Category Archives: Health Economics

Wide Variation in cost of Treating Colon Cancer

This article in the American Journal of Managed Care only tells half the story. It reports on the costs of chemotherapy for colon cancer using conventional chemotherapeutic agents. As reported common regimens costs are:

Total Cost of 6 Cycles of Commonly Prescribed Treatment Regimens

Chemotherapy Regimen Total Cost of Treatment ($)
5FU/LV (5-flurouracil plus leucovorin) 1,028
IFL/FOLFIRI (flurouracil/leucovorin/irinotecan) 38,027
FOLFOX (fluorouracil/leucovorin/oxaliplatin) 17,584
Irinotecan 25,287
CapeOx (capcitebine/irinotecan/oxaliplatin) 34,744
Oxaliplatin 11,593

Part of the wider variation in cost is the need for leukocyte stimulating factor (GCSF) and erythropoietin with the more aggressive regimens. Given the large difference in cost to the system one wonders why a historical comparison of the effectiveness of the various regimens was not included.

The study was completed in 2005 and the cost variation may be worse now:

“This variation is likely to be even bigger now that monoclonal antibodies, such as cetuximab (Erbitux) and bevacizumab (Avastin), have been accepted as standard therapies to be added onto chemotherapy regimens. The study finished at the end of 2005, and so did not assess the impact of these new products, Dr. Lyman explained. It focused on chemotherapy regimens and found enormous variations in cost. “As bad as it looked then,” Dr. Lyman commented in an interview, “I would guess it is even worse now.”

Cetuximab and bevacizumab may increase costs by as much as $10,000/month and only improve the outcome by a modest amount.

The larger question is whether physicians and institutions should factor in cost to the treatment equation. It’s been our practice to ignore cost when considering treatment alternatives but as the expenditures for health care increase exponentially it may be time to consider another approach.

It is difficult for individual physicians to do all the work on this. In UK there is an agency, the Nation Institute for Health and Clinical Excellence (NICE), that produces studies and make recommendations to their National Health Service. A similar non-biased source of cost/effectness evaluation in our system should be welcomed by all practitioners. For what it’s worth the FDA is prohibited from including cost in their evaluations of new drugs.

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The rosuvastatin (Crestor) Jupiter study–Watch your wallet

This week we were inundated with reports of a major study with near miraculous results. Just under 18,000 participants in the Jupiter study either received rosuvastatin (Crestor) or placebo. Patients were chosen to participate if they had low LDL cholesterol (under 130 mg/deciliter) and elevated C-reactive protein (above 2 mg/liter). The results, as summarized, in a accompanying editorial :

The trial of nearly 18,000 patients was stopped, with only 1.9 of its proposed 4 years of follow-up concluded, when the data and safety monitoring board noted a significant reduction in the primary end point among participants assigned to receive rosuvastatin (142 primary events, vs. 251 in the placebo group; hazard ratio, 0.56; 95% confidence interval [CI], 0.46 to 0.69). There was a similar reduction in a combination of the more important hard outcomes: myocardial infarction, stroke, or death from cardiovascular causes (83 events in the rosuvastatin group vs. 157 in the placebo group; hazard ratio, 0.53; 95% CI, 0.40 to 0.69).

The study also reported virtually no extra side effects among the study patients. “Total numbers of reported serious adverse events were similar in the rosuvastatin and placebo groups (1352 and 1377, respectively; P=0.60) Nineteen myopathic events were reported (in 10 subjects receiving rosuvastatin and 9 receiving placebo, P=0.82)” There was one case of major muscle lysis problems (rhabdomylysis) in a 90 year old man after the study was completed. Virtually all other toxicity was equivalent between drug and placebo.

Medicynical note: As noted above the finding that there was no difference in side-effects between the drug and placebo is at least a little strange. That the reported side effects occurred much less frequently even than the incidence in the FDA drug insert also is remarkable. It could indicate patient selection or bias from in this drug company sponsored trial. Interestingly 25% of patients were reported not taking the drug at the end of the study. Why? That’s left to the imagination.

From the drug insert:

In clinical studies of 10,275 patients, 3.7% were discontinued due to adverse experiences attributable to rosuvastatin. The most frequent adverse events thought to be related to rosuvastatin were myalgia, constipation, asthenia, abdominal pain, and nausea.”

Uncomplicated myalgia has been reported in rosuvastatin-treated patients (see Creatine kinase (CK) elevations (>10 times upper limit of normal) occurred in 0.2% to 0.4% of patients taking rosuvastatin at doses up to 40 mg in clinical studies. Treatment-related myopathy, defined as muscle aches or muscle weakness in conjunction with increases in CK values >10 times upper limit of normal, was reported in up to 0.1% of patients

The NEJM editorial about the study also noted:

On the other side of the balance, of concern are the significantly higher glycated hemoglobin levels and incidence of diabetes in the rosuvastatin group in JUPITER (3.0%, vs. 2.4% in the placebo group; P=0.01). There are also no data on the long-term safety of lowering LDL cholesterol to the level of 55 mg per deciliter (1.4 mmol per liter), as was attained with rosuvastatin in JUPITER, which is lower than in previously reported trials. Long-term safety is clearly important in considering committing low-risk subjects without clinical disease to 20 years or more of drug treatment.”

An additional concern is cost.

“The proportion of participants with hard cardiac events in JUPITER was reduced from 1.8% (157 of 8901 subjects) in the placebo group to 0.9% (83 of the 8901 subjects) in the rosuvastatin group; thus, 120 participants were treated for 1.9 (Medicynical note: 693 days) years to prevent one event.

At a cost of $3.45/day treating 120 patients for 693 days is a total of almost $300,000 spent to prevent one event. This is far above any reasonable cost/effective intervention. It’s obvious why this information was not included in this drug company sponsored study. It is, however, one of the major concerns we all should have in this time of crisis in health care.

Having patients commit to take a medication for the duration of their lives to prevent serious medical problems is the dream of drug companies. But in order to seriously consider such an intervention, it must be very effective, have low toxicity and be affordable both for the patient and the health care system. Use of rosuvastatin to prevent cardiovascular disease doesn’t fully meet these criteria and as such, the report should be viewed as an interesting approach that merits further study, not wholesale adoption.

In the press I noted comment that other statins that are available as generics may have the same beneficial effect at lower cost. It’s unlikely however, that drug company sponsored studies of these low cost alternatives will ever be done.

Quality of Chronic Care in the U.S. Non system of Healthcare

Health care in the U.S. is slowly crumbling. Everyone (except those who are exceptionally financially secure) is dissatisfied, including patients. This report of an article in Health Affairs sums up the patient’s views:

“Chronically ill Americans are more likely to forgo medical care because of high costs or experience medical errors than patients in other affluent countries”

“Fifty-four percent of Americans surveyed said high costs prevented them at some point from getting recommended medical care, filling prescriptions or seeing a doctor when ill. Seven percent of the Dutch cited cost as a barrier to treatment.”

“In addition, 41 percent of the U.S. patients said they spent more than $1,000 over the past year on out-of-pocket medical costs. That compared to lows of 4 percent in Britain and 5 percent in France.”

“In short, the U.S. patients are telling us about inefficient, unsafe and often wasteful care. The lack of access, combined with poorly coordinated care, is putting these patients at very high health risk and driving up costs of care.”

Those who defend our health care say “we have the best care in the world.” (attribute to Bush, McCain, Limbaugh and their ilk) They simply don’t operate in the real world.

We have an opportunity here, the question is whether we’ll be able to act on it.

A first step to health care for all–reforms that won’t cost a penny

Price competition is fundamental to the capitalist system. In a perfect world, competition leads to the right price for product and results in value to consumers. Such competition however is anathema to health care.

Why?

On one hand we have patent monopolies which allow patent holders to charge whatever they want for a product for a generation.

Second we find it difficult as a society, as health providers and as consumers to place a monetary value on health care, a surrogate for life itself.

Third, the system is full of conflicts of interests. Providers, patients and industry all have agendas. Patients want to live but don’t fully understand the nuances of the decision. Pricing information is hard to find. Industry’s interest is in profits not the best health care decision. Information on health care decisions is complex and guarded. As a result value in medicine is an oxymoron.

I’ve focused on cancer medicines in previous posts in part because pricing is extreme and also because patients with cancer perceive that they face the ultimate dilemma-pay or die. Cancer pharmaceutical pricing is indeed a death tax, a system that redistributes wealth rather than assures quality care at reasonable price.

The question is whether there is, or should be, a quid pro quo for a government granted pharmaceutical patent monopoly. One that will assure reasonable pricing. This article on Financing Drug Research offers some suggestions. Medicynic suggestions won’t cost a penny and are a good start to a new health care system:

1. Require the government and pharmaceutical companies to negotiate prices for patented medications purchased for government programs and beneficiaries. Including Medicaid, Medicare, the Federal Employee program and Tricare this would affect 100 million citizens (1/3 the population of the U.S.) Since we like transparency we should make the negotiated prices public.

2. Enforce the reasonably pricing provisions of Dole-Bayh. Retrieve the taxpayer’s contribution to drug development costs (approximately 20 billion a year to basic medical research) from patent holders and use these proceeds to defray pharmaceutical prices to consumers. This would also require the disclosure of the real development costs of pharmaceuticals.

3. Prohibit direct to consumer (DTC) advertising. In a 30 second ad full disclosure as outlined below is not possible. As a result patients do not fully understand the limits and costs of any given product. Few countries allow such advertising.

4. If we don’t wish to completely prohibit DTC advertising, require full disclosure. This would include mention of the risks of treatment and a summary of proven benefits and competing approaches in clear language that a lay person can understand. The price of the medication, with estimates of monthly and yearly costs as well as a measure of cost effectiveness (cost/unit of additional survival time or other approved measure) must be also be provided to fully inform the consumer.

5. Require clinical studies to include cost data as well as a measure of cost effectiveness (QALY-Quality adjusted life year or other) in the discussion of any phase II, III or IV study reporting positive results.

6. Monitor the FDA approval process to be certain that generics come to market quickly on patent expiration.

7. The Canadian system controls patented drug prices by not allowing marketing unless the drug is priced right. A similar program could be instituted here to decrease our pricing to the level of other industrialized countries.

8. Alternatively, link the length of patents to reasonable pricing. As part of the FDA approval process the proposed price of the new medication would be compared with similar medications already on the market and with the same medication in other countries. The same process that the Canadian patent drug review board uses. If priced a significant amount over the comparator, the patent length would be decreased by some period of time to be determined by the review process–there are many ways such a link could be structured. For unique innovative drugs the cost of development could also be factored into the pricing length of patent equation. Price increases during the duration of the patent would be tied to the rate of inflation. If they exceed that rate the patent length would be proportionally shortened.

Stiglitz on the economy (and healthcare)

Washington Post has an op ed by Joseph Siglitz on the Obama’s economic challenges:

“Obama will also need to deal with some vast inefficiencies in our economy if we are to prevent further erosions in our standard of living. Some U.S. sectors are global leaders, such as our world-beating universities and the high-tech firms that thrive on the ideas hatched in our ivory towers. Others are embarrassing, such as health care, where Americans spend far more than citizens in many other industrialized countries and get underwhelming results. We need a bold approach here, reforming not just the way we provide medicine but also thinking more broadly about health. That means doing more about diseases associated with alcohol, drugs, tobacco and obesity, which have increasingly come to symbolize American over-consumption.”

Medicynic believes our system of healthcare has evolved to not contemplate value when considering treatment alternatives. Inefficiency is integrated into every level of our non system. In research the emphasis is developing patentable advances so as to develop new approaches that a company can monopolize for a generation. Despite laws that mandate reasonable pricing our new advances are priced to assure huge company profits rather than assure patients access. The U.S. private care system spends 30% of health expenditures on administrative overhead compared with 5-10% spent by Medicare. (Canada 17%, UK 12 %, France 10%) Suppliers and providers operate in a cost plus environment without any incentive to be efficient. Pharmaceutical manufacturers spend more on marketing than research and pass the costs along to all of us. They obfuscate mediocrity in order to maximize their bottom line rather than showing interest in patient well being or for for that matter the survivability of our health care system. Hospitals view healthcare in terms of product lines and profit margins rather than benefits to patients. Physicians almost never consider cost/efficacy when recommending interventions. How else to explain the popularity of use of expensive ($100,000 plus/year) interventions that have shown minimal effect on longevity.

As noted by Stiglitz notes we pay more and get less out of our healthcare than most other industrialized countries. Hopefully CHANGE is coming!

Stupidism, the other S word

I am having difficulty with the current presidential campaign understanding how our political system reveres the stupid.

It’s simply stupid to believe that Palin is the “best” candidate the republican party could find for Vice President. She’s clueless, and unqualified. Her lack of qualification is manifest in her intellectual achievements (see her academic record, also review McCain’s); lack of national experience and basic knowledge of the world; skepticism regarding science and scientific method; performance in interviews after her selection; and in her loudly stated view that a African American son of a single mother who through the strength of his intellect became a highly respected lawyer and community organizer is one of the “elite.” It’s as if being smart is a problem. She simply makes no sense. Yet she is the best the republican party can do. Her choice and views are prime manifestations of stupidism in this campaign.

The presidential candidate for that party has proposed an elaborate shell game that is his health care policy. It will eliminate health insurance as we know it and move most of us to the expensive individual health insurance market. Many will not be accepted for insurance or charged outrageous premiums because of all things they are sick and need their health insurance. Nothing like a policy that works to eliminate coverage for those who need it most.

In regard to healthcare the question is who is more stupid. Those who propose a flawed bizarre policy or those who will seek temporary personal advantage in such a policy–by not having coverage or by buying cheap policies that don’t provide comprehensive coverage. I say temporary because we all will have illness at some point. When that happens these guys will have inadequate or no coverage and be unable to afford their treatment. At that point they may try and upgrade their health insurance policy and as noted above will be flushed out of the private insurance system. Not understanding the implications of segregating risk in health insurance and voting for a candidate who proposes such a policy is also a manifestation of stupidism.

With the economy tanking, the repubicans sell the notion that up is down and down is up. McCain a long term and recent proponent of deregulation now claims he has always been for regulation of financial markets; Palin wonders how a Democrat can propose cutting the military budget in a time or war, while McCain has stated he knows of waste and mismanagement at the Pentagon and can easily cut their budget. For these people, support of a stupid war is patriotic but paying for it with taxes isn’t. What isn’t stupid about this campaign?

Consider this election a ballot initiative on stupidism.

Placebos, Much ado about nothing, literally

For years we’ve been hearing of the “benefits” of such interventions as homeopathy, mega-vitamin therapy, coffee enemas, detoxification, cranial sacral therapy, weekly chiropractic therapy and a multitude of other alternative remedies.  People swear they help and spend billions.   Yet there is precious little evidence that show’s benefit such as decreased chronic illnesses or improved longevity.

So it’s not surprising that a study of routine medical practices reveals that doctors candidly believe some of the practices no better than placebo.  I used to tell patients with colds that without treatment it would take seven long days for the problem to resolve.  With antibiotics it would take just one week–yet that is what they wanted.  I was told that if I didn’t treat them they’d find someone else to do so and a number of patients did so.

It’s as simple as that, people believe an intervention anyone, even lacking in evidence, is better for them than none.  How else to explain the “efficacy” of homeopathic remedies which contain no active ingredient and is diluted to the the point of having no medicinal value.  Yet patients swear by it because they think they are being treated and they do get better.  It should be pointed out that the great majority of what a family doc sees each day would also better, just as quickly and completely, without any intervention.  Patients seek  reassurance but also in many cases insist on something being “done.”

That’s the essence of placebos and as long as patients want to believe it works it will in most instances–just a week rather than 7 long days.

But it is a costly game.

Taxing Benefits vs a Salary Cut–McCain’s Hobson’s Choice

If McCain is elected and implements his health program you can say good bye to employer based health coverage and expect a salary cut.

The McCain health plan proposes to tax health benefits provided by employers as ordinary income.  If the employer stops providing health benefits (worth up to $12,000 or more) then there will be a tax credit offered of $5000/couple ($2500/person) to buy insurance in the open market.

You have to watch your wallet here.  By slight of hand the plan takes an up to $12,000 insurance benefit that comes with employment and throws you into a treacherous individual insurance market with $5000.  If you or a family member have a serious illness under McCain’s “plan” you will be charged more or even denied coverage.  If you are healthy you may be offered a variety of products many of which provide inadequate coverage that you only discover is inadequate after you become sick.  You will be rated each year and there is no guarantee of continued insurance coverage at any price if you are in great need.  Quite a program for insurers.

Adding insult to injury, you remember your health benefit that was being taxed as your ordinary income?  It was worth up to $12,000.  Guess whose money that is?  It was to be taxed as your income but as soon as the employer dropped coverage, your income became the employer’s revenue.  In other settings that’s what’s known as a salary cut.  It’s almost as obtuse and ingenious as leveraging mortgages or credit default swaps.

I should disclose that while I don’t particularly care for employer provided coverage, the McCain program would be an abomination.

The Four topics rarely discussed at medical meetings

1. Cost/Efficacy–Is the response to treatment worth the cost.  At most meetings cost is never mentioned when discussing results.  This in  an era of $100,000 medications and health cost inflation.

2.  Value–Presentations at meetings are geared to show off new medications.  At time the educational programs will objectively review the field and make unbiased suggestions but for the most part the programs are funded by the industry and the speakers are on the payroll.  As a result evaluations of alternative treatment and of course considerations of cost/efficacy are rarely heard.

2. Patent reform–Meetings are for the most part sponsored by drug companies (patent holders), enough said.

3. Conflicts of interest–It’s not unusual to have speakers touting results of studies who are on the payroll of the drug company that makes the product being tested.  Disclosure is not enough!

Ten Issues that go away with a Universal Health Insurance and two that won’t

Ten issues that go away with a national health insurance system:

1. The approximately 47,000,000 uninsured: All will have access to coverage with incentives for provider efficiency and the most cost efficient interventions.

2. The profit squeeze on employers who provide health insurance to employees: It’s estimated that U.S. car makers have expenses of over $1500/car related to health care coverage for employees. A national system, delinked from employer based insurance, allows our employers to compete on the same basis as those in other industrialized countries.

3. Our disgraceful system of health care for GI’s and their families: Incorporating the VA and military health care systems is into a National Health Insurance program provides more and better options for care. These will be community based and thus provide more convenient access.

4. The administrative duplication and fraudulent behavior of multiple insurance providers, each with their own administrative overhead and fiduciary responsibility to generate profits: It’s estimated that we spend 30% of our expenditures for health on administration ($1059/capita in U.S. vs $307/capita in Canada). That could easily be halved or more with a national health program.

5. The conflict of interest between insurers, providers and patients.

6. The crisis in emergency rooms: With insurance people will have a place, other than ER’s, to go with non-emergent medical issues

7. The dance of the veils billing system: There is no set price for services. Those with leverage, i.e. large insurers, are given large discounts while the individual pays the full amount. If everyone has insurance there will be one negotiated price.

8. Big PHARMA’s free ride: We pay more for medications than any other industrialized country. PHARMA’s mantra that they need profits to encourage creativity is bogus when one considers they spend more on promotion and advertising than research. In a national insurance scheme drug price negotiation will be the rule–as it is in the rest of the industrialized world. (see more below)

9. Bankruptcy due to enormous medical bills

10. Our mediocre health care outcomes: We spend more per capita than anyone, yet our outcomes are in the middle of the pack. With universal access we can expect this to change.

None of this will be automatic and actually having an efficient functioning system of care will require much due diligence and negotiation.

What won’t change is physician unhappiness with reimbursements and the continuing issues with intellectual property rights. No where in the world are physicians as well paid as here. We’ve made the profession entrepreneurial and money driven and in the current non-system reward procedures rather than primary care. It can be anticipated that a national health insurance scheme will want to flatten the disparities and redistribute, somewhat, the fees. One would hope this would guarantee all physicians reasonable reimbursement for their time and expenses. However, meeting the expectations of the profession will be almost impossible–as it is now.

We do need some type of protection for innovators in our system. We should not however delude ourselves that this is a “free market”. Patent protection creates monopoly and in health care that has resulted in a life threatening market distortion that we can no longer afford. We need to somehow require patent holders to price their products responsibly and to be efficient in their product development and marketing. Once again meeting the expectations of the industry and their stockholders will be almost impossible–as it is now.

But in both cases the status quo is not working.