Looks like Jasper fled the country so I have no idea what this means for current and potential future patients for helmithic therapy. I wonder to what extent the FDA was going to pursue persecution, but by his actions, I imagine things weren’t going to look good.
I wonder for myself, what posting an Incubation 101 would mean to me. It is just the sharing of information, and from what I understand, I believe my first amendment rights gurantee I can say what I want. I am not selling or distrubuting the organism, but are we legally allowed to be working with an infectious organism that is considered a menace to society? (Or used to be, but the research is still a hypothesis at this point.) Many of those in the Nottingham and recent celiac trial elected to continue hosting their hookworms, but they may be protected under the protocol of being in a scientific study. We are not.
Does anyone know what we are legally allowed to do here? This is such a grey area, I doubt there is a helminthic therapy lawyer out there who could advise us. The problem is, we need someone besides ourselves to be hosting the worms in case we lose them accidentally. So that would involve infecting someone, and among consenting adults, is that acceptable? We can do fecal transfusion enemas, so in essence, we’d be sharing potentially infectious organisms there, but a worm is a whole new thing, especially considering we could contaminate the garbage collector if we do something wrong, and needless to say, we have to be weary of where we leave our feces. Are chemical toilets adequate? We couldn’t camp and go to the bathroom in a hole in a warm, moist environment. Can anyone think of ways that we can protect ourselves and continue to experiment with this therapy? Should I be paranoid and take this site down?
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I’m not a lawyer and I’m not qualified to give legal advice, but it seems like the FDA are going after Jasper because he’s making big money on something that’s not legal to sell. I don’t think they’d bother with someone just sending out hookworms. If you want to cover your ass, always specify that hookworms are not for internal use. I seriously doubt there is a law against owning a few live hookworms if you want to study them, preserve them or whatever. I know there are several drugs that are illegal to take, but can be prepared and sold for “research” purposes. So as long as you aren’t sending people hookworms to actually infect themselves, it’s probably fine.
I have some experience of contract law and I agree with David. You can send out the worms to whoever you like. AIT’s contract is null and void and they could now never serve papers on you in the US or ever hope to enforce anything other than a supply of goods type contract i.e once you buy the worms, you can do whatever you want with them.
I would be a bit careful about describing the provision of worms to others – you may get raided and your house turned over…
Did you sign a contract with Autoimmune Therapies saying you wouldn’t divulge “trade secrets”? If you did, I would be more concerned about violating that than saying anything that might upset the FDA. Of all the crap that’s available on the internet, I doubt one person discussing a hypothesis would cause the FDA to spend time and money to shut you down.
Personally, I hope the FDA finds my blog and comes knocking on my door…so I can punch them in the face.
Well,
The assumption that the worms change things inside our body as a drug is maybe correct.
However if you take yogurt or probiotics so does they ! yet they are classed as a supplement….??
Where do you draw the line.
Are they going to make kissing illegal so as to stop the intentional passing on of Epstein Barr Virus ?
Over 90% of people have had EBV by Adulthood yet kissing is still legal !
Are they going to jail children who go to school and pass on chicken pox or other bugs to their friends.
And yes Kids do get worms from school!
Here is something I don’t understand. Leeches and maggots are approved by the FDA as “medical devices”, the same as stents, prosthetics, and pacemakers.
http://www.usatoday.com/news/health/2004-07-07-leeches-maggots_x.htm
Presumedly because they can be grown in sterile conditions, unlike hookworms. But it’s a stretch to say these creatures are “devices” as it is a stretch to say hookworms are drugs. What is TSO classified as?
You might be interested to know that last night’s episode of House featured Chrons and a gentleman given helmiths.
That USA today article was fascinating.
I’m super busy at the moment, but will try to research the ‘non-profit Biotherapeutics Education and Research Foundation.’ They may be exactly who we need for this.
I’m very grateful to Jasper Lawrence for his research, but there are some things you simply can’t, or shouldn’t try to turn into a money-making business. This is one of them.
Here’s a recap of the House episode:
http://housewiki.fox.com/page/Teamwork+Recap
On Hulu, there’s an 8 day delay, so it’ll be available November 24th or so:
http://www.hulu.com/house
The more mainstream this stuff gets, the better. My girlfriend’s sister has MS, and she thinks I’m nuts for suggesting this could halt the degeneration.
Okay, the non-profit Biotherapeutics Education and Research Foundation looks perfect for those wanting hookworms:
http://www.bterfoundation.org/indexfiles/helminthrx.htm
They are up on Helminthic therapy, they are low cost, they have their own labs (Monarch Labs with their own website) which provide medical grade leeches and maggots, and they seem tailor made for our needs.
I think perhaps we may be looking at this wrong. Having the FDA classify hookworms as medical devices may be the key to getting our doctors able to prescribe them, and even letting us provide the supply:
“As the demand grows, Dr. Sherman said, it is likely that other players will enter the marketplace, so “the FDA has good reason to formalize things.”
Oddly, even though leeches and maggots are living creatures, it’s the FDA’s device division – responsible for such things as stents and pacemakers – that is undertaking the review.
The agency decided that maggots and leeches are devices, mainly because of how they perform their medical chores. Maggots chew dead flesh and leeches eat blood. “Those are mechanical processes,” Mark Melkerson, acting director of the FDA’s Division of General, Restorative and Neurological Devices, told reporters.
Currently, both leeches and maggots are regulated as unclassified devices. The agency is proposing that both maggots and leeches be classified as class II medical devices, subject to some safety requirements, but not as stringently regulated as class III devices, such as implantable pacemakers.
One requirement, already in place, is that both maggots and leeches be what is called “germ-free,” Dr. Sherman said. “They’re living creatures,” he said, “so they can’t be sterile.”
http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/1618
Okay, I wrote an email to Dr. Sherman at Biotherapeutics. Here it is (I didn’t mention this blog):
——–
Dear Dr. Sherman
I was delighted to read about your non-profit Biotherapeutics Foundation in a USA today article from 2004. When I found your website, I was equally pleased to see that you believe Helminthic therapy falls under the purview of your commitment to symbiotic medicine: “The BTER Foundation is …committed to improving the access to — and the quality of — maggot therapy, leech therapy, and the many other biotherapeutic modalities.”"
As you provide a link to the Yahoo Helminthic Therapy Forum, you are most likely aware of Jasper Lawrence and his efforts to sell hookworm larvae through his company Autoimmune Therapies. He provided what seemed to be a well organized service, but charged between 3-5000 dollars for that service. Now, it appears the FDA has shut down his company and he has left the country. While he gives the impression he will try to continue his business via mail from outside the country, and his former partner is using the same business model from a clinic in Tijuana, there is a growing list of people interested in getting access to these worms at (much) more reasonable cost. Even learning how to incubate hookworm eggs, and sharing them with any who want them. A do-it-yourself movement where people can choose to carry these symbionts and, should they need to, terminate them at will.
We could use your advice, and help. Ideally, you would be in a position to order some of these helminths, incubate them, and provide them at cost to the small numbers of people who want them.
There are a number of urgent questions you are uniquely qualified to answer, and please be assured I am aware that of all the limitations on your giving legal counsel. This is most informal, and more a request for current facts than practical legal advice. Please, your thoughts on these would be invaluable:
-If Mr. Lawrence infected people with hookworm larvae and charged a fee for the service, and also insisted that his clients sign extensive waivers promising not to share eggs or larvae, or the techniques used to transmit them, do you think such a contract would hold any validity under U.S. law? Are you aware of any laws that would restrict you from doing the same thing with maggot / leech therapy?
-If the FDA classifies hookworms as a ‘medical device,’ would that invalidate any claim Mr. Lawrence would have as to their use? I would imagine it would.
-Is there any chance your foundation would be able to provide access to hookworm larvae that would not cost thousands of dollars? There is a demand, a proven track record and research, and a vacuum on the supply side.
-If your foundation were able to provide such a service, would you do it directly, or would you need to go through a client’s doctor?
-Would those interested clients be able to find local doctors willing to use Helminthic techniques?
-The Monarch labs website states that “In the United States, Medical Maggots are regulated by the Food and Drug Administration as a prescription only medical device used in the care and treatment of wounds.” Do you know whether hookworms have yet been classified in the same way? (there seems to be some indication they have just made this ruling in their investigation into Mr. Lawrence’s company). Can you make inquiries and find out? Would you be willing to? There are a large number of people interested in the hookworm’s current legal status. Your help in finding this information would be much appreciated.
-Do you know whether FDA classification of a ‘prescription only medical device’ must go through the same rigor testing as drugs, i.e. three stages of clinical trials? Or can they just rule that hookworms can be classified as a medical device? If so, who in the FDA could I contact to request such a ruling? Is letting the FDA hear from those who want a certain ruling worthwhile, in your opinion?
-If the FDA made such a ruling, would you then be in a position to provide guidance to a primary care doctor in applying the larvae? If a patient had access to larvae, and a willing primary care physician, this would be a valid medical procedure under the law, correct?
I am most grateful for your time, and would appreciate any additional thoughts you may have on the matter. My allergies are a thorough nuisance, and my low energy levels make me feel older than my age. And I am much, much better off than many who are very interested in trying this therapy. And there is little risk as the worms can basically be killed with a single pill, if I understand this correctly.
Thanks again,
Ian MacLean
415 921.6771
This is an outstanding letter. I only hope he responds.
However, TSO (trichuris suis ova) is classified as an experimental drug, and has recently been blocked by the FDA again, even though they have IND status (investigative new drug) status for the U. of Wisconsis MS trial currently ongoing.
http://www.accessdata.fda.gov/cms_ia/importalert_159.html
If a non-colonizing parasite’s ova that is made from sterile pigs at a reputable pharmaceutical company in Germany is repeatedly blocked by the FDA, hookworms don’t stand a chance. I highly doubt they will classify hookworms as “medical devices” such as leeches and maggots since they go inside the body permanently and there is such fear of the pig pathogen reaching maturity, hence the FDA ban. And leeches and maggots are grown under sterile conditions, only are placed on the skin for several days…a whole different thing, really.
What’s it going to take to turn the tide? I have no idea. But most likely huge studies, and a complete overhaul of modern medical thinking.
Please let us know if you learn anything.
How to grow hookworms: recreate the tropics in a bucket. The end.
Big money? It is very hard to read this given what I have done and experienced over the last few years and not be enraged. I left the US with a few thousand dollars, as in substantially fewer than ten. We have consistently adjusted our prices to suit those in need, and compared to any other therapy our prices are ridiculously cheap. Go and compute Remicade, the cheapest of the monoclonals, or TSO, over a five year period, which is the average someone with hookworm can expect benefit.
They classified it as a pharmaceutical. If you try to provide an unlicensed drug to others, or ship it across state lines, you will be joining me in the tropics quickly, whether you do it as a hippy or a filthy capitalist won’t matter. Do you think you could supply heroin for free?
Dr. Sherman is not going to put his career in jeopardy to play worms with you, as I was leaving I was able to contact someone who had been through something similar fifteen years earlier. The FDA stripped the medical license of every doctor who had worked with him, pursued him in court for ten years at a cost of over half a million to him, and ruined his ability to find employment at the level he is qualified for ever since. The difference between a device and a drug are profound.
There is also the issue of deliberately infecting another with a disease, another angle to this that seems to have escaped everyone’s attention. Go look up the laws governing deliberately infecting another person with anything.
Get real.
As to the contract, think of a software EULA, but even were it not enforceable how about some common decency, “hey thanks Jasper for fucking your life up to make me well”, would suggest you adhere to it, having signed it and accepted it. A contract is a promise, an agreement. We don’t get to void them just because it is possible, if you have any sense of right and wrong. Just because a contract is no longer enforceable, not entirely clear here, does not mean honor counts for nothing. Or doesn’t it?
Especially since we are an ongoing and viable entity.
If you want to ruin your lives by making worms available for free grow some balls and go to the tropics and get them yourself.
At least you have confirmed me in thinking that America and its citizens have so profoundly lost their way that even were return possible I would not want it.
Thank you for that.
Jasper
I wasn’t criticizing you for making a buck Jasper – I have a job too and like you, spend a good deal of my life gathering little green pieces of paper to exchange for goods and services. I was simply stating that I think the FDA was pursuing you for providing an unapproved medical service FOR A FEE, something I still feel. It’s sad how poorly things have gone for you, but you aren’t the only one on this board with terrible troubles. Don’t get so haughty and self-righteous with a bunch of very sick people trying to ensure a continuous supply of their medication. I know that you’re trying to ensure the continuance of what is a near monopoly by artificially preserving scarcity, but even when your monopoly is broken you offer monotoring and medical oversight, services a free exchange program wouldn’t and which will ensure that your business remains competitive. I haven’t signed anything with you, but it does strike me as a bit absurd that your contract forever restricts what your patients can and can’t do with their own poop. I think you can continue to make a living without that.
Mr Lawrence, I welcome your right to reply. I feel some sympathy for your recent plight but it is the corollary of a gamble you took to provide hookworm and whipworm organisms internationally and by delivery from a United States address. If you had remained in Mexico as your former partner has then you would not have faced FDA legislature.
The reasons why you chose to base your therapy in California are apparently stated as a desire to widen the availability of the organisms to a greater clientele. It would be disingenuous to claim this was purely altruistic and deny the predominant financial and commercial focus of your company. You were in business to solely benefit from a naturally occurring organism that has evolved over millions of years and you should be aware that you cannot own the proprietary rights to a species – unless you uniquely bred it.
Helminthic therapy transcends the scope of your company and the landscape is changing fast. There will no doubt be an underground movement which distributes the worms and unlike narcotic drugs, there will be little harm from their administration. We will further discuss this here.
Good luck to you.
Let me know when you get your site up.
And for the record our contract allows our clients to reinfect themselves and their nuclear family.
I’ve already expressed my gratitude and thanks to Mr. Lawrence, and don’t blame him much for being bitter.
But many of us have no information about ‘adjusted’ prices, and can only go on fee structures that are known to be beyond the means of someone already spending similar amounts for annual health insurance which doesn’t cover these treatments. I, at least, simply can’t afford it.
Common sense also has a hard time reconciling medical taxonomy. It’s a friggin worm, not a disease, we evolved with it, and it can be killed with a pill. If our government wants to call it a ‘drug,’ or a ‘device,’ and limit its availability to us while taking millions from corporate lobbyists, then they’re going to have people going around them.
And if Mr. Lawrence tries to use their techniques, he’s going to find people going around him. The EULA is a good example. An agreement which can be so absurd in its violation of common sense and fairness it’s not enforceable in many of the courts in the U.S.
That’s a good thing. So the U.S. system has its corruptions, but also some protections left. It’s not black and white. Neither are people who want to share helminth eggs, even if they’re American.
Americans are good at creating DIY (do it yourself) movements to help each other out. Be it grocery cooperatives or open software movements. Crying that one’s business is suffering when it had no valid claim on a particular process, vegetable, or worm isn’t going to gain a lot of sympathy. In this country or out of it.
Good luck to you.
I also had another thought, but haven’t researched it yet: How about the Christian Scientists? If its relatively easy to identify hookworm eggs under a microscope, it seems like a Christian Scientist (from a multi-generation family of that faith) might be perfectly willing to perform the charitable act of sharing his poop with a movement that may validate his religious beliefs. Such an act might even fall under the umbrella of ‘freedom of religion.’ I’ll think more about this.
It’s been some time since anyone has written on this particular blog but I was wondering where are people getting their worms since they are no longer available through AIT?
Contact AIT to check their status. You can also go through wormtherapy.com but you need to travel to Tijuana and they only have hookworms (and tapeworms, but you don’t want those). Check the “worms” link on this site for more info. I believe there is still a company in Spain, and currently an MS trial at U. of Wisconsin with pig whipworms.
You can also buy pig whipworms (trichuris suis) from ovamed.org
Thank you for the information. You were lucky to get the worms from AIT before there were problems. I went on their site and it looks like eveything is “as usual” and nothing had occurred……so I wasn’t sure if they were still in business. By the way….how many worms do you have right now? I see you do an egg count every so often but was wondering how many you actual had helping you?
AIT is still in business. Contact them to see what they are doing now re. availability.
I did 10 worms last February, then added 10 more late September. So 20 total.
We know that hookworm eggs need approximately 7-10 days in the right conditions to develop to rhabditiform (L3) larvae. The right conditions are +60% humidity and a temperature between 25-35 degrees. I think Jasper was right when he said cultivating larvae is a bit like brewing beer.
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