Physician uses Google to Save Dying Family - Days from Death

January 15, 2007 2:33 AM

Physician uses Google to Save Dying Family - Days from Certain Death. Entire Family had Days to live from an almost 100% fatal poison. Physician finds experimental cure in Google Scholar — but it is not approved in USA. How do you get through theMassive FDA red tape in days, as the family is nearing the end? Compassionate manufacturers and a persistant Doctor all came together to help - with mere days left for family already in the process of dying. Read about the Miracles that finally occurred.
posted by Bodyguard (42 comments total)

Just Days to Live. Thank God for Doctors Miracles.
posted by quonsar at 4:02 AM on January 15, 2007 [3 favorites]

That's an excellent tale of resourcefulness and determination. I don't know if I'd ever throw myself into a raging torrent to try and save someone, but if I could do most of it from my laptop, we're on!

Great story, thanks for posting.
posted by imperium at 4:13 AM on January 15, 2007

Interesting stuff - now, if only people would work themselves into a righteous lather over the things the FDA doesn't approve ("folk remedies" like this milk thistle extract) to the same extent that they do over things that have been approved (e.g. aspartame) then perhaps the world would be a better place...
posted by Chunder at 4:22 AM on January 15, 2007

Can we try and be a bit less daily mail?

1. Their deaths were not certain without the treatment. In the last 4 years 8 of 17 severely ill patients at Pacific Medical survived (I assume without the new unapproved thistle treatment).
2. The massive FDA red tape didn't get in the way - approval was swift and within hours.
3. God clearly hates grandmothers - they don't get miracles.
4. "At the end of the day, we can't say whether it was the silymarin or dumb luck" - that is precisely the point of the "massive" FDA red tape.
posted by srboisvert at 4:22 AM on January 15, 2007 [6 favorites]

Cool story, hopefully there comes some research out of this which leads to approval of this drug in the States, as, according to the story,
"Milk thistle extract, or silymarin, has been used in Europe to treat cirrhosis of the liver, scarring that often proves fatal."
To me, a drug that has been in use for 20+ years and is still being produced can't be totally useless, and the side effects seem to be extremely mild.
Oh, and srboisvert, the point of FDA red tape is, theoretically, to protect people from harmful foods and drugs, not to prevent people from receiving, at worst, harmless medications. Note that the red tape took DAYS to cut through, most of it a result of the lack of FDA approval of this drug. IF this medication had been administered sooner, it is possible that grandma might still be alive. If not, at least we'd actually know that the medication didn't help.
Although you do get extra punk rock points for being so gosh-darned cynical-yet-appealing-to-authority. I mean, that level of cognitive dissonance is hard to maintain. FDA 4 Lyfe!
posted by eparchos at 4:31 AM on January 15, 2007

"Oh, and srboisvert, the point of FDA red tape is, theoretically, to protect people from harmful foods and drugs, not to prevent people from receiving, at worst, harmless medications."

No, that's wrong. The FDA is charged with ensuring that drugs are both safe and efficacious. The idea is that if you're already taking a placebo (or a useless herbal supplement), you're less likely to pursue other options that may actually help.

You'll notice the FDA doesn't prevent you from buying as much milk thistle extract as you'd like. In the absence of clinical studies, the FDA does prevent you from injecting milk thistle into your veins, or having your doctor prescribe it as a remedy for acute mushroom poisioning. Seems like a reasonable balance.
posted by Nahum Tate at 4:42 AM on January 15, 2007

The idea is that if you're already taking a placebo (or a useless herbal supplement), you're less likely to pursue other options that may actually help.

In case you missed it, there ARE no other treatment options for death cap poisoning, so it seems that the FDA red tape, in this case, was nothing but a hindrance.

In the absence of clinical studies...
You mean in the absence of FDA-approved clinical studies. Apparently European scientists and 20 years of use in medicine in Europe is not enough for the FDA. Meanwhile, the Europeans won't buy lots of food that our FDA approves, the Europeans have a higher average life expectancy and better health that Americans do... hmmmm.
posted by eparchos at 4:59 AM on January 15, 2007

Now, that's great, but when I find something on google and take it to a physician, I get laughed at... Miracles must go with medical titles, apparently.
posted by Laotic at 5:15 AM on January 15, 2007

You mean in the absence of FDA-approved clinical studies. Apparently European scientists and 20 years of use in medicine in Europe is not enough for the FDA. Meanwhile, the Europeans won't buy lots of food that our FDA approves, the Europeans have a higher average life expectancy and better health that Americans do... hmmmm.

The NHS in the UK funds magnetic therapy eparchos. Would you like that to be a doctor prescribed therapy in the US? Is Silymarin used in Europe by medical professionals or by holistic/naturalist health practitioners? My rough google skills seem to point to it being used primarily in a folk remedy capacity (but then my searches are English only - who knows what part of Europe they are talking about?).

The Mayo Clinic's take on Milk Thistle Extract (legalon)

There is no such thing as a harmless medication. As mentioned it displaces other treatment options. Further, it costs money and there are limited financial resources in the medicine funding world. If your insurance company is forking out $$$ for an unproven therapy then that is less money that company will have available for effective therapy for other patients.

Not only that but there can be horrific consequences to using untested medicines as the recent English drug trial disaster highlighted.

Note that the red tape took DAYS to cut through, most of it a result of the lack of FDA approval of this drug.

Right. Because if the FDA got out of the way then there would be strategically located warehouses filled with unproven medical treatments that won't result in hospital bed and ambulance shortages or courier delays.

I think if you really want to complain about something it should be timezones. If people were all on the same clock they would received treatment a lot sooner

Now, that's great, but when I find something on google and take it to a physician, I get laughed at... Miracles must go with medical titles, apparently.

Google Scholar Laotic. It indexes the scientific research that Doc's are supposed to based their decisions on. Very different from straight Google.
posted by srboisvert at 5:32 AM on January 15, 2007

who knows what part of Europe they are talking about?

From the article:
"Very early Wednesday morning, Mitchell called the company and got the number of its office in Germany, where the drug [Legalon-Sil, milk thistle extract in an intravenous form] is approved for use."
I don't know how many holistic healers prescribe IV drugs in Germany, but I'm guessing not many.

Right. Because if the FDA got out of the way then there would be strategically located warehouses filled with unproven medical treatments that won't result in hospital bed and ambulance shortages or courier delays

Maybe if the FDA got out of the way that drug would be available in California, where the majority of these cases arise. I can't believe I had to spell out that oh-so-complex leap of logic....
posted by eparchos at 5:39 AM on January 15, 2007

Apparently European scientists and 20 years of use in medicine in Europe is not enough for the FDA.

Thalidomide.

After that the rule in the FDA (and, to be fair, in almost every European Country as well) is that you do the studies first, and you do them at home.

It's a damned if you do, damned if you don't. If the FDA approves to quickly, we get Thalidomide II and Vioxx. If they don't, we get AIDS patients screaming and people dying.

It reminds me of the baseball umpire's lament -- "We are expected to be perfect at the start of the season, and improve as the season progresses."

And, news flash -- the FDA didn't wait days. The approval came very quickly:

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?'

Both the Dominican Hospital board and the FDA reacted very quickly -- once shown that the patients were willing, that there was no conventional therapy available, and that there was evidence that the patients had received a fatal dose, the approval came probably as fast as it possibly could.

They were admitted on January 2nd. The diagnosis came late that day. January 2nd is a Tuesday. The docs called Germany very late Tuesday. The US office called back with the FDA warning Wednesday morning. That's when the approval process started -- and it was finished by Wednesday afternoon. Then they got hung by the timezone difference -- 5PM EST is 10PM GMT, 11PM CET, and they'd missed the FedEx cutoff. They went to a courier on next-flight-out, but that took time as well. An early morning Europe-US flight will arrive mid to late morning the same day, then add on local transit time.

The two biggest delays was the three days between ingestion and arrival at the hospital, and the shipping delay.
posted by eriko at 5:42 AM on January 15, 2007

eriko
I'm aware of what all the delays were caused by, I read the article too. My POINT is that, if this drug were FDA approved, it would be in California instead of in a warehouse in New Jersey. Is this really that difficult to understand?
As far as "damned if you do, damned if you don't" goes, I think we can safely damn the FDA for many many things, mostly for being basically a "fast track the big money's dangerous stuff and screw the people" organization, rather than an agency which serves the people of the US.
posted by eparchos at 5:58 AM on January 15, 2007

Maybe it's just not a very engaging point compared to everyone else's.
posted by mendel at 6:18 AM on January 15, 2007

Maybe it's just not a very engaging point compared to everyone else's.

Maybe it's not, but it seems to have been missed an awful lot. Engaging or not, I'd say it's a rather simple one.
posted by eparchos at 6:35 AM on January 15, 2007

The reason this drug has not been approved by the FDA is because no big manufacturer has invested in the necessary studies. No IND application had been made up until this time. You can't fault the FDA for not granting an application that no one ever applied for.

It's a nice story, but it would have been better told if not for the obvious and (in this case unjustifiable) anti-FDA slant. Instead of "massive FDA red tape", you could have said something to the effect that concerned people at the FDA accelerated the usual procedures to secure the IND status for this drug. Because that is what happened. God forbid a government agency, even a deeply flawed one, should do something good.

You could also have mentioned that a multi-year study of milk thistle extract for the treatment of hepatitis is in its "early stages" - planning? enrollment? what? Why don't you give us some Background on US research on a New and Exciting Remedy that may or may not have Saved an Entire Family from Death? I know why - because you haven't the slightest idea about scientific research or medicine.
posted by Mister_A at 6:50 AM on January 15, 2007

That goes double for you eparchos. The FDA doesn't "approve" things for which no application has been made. Get it? And just to be clear - it is apparent that the compound we are discussing has received IND designation from the FDA. That means, basically, that it can be used in research settings; you can't get a prescription for it at this time.
posted by Mister_A at 6:54 AM on January 15, 2007

My POINT is that, if this drug were FDA approved, it would be in California instead of in a warehouse in New Jersey.

Yes, and that's a stupid point. What is the FDA supposed to do, in your opinion? Spend billions of dollars scouring the world for unapproved medicines and rushing them to market on the off chance that someday someone will need them in an emergency? You have no idea how the process works, you just want to complain about "red tape".
posted by dhartung at 7:03 AM on January 15, 2007

After reading the piece, my reaction to the FDA involvement is that there actually is at least one person working there that isn't a mindless, rule-bound government drone.

Miracle, indeed.
posted by Enron Hubbard at 7:13 AM on January 15, 2007

No, I do "get it", but the problem is as you said: "no big manufacturer has invested in the necessary studies."
I'm not faulting the FDA for not approving this drug, I'm pointing out that their lack of approval of a drug that has been in use in Europe for 20+ years made it very difficult for a doctor to get it to his patients.
I do have a pretty good idea about scientific research. What is going on here is not scientific research, it is bureaucratic supervision of scientific research.
I find it funny that you apply that "double to me" when your comment essentially reiterates in greater detail what I offhandedly mentioned earlier, and I quote:
"As far as "damned if you do, damned if you don't" goes, I think we can safely damn the FDA for many many things, mostly for being basically a "fast track the big money's dangerous stuff and screw the people" organization, rather than an agency which serves the people of the US."

What is the FDA supposed to do, in your opinion? Spend billions of dollars scouring the world for unapproved medicines and rushing them to market on the off chance that someday someone will need them in an emergency?

I would say that that is EXACTLY what the FDA should do, rather than spending billions of dollars approving unsafe pesticides before studies have been completed.

You have no idea how the process works, you just want to complain about "red tape""

No... if I had no idea how the process worked I would be in the "The FDA is fine! Hurrah!" camp.
Feel free to continue belittling my lack of knowledge, fellas, but watch out for the FDA! After all, they're not the greatest scientists around either....
posted by eparchos at 7:20 AM on January 15, 2007

Seems to me blaming FDA in this occasion is uncalled for. Yet I found it quite interesting to find out that the experimentation on milk thistle has just started in U.S.

Why so late ?

NIH, a federal agency and one of the world's foremost research centers, takes the position that there is not enough evidence that milk thistle has medical benefits. The agency says studies of oral milk thistle conducted outside the United States are flawed.

What if NIH is wrong ?

Then it occourred to me that, even considering my complete ignorance of many significant details, the absolute number of amanita poisoning in a year may be too low to command the interest of pharmaceutical companies , or more generally, interest of revenue or profit driven entities.

But what if their data is wrong, what if they revenue model is obsolete (see RIAA) , what if unrestricted irrational greed takes control of significant portions of research ?
posted by elpapacito at 7:59 AM on January 15, 2007

eparchos - the fact that a medication is used in Europe does not mean it is de facto "good", and should be approved by the FDA without the kind of intense scrutiny to which other medications are subjected. FDA has a responsibility to ensure that drugs sold here meet certain standards, and in many cases, European or Asian standards are different (not necessarily better or worse) than American standards.

As to your fast track charge, the FDA has not been approving many medications recently. This is probably because many applications are replacements for medicines that are coming off patent, and do not offer substantial advantages over existing treatments.

So you see, FDA is finally, belatedly tightening the reins a bit, and requiring applicants to demonstrate that their medications bring something new to the table. This comes in the aftermath of disasters like Baycol and the COX-2 inhibitors.

I have written here before about some of the problems with the current system of corporate-funded drug research, and I propose once again that the way forward is for our government to assume a greater role in medical research. Believe it or not, there are impartial scientists and physicians out there, but they are relegated to the sidelines if they criticize a company, study, or product too strenuously. You will not be asked to design and conduct a study of a new drug if you have loudly criticized other studies run by the sponsor. The answer, to me, is to make the US government (that's us) the sponsor of most drug research conducted in this country. That may sound like "bureaucratic supervision of scientific research" to you, but the alternative is to allow the pharmaceutical companies to continue their drug research oligopoly, to the great detriment of the national health.
posted by Mister_A at 8:11 AM on January 15, 2007

I started reading this story expecting to learn about something new for amanita phalloides poisoning. Instead I read that the FDA is once again obstructing a medicine that can be found in any vitamin shop, and is indeed only obstructing the IV form of the drug. (Many, many people know about milk thistle for liver repair, but not many doctors do, because doctors are not taught herbs in medical school!)

Anyone who's followed the contortions of the pharmaceutical profit-protection arm of the government (otherwise known as the FDA) let out a big bray of a laugh at the idea that there was some kind of "miracle" in this story.

Instead, it is a story of tradgedy. A tradgedy of the boneheaded, hidebound, ultra-ossified attitudes of the deadly FDA.
posted by telstar at 8:26 AM on January 15, 2007

Mister_A
I agree with you wholeheartedly. My main gripe with the FDA is that it has acted more in the interests of chemical and pharmaceutical companies, historically, than in the interests of people. If it's taking steps to change that, great, more power to them and I hope it works.
I'm not saying that the medication's use in Europe is de facto good, but I am canfused as to why the NIH thinks the European studies are flawed. I also think that 20 years of use of a medication should show some effect, positive or negative, which would certainly count as a viable study for most scientists, assuming the data was collected.
posted by eparchos at 8:31 AM on January 15, 2007

Wow, apparently this article is like one of those drawings where one group of people see one thing and another see something else.

Most annoying thing about the article: why in the hell does it make any difference whether the care givers have kids? Does having children suddenly make you a better person than someone without them?
posted by maxwelton at 8:37 AM on January 15, 2007

"Clinical efficacy of milk thistle is not clearly established. Interpretation of the evidence is hampered by poor study methods and/or poor quality of reporting in publications. Problems in study design include heterogeneity in etiology and extent of liver disease, small sample sizes, and variation in formulation, dosing, and duration of milk thistle therapy. Possible benefit has been shown most frequently, but not consistently, for improvement in aminotransferases and liver function tests are overwhelmingly the most common outcome measure studied. Survival and other clinical outcome measures have been studied least often, with both positive and negative findings."

Milk Thistle: Effects on Liver Disease and Cirrhosis and Clinical Adverse Effects -- from the AHRQ, a sister division of the FDA under HHS. The report also lists several specific suggestions for improving future trials.
posted by Nahum Tate at 8:39 AM on January 15, 2007

It might also be worth pointing out that even the treating physician is unsure whether the Legalon treatment had any effect. Only two patients received it and one died. Given that 8 of 17 severely ill patients survived at the experienced hospital without the drug the current story looks less like a new drug miracle and more like a baseline survival rate.
posted by srboisvert at 8:51 AM on January 15, 2007 [1 favorite]

I don't know about the FDA. Alls I know is:

This is a really silly post.

USE GOOGLE. THE LIFE YOU SAVE MAY BE YOUR OWN.
posted by koeselitz at 8:55 AM on January 15, 2007

well, salicylic acid was a folk remedy too. Milk thistle extract has a very long history in the countries I've lived in (all European) and I keep it in the medicine cabinet and take it regularly as I like a tipple now and again.
However it's true to say that we will probably never know if it was the activated charcol or the other medications acting in combination with it, or even if there was a significant placebo effect.
And we won't know until we do studies.
What was heartening was the response from medics, couriers and companies all over the world.
posted by Wilder at 8:59 AM on January 15, 2007

What is the FDA supposed to do, in your opinion? Spend billions of dollars scouring the world for unapproved medicines and rushing them to market on the off chance that someday someone will need them in an emergency?

I would say that that is EXACTLY what the FDA should do

I suppose this exchange says all that needs be said.

Look, eparchos, I can tell that you place a high value on Consistency in Questioning Authority, which includes, apparently, reflexive conclusions that any FDA action shows its slavery to corporate interests and all that. But I have no idea what you're advocating. That the FDA should automatically approve drugs approved in other countries? Or only Europe? Or only western Europe?

That drugs believed to be worthy by The People should be stocked in warehouses and -- what -- given automatic approval? And who are The People? Folk singers? Naturopaths? Some guy on a message board?

You apparently want no procedure, just whatever you want whenever it should be needed, wanted or suspected. And then, presumably, you'll stay true to your hardcore values and still bitch on internet forums about how the FDA is sold out to corporate interests.
posted by argybarg at 9:05 AM on January 15, 2007

argybarg

Yes, that exchange did say all that needed to be said: A straw man doesn't deserve an in-depth answer. But don't let me stop you!
posted by eparchos at 9:20 AM on January 15, 2007

"If it's God's will for them to recover, they will," he said. "If it's not, they won't."

And yet, the doctor collects his fee regardless.

Hooray for the people who recovered (although, really, eating wild mushrooms is like filing an application for the Darwin Awards), but I have to wonder about a doctor who takes such a (keyword) fatalistic approach to his profession.
posted by SPrintF at 9:27 AM on January 15, 2007

The FDA is hamstrung by lack of funding and now draws much of it from corporations through 'user fees' (which fund approval processes for their own pharmaceuticals). By the way, similar bias exists at the NIH, where many of the scientists have recently been found to be on the payroll of drug companies (but promise that their work is in no way biased). I'm not a big fan, like those above, of the process, but not because it's "government bureaucracy." We need more of it, in a sense; it's much more efficient. All of our greatest medical cures have come from public research.
posted by faux ami at 9:44 AM on January 15, 2007

Oh please can we have more government funded research. If there's one thing that should help medical research it has to be a good dose of politicization of the process.

Has anyone been paying attention to the government's or even the people's general response to most scientific research/findings lately?
posted by crashlanding at 12:28 PM on January 15, 2007

I'm not saying that the medication's use in Europe is de facto good, but I am canfused as to why the NIH thinks the European studies are flawed.

It's not that they assume the studies are flawed up front (though many times the EMEA and FDA are not entirely satisfied with studies which the other approved), but as has been noted here, without an application, why would they even look at the European studies?

Also, what fast tracked "dangerous stuff" can you cite that is making big money for the pharma sector? I've been involved in two "fast tracked" drugs in my 15 years in the industry. One for refractory melanoma (fast tracked because the current best treatment is, "get your affairs in order, you have a month or two"). The other for acromegaly, a disorder effecting ≈0.005% of the population . (And previously discussed here.)
posted by Kid Charlemagne at 6:05 PM on January 15, 2007

Actually, it seems to me that the FDA pretty much worked as fast as humanly possible to help save this family. I hardly think this is one of those times when we can burn the effigies. Granted, the FDA has done some stupid stuff in the past, and there are certainly accusations of methodology problems, but none of those have anything to do with this particular case.

That said; What Is With The Constant Capitals, BodyGuard? Your Post Isn't an Apple Product is It?
posted by dejah420 at 9:32 PM on January 15, 2007

In this case the FDA may not be quite the bogeyman the article tries to make them out to be. Nevertheless, it is very hard to argue that there is not a general and strong bias in favor of pharmaceuticals and against any form of natural remedy. For one the thing, the amounts of money involved almost guarantee unfairness (the drug companies don't get to charge dollars per pill for something that can be obtained naturally, get it). We've all heard of scientists and researchers severly penalized for daring to tell the truth about the ineffectiveness or danger of a drug that they are testing, so how does this lead to great confidence in the whole standard drug approval procedure? Another point is the many drugs that were approved and later found out to have severe side effects (do I even need to mention any examples?), but aside from a few attempts at scaremongering, natural remedies have never been shown to have anywhere near the side effects of drugs.
posted by blue shadows at 11:11 PM on January 15, 2007

They didn't mention how the death cap mushrooms tasted. Maybe if you eat them with a bottle of milk thistle, it's only as dangerous as eating fugu.
posted by stavrogin at 1:20 AM on January 16, 2007

Kid Charlemagne:

The stuff I was thinking of was a pesticide called Atrazine.
Apparently, despite tons of negative data on Atrazine, it's now being pushed as a cure for malaria.
Admittedly, this pesticide is being protected by the FDA and the EPA, but since we were discussing the FDA here, it sprung to mind.
posted by eparchos at 4:09 AM on January 16, 2007

...the drug companies don't get to charge dollars per pill for something that can be obtained naturally, get it.

No, the "herbal supplement" companies get to charge dollars per pill for something that can be obtained naturally, and they don't have to test it for safety first, so they get even more profit.
posted by hydropsyche at 6:32 AM on January 16, 2007

No, in most cases herbal supplements are much less expensive than prescription drugs. As for the safety tests, like I said there have not been any cases reported that I know where side effects of alternative medicine are even remotely comparable to that of the pharmaceutical disasters.
posted by blue shadows at 10:22 AM on January 16, 2007

Enron Hubbard writes "my reaction to the FDA involvement is that there actually is at least one person working there that isn't a mindless, rule-bound government drone."

Not uncommon, much of the civil service are enablers within the framework set out by legislation and resource allocation.
posted by Mitheral at 11:52 AM on January 16, 2007

Great, now can we talk about the real moral of the damn story? DON'T go eating wild mushrooms unless you know exactly what the hell they are!
posted by ilsa at 2:11 PM on January 16, 2007