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.
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: