Archive for the 'Medicine' category

Dr. Pal, why do you love Big Pharma so?

Aug 24 2011 Published by under Medicine, Uncategorized

After my recent post attacking the journal Cancer which published a horrid piece on quackery, a twitterer asked me question: "Why do Sci writers go in harder on quacks than pharma?"  (I think this begs the question; I don't believe that we neglect abuses among Pharma, but let's pretend that there is data to support her assertion). She continues, "My problem with selectively trashing these studies is we presume pharma studies better-so our audience does, as well. All quackery should be pilloried yet we selectively pillory the faith healer & homeopath. Why? B/C they're easier targets."

Assuming, once again, that her assertion is true, there are a number of good reasons to focus on blatant quackery above corporate malfeasance.  The pharmaceutical industry, while motivated primarily by profit, is required to go through extensive scientific testing of plausible drugs and devices.  This process is long, expensive, and is frequently successful at actually fighting disease.  There have been many infamous cases of burying data, of inappropriate promotion of drugs, but in general, science has won; sometimes it takes years, and sometimes there is harm done, but eventually, ineffective drugs, or drugs whose risk/benefit ratio is horrible tend to die.  There are of course exceptions, but not many.  The very fact that drugs have been given post-marketing black box warnings or have been withdrawn from the market (sometimes despite the work of bad actors in industry) is a marker of the ultimate success of the system.

This happens because science and medicine is designed to look for faults. Sure, the system can be gamed by dishonest players, but the scientific community is more than willing to toss out a modality that proves itself wanting.  Medical science, while influenced by ideology, is not ruled by it.

So-called alternative medicine and quackery works in a completely different way. Rather than asking a question and accepting an answer good or bad, altmed comes up with an answer and no amount of data will  cause it to be abandoned.  Despite hundreds of years of ineffectiveness, homeopathy is still used.  Despite its utter implausibility and proven inutility, reiki is still practiced.  There are very few if any altmed modalities that have been abandoned because of unfavorable data.  They are ideologies rather than science.

It is science and plausibility that separates quackery from real medicine.   Pharmaceutical companies develop and test hypotheses.  Sometimes they behave badly, but generally they have been successful at helping us live better and  longer.  There is an entire legal infrastructure in place to prevent them from doing ill, and to punish them when they are caught.  This system is far from perfect but it does work.

No system is in place to regulate or punish those who sell snake oil, and since patients are often "true believers" they are unlikely to sue quacks.

It's not a matter of choosing to go after quacks rather than pharmaceutical malfeasance.  We do speak out about it; there is a regulatory structure in place to monitor pharmaceuticals, as imperfect as it may be; and pharmaceutical science is science, whereas quackery is simply immoral, made up practices profiting off the hope of people who hurt.  It deserves every smack-down we can deliver.

 

3 responses so far

Of douches, online identity, and ethics

Aug 22 2011 Published by under Medicine

We need to have a little talk, you and me.  There has been a lot going on here on the internet in the last few days, most of which I've been unable to comment on more than briefly due to a vacation far from well-lubricated intertubes.  This evening, let's pull a nice demitasse and see if we can sort out some of this insanity.

Every morning, whether I need it or not

First, a well-respected internet health writer nearly lost his job for his online activities. Whether or not this was a good legal choice by the blogger's employer is nearly irrelevant.  As often happens on the internet, the writer got involved in a heated discussion with some psycho, thin-skinned reader (all simply my opinion of course) who then contacted the state entity by whom Our Hero is employed.  Perhaps not wanting to be linked with the word "douchebag" used in a non-official context, they told Our Hero, "can it or leave."

There are a number of important lessons here.  First, pseudonymity is your (non-legal) right; keeping the pseudonym from being cracked is not.  While outing someone's online identity may, in fact, be "douchey", it's not illegal.  And whether or not one's employer is behaving strictly within the law in firing your profane behind, the trouble stirred up is, in the real world, real, and you will probably lose.  It is therefore wise to remember that what you say online will quite likely be linked to your real name some day.

In addition to any avocational blow-back from internet discussions, there  are ethical concerns, especially to those of us in health care.  During a twitter meet up last night, I made a comment about medical ethics and social media and got a well-justified (though polite) query from a participant wondering what I was talking about.

Before answering her question, though, let's explore a "speech" issue here.  I know nothing---nothing!---about the law.  But what, from a non-legal perspective, makes an online discussion any different than one at a cocktail party?  If I were to call someone a "self-important, ignorant douchebag" at a party, would the target of my derision be justified in calling my employer?  Would my employer even take the call without laughing?  Is it the lasting nature of online writing, the public context that makes it more seemingly "harmful"?  If the exchange had taken place via email rather than on-blog would that have made a difference?

From the standpoint of protecting oneself, no.  If someone chooses to harass you for something you say and your employer decides to take them seriously, you're out of luck unless you have legal recourse, but even if you do, your job, while still technically in existence, may be made impossible to perform.  But what is said on open forums on the internet is enduring and is, at least potentially, available to a wide audience, making a claim of defamation (or whatever legal term is appropriate) more plausible to this lay person.  Still, the whole thing is pretty douchey.

In health care, though, everything changes. When I spent a larger percentage of my time teaching, I would give a yearly lecture to the medical residents about social media and medical ethics.  First there is a legal layer to all communications about patients.  The Health Insurance Portability and Accountability Act of 1996 (HIPAA) makes privacy a top concern.  Any "protected health information" (PHI) can be disclosed only under certain circumstances.  For example, if you want life insurance, you will sign a release allowing them access to all of your health information.  You don't have to sign, but they don't have to sell you insurance.  But once given that information, they cannot turn around and give it to your employer, your mom, or the New York Times without your explicit permission.

Doctors like to talk about cases, and HIPPA does not prevent this (once again, I'm no legal eagle), but the case should be discussed for "treatment purposes".   Also, doctors frequently talk about interesting cases simply for educational purposes.  Since there is rarely need to identify the specific patient, privacy is not usually violated.

But with the explosion of social media, these discussions are no longer limited to doctors' lounges.  I regularly field questions from other providers about the appropriateness (not the legality!) of posting certain information on facebook, twitter, and blogs.  For example, a colleague contacted me about posting an X-ray online for discussion with other providers.  The film was edited so that no patient demographics were visible.  This online venue was, however, a semi-public one, not a closed physician-only forum.  The film was unusual enough, and the temporal relationship to the incident close enough that the patient could perhaps be identified.  I recommended he not post it.

There are many subtle pitfalls for health care professionals online.  If I were to say, "I work in a clinic that treats chlamydia," this would differ from saying "I treated a lot of chlamydia in my clinic this month," which is also different from saying, "Last night I treated a horrible case of chlamydia."   Each statement brings me closer to having potentially revealed someone's protected health information.

I have argued in the past (though I can't seem to find the link) that medical ethics should be a pre-requisite for applying to medical school.  Many young doctors have no idea what they are getting into ethically, and some can't handle it.  Social media are the least of these problems, but a significant one nonetheless.  Stressed out medical students and residents want to vent to each other, and it seems natural to do so on facebook and twitter, but it often turns out to be a bad idea both ethically and for one's employment status.

Speech, while free, is not without consequences, and sometimes it's the good guys that get burned.  But we must also consider our own status as being either professionally or socially privileged in such a way that we may behave unethically in our discussions.

5 responses so far

When a "scientific study" is neither

Aug 18 2011 Published by under Absurd medical claims, Medicine

There is quite a bit of art to the practice of medicine: knowing how to get and to give information to a patient, how to create a sense of worry without creating a feeling of panic, how to use the best available science to help them maintain or return to health. Underlying all of the art is the science: what blood pressure is likely to be harmful in a particular patient? What can I offer to mitigate this harm? This science is developed over years by observation and systematic study. We have a very good idea of what blood pressure levels are optimal to prevent heart attacks in various populations. These data are hard-won. It has taken decades and it continues.

If a researcher were to discover a promising, new blood pressure intervention, they would have a long way to go from bench to bedside. They would have to prove as well as possible that it is safe and effective---and from a science-based medicine perspective, that it is even plausible. If the discovery is a drug that relaxes blood vessels, or a type of exercise, we have good reason to believe it might work and can go on to figuring out if it does work. If the intervention is wearing plaid every day, we have little reason to think this would be effective, and it probably isn't worth the time and cost of looking into it.

The well-respected journal Cancer has just wasted space in the study of wearing plaid. Well, not really; it's worse than that. The article is called, "Complementary medicine for fatigue and cortisol variability in breast cancer survivors: A Randomized Controlled Trial." There is nothing that isn't wrong with this study, and if it weren't published in a major journal, it might even be light comedy.

Tragedy wins the day, however, because cancer is a big deal, and I don't like it when people mess around with cancer.

People with cancer suffer from a number of vague and specific discomforts related to the disease and its treatment. Everything from life-threatening blood clots, to intractable pain and nausea, to depression threaten to kill or disable people with cancer. One symptom common to many illnesses is fatigue, and during chemotherapy, fatigue can be debilitating. This new "study" allegedly investigates an intervention to alleviate fatigue.

Fatigue is one of those symptoms whose study can be difficult and deceptive. It rarely has a single cause, is subjective, and waxes and wanes naturally. Because of this natural variability, it is easy to attribute changes in fatigue to an intervention when if fact we may be observing the natural course of the symptom. My patients with colds often want antibiotics. Without antibiotics, their cold will likely last a week or two; with them, 7-14 days. If I give them antibiotics, they will certainly credit me with curing their cold, but were I to take credit I would be riding nature's coattails.

In the current study, the authors have chosen to ride the coattails of nature but rather than cling to them with medicine, they have chosen "biofield therapy". My spell checker doesn't recognize "biofield" and neither should you. The authors at least acknowledge this in passing:

Biofield therapies are complementary and integrative medicine modalities often used by breast cancer patients,
and have been described as therapies that are intended to affect energy fields that purportedly surround and penetrate the human body for the purposes of healing. (Emphasis mine, PalMD)

I have a big problem with studies built around something that only purportedly exists. What's next, a study of cancer rates in Sasquatch?

This paragraph effectively nullifies everything that follows, but what follows is so horrid and humorous that we can't just stop here.

The "biofield healing" technique chosen for the study? "Energy Chelation". It's almost as if they looked for a term that took all of quackery and combined it into two simple words. Nowhere does it tell us what sort of "energy" is being "chelated"; so I looked it up.

According to the study, the technique was chosen by one of the authors, Reverend Rosalyn L. Bruyere. Is she an oncologist? A physicist?

Rosalyn L. Bruyere is an internationally acclaimed healer, clairvoyant and medicine woman.

You don't need to be a capital-S Skeptic to translate that as "con-artist", although that would simply be an opinion. The real question isn't whether or not she is a con-artist (she may in fact be very sincere despite a website that makes her look like a cult leader) but why in the world any real physician or scientist would take such a person seriously?

Still, I want to know what the hell "energy chelation" is. It's not an easy question to answer, but various searches describe it as a hands-on energy healing technique that, analogous to chelation therapy, "chelate" and remove negative energies from the body. In other words, it's a fantasy spun out of happy thoughts and a juvenile imagination.

The "science-y" bit of the study isn't any better, relying of famously inaccurate "saliva cortisol" measurements, and something called "cortisol variability", which does not appear to be a validated marker of the symptom in question (fatigue). From my reading, I'm unclear that it's ever been validated to measure anything.

For all I know, the editors of Cancer are detoxifying themselves in a sweat lodge to rid themselves of the embarrassment of publishing such dreck. I just hope they remember to drink lots of water---faith healers do not have a great track record for patient safety.
References

Jain S, Pavlik D, Distefan J, Bruyere RR, Acer J, Garcia R, Coulter I, Ives J, Roesch SC, Jonas W, & Mills PJ (2011). Complementary medicine for fatigue and cortisol variability in breast cancer survivors: A Randomized Controlled Trial. Cancer PMID: 21823103

(h/t Genevra Pittman at Reuters)

16 responses so far

Dear Patient

Aug 16 2011 Published by under Medicine

I do believe that you are in pain; I can see it in your eyes, your furrowed brow.  I can see it in your hesitant gait, the cautious way you get up and down from my exam table.
But this is the first time I've met you. I don't have your medical records.  I don't know anything about your kidney or liver function, whether or not you have heart disease or diabetes.  You don't know either, which is not unusual.  Many people come to me for the first time without a list of medical conditions or current medications.  We can work it out.

You can expect me to take a thorough history, do a complete physical exam, and request your old records.  But I am not going to give you a prescription for narcotics today.

It's not that I don't believe what you're telling me:  I believe you when you tell me that ibuprofen doesn't work or that you are allergic to it.  I believe you when you tell me that all your other doctors have given you narcotic prescriptions.  But I don't know you yet, don't know your whole medical picture.  Narcotics are potentially beneficial and potentially risky.  Dependence is a disease that is very common, and very difficult to treat.  You should not expect me to take such a risk with your health at this point.

It is possible that your disease, be it chronic pain or opiate dependence or both, does not let you understand that.  You may feel angry, depressed.  You may lose your temper, behave inappropriately.  If I suspect a narcotic use disorder I may offer you a referral to a local expert.

You may not like this, and I may be totally off base, but I have to give the best advice I have, whether you like it or not.  I hope that you will be able to see this as an act of kindness rather than another obstacle in your efforts to get what you think you need.

I will continue to try to help you treat your pain, but I will choose medications for your pain and your other conditions based on what is likely to give the most benefit for the least risk.  Sometimes this treatment may include narcotics, sometimes it will not. All I can do is advise and hope that my advice is good, and that you will follow it to the best of your abilities.

To you health,

PalMD

5 responses so far

Another (nearly) perfect day

Aug 15 2011 Published by under Medicine

As a number of Twitter followers have noted, it's Up North time for the Pal Family. Every summer we spend a week together with whomever can make it up here.  This has been a family tradition since my father was young.  The mid-August weather is perfect: cool nights, warm sunny days, although Lake Michigan is a bit on the cool side this month.  The sunsets, though, are lovely.

One of my readers immediately recognized the spot.  The house we're renting is a short walk from the lighthouse and the beach it guards.

The local fishmonger has been in business for many, many decades.  He sends his boats out every day, and his market and smoke house is packed with the catch.  I just rode up there and picked up some smoked whitefish spread and a few filets.  Dinner will be heavenly.

Sleep, however, may be a bit less relaxed.  I walked into the room to say good morning to MrsPal, enjoying her usual vacation sleep-in and she said, pointing to the bed, "What is that?"

She was clearly expecting another of my bland reassurances, but I did not meet her expectations this time.

I don't like this feller one bit.  Nor do I like his buddies, two of whom suffered the wrath of the nearest PalBook (thankfully I wasn't reading on the Kindle).

A few phone calls, professional visits, and loads of laundry later, we seem to be doing just fine.  It's rare that I've rushed to do laundry so quickly, especially given that our room is on the third floor, the machine in the basement.

No one seems to be reacting to any bites, for which I'm thankful, but when we get home, nothing---NOTHING---is coming into our house without passing through the washer and dryer.

7 responses so far

Spider!

Aug 10 2011 Published by under Medicine

I finally found a use for Google+.  Science writer extraordinaire Ed Yong (rhymes with "song") wondered aloud (as it were) about the following:

1) Are arachnophobes also scared of scorpions? What about mites? They're not scared of insects, right? Crabs?

2) If they're only scared of arachnids, could you use their degree of fear for classification purposes? Are arachnophobes unknowing closet taxonomists?

3) Some spiders mimic ants very well (http://is.gd/pvriwj). If you showed an ant-mimicking spider to an arachnophobe, and they thought it was an ant, would they suddenly freak out if you then told them it was a spider, or would they be okay? Is it the knowledge that something is a spider, or the spidery appearance that's scary?

Aside from the sheer brilliance of the question,  it made me think back to various arachnid-related issues.  While I was up north last week, I had a number of eight-legged encounters.  This guy, for example, showed up on a piece of felt my daughter was playing with:

It's just a dog tick, but it has a big "ick" factor.  The ick factor would have seismically multiplied had it been attached to PalKid rather than a piece of felt.

It seems to have been a banner year for Dolomedes as well.  These guys were all over the place.  I don't like them.  Not one bit.

Despite my revulsion, "dock spiders" are pretty successful predators, snacking on ubiquitous "water skeeters" (striders), and producing many, many offspring.  In all my years hanging around these guys (despite my attempts to avoid them) I've never been bitten, nor have I met anyone who was bitten.  They just aren't that aggressive when it comes to big, hairy (bipedal) predators.

In my practice, patients frequently come to me with "spider bites".  Clinically, these are usually a red welt that is larger than a typical mosquito bite.  That seems to be the sole criterion for calling something a "spider bite".  I cannot recall how old I was when I first heard this little piece of folk knowledge but it was common knowledge on the elementary school playground.  My mother pooh-poohed such bubbe meisehs; "Spiders are our friends," she would say musically as I cowered in a corner of my room waiting for someone to KILL IT!!!!

Despite this widespread belief, most "spider bites" in my part of the country aren't caused by spiders, and probably aren't bites at all.  (The feared "brown recluse" does not live naturally in my part of the country, although importations have been reported.  They do not generally survive through the winter.) The distinction is important for a few reasons.  First, many of us are guilty of wanton arachnicide propelled by our unwarranted fears.  Second, many "bites" are probably bacterial infections and should be treated properly.  Finally, there's my own bias that we shouldn't assume things that aren't so.

12 responses so far

Shame on you, New England Journal of Medicine

Jul 25 2011 Published by under Medicine, Uncategorized

For specialists in internal medicine, the New England Journal of Medicine is one of the journals you really read.  It's not a free throwaway journal or bathroom reading---it's where you find good original research, interesting case studies, cogent editorials.  Usually.  More or less.

Right now it's "less".  A few days ago I posted my review of a recent study on placebos.  I found it interesting but somewhat problematic. It's real benefit seems to have been that it has sparked substantive and vigorous discussions about placebos.   To save you from reading my entire review, the study basically took asthmatics and gave them either real medicine, fake medicine, "sham" acupuncture, or nothing at all.  All the patients reported feeling at least somewhat better, but only the patients treated with real medicine had significant improvement in measured lung function.  Another way to state the findings might be "the placebos and the real medicine all made the patients feel better.  Oh, and only the real medicine made actually better." I have a problem with this presentation as you will read below.

What we've learned about so-called placebos over the years is that "placebo" is not an intervention like a medication or a surgery.  It is an artifact of observation.  A certain amount of change can be expected any time you study a group of people.  "Placebo" is simply all of the change that can't be explained by the primary intervention.  Taking the asthma study as an example, simply enrolling people in the study and doing nothing else caused them to feel a bit better.  But treating them with real medicine caused them to feel better and get significantly better physically.    The bit of "better" that was seen simply by enrolling is referred to as placebo effect, and is a mix of various factors, such as patients' being cared for, regression to the mean, desire to please researchers, and other effects not due to a "real" intervention.  It is likely that a good deal of placebo is subsumed in standard care: if you go to the doctor for a broken leg, being cared for and listened to makes you feel better, but setting the bone and placing the cast does most of the work.  Good doctors maximize our ability to make people "feel" better along with treating the underlying illness.

The current object of my ire is an editorial published in the Journal to accompany the asthma study.  It was written by an anthropologist named Danial Moerman who completely misreads the study, the meaning of placebo, and what a disease actually is.  He first fails to understand that there were actually four interventions:

They found that three of the interventions — active albuterol, sham albuterol, and sham acupuncture — were all equally effective in controlling asthma symptoms, as judged by patient-reported improvement.

[...]

The fourth intervention was “no treatment,” in which patients were told to wait for several hours and then return home. Waiting had no effect on either subjective asthma symptoms or lung function.

Perhaps I misread the results and the graphs, but it appears to me that the "do nothing" group did in fact report feeling better, just not as much as the other groups.   The importance of this lies in the fact that part of the placebo phenomenon is simply being cared for or enrolled in the study (in this case it also involved repeated lung function testing).  If this were subtracted out in some way, we might find a much less significant effect.   But we are still speaking of "subjective" improvement, an important factor, but not one nearly as important as being able to breathe better.

Professor Moerman, perhaps being used to dealing with less concrete ideas, misses the importance of objective vs. subjective outcomes in medicine.  Holding a cancer patient's hand can make them feel better, a lot better in the short term than chemotherapy.   But it won't shrink a tumor.  Moerman thinks we have it the wrong way 'round:

It is the subjective symptoms that brought these patients to medical care in the first place. They came because they were wheezing and felt suffocated, not because they had a reduced FEV1. The fact that they felt improved even when their FEV1 had not increased begs the question, What is the more important outcome in medicine: the objective or the subjective, the doctor's or the patient's perception? This distinction is important, since it should direct us as to when patient-centered versus doctor-directed care should take place.

First, I hate it when people misuse "begs the question", but that's not important.  What's important is that he's asked the wrong question.  It's not whether subjective or objective is most important, or whether a "patient-" vs. "doctor-centered" care (whatever that means) is the best model.   In medicine, we assess both how a patient feels, and how well they are doing physiologically.  We do this in the exam room and we do this in our research.  We (meaning doctors and medical scientists) don't think one is "more important" than the other; we know that any intervention is a balance between changing physiology and making a patient feel better.  Reading this editorial makes me think of Columbus "discovering" America: it was already here, the folks living here obviously knew it, and he really had no idea where he was anyway.

Another example of his profound ignorance is his complete lack of understanding of common medical conditions:

For subjective and functional conditions — for example, migraine, schizophrenia, back pain, depression, asthma, post-traumatic stress disorder, neurologic disorders such as Parkinson's disease, inflammatory bowel disease and many other autoimmune disorders, any condition defined by symptoms, and anything idiopathic — a patient-centered approach requires that patient-preferred outcomes trump the judgment of the physician.

None of the conditions he mentions above are what he thinks they are.  There is nothing "subjective" about the cognitive dysfunction of schizophrenia or the tremors and stiffness of Parkinson's disease.  And there are drugs and other physiologic interventions that improve both the way patients feel and objective measures of how they are doing.

It's not so much Moerman's ignorance that disturbs me: anyone can be ignorant.  But this piece of idiocy was published in one of the world's most respected medical journals.   Well, his ignorance really does disturb me too.  He closes with a false dichotomy:

Do we need to control for all meaning in order to show that a treatment is specifically effective? Maybe it is sufficient simply to show that a treatment yields significant improvement for the patients, has reasonable cost, and has no negative effects over the short or long term. This is, after all, the first tenet of medicine: “Do no harm.”

As a physician and a patient, I'm unwilling to settle for "no negative side effects over the short or long term."   There are no such things as "side effects"; only "effects", some of which we desire, some of which we do not, so risk can only be minimized, never eliminated.   The precept is "First, do no harm", not "Do nothing and hope for the best."

References

Moerman, Daniel E. Meaningful placebos—controlling the uncontrollable. N Engl J Med 365(2):171-172 (2011). DOI:10.1056/NEJMe1104010.

8 responses so far

Asthma, placebo, and how not to kill your patients

Jul 21 2011 Published by under Medicine

A number of years ago I was walking along Lake Michigan with a friend (a fellow medical resident) when she turned to me and said, "are you wheezing?  Do you have asthma?"  I had always been physically active and assumed my breathlessness while walking down the trail was due to the thirty extra pounds of pizza and doughnuts I'd acquired during residency.  But she was right: I was wheezing and breathless and it didn't feel good at all.  I made an appointment with one of the hospital's lung docs who took a good history, did a physical, and ran some pulmonary function tests.  And I did have asthma.  And it felt much, much better when I used proper medication, a feeling confirmed by my improving lung function tests. (Not too surprisingly, the asthma got even better when I lost 40 lbs and started treatment for my acid reflux.)

I still get mild asthma symptoms from time to time, especially when I get sick, but for many others, the picture isn't so pretty.  Asthma kills at least a quarter of a million people every year around the world.   If you've ever worked in an ER and seen a kid with a bad asthma attack, you've earned a healthy respect for the disease.  If you've ever watched your own kid gasping for breath, begging you to make it better, you've learned to fear it.

As our understanding of asthma has improved, so has our ability to treat it (an ability that is strongly linked to a patient's socio-economic status.  Mortality has been rising despite the discovery of better treatments.  Wait: let's pull this out of the parentheses...)...  Asthma deaths and hospitalizations are largely preventable, and disproportionately affect Black and Hispanic Americans.  We know how to treat the disease asthma, but don't know how to treat the people who are affected most.

We understand that asthma is not just a tightening of the airways but also an inflammation that can cause long-term damage.   Not only can we treat asthma, but we have objective ways of measuring how well our patients are doing.   It's easy and inexpensive to measure airway obstruction and response to medications.  We know what works.
For this reason, a new study in the New England Journal of Medicine seems both wise and foolish.

(I thought I was so on the ball.  I really did. But while I was busy riding my bike, playing with my kid, and looking at rentals with my wife, David Gorski and my other medical blogger pals were out in Las Vegas at TAM discussing the very study I wanted to tell you about.)

The study, called "Active albuterol or placebo, sham acupuncture, or no intervention in asthma," was done for reasons that are not clear to me. It may have been done not to test the effectiveness of asthma therapy but to look at what a "placebo" might really be or do.  At least, I think that was the idea.  When reading the abstract and full text, it's not actually clear why the study was done.  At first it seems as if it were done to see why asthmatics treated with placebo improve:

In prospective experimental studies in patients with asthma, it is difficult to determine whether responses to placebo differ from the natural course of physiological changes that occur without any intervention.

Why ask such a question? We know that poorly-treated asthma is deadly, and well treated asthma much less so.  Why do we care about placebo effects here?  The authors explain further:

Placebo effects (i.e., benefits resulting from simulated treatment or the experience of receiving care) are reported to improve signs and symptoms of many diseases in clinical trials and in clinical practice. On this basis, the accepted standards for clinical-trial design specify that the effects of active treatment should ideally be compared with the effects of placebo. Despite this common practice, it is unclear whether placebo effects observed in clinical trials (or those that presumably occur in clinical care) influence both objective and subjective outcomes and whether placebo effects differ from the natural course of disease or regression to the mean.

In other words, the authors want to know what placebos actually do to real people, and they chose asthmatics because they are easy to study (there are symptom-assessment tools for subjective data and spirometry for objective data).   This makes asthma both the right and wrong choice for the study.  It's an excellent model to assess the affect of placebo, but one in which the use of placebo is hard to justify on an ethical basis.

Not surprisingly, they found that "doing something" worked better than doing nothing.  More specifically, they found that any placebo will make a patient feel subjectively better than doing nothing at all.   They also found that all three placebos (sham acupuncture, fake inhaled medicine, and simply being enrolled in the study without treatment) improved objective measures of lung function, but not nearly as much as real medicine (in fact, not much at all).

In other words, simply attending to a patient makes them feel better.  But to get a significant objective improvement (in asthma at least) you must also give them real medicine.  Real medicine comprises both active medications and attending to the patient.  There is no separate "placebo" that can be given to treat asthma effectively.

This is actually a quite beautiful study.  It demonstrates that "placebo effect" is not the same as a real treatment, that real treatment always includes whatever benefit placebo provides, and that placebo is mostly an effect on subjective rather than objective measures of health.  You can't fix asthma with placebo, only with real treatment.  But we've already known that from decades of studying asthma.  So what other justification is there for doing this study?

Our research has important implications both for the treatment of asthma and for clinical-trial design in general. Many patients with asthma have symptoms that remain uncontrolled, and the discrepancy between objective pulmonary function and patients' self-reports noted in this study suggests that subjective improvement in asthma should be interpreted with caution and that objective outcomes should be more heavily relied on for optimal asthma care. Indeed, although improvement in objective measures of lung function would be expected to correlate with subjective measures, our study suggests that in clinical trials, reliance solely on subjective outcomes may be inherently unreliable, since they may be significantly influenced by placebo effects. However, even though objective physiological measures (e.g., FEV1) are important, other outcomes such as emergency room visits and quality-of-life metrics may be more clinically relevant to patients and physicians. Although placebos remain an essential component of clinical trials to validate objective findings, assessment of the course of the disease without treatment, if medically appropriate, is essential in the evaluation of patient-reported outcomes. (Emphasis mine, PalMD)

This is folly.  First, we have a huge literature on quality of life metrics in asthma.  Huge.  And we also know that objective changes in asthma are what save patients' lives.  Yes, I care how my patient feels, but it is not more "clinically relevant" than how they are actually doing physiologically.  Both are important, but not equal.  And the idea that comparing active treatment to placebo is not ideal is not new to researchers.  It's simply that following the natural history of the disease as a "control" is not usually appropriate (cf. Tuskegee syphilis experiment).

No good clinician would consider treating an asthmatic with placebo.  Improper treatment of asthma leads to debility and death.  This study chose mild asthmatics, but I still feel very uncomfortable with the ethics of the study design.  Rather than using a disease we know how to treat to study placebo, we should be finding ways to get treatment to the millions of people who aren't getting it.

References

Wechsler ME, Kelley JM, Boyd IO, Dutile S, Marigowda G, Kirsch I, Israel E, & Kaptchuk TJ (2011). Active albuterol or placebo, sham acupuncture, or no intervention in asthma. The New England journal of medicine, 365 (2), 119-26 PMID: 21751905

7 responses so far

Friday night family follies

Jul 15 2011 Published by under Medicine

A couple of nights ago, a small, warm body crept into bed between me and MrsPal.  Our sneaky snuggler has been mostly keeping to her bed, but once in a while her fears get the better of her.  And sometimes, my fears get the better of me.

A few months ago as my wife lay in a hospital bed trying not to choke on her own vomit I got a call from a friend.

"Pal?  Someone from the breast center just called on MrsPal's phone.  They won't talk to me.  What should I do?"

A few days before her infamously complicated surgery, MrsPal took care of her yearly boob-squishing, but the results hadn't come back before she went under the knife.  As she lay in her hospital bed not recovering, the results became available---sort of.  There was no way I was going to disturb her with anything; we were too busy trying to keep her alive.

I called up the breast center, but predictably they wouldn't tell me anything (and I wasn't about to try to explain that we have documents on file for just such a situation; it would have taken too long).  So I called a breast surgeon and asked her to take a look at the films.  There was a mass that had been stable for years, but now it had new calcifications and more films were needed to get a better look.  As my already fragile stomach dropped further I explained my dilemma, and asked if we could get away with waiting a while.  She felt we probably could.

I didn't tell MrsPal about it.  I kept the mail to myself.  It may have been the wrong decision, but she was so fragile I didn't think she could handle another blow.  But I failed to cover all my bases: once she finally came home, a registered letter came from her OB/GYN with the details. I explained to her my conversation with the surgeon and we agreed to wait a little while longer while she got her strength up.  Her birth mother died of breast cancer, and in the last year or so, two of her friends have had bilateral mastectomies. This was not a great wait.

She finally got her follow up study yesterday, and I called the surgeon back: it all looks benign, no need to worry.  And I didn't.  I thought of my little kiddo who loves cuddling between us, who doesn't deserve any more fear and worry.  I thought of my wife, and how she's finally dodged a bullet.  And I slept.

10 responses so far

The "hCG diet": a fraud literally without substance

Jul 14 2011 Published by under Absurd medical claims, Medicine

Back in the 1950s, a British endocrinologist named ATW Simeons had an idea: a human pregnancy hormone called hCG (human chorionic gonadotropin) could help people lose weight without feeling hungry.  His idea was to put obese patients on a 500 kcal a day diet (in contrast, you probably eat about that much or more at each meal) and give injections of hCG which was supposed to blunt their hunger.  According to his writings, his results were not reproduced by anyone else, which, rather than make him doubt his own hypothesis, hardened his belief that only he could do it right.  Several studies in the 1970s effectively discredited his work, but in the 90's, famous shill and convicted felon Kevin Trudeau published a book that helped revive the hCG diet craze.

hCG has a number of clinical uses mostly related to fertility medicine.  It's also used as a biomarker for pregnancy (it's what we detect on home pregnancy tests) and for certain tumors.  Despite many negative studies in the 70s, hCG has made a spectacular return as a diet fad.   Not only does it not aid in weight loss, but as an active hormone, it may have other unintended effects (for example, it's not known if it can contribute to tumor formation or growth, but it is produced by a number of different tumors).

So put yourself in the shoes of a convicted felon like Kevin Trudeau: you want to continue to sell a weight loss scam, but you want to avoid getting sued if you happen to cause a tumor.  How can you still market the hCG diet without the hCG?  Homeopathy!

A product called KetoMist Spray (not, as far as I know, connected to Trudeau in any way) is purportedly a homeopathic dilution of hCG, that is, there is no hCG in it.  Using it, in conjunction with a 500kcal diet, should be no different than using, say, a spray of water.  The FDA recently came down on so-called homeopathic hCGs  because they are not FDA-approved drugs, nor are they in the "Homeopathic Pharmacopoeia", a list that allows fake drugs to be sold as real drugs.

But hucksters are endlessly clever.  KetoMist appears to skirt the FDA regulations by a bit of sleight-of-hand:

What is in each bottle?
Each bottle contains the 'Energy Profile' of HCG in multiple potencies (6c / 12c / 30c) imprinted onto a solution of Steam Distilled Water (80%) and Kosher Corn Alcohol (20%). If you want to know more about homeopathic remedies, search online - there is a ton of info on homeopathy.Since an 'energy signature' cannot be listed as a physical ingredient (for what should be obvious reasons) it isn't on the 'ingredients list' on the label, but it IS on the label.

In other words, KetoMist "contains" the  same homeopathic ingredient which was banned, but it's called an "energy signature", hoping to avoid the wrath of the FDA and to separate more husky consumers from their money.

hCG does not contribute to weight loss, and ultra-dilute hCG isn't even real---there is no hCG in it.  It's all, in my opinion, more fraud, but if consumers read the fine print they will see the truth:

Legal Disclaimer: The FDA has not approved HCG Therapy to lose weight. “HCG HAS NOT BEEN DEMONSTRATED TO BE EFFECTIVE ADJUNCTIVE THERAPY IN THE TREATMENT OF OBESITY. THERE IS NO SUBSTANTIAL EVIDENCE THAT IT INCREASES WEIGHT LOSS BEYOND THAT RESULTING FROM CALORIC RESTRICTION, THAT IT CAUSES A MORE ATTRACTIVE OR "NORMAL" DISTRIBUTION OF FAT, OR THAT IT DECREASES THE HUNGER AND DISCOMFORT ASSOCIATED WITH CALORIE-RESTRICTED DIETS.”

A tiny but truthful Quack Miranda Warning inserted  at the bottom of the webpage specifically refutes all of the claims in big, bold print above.  But humans are endlessly hopeful, and looking for that miracle.  This isn't it.

References 

Miller R, & Schneiderman LJ (1977). A clinical study of the use of human chorionic gonadotrophin in weight reduction. The Journal of family practice, 4 (3), 445-8 PMID: 321723

Young RL, Fuchs RJ, & Woltjen MJ (1976). Chorionic gonadotropin in weight control. A double-blind crossover study. JAMA : the journal of the American Medical Association, 236 (22), 2495-7 PMID: 792477

Bosch B, Venter I, Stewart RI, & Bertram SR (1990). Human chorionic gonadotrophin and weight loss. A double-blind, placebo-controlled trial. South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde, 77 (4), 185-9 PMID: 2405506

Stein MR, Julis RE, Peck CC, Hinshaw W, Sawicki JE, & Deller JJ Jr (1976). Ineffectiveness of human chorionic gonadotropin in weight reduction: a double-blind study. The American journal of clinical nutrition, 29 (9), 940-8 PMID: 786001

Rabe T, Richter S, Kiesel L, & Runnebaum B (1987). [Risk-benefit analysis of a hCG-500 kcal reducing diet (cura romana) in females]. Geburtshilfe und Frauenheilkunde, 47 (5), 297-307 PMID: 3609673

4 responses so far

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