Comparing of EMPowerplus and psychiatric drug side effects

As a Harvard Medical School psychopharmacologist, Dr. Charles Popper has used both psychiatric drugs and EMPowerplus extensively in his clinical practice. In the following excerpt from Dr. Popper’s expert testimony in Truehope’s 2006 court win over Health Canada, he compares the relative side effects of EMPowerplus and psychiatric drugs (see pages 1393–1394):

[p. 1393–1394]

Defense lawyer: Can you tell us roughly how many of your patients have chosen to try [EMPowerplus]?

Dr. Popper: I guess as an approximate number, I’d say 100. I haven’t actually kept count…but I would guess it would be in the range of 100 — maybe 150. And there have been a much larger number that I’ve consulted on that other doctors have treated, but that I have been advising them on. That might be another 300 or 500.

[p. 1412–1418]

Defense lawyer: What are the side effects that you see…if somebody is on EMPowerplus?

Dr. Popper: Initially, there, in some patients, is a softening of their stools. It’s not really diarrhea in most cases, but it’s really just a softer stool. Usually the stool remains formed…but it’s softer, and may be that way for a week or two weeks or a month, and then typically resolves and goes back to normal.

Some patients get some degree of nausea from taking so many pills at once, most likely, and usually that can be taken care of by having them take the EMPowerplus with food. It’s very similar to what we do with conventional psychiatric drugs that cause nausea. [If] they take the pills with food, that will typically reduce.

Occasionally there are headaches.

If they take the pills too late in the evening, some patients will get insomnia. The “B” vitamins are known to interfere with sleep in certain patients, and for that we just have them take the pills earlier in the day — have their last dose taken earlier in the day.

Some patients have noted, if their dose is a little too high, that they get something like agitated or anxious, and in those cases we just lower the dose. It means that the dose has been a little too high…in many of those cases, and that will resolve the problem. Of course, there are other cases where there are anxieties due to other things and not have to do with EMPowerplus, but that is a potential side effect if the dose is too high.

Occasionally the patient will have flatulence. That’s pretty unusual.

…[T]hose would be the clinical side effects. I might be leaving something out, but those are the typical ones…that I recall of knowing.

There are also some changes that we’ve noticed…in the laboratory work that we obtain on these patients. As a matter of routine, I ask all of my patients who are on EMPowerplus to get a pretty comprehensive series of blood tests, both before they start on EMPowerplus and then every six months during the time that they’re on EMPowerplus. It’s…a pretty extensive set, and that’s done because we don’t have controlled trials at this point to guide us on safety. So not really knowing what to look for, I’ve just been running a pretty comprehensive medical screen. I also have them get a physical exam every six months. I’ve been doing that, as I say, with all of my patients for some years now, and from those data we have had a couple of observations suggesting that EMPowerplus does have some effects.

The one is that it looks as if there is a very slight increase in blood sugar that I believe we’re seeing in the EMPowerplus patients. It’s a very small increase, probably averaging two or three units, which clinically, for most patients, would have no implications, and even for a diabetic patient, a change like that…would normally not require an adjustment in their insulin — in their diabetes medications. So it’s a very small change, but I believe it’s there.

The other thing that we’re picking up in the lab is a very slight degree of anticoagulation. So the blood clotting takes slightly longer… [T]he lengthening is about equivalent to what we might get if one were taking a baby aspirin for cardiac preventative purposes. So it’s again, a very small change — very slightly beyond the normal clotting parameter, normal limits of standard clotting, but in no way…the kind of clinical problem that one would really need to monitor or to be concerned about, even in a stroke patient.

Defense lawyer: So you’ve given us the side effect rundown for EMPowerplus, but generally speaking, what are typical side effects that one might encounter with other…medication treatments?

Dr. Popper: That is a huge field. Of course, it depends on the medication and the dosage and the individual.

But say, for the typical anti-mania treatments, the kinds of things that we typically expect would be clinically significant weight gain, on the order of five to ten pounds — up to 40 pounds at times, but five to ten would be fairly routine. That results in an increase in diabetes.

There are for Lithium…anti-thyroid effects that we need to sometimes supplement with thyroid hormones. Acne, skin changes. Kidney changes are a particular concern, especially in the long run; there are data suggesting that long-term treatment with Lithium can have potentially permanent effects on the efficiency of kidney functioning.

With a drug like Valproate, there’s a huge weight gain. …[T]here are an increase in androgens that can effect the development of children, or in adult women can induce polycystic ovary syndrome. Seizures can be induced.

The antidepressants — there are…typically not the occasional problems we see with EMPowerplus, but typically problems with insomnia, anxiety, headaches, nausea. A major effect on sexual energy and functioning. With Lamictal, one of the new popular treatments, there are — is a rare but potentially lethal skin reaction that can occur. So it’s…just a totally different kind of picture, in contrast to EMPowerplus where, you know, the symptoms I mentioned are basically either a nuisance, minor, symptoms…that barely need any ongoing management, or just clinically insignificant changes. So…it’s extremely different.

It takes…much more physician time and healthcare costs to manage conventional psychiatric medications… When I began using EMPowerplus, before that point I had, you know, a very full busy clinical practice — no free hours, everything was filled, long waiting lists. After several months of working with EMPowerplus, I had this huge number of patients that had required weekly or alternate week management that I was now seeing once every month or three months or six months, and for the first time in over 20 years, I actually had occasional free hours during the day. That had literally never happened, so the level of management that’s required…you know, I could do things that I just couldn’t do before. So it’s a completely different type of management.

Defense lawyer: So you’re talking about some patients you would have to see weekly. Why would that be?

Dr. Popper: Either to manage their residual psychiatric symptoms — the symptoms that the conventional drugs helped but didn’t help enough. So…their mania or their depression might be 60 percent better, or 80 percent better, but they were still having trouble, and so we would work to manage, to try to keep those symptoms minimized. Or they were having side effects of their psychiatric drugs that would need management.

…[C]ertain patients you can put…on a regimen and they’re okay, and you can follow them once a month, but not less. But many of the patients, especially the type that I see, require much more fine management, because they’re so treatment-resistant, because of the referral network that I have.

Defense lawyer: …[B]asically, you get the hard cases that other psychiatrists have difficulty managing?

Dr. Popper: I’m getting treatment-resistant cases that have failed on other treatments, and so they…require much more intensive treatment than some patients, but those very patients, when on EMPowerplus…often do so much better that they require that much less clinical management time.

Defense lawyer: So…you’ve got more time now in your practice, because you’re not having to intensely manage. So what did you do? Did you start golfing or…

Dr. Popper: I really have to admit this. I started seeing more patients.

Defense lawyer: …[A]nd you weren’t able to do that before because all your time was being consumed?

Dr. Popper: Yeah, it was very hard. I mean, for years, it was very hard for me to see any new patients. I’d maybe see one or two new patients a year, myself, and I’d consult occasionally, briefly, but to actually take a new patient…as my own — one or two a year for some probably ten years running before that.

And that all changed. That completely changed.