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Archive for January, 2011

Breast implants and anaplastic large cell lymphoma (ALCL): Is there a link?

I must admit that I have a bit of a love-hate relationship with breast implants. On the one hand, as a breast cancer surgeon, I see them as a major benefit to my patients who are unfortunate enough to require mastectomy in order to control their disease. The armamentarium of techniques for reconstructing breasts after mastectomy generally falls into one of two categories, either various form of muscle flaps or breast implants. However, some women are, for various reasons, not eligible for various muscle flap reconstructions. That leaves either breast implants–or nothing. Certainly, some women are perfectly fine with no reconstruction after mastectomy, but many, if not most, women are not. For these women, it would be difficult to overstate how much of a boon to body image and self-esteem reconstruction can be, particularly given how much better at it plastic surgeons have become over the last couple of decades.

On the other hand, breast implants make my life as a breast cancer surgeon more difficult for a variety of reasons. First, they tend to make mammography more difficult by obscuring part of the breast, thus decreasing the sensitivity of mammography. Good mammography facilities can get around this to some extent by using various displacement techniques, but it takes some effort, and it doesn’t completely correct the problems that implants cause for mammographic screening. Moreover, when a woman who has had implants placed for cosmetic reasons comes to see me for a breast mass or an abnormal mammogram, the presence of the implants can complicate treatment decisions. If the abnormality or mass is close to the implant, we worry about rupturing it in the process, particularly if the implant is not below the pectoralis major muscle. Even when the implant is subpectoral, the muscle overlying it frequently ends up being so stretched out that the muscle in essence forms part of the capsule around the implant and ends up being a lot thinner than you might expect. Let me tell you, my anal sphincter tone is always much tighter when operating near an implant, particularly a silicone implant. True, I’m perfectly capable of removing an implant if it’s accidentally ruptured, but such an outcome is not desirable, particularly with silicone implants, where cleaning up the leaking silicone can be difficult.

It doesn’t help that silicone breast implants have been the subject of controversy since the late 1980s and early 1990s, when thousands of women with silicone implants reported a variety of ailments, including autoimmune disease and a variety of other systemic illnesses. These reports led to a rash of lawsuits and, ultimately, the banning of silicone breast implants for general use in 1992. After that, silicone breast implants were only permitted in women requiring breast reconstruction or women enrolled in clinical trials studying breast implants. This ban was partially lifted in 2006, as evidence accumulated that the claims of autoimmune diseases and increased cancer risk due to silicone breast implants were not supported by clinical and scientific evidence and two products made by Allergan Corp. (formerly Inamed Corp.) and Mentor Corp. Not surprisingly, given that the furor over silicone breast implants as a cause of autoimmune and other systemic diseases is based on about as much solid scientific evidence as the antivaccine furor over vaccines as a cause of the “autism epidemic,” there was widespread criticism of this decision. Even now, it is not difficult to find articles about breast implants with titles like Breast Implants: America’s Silent Epidemic and websites like the Humantics Foundation and Toxic Breast Implants . I do note, however, that the number of such sites and articles does appear to be declining and, at least to my impression, seems to have decreased markedly over the last 10 years or so.

Having reviewed the literature and found evidence for a link between silicone breast implants and the systemic diseases attributed to them to be incredibly weak at best, I had little problem with the FDA’s decision. Actually, the only thing I had a problem with at the time, my opinions of how breast implants interfere with breast cancer detection and treatment notwithstanding, is that the FDA was probably being more cautious than the evidence warranted after 14 years.

Was I wrong?
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Posted in: Cancer, Epidemiology, Politics and Regulation, Public Health

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Rambling Musings on Using the Medical Literature

For those who are new to the blog, I am nobody from nowhere. I am a clinician, taking care of patients with infectious diseases at several hospitals in the Portland area. I am not part of an academic center (although we are affiliated with OHSU and have a medicine residency program). I have not done any research since I was a fellow, 20 years ago. I was an excellent example of the Peter Principal; there was no bench experiment that I could not screw up.

My principal weapon in patient care is the medical literature, accessed throughout the day thanks to Google and PubMed. The medical literature is enormous. There are more than 21,000,000 articles referenced on Pubmed, over a million if the search term ‘infection’ is used, with 45,000 last year.

I probably read as much of the ID literature as any specialist. Preparing for my Puscast podcast, I skim several hundred titles every two weeks, usually select around 80 references of interest and read most of them with varying degrees of depth. Yet I am still sipping at a fire hose of information

The old definition of a specialist is someone who knows more and more about less and less until they everything about nothing. I often feel I know less and less about more and more until someday I will know nothing about everything. Yet I am considered knowledgeable by the American Board of Internal Medicine (ABIM), who wasted huge amounts of my time, a serious chunk of my cash, and who have declared, after years of testing, that I am recertified in my specialty. I am still Board Certified, but the nearly pointless exercise has left me certified bored. But I can rant for hours on Bored Certification and how out of touch with the practice of medicine the ABIM is.

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Posted in: Clinical Trials, Science and Medicine

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The English government cracks down on alternative pet remedies

One cannot play charades forever.

European veterinary groups have long been more skeptical about “alternative” veterinary practices than their American counterparts. For example, the European Board of Veterinary Specialties refuses to grant continuing education credits for non-scientific endeavors attempting to masquerade as a way to improve one’s clinical knowledge, and the practice of veterinary homeopathy is forbidden in Sweden.

Now comes good news (for pets, and pet owners), out of the UK. In an effort to improve animal health and welfare, the Veterinary Medicines Directorate’s (VMD) has targeted “alternative” remedies, which, of course, pose both real and potential dangers to pets. The VMD is the body responsible for the authorization of veterinary medicinal products in the United Kingdom.

Specifically, the VMD is targeting a number of unauthorized products that lack scientific proof of effectiveness, including:
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Posted in: Politics and Regulation, Veterinary medicine

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Statins – The Cochrane Review

A recent Cochrane review of the use of cholesterol-lowering statin drugs in primary prevention has sparked some controversy.  The controversy is not so much over what the data says, but in what conclusions to draw from the data.

Statin drugs have been surrounded by controversy for a number of reasons. On the one hand they demonstrably lower cholesterol, and the evidence has shown that they also reduce the incidence of heart attacks and strokes. The data on whether or not they reduce mortality has been less clear, although this latest data actually supports that claim. However, statins have also been blockbuster drugs for pharmaceutical companies and this has spawned concerns (some might say paranoia) that drug companies are pushing billions of dollars worth of marginally effective drugs onto the public.

So are statins a savior or a scam? Life does not always provide nice clean answers to such simple dichotomies. The evidence clearly shows that statins work and are safe. However, pharmaceutical companies do like to present their data in the best light possible, and they need to be watched closely for this. The recent review does call them on some practices that might tend to exaggerate the utility of statins. Finally, the real question comes down to – where should we draw the line in terms of cost-benefit of a preventive measure like statins.

Let’s look as this recent review of the data to see what it actually shows.

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Posted in: Epidemiology

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One Hump or Two? Camel’s Milk as a New Alternative Medicine

I wasn’t really surprised to learn that camel milk is being promoted as a medicine. I long ago realized that the human power of belief is inexhaustible. The news did make me laugh, probably because camels are rather funny-looking animals, because I am easily amused, because it reminded me of some of my favorite camel jokes, and because it wouldn’t do any good to cry.

Camel milk has been claimed to cure or benefit patients with diabetes, tuberculosis, stomach ulcers, gastroenteritis, cancer, allergies, infections, parasites, autism, even AIDS.  This isn’t really quite as silly as it might sound.  PubMed does list several studies showing health benefits from camel milk. A handful of studies have suggested that camel milk improves control of blood sugar in diabetes, but they are preliminary studies that typically compare standard treatment to standard treatment plus camel milk rather than using a blinded control. There are also a few small, poor quality studies suggesting a possible benefit in allergies, in peptic ulcers, in infections such as hepatitis, and in schistosomiasis. All in all, the research doesn’t amount to much. Camel milk can only be classed as experimental treatment. The existing studies justify doing more (and better quality) research, but they don’t justify prescribing it to treat patients.
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Posted in: Nutrition

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Molecular breast imaging (MBI): A promising technology oversold in a TED Talk?

Occasionally, there are topics that our readers want — nay, demand — that I cover. This next topic, it turns out, is one of them. It’s a link to a TED Talk. I’m guessing that most of our readers have either viewed (or at least heard of) TED talks. Typically, they are 20-minute talks, with few or no slides, by various experts and thought leaders. Many of them are quite good, although as the TED phenomenon has grown I’ve noticed that, not unexpectedly, the quality of TED Talks has become much more uneven than it once was. Be that as it may, beginning shortly after it was posted, readers of both this blog and my other super-not-so-secret other blog started peppering me with links to a recent TED Talk by Dr. Deborah Rhodes at the Mayo Clinic entitled A tool that finds 3x more breast tumors, and why it’s not available to you.

At first, I resisted.

After all, I’ve written about the issues of screening mammography, the USPSTF guideline changes (here, too), the early detection of cancer (including lead time and length time bias, as well as the Will Rogers effect), and a variety of other topics related to the early detection of breast cancer, such as overdiagnosis and overtreatment. Moreover, to put it bluntly, there really isn’t anything radically new in Dr. Rhodes’ talk, at least not to anyone who’s been in the field of breast cancer for a while. Certainly, there’s no new conceptual breakthrough in breast imaging and screening described. As I will discuss in more depth later in this post, there’s an interesting application of newer, smaller, and more sensitive detectors with a much better spatial resolution. It’s cool technology applied to an old problem in breast cancer, but something radical, new, or ground-breaking? Not so much. What Dr. Rhodes describes in her talk is the sort of device that, when I read about it in a medical journal, produces a reaction along the lines of, “Nice technology. Not ready for prime time. I hope it works out for them, though. Could be good.” So it was with molecular breast imaging (MBI), which is the topic of Dr. Rhodes’ talk. So I continued to resist for about two or three weeks.

Then our very own Harriet Hall sent me the link. I cannot resist Harriet. When she suggests that perhaps I should blog about a topic, it’s rare that my response would be anything other than, “Yes, ma’am. How soon would you like that post and how many words?” I keed, of course, but only just. The best I could come up with was a wishy-washy “But this isn’t really anything all that new,” which is true enough, but the way Dr. Rhodes tried to sell the audience on the idea of her technology brings up a lot of issues important to our audience. I also thought it was important to put this technology in perspective. So here I go. First, I’ll start by describing what really set my teeth on edge about Dr. Rhodes’ talk. Then I’ll go to the primary literature (namely her brand, spankin’ new article in Radiology describing the technology) and discuss the technique itself.
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Posted in: Cancer, Clinical Trials, Diagnostic tests & procedures, Medical devices, Science and the Media

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Old drugs, new tricks

What does honey bee colony collapse disorder have to do with a potential new cancer treatment?

They both relate – in a convoluted manner – to an old antibacterial drug called nitroxoline.

True to my devotion as a natural product pharmacologist, I’m proud to say that new life would not have come to nitroxoline had not a fungal natural product called fumagillin been studied as an antiangiogenic anticancer drug – one that inhibits the formation of new blood vessels.

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Posted in: Basic Science, Cancer, History, Pharmaceuticals

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The risks of CAM: How much do we know?

Working in pharmacies where supplements are sold alongside traditional (over-the-counter) medications, I’m regularly astonished at the different perceptions consumers can have about the relative efficacy and safety of different types of products. Once, speaking with a customer about a medical condition she wanted to treat, I indicated that there were no effective non-prescription therapies — she needed to see a physician for access to an effective treatment by prescription — and I gestured behind the counter. “Back there?!” she pointed. “That’s where you keep the stuff that kills people! I want something natural!” Suggesting that my patients with heart disease or HIV had a somewhat different perspective, I tried (unsuccessfully) to talk her out of a questionable-looking supplement (Hint: avoid anything from a company with a P.O. box as a mailing address.) This appeal to nature, combined with a perception that natural products are safe, and conventional drugs are unsafe, is pervasive. (more…)

Posted in: Herbs & Supplements, Pharmaceuticals

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For shame, Dr. Oz, for promoting Joseph Mercola on your show!

I’ve been highly critical of Dr. Mehmet Oz, Vice Chair of the Department of Surgery at Columbia University and medical director of the Integrative Medicine Program (i.e., Columbia’s quackademic medicine) program at New York-Presbyterian Hospital. Those are his academic titles. More important, in terms of his promotion of pseudoscience, is his role as daytime medical show host. Dr. Oz’s television show, called, appropriately enough, The Dr. Oz Show, is a direct result of his having been featured on Oprah Winfrey’s show on numerous occasions as one of her regular medical experts. Because of his popularity, Dr. Oz became Oprah’s protégé and ultimately scored his very own daytime TV show, which has been quite successful since its debut in September 2009.

So what has led me to conclude that I’ve finally completely had it with Dr. Oz? Or, as Popeye would say, “I’ve had all I can stands, I can’t stands no more!”

The final straw occurred yesterday, but this has been building up for a while. Of course, I’ve known for a long time that Dr. Oz has a weak spot for “alternative medicine.” A decade ago, he was known for bringing reiki masters into the operating room do their mystical magical gestures during cardiac surgery, the better to channel the healing energy of the “universal source” into his patients before they went onto the cardiopulmonary bypass machine. His wife is also a reiki master, which might explain his particular fondness for this form of faith healing. Even so, even though I always knew Dr. Oz was into some woo, most of the times I ever saw him on Oprah’s show and the rare occasion that I’ve seen his show, the worst I could say about him was that he is at best a shruggie and at worst too prone to mixing perfectly valid, science-based information with the “softer” forms of “complementary and alternative” medicine (CAM) modalities, such as acupuncture and reiki. Even so, CAM didn’t seem to be a major part of his show. That seems to have changed in 2010.

As 2010 dawned, I became aware of a show in which Dr. Oz promoted reiki completely uncritically, beginning the year with a show entitled Dr. Oz’s Ultimate Alternative Medicine Secrets. It wasn’t too long before Dr. Oz did it again, delivering a two-fer of “quantum” quackery coupled with just plain quackery, when he invited Deepak Chopra and Joe Mercola on his show. Around the same time, Dr. Oz also revealed in an interview also hadn’t had his children vaccinated against H1N1. In all fairness, he seemed embarrassed to admit this and uncomfortable about the situation (Dr. Oz has never, to my knowledge, expressed anti-vaccine views), but, even so, he did seem to be more sympathetic than the evidence warrants to the concept that vaccines might somehow cause autism. None of these occurrences was good, but, as disturbing as they were, none of them quite crossed a line. Quite.

As 2011 dawns, there is no doubt in my mind that Dr. Oz has now irrevocably crossed his Woo-bicon (link there to make my pun painfully obvious), gone over to the Dark Side, betrayed the cause, gone woo, or whatever you want to call it. He’s done, as far as science-based medicine goes. That’s because yesterday he featured one of the biggest promoters of highly dubious medical remedies on the Internet on his show in one fawning segment after another. I’m referring, of course, to Dr. Joe Mercola, who was the main guest on The Dr. Oz Show yesterday in segments entitled The Alternative Health Controversy (part 1, part 2, part 3), coupled with another segment entitled The Surprising Supplement You Need. Let’s just say that Dr. Oz’s journey to the Dark Side is now complete. He has controlled his fear but released his woo, and it is strong woo indeed.
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Posted in: Herbs & Supplements, Science and the Media

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