Archive for Cancer

German alternative cancer clinics: Combining experimental therapeutics with rank quackery and charging big bucks for it

Pauline Gahan in front of the Hallwang Private Oncology Clinic
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.

Posted in: Cancer, Clinical Trials, Health Fraud

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Mammography and overdiagnosis, revisited

Reading mammograms
[Editor Note: This is a greatly expanded version of my initial thoughts on a study about mammography published in the New England Journal of Medicine last week on my not-so-super-secret other blog. It’s such an important topic that I thought SBM should see my discussion too, and I couldn’t just cut and paste it. You deserve original material.]

I knew it. I just knew it. I knew I couldn’t get through October, a.k.a. Breast Cancer Awareness Month, without a controversial mammography study to sink my teeth into. And I didn’t. I suppose I should just be used to this now. I’m referring to the latest opus from H. Gilbert Welch and colleagues that appeared in the New England Journal of Medicine last week, “Breast-Cancer Tumor Size, Overdiagnosis, and Mammography Screening Effectiveness.” Yes, it’s about overdiagnosis, something I’ve blogged about more times than I can remember now, but it’s actually a rather interesting take on the issue.

Before 2008 or so, I never gave that much thought to the utility of mammographic screening as a means of early detection of breast cancer and—more or less—accepted the paradigm that early detection was always a good thing. Don’t get me wrong. I knew that the story was more complicated than that, but not so much more complicated that I had any significant doubts about the overall paradigm. Then, in 2009, the United States Preventative Services Task Force (USPSTF) dropped a bombshell with its recommendation that mammographic screening beginning at age 50 rather than age 40 for women at average risk of breast cancer. Ever since then, there have been a number of studies that have led to a major rethinking of screening, in particular screening mammography and PSA testing for prostate cancer. It’s a rethinking that affects discussions even up to today, with advocates of screening arguing that critics of screening are killing patients and skeptics of screening terming it useless. Depending on the disease being screened for, the answer usually lies somewhere in between. Basically, screening is not the panacea that we had once hoped for, and the main reason is the phenomenon of overdiagnosis. Before I go on, though, remember that we are talking about screening asymptomatic populations. If a woman has symptoms or a palpable lump, none of this discussion applies. That woman should undergo mammography.

Posted in: Cancer, Public Health

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Is there a distinct standard of care for “integrative” physicians? The Woliner case

Board certification in family medicine and "integrative" medicine: different standards of care?

Board certification in family medicine and “integrative” medicine: different standards of care?

Florida Atlantic University student Stephanie Sofronsky was diagnosed with Hodgkin’s lymphoma in 2011, after review of her case by oncologists and pathologists at Moffitt Cancer Center in Tampa, the NIH/National Cancer Institute, and the Mayo Clinic in Jacksonville. By June of that year, a PET scan showed the cancer had progressed to her pelvic region. She decided to be treated locally by oncologist Neal Rothschild, MD, and met with him to discuss chemotherapy and ongoing management of her cancer. At this point, with Stage III Hodgkin’s lymphoma, she had an 80-85% chance of being in complete remission with appropriate treatment.

Unfortunately, at the same time, Sofronsky was also seeing Kenneth Woliner, MD, a family medicine practitioner. Despite the fact that world-renowned cancer specialists agreed that Sofronsky had Hodgkin’s lymphoma, and knowing that she was about to start chemotherapy, Dr. Woliner told Sofronsky that cancer was “low on his list” of possible medical concerns and that increased lymphoctyes shown in her tests were not indicative of cancer, insinuating that oncologists “often overreact” to the presence of lymphocytes and recommend chemotherapy before making an actual diagnosis. Dr. Woliner suggested instead that Sofronsky have her house tested for mold, which could be causing allergies, and therefore her symptoms. Convinced, Sofronsky pursued treatment for her allergies and cancelled her follow-up appointment with Dr. Rothschild.

Sofronsky complained repeatedly to Dr. Woliner of symptoms that were, as our good friend Orac points out, consistent with progressing lymphoma – back pain and pain and swelling in her lymph nodes, abdomen and legs, to the point of having to use a cane. Yet, Dr. Woliner, over the next couple of years, continued to attribute her symptoms mostly to her allergies and also thyroid issues and some other minor illnesses. On February 7, 2013, at her last visit to his office and in significant distress from pain and severe leg swelling, he ordered a 100 mg shot of iron, despite the fact that her blood tests showed she was not iron deficient. She rapidly decompensated and died in the hospital three days later of from complications of untreated Hodgkin’s lymphoma. (more…)

Posted in: Cancer, Ethics, Health Fraud, Herbs & Supplements, Legal, Politics and Regulation

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When science- and evidence-based guidelines conflict with patient wishes: What’s a doc to do?

Evidence-based medicine triad

There’s a misconception that I frequently hear about evidence-based medicine (EBM), which can equally apply to science-based medicine (SBM). Actually, there are several, but they are related. These misconceptions include the idea that EBM/SBM guidelines are a straightjacket, that they are “cookbook medicine,” and that EBM/SBM should be the be-all and end-all of how to practice clinical medicine. New readers might not be familiar with the difference between EBM and SBM, and here is not the place to explain the difference in detail because this post isn’t primarily about that difference. However, for interested readers, a fuller explanation can be found here, here, here, and here. The CliffsNote version is that EBM fetishizes the randomized clinical trial above all other forms of medical investigation, a system that makes sense if the treatments being tested in RCTs have a reasonably high prior probability of translating to human therapies based on basic science mechanisms, experimental evidence in cell culture, and animal experiments. Using Bayesian considerations, when the prior probability is very low (as is the case for, for example, homeopathy), there will be a lot of false positive trials. Such is how EBM was blindsided by the pseudoscience of “complementary and alternative medicine” (CAM) or, as it is called now, “integrative medicine.”

However, for purposes of this post, SBM and EBM can be considered more or less equivalent, because we are not going to be discussing CAM, but rather widely accepted treatment guidelines based on science, both basic and clinical trial science. I merely mention this difference for completeness and for new readers who might not be familiar with the topics routinely discussed here. For purposes of this post, I’m talking evidence-based guidelines from major medical societies. More specifically, I want to address the disconnect between what patients often want and what our current guidelines state. It’s not just patients either, but doctors; however, for purposes of this post I’m going to focus more on patients. It’s a topic I’ve addressed before, in particular when it comes to breast cancer, where I’ve discussed changes in the mammography screening guidelines and Choosing Wisely guidelines for breast cancer. There are many other examples that I haven’t discussed. (more…)

Posted in: Cancer, Diagnostic tests & procedures

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Infectious Diseases and Cancer


Dr. William Coley. Not a brain surgeon.

With apologies to my colleagues, but infectious diseases really is the most interesting specialty in medicine. There are innumerable interesting associations and interactions of infectious diseases in medicine, history, art, science, and, well, life, the universe and everything. ID is so 42.

A recent email led me to wander the numerous interactions between infections and cancer.

There are the cancers that are caused by infection. HPV and cervical and throat cancer. EBV and lymphoma. HHV8 and Kaposi’s Sarcoma. I certainly hope I am not reincarnated as a Tasmanian Devil. (more…)

Posted in: Basic Science, Cancer, Clinical Trials, Epidemiology, Science and Medicine, Vaccines

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Personal Care Products Safety Act: Facelift for FDA Regulation or Lipstick on a Pig?

Ad from the 1930s, when cosmetics regulation was last addressed by Congress.

Ad from the 1930s, when cosmetics regulation was last addressed by Congress.

The U.S. cosmetics industry, the largest in the world, is expected to reach $62 billion in revenues in 2016. Yet, despite the fact that its products are regularly applied to, and absorbed by, the body’s largest organ (the skin) and even ingested in small amounts, the cosmetics industry is largely self-regulating.

There are over 57,000 different chemicals used in cosmetics. According to one research report, on average, women use 12 personal care products every day, exposing themselves to 168 chemical ingredients. Men use about half that, but still expose themselves to 85 unique chemicals a day. Many of these may be perfectly safe, we just don’t know which ones because most have not been tested for safety.

Increasing concerns about everything from contact dermatitis to carcinogens led Senators Dianne Feinstein (D-California) and Susan Collins (R-Maine) to introduce the Personal Care Products Safety Act, giving the FDA greater regulatory oversight of the cosmetics industry. The Senate Committee on Health, Education, Labor & Pensions held a hearing, “Exploring Current Practices in Cosmetic Development & Safety” last Thursday. A similar bill has been introduced in the House of Representatives. At least one other House bill was introduced in 2013 attempting to strengthen FDA regulatory authority over cosmetics, but it went nowhere. (more…)

Posted in: Cancer, Legal, Politics and Regulation

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Diet and exercise versus cancer: A science-based view

Exercise time

One of the most effective spin techniques used by advocates of “integrative medicine” (also sometimes called “complementary and alternative medicine,” or CAM for short) to legitimize quackery has been to claim basically all non-pharmacologic, non-surgical interventions as “integrative,” “complementary,” or “alternative.” Thus, science-based interventions such as diet changes to treat and/or prevent disease, exercise, and other lifestyle alterations are portrayed as somehow so special that they need their own specialty, “integrative medicine,” even though they are simply part of medicine. I pointed this out a mere two weeks ago when I discussed the National Center for Complementary and Integrative Health (NCCIH) review of non-pharmacological treatments for pain. It was a systematic review that was essentially negative but spun as positive for some interventions and lacked some key analyses that a good systematic review includes, such as assessment of the quality of the studies included and evaluating them for bias.

Such were my thoughts over the weekend as I got into a Twitter exchange with an advocate of integrative medicine who was touting the benefits of diet as a cancer preventative and how a course in nutrition “opened her eyes.” That in and of itself wasn’t particularly annoying, although I strongly suspect that the nutrition course she took was not given by actual registered dietitians or other experts in science-based nutrition (she wouldn’t say when questioned). What was annoying is that she trotted out some tropes beloved by integrative medicine proponents, such as the claim that most doctors don’t do prevention because they get paid to treat. She was called out for it:

Oddly enough, on the same day a post from the American Society of Clinical Oncology (ASCO) came up in e-mail lists that discussed the actual evidence for the utility of diet and exercise for cancer prevention. It’s almost as though Twitter were telling me it was time for me to discuss this issue from a science-based perspective. So I will attempt to do so.

Posted in: Cancer, Epidemiology, Nutrition

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The Cancer Moonshot: Hype versus reality

Joe Biden promotes the Cancer Moonshot initiative.

Joe Biden promotes the Cancer Moonshot initiative.

The Cancer Moonshot. It’s a topic that I’ve been meaning to address ever since President Barack Obama announced it in his State of the Union address this year and tasked Vice President Joe Biden to head up the initiative. Biden, you’ll recall, lost his son to a brain tumor. Yet here it is, nearly eight months later, and somehow I still haven’t gotten around to it. The goal of the initiative is to “eliminate cancer as we know it,” and to that end, with $195 million invested immediately in new cancer activities at the National Institutes of Health and $755 million proposed for FY 2017. My first thought at the time was that that wasn’t nearly enough money to achieve the ambitious goals set out by the President. That has now become particularly clear now that the National Cancer Institute has released the report from the initiative’s blue ribbon panel suggesting ten ways to speed up progress against cancer.

Posted in: Basic Science, Cancer, Clinical Trials, Politics and Regulation

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3-Bromopyruvate: The latest cancer cure “they” don’t want you to know about

3-BP: A "safe" and "nontoxic" cancer cure targeting the Warburg effect that quite possibly killed three cancer patients in Germany.

3-BP: A “safe” and “nontoxic” cancer cure targeting the Warburg effect that quite possibly killed three cancer patients in Germany.

I’ve not infrequently written about various dubious and outright quack clinics in different parts of the word with—shall we say?—somewhat less rigorous laws and regulations than the US. Most commonly, given the proximity to the US, the clinics that have drawn my attention are located in Mexico, most commonly right across the border from San Diego in Tijuana for easy access by American patients. Sometimes, in the case of dubious stem cell clinics, they are located in countries like China, Argentina, or Kazakhstan. That’s not to say that there aren’t a lot of quack clinics right here in the US (particularly for stem cell treatments), but, by and large, the clinics doing the truly dangerous stuff tend to be less common in the US.

There is, however, another country where alternative medicine clinics, particularly for cancer, are common and thriving, specifically Germany. I first learned of these clinics when the story of Farrah Fawcett’s battle with anal cancer hit the news nine years ago. Ultimately, she died of her disease at age 62, but before she did she sought treatment at a clinic in Germany, which administered alternative treatments as well as radioactive seed implants, the latter of which, despite sounding nice and “conventional,” were not standard-of-care for recurrent anal cancer. What this led me to learn is that German alternative cancer clinics tend to use both alternative medicine and experimental “conventional” medicine that has not yet been shown to be safe and effective in clinical trials.

I thought of Farrah Fawcett when news about a German cancer clinic hit the news again beginning more than a week ago, when two patients from the Netherlands and one from Belgium died shortly after having undergone treatment at the Biological Cancer Centre, run by alternative practitioner Klaus Ross in the town of Brüggen, Germany. Two others were hospitalized with life-threatening conditions. I didn’t blog about them at the time because the only reports I could find were those sent to me by readers, and they were in German or Dutch. They also didn’t have a lot of detail. Both reported that on July 25, a 43-year-old Dutch woman went to the Biological Cancer Center in Brüggen-Bracht for treatment of breast cancer and that she unexpectedly died on July 30 of unknown causes. The Dutch report stated that the death occurred under mysterious circumstances and that there were two other deaths, that of a Belgian woman the week before, and a Dutch man.

Elsewhere, Irish newspaper reports:

Dutch police, who are supporting the inquiry, appealed for information from other patients, as newspapers reported the clinic had been using an experimental transfusion.

Concern was first raised when a 43-year-old Dutch woman with breast cancer complained of headaches and became confused after being treated at the clinic on 25 July.

She later lost the ability to speak, and died on July 30 although the “cause of her death remains unclear,” the German prosecutors said in a statement earlier this week.

Later, it was learned that the identities of the suspected victims were Joke Van der Kolk, age 43; Leentje Callens, age 55; and Peter van Ouwendorp, age 55.

Unfortunately, the early reports were fairly basic, without much detail, and only a couple with any names. Fortunately, now there is an article in Science that reports more. It turns out that the suspected cause of death is an experimental cancer drug known as 3-bromopyruvate (3-BP) that has not yet been approved for use in humans. So what happened?

Posted in: Basic Science, Cancer, Clinical Trials, Health Fraud

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The ROCA Screening Test for Ovarian Cancer: Not Ready for Prime Time

Ovarian cancer

Ovarian cancer

Ovarian cancer is relatively rare but deadly. The lifetime risk of ovarian cancer is 1.5% compared to 12% for breast cancer, but it is the 5th most common cause of cancer death for women. Since the ovaries are hidden deep in the pelvis and the symptoms of ovarian cancer are non-specific, the cancer is often advanced by the time it is diagnosed and survival rates are low. Early detection by screening would be expected to improve outcomes. Two screening methods have been proposed: the cancer antigen CA-125 blood test, and pelvic ultrasound. The Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO) found that screening with CA-125 and ultrasound did not reduce ovarian cancer mortality. The USPSTF recommends against screening for ovarian cancer because it does not reduce mortality and carries important potential harms from false positives and unnecessary surgeries.

Ovarian cancer screening is being re-considered in the light of a recent study, the UKCTOCS trial, published in The Lancet in December 2015. On the basis of that study, a test called ROCA is being offered directly to the public for $295. It’s important to understand what the study actually found, and why experts have questioned the wisdom of offering this test to the public at this time. (more…)

Posted in: Cancer, Diagnostic tests & procedures

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