Dr. Steven Smith and Loma Lux Products

A review of Loma Lux product advertising for the treatment of psoriasis.

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Steven A. Smith, M.D., is a dermatologist practicing in Tulsa, Oklahoma, who has created two “homeopathic” products for psoriasis: Loma Lux Psoriasis and Psorizide Ultra.[1] These products were divinely inspired (through his wife and his “prayer laboratory”), though Smith has since attempted to back them with decent science.[2] Unfortunately, the science falls far short of what would be expected from a mainstream drug, and Smith’s idea of homeopathy also falls short of what real homeopaths believe (see my main homeopathy page for some references on homeopathy and science).

I should say, before going into detail on Smith’s products, that I do not believe in the homeopathic method. However, I do believe that I understand it very well (perhaps, I dare say, better than Smith does, since he doesn’t claim any formal homeopathic training, either).

Ingredients


The ingredients of Loma Lux Psoriasis are:[3]

Kali Bromatum, 1X (Potassium Bromide)
Natrum Bromatum, 2X (Sodium Bromide)
Niccolum Sulphuricum, 3X (Nickel Sulfate)
Zincum Bromatum, 4X (Zinc Bromide)
Kali Sulphuricum, 3X (Potassium Sulfate)

According to another web site about Loma Lux Psoriasis[4], all of these ingredients have been “Proven” (in the homeopathic sense) for various symptoms of psoriasis. Itching, inflammation, proliferation, etc. The references on this other site are to two Materia Medicae published prior to 1930 and one out-of-print Medica with no date listed. The sodium bromide is a stretch, as it is supposedly proven for “the melancholy and depression that can accompany chronic disease” (and has the only reference to the out-of-print book, as well).

(One of the problems, you see, with calling homeopathy a “science,” as Smith does[5], is that it has rarely, if ever, changed during its 200-year history. That 70-year-old references are being used as sole evidence in this day-and-age of scientific breakthroughs is itself decent evidence that this “science” is quite stagnant. Mainstream sciences advance — even the Law of Gravity is being actively investigated and refined as I write. Homeopathic “Laws,” once postulated, don’t seem to change much at all.)

In the “prescription-only” Psorizide Ultra, we find:[6]

Kali Bromatum, 1X (Potassium Bromide)
Niccolum Sulphuricum, 1X (Nickel Sulfate)
Zincum Bromatum, 4X (Zinc Bromide)

Update, May 3, 2010: Psorizide Ultra appears to have been discontinued.

The sodium bromide (for “the melancholy and depression”) and the potassium sulfate (“for abundant scaling or desquamation of the skin and associated itching; listed for the treatment of psoriasis”) are both gone. And the only other change in ingredients is that the nickel sulphate has lost two of its dilutions, making it less potent. This is what Smith calls the prescription version? It’s both weaker and lacking in ingredients which would treat psoriasis, according to the references given. If anything, Loma Lux Psoriasis should be the “prescription” remedy, not this stuff.

It appears as though the FDA, however, shares Smith’s interpretation. A 1988 law codified which homeopathic remedies could be considered “over the counter,” and which ones “prescription” (by which the law means “available only from a qualified homeopathic practitioner,” not necessarily from a pharmacist or an M.D.). The dividing line is by dilutions, and dilutions with more of the substance (lower X or C numbers) are recognized by the FDA as being more likely to cause harm, thus they get the “prescription” label. High dilutions (especially those above 24X or 12C) are seen by scientific medicine as probably being harmless, so they are available OTC. This is counter to the counterintuitive laws of homeopathy, but it is science-based.

Smith’s Theories


Smith has a theory as to why these products should work for psoriasis. He appears to believe that psoriatics have some sort of innate nickel imbalance — that nickel isn’t being absorbed correctly, or that there’s a defect in a nickel-dependent metabolic process — and so the body is attempting to raise the serum nickel levels to make nickel more easily available.[2]

Smith’s basis for this theory appears to be little more than two studies which show that psoriatics have more nickel in their blood than do normal people. Smith’s own study of nickel levels in psoriatics[8,9] actually contradicts the findings of the 1934 study he claims was well done.[2] Smith found nickel in all of his healthy controls, while the 1934 researchers found it in only 6% of 300 normal people. Smith fails to even attempt to reconcile these differences in results.

Smith cites two other studies done on nickel levels in psoriasis, but dismisses them, in his study, as being contradictory to each other and having methodological and/or analytical problems, without going into detail. Smith’s own study contradicts one of them (which actually found lower-than-normal levels of nickel in psoriatics[7]).

Is elevated serum nickel, if it really exists in psoriatics, evidence that Smith’s theories are correct? Not really. Not on its own. Smith doesn’t appear to have any evidence of any mechanism in a human body through which his theories would function. All he offers is speculation — even in the conclusion of his article. Anyone can speculate: perhaps the higher nickel levels Smith found are actually due to an innate abnormality in psoriatic kidney function — we simply don’t excrete nickel as well as normal people. Sounds just as plausible as Smith’s ideas, given the evidence.

Even if the products work as Smith claims (and we’ll look at that in a moment), it doesn’t verify his nickel theories. There’s a lot more than just nickel in these products, and therefore more than just nickel floating around in the bloodstream. The implication is that the other molecules cannot possibly have any pharmacological effect, but Smith has no evidence of this — actually, he doesn’t even appear to have thought about it.

Clinical Trials


Smith has done a single published clinical trial on using nickel and bromine in the treatment of psoriasis.[10,11] It should be noted, right away, that he did not test Loma Lux Psoriasis or Psorizide Ultra in this trial — neither product uses nickel dibromide as its sole active ingredient.

The next biggest problem with this study is that of the scales used to measure response to the medication. The patients assessed their own change in symptoms using a 0-to-4 scale where 0 meant “worse” and 4 meant “improved markedly.” A “clinician” (I take this to mean Smith himself, although it could have been one of his business partners) also used that scale to assess improvement. For some reason, a “blinded independent phsyician” was given a scale of 1-to-7 on which to grade clinical before-and-after photographs of the patients (1 meant “markedly worse,” 7 meant “markedly improved”).

The intermediate numbers in these scales aren’t given. I would assume that the 7-point scale is “balanced,” where ascore of 4 meant “no change,” 3 and 5 meant “slightly” worse or better, respectively, and 2 and 6 meant “moderately” worse or better. But this is just a guess. On the 5-point scale, a score or 0 meant “worse.” With that wording, is seems reasonable to believe that there was only the one score for getting worse (no “slightly” or “markedly” worse scores, in other words). If true, it seems reasonable to think that a score of 1 meant “no change,” 2 meant “improved slightly” and 3 meant “improved moderately.” Again, these are just guesses.

(On May 7, 2001, a request for this information was sent through the Loma Lux Web site’s “Request Information” form. No response has been forthcoming as of November 27, 2002.)

The biggest problem with these scales is that they are small. There aren’t many choices available. Next, they aren’t absolute, they’re relative. “Improved markedly” only as compared to the “before” state. This makes it difficult to assess change over time. Also, they’re highly subjective. One person’s “marked” improvement may be another’s “moderate” improvement. A measurement system such as the Psoriasis Area and Severity Index, while it has its own problems, is a recognized and well-used system for determining psoriasis coverage and severity. The before and after PASI scores would then be compared to learn overall improvement (actually, Smith did use some form of PASI in a later study, but it is unpublished).

The really important part, though, is looking at the numbers. The average (mean) improvement during this trial appears to be quite slight. If, as I guess above, “no change” is a 1, and “slightly better” is a 2, the average score as determined by the patients themselves was a very slight 1.6, and the clinician’s assessment was only 1.3, or even less encouraging. Worst of all, the independent physician, who scored based on clinical photos, appears to say that there was, on average, no change at all while taking the nickel dibromide.

But that’s only half of the story. The independent physician, for example, said that while on placebo treatment (saltwater), the patients actually got worse. Very slightly, but worse nonetheless. The patients didn’t appear to think so, however. And, as should be expected if the study were not blinded, the researchers found the greatest difference between placebo and treatment groups — which leads me to wonder how good the blinding was, in reality. But even this difference appears, to me at least, to be fairly small for 12 weeks worth of treatment.

Compare this to the fact that in 2-week-long clinical trials of potent steroids, the numbers compared are often how many people cleared completely (which seems to top 60% fairly often). In other words, had potent steroids been tested using Smith’s scale, they probably would have averaged a score somewhere near 3.5 — and in just 2 weeks — compared to Smith’s 1.6 (at best) for nickel dibromide over 12 weeks.

The article on this study also talks about nickel absorbtion, and how people vary greatly in how much nickel gets into the bloodstream after ingestion. He claims, without showing the data, that the patients who absorbed more nickel did much better than those who absorbed less. That’s fine from a research point-of-view, but Smith is selling his products to all psoriatics. And how many of us actually know how well we abosrb nickel prior to spending our cash? Very few.

Smith himself makes mention of the “moderate” amount of help given by this treatment when discussing the use of other, concurrent medications along with Loma Lux products. Given the proven efficacy of steroids and other mainstream treatments, and Smith’s own background as a dermatologist, it’s not surprising he combines “normal” treatments with his own products, and finds the results even more satisfying. Does it say a lot for nickel and bromine? Not really. It says more about Smith’s expectations and the placebo effect.

Smith makes a big deal out of reminding us that this was a “pilot study,” or one which is at the very beginning of an investigation into whatever question it seeks to answer. However, he ignores his own conclusion, “further studies are needed…” when he uses this study to sell his products.

While he claims to have done a second study, it is unpublished and it seems as though people who are unwilling to give out a mailing address or fax number won’t get to see it. From what Smith says about it in his other writings, it appears to represent a step backwards in researching the question of whether or not nickel and bromine are effective psoriasis treatments. It was an unblinded, or “open,” study, which means it was less rigorous in terms of the controls used to keep researcher or patient bias from affecting the results. Having not read the study, I won’t comment on it further.

Overall, the preliminary (pilot) results appear to be that nickel and bromine, in a low dose, can help keep psoriasis from getting worse (when evaluated by an independent phsyician with no financial stake in the results). Does the one study support the use of either Loma Lux Psoriasis or Psorizide Ultra? No, because they don’t contain nickel dibromide, and I see little reason to believe that the different ingredients will behave in exactly the same ways in the body. To do so is simply naïve (for example, eating metallic sodium while inhaling chlorine gas would be a deadly substitute for eating table salt, even though table salt is made of sodium and chlorine).

The Psoriasis Diet


Smith also presents a “Free Psoriasis Diet,” which is little more than a list of foods high in nickel or bromine, along with a handful of other words of advice (such as “avoid aromatic seasonings”) which have little, if any, scientific support.[12] Diets for psoriasis are common, and come in all shapes and sizes. Few have any evidence backing them, and Smith’s should be counted among them.

Smith does provide a note on the diet page, though, that “diet is not the only answer.” This does make him different from many of the promoters of dietary advice. Even farther down the page, though, his suggestion to visit “CGS Enterprises,” a company which sells Loma Lux products, to gain more extensive “diet modification suggestions,” will probably just confuse people — I can’t imagine that the “Spot-Free Diet” and Smith’s own diet are compatible, or share even a shred of the same theoretical basis.

Fake Homeopathy?


Starting with the above, I believe it’s pretty clear that Loma Lux Psoriasis and Psorizide Ultra are not true homeopathic products. Again, for anyone not familiar with homeopathy and its claims, please refer to the links on my main Homeopathy page for more information.

First, true homeopathic remedies, as Hahnemann envisioned them, are tailored to the individual. Since not all psoriatics are the same, or present with the same symtpoms, creating a one-size-fits-all homeopathic remedy as Smith has done contradicts a very basic homeopathic principle. That thousands of other people sell one-size-fits-all homeopathic remedies is no excuse, as it simply means that none of them are selling true homeopathic remedies, either. No, to get a true homeopathic remedy, a patient must see a homeopath, and get a medicine that is “custom-made” for them.

Second, while these products provide nickel to patients with a possible overabundance of nickel, which might be indicated in a homeopathic sense (Law of Similars), Smith is not using nickel in such a way. His products contain nickel so that more nickel is in the blood of psoriasis patients, not so that the body will “heal itself” of its nickel problems. Smith is trying to reconcile a hypothetical “allopathic” disease condition (that the psoriatic body is trying to somehow increase its nickel levels) with a homeopathic view of disease, and fails.

Third, contrary to the Law of Infinitesimals of homeopathy, Smith is confident that the more nickel a psoriatic absorbs, the better it will treat psoriasis. Just look at the fact that the “prescription” Psorizide Ultra contains nickel sulfate at a 1X dilution, while the non-prescription LomaLux psoriasis has it at 3X. Look at the fact that Smith suggests a diet in which foods high in nickel are emphasized. From a homeopathic viewpoint, the non-prescription version is actually the more-potent one — if Smith were really creating a homeopathic remedy based on Nickel, his dilutions would probably be on the order of 30X or more.

(It’s also unclear if these products even go through the homeopathic “succussion” process while being diluted. If they aren’t succussed, they aren’t homeopathic.)

Most importantly, Smith himself said the following in his 1999 lecture to the General Session of the American College for Advancement in Medicine.[2] These statements follow his lament that the FDA would only allow for a four-week trial period in finding proper dosing for his nickel treatment, when he would have preferred twelve weeks:

…We had spent a lot of money at that point without any deep pocket type of financing. We had also spent a lot of time and still had a long way to go — maybe ten years and ten million dollars would be a conservative estimate. So we had our backs against the wall…

That’s when I discovered the homeopathic route! I’m a traditionally trained dermatologist and at the time knew practically nothing about homeopathy. I discovered that we could get the same doses of nickel from nickel sulfate which was formulary in the Homeopathic Pharmacopeia of United States (HPUS). We could get the bromide from potassium or/and sodium bromide to achieve the same dosages that we had been testing. These were FDA acceptable legal drug ingredients!

Suddenly, I was able to test many more psoriasis patients in a short period of time utilizing an open controlled format…

In short, it looks to me like Smith still has little knowledge of homeopathy, and is using a 1938 law mandating the FDA’s “acceptance” of homeopathic treatments (they’ve never been scientifically accepted, and the FDA would not say that they work) to get around the limits imposed upon him by the FDA and the amount of funding he had available. He is following neither the Law of Similars nor the Law of Infinitesimals. It is my opinion, therefore, that these two products are not homeopathic, but instead “allopathic” treatments dressed up to look homeopathic in order to avoid more-stringent testing laws which other drug manufacturers are required to follow. Smith appears to have stumbled across homeopathy, and decided to use it the way some people use tax loopholes.

A Third Product?


There is also mention of a third product, Psorizide Forte, which doesn’t appear to exist as of yet. This, we are told, is basically Psorizide Ultra with the addition of fumaric acid to it. Smith appears, with his comments about fumaric acid, to have as much understanding of it as he does of homeopathy — very little. It is, after all, only fumaric acid esters which have shown any pharmacological effects. As Smith knows, plain-old fumaric acid is a common food additive. If it worked for psoriasis, people could get clear skin simply by eating lots of Gummi Bears. This kind of mistaken thinking — that if one thing works, then a safer version of that thing should also work (fumaric acid esters, Dovonex, etc.) — runs rampant among non-scientists in the medical field, especially naturopaths.

November 27, 2002, Update: Perhaps I missed it the first time, but I just stumbled across the Psorizide Forte advertisement in the July, 2002, Psoriasis Resource from the National Psoriasis Foundation. In the ad, they say, “European Psoriasis Medicine Now FDA Accepted!” This one sentence is misleading in four ways:

· As noted above, fumaric acid (the new ingredient) has no known medicinal qualities, it is instead fumaric acid esters which are the “European Psoriasis Medicine,”

· Fumaric acid has been “FDA Accepted” for over 60 years (or shorter if it’s been in the Homeopathic Pharmcopeia of the United States for less time), and not in any sense just recently (“Now”),

· “Accepted” does not in any legal or medical way mean the same thing as “approved for the treatment of psoriasis,” because,

· Acceptance — as drugs — of all substances in the Homeopathic Pharmacopeia of the United States was forced upon the FDA over 60 years ago by Congressional legislation, and not due to scientific findings which showed them to be of value.

The ad is furthermore deceptive by claiming (in the fine print) that “The use of fumaric acid and its derivatives (esters) as a treatment for psoriasis is increasing worldwide.” This is only true, medically, of the esters, and not of fumaric acid by itself, except under similarly deceptive conditions. The ad continues by talking about “its” clinical pharmacology (meaning fumaric acid, which has no known pharmacological effects — it’s a food additive), and implying that fumaric acid has “Dose dependent inhibitory effects on keratinocyte proliferation,” which is completely false.

The active ingredients in Psorizide Forte are listed as “Fumaric Acid 1X, Potassium Bromide 1X, and Nickel Sulfate 1X.” In other words, the somewhat-dilute Zinc Bromide of Psorizide Ultra has been replaced by a “strong” fumaric acid (except it’s very weak, in homeopathic terms). Again, the only reason this stuff is “prescription only” is because the FDA doesn’t agree with homeopaths — fewer dilutions mean more of the substances: the FDA considers that to be “stronger,” while a true homeopath would consider it to be “weaker.” Prescription status is based on FDA rules, so this weak medication (if it were truly homeopathic) needs a prescription, while 30X (or 30C) flu treatments, which are much more powerful in the minds of homeopaths, do not.

A manufacturer of real fumaric-acid-ester drugs claims that fumaric acid itself isn’t even absorbed by the intestines, which throws the claims for Psorizide Forte into question even more.

Other Problems with Dr. Smith’s Claims


Dr. Smith has written quite a lot on psoriasis, nickel, and bromine. I’ve found plenty of contradictions and confusions, enough to deserve another entire web page of their own. At this time, I’ll just highlight a few things:

Smith claims that a Dr. Gerald Kruger is or was a “noted psoriasis researcher.”[2] Smith was encouraged by Kruger’s assessment of Smith’s first clinical trial. I cannot find a single published article relating to psoriasis by a Gerald Kruger in Medline at all. One would think that a prominent researcher would be widely published. Then again, Medline only goes back to 1965, so it’s possible Kruger published quite a bit 40-plus years ago.

Smith states, in many places, that because the levels of nickel or bromine used are low, there is “no risk of side effects.” As any good medical scientist will tell you, even sugar pills can have “side effects.” There is no such thing as a side-effect-free medicine. He also claims that nickel is not a carcinogen, while the Merck Manual states that it might be. Also note that the Merck Manual only mentions bromine in its list of poisons (saying, “see Chlorine”).

Smith says that most of the patients he’s treated with his products he also treated with conventional therapies such as topical agents, UV light, even methotrexate. His claims that the combinations work better than conventional treatments alone fall flat in face of the fact that he doesn’t provide any evidence of this. A study which shows that people treated with UVB and Loma Lux Psoriasis clear faster or remain clear longer than those treated with UVB alone would give these claims some substance. Otherwise, Smith can’t know for sure. Even psoriasis that’s been unresponsive to treatment can go into remission, spontaneously.

Smith’s has at least two patents (5,171,581 and5,433,954) on the use of nickel and bromine in psoriasis. In these patents, he talks about “psoriasis molecules,” which, while it is reminiscent of Deepak Chopra, appears to me to be nothing more than “patentese” for “some as-yet unknown molecule or other which causes psoriasis.” This makes the patent broader than it otherwise would be, and appears to conflict with his nickel theories. The patents also describe tests which appear to have been done by Smith on patients but are unpublished anywhere else, and Smith doesn’t even appear to talk about the results anymore. It’s also interesting to note that the first patent was filed about two years before he ran his first clinical trial.

October 27, 2003, Update: It has come to my attention that Dr. Smith has corrected an error on his site. According to the Internet Archive, sometime between July 19, 2001, and June 16, 2002, a correction was made to the spelling of Gerald Krueger’s name in Dr. Smith’s “ACAM Lecture” page. Dr. Krueger really is a “noted psoriasis researcher.” (Back in the summer of 2001, I made some attempts to contact Dr. Krueger about the possibility that Dr. Smith spelled his name wrong, but, getting no reply, forgot the matter until now.) Smith says,

I then asked Dr. Gerald Krueger at University of Utah, a noted psoriasis researcher, to review this study. He said this was the best evidence that we really had a new therapeutic agent showing a dose/response type of relationship.

When compared to “no evidence at all,” Dr. Smith’s studies are, indeed, the “best evidence of a new therapeutic agent.” I agree with that assessment, in that manner. I will not speculate about what Dr. Krueger may have meant.

I also note that along with fixing his spelling error, Dr. Smith has re-titled the page. Even though the page is still named “ACAM_Lecture,” What was this:

Lecture to General Session
American College for Advancement in Medicine (A.C.A.M.)
Fall Convention, October 1999
Steven A. Smith, M.D., F.A.C.P
Fellow American Academy of Dermatology

has become this:
Lecture to General Session
American Osteopathic College of Dermatology
Mid-Year Meeting, March 2002
Steven A. Smith, M.D., F.A.C.P
Fellow American Academy of Dermatology


Besides the addition and deletion of several adverbs (presumably for clarity), slight modification of dosing numbers, and the addition of some extra advertising hype for Psorizide Forte (“This medication [Psorizide Forte] is clearly more effective than PSORIZIDE ULTRA, plus it has no new side-effects.”), there is not much that has been substantially changed between the old version and the new. Dr. Smith’s “parting remarks” have been eliminated. The majority of patients now see only “moderate improvement after 1216 weeks of therapy,” instead of “moderate to marked improvement.” The largest change made has been this: in the old lecture, Dr. Smith said at one point,

Our prescription product, PSORIZIDE ULTRA, comes in 300 mg tablets. It is indicated for psoriasis vulgaris, including scalp, genital, nail or joint disease. Localized pustular psoriasis responds well. I have treated over 5,000 patients of all varieties.

The above is now missing. In a prior part of the lecture, however, the following has now been added:

I Have [sic] treated approximately 10,000 patients with these medications. All types and severities of psoriasis respond favorably — most with a moderate improvement. Patients like the way they feel. Symptoms improve first, then redness and thickness fade with central clearing later becoming evident.

That’s the biggest difference I was able to find, and that’s not much. No new clinical trials are discussed (to back up the assertion that Psorizide Forte is “clearly” better than his older product), no new basic research into psoriasis and nickel. Nothing new, really, but advertising.

Conclusion


It is important to remember, when reading the advertisments for Smith’s products, that the words “relief” and “effective” are actually relative terms when used medically, but are used in absolute ways in these ads. The people who write this stuff know, for example, that the published clinical trial showed only “moderate” success, yet the ad would lead one to believe that everyone can be clear of psoriasis using Loma Lux Psoriasis (in which case, why bother with Psorizide Ultra?). While it might be “effective,” it’s not very effective when compared to, say, a high-potency steroid or even coal tar. And when reading clinical trial results, it’s important to remember that the phrase “statistically significant” does not often mean “oh, wow, my skin is now perfect!”

If you want a homeopathic medicine for psoriasis, look elsewhere, since it’s clear that Dr. Smith doesn’t believe in or follow basic tenets of homeopathy. Or, if you want a non-homeopathic medicine for psoriasis, look elsewhere, since it’s also obvious that these products only offer a small amount of help, if any, and take upwards of three months to show that “moderate” effect.

Footnotes