White Coat Underground

An unfortunate happening

Fri, 12 Mar 2010 08:40:01 -0500

Our beloved, beat-up laptop is ill--very ill. The family is considering consenting to a Do Not Resuscitate order. Symptoms of this grave illness include inability to exit the start up screen and freezing up in "safe mode". The agonal Blue Screen of Death has not yet appeared, but is believed to be immanent.

Victory for science, humiliation for antivax nut

Wed, 10 Mar 2010 17:37:06 -0500

A few months ago, attorney Ames Grawert and I wrote about a defamation case filed by noted anti-vaccine crank Barbara Loe Fisher against respected journalist Amy Wallace, vaccine expert Dr. Paul Offit, and Conde Nast. The suit arose from a statement by Offit in an excellent article by Wallace. At one point in the lengthy article, Offit is quoted as saying, regarding Loe Fisher, "She lies."

Loe Fisher launched the defamation suit based on these two words, claiming they made her appear "odious, infamous, and ridiculous." Anyone who has read Loe Fisher's writing at her National Vaccine Information Center knows that she needs no help in this regard.

But the judge who drew the case didn't comment on Loe Fisher's idiocy, just her error in thinking that the law protects her from heated criticism. The case was dismissed today. In his ruling, US District Judge Claude Hilton stated that since it is nearly impossible to prove or disprove the statement "she lies", something statute requires, and that since hyperbole uttered in heated debates is clearly protected free speech, the case cannot proceed.

Thank the US Constitution and our long history of protection of free speech for our ability to duke it out verbally without fear of an avalanche of frivolous lawsuits. Scientific fact is not a matter of law, and science cannot proceed in an atmosphere of fear of open debate.

Shame on you Barbara (of course, there will always be an England).

(h/t CS)

What else does Dr. Kaiser have to offer?

Wed, 10 Mar 2010 13:50:25 -0500

The other day I told you about a doctor promoting a dietary supplement for the treatment of HIV, despite the lack of any significant data to support his claims. If there's anything medical bloggers have found over the years is that woo rarely walks alone.

In my post I expressed some incredulity at the fact that Kaiser promotes himself as an internist and HIV expert despite any of the usual formal education required for these designations. Examination of his website reveals that he is also an expert in "longevity", cancer, chronic fatigue, autoimmune disease, and intestinal parasites. Fascinating.

According to Kaiser's website:

Integrative Health Consulting believes that a comprehensive healing program of aggressive natural therapies, combined with standard medical treatment and mind-body healing techniques, is vital to the successful treatment of most serious medical conditions.

Every day I hear from patients and friends with serious diseases who are trying to sort through the piles (pun intended) of unsolicited advice about their serious diseases. When I see bullshit like this, all I can think of is my friends who might read this and be taken in. The statement that "Integrative Health Counseling believes that..." is wonderfully useless. What the company does or does not believe about its offerings is not a good gauge of their utility. What are "aggressive natural therapies" and what data supports their use? As with most questionable medical practices, their program just happens to be good for everything. That's terribly convenient.

Comprehensive Healing Programs consist of recommendations from each of the following seven categories:
1) Diet
2) Vitamins & Nutritional Supplements
3) Herbs & Acupuncture
4) Individualized Exercises Programs
5) Stress Reduction/Positive Attitude
6) Hormone Balancing
7) Medical Therapy

The use of a combination of recommendations from the above categories imparts a far better success rate than the use of one category alone (i.e. medical therapy). When an approach such as this is taken to the treatment of chronic conditions such as cancer, hepatitis, autoimmune disorders, and chronic fatigue syndrome a high success rate is achieved.

Really? How do you know that? So, you're claiming that by combining medical therapy with a bunch of unproven and disproved modalities, you fix people with serious diseases.

These kind of claims are unethical and cruel. And what's up with "intestinal parasites"? Seriously? Kaiser makes the claim that, "in the United States, intestinal infections are the third-leading cause of illness and disease." What the hell does that mean? What is "illness" and what is "disease"? The leading causes of death in the U.S. are heart disease, cancer, and stroke. Actually, I'm not even sure what "cause of disease" means? Cause of what kind of disease? Common serious diseases in the US include diabetes, hypertension, heart disease. One of the most common, although not serious, diseases is the common cold.

He goes on to argue that intestinal parasites are a major cause of illness in the U.S. and that he has special knowledge about the diagnosis and treatment of parasitic diseases.

While local hospital laboratories usually do a decent job at identifying intestinal parasites, specialty laboratories are able to significantly increase the yield of the test because of their additional expertise.

One of the most common techniques of pseudo-experts is their use of special laboratories to "increase the yield" of the desired results. Whether it's heavy metal tests or testosterone assays, unconventional doctors have a long history of hunting around for labs, basing the quality of the lab on it's ability to produce a positive result rather than the the external validation of its procedures. He says of the lab he prefers:

The test that I routinely order is called a "Comprehensive Parasitology - Random" and it not only looks for intestinal parasites but tests for fungal and bacterial imbalances in your gut as well. This is not the lab's most expensive test, but it does a very good job at evaluating the health of a person's intestinal system at a reasonable cost (prepay price: $132). Unfortunately, it must be ordered by a physician or other health care practitioner (chiropractor, acupuncturist, etc.).

As we saw in yesterday's post, not only is Kaiser not an infectious disease specialist, he's not board certified in any medical specialty, which puts him in good company with "chiropractor(s), acupuncturist(s), etc."

But the obsession with parasites makes some sense in light of the material presented on his page about "longevity":

The foundation of one's health is based upon a strong gastrointestinal (GI) system.
[...]

The health of your GI system can be improved through a variety of means. These include dietary interventions, vitamin supplementation, pre and pro biotic supplements (such as acidophilus and yogurt), stress reduction, castor oil packs, deep abdominal massage, etc. Improving the health of your GI system can have substantial effects on your overall health and it is often the first system I investigate when putting together an optimal longevity management program.

Does any of that sound familiar to you? The colon is one of the favorite bugaboos of alternative medicine folks, and most of their ideas are bunk.

And what is "longevity management"? When it comes to preventing premature death, there is some data out there: obesity seems to put one at risk for premature death, as does failure to properly prevent and treat diabetes and heart disease. But there is almost certainly an upper limit on how long one can live, even with the best health. But colon health? Really?

I left the door open to see what results will eventually shake out with Kaiser's approach to micronutrient supplementation in HIV disease. It's not implausible, there just isn't any convincing evidence at this point. Kaiser's website doesn't exactly give me confidence in his knowledge of science as the basis of the practice of medicine does not exactly shine through on his website.

Dr. Kaiser responds

Wed, 10 Mar 2010 08:42:50 -0500

I was pleased to see that Dr. Kaiser responded to post from earlier this week. If you'll recall, Dr. Jon Kaiser is a doctor in California who is promoting a nutritional supplement to help treat HIV disease. I was hoping his response would be substantive, containing references to data I had missed in my research of the story. In this I was disappointed.

Dr. Lipson,
I was surprised when I read your recent blog about my career, expertise and perspective on HIV treatment.

Facts and science can be manipulated to support any opinion, so it is a fruitless exercise to engage in a point by point correction of your numerous mischaracterizations. But I will speak to a few of the core issues you raised.

Translation: "I have no actual data to refute your points, but I am about to drag you through a tangled heap of rhetorical mis-steps and logical fallacies."

I arrived in San Francisco during the height of the AIDS epidemic. Since that time, I have treated over two thousand HIV-positive patients and have dedicated my life to helping individuals with this condition live normal life spans. Back in the days before any effective drugs were available to treat this condition, and HIV infection was regarded as 100% fatal, I decided reject that belief. I then began exploring ways to help my patients outlive that prediction. Many of these patients are still healthy and alive today.

As I stated in my original piece, a number of older HIV docs were internists or other type of specialists, such as hematologist/oncologists, rather than infectious disease specialists and had to invent the field of HIV medicine as the epidemic developed. Not that Kaiser is an internists, having completed only one year of post-graduate training, but arriving in SF during the height of the epidemic would give any doctor an interesting, frightening, and humbling experience. Except Kaiser wasn't humbled in the face of disease; he "decided to reject" the fact that before anti-retroviral therapy became available, HIV was almost uniformly fatal. There have always been a few long-term non-progressers, some of whom may have certain genetic protection against HIV, such as a CCR5 mutation. But I view with some skepticism his claim that he yanked patients away from certain death with his revolutionary ways.

I would be surprised if the seven pharmaceutical companies who have enjoyed my participation as a consultant or speaker, the American Academy of HIV Medicine on whose Reimbursement Committee I have served, the International Journal of Infectious Diseases on whose editorial board I have participated, or the World AIDS Conference which invited me to present my research study results, share your perspective on my expertise and legitimacy as an HIV researcher and treatment specialist.

None of those facts actually make one an "HIV expert". I'm not saying he isn't an expert, but serving on the "reimbursement committee" of a lower-tier HIV organization hardly makes one an expert. As for his presentations, well, one traditional definition of "expert" is someone from out of town with slides. He seems to fit this definition, but having only one peer-reviewed publication in his field, one that required an editorial note to explain his conflict of interest, argues against him being an expert by other standards.

Despite your belief that a micronutrient supplement can't possibly act as a potent immune modulator, several pharmaceutical companies have already expressed interest in investigating K-PAX's Immune Support Formula in combination with their drugs.

Perhaps he hasn't read my piece all that carefully, or he just has a thing for straw men. I have no way of knowing what is in his heart, but I never argued against the plausibility of micronutrients assisting in the treatment of HIV---just that the data and claims he presented were not good evidence to support it. Perhaps some day evidence will support the use of his supplement, but that day has not yet come.

Over the course of my career, one of the more important lessons I've learned is that it's not about one side being right and the other side being wrong. Such finger-pointing divides the research and treatment communities, and ultimately, it's the patients who lose out in the end. We see this trend playing out today in the debate on healthcare reform; the right and left devote extraordinary time to discrediting the opposition, a dialogue which ultimately impedes moving forward on important issues.

Actually, in science it often is about being wrong. There is not always a "middle ground" in science. To claim that patients "lose out" by scientists vigorously debating facts is absurd. This is exactly how science works, and to search for a compromise rather than the truth is a mistake. The dialog is the science. Moving forward without examining facts is not called science, it's called religion.

From my perspective, it's not whether you believe that drugs or natural approaches are the best treatment option; it's that utilizing both approaches together yields the best possible outcome. This treatment philosophy has been proven in diabetes (weight loss, exercise, and insulin), heart disease (weight loss, exercise, and medications), osteoporosis (calcium supplements, vitamin D supplements, and exercise), and hypertension (diet, exercise, stress management, and drugs).

Without evidence that "utilizing both approaches...yields the best possible outcome" it is simply a bold assertion. It is a plausible assertion, but the history of medicine is littered with plausible assertions that never panned out.

Comprehensive care paradigms, which blend conventional drug treatments with natural approaches, will no doubt continue to prove useful in many additional diseases. And as the debate continues around these emotionally charged issues, patients deserve to hear the whole story, with as little vitriol and personal opinion as possible, so they can make informed decisions about their health.

"No doubt"? Science is doubt. And I agree that "patients deserve to hear the whole story." Do you tell your patients that you own the company whose products you sell? Do you tell them that there is no good evidence yet available to support their use?

I was hoping Dr. Kaiser would turn out to be a well-intentioned but misguided healer. I may have been wrong. I think it may be time to go over to his website and examine the rest of his claims a bit more closely. Stay tuned.

A nutritional approach to the treatment of HIV infection---same old woo?

Mon, 08 Mar 2010 05:59:11 -0500

I get all sorts of mail. I get mail from whining Scientologists, suffering patients, angry quacks---and I get lots of promotional material. I get letters from publishers wanting me to review books, letters from pseudo-bloggers wanting me to plug their advertiblog---really, just about anything you can imagine.

Most of the time I just hit "delete"; it's obvious that they've never read my blog and they're just casting a wide net for some link love. But a recent email from a PR firm piqued my interest: (it's a long letter, and I won't be offended if you simply reference it rather than read the whole thing now):

Hi Dr. Lipson,

My name is N. and I am reaching out to you on behalf of Dr. Jon Kaiser, an esteemed HIV/AIDS and nutrition specialist who specializes in supporting immune system function with nutrition. I recently read your blog post titled "Will Congress Finally Reform Supplement Laws" and thought you might be interested in Dr. Jon Kaiser's perspective on the role of nutritional supplementation in medicine.

Dr. Kaiser is well-known in the global AIDS/HIV community. In the 1980's, Kaiser pioneered the use of nutritional supplements in HIV/AIDS patients to help them build stronger immune systems; his research showed that conventional drug treatments were more effective if the patient's immune system were strong. Today, many AIDS and HIV patients around the world follow this treatment paradigm. As a physician, Dr. Kaiser is well-known in the global AIDS/HIV community.

In the 1980's, Kaiser pioneered the use of nutritional supplements in HIV/AIDS patients to help them build stronger immune systems; his research showed that conventional drug treatments were more effective if the patient's immune system were strong. Today, many AIDS and HIV patients around the world follow this treatment paradigm. Building upon his success in HIV patients, Dr. Kaiser is applying the lessons learnt in HIV to patients with cancer, Chronic Fatigue Syndrome and other chronic diseases, general health and the elderly.

Dr. Kaiser is very passionate about advocating nutritional supplementation and views it integral to successful disease and general health management. He would more than like to share and engage in a discussion about the supplements and the impact of the proposed reforms to supplement laws. I've included more information on Dr. Kaiser and K-PAX and I have pasted links to a 2001 double-blind, placebo-controlled study funded by Bristol-Myers Squibb that demonstrated an increase in the number of CD4 lymphocytes in HIV-infected patients who were taking Dr. Kaiser's natural immune support formula compared to patients taking a placebo (in addition to standard HIV medications). This formula has been refined over 15 years and is now in clinical trials with the goal of receiving FDA approval. If successful, Dr. Kaiser will be one of the first nutritional suppliers to gain FDA approval for the use of a nutritional supplement as an adjunctive therapy for disease management.

I've never heard of Kaiser, and the only K-PAX is know is home to Prot. So I looked it all up.

Before I assume anything about a doctor, I always check to make sure they're really a doctor. Jon Kaiser is an M.D. in northern California. He graduated from a real medical school where he apparently performed well. According to the state medical board, his license is current and he has no official actions against him. He has reported to the state board that he is not board certified in any specialty, but claims non-boarded specialty status in internal medicine and infectious disease. He reported to the board and listed on his CV that he has one year of post-graduate training. I'm not sure how one can claim to be an internist without specialty training, but he does.

To specialize in internal medicine requires three years post-graduate training, and to specialize in infectious diseases generally requires an additional 1-3 years of post-graduate training. It's not unheard of for older HIV specialists to not have formal infectious disease training---many of them were internists who invented the field of HIV medicine out of necessity when the epidemic first appeared. But to practice internal medicine or infectious disease with only one year of post-graduate training (an internship probably) is very, very unusual. My state currently requires completion of two years of post-graduate training in a certified program, although since two year programs are vanishingly rare, most licensed physicians will have at least three years. In the old days, a doctor could finish an internship and hang up a shingle as a family doc. But even back in the 80s, internal medicine had become far too complex to rely on just an internship. Hell, my dad graduated from medical school in 1949 and even then internists were expected to compete a full residency program.

This doesn't mean Kaiser isn't a good doctor, but it raises the bar on any claims he makes. If I know that someone is a boarded internist and infectious disease specialist, and is published in her fields of specialty, I'm likely to require a bit less as far as proving his or her credibility. Someone who completed a brief course of post-graduate training and declares themselves to be an expert will require a lot more to convince me of their expert status.

Most HIV specialists are infectious disease specialists first, and if they belong to a professional organization it is usually the IDSA or the HIVMA. His CV lists him as a member of the American Academy of HIV Medicine. I'm not familiar with their work, but their website has some useful information. Included is a verification engine to see if a doctor is a member: Kaiser is not listed on their verification site. He lists himself as being on multiple boards, so I'm assuming this is a glitch in the system. He also lists himself as a founding member of the California Academy of HIV Medicine, an organization I cannot yet find on the web. I asked his publicist about this and this was Dr. Kaiser's response:

As a founding member of the American Academy of HIV Medicine, I was intimately involved in setting policy objectives for the organization in its early development phase beginning in 2000. I formed the Academy's Reimbursement Committee in 2000, and was quoted in the attached AAHIVM newsletter (see middle column, paragraph #2). I have also been certified as an HIV Specialist by the organization on two separate occasions (see attached). It appears my membership to the national organization and California chapter inadvertently lapsed when I moved offices. This has been corrected and my membership is now currently active.

Well, I guess that explains the discrepancy between his CV and the professional organization he claims membership and leadership experience in. Unfortunately they didn't find me a link to the CAAHIVM. Perhaps they don't have a website.

Anyway, I was curious about the publicist's claim that Kaiser is a major player in the HIV community, so I did a PubMed search. It turned up three references. I guess one can be a respected HIV clinician rather than a researcher, and that would certainly not show up in PubMed. But that leads to another problem.

Kaiser bills himself as "combining the best of natural and standard therapies" for HIV disease. I have no reason to doubt this, but since his approach is unorthodox and he isn't an active researcher I'm not sure how he knows that his treatment is so good. He does claim some pretty spectacular results:

Though long term stability in my patients has always been the rule, I can now definitely say that the progression of HIV disease in my practice is an extremely rare event. This experience, which has encompassed the care of over 500 HIV(+) patients during the past five years, allows me to make the following statements: Not one patient who has come to me during the past six years with a CD4 count of greater than 300 cells/mm3 has progressed to below that level. Not one patient who has come to me during the past six years with a CD4 count of greater than 50 cells/mm3 has become seriously ill or died from an HIV-related illness.

This extraordinary level of good health and stability does not come without hard work. My patients follow an aggressive program of natural therapies to support their immune systems. They have also benefited tremendously from the new drugs, lab tests, and other recently released treatment options. What a difference a few years has made!

That seems pretty impressive to me, for a few reasons. In many circumstances, someone who has gathered this much favorable data would have published it. Without seeing the data in a peer-reviewed journal, there's no way to verify the validity of these claims, or the reason for them. If the data are accurate, perhaps he attracts a very medically-adherent population. At many of the HIV centers I'm familiar with, patients often have financial, social, and psychiatric barriers to care, and results aren't so rosy. So what's this guy's secret? Does he have a really, really compliant set of patients, or is he doing something different, something not yet well-represented in the HIV literature?

According to him, the secret is his "comprehensive" approach:

I define a comprehensive approach as one which adds a program of aggressive natural therapies and emotional healing techniques to the standard medical treatment of an illness or condition. An aggressive natural therapies program includes a combination of diet therapy, vitamins, herbs, exercise, and stress reduction. Emotional healing encompasses a proactive program of psychological healing techniques that ideally includes a spiritually-oriented practice (prayer, meditation, yoga, etc.) combined with a significant level of social support.

That's a bold statement. He claims extraordinary results, and claims that a raft of disproved therapies are the answer. If, as he claims, this approach is especially beneficial to those who cannot tolerate proven therapy with anti-retroviral drugs, he really should be working off data, data that show that his approach is safe and effective.

And that brings us back to the original letter from his publicist. In the letter, they claim that K-PAX (the supplement, not the planet) significantly increased CD4 counts compared to placebo in patients taking usual therapy.

Whether CD4 cell count is a useful measure in this setting is debatable. Viral load is an important measure of HIV activity, and CD4 count varies from moment to moment. Also, above a certain level, it's not clear that CD4 cell count is a marker of clinical risk. Important outcomes other than CD4 cell count and viral load include prevention of opportunistic infection.

In Kaiser's study, published as a "rapid communication", he measured many parameters in addition to CD4 count. This was a very small study (40 patients) with a very brief follow up period (12 weeks). In the results section, the author notes that there were differences in the characteristics between the test and control groups, and that these differences were not statistically significant:

(1) the micronutrient group had a lower CD4 count at baseline when compared with the placebo group (CD4: 357 ± 154 cells/μL vs. 467 ± 262 cells/μL, P = 0.13), (2) the participants in the micronutrient treatment group reported a greater number of months of neuropathy symptoms preceding enrollment than those in the control group (means: 21.4 months vs. 12.2 months, P = 0.14; medians: 14.2 months vs. 2.5 months), and (3) the micronutrient treatment group contained 3 patients with diabetes mellitus compared with zero in the placebo group (P = 0.09).

It is technically correct that most of these differences were not statistically significant, but, look at the results:

The mean absolute CD4 count increased significantly by an average of 65 cells in the micronutrient group versus a 6-cell decline in the placebo group at 12 weeks (P = 0.029)

CD4 counts vary quite a bit, and are an imperfect measure of disease activity and immune function. As we can see from his groups, there was a very large range of CD4 counts in each group at the start. An average change in CD4 count of 65 seems anemic at best. Kaiser is more optimistic:

This study demonstrates that a micronutrient supplement administered to HIV-infected patients taking stable HAART significantly enhances CD4 lymphocyte reconstitution. Our findings support the potential for a broad-spectrum micronutrient supplement to be used as adjuvant therapy in combination with HAART to provide patients with a more robust CD4 cell rebound after initiating antiretroviral treatment.

I find the data from this pilot study entirely unconvincing. His conclusions are hyperbolic and premature. That's not unusual, though. Researchers sometimes get a bit excited about their work, and as an inexperienced author, perhaps he can be forgiven for a little unrestrained enthusiasm.

But it gets a bit more interesting that that. In a letter to the editor, a careful reader noted something unusual. A patient showed him a brochure claiming that K-PAX could raise CD4 counts by 26%. K-PAX, it seems, is the same product used in Kaiser's study. The writer was concerned:

Most disturbingly, the first author on the paper, Jon D. Kaiser, MD, seems to be the same person mentioned in the brochure as the developer of K-Pax Vitamins.

Given the recent controversies at other medical journals about the failure of authors to disclose potential conflicts of interest, I am sure that this article would not have been published without disclosure (or at all) if the Editors had been aware of the conflicts of interest in this case.

There is a long, sordid history of conflicts of interest in published research. Some drug companies have gone so far as to print their own faux-journals containing only favorable studies. That is why most journals have strict disclosure rules for conflicts of interest. A study being sponsored by a drug manufacturer does not invalidate it, but failure to disclose this connection is unethical and problematic on many levels.
Kaiser was (correctly) allowed to respond:

After reporting the improved immune reconstitution of patients taking the micronutrients plus highly active antiretroviral therapy (HAART) to the Bristol-Myers Squibb team, I anticipated that they would show interest in pursuing the development of a therapy that had the potential to act as a safe and beneficial immune modulator.

On learning that they had no interest in pursuing the development of this compound, I chose to form a company, K-PAX, Inc., to keep the micronutrient supplement in production and make it available for sale while I worked to get the study results published.

I neglected to inform the Editors of this journal of this conflict of interest and any potential bias that existed during the paper's submission and publication process. Nor did I inform the other authors on the paper of my financial interest in the company. They received no personal compensation for their efforts.

In other words, he is the guy who makes and sells K-PAX, and he owned up to failing to disclose this profound conflict of interest. I asked Kaiser through his publicist about this. His response was less conciliatory:

This research study was performed before there ever was a company or financial interest in a product (2001-2003). The data were analyzed by an independent Data Analysis Firm selected by Bristol-Myers Squibb in 2001. The JAIDS editorial board performed a thorough evaluation after Dr. Smith raised his concerns and found no evidence that either the data analysis or study conclusions were inaccurate.

I'm unimpressed by this response.

As I've said many times in this space, being wrong is not a moral failing---being deceptive is. Many doctors who offer unproven therapies are genuine in their beliefs that they are doing good. This doesn't change the fact that promoting unproven treatments is a bad thing. A doctor should know better than to use hyperbolic language to convince HIV patients that he somehow has the answer to their disease, an answer that no other specialist has. Of course, most doctors have a lot more formal training that Dr. Kaiser, so perhaps he can be forgiven for his hyperbolic promotion of a single pilot study as a major breakthrough in HIV treatment.

Right?

Coming up at WCU

Sun, 07 Mar 2010 18:30:44 -0500

For some reason I'm really excited about tomorrow's post. I don't usually write very far ahead of time, but this one took a little bit of extra research. You see, I got this letter from a PR firm hyping some altmed doc, and it was much more interesting than the usual similar things I get. It highlights some of the subtleties at the intersection of science-based medicine and the other stuff.

The post is going up here tomorrow morning, and at Science-Based Medicine in the afternoon.

One thing I've found about blogging, though, is a piece I really work hard on and like a lot may go over like a real dud, and a post I crank out in five minutes may end up with more hits than I've seen in months. Go figure.

Friday writer's block open thread

Fri, 05 Mar 2010 15:37:43 -0500

Things have been rather busy at Pal's place. For whatever reason, the complexity of patients has been pretty high lately, so I haven't had a chance to get in my usual once or twice a day post.

I'm told that "back in the day" internal medicine patients were a bit less complicated. These days, to get admitted to the hospital, you have to be pretty damned sick. The hospital has to be able to justify your admission based on "severity of illness" and "intensity of service". In simple terms, you have to be sick enough to need care that cannot be provided elsewhere. The days of being admitted for "rest" or for "a workup" are gone.

It's not uncommon for a typical hospitalized patient to have several illnesses, and for the treatment of one to be incompatible with the treatment of another. Many, many patients are treated with various sorts of medications to prevent blood clotting. People with a common heart rhythm problem called atrial fibrillation are usually on a potent anticoagulant called warfarin. Patients with drug-eluting stents in their coronary arteries are often treated with an anti-platelet drug called clopidogrel. If a patient on these drugs develop gastrointestinal bleeding---a common enough problem even without blood thinners---treating them becomes a real dilemma. Stopping the blood thinners may lead to devastating clots, but failing to may lead to life-threatening bleeding.

Patients with atrial fibrillation may have a risk of stroke as high as 8-10% per year, a risk that can be cut in half with warfarin. The risk of severe gastrointestinal bleeding is lower than that (depending on a number of factors), but it still happens. Given this, we're going to see a lot of people with atrial fib in the hospital, either for GI bleeding or for stroke (not to mention for control of the arrhythmia itself).

All this is my way of saying medicine is never boring. But it's sometimes busy.

In addition to hospital rounds, I'm going to a birthday party for a five year old buddy of my kid. Other than that, who knows?

So, what are you up to this weekend?

Hey, guys, this one is for you

Wed, 03 Mar 2010 15:49:57 -0500

Sexual violence is a huge problem in the US. Among college-age women, for example, 20-25% report an attempted or completed rape while in college. Assault itself is prevalent enough to constitute a major public health problem, but add to that the sequelae---STIs, PTSD, fear, etc.---and sexual assault isn't just a major public health problem; it's one of our most common and devastating public health problems.

Given that most perpetrators of sexual violence are men, we have a target population for prevention. Now, some might argue that focusing on preventing sexual violence by educating men is the wrong approach. After all, why not teach women how not to get raped. Right?

This common argument is one of the reasons we men need education. So let's take a few minutes, guys, and go over a few things, things I've spent a lot of time trying to learn and to understand.

The famously profane blogger Physioprof has a terrific post up. In his piece, PP describes receiving criticism from a colleague:

My immediate reaction to his e-mail was, "Fuck you! These specific aims kick fucking ass! And what the fuck do you know, anyway?" This is everyone's immediate reaction to substantial accurate criticism. Having experienced this a fuckthousand kajillion times, it took me only about 100 milliseconds to sack the fuck up and feel extremely grateful for his penetrating insights. (emphasis mine)

This sort of reaction to criticism really resonated with me, as I'm guilty of similar reactions; I work hard to get past my own love for my strongly held opinions. I don't always succeed, but I try to learn from people who know more than I do.

When our attachment to our own biases actually harms others, we have a special responsibility to work toward breaking down our walls of ignorance, walls that are often built of our own needs and our own privilege.

This was made especially clear to me in Dr Isis' recent post about sexual assault. In the comment section, there was a predictable response from many (male) commenters who became very defensive (and often offensive). I read many of the non-offensive commenters carefully, trying to learn. It can be very difficult as a man to understand the sense of threat or fear experienced by women in many situations, but that doesn't mean it's impossible. How can we men begin to understand the important issues surrounding sexual violence, thereby helping to prevent it?

It is important to realize that it isn't about your feelings as a man, but your behaviors as a man. When a woman says, "that comment about my appearance made me uncomfortable," that is not your cue to say, "I didn't mean anything by it," or "you shouldn't be offended by my harmless act." This isn't about your discomfort. It's about a woman feeling uncomfortable and maybe threatened. You have no way of intrinsically knowing if your own act is "harmless" or "non-threatening". For all you know, the woman who you just patted on the back and gave a complement to got the same treatment from her rapist last year. In fact, many rape victims are forced to share the same environment with their rapists and might be a little suspicious of an "innocent" glance or touch.

But all of this is a bit too specific. The point is, men need to man-up. We need to take responsibility for sexual violence. Women, who make up the majority of sexual assault victims/survivors, are not responsible for our behavior---we are. If you say and do things that make a woman uncomfortable, this is not the time for you to hone your debate skills. You don't get to decide if a woman feels threatened. You just need to stop, and do better next time.

Running out of pigeons

Mon, 01 Mar 2010 16:21:51 -0500

Here in the U.S. our rich are very rich and all but our poorest live better than most Haitians. In this context it's easy to lose perspective and to be a bit naive about the survival needs of the people in post-quake Haiti.

Or maybe that's being too generous. How hard could it be for an adult to realize that finding food, water, shelter, and basic medical care for yourself and your family take precedence over any other needs? Does it really take being subjected to life-threatening conditions yourself to have such a basic level of empathy?

The hordes of medical cultists descending on Haiti probably represent both ignorance and frankly cynical self-promotion. There have been many reports of the Church of Scientology's faith healers walking around in yellow t-shirts trying to "assist" people's nervous systems. Homeopaths, the folks who sell water panaceas, have been offering to "help" as well.

Poor and less-industrialized countries are a target-rich environment for alternative medicine cults. Since many alternative medicines don't require an industrial base, they can be made readily available anywhere. Homeopathy is just water; if a homeopath can simply provide a water remedy that contains fewer fecal coliforms than the local water, they can get away with quite a bit before people realize they've been duped. In fact, unless a population has had exposure to real medicine, the altmed folks can fool people for a very long time. But hungry people can also be very pragmatic, and they know that eating grass will only give a false satiety. The same may be true of medical help.

When faced with an immediate threat to life and limb, most people find out rather quickly the difference between real and fake medicine. In rich countries such as the U.S., people have the luxury of indulging in alternative remedies. We have good public sanitation and vaccination and so suffer more from diseases of excess rather than those of desperate poverty. If you have access to food and clean water, so much that you even consume to excess, then you may have time to explore fake cures. But when the world falls down around you and your children are crying for food, everything changes.

Fellow med-blogger Orac tipped me off about a story in Canada's national paper the Globe and Mail about a Windsor, ON naturopath who took off for Haiti to offer his idea of help. Canada seems to have a serious naturopath problem. Naturopaths in Canada tried to co-opt the flu pandemic with a worse-than-misleading educational campaign, and have made in-roads into getting the same rights as real doctors (without the concomitant responsibilities---we real doctors have to have at least some evidence on our side).

So it was with no small amount of Schadenfreude that I read about a naturopath's failure in Haiti (but also sadness for the Haitian people for being subjected to him). Denis Marier, a naturopath practicing not far from me, took his altruistic impulse and a whole lot of fantasy and boarded a plane for Hispanola. His particular medical fantasy seems to be centered around vitamin C.

I'm also trying something new this mission - intravenous vitamin C injections to assist with tissue and wound healing. I don't have access to refrigeration, but should be able to keep the vitamin C, calcium, magnesium, selenium and zinc stable for a few days. I've brought enough from my clinic to give approximately 100 treatments of 5 grams of vitamin C plus support minerals.

Well, I'm sure that vitamin C will fix up those traumatic amputations just fine. And with neonatal tetanus, it sure couldn't hurt, right? I'm sure he cleared his "trying something new" with the appropriate human subjects committees and with the Haitian health authorities. Right?

The elderly lady with the maggots in her sinus cavity from an earthquake injury went to surgery today - she's expected to recover well. I'm hoping the IVC administered over the last several days, as well as the homeopathic (Pyrogenium) have contributed to her positive prognosis.

You can hope all you want, but unless devitalized tissue is debrided, no amount of magic water will help. In an unsanitary environment like a disaster zone, any extra skin punctures simply add to the risk of infection, so rather than being simply useless, Mr. Marier's medicines are likely to cause additional harm. The Haitians seem none too impressed with Mr. Marier anyway:

Unfortuantely (sic), as I've experienced on previous missions, the local community is arriving at a free "medical clinic" expecting medications, not homeopathic remedies to help with post-traumatic stress from the original disaster.

Those pesky Haitians! Coming to a medical clinic expecting medical help! You'd think centuries of crushing poverty would have sucked the hope out of them by now, but apparently they still expect medical clinics to practice medicine. According to the Globe and Mail report:

After he saw two patients the lineup just melted away... Before he [Marier] left, he disposed of the leftover injectable Vitamin C he brought with him from Canada (it's a new-ish remedy, apparently, to stimulate tissue healing) because he was worried that, in his absence, it would be used improperly. When I left him, he was also contemplating disposing of a huge load of traumeel, a homeopathic anti-inflammatory.

For fuck's sake, this guy takes a bunch of suffering trauma victims, subjects them to medical experiments, and then worries his magic potions may get misused? It's too bad the Haitian cops were too busy rounding up baby-snatchers to go after guys like this.

Are animal rights activists violence fetishists?

Thu, 25 Feb 2010 17:32:34 -0500

Ambivalent Academic made a fascinating observation today about certain parts of the animal rights movement:

What really strikes me is that a lot of this rhetoric reads like snuff-porn.
[...]

There is an undercurrent of appetite for the kind of violence they describe. It reads as if they take pleasure in imagining the violence they describe,... and they are inviting the reader to join in that sadistic pleasure. You can almost hear the drool.

I'm sure any sophisticated psychiatrist might have made this sort of observation, but I'm not even an unsophisticated psychiatrist. The images and language at websites such as Camille Marino's is violence-obsessed, and, as AA put it, almost erotic. Marino's loving and frantic depictions of violence are pornographic. Her enemies are portrayed bound, naked, and bloodied. Her use of words and image manipulation is full of masturbatory zeal.

And I don't think she is unique in this. Animal rights activists revel in violent imagery and language like very few other activists movements (save, perhaps, the anti-abortion movement). Their fantasies are far more disturbing than any slaughterhouse or laboratory.

Animal Rights Terrorists Target Children

Wed, 24 Feb 2010 11:52:21 -0500

I have this friend. She used to be a scientist, but changed fields, earning a Ph.D. in philosophy. She now studies and teaches the ethics of the practice of science. I'm sure most of my readers understand how important this is. Without transparent, thoughtful, and informed discussions of ethics, the practice of science and medicine would be a disaster. The past has seen many egregious practices, such as the Tuskegee Syphilis Study, Nazi medical experimentation, and the historical abuse of the poor and minorities by science, but ethical dilemmas and disasters are not a detail of history. Many of the historical abuses in the name of science and medicine, for example experimentation on prisoners and the mentally ill, were normative at the time. This doesn't make them right, but it provides context, and reminds us that some of our current normative practices may later be judged wanting.

Ethicists don't simply sit around a conference table discussing useless theory (although I'm sure they do from time to time). They help develop policies and solve problems. Ethical questions arise as a natural course of my work as a physician, and being able to consult experts not only helps me, but helps my patients.

As an ethicist, Janet Stemwedel isn't afraid to get her feet wet. She recently participated in a dialog about animal research at UCLA. One of her rewards for lending her expertise to this effort was to have her picture, name, and contact information posted on animal rights websites. In case you're not familiar with the level of dialog appreciated by many animal rights activists, here is some of the text from a posting with Janet's name and picture:

We don't think a 'forum' will dissuade ANY vivisector from continuing to torture animals, since they are making so much MONEY from doing so. But UCLA Bruins for Animals seems to think a "discussion" will help these poor, abused, imprisoned animals and we guess it takes every spoke in the wheel for change to occur.

[...]

If the nonhumans could fight back, their tormentors would have expired long ago. We have an obligation to expose the abusers. It is the LEAST we can do!

The hypocrisy of these groups is infinite. To change the way our society views animal research, you have to actually convince society that your position has merit. You can't (morally) force it on anyone through threats and violence. The animal rights crowd knows this, and they know that they are nowhere near convincing a significant number of people. Since they have failed at dialog and debate, they have switched to terrorism, and targeting researches isn't enough for them---now they are targeting children.

As the pictures indicate, neighbors came out from many of the near-by houses, took leaflets and talked to activists about how much they hate their neighbor Dario for doing "hellish primate experimentation." One, in fact, gave an activist the name of the school one of his offspring attends! Activists plan on legally leafleting the school in order to educate fellow students what their classmate's father does for a living.

A couple of details are worth noting here. Terrorists and others who encourage violence and murder often dehumanize their victims. In this plea to harass a scientist's kids, they refer to Dr. Ringach as "a mobster for some drug cartel, (although mobsters don't commit nearly the gruesome, hideous things to innocent beings as Dario does to primates on a regular basis.)" After re-branding a human being as a gruesome criminal who harms "primates", the terrorists refuse to refer to his kids as "children" instead labeling them "offspring". Reading it, you get the distinct feeling that his children will next be referred to a "vermin".

And where are the "mainstream" animal rights groups on this? Are they engaging in dialog so that their "rational" voices will win them support and drown out the violent rhetoric of the extremists?

Of course not, because while many people may have legitimate concerns about animals used in research (not least the scientists working with them), the core of the animal rights movement is about fear. It is about leveling the status of human and non-human animals, not by elevating non-human animals, but by de-humanizing people, making them legitimate targets for violence.

Animal rights groups are among the most dangerous domestic terrorists in the U.S., and anyone who works for "animal rights" needs to recognize this. If your aims overlap significantly with those of terrorists, you must re-examine your position, and if you still hold it, make very clear that you are for something other than destruction and fear.

Addendum:

Janet Stemwedel points out that the animal rights group that co-sponsored her dialog has taken a public stand against violence and intimidation.

Platelet rich plasma

Tue, 23 Feb 2010 15:35:33 -0500

Several months ago, Dr. Val Jones wrote about a growing fad in the treatment of musculoskeletal disorders. The therapy, called platelet rich plasma (PRP) injection, involves taking a small amount of blood from a patient, spinning it down in a centrifuge, and then injecting the plasma component into...somewhere. This treatment is becoming increasingly popular, and can be very lucrative for doctors. But does it work?

Blood platelets are very biologically active particles and plasma is not a bland fluid. Platelets and plasma contain many biologically active molecules, some of which may be implicated in "healing". This gives PRP at least a veneer of plausibility, but like any other treatment, plausibility is only the first step.

There have been a few human studies of PRP. A recent article in the Journal of the American Medical Association (JAMA) showed no difference between PRP and saline injections for chronic Achilles tendon problems.

A small pilot study looked at PRP for the treatment of a particular periodontal disease, and found some possible benefit.

Another interesting study looked at PRPs affect on the healing of anterior cruciate ligament (ACL) grafts in the knee. This study included long term (two year) follow up, and found no benefit.

And that's really about it. There is little evidence to support platelet rich plasma for the treatment of anything. And yet it is being hyped and sold everywhere as a miracle cure for musculoskeletal injuries. Perhaps more studies will enlighten the issue further, but at this point, PRP is nothing but expensive snake oil, and those who promote and use it should re-examine the data and their ethics.

References

de Vos RJ, Weir A, van Schie HT, Bierma-Zeinstra SM, Verhaar JA, Weinans H, & Tol JL (2010). Platelet-rich plasma injection for chronic Achilles tendinopathy: a randomized controlled trial. JAMA : the journal of the American Medical Association, 303 (2), 144-9 PMID: 20068208

Markou N, Pepelassi E, Vavouraki H, Stamatakis HC, Nikolopoulos G, Vrotsos I, & Tsiklakis K (2009). Treatment of periodontal endosseous defects with platelet-rich plasma alone or in combination with demineralized freeze-dried bone allograft: a comparative clinical trial. Journal of periodontology, 80 (12), 1911-9 PMID: 19961374

Nin JR, Gasque GM, Azcárate AV, Beola JD, & Gonzalez MH (2009). Has platelet-rich plasma any role in anterior cruciate ligament allograft healing? Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association, 25 (11), 1206-13 PMID: 19896041

Just because I wouldn't do it...

Mon, 22 Feb 2010 20:05:30 -0500

I've written previously about my decision not to assist patients in obtaining medical marijuana. My decision is based on my interpretation of the data and of medical ethics. This decision is independent of any opinion I may have about legalization.

But other doctors may see things differently. The data are clear to me, but the plausible nature of many of the claims made about marijuana make it anything but a no-brainer.

That's one of the reasons why a story out of New Mexico is disturbing. New Mexico has a medical marijuana program. Doctors who work for the Veterans' Administration are being told the following:

General Counsel has held that: "VA should not authorize completion of forms seeking recommendation or opinions regarding" participation in medical marijuana programs and that "applicable statutes and regulations do not require VA physicians to complete such forms."
Further "A VA physicians' completion of a form that would permit a patient to participate in a state medical marijuana program could result in DEA action to seek actual or threatened revocation of the physician's registration to prescribe controlled substances as well as criminal charges."

The language in the New Mexico form requires physician certification that "the potential health benefits of the medical use of marijuana would likely outweigh health risks for the patient." Informal advice received from the DEA suggests that the Department of Justice may seek civil or criminal penalties for Federal physicians and other practitioners who complete forms that either recommends the use of medical marijuana or forms that describe the patient's physical condition in order to facilitate the patient's entry into a state medical marijuana program.

New Mexico law permits medical marijuana with a doctor's certification. The VA is claiming that a doctor's status as a federal employee supersedes all other considerations. That is disturbing.

I have no doubt that there are doctor's out there running pot certificate mills, but I doubt they make up the majority of those filling out pot certificates. The Feds have created an ethically untenable situation. If state law allows a doctor to certify someone as benefiting from pot (not prescribing it), and the doctor truly feels the data support this certification, who should bend? Many veterans get all of their care from the VA system.

An analogy could be made that since heroin is an excellent analgesic, doctors should be allowed to prescribe it, and while this analogy is tempting, marijuana, for social, legal, and scientific reasons, is not perfectly analogous to other narcotics. Any physician certifying someone for marijuana use should be aware that the data are thin, and that health risks, including addiction, are real. But this comes very close to forbidding a doctor from giving advice as they see fit.

Clinical Marijuana Research Update

Mon, 22 Feb 2010 14:28:31 -0500

Human beings are fundamentally narcissistic, and this narcissism can be antithetical to good science and good medicine. We place far too much confidence in our individual abilities to understand what happens to us, and we place far too much importance on our own experiences, inappropriately generalizing them. That's why science is so important in medicine---to avoid basing life-or-death decisions on something some guy thinks he might have heard once.

In my recent piece on medical marijuana in Forbes, commenters took me to task for what they perceived to be a host of errors in my reasoning. Some of these deserve to be specifically addressed, but not before a summary of the topic.

Marijuana's legal status is a political issue, not a scientific one. I will leave the politics to those cursed with such things. But I'm responsible for medical decisions, and as much as is possible, I have to look at data dispassionately. I have no doubt the individuals find marijuana beneficial for a wide range of problems---this may be a basis for study, but is not adequate data to prescribe a powerful pharmacologic agent.

In 2000, the University of California established the Center for Medicinal Cannabis Research. This month, they released a summary of results to date.

The federal government has historically made it very difficult to study marijuana. The state of California, though specific legislation, was able to encourage a significant amount of research into the clinical use of marijuana, and this month's report is a summary of their work to date. So far CMCR has produced four published clinical studies and one poster/abstract.

The first study, by Abrams, et al, deals with painful HIV-associated sensory neuropathy (HIV-SN). This is a painful condition that can be caused by HIV infection or by certain treatments for HIV. This is a good place to start, as current treatments are disappointing. The study enrolled 55 patients with HIV-SN, and randomly assigned some to smoke real joints, and other to smoke joints with the cannabanoids extracted. Fifty patients completed the five-day study, with some encouraging results, but there are a few problems. First, it's unlikely that patients remained truly blinded to their assignment (unless they though the treatment group was given Grade F ditch weed). The authors recognized that unblinding might have been a problem. The authors also made an attempt to compare their data to studies of other drugs for this condition, but they did not compare cannabis directly to any other drug, including opioids.

This is a small study, and since the number needed to treat (NNT) found in this study and studies of other drugs was not dramatically different, head-to-head studies of marijuana, opioids, and standard drugs for this condition would be very useful. Given the benefits of opioids in a variety of pain conditions, including neuropathic pain, it would be important to compare the benefits and negative effects of opioids vs. marijuana. Finally, the authors concluded that the drug was generally safe during the five day study, as there were no major adverse events requiring subjects to drop out. I'm not certain this is a fair interpretation:

No patient withdrew from the study because of adverse events. One episode of grade 3 dizziness related to study medication occurred in the cannabis group. One case of transient grade 3 anxiety possibly related to study medication was reported in each group. Both patients received a one-time dose of lorazepam.

These patients required a second medication to treat the symptoms of the drug. This may or may not be significant when compared to the level of pain relief or when compared to other drugs, but it cannot be concluded that the drug was entirely safe and well-tolerated, especially given what may be observed when there is more than 125 person-days of exposure.

A second study by Ellis, et al, also looked at painful HIV-related neuropathy, and addressed some of the issues with the Abrams study. This was also a small pilot study, but used a crossover design. The authors actually surveyed the subjects to see if they remained blinded, and by the end of the study, many subjects "knew" which toke was placebo and which was the good stuff. They also explicitly addressed one of the interesting questions that comes up in relation to marijuana research.

Because of funding mandates, these studies used smoked marijuana. Given the likely harm of long term smoking of anything, Ellis brought up the need to study non-smoked cannabis. Boosters often promote smoked cannabis as having "special" properties not available in extracts and derivatives, something these two studies, which each contained de-THC'd fatties, argue against.

More important is that while these results are encouraging, they are not enough to make a clear medical recommendation. Two small pilot studies are not sufficient to make significant clinical recommendations. They may give us good reason to study the use of marijuana or its derivatives for the treatment of HIV-related painful sensory neuropathy. Hopefully future studies will include comparisons to standard therapy, and clearer evaluation of long-term effects of marijuana ingestion in these patients.

References

Abrams DI, Jay CA, Shade SB, Vizoso H, Reda H, Press S, Kelly ME, Rowbotham MC, & Petersen KL (2007). Cannabis in painful HIV-associated sensory neuropathy: a randomized placebo-controlled trial. Neurology, 68 (7), 515-21 PMID: 17296917

Ellis, R., Toperoff, W., Vaida, F., van den Brande, G., Gonzales, J., Gouaux, B., Bentley, H., & Atkinson, J. (2008). Smoked Medicinal Cannabis for Neuropathic Pain in HIV: A Randomized, Crossover Clinical Trial Neuropsychopharmacology, 34 (3), 672-680 DOI: 10.1038/npp.2008.120

Inevitabilities

Mon, 22 Feb 2010 08:15:05 -0500

Every morning I get to wake up my daughter and get her ready for school, but often that's the last time I see her until the next day. The other day, my wife took her out of school to go to the dentist (apparently the entire school became aware of this just after my daughter). Despite her initial boisterous objections, she did quite well at the dentist, and thanks to technology, I was able to share in the experience---my wife sent me an MMS of my daughter showing me her three loose teeth.

My baby. Losing her baby teeth. This. Isn't. Cool.

But she's excited, and she should be. No matter what I may wish, she will keep growing up. Certain things are inevitable.

Most nights I don't come home until about 9:30, well after the little PalKid has gone off to sleep. But she knows that Tuesday nights belong to us. I come home early, and we either go out as a family, or I take her out to a little sushi place down the street. My schedule is regular enough, and she is rigid enough, that when there is a change, she knows it. A week or so ago, I took the morning off to be with her on a snow day. Her cousin slept over, and after making them Daddy Waffles, we suited up and went sledding on the front lawn, with its dangerous 2 degree slope. She couldn't believe I was there to push her on the sled.

Every second with the kiddo is precious, from cuddling on the couch, to clipping her nails while she turns on the drama. So the other night when I went to pick her up at her little friend's house and she begged me to let her sleep over, I wouldn't let go.

"Are you sure you don't want to come home and cuddle?"

"Daddy, I want to sleep over! Pleeeeeease?"

The damned kid is losing her teeth, sleeping over at her friend's house, and generally growing up like a normal kid. I guess I'm going to have to be OK with that. But the house sure was quiet the next morning.