Yet another example of why the FDA ought to be abolished

So I’ve been sick for a few days (swine flu?) and have been staying home and going stir crazy. Lack of exercise and the general misery of being sick have meant a lot of late night TV for me. Last night, for the first time, I got a chance to see the new Animal Planet show I’m Alive.

There are actually three incarnations of this show – two are on Discovery networks and one is on the A&E network Biography (survival in general is an extremely popular theme of late). I’m Alive deals mainly with surviving animal attacks. The other two are the original I Shouldn’t be Alive which deals with surviving excursions into the wilderness or onto the ocean, and I Survived, which in general deals with surviving crime, but not always.

One of the benefits of this particular type of show is that it makes evident to people just how dependent they are on a properly functioning civilization. My hope is that at least a few people are making this connection (and making it properly, i.e., not equating civilization with socialism). Nevertheless, the episode I saw last night (actually the first of the series) of I’m Alive serves as a nice reminder.

A teenage boy, Mike Makens, is bitten by a black widow spider that had been hiding in his sock. His family rushes him to the hospital only to discover that there is no FDA approved antivenin available. Mike is having an unusually bad reaction to the spider venom, is in excruciating pain, and is in danger of suffering permanent nerve damage. The only treatment available in the US could kill him.

Mike’s parents are obviously intelligent people and they are unwilling to risk Mike’s life on a dangerous treatment. And they discover, via the internet, that a non-toxic antivenin exists and is available in Mexico. Mike’s step-father makes the decision to go to Mexico and smuggle the three needed vials of antivenin into the US to save Mike’s life. He recounts the harrowing story of smuggling the antivenin vials out of Mexico, carrying them onto the plane despite warnings that no liquids are allowed, and then into the US, where the antivenin is potentially illegal, all the while realizing that his son is only hours away from permanent nerve damage.

As luck would have it, he is not accosted by customs on either side of the border, who simply fail to check the open manila envelope carrying the antivenin vials (oh well, so much for the no liquids on a plane rule). But Mike is not out of the woods. The hospital has refused to treat Mike with the Mexican antivenin, fearing retaliation from the US government for using a non FDA-approved substance. Only after some pleading does Mike’s family manage to convince a doctor to help them administer the antivenin to him.

Throughout this episode, mind you, Mike’s step-father is shown wearing a shirt the same color orange as a typical prison jumpsuit. I don’t think this is a coincidence. But Animal Planet is sure to include a note which points out that a “loophole” in the law would have allowed the importation and administration of the drug, but only because there is no antivenin at all available in the US. How this importation was to have happened legally is another question.

Now, how many of you knew that if you were ever bitten by a black widow spider, a pretty damn ubiquitous spider in the US, that there would be no FDA-approved antivenin for you? This despite the fact that said antivenin exists in the world?

If this story does not sound familiar to you, you should familiarize yourself with the story of laetrile. Now, who wants to argue that antivenin is dangerous?

Reyn

25 Oct 2009 - 4:55 pm

While the case with Mike Makens pointed out on the “I’m Alive” show on Animal Planet does show an instance where the FDA is in the way of potentially life-saving treatments (as well as others, such as experimental cancer drugs), I hardly think that it definitively proves their incompetence and justifies abolishing them. They may be an impediment to drugs that could save the patient’s life, but they are also the mediating line that makes sure that said drugs are safe enough for general consumer use. From eSSortment.com (http://www.essortment.com/all/fdadrugapprova_rrgy.htm):
“All new drugs need proof that they are effective, as well as safe, before they can be approved for marketing. It’s important to realize, however, that no drug is absolutely safe. There is always some risk of an adverse reaction. But the FDA uses a cost benefit analysis to determine if the drug can be released to the public. The FDA determines that when the benefits outweigh the risks the FDA considers a drug safe enough to approve.”
You can argue that this causes lengthy stall periods where patients waiting for new medical treatments cannot receive them because the FDA blocks them, and that’s perfectly correct. However, the other extreme is that the FDA has little control and authorization, and many ‘drugs’ start to appear in stores that either do not work (sugar pills) or have an actually malignant effect on the patient.
In any case, the loophole technically did allow them to use the drug anyways. From Steamboat Pilot (local newspaper) (http://www.steamboatpilot.com/news/2007/oct/28/black_widow_spider_bite_prompts_parents_journey_me/)
“Fredeking and his legal team had also come across a 1980s FDA ruling that they believed would allow the drug to be transported and administered to Mike legally. Fredeking said the law allows for a foreign drug to be transported and administered if it is prescribed by a U.S. doctor, is not a narcotic and is not available in an identical form in the U.S.”
So then is it still grounds for removing the FDA? I hardly think so.

Now, the beef I found about the antivenin being unavailable in the US was that the US military uses it.

7 Comments

Mario
25 Oct 2009 - 1:40 pm

And yet some people want the government to have MORE control over our health care. Here’s another reason why we should get the government out of our health care decisions.
I will say that there are also US-made drugs that are very benefician for many treatments for cancer that are banned even in the european union, so it works both ways.
Reyn
25 Oct 2009 - 4:55 pm

While the case with Mike Makens pointed out on the “I’m Alive” show on Animal Planet does show an instance where the FDA is in the way of potentially life-saving treatments (as well as others, such as experimental cancer drugs), I hardly think that it definitively proves their incompetence and justifies abolishing them. They may be an impediment to drugs that could save the patient’s life, but they are also the mediating line that makes sure that said drugs are safe enough for general consumer use. From eSSortment.com (http://www.essortment.com/all/fdadrugapprova_rrgy.htm):
“All new drugs need proof that they are effective, as well as safe, before they can be approved for marketing. It’s important to realize, however, that no drug is absolutely safe. There is always some risk of an adverse reaction. But the FDA uses a cost benefit analysis to determine if the drug can be released to the public. The FDA determines that when the benefits outweigh the risks the FDA considers a drug safe enough to approve.”
You can argue that this causes lengthy stall periods where patients waiting for new medical treatments cannot receive them because the FDA blocks them, and that’s perfectly correct. However, the other extreme is that the FDA has little control and authorization, and many ‘drugs’ start to appear in stores that either do not work (sugar pills) or have an actually malignant effect on the patient.
In any case, the loophole technically did allow them to use the drug anyways. From Steamboat Pilot (local newspaper) (http://www.steamboatpilot.com/news/2007/oct/28/black_widow_spider_bite_prompts_parents_journey_me/)
“Fredeking and his legal team had also come across a 1980s FDA ruling that they believed would allow the drug to be transported and administered to Mike legally. Fredeking said the law allows for a foreign drug to be transported and administered if it is prescribed by a U.S. doctor, is not a narcotic and is not available in an identical form in the U.S.”
So then is it still grounds for removing the FDA? I hardly think so.

Now, the beef I found about the antivenin being unavailable in the US was that the US military uses it.
Lisa
27 Oct 2009 - 12:05 pm

Hi Reyn,

Your comments brings up some good points that might be on the minds of other readers, so I’ve decided to respond to you with a post: More on the FDA. Hope this helps to clarify things.

Lisa
John W
18 Jan 2010 - 9:07 pm

I’m a Burbank, Ca resident,

There are tons, I mean millions of black widow spiders here in Burbank. Everytime I go to my backyard, patio, trashbin, and see the heavy spider web, it’s redflag to me, and guess what? there it is, the black widow. I can’t believe that there’s no serum, right here in Los Angeles.? what in the world!
Alex Falconi
24 Jun 2013 - 4:05 pm

The loophole is actually a common law affirmative defense called “Necessity”. Under the doctrine of necessity, one can violate the law but, by proving “necessity”, exculpate him or herself.
Ray
13 Aug 2013 - 3:04 am

The FDA should be abolished and the people working there should be brought up on charges of mass murder. We have known how to cure most disease since 1930 discovered by Dr. Royal Rife.

Dr. Ken Beck who cured 4000 HIV cases at 80 different hospitals using his relay pulser device is just a recent example. Naturally, Dr. Beck unexpectedly died.

I built and used that Beck device on myself when I had sepsis and antibiotics would not cure it. I had my hearing back and the infection wiped out in 8 hours. I used the device (Illegal in the US) for two minutes.

If I got a spider bite, I would use that device as it destroys enzymes and bacteria which is a lot of what venom is.

The US government has lost ALL CREDIBILITY on so many fronts, I wonder why we pay taxes? The zionist own your government and killing gentiles is the name of the game for them. HIV does not affect the Ashkenazi for example…
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