Here in the US, it’s the Thanksgiving holiday weekend. Many of us (myself included) have a four day weekend to enjoy. This year, even though I do have the weekend off, I won’t necessarily be enjoying all of it. The reason is simple: I have to study. Yes, my general surgery board recertification examination is not very long off, and I plan on using much of the weekend, once I recover from the feasting yesterday, to study.
However, before I get to that task, let no one say that I am not good at procrastinating, which is why I couldn’t resist taking note of a story published earlier this week in The Sun: GOING TO THE CHAPEL Mum with months to live claims JUICE kept cancer at bay long enough to see her daughter get married. This story is the worst kind of clickbait and emotional manipulation, combined with a dubious claim about a deadly cancer based on misunderstanding that deadly cancer.
First, the emotion:
Julie Shaw was diagnosed with stage four pancreatic cancer in July.
After doctors revealed her disease had spread to her liver and lungs, she was given a five to ten per cent chance of chemotherapy working.
The 54-year-old, faced with the horrible prognosis, decided to research alternative treatments online.
She discovered Berkson Protocol, an immunity-boosting regime that claims to slow the growth of pancreatic tumours.
Given how close in age Ms. Shaw is to me, I feel particular empathy for her situation. After all, this could be me or any of us of a certain age, facing what is basically a death sentence. There is no cure for stage IV pancreatic cancer, and most people diagnosed with it live less than a year, with the median survival with good treatment being around 8 months (less than four months untreated). In rare cases, there are people with less aggressive disease who survive several years with a diagnosis of metastatic pancreatic cancer. Even in less unusual cases.
I had never heard of the Berkson protocol before; so my first order of business in investigating this testimonial was to look up just what the heck the Berkson protocol is. It never ceases to amaze me that now, after more than 13 years of blogging about dubious cancer “cures,” I still come across treatments that I’ve never heard of. The Berkson protocol, also known as the ALA-LDN protocol, appears not to be one of the more popular alternative cancer cures out there, as it’s not mentioned very much in the quackosphere. What it involves is treatment with intravenous α-lipoic acid and low-dose naltrexone as follows: α-lipoic acid (ALA) (300 to 600 mg intravenously twice weekly), low-dose naltrexone (Vivitrol™) (3 to 4.5 mg at bedtime), and orally, ALA (300 mg twice daily), selenium (200 micrograms twice daily), silymarin (300 mg four times daily), and vitamin B complex (3 high-dose capsules daily). In addition, a strict dietary regimen, stress-reduction and exercise program, and a healthy lifestyle are said to be “essential” for this protocol.
The low dose naltrexone should be a red flag right there that what we’re dealing with is almost certainly quackery. So is its tendency to be mentioned in the same article as Ukrain, which, if you’ll recall, is an unproven cancer “cure” touted by the naturopath for whom Britt Hermes used to work. If you Google the protocol, you will almost certainly come across mentions of a case report in Integrative Cancer Therapies of a man with metastatic pancreatic cancer who lived several years treated this way. Basically, the patient was a 46 year old man diagnosed with pancreatic adenocarcinoma metastatic to the liver in 2002. He underwent a brief course of chemotherapy but had difficulty tolerating it and decided to “go natural.” He found his way to the Integrative Medical Center of New Mexico, where Dr. Burton Berkson practiced and where he now practices with his son Dr. Arthur Berkson, who graduated in December 2012 from a two-year fellowship at Arizona Center for Integrative Medicine at the University of Arizona, founded by Dr. Andrew Weil. If you look at their publication list, as I have, you’ll immediately be struck at how the publications for the ALA-LDN protocol consists pretty much of nothing but case reports (i.e., testimonials), published nearly all in bottom-feeding “complementary and alternative medicine” (CAM) and “integrative medicine” journals.
Low dose naltrexone is, of course, sold as a cure-all in many forms of alternative medicine, despite the lack of evidence for its efficacy. As Steve Novella once noted about it, whenever a treatment is claimed to be effective for a wide variety of illnesses and conditions with different etiologies (a description that most certainly applies to LDN, which is touted for conditions ranging from cancer, to amyotrophic lateral sclerosis, to autism, to celiac disease, to multiple sclerosis, to Parkinson’s disease, to many more), it’s almost certainly quackery, at least for many of those conditions. Basically, LDN is an example of a treatment that had a modicum of biological plausibility that quacks latched onto in order to sell it as a cure-all.
But what about α-lipoic acid? Also known as thioctic acid, α-lipoic acid is an antioxidant that is synthesize in small amounts in humans. It’s a cofactor for several mitochondrial enzyme complexes that catalyze important reactions related to energy production and the catabolism (breakdown) of α-keto acids and amino acids. It also scavenges reactive oxygen species and thus neutralize them. It also affects a number of intracellular signaling pathways related to redox and can activate the signaling cascade also activated by insulin. It’s been proposed as a treatment for diabetic neuropathy, where it might have some value (although the evidence is largely preliminary and inconsistent) and to improve glucose control in type 2 diabetes. It might also have value as a treatment for diabetic vascular disease. Again, much of the data are preliminary. Other than Berkson’s claims, a search of PubMed doesn’t find much in the way of evidence that it is useful as a treatment for advanced cancer, although there is in vitro work suggesting some anticancer activity. Certainly, there is no evidence that would suggest anticancer activity so potent that it could prevent the progression of pancreatic cancer or even cure it in humans. Basically, its evidence base looks like a lot of other compounds with purported anticancer activities: A lot of suggestive in vitro studies, for the most part. It is, however, widely sold as an antiaging supplement and antioxidant, for which extravagant claims are often made, and Burt Berkson himself published a book entitled Alpha Lipoic Acid Breakthrough: The Superb Antioxidant That May Slow Aging, Repair Liver Damage, and Reduce the Risk of Cancer, Heart Disease, and Diabetes. The book is nearly 20 years old, and appears not to have been updated.
No, no extravagant claims there.
Nor here, in the case report:
That J.A. has had comparatively stable disease for more than a 3-year period is a remarkable clinical find- ing and prompts this report. It is the opinion of the authors that the lack of progression of J.A.’s disease cannot be solely attributed to the single dose of che- motherapy he received. It has been reported that gemcitabine’s effect on response rate and survival is disappointing.3 No data exist determining response to partial, moreover a single dose, of this drug either alone or in combination.
The stability of J.A.’s disease is thus attributable to the integrative program developed by one of the authors (B.M.B.). This is further evidenced by the quick progression of J.A.’s primary and hepatic lesions after his voluntary discontinuation of his integrative and successful treatment—an unfortunate but not uncommon decision.
You know what they say about opinions. I also can’t help but note that, reading between the lines, there did appear to be some tumor progression during the ALA-LDN treatment. Of course, if the ALA-LDN protocol were so effective, why is it that the Berkson’s can produce so few case reports? His most recent publication is a small case series (three patients) published in 2009. Three or four cases in 20 years? That’s not very compelling. If you see enough cancer patients, over a time period that long you will almost certainly see a handful of patients who do way better than expected. The real data that are needed (and that I couldn’t find) would be what percentage of all of Dr. Berkson’s pancreatic cancer patients treated with ALA-LDN survive longer than a year. My guess? I bet it’s in line with the usual statistics, or maybe slightly better because patients who can undergo alternative therapies are often not as sick as the usual cancer patient and therefore produce a selection bias for less aggressive cancers. The three cases he’s published are almost certainly cherry picked, as is often the case for alternative cancer cures.
Getting back to Ms. Shaw, interestingly, there are aspects of the Berkson protocol not mentioned on the website. The “healthy” diet and lifestyle actually sounds a lot like the Gerson protocol. Here’s what I mean:
She switched to a vegetarian diet, only bought organic foods, and then discovered Berkson Protocol.
Taking more than 30 supplements, including oregano oil and turmeric, in August, Julie began drinking two litres of organic cold pressed juices a day.
Made up of 3kg of carrots, five beetroots and two bunches of celery, it takes two hours a day to make and the juice is cold pressed rather than blended in order to extract the juice from vegetables.
As well as her juice diet, Julie’s kids took her to Hightree Medical Clinic in Uckfield, East Sussex three to four times a week to have vitamin supplements via an IV drip.
Her daughter Rebecca said: “We weren’t having any scans, but mum was suddenly walking for an hour, or going out to a restaurant for dinner and building an appetite.
It’s becoming clearer now. It looks as though Ms. Shaw is using way more than just the Berkson protocol. Indeed, she appears to be throwing every alternative cancer cure she can find at her cancer. For instance:
Julie refused to give in and discovered a special and targeted low dose of chemo, available privately in Germany – at a cost of £15,000 for four weeks of treatment.
So Ms. Shaw is undergoing way more than just the Berkson protocol, as becomes apparent later in the article and is apparent from her JustGiving profile. She is also undergoing chemotherapy, and she’s adopted a diet that sounds a lot like the Gerson protocol, which, if you remember, involves 12-13 glasses of freshly prepared vegetable juice per day, one each hour every hour, plus a boatload of supplements. The only thing that appears to be missing from her regimen are the five coffee enemas a day that the Gerson protocol requires. I also can’t help but wonder just what the “targeted” and “low dose” chemotherapy protocol is that Ms. Shaw is undergoing in a German alternative medicine clinic. Remember, these clinics frequently sell false hope in the form of experimental chemotherapy and pharmacological therapy protocols as though they were established and then combine them with all manner of quackery, charging huge sums of money in the process.
I found out on her Facebook page that the clinic to which Ms. Shaw is traveling is the Hufeland Klinik:
So not only is she receiving chemotherapy now, but she’s undergoing hyperthermic chemotherapy, where the body is heated to 43° C or more before chemotherapy is administered. Hyperthermic chemotherapy is a real therapy with some evidence that hyperthermia increases the efficacy of the treatment, but, disturbingly, the clinic uses “bacterial lipopolysaccharides” (i.e., endotoxins) in order to induce a fever. I also can’t help but note that hyperthermic chemotherapy is often more brutal than conventional chemotherapy. Ms Shaw is also undergoing vitamin infusions, ozone therapy, immune boosting injections, ultrasounds, examinations and consultations. Basically, she’s using a veritable cornucopia of cancer quackery, plus some chemotherapy, to treat her cancer. I had never heard of the Hufeland Klinik, but fortunately Andy Lewis had. It’s basically a naturopathic clinic. Consistent with that, “detoxification” is a big part of the therapies offered there. I must admit that the scope of quackery being offered there stunned even me, and I’m a bit jaded about just how low quack clinics can go.
So is it all working? Not really:
Scans and blood tests since she has been there have revealed that her pancreas and liver tumours have not grown in size since she was diagnosed in July.
Doctors have also told her that her liver seems to be regenerating and that, while the number of cancer cells in her blood have increased, they have not either formed any new tumours, or increased the size of existing ones.
Julie added: “It’s amazing. I just can’t believe it and I am so grateful to all my family, friends and kind strangers, who have all helped to raise money to make my treatment possible.”
So, basically, her tumors have not shrunk, and the number of circulating cancer cells in her blood have increased. True, her cancer hasn’t progressed detectably. However, again, as I pointed out, even if the median survival of untreated stage IV pancreatic cancer is under 4 months, that means half of the patients will survive longer than four months. Ms. Shaw was diagnosed in July, which was only around four months ago. She’s basically just passed the expected median survival of someone with her condition, and she might be getting some effective treatment along with all the quackery if the chemotherapy she’s getting at the German alternative cancer clinic has any efficacy.
Don’t get me wrong. I’m very happy that Ms. Shaw has lived long enough and well enough since her diagnosis to take part in her daughter’s wedding. That’s great, and I hope she continues to do well. However, the reason she lived that long almost certainly has nothing to do with the Berkson protocol, the juicing, the supplements, or all the other quackery Ms. Shaw has pursued. It almost certainly has everything to do with the biology of her disease, which put her in the group of one half to one-third of patients with her diagnosis who live longer than four months. In other words, she is fortunate; her treatments almost certainly aren’t responsible for her survival, and The Sun is grossly irresponsible for publishing a puff piece that portrays her survival as due to cancer quackery.
I learned to day that Ms. Shaw passed away in January, only a little more than six months after her diagnosis:
32 replies on “Yet another clickbait testimonial manipulates emotions to make cancer quackery appear effective”
Reading the list of things that patients . . . er, victims of many quacks are often required to do, imbibe, etc, it has struck me that the multitude of items is actually a feature of such protocols, offering lots of opportunities for failure. Forgot your sixty-first supplement tablet of the day during the third month of therapy and may have used non-organic brusel sprouts up your bum? No wonder it didn’t work. Sorry you are dying, but you cannot expect my magic cure to work if you are so lackadaisical about these serious medical regimens.
Right. In addition, one of the idiots I survey usually includes the tag line that the woo won’t work its cure on cancer IF the patient had already used chemotherapy because it ruins liver function. Thus, if this advice were followed, quackery might become the treatment of FIRST, rather than last, resort.
You can guarantee if their woo doesn’t work – blame the victim. They weren’t on it long enough, left it too late for the “protocol” to work, didn’t do it properly or didn’t have the right attitude/belief. They will even blame those around their victim.
I was going to make your day worse, Orac, by pointing to the front page headline in another of the UK’s magnificent tabloid shitrags, the Daily Express. Unfortunately that headline seems to have vanished from their web site in favour of CAPITALISED CLAIMS about the glories of Brexit.
When I was in the newsagents earlier today I saw it carried the dominating headline ‘Hope for a cancer cure’, which on inspection turned out to be a mention of a small study planned upon the basis of some success in mice. Obviously it could turn out very well in coming years, but more likely it will not. In the meantime, a million Express readers will become disillusioned about how scientists keep making these fantastic claims but never live up to the promise, yet all the while quacks will get a free rein to deliver people to an early death.
Sorry. I’m just in a foul mood today.
If a million Sexpress readers wish to be delivered an early death, who are we to stand in their way?
Because we have ETHICS. An ethical person does not just sit back and laugh while desperate people are being duped and fleeced. An ethical person stands up and tries to educate the public about the dangers of quackery.
I would be a little careful about calling Berkson a quack, although I too am dubious about the degree of LDN benefit. He’s had some unusual medical successes when he was younger, and like most researchers, perhaps his best insights conceived earlier than later.
As for this pan-can claim, I think more granularity in evaluation is needed, like most alt med claims. To me, the easier part of alt med appears to be improvement of quality of life for a while, improved blood scores, and perhaps avoidance of catastrophic malnutrition with replacement of essential nutrients, whether that nutrient is usually exogenous or endogenous. Individual survival improvement could be a little or a lot at this level, only one break in the chain of life still kills you.
More interesting to me, is the claim of inhibited transition of floating cancer cells or clusters to new mets. I’m as interested in the how as much as the what he observed, measured and evaluated. A successfully treated integrative patient is likely to have measurement opportunities that are often highly distorted and unintelligible in conventionally treated (only) patients with massive side effects of particular treatments.
The evolving link of integrative medicine is pulling other’s partial successes, including conventional treatments or their modification, all together to create a comfortable, durable remission on demand. MSM has skipped out on parts of this for a long time.
Berkson is a quack. It’s hard for me to form an opinion different than that he’s a quack based on his writings, his website, and how he keeps using a treatment that he hasn’t been able to validate in anything resembling a halfway decent clinical trial in over 20 years. Hell, Nicholas Gonzalez’s cherry picked case series of 12 pancreatic cancer patients from 1999 was more convincing than Berkson’s evidence, which consists of much less clinical evidence.
My BIL has pancreatic cancer–dont have details on type–and has survived (following standard chemo) way beyond expectations, for over a year. It came back and they gave him only months at best, He was going to go ti some quack olace in Arizona for, get this–$150,000!–it sounded a lot like this in that it iffers “low dose chemo”, along with a whole host of the ususal nonsense. Am I correct that low dose chemo can do serious harm by encouraginf resistance?
At any rate, he hasn’t gone there yet and the tumor has stopped growing again with conventional treatment. It’s the prayers accoe1ding to the family–
I have a cast on my hand and typing is challenging, I keep getting unwanted numbers, so at the end that should be according,
Also, I think the BIL is an outlier, but no one in the crazy christian family listens to me.
Cancer is hard enough for the patient and family to bear, let alone confusing the matter with dubious treatments or reality-denying spirituality. (Please note: I’m making no statement about faith in general, or it’s place on such a journey, but rather speaking from past experience dealing with family members convinced that their deity has promised healing and we must believe it to be true. I can’t help but think this is of more comforting to the person professing it than the person “needing” to “be healed”.)
Berkson was invited to the National Cancer Institute 2 times in order for them to review several cases of stage 4 cancers that were reversed with his protocols. The NCI oncologists concluded that his protocols were valid.
This is a
Newsletter that NCI sent to American oncologists. Take a look for yourself.
Alpha lipoic acid was originally a investigational prescription drug. Dr. Berkson was the FDA principal investigator for 23 years. He believes that it never got on the market because it had too many indications.
Burt Berkson MD MS PhD (University of Illinois, cell biology of microorganisms)
Former instructor and professor (Rutgers University, Chicago State University, University of Illinois, Cleveland Clinic Hospitals, Case Western Reserve Hospitals, New Mexico State
University) Presently Adjunct Oklahoma State College of Medicine, Tulsa.
That’s nice. That was over five years ago. Got any data that are more recent and more convincing? Got any clinical trial data? Until you do, it’s unethical to be treating cancer patients with this protocol outside of a clinical trial.
I note that the NCI Best Case Series Protocol produces a lot of false positive results because, by design, it’s evaluating cherry picked (i.e., “best”) cases. You might notice that I mentioned Nicholas Gonzalez in a comment above. He presented a best case series of 12 patients that was far more convincing than yours is. When his protocol was tested in a clinical trial, it failed miserably.
Does the real Burt Berkson refer to himself in the third person and use strange line breaks along with copying and pasting? (“Dr. Berkson was the FDA principal investigator for 23 years.”)
“Global Advances in Health and Medicine”? Struth, Sage Press are trying really really hard to work the parasitical publisher side of the street, with a journal name like that.
More sophisticated patients may reject over-institutionalized trial requirements as infringements on their educated choices by a corrupt, ineffective, patronizing medical establishment. Although the unsophisticated patients out number us, above average patients can do a lot of due diligence to weed their choices if they are allowed and not mocked or intimidated when they are at a vulnerable stage.
Also I subscribe that adequately described and quantified patients, individually, with adequate (super)nutritional support will begin to look like more fungible datapoints that can be better analyzed retrospectively in many cases. Already in this belated dawn of weakly personalized medicine, the pharms themselves will confront this issue with major products that only pick off a small slice (e.g. 5%-20%) with, hopefully, very high efficacy with unknown durability.
I know we’ve suffered losses of (life)time, quality, and money from interference of various facets of the medical financial complex. I will acknowledge CAM providers have serious problems. However the mainstream is destroying us economically and socially, whatever their self congratulatory technical merits. I appreciate the efforts of Dr. Berkson, particularly on lipoic acid and his educational background discussions and commentary, where I can’t say that for a number individuals targeted here.
If you are rejecting properly done clinical trials for quackery, you are not sophisticated . . . by definition.
It is truly unethical to indicate the faults of someone in a disapproving way.before you know all of the facts.
A new paper was just accepted describing the reversal of a stage 4 renal cell carcinoma using the protocol.
A practicing doctor finds it difficult to find time to
publish all of his successes, and failures, because he is too busy working in his clinic trying to help people get better.
There are many more case histories and series that will be published in the future when time permits.
Case histories and series are NOT adequate evidence. They are hypothesis-generating, not hypothesis-confirming. Also, you’re using the same excuse I hear over and over from people hawking dubious cancer cures, that they’re “too busy saving lives” to bother to do actual research to prove their treatment actually saves any lives.
Tell me: Do you have IRB approval for your clinical research activities?
All of our cancer patients also have an oncologist.
I don’t see these patients until conventional therapy has failed.
I would never say that I cure cancer, however, many patients don’t die, the cancer becomes dormant, and they continuing living a normal life when on my protocol sometimes for many years.
So you seem to be telling me you don’t have IRB approval for your research. Good to know.
Again, there is variability in progression of cancer. Without clinical trials, you can’t tell if you’re actually doing any good. I’ve looked at your publish case reports. There might be something there. There more likely is not. Again, without clinical trials, there’s no way to know.
Who is going to pay the clinical trials since the agent can no longer be patented?
That is a serious problem. If a drug company puts it on the market, there will be no patent protection.
Anther company can under sell the product.
That’s what the NCCIH is for. Also the NCI. Apply for a grant, just like the rest of us do.
I really get annoyed when people refer to themselves in the 3rd Person….
A lot of sophisticated CAM patients won’t join blind trials, we want a piece of the action and decisions. The highly experienced non medical experimentalists (real PhDs, chem/biological patents, successful products) prefer better choices in real time and internal data for their N=1 trials. They often seem to do well, much better than expected (warning, small statistical base). One of the nice aspects of CAM MDs is that they often treat people as co-learners and respect multidisciplinary environments that MSM fail in. Just because an alt MD doesn’t like your chemo doesn’t mean he won’t support it vs MSM sh-, blaring their ignorance on supplements.
What nonsense. What you’re really saying is CAM patients won’t join blind trials because they want assurance they are getting the experimental drug. They want a guaranteed cure, failing to realize there are not guarantees in life and certainly none in quackery.
That’s a BS excuse if ever I heard one. What you’re really saying is you don’t want to be bothered with proving safety or efficacy if there’s nothing in it for you, but you’re just fine experimenting on sick people as long as you’re making a buck.
Who’s saying the agent can’t be patented? And you don’t need to patent the agent, just the delivery system. As we all saw with the EpiPen debacle, the medication is generic and cheaply available. It’s the delivery system (one-click pen) that makes it special and expensive.
If that’s the best you’ve got you’re really not trying hard enough.
Also, what about that IRB?
What is it with “Protocol” that makes it such a Worship Word for the labcoat-cosplay pretend-oncologists? Are any of them content to put together a
bamboo aeroplanemagical-thinking-driven mixture of ingredients and just call it a treatment? No, it always has to be a “protocol”.
One must always properly follow proper protocols.
“One must always properly follow proper protocols”…as one embarks on one’s Healing Journey, confident that therapy has targeted the underlying cause of dis-ease rather than mere symptoms.
That’s the only way to achieve at-one-ment.