We’re Number 1 –The Most inefficient Health Care System in the World

It’s fascinating to see the “free market” system in action. Looking and finding for ways to gain an advantage is a major part of how it works. It’s not pretty and it doesn’t result in cost savings and efficiency as we already know from the various banking crises, Enron, Worldcom etc, etc.

In healthcare the results of allowing businesses to operate without regulation (no anti-trust rules for these operations) has consequences. From the Washington Monthly a sobering story about medical supply group purchasing organizations:

Originally, these purchasing groups were nonprofit collectives and were managed and funded by the hospitals themselves. But in the mid-1970s, the model began to shift. Some large hospital chains started to spin off for-profit GPO subsidiaries, which other hospitals could join by paying membership dues, much the way members of buying clubs like Costco pay dues to get bulk-buying discounts. By decade’s end, virtually every hospital in America belonged to a GPO.

Then, in 1986 Congress passed a bill exempting GPOs from the anti-kickback provisions embedded in Medicare law. This meant that instead of collecting membership dues, GPOs could collect “fees”—in other industries they might be called kickbacks or bribes—from suppliers in the form of a share of sales revenue.

But, as with many well-intended laws, the shift had some ground-shaking unintended consequences. Most importantly, it turned the incentives for GPOs upside down. Instead of being tied to the dues paid by members, GPOs’ revenues were now tied to the profits of the suppliers they were supposed to be pressing for lower prices.

Kiani’s testimony was followed by a flood of revelations about self-dealing and conflicts of interest among GPOs and their executives. Congress was also given a slew of documents showing that GPOs were collecting upfront payments of up to $3 million from suppliers, including drug makers like Astra-Zeneca, in return for awarding them sales contracts, not to mention a large share of revenues. In one case, a vendor was handing Novation not 3 percent of its revenue on a given product line, but a full 94 percent, according to Novation documents

As for independent assessment of GPOs’ effect on costs, they are hard to come by. But the little information that is available suggests that they may actually drive up the price of supplies. A 2002 pilot study by the Government Accountability Office found, for instance, that hospitals that went through GPOs paid more for safety needles and most models of pacemakers than those that negotiated prices on their own—for some pacemakers the median gap was as wide as 39 percent.

Medicynical Note: The natural consequence of a “free unregulated market” appears to be corruption–in the broad sense. Guess who pays?


An Economy Based on Health Care is SICK

It’s bizarre when a major driving force of an economy is health care that most people can’t afford.

On June 21, the AHA released its “Economic Contribution of Hospitals” report. The AHA said the health care sector, of which hospital care is the largest component, added $2.3 trillion to the U.S. economy in 2008, or 16.2% of gross domestic product. Hospitals accounted for $718 billion of that total; employed more than 5.3 million people, including physicians; and spent about $320 billion on goods and services from other industries, according to AHA data. The Bureau of Labor Statistics puts hospital employment figures at 4.7 million nationally as of May 2010.

link: amednews: 1 in 9 jobs supported by hospitals, AHA says :: July 5, 2010 … American Medical News

Medicynical Note: All manner of opportunity here, heal thyself, our “ailing” economy, etc. The most optimistic one might view our aging population with increasing needs for health care as an opportunity for economic growth–that’s just plain sick!

Those people expecting a quick, or even slow, resolution of our economic woes by “cutting taxes”, “stimulating” by spending or moving to a “market” driven economy are on simply delusional. There are structural problems here fueled by greed, unreasonable expectations of wealth and world hegemony and a flawed economic base.


The Dark Side of Medical Tourism

In cancer care for inexplicable reasons patients often travel to Mexico for alternative treatments, that inevitably fail. In 40 years, I’ve never seen a patient with documented cancer who benefitted.

The choice of Mexico is certainly not for quality or necessarily because the patient is a fan of “alternative medicine” but rather is often dictated by our poor non-system of health care and excessive costs. It can be risky as this patient learned.

“In the United States the lowest quote I got was $24,000.00 for the surgery and in Mexico,” [she] said. “I was getting quotes of $12,000.00 to $14,000.00 and I ended up paying $12,500.00.” But it was no bargain–since the April surgery she’s been to the emergency room three times. Larissa said she’s been told she needs surgery or she’ll slowly die. “I don’t have any more money, I don’t have insurance and [surgeons here] don’t want to take on somebody else’s mistakes.”

Medicynical note: Shopping for health care presumes that the non-emergent nature of the problem allows time to shop. It also requires availability of alternatives, and finances and/or insurance that will cover the cost. The final factors are knowledge of the skill, training and expertise of the chosen facility and awareness of the medical problem, treatment alternatives and their cost/effectivness.

Most people don’t have the time, access (locale or finances) or knowledge to “shop” for care and/or become a medical tourist. Lots of opportunities here for the unscrupulous and poorly trained to take advantage.


Commonwealth Fund Report on Health Care–US is last

Check out the ratings and cost of Health Care here compared with Australia, Canada, Germany, Netherlands, New Zealand, and UK.

It is apparent that the U.S. is lagging in adoption of national policies that promote primary care, quality improvement, and information technology. Health reform legislation addresses these deficiencies; for instance, the American Recovery and Reinvestment Act signed by President Obama in February 2009 included approximately $19 billion to expand the use of health information technology. The Patient Protection and Affordable Care Act of 2010 also will work toward realigning providers’ financial incentives, encouraging more efficient organization and delivery of health care, and investing in preventive and population health.

For all countries, responses indicate room for improvement. Yet, the other six countries spend considerably less on health care per person and as a percent of gross domestic product than does the United States. These findings indicate that, from the perspectives of both physicians and patients, the U.S. health care system could do much better in achieving value for the nation’s substantial investment in health.

Medicynical Note: We will need to improve our non-system’s inefficiencies and develop an approach that provides value, maintains quality, and improves access. The Patient Protection and Affordability Act of 2010 is an important first step. The question is whether our democracy, while in economic crisis, has the will to do this.


Mylotarg removed from market –Expensive targeted agent didn’t improve survival

This drug was approved in 2000 through the FDA’s expedited release program. For what it’s worth, it was not approved for use in Europe because of several studies showing “only a small proportion” of patient’s achieving complete remission while on the drug and the lack of comparisons with other treatments.”

In the non randomized studies of 277 patients that led to U.S. approval in 2000:

The overall response (OR) rate for the three pooled monotherapy studies was 26% (71/277) consisting of 13% (35/277) of patients with CR and 13% (36/277) of patients with CRp (remission but platelets remain low). The median time to blast clearance in both CR and CRp patients was 28 days from the first dose of Mylotarg. The median time to remission was 60 days for both CR and CRp. Remission rates are shown in Table 1. Of the 157 patients who were ≥ 60 years old, the overall remission rate (OR = CR + CRp) was 24%. For the patients < 60 years old and all 277 patients the OR rates were 28% and 26%, respectively.

IN SMALL Print it is noted:

The median overall survival was 3.3 months for NR (not responding) patients; in all 277 patients it was 4.9 months. (Medicynical emphasis: a 1.6 month benefit)

The approval in 2000 was conditional on further studies being done. These studies have now been analyzed and the results show:

The five-year Mylotarg study released in December didn’t show benefit in response rate, disease free survival or overall survival in 627 previously untreated patients ages 18 to 60. Deaths possibly related to treatment were reported in 1.4 percent of patients taking standard therapy and 5.7 percent of patients with Mylotarg added to therapy, according to an analysis by the Southwest Oncology Group, one of the largest clinical trials cooperative groups supported by the National Cancer Institute.

Medicynical Note: This is bad news for elderly acute myelogenous leukemia. Trials of new drugs often show better results in initial studies than in later ones. The reason for this is not fully understood. Some drugs that on reevaluation were not as useful as previously thought include the various types of erytropoietin and estrogen hormone replacement therapy.

Sadly with the industry aggressively marketing new marginally effective drugs this type expensive result, both in terms of patient outcomes and cost, will be repeated in the future.


More Conflicts of Interest–Zimmer Holdings and Dr. Berger

After receiving 8 million dollars from Zimmer Holdings an orthopedic implant maker guess whose devices Dr. Berger recommended–until they began to fall apart in patient’s bodies.

For years, Dr. Richard A. Berger designed surgical tools and artificial joints for Zimmer Holdings, trained hundreds of doctors to use its products and talked it up wherever he went. In return, Zimmer, an orthopedic implant maker, helped enrich Dr. Berger, portraying him as a master surgeon and paying him more than $8 million over a decade.

Amid the booming use of artificial joints in the United States, the breakup between Dr. Berger and Zimmer highlights what experts say is a troubling situation for patients and doctors: when disputes arise about orthopedic implant safety, there are no independent referees or sources of information because no one tracks the performance of the devices.

Medicynical Note: This is not just the appearance of a conflict of interest. Patients are a nuisance to these guys, simply a means to huge earnings. Quality of care? Value? Ethics? Guess who pays?


Medicare Cuts=More Chemotherapy

It’s enough to make a Medicynic’s day.

The Medicare Prescription Drug, Improvement, and Modernization Act, enacted in 2003, substantially reduced payment rates for chemotherapy drugs administered on an outpatient basis starting in January 2005. We assessed how these reductions affected the likelihood and setting of chemotherapy treatment for Medicare beneficiaries with newly diagnosed lung cancer, as well as the types of agents they received. Contrary to concerns about access, we found that the changes actually increased the likelihood that lung cancer patients received chemotherapy. The type of chemotherapy agents administered also changed. Physicians switched from dispensing the drugs that experienced the largest cuts in profitability, carboplatin and paclitaxel, to other high-margin drugs, like docetaxel. We do not know what the effect was on cancer patients, but these changes may have offset some of the savings projected from passage of the legislation. The ultimate message is that payment reforms have real consequences and should be undertaken with caution.

And:

“Physicians don’t always respond to incentives the way most people expect, but in this case they do respond in a way that makes sense to economists. It seems logical on the one hand that when you pay less, you get less. However, in this case, since a high proportion of an oncologist’s income depends on prescribing, paying less per drug results in more drugs,” study first author Mireille Jacobson, of the non-profit RAND Corp., said in the news release.


Tasigna — Another good drug for CML

Tasigna was recently (June 17,2010) approved for Philadelphia chromosome positive CML (Chronic Myelogenous Leukemia). You may be aware that CML is an unusual malignancy in that there is just one gene mutation with a number of minor variations–reciprocal translocation between chromosome 9 and 22 designated as t(9;22)(q34;q11). This tranlocation is occasionally found in acute lymphoblastic leukemia and acute myelogenous leukemia.

Having a single target appears to make the disease more susceptible to targeted drug intervention.

BCR-abl activates tyrosine kinase cell division controllers speeding up cell division and ultimately may cause blast crisis through the resulting genetic instability.

In the 90’s imatinib (Gleevec) was identified as active in CML blocking tyrosine kinase inhibitors. While not curative the drug resulted in immediate dramatic improvement in survival for CML patients. Some patients however in time became resistant and there are several newer tyrosine kinase inhibitors on the market that appear to work in these Gleevec resistant patients. Tasigna is one.

This is from the FDA:

The efficacy and safety of nilotinib in adults with newly diagnosed CP-CML was demonstrated in a single randomized, active-control, open-label multinational clinical trial. Eight hundred and forty-six patients were randomized to imatinib 400 mg QD (n = 283), nilotinib 300 mg BID (n = 282), or nilotinib 400 mg BID (n = 281). The primary objective was to compare the rate of major molecular response (MMR) at 12 months of nilotinib 300 mg BID and nilotinib 400 mg BID with that of imatinib 400 mg QD. MMR was defined as a ≤0.1% BCR-ABL/ABL % by international scale measured by RQ-PCR, which corresponds to a ≥3 log reduction of BCR-ABL transcript from standardized baseline. The rate of complete cytogenetic response (CCyR) by month 12 was the key secondary endpoint.

The primary efficacy endpoint, MMR at 12 months, was achieved in 63 patients [22% (95% CI: 18, 28)] in the imatinib arm, 125 patients [44% (95% CI: 38, 50)] in the nilotinib 300 mg BID arm, and 120 patients [43% (95% CI: 37, 49)]

In the nilotinib 400 mg BID arm. The differences were statistically significant

(p < 0.0001) for each nilotinib arm compared to the imatinib arm. CCyR rates by 12 months were 65% (95% CI: 59, 71) for the imatinib arm, 80% (95% CI: 75, 85) for the nilotinib 300 mg BID arm and 78% (95% CI: 73, 83) for the nilotinib 400 mg BID arm.

Medicynical Note: This is an example of a class of drugs, tyrosine kinase inhibitors, that are very effective but very expensive. To control CMS requires continued treatment often for many years at a cost approaching $100,000/year.

To return to a theme, this exceeds our average yearly and median incomes. Charging more for a single item that has become a necessity of life than the great majority of the population earns is unique to pharmaceuticals. Which in a way speaks volumes of our values?

It will be interesting to see if Tasigna is priced more reasonably. Consider that this drug was approved, as was Gleevec after a single clinical trial. And in the case of Gleevec much of the early research funding came from you and me through federal grants. I rather doubt we’ll see responsible pricing.

Drug pricing by any measure in our country is excessive and shows little signs of moderating. Our elected representatives appear to be handsomely rewarded for their support of the industry with large campaign contributions.

We need to look at patents and provide a market based means to reward companies that price drugs reasonably. We need to look at our insurance industry and their lax controls over drug expenditures. Providing cost efficacy studies on all these prohibitively expensive agents would help as well–but who will do them?


Cost an QALY Studies at 2010 AXCO

In review of the over 5000 abstracts presented at the recently concluded ASCO 2010 meeting, just 169 reports contained the word cost or costs.

Of these only 52 look at cost effectiveness. Most of these aimed at documenting cost rather than evaluating effectiveness.

Just 19 studies used the widely accepted QALY estimation to evaluate the cost effectiveness.

Of these 19 abstracts just three looked at the effectiveness of new targeted treatments, the most expensive medications ever marketed. These drugs cost more than the median and average income of U.S. citizens and one would have thought there would be interest in checking out the value of these advances.

The following are the three abstracts looking at cost-effectiveness:

Abstract # 6037 Cost-effectiveness of lapatinib plus capecitabine (LAP+C) versus capecitabine alone (C-only) or trastuzumab plus capecitabine (TZ+C) in women with HER2-positive metastatic breast cancer (MBC) who have received prior therapy with trastuzumab (TZ) from the U.K. National Health Service (NHS) perspective. British National Health Service

This study looked at time to progression and costs of the various regimens and then extrapolated from other studies survival data to provide cost effectiveness data. For the addition of lapatinib to capecitabine (the “standard treatment) the QALY was found to be 77,996 british pounds or about $109,000.

Abstract 3623 Cost-effectiveness analysis of the addition of bevacizumab to first-line chemotherapy in metastatic colorectal cancer. British Columbia Cancer Agency

Results: 943 patients were included: 611 from 2003/04 (pre-Bev era) and 332 from 2006 (Bev era). Median overall survival improved from 15.6 months in the pre-Bev era to 19.5 months in the Bev era (p=0.03). The weighted average cost of treatment per patient was $34,972 and $38,764 in the pre-Bev and Bev eras, respectively. In the Bev era, the cost of treatment resulted in an incremental cost-effectiveness ratio of $15,617/LYG, which translates into $62,468/QALY gained. Probabilistic sensitivity analyses produced an interquartile range of $38,900-$85,800/QALY, suggesting that the model is sensitive to the cost of systemic therapy. Conclusions: Even though Bev incurs in a high acquisition cost, it has also improved the cost-effectiveness of systemic therapy during the era in which it has been used.

link: Cost-effectiveness analysis of the addition of bevacizumab to first-line chemotherapy in metastatic colorectal cancer.


Abstract 1035: Indirect comparison of the cost-effectiveness of letrozole plus lapatinib (LET+LAP) versus anastrozole plus trastuzumab (ANA+TZ) as first-line treatment for postmenopausal women with HER2+ and HR+ metastatic breast cancer (MBC) from the U.K. National Health Service (NHS) perspective.

Shown in the Table (all results are discounted). LET+LAP yields more progression-free life years (PFLYs), life years (LYs), and QALYs than ANA+TZ. Medication costs are greater with LET+LAP, partly due to longer PFS. These higher costs are offset by savings in costs of drug administration. LAP+LET is therefore dominant (less costly and more QALYs) versus ANA+TZ. Conclusions: Letrozole plus lapatinib has greater effectiveness and lower cost from the U.K. NHS perspective when indirectly compared with anastrozole plus trastuzumab. Medicynical Note: The problem with this study is that the incremental benefit, cost effectivenenss, of trastuzumab in breast cancer is open to questionThe addition of trastuzumab to capecitabine is estimated to cost on average an additional of €33 980 and to yield a gain of 0.35 quality-adjusted life years (QALYs), resulting in an incremental cost-effectiveness ratio of €98 329/QALYs gained. Probabilistic sensitivity analysis showed that the willingness-to-pay threshold of €60 000/QALY was reached in 12% of cases.” You read that right a gain of .35 QALY’s for about $50,000. The question is whether any health care system can afford such expensive drugs.

Medicynical Note: Given that our health care system is number 1 in the world in inefficiency, one would have thought there would have been a number of studies from the U.S. evaluating cost efficacy. At this meeting there appears to have been no study of these high cost drugs from a U.S. institution. On second thought maybe there is a nexus here.

Unfortunately, in a “market” driven system with no checks on costs, no one is really interested in value. Our insurers, doctors and technology suppliers simply charge what they can/wish and pass the costs on to consumers, without regard for efficacy or cost. We need a brake in the system. It’s open to question whether the new health care law will provide it. What a non-system.


This is a Health Care System?

Doctors with Medicare patients will start seeing a 21 percent pay cut this week after Congress failed to defer the cuts by two more years.

link: Doctors face 21 percent cut in Medicare payments

One in five medical claims is processed inaccurately by commercial health insurers, often leaving physicians shortchanged, according to the nation’s largest doctor’s group.

link: The Associated Press: Doctors’ group wants more accuracy from insurers

An out-of-work Michigan woman shot herself in the hope she’d receive medical treatment for a shoulder injury.

link: Michigan Woman Shoots Herself to Get Medical Attention – Incredible Health – FOXNews.com

Millions of cancer survivors have put off getting medical care because they couldn’t afford it, according to a new study.

link: Nation & World | Millions of cancer survivors put off care over cost | Seattle Times Newspaper

Medical costs for U.S. employers will rise by 9 percent in 2011, slightly less than they have risen this year, according to a survey released on Monday. Medicynic: This is progress? Salaries haven’t increased in 10 years. Something’s radically wrong.

link: Rise in employer healthcare costs slowing: survey | Reuters