As the resident “scientific advisor” here at ultimatefatburner.com, I occasionally get called on to comment on issues unrelated to my primary tasks (writing bodybuilding supp and functional food reviews; blogging).  Thus, it was no surprise to find an e-mail from Paul in this morning’s messages, asking for my feedback on an exchange he had with Dr. Ben Gonzalez, over his (negative) review on hCG for weight loss.

OMFG!

There’s a ton o’words hiding behind the above links.  Click on ‘em if you’d like the long version, but here’s the gist of it… Dr. Gonzalez owns/operates a wellness/anti-aging clinic: the Atlantis Medical Wellness Center in Washington, DC.  He uses the hCG Protocol – a rigid, 500 calorie diet in conjunction with hCG injections - in his practice, and feels that it has been outstandingly successful on the selected, obese patients (over 200 patients and counting) it’s been used on.  So he posted some (lengthy) comments over at Real-Customer-Comments.com to protest the negative tone of Paul’s review.

Now personally, I think Paul’s response to Dr. Gonzalez’s comments was spot on:

Our job is to look at the existing data, compare it to the claims, and report on the results. That’s exactly what we did here. Looking at the published data, how could you come to any other conclusion? As you say yourself, even the positive results you have obtained are anecdotal. In other words, even you have no real evidence.

Badda-bing, badda-boom.  Short. Sweet. To the point.  I honestly can’t improve on that.  The evidence shows that a highly restrictive diet + hCG is no better than the same diet + placebo.  This is precisely what Paul reported…and Dr. Gonzalez presented ZERO evidence to to the contrary.

So why am I piling on?  It’s pretty simple, really.  In his (very extensive) comments, Dr. Gonzalez makes certain points that virtually scream for rebuttal. The word of an MD carries a lot of weight with the general public, so the flaws in his argument(s) need to be addressed in more detail than Paul was able to provide in the hCG comment thread.

So let’s take Dr. Gonzalez’s points from the top…

1. I made the same mistake every other traditionally trained health professional does when looking at the protocol. I looked at it from a narrow minded view. “It’s not FDA approved, anyone can lose weight on 500 Kcalories a day, there are no studies proving it, you can’t live on 500 calories, anecdotal reports are worthless, etc.”

Sigh. The “narrow-minded, traditionally-trained expert” schtick is an old, overused rhetorical device exploited by virtually every “alternative health” provider on the face of the planet -  not to mention proponents of other pseudoscientific beliefs, like Creation Science.

It’s a straw man here, as it posits a false dichotomy between the clinical, “ivory tower” view of the researcher, and personal, “real world” experience - otherwise known as ”anecdotal evidence”.  But as cancer surgeon/researcher/skeptic/med-blogger ORAC points out:

In science- and evidence-based medicine, anecdotes are indeed the raw material from which we as medical scientists derive hypotheses, and “anecdotes” are published all the time in the medical literature. They’re called “case reports.” We do not dismiss them out of hand just because they are “anecdotes.” When appropriate, we dismiss “anecdotes” because frequently they are “testimonials” and not controlled observations or because anecdotes themselves, even when the observations are controlled, are often deceiving, which is why further study in the form of more controlled trials is always necessary before science-based medicine will accept a claim.  Anecdotes are not enough…

In science, there are hierarchies of evidence, thus, being “open-minded” does not require us to give all of them equal weight. Anecdotes are acceptable as evidence, although we are NOT going to rank them above controlled studies unless there is a compelling reason to do so.  In addition, as ORAC notes, there’s a difference between “anecdotes” and “testimonials”.  While Dr. Gonzalez claims to have anecdotal evidence that refutes the studies, he provides no details; nor does he link to any published case reports.  This places his “anecdotes” at the level of “testimonials”, which are scientifically worthless.

But I digress:  the process of enlightenment - as described by Dr. Gonzalez –  is completely compatible with “traditional training”.  It’s his reasoning and conclusions that are suspect.

This is highlighted by his story.  I gotta ask: why is it that skeptics are invariably accused of being “narrow-minded” for demanding good evidence, while proponents of questionable therapies applaud themselves for their “open-mindedness”?  As philosopher of science Phillip Kitcher points out in his book, Abusing Science:

Open-mindedness is not incompatible with having opinions…what is crucial to open-mindedness is the way in which opinions are held.

Bingo: a rational skeptic bases his or her opinion on the evidence, but will change it if solid reasons are offered - the essence of “open-mindedness”.  Many proponents, on the other hand, refuse to consider – or brush aside – evidence that contradicts what they want (or want others) to believe…which is pretty “narrow-minded”, if you ask me. 

Paul and I are rational skeptics.  As for Dr. Gonzalez…well, as you read what follows, you can decide for yourselves.

2. A myth concerning this protocol is that you live off 500 calories…

Well, I suppose Dr. Gonzalez is correct, if we parse the words “live off”…but the process he describes:

Actuality is that you live off the 500 calories you ingest PLUS the calories you burn from your fat…

…could be used to describe ANY weight loss diet.  If you take in less energy than your body requires to fuel its activities, then yes, it will tap into its stored energy to make up the difference.  This is no less true for a conventional, 1500 calorie diet than it is for an unconventional, 500 calorie one. 

Despite the dramatic “myth/fact” flourish, this strikes me as a pretty banal observation.

3. Another myth: Fat only stores fat soluble vitamins. Nope. Fat stores many other minerals and hormones and in fact, is part of the endocrine system in making certain hormones. So as you burn fat it releases nutrition that your body uses for metabolism.

I honestly don’t know how to evaluate this.  Beyond the rather dubious equation of “hormones” with “nutrition”, he also points out that adipose tissue contains some stored micronutrients – another perfectly unremarkable observation.  So what? 

As stated above, it’s well-established that stored body fat is a source of energy (or “nutrition” if you will).  Since VLCDs (very low calorie diets) are sanctioned by “traditional” medicine, I’m really at a loss to understand why he’s making this argument…even people who are fasting can persist for quite some time.  BFD.

This brings up a related point: what I find disturbing about Dr. Gonzalez’s recitation of these “myths”, is his failure to specify just who the hell believes them in the first place.  They don’t appear anywhere in Paul’s review.  Is he claiming that medical professionals are perpetuating these myths?  If so, then they might be worth refuting in his comments; otherwise this is a red herring.

4. Did you know the hCG hormone is similar to thyroid hormone and acts to stimulate the thyroid?

No, I did NOT know this at all, and still don’t.  hCG is a large-ish glycoprotein composed of 244 amino acids.  By contrast, thyroxine (T4) and triiodothyronine (T3) are very small molecules, synthesized from a single amino acid: l-tyrosine. They are completely and utterly dissimilar.

Ok, in fairness, what Dr. Gonzalez actually MEANT to write, was that there is some resemblance between hCG and TSH – thyroid stimulating hormone (they share a subunit).  Thyroid hormones are made by the thyroid.  That’s why they’re called thyroid hormones. Thyroid STIMULATING hormone, on the other hand, is made in the pituitary gland. It’s a small point, perhaps, but telling…the level of precision I’m describing should be as natural as breathing to a technically-trained person claiming expertise in such matters in a public venue.

Nonetheless, it is true that hCG can have mild, thyroid stimulating effects - at least in pregnant women.  Once again, this is a well-known medical fact.  But the key term here is “mild”.  While it’s possible this could provide some metabolic boost under conditions of reduced calorie intake, I haven’t seen any info on this.  Dr. Gonzalez, of course, is certainly in a position to make the relevant measurements on his patients – that way, he can back up statements like “I am willing to bet this is part of the reason why it works in this protocol” with actual data.

5. I find it interesting that the FDA will approve a procedure that has a 300 plus people a year death rate (gastric bypass) not to mention a very high co-morbidity (associated problems) rate and physicians who will approve of this procedure. Yet, place a “black box” on hCG saying no approval for weight loss when there has been ZERO noted issues in over 50 years in hCG use in weight loss.

Dr. Gonzalez is being rather disingenuous here.  For the record, I am not “for” gastric bypass surgery…quite the contrary.  I consider it a “when all else has really, really failed” approach. But I also can’t argue with the data: despite the very real risks Dr. Gonzalez describes, study after study documents significant metabolic improvements (example here). And many patients undergoing the surgery insist that – despite the hardships – they’d do it all over again.

So, at its most basic level, we need to look at costs vs. benefits. As much as I hate to admit it (and I do), we know bariatric surgery WORKS for the majority. This is an established, completely unambiguous fact. It sucks, but there you go.

Now hCG treatment is undoubtedly pretty safe…and I’m not inclined to argue with Dr. Gonzalez’s contention that it’s much safer than bariatric surgery.  But its effectiveness is precisely what we’re debating here – while the issue may be settled in Dr. Gonzalez’s mind, it isn’t out here in the real world I inhabit.  I could just as easily argue that - say – cha de bugre is perfectly safe as a treatment for obesity…I’ve used it myself and rather like it.  But in the absence of proof that it works BETTER THAN PLACEBO (more on this below), it’s preposterous to laud it as a superior alternative to bariatric surgery; or to twit the FDA (for all its faults) for placing a “black box” on it.

Sorry Doc, but the point of making an argument is to CONVINCE me.  You can’t assume the truth of your conclusion in the process of proving it.  You have to present me with evidence independent of your assumption, if you want me (or Paul) to credit your opinion on the matter.

6. The “extensive studies” that are cited on both sides of the argument are very small studies (Greenway, etc.) and old and are equivocal when they are all looked at together. No study follows up on long term weight loss.

“Small” and “old” are also red herring arguments.  Small and old don’t add up to “wrong”. 

In addition, a 1995 meta-analysis does not support Dr. Gonzalez’s contention that the results are “equivocal when they are all looked at together.”  Looking at all the studies together is what meta-analyses are designed to do, after all.  Needless to state, the conclusion of the meta-analysis isn’t “equivocal” – it’s flat-out negative.

We conclude that there is no scientific evidence that hCG is effective in the treatment of obesity; it does not bring about weight-loss or fat-redistribution, nor does it reduce hunger or induce a feeling of well-being.

If Dr. Gonzalez has a quarrel with the methods or conclusions of this paper, then he is should make his case in front of a jury of his peers. To reiterate an earlier point: case reports are a perfectly valid way to share ideas and observations with other doctors, with an eye towards changing the consensus opinion. Hell, even “letters to the editor” printed in a respected journal carry some weight with other professionals.

7.  Why don’t I do a large study? Because it costs money and I am unable to get a grant to do so. No pharmaceutical will give money for a large study again, because there is no money to be made.

Ummmm…sorry Doc, but I spent nearly 8 years living (and working) on the NIH (National Institutes of Health) dole.  That dawg don’t hunt.

Grants don’t grow on trees, nor are there various scientifically-inclined philanthropists walking around with sacks of money to hand over to earnest-minded, would-be researchers in the absence of detailed grant proposals. Needless to state, the proposal and budget COME FIRST.  To say he’s “unable to get a grant” implies he’s actually made the effort, yet  – once again – no evidence of this is offered.  Presumably, Dr. Gonzalez is aware that ”Big Pharma” isn’t the only potential source of funds…there’s the guvmint and private foundations to consider, too.  And surely he could locate various university or other institutional co-authors to lend some “establishment cred” to his proposal.  Either he has compelling data that will attract their interest or he doesn’t.

Yes, I’ll be the first to admit, putting together a serious, competitive grant proposal is one hell of a lot of work. It’s work that has to be done by SOMEONE, however, if Dr. Gonzalez is truly committed to establishing hCG therapy as a credible treatment for obesity. And, to be honest, it’s probably a better use of his time than duking it out with consumer advocates in the comments sections of public supplement review sites.

8. The hCG is not for everybody. It is not a “weight loss cure” and it must be physician directed and supervised. It cannot be applied to the general public as many diets are. A full health evaluation is imperative prior to beginning such a diet. I have saved many from gastric bypass, been able to get diabetics off their medications, get patients off blood pressure meds, antidepression meds, and cholesterol meds because of this protocol.

What the reader wading through the original comments may not see, is that Dr. Gonzalez continually blurs the distinction between ”hCG” and “hCG Protocol.”  What Paul’s review, AND the studies he cites are grappling with, is the effectiveness of hCG as an adjunct to what physicians and researchers refer to as a VLCD (very low calorie diet).  Bells and whistles in the original protocol aside, that’s what it boils down to.

The point Dr. Gonzalez appears unable (or unwilling) to confront, is that NO ONE – least of all me or Paul – is arguing that VLCDs are ineffective for weight loss.  What Dr. Gonzalez has failed to demonstrate, is that a VLCD program is more effective WITH hCG than without it.  The patient restrictions and corresponding benefits he mentions, for example, are NOT unique to hCG treatment at all.  Even small amounts of weight/fat loss can produce measureable benefits to health.  It’s great that some of his patients have been able to drop their meds…but this is not a unique or unexpected result.  It could happen to anyone losing a lot of weight, on any number of reasonable diets.

Once again, the key point of contention is whether hCG treatment is BETTER THAN PLACEBO for producing these benefits.  This is the thrust of Paul’s review.  Now, I have to give Paul 30 lashes with a wet noodle for failing to put this distinction between “hCG” and “hCG Protocol” front and center in his review.  Nonetheless, Dr. Gonzalez claims to have read the studies Paul links to, so he damn well knows what the real issue is here, even if it’s a little “fuzzy” for the average reader.

10. True balance needs to be impartial and truly objective. Your reviews seem skewed.Example of that is the persistent citation of Trudeau as a scam artist as a reason for hCG ineffectiveness in your reviews.

This one was picked up by Paul already, but I’ll put in my two cents in too.  There is no “persistent citation” of Kevin Trudeau in his review, nor does Paul even remotely imply that Trudeau’s lack of credibility is the reason hCG is ineffective.  Paul simply draws the connection between Trudeau’s book, and the upsurge in interest in the diet protocol in the led to his review. His conclusion is clearly based on the lack of scientific evidence – not on Kevin Trudeau’s status as a scam artist.

In the end, Dr. Gonzalez needs to make a case that the HCG protocol is a superior alternative to competing, conventional VLCD programs such as the RFO Program offered in places like the UCLA medical center.

Research results from the RFO program have been published in the medical literature and have documented weight loss ranging from 50 to 250 pounds, depending upon the patients’ initial weight. Eighty five percent of patients successfully achieved their weight loss goals, and three years later sixty percent of them had maintained all or most of their lost weight. Accompanying this weight loss, there were marked reductions in blood pressure, improvement of diabetes control, improvement of serum cholesterol and lipid levels, and greater psychological well-being.

Looks like the bar is set pretty high.  If Dr. Gonzalez can top that, I think both Paul and I would be delighted to change our (skeptical – not “narrow”) minds, and give hCG a “thumbs up” for weight loss.

But until better data shows up, the verdict stands…