Periodically, I get to feeling pretty angry about the lack of progress in helping those with autism. This time of year, approaching Alex’s birthday, is always particularly bad for me, especially as, just a few weeks later, I mark the anniversary of his diagnosis with autism. This March it will be 21 years that I have been “fighting the unbeatable foe” while bearing “with unbearable sorrow”[i]…as the song goes. In over 2 decades, so very little has changed. There are still no accepted treatments. We’ve been given nothing by the medical establishment except for anti-psychotics, and their host of horrendous side effects, to (sometimes, but far from always) mask the worst symptoms.
I suppose that is why the timing was good (or bad, depending on how you look at it) that I came across an article in a law journal about the FDA’s excessive regulation of helminths and fecal transplants: “Of Poops and Parasites: Unethical FDA Overregulation.”[ii] It really fed right into my already feisty mood. The article starts off saying exactly what I just said in the last 2 sentences of my first paragraph: “Thousands of Americans suffer from illnesses untreatable by presently available therapies.” And while unapproved treatments may exist and even be known to be efficacious, the FDA persists in making them unavailable (ex. clinical trials are not finished), leaving “no choice for the doctor, and no choice for the patient.”
The author presents helminthic therapy and fecal transplant as two prime examples of this excessive regulation. Both therapies have substantial scientific basis. And while we may not have the trials to definitely ascertain when they will be effective, the risks of both are very well documented…and very low. And yet, in spite of the fact that both therapies are unaltered natural products, with well-known risks, etc., the FDA made the decision at some point that both therapies were essentially “pharmaceutical,” making them unavailable to Americans. This, in turn, led desperate people to instead, undertake these therapies under far less ideal circumstances. In the case of helminths, for example, “domestic and supervised treatment has largely been replaced with foreign, and often unsupervised, treatment associated with medical tourism.”
The author concludes that the FDA’s regulation of these two therapies is wholly unethical, and provides excellent and substantial support for his argument: “As a result of these restrictions, the FDA violates a tenet central to medical ethics: first, do no harm. If the purpose of the FDA is truly to safeguard the safety of the American patient, it must live up to this standard and avoid this unethical overregulation of treatments…”
By the way, according to the paper[iii] published last year by Dr. William Parker and colleagues at Duke University, the vast majority of the 400 or so patients with autism improved with helminths. And just last week, researchers at Arizona State University released the preliminary results of a small trial they’d completed on fecal transplant on patients with autism: “Not only did they see an 80% improvement in gastrointestinal discomfort, but nearly 25% of autism patients saw an improvement in certain autism behaviors, including social and sleep habits.”[iv]
Completely coincidentally, a day after reading Mr. Young’s absolutely superb treatise, I came across a letter[v] sent to the journal Nature in 2013 by two scientists at UK Universities: “We contend that using a pseudo-pharmaceutical process to evaluate helminth therapeutics – which typically costs millions of dollars and takes more than a decade to pass through clinical trials – is not the only way.” After all, they point out, rightly or wrongly more and more people afflicted with chronic autoimmune diseases are seeking their own solutions or “face unpleasant palliative therapies, side effects and surgery.” They suggest then, using these patients, using their insights and evidence, to help develop protocols for the use of helminths.
Well…amen to that.
I will continue to live in hope that someday, somehow, helminths will be safely, cheaply and easily available to anyone who wants them.
[i] Wasserman, Dale, Darion, Joe, Leigh, Mitch. The Impossible Dream, from Man of LaMancha.
[ii] Young, KA. Of poops and parasites: unethical FDA overregulation. Food and Drug Law Journal. 2014;69(4):555-574.
[iii] Liu, J., Morey, R.A., Wilson, J.K. and Parker, W. Practices and outcomes of self-treatment with helminths based on physicians’ observations. Journal of Helminthology. 2016;:1–11.
[v] Flowers, S, Hopkins, M. Patients self-treat with parasitic worms. [Letter to the editor]. Science. 2013;493:163.