April 26, 2008
TORCH Analysis
American Family Physician (paid subscribers only) has a great analysis of the TORCH study. TORCH (Toward a Revolution in COPD Health) was a large, randomized, double-blind trial studying a treatment for COPD (emphysema). The particular treatment they were studying has great theory behind it, but came under question a few years ago for increasing deaths in kids treated for asthma with the combination.
What Mark Graber points out in this Journal Club format is that not only is the mortality not affected by these drugs alone or in combination, but the benefits touted for the drug are not very meaningful. The NNT (Number Needed to Treat) to prevent an exacerbation of COPD is 4, which is good. But the NNT for one year to prevent a hospitalization is 33. That means that 33 patients have to be treated with this medicine to even keep one out of the hospital. That is of arguable meaningfulness.
Where the study is deceptive is in downplaying the increase in cases of pneumonia. The NNH (number need to harm) for one year for pneumonia is 41. If 41 people are treated for one year, there will be one additional case of pneumonia in the combination treatment group. These did not translate to deaths, apparently. But certainly the benefit is offset by the harm.
The Journal Club also points out that there were a lot of dropouts from the study, and all the drugs were made by the drug company sponsoring the study, with no comparison with other helpful treatments in COPD.
It is refreshing to see an increase in such analyses.
Clinical Iatrogenesis | By Robert Maddox | 09:24 PM | Comments (0)
April 07, 2008
ADVANCE ACCORD
This editorial evaluates the differences in conclusions between ACCORD (which showed that the group with the lower risk of death from heart attacks was the group that had the less-intensive glycemic-lowering target) and ADVANCE [Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation] (which preliminary results without release of mortality data indicates the opposite).
What is most interesting to me about this analysis is that Dr. Hellman identifies two factors that might explain the differences between the studies. Both are patient characteristics: the ability to detect one's own low blood sugar, and the decreased mental acuity or cognitive function of advanced diabetics.
This is a novelty: a recognition that real patients with real and multiple problems don't fit our neat study categories. Sure, maybe it is true that intensive therapy for diabetics save lives, if the study is done under controlled other-worldly conditions. But in real patients with difficult lives, intensive therapy kills.
Dr. Hellman calls for individualizing therapy. This is certainly important. Knowing the patient, loving the patient and caring for the patient are essential. And then, the A1c isn't so important.
| By Robert Maddox | 06:05 PM | Comments (0)
Who should pay?
From the same issue, a graph of a 2007 survey of 3,501 adults asking, Who should pay for Americans' Health Insurance?
Only 6% responded "mostly individuals." The rest responded that some combination of employers, government, and/or individuals should share costs.
This undoubtedly is how people feel about that most precious and essential to life commodity, food. It seems just as reasonable to demand that others pay for my food, while allowing me my choice in culinary delights. If my tastes happen to be more expensive than the average, so be it. And of course, only those foods deemed healthy by the experts will be paid for. The reality that these experts can't agree on what is healthy food should not deter us. Whoever is in power has the divine right and responsibility to make those choices.
So in the upcoming election, maybe you should be asking what Hillary, Obama and McCain like to eat.
| By Robert Maddox | 04:56 PM | Comments (0)
Trading measles for seizures
After yet another long lapse, I post. As I am my primary audience, this does not bother me. I know how much reading and studying I do, how many patients are cared for in the intervening days and weeks. If you object, let me know.
An article in Family Practice News summarizes data from the KP Vaccine Study Center's Dr. Klein, whose analysis of the Vaccine Safety Datalink data for that week in February showed an increase in post vaccination seizures for MMRV (the combination of MMR with Varicella -chickenpox). There were 5 additional seizures for every 10,000 children who received the MMRV instead of the separate vaccines.
So how many seizures were there after the separate vaccines? Well, depends on how many days post vaccination and which vaccines you are asking about. The biggest cluster is at 7 -10 days post vaccination, with 9.6 for MMRV, 4.9 for MMR plus a separate V, 3.5 for MMR alone, and 1.5 for varicella alone. But the "expected number of seizures total after MMRV is 14.7/10,000 or 1/680. The increase that caught their attention was to 1/440 or 22.7/10,000.
The discussion is on whether administering these vaccines together is worth this possible extra risk.
But based on my previous discussions of vaccine efficacy, my question is whether they are worth it at all. Remember that these diseases are very rarely fatal. The vaccines are sold on the promise of peace of mind. But if one in 500 will have a seizure, up to 42 days after administration, how peaceful will the parents' minds be?
Clinical Iatrogenesis | By Robert Maddox | 04:46 PM | Comments (0)
March 05, 2008
vaccination pain overload
A new study released in Pediatrics compared a sucrose solution to water placebo as anesthesia two minutes prior to the routine 2 and 4 month immunizations. Responses were measured on a pain scale at 2, 5, 7, and 9 minutes. There was a 78% (relative) reduction in mean pain score for the sugar group. (The absolute reduction was approaching 3 points on their pain scale.)
I am not sure of the pain scale used, or how accurate it is. But this seems to be a clear case of data overload. Besides the confusion of using the term "anesthesia" for this response to sugar, there is the issue of whether water is an adequate placebo. What baby wouldn't cry if given water instead of sugar?
But knowing this much information about the (presumed) pain response of infants after immunizations (and they received DTaP, IPV, Hep B and Hib over the several minutes) assumes that the vaccines are worth it, an assumption that has been significantly challenged, both on these pages and elsewhere. But even assuming they are worth it, does it really help us to have this much information about the relatively minor pain of what the advocates consider to be worth any risk or cost? Couldn't any grandmother have told us that an infant is happier with a sugar tit? Is this not yet another attempt to shepherd the wind?
Social iatrogenesis | By Robert Maddox | 01:10 PM | Comments (0)
February 21, 2008
More Statin controversy
I have never followed the business news but this commentary from AAPS gives some hope. The business and even news people are beginning to understand the difference between relative and absolute risk reduction.
The question still remains: is an absolute risk reduction of 1% (which I would challenge) worth the risk of the medicines?
But the bigger question is not even asked: Is an attempt to reduce this one risk by this 1%, in light of the thousands of other risks we daily face, tantamount to idolatry?
| By Robert Maddox | 02:03 PM | Comments (2)