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

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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

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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