nos-trum. pronunciation: \nos'-trum\. noun. Etymology: Latin, neuter of noster our, ours.
1. a medicine of secret composition recommended by its preparer but usually without scientific proof of its effectiveness.
2. a usually questionable remedy or scheme.
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Monday, June 22, 2009

FDA, COOKIE DOUGH, TEEN BIRTHS, TELEHEALTH, AND CHILD DIABETES--A REAL MISHMASH OF STUFF

Things have been very dull for the last few months.  All the news is centered on healthcare reform.  There’s no solution to the cost problem, and I’ve pestered you all enough on that over the last nine months.  A Washington Post article (if you believe in bias, the Post is usually thought to be on the Left) sums up the problems very succinctly.  You can find it here: http://www.washingtonpost.com/wp-dyn/content/article/2009/06/21/AR2009062101789_pf.html.

 

It’s also taking longer for the fire of outrageousness to stoke my indignation.  When everything’s outrageous, nothing is.

 

For those of you who would like to hear about something else, here are a couple of things:

 

Experts call for sweeping health system changes to help treat, end symptoms of type 2 diabetes in children.

USA Today (6/22, Marcus) reports, "An increasing number of children are being diagnosed with type 2 diabetes, a condition medical experts blame on a culture steeped in junk food and inactivity that has led to more obese kids." According to experts, "aggressive early treatment and lifestyle changes can help, and even snuff out disease symptoms, but more sweeping healthcare system changes, including better health insurance for older teens and people in their 20s, are required for young diabetics to age into healthy older adults." Melinda Sothern, professor of public health at Louisiana State University Health Sciences Center, notes that "We have a new generation of children who are metabolically different. We think there's been a series of genetic mutations...over the last few generations that have led to this."

 

Doc D:  Genetic mutations?  There’s not a shred of evidence that I’m aware of to suggest this.  Some people get type 2 diabetes and are not fat, but we know that a good way to make even more people type 2 diabetics is to let them pork out and live on the couch.  We probably had less type 2 diabetes in kids decades ago because, to have fun, you had to go out and play.  And remember when school included PE?

 

Another in a long list of “call to arms”.  This one ranks about 267th in my top 1000 list.

 

Nestle recalls cookie dough rolls after E. coli outbreak.

ABC World News (6/21, story 6, 2:05, Muir) reported, "At least 65 people nationwide have been sickened by [a] dangerous strain of E. coli, including 25 who were hospitalized," presumably after eating Toll House cookie dough. The outbreak prompted Nestle executives to voluntarily "recall packages of" its refrigerated rolls. But, "how the bacteria, which is usually carried in animal feces, might have gotten into the cookie dough is a mystery."

 

Doc D:  No mystery.  Raise your hand if you think the food industry doesn’t add animal fat to its products.  Cookies are actually pretty fattening (54 cal out of the 130 per serving, most are worse), and that doesn’t come from the sugar.  On the other hand we’re talking about 65 people here so far.  I read in another article that they are mostly under 18.  It’s too few to generalize, but what are the odds that in some cases, people are eating the raw dough…didn’t you lick the mixing bowl when you were a kid?  We’ll see how this unfolds:  a small outbreak, or the beginning of the tide.

 

Rise in teen births may be spurred by decrease in contraceptive use, data indicate.

In The Checkup blog, hosted by the Washington Post (6/18), Rob Stein wrote, "The recent increase in teen births appears to be primarily the result of a decrease in contraceptive use, especially condoms," and not "a rise in sexual activity,"  according to a paper in the Journal of Adolescent Health

 

Doc D:  This is like saying that “Data indicate it was light out today because the sun came up.”  What incentive has there been to reduce sexual activity?  Thanks, Journal of Adolescent Health, for a dumb study.

 

FDA delays review of arthritis drug candidate.

The AP (6/18) reports, "Auxilium Pharmaceuticals Inc. on Thursday reported a delay in the Food and Drug Administration review of its arthritis drug candidate Xiaflex [clostridial collagenase]." On Sept. 16, the FDA's "Arthritis Advisory Committee will discuss Xiaflex," though the "FDA had been scheduled to make a full ruling on Xiaflex by Aug. 28, but Auxilium said a panel meeting could not be set before that date due to administrative issues."

 

Doc D:  The drug itself is not what concerns me here, it’s that the FDA is caught between a rock and a hard place.  If they take sufficient time to find out if a drug is safe (this sometimes takes 10-15 years), they are criticized for dragging their feet.  If they rush through something that could improve life-and-death situations, and someone gets hurt, they are criticized for doing a sloppy job.  I remember a few years back when the FDA announced the approval of a long-awaited beta blocker (a cardiac and BP type drug), saying that its use would save 14,000 lives a year.  Nobody stood up and said, “Does that mean that 14,000 people died every year it took to get this approved?”

 

Research suggests telehealth interventions may help cardiac patients improve their heart health.

In the Los Angeles Times (6/17) Booster Shots blog, Shara Yurkiewicz wrote that "electronic communication with a healthcare provider could have similar life-saving effects to the more traditional in-person cardiac rehabilitation programs," according to a study published in the June issue of the European Journal of Cardiovascular Prevention & Rehabilitation.

        HealthDay (6/17, Preidt) reported that investigators "reviewed published randomized trials evaluating the use of phone- or Internet-based interventions in cardiac rehabilitation programs. Two of the interventions were Internet-based; all others were by telephone."

        Healthcare IT News (6/17, Monegain) reported that the researchers found that "the telehealth interventions were associated with a 30 percent lower mortality rate than non-intervention controls, but this was not statistically significant and reflected a real-life 'absolute' risk reduction of one percent."

 

Doc D:  Results of this type of intervention are rarely sustained.  Admit it, we’re mostly slugs who only do what we have to.  I looked up the paper and you can read the abstract here:  http://www.ejcpr.com/pt/re/ejcpr/abstract.00149831-900000000-99916.htm;jsessionid=K1lcBB4F5wg1HVvGSRJfy4y1Z9G9HJzvmy7TjkR72G1SvgTps28y!-631714950!181195629!8091!-1.  Don’t bother.  The follow-up they made was “medium long-term” whatever that means—6 months or 6 years?  In any case, if you wait long enough, follow-up usually shows that people went back to their pre-study state.  Any initial improvement is due to the Hawthorne Effect, a well-described principle in science:  people do better for a while just because somebody is paying attention to them (see Wikipedia here:  http://en.wikipedia.org/wiki/Hawthorne_effect.)

 

And SECONDLY, the results were not statistically significant.  Read it again…did you miss that?  The article blows on by that to say there was a “real-life ‘absolute’ risk reduction of one percent.”  One WHOLE percent!  Call out the National Guard.  (no…wait…not statistically significant…forget it.)

 

 

Medical quote of the Day

Why does man like to be made sad when viewing doleful and tragical scenes, which yet he himself would by no means suffer?  And yet he wishes, as a spectator, to experience from them a sense of grief, and in this very grief his pleasure consists. What is this but wretched insanity?...Howsoever, when he suffers it in his own person, it is the custom to style it “misery;” but when he feels pity for others, then it is styled “mercy.”  --St Augustine, [354-430]

Nature Note:   The FDA is warning consumers to stop using and discard three zinc-containing nasal products: Zicam Cold Remedy Nasal Gel (a spray), Zicam Cold Remedy Swabs, and Zicam Cold Remedy Swabs, Kids Size. Since 1999, the agency has received more than than 130 reports of loss of sense of smell and/or taste associated with these products. A recent FDA inspection discovered that the company had received more than 800 other complaints that it did not send to the FDA. Many of the victims reported that their problem occurred with the first dose. (reported by Quackwatch, June 18)

Doc D:  the company who markets this stuff, Matrixx Initiatives, settled a class action suit in 2006 for $12M, brought by patients for the same problem.  But the company kept selling it.  The company labels this a “homeopathic” remedy, which means it’s not a “drug” that the FDA might notice.  Say thanks to our Congress, who passed the Complementary and Alternative Medicine Act that allowed manufacturers to market physiologically active substances with no established benefit.  Another in an ever-lengthening line of unregulated remedies that do more harm than good.

 

Recommended Reading:

--In Praise of Prejudice: The Necessity of Preconceived Ideas, by Theodore Dalrymple.  Most won’t care for this book because it points to how language distorts how we think.  In our day to be “prejudiced” is wrong.  But the word comes from the concept of “pre-judging”, a process that allows us to make decisions in the absence of complete information.  Dalrymple makes the case that we couldn’t get through our day without doing this.  It’s sobering to realize, but controversial only to ideologues.  What’s controversial is his claim that we can never operate without prejudice, and that its presence is good.  Thought-provoking, and while a serious work, not dry-as-dust academia.

--Boom! Voices of the Sixties: Personal Reflections on the ‘60’s and Today, by Tom Brokaw.  I was a little dubious about this:  I’ve seen too many “faded glory” books on the 60’s.  But this is very light reading, and while it’s a little heavy on the “radical chic” crowd, it’s not uncritical.  It was also fun to reflect on what I thought then, what I persist in thinking, and what I’ve discarded…especially the parts where I was very na├»ve.

 

Doc D

Opinions are entirely my own.  Quotations from Kaiser Daily Health Policy Report ( © Kaiser Family Foundation), PND News Briefs – Texas Edition ( © 2008, Physician's News Digest, Inc.), AMA Morning Rounds (© U S News Custom Briefings), Quackwatch.com, JunkScience.com, and other sources in the public domain.  As always, you may share this column, with appropriate attribution (here and in the text) included.

 

 

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