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FDA Under The Gun
By Bonnie Jenkins, Advanced Natural Medicine Bulletin
Maybe we should call it paxil-gate. Or how about the serotonin scandal? Whatever you call it, one thing is clear, something’s fishy at the FDA.
Of course, if you’re a regular reader, you already knew this, so what follows won’t come as much of a surprise.
Frightening trends
About a year ago, I told you that the FDA had approved Prozac for kids who suffer from depression. Since then, prescriptions for a variety of antidepressants have skyrocketed. And, the fastest growing group is . . . preschoolers!
Now, that’s just plain wrong. Imagine, doctors and parents deliberately drugging three and four year olds. What are they thinking?
As if this news wasn’t outrageous enough, the FDA based its decision to approve antidepressants for children on just two studies that showed that Prozac was more effective than placebo in battling pediatric depression. The only problem these two studies found was that the normal rate of growth was slowed in the children taking the drug. At least that was the only problem the FDA told us about.
But now it seems there’s a much deadlier side effect for both children and adults who take Selective Serotonin Re-Uptake Inhibitors (SSRIs) like Prozac, Zoloft, Paxil. And it’s one the FDA knew about all along.
The man who knew
A couple of weeks ago, FDA officials admitted that they barred the agency's top expert from expressing concern about his conclusion that antidepressants cause children to become suicidal. Why? Because they thought his findings were alarmist and premature.
Dr. Mosholder, an FDA epidemiologist, was the man charged with analyzing 22 studies involving 4,250 children and seven drugs. After reviewing the data, Dr. Mosholder noticed that they showed a disturbing number of problems listed under the category, "emotional liability." Suicidal thoughts and self-injurious behavior were among the things lumped into this category.
Dr. Mosholder asked GlaxoSmithKline to provide more detail about these cases and in May 2003, the company submitted a new unpublished report. It clearly showed that children given Paxil were more likely to become suicidal than those given placebos. The agency then asked for similar data from the makers of Prozac, Zoloft, Luvox, Celexa, Wellbutrin, Effexor, Serzone and Remeron.
After reviewing all of the evidence, Dr. Mosholder found that 108 of the 4,250 children had done something that merited being called suicidal. He divided the cases into those who were given drugs and those given placebos and found that children given drugs were almost twice as likely to become suicidal as those given placebo.
Based on these findings, he urged the FDA to discourage doctors from prescribing all antidepressants except Prozac to children (According to Dr. Mosholder, Prozac is the only antidepressant proven effective in treating depressed children, and its studies showed no link with suicide). But Dr. Mosholder's supervisors, Drs. Mark Avigan and Anne Trontell, disagreed.
On February 2nd, health officials convened a special advisory committee to review the evidence and offer guidance on how the agency should respond to the studies. But, although Dr. Mosholder was scheduled to speak, he was removed from the agenda.
So who is the FDA protecting? Certainly not children. Unlike British authorities, who have all but banned the use of SSRIs for children, the FDA has once again come down on the side of drug companies. But this time, their actions may come back to haunt them.
Political protest
Like most cover-ups, this one started to unravel when some members of Congress started asking questions. On Thursday, April 22nd, U.S. Representative Joe Barton (R-TX) ripped into the FDA, noting that “There are troubling questions of whether FDA supervisors inappropriately suppressed significant information that would have been of consequence to their own advisory committee, not to mention the public.” Barton is the chairman of the Committee on Energy and Commerce, the Congressional subcommittee investigating what the FDA knew and when they knew it.
Lawmakers aren’t the only folks expressing outrage. According to Dr. Joseph Glenmullen, a clinical psychiatry instructor at Harvard University, "Those of us who've been following this have known for years that these problems exist. It's grossly irresponsible that they (the FDA) withheld this information.”
Vera Hassner Sherav, head of the advocacy group Alliance for Human Research Protection, said the FDA's arrogance is incredible. "Why are children less important?" Sherav asked. "Even if you have a small doubt, should you not err on the side of caution?” I couldn’t agree more.
When all is said and done, the evidence may point to even more disturbing possibilities. Many experts contend the same neurological changes generated by SSRIs that can lead to suicide can also spark violence toward others.
One last thing . . .
So what is likely to come out of the Congressional investigation? Will the FDA’s feet really be held to the fire? Probably not. The best we can likely hope for are warning labels on anti-depressants.
But maybe, just maybe, this will encourage consumers to take a closer look at how the FDA really operates. Meanwhile, I’ll stay on top of this issue and keep you posted.
This just in . . .
If you live a sedentary life, just the thought of exercise can be painful. But, according to a new clinical trial, you may be able to ease into a fitter lifestyle with the help of an ancient Chinese remedy.
The Chinese began using cordyceps mushrooms around 1,500 years ago after herdsmen in the Himalayas noticed a significant increase in their herds' strength and agility after eating it. Now a group of Massachusetts researchers have discovered that that this magic mushroom has the same effect in people.
During the 12-week study, the researchers measured the exercise capacity, endurance and metabolic changes in 131 people before, during and after receiving either cordyceps extract or a placebo. The results, which were recently presented to the American Physiological Society, were impressive, to say the least.
Among those taking the cordyceps, the volume of oxygen consumption went up 5.5 percent, compared to just 2.2 percent in the placebo group. This translated to some real, measurable results. For instance, the time taken by the participants to complete a one-mile walk was reduced by 29 seconds in the mushroom group but actually increased slightly in the others. And diastolic blood pressure fell by 3.2 percent among the people taking the remedy.
The results showed such marked improvement, even the researchers were surprised. According to a statement by the study’s authors, this is the first time cordyceps have been scientifically shown to enhance aerobic exercise capability, endurance and metabolism while alleviating fatigue in healthy humans.
So if you’re looking to start an exercise routine, but worry about discomfort and lackluster performance when you first begin to work out, give cordyceps a try. It may just give you the jumpstart you’ve been looking for in your quest for a healthier, more active lifestyle.
***
References:
“FDA muzzled antidepressant critic: report.” HealthScout. 16 Apr 2004.
Fox M. “Fungus may boost the old, out-of-shape – conference.” Reuters. 20 Apr 2004.
Waters R. "Drug Report Barred by FDA - Scientist Links Antidepressants to Suicide in Kids" San Francisco Chronicle. 1 Feb 2004. sfgate.com |
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