Medicynic

The zoledronic acid (Zolmeta) study reported:

“The women were premenopausal and were receiving hormone therapy – either tamoxifen or anastrozole – to prevent recurrence of their tumors. Half the women also received Zometa.”

It should be emphasized that this study was in pre-menopausal women. The results do not necessarily apply to older women–in whom 75% of breast cancers occur.

The ASCO abstract of the study stated:

“With median follow-up of 60 mo (March 31, 2008), 137 (7.6%) DFS events and 42 (2.3%) deaths have occurred. There was no significant difference in DFS between patients who received TAM alone vs ANA alone (HR = 1.10 [95% CI = 0.79, 1.54]; P = 0.59). However, endocrine therapy plus ZOL significantly reduced the risk of DFS events by 36% “

Lets look at that 36% figure. The difference (reported in news articles) between the the two groups was that 9% of those receiving hormone therapy alone recurred while 6% recurred when zoledronic acid was added. This is in absolute numbers a 3% difference between treated and untreated–and could be due to a small difference in disease severity between the groups or actual benefit from the drug. In any case the people promoting this study at some point decided that a 3% benefit doesn’t sound impressive enough so the investigators call it a 35% reduction of risk (9% to 6%). While technically right in their claim, it, in reality, is just a 3% absolute decrease in recurrence in the study group.

Looked at another way 91% of those treated with hormone blockers and 94% of those with the added zoledronic acid were disease free at the end of the study–even less impressive.

As a matter of fact after 5 years one cannot be sure whether patients will recur later and even out the recurrence rate. The delay in recurrence is a real benefit particularly if it is associated with a survival benefit–which has not yet been proven with this drug. So more time will need to pass to fully understand the benefits of this intervention.

In media reports there were no analyses of cost implications of the use of this drug.

The cost of zoledronic acid is about $2000/year, not a huge number but consider, in order to get the 3% improvement, you need to treat all the patients diagnosed with breast cancer receiving hormonal blocker adjuvant therapy. That means the costs for zoledronic acid in 100 cases will be $200,000 or about $66,000 for each of the 3 patients in 100 who benefit from the drug treatment.

For the health care system (and the pharmaceutical manufacturer) the financial aspects may be profound–particularly if the results are extended to post menopausal patients. There are about 185,000 new cases of breast cancer/year. If you figure that 100,000 patients require adjuvant therapy (therapy to prevent recurrence after surgery) that means a cost to the system of $200 million dollars/year to delay recurrence (some of these may be cures) in 3000 women. These costs are in addition to the cost of surgery, physicians, hormone blocker costs etc.

More study necessary? Of course. Cost effective? It’s anybody’s guess. Shouldn’t cost data be a part of the analysis of new interventions? I can’t think of a reason to not have such analysis.

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This report from ASCO today illustrates the cancer PR train at full speed.

It reports that “The drug Erbitux lengthened the survival of patients with advanced lung cancer by about five weeks “(11.3 months survival vs 10.9 months) What’s not noted in the article is that this drug costs in the range of $10,000/month. Nowhere in the discussion is the question raised whether the drug is cost effective. What’s emphasized is that the drug is a step forward because there is a survival benefit–albeit very very short!

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This is the week of the American Society of Clinical Oncology’s (ASCO) annual meeting. Drug companies will roll out PR blitzes for drugs showing any hint of anticancer activity.

You can expect lots of data showing improvement quoted as percent improvement rather than actual numbers. For example, if you have 3 chances in 100 of cancer recurring and the drug decreases the risk to 2 chances in 100, guess how the authors and drug companies will tout the data? Instead of saying it will decrease your chance of recurrence by 3 cases/100 to 2 cases/100, we will hear about a 33% decrease in the risk of cancer recurrence.

Also missing will be cost data. In a “consumer driven” health care system with drugs often costing over $50,000/year for the drug alone (more than the average and mean salaries/year in our country) revealing the cost is as important as honestly representing results.

Expect both to be obfuscated this week.

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Interesting series of articles in the Washington Post reporting on the quality of health care provided and misuse of medications in our facilities for “war on terror” detainees.

“The Washington Post has identified in which the government has, without medical reason, given drugs meant to treat serious psychiatric disorders to people it has shipped out of the United States since 2003”

“Involuntary chemical restraint of detainees, unless there is a medical justification, is a violation of some international human rights codes. The practice is banned by several countries where, confidential documents make clear, U.S. escorts have been unable to inject deportees with extra doses of drugs during layovers en route to faraway places.”

This is from the Wikipedia version of the classical Hippocratic oath:

“I will apply dietetic measures for the benefit of the sick according to my ability and judgment; I will keep them from harm and injustice.”

This report illuminates the tip of an embarrassing iceberg. Physicians working at Guantanamo, places like Abu Graib and such also have questions to answer. Are medical ethics quaint relics of a time gone by?

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The question I have when reading a journal or listening to a report in the media about drug efficacy, medical procedures, or other new technology is whether there is a financial relationship between the author(s) and the company behind the medical advance under evaluation.

In medical journals there is often a vague statement acknowledging financial arrangements. In other media there is almost never mention of such affiliation. In both cases I’m left to wonder whether I should discount the results because of conflicts of interest.

Slate magazine has a interesting take on the lack of such disclosure on public radio (commercial radio has similar issues).

It would be much simpler if those evaluating the efficacy of new medical products did not have such financial relationships. It’s unlikely however that such arrangements would be banned in our “free” and open society. As an alternative I would suggest full disclosure.. This would include the company involved, the amount of money provided and the specific information about extent of involvement of the donor or donor’s employees in the study’s design, analysis and publication. This information should not be buried at the end of the article/presentation but be featured prominently up front, along with the title and authors.

Transparency will help but the admission of a potential conflict of interest still leaves me with the dilemma of whether or not to believe the finding.

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Anti-inflammatory drugs don’t prevent Alzheimer’s. It’s hard to believe we thought this was likely. It appears to have been based on this:

“Scientists have speculated (our emphasis) that non steroidal anti-inflammatories, such as Aleve and Celebrex, might prevent Alzheimer’s by reducing inflammation in the brain or by other means.”

Statins don’t help Alzheimer’s either.

“‘In a study in patients with mild-to-moderate Alzheimer’s disease (AD), the addition of Lipitor (atorvastatin calcium tablets) 80 mg to Aricept(R)(donepezil HCl) 10 mg showed no significant differences in cognition or global function (key measures of Alzheimer’s progression) compared to placebo plus Aricept 10 mg.Lipitor,'”

Nor will Vitamin E prevent cataracts. This was a large double blind study with “37,675 women without an initial diagnosis of cataracts. Half took 600 international units of vitamin E on alternate days; the rest took a placebo.”

“there was no difference in the number of cataracts between the groups and no difference in the types of cataracts they developed. Nor did those with possible risk factors like age and cigarette smoking get any benefit from vitamin E.”

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Our non-system of health care is imploding. Even the insured can’t afford it.

As noted previously, we have a regressive health care death tax that has no limitations based on net worth or income. It’s a tax on life.

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There is something terribly wrong with our costs. Inefficiency in health care is bankrupting us. In the rest of the industrialized world costs are intermediate between those cited below and ours,  but still in the range of 50% less. Somehow our system of patents, income expectations, inefficiency at every level, unrealistic patient expectations and a system based on reimbursing costs, no matter outrageous, has had a terrible effect.

Medical tourism – surgery cost estimates

Source: Medical Tourism Association (2007).

None of our presidential candidates seems willing to address these underlying issues.

McCain’s “free market” solution is similar to Marie Antoinette’s let them eat cake. It provides tax rebates that don’t cover the cost of insurance and leaves all the inefficiencies, expectations and costs intact. His plan creates a system where it’s legal for insurers to raise rates and deny coverage to those who actually need health care. The insurer’s skim profits off of the healthy and then cost shift the burden to government when the person becomes sick. This is a money making scheme for the insurance industry not protection for consumers.

The health insurance fixes of Obama and Clinton are also inadequate but not quite as cynically structured. They simply don’t solve the problem by leaving the cost structure and expectations of both health suppliers and consumers intact.

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“Sixty-seven randomized trials with 232,550 participants were included. Forty-seven trials including 180,938 participants had low risk of bias. Twenty-one trials included 164,439 healthy participants. Forty-six trials included 68111 participants with various diseases (gastrointestinal, cardiovascular, neurological, ocular, dermatological, rheumatoid, renal, endocrinological, or unspecified). Overall, the antioxidant supplements had no significant effect on mortality in a random-effects meta-analysis (relative risk [RR] 1.02, 95% confidence interval [CI] 0.99 to 1.06), but significantly increased mortality in a fixed-effect model (RR 1.04, 95% CI 1.02 to 1.06).”

“We found no evidence to support antioxidant supplements for primary or secondary prevention. Vitamin A, beta-carotene, and vitamin E may increase mortality. Future randomized trials could evaluate the potential effects of vitamin C and selenium for primary and secondary prevention. Such trials should be closely monitored for potential harmful effects. Antioxidant supplements need to be considered medicinal products and should undergo sufficient evaluation before marketing.”

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Senator McCain publicized his plan for health care (more here). It has so many flaws it’s amazing he brings the subject up.

1. Moving from employer based insurance will provide an incentive for employers to not provide insurance. The employer gets to pocket some or all of what he currently pays for employee insurance–it may be too tempting to pass up.

2. The tax rebate for health insurance will not cover the cost of insurance. As a result there will be an increase in the uninsured in this plan.

“The plan calls for giving $2,500 tax credits to individuals and $5,000 credits to families to buy insurance.”

“The average cost of an employer-funded insurance plan is $12,106 for a family, according to the Kaiser Family Foundation, a health policy group.”

3. It’s a time-honored tradition in the health insurance business to flush the sick out of the private insurance system. A health insurance crisis in the 60’s brought about coverage for the elderly. McCain’s plan encourages insurers to do just that by increasing competition for the healthy and charge more or reject those with medical problems. This may increase the uninsured and the burden on Medicare, Medicaid, and charitable medical care. Quite a plan!

4. Our health costs are higher in many cases by 100% than other industrialized countries in part because of insurer’s administrative duplication. McCain’s plan does nothing to address this problem and may make it worse.

5. Our costs for technology–drugs, imaging, etc– are significantly higher than anyplace else in the world. The plan does nothing to address this. McCain maintains it will open health care to competition but unless something is done about patent monopoly abuse there will be no improvement.

A plan to provide care for the healthy does not solve our health care access and quality problem.

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