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QUALITY: DSM– Convincing anyone? Maybe. Improving health? Probably. Saving money? Probably not. (with clarifying UPDATE)

The Wall Street Journal (from which this is stolen in its entirety as most of you can’t get to it) basically advocates Pfizer’s claim that their DSM process in Florida works and saves money; $41.9 Million to be exact:

Pfizer Inc.’s health-management program in Florida cut the state’s medical costs by $41.9 million in the 27 months ended in September 2003, Pfizer said Tuesday. Pfizer, the world’s largest drug maker, in 2001 launched the joint initiative, which provides patient education and nursing care to patients with chronic diseases such as diabetes who are covered by Medicaid, the federal and state health-insurance program for the poor.The goal was for Pfizer to save Florida $37.5 million for the life of the program’s four-year contract, which ends in September next year, Pfizer spokesman Jack Cox said.

During the 27-month period, Pfizer also has given the state about $19.2 million worth of other investments and its medicines, Pfizer said. The results of the program so far validate "the original approach we took with respect to the state’s budget problems," Henry McKinnell, chairman and chief executive at Pfizer, said in an interview with The Wall Street Journal.

He said Pfizer is in discussions with other states about applying the same approach. But Florida has been alone so far in pursuing the Pfizer model. The results were determined by Medical Scientists Inc., an independent organization.Mr. McKinnell praised Gov. Jeb Bush’s willingness to try the approach despite opposition in some quarters in Florida. Meanwhile, Pfizer is talking with several employer groups about applying similar principles and is looking for partners overseas for analogous projects in Germany, Italy and Sweden.Under the current contract, Pfizer is exempt from paying heavier rebates on drugs for Medicaid patients in Florida, in exchange for offering its disease-management services.

However, earlier this year, the Florida Legislature put a stop to new contracts like this that offer value-added programs in lieu of supplemental rebates. Pfizer’s program remains in force through September 2005, and the company said it would use the positive results in an effort to persuade lawmakers to reconsider allowing such plans beyond then. Pfizer said that the program has reached nearly 150,000 Medicaid beneficiaries in Florida.

But the State of Florida is by no means as happy as Pfizer thinks it should be, or as the WSJ’s cheerleading suggests it is. Why not?

The disconnect between Medicaid, Florida lawmakers, and Pfizer hinges on a scathing report put out by the Office of Program Policy Analysis and Government accountability several months ago. In a roundhouse blow to Medicaid DM in general, the OPPAGA said that the Legislature’s big hopes for disease management never panned out; big savings weren’t being realized, the numbers that were reported were suspect at best, agency oversight was weak, and many of the recipients that were supposed to be in the program weren’t. In fact, only about a quarter of the chronically ill patients ever made it into DM. Their penetration of disease categories were only 19% for Asthma, 29% for Diabetes, 17% for CHF and 22% for Hypertension. (though they were at 69% for HIV)

Based on OPPAGA methodology, DM did pay back $1.46 in savings for every $1 spent. LifeMasters, for example, was credited with saving slightly more than $5 million for its CHF program, comparing the $7.63 million in program costs with $12.66 million in gross savings. Pfizer produced $900,000 in net savings in a program that cost $7.5 million. And in a field where there are no "perfect methodologies," OPPAGA said that Pfizer’s calculations for determining gross savings were fundamentally flawed, seriously inflating its earliest returns. Just don’t tell that to Pfizer, which fires back that OPPAGA is the one that’s guilty of fuzzy math."The report is not accurate," counters Cox. "It had several glaring errors in it. They didn’t even recognize that Pfizer was paying for the program."

But perhaps even more convincing for state legislators, OPPAGA had already rendered a negative verdict on the kind of value-added program that Pfizer championed. Not only were drug companies avoiding discounts or supplemental cash rebates if they offered value-added programs, the state agency maintained, so were their competitors. Any drug company with a competing product didn’t have to discount its price significantly to get a drug on the preferred drug list if Pfizer and the others weren’t discounting at all.

In fact the state believes that it gave up closer to $60m in rebates and discounts to get those $40m in savings. In other words, DSM works but not well enough. That has a nasty implication for drug companies trying to use DSM as a wedge into preferred positions on formularies. Payers may believe that they are better off just getting the maximum discount possible from the pharma company (which its competitors then have to match) and paying for the DSM themselves, rather than giving the pharma company a better deal and hoping that they’ll save more in payback from a the DSM process that the pharma funds. This should be pretty good news on the face of it for the independent DSM vendors like Lifemasters and American Healthways, but then again there are three sides to every story.

The third side has been causing a fuss in the DSM community this week. A couple of different studies have not such good news for the whole DSM community. One from Texas is about CHF patients using ACE inhibitors, and another is about the results of Kaiser Permanente’s DSM programs since 1996.

The

first study from Univ. Texas researchers showed that a DSM program for a chronically ill populations with CHF and diabetes didn’t save any money. Smartmoney reports that:

After 18 months, the disease management group lived an average of 76 days longer than those in the control group. But the study showed no difference in doctor visits, hospitalizations and prescription drug costs.

"Unfortunately, it did not save any money at all," said Dr. Autumn Dawn Galbreath, the study’s lead author. She noted that some states such as Florida have set up disease management programs and then cut their Medicaid programs in anticipation of savings. She said previous studies of disease management programs were smaller. She also said they preceded newer treatment guidelines, which appear to be more effective in managing heart disease. For example, heart patients are now routinely put on blood-pressure lowering medications known as ACE inhibitors. Fewer than half of patients in previous disease management studies were on ACE inhibitors, while 77% of patients in the Texas study were on them, researchers said.

Meanwhile the Kaiser study in Health Affairs (abstract here, full paper here) comes straight out and says that costs for the group in the DSM programs increased, as did quality indicators. Some extracts from the Kaiser study:

Costs rose for each of the four conditions during the study period. After adjustment for age, sex, and inflation, annual costs for CAD patients, for example, rose $2,110, or 19 percent. Among adults without the conditions, costs increased by fewer real dollars yet by greater or equal percentages. For patients with and without the four conditions, costs rose in each of the five categories (data not shown). The only exception was hospital costs among diabetes patients, which stayed the same. Increases were steepest for pharmacy costs and least for hospital costs.

Hospital admissions increased less on a percentage basis in the chronic disease populations than in their comparison populations, and, with the exception of heart failure, so did hospital days. Diabetes and asthma patients had fewer hospitalizations in 2002 than in 1996, even as hospital days stayed about the same. Heart failure and CAD patients had more hospital days in 2002 than in 1996…..ER visits decreased by a greater percentage for asthma patients than for their comparison group.

A commentary from some senior staff at Permanente suggested that even though costs went up for the DSM group, there were savings over what the costs for the groups in the absence of the DSM program would have been. Of course there wasn’t a control group for Kaiser like there was in the Texas case. However, most quality measures or process measure outcomes such as levels of LDL, etc, were overwhelmingly positive. And the commentary also pointed out that Kaiser patients were relatively well managed (and had relatively little money spent on them) in advance of the program’s creation. So it appears that finding cost savings is very hard–especially if you’re not screwing up in the first place–while improving care quality is somewhat easier.

Of course, the members of the online DM Forum had various opinions, ranging from Al Lewis saying that

you could surf in Tahiti even if the "old school" said you couldn’t (i.e. he didn’t believe the Texas study) to those (Vince Kuratis) who said that the problem was either the patients were already too well managed — already 77% of them were on their ACE inhibitors — or (Mary Wieg) that they weren’t sick enough on average and that DSM should concentrate on the sickest ones. Still others (Margaret Radzwill) suggested that the actual DM process itself was flawed because there were fewer patients on ACE inhibitors at the end of the study than the start. And occasional TCHB contributor Dave Moskowitz put out a press release saying that the ACE inhibitors being used were the wrong ones in the wrong dose! (There’s alot more comments at the Forum and if you’re interested in this topic you should sign up).

There’s a lot to chew on here, but the obvious conclusion is that while DSM is good for patients, it’s hard to get some patients into it and once you get past the really low hanging fruit, it may not be that good for the bank balances of the sponsoring plan/payer. That plans have been reluctant to do DSM is no new news. Don’t forget that most Americans will move from their health plan in less than two years. So the incentive to put these programs out there remains cloudy for most private plans because even if they do pay back, the money will be saved by the next plan, not them. So we shouldn’t be surprised that DSM is not storming the world.

But it’s a bit of a shock to find that DSM might potentially hurt the bottom line of a plan like Kaiser that tends to keep its patients around. (Although the Kaiser top brass apparently don’t think that it is hurting them, other health plan execs might not be so sanguine). As Medicare is starting to lumber towards DSM this is going to be a big discussion issue, and it would be very nice to know what’s really going on.

UPDATE: Mary Weig, who I referenced as saying that the patients in the Texas study weren’t

sick enough on average and that DSM should concentrate on the sickest ones, writes in accusing me of being a Fox News employee:

The way you quoted me was a bit misleading. My point was that DM programs should concentrate on people who are not complying with optimum treatment plans–as well as the sickest ones. If they don’t comply with optimum treatment plans, they will end up sicker eventually. That’s why stratification and focus are so important.

This piece has generated quite a bit of feedback (some of it quite complimentary), and at least one excellent detailed response. So please check back for more on DSM tommorow. (And no, of course Mary never said I should work for Fox, but if they’re hiring….)

POLICY/HEALTH PLANS/HOSPITALS/PHARMA: Wall Street roundtable on the industry

(Note: somehow this was written and not published 10 weeks ago in early September…showing both that I’m fallible and that not that much has changed in 10 weeks, apart from a little minor politicking. Given that Friday is the lighest traffic day on TCHB, I figure I can get way with posting it now!)

HSC is out with its newest issue brief and this one is a summary discussion of several Wall Street analyst types about the health care industry. It’s a very intesting piece. Here are a few key nuggets (or the “shorter” version in blog terms):

  1. Health plans are pricing high to avoid a repeat of letting trend get away from them as happned in 1997-9. Employers apparently are back to being cranky, confused, aimless and spineless, but are pushing costs onto consumers. Trend is slowing which will eventually put downward pressure on premiums.
  2. Medicare regional PPOs are a non-starter, but there’ll be money made in Medicare HMOs on a county by county basis until Congress wises up and cuts back on HMO payments (i.e. we’ll revisit the 1992-1997 cycle)
  3. CDHPs are massively overhyped.
  4. Hospital spending isn’t going up as fast as predicted just a couple of years ago and the rapid pace of physicial plan expansion could lead to overcapcity and bad news for hospital pricing

There’s also a transcript of the whole discussion. I don’t agree with everything they say (and Wall Street analysts are often as wrong as Internet health pundits albeit at a much higher salary) but it’s well worth reading as a view on what several smart people who watch the numbers of the industry very closely see coming down the pike.

QUALITY/POLICY: Paying people to stay thin? by Anonymous

Earlier this week THCB discussed the obesity problem in relation to personal health ecologies. It as pretty sobering stuff, but one anonymous correspondent has an out-of-left field suggestion:

Your mention of pay-for-performance in relation to obesity management just gave me an idea that’s probably silly, but I’m going to toss it to you anyway. My assumptions are that obesity costs all of society money, that businesses have a vested interest in access to a healthy flexible labor pool, and that a major cause of obesity is the stress caused by our change-oriented, scarcity-driven quasi-capitalist system.

What if society offered guaranteed minimum financial support to people who stayed within target personally-controllable health criteria and remained on-call for work? This is not to say support should be withheld from people who can’t stay within the target range or who for other reasons might fall outside that system: I’d just suggest the form of support be different. For example, disabled people get disability support, people who are unemployable for various reasons (language problems, obsolete skills, etc.) get eligibility help, and people who are simply non-conformists (including the person who objects to health regimens) should still be considered part of society, as well. I’m not sure what sort of provision should be made for the last case, but I bet paying people off to remain productive potential for the workforce would be cheaper than where we’re going now.

Unfortunately, even if this actually makes financial sense, people would probably reject this approach for ideological reasons. I have several disabled friends, and they’ve all pointed out the numerous ways society could save money, but would rather pay triple than give direct payments to the disabled. The same has been said about the cost of the prison system. As far as I can see, this means people will pay anything to prevent direct payments to people outside their immediate tribe, however that’s defined. However, maybe if it’s conceptualized as paying for a reserve, flexible workforce to make the country more competitive, people might reconsider.

If you think about it, right now obesity is the ultimate revenge against untenable social processes. Self-destruction reduces the extent to which cruel and amoral forces can use you.

PHARMA: Vioxx not an anomally, by John Abramson MD

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Will Celebrex and the other Cox-2s follow the Vioxx path? Indications from Canada based on 14 reported deaths suggest that they might. Meanwhile Pfizer is initiating an ambitious and potentially risky clinical trial to try to prove that Celebrex is good for your heart (or at least not as bad for it as Vioxx!) Given that the risks of Vioxx were known for several years by Merck and some others, is the FDA paying enough attention to the safety of the nation’s drugs? I don’t know and I’m sympathetic to the argument Sydney made in Medpundit a while back about the good of the many taking Vioxx versus the incremental risk for the few. However, John Abramson, the author of Overdosed America: The Broken Promise of American Medicine is pretty sure. He writes this for THCB:

Research on Vioxx done for my book, Overdosed America, was included in Monday’s Wall Street Journal article. The lack of public discussion about the two most important lessons to be learned from the Vioxx recall guarantees that this debacle will be repeated again, and again, and again.

The VIGOR study that Merck completed in March 2000, comparing the safety and efficacy of Vioxx to naproxen (Aleve), showed clearly that even among those without a previous history of cardiovascular problems, Vioxx doubled the risk of heart attacks, strokes, and blood clots. Vioxx actually increased the number of serious cardiovascular problems more than it decreased the number of serious gastrointestinal problems. The FDA’s cardiology reviewer wrote in February of 2001 that the increased risk of cardiovascular complications with Vioxx "could lead one to conclude that naproxen…would be the preferred drug."

And the most important finding of the study: The people who took Vioxx developed 21% more serious complications (the kind that cause hospitalization or death).

The problem is that neither of these two findings was included in the November 2000 issue of the New England Journal of Medicine. So doctors were left believing that, even though Vioxx is no more effective at relieving arthritis symptoms and cost many times more than naproxen, Vioxx was the better drug for their patients.

The more general issue (and the primary theme of my book) is that most of even the best information available to doctors and patients is produced and disseminated by commercial interests with the goal of improving their bottom lines, not the health of the American people. Seventy to 80 percent of our clinical studies are now funded by the drug and medical device companies. Among the highest quality research, the odds are still 5 times greater that commercially sponsored studies will favor the sponsor’s drug than will non-commercially funded studies.

If the health care market is to serve the interests of society, the quality of the information that provides the basis for health care decisions must be impartially overseen. The situation that we now have with drug companies funding and controlling most of our clinical research is like a professional football team generously providing the referees for its games.

Many people say that the last thing we need is another federal regulatory body. But not even libertarians suggest that the government should back out of its role in the enforcement of business contracts. In our "information age," accurate medical knowledge is as fundamental to the quality (and cost) of our health care as is the enforcement of contracts to the function of markets.

The fundamental "lesion" in American health care is the normalcy of commercial bias in our medical knowledge–which now grows toward corporate profits the way that plants grow toward sunlight. Until this problem is addressed unsafe and unnecessarily expensive drug like Vioxx will continue to achieve "blockbuster" status, and Americans will continue to pay more than twice as much for health care yet have the worst health of 22 industrialized nations.

QUALITY: NEJM sneaks in early about “To Err is Human” plus 5

The NEJM has an article about the IOM patient safety report five years on. It’s by by a pretty elite group; Drew Altman of Kaiser Family Foundation, Carolyn Clancy, head of AHQR, and Bob Blendon at Harvard. Basically they are over kind to the system, suggesting that a move from 4% to 7% of hospitals putting in CPOE is a big deal, when it’s not really. I hope to have Michael Millenson, who is not so kind to the system commenting on this in the near future in TCHB. Anyway, the authors also note that the public perception of health care providers’ safety has been considerably reduced:

Unfortunately, despite five years of focused attention, people do not seem to feel safer. More than half (55 percent) of the respondents in our survey said that they are currently dissatisfied with the quality of health care in this country — as compared with 44 percent four years ago.5 In fact, 40 percent believe that the quality of health care has “gotten worse” in the past five years, whereas only 17 percent think it is better. And half are worried about the safety of their medical care.

Altman, Clancy and Blendon think that we’ll likely solve the patient safety issue as there’s bi-partisan agreement on the need to solve it and the info-tech needed to solve it is becoming more widely used. But they also stumble upon the key issue which is that:

Physicians also strongly oppose public reporting of information on medical errors — perhaps because of worries about malpractice lawsuits, which physicians name as the top concern facing health care and medicine today. In stark contrast, 71 percent of the public believes that public reporting of medical errors by government agencies would be very effective in reducing errors, and 7 in 10 persons say that such reports would tell them “a lot” about the quality of a hospital or a health plan.

Well they’re a lot more optimistic than I am. In over a century of conflicts between what’s good for doctors and what’s good for the public, only one side has ever won. Some leadership from the AMA on this issue would be nice, but I guess they’re busy pissing off the trial lawyers. And the importance placed on that conflict is most of the problem, and it’s one that I fear that the reasonable authors of this article understate.

QUALITY: Personal health ecologies as the future of DSM.

I spent a day last week at IFTF’s meeting on Personal Health Ecologies. These are my notes, so use these as provocation material rather than a finished argument. But something important is slowly going on here, and health care wonks and industry players should be aware.

As you know I have some affection and connection for IFTF. Their research lately has veered away from the health care system per se and is looking more at health as a lens for commerce–that is looking at the potential businesses to support consumers living their lives with a health focus. They call these personal health ecologies–more about them on page 10 of this report. The crowd at the meeting was not just the traditional health plans/pharma/services types but also financial services companies, software companies, hardware, consumer goods vendors and anyone else looking to learn more about consumers.

One major part of the research this year is looking at the behaviors of the chronically ill. Businesses are getting interested in figuring out these groups as there will be more and more of them in the future. Today’s meeting looks at the chronically ill, and how they manage their own health ecology. This doesn’t just mean their interactions with the “health care system” (plans, doctors, hospitals) but also with their relationships (family and friends), their connection with products, with technology and where they care for their health. To do this IFTF did a whole bunch of ethnographic research, following people around at home, at work and in their daily lives just managing their disease. This is all pretty intangible stuff for a business, but it’s basic research that is important for developing products and services.

So what are they looking at? Diabetes, obesity….

Rod had a “fun” scenario looking at obesity. Interestingly as Generation Y gets fatter, their rate of health spending will increase much faster (maybe in their 30s as opposed to in their late 40s). What might be evidence of this scenario? The key question is at what point will obesity and physical inactivity overtake smoking as the leading cause of preventable death. As obesity and diabetes increases there’s much more focus on obesity and prevention amongst men and children, rather than just Weight watchers as a place for women concerned about looking good.

In terms of business opportunities, there’s a lot of invisible work in tracking and managing disease–so there’s a huge opportunity for routinizing their information management and automatic data capture at home–same as in the hospital (80% of nurses work is recording data and that’s slowly being captured and recorded automatically). Also having to interpret the results of the data, which are not intuitive to the patients.

There’s a real problem for chronically ill people. They get on and off their regimens because they can’t stay there. We need something to make the treatment less miserable than the disease.

So what were the companies at the conference doing to help the chronically ill? Three examples at the meeting:

  • Intel is trying to wire the home. They realize that health doesn’t live on the desktop, so how does Intel get into it? They have test houses out with RFID sensors everywhere and devices networked together, and even biometric devices that can be in the bloodstream. They’re also trying to develop mote-based sensors.
  • Abbott, in its diabetes division has a wireless sensor implanted into the skin sending continuous a wireless data stream to a glucose meter on the belt, called the Freestyle Navigator.
  • Health Hero has a new version of the Health Buddy out which is now both text and voice operated, and can be connected to devices like digital scales.

In many ways the potential success of this is linked to pay-for-performance or more likely some form of pay for outcomes. This is (maybe) going to drive the adoption of disease management techniques in Medcare populations, and may move some of the techniques Health Hero and others are using into the mainstream of health care delivery. We’ll see, but it’s a long transition from where we are now.

Meanwhile, the conference moved onto a riveting session about wider issues of how to change the wider patterns that cause obesity and diabetes, and made me feel very fat! What might stop this trend? Stanford Prof Christopher Gardner tells us that its the Mediterranean plant-based diet rather than the typical American diet….but how to make people change? (Here’s more on his techniques). At the moment we focus on people changing but in fact you can change the way people eat by packaging–but that’s been used so far to make people eat more. Chris recommends “Food Politics” and “Fast Food Nation” as great books that have far more impact than any moralizing professor suggesting a diet. But Susan Foerster from the California “5 a day” campaign (State of California Health dept) shows that financially there is no way to marketing-wise fight the fast-food monolith. Something like $50bn is spent on food advertising (none on veggies) versus under $400m of PSAs. The result = obesity. (Did you know there were 66 spoonfuls of sugar in a 7-11 Super Big Gulp?) And this runs to other political decisions — $72 per capita spent on roads compared to 0.55c spent on pedestrian walkways. Also limited access to fresh produce in poorer areas.

This is all depressing stuff. My view is that the cost of obesity is massive but the marketing is all pushing this one way–to more obesity and more chronic disease. The only way to break this is to divide the corporations who are paying for the costs of obesity from the food companies who are making money from it. But that’s a long way away from our current medical culture. So my bet is on more obesity and more diabetes. Interesting stuff.

POLITICS: A reply to my wanted ad

Dear Sir

Please consider me for the position outlined in your ad of 11/4/04. I believe I am eminently qualified for the position outlined in the job description. I have over 30 years experience the elimination of human rights, promote torture, plunge their children into monstrous debt, and aid in the elimination of civil liberties at home and international law abroad. Coincidently, I am of faith based on an obscure interpretation of vague texts written 1900 years ago, selected several centuries later by a brutal dictator who wanted his subjects to worship him as God; although my adherence is only when convenient. I am strongly opposed to the principles of the Enlightenment and rational thought.

I hope you will consider me for the position, as I am currently between careers. I would need an advance for moving expenses as my assets have been frozen. This link is to my CV.

(Ed’s note: While unlike Republican Joe Crea who forwarded me this application I didn’t know that this guy was a Bush fan, I knew that his “friend” was).

OK. That’s the last word on the non-HC parts of the election, apart from the minor celebration that we in the reality-based world must have at the fact that theocratic fascist AG John Ashcroft has quit. Even Bush will struggle to replace him with someone worse, assuming David Duke doesn’t want the job.

HEALTH PLANS: Looks like Anthem/Wellpoint has ground Garamendi down, with UPDATE

In the new political climate post election, it looks like John Garamendi (California Insurance Commisioner) has taken the latest bribe Wellpoint has put on the table and given his go ahead to its merger with Anthem. There’ll be a press conference later today to confirm the details, but Wellpoint stock is up heavily on the news. Wall Street hasn’t really noticed that a few other states including Georgia have since withdrawn their approval of the merger, but presumably those state officials can be similarly mollified.

It does make you wonder if the bigger California agency that approved the merger earlier, the Dept of Managed Health Care, got all it could for the state’s consumers and taxpayers.

UPDATE: So the final bribe total (excruciating details here) is just another $150m. Reuters says:

Insurance Commissioner John Garamendi said in a statement he had agreed to drop objections to the deal after Anthem said it would pay $35 million to fund California clinics, $15 million for nurse training and to raise its investment in the state’s “Healthy California” program to $200 million from $100 million.

At least the other insurance commissioners across the nation now know that they can hold out for double the money. But this is all small beer. Wellpoint’s market cap today rose 9% or over $1.5 billion. Presumably Garamendi thought he was going to lose in court. Here’s his version of reality.

PHARMA/QUALITY: More in chemo sensitivity testing, by Larry Weisenthal

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As I mentioned the other day, I have another article on oncology in the queue which got pressed for space as the election heated up. Larry Weisenthal, MD, is a board certified medical oncologist with a 25 year history of full time work in the field of cell culture drug resistance testing (otherwise known as “chemosensitivity testing”). More about Larry may be found by looking at his CV. He writes:

The issues and data relating to chemosensitivity testing defy concise summary and can be reviewed on my website. For the moment, I just want to make a brief response to the comments of Harvey Fry (on THCB a couple of months back). Harvey had written about chemosensitivity testing:

I fought for chemo-sensitivity testing of cancers over 20 years ago, and finally lost because of the problems with the tests. First, it’s often hard to get a representative sample of tumor cells by biopsy. Then it’s hard to get them to grow. Then you’re not sure whether the cells that grew out are the tumor cells, or normal matrix, like fibroblasts. Then there’s the delay in starting treatment while waiting for the cells to grow out. Then there’s the question of whether cells in metastases have the same response as those in the primary. But the killer was that the clinical response was not that well predicted by the cell survival tests in the lab. And of course, there was the expense.

Unless there has been some major advance in the intervening years, I can understand the reluctance of some oncologists to go back to it. Alternatives to growing the cells and seeing what kills them may now exist, but they are only surrogates for the real end-point of interest.

Firstly, Dr Fry obviously has no understanding whatsoever of the current technologies, which are based on cell death and not cell growth. To put things into historical perspective, interest in “culture and sensitivity testing” for cancer received a tremendous boost with the publication of a preliminary paper describing a cell growth assay in the New England Journal of Medicine in 1978. When the NEJM talks, people listen. Within a year, hundreds of laboratories were working with this particular cell growth assay, and it did, indeed, pose the problems cited above by Dr. Fry. These problems were exposed in a devastating, negative editorial, published in the NEJM in 1983. The NEJM giveth; the NEJM taketh away. All the laboratories shut down; research in the field virtually ceased, and the take home message in the minds of most clinicians was that the assays had been discredited. Dr. Fry’s comments reflect this thinking.

In 1983, other publications introduced assays based not on cell growth, but on cell death. This was a good 5 years before dissemination of understanding of the concept of apoptosis (a genetically programmed cell death pathway which exists in all cells, which is supposed to cause them to commit suicide if they become functionally deranged, but which doesn’t function properly in cancer cells, allowing them to grow abnormally without committing suicide, but which can be triggered to occur by effective anti-cancer drugs). Because clinical oncologists did not understand about apoptosis, these pioneering publications with cell death (instead of cell growth) endpoints were ignored, and neither clinical trials nor the application of cell death drug resistance assays were supported by academic and private practice clinical oncologists.

Despite the theoretical concerns expressed by Dr. Fry, the clinical utility and clinical accuracy of cell culture drug resistance testing with cell death endpoints has now been proven beyond doubt. These data may be reviewed on-line at: http://weisenthal.org/oncol_t.htm. The issues and data are also available in a 27 minute video excerpt of my testimony before an official Medicare technology assessment committee meeting in Baltimore.

Regarding the “expense” part of it. The tests cost in the neighborhood of $2,000, so it’s a legitimate consideration, but expense has to be put in context. A couple of quick examples:

1) A patient was an ovarian cancer patient with primary resistance to paclitaxel/carboplatin who then underwent tandem stem cell transplant/high dose chemotherapy regimens (at a cost of more than $250,000) without ever achieving a response. At a time when she had bulky, non-cytoreducible abdominal and pleural disease, CCDRT confirmed resistance to single agent cisplatin, carboplatin, and gemcitabine, but good activity for the gemcitabine/carboplatin combination. She subsequently received gemcitabine/carboplatin as an outpatient, achieved a durable complete response, and returned to work full time as an oncology nurse, where she remained well, for four years. The cost of ineffective therapy for this one patient alone would have paid for 125 assays.

2) One of our most “loyal” referring oncologists is financially independent and therefore he is free to manage his patients without any conflicts of interest relating to the fact that prescribing chemotherapy instead of counseling against it has financial repercussions to the oncologist and prescribing certain forms of chemotherapy over certain others likewise has financial repercussions. In the absence of information that some drugs are more likely than others to work, it is “ethical” to choose more remunerative forms of chemotherapy. The assay presents great problems for non-independently wealthy oncologists, because they take away their freedom to choose. The above oncologist recently told me of an interesting anecdote. He had a patient scheduled to come to his office on a recent Wednesday for chemotherapy. This treatment would have earned the oncologist $6,000 for a single patient, for a single afternoon’s worth of treatment. But the patient missed the appointment. The next day was the beginning of the oncologist’s vacation. So he had to arrange for the patient to be treated at the nearby, world famous, NCI-designated comprehensive cancer institute, which billed $28,000 for the treatment and which received 75% of this total (the oncologist knows this, because it had happened before).

The cost of drugs is enormous. And this is only part of it. Patients are “followed” with serial CT scans, MRIs, and even PET scans, just to ascertain if the tumor is growing or shrinking. And the hospitalizations for toxicity, etc. The point is that the cost of ineffective therapy is truly enormous, and the assays are particularly good at identifying ineffective therapy.

In summary:

There have been over 40 publications in the peer-reviewed medical literature showing correlations between cell death assay results and the results of clinical hemotherapy in more than 2,000 patients. In every single study, patients treated with drugs active in the assays had a higher response rate than the entire group of patients as a whole. In every single study, patients treated with drugs inactive in the assays had lower response rates than the entire group of patients. In every single study, patients treated with active drugs were much more likely to respond than patients treated with inactive drugs, with assay-active drugs being 7-9 fold more likely to work than assay-inactive drugs. A large number of peer-review publications also reported strong correlations between the assay results and the survival of cancer patients. These data are completely non-controversial and have
never been challenged or refuted. Thus Dr. Fry’s comment that “the killer was that the clinical response was not that well predicted by the cell survival tests in the lab” is absolutely incorrect.

The material on my website is very complicated (it is targeted to health professionals more than to laypersons). For a short overview of the most important issues, I’d recommend the Frequently Asked Questions section, which was also quoted by Wall Street Journal Health columnist Tara Parker-Pope in her weekly question and answer column appearing in the September 21, 2004 issue of the WSJ.

POLICY: The real costs of uninsurance, by Anonymous, with quick UPDATE

Every so often it’s worth remembering the human and economic costs behind our uninsurance statistics. The following TCHB contributor was employed and insured until about a year ago, but like many with her health condition cannot afford insurance now she’s uninsured. I’ve kept the author anonymous for obvious reasons, although she lives in the San Francisco East Bay, but read on and you’ll understand why there are economic costs for all of us from the uninsurance numbers:

I recently had my own health care crisis, and I thought I’d share it with you as something to ponder. I don’t have any context to put it in, so I will leave larger analysis to you. My basic reaction, though, is that as relieved as I am that I had access to good care, the whole process was utterly stupid from the taxpayer point of view.

A few weeks ago I had a large hemorrhage in one eye. This is a harmless condition for most people, but I was worried because I have an underlying genetic condition that causes a form of macular degeneration, and I was worried about hemorrhaging that I couldn’t see in the area of my retina. If this was the case,time was of the essence if I didn’t want to lose a chunk of my vision.

It was 2am when I discovered the problem. I’m uninsured, but I knew that an ER would have to treat me. I walked to Alta Bates in Berkeley. As a pathetic side note, I went to the wrong Alta Bates campus – I then had to walk to the Alta Bates with the ER (on Ashby). By the time I got there, I had a lot of pain in my legs (the same genetic condition causes claudication), and I had trouble explaining to the nurse that while I was limping and in tears, this was normal for me and was not why I needed to see a doctor. 🙂 The only reason I’m relating this is that I don’t think many people think about how poor people go through to actually get to the ER in the middle of the night in the first place.

I was treated very well as a person at Alta Bates. They didn’t make me feel uncomfortable about my lack of insurance at all. They gave me charity forms to fill out. I waited 5 hours to be seen, which turned out to be normal for both Alta Bates and Highland. The initial doctor I saw at Alta Bates did not give me adequate care. She glanced at my eye and told me there was nothing to worry about with that sort of hemorrhage. Since I provided information on my underlying condition up front, she should have given me a thorough eye exam. This visit cost the taxpayer $356.00 for the ER plus whatever the physician fee is (probably around $200.00).

I know enough to test my eyes myself, so the next day I tested myself. My vision was distorted. I tested over and over again just to make sure: I certainly didn’t want to go through the ER experience again. But the tests were always the same, so I went back to the ER. That’s a second $356.00 (possibly more for ophthalmology set up) plus the physician fee. This time Alta Bates gave me an urgent referral to Highland Hospital. Highland has an ophthalmology clinic, and a program for indigent patients. Highland, however, didn’t want to take the referral. It was written on my aftercare instructions instead of the form they wanted. I called Alta Bates to ask for the right form, and they insisted I was holding the referral. I called back and forth all day. Alta Bates finally faxed the referral, and Highland said it would
be at least three days before they could verify they even got the fax(!). This referral had urgent written on it because the Alta Bates physicians thought I needed to see a specialist fairly quickly. At one point I called Berkeley Free Clinic to see if I had any other county health system options for ophthalmology. Highland unfortunately was the only place for me to go.

An Alta Bates nurse then advised me to go back to Alta Bates, get a copy of my medical records, and go to Highland Urgent Care so a Highland physician could refer to the ophthalmologist. That’s right: my THIRD 5-hour emergency room visit for the same problem. The taxpayer was unnecessarily triple-billed because of some bureaucratic issue.

With travel, the trip to Highland took a spectacular 9 hours all together (I’d never been there, and two successive bus drivers forgot to tell me where the stop was). Once again, I have no complaint about my treatment as a human being. I described my situation, and the insurance person didn’t bat an eye. She just gave me the forms to fill out.

I was also very well treated by the triage nurse at Highland. After I told her about the problem with the referral, she physically tried to run after the on-call ophthalmologist. I almost lucked into seeing him right then and there, but he had to go into surgery. He did however give the triage nurse an appointment for me on the spot.

A morning later, I took another trip to Highland. The wait in the ophthalmology clinic was down to an hour. The ophalmologist gave me some tests, took a look at the area of my eye that was the source of distortion, and confirmed it wasn’t actively bleeding. (Keep in mind that I had gone through the past few days under continual fear that I might be losing my sight minute by minute). So, big relief. He thought the distortion was being caused by blood vessels and/or related scarring. It might have actually been there for months: I just never noticed it without the tandem visible hemorrhage. As a member of the uninsured, I had not had access to regular ophthalmology checks that are really necessary for someone in my condition.

Perhaps an economic analyst like yourself might realize that the public issue here is that denying me health care in the first place (especially in a frivolous “specialty”) means that the taxpayer gets to pay long term when I’m permanently disabled.

While I wasn’t in an acute situation, my vision was still damaged. The ophthalmologist referred me to a retinal specialist at Summit. This retinal specialist was supposed to give me an angiogram to show whether blood vessels were the issue, and whether my vision could be helped or at least prevented from deteriorating by laser surgery.

The good news for me as an indigent patient is that I was sent to the same retinal specialist that anyone else would go to. The bad news for the tax payer is yet another weird system disconnect occurred. I went to the retinal specialist, but I didn’t get the angiogram. I got the exact same eye exam I got from the ophthalmologist instead. Afterward, the retinal specialist gave me a rerun of the angiogram and laser surgery talk. He needed to schedule me for another appointment for those. The appointments system was down so the nurse was supposed to call me. My phone is sketchy, so I gave my email as well. It’s been a few days, and I haven’t been contacted by either phone or email. I plan to call after I finish this note.

So many things have been surreal about this entire situation. I was honestly surprised that the people dealing with the insurance forms were all non-judgmental and dealt with me in private. This would not have been the case in my home state of Virginia, where the economy is regulated through shame. 🙂

On the other hand, the actual medical care varied, and it required a lot of proactive work on my part (to negotiate between Alta Bates and Highland). This was difficult for a fairly well-educated and strong person like myself: I wonder what happens to people who are more docile or more acculturated to conditions of poverty. I thought that the first doctor in the Alta Bates ER should have taken a closer look at me, but all the other doctors I saw were great.

It was also stressful to go through all the bureaucratic hassles at a time when it was possible that every minute could be costing me more of my sight. The initial trip to the Alta Bates ER actually gave me a fever – some sort of shuttle between hospital campuses would have been nice. Also, I had to deal with a guy following me and making catcalls as I made my way back home in the wee hours of the morning.

Finally, the redundancy was mind-boggling. It’s a good thing I don’t work at all, because I literally spent half my week in hospital waiting rooms. If I were temping at the time, I would have been out of a job that at this point I would be desperate to cling to. I appreciate that no one cares about the wasted time of a non-entity such as myself, but when you realize that each trip was a *separate* bill to the taxpayer, it might be time to start considering this as a social issue.

This story is not over yet: I need to go back to the retinal specialist, and then probably some laser thing after that. Hopefully, there won’t be any further adventures in nonsense. I will try to remember to let you know if I get to a point where I can total up a final bill.

The only point that is not accurate here is that the taxpayer per se won’t get these bills–they’ll probably be marked down as charity care, after the hospital makes some level of effort to get the money out of the patient. And of course $350 is the rack rate for an ER visit, not what a local health plan would pay. But in the end, we’re all picking up the tab for this foolishness–now and in the future.

UPDATE: The Sunday Boston Globe had an article about a guy who played the uninsurance gamble and lost, and now has to pay Mass General $40,000, where an insurer would have paid them $7-10,000. The key part is that he’s paying off his bill to the General at $700 a month — which is what insurance from Blue Cross would cost him. Prize to the first person who can email me the 5 counteracting incentives in the whole system this article details without having their head explode.

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