Every now and then, when a study comes along that just doesn't add up, I find myself wondering: What the heck was in that placebo?
In placebo controlled clinical trials that the medical mainstreamers are always holding up as their sacred "gold standard," the placebo pill is assumed to be inert. In fact, it's a blind spot.
In trials financed by drug companies, the company supplies the placebo and controls the ingredients. The FDA does not oversee placebo ingredients. No one does.
So for instance, if a drug prompts a side effect, such as howling at the full moon, drug company execs might be tempted to include something in the placebo that would also prompt full moon howling. That way, the published write up of their study would simply note that side effects were similar in both groups.
That's just one way a placebo with a little something extra might tweak study results.
Which brings us to a new trial that tested Chantix, a best selling smoking cessation drug. I'm not saying there were any disreputable hijinks involved with this research. But some of the details had me wondering: What the heck was in the placebo?
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Powerful stuff
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UCLA researchers put Chantix up to a very difficult test: COPD.
According to Dr. Donald Tashkin, the leader of the UCLA study, Chantix came through like a champ!
This is impressive because Dr. Tashkin tells Reuters Health that cigarette smokers with COPD (a debilitating and steady deterioration of the respiratory system) actually find it harder to quit smoking than smokers who have avoided the disease.
The UCLA team recruited about 500 smokers with COPD. On average, subjects were in their late 50s and had been smoking for about 40 years. For 12 weeks, half the group received Chantix while the other half received a placebo.
Results: One year after the beginning of the study, nearly 19 percent of the Chantix group had successfully refrained from smoking, while nearly six percent of the placebo group had quit.
Considering how hard it is for COPD patients to quit smoking, I suppose that one success story out of every five attempts might be considered an impressive result.
But what's really surprising is that ANYONE in the placebo group was successful. I mean, you have a disease that makes it harder to quit, but still, you successfully kick the habit after FOUR DECADES of steady smoking.
Hmmm. That's an unusually powerful placebo effect!
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Bad ideas
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Here's where the study gets very fishy: side effects.
You may remember Chantix dangers from several previous e- Alerts. For instance, in the first quarter of 2008, the number of serious reactions reported to the FDA was higher with Chantix than with all of the 10 best selling brand name drugs COMBINED.
One year later, the FDA required Pfizer, the maker of Chantix, to include a Black Box Warning that the drug might prompt depression, suicidal ideation, and suicidal actions.
In the UCLA study, Chantix side effects included nausea, insomnia, and abnormal dreams. But serious side effects were MORE common in the placebo group. And no one in the Chantix group reported suicidal ideation, but one person in the placebo group did.
Wow. That is an astounding placebo effect!
But wait -- before we ask the question -- I have two more details: 1) The trial was funded by Pfizer, and 2) Dr. Tashkin is a consultant for Pfizer.
Okay? All together now: What the HECK was in that placebo?
I don't believe there's enough champagne in France to accommodate all the celebrating that must be going on at drug companies these days.
Well, not ALL drug companies. Just the five that have a sweet piece of the H1N1 vaccine action.
So far, the U.S. has ordered 195 million doses of the vaccine. But don't be surprised when that number goes higher. A few days ago, the FDA approved the use of Australia's CSL Limited H1N1 vaccine in children 6 months and older. Previously, the approval was only for teens and adults, 18 years and older.
And an added bonus: The approval includes CSL's seasonal flu vaccine. So just imagine the delirious joy this news must have brought the vaccinators at CSL.
The vaccine is available in two forms: 1) A single dose that's preservative-free, or 2) a double dose that contains thimerosal, the mercury-based preservative.
Hmmm. Now, why in the world would they make one form with a double dose of mercury, and another single-dose form with zero mercury?
Could it be because many parents who (wisely) suspect the shot is unnecessary would quickly opt out if their only choice included thimerosal?
Television medical pundits are quick to dismiss any link between thimerosal and autism. They call it "junk science" and no one ever questions them. But the mercury is still there. And mercury is still a neurotoxin. And many parents (wisely) ignore the assurance that it's perfectly safe to inject this heavy metal into ANYONE -- particularly infants.
To Your Good Health,
Jenny Thompson
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