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InvisibleveggieM

Registered: 07/25/04
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Santa Cruz doctor helps save lives of family who ate poisonous mushrooms [CA]
    #9593760 - 01/12/09 08:18 AM (15 years, 1 month ago)

Santa Cruz doctor helps save lives of family who ate poisonous mushrooms
January 12, 2009 - Mercury News

Dr. Todd Mitchell was awakened by a phone call at 8 a.m. on the Tuesday after Christmas.

A woman and her twin 11-year-old grandsons had eaten soup made from deadly mushrooms they picked in the woods. Dr. Kent Olson of California Poison Control was asking for the phone number of the German company that makes a drug used to treat death cap mushroom cases in Europe.

The call gave Mitchell chills.

He knew mortality from death caps is higher for children.

He felt a sense of urgency, and the situation was hauntingly familiar.

Two years ago in January at Dominican Hospital, Mitchell and Dr. Wendy Knapp treated a family of six who had eaten tacos made of death cap mushrooms they picked at Wilder Ranch State Park.

Searching Google, Mitchell found a treatment used in Europe, an intravenous milk thistle preparation called Legalon-Sil. He had persuaded the Food and Drug Administration to allow its use as an emergency investigational new drug. He arranged for an air courier to deliver the medication to the San Francisco hospital where four of the six patients had been taken after developing liver failure and needed transplants.

None of the patients underwent transplants. All recovered but one, the 83-year-old grandmother. Her liver recovered but she succumbed to kidney failure.

Afterward, Mitchell prepared a report on the treatment for the FDA and made a presentation at a European toxicology conference in Seville, Spain.

Now, he was being asked if he could retrace his steps, procure the intravenous milk thistle, obtain FDA approval and get it to San Francisco the very next day.

"It was like deja vu all over," said Mitchell.

This time, the patients included Sarah Elbert, 72, a retired history professor and lifelong mushroom hunter from Ithaca, N.Y. While visiting her grandsons in San Francisco Bay Area, she had taken them mushroom picking on Mount Tamalpais in Marin County the Sunday after Christmas, and made soup.

Twelve hours later, all three were vomiting and experiencing diarrhea. Twice they went to the hospital, then were discharged.

When the symptoms worsened, the family returned to the hospital, where they were told to drive to UC San Francisco Medical Center, which has a pediatric liver transplant unit.

Mitchell called Joe Veilleux of German drug maker Madaus in Pittsburgh.

Veilleux told him Madaus' offices in Germany were closed for the holiday and wouldn't reopen until Jan. 5. The same was true for an Italian company that bought Madaus six months after the Santa Cruz mushroom poison case.

"He told me I don't know what you will do,' " Mitchell said, so he called the FDA.

Five months after the FDA designated Mitchell the lead investigator for using milk thistle to treat the Santa Cruz patients, he submitted his research paper to the agency. Madaus invited him to attend a meeting three months later with FDA officials, where the company asked about prospects for agency approval of Legalon.

"The cost of seeking approval was going to be astronomical," Mitchell recalled.

Yet the payback for Madaus would be limited. There is not a huge market for the drug in the U.S. Mushroom poisoning is more common in Europe than in America.

The meeting ended with the FDA interested but not yet willing to grant permission for milk thistle extract, or silybinin, to be stocked in America for emergency use.

When Mitchell rang the FDA, he asked if he could use the identification number granted two years ago for Legalon, which would speed things up. He was told he would have to reapply for permission.

Mitchell called Dr. Thomas Zilker, a Munich toxicologist he had met at the conference in Seville, Spain. Zilker was considered the worldwide authority on the medical implications of amatoxin poisoning.

No one answered Zilker's phone so Mitchell searched through old e-mails looking for another connection. He found an office phone number for one of Zilker's colleagues. It was after 6 p.m. in Munich, but Dr. Martin Ganzert answered and agreed to help.

Mitchell asked for as much silybinin as the pharmacy had in stock. Nicola Clausius, clinical pharmacist at the Munich hospital, said she would try to get the drug onto the next Lufthansa flight to San Francisco, departing Frankfurt the next morning. She arranged for a personal courier. As she packed the drug in a box, she asked if he had the investigational new drug number the shipment required.

Mitchell didn't have that number -- yet.

Within hours of his call, the FDA phoned Mitchell. Staffers had met the Santa Cruz doctor and had seen the report he submitted the year before and decided to issue the requisite number.

Then the Munich pharmacist called with bad news. The first plane departing Frankfurt was sold out. The next flight would depart four hours later and arrive in San Francisco as rush hour traffic began.

Mitchell worried the special delivery would arrive too late for the twins, who were sicker than their grandmother.

He looked up Lufthansa online and found the flight was sold out -- but only in coach. Pricier business class seats remained.

Mitchell called the pharmacist's contact at Lufthansa, Oliver Serokca, explaining why the stakes were high. In 15 minutes, Serokca called to say he bumped a wait-listed passenger so the courier could take the flight that would arrive four hours earlier.

Next Mitchell confirmed with Veilleux that Madaus would cover the costs of the drug, the flight and the courier. Veilleux got the green light by reaching the head of company via cell phone at a ski resort in the Italian Alps.

But when the drug arrived the next morning there were only 14 vials rather than the 18 Mitchell had expected. If there wasn't enough medication for all three patients, who would get what?

Doctors decided to treat the twins first because of the higher mortality rate in children.

By the next morning, both boys improved, allowing what remained of the drug to be given to the grandmother.

She recovered and was discharged three days later. Her grandsons left the hospital eight days after ingesting the poison.

"I'm getting strong signals from the FDA that they may soon grant an open IND investigational new drug application for Legalon-Sil," Mitchell said Friday. "This would allow the antidote to be rapidly accessible from a California pharmacy after an amatoxin poisoning. We would then be able to collect safety data and track outcomes in the systematic manner necessary to gain ultimate FDA approval."

Why death cap mushrooms are deadly
Death caps -- amanita phalloides -- are big and fleshy and look like an edible variety. They taste good, not bitter, but contain amatoxin, one of nature's most deadly poisons, which destroys cells in the gut, kidney and liver. Amatoxin can't be destroyed by cooking, boiling, drying or freezing.
Source: Herbalist Christopher Hobbs and Dr. Todd Mitchell

History of milk thistle
The prickly appearing milk thistle contains a substance that has been used to support liver health for more than 2,000 years. In A.D. 23, Pliny the Elder recommended a mixture of milk thistle juice and honey for improving digestion by stimulating the flow of bile. During the 17th century, British herbalist Nicholas Culpeper prescribed milk thistle seeds for jaundice and obstructions of the liver.
Milk thistle became popular in American medicine around the turn of the 20th century, but fell out of favor -- except in Germany. During the 1970s and 1980s, German scientists began testing the plant to validate it as a liver herb. In 1998, milk thistle extracts accounted for over $180 million in herb product sales in Germany. Intravenous milk thistle is used in emergency rooms throughout Europe to treat poisoning.
Source: The Encyclopedia of Popular Herbs, Your Complete Guide to the Leading Medicinal Plants.

How common is mushroom poisoning?
*Last year, California recorded 358 people treated for mushroom ingestion.
*Seventeen ended up in intensive care.
*Five experienced liver failure requiring a transplant, which can cost close to $1 million, or ongoing dialysis.
*One died.
Source: California Poison Control

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InvisibleGreen_T
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Registered: 10/02/08
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Re: Santa Cruz doctor helps save lives of family who ate poisonous mushrooms [CA] [Re: veggie]
    #9593778 - 01/12/09 08:27 AM (15 years, 1 month ago)

Thats one hell of a story! I guess those milk thistle extracts they sell at supplement stores for "improving liver function" are semi-legit?


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"I have sworn upon the altar of god eternal hostility against every form of tyranny over the mind of man" - Thomas Jefferson

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Invisibletravelleler
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Re: Santa Cruz doctor helps save lives of family who ate poisonous mushrooms [CA] [Re: veggie]
    #9593817 - 01/12/09 08:41 AM (15 years, 1 month ago)

FUCK THE BUREAUCRACY... such a pile of bullshit he had to swim through, and all for a noble cause-- to save three lives... but of course the FDA can't just say, "yeah sure here you go"  no no no... first they have to :shrug: and then they have to twidle their thumbs and then maybe sometime later they will help out, sheesh


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:sun:Dreams are the fuel of the soul:sun:

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Invisiblefushock
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Re: Santa Cruz doctor helps save lives of family who ate poisonous mushrooms [CA] [Re: travelleler]
    #9594403 - 01/12/09 11:49 AM (15 years, 1 month ago)

They have to make sure a company patents the active chemical before they approve it. That way $$$

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InvisibleburtonRebel
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Registered: 12/02/06
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Re: Santa Cruz doctor helps save lives of family who ate poisonous mushrooms [CA] [Re: fushock]
    #9594458 - 01/12/09 12:04 PM (15 years, 1 month ago)

yeah! they're alive!


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Wreck yourself before you check yourself

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OfflineOphanim
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Re: Santa Cruz doctor helps save lives of family who ate poisonous mushrooms [CA] [Re: burtonRebel]
    #9595081 - 01/12/09 01:54 PM (15 years, 1 month ago)

Interesting. This Milk Thistle seems like a good thing to take on drinking nights.

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Offlinepfshroomer
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Re: Santa Cruz doctor helps save lives of family who ate poisonous mushrooms [CA] [Re: Ophanim]
    #9595944 - 01/12/09 04:21 PM (15 years, 1 month ago)

Man Ive never read so fast in my life..it was like watching a movie and reading all at the same time
I was so interested in seeing what was going to happen..
Peace


--------------------
"Follow the medicine path with an open mind and a clear heart, and you will surely find inner peace and enlightenment."

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OfflineAlan RockefellerM
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Re: Santa Cruz doctor helps save lives of family who ate poisonous mushrooms [CA] [Re: veggie]
    #9597663 - 01/12/09 08:26 PM (15 years, 1 month ago)

Quote:

Legalon-Sil




Its not a controlled substance, I wonder how hard it is to buy.

I cant find it on ebay unless its in milk thistle capsules.

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OfflineHagbardCeline
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Re: Santa Cruz doctor helps save lives of family who ate poisonous mushrooms [CA] [Re: travelleler]
    #9600368 - 01/13/09 09:04 AM (15 years, 1 month ago)

Quote:

travelleler said:
FUCK THE BUREAUCRACY... such a pile of bullshit he had to swim through, and all for a noble cause-- to save three lives... but of course the FDA can't just say, "yeah sure here you go"  no no no... first they have to :shrug: and then they have to twidle their thumbs and then maybe sometime later they will help out, sheesh




Really?  I definitely understand frustration with the FDA and some of their boneheaded policies but I don't understand your frustration with them in this case.  The "pile of bullshit" was mostly due to trying to reach the appropriate people and procure the medicine on another continent during the holidays.

The article stated that they phoned him in a couple of hours having approved his request.  That's pretty damn efficient by any bureaucracy but especially FDA standards.

Edit - The answer he was given when he first phoned the FDA was likely the result of getting the first tier responder.  They don't have the authority to make a judgment call like he needed and issued the response "by the book" while still escalating it to someone who could review it and make that call.


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I keep it real because I think it is important that a highly esteemed individual such as myself keep it real lest they experience the dreaded spontaneous non-existance of no longer keeping it real. - Hagbard Celine

Edited by HagbardCeline (01/13/09 09:15 AM)

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OfflineHagbardCeline
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Re: Santa Cruz doctor helps save lives of family who ate poisonous mushrooms [CA] [Re: Green_T]
    #9600379 - 01/13/09 09:08 AM (15 years, 1 month ago)

I too am somewhat surprised that milk thistle is in fact that effective at detoxifying the liver.  I always thought it another one of the naturalist's scams.

Still, it probably does no good in someone with a healthy liver who hasn't ingested a potent dose of toxin.


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I keep it real because I think it is important that a highly esteemed individual such as myself keep it real lest they experience the dreaded spontaneous non-existance of no longer keeping it real. - Hagbard Celine

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Offlinebeandip
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Re: Santa Cruz doctor helps save lives of family who ate poisonous mushrooms [CA] [Re: Ophanim]
    #11361570 - 11/01/09 09:17 AM (14 years, 4 months ago)

Quote:


Interesting. This Milk Thistle seems like a good thing to take on drinking nights.




Yeah as long as it doesn't have any reaction with alcohol hehe. I can't believe the costs that are associated with this herbal extract. Who the fuck can justify the "millions" it claims to cost when I honestly think some hillbilly could extract the stuff. Just my 2c but I don't understand why this wasn't only made readily available to someone who was a lead researcher but why this wouldn't be available for any mushroom toxin treatments. Time is of the essence when that shit eats your gut out! Just pull one bomb off the assembly line ok?

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OfflineMorgenstern
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Registered: 06/07/09
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Re: Santa Cruz doctor helps save lives of family who ate poisonous mushrooms [CA] [Re: veggie]
    #11361785 - 11/01/09 10:13 AM (14 years, 4 months ago)

What a bunch of fucking tards.

:nonono:


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OfflineHumility
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Re: Santa Cruz doctor helps save lives of family who ate poisonous mushrooms [CA] [Re: HagbardCeline]
    #11361971 - 11/01/09 11:02 AM (14 years, 4 months ago)

Quote:

HagbardCeline said:
Quote:

travelleler said:
FUCK THE BUREAUCRACY... such a pile of bullshit he had to swim through, and all for a noble cause-- to save three lives... but of course the FDA can't just say, "yeah sure here you go"  no no no... first they have to :shrug: and then they have to twidle their thumbs and then maybe sometime later they will help out, sheesh




Really?  I definitely understand frustration with the FDA and some of their boneheaded policies but I don't understand your frustration with them in this case.  The "pile of bullshit" was mostly due to trying to reach the appropriate people and procure the medicine on another continent during the holidays.

The article stated that they phoned him in a couple of hours having approved his request.  That's pretty damn efficient by any bureaucracy but especially FDA standards.

Edit - The answer he was given when he first phoned the FDA was likely the result of getting the first tier responder.  They don't have the authority to make a judgment call like he needed and issued the response "by the book" while still escalating it to someone who could review it and make that call.




On neither occasion should a physician have been required to ask the permission from outside parties to do business with another consenting  human being or group of such.  The FDA required that this man ask PERMISSION to be allowed to treat patients that I'd wager many of those FDA specialists had either limited knowledge of how to help. or little interest in helping.

What if they'd denied his "request"?  Free people don't have to ask permission from outsiders to act consensually.


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Offlinecyanophilus
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Registered: 06/08/09
Posts: 1,286
Loc: Bay Area, CA
Last seen: 7 years, 7 months
Re: Santa Cruz doctor helps save lives of family who ate poisonous mushrooms [CA] [Re: Humility]
    #11363187 - 11/01/09 02:47 PM (14 years, 4 months ago)

old news

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