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Archive for Clinical Trials

High dose vitamin C and cancer: Has Linus Pauling been vindicated?

ResearchBlogging.orgTHE ZOMBIE RISES AGAIN

Vitamin C as a treatment for cancer is back in the news again.

I’m not surprised. This is one therapy favored by advocates of “alternative” medicine that keeps popping up periodically (seemingly every couple of years or so). This latest bit of news has turned up almost right on time after the last time there was a push for rehabilitating vitamin C as a cancer cure a couple of years ago. Back in the spring of 2006, there were two studies published (more on them later) which were touted by the “complementary and alternative medicine” (CAM) crowd as evidence that Linus Pauling was supposedly vindicated. A little less than two weeks ago, an animal study was published suggesting that high-dose intravenous vitamin C had antitumor activity in mouse models. A couple of weeks prior, there had also been published a phase I clinical trial that showed that megadoses of IV ascorbate were safe and well-tolerated in cancer patients if they were appropriately screened for renal disease. Given the latest studies of this particular modality against cancer, it seemed like an opportune time for me to examine this new evidence and ask the question: Has Linus Pauling been vindicated?

I’ll cut to the chase. The short answer is: Not really, with the qualification that it depends on what you mean by “vindicated.” The long answer follows.
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Posted in: Basic Science, Cancer, Clinical Trials, Nutrition, Science and the Media

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The Orange Man

The first thing that struck me about him was that he was orange.

It was not a shade of orange I had ever ever encountered before in a patient. It was a yellowish orange, an almost artificial-looking color. At first I wondered if he was suffering from liver failure with jaundice, but this orange was just not the right shade of yellow for jaundice, and his sclerae were not yellow. I also considered whether he was suffering from renal failure, but the orange color of his skin didn’t quite match the rather coppery color that some patients suffering from longstanding renal failure necessitating dialysis sometimes acquire. I was puzzled. His chart said that he was being admitted for surgery for rectal cancer. So I sent the intern in to get the story, do the history and physical, and get him all plugged in for his bowel prep. Believe it or not, there was actually a time when it was not all that uncommon for patients to come into the hospital the night before major abdominal surgery in order to undergo a preoperative bowel prep, rather than being forced by their insurance companies to undergo the torture of drinking four liters of the purgative known as Go-Lytely–a misnomer, if ever there was one!–at home and spending the next several hours having to rush periodically to the toilet, waiting in vain for the liquid exploding out of their hind end to run clear.
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Posted in: Cancer, Clinical Trials, Science and Medicine, Surgical Procedures

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Sterile Water Injections for Pain Relief

Before ethical standards changed, doctors used to occasionally fool patients with placebo injections of sterile saline or water. If my obstetrician had tried to give me sterile water instead of an epidural, I probably would have hit him. But apparently women are getting sterile water injections for childbirth and are telling us they work. What’s going on?

A recent study in Sweden compared sterile water injections to acupuncture for relief of labor pain. It found that sterile water produced significantly greater pain relief and relaxation. It concluded, “Women given sterile water injection experience less labor pain compared to women given acupuncture.”

I’m puzzled, because the study also says “there were no significant differences regarding requirements for additional pain relief after treatment between the 2 groups.” 85% and 90% got nitrous oxide, 40% and 47% got epidurals, and other conventional interventions were also used. It seems to me the conclusion could just as well have been “Women given sterile water injections report less labor pain than women given acupuncture, but require just as much additional pain relief.” (more…)

Posted in: Clinical Trials

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HIV Treatment Extends Life Expectancy

ResearchBlogging.org

People with HIV are living longer on the latest anti-retroviral therapy. This is something any infectious disease specialist knows from their own clinical experience – but it’s reassuring (I would even argue necessary) to have objective data to support experience. A study published in the latest issue of Lancet provides this objective data. (Lancet. 2008 Jul 26;372(9635):293-9.)

The press release from Bristol University, academic home of the lead author, says:

Professor Jonathan Sterne of Bristol University’s Department of Social Medicine and Professor Robert Hogg of British Columbia Centre for Excellence in HIV/AIDS and Simon Fraser University, Vancouver, Canada and colleagues from The Antiretroviral Therapy Cohort Collaboration (ART-CC) compared changes in mortality and life expectancy among HIV-positive individuals on cART.

This collaboration of 14 studies in Europe and North America analysed 18,587, 13,914, and 10,584 patients who started cART in 1996-99, 2000-02, and 2003-05 respectively.

A total of 2,056 patients died during the study period, with mortality decreasing from 16.3 deaths per 1000 person-years to in 1996-99 to 10.0 in 2003-05 – a drop of around 40 per cent.

Potential life years lost per 1000 person-years also decreased over the same time, from 366 to 189 — a fall of 48 per cent. Life expectancy increased from 36.1 years in 1996-99 to 49.4 years in 2003-05, an increase of more than 13 years.

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Posted in: Clinical Trials, Public Health

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Cavalcade of Quackery: A Pantomine Horse

Last week I received the news release below that Steve Zeitzew, an orthopedic surgeon at VA Hospital Los Angeles and UCLA, sent to the Healthfraud list. It was sent to me by our colleague Liz Woeckner, President of the nonprofit research protection advocacy organization Citizens for Responsible Care in Research (CIRCARE) http://www.circare.org/
Ms. Woeckner sent it on with a cryptic comment, wondering if this action was a quid pro quo for the Chinese granting less than a dozen FDA “inspection stations” in Chinese cities. The latter is supposed to be an attempt to control the impurities and adulterants of Chinese herbal products.

But before proceeding, read for yourselves:

Monday, June 16, 2008 Contact: HHS Press Office

HHS Secretary and Chinese Minister of Health Sign Memorandum of Understanding on Traditional Chinese Medicine Research .

HHS Secretary Mike Leavitt today signed a memorandum of understanding with Chinese Vice Minister of Health Wang Guoqiang to foster collaboration between scientists in both countries in research on integrative and traditional Chinese medicine. The signing marks the opening of a two-day traditional Chinese medicine Research Roundtable at the National Institutes of Health (NIH). The roundtable features scientific presentations by researchers from China and the United States. Topics include the synthesis of Western medicine and traditional Chinese medicine, criteria for evaluating traditional Chinese medicine practices, and the application of modern scientific tools such as proteomics (the study of proteins) to the study of traditional Chinese medicine. “Many Americans incorporate alternative medical practices into their personal health care and are interested in the potential of a variety of traditional Chinese medicine approaches,” Secretary Leavitt said. “This project will advance our understanding of when and how to appropriately integrate traditional Chinese medicine with Western medical approaches to improve the health of the American and Chinese people.” The memorandum of understanding and the establishment of the international collaboration will aid in furthering scientific research on traditional Chinese medicine. Participants in the roundtable include a delegation from the Chinese State Administration on Traditional Chinese Medicine, academics from U.S. universities, and scientists and researchers from NIH, Indian Health Service and the Food and Drug Administration (FDA). Thirty-six percent of Americans use some form of complementary and alternative medicine (CAM), according to the 2002 National Health Interview Survey. In the United States, traditional Chinese medicine is an alternative medical system that is considered a part of complementary and alternative medicine. Integrative medicine combines mainstream medical practices with alternative medical practices. Traditional Chinese medicine involves numerous practices including acupuncture, tai chi, and herbal therapies. In 2007, NIH’s National Center for Complementary and Alternative Medicine (NCCAM) supported nearly $20 million in research on traditional Chinese medicine practices. Secretary Leavitt was joined at the signing by FDA Commissioner Andrew von Eschenbach, M.D., and NCCAM Director Josephine P. Briggs, M.D. The roundtable, which was coordinated by NCCAM, National Cancer Institute’s Office of Cancer Complementary and Alternative Medicine and the Fogarty International Center, is being held in advance of the Fourth Session of the United States-China Strategic Economic Dialogue, which began today in Annapolis, Md.

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Posted in: Acupuncture, Clinical Trials, Herbs & Supplements, Science and Medicine

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Should We Study Chelation for Autism?

The National Institute of Mental Health (NIMH) supports doing a study on the effects of oral chelation therapy in autism. The proposal is highly controversial, is drawing criticism from many scientists, but has popular support among parents who believe this type of therapy might help their children with autism. The proposal raises many questions about the ethics of biomedical research.

Chelation and Autism

Chelation therapy is a legitimate FDA approved treatment for heavy metal poisoning. The drugs used for chelation, such as disodium EDTA, bind to heavy metals so that they can be removed from the body. Chelation drugs can be given either orally or intravenously. The treatment is somewhat risky because it can also remove needed electrolytes, like calcium, from the body or causes shifts in the electrolytes that can cause arhythmias and changes in brain function. There are reported cases of cardiac arrest and death due to chelation.

Chelation therapy has a long history of quackery – not for its intended use but for other uses for which there is no evidence. The classic example of this is the use of chelation therapy to treat atherosclerosis to prevent heart disease. This claim persists despite the utter lack of evidence for efficacy and the fact that all proposed mechanisms have been shown to be flawed or false.

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Posted in: Clinical Trials, Medical Ethics, Neuroscience/Mental Health, Vaccines

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Resistance is futile

Dr. Sampson’s droll post on Thursday written from the point of view of an advocate of unscientific “alternative” medicine modalites (these days known as “complementary and alternative medicine”–abbreviated “CAM”–or “integrative” medicine), coupled with Dr. Atwood’s most recent contribution to his ongoing series on how the mish-mash of a little valid herbal medicine mixed with a whole lot of woo otherwise known as the “profession” of naturopathy is pushing for greater legal legitimacy, depressed me mightily. The posts depressed me because they are but more evidence of just how effective advocates of non-science-based medicine have been over the last several years at twisting the linguistic landscape to their advantage and winning. Indeed, I’ve written about this before on this very blog, including my (in)famous list of medical schools that have embraced CAM and my lament about a medical school that has even gone so far as to “integrate” so-called “integrative” medicine into every aspect of its curriculum from day one of the first year. These disheartening trends accompany and draw succor from the $120 million a year budget of that center of woo in the heart of the National Institutes of Health, the National Center for Complementary and Alternative Medicine, the equal amount of money coming yearly from, alas, the National Cancer Institute, and, of course, the financial clout of the Bravewell Collaborative.

Things are not looking good for science-based medicine in academia right now. I say this in particular because I just learned of a press release issued three weeks ago by Andrew Weil and his University of Arizona Program in Integrative Medicine that, as Emeril Lagasse would say, “Kicks it up a notch,” but not for the better.

The press release begins:
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Posted in: Clinical Trials, Medical Academia, Science and Medicine

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Forks in the road

It’s been decades since the onslaught of organized quackery began against science and reason. Although most physicians are still capable of reasoning, the percentage of medical graduates whose brains have been cleansed of that ability seems to have increased. Either the brains have been cleansed or they have learned to coexist with unreason and to use both functions simultaneously. The latter is quite an accomplishment and is a testament to the flexibility and fluidity of the human mind (shorthand for brain function.) Psychologists have names for that function such as compartmentalization, rationalization, denial, heuristic maintenance, and cognitive dissonance.

Physician advocates of quackery are particularly unsettling because they seem to be so rational at times and appear so to the press and the public. Even more unsettling to me are the medical school department heads and deans and others who loosen the restrictions on the irrational so that peaceful coexistence and polite tolerance seem to be the preferred mode of mental existence in faculties. The NCCAM’s example needs no introduction.

Thus the matter-of-fact tone in which was reported an article in this week’s JAMA. As reported in our local papers, the headlines read: “St. John’s Wort fails to help kids with ADHD [Attention Deficit-Hyperactivity Disorder] in study.” That stopped me for more than one reason. First, any headline about a sectarian or implausible claim is a stopper. But second, StJW for ADHD? I’d never seen the claim. But the article explained that the author felt such a trial was worth doing because someone else had found that StJW increased the level of nor-epinephrine-like compounds in rat brains, so that perhaps St JW would work instead of stimulants for hyperactivity.

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Posted in: Clinical Trials, Medical Academia, Pharmaceuticals, Science and Medicine, Science and the Media

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Stem Cell Therapy and the Need for Transparency

Dr. Geeta Shroff is an Indian physician who is running a New Delhi clinic offering embryonic stem cell therapies for a large number of various medical conditions. The only thing these medical conditions have in common is that they are incurable. Indian law allows for the use of unproven treatments for terminal or incurable diseases. I cannot know Dr. Shroff’s intentions, but she has rejected the ethics and standards of science-based medicine and in so doing has transformed herself into a dangerous charlatan.

Embryonic Stem Cell Therapy

Embryonic Stem Cells (ESC) are controversial because of the ethical and moral consideration regarding harvesting ESC and the rights of an embryo. But that is not what makes Dr. Shroff’s treatments controversial, and not what I am going to write about here. The question, rather, is the state of the science of ESC therapy.

ESC’s are scientifically interesting because they have the potential to turn into any type of cell in the body. The hope for ESC therapy is that they can be used to replace dead or abnormal tissue in the body, something which is not now possible for many conditions. (Organ and bone marrow transplants are among the current treatments to replace failing tissue.) For example, an injured spinal cord might be repaired by using ESC’s to replace the damaged motor neurons and reestablish a connection between the brain and muscles. Atrophied muscles themselves can be repaired by having ESC’s turn into working muscle cells.

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Posted in: Clinical Trials, Medical Ethics, Science and Medicine, Science and the Media

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Early detection of cancer, part 2: Breast cancer and MRI

Note: If you haven’t already, you should read PART 1 of this two-part series. It defines several terms that I will be using in this post, and I don’t plan on explaining them again, given that they were explained in detail in Part 1. Of course, if you’re a medical professional and already know what lead time bias, length bias, and stage migration are, then it goes without saying that you should still read Part 1 for its scintillating prose.

ResearchBlogging.orgWhen last I left this topic three weeks ago, I had discussed why detecting cancer at ever-earlier stages and ever-smaller sizes is not necessarily an unalloyed good. At that time, I discussed in detail a landmark commentary in the New England Journal of Medicine entitled, Advances in Diagnostic Imaging and Overestimations of Disease Prevalence and the Benefits of Therapy. The article, although nearly 15 years old, rings just as true today in its cautioning doctors about whether ever-increasing diagnostic sensitivity that imaging technology and new blood tests were (and are) providing was actually helping patients as much as we thought it was. Before we dive into this problem as applied to breast cancer, let’s review what Drs. Black and Welch had to say about screening tests for breast cancer 15 years ago, as way of background and linking my last post and this one:

Before the widespread use of mammography, most breast cancers were discovered on physical examination, as palpable lumps. In one of the few studies to assess directly the accuracy of physical examination in screening for breast cancer, only 27 percent of tumors more than 1.0 cm in diameter and 10 percent of those less than 1.0 cm in diameter were detected by physical examination. However, the mean size of breast cancers detected by state-of-the-art screening mammography is about 1.0 cm, and many of the cancers detected as microcalcifications are only a few millimeters in size.

Again, prevalence depends on the degree of scrutiny. According to the Connecticut Tumor Registry, clinically apparent breast cancer afflicts about 1 percent of all women between the ages of 40 and 50 years. In a recent medicolegal autopsy study, however, small foci of breast cancer were found in 39 percent of women in this age group. Most cancers were in the form of ductal carcinoma in situ. Furthermore, over 45 percent of the women with cancer had two or more lesions, and over 40 percent had bilateral lesions. Although it has been argued that such small in situ lesions are not detected by and are therefore irrelevant to screening mammography, about half the lesions in that study were detected, usually as microcalcifications, on postmortem plain-film radiography of the resected breasts. Because of continual technical improvements and increasingly broad criteria for the interpretation of mammograms, the detection threshold for breast cancer has fallen considerably since the time of the Breast Cancer Screening Project of the Health Insurance Plan of Greater New York (1963 to 1975). This can explain the increased prevalence of cancer on mammographic screening, from 2.717 to 7.614 per 1000 examinations (with the incidence increasing from 1.517 to 3.214 per 1000 examinations). The lower detection threshold can also explain the increase in the percentage of carcinomas in situ (stage 0) among all mammographically detected cancers — from 12.7 percent to over 30 percent. The principal indication for biopsy has changed from suspicious mass to suspicious microcalcifications. This can explain why the reported incidence of breast cancer has increased and why most of the increase is in smaller lesions, particularly ductal carcinoma in situ.

About a year ago, three major articles hit the medical press that made me start thinking about this more than I had in the past. It’s my job, after all, because breast cancer surgery is a large part of my practice, and I do breast cancer lab-based research. What also tweaked me not to put off doing part 2 of this series is that, just two days ago, there was an abstract presented at the American Society of Clinical Oncology Meeting (where I still am today) that also serves to highlight just how difficult this question of integrating a test as sensitive as MRI into a screening regimen for and preoperative evaluation of breast cancer is and how MRI should fit into in this regimen can be.
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