Monthly Archives: June 2008

I came across a letter in the June 26th N.Y. Review of Books from Gayle Greene regarding a dispute in the 50’s and 60’s about the safety of x-raying pregnant mothers. Today a defense of this practice would be viewed as ludicrous but read the letter, and also the book The Woman Who Knew Too Much: Alice Stewart and the Secrets of Radiation to learn more.

From the NY Review of Books:

“I interviewed Doll while writing about Stewart, the physician and epidemiologist who discovered that the practice of X-raying pregnant women, which was common in the Forties and Fifties, doubled the chance of a childhood cancer. Doll and Stewart moved in the same Oxbridge circles, sat on the same committees and editorial boards. Both started out as physicians, then moved into epidemiology after the war, each making major discoveries in the Fifties that helped shape epidemiology so it came to include cancer as well as infectious diseases. But after Stewart went public with the dangers of radiation, she plummeted to obscurity, while Doll, credited with discovering the link between lung cancer and smoking, rocketed to fame and a knighthood.”

“Immediately after Stewart published her findings, Doll launched a study to prove her wrong. For nearly two decades, he succeeded in keeping her findings from being accepted, thereby allowing fetal X-raying to continue”

“After his death it came out that Doll was receiving payment from Monsanto (quite a lot) all the while he was doing the studies that cleared vinyl chloride of an association with liver cancer. I’d have thought that would have laid to rest this overblown veneration. But no, Horton defends him, suggesting that he may simply have been “naive.” I can tell you, whatever else he was, he was not naive.”

Not much has changed as indicated in today’s (June 8,2008) NY Times report on professors of pediatrics receiving unreported income from drug companies.

“In 2000, for instance, Dr. Biederman received a grant from the National Institutes of Health to study in children Strattera, an Eli Lilly drug for attention deficit disorder. Dr. Biederman reported to Harvard that he received less than $10,000 from Lilly that year, but the company told Mr. Grassley that it paid Dr. Biederman more than $14,000 in 2000, Mr. Grassley’s letter stated.”

“At the time, Harvard forbade professors from conducting clinical trials if they received payments over $10,000 from the company whose product was being studied, and federal rules required such conflicts to be managed.”

This is the tip of the iceberg of unreported relationships between physicians, researchers, and institutions and the medical industrial complex.

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Medicare drug costs, deductibles (read that as the infamous doughnut holes) are increasing at multiples of the inflation rate and the insurance for Medicare part D are increasing at multiples of the inflation rate.

In the political campaign we talk of strategies to provide universal health care but have heard few if any suggestions to control costs. We continue to pay whatever the providers charge (providers=practitioners, institutions, insurers, equipment manufacturers and pharmaceutical manufacturers). Where cost containment implemented it is almost always at the patient/practitioner/institution level.

That’s not bad but it has proven ineffective. We continue to have hospitals with wide variability of costs between one location and another; physicians overusing technology–doing tests and providing treatments that do not change decisions or outcomes; and pharmaceuticals that alone cost more than the average and mean incomes/year of individuals.

This is a system from hell and unless we are willing to attack costs beyond cutting provider reimbursement we will continue to pay twice what the rest of the world pay for care and continue to have mediocre results.

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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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