The only reason I accepted his invitation to circle the dance floor is that his latest foray into temptation has to do with pluripotent stem cells, a highly interesting, extremely complex, and promising area of serious scientific investigation. But before I attempt to follow Dr Sears’ complicated dance routine, there’s another bit of news that I want to put before you. It is, in the considered opinion of Doc Gumshoe, one of the most important news items in the medical field to have emerged in quite some time.

What the results of the TAILORx trial might mean for thousands of women

The results of the trial have not actually been published yet. They were scheduled to have been presented at the American Society of Clinical Oncology (ASCO) a couple of days ago, but the news has trickled out and hit the front page of the New York Times. In a nutshell, it is this: for thousands of women with early stage breast cancer who would, following the current treatment guidelines, have been treated with chemotherapy, this form of treatment may not be necessary. And, given that chemotherapy is in its essential nature a highly toxic form of treatment, if it is possible to treat these patients without resorting to chemotherapy with no sacrifice to treatment outcomes, then by all means, chemotherapy should be avoided.

The trial, TAILORx, (Trial Assigning IndividuaLized Options for Treatment (Rx), was announced in 2006. Its initial objective was not specifically to evaluate the benefits of chemotherapy versus other forms of therapy, but to examine whether genes that are frequently associated with risk of recurrence for women with early-stage breast cancer can be used to assign patients to the most appropriate and effective treatment.

What the trial found was that in a significant percentage of women with early stage breast cancer, perhaps as high as 70%, chemotherapy provides no benefit whatever over drugs that inhibit the action of estrogen or prevent the body from generating estrogen. Tamoxifen and related drugs, termed endocrine therapy, are very widely used; even though these agents do have side effects, including a slight increase in the risk of developing uterine cancer, the side effects of endocrine therapy are quite mild compared with the side effects of chemotherapy. The almost inevitable side effects of chemo include extreme nausea and hair loss. Less frequent but more serious side effects include cardiac and nervous system damage, increased susceptibility to infectious diseases, and perhaps also increased risk of leukemia.

The trial evaluated nearly 10,000 women with early stage breast cancer who had genetic analyses of their cancers. Of these, about 70% had disease marked by the following characteristics: 1), early stage breast tumors measuring one to five centimeters; 2), that have not spread to the lymph nodes; 3) these tumors are sensitive to estrogens; 4), and do not demonstrate the presence of the HER2 protein; 5), finally, an intermediate score on a genetic test that estimates the activity of a group of genes that are known to predict cancer recurrence.

One group of women in this cohort, those with intermediate test scores, was randomly assigned to receive either hormone therapy alone or hormone therapy together with chemotherapy. After nine years of follow-up, the overall survival rates were 93.9% in the women who got hormone therapy alone, versus 93.8% in those women who were treated with the combined therapy regimen. The rates of survival free of any evidence of invasive cancer in those two groups were 83.3% versus 84.3%.

That one percent difference favoring the cohort of women who got the combined therapy suggests that there may be a very few women who get a tiny benefit from chemotherapy. The authors note that these women are substantially younger than the age at which women usually develop breast cancer, and that further study is necessary before arriving at any conclusion.

Based on the overall evidence, the conclusion of the authors as well as that of a number of recognized experts was that the addition of chemotherapy offers no advantage over adjuvant hormone therapy. This helps to resolve an area of doubt in treating early stage breast cancer. Previous studies had indicated that women with scores at the low end of the genetic test could be successfully treated with hormone therapy alone, but uncertainty remained regarding women with intermediate scores. Might it be possible that chemotherapy provided a benefit in terms of survival, albeit a small benefit? The TAILORx study indicates that in women in that range, chemotherapy adds zero benefit while significantly increasing adverse effects. And the great majority of women with early stage breast cancer fall into that category. Estimates are that every year about 60,000 women in the United States who would otherwise receive chemotherapy can now be free from that ordeal.

There are a couple of other interesting and perhaps important take-aways from the TAILORx study. One is that this large, long, and expensive trial was sponsored not by pharmaceutical companies, but by the National Cancer Institute (NCI), which is part of the National Institutes of Health (NIH). If we think about it for just a moment, it’s evident that the pharmaceutical companies are not likely to put their money at stake in a trial of this kind because they’re liable to lose. Having government agencies step up to the plate is the obvious first choice. But Doc Gumshoe wonders about getting some Silicon Valley Billionaires to foot the bill for studies that would potentially be of great benefit to real live patients, and not just to the drug makers. (How about that guy who want to dedicate his $100-billion-plus to putting colonies of humans on planets here and there in the galaxy?)

And another take-away that makes me a trifle sentimental is the fact that thousands of women volunteered to take part in a clinical trial in which they might at random be assigned to a cohort that did not receive the standard treatment. Yes, chemo is an ordeal, but the doctrine supporting it has always been that it could save your life. And now women are being asked to take the chance that they won’t get chemo, and indeed, that chance could cost them their lives. But they said “yes;” they volunteered to enter the trial. In my view, those women acted heroically.

Now, let’s get back to Dr Al Sears and those stem cells. When he implies that stem cells can reverse every disease or medical condition that afflicts us, he’s doing no more than wildly, extravagantly exaggerating. The scientific community certainly recognizes the promise of stem cells, but it also recognizes that at this time, it’s a promise, and the date at which this promise might come true is likely a long way in the future.

A brief introduction to stem cells and what (we hope!) they can do

It must have been obvious to anyone with an elementary understanding of biology that there had to be something like original cells from which other cells developed. The entire living organism, whether a mouse or an elephant, develops from a single egg fertilized by a single sperm. Those first cells divide and multiply in number, and from those entirely undifferentiated cells evolve all parts of the fully developed living being. Those original cells are what we now call embryonic stem cells.

However, the study of stem cells is fairly new. It was just 1981 when scientists discovered ways to derive embryonic stem cells from mouse embryos, and only in 1998 did they discover ways to get embryonic stem cells from human embryos and grow them in the laboratory. These embryos had been created for in vitro fertilization and implantation, and once they were not needed for human reproduction, the egg and sperm donors voluntarily turned them over to scientists for research. This decision ran into a certain amount of flack on the ground that tiny human beings were being used for research; however, it was recognized that at this time there is no way to bring these embryos to term in big glass jars, as in Aldous Huxley’s Brave New World, so research has been able to continue on embryonic stem cells.

Stem cells have colossal potential in treating diseases such as diabetes and heart disease, but research in that direction is still in a fledgling state. It is known that in some tissues such as bone marrow, muscle, and brain, stem cells generate replacements for cells that die as a result of aging, injury, or disease. These adult stem cells are formed in those tissues, and are physiologically induced to mature into the cells forming the tissue in which they develop. (The term “adult stem cells” means only that the stem cells have matured beyond the embryonic stage, and not that they are the stem cells in adult humans.) The stem cells themselves cannot perform the tasks of the specialized cells, but they can reproduce, forming cells such as heart muscle cells, blood cells, and brain cells. The factors that affect the maturation of stem cells include the DNA in the cells themselves and other factors linked to DNA, termed epigenetic factors. Once stem cells become differentiated, they do not evolve to form a different kind of stem cells. For example, the stem cells in the bone marrow evolve to form blood-producing cells in the bone marrow; they cannot evolve to become nerve cells in the brain. However, some researchers hold out the possibility that differentiated adult stem cells can be modified such that they evolve to become completely different stem cells in different tissue. This is an area where a very great deal of research remains to be done.

This area of intense investigation is the creation of what are known as induced pluripotent stem cells. Adult stem cells can be reprogrammed to become like embryonic stem cells by the introduction of embryonic genes. This makes it possible to create a stem cell population that at the same time matches the DNA of the donor of the adult stem cells and also has the potential to evolve into any of the many differentiated stem cell types. Therefore, such cells would be compatible with the recipient if they were to be used for the purpose of regenerating an organ, such as the pancreatic islet cells in a diabetic individual.

The process is more or less as follows: first, adult differentiated stem cells are harvested from the patient needing treatment. Then those stem cells are reprogrammed with embryonic genes, whereupon as they reproduce, they have the characteristics of embryonic stem cells, that being the capacity to evolve in any number of directions. And then – perhaps!!! – these reprogrammed cells can be reintroduced to the donor, forming mature cells matching those in the tissue into which they are introduced. Since these induced pluripotent stem cells were originally procured from the patient in whom they are later to be introduced, they match the patient’s DNA.

All of this is in the category of exiting prospects, with much research still to be done. But there are many, many areas of difficulty. One example: the means of introducing reprogramming factors into adult cells at present consists of using viruses as vectors. Needless to say, this requires extreme caution before the technique is used in humans.

Bottom line, stem cells are a highly promising focus of research, but as a therapeutic tool, they are years and possibly decades away from practical use.

What does Dr Al Sears propose?

In a nutshell, his view seems to be that we don’t need all that hyperscientific folderol about harvesting adult stem cells, reprogramming them with embryonic genes to become pluripotent stem cells, and then reintroducing them into the organs of the adult who might need a new pancreas or a new heart or a new brain. All we need to do is feed our very own stem cells the foods that he can tell us about, if we subscribe to his program, and our own stem cells will deal with just about every disease we’ve ever heard of, and a great many more. Here’s what he says:

“I’ve seen this molecular wonder REVERSE everything from diabetes to spinal cord injury.

“You’ll hear the stories of real patients being cured today.

“And you’ll see the unbelievable research that confirms these results.

“Research that shows this technology’s real potential to…

• Create new brain cells, reversing brain damage and restoring memory⁶ -Nature Medicine
• Generate new pancreatic cells, reversing type 2 diabetes⁷ -Harvard Stem Cell Institute
• Reverse heart aging in 1 month⁸ -Cedars-Sinai Heart Institute
• Rebuild damaged heart muscle, reversing heart failure⁹ -American College of Cardiology
• Turn immune cells into “cancer-seeking missiles” that obliterate tumors¹⁰ -University of California
• Create new retinal cells, restoring vision to the blind¹¹ -University College of London
• Reverse the hallmarks of aging, increasing lifespan by the equivalent of 24 years¹² -Salk Institute
• Eliminate all signs of Multiple Sclerosis in 69% of patients¹³ -Harvard Stem Cell Institute and Mayo Clinic
• Regrow damaged cartilage, reversing osteoarthritis¹⁴ -Mayo Clinic”

The key word in that quote from the eminent Dr Sears is “potential.” Doc Gumshoe is not arguing with Dr Sears about that. But there’s a gigantic gap between “potential” and what he says in the first line, which implies that there have actually been actual cases of actual patients having diabetes and spinal cord injury reversed by means of stem cell treatment. Possibly in the future, but not quite yet.

Of course, what stands in the way of having every man, woman, and child benefit from this molecular wonder is, as by now you have surmised, the villainous conspiracy between greedy Big Pharma and the compliant FDA, that is suppressing information about this pluripotent cure so as to preserve Big Pharma’s colossal profits.

Sears equates the potential of stem cell treatment with Dr Jonas Salk’s polio vaccine, except that he says it is “1,329 times bigger than the end of polio.”

“It was an unparalleled ‘medical miracle.’ Proof of what modern medicine could achieve.

“In fact, no other breakthrough in the 20th century quite eradicated disease like it.

“But there was another part to the story that NOBODY heard.

“You see, after World War II, a small group of drug companies were beginning to grow big and powerful.

“A group we know today as Big Pharma.

“And they were hoping to profit bigtime with drugs to manage polio…

“But the inventor of the polio cure, Dr. Jonas Salk, undercut their plan.

“He famously said that the treatment belonged to the people.

“And he made it available to everyone, completely free of charge.

“In one fell swoop, he stopped Big Pharma’s entire disease profiteering scheme.

“Not only did they lose billions from potential drugs to treat the symptoms of polio…

“They never saw a penny from the cure.

“The drug conglomerates vowed to never let it happen again.

“Not for any disease.

“And to make sure of it…

“They planted their corporate execs in the highest seats of government, including the FDA.

“Which is why, over the course of 7 decades, no other disease would be cured again.

“But now, that’s all about to change.

“You see, a similar disease-ending story is now underway…

“One 1,329x bigger than the end of polio.

“And the drug companies are waging a full-out war to suppress it and silence it.

“Because it could end not just one but EVERY deadly disease, including cancer, diabetes and Alzheimer’s.

“Which means one unavoidable end result:

“The end of Big Pharma’s $1.2 TRILLION drug market.

“But there’s nothing they can do to stop this cell technology from going public.”

How, exactly, is the FDA suppressing, blocking, or sabotaging stem cells as the cure-all that Sears proclaims them to be? They certainly are not standing in the way of stem cell research, which is going on in every major academic center in the country and likely in the whole of Planet Earth. No, what the FDA is doing is precisely preventing Al Sears and others of his ilk from marketing stuff that purports to treat diseases of any kind unless they can present credible evidence that the stuff actually works.

This credible evidence demanded by the FDA consists of experiments, in the form of clinical trials, which demonstrate that the intervention actually makes a positive difference. Inspiring stories about the miraculous “cures” experienced by people whose photographs are displayed in the promotional material do not constitute credible evidence. The stories might just possibly be true, but they might also be hooey. The FDA insists on verifiable data if any intervention, whether a drug or a device or a procedure, is to be presented as treatment for a disease or medical condition. Is this equivalent to suppression? I don’t think so.

Dr Sears goes on with his bold promises:

“The best part: to access this cure…

• You do NOT need a prescription
• You do NOT need a hospital or doctor’s visit
• And you do NOT need health insurance

“I’ve got the complete inside scoop for you today.”

But you have to wait quite a bit for the inside scoop. First, he introduces himself and boasts about how he “travels over 20,000 miles to the most remote regions of the world searching for natural healing secrets unknown to or ignored by mainstream medicine.”

Also, that he has been in on the ground floor of stem cell research since the very beginning. Then, as is absolutely standard in promotions like this one, we get three convincing sounding cases, accompanied by appealing photos, where people were swiftly and totally cured of diseases that had plagued them in some cases for up to 20 years. And the cure was carried out by their very own stem cells!

“In just a moment, I’ll share a simple trick to significantly boost your body’s stem cell levels. One that requires…

• NO Surgeries
• NO Drugs
• NO Prescriptions
• NO Doctor Visits
• NO Health Insurance

“Instead, it’s a ‘6-ingredient cocktail’ containing nutrients found in most household kitchens.

“Nutrients proven to naturally super-charge our body’s stem cell reserves!”

“…. You don’t even have to see the doctor.

“After all, the cure already exists inside YOU.

“You can power your body’s natural capacity to produce stem cells from the comfort of your home. And you can do it using four surprising, safe remedies.

“Discover how — including the full details on these remedies — in my new dossier….”

Before the good doctor actually tells you “in just a moment” how to get hold of this precious information, he promotes two more miracle cures. One we’ve already heard about – Dr Otto Warburg’s assertion, more than 70 years ago, that the essential cause of cancer was oxygen depletion, which Doc Gumshoe discussed back in March 2017 in “The Miracle Cures Keep Coming.” That was in response to Brad Lemley’s promotion about the “Nazi Cure for Cancer,” suppressed, of course, by Evil Pharma. Now Al Sears has a booklet about it, The 8^th Element: Nature’s Universal Cancer Killer.

The other miracle cure is in a booklet entitled Asia’s Wonder Spice: The #1 Cure for Every Disease … Without Side Effects. I have no idea what “Asia’s Wonder Spice” might be, but my skepticism index is in the red zone. If there really was an Asian wonder spice that cured every disease, one might suppose that Asian populations would be a whole lot longer-living and disease-free, which they’re not. If, for example, prevalence of Alzheimer’s disease and some forms of cancer is lower, it’s because those populations die much sooner, from such causes as infectious diseases.

What you need to do to obtain those three precious booklets is subscribe to Dr Sear’s Confidential Cures, which will cost you a mere $39.95 per annum, with an iron-clad money-back guarantee if you’re not totally satisfied. But is that how Dr Sears makes his money? No way. The subscription and his booklets open the way for him to sell you a complete medicine cabinet of supplements, proclaimed to boost the growth of your very own stem cells. And these supplements are the only way to get exactly the nutrients you need in the necessary quantities.

For a serious moment, let’s consider the possibility that Dr Sears’ nutrient formula would somehow foster the growth of stem cells. It’s not out of the question. But those stem cells would be adult stem cells, not pluripotent stem cells. They would evolve in the tissues in which they originated – blood stem cells would become blood cells, muscle stem cells would become muscle cells, and so forth. They would not spontaneously migrate in our bodies to the locations that needed revitalizing. This is not to say that dietary supplements that promoted the growth of stem cells – if they worked! – would be useless. But as for being, in the words of Dr Sears, a “new molecular discovery shown in clinical trials to end not just one, but over one thousand of the deadliest diseases known to man — without side effects,” Doc Gumshoe’s view is, “fat chance!”

By the way, attached to Dr Sears’ spiel is a short list of references. As nearly as I can tell, none of these refer to studies of his products in actual human beings. The ones that are real studies are in the lab (in vitro) or in animals, mostly mice. The other ones are just speculative essays on the huge potential of stem cells.

A serious word: while it’s not my purpose in life to expose every fraudulent medical claim, my concern is that the attacks on pharmaceutical companies, the FDA, and the mainstream health-care profession dissuades people from seeking treatments from qualified medical practitioners who mostly deliver pretty positive results. I base that conclusion on the really marked improvement in statistics such as disease-free survival from most cancers, a plummeting death rate from heart disease, and many others. I would like to know what the disease-free survival rates are in cancer patients who opted for treatment with Dr Warburg’s “8^th element.” I recall the fate of the sister of a good friend’s wife, who had breast cancer and relied on “the healing rays of the sun” for a cure. She died, of course.

* * * * * * * *

A brief addendum: about a year ago I posted a discussion of an about-to-be-launched study, industry funded, whose purpose it was to evaluate the health benefits of moderate alcohol consumption. (“Responses to Comments and a Proposed Study of Alcoholic Beverages,” July 27, 2017) My skepticism index was over the top, for several reasons: one, that the funding of the study by the alcoholic beverage industry would undermine its credibility; and two, that the way the study’s enrollees would be assigned (randomly, of course) either to total abstinence or to the consumption of exactly one alcoholic beverage per day, for a period of ten years, would make it extremely unlikely that the results would have any validity, since the compliance of the subjects would be highly doubtful.

Now we learn that about a month ago the NIH halted recruitment to the study because of the industry’s relationship with the National Institute on Alcohol Abuse and Alcoholism. And Anheuser Busch is pulling funding from the study. By the way, while that institute (not the NIH itself) was soliciting funding from the booze industry for the study, it also turned thumbs down on a study of the association between alcohol advertising and underage drinking. Tells you a little something about that institute.

… and many thanks for all your comments! Best to all, Michael Jorrin (aka Doc Gumshoe)

[ed. note: Michael Jorrin, who I call Doc Gumshoe, is a longtime medical writer (not a doctor) who writes for us about medicine and health a couple times a month. He has agreed to our trading and disclosure restrictions, but does not generally write directly about investments. His ideas, thoughts and words are his own, and you can see all his past pieces here.]