A couple of months ago, I discussed patient deaths at an alternative medicine clinic in Europe, where a naturopath named Klaus Ross had been administering an experimental cancer drug (3-bromopyruvate, or 3-BP) to patients outside the auspices of a clinical trial. 3-BP is a drug that targets the Warburg effect, a characteristic of cancer cells first reported in the 1920s by Otto Warburg in which the cancer cell changes its metabolism to shut off oxidative phosphorylation (the part of glucose metabolism requiring oxygen that produces the most energy) to rely almost exclusively on glycolysis and anaerobic metabolism. From a cancer cell evolution standpoint, one can understand why cancer cells would behave this way, as this change allows them to survive in environments with much less oxygen than normal cells, but the side effect of the Warburg effect is that cancer cells consume a lot of glucose for their energy needs. Indeed, positron emission tomography (PET scanning) takes advantage of this characteristic of cancer cells to use glucose labeled with a positron-emitting isotope that accumulates in cells. The result is that cancer cells, which in general use a lot more glucose than normal cells, light up compared to the surrounding tissue, allowing the identification of areas suspicious for cancer. Targeting the Warburg effect is therefore a strategy to attack cancer cells preferentially.
Since I wrote about the tragic deaths of those cancer patients, I’ve been seeing stories about German alternative medicine cancer clinics popping up in my newsfeed over and over again. Intuitively, you’d think that a scientifically advanced economic powerhouse like Germany would have stricter regulations over the practice of medicine, but, the more I looked into these clinics, the more I realized that there are a lot of quack clinics in Germany every bit as quacky as any clinic in Tijuana, but with a twist. Like Mexican alternative medicine clinics, German clinics often charge enormous sums of money for treatments that range from the unproven to the dubious to pure quackery. However, in addition to the rank quackery, German cancer clinics include legitimate experimental drugs that are as yet unproven and might even only have cell culture or animal evidence supporting its potential efficacy. Indeed, 3-BP is just such an example. It is a legitimate candidate cancer drug that’s in the pipeline, having shown promise in cell culture and animal experiments, but that has no human data from systematic clinical trials yet, just a handful of anecdotes when it was tried in humans under desperate circumstances. Not surprisingly, Klaus Ross’ main clinic is in Germany, and, like so many other clinics there, he was administering an as-yet-unapproved drug to humans.
So, prodded by a couple of recent stories from the UK, I decided to take another look at these German cancer clinics.
"Written off" by doctors and now doing well
In the world of alternative medicine cancer cures, testimonials for a treatment almost always include the patient bitterly recounting that conventional oncologists "wrote her off" before she discovered whatever miracle cure that she believes to have saved her. There are many variants. There’s the "I was given six months to live" (or one year or two months or whatever) trope, followed by the exulting that it’s now several years later and "I’m still alive." There’s the "doctors told me to put my affairs in order" trope. It turns out, though, that the vast majority of the time, the patient’s good fortune to remain alive can be explained by the biological variability of the disease, a mistake on the doctors’ part in estimating prognosis (always a tricky and inexact art), or a better response than expected to previous treatment with conventional medicine. Sometimes, these anecdotes rely on exaggeration on the part of the alternative medicine practitioner about the odds of surviving. I’ve deconstructed more of these testimonials over the years than I can remember.
Stanislaw Burzynski, the Polish expat physician (but not oncologist) who treats patients with what he calls "antineoplastons," is a master of this technique and several others to make it look as though he is saving lives when in fact he is not. For example, he routinely brags that there has never been anyone who has survived, for example, diffuse intrinsic pontine glioma (DIPG), and thus if there is any patient of his who survived it must be because of his antineoplastons. While it is true that the vast majority of patients with DIPG do very poorly, it is not true that none survive. There is even a registry of survivors maintained. It’s small, because few survive, but some do survive. Burzynski is also a master of exploiting diagnostic uncertainty. Because DIPGs, by definition, are located in the brainstem, often they are not biopsied because of the hazard and instead are diagnosed based on how they appear on MRI. It turns out that there are MRI abnormalities that can mimic the appearance of DIPG but are something else. Then there is biological variability. For example, deadly gliomas are indeed almost uniformly fatal within 12-18 months, but there is a "tail" to the survival curve, and patients surviving five years and beyond, while definitely not common, are not as uncommon as Burzynski would have you believe.
I mention biological variability because another aspect of these stories that can mislead the public is that patients frequently don’t understand that not enough time has passed to say with any confidence that they are survivors. This brings us to the story of Pauline Gahan, a rather extreme and sad version of this aspect of alternative cancer cure testimonials.
Because I have Google Alerts set up for various terms related to alternative medicine and cancer, I frequently become aware of stories about alternative medicine cancer cures. Such was the case last week, when a Google Alert led me to this snippet from an interview that aired Thursday a BBC Radio 5 show, under the title 'Why I spent 300k on "unproven" cancer treatment' abroad'.
This is a shorter snippet from a longer interview by Emma Barnett on 5 live Daily from October 20 with Pauline Gahan, a woman who spent £300,000 at a German alternative medicine clinic to treat her metastatic stomach cancer. To raise the money, she sold her house and her car, renting her house back so that she could continue to live there. The full segment begins around the 10:25 in the three hour radio show. Unfortunately, the story is framed around the question, "What do you do when the NHS says no? What extent will you go to?" Barnett does then note that an oncologist, Professor Karol Sikora, has expressed concern about patients from the UK are spending "vast amounts of money" on experimental treatments abroad with no proof of benefit.
A celebrity testimonial
We’ll get back to the full interview in a moment, but first I have to mention another pernicious phenomenon exhibited by this interview, and that’s the celebrity testimonial for alternative cancer cures. The first one I remember covering, at least with respect to German cancer clinics, is that of Farrah Fawcett, who in 2007 sought out a German cancer clinic for "experimental" treatment of her recurrent anal cancer. Although her publicist denied vehemently that she was being treated with alternative medicine, I couldn’t help but note that she was treated at Klinik Winnerhof in Bad Wiessee, which at the time was best known for galvanotherapy, also sometimes called bio-electric therapy. Not surprisingly, it is unproven and implausible. We don’t know whether Fawcett used galvanotherapy, but we do know that she did go to a clinic best known for offering it and that ultimately she died of her disease in 2009 at the age of 62.
Before interviewing Pauline Gahan, Barnett referenced the story of British actress Leah Bracknell, best known for having played Zoe Tate in the British soap opera Emmerdale from 1989 to 2005, who was diagnosed with stage IV lung cancer recently. What brought Bracknell into the news, aside from her being a celebrity with a terminal cancer diagnosis at a relatively young age (52), is that she has been raising money to go to a German cancer clinic. The last report I saw showed her having raised £30,000 of the £50,000 needed. Indeed, Prof. Edzard Ernst wrote about her story a couple of weeks ago noting:
Why Germany? You may well ask.
Germany has long been praised by fans of alternative medicine for its liberal stance on all sorts of unproven or disproven treatments. In Britain, there are just a few physicians who are devoted to alternative medicine; in Germany, there are thousands of them. In addition, Germany has a healthcare profession called the ‘Heilpraktiker’, a poorly regulated leftover from the Third Reich. Recently, a German Heilpraktiker was implicated in the deaths of several cancer patients who had travelled from abroad to receive his treatments, because German law is more liberal in these matters than other European countries. A Heilpraktiker has not studied medicine, yet is legally permitted to make all sorts of unsubstantiated claims and treat many serious diseases with unproven therapies.
Ernst notes that the German clinic to which Bracknell wants to go is the Hallwang Private Oncology Clinic. It turns out that this is very same clinic at which Pauline Gahan is being treated. So it’s worth taking a look at this clinic, what it offers – and what it claims.
Hallwang Private Oncology Clinic: Quackery, quackery, quackery
Upon learning the identity of the clinic where Bracknell wants to go and Gahan has gone, it befell me to fire up Safari and check out its website. Not surprisingly, the Hallwang Clinic website contains a number of very obvious red flags. For instance:
Healing-oriented and individualised medicine considers all aspects of lifestyle and not only relies on conventional treatments and recent cutting-edge developments in medicine, but also takes into account our experience in natural remedies and is open for alternative treatment options in order to work in synergy with conventional treatment strategies. We always try to be as natural as possible and as conventional as needed to achieve the best results. Integrative Health Concepts are successfully used in many diseases including malignant diseases, neurological disorders as well as in prevention and rehabilitation.
That’s nothing more than the usual blather you see on most integrative medicine websites, but take a look at what Hallwang offers: homeopathy, dichloroacetate (DCA), micronutrients and orthomolecular medicine, high dose vitamin C and other nutrients, whole body hyperthermia, ozone therapy and hyperbaric oxygen, and "many more according to your needs."
It should hardly need to be mentioned to my readers that homeopathy is pure quackery, but, given that its inventor Samuel Hahnemann was German, German quacks still seem to love it. I discussed DCA in the context of my discussion of 3-BP, because both drugs have a similar mechanism of action in that they both target the Warburg effect. DCA became popular among cancer quacks back in 2007 after a promising rodent study was published and made the news. Eventually, a pesticide salesman named Jim Tassano started importing DCA, which is easily synthesized, from China and other places, and selling it online. Thus was born DCA as an alternative cancer treatment. Like 3-BP, it is a legitimate experimental drug. It even has more evidence in humans that 3-BP. Unfortunately, like 3-BP, it is still thus far unproven, and its having been co-opted by quacks makes it doubtful that it will ever be validated as an effective cancer treatment. Then, of course, orthomolecular medicine and high dose vitamin C (and other vitamins) are pure quackery, as are ozone therapy and hyperbaric oxygen therapy (HBOT). HBOT has legitimate uses in burns and wound healing, but for cancer, not so much.
So what we have here is a clinic offering a variety of quackery, but there was another red flag, one that I can’t recall ever having seen on any alternative medicine clinic website before. Actually, more appropriately, it’s something I don’t recall ever having failed to see: who’s running the clinic and who the doctors are there. For instance, under Your Physicians, the website says:
We take pride in the commitment of our physicians to provide excellent care to our patients and their families.
Our team of head physicians and experienced clinical residents is specifically trained in internal and oncological medicine and lead an intensive research and academic program on cancer medicine.
That’s nice, but who are these physicians? I looked throughout the website and couldn’t find them. I did Google searches and couldn’t find out who runs Hallwang. Even the quackiest of quack clinics and naturopaths identify who runs the clinic and post short bios. The same sort of information-free blurbs can be found under Nursing Team. No, wait. There was one exception. The section on Psycho-Oncological Care shows a photo of someone named Benjamin Morlok, but not much else. Morlok has a Facebook page and a website, which identifies him as a financial coach, dream therapist, and cancer counselor. To say that I found this very odd and troubling is an understatement.
I was able to find a name, Dr. Jens Nolting, mentioned by patients on discussion boards here, here, and here, but I was able to find little or nothing else out about him.
Ultimately, I found more names, but that is a topic for tomorrow. In the meantime, let’s look at this narrative of false hope.
The false cancer narrative: Hope versus the NHS
With that background, let’s circle back to the story of Pauline Gahan. First, however, let’s take a look at the sort of news coverage she’s engendered in the UK media. Here’s a sampling of typical headlines:
- "Woman who was 'written off' by doctors in the UK is now responding well to cancer treatment in Germany"
- "NHS told me I was going to die of cancer... but now I've almost beaten the disease, thanks to treatment in Germany"
- 'Family of terminal cancer mum "written off" by UK docs say life-saving treatment in GERMANY having "profound effect"'
- "Terminally ill mum close to beating cancer"
- "Wunderbar! German Docs Give Cancer Gran New Hope ; TERMINALLY-ILL WOMAN RESPONDS TO SPECIAL TREATMENT AFTER BEING 'WRITTEN OFF' IN UK"
- "I sold my house to fund cancer treatment in Germany"
There’s another pernicious narrative buried in these alternative cancer cure testimonials that is particularly prominent in stories out of the UK, and that’s to blame the NHS for not covering unproven treatments. Basically, many of the stories are spun in such a way as to portray the NHS as cold and heartless for not paying for unproven cancer treatments, which are portrayed as the patient’s only chance to live, whether they actually are or not:
Another example is here.
Notice how at the end of each story, it’s pointed out that the Gahans will have to raise a lot more money to continue the treatments.
It’s a narrative that popped up time and time again five years ago, when there seemed to be a steady procession of British patients with incurable brain tumors raising money in a very similar way to how Gahan and Bracknell are raising money to go to the Burzynski Clinic in Houston. Story after story portrayed these patients as victims of the NHS and the NHS as being too interested in saving money to pay for Burzynski’s "experimental" treatment. Being a government entity, the NHS was also an easy target for those with a political ax to grind. Never mind that the NHS trusts are quite reasonable in not wanting to waste government funds to pay for ineffective or unproven treatments in foreign countries. In fact, it would be quite irresponsible for the NHS to do otherwise. After all, should the NHS pay £300,000 for an unproven treatment? It just doesn’t make sense.
So what treatments did Pauline Gahan undergo, anyway?
So back to the story of Pauline Gahan, as told to Emma Barnett. Basically, she was admitted to the hospital in May with leg pain after a flight home from Australia, which turned out to be due to deep venous thromboses. She suffered internal bleeding from anticoagulation, which led to an endoscopy, which found stomach cancer. She had two "operations" for her clots. It’s not clear to me what those might have been, unless she underwent thrombectomy. She even admits that the reason she had trouble walking was because of her DVTs, which meant that she couldn’t fly to Germany and instead went there in a camper van. After three weeks there, she states that she felt much better. That could partially explain the pictures of her looking so ill back in May compared to how she looks now, which is much better. She was probably fresh from her diagnosis and the procedures done on her. Be that as it may, once again, a familiar story is told. A patient receives a devastating diagnosis. She hears testimonials from a dubious clinic. She decides to go there, but it’s expensive. So she and her family sell the house and car, undertake prodigious fundraising (e.g., through GoFundMe), and go to the clinic
Having been able to find so little in various news stories and on the Hallwang website, I was actually most interested in how Gahan described her initial treatment. According to her, every day she had five or six infusions, including vitamin B, and "liver detox." That didn’t interest me much, as it was fairly run-of-the-mill quackery that you can find at any naturopathic clinic. My main concern with the quackery is that none of it is effective for anything other than draining a patient’s wallet and that we have little idea how these treatments might interfere with the use of real medicines. Gahan also mentioned something that sounded like "renavap," but I couldn’t quite catch it. There is something called RenaVast, which is an unapproved veterinary drug claimed to be able to treat renal disease. Somehow I doubt that’s what the clinic gave her, as she said they told her it would transiently raise her body temperature. I note that German alternative cancer clinics are very big on whole body hyperthermia, but this sounds like a half-assed attempt at it, because usually when it’s done it requires the use of whole body thermal chambers or hot water blankets. There’s also not a lot of evidence that whole body hyperthermia is an effective adjunct to treat metastatic cancer, although there are clinical trials ongoing. It is at best experimental.
Again, one of the key characteristics of German alternative medicine clinics, particularly when compared to Mexican alternative medicine clinics, is that they often combine unapproved and experimental drugs with all the quackery. (True, Mexican clinics often administer stem cell treatments.) That’s why the next part of the interview is where my ears pricked up. Gahan mentioned that her immunotherapy consisted of a drug called Keytruda (generic name: pembrolizumab). This is a member of a class of new biologics and drugs known as immune checkpoint inhibitors. It’s a drug that is FDA-approved for metastatic melanoma and metastatic non-small cell lung cancer, with clinical trials having accrued for metastatic head and neck cancer and urothelial cancer.
I recently discussed immune checkpoint inhibitors, such as drugs and antibodies targeting PD1, a key protein, in the context of Vice President Joe Biden’s Cancer Moonshot initiative. Basically, drugs like Keytruda target Programmed T cell death 1 (PD-1), a membrane protein found on the surface of a class of immune cells (T cells), which, when bound to a protein known as programmed T cell death ligand 1 (PD-L1) on tumor cells, results in suppression of T cell activity and reduction of T cell-mediated immune responses. That’s why PD-1 and PD-L1 are referred to as immune down-regulators or immune checkpoint "off switches." Targeting this off-switch, shutting it down, can reactivate the body’s immune response against the tumor. There’s no doubt that immune checkpoint inhibitors are a big deal, and this class of drugs is one of the hottest areas of research in academia and pharma today. In some cases, dramatic responses have been observed using these drugs.
On the other hand, immune checkpoint inhibitors are no panacea. Even the Cancer Moonshot report acknowledges this:
The success rates of first-generation cancer immunotherapies, such as checkpoint inhibitors, genetically engineered T cells, and new immune activators have improved remarkably over the last 10 years, resulting in durable, long-term survival—and, in some cases cures—for a subset of patients with advanced cancers such as melanoma, blood, and lung cancers. However, only 10-20% of patients with these cancers have long-term responses to current immunotherapies. We must learn why some patients who have melanoma (such as President Carter) or lung cancer respond to checkpoint blockade immunotherapy, whereas patients with many other types of adult cancers, including ovarian, breast, pancreatic, brain, and prostate cancer—as well as most pediatric cancers—have brief responses or do not respond at all.
Gahan has stomach cancer, and there is actually evidence that Keytruda is active against stomach cancer—if the cancer makes PD-L1. The Lancet recently published a phase I trial of Keytruda in gastric cancer that studied 39 patients, 36 of whom were evaluable for tumor response. Eight patients (22%) were deemed to have had an overall response, but all responses were partial. Given that gastric cancer generally doesn’t respond well to chemotherapy, these results were actually pretty good, good enough to be considered sufficiently promising to warrant phase II clinical trials. It is, however, no miracle cure, contrary to the way it’s being represented to the press, which is how Hallwang appears to have represented it to Gahan. Actually, it’s not being represented at all, because most of the news stories don’t bother to identify the immunotherapy being used at Hallwang. They just call it "immunotherapy." It wasn’t until I actually listened to this interview that I could figure out which specific experimental treatment that Hallwang was actually using.
Hallwang also used some sort of vaccine therapy, which Gahan describes as having been made from her own DNA. It’s hard to tell what, exactly, Hallwang was doing, but it sounds like a neo-antigen vaccine. The basic idea behind such a vaccine is simple, although the production is very difficult. Tumor is collected by biopsy. Its DNA is sequenced and compared to the DNA sequence of normal cells. Mutations in the cancer cells are identified, of which there can be as few as ten or as many as thousands. Bioinformatics algorithms are then used to identify which mutated genes make cell surface proteins that could potentially serve as antigens, and peptides are synthesized in the laboratory based on the identity of those proteins to make a vaccine. The problem, of course, is that this technique is highly experimental as well, as this review article and article in the lay press show. It’s also, at least for now, very expensive because of all the sequencing, analysis, and synthesis of custom peptides that are required. Basically, it’s not clear whether these vaccines will pan out.
Did Hallwang cure Pauline Gahan?
Reading this story, you might well ask the question: Did Hallwang cure Pauline Gahan? It’s a reasonable question given her glowing testimonial and apparent good health now. The answer, sadly, is: Almost certainly not. I can hope that she is cured, and I can be happy that she is doing well, but my scientific knowledge of the natural history of metastatic gastric cancer tells me that she is incredibly unlikely to have been cured.
Unfortunately, the way this story has been presented is that Gahan is "almost cured." However, remember that she was only diagnosed less than six months ago. That’s nowhere near enough time to tell if she’s even survived longer than expected. For one thing, the five year survival rate for stage IV gastric cancer is 4%. So people treated normally with conventional therapy can and do survive five years. It’s very uncommon, but it happens. In fact, Gahan has just passed her expected median survival for a woman age 55-64, roughly five months. While I can understand the Gahans’ joy that their mother is still alive, from an oncology standpoint it’s hard to be too optimistic about how she’s doing less than six months after diagnosis. Not nearly enough time has passed.
Since none of us have seen the scans, we can only rely on her report that the tumors in her stomach, esophagus, and lymph nodes have disappeared and that she only has tumors left in her liver. What that means is that, after £300,000 of experimental drugs mixed with pure quackery, Gahan has had a respectable partial clinical response. In other words, she’s one of the lucky 20% or so whom we would expect to have had a partial response to Keytruda based on the study I cited above. Unfortunately, partial responses are not cures, and there’s little reason to expect that further treatment will eliminate the remaining tumors. It might, but even if that happens the most likely outcome will still be recurrence and death. We know this because we know gastric cancer is a nasty actor and that, once it’s metastasized, long term survival is very rare. Also, while there is no doubt that tumor shrinkage in response to therapy is certainly better than no shrinkage or tumor growth, tumor shrinkage often does not correlate with prolonged survival.
Perhaps the worst part of writing about these stories is having to be the voice of reality. That’s often misinterpreted as being the voice of doom, and I’m acutely aware that, should the Gahans read this, they will think I’m trying to crush their hope. In actuality, I really do hope their mother is cured and can live a long time, but that hope does not change my assessment of the Hallwang Private Oncology Clinic, which is selling false hope to desperate cancer patients like Gahan at a very high price. It doesn’t change my opinion that the Hallwang Private Oncology Clinic is engaging in very unethical behavior.
Hallwang: Combining quackery with misuse of cutting edge treatments
In thinking about the Hallwang Private Oncology Clinic and the many German cancer clinics that operate in a similar manner, I have to conclude that they are as bad as Stanislaw Burzynski, if not worse. Hallwang, for instance, doesn’t publish its results and won’t even report its results. Its < span=""> href="https://www.facebook.com/Hallwang-Private-Oncology-Clinic-414100488682843/" rel="nofollow">Facebook page might be full of testimonials of happy patients whose lives Hallwang claims to have saved and glowing scientific reports about immunotherapy of cancer, but none of these scientific reports actually come from Hallwang.
Basically, like any good con, Hallwang asks patients to trust its doctors, to take it on faith that its protocols do what is claimed for them. It does this in order to extract large quantities of money from their wallets, even if it forces them to do things like Gahan, such as selling their houses and other valuables, taking to the Internet to raise money, and going into deep debt to pay for a combination of seemingly state-of-the-art experimental therapies that haven’t been approved or validated for what they’re being used for plus outrageous quackery. After all, believing that Hallwang is the only place that can save your life is powerful motivation to go out and raise that money. As Prof. Sikora put it later in the interview, Hallwang uses very experimental treatments in a "blunderbuss" fashion, basically throwing everything but the kitchen sink together with no sophistication. We can’t even know if these doctors know what the hell they are doing. Patients are treated, and, as far as we can tell, no systematic record of how well these patients do and how long they survive is kept, or, if such records are kept, they are kept secret.
That’s the worst thing of all. Think of it this way. What if the doctors at Hallwang and other German cancer clinics really do have protocols using experimental drugs that cure cancers that can’t now be cured and save lives that can’t now be saved by conventional medicine? Failure to publish these protocols and their results is not just unethical, it’s downright criminal because, without publication, no other patients can benefit from their protocols unless they come to Hallwang. The doctors at Hallwang basically treat their protocols as trade secrets, so that their clinic is the only place such good results can be obtained.
That’s the best case scenario. Now let’s look at the worst case scenario.
Consider another possibility about clinics like Hallwang. Their protocols don’t work any better than conventional medicine. They almost certainly don’t even work as well as conventional medicine. However, combining a "make it up as you go along" approach to the use of experimental drugs with the addition of "holistic quackery" appeals to desperate patients who want hope, are prone to believe the "best of both worlds" sales pitches, and like the idea of "individualized" treatment regardless of whether it really is or not. Publishing their true results would be a threat to their ability to charge outrageous sums of money to patients like Pauline Gahan.
Of the two possibilities, the first is criminal, and the second is even more criminal. I also know which possibility that I consider more likely.
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Orac writes,
Because I have Google Alerts set up for various terms related to alternative medicine and cancer, I frequently become aware of stories about alternative medicine cancer cures.
MJD says,
I've been asked to submit a research article for publication.
However, the research article is related to alternative medicine and cancer.
A brief summary of the research article follows. (Note that certain words have been removed in the summary to avoid being permanently placed into RI automatic moderation :-)
The naturallergy-oncology perspective described herein explores how forced immunity to allergens from _____ may inhibit tumor growth and metastasizing. The over expression of mast cells and proteins from the Rho family of GTPases has been shown to manifest in multiple types of cancer. ______ is an allergen from _______ that has structure homology with members of the Rho family of GTPases. Forced immunity to _____ may provide IgE-primed mast cells that cross-react with members of the Rho family of GTPases, based on structure homology, and affect angiogenesis in tumors. Research efforts should be directed at exploring if forced immunity to ______ allergens can be used as a supplementary-treatment to inhibit tumor growth and metastasizing.
@Orac,
Once published, will you use the same RI zeal that was used in a a previous posting?
http://scienceblogs.com/insolence/2011/05/10/anti-vaccine-contortions-t…
Or,
Can a forward thinking alternative-medicine approach possibly become a viable therapeutic-intervention to inhibit the progression of cancer?
Please advise and minion comments are welcome...
Which is how private insurers, who play a supplemental role in the UK and a similar role to the NHS in the US, would be expected to deal with the issue. The difference is that with the NHS it's a faceless government bureaucrat, not a faceless corporate bureaucrat, who is saying no.
My understanding from the west side of the pond is that the NHS has its problems, but it generally does a good job of providing basic care. I'm sure Orac's UK readers will have their opinions, which would be relevant here.
As someone living in the UK (and formerly the Netherlands) I'd say that government-provided healthcare like the NHS is usually pretty good, and if anything is too likely to allow treatments that are too costly for their effect. Definitely orders of magnitude better than the US's system where there's a good chance you need to sell one kidney on the black market to pay for fixing the other one with surgery. If anything, we here in west Europe need the governments to get their metaphorical heads out of their asses and actually look at reducing costs by not spending tons on stuff that doesn't work or doesn't work well. Sad to hear about Germany. They're usually considered the saner bunch of the continent... weird how different countries have such different flavors of nonsense somehow.
As for MJD's latest... musings... is it just me or does that sound like it's all theory, assumptions and what-ifs without any actual facts? Based on that summary I doubt we're going to see experimental results showing exposure to I-can't-believe-it's-not-latex-no-really resulted in altered angiogenesis in, say, mouse models.
Proof first, panic second.
In the words of the great philosopher Minchin -
Bring proof and you won't have to call it "alternative".
It's relling that MJD supposed has been asked to write a "research" article - not to report on the results of completing any actual research. The effects of the gamma rays on the man-in-moon marigolds is sure to be rivetting.
The usual name for such a thing in the scientific world is "review article". Such articles can be useful, as their goal is to summarize the current state of research on the topic of the paper, and normally contain a reasonably complete list of recent references on the topic. But in MJD's case, I think it's more likely to be GIGO.
unfortunate mjd sidetracks another good topic to garner attention for himself..again
I found the paper about phase 1b clinical trial of Merck's checkpoint inhibitor interesting, since I am used to phase 1's being mostly about dose finding. But there's no dose finding going on there, just peeking at efficacy. Perhaps it's like the trend of having multiple "expansion cohorts" in phase 1's that I sometimes think should be conducted and powered as phase 2's. I'm writing to see if there's someone who can teach me (us) more about this. Yes, I'm selfish.
Why is it that quacks, who are so fearful of "chemicals", always seem to recommend treating patients with things I'd handle with great caution, very, very carefully, if at all, in a lab?
Hyperbaric oxygen: everyone knows that high concentrations or pressures of oxygen can have serious, even fatal, effects. Oxygen is a neurotoxin at high enough partial pressure, and watch out for spontaneous combustion, a not inconsiderable possible side effect.
Ozone: deadly, very toxic, high explosive. Not even safe to store in a tank, it must be generated and used on the spot. Corrosive to cells, it is the white component of smog, and kills lung tissue if you inhale enough on high smog-index days.
Hydrogen peroxide, injected directly into the body: it is a strong oxidizing agent, kills and damages cells, and in high enough concentration it is a high explosive (in fact, rocket fuel).
EDTA and other chelation agents: fatal at high concentrations.
Halogenated carbon compounds like 3-bromopyruvate and dichloroacetate undoubtedly may be found to have some therapeutic uses, but carbon-chloride bonds are known carcinogens, and halogenated carbons in general are suspected ones. You must wear protective gear when using them, and I certainly wouldn't knowingly expose myself to large doses without them having been shown to have some proven therapeutic effect.
All of these, I would take great care with! But no, the quacks just inject or expose all of these to their patients!
OTOH, quacks will tell you how fearfully dangerous aluminum is, which, due to its strong bonding of oxygen to form an inert solid, is probably not very biologically active in aqueous media, like blood or a cell. And we don't fret much about handling it in a lab.
You best know what you're doing when exposing your "patients" to chemicals. Just any old thing that sounds good is probably something that actual chemists would shy away from.
Why be so hard on bromopyruvate? It sure beats gemcitabine.
A team of scientists at Yale published a series of experiments on bromopyruvate in 2014. They used a novel technique of encapsulating bromopyruvate in cyclodextrin. This is a neat trick to keep to bromopyruvate from reacting before it reaches the cancer cells.
They induced cancer in 42 rats and injected them with with either bromopyruvate, cyclodextrin-encapsulated bromopyruvate, gemcitabine, or cyclodextrin (control). The results were astounding.
The tumor progression was visualized by luciferin bioluminescence, and the images were superimposed over grayscale photographs in Figures 4 and 5. You can plainly see that the encapsulated bromopyruvate completely halted the progression of the tumors while gemcitabine wasn't much better than the control injection (cyclodextrin).
There are eosin-stained histological sections for those interested, and they also proved efficacy in vitro.
Here is a quote:
This is only one out of several experiments showing the efficacy of bromopyruvate on cancer via the Warburg Effect.
Systemic Delivery of Microencapsulated 3-Bromopyruvate for the Therapy of Pancreatic Cancer
@Garnetstar
Hydrogen Peroxide is made by macrophages to destroy invaders. We are all producing hydrogen peroxide in our bodies right now.
But not as explosive as nitroglycerin; an high-explosive used by mainstream cardiologists.
But nothing can outdo Lentonitrat. This cardiac drug is mostly pentaerythritol tetranitrate, one of the most powerful explosives known to man.
PETN (Lentonitrat) has a detonation velocity of 8,400 m⁄s. This is faster than TNT's and just short of RDX's.
The mainstream medical doctors prescribe much higher explosives than "the quacks".
@Garnestar
Really? Calcium EDTA has an LD₅₀ of 2g/kg in rats.
I challenge you to find one patented pharmaceutical drug that has a lower LD₅₀.
http://www.sciencelab.com/msds.php?msdsId=9923899
MJD says,
I’ve been asked to submit a research article for publication.
Check the source of the invitation against Jeffrey Beall's list of predatory journals.
Another powerful study on bromopyruvate was done at Johns Hopkins and published in 2012. In this experiment, the researches used luciferin bioluminescence for in vivo analysis of experimentally-induced rat lymphoma.
The results are striking. The bioluminescent images are presented in Table 4 and show a marked reduction of tumor growth over the control group. Fig 3a shows the effect of daily injections of bromopyruvate, and Fig 3b shows the slight reduction of a one-time dose on day one of treatment.
The results indicate that daily injections of bromopyruvate significantly inhibits tumor growth over controls. Here is a quote:
Systemic administration of 3-bromopyruvate in treating disseminated aggressive lymphoma
NIKLAUS G. SCHAEFER
JEAN F. GESCHWIND
JAMES ENGLES
JULIA W. BUCHANAN
RICHARD L. WAHL
The most comprehensive and powerful study done on bromopyruvate was published in 2008 by The Journal of Pharmacology and Experimental Therapeutics. This study used rabbits and four dosage groups.
The experimenters used ¹⁴C-labeled bromopyruvate in addition of ¹⁸F-labeled fludeoxyglucose to measure tumor glycolysis. One group of rabbits were given ¹⁴bromopyruvate via the left hepatic artery, two groups were given different doses intravenously, and one group was given saline.
This also included a small survival study. There are no PET images to see, but Figure 2 graphs the tumor uptake of ¹⁴bromopyruvate and Figure 3 illustrates how bromopyruvate blocks the glycolysis of ¹⁸fludeoxyglucose in the tumor.
Figure 4 shows the 269% increase in survival for bromopyruvate-treated rabbits, and Figure 6 is an eosin-stained slide illustrating the non-toxicity of bromopyruvate on non-cancerous liver tissue.
I will let the others summarize the rest, since they do a fine job at this:
The selective uptake is evident by the data. The tumors incorporate more bromopyruvate than health tissue. Radio-labeled bromopyruvate allowed them to test this effect. Bromopyruvate beats doxyrubicin in this regard as well as in it's toxicity profile.
This is significant. I'll have what they're having.
They also decided to retain a very small group of three rabbits indefinitely. They achieved one cure:
Targeting of VX2 Rabbit Liver Tumor by Selective Delivery of 3-Bromopyruvate: A Biodistribution and Survival Study
Mustafa Vali, Josephina A. Vossen, Manon Buijset al
Katie, you may think you're adding something meaningful to this discussion, but you are not. Orac even acknowledged that bromopyruvate is a promising drug.
The complaint was never that bromopyruvate is a quack alternative drug that never works - the complaint is that patients are being charged exorbitant prices for bromopyruvate for the treatment of cancers it has never been tested in.
We're all fans of research, and we all hope bromopyruvate is proven to help more and more types of patients. But Orac, myself, and many regulars to this blog hate and detest "doctors" who make false promises to patients and then bankrupt them chasing experimental treatments.
Your points about medical explosives are true, but also irrelevant. The key is the cost/benefit analysis. Yes, nitroglycerin is explosive, but not at the concentrations used in medicine, and has actual medical benefits.
Ozone has no medical benefits to speak of (aside from use as a disinfectant in the distant past), so any amount of risk is unacceptable.
@Bob
No shiτ. Couldn't you see that I was merely refuting Garnestar's mention that hydrogen peroxide is explosive. His implication seemed to be that explosive compounds have no place in medicine.
Are you implying that hydrogen peroxide has no medical benefits?
And what have you added you twerp? You have not added anything remotely meaningful. I presented the three most promising studies on bromopyruvate, and they all showcase it's powerful ability to inhibit cancer. Bromopyruvate is safer and more effective that gemcitabine.
If that isn't relevant to a discussion on bromopyruvate then I don't know what is.
All of the rest of you merely lob insults at anything remotely "alternative", as if the FDA should have the final say in what constitutes a therapeutic treatment.
I have a hard time believing that patients are charged hundreds of thousands of dollars for bromopyruvate. You can buy it for about $10/g from Sigma-Aldrich. You are going to need a citation for these outrageous claims.
http://www.sigmaaldrich.com/catalog/product/aldrich/16490?lang=en®io…
3-Bromopyruvate (3BP) a fast acting, promising, powerful, specific, and effective "small molecule" anti-cancer agent taken from labside to bedside: introduction to a special issue.
The people I know that have gone this route either exhausted their conventional options or their own patience after 1+ years and iatrogenic injury within the English speaking, conventional medical systems.
All the people were within the top 1-5% intelligence wise, and had their own earned funding. I would estimate their expenditures comparable to the US - probably less than CTCA and maybe perhaps about MSKCC or less, allowing for taxes. Although I've learned 1-2 tricks watching e.g. a biomarker and a little about it's logic, mostly I reassure myself that I haven't missed consideration of some important unknown option(s).
From my perspective, perhaps these clinics are too "oncological" in going to MTD with some treatments that they do. They are not careful and consistent enough in application for my taste. They are well outside my budget. A techie might even do better at home than any of the institutions including the US ones, outside of ER, surgery, scans or super specialty tx.
This is just another ill informed diatribe on vitamin C. With IV vitamin C, cancer patients often get 1-7 good days from their miserable existence - a sprayed and kicking cockroach is my mental image of some maimstream patients' situation without it. The one day being more representative of someone with 80-90% liver replacement by cancer.
Probably more intricate is to get oral and IV vitamin C to consistently function as an additive adjunct to some chemo formula. Perhaps not simple enough for some amateur with an MD, a bias, and an attitude.
Hi Katie,
I don't know how much alt-med patients pay for bromopyruvate, but I doubt they're straight up injecting what they buy from Sigma. We see figures of patients spending £30,000-300,000 on treatment protocols that include this drug, but the quacks don't give us an itemized bill, so in principle I don't know that they were stiffed on the bromopyruvate, something else, or everything.
And again with the animal studies - why do you keep bringing this up? The FDA puts a higher bar on drugs for a reason: people have fucking *died* from clinical trials, not to mention how many drugs with promising effects in animal models wound up being dangerous or ineffective in humans compared to existing standard of care (re: most of them).
Beyond concern for the medical and financial safety of patients, there is also the tangential issue of quacks advertising that any drug or treatment will cure a patient's cancer when the evidence is either non-existent, confined to animals, or only pertains to a different disease.
It sounds like you have a bone to pick with the FDA, or perhaps the scientific-medical community in general, since the subject of the this article was treated in the UK and Germany.
So how would you like things to be? Should doctors be allowed to prescribe any drug based on pre-clinical studies? Should insurers be forced to pay for it? You might want to look up John Ioannidis.
Or is this just a "health freedom" thing? In that case, I'd ask a similar set of questions: Should doctors be allowed to advertise drugs as working based solely on pre-clinical studies? Should insurers be forced to pay for a patient exercising his freedom to take unproven drugs?
The people I know that have gone this route either exhausted their conventional options or their patience after 1+ years and iatrogenic injury within the English speaking, conventional medical systems.
All the people were within the top 1-5% intelligence wise, and had their own earned funding. I would estimate their expenditures comparable to the US – probably less than CTCA and maybe perhaps about MSKCC or less, allowing for taxes.
Although I’ve learned 1-2 tricks watching e.g. a biomarker and a little about it’s logic, mostly I reassure myself that I haven’t missed consideration of some important unknown option(s).
From my perspective, perhaps these clinics are too “oncological” in going to MTD with some treatments that they do. They are not careful and consistent enough in application for my taste. They are well outside my budget. A techie might even do better at home than any of the institutions including the US ones, outside of ER, surgery, scans or some super specialty treatment.
------------
This is just another ill informed diatribe on vitamin C. With IV vitamin C, cancer patients often get 1-7 good days from their miserable existence – a sprayed and kicking cockroach is my mental image of some maimstream patients’ situation without it. The one day being more representative of someone with 80-90% liver replacement by cancer.
Probably a little more intricate is to get oral and IV vitamin C to consistently function as an additive adjunct to some chemo formula. Perhaps not simple enough for some amateur with an MD, a bias, and an attitude.
The Young Ko article mentioned above is very interesting. He achieved a 100% success rate (n=19) with bromopyruvate in mice. He injected them with carcinoma cells. The article can downloaded here and is full of lovely color photographs:
Advanced cancers: eradication in all cases using bromopyruvate therapy to deplete ATP
Just click on the "Download .pdf" button!
A few quotes from the article:
He gave them cute names...and then he injected them with rapidly proliferating carcinoma.
But it has a happy ending...
Sounds cool. What about the ones on their backs?
Figure 7a has cute pics of all the surviving mice!
I have a hard time believing that patients are charged hundreds of thousands of dollars for bromopyruvate. You can buy it for about $10/g from Sigma-Aldrich. You are going to need a citation for these outrageous claims.
Here's someone trying to collect $18000 for a course of treatment. But that sounds like the patient hopes for treatment from Vogl, using TACE, which is sufficiently invasive, hi-tech and skill-dependent to justify the price.
I have a hard time believing that patients are charged hundreds of thousands of dollars for bromopyruvate
Katie, you may be misreading Orac's statement that "Pauline Gahan spent £300,000" (by her own account). That was not just for 3BP; it was for Keytruda immunotherapy, bespoke synthesised vaccines, and heaven know what else.
(I thought I sent this message before, but it didn't make it through)
Hi Katie,
I don't know why you keep bringing up animal trials of bromopyruvate. And no, it's not relevant to discussion, because Orac acknowledges that bromopyruvate is a promising cancer treatment that deserves further study.
No, the controversy is over the fact quack doctors are already advertising and selling 3-BP, claiming it will cure patients' cancers, despite the absense of clinical trials proving its safety and effectiveness in humans. No number of animal studies is going to make that problem go away.
As for the price, all I know is that quacks are charging £30,000-300,000 for a course of treatment that includes 3-BP. I haven't seen anyone published an itemized receipt, so in principle I can't know how much of that amount is 3-BP and how much is aspects of the treatment.
So, what exactly is your problem with the FDA, especially considering this case involves the UK and German health authorities? Do you think doctors should be allowed to advertise and sell drugs based solely on animal studies, drugs that have not gone through the clinical trial process? Do you think public or private health insurers should be forced to pay for experimental treatments?
Or maybe this is a health freedom thing, everyone should get to have any treatment they want? Well, in that case, do you still think it's OK for a doctor to advertise a drug as effective when there are no human clinical trials to support that claim? If you think promising preclinical trials suffice, you may want to read some of John Ioannidis's work. Most drugs that show promise in preclinical and early-phase clinical research ultimately fail to prove safe and effective compared to standard of care. And that's why the FDA insists on the clinical trial system.
Hi, Fucklesworth.
@ Katie Schreiber
Oh for Pete's sake.
Reactive oxygen species (ROS) are created all the time by phagocyte cells, true enough, but they are produced in a specialized organelle inside the cells, and carefully applied to the phagocyted invaders.
They are also occasionally released at the surface of infected cells, and in this case the targeted cells are expected to die. A strong inflammation and lots of tissue damage are the result of such a release (granted, there are other participating molecules being released at the same time).
They never reach locally the quantities you will reach by injecting the product straight from a syringe.
FTFY while my previous comment is deliberately in moderation.
bulshit. just replace "ALTERNATIVE" to "conversional" word and you get same results - all conversional clinics are quackers. they dont cure! it takes 10 and more years to accept drug . think cancer patient must stay at home and die? do dead people needs money? they need hope and a chance. thats why they are going to another direction. athtor is fu... moron . i wish you have cancer and we'LL see what you will do...
dm, I think you're flying a little bit off the handle when the article is describing how people looking for hope and chance get taken advantage of, with treatments that cannot support an evidence-based benefit and are outside of a rational approach to fighting a disease to begin with. Not everything is a 10 year process to see a trial result that won't work, and creates harm. The article shows the opportunism, taking advantage of people in their worst moments of their life.
I get frustrated at the uncritical reporting of these alternative clinics, no reporter digs into whether the costs are reasonable or makes any attempt at meaningful comparisons to standard care. They are happy with the usual uncaring bureaucracy vs plucky patient story arc. This goes for $10K for antibiotics for ChronicLyme to $100K for cancer "cures". The assumption appears to be that magic is supposed to be expensive.
Katie,
It is fascinating how chemicals can have other uses, isn't it? The one that surprised me when I learned about it was medicinal hydrazine. Hydrazine sulfate is used as a chemotherapy agent. And other forms of hydrazine --particularly monomethyl hydrazine (MMH) and unsymmetrical dimethyl hydrazine (UDMH) -- are used as rocket propellant. It has three great advantages. One is that its density isn't too shabby*, another is that it is stable and storable over long periods of time (provided you don't let it freeze), and the last is that it is hypergolic with nitrogen tetroxide (N2O4). N2O4 is also conveniently storable, and the hypergolic nature of the mixture means they spontaneously ignite on contact, so it's a much simpler ignition system. Unfortunately, both hydrazine and N2O4 are quite toxic; the US has completely eliminated the use of them in first or second stage rockets, but alas, there is no suitable alternative for most spacecraft rocket applications. Voyager 1 still has a supply of MMH monopropellant**, loaded in the 1970s and still good today; the spacecraft occasionally uses a bit to maintain its proper orientation.
*this is the main problem with liquid hydrogen -- although chemically pretty much the ideal fuel, the density is atrociously low, necessitating enormous tanks
**as a monopropellant, it is allowed to flow past a catalyst that triggers it to decompose violently into ammonia, nitrogen, and hydrogen. H2O2 got mentioned earlier in this thread; that is one of the ways it has been used as a propellant as well -- it is induced to decompose by passing it over a catalyst. However, it is far less convenient than hydrazine.
Eric @2
As a retired NHS employee, it was long my opinion that the main problems with our ability to provide healthcare fall into the following groups:
constant political interference, resulting in restructuring after reorganisation after organisational change, which wastes limited resources on things which are never evaluated nor given time to see if they might work and have no relevance to clinical services anyway;
deliberate limiting of funds or cutting funds by Conservative governments (someone recently FOI'd some info about how my bit of the forest - MH - had been hacked to bits since May 2010);
poor commissioning of services (my bit of MH was commissioned for years by folk who had no idea about it and wrote ridiculous contracts);
the cult of managerialism, which means that unsuitable managers are given more power and say than any clinician in what is done and how.
Oh, and I should repeat what I've said before that the bulk of the UK media (owned by foreign-born or foreign, i.e. tax exile, resident billionaires) have long had an ideological objection to the NHS and these sorts of stories are a means of driving their narrative about the NHS failing.
Don't forget that according to Crislip's Law, that for every scam, there is an equal and opposite scam. In this case, it's antioxidants. Eat enough of them, and all those problems and more will go away.
/sarcasm
Orac:
Its for sure
Removab (Catumaxomab), not that vet drug!
regards, Mic (from Germany)
in your article you mentioned the names of my doctors: Dr Ursula Jacob and Dr Kopic. They are not quacks in any way, Dr Kopic received my cousin with stage 4 brain tumor sent home from treatment in america with no hope, she was blinded in one eye from an inoperable growing tumor. she is cured now with all the methods you criticize. no surgery, her blood is cancer clear, tumor died and is gone; it shrunk to death. and her eye is not blind any more, also my Aunt is no longer diabetic and needs no medication. I am cancer free now. Go see the people walking healthier than ever expected that these doctors have treated, you will be shocked, ask for these doctors statistics, you will be shocked. soon this kind of cancer treatment will be worldwide and affordable to all. this article seems an attack without proper research of those who's lives were saved and extended way beyond expected. why would so many educated people go for these treatments if they don't work ? ask the sick who have been cured of so much not just cancer. the numbers will astound you. yes it is expensive (for now) (your article does not help) And articles like this will cause the death or suffering of people who could have been living illness free and cancer cured. if they believed it. This article kills hope of a very valid treatment method and names doctors that have saved so many no hope people. it is a disgrace, bad research online without statistics or examples of the cured. not a well researched article, one sided and ignorant due to the lack of information from those who have been saved by these doctors. it is sad and cruel. please look into it further from the view point of the people being treated. Be professional the thorough in the information you research. Get on a plane and go see, the doctors wont say no. ask for cases and talk to the people they have cured. Get your facts, not your opinion and flimsy research. thank you