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In a monetized health care system profits not health care are the goal. I’ve been critical of our pharmaceutical industry because their pricing is predatory and not related to their actual costs of development. (See previous posts on drug costs)

The NYTimes today documents further the extent that these companies will compromise standards in order to maximize profits. It even surprises me. Check out the picture in the article of one of PHARMA’s suppliers.

“A hugely popular blood thinner used in surgery and dialysis, heparin turned out in some cases to contain a mystery substance that sophisticated lab tests earlier this month determined to be a chemically modified substance that mimics the real drug. The United States Food and Drug Administration has linked it to 19 deaths and hundreds of severe allergic reactions, though the agency is still investigating whether the contaminant was the actual cause.”

“We can blame the Chinese for this stuff as much as we want, but the truth of the matter is we are the people who are buying,” said Joseph G. Acker, president of a chemical trade association.”

Amazing.

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Medicare, unlike health programs in virtually all other industrial nations doesn’t explicitly consider cost effectiveness in it’s health decisions.

“The reasons for Medicare’s resistance to the use of cost effectiveness analysis are many and include America’s affinity for new medical technology, a distaste for explicit limit setting, a sense of entitlement with regard to Medicare funds, the perception that in a vast and wealthy country, health care resources are not really constrained, a political system in which interest groups wield enormous influence and a splintered and pluralistic health care system in the United States in which no single payer is responsible for allocating resources for health care.” ( From: Neumann et al. NEJM 2005;353: 1516-1522.)

I regularly attend our local hospital’s tumor board. It’s amazing how quickly very costly agents have been adopted into the oncology medical practice, regardless of cost and effectiveness. These drugs include Trastusumab (Herceptin), erlotinib (Tarceva), bevacimab (Avastin), cetuximab (Erbitux), paniturmumab (Vectibex).

These drugs in controlled studies seem to have limited efficacy (lung, colon, or breast cancer) about 1 to 2 months and high costs. For example, this estimate of efficacy of panitumumab :

“The mean time to disease progression or death in patients receiving Vectibix was 96 days versus 60 days in patients receiving the best standard supportive care. In addition, 8% of the patients on Vectibix experienced a tumor shrinkage that in some cases exceeded 50% of the pre-treatment size of the tumor. Both study groups showed similar overall survival.” Medicynical note: That means while there was some activity there was no significant significant extension of life (i.e. no survival advantage)

Given minimal efficacy of some of these new agents, I wondered whether my experience is a local aberration or indicative of a general trend. Is medical oncology at all interested in cost/efficacy data? Looking at the last 4 years of abstracts from the annual meeting of the American Society of Clinical Oncology (ASCO) the following was noted.

At ASCO’s annual meetings between 2004 and 2007 there were just 37 (2004), 27 (2005), 35 (2006), and 41(2007) presentations with the word cost in the title–less then 1% of presentations.  Many of these studies were about the cost of complications, non-compliance, and non-cost evaluative studies erroneously labeled as such. Many of the other studies were from overseas and not applicable to the U.S. experience. Of the cost efficacy studies done in the U.S. only a handful dealt with the newer high cost biological agents. These included the following:

1. A metananalysis of cost studies regarding trastuzumab (Herceptin), used in Her 2 neu positive breast cancer patients ,(about 20% of all breast cancer cases) from 2003 to 2005 showed:

“The median cost per patient treated was calculated €44,196 yielding costs per life year saved in the range between €63,137 – €162,417 (medicynical note: one euro is currently worth about U.S. dollars $1.50) depending on survival gain and discount rate employed. A sensitivity analysis documented the price of trastuzumab and the survival benefit the two major factors influencing the cost-effectiveness ratio. Conclusions: The economic evaluation indicates trastuzumab not cost effective in metastatic breast cancer. Reduced drug costs and/or improved survival may alter the conclusion”

Other studies of trastuzumab (Herceptin) were mainly done in Europe where costs are significantly less than here. One U.S. study from 2006 revealed

“ Over a 20-year horizon, addition of H (trastuzumab) to AC (adriamycin and cytoxan) is estimated to cost an additional $46,300 on average, with an expected gain of 1.28 QALYs (Quality Adjusted Life Year) -a cost/QALY of $36,100. The key drivers of CE are the cost of treatment and the improvement in DFS. “ medicynical note: QALY is roughly equivalent to the YLG, year live gained, data below) In this study the use of trastuzumab was considered cost effective in that it’s costs were less than the arbitrary cost/QALY of $50,000-$100,000 that appears to be generally accepted.

2. Regarding erlotinib (Tarceva), it is approved by the FDA for lung cancer and pancreatic cancer. In lung cancer it has be found to increase life by about 2 months versus placebo treatment. One abstract evaluating it’s cost effectiveness, done by the manufacturer, assumed equal survival with standard chemotherapy and was not based on randomized trials or actual patient survival data.

In pancreatic cancer, a 2006 abstract reported:

“The addition of erlotinib increases cost by $12,156 wholesale or $16,613 retail. Given an increase of 0.4 months in median survival over gemcitabine alone, the addition of erlotinib costs $364,680 per year of life gained (YLG) wholesale and $498,379/YLG retail.” Medicynical note: despite the finding the FDA has approved this drug in pancreatic cancer.

3. Bevacimab (Avastin), an antiangiogenic medication, has been approved for use in colon cancer, lung cancer and most recently breast cancer.

A 2006 abstract evaluated it’s cost effectiveness in lung cancer:

“The addition of bevacizumab increases cost by $66,270 to $80,343. Given an increase of 2.3 months in median overall survival over chemotherapy alone, the addition of bevacizumab to chemotherapy costs $345,762 per year of life gained. Conclusions: Adding bevacizumab to chemotherapy is not cost effective even at the $100,000 per Year of Life ” medicynical note: This drug is widely used for lung cancer.”

And in 2007 this was noted:

“Total direct medical cost estimates were similar for bi-weekly FOLFOX4 and 3-weekly XELOX: $45,800 vs. $44,500. XELOX had higher drug costs while FOLFOX had higher drug administration costs, with about 15 more visits. Costs for hospitalization and ambulatory encounters were slightly lower for FOLFOX4; other medications and venous access were slightly higher for FOLFOX4. Similar patterns held for FOLFOX4+bev vs. XELOX+bev (total direct medical cost estimates $76,100 vs. $79,200).” medicynical note: FOLFOX4 and XELOX are traditional chemotherapeutic regimens for details check the abstract.

The treatment results of the above study reported in the ASCO GI conference of 2007 reported:

“PFS (progression free survival) for XELOX-Bev + FOLFOX4-Bev was 9.3 months vs. 8.0 months for XELOX-Pla + FOLFOX4-Pla (p=0.0023, HR 0.83, 97.5% CI, 0.72-0.95). Median PFS on specified study treatment was 10.4 months for chemotherapy + Bev vs. 8.1 months for chemotherapy + Pla (HR 0.63, p<0.0001).”

This means that at an added cost of $30,000-40,000 the patient’s survival improved between 1.3 and 2.4 months when compared with placebo used instead of bevacizumab. My estimate of the cost/year of life gained is $150,000 to $360,000, far in excess of the usual cost effectiveness marker. Not particularly impressive, though it is a incremental step forward. Worth the money?

4. There were no cost studies in the period on the use of cetuximab.

I conclude that there is an indifference to cost efficacy data that is endemic to our system. It appears that no one including Medicare, researchers and practitioners seriously considers cost/efficacy when using exceptionally expensive agents.

Patients are not cured with these drugs, do not have exceptional responses and if used they will not predictably markedly improve outcomes–as they will predictably markedly increase expenses. We need more cost efficacy studies done in an objective manner and a system in which their findings are factored into treatment choices. Indeed, the FDA and/or insurers should not approve such drugs for wide use until such studies are done.

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We have been so insensitive to the costs of health care that only now after costs have skyrocketed to the $100,000/year and more for a single drug do we think we need to mention it to patients. Doctors are now being prompted and coached on how to talk to patients about costs.

“Chemotherapy costs are rising so dramatically that later this year, oncologists will get their first guidelines on how to have a straight talk with patients about the affordability of treatment choices, a topic too often sidestepped.”

Other interesting comments from the article:

“Drug prices are a growing issue for every disease, especially for people who are uninsured. But cancer sticker shock is hitting hard, as a list of more advanced biotech drugs have made treatment rounds costing $100,000, or more, no longer a rarity. Also, patients are living longer, good news but meaning they need treatment for longer periods. The cost of cancer care is rising 15 percent a year”–Medicynical note: that’s $100,000/year

“Gleevec, for example, has revolutionized care for a type of leukemia — and the prices reflect manufacturers’ years of research and development investment.” Medicynical note: Gleevec (imitinab) is an interesting example. It was largely developed with tax payer financed research. Development costs were minimal because it was such a major improvement over previous medications for chronic myelogenous leukemia–only a handful of small studies were necessary to prove safety and efficacy. Yet the drug costs in the range of $50,000-$100,000/year depending on the diagnosis and stage of the disease.

Health care costs are the leading cause of personal bankruptcy in the U.S. (data prior to current mortgage crisis).

Do you think that cost is affecting care? What are the ethics of this situation? Does the system have an obligation to assure patients access to the best treatment? What is best? Would you believe that cost efficacy (assessments of efficacy and value) is not considered by Medicare in it’s coverage? Is this a problem?

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America’s medical technology development and use leads the world. We spend more on technology than any other country. That’s one of the reasons why our healthcare costs are higher. But it has not helped our outcomes. Uwe Reinhardt’s comments may explain:

“Reinhardt also discussed the challenge of what he referred to as the “widening income distribution in the U.S., which makes it ever harder for families in the bottom 30 percent to 40 percent of the nation’s income distribution to afford modern American health care, including the many wonders the members of AdvaMed invent and produce.” He further stressed that this income disparity argues the need for enactment of comprehensive health care reform, a position reflected in AdvaMed’s own health care reform plan.”

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It’s fascinating, these drugs have been around for about 15 years. They were never thought to improve disease survival and were marketed aggressively directly to consumers as well as physicians as medications that help people cope with their treatment. (“Ask your doctor about ………”) Now we find “they can increase the risk of death and tumor growth.”

The companies involved have made billions of dollars on these medications, they were expensive and given on a regular basis throughout the treatment cycle. It’s hard to believe that no one along the way seriously considered the possibility that the drugs might worsen prognosis–I know it was a consideration in hematologic malignancy.

In other countries their use was limited because of their cost and because the countries negotiated their prices were lower.

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This article from the Washington Post is one of the best in explaining the health care disaster we are facing. It is a perfect storm of increasing expectations, increasing costs, and stagnant income.

Some interesting tidbits:

” Since 2001, premiums for family health coverage have increased 78 percent, according to a 2007 report by the Kaiser Family Foundation. Premiums averaged $12,106, of which workers paid $3,281, according to the report.”

“Even though workers are producing more, inflation-adjusted median family income has dipped 2.6 percent — or nearly $1,000 annually since 2000.” (emphasis by medicynic)

“Nearly nine out of 10 firms that responded to a National Association of Manufacturers survey last year named the cost of health insurance as one of their top-three worries — ranking it higher than government regulation, competition from imports or finding qualified employees.”

The question is whether we can make a progressive change in health care and finally have a system that provides a basic mix of services to our people. We’ll see!

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There should be no dispute that patients control the distribution of their medical information. The world has changed and the “sacred” patient/doctor relationship no longer exists. We live in a world of islands of interactions often not well connected. Hospitalists take over care should you enter a hospital having never seen the patient previously and never to see the patient again. Insurers would like nothing better than to rate everything and charge for health issues even if not well documented–guilty until proven innocent.

I’m sympathetic to the patient who for whatever reason doesn’t want to have everything on their record revealed to anyone with access for all time. Perhaps some limitation will force the physician to spend more time with the patient and actually understand the patient’s problem, social milieu, and medical goals.

The question is how to implement such limitations.

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Amazing, I don’t have scruples about going to Canada for my medications but it is an inconvenience. That McCain won’t do anything about prices HERE is stunning.

The proposals to reward physicians for innovative care are fine but they doesn’t get to the crux of the efficiency/cost problem-the overuse of procedures and use of expensive treatments that don’t materially alter outcomes. The fact that Canada offers the same medications for a fraction of the cost is a telling indictment of our non-system of controlling costs.

We need to reevaluate technology and assure appropriate use; reward companies for right pricing of advances; penalize those who gouge customers (patients, providers and insurers); and decrease our duplicative terribly expensive administrative overhead.

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The notion that health costs increase disproportionately as a population ages is questioned in a study from Canada. They note:

“While aging is one factor driving up the health care tab, it plays a relatively small role compared to population growth, inflation and medical technology, says the think-tank. According to the report, the biggest factors pushing up costs are new drugs and diagnostic tools.”

The corollary of this finding is that we need to find a way to control the costs of new drugs and assure appropriate use of new technology, including new diagnostic tools.

It was also noted:

“Japan, which has among the world’s largest share of people aged 65 and older, spends less than eight per cent of its total wealth on health care. The U.S., with one of the lowest rates of seniors in the industrialized world, spends nearly double that amount. Canada, whose population of elderly falls in between, spends about 10.6 per cent of its total wealth on health care.”

What’s amazing is that we accept our inefficiency. Some even claim that our “system” is the best in the world when our costs far exceed and health outcomes lag behind those of other industrialized nations. We seem to encourage mediocrity.

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With the recent death of Judah Folkman there have been a number of articles touting the using of this drug in varied tumors. There is little doubt antiangiogenesis is an advance, but how much of an advance and can we afford it? Is two month’s survival benefit worth $50-$100,000 in expenditures for the drug alone?

Folkman’s research on anti-angiogenic agents was funded for many years (over 20 years) by you and me through NIH grants to the researcher. When agents were identified with activity they were taken private by pharmaceutical companies and developed for market.

Avastin, one of the agents related to his research, has been shown to have limited activity in an number of tumors when combined with traditional agents. In GI cancer it may extend life in advanced cases by about 2 months for about $4400/month. In advanced Lung cancer, there is a survival advantage of just two months at a cost of $7700/month’ Similarly in breast cancer, a disease for which no survival benefit from Avastin has been proven, the costs will be in this higher range. The FDA approval to use this very expensive agent in diseases with a limited or no no survival benefit is highly controversial.

Adding insult to injury the Times in a recent article reported on one single case of an ependymoma that may have responded to Avastin. It was suggested that this indicated amazing effectiveness, dispite the well known fact that ependymoma has a widely varied rate of progression and that one case does not prove efficacy.

Genentech the manufacturer has magnanimously created a program that limits charges to patients to $55,000/year if your income does not exceed $100,000/year.

The medication is not without side-effects they include: arterial thromboembolic events, congestive heart failure, GI perforation, hemorrhage, hypertensive crisis, nephrotic syndrome. neutropenia and infection, reversible posterior leukoencephalopathy syndrome, wound healing complications

Is it any wonder that our health care system spends 2 trillion dollars a year without improving outcomes?