FDA

Life, Death, and Red Tape

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Earlier this month, a Santa Cruz, California family inadvertently ate some poisonous mushrooms they'd collected in a nearby woods. The "death cap" mushroom they ate is often fatal, and there's no antidote approved for use in the U.S.

The doctor on call at Dominican Hospital did a search on Google Scholar, and found that in some parts of Europe, intravenous administration of an extract from the milk thistle plant had been used to effectively treat poisoning from this particular variety of mushroom.

Enter the FDA. The treatment isn't approved in the United States. So the doctors next embarked on a harrowing battle with various bureaucracies to get the drug to the U.S. from the manufacturer in Germany in time to treat the family.

The good news is that they succeeded, and managed to save five of the six patients.

Story here .

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  1. You know what would really make this blog post jump off the page?

    A link.

  2. yes, link please.

  3. “Antidote”

  4. Minor quibble: I believe you mean “antidote” not “anecdote.”

    Funny, there is milk thistle extract being used to treat kidney problems in animals now. Wonder why they felt they needed to go to Germany to get it.

  5. This one time, at mushroom camp, I put a death cap mushroom in my ….

  6. THAT’S why he can’t post the link.

    Because there’s no anecdote approved in the US.

    It all makes sense…

  7. de stijl,

    I think I’ve heard that antidote before…

  8. Any libertine should know about milk thistle. I take it every day.

    http://www.umm.edu/altmed/ConsHerbs/MilkThistlech.html

  9. inadvertently ate some poisonous mushrooms they’d collected in a nearby woods

    How do you “indavertently” eat something that you picked.

    They obviously picked mushrooms that they shouldn’t have. But I bet they ate them on purpose.

  10. Haaa haaaa! Haahaaaa! That’s the funniest anecdote I’ve ever heard!!! Now you tell one.

  11. If the extract is not approved by the FDA, how can we be sure that it is safe and effective? What if it has side effects?

  12. I’m sure the family of the one who died is thankful the FDA didn’t let him get a treatment that they hadn’t approved yet. I mean, that might have killed him.

  13. Look, I’m all in favor of having access to any anecdote that might work, but one antidote is hardly statistically significant evidence that the anecdote works.

  14. I was all set to be angry at the FDA but the article indicates they gave emergency permission within hours of getting the request and wasn’t a factor in delivering the medication. In fact, the only pricks in the story were a pharmaceutical company.

  15. “That same day, the FDA granted the permission needed. Under FDA regulations, the agency doesn’t discuss investigative new drugs but Madaus Pharma confirmed that the approval came swiftly.

    “Surprisingly he was able to get this within a matter of hours,” said Veilleux. “People were asking me, ‘What are the chances he’ll get permission?’ I said, one in 1,000”

    You read this part and you really have to wonder what Radley is on about here.

  16. “you really have to wonder what Radley is on about here”

    He’s just shilling for Big Thistle.

  17. “antidote” is fixed; now, on to “beuracracies.”

  18. I’d think the real story here is that the FDA managed to move quickly, on behalf of a self-administered poisoning.

    Can we send the “victims” a bill?

  19. beuracracies

    Is John now blogging at Hit and Run?

  20. Death Cap mushrooms, sauteed in Beurre Blanc, are as delicious as they are deadly.

  21. Death Cap mushrooms, sauteed in Beurre Blanc, are as delicious as they are deadly.

    OK, now I have this idea for a Hannibal Lecter story. He hosts an elegant dinner, serving the dish you describe as an appetizer for the guest of honor…

  22. …Ahhh, the FDA! Our savior since it’s inception, founded primarily to stop the “southern negroes” from using cocaine and going “crazy, raping and killing every white they see”. Good ole racist institution devised to avoid actually making an amendment to the constitution outlawing drug use ( the only truly lawful method ). Funny, now it’s used to further enrich the pharmacuetical corps, maybe the german company doesn’t give enough payola to the FDA to get their approval.

  23. Death Cap mushrooms, sauteed in Beurre Blanc, are as delicious as they are deadly.

    You don’t saute in a Beurre Blanc. Beurre Blanc is a reduction sauce of white wine, shallots and cold butter.

    You saute something (fish, chicken, etc.) in butter, oil or a combination and then serve with a Beurre Blanc sauce.

  24. A story about the FDA getting in the way of effective treatment sounds like good anecdote to me.

  25. Yeah is this supposed to be bashing the FDA, or making us want to end the drug war, so people can get mushrooms in stores?

    Either way, go Reddit.

  26. Inadvertently?

  27. Stupid Santa Cruz hippies . . .

  28. Isn’t this Sullum’s beat? The government interfering with the recreational use of Death Cap mushrooms?

  29. Isn’t this Sullum’s beat? The government interfering with the recreational use of Death Cap mushrooms?

    Good point…I didn’t see a S.W.A.T.team anywhere in the article.

  30. Since it was Radley posting this, and Santa Cruz (home of my alma mater) is in the post description, I just assumed that they ate the mushrooms to get high… wouldn’t you?

    But in fact, they were just hungry, and the Amanita phalloides bears no resemblance to the Psilocybe family of psychedelic mushrooms. Notably, the ‘death cap’ mushroom is described as tasting delicious.

  31. “Notably, the ‘death cap’ mushroom is described as tasting delicious.”

    Was this little tidbit of information revealed to you at a seance?

  32. Notably, the ‘death cap’ mushroom is described as tasting delicious.

    That was the best, damn, mushroom, I…gurgle…ever…wheez…ate…thump!

  33. Mortality from Amanita poisoning runs about 15-20 per-cent.

    I’m no fan of the FDA, but I’m betting the “antidote” didn’t do a thing.

  34. I’m no fan of the FDA, but I’m betting the “antidote” didn’t do a thing.

    Probably right, if it is not approved by the FDA then it is not safe and effective.

  35. Not sure if they were hippies. Haven’t seen too many Hippies from Mexico.

    But the person who died was the 83 year old grandmother. Not sure if they had the medicine on hand if the 83 year old grandmother would have survived.

    http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2007/01/13/BAG0INI8OB1.DTL&feed=rss.bayarea

  36. I think everyone is missing the biggest part of the story:

    Google saves lives.

    Just imagine if Windows 95 had been responsible for saving 5 out of 6 members of a family. Bye-bye anti-trust lawsuit.

  37. But in fact, they were just hungry, and the Amanita phalloides bears no resemblance to the Psilocybe family of psychedelic mushrooms.

    True, but it is closely related to amanita muscaria, which does have psyechedelic effects.

    Or so I’m told.

  38. “Notably, the ‘death cap’ mushroom is described as tasting delicious.”

    Was this little tidbit of information revealed to you at a seance?

    It was revealed in a Scientific American article I remember reading decades ago. The author sauteed them in butter, and cold bloodedly wrote, “There was no danger, as I did not swallow any.” How’s that for rough and ready, in your face, all in, foot to the floor science, and science writing? The most memorable sentence I’ve seen in all of biochemistry.

  39. “Notably, the ‘death cap’ mushroom is described as tasting delicious.”

    Was this little tidbit of information revealed to you at a seance? [fixed the tag]

    It was revealed in a Scientific American article I remember reading decades ago. The author sauteed them in butter, and cold bloodedly wrote, “There was no danger, as I did not swallow any.” How’s that for rough and ready, in your face, all in, foot to the floor science, and science writing? The most memorable sentence I’ve seen in all of biochemistry.

  40. Doctors! Always meddling with nature!

    Subverting the natural mechanism of the food chain i.e. the dumb usually die first, only upsets our natual balance with the planet.

  41. They bloody hell shouldn’t have had to ask permission of the FDA in the first place!

  42. The FDA has likewise kept the most effective sunblock ingredient, Mexoryl, out of the USA for the past ten years…protecting Americans from protecting themselves from the sun. (They only approved it recently.) In those ten years it was prohibited, not one person in Europe dropped dead from sunblock use — although many died of malignant melanoma here in the USA!

  43. although many died of malignant melanoma here in the USA!

    1. First of all, the over the counter stuff works if you use it. I don’t think Mexoryl would have helped those people who couldn’t be bothered to pick up and use the ol’ spf 40 on an otc basis.

    2. Link to the medical research study that showed Mexoryl to be most effective against the rays that cause the tumors? Or is your information on effectiveness of mexoryl less formal than that, Amy Alkon? What are the side effects if you eat it or get it into your eyes? Do you even know, Amy Alkon?

    3. My grandfather died of skin cancer. Without going into all the details he lived at a location and in a lifestyle that would have seemed to put him at quite a low risk for skin cancer. But he got it bad. Certain members of my family (me included) came to believe that the skin cancer was a delayed result of radiation treatments he received for his acne when he was still a teenager. They don’t give those kind of radiation treatments anymore. The FDA let doctors get away with things in the 1930s that would not fly today. It is a good thing, too. I had acne as a teen, just like Grampy, but I don’t want to catch skin cancer in my early 50s and die in my early 60s if it can be helped.

  44. 1. First of all, the over the counter stuff works…

    Agreed, however Mexoryl blocks UVA, others only block UVB. I believe UVB causes burns while UVA causes cancer.

    2. Link to the medical research study that showed Mexoryl to be most effective…

    See pubmed:

    http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?CMD=search&DB=pubmed

    I believe a topical product used for dacades around the world should not require the same scrutiny as an invasive treatment like radiation. Can’t we have different standards of proof.

  45. I registered at pubmed, but the link does not bring up an article.

    I am interested in this topic and would like to read more about it.

    Some random observations on the whole Mexoryl thing:

    1. I am not neccessarily defending the FDA here. Most people in the real world would probably consider me hostile to the FDA. it is only at HnR that I sometimes feel i need to defend them from unfair attacks.

    2. As I said on a previous thd here, the likeliest explanation is that Mexoryl’s maker is taking steps to time the approval to maximize patent positioning. They will get 14 years of monopoly in the US pretty much regardless. the only issue for them is when that 14 year monopoly will be timed, now or later.

    3. As far as I can tell, the intial FDA application for Mexoryl was made in 2001:

    http://www.dermatologytimes.com/dermatologytimes/article/articleDetail.jsp?id=124910&pageID=2

    If this is true it means that there was a private sector delay of 8 years to wait for an application to be filed, and then a 5 years delay to wait for the FDA to do safety and effectiveness testing. Five years isn’t gr8, except when compared to the 8 year delay.

  46. Oh, come on. This whole article is a giant apologia for alternative medicine. “Well, it’s ‘natural’ and ‘has been used for thousands of years’, so obviously it must work.” What bullshit.

  47. Okay, Cain, then what year was a mexoryl application first made with the FDA?

    I mean if we are going to get all in a knot about the delay here, we really should figure out the answer to this simple question.

  48. From your comments, Sam, I think we’re on the same side on this. I was referring to the original article that Radley posted, not the mexoryl article. Sorry if that was unclear.

  49. Is this the English department version of Slashdot?

  50. Cool. I was looking for a way to work in the point that I don’t even think it has been publically revealed when the meroxyl application was filed. the article I linked had to guess and could not even get a confirmation on the filing date. That in itself should tell a savvy guy like Mr. Balko something as he shifts gears and begins to write on FDA related topics here.

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