Re: O/T Santa Cruz doctor helps save lives of family who ate poisonous mushrooms

[Guest guest]

It's a shame that the doctor had to go through all that " re-tape "

just to get the remedy to save someone's life. And then to also have

to wait for FDA " approval " .... This system is so backwards. If we

know something natural works that will save a life it should be

readily avaiable for use.

But, I know, it's about the " money " (if you can call Federal Reserve

Notes money?)

Anyway, this is an amazing story!

Dana

--- In , " tigerpaw2c " <tigerpaw2c@...>

wrote:

>

> Santa Cruz doctor helps save lives of family who ate poisonous

> mushrooms

> By JONDI GUMZ - Sentinel staff writer

> Posted: 01/12/2009 01:30:05 AM PST

> http://www.mercurynews.com/centralcoast/ci_11432584

>

> Click photo to enlarge

> Mushroom gathering is safe if you know what to look for. Visitors

> to... (Bill Lovejoy/Sentinel)«123»Dr. Todd 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 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, and Dr.

> Knapp treated a family of six who had eaten tacos made of

> death cap mushrooms they picked at Wilder Ranch State Park.

>

> Searching Google, 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, 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 .

>

> This time, the patients included 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.

>

> 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,' " said, so he

> called the FDA.

>

> Five months after the FDA designated 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, "

> 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 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.

>

> called Dr. 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 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. Ganzert answered and agreed to help.

>

> 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 furt 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.

>

> didn't have that number -- yet.

>

> Within hours of his call, the FDA phoned . 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 furt was sold out. The next flight would depart four

> hours later and arrive in San Francisco as rush hour traffic began.

>

> 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.

>

> 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 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 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, "

> 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. "

>

> Contact Jondi Gumz at 706-3253 or jgumz@...

>

>

> 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 Hobbs and Dr. Todd

>

>

> 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 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?

> n Last year, California recorded 358 people treated for mushroom

> ingestion.

> n Seventeen ended up in intensive care.

> n Five experienced liver failure requiring a transplant, which can

> cost close to $1 million, or ongoing dialysis.

> n One died.

> Source: California Poison Control

>

[Guest guest]

If anybody wants to read about this therapy and how it works..

http://www.ncbi.nlm.nih.gov/sites/entrez?term=legalon OR silymarin AND amanita

I also have read this about it..

Maybe Dr. Thrasher can translate the important part..

http://www.ncbi.nlm.nih.gov/pubmed/19041708

Drug-drug interactions of silymarin on the perspective of pharmacokinetics.

Wu JW, Lin LC, Tsai TH.

Centers for Disease Control, Department of Health, Taipei, Taiwan;

Institute of Traditional Medicine, School of Medicine, National

Yang-Ming University, Taipei 112, Taiwan.

Silymarin, which is extracted from the milk thistle (Silybum

marianum), has been used for centuries for treating hepatic disorders

and its hepatoprotective effects have been known for hundreds of

years. Silymarin is a mixture of polyphenoic flavonoids, which include

silibinin (silybin A and silybin , isosilyin A and B, silychristin A

and B, silydianin and other phenol compounds. The pharmacokinetics of

silibinin shows fast absorption and elimination. Silymarin undergoes

phase I and phase II metabolism, especially phase II conjugation

reactions, it undergoes multiple conjugation reactions, and is

primarily excreted into bile and urine. Silymarin has a good safety

profile,

*but little is known regarding its potential for drug interaction.* *

Silymarin has limited effect on the pharmacokinetics of several drugs

in vivo; despite silymarin decreasing the activity of cytochrome P-450

(CYPs) enzymes, UDP-glucuronosyltransferase (UGT) enzyme, and reducing

P-glycoprotein (P-gp) transport.*

*Health-care practitioners should caution patients against co-administration

of silymarin and pharmaceutical drugs.*

PMID: 19041708 [PubMed - in process]