The one area of the web that has as many “self help” and “miracle solutions” newsletters (and marketing teasers) as personal finance is health — the investing newsletters promise eternal wealth, and the health newsletters promise eternal life (or something dang close). Readers ask us about the crazy marketing for these health newsletters all the time, so we’ve found someone who can help answer these questions. His name is Michael Jorrin, we’ll call him “Doc Gumshoe” and he’s a longtime medical writer who can help add a little skepticism and reality to the hype we all see every day. Here’s his first article for you, we’ll try to bring him back on a regular basis if and when there’s interest (so feel free to suggest other topics for the Doc in the comments section below). As with our other guest authors, Michael’s opinions and assertions are his own.
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What’s behind the deep dark plot to keep miracle cures concealed from the public?
We’ve all heard it before. And yet, the temptation to take a peek behind the kimono is hard to resist. Might there just be a grain of truth in this latest claim?
Here’s a web video ad from a newsletter called Logical Health Alternatives that comes close to dangling the promise of eternal life:
It starts with the headline “Poof! 20 million cancer cells gone!” And it goes on from there. The premise is that there is a natural cancer treatment that miraculously exterminates cancer cells by the millions – even billions – with no ill-effects to the patient. And, of course, the implication is that Big Pharma is doing its evil utmost to keep us from finding out about it, because if we knew about the wondrous effects of this natural cure, no one would spend a dime on Big Pharma’s ineffective and dangerous drugs.
The website describes a New York City physician, Dr Fred Pescatore, in glowing terms. Here’s what the spokesperson says:
“I’ve been working in the health publishing industry for nearly 20 years. And yet, never before have I encountered a physician making such breathtaking inroads in natural medicine.
“Exposing the REAL causes behind today’s deadliest threats. And delivering cures so shockingly easy—they boggle the mind! And put ‘modern’ medicine’s high-tech ‘wonder drugs’ to SHAME.
“His name is Fred Pescatore, M.D. Dr. Pescatore is a best-selling author, sought-after medical expert, and trusted physician to hundreds of patients (from around the world) who flock to his high-profile Manhattan clinic.”
The secret remedy that cures cancer and a lot of other diseases is called “Alpha G,” and, according to the website,
“It’s virtually unheard of here in the land of “cut, poison, and burn” cancer care.”
Behind the premise that Big Pharma is threatened by “natural” treatments is an assumption, shared by many, that there is a fundamental distinction between “natural” treatments and pharmaceutical drugs. Let me say, right off the bat, that whatever distinction there is, it’s exceedingly blurry. Many – maybe even most – drugs have origins in natural remedies. Take aspirin.
Aspirin: a Drug Originating in Tree Bark
Aspirin (acetylsalicylic acid) traces back its source to infusions made from the bark of the willow tree (Salix), which was used to treat aches and pains from the times of Hippocrates, in the fourth century BC. Willow bark was not without its ill effects, however, and practitioners looked around for substitutes that might work as well without the problems, including the bark and leaves of those pretty Spirea bushes. And in the 19th century, chemists found ways to compound the “natural” salicylic acid with other molecules to mitigate the harmful effects, and by the end of the 19th century they arrived at aspirin as we know it today. But it took a lot of tinkering.
Aspirin, some might say, is a miracle drug. It alleviates pain. It brings down fever. It reduces inflammation. And, perhaps most usefully, it inhibits the clumping together of blood platelets, even in very small doses. Because clots formed by blood platelets in small blood vessels in the brain are the cause of strokes, aspirin is a very effective guard against strokes.
But it’s not without its harmful effects. The same mechanism that inhibits platelet clumping can slow blood clotting in other parts of the body. Long-term, high dose aspirin is thought to be an important cause of bleeding in the intestinal tract. In that sense, aspirin is like every other drug. No drug (and no extract from tree bark or any other “natural” substance) is entirely without harmful effects. As the saying goes, “the poison is in the dose.” Too much of anything can be harmful, even deadly.
More Tree Bark Drugs
But let’s go back to drugs that have their origin in natural substances. Quinine was derived from the bark of the chinchona tree, and is effective as a treatment for malaria. Quite a lot of other drugs, such as the quinolones (which include such vital antibiotics as ciprofloxacin and the other floxacins) are molecules with structures similar to the quinine molecule.
One of the recent discoveries along that line was that a compound from the bark of the Pacific yew tree (Taxus brevifolin), called “taxol,” is effective in combating cancer. Cancer cells, like all cells, reproduce by mitosis, or splitting. The process by which they do so is complex, but it involves dividing some of the cancer cell’s crucial components, such as chromosomes and microtubules. A number of drugs can significantly inhibit the process. Taxol-based agents using this mechanism include paclitaxel (Taxol, Bristol Myers Squibb); docetaxel (Taxotere, Sanofi-Aventis), Abraxane (a newer formulation of paclitaxel from Celgene) and others. These agents are now synthesized and no longer require collecting huge amounts of yew bark, which is fortunate, since it was estimated that a single clinical trial might require harvesting hundreds of thousands of these trees.
So, Big Pharma, as well as Little Pharma and Tiny Pharma, are keenly aware of any clues that a “natural” substance might have disease-fighting capabilities. Their eyes are peeled and their noses are to the ground, because from those “natural” remedies might come pharmaceuticals from which they would make billions.
Here’s what the website says about “Alpha G.” I won’t paraphrase it, I’ll quote it directly. Here it is:
“Renowned medical experts spanning the globe have come to a shocking consensus… Alzheimer’s…diabetes…heart disease…impotence…and much more
are all symptoms of…
“The HIDDEN EPIDEMIC of the Baby Boomer Generation
“Researchers call it ‘the single most common thread to premature death’Are you getting our free Daily Update
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“And, astonishingly…no one’s talking about it
“But now you can turn the tide against this stealth killer— with a solution so STUNNINGLY SIMPLE it puts modern medicine to shame!
“High blood pressure…Elevated cholesterol…Problem blood sugar…Bone loss…Sexual dysfunction.
“I’ll bet you know someone taking prescriptions for all these conditions. Maybe you face the avalanche of pill bottles every time you open your own medicine cabinet.
“But let me fill you in on a secret Big Pharma is desperate to keep tightly under wraps…
“Every single one of these sinister syndromes can be tied back to ONE HIDDEN CAUSE.
“In fact, as you’re about to discover inside this exclusive expose…
“There’s almost NO disease or health worry that isn’t directly related to this SECRET HEALTH MINEFIELD
“And in just a moment I’ll tell you how you can get the inside scoop on the jaw-droppingly EASY cure to this hidden cause.
About Alpha G
Okay, so what exactly is Alpha G? It appears to be alpha lipoic acid. This nutritional supplement is widely marketed. However, if you check the on-line sources for Alpha G or alpha lipoic acid, you will not find the kind of claims quoted above – nothing about curing any of the diseases mentioned on the video presentation. Why not?
Because if the marketers of those vitamins and supplements made any health claims, they would run afoul of the FDA. The FDA keeps a sharp eye on health claims of any kind, and especially on claims that a supplement or “nutraceutical” can cure or alleviate a disease. Claims of that kind have to be substantiated by evidence, and for lots and lots of supplements, that requirement is highly inconvenient, because there just isn’t any evidence. So the manufacturers and marketers of these supplements stay away from that dangerous ground. Which means that the claims have to be made by somebody else.
Is it really the case that establishment medicine doesn’t know anything about Alpha G, or is keeping it under wraps lest the availability of this miracle product utterly destroy the health-care establishment as we know it? Hardly. As it happens, if you go to PubMed, which is the website of the National Center for Biotechnology Information, part of the National Institutes of Health (NIH), and do a quick search for published studies on alpha lipoic acid, you will turn up 3,532 citations. Most of them, as far as I could tell, were studies in animals (mice, rats, guinea pigs, ferrets) or laboratory studies (in vitro, as they are called). No randomized controlled clinical trials in human beings have yet been published to confirm that alpha lipoic acid actually has any health benefits, or, perhaps more important at this stage, to determine whether alpha lipoic acid has any harmful effects, and if so, at what dose.
However, if we search the NIH website that lists clinical trials, whether completed, ongoing, recruiting, or terminated, we find 70 for alpha lipoic acid. Most of them are in combination with other drugs, and a few are federally-funded (one by the National Institute of Aging). The diseases in which alpha lipoic acid is being investigated include heart and vascular disease, diabetes, HIV, multiple sclerosis, and Alzheimer’s disease.
Alpha lipoic acid is an antioxidant, synthesized in our bodies, although in relatively small quantities. Like many organic molecules, it exists in two forms – the so-called right and left enantiomers. What does this mean? Complex organic molecules consist of several sub-units linked together. Molecules that are mirror images of each other can have the identical chemical composition, but function differently because of their shape. Think of the way a key fits into a lock – the exact mirror image of the key wouldn’t work at all, even though the profiles of the keys were identical. It’s the same thing with molecules. They work by fitting precisely into receptors, and if the right enantiomer is the one that fits, the left enantiomer is basically useless. For alpha lipoic acid, it’s the right enantiomer that has the antioxidant characteristics, but most manufactured alpha lipoic acid supplements are half and half right and left. It’s very difficult to separate the two forms, and nobody is quite sure what the left enantiomer does.
What we can be entirely sure of is that the health-care establishment and the pharmaceutical companies are watching alpha lipoic acid carefully. They are not bent on keeping it a secret or concealing its benefits, whatever those might turn out to be, from the public.
The Other Two Miracle Drugs
So, what are Dr Fred’s other two miracle cures? He calls the second one his “Secret Super Charger,” (SSC) and here’s what that presentation says about it:
“SSC is a secret ingredient–a delicious natural, ultra-healthy, relatively inexpensive plant extract with near-magical health-promoting powers. The plant is native to Australia, and ‘freakish’ is truly the word for it…
“It goes to work melting that stubborn belly bulge and balancing see-sawing blood sugar in a matter of DAYS.
“How does it work? Well, SSC blows away any other superfood you may have sampled in its enormous proportion of monounsaturates. These are the ‘good fats’ that help make olive oil so sensational, and SSC is nature’s richest source of them bar none…”
According to the presentation, the result is a cure for diabetes …
“A cure so powerful, yet so simple, ditching diabetes for good is almost EFFORTLESS!
“Forget about the needles, the ‘sawdust and grass clipping’ diet, and the potentially lethal blood sugar drugs. The supposed ‘global health authorities’ are beating a dead horse with these useless tactics.
“Because Dr. Fred’s breakthrough is all about using your body’s most powerful cravings to help you defeat diabetes once and for all.
“Golden fried chicken…gooey chocolate brownies…and other ‘off limits’ decadent treats can actually HELP cleanse your body of diabetes”
What the plant extract is, the presentation doesn’t say. The reference to olive oil and mono-unsaturated fats is no doubt intended to add a morsel of legitimacy to the claim. But there isn’t any evidence that mono-unsaturated fats “cure” diabetes. Olive oil, and its presence in the Mediterranean diet, gets a lot of credit for improving cardiovascular health, and there is certainly a link between cardiovascular health and diabetes. But nobody has demonstrated, or even claimed, that olive oil cures diabetes or mitigates the symptoms.
And the third miraculous natural cure is tree bark. Here’s just some of what the presentation says:
“The tree bark CUREALL for sunburn, stroke…
“And everything in between!
“This is Dr. Fred’s No.1 recommendation for every patient he sees. No matter what ails them.
“Even deadly serious conditions like Alzheimer’s and hypertension are no match for this natural remedy. And you’d never guess the source…
“This virtual cure-all comes from one of nature’s oldest, simplest materials…
“Tree bark, of all things!
“But before you start chipping away at the old maple in your backyard, hang on just a second!
“We’re not talking about any old tree bark here. No, this one is highly unique. And it grows ONLY in a specific region along the European coast of the Atlantic Ocean.
“There’s almost NOTHING it can’t do
“Nature’s own ALLERGY medicine
“Erase the NO. 2 FEAR of getting older
“Forget the ‘LITTLE BLUE PILL’
“Hush that incessant RINGING in your ears!
“Armor your brain against ALZHEIMER’S disease
“Shield yourself from SUNBURN–from the inside out
“The safest STROKE prevention on the planet
“And that’s just the beginning of what TBC can do for you!
“Just look at what else this Tree-Bark Cure is capable of…
“Shave days off of wound-healing time–and prevent ugly, disfiguring scars
“Promote a youthful, glowing, wrinkle-free complexion
“Soothes the itching, scaly skin of psoriasis
“Even help kids with ADHD–one study showed that within a month, symptoms were barely noticeable!
“And these are just a few more entries on TBC’s mind-boggling roster of benefits.”
What It Would Take to Get These Miracle Drugs Approved As Drugs
So now we have the complete picture: alpha lipoic acid: a plant extract that’s high in mono-unsaturated fats: and another tree-bark extract.
There is a possibility that, with enough assiduous, painstaking lab work followed by carefully controlled clinical trials, one or more of these “miracle cures” might actually be demonstrated to confer some benefit to human beings. Here’s what would have to happen.
First, the active ingredient – the molecule that has the desired effect – would have to be identified, just the way the chemists in the 19th century determined that the active ingredient in those willow-bark infusions was salicylic acid.
Then there would have to be careful studies to determine a safe and effective dose of this active ingredient. One of the steps is usually to establish the minimum lethal dose. This is done, I am sorry to have to report, by killing laboratory animals. Enough of any drug – of just about anything at all – can be lethal; the question is, how small a quantity can be lethal. Once that has been established, they scale way back from that to determine the maximum safe dose for humans.
But will that maximum safe dose be effective? Now there have to be studies to demonstrate what is known as proof of concept –.i.e., will the active ingredient in this tree bark produce even one of those cures listed above. This might be done in relatively small-scale trials. But so far, we’re not anywhere near close to getting this drug approved by the FDA, or any other regulatory authority that I know of.
In the meantime, they need to do what is known as ADME studies, usually in healthy volunteers. It’s important to know the absorption, distribution, metabolism, and excretion of any drug. Based on this information, they can figure out how much to give (and by what route – oral, injectable, intravenous, topical), how often, how long it stays in the system, and other vital information. Even the route of excretion is vital – some drugs are excreted unchanged, and some are metabolized in the liver. The ones that are metabolized in the liver have the potential to interact with other drugs.
Now they have to demonstrate that it really works. This will require big randomized controlled clinical trials. Depending on the specific disease that they’re taking aim at, the trials could be huge, and they could be long-lasting. If it’s preventing sunburn, that’s one thing. They could find out pretty fast if it works. But if it’s preventing strokes, it would be considerably more complex. There are already stroke prevention drugs out there, besides aspirin, that work pretty well. They would at least have to demonstrate that their new drug worked just as well as established drugs (non inferiority).
The best evidence that would likely lead to regulatory approval (and a blockbuster drug!) would be a head-to-head trial that demonstrated that the tree-bark derived drug actually was superior in efficacy, and just as safe, as an established drug. In the case of stroke prevention, a likely trial would enlist persons who had already experienced a TIA (transient ischemic event, sometimes called a mini-stroke) and are therefore at high risk for a full stroke. Because not giving these people an established drug would be unethical, the trial would likely evaluate combination therapy with an established drug plus the new drug compared with the established drug alone.
And the cost of going through the necessary clinical trials to get a new drug approved and bring it to market is huge – it was estimated to average $1.3 billion (with a b!) in 2007, counting the efforts that fizzle.
Given all this, it’s no wonder that the marketers of “nutraceuticals” are not eager to go through the regulatory process. They would rather make their miracle cure claims by some other means, such as the presentation I’ve been quoting. But what you get when you go for a nutraceutical is a lot of big question marks – what’s the right dose, does it really work better than the alternatives, how much is too much, what else am I getting in this little pill?
Speaking for myself, I pass.
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And a word about myself. I have been a medical writer for about 25 years; before that I was a documentary film maker, and some of my films were about medical subjects. I am not a physician, but I have a pretty good scientific background. I wouldn’t dream of recommending any kind of treatment to anyone, and I cannot give medical advice. However, I understand the medical literature and the data and evidence behind it, and I have an inquiring and skeptical turn of mind. In this case it led me to question the hyperbolic claims in the Logical Health Alternatives presentation. In other cases, I scrutinize and question and, sometimes, challenge the positions of some of the established health-care organizations. Eternal vigilance is a small price to pay for health. — Michael Jorrin (aka DocGumshoe)