidays and having laptop problems, so his latest series of missives will be delayed.

BLOGS: Italics for anyone?

For some strange reason Blogger would not publish for hours today.  And then when it did, everything became italicized…..sorry! (Unless you like it that way!)

PHARMA: Fee-based distribution

Pharma wholesalers used to make their mark-up on tiny price changes. Like a Walmart, they’d buy now, sell later and pay their suppliers even later. As the suppliers were the hugely profitable pharma companies who made huge margins on each product, they weren’t too bothered about their downstream distributors making money by financial manipulation.  Add to the equation that prices were going up 10% a year, distributors were making even more just by holding inventory. But it was always a low margin business. The big three (Cardinal, McKesson, and AmerisourceBergen) have vast revenues but relatively tiny profits.  In 2003 Cardinal made $1.5 billion in profit, on $51bn in revenues. Not bad, but its biggest upstream supplier, Pfizer, made $11bn on $32bn in revenue.

Now distributors are having problems with their old model (in part because drug prices aren’t going up as fast). They are now trying to move to a fee-for-service model for distribution.  Here’s an interesting report as to whether that’s going to work. The answer seems to be, maybe.

HOSPITALS/POLICY: Matt Quinn on California staffing ratios contention

Last week our beloved Governor must have thought that he’s wondered into a John Leslie movie. 3,000 nurses protested his visit to a women’s conference (no less), and he told his audience that "I kick their butts" and that nurses–the most trusted people in the health care system–were "special interests". Oh and by the way this was at a conference in which CEOs who contributed to Schwarzeneger’s campaign were allowed to actively promote their own companies. While I resisted the temptation to use the headline Arnie takes on 3,000 Nurses,   Matt Quinn doesn’t want this to slip by THCB:

Don’t think that you’ve covered the Governator’s decision to repeal CA’s mandatory nurse staffing ratios. The reality is that most hospitals can’t (consistently) meet them . . .  which speaks to the acuity of the nursing crisis in this country (and especially CA).

While I certainly believe that most hospitals can do a much better job of allocating nursing resources (and some are using "bidding technology" to do so), there simply not enough nurses being produced . . . or staying in the profession.

Instead of encouraging hospitals to fight (and spend more money on bonuses, etc.) to recruit away nurses from other organizations in their areas by mandating ratios, it makes sense to increase the supply of nurses. There are lots of ways that the state and federal governments can make this happen . . . if it’s a priority. Arnold so far doesn’t seem to feel that this is a priority.

While Linda Aitken and others have done great research on correlating staffing with mortality, complications, etc., there remains too little effort in giving individual healthcare organizations the tools that they need to effectively (and empirically) balance staffing with quality, safety, satisfaction, and cost. "Standard" nurse to patient ratios represent too blunt a tool for this.

Ask any nurse (or hospital risk manager) and you’ll find that staffing is at least a contributing factor to the vast majority of medical errors / mistakes. Hurried people make mistakes . . . and can’t provide patients with the care and compassion that they deserve. Hurried and overworked people are also unhappy. While I applaud the (currently under funded by highly emphasized) efforts to implement IT as a solution to patient safety, having enough nurses (or clinical workers) should rank as high or higher…

There have been some pretty good articles about this in the Sacramento Bee of late.

QUALITY: Gordon Norman on DSM, Medicare and Oliver Stone & me

Last week there was remarkably little fuss in the health care press about the introduction of the new Medicare CCIP (DM-type) programs. I suggested that provider groups had been left out of the running when these programs were awarded. Gordon Norman, who runs DM at Pacificare and has contributed an excellent article on DSM to THCB in the recent past, and I agree that few provider organizations in the US would be able to run these big DSM demonstration projects, and that even fewer provider groups base their business on a preventative care and population-health coordination model (for the good of their own fiscal health). But I went further in suggesting that the ideological bias of this Administration and Congress was for private plans and organizations to solve the future issues facing Medicare, rather than the public program creating its own initiatives, or working with predominantly non-profit providers. No one would seriously disagree with that, but my connection of that fact with the non-appearance of providers or non-profits on the list of CCIP award winners has caused Gordon to disagree. He writes:

I have to call "Foul!" on your conspiracy theory…

It’s not evident from your blog entry today that you are aware of the latest DM Demo offered by CMS expressly targeted to providers and consortia where providers would take a lead role — the CMHCB Demo. (Here’s more detail on the CMHCB). Far from being the case that providers are "locked out" of the DM groundswell — if providers (remember, I am one of the guilty here) had manifested a sufficient collective will and effort to design a health care system that is primarily patient need-centric, then better integration of chronic care for patients, among providers, over time, across sites, among comorbidities, and embracing the biopsychosocial model might already exist and have obviated the need for a "DM industry" in the first place.

I can imagine my medical colleagues lamenting: "If only someone had accountability for that system’s performance (like oft-maligned executives in the managed care?), perhaps faster progress would be possible." As it stands now, it’s much easier for those who comprise our system to stand on the sidelines, as if helpless, and criticize others who are attempting to fill the care coordination vacuum of their own creation. At its best, DM is an "aftermarket fix" that can work surprisingly well under the right circumstances — that doesn’t mean it is superior to an "factory installed" integrated approach to better chronic care management by health care providers. "Systemness" is a fundamental property that is largely lacking in our health care system today, contributing to an inefficient, expensive, unfriendly, frustrating, and mediocre quality ecology for U.S. healthcare. When are providers going to become responsive to this obvious and growing need as an organized force? We’ll see how many line up for the CMHCB demos — I personally hope there are many and that they do well, since the DM need requires a very inclusive "DM tent" to address the gap between actual and ideal coordinated care. (And just wait for the Boomers…)

By the way, CMS made a commitment to those conducting the BIPA DM Demonstrations that it would not establish competing DM demos or pilots in their regions (e.g., CA, AZ, TX, parts of LA) which would jeopardize the results of this critically important DM study that will provider policy makers (CBO), advocates, and skeptics alike with rigorous RCT DM outcomes at least 1 if not 2 years in advance of the CCIP results. This was neither an arbitrary, capricious, or political decision, but rather a responsible approach to conducting a demonstration study without contamination that would confound the results.

Now I admit that my expertise on the finer points of CMS demonstration programs is limited, and I asked Gordon to confirm for me that the CMHCB awards are way smaller than CCIP and getting a much lower profile. Gordon stresses that CMS has reserved these for providers and that that’s the point!

Yes, the scale is different for CMHCB per award (though no specific limit on # of awards), somewhere between 800 – 3,000 depending on several factors — but that’s the point: it was designed specifically for providers. How many provider groups do you think could amass a patient population that would provide more than 3,000 Medicare FFS patients (HCC scores >2.0) willing to voluntarily participate in such a program with a 6 month recruitment window? Not many.

BIPA is 30,000 total enrolled maximum (+ another 12,000 controls which awardees also have to recruit, unlike CCIP or CMHCB design).

You and Mel Gibson and Oliver Stone should get together on the movie…

I told Gordon that if we were going down the Lethal Weapon path I’d rather make a movie with Danny Glover, and that anyway Michael Moore is already making this movie apparently. But slightly later I got a little more information from another of my DM sources, suggesting that there is trouble with the physician group practice demonstration. Apparently provider groups are dropping out from applying because OMB has changed the payment incentive formula. This is for one of the CMHCB demos that Gordon was talking about, and it looks like it’s in big trouble in advance of the award being announced. This is unconfirmed scuttlebutt and I personally don’t have the time to check it out, so please let me know if you can confirm or deny. But if true, it’s an interesting story, and adds a little fuel to the conspiracy theory fire about the Adminstration tilting the DM demonstrations towards the people it likes.

Paging Mr Stone…….

POLICY/ETHICS: Follow up to the Dutch euthanasia issue

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Well I’ve spent some time emailing with Sydney at Medpundit about her original article and she’s also received support from Enoch at Medmusings and Dr Bob at The Doctor Is In. All three are coming at this (I presume) from a Christian "faith-based" perspective and so there may be no possibility of them agreeing with a secular humanist like me. But let me detail my correspondence with Sydney and make one more attempt.

Last Friday after she had said that the Dutch doctors were the moral equivalent of those committing genocide in Bosnia, the Sudan and Nazi Germany, I called in this post for Sydney to retract her words. My argument was that this was a profound disagreement among well-meaning people, and that equating the Dutch with totally malevolent people was a) incorrect and b) insulting. I also argued that there was no specifically rational or moral difference between ending care and feeding of a terminally ill child causing its death, and actively causing the child’s death by, say, overdosing it with morphine. You could quite reasonably argue that this was kinder for the child as it reduced its suffering. And, as I showed using recent poll data, the former activity is accepted medical practice amongst pediatric specialists in this nation–just as highly regulated euthanasia appears to be becoming in the Netherlands. (As opposed to the unregulated, unstated euthanasia that’s been practiced by many physicians in many countries forever).

Note that I am not trying to convince Syd (or Enoch or Dr Bob for that matter) to change their views. What I am objecting to is anyone saying that  someone who disagrees with them (and acts accordingly) on this type of highly-charged issue is as evil as a human can be–there is no worse crime than genocide. Syd responded:

I disagree. You’re assuming some innate goodness on the part of the Dutch that would prevent them from killing others that they find too much of a burden, and/or some innate evil on the part of the Sudanese and Bosnian Serbs that allows them to kill normal adults they find burdensome. We are equally human and equally subject to moral failings. Once a society has decided it’s acceptable to kill those that are a burden, then any troublesome group is fair game. The only distinction between the Dutch, the Bosnians, and the Sudanese is who they define as a burden. And history has shown us more than enough that that definition belongs to whoever holds political power.

I responded to Syd by saying that "there is one absolute difference. The Dutch physicians believe rightly or wrongly that they are doing what they are doing purely because they are preventing the children from further suffering. They do not believe they are doing it for their own advantage–that’s your (mis)interpretation of their actions. The Sudanese/Serbs/Germans who commit genocide are doing it for their own perceived advantage and have no consideration of any kind for their victims.

There is also one relative difference. If you withdraw care and feeding from a terminally ill child with no prospect of recovery, it will die sooner than if you don’t. If you euthanize a terminally ill child the same is true. It’s a reasonable position to equate these positions morally, and if you do that then many, many physicians (as shown in the poll on my blog) are guilty of the same act. According to your logic, they’re all the same as those committing genocide.

If you cannot logically defend these points you should withdraw your remarks."

Sydney replied:

Active killing is active killing, regardless. The Dutch doctors may tell themselves they’re doing it to end the suffering of the children, but truthfully, there’s no indication that children with neural tube defects have pain just from the defects. They do have long, complicated roads ahead of them, however. The Dutch are making the decision for the children that those are roads best not taken. (According to press reports the physicians make the decision without even taking into consideration the parent’s wishes.) Take it from someone in the profession – doctors make those kinds of decisions most often based on how much of a hassle factor it will be for them, rather than the patient.

Here’s another example. In Germany, before the Holocaust, it became acceptable practice to euthanize mentally handicapped children. The doctors convinced themselves it was OK to do so because the children were too restless and unmanageable. They would put them down to put the "poor idiots" out of their misery. In truth, it was the doctors’ and nurses’ misery that was being eliminated. It wasn’t so much the patient’s condition that was the real problem, as it was the medical profession’s inability to manage their conditions properly.

It was not so long ago that people with even mild physical handicaps were treated as non-entities, even in this country. They were often locked away in their homes by their families. That’s still better than being euthanized out of pity, I suppose.

I guess that’s the difference between the two of us. I’m unconvinced that the Dutch doctors kill infants for completely altruistic motives. You are too willing to take them at their word.

I certainly won’t withdraw my remarks.

On a somewhat trite level it’s easy to refute Syd in this particular case. The Dutch hospital has set up a special protocol, consulted parents, judges and lawyers, and invited controversy including attacks like Syd’s from far and wide on the personal morals of those involved and their national character, all allegedly in her view to save themselves from the "hassle factor" of letting, so far, four children die by withdrawing care and feeding. I know in which course lies the "hassle" and it’s not in the withdrawing of care and feeding. Furthermore, Syd has convinced herself that because she’s seen doctors take those type of decisions for reasons of their own comfort–you see it happens here too–that the Dutch doctors must be doing it for that reason. She also hasn’t bothered to try to logically untangle the relative difference between causing death by action and causing death by deliberate inaction. She just says "active killing is active killing". Similarly Enoch says:

I think there’s a huge difference between allowing a person to die off of life support, and actively ending the life of the person. It’s true that it’s an action to take a person off of support, but that’s morally acceptable to me, to remove life support from a terminal incurable process that will inexorably lead to death soon. Removal of life support is completely different from an action promoting and accelerating death and altering the natural course of disease.

None of them come up with a "why" as to there is a difference. In their view it just is (based presumably on their interpretation of their theology), and that’s that.

Sorry guys, but that’s not good enough. You are all supposed to be scientists and scientists are supposed to bring reason and logic to bear on problems. You may well be right, but you have to at least attempt to prove your case.

But it’s accusing the Dutch physicians of moral equivalence of genocide that is not acceptable. Let me give an analogy. A while back there was a huge brouhaha when two of some 1200 amateur made videos commercials submitted in a contest to Moveon compared Bush to Hitler. As soon as Moveon realized this, they took them out of the contest, and they were rebuked (rightfully so in my view) by both the Republicans and the Democrats for not weeding the commercials out earlier (even if hardly anyone saw them). Now, if you really wanted to, you could draw a parallel between Bush and, say, Stalin. Bush has ordered the indeterminate detention without trial of at least two American citizens. Is he as bad as Stalin, who had thousands detained without trial and tortured and killed? The ACLU (of which I’m a member) has vigorously opposed these detentions (and those of several hundred more non-citizens) as being opposed to fundamental human principles of due process (not to mention the Bill of Rights). However, no reasonable person would suggest that what Bush is doing equates him with Stalin, even though indeterminate detention without trial was a hallmark of Stalin-ist totalitarianism. Whether you agree with him or not, Bush (and his administration) seriously and sincerely believe that the relatively limited numbers of detentions carried out are essential to protect the United States and its citizens. No serious historian believed that Stalin’s use of those tactics (and much worse) was anything other than a means of crushing any possible opposition.

By equating the Dutch physicians with the genocide seen in Rwanda, Sudan, Bosnia and Nazi Germany, Syd and the others are doing the equivalent of saying that Bush is the same as Stalin. That’s what’s so offensive.

BLOGS: Other stuff that’s worth a look

Between the back and forth with Medpundit and the DSM stuff I’ve had to be all too brief on some other great stuff. But it’s worth taking a look at

    • Dr. Ron Grelsamer’s new Knee Hip Pain Blog, which has a wryly amusing look at how surgeons (try to) deal with insurers
    • The new libertarian HC Blog, isemmelweis written by Trapper, a young but sadly all too experienced patient. Like the rest of the health care libertarians it’s nuts highly theoretical and impractical, but it is interestingly so.
    • Don Berwick likes what he sees about the UK’s NHS and its attempt to improve quality.

Note to self–I have too much in the hopper at the moment, but hopefully will get back to these issues soon. Also have to deal with the new cancer treatment scenarios, the recent study on EMRs and finally, finally, must finish my piece on King/Drew.

POLICY: Medpundit totally misreads the euthanasia debate in Europe, and is incredibly insulting to boot.

I tread gently around criticizing Sydney at Medpundit because her blog is so good even if her politics are increasingly "out of the mainstream" and the evidence she uses to support them is often incomplete, nay baffling. (See this piece reviewed by Ross on how Kerry planned to put everyone into Medicaid, although her argument rested on the ridiculous assumption that all employers would simply stop offering health benefits if Medicaid eligibility were expanded–even though there’s nothing stopping them from dropping benefits now, theoretically).

But in her Tech Central Station piece on the euthanasia issue in the Netherlands she has crossed the line and needs to be repudiated. The issue is that some Dutch doctors have decided after consultation with parents and the judiciary to euthanize terminally-ill babies rather than withdraw care and feeding and have them starve to death. It seems to be done with the utmost care and sensitivity:

"It is for very sad cases," said a hospital spokesman, who declined to be identified. "After years of discussions, we made our own protocol to cover the small number of infants born with such severe disabilities that doctors can see they have extreme pain and no hope for life. Our estimate is that it will not be used but 10 to 15 times a year."A parent’s role is limited under the protocol. While experts and critics familiar with the policy said a parent’s wishes to let a child live or die naturally most likely would be considered, they note that the decision must be professional, so rests with doctors. The protocol was written by hospital doctors and officials, with help from Dutch prosecutors. It’s being studied by lawmakers as potential law. Under the protocol, assisted infant deaths are investigated, but so far all of them have been determined to have been in the patients’ best interests.

Both the Dutch and philosopher Peter Singer feel that their actions are morally similar to abortion when a foetus has no hope for life. No doubt Syd disagrees with this, and probably (although I don’t know) with the legality of abortion too. Many who share her views on that also disagree with contraception, and even male masturbation as depriving the possibility of life (for a lot more on the social repression of masturbation up to the firing of Jocelyn Elders for mentioning it see here, but be warned there are some graphic pictures).

Disagreement over these issues is bound to happen and be controversial. However, Sydney goes on in her article to equate the behavior of the Dutch doctors, judges and parents as being the moral equivalent of the people who have committed genocide in Germany, the former Yugoslavia and the Sudan. That is a reprehensible thing to say. And there is a shiningly clear difference. The people in the Netherlands are clearly trying to do what they believe to the best thing for the children concerned. Syd may not agree that what they did was in the best interests of the children, but that is what the Dutch believe. I don’t know if Syd approves of the conventional treatment here of withdrawing food and care and allowing terminally ill kids to starve to death, but to me morally they amount to the same thing. Coincidentally, this week’s Pediatrics journal has an article on Do Not Resucitate orders for children undergoing surgery, which included a survey of pediatric surgeons and anesthesiologists. It finds that:

The majority of anesthesiologists (86%) and surgeons (94.7%) were willing to withdraw life support at the request of the family a few days after surgery if a child suffered an arrest in the operating room, was resuscitated, and had an adverse change in quality of life. The majority of anesthesiologists (55.1%) felt that the perioperative period ended when the child left the recovery room, with only 38.2% of surgeons agreeing (P = .0037). Many anesthesiologists (22.4%) and surgeons (39.5%) felt that the perioperative period should be extended until 24 hours after surgery.

Given that withdrawing life support means that the terminally ill child will die, there’s logically little difference between this and the direct euthanizing that’s happening in a few cases in the Netherlands. I’d argue that there’s no real "slope" whether slippery or not between these actions but there is a vast series of huge steps down to genocide. And logically if that’s the case then Sydney’s accusing the vast majority of physicians in this survey of being on the same moral stature as those involved in genocide.

That type of accusation has no place in our relatively civilized corner of the blogosphere, and if Syd won’t make that clear, the rest of us have a responsibility to call her out on it.

PHARMA: Overdosed America’s Abramson on CSPAN

John Abramson MD has an excellent book out called Overdosed America in which he criticizes pharma, the FDA and the medical journals for, at the least, bending the truth. To get a flavor of it, read the piece he wrote for TCHB last month. To get a bigger flavor of it those of you with no lives can watch his talk on C-SPAN on Sunday at 5pm–presumably the rest of you have Tivo!

Meanwhile, the final part on the Drew/King story has been bumped till Monday. Sorry to those of you waiting for it!

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